bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: Teduglutide
Intervention description: Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.
Intervention MeSH terms: Teduglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this clinical study is to evaluate the long-term safety and tolerability of
      teduglutide treatment in Japanese pediatric participants with short bowel syndrome (SBS) who
      completed Study SHP633-302 (NCT02980666).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent by a parent or guardian prior to any study-related procedures.

          -  When applicable, informed assent (as deemed appropriate by the Institutional Review
             Board [IRB]) by the participant prior to any study-related procedures.

          -  Participant completed Study SHP633-302 (NCT02980666).

          -  Participant (and/or parent/guardian) understands and is willing and able to fully
             adhere to study requirements as defined in this protocol.

        Exclusion Criteria:

        There are no exclusion criteria for this study.
Micronutrient Sprinkles in a Daycare Center
Condition: Diarrhea; Respiratory Infection
MeSH terms: Infections; Respiratory Tract Infections; Diarrhea
Intervention: Micronutrient Sprinkles with zinc; Micronutrient sprinkles without zinc
Intervention description: Daily dose of 1 packet of sprinkles; I packet of micronutrient sprinkles without zinc
Intervention MeSH terms: Zinc; Trace Elements; Micronutrients
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 143.0
Sex: All
Minimum age: 6 Months
Maximum age: 4 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diarrhea; Pneumonia; Upper respiratory infections; Acute gastroenteritis

Summary:

      Diarrheal diseases are a major cause of morbidity and mortality globally in children less
      than 5 years of age. Prolonged diarrhea, recurrent infections and growth failure in
      developing countries are usually a consequence of micronutrient deficiencies including zinc.
      The primary aims of the proposed study are to evaluate the effect of the use of multiple
      micronutrient sprinkles including zinc on compliance of supplement use and the incidence of
      recurrent diarrheal and respiratory illnesses. The proposed study will be conducted at the
      Fima Lifshitz Metabolic Research Center, Department of Pediatrics, Universidade Federal Da
      Bahia, Salvador-Bahia, Brazil over a period of 18 months. This is a double-blind
      placebo-controlled trial involving the use of 2 types of micronutrient sprinkles in a group
      of 120 children who attend a day care center in Salvador, Bahia. They will be randomized into
      2 groups of 60 children each. The intervention group will receive sprinkles containing zinc
      while the control group will receive micronutrient sprinkles without zinc. The primary
      outcome variables of interest are zinc status, stool zinc losses and diarrhea duration. Both
      groups of infants will be monitored at monthly intervals for an initial duration of 180 days
      for zinc status, diarrhea episodes, respiratory illness and growth. This study will allow for
      the establishment of a cohort of children who will be monitored in a micronutrient
      supplementation trial using sprinkles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy children attending day care

        Exclusion Criteria:

          -  Chronic medical problems including sickle cell disease, congenital heart disease
Propranolol Rescue of Prolonged Labor
Condition: Pregnancy, Prolonged
MeSH terms: Pregnancy, Prolonged
Intervention: Propranolol Hydrochloride; Saline
Intervention description: 2mg/mL vials; 0.9% saline in vials matching the vials of the active drug
Intervention MeSH terms: Propranolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 164.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Propranolol; Cesarean

Summary:

      A double-blind placebo controlled randomized trial comparing cesarean delivery rates in women
      given IV propranolol versus placebo for treatment of prolonged labor.
    

Eligibility criteria:

        Inclusion Criteria:

        English-speaking

        >= 36 weeks gestation

        Singleton pregnancy

        Vertex presentation

        No contraindication to a vaginal delivery

        Meets at least one study criteria for prolonged labor:

          1. cervical dilation <6 cm after ≥8 hours with ruptured membranes and receiving oxytocin
             OR

          2. cervical dilation >=6 cm and <1 cm dilation change over ≥2 hours with ruptured
             membranes and receiving oxytocin

        Exclusion Criteria:

        Severe preeclampsia: as patients will be receiving magnesium and possibly labetalol for
        hypertension control

        Receiving other beta blocker

        Maternal heart rate < 70 beats per minute, systolic blood pressure <90 mmHg, or diastolic
        blood pressure <50 mmHg on two sets of vital signs in the 1 hour prior to study drug
        administration: given that bradycardia and hypotension are possible side effects of
        propranolol

        History of any form of asthma: as this is a contraindication to beta blocker use

        Diabetes requiring insulin in labor: given the potential risk of neonatal hypoglycemia in
        the neonate

        Any cardiac condition for which β blockade is contraindicated (cardiogenic shock, sinus
        bradycardia, and greater than first degree heart block)

        Known hypersensitivity to propranolol

        Intrauterine fetal demise since different labor protocols are used in these women

        Major fetal congenital anomaly since rate of cesarean may be inherently different in these
        women, unrelated to labor
Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Oliceridine; Placebo; Morphine
Intervention MeSH terms: Morphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 418.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine
      administered as needed (PRN) compared with placebo in patients with moderate to severe acute
      postoperative pain after bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and
             internal fixation) with no additional collateral procedures.

          -  Experiences a pain intensity rating of moderate to severe acute pain.

          -  Able to provide written informed consent before any study procedure.

        Exclusion Criteria:

          -  ASA Physical Status Classification System classification of P3 or worse.

          -  Has surgical or post-surgical complications.

          -  Has clinically significant medical conditions or history of such conditions that may
             interfere with the interpretation of efficacy, safety, or tolerability data obtained
             in the trial, or may interfere with the absorption, distribution, metabolism, or
             excretion of drugs.

          -  Has previously participated in another TRV130 clinical study.
Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol; Formoterol; Placebo to indacaterol; Placebo to formoterol
Intervention description: Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).; Formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).; Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).; Placebo to formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1732.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: chronic obstructive pulmonary disease; COPD; indacaterol; long-acting β2 agonist

Summary:

      This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses
      of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with
      chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either
      indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily,
      or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary
             disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease
             (GOLD) guidelines 2005 and:

               1. Smoking history of at least 20 pack years

               2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30%
                  of the predicted normal value

               3. Post-bronchodilator FEV1/FVC (forced volume capacity) < 70% (Post refers to
                  within 30 minutes after inhalation of 400 μg of salbutamol)

                  Exclusion Criteria:

          -  Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to
             screening.

          -  Patients who had a respiratory tract infection within 6 weeks prior to screening.

          -  Patients with concomitant pulmonary disease.

          -  Patients with a history of asthma.

          -  Patients with diabetes type I or uncontrolled diabetes type II.

          -  Any patient with lung cancer or a history of lung cancer.

          -  Patients with a history of certain cardiovascular co-morbid conditions.

        Other protocol-defined inclusion/exclusion criteria applied to the study.
The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial
Condition: Delirium
MeSH terms: Delirium
Intervention: Ketamine (0.5 mg/kg); Normal Saline (placebo); Ketamine (1 mg/kg)
Intervention description: Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.; Normal saline IV following induction of anesthesia or administration of sedative medications; Low dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.
Intervention MeSH terms: Ketamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 746.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Delirium; ketamine; surgery; neurological complications

Summary:

      Delirium is a medical term or condition that includes a temporary inability to focus
      attention and to think clearly. Delirium occurs commonly (10% to 70%) in patients older than
      60 undergoing large surgeries. The purpose of this study is to test rigorously whether a drug
      called ketamine can decrease the chance that patients will experience delirium after their
      surgery. The investigators are also testing whether ketamine decreases postoperative pain,
      postoperative opioid consumption, postoperative nausea and vomiting, ICU and hospital length
      of stay, and adverse outcomes (e.g. hallucinations and nightmares).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 60 and older

          -  Competent to provide informed consent

          -  Undergoing major surgery (e.g., open cardiac surgery, open or thoracoscopic thoracic
             surgery, abdominal surgery, open urological surgery, open gynecological surgery, major
             orthopedic surgery, major vascular surgery including endovascular procedures, major
             ear, nose and throat surgery).

        Exclusion Criteria:

          -  Patients with an allergy to ketamine

          -  Those in whom a significant elevation of blood pressure would constitute a serious
             hazard (e.g., pheochromocytoma, aortic dissection)

          -  Unable to provide informed consent

          -  Patients with drug misuse history (e.g., ketamine, cocaine, heroin, amphetamine,
             methamphetamine, MDMA, phencyclidine, lysergic acid, mescaline, psilocybin)

          -  Patients taking anti-psychotic medications (e.g., chlorpromazine, clozapine,
             olanzapine, risperidone, haloperidol, quetiapine, risperidone, paliperidone,
             amisulpride, sertindole)

          -  Patients with a weight outside the range 50 kg - 200 kg (110 lbs - 440 lbs)
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Dapagliflozin; Placebo for dapagliflozin
Intervention description: Tablets; Tablets
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 833.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Dapagliflozin; Efficacy; Safety; Add on to insulin; Oral Antidiabetic; Type 1 diabetes

Summary:

      The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and
      effective therapy to improve glycemic control in patients with type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Type 1 Diabetes mellitus (T1DM)

          -  Central laboratory C-peptide < 0.7 ng/ml (0.23 nmol/L)

          -  Insulin use for at least 12 months per patient reported or medical records

          -  Method of insulin administration (MDI or CSII) must have been unchanged for at least 3
             months prior to screening

          -  Subjects must be on a total insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior
             to screening

          -  If on MDI insulin administration, subject must be on ≥ 3x injections per day

          -  Screening Visit: Central laboratory HbA1c ≥ 7.7% and ≤ 11.0%

          -  Body mass index (BMI) ≥ 18.5 kg/m2

        Exclusion Criteria:

          -  History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young
             (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased
             beta cell capacity

          -  Taking metformin and/or thiazolidinediones within 2 months prior to screening

          -  Taking any antidiabetic medication (other than insulin), within 1 month prior to
             screening

             - Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly
             administration and within 1 month prior to screening for once or twice daily
             administration

          -  History of diabetes ketoacidosis requiring medical intervention within 1 month prior
             to screening

          -  History of hospital admission for glycemic control (either hyperglycemia or
             hypoglycemia) within 1 month prior to screening

          -  Frequent episodes of severe hypoglycemia (more than one episode requiring medical
             assistance, emergency care), and/or glucagon therapy administered by a third-party
             individual within 1 month prior to screening

          -  History of Addison's disease
Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Levodopa-carbidopa intestinal gel; CADD-Legacy® 1400 ambulatory infusion pump; PEG tube; J-tube
Intervention description: Infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour).; percutaneous endoscopic gastrostomy tube; jejunal tube
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 354.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: severe motor fluctuations; levodopa; levodopa/carbidopa intestinal gel; efficacy; dyskinesia; Parkinson's Disease; carbidopa; DUOPA

Summary:

      The primary objective of this study will be to provide further evidence of the long-term
      safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in
      participants with advanced Parkinson's disease (PD) and severe motor fluctuations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease
             Society (UKPDS) Brain Bank Criteria

          -  Levodopa-responsive with severe motor fluctuations

          -  Recognizable off and on state (motor fluctuations) confirmed by diary

        Exclusion Criteria:

          -  Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as
             secondary parkinsonism

          -  Undergone surgery for the treatment of PD

          -  Contraindications to levodopa (such as narrow angle glaucoma)
12-week Efficacy of Indacaterol
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol 75 μg; Placebo to indacaterol
Intervention description: Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.; Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 323.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; indacaterol

Summary:

      This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as
             classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD]
             Guidelines, 2008) and:

               -  Smoking history of at least 10 pack-years

               -  Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30%
                  of the predicted normal value

               -  Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

        Exclusion criteria:

          -  Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or
             antibiotics and/or hospitalization in the 6 weeks prior to screening

          -  Patients who have had a respiratory tract infection within 6 weeks prior to screening

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of asthma

          -  Patients with diabetes Type I or uncontrolled diabetes Type II

          -  Any patient with lung cancer or a history of lung cancer

          -  Patients with a history of certain cardiovascular co-morbid conditions Other
             protocol-defined inclusion/exclusion criteria applied to the study.
Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico
Condition: Vaccines, Pneumococcal
Intervention: 13-valent pneumococcal conjugate vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 225.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study will be to evaluate safety, tolerability and immunogenicity of
      13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations
      in Mexico.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 2 month infants, available for entire study period and parent/legal guardian
             reachable by telephone

          -  Able to complete three blood draws during study

          -  At least 3.5 kg at enrollment

        Exclusion Criteria:

          -  Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to
             vaccines

          -  Immune deficiency, bleeding disorder or significant chronic medical condition