bioihbjkbjnl/mcl2 huggingface dataset:
Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess the efficacy of vigabatrin for the treatment
      of cocaine dependence, based on the twice-weekly qualitative urine toxicologies for cocaine.
      Based on two prior unblinded human studies and 15 years of animal studies, this 100 subject
      double- blind, randomized study is designed to show if with vigabatrin treatment but not
      placebo, even non-hospitalized cocaine dependent individuals with ready access to cocaine
      will become cocaine abstinent if they are self motivated to stop their cocaine habit. To
      accomplish this, cocaine dependent subjects will be randomly assigned to either a placebo or
      vigabatrin treatment group and treated for a nine week period. The primary hypothesis is that
      as compared to the placebo arm, the vigabatrin treatment arm will show a significant increase
      in the number of subjects who are abstinent for the final 3 weeks of the study.
    


Intervention name(s): Vigabatrin; Placebo; Group therapy
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): crystalline drug dissolved in orange juice, dosage escalates from 500 mg twice daily to 1.5 g twice daily over a 3 week period. This dose is maintained for 4 weeks and then tapered to zero over the next two weeks; orange juice is administered twice daily in containers indistinguishable from the treatment arm.; Participants attend group sessions once a week
Other intervention name(s): Sabril; CPP 109; gamma vinyl GABA; GVG
Intervention MeSH terms: Vigabatrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vigabatrin; GVG; addiction; treatment; cocaine dependence
Asthma L-Citrulline Pilot Study
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This study will evaluate whether treatment with L-citrulline, which is an amino acid found in
      some foods, can increase levels of L-arginine and thereby restore the concentration of nitric
      oxide (NO) in the airways.
    

Detailed description: 
      Research has shown that some obese asthmatics have a metabolic imbalance in which L-arginine
      levels are reduced. L-arginine is an amino acid that is used to make NO, a gas that is
      normally made in the bronchi and ensures that the lungs function properly. In this pilot
      study subjects with asthma that have an increased body mass index compatible with being
      obese, will be invited to participate in a short open-label treatment with 15g/day of
      L-citrulline for two weeks. Study participants will be asked to do lung function testing and
      donate blood before and after taking the supplement. L-citrulline is safe and well tolerated
      and has been used at much higher doses without significant side effects.
    

Intervention name(s): L-Citrulline
Intervention type(s): Dietary Supplement
Intervention description(s): The purpose of this study is to see if citrulline supplementation will restore NO levels and lung function in subjects with asthma.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; L-citrulline
Measurement of MRP2 Function Using Urinary Coproporphyrins
Condition: Healthy Subjects
Study type: Observational

Summary: 
      Human Multidrug Related Protein 2 (MRP2) excretes several drugs and could therefore modulate
      their elimination. Individual's MRP2 activity is under genetic control. Thus it would be very
      useful to get an easily measurable biomarker reflecting individual's MRP2 activity. We aimed
      to investigate the ratio of urinary coproporphyrins I and III (UCP(I/I+III), known to be
      increased in patients with mutations in MRP2/ABCC2 gene.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        40 healthy subjects > 18 y 20 male, 20 female
      
Biospecimen description: 
      24h urine DNA
    
Keywords: Healthy
Effects of Triclosan-coated Sutures in Cardiac Surgery
Condition: Postoperative Wound Infection
MeSH terms: Infections; Wound Infection; Surgical Wound Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess if triclosan-coated sutures reduces wound infections
      after saphenous vein harvesting in CABG patients. Secondary objectives are the effect
      triclosan-coated sutures on sternal wound infections and a cost analysis.
    

Detailed description: 
      The role of the suture material for the development of postoperative wound infection has been
      debated for many years. It has been reported that fewer bacteria adhere to monofilament
      polypropylene than braided polyester sutures in vitro but the results are opposed by a
      non-randomized clinical study where the use of monofilament sutures was identified as an
      independent risk factor for leg wound infections after CABG.
    

Intervention name(s): Triclosan coated sutures
Intervention type(s): Device
Intervention description(s): Subcutaneous and cutaneous sutures coated with triclosan (Vicryl Plus / Monocryl Plus) are used to close the incisions after vein harvesting and sternotomy. All wounds are inspected before discharge from hospital and the patients are instructed to contact the study coordinator if any suspected infection occurs. In addition, all patients are controlled after thirty days by a nurse and contacted by telephone sixty days after surgery to assess postoperative infections by a predefined questionnaire. Infection symptoms are graded according to the Asepsis score and the CDC classification. Patient records including bacterial cultures and antibiotic treatment are collected for all patients with suspected infections.
Other intervention name(s): Monocryl Plus suture; Vicryl Plus suture
Intervention MeSH terms: Triclosan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Wound infection; SSI; Suture
PreHospital Air Medical Plasma Trial
Condition: Hemmorhagic Shock During Air Medical Transport
MeSH terms: Shock
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the effect of the prehospital infusion during air transport of 2 units of AB
      plasma on 30 day mortality in patients with hemorrhagic shock as compared to conventional
      care.
    

Detailed description: 
      Background: Although advances in the care of the severely injured patient have occurred over
      the last decade, patients continue to be plagued with uncontrolled hemorrhage resulting in
      significant early mortality and the development of multiple organ failure and associated
      complications. A primary driving force for this unbridled hemorrhage has been shown to be the
      early coagulopathy which complicates severe injury. Increasing evidence suggests that blood
      component transfusion protocols that address this early coagulopathy, once a patient arrives
      at a trauma center, are associated with lower mortality and a reduction in blood component
      transfusion requirements. Prehospital interventions which quell this early coagulopathy in an
      earlier setting have the potential to minimize or even prevent this vicious hemorrhagic
      cascade, further lowering blood component transfusion requirements and reducing the resultant
      morbid sequelae which complicates severe injury.

      Objective/Hypothesis: The primary hypothesis will be that prehospital infusion of plasma
      during air medical transport in patients with hemorrhagic shock will lower 30 day mortality.
      The secondary hypotheses include that prehospital infusion of plasma will reduce 24 hour
      blood transfusion, multiple organ failure, nosocomial infection, and acute lung injury,
      reduce or prevent the early coagulopathy as demonstrated by improving presenting coagulation
      and thromboelastography parameters, and reduce the early inflammatory cytokine response,
      thrombomodulin and increase protein C levels.
    

Intervention name(s): infusion of 2 units of plasma
Intervention type(s): Biological
Intervention description(s): infusion of 2 units of plasma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: hemmorhagic shock, plasma, air medical transport, randomized, multicenter
MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins
Condition: Greater Saphenous Vein Injury
MeSH terms: Varicose Veins
Study type: Interventional

Summary: 
      The newly developed Mechanochemical Endovenous Ablation (MOCA) device uses a technique that
      combines mechanical endothelial damage using a rotating wire with the infusion of a liquid
      sclerosant. Heating of the vein and tumescent anesthesia are not required; only local
      anesthesia is utilized at the insertion site. Previously we showed that endovenous MOCA,
      using polidocanol, is feasible and safe in the treatment of great spahenous vein (GSV)
      incompetence. However, larger studies with a prolonged follow-up to prove the efficacy of
      this technique in terms of obliteration rates are lacking. This randomized trial was designed
      to compare occlusion rate, post-operative pain and complications between radiofrequency
      ablation (RFA: the current treatment for GSV incompetence) en MOCA.
    


Intervention name(s): Mechanochemical Endovenous Ablation (MOCA); Radiofrequency ablation (RFA)
Intervention type(s): Device; Procedure
Intervention description(s): Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence; Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence
Other intervention name(s): (MOCA); (RFA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSV; Primary Varicose Veins; Great Saphenous Vein; Treatment
A 36-Week Extension to Protocol ISA04-03
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of voclosporin in patients
      with plaque psoriasis.
    

Detailed description: 
      Psoriasis is a chronic skin condition that can have a significant impact on patient's
      physical and mental well being. The most common form of psoriasis is plaque psoriasis.
      Targeted treatments in psoriasis have been reported recently, yet cyclosporine, a calcineurin
      inhibitor (CNi) remains one of the treatments which has the greatest efficacy. Voclosporin
      represents the possibility of a calcineurin inhibitor which is not only as efficacious as
      cyclosporine A, but also has an improved toxicity profile.
    

Intervention name(s): voclosporin
Intervention type(s): Drug
Intervention description(s): voclosporin 0.2, 0.3, or 0.4 mg/kg BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized Controlled Trials; Immunosuppression; Adult; Chronic Disease; Dermatologic Agents; Female; Humans; Male; Middle Aged; Severity of Illness Index; Treatment Outcome; Quality of Life; Double-Blind Method
Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110)
      combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B
      infection.
    


Intervention name(s): a mixed plasmid DNA (HB-110); Adefovir
Intervention type(s): Genetic; Drug
Intervention description(s): HB-110 2mg (or 4mg or 8mg), im, every other week, from week 0 to week 22 (total 12 injections) and Adefovir(Adefovir dipivoxil 10mg), od, from week -10 to from week 48.; Adefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48.
Intervention MeSH terms: Adefovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The eHealth Diabetes Remission Trial - Pilot Study
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Ten study participants will consume a low-calorie total diet replacement for 12 weeks, have a
      6-week food reintroduction phase (week 13-18) and continue with the weight loss maintenance
      phase until the end of the study (week 19-26). The weight loss goal is 15 kg (or 15% if body
      weight is bellow 80 kg). The primary study outcome iw weight loss after 6 months and the
      co-primary outcome is diabetes remission after 6 months (HbA1c < 48 mmol/mol). During the
      weight maintenance phase, if weight regain occurs or if HbA1c increases a rescue plan of
      total diet replacement will be recommended.

      The participants will be supplied with the total diet replacement Modifast free of charge.
      Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood
      pressure monitor. Participants will be advised to measure body weight, blood glucose and
      blood pressure every morning. The results are registered in the mobile phone application
      Telia Health Monitoring and are wirelessly transmitted to the project's physician, nurse and
      dietician. At the beginning of the food reintroduction phase the participants will receive an
      activity tracer and will be advised to increase their physical activity. Primary and
      secondary outcome measures will be estimated at the beginning and after 3 and 6 months. At
      the end of the study, all participants will take part in an individual semi-structured
      interview to investigate the participants' experience of diabetes remission and of the
      eHealth contact with the healthcare provider. After participants have completed the study,
      they will be followed at least once per year by obtaining data on blood sugar, HbA1c, body
      weight, blood pressure, medication usage and diabetes complications from the healthcare
      computer system.
    


Intervention name(s): Diabetes remission using total diet replacement and eHealth contact with the healthcare provider
Intervention type(s): Behavioral
Intervention description(s): Participants will replace usual foods with the commercially available total diet replacement Modifast (Impolin AB), which is delivered to them during the study period without any cost. Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor and will be advised to measure body weight, fasting blood glucose and blood pressure every morning. The results are registered in the mobile phone application Telia Health Monitoring (Telia Sweden AB) and are wirelessly transmitted to the study team.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes remission; weight loss; low-calorie diet; eHealth
Use of Noninvasive Brain Stimulation in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this research is to determine whether repetitive sessions of transcranial
      direct current stimulation (tDCS) to the prefrontal cortex can enhance the cognitive,
      affective and motor functioning of those with Parkinson's Disease.

      In this study we will compare active tDCS with sham tDCS. Each subject will receive two
      consecutive weeks of stimulation (Monday through Friday). A battery of neuropsychological and
      affective tests will be administered throughout the duration of the study.
    

Detailed description: 
      Note that this study is a two-center study (the other center is Beth Israel Deaconess Medical
      Center - PI - Alvaro Pascual-Leone)

      * Further study details are provided by Spaulding Rehabilitation Hospital.
    

Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Subjects will receive a total of 10 stimulation sessions on consecutive days, Monday- Friday for a total of two weeks. During each session, 2 mA of tDCS will be applied for 20 minutes over the left or right DLPFC (active or sham).
Other intervention name(s): tDCS, direct current stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Parkinson; Transcranial direct current stimulation; Motor function; Cognitive function; Affective function
Hybrid Closure of Congenital Heart Disease
Condition: Pediatric Ventricular Septal Defects
MeSH terms: Heart Septal Defects; Heart Septal Defects, Ventricular
Study type: Interventional

Summary: 
      Ventricular septal defect (VSD) is one of the most common pediatric congenital malformations.
      In recent years, in view of the rapid rise of transthoracic minimally invasive hybrid closure
      for pediatric VSD in the clinical practice, precision assessment of perioperative its
      effectiveness and safety has already become an important issue that must be solved. On the
      basis of echocardiography, integrating with characteristics associated critical care, the
      investigators focus on precision assessment of perioperative effectiveness and safety of
      transthoracic hybrid closure for pediatric VSD, compared with conventional surgical
      sternotomy repair with cardiopulmonary bypass (CPB).
    


Intervention name(s): sufentanil anesthesia; Hybrid closure; Control
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. During extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations.; Hybrid closure of ventricular septal defects through the delivery system without cardiopulmonary bypass by transthoracic minimally invasive small incision.; Surgical closure of ventricular septal defects with cardiopulmonary bypass by routine open thoracotomy.
Other intervention name(s): Sufentanil, Sufenta, (R-30730); TTMI: Transthoracic Minimally Invasive; CPB: cardiopulmonary bypass
Intervention MeSH terms: Sufentanil; Dsuvia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers
Condition: Hyperparathyroidism, Secondary
MeSH terms: Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the safety and tolerability of etelcalcetide in
      healthy young males.
    


Intervention name(s): Etelcalcetide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as a single intravenous (IV) injection; Administered as a single intravenous (IV) injection
Other intervention name(s): KAI-4169; AMG 416; Parsabiv™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Bariatric Surgery-Induced Shift in Gut Microbiome and NAFLD
Condition: Obesity; Diabetes Mellitus, Type 2; NAFLD
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This study is designed as a prospective pilot study for longitudinal assessment of fecal
      microbiome related to medical and surgical weight loss. The investigators follow the standard
      of care for perioperative and intraoperative management of study participants. The only
      addition to the standard of care protocol will be collection of fecal samples at 3 time
      points. This will enable investigators to compare changes in and effects by microbiota after
      low-calorie diet versus after bariatric surgery .
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants who are in the evaluation process for Roux-en-Y Gastric Bypass (RYGB) and
        Sleeve Gastrectomy (SG) will be offered the opportunity to volunteer for this study.
Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure
Condition: Gynecologic Surgical Procedures
Study type: Interventional

Summary: 
      Total laparoscopic hysterectomy is a procedure that is performed each time more often. One of
      the problems described for this procedure has to do with the closure of the vaginal vault,
      increased surgical time when suture laparoscopically, complications such as dehiscence of the
      dome, infections, hematomas and dyspareunia. A prospective study will be conducted to compare
      two different techniques for closure of the vaginal vault.
    


Intervention name(s): 2/0 barbed suture; 0/0 Vicryl suture
Intervention type(s): Other; Other
Intervention description(s): Close vaginal vault 2 planes with 2/0 barbed suture in patients with total laparoscopic hysterectomy in benign pathology; Close vaginal vault 2 planes with 0/0 Vicryl suture in patients with total laparoscopic hysterectomy in benign pathology
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Laparoscopy; Hysterectomy; Suture Techniques
The Effect of Exercises on Young Adults
Condition: Exercise; Young Adults; Quality of Life; Pain; Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      The aim of this study was to assess the treatment effect of plates and conventional exercises
      on health related quality of life, pain, functional level, psychological state in young
      adults. Randomised controlled study. Participants were randomly divided into 3 groups: a
      plates exercise group (n = 29), a therapeutic exercise group (n = 21), and a control group (n
      = 35). The therapeutic and plates groups underwent related training programs for 3 month,
      while the controls had no specific training. After demographic knowledge were collected the
      investigators carried out the following assessments on all participants: the Visual Analog
      Scale (VAS), Waist/ Hip ratio (WHr), Beck Depression Inventory (BDI), Oswestry Disability
      Index (ODI), Notthingham Health Profile (NHP). All subjects were evaluated at baseline and
      post-training.
    


Intervention name(s): training
Intervention type(s): Behavioral
Intervention description(s): plates and therapeutic exercises applied on young adults
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled
Masking: Single (Investigator)
Primary purpose: Prevention