cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients

The investigators plan to compare the effectiveness and cost effectiveness of an inpatient smoking cessation intervention for all smokers hospitalized at two urban public hospitals.

Our sites are: Bellevue Hospital Center (a New York City public hospital) and the Manhattan campus of the VA New York Harbor Healthcare System. During hospitalization, all smokers will receive usual care. At the time of discharge, patients will be randomized to one of two arms: multisession telephone counseling by their hospital's smoking cessation staff, or faxed referral to the state Quitline (which will then perform phone outreach as per Quitline protocol). All patients enrolled in the study will receive nicotine replacement therapy.

The primary aims are:

Aim 1: To compare the effectiveness of the intervention (proactive multisession telephone counseling by in-hospital staff) versus control ('fax-to-quit' Quitline referral).

Aim 2: To evaluate and compare the cost-effectiveness of these interventions from a societal perspective and from a payer perspective.

The secondary aims are:

Secondary Aim 1: To compare outcomes by race/ethnicity, immigrant status, inpatient diagnosis, and location of patient hospitalization Secondary Aim 2: To compare outcomes of the interventions at 6 and 12 months post-discharge Secondary Aim 3: To compare biochemically-verified abstinence rates at 6 months post-discharge Secondary Aim 4: To compare cessation outcomes between those who are known HIV-seropositive and those who are not, and explore possible mediators of cessation in HIV-seropositive patients

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* smoked tobacco during the prior 30 days
* have an active phone number
* provide consent in English, Spanish or Mandarin

Exclusion Criteria:

* Patients will be excluded if they use only smokeless tobacco or products such as betel (since there is not yet efficacy data for treating use of these tobacco products in the inpatient setting)
* are pregnant or breastfeeding
* are discharged to an institution (e.g. jail/prison, nursing home, long-term psychiatric facility).
Intervention to Improve Prescribing in Elderly Patients

This study tested the efficacy of an easy-to-use checklist aimed at supporting the therapeutic reasoning of physicians in order to reduce inappropriate prescribing and polypharmacy in elderly adults admitted to an internal medicine unit.

Background: Polypharmacy and inappropriate medication prescriptions are associated with increased morbidity and mortality. Most interventions proposed to improve appropriate prescribing are time and resource intensive and therefore hardly applicable in daily clinical practice.

Objective: To test the efficacy of an easy-to-use checklist aimed at supporting the therapeutic reasoning of physicians in order to reduce inappropriate prescribing and polypharmacy.

Design: single-center, interventional, quasi-experimental before-after study. Patients: Consecutive patients aged ≥65 years, hospitalized in the division of internal medicine of a Swiss secondary-level hospital from September to November 2012 (control group, N=450) and from September to November 2013 (intervention group, N=450).

Intervention: Introduction of a 5-point checklist to be used by all physicians on the internal medicine wards.

Main Measures: The proportion of patients with prescription of potentially inappropriate medications (PIMs) at discharge, according to Screening tool of older people's prescriptions (STOPP) criteria, and the number of prescribed medications at discharge, before and after the introduction of the checklist. Secondary outcomes were the prevalence of polypharmacy (≥ 5 drugs) and hyperpolypharmacy (≥ 10 drugs), and the prevalence of potentially inappropriate prescribing omissions (PPOs) according to START criteria.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients aged ≥65 years,
* patients hospitalized in the division of internal medicine of a Swiss secondary-level hospital from September to November 2012 (control group, N=450) and from September to November 2013 (intervention group, N=450).

Exclusion Criteria:

* none
LUPS-Lipids and Glucose Under Prospective Surveillance

Prospective, non-randomized cohort study to analyse genetic variations, dietary patterns, perceived stress and anxiety and early changes in lipid metabolism leading to the metabolic syndrome and type 2 diabetes

The LUPS-study is a collaboration between Asklepios Clinics Hamburg GmbH and University Clinic Hamburg Eppendorf, Germany. This study is assessing a multitude of serum biomarkers, anthropometrics, dietary habits, physical activity, perceived stress along with genetic information from "healthy workers" (25-60years) to better understand phenotype-genotype associations leading to MetS and type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* 25-60 years men and women willing to give consent

Exclusion Criteria:

* diabetes (type 1 or 2)
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986120 in Healthy Subjects and the Effects of Co-Administration of Midazolam and BMS-986120

The purpose of this study is to assess the safety, tolerability and effect on Midazolam pharmacokinetics of multiple oral doses of BMS-986120 in healthy subjects.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

1. Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
2. Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=Weight (kg)/\[Height(m)\]2
3. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men, ages 18 to 75, inclusive

Exclusion Criteria:

1. Concurrent, or use within 2-weeks of study drug administration, of marketed or investigational, non-steroidal anti-inflammatory compounds (NSAIDS), aspirin or other antiplatelet agents, oral or parenteral anticoagulants
2. Subjects at screening or prior to first dose with the following abnormal laboratory values upon repeat testing are excluded:

   * i) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>upper limit of normal (ULN)
   * ii) Total bilirubin \>ULN, thyroid-stimulating hormone (TSH) \>1.5 x ULN with T4 within normal limits (Subjects with mild unconjugated hyperbilirubinemia due to Gilbert's syndrome are excluded)
   * iii) CK \>3 x ULN (unless exercise related and CK-MB within normal limits)
   * iv) Activated partial thromboplastin (aPTT) or Prothrombin Time (PT)/International Normalized Ratio (INR) \>ULN
   * v) Blood urea nitrogen (BUN) or creatinine (Cr) \>ULN
3. Hemoglobin or hematocrit or platelet count \<lower limit of normal (LLN)
4. Bleeding time exceeding 8 minutes at pre-dose on Day -1
5. Subjects with micro- or macro-hematuria and/or fecal occult blood detected during screening, baseline or documented during other recent medical assessment, unless deemed not clinically significant by the Investigator and Medical Monitor
6. Any significant acute or chronic medical illness
7. Current or recent (within 3 months of study drug administration) gastrointestinal disease
8. Any major surgery within 12 weeks of study drug administration
Phase 1 Study of Levocetirizine

This is a single center, single blind, single dose, randomized, partial cross-over study to confirm bioequivalence between levocetirizine and cetirizine.


Eligibility Criteria:
Inclusion Criteria:

1. Japanese healthy male subjects aged between 20 and 64 years of age inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, and other tests.
2. Body weight ≥ 50 kg and BMI within the range 18.50-25.00 kg/m2 inclusive.
3. Non-smokers (at least 6 months).
4. Clinical laboratory tests data obtained at screening meet the following:

   AST(GOT), ALT(GPT), total-bilirubin, BUN, creatinine, uric acid,: below the upper normal range
5. Normal 12-lead EGC finding at screening; QTc interval \<450msec
6. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

1. The subject has any clinically relevant abnormality on medical examination, vital sign, clinical laboratory test or medical history at screening in the medical opinion of the investigator or the subject has a medical history that is not considered as eligible for inclusion in this study by the investigator.
2. The subject has an allergy for any drug or idiosyncrasy.
3. The subject has a history of allergic rhinitis.
4. The subject has a history or presence of clinically significant gastrointestinal, hepatic or renal disease or other condition known to interfere with absorption, distribution, metabolism or elimination of drugs.
5. The subject is currently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
6. The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.
7. The subject has a history or current conditions of drug abuse or alcoholism.
8. History of regular alcohol consumption exceeding on average, 14 drinks/week (1 drink = 150mL of wine or 360mL of beer or 45mL of 80 proof distilled spirits).
9. The subject is positive for urine drug screening.
10. The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody.
11. The subject has donated a unit of blood "\>400mL" within the previous 4 months or "\>200mL" within the previous 1 month.
A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis.


Eligibility Criteria:
Key Inclusion Criteria:

Inclusion Criteria for Non-Pustular Palmoplantar Psoriasis

* Men and women diagnosed with stable plaque psoriasis with involvement of the palm(s)and/or sole(s) for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
* Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1.
* Moderate-to-severe non-pustular PP psoriasis, defined as pp-PGA score of ≥ 3 on a 5-pointscale and pp-PASI ≥ 8 at both screening visit and Day 1.

  * A total maximum of 5 sterile pustules across both palms and soles limited only to psoriatic plaques will be allowed.
* Evidence of typical plaque psoriasis outside palms and soles at both screening visit and Day 1.
* Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
* Failed to respond to, or intolerant of ≥ 1 topical therapy.

Inclusion Criteria for Genital Psoriasis

* Men and women diagnosed with stable plaque psoriasis with involvement of the genital area for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
* Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1.
* Moderate-to-severe GenPs, defined as static Physician's Global Assessment of Genitalia (s-PGA-G) score of ≥ 3 on a 6-point scale at both screening visit and Day 1.
* Evidence of typical plaque psoriasis in a non-genital area at both screening visit and Day 1.
* Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
* Failed to respond to, or intolerant of ≥ 1 topical therapy.

Key Exclusion Criteria:

Target Disease Exceptions

* Has non-plaque psoriasis (for PP pustulosis, PP pustular psoriasis, isolated pustules on palms or soles with or without erythema outside psoriatic plaques, guttate, pustular, erythrodermic, and drug-induced psoriasis) at screening or Day 1.

Other protocol-defined inclusion/exclusion criteria apply.
RESCUE and REVERSE Long-term Follow-up

The goal of this clinical trial is to assess the long-term safety and efficacy of GS010, a gene therapy, and assess the quality of life in subjects with LHON due to the G11778A ND4 mitochondrial mutation and who were treated in the Rescue or Reverse studies.

Seven investigational centers from the RESCUE and REVERSE studies also participated in the RESTORE study, located in the European union and in the USA.

Primary objectives: to assess the long term safety of intravitreal injection up to 5 years of post treatment in subjects who were treated in the RESCUE or REVERSE studies.

Secondary objectives: (1) to assess the long-term efficacy of intravitreal GS010 administration up to 5 years post-treatment in subjects who were treated in the RESCUE or REVERSE studies; and (2) to assess the quality of life (QoL) in subjects who were treated with GS010 in the RESCUE or REVERSE studies for up to 5 years post-treatment.

Methodology: This was a Phase III prospective long-term follow-up (LTFU) clinical study of subjects previously treated with GS010 and Sham during 2 Phase III studies-RESCUE and REVERSE. The LTFU study followed subjects for an additional 3 years, for a total of 5 years post-injection. The LTFU study included 5 visits at 2, 2.5, 3, 4, and 5 years after the investigational medicinal product (IMP) injection. Safety, efficacy, and QoL variables were assessed during each of the 5 LTFU visits, and descriptive summaries and statistical testing were used for the analysis of the data.

This report presents the final analysis of results at Year 5 after treatment administration in RESCUE and REVERSE.

Number of analysed subjects: all subjects completing RECUE and REVERSE studies who provided consent for the RESTORE study: 62 subjects.

Eligibility Criteria:
Inclusion Criteria

* Subject was treated with GS010 IVT injection in either of the RESCUE or REVERSE Phase III clinical studies
* Subject of legal consent age has provided informed consent; subjects that are not of legal consent age have undergone their country-approved clinical trial enrollment consent process

Non-Inclusion Criteria

* Subject is unwilling or unable to comply with the protocol requirements
* Subject has any medical or psychological condition that, in the opinion of the Investigator, may compromise his or her safe participation in the study
* Subject is taking or intending to take idebenone during the long-term follow-up study period
Effectiveness of a CBT Based Mobile Application

This research aims to explore the effect of a mobile application designed on the basis of cognitive behavioral therapy on college students suffering from depression in terms of their symptoms, suicidal thoughts, and other relevant variables.

Background: College students encounter the transition from adolescence to adulthood, thereby possibly facing various factors causing depression. However, instead of consulting a professional, most college students seek help online or through contacts, or internalize their emotions. The current situation could be due to the low efficiency of depression prevention and the limited consultation provided at campus. While many studies have examined adopting mobile applications in dealing with depression, they have not shown consistent results. The cross-sectional research has been the most common; few randomized controlled trials have been conducted. Hence, much empirical evidence is needed to identify the effect of a mobile application.

Aim: This research aims to explore the effect of a mobile application designed on the basis of cognitive behavioral therapy on college students suffering from depression in terms of their symptoms, suicidal ideation, and other relevant variables.

Methodology: This is a randomized controlled trials study. The participants, aged 20 and above, were recruited from three universities of science and technology of similar nature. All of them suffer from depression symptoms and have used Wi-Fi smartphones. They were randomly assigned to the control group and the treatment group. The treatment group received an intervention involving the participants' use of the mobile application for 12 weeks, at least once a week, 20 minutes per session. The generalized estimating equation was adopted to analyze the results regarding the depression symptoms, suicidal ideation, help-seeking attitudes, emotional self-awareness, and mobile health (mHealth) literacy.

Expected outcomes: The results obtained by tracking the symptoms of depression from the empirical research design conducted on campus will provide a reference to understanding to what extent mobile applications could be an appropriate intervention for college students.

Clinical application: The research findings could provide insights for policymaking in respect of helping a person with depression on campus to better meet college students' needs.

Eligibility Criteria:
Inclusion Criteria:

* suffer from depression symptoms.
* aged 20 and above.
* being able to communicate in Chinese or Taiwanese.
* used Wi-Fi smartphones.
* Agree and obtain written consent.
* In the school term during research.

Exclusion Criteria:

* Have a full-time job.
* Who has been diagnosed with bipolar disorder, Asperger syndrome, and schizophrenia.
* Who have the health conditions associated with visual impairments, auditory impairments, and mobility impairments, that are limited to the use of accessibility mobile applications.
Mobile Health Application to Improve Patient Satisfaction After Urethroplasty

Create a custom urethroplasty mobile application that will guide patients through through the surgical process.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Have a Urethral stricture and are under going urethroplasty surgery

Exclusion Criteria:

* Patients that do not have mobile phone capabilities
* Patients who have physical or cognitive impairment when using a mobile phone or answering questionnaires
* Inability to provide consent to the study
Comparative Study of EDP-420 Versus Another Antibiotic in the Treatment of Community Acquired Pneumonia

This study will compare the efficacy, safety and tolerability of EDP-420 versus another oral antibiotic in the treatment of community acquired pneumonia


Eligibility Criteria:
Inclusion Criteria:

* Recent respiratory illness with signs and symptoms and chest X-ray consistent with the diagnosis of community-acquired pneumonia.
* Suitable candidate for oral antibiotic therapy and able to swallow large capsules intact
* If female, must be non-lactating and at no risk for pregnancy

Exclusion Criteria:

* Other infections
* Other pulmonary diseases requirement multiple antibacterial medications or long duration of therapy
* History of hypersensitivity, allergic or adverse reactions to macrolide, ketolide, azalide or streptogramins
* Evidence of uncontrolled clinically significant disease, malignancy, or other abnormality
* Requirement of parenteral antimicrobial therapy for treatment of pneumonia
* Currently receiving or likely to receive any known inhibitors or inducers of cytochrome P450 mediated drug metabolism
* Immunocompromised subjects
German Centre for Cardiovascular Research Cardiomyopathy Register

This is a joint project by Heidelberg University and Greifswald University.

Our objective is to establish an unique national multi-center registry and biobank of well phenotyped patients with non-ischemic cardiomyopathies (CMP) including in depth clinical, molecular and omics-based phenotyping to serve as:

1. central hub for clinical outcome studies.
2. joint resource for diagnostic and therapeutic trials.
3. common biomaterial bank.
4. resource for detailed molecular analyses on patients' biomaterials and patient specific model systems.

The following basic research projects, called modules, will be tied to and rely on the recruitment of CMP patients and the infrastructure provided by TORCH:

* Well phenotyped patients will be the starting point for comprehensive next-generation genotyping, leading to advanced estimates of genotype-phenotype relationship and its clinical impact.
* Functional analysis of novel genomic loci and their related molecular pathways will be based on our established in-vitro (e.g. iPS cells, yeast two hybrid) and in-vivo (e.g. zebrafish and mice) model systems.
* The integrated analysis of viral load and replication, inflammation, genotype and clinical variables will define risk variables for inflammatory and hereditary CMP.
* By longitudinal follow-up of patients, the role of genetic, epigenetic, metabolic, molecular biomarkers and histopathology for diagnosis and out-come prediction will be defined on a national level.

The registry will also facilitate investigator initiated clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary non-ischemic cardiomyopathies including hereditary and inflammatory dilated cardiomyopathy, left ventricular non-compaction cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and acute myocarditis.

Exclusion Criteria:

* Preexisting other cardiac diseases such as significant valvular, ischemic or pericardial disease; Severe arterial hypertension; Primary pulmonary artery hypertension; Chronic advanced disorders; History of treatment with cardiotoxic agents and chest radiation; Drug and alcohol abuse; Patients \<18 and \>79 years of age; Life expectancy less than 1 year due to non-cardiac comorbidity
A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)

This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years.
* Clinical diagnosis of nonsegmental vitiligo and meet the following:

  * T-BSA ≥ 5%
  * T-VASI score ≥ 4
  * F-BSA ≥ 0.5%
  * F-VASI score ≥ 0.5
* Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Other forms of vitiligo or skin depigmentation disorders.
* Clinically significant abnormal TSH or free T4 at screening.
* Use of laser or phototherapy within 8 weeks and dihydroxyacetone within 4 weeks prior to Day 1.
* Current or past use of the depigmenting agent monobenzyl ether of hydroquinone including Benoquin®.
* History of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo.
* Spontaneous and significant repigmentation within 6 months prior to screening.
* Women who are pregnant, considering pregnancy, or breast feeding.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or recurrent dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
* Evidence of infection with TB, HBV, HCV or HIV.
* History of failure to JAK inhibitor treatment of any inflammatory disease.
* Laboratory values outside of the protocol-defined ranges.

Other protocol-defined Inclusion/Exclusion Criteria may apply.