cyrilzakka/clinical-trials huggingface dataset:
A Trial of Connecting to Promote Foster Teen Well-Being

This study evaluates the efficacy of a self-directed parenting program called Connecting in reducing risk of substance use and other risky behaviors in young foster teens (ages 11-15). Half of the participants will receive services as usual from the foster system, while half will participate in the Connecting program. Connecting is a 10-week, self-directed parenting workbook with two digital video discs (DVDs). Families receive weekly telephone support as they complete the program.


Eligibility Criteria:
Inclusion Criteria:

* Foster youth ages 11-15 years
* In current placement 60+ days
* In relative/suitable adult care, in licensed relative/suitable adult care, in licensed foster care, in dependency guardianship
* Caregiver and teen speak English well enough to use the program manual and respond to survey questions

Exclusion Criteria:

* The teen has regularly used drugs or alcohol in the last 30 days
* The teen has been involved in the criminal justice system
* The placement is not viewed as stable
* The caregiver is not committed to a long-term placement
* The teen will not likely be in the placement for at least 6 months
* Group home placements and behavioral rehabilitative services placements
Pre-exposure Prophylaxis Accessibility Research and Evaluation 2

This study is a controlled, un-blinded, two-arm, randomized (1:1) clinical trial to determine if providing high-risk subjects with a calculated risk score changes the likelihood of pre-exposure prophylaxis (PrEP) uptake.

All men who have sex with men (MSM) and male-to-female transgender individuals who have sex with men who present to TNC for HIV testing and are at risk for HIV will be offered enrollment in this study (see study schema). Upon enrollment, subjects will be given an Ipad-based computerized questionnaire that assesses their risk perception, demographics, risk behavior, and perception of whether they are a candidate for PrEP. Upon completion of the survey they will be randomized into 1 of 2 arms. Subjects in the intervention arm will receive the results of their risk score based on a risk calculator developed at UCSD and the Center for Disease Control and Prevention's tool for Assessing Risk for Contracting HIV (ARCH, formerly known as the HIV Incidence Risk Index for MSM, or HIRI-MSM), whereas subjects in the control arm will not receive this information. Both groups will receive standard risk reduction counseling. Subjects will be contacted by phone 2 months after enrollment to determine whether they initiated PrEP or not, to re-assess their risk perception, and to provide a link to a final online survey. If subjects have not completed the survey 4 weeks after being provided with the link, they will receive a text-message reminder.

The analysis of the data will begin 12 weeks after the last study subject is enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Man or transgender M to F who has sex with men.
* Age 18 years or older.
* Subjects must have substantial ongoing risk of acquisition of HIV as evident by one or more of the following: One or more episode of unprotected anal intercourse with a HIV-infected partner or a partner with unknown HIV status within the last 6 months
* Negative for HIV infection by rapid HIV test

Exclusion Criteria:

* Unable to give informed consent.
* Signs or symptoms suggestive of acute HIV infection
* Any other reason or condition that in the opinion of the investigator would interfere with participation, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses

The primary objective of this study is to evaluate the performance of the enVista Toric 0.9D vs non-Toric IOL.

The performance of the enVista Toric IOLs will be compared with that of enVista non-Toric (spherical) IOL. At least 384 eyes (n= 192 per lens type) from 3-4 Canadian centers will be investigated.

This is a retrospective chart review for preoperative and postoperative data conducted at least 4 weeks after IOL implantation.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females subjects age 18 or older on the date of surgery
* Implant of enVista Toric IOL and/or enVista non-Toric (spherical) IOL in at least one eye
* Data available at least 4 weeks after IOL implantation
* Eyes must qualify for the 0.9D toric lens based on the Barrett Toric Calculator (flipped axis must be less than 0.2D) (https://ascrs.org/tools/barrett-toric-calculator)

  * Study eyes were implanted with the 0.9D toric lens
  * Control eyes were not implanted with the 0.9D toric lens and implanted with a spherical (non-toric) equivalent instead

Exclusion Criteria:

* History of uncontrolled or clinically significant ocular comorbidities for the treated eye(s) before the surgery (e.g., dry eyes, retinal pathology, etc.)
* BCDVA of 20/25 or worse for the treated eye(s) after the surgery
* Excessive IOL rotation \> 10 degrees (Toric IOLs only) for the treated eye(s) after the surgery
Patient Education Program and Ehlers-Danlos Syndrome

The Ehlers-Danlos Syndrome (SED) comprises a group of clinically and genetically heterogeneous, inherited connective tissue diseases. The hypermobility type is the most frequent. It is characterized by a generalized joint hypermobility and a hyperextension skin.

Chronic pain syndrome is often present. Its psychological impact can be significant (anxiety, depression, impact on the quality of life of the patients). The disease also requires changes and a permanent adaptability (coping). It can lead to feelings of isolation and misunderstanding.

The French association of the Ehlers-Danlos Syndromes and the rehabilitation center of the 'Croix-Rouge Française des Massues' propose a patient education program for the patients with a hypermobility type SED (the PrEduSED program). This education program is open to patients and their caregivers located in France.

The research hypothesis is that the PrEduSED program improves their coping and reduces patient anxiety at 6 months (these are the two clinical criteria on which the PrEduSED could have the most impact, given the results of the first sessions).


Eligibility Criteria:
Inclusion Criteria:

Patients

* adults (\>18 years)
* hypermobility type Ehlers-Danlos Syndrome
* participating to one education session during the study period

Caregivers

* adults (\>18 years)
* caregivers of patients with hypermobility type Ehlers-Danlos Syndrome
* participating to one education session during the study period
Understanding Local Determinants of Cardiovascular Disease and Diabetes

Cross-sectional survey of all adults residing in two defined geographical regions in urban Lilongwe and rural Karonga District. Participants were interviewed, had anthropometric measures taken, and had fasting blood specimens taken.


Eligibility Criteria:
Inclusion Criteria:

* all adults over 18 self-identifying as normally resident in the pre-defined geographical areas

Exclusion Criteria:

* None
Follow-up After Surgery for Colon Cancer. General Practice vs. Surgical-based Follow-up?

The purpose of this study is to clarify cost effectiveness and quality of life issues among colon cancer patients followed up in a hospital setting or by their GP's.Statement of study hypothesis:Postoperative follow up of colon cancer patients (according to national guidelines) by general practitioners will not have any influence on patients' quality of life. There will not be observed any increase in serious clinical events and cost effectiveness will be improved.


Eligibility Criteria:
Inclusion Criteria:

* Surgery for colon cancer (including rectosigmoid) with histological grade Duke stages A, B or C.
* Completion of postsurgical chemotherapy (Dukes stage C patients).
* Informed consent.

Exclusion Criteria:

* Patients with rectal cancer defined as cancer within 15 cm from anus.
* A poor health status or operative complications making it natural to perform follow up by specialists.
* Additional cancer diagnoses.
* Disseminated cancer.
* Poor mental status.
Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

The purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for Helicobacter Pylori.

This study intends to select the patients with Hp infection in 13 tertiary hospitals across our country, and randomly give the three therapies to compare the eradication rate, compliance, the rate of adverse events, so as to provide some advices for the selection of appropriate eradication therapy, then collect an efficient, convenient and safe therapy for patients with H.pylori infection.

Before receiving the treatment plan, general information and relevant medical history of the subjects were collected through electronic questionnaires.The experimental data will be collected and recorded through follow-up by phone or WeChat during the experiment.

Eligibility Criteria:
Inclusion Criteria:

1. Ages between 18 and 70 years; Sexes eligible for study: both;
2. patients who are diagnosed with Helicobacter pylori with 13C urea breath test or 14C urea breath test;
3. treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months;
4. voluntary to be involved in the study and written informed consent was obtained from all patients

Exclusion Criteria:

1. allergic reactions to the study drugs;
2. patients with peptic ulcer;
3. patients who underwent eradication therapy for Helicobacter pylori during the last six months;
4. patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment;
5. patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
6. patients who have history of esophageal or gastric surgery;
7. pregnant or lactating women;
8. patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
9. Alcohol abusers
10. MALT lymphoma of stomach or malignant tumor
Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction (VITDAMI)

To study the effect of calcifediol on left ventricular remodeling, mineral metabolism, plasma levels of several prognostic biomarkers and on endothelial function after an anterior myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 40 years and maximum 85 years.
* Anterior myocardial infarction
* Sign informed consent

Exclusion Criteria:

* Death during the index event
* Age younger than 40 or older than 85 years
* Previous Infarction
* More than 7 days in hospitalization
* Systemic inflammatory or autoimmune disease
* Concomitant disorders limiting survival
* Concomitant cardiomyopathy
* Left ventricular hypertrophy \> 16mm in females and \> 17mm in males
* eGFR\<45
* LVEF\<30
* Incomplete revascularization
* Valvular prosthesis
* Aortic stenosis with mean gradient\> 25 mmHg
* Moderate or severe valvular regurgitation
* Hypersensitivity or intolerance vitamin D supplement o excipient
* Blood Calcium \>10.5 mg/dl
* Inability to follow.
* Difficulty in treatment compliance
* Contraindication for MRI, including indication to place a cardiac device
* Indication of therapy with vitamin D. Patient desires to take vitamin D.
* Drugs or conditions that interfere with the pharmacokinetics of calcifediol
A Study to Evaluate SHR-1210 in Subjects With Advanced HCC

This a randomized controlled Phase 2/3 study to evaluate the efficacy and safety of SHR-1210 in subjects with advanced HCC who failed or intolerable to prior systemic treatment. The primary study hypothesis is that SHR-1210 treatment improves Objective Response Rate and Overall Survival when compare with SOC.

In June 2017, this study was revised to expand the Phase 2 part to enroll more subjects and remove the Phase 3 part under the same protocol. A Phase 3 study will be initiated separately.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed HCC in advanced stage; not suitable to surgery or local regional treatment; with at least one measurable lesion per RECIST 1.1
2. Failed or intolerable to at least one prior systemic treatment for advanced HCC
3. ECOG Performance Status of 0 or1
4. Child-Pugh Class A or B with 7 points
5. Life Expectancy of at least 12 weeks
6. HBV DNA\<500 IU/ml
7. Adequate organ function
8. Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 60 days for female subjects and 120 days for male subjects after the last dose of study drug

Exclusion Criteria:

1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
2. Known liver transplant or plan to transplant
3. GI hemorrhage with 6 months
4. History or current brain metastases
5. Active known, or suspected autoimmune disease
Dose Dependent Effects of tDCS on Post-Operative Pain

The proper control of acute and chronic pain is one of the most important areas in health care. Despite the profound advances in neuroscience over the past 20 years, the investigators still largely use opiate narcotics, much as was done in the Civil War. Total knee arthroplasty (TKA) is one of the most common orthopedic procedures performed 1. While knee pain is often a complaint that precedes TKA, the procedure itself is associated with considerable post-operative pain lasting days to weeks. Adequate postoperative pain control is an important factor in determining recovery time and hospital length of stay. New analgesic strategies are needed that can be used adjunctively to existing strategies with the potential to reduce reliance on opioid analgesia. Several novel brain stimulation technologies including transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) are beginning to demonstrate promise as treatments for a variety of pain conditions. Electricity has no metabolite or other residue, and can be delivered with minimal discomfort and without problems associated with drug-drug interactions. In two independent preliminary pilot studies, the Investigators have shown that tDCS can reduce post-operative PCA use by as much as 46% while simultaneously reducing subjective pain ratings. The present study aims to determine the effects of transcranial direct current stimulation (tDCS) on post-operative pain, patient-controlled analgesia (PCA) use, and post-surgical complications during the 48-hour post-operative period following total knee arthroplasty.

The proposed study employs a randomized, double-blind, sham-controlled design to evaluate the effects of tDCS on pain among Veterans receiving unilateral total knee arthroplasty (TKA) and unilateral total hip arthroplasty (THA). Further, this study will examine dose-dependency of the tDCS analgesic effects. Each tDCS session delivered either 20 min of real or sham tDCS. Real tDCS was administered at 2mA whereas sham tDCS delivered none.

120 patients undergoing TKA will be randomly assigned to one of four groups:Group 1 will have 4 sessions of real tDCS, Group 2 - 2 sessions of real tDCS (+ 2 sham-sessions), and Group 3 - 1 session of real tDCS (+ 3 sham-sessions). Group 4 is "Sham" tDCS, which does not involve any real stimulation. The participants will receive 2 tDCS treatments on the day of their surgery, and 2 tDCS treatments the day after their surgery.

Eligibility Criteria:
Inclusion Criteria:

Participants will be 120 patients undergoing TKA or THA surgery at the Ralph H. Johnson VAMC in Charleston SC.

* Between the ages of 19 and 90
* Mentally capable of reading, writing, giving consent, and following instructions
* Cleared for and scheduled for unilateral TKA or THA surgery

Exclusion Criteria:

* Implanted medical devices above the waist
* Pregnant
* History of seizures
* Allergic to latex rubber
* Psychiatric conditions other than for depression and/or anxiety disorders
Identification of Genetic Markers Modulating Rhythmic Risk Among Patients With Severe Cardiomyopathy

The aim of this project is to identify common genetic polymorphisms associated with the occurrence of rhythmic events in patients with severe cardiomyopathy.


Eligibility Criteria:
Inclusion Criteria:

* Patients implanted for primary prevention, an implantable cardioverter defibrillator (ICD) single or double room, for severe cardiomyopathy (EF \<35%)
* Patients with ischemic cardiomyopathy or idiopathic dilated cardiomyopathy.- "Appropriate treatment" group: patients who had a rhythmic event (before or after inclusion) appropriately treated either by administering an electric shock or by antiarrhythmic stimulation
* Group "no event" patients who have never received treatment or electrical antiarrhythmic stimulation and with a minimum follow-up of three years before inclusion and did not receive proper treatment during the follow up period of the study

Exclusion Criteria:

* Patients implanted with an ICD for primary prevention in the context of a family hereditary disease (long QT syndrome, Brugada syndrome, hypertrophic cardiomyopathy, ventricular tachycardia catecholergic right ventricular dysplasia ...).
* Patients with left ventricular function greater than 35%.
* Patients implanted with a defibrillator function resynchronization.
* Patients minors, adults under guardianship and protected persons are eligible under this project.
Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)

The objective of this study is to confirm the long-term safety and reliability of the Linox Lead System as used with BIOTRONIK ICDs. The GALAXY registry will provide data to fully characterize ICD lead failures, from implant through 5 years, including those failures contributing to patients losing pacing or defibrillation therapy.

This study is a multi-center, prospective, non-randomized, 5-year data collection registry. Eligible patients must have been successfully implanted with a Linox Lead System connected to a BIOTRONIK ICD and consented and enrolled between 1-45 days following implant. This study is designed to be a post-implant (office-based) registry, and patients are meant to be seen according to each institution's standard of care, but not to exceed a follow-up time frame of every 6 months. At least 2000 patients will be enrolled in this registry, and each patient will be followed for five years post-implant.

Safety will be evaluated based on the analysis of the overall incidence of lead-related adverse events that require additional invasive intervention to resolve. In addition, each individual adverse event will be separately investigated. Lead parameters for sensing, pacing thresholds, and impedance will also be evaluated. An independent Clinical Events Committee will review and adjudicate all adverse events that occur during the study according to the protocol definitions.

Eligibility Criteria:
Inclusion Criteria:

* Successfully implanted Linox Lead System connected to a BIOTRONIK ICD, from 1-45 days prior to enrollment
* Able to understand the nature of the registry and provide informed consent
* Available for follow-up visits on a regular basis at the investigational site
* Age greater than or equal to 18 years

Exclusion Criteria:

* Enrolled in any IDE clinical study
* Planned cardiac surgical procedures or investigational measures within the next 6 months
* Expected to receive a heart transplant within 1 year
* Life expectancy less than 1 year
* Presence of another life-threatening, underlying illness separate from their cardiac disorder
* Pregnancy
* Inability to provide date of implant, devices implanted, age, gender, and whether the patient experienced any protocol-defined adverse events since implant
Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma

Optical coherence tomography guided laser treatment of basal cell carcinoma

The purpose of this pilot study is to examine the treatment basal cell carcinoma (BCC) with laser technology under the guidance of optical coherence tomography imaging (OCT). The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a non-ablative laser already shown to effectively treat BCC. Laser treatment of BCC has limited precedent in the literature, but the addition of OCT has the opportunity to enhance outcomes by better targeting the treatment and permitting more precise monitoring of clearance. We propose to use OCT imaging to guide the laser treatment to achieve optimal efficacy with minimized side-effects.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and carry out subject instructions or be represented by a legally authorized guardian or representative
* Ages 18 and older
* Seeks and is scheduled for treatment of a BCC previously confirmed with biopsy

Exclusion Criteria:

Any of the following will exclude participation in the study:

* Inability to understand and/or carry out instructions
* Patients with a BCC lesion that requires excision. This would include relatively large lesions (\>2.5 cm diameter), lesions that penetrate deep into the skin beyond the depth of the OCT image capture, high risk lesions as defined by the American Academy of Dermatology as recurrent and sclerosing subtype BCC, or metastases.
* Patients with periocular BCCs which might expose the patient to risk of damage to eyes from the laser.
* BCCs on legs due to their tendency towards poor wound healing.
* Pregnancy
* Patients unable to follow-up for the full 12 months.
Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer

The objective of this study was to compare the efficacy and safety of the combination therapy with enzalutamide + androgen deprivation therapy (ADT) and the combination therapy with flutamide + ADT in patients with castration resistant prostate cancer who had relapsed during combined androgen blockade (CAB) therapy with bicalutamide and ADT. This study also investigated the order of alternative antiandrogen therapy (AAT) by changing the 1st line medication after relapse of prostate-specific antigen (PSA).


Eligibility Criteria:
Inclusion Criteria:

* Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small-cell histology.
* Subject on continuous ADT with Gonadotropin Releasing Hormone (GnRH) agonist/antagonist or bilateral orchiectomy.
* Serum testosterone level below the target level at screening visit.
* Subject with asymptomatic or mildly symptomatic prostate cancer.
* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subject has progression of the disease as defined by rising PSA levels or progressive soft tissue or bony disease during CAB therapy in combination of bicalutamide and ADT.
* A sexually active male subject and the subject's female partner who is of childbearing potential must use 2 acceptable birth control methods from screening to 3 months after the last dose of the study drug.
* Subject must agree not to donate sperm from screening to 3 months after the last dose of the study drug.

Exclusion Criteria:

* Subject with severe concurrent diseases, infections, or complications.
* Subject with confirmed or suspected brain metastasis or active leptomeningeal metastasis.
* Subject with a history of malignant tumor other than prostate cancer in the past 5 years.
* Subject hypersensitive to the ingredients of enzalutamide capsules or flutamide tablets.
* Subject with a history of convulsive attack, or prone to convulsive attack.
* Subject with liver disorder such as viral hepatitis and hepatic cirrhosis, or subject with Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) at screening visit higher than the upper limit of normal.
* Subject received treatment for prostate cancer with cytocidal chemotherapy that includes anti androgenic agents other than bicalutamide, abiraterone, or estramustine.