bioihbjkbjnl/mcl2 huggingface dataset:
Knee Extensor Muscle Properties in Young Women Symptomatic and Asymptomatic for Anterior Knee Pain
Condition: Anterior Knee Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome
Study type: Observational

Summary: 
      This study aims to compare the knee extensors' mechanical, morphological and myoelectric
      properties between subjects affected by anterior knee pain and a healthy control group. The
      investigators hypothesis is that patients with anterior knee pain present a reduction in the
      knee extensors' mechanical, morphological and myoelectric properties due to chronic muscle
      inhibition produced by the syndrome. In addition, the study also aims to evaluate whether
      there are differences in methodology for application of the Interpolated Twitch Technique for
      evaluation of the quadriceps muscle inhibition by comparing the use of supramaximal
      electrical stimulation on the femoral nerve (gold standard) with stimulation on the motor
      point (new methodology) in healthy subjects and individuals affected by anterior knee pain.
      The investigators hypothesis is that the stimulation on the motor point is less
      discomfortable than on the femoral nerve and muscle inhibition results are less variable
      (with lower dispersion) due to such lower discomfort
    

Detailed description: 
      Participants were divided in two groups (control group, n=16 and anterior knee pain group,
      n=16). Prior to participation, informed consent was obtained from all subjects. The
      evaluation was performed at the lower limb with severe symptoms of anterior knee pain in the
      patients, and at the dominant limb in the control group. Quadriceps Muscle inhibition was
      estimated using the Interpolated Twitch Technique, which involves applying a single
      electrical twitch stimulation to the femoral nerve (gold standard) during a maximal isometric
      knee extensor contraction. Muscle inhibition measurements were obtained with the aid of a
      Grass S88 (Quincy, MA, USA.) Muscle Stimulator in combination with and isolation unit
      approved for human use. Isometric and isokinetic knee extensor torques were obtained with a
      Biodex System 3 dynamometer (Biodex Medical System, Shirley - NY, USA). Electromyographic
      muscle activity was measured with bipolar surface electrodes (Kendall, Meditrace - 100;
      Ag/AgCl) that were placed on the muscle bellies of vastus medialis, vastus lateralis and
      rectus femoris. Muscle architecture was measured with a B-mode ultrasonographic system (SSD;
      Aloka Inc., Tokyo, Japan) with a linear-array probe (60 mm, 7.5MHz; Aloka). Single Leg Squat
      was used for clinical evaluation of the lower limb functionality.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Young women symptomatic and assymptomatic for anterior knee pain syndrome
      
Keywords: Anterior Knee Pain Syndrome; Quadriceps Femoris; Muscle Inhibition; Interpolated Twitch Technique; Muscle Architecture; Single Leg Squat; Women Knee Pain
Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to understand, with the use of functional magnetic resonance
      imaging, the neural correlates involved in appetite control and the mechanism of weight gain
      in patients with schizophrenia treated with atypical antipsychotics. We hypothesize that a
      difference in cerebral activations between weight gaining and non-weight gaining patients
      will be detected after four months of treatment with olanzapine.
    

Detailed description: 
      Atypical antipsychotics (AAP) have revolutionize treatment of schizophrenia. They are
      considered to be more effective in reducing positive and negative symptoms and in improving
      cognitive deficits. They cause less extrapyramidal symptoms and tardive dyskinesia than
      typical antipsychotics. They still have a lot of important side effects like sedation,
      metabolic syndrome and weight gain. These effects could lead to obesity, type II diabetes and
      cardiovascular diseases, particularly for schizophrenia patients because they are already at
      an increased risk for these complications. Moreover, an increase in weight gain has been
      demonstrate to exacerbate negative symptoms and can lead to non compliance with a consequent
      risk of relapse. It also can create an additional social disadvantage for schizophrenia
      patients and decrease their quality of life. The weight gain will result, in part from an
      increased food intake (and probably an increased appetite) and from a decreased energy
      expenditure.

      The purpose of this study is to understand the cerebral mechanisms of appetite in patients
      with schizophrenia treated with atypical antipsychotics to prevent or treat their weight
      gain.
    

Intervention name(s): Olanzapine
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Schizophrenia; Atypical antipsychotics; Weight gain; Appetite; fMRI
Study of ORIC-101 in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      ORIC-GR-17001 is an open-label, single center, non-randomized, single ascending dose study in
      healthy male subjects and healthy female subjects of non-child bearing potential. In this
      study, ORIC-101 will be administered as single-ascending oral doses. The primary objective is
      to characterize the safety and tolerability of oral ORIC-101.
    

Detailed description: 
      This is an open-label, single center, non-randomized, single ascending dose study in healthy
      male subjects and healthy female subjects of non-child bearing potential.

      Subjects will receive a single administration of ORIC-101 oral suspension on a single
      occasion and will be followed in the clinic for at least 96 hours post-dose. Total subject
      participation will be approximately 5 weeks from screening until discharge from the study.

      The primary objective of the study is to characterize the safety and tolerability of oral
      ORIC-101 administered as a single dose in adult healthy subjects. The secondary objective of
      the study is to evaluate the pharmacokinetics of ORIC-101 and its metabolites M1 and M2. The
      exploratory objective of the study is to assess the pharmacodynamics of ORIC-101 by
      measurement of serum and urine levels of cortisol and other biological markers in healthy
      subjects
    

Intervention name(s): ORIC-101
Intervention type(s): Drug
Intervention description(s): Oral suspension
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      1. To determine if the effect of near-addition lenses (bifocals) is more prominent for
           children with high myopia progression.

        2. To study how different subject characteristics such as age, gender, baseline degree of
           myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of
           bifocal lens wear in myopic children.

        3. To investigate the effect of incorporating near base-in prisms along with the
           near-addition lenses (prismatic bifocals) on myopia progression in myopic children.
    


Intervention name(s): Bifocal spectacles; Prismatic bifocal spectacles
Intervention type(s): Device; Device
Intervention description(s): +1.50D bifocal spectacles; +1.50D bifocal spectacles combined with 3Δ base-in prisms
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myopia, bifocal, children
Reflexology and Quality of Life
Condition: Diabetic Foot
MeSH terms: Diabetic Foot
Study type: Interventional

Summary: 
      This is a randomized, controlled and blind clinical trial with 60 type 2 diabetes patients
      divided into 2 groups of 30 patients each, Control Group (CG) and Treatment Group (TG). The
      TG will receive self-care guidelines with feet and 12 sessions of foot reflexology, while the
      CG will only receive the guideline.
    

Detailed description: 
      The purpose of this study is to evaluate the effects of reflexology on the quality of life
      and functional capacity of patients at risk for diabetic neuropathy. This is a randomized,
      controlled and blind clinical trial with type 2 diabetes patients. The eligibility criteria
      are 10 years or more of diagnosis of diabetes mellitus, between the ages of 50 to 75 years,
      both sexes, and registered in the Primary Health Care Unit of São João or in the Diabetes
      Education Center in Minas Gerais state, Brazil. As exclusion criteria, it will be considered
      the presence of ulcers in the feet, amputations of the lower limbs, deficits in cognitive
      abilities, and previous treatment using reflexology. For the calculation of the sample size,
      a pilot test will be conducted with 8 diabetic patients. It will be used the statistical
      software Biostat® 5.3. The sample found was of 60 patients who were divided into 2 groups of
      30 patients each, Control Group (CG) and Treatment Group (TG). The TG will receive self-care
      guidelines with feet and 12 sessions of foot reflexology, while the CG will only receive the
      guideline. For the evaluations, it will be applied the instrument for quality of life (SF-36)
      and for functional capacity, the Stanford Health Assessment Questionnaire. This research will
      follow the standards set by resolution 466/12 of the National Health Council, for research
      with human beings and will be conducted in accordance with the ethical recommendations of the
      Declaration of Helsinki.
    

Intervention name(s): reflexology; self-care guidelines with feet
Intervention type(s): Other; Other
Other intervention name(s): massage; education
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be taken to a room reserved for the procedure. First, the patients answer the research instruments and then they will be asked to lie supine on a stretcher. The feet of the patients will be cleaned with water (37ºC) and mild soap and then will be dry with paper towels. The next phase consists in the application of foot massage, that will follow the Lourenço's Protocol (2012), which consists of 14 steps of relaxation massage. Each step will have duration of 1 minute, 3 procedures by week, by 4 consecutive weeks. The research instruments, SF-36 and Stanford Health Assessment Questionnarie will be applied before the first and after the last procedure.
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Reflexology,diabetes, quality of life
Chiropractic for Hypertension in Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The investigators propose a prospective randomized 2 arm parallel observer-blinded phase II
      clinical study comparing a distinct method of upper cervical chiropractic manipulation to a
      sham technique in 50 individuals with stage I hypertension (systolic blood pressure (SBP):
      140-159 mm Hg; diastolic blood pressure (DBP):90-99 mm Hg).
    

Detailed description: 
      More than 50 million Americans suffer from hypertension, a disease with far-reaching public
      health impact causing or contributing to 7.1 million deaths yearly at an estimated annual
      incremental direct cost of $54 billion per year. Common treatments include antihypertensive
      medications and lifestyle modifications. While these treatments have been shown to be
      effective, only about 30% of hypertensive patients achieve blood pressure goals. Based on a
      recently published study (Bakris et al, 2007), one unique non-pharmaceutical approach may be
      a non-rotary type of upper cervical spinal manipulation to align the first cervical vertebra
      (atlas) performed by a doctor of chiropractic. We propose to conduct a similar study with a
      more commonly known chiropractic technique called Toggle Recoil. We propose a prospective
      randomized 2 arm parallel observer-blinded phase II clinical study comparing a distinct
      method of upper cervical chiropractic manipulation to a sham technique in 50 (25 in each
      group) individuals with Stage I hypertension (systolic blood pressure (SBP); 140-159 mm Hg or
      diastolic blood pressure (DBP):90-99 mm Hg). Patients will be seen by doctors of chiropractic
      twice each week for 6 weeks and outcomes will be collected at baseline, 3 weeks, and 6 weeks
      after enrollment. The primary outcome measure will be change in SBP and the primary endpoint
      will be at the week 6 assessment.
    

Intervention name(s): Spinal Manipulation; Sham Spinal Manipulation
Intervention type(s): Other; Other
Intervention description(s): The procedure in its broadest definition describes the application of a load (force or displacement) to specific body tissues (usually vertebral joints) with therapeutic intent. The mechanical characteristics of SM can vary in terms of its duration and amplitude, (hence, the rate at which it is applied), as well as its anatomical location, choice of levers, direction of force application, and the vehicle used to apply the force (manually or mechanically assisted).; The sham assessment procedures will be the same as those in the high velocity treatment group. The sham intervention is identical to this treatment protocol except for the placement of the treating clinicians pisiform contact. The force and vector applied will be the same.
Other intervention name(s): Sham
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension
Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Bosutinib Administered Orally to Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study to determine if a high-fat meal has an effect on the pharmacokinetics of bosutinib.
    


Intervention name(s): Bosutinib; Bosutinib
Intervention type(s): Drug; Drug
Intervention description(s): Bosutinib fasting; Bosutinib fed
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Smart Device-based Cardiac Rehabilitation After Myocardial Intervention
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the influence of cardiac rehabilitation based on smart
      band use and telemonitoring on functional capacity change and risk factors control among
      patients hospitalized for acute myocardial infarction.
    


Intervention name(s): Smart device-based cardiac rehabilitation
Intervention type(s): Device
Intervention description(s): A smart device coupled with remote monitoring will be used to increase physical activity of patients after myocardial infarction with a history of low physical activity.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myocardial infarction; cardiac rehabilitation; smart device; remote monitoring; telemonitoring; low physical activity; risk factors control
Management of Slipped Capital Femoral Epiphysis (SCFE) on Top of Fixed Fracture Neck of Femur Case Report.
Condition: Slipped Capital Femoral Epiphysis
MeSH terms: Slipped Capital Femoral Epiphyses; Femoral Neck Fractures
Study type: Interventional

Summary: 
      Slipped Capital Femoral Epiphysis (SCFE) on Top of Fixed Fracture Neck of Femur managed by
      subtrochanteric valgus osteotomy
    

Detailed description: 
      The incidence of Slipped capital femoral epiphysis (SCFE) after management of femoral neck
      fracture in pediatrics is very rare. In this case report, a 9-year-old female child sustained
      left sided femur neck fracture after a motor car accident. The fracture was fixed by two
      cannulated screws and healing with mild varus occurred after 1.5 months. However, progressive
      slippage of femoral epiphysis was observed. This was treated by subtrochanteric valgus
      osteotomy
    

Intervention name(s): subtrochanteric valgus osteotomy
Intervention type(s): Procedure
Intervention description(s): subtrochanteric valgus osteotomy
Intervention model: Single Group Assignment
Intervention model description: subtrochanteric valgus osteotomy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Slipped capital femoral epiphysis; SCFE; coxa vara; fracture neck of femur
Bioequivalence Study of Topiramate Tablets 25mg Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was to compare the single-dose relative bioavailability of
      Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg topiramate tablets following a 50 mg
      dose under fed conditions.
    

Detailed description: 
      This was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability
      study performed on 18 healthy adult male volunteers. A total of 17 subjects completed the
      clinical phase of the study. In each period, subjects were housed from the evening before
      dosing until after the 24-hour blood draw. Subjects were to return for the 48-, 72-, 96- and
      120-hour blood draws. Both periods were separated by a washout period of 14 days.
    

Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention description(s): 25mg tablets
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Topiramate fed study
Benidipine-based Comparison of Angiotensin Receptors, β-blockers, or Thiazide Diuretics in Hypertensive Patients
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      A number of major clinical trials have demonstrated the clinical benefits of lowering blood
      pressure and have indicated that a majority of patients with hypertension will require more
      than one drug to achieve optimal blood pressure control.

      There is little data showing which antihypertensive combination best protects patients from
      cardiovascular events and which best achieves the target blood pressure with the fewest
      adverse events.

      The COPE trial is planned to investigate, in patients with hypertension, which combination of
      the antihypertensive drugs, angiotensin receptor blockers, β-blockers or thiazide diuretics
      in addition to a long-acting calcium antagonist, benidipine hydrochloride, is superior to
      achieve the targeted blood pressure and prevent cardiovascular events with the fewest adverse
      drug effects.
    


Intervention name(s): Angiotensin receptor blockers; β-blockers; thiazide diuretics
Intervention type(s): Drug; Drug; Drug
Intervention description(s): benidipine+angiotensin receptor blocker, titlation scheme; benidipine+β-blockers, titlation scheme; benidipie+thiazide diuretics, titlation scheme
Other intervention name(s): benidipine, angiotensin receptor blockers; benidipine, β-blockers; benidipie, thiazide diuretics
Intervention MeSH terms: Benidipine; Diuretics; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Adrenergic beta-Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypertension; Multicenter clinical trial; PROBE; Combination therapy; Benidipine; Essential Hypertension
Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) in Progressive Supranuclear Palsy (PSP) (STIM-PSP)
Condition: Progressive Supranuclear Palsy; Motor and Cognitive Symptoms
MeSH terms: Paralysis; Supranuclear Palsy, Progressive; Neurobehavioral Manifestations
Study type: Interventional

Summary: 
      This is a double-blind, randomized, sham-controlled clinical trial that aim to verify the
      safety and the efficacy of anodal transcranial direct current stimulation (tDCS) on cognitive
      and motor symptoms in Progressive Supranuclear Palsy (PSP) over the left dorsolateral
      prefrontal cortex (dlPFC).
    

Detailed description: 
      Progressive Supranuclear Palsy (PSP) is a rapidly progressive neurodegenerative disease
      characterized by deposition of tau and motor, cognitive and behavioral symptoms. Since no
      effective treatment is available, non-invasive brain stimulation techniques, such as tDCS,
      could be a valid complementary therapeutic approach. The tDCS modulates the spontaneous
      activity of the neural network by applying a direct current flow on the cortical brain areas
      (anodic or cathodic stimulation). Despite its efficacy in psychiatric disorders, the
      therapeutic use of tDCS in neurodegenerative diseases requires more systematic studies. The
      aim of this study is to verify the safety and efficacy of tDCS in PSP on motor, cognitive and
      behavioral symptoms.
    

Intervention name(s): Anodal transcranial direct current stimulation (a-tDCS); Sham Condition
Intervention type(s): Device; Device
Intervention description(s): tDCS is delivered by a battery-driven constant current stimulator thought a pair of saline soaked surface sponge electrodes. The active electrode (anode) is placed on the scalp over the left dlPFC (F3) according to the 10 to 20 international electroencephalogram coordinates) and the cathode is placed over the right deltoid muscle. During real stimulation a constant current of 2mA (milli Ampere) is applied for 20 minutes.; For the sham condition the electrode placement is the same of active tDCS but the electric current is ramped down 5 seconds after the beginning of the stimulation.
Other intervention name(s): Active tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be recruited and randomized in two parallel group: group 1 will receive anodal left dlPFC tDCS (real tDCS) and group 2 will receive sham stimulation for 5 days/week for 2 consecutive weeks, in a 2:1 ratio, respectively. Each participant will undergo a clinical evaluation at baseline (T0), immediately after 2 weeks of either real or sham tDCS (T1), at 45-day (T2) and at 3-month follow up (T3) from baseline. PSP phenotypes will be uniformly distributed between treatment arms (ie, =Richardson's syndrome versus non-Richardson's syndrome=1:1).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Progressive Supranuclear Palsy (PSP); Transcranial direct current stimulation (tDCS)