cyrilzakka/clinical-trials huggingface dataset:
Task Shifting to Treat Depression and HIV Medication Nonadherence in Low Resource Settings

A hybrid effectiveness-efficacy trial to evaluate a stepped care task shifted intervention to treat depression and HIV medication nonadherence in low resource settings in rural Zimbabwe.

Depression is commonly co-morbid with HIV infection in Zimbabwe and is consistently associated with worse adherence to antiretroviral therapy (ART). A task-shifted intervention for depression and ART adherence, suitable for delivery by non-specialists, could make a critical difference to the health and survival of people managing the challenges of HIV treatment in Zimbabwe. The TENDAI trial is a two-arm randomized controlled trial of an intervention for people on ART with viral non-suppression and clinically significant depression. It will be delivered at an HIV clinic in Marondera. TENDAI is a collaboration between the Department of Psychiatry, University of Zimbabwe College of Health Sciences, King's College London Institute of Psychiatry, Psychology and Neuroscience (London UK), and the Department of Psychiatry at Massachusetts General Hospital / Harvard Medical School.

Eligibility Criteria:
Inclusion Criteria:

* Initiated on ART for at least 6 months
* Clinically significant depression symptoms scoring \>/= 10 on the Patient Health Questionnaire-9
* Viral non-suppression in past two months per local clinic standard (VL \> 1000 copies/mL)
* Able to provide informed consent
* If prescribed antidepressants, on stable regimen for at least 2 months

Exclusion Criteria:

* Unable to provide informed consent
* Active major mental illness (e.g. untreated psychosis or mania, actively suicidal), major untreated or undertreated mental illness or advanced physical disease or severe cognitive impairment assessed using the psychosis module of the MINI, the PHQ-9, and the International HIV dementia Scale which would interfere with engagement in PST-AD
* Has ever received PST or CBT for depression
* Less than 18 years of age
Ultra-High-Resolution Mapping Guided Partial Antral Ablation for AF

The electrical isolation of the pulmonary veins (PVI) is the cornerstone of current ablation techniques for the treatment of atrial fibrillation (AF) because the PV is the most common trigger of AF. Wide bi-antral circumferential ablation (WACA) is more effective than segmental PV isolation in achieving freedom from total atrial tachyarrhythmia recurrence at long-term follow-up. Therefore, it is widely accepted as initial ablation strategy. However, the WACA technique requires a much larger number of ablation and higher energy to achieve complete isolation because of thick atrial myocardial sleeves with multiple muscle layers present in most of the PV antrum, which is less likely to achieve homogenous transmural lesions in the entire circumference with the currently available ablation technologies. Meanwhile, muscular discontinuities and abrupt changes of the fiber orientation in human PV-Left atrium (LA) junction are previously reported, and electrical PV isolation can usually be achieved without complete circumferential ablation. However, the current electroanatomical mapping (EAM) system has a limitation to understand the complex relationship of PV-LA junction mainly due to relatively low resolution.

The Rhythmia mapping system (BostonScientific, Inc, Cambridge, MA) is a new system provides ultra-high-resolution EAM using a small basket array of 64 electrodes (IntellaMap Orion, Boston Scientific). Owing to better resolution, this new system capable of rapidly and accurately identify critical isthmuses and low-voltage regions of interest and also allows automatic acquisition and accurate annotation of the electrograms, without the need for manual correction.

In this context, we hypothesized that rapid and precise identification of activation pattern of PV-LA junction by Rhythmia system could allow complete, durable electrical isolation of PVs without circumferential antral ablation.


Eligibility Criteria:
Inclusion Criteria:

1. Age over 20 years old and under 80 years old
2. Patients with non-valvular paroxysmal atrial fibrillation
3. Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks
4. Patients who could have informed consent
5. Patients who are available for a follow-up of more than at least three months after the catheter ablation

Exclusion Criteria:

1. Patients unsuitable for catheter ablation due to a previous history of pulmonary surgery or structural heart disease
2. Patients who cannot receive standard treatments such as anticoagulation therapy needed before the radiofrequency catheter ablation
3. Patients in the subject group vulnerable to a clinical study
4. Patients who had undergone a prior catheter ablation for atrial fibrillation
Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.

Bronchiolitis in infants and young children often requires respiraty support. In Denmark Continous Positive Airway Pressure ( CPAP) are routinely used in children with moderate-severe bronchiolitis. The aim of the study is to compare CPAP and High Flow Oxygenation Therapy (HFOT) as tools of respiratory support in infants and young children with bronchiolitis.

Infants and young children with moderate-severe bronchiolitis and are randomized to either CPAP or HFOT.


Eligibility Criteria:
Inclusion Criteria:

* infants and children with moderate respiratoric syncytial virus bronchiolitis or other viral bronchiolitis and need of respiratory support. ( clinical decision)

Exclusion Criteria:

* severe bronchiolitis with P C02 \> 9, decreased consciusness and risk for early progression to intensive therapy.
Precision Diagnosis for Intraoperative Frozen Section of Early Stage Lung Cancer

The purpose of this study is:

1. To establish a set of diagnostic criteria of intraoperative frozen section of early stage lung adenocarcinoma, including clinicopathologic and molecular characteristics.
2. To assess its clinical usefulness in guiding surgical procedure for early stage lung adenocarcinoma.

The detection rate of small pulmonary nodules is increasing due to the widespread use of high-resolution computed tomography (CT) screening in clinical practice. These minute pulmonary nodules are suggestive of atypical adenomatous hyperplasia (AHH), adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA), and invasive adenocarcinoma. Hence, the precision diagnosis of intraoperative frozen section is particularly imperative for its fundamental role in assess indeterminate lung lesions and guide the extent of subsequent surgical procedure.

However, it is still difficult for the surgical pathologist to apply the various features according to the newly revised WHO classification of lung adenocarcinoma (2015) to guide surgical management due to their unascertained accuracy or heterogeneity of lung cancer or technique problem. Therefore, the establishment and assessment for a set of diagnostic criteria of intraoperative frozen section of early stage lung adenocarcinoma are our primary aim in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with suspected pulmonary nodules (5\~20 mm) by chest CT scan;
2. Patients received surgical operation.

Exclusion Criteria:

1. Patients compliance is poor and cannot accept follow-up;
2. Patients nursing or pregnant;
3. Patients with a history of any cancer;
4. Patients with confirmed pathological diagnosis or received radiotherapy or chemotherapy or target therapy preoperatively.
Chorioamnionitis and Proinflammatory S100A12

Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS) and increased levels of proinflammatory molecules.

Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS). The aim of this pilot study was to evaluate S100A12, a marker of innate immune activation, in mothers with or without HCA and in their infants.

Concentrations of S100A12, Interleukin 6 (IL-6) and C-reactive protein (CRP) were evaluated in maternal, cord, and neonatal blood of very preterm infants. Histologic examinations of placentae and umbilical cords were performed.

Eligibility Criteria:
Inclusion Criteria:

Preterm Birth

Exclusion Criteria:

Congenital Abnormalities
Development of a Family-Based Transition Planning Program for Culturally-Diverse Youth on the Autism Spectrum

The goal of this clinical study is to develop a community-based program to support family members of transition-aged youth on the autism spectrum to help them plan for the future. The main aims of the study are:

1. To develop the Families FORWARD program
2. To conduct proof-of-concept testing of the Families FORWARD program

Participants will complete surveys before and after participating in the program and will participate in exit interviews at the end of the program.

The Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD) program aims to increase family members' active planning for the transition to adulthood in the context of autism. The program is designed to enable flexible delivery for families of youth who are diverse across autism features, co-occurring conditions, service needs, cultural values and preferences, and readiness to engage in planning. The program will be delivered collaboratively with community organizations that support individuals on the autism spectrum and/or their families.

The current project aims to conduct proof-of-concept testing with a culturally-diverse sample of families of transition-aged youth on the autism spectrum. Parents / primary caregivers will participate in 6-7 individual, personalized sessions that incorporate aspects of skill-building (communication, goal-setting, problem-solving, systems navigation), education about services, and motivational interviewing. Youth will be invited to participate in 3 of the sessions along with their parent / primary caregiver. Participants will complete surveys before and after participating in the program and will participate in exit interviews at the end of the program. The investigators will assess indicators of acceptability, feasibility, and improvement on proposed mediators and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Family Inclusion Criteria

  1. Parents or primary caregivers of transition-aged youth on the autism spectrum:

     1. Have one or more child(ren) on the autism spectrum who is/are ages 14-21 years old
     2. Identify as the parent, legal guardian, and/or primary caregiver of the youth
     3. Speak English fluently
     4. Reside in Massachusetts
  2. Youth on the autism spectrum:

     1. Have an autism diagnosis OR identify as autistic
     2. Age 14-21
     3. Have ability to communicate verbally or in written format in English
     4. Reside in Massachusetts

Exclusion Criteria: none
Mechanisms of Change in Brief Treatment for Borderline Personality Disorder

The present two-arm randomized controlled study aims at testing the effects (i.e., symptom reduction) and the underlying mechanisms of change associated with a brief psychiatric treatment (10 sessions over 4 months), compared with treatment as usual. Participants undergo assessments at four points (intake, 2 months, discharge and 12 month follow-up). In addition to symptom measures, all individuals undergo a two-step assessment for the potential mechanisms of change (i.e., emotion and socio-cognitive processing): a) behavioural and b) neurofunctional. We hypothesize that change in the mechanisms explains the treatment effects. The present study uses an innovative treatment of BPD and at the same time a sophisticated assessment procedure to demonstrate the critical role of psychobiological change in emotion and sociocognitive processing in brief treatments. It will help increase the effectiveness of initial treatment phase for BPD and help diminish the societal burden of disease related with BPD. This study is funded by the Swiss National Science Foundation (SNSF).


Eligibility Criteria:
Inclusion Criteria:

* Borderline Personality Disorder
* age between 18 and 35

Exclusion Criteria:

* non-mastery in French
* neurological disorders
* schizophrenia (according to DSM-5)
Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.

This study will look at the change in body weight in people taking NNC0174-0833, liraglutide and "dummy" medicine, from the start to the end of the study. As well as taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either take NNC0174-0833, liraglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take one injection once a week or once a day, depending on the treatment. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 8 months. Participants will have 12 clinic visits with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older at the time of signing the informed consent.
* Female subject of non-childbearing potential or Male subject who is surgically sterilised (vasectomy) or who is willing to use adequate contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').
* BMI equal to 30.0 kg/m\^2 or greater or BMI equal to 27.0 kg/m\^2 or greater with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension or dyslipidaemia (to be assessed at the investigator's discretion).

Exclusion Criteria:

* HbA1c equal to 48 mmol/mol (6.5 percentage) or greater as measured by the central laboratory at screening.
* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening irrespective of medical records.
Changes in Cellular Immune Profile During COVID-19 Infection

Clinical specimens are collected from individuals either recovered from or with active SARS-CoV-2 infection to support process and analytical development for a potential cell-based immunotherapy in preclinical research, SRPH-CVD-01.

SRPH-CVD-01 is an allogeneic cell-based immunotherapy candidate to be investigated in a subsequent clinical trial under a future FDA IND to treat people suffering from COVID-19.

Enrolled participants provide a venous blood specimen (up to 40mL) to be used in preclinical studies and research and development of SRPH-CVD-01. Subjects may eventually be asked to undergo leukapheresis for peripheral blood mononuclear cell (PBMC) collection and their specimens will be used to further develop the SRPH-CVD-01 cell product, including a cGMP compliant process to be applied under the future FDA IND.

This protocol is to collect blood and PBMC specimens from individuals with active of past COVID-19 infection. The first blood draw will be done at the first study visit and if eligible, the second collection will be done via leukapheresis at the second visit. The leukapheresis procedures will follow the facility's standard operating procedures and protocol requirements for leukapheresis.

Donors will be males or females between and including the ages of 18 years and 60 years. Volunteers will provide written informed consent and meet all inclusion and exclusion criteria. Each participant can be in the study for up to 180 days (6 months).

The study will be conducted in accordance with human research for the purposes of obtaining clinical specimens for research. There is no endpoint for this study, however, data collected from this study will include, but not be limited to, gender, demographics, medical history, clinical laboratory values, and volume of the blood collected. The data will be summarized in future studies reporting results from a future clinical trial under FDA IND.

Eligibility Criteria:
Inclusion Criteria:

* Male of female aged 18-60
* Documented current or past (max 3 months prior) diagnosis of COVID19
* Participants who has not participated in a cell or gene therapy trial for COVID19

Exclusion Criteria:

* Uncontrolled SARS symptoms
* Oxygen saturation (Pulse Ox) \< 90%
* Uncontrolled diabetes
* Uncontrolled hypertension
* Active DIC, bleeding or coagulopathy which cannot be corrected with minimal intervention
* Symptomatic, uncontrolled or severe intercurrent illness that would compromise the ability to tolerate blood collection or leukapheresis procedure
* Systemic chemotherapy less than or equal to 2 weeks (6 weeks for clofarabine or nitrosoureas) or radiation therapy less than or equal to 3 weeks prior to leukapheresis
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test at screening
* Any patient that in the opinion of the investigator is not medically stable to undergo the leukapheresis procedure or will not comply with the visit schedules or procedures
A Cohort Study on Anti-microbial Stewardship in PICU

Appropriate antimicrobial therapy is essential to ensuring positive patient outcomes. Inappropriate or suboptimal utilization of antibiotics can lead to increased length of stay, multidrug-resistant infections, and mortality. Critically ill intensive care patients are at risk of antibiotic failure and secondary infections associated with incorrect antibiotic use. Initiating effective therapy for infections based upon patients' risk factors, collection of appropriate cultures, daily evaluation of clinical status, and laboratory data, including antibiotic time outs, and shortened duration of therapy are ways to improve patients outcomes. Antimicrobial stewardship teams can assist ICU providers in managing and implementing these tactics. ICUs would benefit from employing empiric guidelines for antibiotic use, collecting appropriate specimens and implementing molecular diagnostics, optimizing the dosing of antibiotics, and reducing the duration of total therapy.

Appropriate antimicrobial therapy is essential to ensuring positive patient outcomes. Inappropriate or suboptimal utilization of antibiotics can lead to increased length of stay, multidrug-resistant infections, and mortality. Critically ill intensive care patients are at risk of antibiotic failure and secondary infections associated with incorrect antibiotic use. Initiating effective therapy for infections based upon patients' risk factors, collection of appropriate cultures, daily evaluation of clinical status, and laboratory data, including antibiotic time outs, and shortened duration of therapy are ways to improve patients outcomes. Antimicrobial stewardship teams can assist ICU providers in managing and implementing these tactics. ICUs would benefit from employing empiric guidelines for antibiotic use, collecting appropriate specimens and implementing molecular diagnostics, optimizing the dosing of antibiotics, and reducing the duration of total therapy. This study conducted an antibiotic management cohort study in PICUs to discover the distribution of nosocomial infections in PICUs and to find controllable factors for the occurrence of nosocomial infections.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU for more than 48 hour

Exclusion Criteria:

* Patients admitted to ICU less than 48 hours
Early Use of TIPS With Polytetrafluoroethylene(PTFE) Covered Stents in Cirrhotic Patients With Refractory Ascites

This multicenter RCT is designed to investigate if TIPS with covered stents improves transplant-free survival for cirrhotic patients with early stage of refractory ascites compared to LVP+albumin during 1 year follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of liver cirrhosis
* Recurrent and refractory ascites
* Patients with an age between 18 and 65 years old
* Child-Pugh ≤12
* Absence of hepatic encephalopathy
* Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.
* Patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study

Exclusion Criteria:

* With more than 6 paracenteses within the last 3 months
* patients expected to receive transplants within the next 6 months or on waiting list
* Usual contra-indication for TIPS: congestive heart failure NYHA\>III or medical history of pulmonary hypertension, portal vein thrombosis（\>50%）, hepatic polycystosis, intra-hepatic bile ducts dilatation
* Patient has had previous TIPS placement
* Severe liver dysfunction by: Prothrombin index \< 40% or total bilirubin \> 50μmol/l
* Serum creatinine \>133μmol/l
* Severe hyponatremia \<125mmol / L
* Uncontrolled sepsis
* Gastrointestinal hemorrhage within 6 weeks of randomization
* Known allergy to albumin
* Pregnant or breast feeding women
* Refusal to participate or patient unable to receive informations or to sign written informed consent
Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

The purpose of the ALLO-605-201 study is to assess the safety, efficacy, and cell kinetics of ALLO605 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of relapsed/refractory multiple myeloma (MM)
* Subjects must have measurable disease
* Subjects must have received ≥3 prior MM lines of therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic, renal, liver, pulmonary, and cardiac functions
* Life expectancy of at least 3 months without treatment

Exclusion Criteria:

* Subjects with known active or history of central nervous system (CNS) or leptomeningeal involvement of myeloma or plasma cell leukemia
* Current or history of thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy
* Autologous stem cell transplantation within last 6 weeks prior to the start of lymphodepletion
* Any prior allogeneic hematopoietic stem cell transplantation
* Systemic anti-cancer therapy within 2 weeks prior to the start of lymphodepletion