bioihbjkbjnl/mcl2 huggingface dataset:
To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      To examine the lung when people with diabetes take an inhaled form of insulin, compared to
      subcutaneous insulin.
    


Intervention name(s): Inhaled insulin
Intervention type(s): Drug
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns,
      HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of
      insulin glargine and exenatide to metformin.
    

Detailed description: 
      The primary objective of this study was to characterize the diurnal glucose patterns produced
      by insulin glargine alone, exenatide (GLP-1 agonist) alone and the combination of insulin
      glargine and exenatide in subjects taking stable dose of metformin and to evaluate their
      efficacy in terms of improvement in glucose exposure, variability, stability, incidence of
      hypoglycemia and weight management.

      An ancillary study was approved as part of this study. The purpose of the ancillary study was
      to use CGM to characterize the glycemic response to a fixed breakfast meal consumed by study
      participants receiving different medications.
    

Intervention name(s): Exenatide; Insulin Glargine
Intervention type(s): Drug; Drug
Intervention description(s): 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study; .1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
Other intervention name(s): Bydureon; Lantus
Intervention MeSH terms: Insulin Glargine; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; continuous glucose monitoring; exenatide; insulin glargine
A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression
Condition: Depression; Depressive Disorder; Depression, Postpartum; Behavioral Symptoms; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Postpartum; PPD
MeSH terms: Depression, Postpartum; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Mental Disorders; Mood Disorders; Behavioral Symptoms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of
      Ganaxolone in Women with Postpartum Depression
    

Detailed description: 
      This study will explore whether ganaxolone is safe and well tolerated in women suffering from
      PPD. In addition, ganaxolone's efficacy in treating depressive symptoms will be assessed
      through a set of exploratory analyses. Plasma levels of ganaxolone will be determined through
      pharmacokinetic analysis. The study results will be used to select a ganaxolone dose and
      dosing regimen for further development in PPD.
    

Intervention name(s): Ganaxolone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ganaxolone IV; Placebo IV
Intervention MeSH terms: Ganaxolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postpartum Care; Postpartum Depression
Lipids and Insulin Sensitivity
Condition: Obesity; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Rationale: The investigators hypothesize that a change in dietary fat quality (an increase in
      unsaturated fatty acids) may modulate fuel partitioning within the type 2 diabetic muscle
      towards less accumulation of lipid metabolites and an improved insulin sensitivity.

      Objective:

        1. The contribution of dietary vs endogenous fat sources to lipid overflow in the
           circulation and to skeletal muscle lipid uptake and storage in obese insulin resistant
           subjects vs obese insulin sensitive controls.

        2. The acute effect of meals with various fatty acid composition ((high saturated (SFA) vs
           polyunsaturated (PUFA) vs monounsaturated (MUFA)) on skeletal muscle lipid uptake and
           storage, fatty acid mediated gene expression and postprandial insulin sensitivity in
           obese insulin resistant subjects.

      Study design: single-blind randomized cross-over trial

      Study population: obese males (35-70 years) with or without insulin resistance

      Intervention:

        1. 1 test meal

        2. 3 test meals with a different fatty acid composition

      Main study parameters/endpoints:

      More insight whether dietary fat quality may modulate circulating lipids and skeletal muscle
      fatty acids handling, and may affect oxidative capacity and lipid storage in parallel to an
      increased insulin sensitivity.
    


Intervention name(s): test meals with various fatty acid compositions
Intervention type(s): Dietary Supplement
Intervention description(s): Three different milkshakes with a U13C palmitate tracer added
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Lipid metabolism
Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone
      mineral density (bone strength).
    


Intervention name(s): Arzoxifene; Raloxifene
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg, oral, tablet, once a day for 52 weeks; 60 mg, oral, tablet, once a day for 52 weeks
Other intervention name(s): LY353381; LY139481; Evista
Intervention MeSH terms: Raloxifene Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Aneuploidies and Different Stimulation Protocols
Condition: Aneuploidy
MeSH terms: Aneuploidy
Study type: Interventional

Summary: 
      Our working hypothesis is that patients undergoing "in vitro" fertilization (IVF) with higher
      response to ovarian stimulation protocols recover a higher number of oocytes and, this
      elevated response could be translated into increased incidence of chromosomally abnormal
      embryos. Our objective is to develop a prospective study on healthy young donors, with a
      previous cycle with high ovarian response (>20 oocytes and/or E2 levels the day of the hCG
      injection >3000 pg/mL), but without developing mild or severe hyperstimulation syndrome.
      After signing a proper written consent, these donors would agree to undergo two subsequent
      stimulation cycles following two different protocols. In one cycle the stimulation pattern
      would be similar to the previous one, with elevated response and, in another cycle the amount
      of gonadotropins would be cut down in order to obtain lower ovarian response. Oocytes
      obtained in each cycle would be donated to anonymous recipients and after fertilization,
      embryo quality and chromosomal status of the resulting embryos would be evaluated.
      Preimplantation genetic diagnosis (PGD) will be performed on day-3 embryos and chromosomes
      13, 15, 16, 17, 18, 21, 22, X and Y would be analyzed by fluorescence "in situ" hybridization
      (FISH).
    


Intervention name(s): Gonadotrophins; Low dosis Gonadotrophin
Intervention type(s): Drug; Drug
Intervention description(s): Administration of standard ovarian stimulation protocol
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Ovarian; hyperstimulation; Embryo; Aneuploidy; Ovarian hyperstimulation and Embryo Aneuploidy Rates
Smartphone and Posture Control In Healthy Adolescents
Condition: Balance
Study type: Observational

Summary: 
      This is a study to determine if smartphone use affect posture control in adolescents.
    

Detailed description: 
      It is within subject repeated measure study to determine if touch screen use affect posture
      control in healthy adolescents.

      200 normal adolescents between 14 and 18 years old will be included.

      1st they will be assessed for posture control to determine normal values for their ages, then
      each child will be given smartphone to play a game while the sound is muted for 15 min then
      their balance will be re-assessed, finally they will use the phone for another 15 min but the
      children will use headphone piece this time then re-assess balance.
    

Intervention name(s): smartphone
Intervention type(s): Device
Intervention description(s): modern technology
Other intervention name(s): touch screen
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Normal Adolescents
An Optional Two Year Follow Up Study to Study CP005A
Condition: Cat Allergy; Rhinoconjunctivitis
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Cat allergy is an increasingly prevalent condition affecting 10-15% of patients with allergic
      rhinoconjunctivitis and/or asthma.

      The purpose of this optional observational follow-on study is to further evaluate
      rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who
      completed all dosing visits in study CP005 and all visits in study CP005A approximately two
      years after the start of treatment.
    

Detailed description: 
      Subjects who completed all visits in studies CP005 and CP005A will be invited to attend the
      Screening Visit for CP005B. Subjects will attend for 4 visits to the EEC on successive days.
      Following the last EEC visit is a follow-up visit which will be performed 3-10 days later.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects previously randomised in study CP005 and completed all dosing and PTC in CP005 and
        all visits in CP005A.
      
Keywords: Cat Allergy; Rhinoconjunctivitis
Safety Study of Ibuprofen to Treat Acute Traumatic Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The Ibuprofen - Spinal Cord Injury (SCI) - Safety trial investigates tolerability and
      feasibility of "small molecule" (Ibuprofen) mediated Rho-inhibition as putative
      neuroprotective, plasticity-enhancing and neurorestaurative intervention. The primary safety
      analysis is based on the incidence of severe gastrointestinal bleedings. In addition, the
      feasibility of recruitment procedure, and oral administration of the compound within the
      multidisciplinary setting of acute intensive medical care will be explored. Furthermore, the
      pharmacokinetics of Ibuprofen under the condition of acute motor complete SCI will be
      investigated. Secondary endpoints will permit preliminary statements about effects on
      neuropathic pain, spasticity, and neurological function.
    


Intervention name(s): Dolormin® extra (Ibuprofen); Dolormin® extra (Ibuprofen)
Intervention type(s): Drug; Drug
Intervention description(s): Ibuprofen Tablets (as lysine-salt) 2400mg/d (400mg 2-2-2) applied orally for 4 weeks (Arm I; n=6).
In order to reduce the risk of damage to the gastrointestinal mucosa Pantoprazole is applied as concomitant medication in a dosage 40mg/d during the treatment period.; Ibuprofen Tablets (as lysine-salt) 2400mg/d (400mg 2-2-2) applied orally for 12 weeks (Arm II, n=6).
In order to reduce the risk of damage to the gastrointestinal mucosa Pantoprazole is applied as concomitant medication in a dosage 40mg/d during the first 4 weeks of treatment and may be reduced to 20mg/d during the following treatment period after individual risk-benefit assessment.
Other intervention name(s): Ibuprofen-DL-Lysinsalz; Ibuprofen-DL-Lysinsalz
Intervention MeSH terms: Ibuprofen
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rho-Inhibition; Plasticity; Neurological Function; RhoA; Ibuprofen; NSAIDs
Effect of 4 Weeks of Citrulline and Glutathione Supplementation on Arterial Function
Condition: Menopause; Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      Examining the effects of 4 weeks of Citrulline alone or in combination with glutathione on
      the arterial function of postmenopausal women.
    

Detailed description: 
      L-Citrulline is a non-protein amino acid and an efficient precursor of L-arginine, the
      substrate for endothelial nitric oxide synthesis. Glutathione is a tripeptide with
      antioxidant effects. Postmenopausal women will ingest 6g/d of L-Citrulline or 2g of
      L-Citrulline plus 200mg/d of glutathione or placebo (maltodextrin) for 4 weeks with vascular
      function testing prior to and after the intervention.
    

Intervention name(s): L-Citrulline; L-Citrulline; Placebo; Glutathione
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Four weeks of oral L-Citrulline (2 grams/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.; Four weeks of oral L-Citrulline (6 grams/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.; Four weeks of oral placebo (6 grams/day maltodextrin) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.; Four weeks of Glutathione (200mg/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator)
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Endothelial Function; Aortic Hemodynamics; Pressure Wave Reflection
Wear Your Mask, Wash Your Hands, Don't Get COVID-19
Condition: Coronavirus; Child, Only
MeSH terms: Coronavirus Infections
Study type: Interventional

Summary: 
      The aim of this project is to determine the effect of training given to children aged 11-14
      on hand hygiene and mask use. In line with this general purpose, the hypotheses of the
      research are as follows:

      H0= Education given to children aged 11-14 on hand hygiene and mask use has no effect on
      children's hand hygiene and mask use behaviors.

      H1= With the education given to children aged 11-14 on hand hygiene and mask use, children
      will exhibit more correct hand hygiene and mask use behaviors.
    

Detailed description: 
      The universe of the research will consist of 273 secondary school students between the ages
      of 11-14 according to the education and training of Bartın Ertuğrul Gazi Secondary School.
      The children's inclusion criteria are as follows:

        -  Being between the ages of 11-14,

        -  Being a student of Bartın Ertuğrul Gazi Secondary School,

        -  The child and his parents agree to participate in the project,

        -  The child's speech and visual impairment do not have any handicap that would force or
           hinder communication.

      Intervention: Once enrolled and consent is documented, eligible subjects will participate in
      the study for approximately three months. Participants will be expected to attend 2 training
      sessions and 2 activities (wearing masks and hygienic hand washing), each is up to one hour
      in length. Follow-up will be made at the beginning of the training, right after the last
      training. Data analysis will begin once all trainings and activities have been completed.
      Investigators anticipate completing the study, including primary analyses, within six months
      from the date recruitment begins.
    

Intervention name(s): Training and activities
Intervention type(s): Other
Intervention description(s): The training program consists of two modules. The 1st module consists of a theoretical lecture (powerpoint presentation) and an activity (application of hygienic handwashing by the researcher) explaining what to do for hygienic handwashing. The 2nd module consists of the theoretical explanation (powerpoint presentation) in which the correct mask usage is explained and the activity (the "make your own mask" activity by painting the masks).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison of Breathing Exercise for Hypertensive Patients
Condition: Hypertension
MeSH terms: Respiratory Aspiration; Hypertension
Study type: Interventional

Summary: 
      To determine the Effectiveness of diaphragmatic breathing vs. slow breathing techniques on
      blood pressure and Quality of life in adults with stage 1 hypertension. In accessible
      literature limited data was found on the comparison of different breathing techniques. The
      current study will compare the effect of slow vs. diaphragmatic breathing exercises and will
      demonstrate which one is more effective.
    

Detailed description: 
      Literature reports that inspiratory muscle training is more effective in reducing Blood
      Pressure and voluntary diaphragmatic breathing at 10 or 6 breaths per minute for 10 min twice
      a day for 4 weeks is effective in producing positive outcomes in hypertensive patients.
    

Intervention name(s): Slow breathing exercise group; Diaphragmatic breathing exercise group
Intervention type(s): Other; Other
Intervention description(s): The patient will be first asked to close one nostril with a thumb and slowly breathe in completely through the other for 6 seconds. This nostril will be then closed and the patient will exhale through the other nostril over a period of 6 seconds. These steps complete one breathing cycle. An attempt will be made to keep the breathing rate is about 5-6 breaths per minute. Such alternate nostril breathing cycles will be repeated continuously for a period of about 15 minutes (3 sets of 5 minutes) in one sitting.; Patients would be instructed to Sit or lie down in a comfortable place and put their hands on their belly.
Relax the muscles in their neck and shoulders. Breathe in slowly through the nose, keeping their mouth closed. Feel the lungs fill with air and inflate like a balloon while their belly moves outward. Such breathing cycles will be repeated continuously for a period of about 15 (3 sets of 5 minutes) minutes in one sitting.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Stage 1 hypertension; Diaphragmatic breathing; Slow breathing; Quality of life
UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery
Condition: Urinary Tract Infections; Incontinence
MeSH terms: Urinary Tract Infections
Study type: Interventional

Summary: 
      The risk of urinary tract infection (UTI) following female incontinence surgery ranges
      between 6-48%. The literature has shown mixed results of the therapeutic efficacy of
      cranberry extract to prevent UTI in females, with some promising preliminary work in the
      prevention of UTI's following gynecologic surgery. The researchers will conduct a study of
      the effect of cranberry extracts on preventing urinary tract infections following mid
      urethral slings, which are the most common urinary incontinence procedures.
    

Detailed description: 
      The researchers are going to perform a randomized, double-blind, placebo controlled trial of
      cranberry extract capsules for the prevention of UTI following incontinence surgery. They
      will recruit patients from a single hospital in a 24 month duration. Eligible participants
      are women undergoing elective incontinence procedures that does not involve fistula repair or
      vaginal mesh excision. The therapeutic regimen will be Theracran One cranberry capsules
      containing 36mg of proanthocyanidins and placebo cranberry capsules and placebo capsules.
      Both will be supplied by Theralogix Nutritional Sciences.

      Following randomization into treatment or placebo therapy, the participants will be asked to
      start prophylaxis on day of surgery for a duration of six weeks. The researchers will collect
      urine specimen via catheter upon insertion in the operating room. At time of discharge, the
      researchers will provide all participants with capsules for six weeks of the assigned regimen
      until they are seen for their post-operative visit.

      Participants will be told to contact research staff immediately and collect a urine specimen
      should they experience urinary symptoms consistent with UTI. The researchers will administer
      a brief structured interview regarding type and duration of symptoms and refer for treatment
      when necessary. Urine will be cultured using standard microbiologic techniques for the
      presence of uropathogens at one clinical laboratory.

      Participants will be asked to complete a self-administered questionnaire at the two week
      post-operative clinic visit and again at six weeks. At study exit, the researchers will
      collect capsule bottles to ensure and assess compliance.
    

Intervention name(s): Cranberry extract capsules; Placebo capsule
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants in the treatment arm will receive cranberry extract capsules.; Participants in the placebo arm will receive placebo capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention