bioihbjkbjnl/mcl2 huggingface dataset:
Accuracy of Pulse Oximeter With Profound Hypoxia
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Clinical evaluation of the accuracy of SpO2 measurements with the ANNE Limb Sensor compared
      to blood gas analysis in healthy, adult subjects. Hypoxia is induced in patients to different
      and stable levels of SaO2 over the range of 70-100%.
    


Intervention name(s): ANNE Limb Sensor
Intervention type(s): Device
Intervention description(s): Pulse Oximeter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Obesity and the Initiation of Knee Osteoarthritis
Condition: Obesity
MeSH terms: Osteoarthritis; Obesity
Study type: Observational

Summary: 
      Healthy adults aged 20-60 of varying weights will participate in this minimally invasive
      study. There is one 4-hour appointment for which subjects are paid $120. The tests involve: 1
      tube blood draw, 1 gait test (motion capture) and 1 MR of both knees.
    

Detailed description: 
      The tests will be done at the VA and Stanford and are not dangerous or painful. They are
      designed to help us learn more about the relationship of excess weight on cartilage
      degradation by testing a biomarker in blood. Gait testing involves walking in a lab that is
      about 20 meters long about 20 times. MR involves lying in a tube for less than 1 hour.
    

Observational model: Ecologic or Community
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults aged 20-60, of varying weights.
      
Biospecimen description: 
      One tube of blood identified with a unique number.
    
Keywords: obesity; arthritis
Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors
Condition: Recurrent Malignant Solid Neoplasm; Recurrent Melanoma; Recurrent Primary Central Nervous System Neoplasm; Recurrent Thyroid Gland Carcinoma; Refractory Malignant Solid Neoplasm; Refractory Primary Central Nervous System Neoplasm; Thyroid Gland Medullary Carcinoma
MeSH terms: Carcinoma; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Carcinoma, Medullary; Thyroid Neoplasms; Thyroid Diseases; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial studies the side effects and best dose of cabozantinib S-malate in
      treating younger patients with solid tumors that have come back or no longer respond to
      treatment. Cabozantinib S-malate may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of XL184
      (cabozantinib) (cabozantinib S-malate) administered orally to children with refractory solid
      tumors including central nervous system (CNS) tumors.

      II. To define and describe the toxicities of XL184 (cabozantinib) administered on this
      schedule.

      III. To characterize the pharmacokinetics of XL184 (cabozantinib) in children with refractory
      solid tumors.

      SECONDARY OBJECTIVES:

      I. To preliminarily define the antitumor activity of XL184 (cabozantinib) within the confines
      of a phase 1 study.

      II. To assess the biologic activity of XL184 (cabozantinib). III. To assess the biomarker
      response (carcinoembryonic antigen [CEA] and calcitonin) in patients with medullary thyroid
      cancer treated with XL184.

      IV. To evaluate overall survival from study entry through a five-year follow-up period.

      OUTLINE: This is a dose-escalation study. (Complete as of 4/16/2014)

      Patients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-28. Courses
      repeat every 28 days in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at 30 days, 6 months, and then
      annually for up to 60 months.
    

Intervention name(s): Cabozantinib S-malate; Laboratory Biomarker Analysis; Pharmacological Study
Intervention type(s): Drug; Other; Other
Intervention description(s): Given PO; Correlative studies; Correlative studies
Other intervention name(s): BMS-907351; Cabometyx; Cometriq; XL-184; XL184
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      BIOD-961 is a dry powder formulation of glucagon intended for use in a device that mixes
      (reconstitutes) the powder with liquid to make it easier for users to treat patients with
      severe hypoglycemia. The purpose of this study is to evaluate how much BIOD-961 absorbs into
      the bloodstream, how much it raises glucose concentrations (the intended effect) and compare
      to two glucagon products already on the market.
    

Detailed description: 
      Subjects receive on separate days, in random order one of the following: 1 mg BIOD-961
      intramuscularly (IM), 1 mg Lilly (IM), 1 mg Novo (IM), 1 mg BIOD-961 subcutaneously (SC), 1
      mg Lilly (SC), and 1 mg Novo (SC).
    

Intervention name(s): BIOD-961; Lilly Glucagon; Novo Glucagon
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BIOD-961 is a lyophilized glucagon formulation.
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 24 week study comparing the efficacy of four dose levels of INT131 besylate with
      pioglitazone HCl in patients with type 2 diabetes. Eligible patients will be men and women
      (of non-childbearing potential or using dual barrier methods of contraception) between 30 and
      75 years of age who are minimally responsive to treatment with sulfonylurea monotherapy or
      sulfonylurea plus metformin combination therapy.
    


