bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will aim to assess of the clinical efficacy and safety of dapoxetine, combined
      dapoxetine with folic acid and combined dapoxetine with vitamin B12 in treatment of patients
      with premature ejaculation: A randomized placebo-controlled clinical trial.
    

Detailed description: 
      In a single-blind placebo-controlled clinical study, it will be carried out on 120 patients
      with PE.

      All patients will be randomized equally divided into four groups (30 patients each).

      Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.

      Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse. Group 3 was given
      on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg
      folic acid.

      Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral
      supplementation of 0.5 mg vitamin B12
    

Intervention name(s): Multi-Vitamin Tablets; Dapoxetine; Dapoxetine and folic acid.; Dapoxetine and vitamin B12
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.; The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse.; The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.; The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse. Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12
Intervention MeSH terms: Vitamins; Folic Acid; Vitamin B 12; Hydroxocobalamin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All patients will be randomized equally divided into four groups (30 patients each).
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Premature Ejaculation
Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants
Condition: Pneumonia; Pneumococcal Infections; Streptococcus Pneumoniae Infections
MeSH terms: Infections; Communicable Diseases; Pneumonia; Pneumonia, Pneumococcal; Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to explore the safety and tolerability of an investigational
      pneumococcal vaccine through a step-down enrollment.

      Primary Objective:

        -  To evaluate the safety and tolerability of an investigational pneumococcal vaccine.

      Secondary Objective:

        -  To evaluate the immunogenicity of an investigational pneumococcal vaccine.
    

Detailed description: 
      All adult participants will receive a single injection of study vaccine or placebo. After
      satisfactory safety evaluation, toddler participants will receive a single injection of study
      vaccine or placebo. After satisfactory safety evaluation, infant participants will receive 3
      injections of study vaccine or placebo in dose-ascending order (low, medium, and high dose),
      with a safety evaluation after each dose level before the study proceeds to the next higher
      dose. All participants will undergo immunogenicity testing and monitoring for safety.
    

Intervention name(s): Pneumococcal Vaccine High Dose (Formulation 1); Tris buffered saline (Placebo); Pneumococcal Vaccine High Dose (Formulation 1); Tris buffered saline (Placebo); Pneumococcal Vaccine Low Dose (Formulation 2); Tris buffered saline (Placebo); Pneumococcal Vaccine Middle Dose (Formulation 3); Pneumococcal Vaccine Middle Dose (Formulation 4); Tris buffered saline (Placebo); Pneumococcal Vaccine High Dose (Formulation 1); Tris buffered saline (Placebo)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Tris buffered saline; Tris buffered saline; Tris buffered saline; Tris buffered saline; Tris buffered saline
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pneumonia; Pneumococcal Infections; Streptococcus pneumoniae Infections; Pneumococcal vaccines
The Effect of Intraoperative Body Temperature on Postoperative Nausea and Vomiting in Pediatric Patients
Condition: Perioperative Body Temperature; Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Observational [Patient Registry]

Summary: 
      The aim of our study was to investigate the effects of changes in body temperature in the
      perioperative period on postoperative nausea and vomiting.
    

Detailed description: 
      Undesirable hypothermia is that the perioperative body temperature is below 36 ° C.
      Perioperative heat loss is higher in pediatric patients than in adult patients. One of the
      most common side effects of general anesthesia is nausea and vomiting. The aim of our study
      was to investigate the effects of changes in body temperature in the perioperative period on
      postoperative nausea and vomiting.We planned to perform prospectively in 80 children with ASA
      I according to the American Society of Anesthesia (ASA) Anesthesia Risk Scale between 6
      months and 7 years of age in both sexes who underwent inguinal hernia, undescended testes and
      hydrocele surgery. In all patients, heating blanket was placed on the operation table and
      standard heat was used. After the placement of the LMA, a nasopharyngeal heat probe was
      placed for central body temperature measurement and monitored throughout the operation. Mean
      arterial pressure, heart rate and body temperature were recorded. Demographic data, type of
      operation, duration of operation and intraoperative fentanyl requirement of all cases were
      recorded. Analgesic and antiemetic requirements, presence of nausea and vomiting (according
      to numerical sequence scale) were recorded in the recovery room at 6, 12 and 24 hours
      postoperatively
    

Intervention name(s): body temperature measurement
Intervention type(s): Other
Intervention description(s): Postoperative analgesic and antiemetic requirements, nausea and vomiting were observed in the recovery room at 6, 12 and 24 hours
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ASA1 group, 80 children, both sexes, aged 6 months to 7 years
      
Keywords: perioperative body tempreture; hypothermia; PONV; Postoperative nausea and vomiting
Effects of Whole Sprouts on Airway Allergic Inflammation
Condition: Allergic Rhinitis; Asthma; Allergy
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Inflammation
Study type: Interventional

Summary: 
      The primary objective of this study is to determine if broccoli sprouts (BS) improves airway
      inflammatory, oxidative stress (OS), and symptoms among asthmatic adults with aeroallergen
      sensitization.

      The study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo in
      40 adults with asthma. 40 adults (age 18-50) who meet these eligibility criteria will be
      randomized to receive either: (a) BS or (b) placebo (alfalfa sprouts). Subjects will eat a
      sprouts sandwich daily for three days, and then undergo repeat measurement of outcomes.
    


Intervention name(s): Broccoli Sprouts; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100g of either broccoli or alfalfa sprouts will be eaten daily in a sandwich or wrap form.; Alfalfa Sprouts
Other intervention name(s): sprouts, broccoli sprouts; sprouts, alfalfa, broccoli sprouts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma; allergic rhinitis; dietary interventions; mouse allergy
Effect of an Optimized Savory Cluster on Glycemic and Insulinemic Responses in Healthy Individuals
Condition: Peak Rise of Blood Glucose
Study type: Interventional

Summary: 
      This study was to test the hypothesis that an optimized savory cluster (Test-cluster) made
      through a proprietary baking process combined with slow digestible carbohydrates and fiber
      will elicit lower postprandial blood glucose and insulin responses than a Control-cluster
      made from general processing procedure and with typical ingredients commonly used in
      commercially available snacks or bars: oats, peanuts, and corn syrup. However, since the
      Test-cluster contains ~30% less available-carbohydrate (24g) than the Control (33g), the
      postprandial responses elicited by the Test-cluster was also compared with those after a
      portion of White-bread matched for available-carbohydrate content. On 3 separate days, 25
      healthy male or non-pregnant females aged 18-60 yr with BMI between 20 and 35 kg/m² with
      fasting serum glucose <7.0mmol/L (126 mg/dL) were asked to consume 1 serving (56g) of the
      Test- or Control-cluster or 47g White Bread and had blood glucose and insulin measured at
      intervals over the next 4 hr. Each serving of Test-cluster and Control-cluster contained
      similar amounts of total carbohydrates, protein, fat and energy content. Each serving of
      Test-cluster and White-bread had equivalent amount of 24g available carbohydrate.

      On each test occasion, after subjects were weighed, 2 fasting blood samples were obtained by
      finger-prick 5min apart and after the 2nd sample, the subject started to consume a test meal.
      Subjects were asked to consume the entire test meal within 10 min. At the first bite a timer
      was started and blood samples for were taken for glucose analysis at 10, 20, 30, 40, 50, 60,
      90, 120, 180 and 240 min after starting to eat. Additional blood was taken into a separate
      vial at -5, 0, 20, 40, 60, 90, 120, 180 and 240 min for insulin analysis. Blood samples were
      obtained from hands warmed with an electric heating pad for 3-5 min prior to each sample.
      During the 4hr of the test, participants remained seated quietly. After the last blood sample
      participants were offered a snack and then allowed to leave.
    


Intervention name(s): Test Cluster
Intervention type(s): Other
Intervention description(s): Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Corneal Sensitivity Cross-linking Keratoconus
Condition: Keratoconus
MeSH terms: Keratoconus; Hypersensitivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To evaluate corneal sensitivity changes following corneal cross-linking (CXL) in patients
      with progressive lower stage keratoconus.
    

Detailed description: 
      Thirty eight eyes of 19 patients (11 women, 8 men) were included in a prospective,
      nonrandomized clinical study. Mean patient age was 22 years (range, 18-26 years). Inclusion
      criteria were low stage bilateral progressive keratoconus, transparent cornea and thinnest
      corneal thickness ≥ 440 µm. Using the Cochet-Bonnet esthesiometer central corneal sensitivity
      was measured preoperatively, after 7 days, and once a month after surgery until recovery of
      the baseline preoperative level. Normal levels of central corneal sensitivity were considered
      above 40mm.
    

Intervention name(s): Cochet-Bonnet esthesiometer central corneal sensitivity
Intervention type(s): Other
Intervention description(s): Using the Cochet-Bonnet esthesiometer central corneal sensitivity was measured preoperatively, after 7 days, and once a month after surgery until recovery of the baseline preoperative level. Normal levels of central corneal sensitivity were considered above 40mm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Corneal sensitivity; Cross-linking; Keratoconus
Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Overweight and obesity is defined, according to the World Health Organization (WHO), by
      abnormal or excessive accumulation of adipose or fatty tissue that may be harmful to health.

      Overweight and obesity are therefore important determinants of health, which expose people to
      many pathologies whose consequences for individuals are not only health, but also social:
      stigma, prejudice, discrimination.

      Indeed, most overweight people have a bad image of themselves. For some people, overweight
      can trigger stress, malaise and disgust.

      To break free from this malaise and satisfy the growing desire of women to take care of their
      body, many products are present in the slimming beauty market.

      EFFANACA3GEL is a prospective, randomized, double-blind, placebo controlled study. 208
      healthy volunteers will be followed for 2 months during which they will use ANACA3 slimming
      gel. The aim of this study is to evaluate the effects of ANACA3 slimming gel on hip and waist
      circumferences.
    


Intervention name(s): Slimming gel; Slimming gel placebo
Intervention type(s): Other; Other
Intervention description(s): On the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks.; On the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks.
Other intervention name(s): ANACA3 Le Gel Minceur; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Overweight; Obesity; Slimming gel; Cosmetic product; Waist circumference; Thigh circumference
Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using
      tamoxifen or LY353381 may fight breast cancer by blocking the use of estrogen.

      PURPOSE: This randomized phase I trial is studying how well tamoxifen works on the biomarkers
      of the tumor tissue, compared with LY353381, in treating women with newly diagnosed breast
      cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether LY353381 hydrochloride or tamoxifen administered in the interval
           between biopsy and re-excision alters the expression of tissue biomarkers relative to
           placebo controls in postmenopausal women with newly diagnosed breast cancer.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.

        -  Phase I: Patients are randomized to receive either oral LY353381 hydrochloride or oral
           placebo daily.

      Upon completion of phase I, all treatment centers begin phase II of the study.

        -  Phase II: Patients are randomized to receive either oral tamoxifen or oral placebo
           daily.

      Treatment in both phases continues for 2-6 weeks (until scheduled lumpectomy or mastectomy)
      in the absence of disease progression or unacceptable toxicity.

      Patients are followed at 1 and 2 weeks after surgery.

      PROJECTED ACCRUAL: A minimum of 120 patients (60 per treatment phase) will be accrued for
      this study within 18 months.
    

Intervention name(s): arzoxifene hydrochloride; tamoxifen citrate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: stage I breast cancer; stage II breast cancer; ductal breast carcinoma in situ; breast cancer in situ
Safety and Efficacy of Etanercept (Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein [TNFR:Fc]) in Children With Juvenile Rheumatoid Arthritis (JRA)
Condition: Juvenile Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Juvenile; Necrosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of this study was to determine the efficacy of etanercept in children
      with polyarticular course JRA.
    

Detailed description: 
      This was a two-part study. In the first part of the study, all participants received
      open-label etanercept twice a week for 90 days. At the end of the 90 days, participants with
      disease response as defined by the JRA Definition of Improvement (DOI) using the JRA Core Set
      Criteria were randomized in part 2 of the study to receive placebo or continued
      administration of etanercept until either disease flare occurred or 4 months elapsed,
      whichever was earlier.

      Participants who did not meet the DOI at day 90, participants who had disease flare during
      part 2 and participants who completed the blinded part of the study were eligible to receive
      open-label treatment with etanercept under protocol 16.0018 (NCT00357903).
    

Intervention name(s): Etanercept; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered twice weekly by subcutaneous injection; Administered twice weekly by subcutaneous injection
Other intervention name(s): Enbrel; TNFR:Fc
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Phase 2 Study to Evaluate Safety, Pharmacokinetics, Immunogenicity and Pharmacodynamics/Efficacy of EDI200 in Male Infants With X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)
Condition: X-Linked Hypohidrotic Ectodermal Dysplasia
MeSH terms: Ectodermal Dysplasia; Ectodermal Dysplasia 1, Anhidrotic; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 first-in-neonate EDI200 study will enroll treatment-naïve, XLHED-affected male
      newborns in the first two weeks of life. All subjects will meet entry criteria including
      documentation of an Ectodysplasin (EDA) mutation associated with XLHED. Following Baseline
      evaluations, EDI200 dosing will be initiated between day-of-life 2 and 14, with each study
      subject receiving 2 doses/week for a total of 5 doses. The study will enroll subjects in two
      cohorts with subjects in cohort 1 dosed at 3 mg/kg/dose, associated with partial efficacy,
      and cohort 2 dosed at 10 mg/kg/dose where enhanced efficacy was demonstrated in the most
      relevant preclinical model. Given the challenge of identifying families where the subject is
      yet to be born, it is expected that cohort size and time for recruitment will be variable.
    

Detailed description: 
      This Phase 2 first-in-neonate EDI200 study will enroll treatment-naïve, XLHED-affected male
      newborns in the first two weeks of life. All subjects will meet entry criteria including
      documentation of an EDA mutation associated with XLHED. Following Baseline evaluations,
      EDI200 dosing will be initiated between day-of-life 2 and 14, with each study subject
      receiving 2 doses/week for a total of 5 doses. This dosing regimen mirrors that used to
      enhance efficacy in the dog XLHED model, considered to be most relevant to the clinical study
      design. The study will enroll subjects in two cohorts with subjects in cohort 1 dosed at 3
      mg/kg/dose, associated with partial efficacy, and cohort 2 dosed at 10 mg/kg/dose where
      enhanced efficacy was demonstrated in the most relevant preclinical model. Given the
      challenge of identifying families where the subject is yet to be born, it is expected that
      cohort size and time for recruitment will be variable. The sponsor anticipates enrollment and
      dosing of 6-10 subjects over a 12-18 month period, 3-5 subjects per cohort.
    

Intervention name(s): EDI200
Intervention type(s): Drug
Intervention description(s): 3 or 10 mg/kg of EDI200
Other intervention name(s): APO200
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypohidrotic Ectodermal Dysplasia; XLHED