cyrilzakka/clinical-trials huggingface dataset:
Initial Testing of Whole Health STEPS

This clinical trial is evaluating Whole Health STEPS (Structured Tiered Engagement with Peer Support), a package of services designed to improve functional outcomes for primary care Veterans with mental health concerns who are not actively engaged in mental health services. Whole Health STEPS uses a Peer Support Specialist, or Peer, to provide support for Veterans to make progress on wellness goals using the Whole Health model. The level of support provided will be determined based on Veterans' progress and will be stepped-up until Veterans receive the level of support they need. Whole Health STEPS offers a non-mental health referral option for primary care Veterans with mental health concerns, provides a structured package of existing Whole Health services, and provides a structured service for peers in primary care settings.


Eligibility Criteria:
Inclusion Criteria:

* Veteran status
* Enrolled in primary care at a participating site
* Have at least mild functional impairment
* Screen positive on at least one primary care mental health screener

Exclusion Criteria:

* Actively engaged with an equivalent or higher level of care
* Preference for direct referral to mental health care
* Recent changes to psychotropic medications
* Severe impairment preventing engagement in the intervention or warranting a direct referral to a licensed independent provider
* Inability to independently communicate in verbal and written English
* Inability to complete the research tasks or intervention
Metagenomic Analysis of Human Gut Microbiota in Patients With Metabolic Diseases Including Diabetes

Microbiota is important for immunology, hormonal and metabolic homeostasis in human and could influence on developing diabetes and obesity. Recent studies investigates microbiota by metagenomic sequencing, however, the composite of microbiota and its metabolic role has not been fully determined. Metagenomics and microbiome analysis could early diagnose metabolic disorders and suggest treatment options for metabolic diseases.

In this study, the investigators investigate the composite of microbiota and deduct basic information for treatment models using metagenomic sequencing.

1. Cross-section study: normal/prediabetes/drug naïve type2 diabetes: compare microbiota using metagenomic sequencing among three groups.
2. Observational prospective study: metformin/sodium glucose co-transporter 2 (SGLT2) inhibitor/ezetimibe: compare microbiota using metagenomic sequencing before and after drug treatment.

Eligibility Criteria:
Inclusion Criteria:

* normal group: body mass index \[BMI\]\<23kg/m2, without diabetes mellitus history
* prediabetes group: fasting blood glucose ≥100 mg/dL and \<126 mg/dL or postprandial blood glucose ≥140 mg/dL and \<200 mg/dL
* type 2 diabetes according to ADA(American Diabetes Association) guideline (1) fasting blood glucose ≥126 mg/dL, (2) random blood glucose ≥200 mg/dL and with typical diabetes symptoms, (3) glycated hemoglobin A1c ≥6.5% and anti-hypoglycemic drug naive
* patients with type 2 diabetes, metformin monotherapy, SGLT2 inhibitor monotherapy
* patients with dyslipidemia, ezetimibe therapy

Exclusion Criteria:

* inflammatory bowel disease (Crohn's disease, ulcerative colitis)
* history of stomach, small intestine or colon resection operation
* on antibiotics therapy
Knee Replacement and Sarcopenia

The presence of sarcopenia in patients planned to undergo knee prosthesis and the effect of knee prosthesis on sarcopenia will be investigated

Volunteer patients who will undergo knee replacement surgery in orthopedic clinics located in the Istanbul region and who meet the inclusion criteria will be recruited. A total of 31 volunteers will be included in the study.

First, all patients will be asked about their gender, age, height, weight, education, smoking, lifestyle, additional diseases, and treatments they have received. Then, a brief orthopedic evaluation will be performed on the patient. TANITA BIA analysis and grip strength measurement from the dominant hand will be performed on all patients before the operation, at 1 month and 3 months after the operation. Maximal voluntary grip strength will be measured with a hand dynamometer. Measurements will be made three times. For this measurement, the subject will be asked to hold a maximal voluntary grip for five seconds. There will be a ten-second rest period between the three tests. Measurements will be made with the JAMAR Plus+ (by Sammons Preston) hand dynamometry device. Before the test measurements, the patient will be shown how to use the device as an application. The highest of the three measured values will be taken. In addition, the calf circumference will be measured. While the patient is standing, the measurement will be made with a tape measure from the thickest point of the right and left calves without squeezing the skin. The same measurement will be repeated with the patient seated. At the same time, patients will be evaluated with walking speed test, sit-to-stand test, SARC-F, FRAIL Frailty Questionnaire, Mini Nutritional Assessment, EQ-5D General Quality of Life Scale, GLIM Test, Barthel Activities of Daily Living Index, CIRS Scale before the operation, 1st month and 3rd month after the operation.

When performing the walking speed test, the patient will be asked to walk as they normally do. A 4-meter or 3-meter walking speed test will be performed and a single test will be scored. Measurements will be made twice and the fastest will be evaluated.

