bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study in healthy sexually active females is to evaluate the cycle control
      with norgestimate/ethinyl estradiol versus drospirenone/ethinyl estradiol.
    

Detailed description: 
      This is a randomized, open-label, active-controlled, multicenter study in healthy sexually
      active females to evaluate cycle control with norgestimate/ethinyl estradiol versus
      drospireneone/ethinyl estradiol. The Open-Label Treatment Phase will last for three 28-day
      cycles. Approximately 300 patients will be randomized in a 1:1 fashion according to a
      predetermined randomization schedule. Patients will be seen for a baseline visit (Visit 1) up
      to 35 days prior to dosing to obtain informed consent, have a physical examination including
      a breast exam, height and weight, vital signs, a Chlamydia test and a urine pregnancy test
      performed, and to give their medical history. Patients will be instructed to report bleeding
      data using an interactive voice response system (IVRS) based diary on a daily basis. Patients
      will be instructed to continue taking 1 pill each day for 3 cycles, record this information
      daily in the IVRS and to contact the study site if they have any questions or adverse events
      they would like to discuss. The final study visit (Visit 2) will occur on Day 8 after
      completing 3 cycles of study medication. Patients will be weighed, have vital signs
      performed, report any adverse events and or changes in concomitant medications, and complete
      the satisfaction questionnaire at the final visit. Safety will be assessed by physical
      examinations, adverse events, body weight and vital signs. Patients randomized to
      drospireneone/ethinyl estradiol and taking any medication that could increase serum potassium
      levels (as outlined in the Package Insert) will also have their potassium level checked
      during their first cycle of treatment (Days 15 to 28 of treatment). Three 28-day cycles of
      either norgestimate/ethinyl estradiol or drospirenone/ethinyl estradiol.
    

Intervention name(s): Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol
Intervention type(s): Drug
Intervention MeSH terms: Drospirenone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Norgestimate; Drospirenone and ethinyl estradiol combination; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contraception; bleeding; cycle control
Characterization of the Molecular Mechanisms Involved in Delayed-Type Hypersensitivity Reactions to House Dust Mite, Diphencyprone, Nickel, and Tuberculin Purified Protein Derivative in Healthy Volunteers
Condition: Delayed Type Hypersensitivity
MeSH terms: Hypersensitivity; Hypersensitivity, Delayed
Study type: Interventional

Summary: 
      This study will be conducted in 2 cohorts.

      In Cohort A, approximately 40 subjects will participate in a single-center, open-label,
      non-randomized, parallel-group trial to investigate the molecular mechanisms involved in
      delayed-type hypersensitivity (DTH) to various antigens and assess the most appropriate skin
      challenge antigen to study the effect of systemic treatments on T cells.

      Following evaluation of the results in Cohort A, approximately 20 healthy volunteers will be
      enrolled in Cohort B. This cohort will be a single-center, double-blind, randomized, two-arm,
      placebo-controlled study to evaluate the effect of corticosteroid treatment on the molecular
      and cellular phenotype of delayed hypersensitivity response to one if the antigens previously
      studied in Cohort A.
    


Intervention name(s): Prednisone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg (8 x 5mg tablets) for three consecutive days, then 30 mg (6 x 5mg tablets), 20 mg (4 x 5 mg tablets), 10 mg (2 x 5 mg tablets) and 5 mg (1 x 5 mg tablet) daily for two consecutive days for each dose level for a total of 11 days of treatment.; 8 tablets for 3 consecutive days; then 6 tablets, 4 tablets, 2 tablets, and 1 tablet daily for 2 consecutive days for each tablet count for a total of 11 days
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cohort A Open label: 4 groups of 10 subjects Cohort B Double-Blind: 1 group of 20 subjects
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Insulin Sensitizers Role in Control of PCOS Vicious Cycle.
Condition: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      PCOS is a common and complex disease affecting women of reproductive age. It is characterized
      by its complex pathological symptoms and mechanisms resulting in endocrine and metabolic
      dysfunction. PCOS is highly associated with various metabolic and endocrinal disorders.
      Metformin is mainly used for its glucose-lowering effects for treatment and prevention of
      type-2 diabetes mellitus (DM), gestational DM, and PCOS. Myo-inositol (MI) protects against
      MAFLD through reduction of hepatic accumulation of triglycerides.
    


Intervention name(s): Metformin Hydrochloride; MI/DCI combination in 40:1 ratio; Combination of Metformin hydrochloride and MI/DCI
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Met Group Received metformin hydrochloride 500 mg tab 3 times Daily; MI-group received MI/DCI combination in 40:1 ratio twice daily; MM Group Received both Met and MI Groups Treatment
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Between Propofol-remifentanil Total Intravenous Anesthesia and Desflurane-remifentanil Balanced Anesthesia With Regard to Post-anesthetic Functional Recovery Measured With QoR-40 in Vitrectomy
Condition: Vitrectomy Operation Under General Anesthesia
Study type: Interventional

Summary: 
      Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely
      used, and there are many clinical trials comparing these on various aspects of anesthesia.
      However, there have not been studies comparing the quality of recovery from the different
      methods of general anesthesia in vitrectomy. In this study, the investigators compare the
      functional recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40
      questionnaire in vitrectomy.
    


Intervention name(s): fresofol and remifentanil; desflurane and remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): Anesthesia is maintained with fresofol and remifentanil in TIVA group or with desflurane and remifentanil in Des group according to randomly allocated group.; Anesthesia is maintained with fresofol and remifentanil in TIVA group or with desflurane and remifentanil in Des group according to randomly allocated group.
Intervention MeSH terms: Remifentanil; Desflurane; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: propofol; desflurane; quality of recovery; vitrectomy
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness, tolerability, and safety of
      oxymorphone immediate release (IR) oral liquid as an analgesic for acute postoperative pain
      in pediatric subjects.

      This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer
      promotes opioids and no longer markets Opana® ER.
    


Intervention name(s): oxymorphone HCl
Intervention type(s): Drug
Intervention description(s): Comparison of different dosages of drug, 0.05mg/kg, 0.10mg/kg, 0.15mg/kg or 0.20mg/kg oral liquid oxymorphone
Other intervention name(s): Opana
Intervention MeSH terms: Oxymorphone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: surgical pain; acute pain; Acute Post Surgical Pain
Screening of Patients Admitted to a Local Hospital With Pocket-sized Ultrasound
Condition: Heart Disease; Dyspnea; Aortic Disease; Kidney Disease; Liver Disease
MeSH terms: Liver Diseases; Dyspnea; Kidney Diseases; Heart Diseases; Aortic Diseases
Study type: Observational

Summary: 
      Ultrasound (US) is widely used as a diagnostic tool in a hospital setting. In a medical
      department, diagnosis like heart failure or most kinds of heart diseases, hypervolemia,
      hypovolemia, pleural effusion, pericardial effusion, ascites, diseases in the gall
      bladder/bile tract, urine tract and venous thrombosis are common. US is the key diagnostic
      tool in these diagnosis, and on early diagnosis is crucial both on behalf of the patients
      well-being, and for hospital logistic reasons.

        1. The aim is to study the clinical use of pocket sized US as a screening diagnostic tool
           in an department of internal medicine.

           Method: All patients admitted (in certain preset periods) to Department of medicine will
           be screened with pocket sized US by expert user. Changes in diagnoses, as well as
           medications as a result of US screening will be the endpoints. US findings will be
           validated against standard echocardiography, or standard US/CT/MRI performed at the
           Radiological department.

        2. The aim is to study the clinical use of pocket sized US as a screening diagnostic tool
           in a department of cardiology.

           Method: All patients admitted (in certain preset periods) to Department of cardiology
           will be screened with pocket sized US for heart disease, pericardial and pleural
           effusion. Examinations by expert users. Specific findings could be myocardial
           dysfunction as heart failure, cardiomyopathies, regional dysfunction due to ischemia,
           valvular dysfunction, atrial enlargement, and pleural/pericardial effusion. Changes in
           diagnoses, as well as medications as a result of US screening will be the endpoints. US
           findings will be validated against standard echocardiography in all.

        3. As in 1), but examination by non-expert users compared to expert users.
    


Intervention name(s): Ultrasound examination
Intervention type(s): Other
Intervention description(s): Screening with bedside ultrasound examination
Other intervention name(s): GE Vingmed VScan
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients admitted to Dep. of Medicine at Levanger Hospital Randomized study. Both sexes.
        Age above 16 years
      
Biospecimen description: 
      Serum blood samples including; hematology, electrolytes, creatinine, liver enzymes and
      cholestasis parametres, brain natriuretic peptides etc.
    
Keywords: Echocardiography; Heart failure; Kidney; Lung; Aorta
Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56
Condition: Myocardial Infarction; Percutaneous Coronary Intervention
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine whether higher as compared with lower maintenance doses of clopidogrel can
      adequately improve the degree of platelet inhibition in carriers of a reduced-function
      CYP2C19 allele.
    

Detailed description: 
      Clopidogrel blocks the P2Y12 ADP receptor on platelets and has been shown to reduce
      cardiovascular events in acute coronary syndrome (ACS) patients.However, inter-patient
      variability in the pharmacodynamic response to clopidogrel is well recognized, and patients
      with lesser degrees of platelet inhibition in response to clopidogrel have been shown to be
      at increased risk of cardiovascular events.

      One potential source of this variability is the metabolism of clopidogrel, which is a
      pro-drug requiring biotransformation to become an active antiplatelet compound. Cytochrome
      P-450 (CYP) enzymes play a role in the metabolism, and carriers of reduced-function genetic
      variants in CYP2C19 (~30% of the population) have lower active clopidogrel metabolite levels,
      diminished platelet inhibition, and higher rates of adverse cardiovascular events as compared
      with non-carriers in the setting of treatment with standard maintenance doses of clopidogrel.

      Aim: To determine whether higher as compared with lower maintenance doses of clopidogrel can
      adequately improve the degree of platelet inhibition in carriers of a reduced-function
      CYP2C19 allele.

      Hypotheses: The primary hypothesis is that subjects who carry a reduced-function CYP2C19
      allele will have improvement in platelet inhibition with higher maintenance doses of
      clopidogrel.The secondary hypothesis is that higher maintenance doses of clopidogrel in
      carriers of a reduced-function CYP2C19 allele will result in similar platelet inhibition as
      compared to a standard maintenance dose of clopidogrel in non-carriers.
    

Intervention name(s): Clopidogrel; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Clopidogrel 75 mg daily, 150 mg daily, 225 mg daily, and 300 mg daily based on genotype; Clopidogrel 75 mg daily, 150 mg daily
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myocardial infarction; Percutaneous coronary intervention; Clopidogrel; Genetics; Platelet Function
Dapagliflozin in Physical Exercise in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      Inhibitors of sodium-dependent glucose-transporter 2 (SGLT-2 inhibitors, including
      dapagliflozin) inhibit glucose reabsorption in renal tubular cells, hereby increasing
      glycosuria in the hyperglycemic state. Its mechanisms of action are independent of insulin,
      which makes SGLT-2 inhibitors a potential adjunct to insulin in type 1 diabetes mellitus
      (T1DM).

      However, a higher risk for diabetic ketoacidosis (DKA) was reported in patients with T1DM
      taking SGLT-2 inhibitors. DKA depends on an accumulation of ketone bodies in the blood
      stream, which equals an accumulation of acids that lead to acidosis. The underlying
      mechanisms of this observation are unknown. Ketone body production depends on the molar ratio
      of glucagon to insulin, with insulin suppressing but glucagon stimulating ketone body
      production. This translates into higher production during relative insulin deficiency,
      carbohydrate deficiency, and prolonged fasting, which occurs during sickness but also
      physical exercise. Physical exercise is a recommended cornerstone in the treatment of T1DM
      and current treatment guidelines recommend both, reductions of insulin doses and ingestion of
      additional carbohydrates to avoid hypoglycemic events. These adaptions might increase
      relative insulin deficiency, hyperglycemia and glycaemic variability, which might in turn
      promote ketone body production. The addition of SGLT-2 inhibitors further may promote
      ketogenesis even though there are reports of SGLT-2 inhibitors increase
      Glucagon-like-peptide-1 (GLP-1) in patients with T1DM. GLP-1 is a suppressor of glucagon
      secretion. In summary, knowledge about the effects of SGLT-2 inhibition on ketone body
      production is scarce, especially during exercise in patients with T1DM.

      The study seeks to illustrate the effect of SGLT-2 inhibition on glycemic variability and
      ketone body production during and after recreational exercise in patients with T1DM. The
      results of study 2 will provide the basis for future studies investigating the underlying
      mechanisms of potentially modified ketone body production during and after exercise under
      SGLT-2 inhibition.
    


Intervention name(s): Forxiga 10mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dapagliflozin 10mg per 24 hours, oral, for 7 consecutive days; Placebo 1 tablet per 24 hours, oral, for 7 consecutive days
Other intervention name(s): Dapagliflozin
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, placebo-controlled, open-label, crossover
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is designed to compare the effects of twice-daily (before lunch and before dinner)
      exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before
      dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2
      diabetes.
    


Intervention name(s): exenatide; exenatide
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner); subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner)
Other intervention name(s): Byetta; Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; exenatide; Lilly; Amylin
The SMART A Exercise Study :''The SMART Study''
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Despite the promising data emanating from trials investigating the effectiveness of advanced
      hybrid closed loop (AHCL) insulin delivery systems in managing glycaemia in those with type 1
      diabetes (T1D), we currently know little about their efficacy in optimising glycaemia when
      physical activity is factored into the equation. With the introduction of new AHCL systems
      that have novel technological features, we are left with important questions of how to
      optimise their use around physical exercise to not only minimise dysglycaemia, but also
      encourage individuals with T1D to lead a physically active lifestyle for the associated wider
      health benefits.

      This will be a three-period, randomised, cross-over study with a single-hormone (insulin)
      AHCL system that compares the efficacy of three insulin management strategies: (i)
      unannounced exercise and a full dose of meal-time insulin 90-minutes prior to commencement,
      (ii) a 25% reduced dose of meal-time insulin with exercise announcement 90-minutes prior to
      commencement and (iii) a 25% dose reduction in meal-time insulin with exercise announcement
      45-minutes prior to commencement, in optimising TIR around dynamic physical exercise in
      adults with T1D.
    

Detailed description: 
      Following successful completion of a screening visit, participants will attend the laboratory
      to complete 3 experimental visits during which they will undertake a 45-minute bout of
      moderate intensity continuous exercise on a bicycle ergometer at ~60% VȮ2max. Prior to
      commencing exercise, participants will consume a standardised low-glycaemic index,
      carbohydrate-based meal (equating to 0.75g.CHO.kg.bm-1) with, or without, a 25% reduction in
      their meal-time insulin dose as well as with, or without exercise announcement (according to
      the randomisation). Exercise announcement will increase the individualised target glucose
      levels to 8.3 mmol.L-1. Venous blood glucose sampling will be taken in 15-minute intervals
      leading into and after exercise with 5-minute intervals performed during exercise. Samples
      will be used to retrospectively cross-compare trial day glycaemic responses between visits.
      Each participant will undertake 1 screening and 3 experimental visits equating to a total of
      80 study visits
    

Intervention name(s): Pump settings
Intervention type(s): Other
Intervention description(s): Alteration in the pump setting prior to exercise commencement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Laser Removal of Age (Sun) Spots on Hands
Condition: Solar Lentigines
MeSH terms: Lentigo
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether picosecond laser is effective in the
      treatment of age (sun) spots.
    

Detailed description: 
      The purpose of this study is to evaluate the safety and efficacy of Cutera Picosecond
      Q-Switched Nd:YAG 1064 and/or 532 nm laser in the treatment of benign pigmented lesions on
      the hands.
    

Intervention name(s): Picosecond QS Nd:YAG Laser
Intervention type(s): Device
Intervention description(s): Up to 2 laser treatments delivered 6 weeks apart
Other intervention name(s): Cutera
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sun; Age; Spot
Ribose and Sport Performance
Condition: Sports
Study type: Interventional

Summary: 
      Investigate the acute effect of ribose supplementation on performance and recovery in
      athletes.
    


Intervention name(s): Ribose; Placebo
Intervention type(s): Other; Other
Intervention description(s): After each of the 3km time trial (3 in total), participants will be asked to drink the experimental product (or placebo) incorporated in a sports drink.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Peak VO2 consumption; 3km time trial; fatigue perception; lactate; time to complete
Haemoglobin Measurement for Babies
Condition: Hemoglobins; Infant; Non-invasive
Study type: Interventional

Summary: 
      In this prospective study different methods of haemoglobin measurement in term and preterm
      neonates are compared with the gold standard. Non-invasive haemoglobin measurement with the
      Radical-7® (SpHb, Masimo®), point-of-care haemoglobin-measurement (HcHb, HemoCue@,
      Radiometer), blood-gas-analysis (BGAHb,ABL800®, Radiometer) are compared with haemoglobin
      measurement by an automated hematology analyzer (labHb, Siemens Advia®).
    

Detailed description: 
      Neonates admitted to neonatal intensive care unit or to a normal neonatal ward are enrolled
      in the study, if parents have given their written informed consent. Non-invasive SpHb
      measurements are recorded prior to routine venous sampling. Routine venous sampling includes
      labHb and BGAHb. Additionally HcHb is taken from the routine venous sampling (HcHbart/ven)
      and from an additionally capillary puncture of earlobe or heel (HcHbcap). Every neonate can
      participate in two measurements.
    

Intervention name(s): hemoglobin measurement
Intervention type(s): Other
Intervention MeSH terms: Chrysarobin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic