cyrilzakka/clinical-trials huggingface dataset:
Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

A study to compare electrophysiologic activity of epidural stimulation and dorsal root ganglion stimulation, as well as quantify changes in motor performance with both types of stimulation over the course of 10 rehabilitation sessions.

This study aims to expand the understanding of how electrical spinal stimulation enables function, specifically the pathophysiological mechanisms of action underlying spinal electrical stimulation after SCI, and to address the gap in knowledge of spinal sensorimotor network inputs and outputs generated by spinal electrical stimulation in humans with SCI.

Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury due to trauma located at or above the tenth thoracic vertebrae
* American Spinal Injury Association grading scale of A, B, C, or D
* Intact spinal reflexes below the level of SCI
* SCI must have occurred at least 1 year prior to study enrollment
* At least 22 years of age
* If female, must be willing to use medically-acceptable method of contraception during study participation

Exclusion Criteria:

* Currently a prison inmate, or awaiting trial, related to criminal activity
* Pregnancy at the time of screening for trial enrollment
* Active, untreated urinary tract infection
* Unhealed decubitus ulcer
* Unhealed skeletal fracture
* Spinal abnormality that may impede percutaneous implantation of spinal electrodes
* Untreated clinical diagnosis of psychiatric disorder
* Joint contractures that impede typical range of motion
* Non-MRI-compatible implanted medical devices
* Other implanted stimulation devices (e.g. deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, etc.)
* Undergoing, or planning to undergo, diathermy treatment
* Active participation in an interventional clinical trial
* History of clinically-diagnosed cardiopulmonary disorder, such as severe orthostatic hypotension, which may impede participation in rehabilitation activities such as changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
* History of frequent and/or severe autonomic dysreflexia
* History of seizure disorder
* Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study
Investigation of The Effect of Pelvic Floor Exercise Programme in Elderly.

Alteration of hormonal structure and decreasing of muscle tissue with aging causes pelvic floor dysfunction. Over age of 65 so many factors such as decrease in volume of muscle tissue, decrease in the amount of estrogen / testosterone, and low level of physical activity cause problems such as incontinence, prolapse, constipation and sexual dysfunction The aim of this study is to investigate the effectiveness of pelvic floor exercise program on sexual dysfunction, incontinence, quality of life and physical activity level in elderly.

Pelvic floor problems including prolapse, voiding and defecation dysfunction have been seen in approximately 37% of women aged 60-79 years and incontinence is the leading pelvic floor dysfunction. The International Incontinence Society (ICS)defines that all types of involuntarily urinary leakage as urinary incontinence. The incidence of urinary incontinence is 26.6% in women aged 65-74 and 41.8% in patients aged 75 and over. Sexual dysfunction is also frequently encountered problem in pelvic floor disorders in people older than 65 years. The aim of this study is to investigate the effectiveness of pelvic floor exercise program on sexual dysfunction, incontinence, quality of life and physical activity level in elderly. Pelvic floor exercises programme contains different contractions of pelvic floor muscle. Each exercises have slow and fast twitch muscle exercise contraction.

Eligibility Criteria:
Inclusion Criteria:

To be aged over 65 To attend all exercise class Not to be communication problem

Exclusion Criteria:

To have neurogenic bladder To have metastatic prostate or ovary cancer To have enfection in urinary tractus To have pelvic organs malign diseases
Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A

This trial is conducted globally. The aim of the trial is to evaluate the safety and efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in subjects with Haemophilia A.


Eligibility Criteria:
Inclusion Criteria: - Male patients with severe congenital haemophilia A (FVIII activity below 1%, according to medical records) - Documented history of at least 150 EDs (exposure days) to other FVIII products - At least 12 years and body weight at least 35 kg (except for Croatia, France, Russia, Israel and the Netherlands where the lower age limit will be 18 years) Exclusion Criteria: - Previous participation in this trial defined as withdrawal after administration N8-GP - Any history of FVIII inhibitors - FVIII inhibitors above or equal to 0.6 BU/mL at screening - HIV (human immunodeficiency virus) positive, defined by medical records with CD4+ (T-lymphocyte subtype) count below or equal to 200/mcL or a viral load of more than 400000 copies/mL. If the data is not available in medical records within last 6 months, CD4+ will be measured at the screening visit - Congenital or acquired coagulation disorders other than haemophilia A - Previous significant thromboembolic events (e.g. myocardial infarction, cerebrovascular disease or deep venous thrombosis) as defined by available medical records - Platelet count below 50,000 platelets/mcL (laboratory value at the screening visit) - ALAT (alanine aminotransferase) above 3 times the upper limit of normal reference ranges at central laboratory - Creatinine level equal to or greater than 1.5 times above upper normal limit (according to central laboratory reference ranges) - Ongoing immune modulating or chemotherapeutic medication
Effect of D-cycloserine on Treatment of Posttraumatic Stress Disorder (PTSD) in Youth

The purpose of this study is to show whether D-cycloserine in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of posttraumatic stress disorder (PTSD) in 7-12 year old children.

While most individuals with PTSD treated with cognitive behavioral therapy (CBT) show improvement, they still have some enduring symptoms and functional impairment. Accordingly, there is a need for treatment advances.

D-cycloserine (DCS), an antibiotic that has been used for over 50 years, has also been found to have positive effects on cognition and anxiety. DCS was found to enhance learning and memory, and also facilitates extinction of fear reactions. However, DCS only produces an extinction effect when paired with behavioral training, not when simply given alone. Thus, the medication only needs to be given for seven doses in this research and youth do not need to take the medication long term. The research also includes a three-month follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* Certain number of PTSD symptoms plus functional impairment
* Must be able to swallow pills

Exclusion Criteria:

* Serious kidney or liver disease
* Epilepsy
* Bipolar
* Psychosis
Is Medicinal Cannabis an Effective Treatment for Tourette Syndrome in Adolescents? a Pilot Study

This is a single site, pilot double-blind, randomized, placebo-controlled, cross-over study of 10 participants comparing medicinal cannabis (THC:CBD 10:15 oil) with placebo in reducing tics in adolescents aged 12 - 18 years with severe Tourette Syndrome (TS).

The primary objective of this pilot study is to evaluate all elements of the study design (recruitment strategy, study duration, study procedures, study medication tolerance and outcome measures) to assess if they are acceptable and feasible for the conduct of a full-scale randomized controlled trial of THC:CBD 10:15 oil to reduce tic severity in adolescents with TS.

The secondary objective of this study is to collect preliminary data on the safety of oral THC:CBD 10:15 oil in adolescents aged 12 to 18 years with TS.

As an exploratory aim data from clinician- and parent-rated measures will be compared across the phases to explore for a signal of efficacy on primary (tic reduction) and secondary (premonitory urges, obsessive compulsive behaviors, Attention Deficit Hyperactivity Disorder \[ADHD\] symptoms) outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 12 - 18 years of age;
* DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) diagnosis of TS as assessed by the study clinician;
* TS severity defined as a score of 20 or higher on the Total Tic Severity section of the Yale Global Tic Severity Scale;
* No changes in either medication or other interventions in the 4 weeks prior to randomization, and intention to remain on same dose for the duration of the study;
* Participant and family have the ability to comply with the protocol requirements, in the opinion of the investigator;
* Agrees not to drive for the duration of the study.

Exclusion Criteria:

* Non-English speaking parents;
* Participant history of psychosis, schizophrenia, bipolar disorder, or major depressive disorder, or a family history of psychosis;
* Taking anti-epileptic medications which interact with medicinal cannabis: clobazam, mTOR (mammalian target of rapamycin) inhibitors (e.g sirolimus, tacrolimus), anti-cancer agents, citalopram \>20mg/day, escitalopram \>10mg/day;
* Abnormal liver function tests defined as ALT (alanine transaminase) \> twice ULN (upper limit of normal);
* Current use of illicit drugs or medicinal cannabis, or use in the 4 weeks prior to screening;
* Pregnant or intending to become pregnant during the study, or breastfeeding;
* History of clinically significant suicidal thoughts in the prior 12 months.
Group B Streptococcus (GBS) Polymerase Chain Reaction (PCR) Concordance Study

The investigators are comparing three different methods of testing for an infection which is commonly found in women. The infection is caused by a bacterium called Group B Streptococcus. About 10-30% of women carry GBS in the vagina or rectum.

During labour this infection can be passed to the neonate. This can lead to the baby developing a serious infection.

However, research has shown that if antibiotic treatment is given to GBS carrying women during labour most of these infections can be avoided.

A new bedside test known as PCR has been shown to produce a GBS diagnostic result in less than an hour. In clinical trials conducted in the US and France this method has been shown to be more accurate than either prenatal vaginal swabs or risk factor assessment. For this reason, PCR may be helpful in screening and treating GBS positive women in the UK.

In this study the investigators will compare each of the following three methods of diagnosis to a gold standard.

* Prenatal vaginal culture swab (at 35 to 37 weeks gestation)- The US approach.
* Risk factor assessment (at the time of admission for labour)- The UK approach
* The new PCR test (at the time of your labour admission)

The investigators will compare the accuracy of each of these methods with the most accurate method for determining the GBS status during labour. This 'most accurate' method is a highly sensitive swab test which unfortunately takes several days to produce a result. For this reason this test will not tell the investigators whether prophylactic antibiotics may be useful during labour (Receiving them after birth is ineffective).

If PCR is shown to be a more accurate method of identifying GBS positive women this may help to reduce the number of infections in new born infants and as a result may help to save lives.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be included in the study if they are;
* 18 years or older
* Pregnant and planned admission to Portland Hospital whether full-term or otherwise.
* Willing and able to give informed consent prenatally.

Exclusion Criteria:

* Scheduled for non vaginal birth
A Retrospective Cohort Study Outcome of Treatment in Asymptomatic Stage 4 Colorectal Cancer

In asymptomatic Stage 4 colorectal cancer, the treatment varies between many hospitals and countries. Some studies found that primary tumor resection had better survival rates and a lower risk of mortality. But many studies found significant benefits in survival in sub groups of the population such as age less than 70 years, WHO performance status \<2, no extra-hepatic metastasis, liver tumor burden \<50%. However some studies showed no survival benefits in primary tumor resection. So this study will focus on survival, adverse events, complications in primary tumor resection and no primary tumor resection in asymptomatic Stage 4 colorectal cancer.

The retrospective study of patients in asymptomatic Stage 4 colorectal cancer received treatment at Ramathibodi Hospital and excluded symptomatic primary tumors such as obstruction, perforation that required surgery, carcinomatosis peritoneii, and patients with secondary cancer diagnosis in the past 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic stage IV colorectal cancer
* pathological prove adenocarcinoma
* age \>18 years
* no primary tumor related symptom
* ECOG performance status \<2

Exclusion Criteria:

* symptomatic primary tumor such as obstruction , perforation that required surgery
* carcinomatosis peritoneii
* patients with secondary cancer diagnosis in 5 years
Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry

Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry (CoCCA) is a single-center observational registry of patients hospitalized for acute ischemic cerebrovascular disease (AICVD) with atherosclerotic changes in both cerebral and coronary arteries.

This registry aims to establish quantified risk stratification and prognostic models, as well as suggest effective diagnostic and therapeutic strategies.

Atherosclerosis has exerted huge global burden as the common pathological process underlying ischemic heart disease and cerebrovascular disease. A substantial portion of acute ischemic cerebrovascular disease (AICVD) patients have both cerebral and coronary atherosclerosis, which is an omen of poor outcomes. But there is large evidence gap in these high-risk patients' prognosis-related factors, limiting the improvement of care quality.

Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry (CoCCA) is a single-center prospective observational registry of patients hospitalized for AICVD with atherosclerotic changes in both cerebral and coronary arteries.

This registry aims to establish quantified risk stratification and prognostic models, as well as suggest effective diagnostic and therapeutic strategies.

The clinical, imaging and laboratory information will be collected at the baseline. During an estimated 5-year follow-up, the vessel-related diagnostic or monitoring procedures, treatment, functional status and new vascular events will be recorded by web-based patients' self-reports, investigators' regular telephone visits.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as ischemic stroke or transient ischemic attack (TIA).
2. Less than 30 days after onset of ischemic stroke or TIA symptoms.
3. Extracranial or intracranial cerebral atherosclerosis confirmed by vascular ultrasound or CT angiograpgy or MR angiograpgy or digital substraction angiography.
4. Coronary atherosclerosis confirmed by CT angiograpgy or MR angiograpgy or digital substraction angiography; or with myocardial ischemia symptoms confirmed using electrocardiogram or echocardiography or cardiac MR; or with a history of percutaneous coronary intervention or coronary artery bypass graft.

Exclusion Criteria:

1. With malignant tumors or poor organ functions or hematologic diseases, whose estimated life expectancy is less than 5 years.
2. Patients refuse to participate in the research.
Lactate Acidosis in Postoperative Hearts

This is a single-center, observational study. Investigators aim to characterize the metabolism of lactate in children over the first forty-eight hours following cardiac surgery. Blood samples will be obtained up to 12 timepoints. Samples will be analyzed for concentration of pyruvate. Results will be compared to standard of care laboratory results for lactate and other direct and indirect measures of cardiac output.

Investigators will characterize the etiologies of hyperlactatemia predominantly present at serial postoperative timepoints in children recovering from cardiac surgery by following lactate levels and the lactate-to-pyruvate ratio over the first 48 post-operative hours and correlating them with cardiac output as determined by conventional markers and physical exam. Investigators expect to validate the assumption that in children recovering from heart surgery whose cardiac output is apparently normal, hyperlactatemia (if seen) is predominantly due to impaired lactate clearance or metabolism, while in those whose cardiac output is low, it is predominantly due to inadequate oxygen delivery. Blood samples will be obtained up to 12 timepoints (arrival at the intensive care unit postoperatively, hour 1, hour 2, hour 3, hour 4, hour 6, hour 8, hour 10, hour 12, hour 24, hour 36 and hour 48 postoperative) or only at up to 6 time points (approximately Hour 0, 2, 4, 6, 8, and 12) for infants under 10 kg as described below. . Samples will be analyzed for concentration of pyruvate. Results will be compared to standard of care laboratory results for lactate and other direct and indirect measures of cardiac output.

Eligibility Criteria:
Inclusion Criteria:

* All immediately post-operative cardiac patients admitted to the pediatric cardiac intensive care unit (PCICU)

Exclusion Criteria:

* Lack of parental or patient consent, or patient assent when applicable, including non-English speakers and wards of the state
* Dosing weight less than 4 kg\*
* Cardiac catheterization being the only operative procedure
* Severe hepatic dysfunction at any time during the hospital course
* Seizures during the study period
* Sepsis during the study period
* Need for extracorporeal membrane oxygenation or continuous renal replacement therapy
* Known congenital myopathy, ataxia, polyneuropathies or inborn errors of metabolism including congenital lactic acidosis and other mitochondrial disorders
* Primary hypoventilation
* Malignancies
* Fanconi syndrome
* Wernicke encephalopathy
Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis

The purpose of this study is to determine the safety and the immunologic effects of supplementation with low-dose and high-dose cholecalciferol (vitamin D3) in patients with multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Between ages of 18-55 years (inclusive)
* Serum 25(OH) vitamin D levels between 20-50 ng/mL and a candidate for vitamin D supplementation
* Patients with or without immunomodulatory therapy for RRMS
* Diagnosis of multiple sclerosis

Exclusion Criteria:

* Serum 25(OH) vitamin D deficient level \< 20 ng/mL
* High dose vitamin D supplementation in the past 3 months
* Pregnancy
* History of tuberculosis, hyperparathyroidism, sarcoidosis or kidney stones
* Baseline serum creatinine above 1.5
* Hypersensitivity to vitamin D preparations
* Milk allergy
* Unable to consent
Image Content Analysis of Dural-axis Rotational Versus Standard Coronary Angiography

The investigators hypothesized that dual-axis rotational coronary angiography was non-inferior to standard coronary angiography with respect to diagnosis of coronary artery disease.

The prior studies have demonstrated that dual-axis rotational coronary angiography (DARCA) is associated with lower contrast usage and radiation exposure compared with standard coronary angiography (SA). Single-axis rotational coronary angiography (RA) has been proved by previous studies without any reduction in diagnostic accuracy compared to SA. However, the rotational protocol is obvious different between DARCA and single-axis RA. A recent study has assessed the diagnostic accuracy of DARCA, but this study was not designed for image content analysis and the number of patients included did not provide sufficient statistical power to allow a valid comparison of DARCA with SA. The diagnostic accuracy of DARCA aroused our attention.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years old, \<80 years old
* a clinical indication for diagnostic coronary angiography to evaluate possible coronary artery disease

Exclusion Criteria:

* Pregnancy
* Known allergy to iodinated contrast
* Patients who had received iodinated contrast material within the last week or were unable to give consent
* Renal insufficiency (\>1.5mg/dL)
* Acute myocardial infarction within one week
* Cardiogenic shock
* heart function worse than New York Heart Association functional class III
* Left main coronary artery disease
* Prior coronary artery bypass graft treatment
* Prior percutaneous coronary intervention treatment
Effectiveness of Kinesio Taping On Balance In Patients With Stroke

The aim of this study is to investigate the long term effects of Kinesio taping applied on ankle and peroneal muscle in patients with stroke.

Stroke is a common neurological problem and is one of the major causes of disability and death (1,2). In stroke patients, the mortality rate is approximately 30%, and there is an increase in the morbidity rate after stroke occurrence. In addition, stroke is one of the main factors in increases in the burden of health care expenses during adulthood (3).

There is a constant requirement for specific data about stroke rehabilitation methods for achieving evidence-based rehabilitation guidelines.To investigate the effects of repeated correction taping applied on the ankle and peroneus longus and peroneus brevis muscles on balance and gait in patients with stroke. Therefore, the aim of this study is to assess the long term effect of KT applied on ankle and peroneal muscle on both dynamic and static balance in patients with stroke.

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate
* Diagnosed with Stroke
* Mini-Mental State Test score equal or above 25
* Modified Ashworth Scale Score lover then 3
* Able to walk 10 meter independently

Exclusion Criteria:

* Secondary neurological diseases
* Cognitive problems