bioihbjkbjnl/mcl2 huggingface dataset:
Spironolactone Plus Metformin in Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The investigators examined whether a combined therapy with low-dose spironolactone plus
      metformin is more effective than metformin alone in 52 overweight/obese Polycystic Ovary
      Syndrome (PCOS) patients.
    

Detailed description: 
      In the present prospective, randomized study, we evaluated the efficacy of a combined therapy
      with metformin and low-dose spironolactone as compared to metformin alone on the clinical and
      endocrine-metabolic alterations of PCOS patients.
    

Intervention name(s): Metformin; Metformin plus Spironolactone
Intervention type(s): Drug; Drug
Intervention description(s): Metformin 850 mg twice a day for six months; Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day
Intervention MeSH terms: Metformin; Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; metformin; spironolactone; metabolic syndrome; hyperandrogenism
A Study of M207 With Intranasal Zolmitriptan in Healthy Volunteers
Condition: Migraine
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, randomized, four-way crossover study. Each subject will
      receive each of the four study treatments once, followed by in-clinic monitoring and
      extensive blood sample collection for pharmacokinetic analysis.

      Dosing will occur approximately 48 hours apart, until completion of dosing in randomized
      order per the treatment sequence tables. Plasma samples from the dosing days will be sent to
      the analytical laboratory for analysis and tolerability for each of the dose levels will be
      summarized.

      After completion of the four dosing days, subjects will be assessed one final time and
      dismissed from the study.
    

Detailed description: 
      This is a single-center, open-label, randomized, four-way crossover study to compare the
      pharmacokinetics, safety and tolerability of:

      M207 3.8 mg administered to the upper arm to M207 3.8 mg administered to the thigh,
      particularly with respect to skin irritation (erythema, edema, bruising, bleeding):

      M207 3.8 mg worn for 30 minutes on the upper arm to M207 3.8 mg worn for 1 hour on the upper
      arm; and M207 3.8 mg to intranasal zolmitriptan 2.5 mg.

      Each subject will receive each of the four study treatments once, followed by in-clinic
      monitoring and extensive blood sample collection for pharmacokinetic analysis.

      M207 application sites will be observed for erythema, edema, bruising, and bleeding at
      various timepoints throughout the study.

      Dosing will occur approximately 48 hours apart, until completion of dosing in randomized
      order per the treatment sequence tables. Plasma samples from the dosing days will be sent to
      the analytical laboratory for analysis and tolerability for each of the dose levels will be
      summarized.

      After completion of the four dosing days, subjects will be assessed one final time and
      dismissed from the study.
    

Intervention name(s): A: M207 3.8mg, 30 min, upper arm; B: M207 3.8 mg, 30 min, thigh; C: M207 3.8 mg, 1 hr, upper arm; D:zolmitriptan nasal spray
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application); B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application); C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application); D: 2.5 mg/0.1 mL intranasal zolmitriptan
Other intervention name(s): A: Zolmitriptan patch, 3.8 mg, 30 min, upper arm; B: Zolmitriptan patch 3.8 mg, 30 min, thigh; C: Zolmitriptan patch, 3.8 mg, 1 hour, upper arm; Zomig Nasal Spray
Intervention MeSH terms: Oxazolidinones; Zolmitriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, open-label four-way crossover
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Volunteer; Pharmacokinetics
Prevalence of Obstructive Sleep Apnea Syndrome in Type 1 Diabetic Patients Treated With Insulin Pump (At1Home)
Condition: Type 1 Diabetes
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      Patients with type 1 diabetes have poorer glycemic control that could lead to macrovascular
      or neuropathic complications; in addition to an optimal treatment, prevention of diabetes
      complications requires to control associated risk factors, such as hypertension or
      dyslipidemia. Sleep apnea syndrome is a public health problem due to its high prevalence and
      marked morbidity and mortality, one increasingly interesting aspect is its relationship with
      metabolic disorders, specifically diabetes.Obstructive sleep apnea syndrome seems to be
      underestimated in this population. In this context, it appears to be important to estimate
      the prevalence of sleep respiratory diseases in patients with type 1 diabetes.
    


Intervention name(s): Diagnosis of sleep apnea by oxymetry
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type 1 patients treated by Insulin Pump.
      
Keywords: Obstructive Sleep Apnea Syndrome
Pilot Trial of Ustekinumab for Primary Sjögren's Syndrome
Condition: Primary Sjögren Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot study will make a preliminary determination of the safety of ustekinumab in
      patients with Primary Sjogren's Syndrome (PSS) and assess the response of systemic measures
      of inflammation (biomarkers).
    

Detailed description: 
      This is a single-center, open label, pilot trial of ustekinumab in patients with Primary
      Sjögren's Syndrome (PSS). Up to 15 subjects will receive an infusion loading dose of 6 mg/kg
      of ustekinumab at baseline, and 90 mg of ustekinumab subcutaneously at week 4, week 12 and
      week 20. Subjects will be followed for 24 weeks.
    

Intervention name(s): Ustekinumab
Intervention type(s): Drug
Intervention description(s): Up to 15 subjects will receive an infusion loading dose of 6 mg/kg of ustekinumab at baseline, and 90 mg of ustekinumab subcutaneously at week 4, week 12 and week 20. Subjects will be followed for 24 weeks.
Intervention MeSH terms: Ustekinumab
Intervention model: Single Group Assignment
Intervention model description: Up to 15 subjects will receive an infusion loading dose of 6 mg/kg of ustekinumab at baseline, and 90 mg of ustekinumab subcutaneously at week 4, week 12 and week 20. Subjects will be followed for 24 weeks.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary sjogren syndrome; PSS; SjS; Sjogren; Ustekinumab; SS
Efficacy of LAMA Added to ICS in Treatment of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the superiority of the glycopyrrolate bromide (CHF
      5259 pMDI) versus placebo on top of QVAR® pMDI, in terms of lung functions parameters, as
      well as to assess its safety.
    


Intervention name(s): CHF 5259 12.5 µg; CHF 5259 placebo
Intervention type(s): Drug; Drug
Intervention description(s): comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks; comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks
Other intervention name(s): glycopyrrolate bromide; Placebo
Intervention MeSH terms: Glycopyrrolate; Bromides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma, Anticholinergics
Assessment of Coronary Plaque Composition
Condition: Coronary Atherosclerosis; Endothelial Dysfunction; Coronary Small Vessel Disease
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators' hypothesis is that local activation of the endogenous
      Lipoprotein-associated phospholipase A2 (Lp-PLA2) plays an integral role in early
      atherosclerosis, and contributes to the mechanism of coronary endothelial dysfunction and to
      the structural and mechanical properties that characterize plaque vulnerability. Thus, this
      study will characterize prospectively the correlation between the functional and structural
      vascular wall properties, and the activity of the Lp-PLA2 pathway.
    

Detailed description: 
      The present study will be a substudy of our National Institute of Health (NIH) funded and
      Institutional Review Board (IRB) approved (08-008161) protocol "Lp-PLA2 and Coronary
      Atherosclerosis in Humans" and (10-000044) "Lp-PLA2 and Coronary Atherosclerosis in Humans
      Aim III" in which the investigators are examining the impact of long-term inhibition of
      Lp-PLA2, with a specific novel inhibitor, on Lp-PLA2 activity and improvement in coronary
      endothelial function.

      The substudy will allow the investigators to also examine the additional endpoint of lipid
      core content of atherosclerotic plaques and hence plaque vulnerability. Plaque lipid
      composition will be measured using the LipiScan or LipiScan IVUS catheter (InfraReDx Near
      Infrared Spectroscopy (NIRS) System with or without intravascular ultrasound (IVUS)
      capability) at baseline and again at 6 month following Lp-PLA2 inhibition.

      The study will provide insight into the role of the endogenous Lp-PLA2 in early coronary
      atherosclerosis, a potential therapeutic target for early coronary atherosclerosis in humans.
    

Intervention name(s): LipiScan/LipiScan IVUS
Intervention type(s): Device
Intervention description(s): Evaluation of the coronary artery using near infrared spectroscopy using either a LipiScan catheter or a LipiScan/IVUS catheter following a clinically indicated coronary angiogram and endothelial function testing with a positive diagnosis of endothelial dysfunction. The procedure is repeated following 6 months of Lp-PLA2 inhibition.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: atherosclerosis; endothelial dysfunction; coronary vasospasm
Identification of Biometric Marker(s) Capable of Detecting Early Prediabetes: Clinical Trial 1
Condition: Healthy
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The proposed clinical trial is a controlled study of n=24 healthy adult individuals tested in
      both the Meal-Induced Insulin Sensitization (MIS) state and, following atropine blockade,
      Absence of Meal-Induced Insulin Sensitization (AMIS) state to differentiate the postprandial
      glycemia, insulinemia, triglyceride and Hepatic Insulin Sensitizing Substance (HISS) levels
      in the two states.

      The purpose of this study is the identification and development of biometric markers which
      incorporate the actions and interplay between insulin and HISS. Overall, the study aims to:

        1. Utilize a standardized test meal to detect one of the earliest pathologies present
           during the development of insulin resistance, pre-diabetes and obesity.

        2. Compare the control (HISS positive) and post-atropine (HISS negative) tests with the
           acute consequences of absence of MIS (AMIS) being graphically shown over 4 hours of
           postprandial nutrient partitioning, tracking the full metabolomic dynamic pattern.

        3. To establish values for potential indices (bio-impedance, hand-grip strength,
           spirometry) in young, fit, lean individuals. These values will be used as baselines for
           comparative analysis in future clinical trials employing individuals with various
           degrees of insulin resistance to full Type 2 Diabetes.

        4. Demonstrate that these biometric markers can differentiate between the HISS positive and
           HISS negative post-meal state with the future aim of using the biomarkers for the
           detection of early prediabetes.

      The study will involve 4 study visits: Visit 1 - Prescreening; Visit 2 - Screening; Visit 3 -
      Liquid test meal administration and postprandial blood collection; Visit 4 - Atropine
      administration + Liquid test meal administration and postprandial blood collection.
    


Intervention name(s): Standardized liquid test meal; Atropine + Standardized liquid test meal
Intervention type(s): Other; Drug
Intervention description(s): During this study visit, a standardized liquid test meal will be administered. Blood samples will be collected at baseline and then every 30 minutes for 4 hours after test meal.; During this study visit, 1.0 mg atropine will be administered I.V and then a standardized liquid test meal will be administered. Blood samples will be collected at baseline, following atropine administration, and then every 30 minutes for 4 hours after test meal.
Intervention MeSH terms: Atropine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Glucose; Insulin; Prediabetes
Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain
Condition: Chronic or Recurrent Appendicitis
MeSH terms: Appendicitis; Abdominal Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      It is questionable whether elective appendectomy can effectively reduce pain in persistent or
      recurrent lower abdominal quadrant pain due to chronic appendicitis.

      A single centre randomised double-blind sham surgery controlled clinical trial studied the
      effects of elective laparoscopic appendectomy on postoperative pain perception in patients
      with persistent or recurrent lower abdominal quadrant pain on abdominal pain at 6 months
      postoperatively. Secondary outcome was the relation between clinical response and the
      appendix' histopathology. The analysis was performed on an intention-to-treat basis. Pain
      scores were compared using a Fisher's exact test.
    

Detailed description: 
      Forty patients were randomised, 18 patients had a laparoscopic appendectomy and 22 patients
      had a laparoscopic inspection only. The postoperative pain scores were significantly
      different favouring appendix removal (p < 0.01). Relative risk calculations indicated a 2.4
      fold (95% CI: 1.3 - 4.0) greater chance of improving or becoming pain free after laparoscopic
      appendectomy. The number needed to treat was 2.2 patients (95% CI: 1.5 - 6.5). There was no
      significant relation between postoperative pain scores and histopathology findings.

      Conclusions Chronic or recurrent appendicitis is a realistic clinical entity that can be
      treated successfully by elective appendectomy leading to significant pain reduction in
      properly selected cases. Histopathology of the removed appendix does not contribute to the
      diagnosis.
    

Intervention name(s): laparoscopic appendectomy or not (surgery)
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Abdominal pain; Appendectomy; Laparoscopy; Chronic appendicitis; Appendicopathy
Polyphenols, Exercise, and Metabolomics
Condition: Exercise-induced Inflammation; Exercise-induced Oxidative Stress; Exercise-induced Immune Dysfunction
MeSH terms: Immune System Diseases; Inflammation
Study type: Interventional

Summary: 
      Nutrasorb is a newly developed food product (see www.nutrasorb.com). This study will use the
      Nutrasorb soy protein product that is matrixed with polyphenols from blueberries and green
      tea extract, and test for efficacy as a nutritional countermeasure to exercise-induced
      physiologic stress (i.e., immune dysfunction, inflammation, and oxidative stress) using both
      traditional and metabolomics-based outcome measures.
    


Intervention name(s): Nutrasorb; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): from blueberry and green tea extracts (2,136 mg/d gallic acid equivalents)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Inflammation; Oxidative stress; Immune dysfunction; Metabolomics.
Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria
Condition: Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the safety and efficacy in children aged 6 - 59
      months with uncomplicated malaria, treated with either conventional artemether/lumefantrine
      tablets(Coartem®) or artemether/ lumefantrine suspension (Co-artesiane®) in Western Kenya
    


Intervention name(s): Artemether/lumefantrine tablets; Artemether/Lumefantrine suspension
Intervention type(s): Drug; Drug
Intervention description(s): Artemether/lumefantrine tablets containing 20mg artemether and 120mg lumefantrine
Dosage: 5 - 14.9 kg: 1 tablet and 15 - 24.9 kg: 2 tablets
Administered at 0, 8, 24, 36, 48, and 60 hours on days 0, 1, and 2; Artemether/lumefantrine suspension containing 15mg artemether and 90mg lumefantrine per 5ml suspension
Dosage: 5.0 - 7.4 kg = 7 ml, 7.5 - 9.9 kg = 10 ml, 10 - 12.4 kg = 14 ml, 12.5 - 14.9 kg = 17 ml, 15 - 17.4 kg = 20 ml, 17.5 - 19.9 kg = 24 ml, 20 - 22.4 kg = 27 ml and 22.5 - 24.9 kg = 30 ml
Administered once daily at 0, 24, and 48 hours on days 0, 1 and 2
Other intervention name(s): Coartem; Co-Artesiane suspension
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artemether/Lumefantrine suspension; P. falciparum malaria; children; uncomplicated Plasmodium falciparum malaria
Botulinum-assisted Orbital Fat Augmentation With PRP (Platelet-rich-plasma)
Condition: Orbital Atrophy
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      immobilization of yoked extra-ocular muscles in the anophthalmic orbit, in conjunction with
      platelet-rich-plasma, will improve integration of viable adipocytes injected into orbital fat
    

Detailed description: 
      Immobilization of tissue (graft, graft bed) is a prerequisite for tissue integration. Since
      yoked extra-ocular muscles continue to be stimulated by movements of the seeing eye after fat
      injection into the anophthalmic orbit, the use of botulinum toxin(s) can be used to prevent
      movement of the orbital tissue bed(s) and improve anchoring of injected fat. Platelet rich
      plasma may also improve fat cell anchoring by the action of fibrin on the adhesion process.
      This innovation builds on the results of IRB protocols 10.27 and 12.01 as registered with
      Clinical Trials.gov
    

Intervention name(s): fat, PRP, botulinum toxin; botulinum toxin; PRP
Intervention type(s): Procedure; Drug; Device
Intervention description(s): fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin; botulinum toxin used to immobilize extra-ocular muscles prior to fat injection.; autologous PRP is prepared with a dedicated centrifuge at the time of fat harvesting
Other intervention name(s): fat atrophy, absence of original eye, phthisis bulbi; botulinum toxins; platelet rich plasma
Intervention MeSH terms: Botulinum Toxins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to determine the efficacy, dose response, and safety of M52951
      in participants with Rheumatoid Arthritis (RA), and to consider a dose to took forward into
      Phase III development.
    


Intervention name(s): M2591 25 mg QD; M2951 75 mg QD; M2951 50 mg BID; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 12 weeks.; Participants received 75 mg of M2951 orally QD for 12 weeks.; Participants received 50 mg of M2951 orally twice daily (BID) for 12 weeks.; Participants received placebo matched to M2951 orally for 12 weeks.
Other intervention name(s): Evobrutinib; Evobrutinib; Evobrutinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; American College of Rheumatology; High-sensitivity C-reactive protein; Bruton's tyrosine kinase
SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study
Condition: Eosinophilic Gastrointestinal Disorders (EGIDs); Eosinophilic Esophagitis (EoE)
MeSH terms: Esophagitis; Eosinophilic Esophagitis; Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this interventional study is to test and compare the effectiveness of two
      elimination diets-the 1-food elimination diet (1FED, milk only) and the 6-food elimination
      diet (6FED, milk, egg, wheat, soy, tree nut/peanuts, and fish/shellfish). The study will also
      test the effectiveness of swallowed glucocorticoid therapy in some of the study participants
      for whom diet therapy was not effective.
    

Detailed description: 
      This study will consist of two phases, plus a screening period. During the screening period,
      subject eligibility for the study will be determined. During Phase 1, qualified participants
      will be randomly assigned to one of two elimination diet therapies--the 1FED or the 6FED.
      Participants will remain on the assigned dietary therapy for 6 weeks. At the end of 6 weeks
      of therapy, esophageal biopsies from participant's standard of care (i.e. normal, routine
      care) endoscopy will be evaluated to determine disease status. Participants whose EoE is in
      remission (i.e. <15 eos/hpf) will be done with the study.

      Participants whose EoE is still active (i.e. ≥15 eos/hpf) will have the option to continue
      into Phase 2 of the study. During Phase 2, participants who were on 1FED in Phase 1 will
      receive 6FED therapy for 6 weeks, and participants who were on 6FED during Phase 1 will
      receive swallowed glucocorticoid (SGC) therapy for 6 weeks. At the end of 6 weeks of therapy,
      esophageal biopsies from participant's standard of care (i.e. normal, routine care) endoscopy
      will be evaluated to determine disease status.
    

Intervention name(s): 1 Food Elimination Diet Therapy; 6 Food Elimination Diet Therapy; 6 Food Elimination Diet (after 1FED failure); Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)
Intervention type(s): Other; Other; Other; Drug
Other intervention name(s): Flovent HFA
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment