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Inclusion Criteria: * 18 years or older * Phase 1: Histologically confirmed locally advanced, inoperable, or metastatic tumor; Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma. * For Phase 1 sub-studies: Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma, Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Endometrial Adenocarcinoma, Triple Negative Breast Cancer, Ovarian Cancer, Prostate Cancer * Phase 2: Colorectal carcinoma * No available standard of care therapy or participant is ineligible for standard of care therapy, except in CRC tumor type in which participant must have previously received all the following therapeutic agents: * fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy * an anti-VEGF therapy * if wt-RAS (wt-KRAS and wt-NRAS), an anti-EGFR therapy * Eastern Cooperative Oncology Group (ECOG) ≤1 * Body Weight ≥40 kg. * Female participants of childbearing potential must have negative serum pregnancy test at screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse * Male participants must be willing to use specific contraception and not plan to impregnate a female partner or donate sperm while on study * Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial Exclusion Criteria: * Certain medical conditions such as: active brain metastases, carcinomatous meningitis, unstable angina pectoris, myocardial infarction or clinically significant ventricular arrhythmias, symptomatic congestive heart failure, uncontrolled active infection, history of significant hemorrhage within 4 weeks of the first dose date, intestinal disease or major gastric surgery, arterial thrombosis within 6 months of screening * Certain prior therapies such as: anti-cancer treatment within 2 weeks of Cycle 1 Day 1, prior radiotherapy within 14 days before screening, active anti-coagulation therapy, over the counter or prescription medications within 14 days or 5 half-lives prior to cycle 1 day 1, herbal medicines and supplements within 14 days * Major surgery within 1 month of screening * Hemoglobin \< 9.0 g/dL * Absolute neutrophil count \< 1.5 x 10\^9/L * Platelet count \< 100 x 10\^9/L * Hepatic function: 1. Aspartate aminotransferase and/or alanine aminotransferase (ALT) \>3 × upper limit of normal (ULN) (\>5 x ULN for subjects with liver metastases) 2. Total bilirubin \>1.5 × ULN (except participants with Gilbert's syndrome). 3. Albumin \< 3 g/dL * Calculated or measured creatinine clearance of \<60 mL/minute calculated using the formula of Cockcroft and Gault (\[140 - Age\] × Mass \[kg\] / \[72 × serum creatinine mg/dL\]). Multiply result by 0.85 if female. * Fridericia's corrected QT interval (QTcF) \>470 msec or a family history of Long QT Syndrome. * Cardiac function: Echocardiogram (or MUGA) showing Left Ventricular Ejection Fraction (LVEF) \<45% at rest * Infectious diseases: positive for HIV (unless controlled with active retroviral therapy), hepatitis B and hepatitis C

Inclusion Criteria: * Between ages 6-17 * Asthma diagnosis within the last 2 years * Fractional excretion of exhaled nitric oxide (FeNO) \> 50 ppb OR a clinical history of environmental allergies as defined by a positive skin prick or positive specific immunoglobulin E (IgE) tests to aeroallergens * No emergency department visits in the past 1 month * Ability to consume a liquid drink of fiber or placebo * Ability to return for a 4-6 week follow-up visit * No special or unique diet Exclusion Criteria: * Cystic fibrosis * Bronchiectasis * Change in asthma medicines other than short acting bronchodilators planned over the next 4-6 weeks * Baseline estimated daily fiber intake less than or equal to 16 grams as determined by the ASA 24 * Sibling of a participant already enrolled in the study

Inclusion Criteria: * Attendance in kindergarten Exclusion Criteria: * Use of antibiotics in the year before sampling

Inclusion Criteria: * Aged 18 years or older * Have a clinician-confirmed diagnosis within the past 12 months of first-time breast and/or gynecologic cancer (e.g., cervical, ovarian, uterine, vaginal, vulvar) in stages I-III * Currently or will receive treatment with curative intent * Score less than 8 on the National Comprehensive Cancer Network (NCCN) Distress Thermometer, indicating low to moderate levels of distress * Score less than 15 on the Patient Health Questionnaire-9 items (PHQ-9, indicating low to moderate levels of depression Exclusion Criteria: * Selected '2 Several days' or '3 Almost everyday' on PHQ9 item #9, indicating indicating imminent risk of suicide * Have severe chronic diseases (e.g., coronary heart disease, chronic obstructive pulmonary disease (COPD), chronic renal failure), at the discretion of the treating clinician or study investigator * People with a risk for psychosis, mania, and alcohol abuse, based on screening questions commonly used in the field * Cannot attend the intervention activities at the hospital during the proposed intervention period

Inclusion Criteria: * type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes * HbA1c ≥7.0%, stable medication use * HbA1c 6.0-6.9% without short-acting insulin, any other stable diabetes medication use * English-speaking (app in English) Exclusion Criteria: * Current pregnancy * Hydroxyurea use (CGM sensor inaccuracies) * Cognitive impairment or severe psychiatric condition that could interfere with participation in behavioral intervention for diabetes self-management * Current or previously diagnosed eating disorder

In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Age 18-65 years * Body Mass Index 25-45 kg/m2 * Diagnosis of stage 1-3 breast cancer within the past 10 years with completion of standard of care definitive surgery, adjuvant chemotherapy, radiation, immunotherapy and/or targeted therapy as appropriate prior to the intervention start date. Completion of definitive surgery must be ≥ 3 months prior to the intervention start date, other therapies must be completed ≥ 1 month prior to the intervention start date (however exceptions to this 1-month timeframe for completion of other therapies can be made on a case-by-case basis by the PI if patients are tolerating therapy without adverse effects and will have completed treatment prior to the intervention start date). Current/ongoing use of anti-endocrine directed therapy for breast cancer (including ovarian suppression, tamoxifen, aromatase inhibitors, selective estrogen degraders) is acceptable as long as participants have been on therapy for ≥3 months prior to the intervention start date. * Live or work within 30 miles of the AHWC (exceptions may be made at the discretion of the Study PI on a case-by-case basis for highly motivated subjects). * Capable and willing to give informed consent and understand exclusion criteria, willing to attend weekly small group sessions held by a registered dietitian, and attend one in person BfitBwell exercise sessions per week. * Have a primary care provider (PCP) (or are willing to establish care with a PCP prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions. * Obtain a signed medical clearance from their medical provider for participation in the 4:3 IMF dietary intervention and BfitBwell clinical exercise oncology program. * Own or willing to purchase a smart phone or computer to join Zoom meetings, complete questionnaires, and access/download the True Coach virtual exercise coaching sessions. All interested individuals will complete a brief online eligibility screener through REDCap to confirm initial eligibility. Exclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or higher. * Actively undergoing chemotherapy, radiation, immunotherapy and/or targeted therapy (other than anti-endocrine therapy) or are within 1 month of completion of chemotherapy, radiation, immunotherapy and/or targeted therapy (other than anti-endocrine therapy) as of the target intervention start date. Exceptions to this 1-month timeframe can be made on a case-by-case basis at the discretion of the PI if patients are tolerating therapy without adverse effects and will have completed treatment prior to the intervention start date. * Plans to relocate within the next 12 months. * Plans for extended travel (\>2 weeks) within the next 12 months. * Major surgery within the past 3 months (including mastectomy or breast reconstruction but not including lumpectomy or other minor surgeries) or planned major surgery (including mastectomy or breast reconstruction) during the timeframe of the 6 month study intervention and follow-up phases. * For Females: * Currently pregnant or lactating. * Pregnant within the past 6 months. * Planning to become pregnant in the next 12 months; sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use a reliable means of contraception. * Recent (past 6 months) acute coronary event, unstable angina, coronary revascularization, stroke, pulmonary embolism, or hospitalization for heart failure or cardiac arrythmia. * Symptoms suggestive of cardiovascular disease or unstable angina (e.g., chest pain, shortness of breath at rest or with mild exertion, lightheadedness, syncope). * Uncontrolled hypertension, defined as diastolic blood pressure \>100 mmHG, systolic blood pressure \>160 mmHG, or resting heart rate \>100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position. * Diabetes (history of type 1 or type 2 diabetes or fasting glucose ≥126 mg/dL or Hemoglobin A1C ≥6.5% as measured on screening labs) unless on metformin or on dipeptidyl peptidase IV (DPP-IV) inhibitor monotherapy and well-controlled with Hemoglobin A1C \<8%. * Undiagnosed hypo- or hyper-thyroidism (TSH outside of the normal range as measured on screening labs) or history of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen is acceptable. * Stage 4 or 5 chronic kidney disease as assessed by estimated glomerular filtration rate \<30 as measured on screening labs. * Triglycerides \>500 mg/dL or LDL cholesterol \>200 mg/dL as measured on screening labs. * Serious arrhythmias, including multifocal PVC's, frequent PVC's (defined as 10 or more per min), ventricular tachycardia (defined as runs of 3 or more successive PVC's), or sustained atrial tachyarrhythmia; 2nd or 3rd degree A-V block, known QTc interval \> 480 msec or other significant conduction defects. * Clinically significant abnormalities in hematocrit/hemoglobin, white blood cell count, platelets, serum sodium, potassium, or bicarbonate as measured on screening labs or presence or history of other metabolic or chronic health problems which would impact ability to safely participate in a weight loss intervention involving an intermittent energy restricted diet and exercise including significant cardiac valvular disease or heart failure, significant gastrointestinal, pulmonary, renal, musculoskeletal, neurologic, hematologic, orthopedic, or psychiatric disease. * Sustained use of prescription or over-the-counter medications known to significantly impact appetite, weight, or energy metabolism (e.g., anti-obesity pharmacotherapy, appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants) with the exception of anti-endocrine directed treatment for breast cancer and standard of care anti-emetic or anti-diarrheal agents. * Sustained use of systemic glucocorticoids (current or in the past 6 months) unless physiologic replacement therapy for adrenal insufficiency. * Previous obesity treatment with metabolic bariatric surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed \> 1 year before screening, (2) lap banding if the band has been removed \> 1 year before screening, (3) intragastric balloon if the balloon has been removed \> 1 year before screening (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \> 1 year before screening or 5) AspireAssist or other endoscopically placed weight loss device if the device has been removed \> 1 year before screening. * Nicotine use (current or past 6 months) * Current alcohol or substance abuse. * History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score \>20 on the Eating Attitudes Test (EATS-26) or pattern of response on the Questionnaire of Eating and Weight Patterns (QEWP-5) suggestive of possible binge eating disorder or bulimia will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study. * Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode or history of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study PI would interfere with ability to participate in the diet and exercise interventions and provide feedback on the interventions via questionnaires and focus groups. * Currently participating in or planning to participate in any formal weight loss or physical activity programs or clinical trials over the next 12 months. * Previous participation (within the past 3 years) in the Anschutz Health and Wellness Center (AHWC) BfitBwell Onc

Inclusion Criteria: 1. Voluntarily sign the informed consent and follow the requirements of the protocol; 2. No gender limit; 3. Age ≥18 years old and ≤75 years old; 4. Expected survival time ≥3 months; 5. Patients with unresectable, locally advanced or metastatic triple-negative breast cancer; 6. Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years; 7. The subjects had received 1-2 lines of chemotherapy regimens in the locally advanced or metastatic stage, and had been treated with taxanes previously; 8. Acceptability of chemotherapy with eribulin, capecitabine, gemcitabine, or vinorelbine, as assessed by the investigator; 9. Patients with baseline brain metastases should have received treatment for all brain metastases and be stable; 10. Must have at least one measurable lesion that meets the RECIST v1.1 definition; 11. ECOG score 0 or 1; 12. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0; 13. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 14. No blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before the first use of the study drug, and the organ function level must meet the requirements; 15. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5×ULN; 16. Urine protein ≤2+ or \< 1000mg/24h; 17. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: 1. Prior receipt of an ADC with a TOPI inhibitor as a toxin; 2. Prior receipt of an ADC or antibody drug targeting EGFR and/or HER3; 3. Chemotherapy, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives before the first dose, small molecule targeted therapy within 5 days, palliative radiotherapy and anti-tumor therapy within 2 weeks; 4. Anthracycline equivalent cumulative dose of adriamycin \> 360 mg/m2; 5. History of severe cardiovascular or cerebrovascular disease; 6. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 7. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia; 8. Active malignancy diagnosed within 5 years before randomization; 9. Hypertension poorly controlled by two antihypertensive drugs; 10. Patients with poor blood glucose control before the first dose; 11. A history of interstitial lung disease requiring steroid therapy, or current radiation pneumonitis, or a suspicion of such disease; 12. Complicated with pulmonary diseases leading to clinically severe respiratory impairment; 13. Patients with carcinomatous meningitis (meningeal metastasis) or brain stem metastasis or spinal cord compression; 14. Have a history of allergy to recombinant humanized antibodies or any of the ingredients of BL-B01D1; 15. A history of autologous or allogeneic stem cell transplantation; 16. Human immunodeficiency virus antibody positive, active hepatitis B virus infection, or hepatitis C virus infection; 17. Severe infection within 4 weeks before randomization; Evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization; 18. Patients with massive or symptomatic effusions or poorly controlled effusions; 19. Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx; 20. Were receiving long-term systemic corticosteroids or equivalent active anti-inflammatory drugs or any form of immunosuppressive therapy before randomization; 21. Received other unmarketed investigational drug or treatment within 4 weeks before the first dose; 22. Patients with superior vena cava syndrome should not be rehydrated; 23. A history of severe neurological or mental illness; 24. Severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent; 25. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 26. History of intestinal obstruction, inflammatory bowel disease, or extensive bowel resection or presence of Crohn's disease, ulcerative colitis, or chronic diarrhea; 27. Patients scheduled for vaccination or receiving live vaccine within 28 days before the first dose; 28. Other circumstances that were assessed by the investigator as inappropriate for participation in the trial.

Inclusion Criteria: * Adults with diabetes aged 19 and older * Individuals with a carotid ultrasound cIMT (carotid intima-media thickness) of 1.0mm or more * Those who have not changed their combination therapy medications (including oral hypoglycemics, antihypertensives, and lipid-lowering drugs) in the last three months * Individuals with an HbA1c level of 10% or less * Those who have voluntarily signed the written consent form and agreed to participate in the study Exclusion Criteria: * Individuals currently using antithrombotic or anticoagulant medications other than aspirin * Individuals with bleeding or conditions that may increase the risk of bleeding, such as: * Hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal bleeding, urinary bleeding, hemoptysis, vitreous hemorrhage, etc * Active peptic ulcer, hemorrhagic stroke within the last 6 months, surgical operations within the last 3 months, proliferative diabetic retinopathy, uncontrolled hypertension * Patients who have had cerebrovascular or cardiovascular complications within the past 6 months (including stroke, transient ischemic attacks, myocardial infarction, unstable angina, coronary artery bypass graft, or percutaneous coronary intervention) * Patients with severe renal or hepatic diseases * Patients with congestive heart failure * Individuals with a history of hypersensitivity to the drug or its components * Pregnant women or women who may be pregnant * Women who are breastfeeding or plan to breastfeed during the study

Inclusion Criteria: * age 18-65 years at screening; * Body mass index ≥30 or ≤50kg/m2; * If subject has Type 2 Diabetes: fasting plasma glucose greater than 6,1 mmol/l at time of enrollment if not treated with anti-diabetic medication; * If on no diabetes medications, Hemoglobin A1C between and including 6.5 and 9.0 at time of enrollment. Exclusion Criteria: * Body Mass Index \>50 or \<30 kg/m2; * Diagnosis of Type 2 diabetes less than 6 months; * History of suspected gastrointestinal disease (for example cirrhosis, inflammatory bowel disease); * History of active malignancy (not in remission) with the exception of squamous or basal cell carcinoma of the skin; * Ongoing systemic infection; * Chronic pancreatitis; * Chronic liver disease of any cause; * Poorly controlled psychiatric disease (for example ongoing major depression, schizophrenia, borderline personality, suicidality, psychosis); * Any history of an eating disorder within the past 5 years; * Pre-existing severe comorbid cardio-respiratory disease (for example congestive heart failure, cardiac arrhythmia, coronary artery disease, chronic obstructive lung disease, pulmonary embolism); * uncontrolled hypertension (systolic Blood Preassure \> 150 mm Hg or diastolic Blood Preassure \> 100 mm Hg).

While in the ED, the patient must meet all of the following: * Adult (≥18 y/o) * At least one BP with Systolic BP ≥160 or a Diastolic BP ≥100 (criteria 1) * If the patient has repeated measurements after achieving Criteria 1, at least one of the repeat BP remains systolic BP ≥140 or a diastolic BP ≥90 * Must have cell phones with text-messaging capability * Likely to be discharged from the ED Exclusion Criteria for Main Trial Participants: * Critical illness * Unable to read English (\<1% at study site) * Incarcerated * Pregnant * Pre-existing condition making 6-month follow-up unlikely

Inclusion Criteria: * Prediabetes (fasting blood sugar 100-125 mg/dl) * Diabetes type 2 (fasting blood sugar \&gt;126 mg/dl) * Overweight and obesity (BMI 25-50 kg/m2) Exclusion Criteria: * Other diabetes types * Insulin treatment * Shift work * Weight changes \&gt;5% within past 3 months * Systemic glucocorticoid therapy * Systemic infections * Severe anemia * High blood pressure (\&gt;180/110 mmHg) * Endocrinologic, liver and heart disorders * Immune diseases * Thyroid dysfunction * Heart attack or stroke * Cancer in the last 2 years * Eating disorders, food intolerance/allergy, addiction disorders, digestive disorders intestinal, liver, cardiovascular diseases * Hereditary or acquired coagulation disorders * Non-interruptible intake of blood thinners (anticoagulants) * Specific diets, intermittent fasting * Pregnancy or breastfeeding * Severe internal or psychiatric disorders or other conditions and drugs therapy that might influence the outcome of the study

Inclusion Criteria: * Stated willingness to comply with all study procedures and availability for the duration of the study. * Stable asthma medications: No change in asthma medications for the past 2 months: 1. Use of medium or high dose inhaled corticosteroids (ICS) AND 2. Use of an additional asthma controller medication. * Baseline poor or uncontrolled asthma. * Evidence of asthma demonstrated by either bronchodilator reversibility (either at screening or by historical evidence) or methacholine responsiveness (by historical evidence). * Agreement to adhere to Lifestyle Considerations throughout study duration. Exclusion Criteria: * Current participation in an interventional trial (e.g. drugs, diets, etc.). * Currently on an asthma biologic or having been on biologic within 3 months of screening. * Enrollment in a clinical trial where the study medication was administered within the past 60 days or within 5 half-lives (whichever is greater). * Physician diagnosis of other chronic pulmonary disorders associated with asthma-like symptoms, including, but not limited to, cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways. * Receiving one or more immune-modulating therapies for diseases other than asthma. This includes biologics that are also approved for asthma. * Receiving methotrexate, mycophenolate (CellCept®), or azathioprine (Imuran®). * Receiving aero allergen immunotherapy and not on at least 3 months of maintenance allergen immunotherapy. * Underwent a bronchial thermoplasty within the last two years. * Born before 30 weeks of gestation. * Uncontrolled hypertension, defined as systolic blood pressure \> 160 mm/Hg or diastolic blood pressure \> 100 mm/Hg. * History of malignancy except non-melanoma skin cancer within the last five years. * History of smoking: 1. If \<45 years old: Smoked for ≥5 pack-years\* 2. If ≥45 years old: Smoked ≥ 10 pack years. * Active use of any inhalant \>1 time per month in the past year. * Substance abuse within the last year. * Unwillingness to practice medically acceptable birth control or complete abstinence during the study, current pregnancy, or lactation. * Requirement for daily systemic corticosteroids at the time of screening. * Respiratory infection within 1 month of screening. * Intubation for asthma in the last 12 months. * Any clinically significant abnormal findings in the history, physical examination, vital signs, electrocardiogram, hematology or clinical chemistry during run-in period, which in the opinion of the site investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study. * BMI \> 38. * Allergic to any of the drugs, biologics or chemicals used in this study.

Inclusion Criteria: * English- or Spanish-speaking * maternal age \>18 years old * smartphone ownership * receiving prenatal care from a resident or nurse-practitioner/midwifery clinic at the Obstetric and Gynecologic Care Center at WIH * plan to receive postpartum care at the OGCC, * gestational age ≥32 weeks'. Exclusion Criteria: * Active diagnosis or history within five years of depression, anxiety, or other psychiatric condition, as documented in the electronic medical record * Endorsing active suicidality on intake survey or screening positive on EPDS (≥10) or Patient Health Questionnaire (PHQ)-9 (≥10) or GAD-7 (≥8) * prisoners * inability to consent.

Inclusion Criteria: 1. Postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post- menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Any of the following criteria must be met: 1. Recent (within 12 months from date of consent form signature) histologic diagnosis of ER+ve (\>5%) DCIS (patients with DCIS should have undergone breast-conserving therapy i.e. lumpectomy to remove the tumor with negative surgical margins followed by radiotherapy) or diagnosis within 3 years of HRL (ADH, LCIS, ALH), or: 2. At least 3% breast cancer risk at 5 years (or 5% risk at 10yrs) per one of the following risk models: the Breast Cancer Surveillance Consortium risk calculator V3 or Tyrer-Cuzick model V8 or: 3. Known carriers of a germline pathogenic/likely pathogenetic variant in the following moderate penetrance genes (CHEK2 or ATM), or women with chest wall irradiation before age of 30 years. 2. Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) 0-1. 3. Able to swallow oral medications. 4. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Specifically, all cancers diagnosed since 3 years or longer except for breast and endometrial are eligible. 5. Ability to understand and the willingness to sign a written informed consent document. 6. Mammography performed up to 6 months before the trial consent form signature. 7. DEXA performed up to 12 months before the trial consent form signature. 8. Patients with life expectancy ≥ 10 years. 9. Patients with normal liver function tests and blood cell count. 10. Negative gynaecological examination performed up to 6 months before the trial consent form signature. Exclusion Criteria: 1. Pre/perimenopausal women 2. History of DVT or PE. 3. Endometrial cancer. 4. Macular disorders. 5. Inability to comply with study procedures. 6. Prior use of antiestrogens within 12 months from the date of the trial consent form signature. 7. Use of hormone replacement therapy (HRT) within 3 months from the date of the trial consent form signature. 8. Severe osteoporosis (T score ≤ 2.5 at either spine or hip), or recent vertebral fracture (within 6 months) not treated with zolendronic acid or denosumab. 9. Use of terbinafine, quinidine, cinacalcet, rifampicin, phenytonin, carbamazepine, phenobarbital, and St. John's wort, warfarin, erythromycin, cyclosporin, nifepidine and any concomitant coumarin-type anticoagulant therapy. 10. Patients with moderate or severe renal impairment. 11. Patients with a known hypersensitivity to study drugs.

Inclusion Criteria: * Pre- or post-menopausal HR+ metastatic breast cancer patients who are: * Group 1: scheduled to initiate 1st line combination therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ metastatic breast cancer (mBC). * Group 2: scheduled to initiate second or later lines of therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) with or without an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC. * Group 3: currently receiving 1st line therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC. * Group 4: scheduled to initiate, or are currently receiving, 1st or 2nd line therapy of an FDA approved endocrine therapy (single agent) for pre- or post-menopausal HR+ mBC. * Group 5: scheduled to initiate or are currently receiving 1st line therapy of an FDA-approved CDK4/6 inhibitor (ribociclib or abemaciclib) with an FDA approved endocrine therapy for stage 2 or stage 3 adjuvant HR+ BC NOTE: Patients that meet eligibility criteria for any of the above groups that are already enrolled in an ongoing clinical trial are eligible for co-enrollment to this observational study. Exclusion Criteria: * Treatment including investigational agent or therapies * Early breast cancer diagnosis * Male breast cancer * Currently receiving treatment for other active malignancy at time of registration * EXCEPTIONS: Nonmelanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate) * Inability to give written informed consent

Inclusion Criteria: * Individuals at least 18 years old * Individuals must be symptomatic with respiratory symptoms * Individuals must complete the UCAP-Q questionnaire and score a ≥ 6% probability of having either asthma or COPD. * Individuals who have given written informed consent to participate in this trial in accordance with local regulations; * Individual must be able to perform pre and post bronchodilator spirometry to measure lung function Additional Inclusion Criteria for the Randomized Controlled Trial (RCT): * Individuals who have undiagnosed airflow obstruction on spirometry testing (i.e. Asthma or COPD) will be asked to participate in the RCT. Exclusion Criteria: * Individuals who report a previous diagnosis of asthma, COPD, history of lung cancer, bronchiectasis, interstitial lung disease, cystic fibrosis or other significant diagnosed lung disease. * Individuals currently under the care of a Respirologist. * Individuals currently using inhaled corticosteroids or long-acting bronchodilators. * Individuals with history of myocardial infarction, stroke, aortic or cerebral aneurysm, or detached retina or eye surgery within the past 3 months (spirometry is contraindicated) * Individuals who are in the third trimester of pregnancy * Individuals involved in another interventional trial

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Has a diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2023 guidelines for at least 3 months prior to randomization. 2. Participants who are either: * Currently untreated * Treated with daily maintenance ICS or ICS/LABA 3. ACQ-6 score ≥1.5 at randomization. 4. Participants able to perform technically acceptable and repeatable FEV1 maneuvers (i.e., a minimum of 2 acceptable and 1 repeatable effort) at visit 2 (V2) 5. Participants must be able to complete the study questionnaires. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 1. Recent history of life-threatening asthma 2. History of \>1 severe exacerbation of asthma within 12 months prior to randomization. 3. Women of childbearing potential that are not following at least one highly effective method of contraception. This includes women who are pregnant or lactating or are planning on becoming pregnant during the study. 4. A WOCBP must have a negative pregnancy test ≤7 days prior to randomization. 5. Exposure to inhaler triple therapy \[ICS + Long-acting muscarinic antagonist (LAMA) + LABA as Single inhaler triple therapy (SITT) or Multiple inhaler triple therapy(MITT)\] and/or any LAMA-containing therapy within 12 months prior to randomization. 6. Ongoing need for biologic therapy or recent use of a biologic therapy 7. Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines. 8. Participants whose current medications include RELVAR ELLIPTA and ARNUITY ELLIPTA are not eligible to enter the study. 9. Participants who are medically unable to withhold their albuterol/salbutamol for 6 hours prior to spirometry testing 10. Changes in asthma medication (e.g., maintenance ICS/LABA) within 3 months prior to randomization. 11. Participants with a history of hypersensitivity to any of the study medications

Inclusion Criteria: * Diagnosis of anxiety, depression or substance use disorder. Resident on or near Turtle Mountain or Spirit Lake reservation. Enrolled in federally recognized tribe. Exclusion Criteria: * Literacy below fourth-grade level. Diagnosis of personality disorder or schizophrenia, or other impaired perception of reality.

Inclusion Criteria: 1. Signed informed consent by the parents or the legal representatives and written assent from appropriately aged participants 2. Males or females from birth to under 18 years of age at the time informed consent was signed 3. Confirmed diagnosis of severe PAH classified as PH Group 1 requiring a treatment with prostacyclin infusion 4. Current diagnosis of PAH confirmed by right heart catheterisation (RHC) at screening or by historical RHC prior to screening with following haemodynamic findings: * Mean pulmonary arterial pressure (mPAP) \>20 mmHg * Pulmonary vascular resistance Index (PVRI) \>3 Wood Units (WU) m² If RHC is not possible due to medical reasons (e.g. neonates and infants), the confirmation by ECHO at the screening is sufficient. 5. Prostacyclin naïve or patients pre-treated with SC or IV treprostinil prior to screening 6. A subject is eligible to participate in this study, as assessed by the investigator, if they are of: * Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, * Child-bearing potential - has a negative pregnancy test and is not lactating and, if sexually active, agrees to continue to use 2 reliable methods of contraception until study completion and for at least 30 days following the last dose of study drug. Examples of reliable birth control methods include true abstinence as a lifestyle choice (periodic sexual abstinence method is not acceptable); the use of oral contraceptives; a reliable barrier method of birth control (diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices) Exclusion Criteria: 1. Known intolerance to prostacyclin analogues 2. PH related to conditions other than specified above 3. Unrepaired congenital heart disease if surgery is planned within next 5 months 4. Subjects diagnosed with any lung disease 5. Acutely decompensated heart failure within previous 30 days from screening 6. Subjects who have had an atrial septostomy or potts shunt within the previous 6 months of screening 7. Any clinically significant laboratory abnormality that precludes initiation or continuation of treprostinil therapy 8. Moderate to severe hepatic dysfunction as defined by elevated liver function tests (aspartate aminotransferase or alanine aminotransferase) ≥3 times the upper limit of normal at Screening, or Child Pugh class B or C hepatic disease 9. Subjects who are pregnant or breastfeeding 10. Haematological abnormalities (e.g., severe anaemia, Hgb \<10 g/dL, leukopenia, White Blood Cells (WBC) \<2500/μL) 11. History of substance use disorder, unless a proof of abstinence ≥1 year is provided 12. Other concurrent severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study 13. Participation in another clinical trial of an investigational drug or device (including with placebo) within 30 days or 5 half-lives prior to screening, which-ever is longer 14. Patients not able to handle pumps and infusion site if there is no parent, family member, guardian present in their household taking over pump handling or if they are not treated in hospital set-up

Inclusion Criteria: * Clinical diagnosis of type 2 diabetes and diabetic gastrointestinal motility disorder. * Glycated hemoglobin (HbA1c) \< 11.0%. Exclusion Criteria: * Insulin dependent diabetes; * Active infections, antibiotics-using, inflammatory bowel disease, irritable bowel syndrome, or other severe gastrointestinal organic disease; * Severe diabetic complications; * Thyroid disease, malignancies, severe cognitive impairment and mental disease; * Alcohol or substance abuse; * Pregnancy or lactation.