bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Safety and Immune Response of an H7N7 Vaccine in Healthy Adults
Condition: Influenza A Subtype H7N7 Infection
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      H7N7 is one type of influenza virus that may pose a threat to humans if an outbreak occurs.
      This study will evaluate the safety and immune response to an H7N7 vaccine in people who have
      previously received a live attenuated influenza vaccine (LAIV) as part of a research study
      and people who have not previously received a LAIV.
    

Detailed description: 
      Influenza A viruses are widely found in nature and can infect a wide variety of birds and
      mammals, including humans. Some types of influenza A viruses are more likely to spread from
      animals to humans, and researchers are interested in monitoring these viruses and developing
      potential vaccines for them. H7N7 is one type of influenza A virus. In recent years, there
      have been several H7N7 outbreaks among humans, and the development of an H7N7 vaccine is a
      high priority. This study will enroll two groups of participants: people who have previously
      received one of three types of a pandemic LAIV as part of a research study and people who
      have not previously received a LAIV vaccine. The purpose of this study is to evaluate the
      safety and immunogenicity of a single dose of an inactivated H7N7 vaccine in these two groups
      of participants.

      At a baseline study visit, all participants will undergo a medical history review, physical
      examination, vital sign measurements, blood collection, and nasal secretion collection.
      Female participants will provide a urine sample for pregnancy testing. All participants will
      then receive one intramuscular (IM) injection of the H7N7 study vaccine in their upper arm.
      They will remain in the clinic for 30 minutes for observation and monitoring. Participants
      will monitor and record any adverse symptoms between study visits. Additional study visits
      will occur at Days 4, 7, 14, 28, 56, and 180. At select study visits, participants will
      undergo a medical history review, physical examination, and nasal secretion collection. Blood
      collection will occur at each visit; some blood samples may be stored for future research.
    

Intervention name(s): Monovalent Influenza Subvirion Vaccine, H7N7
Intervention type(s): Biological
Intervention description(s): At study entry, all participants will receive one IM injection of approximately 45 micrograms of inactivated Monovalent Influenza Subvirion Vaccine, H7N7.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Mono-center Study in Healthy Volunteers on the Comparative Bioavailability of Pletal 100 mg Tablets and a New Pletal 100 mg Orodispersible Tablet (ODT), This Latter in Fasting Conditions With and Without Water and Under Fed Conditions
Condition: Intermittent Claudication
MeSH terms: Intermittent Claudication
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to test whether Pletal ODT administered without water
      can be considered bioequivalent to Pletal administered with 200 ml water (both treatments
      being administered after fasting and at least 30 minutes prior to receiving a light
      breakfast) based on the standard pharmacokinetic variables.

      The secondary objective is to assess the effect of water and the effect of food on the
      administration of Pletal ODT based on standard pharmacokinetic variables.
    


Intervention name(s): Cilostazol
Intervention type(s): Drug
Intervention description(s): 100 mg Cilostazol
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed pilot study will estimate the efficacy and safety of a novel therapeutic agent,
      cabergoline, with a clinical standard therapy, norethindrone acetate, for the treatment of
      endometriosis-associated pain in young women with endometriosis.
    


Intervention name(s): Cabergoline; Norethindrone acetate
Intervention type(s): Drug; Drug
Other intervention name(s): Dostinex; Aygestin
Intervention MeSH terms: Cabergoline; Norethindrone; Norethindrone Acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
KTP (Potassium-titanyl-phosphate) Laser Versus TUR-P (Transurethral Resection of Prostate)
Condition: BPH (Benign Prostatic Hyperplasia)
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      The purpose of this study is to compare safety and efficacy of Green Light PVP
      (Photoselective Vaporisation of the Prostate) compared to TUR-P.
    


Intervention name(s): Green light Laser; Transurethral Resection of the Prostate (TURP)
Intervention type(s): Device; Device
Intervention description(s): Laser vs TURP; Laser vs TURP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Compare PK, PD and Safety of CKD-381 and D026 in Healthy Subjects
Condition: GERD
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy subjects
    


Intervention name(s): CKD-381; D026
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet administered before the breakfast during 7 days; 1 tablet administered before the breakfast during 7 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: CKD-381; D026
Hyaluronic Acid, Corticosteroid and Electrotherapy in Subacromial Impingement Syndrome
Condition: Subacromial Impingement; Pain, Shoulder
MeSH terms: Shoulder Impingement Syndrome; Shoulder Pain
Study type: Interventional

Summary: 
      Background: Electrotherapy, corticosteroid, and hyaluronic acid have been used to treat
      subacromial impingement syndrome. However, we need to compare treatment options to provide
      the optimal results. This study aims to compare the effect of hyaluronic acid,
      corticosteroid, and electrotherapy in subacromial impingement syndrome.

      Design: Ninety five patients were randomised into three equal groups according to treatment
      types. Hyaluronic acid (20 mg/2ml, three times one week apart) or corticosteroid
      (triamcinolone acetonide, 40 mg/ml, single dose) treatments were applied as subacromial
      injections. Electrotherapy consisted of 14 sessions TENS (20 min.), hotpack (20 min.) and
      ultrasound (1.5watt/cm2, 1 MHz, 6 min.). Patients were evaluated before treatment, one and
      four weeks post end of treatment. Visual Analogue Scale (VAS), range of motion (ROM), and
      Shoulder Disability Questionnaire (SDQ) were used as outcome measures.
    


Intervention name(s): Hyaluronic acid; Corticosteroids Triamcinolone Acetonide; Electrotherapy
Intervention type(s): Drug; Drug; Other
Intervention description(s): triamcinolone acetonide, 40 mg/ml, single dose; electrotherapy
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Hyaluronic Acid; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults
Condition: Yellow Fever (Healthy Volunteers)
MeSH terms: Yellow Fever; Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of the study are:

        -  To describe the safety profile of each of the 3 dosages of vYF and of YF-VAX® within the
           28 days post-vaccination and up to the 6 months (Day 180) post-vaccination visit

        -  To describe the antibody responses elicited by each of the 3 dosages of vYF and by
           YF-VAX on Day 0 pre-vaccination and then on Day 10, Day 14, Day 28 and 6 months (Day
           180) post-vaccination overall and by baseline flavivirus serostatus

        -  To quantify the detectable yellow fever (YF) vaccinal viremia in each vaccine groups
           (vYF and YF-VAX) in a subset of subjects on Day 0 visit, Day 1 visit, Day 3 visit, Day 5
           visit, Day 7 visit, Day 10 visit, and Day 14 visit.
    

Detailed description: 
      Study duration per participant is approximately 6 months.
    

Intervention name(s): Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine; Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccine; Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine; Yellow fever vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous; Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous; Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous; Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
Other intervention name(s): YF-VAX
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY2963016 to Lantus in Healthy Participants
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of
      LY2963016 compared to those of basal insulin. The study will also gather information on the
      safety and tolerability of LY2963016 in healthy participants.

      Each study period will be approximately 8.5 days (1.5 days for treatment and 7 day washout
      period). There are 4 study periods.
    


Intervention name(s): LY2963016; Lantus
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously; Administered subcutaneously
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for Acne Treatment
Condition: Monitor Acne Lessions Count Reduction as Result of Usinfg the Device
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      This is a clinical research study to determine the ability of the Clear device to treat mild
      to moderate inflammatory acne, and to determine if the average person is able to use the
      device properly according to the labeling as describe in the operator manual.

      The study involve treatments twice a week over 4 weeks total of 8 treatment sessions, in
      which the subjects will be treating themselves with the Clear device, and 2 follow-up visits
      to evaluate the results. The clinical result will be assessed by the investigator for
      improvement in the acne condition. Treatment will be performed on the face of subjects
      enrolled and who meet the inclusion criteria.
    

Detailed description: 
      The subjects will be recruited if they are eligible to participate in the study according
      with the device labeling presented at the doctor's office by printed ads. Subjects will be
      given information about the Clear device according to its labeling. After reading the
      information and labeling, it will be the subjects' decision if they understand the device
      label information and if they want to participate in the study. The investigator will review
      the inclusion / exclusion criteria with the subjects to ensure eligibility.
    

Intervention name(s): light based device for treatment of acne
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acne, LED, blue light
Pneumonia in Tetanus Study
Condition: Tetanus
MeSH terms: Pneumonia; Tetanus; Tetany
Study type: Interventional

Summary: 
      This is a randomised controlled trial of the incidence of nosocomial pneumonia in patients
      with severe tetanus admitted to the intensive care ward nursed in a supine or semi-recumbent
      position.
    

Detailed description: 
      Background: Hospital-acquired pneumonia remains a common and important cause of morbidity and
      mortality in patients with severe tetanus who require a tracheostomy whether or not they are
      mechanically ventilated. We propose to investigate if the incidence of hospital-acquired
      pneumonia can be reduced by nursing tetanus patients semi-recumbent at 30o rather than supine
      as is the current practice.

      The aim of this study will be to assess the frequency of clinically suspected and
      microbiologically confirmed hospital acquired pneumonia in patients nursed in a
      semi-recumbent or supine body position. A secondary end-point will be the mortality in each
      group. Patients at risk of developing hospital acquired pneumonia (in hospital without
      developing pneumonia for more than two days) will be evaluated
    

Intervention name(s): semi-recumbent; supine
Intervention type(s): Other; Other
Intervention description(s): Patient rests in a semi-recumbent body position; Patient rests in a supine position
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
A Pilot Study Exploring the Efficacy and Safety of Topical Oxybutynin 3% Gel for Primary Focal Hyperhidrosis in Adolescents and Young Adults
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      This is a single-center, prospective, open-label, outpatient pilot study evaluating the
      efficacy and tolerability of oxybutynin gel for axillary hyperhidrosis.
    

Detailed description: 
      This study will determine if daily application of topical oxybutynin 3% gel reduces the
      symptoms of primary axillary hyperhidrosis in adolescents and young adults. It will also
      assess the impact of daily topical oxybutynin 3% gel on Health Related Quality of Life
      (HRQOL); determine if daily topical oxybutynin 3% gel has a treatment effect at distant,
      untreated sites; and assess the local and systemic tolerability of daily topical oxybutynin
      3% gel. Finally, the study will determine the treatment effect size, if one exists, in order
      to power a larger, placebo-controlled study in the future.
    

Intervention name(s): Oxybutynin 3% gel
Intervention type(s): Drug
Other intervention name(s): Gelnique
Intervention MeSH terms: Oxybutynin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess Dystrophin Levels in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD)
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the ability of ataluren to increase dystrophin protein
      levels in muscle cells of participants with nmDMD. The study will evaluate the levels of
      dystrophin before and after 40 weeks of ataluren therapy using muscle biopsies and 2
      validated assay methods, electrochemiluminescence (ECL) and immunohistochemistry.
    


Intervention name(s): Ataluren
Intervention type(s): Drug
Intervention description(s): Ataluren will be administered as per the dose and schedule specified in the arm.
Other intervention name(s): PTC124
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Natriuretic Peptide's Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
Condition: Headache; Migraine
MeSH terms: Headache
Study type: Interventional

Summary: 
      To investigate headache score and accompanying symptoms during and after infusion of the
      natriuretic peptides.
    


Intervention name(s): Natriuretic peptides
Intervention type(s): Drug
Intervention description(s): I.V. infusion between 0.2-3 microgram over 20 minutes
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Omega-3 Fatty Acid for Critically Ill Patients.
Condition: Sepsis
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Sepsis is the most common reason for intensive care unit (ICU) admission. Sepsis flares up
      the systemic inflammatory response with its mediators. Sepsis treatment protocols have been
      established in many centres with immune nutrient as adjuvant treatment. Omega-3 fatty acid
      and other anti-oxidants formulae have been found to improve sepsis outcome. In most of the
      studies, immune nutrients were giving parenterally, however, nowadays the preferable route of
      feeding in critically ill patients is enterally. The present study was done to investigate
      the effect of enteral Omega-3 fatty acid in septic critically ill patients.
    

Detailed description: 
      A hundred and ten critically ill septic patients were included in the study. Patients were
      divided into two groups fifty-five patients each. Group A received enteral nutrition
      supplemented with Omega-3 fatty acid and group B received enteral nutrition without Omega-3.
      Demographic data, sepsis characteristics, number of patients required invasive ventilation,
      ventilation days, ICU sequential organ failure assessment score (SOFA), organ failure
      free-days, haemodynamic failure free-days, ICU stay, ICU and hospital outcomes were recorded.
    

Intervention name(s): Omega 3; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Enteral 1000 mg omega 3 fatty acid.; Enteral nutrition without omega 3 fatty acid.
Other intervention name(s): Omega 3 fatty acid; Placebo group
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Validation of Brain Function Assessment Algorithm for mTBI/Concussion in College Athletes
Condition: Brain Injuries, Traumatic; Concussion, Mild; Concussion, Brain; Concussion, Severe; Concussion, Intermediate
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Observational

Summary: 
      This study is Part 1 of data collection from 18-25 years old subject population for
      validation of previously derived algorithms. This data will be combined with that collected
      under NCT03671083 (Part 2 with subject age range 13-25 years) for the final analyses of
      validation of the algorithms.
    

Detailed description: 
      EEG, neurocognitive performance and clinical data will be collected at time of injury (within
      3 days) at clinically determined Return to Play (RTP) and 45 days after RTP, for the purpose
      of independently validating the performance of the algorithms developed in prior studies
      (NCT02477943, NCT02661633 and NCTXXXXXX). Data collected under this study will be combined
      with that collected under NCT03671083 for the final analyses of prospective algorithm
      performance in an independent population ages 13-25 years. Subjects will come from the sports
      and other populations of concussed individuals. They will be matched with controls i.e. not
      head injured subjects who will also undergo the same set of tests and the same time intervals
      as the injured subjects. An additional pool of uninjured (not head injured) subjects will be
      collected who will be assessed at a single time point.
    

Intervention name(s): BrainScope Ahead 200iD
Intervention type(s): Device
Intervention description(s): The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and Ocular Motor assessment. BrainScope Ahead 200iD device will be used to perform EEG.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 220 male and female student-athletes from participating universities or
        colleges will be invited to participate.
      
Keywords: Concussion; Mild Traumatic Brain Injury; Sport Related Concussion
IN2SHAPE: A Study of Physical Activity and Depressive Symptoms in Adolescence
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether physical activity prevents development of
      depressive symptoms in adolescents.
    

Detailed description: 
      The primary objective of the project is to establish whether increasing physical activity can
      promote mental well-being in adolescents who are already displaying some depressive symptoms.

      A further objective is to evaluate the feasibility of a novel self-motivated physical
      activity intervention, which has been designed for this project.

      The final objective of this project is to investigate alternative intervention delivery
      modes, for an adolescent sample with subclinical depressive symptomatology, i.e., presenting
      with some depression symptoms but not at a level where major depressive disorder would be
      diagnosed. We aim to compare the effect of a completely mediated delivery approach for
      physical activity (i.e., no researcher contact) and a mediated intervention with face-to-face
      contact and fortnightly check-in telephone calls.
    

Intervention name(s): Self-motivated physical activity; Nutrition; Physical activity researcher contact
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Components:
Physical activity education in the form of a brief booklet (double sided A4 page).
Physical activity motivation tips (one sided A4 page).
Pedometer
Monitoring chart
Online presentation of common obstacles and ways to overcome these obstacles; Components:
Nutrition education booklet (Double-sided A4 page)
Nutrition motivation tips (single-sided A4 page)
Nutrition monitoring chart
Online presentation of common obstacles and ways to overcome these obstacles; Behavioral: Self-motivated physical activity
Components:
Physical activity education in the form of a brief booklet (double sided A4 page).
Physical activity motivation tips (one sided A4 page).
Pedometer
Monitoring chart
Online presentation of common obstacles and ways to overcome these obstacles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Depression; Motor Activity; Adolescent