bioihbjkbjnl/mcl2 huggingface dataset:
Combined Behavioral/Pharmacological Therapy for Insomnia
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine how sleeping pills can be combined with nondrug treatments to
      maximize the benefits of therapy for insomnia.
    

Detailed description: 
      Long-term insomnia is a common and significant health problem. Two main treatments,
      pharmacotherapy and behavioral therapy, have been used to help people with insomnia. Because
      both treatments have advantages and disadvantages, a combination of these treatments may be a
      good way to treat insomnia.

      During the first 2 weeks of the study, participants keep a sleep log, wear an actigraph (a
      device that resembles a wristwatch and records activity to help determine when participants
      are asleep or awake), and complete questionnaires.

      Participants are then randomly assigned to receive 6 weeks of behavioral therapy plus
      zolpidem tartrate (Ambien), behavioral therapy plus placebo, or behavioral therapy alone.
      During treatment, participants return to the clinic once a week to turn in their sleep logs,
      download their actigraph, and complete questionnaires.

      After 6 weeks, participants enter the post-treatment phase of the study, which lasts 2 weeks
      and is identical to the 2-week assessment at the beginning of the study.

      After the post-treatment phase, participants enter the follow-up period and are contacted at
      3 months, 6 months, and 1 year to complete another 2-week assessment with sleep logs,
      actigraphy, and questionnaires.
    

Intervention name(s): Cognitive-Behavioral Therapy for Insomnia; zolpidem tartrate (Ambien); Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Sleep Deprivation; Insomnia; Sleep Disorders
Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Randomized, Rater and Participant Blinded Placebo Controlled Study to Evaluate the
      Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose
      of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Array Patch (MAP) System) in
      Healthy Adults ≥18-39 Years of Age
    


Intervention name(s): H1 influenza antigen
Intervention type(s): Biological
Intervention description(s): Either 7.5 μg or 15 μg of the H1 influenza antigen
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Metrological Characteristics of the Inertial Unit "FOX HiKoB©" in Comparison With the Reference System for the Adaptive Trigger System "Functional Electrical Stimulation" of Foot Elevators in Hemiplegic Post-stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      The main objective of this study is to evaluate the metrological characteristics of the data
      processing algorithms from inertial sensors (FOX © HiKoB) for the reconstruction of movement
      relative to the reference system (VICON) for measurement of dorsiflexion at the beginning of
      a step and in the middle of the oscillating phase.
    

Detailed description: 
      The secondary objectives of this study are:

        1. / - to assess the metrological characteristics of the data from inertial sensors (FOX ©
           HiKoB) for the reconstruction of the movement in comparison with reference systems
           (GaitRite or Zebris systems, VICON) in terms of:

           A. Ability to determine the walking speed, stride length, the acceleration of plantar
           flexion at the beginning of the weight-bearing phase B. Ability to objectify performance
           reduction during a 6 minute test. C. Ability to identify different types of movement:
           simple walking, turn, obstacle clearance, staircase.

        2. / - to analyze the EMG signal upon voluntary dorsiflexion of the foot of the paretic
           side from a sitting position before and after a fatigue test (objective D)
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population consists of patients whose age is between 20 and 75 years and who
        experienced a supra-tentorial ischemic or hemorrhagic stroke. The study covers inpatients
        or patients consultating in the neurological rehabilitation service (NHS) at the Grau du
        Roi Medical Center, Nîmes University Hospital.
A Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose is to investigate the safety and efficacy of SPM927 in patients with
      Painful Diabetic Neuropathy
    


Intervention name(s): SPM927/Lacosamide; Placebo
Intervention type(s): Drug; Other
Intervention description(s): SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage 400mg/day, intake in the morning and in the evening, intake for 10 weeks; Placebo tablets two times a day for 10 weeks
Other intervention name(s): SPM927; Lacosamide; Vimpat®
Intervention MeSH terms: Lacosamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lacosamide, Vimpat®
CASUS: Validation for Detection of Precursor Lesions
Condition: Cervical Cancer; Cervical Intraepithelial Neoplasia; Human Papilloma Virus; HPV-Related Cervical Carcinoma; Urine
MeSH terms: Uterine Cervical Neoplasms; Papilloma; Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      The goal of the overall CASUS project is to develop the first fully molecular integrated
      cervical cancer screening approach, based on first-void urine as an easily accessible and
      non-invasive source of biomarkers. In contrast to current screening modalities, the CASUS
      approach will identify women with clinically relevant disease in need of treatment using only
      a single sample that can be collected at home (one-step triage).
    

Detailed description: 
      CASUS work package 4 (WP4):

      The main aim of this study is to validate the HPV-Risk assay (Self-screen, The Netherlands)
      followed by multiplex methylation specific quantitative PCR (qMSP, VU University Medical
      Center, The Netherlands) on first-void urine (Colli-Pee Small Volumes (10 mL) device,
      Novosanis, Belgium) of HPV positive women for detection of clinically relevant precursor
      lesions by sampling a cohort of women referred for colposcopy. The number of women in this
      cohort will allow us to clinically validate the use of the HPV-Risk/qMSP assay in DNA
      extracts of first-void samples after optimization of sample volume, internal process control,
      and DNA extraction method (Centre for the Evaluation of Vaccination, University of Antwerp,
      Belgium).
    

Intervention name(s): Colli-Pee Small Volumes (10 mL) device
Intervention type(s): Device
Intervention description(s): Women will self-collect two first-void urine samples at home the day prior to colposcopy using the new generation Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube will be prefilled with a non-toxic nucleic acid preservative including an internal process control.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Biomarker; First-void urine; Screening; Triage
Magnetotherapy in Rheumatoid Arthritis Treatment
Condition: Rheumatoid Arthritis; Hand Rheumatism
MeSH terms: Arthritis; Arthritis, Rheumatoid; Rheumatic Diseases
Study type: Interventional

Summary: 
      Participants with rheumatoid arthritis with recommendation to physiotherapy.

      Created 3 study groups:

        1. Only kinesiotherapy

        2. Kinesiotherapy with unipolar magnetic field

        3. Kinesiotherapy with bipolar magnetic field

      Kinesiotherapy with magnetic field give better effects than only kinesiotherapy.
    

Detailed description: 
      Participants with rheumatoid arthritis with recommendation to physiotherapy. All participants
      have dysfunction and pain of hand.

      Inclusion criteria:

        1. II ° and III ° of advancement of radiological changes

        2. II ° and III ° of advancement of functional changes

        3. Remission, low or moderate RA activity: DAS28

        4. Medical order

             1. Magnetotherapy and kinesiotherapy

             2. Kinesiotherapy

             3. Consent to participate in the study

             4. Completion of the research program

      Exclusion criteria:

        1. Additional physiotherapy treatments for the hands

        2. Change in type or dose of pharmacotherapy used

        3. Taking steroid anti-inflammatory drugs

        4. Malaise and side effects in the subject

      Outcome Measures:

        1. Duration of morning stiffness

        2. The degree of severity of morning stiffness

        3. Pain intensity assessment (VAS)

        4. Test Box & Blocks

        5. Measurement of the palmar surface of the hand

        6. Measuring the range of motion in the joints of the hand

        7. Measurement of compression force in a cylindrical grip

        8. Time to maintain maximum pressure during cylindrical grip

        9. Hand volume measurement

       10. HAQ-20 test

      Intervention:

        1. Group 1: Only kinesiotherapy

        2. Group 2: Kinesiotherapy with bipolar magnetic field

        3. Group 3: Kinesiotherapy with unipolar magnetic field

      Assessment:

        1. Immediately before start therapy

        2. Immediately after therapy (10 treatments in 2 weeks)
    

Intervention name(s): Kinesiotherapy with magnetotherapy
Intervention type(s): Other
Intervention description(s): Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 0-50 Hz, type of impulse: unipolar or bipolar, rectangular pulse
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Magnetotherapy; Rheumatoid arthritis; Hand function
Human Menopausal Gonadotropin (HMG) vs Recombinant Follicle Stimulating Hormone (rFSH) in Gonadotropin Releasing Hormone (GnRH) Antagonist Cycles
Condition: Ovarian Stimulation
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized controlled trial comparing the ongoing pregnancy rate (primary end-point) in 280
      patients undergoing IVF/ICSI after stimulation with hp-hMG or rFSH controlled with a GnRH
      antagonist. Non significant differences were observed between hp-hMG and rFSH in terms of the
      ongoing pregnancy rate per started cycle (35.0% vs. 32.1%; p=0.61); R.R: 1.09 (95% CI:
      0.78-1.51; Risk Difference: 2.9%). No differences were observed for implantation, clinical
      pregnancy and pregnancy loss rates. Patients receiving rFSH obtained more oocytes (14.4 ± 8.1
      vs. 11.3 ± 6.0; p=0.001). Estradiol was higher at the end of stimulation in the hp-hMG group,
      while Progesterone was higher in patients stimulated with rFSH.
    


Intervention name(s): Human Menopausal Gonadotropin (HMG) & - Recombinant Follicle Stimulating Hormone (r-FSH)
Intervention type(s): Drug
Intervention MeSH terms: Menotropins; Hormones; Follicle Stimulating Hormone
Keywords: Ongoing Pregnancy Rate
Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Dietary supplementation with soy may keep prostate cancer from growing in patients
      planning to undergo surgery.

      PURPOSE: This randomized phase II trial is studying a soy supplement to see how well it works
      compared to a placebo in treating patients undergoing surgery for localized prostate cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the effect of dietary supplementation with soy vs placebo on biomarkers of cell
           cycle regulation, proliferation, differentiation, apoptosis, and signaling pathways in
           patients with localized prostate cancer scheduled to undergo radical prostatectomy.

      Secondary

        -  Compare the toxicity and side effects of these regimens in these patients.

        -  Compare the dietary patterns of these patients.

      OUTLINE: This is a prospective, randomized study. Patients are randomized to 1 of 2 treatment
      arms.

        -  Arm I: Patients receive oral soy supplementation daily for 4 weeks.

        -  Arm II: Patients receive oral placebo supplementation daily for 4 weeks. Patients
           undergo radical prostatectomy within 21 days after completion of soy or placebo
           supplementation.

      Blood and tissue samples are collected for biomarker analysis using immunohistochemistry.
    

Intervention name(s): soy isoflavones; soy protein isolate; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Given orally; Given orally; Given orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer
Selegiline for Smoking Cessation - 1
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is designed to examine the effects of Selegiline Transdermal System
      and behavioral intervention in smoking cessation as compared to behavioral intervention
      alone.
    


Intervention name(s): Selegiline Transdermal Patch; Placebo; Smoking Cessation Counseling
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Selegiline cm(2) via transdermal system; Matching placebo via transdermal system; Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
Other intervention name(s): STS Patch; Placebo Patch
Intervention MeSH terms: Selegiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pharmacokinetic Profile of Inhaled Liposomal Amphotericin B in Lung Transplant Recipients - Ambisome Study
Condition: Lung Transplantation; Fungal Infections
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the steady state concentrations of inhaled
      liposomal amphotericin B (Ambisome®) in lung transplant recipients via aerosolized
      nebulization.
    

Detailed description: 
      Each subject will receive 1 mg/kg/day of inhaled Ambisome® for four days prior to the BAL
      (bronchoalveolar lavage) procedure. The dosage of 1 mg/kg was calculated by extrapolating the
      dosage of 1.6 mg/kg for the surface area of the rat lung to the human lung surface area in a
      60 kg individual.

      All four doses will be given in the presence of a physician and/or study coordinator. The
      forty eight subjects will be randomized such that six subjects undergo the BAL at 1, 12, 24,
      48, 72, 96, 120, and 168 hours after the last dose of inhaled Liposomal amphotericin B
      (AmBisome®).

      A blood sample (5 ml) will be obtained prior to the fourth dose of study medication and on
      the day of bronchoscopy (pseudo steady state trough). Concentrations of amphotericin in the
      serum, and bronchoalveolar lavage will be measured at pre-specified intervals after
      administration of liposomal amphotericin B (AmBisome®) in lung transplant recipients
      undergoing routine bronchoscopy as mentioned earlier.

      A 5 ml blood sample will be recovered at the time of bronchoscopy for the purpose of
      determination of serum amphotericin B concentration and for the determination of serum urea
      concentration.

      The bronchoscopy and bronchoalveolar lavage of subjects is done as a part of routine
      transplant care. Subjects will be followed for the follow-up of results of bronchoscopy at
      the interval deemed necessary by their transplant pulmonologist. The samples (blood and
      bronchoalveolar samples) will be under the control of the principal investigator of this
      research project. To protect confidentiality, all personal identifiers (i.e., name, social
      security number, and birth date) will be removed (de-identified) and replaced with a specific
      code number. The information linking these code numbers to the corresponding subjects'
      identities will be kept in a separate, secure location (ID lab at 8th floor Scaife Hall). The
      investigators on this study will keep the samples indefinitely. Samples may be given to
      investigators outside of UPMC or may be utilized in future studies about infectious diseases.
      If the samples are given to investigators not associated with this study, the samples will be
      provided without any identifiers. No genetic testing will be done on the samples obtained.
    

Intervention name(s): Amphotericin B
Intervention type(s): Drug
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Premeal Protein-bar on Glycemic Control in Patients With Type 2 Diabetes
Condition: Patients With Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of premeal protein-enriched bar in long-term
      glycemic control in patients with type 2 diabetes mellitus. Glucose levels in subjects who
      intake premeal protein-enriched bar with dietary modification will be compared to those in
      subjects who only do the dietary modification.
    

Detailed description: 
      Forty subjects with type 2 diabetes will be recruited. Every subject will be randomized in
      two groups, which are premeal protein bar with dietary modification group and dietary
      modification only group. The study will be conducted for 12 weeks for each participants. All
      participants will receive diabetes diet education. Intervention group will consume
      protein-enriched bar before each meals (at least twice a day) and control group will follow
      diabetes diet education without other additional supplements. Primary outcome is change of
      HbA1c from baseline for 12 weeks, and secondary outcomes are changes of fasting blood glucose
      level, body weight, waist circumference, blood lipid level, HOMA-IR and HOMA-beta from
      baseline for 12 weeks.
    

Intervention name(s): Premeal protein enriched bar; Dietary modification
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day).; Subjects in this group will follow diabetes diet education.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: protein-enriched bar; glycemic control; type 2 diabetes; long term
A Study to Investigate How JNJ-39758979 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of JNJ-39758979 on the pharmacokinetics
      (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis.
    

Detailed description: 
      This is an open-label (physician and participant will know the name of the assigned drug),
      multi-center, non-randomized, drug-drug interaction study of JNJ-39758979 in participants
      with rheumatoid arthritis (RA) on a stable oral methotrexate (MTX) dose (7.5 - 25 mg). The
      treatment phase will last 17 days. Participants will be housed in the clinic for dosing and
      study procedures from Day -1 to Day 3 and again from Day 13 to Day 17. Participants
      completing treatment will have a follow-up visit between Days 22 and 25. Participants who
      discontinue the study prematurely will complete the Day 22 to 25 follow-up procedures at the
      time of discontinuation or as soon as possible, thereafter. The length of participation in
      the study for an individual participant may be up to 9 weeks (including screening).
      Participant safety will be monitored. Day 1: A single oral dose of the participant's weekly
      methotrexate dose. Days 3-15: Weekly MTX co-administered with three 100-mg, enteric-coated
      tablets of JNJ-39758979, administered daily.
    

Intervention name(s): JNJ-39758979 / MTX
Intervention type(s): Drug
Intervention description(s): Day 1: MTX: Route=oral use, single dose of participant's weekly MTX dose; Days 3-15: MTX: Route=oral use, single dose of participant's weekly MTX dose and JNJ 39758979: Type=exact, unit=mg, number=300, form=tablet, route=oral use, administered daily.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; JNJ-39758979; Methotrexate
CDP323 Biomarker Study
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Comparison of the effects of different CDP323 doses given over a period of four weeks on
      blood biomarkers in subjects with relapsing forms of multiple sclerosis.
    


Intervention name(s): CDP323; CDP323; CDP323; CDP323; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 50mg capsules, 100mg bid for 4 weeks; 250mg capsules, 500mg bid for 4 weeks; 250mg capsules, 1000mg bid for 4 weeks; 250mg capsules, 1000mg daily for 4 weeks; placebo capsules for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: CDP323; Relapsing multiple sclerosis; Blood biomarkers