bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Exenatide on Cortisol Secretion
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary aim of the study is to describe the effect of single dose of 10 micrograms (μg)
      exenatide given subcutaneously (s/c) on cortisol secretion. Secondary outcomes involve ACTH
      and glucose levels.
    

Detailed description: 
      Exenatide is a short-acting Glucagon-Like Peptide receptor 1 (GLP-1 R) agonist.

      The clinical trial is conducted in10 healthy volunteers. Each subject receives one dose of
      subcutaneous exenatide (10 μg). After that, hormonal and physiological changes are measured
      during two hours. The blood samples are taken in 30-minute intervals.

      The primary endpoint is peak value of cortisol achieved during the 2 hours after drug
      administration.
    

Intervention name(s): Exenatide Injection
Intervention type(s): Drug
Intervention description(s): Single injection of Exenatide 10μg subcutaneously
Intervention MeSH terms: Exenatide
Intervention model: Single Group Assignment
Intervention model description: Single-group, open-label
Masking: None (Open Label)
Primary purpose: Diagnostic
A Safety Study of TTP4000 in Subjects With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to examine the safety, tolerability, immunogenicity and
      pharmacokinetics of TTP4000 in subjects with Alzheimer's disease with mild cognitive
      impairment.
    


Intervention name(s): TTP4000; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Performance During Menstrual Cycle
Condition: Performance
Study type: Observational

Summary: 
      This project aims to investigate if muscle strength and muscle power fluctuate during the
      menstrual cycle.

      The hypothesis is that the greatest performance will be measured right before ovulation, and
      at it's lowest on day 1 and 2 of the menstrual cycle in women not using any form for hormonal
      protection.

      And that the performance in women using birth control pills, not will variated in the period
      where they are taking pills (day 1-21).
    


Intervention name(s): estrogen level
Intervention type(s): Other
Intervention description(s): Women are tested at different times in their menstrual cycle, if there is a cohesion between performance and level of estrogen
Other intervention name(s): Physical tests
Intervention MeSH terms: Estrogens
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy women, 10 using 2. generations birth control pills and 30 not using any kind of
        hormonal protection.
      
Biospecimen description: 
      Blood
    
Keywords: menstrual cycle; Estrogen; performance; variation
Study to Evaluate the Safety and Efficacy TPI ASM8 in Subjects With Asthma
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The researchers propose to study the airways of asthmatics given TPI ASM8 for 14 days, and
      examine the protective effects on allergen-induced bronchoconstriction, hyperresponsiveness
      and airway inflammation.
    

Detailed description: 
      Early and late asthmatic responses were attenuated by ASM8 and by placebo
      solution.Methacholine challenge was not affected by study medication. Other parameters were
      unchanged.
    

Intervention name(s): TPI ASM8; placebo
Intervention type(s): Biological; Biological
Intervention description(s): Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each; Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Steroid-naive, non-smokers; Mild to moderate allergic asthmatic adults
Efficiency of Bumetanide in Autistic Children
Condition: Autistics Children
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if a treatment by bumetanide presents an efficiency
      at the level of the neuronal maturation in the autism
    


Intervention name(s): bumetanide
Intervention type(s): Drug
Intervention description(s): Administration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours)
Intervention MeSH terms: Bumetanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Autism; Bumetanide; GABA; NKCC1
Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects (DA-2811)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and
      DA-2811-R after a single oral dose in healthy volunteers.
    


Intervention name(s): DA-2811; DA-2811-R
Intervention type(s): Drug; Drug
Intervention description(s): single dose administration (one tablet once a day); single dose administration (one tablet once a day)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antipyretics for Preventing Recurrences of Febrile Seizures
Condition: Recurrence of Febrile Seizure
MeSH terms: Seizures; Seizures, Febrile; Recurrence; Hyperthermia; Fever
Study type: Interventional
Phase: Phase 4

Summary: 
      We wanted to find out if the early use of antipyretics is capable in preventing recurrences
      of febrile seizures. When a child has had his/her first febrile seizure, the parents were
      instructed to give him/her antipyretic medication every time when the child had a new episode
      of fever during two years.
    


Intervention name(s): Diclofenac, Paracetamol, Ibuprofen
Intervention type(s): Drug
Intervention description(s): Immediately if temperature > 38 degree Celsius, diclofenac suppository 1,5 mg/kg once or placebo suppository After eight hours, if temperature still < 38 degree Celsius, acetaminophen mixture 15 mg/kg up to four times a day, or ibuprofen mixture 10 mg/kg up to four times a day, or placebo mixture up to four times a day as long as temperature < 38 degree Celsius
Intervention MeSH terms: Acetaminophen; Ibuprofen; Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Mitigating Pain Following Refractive Surgery
Condition: Pain
Study type: Observational

Summary: 
      Using Contact lens following refractive procedure to reduce pain.
    

Detailed description: 
      Patients at day 1 following the procedure will be treated with a contact lens and assessed
      for pain at 1,2,4 hours and 1,3,5 days.

      prospective comparative study
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        at least 10 subjects following refractive surgery
      
Keywords: refractive surgery
Perioperative Management and Outcomes of Minimally Invasive Esophagectomy
Condition: Esophageal Cancer
Study type: Observational

Summary: 
      The investigators retrospectively reviewed the data of all patients who had undergone
      esophagectomy and reconstruction in 2015. Patient characteristics, the surgery performed,
      method of anesthesia, postoperative hospitalization course, and additional surgical
      interventions were reviewed and analyzed.
    


Intervention name(s): esophagectomy
Intervention type(s): Procedure
Intervention description(s): all the included participants had received esophagectomy, either Ivor Lewis or tri-incision, or more complex procedures.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with esophageal cancer undergoing esophageal reconstruction in 2015.
Use of Donepezil for Treatment of Cocaine Dependence
Condition: Cocaine Abuse and Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety of intravenous cocaine in subjects
      receiving oral donepezil.
    

Detailed description: 
      This is a randomized, double-blind, double-dummy, placebo controlled, inpatient,
      single-center, parallel group evaluation of the potential for oral donepezil to attenuate
      cocaine-induced craving. Non-treatment-seeking cocaine-experienced volunteers will receive
      baseline treatment with intravenous cocaine (30Mg). Forty-two subjects that tolerate baseline
      cocaine infusions will then receive two subsequent intravenous doses of cocaine during
      double-blind treatment with oral placebo or 5 mg daily of donepezil. Each dose of cocaine
      will be preceded or followed by administration of intravenous placebo (saline) in a random
      order.
    

Intervention name(s): Donepezil, 5 mg daily; Oral Placebo
Intervention type(s): Drug; Other
Intervention description(s): This is a commercially available cholinesterase inhibitor that is approved for use in Alzheimer's disease.; Inactive Comparator with Similar Appearance to Active Medication
Other intervention name(s): Aricept; Inactive Comparator
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acetylcholine; Acetylcholinesterase; Butyrylcholinesterase; Cholinesterase Inhibitor
Response Rate and Side Effects of Preoperative Chemotherapy (TOX Regimen) in Patients With Locally Advanced Operable Gastric Adenocarcinoma
Condition: Gastric Cancer
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Early stage diagnosis of gastric cancer has ensued different approaches in its resection
      strategies. In order to increase the proportion of cases that undergo radical resection and
      reduce the recurrence rate, different pre-operative treatments are introduced. Here, the
      investigators investigate an active preoperative chemotherapeutic regimen to in patients with
      locally advanced gastric cancer.
    


Intervention name(s): TOX
Intervention type(s): Drug
Intervention description(s): oxaliplatin 100mg/m2 IV over 2 hours at 1st day docetaxel 50 mg/m2 IV over 1 hour at 1st day capecitabine 625 mg/m2 PO for 14 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine
Condition: Diphtheria; Tetanus; Whooping Cough; Polio; Haemophilus Influenzae Type b
MeSH terms: Tetanus; Diphtheria; Whooping Cough; Tetany
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to assess the lot comparability of DAPTACEL, as well as the safety
      and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines.

      Stage I Primary Objectives:

        1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered
           with other recommended vaccines.

        2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of
           DAPTACEL when co-administered with other recommended vaccines.

        3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB
           concurrently administered in a different injection site with DAPTACEL when these
           vaccines are co-administered with other recommended vaccines.

      Stage II Primary Objectives:

        1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib
           or other infant vaccines.

        2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when
           co-administered with ActHIB in toddlers.
    

Detailed description: 
      This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and
      lot comparability of DAPTACEL
    

Intervention name(s): DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine); Pentacel: DTaP-IPV/Hib
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): DAPTACEL®; Pentacel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: DAPTACEL; Diphtheria; Tetanus; Whooping Cough; Polio; Haemophilus influenzae type b; Pertussis
Study of Acamprosate in Fragile x Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      In this research study we want to understand the effectiveness of a drug treatment,
      acamprosate, for interfering symptoms (i.e., inattention/hyperactivity, social impairment)
      associated with Fragile X Syndrome (FXS).
    

Detailed description: 
      Each subject with FXS will receive 10 weeks of blinded treatment with acamprosate or matching
      placebo. After completion of the double-blind phase, all subjects will have an opportunity to
      receive acamprosate as part of the study procedures for 16 weeks.
    

Intervention name(s): acamprosate; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Campral
Intervention MeSH terms: Acamprosate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Fragile X Syndrome
Pharmacokinetics And Relative Bioavailability Of Bococizumab (PF-04950615; RN316) When Administered To The Abdomen, Thigh Or Upper Arm
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to characterize the single dose pharmacokinetics of PF-04950616 following
      subcutaneous injection to the abdomen, upper arm or the thigh.
    


Intervention name(s): Bococizumab (PF-04950615; RN316); Bococizumab (PF-04950615; RN316); Bococizumab (PF-04950615; RN316)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single 150 mg PF-04950615 dose administered SC to the abdomen; Single 150 mg PF-04950615 dose administered SC to the upper arm; Single 150 mg PF-04950615 dose administered SC to the thigh
Intervention MeSH terms: Bococizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; bioavailability; PF-04950615
Intranasal Oxytocin and Enhancement of Team Cohesion
Condition: Unit Cohesion
Study type: Interventional
Phase: Phase 1

Summary: 
      This study attempts to identify the psychological, behavioral, physiological, and hormonal
      predictors and mechanisms of an individual's ability to develop cohesion in a group working
      together as a team; and examine if administration of the prosocial neuropeptide oxytocin
      enhances the development of team cohesion. Through a deeper understanding of the underlying
      psychobiological predictors and mechanisms of team cohesion, the prospective identification
      of individuals whose unique characteristics promote or inhibit the development of group
      cohesion will become possible.
    

Detailed description: 
      The investigators will study up to one thousand subjects who will be randomized into
      same-gendered teams of three or volunteer as acquainted groups of three . Teams will be
      randomized to receive oxytocin or placebo. The investigators will first measure baseline
      personality traits including prosocial orientation. Cohesion will then be measured using a
      cooperative, virtual unmanned aerial vehicle (UAV) flying mission. All online behavior will
      be recorded within the task and all offline, real world, behavior will be video recorded
      throughout the study by digital cameras for later behavioral coding. To measure biobehavioral
      synchrony, autonomic physiology will be recorded and saliva samples will be taken throughout
      behavioral testing.
    

Intervention name(s): Oxytocin; Placebo comparator
Intervention type(s): Drug; Other
Intervention description(s): 20 International Units Intranasal Oxytocin; Saline nasal spray
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SOLO arm and ECHO arm -- Acquainted, Unacquainted
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Cohesion; Oxytocin; Trust; Virtual-reality
A Study To Examine Safety, Pharmacokinetics, And Pharmacodynamic Of Pf 06412562 In Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the safety, tolerability pharmacokinetics and
      pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets
      in subjects with schizophrenia.
    

Detailed description: 
      B7441007 is a randomized, double-blind, placebo-controlled, sponsor open, parallel group
      design, Phase 1b study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      3 doses of PF-06412562 (3 mg BID, 9 mg BID and 45 mg BID) over 15 days in approximately 100
      psychiatrically stable (as defined by the inclusion and exclusion criteria) subjects with
      schizophrenia are on background treatment with SOC antipsychotics and other psychotropic
      medications.

      All doses will be administered twice daily, with approximately 12 hours between each dose.
    

Intervention name(s): PF-06412562 3mg BID; PF-06412562 9mg BID; PF-06412562 45mg BID; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): PF-06412562; PF-06412562; PF-06412562; Placebo
Other intervention name(s): PF-06412562 3mg; PF-06412562 9mg; PF-06412562 45mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars
Condition: Tertiary Dentine; Indirect Pulp Capping
MeSH terms: Dentin, Secondary
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to evaluate and compare the clinical effectiveness of 38% silver
      diamine fluoride with and without potassium iodide with that of resin modified glass ionomer
      cement in indirect pulp capping of young permanent molars.
    

Detailed description: 
      A sample of children with an age range of 6-9 years, having a first permanent molar erupted
      with deep occlusal carious lesion, will be selected from the outpatient clinic of Pediatric
      Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after
      securing necessary consents. All selected 108 first permanent molars will be randomly equally
      allocated into three groups according to capping material used. Group I (n=36) SDF/ KI and
      Group II (n=36) SDF and Group III (n=36) Glass ionomer cement. Indirect pulp capping
      treatment procedure will be performed with identical protocols except for the capping
      material to be used and its application will be according to manufacturer's instructions.
      Glass ionomer cement will be used as a base and resin-based composite restoration will be
      used in the three groups.
    

Intervention name(s): Silver diamine fluoride/ potassium iodide; Silver diamine fluoride; Resin modified glass ionomer cement
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Thirty six first permanent molars will receive 38% SDF/KI as an indirect pulp capping material.; Thirty six first permanent molars will receive 38% SDF as an indirect pulp capping material.; Thirty six first permanent molars will receive RMGIC as an indirect pulp capping material.
Other intervention name(s): SDF/KI; SDF; RMGIC
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a 3 arm clinical trial. All selected first permanent molars will be randomly equally allocated into three groups according to capping material used.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Silver diamine fluoride/ potassium iodide; glass ionomer cement
Forced Lefthandedness in Neonatal Brachial Plexus Palsy (NBPP) Children
Condition: Neonatal Brachial Plexus Palsy
MeSH terms: Neonatal Brachial Plexus Palsy
Study type: Observational

Summary: 
      The aim of the project is to assess the neurophysiological and functional consequences of
      forced lefthandedness in a population with right neonatal brachial plexus palsy (NBPP).
    

Detailed description: 
      A cross-sectional case-control study design to assess the neurophysiological and functional
      consequences of forced lefthandedness in a population with right neonatal brachial plexus
      palsy (NBPP). Controls are natural lefthanded typical developing children and
      adolescents.Case and controls are matched for age, gender and activity level.
    

Intervention name(s): Functional testing, Magnetic resonance imaging, Electromyography
Intervention type(s): Diagnostic Test
Intervention description(s): Electromyography only for cases (F-Lefthanders), not for controls (TD-lefthanders)
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Group 1 : healthy lefthanded typical developing children and adolescents with righthanded
        parents Group 2 : Forced lefthanded NBPP children and adolescents with righthanded parents
      
Keywords: upper limb paresis; developmental; functiona laterality