bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin
Condition: Type 2 Diabetes; Hyperlipidemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      A 16 week open-label study with subjects receiving background metformin monotherapy. 150
      subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open
      label rosiglitazone, or open-label sitagliptin.
    


Intervention name(s): Colesevelam HCl; rosiglitazone maleate; sitagliptin phosphate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): coleveselam tablets 625 mg; 6 tablets/day; rosiglitazone tablets 4mg; sitagliptin phosphate tablets 100mg/day
Intervention MeSH terms: Sitagliptin Phosphate; Rosiglitazone; Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colesevelam HCl,; rosiglitazone; sitagliptin; Type 2 diabetes; metformin
A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the pharmacokinetic (PK) parameters of teriflunomide after a single oral dose of 14
      mg administration in Chinese healthy subjects

      Secondary Objective:

      To assess the safety and tolerability after a single oral dose of 14 mg teriflunomide in
      Chinese healthy subjects
    

Detailed description: 
      -  Screening: 2 to 21 days before inclusion (Day -21 to Day -2)

        -  Institutionalization period: 6 days including 1 treatment day (Day -1 to Day 6,
           treatment on Day 1)

        -  Follow-up: 7-10 days (may be extended)

        -  End of study: Day 38 to Day 41 (may be extended)

        -  Total study duration: maximum 9 weeks
    

Intervention name(s): Teriflunomide HMR1726; cholestyramine
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:tablet Route of administration: oral; Pharmaceutical form:power Route of administration: oral
Intervention MeSH terms: Teriflunomide; Cholestyramine Resin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, multi-center, extension study for patients with IPF who complete a
      qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain
      additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a
      qualifying InterMune clinical trial of pirfenidone.
    

Detailed description: 
      This is an open-label, multi-center, extension study for patients with IPF who complete a
      qualifying InterMune clinical trial of pirfenidone. Eligible patients must complete the final
      visit for their qualifying study, have not permanently discontinued study drug in their
      qualifying study, and meet all of the eligibility criteria noted in this protocol.

      Since data from the qualifying study may remain blinded during patient enrollment in
      PIPF-012, all patients will be treated as if they were taking placebo in their qualifying
      study. At the start of PIPF-012 participation, each patient will escalate the dose of
      pirfenidone.

      The duration of treatment for each patient will vary and will continue until pirfenidone is
      commercially or otherwise available in his/her geographic region or the study is terminated
      by the sponsor for reasons outlined in the protocol.
    

Intervention name(s): pirfenidone
Intervention type(s): Drug
Intervention description(s): Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.
Intervention MeSH terms: Pirfenidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: idiopathic; pulmonary; fibrosis
Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy
Condition: Coughing
MeSH terms: Cough
Study type: Interventional
Phase: Phase 4

Summary: 
      Coughing during emergence from general anaesthesia may lead to dangerous effects including
      laryngospasm, detrimental haemodynamic changes. Post-thyroidectomy bleeding occurs in 1-4% of
      patients, and severe coughing may cause bleeding. Dexmedetomidine, a potent α adrenoreceptor
      agonist, is theoretically appropriate for reducing airway and haemodynamic reflexes during
      emergence from anaesthesia.

      In this study, we investigated whether intravenous single-dose dexmedetomidine at the end of
      surgery reduces coughing during extubation after thyroidectomy.
    


Intervention name(s): Dexmedetomidine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously) at time of muscle layer closing.; We administrate the normal saline (single bolus, 0.25ml/kg) intravenously at time of muscle layer closing.
Other intervention name(s): Precedex; Normal saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Vaccine Plus Montanide ISA-51 and Sargramostim in Treating Patients With Stage IV Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Giving a
      vaccine with Montanide ISA-51 and sargramostim may cause a stronger immune response and kill
      more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy
      when given together with Montanide ISA-51 and sargramostim in treating patients with stage IV
      breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the safety of telomerase: 540-548 peptide vaccine emulsified in Montanide
           ISA-51 and sargramostim (GM-CSF) in patients with HLA-A2-expressing stage IV breast
           cancer.

      Secondary

        -  Compare the generation of human telomerase reverse transcriptase (hTERT)
           peptide-specific vs cytomegalovirus peptide-specific cytotoxic T-lymphocyte (CTL)
           immunity in patients treated with this regimen.

        -  Correlate the dose level of this regimen with the generation of hTERT-specific CTL
           immunity and the development of hTERT-specific autoimmunity in these patients.

        -  Determine the tumor response in patients treated with this regimen.

      OUTLINE: This is a dose-escalation study of the telomerase: 540-548 peptide and CMV 495
      peptide portions of the vaccine.

      Patients receive telomerase: 540-548 peptide and CMV 495 peptide (as an immunological
      control) vaccine emulsified in Montanide ISA-51 subcutaneously (SC) followed by sargramostim
      (GM-CSF) SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, and 27 (for a total of 8 vaccinations).
      Treatment continues in the absence of disease progression or unacceptable toxicity.

      Cohorts of 5-8 patients receive escalating doses of telomerase: 540-548 peptide and CMV 495
      peptide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
      preceding that at which 2 of 5 or 2 of 8 patients experience dose-limiting toxicity. A total
      of 12 patients receive treatment at the MTD.

      Patients are followed within 30 days and then at 6 and 12 months.

      PROJECTED ACCRUAL: A total of 5-28 patients will be accrued for this study.
    

Intervention name(s): incomplete Freund's adjuvant; sargramostim; telomerase: 540-548 peptide vaccine
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: Sargramostim; Freund's Adjuvant
Primary purpose: Treatment
Keywords: recurrent breast cancer; stage IV breast cancer
Phase I of BIBW 2992/BIBF 1120 Combination Therapy in Solid Tumors
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to determine the MTD of the combination of BIBW
      2992/BIBF 1120 therapy administered concomitantly in a 28-day cycle schedule.

      Secondary objectives are the collection of antitumor efficacy data, the determination of
      pharmacokinetic parameters of BIBF 1120 and BIBW 2992, and if data allow the determination of
      the pharmacokinetic influence of BIBW 2992 on BIBF 1120 and vice versa.
    


Intervention name(s): BIBW 2992; BIBF 1120
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nintedanib; Afatinib
Primary purpose: Treatment
Mirror Therapy and Cross-Education of Muscle Strength
Condition: Cerebrovascular Stroke; Muscle Weakness
MeSH terms: Muscle Weakness; Stroke
Study type: Interventional

Summary: 
      This study was conducted to determine whether mirror therapy has an additive effect on
      cross-education of the strength of neuromuscular electrical stimulation (NMES) in patients
      with hemiplegia. As an outcome measure, the ankle dorsiflexion strength of hemiplegic
      patients was measured.
    

Detailed description: 
      A total of 29 patients, 7 women, and 22 men were included according to the inclusion and
      exclusion criteria. The patients were randomly assigned to the control group (n = 14) and the
      Mirror group (n = 15). Five sessions of neuromuscular electrical stimulation, unaffected side
      ankle dorsiflexors were applied to the patients in both groups. In addition to the NMES,
      mirror therapy was applied to the experimental group simultaneously with NMES. Before and
      after treatment, both ankle dorsiflexor strength was measured with a force sensor. For force
      measurements, a force transducer (FC2211-0000-0100-L Compression Load Cell, TE Connectivity
      company, France) was used. Force transducer signals were received with a data acquisition
      device (POWERLAB® data acquisition system ADInstruments, Oxford, UK) and evaluated offline on
      the computer. The measurement values were expressed in kilogram.force (kg.f) and this value
      was normalized according to body weight.
    

Intervention name(s): Mirror frame; Control
Intervention type(s): Device; Device
Intervention description(s): Combined Mirror and NMES therapy; Only NMES therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cross-education; Neuromuscular electrical stimulation; Mirror Therapy
The Effect of Covid-19 on the Disease Course of Multiple Sclerosis :Belgian Lessons Learned From Rocky I to Rocky IV
Condition: COVID-19
MeSH terms: COVID-19; Multiple Sclerosis; Disease Progression
Study type: Observational

Summary: 
      Retrospective observational cohort study. ToFCoMS: two years of follow-up of COVID-19 in MS.
    

Detailed description: 
      Methods The Nationaal Multiple Sclerose Centrum (NMSC) Melsbroek is a large
      highly-specialized center specifically focusing on neurological management, multidisciplinary
      care and rehabilitation in patients with MS. Since March 2020 (i.e., the onset of the
      pandemic in Belgium, and the first of five waves of spiking infection numbers thus far in our
      country), clinical data of patients followed at the center have been collected in a local
      database in case of COVID-19 diagnosis. The following items have been recorded: name, gender
      and date of COVID-19 diagnosis; age, Expanded Disability Status Scale score, MS duration,
      clinical subtype and DMT regimen at time of COVID-19 diagnosis; COVID-19 severity (method 1:
      categorized as ambulatory, hospitalized, death; method 2: categorized as asymptomatic, mild
      illness, moderate illness, severe illness, critical illness and death); vaccination status
      (categorized as non-vaccinated, fully vaccinated, fully vaccinated + booster) at time of
      COVID-19 diagnosis. On February 28, 2022, this database was locked and consisted of 234180
      unique individual COVID-19 cases.

      The NMSC Melsbroek features a second and more large database containing a broad variety of
      (para)clinical information gathered during routine follow-up, which includes regular testing
      of general disability with the EDSS, leg function/ambulation with the Timed 25-Foot Walk Test
      (T25FWT), hand function/dexterity using the 9-Hole Peg Test (9HPT) and cognition/information
      processing speed with the Symbol Digit Modalities Test (SDMT). For each of these parameters,
      the first two assessments before COVID-19 diagnosis (labelled T0 and T1, respectively; T1 is
      the closest to COVID-19 diagnosis), and the first thereafter (labelled T2), were retrieved
      for each COVID-19 subject. If clinical measurements were performed during an in-house stay
      for rehabilitation purposes, only those performed on admission were retained (thus not
      necessarily those the closest to the COVID-19 infection).
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        MS patients with Covid 19 infection
Medipore Tape Study
Condition: Scarring
MeSH terms: Cicatrix
Study type: Interventional

Summary: 
      This is a prospective, single-blinded, two-arm, randomized, parallel, pragmatic,
      effectiveness trial that will enroll patients undergoing arthroscopic anterior cruciate
      ligament reconstruction in order to evaluate the efficacy of using Medipore tape to improve
      cosmetic wound healing and scaring.
    


Intervention name(s): Standard Post Operative Skin Care; Medipore Tape
Intervention type(s): Other; Other
Intervention description(s): Control group subjects will receive the standard post-operative skin care which are steri-strips covered with gauze, and this will be removed at the first visit. No additional skin dressings will be used in the control group.; One layer of Medipore tape will be placed across the incision.
Patients will be instructed on how to change the tape, and will be encouraged to change the tape as often as once per week for hygiene.
When patients return to the office for their regularly scheduled visit, the Medipore tape will be changed and a picture of the scar will be taken.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cosmetic Wound Healing; anterior cruciate ligament (ACL)
Trial of IW-1701 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of the study are to assess the safety and tolerability of a range of single
      doses of IW-1701 when administered as oral capsules to healthy subjects, to determine the
      pharmacokinetic profile and pharmacodynamics effects of a range of single doses of IW-1701
      when administered as oral capsules to healthy subjects.
    


Intervention name(s): IW-1701; Matching Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Subjects
Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to see how ETC-1002 is tolerated in the body and how
      ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin
      therapy.
    

Detailed description: 
      Approximately 132 hypercholesterolemic patients already taking statin therapy to treat
      elevated LDL-C will be randomized in a ratio of 1:1:1 to receive either ETC-1002 (120 mg or
      180 mg dose), or placebo for 12 weeks in addition to ongoing statin therapy. This study will
      explore the safety and efficacy of ETC-1002 when given to patients receiving statin therapy.
    

Intervention name(s): ETC-1002; Placebo; Statin Therapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ETC-1002 capsules, taken once daily oral; Placebo capsules, taken once daily oral; Patients remained on ongoing statin therapy (not study provided) of either Atorvastatin 10mg or 20mg; Simvastatin 5mg, 10mg or 20mg; Rosuvastatin 5mg or 10mg; or Pravastatin 10mg, 20mg or 40mg.
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Statin; LDL; Cholesterol
Efficacy Against TB Disease, Safety, and Immunogenicity of MVA85A/AERAS-485 in HIV-Infected Adults (C-030-485)
Condition: Tuberculosis; HIV Infections
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, proof of concept, randomized, double-blind, placebo-controlled study to
      evaluate the protective efficacy against TB disease, safety, and immunogenicity of
      MVA85A/AERAS-485 in healthy, HIV-infected adults.

      This study consists of 650 adults subjects (ages 18-50 years of age inclusive) who will
      receive study vaccine or placebo at Study Day 0 and again 6-9 months later. Samples for
      real-time evaluation of immunogenicity were to be collected from 70 subjects (immunogenicity
      analysis set).
    

Detailed description: 
      This Phase II multi-country trial was conducted as a randomized, double-blind,
      placebo-controlled trial in 650 HIV-positive adults with no evidence of active TB disease.
      Subjects were stratified at the time of randomization by whether or not they were receiving
      anti-retroviral therapy (ART) and then randomized in a ratio of 1:1 to receive either
      MVA85A/AERAS-485 at 1 x 10^8 plaque forming units (pfu) or placebo (Candin). Randomization of
      each group was capped so that at least 50% of the subjects randomized were receiving ART at
      randomization. Subjects were to receive an intradermal injection of MVA85A/AERAS-485 or
      placebo on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485
      or placebo. The minimum follow-up period for each subject was 6 months after their last
      vaccination, during which subjects were followed for safety, clinical signs and symptoms of
      TB, and immunogenicity. All subjects were to continue to be followed every 3 months until the
      last subject enrolled had been followed for 6 months after their last vaccination.
    

Intervention name(s): MVA85A/AERAS-485; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485.; Subjects received an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo.
Other intervention name(s): Candida albicans Skin Test Antigen; Candin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV; Tuberculosis; Vaccine
Intra-nasal vs. Intra-venous Ketamine Administration
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The current study wishes to contribute to the applicability of the use of ketamine in a
      clinical setting by focusing on the efficacy of intra-nasal administration compared with the
      IV route.
    


Intervention name(s): Placebo; Ketamine (1st phase); Ketamine (2st phase)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Saline 0.9%, Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils); Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils); Patients failing to achieve response (<50% MADRS score) in the parallal phase, will be offered additional 4 session (twice a week, 2 weeks) of 0.5 mg/kg ketamine over 40 minutes.
Other intervention name(s): Saline 0.9%; Ketalar; Ketalar
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Brain Imaging Study
Condition: Brain Health
Study type: Interventional

Summary: 
      The study is designed to evaluate the effects of the proprietary nutritional supplement on
      cognition, mood, and brain imaging parameters following a relatively short period of
      treatment.
    


Intervention name(s): Proprietary Nutritional Supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules taken by mouth with morning and evening meals.; 2 capsules taken by mouth with morning and evening meals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)