bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis
Condition: Diarrhea
MeSH terms: Gastroenteritis; Diarrhea
Intervention: oral rehydration solution Hipp ORS Apple 200; ESPGHAN ORS
Intervention description: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase); Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 147.0
Sex: All
Minimum age: 4 Months
Maximum age: 48 Months
Healthy volunteers: No
Keywords: diarrhea

Summary:

      It is generally recommended that oral rehydration should be used as first-line therapy to
      treat or prevent dehydration in children with acute gastroenteritis (AGE). Refusal to drink
      regular Oral Rehydration Solution (ORS) interfere with compliance with the recommended
      treatment.

      The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a
      new ORS (Hipp ORS 200 Apple) of improved palatability with regular ORS recommended by ESPGHAN
      in children with acute gastroenteritis (AGE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  children age 4 to 48 months

          -  diarrhoea defined as the passage of three or more loose or watery stools per day for
             >1 but <5 days

          -  mild (3%) or moderate dehydration (3-9%) according to the World Health Organization
             criteria (Table 1)

          -  informed consent signed by at least one parent / caregiver

        Exclusion Criteria:

          -  diarrhea for <1 or >5 days

          -  severe dehydration (>9%)

          -  recent history of diarrhea indicated either by parent/guardian or hospital case notes

          -  underlying chronic gastrointestinal disease (i.e., celiac disease, cow's milk protein
             intolerance)

          -  breastfeeding >50%

          -  under nutrition (weight/height ratio below the fifth percentile)

          -  systemic infections

          -  immune defects or immunosuppressive treatment
Effects of Oral Sildenafil on Mortality in Adults With PAH
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: sildenafil citrate; sildenafil citrate; sildenafil citrate
Intervention description: sildenafil citrate (PDE-5 inhibitor) 5 mg tablet TID until study treatment discontinued or end of study; sildenafil citrate (PDE-5 inhibitor) 20 mg tablet TID until study treatment discontinued or end of study; sildenafil citrate (PDE-5 inhibitor) 80 mg tablet TID until study treatment discontinued or end of study
Intervention MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 385.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: pulmonary arterial hypertension; pulmonary hypertension; PAH; sildenafil; revatio

Summary:

      This is a blinded study in adult patients with PAH evaluating the relative effects of
      sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three
      times per day [TID]). In addition, the relative effects on clinical worsening and 6-minute
      walking distance (6MWD) will be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects ≥ 18 <75 years of age with any of the following conditions:

          -  Idiopathic Primary Pulmonary Arterial Hypertension (IPAH)

          -  PAH secondary to connective tissue disease

          -  PAH with surgical repair (at least 5 years previously) of atrial septal defect
             (ASD),ventricular septal defect (VSD), patent ductus arteriosus (PDA) and
             aorto-pulmonary window

          -  PAH diagnosis confirmed by right heart catheterization performed within 12 months
             prior to randomization

          -  Functional Class II-IV; Baseline 6MWD ≥ 50 m.

        Exclusion Criteria:

          -  Significant (ie, >2+) valvular disease other than tricuspid regurgitation or pulmonary
             regurgitation

          -  History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular
             tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation

          -  History of pulmonary embolism; History of chronic lung disease / restrictive lung
             disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with
             impairment of lung function

          -  No prior long term treatment with PDE-5 inhibitors

          -  Treatment with bosentan OR riociguat within 3 months of randomization

          -  Current treatment with nitrates or nitric oxide
Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis
Condition: Tinea Pedis; Tinea Cruris
MeSH terms: Tinea; Tinea Pedis; Tinea cruris
Intervention: NAFT500 (pediatric); NAFT600 (pediatric); NAFT500 (adult); NAFT600 (adult)
Intervention description: Applied to both feet and groin area; Applied to both feet only; Applied to both feet and groin area; Applied to both feet
Intervention MeSH terms: Naftifine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Tinea Pedis; Tinea Cruris; Athlete foot; Jock itch

Summary:

      This study is being done to see how the body is affected when a study drug is applied to both
      feet if the subject has athlete's foot or to both feet and the groin area if the subject has
      both athlete's foot and jock itch. Safety of the drug and how well the drug works will also
      be measured.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have Tinea pedis on both feet and Tinea cruris infections for NAFT-500;
             both conditions must be characterized by clinical evidence of a Tinea infection.

          -  Subjects must have Tinea pedis on both feet for NAFT-600; the condition must be
             characterized by clinical evidence of a Tinea infection.

        Exclusion Criteria:

          -  A known hypersensitivity to study medications or their components

          -  Any severe condition of Tinea pedis (incapacitating)

          -  Any dermatological disease and or condition in the treatment or surrounding area that
             may prevent application of the study product such as foot psoriasis, corns and /or
             callus involving any web spaces, or atopic or contact dermatitis

          -  Positive pregnancy test

          -  Any history or current evidence (physical or laboratory) of anemia
Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Alendronate
Intervention MeSH terms: Alendronate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Female
Minimum age: 65 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      This is a pilot study evaluating the recruitment strategies for sites and patients, data
      collection instruments, follow-up procedures, administrative processes, and the proposed
      management strategy for the future large scale national trial.
    

Eligibility criteria:

        Inclusion Criteria:

        1.Females 65+

        2.3+ years of alendronate (Fosamax/Binosto) use

        3. Valid social security number

        Exclusion Criteria:

          1. History of any other metabolic bone condition, such as Paget Disease of Bone

          2. Currently receiving treatment for ongoing cancer, excluding non-melanoma skin cancer.

          3. Has significant underlying illness that would be expected to prevent completion of the
             study (e.g., life-threatening disease likely to limit survival to less than 3 years)?

          4. HIV positive

          5. Involved in a conflicting (investigational drug) clinical trial
Stress Testing and Cardiac Magnetic Resonance
Condition: Coronary Disease
MeSH terms: Coronary Disease; Coronary Artery Disease
Intervention: regadenoson
Intervention description: Subjects in open label group will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus) as contrast.
Intervention MeSH terms: Regadenoson
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Coronary Disease; Stress Testing; Lexiscan (regadenoson); Cardiac Magnetic Resonance Imaging

Summary:

      The purpose of this study is to better define the role of a comprehensive stress MRI (which
      includes myocardial perfusion imaging, optimized coronary imaging, and myocardial scar
      imaging) in medical practice and in patient health management. Information gathered from the
      healthy volunteers that participate in this study will be compared to information from the
      coronary artery disease patients in this study in order to help further our understanding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Suspected coronary artery disease

          -  Symptoms of possible coronary artery disease

        Exclusion Criteria:

          -  Acute ST-elevation myocardial infarction

          -  Second or third degree AV block

          -  Severe Renal Disease (Glomerular Filtration Rate (GFR) <30cc/min or hemodialysis)

          -  Contra-indications to MRI (i.e. Implantable Cardioverter Defibrillator (ICD),
             pacemaker, aneurysm clip, etc)

          -  Hemodynamic instability

          -  Inability to provide informed consent

          -  Severe claustrophobia

          -  Pregnancy

          -  Age <18 years
Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men.
Condition: Obesity
MeSH terms: Insulin Resistance; Hypersensitivity
Intervention: Tadalafil; Placebo
Intervention description: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.; Calcined magnesia capsules: one per day, at night, during 28 days.
Intervention MeSH terms: Tadalafil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: Male
Minimum age: 30 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Obesity; Tadalfil; Insulin secretion; Insulin sensitivity

Summary:

      Obesity is a chronic disease of multifactorial etiology that develops from the interaction of
      the influence of nutritive , metabolic , cellular and molecular psychological factors.

      Tadalafil is Is a drug inhibiting the enzyme phosphodiesterase-5 (PDE-5), responsible for
      inactivating the vasodilator nitric oxide. USING paragraph was mainly treat erectile
      dysfunction, and recently approved for the treatment of pulmonary hypertension , it is
      innovative because of its longer life means, provides efficacy after 36 hours and the highest
      selectivity.

      The aim of this study is to evaluate the effect of tadalafil on insulin sensitivity and
      insulin secretion in obese men.

      The investigators hypothesis is that the administration of tadalafil improve the insulin
      sensitivity and insulin secretion in obese men.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men

          -  Age: 30-50 years

          -  BMI: 30 to 39.9 kg/m²

          -  No Pharmacotherapy during the last 3 months

          -  Signature Consent under Information

        Exclusion Criteria:

          -  Cholesterol: ≥ 240 mg / dl

          -  Triglycerides: ≥ 400 mg / dl

          -  Fasting glucose: ≥ 126 mg / dl

          -  Diabetes mellitus.

          -  Hypertension

          -  Patients with renal, liver and / or thyroid disease

          -  Consumption of drugs with known effects on glucose or insulin metabolism.

          -  Use of cigar and / or drugs

          -  Hypersensitivity to tadalafil
Role of Propofol Postconditioning on Oxidative Stress and Cognitive Function
Condition: Cerebral Arterial Aneurysm
MeSH terms: Aneurysm
Intervention: propofol postconditioning; sevoflurane
Intervention description: administrated Target Controlled Infusion(TCI) of propofol (Cp 1.2ug/ml) and decreased sevoflurane with a Bispectral index (BIS) value of 40-60 to maintain anesthesia after clamp removal; 0.5%-2% sevoflurane with BIS 40-60
Intervention MeSH terms: Propofol; Sevoflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate differences between propofol postconditioning and
      sevoflurane anesthesia in the intracranial aneurysm surgery about antioxidant effect.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis intracranial aneurysm surgery ,

          -  American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ.

        Exclusion Criteria:

          -  severe hepatic and renal dysfunction

          -  coagulation disorder

          -  taking antioxidant perioperative period
Steroid Administration for Articular Fractures of the Elbow (SAFE Trial)
Condition: Elbow Fracture
MeSH terms: Fractures, Bone; Elbow Fractures; Intra-Articular Fractures
Intervention: Glucocorticoids; Saline
Intervention description: Patients will receive a single intraoperative dose of 10mg of intravenous dexamethasone intraoperatively. Following surgery, the participant will be provided with a six-day oral methylprednisolone taper course.; Patients will receive a single intraoperative dose of 10 mg of saline. Following surgery, the participant will be provided with a six-day placebo course.
Intervention MeSH terms: Dexamethasone; Methylprednisolone; Glucocorticoids
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The treating physician and patient will be blinded to the treatment assignment.
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glucocorticoid Administration

Summary:

      The primary purpose of this study is to determine if perioperative glucocorticoid
      administration (IV intra-operative followed by a post-operative oral taper course) improves
      post-operative range of motion in a patient population that has sustained an intra-articular
      elbow fracture(s) (radial head, proximal ulna, distal humerus, or combined) that required
      operative fixation.
    

Eligibility criteria:

        Inclusion Criteria

        • All adults ≥18 years old with an isolated, intra-articular traumatic elbow fracture to be
        treated at Vanderbilt University Medical Center with operative intervention and a
        standardized post-operative rehab protocol.

          -  Intra-articular elbow fracture defined as:

               -  Distal humerus

               -  Proximal ulna

               -  Radial head fracture

               -  Combination fracture of two or more of the above

          -  Radiographs present confirming intra-articular injury

        Exclusion Criteria

          -  Patients with bilateral elbow fractures

          -  Patients with an altered mental status

          -  Pregnant

          -  Allergy or contra-indication to glucocorticoid administration

          -  Type 1 or Type 2 diabetes

          -  Pre-injury limitation in elbow range or motion (patient reported)

          -  Unable to provide consent for themselves
Optimal Care of Complicated Appendicitis
Condition: Appendicitis; Perforated Appendicitis; Ruptured Appendicitis; Complicated Appendicitis
MeSH terms: Appendicitis
Intervention: Early Appendectomy; Interval Appendectomy; Antibiotics
Intervention description: Removal of the appendix within 24 hours of admission; Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery.; Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Intervention MeSH terms: Anti-Bacterial Agents; Metronidazole; Ciprofloxacin; Tazobactam; Piperacillin; Piperacillin, Tazobactam Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      When the appendix becomes infected and inflamed, it is called appendicitis. Sometimes, if the
      infection and inflammation get worse, the appendix can die or burst, leading to a larger
      infection or even pus pockets around the appendix. This is called complicated, or perforated,
      appendicitis. Three common treatments for complicated appendicitis are

        -  appendectomy (removal of the appendix) right away

        -  appendectomy several weeks after the diagnosis

        -  treating the appendicitis without performing an appendectomy

      This study seeks to determine which of these three approaches is most cost-effective in
      children with complicated appendicitis.
    

Eligibility criteria:

        Inclusion criteria

          1. At least 1 of the following CT or MRI findings:

               1. Peri-appendicular abscess

               2. Extruded appendicolith

               3. Visible hole in appendiceal wall

               4. Free peritoneal air

             OR

          2. CT or MRI read with phlegmon or diffuse/extensive inflammation/free fluid plus 1 of 3
             of the following (with CT) or 2 of 3 of the following (with MRI) *:

               1. White blood cell count (WBC) >15

               2. Peritonitis (involuntary right lower quadrant (RLQ) guarding, + Rovsing sign,
                  percussion tenderness, and/or rebound tenderness)

               3. Temperature > 38.0 C *>90% specificity for complicated appendicitis based on
                  unpublished institutional data

        Exclusion Criteria

          1. Immunocompromized state

          2. History of major abdominal operation

          3. Previous appendicitis

          4. Major comorbidities that preclude safe operation

          5. Inability to follow-up or appropriately consent

          6. Pregnant women

          7. Allergy to penicillin plus any one of the following:

               1. Hypersensitivity to ciprofloxacin and/or metronidazole

               2. Pregnant/lactating women

               3. Patients taking theophylline

               4. Patient taking tizanidine
Topical Antimicrobial Effectiveness Testing
Condition: Antimicrobial Effectiveness
Intervention: ChloraPrep One-Step; 70% isopropyl alcohol
Intervention description: 10.5 ml applicator preoperative skin preparation; 10.5 ml applicator
Phase: Phase 4
Study type: Interventional
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to measure the antimicrobial effectiveness of
      ChloraPrep one-Step.
    

Eligibility criteria:

        Inclusion Criteria:

          -  in good general health

          -  have skin within 6 inches of the test sites that is free of tattoos, dermatoses,
             abrasions, cuts, lesions or other skin disorders.

        Exclusion Criteria:

          -  topical or systemic antimicrobial exposure within 14 days prior to Screening Day
Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults
Condition: Pneumonia, Pneumococcal; Pneumococcal Infections; 13-valent Pneumococcal Vaccine
MeSH terms: Pneumonia; Pneumococcal Infections; Pneumonia, Pneumococcal
Intervention: VACCINE: placebo; VACCINE: 13-valent pneumococcal conjugate vaccine
Intervention description: 0.5 mL, single intra-muscular injection; 0.5 mL, single intra-muscular injection
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84496.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the efficacy of 13-valent pneumococcal conjugate
      vaccine in the prevention of the first episode of vaccine-type pneumococcal
      community-acquired pneumonia in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults aged 65 years or older on the day of vaccination and able to
             fulfill study requirements.

        Exclusion Criteria:

          -  Previous vaccination with any licensed or experimental pneumococcal vaccine

          -  Residence in a nursing home, long-term care facility, or similar facility

          -  Known hypersensitivity to vaccination

          -  Immune deficiency or suppression