bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age
Condition: Diphtheria; Tetanus; Pertussis; Poliomyelitis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to provide further immunogenicity and safety information of
      sanofi pasteur's DTacP-IPV combined vaccine (TETRAXIM™) as a booster dose during the 4th and
      6th year of life in children that previously received in Study E2I34 (NCT 00255021), sanofi
      pasteur DTacP-IPV// PRP~T vaccine (PENTAXIM™) as a three-dose primary and booster
      vaccinations.

      Primary Objective :

        -  To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio
           types 1, 2 and 3) and seroconversion/vaccine response rates to acellular Pertussis
           antigens (Pertussis toxoid [PT], Filamentous Haemagglutinin [FHA]) of sanofi pasteur's
           DTacP-IPV (Tetraxim™) vaccine, one month after the booster dose given at 4 to 6 years of
           age.

      Secondary Objectives :

        -  To describe the antibody persistence in terms of anti-pertussis antibody levels
           (anti-PT, and -FHA) and in terms of seroprotection rates and GMTs for Diphtheria,
           Tetanus, and Poliovirus types 1, 2 and 3, just before administration of the booster dose
           (at Visit 1) in all subjects at 4-6 years of age.

        -  To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio
           types 1, 2 and 3) and seroconversion/ vaccine response rates to acellular Pertussis
           antigens (PT, FHA) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after
           administration of the booster dose given at 4 to 6 years of age.

        -  To describe the safety after the booster dose of the study vaccine.
    

Detailed description: 
      All participants that previously completed the three-dose primary and the booster
      vaccinations in the study E2I34 (NCT 00255021) will be contacted to enroll in this study to
      receive sanofi pasteur's DTacP IPV combined vaccine (Tetraxim™) at 4 to 6 years of age.

      Participants will receive the study vaccine [sanofi pasteur's DTacP-IPV vaccine (TETRAXIM™)]
      at 4 to 6 years of age (at visit 1).
    

Intervention name(s): DTacP-IPV combined vaccine (TETRAXIM™)
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Other intervention name(s): TETRAXIM™
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Poliomyelitis; PENTAXIM™; TETRAXIM™
Factors Associated With Residual Disease In The Central Cone
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Uterine Cervical Dysplasia
Study type: Observational

Summary: 
      Cervical conization using the loop electrosurgical excision procedure (LEEP) is the standard
      treatment for patients with high-grade cervical intraepithelial neoplasia. Several studies
      have shown that excising a central cone reduces the rate of positive endocervical margins.
      The purpose of this study is to identify clinicopathological factors associated with residual
      disease in the central cone and to develop a predictive model to better determine which
      patients may require this additional procedure.
    

Detailed description: 
      This study pretends to create a retrospective database including all patient who underwent a
      loop electrosurgical excision procedure by treatment for high-grade cervical intraepithelial
      neoplasia and create a a predictive model for top-hat resection in patients with high grade
      CIN
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients who underwent a cervical cone procedure at the Dysplasia Clinic of the Instituto
        Nacional de Cancerologia in Mexico City
      
Keywords: residual disease; central cone; predictive model
Single Rising Dose Study of BI 135585 XX in Health Asian Male Volunteers.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and
      pharmacodynamics in Asian healthy males administered a single dose of BI 135585.
    


Intervention name(s): Matching placebo; BI 135585 XX
Intervention type(s): Drug; Drug
Intervention description(s): single dose of matching placebo; single dose of low, medium or high dose of BI 135585 XX
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Post-Marketing Surveillance Study of Adalimumab in Pediatric Chronic Severe Plaque Psoriasis Patients in Korea
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      The objective of this study is to evaluate the real world safety and effectiveness of
      adalimumab (Humira) for the treatment of Korean patients with pediatric chronic severe plaque
      psoriasis under a routine treatment practice.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric participants with chronic severe plaque psoriasis
      
Keywords: Post-marketing; Adalimumab; Humira; Pediatric; Chronic severe plaque psoriasis; Psoriasis
Promoting Self-Regulation Skills and Healthy Eating Habits in Early Head Start
Condition: Poverty
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness of a new curriculum on toddlers'
      self-regulation skills and healthy eating habits. The curriculum is being delivered as part
      of Early Head Start home visits and compared to the effectiveness of usual practice Early
      Head Start home visits.
    


Intervention name(s): Recipe 4 Success; Usual practice Early Head Start
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Home visitors teach parents about children's self-regulation skills and healthy eating habits. The home visitors then teach parents how to sensitively scaffold the development of their toddlers' self-regulation skills in the context of cooking and snack preparation lessons. Prior research shows that self-regulation skills in early childhood predict long-term health indicators, such as BMI. Prior research also shows that children who are involved in the preparation of healthier foods are more likely to eat them.; Home visitors will continue to deliver usual practice Early Head Start home visits that follow a standard curriculum and are tailored on an ongoing basis to meet individual family needs.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Families are blocked within home visitor caseload and randomly assigned to receive the new curriculum or usual practice Early Head Start home visits for 12 weeks.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency
Condition: Intestinal Insufficiency; Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome
Study type: Observational

Summary: 
      Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with
      significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition
      as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and
      symptom-relieving agents may be required. Prescriptional pattern of these drugs will be
      analyzed in a clinical cohort.
    

Detailed description: 
      Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with
      significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition
      as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and
      symptom-relieving agents may be required. Little attention has been given to the indications
      and dosage schedules of such drugs, many of which are employed as off-label prescriptions
      because of lack of official guidelines.

      Prescriptional patterns of these drugs will be analyzed in a clinical cohort of home
      parenteral/enteral nutrition patients, registered at the outpatient service of Hospital das
      Clinicas, Sao Paulo, Brazil.
    

Intervention name(s): Drug prescription pattern
Intervention type(s): Drug
Intervention description(s): Type, dosage, administration route and frequency of prescription of all adjuvant pharmacologic agents will be transcribed from hospital records
Other intervention name(s): Gastrointestinal drugs; Antibiotics; Vitamins; Minerals; General drugs
Intervention MeSH terms: Anti-Bacterial Agents; Gastrointestinal Agents
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with short bowel syndrome secondary to trauma, Crohn´s disease, mesenteric
        thrombosis, radiation enteritis and other conditions, suffering from intestinal
        insufficiency and undergoing home-parenteral or enteral nutrition.
      
Keywords: Gastrointestinal drugs; Antibiotics; Vitamins; Minerals; Intestinal insufficiency; Short Bowel syndrome; Adjuvant therapy; Antacids; Gastrointestinal motility modifiers; Micronutrients
Fit Plus: Assessing the Impact of a School-based Intervention on Toilet Quality
Condition: Hand Hygiene
Study type: Interventional

Summary: 
      This study will assess the impact of a school-based water, sanitation, and hygiene management
      intervention on toilet use and pupil handwashing in the Philippines.
    


Intervention name(s): FIT Plus; Comparator arm
Intervention type(s): Other; Other
Intervention description(s): Group handwashing facilities
Daily group handwashing and toothbrushing activities
Sanitation operation and maintenance manuals for school officials
Toilet cleaning consumable
Toilet and handwashing station maintenance kits
Soap, toothbrushes, and toothpaste; This is the same intervention as FIT Plus, but will be delivered to schools following endline data collection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
a Study to Evaluate the Pharmacokinetics and Safety of TPN171H Tablets in Patients With Renal Insufficiency and Healthy Subjects
Condition: Pulmonary Arterial Hypertension; Erectile Dysfunction
MeSH terms: Pulmonary Arterial Hypertension; Erectile Dysfunction; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of renal insufficiency on the pharmacokinetics of TPN171H tablets
      after single dose oral administration, so as to provide basis for formulating clinical
      medication plan for patients with renal insufficiency; To evaluate the safety of TPN171H
      tablets in patients with renal insufficiency and healthy subjects
    

Detailed description: 
      The study design of two centers, parallel, open and single dose administration is adopted.
      The experiment is carried out in two stages, whether or not to start the second stage is
      according to the test results of the first stage.

      The first stage: there are two groups: severe renal insufficiency group and healthy subjects
      group. 8 subjects in each group (both male and female), a total of 16 cases.

      The second stage: part A or part B. Part A: there are two groups: non dialysis end-stage
      renal disease (ESRD) group, with 8 subjects (both men and women), in the group with healthy
      subjects , there are 0-8 subjects.

      Part B: there are three groups: mild renal insufficiency, moderate renal insufficiency and
      healthy subjects. There are 8 subjects (both male and female) in both mild renal
      insufficiency group and moderate renal insufficiency group, and 0-8 subjects (both male and
      female) in the healthy subjects group.

      The initiation criteria of second stage study are: if auc0-t of subjects with severe renal
      insufficiency in the first stage is less than twice that of subjects with healthy subjects,
      And expected in the end of nephropathy If there is no significant increase in safety risk
      among (non dialysis) subjects, it is decided to start the second stage part A study instead
      of the second stage part B study according to the results of the first stage; if the auc0-t
      of subjects with severe renal insufficiency in the first stage is more than twice that of
      subjects with healthy subjects, it is decided whether to start the second stage part B study
      instead of the second stage part A study according to the results of the first stage.
    

Intervention name(s): TPN171H single dose
Intervention type(s): Drug
Intervention description(s): 10 mg TPN171H taken once
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TPN171H; renal insufficiency; Pharmacokinetics
Glucose Clamp Study to Prove Hypo- and Hyperglycemic Episodes Using a Non-invasive Glucose Monitoring Device
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Continuous monitoring of the skin tissue glucose concentration on two different study days
      using glucose sensors that work on the principle of impedance spectroscopy, with systematic
      alteration of the blood glucose concentration using the glucose clamp technique in healthy
      subjects and subjects with type 1 diabetes. Simultaneous determination of electrolyte
      concentrations in the blood by taking frequent blood samples.
    

Detailed description: 
      A completely non-invasive continuous glucose monitoring device is considered as a major
      target of glucose sensor development. The aim of this study is to evaluate the performance of
      a non-invasive glucose sensor (wristwatch) under controlled conditions (glucose clamp) at
      hyperglycemia (study day 1) and at hypoglycemia (study day 2). Measurements of the
      non-invasive glucose monitoring device are compared to those obtained from a minimally
      invasive glucose monitoring device (GlucoDay, microdialysis principle). In addition, changes
      in blood electrolyte concentrations as well as their impact on the measurements of the
      non-invasive glucose sensor are evaluated.
    

Intervention name(s): Non-invasive CGMS (continuous glucose monitoring system); Hyperglycemic and hypoglycemic glucose clamp; Non-invasive CGMS (GlucoDay)
Intervention type(s): Device; Procedure; Device
Intervention description(s): A non-invasive continuous glucose monitoring device measure was applied at the wrist and measure skin glucose as an indirect measure of blood glucose every 10 min.; The automated glucose clamp technique was used to control glucose levels at baseline glycemia for 1h, hyperglycemia (300 mg/dL) for 1.5 h, and euglycemia (100 mg/dL) for another 1.5 h. A continuous somatostatin infusion was initiated after the 2 h run-in period to suppress endogenous insulin secretion. A glucose solution was infused to increase blood glucose towards the hyperglycemic target level. At the end of the hyperglycemic level the somatostatin infusion was stopped and blood glucose was controlled at the euglycemic target level. On a second study day a hypoglycemic clamp took place, where blood glucose after the run-in period of 2 h was lowered by means of intravenous insulin administration over a period of appr. 30 min to a hypoglycemic level of 45 mg/dL, where it was kept constant for appr. 30 min, after which blood glucose was raised to euglycemia (100 mg/dL) again by means of an intravenous glucose infusion and was kept there for 1.5 hours. .; The minimally-invasive glucose sensor GlucoDay, was used as a control measure
Intervention MeSH terms: Hypoglycemic Agents
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes
Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)
Condition: Varicella
MeSH terms: Chickenpox
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX® (Varicella
      Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with
      the VARIVAX® 2016 commercial process. The primary hypotheses being tested are that antibody
      response rate and mean antibody titer induced at 6 weeks after a single vaccination by
      VARIVAX® PE34 Process are non-inferior to those induced by VARIVAX® 2016 commercial process,
      and that antibody response rate induced by VARIVAX® PE34 Process is acceptable.
    


Intervention name(s): VARIVAX® PE34 Process; VARIVAX® 2016 Commercial Process; M-M-R II®
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Varicella virus vaccine live manufactured with a new passage extension process (PE34); Varicella virus vaccine live manufactured with the 2016 commercial process; Measles, Mumps, and Rubella virus vaccine live
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine safety and efficacy of long-cycle regimens of an
      oral contraceptive.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG (BSP AG), Germany.

      Bayer Schering Pharma AG, Germany is the sponsor of the trial.

      The previously posted secondary Outcome Measure "Parameters of safety and tolerability" has
      been removed from result posting as it is covered by the Adverse Event section.
    

Intervention name(s): Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300); Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300); Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.; 3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.; 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
Intervention MeSH terms: Drospirenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of Anti-mullerian Hormone Levels as Predictive of IVF Outcomes in Women Over 38 Years Old
Condition: AMH Levels; Inhibin B Levels; IVF Patients Over 38 Years Old
Study type: Observational

Summary: 
      The present study is designed to evaluate the basal serum levels of anti-mullerian hormone
      (AMH) and inhibin B as early predictors of ovarian response, implantation rate, and pregnancy
      rate in women 38 years old or older that are undergoing an IVF cycle.
    

Detailed description: 
      Specifics aims are: a) to describe AMH and inhibin levels on day 3 previous to ART cycle; b)
      to analyze the association between these hormone levels and the retrieved metaphase II
      oocytes quantity; c) to analyze the association between these hormone levels and quality
      embryo score d) to analyze the association between these hormone levels and the number of
      gestational sacs per transferred-embryo (implantation rate); e) to analyze the association
      between these hormone levels and the pregnancy rate; f) to make a prediction model for
      pregnancy rate by using a multivariable regression analysis.

      Patient participation includes signing the consent and having additional tubes of blood drawn
      at a regularly scheduled blood draw. This blood is used to run the study tests (AMH and
      inhibin levels).
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women undergoing IVF treatment who are over the age of 38 years.
      
Biospecimen description: 
      serum
    
Keywords: AMH; inhibin B; infertility
Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Therapy Using 1,064 nm and 595 nm
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional

Summary: 
      This is a prospective, multi-center, split-face, controlled clinical trial that aims to
      investigate the efficacy and safety of picosecond, neodymium-doped yttrium aluminum garnet
      laser laser therapy on patients with melasma, compared with 2% hydroquinone cream. The trial
      will be performed by two Korean institutions on 45 subjects.
    


Intervention name(s): PICO+4; Neoquine Cream 2%
Intervention type(s): Device; Drug
Intervention description(s): picosecond, neodymium-doped yttrium aluminum garnet laser; 2% hydroquinone cream
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      -  The purpose of this study is to describe the safety of the study vaccine (called 13vPnC)
           in people who are 18-49 years of age in India.

        -  This study is seeking participants who are generally healthy adults ≥18 and <50 years of
           age, with no prior history of pneumococcal vaccination.

        -  Participants will take part in the study for approximately one month which includes two
           visits to the study clinic.

        -  Participants will receive a single dose of study vaccine (13vPnC) into the arm at visit
           1 and will come to study site for a follow-up visit after about a month.
    


Intervention name(s): 13-valent pneumococcal conjugate vaccine
Intervention type(s): Biological
Intervention description(s): One dose of 13vPnC (0.5mL) will be administered intramuscularly.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention