bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Safety Study of Inactivated Split Influenza Vaccine' in Healthy Korean Male Subjects
Condition: Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated
      Split Influenza Vaccine (IL-YANG FLU Vaccine Vial INJ.) administered as a single
      intramuscular injection
    

Detailed description: 
      This was an open-label study. Subjects providing voluntary written informed consent underwent
      protocol-specific assessments and tests within 4 weeks prior to administration of the study
      vaccine, and those who met all of the inclusion/exclusion criteria and were considered
      eligible were sequentially enrolled in the study.

      Subjects enrolled in the study received 0.5ml of the study vaccine as an intramuscular
      injection in the deltoid muscle, and returned to the clinic every day for the first 3 days.
      On Day 14 post-vaccination, subjects underwent the safety assessments. On Day 28
      post-vaccination, subjects returned for safety and immunogenicity assessments.
    

Intervention name(s): IL-YANG FLU Vaccine
Intervention type(s): Biological
Intervention description(s): 0.5mL
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Influenza vaccine; Split influenza vaccine
Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer
Condition: Testicular Germ Cell Tumor
MeSH terms: Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, ifosfamide, and
      cisplatin in treating patients who have metastatic testicular cancer that has recurred
      following treatment.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the feasibility of combining paclitaxel, ifosfamide, and cisplatin induction
           in patients with metastatic nonseminomatous germ cell tumor of the testis in first
           relapse following first line treatment with bleomycin, etoposide, and cisplatin.

        -  Determine the response rates to this regimen in these patients

      OUTLINE: This is a multicenter study.

      Patients receive paclitaxel IV over 3 hours and ifosfamide IV and cisplatin IV daily for 5
      days. Patients with stable or responding disease repeat treatment every 3 weeks for 4 courses
      in the absence of disease progression or unacceptable toxicity.

      PROJECTED ACCRUAL: A minimum of 25 patients will be accrued for this study.
    

Intervention name(s): cisplatin; ifosfamide; paclitaxel
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Paclitaxel; Ifosfamide
Primary purpose: Treatment
Keywords: stage III malignant testicular germ cell tumor; recurrent malignant testicular germ cell tumor; testicular embryonal carcinoma; testicular choriocarcinoma; testicular teratoma; testicular yolk sac tumor; testicular embryonal carcinoma and teratoma; testicular embryonal carcinoma and yolk sac tumor; testicular yolk sac tumor and teratoma; testicular choriocarcinoma and yolk sac tumor; testicular choriocarcinoma and embryonal carcinoma; testicular choriocarcinoma and teratoma
Multi-polar RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
Condition: Vulvovaginal Atrophy; Menopause; Menopause Surgical
Study type: Interventional

Summary: 
      The study evaluates the use of multi-polar radiofrequency (RF) and pulsed electro-magnetic
      fields (PEMF) energies for the treatment of vaginal looseness and for the treatment of the
      mons pubis and labia for skin tightening. All subjects will receive a total of three internal
      and three external treatments at four week intervals. Subjects will be followed up at one and
      four months after treatment is complete.
    

Detailed description: 
      Traditional non-surgical treatments to treat vaginal looseness include Kegel exercises or
      pelvic floor therapy with electrical stimulation of the vaginal muscles to promote muscle
      strength but may not be all that effective. Surgery is also used to tighten the vaginal canal
      and reduce the size of the mons pubis and the outer labial lips but can be associated with
      surgical complications. Development of new technologies to address these concerns is
      warranted.

      Mutil-polar radiofrequency (RF) therapy to treat stress incontinence (attributed to looseness
      of the muscles that control the ability to hold urine) and looseness of the facial and neck
      skin has been used with success and minimal risk. The addition of pulsed electromagnetic
      field (PEMF) energy to multi-polar RF therapy has also been shown to improve the results of
      the RF therapy.

      RF therapy has already been reported to be successful in vaginal tightening. This study will
      investigate whether adding PEMF to RF therapy is safe and efficacious for the treatment of
      vaginal loosenss. In addition, this study will also investigate whether RF and PEMF energy
      treatment will improve the looseness of the mons pubis and labia.
    

Intervention name(s): Vulvovaginal treatment; Baseline
Intervention type(s): Device; Device
Intervention description(s): Radiofrequency and pulsed electro-magnetic fields treatment of the vaginal canal to maintain an internal temperature of approximately 42 C for the proximal thermometer and 45 C for the mid and distal thermometers for 15 minutes.
Radiofrequency and pulsed electro-magnetic fields treatment of the labia to maintain an external temperature of approximately 40 C - 45 C for 15 minutes.
Radiofrequency and pulsed electro-magnetic fields treatment of the mons pubis to maintain an external temperature of approximately 40 C - 47 C for 15 minutes.; Subject is acting as their own control. The baseline general appearance photograph will act as the comparator.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Step Up Versus Step Down in Controlled Ovarian Stimulation
Condition: No Explained Sterility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to evaluate if the Step up protocol is equal or superior regarding
      efficacy and security than the step down protocol. In couple submitted two intrauterine
      insemination.
    


Intervention name(s): FSH-r (Follicule stimulate hormone)
Intervention type(s): Drug
Intervention description(s): Step-Up: 75 IU FSH-r Step-Down: 150 FSH-r
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sterility; FSH-r; intrauterine insemination; unexplained sterility
Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay
Condition: Developmental Disabilities; Feeding Disorder
MeSH terms: Developmental Disabilities; Feeding and Eating Disorders
Study type: Observational

Summary: 
      A retrospective chart review to assess feeding tolerance in children who had been switched
      from an intact protein formula to a Peptide based formula due to feeding intolerance in a
      pediatric facility for the developmentally delayed.
    

Detailed description: 
      Medical records of pediatric patients with enteral feeding intolerance on standard polymeric
      formulas that were switched to a peptide based formula will be retrospectively analyzed. Data
      will be collected on caloric intake, ability to meet enteral nutrition goals, incidence of
      intolerance, and the use of medications to control gastrointestinal symptoms.
    

Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The population studied retrospectively will be pediatric patients with developmental delays
        dependent on enteral nutrition for 90% or more of their nutritional needs and meeting the
        inclusion/ exclusion criteria.
Study to Assess the Efficacy and Safety of Levetiracetam for the Treatment of Social Anxiety Disorder (Generalized Type)
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 2

Summary: 
      Preclinical and clinical findings indicate that LEV has some anxiolytic potential. There is
      reason to believe that compounds with anxiolytic activity may have broad clinical utility
      across the anxiety spectrum. This trial was intended to explore LEV's utility in adults with
      social anxiety disorder.
    


Intervention name(s): levetiracetam
Intervention type(s): Drug
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Levetiracetam; Keppra
Sensorimotor Integration Exercises on Post-stroke Balance and Fall Efficacy
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      To study the effect of sensorimotor integration exercises on balance and fall efficacy in
      sub-acute stroke by performing 18 balance training exercises with three progressive steps.
    

Detailed description: 
      Balance impairment after stroke is significantly correlated with fall risk. To improve
      balance and reduce fall efficacy, the participants in the study group will be trained by six
      weeks three progressive steps of sensorimotor integration exercises. Each exercise step will
      take 30 minutes of a practice session, three sessions per week. Conventional physiotherapy
      (passive and active exercises and lower extremities strengthening exercises) will be given to
      the control group. The changes in balance performance and fall efficacy will be measured and
      compared within and between groups.
    

Intervention name(s): sensory motor integration exercises; conventional physiotherapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Sensorimotor integration exercises will be given in study group. The exercises will be performed in standing, sitting and walking. Exercises will be progressively increased from eye open to closed , floor to mat and head turns to right & left under the supervision of physiotherapist. Sensorimotor integration exercises will take 45 minutes in each session.; Conventional physiotherapy will take 30 minutes in each session, taking three sessions per weeks for six weeks. The exercises include simple lower extremity exercise and ambulatory training such as sit to stand, stepping, lateral and backward walking, and tandom walking etc.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Control Trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: sensory motor integration exercise
Climate Influence on Physiotherapy in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The aim of the study was to compare the effect of inpatient physiotherapy in a warm climate
      versus physiotherapy in a colder climate in multiple sclerosis (MS), in both short- and long
      term perspectives.
    

Detailed description: 
      Empirically, several patients with MS have reported improved function in warm climate during
      therapy or vacation. This is in contrast to the heat intolerance frequently reported in MS.
      Heat intolerance seems, however, to be individually distributed among the MS patients, and
      may seem to be related to the degree of warmth.

      Sixty patients with gait problems and without heat intolerance were included in a cross-over
      study. They were randomized to a 4-week inpatient physiotherapy based on the Bobath concept
      in Norway or Spain, with cross-over the year after. Data from five physical performance
      measures and six self-reported measures were collected at screening, baseline, after
      treatment and three and six months after both treatment-periods. Change over time within
      groups and comparisons of change between groups were analyzed by mixed models.
    

Intervention name(s): Physiotherapy
Intervention type(s): Other
Intervention description(s): Individual tailored physiotherapy according to the Bobath concept sixty minutes each working day for four weeks
Other intervention name(s): Physical Therapy; Subtropical climate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cross-over design; mixed model; multiple sclerosis; physical performance measures; physical therapy; the Bobath concept; warm climate; 6-minute walk test
Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy
Condition: Breast Cancer; Body Weight Changes
MeSH terms: Breast Neoplasms; Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      The study aims to test the feasibility and effects of a dietary and physical activity
      intervention based on evolutionary considerations in an oncological setting.
    

Detailed description: 
      A total of 13 breast cancer patients referred to our clinic for curative radiotherapy were
      recruited for this pilot study. The women were supposed to undertake a "Paleolithic
      lifestyle" (PL) intervention consisting of a Paleolithic diet and daily outdoor activity of
      at least 30 min duration while undergoing radiotherapy. Body composition was measured weekly
      by bioimpedance analysis. Blood parameters were assessed before, during, and at the end of
      radiotherapy. A control group on an unspecified standard diet (SD) was assigned by propensity
      score matching.
    

Intervention name(s): Curative radiotherapy; Paleolithic lifestyle intervention
Intervention type(s): Radiation; Other
Intervention description(s): Standard curative radiotherapy; This intervention consists of daily outdoor walks or bike rides of at least 30 min duration, preferably done at noon to maximize vitamin D production, and the adoption of a Paleolithic diet. For the outdoor activity, patients were told to not use sun screen. The Paleolithic diet prescription emphasized the consumption of fatty meats and organ meats from humanely raised animals, wild-caught fish, eggs, nuts and seeds, algae, spices, vegetables and fruits. Excluded were processed foods, grains of all types, legumes, vegetable oils except for native coconut and olive oil and dairy products except for ghee. No dietary supplements were allowed.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioimpedance analysis; Body composition; Nutrition; Oncology; Paleolithic diet
Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease, COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      Thirty-two subjects diagnosed with COPD were enrolled, received each study treatment and
      completed the follow-up assessments. During each of the four study periods, subjects were
      admitted to the clinic on Day -1 and housed overnight until after the last spirometry
      measurement. Serial pulmonary function tests were performed and PK (pharmacokinetics) samples
      collected up to 25 hours. Subjects were discharged from the clinic on Day 2 after
      evaluations.
    

Detailed description: 
      Subjects were assigned to one of the 4-treatment sequence groups presented in the table above
      according to a randomization schedule supplied by the Sponsor before study initiation. The
      randomization scheme did not include assignments for replacement subjects.

      Subjects reported to their respective clinical research unit (CRU) on Admission/Day -1 for
      pre-randomization procedures and confirmation of eligibility (and continued eligibility for
      Periods 2 to 4). The unblinded pharmacist prepared and dispensed the nebulizers, according to
      the randomization schedule for each of the 4 periods. Dosing occurred in the morning,
      generally between 7 am and 9 am. For Periods 2 to 4, dosing occurred within ±30 minutes of
      the dosing time established in Period 1.

      Study drug was administered in the respective CRU under the supervision of study personnel.
      Single doses of TD-4208, ipratropium bromide, and placebo were administered in the clinical
      research unit (CRU) under the supervision of study personnel. Care was taken to avoid eye
      contact with study drugs. Residual drug solution remaining in the nebulizer (ie, in mL) was
      measured and recorded.

      The investigator or designee was responsible for maintaining accountability records for all
      study drug(s) in accordance with applicable government regulations and study procedures.

      The accountability record included entries for receipt, distribution or dispensing, and
      destruction of the material(s). Unused and expired study drugs were to be disposed of in
      accordance with written instructions from the Sponsor.
    

Intervention name(s): Placebo; TD-4208 700 μg; TD-4208 350 μg; Ipratropium 500 μg
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Revefenacin; Revefenacin
Intervention MeSH terms: Ipratropium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease, COPD
Optimizing Meal and Snack Timing to Promote Health
Condition: Dietary Modification
Study type: Interventional

Summary: 
      This study will be conducted using standardized techniques to collect blood samples via an
      acute, randomized, cross-over design. Subjects will be provided all of their meals the day
      prior to testing and participate in 3 testing days with a minimum of 1 week break between
      testing days and a maximum time commitment of 7 weeks. A trained phlebotomist will place a
      catheter and collect blood samples from an antecubital vein using sterile techniques.
    


Intervention name(s): 10 + 20 g protein consumption; 30 g protein breakfast; 10 g protein breakfast
Intervention type(s): Dietary Supplement; Other; Other
Intervention description(s): whey isolate; 30 g mixed meal breakfast; 10 g mixed meal breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex
Condition: Facial Angiofibroma; Tuberous Sclerosis
MeSH terms: Tuberous Sclerosis; Angiofibroma; Sclerosis; Facies
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study aims to compare the safety and efficacy of two different strengths of Rapamycin
      cream, topical and placebo over 26 weeks in the treatment of facial angiofibroma (FA)
      associated with Tuberous Sclerosis Complex (TSC).
    

Detailed description: 
      Topical rapamycin has previously been used to treat FA associated with TSC, reducing
      erythema, papule size, while flattening lesions and improving skin texture. Topical rapamycin
      has been reported to be well tolerated.

      The efficacy and safety of a topical rapamycin cream at two strengths (0.5% and 1.0%) will be
      assessed during a 26 week double-blind treatment phase with assessments made at clinical
      visits at baseline, 2, 8, 14, 20 and 26 weeks, and at follow-up (4 weeks after the last dose
      of study drug).
    

Intervention name(s): rapamycin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Apply to the affected area once a day, approximately half an hour before retiring for bed in the evening, for 26 weeks; Apply to the affected area once a day, approximately half an hour before retiring for bed in the evening, for 26 weeks
Other intervention name(s): sirolimus
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treatment of Preschool Children With Upper Respiratory Tract Illnesses Using Azythromycin and Lower Respiratory Tract Symptoms Using Oral Corticosteroids.
Condition: Asthma; Wheezing
MeSH terms: Respiratory Sounds
Study type: Interventional
Phase: Phase 3

Summary: 
      This protocol is comprised of two separate, but linked, clinical trials for treating
      preschool-aged children with recurrent severe episodes of wheezing. The first study (APRIL)
      will try to prevent wheezing illness from developing using azithromycin. If a wheezing
      illness does occur, the second trial (OCELOT) will try to decrease the severity of symptoms
      using oral corticosteroids.
    

Detailed description: 
      Preschool aged children often have severe bouts of coughing and/or wheezing that lead to
      visits to the doctor's office, urgent care, emergency room and often hospitalization.
      APRIL-OCELOT is a randomized, double-blind, placebo controlled study in 600 preschool
      children with a history of significant wheezing episodes in the year prior to enrollment. All
      children enter the APRIL portion of the study, which will compare azithromycin to placebo,
      given for 5 days during the early signs of an upper respiratory tract illness, for preventing
      the development of lower respiratory tract symptoms. APRIL is a 78 week study, but
      participation will end earlier if the child requires a fourth course of APRIL treatment or
      develops significant lower respiratory tract symptoms. Only those children who develop
      significant lower respiratory tract symptoms during APRIL will enter the OCELOT portion of
      the study, which will compare oral corticosteroid to placebo for treating lower respiratory
      tract symptoms as measured by the Pediatric Respiratory Assessment Measure (PRAM). OCELOT
      participation will be complete after 14 days. Children may not reenter APRIL after completing
      OCELOT.
    

Intervention name(s): Azithromycin; Prednisolone; Placebo Azithromycin; Placebo Prednisolone
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day; Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day; Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day; Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day
Intervention MeSH terms: Azithromycin; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Wheezing; Respiratory Tract Illness; Azythromycin; Prednisolone; Preschool-age