In the sit-to-stand test, the person will be asked to try to get up without using their arms. If they cannot complete the test or can get up using their arms, the patient will receive 0 (zero) points. If they can get up using their arms, the repeated sit-to-stand test will be performed. In the repeated sit-to-stand test, the person will be asked to sit down and get up from a chair 5 times in a row without using their arms. Scoring will be between 0-4 depending on the time spent.

Eligibility Criteria:
Inclusion Criteria:

* Being between 50-75 years old
* Undergoing knee arthroplasty surgery
* Patients who agreed to participate in the study and gave written consent

Exclusion Criteria:

* Having a history of malignancy
* Being under 50 and over 75 years old
* Having one of the muscle/nerve diseases
Prognostic Impact of Noncardiac Comorbidities in Heart Failure Patients

To better understand the public health prognostic impact of noncardiac chronic illnesses, we explored the attributable risk of noncardiac comorbidities on outcomes between heart failure patients with reduced ejection fraction (HFREF) and heart failure patients with preserved ejection fraction (HFpEF) in a large contemporary heart failure (HF) population The adjusted hazard ratio (HR) and the population attributable risk were used to compare the contributions of 15 noncardiac comorbidities to adverse outcome. The comorbidities that contributed to high attributable risk were: anemia, chronic kidney disease, chronic obstructive pulmonary disease, diabetes mellitus, and peripheral artery disease. These findings were similar for HFrEF and HFpEF groups. Interaction analysis confirmed similar results.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive heart failure patients with left ventricular ejction fraction available before or within 3 months from the index visit

Exclusion Criteria:

* We excluded all patients who had severe primary left-sided valvular disease
Efficacy of HIPEC in the Treatment of Patients With Locally Advanced Gastric Cancer

The purpose of this study is to study the efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of patients with locally advanced gastric cancer after radical gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.


Eligibility Criteria:
Inclusion Criteria:

* 18 \< age ≤ 65 years old
* Male or Non pregnant female
* The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
* Histologically diagnosed as T4 gastric adenocarcinoma (determined from data obtained by endoscopic ultrasound or CT scan)
* Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy
* White blood cells \> 4,000/mm3
* neutrophils ≥ 1,500/mm3
* platelets ≥ 100,000/mm3
* hemoglobin\>9g/l
* Alanine transaminase (ALT) and aspartate aminotransferase (AST) \< or = 2.5 times upper limit of nominal (ULN)
* total bilirubin (TBIL) \< 1.5 times ULN
* serum creatinine \< 1 times ULN
* Having given written informed consent prior to any procedure related to the study

Exclusion Criteria:

* Existence of macroscopic peritoneal implants
* Prior malignant tumors with detectable signs of recurrence or distant metastasis
* Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\<50%
* Receiving other cytotoxic chemotherapy
* High grade of intra-abdominal adhesions
* Contraindication to any therapy contained in this regimen specific to the study Without given written informed consent
Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment

The purpose of this study is to look at the safety and effectiveness of an experimental protease inhibitor (a type of anti-HIV drug) called BMS-232632. Doctors will compare an anti-HIV drug combination that includes BMS-232632 to a drug combination that includes ritonavir.

This is a three-arm study; patients are randomized to receive BMS-232632 at two different doses or RTV in combination with SQV and two nucleoside analogues over 48 weeks. Randomization is stratified for baseline phenotypic sensitivity.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a viral load (level of HIV in the blood) of at least 2,000 copies/ml.
* Have a CD4 count of at least 100 cells/mm3 (or at least 75 cells/mm3 in patients who have never had an AIDS-defining illness).
* Are currently receiving an anti-HIV drug combination that includes a protease inhibitor or nonnucleoside reverse transcriptase inhibitor (NNRTI), and they have been taking this drug combination for at least 24 weeks. They must have responded well to this treatment at first (their viral load decreased) but are currently experiencing an increase in viral load.
* Will most likely respond well to the study drugs, as shown by the results of a lab test.
* Are at least 18 years old.
* Agree to use effective barrier methods of birth control (such as condoms).
* Are available for follow-up for at least 48 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have a newly diagnosed opportunistic (HIV-related) infection requiring treatment.
* Have only recently become HIV positive.
* Abuse alcohol or drugs.
* Have severe diarrhea within 30 days of study entry.
* Have hemophilia.
* Have a history of pancreatitis.
* Have hepatitis within 30 days of study entry.
* Have peripheral neuropathy (a painful condition affecting the nervous system).
* Are unable to take medications by mouth.
* Are pregnant or breast-feeding.
Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma

RATIONALE: Drugs used in chemotherapy, such as temozolomide, 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 temozolomide works in treating patients with recurrent glioblastoma multiforme or other malignant glioma.

OBJECTIVES:

Primary

* Determine the progression-free survival rate at 6 months in patients with recurrent glioblastoma multiforme or other malignant glioma treated with temozolomide.

Secondary

* Determine the overall survival of patients treated with this drug.

OUTLINE: Patients receive oral temozolomide once daily in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and every 2 months for 2 years for evaluation of markers of neo-angiogenesis. Samples are analyzed by protein expression, reverse-transcriptase PCR, ELISA, and western blot. (Samples are no longer being collected and tested as of 1/12/09)

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Pathologically diagnosed glioblastoma multiforme or other malignant glioma

  * Recurrent disease
* Must have received prior temozolomide

PATIENT CHARACTERISTICS:

* Karnofsky performance status 60-100%
* Granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* SGOT ≤ 2.5 times upper limit of normal (ULN)
* Creatinine ≤ 2 times ULN
* Bilirubin ≤ 2 times ULN
* No other active malignancy except for cervical carcinoma in situ or basal cell carcinoma of the skin
* No serious medical or psychiatric illness that, in the opinion of the investigator, would preclude study treatment
* No medical condition that precludes swallowing pills
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Recovered from all prior therapy
Drug Utilization and Safety Events Among Children Using Esomeprazole, Other Proton Pump Inhibitors or H2-receptor Antagonists

The purpose of this study is

1. To describe patient characteristics and drug usage among children that are prescribed esomeprazole for the first time and to compare them with patients who are prescribed other proton pump inhibitors (PPIs) or H2-receptor antagonists for the first time.
2. To ascertain all incident hospitalized cases of angioneurotic oedema, pneumonia, gastroenteritis, failure to thrive, convulsions/seizures, acute interstitial nephritis and thrombocytopenia among new users in the three cohorts of esomeprazole, other PPIs and H2-receptor antagonists.

Time Perspective: Other = Retrospective analysis of prospectively collected data Number of Anticipated Subjects: All subjects dispensed esomeprazole, other PPIs or H2-receptor antagonists for the first time during the study period

Eligibility Criteria:
Inclusion Criteria:

* Age 0-18 years
* Newly dispensed esomeprazole, other proton pump inhibitors or H2-receptor antagonists

Exclusion Criteria:

* Children with less than one year of history in PHARMO RLS before study cohort entry (if a child is \<1 year at cohort entry, history from birth is required)
* Children using more than 1 acid suppressing drug concomitantly at cohort entry
Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study

Children with malnutrition are often low in some nutrients, like zinc or vitamin A, that could help them fight off infections like pneumonia. Our study was designed to see if children who got supplements of zinc or vitamin A had fewer infections.

The Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) study was a multi-year nutritionally-stratified, placebo-controlled, double-blind study of low-dose vitamin A and/or zinc in 2,582 normal and malnourished urban children aged 6 to 36 months in Quito, Ecuador. Four group of \~ 645 children were enrolled in 2000, 2001, 2002, and 2003 with each child participating for up to 50 weeks. Children were visited 4 days each week. Outcome measures were pneumonia, other respiratory tract infections, diarrheal disease, and growth.

Eligibility Criteria:
Inclusion Criteria:

Age 6 to 36 months at the time of enrollment No recent vitamin or micronutrient use Residence of 1 year or longer in the neighborhood Full and free written consent No clinical evidence of zinc or vitamin A deficiency Absence of severe malnutrition such as weight \< or = to 60% of expected weight

-

Exclusion Criteria:

Age less than 6 months or greater than 36 months at enrollment Recent vitamin or micronutrient use Residence for less than 1 year in neighborhood Lack of full and free consent Any evidence of zinc or vitamin A deficiency Severe malnutrition
The Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection

The purpose of this study is to find a correlation between function of cytomegalovirus -specific T cells and the probability for intrauterine transmission.

Fetal infection with CMV is the most common cause of intrauterine infection. Only 40% of pregnant women with primary CMV transmit the virus to their fetus. Many of these women are referred to amniocentesis and many elect to terminate pregnancy without knowledge about fetal infection or damage. Currently it is assumed that transmission is dictated by variety of factors including maternal and fetal immune system. Efforts to find correlation between maternal immune system and fetal infection which can be used as a diagnostic marker were unsuccessful.

Our hypothesis is that there is a correlation between cellular immune response of the mother to CMV infection and viral transmission to the fetus.

Pregnant women with primary CMV infection (40% of whom are expected to be transmitters)and with pre-conception immunity will participate in this study.

Blood from these women will be incubated with CMV peptides and T cell activation will be measured by the secretion of various cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* CMV IgG sero-conversion or the presence of low avidity IgG antibodies or the presence of IgM with no previous IgG antibodies.

Exclusion Criteria:

* Underlying immune deficiencies
* Other pregnancy complications
Early Evaluation of Exosome Multiomics and Clinical Prognosis in Patients With Sudden Death

Acute coronary syndrome (ACS) is one of the main causes of death. Worldwide, tens of millions of patients are hospitalized for coronary heart disease and ACS every year. ACS may show acute myocardial infarction, unstable angina pectoris, and even induce early arrhythmia, leading to sudden death. Sudden cardiac death (SCD) has a strong correlation with ACS. Data from clinical and autopsy studies and death certificates show that 62-85% of patients with out of hospital SCD have a history of ACS, 10% have other cardiac structural abnormalities, and 5% have no cardiac structural abnormalities. An SCD surveillance study from Ireland concluded that most cases occurred in families, and the successful recovery of SCD was mainly related to ventricular fibrillation with arrhythmia. At present, there are few reports on the clinical and prognosis of ACS in China, and there is no guideline or consensus on the prevention and treatment of ACS patients. Known domestic research results show that the proportion of male, overweight / obese, smokers in young ACS patients is higher than that in the elderly group, while the proportion of patients with hypertension, diabetes and cerebrovascular diseases is less than that of the elderly group. The levels of TC, TG, LDL-C and UA and the proportion of low HDL-C in young ACS patients were higher than those in elderly patients; The diagnosis of STEMI was the highest in the young ACS group, while the diagnosis of unstable angina pectoris was the most common in the elderly ACS group. The clinical manifestations of ACS vary greatly. 3% \~ 5% of patients who exclude ACS only through myocardial markers, clinical blood transfusion and ECG still have myocardial infarction (MI). For the emergency department, early prediction of the risk of SCD in ACS patients and timely and accurate screening of high-risk patients are very important.


Eligibility Criteria:
Inclusion Criteria:

* The death event happens suddenly.
* Age ≥ 18 years
* The patient had obvious clinical symptoms 24 hours before treatment
* Life expectancy exceeds 3 days
* Proxy of patients signs the informed consent form
* Comply with ACS diagnostic indicators recommended by ACC / AHA guidelines in 2016

Exclusion Criteria:

* Death caused by accident, such as trauma, poisoning, etc.
* Death from accidental or intentional overdose
* Death from asphyxia
* Death is caused by chronic disease or terminal illness
* The patient died naturally
* Has participated in other clinical studies
* Immediate family members give up continuing treatment
Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome

The purpose of this study is to investigate if lymphocyte markers predict response to rituximab among patients with idiopathic nephrotic syndrome


Eligibility Criteria:
Inclusion Criteria:

* Age 1-18 years old at the time of diagnosis of nephrotic syndrome
* Steroid-dependent (SDNS) or steroid-resistant nephrotic syndrome (SDNS)

Exclusion Criteria:

* eGFR \<60 ml/min per 1.73m2
* infantile onset of nephrotic syndrome
* nephrotic syndrome secondary to chronic infections such as hepatitis B, hepatitis C or human immunodeficiency virus, systemic lupus erythematosus, Henoch-Schönlein purpura, IgA nephropathy, membranoproliferative glomerulonephritis or membranous nephropathy
* current or previous therapy for tuberculosis
* presence of mutations in WT1, NPHS1, NPHS2 and TRPC6.
TB-CAPT EXULTANT - HIV

The overall aim of this study is to assess the potential of an expanded TB testing strategy to increase the number of HIV-positive patients with microbiologically diagnosed TB who are started on treatment in adult wards of sub-Saharan Africa.

To investigate the effect of an expanded TB screening strategy among HIV-positive patients admitted to hospital (including Ultra on sputum, stool and urine, and AlereLAM on urine, performed regardless of presence of TB symptoms) on the proportion of microbiologically-confirmed TB cases starting treatment within 72 hours of enrolment, compared to Ultra testing (on sputum/any tissue) and AlereLAM (on urine) in only those patients who are symptomatic for TB or fulfilling WHO testing recommendations.

to assess the impact of this screening strategy on 2-month all-cause mortality.

• to assess the feasibility of multiple specimens' collection for TB diagnosis within 72 hours of enrolment.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (18 years old and above)
2. Confirmed HIV infection by serology (including both antiretroviral (ART)- naïve and experienced)
3. Admitted to the hospital (adult medical wards) at the time of enrolment.

Exclusion Criteria:

1. Unable to provide informed consent (if no authorized relatives are in the position to provide the consent)
2. Living outside the catchment area of the participating hospital(s)
3. with plans to migrate outside the catchment area within 2 months after recruitment.
4. Currently receiving anti-TB therapy or having received anti TB therapy in the last 6 months prior to enrolment
5. Receiving preventive TB treatment in the preceding 6 months
6. Patients admitted for traumatic reasons, acute abdomen, delivery (maternal conditions), or for planned/scheduled surgery.
7. Referred from other hospital.