bioihbjkbjnl/mcl2 huggingface dataset:
The Effectiveness of Tibial Nerve Mobilization in Patients With Tarsal Tunnel Syndrome
Condition: Nerve Compression Syndromes; Neuropathic Pain
MeSH terms: Neuralgia; Nerve Compression Syndromes; Charcot-Marie-Tooth Disease; Hereditary Sensory and Motor Neuropathy; Tarsal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      This randomized, clinical, single-blinded, controlledstudywasinitiallyplannedtoinclude 35
      patients diagnosed with tarsal tunnel who applied to Kütahya Health Sciences University,
      Evliya Çelebi Training and Research Hospital, Physical Medicine and Rehabilitation outpatient
      clinic.Patients aged 20-55 years who were diagnosed with tarsal tunnel syndrome by
      electromyography (EMG) in the last 6 months were included in the study. The patients were
      randomized into two groups using the computer-assisted randomization method. Tibial nerve
      mobilization and foot-ankle range of motion exercises will be given to the study group, and
      only foot-ankle joint range of motion exercises will be given to the control group. All the
      patients were evaluated with the Visual Analog Scale (VAS), Foot Functional Index (FFI),
      Neuropathic Pain QuestionnaireN (NPQ) and Tibial Nerve ultrasonography before the
      intervention and at the fourth week of intervention.
    


Intervention name(s): Tibial Nerve Mobilization; Foot-ankle range of motion exercises
Intervention type(s): Other; Other
Intervention description(s): The person performing tibial nerve mobilization will start mobilization by keeping the lower extremity in a horizontal position, with the patient's hip and knee in 45° flexion and ankle in neutral position. Then, in order to mobilize the tibial nerve better, the patient will bring the patient's toes to the extension position, the ankle to the dorsiflexion and eversion position, and the knee joint to the extension to provide appropriate stabilization. Finally, while the patient is in this position, mobilization will be completed by plantar flexion of the distal ankle and flexion of the toes to allow the nerve to slide further distally. This mobilization technique will be performed by an experienced physician/physiotherapist twice a week for 4 weeks, and the patients will be given 5 sets of 10 cycles with a 1-minute rest period in each set.; In exercise program, foot-ankle joint range of motion exercises will be given. In our study, all exercises will be explained and performed once under the supervision of a physiotherapist, and then the participants will be asked to do all exercises with 10 repetitions, 3 times a day, for four weeks, without the supervision of a physiotherapist.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Heart Rate Variability in Children With Traumatic Brain Injury
Condition: Traumatic Brain Injury; Child Development
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Observational

Summary: 
      Using a prospective cohort of children admitted to the PICU, the investigators will determine
      HRV monitoring is feasible, if a decreased HRV in the 7 days following moderate or severe TBI
      in children is associated with a worse outcome 6 months post-TBI and investigate HRV as a
      tool that can predict adverse events (neurological crisis) within 2 days following TBI.
    

Detailed description: 
      This is a single center prospective cohort study of 15 children <18 years, admitted to the
      PICU at the CHU Sainte-Justine (CHUSJ) with moderate or severe TBI (<24 hours).
      Neurodevelopment outcome of children will be evaluated 6 months post TBI.
    

Intervention name(s): HRV monitoring
Intervention type(s): Diagnostic Test
Intervention description(s): HRV monitoring derived from electrocardiogram
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children requiring PICU admission after TBI
Chemotherapy and Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
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 chemotherapy with autologous bone marrow transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by autologous
      bone marrow transplantation in treating patients with chronic myelogenous leukemia.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the ability of c-myb antisense oligodeoxynucleotide to purge bone
      marrow cells of clonogenic chronic myelogenous leukemia tumor cells and repopulate the bone
      marrow with normal stem cells in patients treated with high-dose busulfan and
      cyclophosphamide followed by autologous bone marrow transplantation using marrow treated with
      c-myb antisense oligodeoxynucleotide. II. Determine the response rate, degree of
      hematopoietic reconstitution, overall survival, and relapse-free survival of patients treated
      with this regimen. III. Determine the toxicity of this regimen in these patients.

      OUTLINE: Patients undergo bone marrow harvest. The bone marrow is treated with c-myb
      antisense oligodeoxynucleotide and cryopreserved. A portion of the marrow is cryopreserved
      untreated in case of engraftment failure. Patients receive oral busulfan every 6 hours on
      days -7 to -4 for a total of 16 doses. Patients receive cyclophosphamide IV over 1 hour on
      days -3 and -2. Bone marrow is reinfused on day 0. Patients receive filgrastim (G-CSF)
      subcutaneously daily beginning on day 0 and continuing until blood counts recover. Patients
      are followed every 2-3 months for 2 years.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 18-24 months.
    

Intervention name(s): c-myb antisense oligonucleotide G4460; filgrastim; busulfan; cyclophosphamide; autologous bone marrow transplantation; in vitro-treated bone marrow transplantation
Intervention type(s): Biological; Biological; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Cyclophosphamide; Busulfan
Primary purpose: Treatment
Keywords: relapsing chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; accelerated phase chronic myelogenous leukemia
Efficacy of an Early Antipsychotic Switch in Case of Poor Initial Response to the Treatment of Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The main aim of the trial is to study whether a change of medication in non-responders to a
      two-weeks antipsychotic drug trial is more effective than continued treatment with the same
      antipsychotic. Hypothesis: Non-responders who are switched at 2 weeks to another
      antipsychotic are more frequently in symptomatic remission at week 8 than non-responders who
      stay on the same antipsychotic
    

Detailed description: 
      The patients will be randomised to a double-blind 2 week run in phase with fixed doses of
      either oral amisulpride 800 mg/day or olanzapine 20mg/day.

      Those participants who have not responded to treatment at two weeks (PANSS improvement <25%)
      will be randomised to a 6 week double blind flexible dose phase:

        1. Experimental intervention: switch to the other antipsychotic (oral olanzapine 5-20mg/d
           or oral amisulpride 200-800 mg/d)

        2. Control intervention: continuation with the same drug as in the first 2 weeks in
           flexible dose ranges as above for another six weeks Those participants who have
           responded at week 2 (≥25% PANSS reduction) will continue on the same drug in flexible
           dose ranges as above Total duration of intervention per patient: 8 weeks
    

Intervention name(s): Olanzapine or amisulpride
Intervention type(s): Drug
Intervention description(s): Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding
Intervention MeSH terms: Olanzapine; Amisulpride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Deep Brain Stimulation for the Treatment of Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The purpose of this clinical study is to investigate the safety and efficacy of deep brain
      stimulation (DBS)as a treatment option for patients with cognitive, behavioral, and
      functional disability of Alzheimer's disease.
    

Detailed description: 
      Open label pilot study

        -  Expected direct benefit on the modulation of neuronal networks.

        -  Expected indirect benefit via potential enhancements of memory, executive functions,
           cognition behavioral control, and functional abilities.

      Up to 10 subjects will be implanted with bilateral DBS systems, participants are expected to
      be on study for about 23 months.

        -  Develop a multidisciplinary clinical research protocol to evaluate the efficacy of
           ventral striatum, nucleus accumbens, and internal capsule for the amelioration of
           disability caused by Alzheimer's Disease.

        -  Enroll up to 10 patients into an open label study to evaluate the safety and efficacy of
           DBS for Alzheimer's Disease patients with mild to moderate disability.

        -  Determine an initial DBS titration and stimulation settings protocol for use in
           subsequent controlled trials.

        -  Evaluate the outcomes of this study based on clinical, laboratory, biomarker, imaging,
           cognitive, behavioral, and functional assessments.

        -  Determine what domains of cognitive, behavioral and functioning impairment show the
           greatest response to DBS.

        -  Examine the potential benefit of stimulation combined with behavioral and rehabilitation
           interventions in comparison to stimulation alone.

        -  Evaluate the influence of DBS on physiological and functional changes in cortical and
           subcortical networks.
    

Intervention name(s): Deep Brain Stimulation
Intervention type(s): Device
Intervention description(s): Implanted device
Other intervention name(s): Deep Brain Stimulation Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
A Clinical Pharmacology Study of MT-3921 in Healthy Adult Males
Condition: Healthy Adult Males
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics
      when MT-3921 or a placebo is intravenously given to Japanese healthy adult male subjects
    


Intervention name(s): MT-3921; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Solution for infusion; Intravenous (IV); Solution for infusion; Intravenous (IV)
Other intervention name(s): Unasnemab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Randomized Trial Comparing PrePex Day 7 Foreskin Removal Procedure (FRP) to a Day 0 PrePex FRP .
Condition: Male Circumcision
Study type: Interventional

Summary: 
      A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 (FRP) to a PrePex Day 0
      FRP of Male Circumcision in Resource Limited Settings.
    

Detailed description: 
      Study Objectives:

      To compare the safety and acceptability of PrePex Day 7 Foreskin Removal Procedure (FRP)
      (herein: PrePex) versus PrePex Day0 FRP

      Planned Subjects Population:

      One hundred and fifty (150) subjects scheduled for voluntary medical male circumcision. The
      subjects will be randomly divided into two unbalanced study arms (2:1), Day0 FRP arm which
      will include hundred (100) subjects and PrePex arm which will include fifty (50) subjects.

      Study duration per subject will be up to 7 weeks and will include a total of 9 visits.

      Study Site: University of Nairobi, Illinois, and Manatoba (UNIM) Research and Training
      Centre, Kisumu, Kenya
    

Intervention name(s): PrePex Day 7 FRP; PrePex Day 0 FRP
Intervention type(s): Device; Device
Intervention description(s): Standard PrePex procedure, foreskin and device are removed 1 week after device application.; Removal of the foreskin shortly after device application, the device is removed 1 week later
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Prospective, Randomized, Open Label Trial.
Masking: None (Open Label)
Primary purpose: Prevention
A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and tolerability of BMS-708163 in
      patients with mild to moderate Alzheimer's disease over a treatment period of 12-weeks and
      the course of any potential effects during a 12-week wash-out period
    


Intervention name(s): BMS-708163; BMS-708163; BMS-708163; BMS-708163; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Capsules, Oral, 25 mg, once daily, 24 weeks; Capsules, Oral, 50 mg, once daily, 24 weeks; Capsules, Oral, 100 mg, once daily, 24 weeks; Capsules, Oral, 125 mg, once daily, 24 weeks; Capsules, Oral, 0 mg, once daily, 24 weeks
Intervention MeSH terms: BMS 708163
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Conventional Versus 3-D Printed Complete Denture Regarding Retention, Accuracy, Elctromyographic Activity and Patient Satisfaction.
Condition: Edentulous Mouth
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      Analyzing and comparing the retention, accuracy, EMG and patient satisfaction of maxillary
      complete denture base fabricated by conventional and rapid prototyping techniques.
    


Intervention name(s): 3D Printed Complete Dentures
Intervention type(s): Other
Intervention description(s): Denture bases printed from a pre-polymerized block via additive technique, using photon S desktop 3D printer* that relies on SLA technology and post cured by post curing unit.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study to Test the Blood to See if a New Medicine is Likely to Provide Pain Relief Similar to a Product Already Sold in Stores
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess bioequivalence between one test and one reference
      formulation used for temporary relief of pain. The results will help decide if the new
      medicine is likely to provide pain relief similar to the product being sold.
    

Detailed description: 
      The study is a single dose, randomized, two-way crossover study in 32 healthy male and female
      volunteers, minimum of 14 of each gender. Two doses of study medication will be given as
      single doses on two separate treatment visits. A washout of at least 48 hours will separate
      the treatment visits. Each visit will include an overnight fast at the clinic and 19 blood
      samples drawn for pharmacokinetic analyses. Tolerability of the treatments will be evaluated
      in terms of reported and observed adverse events (AE).
    

Intervention name(s): Ibuprofen; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): A single 5 mL dose of 200 mg ibuprofen/5 mL experimental suspension, administered orally, with a 48-hour washout between visits; A single 5 mL dose of 200 mg ibuprofen/5 mL reference suspension, administered orally, with a 48-hour washout between visits
Other intervention name(s): Not yet marketed.; Nurofen for Children Six Plus
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics
Connecting the Lab to Everyday Life: The Relevance of Executive Dysfunction to Participation and Quality of Life in Parkinson's Disease (PD) Without Dementia
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Dementia
Study type: Observational

Summary: 
      The overall purpose of this research is to learn how Parkinson's disease affects thinking and
      memory in everyday life. Participation will involve thinking tests, questionnaires and
      interviews about thinking and activities in everyday life.
    

Detailed description: 
      The overall purpose of this research is to learn how Parkinson's disease affects thinking and
      memory in everyday life. Participation will involve thinking tests, questionnaires and
      interviews about thinking and activities in everyday life.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Controls:

        Recruited from community, VFH.
      
Keywords: Parkinson's Disease
Evaluation of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of E2609 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this single-center, randomized, double-blind, placebo-controlled, study is to
      evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when
      administered to healthy elderly subjects.
    


Intervention name(s): E2609; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): E2609 to be administered for 14 days, concurrently with placebo controls. Doses will be 25, 50, and 200 mg once daily by the oral route, each dose administered to a separate cohort (group) of subjects. After each dose has been administered to all subjects in a given cohort, safety and tolerability findings will be evaluated and a decision made by the sponsor and investigators as to whether or not to proceed to the next higher dose.; E2609 to be administered for 14 days, concurrently with placebo controls. Doses will be 25, 50, and 200 mg once daily by the oral route, each dose administered to a separate cohort (group) of subjects. After each dose has been administered to all subjects in a given cohort, safety and tolerability findings will be evaluated and a decision made by the sponsor and investigators as to whether or not to proceed to the next higher dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effectiveness of Green Color Exposure on Dental Anxiety
Condition: Anxiety, Dental; Post Operative Pain
MeSH terms: Pain, Postoperative; Anxiety Disorders
Study type: Interventional

Summary: 
      The investigator's aim in this study was to evaluate the preoperative anxiety and the pain
      felt during the operation due to exposure to green light. For this purpose, the participants
      will wear green or translucent glasses before the operation. The investigator will evaluate
      the patient's anxiety change and the pain she/he feels during the procedure.
    


Intervention name(s): Green light exposure; Normal light exposure
Intervention type(s): Other; Other
Intervention description(s): The experimental group wears green color glasses ten minutes before surgery until it ends.; The control group wears green color glasses ten minutes before surgery until it ends.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adaptive Closed Loop Neuromodulation and Neural Signatures of Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Continuous deep brain stimulation (cDBS) is an established therapy for the major motor signs
      in Parkinson's disease. Currently, cDBS is limited to "open-loop" stimulation, without
      real-time adjustment to the patient's state of activity, fluctuations and types of motor
      symptoms, medication dosages, or neural markers of the disease. The purpose of this study is
      to determine if an adaptive DBS system, responding to patient specific, clinically relevant
      neural or kinematic feedback, is efficacious on the motor Unified Parkinson's Disease Rating
      Scale (UPDRS III) and specific phenotypic measures in Parkinson's Disease compared to OFF
      therapy (i.e., OFF DBS and withdrawn from medication) and more efficient than cDBS. Not every
      recruited participant completed every part of the protocol.
    


Intervention name(s): Adaptive DBS (Activa PC+S Neurostimulator); Continuous DBS (Activa PC+S Neurostimulator)
Intervention type(s): Device; Device
Other intervention name(s): Adaptive deep brain stimulation; continuous deep brain stimulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects
Condition: Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess possible drug-drug interactions with specific isoenzymes over a total
      study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples
      collected post dose will be analyzed.
    

Detailed description: 
      This is an open-label, multiple-dose, non-randomized study to assess the drug-drug
      interactions of Proellex® with cytochrome P450 isoenzymes in healthy female subjects. On Day
      1, following an overnight fast and morning void of the bladder, subjects will be administered
      CYP probe drugs orally. Serial blood samples will be collected at pre-dose and post-dose.
      Subjects will be administered two Proellex® 25 mg capsules (50 mg total dose) at
      approximately 0800 hours on Day 2 and 0700 hours on Days 3 through 8. One hour after
      administration of Proellex® on Day 8, the five CYP probe drugs will be administered and blood
      and urine samples collected as on Day 1. Blood samples for the determination of plasma
      concentrations of CDB-4124 and its metabolite CDB-4453 will be collected at pre-dose (trough)
      on Days 6, 7, and 8 to determine if steady-state conditions have been achieved. Samples will
      also be collected on Day 8 at 1, 2, 8 and 24 hour after administration of Proellex® to
      determine the plasma concentrations of CDB-4124 and CDB-4453.
    

Intervention name(s): Proellex; CYP1A2 probe; CYP2C9 probe; CYP2C19 probe; CYP2D6 probe; CYP3A4 probe
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2, 25 mg Proellex capsules administered daily; Caffeine (200 mg); Tolbutamide (250 mg); Omeprazole (20 mg); Dextromethorphan (30 mg); Midazolam (2mg)
Other intervention name(s): Telapristone acetate; Caffeine (200 mg); Tolbutamide (250 mg); Omeprazole (20 mg); Dextromethorphan (30 mg); Midazolam (2mg)
Intervention MeSH terms: Tolbutamide; Midazolam; Dextromethorphan; Caffeine; Omeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug-drug interactions; DDI