bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Effect of SCH 900538 on Congestion in Subjects With Seasonal Allergic Rhinitis (Study P05031)(COMPLETED)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate the effectiveness of a new drug on congestion in subjects with
      seasonal allergic rhinitis. This effect will be compared to placebo and to the decongestant,
      pseudoephedrine.
    


Intervention name(s): SCH 900538; Pseudoephedrine; Placebo Capsules
Intervention type(s): Drug; Drug; Drug
Intervention description(s): (4X50mg Capsules); Encapsulated pseudoephedrine (2X30 mg immediate release tablets); Placebo
Other intervention name(s): Sudafed
Intervention MeSH terms: Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Reducing the Acute Care Burden of Childhood Asthma on Health Services in British Columbia
Condition: Upper Respiratory Tract Infection; Asthma
MeSH terms: Respiratory Tract Infections; Asthma; Caregiver Burden
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the benefits of giving filled prescription of a
      medication to be used upon early onset of symptoms of URTI induced asthma. The hope is to
      reduce the need to present to Health Care centres for treatment.
    

Detailed description: 
      In Canada, asthma affects more the 12% of children. Exacerbation are a common feature of
      asthma. In children, upper respiratory tract infection (URTI's) are responsible for over 80%
      of asthma exacerbation.

      Experts in asthma care acknowledge this critical problem and have developed guidelines to
      reduce asthma exacerbation.

      The criteria for participation in this study to have 2 or more presentations to a Health
      Service centre in the past 12 months for URTI induced asthma. These patients will be followed
      and interviewed monthly over a 12 month period to investigate whether the use of Oral
      cortico-steroids upon early onset of URTI induced asthma prevents the need for presentation
      to hospital
    

Intervention name(s): Arm 1 Oral Cortico Steroids
Intervention type(s): Drug
Intervention description(s): Prednisolone: 1 mg / kg per day course of dose for 5 days up to child's weight of 20 kgs.
Dexamethasone: 0.3mg/kg per dose for 3 days (minimum weight 20 kgs )
Other intervention name(s): Prednisone
Intervention MeSH terms: Prednisone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Upper Respiratory Tract Infection; Asthma; URTI induced exacerbation of Asthma
Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement
Condition: Sleep Deprivation; Sleep Hygiene
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      Currently, the investigators know that there is a high and increasing prevalence of sleep
      quality and quantity deficits in the general population with the social and health
      consequences that this entails. There are numerous activity wristbands linked to mobile apps
      that analyze sleep, but none can generate individualized recommendations for improvement
      interacting with the person. The main objective of the current project is to develop a
      virtual and interactive sleep assistant to increase the quantity and quality of sleep.
      Secondary objectives being the improvement of daytime sleepiness and the quality of life of
      the persons.

      Methodology: 202 participants in active employment who meet the criteria of "poor sleepers"
      (defined by a Pittsburg test score >5) are divided into 2 study groups. 1. Intervention
      group: Sleep data will be collected using validated questionnaires (SATED and the Sleep
      Hygiene Index) and objectively employing an activity bracelet, in which weekly, through a
      live chat, the medical staff of the sleep units will offer recommendations for the
      improvement of the deficits detected. 2. Control group: Same protocol as the intervention
      group, but the participants will not receive the recommendations via the interactive chat.
    


Intervention name(s): Live Chat
Intervention type(s): Device
Intervention description(s): Subjects from the intervention group will be able to ask for a medical intervention if needed with the phisycians from the sleep unit. After the following period, we expect to see better sleep habits in this group when compared to the no intervention one
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Sustained Attention in Lowlanders
Condition: Effect of High Altitude
MeSH terms: Altitude Sickness
Study type: Interventional

Summary: 
      Prospective interventional trial in lowlanders evaluating the effect of acute exposure,
      acclimatization and re-exposure to high altitude on global cognitive function.
    

Detailed description: 
      Baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3
      days. Participants will then travel by commercial airline (2 h flight) and by bus (2 h ride)
      to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile.
      Participants will stay there for the next 7 nights and they will be spend the days (6 total;
      6-8 h daily) at the telescope station at 5050 m while undergoing testing as described above
      at the first and the last day at 5050m. Daily transports from 2900 to 5050 m will be by car
      (1 h ride, one way). After the first 7 day altitude sojourn participants will return to the
      Santiago area (520 m) for a 7 day recovery period. A second altitude sojourn with an
      identical schedule as the one described above and a final low altitude stay of 3 days will
      follow.
    

Intervention name(s): Altitude exposure
Intervention type(s): Other
Intervention description(s): Acute high altitude exposure followed by 8 day acclimatization and re-exposure for 8 days after 6 days at low altitude
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: High Altitude; Attention; Cognitive Function; Acclimatization; Sleep
Photobiomodulation and Root Resorption
Condition: Orthodontic Pathological Resorption of External Root; Orthodontic Appliance Complication; Orthodontic Tooth Movement
MeSH terms: Root Resorption; Tooth Resorption
Study type: Interventional

Summary: 
      Objectives: The aim of this study is to investigate the effect of photobiomodulation
      therapies on root resorption compared with the placebo group. Materials and Methods: 30
      patients, who were admitted to the …………. University Faculty of Dentistry Orthodontics
      Department for treatment, with an indication of upper right 1st premolar tooth extraction was
      included. Before the individuals' orthodontic treatment, 0.022 slot MBT brackets and tubes
      were placed on the maxillary 1st premolar and molar. A 150g buccal tipping force was applied
      to the 1st premolar. Individuals were then randomly divided into 3 groups. For the first
      group; laser application was performed with a 810 nm GaAlAs laser device at 0,3,7,14,21 and
      28 days to 8 J/cm2. Second group; an LED application according to the manufacturer's
      instructions with a 850 nm wavelength and 20 mW/cm2 output power for 10 minutes per day
      during the experiment. Third group; a placebo therapy was completed whereby a laser device
      that did not make active pulses was used. At the end of four weeks, the amount of root
      surface resorption was compared using micro-CT imaging after the extraction of the teeth.
    


Intervention name(s): Laser; light-emitting diode (LED); Placebo
Intervention type(s): Device; Device; Device
Intervention description(s): Diode laser device was used for photobiomodulation; LED device was used for photobiomodulation; Diode laser device was used for placebo effect
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: photobiomodulation; laser; LED; resorption; micro-CT
Study of Two Formulations of GSK Biologicals' Varicella Vaccine
Condition: Varicella
MeSH terms: Chickenpox; Herpes Zoster
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate a modified formulation of GSK Biologicals' live
      attenuated varicella vaccine. In vivo pre-clinical data show this change has no negative
      impact on vaccine safety. This present study is undertaken to rule out any negative impact on
      the immunogenicity and safety of GSK Biologicals' live attenuated varicella virus vaccine.
    


Intervention name(s): Varilrix (inactivated varicella vaccine)
Intervention type(s): Biological
Intervention description(s): subcutaneously injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: chickenpox; varicella; two-dose schedule; second year of life
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oseltamivir and Its Carboxylate Metabolite, RO0640802 in Healthy Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This multi-center, randomized, double-blind, multiple-dose, placebo-controlled,
      parallel-group study will assess the safety and PK of oseltamivir (Tamiflu) and its
      carboxylate metabolite, RO0640802 in healthy participants. Participants will be randomized to
      receive 100 milligrams (mg) oseltamivir, 200 mg oseltamivir, or placebo, all administered
      intravenously twice daily (BID). The anticipated time on study treatment is 5 days.
    


Intervention name(s): Oseltamivir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oseltamivir will be administered at 100 or 200 mg intravenous BID for 5 days.; Oseltamivir matched placebo will be administered intravenous for 5 days.
Other intervention name(s): Tamiflu, RO0640796
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Pilot Study of AuroLase(tm) Therapy in Refractory and/or Recurrent Tumors of the Head and Neck
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Recurrence
Study type: Interventional

Summary: 
      This is an open-label, multicenter, single-dose pilot study of AuroLase(TM) Therapy in the
      treatment of patients with refractory and/or recurrent tumors of the head and neck. Three (3)
      treatment groups of five (5) patients each will be enrolled and observed for six (6) months
      following treatment. Each group will receive a single dose of AuroShell(TM) particles
      followed by one or more interstitial illuminations with an 808nm laser. Particle dose and
      laser power may be increased in each dosing group.
    


Intervention name(s): AuroLase Therapy
Intervention type(s): Device
Intervention description(s): Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cancer; head and neck; laser; ablation
A Safety, Tolerability, and Efficacy Study of Intracerebroventricular BMN 190 in Pediatric Patients < 18 Years of Age With CLN2 Disease
Condition: Jansky-Bielschowsky Disease; Batten Disease; Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2; CLN2 Disease; CLN2 Disorder
MeSH terms: Neuronal Ceroid-Lipofuscinoses
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 open-label, multicenter study will evaluate the safety, tolerability, and
      efficacy of BMN 190 intracerebroventricular (ICV) administration every other week (qow) for a
      period of 144 weeks, in patients with CLN2. The study is designed to assess disease
      progression in CLN2 patients treated with BMN 190 compared to natural history data from
      untreated historical controls.
    

Detailed description: 
      BMN 190 is a recombinant form of human tripeptidyl peptidase 1 (TPP1), the enzyme deficient
      in patients with CLN2 diseases (also known as classical late-infantile CLN2, cLINCL, or
      Jansky-Bielschowsky disease), a form of Batten Disease. As an enzyme replacement therapy
      (ERT), BMN 190 is designed to help restore TPP1 enzyme activity. BMN 190 is designed to
      reduce the progressive, pathologic accumulation of lysosomal storage material. 190-203 is a
      Phase 2 open-label, multicenter study that will evaluate the safety, tolerability, and
      efficacy of BMN 190 in pediatric patients < 18 years of age with CLN2 disease. Study drug
      dosing will be determined by the patient's age and administered via intracerebroventricular
      (ICV) infusion every other week (qow), for a duration of 144 weeks.
    

Intervention name(s): BMN190 recombinant human tripeptidyl peptidase-1 (rhTPP1); Intraventricular access device
Intervention type(s): Biological; Device
Intervention description(s): Surgical implantation of an MRI compatible ICV access device in the lateral ventricle of the right hemisphere is required for administration of study drug.
Other intervention name(s): recombinant human tripeptidyl peptidase-1 (rhTPP1); cerliponase alfa; Brineura®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to asses the bioequivalence study of Fluoxetine Hydrochloride
      Delayed-Release Capsules, 90 mg and Prozac ® weekly under fasting conditions.
    

Detailed description: 
      A randomized, open label, two treatment, two period, two sequence, single dose, crossover
      bioequivalence study of Fluoxetine Hydrochloride delayed release capsules 90 mg of Dr.
      Reddy's laboratories limited, Generics, India and Prozac®weekly 90 mg delayed release
      capsules of Eli Lilly and company, USA in healthy adult human subjects under fasting
      conditions.
    

Intervention name(s): Fluoxetine Hydrochloride
Intervention type(s): Drug
Intervention description(s): Fluoxetine Hydrocloride Delayed Release Capsules, 90 mg of Dr. Reddy's Laboratories.
Other intervention name(s): Prozac ® weekly 90 mg Delayed-Release Capsules
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Fluoxetine Hydrochloride
A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is a single-center, single-dose, double-blind, parallel-group, randomized, 3-arm
      PK trial in healthy male volunteers comparing a biosimilar pertuzumab (EG1206A) to a single
      intravenous (i.v.) infusion to both European Union (EU) and United States of America (US)
      reference products.
    

Detailed description: 
      This trial is part of a clinical development program developing a biosimilar pertuzumab,
      comparing the PK, safety and tolerability and immunogenicity of pertuzumab after a single
      intravenous (i.v.) infusion.

      It assess the bioequivalence, PK characteristics, safety and tolerability as well as the
      immunogenicity of a test preparation containing 420 mg pertuzumab (EG1206A EirGenix
      Pertuzumab) as compared to marketed reference (EU and US) after a single dose i.v. infusion
      over 60 minutes in fasted state.
    

Intervention name(s): 420 mg EG1206A EirGenix Pertuzumab in 14 mL Injection; Perjeta (EU origin) 420 mg in 14 mL Injection; Perjeta (US origin) 420 mg in 14 mL Injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Healthy volunteers receive pertuzumab (EG1206A, 420 mg, single dose); Healthy volunteers receive pertuzumab (Perjeta (EU origin) 420 mg, single dose); Healthy volunteers receive pertuzumab (Perjeta (US origin), 420 mg, single dose)
Other intervention name(s): Pertuzumab; Pertuzumab; Pertuzumab
Intervention MeSH terms: Pertuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Trial of EirGenix' Pertuzumab and Perjeta® (Pertuzumab) sourced from US and EU Administered to Healthy Male Volunteers
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HER2 positive; early stage breast cancer; metastatic breast cancer; combination therapy; inhibiting MAP Kinase; P13K/Akt
Simplified Versus Conventional Complete Dentures
Condition: Complete Edentulism
Study type: Interventional

Summary: 
      The purpose of this randomized, double-blind, 2-period crossover trial was to assess the
      satisfaction of edentulous patients and their oral health impact profile when provided with
      complete dentures fabricated using the conventional and simplified techniques.
    

Detailed description: 
      40 completely edentulous patients, aged 40-85 years, with no relevant medical conditions,
      seeking complete dentures at a university hospital were included in this study. Those were
      randomly divided into two groups (n=20). Each group received two sets of dentures, the Group
      (S) were given the dentures constructed using the simplified technique first while the Group
      (C) received the dentures constructed using the conventional technique. After 1 month of the
      first set of dentures delivery, participants were asked to rate their general satisfaction on
      a 10-cm visual analogue scale in addition to their satisfaction regarding comfort, retention,
      stability, efficiency of mastication and speaking. Participants were also asked to fill the
      20-item oral health impact profile for edentulous patients (OHIP-EDENT). Thereafter, each
      group of patients were given the set of dentures constructed using the other technique, given
      instructions and recalled after 1 month to evaluate the alternate set of dentures. 2
      Prosthodontists performed all the clinical procedures and 1 laboratory technician performed
      the laboratory procedures. The results of the study were analyzed using Wilcoxon-signed rank
      test at significance level of 0.05.
    

Intervention name(s): Denture Fabrication technique
Intervention type(s): Procedure
Intervention description(s): Each patient received two sets of dentures fabricated using the two different techniques and their satisfaction and OHIP-EDENT were compared
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Keywords: Simplified dentures; impression techniques; complete edentulism; border moulding
Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine
Condition: Infections, Streptococcal; Streptococcal Infections
MeSH terms: Infections; Communicable Diseases; Streptococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to
      40 years of age the safety and immunogenicity of a liquid formulation of Group B
      Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration),
      and of the lyophilized formulation of GBS Trivalent Vaccine, administered in non-pregnant and
      pregnant women in the clinical development program to date.
    


Intervention name(s): GBS Vaccine; GBS Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus; Lyophilized formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GBS; vaccine comparability; Group B Strep
Clinical Trial Assessing Toxicity and Efficacy of MF101 for Hot Flashes
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 2

Summary: 
      The researchers propose a Phase II randomized, double-blind, placebo-controlled trial of 180
      healthy postmenopausal women experiencing at least 5 hot flashes per day or 35 hot flashes
      per week. Women will be randomized to one of three arms: 4.5 grams/day (dry weight of
      extract) of MF101, 9.0 grams/day (dry weight of extract) of MF101 or placebo for 12 weeks.
    


Intervention name(s): MF101
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Postmenopausal symptoms; Hot Flashes; Postmenopausal Hot Flashes
ACT-128800 in Patients With Moderate to Severe Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in
      patients with moderate-to-severe chronic plaque psoriasis.
    


Intervention name(s): ACT-128800; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily; ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily
Intervention MeSH terms: Ponesimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: psoriasis; chronic plaque psoriasis; Moderate to severe chronic plaque psoriasis