bioihbjkbjnl/mcl2 huggingface dataset:
Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)
Condition: Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, randomized, placebo-controlled, double blind safety and efficacy
      clinical trial.
    

Detailed description: 
      To assess the safety and efficacy of Adipose-Derived Regenerative Cells (ADRCs) delivered via
      an intramyocardial route in the treatment of chronic ischemic heart disease in patients who
      are not eligible for percutaneous or surgical revascularization.
    

Intervention name(s): Celution System; Placebo
Intervention type(s): Device; Device
Intervention description(s): ADRCs processed by the Celution System for reintroduction into the myocardium; Physiological solution made of Lactated Ringers solution and a small amount (<1mL) of autologous blood
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ischemic heart disease; Coronary artery disease; Chronic Heart Failure; Cardiovascular disease; adult stem cells; adipose derived regenerative cells
Drug Resistance Inhibition in Treating Women With Recurrent or Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Some tumors become resistant to chemotherapy drugs. Combining PSC 833 with a
      chemotherapy drug may reduce resistance to the drug, and allow the tumor cells to be killed.

      PURPOSE: Phase II trial to study the effectiveness of PSC 883 and paclitaxel in treating
      women who have recurrent or metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the antitumor activity, as measured by frequency of objective
      response and time to progression, of the multidrug resistance modulator PSC 833 in
      combination with paclitaxel in women with recurrent or metastatic breast cancer. II. Describe
      the toxicity of this regimen.

      OUTLINE: All patients receive PSC 833 by mouth every 6 hours for a total of 12 doses.
      Paclitaxel is infused over 3 hours, after the 5th dose of PSC 833. Treatment is repeated
      every 3 weeks in stable and responding patients. PSC 833 must not be mixed with grapefruit
      juice. Growth factors may be used at the discretion of the investigator. Patients are
      followed every 3 months for the first two years, then every 6 months for years 2-5, and then
      annually thereafter.

      PROJECTED ACCRUAL: It is anticipated that approximately 36 patients will be entered over 24
      months if there are at least 6 responses in the first 17 patients.
    

Intervention name(s): paclitaxel; valspodar
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paclitaxel
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer
Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection
Condition: Herpes Simplex
MeSH terms: Infections; Herpes Simplex
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the acceptability and safety of famciclovir in infants with herpes
      simplex infection
    


Intervention name(s): famciclovir
Intervention type(s): Drug
Intervention description(s): Administered orally as a single individualized dose between 25-200 mg based on body weight.
Other intervention name(s): Famvir
Intervention MeSH terms: Famciclovir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infants, Herpes simplex infection
Salmonella Conjugates CVD 1000: Study of Responses to Vaccination With Trivalent Invasive Salmonella Disease Vaccine
Condition: Risk Reduction
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled dose-escalation study. The main purpose of this
      research is to test the safety and measure the immune response of the trivalent vaccine
      against invasive Salmonella disease. The vaccine will be tested over a range of doses.
    


Intervention name(s): Trivalent Invasive Salmonella Disease Vaccine (6.25 µg); Trivalent Invasive Salmonella Disease Vaccine (12 µg); Trivalent Invasive Salmonella Disease Vaccine (25 µg); Trivalent Invasive Salmonella Disease Vaccine (highest, well-tolerated dose among Cohorts A-C); Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Other
Intervention description(s): 6.25 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1.; 12 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1.; 25 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1.; The highest, well-tolerated dose of the conjugate vaccine among Cohorts A-C is administered via one or two intramuscular injection(s) into the deltoid muscle on Study Day 1 (and 29 if two doses are given).; 0.5 mL of buffer and preservative is administered via one or two intramuscular injections(s) into the deltoid muscle on Study Day 1 (and 29 if two doses are given).
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Lower Limb Performance, Balance and Coordination Differences Between the Muay Thai Athletes and Recreational Bodybuilders
Condition: Martial Arts; Body Building; Functional Performance
Study type: Interventional

Summary: 
      Purpose: The aim of this study was to compare balance, coordination and lower extremity
      functional performances of Muay Thai (MT) athletes and bodybuilders (BB).

      Method: Seventeen athletes (14 men and 3 women; mean age: 20.65 + 2.34) engaged in MT and 18
      (13 men and 5 women, mean age: 25.89 + 4.83) engaged in BB were included in the study. The
      Flamingo Balance Test and Y Balance Test were used to evaluate static and dynamic balance,
      respectively. Coordination was assessed using the Hexagon Test. Lower extremity functional
      performance was evaluated using the Single Leg Hop Test.
    


Intervention name(s): Exercise
Intervention type(s): Procedure
Intervention description(s): Nine different clubs and sport centers were screened and 18- to 35-year-old individuals regularly engaged in MT or BB for the last 6 months were invited to join the study.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 35 participants, 17 athletes (14 men and 3 women) engaged in MT and 18 athletes (13 men and 5 women) engaged in BB were included in the study
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Muay Thai; Body Building; Balance; Coordination; Lower Extremity Functional Performance
First rTMS for Treatment of Drug Induced Tardive Syndromes. Double Randomized Clinical Trial
Condition: Drug Induced Tardive Syndrome (DITS)
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      This study aims to evaluate the efficacy of rTMS on DITS. Twenty patients with DITS were
      recruited from the outpatient clinic of Aswan University Hospital. The patients were
      classified into two equal groups, 1st group received real high frequency rTMS at 100% RMT and
      the 2nd group received sham stimulation with the same pulse delivery but with the coil placed
      perpendicular to the scalp. For each patient 10 sessions were administered once per day for 5
      consecutive days each week for two weeks. All patients were assessed before rTMS and
      immediately after the end of the 10 sessions. This study is double blinded (the doctor and
      the patients). Assessment with AIMS scale and different parameters of cortical excitability
      were performed before and after the end of sessions treatment.
    

Detailed description: 
      The aim of this study was to evaluate the efficacy of repetitive transcranial magnetic
      stimulation (rTMS) on drug induced tardive syndromes.

      the effect of rTMS compare. Twenty patients with drug induced tardive syndromes were
      recruited from the outpatient clinic of Aswan University Hospital. The patients were
      classified into two equal groups, 1st group received real 20 Hz-rTMS at 100% RMT (a total of
      2000 pulses to each hand area consisting of 10 trains of 200 pulses with intertrain interval
      30 s), and the 2nd group received sham stimulation with the same pulse delivery as the 1st
      group but with the coil placed perpendicular to the scalp. For each patient 10 sessions were
      administered once per day for 5 consecutive days each week for two weeks. All patients were
      assessed before rTMS and immediately after the end of the 10 sessions. The patients did not
      know which type of stimulation they received and to ensure that, the study was double blinded
      the doctor who assessed the patients didn't know which type of stimulation the patients
      received. None of the patients had had rTMS before and were unaware of the type of
      stimulation.The AIMS scale and different parameters of cortical excitability were assessed
      before and after the end of session treatment.
    

Intervention name(s): Repetitive transcranial magnetic stimulation (rTMS)
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rTMS, Drug Induced Tardive Syndrome
Outcome of Proximal Humerus Fractures :Anatomic Neck Fractures vs Surgical Neck Fractures
Condition: Humeral Fracture, Proximal; Internal Fixation; Complications, Mechanical, Bones of Limb
MeSH terms: Fractures, Bone; Humeral Fractures; Shoulder Fractures
Study type: Observational

Summary: 
      From April ,2014 to April 2015,31 patients with fractures of the proximal humerus were
      treated in our hospital. According to anatomic neck fractures (ANF) and surgical neck
      fractures (SNF), we divided the patients into two groups. All the patients were followed at
      least 1 year.
    


Intervention name(s): Locking plates were used for proximal humeral fractures.
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        From May ,2013 to April 2015, patients with fractures of the proximal humerus who were
        treated with locking plate.
Comparison of the Centric Relation Recorded by Two Methods Using Cone Beam Computed Tomography
Condition: Tooth Loss
MeSH terms: Tooth Loss
Study type: Interventional

Summary: 
      The purpose of this study was to investigate and compare the variation in mandibular relation
      recorded by the gothic arch methods and the K7 method using cone beam computed tomography
      (CBCT)
    

Detailed description: 
      ten asymptomatic participants were selected,the centric relation registrations were
      separately recorded according to the technique of the gothic arch method and the
      neuromuscular method,subsequent, they were instructed to perform CBCT wearing two bite
      registrations,thus using dophin software to calculate the tmj space and the upper airway and
      using exocad software to ananyse the mandibular position, Data were analysed with paired
      t-test
    

Intervention name(s): the centric relation
Intervention type(s): Procedure
Intervention description(s): All participants were recorded the centric relation registrations according to the technique of the gothic tracing method and the neuromuscular method separately.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cone-Beam computed tomography; the centric relation; the upper airway; mandibular position
Diabetes and Metabolic Postprandial Responses
Condition: Type 2 Diabetes; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The aim of this trial was to compare postprandial metabolic response to glucose load in
      healthy overweight and type 2 diabetic subjects, by using glycemia, insulinemia, lipid
      profile, nutrient oxidation follow-up. Stable isotopes of glucose were used to assess
      postprandial total,exogenous and endogenous glucose kinetics.
    


Intervention name(s): oral glucose load
Intervention type(s): Other
Intervention description(s): oral ingestion of 13C labeled glucose
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: type 2 diabetic subjects
Rehabilitation Glasses for the Treatment of Hemispatial Neglect
Condition: Hemispatial Neglect
MeSH terms: Perceptual Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This project is designed to test a lightweight, portable, computerized pair of glasses that
      will help reduce some of the cognitive deficits seen in patients who have suffered damage to
      their right cerebral hemisphere.
    

Detailed description: 
      Hemispatial neglect is the inability or failure to attend and respond to the left side of
      space. Patients suffering right cerebral hemispheric damage from stroke or traumatic brain
      injury frequently suffer neglect and will ignore all information located in the left side of
      space. Currently there is no effective rehabilitation technique to treat neglect and many of
      these patients have severe long-term disability. The goal of this project is to determine
      whether a prototypical pair of rehabilitation glasses can reduce the symptoms of hemispatial
      neglect.
    

Intervention name(s): Computer rehabilitation glasses
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1/2 patients receive visual stimulation with rehabilitation glasses. 1/2 patients receive control stimulation with rehabilitation glasses.
Masking: Single (Participant)
Primary purpose: Treatment
Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy
Condition: Stage III Esophageal Squamous Cell Carcinoma; Stage II Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      Megestrol is a semisynthetic progesterone derivatives, have promote anabolic effects. Can
      improve appetite, weight gain, and improve bone marrow suppression, increase the tolerance
      put, chemotherapy, improve the quality of life, is widely used in tumor radiation and
      chemotherapy of terminally ill patients. But because of its vascular embolization, vaginal
      bleeding, arrhythmia and other serious complications, there is no unified standard.

      The purpose of this study was to evaluate megestrol in esophageal squamous carcinoma radical
      chemoradiation curative effect and side effects, for rational use in the process of radiation
      and chemotherapy megestrol provide guidelines. A total of 210 patients will be accrued from
      China.The primary end point is quality of life (will be evaluated by EORTC QLQ-C30); the
      secondary end point is the pathological response after treatment and adverse events.
    

Detailed description: 
      The investigators plan to recruit the patients who were pathologically confirmed with
      esophageal squamous cell carcinoma and performed chemoradiotherapy from the Oct 2014. The
      patients will be divided into two groups.Experimental group：esophageal cancer patients with
      oral megestrol chemoradiation. Megestrol（Yining）：160mg/d，po,5 weeks in total，oen week before
      chemoradiotherapy and one week after chemoradiotherapy.

      chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w.Control group:
      Esophageal cancer patients with chemoradiation without oral
      megestrol.chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w.The
      primary end point is quality of life (will be evaluated by EORTC QLQ-C30); the secondary end
      point is the pathological response after treatment and adverse events.
    

Intervention name(s): Megestrol（Yining）; radiotherapy; chemotherapy
Intervention type(s): Drug; Radiation; Other
Intervention description(s): Megestrol（Yining）: 160mg/d, po,7 weeks in total, one week before chemoradiotherapy and one week after chemoradiotherapy.; radiotherapy (radiation): 50Gy in total，2 Gy/d，5d/w.; capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total or capecitabine(Aibin) plus Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V. or cisplatin: 75mg/m2 d1，29 5-Fu：750mg/m2CIV24h d1-4，d29-32. The 3 regimens were Randomly distributed to patients.
Other intervention name(s): Yining; radiation
Intervention MeSH terms: Megestrol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chemoradiotherapy; Esophageal Squamous Cancer; Megestrol
Study of Hand Therapy 3 to 24 Months After Stroke
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The primary aim of this study is to investigate the effectiveness of the use of a robotic
      hand therapy device in the home environment. We hypothesize that the therapy group will
      improve hand function more than a customary and usual care group.
    

Detailed description: 
      Many stroke survivors have significant limitations of upper extremity function which impacts
      many important activities such as eating, dressing and personal care. Studies show that to be
      effective in increasing functional independence, therapy must involve active participation of
      the patient and repetitive training. Robotic therapy offers a means of transferring some of
      this essential, but time consuming, therapy into the home. Seventy subjects (3 to 12 months
      post stroke)are being randomized to a control group that utilizes an innovative robotic hand
      therapy device in the home for three months or a control group that receives no device
      treatment. Clinical motor function and quality of life measures will compare the groups
      before intervention, immediately after, and 3 months later. The control group will receive
      device treatment for 3 months following their final evaluation. The results will provide
      valuable data on the ability of monitored home therapy to provide effective treatment. This
      project has the potential to increase the availability of effective rehabilitation techniques
      to patients with stroke.
    

Intervention name(s): Hand Mentor
Intervention type(s): Device
Intervention description(s): Use of the Hand Mentor therapy device at home for 6 weeks. Therapy programs include spasticity reduction, motor control, and emg biofeedback for encouraging activity.
Other intervention name(s): Hand Mentor Home
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke rehabilitation; stroke therapy; hand therapy; stroke; cerebrovascular stroke; cerebral stroke
The ATLANTA First in Man Study of the Catania Stent
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the short-term and mid-term safety and efficacy of the Catania coronary stent for
      the treatment of up to two de novo lesions in native coronary arteries.
    

Detailed description: 
      This is a prospective, non-randomized, first-in-man single center study. The study requires a
      55 patients with documented myocardial ischemia undergoing PCI.
    

Intervention name(s): PCI
Intervention type(s): Device
Intervention description(s): coronary stent implantation
Other intervention name(s): Catania Stent
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary Stent
Cardiovascular Risk Factors in Overweight Adolescents
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The aim of the present study was to determine the effects of either a multidisciplinary
      approach or intensity-controlled interval training on cardiovascular risk factors in
      overweight adolescents.
    

Detailed description: 
      Several approaches have been used to improve cardiovascular health status and quality of life
      in obese children and adolescents, without coming to a consensus decision. Recently, a few
      studies have determined the effects of exercise training and diet on endothelial function in
      overweight and obese children and adolescents. The main findings are that only a moderate
      amount of exercise training and diet changes improves or restores endothelial function. It is
      difficult, however, to asses the separate effects of the training and diet, particularly
      because none of the studies have used a homogenous exercise training regimen. Unanimously,
      better, but affordable prevention and treatment strategies to improve wide-scale health
      outcome are called upon to slow down the current epidemic of overweight. It is now well
      established that physical activity reduces, but does not currently prevent the epidemic of
      obesity from either reaching global proportions or taxing public health and economy. Despite
      the recent advances in understanding the responsible biology of improved cardiovascular
      health with exercise training, several lines of research questions are still unresolved. For
      instance, the optimal program, e.g. when to initiate, whom to prescribe exercise to, which
      exercise-intensity is required, and the actual design of the treatment program, remain by far
      yet to determine.
    

Intervention name(s): Multitreatment approach; Aerobic interval training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 months regimen consisting of group meetings every 2 weeks involving a physician, psychologist, physiotherapist and clinical nutritional physiologist. 21 h treatment during the first 3 months: 3 activity sessions (3 h) and 3 group conversations (4 h). Attendance inclusion criterium was set to minimum of 80%; Walking/running 'uphill' on a treadmill twice a week for 3 months. 10 min warming-up at 70% of Hfmax before performing 4x4 intervals at 90-95% of Hfmax. 3 min active recovery at 70% of Hfmax between each interval. 5 min cool-down period, giving a total of 40 min.
Other intervention name(s): multidisciplinary approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise Training; Cardiovascular diseases; Risk factors