cyrilzakka/clinical-trials huggingface dataset:
Impact of Propofol Reduction in Anesthesia Induction

Objective: Determine if, by reducing the dose of propofol and increasing the time elapsed between fentanyl and propofol administration, hemodynamic response is improved.

Methods: Patients were randomized into time groups (2 and 1 minute) and each subdivided into dose groups (1, 1.5 and 2 mg kg-1) obtaining six time-dose groups. After receiving 2 μg kg-1 of fentanyl, propofol was administered after the predetermined time. Time to hypnosis (BIS\<60) and hemodynamic parameters at pre-induction, pre-intubation and postintubation were registered.

A minimum of 162 patients were required, considering an expected Mean Difference of 5 with expected Standard Deviation of 22, confidence level of 95% and power of 80%. Estimating a possible loss of 15%, it was raised to 192. Consecutive identification numbers were assigned and the sample was randomized in six groups of 32 patients according to time and dose of propofol.

Pre-oxygenation was performed until the expired oxygen fraction exceeded 80% and 2 µg/kg of intravenous fentanyl were administered. Depending on the study group, 1 or 2 minutes were allowed to pass and 1, 1.5 or 2 mg/kg of propofol were supplied (prior administration of intravenous lidocaine 0.5 mg/kg). The time in which the BIS dropped below 60 was recorded. If it did not reach that level after two minutes or when it exceeded it but then rose above 60 again, an extra dose of propofol of 0.5 mg/kg was administered. Muscle relaxation was performed with rocuronium 0.6 mg/kg. The patient was manually ventilated until endotracheal intubation was performed by the same experienced anaesthesiologist and connected to mechanical ventilation.

Data were collected manually. Statistical analysis was performed using SPSS ver. 22. Inferential statistics were performed using t-test for quantitative variables, chi-square for qualitative and ANOVA for qualitative and quantitative comparisons. Non-parametric statistical tests were used when necessary. Confidence intervals were estimated at a level of 95% and a P value of \<.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Adults who required general anesthesia
* General anesthesia with endotracheal intubation (no supraglottic devices)
* Signed informed consent
* Non-cardiac surgery
* Same anesthesiologist

Exclusion Criteria:

* Hemodynamic instability (systolic BP \< 90 mmHg with clinical signs of low cardiac output: impaired consciousness, diuresis \<0.5 ml/kg/h, central venous saturation \<60% with normal arterial saturation or lactate \>3 mmol/l)
* Increased risk of bronchoaspiration (absence of fasting, stomach retention, intestinal obstruction, pregnancy, etc.)
* Suspected difficult airway
* Known allergy to anesthetic drugs
Effectiveness of Percutaneous Neuromodulation in the Treatment of Cervical Pain in University Students.

A non-randomized experimental study will be conducted to investigate the effect of Ecoguided Percutaneous Neuromodulation on patients with and without neck pain in college students. The sample will be collected in a non-probabilistic way at convenience among the students at the San Pablo-CEU University, with a sample that will be divided into two groups: group 1 (G1) with neck pain and group 2 (G2).


Eligibility Criteria:
Inclusion Criteria:

* Current Cervical Pain on a Visual Analog Scale (VAS) greater than 3.
* Neck pain in the last 12 weeks, and no treatment has been performed.
* Disability index of 8% or more on the Neck Disability Index.
* That they have undergone treatment.

Exclusion Criteria:

* Neck pain associated with vertigo.
* Osteoporosis (control X-ray).
* Diagnosed psychological disorders.
* Vertebral fractures (control X-ray).
* Tumors.
* Diagnosed metabolic diseases.
* Neck surgery.
* Belonephobia.
Type 2 Diabetes Affect Exercise Induced Improvement in Insulin Sensitivity

This study investigates weather a family history of type 2 diabetes affects exercise induced improvements in insulin sensitivity in the hispanic population

A family history of T2D (FH+) is a risk factor for developing insulin resistance (which precedes T2D) and T2D (Ryder et al., 2003). Exercise training on the other hand has been shown to improve insulin sensitivity and is highly effective to prevent/manage T2D. However it is not known if early signs of insulin resistance appear before being clinically diagnosed and if the benefits of exercise which prevent/cure T2D, are limited to the offspring of Hispanic T2D parents. Therefore, the proposed study will determine 1) if normoglycemic (normal blood glucose) offspring of T2D parents are insulin resistant, using the gold standard method to measure insulin sensitivity and metabolic flexibility (ability to switch between carbohydrate and fat oxidation) 2) if 8 weeks of exercise training improves insulin sensitivity and metabolic flexibility to the same extent in FH+ compared to normoglycemic offspring of parents without any history of T2D (FH-) and 3) if 8 weeks of exercise training will change the blood, lipid and molecular profiles relevant to insulin sensitivity to same extent in FH+ compared to offspring of parents without family history of T2D (FH-).

Eligibility Criteria:
Inclusion Criteria:

* 18 ≤ Age ≤ 40 years
* 18 ≤ BMI ≤ 30 kg/m2
* Both parents are Mexican/Mexican-American)
* Sedentary lifestyle
* Less than 60 minutes/wk. of structured exercise
* Physical activity level ≤ 1.4

Exclusion Criteria:

* Evidence of significant cardiovascular disease or diabetes
* A fasting blood glucose ≥100 mg/dL
* Screening blood pressure \>140/90
* Hyperlipidemia
* Use of drugs affecting energy metabolism or body weight
* Excess alcohol, drug abuse, and smoking
* Eating disorder or eating attitudes interfering with study
* Unwillingness to be abide by randomization
Autologous Cell Therapy After Stroke

This study will examine the safety of two different cellular therapies in the treatment of stroke.

Stroke remains a leading cause of death and disability. A limited number of therapies, such as intravenous tissue plasminogen activator, have been approved to interrupt stroke in the early hours after symptom onset. Many patients are not able to benefit from these therapies, however, and so a need exists for development of new interventions to reduce disability after stroke. This study will be an early step towards this, and will examine the safety of two cell types, mononuclear cells and marrow stromal cells. In each case, the cells will be autologous, specifically being derived from the subject's own bone marrow.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke that is supratentorial in location and \< 72 hours old between stroke onset and bone marrow aspiration
* No major pre-stroke disability
* NIH stroke scale score of 7-24
* Able to undergo bedside bone marrow aspiration
* Age 18-85 years, inclusive
* Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy

Exclusion Criteria:

* No major active hematological, immunological, or oncological diagnoses
* Pregnancy
* Lactating mothers
* At least 24 hours time of any thrombolytic therapy and time of bone marrow aspiration
* Allergy to penicillin or to fetal bovine serum
* Active, major co-existent neurological or psychiatric disease
* Infection with HIV, hepatitis B or C, or syphilis
* Any diagnosis that makes survival to 90 days post-stroke unlikely
* Participation in an experimental therapeutic clinical trial in the prior three months
CRT RENEWAL Registry

This registry will provide detailed patient demographics and characteristics at the time of enrollment and will also provide data regarding predictors of clinical outcomes such as heart failure decompensation, heart failure hospitalization, NYHA class, and quality of life.

The CRT RENEWAL Registry aims to characterize patient demographics and clinical attributes at enrollment and overall event rates as defined by heart failure decompensation, heart failure hospitalization, death, and ventricular arrhythmic events. The registry will also assess clinical outcomes including quality of life (QOL), physical activity habits, and events rates, along with device diagnostics such as Activity Log Index and heart rate

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet current indications for the CONTAK RENEWAL® family of CRT-P or CRT-D devices
* Patients who receive either transvenous Guidant manufactured ventricular leads or non-Guidant epicardial leads
* Patients who have had an ejection fraction measured within six months of enrollment
* Patients who sign and date a Patient Informed Consent form at the enrollment visit
* Patients who remain in the clinical care of the enrolling physician in approved centers

Exclusion Criteria:

* Patients who are expected to receive a heart transplant during the duration of the registry
* Patients who currently have or who are likely to receive a tricuspid valve prosthesis
* Patients who are currently enrolled in another observational registry or investigational study that would directly impact the treatment or outcome of the CRT RENEWAL Registry. Each instance will be brought to the attention of Guidant's Clinical Application Research Studies (CARS) Department to determine eligibility
* Patients who are younger than 18 years of age
* Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the registry
* Patients who are pregnant
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis

Study aiming at determining the efficacy of eccentric versus concentric exercises for improving tendon biological characteristics, pain, and shoulder overall function for rotator cuff tendinopathy in patients with Rheumatoid arthritis (RA).

Moreover, investigation the relationship between RA activity and the severity of rotator cuff tendinopathy.

Patients will be randomly assigned into either concentric or eccentric exercise group. Randomizations will be done using computer random generated numbers.

Study aiming at determining the efficacy of eccentric versus concentric exercises for improving tendon biological characteristics, pain, and shoulder overall function for rotator cuff tendinopathy in patients with RA. Moreover, investigation the relationship between RA activity and the severity of rotator cuff tendinopathy.

Patients will be randomizations using computer random generated numbers. patients will receive either eccentric or concentric exercises for internal, external rotators and abductors muscles All patient will do stretching for posterior capsule and pectoralis minor Tendon biological changes and subacromial space will be assessed using musculoskeletal ultrasonography Shoulder function will be assessed using SPADI (shoulder pain and disability index Pain will be assessed using Visual Analogue Scale (VAS) Rheumatoid arthritis disease activity will be assessed using Disease Activity Score-28 for Rheumatoid Arthritis with erythrocyte sedimentation rate (DAS 28 ESR) patient will be assessed at base-line and after finishing of the study

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients diagnosed with RA according to 2010 (American College of Rheumatology)(ACR)/European League Against Rheumatism (EULAR) Classification Criteria for RA
2. Patients diagnosed with rotator cuff tendinopathy based on clinical and musculoskeletal Ultrasonography (MSUS) finding.
3. Patient complaining of shoulder pain for at least 3 months
4. Positive jobs test or hornblower sign or left off test
5. Age ranged from 18 to 50 years.

Exclusion Criteria:

1. Patient indicated for surgical repair of rotator cuff
2. Patient with previous shoulder surgery.
3. Patient with history of intra-articular shoulder fracture.
4. Patient with history of shoulder dislocation
5. Diabetes mellitus
Impact of Comprehensive Intervention on the Cardiometabolic Risk in Children With Central Obesity (IGENOI)Obesity

Central obesity, present in the metabolic syndrome (MS), is associated with increased risk of insulin resistance (RI). The aim of the project is to evaluate the protective effect of comprehensive intervention (Mediterranean diet + physical activity) in the development of RI in children with central obesity based on genetic and epigenetic markers.

Objectives: 1) Apply a comprehensive therapeutic nutrition intervention program for monitoring the Mediterranean Diet (DM) slightly hypocaloric along with increased physical activity in children with central obesity 7-16 years). 2) Measure the effectiveness of this program by assessing changes in body composition, lifestyle and biological and molecular parameters (genetic and epigenetic).

Methodology: test randomized, longitudinal, controlled, two-year intervention field comparing a sample of 120 subjects from 7 to 16 years with central obesity, the effect of two interventions: a) intensive on lifestyle with a reduced calorie DM , physical activity and behavioral therapy, b) non-intensive with healthy diet recommendations following the usual pediatric advice. At 2, 6, 12 and 24 months after follow up changes will be assessed: a) the HOMA index, body fat, and the cardiovascular risk factors, b) diet, sleep patterns, physical exercise using questionnaires and accelerometers (intervention group), and c) the quality of life. genetic and epigenetic markers will be evaluated by genotyping SNPs genes related to RI; and the analysis of: a) DNA methylation in genes related to insulin resistance, b) expression of microRNAs and target genes related to insulin resistance and c) measure the length of telomeres. The therapeutic program will consist of individual sessions and group workshops for the patient and the family.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent by the child, parent or guardian. 3. waist circumference above the 90th percentile 4. Motivation and willingness to be assigned to either group, and do their utmost to follow protocol assigned.

5. Possibility of involvement in days of intensive phase (week 0, 1, 2, 3, 4, 5, 6, 7 and 8) and once a month until 6 months later at 4 months and every 6 months during the second year.

Exclusion Criteria:

1. Pre-Diabetes
2. Presence of other diseases
3. Pharmacotherapy
4. Monitoring special diets
5. Food intolerance
6. Regular alcohol consumption
7. Drug
8. Psychiatric illness or eating disorder
9. People without telephone or Internet access
The Art of Waiting: Evaluation of an Interactive Media Experience in a Children's Hospital Clinic Waiting Space

The purpose of this study is to test the hypothesis that providing low-intensity opportunities for interactive play can improve the waiting and overall clinic experiences of children. This study evaluates an innovative, interactive system called ScreenPlay designed to realize the intentions of the "Healing Environment" in the waiting space of a paediatric hospital.

Existing entertainment and distraction options (e.g. toys, video games) meet neither organizational standards nor families' needs with respect to accessibility and infection control. Additionally, they do not provide the types of positive experiences (e.g. calm, low intensity) that are most desirable for children awaiting treatment.

The goal of this research is to empirically evaluate the effectiveness of ScreenPlay, a technology that enables users to create or manipulate animations on a screen/projection, and to provide an evidence-informed model for the design of optimal paediatric waiting spaces. A blinded, clustered, parallel randomized controlled trial applying objective outcome measures and qualitative methods will be used to compare children allocated to one of three waiting conditions at a large urban rehabilitation hospital: (a) no media (standard care), (b) passive media (a silent nature video), or (c) interactive media (ScreenPlay). This study will answer the questions:

Can Interactive Media (i.e. ScreenPlay):

1. reduce state anxiety in children/youth attending an outpatient clinic? and,
2. improve child, parent, and staff satisfaction with the clinic experience?

We hypothesize that:

1. Decreases in state anxiety will be greater for children exposed to ScreenPlay for 10 minutes than for those exposed to passive (i.e. a nature video) or no media (i.e. standard care/control). The decrease in state anxiety associated with ScreenPlay will be \>5 points on the normalized 100 point State Anxiety Scale.
2. ScreenPlay will generate more movement/activity on the floor (i.e. an indicator of active engagement with the system) than the passive media or control conditions as measured via contact floor sensors.
3. The waiting and overall clinic experience of children with diverse mobility, parents, and staff will be perceived more positively when exposed to ScreenPlay as compared to passive media or control conditions.

Eligibility Criteria:
Participants include clients, their parents/guardians, and staff associated with the outpatient clinic at Holland Bloorview Kids Rehabilitation Hospital.

1. Children and youth aged 5 to 19 years and their guardian/parent.
2. Anticipated wait time ≥30 minutes to allow time to complete the study.
3. Ability to communicate in English through speech, writing/typing, or other communication device. Note: For children who cannot communicate their thoughts/feelings, parent-proxy may be used.
4. All outpatient clinic staff
Bioequivalency Study of Zidovudine Under Fasting Conditions

The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory findings during screening.

Exclusion Criteria:

* Allergic or adverse responses to zidovudine or any other comparable or similar products.
* Participation in clinical trial within 30 days of study initiation.
* Positive blood screen for HIV, Hepatitis B and C.
Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer

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 II trial to study the effectiveness of combination chemotherapy in treating patients who have recurrent or refractory small cell lung cancer.

OBJECTIVES: I. Determine the overall, complete, and partial response rates of patients with recurrent or refractory small cell lung cancer when treated with gemcitabine plus irinotecan. II. Determine the overall and failure free survival of these patients when treated with this regimen. III. Determine the duration of response of these patients after this treatment. IV. Evaluate the toxicity associated with the administration of this treatment in this patient population.

OUTLINE: Patients are stratified according to prior response duration (progression 90 days or more after initial therapy vs progression less than 90 days after initial therapy or no response to initial therapy). Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months for 2 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study over 12-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent or refractory small cell lung cancer Measurable disease At least 20 mm with conventional techniques OR At least 10 mm with spiral CT scan The following are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Tumor lesions situated in a previously irradiated area Known CNS metastases allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CTC 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No prior or concurrent malignancy in past 5 years except curatively treated carcinoma in situ of the cervix, breast, or basal cell or squamous cell carcinoma of the skin

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 prior chemotherapy or chemoradiotherapy regimen No prior gemcitabine or irinotecan Endocrine therapy: Not specified Radiotherapy: No more than 1 prior chemoradiotherapy regimen At least 2 weeks since prior cranial radiotherapy for CNS metastases No concurrent cranial radiotherapy Surgery: Not specified
Assist-Knee: Energy-Harvesting Knee Prosthesis

The purpose of this research is to validate the Assist-Knee design and function by collecting pilot data during the stand-to-sit-to-stand transition in transfemoral prosthesis users when using the Assist-Knee to harvest energy and return energy .


Eligibility Criteria:
Inclusion Criteria:

* Unilateral transfemoral limb loss
* At least one year post-amputation and currently successfully using a prosthesis
* Uses modular endoskeletal prosthetic components
* Has bilateral normal range of motion
* Ability to perform the following activities:
* Walking ability or ability to take steps over 10 meters
* Upright standing stability
* Stand-to-sit stability (i.e. go from a standing position to a seated position independently)
* Sit-to-stand stability (i.e. rise from a seated position independently)
* Ability to communicate individual perceptions in the English language
* Ability to provide informed consent

Exclusion Criteria:

* Confounding injury or musculoskeletal problem
* Pregnancy
* Lower limb peripheral neuropathy
* Symptomatic cardiovascular disease or chronic obstructive pulmonary disease
* Not able to read and understand English
* Use of assistive devices for sit-to-stand and stand-to-sit (e.g. canes, walkers)
Efficacy of Co-Spinal Ondansetron In Inguinal Herniorrhaphy

Ondansetron, a selective serotonin 5-HT3 receptor antagonist, is well known for its antiemetic effects. However, its ability to reduce hypotension during spinal anesthesia has recently sparked great interest. In clinical practice, administering ondansetron before spinal anesthesia has produced promising results.

This prospective randomized double-blinded controlled study will be conducted on 46 patients undergoing inguinal herniorrhaphy at Suez Canal University Hospital and will be randomly assigned to one of the two groups using a table of random numbers. Group A (23 patients) will be administered 8 mg of ondansetron diluted in 100 ml of normal saline, starting with the skin preparation for spinal anesthesia through the intravenous axis to be finished in 10 minutes. Group B (23 patients) will be administered 100 ml of normal saline, starting with the skin preparation for spinal anesthesia through the intravenous axis, to be finished in 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for inguinal herniorrhaphy in Suez Canal University Hospitals
* Height: 150 to 180 cm.
* Body mass index (BMI): not more than 35 kg/m².
* Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients), ASA II (American Society of Anesthesiologists physical status Grade II) = (patients with mild systemic disease and no functional limitations).

Exclusion Criteria:

* Patients refused to participate in the study.
* Contraindications of spinal anesthesia.
* Known allergy to bupivacaine or ondansetron.
* Patients with a history of arrhythmia, especially those with prolonged QT intervals.