bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Yellow Fever Inactivated Vaccine
Condition: Yellow Fever
MeSH terms: Yellow Fever; Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      The Phase 1 trial is a single-center, randomized, double blind, placebo-controlled,
      dose-ranging out-patient study designed to provide the first clinical data on the safety,
      tolerability and immunogenicity of XRX-001 inactivated yellow fever vaccine in 60 healthy
      male and female volunteers, 18-49 years of age. Subjects will receive two inoculations of one
      of two dose levels of XRX-001 vaccine. A control group will receive placebo.

      Safety will be determined by the incidence and severity of adverse events in each treatment
      group and in the combined cohorts in the double blind treatment period up to 42 days
      post-vaccination. Subjects will also be followed-up at 3, 6 and 12 months to determine severe
      adverse events (SAEs) and changes in health status.

      Efficacy will be assessed by neutralizing antibody response to the vaccine. The co-primary
      immunogenicity endpoints will be the dose-response analysis of seroconversion rates (fourfold
      or greater increase in neutralizing antibody titer between baseline and Day 42) and of the
      50% plaque reduction neutralization test (PRNT50) geometric mean titers (GMT) at Day 42.

      Secondary immunogenicity endpoints will include:

        1. The seroconversion rates and GMT neutralizing antibody titers for all dose groups
           combined on Days 21 and 42.

        2. The reverse cumulative distribution curve of antibody titers on Days 21 and 42 for each
           dose group and for all dose groups combined

        3. The duration of antibody titers displaying the seroconversion rate and GMT across all
           time-points to Month 12, by treatment group and for both dose groups combined.
    


Intervention name(s): XRX-001 Inactivated yellow fever vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL; NaCl Injectable 0.9%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention of yellow fever virus infection
Comparing Triamcinolone Acetonide Mucoadhesive Films With Licorice Mucoadhesive Films
Condition: Mucositis
MeSH terms: Mucositis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Abstract:

      Background: Complementary and alternative medicine (CAM) had proven efficacy in pain relief,
      correction of nutritional status and improving the performance status. However, lack of
      standardization is the major obstacle for any scientific evaluation of any CAM trial.
      Mucositis is a major complication of irradiation in head and neck (H&N) tumors, the addition
      of chemotherapy to irradiation may enhance this dose limiting problem. Licorice is a strong
      demulcent that had been effectively used in treatment of peptic ulcer. The main purpose of
      this study was to compare the therapeutic safety and efficacy of T. and L. mucoadhesive films
      on oral mucositis in terms of pain control and/or ulcer treatment.

      Methods and Materials: the study was a double-blind, randomized prospective trial of two
      types of mucoadhesive films in the management of oral mucositis occurred during head and neck
      cancer ( HNC ) radiotherapy. oral mucositis was assessed using a quantitative scale (WHO
      scales) and symptoms were assessed using visual analogue scales (VAS). 60 patients were
      enrolled in the study; there were 30 patients in the Triamcinolone (T) and 30 in the Licorice
      (L) group. In the T- group, patients received triamcinolone acetonide mucoadhesive films
      containing 1mg of the drug and patients in the L- group received licorice mucoadhesive films,
      an herbal agent. Data were collected at baseline, then twice a week for 4 weeks.
    


Intervention name(s): Triamcinolone Acetonide; licorice mucoadhesive films
Intervention type(s): Drug; Drug
Intervention description(s): 30 patients received licorice mucoadhesive films
Other intervention name(s): made in Germany (Merck); AFTOGEL Patch
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: irradiation; mucositis; triamcinolone acetonide; licorice; mucoadhesive film
Second Trimester Maternal Serum Homocysteine Levels and Uterine Artery Doppler for Prediction of Preeclampsia and Placentation Disorders
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      The current study included the singleton pregnancies (without history of previous risk
      factors), had their homocysteine measured as part of a serum-screening program in addition to
      uterine artery Doppler. Sensitivity, specificity, positive and negative predictive values,
      for development of preeclampsia and other adverse pregnancy outcomes were assessed as
      follows; (1) Homocysteine cutoff level at 6.3 µmol/l; (2) Bilateral notches on Doppler with a
      mean RI >0.5, all unilateral notches with a mean RI >0.6, in addition, absence of notches
      with a mean RI >0.7; (3) Doppler assessment combined with the homocysteine cutoff (6.3
      µmol/l).
    

Detailed description: 
      These participants had uterine artery Doppler investigations, as part of a routine scan
      between the 18th and the 22nd week of pregnancy. The investigators were blinded to the
      results of the biochemistry results.

      All samples of the tHcy measurement were collected between 15 and 19 weeks of gestational
      age, as calculated from the last menstrual period or from early ultrasound dates (when the
      menstrual dates differed from the specified gestation). The plasma tHcy concentrations were
      measured by means of a fluorescence polarization immunoassay (9).

      Uterine artery flow velocity waveforms were obtained using an SD 800 Doppler system (Philips
      Medical Systems, Gland, Switzerland) with a 3.5/5-MHz linear array probe. The high-pass
      filter was set at 100 Hz. One operator performed the measurements. The use of mean resistance
      index (RI) cutoff points with bilateral and unilateral notches has already been shown to
      improve the efficacy of uterine artery Doppler screening using qualitative assessment (10). A
      screen-positive or abnormal result was defined as bilateral notches and a mean RI >0.55 (50th
      centile), unilateral notches and a mean RI >0.65 (80th centile), and absence of notches and a
      mean RI >0.7 (95th centile) (11). Women with these abnormal results were offered growth
      scans, amniotic fluid volume assessment, and umbilical artery Doppler every 4 weeks until 36
      weeks in view of the recognized increased risk of isolated IUGR (12), unless there were other
      clinical indications, which necessitated closer surveillance
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Spontaneous pregnancies without history of risk factors for preeclampsia were enrolled in
        the current study
      
Biospecimen description: 
      The plasma tHcy concentrations were measured by means of a fluorescence polarization
      immunoassay
    
Keywords: Homocysteine; Preeclampsia; poor placentation
Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005)
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare plasma and urine PK parameters of MK-3866 between
      participants with impaired renal function and healthy control participants, to investigate
      the extent to which MK-3866 is removed from the plasma by hemodialysis (HD), and evaluate the
      safety and tolerability of MK-3866 in participants with impaired renal function.
    

Detailed description: 
      This is an open-label, 2-part single dose study: Part 1 will include participants with mild,
      moderate, and severe renal impairment (as well as healthy control participants), and Part 2
      will include participants with end stage renal disease (ESRD) undergoing HD. Participants in
      Part 1 will receive a single IV dose of MK-3866, and plasma and urine samples will be
      collected over pre-specified time intervals. Participants in Part 2 will receive a single IV
      dose of MK-3866 on two separate occasions: in Period 1 immediately following their
      normally-scheduled HD, and in Period 2 approximately 30 minutes prior to their
      normally-scheduled HD. Plasma, urine, and dialysate samples will be collected over
      pre-specified time intervals for Part 2.
    

Intervention name(s): MK-3866
Intervention type(s): Drug
Intervention description(s): Single IV infusion of 200 mg administered over 30 minutes (±5 minutes) on Day 1 of each treatment period.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Naltrexone Versus Placebo to Reduce Craving for Alcohol With Evaluation of Genetic Variability.
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether naltrexone (an opiate blocking agent
      approved for the treatment of alcohol dependence) is more effective in the reduction of
      alcohol craving and drinking compared to placebo in individuals with particular genetic
      predisposition.
    

Detailed description: 
      About 300 non-treatment seeking alcoholics will be recruited through advertisement and paid
      for their participation. They will be assessed, subtyped for mu-opiate receptor and
      catechol-O-methyltransferase (COMT) allelic variants and 88 individuals (44 with the more
      common AA gene and 44 with either an AG or GG gene) will be randomly assigned to take either
      naltrexone (50 mg/day) or a matching placebo for 7 days. Since the val and met alleles of the
      catechol-O-methyltransferase (COMT) gene are each present in about 50% of the population they
      will be equally distributed by urn randomization to all opiate allele and treatment groups.
      After 5 days of natural drinking and one day of abstinence, subjects will undergo an alcohol
      cue-induced brain activity scan using well-established fMRI techniques on Day 6 of study
      drug. The following day all subjects will receive a standard dose (gender and weight
      corrected) of alcohol and be evaluated for alcohol reactivity (stimulation, sedation,
      intoxication, craving) over 40 minutes. They then will be allowed to consume up to 8
      mini-drinks over a 2-hour period. Afterwards all subjects will receive
      educational/motivational counseling regarding their alcohol use and its effects. Referral for
      treatment will be offered.
    

Intervention name(s): Naltrexone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Naltrexone (25 mg/day for days 1-2 and 50 mg/day for days 3-7); Placebo for 7 days matched to Naltrexone
Other intervention name(s): ReVia
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol dependence; Alcoholism; Craving; Genetic
Fenzian Asthma Multicenter Outcomes Study
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of Fenzian™ treatment on symptoms
      (such as shortness of breath), lung function (how well the lungs work), and
      albuterol/salbutamol (rescue medication) use in people with asthma. This will be done by
      comparing the effects of Fenzian™ treatment to the effects of a sham treatment, which looks
      the same as the Fenzian™ device but doesn't do anything.

      The Fenzian™ device is an electrical instrument that the investigators hope will help reduce
      airway inflammation associated with asthma symptoms by stimulating the nerves with very low
      electrical currents. The study device will be applied directly to the skin on the back,
      working along the ribs toward the spine, alternating between left and right sides, and on
      your face.
    


Intervention name(s): Fenzian Device; Sham Device
Intervention type(s): Device; Device
Intervention description(s): Three 20-minute treatments with the Fenzian Device per week for 5 weeks (for a total of 15 treatments); Three 20-minute treatments with the sham device per week for 5 weeks (for a total of 15 treatments) (NOTE: This arm is similar to a placebo arm in a drug trial.)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Lung Diseases; Respiratory Tract Diseases
Assessment of a Pre-Workout Dietary Supplement
Condition: Dietary Modification
Study type: Interventional

Summary: 
      The purpose of this study is to examine the acute effects of a pre-workout dietary supplement
      on energy metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.
    

Detailed description: 
      A number of nutritional strategies have been developed to optimize nutrient delivery prior to
      exercise. This includes providing carbohydrate and a number of ergogenic nutrients prior to,
      during and/or following exercise. As a result a number of pre-workout supplements have been
      developed to increase energy availability, promote vasodilation and/or positively affect
      exercise capacity. The purpose of this study is to investigate the potential ergogenic value
      of acute ingestion of a pre-workout dietary supplement prior to exercise.
    

Intervention name(s): C4 Extreme; C4 Extreme (without Advantra Z; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Pre-Workout Dietary Supplement; Pre-Workout Dietary Supplement; Pre-Workout Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Clinical Study to Test the Effects of a Low-Carbohydrate Diet on Body Weight
Condition: Obesity
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of a modified carbohydrate diet versus a
      portion controlled diet in overweight or obese men and women on body weight.
    


Intervention name(s): Low carbohydrate diet (behavior)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability and Efficacy of Oral Administration of PTL101 (Cannabidiol) as an Adjunctive Treatment for Pediatric Intractable Epilepsy
Condition: Epilepsy Intractable
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety, tolerability and efficacy of oral administration of PTL101
      (cannabidiol) for the treatment for pediatric intractable epilepsy.

      Study will include a 4-week observation period ,12 weeks of treatment and 2 weeks of follow
      up.
    

Detailed description: 
      This is an open-label, single-center study recruiting approximately 15 male or female
      pediatric (ages 2-15, inclusive) patients with, intractable epilepsy, on stable doses of
      antiepileptic drugs (AEDs). The study comprised of the following period: 4 weeks observation
      period, followed by a 2-week dose titration period, 10-week maintenance treatment period, and
      a 2-week follow-up of which 1 week is a tapering-off period. Seizures will be recorded by the
      legal guardian/caregiver in seizure diaries throughout the first 16 weeks of the study.
    

Intervention name(s): PLT101
Intervention type(s): Drug
Intervention description(s): PTL 101 (Cannabidiol, CBD) Two piece hard capsules filled with seamless gelatin matrix green beads containing CBD (50 or 100 mg CBD per capsule) The beads should be administered following a meal, mixed with food
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of
      Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate
      Response to Disease-Modifying Anti-rheumatic Drug(s).
    


Intervention name(s): SAN-300 0.5 mg/kg QW; SAN-300 1.0 mg/kg QW; SAN-300 2.0 mg/kg QOW; SAN-300 4.0 mg/kg QOW; SAN-300 4.0 mg/kg QW; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 2a multiple ascending dose, Anti-Very Late Antigen-1
Research for Specific Proteins of Interest for the Serological Diagnosis of Bird Fancier's Lung
Condition: Avian Hypersensitivity Pneumonitis
MeSH terms: Pneumonia; Alveolitis, Extrinsic Allergic; Bird Fancier's Lung; Hypersensitivity
Study type: Interventional

Summary: 
      This study aims at identifying bird proteins useful for diagnostic tests to determine the
      cause of Bird Fancier's Lung (BFL).
    

Detailed description: 
      Allergic diseases are an important part of health concerns in Europe and in countries
      "industrialized". Among them are distinguished from hypersensitivity pneumonitis (HP),
      consecutive to repeated inhalation of organic substances (bacteria, fungi, avian proteins
      ...).

      As with other HP, the BFL is a invalidating disease, but usually not lethal if the patient
      reduced sufficiently early exposure to antigens.

      Associated symptoms include breathing difficulties a dry cough, a general fatigued state
      accompanied by a fever and a rapid and pronounced weight loss.

      These clinical signs may be similar to a flu-like condition, difficult to discern from other
      respiratory disease. Diagnosis is based on a set of clinical, radiological and biological
      arguments that are often discussed.

      Using these criteria as predictors would increase opportunities to diagnose HP without using
      invasive clinical examinations such as biopsy and bronchoalveolar lavage.

      Although serology is a useful argument for the diagnosis, its value is often criticized.

      Thus, significant variations in performance of serological tests are observed from one
      provider to another and, for the same supplier, from one batch to another.

      This issue could be raised by the use of recombinant antigens. The principle is to use only
      to the reaction the purified protein of interest produced by genetic engineering.

      The Parasitology-Mycology department has acquired expertise in the research of proteins of
      interest for serology allergic diseases and in the manufacture of recombinant antigens. Thus
      the work of the team have identified proteins of interest for the diagnosis of two HP of
      occupational origin and translates this expertise to identify pigeon's proteins and study the
      feasibility of this research.

      For this project, the pigeon droppings (Columba livia), collected from different breeders in
      the region were identified as antigenic source.

      The objective of the HYPERSENS project is to extend the problematic to other species of birds
      and understand the specific species of antigenic proteins. The aim is also to identify and
      produce recombinant proteins that will identify the cause of avian hypersensitivity
      pneumonitis.
    

Intervention name(s): additional blood sample; respiratory functional exploration
Intervention type(s): Other; Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Lifestyle Enhancement for ADHD Program 2
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to increase physical activity (PA) in children with ADHD using a
      novel, family-based intervention that promotes PA within the context of evidence-based
      behavioral management training (BMT) for caregivers, enhanced with mobile health (mHealth)
      behavior change strategies.

      Primary Objective: To evaluate the primary effects of a 9-week, family-based intervention
      (Lifestyle Enhancement for ADHD Program - LEAP) to promote PA in young children with ADHD

      Secondary: To evaluate secondary effects of the LEAP program on child ADHD symptoms and
      executive functioning
    

Detailed description: 
      This is a randomized trial comparing the LEAP program to standard BMT for ADHD (without the
      enhanced focus on health behaviors, mHealth technology, or social media). Specifically, 80
      families will be randomized to receive either LEAP or a standard BMT program based on Russell
      Barkley's Defiant Children intervention manual. Moderators (e.g., child sex, medication, BMI)
      and mediators (e.g., change in PA) will be analyzed as exploratory outcomes. Hypotheses being
      tested include: 1) LEAP will be successful in increasing PA in children with ADHD in the
      short-term and over a year, more so than standard BPT and 2) children randomized to LEAP will
      exhibit greater and more sustained improvement in clinical outcomes relative to standard BMT.
      If successful, the R33 phase will inform the development of a larger and longer, confirmatory
      trial.
    

Intervention name(s): LEAP; Standard BMT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): LEAP will be delivered through the typical 9 weekly BMT group sessions lasting 90 minutes. Plus wrist worn activity tracker & facebook group.; Weekly BMT groups sessions which follow the Barkley curriculum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment