bioihbjkbjnl/mcl2 huggingface dataset:
Multiple Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      BMS-820132 is an investigational new drug being developed by BMS for treating Type 2
      diabetes. The purpose of this study is to test the safety/tolerability (potential side
      effects) of multiple doses of the investigational new drug, as well as the amount of study
      drug in the blood and its effects on blood sugar,in subjects with type 2 diabetes.
    

Detailed description: 
      Study Classification: Safety, Pharmacokinetics/dynamics
    

Intervention name(s): Placebo; Placebo; BMS-820132; BMS-820132; BMS-820132; BMS-820132; BMS-820132; BMS-820132; BMS-820132
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): capsule, Oral, 0.0mg, twice daily, 14 day; Capsule, Oral, 0.0mg, once daily, 14 day; Capsule, Oral, 15mg, twice daily, 14 day; Capsule, Oral, 60mg, twice daily, 14 day; Capsule, oral, 150mg, twice daily, 14 day; Capsule, Oral, 300mg, twice daily, 14 day; Capsule, Oral, 450mg, twice daily, 14 day; Capsule, Oral, To be determined (TBD), once daily, 14 day; Capsule, Oral, 5 mg, twice daily, 14 day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis
Condition: Adenomyosis
MeSH terms: Adenomyosis
Study type: Interventional

Summary: 
      Objective: To investigate the effects of levonorgestrel-releasing intrauterine system
      (LNG-IUS) for symptomatic adenomyosis.

      Methods: From December, 2006 to December, 2014, symptomatic patients of adenomyosis diagnosed
      (with dysmenorrhea and/or menorrhea) by transvaginal ultrasound in outpatient or inpatient
      clinics of Peking Union Medical College Hospital were given the treatment of LNG-IUS. Before
      and after placement of LNG-IUS, during each following period, all the parameters were
      recorded prospectively, including carrying status of IUS, symptoms and scores of
      dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation
      patterns and adverse effects.

      Primary outcome measures: symptoms and scores of dysmenorrhea and menorrhea

      Second outcome measures: carrying status of IUS
    


Intervention name(s): Placement of levonorgestrel-releasing intrauterine system
Intervention type(s): Procedure
Intervention description(s): All the patients accepted treatment of levonorgestrel-releasing intrauterine system
Intervention MeSH terms: Levonorgestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: levonorgestrel-releasing intrauterine system; adenomyosis
Effect of Addition of Aromatase Inhibitor to Ovarian Stimulation Therapy in IVF Treatment
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This project seeks to determine whether estradiol suppression achieved with adjuvant
      treatment with an aromatase inhibitor improves end-follicular and midluteal phase parameters
      during IVF. 128 patients will be randomized to either placebo or active treatment.
    

Detailed description: 
      The aim of the study is to investigate whether the detrimental effects of ovarian stimulation
      on outcomes in fresh embryo transfer cycles be ameliorated by co-treatment with aromatase
      inhibitors? The research questions are:

        1. Can the impact of ovarian stimulation on late follicular phase sex steroid levels (and
           hence endometrial receptivity) be mitigated by co-treatment with aromatase inhibitors
           during ovarian stimulation?

        2. Does co-treatment with aromatase inhibitors 'normalize' the endocrinology of the
           midluteal phase
    

Intervention name(s): Letrozole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Adjuvant therapy to recFSH during ovarian stimulation; Adjuvant therapy to recFSH during ovarian stimulation
Other intervention name(s): Aromatase Inhibitor; Lactose Monohydrate
Intervention MeSH terms: Letrozole; Aromatase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI)
Condition: Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of a drug known as CS-747 (also known as
      prasugrel) on subjects having a procedure called a percutaneous coronary intervention (also
      referred to as PCI) in which a doctor will attempt to open a blocked vessel (or vessels) in
      the heart using a catheter (a long thin tube) that has a small balloon on the end. In many
      cases, patients who have this procedure receive a stent, a small wire spring that helps keep
      the vessel open.
    


Intervention name(s): Prasugrel (CS-747); Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): Prasugrel; LY640315; Effient; Efient
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Determine the Safety and Efficacy of LX3305 in Subjects With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the safety of LX3305 in a dose escalation
      compared with placebo over 12 weeks in subjects with active rheumatoid arthritis (RA).
    


Intervention name(s): 50 mg LX3305 QD; 100 mg LX3305 QD; 150 mg LX3305 QD; 200 mg LX3305 QD; 250 mg LX3305 QD; 300 mg LX3305 QD; 400 mg LX3305 QD; 250 mg LX3305 BID; 500 mg LX3305 QD; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 50 mg LX3305 once daily in capsule form; 100 mg LX3305 once daily in capsule form; 150 mg LX3305 once daily in capsule form; 200 mg LX3305 once daily in capsule form; 250 mg LX3305 once daily in capsule form; 300 mg LX3305 once daily in capsule form; 400 mg LX3305 once daily in capsule form; 250 mg LX3305 twice daily in capsule form; 500 mg LX3305 once daily in capsule form; Matching placebo dosing in capsule form
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women
Condition: Vasomotor Symptoms; Hot Flushes
MeSH terms: Flushing; Hot Flashes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this Phase III trial is to evaluate the efficacy of oral administration of
      dehydroepiandrosterone (DHEA) combined with acolbifene (a selective estrogen receptor
      modulator (SERM)) on vasomotor symptoms (hot flushes) in postmenopausal women.
    


Intervention name(s): Placebo; DHEA and Acolbifene
Intervention type(s): Drug; Drug
Intervention description(s): Placebo DHEA capsules (2) + placebo acolbifene capsule (1); daily oral dosing for 12 weeks.; DHEA capsules (2 x 50 mg) + acolbifene capsule (1 x 20 mg); daily oral dosing for 12 weeks.
Other intervention name(s): Prasterone; dehydroepiandrosterone; EM-652.HCl
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hot flush(es); Hot flash(es); Vasomotor symptoms; Dehydroepiandrosterone (DHEA); Prasterone; Acolbifene; Selective estrogen receptor modulator (SERM); Antiestrogen; Menopause; Postmenopausal women
PBMT on Muscular Performance and Recovery in Different Time-points
Condition: Phototherapy
Study type: Interventional

Summary: 
      Recent studies with photobiomodulation therapy (PBMT) have shown positive results delaying
      skeletal muscle fatigue and improving the status of biochemical markers related to skeletal
      muscle damage when these therapies were applied before exercise. The aim of this project is
      to verify the effects of PBMT in improvement of skeletal muscle performance and skeletal
      muscle recovery in healthy male subjects. This project aim also to validate the concept that
      simultaneous use of three wavelengths and light sources lead to optimized action
      independently of time-window between irradiation and the exercise.
    

Detailed description: 
      This is a randomized, triple-blinded, placebo-controlled trial. Sixty healthy untrained male
      subjects will be randomly allocated to six experimental groups: Placebo, Control, PBMT 5
      mins, PBMT 3h, PBMT 6h and PBMT 24 hours. PBMT will be applied precisely two minutes after
      baseline MVC test. Then, after five minutes, 3, 6 hours or 1 day (24 hours) of PBMT the
      eccentric exercise protocol will be performed. We will analyze maximum voluntary contraction
      (MVC), creatine kinase (CK) activity and delayed onset muscle soreness (DOMS). Assessments
      will be performed at baseline, immediately after (1 minute), 1 hour, 24 and 48 hours after
      the eccentric exercise protocol.
    

Intervention name(s): Photobiomodulation Therapy (PBMT)
Intervention type(s): Device
Intervention description(s): Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sixty participants will be enrolled in the study. Participants will be randomized in six groups:
Control: Participants will receive no intervention; Placebo: Participants will receive placebo PBMT; 5 minutes: Participants will perform the eccentric exercise protocol 5 minutes after PBMT.
3 hours: Participants will perform the eccentric exercise protocol 3 hours after PBMT.
6 hours: Participants will perform the eccentric exercise protocol 6 hours after PBMT.
24 hours: Participants will perform the eccentric exercise protocol 24 hours after PBMT.
Assessments will be performed at baseline, after 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: phototherapy; performance; muscular recovery; photobiomodulation therapy; time-window
Acupuncture for the Treatment of Posttraumatic Stress Among Military Personnel
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effectiveness of acupuncture as a treatment for
      Posttraumatic Stress Disorder (PTSD) among military personnel.
    

Detailed description: 
      Untreated Posttraumatic Stress Disorder (PTSD) leads to decreased force readiness and
      increased health care utilization. Yet, service members with the disorder may be resistant to
      traditional treatments or find them undesirable because of side-effects, stigma, and
      long-term commitment. Acupuncture, which has few known side effects, holds promise as an
      effective treatment option for PTSD. Acupuncture has been shown to improve well-being and has
      been successfully used to treat stress, anxiety and pain conditions. In order to test the
      efficacy of acupuncture for treating the symptoms of PTSD-measured by the PTSD Checklist
      (PCL)-a 12-week, randomized, waitlist-controlled trial will be conducted using a sample of 75
      active duty military personnel. Participants will receive an eight-session acupuncture
      treatment, and will be evaluated throughout the study by way of clinical assessments and an
      independent assessing acupuncturist.
    

Intervention name(s): Acupuncture, using Chinese Medicine methodology
Intervention type(s): Procedure
Intervention description(s): 4 weeks of 2/week treatments (8 total); 4 standardized and 4 individualized treatments
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: PTSD; Posttraumatic Stress; Acupuncture; Randomized Controlled Trial; Complementary medicine; Alternative medicine; Chinese medicine; military healthcare
Implementing Technology Enhanced Real Time Action Observation Therapy in Persons With Chronic Stroke
Condition: Chronic Stroke; Hemiplegia; Hemiparesis; Paralysis
MeSH terms: Stroke; Paralysis; Hemiplegia; Paresis
Study type: Interventional

Summary: 
      This is a feasibility study to alter the Microsoft Kinect software to be used as a
      rehabilitation tool. The prototype used is still in the early developing stage. The purpose
      of this research study is to develop a prototype of altered Microsoft Kinect Software and
      determine its use in improving the function of the study subjects' weaker extremities. The
      altered software will allow a viewing of the mirror image of the involved limb as it is
      moved. However, the image that is viewed will reflect normal movement even if the limb cannot
      move normally. By viewing normal movement of the weaker limbs the "mirror neuron" network in
      the brain will become activated and will ultimately improve the function of the weaker side.
    


Intervention name(s): Real-time action observation with augmented Kinect
Intervention type(s): Device
Intervention description(s): Participants will receive 30 minutes of the augmented kinect software in real-time undergoing an exercise protocol involving seated upper extremity exercises, seated lower extremity exercises and standing upper extremity exercises.
Intervention model: Single Group Assignment
Intervention model description: Single group pre-test/post-test design
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Kinect; Rehabilitation; Virtual reality; Mirror therapy
The Influence of Health Information in Stretch Break Program Participant's Lifestyle
Condition: Health Behavior
Study type: Interventional

Summary: 
      Objective: To verify the influence of information passed during anthropometric assessment
      would have in physical exercise (PhE) and eating habits of 14 participants (female=11;
      51,07+-8,17 years) from the Stretch Break Program of Federal University of Paraíba (SBP of
      FUPb). Methods: The research was a descriptive cross-sectional quantitative and qualitative
      approach. Were applied, between March and May of 2010, anthropometric evaluation and
      semi-structured interviews. During the evaluation were provided information and guidance on
      health.
    


Intervention name(s): Information passed on anthropometric assessment
Intervention type(s): Behavioral
Intervention description(s): Information passed on worker's anthropometric assessment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Information; Lifestyle; Occupational Health
Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children
Condition: Rhinitis, Allergic; Conjunctivitis, Allergic; Asthma
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional

Summary: 
      The objective is to prospectively explore associations between immunological parameters in
      blood and clinical effect of subcutaneous immunotherapy (SCIT) in children with severe
      allergy towards pollen. Half of the children will receive SCIT while the other half will
      start SCIT after the study is finished. Clinical evaluations of symptoms and an immunological
      survey will be performed before start of SCIT and after one year of treatment. Some of the
      immunological parameters will also be checked after 6 months of treatment
    

Detailed description: 
      Before start of SCIT, with Alutard pollenextract/s from " Allergologisk Laboratorium
      Köbenhavn" (ALK), and after one year of treatment, immunoglobulin E (IgE)-antibody levels
      towards the crude allergen and important allergen components in birch and grasspollen
      (timothy) will be measured in blood. While IgE- antibodies are considered to be an indicator
      of allergy IgG- and IgG4-antibodies are considered to be "blocking" antibodies in
      IgE-mediated allergy. Therefore the investigators will measure the IgG- and IgG4-antibody
      levels to crude allergens and applicable allergen components before start, when maintenance
      dose is reached (after 6 months) and after one year of treatment. In order to evaluate
      quality of life, a validated form (DISABKIDS) will be used. Symptom score will be rated by a
      validated form (LILA). The need for medication to treat allergic rhinitis and asthma will be
      assessed using questionnaires. A conjunctival provocation with the applicable allergen(s)
      will be performed before start of SCIT and after one year of treatment.
    

Intervention name(s): Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy; No immunotherapy, symptomatic treatment
Intervention type(s): Drug; Other
Intervention description(s): According to standardized clinical protocol; These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis.
Other intervention name(s): Subcutaneous immunotherapy with grass and/or birch
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Open controlled study
Masking: None (Open Label)
Primary purpose: Other
Blood Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Chronic Haemodialysis Patients
Condition: COVID-19 by SARS-CoV-2 Infection
MeSH terms: COVID-19; Disease Progression
Study type: Interventional

Summary: 
      SARS-CoV-2 induces over-production of inflammatory cytokines, and especially interleukin-6
      (IL-6). The apparently strong association between blood levels of inflammaory cytokines and
      SARS-CoV-2 disease severity has led clinicians to evaluate the administration of steroids or
      anti-IL-6 antagonists in severely ill patients. As of this day, biomarkers capable of
      predicting clinical disease progression in Covid-19 patients with mild-to-moderate symptoms
      have not yet been formally identified. Identifying such markers and evaluating their
      predictive value may be exploited to guide patient care management, and as such forms the
      core objective of this proposal.

      Because of strong inter-individual variations in the ability of innate immune cells to
      produce cytokines, the hypothesis the investigators formulate and intend to test is that
      innate IL-6 responsiveness varies between recently infected Covid-19 patients and could
      predict disease outcome.

      To test this hypothesis, the investigators propose to follow recently infected chronic
      haemodialysis patients with moderate Covid-19 symptoms. These patients stand a higher risk to
      progress to severe disease. The investigators plan to collect a blood sample in these
      patients using a system whereby ex vivo cytokine production is initiated in the very same
      blood collection tube without prior separation and centrifugation, thus reducing labour and
      operator bias. After incubation with or without known innate immune stimuli, the cell-free
      phase from each collection-culture tube will be assayed for IL-6 content. Associations
      between IL-6 content and disease outcome (encephalopathy, transfer to acute care or death)
      will be determined in 115 Covid-19 chronic haemodialysis patients with moderate symptoms
      followed in 9 centers.
    


Intervention name(s): blood sample
Intervention type(s): Other
Intervention description(s): a blood sample is taken on Covid-19 chronic haemodialysis patients with moderate symptoms
Intervention model: Single Group Assignment
Intervention model description: PredictCOVID-D study. Covid-19 chronic haemodialysis patients with moderate symptoms
Masking: None (Open Label)
Primary purpose: Other
Amplifying Graft-Versus-Tumor Effect by Donor Regulatory T-Cell Depletion Before Donor Lymphocytes Infusion
Condition: Hematologic Neoplasms; Relapse
MeSH terms: Hematologic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators have previously shown that depletion of CD4+CD25+FoxP3+ regulatory T cells
      (Treg) enhances the alloreactivity of T lymphocytes, as attested by an accelerated GVHD after
      allogeneic hematopoietic stem cell transplantation (HSCT) in mice. The investigators thus
      propose a clinical trial to test whether Treg-depleted donor lymphocytes infusion (dDLI)
      could induce an improved graft-versus-tumor (GVT) effect in patients refractory to standard
      DLI (stdDLI) for treatment of relapse after HSCT.
    

Detailed description: 
      We have previously shown that depletion of CD4+CD25+FoxP3+ regulatory T cells (Treg) enhances
      the alloreactivity of T lymphocytes, as attested by an accelerated GVHD after allogeneic
      hematopoietic stem cell transplantation (HSCT) in mice. We thus propose a clinical trial to
      test whether Treg-depleted donor lymphocytes infusion (dDLI) could induce an improved
      graft-versus-tumor (GVT) effect in patients refractory to standard DLI (stdDLI) for treatment
      of relapse after HSCT.

      dDLI is administered after failure of 1 or several previous stdDLI of at least 107 CD3+
      cells/kg, defined after a minimal follow-up of 2 months after the last injection. The absence
      of previous clinical manifestations of GVHD is required to be included. To prepare dDLI,
      CD25+ Treg are depleted from donor leukaphereses using anti-CD25 magnetic microbeads and a
      CliniMACS device (MYLTENYI). In order to evidence the potential effect of dDLI, the dDLI cell
      dose is adjusted to be below or equal to the maximal cell dose previously received in stdDLI.
      No comparison is planned in the analysis.
    

Intervention name(s): donor lymphocyte infusion
Intervention type(s): Procedure
Intervention description(s): regulatory T cells depletion
Other intervention name(s): regulatory T cells depletion
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hematological malignancy; allogeneic hematopoietic stem cell transplantation; donor lymphocyte infusion; antitumor immunotherapy; graft-versus-tumor effect; regulatory T cells; adult