bioihbjkbjnl/mcl2 huggingface dataset:
Physical Activity and Physical Fitness Parameters in COVID-19 Lockdown
Condition: Assessment, Self
Study type: Observational [Patient Registry]

Summary: 
      In this study; it was aimed to compare the physical activity levels of students who continued
      their university education face-to-face before the COVID-19 lockdown, and the values of
      physical activity levels related to health, physical activity levels and health-related
      physical fitness parameters in the post-lockdown period.
    

Detailed description: 
      Within the scope of the course, the demographic information of the students will be recorded
      and physical activity status, physical fitness parameters, muscle endurance, cardiovascular
      endurance, flexibility and body composition will be evaluated.
    

Intervention name(s): Evaluation
Intervention type(s): Behavioral
Intervention description(s): Within the scope of the course, the demographic information of the students (such as height, weight, body mass index) is recorded and the physical activity status is recorded with "International Physical Activity Questionnaire Short Form (UFAA)". Cardiovascular endurance with "6-Minute Walking Test", flexibility and circumference of waist, hip and neck with the "Sit and Lie Test" and body composition and "Body Fat Ratio "will be evaluated. After a full year of quarantine, the same students who were previously evaluated and accepted to participate in the current study will be evaluated with online remote video viewing methods (Teams, Zoom, etc.) and, with the same tests and measurements under supervision by the researchers.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Students of university
The Therapeutic Effect of Different Doses of Capecitabine
Condition: Capecitabine
Study type: Interventional

Summary: 
      To observe the clinical efficacy and adverse reactions of capecitabine in the treatment of
      advanced colon cancer. A total of 150 patients with advanced colon cancer were selected by
      convenience sampling and then were divided into the control group (n = 50), the medium-dose
      group (n = 50), and the low-dose group (n = 50) using a random number table.Different
      administration regimens of capecitabine were given, and the treatment course was
      appropriately extended. The therapeutic effect and incidence of adverse reactions were
      observed.
    

Detailed description: 
      To observe the clinical efficacy and adverse reactions of capecitabine in the treatment of
      advanced colon cancer. A total of 150 patients with advanced colon cancer were selected by
      convenience sampling and then were divided into the control group (n = 50), the medium-dose
      group (n = 50), and the low-dose group (n = 50) using a random number table.The control group
      was treated with 2,500 mg/m2 capecitabine, with 2,000 mg/m2 capecitabine for the medium-dose
      group and 1,500 mg/m2 capecitabine for the low-dose group. Afterward, the response rate,
      quality of life, and adverse reactions of the three groups were collected for comparison.
    

Intervention name(s): capecitabine
Intervention type(s): Drug
Intervention description(s): The control group was treated with 2,500 mg/m2 capecitabine, with 2,000 mg/m2 capecitabine for the medium-dose group and 1,500 mg/m2 capecitabine for the low-dose group.
Intervention MeSH terms: Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Capecitabine; Advanced colon cancer; Clinical efficacy; Adverse reactions
Multiple Ascending Doses (MAD) of Anti-A Disintegrin and Metalloproteinase With Thrombospondin Motifs-5 (Anti-ADAMTS-5) Nanobody in Participants With Knee Osteoarthritis (OA)
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be conducted in participants with symptomatic knee OA to explore the safety,
      tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of MAD of
      M6495.
    


Intervention name(s): M6495; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive escalated dose of M6495 bi-weekly on Day 1, 15 and 29 in cohort 1 to 3 and weekly on Day 1, 8, 15, 22, 29 and 36 in cohort 4.; Participants will receive placebo matched to M6495 bi-weekly on Day 1, 15 and 29 in cohort 1 to 3 and weekly on Day 1, 8, 15, 22, 29 and 36 in cohort 4.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: M6495; Anti-ADAMTS-5 Nanobody; Osteoarthritis
Feeding Readiness and Oral Feeding Success in Preterm Infants
Condition: Preterm; Feeding Behavior; Enteral Feeding Intolerance
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      To examine the effects of sensorimotor interventions applied to in preterm infants on
      readiness for feeding and oral feeding success.
    

Detailed description: 
      The preterm neonate population cannot potentially be fed orally for a long time in the
      postnatal period. However, the inability of preterm infants to be fed orally as soon as they
      are born is not a disease, their adaptation to the external environment of the uterus is more
      complicated because their physiological functions are not yet mature. This also means long
      hospital stays for premature babies. Therefore, the American Academy of Pediatrics (AAP) has
      determined that oral feeding is one of the main criteria for the discharge of the preterm
      infant from the hospital.

      Many studies have been conducted on preterm infants on optimizing oral feeding performance.
      Studies improve oral feeding skills of preterm infants by applying various sensorimotor
      interventions and cue-based feeding protocols to improve oral feeding performance. These
      sensorimotor interventions; non-nutritive sucking (pacifier), sucking-swallowing exercises,
      oral support, oral stimulation, tactile stimulation, kinesthetic stimulation, sound, smell,
      audio-visual stimulations, etc. methods were used alone or in combination with these methods.

      It has been shown in studies that sensorimotor interventions increase the success of oral
      feeding in preterms, increase the daily feeding volume, increase weight gain, reduce the cost
      by shortening the hospital stay, shorten the transition time from gastric feeding to
      oral/breastfeeding and help mother-infant bonding.

      This thesis study was conducted using evidence-based interventions that can facilitate the
      development of oral feeding skills in preterm infants, the feeding problems they encounter,
      and their transition from gastric feeding to oral feeding.
    

Intervention name(s): Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)
Intervention type(s): Other
Intervention description(s): Sensorimotor interventions were applied to in preterm infants between 30-33 weeks of age for 10 days. After that, preterms were included in the "Six-phase feeding progression protocol".
Other intervention name(s): Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This research is a randomized controlled study with a control group design with pre-test and post-test measurements from experimental research designs.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Preterm; Feeding Readiness; Oral feeding; sensorimotor intervention; neonatal nursing
Observational Study to Assess Protection to Mumps in Children Received One-dose Mumps-containing Vaccine
Condition: Parotid Gland Infection; Fever
MeSH terms: Mumps
Study type: Observational

Summary: 
      This study was aimed to conduct a 3-year perspective study to observe the immunological
      effect of one-dose mumps-containing vaccine, monitor the incidence of mumps in vaccinated
      population aged 3-7 years，and provide basis for adjusting MMR immunization strategy in
      Jiangsu province, China.
    

Detailed description: 
      in 3-7 years old children with high risk of mumps, epidemiological investigation of the serum
      IgG antibody level were conducted, and then a prospective observational cohort was
      established in the population with a history of mumps vaccination, and the incidence of mumps
      in each antibody level group will be observed, the relationship between different antibody
      levels and the incidence after mumps vaccinated were analyzed, to explore attenuation of
      mumps IgG antibody levels in the body,S79 vaccine strain against F genotype mumps' antigenic
      cross-reactivity and the protective effect of antibodies.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        children aged 3-7 years who received as least one dose mumps-containing vaccine
      
Biospecimen description: 
      blood samples
    
Keywords: mumps; immunity; cohort study; children; vaccine
Safety and Efficacy Study of DAV132 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether DAV132 is safe and effective for capturing
      fecal residues of moxifloxacin in healthy volunteers.
    

Detailed description: 
      The proposed study, DAV132-CL-1002, is to evaluate performances of DAV132 in healthy
      volunteers:

        -  To capture residual concentration of antibiotics in colon without interfering with their
           systemic pharmacokinetics parameters.

        -  To explore the influence of DAV132 to prevent the modification of gut flora due to
           antibiotic.

      In addition, the security and acceptability of DAV132 used during 7 days will be evaluated.

      The proposed study is prospective, randomized, controlled, four parallel groups, repeated
      doses, open-label study blinded to analytical and microbiological evaluations.
    

Intervention name(s): DAV132; Moxifloxacin; Negative Control
Intervention type(s): Device; Drug; Other
Intervention description(s): DAV132 is associated to moxifloxacin or it is evaluated alone; Moxifloxacin is used alone or associated to DAV132; Moxifloxacin is used alone
Other intervention name(s): Avelox
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
HDAC Activity in Peripheral Skeletal Muscle in COPD
Condition: COPD
Study type: Observational

Summary: 
      We wish to study the effect of Chronic Obstructive Pulmonary Disease on the activity of the
      nuclear transcription pathway in peripheral skeletal muscle to determine whether altered
      activity of this pathway may be responsible for the muscle dysfunction observed in these
      patients.
    

Detailed description: 
      Peripheral muscle dysfunction is well recognised in COPD. We wish to study patients who we
      have found to have weak quadriceps muscles and study the molecular mechanisms underlying this
      problem. Patients will be well characterised with regard to their physiologic parameters and
      quadriceps muscle biopsies will be taken. These biopsy samples will be analysed with respect
      to NFkappaB activity and HDAC activity by nuclear extraction and for muscle inflammatory
      cytokines. We know that in the lung tissue of COPD patients there is evidence of a reduction
      in HDAC activity which might be responsible for the higher levels of pronflammatory cytokines
      in the lung. We will also study a healthy control group and a small selection of patients who
      are in respiratory failure due to idiopathic scoliosis in the same way.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        COPD patients and healthy age-and sex-matched controls
      
Biospecimen description: 
      Plasma and serum samples, quadriceps muscle specimens
Urinary Retention Following taTME VS laTME Total Mesorectal Excision for Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms; Urinary Retention
Study type: Interventional

Summary: 
      A comprehensive study with prospectively collected data. These patients were assigned to
      either the taTME group or the laTME group according to the surgery procedure received
    

Detailed description: 
      Transanal total mesorectal excision has emerged as a potential solution to certain
      limitations associated with laparoscopic total mesorectal excision in rectal cancer patients.
      Differences in surgical approaches have raised questions regarding their impact on the risk
      of postoperative urinary retention, with limited data available from large scale study.
    

Intervention name(s): transanal total mesorectal excision; Laparoscopic Total Mesorectal Excision
Intervention type(s): Procedure; Procedure
Intervention description(s): a transanal bottom-up approach was employed for the TME procedure; Laparoscopic Total Mesorectal Excision
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: urinary retention
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)
Condition: Pemphigus Vulgaris (PV)
MeSH terms: Pemphigus
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to assess the efficacy and safety of CellCept (1 g or 1.5 g orally
      twice daily for 52 weeks) in patients with pemphigus vulgaris receiving prednisone or other
      corticosteroids. During the study, patients had their corticosteroid dose gradually reduced
      if they responded to treatment. The anticipated time on study treatment was 12 months, and
      the target sample size was <100 individuals.
    


Intervention name(s): Mycophenolate Mofetil 2 g/Day; Mycophenolate Mofetil (MMF) 3 g/Day; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks; Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks; Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Steps Toward Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population
Condition: Physical Inactivity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This feasibility study specifically addresses the issue of adapting US dietary guidelines
      physical activity recommendations to the population of the Lower Mississippi Delta. The
      hypothesis is that including a pedometer as a self-monitoring tool as part of adapted
      physical activity guidelines will result in greater immediate increases in physical activity
      (as monitored by an accelerometer) than an education program alone.
    

Detailed description: 
      The purpose of this study was to determine if a short-term pedometer-based intervention
      results in immediate increases in time spent in moderate-to-vigorous physical activity (MVPA)
      compared to a minimal educational intervention.A sample of 43 overweight adults 35 to 64
      years of age participated in a one week pedometer-based feasibility trial monitored by
      accelerometry. Participants were randomized into a one-week education-only group or a group
      that also wore a pedometer. Accelerometer-measured MVPA was measured over 7 days at baseline
      and post-intervention.
    

Intervention name(s): Physical Activity Educational Materials; Pedometer
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A brochure was provided to participants about the health benefits of physical activity and physical activity recommendations; A pedometer was provided to participants in addition to educational materials about the health benefits of physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pedometer; accelerometer; moderate-to-vigorous physical activity; adult; randomized trial
An Information-Motivation-Behavioral Skills (IMB) Intervention to Promote Human Papillomavirus Vaccination Among Women
Condition: Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections
Study type: Interventional

Summary: 
      HPV infections are prominent among college-aged women. Although HPV vaccines decrease women's
      risk for cervical cancer, vaccination rates remain inadequate. This study explored the
      utility of an Information-Motivation-Behavioral Skills intervention in promoting HPV
      vaccination knowledge, motivation, and behavioral skills among college aged women.
    

Detailed description: 
      HPV infections are prominent among college-aged women. Although HPV vaccines decrease women's
      risk for cervical cancer, vaccination rates remain inadequate. This study explored the
      utility of an Information-Motivation-Behavioral Skills intervention in promoting HPV
      vaccination knowledge, motivation, and behavioral skills among college aged women.

      Methods: Participants were randomly assigned to a single-session intervention or
      attention-control arm and were assessed at pre-intervention, post-intervention, and at
      1-month follow-up.
    

Intervention name(s): IMB Intervention Group; Attention Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the IMB group received information specific to HPV, cervical cancer, and the HPV vaccine. This information was delivered in a group setting, and it was delivered via a PowerPoint presentation that included short video clips.; Participants in the attention control arm watched a PowerPoint that contained a series of short video clips encompassing aspects of women's general and sexual health. This was also conducted in a group setting.
Other intervention name(s): IMB Based Educational Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: HPV
Use of Surgify Safety Burr in Hard Tissue Cutting, Head and Spine Area
Condition: Spine Surgery; Surgery
Study type: Observational

Summary: 
      Purpose of the study: To evaluate whether the SSB is safe, useful, beneficial and effective
      in drilling, cutting and removal of bone tissue in neurosurgical and spine procedures.
    

Detailed description: 
      Sponsored observational clinical pilot study with no control group. Aim is to get a maximum
      of 20 study subjects, who have disease of the spine or head requiring surgery with bone
      removal and who are willing to participate into this study.
    

Intervention name(s): Surgify Safety Burr
Intervention type(s): Device
Intervention description(s): Use of Surgify Safety Burr in hard tissue cutting, head and spine area
Observational model: Case-Only
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Any 18 to 70 -year old patient scheduled to back/head operation can be recruited according
        to other inclusion and exclusion criteria.
MK-8189 Safety and Tolerability in Participants With Alzheimer's Disease With or Without Symptoms of Agitation-Aggression and/or Psychosis (MK-8189-017)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Aggression
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of multiple ascending
      doses of MK-8189 in participants with Alzheimer's Disease (AD) with or without symptoms of
      agitation-aggression and/or psychosis.
    


Intervention name(s): MK-8189; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MK-8189 administered orally once a day (QD) at a titration via tablet in 4 mg and 12 mg dose strengths; MK-8189 matching placebo administered orally QD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study to Investigate the Effect of Superba Boost on the Skin.
Condition: Physiology, Skin
Study type: Interventional

Summary: 
      Study to determine the effect of 12 weeks daily consumption of Superba Boost as compared to
      placebo on changes in Trans-Epidermal Water-Loss (TEWL).
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled, parallel group trial in 70
      healthy adult male and female subjects between 20 and 50 years. The primary objective is to
      assess whether Superba Boost krill oil administered at a dose of 1 g per day for 12 weeks (84
      days) has a positive effect on the TEWL, skin hydration and elasticity. At screening, the
      subjects must have TEWL values of >10 g/m2/h and <24.9 g/m2/h when measured by a TEWAmeter,
      i.e. within the range defined as normal and healthy skin. The change in omega-3 index,
      defined as EPA and DHA as percentage of total fatty acids in red blood cells, will be
      measured and correlated to the changes in the skin parameters.

      The study consists of 4 visits: the screening visit (V1), baseline visit / week 0 / Start of
      treatment (V2), Interim / Week 6 (V3) and week 12 / end of treatment (V4) . In this study,
      subjects must have a low habitual consumption of fatty fish and seafood, defined as a
      frequency of twice per month or less will be recruited. Each subject must fulfill all
      inclusion criteria and will not be allowed to meet any of the exclusion criteria.
    

Intervention name(s): Superba Boost (Active); Vegetable oil (Placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): To assess changes in Trans-epidermal water loss (TEWL), measured at baseline and after 12 weeks of daily consumption with Superba Boost.; To assess changes in Trans-epidermal water loss (TEWL), measured at baseline and after 12 weeks of daily consumption with Placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects who successfully meet the eligibility criteria will be randomized on a 1:1 basis, to receive Superba Boost or Placebo.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science