bioihbjkbjnl/mcl2 huggingface dataset:
Pilates and PNF Methods Induces Similar Strength Gains
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      To compare the influence of a training program with Pilates and PNF methods to elderly women
      on the strength gains and motor control during voluntary contractions
    

Detailed description: 
      Sixty healthy elderly women were randomly divided into 3 groups: Pilates group (PG), PNF
      group (PNFG) and Control group (CG). Pilates and PNF groups underwent one-month (three times
      per week) training program with Pilates and PNF methods, respectively. CG received no
      intervention along the one month. The maximal isometric force from knee extension and
      flexion, as well as the EMG signal from quadriceps and biceps femoris were recorded before
      and after the one-month intervention period. A two-way analysis of variance (3 groups x 2
      measures) was used to compare the results from EMG signal, isometric force and force
      variability and force spectrum. A one-month training program with Pilates and PNF methods
      induces similar strength gains from knee flexors and extensors, without differences between
      methods, but PG exhibited greater low gamma drive (i.e., 30-60 Hz band) after the training
      period. Both Pilates and PNF methods were efficient to improve the muscle strength, but with
      different neuromuscular adaptations in elderly women. These results give support to the
      recommendation these methods to older age groups, since the increment of lower limb muscle
      strength is important for gait, postural stability and performance of daily life activities
      of this population.
    

Intervention name(s): TRAINING PROGRAM
Intervention type(s): Other
Intervention description(s): Sixty healthy elderly women were randomly divided into 3 groups: Pilates group (PG), PNF group (PNFG) and Control group (CG). Pilates and PNF groups underwent one-month training program with Pilates and PNF methods, respectively. CG received no intervention along the one month.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: electromyography; aged; muscle strength; wavelet analysis; pilates; proprioceptive neuromuscular facilitation
The Effects of Atorvastatin in Patients With Atherosclerosis
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the effects of Atorvastatin.

      The investigators want to find out if atorvastatin has other helpful qualities. The
      investigators are interested in finding out if medicines like atorvastatin are useful even in
      people who do not have high levels of bad cholesterol and would like to understand other
      mechanisms by which this medicine helps prevent further blood vessel disease.

      Hypotheses:

        1. Atorvastatin reduces Rho kinase activity (in leukocytes) rapidly, within days, in
           patients with atherosclerosis.

        2. Any decrease in Rho kinase activity with statin therapy will be accompanied by
           improvement in familiar markers of atherosclerosis.
    

Detailed description: 
      The total study period is approximately 14 + 28 days. There will be a total of 5 visits: a
      screening visit, followed by visits at 0, 7, 14 and 28 days. (These dates may vary by
      approximately 2 days in the event of a weekend or holiday). At the baseline visit (day 0),
      patients will be randomly assigned to atorvastatin 10 mg/day (given as 1 placebo pill + 1
      10mg pill), 80 mg/day (given as 2 40mg pills) or placebo (given as 2 placebo pills). Subjects
      will be asked to take 2 pills every day at the same time between 7 p.m. and 8 p.m., and
      record in a calendar/diary any side effects, missed doses, change in concomitant medication,
      or any other pertinent information. At each visit, blood will be collected for the following
      tests: 1) Lipid profile, 2) C-Reactive protein, 3) Rho kinase expression and activity in
      leukocytes, 4) nitric oxide synthase (NOS) expression/activity in platelets, and 5)
      leukocyte/monocyte adhesion/migration assays. Blood for hepatic and muscle tests (ALT, GGT
      and CK) to monitor for side effects will be determined at baseline and at 28 days and as
      clinically indicated. At each visit, patients will be questioned about compliance with study
      medication and any side effects. All patients will be encouraged to adhere to the NCEP-ATPIII
      recommended therapeutic life style. Subjects will be asked to resume any statin medications
      they were taking prior to enrollment upon completion of the study.
    

Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Randomized Trial of Peer Led Education-Project Dulce
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of a culturally sensitive diabetes
      self-management program on glucose control and metabolic parameters in low income
      Mexican-Americans with type 2 diabetes using the Project Dulce model utilizing a low cost,
      peer-educator format.
    

Detailed description: 
      To recruit 207 Mexican-Americans patients from federally-funded community health centers in
      San Diego County with Hemoglobin A1c (HbA1c) > 8% and randomize to Project Dulce peer
      intervention or continuation of standard diabetes care. The primary outcome will be the
      percent change in HbA1c levels at 10 months following randomization.
    

Intervention name(s): Peer Education; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Conduct peer education classes for 8 weeks and support groups monthly for a total of 10 months and evaluate effects on metabolic and behavior outcomes; This group continues with standard care at the community health center
Other intervention name(s): Project Dulce
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: peer education; diabetes; randomized; trial
A Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer
    

Detailed description: 
      Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor
      Positive and HER2-negative Metastatic Breast Cancer
    

Intervention name(s): Docetaxel; Fulvestrant
Intervention type(s): Drug; Drug
Intervention description(s): 75mg/m2 D2 every 21 days; 500mg D1, D15, D29, D57, every 28 days later
Other intervention name(s): Taxotere; Faslodex
Intervention MeSH terms: Docetaxel; Fulvestrant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chemotherapy; Endocrine therapy; Docetaxel; Fulvestrant
A Phase 1, Randomized, Placebo-and Positive-Controlled Crossover Study to Determine the Effect of Single-Dose GC4419 on QTc Interval in Healthy Volunteers
Condition: Healthy Volunteers; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a partially double-blind study in healthy adult subjects, which will be conducted as
      a placebo- and active-controlled, single-dose, crossover study.

      Twenty-eight subjects will be enrolled to ensure 24 subjects on all study periods. All
      subjects will receive all 3 study treatments (GC4419, placebo and moxifloxacin) in randomized
      sequence.

      Cardiodynamic assessment using continuous ECG recordings (Holters) will be performed for
      approximately 26 hours on the day of dosing (Day 1) in each study period. ECGs will be
      extracted serially pre- and post-dose and predefined timepoints at which subjects will be
      supinely resting.

      Subjects will be supinely resting for at least 10 minutes prior to and 5 minutes after each
      nominal timepoint for ECG extraction.

      Blood draws for PK will be performed in all periods at the same timepoints and always after
      ECG extraction.

      Subjects will be domiciled in the clinic from noon/afternoon of the day before dosing (Day
      -1) until completion of safety procedures on Day 2 in each study period.

      All subjects (including subjects who terminate the study early) will return to the clinical
      research unit (CRU) 14 (± 1) days after the last administration of study treatment for
      follow-up procedures and to determine if any Adverse Event (AE) has occurred since the last
      study visit.
    


Intervention name(s): GC4419 IV; Placebo; Oral moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50mg infused IV over 15 minutes; Infused IV over 15 minutes; 400 mg tablet orally with 250 mL room temperature water
Intervention MeSH terms: Moxifloxacin; Avasopasem manganese
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Adult; Superoxide Dismutase; Free Radical Dismutase; Cardiodynamic Assessment
GDM Patients and Serum Amyloid A and Interleukin-1 (IL-1) Receptor Antagonist
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational
Study type: Observational

Summary: 
      Serum amyloid A and Interleukin-1 (IL-1) receptor antagonist (A-SAA and IL-1Ra) values;

        -  Comparison of pregnant women with and without GDM diagnosis

        -  Comparison of insulin therapy and diet-regulated GDM patients

        -  Comparison of pregnant women with and without LGA (large gestational age)

        -  Comparison of pregnant women with and without polyhydroamnios

        -  Investigation of its effect on pregnancy prognosis

        -  In the prediction of GDM diagnosis, it is aimed to study the sensitivity and specificity
           of both parameters and cut off values.

      (In GDM patients, liver and kidney function parameters will also be evaluated with A-SAA and
      IL-1Ra levels).
    


Intervention name(s): Serum amyloid A values; Interleukin-1 (IL-1) receptor antagonist values (A-SAA and IL-1Ra)
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Women who are diagnosed with GDM between the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.; Women who are diagnosed with GDM between the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Serum amyloid A (SAA) and Interleukin-1 (IL-1) receptor antagonist level will be examined
        in the study group consisting of pregnant women with GDM diagnosis and in the control group
        consisting of healthy pregnant women.
      
Keywords: Gestational Diabetes; Serum amyloid A; Interleukin-1 (IL-1) receptor antagonist
Study of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer
Condition: NSCLC Stage IIIB; NSCLC Stage IV; Hepatocellular Carcinoma by BCLC Stage; Lung Cancer; Liver Cancer
MeSH terms: Carcinoma; Lung Neoplasms; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I clinical study. Blood is drawn from the patient and brought to our
      laboratory for isolation of immune cells. These immune cells are then proliferated over a two
      week period and used to produce our patented product IKC (Immune Killer Cells). The IKC will
      then infused back into the patient to treat the cancer. Each patient will receive a total of
      six infusions.
    

Detailed description: 
      This is a phase I clinical study. Blood is drawn from the patient and brought to our
      laboratory for isolation of immune cells. These immune cells are then proliferated over a two
      week period and used to produce the patented product IKC (Immune Killer Cells). The IKC will
      then infused back into the patient to treat the cancer. Each patient will receive a total of
      six infusions.

      For each indication (cancer of the lung or liver) 10 patients are anticipated to be
      recruited, making a total of 20 subjects. All subjects will receive treatment as this is a
      single-arm study.
    

Intervention name(s): Immune Killer Cells (IKC)
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic and Safety Study of OMS201 in Subjects Undergoing Ureteroscopic Treatment for Removal of Urinary Tract-Located Stones
Condition: Urinary Calculi; Urinary Stones; Urinary Tract Stones
MeSH terms: Urinary Calculi; Urolithiasis; Calculi
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the safety and systemic absorption of OMS201 following exposure during ureteroscopy.
    

Detailed description: 
      OMS201 is being developed to facilitate endoscopy of the ureters and to reduce postoperative
      discomfort, such as pain, frequency, urgency and/or difficult urination following endoscopic
      surgery to remove a urinary tract stone.
    

Intervention name(s): OMS201; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): OMS201 irrigation solution during surgery; Vehicle irrigation solution during surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Urinary Calculi; Urinary Stones; Urinary Tract Stones; Calculi
Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting; Vitamin D Deficiency
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Vitamin D Deficiency; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Vitamin D is important risk factor for developing multiple sclerosis (MS) and for disease
      progression. Patients with MS who had lower vitamin D levels were at increased risk for more
      clinical attacks and faster disease progression. It was also shown that patients with MS had
      lower vitamin D levels in serum than healthy controls. It is not clearly defined, which are
      the levels of vitamin D in serum, that are high enough to trigger immunomodulatory effect and
      are safe for patients.

      This double-blind randomized clinical trial was designed to compare impact of vitamin D
      supplementation in two different doses (1000 IU/day vs 4000 IU/day) in patients with
      relapsing remitting MS. The main goal of this trial is to compare dose response on vitamin D
      supplementation and to estimate more closely appropriate level of vitamin D in serum which
      triggers some of experimentally shown immunomodulatory actions.
    

Detailed description: 
      Vitamin D is important risk factor for developing multiple sclerosis (MS) and for disease
      progression. Patients with MS who had lower vitamin D levels were at increased risk for more
      clinical attacks and faster disease progression. It was also shown that patients with MS had
      lower vitamin D levels in serum than healthy controls. It is not clearly defined, which are
      the levels of vitamin D in serum, that are high enough to trigger immunomodulatory effect and
      are safe for patients.

      This double-blind randomized clinical trial was designed to compare impact of vitamin D
      supplementation during four months in winter time in two different doses (1000 IU/day vs 4000
      IU/day) in patients with relapsing remitting MS. The main goal of this trial is to compare
      dose response on vitamin D supplementation and estimate more closely appropriate level of
      vitamin D in serum which triggers some of experimentally shown immunomodulatory actions. To
      define immunomodulatory response different laboratory, clinical and genetic tests will be
      performed.
    

Intervention name(s): Vitamin D
Intervention type(s): Drug
Intervention description(s): Vitamin D supplementation of 1000IU vs 4000IU vitamin D per day for four months during winter time, when levels of vitamin D in serum of MS patients are especially low.
Other intervention name(s): Oleovit D3
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1000 IU/day of Vitamin D vs 4000 IU of Vitamin D /day; IU (international units)
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Medical and Surgical Treatment of Esophageal Reflux
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Observational

Summary: 
      The purpose of this project is to lay the groundwork for a proposed clinical trial to compare
      the effectiveness of two approaches to gastroesophageal reflux disease: treatment with
      medications and treatment with anti-reflux surgery. This project includes a
      non-interventional pilot study to test ways of measuring outcomes of treatment, and to gauge
      potential participants' willingness to enroll in the proposed clinical trial.
    


Time perspective: Prospective
Keywords: Esophageal; Reflux
A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to assess the expected biological
      equivalence between two formulations of insulin degludec/liraglutide (IDegLira) with
      identical active ingredient in healthy volunteers.
    


Intervention name(s): insulin degludec/liraglutide; insulin degludec/liraglutide
Intervention type(s): Drug; Drug
Intervention description(s): Subject will receive a single injection (s.c.) of IDegLira B5; Subject will receive a single injection (s.c.) of IDegLira V2
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Liraglutide; Insulin, Long-Acting; Xultophy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX in Healthy Indian Children (V210-056)
Condition: Varicella
MeSH terms: Chickenpox
Study type: Interventional
Phase: Phase 3

Summary: 
      To observe the safety and tolerability of the administration of VARIVAX in varicella history
      negative Indian children 12 months to 12 years of age.
    


Intervention name(s): Varicella Virus Vaccine Live (Oka-Merck)
Intervention type(s): Biological
Intervention description(s): VARIVAX(TM) (Refrigerated) [Varicella Virus Vaccine Live (Oka/Merck), Refrigerator-Stable Formulation.] Subjects enrolled in the study received one 0.5 mL subcutaneous dose of VARIVAX(TM). Frequency is single dose.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study on Number and Outcome of Pregnancy in Acute Promielocitic Leukaemia (APL) Patients Treated With Chemotherapy
Condition: Acute Promyelocytic Leukemia; Pregnancy
MeSH terms: Leukemia; Leukemia, Promyelocytic, Acute
Study type: Observational

Summary: 
      The GIMEMA FOUNDATION promotes an observational (retrospective) study on number and outcome
      of pregnancy in childbearing age female patients treated with chemotherapy for APL. These
      patients were enrolled in studies AIDA0493, AIDA2000 and were in CR.
    

Detailed description: 
      Acute promielocitic leukaemia (APL) Among all the AML subtypes, APL has the distinction of
      being the most curable. The median age at diagnosis is 40 years, which is younger than with
      other AML subtypes. The fact that APL is more common in younger patients increases the
      likelihood that it may occur during fertile age. The introduction of ATRA and ATO has
      substantially modified the outcome of APL: in two successive studies 94% of patients achieved
      CR and the 6-yr OS rates (PETHEMA and GIMEMA) were about 80% 2,3,6.

      ATRA is highly effective in APL patients, but adverse effects such as retinoic acid syndrome,
      arrhythmias, headache, rash, dizziness have been reported. Moreover, retinoids are known to
      be potent teratogens and increased rates of spontaneous abortion and major fetal
      abnormalities have been reported 10. Most of the cases reported suggest that ATRA is
      relatively safe for both mother and fetus when used in the second and third trimesters. By
      contrast, when it was used in the first trimester, a negative foetal outcome was reported. No
      data have yet been reported on the outcomes of pregnancies in young patients with APL,
      occurring during CCR following ATRA-including chemotherapy regimens.

      APL therapy AIDA regimen: simultaneous Atra plus IDArubicin (AIDA) combination for induction
      treatment, followed by 3 courses of intensive chemotherapy as consolidation2.

      Consolidation therapy in the AIDA-0493 trial consisted of 3 chemotherapy courses with Ara-C
      and idarubicin3.

      Consolidation treatment in the AIDA-2000 was given according to a risk-adapted strategy as
      follows: patients with low-/intermediate-risk received the same 3 consolidation courses as in
      the AIDA-0493 but with omission of cytarabine; patients in the high-risk group received the
      identical 3 cycles as in the AIDA-0493.

      Study rationale This is an observational (retrospective) study on number and outcome of
      pregnancy in childbearing age female patients treated with chemotherapy for APL. These
      patients were enrolled in studies studies AIDA0493, AIDA2000 and were in CR.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients enrolled in studies AIDA0493, AIDA2000 in CR .
      
Keywords: Pregnancy; APL female patients