cyrilzakka/clinical-trials huggingface dataset:
Effects of Functional Electrical Stimulation Cycling Versus Cycling Only on Walking and Quality of Life in MS

This study will seek to determine the benefits that FES-LE cycling has over cycling alone on walking performance and quality of life in people with multiple sclerosis.

Functional Electrical Stimulation (FES) is a rehabilitation tool that stimulates nerves via electrical current, causing muscles to contract. When FES is appled to leg muscles during stationary cycling the legs move in a fixed rhythmical pattern. Previous studies have demonstrated that FES during cycling is a safe and effective exercise for individuals recovering from spinal cord injury or stroke, but few have applied this tool to a progressive disorder, such as multiple sclerosis (MS). The aim of this study is to assess the immediate and short-term effect of an 8-week training program comparing FES lower extremity cycling to cycling without FES. Twenty volunteers with MS will participate. They will be randomly assigned to a training group. This study examine the effects of training on quality of life, endurance, walking speed, and step quality. Participants will sign an informed consent and complete a questionnaire that includes medical history and demographic data. Before training, immediately after training finishes and one month after training, self-report questionnaires, timed walking tests will be completed. During the walking tests, step quality and speed will be measured with a sensor that is worn on a belt

Eligibility Criteria:
Inclusion Criteria:

* Medical Diagnosis of MS
* Patient-determined Disease Steps score between 3.0 and 6.0 inclusive
* Ability to attend training sessions 3 times per week for an 8-10 week period
* Passing a submaximal exercise test
* Adequate hip range of motion (at least 110 degrees)
* Adequate knee range of motion (10-90 degrees)

Exclusion Criteria:

* Cognitive deficits that would interfere in ability to sign consent and understand the procedures for the study.
* History or presence of other neurological pathologies that interfere with movement
* Received physical therapy within the last 4 weeks prior to the study
* History of an acute exacerbation of their MS symptoms within 4 weeks prior to the study
* Immunosuppressive or steroid therapy within the past 4 weeks
* Significant spasticity in the legs that interferes with the cycling motion
* History of congestive heart failure
* Coronary Artery Disease
* Uncontrolled Hypertension
* History of epilepsy or seizures
* Cardiac demand pacemaker or implanted defibrillator
* Unhealed fractures in the legs
* Pressure sores or open wounds on the legs
* Pregnant or trying to conceive
Expanding the Pool in Lung Transplantation

To perform a study (20 patients) utilizing Hepatitis C positive (HCV Ab+/NAT -) donor lungs for hepatitis C negative recipients with post-operative surveillance and treatment only if a recipient infection occurs.

The investigators are proposing a study of efficacy, in which positive donors will be used for HCV negative patients. Following lung transplantation patients will undergo HCV antibody, virus PCR, and liver function testing. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Sofosbuvir/velpatasvir therapy.

This initial study would enroll 20 patients and utilize donors that are young, otherwise healthy whom are Hepatitis C antibody positive but Nucleic Acid Amplification Testing (NAT) negative (HCV Ab+/NAT-). The recipients would be limited to those patients who have previously consented to receive a high risk lung transplant, consented to participant in this study, and who are physiologically optimized for transplantation (e.g., low risk for lung transplantation).

Eligibility Criteria:
Inclusion Criteria:

* Patients who sign the informed consent for this study
* Patients whom agree to receive a PHS high risk organ
* Patients listed for heart transplantation
* Age 18-65

Exclusion Criteria:

* Patients who do not sign informed consent for this study
* HIV Seropositivity
* HBV Seropositivity (HBcAb and/or HBsAg positive)
* Abnormal liver enzymes - 3 times the normal liver function values (Bilirubin, INR, AST, ALT)
* Acute or chronic renal insufficiency (creatinine clearance \<50 ml/min) or history of dialysis
* Patients on ECMO
* Respiratory insufficiency requiring mechanical respiratory support (ventilator, BiPAP)
* Liver insufficiency
* Prior history of hepatitis C
* Allergy to Sofosbuvir/velpatasvir
* Pregnancy
A Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (Pegasys) and Adeforvir Dipivoxil (ADV) in Participants With Lamivudine-Resistant Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B

This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target sample size is 255 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants 18-65 years of age
* Hepatitis B surface antigen (HBsAg)-positive, HBeAg-positive, and anti-HBs-negative for greater than or equal to (\>=) 6 months
* Receiving lamivudine currently, and for \>=6 months
* hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) decreased \>=2 log during lamivudine treatment on \>=1 occasion
* Absence of cirrhosis confirmed by liver biopsy in previous 6 months

Exclusion Criteria:

* Other drugs with activity against HBV within the prior 6 months, except lamivudine
* Antiviral, anti-neoplastic, or immunomodulatory therapy less than or equal to (\<=) 6 months before study - Active infection with hepatitis A, C, or D virus, or human immunodeficiency virus
* Decompensated liver disease
* Medical condition associated with another chronic liver disease
A Viveve Experience Normalizes Untreated Selective Serotonin Reuptake Inhibitor (SSRI) Sexuality Syndrome

A pilot study to investigate non-surgical treatment for women who suffer from sexual complaints secondary to SSRI Sexuality Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Currently using SSRI for 3 months at a stable dose

Exclusion Criteria:

* Pregnant, currently breastfeeding, or breast-fed within the last 6 months
* Has any implantable electrical device that could potentially be affected by use of radiofrequency.
Promoting Improved Functioning Among People Experiencing Stressful Situations

The iCOVER intervention was developed to rapidly restore functioning in individuals experiencing an Acute Stress Reaction (ASR). iCOVER is undergoing widespread adoption but has not been tested for efficacy. iCOVER was designed to be administered by peers, paraprofessionals, or medical personnel in 60-120 seconds, including in military operational environments. The term iCOVER is an acronym that summarizes the six specific steps of the intervention: (1) identify that an individual is experiencing an ASR; (2) Connect with the individual through word, eye contact, and physical touch to draw them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish order of events - briefly review what has happened, what is happening, and what will happen to orient the individual; and (6) Request action to re-engage the individual in purposeful behavior.

Participants will be randomly assigned to one of three groups: iCOVER, usual care, or physical presence with reassurance. Investigators have elected to use two different control conditions, in order to examine the reliability of the iCOVER intervention in comparison with two typical responses to individuals experiencing an ASR (i.e., physical presence with reassurance, no specific treatment).


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years and ≤ 50 years of age (if age not known, appears to be)
* In the emergency department as a patient or loved one of a patient
* If a patient, anticipated to be discharged to home from the emergency department after evaluation
* Exhibiting visible signs of distress Richmond Agitation and Sedation Scale ((RASS) (+1 to +3)) or dissociation (awake and alert but reduced responsiveness)
* Likely able to speak English

Exclusion Criteria:

* Known pregnancy
* Prisoner or in custody
* Known history of psychosis or bipolar disorder
* Known or suspected drug intoxication
* Known history of substantial cognitive impairment
* Known or suspected altered mental status due to traumatic brain injury
* Known active psychosis, suicidal ideation, or homicidal ideation
* Unable to use both hands (e.g. due to sprain)
* Any other history or condition that would, in the site investigator's judgement, indicate that the individual would very likely be non-compliant with the study or unsuitable for the study (e.g. might interfere with the study, confound interpretation, or endanger participant)
The Effect of Plant Sterols on Vascular Function

The main aim of the study is to investigate, in humans, the effect of plant sterols on vascular function by measuring flow-mediated dilation (FMD).

This study also aims to study the effect of plant sterols on pulse wave velocity (PWV), aortic augmentation index (Aix), central blood pressure (CBP), office blood pressure (BP), blood lipids and plasma plant sterol concentration. At last, the effects of plant sterols on z-scores of circulating biomarkers of endothelial dysfunction and low-grade inflammation will be assessed.

For all study outcomes, effect sizes and 95% confidence intervals will be estimated.

Hypothesis: Based on available evidence, it is hypothesized that plant sterols modestly increase FMD.

Plant sterols are well known for their LDL-cholesterol lowering benefit. Elevated cholesterol and especially LDL-cholesterol concentrations are established risk factors for coronary heart disease (CHD) and reducing these concentrations by dietary modification or drug treatment have been shown to reduce the risk of CHD. Direct evidence supporting a reduced risk of CHD has so far not been generated. Investigating the effects of consuming plant sterols on intermediate risk factors beyond cholesterol-lowering is therefore warranted.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy men and post-menopausal women
* BMI ≥ 18 and ≤ 30 kg/m2.
* Aged between 40 - 65 years.
* Having elevated LDL-cholesterol concentrations at screening (130-190 mg/dL or 3.4-4.9 mmol/L).
* Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by the research physician

Exclusion Criteria:

* Having (previous) cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure), systemic inflammatory conditions or diabetes mellitus.
* Use of over-the-counter and prescribed medication which may interfere with study measurements (i.e. statins, ezetimibe, fibrates, diabetic drugs, ARB and ACE inhibitors), to be judged by the Principal Investigator.
* Use of medical treatment for elevated TG concentrations.
* Use of antibiotics in the three months prior to screening.
* Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.
Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

The purpose of this study is to collect pilot data on the feasibility of recruiting, eliciting informed consent, assessing, treating, and following patients aged 60 and older with bipolar mood disorders.

Study specific aims are:

* to establish a recruitment, referral, and collaborative network for elderly bipolar patients, in collaboration with the NIMH funded STEP-BD
* to establish an outpatient treatment clinic at the Bellefield Towers site of the NIMH funded Intervention Research Center for Late Life Mood Disorders
* to implement standardized care pathways compatible with STEP-BD treatment algorithms for mood stabilizing pharmacotherapy.
* to document short- and long-term treatment response with respect to affective symptoms, sleep, general life functioning, cognition, treatment-emergent side effects
* to establish the clinical infrastructure necessary for randomized controlled clinical trials and for clinical research training in bipolar mood disorders of late-life.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of Bipolar Disorder
* Folstein Mini-Mental Status Exam score of 18 or higher

Exclusion Criteria:

* Medical condition that precludes the use of both lithium and depakote
* If mood disturbance is deemed an organic mood disorder (i.e., iatrogenic, secondary to medication)
* If refuse to designate someone who the study staff can contact about bipolar symptoms, concerns about the subject's health, in an emergency, and/or inability to reach the subject.
Early Diagnosis of Oral Cancer by Detecting p16 Methylation

The purpose of this study is to verify the function of p16 methylation diagnostic reagents in early diagnosis of oral cancer.

Background:Oral epithelial dysplasia (OED) is one of the common precancerous lesions among Chinese adults. To investigate the clinical predictive value of p16 methylation diagnostic reagents in the early diagnosis of oral cancer, the investigators carried out the prospective multi-center double-blind cohort study.

Methods:180 patients with histologically confirmed mild or moderate OED were included in the present study. The investigators using p16 methylation diagnostic reagents to analysis of the p16 methylation status in these patients. Building two follow-up queue by p16-methylated and p16-unmethylated. The Statistical analysis used SAS6.12 software. All P-values were two-sided. P\<0.05 was considered to test for statistical significance difference.

Eligibility Criteria:
Inclusion Criteria:

* Histopathological diagnosis of oral lesions meet the epithelial diagnostic criteria for mild to moderate grade OED
* No local area stimulate by residual root and crown, sharp cusp, poor restoration and biting cheek or lips
* Without the OCE treatment history by laser , radiation or chemical
* Be able to Sign the informed consent

Exclusion Criteria:

* Histopathological diagnosis of oral lesions do not meet the epithelium of mild to moderate dysplasia diagnostic criteria; histological diagnosis of severe grade OED or malignant disease
* Pregnancy or breast-feeding women
* Serious heart, lung, liver , kidney and other systemic diseases
* local area stimulate by residual root and crown, sharp cusp, poor restoration and biting cheek or lips
* OED treatment history by LASER, radiotherapy, or chemotherapy
* Tumor and psychiatric patients
* Patients are unable to cooperate
Evaluation of Longterm Outcome of New York Heart Association Class III Heart Failure Patients Receiving Telemonitoring Using a Pulmonary Artery Pressure Sensor System (CardioMEMS)

Invasive hemodynamic monitoring in advanced heart failure patients is a relative new option. In order to investigate the impact of remote telemonitoring of pulmonary artery pressures on mortality and morbidity in a routine clinical setting in Germany, the investigators initiated this multicenbtric registry.

All patients who receive invasive hemodynamic monitoring using a pulmonary artery pressure sensor (CardioMEMS device) are offered participation in the registry. Routine heart-failure parameters, lab values, medication and QoL as obtained on the regular outpatients visits in the department are entered into a registry-specific database.

The investigators plan to asses the impact of telemonitoring on mortality, morbidity and QoL as well as on Guideline-recommended heart failure medication. In addition, it is planned to quantify the input in person time for telemonitoring.

Eligibility Criteria:
Inclusion Criteria:

* Implantation of CardioMEMS successful
* Telemonitoring according to the SOP of the Frankfurt Heart Failure Center (Goethe University)

Exclusion Criteria:

* Unwillingness to participate in the registry
A Comparison of the TIMI, GRACE and HEART Scores

Various elements of patient history are checked and entered in the admission Case Recor Form (CRF). Three risk scores are calculated out of these elements, combined with physical examination, laboratory values and ECG-findings.

The primary aim is to assess the positive and negative predictive values for a cardiovascular event of the three risk scores for chest pain patients.

Secondary aim is to assess the sensitivity and specificity of various elements in the patient history for an acute coronary syndrome.

This is a prospective, observational study in patients admitted to the emergency room for chest pain. All patients are checked by the resident in charge immediately on admission, before any lab values are known, by means of an admission Case Report Form (CRF), consisting of classical elements of patient history, risk factors, medication and physical examination. This CRF is filled out immediately by the resident. No additional effort will be asked of the patients.

Patient data during a follow up of at least 6 weeks are gathered from hospital charts.

The predictive value of the three scoring systems: HEART (History, ECG, Age, Risk factors, Troponin), TIMI (Thrombolysis in Myocardial Infarction) and GRACE (Global Registry of Acute Coronary Events) for both the discharge diagnosis and the occurrence of Major Adverse Cardiovascular Events (MACE) is calculated.

The primary hypothesis of the study is that the HEART score is a significantly better predictor than the TIMI and/or GRACE score for cardiovascular events during a six week period following admission to the emergency room.

Eligibility Criteria:
Inclusion Criteria:

* any patient visiting the cardiology emergency room due to chest pain

Exclusion Criteria:

* chest pain clearly due to rhythm disturbances or acute heart failure
* concomitant non cardiac disease with expected fatal outcome within 1 year
Continued Use of Effective Contraception After Use of Emergency Contraception

Women using an emergency contraceptive method must use back up protection for 1-2 weeks depending on method. The Copper-IUD is the most effective emergency contraceptive method. The investigators wish to explore if women choosing the Cooper IUD have a higher frequency of use of an effective contraceptive method 3 months and 6 months after the use of an emergency contraceptive method than women who choose to use the emergency contraceptive pill EllaOne (ulipristal acetate).


Eligibility Criteria:
Inclusion Criteria:

* women over 18 years
* eligible for all emergency contraception

Exclusion Criteria:

* previous conisation
* known stenosis of the cervix
* signs of ongoing genital infection
* known uterine anomaly
* Known bleeding disorder
Evaluation of the Impact of Chemotherapy on Body Odor in Adolescents and Young Adults in Oncology

The appearance of unpleasant body odors in adolescent Young adult (aya) wille be evaluated undergoing chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 15 and 25 years;
* New patients treated at the Curie Institute and hospitalized in the AJA oncology department;
* Patient undergoing chemotherapy administered intravenously;
* Solid tumors.

Exclusion Criteria:

* Patient undergoing oral chemotherapy;
* Persons deprived of their liberty or under guardianship (including guardianship);
* Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
Neurological Outcome of VLBW Infants With Early Hypotension

Comparison of short and long term neurological outcome of VLBW infants with and without early onset hypotension required intervention. The cohort includes all VLBW infants born in our institution between January 1997 and December 2000.


Eligibility Criteria:
Inclusion Criteria:

-VLBW infants born at the Sheba Medical Center between January 1997 and December 2000

Exclusion Criteria:

- none
Inflammatory Parameters as Predictive Factors for Complicated Appendicitis

Acute appendicitis is a major cause of acute abdomen. Although its diagnosis is clinical, it is often supported by complementary diagnostic tests. Sometimes, delay in diagnosis can lead to worsening of the clinical picture, resulting in a complicated acute appendicitis. Some series have studied some clinical and analytical parameters as possible predictors of complicated acute appendicitis.

A retrospective analysis of patients admitted for acute appendicitis and undergoing appendectomy between January 2014 and December 2017 was performed in order to assess the possible existence of preoperative analytical predictive factors for complicated acute appendicitis (such as leukocytosis, C-reactive protein and ratio between neutrophils and lymphocytes).


Eligibility Criteria:
Inclusion Criteria:

* all patients admitted for acute appendicitis

Exclusion Criteria:

* excluded if no existence of dosing of all the inflammatory parameters cited above
Electrically Assisted Movement Therapy

The purpose of this study is to determine whether intensive, focused training of the affected upper extremity after stroke results in long-term functional gains in moderately-to-severely paralyzed patients, more than 6 months after their vascular accident. During the course of therapy, user's attempts to move and complete exercises are assisted by neuromuscular electrical stimulation.

This pilot study quantifies functional gains induced by the Electrically Assisted Movement Therapy (EAMT), an extension of Constraint-Induced Movement Therapy to moderately-to-severely paralyzed patients in their stable plateau phase of recovery. During EAMT, patients can assist affected upper limb movements through functional electrical stimulation. Initially, patients are divided in two groups. One of the groups receives EAMT, the other receives the best possible physical and occupational therapy. Therapy consists in 40 sessions of 45 minutes twice per day over five weeks, including a one-week therapy break. After 20 sessions, group allocation is crossed-over, and patients don't receive any therapy for one week.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of one, first ever stroke (both ischemic or hemorrhagic) verified by brain imaging (MRI or CT);
* Chronic impairment after stroke (minimum 6 months);
* No contraindications to MRI;
* No contraindications to electrical stimulation;

Exclusion Criteria:

* Unstable recovery stage (difference between two examinations \> 1 FMA-UE point);
* Mild impairment of the upper extremity (FMA-UE \>= 21);
* Excessive spasticity of the affected arm (modified Ashworth Scale \> 2);
Full Digital Fabricated Ocular Prosthesis Versus Conventional Fabricated Technique

Different techniques of fabricating conventional custom-made ocular prosthesis were described. Traditional methods of custom fabricated ocular prosthesis had some limitations and take a long time, facial scanning and computed tomography will facilitate the full digital ocular prosthesis fabrication. Full digital ocular prosthesis is an innovated new technique to produce more accurate \& more esthetic ocular prosthesis with less time consumed, however very few articles are available comparing between the full digital technique \& the conventional one in manufacturing ocular prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* Have enough ocular bed to accommodate the ocular prosthesis.
* At least 3 months after surgery to allow complete healing of the socket.

Exclusion Criteria:

* Patients under steroid therapy or those under radio or chemotherapy.
* Patients having eye lid deformity.
* History of psychological disorder.
* systemic disease.
* eye infection.