bioihbjkbjnl/mcl2 huggingface dataset:
Hormone and Information Processing Study
Condition: Mild Cognitive Impairment; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the effects of testosterone (T) replacement on
      changes in thinking and memory, as well as mood in older men with mild cognitive impairment
      (MCI) and low T levels. The study will also examine whether taking testosterone has effects
      on biological markers related to Alzheimer's disease.
    

Detailed description: 
      Natural age related declines in testosterone (T) are associated with decreases in cognitive
      abilities independent of health status. Low T levels over time are associated with increased
      risk for developing Alzheimer's disease (AD). These findings suggest that men with low T
      levels are most at risk for age-related cognitive decline and AD and therefore most likely to
      benefit from T supplementation to prevent the development of AD or age-associated cognitive
      decline. The current study will assess cognition, mood, and cerebral spinal fluid (CSF)
      biomarker response to T supplementation in older men with mild cognitive impairment (MCI) and
      low T levels.

      Participants will be randomized to either receive T treatment or a placebo for six months.
      Participants will come in for about five visits within the span of six months where they will
      complete cognitive & memory tests, fill out mood questionnaires, and have their blood drawn
      to monitor the medication level. A sample of blood will also be taken at one visit to test
      for apolipoprotein E (APOE), which is a genetic risk factor associated with AD. Participants
      will have the option to get a spinal tap in order to measure biological markers associated
      with Alzheimer's disease including beta-amyloid 1-40, 42, total-tau, and
      phosphorylated-tau-181-231. This will require an additional two visits.
    

Intervention name(s): testosterone gel; placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): 50-100mg applied topically daily for six months; applied topically daily for six months
Other intervention name(s): Solvay Testosterone Gel
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: selective androgen receptor modulators (SARMs); hormone replacement therapy; age-associated cognitive decline; testosterone supplementation
Comparison of TRIA-662 500 mg and Niaspan 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the absorption of a niacin metabolite
      (1-methylnicotinamide, 1-MNA) from TRIA-662 (1-methylnicotinamide chloride)relative to the
      production of 1-MNA from Niaspan. The 1-MNA information obtained from this study will be used
      to adjust the top dose of a planned TRIA-622 efficacy study.
    


Intervention name(s): Niaspan; TRIA-662
Intervention type(s): Drug; Drug
Other intervention name(s): Extended-release nicotinic acid; Extended-release niacin; 1-methynicotinamide chloride; N-methylnicotinamide chloride; MNA chloride; 1-MNA chloride
Intervention MeSH terms: Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioavailability
A Pilot Study of Constraint Induced Movement Therapy in Preschool Cerebral Palsy After Botulism Toxin Injection
Condition: Cerebral Palsy, Spastic; Rehabilitation
MeSH terms: Botulism; Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      To establish a pilot randomized, crossover study on applying 2 constraint-induced movement
      therapy (CIMT) interventions in children with hemiplegic cerebral palsy after botulinum toxin
      injection during preschool education.
    

Detailed description: 
      This study was designed to be a pilot study on the use of 4-week 2-hours/day and 2-week
      4-hours/day CIMT interventions in children with hemiplegic CP after a BoNT-A injection in
      preschool education, and compared the effects and psychological stress of CP children
      relative to the 2 CIMT programs.
    

Intervention name(s): 40-hour constraint-induced movement therapy
Intervention type(s): Procedure
Intervention description(s): Participants were randomly allocated to 1 of 2 CIMT programs (40 hours): a 2-week 4-hours/day CIMT program and a 4-week 2-hours/day CIMT program. One CIMT program was performed 1 month after a BoNT-A injection, and then the second program was implemented with the next injection.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cerebral palsy; constraint-induced movement therapy; botulinum toxin; rehabilitation; occupational therapy
Safety and Immunogenicity Study of Two Doses of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objectives of this Phase I/II study are to assess the safety and immunogenicity of two
      different dose levels of a non-adjuvanted H5N1 influenza vaccine in a healthy young adult
      population. Subjects will be randomized 1:1 to receive two intramuscular injections (21 days
      apart) of the vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in
      a non-adjuvanted formulation. Subjects will be monitored for safety and for antibody response
      to the vaccine. A data safety monitoring board will review the safety data after the first
      and second vaccination.
    


Intervention name(s): Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation
Intervention type(s): Biological
Intervention description(s): Subjects will be randomized 1:1 to receive two intramuscular injections of the whole virion, Vero cell-derived influenza vaccine containing either 3.75 mg or 7.5 mg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation on Day 0 and Day 21.
Intervention MeSH terms: Hemagglutinins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pandemic influenza
Evaluation of Injectable Beta-tricalcium Phosphate Clinically in Treatment of Grade II Furcation Involvement
Condition: Furcation Defects
MeSH terms: Furcation Defects
Study type: Interventional

Summary: 
      This study will be conducted to evaluate clinically and radiographically the use of PD
      VitalOs cement® bone graft in the treatment of class II furcation defects comparing with
      Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II
      furcation defects.
    

Detailed description: 
      The study is a randomized, controlled clinical trial. Patients were randomly divided into two
      equal groups, Group I (Test group): included seven Grade II furcation defects treated by beta
      tricalcium phosphate bone cement only.

      Group II (Control group): included seven Grade II furcation defects treated with granulated
      beta tricalcium phosphate bone graft covered by resorbable collagen membrane.
    

Intervention name(s): PD VitalOs cement®; Hydroxyapatite bone graft; biodegardable collagen membrane
Intervention type(s): Other; Other; Other
Intervention description(s): PD VitalOs cement®* is a synthetic bone grafting cement designed for bone void filling and bone regeneration in dental surgery; a bioceramic bone substitute, providing a scaffold for bone deposition; provide efficacious barriers that were interposed between the flap and root surface.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Grade II Furcation defects
Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema
Condition: Lymphedema
MeSH terms: Lymphedema
Study type: Interventional

Summary: 
      This is a randomized, controlled, parallel group, open label, clinical trial to evaluate the
      effectiveness of intermittent, gradient, pneumatic compression (IPC)on the healing of venous
      ulcers in subjects diagnosed with chronic secondary lymphedema. Time to complete healing,
      healing rates, edema, wound pain, granulation tissue, and wound exudate (type and amount)
      will be compared between the IPC-treated group (IPC plus standard compression)and control
      (standard compression alone).
    


Intervention name(s): Intermittent, gradient, pneumatic compression device
Intervention type(s): Device
Intervention description(s): lymphedema pump provides external compression in a segmental,gradient fashion
Other intervention name(s): Bio 4000 (Bio Compression Inc, Moonachie,NJ)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: venous ulcer; secondary lymphedema; chronic lower leg ulceration
Add-on Nighttime Bracing in Adolescent Idiopathic Scoliosis
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      Bracing is an accepted standard therapy for idiopathic scoliosis at Cobb angle ranges between
      25° and 45°. However, it is unclear, if a specifically tailored regimen of daytime and
      nighttime braces (=double brace) yields superior results compared to the standard treatment
      (single brace for day and night). These two treatment regimens were investigated in the
      study.
    

Detailed description: 
      One-hundred-fifteen patients with adolescent idiopathic scoliosis (AIS) were assessed before
      initiation of bracing treatment and at the final follow-up 2 years after deposition of the
      brace. They were divided into two groups: double-brace group and single-brace group. Each
      patient underwent clinical and radiological examinations and Cobb angles were measured.
    

Intervention name(s): Brace therapy
Intervention type(s): Procedure
Intervention description(s): A Chêneau-type brace was made to be worn as a full-time brace or during daytime only (double-brace group), whereas the nighttime brace was produced according to the Charleston approach.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with AIS were managed as recommended by SOSORT Consensus statement. Inclusion
        criteria were according to the Scoliosis Research Society criteria. Initial diagnostics
        included a clinical examination, standardized X-ray of the entire spine in standing
        position. Patients for whom cost coverage of double-brace therapy was denied by the health
        insurance company received a single full-day and nighttime Chêneau type brace treatment.
        All other patients received a Chêneau brace for daytime and a Charleston type nighttime
        bending brace. Patients who were prescribed the brace were instructed to wear it for 23
        hours/day. Patients were seen at 6-month intervals, at which times we collected
        radiographic, clinical, orthotic, and self-reported data.
      
Keywords: scoliosis; nighttime bracing; full-time bracing; Chêneau brace; Charleston brace
Neutral Correlates of Risk-taking in Adolescents Exposed to Drugs Prenatally
Condition: Exposure
Study type: Observational

Summary: 
      Objective- To use fMRI to compare brain activity at rest and during memory and decision
      making tasks in normal children and in children exposed in utero to drugs of abuse.

      Study population- All participants will be 14-20 year-olds enrolled in an ongoing
      longitudinal follow up study of children exposed to drugs of abuse in utero funded by NIH. A
      subgroup of this study cohort will be invited to participate based on added criteria needed
      for scanning studies, such as absence of metal in the body, no significant CNS disease, and
      ability to tolerate the scanning environment.

      Design- Participants will undergo fMRI scans while performing a memory task, a decision
      making task and at rest. Data from participants in the current study may be combined with
      those from a previous study (NIDA protocol 417) which now reside in our repository protocol,
      8002 and NIDA protocol 455.

      Outcome measures- The primary outcome measures will be the difference in BOLD fMRI activation
      between drug-exposed participants and those without prenatal exposure to drugs of abuse.
    

Detailed description: 
      Objective- To use fMRI to compare brain activity at rest and during memory and decision
      making tasks in normal children and in children exposed in utero to drugs of abuse.

      Study population- All participants will be 14-20 year-olds enrolled in an ongoing
      longitudinal follow up study of children exposed to drugs of abuse in utero funded by NIH. A
      subgroup of this study cohort will be invited to participate based on added criteria needed
      for scanning studies, such as absence of metal in the body, no significant CNS disease, and
      ability to tolerate the scanning environment.

      Design- Participants will undergo fMRI scans while performing a memory task, a decision
      making task and at rest. Data from participants in the current study may be combined with
      those from a previous study (NIDA protocol 417) which now reside in our repository protocol,
      8002 and NIDA protocol 455.

      Outcome measures- The primary outcome measures will be the difference in BOLD fMRI activation
      between drug-exposed participants and those without prenatal exposure to drugs of abuse.
    

Time perspective: Other
Keywords: fMRI; Risk-Taking; Decision-Making; Memory; Resting-State Functional Connectivity
A Study to Evaluate Efficacy of 『Opast Tablet』for Neurologic Claudication in Patients With Lumbar Spinal Stenosis
Condition: Neurologic Claudication in Patients With Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Intermittent Claudication; Constriction, Pathologic
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is a comparative study of Opast tablet and Rikalin capsule 75mg and Rikalin
      capsule 75mg in combination with Opast tablet to evaluate improvement effectiveness of Opast
      tablet on subjective symptoms and neurologic claudication in patients with lumbar spinal
      stenosis.
    

Detailed description: 
      Subjects who provided written consents voluntarily after receiving a sufficient explanation
      about this trial will be assigned to one of groups(study group; limaprost, comparative group
      1; pregabalin, comparative group 2; limaprost+ pregabalin) by randomization at the rate of
      1:1:1.

      Subjects will take assigned investigational drugs thrice a day for eight weeks by
      double-blind and double-dummy methods, and they will visit the site two times at intervals of
      four weeks.

      At each site visit point, the improvement effectiveness will be comparatively evaluated by
      evaluation of following endpoints;

      Efficacy endpoints: ICD(initial claudication distance) at treadmill test (speed:3km/hr,
      grade:0%), VAS in pain on lower extremities, EQ-5D and ODI Safety endpoints: Vital signs,
      hematology/blood chemistry tests and adverse events, etc.
    

Intervention name(s): Limaprost; Pregabalin; Placebo(for Pregabalin); Placebo(for Limaprost)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): mimic Pregabalin 75mg capsule; mimic Limaprost tablet
Other intervention name(s): Opast tablet; Rikalin capsule 75mg
Intervention MeSH terms: Pregabalin; Alprostadil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Study of IBI362 in Healthy Chinese Male Subjects
Condition: Overweight/Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate the pharmacokinetic characteristics and safety of IBI362
      lyophilized powder and IBI362 liquid formulation in healthy Chinese male subjects.
    

Detailed description: 
      Pharmacokinetic；Safety
    

Intervention name(s): IBI362 liquid formulation; IBI362 lyophilized powder
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic; Safety
Study to Assess the PK Profile of NanoBUP Capsules Relative to Suboxone
Condition: Healthy
Study type: Observational

Summary: 
      Phase 1 study to determine the pharmacokinetic profile of NanoBUP Capsules to Suboxone.
    

Detailed description: 
      The pharmacokinetics of an orally administered investigational buprenorphine
      hydrochloride/naloxone hydrochloride 2 mg/0.5 mg capsule formulation will be studied. This is
      a single-dose, two period, two treatment, crossover comparative bioavailability study under
      fasting conditions.
    

Intervention name(s): Buprenorphine HCl/Naloxone HCl
Intervention type(s): Drug
Other intervention name(s): Suboxone
Intervention MeSH terms: Buprenorphine; Naloxone
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        healthy normal volunteers
      
Keywords: phase 1 study; volunteers
Dose Response Effects of Inhaled Fluticasone on Airway Effects of Hypertonic-saline in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study investigates the effect of a inhaled corticosteroid (fluticasone or "Flovent") on
      airway narrowing induced by hypertonic saline (salty water). The study hypothesis is that
      fluticasone will be more effective in preventing saline-induced airway narrowing than
      methacholine-induced narrowing.
    


Intervention name(s): Fluticasone
Intervention type(s): Drug
Intervention description(s): Inhaled Fluticasone, either 100 or 1000 mcg per day
Other intervention name(s): Flovent
Intervention MeSH terms: Fluticasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial
Condition: Spasmodic Dysphonia; Laryngeal Dystonia; Deep Brain Stimulation
MeSH terms: Dysphonia; Hoarseness; Dystonia
Study type: Interventional

Summary: 
      Laryngeal Dystonia (LD), also commonly referred to as spasmodic dysphonia, is a neurological
      voice disorder characterized by involuntary dystonic contractions of the laryngeal muscles.
      Current treatments such as botox and voice therapy only provide temporary relief and thus,
      the investigators are exploring new strategies to provide long-term, sustained improvement.

      Deep Brain Stimulation (DBS) is a neurosurgical procedure that involves the implantation of
      electrodes to deliver electrical stimuli to specific brain regions. It is the standard
      surgical treatment for many other movement disorders such as Parkinson's disease, essential
      tremor, and primary dystonia. This trial has been designed to test the hypothesis that DBS
      can improve the vocal dysfunction of LD.
    


Intervention name(s): VIM Thalamic Deep Brain Stimulation ON; VIM Thalamic Deep Brain Stimulation OFF
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis.
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an exploratory trial to evaluate the effect of antimalarial drugs on the immune
      response generated by rabies vaccine when administered for post-exposure prophylaxis. This
      study will use the FDA approved post-exposure prophylaxis vaccine regimen (without rabies
      immune globulin) in the presence or absence of an FDA-approved malaria chemoprophylaxis
      regimen.
    

Detailed description: 
      Rabies is present on all continents where U.S. military personnel deploy, including countries
      where malaria is also endemic and where U.S. military personnel are required to take malaria
      prophylaxis. Rabies post-exposure prophylaxis in unvaccinated individuals who are not on
      malaria prophylaxis consists of four, 1.0-mL intramuscular (IM) injections of the purified
      chick embryo cell (PCECV) rabies vaccine on days 0, 3, 7, and 14. The current Advisory
      Committee on Immunization Practices (ACIP) guidelines recommend that exposed persons who are
      taking malaria prophylaxis should receive a fifth dose of rabies vaccine 28 days after the
      exposure. These guidelines do not differentiate between drugs used for malaria prophylaxis
      This study will administer the post-exposure regimen to volunteers from a US population of
      military age who are taking one of three malaria prophylaxis regimens or no malaria
      prophylaxis. The goal of this study is to asses if individuals on malaria prophylaxis achieve
      the required rabies titer after completion of the four dose regimen.

      Obtaining rabies vaccine and rabies immune globulin in a deployed setting can be challenging.
      A full understanding of the requirements for protecting exposed individuals is necessary for
      appropriate decision making in a resource-constrained environment.
    

Intervention name(s): Chloroquine; Atovaquone and Proguanil; Doxycycline; Rabies Vaccine
Intervention type(s): Drug; Drug; Drug; Biological
Intervention description(s): FDA approve dosing schedule; FDA approve dosing schedule; FDA approve dosing schedule; FDA approve dosing schedule
Other intervention name(s): Chloroquine Phosphate; Malarone; Doxycycline Hyclate; RabAvert
Intervention MeSH terms: Doxycycline; Chloroquine; Chloroquine diphosphate; Atovaquone; Proguanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Evaluate the Bioavailability of Fedratinib When Administered in Different Ways to Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative bioavailability of fedratinib in
      healthy adult participants.
    


Intervention name(s): Fedratinib
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Phase 1; Fedratinib
Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis
Condition: Lyme Neuroborreliosis
MeSH terms: Lyme Neuroborreliosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the
      treatment of neuroborreliosis in a randomized controlled trial.
    


Intervention name(s): Ceftriaxone; Doxycycline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Doxycycline; Ceftriaxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Neuroborreliosis