bioihbjkbjnl/mcl2 huggingface dataset:
Exercise Training and Cognitive Function in Kidney Disease
Condition: Cognitive Function, Preclinical; Chronic Kidney Diseases; Older Adults
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Chronic kidney disease (CKD), affects over 45% of all individuals over 70 years of age.
      Patients with moderate CKD have more than a two-fold increased risk of cognitive impairment
      than those without CKD; furthermore, as many as 20-70% of patients with CKD have established
      cognitive impairment and overt dementia. The burden of cognitive impairment and dementia
      leads to functional decline and accelerated loss of independence, contributing to the
      tremendous individual, societal, and economic burden of CKD (i.e., 20% of Medicare
      expenditures in adults >65 years of age). There is no recommended treatment to prevent
      cognitive decline in CKD patients, and the few medications available for cognitive impairment
      have only short term modest effects. There is a critical need to evaluate therapies to
      forestall cognitive impairment, and maintain or improve cognitive functioning in older
      patients with CKD. To address this need, this study will test the hypothesis that older
      patients with moderate/severe CKD and pre-clinical cognitive impairment randomized to a
      6-month home-based exercise program will improve cognitive function and MRI measured brain
      structure, compared to a usual care control group. This study will combine an assessment of
      cognition with MR imaging techniques to fully evaluate brain structure, blood flow, and
      behavior relationships at a level previously not conducted in this population
    


Intervention name(s): Partially supervised home-based walking exercise; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.; Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled design with a 1:1 allocation
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive function; Kidney Disease; Exercise; Older adults
A Healthy Subject Study With Z-360 and Placebo
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics
      (including food effect) of single and multiple doses of Z-360 in healthy Japanese subjects.
    

Detailed description: 
      This is a single centre, randomized, double-blind, placebo-controlled, parallel-group, and
      food effect study.This is three parts study. The purpose of the first part (Part 1) is the
      evaluation of the safety, tolerability, and pharmacokinetics after single ascending doses of
      Z-360.The second part (Part 2 ) is the evaluation of the pharmacokinetics of food effect of
      Z-360.The third part (Part 3) is the evaluation of the safety, tolerability, and
      pharmacokinetics after multiple ascending doses of Z-360.
    

Intervention name(s): Z-360; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Z-360; Japanese; pK
Levels of Raltegravir in the Female Genital Tissue
Condition: HIV
Study type: Interventional

Summary: 
      This study is an investigation of the pharmacokinetics of raltegravir in the tissue of the
      female genital tract to determine if twice-daily dosing of 400mg achieves adequate drug
      levels to prevent viral integration of HIV-1. The study will also assess whether drug levels
      change in the tissue across the different phases of the menstrual cycle.

        -  Hypothesis #1: Twice daily dosing with raltegravir 400mg will result in intracellular
           concentrations that should be sufficient to suppress HIV-1 replication throughout the
           menstrual cycle.

        -  Hypothesis #2: Intracellular genital raltegravir peaks will be lower and troughs higher
           compared to extracellular concentrations in the plasma and PMBCs (peripheral blood
           mononuclear cells).

        -  Hypothesis #3: Intracellular raltegravir concentrations will be slightly lower during
           the luteal phase of the menstrual cycle due to cellular pumps such as p-glycoprotein,
           which are present in higher numbers during periods of high progesterone.
    

Detailed description: 
      HIV-1 is shed in genital secretions which increase the risk of transmission between sexual
      partners and from mother to infant. Antiretroviral medication taken prior to exposure to
      HIV-1 can prevent viral transmission from a mother to her infant. Raltegravir (RAL), by
      blocking integration of viral cDNA into the host's genome, makes an excellent candidate for
      preventing HIV-1 infection. RAL is licensed for treatment with twice-daily dosing based on
      plasma trough concentrations; however, intracellular concentrations of RAL which are relevant
      to blocking infection of cells have not been previously studied. P-glycoprotein pumps, which
      are involved in regulating drug absorption and metabolism, can influence intracellular drug
      concentrations. P-glycoprotein concentrations appear to vary with menstrual cycle suggesting
      it may affect intracellular drug concentration of RAL in women.

