bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Strength and Balance Training to Reduce the Fall Risk in Knee Osteoarthritis Patients
Condition: Sports Physical Therapy
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study will address the scarcity of research and the variations in recommendations
      regarding the effects of strength and balance training to reduce the fall risk in knee
      osteoarthritis patients.
    

Detailed description: 
      This Study will be conducted in Alkhidmat Raazi Hospital. Written informed consent for
      inclusion in the study was taken. Patients of experimental group will receive balance
      training with conventional along with TENS, heating pad for one hour 3 times weekly.
      Assessment will be performed pre and post of intervention. Intervention will be given 3 days
      a week for 8 weeks.
    

Intervention name(s): Experimental Group; Control Group
Intervention type(s): Other; Other
Intervention description(s): Assessment will be performed pre and post of intervention. Intervention will be given 3 days a week for 8 weeks. Each session will include a 5-min warm-up on a fitness bike or treadmill before commencement of the program and a 5-min cool period. Participants of this group will receive balance training with conventional treatment. Participants will perform between 2 sets of 5 and 7 repetitions of each exercise.
Single leg balance
Walking forward
Walking backward
Side stepping
Walk heel to toe
Static exercises with eyes close or open
CONVENTIONAL EXERCISE PROGRAM :
TENS for 15 minutes
Hot pack for 15 minutes
Participants will perform between 2 sets of 7 and 10 repetitions of each exercise:
Quadriceps/hamstring isometric exercises.
ROM and active stretching of the hamstring and quadriceps muscle.
Active ankle pump.
Squats,step-up, sit to stand, calf raises
Straigh leg raising exercise in crook lying position; Participants of this group will receive only conventional therapy which will include; before beginning the program, each session will feature a 5-minute warm-up on a fitness bike or treadmill, followed by a 5-minute cool-down. Participants of this group will receive only conventional therapy which will include.
CONVENTIONAL EXERCISE PROGRAM :
TENS for 15 minutes
Hot pack for 15 minutes
Participants will perform between 2 sets of 7 and 10 repetitions of each exercise:
Quadriceps/hamstring isometric exercises.
ROM and active stretching of the hamstring and quadriceps muscle.
Active ankle pump.
Squats,step-up, sit to stand, calf raises
Straigh leg raising exercise in crook lying position
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025%.
Condition: Hyperemia
MeSH terms: Hyperemia
Study type: Interventional
Phase: Phase 1

Summary: 
      To characterize the plasma pharmacokinetics and safety profile of brimonidine following a
      single dose and 4 times per day (QID) dosing of brimonidine tartrate ophthalmic solution
      0.025% for 7 days in healthy, adult subjects.
    


Intervention name(s): Brimonidine tartrate
Intervention type(s): Drug
Intervention MeSH terms: Brimonidine Tartrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Ocular Redness
Acute Vascular Response to Exercise in Women With Nonobstructive Coronary Artery Disease
Condition: Nonobstructive Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The purpose of this study is to examine the acute effect of exercise on vascular function in
      women with nonobstructive coronary artery disease.
    

Detailed description: 
      Women are more likely to have nonobstructive coronary artery disease (CAD) . The purpose of
      this study is to examine the acute effect of exercise on vascular function in women with
      nonobstructive coronary artery disease. Endothelium-dependent and -independent dilation,
      arterial stiffness and wave reflection will be measured at baseline and after walking on a
      treadmill at a slow pace for 47 minutes. Endothelium-dependent dilation will be measured
      using brachial artery flow-mediated dilation via high resolution ultrasonography.
      Endothelium-independent dilation will be measured using brachial artery dilation to
      sublingual nitroglycerin. Arterial stiffness and wave reflection will measured using
      applanation tonometry.
    

Intervention name(s): Slow-paced walking
Intervention type(s): Other
Intervention description(s): Subjects will walk on a treadmill at a slow pace for 47 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Analysis of Lymphocyte Cell Surface Adhesion Marker Expression in Natalizumab Population With Active Control
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The purpose of the study is to research the association between receiving Tysabri®
      (natalizumab), interferon beta-1a, glatiramer acetate or not having any treatment for your MS
      and how it may or may not impact certain white blood cells and other immunological markers.
      This information may be useful in identifying risk factors in developing progressive
      multifocal leukoencephalopathy (PML). It does appear that the risk increases with the total
      number of natalizumab infusions. Patients who have not yet started a disease modifying
      therapy or who have been on one other than natalizumab are needed as controls to see how
      these biomarkers change.

      Patients at various stages of natalizumab treatment as well as natalizumab naïve are needed
      to allow for analysis of the change in potential markers over time.
    

Detailed description: 
      Patients at various timepoints in their MS treatment or who are beginning certain MS
      treatments will be consented and have blood specimens collected to allow for an immunological
      comparison. The decision to treat with disease modifying therapies is made independently from
      this observational study.

      Primary endpoint: To further understand the delineation of lymphocyte cell adhesion marker
      down regulation within a treatment naïve patient population and at various stages of
      treatment.

      Secondary endpoint: To understand the correlation between natalizumab pharmacodynamics,
      pharmacokinetics and lymphocyte cell adhesion marker down regulation.

      The results of various biomarkers and immunological testing (including CD62L, LFA-1, sCD62L,
      sLFA-1, sVCAM, VLA-4 saturation, IgG4, CBC with absolute differential) will be compared
      amongst the groups consented. The treatment naive group will be compared longitudinally.
    

Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        Patients with Relapsing Remitting Multiple Sclerosis (RRMS) who are treated at Rocky
        Mountain Multiple Sclerosis Clinic, and who are currently undergoing disease modifying
        therapy, natalizumab, glatiramer acetate injections, interferon beta 1a, or who are
        beginning one of these disease modifying therapies.
      
Biospecimen description: 
      serum
    
Keywords: Immunological; biomarkers; observational; RRMS; Relapsing; Remitting Multiple Sclerosis
A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Dyslipidemia (MK-0859-051 AM1)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effects of anacetrapib (MK-0859) on low-density
      lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with
      dyslipidemia when added to an existing statin-modifying therapy.
    


Intervention name(s): Anacetrapib; Placebo for anacetrapib
Intervention type(s): Drug; Drug
Other intervention name(s): MK-0859
Intervention MeSH terms: Oxazolidinones; Anacetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ACT-541468 in Healthy Young Adults and Elderly Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK, or
      amount of drug over time in the body) and pharmacodynamics (PD, or effects on the body) of
      ACT-541468 following multiple ascending doses in healthy adults and following single
      ascending doses in healthy elderly subjects when administered in the morning. The safety, PK
      and PD of ACT-541468 will also be assessed after repeated evening administration of a
      selected dose in both healthy adults and elderly.
    

Detailed description: 
      In the first-in-man study, single doses of ACT-541468 administered in healthy young adults
      were well tolerated up to the dose level of 200 mg (inclusive) and yielded results compatible
      with possible sleep facilitating effects of ACT-541468. So the present study aimed to further
      investigate the effects of ACT-541468 after multiple ascending doses in healthy young
      subjects as well as after single ascending doses in elderly subjects (morning
      administrations). The effects of repeated administrations of a selected dose administered in
      the evening in both healthy adults and elderly, will also be investigated.
    

Intervention name(s): ACT-541468 (hydrochloride salt); ACT-541468 (free base); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Hard-gelatin capsules (strength: 5 mg and 25 mg); Soft capsules (strength: 25 mg); Placebo capsules matching the ACT-541468 formulations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: insomnia; Pharmacokinetics; Safety; Pharmacodynamics; Healthy
Erythropoietin and Platelet Activation Markers
Condition: Thrombosis; Hypertension
MeSH terms: Hypertension; Thrombosis
Study type: Interventional
Phase: Phase 4

Summary: 
      We hypothesized that the effect of erythropoietin may be reflected by changes in thromboxane
      B2 (TXB2) and endothelial cell function.

      Six male and six female subjects received recombinant human epoetin alpha (Erypo®)
      intravenously (300 Units per kg). Biomarker levels were assessed at baseline and 4, 24, 48
      and 72 hours after administration.
    

Detailed description: 
      Introduction: Erythropoietin (EPO) enhances formation of red blood cells and also affects
      thrombopoiesis and platelet function. We hypothesized that the effect of erythropoietin may
      be reflected by changes in thromboxane B2 (TXB2) and endothelial cell function.

      Methods: Six male and six female subjects received recombinant human epoetin alpha (Erypo®)
      intravenously (300 Units per kg). Biomarker levels were assessed at baseline and 4, 24, 48
      and 72 hours after administration.

      Results: Epoetin alpha increased TXB2 levels, which reached significance at 48h (2.5- fold
      increase: 6.6±5ng/mL vs. 15±9ng/mL; p=0.044) and remained at that level at 72h. In line,
      epoetin alpha increased E-selectin levels by 25% already at 24h (39±21ng/ml vs. 49±26ng/ml;
      p<0.001) and stayed at this level until 72h (p<0.001). The raise in platelet activation
      markers corresponded with a 2-fold increase in reticulocyte count (81±17G/L vs. 43±10G/L;
      p<0.001) and a 9% increase in platelet count at 72h (224±45G/L vs. 244±52G/L; p=0.005).
      Thrombomodulin and von Willebrand factor concentrations were not significantly altered by
      epoetin alpha. Interestingly, gender differences in the baseline levels of E-selectin and
      thrombomodulin were observed. E-selectin and thrombomodulin levels were doubled in men
      compared to women (51±24ng/mL and 28±10ng/mL; p=0.025 and 30±5ng/mL vs. 16±5ng/mL; p=0.002,
      respectively).

      Conclusion: Epoetin alpha increases levels of platelet activation markers. Further studies
      are needed to investigate whether measurement of TXB2 or E-selectin levels might be useful
      for estimation of thromboembolic risk during EPO-therapy.
    

Intervention name(s): erythropoietin
Intervention type(s): Drug
Intervention description(s): Subjects received one single intravenous injection of epoetin alpha (Erypo®, rhEPO, Ortho Biotech/Division of Janssen-Cilag Ag, Bridgewater, New Jersey, US) at a dose of 300 Units per kg bodyweight. Blood was sampled at baseline and 4, 24, 48 and 72 hours after administration of rhEPO during a biosimilarity trial.
Other intervention name(s): epo
Intervention MeSH terms: Epoetin Alfa
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: thrombosis; hypertension; gender; endothelium
A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived HIV-1 Recombinant Envelope Glycoprotein (gp160)
Condition: HIV Infections
MeSH terms: Vaccinia
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety of vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160)
      in human volunteers; to evaluate the immunogenicity of this preparation in human volunteers.
      Although recent advances have been made in antiviral therapy against AIDS, there is currently
      no cure for AIDS. It is likely that ultimate control of the disease depends on the
      development of safe and effective vaccines against HIV.
    

Detailed description: 
      Although recent advances have been made in antiviral therapy against AIDS, there is currently
      no cure for AIDS. It is likely that ultimate control of the disease depends on the
      development of safe and effective vaccines against HIV.

      Healthy, adult volunteers without identifiable high-risk behavior for HIV-1 infection are
      vaccinated. In phase 1, at each participating unit, four volunteers receive a dose of gp160
      (12.5 mcg); two volunteers receive placebo. Volunteers are monitored 1 month before
      proceeding to the second phase. In phase 2, four volunteers receive gp160 (50 mcg); two
      volunteers receive placebo. Primary immunization and two booster immunizations at day 30 and
      day 180 are done in an outpatient setting. Volunteers are closely monitored for the first 2
      weeks postimmunization (primary and boosters), and extensively followed for a minimum of 2
      years. Volunteers may be offered an additional boost of the same preparation at 18 months.
      Per 07/28/92 amendment, 18 volunteers will receive 200 mcg gp160 in an unblinded study.
      Volunteers in phase 2 who received four doses of 50 mcg gp160 receive an additional boost of
      200 mcg gp160 at 18-19 months post initial vaccination. Per 05/13/94 amendment, volunteers in
      phase 2 who received the additional 200 mcg boost receive another 200 mcg boost 18-24 months
      after the last injection (St. Louis University site only).
    

Intervention name(s): gp160 Vaccine (Immuno-AG)
Intervention type(s): Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Drug Evaluation; HIV Envelope Protein gp160; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
A Relative Bioavailability Study of SSP-004184AQ (Magnesium Salt) and SSP-004184SS (Disodium Salt)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the relative bioavailability of the new SSP-004184SS capsule
      formulation compared to the original SSP-004184AQ drug plus excipients formulation.
    


Intervention name(s): SSP-004184AQ; SSP-004184SS
Intervention type(s): Drug; Drug
Intervention description(s): Magnesium salt; Disodium salt
Other intervention name(s): SPD602; SPD602
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficiency of Repetitive Transcranial Magnetic Stimulation (rTMS) Sessions After a Successful 3 Week-treatment in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with
      fibromyalgia may maintain the clinical improvement.
    

Detailed description: 
      In a previous pilot study, a 3 week treatment with rTMS in fibromyalgia subjects induced a
      40% improvement of pain feeling. Three months later, the pain level was still significantly
      reduced in comparison with the beginning of the treatment, but the clinical improvement was
      less than at the end of the treatment. We thus propose to realize real or sham rTMS sessions
      at 3 weeks interval during 6 months with subjects presenting a significant clinical
      improvement after a 3 week-rTMS or sham treatment to evaluate the response maintenance.
    

Intervention name(s): rTMS; sham rTMS
Intervention type(s): Device; Device
Intervention description(s): one session : 20 runs of 10 seconds high frequency stimulation(10Hz) and 50 seconds pause - power equivalent to 90% of the motor threshold; same session as defined with the real rTMS, but with a coil not delivering magnetic field.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rTMS; fibromyalgia; sham; maintenance session; pain
Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration
Condition: Allergies
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluation of patch as specific immunotherapy in allergic patients
    


Intervention name(s): Purified allergen dose 1 integrated in a Patch system; Purified allergen dose 2 integrated in a Patch system; Purified allergen dose 3 integrated in a Patch system; Purified allergen integrated in a Patch system
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Epicutaneous application of a patch; Epicutaneous application of a patch; Epicutaneous application of a patch; Epicutaneous application of a patch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rhinoconjunctivitis; Allergic
Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI).
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      This study will evaluate the Indego® device for safety and effectiveness at allowing persons
      with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of
      conditions.
    


Intervention name(s): Indego
Intervention type(s): Device
Intervention description(s): Indego
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SCI; Indego; Walking
A Comparison of the Effects of Extended Release Tacrolimus (Advagraf®) vs. Immediate Release Tacrolimus (Prograf®) on Kidney Function in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the drug profiles (pharmacokinetics) and effects
      (pharmacodynamics) of Advagraf® and Prograf® on the kidneys.
    

Detailed description: 
      This is a 2 Period study. In Period 1, subjects will be assigned randomly to receive
      Advagraf® or Prograf® administered once or twice daily, respectively, for a period of 10
      days. In Period 2, subjects will be converted from Advagraf® to Prograf® or from Prograf® to
      Advagraf® for 10 additional days of dosing. Dose adjustments will be made based on the
      monitoring of drug levels in blood.
    

Intervention name(s): Advagraf®; Prograf®
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): tacrolimus XL, FK506E; tacrolimus, FK506
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: tacrolimus; Advagraf®; Prograf®; Glomerular Filtration Rate; Effective Renal Plasma Flow; Pharmacokinetics; Pharmacodynamics
Early Childhood Caries Prevention at a Pediatric Clinic
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This purpose of this study was to evaluate effectiveness of a risk-based dental caries
      prevention program conducted by dental personnel at an urban pediatric primary care clinic
      serving largely low-income residents of Baltimore, Maryland, and to appraise this program as
      a model for similar urban pediatric settings.
    

Detailed description: 
      A demonstration caries prevention trial lasting 26 months was conducted with a total of 219
      children aged 6 to 27 months of age. The "prevention" group consisting of children 6-15
      months of age at their initial visit were compared at the end of the trial with a
      "comparison" group at their initial visit. The comparison group was 12 months older than the
      enrollment age of the prevention group (18-27 months) and had not received previous routine
      professional dental care. Interventions were dental examination and periodic recalls,
      caries-risk assessments, monitoring of oral mutans streptococci (MS) levels, application of
      5.0% sodium fluoride varnish to teeth, dental health counseling to care-givers, referral for
      dental treatment if indicated and periodic recalls.

      Outcome measures were: 1) number of decayed, missing, filled primary tooth surfaces, 2)
      number of pre-carious lesions, 3) counts of oral MS and 3) care-giver responses to a
      questionnaire about the child's diet and home care.

      Prevention group children at the last recall experienced fewer mean carious dental surfaces
      (0.1 vs. 1.29, p<0.014) and over 8-fold less MS (p<0.013) than comparison group subjects at
      the initial visit. The number of precarious lesions, however, were not significantly
      different. In the absence of carious or precarious lesions, oral levels of MS was a reliable
      indicator of caries risk status, particularly for low risk subjects (sensitivity, 0.64;
      specificity, 0.98). Caregiver reports of dietary practices and presence or absence of visible
      dental plaque also served as caries-risk determinants.
    

Intervention name(s): fluoride varnish; patient education
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: dental caries; early childhood caries; caries prevention; infants