bioihbjkbjnl/mcl2 huggingface dataset:
Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Study assessing cognitive function and physical activity in people with relapsing remitting
      multiple sclerosis.
    


Intervention name(s): Interferon beta-1b (Betaseron, BAY86-5046)
Intervention type(s): Drug
Intervention description(s): Patients treated with regular dose subcutaneously administered, according to the label and to clinical routine practice.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community Sample
      
Keywords: Cognition; Physical Activity; Relapsing Remitting Multiple Sclerosis
Pharmacokinetic Interaction Between Ibuprofen and Acetaminophen Oral Suspension
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was carried out in the Clinical and Analytical Unit of the Pharmacology and
      Toxicology Department of the Faculty of Medicine of the Autonomous University of Nuevo León,
      in order to compare the bioavailability (Cmax, AUC) of an oral formulation containing
      Ibuprofen 100 mg/Acetaminophen 125 mg in combination with the two oral formulations Ibuprofen
      100 mg or Acetaminophen 125 mg administered as a single dose, in healthy subjects under
      fasting conditions.
    

Detailed description: 
      The study design was crossover, 3 x 6 x 3, open, prospective and longitudinal, at a single
      dose, of the combination of Ibuprofen 100 mg/Acetaminophen 125 mg/5 mL suspension,
      administered orally versus each component administered individually Ibuprofen 100 mg/5 mL or
      Acetaminophen 125 mg/3.9 mL, with an elimitation period (washout) of 1 week. In order to
      compare the pharmacokinetic profile (Cmax and AUC0-t) of the Ibuprofen/Acetaminophen
      combination 100 mg/125 mg/5 mL, versus each component administered individually, in 42
      healthy subjects, of both genders, under fasting conditions, to establish the interaction of
      drugs in combination. As well as, to characterize the pharmacokinetic parameters, Cmax and
      AUC0-t, AUC0-∞, Tmax, Ke, and T1/2 and to establish the frequency and type of adverse events
      with the two formulations.
    

Intervention name(s): A1: Ibuprofen/Acetaminophen Fixed dose combination oral suspension (Laboratorios Silanes S.A. de C.V.); A2: Ibuprofen (Advil®, Pfizer S.A. de C.V.); A3: Acetaminophen (Tylenol®, from Janssen-Cilag, S.A. de C.V.)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Formula : 100 mg/ 125 mg /5mL Pharmaceutical Form: Oral suspension Dosage: 5mL (100 mg/125mg) Administration way: oral; Pharmaceutical Form: oral suspension Formula: 2 g/100 mL Dosage: 5 mL(100 mg of Ibuprofen) Administration way: oral; Pharmaceutical Form: oral suspension Formula: 3.2 g/100 mL Dosage: 3.9 mL (125 mg) Administration way: oral
Other intervention name(s): IBU/ACETA SUSP; IBU SUSP; ACETA SUSP
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic; Bioavailability; Fixed-dose combination (FDC); Ibuprofen; Acetaminophen; Oral suspension; Pain
tDCS on Precuneus in MCS: Repeated Stimulations
Condition: Patients in Minimally Conscious State After a Severe Brain Injury
MeSH terms: Brain Injuries; Persistent Vegetative State
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study researchers will apply transcranial direct current stimulation (tDCS) for 5
      consecutive days in chronic patients in minimally conscious state (MCS).
    

Detailed description: 
      Positive effects of tDCS in patients in MCS was showed in a recent study published in
      Neurology. But the effects went down after 1 or 2 hours. To increase the lasting of the
      effects, a new study will evaluate the effects of tDCS on the precuneus cortex for 5
      consecutive days in chronic patients in MCS.

      2 sessions of 5 days of stimulation will be realized, one session will be real (anodal
      stimulation) and one placebo (sham stimulation). After each stimulation, behavioral
      improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment
      will be done 5 days after the end of the sessions to assess the long term effect of the tDCS.

      Researchers expected to see an improvement of the CRS-R total score at the end of the anodal
      session and that this improvement persists for 5 days.
    

Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): anodal transcranial direct current stimulation on the precuneus cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: disorders of consciousness; minimally conscious state; traumatic brain injury; stroke; transcranial direct current stimulation
Trial of MR-guided Focused Ultrasound for Treatment of Refractory Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The proposed study is to evaluate the safety and initial efficacy of MRgFUS for patients with
      treatment-refractory Major Depression. This study is designed as a prospective, single arm,
      nonrandomized study. Assessments will be made before and after MRgFUS for adverse events
      related to treatment, for clinical symptom relief, and quality of life (QoL). The target in
      the brain chosen for ablation will be the anterior limb of the internal capsule (i.e
      'capsulotomy').
    


Intervention name(s): MR-guided Focused Ultrasound
Intervention type(s): Device
Intervention description(s): Focused Ultrasound allows for non-invasive thermal ablation of soft tissue virtually anywhere in the body. Treatment begins by acquiring a series of magnetic resonance (MR) images of the target tissue. The physician then reviews the images on the system workstation, identifies the target, delineates treatment contours, and reviews the treatment plan. Therapy planning software calculates the parameters required to effectively treat (e.g. ablate) the defined region. During treatment, the patient wears a helmet equipped with multiple sources of ultrasound which generate a point of focused energy, called a sonication. The sonication raises the tissue temperature within a well-defined region, causing a thermal coagulation effect.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Palbociclib + Ganitumab In Ewing Sarcoma
Condition: Ewing Sarcoma; Ewing's Sarcoma Recurrent
MeSH terms: Sarcoma; Sarcoma, Ewing
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study is designed to study the combination of two drugs, palbociclib and
      ganitumab, as a potential treatment for Ewing sarcoma.

      The names of the study drugs involved in this study are:

        -  Palbociclib

        -  Ganitumab
    

Detailed description: 
      This research study involves participants taking a medicine that inhibits proteins in cancer
      cells called CDK4 and CDK6 (palbociclib) in combination with a medicine that inhibits a
      protein called IGF-1R (ganitumab). This study is designed to see if these drugs are safe when
      given together and whether they are effective in treating Ewing sarcoma.

      This research study is a Phase II clinical trial. Phase II clinical trials test the safety
      and effectiveness of an investigational drug or drug combination to learn whether the drug(s)
      works in treating a specific disease. "Investigational" means that the drug or combination is
      being studied.

      The U.S. Food and Drug Administration (FDA) has not approved ganitumab as a treatment for any
      disease.

      The U.S. Food and Drug Administration (FDA) has not approved palbociclib for this specific
      disease but it has been approved for another cancer.

      This research study is:

        -  Testing whether palbociclib and ganitumab are safe when given together and effective in
           treating Ewing sarcoma.

        -  Testing markers in the blood and in tumor tissue to see if there are certain features of
           the tumor that may indicate this combination of drugs is effective or not effective
    

Intervention name(s): Palbociclib; Ganitumab
Intervention type(s): Drug; Drug
Intervention description(s): Oral, per protocol pre determined dosage, once a day for 21 days; -Intravenous, per protocol predetermined dosage, twice per cycle
Other intervention name(s): Ibrance®; AMG-479
Intervention MeSH terms: Palbociclib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsed or refractory Ewing sarcoma; Solid Tumor, Childhood; Sarcoma; Ewing sarcoma
Influence of Core Muscles Activation Using Physical Fitness on the Performance of Chest Compression
Condition: Heart Arrest
MeSH terms: Heart Arrest
Study type: Interventional

Summary: 
      Chest compression, a key component of cardiopulmonary resuscitation (CPR), has a major role
      for survival of cardiac arrest patients. According to 2015 American heart association (AHA)
      guideline, rescuers provide high quality CPR to adult cardiac arrest patients including 5 to
      6 cm depth and 100 to 120 beat per minute rate chest compression.

      However, in CPR situation, chest compression depth and rate vary according to provider's
      muscle strength. In other words, the individual difference of the degree of physical activity
      will make the different result for CPR. So, the investigators hypothesize that the core
      muscles activation using physical fitness improves the quality of chest compression and the
      quality of CPR, eventually.
    


Intervention name(s): core muscle activation using physical fitness
Intervention type(s): Other
Intervention description(s): 2 instructors, they had physical therapy (PT) certificate, take an exam for subject's muscle strength of each muscle. After that time, subjects take a rest for 10 minutes. Researchers educate to subjects for high quality CPR including 5 to 6cm compression depth, 100 to 120 beat per minute (bpm) rate, complete chest recoil. Subjects perform chest compression to manikin with skill reporting system during 4min under guidance of 110 bpm metronome sound (first chest compression). After 1st chest compression, subjects take a rest during an hour and carry out PT. PT consist of 30 second plank for 3 sets, 12 times bridge for 3 sets and 20 times leg extension for 3 sets. Subjects take a rest during 30 seconds between sets, 1 minute every 3 sets.
After PT completion, subjects take a rest during 10 minutes, and then perform 2nd chest compression in the same way of 1st chest compression. Researchers record subject's chest compression depth and rate in 1st and 2nd chest compression.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiopulmonary resuscitation; manikins; physical fitness
Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer for Prazosin Hydrochloride Capsules
Condition: Hypertension; Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      Prazosin hydrochloride (HCl) is an oral anti-hypertensive indicated for the treatment of
      primary and secondary hypertension and heart failure. Pfizer Inc. is the marketing
      authorization holder for prazosin HCl oral capsules and intended to transfer drug product
      manufacturing operations from Pfizer, Barceloneta Puerto Rico to Pfizer Pharmaceutical,
      Ascoli, Italy. To support the manufacturer site transfer and process changes, this
      bioequivalence (BE) study is being conducted.

      This study will be a 2 Cohort, open-label, randomized, single dose study in healthy adult
      male and/or female participants. Cohort 1 will be crossover with 3 treatments, 3 periods, 6
      sequences. Cohort 2 will be crossover with 2 treatments, 2 periods, 2 sequences. Primary
      objective of this study is demonstrate bioequivalence between prazosin HCl 1, 2 and 5 mg
      capsules manufactured at Ascoli versus prazosin HCl 2 and 5 mg capsules manufactured at
      Barceloneta under fasting conditions in healthy adult participants. Approximately 36
      participants will be enrolled in each Cohort 1 and Cohort 2.

      Pharmacokinetic and statistical analysis will be performed for prazosin. Data from 2 Cohorts
      will be analyzed separately. The PK parameters area under the plasma concentration-time curve
      from time zero to the time of the last quantifiable concentration (AUClast), and from time
      zero extrapolated to infinite time (AUCinf), maximum plasma concentration (Cmax), time to
      first occurrence of Cmax (Tmax), and terminal phase elimination half-life (t½) will be
      summarized descriptively by analyte and treatment.

      For primary objective, bioequivalence of the Test treatment relative to Reference treatment
      will be concluded if the 90% confidence intervals (CI) for the ratio of adjusted geometric
      means of Test treatments relative to Reference treatment for AUCinf (if data permit), AUClast
      and Cmax, fall wholly within (80%, 125%).
    


Intervention name(s): Prazosin HCl 2mg; Prazosin HCl 1 mg; Prazosin HCl 5 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Prazosin HCL 1 X 2 mg capsule.; Prazosin HCl 2 X 1 mg capsule.; Prazosin HCL 1 X 5 mg capsule.
Other intervention name(s): Minipress 2 mg capsule.; Minipress 1 mg capsule.; Minipress 5 mg capsule.
Intervention MeSH terms: Prazosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Both ritonavir (RTV) and indinavir (IDV) are approved by the FDA to treat HIV, but IDV has
      not been approved for use in children and the doses for the combination of the two drugs has
      not been studied in children. The purpose of this study is to find a combination of RTV and
      IDV that is safe, well tolerated, and produces drug levels in the blood of children that are
      comparable to effective drug levels in the blood of adults. The effectiveness of the drug
      combination in decreasing the amount of virus in the body will also be studied. The children
      enrolled in this study will have high HIV viral loads despite taking anti-HIV drugs.
    

Detailed description: 
      Combination regimens of RTV and IDV in adults offer the benefit of two potent antiretroviral
      agents, convenience of twice-daily dosing, unrestricted timing of meals, and fewer renal
      complications. There are limited, largely anecdotal data from children suggesting that
      initial virologic response can also be attained in children given IDV with RTV, but there are
      not sufficient pharmacokinetic data to define appropriate dose regimens. This study will
      evaluate the clinical feasibility of a combination RTV and IDV regimen for children.

      Patients will be stratified on the basis of age/Tanner stage and ability to swallow intact
      capsules. Patients will be randomized to either Balanced Dose or Low Dose RTV treatment arms.
      Patients in the Balanced Dose Arm will receive RTV and IDV in approximately equal doses. The
      Low Dose RTV Arm will receive a dosing ratio of RTV:IDV of approximately 1:3. Patients will
      have scheduled study visits every 4 weeks for 6 months, then every 3 months for approximately
      18 months. Study visits will consist of a medical history, physical exam, and blood and urine
      tests. Patients will have intensive pharmacokinetic analysis at Week 4 (or 2 weeks after a
      stable dose of study drugs has been reached) and Week 16. Study visits that include
      pharmacokinetic analysis will last 9 to 13 hours.

      At each study visit, patients will be closely assessed for drug toxicity and virologic
      response. At the end of the study, patients with good virologic response and no evidence of
      toxicity may choose to enter a 48 week extension phase and continue taking the combination
      regimen.
    

Intervention name(s): indinavir sulfate; ritonavir
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ritonavir; Indinavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dose-Response Relationship, Drug; Drug Therapy, Combination; HIV Protease Inhibitors; Ritonavir; Indinavir; Anti-HIV Agents; Viral Load; Pharmacokinetics; Treatment Experienced
Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This is an 8 week study for patients who are currently taking antidepressant medication but
      not fully responding. Ropinirole CR would be taken in conjunction with current antidepressant
      medication. Patients come into the clinic once a week when starting on the medication and
      then once every other week for the remainder of the 8 weeks.
    

Detailed description: 
      We hope to learn whether ropinirole CR (controlled release formulation) is safe and effective
      when taken with an antidepressant to reduce the symptoms of depression. Adults who have a
      diagnosis of major depression and are currently taking an adequate dose of antidepressant
      medication will be sought for participation. They will continue to take the antidepressant
      medication and will receive ropinirole CR, an investigational medication, for eight weeks
      during which information will be collected about mood and cognitive functioning.
    

Intervention name(s): Ropinirole CR
Intervention type(s): Drug
Intervention MeSH terms: Ropinirole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of OZ439 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Volunteers
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      A single centre, open, controlled study using Blood Stage Plasmodium falciparum challenge
      inoculum (BSPC) as a model to assess the effectiveness of three dose levels of the
      experimental anti-malarial product, OZ439.
    

Detailed description: 
      This was a single center study using blood stage Plasmodium falciparum challenge inoculum to
      characterize the effectiveness of OZ439 against early blood stage Plasmodium Falciparum
      infection.

      The study was conducted in three cohorts (n=8) using different doses of OZ439. Dose
      escalation took place after review of the observed OZ439 safety and pharmacodynamic outcome
      for the previous cohort by the Safety Review Team.

      Single doses of 100 mg, 200 mg and 500 mg were administered orally to participants in Cohort
      1, Cohort 2 and Cohort 3 respectively.
    

Intervention name(s): OZ439
Intervention type(s): Drug
Intervention description(s): OZ439 Powder for Oral Suspension
Intervention MeSH terms: Artefenomel
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Study of Gamma-hydroxy Butyrate Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome
Condition: Alcohol Withdrawal Syndrome; Alcohol Dependence
MeSH terms: Syndrome; Alcoholism; Substance Withdrawal Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Benzodiazepines (BDZs) are the gold standard in the treatment of alcohol withdrawal syndrome
      (AWS). Gamma-Hydroxybutyric acid also known as sodium oxybate (SMO) has been tested as a
      treatment for AWS with encouraging results. Aim of this phase IV, multicenter randomized
      double-blind, double dummy study is to evaluate the efficacy of SMO in comparison to oxazepam
      in the treatment of alcohol withdrawal symptoms (AWS).
    

Detailed description: 
      This is a phase IV, multicenter randomized (1:1), active drug-controlled study (double-blind,
      double dummy) with parallel groups evaluating the efficacy of SMO versus oxazepam in the
      treatment of AWS in alcohol-dependent patients.

      A placebo-controlled design was considered but excluded, given that a gold standard treatment
      for AWS is available (i.e., BDZs).

      Furthermore, considering that SMO and oxazepam have two different pharmaceutical formulation
      (suspension and tablets, respectively), a double-dummy design was adopted.

      Thus, all subjects will receive both medications, tablets (oxazepam or placebo) and
      suspension (SMO or placebo), at the same time.
    

Intervention name(s): Sodium Oxybate (SMO); Oxazepam
Intervention type(s): Drug; Drug
Other intervention name(s): Gamma-hydroxy butyrate (GHB)
Intervention MeSH terms: Sodium Oxybate; Oxazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcohol withdrawal syndrome; treatment; sodium oxybate; oxazepam
Open-Label Safety Study of AXS-05 in Subjects With Depression
Condition: Major Depressive Disorder; Treatment Resistant Depression; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 3

Summary: 
      An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder
      (MDD), including treatment resistant depression.
    

Detailed description: 
      A multi-center, open-label, long-term study to evaluate the safety and efficacy of AXS-05 in
      patients with major depressive disorder, including treatment resistant depression, treated
      for up to one year.
    

Intervention name(s): AXS-05 (dextromethorphan and bupropion) oral tablets
Intervention type(s): Drug
Intervention description(s): Oral tablets, taken twice daily for up to 12 months.
Intervention MeSH terms: Dextromethorphan; Bupropion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; AXS-05; Dextromethorphan; Bupropion; Dopamine Reuptake Inhibitor; NMDA Receptor Antagonist; Nicotinic Acetylcholine Receptor Antagonist; Serotonin Reuptake Inhibitor; Axsome Therapeutics; Norepinephrine Reuptake Inhibitor; Sigma-1 Receptor Agonist; Glutamate Modulator; Antidepressant