Intervention name(s): INT131 besylate; Pioglitazone HCl; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once-daily, oral; Once-daily, oral; Once-daily, oral
Other intervention name(s): Actos
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 diabetes; diabetes; diabetes mellitus; diabetes mellitus, type 2; non-TZD; thiazolidinedione; selective peroxisome proliferator-activated receptor gamma modulator; SPPARM; peroxisome proliferator-activated receptor gamma; PPAR gamma; insulin sensitizer; glucose control; endocrinopathy; hypoglycemic agent; sulfonylurea; metformin; pioglitazone; nutritional and metabolic diseases
Comparison of Early Endotracheal Tube Insertion With GlideScope Use
Condition: Endotracheal Intubation
Study type: Interventional

Summary: 
      Patients presenting for elective surgery will be randomized to having the breathing tube
      inserted partly into the throat prior to GlideScope insertion, or having it inserted fully
      after GlideScope insertion.
    

Detailed description: 
      Patients presenting for elective surgery requiring orotracheal intubation will be randomized
      to having the Early Endotracheal Tube (ETT) inserted into the pharynx prior to GlideScope
      insertion and then having the ETT advanced under GlideScope guidance into the trachea, or,
      being intubated in the standard fashion with the GlideScope being inserted first and having
      the ETT then advanced via the pharynx into the trachea. The primary outcome is time to
      intubation.
    

Intervention name(s): ETT First (GlideScope)
Intervention type(s): Device
Intervention description(s): Patients will have the endotracheal tube (ETT) introduced into the pharynx under direct vision prior to GlideScope insertion. The ETT will then be advanced under GlideScope guidance into the trachea.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: endotracheal intubation; GlideScope
Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness
Condition: The Primary Objective of This Study Was to Assess the Efficacy and Safety of Hyaluronic Acid Vaginal Gel in Treating Vaginal Dryness
Study type: Interventional
Phase: Phase 2

Summary: 
      This multicenter, randomized, controlled, open-label, parallel-group, 30-day study took place
      at four centers in China. The primary objective of this study was to assess the efficacy and
      safety of hyaluronic acid vaginal gel in treating vaginal dryness. In the current study we
      tested the hypothesis that the efficacy of hyaluronic acid vaginal gel was not inferior to
      that of estriol cream, with no clinically significant difference between them, in the
      treatment of vaginal dryness symptoms.
    


Intervention name(s): Hyalofemme; Estriol cream (Ovestin)
Intervention type(s): Device; Device
Intervention description(s): The treatment in both groups was applied every 3 days for a total of 10 applications. Hyaluronic acid vaginal gel was supplied in a 30g aluminum tube with a vaginal applicator which provides a dose of around 5g; The treatment in both groups was applied every 3 days for a total of 10 applications;Estriol cream was supplied in a 15g vial with a prefilled applicator providing a dose of around 0.5 g
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Study Evaluating Performance of Celliant Fibers on Tissue Oxygenation
Condition: Transcutaneous Oxygen Tension
Study type: Interventional

Summary: 
      The study will evaluate changes in transcutaneous oxygen tension (tcPO2,), and the inferred
      change in local cutaneous blood flow, in healthy subjects wearing a control and a 100%
      Celliant® fiber upper torso garment.
    

Detailed description: 
      Adequate blood supply is necessary for many physiologic processes. However, there are few
      valid, reproducible, non-invasive methods with which to assess it. One such measure is
      transcutaneous partial pressure of oxygen (tcPO2). This measurement is a non-invasive method
      of measuring oxygen tension at the skin surface; represents the amount of oxygen diffusing
      outward across the skin; and can be used as a surrogate for arterial perfusion. This method
      is reproducible with clinically acceptable intrasubject variability; is used for a variety of
      conditions, including peripheral vascular disease evaluation, predicting the outcome of
      patients requiring amputation and survival of skin grafts; and correlates well to angiography
      and increases in blood flow rates. However, tcPO2 is affected by many variables, including
      oxygen concentration in inspired air, lung function and hemoglobin saturation, as well as
      local factors, such as skin thickness, sympathetic tone, the presence of inflammation,
      capillary formation and skin oxygen consumption.
    

Intervention name(s): Celliant; Control
Intervention type(s): Device; Device
Intervention description(s): 100% Celliant garment; Control Garment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Influence of CYP3A4-induction by St. John's Wort on the Steady State Pharmacokinetics of Bosentan
Condition: Drug Interactions
Study type: Observational

Summary: 
      The aim of the present study is to assess the impact of the cytochrome P450 2C9 (CYP2C9)
      genotype (*2 and *3 allele versus wild type; ~3-5% poor metabolisers in Caucasian population)
      on the pharmacokinetics of bosentan and the impact of CYP3A4-induction by St. John's wort
      (SJW) on steady state bosentan which is a CYP3A4 inducer itself.
    

Detailed description: 
      We evaluate the effect of SJW on bosentan pharmacokinetics and its relationship to
      polymorphisms in the CYP2C9 gene known to reduce CYP2C9 activity. This study will be
      conducted at bosentan steady-state because concentrations decrease in the first 10 days of
      treatment due to auto-induction of the metabolism.
    

Intervention name(s): St. Johns Wort
Intervention type(s): Drug
Intervention description(s): Administration of bosentan: 1 x 125 mg p.o. on days 1 and 20, 2 x 62.5 mg p.o. on day 2, 2 x 125 mg p.o. on days 3-19.
Administration of SJW: 3 x 300 mg daily p.o. on days 11-19 and 2 x 300 mg on day 20
Other intervention name(s): Jarsin
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy subjects
      
Keywords: Steady-state; Bosentan; St. Johns Wort
Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Condition: Malignant Neoplasm of Breast
MeSH terms: Neoplasms; Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Options for the treatment of patients who have progressed after an anthracycline and a taxane
      are limited. Capecitabine currently has a role in this setting, yet as many as 80% of
      patients do not respond to this treatment and those who respond eventually develop clinical
      resistance.

      The antitumour activity of vinflunine has been demonstrated in patients with breast cancer
      after exposure to anthracycline and to taxane.

      Vinflunine plus capecitabine has been shown to be a feasible combination for patients
      previously treated with an anthracycline and a taxane. Each drug in combination can be
      administered at efficacious doses.

      This population has few therapeutic options with established clinical benefit. The
      development of a new regimen and potential new standard of care for this group is important.

        -  Primary objective:

           • to compare in patients with advanced breast cancer pretreated with anthracycline and
           taxane the efficacy of the combination of vinflunine and capecitabine with capecitabine
           alone, in terms of progression-free survival.

        -  Secondary objectives:

             -  to evaluate the response rate, the time to response and the duration of response in
                both arms

             -  to compare the disease control rate between arms

             -  to evaluate the duration of disease control in both arms

             -  to evaluate the overall survival in both arms

             -  to evaluate safety

      Methodology This multicentre, open-label, randomised, Phase III study will enrol a total of
      334 patients with advanced breast cancer who have previously been treated with an
      anthracycline and a taxane. Patients will be randomised in a 1:1 ratio to receive VFL plus
      capecitabine (Arm A) or capecitabine alone (Arm B).
    

Detailed description: 
      RECIST 1.1 will be used for tumor assessment CTC - CAE version 3.0 will be used for safety
      assessment
    

Intervention name(s): vinflunine; Capecitabine
Intervention type(s): Drug; Drug
Intervention description(s): intravenous administration day 1 once every 3 weeks, 280 mg/m²; Arm A : 1650 mg/m² Arm B : 2500 mg/m²
Other intervention name(s): Javlor; xeloda; from day 1 to day 14
Intervention MeSH terms: Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physician Led Counseling in Management of Depression in Type 2 Diabetes Mellitus
Condition: Depression; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      There is a high prevalence of depression in patients with diabetes mellitus. Depression has
      been shown to be associated with poor self-management (adherence to diet, exercise, checking
      blood glucose levels) levels in patients with diabetes.To determine whether enhancing quality
      physician's care for depression improves both depression and diabetes outcomes in patients
      with depression and diabetes.
    


Intervention name(s): Physician Supported Care; Usual care
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Psychological counselling; Randomized single blind study; Depression; Diabetes
Diet and Body Composition
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators hypothesize that differential dynamics in fat depots in response to two
      opposing dietary strategies mediate the beneficial metabolic effects during weight loss and
      regain phases.
    


Intervention name(s): Weight-loss diet strategy (+) exercise (PA); weight loss (-) exercise (PA)
Intervention type(s): Other; Other
Intervention description(s): Weight-loss diet strategy with a free gym membership; monthly 60-minute educational workshops; 3 sessions of workout per week of mostly aerobic training; Weight-loss diet strategy without exercise
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: abdominal obesity
The Role Of Omega-3 Fatty Acids In Adolescent Depression
Condition: Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the effects of a 10-week Omega-3 Fatty Acid treatment
      phase on brain chemistry of adolescents with major depressive disorder (MDD) using proton
      magnetic resonance imaging.
    

Detailed description: 
      This study rests on a confluence of findings showing that: 1) Major depressive disorder
      (MDD), is a major public health concern that often emerges in adolescence; which entails 2)
      pathophysiological abnormalities in fronto-striatal structures resulting in death and atrophy
      of glia and neurons; 3) omega-3 fatty acids (FA) effects on brain function in adolescent MDD
      can be assessed by proton magnetic resonance spectroscopy (1H MRS); and, 4) it is critical
      that commonly used complementary and alternative medicines such as omega-3FA that have face
      validity be tested for their neurobiological effect in MDD.

      Using 1H MRSI, this study examines the effects of Omega-3FA on striatal and anterior
      cingulate cortex (ACC) concentrations of the neurocellular biomarkers total choline (tCho),
      total creatine (tCr), and γ-aminobutyric acid (GABA, ACC only) in adolescent MDD. Hypotheses
      are: 1) relative to placebo, omega-3FA treatment will result in significant reductions of
      striatal and ACC tCho and tCr concentrations, and increased ACC GABA; 2: Regardless of
      treatment condition (placebo or Omega-3FA), MDD adolescents who are improved at the end of
      10-week treatment will exhibit a significant decrease in striatal and ACC tCho and tCr
      concentrations, and increases in ACC GABA relative to unimproved adolescents.
    

Intervention name(s): Omega 3 Fatty Acids; Corn oil
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks.; The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell.
Other intervention name(s): Fish oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescents; Major Depressive Disorder; Proton Magnetic Resonance Spectroscopy; Immune System Activation; Omega-3 Fatty Acids
The Infected Bone Nonunion and Soft Tissue Defect of Long Bone Treated Simultaneously With Ilizarov Technique
Condition: Trauma; Orthopedic Surgery Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      In this retrospective study, the investigators evaluated the clinical and functional results
      of infected nonunion of the long bone with soft-tissue defects treated simultaneously with
      Ilizarov technique combining open dressing change in 22 patients. The investigators wanted to
      find out whether that the internal bone transport with external fixator combining open
      dressing change is a valuable method to treatment for those patients with infected bone
      nonunion and poor condition of the soft tissue such as sinus, skin defect.
    

Detailed description: 
      From January 2002 to now, totally 22 patients (18 males, 4 females) were underwent internal
      bone transport for infected nonunion in the long bone with soft-tissue defects. The mean age
      of the patients was 36.5 years (range, 19 to 57). The infected nonunion occurred on the femur
      in 1 patients, the tibia in 21 patients. The hybrid mono-lateral limb reconstruction external
      fixator was used, combined with bone transport. The results were evaluated by the
      classification of the Association for the Study and Application of the Method of Ilizarov
      (ASAMI) which divided into bone and functional categories
    

Intervention name(s): Use it to treatment bone nonunion (Ilzarov)
Intervention type(s): Device
Intervention description(s): Detect the variation of limb lengthening
Other intervention name(s): Ilizarov; Trauma
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: infected; Ilizarov
Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones
Condition: Choledocholithiasis With Cholecystitis
MeSH terms: Cholecystitis; Gallstones; Choledocholithiasis
Study type: Interventional

Summary: 
      The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP
      for CBDs and gallstones.
    

Detailed description: 
      Endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic
      cholecystectomy (LC) is a commonly performed treatment modality for concomitant common bile
      duct stones (CBDs) and gallbladder stones. There has been a debate about the appropriate
      timing of laparoscopic cholecystectomy after ERCP. The present study aimed to compare early
      and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones adding new
      parameters like Nassar scale.
    

Intervention name(s): Laparoscopic cholecystectomy
Intervention type(s): Procedure
Intervention description(s): Laparoscopic cholecystectomy performed after ERCP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Choledocholithiasis; Early; Delayed; Laparoscopic cholecystectomy; ERCP; Nassar scale