bioihbjkbjnl/mcl2 huggingface dataset:
Seroprevalence Study to Evaluate the Persistence of Anti-leptospira Antibody in Subjects Vaccinated With Spirolept® Vaccine
Condition: Leptospirosis
MeSH terms: Leptospirosis; Weil Disease
Study type: Observational

Summary: 
      The study aims to assess antibody persistence induced by Spirolept® vaccination in subjects
      who received at least 4 doses (2 doses two weeks apart and 2 booster doses) and no more than
      a total of 8 doses (2 doses two weeks apart and 6 booster doses).
    

Detailed description: 
      This is a seroprevalence, phase IV, multi -center study to evaluate anti-Leptospira antibody
      persistence in subjects who have received at least the 2nd booster (4 vaccine doses) and no
      more than the 6th booster (8 vaccine doses) of Spirolept® vaccine.

      The study will be conducted at the Occupational Health Centre of companies employing workers
      at risk of leptospirosis for their occupational activities. Study participants will be
      selected from the company Occupational Health Centre database where each employee is
      registered. All workers are regularly followed-up and their medical and vaccination history
      recorded. Subjects selection will occur according the number of booster doses received
      (having received at least the 2nd booster and no more than the 6th booster). After they have
      signed the informed consent form, subjects will be recruited into the study and if all
      inclusion and exclusion criteria are met they will be taken a blood sample.

      Anti-leptospira IgG antibody will be measured by a validated ELISA. Other assay may be
      performed to further characterize anti-leptospira antibodies. Data on subject demographics,
      relevant medical history, vaccination dates, and blood collection will be recorded in an
      appropriate Case Report Form.

      The study does not include any vaccination.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study will be conducted at the Occupational Health Centre of companies employing
        workers at risk of leptospirosis for their occupational activities. Study participants will
        be selected from the company Occupational Health Centre database where each employee is
        registered. All workers are regularly followed-up and their medical and vaccination history
        recorded. Subjects selection will occur according the number of booster doses received
        (having received at least the 2nd booster and no more than the 6th booster).
      
Biospecimen description: 
      IgG, GIT are studied on serum
    
Keywords: Leptospirosis
Study of SPM 962 in Patients With Restless Legs Syndrome (RLS)
Condition: Idiopathic Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the clinical efficacy and safety of SPM962 in
      patients with restless legs syndrome (RLS) with once-daily repeated doses of 4.5mg and 6.75mg
      during a 13-week dose-titration and maintenance period. This is a multi-center, randomized,
      placebo-controlled, double-blind, 3-armed parallel group comparison study.

      Efficacy will be determined by investigating the superiority of SPM962 to placebo in terms of
      the primary efficacy variable, change in International Restless Legs Syndrome Rating Scale
      (IRLS) total score from baseline to the end of the dose-maintenance period.
    


Intervention name(s): SPM 962; SPM 962; Placebo of SPM 962
Intervention type(s): Drug; Drug; Drug
Intervention description(s): once a daily transdermal administration started at 2.25 mg/day to 4.5 mg/day for 13 weeks; once a daily transdermal administration started at 2.25 mg/day to 6.75 mg/day for 13 weeks; once a daily transdermal administration for 13 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Heat Loss Prevention in Delivery Room Using a Polyethylene Cap
Condition: Hypothermia, Preterm Infants
MeSH terms: Premature Birth; Hypothermia
Study type: Interventional
Phase: Phase 3

Summary: 
      It is apparent that the head of a preterm infant should not be left uncovered, however it
      remains unclear whether covering the head of a preterm baby with plastic wrapping is
      effective in preventing heat loss.

      We conducted a prospective, randomised, controlled trial in very preterm infants to evaluate
      if a polyethylene cap prevents heat loss after delivery better than polyethylene occlusive
      wrapping and conventional drying. Furthermore, we assessed body temperature 1 hour after
      admission to Neonatal Intensive Care Unit (NICU) to evaluate whether the polyethylene cap
      prevents postnatal heat loss.
    

Detailed description: 
      The primary outcome measure was axillary temperature taken on admission to the NICU
      (immediately after cap and wrap removal) and again 1 hour later. Axillary temperature was
      measured using a digital thermometer (Terumo Digital Clinical Thermometer C202, Terumo
      Corporation, Tokio, Japan). The occurrence of hypothermia, defined as axillary temperature
      less then 36.4°C, on NICU admission was also evaluated.

      Secondary outcomes included mortality prior to hospital discharge, presence of major brain
      injury (sonographic evidence of intraventricular hemorrhage with ventricular dilatation,
      parenchymal hemorrhagic infarction, or periventricular leukomalacia), tracheal intubation at
      birth, Apgar scores, delivery to admission time, blood gas analysis and serum glucose
      concentration on NICU admission.
    

Intervention name(s): Polyethylene cap; Polyethylene wrap; conventional treatment
Intervention type(s): Device; Device; Other
Intervention description(s): In the cap group, the head of the infant was covered with a polyethylene cap immediately after birth; Infants in the wrap group were placed into the polyethylene bag, while still wet, up to their necks; only the head was dried.; Infants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: delivery room, polyethylene cap, preterm infant, temperature
Text Messaging-Based Smoking Cessation Program for Homeless Youth
Condition: Cigarette Smoking
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Unaccompanied homeless youth smoke at much higher rates than non-homeless adolescents and
      young adults. Many homeless youth smokers are motivated to quit; yet, strategies specifically
      developed for this vulnerable population are lacking. This study will develop and pilot test
      a text messaging intervention (also known as a TMI) to help homeless youth quit smoking. Text
      messaging can provide ongoing support for homeless youth during a quit attempt, which is
      important given that these youth tend to be highly mobile and lack regular access to health
      services. Participants in this study will be homeless youth who currently smoke and are
      motivated to quit smoking. All participants will receive a 30-minute group-based smoking
      cessation counseling session and a nicotine replacement product. Half of these smokers will
      also receive the TMI, for 6 weeks following the group counseling session, which will provide
      ongoing support for quitting. The main goal of this study is to investigate whether receiving
      the TMI results in greater reductions in cigarette smoking over a 3-month period compared to
      receiving the group counseling session alone.
    


Intervention name(s): Group counseling and nicotine replacement; Group counseling, nicotine replacement, and text messaging support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive a 30-minute group smoking cessation counseling session and a supply of nicotine replacement.; Participants will receive a 30-minute group smoking cessation counseling session, a supply of nicotine replacement, and the 6-week text messaging intervention to provide ongoing support for quitting
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Drug-drug-interaction Study to Assess the Effect of Darolutamide on the Pharmacokinetics of Probe Substrates of CYP3A4 and P-gp in Healthy Male Volunteers
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the effect of darolutamide on the pharmacokinetics of a probe CYP3A4 substrate and
      Pgp substrate
    


Intervention name(s): Dabigatran etexilate; Midazolam; BAY1841788 (darolutamide)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In Period 1, Day 1 a single dose of 75 mg will be administered after breakfast In Period 2, Day 3 a single dose of 75 mg will be administered prior to breakfast In Period 2, Day 9 a single dose of 75 mg will be administered after breakfast; In Period 1, Day 1 a single dose of 1 mg will be administered after breakfast In Period 2, Day 9 a single dose of 1 mg will be administered after breakfast; In Period 2, Days 1-11 600 mg twice a day (as 2 x 300 mg tablets) will be administered after breakfast
Intervention MeSH terms: Midazolam; Dabigatran
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug-drug interaction
A Study to Investigate the Effect of Food on the PK, PD of CKD-381 in Healthy Volunteers
Condition: GERD
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate the effect of food on the Pharmacokinetics and pharmacodynamics of
      CKD-381 in healthy volunteers
    

Detailed description: 
      A randomized, open-label, single-dose, crossover study to investigate the effect of food on
      the pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers
    

Intervention name(s): CKD-381
Intervention type(s): Drug
Intervention description(s): single-dose, oral administration of CKD-381 1 tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CKD-381
The Effects of mHealth Intervention on Health Empower of Overweight and Obese Women's Body Weight During Pregnancy
Condition: Overweight and Obese Pregnant Women
MeSH terms: Overweight; Body Weight
Study type: Interventional

Summary: 
      evaluate the health empowerment program with mHealth to promote physical activity for
      overweight and obese pregnant women.
    

Detailed description: 
      This two-phase study develops an mhealth application (app) based on social-cognitive theory
      (SCT) and evaluates its effectiveness for overweight and obese women, which can help to
      prevent excessive GWG by enhancing optimal weight and healthy behavior during pregnancy.
    

Intervention name(s): empowerment program with mHealth
Intervention type(s): Behavioral
Intervention description(s): empowerment program with mHealth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Preparing the Personal Physician for Practice (P4)
Condition: Healthy
Study type: Observational

Summary: 
      We would like to better understand how different educational strategies may influence the
      practice of family medicine. More specifically, we are interested in participant satisfaction
      with the educational program, participant retainment in this career, and to see if the
      curricular change better prepares participants for contemporary clinical practice.
    

Detailed description: 
      In 2004, the Future of Family Medicine report called for implementation of innovative
      strategies in residency education, allowing translational key insights from the national
      demonstration project toward new approaches to family medicine training. Taking full
      advantage of the P4 Project will require careful evaluation planning and implementation. A
      comprehensive evaluation plan for the P4 Project will be implemented by a core evaluation
      team that will interact with site-specific evaluators.

      The P4 evaluation program represents an observational case series assessment of selected
      residency programs. It is not an intervention trial; rather each residency program will
      systematically enroll cohorts of learners who will be exposed to curricular content and
      learning approaches that will likely be innovative and unique. In the absence of a rigorous
      study design, core data elements should be obtained from each program including: learner
      characteristics, program characteristics, and both nationally available data and targeted
      validated instruments that can link specific educational interventions to learners knowledge,
      attitudes and skills.
    

Intervention name(s): Evaluating Educational Models
Intervention type(s): Other
Intervention description(s): Evaluating various forms of educational models for physicians.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All Family medicine residents who accept employment as a resident in the Dept of Family
        Medicine will be part of the study population. These residents are interviewed prior to
        acceptance. Acceptance can occur via the NRMP or osteopathic match process or outside of
        the match
      
Keywords: Outpatient continuity training; Relevant, Patient-centered curriculum; Evaluation; New graduation requirements
Effect of Autologous Fat Grafting on Acute Burn Wound Healing
Condition: Burns
MeSH terms: Burns
Study type: Interventional
Phase: Phase 3

Summary: 
      the study evaluates the role of autologous fat grafting and the usage of nanofat in the
      treatment of the acute burn injuries in different genders and its influences on the healing
      time and hospital stay, pain control, the need and take of a split thickness skin graft and
      its size, and the end resulting early scarring, in comparison with control group that were
      treated with traditional methods, so as to find out new method of treating burn injuries and
      decreasing its morbidity.
    

Detailed description: 
      as the patient is admitted, full evaluation locally ( as regard the wound itself and the
      areas of fat harvesting) and generally (assessment of the general condition) is done, fluid
      resuscitation is started as the unit protocol hand in hand with the analgesia and other
      medications prescribed according to the unit protocol.

      the patient's general condition is optimized for surgery of the fat extraction and grafting
      which typically should be within the first 6 days of admission.

      then under anesthesia (any possible type from local and regional up to general anesthesia)
      liposuction procedure is performed, then fat is processed then grafted at the wound site with
      other portion prepared as nanofat for topical use and wound coverage, then sterile dressing
      is applied.

      typically follow up is held daily with the dressing change day after another with the use of
      the nanofat only and sterile dressing
    

Intervention name(s): autologous fat grafting; Topical Cream; split thickness skin grafting
Intervention type(s): Procedure; Drug; Procedure
Intervention description(s): regular liposuction procedure at which sufficient amount of fat is extracted from the patient and then the fat is processed then grafted underneath the burn wound; serial dressing with topical agents e.g Silver Sulphadiazine; depridment and split thickness skin grafting
Other intervention name(s): liposuction and lipofilling; dressing; skin grafting
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups one will have the fat grafting and the other will be the control group treated with the conventional methods
Masking: None (Open Label)
Primary purpose: Treatment
Analysis of Neurocognitive Elements of Attention After Chemotherapy
Condition: Cancer Nos
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      Data for this study will be obtained from the University of Texas Southwestern Medical Center
      Simmons Comprehensive Cancer Center. Participants will be recruited through Simmons Cancer
      Center. One hundred female breast cancer patients who have completed adjuvant chemotherapy
      will be enrolled. In order to reach this number, it is estimated that up to 125 eligible
      participants will need to be recruited. The study will last approximately two years.
      Participants will undergo one cognitive testing session, and each subject's total
      participation time will last no more than two hours.
    

Detailed description: 
      The study visit will be scheduled for three to six months after completing adjuvant
      chemotherapy treatment. At the study visit, informed consent will be obtained and
      neurocognitive attention testing will be performed. The assessments chosen were carefully
      selected based on breadth, psychometric properties, standardized broad clinical use, good
      external validity and time efficiency. The testing time for the battery of neuropsychological
      tests is approximately 45-60 minutes. Participants will also be asked to complete a packet of
      several questionnaires including several self-rated measures of mood and quality of life, in
      addition to a brief questionnaire to obtain information about exercise, sleep, and education
      and employment backgrounds. It is estimated that questionnaire completion will require no
      more than 30 minutes. Participants will be seen on only one occasion, and may receive, upon
      request, written feedback about the results of the evaluation.
    

Intervention name(s): Cognitive Assessment
Intervention type(s): Other
Intervention description(s): Cognitive testing session
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Chronobiology and Childhood Obesity in a Mediterranean Spanish Population
Condition: Obesity; Chronobiology Disorders
MeSH terms: Chronobiology Disorders; Obesity; Pediatric Obesity
Study type: Observational

Summary: 
      The main objective is to investigate chronobiological aspects of childhood obesity studying
      the potential relationship between meal patterns and circadian rhythmicity in a
      cross-sectional sample of obese, overweight and normal weight children/adolescent.
    

Detailed description: 
      Childhood obesity has more than doubled in children and tripled in adolescents in the past 30
      y. As consequence, increasingly children and adolescents suffer from elevated blood pressure,
      impaired glucose tolerance, hyperinsulinemia, dyslipidemia. Obesity has a multifactorial
      etiology since there are potentially numerous contributors to its development and
      progression. Chronobiology, the science that studies periodic (cyclic) changes in living
      organisms, has been recently proposed as a new and promising topic to investigate.
      Alterations of circadian (24 h oscillations) system may contribute to obesity and its
      complications development such as high blood pressure, insulin resistance, altered fasting
      lipid profile. Conversely, in a vicious manner, obesity has been regarded as a fault in the
      circadian system explainable by the association with imbalances and fluctuations of
      hormones/genes expressions rhythms under the influence of body weight changes.

      Thus, the study will examine changes in circadian rhythmicity over a week period. The primary
      end point will be to evaluate differences between obese/overweight and non-obese children in
      chronotypes and the responses of these parameters to meal patterns. In particular,
      non-invasive measures that are well-established determinants of chronotypes will form the
      core endpoints for the study. Well designed and age-appropriate questionnaires will provide
      further information in order to study correlations with eating, sleeping and sedentary/active
      behaviors.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children from schools who enter voluntarily in Spanish city of Murcia, located on the
        Southeast coast of the Mediterranean Sea.
      
Biospecimen description: 
      saliva
    
Keywords: Obesity; Chronobiology; Circadian
Electroacupuncture as a Complement to Usual Care for Patients With Non-acute Pain After Back Surgery
Condition: Low Back Pain; Pain, Postoperative; Failed Back Surgery Syndrome
MeSH terms: Low Back Pain; Pain, Postoperative; Failed Back Surgery Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to find out the effectiveness of integrative medicine model for
      pain relief and improvement of function and quality of life on the patients with pain after
      back surgery.
    


Intervention name(s): electroacupuncture and usual care; Usual care
Intervention type(s): Device; Device
Intervention description(s): Electroacupuncture: Using 0.25 mm (diameter) X 0.40 mm (length) sized disposable stainless steel needles, electric stimulation will be applied with an electronic stimulator (ES-160, ITO co. LTD, Japan) 2 times/week × 4 weeks. Stimulation will be applied with the current in biphasic wave form. Acupuncture points are Jia-ji (Ex-B2, L3-L5; bilateral) as necessary points and reasonable points (according to decision of practitioner) as accessory points. Each session lasts 15 minutes.
Usual care: Physical therapy and patient education will be performed 2 times per week for 4 weeks. ICT lasts 15 minutes and Hot or Ice pack lasts 10minutes. Doctors will educate patient physiology, pathology, and epidemiology of low back pain. And also suitable postures and exercises for low back pain will be educated.; Usual care: Physical therapy and patient education will be performed 2 times per week for 4 weeks. ICT lasts 15 minutes and Hot or Ice pack lasts 10minutes. Doctors will educate patient physiology, pathology, and epidemiology of low back pain. And also suitable postures and exercises for low back pain will be educated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
ALACOVID Study for Vaccinated Subjects
Condition: COVID-19 Respiratory Infection
MeSH terms: Infections; Respiratory Tract Infections
Study type: Interventional

Summary: 
      In this study, it is hypothesized that administration of 5-ALA-Phosphate + SFC in subjects
      vaccinated against Covid-19 could contribute in enhancing the targeted function of the immune
      system, which might lead to re-activation and/or increase of the vaccination response. Thus,
      in the present study, we will be evaluating the safety and efficacy of 5-ALA-Phosphate + SFC
      in subjects receiving the Covid-19 vaccine.
    


Intervention name(s): 150 mg 5-ALAPhosphate + SFC; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 2 capsules in the morning after breakfast (before 11 AM) and 1 capsule in the evening after a snack or after dinner (before 8 PM) orally with water for 21 days.; No Description for the intervention
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: An Open-Label, Pilot Study
Masking: None (Open Label)
Primary purpose: Supportive Care