bioihbjkbjnl/mcl2 huggingface dataset:
NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this clinical evaluation is to evaluate the immediate and long-term (up to
      12 months) outcome of NanoCrossTM balloon catheter (Covidien) in a prospective,
      non-randomised, controlled investigation for the treatment of patients with critical limb
      ischemia (Rutherford 4-5) due to the presence of lesions of minimally 10cm in length at the
      level of the below-the-knee arteries.
    


Intervention name(s): NanoCross .014 balloon catheter
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral Arterial Disease; Infrapopliteal lesions; balloon catheter
Safety and Efficacy Study of Combretastatin A4 Phosphate to Treat Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
Condition: Choroidal Neovascularization; Myopia, Degenerative
MeSH terms: Myopia; Choroidal Neovascularization; Myopia, Degenerative; Neovascularization, Pathologic
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are to evaluate the safety and efficacy of 3 dose groups (27, 36
      and 45 mg/m2) of Combretastatin A-4 Phosphate for the treatment of subfoveal choroidal
      neovascularization in subjects with pathologic myopia.
    


Intervention name(s): Combretastatin A-4 Phosphate
Intervention type(s): Drug
Intervention description(s): Combretastatin A-4 Phosphate is administered on Day 0 and Day 7 (+/- 2 days). If the treating ophthalmologist notes any leakage from CNV in the study eye on a fluorescein angiography during the study or an increase in subretinal fluid on an optical coherence tomography measurement, retreatment with Combretastatin A-4 Phosphate is recommended with up to 3 additional treatments. The retreatment visit(s) could occur during a scheduled visit or at an additional visit 1 week after a regular study visit. A post-retreatment follow-up visit is necessary.
Other intervention name(s): CA4P; fosbretabulin
Intervention MeSH terms: Fosbretabulin; Combretastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: subfoveal choroidal neovascularization; pathologic myopia
Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis
Condition: Autoimmune Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Autoimmune
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a multicentre, multinational clinical study. It comprised two consecutive segments (A
      and B). Segment A was designed as a randomized, double-blind, double-dummy,
      active-controlled, two-arm parallel-group study. The patients received either budesonide or
      prednisone for 6 months. During segment B all patients received budesonide as an open
      treatment for additional 6 months.

      In this confirmatory study the proportion of patients with complete response was compared
      between the two treatment groups. Complete response was defined as biochemical remission
      (=serum levels of ASAT and ALAT within normal ranges) at the individual last visit of segment
      A and lack of steroid specific side effects throughout segment A.
    


Intervention name(s): budesonide; prednisone
Intervention type(s): Drug; Drug
Intervention description(s): 3mg capsule, 3x per day for 6 months; 5mg tablet, 40mg starting dose per day, titration to 10mg per day within 3 months
Intervention MeSH terms: Prednisone; Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Feasibility and Acceptability of Offering Self-sampling to Non-attendees in Primary Care
Condition: Cancer of the Uterine Cervix
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether human-papillomavirus (HPV) self-sampling
      can be used as a primary screening test for unscreened women.
    

Detailed description: 
      Women residing in the canton of Geneva, aged between 25 and 69 years, who haven't had a Pap
      test in the last three years, will be invited to participate. Participation to the study will
      be encouraged through public displays, social networks, and medical consultations. Women
      meeting the eligibility criteria will be enrolled in the study. They will be randomized into
      two groups and will receive a home-sent letter, inviting them to either come in for a Pap
      test or to perform and send back the HPV self-sample that they'll receive at their domicile.
      Both groups will also receive a questionnaire, in order to better understand the reasons for
      their previous non-attendance to cervical cancer screening.
    

Intervention name(s): Cobas HPV DNA Test; Papanicolau test
Intervention type(s): Device; Other
Intervention description(s): Women will receive a home-sent sample for HPV self-testing; Women will be invited to come in for a physician-performed Pap test
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Dose Finding of Quetiapine Fumarate 200mg vs 400mg in First Episode Psychosis
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is determine the minimal effective dose and the impact on:

        1. treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients
           experiencing the first psychotic episode

        2. the final maintenance doses

        3. the use of other medications

        4. the amount of changes to other antipsychotic medication

        5. the number of hospitalization days
    


Intervention name(s): Quetiapine Fumarate
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: First Episode Psychosis
Evaluation of Brain Atrophy in CIS Patients on Avonex
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Atrophy
Study type: Observational

Summary: 
      The purpose of this study is

        -  To examine if Avaonex can delay the development of clinically definite multiple
           sclerosis.

        -  To investigate if Avonex can delay disability progression by slowing brain atrophy.
    

Detailed description: 
      -  Multiple sclerosis (MS) is a chronic inflammatory disorder characterized by focal areas
           of demyelination in the central nervous system (CNS). MRI findings suggest that we
           should look at gray matter atrophy as a marker of the disease process in MS.

        -  Avonex is a proven effective disease-modifying treatment, which reduces total brain and
           GM atrophy and should be considered first-line therapy in patients with RRMS and CIS.

        -  The original SET study is an open-label observational study of high risk subjects after
           CIS for development of CDMS that will enroll 220 patients who have started Avonex
           immediately after their first clinical attack in Czech Republic, and are followed with
           clinical and MRI examinations for 4 years at 0, 6, 12, 24, 36 and 48 months. The
           clinical and MRI acquisition examinations of this study are conducted in Czech Republic.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Multiple sclerosis patients being treated with Avonex after first clinical attack.
      
Keywords: Multiple Sclerosis; Avonex; Brain atrophy; MRI; Interferon-beta 1a; IFN Beta 1-a; Clinically isolated syndrome; CIS
Assessing the Occupation Burden in COPD
Condition: Lung Diseases, Obstructive; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      To assess the population burden of occupational exposures in the prevalence and progression
      of chronic obstructive pulmonary disease (COPD).
    

Detailed description: 
      BACKGROUND:

      Chronic obstructive pulmonary disease is the only one of the top four or five leading causes
      of death in the U.S. with worsening epidemiological trends. Cigarette smoking accounts for
      approximately 85 percent-90 percent of cases, but the other 10 percent-15 percent of the
      attributable risk still represents a substantial fraction of this disease that remains
      unexplained. Recently, several studies, in various countries, have addressed whether certain
      occupational exposures (primarily those relating to dusts, vapors, gases, and/or fumes) are
      potential risk factors for COPD. Most of these studies have shown elevated odds ratios or
      relative risks, although not always to a statistically significant level.

      DESIGN NARRATIVE:

      A population sample of the continental United States of those aged 55-75, supplemented by an
      enriched sample in geographic "hot spots" identified by the National Institute for
      Occupational Safety and Health (NIOSH) through respiratory diseases mapping. Structured
      telephone interviews assessed demographics, health status, smoking exposures, and
      occupational histories. High risk jobs were coded using a job matrix system independent of
      subject report of specific exposures. Two hundred thirty-four of those with COPD, with
      over-sampling of those with greater severity, were followed at 12-14 months to assess health
      status and health services utilization, as well as decrements in quality of life.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and tolerability of E5555 in Japanese
      patients with acute coronary syndrome.
    


Intervention name(s): E5555; E5555; E5555; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): E5555, 50 mg (tablet), taken orally, once a day.; E5555, 100 mg (tablet), taken orally, once a day.; E5555, 200 mg (tablet), taken orally, once a day.; Placebo tablet taken orally, once a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Platelet Aggregation Inhibitors; Coronary Stenosis; Coronary Thrombosis
Compare the Operating Condition of Two Levels of Muscle Relaxation on Facial Nerve MEP Monitoring in CPA Surgery
Condition: Cerebellopontine Angle Tumor
MeSH terms: Neuroma, Acoustic
Study type: Interventional

Summary: 
      compare the operating condition of two different levels of muscle relaxation on facial nerve
      monitoring using transcranial motor evocked potential in CPA surgery .

        -  To Estimate End to start facial nerve MEP amplitude ratio

        -  To determine the effect of neuromuscular relaxant degrees on recovery and

        -  Assessment of propofol doses needed for enhancement of early recovery and ambulation.
    

Detailed description: 
      40 Patients aged from 18-60 years old undergoing Cerebellopontine angle surgery. Patients
      will be one of two groups: Both Induction will be accomplished with fentanyl, propofol ,
      rocronium infusion will be given randomly to one of the groups.

      Depth of anaesthesia, neurotransmitter monitoring and facial nerve neurophysiological
      monitoring will be done.
    

Intervention name(s): Rocroniom, Non Depolarizing Muscle Relaxant
Intervention type(s): Drug
Intervention description(s): compare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery
Other intervention name(s): Nerve stimulator for train of four assessment; BIS bispectral index
Intervention MeSH terms: Neuromuscular Nondepolarizing Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Screening
Mild Water-Filtered Near Infrared Whole-Body-Hyperthermia as an Adjunct in the Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Hyperthermia; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate whether mild walter-filtered near infrared
      hyperthermia produces an additional benefit when applied as an adjunct to standard multimodal
      rehabilitation compared to standard multimodal rehabilitation only in patients with
      fibromyalgia.
    

Detailed description: 
      Mild systemic heat agents, including infrared whole-body hyperthermia, are used as treatment
      options in multimodal rehabilitation programs for fibromyalgia in Germany. However, no
      randomized controlled clinical trial exists on their effectiveness for this condition.

      This study is designed as an add-on study to evaluate the additional benefit of mild
      walter-filtered near infrared hyperthermia and a standard multimodal rehabilitation program
      compared to a standard multimodal rehabilitation program only. Standard multimodal
      rehabilitation is configured as usually applied in clinical trials with exercise, cognitive
      behavioral therapy, and health education as the main treatment components.

      Mild walter-filtered near infrared hyperthermia (heating-up to 38.1 degrees C body core
      temperature followed by a 15-min heat retention period) is administered twice a week over 3
      weeks during a rehabilitation hospital stay.

      Primary outcome measures are measured at baseline, postintervention, 3 and 6 months
      postintervention. Analysis is done by intention to treat, for significance testing Repeated
      Measures ANCOVA is used.
    

Intervention name(s): Iratherm® 1000
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibromyalgia; Rehabilitation; Physical Medicine; Whole-Body Hyperthermia; Water-Filtered Near Infrared
Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of three doses of the probiotic B.
      subtilis (Bacillus subtilis R0179) delivered in capsules on gastrointestinal and general
      wellness in healthy young adults, survival through the gastrointestinal tract and impact on
      intestinal microbes.
    

Detailed description: 
      A 6 week randomized, double blind placebo controlled trial in healthy young adults aged 18 to
      50. Participants will be administered an oral dose of B. subtilis or placebo (1 capsule/day)
      for a period of 4 weeks. Viable counts will be measured from stool samples to assess transit
      survival, daily questionnaires (DQ) will be administered to assess general wellness, and
      gastrointestinal (GI) symptoms will be evaluated three times with the Gastrointestinal
      Symptom Response Scale (GSRS) questionnaire.
    

Intervention name(s): B. subtilis R0179; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): B. subtilis R0179 for a period of 4 weeks. One capsule per day.; Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: probiotics; microbiota; survival; gastrointestinal; wellness
Treatment for Children With Autism and Anxiety
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      Children with high-functioning autism spectrum disorders (ASD) are at high risk for
      developing significant anxiety symptoms. Cognitive behavior therapies (CBT) are frequently
      used for children with anxiety symptoms with good success. The purpose of the current study
      was to examine the efficacy of a family-focused group CBT program (Facing Your Fears [FYF])
      compared to Treatment As Usual (TAU). Participants were randomized to either active treatment
      or TAU. It was hypothesized that children who completed the active treatment would
      demonstrate improvement in their anxiety symptoms relative to children in TAU.
    

Detailed description: 
      Children with ASD and anxiety in our initial studies have displayed reductions in anxiety
      symptoms following the delivery of the FYF intervention. Given these initial successes, there
      are two primary purposes of this study. First, to train outpatient clinicians to fidelity on
      the FYF intervention for 8-14 year old children with high-functioning ASD and clinical
      anxiety. Second, to develop an optimal training model for learning the FYF intervention. The
      primary aims of Phase 1 are to develop a training manual and deliver a workshop on the FYF
      model to a group of outpatient clinicians in preparation for the clinicians to deliver the
      FYF intervention to four groups of children with ASD and anxiety. In Phase 2, the primary
      aims include comparing three instruction methods of learning to clinicians at three different
      outpatient clinics, by assessing increases in clinicians' acquisition of the intervention
      techniques and estimating the degree of reduction in anxiety symptoms on the primary outcome
      measures for the children with ASD. Instruction methods are: a) Manual, b) Workshop, c)
      Workshop-Plus. We hypothesize that clinicians receiving the Workshop-Plus (workshop plus
      ongoing consultation) condition will achieve treatment fidelity at a faster rate than
      clinicians receiving the other two instruction methods, and the children with ASD in the
      Workshop-Plus condition will display greater reductions in anxiety symptoms compared to the
      children in the other two conditions.
    

Intervention name(s): Facing Your Fears
Intervention type(s): Behavioral
Intervention description(s): FYF is a group cognitive behavior therapy that includes parent and child participation. Groups meet weekly for 1 1/2 hours duration, for 14 consecutive weeks.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Study type: Interventional

Summary: 
      This pilot study is intended to assess feasibility of auricular acupuncture in NAS infants
      who require pharmacologic therapy. We intend to evaluate acceptability of auricular
      acupuncture, infant tolerance, recruitment strategies, and methodological issues. We plan to
      also test and generate hypotheses in preparation to apply for funding a larger randomized
      controlled trial.
    

Detailed description: 
      Objectives:

      Primary: To establish feasibility of a protocol for auricular acupuncture in infants
      suffering from NAS admitted to the NICU receiving pharmacologic therapy.

      Secondary: In infants suffering from NAS admitted to the Neonatal Intensive Care Unit (NICU)
      receiving pharmacologic therapy:

        1. Determine parent and staff acceptability of auricular acupuncture

        2. Determine infant tolerance to auricular acupuncture

        3. Evaluate the effect of auricular acupuncture on individual items of the Modified
           Finnegan Neonatal Abstinence Severity score associated with sympathetic nervous system
           responses

        4. Evaluate the effect of auricular acupuncture on time to return to birth weight
    

Intervention name(s): Acupuncture
Intervention type(s): Other
Intervention description(s): Acupuncture
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Acupuncture
A Study to Evaluate the Efficacy After Allergen Challenge, Safety and Tolerability of Inhaled CHF6001 DPI in Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to look at the safety, tolerability and efficacy of 2 different doses
      of the study drug (CHF6001, a PDE4 inhibitor) in asthmatics, when given by inhalation, once a
      day for 9 days. The efficacy will be evaluated by measuring the protective effect of CHF 6001
      after an allergen challenge.
    


Intervention name(s): CHF6001; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PDE4 inhibitor; Allergen Challenge; Asthma
Impact of Intermittent Hypoxia and Prednisolone on Motor Performance in Persons With SCI
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Hypoxia
Study type: Interventional

Summary: 
      The objective of this study is to examine the effects of mild acute intermittent hypoxia
      (AIH) in combination with an anti-inflammatory drug (i.e. prednisolone) on motor performance
      in persons with spinal cord injury (SCI).
    


Intervention name(s): Prednisolone + Acute Intermittent Hypoxia; Placebo + Acute Intermittent Hypoxia
Intervention type(s): Other; Other
Intervention description(s): Administration of oral prednisolone followed by 15, 60-second bouts of mild hypoxia; Administration of oral matching placebo followed by 15, 60-second bouts of mild hypoxia
Intervention MeSH terms: Prednisolone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy Study of Oxazolidinone to Treat Pneumonia
Condition: Community-Acquired Pneumonia (CAP)
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether RX-1741, an oxazolidinone antibiotic, is
      safe and effective in the treatment of mild to moderate community acquired pneumonia (CAP).
    


Intervention name(s): Radezolid; Radezolid; Radezolid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 300 mg/day, orally for 7-10 days; 450 mg/day orally for 7-10 days; 900 mg/day orally for 7-10 days
Other intervention name(s): RX-1741; RX-1741; RX-1741
Intervention MeSH terms: Radezolid; Oxazolidinones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment