cyrilzakka/clinical-trials huggingface dataset:
Differentiated Service Delivery for Antiretroviral Therapy

This study is a prospective observational cohort. The target study population is PLHIV who receive ART at hospitals and community-based organizations (CBOs) in Chiang Mai, Ubon Ratchathani, Chonburi, and Songkhla. Participants will receive ART service in the same standard as in the hospital setting. Secondary data will be collected from the medical records already existed in the hospital and CBO systems.

DSD-ART service at the Hospital

* Medical examination: All clients who receive ART service at the hospital and agree to participate in the research project will be interviewed to collect personal information and receive physical and laboratory examination in order to assess eligibility in research participation. If ineligible, the clients will be referred to the standard of care.
* Preparation and DSD-ART service offer: PLHIV who are eligible to participate in the research will receive counselling to assess the supports the clients need and will be offered various models of DSD-ART service. The clients may choose the model that is most suitable to their lifestyle.

Eligibility Criteria:
Inclusion Criteria:

1. Thai citizenship
2. Age ≥ 18
3. HIV positive
4. Received ART for at least 6 months at a participating hospital (Except for After hour ART clinic model that will allow participants who receive ART less than 6 months into service)

Exclusion Criteria:

N/A
Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients

This study outlines the safety of the autologous SVF cells injection in the hands of patients with SSc. Preliminary assessments at 6 months will suggest potential efficacy needing confirmation in a randomised placebo-controlled trial on a larger population

In patients with systemic sclerosis(scleroderma, SSc), impaired hand function greatly contributes to disability and reduced quality of life, and is insufficiently relived by currently available therapies. Adipose tissue-derived stromal vascular fraction (SVF) is increasingly recognized as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune disease. The investigators aimed to measure for the first time the safety, tolerability, and potential efficacy of autologous SVF cells local injections in patients with SSc with hand disability.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 year old
* Cochin Hand Function Scale (CHFS) \> 20/90

Exclusion Criteria:

* new vasodilators or immunosuppressive therapy for SSc in the 3 months prior to enrolment
* new vasodilators or immunosuppressive therapy for SSc during the 6-month follow-up
* clinical or radiological signs of digital infection
* positive status for HIV
* positive status for hepatitis B or C
* positive status for human T-cell leukemia virus 1-2
* positive status for syphilis
* pregnancy
* BMI less than 17kg/m2
Focused TTE for Hemodynamic Instable High Risk Patients

Focused transthoracic echocardiography (TTE) is a technique, which allows quick and non-invasive diagnosis and monitoring in hemodynamic instable patients. There are preliminary data supporting the hypothesis that TTE is feasible in the operating theatre.

The purpose of this study is to test the hypothesis that intraoperative focused TTE has an impact on high risk patients´ management when it is added to standard extended monitoring practices in hemodynamic instabilities.

Focused TTE is en emerging matter in anesthesia, intensive care and emergency medicine. The value of intraoperative TTE is unclear. There are preliminary data that it is feasible For intraoperative transesophageal echocardiography (TEE) an impact on cardiac and non-cardiac surgery patients´ management has been shown.

Purpose of this study is to evaluate the application of focused TTE in patients with increased perioperative risk undergoing moderate to high risk surgery who become hemodynamic instable during anesthesia in the operating theatre.

When hemodynamic instability under anesthesia occurs focused TTE is conducted and the obtained diagnostic information are used for further patient management. Any change in management or therapy will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* gender: male, female
* Age ≥ 18 years
* increased perioperative risk, at least one of the following:

  * coronary artery disease
  * congestive heart disease
  * insulin dependent diabetes mellitus
  * renal insufficiency, creatinine \> 2,0 mg/dl
  * cerebrovascular disease
  * Sepsis
* Procedure with at least moderate increased risk

  * intraperitoneal surgery
  * intrathoracal surgery
  * major orthopedic/traumatologic surgery
  * prostatic surgery
  * vascular surgery
* Hemodynamic instability, at least one of the following:

  * Hypotension (systolic blood pressure \< 80 mmHg or mean blood pressure \<50 mmHg) and/or
  * Bradycardia \< 45/min. orr Tachycardia \> 120/min and/or
  * Cardiac index \< 2,0 l/min/m2

Exclusion Criteria:

* cardiac surgery
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery

The purpose of this study is to analyze the efficacy and accuracy of real-time continuous glucose monitoring devices (rtCGM) in patients with Type 2 diabetes undergoing inpatient elective hip or knee surgery in the pre-, peri-, and post-operative setting at Stony Brook University Hospital (SBUH).


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years of age
* Scheduled for elective inpatient hip or knee replacement surgery at Stony Brook University Hospital (SBUH)
* Clinically diagnosed Type 2 Diabetes at least 6 months prior to surgery
* Literate and able to provide written informed consent
* Negative pregnancy test by serum or urine HCG at screening \[as documented in subject's medical record) for women of childbearing potential (WCBP)\]

Exclusion Criteria:

* Less than 18 years of age
* Not scheduled for elective inpatient hip or knee replacement surgery at SBUH
* No clinical diagnosis of Type 2 diabetes at least 6 months prior to surgery
* Not literate or unable to provide written informed consent
* Documented diagnosis of organ failure
* Documented diagnosis of chronic infection
* Documented diagnosis of any active malignancy
* Documented diagnosis of hepatic (liver) dysfunction or cirrhosis
* Pregnant by serum or urine HCG at screening \[as documented in subject's medical record) for women of childbearing potential (WCBP)\]
Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance

This study aims to compare the nighttime heartburn and sleep disturbance improvement effect of Tegoprazan 50mg and Eomeprazole 40mg in patients with ERD patients.

This is a multi-center, double-blind, randomized, active-controlled phase 4 (pilot) study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg)

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged between 19 and 75 years
2. Subjects who have erosive reflux disease

Exclusion Criteria:

1. Unable to undergo upper GI endoscopy
2. Symptoms of primary or secondary esophageal movement disorders
3. Planning or Perform surgery that can affect gastric acid secretion (e.g., upper gastrectomy, Vagotomy, etc.)
EvaluatIng Normal Values for TraditionaL AnorectaL FUnction ParaMeters with AIr Charged and Solid State HRAM CatheTErs ("ILLUMINATE" Study)

The research study will be conducted to obtain baseline, or "normative" information to compare an air charged HRAM catheter to traditional solid catheter measures using the IAPWG standardized testing protocol and London classification.

The primary purpose of this research study is to obtain normative datasets for traditional measures of anorectal function with an air charged HRAM catheter in healthy subjects using the IAPWG standardized testing protocol and London classification for anorectal manometry (ARM) measurement.

A secondary purpose is to qualitatively compare the performance of air charged and solid state HRAM catheters in determining values for traditional measures of anorectal function in a subset of study subjects using the IAPWG standardized testing protocol and London classification for ARM measurement.

Eligibility Criteria:
Inclusion Criteria:

* 1. Male and female volunteers, 18-65 years old
* 2. Willing to provide informed consent
* 3. Willing and able to follow instructions for ARM procedure

Exclusion Criteria:

* 1. Documented history of gastrointestinal disorders such as:
* a. fecal incontinence,
* b. irritable bowel syndrome (IBS),
* c. functional constipation, as defined by two or more of these symptoms for at least 25% of the time over the past 3 months:
* i. excessive straining,
* ii. hard or lumpy stools,
* iii. sensation of incomplete evacuation,
* iv. a feeling of anorectal blockage,
* v. manual maneuvers to facilitate defecation,
* vi. or fewer than 3 bowel movements per week.
* d. functional diarrhea, as defined by the following symptoms over the past 3 months:
* i. Loose or watery stools
* ii. Lack of pain with diarrhea
* iii. Diarrhea occurring in at least 75% of bowel movements
* iv. No identifiable causes
* 2. Use of medications that may affect gastrointestinal motility as determined by healthcare professional.
* 3. Prior pelvic radiation,
* 4. Prior anorectal surgical procedures, including treatment for hemorrhoids,
* 5. Risk factors for pelvic floor trauma:
* a. more than 4 vaginal deliveries,
* b. vaginal delivery with birthweight greater than 4500gms (macrosomia),
* c. known 4th degree perineal tear or known forceps use during delivery.
* 6. Contraindicated for ARM testing
* 7. Has gastrointestinal symptoms and is indicated for ARM testing
* 8. Subject is currently pregnant or plans to become pregnant during the course of their enrollment in the study, as self-reported.
Protective Antibody Level After COVID-19 Vaccination Among Patients Under Hemodialysis

The aim of the study is to evaluate the level of neutralizing antibody against SARS-CoV-2 after COVID-19 vaccination in patients under hemodialysis. To this end, the level of neutralizing antibody of patients under hemodialysis is compared to that of healthy population.


Eligibility Criteria:
Inclusion Criteria:

* The person who is vaccinated with ChAdOx1 (COVID-19 vaccine)
* The person who agrees with the protocol of the study

Exclusion Criteria:

* Age \< 18 years
* Pregnants
* Experience of COVID-19 infection
Description of the Psychiatric Care Pathway of Pregnant Women After the Early Prenatal Interview

Pregnancy and postpartum are recognized as periods of psychic fragility. However, the psychiatric disorders of women that can emerge during these periods are underdiagnosed and have consequences in particular on the development of the child, his relationship with his parents.

The need for an early diagnosis to allow appropriate treatment seems to be essential.

The pregnancy monitoring is centered on the somatic and little on psychological evaluation of the mother and the father.

In this context, the Early Prenatal Interview (EPP) was created through the perinatal plan of 2005-2007 in order to allow a more precise research of the factors of vulnerabilities likely to be predictive of a somatic, psychological or social disorder.

However, until now, only few pregnant women benefited of this interview. In May 2020, EPP became mandatory for all pregnant women. It now seems important to clearly identify the place, function, organization and usefulness of this interview in order to maximize its benefit in the monitoring of pregnancy

First, the investigators will describe the care pathway for pregnant women who have benefited of an early prenatal interview (EPP) between March 2019 and March 2020, namely continued classic follow-up or referral to a child psychiatrist / psychiatrist.

Then, the investigators will define two subgroups within the women oriented towards psychiatric follow-up: those who had this follow-up and those who did not.

Then, the investigators will identify the factors of failure of this referral to psychiatric follow-up and describe the eventual difficulties encountered by the lack of this follow-up.

Finally, the investigators will try to study these observations made with the perspective of maximizing the benefit of the Early Prenatal Interview in the monitoring of pregnancy.

Eligibility Criteria:
Inclusion criteria:

* No opposition from women to participate in the study
* Women over 18
* Women who had an EPP at Montpellier University Hospital between March 2019 and March 2020

Exclusion criteria:

- age \< 18 years
Decompression Versus Decompression and Fusion

Adjacent segment disease (ASD) in the lumbar spine is a well-known sequela of lumbar fusion surgery. The annual incidence of adjacent level re-operation is approximately 3% with a ten-year prevalence of 20-30%. Frequently, the surgical treatment involves decompression of the adjacent level coupled with extension of the instrumentation and fusion. Advocates of this paradigm cite the altered kinematics and biomechanics of levels adjacent to a lumbar fusion mass. Furthermore, decompressed levels adjacent to a fused segments are associated with higher rates of ASD in retrospective studies. Yet, a retrospective review of higher quality data concluded decompression adjacent to single-level fusion provides similar outcomes compared to fusions extending across the decompressed segments.

Given the conflicting data currently available, higher quality data are needed to guide surgical decision-making in ASD. The purpose of this trial is to prospectively compare decompression and decompression with fusion in patients with lumbar ASD.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients at least one year removed from a previous instrumented posterior lumbar fusion
* Patients with any prior posterior fusion involving L2 to the sacrum, whether single-level or multilevel
* Patients with symptoms related to central and lateral recess at the supradjacent level that have persisted despite at least six weeks of non-operative therapy modalities

Exclusion Criteria:

* Patients with previous uninstrumented lumbar fusions
* Patients with traumatic, neoplastic, or infectious etiologies at the adjacent segment
* Patients with prior iliac or sacroiliac fixation and those with nonunion as the primary indication for surgery
* Patients with pre-existing instability at the supradjacent level. The definition of instability will be determined based on standing lateral, flexion and extension plain radiographs. Patients with \>3mm of change between these views will be excluded.
* Retrolisthesis will not be a criterion for exclusion
Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Solid Cancer

This study is being performed to evaluate the safety and tolerability of the TRC105 monoclonal antibody.

In addition to safety, this study will also evaluate pharmacokinetics, tumor response and anti-TRC105 antibody formation.

Eligibility Criteria:
Inclusion Criteria:

* The patient has given informed consent.
* The patient is willing and able to abide by the protocol.
* The patient has cancer and curative therapy is unavailable.
* The patient is at least 18 years old.
* The patient has adequate ability to perform activities of daily living.
* Significant toxicities from prior therapy must have recovered.
* The patient has adequate organ function as assessed by laboratory test.

Exclusion Criteria:

* The patient weighs more than 264 lbs.
* The patient has a known allergy to gentamicin
* The patient has had prior treatment with high-dose chemotherapy requiring stem cell rescue
* The patient is currently on treatment on another therapeutic clinical trial or has received an investigational agent within 4 weeks prior to first dose with study drug
* The patient has had prior surgery (including open biopsy), radiation therapy or systemic therapy within 4 weeks of starting the study treatment
* The patient has hypertension \> 160/90
* The patient has a history of CNS cancer
* The patient has an unstable medical condition including, but not limited to, cardiac disease, history of stroke, active hepatitis, or significant pericardial, pleural or peritoneal effusion
* The patient received recent thrombolytic or anticoagulant therapy
* The patient has lung cancer with central chest lesions
* The patient has had hemorrhage or unhealed wounds within 30 days of dosing
* The patient has used systemic corticosteroids within 3 months of dosing
* The patient has known HIV/AIDS
* The patient has a history of hypersensitivity reaction to human or mouse antibody products
* The patient is pregnant or breastfeeding.
* The patient has a history of peptic ulcer disease or gastritis within 6 months of dosing, unless complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 30 days of dosing
Covid-19 In Tunisia: An Observational Cross-Sectional Registry Study

Covid-19 In Tunisia: AN Observational Cross-Sectional Registry Study


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 (+), inpatient or outpatient, confirmed by PCR test
* COVID-19 (-) confirmed by PCR test having been in contact with COVID-19 (+)

Exclusion Criteria:

* COVID(+) and COVID(-) diagnosed by other tests than PCR
* COVID-19 (-) Not having been in contact with COVID19(+)
Single-Session Web-Based Training in Self-Compassion

Two-arm, parallel group randomized clinical trial conducted via Mturk comparing a single-session web-based intervention called Compassionate Care versus a control intervention (nature videos with relaxing music) for adults with moderate-to-severe stress, depression and/or anxiety symptoms.

Procedures include completing: (1) pre-intervention baseline assessment; (2) one of two single-session web-based intervention (approximately 30 to 45 minutes each); (3) a brief post-intervention survey; and (4) a 2-week follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Fluent in English
* At least moderate stress, anxiety and/or depressive symptoms, as indicated by a score of:

  14 or higher on the PSS-10, and/or 10 or higher on the GAD-7, and/or 10 or higher on the PHQ-9

Exclusion Criteria:

* Fail to meet above-listed inclusion criteria
* Do not pass attention/data quality checks in initial screening or study assessments, including:
* Obvious lack of English fluency in open response questions
* Responding with random text in open response questions
* Respond with either copy/pasted responses from text earlier in the intervention to any of free response questions
* Participants with a completion time less than an average of 1.5 seconds per question for the baseline survey assessment OR who fail all three attention check questions in the baseline survey, indicating very careless, random, inattentive and/or hasty responding
* Exit the study prior to condition randomization
Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection

This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Rebetol® capsules (ribavirin, REB) will evaluate the safety and efficacy of SOF administered in combination with ribavirin under real world use in Japan. Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and treated with SOF+ribavirin in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.


Eligibility Criteria:
Key Inclusion Criteria:

* Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis
* Patients who are prescribed SOF+REB

Key Exclusion Criteria:

* None

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Psychopharmacotherapy for Depressive Patients

The primary purpose of this study is to compare the short (12 week) and long-term (1-year) efficacy and the tolerability between stepwise psychopharmacotherapy and antidepressant monotherapy for 12 weeks in adult patients with major depressive disorders, stratified by the multimodal serum biomarker scores.

This is prospective randomized controlled trials (RCT) to evaluate clinical impact of antidepressant monotherapy vs stepwise psychopharmacotherapy in patients with major depressive disorders, stratified by multimodal serum biomarker scores. Participants will be predicted treatment response based on the multimodal serum biomarker scores at baseline, will be categorized into good and poor treatment responders and then randomly assigned to two groups: stepwise pharmacotherapy group and antidepressant monotherapy group. The hypothesis is that in the good treatment responder, the depression remission will be achieved irrespective of treatment modality (stepwise pharmacotherapy or antidepressant monotherapy) group while in poor treatment responders, the treatment response of stepwise pharmacotherapy will be superior to those of antidepressant monotherapy.

Eligibility Criteria:
Inclusion Criteria:

* 19 to 65 years
* Diagnostic and Statistical Manual of Mental Disorders-IV criteria for major depressive disorder by study psychiatrists
* Score≥17 on Hamilton Depression Rating Scale-17
* With ability to understand the objective of the study and sign informed consent
* Initiation of an antidepressant treatment for the current episode or no psychotropics excluding sleep pills or benzodiazepines within 1 month of participation

Exclusion Criteria:

* Current or lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified, or other psychotic disorders
* current major depressive disorder with psychotic features
* History of organic psychosis, epilepsy, or seizure disorder
* Current anorexia nervosa or obsessive compulsive disorder
* Unstable or uncontrolled medical condition
* Unable to complete the psychiatric assessment or comply with the medication regimen due to a severe physical illness
* History of anticonvulsant treatment
* Electroconvulsive therapy for the current depressive episode
* Hospitalization for any psychiatric diagnosis except depressive disorder (e.g., alcohol/drug dependence)
* severly high risk of suicide, self-harm or homicide by investigator's assessment
* Pregnant or breastfeeding
* lack of treatment information on the current depressive episode