cyrilzakka/clinical-trials huggingface dataset:
Effect of Pre-injection of Lidocaine on Myoclonus Induced by Induction With Etomidate in Elderly Patients During General Anesthesia

To evaluate the effect of pre-injection of lidocaine on myoclonus induced by induction with etomidate during general anesthesia in elderly patients


Eligibility Criteria:
Inclusion Criteria:

* 1. Aged between 60 and 81 years 2. Body mass index: 20 to 30 kg/m2 3. American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ 4. Signed informed consent form

Exclusion Criteria:

* 1. Use of sedatives or opioids 2. History of central nervous system diseases, like epilepsy, shaking palsy, or chorea, etc 3. Hyperthyroidism 4. Serious diabetes 5. Hyperkalemia 6. Cardiac surgery 7. Serious ventricular disease or atrioventricular block 8. Liver or renal dysfunction 9. Allergies to amide local anesthetics or fat emulsion
A Systematic Investigation of Phonetic Complexity Effects on Articulatory Motor Performance in Progressive Dysarthria

The goal is to improve the fundamental knowledge about articulatory motor performance in people with Lou Gehrig's disease (also known as ALS) and Parkinson's disease (PD), in order to develop more sensitive assessments for progressive speech loss, which may lead to the improved timing of speech therapies.

The long-term goal is to optimize dysarthria assessment by improving the early detection and tracking of articulatory performance in progressive dysarthrias. The short-term goal of the proposed cross-sectional study is to focus on ALS and PD and quantify articulatory kinematic performance as a function of phonetic complexity, which is experimentally manipulated based on theoretical principles of speech motor development. The research strategy is to use 3D electromagnetic articulography to examine phonetic complexity effects of single word stimuli at the articulatory kinematic level in 15 talkers each with preclinical, mild, and moderate dysarthria, relative to 45 controls. The central hypothesis is that as dysarthria severity increases the discrepancy in articulatory performance, indexed by movement speed, distance, coordination, and variability, between people with dysarthria and typical controls will significantly increase at a lower phonetic complexity level.

Eligibility Criteria:
Inclusion Criteria:

1. May or may not have a neurological impairment.
2. Age range of 19-90 years.
3. Male or female.
4. Provide written consent before any study specific procedures are performed.
5. Have ability to comply with basic instructions.
6. Monolingual English speaker.
7. Have ability to partake in a 90 minute data collection.

Exclusion Criteria:

1. Any speech, language, cognition, or hearing impairment prior to diagnosis of a neurodegenerative disease.
2. Anyone not appropriate for study participation, as deemed by the principal investigator.
Non Invasive Detection of Cardiac Allograft Rejection by Circulating microRNAs

The purpose of this study is to evaluate the level of expression of 4 circulating microRNAs in the serum using RT-PCR. A pilote study with cardiac transplant patients has shown that expression of these microRNAs could discriminate patients with a histologically proven rejection from patient displaying a normal endomyocardial biopsy. The signature must be confirmed in unselected patients and its stability evaluated according to clinical, biological and immunological parameters of included patients.

Heart transplantation is the only available long-term treatment option for patients with terminal heart failure.

Despite considerable progress in immunosuppressive regimens, allograft rejection remains a major cause of graft loss.

Majority of cardiac allograft rejection are asymptomatic. Only severe rejection goes along with cardiac dysfunction. This clinical latency makes the cardiac rejection diagnostic difficult and has ruled modalities of detection of cardiac rejection.

The cornerstone of rejection diagnosis and post-transplant follow-up relies on endomyocardial biopsy (EMB) and classical histopathology assessment. Echocardiography and MRI are neither sensitive nor specific enough to replace EMB. Majority of transplant centers thus evaluate rejection using iterative protocol biopsies. These cardiac allograft monitoring protocols are heavy, with 15 to 20 EMB in the first year of transplantation and 1 to 2 EMB each year after the first year. EMB are invasive procedure with a low but not zero risk of severe adverse events. Repetition of EMB is associated with tricuspid regurgitation due to valvular complications. Moreover incidence of cardiac rejection explains the cost-effectiveness of EMBs: 50 to 70% of biopsies are normal.

The goal is thus to detect rejection in the blood by measuring expression levels of 4 circulating microRNAs in patients' sera by RT-PCR. The seric expression levels of these 4 circulating microRNAs will be compared to the histopathological diagnosis made on concomitant endomyocardial biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a cardiac transplant at the time of inclusion
* Patients transplanted for less than 10 years and having an annual follow-up
* Patients with a biopsy evaluation during their follow-up, at month 1, 3, 6, 12 (newly transplanted) and annually (newly and already transplanted patients) and concomitant routine blood work
* Patients not opposed to the study
* Patients with assessment of anti-donor specific antibodies during the study period

Exclusion Criteria:

* Patients with a multi-organ transplantation
Effects of Transverse Thoracic Mobilization With and Without Lower Trapezius Strengthening Exercises

Mechanical neck pain is a common musculoskeletal problem, worldwide. Patients with neck pain often have subjective complaints of muscle stiffness, tension, or tightness in addition to their pain located between the occiput and the third thoracic vertebra Approximately 68% of the total population has experienced neck pain at least once in their lifetime, and it easily transforms into a chronic state (that persists for more than 3 months). In today's society, this is conspicuous in many laborers due to the increased use of computers, where the neck and shoulders are maintained in static abnormal postures to look at the computer screens and become vulnerable to cause neck pain. The aim of the study is to determine the comparative effects of transverse thoracic mobilization with and without lower trapezius strengthening exercises on pain, disability and range of motion in patients with mechanical neck pain.

A Randomized controlled trial will be conducted in physiotherapy outpatient department of Syed Medical Complex and Islam Hospital, Sialkot. Non-probability consecutive sampling will be used to collect the data. Sample size of 20 subjects with age group between 18 to 40 years will be taken. Data will be collected by using tools Numeric Pain Rate Scale (NPRS) for pain, Neck Disability Index (NDI) for disability and Universal Goniometer (UG) for range of motion of neck. An informed consent will be taken. A total of 20 subjects will be selected by following inclusion and exclusion criteria and will equally divided in to two groups by random number generator table. Both groups will come thrice per week for a total of 4 weeks. The data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the age range of 18-40 years with mechanical neck pain for at least 3months.
* Examination- Symptoms provoked by neck movement and/or palpation of neck musculature.
* Trapezius Strength Test -To assess lower trapezius muscle strength, patient in prone with shoulder 120 degree abducted and resist the shoulder extension diagonally.

Exclusion Criteria:

* Osteoporosis
* Tumors
* Vertebral fractures
* Diagnosed psychological disorders
* Neck pain associated with vertigo
* History of cervical and thoracic spine injury
* Cervical radiculopathy
* Traumatic neck injury
* Shoulder surgery
Follow-up of Cell Changes in the Cervix

The purpose of the study is to follow up on cell changes detected in the cervical cancer screening program, to investigate whether they are handled with adequate quality.

The aim of the study is to clarify whether follow-up of cell changes is carried out with sufficiently good quality. It is nationally recommended to perform an HPV test on mild cell changes and only refer to clinical follow-up if you are HPV positive. Descriptive statistics on HPV-testing and follow-up of quality are not available today. If HPV testing has not already been performed, archived samples with glandular cell changes will be HPV-analyzed in Cobas 4800 HPV-polymerase chain reaction (PCR), which shows data on the presence of HPV and Luminex-PCR, which shows which HPV types the samples have. Women with low-grade squamous cell changes (ASCUS and CIN1) with simultaneous HPV analysis will be followed up with data from the Swedish National Cervical Screening Registry (NKCx) from the last ten years. A register linkage with data from NKCx and the National Cancer Registry at the National Board of Health and Welfare will be carried out to determine which women have developed gynecological cancer, cervical cancer and/or pre-cancer (cancer in situ). A follow-up review of reported original cytological (cell samples) and histological (tissue samples) diagnoses will be performed by cytodiagnostics and cytopathologists, to verify the correct diagnosis.

Statistics on collection of non-organized cell samples after a partial negative sample where follow-up is not recommended are produced in aggregated form in the form of an extract from NKCx

Eligibility Criteria:
Inclusion Criteria:

* women with an AGC diagnosis between February 17, 2014 and December 31, 2018
* 23-80 years old
* resident of the Stockholm-Gotland region of Sweden

Exclusion Criteria:

-
Levosimendan Versus Milrinone in Off Pump CABG Surgery

To compare the efficacy of Levosimendan versus Milrinone in supporting hemodynamics during off-pump coronary artery bypass grafting surgery in patients with low ejection fraction.

The major challenge during off-pump coronary artery bypass graft surgery is to maintain optimum hemodynamics by optimizing the intravascular volume and by using some inotropes. However, conventional inotropes such as beta-agonists are associated with tachycardia and arrhythmia which increase myocardial oxygen demand.

Levosimendan is an inodilator which exerts its positive inotropic effect by enhancing the sensitivity of troponin C to calcium without increasing intracellular calcium concentration. Levosimendan also decreases the systemic vascular resistance, so, it increases the cardiac output without increasing myocardial oxygen consumption.

This study aims to compare the efficacy of Levosimendan versus Milrinone in supporting hemodynamics during off-pump coronary artery bypass grafting surgery in patients with low ejection fraction.

Eligibility Criteria:
Inclusion Criteria:

* Elective off-pump coronary artery bypass grafting surgery.
* ejection fraction \< 50%

Exclusion Criteria:

* Patients with severe renal impairment or renal failure.
* Patients on mechanical support (intra-aortic balloon pump)
A Pilot Study to Evaluate a Revised Method of Assessing Food in a Commercial Weight Management Program Format

This study will provide data on two systems for assigning point values to food choices in a diet plan. The primary purpose of this study is to compare the effectiveness of the two systems with regard to changes in body weight.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 25-65 years of age inclusive
* Body Mass Index (BMI) 27.0 -35.0 inclusive.
* Not currently taking a prescription medication for weight loss (e.g. orlistat (Xenical), sibutramine (Meridia), phentermine).
* Not currently taking any over-the-counter weight loss medications or supplement(s).
* Not currently enrolled in commercial weight loss program (e.g. Jenny Craig, Weight Watchers) or self-help group (e.g. TOPS, Overeaters Anonymous).
* Willing and able to commit to regular physical activity (e.g. walking) five days per week as required by study protocol.
* Willing to keep and turn in a daily log/compliance book at the times required by study protocol.
* Willingness and ability to make all scheduled appointments at MUSC as required by study protocol.
* Willingness to make weekly meetings at MUSC.

Exclusion Criteria:

* History of thyroid disease, but not taking medication, or medication dosage changed one or more times over last 6 months. History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable.
* Diagnosed with Type I or Type II diabetes or glucose intolerance, or use of anti-diabetic medications
* History of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve).
* History of major surgery within three months of enrollment.
* History of heart problems (e.g. angina, bypass surgery, MI, etc.) within three months prior to enrollment.
* Presence of implanted cardiac defibrillator or pacemaker.
* Uncontrolled hypertension/high blood pressure.
* Orthopedic limitations that would interfere with ability to engage in regular physical activity.
* Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease.
* History or presence of cancer. Persons with successfully resected basal cell carcinoma of the skin may be enrolled if treatment completed more than 6 months prior to enrollment.
* History of clinically diagnosed eating disorders including anorexia nervosa or bulimia nervosa.
* Women who are pregnant, lactating , trying to become pregnant or unwilling to use an effective means of birth control.
* Participation in another clinical trial within 30 days prior to enrollment.
* Weight loss of more than 5 pounds for any reason over the 30 days prior to enrollment.
* Taking any psychotropic medicine known to influence weight or weight loss
Yoga and Qigong for Elderly Patients With Chronic Low Back Pain

The objective of this study is to evaluate whether yoga or qigong therapy is effective in treating low back pain in elderly patients compared to no therapy (waiting list control). The secondary aim is to compare yoga and qigong.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 65 years of age
* Chronic low back pain since 6 months at least
* Functional Rating Index (FRI) ≥ 2 last 7 days
* Informed consent form signed

Exclusion Criteria:

* Disc prolapse with acute neurological symptoms
* Previous spinal operations
* Severe organic or psychiatric disease conditions, not allowing to participate in the trial
* Use of opioids
* Drug- and alcohol-addiction
* Participation in another clinical trial within the last 6 months
* Participation in yoga or qigong training within the last 12 months
* Planned physical therapy within study duration
Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase

This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of CP-CML with cytogenetic confirmation of Philadelphia (Ph) chromosome
* Ph negative cases or patients with variant translocations who are BCR-ABL positive in multiplex PCR are also eligible
* WHO performance status 0-2
* Laboratory assessments within normal limits
* Written informed consent prior to any study procedures being performed

Exclusion Criteria:

* Known impaired cardiac function
* History of acute or chronic pancreatitis
* Impaired gastrointestinal function or disease that may alter the absorption of study drug
* Concomitant medications with potential QT prolongation, or known to interact with CYP450 isoenzymes (CYP3A4, CYP2C9, and CYP2C8)
* Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
* Patients who are pregnant or breast feeding, or females of reproductive potential not employing an effective method of birth control. Female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug

Other protocol-defined inclusion/exclusion criteria may apply
Perspectives of Receiving Open Versus Minimally Invasive Surgery

This study will examine the perspectives of patients' undergoing surgery for lung or esophageal cancer. It will examine both pre-op and post-op patient perspectives and opinions regarding pain and surgical complications. This study will also assess a general health related quality of life pre-op and post-op. Additionally, it will examine the importance of receiving care close to home and their support system.

Hypotheses:

1. The data will allow investigators to better understand the willingness of patients to participate in prospective, randomized studies comparing minimally invasive and open thoracic surgery. Patients will not be willing to undergo randomization to an open versus minimally invasive surgical procedure.
2. The pain associated with Minimally Invasive Surgery (MIS) will be perceived and documented as lesser than open surgery.
3. Patients may be willing to accept a higher risk of complications or more post-operative pain if they were given the option to be cared for closer to their home.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are surgical candidates for lung or esophageal cancer (entered at pre-op time point)

Exclusion Criteria:

* Below 18 years of age.
Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer

Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.

Prostatectomy 2-8 weeks after completion(standard of care and not a part of study)

Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care).

This protocol evaluated weekly ixabepilone prior to robotic prostatectomy for patients with high risk localized prostate cancer. PSA response rate, tumor margin status and pathologic responses were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Histologic documentation of prostatic adenocarcinoma. Patients with small cell, neuroendocrine or transitional cell carcinomas are not eligible.
* All eligible patients must have a known Gleason sum based on biopsy or TURP at the time of registration.
* Clinically Localized Disease: Patients must have clinical stage T1-T3a and no radiographic evidence of metastatic disease as demonstrated by:
* Either CT or MRI of the abdomen and pelvis, that demonstrate no nodes \> 1 cm: or endorectal MRI(If one or more lymph nodes(s) measures \> 1 cm, a negative biopsy is required.)
* Negative bone scan (with plain films and /or MRI and/or CT scan confirmation, if necessary).(Positive PET and Prostascint scans are not considered proof of metastatic disease.)
* Patients must have high risk disease defined as either:

  * Gleason Score 8-10
  * PSA \> 15 ng/ml
  * Stage T3a
  * Stage T2c and Gleason score of 7
  * Stage T2b, Gleason score of 7, greater than 50% of the cores positive from a single lobe.
* No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, chemotherapy or hormone therapy.
* Patient must be appropriate candidates for radical prostatectomy with an estimated life expectancy \> 10 years as determined by an urologist.
* ECOG PS 0-1
* Age \> 18 years of age.
* Required initial laboratory values:

  * ANC \> 1500/ul
  * Platelet count \> 100,000/mm3
  * Creatinine \< 2.0 mg/dl
  * Serum PSA \< 100 ng/ml
  * Bilirubin \< upper institutional limit of normal (ULN)
  * AST/ALT \< 2.5 X ULN

Exclusion Criteria:

* Active or uncontrolled infection.
* Patients must not have other coexistent medical condition that would preclude protocol therapy.
* Previous severe hypersensitivity reaction to a drug formulated in CremophoreL (polyoxyethylated castor oil).
* Grade 1 or greater neuropathy (motor or sensory) at study entry
Multicomponent Therapy for Fibromyalgia

Therapy for fibromyalgia is a well discussed topic in literature, yet not thoroughly evidence-based. Several unicomponent therapies seem to be benificial. Whereas multicomponent and multidisciplinary therapy gains importance and revealing promising results, the investigators aim to combine two well-known therapies in a program for patients with fibromyalgia.

From clinical experience, a high drop-out rate has been stated. All data will be explored to analyse explanatory factors.


Eligibility Criteria:
Inclusion Criteria:

* woman with fibromyalgia
* between the age of 20 and 50
* agreement with therapy protocol

Exclusion Criteria:

* high indication of depression measured with the Beck Depression Index
Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI

The objective of the proposed work is to determine whether administration for 12 months of romosozumab followed by 12 months of denosumab will maintain bone mass at the knee in subjects with subacute SCI compared to 24 months of denosumab administration alone.


Eligibility Criteria:
Inclusion Criteria:

1. Traumatic motor-complete or incomplete SCI C4-L2 (AIS grade A-C);
2. Duration of SCI less than 6 months;
3. Males and females (premenopausal) between the ages of 18 and 55 years old; and a safe range of BMD right above the knee as determined by study staff review;

Exclusion Criteria:

1. Active and/or history of coronary heart disease or stroke;
2. Bone cancer;
3. Long-bone fracture of the leg within the past year;
4. History of prior bone disease (for example, Paget's hyperparathyroidism, osteoporosis, etc.);
5. Postmenopausal women;
6. Men with known low functioning tests before SCI;
7. Drugs geared toward increasing BMD longer than a six month duration after SCI;
8. As determined by study staff review of my medication history of glucocorticoid administration longer than three months duration within the last year
9. Abnormalities of my endocrine glands such as hyperthyroidism, Cushing's disease or syndrome, etc.;
10. Severe underlying chronic disease (for example chronic obstructive pulmonary disease (COPD), end-stage heart disease, chronic renal failure);
11. Heterotopic ossification (HO) of the distal femur (the knee end of the thigh bone). HO is a condition where bone tissue forms outside of the skeleton. If HO is found in any other area than the distal femur it will not prevent my participation in the study.;
12. History of chronic alcohol abuse;
13. Diagnosis of hypercalcemia (high levels of calcium in the blood);
14. Pregnancy;
15. As determined by study staff review of my medications a bisphosphonate for heterotopic ossification (HO), or other medications to treat osteoporosis other than calcium and vitamin D;
16. Current diagnosis of cancer or history of cancer;
17. As determined by study staff review of my medications, prescribed moderate or high dose corticosteroids (\>40 mg/d prednisone or an equivalent dose of other corticosteroid medication) for longer than one week, not including drug administered to preserve neurological function at the time of acute SCI; and
18. Life expectancy less than 5 years.