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Inclusion Criteria: * Adults aged between 18 and 65, having given written informed consent to participate in the research trial. * Currently using a psychiatric medication as prescribed by a healthcare professional for longer than 3 months. * Normal or corrected to normal vision using either glasses or contact lenses, or surgery. Exclusion Criteria: * Enrolled in, or participated in another clinical trial within 30 days before the study * Having a prosthetic eye, missing eye, or wearer of an eye patch LASIK or other eye surgery within the prior 21 days. * Had your eyes dilated by a medical doctor in the previous 24 hours. * Photosensitive epilepsy * Diagnosed with clinical blindness * Medical Conditions: Participants with medical conditions or medications that could significantly affect cognitive and motor functions are excluded. Participants with conditions such as Glaucoma, macular degeneration, cataracts, lazy eye (amblyopia), or optic neuritis, or genetic anisocoria (unequal pupil size) will be excluded. * Current or past head inject/ traumatic brain injury (TBI) * Pregnancy: Pregnant individuals will be excluded from the study due to the potential risks associated with psychiatric medications. * History of Severe Motion Sickness: Participants with a history of severe motion sickness in VR environments may be excluded, as they may not tolerate the VR headset well. * Potential participants who are unable to provide consent for the study.

Inclusion Criteria: Subjects meeting all of the following inclusion criteria will be included in this study: 1. Subjects ≥18 years of age 2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year 3. Subject has signed an informed consent form (ICF) and is willing to comply with protocol requirements Exclusion Criteria: Subjects meeting any of the following exclusion criteria at the time of screening will be excluded from this study: 1. History of severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure. 2. History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months. 3. Subjects with gastroparesis. 4. Female subjects of childbearing capacity (defined as of childbearing age and as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study. 5. A condition preventing or complicating the placement, operation, or removal of the sensor or wearing of transmitter, including upper extremity deformities or skin condition. 6. Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke in the past 6 months; uncontrolled hypertension (systolic\>160 mm Hg or diastolic \>100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with asymptomatic coronary artery disease (e.g., CABG, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented. 7. Hematocrit \<38% or \>60% at screening 8. History of hepatitis B, hepatitis C, or HIV 9. Current treatment for a seizure disorder unless written clearance by neurologist to participate in study. 10. History of adrenal insufficiency 11. Currently receiving (or likely to need during the study period): immunosuppressant therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin); topical glucocorticoids over sensor site only; antibiotic for chronic infection (e.g., osteomyelitis, endocarditis) 12. A condition requiring or likely to require magnetic resonance imaging (MRI) 13. Known topical or local anesthetic allergy 14. Known allergy to glucocorticoids 15. Any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject's best interest to participate in the study. Conditions include but are not limited to psychiatric conditions, known current or recent alcohol abuse or drug abuse by subject history, a condition that may increase the risk of induced hypoglycemia or risk related to repeated blood testing. Investigator will supply rationale for exclusion 16. Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period 17. The presence of any other active implanted device (as defined further in the protocol)

Inclusion Criteria: * Over 18 years of age * PHQ9 or PHQ8 score \>=8 * History of coronary heart disease per EHR search for ICD-9 codes of 410-414 and ICD-10 codes: I20, I21, I22, I23, I24, I25. * Appointment with a primary care provider (PCP) or cardiologist in an integrated care setting in NYP/Columbia (e.g., does not include procedure or lab-only visits) * Has a PCP at NYP/Columbia active on the NYP/Columbia EHR Exclusion Criteria: * Not English or Spanish speaking * History of severe mental illness (bipolar disorder, schizophrenia, chronic/recurrent depression, history of suicide attempt or self-inflicted injuries) * Dementia * Had an integrated mental health visit in the last 3 months as indicated in the EHR * Enrollment in the post-implementation period of IRB# AAAR9175

Inclusion Criteria: Age between 18 and 55 years (inclusive). Clinically significant level of anxiety according to the Beck Anxiety Inventory (BAI) ≥ 9 points. Anxiety subscale score on the Hospital Anxiety and Depression Scale (HADS-A) ≥ 11 points. Significant level of preverbal trauma according to the "Diagnostics of Preverbal Dysregulation" (DPD, T. Pavlenko) questionnaire: total score ≥ 16. Specific subscale scores in DPD: "Desire" ≥ 5, "Satisfaction" ≥ 5, and "Possession" (Obsession) ≥ 6 points. Presence of internal conflicts according to the "Internal Conflict Test" (ICT) ≥ 1 point on the skin tissue measurement scale. Willingness to comply with the study protocol and the online therapy format. Exclusion Criteria: Current participation in any other psychotherapy during the study. Use of any psychotropic medications within the last 30 days (antidepressants, tranquilizers, neuroleptics, mood stabilizers). Diagnosed severe mental disorders (according to ICD-10/DSM-5) requiring specialized psychiatric care or inpatient treatment. Presence of acute suicidal risk. Substance abuse (alcoholism, drug addiction). Failure to meet any of the threshold values specified in the inclusion criteria.

Inclusion Criteria * Adults aged 18 years or older. * Confirmed diagnosis of pulmonary arterial hypertension (Group 1). * Treatment with triple therapy including an endothelin receptor antagonist, a prostacyclin pathway agent, and a phosphodiesterase-5 inhibitor for at least 12 weeks. * Switch from a phosphodiesterase-5 inhibitor to riociguat as part of routine clinical care. * Availability of minimum data to assess the primary outcome at 6 months. Exclusion Criteria * Concomitant use of phosphodiesterase-5 inhibitors and riociguat. * Inability to confirm vital status or hospitalization outcomes within 6 months. * Participation in an interventional clinical trial that mandated the treatment switch.

Inclusion Criteria: * History of breast cancer surgery (mastectomy or breast-conserving surgery), with or without axillary lymph node dissection * Persistent ipsilateral chest wall and/or axillary pain, tightness, or movement restriction lasting ≥ 3 months after surgery; * Clinically significant baseline symptom severity, defined as Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire ≥ 25 and/or pain intensity ≥ 5/10 on the Numeric Rating Scale (NRS); * Completion of 12 weeks of standard physical therapy with no significant improvement, defined as a change in QuickDASH score from baseline to completion of therapy below the minimal clinically important difference (MCID; \<15 points ) and/or pain improvement \< 2 points on the NRS . * Age ≥ 18 years; * Ability to provide written informed consent. Exclusion Criteria: * Evidence of local cancer recurrence or metastatic disease; * Active lymphedema requiring ongoing decongestive therapy at the time of enrollment; * Shoulder pathology, including intra-articular or peri-articular conditions (e.g., adhesive capsulitis with marked capsular restriction, or acute rotator cuff tear,) judged by clinical assessment to be the dominant cause of symptoms. * Active infection, skin lesion, or unhealed surgical wound at the intended injection site; * Known bleeding disorders or anticoagulant use contraindicating injection; * Known allergy to dextrose or any components of the injection protocol; * Pregnancy or other medical conditions precluding participation.

Inclusion Criteria: 1. Age ≥ 18 years. 2. Scheduled to undergo elective breast cancer resection surgery. 3. American Society of Anesthesiologists (ASA) physical status classification of I-III. 4. Clearly understand and voluntarily agree to participate in the study, and sign the informed consent form. 5. Female patients with mild to severe depressive symptoms (defined as a Hospital Anxiety and Depression Scale-Depression subscale score of ≥8) 6. Anticipated anesthesia duration greater than 90 minutes. Exclusion Criteria: 1. Patients with significant preoperative abnormalities in cardiac, pulmonary, hepatic, or renal function, or coagulation disorders . 2. Patients taking antipsychotics, antidepressants, or glucocorticoids, or with a history of alcohol abuse or illicit drug use . 3. Patients with an MMSE score \<18, dementia, intellectual disability, or those unable to communicate (e.g., coma, severe dementia, hearing or language impairment) . 4. Patients with a history of psychiatric or neurological disorders (e.g., schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis) . 5. Patients with poorly controlled or untreated hypertension (≥180/110 mmHg) . 6. Patients with elevated intracranial or intraocular pressure. 7. Patients with untreated or inadequately treated hyperthyroidism . 8. Patients with a known allergy to the drugs involved in this study . 9. Patients unable to complete the assessment scales required by this study. 10. Patients who are currently participating in other clinical trials

INCLUSION CRITERIA: * At targeted community pharmacy for: * New prescription or change in dose/schedule of SSRI (citalopram, escitalopram, sertraline, paroxetine), OR * Concurrent SSRI (citalopram, escitalopram, sertraline, paroxetine) and new prescription/change in SNRI (desvenlafaxine, duloxetine, and venlafaxine) / bupropion. * Depressive symptoms confirmed by PHQ8 assessment (\>5 indicating at least mild depressive symptoms) * UPMC patient (or able/willing to become one) and has UPMC provider (or able/willing to obtain one) * Signed consent to join Pitt+Me Discovery biobanking research study. * English-speaking EXCLUSION CRITERIA: * Inability to receive CMM at specific pharmacy/pharmacist * Comorbid diagnosis of schizophrenia (patient-reported) * Untreated sleep disorder (patient-reported) * Pitt+Me Discovery participant who has elected to not receive return of results, or who has already received results previously

Inclusion Criteria: 1. Aged 18 years or older. 2. Willing to participate in the study and able to provide written informed consent. 3. Diagnosed with at least one of the following "Four Highs" conditions: Hypertension: Diagnosed primary hypertension, defined as seated office SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg on at least three non-consecutive days, or currently taking antihypertensive medication. Blood pressure must be controlled while on four or more antihypertensive agents. Diabetes Mellitus: Diagnosed diabetes, defined as having typical symptoms plus random plasma glucose ≥ 11.1 mmol/L, or fasting plasma glucose ≥ 7.0 mmol/L, or 2-hour plasma glucose during OGTT ≥ 11.1 mmol/L, or HbA1c ≥ 6.5%, or currently taking glucose-lowering medication. HbA1c level must be between 6.5% and 13.0%. Hyperlipidemia: Diagnosed hyperlipidemia, defined as total cholesterol (TC) ≥ 6.22 mmol/L, or LDL-C ≥ 4.14 mmol/L, or HDL-C \< 1.04 mmol/ L, or triglycerides (TG) \> 2.26 mmol/L, or currently taking lipid-lowering medication. Hyperuricemia: Diagnosed hyperuricemia, defined as a fasting serum uric acid level \> 420 μmol/L (7 mg/dL) in men and postmenopausal women, or \> 360 μmol/L (6 mg/dL) in premenopausal women, on two non-consecutive days under a normal purine diet, or currently taking urate-lowering medication. 4. Capable of using a smartphone. 5. A local permanent resident who receives basic public health service management at the designated community health center/station or township hospital. 6. Has not engaged in regular moderate- to vigorous-intensity physical activity (defined as at least 30 minutes per session, on at least 3 days per week) in the past three months. Exclusion Criteria: Patients meeting any of the following criteria will be excluded: 1. History or acute episode of cardiovascular or cerebrovascular disease, including: angina pectoris, myocardial infarction, coronary revascularization surgery, stroke (ischemic or hemorrhagic, including transient ischemic attack), symptomatic peripheral arterial disease requiring surgery or diagnosed by vascular imaging, ventricular arrhythmia, uncontrolled atrial fibrillation, congestive heart failure (New York Heart Association Class III or IV), hypertrophic cardiomyopathy, history of aneurysm with diameter ≥ 5.5 cm or prior aneurysm surgery. 2. Current malignant tumor or history of malignant tumor within the past five years. 3. Contraindications to exercise, such as bone and joint diseases. 4. Severe respiratory diseases, including asthma, chronic obstructive pulmonary disease (COPD), restricted lung volume (due to obesity, pregnancy, or spinal deformity), or cystic fibrosis. 5. Neuromuscular and degenerative diseases, such as muscular dystrophy, poliomyelitis, and dementia. 6. Severe mental illness, including schizophrenia, bipolar disorder, eating disorders, or depression (with hospitalization for the condition within the past 6 months). 7. Movement and other neurological disorders, such as Huntington's disease, torsion dystonia, Parkinson's disease, and certain epileptic disorders. 8. Severe comorbidities with a life expectancy of less than 24 months. 9. Plans to relocate from the area within the next three months. 10. Participation in other physical activity level intervention programs within the six months prior to the screening visit. 11. Current participation in another randomized clinical trial. 12. Any other condition that, in the investigator's judgment, may interfere with adherence to the trial protocol.

Inclusion Criteria: * Age 18 years or older Exclusion Criteria: * Inability to perform spirometry

Inclusion Criteria: * Male or female participants aged ≥18 years at the time of randomization. * Clinical diagnosis of plaque psoriasis with Psoriasis Area and Severity Index (PASI) ≥3 and body surface area (BSA) ≥3%. * Body mass index (BMI) ≥25 kg/m², consistent with overweight or obesity. * Participants with or without type 2 diabetes mellitus. * Participants with diabetes must be on stable antidiabetic therapy (no changes in medication or dosage within the previous 3 months) and have adequate glycemic control, defined as HbA1c ≤9.0% at baseline. * No use of systemic psoriasis therapies (e.g., methotrexate, cyclosporine) for at least 8 weeks prior to randomization. * No use of biologic therapies for at least 3 months prior to randomization. Exclusion Criteria: * Diagnosis of a non-plaque psoriasis subtype, including pustular, guttate, nail, inverse, psoriatic arthritis, or erythrodermic psoriasis. * Pregnancy or breastfeeding at the time of screening or enrollment. * Insulin-dependent diabetes mellitus or current use of sulfonylureas. * Active malignancy at the time of screening. * History of thyroid neoplasia. * Presence of autoimmune diseases. * Use of systemic therapies within 8 weeks prior to randomization. * Use of biologic therapies within 3 months prior to randomization. * Renal insufficiency. * Heart failure. * Hepatic insufficiency. * History of pancreatitis. * Current treatment with other GLP-1 receptor agonists. * History of inflammatory bowel disease. * Known allergy to starch.

Inclusion Criteria: * Age and Gender: Female patients aged ≥18 years and ≤70 years. Histological Confirmation: Patients must have histologically confirmed invasive breast cancer and must not have received any prior systemic anti-tumor therapy for breast cancer. * HER2 Positivity: Histologically confirmed HER2 receptor positivity, following the 2018 ASCO-CAP HER2 positivity judgment guidelines. Confirmed by pathology laboratory with immunohistochemistry (IHC) score of 3+, or 2+ with positive in situ hybridization (ISH) test (ISH amplification rate ≥2.0). * Tumor Stage: Patients must have tumor staging conforming to the Stage II-III breast cancer criteria according to the eighth edition of the AJCC breast cancer TNM staging system (T1\~T4, N1\~N3, M0). * Measurable Target Lesion: At least one measurable target lesion according to RECIST V1.1. * ECOG Performance Status: ECOG functional status score of 0\~1. * Organ Function: Adequate organ function levels, with the following requirements (no blood transfusion or use of leukocyte or platelet elevation drugs within 2 weeks prior to screening): * Hematology: Absolute neutrophil count (ANC) \> 1.5 × 109/L; Platelet count (PLT) \> 75 × 109/L; Hemoglobin (Hb) \> 90 g/L. * Blood Chemistry: Total bilirubin (TBIL) \< 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 1.5 × ULN; Alkaline phosphatase \< 2.5 × ULN; Blood urea nitrogen/urea (BUN/UREA) and creatinine (Cr) \< 1.5 × ULN. * Cardiac Ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%. * 12-Lead ECG: Fridericia's method corrected QT interval (QTcF) \< 470 msec. * Reproductive Status: For premenopausal women with potential fertility, a pregnancy test must be performed within 7 days before treatment initiation, with negative serum/urine pregnancy results. * Patients must not be lactating and must use adequate barrier contraception throughout the treatment cycle and for 6 months after treatment completion. Voluntary Participation: Voluntary participation in the study with signed informed consent, good compliance, and willingness to cooperate with visit schedules and research-related procedures. Exclusion Criteria: * Stage IV Breast Cancer: Patients with Stage IV breast cancer. Inflammatory Breast Cancer: Patients with inflammatory breast cancer. Prior Malignancy Treatment: Patients who have received prior anti-tumor therapy or radiotherapy for any malignancy, or have concurrent other malignancies, excluding cured cervical intraepithelial neoplasia, basal cell carcinoma, or squamous cell carcinoma. * Concurrent Anti-Tumor Therapy: Patients currently participating in other clinical trials involving anti-tumor therapy, including but not limited to chemotherapy, endocrine therapy, biological therapy, bone modification therapy, or immune checkpoint inhibitor therapy. * Recent Surgery: Patients who have undergone major surgery unrelated to breast cancer within 4 weeks prior to the first dose of the study drug, or have not fully recovered from such surgery. * Serious Cardiac Disease: Patients with serious cardiac conditions, including but not limited to: * History of heart failure or systolic dysfunction (LVEF \< 50%). Uncontrolled high-risk arrhythmia, such as atrial tachycardia, resting heart rate \> 100 bpm, significant ventricular arrhythmia, or advanced atrioventricular block (i.e., Mobitz II second-degree or third-degree atrioventricular block). * Angina pectoris requiring medication. * Clinically significant heart valve disease. * ECG showing transmural myocardial infarction. * Uncontrolled hypertension (after medication, systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg). * Uncontrolled Active Infection: Patients with uncontrolled active infection requiring treatment, or with a history of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. * Allergy to Study Drugs: Patients with a known history of allergy to any component of the study drugs. * Pregnant or Lactating Women: Pregnant or lactating women, women of childbearing potential with positive baseline pregnancy test, or those unwilling to use effective contraception during the trial period and for 6 months after the last dose of the study drug. * Interstitial Lung Disease: Patients with known or suspected interstitial lung disease; those with other severe pulmonary diseases that may interfere with drug-related pulmonary toxicity detection or management within 3 months prior to the first dose, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/obliterative bronchiolitis, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive/obstructive lung disease, or any pulmonary autoimmune or inflammatory disease such as rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis; or those with a history of total pneumonectomy. * Severe Concomitant Diseases: Patients with severe concomitant diseases or other conditions that may interfere with the planned treatment, or those deemed unsuitable for the study by the investigator for any other reason.

Inclusion Criteria: * Experience mild to moderate psychological symptoms or problems related to economy * 18 years or older * Ability to speak, read and write in Swedish * Have access to the internet and a smartphone, computer or other device Exclusion Criteria: * Severe psychiatric or somatic illness that makes participation harder or impossible * Ongoing addiction * Acute suicidality * Other ongoing psychological treatment * Recent (within the latest month) changes in the dose of psychotropic medication or planned change of dose during the treatment weeks

Inclusion Criteria: * Age between 50 and 60 years. Both sexes were included Patients had been diagnosed with hypertension for at least 5 years. Patients had resistant hypertension according to (Whelton et al 2018), defined as: * Systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP) ≥90 mmHg despite the use of three or more antihypertensive medications of different classes, including a diuretic, * or controlled blood pressure (\<140/90 mmHg) while on four or more antihypertensive medications. Body Mass Index (BMI) 25: 34.9 kg/m² Increased waist circumference, defined as: * Greater than 102 cm for males. * Greater than 88 cm for females. Exclusion Criteria: * Secondary hypertension due to identifiable causes (e.g., renal artery stenosis, primary aldosteronism, pheochromocytoma). * History of major cardiovascular events in the last 6 months (e.g., myocardial infarction, stroke, or heart failure exacerbation). * Severe musculoskeletal or neurological disorders that impair the ability to perform isometric exercise safely (e.g., recent joint replacement, severe osteoarthritis, stroke with residual motor deficit). * Contraindications to the use of Transcutaneous Electrical Nerve Stimulation (TENS): Implanted electronic devices: pacemakers, cardioverter defibrillators. Uncontrolled arrhythmias. Sever skin condition: open wounds, rashes, burns, eczema. Peripheral neuropathy or sensory loss. -Known cognitive impairment or psychiatric conditions that would limit the ability to follow instructions or provide informed consent.

