bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Study To Evaluate Effect of Food and Diurnal Variation on ABT-869
Condition: Advanced Solid Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      To estimate the effect of food on the oral bioavailability and effect of diurnal variation on
      the pharmacokinetics of ABT-869.
    

Detailed description: 
      This study is a pharmacokinetic study designed to evaluate the effect of food on the oral
      bioavailability and effect of diurnal variation on the pharmacokinetics of ABT-869.
      Triplicate ECG performed to determine the effect of ABT-869 on QT prolongation . Subjects may
      continue receiving linifanib after completion of the study.
    

Intervention name(s): ABT-869
Intervention type(s): Drug
Intervention description(s): 0.25 mg/kg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Conjugated Linoleic Acid Supplement on Body Composition
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to examine the effects of a low and high dose of
      conjugated linoleic acid supplement on body composition in obese humans. Individuals with a
      body mass index between 30 and 35kg/m2 are randomized to receive either placebo, 3.2gCLA, or
      6.4g CLA daily for twelve weeks. Changes in body composition, weight, and clinical laboratory
      values are compared between the three groups.
    

Detailed description: 
      Sixty healthy obese adult volunteers will be enrolled and randomized into either: 1) placebo,
      2) 3.2 g CLA, or 3) 6.4 g CLA groups and supplemented for 12 weeks. Body fat mass (BFM) and
      lean body mass will be determined by DEXA at baseline and twelve weeks during the
      intervention. In addition, indirect calorimetry will be performed at baseline and twelve
      weeks to measure changes in energy expenditure. The effect of CLA supplementation on weight,
      waist and hip measurements, and BMI will also be determined at 12 weeks. Plasma CLA and pill
      counts will be measured as an indication of compliance. Several blood parameters will be
      monitored throughout the study, and five random 24-hour recall surveys will be used to
      monitor dietary intake of CLA-rich foods, energy, micronutrients and antioxidants.
    

Intervention name(s): Tonalin Conjugated linoleic acid (dietary supplement)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: conjugated linoleic acid; obesity; body composition; body fat mass; lean body mass
Pizza Meal Challenge and Immunometabolism (PIMETA)
Condition: Healthy
Study type: Interventional

Summary: 
      High salt intake is a major risk factor for cardiovascular events, including stroke, heart
      disease and kidney failure. Pizza is a popular salty food. In this exploratory pilot study,
      the effects of a pizza meal challenge on immunometabolism in healthy subjects will be tested.
    


Intervention name(s): Pizza meal challenge
Intervention type(s): Other
Intervention description(s): Vegetarian pizza containing 10 grams of salt
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Salt challenge; Immune cell metabolism; Oxygen consumption rate; Extracellular acidification rate; Cytokine production
A Clinical Trial to Study the Effects of Revamilast in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Rheumatoid arthritis (RA) is a systemic autoimmune and chronic inflammatory disease that
      causes progressive damage to joints of the body, affecting the functional capacity. Effective
      management of patients with RA requires a multidisciplinary approach. Despite the various
      combinations, there is a significant population of RA patients who are not responding to
      these combinations or showing inadequate response to methotrexate alone. Hence, there is a
      need for a unique combination of drugs targeting different pathological process to yield the
      best results in those patients where prognosis is poor. Combination of revamilast with first
      line therapy like methotrexate could provide better treatment options to a larger population
      of RA patients having moderate to severe disease and who are inadequately controlled on one
      or the other DMARDs.

      This is randomized, double-blind, placebo-controlled, parallel group study. The study will
      include patients with active RA receiving stable and maximum tolerated dose of MTX.

      Patients will be recruited after providing written informed consent. After screening and run
      in period (single blind placebo for 4 weeks), patients will be randomized (meeting
      randomization criteria) in 1:2:2:2 ratios to receive either one of three doses (Low, Medium
      and High) of revamilast or placebo along with MTX.

      The primary objective of the study is to determine the percentage of patients achieving ACR20
      response at 12 weeks. Secondary objectives include determining percentage of patients with
      ACR50 and ACR70 response, change in DAS-28 score, change in serum CRP and ESR values and
      frequency and use of rescue medication.

      During the treatment period, there will be 5 further study visits at week 2, week 4, week 8,
      week 12, for efficacy, safety and tolerability assessment and visit at week 14 will be follow
      up visit.
    


Intervention name(s): Revamilast; Revamilast; Revamilast; Placebo Comparator
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet, Low dose, Once daily for 12 weeks; Tablet, Medium dose, Once daily for 12 weeks; Tablet, High dose, Once daily for 12 weeks; Matching Placebo in triple dummy format, Tablet, Once daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anti-inflammatory drugs, DMARD
Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Study type: Interventional
Phase: Phase 1

Summary: 
      To describe the rate of post-collection TU to testosterone conversion, as manifested by
      increases in testosterone concentration, in Plain tubes held at room temperature and sodium
      fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on
      ice prior to centrifugation
    

Detailed description: 
      This was an open-label, non-randomized, single-sequence study in which men dosed with JATENZO
      had blood drawn into 3 different types of blood-collection tubes (ie, Plain, EDTA, and
      NaF-EDTA). These tubes were then processed in different ways (ie, different durations between
      phlebotomy and centrifugation, different holding temperatures [room temperature or on ice]
      between phlebotomy and centrifugation). After defined periods of incubation, the tubes were
      centrifuged and the serum/plasma transferred into vials and frozen. The testosterone and TU
      levels in the serum/plasma were then measured using validated liquid chromatography/tandem
      mass spectrometry assays.
    

Intervention name(s): Testosterone Undecanoate
Intervention type(s): Drug
Intervention description(s): dose was given orally and allowed to reach steady state
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Indole-3-Carbinol in Preventing Breast Cancer in Nonsmoking Women Who Are at High Risk For Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. Indole-3-carbinol may be effective in preventing breast
      cancer.

      PURPOSE: Phase I trial to study the effectiveness of indole-3-carbinol in preventing breast
      cancer in nonsmoking women who are at high risk for breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety and tolerability of indole-3-carbinol for the prevention of breast
           cancer in non-smoking women at high risk for breast cancer.

        -  Determine the pharmacokinetics of this drug in these participants.

        -  Determine the effect of this drug on metabolites of estrogen in urine of these
           participants.

        -  Determine other additional effects of this drug on selected indicators of drug
           metabolism and reproductive and hormonal function in these participants.

        -  Assess any possible antineoplastic activity of this drug in these participants.

        -  Determine the quality of life of participants receiving this drug.

      OUTLINE: This is a single-blind study.

      Participants ingest study compound twice daily on weeks 1-12 or 1-16. Study compound is
      dispensed on weeks 1, 5, and 9. At times, study compound is oral placebo, and at other times,
      oral indole-3-carbinol.

      Quality of life is assessed at baseline and then every 4 weeks during study therapy.

      PROJECTED ACCRUAL: A total of 18 participants will be accrued for this study within 9 months.
    

Intervention name(s): Indole-3-carbinol; Indole-3-carbinol; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 400 mg pill taken daily; 800 mg pill taken daily; Placebo pill taken daily during run-in period
Other intervention name(s): I3C; I3C
Intervention MeSH terms: Indole-3-carbinol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breast cancer
A Phase IIA Study of BMS-512148 to Assess Safety, Exposure, and Biological Effects in Stable Type 2 Diabetic Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical research study is to assess the safety of, exposure to, and
      biological effects of BMS-512148 in stable Type 2 diabetic subjects
    


Intervention name(s): BMS-512148; BMS-512148; BMS-512148; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules, Oral, 100 mg, Once daily, 14 days.; Capsules, Oral, 25 mg, Once daily, 14 days.; Capsules, Oral, 5 mg, Once daily, 14 days.; Capsules, Oral, 0 mg, Once daily, 14 days.
Other intervention name(s): Dapagliflozin; Dapagliflozin; Dapagliflozin; Dapagliflozin
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Algorithm for Epilepsy Alert Device
Condition: Motor Seizures
MeSH terms: Epilepsy; Seizures
Study type: Observational

Summary: 
      An accelerometer with transmitting ability is worn on the wrist. Data of movements during
      seizures will be analyzed to upgrade algorithm that will identify seizures.
    

Detailed description: 
      Patients undergoing Video-EEG telemetry will wear movement sensor on their wrist. The sensor
      will transmit continuous data to a laptop. Seizures' data (tonic or clonic) will be analyzed
      and transformed into an algorithm (up-graded existing preliminary algorithm).

      In the second phase the algorithm will need to identify seizure events within one minute of
      the onset.

      Both specificity ("false positive") and sensitivity ("false negative) will be than
      calculated.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to Video-LTM Unit with motor seizures.
      
Biospecimen description: 
      no Biospecimen
    
Keywords: motor seizures; accelerometer; algorithm; detection; alert
First in Man Trial of BI 113608
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the current study is to investigate the safety and tolerability of
      BI 113608 in healthy male volunteers following oral administration of single rising doses.

      A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single
      dosing.
    


Intervention name(s): BI 113608; BI 113608; BI 113608; BI 113608; Placebo; BI 113608; BI 113608; BI 113608; BI 113608; BI 113608; BI 113608
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Low dose powder for oral solution; High dose powder for oral solution; Medium dose powder for oral solution; Low dose powder for oral solution; Powder for oral solution; Low dose powder for oral solution; High dose powder for oral solution; High dose powder for oral solution; Medium dose powder for oral solution; Medium dose powder for oral solution; Low dose powder for oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Vitamin D as a Prognostic Marker on Assisted Reproductive Technologies Outcomes.
Condition: Role of Vitamin D in IVF for Better Outcome
Study type: Interventional

Summary: 
      Studying the effect of Vitamin D administration on assisted reproductive outcomes in women
      undergoing Intra Cytoplasmic Sperm Injection (ICSI) by giving a dose of vitamin D and
      determining the effect of this dose on both the quality embryos, implantation and ongoing
      pregnancy rate.
    

Detailed description: 
      1. Ninty women will include in the study. All patients will be treated with gonadotropin
           releasing hormone (GnRH) agonist "Decapeptyl" 0.1 mg subcutenoussubcutaneous
           "FeringFerring, Germany" and vitamin D (D- Dep) from day 20 of the preceding cycle till
           the day of HCG administration for preparation of ICSI.

        2. Controlled ovarian hyper stimulation will be done with Gonal F "recombinant FSH",
           starting from day 3 of the stimulation cycle according to the standard protocol of the
           center. The dose is calculated according to the ovarian reserve, age as the BMI.

        3. HCG and Vitamin D will be given when one or more of the growing follicles reaching 17 mm
           of diameter or more.

        4. Ovum pickup was done guided by the transvaginal ultrasonography 34-36 hours after HCG
           administration. Follicular fluid and blood sample were obtained at the time of ovum
           pickup for ICSI/IVF.

        5. This prospective randomized case control trial will include 90 women who will be
           allocated IVF/ICSI. They will be sub divided into a study and a control group; each
           group will include 45 women.
    

Intervention name(s): Vitamin D
Intervention type(s): Drug
Intervention description(s): To investigate role of vitamin D in follicular maturation and number of mature follicles which help in the success of IVF procedure
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: ICSI- Vitamin D- BMP-15 protein
Prospective, Multicenter, Investigation of the Adagio Cryoablation System in Subjects With Atrial Flutter
Condition: Atrial Flutter
MeSH terms: Atrial Flutter
Study type: Interventional

Summary: 
      The objective of the study is to demonstrate the safety and feasibility of the Adagio System
      in subjects with Atrial Flutter.
    


Intervention name(s): PolarStart System
Intervention type(s): Device
Intervention description(s): Atrial flutter Ablation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)
Condition: Intracranial Hypertension
MeSH terms: Intracranial Hypertension; Hypertension
Study type: Observational

Summary: 
      The aim of this study is to determine whether we can predict the intracranial pressure using
      near infra-red spectroscopy
    

Detailed description: 
      The management of intracranial hypertension requires the presence of an intracranial pressure
      monitor. We are investigating whether the waveforms obtained from a near infrared
      spectroscopy device can predict what the intracranial pressure is non-invasively.

        -  Patients with intracranial hypertension who are intubated and ventilated in the ICU will
           be recruited

        -  we will record there intracranial pressure and systemic arterial pressure

        -  recordings from the near infrared device will be recorded and analysed off-line

        -  we will correlate the waveform tracings from near infrared spectroscopy and the arterial
           tracing
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients in the ICU with intracranial hypertension, being monitored with an arterial
        catheter and intraranial pressure monitor
      
Keywords: Intracranial hypertension; intracranial elastance
Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety
      profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg
      per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI)
      Active Control.

      This study will be conducted in male and female adult patients who have mild-to-moderate
      persistent asthma for at least 6 months, but are otherwise generally healthy.
    

Detailed description: 
      The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety
      profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg
      per dose in comparison to the DPI Placebo Control and the Active (Reference) Control. The
      study results of this study together with that of A006-B study will be utilized to determine
      the optimum final dose range of A006 for further clinical studies.

      The study will be conducted in male and female adult patients who have mild-to-moderate
      persistent asthma but are otherwise generally healthy.
    

Intervention name(s): Albuterol DPI 25 mcg/inh; Albuterol DPI 90 mcg/inh; Placebo DPI; Albuterol MDI 90 mcg/inh
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Albuterol DPI with 25 mcg Albuterol/inhalation; Albuterol DPI with 90 mcg Albuterol/inhalation; Placebo DPI with 0 mcg Albuterol/inhalation; Albuterol MDI with 90 mcg Albtuerol/inhalation
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma; mild-to-moderate persistent asthma; mild asthma; moderate asthma; persistent asthma
Comparative Pharmacokinetics Study of Clopidogrel and Aspirin Fixed-dose Combination Versus Separate Combination-2nd Trial
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare pharmacokinetics between fixed-dose combination and
      separate combination of clopidogrel 75mg/aspirin 100mg.
    


Intervention name(s): Clopidogrel and Aspirin; Fixed dose combination of clopidogrel/aspirin
Intervention type(s): Drug; Drug
Intervention description(s): Clopidogrel and Aspirin seperate combination, single dose; Fixed dose combination of clopidogrel/aspirin
Other intervention name(s): Clopidogrel: Plavix; Aspirin: Astrix; Coprigrel
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clopidogrel; Aspirin; Combination; Pharmacokinetics; Phase 1
Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty
Condition: Knee Replacement Surgery; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy and safety of FLOSEAL to standard of
      care for hemostasis in subjects undergoing total knee arthroplasty.
    


Intervention name(s): Standard of Care; FLOSEAL Hemostatic Matrix + Standard of care
Intervention type(s): Procedure; Drug
Intervention description(s): Conventional hemostatic techniques, such as cautery and manual compression, will be used.; FLOSEAL will be applied topically to areas of the knee where bleeding is observed (e.g. cut bone surfaces, subcutaneous tissue, posterior joint capsule, synovial tissue, medial and lateral gutters, branches of the genicular vessels, and suprapatellar pouch) and will occur intraoperatively. Sufficient amounts of FLOSEAL will be applied quickly using the provided applicators, followed by immediate approximation with a damp gauze, lap pad or sponge for approximately 2 minutes.
+ Standard of care: conventional hemostatic techniques, such as cautery and manual compression, will be used
Other intervention name(s): FLOSEAL
Intervention MeSH terms: Hemostatics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment