bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of the Effects of Cycling FES and Conservative Rehabilitation Therapy on Stroke Patients
Condition: Hemiplegia
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      Comparison of the effects of cycling functional electrical stimulation and conservative
      rehabilitation therapy on the functional status and muscle characteristics of stroke patients
    

Detailed description: 
      Stroke is the second leading cause of death worldwide and is a major contributor to
      disability. It is one of the developments related to bleeding as a result of occlusion of
      blood vessels in the brain with a clot or damage from the vessels.Loss of strength and motor
      coordination in the lower and upper extremities is the main cause of disability after stroke.
      Activities such as walking, standing, sitting and daily activities such as dressing, bathing
      and toilet are frequently affected and sensorimotor disorders are common.

      Functional electrical stimulation (FES) is one of the methods used in treatment. FES provides
      muscle contraction and movement by electrical stimulation of motor neurons. It is applied by
      a controller through skin electrodes to induce contractions. The FES-evoked bike allows
      people with or without voluntary leg movement to pedal an exercise bike on a fixed system.

      In this study, the investigators aimed to compare the treatment efficacy and changes in
      muscle characteristics of conservative treatment and cycling FES in stroke patients.

      Demographic data of the patients and healthy volunteers will be recorded. Hemiplegic patients
      will be evaluated in terms of Barthel Index, Modified Ashworth Scale, Berg Balance Scale,
      Functional Ambulation Scale, Brunnstrom's Hemiplegia Recovery Stage, Fatigue Severity Scale,
      Fugl-Meyer Assessment, 6-Minute Walking Test, Muscle strength measurement, pennation angle
      and thickness measurement of the musculus rectus femoris muscle
    

Intervention name(s): Conservative rehabilitation; Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation
Intervention type(s): Other; Other
Intervention description(s): Joint range of motion, strengthening, balance-coordination and stretching exercises included in the conservative physiotherapy program 5 days a week for a total of 6 weeks; In addition to conservative treatment, cycling FES to the affected lower extremity for 20 minutes, 3 days a week for 4 weeks. During the treatment, the patient will be seated on a chair and her feet will be fixed to the pedal with velcro tape, and the comfort during the treatment will be provided with calf supports.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05%
      lotions in asymptomatic subjects.
    

Detailed description: 
      Study Type: Interventional Study Design: An open label, one period, randomized,
      vasoconstrictor assay study.

      Official Title: Bioequivalence of two Clobetasol Propionate 0.05% Topical Lotions

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      · Vasoconstrictor Response
    

Intervention name(s): Clobetasol Propionate 0.05% lotion, single exposure; Clobex TM 0.05% Lotion, single exposure
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Alpharma USPD, Inc formulated products; B:Active Comparator Subjects received Galderma Laboratories, L.P. formulated products
Other intervention name(s): Clobetasol; Clobetasol
Intervention MeSH terms: Clobetasol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bio-Equivalence; Vasoconstriction; Clobetasol; Healthy adult females
Open Eye Corneal Swelling With Daily Disposable Contact Lenses and no Lens Wear
Condition: Corneal Swelling
Study type: Interventional

Summary: 
      The primary purpose of this clinical trial is to evaluate the eye's response to three test
      soft contact lenses as well as no lens wear, with respect to Corneal Staining.
    


Intervention name(s): etafilcon A with Lacreon; etafilcon A with Lacreon with print; etafilcon A with print; Spectacles (habitual)
Intervention type(s): Device; Device; Device; Device
Intervention description(s): contact lens with Lacreon; contact lens with Lacreon and cosmetic print; contact lens with print; Spectacles
Other intervention name(s): Test 1; Test 2; Test 3
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Different Irrigation Activation Techniques on Postoperative Pain After Endodontic Treatment
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of different irrigation activation methods on
      postoperative pain using visual analog scale (VAS) using Xp-endo Finisher, EndoActivator and
      Passive ultrasonic irrigation activation techniques with traditional irrigation method.

      In this study, Traditional Irrigation (GI), Xp-endo Finisher (XPF), Passive Ultrasonic
      Irrigation (PUI), EndoActivator (EA) techniques will be used for irrigation activation.
      Twenty-five maxillary or mandibular single root and canal-shaped nonvital teeth will used in
      each group. Root canals will be prepared with TF-Adaptive system. Four different activation
      techniques will be applied during final irrigation. The canal treatments will be completed in
      one stage and postoperative pain analysis will be taken with VAS (Visual Analog Scale) scale
      after 12-24-48 hours. Statistical analysis will be performed with Mann Whitney-U test.
    

Detailed description: 
      Vaious irrigation activation techniques have been used endodontic practice. These techniques
      are used to improve the activity of solutions. The selected techniques in this study are
      accepted as efficient methods for activation. However, postoperative pan is an important
      issue for clinicians. Thus, Traditional Irrigation (GI), Xp-endo Finisher (XPF), Passive
      Ultrasonic Irrigation (PUI), EndoActivator (EA) techniques will be used for irrigation
      activation. All techniques remove hard and soft tissue remnants successfully. The clinician
      expect to eliminate the postoperative pain. Therefore, a possible increase in pain due to
      activation technique may limit the use of these methods. The pain scores will be measured
      using the scale and statistically analyzed.
    

Intervention name(s): Traditional Irrigation; Xp-endo Finisher (XPF); Passive Ultrasonic Irrigation; EndoActivator
Intervention type(s): Procedure; Device; Device; Device
Intervention description(s): irrigation with syringe; irrigation activation file; irrigation activation method; irrigation activation method
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I Study in Healthy Volunteers to Assess Safety of BMS747158
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical research study is to learn the safety and biodistribution of
      BMS747158 in normal, healthy volunteers.
    


Intervention name(s): BMS747158
Intervention type(s): Drug
Intervention description(s): Single dose administration.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study to Assess the Safety, Tolerability and Anti-tumour Activity of Ascending Doses of Selumetinib in Combination With MEDI4736 and Selumetinib in Combination With MEDI4736 and Tremelimumab in Patients With Advanced Solid Tumours
Condition: Lung Cancer; Melanoma; Head and Neck Carcinoma; Gastroesophageal Cancer; Breast Cancer; Pancreatic Adenocarcinoma; Colorectal Cancer; Biliary Tract Cancer
MeSH terms: Biliary Tract Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, multi-centre, drug combination study of double and triple
      combination oral selumetinib (AZD6244 Hyd-sulfate) plus intravenous (IV) MEDI4736 and oral
      selumetinib plus IV MEDI4736 and IV tremelimumab in patients with advanced solid tumours.
    

Detailed description: 
      This is a Phase I, open-label, multi-centre, drug combination study of double and triple
      combination oral selumetinib (AZD6244 Hyd-sulfate) plus intravenous (IV) MEDI4736 and oral
      selumetinib plus IV MEDI4736 and IV tremelimumab in patients with advanced solid tumours
      refractory to standard therapy or for which no standard therapy exists. The safety,
      tolerability, and preliminary anti-tumour activity of ascending doses of Selumetinib (AZD6244
      Hyd-sulfate) in Combination with MEDI4736 and Selumetinib in Combination with MEDI4736 and
      Tremelimumab will be investigated. Once safety and tolerability have been established for the
      relevant dose, expansion cohorts will commence in order to further evaluate safety,
      tolerability, and provide a preliminary evaluation of the mechanism of action and anti-tumour
      activity of the drug combination. Mandatory paired biopsy expansion cohorts will be
      tumour-type specific. Expansion cohorts will open independently for double and triple
      combination treatments.
    

Intervention name(s): Selumetinib; MEDI4736; Tremelimumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Selumetinib oral; MEDI4736 IV; Tremelimumab, IV
Intervention MeSH terms: Durvalumab; Tremelimumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Selumetinib; Tremelimumab; MEDI4736; Safety; Tolerability; Pharmacokinetics; Patients with advanced solid tumours; Disease progression
Single-Dose, Crossover Study To Compare Bioavailability Of Two Formulations Under Fed And Fasted Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To Compare The Bioavailability Of 40 Mg Doses Of Pf-00345439 Modified Formulation K Vs.
      Original Formulation X Under Fed And Fasting Conditions In Healthy Volunteers
    


Intervention name(s): Oxycodone; Oxycodone; Oxycodone; Oxycodone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One capsule of 40 mg PF-00345439 Formulation X, single dose, under fed conditions; One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions; One capsule of 40 mg PF-00345439 Formulation X, single dose, under fasting conditions; One capsule of 40 mg PF-00345439 Formulation K, single dose, under fasting conditions
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; bioequivalence; bioavailability; oxycodone
A Comparison of Activities of Daily Living, Physical Fitness and Quality of Life in Obese and Healthy Adolescents
Condition: Obesity, Childhood; Healthy
MeSH terms: Pediatric Obesity
Study type: Observational [Patient Registry]

Summary: 
      It is known that activities of daily living, physical fitness, exercise capacity and quality
      of life are affected by the obesity. It is aimed to determine the effects obesity on daily
      living activities, physical fitness, exercise capacity and quality of life in obese
      adolescents compared to healthy subjects in this study. The relationship between these
      parameters and the activities of daily living which are less studied in obese adolescents
      will be evaluated.
    

Detailed description: 
      Obesity among children, adolescents and adults has emerged as one of the most serious public
      health problems in the 21st century. There has been a significant decrease in the exercise
      capacity, physical fitness and activities of daily living of children and adolescents with
      the increase in the prevalence of obesity over the last decade. Obesity can cause not only
      health problems but also psychological effects. This situation have negative effects on the
      quality of life. The effect of these parameters on healthy individuals and obese adolescents
      will be demonstrated by this study and will guide the rehabilitation of obese adolescents.
    

Intervention name(s): Exercise Capacity
Intervention type(s): Diagnostic Test
Intervention description(s): Modified Shuttle Walk Test
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        15 obese adolescents, 15 obese adolescent adolescents and 15 healthy female adolescents and
        15 healthy male adolescents compatible with age and sex will be recruited from obese
        adolescents according to the BMI reference system.
      
Keywords: Physical Fitness; Exercise Capacity; Activities of Daily Living; Quality of Life
The Protein (Meat) and Function Study
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the proposed study is to investigate the effects of different amounts of protein
      intake primarily from meat on muscle function, immune response, mental function, proteomics,
      biochemical regulators of protein metabolism, energy expenditure, and composition in young
      healthy males.
    


Intervention name(s): Placebo; Protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Placebo; 30 E% from protein
Intervention model: Parallel Assignment
Primary purpose: Basic Science
Keywords: Protein Function; normal versus high protein intake
Phase Ⅰa Clinical Trial of a Pneumococcal Vaccine
Condition: Pneumonia; Respiratory Tract Diseases; Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections; Respiratory Tract Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Infections with Streptococcus pneumoniae often cause serious health problems, especially for
      infants and the elderly.Failure to cover all polysaccharide types is an even greater problem
      with adults than with children.

      The aim of the study is to preliminary evaluate the safety and immunogenicity of PBPV vaccine
      compared to placebo,in order to provide a basis for subsequent clinical trial design.
    

Detailed description: 
      The polysaccharide vaccine protected 60% of elderly adults who were at risk for pneumococcal
      infection.However, pneumococci are highly diverse with respect to their capsular types , and
      the polysaccharide-protein conjugate vaccines will not protect against strains of the many
      capsular types not included in the vaccine.This experimental vaccine was covered 70% of all
      pneumococcal types, Subjects will receive three doses of PBPV vaccine on day 0,60 and 120
      with different contents of 20μg,50μg,100μg each antigen in 18 to 49 years of age.
    

Intervention name(s): Protein based pneumococcal vaccine(Low dose); Protein based pneumococcal vaccine placebo(Low dose); Protein based pneumococcal vaccine(Middle dose); Protein based pneumococcal vaccine placebo(Middle dose); Protein based pneumococcal vaccine(High dose); Protein based pneumococcal vaccine placebo(High dose)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.2mL,Intramuscular other name:PBPV; 0.2mL,Intramuscular other name:PBPV placebo; 0.5mL,Intramuscular other name:PBPV; 0.5mL,Intramuscular other name:PBPV placebo; 1.0mL,Intramuscular other name:PBPV; 1.0mL,Intramuscular other name:PBPV placebo
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccnie; PspA; Pneomolysin
Crossover Study to Assess the Efficacy of PT003 With and Without a Valved Holding Chamber in Subjects With Moderate to Severe COPD
Condition: COPD
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days),
      Multi-center, Crossover Study to Assess the Efficacy of PT003 in Subjects with Moderate to
      Severe COPD with and without a Valved Holding Chamber.
    


Intervention name(s): GFF MDI (PT003) with Aerochamber; GFF MDI (PT003) without Aerochamber
Intervention type(s): Device; Device
Intervention description(s): Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) with Aerochamber Plus Valved Holding Chamber; Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) without Aerochamber Plus Valved Holding Chamber
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Wellbutrin XL Effects on SSRIs Induced Changes
Condition: Depression; Side Effects; Sexual Dysfunction; Apathy
MeSH terms: Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find out differences in activation of mood regulating areas
      of the brain in response to negative and positive pictures, before and after 6 weeks of
      additional Wellbutrin XL treatment. Participants should have been treated for depression with
      an SSRI medication (e.g., Prozac, Zoloft, Paxil, Celexa or Lexapro) and have decreased
      depression symptoms but also be experiencing side effects of medications such as sexual side
      effects and feelings of apathy (indifference, lack of interest) and lack of full emotional
      response. We will first take a brain scan to measure activity in different parts of the
      brain, while subjects are seeing pictures, using Magnetic Resonance Imaging (MRI) scan. Then
      we will add Wellbutrin XL - another well-known antidepressant that acts by increasing the
      chemical dopamine in the brain, to subjects' treatment. Wellbutrin addition is useful in
      decreasing the sexual side effects of SSRIs. After treatment with Wellbutrin XL for 6 weeks
      subjects will have a second MRI scan with picture rating.
    

Detailed description: 
      Hypotheses:

      Hypothesis 1.After wellbutrin XL addition for 6 weeks, SSRI treated subjects will show
      increased activation and connectivity of prefrontal cortex and limbic regions such as the
      amygdala on exposure to negative and positive pictures

      Hypothesis 2.Increase in activation of the MRC (Mood Regulating Circuit) will correlate with
      decrease in Apathy Evaluation Scale (AES) score and Sexual Dysfunction Score.

      We plan to study a maximum of 15 subjects in this study. SSRI treated depressed patients who
      after treatment of depression continue to suffer from sexual dysfunction and apathy will be
      included in the study. fMRI will be conducted at baseline and after addition of Wellbutrin XL
      treatment 300 mg po qd and then used at a dose of 300 mg - 450 mg from week 3 - 6 depending
      on response and tolerance. Patients will also be rated weekly on 17-item Hamilton Depression
      Rating Scale, Montgomery-Asberg Depression Rating Scale (MADRAS) (Montgomery and Asberg
      1979), AES (Marin et al 1991), Changes in Sexual Functioning Questionnaire (CSFQ) and
      Clinical Global Impression (Improvement) weekly for 6 weeks. Depressed patients will also be
      rated on the scan days on cognitive measures such as verbal memory and working memory.
    

Intervention name(s): Wellbutrin XL
Intervention type(s): Drug
Intervention MeSH terms: Bupropion
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mood Regulating Circuit; SSRI; fMRI
Comparative Study of PK and BE of VM-1500FDC (Fixed-dose Combination) and Elpida® With Truvada® сo-administrated 1 Daily Fasting in Healthy Subjects
Condition: HIV-1-infection
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label, randomized, parallel-group, comparative study of pharmacokinetics and
      bioequivalence of VM-1500FDC (elsulfavirine/emtricitabine/tenofovir fixed-dose combination)
      and Elpida® with Truvada® (emtricitabine/tenofovir) co-administered by healthy male subjects.
      The study will also assess safety profile of study drugs.
    

Detailed description: 
      The study assesses PK and bioequivalence of the developed new drug VM-1500FDC - a fixed
      combination of three active substances: elsulfavirine (NNRTI), emtricitabine (NRTI) and
      tenofovir (NRTI) to Elpida® and Truvada® co-administered. The combination is intended for
      once daily administration (1 tablet) for the treatment of HIV-1 infection in adult patients.
      Thus, the purpose of this combination is to simplify the dosage regimen and improve patient
      compliance
    

Intervention name(s): VM-1500FDC; Elpida®; Truvada®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A fixed-dose combination of three active substances: tenofovir 300 mg + elsulfavirine 20 mg + emtricitabine 200 mg, film-coated tablets; Elpida®, capsules, elsulfavirine 20 mg; Truvada® (tenofovir 300 mg / emtricitabine 200 mg), film-coated tablets
Other intervention name(s): VM1500FDC; VM-1500; VM1500; Elsulfavirine
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Elsulfavirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HIV -1; elsulfavirine fixed-dose combination
Dehydroepiandrosterone Supplementation for Poor Responder Patients During in Vitro Fertilization Treatment
Condition: Ovarian Stimulation
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the effect of dehydroepiandrosterone supplementation on
      in vitro fertilization performance and outcome among poor-responder patient.
    


Intervention name(s): dehydroepiandrosterone crystalline fine powder
Intervention type(s): Drug
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dehydroepiandrosterone; DHEA; IVF outcome; long protocol IVF; poor-responder; recombinant LH; embryo quality; pregnancy rate; live birth rate; poor response to ovarian stimulation