bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Performance of the CleanC System-Israel
Condition: Colorectal Cancer (CRC) Screening
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a
      poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.
    

Detailed description: 
      The study aim to evaluate the post Procedure Cleansing Level as Measured by the Boston Bowel
      Preparation Scale (BBPS).

      Each subject was required to follow a bowel preparation regimen including split dose of 2
      tablets of 5mg Bysacodyle followed by a colonoscopy procedure with the tested device.
    

Intervention name(s): CleanC system
Intervention type(s): Device
Intervention description(s): Cleansing liquid and fecal matter during a standard colonoscopy procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Weight-reduction Intervention in Asthmatic Children With Overweight/Obesity
Condition: Asthma; Overweight; Obesity
MeSH terms: Asthma; Obesity; Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to determine the efficacy of a multifactorial intervention with
      weight reduction, behavioural therapy, and physical exercise on the severity and control of
      asthma in obese children.
    


Intervention name(s): Multifaceted intervention
Intervention type(s): Behavioral
Intervention description(s): multifaceted family-based, physical exercise, nutrition, and behavioural intervention study for 18 month, in children aged 6-16 years with asthma and overweight/obesity.
Other intervention name(s): MIKADO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: asthma; overweight; obesity; children
Inspiratory Resistive Loading and Diaphragm Fatigue
Condition: Diaphragm Fatigue; Healthy; Low Back Pain
MeSH terms: Back Pain; Low Back Pain; Fatigue
Study type: Observational

Summary: 
      The aim of the study is to clarify whether specific loading of the inspiratory muscles
      induces contractile fatigue of the diaphragm muscle in healthy individuals and individuals
      with recurrent low back pain.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        young flemish volunteers
Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 2

Summary: 
      Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale
      (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and
      placebo.
    


Intervention name(s): botulinum toxin type A; botulinum toxin type A Formulation 2; Normal Saline
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.; Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.; Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.
Other intervention name(s): BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Use of Ixmyelocel-T (Formerly Catheter-based Cardiac Repair Cell [CRC]) Treatment in Patients With Heart Failure Due to Dilated Cardiomyopathy
Condition: Dilated Cardiomyopathy
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to assess the safety profile and the efficacy of cardiac repair cells
      (CRCs) administered via catheter in treating patients with dilated cardiomyopathy (DCM).
    

Detailed description: 
      Heart failure remains a major public health problem, affecting 5 million patients in the US,
      with 550,000 new diagnoses made each year (Hunt SA; et al., 2005). Heart failure is the
      leading cause of hospitalization in persons over 65 years of age with cost exceeding $29
      billion annually. Prognosis is very poor once a patient has been hospitalized with heart
      failure. The mortality risk after heart failure hospitalization is 11.3% at 30 days, 33.1% at
      1 year and well over 50% within 5 years (Hunt SA; et al., 2005). These numbers emphasize the
      need to develop and implement more effective treatments to manage heart failure.

      Aastrom is targeting a subset of heart failure patient population, namely those diagnosed
      with dilated cardiomyopathy. The World Health Organization (WHO) defines dilated
      cardiomyopathy (DCM) as a cardiac condition wherein a ventricular chamber exhibits increased
      diastolic and systolic volume and a low (<40%) ejection fraction (Manolio TA; et al., 1992;
      Towbin JA; et al., 2006). DCM is reported to affect 108,000 to 150,000 patients in the United
      States (Richardson P; et al., 1996; Towbin JA; et al., 2006).

      This study is a prospective, stratified, randomized, open-label, controlled, multi-center
      study to assess the safety profile and the efficacy of CRCs administered via catheter in
      treating patients with DCM. Two strata will be used: ischemic (IDCM) and non-ischemic
      (NIDCM). Within each stratum, patients will be randomized to receive either CRC treatment or
      control in a 2:1 ratio (8 patients per CRC treatment group and 4 patients per control group).
      It will enroll a total of 24 patients at 2 sites in the U.S.
    

Intervention name(s): Ixmyelocel-T; Vehicle Control
Intervention type(s): Biological; Other
Intervention description(s): CRCs will be administered via catheter-based injection to the endocardial surface of the left ventricle.; will receive approximately 12-20 intramyocardial injections of 0.4 mL each of vehicle control into the left ventricle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ischemic Dilated Cardiomyopathy; Non-Ischemic Dilated Cardiomyopathy; ixmyelocel-T
Monitoring Patients Who Are Obese Surgery for Gastric By-pass Protein Supplementation and Physical Training (PROMISE)
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to test whether additional protein intake with or without
      strength training will help to maintain body composition (fat-free mass) after surgical
      treatment of obesity by gastric by pass. The main hypothesis is that additional protein
      intake will limit fat-free mass loss during surgery-induced weight loss, and that strength
      training will have an additional beneficial effect
    

Detailed description: 
      Design: Open randomised controlled trial comparing, in obese patients after GBP, an
      additional oral intake of protein with or without a muscular-strengthening physical training
      programme (18 weeks) to standard medical and nutritional follow-up after bariatric surgery as
      control (3 groups). Primary outcome: Variation at 6 months after GBP in total and
      appendicular fat-free mass as assessed by dual-energy X-ray absorptiometry (DXA). Duration of
      the study: 36 months. Duration of participation for one patient: 7 months. Number of centers:
      Monocentric study.
    

Intervention name(s): Protein supplementation and strength training; Protein supplementation
Intervention type(s): Behavioral; Dietary Supplement
Intervention description(s): Protein supplementation and strength training; Protein supplementation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Gastric by-pass; Body composition; Nutrition; Physical activity
A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate
      (tenofovir DF).
    


Intervention name(s): Tenofovir DF; Tenofovir alafenamide
Intervention type(s): Drug; Drug
Intervention description(s): Tenofovir DF tablet administered orally once daily; Tenofovir alafenamide tablet(s) administered orally once daily
Other intervention name(s): Viread®; GS-7340
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: treatment naive
Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, randomized, multi-center, 2-way crossover Pharmacokinetic
      PK evaluation of a single inhaled dose of CVT-301 84 mg and a single oral dose of
      carbidopa/levodopa CD/LD 25 mg/100 mg (Sinemet®) under fed conditions in Parkinson's Disease
      (PD) patients who regularly take CD/LD.
    

Detailed description: 
      The study duration includes a screening period followed by an overnight stay in the center (4
      days, 3 nights) to complete 2 treatments, including a 48-hour interval between the
      treatments, and a follow-up phone call 1-2 days after discharge from the center.

      On each of two treatment days, subjects will consume a standard high fat meal and then
      receive either (A) a single inhaled dose of CVT-301 or (B) a single dose of oral CD/LD
      followed by Pharmacokinetic (PK) sampling for 4 hours. A crossover design will be used such
      that each subject receives both Treatment A and Treatment B over the 2 treatment days,
      randomized 1:1 to the treatment sequence AB or BA.
    

Intervention name(s): CVT-301; Sinemet
Intervention type(s): Drug; Drug
Intervention description(s): Levodopa Inhalation Powder; Single oral dose of Carbidopa/Levodopa 25 mg/100 mg
Intervention MeSH terms: Carbidopa, levodopa drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: It is a 2-way crossover Pharmacokinetic (PK) evaluation of a single inhaled dose of CVT-301 84 mg and a single oral dose of Carbidopa/levodopa (CD/LD) 25 mg/100 mg (Sinemet®) under fed conditions in Parkinson's Disease patients who regularly take CD/LD.
Masking: None (Open Label)
Primary purpose: Other
Efficacy and Safety Evaluation of Octreotide in the Treatment of Congenital Hyperinsulinemia
Condition: Congenital Hyperinsulinaemic Hypoglycaemia; Octreotide Adverse Reaction
MeSH terms: Congenital Hyperinsulinism; Nesidioblastosis; Hypoglycemia
Study type: Observational

Summary: 
      To analyze and evaluate the efficacy and safety of octreotide subcutaneous injection in the
      treatment of diazazine-ineffective congenital hyperinsulinemia (CHI) in children.
    

Detailed description: 
      Octreotide subcutaneous injection is effective and safe in the treatment of congenital
      hyperinsulinemia in children with inefficacy of diazazine.
    

Intervention name(s): Octreotide Injection
Intervention type(s): Drug
Intervention description(s): Octreotide subcutaneous injection for congenital hyperinsulinemia with ineffective diazine
Other intervention name(s): glucose
Intervention MeSH terms: Octreotide
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children with congenital hyperinsulinemia who received octreotide subcutaneous injection
        after diazazine treatment failed.
Stress and Marijuana Cue-elicited Craving and Reactivity
Condition: Cannabis Use Disorders
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      The purpose of this study is to explore the interaction between stress and marijuana cues, in
      hopes that it may lead to the development of new treatments for marijuana dependence.
    

Detailed description: 
      Although use of marijuana is widespread, little research has focused on the treatment of
      marijuana use disorders or on predictors of relapse. Although several factors contributing to
      relapse have been explored in other dependencies (i.e., alcohol, cocaine), little research
      has focused on drug cue-related or stress-induced relapse in marijuana-dependent individuals.
      Cue reactivity is a construct measured in a laboratory procedure where an individual's
      subjective, behavioral, and physiological responses are assessed following exposure to
      drug-related environmental cues or stressors. Investigating the effects of drug-related
      environmental cues and stress in marijuana-dependent individuals will be useful in guiding
      treatment development.
    

Intervention name(s): Stress + cue exposure; No stress + cue exposure
Intervention type(s): Other; Other
Intervention description(s): Trier Social Stress Task(TSST): subject is asked to give a talk and perform a math task in front of an audience, follwed by neutral and marijuana cue exposure.; Neutral and marijuana-associated cue exposure (scripted imagery, in vivo cues).
Other intervention name(s): Stress stask, TSST; marijuana cue exposure, neutral cue exposure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: substance-related disorders
Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes.
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by
      itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.
    

Detailed description: 
      SYR-322 (alogliptin) is a selective, orally available inhibitor of dipeptidyl peptidase IV
      being developed as a treatment for type 2 diabetes mellitus. Dipeptidyl peptidase IV is the
      primary enzyme involved in the in vivo degradation of at least 2 peptide hormones released in
      response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent
      insulinotropic peptide.

      Pioglitazone HCl (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries,
      Ltd. (Osaka, Japan). Pioglitazone HCl depends on the presence of insulin for its mechanism of
      action.

      This study will assess the effects of alogliptin and alogliptin coadministered with
      pioglitazone HCl on postprandial lipid and lipoprotein metabolism in participants with type 2
      diabetes. Individuals who participate in this study will be required to commit to a screening
      visit and up to 6 additional visits at the study center. Study participation is anticipated
      to be about 20 weeks (or approximately 5 months). Multiple procedures will occur at each
      visit which may include fasting, blood collection, urine collection, physical examinations
      and electrocardiograms. At 3 of the visits a meal will be served that must be eaten within 10
      minutes.
    

Intervention name(s): Alogliptin and Pioglitazone; Alogliptin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.; Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.; Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Other intervention name(s): alogliptin; SYR110322; Actos; AD-4833; SYR-322; SYR110322; SYR-322; Actos; AD-4833; SYR-322
Intervention MeSH terms: Pioglitazone; Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus; Lipoatrophic; Dyslipidemia; Drug Therapy
Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Laparoscopic Colorectomy
Condition: Post-Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug
      candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel,
      placebo-controlled study.
    

Detailed description: 
      VVZ-149 is a dual antagonist of GlyT2 and 5HT2A. GlyT2 blockage increases inhibitory synaptic
      transmission by glycine in the spinal cord, resulting in a reduction of pain transmissions to
      the brain. 5HT2A blockage decreases descending serotonergic facilitatory modulation on pain
      transmission by the brain and reduces nociceptor activation in peripheral nerves, which are
      primary sources of pain in post-surgical pain. VVZ-149 has been shown to have comparable
      efficacy to morphine in well controlled (blind, complete randomization with a positive
      control) animal studies using rat models of post-operative pain and formalin-induced pain.
      The PK/PD study in animals indicates that therapeutic plasma concentration in human subjects
      will be 600-1,900 ng/ml. A clinical Phase 1 study performed in healthy subjects has shown no
      clinically significant adverse events up to a plasma concentration level of 3,261 ng/ml other
      than brief symptoms of mild nausea or dizziness, and mild somnolence when the plasma exposure
      level is more than 2,000 ng/ml. A clinical Phase 2 study performed in laparoscopic
      gastrectomy patients showed that patients who received VVZ-149 had reduced opioid consumption
      after surgery compared to those who received placebo, without any significant drug-related
      adverse events.
    

Intervention name(s): VVZ-149 Injections; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion of 900 or 1100 mg of VVZ-149; IV infusion of 0 mg of VVZ-149
Other intervention name(s): Opiranserin Injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Lanreotide in the Treatment of Small Bowel Motility Disorders
Condition: Gastrointestinal Motility Disorder; Intestinal Disease
MeSH terms: Intestinal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a human research study looking at the effectiveness of Lanreotide (study medication)
      in treating small bowel motility disorders. It is similar to a natural hormone somatostatin
      that is produced in the body in the stomach, duodenum, pancreas and brain. Somatostatin is a
      growth hormone-inhibiting hormone. Lanreotide is a man made hormone and is a long acting
      medication that is given once a month. It is marketed with a trade name "Somatuline Depot".
      It is given deep subcutaneously (deep within the layers of the skin) in the superior external
      quadrant of the buttock. Injection site will be alternated on subsequent injections.
    

Detailed description: 
      The investigators hypothesize that in patients with small bowel motility disorders,
      Lanreotide helps in alleviating the symptoms. Lanreotide is an FDA approved medication for
      management of acromegaly and neuroendocrine tumors, but has never been used for treating
      small bowel motility disorders. However, Octreotide which is similar to Lanreotide but is a
      short acting synthetic somatostatin has been used in few research studies.

      If a patient is interested and qualifies for the study then he/she will be explained about
      the study and signature will be collected on the consent form. Health and social history will
      be collected. Blood work, urine analysis, pregnancy test (in women of reproductive age group
      and have the capability of getting pregnant)) will be performed to make sure that patient
      qualifies for the study and for follow-up during the treatment. Physical examination, ECG,
      wireless motility capsule testing and hydrogen breath testing will be performed. Patients
      will be required to complete a questionnaire regarding their health.

      The total study duration from the first administration of study drug is 12 weeks. The study
      medication will be given once a month for 3 months and there is a 1 month follow-up after the
      last study medication. There will be a screening visit approximately 1 month before the first
      study drug administration.
    

Intervention name(s): Lanreotide
Intervention type(s): Drug
Intervention description(s): Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart
Other intervention name(s): Somatuline
Intervention MeSH terms: Lanreotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Small bowel motility disorder; Slow intestinal motility; Small bowel bacterial overgrowth
A Comparison of McGrath MAC®, Pentax-AWS® and Macintosh Direct Laryngoscopes for Nasotracheal Intubation
Condition: Intubation;Difficult
Study type: Interventional

Summary: 
      A comparison of intubation time, difficulty of intubation in nasotracheal intubation using
      McGrath MAC®, Pentax-AWS® and Macintosh direct laryngoscopes
    

Detailed description: 
      This trial is prospective randomized trial. The Objects are adult patients who need
      nasotracheal intubation for surgery. Using computed randomized table, participants are
      assigned to three groups, McGrath MAC®, Pentax-AWS® and Macintosh direct laryngoscopes.

      The intubation will be done by One expert anesthesiologist who have more than 10 years
      experience.

      Investigators compare intubation time, success rate and difficulty between three groups.
    

Intervention name(s): McGrath; Pentax; Macintosh
Intervention type(s): Device; Device; Device
Intervention description(s): McGrath videolaryngoscope; Pentax videolaryngoscope; Macintosh direct laryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Pharmacokinetic (PK) Study of Oral Bendavia Administered for 7 Days
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the study medication blood levels after administration
      of a repeat oral capsules (one capsule each day for seven days) of Bendavia at one of two
      dose levels. The effects of Bendavia on the volunteers will also be assessed.
    


Intervention name(s): Bendavia 10mg; Bendavia 50mg; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): MTP-131; MTP-131
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science