bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Proprioceptive Neuromuscular Facilitation in Older Women With Gonarthrosis
Condition: Osteoarthritis Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      To evaluate the effectiveness of the method Proprioceptive Neuromuscular Facilitation (PNF)
      as physical therapy approach to the reduction of pain and improvement in functional
      performance and quality of life in women with knee osteoarthritis.
    

Detailed description: 
      Patients will be divided into two groups: group perform proprioceptive neuromuscular
      facilitation and other group submit performing resistance exercises.
    

Intervention name(s): Proprioceptive neuromuscular facilitation (PNF); Resistance exercise
Intervention type(s): Other; Other
Intervention description(s): Proprioceptive neuromuscular facilitation, using the technique of rhythmic initiation and Combination of Isotonic on lower members; resistance exercise to strengthen lower limbs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Proprioceptive Neuromuscular Facilitation (PNF ); resistance exercise
Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda
Condition: HIV-infection/Aids
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Observational

Summary: 
      Current measures of adherence detect problems weeks to months after they occur. Because the
      HIV virus rapidly begins replicating and mutating in the absence of effective antiretroviral
      therapy, treatment failure may develop before an intervention can be deployed. Real-time
      objective adherence monitoring could redirect efforts from a reactive response to the
      proactive prevention of treatment failure. Because adherence is so closely associated with
      viral suppression, accurate adherence monitoring could also strategically limit viral
      monitoring only to those patients at a defined risk for viral rebound.

      This observational study is assessing a wireless adherence monitoring device and mobile
      phone-based adherence data collection among caregivers of children under the age of ten years
      in Mbarara, Uganda. It involves both quantitative and qualitative measures of the feasibility
      and acceptability of these measures, as well as circumstances of adherence lapses and other
      individual and cultural factors affecting adherence. The qualitative data will be used to
      explore models of adherence behavior, which will likely include the child-caregiver dynamic,
      the child's mental and physical health, and social support mechanism.
    

Detailed description: 
      See above.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        young children receiving HIV antiretroviral therapy in a rural African setting
      
Biospecimen description: 
      Plasma samples with HIV viral DNA.
    
Keywords: HIV/AIDS; pediatric; wireless adherence monitoring; HIV Infections
Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Marimastat may stop the growth of lung cancer by stopping blood flow to the tumor.
      It is not yet known if marimastat is an effective treatment for small cell lung cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of marimastat with a placebo
      following chemotherapy in treating patients who have small cell lung cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine whether treatment with the oral matrix metalloproteinase inhibitor
      (MMPI) marimastat prolongs overall survival and time to progression in patients with small
      cell lung cancer who have achieved complete or partial remission after first line
      chemotherapy, with or without radiotherapy. II. Determine the tolerability and toxicity of
      prolonged administration of marimastat in patients with small cell lung cancer. III.
      Determine the effect of prolonged administration of marimastat on the quality of life of
      patients with small cell lung cancer.

      OUTLINE: This is a randomized, double blind, multicenter, placebo controlled study. Patients
      are stratified by stage of disease at diagnosis, response to prior chemotherapy/radiotherapy,
      type of thoracic radiotherapy, and cooperative group. Patients are randomized into two
      groups. Half of the patients take marimastat orally twice a day (breakfast and evening meal);
      the other half take placebo orally twice a day (breakfast and evening meal). Treatment
      continues for 2 years or until documented disease recurrence or progression and institution
      of further anticancer treatment, occurrence of unacceptable toxicity, initiation of
      anticoagulant treatment, or development of intercurrent illness. All patients are followed
      every 6 months until death.

      PROJECTED ACCRUAL: The planned sample size is 360, with an equal number of patients in both
      arms, accrued at a rate of 240 responders per year (resulting in an accrual period of
      approximately 1.5 years). The total duration of the study is estimated as 2.3 years.
    

Intervention name(s): marimastat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg PO BID; 10 mg PO BID
Intervention MeSH terms: Marimastat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: recurrent small cell lung cancer
Pyronaridine-artesunate With Low Dose Primaquine for Preventing P. Falciparum Transmission
Condition: Malaria,Falciparum
MeSH terms: Malaria, Falciparum
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to assess the gametocytocidal and transmission reducing activity
      of pyronaridine-artesunate (PA) and dihydroartemisinin-piperaquine (DP) with and without a
      single low dose of primaquine (PQ; 0.25mg/kg). Outcome measures will include infectivity at 2
      and 7 days after treatment, the duration of infectivity in the artemisinin combination
      therapy (ACT) only arms, and the production and detectability of histidine rich protein II.
    

Detailed description: 
      Protocol will be shared on request
    

Intervention name(s): Pyronaridine Tetraphosphate/Artesunate; Dihydroartemisinin/Piperaquine; Primaquine Diphosphate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Adults: Tablets containing 180 mg pyronaridine-tetraphosphate/60mg artesunate (Pyramax, Shin Poong Pharmaceutical Co.), administered according to weight. Children: Granules containing 60 mg pyronaridine-tetraphosphate/20mg artesunate, administered according to weight.; Tablets containing 40 mg dihydroartemisinin/320 mg piperaquine tablets (Eurartesim, Sigma Tau), administered according to weight.; Extemporaneous preparation of 1mg/mL primaquine phosphate solution, from tablets containing 30mg primaquine (A-PQ 30®, ACE pharmaceuticals, NL) dissolved in 30mL water with a non-interacting fruit-flavoured syrup. Solution will be given at 0.25mg/kg.
Other intervention name(s): Pyramax; Euartesim; Primaquine
Intervention MeSH terms: Artesunate; Primaquine; Piperaquine; Artenimol; Pyronaridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Primaquine; Pyramax; Euartesim; Dihydroartemisinin-piperaquine; Pyronaridine-artesunate
Low-dose Apatinib Combined With Neoadjuvant Chemotherapy in the Treatment of Early Triple Negative Breast Cancer
Condition: Triple-Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Triple-negative breast cancer (TNBC) is a special type of breast cancer, endocrine therapy
      and targeted therapy are completely ineffective, chemotherapy is currently the only effective
      treatment. How to improve postoperative pathologic complete response（pCR）of neoadjuvant
      chemotherapy is critical problem to prolong event-free survival (EFS) and overall survival
      (OS) of TNBC patients. Apatinib is a new oral small molecule tyrosine protease inhibitor, it
      is effective in inhibiting angiogenesis with a very low concentration. So the standard
      neoadjuvant chemotherapy regimen of docetaxel and carboplatin combined with apatinib may
      improve the postoperative pCR and survival outcomes of TNBC patients. Safety and tolerability
      assessed by number of grade 3 and 4 toxicities and hospitalizations.
    

Detailed description: 
      All enrolled patients were administered oral apatinib at a dose of 250 mg once daily and
      intravenously docetaxel (100 mg/m2) every three weeks for four cycles, followed by epirubicin
      (90 mg/m2) plus cyclophosphamide (600 mg/m2) every three weeks for four cycles. All the
      treatments were continued until disease progression, patient withdrawal, or unacceptable
      toxic effects. Granulocyte colony-stimulating factor (G-CSF) used for prophylaxis of febrile
      neutropenia was permitted according to the American Society of Clinical Oncology (ASCO)
      guidelines. The biochemical and hematological indexes were evaluated every cycle. Dose
      modifications of chemotherapy agents, including dose interruptions and dose reductions, were
      permitted due to certain adverse events.
    

Intervention name(s): Apatinib
Intervention type(s): Drug
Intervention description(s): All enrolled patients were administered oral apatinib at a dose of 250 mg once daily and intravenously docetaxel (100 mg/m2) every three weeks for four cycles, followed by epirubicin (90 mg/m2) plus cyclophosphamide (600 mg/m2) every three weeks for four cycles. All the treatments were continued until disease progression, patient withdrawal, or unacceptable toxic effects.
Intervention MeSH terms: Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Triple-Negative Breast Cancer; apatinib; pCR; OS; Neoadjuvant chemotherapy
Gait in Low Back Pain Patients After Spinal Mobilization
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Introduction: patients with chronic back pain as a result of degenerated disc disease,
      besides pain also present with impaired gait. The purpose of this study is to evaluate both
      the clinical data using clinical rating scales, such as Oswestry Disability Index Greek
      version (ODI), Numerical Pain Rating Scale for low back pain and leg pain (NPRS) and the
      Roland Morris Disability Questionnaire Greek Version, and kinetic and kinematic
      characteristics during gait analysis in patients with chronic low back pain as a result of
      the degenerated disc disease (Disc Degenerative Disease), before and after application of
      manual therapy techniques.

      Methodology: for the purposes of the study, 75 patients suffering from chronic low back pain
      were randomly divided into 3 groups of 25 each. Each group received five sessions with the
      first group receiving manual therapy treatment (spinal mobilisation), the second a sham
      treatment and the third, classic physiotherapy (stretching exercises, TENS and massage). To
      evaluate the effectiveness of each treatment, the visual analog pain scale, two
      questionnaires (Oswestry and Roland Morris) and also an optoelectronic system for recording
      and analysis of gait (kinetic and kinematic data) were utilized.
    

Detailed description: 
      This was a randomized controlled trial comparing the efficacy of spinal mobilization with
      other physiotherapy interventions (stretching, TENS application and Swedish type massage) and
      sham treatment in a group of chronic low back pain patients. The outcome measures included
      three dimensional gait analysis (kinetic and kinematic data) as well as clinical indicators
      (numerical pain rating scale, Oswestry disability index, Roland-Moris Disability
      questionnaire).
    

Intervention name(s): TENS; spinal mobilization; swedish type massage; static hamstring stretch; sham treatment
Intervention type(s): Device; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Enraf-Nonius Sonopuls 692; passive physiological intervertebral movements and passive accessory posteroanterior mobilization; petrissage, effleurage, tapotement; static hamstring stretching; touching of the skin overlying the lumbar area
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: spinal mobilization; manual therapy; gait analysis; low back pain; chronic
The GLOBAL Vitamin D Study. A Genomic, Transcriptomic, Proteomic and Metabolomic Approach
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      The effect of vitamin D supplementation on genetic, proteomic , and metabolomic profile in
      adipose tissue will be studied in 50 subjects.
    

Detailed description: 
      Vitamin D is a hormone with effects not only on the skeleton, but on most tissues in the
      body. Lack of vitamin D is associated with coronary heart disease, cancer and immunological
      diseases, and also with obesity, hypertension and glucose intolerance. However, to see the
      full effect of vitamin D, one should not only look at single diseases or risk factors, but
      have a global approach using a combined clinical index. A similar line of thinking can be
      applied to genetic, proteomic and metabolomic studies on vitamin D. Thus, in the present
      study 50 subjects will be included and randomized to vitamin D 40.000 IU per week versus
      placebo for 2 months. Blood and adipose tissue samples will be collected before and after the
      intervention and analyzed for gene expression. Based on these results the investigators will
      proceed with the relevant proteomic and metabolomic profile analyses. If successful, this may
      reveal new aspects of vitamin D's physiology and metabolic effects.
    

Intervention name(s): Cholecalciferol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vitamin D preparation; placebo
Other intervention name(s): Dekristol
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: vitamin D; genomics; proteomics; metabolomics; adipose tissue
Modulation of Behavioral Inhibition in Attention Deficit Hyperactivity Disorder
Condition: ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The main purpose of this study is to investigate how the brain responds to a procedure known
      as transcranial direct current stimulation (tDCS) and how tDCS affects performance on a
      behavioral task. Research suggest that this procedure leads to improvement in brain and
      behavioral measures of inhibitory control (controlling impulses) in healthy control
      participants. The investigators want to explore whether the same improvement will be seen in
      kids with ADHD.
    


Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients with ADHD
      
Keywords: Attention Deficit Hyperactivity Disorder (ADHD)
Correction of Exercise-induced Desaturation by Acute Oxygen Supply and Exercise Responses in COPD
Condition: Chronic Obstructive Pulmonary Disease; Oxygen/Therapeutic Use
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      In the literature, the effects of acute oxygen administration on exercise tolerance and
      related symptoms have often appeared to be contradictory. Some investigations have reported
      benefits from acute oxygen supply during exertion, including increased exercise performance,
      reduced dyspnea, and better cardiorespiratory adaptations, whereas other studies have
      reported no improvement. Recently, we advanced then the hypothesis that some patients would
      be non-responders and even worsen under oxygen treatment. The preliminary results confirmed
      our hypothesis since we demonstrated that while 56% of the patients were improved with
      supplemental oxygen, 16% were non-responders and 28% were negative-responders (decreased
      performance and increased dyspnea during endurance exercise with supplemental oxygen).
      However, this was a pilot study offering preliminary insights and tentative conclusions that
      must be confirmed in a larger case series.

      The aims of this retrospective study was :

        1. To confirm on cohorte and with clinical test (the 6-minute walking test - 6WT) the
           deleterious responses to acute oxygen supplementation in LTOT (long terme oxygenotherapy
           treatment) and non-LTOT patients who exhibit exercise desaturation.

        2. To identify the predictive factors among the clinical data (i.e., anthropometric,
           spirometric and gazometric data) and/or functional data recorded during rehabilitation
           program
    

Detailed description: 
      During this study, a retrospective data collection will be carried out using the informations
      contained in the medical folders of patients admitted in our centers for pulmonary
      rehabiliation program.

      We will select patients who meet the following criteria:

      A) patients having two 6WT early in their program B) who desaturate (SpO2 <90% for 3
      consecutive min) during the first 6WT and who will have been properly corrected with a supply
      of oxygen during the second walk test.

      The analyzed parameters will be distance and dyspnea during the tests
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with chronic obstructive pulmonary disease and exhibiting an exercise-induced
        desaturation during six minute walkink test.
A Study To Evaluate The PDE10 Enzyme Occupancy Following A Single Dose Of PF-02545920 In Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study will evaluate PDE10 enzyme occupancy using Positron Emission Tomography
      after a single dose of PF-02545920 in Healthy male volunteers.
    


Intervention name(s): 20 mg PF-02545920; PF-02545920; PF-02545920
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subject will receive a single dose of 20 mg PF-02545920.; The dose will be selected based on the results obtained for Cohort 1. Dose options range from 30 mg to 10 mg, 5 mg, 2mg, 1 mg.
This cohort is optional.; The dose will be selected based on the results obtained for Cohort 1 and cohort 2.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Enzyme occupancy; PET; Phosphodiesterase 10 inhibitor
Glasdegib Renal Impairment Study
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to administer single dose (100 mg) glasdegib tablet to subjects
      with normal, moderate and severe renal impairment and estimate the effect, if any, of this
      renal impairment on glasdegib pharmacokinetics.
    


Intervention name(s): Glasdegib single 100 mg dose in normal healthy subjects; Glasdegib single 100 mg dose in moderate renal impairment subjects; Glasdegib single 100 mg dose in severe renal impairment subjects
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose of 100 mg glasdegib tablet will be administered after an overnight fast, followed by serial PK collection, discharge and follow -up.; A single dose of 100 mg glasdegib tablet will be administered to subjects with moderate renal impairment, after an overnight fast, followed by serial PK collection, discharge and follow -up.; A single dose of 100 mg glasdegib tablet will be administered to subjects with severe renal impairment, after an overnight fast, followed by serial PK collection, discharge and follow -up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Glasdegib; PF-04449913; Pharmacokinetics; Renal Impairment
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Male Subjects
Condition: Healthy Male Subjects; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, randomised, single-blind, placebo-controlled, first-in-human (FIH) single
      and multiple ascending dose study consisting of two parts (Part A [SAD] and Part B [MAD]) to
      assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5718 in healthy
      male subjects
    

Detailed description: 
      This is a phase I, randomised, single-blind, placebo-controlled, first-in-human (FIH) single
      and multiple ascending dose study consisting of two parts (Part A [SAD] and Part B [MAD]) to
      assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5718 in healthy
      male subjects
    

Intervention name(s): AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A); AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A); AZD5718 placebo oral suspension; AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral suspension single dose; Single and multiple doses; Single and multiple doses; Single and multiple doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: AZD5718 oral suspension crystalline; AZD5718 oral suspension amorphous; Single ascending dose/multiple ascending dose (SAD/MAD); Placebo-controlled; Safety; Tolerability; Pharmacokinetics; Pharmacodynamics
Oral Nutritional Supplementation of Hemodialysis Patients
Condition: Hemodialysis Complication
Study type: Interventional

Summary: 
      This study is aimed to demonstrate that increase in serum albumin concentration (week 8
      -baseline) after test treatment (Fresubin® Protein Energy DRINK), a standard ONS, is not
      relevantly smaller than that after control treatment with NEPRO®.
    


Intervention name(s): Fresubin® Protein Energy DRINK; NEPRO® , Abbott
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1-2 bottles of Fresubin® Protein Energy DRINK per day; 2-4 cans NEPRO® per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment