bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of Fostamatinib Tablets to Treat B-cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Patients: B-cell lymphoma, refractory, diffuse, nodular, mantle, other Phase I : Two groups
      of 6 patients, escalating dose tolerability- 28 days Phase II: Three groups of 16 patients
      (nodular, diffuse large cell, mantle cell plus others). Oral bid dosing with highest
      tolerable dose until toxicity, progression, or withdrawal
    

Detailed description: 
      This multicenter, open-label study of fostamatinib will take place in two phases.

      Phase I Two cohorts, of 6 patients each, will be sequentially assigned to receive 200 mg
      (Cohort 1) and 250 mg (Cohort 2) PO bid of R788. Patients will be enrolled at 250 mg bid in
      Cohort 2 only if < 1/6 patients in Cohort 1 experience dose-limiting toxicity (DLT) during
      the initial 28-day treatment period. If 2 or more patients in Cohort 1 experience DLT during
      the initial 28-day treatment period, patients in Cohort 2 will receive 150 mg PO bid.

      Patients who do not experience DLT or disease progression may continue treatment at the
      assigned dose level until disease progression, toxicity or withdrawal. Patients who
      experience DLT may resume treatment at a lower dose level (dose will be decreased by 50 mg)
      when the toxicity grade has decreased to ≤ 1. Once all patients in Phase I have completed 28
      days of treatment, the optimal dose of fostamatinib, based on safety and anti-tumor activity,
      will be determined.

      Phase II 48 additional patients, 3 groups of 16 patients each, will receive fostamatinib at
      the optimal biologic dose PO bid until tumor progression, limiting toxicity or withdrawal.
      Group 1 will consist of patients with diffuse large B-cell lymphoma (DLBCL), Group 2 will
      consist of patients with follicular lymphoma, and Group 3 will consist of patients with
      mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone
      lymphomas, small lymphocytic lymphomas (SLL), and chronic lymphocytic leukemia (CLL).
    

Intervention name(s): fostamatinib
Intervention type(s): Drug
Intervention description(s): 200 mg PO BID
Other intervention name(s): R935788, R788, fostamatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DLCL; Nodular lymphoma; Mantle cell lymphoma; Syk kinase
Erinacine A-enriched Hericium Erinaceus Mycelia for Improvement of Recognition, Vision, and Functional MRI Alterations
Condition: Supplement; Cognition Disorders in Old Age; Vision; fMRI
MeSH terms: Cognition Disorders
Study type: Interventional

Summary: 
      This study was designed as randomized double blind placebo study to investigate the efficacy
      of Erinacine A-enriched Hericium erinaceus mycelia for improvement of recognition, vision,
      and functional MRI alterations.
    

Detailed description: 
      Patients were recruited with diagnosis of mild or medium dementia, according to criteria by
      NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and
      Stroke-Alzheimer's Disease and Related Disorders Association) as probable or possible
      Alzheimer's disease. Upon signature of informed consent, they were subject to: (1) Cognitive
      assessments, including Mini-Mental State Examination(MMSE), Neuropsychiatric Inventory (NPI),
      Cognitive Abilities Screening Instrument (CASI), and Instrumental Activities of Daily Living
      (IADL) on weeks 0, 12, 24, and 49, (2) Blood Markers Tests, including DHEAS, Alpha
      1-antichymotrypsin, Superoxide Dismutase, and Homocysteine, Apolipoprotein E, Hemoglobin,
      Calcium, Albumin, and Amyloid Beta on weeks 0, 24, and 49, (3) fMRI Assessments for
      Super-resolution Track Density Imaging (TDI), and Blood Oxygenation Level-Dependent (BOLD)
      Signal Mapping, on weeks 0 and 49, (4) Vision Assessments, including Visual Acuity (VA) and
      Contrast Sensitivity (CS), on weeks 0, 24, and 49. Mann-Whitney U test and Wilcoxon tests
      were applied to examine the data before and after dietary intake of Erinacine A-enriched
      Hericium Erinaceus Mycelia after 49 weeks.
    

Intervention name(s): Erinacine A-enriched Hericium Erinaceus Mycelia; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Placebo supplement was given to the participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Double Blinded placebo study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Erinacine A, supplement, Alzheimer's disease
Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor
Condition: Preeclampsia Severe
MeSH terms: Pre-Eclampsia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to
      placebo in 110 patients after decision has been made to proceed with induction of labor for
      the diagnosis of preeclampsia with severe features.
    

Detailed description: 
      This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to
      placebo in 110 patients after decision has been made to proceed with induction of labor for
      the diagnosis of preeclampsia with severe features.

      After diagnosis of preeclampsia with severe features and decision made to proceed with
      induction of labor. Patients were approached about study and if consented then were then
      randomized to placebo or nifedipine 30XL daily until delivery occurred.
    

Intervention name(s): Nifedipine 30 MG; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Nifedipine XL is a long-acting medication used to lower blood pressure. The investigators want to learn whether women who receive the study drug will experience fewer severe-range blood pressure readings, and therefore need fewer intravenous (IV) medications to safely lower blood pressure.; At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo.
Intervention MeSH terms: Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are enrolled and randomly selected to receive Nifedipine or placebo through delivery of her infant.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: preeclampsia severe, Nifedipine 30MG, placebo controlled
Early Intervention in Allergic Patients
Condition: Allergic Rhinitis Due to Weed Pollen; Montelukast
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      As many as 250 million people suffer from allergic rhinitis in China, which has a large
      population, early use of drugs may help better control the symptoms.This study aimed to
      investigate the effects of early interventional treatment with the leukotriene receptor
      antagonist (LTRA) montelukast on seasonal allergic rhinitis.
    


Intervention name(s): Start taking Montelukast Sodium Tablets 10mg quaque die orally two weeks before peak pollen count.; Montelukast Sodium Tablets 10mg quaque die orally was administered after peak pollen count.; No oral drug therapy throughout the pollen period
Intervention type(s): Behavioral; Behavioral; Drug
Intervention description(s): Start taking Montelukast Sodium Tablets 10mg quaque die orally two weeks before peak pollen count.Intranasal corticosteroids (mometasone furoate) 100μg was used in the group after peak pollen count.; 10mg quaque die orally was administered after peak pollen count.Intranasal corticosteroids (mometasone furoate) 100μg was used in the group after peak pollen count.; Intranasal corticosteroids (mometasone furoate) 100μg was used in the group after peak pollen count.
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma
Condition: Trachoma
MeSH terms: Trachoma
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess in children the efficacy and safety of 2 dosing regimens of T1225 1.5% eye drops,
      in comparison to a reference product, single-dose oral azithromycin (AZM) 20 mg/kg, for the
      treatment of active trachoma. Evaluation of clinical efficacy was primary (% of clinical cure
      at Day 60 in Per Protocol Set), microbiological evaluation was secondary
    

Detailed description: 
      The aim of the present study was to compare the efficacy of the dosing regimen which was
      demonstrated in pharmacokinetic studies to be the best candidate for trachoma treatment
      (T1225 1.5% eye drops BID for 3 days) with a shorter duration of treatment (T1225 1.5% eye
      drops BID for 2 days) and with a single oral administration of AZM (20 mg/kg) in patients
      suffering from active trachoma. The study was to be performed in approximately 600 children
      (aged 1 to 10 years) from Guinea Conakry and Pakistan.
    

Intervention name(s): Azithromycin
Intervention type(s): Drug
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, multi-center, randomized, double-blind, placebo-controlled study in adult
      participants with peanut allergy. Participants will be randomized in a 3:1 ratio to receive
      either an escalating dose of INT301 or placebo. The treatment group will be blinded to the
      investigator, participants, and the Intrommune study team.
    


Intervention name(s): INT301; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): INT301 is an allergy immunotherapy delivered in the form of a fully functional toothpaste; Fully functional toothpaste containing no immunotherapy agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peanut allergy; Food allergy; Desensitization; Allergy Immunotherapy; OMIT; OIT; EPIT; SLIT; Oral Mucosal Immunotherapy
Bedsider.Org in Post-abortion Contraceptive Counseling: A Mixed Methods Study
Condition: Contraception
Study type: Interventional

Summary: 
      This is a mixed methods study, incorporating a randomized controlled trial and a qualitative
      provider focus group, to evaluate contraceptive counseling aided by www.Bedsider.org in
      patients seeking first-trimester abortion. The primary outcome is the uptake of long-acting
      reversible contraception in women seeking induced abortion.
    

Detailed description: 
      Nearly half of pregnancies among American women are unintended, and about 4 in 10 of these
      are terminated by abortion. Unmet need for family planning is the cause for induced abortion,
      and those women seeking induced abortion are a high risk for repeat abortion. Family planning
      services are of paramount importance to this population, and evidence shows that high-quality
      family planning counseling and provision of methods prior to discharge from a care facility
      improve uptake and continuation of methods. In a recent study, oral contraceptive pills, a
      transdermal patch, or a vaginal ring had a risk of contraceptive failure that was 20 times as
      high as the risk among those using long-acting reversible contraception (IUD or implant).

      We plan to randomize preoperative clinic days to either provider counseling aided by
      Bedsider.org or routine provider counseling, and compare the types of contraceptive methods
      that are chosen in each group, with the primary outcome being uptake of long-acting
      reversible contraception (intrauterine device or implant). The secondary outcome is
      satisfaction with contraceptive counseling in both groups.

      We also plan to conduct a qualitative focus group study of provider perspectives of this
      counseling tool after completion of the randomized trial. Materials related to the
      qualitative portion of the study will be submitted in a separate amendment. No Follow-up is
      needed.

      EXPECTED OUTCOMES AND DISSEMINATION OF FINDINGS The goal of the study is to assess the
      feasibility and effectiveness of using a web-based contraception tool in a unique family
      planning clinic serving high-risk patients with expert family planning providers. After
      assessing feasibility, utility, and effectiveness in our practice setting, we hope to spread
      the use of bedsider.org to the entirety of the outpatient clinic, which includes general
      obstetrics and gynecology patients and providers.

      After completion of the study, we plan to submit our findings for presentation at a national
      meeting, and submit a manuscript for publication in a peer-reviewed journal.
    

Intervention name(s): Bedsider.org counseling
Intervention type(s): Behavioral
Intervention description(s): Contraceptive counseling was done while women kept the computer/tablet throughout their visit to facilitate discussion of website information with their providers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Plasma Adiponectin Level and Vascular Endothelial and Smooth Muscle Cell Function in Children With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome; Obesity
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Observational

Summary: 
      Context: Prader-Willi syndrome (PWS) is a genetic disorder characterized by childhood-onset
      obesity and endocrine dysfunction that leads to cardiovascular disability and early death
      within the first 3 decades of life.

      Objectives: To assess the significance of risk factors for future disabilities, carotid
      artery intima-media thickness (IMT) was measured and correlated with known atherosclerotic
      risk factors in 27 children with PWS and 24 age-, sex-, and body mass index (BMI)-adjusted
      controls.
    

Detailed description: 
      Main outcome measures: Correlation of IMT with age, standard deviation score of BMI
      (BMI-SDS), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol
      (LDL), C-reactive protein, HOMA-IR and ghrelin.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The investigators studied twenty-seven children with PWS and 24 normal control subjects.
        The groups were adjusted for age, sex, and BMI.
      
Keywords: Intima-media thickness; Ghrelin; Prader-Willi syndrome
Effects of Combined Cognitive Rehabilitation in COPD Patients
Condition: COPD
Study type: Interventional

Summary: 
      This study was to examine the effect of endurance training combined with cognitive training
      in patients with COPD. The intervention group underwent Cognitive Training added to Endurance
      Training and the control group underwent only Endurance Training.
    

Detailed description: 
      Pulmonary rehabilitation is an essential part of the management of COPD. Although various
      methods and therapies of PR have been used in COPD patients. Furthermore, the Cognitive
      Training has been performed people with mild cognitive impairments.

      Therefore, the combination of endurance training and cognitive tarining could be another
      alternative to improve the exercise tolerance and cognitive function in patients with COPD.
      It may also be useful for clinicians interested in designing new rehabilitation therapies.
      The aim of the study was to analyze the effect of CT combined with ET on exercise tolerance
      and cognitive functions in COPD patient.
    

Intervention name(s): clinical trials
Intervention type(s): Other
Intervention description(s): examined two type of training on cognitive parameters for COPD patients
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: COPD; cognitive training; cognitive impairment; P300 test; MOCA
Naltrexone in the Treatment of Trichotillomania
Condition: Trichotillomania
MeSH terms: Trichotillomania
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania
    

Detailed description: 
      The goal of the proposed study is to evaluate the efficacy of Naltrexone in trichotillomania.
      Forty subjects with DSM-IV trichotillomania will receive 8 weeks of double-blind Naltrexone
      or placebo. The hypothesis to be tested is that Naltrexone will be effective and well
      tolerated in patients with trichotillomania compared to placebo. The proposed study will
      provide needed data on the treatment of a disabling disorder that currently lacks a clearly
      effective treatment.
    

Intervention name(s): Naltrexone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): pill, by mouth, 50mg-150mg/day for the duration of the study; pill, by mouth, daily
Other intervention name(s): ReVia; also known as a 'sugar pill'
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hair pulling
Effect of Stabilization Shoes on Balance in Elderly
Condition: Elderly
Study type: Interventional

Summary: 
      Movement during everyday activities most often requires stable posture. Postural control
      corresponds to a complex motor ability to maintain / re-establish balance and orient one's
      body in the environment. Postural stability and equilibrium deteriorate with age. More than
      30% of people over 65 years old fall per year. Falls represent 90% of hip fractures and
      sometimes result in lasting psychological effects. Shoes are our direct link between the
      ground and our feet. Wearing shoes plays a major role in postural control. The
      characteristics of shoes usually worn by elderly people are identified with those of shoes
      known to be 'dangerous'. In order to improve stability and reduce the risk of falling for the
      elderly, Axis-Comfort Development® has developed "experimental balance shoes". Their shoes
      have technical characteristics presented in the scientific literature as beneficial for
      postural stability.

      Therefore, the aim of this study was to investigate the effects of wearing experimental
      balance shoes on postural balance compared with the people's own shoes. We assumed that
      postural balance would be improved by experimental balance shoes in an acute way and improved
      by a familiarization phase.

      This was a controlled, randomized, blind and cross-over study. three sessions were held in
      our center, each time interspersed with a phase of familiarization at home (7 to 10 days)
      during which the people had to wear either the experimental balance shoes or their own
      personal shoes. 21 volunteers in total participated in this study, all between 65 and 75
      years old. Five tests were presented randomly for each session and all tests were carried out
      on a Huber 360 ® (LPG System, France) stabilometric platform. The mains criteria were static
      equilibrium on one foot and two feet (with eyes open and closed) and secondary criteria were
      stride frequency during the walk on the spot and stability limits.

      An improvement of these multiple criteria during the different sessions would be proof of the
      positive effect of experimental balance shoes on postural balance in the elderly.
    


Intervention name(s): Balance Shoe; Personal Shoe
Intervention type(s): Device; Device
Intervention description(s): Use of experimental balance shoes for carrying out the tests along the three sessions and one of the two familiarization phases; Use of Personal shoes (the same for each session) for carrying out the tests along the three sessions and one of the two familiarization phases
Other intervention name(s): Axis Comfort Development® Experimental Balance shoes; Own personal shoes of subjects
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Postural Balance; Accidental Falls; Footwear; Stability; Force platform; Unipedal stance; Bipedal stance; Shoe
A Study to Evaluate Absorption, Metabolism, and Excretion of 14C-JNJ26489112 in Healthy Male Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the absorption, the metabolic pathways (a series of
      metabolic reactions) and the excretion of JNJ26489112 in healthy male adult participants
      after administration of a single oral dose of 1000 mg of 14C-JNJ26489112.
    

Detailed description: 
      This is a single-dose, 1-arm (group), open-label study (all people know the identity of the
      intervention) in healthy adult male participants. On Day 1, after completing a 10-hour
      overnight fast, participants will receive a single oral dose of 14C-JNJ-26489112 1,000 mg as
      a 10-mL suspension. Participants will be recruited in 2 cohorts. The 6 participants in the
      first cohort were dosed in error with doses less than 1000 mg. So, an additional cohort of 4
      participants will be enrolled to receive a single oral dose of 1000 mg 14C-JNJ 26489112.
      Total 10 participants will receive the study medication. Safety will be assessed by
      monitoring vital signs, physical examinations, electrocardiograms, and clinical laboratory
      tests throughout the study. The total duration of the study for each participant will be
      approximately 5 weeks (including up to 3 weeks for screening and 11 to 15 days of study) or
      up to 1 additional week for participants who excrete 14C-JNJ26489112 more slowly.
    

Intervention name(s): 14C-JNJ26489112
Intervention type(s): Drug
Intervention description(s): Participants will receive single dose of oral suspension of 1000 mg (10 mL) of 14C-JNJ26489112 on Day 1.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Participants; JNJ26489112; 14C-JNJ26489112; Absorption; Metabolism; Excretion