cyrilzakka/clinical-trials huggingface dataset:
Functional Electrical Stimulation (FES) Assisted Walking: Enhancement of Walking Function After Stroke

The purpose of this study is to determine if a form of exercise,known as electrical stimulation can improve walking function and other important health outcomes. The hypothesis is that electrical stimulation can enhance the ability to walk for stroke survivors who are unable to walk on their on their own.

A stroke is a devastating life event, that can result in permanent disability. Many people who survive a stroke will experience paralysis on one side of their body. The muscles in one leg may become weaker or stiff to the point that the person can barely walk. Functional electrical stimulation (FES) is an intervention that applies short current pulses to muscles and causes them to contract. Previous work done by our team has used FES in the spinal cord injured population to help restore functions such as walking and grasping by contracting groups of paralyzed muscles in an orchestrated manner. This study seeks to explore whether a thrice weekly FES-assisted walking intervention for a 8 week period can stimulate or improve walking ability in individuals with severe lower extremity paralysis secondary to a stroke. This will subsequently promote opportunities for enhanced social participation and quality of life i.e. enhanced balance, increased independence of activities of daily living etc. for stroke consumers. Comparison: 40 individuals with severe hemiplegia will be randomized to either a thrice weekly control (false) FES training regimen OR a thrice weekly intervention (true) FES training regimen. Prior to randomization, participants will be stratified according to their ability to ambulate (walk). This study will determine if FES can improve or enhance walking ability associated with stroke after 8 weeks of training, and after 4-month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Hemiplegic stroke at least 12 months prior to joining the study.
* Age 65 years or greater.
* Ability to follow instructions and to devote his/her attention to therapy.
* Ability to understand instructions in English and able to provide informed consent.

Exclusion Criteria:

* Severe difficulties with attention such that informed consent cannot be obtained, or that safety or communication would be comprised.
* Ability to walk more that 10 meters during a two minute walk with an average speed greater than 0.8 m/s.
* The presence of skin rashes, allergies or bruises where electrodes would be placed.
* History of seizures, edema in paralyzed limbs or co-morbidities such as Parkinson's Disease, cancer or osteoarthritis to be confirmed by attending physiatrist.
Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in pressure was observed in the external urethral sphincter along with an increase in bladder capacity. In a subsequent study it was demonstrated that Transcutaneous Mechanical Nerve Stimulation (TMNS) in women could induce pressure increment of the external urethral sphincter. A pilot study have since shown that after 6 weeks of stimulation 24 out of 33 women suffering from urinary stress incontinence were able to contract their pelvic floor muscles and had become free of symptoms. Another pilot study has shown promising effect on the overactive bladder syndrome. Furthermore pilot studies in men who are incontinent after a radical prostatectomy have shown promising results. A randomized investigation of TMNS applied in the immediate period after a radical prostatectomy to investigate effects on both continence and erectile function is on going.

The present study aims to treat urinary incontinence in men who are still incontinent more than 1 year after a radical prostatectomy. A medical vibrator is used daily for a period of 6 weeks and the results of the treatment is then evaluated. The participants will be randomized to 2 groups. Group 1 starts vibration treatment at base line and group 2 starts after 6 weeks when group 1 is done. The groups are compared at baseline, at 6 weeks and at 12 weeks.

The stimulation will be performed at the frenulum of the glans penis every day for 6 weeks with an amplitude of 2 mm and a frequency of 100 Hz. Results will be evaluated on the basis of questionnaires, micturition diaries and diaper tests.

If the investigators are able to demonstrate a significant reduction in the incontinence symptoms in the subjects the investigators asses that vibration can be a way of reestablishing normal continence in men after a radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Men who have undergone a radical prostatectomy at least 1 year prior to enrollment
* Incontinence induced by the surgery (at least 8 g/24 hours)
* Capable of understanding study information and following treatment

Exclusion Criteria:

* Incontinence before radical prostatectomy
* Treatment with anticholinergic medications
* Radiation or hormone treatment
* Previous surgical treatment of incontinence
* Acute illness (including infection, trauma and haematuria)
* Faecal incontinence
* Known neurological disease
* Known Bladder pathology on cystoscopy
PREVAIL Interdisciplinary Track: A Pragmatic Randomized Clinical Trial

The goal of this clinical trial is to \[primary purpose learn if a team that involves five types of pain specialists (interventional pain, psychology, pharmacy, nutrition, physical therapy) can treat chronic pain in Veterans. The main questions it aims to answer are:

* Do patients report less pain after six months in the program?
* Do patients report that pain gets in the way of their life less after six months in the program? The researchers will compare participants who participate in the program to those that wait for six months before participating in the program.

Participants will

* Meet with the team of pain specialists to develop a plan to treat their pain
* Receive calls from a coach once per month
* Return to meet with the team of pain specialists for a six-month follow-up appointment
* Fill out surveys


Eligibility Criteria:
Inclusion Criteria:

* Veteran receiving care at the Salem VA Health Care System (Salem VAHCS) per electronic medical record (EMR)
* Patient participating in PREVAIL Interdisciplinary Team Track per EMR
* Chronic Pain Diagnosis: Defined as pain lasting more than three months per EMR

Exclusion Criteria:

* Diagnosis of Mild Neurocognitive Disorder or Major Neurocognitive Disorder based on Diagnostic Statistical Manual of Mental Disorders, 5th edition, Text Revision (DSM-5-TR) per EMR
* Veteran has a current acute physical injury that would artificially elevate pain scores during study period per EMR
* Veteran intends to have a pain-related surgery during the study period per EMR
Health Benefits of Air Purifiers in Primary School Students

This study aims to explore changes in cardiopulmonary function and other health indicators in primary school students with the intervention of air purifiers on a randomized controlled trial.

The investigators will conduct a randomized controlled trial among 110 healthy children in Jiaozuo city, Henan, China. The eligible children will be divided into two groups according to their classes and randomly receive interventions of either true or sham air purifiers. The air purifiers devices in classroom \[air purifiers and fresh air ventilation systems\] will operate during the school time and the devices in bedrooms (air purifiers) operate during the home time in the intervention period. All the participants and investigators will be blinded to the group assignment. Epidemiological questionnaires (i.e., basic characteristics, eating habits, daily schedule, etc.) will be conducted and health indicators (i.e., blood pressure, pulmonary function indicators, fractional exhaled nitric oxide, and fractional exhaled carbon monoxide) and biological specimens (i.e., morning urine, venous blood, exhaled breath condensate, and feces) will be evaluated and collected at baseline and after the completion of intervention period (4 months anticipated).

Eligibility Criteria:
Inclusion Criteria:

* Age of between 8 and 12 years old
* Males and female of ethnic Han
* Subjects who have no plans to change classroom during the intervention period
* Subjects who staying in Jiaozuo city during the intervention period

Exclusion Criteria:

* Subjects with asthma, childhood diabetes, childhood hypertension, and behavioral disorders
* Subjects who plan to transfer or move offsite within six months
* Subjects who decorated or plan to decorate home within six months
* Subjects with smokers in the household
A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension

The purpose of this study is to evaluate the effect of ALN-AGT01 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of ALN-AGT01.

Participants will receive ALN-AGT01 or placebo for the first 6 months of the 12-month double-blind (DB) treatment period. Participants randomized to placebo will be re-randomized at Month 6 to 1 of the 4 initial ALN-AGT01 regimens until the end of the 12-month DB treatment period. Participants randomized to ALN-AGT01 regimens will remain on their originally assigned regimens through remainder of the study.

Eligibility Criteria:
Inclusion Criteria:

* Daytime mean SBP ≥135 mmHg and ≤160 mmHg by ABPM, without antihypertensive medication

Exclusion Criteria:

* Secondary hypertension, orthostatic hypotension
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2× upper limit of normal (ULN)
* Elevated potassium \>5 mEq/L
* Estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73m\^2
* Received an investigational agent within the last 30 days
* Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus, newly diagnosed Type 2 diabetes mellitus
* History of any cardiovascular event within 6 months prior to randomization
* History of intolerance to SC injection(s)
Correlation of Metamorphopsia and Aniseikonia to Retinal Shift Following Retinal Detachment Surgery

Individuals operated for rhegmatogenous retinal detachment will be prospectively evaluated for postoperative retinal shift. Fundus autofluorescence will be used to evaluate retinal shift that will be correlated to visual acuity, metamorphopsia, aniseikonia, and stereopsis.


Eligibility Criteria:
Inclusion Criteria:

* Acute rhegmatogenous retinal detachment, fovea detached, able to signe

Exclusion Criteria:

* Secondary retinal detachment like tractional, serous or with ora serrata dialysis, fovea on
Rasagiline for Gait Treatment

Gait disturbances are very common and are a major cause for losing of independency in patients with advanced Parkinson's Disease (PD). The medical treatment of gait disturbances in advanced PD is very difficult and in many cases the classical dopaminergic treatment has no clinical benefit or even can worsen the instability and increase falls. Rasagiline, a new MAO-B inhibitor who has recently been approved all over the world for the treatment of early and late stages PD has been suggested to have a special effect of gait in patients with advanced PD (LARGO sub-study).


Eligibility Criteria:
Inclusion Criteria:

* Patients with PD who experience motor response fluctuations and have gait disturbances at ON and OFF (TUaG \>10 secs in ON and 14 secs in OFF) treated with a stable dose of antiparkinsonian medications for the last month. Patients must be able to identify both situations
* Able to walk for 2 minutes at the OFF and ON state
* Non-demented (MMSE= or \> to25)

Exclusion Criteria:

* Severe orthopedic problems
* Orthostatic hypotension on basal visit
* Severe, troublesome ON dyskinesias
* Dementia (MMSE \<25)
* Major depression
* Active psychosis or on anti-psychotic medications
* Patients who are unlikely to complete the full protocol.
* Patients who have tried rasagiline and stopped because of side effects or lack of symptomatic effect
* Treatment with selegiline for the last 2 months
* Any contraindication according SmPC
Tumor Characteristics, Pre-transplant Treatments and Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma

Recurrence after liver transplantation for hepatocellular carcinoma (HCC) represents an important cause of mortality for this surgical population. In addition to tumor characteristics, It has been suggested that pre-treatment and sirolimus-based immunosuppression may affect recurrence and survival. With data from the European Liver Transplant Registry (ELTR) database, the aim of this study is to investigate the impact of tumor characteristics, pre-transplant treatment and immunosuppression regimens on survival after liver transplantation for HCC.


Eligibility Criteria:
Inclusion Criteria:

* Hepatocellular carcinoma within transplantation criteria

Exclusion Criteria:

* Disseminated disease
In-Situ Simulation Different Debriefing Methods

The goal of this pre-test-post-test randomized controlled experimental study is to examined the effects of the learning conversation (LC)-based, 3D model-based, and standard debriefing methods on critical thinking, debriefing experience, and satisfaction after in-situ simulation among intensive care unit (ICU) nurses.

A total of 186 ICU nurses working in a training and research hospital participated in the study. Researchers will compare learning conversation (LC)-based, 3D model-based, and standard debriefing methods on critical thinking, debriefing experience, and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Volunterring
* Beclohers degree graduated
* 22- 55 years
* min 1 year to work as a nurse
* open to communication

Exclusion Criteria:

* individuals outside the inclusion criteria
Studying the Neuronal Basis of Human Social Cognition

This proposal aims to study the role that the dorsal prefrontal cortex plays in human social cognition.

Despite ongoing progress in the understanding of social behavior, little is known about the single-neuronal mechanisms that underlie human social cognition. The investigators will obtain single-neuronal recordings from the prefrontal cortex in participants undergoing clinically planned deep brain stimulation (DBS) electrode placement.

The study population will consist of subjects undergoing planned DBS placement. Prospective participants will be selected for surgery irrespective of their participation in the study. After consenting to the study, the participants will be allowed to withdraw from participation at any time. No control subjects will be used. Instead, each subject will act as their own control based on task performance.

For the study, neuronal recordings will be integrated within planned neurosurgical care and will be obtained from the prefrontal cortex as participants perform a brief behavioral task. During recordings and prior DBS placement, the participants are normally asked to make movements or answer questions based on verbal cues to aid in targeting the correct areas. The participants will be additionally asked to perform a brief linguistic-based task in which scenarios containing social agents are presented to the participants and in which they have to verbally describe/answer questions about them. Following cortical recordings and stimulation, the standard clinical procedure and DBS electrode placement proceeds as planned. The neuronal and behavioral data will then be analyzed off-line.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or older
2. patients able to give informed consent

Exclusion Criteria:

1. Children under 18
2. Significant co-morbidities
3. Claustrophobia or general anxiety that may impact intraoperative testing
4. Use of CNS-active medications including stimulants and antipsychotics which may alter
5. Pregnancy
6. Operative events that will require expedition of the surgery.
7. Poor tolerance of testing by the patient
8. Increased abnormal cortical excitability
9. Necessity to administer drugs that will interfere with mapping
Retrospective Observational Trial on Reasons for Withdraw of Adjuvant Tamoxifen in Breast Cancer Patients

Retrospective observational trial on reasons for withdraw of Adjuvant Tamoxifen in Breast Cancer patients


Eligibility Criteria:
Inclusion Criteria:

* Breast Ca Patients with surgery and withdraw of adjuvant treatment with Tamoxifen for Tam related AEs
* Documented reasons for treatment withdrawal

Exclusion Criteria:

* enrollment in other studies
* treatment withdraw for other causes than Tam related AEs
the Role of MRI in Evaluation of Low Back Pain

This study aims to evaluate the role of MRI to diagnose different causes of low back pain among middle aged females at Sohag university hospital.


Eligibility Criteria:
Inclusion Criteria:

- middle aged female patients aged from 40 to 60 years with complaints of low back pain who were referred to the department of radiology of sohag university hospital for Lumbosacral spine MRI.

Exclusion Criteria:

* Male patients.
* female patients aged less than 40 years or more than 60 years.
* Contraindication to magnetic resonance imaging including cochlear implant, pacemaker, claustrophobia.
* Non-cooperative sick patients.
Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer

Neuropathic pain is difficult to control because it is only partially sensitive to opioid analgesics, and requires the addition of other therapies such as antidepressants and epileptics. Ziconotide is a drug that is used to treat neuropathic pain in patients who have had inadequate pain control with prior combination of medicines.

The purpose of this study is to evaluate the effects and the tolerability of intrathecal ziconotide in cancer patients suffering from severe neuropathic pain not controlled by previous therapies.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of neoplasm
* Neuropathic pain level VASPI \> or = 6 (0-10 scale)
* Inadequate pain relief with opioid analgesics and adjuvants
* Age \> or = 18 years
* Performance status ECOG 0-2
* Life expectancy at least one month
* Adequate contraception in women of child-bearing potential
* Signed Informed Consent

Exclusion Criteria:

* Use of experimental drugs within previous 30 days
* Pregnancy or lactation
* Contraindication to the use of intrathecal analgesics, including active infection or conditions that could alter the circulation of cerebrospinal fluid
* Presence of cerebral metastasis
* INR \> 2
* Contraindication to the use of ziconotide
* Unable or unwilling to provide informed consent
Combination of Methotrexate(MTX) and Actinomycin(ACTD) in the Low Risk Gestational Trophoblastic Neoplasma （GTN） Patients With Score of 5-6

In this study, a prospective, multicenter randomized controlled study was conducted to compare the clinical efficacy and toxicity response of combination MTX+ACTD multi-course regimen in low-risk GTN patients with score 5-6 with standard MTX single-drug multi-course regimen.

The improved prognostic scoring system has been in use for more than 20 years in GTN patients. However, there are also more and more clinical evidences showing that the International Federation of Obstetrics and Gynecology（FIGO）/world health organization (WHO) system is not so perfect. The main problem is that a considerable number of patients are resistant to initial chemotherapy, 25-35% occur in low risk (≤ 6 points), and 70-80% occur in patients with a score of 5-6 points. According to reference, the drug resistance factors include high HCG level before chemotherapy, metastatic foci, histological diagnosis of choriocarcinoma, etc. However, according to the score before 2000, there is a moderate risk score group with 4-6 points, i.e. most of the single drug resistance to the initial regimen occurs in the previous moderate risk score group.Therefore, most scholars believe that there are grey areas with a score of 5-6. According to the analysis of 5-6 scores in the scoring system, the prognosis of single-drug chemotherapy is poor, and the initial remission rate is only about 30-40%. Therefore, many authors call for the current staging scoring system to be revised to a more accurate model so that some patients who may be drug resistant can adopt more effective plans at the beginning of treatment.

In this study, the investigators plan to conduct a prospective, multicenter randomized controlled study to compare the clinical efficacy and toxicity response of combination MTX+ACTD multi-course regimen in low-risk GTN patients with score 5-6 with standard MTX single-drug multi-course regimen. The experiment arm of the trial is multi-course combination of MTX and ACTD. The primary endpoint is complete remission rate of primary treatment or failure of primary treatment. Drug toxicity is surveillanced.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of gestational trophoblastic tumor;
* Patients with prognosis score of 5 and 6
* Primary chemotherapy (preventive chemotherapy is not included);
* Physical strength grade: Karnofsky score ≥ 60;
* WBC ≥ 3.5× 109/L, ANC ≥ 1.5× 109/L, PT ≥ 80× 109/L, serum bilirubin ≤ 1.5 times of normal high limit, transaminase ≤ 1.5 times of normal high limit, BUN, Cr≤ normal;
* Follow-up and good compliance;
* Sign the informed consent form.

Exclusion Criteria:

* Pathological diagnosis is intermediate trophoblastic tumor, including PSTT and ETT；
* There are serious or uncontrollable medical diseases, which are not suitable for chemotherapy;
* Those who receive clinical trials of other drugs at the same time.
* Those who receive Chinese medicine.
Newborn Feeding and Infant Phenotype

Breast feeding is believed to be beneficial to long-term health but how these effects are mediated is unknown. I suggest that this may be through effects on body composition and metabolism.

I will compare adipose tissue and liver fat deposition in healthy, full term breast and formula fed infants babies shortly after birth and around 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy baby
* Term baby
* Appropriate weight for gestational age (UK - WHO 2009 growth charts)

Exclusion Criteria:

* Infants of diabetic mothers
* Infants of smokers
* Infants fed non-commercial or non-cows milk based infant formulae
Safety, Tolerability and Efficacy of ATL-104 in Oral Mucositis

This purpose of this study is to investigate whether ATL-104 is safe and well tolerated, and whether it shows evidence of efficacy in mucositis in patients undergoing PBSCT

Mucositis is a serious side effect of cancer therapy and Peripheral Blood Stem Cell Transplant (PBSCT) which requires appropriate and effective management. Mucositis is a condition in which there is inflammation and ulceration of the mouth, throat and gut caused by damage to the mucosal barrier induced by chemo- and radiotherapy. Symptoms include pain, nausea, abdominal cramping, and vomiting. This study will investigate whether ATL-104, when administered as a swallowable mouthwash, is safe and well tolerated in patients undergoing PBSCT and to investigate its potential to reduce the level of severity of mucositis associated with PBSCT.

Eligibility Criteria:
Inclusion Criteria:

* Patients with haematological malignancies undergoing chemotherapy in association with PBSCT

Exclusion Criteria:

* Clinically significant conditions that would exclude the patient receiving chemotherapy in association with PBSCT
* Visible oral disease
* Significantly reduced platelet and neutrophil count