bioihbjkbjnl/mcl2 huggingface dataset:
Cocaine Withdrawal and Pharmacotherapy Response
Condition: Cocaine Dependence; Opiate Dependence
MeSH terms: Cocaine-Related Disorders; Opioid-Related Disorders
Study type: Interventional

Summary: 
      A total of 120 male and female opioid dependent cocaine users will participate in this study.
      This study will be a 8-week double-blind, placebo controlled study examining the
      dose-dependent effects of carvedilol (up to 50 mg/day) in methadone stabilized patients. The
      design will have two phases: 1) a four-week "treatment " phase; and 2) a 4 week " taper and
      detoxification or transfer" phase. Subjects will be cocaine users who are on stable doses of
      methadone (60 to 140 mg/day). Carvedilol dose will be increased from 12.5mg/day to the target
      dose of either 25 or 50 mg/day as tolerated. At the end of the treatment-phase, subjects will
      undergo detoxification from methadone over a 2 to 4-week period based on an individual's
      needs, and they will concurrently be tapered off carvedilol.
    

Detailed description: 
      The adrenergic neurotransmission serves multiple functions including learning, emotional
      processing and stress response to psychological and physical challenges (Huether, 1996; Sved
      et al., 2001). Adrenergic transmission also mediates drug withdrawal states and
      stress-induced relapse to drug use (Aston-Jones et al., 2004; Stewart, 2000). Consistent with
      these preclinical findings, adrenergic blockers showed promise as a treatment of cocaine
      dependence (Kampman et al., 2001b; Kampman et al., 2006). These preliminary findings are
      significant because there are no proven pharmacotherapies for cocaine addiction although an
      estimated 2.3 million of Americans aged 12 or older are regular cocaine users (SAMHSA, 2004).
      The societal cost of cocaine addiction is estimated to be $45 billion in the US, suggesting
      that development of even modestly effective cocaine pharmacotherapies will have great
      economic benefits. For example, availability of a medication decreasing cocaine use by 10
      percent is estimated to have $745 million economic benefit in the US alone (Cartwright,
      2000). Thus, developing effective treatments for cocaine addiction is an essential goal with
      significant benefits both for the society and the individual.
    

Intervention name(s): sugar pill; Carvedilol 25 mg; Carvedilol 50 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects randomized to placebo, carvedilol 25mg or 50mg; subjects randomized to placebo, carvedilol 25mg or 50mg; subjects randomized to placebo, carvedilol 25mg or 50mg
Other intervention name(s): placebo; Coreg; Coreg
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: cocaine, opiate, methadone, carvedilol
Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients
Condition: SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of STI-1558 in healthy subjects and the
      safety, pharmacokinetics, and efficacy in SARS-CoV-2-Positive subjects.
    

Detailed description: 
      This is a two-part, randomized, double-blind, placebo-controlled study evaluating the safety
      and pharmacokinetics (PK) of a single ascending dose of STI-1558 in healthy subjects and the
      safety, PK and efficacy of a multiple ascending dose in SARS-CoV-2-positive subjects.
    

Intervention name(s): STI-1558
Intervention type(s): Drug
Intervention description(s): An oral small molecule prodrug that effectively inhibits the SARS-CoV-2 main protease (Mpro).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Transcranial Direct Current Stimulation on Visual Attention - Single Sessions
Condition: Healthy Aging; Cognitive Change; Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Recently, attention has been drawn to non-invasive brain stimulation techniques, such as
      transcranial direct current stimulation (tDCS), in order to enhance cognitive functions by
      modifying brain plasticity and use it in different healthy and diseased populations. In the
      current research, investigator aim to examine the short-term effects of multiple tDCS
      protocols in healthy adults population on visual attention and identify the neural
      underpinnings of tDCS-induced behavioral aftereffects using a combined tDCS/ MRI
      network-based approach.
    

Detailed description: 
      Investigator will investigate the shor-term effects of active tDCS as compared to a placebo
      stimulation on visual attention in the healthy seniors. A cross-over, randomized,
      placebo-controlled design will be used. Single tDCS sessions will be performed in 4 sessions
      over distinct brain areas with ongoing visual attention training. During the stimulation,
      investigator will use the visual matching task. MRI protocol consisting of T1 and resting
      state fMRI sequences will be acquired before and after every stimulation session in order to
      search for active vs. placebo tDCS-induced changes in brain activation and resting state
      functional connectivity and to identify neural correlates of behavioral changes.
    

Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): 2mA stimulation for 20 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Transcranial direct current stimulation; Healthy seniors; Healthy adults
A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics
Condition: Diabetes Mellitus Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a prospective, randomized, double-blind, placebo controlled study. Patients with
      established Type 1 diabetes will be eligible for entry into the study. Eligible patients will
      be screened and those who fulfill all inclusion/exclusion criteria will be admitted to the
      inpatient unit no fewer than 2 days and no more than 7 days after Screening. Patients will
      report to the inpatient unit at 6 a.m. and outfitted with a continuous glucose monitoring
      (CGM) device. Patients will be given standardized meals and snacks for the duration of their
      inpatient visit.
    

Detailed description: 
      For the first 3 days, patients will be dosed with placebo 45 minutes prior to each of the
      day's 3 meals to establish baseline insulin requirements. Patients will be dosed with
      exogenous insulin according to their normal sliding scale and each patient's daily insulin
      requirement will be documented. The average daily insulin requirements during the 3 day
      run-in period will constitute the patient's baseline insulin level.

      Following the 3 day run-in, the CGM device will be detached, its data download, and the
      patient refitted with the CGM with a fresh cannula for continued monitoring during the 7-day
      treatment period.

      Patients will be randomized 2:1 to receive ORMD-0801 or placebo for the 7-day double-blind
      treatment period.
    

Intervention name(s): ORMD-0801 Capsules; Placebo
Intervention type(s): Biological; Other
Intervention description(s): API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules.; Fish oil capsules, identical in appearance to the experimental intervention.
Other intervention name(s): Oral Insulin; Fish Oil
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes type 1; Oral Insulin; Safety; Tolerability; Phase 2a; Randomized; Blinded; Parallel
Fish Oil Supplementation to Pregnant Women in China
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This randomized controlled trial with fish oil supplementation to pregnant women conducted in
      areas of China, which are generally low in fish intake and low income, aims at answering the
      following primary questions:

        -  Is a dose of 2.0 g/d long chain n-3 fatty acids efficient in preventing preterm birth

        -  Is a dose of 0.5 g/d long chain n-3 fatty acids efficient in preventing preterm birth

        -  Is a dose of 0.5 g/d as efficient as a dose of 2.0 g/d in affecting timing of
           spontaneous delivery in the preterm period
    

Detailed description: 
      The basic design is that of a randomized controlled trial with three groups randomized in
      ratios of 1:1:1. Two different doses of long chain n-3 fatty acids are tested against zero
      grams long chain n-3 fatty acids (lc-n3FA). These are provided in similarly looking gelatine
      capsules with either fish oil, a mixture (1:3) of fish oil and olive oil, or olive oil.
      Eligible women are randomized at around gestation weeks 16-24 and are asked to take the
      capsules until they have completed the preterm period (i.e. at 37 full gestation weeks) or
      until they deliver. Women are asked to complete questionnaires at randomization about diet
      and other baseline information, and again in gestation week 30 and after delivery. The trial
      is undertaken at hospitals in the two provinces of Gan-Su and Shaanxi. The three
      randomization groups will be compared with respect to proportions of preterm delivery. Cox
      regression will be used to compare the groups with respect to rates of spontaneous deliveries
      while accounting for elective delivery by regarding these as censoring events.
    

Intervention name(s): High dose fish oil; Low dose fish oil; Olive oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Four 0.72-gram gelatine capsules per day with fish oil providing 2.0 g/d lc-n3FA; Four 0.72-gram gelatine capsules per day with a mixture of fish oil and olive oil providing 0.5 g/d lc-n3FA; Four 0.72-gram gelatine capsules per day with olive oil providing 0 g/d lc-n3FA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: fish oil, preterm birth, pregnancy, China, prevention
Single-Level TLIF: Post-Fusion Rehabilitation
Condition: Degenerative Spinal Cord Disease
MeSH terms: Spinal Cord Diseases
Study type: Interventional

Summary: 
      This investigation will assess how the timing and type of rehabilitation after a
      transforaminal lumbar interbody fusion will affect the efficacy of the surgical procedure.
      The efficacy of the procedure will be evaluated through patients' quality of life, measured
      by health-related quality of life questionnaires up to 24 months following the procedure.
      These measures will be compared to the patients' baseline value.
    

Detailed description: 
      Patients will undergo transforaminal lumbar interbody fusion for degenerative pathology at
      the L4-5 vertebral level. They will be randomized to one of three postoperative
      rehabilitation groups. Group 1 will receive "structured early rehabilitation" beginning at 7
      weeks. Group 2 will receive "Delayed rehabilitation" beginning at 13 weeks postoperatively.
      Group 3 will undergo "Self Rehabilitation" beginning at 7 weeks postoperatively. Groups 1 and
      2 will undergo rehabilitation under the supervision of a certified physical therapist for 10
      total weeks. Group 3 will undergo non-supervised rehabilitation for 10 total weeks, and will
      be given educational materials regarding which exercises to perform and at which intervals.
    

Intervention name(s): Therapist-Guided Rehabilitation; Self-Guided Rehabilitation
Intervention type(s): Other; Other
Intervention description(s): Rehabilitation consists of exercises guided by a certified physical therapist. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.; Rehabilitation consists of self-guided exercises with provided instructions. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Evaluation of Single Doses of GSK962040 in Critically Ill Patients With Enteral Feed Intolerance
Condition: Gastroparesis
MeSH terms: Gastroparesis; Critical Illness
Study type: Interventional
Phase: Phase 2

Summary: 
      The aims of MOT112571 are to assess the pharmacodynamic effects, safety, tolerability,
      pharmacokinetics, and potential therapeutic benefit of single doses of GSK962040 in
      critically ill patients with delayed gastric emptying and who are intolerant to enteral
      feeding.
    


Intervention name(s): GSK962040 (50 mg); Placebo; GSK962040 (75 mg)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cohort 1 = 50 mg; matching placebo; Cohort 2 = 75 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GSK962040; 13C octanoic acid breath test; pharmacokinetics; critically ill patients; gut motility; pharmacodynamics; tolerability; single dose; gastric emtpying
Modified Second Layer Repair for Distal Penile Hypospadias
Condition: Hypospadias
MeSH terms: Hypospadias
Study type: Interventional
Phase: Phase 2

Summary: 
      to evaluate a modification to snodgrass technique in second layer closure of distal penile
      hypospadias
    

Detailed description: 
      In our study, we applied a new modification by using an intervening layer of a
      de-epithelialized ventral derma-dartos flap for neourethral covering. we present our newly
      applied technique and its impact on the success rate.
    

Intervention name(s): Derma -Dartos Flap for second layer closure
Intervention type(s): Procedure
Intervention description(s): usage of Derma -Dartos Flap for second layer closure of a distal penile hypospadias in circumcised patients
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Techniques for Scaling and Root Planing and One Stage Full Mouth Disinfection
Condition: Periodontal Disease; Chronic Periodontitis
MeSH terms: Periodontitis; Periodontal Diseases; Chronic Periodontitis
Study type: Interventional

Summary: 
      Evaluate and compare the effectiveness in a clinical and microbial perspective one stage
      full-mouth disinfection technique in relation to scaling and root planing per quadrant
      associated with chlorhexidine or azithromycin.
    

Detailed description: 
      Seventy -seven systemically healthy subjects with chronic periodontitis were randomly
      included in 6 different predefined groups. The following periodontal parameters were
      evaluated: probing depth , clinical attachment level , plaque index, gingival index and
      percentage of areas affected by periodontal disease. Microbiologically were evaluated the
      bacterial load and specific load of five bacterias: The quantification of the bacteria was
      performed by real-time Polymerase Chain Reaction . The clinical and microbial baseline
      evaluations were performed ( periodontal pre- therapy) , 90 and 180 days after treatment.
    

Intervention name(s): Scaling and root planing; Full mouth disinfection; Chlorhexidine gel and gluconate; Chlorhexidine gluconate solution; Azithromycin
Intervention type(s): Procedure; Procedure; Drug; Drug; Drug
Intervention description(s): Scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;; Procedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days; application of chlorhexidine (CX) (1%) gel in pockets after scaling, brushing tongue for 1 min. with CX (1%) gel and mouthwash at the beginning and end of each session with CX 0.2% for 30 seconds (with the form of a gargle in the last 10 seconds); Home use fo CX 0.2% for 60 consecutive days after the end of the first session of scaling.; Azithromycin (500 mg) once daily for 3 consecutive days.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: periodontal disease; therapy; anti-bacterial agents; Randomized Controlled Trials
A Study Comparing Amounts of Tafamidis In The Blood Without Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      3 different formulations and doses of tafamidis will be compared. Subjects will be fasted for
      each test and every subject will test all 3 different formulations. After swallowing
      tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14
      days, subjects will take a different formulation of tafamidis and tafamidis blood
      concentrations will be measured periodically for 6 days. After another 14 days, the last
      formulation will be tested in the same way.
    


Intervention name(s): tafamidis
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Esophageal Deviation in Atrial Fibrillation Ablation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Catheter ablation with pulmonary vein (PV) isolation is a commonly performed strategy
      employed for the treatment of atrial fibrillation (AF). However, ablation in the posterior
      wall of the left atrium can cause thermal injury to the esophagus. Thermal injury is very
      common and occurs in up to 40% of AF ablations per some studies. When significant thermal
      injury to the esophagus occurs, two significant complications can arise: 1) the formation of
      an atrio-esophageal fistula, and 2) gastrointestinal dysmotility. While the occurrence of
      fistula is rare, it is a very important complication since it is often fatal. Currently
      luminal esophageal temperature monitoring is the most commonly employed modality to prevent
      such injury. However, there are limitations to its use, and atrio-esophageal fistulas
      continue to be a major problem in AF ablation even when using esophageal temperature
      monitoring. Esophageal deviation using either a Transesophageal echocardiogram (TEE) or
      Esophagogastroduodenoscopy (EGD) probe has been described in the literature, but the
      effectiveness and practicality of these techniques are suboptimal, and have therefore
      precluded their use in routine clinical practice. Recently, esophageal deviation using
      off-the-shelf equipment (a soft thoracic tube and endotracheal stylet) was tested in the
      randomized double-blind multicenter study "Deviating the Esophagus in Atrial Fibrillation
      Ablation (DEVIATE-AF)". In that study the standard practice (i.e., use of luminal esophageal
      temperature monitoring) was compared to esophageal deviation using off-the-shelf equipment.
      The results were very encouraging showing that esophageal deviation allowed for significant
      reductions in esophageal temperature and proportion of premature ablation terminations.
      Importantly, esophageal deviation allowed the isolation all PVs in the treatment group, which
      was not the case in the control group. One major limitation in the DEVIATE-AF trial was that
      off-the-shelf equipment tool was challenging to use. The aim of the Esophageal Deviation in
      Atrial Fibrillation Ablation study is to test the feasibility and safety of moving the
      esophagus using a specialized esophageal deviation tool (DV8, Manual Surgical Sciences,
      Minneapolis, MN).
    


Intervention name(s): DV8
Intervention type(s): Device
Intervention description(s): DV8 esophageal deviation tool
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-remitting MS
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the difference in preventing a relapse between
      Betaseron and Avonex. Patients with RRMS currently treated with Avonex will be randomized
      into 2 equal-size arms; one arm will continue on the standard dose of Avonex; one arm will be
      converted to Betaseron standard dose.
    

Detailed description: 
      This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer
      HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the
      trial.
    

Intervention name(s): Betaferon/Betaseron; Betaferon/Betaseron
Intervention type(s): Drug; Drug
Intervention description(s): Betaseron 250 µg SC every other day; Avonex 30 µg IM once per week
Intervention MeSH terms: Interferon beta-1b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement
Condition: Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and
      efficacy of daily subcutaneous administration of 5 μg/kg tbo-filgrastim in infants, children
      and adolescents with solid tumors without bone marrow involvement.
    


Intervention name(s): tbo-filgrastim
Intervention type(s): Drug
Intervention description(s): 5 μg/kg
Intervention MeSH terms: Lenograstim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neutropenia