bioihbjkbjnl/mcl2 huggingface dataset:
Understanding Treatment Response With Naltrexone Among White Alcoholics
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study involving treatment for alcohol dependence among males of European or Asian
      decent. The ultimate aim of this line of investigation is to further establish a genetic link
      between alcohol dependence and treatment by defining an endophenotype associated with
      treatment response. The study consists of two inpatient alcohol challenge sessions with
      treatment using random assignment to either naltrexone or placebo.
    

Detailed description: 
      Despite the well-established efficacy of naltrexone, there are significant variations in
      individual responses to naltrexone. A critical question remains: under what circumstances and
      for which patients will naltrexone be most beneficial? Recent work at our center provides
      evidence that the mu-opioid receptor (OPRM1) gene polymorphism A118G (Asn40Asp) imparts a
      significant change in treatment response. We have shown that patients with Asn40 variant
      (absence of heavy drinking -73.9% v/s 49% response). To further consolidate our knowledge, we
      wish to test the relationship between A118G polymorphism and the subjective/objective
      measures to alcohol among alcoholics treated with naltrexone. This work is focused on
      subjects of European or Asian decent as the A118G polymorphism occurs in less than 1% of
      those of African decent.

      Up to 40 subjects will be recruited. The subjects were admitted to the UPenn Translational
      Research Center and receive two alcohol challenge sessions after pretreatment with naltrexone
      or placebo.
    

Intervention name(s): Placebo Oral Tablet; Naltrexone
Intervention type(s): Drug; Drug
Intervention description(s): Placebo pill; 50 mg of naltrexone prior to challenge session
Other intervention name(s): Placebo
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Groups 1 and 3 get placebo in session 1 and placebo in session 2, Groups 2 and 4 get placebo in session 1 and naltrexone in session 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Outpatient Care for Multiparas After Elective Cesarean Section: an Observational Study
Condition: Outpatient Care
Study type: Observational [Patient Registry]

Summary: 
      The purpose of the study is to evaluate whether outpatient cesarean section can be performed
      in multiparous women without significant decrease in the parents' sense of security .
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        multiparas having a elective cesarean section at Herning hospital
      
Keywords: outpatient care; videoconferencing; elective cesarean section
Detection of Heterogeneity in Central Lung Cancer - EBUS-TBNA and ctDNA Analysis vs. Endobronchial Forceps Biopsy
Condition: Lung Neoplasms
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      Study participants will be selected from clinical routine patients with endobronchial
      infiltration of a central lung cancer and indication for bronchoscopic sampling.

      Consented patients will undergo bronchoscopy for tumor sampling applying two routine sampling
      methods during one single procedure (EBUS-TBNA and conventional forceps sampling). The
      sequence of both sampling methods will be randomized in advance.

      The resulting tissue samples will be analyzed by a pathologist using multiplex PCR and FISH.
      The corresponding analysis results will be compared between sampling methods.

      Assignment of a subject to a particular therapeutic strategy is not influenced by this
      protocol. Medicinal products will be used according to current practice and marketing
      authorisation.
    


Intervention name(s): EBUS-TBNA; Endobronchial forceps biopsy
Intervention type(s): Procedure; Procedure
Intervention description(s): Endobronchial ultrasound guided transbronchial needle aspiration; Conventional endobronchial forceps biopsy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic
      Dermatitis patients.
    

Detailed description: 
      PAC-14028 Cream (0.1%, 0.3%, 1.0%) or placebo will be treated to Mild to Moderate Atopic
      Dermatitis patients twice daily for 8 weeks.
    

Intervention name(s): PAC-14028 cream 0.1%; PAC-14028 cream 0.3%; PAC-14028 cream 1.0%; PAC-14028 cream vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Topical application; Topical application; Topical application; Topical application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Antiseizure Medication on Hormone Levels and Sexual Function in Men With Epilepsy
Condition: Seizure Disorder; Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Observational

Summary: 
      The purpose of this study is to determine if antiseizure drugs affect hormone levels and
      sexual function in men with seizures.
    

Detailed description: 
      This study involves donating two small tubes of blood for hormonal testing, which will be
      drawn at the same time as your routine blood draw for the monitoring of your antiseizure
      medication. You will also be asked to fill out a short confidential questionnaire regarding
      your sexual interest and function.
    

Time perspective: Other
Keywords: Seizure Disorder; Hypogonadism; Sexual Function; Epilepsy
THE EFFECT OF CREATIVE DRAMA ON THE DEVELOPMENT OF ANXIETY, EMPATHY AND COMMUNICATION SKILLS IN NURSING EDUCATION
Condition: Psychiatric Nursing
Study type: Interventional

Summary: 
      This work; The aim of this study is to determine the effect of the education program, which
      was created with the creative drama method based on Travelbee's "human-to-human relationship"
      theory, on the teaching and practice of mental health and psychiatric nursing course, on
      reducing the anxiety of students and improving their empathy and communication skills.
    

Detailed description: 
      In psychiatric nursing education; It is known that classical education methods are not
      sufficient to reduce students' anxiety and stigma, and to strengthen communication and
      empathy. For this reason, there is a need for training methods that will increase in-depth
      learning and communication skills and empathy in the field. In this research, the creative
      drama education method was arranged in accordance with the requirements of mental health and
      psychiatric nursing education and a training program was developed. Within the scope of the
      research, this training program was applied to the students who completed the theoretical
      education of psychiatric nursing. In order to measure the effectiveness of the research
      training program, it was planned in a quantitative design as a randomized controlled
      intervention study and in a mixed method in qualitative design in order to examine students'
      views on the method.
    

Intervention name(s): creative drama
Intervention type(s): Behavioral
Intervention description(s): In the training program, a total of six games were played about the experiences of psychiatric patients. The program was designed to be two game per week for four weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: it was planned in a quantitative design as a randomized controlled intervention study and in a mixed method in qualitative design in order to examine students' views on the method.
Masking: None (Open Label)
Primary purpose: Other
Keywords: psychiatric nursing ,creative drama, empathy, Anxiety
Effect of rHDL on Atherosclerosis - Safety and Efficacy: THE ERASE TRIAL
Condition: Acute Coronary Syndromes
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Currently available therapies to treat Acute Coronary Syndromes(ACS) have several limitations
      including; the relatively long treatment duration required before apparent significant
      benefit; the inability to achieve reversal of the atherosclerotic process; and poor patient
      compliance due to chronicity of therapy. This study will assess the effects of rHDL compared
      with placebo on indices of atherosclerosis progression and regression as assessed with
      intravascular ultrasound (IVUS) in patients after acute coronary syndromes (ACS).
    


Intervention name(s): rHDL
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Single Dose Study to Determine the Excretion, Balance and Metabolic Disposition of Radiolabelled GW642444.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterise the metabolic disposition of radiolabelled
      GW642444 when administered orally.
    

Detailed description: 
      This will be a single-centre, open-label, single-dose study to characterise the metabolic
      disposition of oral [14C]GW642444. Six healthy male subjects will be enrolled to ensure at
      least four fully evaluable subjects. Each subject will receive a single 200μg oral dose of
      GW642444 containing 2 μCi (0.074MBq) of [14C]GW642444. Whilst subjects are inhouse, blood,
      urine and faecal samples will be collected for a minimum of 168 hours after dosing (7 days)
      or for up to 240 hours (10 days) depending on amounts of radioactivity still being excreted
      after Day 5. Faecal sample collection may continue at home for up to 14 days. Bile samples
      will be collected using Entero-Test string sampling of duodenal bile. Plasma will be prepared
      from blood at various sample times after dosing to measure parent drug and total
      radiolabelled drug-related material. Urine and faeces aliquots will be taken to measure total
      radiolabelled drug-related material. Samples of urine, faeces, plasma and bile will be
      transferred into a separate study to characterise and, where feasible, quantify metabolites
      in these matrices. Safety and tolerability will be assessed by blood pressure, heart rate,
      12- lead electrocardiogram (ECG), clinical laboratory safety tests, and collection of adverse
      events (AEs).
    

Intervention name(s): [14C]GW642444
Intervention type(s): Drug
Intervention description(s): Single 200μg dose of [14C]GW642444 given on Day 1.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Accelerator Mass Spectrometry (AMS); Beta-2 agonist; Absorption, Distribution, Metabolism and Excretion (ADME); Radiolabel
New Horizons for the Treatment of Cardiomyopathy in Children
Condition: Cardiomyopathy
MeSH terms: Cardiomyopathies
Study type: Interventional

Summary: 
      Collecting mono nuclear cells from the patient's blood after a course of granulocyte
      stimulation then injecting them into the weak heart muscle measuring the heart function at
      the beginning and after 2.4.6 months to assess the improvement due to this procedure, by
      comparing these patients to patients with the same condition treated the classic way.
    

Detailed description: 
      Dilated cardiomyopathy in children has high morbidity and mortality, current treatment
      doesn't improve the prognosis and the only cure available is heart transplantation which is
      limited, has long waiting list (if available), high cost, and has many side effects, leading
      to the need of novel effective, less costly therapeutic alternatives.

      Stem cell therapy has proven to improve the cardiac function, reverse the pathologic
      histological changes, decrease the morbidity and mortality, offering a possible replacement
      to heart transplantation, different reports proved the safety and efficacy of this therapy
      using different types of cells and different routs of application in cardiomyopathy and acute
      myocardial infarction in children and adults, and in congenital heart disease, but the
      published cases of this therapy conducted on children with dilated cardiomyopathy are scanty
      .
    

Intervention name(s): mono nuclear cells injection; Digoxin+furosemide+captopril
Intervention type(s): Biological; Drug
Intervention description(s): trans endocardium injection of autologous mono nuclear cells for the intervention group and classic treatment for the control group; classical heart failure medical treatment
Other intervention name(s): lasix,capoten
Intervention MeSH terms: Digoxin; Captopril; Furosemide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dilated; Cardio-myopathy; pediatric; mono; nuclear; cells
A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Condition: Relapsed or Refractory Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with
      lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered
      twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects
      with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy.
    


Intervention name(s): Carfilzomib; Carfilzomib; Lenalidomide; Dexamethasone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Once weekly IV over 30 minutes on day 1, 8 and 15 of each 28 day cycle. The dose will be 20 mg/m2 on cycle 1 day 1 and 56 mg/m2 beginning with cycle 1 day 8 and thereafter. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent.; Twice weekly IV over 10 minutes on day 1, 2, 8, 9, 15 and 16 of each 28 day cycle. The dose will be 20 mg/m2 on cycle 1 days 1 and 2 and 27 mg/m2 beginning with cycle 1 day 8 and thereafter. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent.; Once daily orally 25 mg days 1 to 21 of each cycle. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent; Once daily orally or by IV 40 mg days 1, 8 and 15 of each cycle. Also day 22 of cycles 1 to 9. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent
Intervention MeSH terms: Dexamethasone; Lenalidomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bone Marrow Cancer
Influence of Two Different Preloaded Intraocular Lens (IOLs) on Posterior Capsule Opacification
Condition: Cataract
MeSH terms: Cataract; Capsule Opacification
Study type: Interventional
Phase: Phase 4

Summary: 
      Studies showed that a sharp posterior optic edge of an intraocular lens (IOL) inhibits
      migration of lens epithelial cells in between posterior capsule and optic of the IOL and
      therefore reduces the rate of posterior capsule opacification (PCO). In present time most
      IOLs implanted have a sharp posterior optic edge. Due to differences in IOL production
      different IOLs have different rates of PCO.

      Progression in cataract surgery technique allow phacoemulsification through micro-incisions.
      Therefore there is need for IOLs that can be implanted through incisions of about 2.5 mm.

      This study investigates the effect of two different hydrophobic acrylic IOLs with a sharp
      posterior optic edge on the rate of PCO after implantation through a micro-incision. The
      results will be compared intraindividually.
    

Detailed description: 
      prospective, randomized, bilateral study with intraindividual comparison, implantation of a
      Polylens Y10 IOL in one eye and implantation of a Polylens Y30 in the contralateral eye.

      PCO rate will be detected at 1 year and 2 years.
    

Intervention name(s): cataract surgery
Intervention type(s): Procedure
Intervention description(s): cataract surgery with implantation of an IOL
Other intervention name(s): Polylens Y30 IOL, Polytech, Germany; Polylens Y10 IOL, Polytech, Germany
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: posterior capsule opacification; micro incision; sharp optic edge
Effects of Transcranial Magnetic Stimulation (TMS) and Cognitive Training for Alzheimer Patients
Condition: Alzheimer Disease, Early Onset
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      Current diagnosis of Alzheimer disease is made by clinical, neuropsychological, and
      neuroimaging assessments. Routine structural neuroimaging evaluation is based on nonspecific
      features, such as atrophy, which is a late feature in the progression of the disease.
      Therefore, developing new approaches for early and specific recognition of Alzheimer disease
      at the prodromal stages is of crucial importance.

      In the present study the investigators would like to examine if combined treatment with TMS
      and cognitive training (CoTra) for several weeks can produce a sustained improvement in
      cognitive and behavioral symptomatology of Alzheimer's disease (AD) patients. A number of in
      vivo neuroimaging techniques, which can be used to reliably and noninvasively assess aspects
      of neuroanatomy, chemistry, physiology, and pathology, hold promise.
    


Intervention name(s): TMS stimulation; Sham comparator; Cognitive training
Intervention type(s): Device; Device; Behavioral
Intervention description(s): TMS stimulation and cognitive training; Sham comparator; TMS stimulation and cognitive training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Alzheimer; TMS; cognitive training
Proyecto SOL: A Risk Reduction Intervention for Hispanic Men Who Have Sex With Men (MSM)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The purpose of this project is to determine the acceptability, feasibility, and the
      preliminary efficacy of an HIV prevention behavioral intervention (Proyecto SOL) to reduce
      behaviors associated with HIV acquisition among Hispanic men who have sex with men (HMSM).
      The primary goal of the intervention is to motivate and assist participants in forming and
      carrying out a "Safer Options for Life" plan, thereby reducing their risk of HIV acquisition
      or transmission.
    


Intervention name(s): Proyecto SOL; HCT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Group intervention; Offer of HIV counseling and testing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV risk behavior; Unprotected sex; men who have sex with men; gay; Latino; Unsafe Sex
Integrating Depression Care in Acute Coronary Syndromes Care in China
Condition: Acute Coronary Syndromes; Depression
MeSH terms: Acute Coronary Syndrome; Syndrome; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The overall goal of this study is to develop, pilot test, implement, and evaluate a
      nurse-coordinated depression care model integrated into the care of Acute Coronary Syndromes
      (ACS) patients with rigorous assessment of feasibility, effectiveness, acceptability and cost
      in rural China. This study is a large multi-center, randomized clinical trial among 4,000 ACS
      patients from 20 rural county hospitals selected from a well-established research network
      across China.
    


Intervention name(s): Integrated care
Intervention type(s): Other
Intervention description(s): an integrated care model for ACS and depression delivered by a collaborative team composed of cardiologists/internists and nurses in the same rural county hospital. The collaborative team will be able to provide medical services for the diagnosis and treatment at acute phase of ACS during hospitalization, ACS secondary prevention therapies at and after discharge, and screening and treatment of depression depressive symptom during hospitalization and after discharge. The core of the interventions includes: depressidepressive symptomon screening and classification, individual counseling and medical treatment of depression, group counseling and health education, and follow-up for ACS and depression treatments compliance, IT- system- assisting theassisted management and necessary referral.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Health Services Research; Acute Coronary Syndromes; Depression; Integrated care
Zika-Vaccine Dose Finding Study Regarding Safety, Immunogenicity and Tolerability (V186-001)
Condition: Zika Virus
MeSH terms: Zika Virus Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in
      48 healthy volunteer subjects.

      After completion of screening procedures, the subjects are randomized to one of four
      treatment groups (different dosage strengths and placebo) All subjects will receive study
      treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with
      two vaccinations will receive a second treatment at day 28.

      Subjects will return on day 56 for the final visit.
    


Intervention name(s): MV-ZIKA; Placebo
Intervention type(s): Biological; Other
Intervention description(s): MV-Zika vaccine; physiological saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to demonstrate the efficacy and safety, and to assess the
      pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with
      moderate to severe ulcerative colitis (UC).
    


Intervention name(s): Adalimumab; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Subcutaneous (SC) injection; Subcutaneous (SC) injection
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative Colitis; adalimumab