bioihbjkbjnl/mcl2 huggingface dataset:
Chlamydia Trachomatis Immunology and Vaccinology Study
Condition: Chlamydia
MeSH terms: Chlamydia Infections
Study type: Observational

Summary: 
      The primary objective is to prospectively follow 200 women with or at risk of cervicitis to
      determine the chlamydia-specific cellular responses that correlate with protection against
      incident infection. The hypothesis is that a positive IFN-y response by peripheral CD4+ T
      cells responding to stimulation with HSP60 will be significantly associated with protection
      from incident C. trachomatis infection.
    

Detailed description: 
      A total of 200 women with or at high risk of having cervicitis will be prospectively followed
      for correlations between chlamydia-specific cellular responses and protection against
      incident infection.

      At enrollment participants will undergo a history and physical examination; blood draw; and
      pelvic examination including collection of vaginal and cervical samples, STD testing and
      endometrial biopsy.

      Participants will have follow up visits conducted at 1, 4, 8 and 12 months following
      enrollment. At the follow-up visits, participants will undergo a repeat history and physical,
      blood draw and pelvic examination including collection of vaginal and cervical samples and
      STD testing.

      The study design will allow comprehensive identification of the antigen-specific cell
      mediated immune responses most strongly associated with protection against C. trachomatis
      infection.

      The primary objective is to prospectively follow 200 women with or at risk for cervicitis to
      determine the chlamydia-specific cellular responses that correlate with protection against
      incident infection.
    

Intervention name(s): ceftriaxone; Azithromycin
Intervention type(s): Drug; Drug
Intervention description(s): 250mg IM once; 1 gm once
Intervention MeSH terms: Azithromycin; Ceftriaxone
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women positive for chlamydia or at high risk of chlamydia infection.
Healthy Lifestyle Behavior Intervention for Latino Women
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The overall goal of this randomized controlled trial is to evaluate the effects of a
      community-based lifestyle behavior intervention (LSBI) that is designed to improve dietary
      habits and physical activity (PA), and reduce weight of Latino women who are predominantly
      Spanish-speaking immigrants. It is hypothesized that middle-aged overweight/obese Latinas
      participating in a LSBI conducted by lay health advisors will demonstrate improved dietary
      habits, increased physical activity and a decrease in BMI compared to those in a control
      condition, Women in the LSBI also are expected to demonstrate improvements in selected
      physiologic outcomes (waist circumference, blood pressure [BP], measures of cholesterol and
      blood sugar).
    

Detailed description: 
      Overweight/obesity and physical inactivity are two significant predictors of illness and
      death from cardiovascular (heart) disease (CVD) in Latina adults. These risk factors may be
      reduced or eliminated through prevention efforts that focus on heart-healthy diets, weight
      reduction, and PA. The purpose of this study is to compare the effects of a 6-month
      community-based lifestyle behavior intervention (LSBI) conducted by lay health advisors and a
      control condition (disaster preparedness and home safety program) on lifestyle behaviors
      -dietary habits and physical activity(primary outcome) and selected physiologic outcomes
      (secondary outcomes) i.e., BMI, waist circumference, blood pressure, measures of
      cholesterol,and fasting blood sugar of Latinas who are overweight/obese. The LSBI includes
      group education (8 classes) and individual teaching and coaching (8 contacts by home visits
      and telephone calls) delivered over a 6-month period. Acceptability and feasibility of the
      intervention is evaluated through examination of women's retention rates and participation in
      classes and home visits.
    

Intervention name(s): Lifestyle behavior interventon grop; Placebo Comparator: Control group
Intervention type(s): Behavioral; Other
Other intervention name(s): Disaster Preparedness/Home Safety
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hispanic/Latina Americans; Cardiovascular diseases; Obesity; Intervention
Effect Of Using Oxygen On The Diaper Dermatitis In Infants
Condition: Diaper Rash; Diaper Dermatitis
MeSH terms: Dermatitis; Diaper Rash
Study type: Interventional

Summary: 
      Background: Airing the diaper area has a positive effect on dermatitis. In addition, it is
      reported in the literature that oxygen is effective in wound care. The aim of our study is to
      investigate the effect of oxygen on infant diaper dermatitis.

      Method: The study population consisted of infants will admit to the neonatal intensive care
      unit of a public hospital in Istanbul between October 2022 and April 2023. Sixty newborns who
      met the study criteria will randomly divide into two as the experimental (n=30) and control
      (n=30) groups. Personal data form and diaper dermatitis observation form will be used to
      obtain the data. All babies' diapers will be changed 8 times a day. Oxygen flow will be
      applied to the experimental group for one hour after each diaper change. The degree of diaper
      dermatitis will be evaluated every 24 hours.
    


Intervention name(s): Oxygen
Intervention type(s): Drug
Intervention description(s): After changing the diaper, free flow oxygen will be provided to the diaper area for 1 hour with an oxygen cannula placed inside the diaper (oxygen flow is %21 Fio2, 5 L/min)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: infant; diaper dermatitis; diaper rash; oxygen
Immunogenicity and Safety of BoostrixTM Using a New Syringe in 10 to 15-year Old Adolescents
Condition: Diphtheria; Tetanus; Acellular Pertussis
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the immunogenicity and safety of a booster dose of
      BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in
      the previous syringe presentation in healthy adolescents aged 10-15 years.
    

Detailed description: 
      The protocol has been updated following Protocol amendment 1 date 03 August 2011 leading to
      the update of the exclusion criteria to allow subjects in Mexico to receive the flu vaccine
      in accordance with the local standard of care.

      The protocol has been updated following Protocol amendment 2 dated 14 December 2011 due to
      the recruitment constraints as a result of the DT/dTpa vaccination campaign in the countries.
      The inclusion and exclusion criteria were amended to allow the participation of those who
      have already received the 6th dose of the diphtheria, tetanus and/or pertussis containing
      vaccine.
    

Intervention name(s): Boostrix TM (new syringe presentation); Boostrix TM (previous syringe presentation)
Intervention type(s): Biological; Biological
Intervention description(s): Single dose, intramuscular administration in a new syringe presentation; Single dose, intramuscular administration in previous syringe presentation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: dTpa; Boostrix
Morphological and Functional Effects of a Foot Strengthening Protocol
Condition: Foot Strength Deficit
Study type: Interventional

Summary: 
      The principal aim of this study is to investigate the effects of a four-week foot
      strenghtening protocol combining active voluntary exercises and assisted-active voluntary
      exercises by neuromuscular electrical stimulation on hallux toe flexion strength in
      comparison to a standard foot strengthening protocol in a healthy adult recreational active
      population.

      The secondary objectives of the study are to investigate the effects of this protocol on
      lesser toes flexor strength, foot morphology deformation in one, two and three dimensions and
      kinetic parameters when walking and running.
    


Intervention name(s): La Tour Hospital Foot Strengthening Protocol; Standard Literature Foot Strengthening Protocol
Intervention type(s): Procedure; Procedure
Intervention description(s): First exercise : "NMES forward lean doming". Doming exercise assisted by NMES placed on the IFM. 8 sec of contraction (6 sec rest) moving the trunk forward. 12 repetitions, 3 sets. Progressive increase of the intensity of NEMS during 4 weeks and increase of body load while decreasing the number of repetitions.
Second exercise : "MTP joint flexion". Isometric MTP joint flexion contractions. 4 contractions of 5 sec (10 sec rest), 3 sets. Progressive increase of the number of MVIC during 4 weeks and of increase body load while keeping the same intensity.
Third exercise : "Foot-ankle rebound". Multiple jumps with only plantar flexion. Keeping the knee stiff and straight and pushing off the ground with only ankle and MTP plantar flexion by a forefoot contact with the ground. 10 seconds of jump (1 min of rest) during 5 sets. Progressive increase of body load while keeping the same intensity.; During the 1st week, the participants will perform the "Short foot exercise" (SFE) during 3 series of 10 repetitions of 5 seconds of contractions in sitting position. 1 minute of rest will be give between series.
During the 2nd week, the participants will perform the SFE during 3 series of 15 repetitions of 5 seconds of contractions in sitting position. 1 minute of rest will be give between series.
During the 3rd week, the participants will perform the SFE during 3 series of 15 repetitions of 5 seconds of contractions in standing bipedal position. 1 minute of rest will be give between series.
During the 4th week, the participants will perform the SFE during 3 series of 15 repetitions of 5 seconds of contractions in standing unipedal position. 1 minute of rest will be give between series.
The progression of the exercise during the protocol will be based on passing from a sitting position to a unipedal standing position.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Drug Drug Interaction of Empagliflozin (BI 10773) and Warfarin in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study is to investigate the bioavailability of BI 10773 and of
      warfarin after concomitant multiple oral administration of BI 10773 and a single oral dose of
      warfarin in comparison to BI 10773 and warfarin given alone, and to investigate the
      pharmacodynamics of a single oral dose of warfarin with and without concomitant multiple oral
      administration of BI 10773.
    


Intervention name(s): BI 10773 25 mg; Warfarin 25 mg; BI 10773 25 mg; Warfarin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 25 mg BI 10773 qd for 5 days; 25 mg Warfarin single dose; 25 mg BI 10773 qd for 12 days; 25 mg warfarin single dose with and without 50 mg BI 10773
Intervention MeSH terms: Empagliflozin; Warfarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of a Multi-strain Probiotic in the Treatment of Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome; Digestive System Diseases; Colonic Diseases, Functional; Colitis, Mucous; Colon, Irritable
MeSH terms: Irritable Bowel Syndrome; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The Canadian College of Naturopathic Medicine is conducting a research study on Irritable
      Bowel Syndrome (IBS), a common condition in North America. It is a long term, recurring
      gastrointestinal disorder that is estimated to affect 30% of the general population. IBS is
      characterized by abdominal pain and cramps, and bowel dysfunction such as diarrhea and
      bloating.

      The medicines that are currently used to help people with IBS are not as effective as we
      would like them to be. These medicines are usually only prescribed to reduce the pain of IBS
      and not actually treat the disorder itself. Recently, scientists have found that probiotics
      (beneficial bacteria that live inside humans) may help reduce the painful symptoms and
      diarrhea that are part of IBS.

      This research is being conducted to determine whether this particular combination of three
      probiotic bacteria (named Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium
      longum) will reduce the symptoms of severe IBS.
    

Detailed description: 
      The purpose of this trial is to investigate the effects of the three strain probiotic,
      Kyo-Dophilus, on the symptoms associated with severe Irritable Bowel Syndrome. A previous
      pilot clinical trial identified individuals with severe IBS to be most likely to benefit from
      the treatment provided in this trial.

      The primary objective of this trial is to determine the effectiveness of Kyo-Dophilus on the
      symptoms associated with Irritable Bowel Syndrome in an adult population diagnosed with
      Irritable Bowel Syndrome by ROME III criteria and classified as severe through the Irritable
      Bowel Severity Scoring System and to measure quality of life and global well-being of
      patients through the Adequate Relief Criteria and the Irritable Bowel Syndrome-Quality of
      Life Questionnaire.

      The secondary objective is to assess the tolerability of the treatment through the use of
      Adverse Event Reporting Forms.
    

Intervention name(s): Kyodophilus multi-strain probiotic capsules; Kyodophilus Matching Placebo Capsules
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bloating; constipation; diarrhea; gas; mucous; cramping
Non-integrated Costs Increase Effectiveness of Incentives
Condition: Control - No Incentive for Flu Vaccine; Direct Incentive; Indirect Incentive
Study type: Interventional

Summary: 
      The investigators will test the hypothesis that the control (no incentive) condition will
      have the lowest vaccination rate, the main task condition will have a significantly higher
      vaccination rate while the indirect condition will have the highest vaccination rate.

      Participants will be randomly assigned to one of the three message conditions and their
      vaccination records obtained from the university Occupational Health Department.
    

Detailed description: 
      The investigators will send e-mails to a complete mailing list of faculty and staff at a
      university. Each recipient will be randomly assigned to one of three conditions: control,
      main task incentive or indirect incentive. Our main dependent variable will be whether or not
      participants decide to get vaccinated. The investigators will obtain their actual vaccination
      records from the university Occupational Health Department.

      Within the e-mail message, participants will indicate whether or not they intend to get
      vaccinated. Intention serves as an indirect dependent outcome. Upon clicking to indicate
      their intention, participants are redirected to a page which gives further instructions on
      how to proceed.

      Participants who vaccinate will be asked to complete a brief follow-up questionnaire to
      evaluate their experience with vaccination and (for those offered and incentive) to provide
      contact information to receive their payment.
    

Intervention name(s): Email Message; Incentive for Vaccination; Incentive for completing a short survey
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will randomly receive an e-mail message about the availability of free flu vaccines.; $5 gift card offered for vaccination; $5 gift card offered for completing s short survey after one gets vaccinated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: incentives; field study; vaccination
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Spain
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is a Spanish, Multicentre, Observational Study to study adherence and long term outcomes
      of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone
      treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter, longitudinal observational study.
      Parents/subjects will provide their Informed Consent/assent to upload their data for
      population-based analyses and, ultimately, clinical outcomes. Adherence data will be
      primarily derived from the easypod™ device combined with physician data entry of outcome
      measures. Data will be collected retrospectively and prospectively. This will allow the
      establishment of adherence profiles and subsequent clinical outcomes. Collected data will be
      also analyzed in a multinational pooled analysis of comparable national studies.

      Primary Objective:

      - To assess the level of adherence of subjects receiving SAIZEN® via easypod™

      Secondary Objectives:

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
           via easypod™

        -  To identify adherence subject profiling

        -  To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above,
           below or within normal ranges)
    

Intervention name(s): easypod™
Intervention type(s): Device
Intervention description(s): Saizen (Somatotropin) as per Summary of Product Characteristics (SmPC) administered by easypod™
Other intervention name(s): Somatotropin
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        easypod™ electromechanical device.
      
Keywords: Growth disorders; Saizen; Easypod; Growth hormone; Pediatric subject
Zoladex Plus Tamoxifen in Breast Cancer
Condition: Mammography; Estrogen; Lipemia; Endometrium; Ultrasonography
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      The purpose of this study is to compare Zoladex plus tamoxifen with tamoxifen alone as
      adjuvant hormonal therapy in pre- or perimenopausal women with early-stage breast cancer in
      terms of breast density, estrogen levels, lipidemia, endometrial thickness and
      ultrasonographic abnormalities.
    

Detailed description: 
      After the completion of primary treatment(surgery and/or adjuvant chemotherapy, radiotherapy
      could be given concurrently with study medication), eligible patients will be randomized to
      receive Zoladex plus tamoxifen or tamoxifen alone. The duration of study medication along
      with the follow-up will be 18 months, or until disease recurrence,or discontinuation of study
      therapy (as a result of an adverse event, a patient's request, or an investigator's
      decision), further treatment will be at investigator's discretion.

      During the study period, contralateral mammograms and transvaginal ultrasound will be
      undertaken at baseline and after 6, 12 and 18 months of study medications. Mammographic
      density assessment will be undertaken by a single radiologist. Serum measurements including
      estrogen levels and lipidemia will be obtained at baseline and after 3, 6, 12 and 18 months
      of study medications.
    

Intervention name(s): tamoxifen; Goserelin
Intervention type(s): Drug; Drug
Intervention description(s): In the monotherapy arm, patients receive once-daily oral dose of tamoxifen 20 mg.; In the combination arm, patients receive ZOLADEX 3.6 mg by subcutaneous injection every 4 weeks along with once-daily oral dose of tamoxifen 20 mg
Other intervention name(s): TAM; ZOLADEX
Intervention MeSH terms: Tamoxifen; Goserelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast carcinoma; goserelin; Mammographic density
The Study of AZD8529 for Smoking Cessation in Female Smokers
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy and safety of AZD8529 for smoking cessation in female smokers.
    

Detailed description: 
      This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of
      two different doses of AZD8529 (1.5 and 40 mg) in smoking cessation. Up to 2 weeks will be
      allowed for the Screening Period, followed by a 1-week, single-blind run-in period. At the
      end of Study Week 1 (on Study Day 8), medication compliance will be one of the factors used
      in a predictive enrichment strategy.
    

Intervention name(s): AZD8529
Intervention type(s): Drug
Intervention description(s): comparison of different dosages of drug
Other intervention name(s): AZD-8529
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: smoking; smoking cessation; cigarette
Safety and Efficacy of TULY (Rasburicase) in Prevention and Treatment of Malignancy-associated Hyperuricemia
Condition: Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a prospective, open-label, multicentre study. Hundred eligible patients with
      stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL) with a
      peripheral white blood cell (WBC) count of > 25,000/µL or any leukemia or lymphoma with
      plasma uric acid level of at least 8 mg/dL will be treated with rasburicase 0.20 mg/kg body
      weight intravenously for 4 days. The primary endpoints viz., the percentage of reduction in
      plasma uric acid at 4 hrs after uric acid-lowering therapy, plasma uric acid AUC 0-96 hr and
      incidence of adverse events will be assessed during 11 days study period.
    

Detailed description: 
      All eligible patients will be treated with rasburicase 0.20 mg/kg body weight intravenously
      for 4 days. The primary endpoints viz., the percentage of reduction in plasma uric acid at 4
      hrs after uric acid-lowering therapy, plasma uric acid AUC 0-96 hr and incidence of adverse
      events will be assessed during 11 days study period.
    

Intervention name(s): TULY
Intervention type(s): Drug
Intervention description(s): TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention