bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Controlled Trial Comparing the Effect of Pelvic Floor Muscle Training
Condition: Pelvic Floor Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      Aim: To determine the effects of pelvic floor muscle training (PFMT) in women with a single
      delivery route. Pregnancy and delivery route alter the pelvic floor muscle strength and are
      considered risk factors for urinary incontinence and genital dystopias. Methods: A Randomized
      controlled clinical trial with two hundred ninety-seven women aged 35 to 45 years old were
      selected for functional assessments of their pelvic floors by vaginal digital palpation and
      perineometry. One hundred sixty-five (69.7%) exhibited muscle strength deficits and were
      included in the clinical trial. The participants were distributed into two groups based on
      the delivery route (A, vaginal delivery and B, cesarean delivery) and were then randomly
      subdivided into Groups A1 (n = 44) and B1 (n = 42), who performed PFMT, and Groups A2 (n =
      39) and B2 (n = 40), who did not undergo muscle training. The PFMT involved perineal
      contraction exercises in the dorsal decubitus, sitting, and standing positions and was
      applied twice per week for a total of 15 sessions. The functional assessment of pelvic floor
      by vaginal digital palpation and perineometry was performed after 15 sessions of pelvic´s
      floor muscles training. The statistical analysis was performed using the Mann-Whitney and Z
      tests at a 5% level of significance.
    


Intervention name(s): Pelvic floor muscle therapy
Intervention type(s): Other
Intervention description(s): The women performed perineal contraction exercises in the dorsal decubitus, sitting, and standing positions and was applied twice per week for a total of 15 sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Pregnancy; Pelvic Floor; Muscle strength; Exercise therapy; natural childbirth; cesarean section; physiotherapy
Passive Heat Therapy and Age-associated Physiological Function
Condition: Aging
Study type: Interventional

Summary: 
      This study aims to determine the effects of 8-10 weeks of repeated hot water immersion ("heat
      therapy") vs. thermoneutral water immersion on vascular function in late middle-aged to older
      (55-79 years) adults.
    

Detailed description: 
      Advancing age is the primary risk factor for cardiovascular diseases (CVD), which remain the
      leading cause of death in the developed world. The key process that links aging to increased
      risk of CVD is the development of arterial dysfunction, including impaired endothelial
      function and arterial stiffening. In addition, age-associated impairments in arterial
      function have been linked to other diseases/disorders of aging, including cognitive
      impairments, Alzheimer's disease and dementia, and motor disorders/disability.

      Passive heat therapy, in the form of repeated use of hot baths and saunas, has been used by
      several cultures for centuries; however, the physiological benefits are only now being
      elucidated. For example, recent studies have found that lifelong habitual sauna use is
      associated with considerably reduced risk of all-cause mortality, sudden cardiac death,
      CVD-related death, and Alzheimer's disease and dementia. In addition, 8-10 weeks of hot water
      immersion in young adults has been shown to improve endothelial function and reduces arterial
      stiffness and blood pressure. Therefore, the investigators expect heat therapy to similarly
      improve vascular function, as well as cognitive and motor function, in middle-aged to older
      adults who are at greater risk of CVD and related diseases/disorders.
    

Intervention name(s): Heat therapy; Thermoneutral water immersion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 30 sessions (3-4x per week for 8-10 weeks) of hot water immersion in 40°C water, sufficient to raise body core temperature to 38.5°C.; 30 sessions (3-4x per week for 8-10 weeks) of hot water immersion in 36°C water to prevent changes in body core temperature >0.2°C.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled (parallel design), single-blind
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: endothelial function; arterial stiffness; heat; hot water immersion
Study Of Single And Ten Day Repeat Atopical Applications Of GW842470X Cream On The Skin Of Patients With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study of this study is to investigate the safety, tolerability and
      pharmacokinetics of GW842470X in patients with atopic dermatitis. GW842470X is an inhibitor
      of phosphodiesterase 4 (PDE4).
    


Intervention name(s): GW842470X; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GW842470X will be available as a yellow smooth water-in-oil cream.; GW842470X matching placebo will be available as a yellow smooth water-in-oil cream.
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: PK; GW842470X; safety; tolerability; PD; Atopic Dermatitis
A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether PF-06291874 is effective in the treatment
      T2DM
    

Detailed description: 
      This will be a randomized, double blind, stratified, placebo controlled, parallel group study
      conducted in T2DM subjects receiving background metformin therapy. Subjects will complete
      screening procedures to determine eligibility, followed by an 8 week metformin stabilization
      period prior to randomization. In addition, subjects taking other OADs, in combination with
      metformin, will undergo a washout during this period, in which non metformin OAD medications
      will be temporarily discontinued for the duration of the trial. Following confirmation of
      study eligibility criteria at randomization, subjects will be stratified into 2 groups based
      on the use of concomitant statin therapy. Each stratum will be randomized across treatment
      groups, such that the number of subjects taking concomitant statin therapy and those not
      taking statin therapy will be approximately balanced across treatment groups.
    

Intervention name(s): PF-06291874; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): study drug to be given as an oral tablet at 30, 60 or 100 mg; oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cross-over Study of the Efficacy and Safety of SierraSil Joint Formula 14 in Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      Osteoarthritis (OA) affects approximately 10% of people older than 60 years, and compromises
      the quality of life of more than 21 million North Americans. Studies on the use of
      complimentary and alternative medicines have reported that OA patients in the US are among
      the highest users of CAM. Previous studies on a unique natural mineral product SierraSil®
      demonstrated an improvement in joint health and function in subjects with mild to moderate OA
      of the knee. Extracts of Sierrasil® are reported to reduce cartilage degradation in response
      to IL-8 and nitric oxide production suggesting an ability to suppress IL-8 mediated events in
      human cartilage. The primary objective is to assess the efficacy of SeirraSil Joint Formula
      versus placebo on the symptoms of osteoarthritis as assessed by WOMAC™ Osteoarthritis Index
      Pain subscale in subjects with osteoarthritis of the knee.
    


Intervention name(s): SierraSil Joint Formula 14; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 667 mg SierraSil® hydrothermal mineral complex
Other intervention name(s): SierraSil® hydrothermal mineral complex
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Ostearthritis; Knee; SierraSil
A Pilot Bioequivalence Study Between Amphotericin B Liposome for Injection and AmBisome® in Healthy Subjects
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different
      amphotericin B liposome for injection after single IV infusion at the same dose in normal
      healthy subjects.
    


Intervention name(s): Amphotericin B liposome for injection; AmBisome®
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion; IV infusion
Other intervention name(s): the test product; the reference product
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Human Challenge Study to Evaluate the Efficacy of MV-012-968 Vaccine
Condition: RSV Infection
MeSH terms: Infections; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to evaluate whether the investigational, live
      attenuated, intranasally delivered vaccine MV-012-968 ('study vaccine') may have prophylactic
      efficacy against symptomatic RSV infection when administered to adults 18-45 years of age in
      the Human Viral Challenge model.
    


Intervention name(s): MV-012-968; Placebo
Intervention type(s): Biological; Other
Intervention description(s): MV-012-968 is a recombinant, live attenuated RSV vaccine.; Saline solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: RSV; vaccine; live attenuated; intranasal; challenge; Phase 2; safety; efficacy
The Effect of Thiazide, Amiloride and Hypertonic Saline on Urinary Biomarkers in Healthy Subjects
Condition: Nephropathy
MeSH terms: Kidney Diseases
Study type: Interventional

Summary: 
      Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) reflects the activity of the sodium-
      and water channels in the human kidney.

      Changes in the sodium-and water channel activity can be induced by blocking the sodium
      channels with diuretics in healthy subjects
    

Detailed description: 
      1. Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) reflects the kidneys transport of
           sodium and water in the nephron.

        2. Changes in the sodium-and water channel activity is induced by blocking the NCC channels
           with thiazide and ENaC channels with amiloride and by intervention with hypertonic NaCl
           The changes in sodium-and water channels are followed by changes in extracellular and
           intracellular fluids, central bloodpressure and the plasma concentration of vasoactive
           hormones.

      The purpose of this study is to investigate the changes in urinary biomarkers (u-NKCC2,
      u-ENaC-gamma and u-AQP2), extra- and intracellular fluid compartments, central bloodpressure
      and the plasma concentration of Vasoactive hormones in healthy subjects under a) treatment
      with Amiloride and Thiazide at baseline and b) after and acute infusion with hypertonic
      saline.

      Subjects will be examined on three examination days. Four days prior to the examination days
      the subjects will consume a standard diet based on amount of sodium and calories and
      randomized to treatment with either thiazide, amiloride or placebo twice daily for 5 days. On
      the examination days the subjects receive an infusion with hypertonic saline.

      Renal function is measured by renal clearance of 51Cr-EDTA. Urinary biomarkers (u-NKCC2,
      u-ENaC-gamma and u-AQP2) will be measured to evaluate the activity of water- and sodium
      channels in the nephron, changes in fluid compartments are measured by body composition
      monitor. Central blood pressure is measured by sphygmocor.
    

Intervention name(s): hypertonic saline
Intervention type(s): Other
Intervention description(s): hypertonic saline 3.0% 7 ml/kg
Other intervention name(s): NaCl 3.0 %
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: Nephrology; sodium-channels; water-channels; BCM; central blood pressure
A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Part A: The purpose of this study is to evaluate the safety and tolerability of single oral
      doses of E2006 administered in the morning to healthy male and female subjects.

      Part B: The purpose of this study is to evaluate selected pharmacodynamic (PD) parameters
      (e.g., polysomnographically defined sleep measures) with regard to dose response in subjects
      with primary insomnia following single oral dosing of E2006 in the evening approximately 30
      minutes prior to the sleep period, compared with 10 mg zolpidem and placebo.
    


Intervention name(s): E2006 1.0 mg; E2006 2.5 mg; E2006 5.0 mg; E2006 10.0 mg; E2006 25.0 mg; E2006 50.0 mg; E2006 100 mg; E2006 200 mg; Zolpidem 10 mg; E2006 Matched Placebo or Zolpidem Matched Placebo; E2006 Matched Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): E2006 1.0 mg capsule.; E2006 2.5 mg capsule.; E2006 5.0 mg (2 capsules of 2.5 mg each).; E2006 10.0 mg capsule.; E2006 25.0 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each).; E2006 50.0 mg capsule.; E2006 100 mg (2 capsules of 50 mg each).; E2006 200 mg (4 capsules of 50 mg each).; Zolpidem 10 mg immediate release tablet.; E2006-matched placebo capsules or zolpidem-matched placebo tablets.; E2006-matched placebo capsule.
Other intervention name(s): Lemborexant; Lemborexant; Lemborexant; Lemborexant; Lemborexant; Lemborexant; Lemborexant; Lemborexant
Intervention MeSH terms: Zolpidem; Lemborexant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Manipulation, Exercise, and Self-Care for Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The broad, long term objective of this interdisciplinary research is to identify effective
      therapies for low back pain sufferers and to increase our understanding of this important
      condition. The primary aim is to examine the relative efficacy of chiropractic spinal
      manipulation, rehabilitative exercise, and self-care education in terms of patient-rated
      outcomes in the short and long term for non-acute low back pain.
    

Detailed description: 
      Low back pain remains an important public health problem with serious socioeconomic
      consequences. Despite the considerable amount of research that has been preformed, there is
      still a dire need for randomized clinical tiles of high methodological quality. The broad,
      long-term objective of this interdisciplinary research is to identify effective therapies for
      low back pain sufferers and increased understanding of this important condition. Building
      upon the principal investigators' previous collaborative research, this randomized
      observer-blinded clinical trial will compare the following treatment for patients with
      nonacute low back pain:

        1. chiropractic spinal manipulation

        2. rehabilitative exercise

        3. self care education Theprimary aim is to examine the relative efficacy of the three
           interventions in terms of patient rated outcomes in the short-term (after 12 weeks) and
           the long-term (after 52 weeks) for nonacute low back pain.

      Secondary aims include:

        1. To examine the short and long-term relative cost effectiveness and cost utility of the
           three treatments.

        2. To assess if there are clinically important differences between pre-specified subgroups
           of low back pain patients. Subgroups are based on duration and current episode and
           radiating leg pain.

        3. To evaluate if there treatment group differences in objective lumbar spine function
           (range of motion, strength and endurance) after 12 weeks of treatment and if changes in
           lumbar function are associated with changes in patient rated short and long-term
           outcomes.

        4. To identify if baseline demographic or clinical variables can predict short or long-term
           outcome.

        5. To describe patients' interpretations and perceptions of outcome measures used in
           clinical trials.
    

Intervention name(s): Chiropractic Spinal Manipulation; Exercise; Self-care
Intervention type(s): Procedure; Procedure; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Chiropractic; Manual Therapy; Exercise; Randomized; Clinical Trial; Back Pain
Use of Chewing Gum to Facilitate Appetite Control and Weight Loss
Condition: Overweight; Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      This purpose of this study was to test the use of chewing gum as an adjunct to lifestyle
      modification to facilitate appetite control and weight loss in overweight and obese
      individuals.
    


Intervention name(s): Lifestyle modification; Lifestyle modification plus gum
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 16 weekly followed by 8 monthly group behavioral weight loss sessions.; 16 weekly followed by 8 monthly group behavioral weight loss sessions. Subjects were also given gum along with instructions for times and occasions to chew with the aim of facilitating weight loss and appetite control.
Other intervention name(s): Behavior modification; Behavioral weight loss; Behavior modification; Behavioral weight loss
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The present study is designed as a single-centre, randomized, controlled clinical trial to
      evaluate and compare the clinical and radiographic efficacy of two local drug delivery
      systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in
      patients with chronic periodontitis as an adjunct to SRP.
    

Detailed description: 
      Background: Rosuvastatin (RSV) and Atorvastatin (ATV) are known to inhibit osteoclastic bone
      resorption and were proposed to have osteostimulative properties by causing osteoblast
      differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of
      the present study is to evaluate and compare the efficacy of 1.2% RSV and 1.2% ATV gel as
      local drug delivery systems in adjunct to scaling and root planning (SRP) for the treatment
      of intrabony defects in patients with chronic periodontitis (CP).

      Methods: A total of 90 intrabony defects were treated with either 1.2% RSV, 1.2% ATV or
      placebo gel LDD after SRP. Clinical parameters (plaque index, modified sulcus bleeding index,
      probing depth and clinical attachment level) were recorded at baseline and 6 months.
      Radiographic intrabony defect depth change was calculated on standardized radiographs by
      using image analysis software at 6 months.
    

Intervention name(s): SRP with RSV gel LDD; SRP with ATV gel LDD; SRP with placebo gel LDD
Intervention type(s): Drug; Drug; Drug
Intervention description(s): After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket; After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket; After SRP, placebo gel was delivered subgingivally into the pocket
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Elacytarabine Mass Balance Study in Healthy Volunteers
Condition: Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is performed to measure the quantity of i.v. applied elacytarabine that leave the
      body, by which route and how fast.
    

Detailed description: 
      This is a single centre, open-label, non-randomised single dose study in healthy male
      subjects. Each subject will receive a single 15 min IV administration of 14C labelled
      elacytarabine.

      In this study, at least 6 subjects will be dosed in order to obtain data in 4 evaluable
      subjects.
    

Intervention name(s): [14C]-Elacytarabine
Intervention type(s): Drug
Intervention description(s): Single intravenous administration
Other intervention name(s): elacytarabine
Intervention MeSH terms: Cytarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Elacytarabine; pharmacokinetic; Microdose; Mass Balance Recovery
Way to Be Active I (Teams)
Condition: Sedentary Employees
Study type: Interventional

Summary: 
      Employers are increasingly looking for opportunities to motivate sedentary employees to
      become more physically active. Workplace walking programs have had mixed success and
      typically show most improvement among participants that are already fairly active at a
      baseline. The goal of this study is to determine whether a financial incentive program can
      motivate sedentary employees to increase the number of steps they walk per day to meet a
      minimum threshold.

      Our primary outcome measure is the proportion of days a minimum activity of 7000 steps or
      more is achieved. We will assess outcomes each week for 3 months using incentives followed by
      3 months of follow-up without incentives. Secondary outcomes will include the average steps
      walked per day.
    


Intervention name(s): Individual Incentives; Team Incentives; Individual plus Team Incentives
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Sedentary; Behavioral Economic Intervention; Team Studies; Financial Incentives; Workplace Wellness; Team Incentives