bioihbjkbjnl/mcl2 huggingface dataset:
Intraperitoneal Bupivacaine With Magnesium or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy
Condition: Anesthesia
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare between the addition of Mg sulphate or Nalbuphine to
      intraperitoneal bupivacaine installation in laparoscopic hysterectomy for postoperative pain
      control and their relative adverse effects.
    


Intervention name(s): Bupivacaine 0.25%; Magnesium sulphate.; nalbuphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%; Patients will receive intraperitoneal 30 mg/kg of magnesium sulphate.; Patients will receive intraperitoneal 5 mg nalbuphine
Other intervention name(s): opioid
Intervention MeSH terms: Magnesium Sulfate; Nalbuphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of 2 Doses of Tiotropium Respimat Compared to Placebo in Adolescents With Severe Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation
      solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks,
      compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to
      17 years old) with severe persistent asthma.

      The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and
      possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary
      function endpoint after 12 weeks of treatment.

      Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints,
      and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy
      on top of usual care in this patient population.
    


Intervention name(s): tiotropium high dose; placebo; tiotropium low dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 actuations once daily; 2 actuations once daily; 2 actuations once daily
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Prevention of Type 2 Diabetes in Children With a Family-based Healthy Lifestyle Program
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the Bright Bodies (BB) Healthy Lifestyle Program
      can help reverse early abnormalities in glucose metabolism and prevent the progression to
      type 2 diabetes (T2DM) in high-risk, obese youth with newly-diagnosed impaired glucose
      tolerance (IGT).
    

Detailed description: 
      Primary Aim: (1) To determine whether youth randomized to the Bright Bodies (BB) Healthy
      Lifestyle Program have lower 2-hr plasma glucose levels than those randomized to standard
      lifestyle counseling (control) after 6 months.

      Secondary Aims: (2) To determine if greater conversions from IGT to normal glucose tolerance
      (NGT) and less development of T2DM occurs for those in the BB vs Control Group; (3)To
      determine if there is improvement in anthropometric/metabolic parameters in BB vs Control
      Group; and (4) To determine if there is an improvement in psychosocial and family dynamic
      outcomes of the child in BB vs Control Group.
    

Intervention name(s): Bright Bodies Healthy Lifestyle Program; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects attend program with a caregiver or parent twice per week for 6 mos. Exercise is 2x/wk, behavior mod/nutrition 1 x/wk, and parent class 1 x/wk. Smart Moves curriculum is utilized for nutrition and behavior mod.; Subjects will be given basic instruction by clinical provider and goals will be followed up every 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Impaired Glucose Tolerance; PreDiabetes; Diabetes Prevention
A Proof of Concept Study of Electrical Discharge Produced Nitric Oxide for Inhalation
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary
Study type: Interventional

Summary: 
      Study Design: This is a two-part physiological for a device feasibility. Both studies are
      proof of concept descriptive pilot studies.

      The FIRST PART is a study of healthy volunteers and the SECOND PART of patients with
      pulmonary hypertension at routine cardiac catheterization laboratory (CATH-LABORATORY).

      Volunteers and patients will be enrolled sequentially; there is no group randomization.

      Overall hypothesis of this device feasibility study: To test a lightweight and portable
      method of synthesizing therapeutic levels of inhaled nitric oxide from air by electrical
      pulsed discharge.
    

Detailed description: 
      Background. Inhaled nitric oxide is routinely used to treat acute pulmonary hypertension in
      infants, children and adults. By 2014 it has been estimate about 500,000 US patients have
      been treated with nitric oxide, with only the rare complication of methemoglobinemia reported
      at high inhaled doses.

      Rationale. The investigators explored novel alternative lightweight and economical methods of
      local nitric oxide production. In particular the investigators synthesized nitric oxide from
      air by an electrical pulsed plasma discharge. After 2 years of study the investigators have
      designed and produced a prototype of a device synthesizing nitric oxide from air with low
      levels of nitrogen dioxide and ozone. After completing experimentation in lambs, the
      investigators now plan to study nitric oxide generators in a proof of concept clinical study.

      Design of the study: The study is comprised of two parts:

        1. HEALTHY volunteer study, and

        2. CATH-LABORATORY study in patients.

      The study will be conducted at low levels of breathing nitric oxide, 25 parts per million of
      nitric oxide, for 20 minutes to comply with the threshold of the Environmental Protection
      Agency (EPA) for daily work exposure.

      The first portion of the study will be carried out in 6 healthy volunteers breathing 25 parts
      per million of nitric oxide. After this first part, the investigators will proceed to the
      second portion of the study and enroll 6 patients with pulmonary hypertension undergoing
      scheduled testing with a nitric oxide-pulmonary vasodilator response (CATH-LABORATORY study).
    

Intervention name(s): electrical pulsed plasma discharge synthesis of nitric oxide
Intervention type(s): Device
Intervention description(s): An NO generator was designed and developed by electrical pulsed plasma discharge nitric oxide from atmospheric nitrogen and oxygen. This generator has been fabricated by the investigators and it is not commercially available.
Intervention MeSH terms: Nitric Oxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Nitric Oxide
Comparison of Loading Dose Magnesium Sulphate With Prichard Regimen in the Management of Severe Preeclampsia and Eclampsia.
Condition: Severe Pre-eclampsia; Eclampsia
MeSH terms: Pre-Eclampsia; Eclampsia
Study type: Interventional

Summary: 
      Preeclampsia/eclampsia is part of a spectrum of multi-systemic pregnancy disorder that
      contributes substantially to maternal and perinatal morbidity and mortality, especially in
      low resource setting. This study was done in Abakaliki, Ebonyi State, Southeast Nigeria.

      To compare the efficacy of loading dose of magnesium sulphate with that of the Pritchard
      regimen in the prevention of eclampsia in severe preeclampsia and recurrent fits in eclampsia
      in a low resource setting.

      A prospective, single blinded randomized controlled study of loading dose versus Pritchard
      regimens of MgSO4 at the Teaching Hospital Abakaliki. One hundred and twenty patients were
      recruited 60 to each arm using computer-generated numbers. Sociodemographic characteristics,
      efficacy and adverse effects of the drug on the mother and baby were noted.
    

Detailed description: 
      Background: Preeclampsia/eclampsia is part of a spectrum of multi-systemic pregnancy disorder
      that contributes substantially to maternal and perinatal morbidity and mortality, especially
      in low resource setting. This study was done in Abakaliki, Ebonyi State, Southeast Nigeria.

      Objectives: To compare the efficacy of loading dose of magnesium sulphate with that of the
      Pritchard regimen in the prevention of eclampsia in patients with severe preeclampsia and
      recurrent fits in eclampsia in a low resource setting like ours.

      Methods: This was a prospective, single blinded randomized controlled study of loading dose
      versus Pritchard regimens of MgSO4 at Alex Ekwueme Federal University Teaching Hospital
      Abakaliki. One hundred and twenty patients were recruited 60 to each arm using
      computer-generated numbers. Social demographic characteristics, efficacy and adverse effects
      of the drug on the mother and baby were noted. Data were collated, tabulated and analyzed
      using the statistical package for social sciences (SPSS) software (version 22, Chicago II,
      USA)
    

Intervention name(s): Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia
Intervention type(s): Drug
Intervention description(s): Loading dose magnesium sulfate versus the Pritchard regimen
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prevention of Eclampsia in severe pre-eclampsia and further fits in Eclampsia.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pre-eclampsia; Eclampsia; magnesium sulphate
Effect of Spirulina on Serum Hyaluronic Acid in Beta Thalassemic Children With Hepatitis C
Condition: Beta Thalassemia Major
MeSH terms: Hepatitis C; Thalassemia; beta-Thalassemia
Study type: Interventional

Summary: 
      Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection.
      The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics.
      Excess liver iron is clearly recognized as a co factor for the development of advanced
      fibrosis in patients with hepatitis virus C infection. Hyaluronic acid serum levels correlate
      with histological stages of liver fibrosis in hepatitis C patients, so it has a good
      diagnostic accuracy as a non invasive assessment of fibrosis and cirrhosis.there is evidence
      that suggests Spirulina may help to protect against liver damage, cirrhosis and liver failure
      in those with chronic liver disease.
    


Intervention name(s): Spirulina
Intervention type(s): Dietary Supplement
Intervention description(s): Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule
Condition: CYP450 Phenotyping
Study type: Interventional

Summary: 
      Healthy Subjects will receive treatment orally with 120-200ml tap water in fasted state.

      Treatment in period A is the "Basel phenotyping cocktail" capsule. Treatment in period B
      consists of simultaneous intake of isolated formulations. In both study arms peripheral
      venous and capillary blood (DBS) samples will be drawn
    


Intervention name(s): "Basel phenotyping cocktail" capsule; "Basel phenotyping cocktail" individual components
Intervention type(s): Other; Other
Intervention description(s): Oral intake of "Basel phenotyping cocktail" capsule and pharmacokinetics (PK) sampling; Oral intake of "Basel phenotyping cocktail" individual components and PK sampling
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety Study of BMS-986165 in Healthy Subjects and to Treat Psoriasis
Condition: Healthy Subjects
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish if BMS-986165 is safe and effective at treating
      autoimmune diseases. BMS-986165 which has shown some promise in preclinical studies for
      inhibiting autoimmune conditions. This study will be the first time this drug is given to
      humans, and will be conducted entirely in healthy subjects. It will be run in 4 Parts. Part A
      will investigate single oral doses of drug. Part B will investigate giving the drug daily for
      14 days. Part C will investigate daily doses for 14 days in healthy volunteers with Japanese
      decent. Part D will investigate whether food, stomach acidity or giving the drug in a capsule
      makes a difference to the safety and potential use of this drug.
    


Intervention name(s): BMS-986165; Interferon alpha-2a recombinant; Famotidine; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Deucravacitinib; Famotidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Efficacy and Safety Study of Kinerase® for Treatment of Cutaneous Facial Photodamage
Condition: Skin Roughness; Mottling; Blotchiness; Pigmentation; Fine Wrinkles
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the K.I.S.S. study is to evaluate the efficacy of Kinerase® Cream (Kinetin
      0.1%) in Thai patients, on the basis of the severity and clinical signs of facial
      photodamage.
    


Intervention name(s): Kinerase
Intervention type(s): Other
Intervention MeSH terms: Kinetin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1 Study to Evaluate ASN002 Absorption, Metabolism, and Excretion of [14C] Following a Single Oral Dose in Healthy Male Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C] ASN002
      Following a Single Oral Dose in Healthy Male Subjects
    

Detailed description: 
      This will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male
      subjects. Subjects will be admitted into the Clinical Research Unit (CRU) on Day 1 and be
      confined to the CRU until at least Day 7. On Day 1, subjects will receive a single oral dose
      of [14C] ASN002 at 60 mg containing approximately 300 μCi [14C] ASN002. Subjects will be
      discharged on Day 7 if the following discharge criteria are met: plasma radioactivity levels
      below the limit of quantitation for 2 consecutive collections, and ≥90% mass balance
      recovery, or ≤1% of the total radioactive dose is recovered in combined excreta (urine and
      feces) in 3 consecutive 24 hour periods. If discharge criteria are not met by Day 7, subjects
      will remain in the CRU up to a maximum of Day 10.
    

Intervention name(s): [14C] ASN002
Intervention type(s): Drug
Intervention description(s): [14C] ASN002
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of Olanzapine in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objectives of the study is to confirm if the efficacy of intramuscular injection
      (IM) olanzapine 10 milligrams (mg) in patients with an exacerbation of schizophrenia with
      acute psychotic agitation is greater than intramuscular placebo by comparing changes from
      baseline to 2 hours after the first IM injection of agitation.
    


Intervention name(s): Rapid-Acting Intramuscular Olanzapine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections; Administered by means of IM with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections
Other intervention name(s): LY170053; RAIM
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Lipophilic Versus Hydrophilic Statins on Patients With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      There is a controversy whether statins are beneficial in patients with heart failure or not.
      Trials in which lipophilic statins have been used revealed positive results, unlike major
      studies where hydrophilic statins were administered. This trial is designed to compare the
      effects of lipophilic versus hydrophilic statin use in patients with heart failure.
    


Intervention name(s): Atorvastatin; Rosuvastatin; guideline directed therapy
Intervention type(s): Drug; Drug; Other
Intervention description(s): Atorvastatin administered as well as standard heart failure therapy; Rosuvastatin administered as well as standard heart failure therapy; standard heart failure therapy
Other intervention name(s): standard heart failure therapy; standard heart failure therapy
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: statin; hydrophilic; lipophilic
A Clinical Trial to Compare the Pharmacokinetic and Safety of CKD-828 20/1.25mg
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical trial to compare the pharmacokinetic and safety of CKD-828 20/1.25mg
    

Detailed description: 
      A randomized, open-label, single dose, 4-period replicate crossover study to evaluate the
      pharmacokinetic profiles and safety of CKD-828 in healthy volunteers under fasting conditions
    

Intervention name(s): CKD-828, D064, D702
Intervention type(s): Drug
Intervention description(s): QD, PO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
Condition: Leiomyoma; Uterine Hemorrhage
MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the superiority of ulipristal acetate versus placebo for the
      treatment of abnormal uterine bleeding associated with uterine fibroids
    


Intervention name(s): Ulipristal acetate (UPA); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): UPA tablet; Matching placebo tablet.
Intervention MeSH terms: Ulipristal acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Multiple Doses of Danicopan in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a multiple ascending dose, randomized, double-blind study assessing the safety,
      tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants.
      Four different doses (75 milligrams [mg], 200 mg, 500 mg, 800 mg) and dose-matched placebo
      were administered under fasted conditions.
    


Intervention name(s): Danicopan; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): ACH-0144471 (formerly); ALXN2040; ACH-4471; ACH4471; 4471
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Danicopan; ALXN2040; ACH-0144471; Factor D Inhibitor; Pharmacokinetics; Pharmacodynamics; Ascending Dose
Whole Body Vibration Therapy in Participants With MS Related Balance Deficits
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this investigation is to determine the effect of Whole Body Vibration Therapy
      (WBV) on balance in participants with multiple sclerosis (MS) related balance deficits as
      measured by the NeuroCom Balance Master, the Sapphire IIME EMG Device and the Kurtzke
      Expanded Disability Status Scale (EDSS) and the Berg Balance Score.
    


Intervention name(s): Whole Body Vibration machine
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: MS; Balance; Multiple Sclerosis