cyrilzakka/clinical-trials huggingface dataset:
Study of Ketamine as an Antidepressant in Major Depressive Disorder

Primary Outcome Measures:

Evaluate the changes in neuroimaging and biochemistry measures with ketamine treatment.

Secondary Outcome Measures:

Evaluate the effects of ketamine on depression symptoms, manic symptoms, global change in psychiatric symptoms, and suicidal ideation.


Eligibility Criteria:
Inclusion Criteria:Male patients, ages 18 to 65 years with a diagnosis of MDD, currently depressed or in a current major depressive episode of BD without psychotic features will be recruited into this substudy.

Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial.

Exclusion Criteria:Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, subjects who currently are using oher antidepressant drugs in the 2 weeks prior to screen and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines) urine test at screening.

Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.

Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.

Clinically significant abnormal laboratory tests.

Subjects with clinical hypothyroidism or hyperthyroidism.

Subjects with one or more seizures without a clear and resolved etiology.

Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip).

Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, or who have a MADRS item 10 score
Implantable Long-Acting Pre-Exposure Prophylaxis for MSM

The long-term goal of this project is to better understand factors at the patient and physician level that can be addressed to impact uptake of long-acting, implantable PrEP (LA-PrEP) products in the future and identify the training needs of physicians. This project specifically focuses on men who have sex with men (MSM) seen in primary care settings in Texas. The main objective of this project is to examine perspectives of MSM and physicians in Texas regarding LA-PrEP, including attitudes and barriers to use and implementation by interviewing patients and physicians from the same clinical practices.

The long-term goal of this project is to better understand factors at the patient and physician level that can be addressed to impact uptake of long-acting, implantable PrEP (LA-PrEP) products and identify the training needs of physicians. This project is based on the hypothesis that specific barriers to uptake of LA-PrEP may exist that must be addressed to support widespread implementation in primary care settings in the future. Primary care settings are the ideal setting for new PrEP medications that employ innovative strategies for use, including implantable formulations, particularly among men who have sex with men (MSM). Primary care settings have demonstrated acceptability for other implantable medications, and similar strategies may be helpful for uptake of PrEP. However, new training and strategies will be needed for physicians to use this type of product with their patients should it become available. At this time, little is known about physician willingness to do the procedures required to insert the implant and what training will be needed. In particular, it is important to assess what training may be needed to effectively engage in health conversations with MSM patients. Thus, the main objective of this project is as follows: To examine perspectives of MSM (n=50) and physicians (n=20) in Texas regarding LA-PrEP, including attitudes and barriers to use and implementation by interviewing patients and physicians from the same clinical practices.

Eligibility Criteria:
Inclusion Criteria:

* Patients must meet the following criteria:

  1. be a patient of one of the practices where physicians have agreed to participate;
  2. be aged 18-45;
  3. be assigned male sex at birth and report having one or more male sexual partners in the past year; and
  4. be HIV negative.
* Physicians who are interested in participating must be a practicing primary care physician in the Dallas, San Antonio, or Austin metropolitan area and be willing to allow recruitment of patient participants from their practice.

Exclusion Criteria:

* Those individuals who speak a language other than English or Spanish will be excluded as well as those who present with a cognitive or other impairment that would prevent them for consenting to participate in the study.
Effect of Head Rotation on Overlap and Relative Position of Internal Jugular Vein to Carotid Artery in Infants and Children: A Study of the Anatomy Using Ultrasonography

Effect of head rotation on overlap and relative position of internal jugular vein to carotid artery in infants and children: A study of the anatomy using ultrasonography.


Eligibility Criteria:
Inclusion Criteria:

* Paediatric patients scheduled for elective urologic surgery were enrolled on a convenience basis, irrespective of their diagnosis or whether central venous access was planned.

Exclusion Criteria:

* Infants or children with possible c-spine disorders or haemodynamic instabilities.
Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study

The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* The child must have completed study 2-54-52014-143
* The child must have an effective response to 2 injections of triptorelin 11.25 mg according to investigator's evaluation with no significant treatment side effects

Exclusion Criteria:

* The patient has a known hypersensitivity to any of the test materials or related compounds
* The patient is unable or unwilling to comply fully with the protocol
Diurnal Ramadan Fasting on Appetite Hormone and Metabolic Profile Among Lean, Obesity, Diabetics

Diabetes Mellitus individuals are known to have dietary rules, namely regulating the amount, type and time of eating. Ramadan fasting seems to be beneficial for people who want to reduce their weight, but it is not easy for diabetic patients. Because of its distinctive features, Ramadhan induces changes in eating habits, calorie consumption, sleeping patterns, and daily physical activity, which may contribute to changes in hunger-satiety responses and glicemic control. Examining changes in gut hormones during Ramadan fasting may reveal whether this observance could change glucose metabolism in diabetics without triggering the undesirable effect of gluconeogenesis. The proportions of fat, protein, and carbohydrate in meals vary between outside and within Ramadan. Alterations in timing and composition meal during Ramadan lead to reduced food intake may affect gut hormones and metabolic responses. The aim of this study to determine whether the effect of Ramadan fasting differed in people with DM patients, pre-DM and healthy individuals, with respect to gut hormones, body composition, metabolic parameters, and glycemic control

The experimental study was performed during and after Ramadan fasting in 2021 (April to May) in Semarang, Indonesia. The present study was performed using the quasy-experimental method by pre-post measurement of three experimental groups (diabetics, Obese and healthy subjects) selected using the purposive sampling methods

Eligibility Criteria:
Inclusion Criteria:

* Diabetics subjects: glucose fasting plasma \> 200 mg/dL, with aged 35-60 years and body mass index above 25 kg/m;
* Obese subjects: body mass index above 25 kg/m2 with aged 35-60 years and waist circumference for men \>90 cm, for women \> 80 cm
* Lean subjects: body mass index below 23.5 kg/m2 with aged 35-60 years and waist circumference for men \<90 cm, for women \< 80 cm

Exclusion Criteria:

* experienced weight loss more than 10% from the actual weight in the last three months
* consumed medicine or supplement for weight loss diet, •. had the history of evidence of clinical depression, cognitive disorders, heart disease, cancer, liver or renal disease, chronic pulmonary disease, uncontrolled hypertension, physical disability, or other contraindications
Doxorubicin Hydrochloride Liposome as First-Line Therapy in Treating Older Women With Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well doxorubicin hydrochloride liposome works as first-line therapy in treating older women with metastatic breast cancer.

OBJECTIVES:

Primary

* Evaluate the effectiveness of pegylated liposomal doxorubicin hydrochloride, in terms of objective response rate, in elderly women with metastatic breast cancer.

Secondary

* Determine the feasibility of this drug in these patients.
* Evaluate chemotherapy-induced toxicities in these patients.
* Assess the disease-free survival and overall survival of these patients.
* Study the geriatric covariates.
* Assess the covariates predictive of the hematopoietic reserve and the risk of febrile neutropenia in these patients.

OUTLINE: This is a multicenter study.

Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60-90 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity or progressive disease.

After completion of study therapy, patients are followed up periodically for 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed invasive ductal or lobular adenocarcinoma of the breast

  * Metastatic disease as confirmed by ≥ 1 of the following:

    * Histology or cytology
    * Radiology
    * Elevated CA 15-3 levels
* No HER2/neu overexpression by IHC or FISH
* Measurable (≥ 10 mm) or evaluable disease

  * Bone lesions or isolated pleural effusion allowed
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Postmenopausal
* Life expectancy \> 3 months
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
* Alkaline phosphatase ≤ 5 times ULN
* Bilirubin ≤ 2 times ULN
* Creatinine clearance ≥ 30 mL/min
* LVEF ≥ 50%
* No congestive heart failure or other uncontrolled cardiac disease
* No other malignancy within the past 5 years except for curatively treated carcinoma in situ of the cervix, urothelial in situ carcinoma, or basal cell cancer
* No prior hypersensitivity to anthracyclines
* No psychological, familial, social, or geographical reason that would preclude study follow-up
* No serious illness or physical or mental condition resulting in a permanent disability that may preclude successful treatment

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy for metastatic disease
* Prior adjuvant chemotherapy allowed

  * No development of metastatic disease within 6 months after completion of adjuvant anthracycline-based chemotherapy
* No more than 300 mg/m² of prior doxorubicin hydrochloride or 600 mg/m² of prior epirubicin hydrochloride in the adjuvant setting
* More than 30 days since prior participation in another clinical trial
Prospective, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products

The purpose of the study is to evaluate the effectiveness of Elocta compared to conventional factor products in the prophylactic treatment of patients with haemophilia A over a 24-month prospective period. Data will also be collected for a 12 month retrospective period.


Eligibility Criteria:
Inclusion Criteria:

* Male patients with a diagnosis of haemophilia A
* Received prophylactic treatment with a factor product for management of haemophilia A in the 12 months prior to enrolment
* At enrolment prescribed prophylactic treatment with Elocta or conventional factor product regardless of participation in the study
* Having at least 12 months documented pre-study treatment data regarding prophylactic treatment prescriptions and bleeding episodes prior to the baseline visit
* Signed and dated informed consent provided by the patient or the patient's legally acceptable representative for patients under the legal age before any study-related activities are undertaken. Assent should be obtained from paediatric patients according to local regulations

Exclusion Criteria:

* Enrolment in a concurrent clinical interventional study involving intake of an investigational medicinal product (IMP), within 1 year prior to enrolment
* Previously treated with commercially available extended half-life products other than Elocta
* Presence of factor VIII inhibitors (≥0.60 Bethesda Unit \[BU\]/mL ) at the latest available inhibitor test using the Nijmegen modified Bethesda assay
Study of Innovative Strategies for Mitral Valve Repair

The goal of this observational study is to compare the safety and effectiveness of a 3-steps standardized repair-oriented strategy with annuloplasty only in pediatric patients with mild to moderate mitral valve regurgitation.

The main questions it aims to answer are:

* Can 3-steps standardized repair-oriented strategy improve both left ventricular and mitral valve function in pediatric patients with mild to moderate mitral valve regurgitation?
* Can surgical complications caused by the 3-steps standardized repair-oriented strategy be non-inferior (clinically acceptable) to annuloplasty only? Participants will be assigned to either the Standardized Group (including subvalvular apparatus rehabilitation (leaflet plication if chordae absent on leaflet margin, mal-connected chordae resection if chordae mal-connected to leaflet body, papillary muscle splitting if short chordae or dysplastic or fused papillary muscle etc.), leaflets repair (leaflets plication if functional leaflet prolapse, leaflet cleft closure and patch augmentation for anatomical leaflet defect, etc.) and annuloplasty (posterior annuloplasty for annular dilatation and shallow leaflet coaptation, etc.)) or the Annuloplasty Group (annuloplasty only during mitral repair surgeries. Additionally, echocardiography, electrocardiograms, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of surgery and at 1 months, 3 months, and 6 months after mitral repair.

Researchers will compare the Standardized Group and the Annuloplasty Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 6 months of surgery, is lower in the former than in the latter.


Eligibility Criteria:
Inclusion Criteria:

* \< 14 years old
* had not undertake mitral valve surgery before
* moderate to severe mitral regurgitation

Exclusion Criteria:

* moderate to severe mitral regurgitation which concommitant with other cardiac malformation which can not be correct or can only perform palliative surgery
* concommitant with mitral stenosis
* ischemic mitral regurgitation (for example, concommitant with anomalous origin of coronary artery)
* Barlow syndrome
* dysplasia of mitral leaflet
* complete/Partial endocardial cushion defect
* common atrioventricular valve
* atrioventricular common channel
* cardiomyopathy
* other mitral valve surgery contraindications
Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection

This is a phase 2 study in which subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 alone or in combination with pegylated interferon alfa-2a and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of ages 18 - 65
* Chronic HBV infection for \>/= 6 months

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
* Significant fibrosis or cirrhosis
* History or evidence of drug or alcohol abuse
* History of intolerance to SC injection
* History of chronic liver disease from any cause other than chronic HBV infection
* History of hepatic decompensation
* Any prior receipt of an interferon product
Choline PET/CT and MRI for Targeted Prostate Biopsy

This research study will access the using of a radiotracer, 18F-choline PET/CT and MRI for prostate cancer in patients undergoing diagnostic prostate biopsy. Patients receive MRI guided prostate biopsies and metabolomic profiling of prostate biopsy tissues.

This is an explorative diagnostic basic research study to assess the value of 18F-choline PET/CT and multi-sequence MRI for prostate cancer in patients undergoing diagnostic prostate biopsy. Patients will receive image-guided (targeted) prostate biopsies and metabolomic profiling of prostate biopsy tissues to evaluate underlying metabolic changes in comparison with pathological Gleason grading.

Eligibility Criteria:
Inclusion Criteria:

* Males 40 years of age or older scheduled for prostate biopsy (for known or suspected prostate cancer) followed by planned prostatectomy (population group A)
* Males 40 years of age or older with known (biopsy-confirmed) primary adenocarcinoma of the prostate undergoing active surveillance scheduled for prostate biopsy (population group B)

Exclusion Criteria:

* Androgen ablation (hormone treatment) within the last 3 months
* Prostate biopsy within 6 weeks prior to PET or MRI imaging
* Active inflammatory bowel disease within the last 6 months
* Acute prostatitis within the last 6 months
* A non-urologic bacterial infection requiring active treatment with antibiotics
* Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
* Previous radiation treatment of the pelvis
* Symptomatic distal rectal stenosis
* Known hypersensitivity to glucagon
* Pheochromocytoma, insulinoma or galactosemia
* Insulin-dependent diabetes
Treatment Protocol to Monitor the Safety of a 200 mg Dose of Bicalutamide in Patients With Advanced Prostate Cancer

This is an open label, single-centered treatment protocol designed to monitor the safety of patients treated with a 200 mg daily dose of CASODEX. Patient will receive CASODEX as long as physician feels that he is benefiting from this form of therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate gland
* Patients with advanced prostate cancer
* Adult male over the age of 18 years old
* Normal liver function (AST \< 2 x Upper Limit Normal)

Exclusion Criteria:

* ECOG performance status of 4.
* Previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last 5 years.
Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients

This study aims to investigate metabolic effects of a standardized green tea extract, containing a defined amount of epigallocatechin-3-gallate (EGCG), in multiple sclerosis patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsing-remitting multiple sclerosis
* stable treatment with glatiramer acetate at least 6 months prior to inclusion
* Expanded disability status scale \< 4.5
* Normal weight, overweight

Exclusion Criteria:

* Primary or secondary progressive forms of multiple sclerosis
* Clinically relevant heart, lung, liver, kidney diseases
* Habitual caffeine intake over 300 mg per day
* Habitual consumption of green tea
* Alcohol or drug abuse
Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA

The objective of this study is to evaluate the feasibility and effectiveness of immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline, Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia (SAA) as a primary therapy. The primary endpoint is the response rate (complete response (CR) + partial response (PR)) at day 180 after the start of IST. Secondary endpoints include evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse rate and overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Acquired aplastic anemia
* Age: younger than 70 years old
* Severity: SAA, VSAA.
* Interval between diagnosis and registration \<6 months.
* Written informed consent from the caretakers and/or whenever possible consent from the patient.

Exclusion Criteria:

-
Evaluation of Comprehensive Geriatric Assessment and Laboratory Biomarkers in Elderly Patients With Multiple Myeloma

This study evaluates the association between a comprehensive geriatric assessment and laboratory biomarkers with the side effects of chemotherapy in older patients with multiple myeloma (MM). The comprehensive geriatric assessment is a tool that can help to determine how fit a patient is. It is composed of a series of questions and tests designed for older people to evaluate their physical function, mental status, mental health, nutritional status, social support, level of social activity, and the presence of other medical problems. In addition to geriatric assessment domains, laboratory biomarkers may provide information on physiologic dysfunction as a measure for evaluation of frailty in the cancer setting. This study will help researchers in the future by predicting which patients will have more side effects with chemotherapy based on their comprehensive geriatric assessment and laboratory biomarkers, which will allow adjustments to treatment in older adult patients with MM.

PRIMARY OBJECTIVE:

I. To evaluate the association between a baseline comprehensive geriatric assessment (cGA) and chemotherapy toxicity in the first 4 months of treatment measured by treatment-related adverse events, patient-reported outcomes (PROs), and treatment discontinuation in older patients (\>= 65 years) with multiple myeloma (MM).

SECONDARY OBJECTIVES:

I. To evaluate the association between a baseline cGA and baseline disease- and host- related laboratory characteristics and cytogenetic risk profile by fluorescence in situ hybridization among newly diagnosed older (\>= 65 years) patients with MM.

II. To evaluate how the cGA changes over 4 months from the start of treatment and the association between those changes and treatment response in older patients (\>= 65 years) with MM.

III. To evaluate the association between proposed frailty biomarkers at baseline and treatment toxicity in the first 4 months of treatment measured by treatment-related adverse events, PROs, and treatment discontinuation in older (\>= 65 years) patients with MM.

OUTLINE: This is an observational study.

Patients complete surveys and undergo cGA, blood sample collection, and electronic health record (EHR) review on study.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 65 years
* Diagnosis of MM based on International Myeloma Working Group (IMWG) diagnostic criteria
* Newly diagnosed or have received 1 prior line of treatment
* Planned to start a new treatment for MM within 30 days
* Transplant eligible or ineligible
* Fluent in English (all assessment tools are in English)
* Able to provide written informed consent

Exclusion Criteria:

* Received \> 1 prior line of treatment
* Patients included in an interventional therapeutic trial
* Not able to give informed consent
* Severe mental or cognitive disorder precluding geriatric assessment