bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Different Doses of Dexmedetomidine on Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index: a Double-blinded, Placebo-controlled Trial
Condition: Loss of Consciousness
MeSH terms: Unconsciousness
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of different dexmedetomidine on the
      propofol requirement for loss of consciousness undergoing bispectral index.
    

Detailed description: 
      It has been shown that dexmedetomidine was an efficacious and safe adjuvant in general
      anaesthesia. Administration of dexmedetomidine during the preoperative period has been
      demonstrated to reduce the requirement of opioid analgesics and other sedative and hypnotic
      drugs.Therefore, the study is designed to measure the effect of intravenous dexmedetomidine
      premedication on the propofol dose requirement and bispectral index at loss of consciousness.
    

Intervention name(s): normal saline; dexmedetomidine 0.5 µg/kg; dexmedetomidine 1.0 µg/kg
Intervention type(s): Other; Drug; Drug
Intervention description(s): receive equal volume of normal saline; receive dexmedetomidine 0.5 µg/kg; receive dexmedetomidine 1.0 µg/kg
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Propofol; Dexmedetomidine; Dose; Bispectral index monitor
Mass Balance, Pharmacokinetics, and Metabolism of 14C-labeled ACT-128800 Administered to Healthy Male Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was conducted to investigate the metabolism and mass balance of ACT-128800, and to
      identify the elimination pathways (metabolism and excretion) of ACT-128800 and compare them
      with the known metabolic profiles of ACT-128800 in animals.
    


Intervention name(s): ACT-128800
Intervention type(s): Drug
Intervention description(s): ACT-128800 was supplied as a powder mix in hard gelatin capsules for oral administration. The capsules contained a co-precipitated mixture of non-radiolabeled and 14C-labeled ACT-128800 formulated at a dose strength of 40 mg with a maximum radioactive content of 102 μCi (3.79 MBq).
Intervention MeSH terms: Ponesimod
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: ACT-128800
Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility (P07016)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this trial were to investigate the feasibility and the optimal dose of a
      single administration of Org 36286 to induce monofollicular ovulation in women with WHO Group
      II anovulatory infertility and to assess the safety (including the absence of antibody
      formation) of Org 36286.
    

Detailed description: 
      This was a phase II, randomized, double-blind, placebo controlled, comparative trial to
      investigate the optimal dose of a single administration of Org 36286 to induce monofollicular
      ovulation in women with WHO Group II anovulatory infertility.

      Treatment injection was given on Day 1-3 after the onset of a spontaneous or progestagen
      induced withdrawal bleeding. After injection, ultrasound monitoring and sampling for serum
      hormones were done on treatment Days 3, 5, and daily from Day 7 to 21 or until a urinary
      luteinizing hormone (LH) peak was detected. From treatment Day 7 the urinary LH response was
      assessed to detect the preovulatory LH peak. In case of hyperstimulation, production of
      endogenous gonadotropins could be suppressed by giving daily injections of GnRH antagonist.

      Post-treatment assessments were done in the third week after the urinary LH peak. If no LH
      peak was detected, posttreatment assessments were performed four to five weeks after Org
      36286 or placebo injection.
    

Intervention name(s): Org 36286; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Org 36286 single-dose subcutaneous injection; Placebo to Org 36286 as a single-dose subcutaneous injection
Other intervention name(s): Corifollitropin alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ovulation Induction; Pharmacological effects of drugs; Hormones; Hormone substitutes and Hormone Antagonists; Pharmacological Actions; Randomized; Multi-center; Multi-national
A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH
Condition: Syndrome of Inappropriate Antidiuretic Hormone Secretion
MeSH terms: Inappropriate ADH Syndrome; Diabetes Insipidus; Hyponatremia; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to investigate the efficacy and safety of tolvaptan based on
      the change in serum sodium concentration following administration of tolvaptan oral tablets
      at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.
    


Intervention name(s): Tolvaptan Oral Tablet
Intervention type(s): Drug
Intervention description(s): Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.
Intervention MeSH terms: Tolvaptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Dabrafenib on the Single Dose Pharmacokinetics (PK) of Rosuvastatin and Midazolam
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, multi-center, fixed sequence study in subjects with BRAF V600 mutation
      positive tumors. Subjects will receive single oral doses of 10 milligram (mg) of rosuvastatin
      and 3 mg of midazolam in the morning of Day 1 (alone), Day 8 (with first dose of dabrafenib
      150 mg), and Day 22 (during repeat dose dabrafenib 150 mg twice daily [BID]). Dabrafenib 150
      mg BID will be administered from Day 8 to Day 23. Blood samples for PK analysis will be
      obtained over 32 hours post-dose on Day 1, Day 8, and Day 22. The last dose of dabrafenib
      will be taken in the morning of Day 23 and the last blood sample in the evening of Day 23.
      Subjects will be considered to have completed the study once the 32 hour PK sample has been
      collected on Day 23. Once they have completed the study, eligible subjects may have the
      option to enter study BRF114144, an open-label roll-over study of dabrafenib (no follow-up
      visit required) and continue receiving dabrafenib.
    


Intervention name(s): Rosuvastatin10 mg tablet; Midazolam 3 mg syrup; Dabrafenib 75 mg capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Commercially available Rosuvastatin 10 mg tablets will be supplied. Single oral dose of Rosuvastatin 10 mg will be administered on Day 1, 8 and 22; Commercially available Midazolam syrup will be supplied.Single oral dose of Midazolam 3 mg syrup will be administered on Days 1, 8 and 22; Dabrafenib 75mg will be supplied in the form of capsules. Oral dose Dabrafenib 150 mg (2 x 75 mg) BID will be administered at 12 h apart on Days 8 through 22 and 150 mg (2 x 75 mg) OD on Day 23.
Intervention MeSH terms: Dabrafenib; Midazolam; Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rosuvastatin; BRAF V600; Melanoma; dabrafenib; midazolam
Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-optimization study to
      evaluate the efficacy, safety, and tolerability of NBI-98854 titrated to the subject's
      optimal dose administered once daily (qd) for a total of 12 weeks of treatment in pediatric
      subjects with TS.
    


Intervention name(s): Valbenazine; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): vesicular monoamine transporter 2 (VMAT2) inhibitor; non-active dosage form
Other intervention name(s): Ingrezza; NBI-98854
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis
Condition: Arsenical Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional

Summary: 
      Daily intake of Nigella sativa for 12 weeks is effective in the treatment of palmer arsenical
      keratosis
    

Detailed description: 
      Depending on inclusion and exclusion criteria total 40 patients of palmer arsenical keratosis
      patients (both male and female; age range 18- 60 years) will be recruited from an arsenic
      affected area. Study population will be divided randomly into two equal groups: one group
      will receive vitamin E capsules (200 mg) plus placebo and another group will receive vitamin
      E capsule plus N. sativa capsules (500 mg) twice daily for 12 weeks. Drinking water (50 mL)
      and urine (50 mL) samples will be collected before starting the study and estimate the amount
      of total arsenic in order to confirm the diagnosis. Nail (approx. 1 g) and blood (5 mL)
      samples will be collected both before and completion of the study to see the efficacy and
      safety of the drug. Clinical examinations will be done at regular interval (two weeks).
      Clinical features and adverse effects will be recorded using a structured data collection
      sheet. Plasma cholesterol, vitamin E, and total antioxidant, serum transaminase, billirubin,
      creatinine levels and arsenic level in nail will be measured to evaluate the effectiveness of
      N. sativa on palmer arsenical keratosis patients
    

Intervention name(s): Vitamin E; Nigella sativa; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Vitamin E (200 mg, soft capsule); Nigella sativa (200 mg, soft capsule); Placebo (refined oil in soft capsule with same color and size like that contains N. sativa)
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Arsenic; Keratosis; Nigella sativa; Palm; Vitamin E
Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK
      Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults
      11-25 years of age.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.

      The protocol posting has been updated following a protocol amendment.
    

Detailed description: 
      Subjects 11-25 years of age will be randomized to receive either the meningococcal vaccine
      GSK134612 or Menactra®. An additional non-randomized group of subjects aged 10 years (< 11
      years of age) will be enrolled to receive meningococcal vaccine GSK134612 only (At the time
      the study begun, Menactra® was only licensed in the United States for individuals above 11
      years of age and therefore could not be used as a control vaccine in subjects less than 11
      years old).

      This study will be single-blind for the subjects 11 to 25 years of age and open for the
      subjects 10 to < 11 years of age.
    

Intervention name(s): Meningococcal vaccine 134612; Menactra®
Intervention type(s): Biological; Biological
Intervention description(s): Single dose intramuscular injection.; Single dose intramuscular injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Meningococcal Serogroups A, C, W-135 and/or Y Disease
Apremilast for RAS
Condition: Recurrent Aphthous Stomatitis
MeSH terms: Stomatitis; Stomatitis, Aphthous
Study type: Interventional
Phase: Phase 4

Summary: 
      Determination of treatment efficacy and safety of Apremilast in patients with RAS
    

Detailed description: 
      The study will be a pilot study using apremilast 30mg orally twice daily, for treatment of
      RAS in males and females between 18 and 70 years old.

      Subjects will be recruited from the clinical practice of the Department of Dermatology or
      Division of Rheumatology at Mayo Clinic Florida. Fifteen males and females with RAS will be
      enrolled.

      The study will consist of 3 phases: a screening phase, a 16 week treatment phase and an 8
      week posttreatment observational follow-up phase.

      The screening phase will consist of: obtaining informed consent, demographic information,
      medical history, inclusion and exclusion criteria, prior and concomitant medication use,
      adverse events; collecting vital signs and weight; performing complete physical examination
      and limited physical examination; obtaining hematology, serum chemistry, urinalysis,
      pregnancy test and providing contraception education.

      During the 16-week treatment phase, all subjects receive apremilast.

      All subjects who complete the active treatment phase are to enter the 8-week posttreatment
      observational follow-up phase.
    

Intervention name(s): Apremilast 30mg
Intervention type(s): Drug
Intervention description(s): Apremilast is an oral small-molecule inhibitor of phosphodiesterase (PDE) 4 that works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators. PDE 4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-alfa, IL-23, IL-17 and other inflammatory cytokines. Cyclic AMP also modulates levels of anti-inflammatory cytokines such as IL-10. Apremilast has immunomodulatory activity and, therefore, has the potential to be effective in the treatment of RAS.
Intervention MeSH terms: Apremilast
Intervention model: Single Group Assignment
Intervention model description: Apremilast 30mg orally twice daily for 16 weeks
Masking: None (Open Label)
Primary purpose: Treatment
Research Study in Healthy Volunteers of Patients With Fanconi Anemia, Myeloproliferative Disorders, or Myeloma
Condition: Chronic Myeloproliferative Disorders; Fanconi Anemia; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic/Myeloproliferative Neoplasms
MeSH terms: Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Fanconi Syndrome; Anemia; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Fanconi Anemia
Study type: Observational

Summary: 
      RATIONALE: Analyzing tissue and blood samples from healthy volunteers or patients with
      Fanconi anemia, myelodysplasia, myeloproliferative disorders, or myeloma in the laboratory
      may help doctors learn more about the causes of blood cancers.

      PURPOSE: The purpose of this study is to analyze in the laboratory blood and bone marrow
      cells from healthy volunteers or patients with Fanconi anemia, myeloproliferative disorders,
      or myeloma.
    

Detailed description: 
      OBJECTIVES:

        -  Identify the specific molecular function of the Fanconi anemia (FA) complementing gene
           products in hematopoietic progenitor cells from patients and normal volunteers.

        -  Identify functional defects in hematopoietic stromal cells, including macrophages, from
           patients with FA, and selected blood cancers as well as normal volunteers.

      OUTLINE: Peripheral blood mononuclear leukocytes, skin fibroblasts, and marrow fibroblasts
      are collected for loss-of-function and gain-of-function analysis related to the Fanconi
      anemia complementing gene.
    

Intervention name(s): microarray analysis; polyacrylamide gel electrophoresis; polymerase chain reaction; protein expression analysis; reverse transcriptase-polymerase chain reaction; western blotting; chromatography; high performance liquid chromatography; immunoenzyme technique
Intervention type(s): Genetic; Genetic; Genetic; Genetic; Genetic; Genetic; Other; Other; Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The Center for Hematologic Malignancies, the Knight Cancer Institute at OHSU, and the Bone
        Marrow Failure clinic at Doernbecher Children's Hospital at OHSU will be centers for
        recruitment.
      
Keywords: Fanconi anemia; multiple myeloma and other plasma cell neoplasms; chronic myeloproliferative disorders; myelodysplastic/myeloproliferative neoplasms
Edessy Stem Cell Score (ESS), Endometrium, Endometrioma
Condition: Endometriosis, Ovarian
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      Purpose of this study is to evaluate stem cell expression (SCE) in endometriotic (E) and non
      endometriotic ovarian and endometrial tissues.
    

Detailed description: 
      This study was conducted on 40 women at Al-Azhar University Hospitals. They are divided into
      two equal groups, group 1 with ovarian endometrioma and group 2 with normal ovary. Ovarian
      and endometrial samples were evaluated by hematoxlin & eosin for histopathology (HP) and of
      oct-4 for immunohistochemistry (IH) for SCE.

      Evaluation of IH parameters revealed that the most important factors for evaluating SC were
      arranged as score ( Edessy Stem Cell Score=ESS).
    

Intervention name(s): Ovarian and endometrial samples
Intervention type(s): Procedure
Intervention description(s): Ovarian and endometrial samples were evaluated by hematoxlin &amp;eosin for histopathology (HP) and of oct-4 for immunohistochemistry (IH) for SCE
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Efficiency and Outcomes of Stress-Only Anger and D-SPECT Stress-Only SPECT MPI
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      The purpose of this study is to compare clinical efficiency and patient outcomes using ultra
      low-dose stress only Tc-99m and solid-state SPECT versus traditional Anger SPECT.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients referred for clinically-indicated myocardial perfusion SPECT
      
Keywords: MPI; SPECT; Stress-Only; Spectrum Dynamics Camera; Anger
Nutritional Quality of Egg Proteins and Effect on Satiety
Condition: Physiology; Nutrition
Study type: Interventional

Summary: 
      The project aims to precisely quantify the postprandial amino acid utilization of egg
      proteins in vivo in humans, and also to assess their satiating power, in relation with
      nutrient postprandial waves and incretin secretions. For that purpose, 2 independent studies
      are conducted. The first one is realized using stable isotopes on 8 volunteers ingesting an
      egg test meal. The second one is a cross over design performed on 30 volunteers to compare
      the satiating effect of 2 equivalent snacks: whole eggs or cottage cheese.
    


Intervention name(s): Egg snack; Cottage cheese
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): subject consume 4 cooked whole eggs, providing 380 kcal; Subjects consume 200 g of cottage cheese, providing 380 kcal
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Basic Science
Keywords: ingestive behavior
Feasibility and Effectiveness of Micronutrients as Palliative Care Therapy in Patients With Congestive Heart Failure
Condition: Congestive Heart Failure; Ischemic Cardiomyopathy
MeSH terms: Heart Failure; Cardiomyopathies
Study type: Interventional

Summary: 
      The purpose of this project is to conduct a preliminary test of the feasibility of a
      multi-micronutrient intervention to improve micronutrient status, cardiac function and
      quality of life in Veterans with Congestive Heart Failure (CHF).
    

Detailed description: 
      Veterans with stable CHF resulting from ischemic cardiomyopathy with systolic dysfunction and
      an ejection fraction ≤45% and who fit the criteria of stage B, C and D 2 heart failure will
      be recruited. This is a one group study with Veterans serving as their own control. They will
      receive 50 mg thiamin, vitamin B50 and 220 mg Zn as Zn sulfate daily for 6 months.
      Additionally, they will receive 50,000 IU Vitamin D as ergocalciferol each week for 8 weeks
      then every other week for 16 weeks. Pre (baseline) and post (6 months) cardiac function will
      be tested with echocardiogram and cardiac MR (when applicable), biochemical measures of
      thiamine, pyridoxine, zinc and Vitamin D will be measured at baseline, 3 months, 6 months and
      one year. Quality of life will be measured using the Minnesota Living with Heart Failure
      questionnaire baseline, month 3,6,and one year. Nutritional assessment including a nutrition
      focused physical examination and three days food records will also be measured at baseline,
      month 3, 6 and one year.
    

Intervention name(s): Micronutrients
Intervention type(s): Drug
Intervention description(s): Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
Other intervention name(s): ZnSO4, Vitamin B50, Ergocalciferol, & Thiamin Hydrochloride
Intervention MeSH terms: Ergocalciferols; Thiamine; Micronutrients; Trace Elements
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: thiamin; pyridoxine; vitamin D; zinc; congestive heart failure (CHF); ischemic cardiomyopathy; nutritional injury; quality of life