bioihbjkbjnl/mcl2 huggingface dataset:
Antioxidant Supplementation in Pregnant Women
Condition: Pregnant Women; Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to investigate the benefit of several micro nutrients of
      antioxidants (using milk) in a cohort of women with low antioxidant status and the changes in
      cell-free mRNA.
    

Detailed description: 
      Preeclampsia remains one of leading causes of maternal and perinatal mortality and morbidity.
      Despite intensive research, the cause of preeclampsia has not been established. One of the
      theories is exaggeration of systemic inflammatory that might induce reactive oxygen species
      (ROS). It has been proposed that pregnancy will progress uneventfully if adequate antioxidant
      exists to buffer ROS. The ROS can induce endothelial dysfunction which leads to clinical
      symptoms of hypertension and proteinuria in preeclampsia. Several large randomized clinical
      trials of antioxidant supplementation have concluded that there were no benefits of
      antioxidants supplementation for prevention of preeclampsia. However, there is limited
      information about benefits of antioxidants in women with low antioxidant status at early
      gestation that deprived of the antioxidant most. Our aim, therefore, in this study was to
      assess whether early supplementation with milk enriched with vitamin and mineral, such as Cu,
      Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium lowers the risk of
      preeclampsia in women with low antioxidant status at early gestation.
    

Intervention name(s): micronutrient antioxidant; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium; supplementation with milk
Other intervention name(s): antioxidant
Intervention MeSH terms: Micronutrients; Trace Elements; Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: antioxidant supplementation; preeclampsia
Study on Safety and Efficacy of Levetiracetam in the Adjunctive Treatment of Female Subjects With C1 Catamenial Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      The relationship between hormone cycling/fluctuations and the occurrence of seizures in women
      has received considerable discussion in the medical literature. This study investigated the
      efficacy and tolerability of LEV treatment for subjects with catamenial exacerbation of
      partial onset seizures.
    


Intervention name(s): Levetiracetam; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Keppra, ucbL059
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Levetiracetam; Keppra
Evaluation of Dupilumab in Children With Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To evaluate the efficacy of dupilumab in children 6 to less than (<) 12 years of age with
      uncontrolled persistent asthma.

      Secondary Objective:

      To evaluate in children 6 to <12 years of age with uncontrolled persistent asthma:

        -  The safety and tolerability of dupilumab.

        -  The evaluate the effect of dupilumab in improving participant reported outcomes
           including health related quality of life.

        -  The dupilumab systemic exposure and incidence of anti-drug antibodies.

        -  The evaluate the association between dupilumab treatment and pediatric immune responses
           to vaccines: any vaccination for tetanus, diphtheria, pertussis and/or seasonal
           trivalent/quadrivalent influenza vaccine.
    

Detailed description: 
      The total study duration per participant was up to 69 weeks, consisted of a screening period
      of 3-5 weeks, a randomized treatment period of 52 weeks and a post-treatment period of 12
      weeks.
    

Intervention name(s): Dupilumab; Placebo; Asthma Controller Therapies; Asthma Reliever Therapies
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: Solution
Route of administration: Subcutaneous; Pharmaceutical form: Solution
Route of administration: Subcutaneous; Pharmaceutical form: Aerosol, capsules, tablets, oral solution
Route of administration: Inhaled, oral; Pharmaceutical form: Nebulized, aerosol
Route of administration: Inhaled
Other intervention name(s): SAR231893 (REGN668)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans
Condition: Obstructive Sleep Apnea; Hypertension; Cardiovascular Diseases; Stroke
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Cardiovascular Diseases; Hypoxia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study has been designed to assess the effect of cyclooxygenase inhibition on blood
      pressure, cerebral blood flow, ventilation and renal hemodynamics following chronic
      intermittent hypoxia exposure.
    

Detailed description: 
      The study will specifically evaluate:

        1. Cardiovascular effect of cyclooxygenase inhibitors on cerebral, vascular, blood pressure
           and homeostatic responses following chronic intermittent hypoxia exposure.

        2. Ventilatory response of cyclooxygenase inhibitors following chronic intermittent hypoxia
           exposure

        3. Evaluate the renal hemodynamic effect of chronic intermittent hypoxia exposure and
           cyclooxygenase inhibition.
    

Intervention name(s): Intermittent hypoxia; Indomethacin; Celecoxib; Placebo
Intervention type(s): Other; Drug; Drug; Drug
Intervention description(s): The subjects will receive five days of drug intervention: either non-selective cyclooxygenase (Indomethacin) or selective cyclooxygenase-2 inhibition (Celecoxib) or placebo. On the testing day, the subjects will undergo an acute intermittent hypoxia testing before and six hours of hypoxic chamber exposure mimicking obstructive sleep apnea syndrome.; The subjects will receive five days of drug intervention: either non-selective cyclooxygenase (Indomethacin) or selective cyclooxygenase-2 inhibition (Celecoxib) or placebo. Then they will be tested with an exposure of intermittent hypoxia.
Indomethacin: 50 mg, Oral, three times per day for five days.; The subjects will receive five days of drug intervention: either non-selective cyclooxygenase (Indomethacin) or selective cyclooxygenase-2 inhibition (Celecoxib) or placebo. Then they will be tested with an exposure of intermittent hypoxia.
Celecoxib: 200 mg, Oral, two times per day for five days with a visually matching sequential placebo in between of two doses.; The subjects will receive five days of drug intervention: either non-selective cyclooxygenase (Indomethacin) or selective cyclooxygenase-2 inhibition (Celecoxib) or placebo. Then they will be tested with an exposure of intermittent hypoxia.
Placebo: Oral, three times per day for five days.
Other intervention name(s): Apo-Indomethacin; Celebrex
Intervention MeSH terms: Celecoxib; Indomethacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Obstructive Sleep Apnea; Hypoxia; Sleep; Blood Pressure; Hypertension; Myocardial Infarction; Stroke; Ventilation; Brain; Cerebral Blood Flow; Renal Blood Flow
Evaluation of the Effect Induced by Repeated Administration of Topical Local Anaesthetic (EMLA) on Itch
Condition: Lidocaine; Itch
Study type: Interventional

Summary: 
      In this experiment, the investigators would like to study if the repeated application of
      local cuaneous anaesthetic EMLA cream will reduce itch induced by small needles from the
      plant mucuna pruriens (also known as cowhage) and histamine (an itch proving substance formed
      in the body).
    


Intervention name(s): EMLA (lidocaine) +Itch (Histamine and cowhage)
Intervention type(s): Drug
Intervention description(s): Cutaneous anaesthesia: will be topically induced by using EMLA cream 5%, a local anaesthetic cream consisting of equal parts of lidocaine and prilocaine (1g contains 25 mg of lidocaine and 25 mg of prilocaine, AstraZeneca A/S, Albertslund, Denmark).
Histamine: To deliver histamine, standard allergy skin prick test (SPT) lancets are applied.
Cowhage: Cowhage spicules are 1-2 mm in length and have diameter of 1-3 um at their tip, once inserted into the epidermis, the spicules evoke a moderate sensation of itch and to a lesser extent sensations of burning and stinging pain.
Intervention MeSH terms: Lidocaine; Histamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Ingestion of Lipids and Changes in Cerebral Blood Flow of People With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study aims to determine changes in cerebral blood flow of people with obesity after the
      ingestion of fat.
    


Intervention name(s): 60 grams of fat plus water solution; Pure water
Intervention type(s): Other; Other
Intervention description(s): A solution composed by 60 grams of fat and water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
300 mL final volume of the solution.
Time of oral ingestion inferior than 2 minutes.
60 minutes before the radiopharmaceutical injection.
12 hours fasting minimum.; Pure water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
300 mL final volume of the solution.
Time of oral ingestion inferior than 2 minutes.
30 minutes before the radiopharmaceutical injection.
12 hours fasting minimum.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Obesity; Lipids; Single Photon Emission Computed Tomography; Functional Neuroimaging
A Rifampin Effect Study of SHR2554 on Healthy Chinese Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the effect of Rifampin on pharmacokinetics
      of healthy Chinese adult subjects after oral administration of SHR2554 tablets. The secondary
      objective of the study is to evaluate the safety of single-dose oral administration of
      SHR2554 in healthy subjects.
    


Intervention name(s): SHR2554 and Rifampin
Intervention type(s): Drug
Intervention description(s): Single-dose oral administration of SHR2554 and multiple-dose oral administration of Rifampin Capsules
Intervention MeSH terms: Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority
      of the meningococcal vaccine 134612 given with Priorix-Tetra.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      Open multicentre study with 4 treatment groups. Two groups will receive the 134612 vaccine
      with Priorix-Tetra either at the same or different visits followed by a second Priorix-Tetra
      vaccination at 84 days.

      Two control groups will receive Priorix-Tetra and Meningitec at different visits followed by
      a second Priorix-Tetra vaccination at 84 days.

      For all subjects, two blood samples will be taken: prior to and 42 days after the first
      vaccination. In a subset (30% of subjects in Groups A en C) from selected study centres:
      additional sample 42 days after second Priorix-Tetra dose.
    

Intervention name(s): Meningococcal vaccine GSK134612 (Nimenrix); Priorix-Tetra; Meningitec
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single dose intramuscular injection; 2-dose subcutaneous injection; Single dose intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: MMRV vaccine; co-administration; immunogenicity; meningococcal vaccine; conjugate vaccine
Postoperative Analgesic Effects of Dexmedetomidine for Transversus Abdominis Plane Block
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      the aim of this study is evaluate postoperative analgesic effects of dexmedetomidine added to
      bupivacaine on TAP block in patients undergoing lower abdominal surgery.
    

Detailed description: 
      TAP block is being used a method of multimodal balanced analgesia reduces postoperative pain,
      opioid requirement after surgery and adverse effect of opioid such as sedation, nausea
      vomiting and ileus. Dexmedetomidine ,an alfa-2 adrenoreceptor agonist, is being used and
      adjuvant capable of prolonging duration of sensory and motor block on nerve blocks.
    

Intervention name(s): Bupivacaine; Dexmedetomidine; serum physiologic
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 21 ml 0.5 %bupivacaine is applied interfasially; 1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied interfasially; 21 ml serum physiologic is applied interfasially
Other intervention name(s): marcaine; precedex
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TAP block; dexmedetomidine; bupivacaine; postoperative analgesia
Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects
Condition: Bioequivalence Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess bioequivalence between D961S and esomeprazole/buffered
      ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK)
      of D961S, esomeprazole and buffered ASA following repeated administration in healthy male
      Japanese subjects.
    

Detailed description: 
      A Phase I, Open label, Randomized, Single center, 2 way Crossover Bioequivalence Study
      Comparing D961S (a Fixed-dose Combination Capsule of Esomeprazole 20 mg and Acetylsalicylic
      Acid 81 mg) with a Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic
      Acid Tablet 81 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
    

Intervention name(s): D961S; Esomeprazole; Buffered acetylsalicylic acid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral gelatine capsule; Oral HPMC capsule; Tablet
Other intervention name(s): Nexium® capsule 20 mg; Bufferin Combination Tablet A81
Intervention MeSH terms: Aspirin; Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteer, Japanese males, homo-EM
Effect of Designed Physical Training After Selective Dorsal Rhizotomy on Motor Function of Ambulant Children With Spastic Diplegia
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The management of cerebral palsy is complex and requires a multidisciplinary approach.
      Selective dorsal rhizotomy is a neurosurgical technique that aims to reduce spasticity in the
      lower limbs and improve motor function.
    

Detailed description: 
      the current study is designed to assess the effectiveness of Selective dorsal rhizotomy on
      motor function in ambulant children with spastic diplegia. therefore, A convenient sample of
      ambulant children with spastic diplegia will be allocated to two groups of equal numbers
      (control and experimental)
    

Intervention name(s): Concomitant physical rehabilitation; Standard Orthotic Management; selective dorsal rhizotomy
Intervention type(s): Other; Other; Other
Intervention description(s): Children of this group will receive a regular exercise rehabilitation program including starching exercises, functional strength training and static and dynamic balance exercises.The program will be conducted by six licensed pediatric physical therapists for one hour/session, 3 times/week, and six successive months.; A custom-made articulating ankle foot orthosis was prescribed with a hinge at the level of the medial malleolus extends distally to the tip of the toes and proximally on the posterior surface of the leg to about 5 cm below the knee and secured straps. It is fabricated to permit free ankle dorsiflexion and lock the plantar flexion at 0 dorsiflexion. The splinting schedule started gradually for 2 h/day in the first month, 4 h/day in the second month to the entire wake-up time of the day.; The surgical procedures were tailored to each child according to preoperative assessment plan. All SDRs were performed by a single neurosurgeon through an osteoplastic laminotomy from L2 to L5 that left the facet joints intact.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: standard orthotic management; Selective dorsal rhizotomy; Bilateral Cerebral Palsy; Functional balance; Energy Cost of Walking; Functional capacity; Selective voluntary motor control:
Flow Mediated Dilation in Response to Black Tea
Condition: Vascular Function
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      Research indicate that people who regularly drink tea have a reduced risk of stroke or heart
      disease. In a number of studies in which people that normally do not drink showed that their
      blood vessels function improved when the drunk tea. The current study tests whether a
      specific black tea improves vessel function in non-tea drinking hypertensive subjects.
    

Detailed description: 
      Epidemiological studies indicate that regular consumption of three cups of black tea per day
      reduces the risk of stroke or myocardial infarction. In a number of previous nutrition
      intervention studies tea has been shown to improve vascular function as assessed by Flow
      Mediated Dilation in various populations. The current confirmatory study tests a specific
      black tea against a placebo in a population of in non-tea drinking hypertensive subjects.
    

Intervention name(s): Tea; Placebo
Intervention type(s): Other; Other
Intervention description(s): Single dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar.; Placebo: tea flavour, colouring and sugar
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Flow mediated dilation; tea; blood pressure
hOKT3γ1 (Ala-Ala) Combined With Sirolimus and Delayed Tacrolimus in Type 1 Diabetic Islet Allograft Recipients
Condition: Type 1 Diabetes; Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The collective effects of two-layer pancreas preservation, pretransplant islet culture, day
      -2 pretransplant immunosuppression, and induction immunosuppression with the FcR-nonbinding
      anti-CD3 monoclonal antibody hOKT3γ1 (Ala-Ala)to facilitate diabetes reversal after
      single-donor islet transplantation.
    

Detailed description: 
      This is an open-label, one-year follow-up study of type 1 diabetic islet allograft recipients
      who receive FcR non-binding OKT3 antibody hOKT3γ1 (Ala-Ala) plus sirolimus induction
      immunotherapy combined with sirolimus and delayed tacrolimus maintenance immunosuppression.
      Six subjects were transplanted.

      The premise behind the proposal is that hOKT3γ1(Ala-Ala) corrects the imbalance between
      autoreactive and regulatory T cells and consequently prevents autoimmune destruction of
      transplanted islets. To prevent allorejection, hOKT3γ1(Ala-Ala)was combined with sirolimus
      and delayed tacrolimus. Additionally, the safety and efficacy of the maintenance
      immunosuppressive regimen of sirolimus combined with tacrolimus was monitored.
    

Intervention name(s): Allogeneic Islets of Langerhans; hOKT3γ1 (Ala-Ala)
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Healthy Volunteers, Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] AZD8931
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to Assess the Absorption, Metabolism and Excretion of [14C]AZD8931 after a Single-Dose
      Oral Administration
    


Intervention name(s): [14C] AZD8931
Intervention type(s): Drug
Intervention description(s): Single 160 mg oral dose administered on Day 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Radioactive carbon; Absorption; Distribution; Metabolism; Excretion; Healthy Volunteers
Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?
Condition: Seborrheic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis; Keratosis, Seborrheic
Study type: Interventional

Summary: 
      Seborrheic keratoses (SK's) are very common, but harmless skin lesions that commonly appear
      during adult life. Patients with seborrheic keratoses frequently desire treatment due to
      symptoms of itching and irritation or for cosmetic purposes. Seborrheic keratoses can be
      easily removed and have been treated in a number of different ways. Two of the simplest and
      most successful ways to remove seborrheic keratoses are cryosurgery and curettage.

      The investigators are conducting this study to see which of these two treatments has the best
      result.

      Approximately 24-30 people will take part in this research study at the Hershey Medical
      Center.
    


Intervention name(s): cryosurgery; Curettage
Intervention type(s): Procedure; Procedure
Intervention description(s): freezing of lesion with liquid nitrogen; the lesion will be anesthetized and destroyed with a curette.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: seborrheic keratoses; cryosurgery; curettage