bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Colon Carcinoma Dukes C
Condition: Colon Cancer Stage III
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical investigation examined the effectivity 5-fluorouracil, of adding levamisol or
      interferon to 5-fluorouracil, and of a 5-fluorouracil/levamisol/interferon triple
      combination, in terms of recurrence-free and overall survival in curatively operable colon
      carcinoma Stage III.
    


Intervention name(s): 5-fluorouracil, levamisol, interferon
Intervention type(s): Drug
Intervention MeSH terms: Interferons; Fluorouracil
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fluorouracil; Levamisol; Interferon; Colon cancer
A Safety and Tolerability Study of Dapivirine (TMC120) Vaginal Microbicide Gel
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Approximately 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter
      study at four sites. Volunteers will be randomized to dapivirine (TMC120) vaginal gel or
      matching placebo gel. The volunteers will receive investigational product for a total of 42
      days. Volunteers will be monitored on days 7, 28 and 42 for safety, tolerability and
      compliance.
    


Intervention name(s): dapivirine (TMC120) vaginal gel
Intervention type(s): Drug
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: HIV-1; HIV Seronegativity
Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects
      who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate
      the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS)
      outcomes in subjects who completed Study 109MS202 (NCT02410200).
    


Intervention name(s): dimethyl fumarate
Intervention type(s): Drug
Intervention description(s): administered orally
Other intervention name(s): DMF; BG00012
Intervention MeSH terms: Dimethyl Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatrics
Significance of Fluorescence Colposcopy With Autofluorescence Imaging for Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      Clinical Trial to access Significance of fluorescence colposcopy with autofluorescence
      imaging for the screening of cervical cancer
    

Detailed description: 
      1. Perform pelvic vaginal exam of the subjective to know symptom, illness history, physical
           exam and basal state before fluorescence colposcopy.

        2. Observe acetowhite epithelium and perform biopsy at suspicious lesion during
           fluorescence colposcopy.

        3. Perform fluorescence colposcopy again after biopsy and confirm extraordinary reaction.

        4. After 1~2weeks follow up the subjective at opd and confirm biopsy result.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        tertiary center
      
Keywords: fluorescence colposcopy; cervical cancer
A Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies
Condition: Scabies
MeSH terms: Scabies
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase III study was conducted to establish the clinical bioequivalence of Permethrin
      Cream 5% and Elimite™ in the treatment of scabies following a single application.
    

Detailed description: 
      A Double Blind, Two Arm, Multicenter, Randomized, Parallel Group Bioequivalence Study with
      Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of, Permethrin Cream 5%
      (Manufactured by Saptalis Pharmaceuticals, LLC) & Elimite™ (Permethrin Cream 5%, manufactured
      for Prestium Pharma, Inc.) in Subjects with Scabies.

      The objectives of this study are:

      Primary Objective: To establish the clinical bioequivalence of Permethrin Cream 5%
      (manufactured by Saptalis Pharmaceuticals, LLC) and Elimite™ (Permethrin Cream 5%,
      manufactured for Prestium Pharma, Inc.) in the treatment of scabies (Sarcoptes scabiei)
      following a single application.

      Secondary Objective: To compare the safety and tolerability between the study drugs.
    

Intervention name(s): Permethrin Cream 5%
Intervention type(s): Drug
Intervention description(s): Patients will be assigned to the test product Permethrin Cream 5% to the Reference Listed Drug Product Elimite cream.
Intervention MeSH terms: Permethrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy, Pharmacokinetics and Safety of Testosterone
Condition: Testicular Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label study of a single and repeated application of three dose levels of
      topical testosterone in hypogonadal males with morning serum testosterone concentrations <
      297 ng/dL.
    


Intervention name(s): Testosterone gel (FE 99903)
Intervention type(s): Drug
Intervention MeSH terms: Testosterone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men
Condition: Hypogonadism; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Hypogonadism
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a blinded and placebo-controlled study of topical testosterone replacement therapy
      (TRT) in symptomatic hypogonadal men with increased risk for cardiovascular (CV) disease.
    


Intervention name(s): Testosterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): It will be administered topically.; A matching placebo to testosterone will be administered topically.
Other intervention name(s): Androgel®
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypogonadism; cardiovascular (CV) disease; AndroGel; testosterone replacement therapy (TRT)
Long-term Effectiveness Study on Cholesterol-reducing Activity
Condition: Normal and Mild Hypercholesterolemic Subjects
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of consumption of a drinkable low fat
      fermented milk enriched with 0,8g or 1,6g of plant sterols on reducing plasma cholesterol
      (LDL-cholesterol) concentration during 12 weeks of product consumption.
    


Intervention name(s): 1 - low-fat dairy fermented product (drinkable) enriched with plant sterols (0,8g /day equivalent as free sterols).; 2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols).; 3 - low-fat dairy fermented product (drinkable) without plant sterols.
Intervention type(s): Other; Other; Other
Intervention description(s): 1 = Intervention with test product 1 (0,8g of plant sterol/day); 2 = Intervention with test product 2 (1,6g of plant sterol/day); 3 = Intervention 3 (1 control product/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Plant sterol - Hypercholesterolemia - Diet - Dairy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants
Condition: Healthy Participant
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD)
      study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)
      of DNL919.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): DNL919; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single doses; Single doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Prospective Study to Evaluate the Specificity of the Cobas TaqScreen MPX Test for Use on the Cobas s 201 System for Screening Plasma Pools From Source Plasma Donors for the Presence of HBV DNA, HCV RNA, and HIV-1 RNA
Condition: Healthy Volunteer
Study type: Interventional

Summary: 
      This study will evaluate the specificity of the cobas TaqScreen MPX Test for the simultaneous
      detection of HBV DNA, HCV RNA and HIV-1 Group M in a minimum of 100,000 individual donor
      samples in 96-unit pools.
    


Intervention name(s): cobas s 201 TaqScreen MPX Test
Intervention type(s): Device
Intervention description(s): Donors testing reactive for one or more of the viral markers will be advised to seek further advice/treatment from their physician.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels
Condition: Vestibular
MeSH terms: Motion Sickness; Space Motion Sickness
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators will study adaptation of motion perception and manual control in altered
      gravity, including the effects of a drug (promethazine). The investigators will also study
      whether promethazine affects motion perceptual thresholds.
    

Detailed description: 
      Adaptation to altered gravity has been of concern from the earliest reports of space motion
      sickness, through the Apollo exploration era, and into current planning of exploration
      missions. The proposed research program takes a new approach which could lead to an
      effective, practical and acceptable protocol for preadapting astronauts to space flight. By
      using the gravito-inertial alterations possible with centrifugation in different body
      orientations the investigators will quantify an individual's sensory adaptation capability
      and use it to predict and to minimize the consequences of movement in any other gravity
      environment - eventually including weightlessness. The investigators will also study whether
      a drug (promethazine) affects motion perception and motion sickness.
    

Intervention name(s): Promethazine; Hyper gravity training; Placebo; No hypergravity training
Intervention type(s): Drug; Behavioral; Drug; Behavioral
Intervention description(s): Subject receives promethazine; Subject receives hypergravity training before testing; Placebo; Subjects do not receive normal Earth gravity
Other intervention name(s): Phenergan; corn starch
Intervention MeSH terms: Promethazine; Diphenhydramine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The design includes three separate studies:
Arm 9&10 follows a crossover design. These results were reported in Diaz-Artiles et al 2017.
Arms 1-4 are a separate study which follow a factorial design, with arm 2 serving as the placebo, arms 1 and 3 assessing the effects of two separate interventions and arm 4 assessing the effect of two combined interventions.
Arms 5-8 are a separate study which follow a factorial design, with arm 6 serving as the placebo, arms 5 and 7 assessing the effects of two separate interventions and arm 8 assessing the effect of two combined interventions.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Efficacy vs Placebo as Initial Combination Therapy With Pioglitazone
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the current study is to investigate the efficacy, safety and tolerability of
      BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial
      combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with
      insufficient glycaemic control.
    


Intervention name(s): placebo + pioglitazone (30 mg); Linagliptin + pioglitazone (30 mg)
Intervention type(s): Drug; Drug
Intervention description(s): placebo + overcapsulated 30 mg tablet, once daily; 5 mg tablet + overcapsulated 30 mg tablet, once daily
Intervention MeSH terms: Pioglitazone; Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Bolus vs. Continuous IV Lidocaine Against Post-Extubation Cough in Post-Thyroidectomy Patients
Condition: Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this randomized controlled trial is to compare the effect of lidocaine bolus
      intravenous administration to lidocaine continuous intravenous administration in post
      thyroidectomy patients to observe the effect against post-extubation cough. The main
      questions it aims to answer are:

        -  Cough incidence on both groups

        -  Which method is preferable to reduce post-extubation cough incidence
    


Intervention name(s): Lidocaine IV
Intervention type(s): Drug
Intervention description(s): Lidocaine given as bolus or continuous infusion.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparison
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Web-based CBT for Children With Chronic Pain
Condition: Chronic Pain; Headache; Abdominal Pain
MeSH terms: Chronic Pain; Headache; Abdominal Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to develop and evaluate the feasibility and effectiveness of a
      web-based (i.e., internet) treatment approach for providing psychological treatment to reduce
      pain and improve functioning in children and adolescents with chronic pain.
    

Detailed description: 
      Chronic pain is an important problem for children and adolescents owing to its high
      prevalence rate and significant impact on children's mood, daily functioning, and overall
      quality of life. Effective psychological treatments have been developed to change behaviors
      and thoughts important in the child's ability to cope with chronic pain. However, the
      majority of children do not have access to these treatments due to a variety of barriers such
      as geographical distance from pediatric pain treatment centers.

      The purpose of this study is to develop a more accessible method of delivering effective
      psychological treatment to reduce pain and increase function in children. Children with
      chronic headache, abdominal, or musculoskeletal pain will be randomized to either receive the
      web-based treatment right away or to be in a wait-list control condition and receive the
      treatment 8 weeks later. Both groups of children will continue to receive clinical care
      through specialty medical clinics. Children's level of pain, their ability to perform, daily
      functional activities, and overall quality of life will be evaluated before treatment begins,
      immediately after treatment, and at a 3 month follow up.
    

Intervention name(s): cognitive-behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): In addition to standard medical care, the children and parents in the family CBT condition will also receive education about chronic pain, pain behaviors and operant strategies as well as training in coping skills using an interactive, engaging format on the Internet.
The Internet site will consist of three main sections: child treatment modules, parent treatment modules, and diary tracking. All users will complete 8 treatment modules (one per week) over the 8-week treatment period. Each module will require approximately 30-40 minutes to complete. There is separate specific content of the intervention for child users and for parent users.
Assignments are incorporated into each module for the participant to work on during the treatment week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognitive-behavioral therapy; chronic pain; randomized controlled trial; pediatrics
Clinical Experiment of Helicobacter Pylori Transmission
Condition: Infection; Achlorhydria
MeSH terms: Infections; Achlorhydria
Study type: Interventional

Summary: 
      The study proposes to test whether chronic infection with Helicobacter pylori protects
      individuals from symptomatic infection with enteropathogenic E. coli. The study will also
      evaluate the effect of gastric acidity in this relationship.
    

Detailed description: 
      Because H. pylori is an enteric infection, its prevalence may be linked to exposure to other
      enteric pathogens. Results of observational studies on the association between H. pylori and
      gastroenteritis, however, have been conflicting. Some have shown increased incidence of
      diarrhea in children with H. pylori infection, with one study attributing 11% of diarrhea
      cases to H. pylori. Other studies found no association, and still others found a protective
      effect of H. pylori against gastroenteritis. Dissecting out confounding from true
      physiological associations can be difficult in observational studies. To better elucidate the
      association between H. pylori and gastroenteritis, we performed a direct challenge experiment
      with a well-characterized gastrointestinal pathogen, enteropathogenic Escherichia coli
      (EPEC). EPEC is a leading cause of infantile gastroenteritis in the world and has a long
      history of safe use in human experiments. It is also acid sensitive: in our laboratory less
      than 0.001% of inoculated EPEC organisms survived at pH 2.5. Our goal was to test the
      hypothesis that chronic infection with H. pylori increases the risk of diarrheal illness
      after direct challenge with EPEC.
    

Intervention name(s): Biological intervention: Enteropathogenic E. coli
Intervention type(s): Biological
Intervention description(s): 5x10^8 or 1x10^9 organisms of EPEC were administered to all participants.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Physical Performance Measures for Manual Wheelchair Users
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The project is intended to modify the Functional Independence Measure (FIM) for manual
      wheelchair users. It will determine if the new measure is a better measure of community
      independence for manual wheelchair users than the FIM. During the Phase 1 of the study it
      will then use this new measure to determine whether a home exercise program increases
      functional independence in wheelchair users. In Phases II and III of the study 120 manual
      wheelchair users will participate to test and validate the new measure and to test the
      effectiveness of therapeutic exercise. Subjects will range in age from 20 to 79 yrs. and have
      a variety of disabilities.
    


Intervention name(s): Performance Measure
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: wheelchair, biomechanics, aging, functional outcome, disability
Anti-Snoring Appliances and Airway Manipulation in Patients Undergoing Anesthetic Sedation
Condition: Airway Obstruction; Snoring; Sedation Complication
MeSH terms: Airway Obstruction; Snoring
Study type: Interventional

Summary: 
      Would patients using an anti-snoring appliance intraoperatively require less airway
      manipulation, interventions, and rescue maneuvers during anesthetic sedation cases compared
      to those who do not? The investigators will use anti-snoring appliance devices (specifically
      the FDA approved Zyppah) to attempt to relieve tissue obstructions that cause snoring during
      sleep. The application of the devices to the body is less invasive than other common
      intraoperative rescue airway devices (e.g. nasal trumpets and oral airways) which are not
      designed to be patient specific.
    


Intervention name(s): Anti-snoring device; No anti -snoring device during their procedure.
Intervention type(s): Device; Procedure
Intervention description(s): For group 1, the study team will aid the subject in molding and preparing the device in the pre-operative area. They will wear the device throughout the entirety of the case.; For group 2 there will be no anti snoring device used during the case.
Other intervention name(s): No intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled interventional trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Airway obstruction; Snoring; Monitored Anesthesia Care; Intravenous sedation