Inclusion Criteria: * patients with primary hyperparathyroidism candidate to surgery * age\>/=18 years Exclusion Criteria: age\< 18 years patients with renal insufficiency (CKDEpi \<60ml/mn) pregant women \-

Inclusion Criteria: 1. Female patients aged 18 to 70 years. 2. Unilateral breast cancer confirmed by preoperative pathology. 3. Scheduled to undergo nipple-sparing mastectomy (NSM) with immediate prepectoral implant-based breast reconstruction. 4. Invasive carcinoma with a maximum tumor diameter ≤ 5 cm, or ductal carcinoma in situ (DCIS). 5. Preoperative imaging assessment confirms a distance of ≥ 1 cm between the lesion and the nipple-areola complex (NAC). 6. No clinical, radiological, or pathological evidence of tumor invasion into the NAC, skin, or pectoralis major muscle. The tumor must be confined within the glandular tissue. 7. No evidence of distant metastasis (M0). 8. Clinically node-negative (cN0) as assessed by preoperative examination. 9. No history of neoadjuvant chemotherapy or radiotherapy prior to surgery. 10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 11. Willing and able to understand the study procedures, provide written informed consent, demonstrate good compliance, and agree to participate in follow-up evaluations. 12. The principal surgeon must have experience in performing at least 30 cases of NSM combined with implant-based reconstruction. Exclusion Criteria: 1. Diagnosis of Paget's disease of the breast, recurrent breast cancer, or a history of prior thoracic radiation therapy. 2. Evidence of tumor invasion into the skin (including inflammatory breast cancer), nipple-areola complex, or pectoralis major muscle. 3. Pregnancy or lactation at the time of enrollment. 4. Requirement for re-excision following a prior breast lump biopsy, or a history of any previous breast surgery (including but not limited to augmentation mammoplasty, breast reduction, lumpectomy, etc.). 5. Breast size exceeding a D-cup. 6. Body mass index (BMI) \> 30 kg/m². 7. Grade III ptosis (severe breast drooping where the nipple is positioned below the inframammary fold). 8. Pre-existing nipple-areolar complex deformities (e.g., nipple inversion, areolar hypoplasia), active skin conditions of the breast (e.g., eczema, dermatitis, infection, ulceration), or significant scarring compromising the surgical site. 9. Severe systemic comorbidities (e.g., immunosuppression, uncontrolled diabetes mellitus, severe cardiopulmonary dysfunction, coagulopathy or bleeding diathesis, contraindications to general anesthesia). 10. Known hypersensitivity or allergy to silicone gel implants, or to anesthetic agents/antibiotics used perioperatively. 11. Pre-existing neurological disorders (e.g., diabetic peripheral neuropathy, Parkinson's disease, polyneuritis, spinal cord injury) or chronic use of medications known to affect neurological/sensory function (e.g., antidepressants, antiepileptics). 12. Current heavy smoking (\>20 cigarettes per day). 13. Current alcohol abuse or substance addiction. 14. Concurrent or history of other active malignancies 15. Anticipated poor compliance with follow-up protocols or inability to complete scheduled postoperative evaluations.

Inclusion Criteria: * aged 18-65 years old * scored 10 or above on PHQ-9 * provide informed consent Exclusion Criteria: * having diagnosis of bipolar disorder, psychotic disorders, or substance use disorders

Inclusion Criteria: * Voluntarily participate in the study, be able to understand, and sign the informed consent form. * Aged 18 to 45 years (inclusive) at the time of signing the informed consent form. * Assessed as high-risk for preeclampsia at gestational weeks 11-13, defined as either: A risk value of ≥1/100 based on the simplified Fetal Medicine Foundation (FMF) model, OR A high-risk result from serum biomarker screening (sFlt-1, PLGF, sFlt-1/PLGF ratio). (See Appendix for details) * Gestational weeks 11-13 at enrollment. * Singleton intrauterine pregnancy (confirmed by transvaginal or transabdominal ultrasound). Exclusion Criteria: * History of psychiatric disorder not adequately controlled by medication. * Unexplained vaginal bleeding at screening. * Known uterine malformation. * Evidence of positive serology for HIV, HBV (HBsAg positive), HCV (anti-HCV antibody positive), or syphilis. * Known proliferative retinopathy. * Presence of severe organic disease or any other condition that, in the judgment of the investigator, makes the subject unsuitable for study participation. * Planned or current use of medications with potential drug-drug interactions with human granulocyte colony-stimulating factor (G-CSF) analogs, such as lithium. * Known allergy to rhG-CSF products or their components, or allergy to recombinant human proteins/peptides derived from E. coli.

Inclusion Criteria: diagnosed patients with myofascial pain and TMD for at least six months based on Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), Axis I, age between 20 and 60 years, literate and able to comprehend the questionnaire no prior psychological treatment for pain. Exclusion Criteria: age \<20 or \>60 years, low literacy (less than five years of formal education), history of major psychiatric or neurological disorders, diagnosed joint pathologies (e.g., arthritis, disc displacement with reduction), history of migraine or facial trauma, drug dependency and pregnancy or current use of psychotropic medication.

Inclusion Criteria: * The subject has given their written consent to participate in the trial. * BMI ≥ 18 and ≤ 35 kg/m2. * Primary diagnosis of MDD meeting DSM-5-TR criteria and one of the following episode characteristics: (a)MDD, single episode, moderate (ICD-10-CM: F32.1); (b) MDD, single episode, severe, without psychotic features (ICD-10-CM: F32.2); (c) MDD, recurrent, moderate (ICD-10-CM: F33.1); (d) MDD, recurrent, severe, without psychotic features (ICD-10-CM: F33.2) * Duration of current depressive episode no longer than 12 months prior to screening. * MADRS score ≥ 22 at screening * Willingness to start a new, conventional antidepressant treatment which is chosen by the treating physician with regards to side effect profile and previous treatments, together with KET01, dosed according to the prescribed schedule. * Willingness to terminate any ongoing antidepressant treatment if deemed ineffective by study physician in accordance with clinical practice (tapering or immediate stop), followed by a wash-out phase of at least 7 days without medication before treatment with the new antidepressant is initiated together with KET01. * For females of childbearing potential: Must be willing to undergo pregnancy tests and will be required to use highly effective contraceptive measures from the time of informed consent until 28 days after last IMP intake. Methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral or injectable); implantable intrauterine device (IUD); intrauterine hormone-releasing system (IUS), bilateral tubal occlusion or practicing sexual abstinence (if this is in line with the preferred and usual lifestyle of the participant). * For male participants with a partner of childbearing potential: Must be willing to use adequate contraceptive measures (barrier method) or practice sexual abstinence (if this is in line with the preferred and usual lifestyle of the participant) from the time of informed consent until 28 days after last IMP intake. Note: These requirements also apply for male participants who have had a vasectomy. Exclusion Criteria: * Known hypersensitivity or intolerance to ketamine or any of the excipients. * Pregnancy, breastfeeding or planned pregnancy (if female). * High suicide risk according to the overall assessment of the research physician. * Known psychiatric and neurological concomitant condition of: MDD, single episode, severe, with psychotic features (ICD-10-CM: F32.3), MDD, recurrent, severe, with psychotic features (ICD-10-CM: F33.3), Schizophrenia spectrum and other psychotic disorders (ICD-10-CM: F21, F22, F23, F20.81, F20.9, F25.0, F25.1, F06.0, F06.1, F06.2, F28 and F29) or bipolar disorder (ICD-10-CM: F31), other mental disorder due to known physiological condition (ICD-10-CM: F06). Participants with first-degree relatives (parents, brothers, sisters or children) with psychotic or bipolar disorders are also not considered eligible. Paranoid or schizoid personality disorder (ICD-10-CM: F60.0, F60.1). Antisocial, borderline, histrionic or narcissistic personality disorder (ICD-10-CM: F60.2, F60.3, F60.4, F60.81). Neurodevelopmental disorders, e.g. moderate to profound intellectual developmental disorders (ICD-10-CM: F71, F72, F73), or autism spectrum disorders (ICD-10-CM: F84). * Known or suspected lifetime history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder, epilepsy (excluding uncomplicated childhood febrile seizures with no sequelae) or any other disease/procedure/accident/intervention which, according to the investigator is deemed associated with significant injury to or malfunction of the CNS. * History of significant head trauma within the past 2 years prior to Visit 1. * History of cerebrovascular event (e.g. stroke, prolonged ischaemic neurologic deficit \[PRIND\], transient ischaemic attack). * Known or suspected ongoing cardiac disease (e.g. unstable angina, congestive heart failure, tachyarrhythmia or myocardial infarction). * Clinically significant abnormal electrocardiogram findings at Visit 1 which may jeopardize participant's safety according to the investigator. * Untreated or uncontrolled hypertension (after 5 minutes of rest, systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg confirmed by three sequential measurements with at least 5 minutes between the single measurements). * Laboratory findings suggesting impaired hepatic function or liver cirrhosis i.e. gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values \> 2x times the upper limit of normal (ULN) or total bilirubin \> 1.5 times the ULN at Visit 1. Participants with an isolated increase of indirect bilirubin not previously documented as a diagnosis of Gilbert's syndrome must be discussed with the medical monitor. * Known hepatitis B or C. * eGFR \< 60 mL/min/1.73 m2 or creatinine \> 200 μmol/L at Visit 1 or ongoing dialysis or kidney transplants. * Diabetes mellitus with a haemoglobin A1c (HbA1c) value \> 64 mmol/mol at the screening visit. * Hyperthyroidism. * Uncontrolled hypothyroidism i.e. not at stable treatment with thyroid hormones (triiodothyronine/thyroxine \[T3/T4\]) within the 6 weeks before Visit 1 or abnormal thyroid stimulating hormone (TSH) and free thyroxine (fT4) values at Visit 1. * History (within 5 years before Visit 1) of complicated cystitis (defined as cystitis in males; due to anatomical abnormalities; due to immunocompromised state, in pregnant women; recurrent infections despite adequate treatment; infections occurring after instrumentation such as nephrostomy). * Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the trial, or jeopardise the conduct of the trial according to the protocol. * Previous administration of ketamine (with exception of known or suspected ketamine-anaesthesia) or esketamine. * Prohibited prior and concomitant therapies and medication (see 7.3 Concomitant use of other medicinal products and treatments). * History of moderate to severe alcohol use disorder or substance use disorder, including e.g. benzodiazepines, opiates, ketamine, hallucinogens and related drugs, stimulants (e.g. phencyclidine \[PCP\]), lysergic acid diethylamide \[LSD\], 3,4-methylenedioxymethamphetamine \[MDMA\], dextromethorphan, amphetamines, cocaine) or cannabis, except nicotine and caffeine, within 6 months before Visit 1 or a positive drug abuse test except for allowed medication prescribed for a medical condition. * Participation in other treatment studies. * Ongoing electroconvulsive treatment (ECT) or repetitive transcranial magnetic stimulation (rTMS). * Ongoing compulsory psychiatric care. * Other reason, as assessed by the investigator, that prevents the research subject's participation such as risk that the subject is unable to complete the trial (non-compliance). * Recently started psychotherapy (within 6 weeks) or planning to start such treatment during participation in the trial.