bioihbjkbjnl/mcl2 huggingface dataset:
Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer
Condition: Breast Cancer; Hot Flashes; Menopausal Symptoms
MeSH terms: Breast Neoplasms; Hot Flashes
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Hormone replacement therapy may be effective in managing the hot flashes and/or
      vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer.

      PURPOSE: Randomized phase III trial to determine the effectiveness of hormone replacement
      therapy in managing hot flashes and/or vaginal symptoms in postmenopausal women who are
      receiving tamoxifen for breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of hormone replacement therapy in managing hot flashes and
           menopausal vaginal symptoms in postmenopausal women with a history of node-negative
           invasive carcinoma or ductal carcinoma in situ of the breast who are receiving adjuvant
           tamoxifen.

        -  Determine the effect of this regimen on blood coagulation and lipid profiles in these
           patients.

        -  Determine the quality of life of patients treated with this regimen.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are stratified according to prior hysterectomy (yes vs no), symptom complex (vasomotor vs
      vaginal vs both), duration of hot flashes (less than 1 year or no hot flashes vs 1 year or
      more), and average daily number of hot flashes (less than 10 or none vs 10 or more). Patients
      are randomized to one of two treatment arms.

        -  Arm I: Patients who have not undergone prior hysterectomy receive oral
           medroxyprogesterone once daily for 6 months. If, after 1 month, symptoms do not resolve,
           patients receive oral conjugated estrogens once daily in addition to medroxyprogesterone
           for 5 months. Patients who have undergone prior hysterectomy receive oral conjugated
           estrogens once daily for 6 months.

        -  Arm II: Patients receive oral placebo once daily for 6 months. Quality of life is
           assessed at baseline and months 1, 2, 3, and 6.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this
      study within 12 months.
    

Intervention name(s): conjugated estrogens; medroxyprogesterone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone; Estrogens; Estrogens, Conjugated (USP)
Allocation: Randomized
Masking: Double
Primary purpose: Supportive Care
Keywords: stage I breast cancer; stage II breast cancer; breast cancer in situ; ductal breast carcinoma; hot flashes; menopausal symptoms
The Effect of Exercise on Serum Levels of Collagen and Proteoglycan in Patients With Knee Osteoarthritis (EFEX-OA-01)
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Aim of EFEX-OA-01: To explore how running, cycling and resting acutely influence levels of
      collagen and proteoglycan in patients with osteoarthritis knee and in young healthy subjects,
      as reflected by changes in serum and urine biochemical markers originating from joint related
      collagens and proteoglycans.
    


Intervention name(s): Ergometer Cycling followed by treadmill running; Treadmill Running followed by ergometer cycling; Rest
Intervention type(s): Other; Other; Other
Intervention description(s): The participants undergo ergometer cycling, treadmill running and rest.; The participants undergo treadmill running, ergometer cycling and rest.; The participants undergo ergometer cycling, treadmill running and rest.
Other intervention name(s): Exercise; Exercise; Non Exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomized to an order of exercise-intervention: cycling, running. This will be followed by a resting intervention. Interventions are planned 1 week apart.
Blood will be sampled before, immediately after and again at 1, 2, 3 and 24 hours after intervention start. Spot urine is sampled before, after and the next day.
Masking: None (Open Label)
Primary purpose: Basic Science
Stepping Stones and Creating Futures Intervention Pilot
Condition: Physical Violence; Sexual Violence; Livelihoods
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a shortened interrupted time series pilot evaluation over a twelve month period to
      evaluate whether the combined Stepping Stones and Creating Futures intervention can reduce
      men's perpetration of IPV and women's experience of IPV, strengthen livelihoods and reduce
      gender inequality.
    


Intervention name(s): Stepping Stones and Creating Futures
Intervention type(s): Behavioral
Intervention description(s): 21 session intervention, comprising of 10 Stepping Stones sessions focused on gender, relationships and communication. 11 Creating Futures sessions focused on livelihoods.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Estradiol and Testosterone Levels in Seminal Plasma of Men With Non-obstructive Azoospermia
Condition: Non-obstructive Azoospermia With Testicular Biopsy for Spermatozoa Extraction
MeSH terms: Azoospermia
Study type: Observational

Summary: 
      Estradiol and Testosterone are two important hormones for the regulation of an effective
      spermatogenesis in human testis. The evaluation of levels of estradiol and testosterone in
      seminal plasma of men with non-obstructive azoospermia may be a predictive test before
      surgical testicular biopsy to determine the chance of a positive sperm extraction to use for
      ICSI.
    

Detailed description: 
      The aim of this study is to compare the levels of esttradiol and testosterone in seminal
      plasma of men with non-obstructive azoospermia. Indeed, for these patients, none biological
      test allows to predict a positive sperm extraction before the surgical testis biopsy is
      performed. Since the involvement of estradiol and testosterone in the regulation of
      spermatogenesis, the measurement of these hormones in seminal plasma may be a predictive tool
      for these men before testis biopsy.
    

Intervention name(s): ESTRADIOL
Intervention type(s): Other
Intervention MeSH terms: Estradiol
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        azoospermia
Footbaths With Ginger, Mustard & Warm Water Only in Female Adolescents With & Without Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      A randomized, controlled, three-arm study to investigate the effects of footbaths with
      ginger, mustard or warm water alone in female, adolescent patients with Anorexia nervosa and
      in healthy, female adolescents on psychophysiological parameters.
    

Detailed description: 
      In a cross-over study design, the subjects (21 female patients with Anorexia nervosa, 20
      healthy, female controls) receive footbaths with either ginger, mustard or warm water alone
      in a randomized order with a wash-out period of at least 1-3 days. The effects of each
      intervention on the objective warmth generation are measured by infrared thermography,
      whereas the subjective warmth perception is determined by the 'Herdecke warmth perception
      questionnaire'. All parameters are determined at specified times (t1 = right before, t2 =
      right after and t3 = 10 minutes following the footbath), which enables an evaluation based on
      pre-post-comparisons. The statistical analysis comprises analyses of variances based on
      linear mixed effects models (after checking for carry-over effects).
    

Intervention name(s): Warm water; Mustard; Ginger
Intervention type(s): Other; Other; Other
Intervention description(s): Footbaths were prepared with 12 liters of warm water (40 °C); 12 l footbath with warm water (40 °C) and 80 g mustard flour (Sinapis nigrea semen plv.); 12 l footbath with warm water (40 °C) and 80 g ginger flour (Zingiberis rhizoma plv.)
Other intervention name(s): Sinapis nigrea semen; Zingiberis rhizoma
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Malabsorption as a Cause of Iron Treatment Failure in Infants
Condition: Iron Deficiency; Malabsorption
MeSH terms: Malabsorption Syndromes; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Infants should receive prophylacatic iron supplementation since age 4 months till one year.
      Patients suffering from malabsorption, mainly Giardia infestation may develop iron deficiency
      resistent to further iron treatment. The purpose of this study is to assess the incidence of
      malabsorption in those infants and to examine the results of empiric treatment with
      metronidazole.
    


Intervention name(s): Metronidazole; Blood tests
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Metronidazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Iron deficiency; Malabsorption; Giardiasis
Communicating Objective Risk for Personalized Decision Making About Mammography
Condition: Breast Cancer
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of objective risk information about breast
      cancer and mammography outcomes using a randomized control trial. Women between the ages of
      35 and 49 will receive information about their personal risk for breast cancer and be
      randomly assigned to receive data about a woman who should be screened, data about the
      potential outcomes of screening, or data about breast cancer deaths. Two presentation formats
      will be tested and compared.
    

Detailed description: 
      This study will compare alternative strategies for the presentation of individualized
      information about the risks and benefits of mammography screening. The purpose of this study
      is to understand how objective risk information influences outcomes including behavioral
      intentions, attitudes about mammography, and emotional responses.

      After participants view objective risk information, a post-test survey will measure outcome
      variables including behavioral intentions, knowledge, and emotional responses.

      After reading information based on their condition, study participants will be asked to
      complete a series of questions to measure their reactions based on their condition.
      Specifically, the investigators will be measuring the following dependent variables (primary
      outcomes): behavioral intentions to receive mammograms, attitudes about mammography,
      subjective norms about mammography and breast cancer screening, knowledge about mammography
      outcomes and screening recommendations, and emotional responses to the material including
      psychological reactance. These outcomes will be measured using self-reported questionnaire
      items.

      In this project, the investigators will compare alternative communication strategies to
      determine which strategy or strategies result in the greatest level of understanding. The
      investigators also will examine if the various strategies differentially affect the primary
      outcomes listed above.
    

Intervention name(s): Decision Aid
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Other
Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the safety and effectiveness of an investigational study drug (called
      CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.
    


Intervention name(s): CTP-543 matching placebo; CTP-543
Intervention type(s): Drug; Drug
Intervention description(s): Administered as tablets.; Administered as tablets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alopecia; Hair loss; Hair disease; CTP-543
Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA
Condition: Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis; Juvenile Rheumatoid Arthritis; Avascular Necrosis of Bone
MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Juvenile; Osteonecrosis; Necrosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the clinical performance of the rotating platform
      and fixed bearing implants in patients undergoing primary total knee replacement. Outcome
      scoring and radiographic assessment will be the methods used to evaluate performance.
    

Detailed description: 
      This study will evaluate the clinical performance of rotating platform and fixed bearing knee
      implants. This will be done by obtaining a series of primary total knee replacements.
      Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee
      System or the P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System and assignment is
      randomized.
    

Intervention name(s): Total Knee Replacement; Total knee replacement
Intervention type(s): Device; Device
Intervention description(s): Rotating Platform (RP) Cruciate Retaining Knee System; Fixed Cruciate Retaining Knee System
Other intervention name(s): P.F.C.® Sigma™ RP Cruciate Retaining Knee System; P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
MIND Diet Intervention and Cognitive Decline
Condition: Cognitive Decline; Dementia; Alzheimer Disease; Vascular Dementia
MeSH terms: Alzheimer Disease; Dementia; Dementia, Vascular; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Phase III randomized controlled trial designed to test the effects of a 3-year intervention
      of the MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) on cognitive
      decline and brain neurodegeneration among 600 individuals 65+ years without cognitive
      impairment who are overweight and have suboptimal diets.
    

Detailed description: 
      Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) is a Phase III
      randomized controlled trial designed to test the effects of a 3-year intervention of a hybrid
      of the Mediterranean and DASH diets, called MIND, on cognitive decline among 600 individuals
      65+ years without cognitive impairment who are overweight and have suboptimal diets. The
      proposed MIND diet is a hybrid of the Mediterranean and DASH diets but with selected
      modifications based on the most compelling evidence in the diet-dementia field. The MIND diet
      has the same basic components of the DASH and Mediterranean diets, such as emphasis on
      natural plant-based foods and limited animal and high saturated fat foods, but uniquely
      specifies green leafy vegetables and berries as well as food component servings that reflect
      the nutrition-dementia evidence. The trial will employ a parallel group design comparing the
      effects on cognitive outcomes of the MIND intervention diet plus mild caloric restriction for
      weight loss to the control diet, usual diet with mild caloric restriction for weight loss.
      Biological effects of the MIND diet will be assessed by measurement of brain macro- and
      micro-structural integrity in 300 randomly selected participants. Other biochemical markers
      will be assessed in the entire cohort of 600 participants, including: plasma Abeta 42/Abeta
      40, brain-derived neurotrophic factor (BDNF) and plasma markers of oxidative stress and
      inflammation. In addition, the trial will examine potential effect mediators and modifiers by
      a number of cardiovascular risk factors, AD biomarkers, and biological mechanisms. The
      proposed study has two clinical sites, one in Chicago (Rush University) and one in Boston
      (Harvard University), and centralized laboratories for data coordinating and analyses
      (Brigham & Women's Hospital), neuroimaging analyses (Rush University), and specialized
      laboratories for tissue biochemical analyses.
    

Intervention name(s): MIND Diet; Mild Weight Loss
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 3-year dietary counseling to adhere to the MIND diet and for mild weight loss; 3-year dietary counseling to reduce calorie intake by 250 kcal/day for mild weight loss
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Omega 3/6 Fatty Acids for Reading in Children
Condition: Reading Ability
Study type: Interventional

Summary: 
      The primary objective was to assess whether supplementation of Omega 3/6 fatty acids improves
      mainstream schoolchildren's reading ability. The secondary objective was to assess whether
      Omega 3/6 improves cognitive functions such as attention, memory, learning,
      language/communication, problem solving and social ability.This was a 3-month randomised,
      double-blind, placebo-controlled study followed by one-way crossover (placebo to active
      treatment) for an additional 3 months. Mainstream schoolchildren aged 9-10 years were
      initially randomised to receive three Omega 3/6 capsules twice daily or identical placebo.
      All outcome measures were assessed at baseline, 3 months and 6 months. The primary outcome
      measure was the LOGOS test, a comprehensive test battery for evaluating reading abilities.
      Secondary outcome measures were the parent-rated Attention Deficit Hyperactivity Disorder
      (ADHD) Rating Scale-IV, 5-15 scale (domains of learning, memory, language/communication and
      problem solving); Social and Communication Disorders Checklist (to evaluate social ability)
    

Detailed description: 
      This was a 3-month randomized, double-blind, placebo-controlled study (Period 1) followed by
      one-way crossover (placebo to active treatment) for an additional 3 months (Period 2).
      Participants were randomized to receive three Omega 3/6 capsules twice daily (corresponding
      to a daily dose of 558 mg EPA, 174 mg DHA, and 60 mg gamma-linolenic acid) or identical
      placebo capsules (palm oil). All daily doses were taken at home supervised by the parents.
      All outcome measures were assessed at baseline and at the 3- and 6-month follow-up visits.
      The participants were mainstream schoolchildren in the 3rd school year (aged 9-10 years).
      Exclusion criteria were continuous supplementation of Omega-3 fatty acids for periods longer
      than 1 month during the previous year, significant medical conditions (e.g. diabetes,
      epilepsy), intellectual disability, attention-deficit hyperactivity disorder (ADHD)
      diagnosis, psychoactive medication, or substance use.
    

Intervention name(s): Omega 3/6 fatty acids; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Three Omega 3/6 capsules twice daily; Three placebo capsules twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clearblue® Advanced Ovulation Test User Study
Condition: Trying to Conceive Population
Study type: Interventional

Summary: 
      The Clearblue® Advanced Ovulation Test is designed for home use by women who are either
      planning or trying for a pregnancy.

      The purpose of this protocol is to demonstrate that lay-users representative of the target
      user population are able to use the product in the intended user environment.
    

Detailed description: 
      The Clearblue Advanced Ovulation Test is designed for home use by women who are trying to get
      pregnant now or in the near future. It identifies those days in a woman's cycle on which
      intercourse is most likely to lead to conception.

      The product defines three phases of fertility through urine hormone measurement: Low (small
      chance of conceiving), High (increased chance of conceiving) which is achieved by the
      detection of a rise in the level of estrone-3-glucuronide and Peak (highest chance of
      conceiving) which provides an early warning of impending ovulation through detection of the
      luteinising hormone surge which precedes it by 24 - 36 hours.

      This protocol aims to demonstrate the successful usage of the Clearblue Advanced Ovulation
      Test product by lay-users in the intended environment.

      Elements of system usability, product satisfaction and ease of use will be used to assess
      overall product performance in lay-user hands.

      Lay users will be required to user the product according to the instructions for use for a
      mimimum of 1 complete menstrual cycle after which they will be required to provide feedback
      on product use.

      A usability scale which focusses on providing subjective feedback from users. This is a
      simple ten-item attitude Likert scale which each volunteer will complete after 4 weeks of
      product use. The primary endpoints of this study will focus on the use of this scoring scale
      to determine the usability of the product in lay-user hands.
    

Intervention name(s): ovulation test use
Intervention type(s): Diagnostic Test
Intervention description(s): Normal use of The Clearblue® Advanced Ovulation Test according to Information for use instructions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and CS-866 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug
      interaction between rosuvastatin and CS-866 in healthy male volunteers.
    


Intervention name(s): Cresto; Olmetec; Cresto, Olmetec
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet, 20mg; tablet, 40mg; tablet, 20mg and 40mg
Intervention MeSH terms: Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)