bioihbjkbjnl/mcl2 huggingface dataset:
Comparing Tai Chi Chih and Relaxation Therapy in the Treatment of Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to compare the effectiveness of relaxation therapy and tai chi
      in treating the symptoms of rheumatoid arthritis (RA).
    

Detailed description: 
      RA is a debilitating disease characterized by inflammation of the joints, leading to chronic
      pain, loss of function, and disability. Complementary and alternative medicine (CAM)
      treatments are being used with increased frequency by patients with chronic pain and
      rheumatic diseases to relieve their symptoms. While patients find these treatments helpful,
      there is limited scientific evidence of the effectiveness of these interventions. This study
      will compare relaxation therapy (a commonly used treatment for RA) to tai chi chih (a
      combination of slow, deliberate movements and meditation) in treating the symptoms of RA.

      Participants will be randomly assigned to receive 12 weeks of either relaxation therapy or
      tai chi chih. At study entry and Weeks 6 and 12, participants will complete questionnaires
      about their RA symptoms, health functioning, overall quality of life, and complete a brief
      medical exam.
    

Intervention name(s): Tai Chi Chih; Relaxation training
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Arthritis; Tai Chi; Meditation; Relaxation Techniques
A Study To Determine Bioequivalence Between The Commercial Femulen Tablets And A Reformulation Of Femulen Tablets In Healthy Female Subjects
Condition: Therapeutic Equivalency
Study type: Interventional
Phase: Phase 1

Summary: 
      A pivotal study to determine bioequivalence between a the current marketed formulation of
      Femulen tablets and reformulated Femulen tablets in healthy female subjects.
    


Intervention name(s): etynodiol diacetate; etynodiol diacetate
Intervention type(s): Drug; Drug
Intervention description(s): tablet, 0.5 mg, single dose; tablet, 0.5 mg, single dose
Intervention MeSH terms: Ethynodiol Diacetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioequivalence study; marketed vs reformulation tablets; Femulen
Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fed Condition
Condition: Fed
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,
      balanced, single dose pivotal study. The purpose of this study is to assess the
      bioequivalence between Test Product and the corresponding Reference Product under fed
      condition in healthy adult human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Lamotrigine Tablets 25 mg (2 x 25 mg)of M/s Ipca Laboratories Limited, India and the
      corresponding Reference Product: LAMICTAL® (Lamotrigine) Tablets 25 mg (2 x 25 mg) of
      GlaxoSmithkline, USA, under fed condition in healthy adult human subjects in a randomized
      crossover study.

      The study was conducted with 28 healthy adult subjects. In each study period, a single 2 X 25
      mg dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 26 days including washout period of at
      least 21 days between administrations of study drug in each study period.
    

Intervention name(s): Lamotrigine Tablets 25 mg; Lamotrigine
Intervention type(s): Drug; Drug
Intervention description(s): 2 x 25 mg tablet once a day; 2 x 25 mg tablet once a day
Other intervention name(s): Test Product; LAMICTAL®
Intervention MeSH terms: Lamotrigine; Anticonvulsants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bevacizumab and Endothelium Dependent Vasodilation
Condition: Hypertension; Cancer; Endothelial Dysfunction
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The introduction of angiogenesis inhibitors has remarkably improved treatment of patients
      with several types of cancer. One of the most reported side effects of angiogenesis
      inhibitors is hypertension. In patients treated with bevacizumab, a monoclonal antibody
      against vascular endothelial growth factor, hypertension had an overall incidence up to 32%.
      The increase in blood pressure occurs early in treatment. The etiology of hypertension caused
      by treatment with angiogenesis inhibitors is unclear. Understanding the pathogenesis of this
      side effect is essential for optimal treatment with this class of drugs.

      The primary objective is to explore the effect of bevacizumab infusion on
      endothelium-dependent vasodilation of forearm resistance arteries.
    


Intervention name(s): Acetylcholine; Nitroprusside; Bevacizumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intra-arterial infusion; Intra arterial infusion; Intra arterial infusion
Intervention MeSH terms: Bevacizumab; Nitroprusside; Acetylcholine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 12-week, open-label, dose-escalation Phase 1b study of a herbal treatment given
      orally to subjects with ulcerative colitis. Subjects will be sequentially enrolled to one of
      two cohorts in up to two clinical sites. Treatment will be given for 8 weeks and study
      duration will be 12 weeks.
    

Detailed description: 
      This study consists of a 3-month period (12 weeks). You will receive study drug (SA100) for a
      2-month period (8weeks) and then will continue to receive study assessements for an
      additional 1 month (4weeks). During the period in which you receive study drug (SA100), you
      will be asked to take the study drug twice a day (once in the morning and once in the
      evening), preferably at the same time each day. You will be assigned to one of three possible
      treatment groups. The three possible treatment groups are SA100 250 mg, 500 mg, or 750 mg.
      The group you are assigned to at the start of the study will remain the same throughout the
      study.

      Blood samples, stool (feces), and tissue biopsies (up to 3 per region of colon) will be
      collected for testing purposes. These samples may also be kept for several years for future
      research.

      An electrocardigram (ECG, which measures the electrical activity in your heart) will be taken
      at screening and week 2; and a flexible sigmoidoscopy will be performed at screening and week
      8, (flexible tube that visualizes your intestine/colon and allows for tissue and stool to be
      obtained) to confirm your diagnosis of ulcerative colitis, to assess the severity of your
      disease, and for future testing of your tissue.
    

Intervention name(s): Herbal treatment (SA100)
Intervention type(s): Drug
Intervention description(s): This treatment has been used extensively in traditional medicine practices for hundreds of years.
Other intervention name(s): SA100
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas
Condition: Perianal Fistulas
MeSH terms: Rectal Fistula; Fistula
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the effects of rectally administered activated carbon
      (medical device KULIST) in chronic, uncomplicated, perianal fistulas.
    

Detailed description: 
      Patients with chronic uncomplicated perianal fistulas located below levator ani will be
      treated twice daily with KULIST for 8 weeks. The efficacy will be evaluated by means of an
      overall clinical evaluation of fistula closure, as well as by anal ultrasonography.

      Also changes in Patient Assessment of Symptoms and Impact on Daily Function will be
      evaluated. Safety will be evaluated by standard adverse event /adverse device effects
      reporting.
    

Intervention name(s): KULIST
Intervention type(s): Device
Intervention description(s): Twice daily dosing for 8 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Supraclavicular Versus Interscalene Block for Shoulder Surgery
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to compare the supraclavicular block to interscalene block in
      patients undergoing arthroscopic shoulder surgery.
    

Detailed description: 
      The aim of this study is to evaluate the efficacy of the supraclavicular block in comparison
      with interscalene block on postoperative pain, quality of recovery and side effects in
      patients undergoing arthroscopic shoulder surgery under general anesthesia.
    

Intervention name(s): Supraclavicular Block; Interscalene Block; Bupivacaine; Ultrasound
Intervention type(s): Procedure; Procedure; Drug; Device
Intervention description(s): Under ultrasound guidance an insulated needle is advanced with in- plane technique into the brachial plexus sheath and 20ml 0.25% bupivacaine will be administered; Under ultrasound guidance an insulated needle will be placed through the middle scalene muscle,into the interscalene groove with in-plane technique and 20ml 0.25%bupivacaine will be administered into the brachial plexus; 20ml 0.25% bupivacaine will be injected for brachial plexus block; The Ultrasound will be used for brachial plexus visualization
Other intervention name(s): Marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Anesthesia Recovery Period; Brachial Plexus
Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic Granulocyte Macrophage Colony-stimulating Factor (GM-CSF)-Based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Patient Population: Patients with active myeloma (Stage II/III) that have completed induction
      therapy and are eligible for an autologous stem cell transplant.

      Number of Patients: Will treat a total of 32 evaluable patients in a 1:1 randomization of
      aMILs vs aMILs plus vaccine. An evaluable patient is defined as one which has received the
      activated MILs and is at least 6 months post-transplant.

      Study Objectives:

      Disease response as determined by the Blade' criteria will be the primary endpoint of the
      trial at one year.

      Additional study endpoints include progression free survival, parameters of T cell
      reconstitution, anti-tumor immune responses as well as the effect on osteoclastogenesis and
      clonogenic myeloma precursor cells.
    


Intervention name(s): Activated marrow infiltrating lymphocytes; Allogeneic Myeloma Vaccine; Cyclophosphamide; Filgrastim; Leukapheresis; Melphalan; Autologous stem cell transplant
Intervention type(s): Biological; Biological; Drug; Biological; Procedure; Drug; Biological
Intervention description(s): Administered on Days 3 and 4.; Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.; Administered at 2.5 g/m^2.; Administered post cyclophosphamide daily until leukapheresis.; Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.; 100 mg/m^2/day given on Days -2 and -1.; Infused on Day 0.
Other intervention name(s): MILs; aMILs; Cytoxan; G-CSF; Apheresis; Alkeran; ASCT
Intervention MeSH terms: Cyclophosphamide; Melphalan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple myeloma
Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with
      the addition of Avastin as 1st line treatment of colorectal cancer.
    

Detailed description: 
      There is no data of comparison for Folfiri and Xeliri regimens. The reported data
      demonstrated that the addition of Avastin in the combination of irinotecan/bolus 5-FU/LV has
      significant improvement of overall survival. Further analysis of these results showed that
      patients receiving irinotecan in combination with Avastin, as 1st line treatment and
      oxaliplatin with Avastin, as second line treatment, have median overall survival 25, 1
      months, which is the longest survival that has been reported.
    

Intervention name(s): Irinotecan; 5-Fluorouracil; Leucovorin; Capecitabine; Bevacizumab; Bevacizumab; Irinotecan
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Irinotecan 150mg/m2 IV on day 1 every 2 weeks for 10 cycles; 5-Fluorouracil 400 mg/m2 infused over 10 min IV and 5-FU 600 mg/m2 infused over 22 hours IV, on Day 1 and 2 (De Grammont regimen), every 2 weeks for 10 cycles; Leucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles; Capecitabine 2000mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles; Bevacizumab 5mg/kg IV on day 1 every 2 weeks for 10 cycles; Bevacizumab 7,5mg/kg IV on day 1 every 3 weeks for 6 cycles; Irinotecan 250mg/m2 IV on day 1 every 3 weeks for 6 cycles
Other intervention name(s): CPT-11; 5-FU; LV; Xeloda; Avastin; Avastin; CPT-11
Intervention MeSH terms: Leucovorin; Bevacizumab; Capecitabine; Fluorouracil; Irinotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic colorectal cancer; Irinotecan; Capecitabine; Bevacizumab
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
Condition: Narcolepsy
MeSH terms: Narcolepsy; Sleepiness
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the pharmacokinetics, pharmacodynamics, and safety of single and
      multiple doses of armodafinil (50, 100, and 150 mg/day) in children and adolescents with
      excessive sleepiness associated with narcolepsy.
    


Intervention name(s): Armodafinil
Intervention type(s): Drug
Intervention description(s): The armodafinil tablets to be used in this study contain 50 mg of armodafinil and the following inactive ingredients: lactose monohydrate, starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and povidone.
Other intervention name(s): R-modafinil; CEP-10953
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric Narcolepsy
Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Blood Triglyceride
Condition: Hyperlipidemias
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional

Summary: 
      This study was conducted to investigate the effects of daily supplementation of Angelica
      gigas N. extract on improvement of Blood Triglyceride.
    

Detailed description: 
      This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty
      subjects were randomly divided into Angelica gigas N. extract or a placebo group. Fasting
      triglyceride profiles before and after the intervention.
    

Intervention name(s): Angelica gigas N. extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): capsules (2cap/d, 1,000mg/d) for 12 weeks.; Placebo for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Angelica gigas N. extract; Hyperlipidemia; Clinical Trial
Semi-replicate Crossover Bioequivalence Study of Dirithromycin of (Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey) in Healthy Subjects Under Fasting Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of the investigational TEST product
      with the marketed REFERENCE products by measurement of Plasma concentrations of
      Erythromycylamine and calculation of the bioequivalence parameters from those measurements
      followed by ANOVA and 90% confidence interval statistical evaluation.
    

Detailed description: 
      An open-label, randomized, three -period, two-treatment, three -sequence, semi-replicate
      crossover bioequivalence study with a washout period of at least 14 days between doses.
      Healthy, mixed skin Arab & Mediterranean Subjects ages between 18 and 50 years, body-mass
      index 18.5 to 30.0 kg/m2 inclusive (minimum of 50 kg weight), non-smokers or light smokers
      (smokers of not more than 10 cigarettes per day).
    

Intervention name(s): DIRITHROMYCIN 500 MG ENTERIC COATED TABLET; DYNABAC 250 MG ENTERIC COATED TABLET
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dirithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fasting conditions
Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity
      of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.
    

Detailed description: 
      The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil
    

Intervention name(s): pandemic vaccine 1; pandemic vaccine 2; pandemic vaccine 5; pandemic vaccine 6; pandemic vaccine 9; pandemic vaccine 10; pandmeic vaccine 11; pandmeic vaccine 12; pandmic vaccine 13; placebo group 14
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3; 3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3; 7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion; 3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion; 7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion; 3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion; 7,5µg of A/H1N1 with Al(OH)3; 3,75µg of A/H1N1 with Al(OH)3; 15µg of A/H1N1 with no adjuvant; All elements of the vaccine but antigen and adjuvant
Other intervention name(s): vaccine group C; vaccine group I; vaccine group N; vaccine group A; vaccine group F; vaccine group L; vaccine group E; vaccine group K; vaccine group H; vaccine group B
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vaccine; pandemic influenza A; adjuvant; safety
Influence of Caffeinated and Non-caffeinated Pre-workout Supplements on Resistance Exercise Performance
Condition: Resistance Training; Caffeine; Dietary Supplements
Study type: Interventional

Summary: 
      This study is a randomized, double-blind, placebo-controlled crossover trial examining the
      effects of caffeinated and non-caffeinated pre-workout supplements on resistance exercise
      performance. Resistance-trained adults will be randomly assigned to complete three study
      conditions (caffeinated pre-workout, non-caffeinated pre-workout, and placebo) in one of the
      six possible condition orders. During each condition, participants will report to the
      laboratory for ingestion of the assigned beverage and subsequent muscular performance
      testing. Major performance outcomes will be force production variables from a mechanized
      squat device and maximal strength and muscular endurance on the bench press and leg press
      exercises.
    


Intervention name(s): Caffeinated pre-workout supplement; Non-caffeinated pre-workout supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The intervention will consist of consuming a standardized meal followed by one serving of the commercially available Pulse caffeinated pre-workout supplement (Legion Athletics, Inc.).; The intervention will consist of consuming a standardized meal followed by one serving of the commercially available Pulse non-caffeinated pre-workout supplement (Legion Athletics, Inc.).; The intervention will consist of consuming a standardized meal followed by a placebo beverage.
Other intervention name(s): Legion Athletics Pulse Pre-workout Supplement; Legion Athletics Pulse Pre-workout Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a randomized, double-blind, placebo-controlled crossover trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: caffeine; resistance training; resistance exercise; pre-workout supplement; dietary supplements
Control Study of Nautilus BrainPulse for the Detection of Concussion
Condition: Brain Concussion
MeSH terms: Brain Concussion
Study type: Observational

Summary: 
      To use the Nautilus BrainPulse to compare and contrast the signal patterns from this cohort's
      signal patterns with those of concussed high school athletes.
    

Detailed description: 
      This study is a non-blinded study in high school athletes who will be presumed to no be
      suffering from a concussion. Healthy controls will be recruited from high school sports that
      are not associated with physical contact, which could generate concussions.

      The primary objective of this study is to improve Jan Medical's signal analysis. Jan Medical
      will perform analysis.
    

Intervention name(s): Nautilus BrainPulse
Intervention type(s): Device
Intervention description(s): A noninvasive device to detect concussion utilizing headset and sensors
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who are healthy controls and participate in a non-contact sport at the high school
        level.