bioihbjkbjnl/mcl2 huggingface dataset:
A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
Condition: HIV-1 Infections
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of
      dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as
      compared to the vaginal HEC-based Universal placebo gel, 2.5 g in healthy HIV-negative women
    

Detailed description: 
      This was a double-blind, randomized, placebo-controlled trial, to be conducted over 10 months
      at five research centers in the USA among 180 healthy, sexually active women, to assess the
      safety and acceptability of dapivirine Gel 4759, 0.05% 2.5 g, and dapivirine Gel 4789, 0.05%
      2.5 g, both vaginal microbicides containing dapivirine, compared to the vaginal HEC-based
      Universal placebo gel, 2.5 g, containing no active ingredient, used once daily for a period
      of 12 weeks.
    

Intervention name(s): dapivirine 4789; dapivirine gel 4759; Drug placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): dapivirine gel 4789, 0.05%, 2.5g applied once daily; dapivirine gel 4759, 0.05%, 2.5g applied once daily; HEC-based universal placebo gel, 2.5g applied once daily
Other intervention name(s): TMC120; TMC120; HEC-based placebo gel, 2.5g
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All enrolled participants will apply gel on a daily basis for 12 weeks, with clinical follow-up visits at weeks 2,4,8 and 12 to monitor safety and acceptability, and a final visit 4 weeks post gel discontinuation (Visit 6, week 16) Dapivirine concentration will be measured in blood and vaginal fluid and cervical tissue.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV-1 infections
Alveolar Bone Graft Cortical Nasal Floor
Condition: Alveolar Cleft Operated on an Alveolar Bone Graft
Study type: Observational

Summary: 
      Alveolar bone graft is one of the main step of the surgical care of the patients who are
      suffering from cleft lip and palate. They are usually performed before the lateral incisor
      eruption, at about 5 years old and using cancellous bone taken from the iliac crest.

      The aim of the study is to show if adding a cortical graft to the cancellous cause more
      complications, which may be source of partial or total graft loss in the 6 month following
      the observation
    

Detailed description: 
      This is an observational, retrospective and monocentric study. To be included, patients had
      to suffer from a clef lip and palate or alveolar cleft and had to have an alveolar bone graft
      with gingivo-periosteoplasty in the pediatric plastic surgery unit of the Montpellier
      hospital from June 1999 to Mai 2016. They were divided into two groups : the first with
      patients who had a cortical and cancellous bone graft and the second with patients who had a
      cancellous graft only.

      Both groups were followed 6 mounts after the operation to look for the occurence of
      complications which lead to a graft loss. Bilateral cleft are seen as 2 graft events
    

Intervention name(s): alveolar bone graft with cancellous bone and a cortical block; alveolar bone graft with cancellous bone only
Intervention type(s): Procedure; Procedure
Intervention description(s): alveolar bone graft with cancellous bone only; alveolar bone graft with cancellous bone only
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are suffering from clef lip and palate or alveolar cleft and had to have an
        alveolar bone graft with gingivo-periostoplasty in the pediatric plastic surgery unit of
        the Montpellier hospital from June 1999 to Mai 2016
      
Keywords: alveolar graft; cancellous bone; cortical block; nasal floor
Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess immunogenicity and safety of MenABCWY vaccine in
      healthy adolescents and adults aged 15 to 25 years previously vaccinated with MenACWY vaccine
    


Intervention name(s): MenABCWY vaccine; Placebo; MenACWY vaccine; MenB vaccine
Intervention type(s): Combination Product; Combination Product; Biological; Combination Product
Intervention description(s): 2 doses of MenABCWY vaccine administered intramuscularly on Day 1 and Day 181 to participants in ABCWY group.; 1 dose of placebo administered intramuscularly on Day 211 to participants in ABCWY group; 1 dose of MenACWY vaccine administered intramuscularly on Day 1 to participants in ACWY group; 2 doses of MenB vaccine administered intramuscularly on Day 181 and Day 211 to participants in ACWY group. MenB vaccine is a non-investigational medical product (NIMP) in this study and is administered only in compliance with standard of care.
Other intervention name(s): Menveo; Bexsero
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Neisseria meningitidis; Meningococcal disease
The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold
Condition: Healthy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain.The
      vast majority of basic science studies suggested a large effect of oxytocin in minimizing
      acute pain.Few studies have demonstrated an association between plasma levels of oxytocin and
      pain in humans. Since addictive properties of oxytocin have not been described, the drug may
      have important application in the management of acute and chronic pain. No studies have
      examined the effect of intranasal oxytocin on pain sensitivity and threshold.
    


Intervention name(s): Intervention 1; Washout Period; Intervention 2
Intervention type(s): Procedure; Behavioral; Procedure
Intervention description(s): Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of study drug prior to Thermal Evaluation System Testing on intervention 1 (Day 1).; The wash-out period will be between intervention 1 and intervention 2. 13 days in length.; Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of study drug prior to Thermal Evaluation System Testing on intervention 2 (Day 14).
Other intervention name(s): Day 1; Day 14
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Volunteers
Study in Healthy Male Subjects to Investigate Whether Ketoconazole Affects Plasma Exposure of BI 113823
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to investigate whether ketoconazole affects plasma exposure of
      BI 113823
    


Intervention name(s): BI 113823 + Ketokonazole; BI 113823
Intervention type(s): Drug; Drug
Intervention description(s): 5 days ketokonazole with single oral dose of BI 113823 on day 3; single oral dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Understanding the Persistence of Immunity After MenC Vaccines
Condition: Healthy
Study type: Observational

Summary: 
      Neisseria meningitidis occurs worldwide as endemic disease1 and is a major cause of invasive
      infections such as meningitis and septicaemia. Three protein-polysaccharide conjugate
      serogroup C meningococcal (MenC) vaccines were developed in the late 1990's and an
      accelerated programme of clinical trials in the UK led to licensure of these MenC vaccines in
      1999 and these vaccines were introduced into the routine infant immunisation schedule at 2, 3
      and 4 months. However, children who were aged 1-18 years in 2000 only received a single dose
      of a MenC conjugate vaccine during the mass immunisation campaign.

      Previous studies have demonstrated rapid waning of MenC specific antibody concentrations and
      serum bactericidal antibody (SBA) titres following immunisation in young children. A
      cross-sectional review on rates of sero-protection against MenC disease in the UK has
      demonstrated that the majority of children who were immunised with a single dose of a MenC
      conjugate vaccine between the ages of 1-10 did not have protective titres of MenC SBA 7 years
      after the immunisation campaign. As this cohort of children reaches adolescence there is a
      risk of increased transmission of the organism and a resurgence of meningococcal disease in
      children who do not have protective levels of antibody. There is thus a need to conduct a
      study evaluating the changes in MenC SBA titres over time in children who received a single
      dose of a MenC vaccine in early childhood which is the main objective of this study.
    


Intervention name(s): Venepuncture
Intervention type(s): Procedure
Intervention description(s): Venepuncture and blood sample collection in 2010 in a sample of children who received a single dose of a MenC conjugate vaccine at age 1-3 years 10 years earlier.
A booster dose of a MenC conjugate vaccine (optional).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy children who participated in the U01-Td5I-303/ C01.183 study from 2001 to 2007 who
        will be aged 11 to 13 years in 2010, all of whom would have received a single dose of a
        MenC conjugate vaccine in 2000 as part of the nationwide immunisation campaign.
      
Keywords: MenC conjugate vaccine; Healthy children previously vaccinated against MenC
Study to Evaluate ASN008 Topical Gel (TG)
Condition: Dermatitis, Atopic; Pruritus; Dermatitis Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Pruritus
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an ascending dose escalation study to test the safety, tolerability and preliminary
      efficacy of ASN008 TG in first-in-human subjects
    

Detailed description: 
      This is a two part, randomized, blinded, vehicle-controlled study to determine a safe and
      tolerable dose of ASN008 TG. Part A will asses a single ascending dose of ASN008 TG in
      cohorts of healthy volunteers, while Part B will assess multiple ascending doses of TG, to be
      determined (TBD) based on Part A safety and tolerability, in patients with mild-to-moderate
      dermatitis. Results from Part A and B will characterize safety, tolerability and
      pharmacokinetics. Part B patients will be assessed for changes in pruritus based on a
      numerical rating scale (NRS) of pruritus at baseline and on Day 15.
    

Intervention name(s): ASN008 TG; Placebo TG
Intervention type(s): Drug; Drug
Intervention description(s): ASN008 TG; Placebo TG
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 1, multicenter, double-blind, vehicle-controlled, randomized ascending doses trial.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia
Condition: Schizophrenia; Fatty Acid Deficiency
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this research study is to find out what effects (good and bad) that omega-3
      fatty acids has on schizophrenia.
    

Detailed description: 
      The two aims of the study test the hypotheses that correcting omega-3 fatty acid deficiency
      in the early stages of schizophrenia improves positive symptom treatment response, negative
      symptom treatment response, and cognition symptom response.
    

Intervention name(s): Omega-3 Fatty Acids; Olive oil placebo; EPA fish oil concentrate; DHA fish oil concentrate; Placebo
Intervention type(s): Dietary Supplement; Other; Dietary Supplement; Drug
Intervention description(s): Essential omega-3 fatty acid replacement therapy with Eicosapentaenoic acid at 3.2 grams
Docosahexaenoic acid fish oil concentrate at 1.6 grams; Olive oil capsules, 8 capsules per day; 3.2 grams for EPA 1.6 grams for DHA; Olive oil capsule
Other intervention name(s): EPA; DHA; Olive oil; Eicosapentaenoic acid (EPA); Docosahexaenoic acid (DHA); Olive oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Comparison of Fetal Thymus Volumes of Pregnant Women With In Vitro Fertilization (IVF) and Spontaneous Pregnant Women.
Condition: Healthy
Study type: Observational [Patient Registry]

Summary: 
      The purpose of the study was to compare the fetal thymus volumes of 18-24-week pregnant women
      with In Vitro Fertilization (IVF) and spontaneous pregnant women.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study group consisted of normal pregnant women who applied to the pregnancy clinic for
        routine pregnancy follow-ups
      
Keywords: Fetal thymus volume; In vitro fertilization
Study to Assess the Absorption and Tolerability of Intranasal Ketorolac Tromethamine and to Assess the Effects of Oxymetazoline Hydrochloride and Fluticasone Propionate on the Absorption and Tolerability of Intranasal Ketorolac Tromethamine in Participants With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      This was an open label, three way study in participants with symptomatic allergic rhinitis.
      The following 3 treatments were administered to each subject during dosing periods 1, 2 and
      3, respectively:

        -  Treatment A: Single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray
           into each nostril) on Day 1 of Period 1.

        -  Treatment B: Single intranasal dose of oxymetazoline hydrochloride followed by a single
           intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30
           minutes later on Day 1 of Period 2.

        -  Treatment C: Seven days of treatment with intranasal fluticasone propionate (between
           Periods 2 and 3) followed by a single intranasal dose of 30 mg ketorolac tromethamine
           (one 15 mg spray into each nostril) on Day 1 of Period 3.

      Subjects remained resident in the Clinical Unit from Day 1 until the morning of Day 2 in each
      period and there was a washout period of 2 to 7 days between periods. A post study medical
      was performed within 7 days of Period 3.

      The objectives of this study were:

        -  To assess the pharmacokinetics (PK) of intranasal ketorolac in participants with
           symptomatic allergic rhinitis.

        -  To assess the effects of a single dose of intranasal oxymetazoline hydrochloride on the
           pharmacokinetics and tolerability of intranasal ketorolac in participants with
           symptomatic allergic rhinitis.

        -  To assess the effects of chronic administration of fluticasone propionate on the
           bioavailability and tolerability of intranasal ketorolac in participants with
           symptomatic allergic rhinitis.
    


Intervention name(s): Ketorolac Tromethamine; Oxymetazoline Hydrochloride; Fluticasone Propionate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on Day 1 of Period 1; Single intranasal dose of oxymetazoline hydrochloride followed by a single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2; Seven days of treatment with intranasal fluticasone propionate (between Periods 2 and 3) followed by a single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on Day 1 of Period 3
Intervention MeSH terms: Fluticasone; Xhance; Ketorolac; Ketorolac Tromethamine; Phenylephrine; Oxymetazoline
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Er:YAG Laser on Hydrophilic Sealants
Condition: Fissure Sealant
Study type: Interventional

Summary: 
      This study was conducted on 44 (19 girls and 25 boys) patients presenting 132 permanent first
      molars, who applied for oral examination to Adnan Menderes University Faculty of Dentistry
      Department of Pediatric Dentistry. The patients involved in the study were aged between 7-11
      years who had fully erupted permanent first molars, which were suitable for non-invasive
      fissure sealant application (narrow, deep fissures).
    

Detailed description: 
      The permanent first molar teeth were cleaned using a polishing brush and pumice and isolated
      with cotton rolls. Caries status was assessed using DIAGNOdent pen (DIAGNOdent pen 2190,
      KaVo, Biberach, Germany) at the occlusal and proximal sites. Teeth having DIAGNOdent readings
      of 12 or less at the occlusal site and 7 or less at the proximal site were included in the
      study. Then, the teeth were divided into three groups. The first group (Grup A) of teeth were
      etched with phosphoric acid, the second group of teeth (Group L) were etched with Er:YAG
      laser and the third group of teeth (Group A+L) were etched with both Er:YAG laser and
      phosphoric acid. The patients were recalled for follow up examination at the 3rd, 6th and 9th
      months. The teeth were assessed using mouth mirror and explorer regarding new caries
      formation and retention of the fissure sealants. The obtained data were analyzed using SPSS
      24.0 (SPSS 24.0 for Windows, SPSS Inc., Chicago, IL, USA).
    

Intervention name(s): Laser etching
Intervention type(s): Device
Intervention description(s): Acid etching
Other intervention name(s): Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
Condition: Narcolepsy; Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Narcolepsy; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110
      in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or
      ADX-N05 202.
    


Intervention name(s): JZP-110
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines
Condition: Japanese Encephalitis; Hepatitis A
MeSH terms: Hepatitis A; Encephalitis, Japanese; Hepatitis; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in
      toddlers aged 12-18 months.

      Primary objective:

      To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi
      pasteur.

      Secondary objective:

      To describe the safety of vaccination in all subjects
    

Detailed description: 
      This is a Phase III trial in toddlers in Thailand and the Philippines.
    

Intervention name(s): Japanese encephalitis vaccine; Japanese encephalitis vaccine; Japanese encephalitis vaccine; Japanese encephalitis vaccine (Acambis); Hepatitis A vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Intramuscular
Other intervention name(s): ChimeriVax™-JE; ChimeriVax™-JE; ChimeriVax™-JE; Avaxim® 80U Pediatric
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Japanese encephalitis, Hepatitis A, Inactivated Mouse-Brain
Lifestyle vs.Surgery for Morbid Obesity Treatment
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the current study is to determine whether an intensive lifestyle intervention
      was as effective as surgery to treat morbid obesity nine years post-intervention.
    

Detailed description: 
      Behavioral/lifestyle interventions produce acceptable success in treating moderately obese
      subjects. However, their effectiveness on weight loss and maintenance in morbidly obese
      subjects remains elusive.

      Twenty-nine morbidly obese females participated in this non-randomized study. Fifteen
      subjects were assigned to the lifestyle group and 14 underwent vertical banded gastroplasty.
      Subjects in the lifestyle group attended 30 behavioral modification sessions over three
      years, whereas the surgery group received the standard of care nutrition. Body weight,
      resting metabolic rate, physical activity, body composition measurements and dietary intake
      data were assessed at standard time points during the first 3 years post-intervention.
      Follow-up data on body weight and physical activity were also collected 9 years later.
    

Intervention name(s): Lifestyle counselling; Bariatric Surgery
Intervention type(s): Behavioral; Procedure
Intervention description(s): Behavioral techniques for weight management; Vertical Banding Gastroplasty
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lifestyle intervention; Bariatric surgery; Weight management; Physical activity
A Single and Multiple Ascending-dose Trial of LEO 153339 in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human study in adult healthy participants consisting of two parts. In Part
      1, participants will receive one dose of study drug (LEO 153339) or placebo; in Part 2,
      participants will receive multiple doses of study drug or placebo.

      The participants will stay in the clinic for 6 days (Part 1) or for 12 days (Part 2) to have
      the study doctor assess their safety and to investigate how quickly and to what extent LEO
      153339 (and the breakdown product) is absorbed, transported, and eliminated from the body.

      The purpose is to assess the safety and tolerability of LEO 153339 when compared to a placebo
      with no active ingredient.
    


Intervention name(s): LEO 153339; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LEO 153339; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment