cyrilzakka/clinical-trials huggingface dataset:
Adult Study Oxytocin - fMRI

In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia.

Aim 1: To examine the effects of exogenous oxytocin on patterns of neural activation as measured by fMRI during a well-characterized affect-labeling task in patients with recent-onset schizophrenia and healthy comparison subjects.

Hypothesis A: Patients will exhibit amygdalar hyperactivity and PNS hypo-activity when passively viewing faces, which will be normalized by administration of oxytocin.

Hypothesis B: Patients will exhibit hypo-activity of the vPFC when affectively labeling faces and this hypo-activity will be normalized by oxytocin administration.


Eligibility Criteria:
Inclusion Criteria for Patients:

* Male
* SCID-IV confirmed diagnosis of schizophrenia or schizoaffective disorder
* Clinically stable
* No changes to medications for the past week

Inclusion Criteria for Healthy Controls:

* Male
* SCID-IV confirmed no diagnosis of a current Axis I disorder within the last year

Exclusion Criteria for Patients and Healthy Controls:

* Meeting criteria for current substance abuse or dependence or illicit drug use within the last month (nicotine use is acceptable) as determined by a Urine Toxicology Drug Screening
* Any illness that affects the nasal passages and impairs the delivery of a nasal spray
* Presence of any neurological or significant medical disorder, including medical illnesses that could interfere with physiological recording such as cardiac arrhythmias
* A pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos
* Pregnancy
* Claustrophpbia
* Hearing difficulties
* A history of seizures
* Failure to receive a passing score on the reading test

Additional Exclusion Criteria for Patients and Healthy Controls:

* Taking any psychotropic medication or any medication that affects the autonomic or cardiovascular systems.
* Schizophrenia or other psychotic disorder in a first degree relative
* Failure to receive a passing score on the MOCA
A Randomised Trial of Artekin and Artesunate & Amodiaquine for Uncomplicated Malaria in Timika, Papua, Indonesia.

The primary aim of the comparative trial is to assess the relative safety and efficacy of two artemisinin containing regimens: amodiaquine plus artesunate (AAQ) and artekin both administered once daily for 3 days.

With the emergence of species of multi drug resistant P.falciparum across the archipelago the Indonesian Centre for Disease Control (CDC) now recommends amodiaquine plus artesunate in areas of high chloroquine and sulfadoxine-pyrimethamine resistant strains of P. falciparum. High levels of chloroquine resistance to P.vivax has also emerged in the eastern provinces.

This trial sets out to assess the efficacy of artekin and amodiaquine plus artesunate and artekin against both P.falciparum and P. vivax.

and their safety profiles.

Patients who present to an established rural outpatient clinic in Timika, Papua with symptoms of acute, uncomplicated infection with P. falciparum, P.vivax or both species, will after laboratory confirmation of the diagnosis and having given informed consent to participate in the trial, be enrolled in the study. Patients will be treated as out-patients and then seen daily for the first week until aparasitaemic and thereafter at weekly visits to the clinic.

The data used from this trial will be used to make a public health decision to determine a suitable alternative first line antimalarial in the Timika region. In order to ensure that the data gathered will be relevant to the clinical setting in which the drugs will be used, drug administration of medication will be deliberately designed to mimic conditions that will be experienced with widespread deployment (eg once daily supervision).

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients at least one 1year of age and weighing more than 5kg.
* Microscopic confirmation of P. falciparum and /or P.vivax infection (any parasitaemia).
* Fever (axillary temperature \>37.5oC) or history of fever in the last 48 hours.
* Able to participate in the trial and comply with the clinical trial protocol
* Written informed consent to participate in trial; verbal consent in presence of literate witness is required for illiterate patients, and written consent from parents/guardian for children below age of consent

Exclusion Criteria:

* Pregnancy or lactation
* Inability to tolerate oral treatment
* Signs/symptoms indicative of severe/complicated malaria or warning signs requiring parenteral treatment
* Known hypersensitivity or allergy to artemisinin derivatives
* Serious underlying disease (cardiac, renal or hepatic)
* Parasitaemia \>4%
Post-Approval Study of the Guidant Carotid Stent Systems and Embolic Protection Systems: CAPTURE

This purpose of this study is to collect data on the FDA-approved ACCULINK(TM) Carotid Stent System and FDA 510(k)-cleared ACCUNET(TM) Embolic Protection System for the treatment of patients with atherosclerotic disease, when used by physicians under commercial use conditions.

CAPTURE is a post-approval study to collect information on the safety and effectiveness of the ACCULINK and ACCUNET since the approval/clearance of these devices by the FDA. The ACCULINK stent is an elastic-like metal tube that is used to hold open a narrow part of a blood vessel. The ACCUNET is a wire mesh basket that is placed in the vessel to catch material (blood clots, fatty material) that could break off from the narrowed area of the blood vessel and block blood flow downstream during the stent procedure.

Another goal of the CAPTURE study is to confirm that the ACCULINK and ACCUNET can be used safely by physicians with varying levels of experience in stenting procedures.

The basis for FDA's approval/clearance of the ACCULINK and ACCUNET was the ARCHeR trials (ACCULINK/ACCUNET for Revascularization of Carotids in High-Risk Patients). The ARCHeR trials were conducted to collect data on the safety and effectiveness of the ACCULINK and ACCUNET when used in the treatment of carotid artery disease in patients at high risk for surgical treatment (carotid endarterectomy) because of medical or surgical comorbidities. The ARCHeR trials showed that the ACCULINK, used with or without the ACCUNET, is a safe and effective treatment option based on the rate of death, stroke, and myocardial infarction at 30 days, and stroke at one year.

Eligibility Criteria:
Inclusion Criteria:

* Patient's physician used an ACCULINK and/or ACCUNET
The Effect of Telephone and Video Counseling on Weight Loss and Quality of Life

Individuals with obesity are at higher risk for severe disease, hospitalizations, and death from the SARS-CoV-2 virus. Social distancing guidelines intended to prevent viral spread during the COVID-19 pandemic resulted in major changes to daily routines . Several studies have demonstrated that individuals with overweight/obesity reported worsening mental health, poor eating habits , less physical activity (PA) since the onset of the COVID-19 pandemic. Because of these pandemic rules, the use of phone/video consultancy applications and online classes for body weight control and diet monitoring is increasing. Therefore, in this study it is aimed to determine the effect of diet counseling via phone or video on weight loss and to compare it with the traditional follow-up method in the COVID-19 pandemic.

The use of phone/video consultancy applications for body weight control and diet monitoring is increasing. One of the main reasons for this situation is that individuals care more about the social distance rule as a result of the increase in health concerns after the COVID-19 (SARS-CoV-2) pandemic. In addition, due to the uncertainty of how long the pandemic will last, many people are adapting to online applications and programs quicly. However, it's unclear which method of phone/video-based diet counseling is more successful or preferable to traditional diet follow-up. Based on the above-mentioned information; in this study, it is aimed to determine the effect of diet counseling via phone or video on weight loss and to compare it with the traditional follow-up method in the COVID-19 pandemic.

Individuals who meet the research criteria will randomize according to their file numbers (with the ramdomizer program) and divide into 3 groups: telephone counseling (15), video counseling (15) and traditional follow-up group (Figure 1.). Food consumption records, anthropometric measurements and quality of life scale scores of all individuals will record at the beginning and end of the study (Figure 2.). In order to prevent interaction between individuals, all diet programs will prepare at different times and individually.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 20-65
* Being obese (BMI≥30 kg/m2)
* Having a smartphone with internet access and being competent to use it
* Volunteering to participate in research

Exclusion Criteria:

* Being pregnant/lactating
* Having a hearing problem
* Being on a followed diet program
The Microbiology of Pleural Infection

Pleural Infection (PI) is a common, severe and complicated disease with considerable morbidity and mortality. (1,2) The knowledge of pleural infection microbiology remains incomplete. Sequencing of the bacterial 16S rRNA gene is a reliable methodology to discover the total microbiome of complex samples.

The investigators designed a translational metagenomics study to study the bacteriology of pleural infection. The investigators will use pleural fluid specimens from a) the "Prospective validation of the RAPID clinical risk prediction score in adult patients with pleural infection: the PILOT study" (3) clinical trial and b) non-pleural infection patients. The pleural fluid specimens will be subjected to 16S rRNA next generation sequencing.

Pleural Infection (PI) is a common, severe and complicated disease with considerable morbidity and mortality1,2. Patients develop pleural effusions of frankly infected fluid. The understanding of pleural infection microbiome could improve patient clinical management, however the knowledge remains incomplete. Sequencing of the bacterial 16S rRNA gene is a reliable methodology to discovery the total microbiome of complex samples.

The investigators designed a translational study to study the bacteriology of pleural infection. Pleural fluid specimens from a) the "Prospective validation of the RAPID clinical risk prediction score in adult patients with pleural infection: the PILOT study" (3) clinical trial and b) non-pleural infection patients will be subjected to bacterial DNA extraction followed by 16S rRNA next generation sequencing. Moreover, the investigators will study the association between bacterial patterns and important clinical outcomes including survival, duration of hospitalisation and need for surgery.

Eligibility Criteria:
The pleural fluid specimens were collected for the "Prospective validation of the RAPID clinical risk prediction score in adult patients with pleural infection: the PILOT study". PMID: 32675200 DOI: 10.1183/13993003.00130-2020. The investigators analysed the samples retrospectively.

Inclusion Criteria:

* As per protocol of the "Prospective validation of the RAPID clinical risk prediction score in adult patients with pleural infection: the PILOT study". PMID: 32675200 DOI: 10.1183/13993003.00130-2020

Exclusion Criteria:

* As per protocol of the "Prospective validation of the RAPID clinical risk prediction score in adult patients with pleural infection: the PILOT study". PMID: 32675200 DOI: 10.1183/13993003.00130-2020
A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia

The goal of this \[clinical trial\] is to \[evaluate the safety and efficacy of olanzapine-samidorphan tablets\] in \[adults with schizophrenia\]. The main question\[s\] it aims to answer are:

* \[question 1\] Olanzapine-samidorphan significantly mitigate weight gain better than olanzapine.
* \[question 2\] Olanzapine- samidorphan and olanzapine have similar antipsychotic efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Subject is age 18 to 55 years, inclusive.
* Subject has a BMI of 18.0 to 30.0 kg/m2, inclusive.
* Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia.
* PANSS total score ≥ 70.

Exclusion Criteria:

* Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder, or any other psychiatric condition that could interfere with participation in the study.
* Subject poses a current suicide risk in the opinion of the investigator.
* Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder.
* Subject has a history of diabetes.
* Subject has used olanzapine, clozapine, chlorpromazine, or thioridazine at any time during the 6 months prior to screening or long-acting injectable antipsychotic medication in the last 6 months.
* Subject has taken opioid agonists within the 14 days prior to screening and/or anticipates a need to take opioid medication during the study period, or has taken opioid antagonists within 60 days prior to screening.
* Subject is taking any weight loss agents or hypoglycemic agents at screening.
* Subject has had a surgical procedure for weight loss or is planning to have liposuction during the study.
* Subject has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of efficacy.
Early Oral Nutrition in Mild Acute Pediatric Pancreatitis

This is a prospective trial for children with the diagnosis of mild acute pancreatitis admitted to the hospital for continued management. Patients will be enrolled in the study within 24 hours of admission/diagnosis and will be allowed an oral diet once enrolled. Demographic, laboratory and imaging data done as standard of care will be collected and additional blood work will be sent as part of the study. Patients will be followed prospectively with regards to tolerance to oral nutrition, pain, length of stay and complications. The hypothesis is that patients that are able to tolerate early oral nutrition will have shorter length of stays and will be similar in terms of pain score ratings, readmission rates, complications and the need for invasive supplemental nutrition. Also patients that are able to tolerate early oral nutrition will have less significant elevation of biochemical markers of pancreatitis severity when compared to patients that do not tolerate early oral nutrition and historical controls.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute pancreatitis
* Enroll within 24 hours of diagnosis
* At least 50% of baseline diet must be taken orally

Exclusion Criteria:

* Evidence of severe pancreatitis
* Diagnosis of chronic pancreatitis
* Patients unable to communicate pain or a desire to eat/drink
Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects

This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.

PregSense™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate, maternal hear rate and uterine contractions. This study will be performed to collect and digitally record data from PregSense™ and the standard of care (CTG) in order to provide evidence of safety and agreement between PregSense™ and the gold standard NST device.

Eligibility Criteria:
Inclusion Criteria:

* Female age between 18-50
* Gestational age \> 32 + 0 weeks
* Singleton gestation
* Ability to understand and sign informed consent

Exclusion Criteria:

* BMI (Body Mass Index) ≥ 45 and ≤15 prior pregnancy
* Multiple gestation
* Uncontrolled Hypertension
* Fetal Anomaly
* Subjects with skin problems in the abdominal area (such as flesh wounds, cuts in the skin, skin rashes, etc.)
* Subjects with implanted electronic devices (pacemaker, defibrillator, etc.)
* Subjects who, in the judgement of the investigator, are likely to be non-compliant or uncooperative during the study
Nursing Intervention in Supporting Family Caregivers of Patients Undergoing Stem Cell Transplant

This randomized clinical trial studies nursing intervention in supporting family caregivers (FCs) of patients undergoing stem cell transplant. A nursing intervention may help prepare FCs support the recovery of the patients

PRIMARY OBJECTIVES:

I. Test the effects of an advanced practice nursing (APN) intervention for family caregivers (FCs) of hematopoietic cell transplant (HCT) patients in the experimental group on FC quality of life, psychological distress, caregiver burden, caregiver skills preparedness as compared to FCs in the control group.

II. Describe self-care behaviors for FCs of HCT patients and compare them between the experimental and control groups.

III. Describe resource use by FCs comparing the experimental and control groups.

IV. Identify subgroups of FCs who benefit most from the family caregiver intervention (FCI) in relation to sociodemographic characteristics, caregiver health status, and patient characteristics.

SECONDARY OBJECTIVES:

I. Describe family caregivers' satisfaction with the FCI.

OUTLINE: FCs are randomized to 1 of 2 groups.

GROUP I: FCs receive 4 sessions of an APN FCI beginning during the admission for transplant and continuing for up to 100 days after transplant.

GROUP II: FCs receive standard supportive care.

After completion of study, FCs are followed up at 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* The primary family caregiver as identified by a hematologic cancer patient who is scheduled for a single allogeneic bone marrow or stem cell transplant; the definition of a family caregiver for the purposes of this proposal refers to either a family member or friend that is identified by the patient as being the primary caregiver
* Living within a 50 mile radius of City of Hope

Exclusion Criteria:

* Caregivers who are unable to read English or Spanish consent forms
* Caregivers who live more than 50 miles from City of Hope
Food Preference Following Bariatric Surgery

Roux-en-Y gastric bypass (RYGB) decreases appetite, caloric intake, glycemia, and body weight, all of which are maintained long term.It is controversial whether, after RYGB, patients choose to eat less high fat and sugary foods in favor of lower energy dense alternatives. Therefore the proposition to use direct measures in humans after RYGB to test the hypothesis that the selection and intake of foods varying in fat content and glycemic index, as well as the pattern of ingestion within and across meals, changes in a manner that leads to beneficial outcomes on body weight.

Roux-en-Y gastric bypass (RYGB) decreases appetite, caloric intake, glycemia, and body weight, all of which are maintained long term.It is controversial whether, after RYGB, patients choose to eat less high fat and sugary foods in favor of lower energy dense alternatives. If true, this could conceivably contribute to improved glycemia and body weight. Disparities among studies on food selection and intake are likely due to the almost complete reliance on self-reported food intake which is vulnerable to inaccuracy.This controversy can best be resolved by complementing existing findings with direct measures of target behaviour in humans. Therefore the proposition to use direct measures in humans after RYGB to test the hypothesis that the selection and intake of foods varying in fat content and glycemic index, as well as the pattern of ingestion within and across meals, changes in a manner that leads to beneficial outcomes on body weight.

Eligibility Criteria:
Inclusion Criteria:

1. Surgical and non-surgical groups:

   A) Bariatric surgery B) Controls with no history of bariatric surgery
2. Independently mobile
3. Capacity to consent to participate
4. \>18 years of age

Exclusion Criteria:

1. Pre-operatively: significant dysphagia, gastric outlet obstruction or anything that prevents subjects from eating a meal.
2. Post-operatively: significant and persistent surgical complications or anything that prevents subjects from eating a meal.
3. Systemic or gastrointestinal condition which may affect food intake or preference, including:

   i) pregnancy or ii) breast feeding.
4. Active and significant psychiatric illness including substance misuse
5. Significant cognitive or communication issues
6. Medications with documented effect on food intake or food preference
7. History of significant food allergy and certain dietary restrictions
8. History of liver disease or pancreatitis
9. History of bradyarrythmia or congestive cardiac failure group)
10. Use of medications with potential serious interactions with Octreotide
AF at Home: A Virtual Education Program for Patients With Atrial Fibrillation (AF)

The goal of this study is to determine the effectiveness of a direct-to-patient virtual education program ("AF at Home") for adults with atrial fibrillation (AF). The main questions this study aims to answer are:

1. Will participants in the educational program have improvement in quality of life, self-monitoring, and self-management strategies after program completion?
2. Will patient level quality of AF care improve for participants in the educational program?

Participants will be asked to:

* Participate in six hours of virtual education sessions over three weeks via Zoom.
* Complete online questionnaires before the program starts and after its completion.


Eligibility Criteria:
Inclusion Criteria:

* Patient with diagnosis of non-valvular or valvular atrial fibrillation
* Age \>/= 18

Exclusion Criteria:

* Unable to provide informed consent
* Incarcerated patient
Management of Highly Active Anti-retroviral Therapy-related Hyperlipidemia Among HIV-infected Patients in Taiwan

1. Written informed consent must be obtained before any study specific procedures are undertaken.
2. The process of the experiment (brief describe) The patients must come back for follow during 4 to 12 weeks after starting the new therapy. The investigators will follow the patients' lipid profile and any side effects and stop the observation till 36 months after starting the new therapy. The serum level of HIV-VL, CD4, GOT, GPT, triglyceride, cholesterol, HDL-cholesterol, and LDL-cholesterol will be checked every 3 months. The patients' chart and all data will be delinked to protect the patients' right and privacy.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected patients who receive HAART therapy but have metabolic side effects.
* Age over 20 years old

Exclusion Criteria:

* Abnormal liver function: GOT or GPT 5 times over normal upper limit