bioihbjkbjnl/mcl2 huggingface dataset:
A Drug Interaction Study of Warfarin and Canagliflozin in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the effect of multiple oral doses of canagliflozin on a
      single oral dose of warfarin.
    

Detailed description: 
      This is an open-label (volunteers will know the names of treatments they are assigned)
      single-center study of canagliflozin (JNJ-28431754) and warfarin in healthy adult volunteers.
      Canagliflozin is a drug currently under development to lower blood sugar levels in patients
      with type 2 diabetes mellitus and warfarin is an approved anticoagulant (ie, a drug that
      stops blood from clotting). After an overnight fast (without eating food) of at least 10
      hours, volunteers will receive Sequence 1 (canagliflozin 300 mg, orally, once daily on Days
      1-12 with a single, oral 30 mg dose of warfarin on Day 6 [Treatment A] followed 14 days later
      by a single, oral 30 mg dose of warfarin on Day 1 [Treatment B]) OR Sequence 2 (Treatment B
      followed 14 days later by Treatment A).
    

Intervention name(s): Canagliflozin/Warfarin; Canagliflozin/Warfarin
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A: Tablets, oral, canagliflozin 300 mg, once daily for 12 days and canagliflozin 300 mg + warfarin 30 mg, single dose on Day 6 followed 14 days later by Treatment B: Tablets, oral, warfarin 30 mg, single dose on Day 1; Treatment B: Tablets, oral, warfarin 30 mg, single dose on Day 1 followed 14 days later by Treatment A: Tablets, oral, canagliflozin 300 mg, once daily for 12 days and canagliflozin 300 mg + warfarin 30 mg, single dose on Day 6
Intervention MeSH terms: Canagliflozin; Warfarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Canagliflozin (JNJ-28431754); Warfarin; Pharmacokinetic; Pharmacodynamic; Prothrombin time (PT); International normalized ratio (INR)
Free Fatty Acids-Induced Hypertension in Obese Subjects (Aim #2)
Condition: Hypertension; Diabetes
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to see if salsalate, an Nuclear factor-kappaB (NF-κB) mediated
      inflammation inhibitor, or carvedilol, an α- and β-blocker, will protect against free fatty
      acid induced hypertension, insulin resistance, endothelial dysfunction, inflammation and
      oxidative stress, and autonomic dysfunction in obese normotensive subjects.
    

Detailed description: 
      During postprandial lipemia, dietary triglycerides transported by intestinal chylomicrons are
      hydrolyzed by lipoprotein lipase lining the vascular bed, with subsequent release of FFA for
      transport across the endothelium. Whether the intermittent flux of FFA has the same impact as
      the i.v. lipid infusion will be examined. Decreased endothelial function has been reported
      after a single or long-term dietary high fat load in normal subjects; however, others have
      found no effects on brachial artery vasoreactivity. Our preliminary studies indicate that
      high oral fat loads (60 g) resulted in higher FFA levels and BP changes, and reduced FMD
      compared to low fat load (25 g).
    

Intervention name(s): Salsalate; Carvedilol; Placebo; Intralipid 20%
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Salsalate 750 mg; Carvedilol 3.125 mg; One tablet; 24-hour infusion of Intralipid 20% solution at 20 mL/h (96 g/24 h)
Other intervention name(s): Disalcid; NSAID; Coreg; 20% I.V. Fat Emulsion
Intervention MeSH terms: Salicylsalicylic acid; Carvedilol; Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Phase 1 Study to Investigate the Mechanism of Action of Ipragliflozin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study the effect of ipragliflozin on glucose homeostasis in healthy subjects and T2DM
      subjects, and the effect of exposure of ipragliflozin on urinary glucose excretion and plasma
      glucose in T2DM subjects will be investigated.
    

Detailed description: 
      This study will consist of 2 parts. In Part A the effect of ipragliflozin on the glucose
      homeostasis will be investigated and in Part B we will investigate the effect of exposure of
      ipragliflozin on UGE and plasma glucose levels.

      Part A

      This part will be a randomized, double-blind, placebo-controlled, 2-

      period, 2 treatment crossover design in healthy subjects and in T2DM

      subjects who are drug naïve or washed out for metformin prior to

      admission to the clinical site.

      Part B

      This part will be an open-label, randomized, 2-period, 2 treatment

      crossover design in T2DM subjects stratified by baseline HbA1c

      levels (6.0-6.9%, 7.0-7.9%, 8.0-8.9% or 9.0-9.9%).
    

Intervention name(s): ASP1941; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): Ipragliflozin
Intervention MeSH terms: Ipragliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Ipragliflozin; Phase 1; Healthy; Diabetes Mellitus; Pharmacokinetics; Pharmacodynamics
Strength Training in Nonagenarians
Condition: Elderly
Study type: Interventional

Summary: 
      The Health Enhancing Strength Training in Nonagenarians (STRONG) is a randomised control
      trial to assess the effectiveness of an aerobic and strength training program for improving
      functional capacity and quality of life in nonagenarians. Sixty (51 women) nonagenarians (age
      range: 90-102 years) who live in a geriatric nursing home will be randomly assigned to either
      a usual care (control) group (n=30) or an intervention (training) group (n=30). Participants
      allocated in the usual care group will receive general physical activity guidelines and
      participants allocated in the intervention group will also enroll in three weekly
      non-consecutive individualized training sessions (~45-50 min each) during 8 weeks. The
      exercise program will consist of muscular strength [with a special focus on leg press at 30%
      (start of the program) to 70% 1 repetition maximum (end)] and aerobic exercises
      (cycle-ergometry during 3-5 to 15 minutes at 12-14 points in the rate of perceived exertion
      scale). Results from STRONG will help to better understand the potential of regular physical
      activity for improving the well-being of the oldest population groups.
    


Intervention name(s): 8-week aerobic and strength training program
Intervention type(s): Behavioral
Intervention description(s): Participants allocated in the intervention group will be enrolled in three weekly non-consecutive training sessions for 8 weeks. Each session will last for about 45-50 min. The exercise program will consist of muscular strength and aerobic exercises. Each session will start and end with a low intensity ~5-7 min warm-up and cool-down period respectively, consisting mainly of stretching exercises involving all major muscle groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Functional capacity; Quality of life; Depression; Falls; Body composition; Physical activity
Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids
Condition: Uterine Fibroid; Vaginal Bleeding.
MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of daily dosage of vaginally mifepristone
      on reduction of uterine fibroids size and the symptoms associated with uterine fibroids.
    

Detailed description: 
      Uterine fibroids are benign tumors of the uterus made up of smooth muscle and the
      extracellular matrix proteins Collagen and Elastin. They are exceptionally common; the
      cumulative incidence of a diagnosis of fibroids in women aged 25 to 45 is approximately 30
      percent.

      Uterine fibroids can cause abnormal uterine bleeding, dysmenorrhea, lower back pain and
      non-cyclic pelvic pain. They also can contribute to symptoms related to an enlarging pelvic
      mass (e.g., urinary frequency or constipation).

      Uterine fibroids are also associated with an increased risk of complications of pregnancy,
      and with infertility, although it is unclear whether this association is causative. Symptoms
      associated with uterine fibroids can have a significant impact on quality of life, with
      scores on standard measures that are comparable to those for other major chronic diseases
    

Intervention name(s): mifepristone vaginal tablets
Intervention type(s): Drug
Intervention description(s): Daily use of 10 mg administrated per vagina for 3 months
Other intervention name(s): mifepristone
Intervention MeSH terms: Mifepristone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oral mifepristone; vaginal tablets
Caphosol® Versus State-of-the-art Mouthcare in Patients With Allogeneic Stem Cell Transplantation: a Randomized Controlled Study About the Efficacy of the Mouth Rinse Caphosol®
Condition: Allogeneic Stem Cell Transplantation
Study type: Interventional

Summary: 
      Randomized controlled study about the efficacy of the mouth rinse Caphosol in patients with
      allogeneic stem cell transplantation. 85% of the patients receive a severe oral mucositis due
      to their treatment.

      70 patients will be randomized in the intervention (Caphosol) or in the standard
      (state-of-the-art) group. Primary endpoint is the duration of the mucositis, secondary
      endpoints are the occurence of oral mucositis measured with the WHO-scale and the occurence
      of pain measured with the NRS-scale (Numeric Rating Scale).

        -  Trial with medical device
    


Intervention name(s): Caphosol
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Clinical Study of Fecal Microbiota Transplantation in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)
Condition: Small Intestinal Bacterial Overgrowth; Fecal Microbiota Transplantation
Study type: Interventional

Summary: 
      Small intestinal bacterial overgrowth (SIBO) is defined as the presence of excessive numbers
      of bacteria in the small bowel causing gastrointestinal (GI) symptoms. These bacteria are
      usually coliforms, which are typically found in the colon and include predominantly
      Gram-negative aerobic and anaerobic species that ferment carbohydrates producing gas .Fecal
      Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from
      the feces of healthy people into the intestinal tract of patients. To explore the overall
      efficacy and safety of FMT in the treatment of SIBO.
    


Intervention name(s): Fecal microbiota transplantation
Intervention type(s): Procedure
Intervention description(s): Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
ILSI Energy Balance Study
Condition: Physical Activity
Study type: Observational

Summary: 
      The purpose of this study is to apply measurement error techniques on consumer devices to
      assess rate of energy storage [ES] and energy expenditure [EE], then estimate EI using the
      intake-balance technique.

      The goal of this study is to develop calibration models that will be able to be translated to
      other consumer devices with only minor modifications given common hardware (e.g. triaxial
      accelerometry), resulting in overall improved ability to assess energy balance and EI at a
      population level and positive health outcomes.
    

Detailed description: 
      There are four stages in the proposed project: 1) We will validate EE and ES (hereafter,
      Fitbit_EE and Fitbit_ES) from a consumer physical activity monitor (Fitbit Alta HR™) and body
      composition analyzer (Fitbit Aria™) with gold-standard measures of DLW for EE and DXA for ES
      during a 14-day baseline period; 2) We will estimate EI using the intake-balance method
      during the 14-day baseline period; 3) We will calibrate daily Fitbit_EE and Fitbit_ES from
      consumer devices using a Bayesian semi-parametric measurement error modeling approach to
      estimate energy balance; 4) We will reassess our validation and calibration models of
      consumer devices during a 14-day post-study assessment period to evaluate changes associated
      with growth and development with gold-standard measures of DLW for EE and DXA for ES.

      Aims of the proposed study are to:

      Specific Aim 1. Validate and calibrate consumer devices to estimate energy balance using
      gold-standard methods and a Bayesian semi-parametric approach. Hypothesis 1: We will be able
      to jointly model measurement error for both EE and ES to create a calibration model that
      reduces bias and improves accuracy of consumer devices of EE and ES.

      Specific Aim 2. Estimate energy intake using the intake-balance technique using consumer
      monitors. Hypothesis 2:We will use calibrated EE and ES from consumer monitors to estimate EI
      using the intake-balance technique, with values being superior to self-reported EI.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will include 24 children or adults, ages 8-90.
      
Biospecimen description: 
      Participants will provide a urine samples after which will be analyzed to calculate
      elimination rates of the doubly-labeled water isotopes from the body.
    
Keywords: Energy Balance; Metabolism
Evaluating the Therapeutic Effect of Acupuncture on Acute Ischemic Stroke Patients
Condition: Acute Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional

Summary: 
      The investigators design a randomized, single blinded, control study to evaluate the
      therapeutic effect of acupuncture in acute ischemic stroke patients:
    

Detailed description: 
      Acupuncture therapy in traditional Chinese medicine has been verified in many disease by
      thousands years. Due to the feasible and relatively safe in acupuncture management, now the
      west countries had been well document about acupuncture in medicine. The acupuncture therapy
      applied in post stroke functional recovery has been considered as more benefit than physical
      therapy only to post stroke rehabilitation. However, the effect of combined acupuncture
      therapy with standard management in acute stroke patient still remains unknown. The aim of
      this study is to evaluate the therapeutic effect of acupuncture in acute ischemic stroke
      patients. The prospective study was designed as a randomized, single blinded, control trial.
      We collected newly onset of acute ischemic stroke patient without underling systemic major
      illness, and randomized assign the collected patients into two groups as experimental
      (acupuncture)group and normal control group. The two groups both treat with routine western
      medicine as standard stroke therapy. The outcome measurement will evaluate by the changes
      from baseline at one and three months. The assessed scales including NIH stroke scale, the
      Barthel index, the Functional Independence Measure score, the Fugl-Meyer Assessment, and the
      Modified Rankin Scale. We compared the all variable measurements to see if any benefit from
      acupuncture group than the control group.
    

Intervention name(s): acupuncture
Intervention type(s): Other
Intervention description(s): Intervention with acupuncture
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acupuncture therap; Acute stroke; Randomized controlled trials
Management of Occlusal Dentinal Caries in Deciduous Molars
Condition: Caries, Dental
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study evaluated and compared the efficacy of no caries removal and sealing with a
      well-adapted and crimped stainless steel crown verses selective caries removal upto soft
      dentin and upto firm dentin in healing and/or preventing progression of moderate to deep
      occlusal dentinal caries.
    

Detailed description: 
      Dental caries is a complex multifactorial disease and is one of the most prevalent diseases
      throughout history. It can cost a lot of money to treat and causes infection, pain and the
      loss of teeth. Choices for managing a carious lesion cover a spectrum of options-from
      complete surgical excision, where no part of the visible carious tissue is left in the tooth
      before a restoration is placed, to the opposite extreme, where none of the carious tissue is
      removed and noninvasive methods are used to prevent progression of the lesion. Thus, this
      study compared efficacy of no caries removal and sealing the entire lesion verses partial
      selective caries removal to soft and to firm dentin in healing and/or preventing progression
      of moderate to deep occlusal dentinal caries in previously unrestored teeth by clinical and
      radiographic analysis in 4-7 year old children.
    

Intervention name(s): no caries removal; partial caries removal upto soft dentin; partial caries removal upto firm dentin
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): occlusal caries were treated with no caries removal and placement of stainless steel crown; occlusal caries were treated by partial caries removal upto soft dentin followed by Glass Ionomer Cement placement as a base and composite restoration; occlusal caries were treated by partial caries removal upto firm dentin followed by Glass Ionomer Cement placement as a base and composite restoration
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: occlusal dentinal caries were managed by either partial caries removal upto soft dentin or partial caries removal upto firm dentin or no caries removal and were compared
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: no caries removal; partial caries removal upto soft dentin; partial caries removal upto firm dentin
Single Band vs. Dual Band Pulsed Light Technology for the Treatment of Photodamage - A Split Face Comparison Study
Condition: Photodamage
Study type: Interventional

Summary: 
      Both the Dye - VL 500 - 600 nm and the Dual band will improve significantly the appearance of
      Photo Damage with high efficacy including; safety, minimal discomfort and downtime.
    


Intervention name(s): Single Band vs. Dual Band Pulsed Light Technology for the Treatment of Photodamage
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperpigmentation; Telangiectasias
Magnetic Resonance Spectroscopic Imaging (MRS) and Tumor Perfusion of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide
Condition: Glioblastoma; Glioma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to learn whether 3 tesla (3T) MRI functional imaging will map a
      tumor more accurately allowing a more targeted delivery of radiation. The investigators hope
      to learn whether tomotherapy will be able to deliver higher radiation doses safely to the
      tumor while sparing the surrounding normal tissue.
    


Intervention name(s): Functional MRI imaging and tomotherapy
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: magnetic resonance imaging, functional; radiation therapy; temozolomide; functional imaging; concurrent chemoradiation
A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe
      and effective in the treatment of rheumatoid arthritis.
    


Intervention name(s): AMG 108; AMG 108; AMG 108; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50mg via SC (subcutaneous) injection every 4 weeks; 250mg via SC (subcutaneous) injection every 4 weeks; 125mg via SC (subcutaneous) injection every 4 weeks; Placebo via SC (subcutaneous) injection every 4 weeks
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ACR criteria; methotrexate; DMARDs; patient reported outcomes; joint assessment
Survey of the Need for Information on Fertility and Menopause-Related Treatment Effects Among HSCT Patients
Condition: Stem Cell Transplantation
Study type: Observational

Summary: 
      Primary Objective:

      - To understand the importance of receiving information on fertility- and menopause-related
      treatment effects for female patients undergoing hematopoietic stem cell transplantation.
    

Detailed description: 
      Researchers are currently conducting a survey on how important it is to women who are having
      a stem cell transplant to have information about the effects of the treatment on their
      fertility (their ability to have children) and on the risk of early menopause. Researchers
      know that some women who had transplants think that the information that they received may
      have been lacking or was not appropriate for their needs. Therefore, researchers would like
      to ask women who have had stem cell transplants at M. D. Anderson Cancer Center to report
      what kind of information they got and would like to have gotten before or during their
      treatment.
    

Intervention name(s): Survey
Intervention type(s): Behavioral
Intervention description(s): 3-Part Questionnaire
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Female patients who had a hematopoietic stem cell transplantation between January 1987 and
        September 2004 at M. D. Anderson Cancer Center.
      
Keywords: Fertility; Menopause; Hematopoietic Stem Cell Transplantation; Questionnaire; Survey