bioihbjkbjnl/mcl2 huggingface dataset:
The Hemodynamic Effects of CGRP After Glibenclamide Administration in Healthy Volunteers
Condition: Hemodynamics of Cranial Arteries; Headache; Cerebral Blood Flow
MeSH terms: Headache
Study type: Interventional

Summary: 
      To investigate the hemodynamic effects of CGRP after glibenclamide administration.
    

Detailed description: 
      20 healthy participants will randomly be allocated to receive CGRP infusion followed by
      glibenclamide or placebo on two different days.

      The aim of the study is to investigate the vascular effect of CGRP after glibenclamide
      administration.

      Repeated measurements covering the arteria radialis (RA), superficiel temporal artery (STA)
      and middle cerebral artery (MCA) before and after glibenclamide/placebo administration and
      CGRP infusion.
    

Intervention name(s): glibenclamide; CGRP infusion; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration of glibenclamide or placebo. To investigate the role of CGRP on cranial arteries in healthy volunteers after glibenclamide/placebo administration .; CGRP infusion; placebo
Intervention MeSH terms: Glyburide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Phase 2 Study With IPI-926 in Patients With Myelofibrosis
Condition: Primary Myelofibrosis; Fibrosis, Bone Marrow
MeSH terms: Primary Myelofibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of IPI-926 in patients with
      myelofibrosis (MF) (primary myelofibrosis [PMF], post-polycythemia vera myelofibrosis
      [post-PV MF], or post-essential thrombocythemia myelofibrosis [post-ET MF]).
    


Intervention name(s): IPI-926
Intervention type(s): Drug
Intervention description(s): Single Arm study of oral IPI-926 at 160 mg, 130 mg or 110 mg daily, until progressive disease or intolerability to study treatments or withdrawal of ICF
Other intervention name(s): Hedgehog Inhibitor; Hedgehog Pathway Inhibitor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IPI-926; 926; Myelofibrosis; Hedgehog; Infinity Pharmaceuticals; Post Essential thrombocythemia; Post Polycythemia vera
Safety and Efficacy of Berodual® Inhaled Via Respimat® Compared to MDI (Metered Dose Inhaler) in Pediatric Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol
      hydrobromide + 20 µg ipratropium bromide and 25 µg fenoterol hydrobromide + 10 µg ipratropium
      bromide, 1 puff t.i.d.) administered via Respimat® device gives a bronchodilator response
      which is not inferior to that obtained from one dose of Berodual® (50 µg fenoterol
      hydrobromide + 21 µg ipratropium bromide, 2 puffs t.i.d.) administered via the MDI
      (chlorofluorocarbon-metered dose inhaler) with Aerochamber® and that the safety profile is at
      least as good when paediatric asthma patients are treated for four weeks.
    


Intervention name(s): Berodual® Respimat®, low dose; Berodual® Respimat®, high dose; Berodual® MDI
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Fenoterol; Fenoterol, ipratropium drug combination; Ipratropium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study of Two Macitentan Pediatric Formulations in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the rate and extent of absorption of macitentan
      following administration of a single oral dose of macitentan formulated as final market image
      (FMI) (test), compared to macitentan as the clinical service formulation (CSF) under fasted
      conditions in healthy adult participants.
    


Intervention name(s): Macitentan
Intervention type(s): Drug
Intervention description(s): Macitentan dispersible tablets will be administered orally as per assigned treatment sequence.
Other intervention name(s): Opsumit; ACT-064992
Intervention MeSH terms: Macitentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Use of Predictive Model to Assist Patients Having an Embryo Transfer After IVF
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      To determine in women undergoing IVF who are at high risk of multiple births (>35%), as
      calculated by the application of a predictive model - IVFsingleTM, if single embryo transfer
      will lead to both comparable clinical pregnancy rate (CPR) and other secondary outcomes such
      as live birth rate (LBR) and cumulative live birth rate (cLBR) in comparison to DET while
      reducing the incidence of multiple births (a secondary outcome measure).
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women under age 38 undergoing 1st or 2nd IVF treatment who havae not had previous IVF
        pregancy nor cancelled IVF cycle for poor response.
      
Keywords: predictive model; in vitro fertilization; elective single embryo transfer
RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia
Condition: Male Infertility, Azoospermia
MeSH terms: Infertility; Infertility, Male; Azoospermia
Study type: Interventional
Phase: Phase 2

Summary: 
      Men with infertility and normal hormone levels have few options for fertility treatment.
      Previous research suggests that men with infertility may have low levels of the active form
      of Vitamin A, called retinoic acid, in their testes. In a pilot study of 20 men with low
      numbers of sperm (<10 million motile sperm), roughly half the men showed improvement in sperm
      production. Thus, we want to see if retinoic acid administration to men with azoospermia (no
      sperm present) can initiate sperm production.
    

Detailed description: 
      Twenty men with infertility, aged 21 - 60, due to azoospermia (no apparent sperm in the
      ejaculate on two separate occasions) will be enrolled in a single-arm pilot trial of daily
      oral therapy of 20 mg twice daily of 13-cis retinoic acid for 32 weeks. The impact of
      treatment on the appearance of sperm in the ejaculate will be determined by monthly semen
      analyses.

      Note: The outcome measure of serum and seminal plasma 13-cis-retinoic acid concentrations was
      entered in error and not intended to be reported for this study. Information on these levels
      is available in our earlier study of 13-cis-retinoic acid in men with sub-fertility. Amory et
      al. Andrology 2017 5:1115-1123.
    

Intervention name(s): 13-cis retinoic acid
Intervention type(s): Drug
Intervention description(s): Accutane is used for the treatment of severe acne
Other intervention name(s): Accutane, Isotretinoin
Intervention MeSH terms: Tretinoin; Isotretinoin
Intervention model: Single Group Assignment
Intervention model description: 20 mg 13-cis retinoic acid twice daily (BID) with meals for 32 weeks
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infertility
Dermacyd PH_DESILSTY_FL (Lactic Acid) - Acceptability - Stay on Floral.
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To prove the safety of the gynaecological formulation in normal conditions of use.
    


Intervention name(s): LACTIC ACID(ND)
Intervention type(s): Drug
Intervention description(s): Treatment duration: 21 consecutive days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic
      children and adults.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy and
      safety of ADP101 for oral immunotherapy in food allergic children and adults.
    

Intervention name(s): ADP101 vs Placebo Dose Regimen A; ADP101 vs Placebo Dose Regimen B
Intervention type(s): Biological; Biological
Intervention description(s): Active powder formulation at various volumes. Placebo powder formulation at various volumes.; Active powder formulation at various volumes. Placebo powder formulation at various volumes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADP101; Allergy; Oral immunotherapy; OIT; Allergies; Food allergies; Multi-food allergic; Multi-allergen oral immunotherapy; Tree nut allergy; Milk allergy; Wheat allergy; Egg allergy; Fin fish allergy; Shrimp allergy; Peanut allergy; Sesame seed allergy; Soy allergy; Shellfish allergy; Fish allergy; Seafood allergy; Dairy allergy; Desensitization; Food hypersensitivity; Immune system disease; Hypersensitivity, immediate; Hypersensitivity
Post-exercise Dietary Protein Strategies
Condition: Optimal Anabolic Nutrition Interventions
Study type: Interventional

Summary: 
      Protein ingestion increases the rate at which the body builds new proteins in skeletal muscle
      (muscle protein synthesis. This study is designed to examine how the pattern of feeding
      affects muscle protein synthesis following resistance exercise. There is reason to believe
      that the large rapid increase in blood amino acid concentrations that accompanies the
      ingestion of a bolus of protein is important to increasing muscle protein synthesis. Thus, we
      hypothesize that the consumption a bolus of protein will elevate muscle protein synthesis to
      a greater extent than the consumption of an equivalent amount of protein that is consumed in
      small divided doses.
    

Detailed description: 
      The rapid appearance into the blood of essential amino acids, and leucine in particular, may
      act as an important signal to stimulate muscle protein synthesis after resistance exercise.
      This may explain why consuming rapidly-absorbed whey protein may have an anabolic edge over
      slowly-absorbed proteins such as casein. Previous investigations into importance of the rate
      of absorption to muscle protein synthesis that have used 'fast' and 'slow' proteins have been
      confounded by differences in amino acid composition. The present study addresses this issue
      by administering the same protein source, whey, as either a bolus or in small divided 'pulse'
      doses to achieve divergent amino acid profiles after a bout of resistance exercise.

      This study is being conducted in young (18-35) men.

      Our outcome measures include: blood amino acid concentrations, rates of myofibrillar protein
      synthesis, anabolic intracellular signalling markers
    

Intervention name(s): whey protein bolus; whey protein pulses
Intervention type(s): Other; Other
Intervention description(s): single dose of 25 g whey protein; 10 2.5 g pulses of whey protein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Pectoral Nerve Block for Analgesia After Breast Augmentation
Condition: Ambulatory Plastic Surgery; Esthetic Prosthetic Breast Expansion
Study type: Interventional
Phase: Phase 3

Summary: 
      Breast augmentation is among the most popular surgical procedures performed in the world with
      approximately 1,773,584 performed in 2013. This surgical intervention generates important
      pains during postsurgical recovery. A multimodal analgesia, based on the recommendations is
      proposed to the patients .The pectoral nerve block is an innovative technique of locoregional
      anesthesia that has already been successfully used in breast surgery. Its realization is
      fast, simple, and it would be superior compared with a paravertebral block within the
      framework of mastectomy. The interest of this technique has never been assessed in esthetic
      breast surgery. The aim of this study is to evaluate the analgesic efficacy of the
      association of " Pecs blocks 1 and 2 " on pain intensity after breast augmentation surgery.
    

Detailed description: 
      The investigators hypothesized that the "Pecs blocks 1 and 2" will provide a decrease of the
      maximal pain of the first 6 post-operative hours after prosthetic breast expansion. The pain
      will be assessed according to a numerical scale. This prospective, randomized, double blind
      study will include 92 patients successively during two years, randomized into two arms : Pecs
      group and Control group, which will respectively have the block, and no block. The rest of
      the anesthesic and surgical care will be identical.

      An intervention team (which will be different from the anesthesic team), will be alone with
      the patient for 15 minutes, and will realize or not the Pecs blocks according to the previous
      randomisation so that all caregivers taking in charge the patients as well as research
      observers will be blinded.
    

Intervention name(s): Ropivacaine after dilution with sodium chloride 0.9%
Intervention type(s): Drug
Intervention description(s): After the anesthesic induction, the interventional team composed by at least a senior anaesthesiologist and a nurse anesthestic, will survey the patient and perform the Pecs blocks, whereas the anesthetic team is outside the room.
Realization of Pecs blocks 1 and 2 : the patient is in supine position with placing the upper limb in abduction position, a 100 mm needle is inserted under ultrasound using a linear US probe of high frequency after sheathing.
In the other group, sterilization, sheating and US are performed but the needle is not inserted.
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prosthetic breast surgery; Locoregional anesthesia; Pectoral nerve block; Pain; Postoperative analgesia
Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 12-week, randomized, double-blinded, placebo-controlled trial of telmisartan 80
      mg/day as an adjunctive to clozapine or olanzapine therapy, in 70 schizophrenia subjects to
      examine telmisartan's effect on glucose metabolism, weight, food intake, resting energy
      expenditure, and body composition. In addition, the study will examine insulin's effects on
      psychopathology and cognition.

      Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or
      Massachusetts General Hospital. Approximately 70 subjects will be enrolled.
    

Detailed description: 
      The specific aims include:

      Primary Aims:

        1. Examine the efficacy of telmisartan added to regular doses of clozapine or olanzapine in
           improving insulin resistance.

        2. Examine the efficacy of telmisartan in reducing fasting triglycerides.

      Secondary Aims:

        1. Examine the effects of telmisartan on negative symptoms, positive symptoms, and
           cognitive function.

        2. Examine telmisartan's effects on lipids, body composition, and waist/hip ratio.

        3. Examine telmisartan's effects on inflammatory biomarkers including C-reactive protein
           (CRP) and interleukin 6 (IL-6).
    

Intervention name(s): Telmisartan; Placebo; Clozapine; Olanzapine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Telmisartan 40mg/day for the first 2 weeks.
Telmisartan 80mg/day for the next 10 weeks.; Placebo (plus existing clozapine or olanzapine treatment) for 12 weeks.; Clozapine (plus telmisartan or placebo) for 12 weeks.; Olanzapine (plus telmisartan or placebo) for 12 weeks.
Intervention MeSH terms: Telmisartan; Olanzapine; Clozapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Cognition; Metabolism; Antipsychotics; Psychopathology
Imaging Lung Function Using Oxygen Enhanced MRI
Condition: COPD; Asthma; Cystic Fibrosis; Emphysema; Small Airways Disease
MeSH terms: Cystic Fibrosis; Emphysema
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to perform a pilot study to evaluate the utilization of oxygen as
      an inhaled contrast agent to image the airway spaces in normal and diseased human lungs to
      allow an effect size estimate to power future studies.
    

Detailed description: 
      This is an open label study expanding on work by other groups in animals, ex-vivo human lungs
      and human subjects. Both 2-dimensional and 3-dimensional images will be obtained using 1H MRI
      comparing images obtained while breathing oxygen to those obtained breathing room air.

      Objectives

        -  To determine if 1H magnetic resonance images of the human lung and airways can be
           obtained in both single breath-hold and gated breathing imaging studies with adequate
           signal level and image contrast to extract regional lung functional information with
           oxygen as a contrast agent.

        -  To determine the short term reproducibility of the lung functional imaging in a subset
           of subjects (5 control subjects and 5 subjects with lung disease) with repeat MRI
           studies (Visit 2) at a time point ≥ 1 week to ≤ 4 weeks from Visit 1
    

Intervention name(s): Medical Grade Oxygen
Intervention type(s): Drug
Intervention description(s): At the study visits, MRI 'studies' will be performed using the same MR scanner (a 3.0-Tesla (T) TRIO MRI system (Siemens Medical Systems)). Lung morphology and function will be acquired using conventional 1H MRI followed by 1H MRI with oxygen as a gaseous contrast agent. For both series the subject will lie down in a supine position on the magnet bed with a standard 1H Torso coil for imaging. Subjects are scanned on room air and then the subjects are switched from room air to 100% oxygen and exhaled O2/CO2 are monitored (Oxigraf Capnograph) until steady state is achieved (in our experience ~ 1-2 minutes). The 100% oxygen MRI imaging is commenced (the average exposure time is usually 5-6 minutes with a maximum exposure of 15 minutes) after which the subjects are switched to room air. After steady state is achieved a second room air scan is completed.
Other intervention name(s): oxygen
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Does a Migraine Medication Decrease Rotational Motion Sickness in People Suffering From Migraines?
Condition: Migraine
MeSH terms: Migraine Disorders; Motion Sickness
Study type: Interventional

Summary: 
      The purpose of this study is to determine if Rizatriptan, a migraine medication, lowers
      motion sickness in migraine sufferers.
    

Detailed description: 
      Migraine sufferers undergo vestibular tests and were excluded if there were clinically
      significant abnormalities. Following screening, there were 2 experimental visits in which
      migraine sufferers were pre-treated with either Rizatriptan or placebo. After taking the
      drug, subjects were idle for 2 hours. Baseline motion sickness and subjective units of
      distress levels were assessed prior to undergoing sinusoidal-earth-vertical earth axis
      rotation in darkness at 0.05 Hz. Scores were taken immediately after stopping. Subjects were
      given a 2 minutes rest and then underwent a motion sickness provoking rotation. Subjective
      scores were assessed immediately following. Another two minute rest was given and if the
      subject was able, underwent a second motion sickness provoking stimulus followed by an
      assessment.
    

Intervention name(s): Rizatriptan; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 10 mg Rizatriptan in an unlabeled pill given once on one of two visits; In an unlabeled pill given once on one of two visits.
Other intervention name(s): Maxalt; Sugar Pill
Intervention MeSH terms: Rizatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Migraine; Triptans; Motion Sickness
Open Label Pharmaco- Magnetic Resonance Spectrography (MRS) Study of Clavulanic Acid
Condition: Cocaine Dependence, in Remission; Cocaine Abuse, in Remission; Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine how the study drug, clavulanic acid, affects
      glutamate in the brain using Magnetic Resonance (MR/MRI) scans. In this study, subjects will
      receive the study drug, clavulanic acid and undergo 4 MRI scans. This is being studied to
      determine the correct dosing of clavulanic acid, and to gather data so future studies can be
      done to find out if this drug is helpful in treating cocaine dependence. Currently, there is
      no available medication treatment for cocaine dependence.
    


Intervention name(s): Clavulanic Acid
Intervention type(s): Drug
Intervention description(s): ~10 days of Clavulanic Acid
Intervention MeSH terms: Clavulanic Acids; Clavulanic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of SAR231893 (REGN668) in Healthy Japanese Adult Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      Assess the safety and tolerability of SAR231893 (REGN668) after ascending single subcutaneous
      (SC) doses in healthy Japanese adult male subjects

      Secondary Objectives:

      Assess the following parameters after ascending single SC doses in healthy Japanese adult
      male subjects

        -  The pharmacokinetics of SAR231893 (REGN668)

        -  The immunogenicity of SAR231893 (REGN668)

        -  Exploratory analyses of the pharmacodynamics of SAR231893 (REGN668)
    

Detailed description: 
      Total duration of the study period per subject is 11 weeks broken down as follows:

      Screening period = 2 to 21 days Treatment period = 57 days, including 1 treatment day
    

Intervention name(s): SAR231893 (REGN668); placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection; Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment