cyrilzakka/clinical-trials huggingface dataset:
Antenatal Yoga Intervention for Depressed and Anxious Women

The aim of this study is to determine if a hospital-based antenatal yoga program (HB-AYP) is a feasible, acceptable and potentially efficacious intervention for women with antenatal anxiety and/or depression?

Anxiety and depression are the most common psychological symptoms reported in pregnant women and can result in adverse obstetric, neonatal and post-partum mental health outcomes. Although there is a range of effective first-line treatments for anxiety and depression, these treatments are not without limitations. Concerns about the safety of antidepressant medication during pregnancy, lack of access to affordable psychosocial treatments and reluctance to seek mental health care due to stigma may prevent pregnant women from receiving optimal care for their symptoms. Recently, there has been growing interest in alternative and complementary approaches to manage anxiety and depression. These approaches may offer women with antenatal anxiety and depression an alternative treatment option that may be more acceptable and perceived as more holistic and less stigmatizing than conventional mental health care. One way to optimize access to yoga therapy during prenatal care is to implement an antenatal yoga program within a public healthcare system. Accordingly, the overarching aim of this study is to evaluate the feasibility of a hospital-based antenatal yoga program (HB-AYP) plus treatment as usual for anxiety and depression, and obtain preliminary data on its potential efficacy relative to treatment as usual plus biweekly clinical monitoring(TAU) This pilot research will provide much needed preliminary data that will set the foundation for designing a fully-powered prospective randomized controlled trial (RCT) of a HB-AYP. In the long term, it is hoped that this line of research will influence evidence-based clinical guidelines for managing antenatal anxiety and depression and service delivery.

Eligibility Criteria:
Inclusion Criteria: Healthy women in their second trimester of an uncomplicated pregnancy with elevated levels of anxiety and/or depression (based on the PHQ-9 and GAD-7) will be eligible to participate

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Exclusion Criteria: i) a lifetime history of psychosis, ii) symptoms of mania/hypomania in the past 12 months; iii) a history of substance use disorders in the last 6 months; iv) a history of self-harm in the last 6 months; v) high suicide risk; vi) engaged in a regular formal meditative practice at least once a month over the past 12 months; and vii) yoga postures are contraindicated.
Financial Incentives and Weight Loss in Failed Bariatric Surgery

This national, prospective, multicenter, and randomized study seeks to evaluate the effect of financial incentives on weight loss in individuals who experience weight regain following bariatric surgery. The study also aims to conduct a cost-utility analysis to measure the effectiveness of the intervention and assess the potential budgetary implications if it were to be implemented on a wider scale.

Our intervention is based on the principle of "contingency management" whereby financial rewards are contingent upon meeting specific weight loss targets. To assess the effectiveness of this approach, patients who have experienced weight regain after bariatric surgery will be randomly assigned to one of three groups. Group 1 will receive the standard care that includes setting a weight-loss target based on the weight achieved at 12 months post-bariatric surgery following the standard multidisciplinary follow-up at the inclusion center. Group 2 will receive the same treatment as the control group (Group 1), but with an additional financial incentive if the weight loss target (corresponding to the weight they reached 12 months after bariatric surgery) is achieved 12 months after inclusion. Group 3 will receive the same treatment as the control group (Group 1), but the financial incentive will be proportional to the actual weight loss achieved relative to the weight loss target (corresponding to the weight they reached 12 months after bariatric surgery).

The study will include a standard post-bariatric surgery follow-up visits scheduled at 6, 12, 18, and 24 months, as per routine practice. At the 12-month visit, participants will be eligible to receive a financial incentive based on their arm assignment and the extent of weight loss achieved. After the 12-month visit, participants will not receive any additional financial incentives until the 24-month visit.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years of age
* Patients with a history of adjustable gastric banding, sleeve gastrectomy, gastric bypass or SADI-sleeve surgery
* Patient with a post-operative delay of more than 2 years
* Patient who has gained ≥10% of the maximum weight lost
* Patient still obese (body mass index ≥ 30 kg/m²) after surgery

Exclusion Criteria:

* Pregnant women
* Women of childbearing potential planning a pregnancy during the first year of the study
* Persons under legal protection (safeguard of justice, guardianship, curatorship, etc.)
Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects

A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be evaluated. Antiviral activity will also be assessed in HCV-infected subjects.


Eligibility Criteria:
Inclusion Criteria:

All subjects

* Subjects are in good general health.
* Subjects have provided written informed consent form.
* All subjects of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug. HCV Subjects
* Documented clinical history compatible with chronic hepatitis C without cirrhosis.
* Treatment-naïve
* HCV Genotype 1

Exclusion Criteria:

All subjects

* Pregnant or breastfeeding
* Co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
* Decompensated liver disease
* Other clinically significant medical conditions or laboratory abnormalities.
Comparison of Compounded Topical Anesthetics

The primary objective for this pilot study is to evaluate the efficacy of the compounded topical anesthetic Benzocaine 20%/ Lidocaine 8%/Tetracaine 4% (BLT) compared to 4% Lidocaine topical in providing relief of pain during IPL, PDL, and microneedling procedures.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18, but not more than 75 years of age.
* Patients who have a regularly scheduled dermatology appointment for Intense Pulse Light (IPL), Pulse Dye Laser (PDL), or microneedling.

Exclusion Criteria:

* Any subject who has a previous history of allergy, sensitivity, and contraindication to benzocaine, lidocaine, or tetracaine.
* Patients with cardiac/respiratory disease, seizure disorder, or neuropathies.
* Patients who are under treatment for a dermatologic condition that may interfere with the evaluation of the study.
* Pregnant women and women who are breastfeeding.
* Patients who report concurrent use of anxiolytics or opiates, which may interfere with the interpretation of results.
Study of Early-stage Lung Adenocarcinoma for Early Detection and Effective Treatment Strategy

to determine the values of imaging and genetic biomarkers for prediction of tumor aggressiveness and prognosis in patient with early stage lung adenocarcinoma to Identify unique copy number alteration in patient with early stage lung adenocarcinoma to evaluate the long-term change of ground-glass nodule combined with lung adenocarcinoma to suggest a guideline for planning an appropriate follow-up examination and management


Eligibility Criteria:
Inclusion Criteria:

* A. Clinically and radiologically suspected lung adenocarcinoma
* B. Newly-diagnosed Stage I or II from the clinical work up including PET/CT
* C. Performance status of 0 to 1 on the ECOG scale
* D. Age 20 years or older
* E. Able to tolerable DECT imaging required by protocol
* F. Able to give study-specific informed consent

Exclusion Criteria:

* A. Prior malignancy
* B. planning of Definitive RTx 나 neoadjuvant CCRTx
* C. Poor cardiopulmonary reserve
Effect of Lactoferrin in Pneumonia Treatment

Pneumonia is defind as the inflammation of lung tissue caused by an infectious agent that results in acute respiratory signs and symptoms. Community acquired pneumonia (CAP) is a major cause of morbidity and increased health care costs. In developing nations, pneumonia remains a significant cause of mortality in children.

Pneumonia occurs in 30 to 45 of every 1,000 children under 5 years of age; it is less common in 5- to 9-year olds (16 to 22/1,000) and in older children (7 to 16/1,000).

Streptococcus pneumoniae is the primary bacterial cause of pneumonia in infants and children. Viral etiologies become less prevalent and mycoplasmal and chlamydial infections become more prevalent with increasing age

Lactoferrin (LF) is iron-binding glycoprotein of the transferrin family that is expressed and secreted by glandular cells and is found in most body fluids . It appears at especially high concentrations in mammalian milk and was first identified in bovine milk , and was subsequently isolated from human milk.

LFs bacteriostatic function is due to its ability to take up the Fe3+ ion, limiting use of this nutrient by bacteria at the infection site and inhibiting the growth of these microorganisms as well as the expression of their virulence factors .

Eligibility Criteria:
Inclusion Criteria:

* Pneumonia patients
* from the age of one month to the age of 18 years .

Exclusion Criteria:

Neonates and any children with :

* immune deficiency
* congenital heart disease
* neuromascular disorder
* genetic syndromes
Understanding Family Refusal

The investigators plan a secondary data analysis of an existing dataset to examine how individual decision-making differs from family decision-making in organ donation.


Eligibility Criteria:
Inclusion Criteria:

* Citizens or permanent residents of Singapore
* Above 21

Exclusion Criteria:

- Below 21
Sexual Dysfunction And Hypotestosteronemia In Patients With Obstructive Sleep Apnea Syndrome

Obstructive Sleep Apnea Syndrome (OSAS)is a common disease and is suspected to be associated with sexual dysfunction. Our purpose is to sudy the effect of CPAP (Continuous Positive Airway Pressure) treatment on patients' sexual dysfunction by measuring testosterone levels before and after CPAP treatments.

Obstructive Sleep Apnea Syndrome(OSAS) is a highly prevalent disease in the population, affecting at least 4% of males and to a lesser extent females, yet it is currently under diagnosed. OSAS is associated with various disorders including cardiovascular disease, insulin resistance, diabetes mellitus, fatigue and erectile dysfunction. Currently the standard treatment for OSAS is Continuous Positive Airway Pressure(CPAP).

Low testosterone levels are present in some patients with OSAS leading to erectile dysfunction. However, the true prevalence of low testosterone levels and its correlation with sexual health is poorly understood and undefined. Prior data suggest treating these patients with CPAP therapy, usually increases testosterone levels, but unclear if this makes any meaningful difference in patient outcome, that is improvement in libido and sexual function.

There are several postulations to the pathophysiology of low testosterone levels in patients with OSAS. CRP(C-reactive protein), a strong marker of inflammation was shown to be elevated in patients with OSAS. The association between elevated CRP and low testosterone level would support the notion that inflammation plays a primary role in sexual dysfunction in patients with OSAS.

The objective of this study is to identify correlation between low free testosterone levels, sexual dysfunction and Obstructive Sleep Apnea before and after treatment with CPAP. Evaluate the role of CRP and inflammation secondary to OSAS in the pathogenesis of sexual dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Adult males ages 18-70 with newly diagnosed OSAS documented by all-night polysomnography (PSG)

Exclusion Criteria:

* Currently on testosterone replacement therapy
* Prior known cause of erectile dysfunction
* Patients with prior treatment of erectile dysfunction
* Co-morbid conditions like diabetes, hypertension, as well as patient medications, will be recorded, and will not be part of the exclusion criteria
Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories

A randomized, multi-center, double-blind, three arm placebo-controlled study in male and non-pregnant, non-lactating female subjects aged 18 years to examine the safety and efficacy of two dosing regimens of hydrocortisone acetate 90 mg suppository administered with the Sephure applicator for the treatment of ulcerative colitis of the rectum.

Hydrocortisone acetate 90 mg or placebo will be administered as a rectal suppository with a Sephure suppository applicator. Two arms of the study will receive different dosage regimens of hydrocortisone acetate, and the third arm will receive placebo. All subjects will administer the study drug twice a day; once in the morning and once in the evening for 28 days.

The study population will consist of male and non pregnant, non lactating females aged 18 years and older with a confirmed diagnosis of active UC of the rectum.

Eligibility Criteria:
Inclusion Criteria:

* Male or non pregnant, non lactating females aged 18 years and older.
* Subjects with a confirmed diagnosis of active UC of the rectum, extending no more than 15 centimeters (cm) (5.9 inches) proximal to the anal verge as assessed by colonoscopy performed at Visit 2. Note: Subjects may have a history of more extensive UC (e.g., pancolitis), but have active disease only in the rectum at the time of enrollment.
* Modified Mayo sub score for stool frequency of 1 3.
* Modified Mayo sub score for rectal bleeding of 0 2.
* Modified Mayo endoscopic sub score of 2 3.
* Total Modified Mayo Score (without physician global assessment) of 4-8.

Exclusion Criteria:

* History or current diagnosis of bacterial or other infectious colitis, radiation enteritis and radiation proctitis, Crohn's disease, collagenous colitis and indeterminate colitis.
* Prior gastrointestinal surgery except appendectomy, cholecystectomy, and hernia.
* Concomitant active lower gastrointestinal disease (except Irritable Bowel Syndrome) or distortion of intestinal anatomy.
* Bleeding hemorrhoids at the time of enrollment.
* Acute diverticulitis at the time of enrollment.
* Acute or chronic pancreatitis at the time of enrollment.
* Unmanaged celiac disease at the time of enrollment.
* Positive stool test for enteric pathogens, Clostridium difficile, or presence of ova and parasites.
* Taking a prohibited medication.
Remote Telemonitoring to Improve Prehabilitation and Surgical Outcomes of Patients Undergoing Elective Abdominal Surgery

There is data confirming that simple tests of physical capability, such as the timed "get-up-and-go" test and the 6-minute walk test, correlate with surgical outcomes. It is reasonable to assume that preoperative telemonitoring, which allows for the tracking of more variables over a wider range of activities, could provide a significantly more accurate picture of a patient's physical fitness than a short one-time test performed in the clinic setting.

Almost half of the patients who are readmitted at Washington University are readmitted for less than 4 days. The readmitted patients usually present with sepsis, are treated with antibiotics and percutaneous drainage, and are discharged home relatively quickly. Earlier identification of these patients, prior to the development of sepsis, would reduce the risks to the patient and allow for outpatient management.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo elective abdominal surgery
* At least 18 years of age
* Able to understand and willing to sign an IRB-approved informed consent document

Exclusion Criteria:

* Doesn't have access to smartphone
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients

The purpose of this study is to determine the amount of ertapenem in the blood over time between hemodialysis session.

After a hemodialysis session, subject will be administered ertapenem and the amount of ertapenem in the blood will be measured at seven time periods before the initiation of the next hemodialysis session.

Eligibility Criteria:
Inclusion Criteria:

* Men or women age between 18 and 88 at the time of admission to Oakwood Hospital and Medical Center during January 1, 2014 or date of Institutional Review Board (IRB) approval to December 1, 2015
* Diagnosed with end stage renal disease and requires hemodialysis three times a week
* No allergy to β lactam medications
* Existing IV access for parenteral ertapenem infusion
* Willing for blood draws, at predose, 0.5, 1, 2, 6, 12 hours post-hemodialysis and pre-hemodialysis for the following hemodialysis and immediately post hemodialysis session and 1 hour post.
* No evidence of hepatic disease
* No history of alcoholism or drug abuse within pervious 2 years
* Not pregnant

Exclusion Criteria:

* History of any form of epilepsy, seizure or convulsion
* Currently taking any forms of valproic acid or divalproex sodium for treatment of any disease states
* Currently taking probenecid
* Current Clostridium difficile (C. diff.) infection, defined as 30 days prior to day-1 of receiving ertapenem for this study
* Currently receiving any antimicrobial agents for prophylaxis or treatment
A Trial to Assess the Antipsychotic Efficacy of ITI-007

The study will be conducted as a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.


Eligibility Criteria:
Inclusion Criteria:

* male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia
* experiencing an acute exacerbation of psychosis

Exclusion Criteria:

* any subject unable to provide informed consent
* any female subject who is pregnant or breast-feeding
* any subject judged to be medically inappropriate for study participation
Registry of Guardant360® Use and Outcomes In People With Advanced Cancer

The purpose of this registry is to collect data that describes the characteristics of people with advanced cancer for whom the Guardant360 assay is ordered and to observe their clinical outcomes after receiving their results.

This is a prospective, descriptive registry of people with advanced cancer for whom a Guardant360 assay has been ordered by their health care providers. The registry is divided into modules according to primary cancer diagnosis. Module 1 includes subjects with advanced NSCLC with additional modules added later in the study.

All eligible people for whom blood for a Guardant360 assay has been collected will be invited to participate in the registry. Subject demographics and relevant medical history will be collected at the time of enrollment. Information on tumor molecular testing, treatment decisions, and clinical outcomes from the time of enrollment will be collected in a prospective manner. The registry does not require any specific treatments or procedures but rather collects information on the treatment journey of each participant. Subjects may participate in other clinical studies while also participating in GEODE.

Eligibility Criteria:
General Inclusion Criteria:

1. 18 Years of age or older
2. Ability to provide written informed consent
3. Blood collected for the most recent Guardant360 test within 8 weeks prior to enrollment

General Exclusion Criteria

1. Pregnancy at the time of the qualifying Guardant360 blood collection
2. History of the allogeneic organ or tissue transplant

Module 1 (Non-Small Cell Lung Cancer)

Inclusion Criteria

1. NSCLC, confirmed by histology or cytology
2. Advanced disease, defined as: stage IIIB or IV NSCLC at the time of the qualifying Guardant360 blood collection; or for subjects with an initial diagnosis of Stage I-IIIA disease, NSCLC that is recurrent or metastatic at the time of the qualifying Guardant360 blood collection
3. One of the following conditions at the time of the qualifying Guardant360 blood collection:

   * No prior systemic therapy for advanced disease OR
   * All three of the following conditions:

1. A history of prior systemic therapy for advanced disease, 2. Disease progression within the previous four weeks, \& 3. No new systemic therapy for advanced disease

Exclusion Criteria Subjects with a diagnosis or history of any cancer involving the lung that is not classified as NSCLC, including but not limited to small cell carcinoma, neuroendocrine or carcinoid tumor, lymphoma, mesothelioma, metastatic non-lung carcinoma, or cancer of unknown primary.
Audit and Screening Study to Determine the Prevalence of Peripheral Arterial Disease

The primary objective of the study is to establish the prevalence of lower extremity peripheral arterial disease (PAD), defined as an ankle-brachial index of less than or equal to 0.9, in subjects with at least two of the specified cardiovascular disease (CVD) risk factors, with no overt cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 45 years or above or females aged 55 years or above (age related CVD risk factor).
* At least two other risk factors for CVD: cigarette smoking, diabetes mellitus, hypertension, low HDL or high LDL cholesterol, strong family history of coronary heart disease, elevated waist circumference, Aboriginal and/or Torres Strait Islander.
* Willingness to participate in study and sufficient command of the English language to read and complete study questionnaire.

Exclusion Criteria:

* Less than 2 risk factors for CVD (other than age), symptoms of PAD, coronary heart disease or coronary heart disease risk equivalents
* No lipid data collected in the last 12 months
* Serious or unstable medical or psychological conditions that, in the opinion of the Investigator, would compromise safety or successful participation in the study.
Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation

This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a previously studied oral tablet formulation under fasting conditions, and to assess the effect of a high fat, high calorie meal on the pharmacokinetics (PK) of linaprazan glurate and the active substance linaprazan after the administration of the new oral tablet formulation.


Eligibility Criteria:
Main Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the study.
2. Healthy male or female aged 18 to 65 years, inclusive.
3. Body mass index ≥18.5 and ≤30.0 kg/m2.
4. Medically healthy, without abnormal clinically significant medical history
5. Female subjects of childbearing potential, as well as their partners and male subjects and their partners, who agree to using methods of contraception
6. Willing and able to consume the high-fat, high calorie breakfast

Exclusion Criteria:

1. Female subjects of childbearing potential unless they agree to use highly effective methods of contraception (failure rate of \<1%) from 2 weeks prior to dosing until the end-of-study visit.
2. Male subjects with a partner of childbearing potential, unless they agree to use method of contraception from 2 weeks prior to dosing until the end-of-study visit.History of or current clinically significant disease as defined in the protocol
3. History of or current clinically significant disease as defined in the protocol.
4. History of GERD, significant acid reflux.
5. Subjects who are pregnant, currently breastfeeding, or intend to become pregnant (female subjects) or father a child (male subjects) during the course of the study (i.e., from screening to end of study visit).