bioihbjkbjnl/mcl2 huggingface dataset:
Dress for Success: Can Just Dressing for the Gym Help Going to the Gym?
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the investigators ask the question: can incentivizing smaller, less costly
      behaviors-like just getting yourself dressed to go to the gym-be more effective (and
      palatable) than incentivizing the larger goal directly?
    

Detailed description: 
      To test this hypothesis, the investigators will randomly assign participants to one of three
      experimental conditions: (1) control, (2) dress for success (low effort), and (2) exercise
      for success (high effort). The investigators' hypothesis is that incentivizing a low effort,
      indirect/workout-related behavior (i.e., "dressing for success") will be more effective in
      motivating workouts than the control, despite a lack of economic incentive for the workout
      itself. Additionally, the investigators will compare workout levels for groups 2 and 3; if
      there is no difference between the two groups (or if 2 has higher exercise rates than 3),
      this would suggest that indirect incentives may be as effective as direct ones.
    

Intervention name(s): Take and send a selfie; Workout gears; Exercise
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Direction to take and send a selfie.; Direction to wear workout gears.; Direction to complete a 30 minute workout.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Indirect incentives; Exercise more
Effect of Preoperative Abdominal Exercises and Russian Current on Muscle Strength Post Ventral Hernioplasty
Condition: Muscle Strength
Study type: Interventional

Summary: 
      The study was conducted to investigate the effect of preoperative graduated abdominal
      strengthening exercises and Russian stimulation on the abdominal muscles strength after
      ventral hernioplasty by using isokinetic dynamometer and Ultrasonography as methods of
      measurement.
    

Detailed description: 
      The study was conducted to investigate the effect of preoperative graduated abdominal
      strengthening exercises and Russian stimulation on the abdominal muscles strength after
      ventral hernioplasty by using isokinetic dynamometer and Ultrasonography as methods of
      measurement.
    

Intervention name(s): Graduated abdominal strengthening exercises; The Russian current stimulation; Graduated abdominal strengthening exercises and the Russian current stimulation
Intervention type(s): Other; Device; Combination Product
Intervention description(s): Exercise mat and inflatable Swiss ball
Wall bar, wedges, elastic tubing; The Russian current is used for enhancing muscle; the muscular fiber by the electric stimulation.; Combination between The Russian current and abdominal exercises
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Sixty patients with ventral hernia, preoperatively, were randomly distributed into four equal groups: groups (A) & (B) & (C) ( three study groups ) and group (D) ( control group ).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ventral hernia; graduated abdominal exercises; isokinetic dynamometer.
Power of Peanuts School Feeding
Condition: School Feeding Programs; Nutrition Supplements
Study type: Interventional

Summary: 
      This will be a two-phase protocol. Phase 1 will include the development of the peanut-based
      school food, and a small formative research study on the acceptability and consumption of the
      school food study intervention. This will occur among children 5-12 yr in the Mion district,
      60 school aged children between 6-12 years old will be recruited to participate in a 3 week
      consumption and acceptability study. An integral part of the food development process is
      acceptability testing. A child must like and want to eat a new food if it is to be consumed
      as prescribed and effective in potential improving linear growth and cognitive performance.
      This study will confirm that food developed for the school feeding clinical trial will be
      consumed as dosed and what additional snack food offerings may be useful in encouraging
      consumption.

      Phase 2 will be a individually randomized, investigator blinded, controlled clinical
      effectiveness trial of a peanut-based school meal with and without milk powder compared to a
      control meal for linear growth and cognitive performance. 880 children 5 to 12 years old,
      healthy, enrolled in primary school, including kindergarten at 6 selected schools in the Mion
      district will be randomized to receive one of three school foods, a peanut-based food with
      milk, a peanut-based food without milk and a control group composed of commonly available
      tuber/cereal. The sample size accounts for up to 15% attrition for a final sample size of 750
      with a total 250 eligible children enrolled in each group. Enrolled children will receive the
      meal daily during the school lunch period for an entire school year. At enrollment and upon
      completion, anthropometric measurements and body composition data will be collected and a
      tablet- based, language independent cognitive test battery will be administered. Basic
      demographic information and school attendance information will be collected as well.
    


Intervention name(s): Standard meal; School food ready-to-use; School food ready-to-use plus Milk
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): local porridge with a vitamin and mineral sprinkle powder that will be mixed in after cooking; 80 gram per day sachet containing peanut paste with oil, sugar, cowpea, maize, and vitamin and minerals; 80 gram per day sachet containing peanut paste with oil, sugar, cowpea, non-fat dried milk and vitamin and minerals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to determine the effectiveness of treatment with raloxifene, an
      estrogen-like medication approved by the Food and Drug Administration for the treatment of
      osteoporosis, in improving memory and the ability to live independently in postmenopausal
      women with Alzheimer's disease.
    

Detailed description: 
      The aim of this study is to determine the effectiveness of treatment with raloxifene, an
      estrogen-like medication (classified as Selective Estrogen Receptor Modulators (SER's))
      approved by the Food and Drug Administration for the treatment of osteoporosis, in improving
      memory and the ability to live independently in postmenopausal women with Alzheimer's
      disease. Patients who volunteer for this study will need to visit the clinic 7 times
      (participate) over a period of five months and will receive either raloxifene or a harmless,
      inactive pill called a placebo. Neither the volunteers nor the study staff will know which
      type of pill a patient receives. Patients must be generally healthy and have mild-to-moderate
      dementia. There must be a patient caregiver who can watch for side effects and ensure that
      the patient takes the study pills on schedule over a period of three months.

      Patients will undergo neuropsychological tests and an evaluation of the ability to live
      independently at each visit as well as laboratory evaluations, such as the taking of blood.
      Each visit will last approximately 3 hours. A total of 20 patients is being recruited to
      participate in this study at the University of Wisconsin.
    

Intervention name(s): Raloxifene
Intervention type(s): Drug
Intervention MeSH terms: Raloxifene Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Alzheimer disease; Postmenopausal women; Hormone therapy
BIOEQUIVALENCE STUDY IN HEALTHY PARTICIPANTS COMPARING 4 MG AND 8 MG FESOTERODINE EXTENDED-RELEASE TABLETS (TOVIAZ™), MANUFACTURED AT ZWICKAU VERSUS FREIBURG
Condition: Neurogenic Detrusor Overactivity
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      Fesoterodine (Toviaz™) extended-release (ER) tablets are currently manufactured by Aesica
      Pharmaceuticals, Zwickau, Germany (Zwickau). An additional manufacturing location at Pfizer
      Freiburg, Germany (Freiburg) has been identified. This pivotal bioequivalence (BE) study is
      being conducted to satisfy the United States (US) Food and Drug Administration (FDA)
      regulatory requirements for the qualification of the Freiburg manufacturing site.

      Overall Study Design This is an open-label, randomized, single-dose, 4-period, 4-treatment,
      2-sequence, two 2-way crossover study in healthy participants. This study will assess the BE
      of Fesoterodine (Toviaz™) 4 mg and 8 mg ER tablets manufactured at Zwickau (Reference) versus
      Freiburg (Test). Study participants will include healthy male and/or female individuals
      between the ages of 18 and 55 years, inclusive. Approximately 18 participants who fulfill
      entry criteria will be randomized to 1 of the 2 treatment sequences as shown in the table
      below.
    


Intervention name(s): 4 mg Fesoterodine ER tablet from Zwickau; 4 mg fesoterodine ER tablet from Freiburg; 8 mg fesoterodine ER tablet from Zwickau; 8 mg fesoterodine ER tablet from Freiburg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Manufactured at Zwickau; Manufactured at Freiburg; Manufactured at Zwickau; Manufactured at Freiburg
Intervention MeSH terms: Fesoterodine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is an open-label, randomized, single-dose, 4-period, 4-treatment, 2-sequence, two 2-way crossover study in healthy participants. This study will assess the BE of Fesoterodine (Toviaz™) 4 mg and 8 mg ER tablets manufactured at Zwickau (Reference) versus Freiburg (Test). Study participants will include healthy male and/or female individuals between the ages of 18 and 55 years, inclusive. Approximately 18 participants who fulfill entry criteria will be randomized to 1 of the 2 treatment sequences as shown in the table below.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Phase I; Fesoterodine beads- in-capsule; bioequivalence; Pharmacokinetics; Toviaz
Assessing the Disintegration, Safety, and Acceptability of Placebo Vaginal Inserts for the Delivery of Vaginal Products
Condition: Vaginal Diseases
MeSH terms: Vaginal Diseases
Study type: Interventional

Summary: 
      This open-label study will examine the disintegration/disappearance time, safety, and
      acceptability of placebo vaginal inserts. Participants will use a placebo vaginal insert
      twice: first for an in-clinic disintegration/safety assessment, and a second time for an
      at-home acceptability assessment, with safety assessed at the following clinic visit.
    

Detailed description: 
      This open-label study will examine the disintegration/disappearance time, safety, and
      acceptability of placebo vaginal inserts. Participants will use a placebo vaginal insert
      twice: first for an in-clinic disintegration/safety assessment, and a second time for an
      at-home acceptability assessment, with safety assessed at the following clinic visit.

      Participants will be assigned to test their insert during either the follicular or luteal
      phase of their menstrual cycle, such that the number of women who test it in the follicular
      phase is approximately equal to the number who test it in the luteal phase.

      Once eligibility has been confirmed, the participant will complete an in-clinic
      disintegration test to estimate the amount of time required for disintegration and complete
      disappearance of the vaginal insert. Prior to and following the disintegration test, the
      participant will have a pelvic exam and vaginal swab(s) will be collected for development of
      adherence measures. Safety will be assessed by naked eye exam and report of adverse events
      (AEs).

      24 to 72 hours following the in-clinic disintegration test, the participant will use the
      vaginal insert at home and complete a standardized acceptability questionnaire 4 hours and 24
      hours after placement. The acceptability questionnaire will be returned to the clinic at the
      participant's next visit. The final clinic visit will be scheduled 24-72 hours after
      placement of the vaginal insert used at home.

      The final study visit will include a pelvic exam to assess safety and vaginal swab(s) will be
      collected for development of adherence measures. The participant will exit the study
      following the final study visit.

      This study is designed to test a single placebo vaginal insert, but it is possible additional
      inserts may become available for testing. Participants may re-enroll in the study for the
      testing of additional vaginal inserts as they become available.
    

Intervention name(s): Placebo Vaginal Insert
Intervention type(s): Other
Intervention description(s): Placebo insert
Intervention model: Single Group Assignment
Masking: None (Open Label)
To Evaluate Safety, Tolerability, Pharmacokinetics, And Food Effect Of Single Doses Of GSK945237 In Healthy Subjects
Condition: Healthy Subjects; Infections, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK945237 is the first molecule of a new chemical class that is being developed for treatment
      of respiratory tract and other infections such as skin and soft tissue. This study drug has
      been tested in animals but has never been given to humans. This is a two part study. The
      purpose of the first part is to study the side effects of this drug in humans, and to study
      how much of the drug gets absorbed in the blood stream The second part of this study will
      compare absorption of the study drug in the blood stream when given with food and when given
      under fasting conditions
    


Intervention name(s): GSK945237; Sugar Pill
Intervention type(s): Drug; Drug
Intervention description(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Healthy Volunteer
Balloon Catheters in Cases of Abnormal Placentation
Condition: Post Partum Bleeding
MeSH terms: Placenta Accreta; Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Placenta accreta is a relatively rare event, in which the placenta is abnormally implanted
      into the uterine myometrium. The most significant complication is intense bleeding, mainly
      during labor. The most important risk factors are previous cesarean delivery, placenta
      previa, and advanced maternal age. Cesarean hysterectomy is the recommended management.
      During the recent years, inserting intravascular balloon catheter for occlusion and/or
      arterial embolization, was introduced as an adjuvant therapy in order to minimize blood loss
      during cesarean hysterectomy or in conduct with conservative management with the intent of
      avoiding hysterectomy in selective cases. Contradicting reports exist regarding the
      effectiveness and safety of the catheters in cases of placenta accreta. The objective of this
      study is to estimate the efficacy of the balloon catheters among women diagnosed with a
      placenta accreta.
    


Intervention name(s): internal iliac catheterization
Intervention type(s): Procedure
Intervention description(s): Women in this arm will undergo internal iliac artery catheterization prior to the cesarean delivery
Other intervention name(s): internal iliac artery catheterization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Placenta accreta; Internal iliac artery catheterization; Post partum bleeding
Microbiome Influence on Seminal Quality
Condition: Infertility, Male
MeSH terms: Infertility; Infertility, Male
Study type: Observational

Summary: 
      The microbiome plays an important role in health and in some unknown etiologies. Some
      previous studies have identified bacteria in semen as a potential factor in male infertility.
      More studies are needed to discover associations between microbiomes and semen quality. In
      this study, forty semen samples from donors candidates will be collected where clinical
      criteria for seminal quality (volume, concentration, motility and morphology) will be
      measured and bacterial communities examined. With the next-generation sequencing of gene
      technology and bioinformatic analysis, we can investigate the associations between bacterial
      communities and seminal quality. It would be interesting to know if the proportion of certain
      bacteria is significantly higher in samples of normal seminal quality or significantly higher
      in samples of low seminal quality. This study could contribute to the current understanding
      of certain etiologies of male fertility.
    

Detailed description: 
      Surplus semen samples will be collected from donor candidates who come to the IVI Alicante
      clinic with ages between 18 and 35 years old and who intend to participate in the donation
      program for the semen bank, and come to evaluate their quality. Informed consent for this
      study will be given to all of them, which they will have to return signed.

      Depending on the semen quality evaluated in the diagnostic sample within the usual practice,
      in the laboratory the participants will be divided into 2 groups according to the WHO
      reference values in terms of sperm concentration and percentage of progressive motility:

        -  Group A (Normozoospermics): ≥15 mill / ml and> 32% progressive mobility.

        -  Group B (Non-normozoospermic): <15 mill / ml and <32% progressive mobility. The study
           will consist of 2 years. The first year will be used to collect all the diagnostic
           seminal samples from donor candidates, and the second year will be used in its first
           months to analyze the microbiome by extracting DNA from ejaculates, amplifying bacterial
           DNA with targeted primers. to the bacterial 16S rRNA gene regions, sequencing, library
           preparation and bioinformatic analysis.
    

Intervention name(s): Microbiome analysis
Intervention type(s): Other
Intervention description(s): Evaluate the bacterial composition in sperm from the different groups
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will include those donor candidates who come to undergo the diagnostic
        spermiogram within the usual practice and who have previously undergone an informative
        visit about the donation program and have been accepted for their profile and anamnesis
        regarding their family history and of health.
      
Keywords: Microbiome; Semen
Bundang Rehabilitative Impact Study of the Elbow Epicondylitis
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to assess the safety and effect of polydeoxyribonucleotide(PDRN) on the lateral
      epicondylitis with ultrasonography-guided injection of the PDRN or dextrose solution.

      Condition: lateral epicondylitis

      Intervention Drug: polydeoxyribonucleotide, PDRN Drug: dextrose solution, 15% as
      prolotherapy, active control

      Phase 4

      Study type: Interventional

      Study design: Treatment, Parallel Assignment, Double Blind((Subject, intervention performer,
      Investigator, Outcomes Assessor), Randomized, Safety/Efficacy Study

      Official Title: Safety and Effects of PDRN(polydeoxyribonucleotide) Injection in Patient with
      elbow epicondylitis in randomized double-blind active-control comparative study

      Estimated Enrollment: 40
    

Detailed description: 
      Detailed Description:

      40 patients that meet the inclusion criteria on screening test are assigned to one of two
      groups(PDRN group or 15% dextrose active control group) by randomization. They take the three
      times of the ultrasonography-guided injections for four weeks(0,2,4 weeks) under
      double-blind. PDRN group take ultrasonography-guided 3ml PDRN injection for the lesion( tear
      or tendinosis about extensor carpi radialis brevis, extensor digitorum communis, radial
      collateral ligament ) of lateral epicondylitis for 4 weeks. Active control group takes the
      15% dextrose solution, 3ml for same procedure. The main outcome variables are measured at 0,
      6 weeks and 3 months after 1st injection as starting point and compared differences from
      baseline to 3 month as primary end points within each group or between both group.
      Polydeoxyribonucleotide is verified whether it has the safety and effect on lateral
      epicondylitis with comparing to prolotherapy.
    

Intervention name(s): 3ml-Rejuvinex; 3ml-15%-dextrose solution
Intervention type(s): Drug; Drug
Intervention description(s): They take the three times of the ultrasonography-guided 3ml-Rejuvinex as a PDRN group for four weeks(0,2,4 weeks) under double-blind.; They take the three times of the ultrasonography-guided 3ml-15%-dextrose solution injections as a Dextrose group for four weeks(0,2,4 weeks) under double-blind.
Other intervention name(s): PDRN (Polydeoxyribonucleotide) sodium; 15% dextrose and 0.2% lidocaine solution, mixed, total 3ml; as prolotherapy
Intervention MeSH terms: Lidocaine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tennis elbow; Polydeoxyribonucleotides; Prolotherapy; Randomized controlled trial; Visual analogue scale; disability; ultrasonography
Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis
Condition: Allergy
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens
      compared with placebo for reduction of symptoms and rescue medication usage in children.
    


Intervention name(s): 300 IR grass pollen allergen extract tablet; Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): One sublingual tablet daily during 4 months before pollen season and during pollen season; One sublingual tablet daily during 4 months before pollen season and during pollen season
Other intervention name(s): Sublingual immunotherapy tablet; Sublingual placebo tablet
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sublingual immunotherapy; Grass pollen tablet; Allergic rhinoconjunctivitis