cyrilzakka/clinical-trials huggingface dataset:
Real-time Intervention for Suicide Risk Reduction

The goal of this study is to provide an initial pilot test of an Ecological Momentary Intervention (EMI) designed the reduce the distress associated with negative emotion among individuals at risk for suicide that pairs content from a smartphone with a wearable physiological monitor. Participants will be 25 suicidal adult inpatients who will complete three brief therapy sessions with a study therapist and then complete exercises associated with the study for the duration of the inpatient period and for 28 days after they leave the hospital.

The goal of this study is to provide an initial pilot test of an Ecological Momentary Intervention (EMI) designed the reduce the distress associated with negative emotion among individuals at risk for suicide that pairs content from a smartphone with a wearable physiological monitor. Participants will be 25 suicidal adult inpatients who will complete three brief therapy sessions with a study therapist and then complete exercises associated with the study for the duration of the inpatient period and for 28 days after they leave the hospital. During the time they are in the study, participants will be asked to install on their smartphone a mobile application to deliver the therapeutic content and will wear a physiological monitoring device on their wrist (Empatica Embrace) which will monitor objective signals of physiological distress (e.g., skin conductance).

Eligibility Criteria:
Inclusion criteria:

* A recent suicide attempt or serious suicidal ideation (i.e., ideation with at least 70% intent or a suicide plan with access to lethal means),
* The ability to speak and write English fluently, access to an internet-capable smartphone (e.g., an iPhone or Android phone)
* Providing at least one collateral contact in cases where the investigators cannot reach the participant.

Exclusion criteria:

* The presence of any factor that impairs an individual's ability to comprehend and effectively participate in the study including:
* An inability to speak or write English fluently
* The presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, or acute intoxication.
* The presence of extremely agitated or violent behavior.
Dietary Antioxidants and Chronic Diseases-The Swedish National March Cohort

Dietary antioxidants might protect from the development of chronic diseases by reducing levels of oxidative stress. The investigators therefore investigated the effect of dietary Non Enzymatic Antioxidant Capacity, which measures interactions between antioxidants in the whole diet, on the risk of 1) myocardial infarction and 2) osteoarthritis.

Aim: Among an initial sample of 43,880 men and women who participated in the Swedish National March Cohort in 1997 the investigators aimed to investigate the effect of dietary Non Enzymatic Antioxidant Capacity (NEAC), assessed by a validated food frequency questionnaire at baseline, on the risk of 1) myocardial infarction and 2) osteoarthritis.

Identification of cases: Incident cases of myocardial infarction (ICD-10 code I21) and osteoarthritis (ICD-10 M15-19) were identified through exact linkages to the Swedish registries of population, migration, death, cancer, and inpatient care, using the national registration numbers as identifiers.

Main methods: The investigators fitted Cox proportional hazards regression models with age as underlying time scale to estimate hazard ratios (HR) with 95% confidence intervals (95% CI) for each outcome of interest at different levels of dietary NEAC. The investigators fitted multiple imputation models based on chained equations to address missingness of confounder variables.

Eligibility Criteria:
Exclusion Criteria Study 1:

* Incorrect national registration number
* Subjects who were \<18 years
* Emigration before beginning of follow-up
* Death before beginning of follow-up
* Cancer diagnosis
* Any cardiovascular disease
* Extreme energy intake

Exclusion Criteria Study 2:

* Incorrect national registration number
* Subjects who were \<40 years
* Emigration before beginning of follow-up
* Death before beginning of follow-up
* Osteoarthritis diagnosis
* Bone cancer- or metastases
* Joint injury or any arthropathy disease other than osteoarthritis
* Extreme energy intake
A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response

This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.

During a pre-study run-in phase patients with chronic hepatitis C genotype 2/3, who had started therapy with PEG-IFN alfa-2a plus ribavirin according to local standard of care and did not achieve a rapid viral response (RVR) (defined as Hepatitis C virus (HCV) RNA \<15 IU/mL at Week 4 of treatment measured with the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test) were eligible for the study and entered the screening phase between treatment Week 4 and 8 as soon as the result of the Week 4 HCV RNA test was available.

Eligible patients entered the study and continued with the dose regimens of PEG-IFN alfa-2a and ribavirin they were taking prior to enrolment into the trial up to Week 24 of treatment. Patients who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24, were randomized at treatment Week 24 to one of the two study groups. Upon randomization, participants either stopped treatment (equaling 24 weeks of treatment) or continued treatment for another 24 weeks (equaling 48 weeks of treatment). A treatment free follow-up period of 24 weeks (for participants in the 48-week treatment group) or 48 weeks (participants in the 24-week treatment group) completed the study.

Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* serological evidence of chronic hepatitis C (CHC);
* CHC genotype 2 or 3;
* receiving PEGASYS + Copegus according to local standard of care and no rapid viral response (RVR);
* compensated liver disease.

Exclusion Criteria:

* pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
* coinfection with hepatitis A or B, or human immunodeficiency virus (HIV);
* history or other evidence of decompensated liver disease.
Gastrointestinal Microcirculation During Cardiopulmonary Bypass

O2C is a diagnostic device for non-invasive determination of oxygen supply in microcirculation of blood perfused tissues. The optical sensor is easy to handle and guarantees reproducible examinations of local oxygen supply of tissues in clinics as well as in research. The examinations are without any strain for your patient.

Determines by use of a glass fibre probe:

Blood Flow in Microcirculation Capillary-Venous Oxygen Saturation Blood Filling of Microvessels Blood Flow Velocity This device makes it possible to supervise the local oxygen supply of organs and tissue.

With it is possible to measure locally the amount of oxygen which is transported into the region of interest and to diagnose local oxygen consumption of an organ. O2C's novelty is monitoring the energetic metabolism of cells by measuring the oxygen uptake with an optical sensor probe. Pathological O2-supply, which can lead to angiogenesis or cell-death and subsequently to organ failure, now can be detected in an early state by use of the new sensor system.

One of these new developed sensors are used to place in rectal position during extracorporeal circulation to determine the microcirculation.


Eligibility Criteria:
Inclusion Criteria:

* Patients on extracorporeal circulation

Exclusion Criteria:

* Haemorrhoidal lesions
Phase 1 Study of HRS-9231 Safety and Pharmacokinetics in Healthy Caucasians

This is a phase 1, randomized, double-blind, placebo-controlled study. The objective of this study is to evaluate the safety, tolerability, and PK profile of HRS-9231 injection following a single dose in healthy Caucasian participants.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Caucasian participants;
2. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
3. Male or female aged between 18 to 45 years of age (inclusive) at the date of signed consent form.
4. Women with body weight of ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass Index (BMI) between 18.0 and 32.0 kg/m2

Exclusion Criteria:

1. History or evidence of clinically significant disorders
2. Individuals with a history of drug allergies, specific allergies
3. Severe infections, injuries, or major surgeries as determined by the investigator within 3 months prior to dosing, or plan to do surgeries during the study.
4. Any other circumstances (e.g., not suitable for venous access) or laboratory
5. abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the Study or could preclude the evaluation of the participant's response.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia

The study will evaluate the effects of a nutrition supplement for pregnant women on birth weight and other outcomes. The hypothesis is pregnant women who consume a daily fortified food supplement will produce babies with a higher mean birth weight than those who do not.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* in first trimester of pregnancy
* plans to reside in the same village during the entire pregnancy

Exclusion Criteria:

* a minor
* not in first trimester of pregnancy
* plans to relocate during the pregnancy
Effects of an Urban-gardening Nutrition Intervention for Food Insecure College Students

The goal of this clinical trial is to learn if an urban gardening nutrition education program can have positive health effects on food insecure college students. The main question it aims to answer is to determine whether an 8-week urban-gardening nutrition intervention can improve fruit and vegetable intake, nutrition knowledge, Body Mass Index (BMI) and body fat percentage in college students with food insecurity.

Participants will:

Fill out a questionnaire regarding demographics, food insecurity, fruit and vegetable intake, nutrition knowledge, self-efficacy and health beliefs.

Allow researchers to measure height, weight and body fat percentage Participate in a 1-hour education cooking or gardening session once a week for 8 weeks Receive text message reminders for meeting dates


Eligibility Criteria:
Inclusion Criteria:

* Must be enrolled at FIU
* Age 18+ years old
* Literate in English
* Food insecure

Exclusion Criteria:

* Students who are student athletes
* Women who are pregnant or planning to become pregnant in the next 6 months
Psychotherapy for Depressed or Anxious Adolescents With Cancer

At present, there are no established treatments for depression or anxiety in adolescents with cancer, creating an important clinical and research gap. Fortunately, there is now substantial evidence documenting the efficacy of psychotherapy in the treatment of depressed and anxious adolescents in the general population.

Despite the high prevalence of depression and anxiety in cancer patients, little is known about the efficacy of psychotherapy in depressed and anxious adolescents with cancer.

Behavioral activation therapy (BAT) is a brief, manualized therapy that has shown efficacy in the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in several controlled trials patients, including adult cancer patients. The goal of this open label clinical trial is to obtain preliminary evidence of the efficacy of BAT(6 sessions) in a group of adolescent cancer patients with MDD, GAD or adjustment disorder with mood or anxiety features.

We will test the efficacy of BAT using the Multidimensional Anxiety Scale for Children at several time points of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* A primary psychiatric diagnosis of Major Depressive Disorder, Generalized Anxiety Disorder or Adjustment Disorder with Mood or Anxiety features as defined by DSM-IV.
* Cancer patients.
* Parent consent and child assent to participate for patients younger than 18. Patient consent for subjects 18-21.
* Diagnosis of cancer (stage 1-4), but healthy enough to complete study procedures.

Exclusion Criteria:

* Lifetime history of psychosis or bipolar disorder.
* Current suicide risk.
* History of substance abuse or dependence in the three months prior to the study.
* Patients who have ever failed BAT in the context of cancer.
* Receiving other concurrent therapy for same disorder and patients who are receiving effective medication for depression.
* Mental retardation.
* CNS tumors.
* Patients undergoing Stem Cell Transplantation.
Helicobacter Pylori Prevalence in Southern Region of Romania

Observational study, voluntary participation, 12 months, studying Helicobacter pylori prevalence.

Observational study, voluntary participation, 12 months, studying Helicobacter pylori prevalence.

The aim of the study is to evaluate the prevalence of H. pylori infection in several areas of the Southern Regions of Romania, considered as vulnerable pertaining to the access of health services.

Fecal Helicobacter pylori will be tested, together with antibiotic susceptibility.

Eligibility Criteria:
Inclusion Criteria:

* Adult voluntary participants to "Medical services caravan" project by Medcorp Association

Exclusion Criteria:

* Age \< 18 years old
* No informed consent
MINI-AMI: Minimizing Infarct Size With Impella 2.5 Following PCI for Acute Myocardial Infarction

A prospective, randomized, controlled multi-site feasibility trial to assess the potential role of the IMPELLA® 2.5 System in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI)

The primary objective of this study is to evaluate whether the adjunctive use of the IMPELLA® 2.5 System for 24 hours following primary PCI for STEMI has the potential to limit the infarction of at-risk myocardium compared to primary PCI with routine post-PCI care (standard of care). This study is a feasibility study. Therefore, the principal objective is to identify trends in cardiac magnetic resonance imaging (MRI)-based efficacy outcomes between the randomized treatment arms (Impella arm compared standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Signed Informed Consent
* Acute anterior STEMI with ≥2 mm of ST-segment elevation in 2 or more contiguous anterior leads or ≥ 4 mm in total in the anterior leads, OR, Large Inferior STEMI with ≥2 mm of ST-segment elevation in 2 or more inferior leads AND EITHER ≥1 mm ST-segment elevation in V1 OR ≥1 mm of ST-segment depression in ≥2 contiguous anterior leads (V1-V3)
* Primary PCI performed within 5 hours of the onset of symptoms
* Patient undergoing emergent primary PCI of one culprit lesion in one major native epicardial coronary vessel
* Successful revascularization of the culprit native coronary artery with TIMI Flow Grade of 3 at the end of PCI

Exclusion Criteria:

* Cardiac arrest requiring CPR within 24 hours prior to enrollment
* Current cardiogenic shock
* Left Bundle Branch Block (new or old)
* Atrial fibrillation
* Known history of prior MI
* Prior coronary artery bypass graft surgery
* Known mural thrombus in the left ventricle or contraindication to left ventriculography
* Presence of a mechanical aortic valve
* Documented presence of moderate to severe aortic stenosis or moderate to severe aortic insufficiency.
* Known history of severe kidney dysfunction.
* Known contraindication to MRI (implanted metallic or magnetically activated device; claustrophobia, inability to hold breath for 15 seconds).
* History of recent (within 1 month) stroke or TIA
* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
* Administration of fibrinolytic therapy within 24 hours
* Known hypersensitivity or contraindication to any of the following: Heparin, pork or pork products; Aspirin, All of the following: Clopidogrel, Ticlopidine, Prasugrel
* Contrast media Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device.
* Severe peripheral arterial obstructive disease that would preclude the IMPELLA® System placement
* Requirement to treat two or more culprit vessels during primary PCI, or plan for staged coronary revascularization (PCI or CABG) within the next 30 days.
* Inability to place Impella within 6 hours of the onset of symptoms, should patient be randomized to this arm.
Antibiotyping and Prevalence of Virulent Genotypes Among Helicobacter Pylori and Their Impact on Response to Therapy

* Detection of primary antimicrobial susceptibility and resistance of Helicobacter Pylori infection.
* Detection of resistance and virulence genes of Helicobacter Pylori infection.
* Assessment of H pylori carcinogenicity gene.
* Evaluation of outcome and efficacy of antibiotics regimen will be used in our research.
* Evaluation of effect of other factors as diet (fatty and spicy meal), drugs as NSAIDs use, antibiotics for any cause on response of H pylori to antibiotics regimen.

Helicobacter pylori (H. pylori) infection is one of the most common infections in humans, affecting more than half of the world population. New infections are thought to occur as a consequence of direct human-to-human transmission or environmental contamination.

The prevalence of the infection varies widely in rural developing areas (more than 80%) compared to urban developed ones (less than 40%), as a consequence of different socioeconomic and hygienic conditions .

The vertical mode is infection spread from ascendant to descendent within the same family, while horizontal transmission involves contact with individuals outside the family or environmental contamination.

Most individuals are infected by Helicobacter pylori during early childhood; in developing countries. Successful eradication is important to prevent the development of antibiotic resistance, as well as to reduce the number of treatments and procedures. Thus, national/ regional antibiotic resistance data could be used to guide treatment regimens for H pylori infection .

Several clinical factors associated with increased rates of antibiotic resistant H. pylori, including history of previous antibiotic exposure, increasing age, female gender, ethnicity/race, extent of alcohol use, and non-ulcer dyspepsia .

The primary antibiotic resistance of H. pylori is increasing worldwide. The overall resistance rate was found to be 4.55% for amoxicillin; 27.22% for clarithromycin; 39.66% for metronidazole; and 22.48% for levofloxacin.

Therefore, drug susceptibility result of these antibiotics is necessary to select the appropriate drug for the successful eradication of the infection.

Helicobacter pylori exhibit specific geographic distributions that are related to clinical outcomes. Despite the high infection rate of H. pylori throughout the world, the genetic epidemiology surveillance of H. pylori still needs to be improved.

Eligibility Criteria:
Inclusion Criteria:

- Any patient is above 18 years old with symptomatic H pylori infection patients diagnosed by positive H pylori Ag in stool (naïve treatment).

Exclusion Criteria:

* Patients who aren't eligible to endoscopy.
* Patients are under 18 years old
* Patient's refusal
* history of antibiotics or proton pump inhibitor use during last month.
Busulfan Sample Collection Study

Busulfan (Busulfex®) is an alkylating drug used as a conditioning regimen prior to allogeneic hematopoietic stem cell transplantation. Busulfan has wide inter- and intra-patient pharmacokinetic variability resulting in variable exposure leading to increased risk of toxicities or sub-optimal treatment outcomes. Therapeutic drug monitoring of busulfan using patient plasma samples would benefit clinicians by providing the ability to personalize the dose to achieve a target busulfan exposure.

This protocol is sponsored by Saladax Biomedical, Inc (SBI). The protocol involves the use of sodium heparin plasma sample collected from human subjects receiving intravenous busulfan treatment for the use in the development of a diagnostic test for this drug. A subset of 10 enrolled subject samples will be tested on site using an automated immunoassay MyCareTM Oncology Busulfan Assay Kit manufactured by SBI.

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric and adult female or male subjects;
2. Current treatment with intravenous busulfan with documentation of diagnosed malignant hematologic or non-malignant disease condition requiring treatment;
3. Adult participants must be capable of understanding and providing written informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any screening or study-specific procedures. Participants less than 18 years old must provide written assent with appropriate consent provided by legal guardian, who must be capable of understanding and providing informed consent, per Institutional Review Board (IRB) procedures, prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria:

1. Unwilling or unable to follow protocol requirements or to give written informed consent;
2. Patients receiving oral busulfan (e.g., Myleran®) treatment.