bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study Into the Cosmetic Results of Leukosan Adhesive
Condition: Wound Healing Cosmetic Result
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      This clinical study aims to assess whether the benefits of using Leukosan Adhesive on trocar
      incisions are greater or equivalent to those provided by the standard therapy of
      transcutaneous sutures.

      In particular, it tests the long-term cosmetic result after 3 months, the safety and
      tolerance, as well as the practicality of treatment with Leuksan Adhesive.

      An open, randomised, controlled, prospective, single location, clinical study of women of
      ages between 18 and 60 years within the time span of March 2013 and April 2013.
    

Detailed description: 
      The medical devices compared were EU (European Union) approved market-ready products with
      relevant designation according to the legal requirements for medical devices and according to
      Council guideline 93/42/EWG dated 14th July.

      Leukosan Adhesive is a sterile, ultra high viscose adhesive for external skin closure. Due to
      the skin's moisture, this skin adhesive polymerizes within seconds into a flexible film
      firmly holding the edges of the wound together and protecting the wound itself.

      Premilene DSMP 24, 3/8 needle, thread 3/0 denier was used a a comparison. This suture
      material was the standard suture material used in the study centre.
    

Intervention name(s): Leukosan Adhesive; Transcutaneous suture
Intervention type(s): Device; Device
Intervention description(s): Leukosan adhesive applied to one wound; Transcutaneous suture applied to one wound
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: wound healing; cosmetic results; trocar incision
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an 8-week, multicenter, open-label study in which eligible subjects with a history of
      otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is
      designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement
      with common concurrent surgeries and any middle ear effusion status.
    


Intervention name(s): OTO-201 (ciprofloxacin)
Intervention type(s): Drug
Other intervention name(s): OTIPRIO
Intervention MeSH terms: Ciprofloxacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Otitis media; Ear infection; Tympanostomy tubes
Eltrombopag for Treatment of Fanconi Anemia
Condition: Fanconi Anemia
MeSH terms: Fanconi Syndrome; Anemia; Fanconi Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      An open-label, phase II study to assess the efficacy and safety of eltrombopag for the
      treatment of children and adolescents with Fanconi anemia.
    

Detailed description: 
      Open-label, phase II study to assess the efficacy and safety of eltrombopag in the treatment
      of patients diagnosed with Fanconi anemia who have no immediate curative treatment for their
      bone marrow failure (n=10). The primary objective of this open-label, phase II proof of
      concept study is to assess the efficacy and safety of using eltrombopag for the treatment of
      patients with FA before conducting a larger phase II/III study.

      Specific objectives:

        -  Primary: To assess the efficacy of eltrombopag on hematopoiesis by measuring changes in
           peripheral platelet, hemoglobin and neutrophil counts.

        -  Secondary: To assess the safety of eltrombopag in patients with Fanconi anemia. If the
           preliminary efficacy and safety results from the study are positive, we will propose its
           expansion to a multi-institutional Phase II/III study within the framework of the
           Spanish Fanconi Anemia Research Network.
    

Intervention name(s): Eltrombopag
Intervention type(s): Drug
Intervention description(s): Eltrombopag tablets by mouth once daily for 24 weeks (6 months) with the dose depending on race, age and weight.
Other intervention name(s): Revolade®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fanconi Anemia
Transcranial Random Noise Stimulation (tRNS) Over Fronto-temporal Cortex Improves Verbal Fluency and Empathy in Autism Children
Condition: Autism; ASD
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      Interventional, prospective, randomized, double-blind, placebo-controlled and parallel
      assignment study, in which patients with Autism Spectrum Disorder (ASD) are two types of
      intervention by transcranial random noise stimulation (tRNS), to improve verbal fluency and
      empathy.
    

Detailed description: 
      Interventional, prospective, randomized, double-blind, placebo-controlled and parallel
      assignment study, in which patients receive three types of intervention tRNS: one group
      received 35 sessions focused on the fronto-temporal cortex, another group received 35
      sessions focused on the temporal fusiform cortex and last placebo group was operated with 35
      sessions tRNS. After brain noninvasive stimulation sessions, a blind analysis of the
      improvement in verbal fluency and empathy in patients with autism spectrum disorder is made.
      For each patient included a follow up period of three months will be established.
    

Intervention name(s): tRNS Fronto-temporal cortex; tRNS over fusiform temporal cortex; tRNS with sham
Intervention type(s): Device; Device; Device
Intervention description(s): This group receive 35 sessions of tRNS over fronto-temporal cortex; This group receive 35 sessions of tRNS over fusiform temporal cortex; the subjects receive 35 session with sham
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tRNS; QEEG; ERP; ASD; Autism; verbal fluency; empathy; noninvasive brain stimulation; tDCS
Stools and Life Habits Collection in Heathy Volunteers/Subjects - to Provide Material for in Vitro Model Development
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The purpose of this clinical study is to collect well characterized stools from healthy adult
      subjects, with completed life habits and alimentary questionnaires.
    


Intervention name(s): Stool collection
Intervention type(s): Other
Intervention description(s): There is no intervention with a product in this study. The healthy subject has just to come 2 times in the clinical trial unit for clinical exam including urinary pregnancy test, fill life habits and diet questionnaires, and provide one stool sample for the 2nd visit, after 2 weeks of alimentary restrictions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Stool collection; Human samples collection; Healthy subject; Life habits questionnaires; Diet questionnaires
Quetiapine Compared With Placebo in the Management of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      Is quetiapine more effective than other medications in the treatment of fibromyalgia.
    

Detailed description: 
      This study is a double blind, placebo controlled, 24-week crossover design. For 12 weeks
      subjects receive either study medication (200mg Quetiapine) or placebo, after which they will
      be switched to the other treatment for an additional 12 weeks. Between treatments, subjects
      are required to undergo a 1-week washout where no drug is given in order to clear the effects
      of the first treatment. At each visit subjects will complete the following assessment:
      Fibromyalgia Impact Questionnaire, Pittsburgh Sleep Quality Index, Beck Depression Inventory,
      State-Trait Anxiety Inventory, and Short Form Health Survey. Temperature, blood pressure,
      pulse rate, weight and waist circumference will also be recorded. Physical exams and blood
      tests will be performed at 1, 12, and 25 weeks
    

Intervention name(s): Quetiapine
Intervention type(s): Drug
Intervention description(s): 100 mg (peach colored oblong tablet) and 200 mg (yellow colored oblong tablet)
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fibromyalgia
Role of the Renin Angiotensin Aldosterone System in the Mechanisms of Transition to Heart Failure in Abdominal Obesity
Condition: Obesity, Abdominal
MeSH terms: Heart Failure; Obesity; Obesity, Abdominal
Study type: Interventional

Summary: 
      R2C2 study has shown that abdominal obesity is associated with a cardiac and vascular
      remodelling in healthy volunteers. This remodelling is correlated with renin-angiotensin
      aldosterone system (RAAS) activation and/or systemic fibrosis. R2C2 II study is designed to
      confirm the hypothesis that RAAS is associated with an early remodelling and implicated in
      the transition to cardiac failure in abdominal obesity.
    

Detailed description: 
      Follow up of abdominal obesity patients from the R2C2 cohort study.
    

Intervention name(s): Urine sample; Blood sample; Assessment of sleep apnea syndrome; Electrocardiogram; Glucose tolerance test; Echocardiography; cardiac and abdominal magnetic resonance imaging; Ambulatory blood pressure monitoring; Echotracking; Pulse wave velocity; Composition of body mass by Dual x-ray absorptiometry
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): dosages on one spot and 24h collection; dosages
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Heart failure, abdominal obesity, RAAS
Effects of the Use of Platelet-rich Fibrin on Bone Regeneration After Impacted Third Molar Surgery
Condition: Fibrin/Therapeutic Use; Blood Platelets; Molar, Third; Bone Regeneration
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the bone regeneration after impacted third molar
      surgery on split mouth design using platelet-rich fibrin.
    


Intervention name(s): Platelet-rich fibrin; Control group
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: platelet-rich fibrin; third molar; bone regeneration
Smoking-induced Dopamine Release: a [11C]-(+)-PHNO PET Study in Humans
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Observational

Summary: 
      This study will evaluate effects of smoking on the dopaminergic system by using PET
      tomography with new radioligand, [11C]-(+)-PHNO. Our primary hypothesis is that smoking a
      cigarette will produce dopamine release and this release can be measured using PET imaging
      and the [11C]-(+)-PHNO radiotracer. The secondary hypothesis is that this smoking induced
      dopamine release will be correlated with subjective craving and anxiety ratings.
    

Detailed description: 
      This will be a within-subjects study in healthy male and female smokers. There will be one
      within factor condition: Smoking and Non Smoking. Therefore, there will be a repeated measure
      of PET scans using [11C]-(+)-PHNO under two different conditions. Ten subjects (n=5 male and
      n=5 female) included in the study will come on two different days and will have a Smoking or
      Non smoking session performed just before the PET study. Subjective assessments will be
      conducted at each experimental condition.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy smokers
      
Biospecimen description: 
      Whole blood (15mL)
    
Keywords: Smoking-induced dopamine release; [11C]-(+)-PHNO PET Study
A Study Comparing SIBP-04 and Bevacizumab in Healthy Male Subjects
Condition: Healthy Male
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, double-blind, positive drug parallel controlled clinical trial in
      China. In the trial, it is planned to enroll 88 subjects, randomized to two treatment groups
      in a ratio of 1:1 to receive the test drug and the positive control.
    


Intervention name(s): SIBP-04; Bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): 3mg/kg, infusion in 90 minutes; 3mg/kg, infusion in 90 minutes
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pramipexole Dihydrochloride 0.25 mg Tablets Under Non-Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The object of this study was to compare the relative bioavailability (rate and extent of
      absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with
      that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc.
      following a single oral dose in healthy adults under non-fasting conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA Bioequivalence Statistical Methods
    

Intervention name(s): Pramipexole Dihydrochloride; Pramipexole Dihydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 0.25 mg Tablet; 0.25 mg Tablet
Other intervention name(s): Mirapex®
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
BI 443651 Methacholine Challenge
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to investigate safety and tolerability of three
      consecutive administrations, 12 hours apart, at three different dose-levels of BI 443651
      administered via oral inhalation in male and female mild asthmatic subjects after a bolus
      methacholine challenge.
    


Intervention name(s): BI 443651; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Three doses, each 12 hours apart; Three doses, each 12 hours apart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of the
      respiratory syncytial virus (RSV) candidate vaccine when first administered via intramuscular
      (IM) injection according to a 0, 1-month schedule to RSV-seropositive infants aged 12 to 23
      months.
    

Detailed description: 
      The RSV PED-002 study, designed to evaluate the safety, reactogenicity and immunogenicity of
      the RSV candidate vaccine when administered in 3 sequential doses to seropositive infants
      aged 12 to 23 months, will be conducted in an observer-blind manner in Epoch 1 and
      single-blinded in Epoch 2.
    

Intervention name(s): RSV (GSK3389245A) low dose formulation vaccine; RSV (GSK3389245A) middle dose formulation vaccine; RSV (GSK3389245A) high dose formulation vaccine; Placebo
Intervention type(s): Biological; Biological; Biological; Drug
Intervention description(s): 2 doses of 0.5 ml each of RSV (GSK3389245A) low dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.; 2 doses of 0.15 ml each of RSV (GSK3389245A) middle dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.; 2 doses of 0.5 ml each of RSV (GSK3389245A) high dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.; 2 doses (0.5 mL each for Placebo LD and Placebo HD groups and 0.15 mL each for Placebo MD group) of Placebo administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Respiratory syncytial virus (RSV); Immunogenicity; Reactogenicity; Infants; Vaccine
Use of ThermaCare Heat Wraps and Ibuprofen as an Adjunct to Physical Therapy for Neck Pain
Condition: Heat; Pain
MeSH terms: Neck Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective- To see if the use of heat at home between physical therapy sessions results in
      better therapy outcomes in people with acute neck pain.

      Setting: Physical Therapy outpatient rehabilitation center Participants: 90 people with acute
      nonspecific neck pain broken into 4 groups. Intervention: All subjects will undergo 45
      minutes of therapy 2 times per week for 2 weeks. All subjects will accomplish 1 hour of
      therapeutic exercise at home on days when there is no therapy. Thirty of the subjects will
      use ThermaCare neck wraps before home exercise, 30 used Ibuprofen plus ThermaCare neck wraps
      before home exercise, 15 will use a sham heat wrap and an Ibuprofen placebo each day (1200 mg
      / day) and the last 15 will be controls with conventional physical therapy.
    

Detailed description: 
      Neck pain patients admitted to an outpatient physical therapy program will be randomly
      assigned to either a control or 3 experimental groups. An initial evaluation and
      rehabilitation program will be established which includes a home exercise program. Therapy
      will be 2 days per week for 2 weeks. Thirty of the subjects will use ThermaCare continuous
      heat neck wraps applied for 6 hours before home exercise, 30 will use ibuprofen (1200 mg /day
      given in 3 dosages) plus ThermaCare neck wraps before home exercise, 15 will use a sham heat
      wrap and a Ibuprofen placebo each day and the last 15 will have conventional therapy.
      Intervention with heat or Ibuprofen will be used on days that they are not being treated in
      the clinic. All groups will be evaluated initially and after 2 weeks. They will be given home
      exercise and heat compliance logs and analog visual pain scales to be filled out each night
      before exercise and, if they used heat, before and after heat will be applied. The physical
      therapist will also be asked to evaluate their home compliance, pain and the benefit to them
      from the heat packs. Subjects will complete a neck disability questionnaire at the beginning
      and end of the study. At the end of the two weeks of treatment, a multivariate ANOVA will be
      performed to compare changes in home exercise compliance, functional level, pain level, range
      of motion, and strength. A statistical level of p≤.05 is considered predictive of a
      difference between groups.
    

Intervention name(s): thermacare heat wraps; Ibuprofen
Intervention type(s): Device; Drug
Intervention description(s): off the shelf thermacare continuous heat wraps made by thermacare to produce low level heat on the neck; 1200 mg ibuprofen administered 400mg at 4 hour intervals
Other intervention name(s): continuous low level heat; advil
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      30 adolescent girls and young women between 13 and 26 years with central adrenal
      insufficiency and a grand shortage of DHEA are recruit. The clinical trial is double-blind to
      show that the substitution of the hormone DHEA stimulates secondary hair growth, enhances
      well being and mood of the patients. It should also normalize the serum content of DHEA,
      aldosterone and testosterone.
    

Detailed description: 
      30 adolescent girls and young women between 13 and 26 years with central adrenal
      insufficiency and a grand shortage of DHEA are recruit. After randomization they either get
      DHEA or placebo for 12 months daily. The clinical trial is double-blind to show that the
      substitution of the hormone DHEA stimulates secondary hair growth, enhances well being and
      mood of the patients. It should also normalize the serum content of DHEA, aldosterone and
      testosterone.
    

Intervention name(s): Dehydroepiandrosterone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg DHEA, oral, once daily; placebo, oral, once daily
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Central Adrenal Insufficiency; DHEA; Pubes
Simvastatin Therapy in Women With Polycystic Ovary Syndrome.
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether statins (simvastatin) improve clinical
      (excessive hair, skin problems), endocrine (androgens) and metabolic (lipids, markers of
      systemic inflammation) in women with polycystic ovary syndrome (PCOS).
    


Intervention name(s): simvastatin
Intervention type(s): Drug
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; statin; testosterone; lipids