bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Pelvic Floor Muscle Training Included in General Fitness Classes During Pregnacy
Condition: Pregnancy; Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      To investigate the effect of pelvic floor muscle training taught in a general exercise class
      during pregnancy to prevent urinary incontinence in nulliparous continent pregnant women.
    

Detailed description: 
      Pregnancy and childbirth are known risk factors for development of female urinary
      incontinence (UI). Studies have found that Pelvic Floor Mucle Trainig (PFMT) is effective in
      preventing and reducing UI during pregnancy and after childbirth. However, in a recent study,
      no effect was found when PFMT were taught in a general fitness class without former palpation
      of the pelvic floor muscles (Bo y Haakstad, 2011).
    

Intervention name(s): Exercise classes with pelvic floor muscle training
Intervention type(s): Other
Intervention description(s): Supervised exercise classes which included pelvic floor muscle training. 3 sessions per week. 55-60 min per session, with 10 minutes of pelvic floor muscle training. At least during 22 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Urinary incontinence; Pregnancy; Pelvic floor muscle training
Effects of Footstrike Transition on Tibial Stress Fracture Risk
Condition: Tibial Stress Fracture
MeSH terms: Fractures, Bone; Fractures, Stress
Study type: Interventional

Summary: 
      Biomechanical literature suggests that runners who utilize a mid or forefoot strike pattern
      may suffer from a reduced incidence of chronic injuries compared to a rearfoot strike. This
      investigation examined the effects of a 10-week footstrike transition intervention on tibial
      stress fracture risk in runners.
    


Intervention name(s): Footstrike modification; Control
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Changes in Stem Cells of the Colon in Response to Increased Risk of Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Colorectal cancer is a common disease worldwide. Increasing evidence is demonstrating that
      colorectal cancers arise from 'cancer stem cells.' Stem cells in the colon reside at the
      bottom of thousands of microscopic crypts throughout the wall of the colon. They create all
      the cells lining the bowel wall. These cells are created in the base of the crypt and ascend
      to the top acquiring the characteristics of mature cells of the bowel wall as they ascend.

      It is now thought that colorectal cancer cells arise from stem cells where the genetic
      material regulating growth and division of the stem cell has become defective. This leads to
      unregulated production of cells which in turn have defective genetic information and cancer
      formation.

      Prior studies have demonstrated that the earliest changes before a cancer develops are
      changes in cellular proliferation. Now that reliable markers to identify stem cells have been
      found, the researchers aim to investigate stem cell numbers and changes in distribution in
      those at normal risk of colorectal cancer and those at higher risk. The researchers
      hypothesise that changes in cellular proliferation at the top of the crypt in individuals at
      higher risk of colorectal cancer are due to a change in the number of stem cells in the crypt
      base.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients referred for lower gastrointestinal (GI) endoscopy at a participating centre
        will be considered for inclusion. Patients with a previous adenomatous polyp resection
        under surveillance will be considered for inclusion to the polyp group. Patients with
        ulcerative colitis under surveillance will be considered for inclusion to the ulcerative
        colitis group.
      
Biospecimen description: 
      Rectal pinch biopsies - x 9 (10 cm from anal verge)
    
Keywords: Colorectal cancer; Stem cells; Ulcerative colitis; Polyps
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to confirm the efficacy and the safety of Avanafil 100mg, 200mg
      or placebo administered orally for 12 weeks in patients with erectile dysfunction. The
      efficacy is evaluated by IIEF, SEP Q2 and Q3 and GEAQ and the safety is evaluated by
      laboratory tests, vital signs, physical examination and adverse events.
    


Intervention name(s): Avanafil; Avanafil; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 tablets(Avanafil 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse; 2 Tablets(Avanafil 200mg tablet + Placebo 100mg tablet), 30 minutes before sexual intercourse; 2 Tablets(Placebo 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Study to Examine the Effects of an Experimental Toothpaste Compared to a Regular Fluoride Toothpaste on Breath Odor in a Population With Gingivitis
Condition: Halitosis
MeSH terms: Gingivitis; Halitosis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy of an experimental dentifrice,
      containing 0.454 percent (%) stannous fluoride and 0.3% zinc chloride, to reduce oral
      malodor, compared to a marketed regular fluoride dentifrice after 3 weeks twice daily
      brushing in a population of clinically diagnosed gingivitis.
    

Detailed description: 
      This will be a single center, single blind (to the examiners undertaking the oral malodor
      assessments), randomized (stratified by the participant's sex), controlled, two arm parallel
      study in volunteers with clinically diagnosed gingivitis and oral malodor. The study will
      evaluate the clinical efficacy of an experimental dentifrice containing 0.454% stannous
      fluoride and 0.3% zinc chloride to reduce oral malodor after 3 weeks of twice-daily use
      compared to a regular reference dentifrice. Sufficient participants will be screened to
      randomize approximately 106 participants to study treatment (approximately 53 per treatment
      group) to ensure approximately 100 evaluable participants complete the study.
    

Intervention name(s): Experimental Dentifrice; Reference Dentifrice
Intervention type(s): Other; Other
Intervention description(s): Dentifrice containing 0.454% stannous fluoride with 0.3% zinc chloride.; Standard fluoride dentifrice containing 0.243% sodium fluoride.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study of the Efficacy and Safety of SCH 619734 in Subjects With Chronic Cough From an Unknown Cause (Study P04888)
Condition: Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, crossover, single center study of SCH
      619734 in subjects with chronic cough from an unknown cause. Subjects will be randomized to
      receive SCH 619734 or placebo for 7 days with 7 days' follow-up. After a 6 week washout
      period, subjects will be crossed over to the other treatment. The primary objective is to
      evaluate the effectiveness of SCH 619734 in reducing cough reflex sensitivity as determined
      by a challenge with capsaicin, an agent that induces cough.
    


Intervention name(s): SCH 619734; Placebo Dose 1
Intervention type(s): Drug; Drug
Intervention description(s): SCH 619734 50-mg capsule each day orally. One week of treatment with 7 days' follow-up; 1 week of crossover treatment with 7 days' follow-up. A 6 week washout period separates treatments.; Matching placebo capsule each day orally. One week of treatment with 7 days' follow-up; 1 week of crossover treatment with 7 days' follow-up. A 6 week washout period separates treatments.
Other intervention name(s): Rolapitant
Intervention MeSH terms: Rolapitant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Age-related Normative Values for the Octopus 900 Perimeter
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine normal values of the visual field (VF), corrected
      for age- and reaction time (RT) using the Octopus 900 perimeter and semi-automated kinetic
      perimetry (SKP).
    


Intervention name(s): Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland)
Intervention type(s): Device
Intervention description(s): We used the following six combinations of Goldmann8,1 stimulus size, stimulus luminance and angular velocity: V4e (64mm², 103', 320cd/m²) at 5°/s, III4e (4mm², 25.7', 320cd/m²) at 5°/s, I4e (0.25mm², 6.45', 320cd/m²) at 2°/s (for the assessment of the blind spot), I3e (0.25mm², 6.45', 100cd/m²) at 5°/s, I2e (0.25mm², 6.45', 32cd/m²) at 3°/s, I1e (0.25mm², 6.45', 10cd/m²) at 3°/s, I1a (0.25mm², 6.45', 4cd/m²) at 2°/s .
The peripheral five isopters, consisting of 24 vectors (every 15° meridian), were presented in random order, while the innermost isopter (I1a) consisted of 12 vectors (every 30° meridian)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Norm values; semi-automated kinetic perimetry; isopters; mathematical model; luminance; test-retest reliability; deviation; age dependance; different age groups; Healthy subjects
Gastrointestinal Transit Times and Motility in Healthy Volunteers Obtained by Motilis-3D-transit
Condition: Gastrointestinal Motility; Total Gastrointestinal Transit Time; Segmental Transit Time; Gastric Emptying
Study type: Observational

Summary: 
      The purpose of this study is to describe gastrointestinal motility and transit times in
      healthy subjects by using Motilis 3D-Transit and to compare the total gastrointestinal
      transit time (GITT) to GITT obtained using radioopaque markers.

      The investigators end points are to measure the transit times through different segments of
      the gastrointestinal canal,e.g. gastric emptying, small intestine, total GITT.

      The study is descriptive and is designed to test and evaluate the usefulness of the Motilis
      3D-Transit system. The investigators hypothesize, that with the system transit times through
      different segments of the gastrointestinal canal can be measured.

      The design is made for evaluating the transit times, the inter-subject reproducibility and
      comparison with gold standard for colonic transit time measurement.

      The investigators have chosen to include 20 healthy volunteers.The study is descriptive and
      therefore power calculation is not needed.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Volunteers
      
Keywords: Gastrointestinal Motility; Transit time
Trial to Compare the Efficacy and Safety of F-627 and GRAN®
Condition: Breast Cancer
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Trial to Compare the
      Efficacy and Safety of Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion
      Protein (F-627) and Recombinant Human Granulocyte Colony Stimulating Factor (GRAN®) in the
      Prophylactic Treatment for Chemotherapy-Induced Neutropenia
    

Detailed description: 
      Protocol Number: SP11631 Study Stage: Phase III Study Population Female patients with breast
      cancer will be enrolled to receive at least 4 cycles of EC chemotherapy, that is: epirubicin
      100 mg/m2 and cyclophosphamide 600 mg/m2.

      Study Design: A multi-center, randomized, open-label, active-controlled phase III clinical
      trial Site Number: 14 sites(planned) , 12 sites(actual) Subject Number: 240
    

Intervention name(s): F-627
Intervention type(s): Biological
Intervention description(s): Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer
Condition: Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of
      veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant
      chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.
    


Intervention name(s): Cyclophosphamide; Placebo; Doxorubicin; Paclitaxel; Carboplatin; Veliparib; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Cyclophosphamide; Placebo for Carboplatin; Doxorubicin; Paclitaxel; Carboplatin; Veliparib; Placebo for Veliparib
Other intervention name(s): ABT-888
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Carboplatin; Doxorubicin; Veliparib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oncology; Triple negative breast cancer; German Breast Group - GBG 81; United States Oncology - 12152; National Surgical Adjuvant Breast and Bowel Project - B-56-I; Alliance - AFT-04; Grupo Español de Investigación en Cáncer de Mama - GEICAM/2014-02
A Study to Determine the Capacity of VAK694 When Combined With Allergen Immunotherapy to Bring About Specific Immune Tolerance
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether VAK694 when combined with subcutaneous
      immunotherapy leads to long term immune tolerance to allergen in individuals with seasonal
      allergic rhinitis.
    


Intervention name(s): VAK694; Alutard Avanz SQ; VAK694 placebo infusion; Alutard Avanz SQ; VAK694 placebo infusion; Saline
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Seasonal allergic rhinitis,; late phase response,; alutard avanz,; immunotherapy,; visual analogue scale,; mini rhinitis quality of life,; immune modulation
Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception
Condition: Oral Contraceptive
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the contraceptive efficacy of an oral contraceptive containing a combination of
      LNG 90 mg/EE 20 mg in a continuous-use regimen and to evaluate the safety compared to LNG 100
      mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen.
    


Intervention name(s): Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg
Intervention type(s): Drug
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Educational/Counseling/Training
Keywords: Oral Contraceptive
Developing and Testing of Culturally Adapted Cognitive Behavior Therapy (CaCBT) for Pashto Speaking Pakistanis and Afghans
Condition: Depression, Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      CBT for common mental disorders has a strong evidence base in both the USA and the UK. There
      are wider cultural and linguistic differences between Non Pashtun and Pashtun population of
      Pakistan and Afghanistan and there is evidence from research to suggest that CBT might need
      some adaptations when working with clients from non-western background. This study, thus,
      aims to culturally adapt CBT for common mental disorders for Pashto speaking population in
      Pakistan and Afghanistan and to test the effectiveness of this adapted CBT through a small
      scale pilot study.

      The study will be carried out using mixed methods; quantitative and qualitative. Qualitative
      part will consist of structured interview with a minimum of 10-15 patients; carers; and
      mental health professionals, respectively, using the interview questionnaires. The data will
      be analysed by systematic content and question analysis which will identify the emerging
      themes and categories. The data will then be reorganized into wider themes and categories and
      written for guidelines to culturally adapt therapy manual for common mental disorders.

      Quantitative phase will be a RCT involving 40 patients (20 in each arm) to assess the
      effectiveness of a "CaCBT intervention" for Pashto speaking patients. All those who fulfill
      the diagnostic criteria of depressive episode or recurrent depressive disorder using ICD 10
      RDC, are living near or can easily travel to the psychiatry departments in Peshawar, will be
      included in the study.

      The intervention group of the RCT will receive CaCBT intervention in addition to the
      treatment as usual (TAU) while the control group receives TAU. The assessment will be carried
      out at base-line and at the end of therapy (8-12 weeks). Bradford Somatic Inventory (BSI),
      Hospital Anxiety and Depression Scale (HADS) and Brief Disability Questionnaire (BDQ)/ WHO
      DAS will be used to measure somatic symptoms, anxiety, depression and disability due to
      physical and psychological problems, respectively. Schwartz Outcome Scale will be used at
      follow up to measure the outcome.
    


Intervention name(s): CaCBT; Medication/ Psychotherapy
Intervention type(s): Other; Other
Intervention description(s): Culturally Adapted Cognitive Behaviour Therapy; Medication/ Psychotherapy used as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Behavior Therapy; Depression; Anxiety; Pashto; Pakistani; Afghan
Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects
Condition: Heart Defects
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this project is to investigate the feasibility of using a home-based,
      parent-delivered model for providing neurodevelopmental rehabilitation programmes to infants
      who have had surgery for a complex heart defect.
    

Detailed description: 
      Neurodevelopmental deficits are a common morbidity among children who receive surgical
      treatment for complex congenital heart defects in infancy. Over 40% of children with complex
      heart defects will have neurodevelopmental deficits that persist throughout childhood even
      after a successful surgical procedure in infancy1. These deficits are typically related to
      basic motor perceptual motor or visual motor skills. Problems integrating what is seen
      (visual perceptions) with body movement (motor skills) makes it difficult for children to
      participate in peer play and limits their ability to succeed in school, thereby having a
      significant impact on the child's quality of life.

      Traditional, therapist-delivered rehabilitation programmes to address these delays in
      neurodevelopment have not previously been attempted. It would be difficult to provide direct
      rehabilitation programmes to these patients given that their defects are rare and few
      patients are located within the same geographical area. Home-based, parent-delivered
      rehabilitation programmes have previously been shown to be effective at improving the motor
      skills of school-age children with complex heart defects5. Since a home-based parent
      delivered model would enable the participation of infants regardless of geographic location,
      the feasibility of using such a model for delivering neurodevelopmental rehabilitation should
      be investigated.
    

Intervention name(s): Home-based neurodevelopmental rehabilitation programme
Intervention type(s): Behavioral
Intervention description(s): Participation in the study will require the parent and child to attend two assessment visits in addition to completing a series of parent and infant activities on a daily basis throughout the 10-week intervention period. The parent-led activities will include activities such as walking with the child, stacking blocks, rolling a ball to the child, hiding a toy under a blanket for the child to find, encouraging the child to kick a rattle while the child is lying on his/her back, or crawling or rolling in different directions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pediatrics; Heart Defects; Neurodevelopmental deficit; Neurodevelopmental Rehabilitation