bioihbjkbjnl/mcl2 huggingface dataset:
Prophylaxis Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this randomized, two-arm parallel clinical study in 66 previously
      treated patients with severe or moderately severe hemophilia A is to compare the rate of
      bleeding episodes for standard prophylaxis (20-40 IU/kg every 48 ± 6 hours; actual dose
      determined by the investigator) with that of alternate prophylaxis (20-80 IU/kg every 72 + 6
      hours; actual dose determined by Baxter utilizing an algorithm and the patient's
      pharmacokinetic data). The rates of bleeding episodes for the on-demand regimen and the
      prophylaxis regimens will also be compared for the cross-over portion of the study. Enrolled
      patients will be treated originally on demand for a period of 6 months and then they will be
      randomized into one of the prophylaxis arms. Prophylactic treatment will last for a period of
      12 months +/- 2 weeks.
    


Intervention name(s): Antihemophilic factor, recombinant, manufactured protein-free; Antihemophilic factor, recombinant, manufactured protein-free
Intervention type(s): Drug; Drug
Intervention description(s): Standard prophylaxis: 20-40 IU/kg every 48+/-6 hours, actual dose determined by investigator; PK-driven prophylaxis: 20-80 IU/kg every 72+/-6 hours, actual dose determined by Baxter using an algorithm and the patient´s pharmacokinetic data
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Decompressive Craniectomy in Patients With Cerebellar Infarction
Condition: Cerebellar Stroke
MeSH terms: Infarction
Study type: Interventional

Summary: 
      The investigators aimed to evaluate the outcome in participants up to 80 years of age with
      space-occupying cerebellar infarction treated with suboccipital decompressive craniectomy
      (SDC) compared to medical therapy alone.
    

Detailed description: 
      This trial is a prospective, randomized, controlled, clinical trial based on a stroke center.
      The primary end point was survival with favorable outcome, defined as a score of 0 to 3 on
      the mRS at 12 months (±30 days) after randomization (defined by a score of 0 to 3 on the
      modified Rankin scale (mRS), which ranges from 0 [no symptoms] to 6 [death]). Secondary
      outcomes included death, Barthel Index, baseline stroke severity NIHSS (National Institute of
      Health Stroke Scale), and SF-36 at 6 months and 1-year after randomization. The variables for
      subgroup analysis were age, sex, time to randomization, lesion volume, brainstem involvement,
      hemorrhagic transformation.
    

Intervention name(s): suboccipital decompressive craniectomy
Intervention type(s): Procedure
Intervention description(s): extensive bilateral suboccipital decompressive craniectomy with duraplasty
Other intervention name(s): space occupying surgey
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants assigned to either conservative medical or SDC group with a 1:1 allocation assignment using a random number table by co-decision of a neurologist, neurosurgeon and statistician
Masking: Single (Care Provider)
Primary purpose: Prevention
A Pharmacokinetic and Pharmacodynamic Study of Metformin and Canagliflozin in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the potential interaction between multiple oral
      doses of canagliflozin and a single oral dose of metformin in healthy adult volunteers.
    

Detailed description: 
      This is an open-label (volunteers will know the names of treatments they are assigned)
      single-center study of canagliflozin and metformin in healthy adult volunteers. Canagliflozin
      (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood
      sugar levels in patients with type 2 diabetes mellitus (T2DM) and metformin is an approved
      treatment for patients with T2DM. Canagliflozin will be administered orally (by mouth) as a
      single 300-mg tablet on Days 4, 5, 6, 7, and 8 and metformin will be administered orally as
      two 1,000 mg tablets on Days 1 and 8. Both canagliflozin and metformin tablets will be taken
      with 8 ounces (240 mL) of water.
    

Intervention name(s): Canagliflozin/Metformin
Intervention type(s): Drug
Intervention description(s): Two 1000-mg tablets of metformin on Day 1 followed by one 300-mg tablet of canagliflozin once daily on Days 4 through 8, followed by two 1000-mg tablets of metformin and one 300-mg tablet of canagliflozin on Day 8.
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Canagliflozin; Metformin (GLUCOPHAGE IR); Pharmacokinetics; Pharmacodynamics
A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of JNJ-42165279 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of repeated administration of 200 mg of
      itraconazole on the single-dose pharmacokinetics of JNJ-42165279 in healthy male
      participants.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), study in healthy
      male participants. This study will consist of a screening phase (between 21 and 2 days prior
      to the first dose administration of JNJ-42165279), a 2-period (Period 1: Day 1 to Day 3 and
      Period 2: Day 4 to Day 10) open-label treatment phase, and a follow-up phase (within 7 to 14
      days after the last dose of JNJ-42165279). A single 30-mg dose of JNJ-42165279 will be
      administered on Day 1 of Period 1. During Period 2, the administration of oral itraconazole
      200 mg once a day will start on Day 4. A second single oral 30-mg dose of JNJ-42165279 will
      be administered on Day 8 together with the dose of 200 mg itraconazole. Sixteen healthy
      participants will be enrolled in this study. Safety assessments will include assessment of
      adverse events, supine vital signs, 12-lead electrocardiogram, clinical laboratory testing
      and physical examinations. The maximum study duration for each participant will be
      approximately 7 weeks.
    

Intervention name(s): JNJ-42165279; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single 30-mg (6 mL of oral suspension) dose of JNJ-42165279 orally (by mouth) on Day 1 (Period 1) and on Day 8 (Period 2).; Participants will receive itraconazole 200 mg (2 capsules) once a day orally on Days 4, 5, 6, 7, 8, 9, and 10 (Period 2).
Intervention MeSH terms: Itraconazole; JNJ-42165279
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; JNJ-42165279; Itraconazole; Pharmacokinetics
Physical Activity and Cognitive Behavioural Therapy in Panic Disorder
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional

Summary: 
      Physical activity (treadmill) supports the effect of cognitive behavioural therapy in
      patients with panic disorder with/without agoraphobia
    

Detailed description: 
      Patients undergo cognitive behavioural therapy consisting of 8 group sessions within 1 month.
      All patients additionally complete a training of physical activity, which starts
      simultaneously to therapy and runs for 8 weeks (3 times/week, 30 minutes each). Half of the
      patients complete training on a treadmill while the other half completes a training programme
      of low intensity physical activity without cardiovascular activation.

      Flanking EEG (electroencephalogram) recordings shall help clarify biological processes
      underlying the therapeutical process.
    

Intervention name(s): Cognitive Behavioural Therapy (CBT)
Intervention type(s): Behavioral
Intervention description(s): 9 sessions of CBT including psychoeducation and interoceptive exposure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Panic disorder; Physical activity
Non Culprit Lesion Study
Condition: STEMI
MeSH terms: ST Elevation Myocardial Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the present study is to compare the evolution of non culprit lesions after
      treatment by BVS versus optimal medical therapy at 2-years follow- up
    

Detailed description: 
      Objectives and hypothesis: scaffolding a non culprit /vulnerable coronary plaque with BVS
      could facilitate the stabilization process into the atherosclerotic plaque with modifications
      of plaque morphology, especially the lipid content which is considered as one of the main
      factor leading to recurrent MACE after an ACS.

      The interaction between the polymer Platform and the vessel wall, the effect of the
      everolimus on neointima growth and cellular response into the media could reduce the
      inflammatory process into the vulnerable plaque could be different Under OMT and BVS
      implantation.
    

Intervention name(s): the ABSORB:bioresorbable vascular scaffold; O.M.T
Intervention type(s): Device; Drug
Other intervention name(s): to compare to optimal medical treatment; to compare with device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early Prediction of Fluoxetine Response
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to identify what degree of symptom changes during the early
      weeks could be used to predict eventual nonresponse at week 6 among depressive inpatients
      taking fluoxetine.
    

Detailed description: 
      Patients with major depressive disorder will receive 20 mg/day of fluoxetine for six weeks.
      Symptom severity was assessed by the 17-item Hamilton Depression Rating Scale (HAMD-17) at
      weeks 0, 1, 2, 3, 4 and 6. Stable response is defined as a reduction of 50% or more of the
      HAMD-17 score at week 4 and week 6 of treatment. Receiver operating characteristic curve will
      be used to determine the cutoff point of the percentage of HAMD-17 score reduction between
      stable responders and nonresponders at weeks 1, 2, 3 and 4.
    

Intervention name(s): fluoxetine
Intervention type(s): Drug
Intervention description(s): fluoxetine 20 mg/d
Intervention MeSH terms: Fluoxetine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: major depressive disorder, fluoxetine, Hamilton Rating Scale for Depression (HAM-D-17)
Phenylbutyrate Response as a Biomarker for Alpha-synuclein Clearance From the Brain
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I clinical trial of the FDA approved drug Glycerol Phenylbutyrate to see if
      phenylbutyrate can increase the removal of alpha-synuclein from the brain into the
      bloodstream. Alpha-synuclein forms abnormal protein deposits in dopamine neurons and is
      believed to cause the death of brain cells, leading to Parkinson's Disease.
    

Detailed description: 
      This is a Phase I clinical trial of phenylbutyrate in 20 Parkinson patients and 20 age- and
      sex-matched normal control subjects to see if phenylbutyrate can increase the removal of
      alpha-synuclein from the brain into the bloodstream. All subjects will receive 20 grams/day
      of phenylbutyrate in the liquid form phenylbutyrate-triglyceride taken as one teaspoonful
      three times per day with meals. Blood will be drawn on two days prior to starting
      phenylbutyrate to measure alpha-synuclein concentrations. Phenylbutyrate-triglyceride will
      then be started and the change in plasma alpha-synuclein will be measured on day 1, 7, 14,
      and 21 days while taking phenylbutyrate. After 21 days, the drug will be stopped and a final
      blood sample will be measured at 28 days to see if plasma alpha-synuclein has fallen to its
      pre-phenylbutyrate level. No effects on Parkinson symptoms are expected during this short
      trial. Please note that although taking any type of Parkinson's drugs for symptomatic
      treatment disqualifies you, if you and your neurologist are willing and able to have you off
      Parkinson medication for six weeks before and during the trial, you may be eligible to
      participate.
    

Intervention name(s): Glycerol Phenylbutyrate
Intervention type(s): Drug
Other intervention name(s): Ravicti
Intervention MeSH terms: 4-phenylbutyric acid; Glycerol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety of INCB054707 in men and women with
      moderate to severe hidradenitis suppurativa (HS).
    


Intervention name(s): INCB054707
Intervention type(s): Drug
Intervention description(s): INCB054707 administered once daily orally with water without regard to food for 8 weeks.
Other intervention name(s): Povorcitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hidradenitis suppurativa (HS); Janus kinase (JAK); Janus kinase 1 (JAK1) inhibitor
Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study)
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine the role of CLA as a complementary therapy to
      improve body composition, glucose tolerance, fasting plasma glucose and insulin, and
      hemoglobinA1c (HbA1c) in subjects with type 2 diabetes mellitus (T2DM).
    

Detailed description: 
      The design is a double-blind, placebo-controlled, crossover study conducted at a single site.
      The primary variable is a change from baseline to Week 16 in plasma glucose area under the
      curve during a three-hour oral glucose tolerance test. Secondary variables include changes in
      fasting levels of glucose and insulin, glucose tolerance, hemoglobinA1c, hepatic enzymes,
      adipocytokines, blood lipid profile, and body composition. Supporting endpoints include
      dietary intake, physical activity, fatty acids, and vital signs.
    

Intervention name(s): Conjugated Linoleic Acid (CLA); Safflower OIl
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 6.4 g CLA/day, capsule form, for 16 week arms; 8.0g/day safflower oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; conjugated linoleic acid
Indomethacin and Mechanisms Underlying Risk of Falling
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether indometacin has an effect on reaction time,
      postural stability, and the avoidance of obstacles.
    

Detailed description: 
      A lot of (epidemiologic) research is done on causes for falls and factors contributing to
      falling. Most of this research was conducted on the elderly, either community-dwelling or
      institutionalised. It became clear that the elderly have a greater risk at falling because
      of:

        -  physiological changes due to increasing age [Gerdhem et al., 2005]

        -  previous falls [Myers et al., 1991; Lipsitz et al., 1992]

        -  comorbidity (including RA) [Bergland et al., 2004; Gerdhem et al., 2005; Lawlor et al.,
           2003]

        -  polypharmacy [Lawlor et al., 2003; Walker et al., 2005; Ziere et al., 2005] and/or

        -  use of specific drugs like antidepressives, benzodiazepines, vasodilators, and NSAIDs
           [Cumming R, 1998; Herings RMC, 2001; Kallin K et al., 2004; Granek et al., 1987].

      The relation between benzodiazepines and falling has been extensively investigated in and
      affirmed by several fields of research and is practically common sense. However, the
      (possible) relation between NSAIDs and falling is much less investigated, even though there
      are various articles in which a higher risk of falling when using NSAIDs is stated; sometimes
      the risk is even as high as with benzodiazepines [Cumming R, 1998; Granek et al., 1987;
      Walker et al., 2005].

      Objective of the study:

      NSAIDs are drugs that are often prescribed to patients with rheumatic or orthopedic diseases.
      They seem to be at a greater risk for falls than healthy persons because of their disease,
      age and medication use. Therefore it is very important to keep this risk as small as
      possible. In this study healthy adults are measured on reaction time, postural balance and
      obstacle avoidance with and without use of indometacin or placebo. This is done in order to
      gain more comprehension in the mechanism and actual risk for falls when using NSAIDs.
    

Intervention name(s): Indometacin
Intervention type(s): Drug
Intervention MeSH terms: Indomethacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: indometacin; reaction time; postural balance; obstacle avoidance; accidental falls
HIV Sequencing After Treatment Interruption to Identify the Clinically Relevant Anatomical Reservoir
Condition: HIV
Study type: Interventional

Summary: 
      The main goal of this study is to identify and characterise the anatomical component of the
      replication competent HIV-1 (Human Immunodeficiency Virus-1) reservoir.

      The investigators hypothesize that the clinically relevant HIV-1 reservoir is hiding in
      various but specific anatomic compartments and is able to rebound when therapy is stopped.

      This reservoir is probably smaller than the HIV-1 reservoir hiding in the blood but could be
      more transcriptional active because of its specific environment, possibly influenced by lower
      concentrations of the antiretroviral therapy.

      The current proposal will, for the first time, identify the source of the viral reservoir by
      phylogenetically backtracking the viral genome of the rebounding virus to the sequences of
      viral DNA (DeoxyriboNucleic Acid) in different anatomical compartments. The subsequent
      characterization of the viral reservoir markers (size, integration sites, methylation
      profile, stimulation and inhibition assays) will enable us to understand how this viral
      rebound occurred.
    


Intervention name(s): treatment interruption after in depth sampling under CART
Intervention type(s): Other
Intervention description(s): The participants will undergo in depth sampling under CART to characterise the HIV reservoir in different anatomical compartments. Subsequently an experimental viral rebound, by a brief therapy stop, will help us identify the clinically relevant viral reservoir by doing phylogenetic analysis on the rebounding virus and on the virus found in the different compartments under CART.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: HIV reservoir; phylogenetic analysis; sequencing
Hemodynamic and Ventilatory Responses to Head-down Postural Drainage Position
Condition: Traumatic Blunt Chest and/or Blunt Abdominal Injury
MeSH terms: Abdominal Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to explore acute hemodynamic and ventilatory responses to
      head-down 30 degree postural drainage position in patients with blunt chest and/or abdominal
      injury in the traumatic intensive care unit.
    

Detailed description: 
      Study Protocol The study protocol consisted of 2 conditions: treatment condition (A) and sham
      condition (B). The order of the conditions was randomly assigned to either the treatment or
      sham for the first round and vise versa in the second round in a balanced cross-over design
      (A-B-B-A) so there were four sets of measurements per patient.

      For the treatment condition (A), the study consists of three consecutive periods 1) baseline
      period: 10 minutes rest in horizontal supine lying 2) intervention period: 10 minutes rest in
      head-down 30 degree supine lying 3) recovery period: return to horizontal supine lying and
      rest for 10 minutes . For the Sham condition (B), the study was performed with a similar
      procedure except the intervention period consisted of horizontal supine lying.

      Hemodynamic and ventilatory parameter were recorded at the start of each period (0 min) and
      every 2 minute until end of each period for both conditions. Hemodynamic and ventilatory
      dependent variables were heart rate (HR), systolic blood pressure (SBP), diastolic blood
      pressure (DBP), mean arterial pressure (MAP), electrocardiography (ECG), central venous
      pressure (CVP), respiratory rate (RR), oxygen saturation (SpO2), tidal volume (VT), minute
      ventilation (VE), dynamic lung compliance (Cdyn) and end-tidal expiratory pressure of CO2
      (PETCO2). Subjects were rested between each condition. Subjects were suctioned via
      endotracheal tube to clear airway at 10 minutes before study commencement of either A-B or
      B-A.
    

Intervention name(s): Head down 30 degree postural drainage position; Horizontal supine lying
Intervention type(s): Other; Other
Intervention description(s): supine head down 30 degree on tilt table (intervention period in the treatment condition); horizontal supine lying on tilt table (intervention period in the sham condition)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: head down postural drainage
Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      To use different starting doses of methotrexate (7.5 mg per week) versus 15 mg per week in
      patients with rheumatoid arthritis, followed by similar hiking up of dose (2.5 mg per 2
      weeks, till max of 25 mg per week). To look at the effect on efficacy ( or speed of efficacy)
      versus the adverse effects.

      Hypothesis: There will be no difference in the adverse effects, but better and faster control
      of disease when starting with a higher methotrexate dose
    


Intervention name(s): Methotrexate
Intervention type(s): Drug
Intervention description(s): Different doses for both arms followed by similar escalation (2.5 mg every 15 d) till max of 25 mg per week or 3 months completed
Other intervention name(s): MEXATE
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; Active