cyrilzakka/clinical-trials huggingface dataset:
HIV Risk Reduction and Drug Abuse Treatment in Iran

A randomized, double blind clinical trial comparing buprenorphine and naltrexone maintenance treatment when combined with drug abuse and HIV risk reduction counseling (DC-HIV) for heroin and opium addicts in Iran.

This randomized double blind clinical trial compares the efficacy of buprenorphine maintenance treatment (BMT) and naltrexone maintenance treatment (NMT) for recently detoxified opioid dependent patients (N=130; 65 heroin dependent, 65 opium dependent-Specific Aim 1). Manual-guided, HIV risk reduction and drug counseling (DC-HIV) is provided to all patients as the platform psychotherapy. Maintenance treatment is provided for 12 weeks to all patients; patients may also continue to receive maintenance treatment for an additional 12 weeks following the initial treatment period. Primary outcome measures, assessed by twice weekly urine toxicology testing and self-report during the first 12 weeks and monthly during the 12-week extension, include resumption of heroin use, 1 and 3 weeks continuous relapse and reductions in HIV risk behaviors. The project will also evaluate the characteristics of treatment-seeking opioid addicts in Iran (including specific risk behaviors and patterns of HIV risk behaviors; prevalence of psychiatric and other medical comorbidity; and patterns of social, family, vocational, and criminal activity and service needs-Specific Aim 2). This data will be used to revise the DC-HIV manual to address the specific circumstances and risk behaviors of opioid addicts in Iran and to provide data regarding any differential response of opium compared to heroin addicts to BMT or NMT. Finally, the project will also provide clinical training for health professionals and training and mentoring in drug abuse treatment and HIV prevention research to clinical researchers who will continue development, implementation, evaluation and dissemination of HIV prevention and drug abuse treatment approaches in Iran after the project ends (Specific Aim 3). The Institute for Cognitive Science Studies will collaboratively fund the project and lead subsequent dissemination and drug abuse and HIV risk reduction efforts in Iran.

Eligibility Criteria:
Inclusion Criteria:

* Opioid Dependence

Exclusion Criteria:

* Dependence on alcohol, benzodiazepines or sedatives
* Suicide or homicide risk
* Psychotic disorder or major depression
* Inability to read or understand the protocol or assessment questions
* Life-threatening or unstable medical problems
* Greater than 3 times normal liver enzymes (AST, GGT)
CD34+Selection for Partially Matched Family or Matched Unrelated Adult Donor Transplant

CD34+ stem cell selection in children, adolescents and young adults receiving partially matched family donor or matched unrelated adult donor allogeneic bone marrow or peripheral blood stem cell transplant will be safe and well tolerated and be associated with a low incidence of serious (Grade III/IV) acute and chronic graft versus host disease (GVHD).

The selection of CD34+ cells is associated with the simultaneous depletion of T cells that are responsible for severe acute and chronic graft versus host disease (GVHD). Successful engraftment is reported in adult patients with malignant and non-malignant disease who received CD34+ selected stem cells from HLA-matched or mismatched mobilized peripheral blood (PBSC) or bone marrow.

Study Design:

Selected patients defined in the eligibility criteria will enrolled on this study. Patients will receive one of either full intensity or reduced intensity regimen based on the patient's disease status, organ function and performance and determined by the PI and will have peripheral blood undergo CD34 selection.

Eligibility Criteria:
Inclusion Criteria:

* Adequate renal function defined as:Serum creatinine \<1.5 x normal, or Creatinine clearance or radioisotope GFR \>60 ml/min/m2 or an equivalent GFR as determined by the institutional normal range.
* Adequate liver function defined as:Total bilirubin \<1.5 x normal, or SGOT (AST) or SGPT (ALT) \<3.0 x normal
* Adequate cardiac function defined as:Shortening fraction \>27% by echocardiogram, or Ejection fraction of \>47% by radionucleotide angiogram or echocardiogram.
* Adequate pulmonary function defined as:Uncorrected DLCO \>50% by pulmonary function test. For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \>94% on room air.

Eligibility for Reduced Intensity Regimen:

* Adequate renal function defined as:Serum creatinine 2.0 x normal, or creatinine clearance or radioisotope GFR \> 40 ml/min/m2 or an equivalent GFR as determined by the institutional normal range.
* Adequate liver function defined as:Total bilirubin \< 2.5 x normal; or SGOT (AST) or SGPT (ALT) \< 5.0 x normal.
* Adequate cardiac function defined as:Shortening fraction of \>25% by echocardiogram, or Ejection fraction of \>40% by radionuclide angiogram or echocardiogram.
* Adequate pulmonary function defined as:DLCO \>35% by pulmonary function test. For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \>94% in room air.

Exclusion Criteria:

* Pregnancy/Breast Feeding: Females who are pregnant or breast-feeding are not eligible.
* Infection: Patients with documented uncontrolled infection at the time of study entry are not eligible.
Feasibility of Implementing Acupuncture Into Federally Qualified Health Center Among Breast Cancer Survivors

The purpose of this study is to test the feasibility of implementing acupuncture intervention in federally qualified health centers oncology clinics for breast cancer survivors.

This study has the following specific aims:

Aim 1: Test the feasibility and acceptability of implementing a 5-week acupuncture intervention within federally qualified health center oncology clinic to manage multiple symptoms (pain, hot flashes, fatigue, sleep disturbance, depression, anxiety) among breast cancer survivors receiving endocrine therapy.

Aim 2: Use a mixed methods approach to identify barriers and facilitators associated with implementing acupuncture in federally qualified health center oncology clinic.

Eligibility Criteria:
Inclusion Criteria:

* women with histologically confirmed stage 0, I, II, or III breast cancer
* \> 18 years of old
* who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) in the past 1 month and currently taking endocrine therapy
* are able to read and speak English
* with self-reported pain, fatigue, sleep disturbance, depression, hot flashes and/or anxiety in the last month and their average severity rating ≥ 3 (0-10 numeric rating scale) for at least 3 of the 6 symptoms, and experience at least 2 physical symptoms (pain, fatigue, sleep disturbance).

Exclusion Criteria:

* Metastatic breast cancer (stage IV)
* have a bleeding disorder (e.g. hemophilia, Von Willebrand's disease, thrombocytopenia)
* failure to comply with weekly visits to the acupuncture clinic during the interventional phase of the study
* Psychiatric or medical disorders which would affect study assessments, such as, dementia, Alzheimer's disease, a history of any neurological condition, traumatic brain injury, stroke, and the use of psychotropic medication
* Breastfeeding, pregnant or are planning get pregnant during the study period
NGLY1 Deficiency: A Prospective Natural History Study

NGLY1 deficiency is a rare genetic disorder that is characterized by: global developmental delay and/or intellectual disability, hypo- or alacrima, transient elevation of transaminases, and a hyperkinetic movement disorder. Significant phenotypic variability has been observed in the small number of affected individuals described in the medical literature.

The purpose of this study is to describe the natural history of NGLY1 deficiency in a prospective, detailed, and highly uniform manner. Study participants will be closely monitored over the course of five years in order to:

* understand the clinical spectrum and progression of NGLY1 deficiency using standardized clinical and neurodevelopmental assessments
* identify clinical and biomarker endpoints for use in therapeutic trials, and
* identify genotype-phenotype correlations

Close clinical follow-up will allow for generation of a rich dataset and detailed understanding of the natural history of NGLY1 deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Parent(s)/legal representative and/or participant must be willing and able to give informed consent/assent for participation in the study
* Males or females of any age
* Suspected or confirmed diagnosis of NGLY1 deficiency with genetic variants in both NGLY1 alleles and consistent clinical characteristics
* Participant and caregiver must be willing to provide clinical data, participate in standardized assessments, and provide biological samples (if living in the United States)
* Willingness to travel to Palo Alto, CA is favored, but not required

Exclusion Criteria:

* The presence of a second, confirmed disorder, genetic or otherwise, affecting neurodevelopment or with other overlapping symptoms of NGLY1 deficiency
Nasopharynx Microbiota Component and in Vitro Cytokines Production in Coronavirus Disease (COVID-19)

The investigators will study nasopharunx microbiota composition, RNA sequences and in vitro cytokines production by peripheral blood cells of COVID-19 patients (both mild-moderate and severe cases) (comparing with convalescent patients and healthy controls).

The investigators will compare study parameters (basal) between mild-moderate and severe COVID-19 patients and with other study groups (i.e. convalescent and healthy controls). Nasopharunx microbiota dysbiosis, in vitro cytokines production profile, and peripheral blood flocytometric results of the four study groups will be compared.

In vitro cytokines production will be studied and compared in Nill (No antigens) and Mitojen (Cocktail of antigens) pre-prepared test tubes.

Eligibility Criteria:
Inclusion Criteria:

* Ability to give a written consent

Exclusion Criteria:

* In ability to give a written consent
* Using of medications that affect the results of study parameters
* Presence of malignancy or tuberculosis
The Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

To investigate the pharmacokinetic Drug-drug interaction

The purpose of this study is to investigate the pharmacokinetic Drug-Drug(telmisartan, amlodipine and/ or rosuvastatin) interaction and safety in healthy male volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteers aged 19 to 50
2. Participant who has a body weight that is \>=55kg(male) and body mass index (BMI) level that is 18\~30
3. Provision of signed written informed consent

Exclusion Criteria:

1. History of clinically significant disease
2. History of clinically significant hypersensitivity or hypersensitivity reactions to drugs and other medications (aspirin, antibiotics, etc.), including components such as Telmisartan, Rosuvastatin and Amlodipine
3. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
4. Administration of other investigational products within 2 months prior to the first dosing.
5. Administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study)
6. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to the reasons including laboratory test results, ECGs, or vital signs.
Evaluation of the Safety and Outcomes of Outpatient Management With Mild to Moderate COVID-19 Pneumonia

The purpose of this study is to evaluate the strategy of investigators for outpatients SARS-CoV-2 moderate pneumonia management in terms of efficacy and patient safety. The investigators ultimate goal is to validate first wave management strategy in order to support the investigators future approach in the event of a second wave, and spare the hospital resources by safely keeping at home as many patients as possible.

The investigators focused on participants consulting in the emergency department at the HUG who remained in an outpatient setting, with pneumonia and moderate illness, defined by individuals who have evidence of lower respiratory disease by clinical assessment or imaging and a saturation of oxygen (SaO2) \>93% on room air and no other hospitalization criteria (CURB 65 score below 2points).

For patients' follow-up, the investigators have created an aftercare ambulatory unit, open 5/7 days. The investigators were able to conduct 64 consultations between April 2 and May 5, 2020. Every participant had suspected or confirmed SARS-CoV-2 pulmonary tract infection.

The follow-up data was entered into DPI (patient's medical record at HUG) on a specific consultation form. Patients followed in the investigators consultation were contacted between 30 and 60 days after diagnosis by the Covicare team. The Covicare team is call-center composed of medical students and primary care physicians who remotely followed patients with COVID-19 by calling them by phone or telemedicine every day or every other day depending on patients' needs and health status. The investigators will export data from RedCap concerning post-hospitalization, satisfaction survey on our care and oral consent for use of data (ARGOS study CCER number 2020-01273).

Eligibility Criteria:
Inclusion Criteria:

* All persons with suspected or confirmed SARS-CoV-2 pneumonia who consulted in the emergency department of the HUG without criteria for hospitalization4 (Pneumonia with CURB-65 \>= 2 or new O2 dependency or increased O2 requirements or sustained respiratory rate≥20 min or decompensated comorbidity or major alteration of the general state) and who have been scheduled for outpatient follow-up in HUG.

Exclusion Criteria:

* Patients with hospitalization criteria
* Refusal to consent documentation found in the computerized patient record or oral refusal consent during follow up call.
Reduced ER-QOL in Families After Congenital Cataract Surgery

Children after congenital cataract surgery experience a lower quality of life and reduced functional vision. Their families have also been seriously affected. Investigators should pay more attention to them, and measures should be administered to families.


Eligibility Criteria:
Inclusion Criteria:

* visually not significant cataract, and ophthalmic surgery (incisional or laser) within one month

Exclusion Criteria:

* parents who were inability to communicate were also excluded
Toward Gender Aware VA Healthcare: Development and Evaluation of an Intervention

The purpose of this study was to develop and evaluate an educational program intended to raise staff awareness about women veterans and their health care needs and preferences.

OBJECTIVES:

The primary objective of this project was to develop and evaluate a computerized program that would enhance Veterans Health Administration (VHA) employees� awareness of women veterans and their health-care needs. The program was designed to challenge negative stereotypes about female patients (gender-role ideology), increase empathy toward female patients� needs (gender sensitivity), and enhance knowledge regarding women veterans and aspects of their VHA care (knowledge).

DESIGN/METHODS:

Phases I involved generating content for the computerized interactive program. Phase II involved creating the 30-minute program. The Phase III evaluation of the program involved a two-group pretest�posttest�follow-up equivalent control group design at two facilities with a third facility comparison group. At the first two facilities, employees who provide either direct or ancillary care to patients were randomly assigned to either the treatment or the control group. Participants in the treatment group completed the program entitled Caring for Women Veterans. Participants in the control group and those at the third site completed a 30-minute program entitled Managing Stress. The data from the third site were included to test for infusion of the treatment effect within same-site groups. Gender awareness was evaluated at three time points using the Gender Awareness Inventory-VA (GAI-VA). Participants completed the GAI-VA several weeks prior to completing the computerized program (Time 1, n =339), immediately after completing the program (Time 2, n = 249), and approximately one month after the program (Time 3, n = 167). Participants also completed a qualitative evaluation of the program at Time 2.

STATUS:

Complete.

Eligibility Criteria:
Inclusion Criteria:

Participants must be VHA employees who have direct or indirect contact with patients.

Exclusion Criteria:

Employees who have no contact with patients.
Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction.

This study will establish the optimal therapeutic strategy for patients with a coronary artery disease (CAD) and chronically treated with clopidogrel 75 mg/day requiring co-administration of an anti-platelet treatment with P2Y12 antagonist and a PPI for treatment/prevention of GI ulceration.


Eligibility Criteria:
Inclusion Criteria :

* patient with stable Coronary Artery Disease (\< 3 months) treated with clopidogrel (75mg/d)
* Between 18 and 75 years of age
* Body Mass Index between 18 and 30 kg/m2 and body weight not less than 60 kg
* No major bleeding according to ISTH definition
* Subjects who signed an informed consent document
* Subjects who signed a separate pharmacogenomic informed consent document
* Subjects registered to the French national welfare system

Exclusion Criteria:

* Personal or family history of coagulation or bleeding disorders
* Use of known inhibitors or inducers of CYP2C19 and CYP3A including grape fruit juice intake
* Known hypersensitivity to lansoprazole, its excipients, or substituted benzimidazoles,
* Known hypersensitivity to clopidogrel / prasugrel
* Anti-platelet treatment other than clopidogrel + aspirin within 7 days before inclusion
* Any formal indication to maintain PPI treatment
* PPI within 15 days before inclusion in the study
* Active pathology with 10 days before inclusion
* Prior history of stent thrombosis
* Prior history of Stroke
* Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions

The goal of this study is to compare two formulations of Albendazole of the same dose in healthy adult participants. Researchers will compare the extent and rate to which the drug is absorbed.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy, non-smoker, adult participants having body mass index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kilogram (kg)/ height in meter square (m2)
2. Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead electrocardiogram (ECG) and X-ray chest (postero-anterior view) recordings.
3. Able to understand and adhere to the study procedures
4. Voluntary written informed consent is given for study participation
5. In case of female participants:

Surgically sterilized at least 6 months prior to study participation;Or If of childbearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study, And Serum pregnancy test must be negative.

Exclusion Criteria:

1. Known hypersensitivity or idiosyncratic reaction to albendazole or any excipients or any related drug or any substance.
2. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
3. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or non-steroidal anti inflammatory drugs (NSAIDs) induced urticaria.
4. History or presence of seizure or psychiatric disorders.
5. Ingestion of a medication (prescribed medication \& over the counter (OTC) medication, herbal remedies, cimetidine, praziquantel, dexamethasone, ritonavir, phenytoin, carbamazepine, phenobarbital) at any time in 14 days prior to dosing and any vaccine (including COVID-19 vaccine) from 14 days prior to dosing. In any such case participant selection will be at the discretion of the Principal Investigator.
6. Receipt of an intervention or participation in a drug research study within a period of 90 days prior to the first dose of study intervention \*\*.

   * If intervention is received within 90 days where there is no blood loss except safety lab testing, participant can be included considering 10 half-lives duration of intervention received.
7. A positive hepatitis screen including hepatitis B surface antigen and/or hepatitis C virus (HCV) antibodies.
8. A positive test result for HIV antibody (1 and/or 2).
9. The presence of clinically significant abnormal laboratory values during screening.
Immediate Anterior Chamber Paracentesis With A 30-Gauge Needle for Acute Primary Angle - Closure

This study was to evaluate the efficacy and safety of immediate anterior chamber paracentesis (ACP) with a 30-gauge needle as an initial treatment for acute primary angle closure (APAC).

This is a prospective study from patients with APAC presenting at the Faculty of Medicine Siriraj Hospital, Bangkok, Thailand in 2005. At presentation, patients received immediate ACP with a 30-gauge needle. The IOP, best corrected visual acuity (BCVA), corneal edema grading, pupil size and symptoms were recorded at immediately, 15 and 30 minutes, and then 1, 24 and 48 hours after paracentesis. All affected eyes received antiglaucomatous medications 60 minutes after ACP and underwent peripheral iridotomy within 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* patients aged more than 18 year old with the first attack of APAC
* IOP of more than or equal to 40 mmHg.

Exclusion Criteria:

* patient unable to cooperate for paracentesis
* patients with APAC in the only remaining eye
* patients received any glaucoma treatments prior to the study
* patients with secondary causes of acute angle closure
* patients with intraocular inflammation or infection; (6) patients with APAC in the eye with a history of previous intraocular surgery
* patients known hypersensitive to tetracaine hydrochloride or tobramycin.