bioihbjkbjnl/mcl2 huggingface dataset:
Environmental Intervention to Reduce Allergens in Urban Schools and Childhood Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The investigators aim to pilot the role of school based intervention consisting of enhanced
      integrated pest management, classroom air purifiers and cleaning improves asthma morbidity.
    

Detailed description: 
      By piloting this school based intervention, the investigators hope to learn from this study
      the best way to design and implement more cost and time efficient large-based school-based
      environmental interventions that may potentially help a community of children with asthma,
      allergic diseases, and its associated morbidity.
    

Intervention name(s): integrated pest management; air purifier; Sham air purifier
Intervention type(s): Other; Other; Other
Intervention description(s): integrated pest management and environmental strategy; air purifiers; sham air purifiers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Trial of Equine F (ab')2 Antivenom for Treatment of Scorpion Envenomation in Morocco
Condition: Poisoning by Scorpion Sting
MeSH terms: Poisoning; Scorpion Stings
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study has the objective to demonstrate the effectiveness of Alacramyn NAMO in the
      treatment of North Africa and Middle East scorpions envenomation by reducing the severity of
      envenomation. The primary endpoint is make a comparison between antivenom and placebo groups,
      at 4 hours after study drug, of the number of cases showing improvement in class of
      envenomation.
    

Detailed description: 
      In an effort to shorten hospital stay and to further decrease mortality, a new antivenom has
      been developed. This antivenom is a third generation F(ab')2 "fabotherapeutic" agent.It is
      administered intravenously which should lead to rapid neutralization of circulating venom.
      This study will demonstrate whether or not use of the new antivenom in children receiving
      standardized supportive care leads to resolution of the syndrome within 4 hours of
      treatment.The onset of clinical symptoms following a scorpion envenomation is usually within
      5 to 30 minutes following the sting.

      Established a classification of the patient status to differentiate a simple scorpion sting
      from a severe envenomation. A simple sting (class I) is characterized by signs that are local
      only: pain at the inoculation point, redness, edema, and numbness.

      A class II envenomation is characterized by the presence of some systemic signs: hypothermia,
      hyperthermia, chills, nausea, abdominal pain and diarrhea. Being 15 years old or younger or
      the presence of priapism, vomiting, sweating, or a body temperature greater than 39°C are
      factors predictive of severity.

      A severe envenomation (class III) is characterized by cardiovascular failure, often leading
      to death; respiratory failure related to the cardiac failure; and neurologic failure due to
      hypoxia.
    

Intervention name(s): Equine F(ab')2 antivenom; Intensive care support plus placebo
Intervention type(s): Biological; Other
Intervention description(s): A single dose of 4 vials of Equine F(ab')2 antivenom will be administered intravenously over 10 minute; Intensive care support as needed plus placebo
Other intervention name(s): Alacramyn NA; Scorpion North Africa and Middle East Immune F(ab')2(Equine)
Intervention MeSH terms: Antivenins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Effectiveness; New Antivenom; North Africa and Middle East Scorpio Envenomation
Evaluating the Clinical and Immune Response to Two Dengue Virus Vaccines in Healthy Adults
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue viruses infect millions of people throughout the tropics and subtropics each year. The
      development of a dengue vaccine is an important health priority. This study will evaluate the
      immunologic and clinical response to two dengue vaccines, given 9 months apart, in healthy
      adults with no history of previous flavivirus infection.
    

Detailed description: 
      Dengue is a mosquito-borne flavivirus. There are 4 types of dengue virus (DENV-1, DENV-2,
      DENV-3, and DENV-4), each of which can cause mild illness to life-threatening disease. The
      purpose of this study is to evaluate the immunologic and clinical response to two dengue
      vaccines (rDEN1Δ30 and rDEN2Δ30-7169), given 9 months apart, in healthy adults with no
      history of previous flavivirus infection.

      Participants will be randomly assigned to receive the rDEN1Δ30 vaccine or a placebo vaccine
      at Day 0. Additional study visits will occur at Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90,
      180, and 240. At Day 270, all participants will receive the rDEN2Δ30-7169 vaccine. An
      inpatient (overnight) stay will occur on Days 274 through 284, with participants being
      discharged on Day 284, if they meet the study criteria. Additional visits will occur at Days
      286, 291, 298, 326, 360, and 450. Study visits will include blood collection and a physical
      examination. Participants will monitor and record their temperature 3 times a day for several
      days after each vaccination.
    

Intervention name(s): rDEN1Δ30; Placebo; rDEN2Δ30-7169
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Administered subcutaneously in 0.5 mL containing 10^3.0 plaque-forming units (PFU); Administered subcutaneously in 0.5 mL; Administered subcutaneously in 0.5 mL containing 10^3.0 PFU
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Randomized Study on the Effect of Oesophageal Temperature on the Incidence of Esophageal Lesions After AF Ablation
Condition: Cardiac Arrhythmias; Atrial Fibrillation; Esophageal Ulcer
MeSH terms: Atrial Fibrillation; Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      It's a randomized pilot study to evaluate the incidence of esophageal thermal injury after
      left atrial ablation for the treatment of atrial fibrillation according to three different
      strategies of esophageal temperature monitoring.

      These patients will be divided into 3 groups with different strategies of esophageal
      temperature monitoring: group 1 without monitoring, group 2 monitoring with single probe
      thermometer and group 3 monitoring with multi-probe thermometer.

      The primary end point will be the incidence of esophageal lesions assessed by upper
      endoscopy.
    

Detailed description: 
      This is a randomized pilot study on the effect of oesophageal temperature monitoring on the
      esophageal thermal injury after left atrial ablation for the treatment of atrial fibrillation
      (AF).

      Sixty patients with paroxysmal AF or persistent and without previous AF ablation with
      indication of AF ablation will be selected to be included at the study.

      After informed consent, these patients will be randomized in 3 groups with different
      strategies of esophageal protection for radiofrequency application in the posterior wall of
      the left atrium, by randomization in a ratio of 1: 1: 1 between groups.

      Group I: no esophageal temperature monitoring technique. Group II: monitoring of esophageal
      temperature during radiofrequency applications in the posterior wall of the left atrium, with
      unipolar thermometer.

      Group III: oesophageal temperature monitoring during radiofrequency applications in the
      posterior wall of the left atrium, with a multipolar and self expandable thermometer.

      The primary end point will be the incidence of esophageal lesions assessed by upper endoscopy
      that will be done in all patients.
    

Intervention name(s): multipolar and self expandable thermometer; Single probe thermometer
Intervention type(s): Device; Device
Intervention description(s): Will be evaluated if a multipolar and self expandable thermometer is superior to no probe or to single probe thermometer at prevention of esophageal thermal injury.; Will be evaluated if a single probe thermometer is superior to a multipolar and self expandable thermometer or to no probe thermometer at prevention of esophageal thermal injury
Other intervention name(s): CIRCA's S-CATH™ Esophageal Temperature Monitoring System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: atrial-esophageal fistula; radiofrequency ablation; Atrial Fibrillation ablation
Contribution of Pancreatic αcells Function to Blood Glucose Regulation in Chinese Type 2 Diabetics- the Effect of Sitagliptin on Glucagon Secretion, Insulin Secretion and Insulin Resistance in Chinese Type 2 Diabetics
Condition: Insulin Secretion; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      1. The purpose of this study is to determine whether Sitagliptin therapy suppress glucagon
           release and improve glucose control in Chinese type 2 diabetic.

        2. There are different effects of Sitagliptin therapy on blood glucose regulation,
           pancreatic alpha & beta cell function are different in lean (BMI<25) and overweight
           (BMI>25) Chinese type 2 diabetics.

        3. The purpose of this study is to determine whether glucagon release may contribute over
           30% to the hyperglycemia in Chinese type 2 diabetics.
    


Intervention name(s): Sitagliptin
Intervention type(s): Drug
Intervention description(s): Sitagliptin 100 mg QD for 12 weeks
Intervention MeSH terms: Sitagliptin Phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glucagon; dipeptidyl peptidase-4 inhibitor
Wound Vac Bandage Comparison After Spinal Fusion
Condition: Neuromuscular Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of incisional vacuum-assisted
      closure (VAC) therapy in the prevention of infection after posterior spinal fusion for
      pediatric neuromuscular scoliosis, in comparison to a regular gauze bandage.
    

Detailed description: 
      A prospective randomized controlled study: Patients undergoing posterior spinal fusion will
      be randomized to a standard postoperative dressing versus an incisional VAC dressing. Both
      groups will have hematocrit, total lymphocyte count, and albumin checked preoperatively to
      assess nutritional status, drawn at the same time as standard preoperative labs during
      history and physical visit. Both groups will undergo standard wound closure and dressing
      application before breaking the sterile field. The incisional VAC group will undergo
      placement of an Adaptic dressing over the incision. A standard VAC sponge will be placed and
      secured with adhesive dressing, and a suction tube will be connected to a VAC machine set to
      75 mmHg of continuous suction. The incisional VAC will be left in place for 72 hours
      postoperatively. Remainder of postoperative care will follow our standard posterior spinal
      fusion protocol and will be identical in both groups. Patients will be followed for a minimum
      of 2 years postoperatively.
    

Intervention name(s): Incisional Wound Vac; Standard Bandage
Intervention type(s): Device; Other
Other intervention name(s): Incisional vacuum-assisted closure therapy; Gauze Bandage; Gauze
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wound Vac; Neuromuscular Scoliosis; Posterior Spinal Fusion
Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to
      Humalog® in Subjects with Type 1 Diabetes
    

Detailed description: 
      The purpose of this study is to assess the speed of absorption of BIOD-238 and BIOD-250
      compared to Humalog®. Secondary objectives are to assess other pharmacokinetic
      characteristics of BIOD-238 and BIOD-250 compared to Humalog®, and to evaluate the safety and
      tolerability of BIOD-238 and BIOD-250 compared to Humalog®.
    

Intervention name(s): Insulin LISPRO; Insulin LISPRO; Insulin LISPRO
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes
Safety Evaluation of Aminophylline and Methazolamide
Condition: Mountain Sickness
MeSH terms: Altitude Sickness
Study type: Interventional
Phase: Phase 1

Summary: 
      This safety study is the first in a series of studies testing the application of the
      combination of aminophylline and methazolamide.
    

Detailed description: 
      After successful completion of this safety trial, our goal will be to evaluate the safety of
      this combination in healthy individuals exposed to hypoxia and exercise. Subsequently, an
      efficacy study will clarify whether this drug combination improves physical and mental
      functions in human subjects under high altitude conditions.
    

Intervention name(s): Aminophylline; Methazolamide; Aminophylline and Methazolamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Aminophylline dosage form-tablet dosage-500mg; Methazolamide dosage form-tablet dosage-250mg; Aminophylline 500mg orally and Methazolamide 250mg orally
Other intervention name(s): theophylline; Neptazane; theophylline; Neptazane
Intervention MeSH terms: Aminophylline; Methazolamide; Theophylline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Altitude Sickness; High Altitude Sickness
Vigilance and Simulated Driving After a Nap
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The objective of this study is to assess the effectiveness of naps under different
      environmental conditions and a rest without nap, on driving, alertness and psychomotor
      performance.

      This study also aims to record during nap time, sleep, body temperature and heart rate.
    

Detailed description: 
      Nap time is one of the most effective means of combating decreased alertness throughout the
      day and maintaining cognitive and psychomotor performance.

      As such, it is recommended for long-haul drivers driving their vehicle. However, these
      drivers have no alternative but to sleep in their seats. These conditions are not optimal for
      producing quality sleep. The motorcyclist, for his part, has no chance of sleeping without
      finding a place to feel safe to give himself up to sleep. On these bases, SOMBOX has
      developed a mini-hotel allowing drivers to find an optimized place to take a nap.

      Investigators propose an experimental study to evaluate the effectiveness, on simulator
      driving performance and on the results obtained during cognitive and motor testing, of a nap
      taken under three different conditions. The effect of the nap will be assessed by comparison
      to a rest awake.

      This study should include healthy volunteer participants.
    

Intervention name(s): Nap
Intervention type(s): Behavioral
Intervention description(s): Each participant is compared to himself in 4 conditions,
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Participant is evaluated in 4 situations :
nap in a bed
nap on a car sit
nap in the Sombox
no nap sitting on a car sit
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Nap; vigilance; cognition; driving simulation
Study of AERAS-402 in Healthy Infants
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      AERAS-402 will be given to infants of at least 16 weeks of age who have already been
      vaccinated with BCG to determine if AERAS-402 will increase protection of infants to
      tuberculosis.
    

Detailed description: 
      The only currently available tuberculosis vaccine, bacillus Calmette-Guérin (BCG), is
      estimated to reduce the risk of tuberculosis (TB) in children by up to 70-80%, but protection
      is incomplete. Efforts to increase TB protection in children include new vaccines for primary
      immunizations as well as combinations of vaccines given as primary and boosting vaccinations.

      AERAS 402 is a live recombinant serotype 35 replication deficient adenovirus vector
      expressing a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens (Ag85A, Ag85B
      and TB10.4). It presents Mtb antigens in the setting of a new, live, replication-deficient
      adenovirus vaccine that may increase T cell-mediated immunity and thus protection from
      tuberculosis. AERAS-402 appears safe and immunogenic in adults. Since BCG-vaccinated infants
      are the population for which AERAS-402 might be indicated, AERAS-402 will be administered to
      infants of at least 16 weeks of age who have already been vaccinated with BCG. This is the
      first Phase II study of AERAS-402 in infants.
    

Intervention name(s): AERAS-402 1.5 x 10^10 vp; AERAS-402 3.0 x 10^10 vp; AERAS-402 1.0 x 10^11 vp; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tuberculosis; Vaccine; Immunogenicity; Prevention of Tuberculosis
A Phase 1 Dose Escalation Study of Oral VX-708 in Healthy Participants
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of single and multiple ascending doses of VX-708 in healthy participants.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): VX-708; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution or suspension for oral administration.; Placebo matched to VX-708 for oral administration.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Assess the Rate and Extent of Absorption of Hydrocodone From 20 mg Hydrocodone Bitartrate Extended-Release Capsules
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      -  Assess the rate and extent of absorption of hydrocodone from a 20 mg HC-ER capsule in
           both fed and fasted states

        -  Evaluate the safety and tolerability of the test compound administered orally
    

Detailed description: 
      Safety parameters assessed included medical history, physical examination, vital signs,
      12-lead ECGs, clinical laboratory testing and adverse event assessment.
    

Intervention name(s): HC-ER 20 mg capsule (fasted); HC-ER 20 mg capsule (fed)
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose HC-ER 20 mg capsule after overnight fast (fasted); Single oral dose HC-ER 20 mg capsule after high fat meal (fed)
Other intervention name(s): Zohydro ER; Zohydro ER
Intervention MeSH terms: Hydrocodone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Food Effect; Pharmacokinetics
eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer
Condition: Infertility; Pregnancy, Multiple
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a policy of elective single embryo transfer
      (eSET) plus single embryo cryotransfer is as effective as a double embryo transfer in terms
      of clinical pregnancy rate
    

Detailed description: 
      The objective is to evaluate the In Vitro Fertilization/Intracytoplasmic Sperm Inyection
      (IVF/ICSI) results in terms of clinical pregnancy and multiple pregnancy rates, comparing
      elective single embryo transfer plus cryotransfer of one embryo if pregnancy is not achieved,
      with double embryo transfer.

      This is a prospective randomized study, including couples arriving to the Reproductive Unit
      of the Hospital Universitario Virgen de las Nieves. All these patients had good reproductive
      prognosis and had been asigned randomly to one of the following groups: Group 1: elective
      single embryo transfer. In the case pregnancy is not achieved a cryotransfer of one embryo
      will be carried out. Group 2: elective double embryo transfer.
    

Intervention name(s): Elective single embryo transfer; Double embryo transfer
Intervention type(s): Procedure; Procedure
Intervention description(s): After the FIV/ICSI procedure, the embryo transfer in this arm would be of one embryo followed by the cryotransfer of one embryo in case of no conception in the fresh cycle.; After the FIV/ICSI procedure, the embryo transfer in this arm would be of two fresh embryos
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care