bioihbjkbjnl/mcl2 huggingface dataset:
Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia
Condition: Gestational Diabetes Mellitus; Pregestational Diabetes Mellitus; Mild Gestational Hyperglycemia
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Hyperglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Pregnancies complicated by diabetes and mild gestational hyperglycemia are associated with
      increased perinatal and maternal complications. The most serious maternal complication is the
      risk of developing type 2 diabetes after 10-12 years of the delivery. Perinatal complications
      include fetal macrosomia with consequent increased risk of obstetrical trauma and
      hypoxia/asphyxia, high rates of cesarean section, respiratory distress syndrome, and
      metabolic disorders at birth. Regardless of the diagnosis of diabetes and mild gestational
      hyperglycemia, the perinatal outcome is directly related to maternal metabolic control. For
      the tight control of blood glucose, pregnant women are treated as home care (outpatient) or
      hospital care. Objective: To evaluate the cost-effectiveness and safety of home versus
      hospital care of gestational diabetes and mild gestational hyperglycemia.
    


Intervention name(s): Home care; Hospital care
Intervention type(s): Other; Other
Intervention description(s): Home care, sometimes called "ambulatory care" or "outpatient", was defined as the blood-glucose self-monitored by the pregnant women at home. This project will provide glucometers to all those who are randomized to home care. The women will receive training for glucose control in pre-defined days, with the glucometer to obtain the mean glucose. According to blood-glucose levels in glycemic profile, insulin dose will be maintained or altered both in gestational diabetes as in mild gestational hyperglycemia .; Hospital care, sometimes called "acute care", was defined as control of maternal diabetes made at hospitals by admission to hospital. The blood-glucose and metabolic control are done in gestational diabetes and mild gestational hyperglycemia treated conventionally.
The hospitalized patients will have their glycemic control done in the hospital. . According to blood-glucose levels in glycemic profile , insulin dose will be maintained or altered both in gestational diabetes as in mild gestational hyperglycemia.
All the women of the study will be accompanied by a team of obstetricians specializing in high-risk pregnancies; residents; dietitians; nurses and neonatologists.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Obesity With Vitamin D (40.000 IE Per Week for 1 Year)
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate if supplementation with vitamin D in doses of
      20.000IU per week and 40.000 IU per week will result in weight loss in obese subjects as
      compared to placebo during 1 year.
    

Detailed description: 
      We will include 450 obese subjects that will be devided in 3 groups: 40.000IU cholecalciferol
      per week, 20.000 IU cholecalciferol per week, and placebo. All subjects will be given 500 mg
      calcium per day. There will be visits every tird month. In addition to weight reduction, we
      will also evaluate the calcium metabolism (blood test and urin samples), insulin sensitivity,
      muscle strenght, blood pressure and depression.
    

Intervention name(s): Cholecalciferol
Intervention type(s): Drug
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effects of Continuous Combined Hormone Replacement Therapy and Clodronate on Bone Mineral Density (BMD) in Osteoporotic Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      Recent studies suggest that the combination of two inhibitors of bone resorption may induce a
      greater increase in bone mineral density (BMD) than either agent alone.

      In this 5-year partly randomized study the investigators examined the effects of hormone
      therapy (HT) with or without bisphosphonate on BMD on osteoporotic women.

      In the Kuopio Osteoporosis Study (OSTPRE) a population based sample of 3200 women were
      selected for BMD measurement by Lunar DPX in 1995-1997. In all 167 women aged 61±2.7 years
      (11±4.9 years postmenopausal), and the T-score < -2.5 SD at either the lumbar spine or
      femoral neck were recruited for this sub-study.

      They received daily estradiol hemihydrate (E2) 2mg + norethisterone acetate (NETA) 1mg
      (Kliogest®, Novo Nordisk, Denmark) and were randomized to get additional Boneplac, which
      consisted of either 800mg clodronate (Bonefos®, Leiras Ltd, Finland) (n=55, KB-group) or
      placebo (n=55, K-group). In case of contraindications or refusal from HT, the women were
      offered clodronate 800 mg/day (n=57, B-group) to be taken to empty stomach with a glass of
      water 30 minutes to two hours before breakfast.

      BMD was measured at time intervals 0, 1, 3 and 5-years. All repeated BMD values were
      interviewed by one investigator and primarily the vertebrae L2-L4 were followed. In case of
      spinal deformities during the study (38.3%) other lumbar levels were followed. The baseline
      BMD values (lumbar spine BMD 0.839±0.072 g/cm², femoral neck BMD 0.759±0.094g/cm²) were
      similar between the groups.
    


Intervention name(s): Klodronate and Kliogest; Placebo+ Kliogest; Bonefos
Intervention type(s): Drug; Procedure; Drug
Intervention MeSH terms: Clodronic Acid; Trisequens; Norethindrone; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: osteoporosis; Bone mineral density; clodronate; HRT; postmenopausal
Role of Laparoscopy in Unexplained Infertility
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      In this randomized controlled trial the investigators were looking for the best policy for
      management of women with unexplained infertility after normal hysterosalpingogram (HSG). The
      investigators test the hypothesis that postponing or even bypassing laparoscopy does not
      affect the outcome of management of women with apparently unexplained infertility.
    


Intervention name(s): laparoscopy; ovarian stimulation
Intervention type(s): Procedure; Other
Intervention description(s): subjected to laparoscopy; ovarian stimulation and timed intercourse for 3 cycles followed by ovarian stimulation and intrauterine insemination for another 3 cycles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: laparoscopy; unexplained infertility
Budesonide for Emergency Treatment of Acute Wheezing in Children
Condition: Asthma; Acute Asthma
MeSH terms: Asthma; Emergencies; Respiratory Sounds
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if adding nebulized budesonide to the systemic
      steroid for treatment of acute wheezing has any additive benefit in the emergency room.
    

Detailed description: 
      Context: Inhaled steroids reduced admission rates in patients with acute asthma, but it is
      unclear if there is a benefit of inhaled corticosteroids when used in addition to systemic
      corticosteroids. There is insufficient evidence that inhaled corticosteroids result in
      clinically important changes in pulmonary function or clinical scores when used in acute
      asthma. Similarly, it was mentioned in the Cochrane Database of Systematic Reviews that
      further research is needed to clarify if there is a benefit of inhaled corticosteroids when
      used in addition to systemic steroids.

      Objective: To determine if adding nebulized budesonide to the systemic steroid for treatment
      of acute wheezing in the emergency room has any benefit on, symptom score, hospitalization
      rate and time to discharge from emergency room.

      Study Design/Setting/Participants: A double-blind, randomized, controlled trial of nebulized
      budesonide versus placebo for children 6 months to 6 years of age who have admitted to the
      emergency room for acute wheezing.

      Intervention: Participants will receive standard therapy including SCS, albuterol, and
      ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or
      saline.

      Study Measures: Differences in asthma scores, vital signs, and the need for hospitalization
      will be compared between treatment groups.
    

Intervention name(s): 0.5 mg/ml budesonide nebules; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times; Children will receive 2 ml of saline every 20 minutes for 3 times
Other intervention name(s): Budesonide 0.5 mg/ml nebules; 0.9% Saline solution
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Wheezing; Acute asthma; Children; Budesonide; Emergency room
Effect of 24 h Severe Energy Restriction on Appetite Regulation and Ad-libitum Energy Intake
Condition: Deficiency; Calorie
Study type: Interventional

Summary: 
      Long term maintenance of weight loss is generally poor, which is at least partly due to
      increased feelings of hunger associated with restricting what can be eaten. Intermittent
      severe energy restriction is a novel dietary strategy that requires individuals to consume a
      very-low energy diet for 1-4 days per week, allowing normal feeding patterns to be adopted on
      the other days in the week. However, the effect of a consuming a very-low energy diet on
      appetite regulation, which might represent a key marker of long-term adherence to dieting,
      has not been determined. This study aimed to assess the effects of severely restricting
      energy intake for 24 h on markers of appetite regulation, energy balance and metabolism
      compared to an adequate energy trial.
    


Intervention name(s): Energy intake
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study of Flavocoxid (Limbrel) Versus Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of the study is to compare the efficacy and safety of flavocoxid (Limbrel) with
      Naproxen and placebo in OA of the knee.
    

Detailed description: 
      To compare the efficacy, safety, quality of life and economic impact of flavocoxid vs
      naproxen.
    

Intervention name(s): Flavocoxid 500 mg; Naproxen; Placebo; flavocoxid 250 mg
Intervention type(s): Dietary Supplement; Drug; Other; Other
Intervention description(s): flavonoid mixture; non-steroidal anti-inflammatory drug; Placebo; Medical food product
Other intervention name(s): Limbrel 500 mg; naprosyn; Limbrel 250 mg
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Exercise Activity-Based Bolus Decisions in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of the study is to demonstrate safety and feasibility of a decision support
      system aimed at improving activity-related insulin boluses in Type 1 Diabetes.
    

Detailed description: 
      Subjects with Type 1 diabetes often need to adjust insulin boluses for activity since
      activity may increase the chance of hypoglycemia. The aims of this study is to make better
      bolus decisions by integrating knowledge about daily physical activity (PA) into bolus
      decisions. It is expected to decrease risk of hypoglycemia related to previous PA and provide
      better glucose control. The idea is to first obtain a carbohydrate ratio that is optimized
      around the everyday activity level of the patient and then adjust boluses when the activity
      for the day is different (above or below) than their regular activity level.
    

Intervention name(s): Activity on Board; Usual Diabetes Care
Intervention type(s): Other; Other
Intervention description(s): During the collection phase, the study team will collect information on glucose values, activity measures and insulin settings. This information will be used to determine the meal and correction boluses during the study admission. Subjects will wear a continuous glucose monitor during the data collection phase and study admission.; Subjects will perform their usual diabetes care including basal rate, meal and correction boluses during the study admission. Subjects will wear a continuous glucose monitor during the study admission.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Type 1 Diabetes Mellitus; Insulin pump; Continuous Glucose Monitor (CGM); Exercise; Activity on Board; Decision Support System
Rivastigmine Bioequivalence Trial With Multiple Application of Transdermal Patches (9.5mg/24h)
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The present clinical trial will be conducted in order to compare the bioavailability of
      rivastigmine and to assess bioequivalence at steady-state of the Test product RID-TDS 9.5
      mg/24 h (Luye Pharma AG, Germany) and the marketed Reference product Exelon® 9.5 mg/24 h
      transdermales Pflaster (Novartis Pharma GmbH, Germany) after multiple patch application. Each
      of both treatments will last for 11 days with a washout period of 14 days between the
      treatments.
    


Intervention name(s): RID-TDS 9.5 mg/24 h; Exelon® 9.5 mg/24 h
Intervention type(s): Drug; Drug
Intervention description(s): 3 consecutive applications of 1 patch (1st patch for 4 days, 2nd patch for 3 days, 3rd patch for 4 days) covering an 11-day period; 11 consecutive applications of 1 patch (each patch will be applied for 1 day) covering an 11-day period
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy of Combining Pasireotide With Aspiration Sclerotherapy to Improve Volume Reduction of Hepatic Cysts
Condition: Symptomatic Dominant Liver Cyst
MeSH terms: Cysts
Study type: Interventional
Phase: Phase 3

Summary: 
      Liver cysts are fluid filled cavities located in the liver. They are present in 2-11% of the
      general population, typically not causing any symptoms or complications. However, in a small
      subset of patients complaints of pain, abdominal fullness and distension, dyspnea and nausea
      occur.

      Currently, aspiration and sclerotherapy is a treatment of choice in symptomatic patients with
      a large dominant liver cyst. However, studies reported early fluid reaccumulation and
      relative high recurrence rates of cyst growth after aspiration sclerotherapy ultimately
      leading to re-interventions. In this respect, somatostatin analogues are promising agents
      known for its volume reducing effect in patients with polycystic liver disease.

      In this study the investigators want to evaluate the effect of combining aspiration
      sclerotherapy with the multi-receptor binding, long-acting somatostatin analogue Pasireotide.

      The investigators hypothesize that administrating pasireotide before and after aspiration
      sclerotherapy could prevent early fluid reaccumulation and thereby result in a greater
      reduction of cyst diameter. Moreover, the investigators expect a lower rate of cyst
      recurrence and subsequently lower need for re-interventions.
    


Intervention name(s): Pasireotide LAR 60 mg; Aspiration sclerotherapy; Placebo
Intervention type(s): Drug; Procedure; Drug
Intervention description(s): Pasireotide long acting release, intramuscular injection; Percutaneous drainage of the hepatic cyst with subsequent ethanol instillation; Saline solution, injected as placebo
Other intervention name(s): Pasireotide long acting release, intramuscular injection; Drainage with subsequent ethanol instillation; Saline solution
Intervention MeSH terms: Ethanol; Pasireotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Liver cyst; Hepatic cyst; Symptomatic; Aspiration sclerotherapy
Zinc Dosing Trial - Does Dose Reduction Reduce Side Effects But Retain Efficacy in Diarrhoea Management
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      Diarrhoea continues to be a major cause of child deaths. Current treatment of acute watery
      diarrhoea includes oral rehydration solution (ORS), zinc and continued feeding. The use of
      zinc is based on a number of studies that showed that zinc reduces the duration and severity
      of diarrhoea. The recommended dose of zinc in 6-59 month old children is 20mg/day for 10-14
      days. This dose is associated with an increased risk of vomiting. No dosing studies are
      available to determine the optimal dose of zinc, which while maintaining the benefits also
      has a low risk of vomiting.

      The investigators will conduct a double-blind randomized controlled trial of three doses of
      zinc (20mg/day, 10mg/day and 5mg/day) in two settings - one in Sub-Saharan Africa and the
      other in South Asia. The study population will be 4500 children with diarrhoea of less than
      72 hours duration who are aged 6-59 months. They will be recruited from outpatient health
      facilities. All enrolled children will receive ORS and continued feeding as recommended by
      the World Health Organization. Those allocated to the standard zinc dose will receive an oral
      dispersible tablet with 20mg zinc daily for 14 days. Those allocated to lower dose zinc will
      receive identical tablets with either 10mg or 5mg zinc daily for 14 days. Enrolled children
      will be followed by until recovery from diarrhoea or 15 days after enrolment, whichever is
      later. In addition, study children will be assessed again at thirty (30), forty-five (45),
      and sixty (60) days to estimate impact on post illness outcomes. Primary outcomes will be
      mean duration of diarrhoea, proportion of episodes that last longer than 5 days, mean number
      of stools and proportion of children with vomiting.
    


Intervention name(s): Zinc tablets, 20 mg per day; Zinc tablets, 10 mg per day; Zinc tablets, 5 mg per day
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will receive rehydration, dietary counseling, and 1 tablet per day for 14 days of zinc-tablets, each of which contains 20 mg of zinc; Participants will receive rehydration, dietary counseling, and 1 tablet per day for 14 days of zinc-tablets, each of which contains 10 mg of zinc; Participants will receive rehydration, dietary counseling, and 1 tablet per day for 14 days of zinc-tablets, each of which contains 5 mg of zinc
Intervention MeSH terms: Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Performance and Accuracy of an AI Enhanced Smart Watch Single Lead ECG
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to show the artificial intelligence enhanced single-lead ECG
      Apple Watch has similar, robust performance comparable to an AI enhanced 12 lead ECG and AI
      enhanced single lead (LI) of a 12 lead ECG.
    

Detailed description: 
      1. Ambulatory patients undergoing ECG recording in the Mayo Clinic outpatient ECG lab will
           be asked to consent for this study.

        2. Those who consent for the study will be asked to record a ECG using a single-lead
           watch-based (Apple Watch series 5) recording at a visit for a clinically scheduled 12
           lead ECG recording.

        3. This watch-based ECG data will be recorded and analyzed in comparison to the
           near-simultaneously recorded outpatient 12 Lead ECG
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ambulatory patients who are undergoing a clinically ordered electrocardiogram in the Mayo
        Clinic outpatient ECG lab.
      
Keywords: electrocardiogram; wearable; artificial intellegence; Apple Watch
Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat Glabellar Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar
      frown lines.
    


Intervention name(s): Botulinum Toxin Type A; Active Comparator botulinum toxin; Placebo Comparator
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular injection (IM); IM injection; IM injection
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics and Pharmacodynamics Assessment of Drug Eritromax Compared to Eprex in Healthy Subjects.
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The epoetin is a glycoprotein and endogenous hormone, which is primarily synthesized by
      specific epithelial cells lining the kidney peritubular capillaries, and regulates continuous
      formation of red blood cells. This is a pharmacokinetics and pharmacodynamics study, in which
      each subject will receive the investigational product in different periods, as randomisation
      (Teste or Comparator). The evaluation of the profile included serum dosage of medications and
      reticulocyte count in peripheral blood.
    

Detailed description: 
      This a prospective randomized and crossover study for evaluation of pharmacokinetics and
      pharmacodynamics of two epoetins formulations. The subjects will receive in each confinement
      period 4000 IU one of the investigational product subcutaneously, according to randomisation,
      separated by a washout period of 4 weeks. The evaluation of the profile between products
      included serum dosage of medications and reticulocyte count in peripheral blood. Safety
      evaluation data will include report od all adverse events (including type, frequency,
      intensity, seriousness, severity and action taken related to the investigational product
      study).
    

Intervention name(s): Eritromax; Eprex
Intervention type(s): Drug; Drug
Intervention description(s): The subjects will receive a single dose of 4000 IU epoetin alfa in each period, according to randomisation.; The subjects will receive a single dose of 4000 IU epoetin alfa in each period, according to randomisation.
Other intervention name(s): epoetin alfa; epoetin alfa
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Erythropoeitin; Chronic kidney disease; Anaemia