bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the
      treatment of the condition of stress urinary incontinence
    


Intervention name(s): Fesoterodine
Intervention type(s): Drug
Intervention description(s): Fesoterodine 4 mg and 8 mg and placebo - each dosed for 7 days with 7 day washout between dosing periods
Other intervention name(s): Toviaz
Intervention MeSH terms: Fesoterodine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Phase 2 stress urinary incontinence Fesoterodine
The Effects of Inhaled Aclidinium Bromide/Formoterol Fumarate on Inspiratory Pleural Pressures in Smokers
Condition: Smoking
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 3

Summary: 
      This short-term study aims to prove the potential cardio-protective physiological effect of
      inhaled aclidinium bromide/formoterol fumarate on inspiratory pleural pressures.

      Smoking is associated with gas-trapping (hyperinflation), even in the absence of chronic
      obstructive pulmonary disease. Breathing in the presence of gas-trapping requires large
      negative inspiratory pleural pressures, which are transmitted to the surface of the heart and
      increase cardiac wall stress.

      Inhaled aclidinium bromide and formoterol fumarate has been shown to reduce gas-trapping, but
      the impact on inspiratory pleural pressures and biomarkers of cardiac stress in smokers is
      unknown.
    


Intervention name(s): Aclidinium bromide/formoterol fumarate dihydrate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cross-over design with washout interval. Randomized order of active and placebo arm; Placebo and delivery device matched to active intervention
Other intervention name(s): DUAKLIR™ GENUAIR®
Intervention MeSH terms: Bromides; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pneumoproteins Expression in the Organ Donor
Condition: Primary Graft Dysfunction
MeSH terms: Primary Graft Dysfunction
Study type: Observational

Summary: 
      Primary graft dysfunction, a form of reperfusion pulmonary edema that occurs early after lung
      transplantation, shares key clinical and pathological features with acute lung injury and its
      more severe form, the acute respiratory distress syndrome. However, in contrast to acute lung
      injury/acute respiratory distress syndrome, in which biomarkers in plasma, urine and lung
      edema fluid have prognostic and pathogenetic value, the role of biomarkers in primary graft
      dysfunction has been less thoroughly explored. We will try in this study de determine the
      rule of pneumoproteins in the donor organ on the pulmonary edema in the recipient.
    


Intervention name(s): no intervention
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Organ donors and lung recipients
      
Biospecimen description: 
      lung tissues and serum
A Tailored Program to Promote Well-being and Physical Activity in Mid-life Adults With Low Physical Activity
Condition: Middle Aged; Exercise
Study type: Interventional

Summary: 
      This is a single-arm pilot trial to examine the feasibility, acceptability, and preliminary
      efficacy of the 12-week, phone-delivered, Midlife Activity, Stress reduction, Time
      Efficiency, Resilience, and Youthfulness (MASTERY) intervention, which utilizes positive
      psychology (PP), motivational interviewing (MI), and specific midlife modules (e.g., on time
      management, financial stress, caregiving stress, or occupational stress) to promote
      well-being and physical activity in mid-life adults.
    

Detailed description: 
      This is a single-arm proof-of-concept trial of a phone-delivered positive
      psychology-motivational interviewing (PP-MI) intervention, with content adapted to midlife
      persons. Midlife adults with low physical activity were recruited from outpatient clinics,
      completed baseline outcome measures (including wearing an accelerometer to measure activity
      for one week), completed the 12-week MASTERY intervention, and then completed a follow-up
      session to obtain repeat outcome information. The intervention, which involved weekly phone
      sessions with a trained study team member, included the completion of PP exercises, setting
      physical activity goals, and completion of activities to reduce midlife-specific stressors.
      The primary outcomes were feasibility and acceptability, and secondary outcomes included
      accelerometer-measured physical activity and self-report outcomes.
    

Intervention name(s): MASTERY
Intervention type(s): Behavioral
Intervention description(s): A 12-week, phone-delivered intervention utilizing positive psychology (PP), motivational interviewing (MI), and specific midlife modules (e.g., on time management, financial stress, caregiving stress, or occupational stress) to promote physical activity and well-being in mid-life adults.
Intervention model: Single Group Assignment
Intervention model description: All participants were in the same group and received the same intervention.
Masking: None (Open Label)
Primary purpose: Prevention
Research on the Effects of Combined Neurostimulation Protocols on Stress
Condition: Stress Reaction; Stress Related Disorder; Major Depressive Disorder
MeSH terms: Fractures, Stress; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The study examines the effects of the combined use of two different non-invasive brain
      stimulation (NIBS) techniques targeting the DLPFC on stress reactivity and recovery.
    

Detailed description: 
      Transcranial Direct Current Stimulation (tDCS) will be combined with intermittent Theta Burst
      Stimulation (iTBS) in order to maximize the effects coming from each of the techniques on
      their own. A group of 74 healthy participants wil be submitted to two different stimulation
      protocols (sham tDCS + active iTBS and active tDCS + active iTBS) with one-week in between
      and results on stress reactivity will be examined. In order to improve therapeutic protocols,
      this study with healthy participants is a crucial first step in order to further conduct
      clinical studies with psychiatric samples.
    

Intervention name(s): active tDCS; sham tDCS; iTBS
Intervention type(s): Device; Device; Device
Intervention description(s): A current of 2 milliampère (mA) through electrodes of 5x5cm.; Similar set-up as in the active tDCS, but stimulation is too short to cause any effects.; 54 cycles with 10 bursts of 3 pulses, train duration of 2 seconds and intertrain intervals of 6 seconds, results in 1620 pulses at 110% resting motor threshold.
Other intervention name(s): active/anodal transcranial direct current stimulation; sham transcranial direct current stimulation; intermittent theta burst stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Non-invasive Brain Stimulation; intermittent Theta Burst Stimulation (iTBS); Transcranial Direct Current Stimulation (tDCS); Dorsolateral Prefrontal Cortex; Stress reactivity; Stress-related Disorders; Major Depressive Disorder
Clinical Effects of Hard and Soft Tissue Grafting With Dental Implants
Condition: Dental Implants
Study type: Interventional

Summary: 
      The study will be done to see if Implant placement and simultaneous grafting using alloderm
      alone will result in the same facial ridge contour and soft tissue thickness as alloderm plus
      bovine derived xenograft. Is the facial soft tissue contour and thickness for alloderm plus
      bovine derived xenograft is significantly increased compared to alloderm alone.
    

Detailed description: 
      Thirty sequentially entered patients will have a dental implant placed in maxillary sites
      from 4 to 13. Any implant system is acceptable since the objective of the study is to
      evaluate soft tissue contour due to graft placement, not to evaluate the implant. Once
      selected for participation immediately prior to treatment, they are randomized for a
      treatment group by a coin toss. Fifteen patients will receive Alloderm alone (Positive
      Control Group) while another fifteen will receive Alloderm plus Bovine derived Xenograft
      (Test Group). The graft will be placed simultaneously with the dental implant. A blinded
      examiner Dr.Jodie Lusby will be used. Should the examiner become unblinded the subject will
      be excluded from the study. Means and standard deviations will be calculated for all
      parameters. A paired test will be used to evaluate the statistical significance of the
      differences between initial and final data. An unpaired t-test will be used to evaluate
      statistical differences between the test and control groups. A sample size of 12 will afford
      ≥ 80% statistical power to detect a difference of 0.4 mm soft tissue thickness between
      groups. P value will be set at p≤0.05.
    

Intervention name(s): Dental Implant &ADMG; Dental implant & ADMG & BDX
Intervention type(s): Device; Device
Intervention description(s): A dental implant will be placed and the buccal soft tissue will be grafted using ADMG .; Dental Implant will be placed with ADMG that covers the BDX
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups of 15 patients . One with soft tissue grafting and implant placement and other with soft and hard tissue grafting with implant placement.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alloderm; Dental Implants; Alveolar bone grafting
Hemodynamic Study of Avanafil and Two α-Adrenergic Blockers,Doxazosin and Tamsulosin
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if avanafil causes any changes in blood pressure and
      pulse rate when taken with doxazosin or tamsulosin.
    


Intervention name(s): Tamsulosin and avanafil; Doxazosin and avanafil
Intervention type(s): Drug; Drug
Intervention description(s): tamsulosin - 0.4mg daily for 18 days; avanafil - 200 mg 1 x 2 days; doxazosin - 1 mg 1 x 1 day; 2 mg 1 x 2 days; 4 mg 1 x 4 days; 8 mg 1 x 11 days; avanafil - 200 mg 1 x 1 day
Intervention MeSH terms: Doxazosin; Tamsulosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Twice-Daily Insulin Lispro Low Mixture Compared to a Once-Daily Long Acting Insulin Comparator in Patients Who Have Been Using One or More Oral Antihyperglycemic Agents Without Insulin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purposes of this study are to determine: 1. If patients taking insulin lispro LM with
      metformin will have better overall control of their blood sugar than patients taking a long
      acting insulin comparator with metformin. 2. If there is a difference in the way the two
      treatments affect blood sugar control before and after meals and at night. 3. If there is a
      difference in the insulin dose required with the two treatments. 4. If there is a difference
      in the numbers of times patients experience low blood sugar with the two treatments. 5. If
      there is a difference in the effect on patients's body weight.
    

Detailed description: 
      The aim of the present study is to compare two treatments - LM twice daily plus metformin two
      or three times daily versus a long acting insulin comparator once daily plus metformin two or
      three times daily - in patients with type 2 diabetes who are currently using a regimen of one
      or more oral antihyperglycemic agents.

      The primary objective of this study is to demonstrate that, in patients with type 2 diabetes
      who are new to insulin, hemoglobin A1c at endpoint will be lower after treatment with insulin
      lispro LM twice daily plus metformin than after treatment with a long acting insulin
      comparator once daily plus metformin.

      This will be a multicenter, randomized, open-label, crossover study comparing twice-daily
      insulin lispro LM plus two- or three-times-daily metformin to a once-daily long acting
      insulin comparator plus two- or three-times-daily metformin in patients with type 2 diabetes
      who were receiving one or more oral antihyperglycemic agents without insulin prior to the
      study.

      Following an 8 (+-2) week lead-in period consisting of treatment with NPH once daily at
      bedtime plus metformin two or three times daily, approximately 100 eligible patients will be
      randomized to one of two sequence groups, so that there are approximately 50 patients in each
      group. One group will receive 4 months of insulin lispro LM administered immediately before
      the morning and evening meals plus metformin two or three times daily followed by 4 months of
      a once-daily long acting insulin comparator at bedtime plus metformin two or three times
      daily. The other group will receive the reverse sequence.
    

Intervention name(s): Insulin Lispro low mixture
Intervention type(s): Drug
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus, insulin deficiency, hyperglycemia
Accute Effect of B-Turmactive Both on Mild and Moderate Knee Pain on Healthy Volunteers
Condition: Knee Injuries; Inflammation Knees
MeSH terms: Inflammation; Knee Injuries
Study type: Interventional

Summary: 
      The goal of this study is to assess the short (acutte) effect of B-Turmactive (one week
      treatment) both on mild/moderate knee pain
    

Detailed description: 
      Join pain is a common cause of consultation in primary health care in the adult population.
      Indeed, people who suffer knee pain, mostly due to osteoarthritis, require analgesic
      treatment, often with some secondary effects. Therefore, the research to find a natural and
      efficient product to reduce knee pain in a short period of time, facilitating recovery after
      exercise and without side effects have an interest both for industry and for the general
      population.

      B-turmactive is an extract of Curcuma longa mixing two fractions in a single product: a)
      soluble fraction free-curcuminoids but rich in polysaccharides and b) curcuminoids fraction
      with cyclodextrin. Both fractions plus vitamin C are B-turmactive.

      Previous preclinical studies suggest that B-turmactive could exert an acute effect in healthy
      people that suffer mild or moderate knee pain and, furthermore could reduce inflammation
      process.

      Therefore, the goal of this study is to assess the short (acute) effect of B-Turmactive (one
      week treatment) both on mild/moderate knee pain
    

Intervention name(s): B-turmactive; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The treatment consists of daily administration of B-TURMACTIVE®.
Treatment with B-TURMACTIVE® will last 7 days to determine the effects of the product in the short term, during which the volunteers will be visited 4 times:
V0 screening: to evaluate the inclusion and exclusion criteria. V1 inclusion and randomisation (Day 1): 1st day treatment and intervention. Measure primary and secondary variables V2 (Day 3): the primary endpoint will be monitored by telephone (perception of pain).
V3 (Day 7): Day 7 of treatment and final intervention. Measure primary and secondary variable; The treatment consists of daily administration of placebo capsule with identical format and harmless thant B-turmactive product.
Treatment with placebo will last 7 days to determine the effects of the product in the short term, during which the volunteers will be visited 4 times:
V0 screening: to evaluate the inclusion and exclusion criteria. V1 inclusion and randomisation (Day 1): 1st day treatment and intervention. Measure primary and secondary variables V2 (Day 3): the primary endpoint will be monitored by telephone (perception of pain).
V3 (Day 7): Day 7 of treatment and final intervention. Measure primary and secondary variable
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee-pain, curcuma, inflammation
To Investigate Pharmacokinetics (Absorption, Distribution, Elimination), Safety and Tolerability of a Single Oral Dose of 75 mg Molidustat Tablet in Male and Female Subjects Requiring Hemo- or Peritoneal Dialysis Compared to Healthy Subjects
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The study investigates the pharmacokinetics (absorption, distribution, elimination) of
      molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring
      hemo- or peritoneal dialysis compared to age-and gender-matched healthy subjects. In
      addition, the effect of molidustat on the hormone erythropoietin will be evaluated as well as
      the safety and tolerability of molidustat.
    


Intervention name(s): Molidustat(BAY85-3934); Molidustat(BAY85-3934)
Intervention type(s): Drug; Drug
Intervention description(s): Two single oral doses of 75 mg molidustat tablet in subjects on hemodialysis and peritoneal dialysis; One single oral dose of 75 mg molidustat in healthy subjects
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Chronic kidney disease; Pharmacokinetics; Hemodialysis; Peritoneal dialysis; Erythropoietin
The Effect of Pasteurized; Pasteurized and Homogenized and UHT Treated Homogenized Cow's Milk on Gastrointestinal Symptoms in Sensitive Adults
Condition: Unidentified Gastrointestinal Discomfort Following Dairy Consumption
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      This study aims to investigate differences in digestion rates and gastrointestinal problems
      caused by pasteurized; pasturized and homogenized as well as UHT-treated homogenized cow's
      milks in healthy adults by diary of symptoms, blood glucose and triacylglycerol levels and
      plasma cytokine levels.
    


Intervention name(s): Dietary intervention
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Single Doses of MK-0941 in Type 2 Diabetics (MK-0941-027)
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability of single doses of MK-0941 based on
      assessment of clinical and laboratory adverse experiences
    


Intervention name(s): MK-0941; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period; a single oral placebo will be administered in the designated period (Periods 1-5)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Motivations for Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This study tests the effects of emphasizing different motivations for wanting to lose weight
      on weight loss maintenance in women. At the start of the study, participants will be weighed
      and will complete questionnaires about their health, weight history, eating and exercise
      habits, body satisfaction and mood. Participants will then be randomly assigned to 1 of 4
      treatments. Participants in all 4 groups will receive information on topics related to eating
      and exercise, and will receive calorie and fat intake goals, and exercise goals. The 4
      treatments will differ in the emphasis given to various reasons for wanting to lose weight.
      At 6, 12 and 18 months after enrollment, participants will again have weights measured and
      fill out questionnaires.
    


Intervention name(s): Weight loss motivations
Intervention type(s): Behavioral
Intervention model: Factorial Assignment
Primary purpose: Treatment
Keywords: overweight
PRP Intrauterine Infusion in Thawed Embryo Cycles
Condition: Evaluations
Study type: Interventional
Phase: Phase 4

Summary: 
      All patients prepared to thawed embryo transfer were classified into 2 groups one group will
      receive platelet rich plasma (PRP) infusion intrauterine and the other group will not receive
      platelet rich plasma (PRP) infusion
    

Detailed description: 
      Patients candidates for Thawed embryo transfer with Repeated implantation failure were
      recruited from 3 centers and classified into 2 groups:

      Group I: Will receive platelet rich plasma (PRP) intrauterine infusion at day 11

      Group II: Not receiving platelet rich plasma (PRP)
    

Intervention name(s): Platelet rich plasma intrauterine infusion; Normal saline
Intervention type(s): Biological; Biological
Intervention description(s): platelet rich plasma will be prepared, activated then infused by Intrauterine insemination catheter intrauterine at day 11; Intrauterine infusion of normal saline at day 11
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups parallel
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Platelet rich plasma; Intrauterine infusion; Thawed embryos; IVF/ICSI cycles