bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and
      tolerability of vismodegib in combination with pirfenidone in participants with idiopathic
      pulmonary fibrosis (IPF) currently being treated with pirfenidone.
    


Intervention name(s): Pirfenidone; Vismodegib
Intervention type(s): Drug; Drug
Intervention description(s): Pirfenidone will be administered as per the dosage schedule mentioned in arm description.; Vismodegib will be administered as per the dosage schedule mentioned in arm description.
Other intervention name(s): RO0220912; RO5450815
Intervention MeSH terms: Pirfenidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Idiopathic Pulmonary Fibrosis; Vismodegib; Pirfenidone
Trial of Juvista (Avotermin) Following Removal of Ear Lobe Keloid Scars
Condition: Keloid
MeSH terms: Keloid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This trial will assess the safety and efficacy of 50 and 200ng Juvista per linear cm of wound
      margin administered by intradermal injection following the excision of keloid scars on the
      ear lobe. Ear lobe keloids commonly occur after ear piercing and can be particularly
      distressing for patients as they are very difficult to conceal and are usually bilateral. As
      the recurrence rate and growth rate of keloids can vary significantly between individuals,
      trial subjects will have bilateral ear lobe keloids and will act as their own control. One
      ear lobe will be treated with Juvista following keloid excision and one with placebo.
    


Intervention name(s): Avotermin
Intervention type(s): Drug
Intervention description(s): 10 patients:- 50ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure.
10 Patients:- 200ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Search for Helicobacter Pylori in Localized Vulvodynia
Condition: Vulvodynia; Vulvar Vestibulitis
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Observational

Summary: 
      Hypothesis: to examine a possible association between localized vulvodynia and H. pylori
      infection.
    

Detailed description: 
      Subsequent sections from the paraffin blocks were prepared and stained by modified Giemsa.
      Immunostaining for H. pylori was done as described. In short, tissue sections were
      deparaffinized in xylene, rehydrated through decreasing concentrations of alcohol ending in
      phosphate-buffered saline (PBS), and subjected to pretreatment with Proteinase K (8 minutes).
      The sections were quenched with 3% hydrogen peroxidase, incubated with protein block for 15
      minutes at room temperature, and washed in PBS. Tissues then were incubated with polyclonal
      rabbit anti-H pylori antibody (dilution, 1:10; clone ch-20 429, DAKO, Carpinteria, CA).
      Finally, sections were washed in 0.05% polysorbate 20 in PBS, pH 7.4, and the bound antibody
      was detected using streptavidin and biotinylated secondary antibody with diaminobenzidine as
      the chromogen. Sections were counterstained with hematoxylin, dehydrated, and mounted.
      Negative controls were sections treated as above, but instead of incubation with the primary
      antibody, they were incubated with 1% bovine serum albumin in PBS.

      Vulvar biopsies of seven other women without localized vulvodynia served as healthy controls.

      The positive and negative control gastric tissues for the immunohistochemical stain of the H.
      pylori microorganisms were obtained from the archives of the Department of Pathology.
    

Observational model: Case-Control
Time perspective: Other
Keywords: Localized vulvodynia; Helicobacter pylori; peptic disease; omeprazole
Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the
      pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin
      30/70 PreMix in healthy volunteers.
    


Intervention name(s): biphasic insulin aspart 30; biphasic human insulin 30
Intervention type(s): Drug; Drug
Intervention description(s): One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order; One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Duration of Immune Response to Influenza Vaccination in Patients With RA
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective is to evaluate the strength and duration of immune response after
      influenza vaccination in patients with Rheumatoid Arthritis (RA) receiving treatment with
      biological agents as compared to a group healthy controls who do not have RA. Influenza
      vaccine titers will be drawn 3 times: at Baseline(prior to vaccination), 4-6 weeks post
      vaccination, and 5-6 months post vaccination. Influenza vaccination will be done at the
      baseline visit after the baseline blood draw.
    

Detailed description: 
      Aims:

        -  Evaluate the strength and duration of immune response after influenza vaccination in
           patients with Rheumatoid Arthritis (RA) receiving treatment with biological agents.

        -  Evaluate for predictors of immune response such as age, gender, disease duration, type
           of the biological agent(s) used, duration of the treatment, and type of treatment in the
           past.

        -  Assess the efficacy of vaccine response in this population by recording proportion of
           patients who contracted influenza illness despite vaccination. The result of the study
           may provide more information regarding which situations inadequate immune response by
           strength or duration would most likely to be expected. This may help lay some groundwork
           for future studies looking at the use of booster vaccinations in this population
    

Intervention name(s): Influenza vaccine
Intervention type(s): Biological
Intervention description(s): Each participant will have a blood draw to measure the antibody titres influenza strains covered by the 2014-2015 influenza vaccine at three different time points:
Visit 1- Baseline/prior to vaccination Visit 2- 4-6 weeks post-vaccination Visit 3- end of influenza season (April-May)
At Visit 1, after the baseline blood draw, all participants will be vaccinated by Research staff in order to standardize the time from Baseline blood draw to vaccination. Participants aged 65 and older will be offered the extra strength version of the vaccine, which is usual care. Participants under the age of 65 will be given the usual strength vaccine. All patients will be given the intramuscular (IM) vaccine.
Other intervention name(s): Fluzone; Fluzone High Dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of
      several blood thinner drugs on laboratory tests. The study also is evaluating the blood
      levels of PRT064445 given at different doses.
    

Detailed description: 
      A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability,
      pharmacokinetics, and pharmacodynamics of intravenously administered PRT064445 after dosing
      to steady state with one of four direct/indirect fXa inhibitors in healthy volunteers
    

Intervention name(s): PRT064445/Apixaban; Placebo/Apixaban; Placebo
Intervention type(s): Combination Product; Combination Product; Drug
Other intervention name(s): Andexanet
Intervention MeSH terms: Apixaban
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study has four modules with a total of 21 cohorts, each module was reported and submitted separately.
Module 1, NCT01758432 (54 subjects with 7cohorts including placebo); Module 2, NCT03578146 (48 subjects with 6 cohorts including placebo); Module 3, NCT03551730 (27 subjects with 4 cohorts including placebo); Module 4, NCT03551743 (28 subjects with 4 cohorts including placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy volunteers
A Study to Evaluate and Compare Injections of Autologous Dermal Cells Into the Balding Scalp of Subjects With Hair Loss
Condition: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the ability of Ji Gami(TM) DO to induce hair growth in male and female subjects with
      hair loss.
    


Intervention name(s): Autologous cultured dermal cells
Intervention type(s): Biological
Intervention description(s): A piece of occipital scalp is taken from the subject. The dermal cells from this tissue are expanded in culture. The cells are then harvested. These cells are then injected into the balding area of the scalp of the original subject.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness; Hair Loss; Baldness
Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy of a low and high dose of a budesonide
      effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction
      treatment of active eosinophilic esophagitis.
    


Intervention name(s): low dose budesonide tablet; high dose budesonide tablet; high dose budesonide suspension; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1mg budesonide tablet twice daily AND 5ml placebo suspension twice daily; 2mg budesonide tablet twice daily AND 5ml placebo suspension twice daily; placebo tablet twice daily AND 5ml [0.4mg budesonide/ml] suspension twice daily; placebo tablet twice daily AND 5ml placebo suspension twice daily
Other intervention name(s): BET 1mg BID; BET 2mg BID; BVS 2mg BID
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Personalized Management of Body Weight During Pregnancy
Condition: Weight Gain During Pregnancy
MeSH terms: Body Weight; Weight Gain
Study type: Interventional

Summary: 
      The purpose of this study is to determine how to help manage weight gain during pregnancy.
      This study is part of the National Consortium 'LIFE-Moms: Lifestyle interventions in
      expectant moms'. LIFE-Moms is 7 studies funded to test different lifestyle interventions in
      overweight and obese pregnant women.
    

Detailed description: 
      The study will last 22 months, from screening until study completion. The entire study will
      include 3 screening visits, receipt of weight management advice, second trimester testing,
      third trimester testing and three follow up visits during the first year after the baby is
      born. Participants will randomly be assigned to 1 of 3 programs to help manage their weight
      during pregnancy:

        1. Physician Directed group

        2. SmartMoms-Clinic group

        3. SmartMoms-Phone group
    

Intervention name(s): SmartMoms
Intervention type(s): Behavioral
Intervention description(s): This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnancy; Gestational weight gain
Corticotropin Stimulation in Adrenal Venous Sampling for Patients With Primary Aldosteronism(ADOPA)
Condition: Primary Aldosteronism
MeSH terms: Hyperaldosteronism
Study type: Interventional

Summary: 
      To compare the effect of different procedures of AVS(with or without ACTH stimulation) on the
      long-term outcomes of patients with PA
    

Detailed description: 
      This is a prospective and randomized study involving patients with primary aldosteronism(PA)
      who completed AVS.

      All paticipants will be randomized into ACTH-stimulated group(Intervention group) and
      ACTH-unstimulated group(Control group) Cannulation was considered successful when the
      selectivity index (SI), namely plasma cortisol concentration (PCC) in adrenal vein/PCC in
      IVC≥3 with ACTH stimulation or SI≥2 without ACTH stimulation. The ratio of PAC: PCC on the
      side with the higher ratio over the contralateral PAC: PCC ratio is defined as the
      lateralization index (LI). Lateralization of aldosterone excess was defined as LI≥4
      irrespective of ACTH use. Patients with LI between 2 and 4 together with contralateral
      suppression (PAC/PCC of non-dominant side < PAC/PCC of IVC) or CT showing a typical adenoma
      on the dominant side were also considered to have lateralized disease. Patients with LI < 2
      or LI 2-4 without meeting the above criteria were diagnosed as BPA.

      In case of technical AVS failure or bilateral PAC/PCC in adrenal venous blood lower than
      peripheral blood, if the patient meets one of the following criteria, adrenalectomy was
      recommended: 1) unilateral nodule on CT (≥ 1 cm), no observable nodules or hyperplasia on
      contralateral adrenal, and PAC ≥ 20 ng/dl, PRC < 5 μIU/ml, K ≤ 3.5mmol/l; 2) unilateral
      nodule on CT (≥ 1 cm), no observable nodules or hyperplasia on contralateral adrenal, and the
      contralateral index≤0.5 in AVS.

      Surgical intervention is recommended for unilateral PA (UPA) whereas bilateral PA (BPA) is
      typically treated with oral mineralocorticoid receptor antagonists such as spironolactone.
      The aim is to compare the long-term outcomes of patients with PA.

      To evaluate whether the treatment decision (surgical or medical treatment) based on different
      AVS procedures (with or without ACTH stimulation) would lead to different outcomes in
      patients with PA.
    

Intervention name(s): Adrenocorticotropic hormone
Intervention type(s): Drug
Intervention description(s): Patients divided into Intervention group need to undergo stimulation with a continuous cosyntropin infusion (50 μg/h started 30 minutes before sampling during AVS). Right and left adrenal venous blood and corresponding peripheral venous blood should be sampled sequentially.
Other intervention name(s): ACTH
Intervention MeSH terms: Hormones; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: primary aldosteronism; adrenal venous sampling; adrenocorticotropic hormone
Impact of Myofuntional Therapy Program on Increasing Tongue Strength and Improving Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      This Research studies for compare muscle strength among OSA patients who treat with
      myofunctional therapy program in Rajavithi hospital
    


Intervention name(s): myofunctional therapy program
Intervention type(s): Other
Intervention description(s): Exercise oral cavity muscle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myofunctional therapy; IOPI; Obstructive sleep apnea (OSA)
Regulation of Fat-stimulated Neurotensin Secretion in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      Context: Cholecystokinin (CCK) and neurotensin are stimulated during meal intake by the
      presence of fat in the small intestine. The sequence of events suggests that fat hydrolysis
      is crucial for triggering the release.

      Objectives: The aim of this study was therefore to investigate whether CCK mediated the
      effect of intraduodenal (ID) fat on neurotensin secretion via CCK-1 receptors.
    

Detailed description: 
      Setting: Single center study; 34 male volunteers were studied in consecutive, randomized,
      double blind, crossover studies.

      Subjects and Methods: CCK and neurotensin release were quantified in: 1) 12 subjects
      receiving an ID fat infusion with or without 60 mg orlistat, an irreversible inhibitor of
      gastrointestinal lipases, in comparison to vehicle. 2) 12 subjects receiving ID long chain
      fatty acids (LCF), ID medium chain fatty acids (MCF) or ID vehicle. 3) 10 subjects receiving
      ID LCF with and without the CCK-1 receptor antagonist dexloxiglumide (DEXLOX) or ID vehicle
      plus IV saline (placebo). Hormone concentrations were measured by specific RIA systems.
    

Intervention name(s): Fat perfusion to the small intestine
Intervention type(s): Dietary Supplement
Intervention description(s): Triglycerides, long chain fatty acids, medium chain fatty acids perfused to the small intestine
Orlistat perfused to the small intestine
DEXLOX as CCK-1 receptor antagonist
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Neurotensin; Human; Physiology of neurotensin; fat perfusion; healthy subjects
Pain Free Laceration Repairs Using Intra-nasal Ketamine
Condition: Laceration
MeSH terms: Lacerations
Study type: Interventional
Phase: Phase 2

Summary: 
      Lacerations are one of most common trauma in children presenting to the emergency department
      (ED). Currently, there are wide variations regarding sedation and analgesia practices when
      suture are required. Even though topical anesthesia is very useful to reduce pain, it does
      not obviate the use of pharmacologic agents to decrease stress in anxious children undergoing
      laceration repairs in the ED.

      There is a growing interest in the intranasal (IN) route of administration in the pediatric
      population. It bypasses the first hepatic passage and thus provides medications direct access
      to the systemic circulation leading to higher and faster serum concentrations than would the
      oral route. Also, intravenous (IV) cannulation can be avoided reducing the pain associated
      with it and the need for nursing time and procedure delay. IN fentanyl and midazolam are two
      agents that can be combined for this procedure, but respiratory depression is a feared
      adverse effects. Ketamine is the most commonly used IV agent for procedural sedation, and can
      offer potent analgesia and sedation while maintaining respiratory drive and protective airway
      reflexes. Few studies have evaluated IN ketamine for procedural sedation. There is a wide
      range of dosing reported from 3 to 9 mg/kg. This raises the question as what is the lowest
      possible dosage that can be used to successfully repairs laceration in children with minimal
      restrain and no adverse events, as described by the Pediatric Emergency Research Canada
      (PERC)/ Pediatric Emergency Care Applied Research Network (PECARN) consensus.
    


Intervention name(s): Intranasal Ketamine
Intervention type(s): Drug
Intervention description(s): Administration of intranasal ketamine at a dose from 3 to 9 mg/kg for safe and effective procedural sedation for laceration repair in the ED for children aged 1 to 12 year-old.
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intranasal Ketamine; Pain Management
Medication Development in Alcoholism: Investigating PPAR Agonists
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary hypotheses under test are that alcohol dependent subjects treated with
      fenofibrate will report decreased craving for alcohol following cue-exposure in the
      laboratory and report less drinking post treatment relative to placebo.
    


Intervention name(s): Sugar Pill; TRICOR (fenofibrate)
Intervention type(s): Drug; Drug
Intervention description(s): 145 mg/day, oral pill, 9 days; 145 mg/day, oral pill, 9 days
Other intervention name(s): Fenofibrate; Fenoglide; Trilipix; Lipofen
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Alcohol; Relapse