bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial Evaluating the Safety and Efficacy of Levamisole in Loa Loa Microfilaremic Patients
Condition: Onchocerciasis, Ocular; Loiasis
MeSH terms: Onchocerciasis; Onchocerciasis, Ocular
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims at evaluating the safety and efficacy of levamisole in patients with loiasis
      infection.
    

Detailed description: 
      This clinical trial will be conducted in Republic of Congo. This is a pragmatic and
      adaptative randomized, double-blind clinical trial. Levamisole will be tested at 1 and 1,5
      mg/kg, and compared to placebo (36:36:36); or 2,5 mg/kg compared to placebo (36:36) in case
      of adaptation of the dose for cohorts II and III.

      We will perform three cohorts of patients according to the microfilarial density : 1-1,999
      mf/ml, 1-14,999 mf/ml, and all microfilaremic individuals; in order to respect the safety
      potentially related to loiasis.

      The first cohort was to evaluate the most appropriate dose of levamisole, with a possibility
      to increase (to 2.5 mg/kg) the dose of levamisole for the cohorts II and III in case of lack
      of efficacy and in case of good safety profil.
    

Intervention name(s): LEV 1 mg/kg; LEV 1,5 mg/kg; LEV 2,5 mg/kg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.; A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.; A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.; 5 tablets of placebo will be administrated to the participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Wound-healing Improvement by Resurfacing Split-Thickness Skin Donor Sites With Thin Split-thickness Grafting
Condition: Skin Graft Disorder; Disorder of Skin Donor Site; Wound Healing Disturbance of
MeSH terms: Skin Diseases; Wounds and Injuries
Study type: Observational [Patient Registry]

Summary: 
      Split-thickness skin grafting remains fundamental treatment of patients with deep burns and
      other traumatic injuries. However, the split-thickness skin graft (STSG) donor site dressing
      has been controversial until now. Our study here aimed to assess patient comfort and
      wound-healing efficacy with the application of thin split-thickness grafting on STSG donor
      sites.
    

Detailed description: 
      Background：Split-thickness skin grafting remains fundamental treatment of patients with deep
      burns and other traumatic injuries. However, the split-thickness skin graft (STSG) donor site
      dressing has been controversial until now. Our study here aimed to assess patient comfort and
      wound-healing efficacy with the application of thin split-thickness grafting on STSG donor
      sites.

      Methods: 192 consecutive patients undergoing split-thickness skin grafting were included in
      the study and the participants were randomly divided into three groups: Group A was regrafted
      with thin STSG, while, Group B and Group C were covered with the occlusive hydrocellular
      dressing and paraffin gauze, respectively. The three groups were compared regarding to the
      time of epithelialization, pain sensed by the patients and the scar formation.
    

Intervention name(s): regrafted with thin split-thickness skin graft; covered with the occlusive hydrocellular dressing; covered with paraffin gauze
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Group A (the treatment group) were regrafted with thin split-thickness skin graft; group B covered with the occlusive hydrocellular dressing (Allevyn Adhesive, Smith & Nephew); Group C covered with paraffin gauze
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study cohort included 192 participants, who were randomly selected from patients who
        continuously received an STSG from January 2002 to December 2010 in Department of Burn and
        Plastic Surgery, Tangdu Hospital, Fourth Military Medical University.
      
Keywords: the split-thickness skin graft （STSG） donor site; regraft; wound healing
Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01 % and Lumigan® 0.03% Unit Dose
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective:

      The primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01%
      and Lumigan® 0.03% Unit Dose in term of safety with respect to the assessment of conjunctival
      hyperaemia in the worse eye at Day 84.

      The conjunctival hyperaemia will be scored using the MacMonnies photographic scale (0 to 5).
    


Intervention name(s): Monoprost; Lumigan 0.01%; Lumigan 0.03% Unit Dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis.; Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.; Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.
Other intervention name(s): Latanoprost 0.005%; Bimatoprost 0.1mg/ml; Bimatoprost 0.3mg/ML
Intervention MeSH terms: Bimatoprost; Latanoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
An Observational Study of the Use of Chloral Hydrate for Ophthalmic Procedures in Children
Condition: Intraocular Pressure; Anesthesia
Study type: Observational

Summary: 
      The study involves a prospective evaluation of chloral hydrate sedation for the measurement
      of intraocular pressure in children ages one month to five years of age.
    

Detailed description: 
      This study will be a prospective, non-randomized trial of children 1 month to 5 years of age
      who are determined to require a sedation procedure at the King Khaled Eye Specialist Hospital
      (KKESH). There will be two parts to the consent process. Oral consent will be administered to
      subjects who are not undergoing eye pressure evaluation. These children have chloral hydrate
      sedation for imaging or other eye evaluations. For these children, we will prospectively
      monitor the success rate of chloral hydrate sedation such that a complete ophthalmic or
      imaging evaluation could be performed and will determine the proportion of adverse events
      that occur due to sedation including vomiting, respiratory distress or depression,
      alterations in vital signs beyond reference ranges for normal sleeping children, hypoxia with
      oxygen saturation <90%, and unplanned hospital admission. No testing will be performed for
      study purposes on these individuals.

      For children undergoing sedation who will have intraocular pressure measurements for clinical
      care purposes, we will perform additional eye pressure measurements as part of the research
      protocol. Written consent will be obtained to allow us to additionally measure their
      intraocular pressure as specified below.

      After recruitment and completion of informed consent procedures by parents, subjects' medical
      and ocular history will be reviewed by a study ophthalmologist and one of two pediatricians
      overseeing sedation procedures. Patients unable to undergo intraocular pressure measurement
      due to infection or ocular surface disease and those in whom chloral hydrate sedation is
      medically contraindicated will be excluded. Age, gender, diagnosis, current medications and
      surgical history will be recorded from the clinical chart for all subjects.
    

Intervention name(s): Intraocular pressure evaluation
Intervention type(s): Other
Intervention description(s): Intraocular pressure checked with Icare rebound tonometer at 25 minutes after induction, followed by every 10 minutes until sedation was complete.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 1 month to five years requiring sedation for ophthalmic care at King Khaled
        Eye Specialist Hospital (KKESH).
Effects of Sargassum Horneri Extract on Patients With Hypersensitivity
Condition: Skin Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The investigators conduct a randomized, double-blind, placebo-controlled study to investigate
      the effects of Sargassum Horneri Extract in patients with skin hypersensitivity for 12 weeks.
    

Detailed description: 
      Previous studies have indicated that Panax Ginseng C.A. Mey Extract may have the ability to
      improve liver function. Therefore, the investigators conduct a randomized, double-blind,
      placebo-controlled study to investigate the effects of the Sargassum Horneri Extract in
      patients with skin hypersensitivity for 12 weeks; the safety of the compound are also
      evaluate. The Investigators examine SCORAD(SCORing of Atopic Dermatitis) score, PGA (Patient
      Global assessment) score, IGA (Investigator Global assessment) score, total IgE, eosinophil
      counts, ECP, IL-4, IL-31, and TARC at baseline, as well as after 6 and 12 weeks of
      intervention. One hundred adults were administered either 1,000 mg of Sargassum Horneri
      Extract or a placebo each day for 12 weeks.
    

Intervention name(s): Sargassum Horneri Extract group; Placebo group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This group takes 1,000 mg/day of Sargassum Horneri Extract for 12 weeks.; This group takes 1,000 mg/day of Placebo Extract for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Electromagnetic Therapy on Patients With Chronic Rhinosinusitis.
Condition: Magnetic Therapy; Rhinosinusitis; Headache; Fatigue
MeSH terms: Sinusitis; Fatigue; Headache
Study type: Interventional

Summary: 
      This study aimed to evaluate the efficacy of Pulsed electromagnetic field (PEMF) for Chronic
      sinusitis in a randomized, double-blind, placebo-controlled trial.
    

Detailed description: 
      Chronic sinusitis, or chronic rhinosinusitis, is an inflammatory condition defined by
      symptomatic inflammation of the paranasal sinuses lasting longer than 3 months. Common
      presenting symptoms include nasal obstruction, facial pressure or fullness, nasal discharge
      (anterior or posterior), and olfactory loss. Furthermore, chronic sinusitis is associated
      with reductions in patient quality of life, sleep quality, and daily productivity.

      A pulsed electromagnetic field (PEMF) has an anti-inflammatory, antimicrobial, and improves
      the microcirculation of the mucosal membrane of the nasal cavity. It has been suggested that
      magnetic therapy can be used in treating chronic sinusitis but there is a scarce of studies
      about its usage.
    

Intervention name(s): Pulsed electromagnetic field
Intervention type(s): Device
Intervention description(s): Participants were randomized into either the PEMF group or sham treatment group by a computer-generated random number. The participants were treated using PEMF (20 G ,7H for 10min) and sham treatment. treatment was delivered for one month.
Other intervention name(s): Sham
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Study Examining PrEP-001 in Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2 study, to examine the prophylactic efficacy, safety and tolerability of PrEP-001 in
      asthmatics who have been infected with the human rhinovirus (HRV16) after receiving two doses
      of the study drug/placebo.
    

Detailed description: 
      Screening took place up to 90 days before quarantine, where volunteers were asked to complete
      an informed consent and undergo scheduled screening assessments to determine their
      eligibility.

      Eligible volunteers were invited to test and record their respiratory symptoms and peak
      expiratory flow (PEF), medications and any adverse events in diary cards from Day -14 to Day
      -5.

      They attended Quarantine on Day -4/-3, received the study drug/placebo intra nasally on Day
      -2 and Day -1 and subsequently challenged with HRV16 on Day 0. Randomisation to receive study
      drug/placebo was 1:1.

      Volunteers remained in the quarantine unit for 8 days after inoculation.

      PEF self-testing continued from Day 9 to Day 28.

      On Day 20 (±3 days) and Day 28 (±5 days), volunteers attended follow up visits where they
      were assessed by a study physician for well-being, on-going symptoms and adverse events.
    

Intervention name(s): PrEP-001; G-004
Intervention type(s): Drug; Drug
Intervention description(s): A spray dried powder for intranasal administration formulated from an aqueous mixture of pre-gelatinized waxy maize starch and the drug substance delivered using a single dose nasal powder device.; A spray dried pre-gelatinized waxy maize starch powder (G-001) in the single dose nasal powder device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the sensitivity and specificity of the Belun Ring
      Pulse Oximetry system for screening of obstructive sleep apnea (OSA) in adults during
      standard polysomnography sleep study conditions. The primary outcome metric is the
      Apnea-Hypopnea Index (AHI).

      The goal, in its entirety, is to evaluate the performance of the Belun Ring Pulse Oximeter
      during a standard polysomnography sleep study and its ability to compare to the determined
      Apnea-Hypopnea Index (AHI) of the subjects. It is expected that the Belun Ring Pulse Oximeter
      will adequately record SpO2, pulse rate, body position and heart rate variability throughout
      the duration of the study.
    


Intervention name(s): Belun Ring Pulse Oximeter
Intervention type(s): Device
Intervention description(s): Belun Ring Pulse Oximeter allows measurement and analysis of oximetry, pulse rate, photo-plethysmography (PPG), and accelerometer signals from the proximal phalanx of index finger. Total sleep time (Ring-TST) and respiratory event index (Ring-REI) are estimated
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in
      combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).
    


Intervention name(s): Pegylated Interferon Alfa 2a; Telaprevir; Ribavirin; Placebo
Intervention type(s): Biological; Drug; Drug; Other
Intervention description(s): subcutaneous injection, 180 micrograms once per week; 375 mg tablets administered orally every 8 hours at a dose of 750 mg; 200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing ≥75 kg; Telaprevir matching placebo
Other intervention name(s): Pegasys, Peg-IFN-alfa-2a; VX-950; Copegus, RBV
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Genotype 1
Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label randomised, two-treatment, two-period, two-sequence, single-dose, crossover,
      comparative bioequivalence study.
    

Detailed description: 
      The study was an open label, randomised, two-treatment,two-period, two-sequence, single-dose,
      crossover,comparative bioequivalence study of Naproxen Sodium 550 mg tablets (containing
      naproxen 500 mg) manufactured by Dr. Reddy's Laboratories, ltd, Generics, India compared with
      ANAPROX® OS 550 mg tablets (containing naproxen 500 mg) of Roche Pharmaceuticals, Roche
      Laboratories Inc. 340 Kingsland Street, Newjersy; in healthy,adult, human subjects under
      fasting conditions with a wash out period of 10 days between two periods.
    

Intervention name(s): Naproxen sodium
Intervention type(s): Drug
Intervention description(s): Naproxen Sodium Tablets 550 mg
Other intervention name(s): Anaprox
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Naproxen; crossover
A Study to Evaluate the Safety Profile of an e-Vapour Product
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are
      otherwise known as electronic cigarettes or electronic nicotine delivery devices/systems.
      These may look like conventional cigarettes but do not contain tobacco.

      The 'vapour' produced by such devices typically consists of humectants (propylene glycol or
      glycerol), nicotine, water, and flavours.

      This trial is to evaluate the safety of an e-vapour product.
    


Intervention name(s): E-vapour product; Conventional cigarette
Intervention type(s): Other; Other
Intervention description(s): Smokers of conventional cigarettes who switch to use an e-vapour product.; Smokers of conventional cigarettes who continue smoking conventional cigarettes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Hydroxyapetite Nanoparticles, Tricalcium Phosphate Nanoparticles, and PRF for Treatment of Gingival Recession
Condition: Periodontitis
MeSH terms: Periodontitis; Gingival Recession
Study type: Interventional

Summary: 
      The aim of the present study was to compare between nanocrystalline hydroxyapatite and
      tricalcium phosphate carried on PRP membrane in treatment of Miller's class 1 gingival
      recession in human.
    

Detailed description: 
      gingival recession (GR) is apical movement of the gingival margin beyond the cement-enamel
      junction. The use of free gingival grafts, sliding pedicle grafts, subepithelial connective
      tissue grafts, envelope or tunnelling techniques, the use of acellular dermal, connective
      tissue allografts, guided tissue regeneration, Platelet rich fibrin (PRF), and coronally
      advanced flap (CAF) are the surgical methods that have been developed to treat gingival
      recession. For treatments of intrabony defects, a synthetic nanocrystalline hydroxyapatite
      (NcHA) bone graft has been introduced. Osteoconductivity, bioresorbability, and close contact
      are benefits of NcHA material. Critical size defects showed quick healing when the NcHA was
      utilised as a bone graft alternative. NcHA binds to bone and increases osteoblast activity to
      promote bone regeneration. A promising bone replacement material, tricalcium phosphate (TCP)
      is known for its strong bioactivity and resorbable qualities. Tricalcium phosphate (TCP) is
      one of the most popular and effective artificial bone substitutes. It is osteoinductive as
      well as osteoconductive. These characteristics enable full bone defects regeneration together
      with its cell-mediated resorption. In this study, we compared between nanocrystalline
      hydroxyapatite and tricalcium phosphate carried on PRP membrane in treatment of Miller's
      class 1 gingival recession in human.
    

Intervention name(s): coronally advanced flap; Nanocrystalline hydroxyapatite loaded in PRF; Nanocrystalline tricalcium phosphate loaded in PRF
Intervention type(s): Procedure; Other; Other
Intervention description(s): coronally advanced flap operation; Nanocrystalline hydroxyapatite loaded in PRF; Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment