bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Treadmill Gait Training With Loading in Individuals With Stroke
Condition: Stroke; Gait Disorders, Neurologic
MeSH terms: Stroke; Nervous System Diseases; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the add load on non-paretic lower limb of
      individuals that suffer a stroke, while walking on a treadmill, is effective for restore gait
      symmetry of these individuals, in a subacute phase of stroke.
    

Detailed description: 
      This is a randomized and blinded clinical trial, in which participants are being randomly
      divided into experimental group and control group, in order to verify the effects of adding
      load on gait symmetry after stroke. 40 individuals will participate, and the calculation of
      sample size was performed from the ratio variable symmetry of swing time, based on previous
      study. Whereas about 15% of individuals could give up to participate in the study during
      their course (dropout rate), we determined a number of 20 participants in each group.
    

Intervention name(s): Treadmill, ankle load; Treadmill
Intervention type(s): Other; Other
Intervention description(s): The experimental group will perform gait training on a treadmill (Gait Trainer 2®) with added load to the ankle of the non-paretic lower limb, plus physical therapy correction for restore gait symmetry. The intervention will last 30 minutes, in nine sessions for two weeks; The control group (active comparator) will perform gait training on a treadmill (Gait Trainer 2®) with physical therapy correction for restore gait symmetry. The intervention will last 30 minutes, in nine sessions for two weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Gait; Rehabilitation
Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.
      The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to
      cervical cancer in women. This study will evaluate the immunogenicity and safety of the
      HPV-16/18 L1 VLP AS04 vaccine.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      The protocol was primarily amended for the following reasons:

        -  Merck's tetravalent HPV vaccine, Gardasil®, has been licensed and is now becoming
           commercially available in an increasing number of countries. Therefore, the study
           procedures were revised to include questions at every visit to determine if subjects
           have received an HPV vaccine outside of the study.

        -  It was decided to offer GSK Biologicals' HPV vaccine to all subjects in the control
           group at the end of the study. The HPV vaccine will be offered to these subjects based
           on its local indication once the vaccine is marketed in Malaysia.
    

Intervention name(s): Placebo; HPV-16/18 L1 VLP AS04 (Cervarix TM)
Intervention type(s): Biological; Biological
Intervention description(s): Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.; Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Other intervention name(s): GSK Biologicals' HPV-16/18 VLP/AS04 vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HPV-16/18 L1 VLP AS04; Cervical neoplasia; Cervical cancer; Human Papillomavirus (HPV); Double-blind; AS04
High Flow Nasal Cannula in Preterm Infants
Condition: Prematurity; Extreme
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The HIFLO study evaluates the impact of HFNC oxygen therapy on duration of nCPAP therapy,
      oxygen therapy and hospitalization. The cost of use of CPAP and two HFNC devices are also
      evaluated.
    

Detailed description: 
      Nasal continuous positive airway pressure (nCPAP) is widely used in preterm infants as it is
      efficient, but it creates an unfavorable environment for preterm infants. Indeed is a primary
      source of continuous noise in neonatal units and causes discomfort, pain, skin lesions. High
      flow nasal cannula (HFNC) introduced more recently in neonatal care supplies high allowing
      for carbon dioxide nasopharyngeal wash-out, reduction of work of breathing and is well
      tolerated. HFNC could help to improve the environment of preterm infants by reducing
      deleterious stimuli (noise, pain, discomfort) and by facilitating the contact between parents
      and babies. Efficacy of HFNC seems to be similar to other non-invasive respiratory supports
      for preventing treatment failure, death and bronchopulmonary dysplasia. The benefits of HFNC
      implementation was only slightly analyzed in extremely preterm infants. the place of HFNC is
      becoming increasingly important in neonatology and could help to improve the quality of care.
      Few HFNC devices are available but their cost of use has not been evaluated in Europe.

      HIFLO study aimed to assess the impact of HFNC therapy introduction, on exposure to nCPAP and
      on the duration of oxygen therapy and hospital stay in preterm infants and in a subgroup of
      extremely preterm infants. The investigators also aim to evaluate the cost of use of nCPAP
      and HFNC using two different devices.
    

Intervention name(s): High flow nasal cannula
Intervention type(s): Other
Intervention description(s): High flow nasal cannula added to the therapeutic arsenal in neonatal care
Other intervention name(s): HFNC
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All preterm infants born during year 2011 and year 2014, before 32 weeks of gestational age
        (GA) or with a birth weight below 1500 g, hospitalized within the first 48 hours of life in
        the tertiary care unit at Croix-Rousse Hospital, Lyon, France and discharged home from the
        unit.
      
Keywords: high flow nasal cannula; nasal continuous positive airway pressure; noninvasive ventilatory support; newborn developmental care; bronchopulmonary dysplasia; weaning; pain; length of stay
Effect of Oral Supplementation With Probiotics
Condition: Obesity
MeSH terms: Obesity; Metabolic Syndrome
Study type: Interventional

Summary: 
      Effect of oral supplementation with probiotics on cardiometabolic risk factors, microflora
      and intestinal epithelial permeability, mineral content and lifestyle in obese women with
      postmenopausal metabolic syndrome: double-blind, randomized clinical trial.
    

Detailed description: 
      The purpose of the study is to determine whether oral probiotic supplementation affects
      cardiometabolic risk, intestinal epithelial permeability, metabolic activity and intestinal
      flora composition, mineral content, and lifestyle in obese women with metabolic syndrome.

      Probiotics are a group of non-pathogenic microbes that bring health benefits to the host.
      Their use enables the variety and proper functioning of intestinal microflora. The use of
      probiotics increases the amount of bifidobacteria and lactobacilli, what directly affects the
      reduction of endotoxemia by sealing the intestinal wall, as well as the improvement of fat,
      carbohydrate and insulin metabolism.

      The project is due to evaluate the effect of supplementation with selected probiotics in
      patients with metabolic syndrome on:

        -  lipid metabolism- total cholesterol, HDL and LDL cholesterol and triglycerides,

        -  blood glucose concentration,

        -  blood pressure values,

        -  anthropometric parameters,

        -  quality of life,

        -  the contentl of minerals,
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: probiotics; metabolic syndrome; obesity; microbiome
Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
Condition: Vulvovaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      The purpose of this study is to assess the safety and the efficacy of a laser in the
      treatment of vulvovaginal atrophy (VVA), that is to assess the change in the severity of the
      vaginal dryness symptom, by means of a visual analogic scale (10 cm VAS).
    

Detailed description: 
      The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will
      be delivered through the handpiece. Subjects will receive a total of three (3) treatments
      every six (6) weeks (+/-1 week). Subjects will return one week (+/- 3 days) post the first
      treatment, as well as three (3) months (+/- 2 weeks) and twelve (12) months (+/- 2 weeks)
      post the third treatment.
    

Intervention name(s): Laser treatment
Intervention type(s): Device
Intervention description(s): The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Irbesartan, Ciprofibrate and Their Combination Onto the Endothelial Functions
Condition: Hypertension; Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The rationale of the study is to clarify whether the supplementation of irbesartan with
      ciprofibrate could increase the antihypertensive effect, could improve the endothelial
      functions, and/or could affect the atherogenic small-dense LDL-, oxydized LDL concentrations,
      onto the paraoxinase activity and on the CRP and insulin levels.
    


Intervention name(s): Irbesartan; Ciprofibrate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Irbesartan; Ciprofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy
Condition: Malignant Melanoma, Neoplasms
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of
      multiple doses of vemurafenib on the pharmacokinetics of a single dose of acenocoumarol in
      participants with BRAFV600 mutation-positive metastatic malignancies. Participants will
      receive a single dose of acenocoumarol 4 mg orally on Day 1 and Day 23, vemurafenib 960 mg
      orally twice daily on Days 4-26. After completion of pharmacokinetic assessments on Day 26,
      eligible participants will have the option to continue treatment with vemurafenib as part of
      an extension study (GO28399 [NCT01739764]).
    


Intervention name(s): acenocoumarol; vemurafenib
Intervention type(s): Drug; Drug
Intervention description(s): 4 mg single oral doses on Days 1 and 23; 960 mg orally bid, 20 days (Days 4-23)
Other intervention name(s): Zelboraf
Intervention MeSH terms: Vemurafenib; Acenocoumarol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis
Condition: Osteoarthritis of the Knee; Insomnia; Knee Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose if the study is to determine whether improving sleep, especially slow wave or
      "deep" sleep, in older adults with osteoarthritis (OA) and insomnia reduces pain sensitivity
      and inflammatory responses to pain, and improves OA-related pain.
    


Intervention name(s): Cognitive Behavioral Therapy for Insomnia
Intervention type(s): Behavioral
Intervention description(s): 6-week behavioral treatment for insomnia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Osteoarthritis; Insomnia; Chronic pain; Cognitive Behavioral Therapy for Insomnia; Inflammation; Inflammatory cytokines
Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo
Condition: Cardiovascular Diseases; Statin Adverse Reaction
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus
      placebo decreases the risk of cardiovascular events in participants who have or are at high
      risk for cardiovascular disease and are statin intolerant.
    


Intervention name(s): Bempedoic acid 180 mg tablet; Matching placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): Patients take bempedoic acid 180 mg tablet orally once daily; Patients take matching placebo tablet orally once daily
Other intervention name(s): ETC-1002; placebo comparator
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 2 Study to Evaluate Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2, Randomized, Double-Blind, Placebo- and Comparator-Controlled Trial to Evaluate the
      Safety and Efficacy of Combination Pregabalin and Acetaminophen Compared to Acetaminophen and
      Placebo in Subjects Undergoing Bunionectomy
    

Detailed description: 
      A Phase 2, Randomized, Double-Blind, Placebo- and Comparator-Controlled Trial to Evaluate the
      Safety and Efficacy of Combination Pregabalin and Acetaminophen Compared to Acetaminophen and
      Placebo in Subjects Undergoing Bunionectomy

      Up to 80 subjects will be randomized (32 in each active treatment group, 16 placebo).

      To evaluate the efficacy of combination pregabalin (PGB) and acetaminophen (APAP)
      administered vs. placebo for pain control in subjects undergoing bunionectomy.

      The placebo will be the saline solution.
    

Intervention name(s): Pregabalin; Acetaminophen; Placebo 1; Placebo 2
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid with anticonvulsant, anxiolytic and sleep-modulating properties.; Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent.; Placebo for APAP; Placebo for combination
Other intervention name(s): PGB; APAP
Intervention MeSH terms: Acetaminophen; Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
Condition: Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single
      administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal
      dialysis.
    


Intervention name(s): KHK7580
Intervention type(s): Drug
Intervention description(s): Oral administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
Effect of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To evaluate the effects of rifampicin on the pharmacokinetics (PK) of sotagliflozin and its
      metabolite in healthy male and female subjects.

      Secondary Objectives:

        -  To assess total 24-hour urinary glucose excretion (UGE) after a dose of sotagliflozin
           400 mg, alone and with rifampicin, in healthy male and female subjects.

        -  To assess the safety and tolerability of single dose sotagliflozin with and without
           rifampicin in healthy male and female subjects.
    

Detailed description: 
      The expected duration of the study is approximately 53 days total, including 2-28 days of
      screening, treatment periods of 6 days and 11 days, 1 day of end of study visit, and at least
      7 days of follow-up visit.
    

Intervention name(s): Sotagliflozin (SAR439954); Rifampicin
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: tablets
Route of administration: oral; Pharmaceutical form: capsules
Route of administration: oral
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Healthy Volunteer Study To Assess Relative Bioavailability Of Powder-In-Capsule And A Tablet Formulation And The Effect Of Food On The Pharmacokinetics Of The Tablet Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study in healthy volunteers is to assess the relative bioavailability of
      PF-05175157 as powder-in-capsule and a tablet formulation and the effect of food on the
      pharmacokinetics of the tablet formulation.
    


Intervention name(s): PF-05175157; PF-05175157; PF-05175157; PF-05175157
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single 200 mg dose of PF-05175157 administered as powder in capsule (2x100 mg); Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg); Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg); Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Single dose; Relative Bioavailability; Food effect; Healthy subjects; Diabetes Mellitus Type 2
Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether a single IV dose of N6022 will have a
      significant bronchoprotective effect, compared with placebo, during methacholine challenge.
    

Detailed description: 
      The number of patients with adverse events measured in both the treated and placebo groups
      from start of dosing until Day 28 post dose.
    

Intervention name(s): Active; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A 5 mg single dose given intravenously via syringe pump over 1 minute.; Same as active
Other intervention name(s): N6022
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Prophylactic Hepatitis B Vaccine
Condition: Vaccine-Preventable Diseases; Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Vaccine-Preventable Diseases; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of the investigational
      medicinal product, CVI-HBV-002.
    

Detailed description: 
      A Randomized, Open-labelled, Parallel, Phase 1 clinical study to evaluate the safety,
      reactogenicity and immunogenicity of the hepatitis B vaccine CVI-HBV-002 in adults
    

Intervention name(s): CVI-HBV-002
Intervention type(s): Biological
Intervention description(s): Investigational Product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Antiglutamate Anticonvulsants in the Treatment of Alcohol Withdrawal Syndrome
Condition: Topiramate; Lamotrigine; Memnatine; Diazepam; Placebo
Study type: Interventional

Summary: 
      The study is aimed to evaluate the efficacy of antiglutamate anticonvulsants (topiramate,
      lamotrigine, and memantine) in the treatment of alcohol withdrawal syndrome
    


Intervention name(s): Anticonvulsants
Intervention type(s): Drug
Intervention MeSH terms: Anticonvulsants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment