bioihbjkbjnl/mcl2 huggingface dataset:
Age-related Changes in Ovarian Follicular Wave Dynamics
Condition: Aging
Study type: Observational

Summary: 
      The investigators hypothesize that age-related changes in the number and growth dynamics of
      ovarian follicles will be associated with changes in hormone levels and corresponding changes
      in musculoskeletal health.
    

Detailed description: 
      The following hypotheses will be tested:

        1. Differences in ovarian follicular wave dynamics will be detected in women of different
           ages;

        2. The numbers and patterns of ovarian follicle waves in women are repeatable over multiple
           menstrual cycles;

        3. Differences in inhibin B, inhibin A, and AMH will be detected in women with 2 versus 3
           or more follicular waves

        4. Differences in FSH, LH, progesterone, inhibin B, inhibin A, and AMH detected in MRA and
           LRA2 women, will change with the numbers of follicles and waves detected;

        5. 'Luteal out of phase events' (aka LOOP cycles) will be more prevalent in LRA2 versus MRA
           women, and will represent major anovulatory waves and/or ovulatory waves;

        6. When compared to MRA group, LRA2 women will have lower bone mineral mass and areal
           density at the lumbar spine; reduced trabecular density at the distal radius and thinner
           cortices with lower cortical density at the radial and tibial shaft. Other bone outcomes
           will be similar between the groups;

        7. When compared to MRA group, LRA2 women will have lower total body lean mass, greater fat
           mass and less dense muscle tissue at the forearm and lower limb and lower hand grip
           strength.

        8. Reduced bone mineral mass, areal density, trabecular density, cortical density and hand
           grip strength in LRA2 versus MRA women will be associated with reduced follicle number,
           a greater prevalence of LOOP cycles, higher serum FSH and lower inhibin concentrations
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Seventy healthy women, exhibiting all inclusion criteria and no exclusion criteria will be
        enrolled in this study. Women will be grouped into 1 of the following age categories:

          1. . Mid-reproductive age (MRA): 18-35 years

          2. . Late reproductive age-1 (LRA1): 36-44 years

          3. . Late reproductive age -2 (LRA2): 45-55 years (this group will include women in the
             LRA, EMT and LMT groups, as previously characterized by STRAW)
      
Biospecimen description: 
      Serum samples are isolated and frozen for retrospective analyses.
    
Keywords: ovary; follicle; hormones; bone; muscle
Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine
      Sublingual (under the tongue) Spray compared with placebo in participants with postoperative
      pain after bunionectomy.
    


Intervention name(s): Buprenorphine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Buprenorphine sublingual spray delivered via single 100 μL spray; Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Post-Surgical Pain; Bunionectomy
Low Dose of Midazolam is Superior to Conventional Dose for Rapid Sequence Intubation in Emergency Department (ED)
Condition: Intubation
Study type: Interventional

Summary: 
      Midazolam has been used in rapid sequence intubation for a long time, and the recommended
      dose is 0.1mg/kg. In some studies, however, the reduced dose has been used with the concern
      of hemodynamic instability. We would like to investigate that the low dose midazolam could be
      used rather than the standard recommended dose, and also compare it to the etomidate,
      recently used sedatives, with respect to the side effects and the easy performance of
      intubation.
    


Intervention name(s): Low dose midazolam
Intervention type(s): Drug
Intervention MeSH terms: Midazolam
Primary purpose: Treatment
Keywords: intubation
Study To Investigate If Embody's Retinol Gummies Improve The Early Signs Of Skin Aging And Overall Skin Health
Condition: Acne, Adult
Study type: Interventional

Summary: 
      The Embody retinol study is a single-arm clinical trial on skin aging prevention and adult
      acne. The purpose of this study is to determine the effect of a retinol gummy in adults aged
      18-45 on skin aging and overall skin health.
    

Detailed description: 
      Embody has developed a retinol gummy with the aim to improve the appearance of early signs of
      aging, such as fine lines, dark spots, and sagging. Embody's retinol gummy has also the goal
      to reduce the overall frequency of adult acne and an improvement of overall skin health by
      promoting hydrated, brightened skin. The study aims to collect self-reported outcomes and
      photographic images to understand the assessment of the efficacy of treatment from the
      participant's perspective, and if participants see an improvement in their fine lines,
      wrinkles, dark spots, and sagging.
    

Intervention name(s): Retinol gummy
Intervention type(s): Dietary Supplement
Intervention description(s): Participants take one retinol gummy per day
Intervention MeSH terms: Vitamin A
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: skin aging; adult acne
Tea Consumption and Cognitive Performance in the Very Old
Condition: Cognition
Study type: Observational

Summary: 
      Studies have found a beneficial effect of tea consumption on the reduction of risk of
      cognitive impairment and dementia in older aged populations. However, there is a paucity of
      data on these associations in the very old defined as individuals aged 85 years and over.
      Therefore, we hypothesized that higher tea consumption was associated with better global and
      domain-specific cognitive function. We investigated the relationship between tea consumption
      in the very old and measures of global cognitive function, memory, attention and psychomotor
      speed.

      The Newcastle 85+ Study was a longitudinal (5-years), population-based cohort study of
      individuals aged 85+ years in North East England, United Kingdom. The final sample included
      676 community-dwelling and institutionalized men and women recruited through general medical
      practices.

      Baseline tea consumption was assessed through a 2x24-hr multiple pass recall and longitudinal
      measures of global and domain specific (memory, speed and attention) cognitive function
      through the standardized mini-mental state examination and the cognitive drug research
      system. Linear mixed models, controlling for demographic (e.g. age, sex and education) and
      health variables were used to determine whether tea consumption was protective against
      cognitive decline.
    


Intervention name(s): Cognitive performance and cognitive decline
Intervention type(s): Other
Intervention description(s): Assess the global and domain specific (memory, speed and attention) cognitive function at baseline and over 5 years in the high vs. low/moderate tea consumption groups
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community-dwelling and institutionalized men and women recruited through general medical
        practices in North East England, UK (n=676) and born in 1921 (85 years old at baseline).
      
Keywords: tea; cognition; very old; Newcastle 85+; epidemiology
A Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)
Condition: Anemia of Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase IV, randomized, active-controlled, open-label, parallel design, multicenter
      prospective study to evaluate the effect of roxadustat versus rHuEPO treatment on the
      gastrointestinal (GI) iron absorption in patients with anemia of Stage 4 and Stage 5 CKD.
    

Detailed description: 
      This is an open-label study, after eligibility confirmation patients will be randomized in a
      1:1 ratio to either roxadustat or rHuEPO arms for 2 weeks.

      The study will enroll eligible dialysis and non-dialysis patients ≥18 years of age, who have
      anemia of CKD, and are either dialysis-dependent (DD) and on a stable dose of rHuEPO within 4
      weeks prior to screening, or are non-dialysis-dependent (NDD) and are being treated with
      rHuEPO (ie, on a stable dose of rHuEPO within 4 weeks prior to screening), or are rHuEPO
      -naïve at the time of screening.

      Each patient will be contacted before the first Screening Visit (Visit 1) for the symptoms of
      coronavirus disease of 2019 (COVID-19) and for any contact with COVID-19 positive person
      within the past 14 days.

      For each patient, the duration of participation in the study will be approximately 8 to 9
      weeks divided into 3 periods: Screening Period (approximately 2-3 weeks); Treatment Period (2
      weeks) and Post-Treatment Follow-up Period (4 weeks).
    

Intervention name(s): Roxadustat; rHuEPO
Intervention type(s): Drug; Drug
Intervention description(s): The starting dose of roxadustat will be in accordance with the China package insert, and will depend on the body weight of the patient: 100 mg (45 to < 60 kg) or 120 mg (≥ 60 kg) in patients on dialysis; 70 mg (40 to < 60 kg) or 100 mg (≥ 60 kg) in non-dialysis patients.; The starting dose of rHuEPO will be in accordance to the dosage approved in rHuEPO China package insert (patients on weekly dose of 6000 IU [dosing will BIW], and patients on weekly dose of >6000 IU [dosing will TIW]) and on patient's haemoglobin levels.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recombinant Human Erythropoietin; Roxadustat; Coronavirus disease of 2019; Chronic kidney disease; Anemia
Feasibility Study: Evaluation of the Ulthera® System for Treatment of Abdominal Tissue
Condition: Skin Laxity; Skin Crepiness
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      Enrolled subjects will receive one UltherapyTM treatment on the abdomen. Follow-up visits
      will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment,
      immediately post-treatment, and at each follow-up visit.
    

Detailed description: 
      This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the
      Ulthera® System for improving laxity/crepiness and texture of abdominal tissue. Changes from
      baseline in the laxity, crepiness and texture of abdominal skin will be assessed at each
      study follow-up visit. Global Aesthetic Improvement Scale scores, assessments of dermal
      thickness, and patient satisfaction questionnaires will also be obtained.
    

Intervention name(s): Ulthera System Treatment
Intervention type(s): Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin
Other intervention name(s): Ultherapy™
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
Effect of High-intensity Low-volume Training on Insulin Sensitivity in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      High intensity interval training is applied for several diseases.

      Hypothesis: High intensity interval training improves insulin sensitivity in patients with
      type 2 diabetes.
    

Detailed description: 
      Type 2 diabetes mellitus is a multifactorial metabolic disease that is characterized by
      reduced insulin sensitivity and insulin production leading to impaired glucose tolerance.
      Overweight and low physical activity are the main risk factors for the development of type 2
      diabetes. Increased physical activity has shown to improve insulin sensitivity, hence,
      exercise plays a significant role in the prevention and therapy of type 2 diabetes. This
      study aims at investigating the acute and chronic effects of high-intensity low-volume
      training, that consists of brief bursts of very vigorous exercise separated by recovery
      periods, on metabolic function in patients with type 2 diabetes, people at high risk for the
      disease and healthy, lean individuals. Study participants take part in 30 min training
      session three times a week for a period of 12 weeks. Participants are studied on four
      occasions, prior to the intervention, after an acute bout of exercise as well as after 6 and
      12 weeks of training in order to assess physical fitness, body composition, insulin
      sensitivity, energy metabolism in muscle, adipose tissue inflammation and neurological
      function. It is hypothesized that this type of exercise leads to significant improvements in
      insulin action and oxidative phosphorylation in muscle
    

Intervention name(s): High intensity interval training
Intervention type(s): Other
Intervention description(s): The intervention consists of 30 minute sessions of high-intensity interval training on a bicycle ergometer three times per week.
Training program: After 5 minutes of warm-up the subject cycles for 10 intervals of 60 s. at 90 % maximum effort separated 60 s at 20% maximum effort, based on a previously performed spiroergometry, followed by 5 minutes of cool-down.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: type 2 diabetes; exercise intervention; high intensity interval training
Long-Term Follow-up Safety of Clonidine Micropellets
Condition: Lumbosacral Radiculopathy
MeSH terms: Radiculopathy
Study type: Observational

Summary: 
      Long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months
      post injection.
    


Intervention name(s): Long-Term Safety Follow-up
Intervention type(s): Drug
Intervention description(s): STX-015-18-01 long-term safety follow-up
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Comprised of the first 100 subjects who completed all STX-015-18-01 study-related
        activities, age 18-70, male/female, reconfirmed eligible and signed informed consent.
The Impact of Lifestyle on Mental Health Among Young Men in the Gilgel Gibe Field Research Center, Ethiopia: Pilot Study
Condition: Common Mental Disorders (CMD); Psychotic Symptoms
MeSH terms: Mental Disorders
Study type: Observational

Summary: 
      Researchers of the three collaborating universities implement a pilot observational study in
      "Gilgel Gibe Field Research Center", a health and demographic surveillance system run by the
      Jimma University, Ethiopia. In this setting, the investigators plan to study risk factors in
      young men for the development of common mental disorders and psychotic symptoms and the
      stability of distinct symptoms of mental disorders in the community. The investigators will
      explore in particular the impact of lifestyle on mental health in young men, including the
      traditional habit of chewing khat leaves, which contain amphetamine-like cathinone.
      Furthermore, the investigators want to demonstrate the reliability and validity of
      assessments performed by trained local interviewers.
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention, observational study
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Young adult male inhabitants of the Gilgel Gibe field research center.
      
Biospecimen description: 
      Immunoassay test for the screening of khat alkaloids in urine.
A Study of Galcanezumab in Healthy Participants.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate how much galcanezumab gets into the body after
      it is given as an injection just under the skin by two different devices. This study will
      measure how much galcanezumab reaches the blood stream and will test how it affects
      calcitonin-gene related peptide (CGRP) in blood. Information about any side effects that may
      occur will be collected. The study will last about 20 weeks for each participant. Screening
      is required within 45 days prior to the start of the study.
    


Intervention name(s): Galcanezumab
Intervention type(s): Biological
Intervention description(s): Administered SC
Other intervention name(s): LY2951742
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison Study of Topical Acne Regimens
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effectiveness of two over the counter acne
      products in subjects with moderate severity acne vulgaris. The two products being compared in
      this study are Acne Free "Severe Acne Line" manufactured by University Medical Products, and
      Proactiv® manufactured by Guthy-Renker.
    

Detailed description: 
      You will receive a study drug for the 8 week study. No subject will be given a placebo (an
      inactive substance) during treatment.The study drugs (over the counter acne medications) have
      been previously tested and their safe use has been established. However, not all risks or
      side effects are known. In rare cases of allergy, side effects may be life threatening.The
      most common side effects of this study drug are:

        1. Dry skin

        2. Peeling skin

        3. Red skin

        4. Burning or tingling (temporary)
    

Intervention name(s): Acne Free, Proactiv
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Acne
Long-Term Follow-Up of Patients Undergoing Catheter Ablation
Condition: Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Study type: Observational

Summary: 
      The purpose of this study is to assess the long-term effects of catheter ablation procedures
      performed at the OU Medical Center.
    

Detailed description: 
      The purpose of this study is to assess the long-term effects of catheter ablation procedures
      performed at this institution, including recurrence of the ablated arrhythmia and any late
      complications.
    

Intervention name(s): Catheter Ablation
Intervention type(s): Procedure
Intervention description(s): Catheter Ablation of arrhythmias
Other intervention name(s): All approved ablation catheters; Investigational ablation catheters
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing catheter ablation at the OU Medical Center
      
Keywords: Arrhythmia; Catheter Ablation
Effect of CSII and CGM on Progression of Late Diabetic Complications
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to investigate whether the combination of insulin pump therapy
      and continued glucose monitoring (CGM) is superior to multiple daily insulin injections to
      prevent progression of albuminuria in patients with type 1 diabetes
    

Detailed description: 
      80 type 1 diabetic patients with kidney function (GFR > 45 ml/min), but with urine albumin
      excretion of at least 30 mg/day and HbA1c 7.5-13.0% are randomised to either multiple daily
      insulin injections (control group) or insulin pump therapy plus continued glucose monitoring
      (CGM) (intervention group). Patients must be in stable RAAS blockade before entering the
      study.

      Before the study is initiated all patients receive education in intensive diabetes treatment
      and self-care including carbohydrate counting.

      Patients return to the clinic after 1,3,6,9, and 12 months for measurement of urine albumine
      excretion, clinical examination including blood pressure, CGM sensor readings, four-point
      self monitored blood glucose (SMBG) profiles, blood samples and fulfillment of questionnaire
      to assess quality of life. At entry and after 12 months, eye fundus foto, 24-hour blood
      pressure, GFR, and carotis intima media thickness (CIMT)are also evaluated.
    

Intervention name(s): Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM); Multiple daily insulin injections (MDI)
Intervention type(s): Device; Other
Intervention description(s): Randomization to 12 months with CSII plus CGM; Randomization12 months therapy with MDI
Other intervention name(s): CSII; CGM; Medtronic MiniMed Paradigm REAL-Time System; Medtronic MiniMed Paradigm Veo; Sensor augmented insulin pump therapy; Human insulin; Insulin analogues
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes mellitus; Albuminuria; Late diabetes complications; CSII; CGM; Glycaemic control