bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
Condition: Dyskinesias; Parkinson Disease; Movement Disorders; Parkinsonian Disorders; Anti-Dyskinesia Agents
MeSH terms: Parkinson Disease; Dyskinesias; Movement Disorders; Parkinsonian Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy and safety of modified release AFQ056 in patients that
      have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)
    


Intervention name(s): AFQ056; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AFQ056 will be supplied as oral modified release tablets in 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg.
Patients will be randomized in two groups by amantadine status.
Group 1: Patients are not permitted to take amantadine within 2 weeks prior to the BL1 visit.
Group 2: Patients must be on a stable and well tolerated dose of amantadine for at least 4 weeks prior to BL1 and must maintain the stable dose of amantadine during the remainder of the study.); Placebo for AFQ056 will be supplied as oral tablets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson Disease; L-dopa; Levodopa; Dyskinesia; Amantadine
Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the
      tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation
      therapy is more effective in treating patients with non-small cell lung cancer.

      PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy
      regimens and to see how well they work in treating patients with stage I or stage II
      non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To compare the incidence of toxicity with two established stereotactic body radiotherapy
           (SBRT) regimens in patients with node-negative, peripheral stage I or II non-small cell
           lung cancer.

      Secondary

        -  To compare quality of life, patterns of failure, disease-free survival, and overall
           survival of these patients after treatment with one of two established SBRT regimens.

        -  To correlate outcomes and toxicities with imaging and patient and tumor biomarkers.

      OUTLINE: Patients are stratified according to Karnofsky performance status and treatment
      center. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).

        -  Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.

      Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires

      Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA
      and immunoblotting.

      After completion of study treatment, patients are followed for 5 years.
    

Intervention name(s): Arm 1 stereotactic body radiation therapy; Arm II stereotactic body radiation therapy
Intervention type(s): Radiation; Radiation
Intervention description(s): Patients undergo 1 high-dose fraction; Patients undergo 3 high-dose fractions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable
      kidney transplant patients converted from a Prograf® based immunosuppression regimen to a
      modified release tacrolimus based immunosuppression regimen.
    

Detailed description: 
      This is a Phase II open-label, multi-center conversion study in stable, adult kidney
      transplant recipients to assess the pharmacokinetics, safety and effectiveness of tacrolimus
      in stable kidney transplant patients converted from a Prograf® based immunosuppression
      regimen to a modified release tacrolimus based immunosuppression regimen.
    

Intervention name(s): Tacrolimus Modified Release (MR); tacrolimus
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): Advagraf; Astagraf XL; FK506E; FKMR; MR4; Prograf®; FK506
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pharmacokinetics; Therapy; Immunosuppression; Drugs, Investigational; Adult
New Quantitive MRI Parameters in Assessing Kidneys of Autosomal Dominant Polycystic Kidney Disease
Condition: Autosomal Dominant Polycystic Kidney Disease; Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Observational

Summary: 
      The purpose of this study is to establish normal Magnetic Resonance quantitative values
      (tissues stiffness, Apparent Diffusion Coefficient values and Blood Oxygen Level
      Determination values for both renal cortex and medullary tissues and total renal blood flow)
      for young Autosomal Dominant Polycystic Kidney Disease patients with normal renal function,
      and normal young adult controls without Autosomal Dominant Polycystic Kidney Disease and
      normal renal function.

      Hypothesis: Newer Magnetic Resonance quantitative imaging parameters (tissue stiffness,
      Apparent Diffusion Coefficient, Blood Oxygen Level Determination levels, Magnetization
      Transfer and renal blood flow) will have different values in young adult ADPKD patients as
      compared to normal volunteers.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Ten known ADPKD patients between the ages of 18-30, and 10 normal non-ADPKD volunteers
        between the ages of 18-30, who are MRI compatible will be studied. Study participants will
        be selected from a list queried from the Polycystic Kidney Disease database.
      
Keywords: autosomal dominant polycystic kidney disease; magnetic resonance imaging parameters; magnetic resonance elastography; apparent diffusion coefficient; blood oxygen level determinations; diffusion weighted imaging
Single and Multiple Dose Study of Miricorilant (CORT118335) Tablet Formulations in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, and pharmacokinetics (PK) of miricorilant
      (CORT118335) tablet formulations following single and multiple oral administration in healthy
      participants.
    

Detailed description: 
      Cohort 1 will evaluate safety, tolerability, and PK of single doses of a 150-mg and a new
      300-mg tablet formulation of miricorilant. Cohort 1 treatment will be randomized and open
      label.

      Optional Cohorts 2 and 3 will evaluate single- and repeated-dose administration of
      miricorilant using a formulation, dose, and dose-regimen determined after interim evaluation
      of PK and safety data from previous cohorts. Cohort 2 and 3 treatments will be randomized,
      blinded, and placebo controlled.
    

Intervention name(s): Miricorilant 300 mg tablets; Miricorilant 150 mg tablets; Placebo 150 mg tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Miricorilant 300 mg tablets for oral administration; Miricorilant 150 mg tablets for oral administration; Placebo to match miricorilant 150 mg tablets for oral administration
Other intervention name(s): CORT118335; CORT118335
Intervention MeSH terms: Cortisone
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Motor Imagery Intervention for Improving Gait and Cognition in the Elderly
Condition: Motor Activity
Study type: Interventional

Summary: 
      The investigators propose a single-blind randomized clinical trial to determine if seniors
      show improved mobility (walking speed) and cognition following motor imagery (imagined
      walking) training. They hypothesize that imagined walking can be used as a rehabilitative
      tool for improving walking speed and cognition in the elderly, because it engages and
      strengthens similar neural systems as actual walking and cognition.
    

Detailed description: 
      The proposed research aims to establish the efficacy of an imagined gait protocol for
      improving gait and cognition in the elderly. This imagined gait protocol involves imagined
      gait in single (imagined walking; iW) and dual-task (imagined walking while talking; iWWT)
      situations. A single-blind randomized clinical trial of 58 cognitively-healthy elderly with
      pre-post measures of gait, cognition, and functional Magnetic Resonance Imaging (fMRI) during
      imagined gait is proposed. The overall hypothesis is that imagined gait can be used as a
      rehabilitative tool for improving gait and cognition in the elderly because it engages and
      strengthens similar neural systems as actual gait and cognition. The first aim of this study
      is to establish the efficacy of our imagined gait protocol to improve gait and cognition in
      the elderly. We predict that our imagined gait intervention will improve gait velocity during
      actual walking and walking-while-talking conditions to a greater extent than the active
      control (visual imagery) intervention. We also predict that our imagined gait intervention
      will cognitive performance during dual-task walking conditions. The second aim of this study
      is to determine neuroplasticity changes in response to our imagined gait protocol. We predict
      that the neural systems engaged during imagined gait will change following our imagined gait
      intervention.
    

Intervention name(s): Imagined Gait Intervention; Visual Imagery Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.; Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
taVNS in Mild to Moderate Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this study is to find out whether a non-invasive form of nerve stimulation
      called transcutaneous vagus nerve stimulation (taVNS) is safe and effective in people with
      Parkinson's Disease.
    


Intervention name(s): Active taVNS; Sham Stimulation
Intervention type(s): Device; Device
Intervention description(s): Patients will be masked to transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus; Sham stimulation involves identical perceptual threshold finding and stimulation parameters as active stimulation, with the exception of stimulation target. Sham stimulation will be delivered to the left earlobe, a target believed to have little to no vagal nerve innervation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Treosulfan Based Conditioning Myelodysplastic Syndrome (MDS)
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, multinational, non-randomized, non-controlled open-label phase II
      trial to evaluate the safety and efficacy of treosulfan in a combination regimen with
      fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in
      patients with MDS.

      The aim is to demonstrate a clinical benefit compared to historical data with intravenous
      busulfan.
    


Intervention name(s): Treosulfan
Intervention type(s): Drug
Intervention description(s): 14 g/m2/d, day -6 to -4
Other intervention name(s): Ovastat
Intervention MeSH terms: Treosulfan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treosulfan; MDS; allogeneic stem cell transplantation; leukemia; Conditioning
Evaluating the Infectivity, Safety, and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine in RSV-Seronegative Infants and Children 6 to 24 Months of Age
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a
      single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in
      RSV-seronegative infants 6 to 24 months of age.

      This study is a companion study to IMPAACT 2011.
    

Detailed description: 
      Human respiratory syncytial virus (RSV) is the most common viral cause of serious acute lower
      respiratory illness (LRI) in infants and children under 5 years of age worldwide. The purpose
      of this study is to evaluate the safety, infectivity, and immunogenicity of a single dose of
      a recombinant live-attenuated RSV vaccine, RSV LID ΔM2-2 1030s, in RSV-seronegative infants 6
      to 24 months of age.

      Participants will be randomly assigned to receive a single dose of the RSV LID ΔM2-2 1030s
      vaccine or placebo (administered as nose drops) at study entry (Day 0).

      Participants will be enrolled in the study between April 1 and October 31, outside of the RSV
      season, and will remain on study until they complete the post-RSV season visit between April
      1 and April 30 in the calendar year following enrollment. Total study duration is between 6
      to 13 months, depending on when participants enroll in the study. Participants will attend
      several study visits throughout the study, and the visits may include blood collection, nasal
      washes, and physical examinations. Participants' parents or guardians will be contacted by
      study staff at various times during the study to monitor participants' health.
    

Intervention name(s): RSV LID ΔM2-2 1030s vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 10^5.0 PFU; administered as nose drops; Administered as nose drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Randomized, 4-sequence, 2-period, Double-blind, Placebo Controlled Study With a DSM-IV-TR Diagnosis of Cocaine Abuse
Condition: Opioid Dependence; Opioid Related Disorders; Cocaine Dependence
MeSH terms: Cocaine-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, 4-sequence, 2-period, double-blind, placebo controlled study in male
      and female subjects with an American Psychiatric Association Diagnostic and Statistical
      Manual DSM-IV-TR diagnosis of cocaine abuse.
    

Detailed description: 
      There will be a 28-day screening period with eligible subjects remaining resident in the
      clinic from the evening before Day -1 up and until the morning of Day 9. On the morning of
      Day 1, a 50 mg intravenous (IV) infusion of cocaine will be administered over 10 minutes to
      all subjects. If none of the stopping criteria were met and no intervening safety concerns,
      subjects will be randomized to one of the treatment sequences on Day 3. On dosing days, Day 3
      and Day 6, subjects will have fasted at least 8 hours before dosing of cocaine and either
      RBP-8000 200 mg, RBP-8000 100 mg or matching placebo.
    

Intervention name(s): RBP-8000 100 mg; Placebo; Cocaine; RBP-8000 200 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): RBP-8000 100 mg administered in the vein on either study day 3 or 6. There is a 72-hour washout between Days 3 and 6; IV infusion of Placebo administered 1 minute after cocaine infusion on either day 3 or 6.; 50 mg intravenous (IV) dose of cocaine administered over 10 minutes on Days 1, 3 and 6.; RBP-8000 200 mg administered in the vein on either study day 3 or 6. There is a 72-hour washout between Days 3 and 6
Other intervention name(s): T172R/G173G cocaine esterase; Benzoylmethylecgonine; T172R/G173G cocaine esterase
Intervention MeSH terms: Cocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cocaine
Safety Study of NNZ-2566 in Healthy Subjects, Following Oral Administration
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to obtain evidence of safety and determine the pharmacokinetics
      (PK) of NNZ-2566 in healthy volunteers, when administered orally.
    

Detailed description: 
      Double-blind, placebo-controlled, randomized (with a 6:2 randomization for active versus
      placebo) safety, dose-escalation, and pharmacokinetic study of NNZ-2566.

      Three cohorts will be sequentially dosed, starting with two cohorts receiving a single dose
      (6mg/kg followed by 30mg/kg). The third cohort will receive two 100mg/kg doses over the
      course of one day and following a formal safety review the same subjects will then receive
      two 100mg/kg doses each day for five days.
    

Intervention name(s): NNZ-2566; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Glycyl-L-2-Methylprolyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with lemon flavoured cordial and Water for Injection.; Lemon flavoured cordial and Water for Injection
Other intervention name(s): NNZ-2566 Lot NNZP25; Bickford's Bitter Lemon Cordial, 1:1 in Water for Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Carboplatin Plus Topotecan in Treating Patients With Relapsed Acute Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining carboplatin and topotecan in
      treating patients with relapsed acute myelogenous leukemia.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy of a 5-day continuous infusion of carboplatin and
      topotecan in patients with relapsed and refractory acute myelogenous leukemia (AML). II.
      Assess the toxic effects of this treatment in these patients.

      OUTLINE: Patients receive continuous intravenous infusions of topotecan and carboplatin for 5
      days. Treatment repeats every 3-4 weeks during induction (two courses) and every 6-10 weeks
      during consolidation. No more than four courses of treatment are given. Patients are followed
      every 6 months for 5 years.
    

Intervention name(s): carboplatin; topotecan hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Carboplatin; Topotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult acute myeloid leukemia; secondary acute myeloid leukemia
A Safety Study of Dapivirine Vaginal Ring in Africa
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety
      of a silicone elastomer vaginal ring containing 25mg dapivirine.
    


Intervention name(s): Dapivirine; Placebo
Intervention type(s): Other; Other
Intervention description(s): Vaginal ring containing 25mg dapivirine; One ring inserted every 28 days for 84 days (3 rings total); Vaginal Ring containing no drug substance
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: HIV infections; Anti-HIV agents; HIV-1
ORTHOVISC Shoulder Osteoarthritis Study
Condition: Glenohumeral Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to
      osteoarthritis.
    

Detailed description: 
      This multicenter, prospective double-blinded, randomized trial will study two treatment
      groups. Subjects will be randomized to receive either Orthovisc or corticosteroids/anesthetic
      injection into the shoulder in a 2:1 schema. The trial will assess safety and efficacy of
      pain relief in the osteoarthritic shoulder.
    

Intervention name(s): Orthovisc; Control
Intervention type(s): Device; Drug
Intervention description(s): Orthovisc injection; Celestone (betamethasone sodium phosphate and acetate) - 2 mL
Other intervention name(s): Hyaluronic acid; Corticosteroid
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Orthovisc; Osteoarthritis; Shoulder; Randomized