bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of the ALK Grass Tablet in Subjects With Hayfever
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is performed to assess the efficacy and safety of the ALK Grass tablet for
      treatment of grass pollen induced rhinoconjunctivitis (hayfever).
    


Intervention name(s): ALK Grass tablet
Intervention type(s): Biological
Intervention description(s): Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Grass pollen allergy; Hayfever; Allergen immunotherapy; Specific immunotherapy
A Study to Assess the Efficacy and Safety of Ganirelix (Orgalutran®) Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for in Vitro Fertilization (IVF) or Intra Cytoplasmatic Sperm Injection (ICSI) (Study 38651)(P05703)
Condition: Controlled Ovarian Stimulation
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to assess that ganirelix is safe and well-tolerated in
      Chinese women and that a controlled ovarian stimulation (COS) protocol combining recombinant
      follicle stimulating hormone (recFSH) with ganirelix is efficient in Chinese women undergoing
      COS for in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI).
    


Intervention name(s): ganirelix; triptorelin
Intervention type(s): Drug; Drug
Intervention description(s): On day 6 of recFSH treatment, Org 37462 treatment will start by daily SC administration (0.25 mg) up to and including the day of hCG administration.; a daily dose of 0.05 mg SC is to be injected. Triptorelin treatment will start in the luteal phase at day 21-24 of the menstrual cycle. Treatment with recFSH will start 14 days later if treatment with triptorelin has resulted in downregulation, i.e. serum E2 <= 50 pg/ml (<= 200pmol/l). In case the hypogonadotropic state is not reached after 14 days of pretreatment, the dose of triptorelin will be increased to 0.1 mg. If downregulation is not reached within 28 days of pre-treatment with triptorelin, the subject will be discontinued from further hormonal treatment. The daily dose of triptorelin is sustained up to and including the day of hCG.
Other intervention name(s): Orgalutran®; Org 37462; Decapeptyl
Intervention MeSH terms: Triptorelin Pamoate; Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Reproductive; techniques; assisted
EPO906 Therapy in Patients With Advanced Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine whether the investigational drug EPO906, given by intravenous
      infusion (IV directly into the vein), is effective in shrinking tumors and preventing the
      growth of cells that cause breast cancer.
    


Intervention name(s): epothilone b
Intervention type(s): Drug
Intervention MeSH terms: Epothilones; Epothilone B
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast; cancer; tumor; tumour; intravenous; epothilone; taxane; anthracycline
Protein Synthesis in Midthigh Muscles PET/CT
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Observational

Summary: 
      The purpose of this study is to test a new imaging technique to help scientists study
      sarcopenia, the process by which muscle becomes weaker with age.
    


Sampling method: Probability Sample
Study population: 
        healthy women
      
Keywords: study sarcopenia, which muscle becomes weaker with age
Relative Bioavailability and Food Effect Study of Losmapimod 15 mg Tablets
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to assess the relative bioavailability and the effect of food on the
      pharmacokinetics of a new 15 mg tablet formulation of losmapimod
    

Detailed description: 
      This study is a Phase 1, open-label, 3-period, 6-sequence, randomized, single-dose, crossover
      study designed to assess the relative bioavailability of a 15 mg tablet of losmapimod versus
      two 7.5 mg tablets of losmapimod under fasted conditions and to assess the effect of food on
      the pharmacokinetics of a 15 mg tablet of losmapimod under fasted and fed conditions in 18
      healthy subjects.

      The study will consist of a screening period, 3 treatment periods with a single dose of study
      drug per treatment period, a 48-hour washout period between dosing, and an end of study
      visit. Subjects will be randomly assigned to receive 1 of 6 treatment sequences (3 subjects
      per treatment sequence) prior to dosing on Day 1 of Period 1.

      The primary endpoint of the study is to assess the relative bioavailability and the effect of
      food on the pharmacokinetics of a new 15 mg tablet formulation of losmapimod. Secondary
      endpoints include assessing the safety and tolerability and evaluating target engagement in
      the blood of a new 15 mg tablet formulation of losmapimod in healthy subjects.
    

Intervention name(s): Losmapimod 15 mg oral tablet; Losmapimod two 7.5 mg oral tablets; Losmapimod one 15 mg oral tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive one losmapimod 15 mg tablet by mouth under fasted conditions.; Subjects will receive two losmapimod 7.5 mg tablets by mouth under fasted conditions.; Subjects will receive one losmapimod 15 mg tablet by mouth under fed conditions.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open-label, 3-period, 6-sequence, randomized, single-dose, crossover study designed to assess the relative bioavailability of a 15 mg tablet of losmapimod versus two 7.5 mg tablets of losmapimod under fasted conditions and to assess the effect of food on the pharmacokinetics of a 15 mg tablet of losmapimod under fasted and fed conditions
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Adult Subjects
Study to Assess the Acceptability/Swallowability of DRV-Containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets
Condition: HIV-1
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the acceptability of swallowing the
      darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide
      (D/C/F/TAF) fixed-dose combination (FDC) tablets, using matching placebo tablets, in human
      immunodeficiency virus (HIV) -1 infected adolescent patients.
    


Intervention name(s): DRV/COBI FDC placebo tablet; D/C/F/TAF FDC placebo tablets
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC; Participants will receive 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the administration of N-Acetyl-cysteine in combination with
      multi-vitamins/minerals in geriatric population (>60 years of age) who have experienced a
      traumatic brain injury.
    

Detailed description: 
      This study aims to determine the effect of supplemental N-acetyl cysteine and additional
      multi-vitamin/mineral therapy on somatic, cognitive, and emotional post-concussion symptoms
      as determined by the Rivermeade Post-concussion Questionnaire (RPQ) within 24 hours of
      admission, post injury day 7, and post injury day 30. The RPQ questionnaires will be given to
      patients older than 60 years, who have been evaluated by the HonorHealth John C. Lincoln
      Medical Center or Deer Valley Medical Center trauma service within 3 hours of sustaining a
      traumatic brain injury (TBI).
    

Intervention name(s): N-Acetyl cysteine
Intervention type(s): Drug
Intervention description(s): Carbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI
Other intervention name(s): Multi-vitamins with minerals
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
High-intensity Training for Improving Physical Performance of Aged Women
Condition: Aging; Healthy; Cardiovascular Risk Factor; Physical Activity
Study type: Interventional

Summary: 
      This study evaluates the adaptations on the functional capacity and cardiovascular in elderly
      after a physical activity program circuit training. The participants were divided into three
      groups: Circuit training based on high-intensity interval training group (HIICT), Circuit
      training at moderate intensity group (MICT) and Control group (CG).
    

Detailed description: 
      Three groups of participants (circuit training based on high-intensity interval training,
      circuit training at moderate intensity and not training group) will enter the study. The
      intervention will consist of a physical exercise program in day centers.

      Intensity progression will be encouraged according to the rate of perceived exertion.
      Progression of exertion will be "very hard", "extremely hard" and "maximal exertion" for HIT
      group, and "light", "somewhat hard" and "hard" for group. Assessment will be undertaken at
      two-time points: baseline and after 16 weeks of exercise training.

      Assessment will include VO2 peak, functional capacity, health-related quality of life,
      cognitive state and daily physical activity.
    

Intervention name(s): Experimental: High-intensity interval training group; Experimental: Moderate-intensity interval training group
Intervention type(s): Other; Other
Intervention description(s): 16 weeks of High-intensity interval training; 16 weeks of Moderate-intensity interval training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: HIT; MIT; GC
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: High-intensity interval training; Circuit training; Elderly; Functional capacity; VO2 max; Cardiovascular parameters
Percutaneous Electrolysis Versus Dry Needling in Levator Scapulae
Condition: Trigger Point Pain, Myofascial; Myofascial Pain
MeSH terms: Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The objective will be to determine the effectiveness of ultrasound-guided percutaneous
      electrolysis versus ultrasound-guided dry needling in active myofascial trigger points of the
      levator scapulae muscle on pain intensity, disability and range of motion. A randomized
      clinical trial will be carried out. Fifty-four patients with at least one active myofascial
      trigger point in the levator scapulae muscle were recruited and divided into
      ultrasound-guided percutaneous electrolysis (n = 27) and ultrasound-guided dry needling
      (n=27). Pain intensity, disability and range of motion will measured before, immediately
      after and 1 week after intervention.
    


Intervention name(s): Percutaneous electrolysis; Dry needling
Intervention type(s): Other; Other
Intervention description(s): Ultrasound-guided percutaneous electrolysis in the active myofascial trigger point of the levator scapulae muscle; Ultrasound-guided dry needling the active myofascial trigger point of the levator scapulae muscle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of Targeted Lower Extremity Joint Training on Multiple Sclerosis (MS) Gait Abnormalities
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Congenital Abnormalities; Sclerosis
Study type: Interventional

Summary: 
      This study is being done to test the possible benefits of task-specific focused ankle
      training using the Ankle-Bot on subjects with Multiple Sclerosis who have "foot-drop." The
      study also compares the effectiveness of task-specific focused ankle training using the
      Ankle-Bot with conventional focused ankle therapy in improving the gait of subjects with MS.
    


Intervention name(s): Ankle-bot; Conventional focused ankle therapy
Intervention type(s): Device; Other
Intervention description(s): The Ankle-bot is a piece of robotic therapy equipment for the ankle. In this study, it will be used to guide and assist the subject into ankle flexion, extension, inversion and eversion.; Conventional focused ankle therapy will be performed by a physical therapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Gait; foot-drop; Ankle-Bot; Physical Therapy; Gait Abnormalities
A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      A study of the safety and efficacy of infliximab (Remicade) in pediatric patients with
      moderate to severe Crohn's Disease
    

Detailed description: 
      This is a medical research study to evaluate the safety and effectiveness of an antibody
      called infliximab (Remicade) in the treatment of children with Crohn's disease. In this
      study, subjects will receive multiple doses of infliximab over 62 weeks. The goal of the
      study is to ensure that the medication is safe and effective in children when it is given for
      an extended period of time. All subjects will receive an induction regimen of 5 mg/kg
      infliximab at Weeks 0, 2, and 6. Subjects will then receive either 5 or 10 mg/kg infliximab
      either every 8 or 12 weeks for up to 46 weeks followed by an open label extension for up to
      three additional years.
    

Intervention name(s): infliximab
Intervention type(s): Drug
Intervention MeSH terms: Infliximab
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Crohn's Disease; pediatric Crohn's Disease
Genistein in Preventing Breast or Endometrial Cancer in Healthy Postmenopausal Women
Condition: Breast Cancer; Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. The use of genistein may be effective in preventing
      breast or endometrial cancer.

      PURPOSE: This randomized phase I trial is studying the effectiveness of genistein in
      preventing breast or endometrial cancer in healthy postmenopausal women.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the effects of genistein vs placebo on DNA damage and apoptosis by conducting
           COMET, TUNEL, Caspase-3, and AP site assays in healthy postmenopausal women.

        -  Compare the effects of these drugs on gene expression in an estrogen-sensitive tissue by
           oligoarray profiling in these participants.

        -  Determine the effect of genistein on estrogenic effects by self-reported side effects,
           measurement of sex hormone-binding globulin, follicle-stimulating hormone, luteinizing
           hormone, and estrogen levels, and expression of known estrogen-sensitive genes in these
           participants.

      OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are
      stratified according to their study ID numbers. Participants are randomized to 1 of 2
      treatment arms.

        -  Arm I: Participants receive oral genistein twice daily on days 1-84.

        -  Arm II: Participants receive oral placebo twice daily on days 1-84. In both arms,
           treatment continues in the absence of dysplasia, malignancy, unacceptable toxicity, or
           gross noncompliance.

      Participants are followed at days 7, 14, 28, 56, and 84 during study treatment and at day 28
      after completion of study treatment.

      PROJECTED ACCRUAL: A total of 30 participants (20 for arm I and 10 for arm II) will be
      accrued for this study.
    

Intervention name(s): Genistein; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): oral Genistein twice daily on days 1-84; oral Placebo twice daily on days 1-84
Other intervention name(s): PTI G-2535
Intervention MeSH terms: Genistein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: breast cancer; endometrial cancer
Genetic Studies Spermatogenic Failure
Condition: Oligospermia; Azoospermia; Male Infertility
MeSH terms: Infertility; Infertility, Male; Azoospermia; Oligospermia
Study type: Observational

Summary: 
      The proposed study is designed to test the following hypotheses:

        1. Mouse autosomal or X-linked genes which are exclusively expressed in mouse spermatogonia
           are also spermatogonia-specific in human.

        2. Severe spermatogenic defect, especially hypospermatogenesis or SCOS, is caused by an
           intrinsic defect in germ line stem cell or speramtogenia.

        3. Spermatogonia-specific genes are caudate genes for human spermatogenic defect,
           especially for hypospermatogenesis or SCOS.

        4. For a significant fraction of cases with severe spermatogenic defect, the sterile genes
           are transmitted via multifactorial inheritance mode.

        5. For some cases with severe spermatogenic defect, mutations of spermatogonia- specific
           genes may be transmitted in the X-linked recessive, autosomal recessive, or autosomal
           dominant mode.
    

Detailed description: 
      Between 2% and 12% of couples worldwide are affected by reduced fertility. Men who have
      defects in sperm production (spermatogenic defect) account for about half of these cases. In
      Drosophila and mouse, targeted disruptions of numerous sterility- associated genes have been
      created. Physiological studies in the Drosophila and in mouse also indicate that
      spermatogenesis is subjected to complex regulation, and male infertility may result from
      aberrant regulatory events. In the human being, deletions of the Y chromosome account for
      only 10% of cases with spermatogenic defect, and etiologies of remaining 90% of cases are
      still unknown. It is evident that multiple genes are involved in male infertility. For cases
      with severe spermatogenic defect , testicular histology shows either decreased number of germ
      cells in all developmental stages (hypospermatogenesis) or complete absence of germ cells
      (Sertoli cell only syndrome or SCOS). It appears that there is an intrinsic defect which
      causes depletion of germ-line stem cells (spermatogonia) for cases with hypospermatogenesis
      or SCOS. Of 25 genes exclusively expressed in mouse spermatogonia, 3 are Y-linked, 10 are
      X-linked, and only 12 are distributed on autosomes.
    

Intervention name(s): Drawing blood to study genetic polymorphism
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient visited our outpatient clinic
      
Biospecimen description: 
      whole blood
    
Keywords: spermatogenesis defect; male infertility; azoospermia; oligozoospermia; Y chromosome markers; estrogen gene
Propofol and Perioperative Inflammation
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The inflammatory properties of propofol are still under debate. Apolipoprotein A-I (Apo A-I)
      is involved in the inflammatory process. This study was designed to determine whether and how
      propofol or its solvent modulate Apo A-I and the inflammatory response after surgical stress.
      The investigators study hypothesis was that propofol might modify the Apo A-I blood levels,
      and thus, modulate the postoperative inflammatory course.
    


Intervention name(s): propofol; Intralipid 10%; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Induction with propofol (1.5 to 2mg/kg) and maintenance of anesthesia with propofol 1% (target controlled infusion with concentration levels of 3-5 ug/ml); Induction of anesthesia with thiopental (3-5mg/kg) and maintenance of anesthesia with isoflurane (end-expired concentration = 0.5%-2.0%) as well as the solvent of propofol 1% (Intralipid 10%; corresponding to a target-controlled infusion of propofol with concentration levels of 3-5ug/ml); Induction of anesthesia with thiopental (3-5mg/kg) and maintenance of anesthesia with isoflurane (end-expired concentration = 0.5%-2.0%)
Other intervention name(s): Propofol, Ansiven; Intralipid; NaCl 0.9%
Intervention MeSH terms: Propofol; Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: propofol; inflammation; perioperative; lipids; Apolipoprotein A-I
A Study of Tirzepatide (LY3298176) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has four parts. Each participant will enroll in one part.

      Part A: The purpose of Part A is to compare study drug tirzepatide solution formulation to a
      powder formulation mixed with water and given subcutaneously (SC) (just under the skin). Part
      A will measure how much of the study drug gets into the blood stream and how long it takes
      the body to get rid of it.

      Part B: The purpose of Part B is to evaluate the safety and tolerability of tirzepatide
      intravenous (IV) formulation when administered into a vein.

      Part C: The purpose of Part C is to evaluate the safety and tolerability of tirzepatide
      following multiple SC weekly doses of a solution.

      Part D: The purpose of Part D is to evaluate the safety and tolerability of tirzepatide
      following single IV bolus dose of lyophilized formulation.

      This study will last approximately 70 days for each part (Part A, Part B or Part D) and 92
      days for Part C. This does not include screening. Screening is required within 28 days prior
      to the start of the study.
    


Intervention name(s): Tirzepatide; Tirzepatide; Placebo; Tirzepatide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered SC; Administered IV; Administered SC; Administered IV
Other intervention name(s): LY3298176; LY3298176; LY3298176
Intervention MeSH terms: Tirzepatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science