      Women will be enrolled in the study and followed during the course of a menstrual cycle while
      taking a dose of 400mg PO twice daily. An initial screening visit will be performed prior to
      enrollment and participation in the study. Review of medical history as well as blood and
      urine collection will occur during the screening visit. Once enrolled, participants will have
      blood and genital tract samples collected once a week for four weeks to assess intracellular
      concentrations of RAL in the blood and genital tract tissue.
    

Intervention name(s): Raltegravir
Intervention type(s): Drug
Intervention description(s): Dosage: 400mg/PO (by mouth) Frequency: Twice daily Duration: During course of menstrual cycle (28 days)
Other intervention name(s): Isentress
Intervention MeSH terms: Raltegravir Potassium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Raltegravir; Pharmacokinetics
Prevention of Umbilical Port-site Hernia After Laparoscopic Cholecystectomy Using a Prosthetic Mesh Versus Simple Suture
Condition: Port-site Hernia
MeSH terms: Hernia
Study type: Interventional
Phase: Phase 3

Summary: 
      The incidence of port-site hernia in patients with risk factors (obesity, elderly, diabetes
      and lung disorders) can be reduced by the use of a prophylactic mesh in the closure of
      umbilical port site.
    


Intervention name(s): Prophylactic mesh placement; Fascial suture
Intervention type(s): Procedure; Procedure
Intervention description(s): Placement of a Omega 3 mesh, fixed to the border of the fascia; The port-site hole is closed with simple suture of the fascia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.
Condition: Sensation Disorder
MeSH terms: Sensation Disorders
Study type: Observational

Summary: 
      Our research has shown that pressure sensation from the soles of the feet (plantar
      mechanoreceptors) plays an important role in controlling several key aspects of balancing
      reactions, particularly during compensatory stepping . As a result, age-related loss of
      plantar pressure sensation, which is very common, can lead to impaired control of these
      reactions. However, we have shown that it is possible to compensate for balance impairments
      resulting from this loss of sensation by using special footwear insoles to facilitate
      sensation from the perimeter of the sole. To date, we have demonstrated the feasibility of
      this approach in laboratory studies, and we have obtained a U.S. patent for the design
      concept. However, it remains to be determined whether the benefits of the footwear persist
      over the long term, or whether there is a habituation of the effect. Also, we need to
      determine whether there are any practical problems associated with wearing such footwear,
      e.g. due to discomfort or irritation of the skin.
    


Intervention name(s): SoleSensor
Intervention type(s): Device
Observational model: Defined Population
Time perspective: Prospective
Effects of n-3 Polyunsaturated Fatty Acids and Antioxidants on Postprandial Hyperlipidemia and Vascular Function in Men
Condition: Cardiovascular Diseases; Vasodilation
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Diet has long been used as a way to provide enough nutrients to an individual in order to
      meet metabolic requirements. However, recent scientific advancements have suggested that
      beyond meeting nutrition needs, diet may also be health promoting through the modulation of
      various body functions. In a way, the role of nutrition has evolved from hunger satisfaction
      and maintenance of body integrity to the promotion of a state of well-being and prevention of
      important chronic diseases such as cancer, diabetes and cardiovascular disease (CVD). In
      recent years, n-3 polyunsaturated fatty acids (PUFA) have attracted much attention as
      consumption of a n-3 PUFA rich diet has been reported to reduce CVD risk. However, n-3 PUFA
      are also highly susceptible to free radical damage and therefore could be unable to fully
      exert their health benefits under an oxidative stress condition. The general objective of the
      present application is to investigate the mechanisms by which n-3 PUFA improve cardiovascular
      health in abdominal obesity and explore the potential of dietary antioxidants to modulate
      these effects in individuals at high risk of oxidative stress. For that purpose, we plan to
      study the changes in fasting and postprandial plasma lipoprotein-lipid levels, markers of
      lipid and lipoprotein oxidation, inflammation and endothelial dysfunction following 12 weeks
      of n-3 PUFA supplementation with or without low-calorie cranberry juice cocktail (as a source
      of antioxidants) in a group of 160 men. We feel that the present study will broaden our
      understanding of the physiological mechanisms underlying the beneficial effects of consuming
      unsaturated fatty acids and give further insights on the role of antioxidants in preserving
      and potentiating these cardiovascular health benefits.
    


Intervention name(s): Nutrition
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cardioprotective Benefits of Carvedilol-CR or Valsartan Added to Lisinopril
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      14-week single blind, double baseline, forced-titration, cross-over comparison of the cardiac
      benefits of Coreg CR compared to valsartan added to existing ACE inhibition
    

Detailed description: 
      Combination drug therapy is necessary for optimal blood pressure reduction and current
      guidelines mandate the concomitant use of ACE inhibitors and β-blockers in most patients at
      significant risk for cardiovascular disease (CVD) events. There is also continuing interest
      in combining angiotensin receptor blockers (ARBs) with ACE inhibitors in hypertension based
      on the unsubstantiated belief that "more complete" renin-angiotensin system inhibition is
      desirable. It is more attractive physiologically to combine a long-acting β-blocker with
      vasodilatory actions (carvedilol CR) with an ACE inhibitor because this combination addresses
      more directly the two fundamental hemodynamic changes needed to reduce CVD events: lowering
      systolic BP (afterload) and lowering heart rate; the product of the two is a reliable
      surrogate for reduced cardiac work. In fact, clinical trial data suggest that there is no
      appreciable additional BP lowering when ARBs are added to ACE inhibitors and neither class
      lowers heart rate. The present proposal is designed to demonstrate the superior
      "cardioprotection" of carvedilol CR compared to ARB (valsartan) when each is added to
      background ACE inhibitor therapy. Principal dependent variables include ambulatory cardiac
      work (24-hour mean ambulatory systolic BP x heart rate) and laboratory stress responses
      (central systolic time-tension indices derived from arterial tonometry pre- and post-bicycle
      exercise). Secondary hemodynamic variables will define changes in flow and pressure (e.g.
      central systolic BP and forward and reflected pressure wave estimations).
    

Intervention name(s): Carvedilol CR; Valsartan
Intervention type(s): Drug; Drug
Other intervention name(s): Coreg CR; Diovan
Intervention MeSH terms: Valsartan; Carvedilol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Run-in period with lisinopril is followed by random entry into valsartan followed by carvedilol CR or carvedilol CR followed by valsartan
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cardiac work; carvedilol CR; valsartan; tonometry
Psychophysiological Effects of Probiotic Supplementation
Condition: Mild to Moderate Levels of Stress
Study type: Interventional

Summary: 
      This is a pilot exploratory study to investigate the effects of a probiotic Bifidobacterium
      longum NCC3001 intake on physiological and psychophysiological parameters related to stress
      in healthy individuals with mild to moderate stress level.
    

Detailed description: 
      The purpose of the study is to explore the effects of a probiotic Bifidobacterium longum
      NCC3001 intake on physiological and psychophysiological parameters related to stress in
      healthy individuals with mild to moderate stress level.

      The objectives is three:

        -  Measure the effects of a 6-week supplementation with NCC3001 on psychological and
           physiological parameters in response to an acute experimental stress;

        -  Measure the effects of a 6-week supplementation with NCC3001 on chronic stress level,
           gastro-intestinal symptoms and sleep quality;

        -  Explore changes in the profiles of biological parameters associated with ingestion of
           NCC3001; including changes in hormones, neurotransmitters, circulating immune and
           microbiome-derived molecules and changes in the microbiome itself
    

Intervention name(s): Experimental probiotic product; Placebo comparator
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Probiotic supplementation; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Exploratory, randomized, placebo-controlled, 2-arms, double-blinded, parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Clomiphene Plus N-acetyl Cysteine for Induction of Ovulation in Newly Diagnosed Pcos.
Condition: PCOS
Study type: Interventional
Phase: Phase 4

Summary: 
      Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders, affecting
      approximately 6-10% of women of reproductive age. Anovulation, infertility and
      hyperandrogenism often co-exist with hyperinsulinaemia and insulin resistance .

      Clomiphene citrate remains the standard drug for induction or augmentation of ovulation.
      However, it is not equally effective in all situations, and therefore it may require
      additional expensive drugs such as N-acetyl cysteine, as an antioxidant, has been suggested
      as an adjuvant in clomiphene-resistant cases .NAC may also improve the circulating level of
      insulin and insulin sensitivity in hyperinsulinaemic women with PCOS, and may be useful for
      the treatment of insulin resistance by ameliorating the homocysteine and lipid profile in
      PCOS .
    

Detailed description: 
      NAC has been used effectively as an adjuvant to clomiphene citrate (CC) for ovulation
      induction in CC-resistant women with PCOS .

      Because it is an insulin sensitizer, NAC was proposed as an adjuvant to clomiphene citrate
      for ovulation induction in patients with polycystic ovary syndrome who are resistant to
      clomiphene citrate. Encouraging results in those patients stimulated us to investigate
      whether adding NAC to the standard treatment with CC results in a higher ovulation rate,
      higher pregnancy rate, and less CC resistance in women with newly diagnosed polycystic ovary
      syndrome using a randomized, double-blind, controlled study.
    

Intervention name(s): NAC
Intervention type(s): Drug
Intervention description(s): NAC 2gm plus cc 100mg from 3rd day of the cycle till day 8 with u/s follow up of the follicular growth.
Other intervention name(s): N-acetyl cystien
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: PCOS,; NAC,; OVULATION INDUCTION,; CLOMOPHEN CITRATE
Treatment of Fibromyalgia Using Deep Shaped-Field Transcranial Magnetic Stimulation a Clinical Feasibility Study
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Deep shaped-field transcranial magnetic stimulation is a new type of transcranial magnetic
      stimulation technology which may provide a drug-free method for treating fibromyalgia.

      The purpose of this study is to determine the effectiveness and the durability of effect of
      Deep shaped-field repetitive transcranial magnetic stimulation (rTMS) in men and women
      diagnosed with fibromyalgia.
    


Intervention name(s): DSF-rTMS
Intervention type(s): Device
Intervention description(s): Effective Transcranial Magnetic Stimulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibromyalgia; Transcranial Magnetic Stimulation; Pain
Evaluation of the Effect of an Ankle Foot Orthoses for Ambulatory Function
Condition: Hemiplegia, Spastic
MeSH terms: Hemiplegia
Study type: Observational

Summary: 
      The main purpose of this investigation is to evaluate the effect of a lower leg brace on
      walking efficiency and community walking in people who have weakness in one side of the body
      caused after a stroke. The evaluation will consist of several tests that will evaluate
      movement, tightness, balance and sensation in affected leg.
    

Detailed description: 
      To comprehensively evaluate the effect of an AFO on ambulatory function and loading in
      hemiplegic gait. This study is addressing important questions regarding the effect of an AFO
      on gait and introduces technology for quantifiable objective assessment of AFO effectiveness.
      It will attempt to identify if AFO wear compliance increases community ambulation and walking
      efficiency bilaterally. Research is needed to fully understand how compliance affects
      mobility outcomes.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with a history of hemiplegia secondary to stroke, between the ages of 18 and
        75, who are greater than 6 months post and have been prescribed a custom molded AFO for
        assistance with gait deviations
      
Keywords: Stroke; Hemiplegia; AFO; Gait
Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201
Condition: Ulcerative Colitis; Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single centre, Phase 1, Placebo-controlled, Randomized, Doubleblind, SAD & MAD
      Study to Assess the Safety, Tolerability and PK of HM201 in Healthy Subjects.
    

Detailed description: 
      Objective of the study is to assess the safety, tolerability, and PK of single and multiple
      intravenous administration of HM201. The study design consists of a SAD study of 4 cohorts, 8
      subjects each cohort and a different dose level per cohort. In each cohort 2 will receive the
      placebo while rest of group will be administered with HM201. A total of 32 subjects are
      planned for the SAD study.

      MAD part will begin after cohort 1 and 2 of SAD is completed. MAD will consist of 8 subjects;
      2 will receive the placebo while 6 will be administered with HM201. MAD will be conducted in
      a dose escalation manner with 4 weekly doses administered to all subjects. One randomization
      scheme will be produced for each cohort separately.
    

Intervention name(s): HM201; Placebo; HM201; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): HM201 will be administered intravenously.; Placebo will be administered intravenously.; HM201 will be administered intravenously.; Placebo will be administered intravenously.
Other intervention name(s): Pegylated human adrenomedullin; Matching Placebo; Pegylated human adrenomedullin; Matching Placebo
Intervention MeSH terms: Adrenomedullin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SAD & MAD study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment