bioihbjkbjnl/mcl2 huggingface dataset:
Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 3

Summary: 
      Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group
      1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular
      pertussis vaccine (DTaP), Group 2: 7-valent pneumococcal conjugate vaccine (7vPnC) and DTaP,
      Group 3: DTaP alone. Group 3 subjects will also receive catch-up doses of Prevenar
      (commercial product of Prevenar in Japan) 13vPnC and 7vPnC will be blinded, and DTaP will be
      open-label. The main purpose of the study is to determine if the immune responses to 13vPnC
      are comparable to the immune responses to 7vPnC and if the immune responses to 13vPnC given
      with DTaP are comparable to those induced by DTaP given alone. In addition, the study aims to
      evaluate the side effects (safety profile) after vaccination of 13vPnC and 7vPnC when given
      with DTaP in healthy Japanese infants.
    


Intervention name(s): 13-valent pneumococcal conjugate vaccine (13vPnC); diphtheria, tetanus, and acellular pertussis vaccine (DTaP); 7-valent pneumococcal conjugate vaccine (7vPnC); DTaP; DTaP
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL per dose, 4 doses; 0.5 mL per dose, 4 doses; 0.5 mL per dose, 4 doses; 0.5 mL per dose, 4 doses; 0.5 mL per dose, 4 doses
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: vaccine; pneumococcal conjugate
Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation
Condition: Skin Irritability
Study type: Observational

Summary: 
      Check the safety under normal conditions of use through the verification of emergence signs
      of irritability and sensitisation of the genital mucosa.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with age from 18 to 70 years old, with skin color varying between clear caucasian
        to dark.
Panitumumab in Children With Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study was to evaluate the safety and pharmacokinetics of up to
      3 different dose schedules of panitumumab in pediatric patients with solid tumors.
    

Detailed description: 
      This is an open-label, multi-center, single arm, dose-ranging, clinical study. Panitumumab
      will be administered by intravenous infusion to 4-6 patients per cohort. Three planned
      cohorts, stratified by age, will be studied at 100% of the recommended panitumumab dose for
      each treatment schedule as defined in adults. Enrollment will start with a 2.5 mg/kg once
      weekly administration to the 12 to < 18 year old patients. Upon demonstration of sufficient
      safety additional cohorts will open; a 2.5 mg/kg once weekly administration to the 1 to < 12
      year old patients and a 6.0 mg/kg once every two weeks to the 12 to < 18 year old patients.
      The decision to advance to the next cohort will be based on observance of ≤ 33% incidence of
      a dose limiting toxicity during the evaluation period. Subsequent cohorts of 6.0 mg/kg once
      every two weeks to the 1 to < 12 year old patients and 9.0 mg/kg once every three weeks to
      both age groups will open once sufficient safety in each cohort is determined. Participants
      may stay on study treatment until disease progression.
    

Intervention name(s): Panitumumab
Intervention type(s): Biological
Intervention description(s): Panitumumab administered by intravenous infusion
Other intervention name(s): Vectibix
Intervention MeSH terms: Panitumumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epidermal Growth Factor; Pediatric; Solid Tumors; Panitumumab; Dose Limiting Toxicity
IVF Clinical Trial of Two Different Treatment Protocols.
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to compare two different in vitro fertilization (IVF)
      treatments: conventional IVF protocol and minimal stimulation IVF protocol, in terms of
      success rates, stress of treatment, drug-related side effects, multiple pregnancies and cost
      of treatment.
    

Detailed description: 
      A random population of 564 sub-fertile women or couples with a female between ages of 18 and
      38 years and a desire to undergo their first IVF cycle will be included in this outpatient
      clinical trial. The participation in this study will be approximately six months with a total
      of 20 to 25 visits. After successful completion of the pre-screening tests participants are
      randomized into one of the two arms of the study: Arm A - mini IVF protocol, and Arm B -
      conventional IVF protocol.
    

Intervention name(s): in vitro fertilization (IVF/ICSI)
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVF Research Study; Infertility Sudy; in vitro fertilization; Mini IVF; Conventional IVF
Cohort Study of HIV-1 Incidence Among Clients of the Thai Red Cross AIDS Research Center, Bangkok, Thailand
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The purpose of this study is to assess populations in Thailand at high risk for HIV-1
      infection for potential efficacy trials of candidate HIV vaccines to include:

        1. assess incidence of HIV-1 and volunteer retention

        2. describe early viral load and CD4 counts

        3. assess participant willingness to participate in HIV vaccine efficacy trials and other
           HIV prevention trials

        4. describe volunteer risk behavior
    

Detailed description: 
      Prospective cohort study of HIV-negative participants who will receive voluntary counseling
      and testing (VCT) for HIV-antibody in conjunction with questionnaires on risk behavior,
      willingness to participate in HIV vaccine trials and other HIV prevention trials at 4 month
      intervals for a period of 1 year. This study will follow 1000 HIV-negative volunteers with an
      expected minimum of 15-20 incident HIV-infections based on a minimum incidence rate of
      1.5/100 person-years. Weighted incidence estimates will be calculated with exact 95%
      confidence intervals.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Population in Thailand who are seeking HIV counseling and testing at TRCARC
      
Biospecimen description: 
      Plasma, CD4, HIV-RNA
    
Keywords: HIV-negative; male and female clients; ages 18-50 years; seeking HIV counseling; testing at TRCARC
Study on Mechanisms of Changes in Liver Disease and Sex Steroid Metabolism During Weight Loss
Condition: Obesity
MeSH terms: Liver Diseases; Weight Loss
Study type: Observational

Summary: 
      The main objective of the study is to gain insight in the early dynamics and mechanisms of
      recovery of liver disease and sex steroid metabolism during weight loss in obese men and
      women and to investigate whether surgical weight loss has differential effects as compared to
      weight loss with life style measures. In addition, we want to evaluate the postprandial
      hypoglycemic reactive syndrome (PPHRS) in these patients using a standard chewable meal.

      Secondary objectives are investigating determinants for the changes in sex steroids, liver
      disease and PPHRS. Possible determinants to be investigated are adipocytokine secretion
      patterns, body composition, resting metabolism rate, weight loss per se and changes in fat
      distribution, parameters of fatty acid metabolism, … .
    


Intervention name(s): Gastric bypass surgery; Conservative weight loss program
Intervention type(s): Procedure; Behavioral
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with obesity class 3 who want to reduce weight
Study of Valproate in Young Patients Suffering From Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      Main objective: Therapeutic follow-up study Evaluate the clinical and biological safety of
      valproate administered as microgranules, under standard prescription conditions, with
      therapeutic follow-up and individual dosage adjustment, using valproate plasma concentrations
      and antiepileptic comedication as well as biological assays.

      Secondary objectives: Ancillary population kinetics study

        -  Estimate the pharmacokinetic parameters of valproate administered as microgranules under
           standard therapeutic conditions within the population studied, from the therapeutic
           follow-up data.

        -  Evaluate the influence of individual characteristics on the pharmacokinetic parameters.

        -  Describe the relationship between plasma concentrations and adverse events for valproate
           and the main anti-epileptic comedications.
    


Intervention name(s): valproate microgranules
Intervention type(s): Drug
Intervention description(s): 20 to 30 mg/kg/day
Intervention MeSH terms: Valproic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Percutaneous Needle Electrolysis (PNE) in Soleus Injury
Condition: Soleus Injury
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      This study evaluates if the physiotherapy treatment based on eccentric exercise,
      ultrasound-guided PNE or a combination of both therapies on chronic soleous injuries may
      cause changes in pain, functionality, dorsal flexion of the foot, balance and muscle fatigue
      in dancers.
    


Intervention name(s): Eccentric exercise; PNE; Combined
Intervention type(s): Other; Other; Other
Intervention description(s): soleus eccentric exercise; the application of galvanic current; soleus eccentric exercise and PNE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Open-label Study to Assess Immunogenicity and Safety of a Vaccine Enhancement Patch When Administered With 2 Doses of H5N1 Vaccine
Condition: Healthy
MeSH terms: Influenza in Birds
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Groups 1 to 3 will receive two vaccinations on Day 0 and Day 21. Group 1 will receive 3.8µg
      A/H5N1 antigen formulated with AS03 adjuvant, administered by IM injection. Group 2 will
      receive 15µg A/H5N1 by IM alone. Group 3 will also receive 15µg A/H5N1 antigen administered
      IM but followed by the topical application of a VEP at the vaccination site. Group 4 will
      receive a single vaccination on Day 0 of 30µg A/H5N1antigen by IM, followed by application of
      a VEP at the vaccination site.

      The VEP (Vaccine Enhancement Patch) contains 50 mcg LT (heat-labile enterotoxin of E. coli)
    


Intervention name(s): A/H5N1 Antigen; Vaccine Enhancement Patch
Intervention type(s): Biological; Drug
Intervention description(s): A/H5N1 Antigen; Vaccine Enhancement Patch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immunogenicity and Safety
The Pharmacokinetics of 12 Week Continuous Patch Use
Condition: Pharmacokinetics
Study type: Interventional

Summary: 
      Investigators propose a descriptive pharmacokinetic study of the serum hormone levels of
      estrogen and progesterone with extended use (12 weeks) of the contraceptive patch. The
      primary objective is to assess the change in serum ethinyl estradiol (EE2) levels over 12
      weeks of continuous contraceptive patch use. The secondary objective is assessing the the
      norelgestromin (NGMN) levels over the 12 weeks of continuous contraceptive patch use.
    

Detailed description: 
      For women who are seeking alternatives to long-acting contraceptives, the oral contraceptive
      pill and the contraceptive ring are often prescribed in an extended manner (12 weeks
      straight). The contraceptive patch, however, is not routinely prescribed in this way.
      Concerns have been raised that hormone levels, in particular estrogen, are higher among patch
      users than those who use oral contraception or the vaginal ring and that this may contribute
      to an increased risk of clot. However, few studies have actually looked at these hormone
      levels in women with extended use of the contraceptive patch.

      The investigators plan to enroll eligible women age 18-39 who are willing to use the
      contraceptive patch continuously for twelve weeks, and can adhere to the study requirements
      for follow-up. All participants will have weekly serum assessments of ethinyl estradiol and
      norelgestromin levels. The investigators will enroll 30 women, in anticipation of a 33%
      attrition rate, with the goal of obtaining completed data on 20 participants. The study
      duration for an individual participant will be 12 weeks and the duration of the entire study
      will be one year.
    

Intervention name(s): Xulane Contraceptive Patch
Intervention type(s): Device
Intervention description(s): Extended use (12 weeks) of contraceptive patch
Other intervention name(s): Ortho Evra®
Intervention MeSH terms: Contraceptive Agents; Ortho Evra
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hormonal contraception, hormone pharmacokinetics
A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis (GAMMA V)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objectives of this study are:

        1. To show a reduction in the late thrombosis (LT) rate following percutaneous
           revascularization using current interventional techniques with new stent placement and
           intravascular radiation therapy (IRT) with a long-term antiplatelet regimen (12 months)
           compared to the stented patients on short-term antiplatelet regimen (2 months) from the
           IRT arm of GAMMA I Trial.

        2. To show equivalence in the LT rate following percutaneous revascularization using
           current interventional techniques without new stent placement and IRT with a long-term
           antiplatelet regimen (6 months) compared to non-stented patients on short term
           antiplatelet therapy (2 months or less) from a pooling of the IRT arms of the GAMMA I,
           SCRIPPS, and WRIST Trials.
    


Intervention name(s): GAMMA-Iridium-192 catheter
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Negative Pressure Wound Therapy After Cesarean Delivery
Condition: Major Puerperal Infection, Postpartum; Wound Complications; Wound Seroma; Caesarean Section Wound Separation; Wound Infection
MeSH terms: Infections; Communicable Diseases; Wound Infection; Puerperal Infection; Seroma; Wounds and Injuries
Study type: Interventional

Summary: 
      This study is aimed at determining whether or not the use of a wound suction device placed on
      the cesarean incision instead of a standard sterile dressing will decrease the prevalence of
      wound complications and wound infections in women at high risk for post operative
      complications. The study will first look at the infection and wound complication rate in
      women 6 months prior to the start date of the study by reviewing charts of women who have
      undergone a cesarean section. The study involves placing a single use, portable wound vacuum
      over the cesarean section incision and keeping it in place for 72h. The investigators will
      then compare the rates of wound infection and wound complications between these two groups.

      It is our hypothesis that negative pressure wound systems will decrease the wound infection
      and complication rate in this high risk population.
    

Detailed description: 
      Infectious complications have been found to be five times higher in women undergoing a
      cesarean delivery compared to a vaginal delivery. Known risk factors for wound complications
      are obesity, premature rupture of membranes, diabetes mellitus, hypertensive disorders,
      emergency cesarean delivery, twin delivery, chorioamnionitis, increased surgical blood loss
      and preeclampsia.

      This study is aimed at determining whether or not the use of a suction device placed on the
      wound instead of a standard sterile dressing will decrease the prevalence of wound
      complications and wound infections in women at high risk for post operative complications.
      The investigators will compare the results from the participants of this study to an existing
      data set of historical controls who underwent cesarean delivery. The study involves placing a
      single use, portable negative wound pressure system kept in place while in the hospital after
      surgery (on average 48-72 hours) in women who meet criteria for increased risk of wound
      complications. The investigators will then compare the rates of wound infection and wound
      complications between these two groups.
    

Intervention name(s): Prevena negative pressure wound system
Intervention type(s): Device
Intervention description(s): Placement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cesarean delivery; Postpartum infection; Wound complications; Wound seroma; Wound separation; Wound infection; Negative pressure
Brain Imaging of Quetiapine Response in Anxious Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find out what parts of the brain have increased or decreased
      connectivity when people are depressed and how Seroquel extended release (XR) changes this
      connectivity in depressed patients. The genetic samples collected are to look at variation in
      a gene (serotonin transporter gene), which affects the functioning of the chemical serotonin
      in the brain.
    

Detailed description: 
      This study will measure the activity and connectivity in different parts of the brain, while
      the patients are seeing some pictures, using Magnetic Resonance Imaging (MRI) scan. For this
      study three MRI scans will be conducted. One before the patient begins on any medication, one
      during the study after 3 weeks of treatment and one after six more weeks of treatment with
      seroquel.
    

Intervention name(s): quetiapine (Seroquel XR)
Intervention type(s): Drug
Intervention description(s): Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
Other intervention name(s): Seroquel XR
Intervention MeSH terms: Quetiapine Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Anxiety; Seroquel; Quetiapine; fMRI; pictures
Detraining in People Living With HIV/AIDS
Condition: Lipodystrophy Syndrome, HIV; Sarcopenia
MeSH terms: HIV-Associated Lipodystrophy Syndrome; Sarcopenia; Lipodystrophy
Study type: Interventional

Summary: 
      The goal of this study was to evaluate the effect of detraining in the components of physical
      aptitude of people living with HIV/Aids (PVHA).
    

Detailed description: 
      The study was experimental with a sample composed by an Experimental Group (EG) with 11 PVHA,
      under antiretroviral therapy and a Control Group (CG) with 10 individuals without the
      infection; all which were under medical release and insufficiently active. The body
      composition was evaluated through the DXA, as well as the cardiorespiratory aptitude through
      the ergometer and the strength of the upper and lower limbs through dynamometry. Both groups
      conducted interventions with concurrent training for 15 weeks and the interruption of
      exercise was evaluated after a period of 5 weeks.
    

Intervention name(s): combined training
Intervention type(s): Other
Intervention description(s): Combined training consisting of aerobic and resisted training in the same training session for 15 weeks followed by 5 weeks of detraining
Intervention model: Sequential Assignment
Intervention model description: This is a longitudinal study of the non-randomized experimental type, presenting a non-probabilistic sample for convenience and independent groups. The sample consisted of 21 individuals divided into 2 groups: Experimental Group (EG) and Control Group (CG). The EG was composed of 11 people living with HIV/AIDS and CG composed of 10 people with no infection
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Detraining; Physical aptitude; HIV
The Effect of Hydrogen Rich Water Intake on Acute Body Response and Following Recovery After 5 km Run in Untrained Men
Condition: Athletic Performance; Muscle Fatigue; Oxidative Stress
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The aim of this randomized, double blinded, placebo controlled cross-over study is to
      evaluate the effect of hydrogen rich water intake on running performance, physiological and
      biochemical variables during endurance exercise and following recovery in endurance-untrained
      men.
    

Detailed description: 
      This study involves 16 endurance-untrained men aged 18-30 years. All participants drink
      hydrogen rich water (HRW) or placebo during the two days before the experiment (total volume
      2100 ml) and during the testing day (total volume 1680 ml). All participants undergo one
      laboratory session (entry diagnostic) and two experimental sessions in the field with a
      washout period of 7 days. In the two experimental sessions, participants receive HRW or
      placebo in a randomized order. Each experimental session consisted of a pre-exercise phase,
      an exercise phase (5 km run), and a 24 h passive recovery phase. The following variables are
      assessed: running times (5 km distance and 200 m laps), heart rate, rating of perceived
      exertion, blood lactate, reactive strength index, subjective perceived muscle soreness,
      protein carbonyl content, malondialdehyde content, heart rate variability. Statistical
      analysis is based on analysis of variance for repeated measures with the factors water (HRW
      and placebo), time, and interaction. Fisher´s post hoc tests is used for pairwise comparison.
      The significance level is set at 0.05.
    

Intervention name(s): Hydrogen rich water; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Hydrogen-rich water with molecular hydrogen concentration 0.9 ppm.; Tap water with molecular hydrogen concentration 0.0 ppm.
Other intervention name(s): Aquastamina-R, Nutristamina, Ostrava, Czech Republic; Aquastamina-Placebo, Nutristamina, Ostrava, Czech Republic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention