bioihbjkbjnl/mcl2 huggingface dataset:
Functional Impact of a Memory Intervention Program
Condition: Aging
Study type: Interventional

Summary: 
      Normal aging is associated with decline in some aspects of memory, and this can be a risk
      factor for reductions in everyday functioning. The Baycrest Memory and Aging Program teaches
      positive adaptation to age-related memory changes, including strategies for minimizing the
      everyday impact of normal memory change and positive lifestyle change to maximize brain
      health. Prior research has shown that the Memory and Aging program is effective in increasing
      participants' knowledge about memory, use of memory strategies, and confidence in memory
      function, as well as adoption of healthier lifestyle practices and reduction in intention to
      use unneeded health care resources.

      Although not one of the stated goals of the program, informal feedback from participants
      suggests that the educational content and skills training in the Memory and Aging Program has
      led some participants to change behaviours in ways that lead to significant improvements in
      their everyday functioning. For example, graduating participants often volunteer examples of
      how they have applied what they have learned to succeed in everyday memory tasks such as
      learning a new name or keeping track of future plans. Based on this participant feedback, it
      is hypothesized that the knowledge, skills, and confidence gained by Memory and Aging Program
      participants may lead to positive behaviour changes that, in turn, lead to improved everyday
      functioning. The present study will test this hypothesis using a randomized controlled
      pretest-posttest design.
    


Intervention name(s): Memory and Aging Program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: aging; memory; memory training
Study to Assess the Efficacy and Safety of Treatment of Articular Cartilage Lesions With CartiLife®
Condition: Articular Cartilage Lesion of the Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and efficacy of implanting bead-type
      autologous chondrocyte (CartiLife®) obtained by culturing expanded costal chondrocytes of the
      patient with a chondral defect in the knee. The patients will be assessed clinically using
      MRI, clinical, biochemical and International Knee Documentation Committee(IKDC) outcomes
      preoperatively as well as 8, 24 and 48 weeks postoperatively to assess the relief of symptoms
      and joint function.
    


Intervention name(s): CartiLife®; Microfracture
Intervention type(s): Drug; Procedure
Intervention description(s): CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted the volume of 1 cm3 per the capacity of the syringe to the affected area through injection with fibrin adhesive through minimal arthrotomy.; The surgery is performed by arthroscopy, after the joint is cleaned of calcified cartilage. Through use of an awl, the surgeon creates tiny fractures in the subchondral bone plate.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Biological: CartiLife® Procedure: CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted in a volume of 1 cm3 per the capacity of the syringe to the affected area through injection along with a fibrin adhesive through minimal arthrotomy.
Active comparator: Microfracture The surgery is performed by arthroscopy, after the joint is cleaned of calcified cartilage. Through use of an awl, the surgeon creates tiny fractures in the subchondral bone plate.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Degenerative Arthritis; Autologous Chondrocyte Implantation; Cartilage defects; Cartilage lesion; Arthritis
Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to investigate the effect of postoperative concurrent
      chemoradiotherapy versus radiotherapy alone for patients with locally advanced esophageal
      squamous cell carcinoma.
    


Intervention name(s): Docetaxel plus cisplatin; radiotherapy
Intervention type(s): Drug; Radiation
Intervention description(s): cisplatin 25mg/m2 on day 1 and docetaxel 25mg/m2 on day 1 weekly for 5 weeks; radiotherapy: 50Gy (2.0 Gy/fraction, 5 days a week)
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: esophageal neoplasma; adjuvant therapy; chemotherapy; radiotherapy
Vascularity of the Ulna and Its Association With Forearm Nonunion
Condition: Forearm Fracture
Study type: Observational

Summary: 
      Non-union after operative treatment of an ulnar fracture is very uncommon. There are severely
      disabling and challenging to treat. Multiple factors have been associated with the
      establishment of this non-union. Many non-unions are associated with soft tissue damage,
      fracture site vascularity, persistent instability, infection, and the surgical treatment
      technique. This study analysed the systemic conditions and local factors associated with the
      failure of bone fracture healing The aim of our study was to identify the risk factors for
      ulnar nonunion
    

Detailed description: 
      In the anatomical study we investigated the extraosseous and intraosseous blood supply in
      fourteen specimens from the Department of Human Anatomy. We correlated the areas with a low
      vascularity with the usual areas that patients have ulnar nonunion.

      In the clinical study we retrospectively reviewed a cohort of ulnar fractures treated
      surgically with open reduction and internal fixation (ORIF), during a period of 10 years
      (2007-2016). We identified 211 ulnar fractures. All patients had a minimum follow-up of 1
      year. We defined non-union if there was no radiological consolidation of the fracture after
      this period, and we classified them according to Weber classification. We assessed risk
      factors like: fracture site vascularity, surgical treatment technique, biological factors of
      the patient, and the fracture's mechanism. We correlated data and associated risk factors
      from the anatomical and the clinical studies.

      Data were analysed using SPSS software system version 21. Multivariate regression analysis
      was performed to assess independent risk factors of ulnar non-union. Chi square test or
      Fisher exact test was used to compare categorical measurements. Statistical significance was
      considered as p less than 0.05.
    

Intervention name(s): Open reduction and internal fixation (ORIF)
Intervention type(s): Procedure
Intervention description(s): ORIF with a forearm plate
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Anatomical study: 14 upper extremities from the Department of Human Anatomy. Clinical
        study. Records about 211 ulnar fractures. We included only the fractures with the
        complication of ulnar nonunion.
Relapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or Placebo
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being carried out to see if quetiapine (Seroquel) is effective in preventing
      patients from a schizophrenic relapse when studied for a long time (1 year) and if so, how it
      compares with non-active treatment.
    


Intervention name(s): Seroquel (quetiapine)
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia
Effects of Low Concentration Atropine on Pupillary Size and Accommodative Amplitude
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the two-week ocular responses, especially on pupillary size and accommodative
      amplitude, of nightly application of 0.01% or 0.02% or 0.03% atropine eye drops in children
      with myopia who were randomized to use of three different low-concentration atropine eye
      drops
    

Detailed description: 
      Atropine was proven to be effective in controlling myopia progression. However, the most
      common side effects of the use of atropine eye drop are dilation of pupil and decrease of
      accommodation. The investigators wish to evaluate the ocular responses of three low
      concentration atropine eye drops, 0.01% or 0.02% or 0.03%, mainly on the pupillary size and
      accommodative responses in children aged between 6 to 12 years old over two-week usage.
    

Intervention name(s): 0.01% atropine eye drops; 0.02% atropine eye drops; 0.03% atropine eye drops
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.01% atropine sulphate; 0.02% atropine sulphate; 0.03% atropine sulphate
Intervention MeSH terms: Atropine; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: myopia control; low concentration atropine eye drops; anti-muscarinic receptors; pupil size; accommodative amplitude
DDI (Effect of Metformin and Furosemide on Rosuvastatin PK)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the relative bioavailability of
      rosuvastatin when given alone (Reference treatment, R) compared to when given together with
      one of the three different doses of metformin (10 mg, Test treatment 1 (T1); 50 mg (T2); 500
      mg (T3)) or one of the two doses of furosemide (1 mg (T4); 5 mg (T5)).
    


Intervention name(s): Rosuvastatin; Metformin HCl; Furosemide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Furosemide; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Attentional Focus Influence During Cranio-Cervical Flexion Test
Condition: Neck; Anomaly; Muscle Weakness; Muscle Weakness Condition
MeSH terms: Muscle Weakness; Paresis; Asthenia
Study type: Interventional

Summary: 
      The purpose of this study is to termine if a different attentional focus would alter the
      motor control in cervical muscles during the cranio-cervical test.
    

Detailed description: 
      Asymptomatic subjects will be recruited to this study. Superficial electromyography of the
      Sternocleidomastoid, Range of Motion (ROM) and Cranio-Cervical Flexion Test (CCFT) will be
      measured before, immediately after change in focus of attention, 2 days after training under
      a particular focus of attention, and 7 days after training the task under the same focus of
      attention.

      Subjects will be randomized into three groups: Internal focus of attention, external focus of
      attention and control group.
    

Intervention name(s): Internal Focus of Attention; External Focus of Attention; Control
Intervention type(s): Other; Other; Other
Intervention description(s): Information already included in arm/group descriptions.; Information already included in arm/group descriptions.; Information already included in arm/group descriptions.
Other intervention name(s): Internal Focus; External Focus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cranio-cervical; Motor Control; Deep Flexor muscles
Balance Analysis System Through Biaxial Rotation Force Platform
Condition: Balancing Interference
Study type: Interventional

Summary: 
      This study developed a system for studying an individual's postural balance in an upright
      position on a force platform with controlled movement of 2-axis rotation (transverse and
      anteroposterior), by analyzing lower limb muscle activation and data from Pressure Center of
      displacement.
    

Detailed description: 
      The use of rotating force platforms has proven to be an important resource in the study of
      postural balance and motor control. Platforms composed of two force plates allow the analysis
      of the load relationship between the feet and the study of the coordination of the lower body
      segments in postural control. Center of pressure displacement data during perturbations
      generated by platform rotation allow the study of dynamic postural balance. However, devices
      that meet these characteristics are not common and have limitations on amplitude or speed of
      rotation. Thus, a force platform composed of two plates was developed, capable of collecting
      data for the calculation of the parameters of the center of pressure, differentiating each
      foot, with a computerized system to control amplitude and speed of rotation in the
      mid-lateral and anteroposterior axes. A new version of embedded and supervisory systems that
      control the device, collect and process the created data has also been developed. For
      platform functionality tests, volunteers were divided into three groups of 15 individuals:
      Group 1 (G1): women aged 18 to 40 years; Group 2 (G2): women aged 40 to 60 years; Group 3
      (G3): women over 60 years old.
    

Intervention name(s): Force platform
Intervention type(s): Device
Intervention description(s): In order to volunteers to be selected for collection a recruitment test will be taken, the volunteer will have to stand on one foot for 5 seconds without additional support. So that the volunteer can go to the balance test on the force platform, he will be dressed with safety equipment (harness), and will also have the attachment of the electrodes.
Intervention model: Single Group Assignment
Intervention model description: Biaxial rotation force platform combined with electromyography
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Center of pressure; Dynamic postural balance; Force platform; Posturography; Electromyography
Responses to Influenza Vaccine in Patients With Mitochondrial Disorders (MELAS)
Condition: MELAS Syndrome
MeSH terms: MELAS Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This pilot clinical study evaluated the safety and metabolic responses to a licensed
      inactivated seasonal influenza vaccine (TIV) in mitochondrial encephalopathy, lactic
      acidosis, and stroke-like episodes syndrome (MELAS) volunteers and controls.
    

Detailed description: 
      This pilot clinical study evaluated the safety and metabolic responses to a licensed
      inactivated seasonal influenza vaccine (TIV). This study will consist of two cohorts: MELAS
      syndrome volunteers (a specific identified disorder of mitochondrial dysfunction:
      mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes) between 13-60 years
      OR adult control volunteers between 18-65 years of age. Both cohorts will receive the same
      treatment: a single vaccination with an FDA-licensed intramuscular seasonal trivalent
      inactivated influenza vaccine (TIV).

      All participants will receive a single administration of a licensed influenza vaccine. Prior
      to vaccination, participants will provide information regarding health history and responses
      to health questionnaires. A blood sample and urine specimen were collected prior to
      vaccination, and at 6 hours, 5-7 days and 26-30 days post-immunization.
    

Intervention name(s): Fluzone®
Intervention type(s): Biological
Intervention description(s): This vaccine is given intramuscularly, either the 2010-2011 or 2011-2012 vaccination was given as appropriate
Other intervention name(s): trivalent inactivated influenza vaccine (TIV); FDA-licensed seasonal influenza vaccine
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Mitochondrial disorder; Trivalent inactivated influenza vaccine; Adolescents and adults; Immune response; Metabolic response
Liposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of combining liposomal doxorubicin with
      ifosfamide in treating patients who have advanced or metastatic soft tissue sarcoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of ifosfamide in combination with doxorubicin HCl
           liposome in patients with previously untreated advanced or metastatic soft tissue
           sarcoma.

        -  Determine the objective response in patients treated with this regimen.

        -  Determine the dose-limiting toxicity in patients treated with this regimen.

      OUTLINE: This is a multicenter, dose-escalation study of ifosfamide.

      Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and ifosfamide IV over 4
      hours on days 1-3 OR on days 1-4 (for patients enrolled on dose level 6). Treatment repeats
      every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable
      toxicity.

      Cohorts of 3-6 patients receive escalating doses of ifosfamide until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
      of 3 or 2 of 6 patients experience dose-limiting toxicity.

      Patients are followed every 8 weeks until disease progression and then every 12 weeks
      thereafter.

      PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.
    

Intervention name(s): ifosfamide; pegylated liposomal doxorubicin hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Ifosfamide
Primary purpose: Treatment
Keywords: adult angiosarcoma; adult fibrosarcoma; adult leiomyosarcoma; adult liposarcoma; adult neurofibrosarcoma; adult synovial sarcoma; stage III adult soft tissue sarcoma; adult alveolar soft-part sarcoma; adult epithelioid sarcoma; adult malignant fibrous histiocytoma; adult malignant hemangiopericytoma; adult malignant mesenchymoma; adult rhabdomyosarcoma; stage IV adult soft tissue sarcoma
Central Obesity and Disease Risk in Japanese Americans
Condition: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Hypertension; Obesity; Diabetes Mellitus, Non-insulin Dependent; Hyperinsulinism; Insulin Resistance; Coronary Arteriosclerosis; Diabetes Mellitus; Metabolic Syndrome X
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus; Obesity; Metabolic Syndrome; Insulin Resistance; Hyperinsulinism; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      To conduct a longitudinal study of central obesity and related risk factors found to be
      associated with hypertension and atherosclerotic cardiovascular disease (ASCVD) in a
      previously-examined cross-sectional cohort of second-generation Japanese Americans and in a
      newly-recruited cohort of third generation Japanese Americans.
    

Detailed description: 
      BACKGROUND:

      The study was conducted in response to a program announcment issued in 1991 on obesity and
      tests the hypothesis that atherosclerotic cardiovascular disease (ASCVD), hypertension,
      and/or non-insulin dependent diabetes mellitus (NIDDM) develop in Japanese Americans when
      there is a truncal pattern of weight gain (central adiposity), which is in turn accompanied
      by insulin resistance, hyperinsulinemia, and lipid abnormalities. This cluster of
      abnormalities has been called 'Syndrome X'. It is postulated that 'Syndrome X' develops in
      Japanese Americans in response to environmental (behavioral) factors, many of which reflect
      'westernization' in this ethnic group. The research plan focuses upon the relationship
      between central obesity and metabolic changes and disease outcomes associated with 'Syndrome
      X' along with the behavioral variables that potential risk factors for the development of
      this cluster of abnormalities.

      DESIGN NARRATIVE:

      The cohort was re-examined for diabetes, hypertension, coronary heart, disease, peripheral
      vascular disease, and a number of potential coronary heart disease risk factors including
      medical history, health practice, social history, diet, glycosylated hemoglobin, insulin,
      proinsulin, c-peptide, glucose, anthrometric measurements, lipids, and computed tomography on
      the thorax, abdomen, and thigh.
Tranexamic Acid in Cyanotic Heart Defects
Condition: Postoperative Hemorrhage
MeSH terms: Hemorrhage; Postoperative Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The use of antifibrinolytic agents such as to reduce blood loss in congenital cardiac surgery
      has been described in many studies
    

Detailed description: 
      40 patients in each one of the three groups; In control group will receive normal saline,
      Intravenous Tranexamic acid group received 50 mg / kg intravenousely followed by of 1
      mg/kg/hr.for six hours. The topical Tranexamic acid group will have 50 mg / kg of tranexamic
      poured into the pericoredial cavity. in the first 24 hours we will measure the total blood
      loss and transfusion requirements. Complate blood picture and coagulation studies will be
      recorded. the occurrence of re-exploration for excess bleeding, or adverse events.
    

Intervention name(s): Normal saline at induction; Normal saline infusion; Intravenous tranexamic acid; infusion tranexamic acid; topical tranexamic acid; topical normal saline
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.5 ml/kg; 1ml/kg/hr. during surgery for six hours; 50 mg/kg; 1mg/kg/hr infusionfor 6 hours; 50 mg/kg added to the normal saline 2 ml/kg into the pericardial cavity before sternal closure; 2 ml/kg into the pericardial cavity before sternal closure
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pediatric; Cyanotic heart disease; Tranexamic acid; Postoperative blood loss