cyrilzakka/clinical-trials huggingface dataset:
Combining Transcranial Direct Current Stimulation and Core Stability Exercise on Trunk in Stroke Patient

To evaluate the effects of the combining transcranial direct current stimulation with core stability exercises on trunk performance in poststroke hemiparetic patients, the secondary outcome is to evaluate the balance and the functional performance of the participants.

This study will conduct to 60 male and female patients with post stroke hemiparesis with age ranged between 55 to 70 years, the patients will be categorized to two equal groups.

* Group A (study group): will receive simultaneously a combination of transcranial direct current stimulation combined with core stability exercise.
* Group B (control group): will receive core stability exercise. All patients will be assessed for trunk performance, balance, and functional performance before and after interventions.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be included if they are ≥ 55 years old of both sex, had a first-time right or left stroke within the preceding six months that damaged the cerebral cortex verified by (computed tomography or MRI report, neurological examination, and medical chart).
* Patients can stand and walk independently.
* Modified Ashworth Scale (MAS) of upper limb muscle ≤ 1+.
* All the patients received a conventional physiotherapy program in the acute stage and post-discharge from the hospital.
* None of the patients participated in any other study or placebo

Exclusion Criteria:

* Patients with neurological or orthopedic problems, paralysis neglect, behavioral abnormalities, dementia any shoulder dysfunction before or post-stroke (dislocation or subluxation), or those who using upper limb splints.
* Recurrent strokes or hemiparesis due to other neurological causes rather than stroke eg .(Brain tumor).
* Obesity (BMI ≥ 30 kg/m2).
Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants

The purpose of this study is to demonstrate the safety and efficacy of Nucleus cochlear implant programming via telecommunication.

Cochlear implant recipients will undergo remapping at a location remote from their audiologist via telehealth. Audiologists will use an internet meeting platform to remotely log into the subject's computer and control the programming software. Remote programming sessions will be completed both with and without the assistance of a trained facilitator, and speech understanding will be tested in between mapping sessions.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged greater than 12 years that are native English speakers and are capable of completing the study evaluation as deemed by their primary audiologist
* Unilateral or bilateral cochlear implant recipients of a CI24RE, CI422 or CI500 series implant who are in possession of a backup sound processor
* A minimum of 12 months' experience with a CP800 or CP900 series sound processor, and current MAP programmed within 12 months prior to Visit 1
* Willingness to participate in and to comply with all requirements of the protocol
* Able to demonstrate protocol competence as confirmed by primary audiologist

Exclusion Criteria:

* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations of remote service delivery
* Unwillingness or inability of the candidate to comply with all investigational requirements
* Additional handicaps that would prevent or restrict participation in the audiological evaluations
* Inability to demonstrate basic technological skills for simple computer-based tasks and device connecting after training by primary audiologist
Versius Paediatrics Study

This is prospective, multi-phase, single arm, multi-centre, multi-surgeon feasibility clinical trial to provide proof of concept and clinical evidence regarding the safety and efficacy of Versius (robotic surgery medical device) in Urological Procedures in Paediatric population. In alignment with IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework, this study will consist of 3 main phases to ensure proper procedure development while ensuring patients safety. Feasibility and safety will be assessed on an ongoing basis, and specifically after completion of the first 3 procedures, at a single site (Southampton/Lead), each conducted one week apart to allow the identification of unanticipated risks/adverse events. Once deemed safe, based on the results of the 3 cases enrolled in Phase I, 7 further cases would be completed, at the same site. Once the procedure is deemed safe according to safety data collected, the recruitment will proceed to full trial patient accrual, 140 additional cases from the 3 participating study sites.The study patient population is children and adolescents under the age of 18, which will be provided clinical care and follow-ups per standard of care and hospital's policy.


Eligibility Criteria:
Inclusion Criteria:

* Patients, male or female, (\<18 years old) for whom an appropriate legal representative provides written consent for participation
* Patient and disease factors deemed suitable for minimal access urological procedure
* Multidisciplinary team (MDT) decision to treat with surgery
* Patients under the care of the paediatric urology team in one of the participating centres

Exclusion Criteria:

* Patients ≥ 18 years old
* Appropriate legal representative unwilling to provide written consent
* Medical contraindication for general anaesthesia
* Medical contraindication for laparoscopic procedure
* Active pregnancy (in post-pubertal female patients)
* Morbid obesity (BMI ≥ 40 kg/m2)
* Patient participation in an interventional clinical study, that could impact primary objectives results
* Prior pelvic /abdominal radiotherapy treatment
* Subjects with other clinically significant unstable medical disorder, life-threatening disease, or anything else in the opinion of the Investigator which would contra-indicate a surgical procedure
Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions

A randomized control trial will provide the most reliable data to determine the role of prophylactic antibiotics to decrease the wound complication rate. The investigators plan to perform a pilot study to evaluate actual rates of wound complications and how long it takes to recruit 50 patients.


Eligibility Criteria:
Inclusion Criteria:

* All women, \>=18 undergoing vulvar surgery
* Biopsy proven benign or premalignant lesion requiring surgical management.
* Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery.
* Scheduled to undergo surgical management for their vulvar disease supervised by a faculty member within the Division of OBGYN at Washington University School of Medicine
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

* Women who are pregnant
* Women scheduled to undergo a radical vulvectomy
* Women scheduled to undergo a concomitant graft, flap or plastic surgery
* Women \<18 years of age
* History of prior vulvar radiation
* Inability to sign an informed consent form prior to registration on study
* Inability to understand spoken or written English
* Prisoner
Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol

This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of the reference products (simvastatin, ramipril, acetylsalicylic acid) Approximately 350 subjects will be screened, 266 randomized in order about 238 subjects to finish the study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged ≥18 and \<75 years.
* Previously untreated or not treated with fibrates during the last 6 weeks or with any other lipid lowering drug for the last 4 weeks.
* LDL-cholesterol ≥130 and ≤220 mg/dL.
* Systolic blood pressure ≥120 and \<160 mmHg and diastolic blood pressure ≥70 and \<100 mmHg.
* Provide written informed consent.

Exclusion Criteria:
Blood Purification Therapy With Dual-cannula in Jugular-femoral Venous

Acute kidney failure (AKI) is one of the most important causes of morbidity and mortality for critical ill patients. The use of blood purification treatment such as renal replacement therapy (CRRT) and plasma exchange has gradually developed into an effective treatment. However, the efficiency of blood purification may be affected by the recirculation of dual-lumen venous catheter for some special patients including patients with vena cava reflux disorder from massive occupations or ascites. For extreme cases like patients with vena cava disconnection or severe obstruction, the traditional blood purification treatment cannot work effectively. Thus, we used the dual-cannula in jugular-femoral venous blood purification therapy in the following two patients and found that it can improve the perfusion of systemic circulation and the prognosis of patients


Eligibility Criteria:
Inclusion Criteria:

* 1. patients requiring haemodilution therapy for various reasons (acute renal failure, acute liver failure, etc.)
* 2. presence of superior vena cava and/or inferior vena cava reflux disorders
* 3. age greater than 18 years

Exclusion Criteria:

* 1. Inability to establish suitable vascular access
* 2. Pregnant women
* 3. Not agreeing to active life support treatment
* 4. Severe active bleeding
Food Composition and Palatability

This study will investigate fat taste and if free fatty acids (FFA) in food function as a signal for fat content. FFA are quite unpleasant - the investigators want to measure if the concentration in different foods correlates with hedonic preference. FFA concentration from a variety of foods will be used to determine if people who have greater sensitivity for FFA find foods with higher FFA concentrations less acceptable. Further, this study with determine whether the relationship between fat taste and hedonic food preference is modified by sex and body mass index (BMI).


Eligibility Criteria:
Inclusion Criteria:

* Age 18-64
* Healthy
* Non-smoker

Exclusion Criteria:

* Food allergies
* Inability to detect and identify basic tastes
Acupressure in Hyperemesis Gravidarum

To examine the degree of nausea, vomiting between the acupressure and control group in women with hyperemesis gravidarum

A prospective RCT conducted at Department of Obst and Gynae, UKMMC. All pregnant women with a normal intrauterine pregnancy of ≤ 16 week gestation with hyperemesis gravidarum will be assessed by the medical officer/ specialist/ consultant in charge. Explanation regarding the research study will be given for patients who fulfill the inclusion and exclusion criteria. Patients who have understood the research study and consented will be recruited as subjects for the study.

Eligibility Criteria:
Inclusion Criteria:

1. Onset of vomiting before 16 weeks
2. Vomiting at least 2 times per day
3. Ketonuria on admission
4. Mid stream urine specimen that did not indicate infection

Exclusion Criteria:

1. Non viable pregnancy
2. Molar pregnancy
3. Overt clinical features of thyrotoxicosis
4. Known case of medical illness that associated with nausea and vomiting
5. Patient refusal or patients who are not able to give consent
Left Ventricular Stiffness vs. Fibrosis Quantification by T1 Mapping in Heart Failure With Preserved Ejection Fraction

StiffMAP-HFpEF trial is an investigator initiated, observational, single-center study that will evaluate whether fibrosis quantification by cardiac MRI correlates with left and right ventricular stiffness derived from pressure-volume analysis, aiming to clarify if cardiac MRI is a valid, non-invasive method to assess diastolic function in patients with Heart Failure with preserved ejection fraction.

Heart Failure with preserved ejection fraction (HFpEF) and diastolic dysfunction is a growing medical challenge. To date almost every second patient with heart failure has a preserved ejection fraction and recent data show that outcomes in these patients are as bad as in those with reduced ejection fraction. In clinical routine the diagnosis of HFpEF is complicated by indirect assessment of diastolic function. Mechanistically the diastolic dysfunction is among others believed to be caused by the development of diffuse myocardial fibrosis with an increase of extracellular matrix.

Direct assessment of the intrinsic diastolic function and stiffness of the ventricle can be obtained by pressure-volume-curve tracings through a conductance catheter. Although this offers the benefit of assessing load-dependent and load-independent parameters of diastolic function as well as information on contractility and ventricular-arterial coupling, the use of this technique is limited by its invasiveness in daily care.

Newer MRI techniques have made it possible to quantify not only local fibrosis but also diffuse fibrosis (i.e. T1-Mapping) and determine extracellular volumes.

Moreover, the role of right ventricular function is in HFpEF is not well defined.

Aim of the current study is therefore to evaluate the role of MRI in assessing cardiac fibrosis in the context of impaired LV diastolic function in HFpEF patients, as well as to evaluate the role of systolic and diastolic right ventricular functional impairment in this patient cohort.

Eligibility Criteria:
Inclusion Criteria:

* LV-EF \> 50%
* Indication for invasive cardiac catheterization

Exclusion Criteria:

* know CAD or CAD in Angiography (stenoses \> 50%)
* acute coronary syndromes
* Cerebral ischemia within the last year
* contraindications for MRI
* more than mild valvular disease
* Constrictive pericarditis, restrictive Cardiomyopathy, pericardial effusion
* pregnancy
* enrolment in other study
Dysphagia Following Anterior Cervical Spine Surgery; Steroid vs Saline

This prospective, randomized, double blind, controlled study evaluates the effect of perioperative IV steroids versus saline on swallowing after anterior cervical spine surgery.

This investigation is a prospective, randomized, double-blind, controlled trial testing peri-operative steroids versus saline and the effect on swallowing after anterior cervical spine surgery. Swallowing symptoms will be measured using the patient reported Bazaz (Bazaz) scale and the Dysphagia Short Questionnaire (DSQ). Swallowing data will be obtained pre-operatively, one day and two days post-operatively and then one week, two weeks, four weeks, three months, six months, and one year post-operatively. Patient clinical outcomes will be captured using web-based progress reports. Patients will complete the Quality of Life (QoL-12), Neck Disability Index (NDI), and Visual Analog Scale (VAS) questionnaires electronically pre-operatively and at one year post-operatively. This outcome data will help us analyze the swallowing function or symptoms with the overall clinical course of the patients enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* Elective anterior approach to subaxial cervical spine (C3 - T1);
* ages 18-80

Exclusion Criteria:

* Traumatic or tumor etiologies
* undergoing anterior-posterior operations
* neoplastic, or infectious conditions requiring surgery
* a history of previous anterior cervical spine surgery
* any patient requiring a halo vest
* patients on chronic steroids
* patients remaining intubated post-operatively (please see more under risks below)
* less than 18 years of age
* pregnant women
* no phone
Ultra-high-frequency ECG for Prediction of Left Ventricular Remodeling

The main goal of the project is to prove that ultra-high-frequency ECG (UHF-ECG) can be used as a diagnostic tool that allows the prediction of patients susceptible to the negative effect of right ventricular myocardial pacing. The prediction will be based on the assessment of electrical dyssynchrony and local depolarization durations of left ventricular depolarization emerging during right ventricular pacing. If proved to be valid in left ventricular negative remodeling prediction, UHF-ECG-derived parameters of ventricular dyssynchrony could be used as markers allowing a lead placement optimization during an implant procedure. This information can help the operator to identify patients with the urgent need for physiological pacing (HB or LBBp) and patients in which a right ventricular myocardial pacing is sufficient and will not lead to the development of the negative left ventricular remodeling.


Eligibility Criteria:
Inclusion Criteria:

1. expectation of permanent right ventricular pacing with atrio-ventricular delay set to 150/180 ms (130/160 resp.) for sensed/paced atrial events during a follow-up,
2. a good quality of images during echocardiography,
3. willingness to attend clinical check-ups in the implanting center for at least two years.
4. life expectancy of at least 2 years

Exclusion Criteria:

1. planned cardiac surgery or transcatheter aortic valve implantation
2. hypertrophic cardiomyopathy
3. an indication for implantable cardioverter-defibrillator, biventricular implantable cardioverter-defibrillator, or biventricular pacemaker
4. active myocarditis
5. cardiac surgery or coronary revascularization in the last ten days
6. persistent/permanent atrial fibrillation during randomization
7. severe aortic stenosis
8. mitral valvular disease with an indication to intervention.
Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS)

The goal of this clinical trial is to compare spray cryotherapy plus balloon dilatation versus current standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in patients with benign airway stenosis with simple stenosis. The main question\[s\] investigators aim to answer are:

1. What is the need for reintervention and time to reintervention in participants with benign airway stenosis with simple stenosis who receive spray cryotherapy plus balloon dilatation versus standard of care alone?
2. To evaluate patient experience, physiological, anatomical changes, health care utilization and safety of the SCT plus balloon dilatation versus standard of care alone.

Researchers will compare spray cryotherapy plus balloon dilatation versus current standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in patients with benign airway stenosis with simple stenosis to see if it reduces the need of re intervention.

Participants will surgery and receive one of the two interventions.

Investigators propose a single center, single-blinded (patient), randomized 1:1 trial comparing SCT plus Balloon dilatation (experimental group) vs SoC alone (control group). Investigators aim to recruit 50 patients.

Study will span 2-year duration with 1 year recruitment. Follow up at 6 weeks, 3 months, 6 months, 12 months. The patient's airway will be either a laryngeal mask airway or a rigid bronchoscopy for passive venting and gas egress.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with symptomatic, benign, simple stenosis of the trachea and/or subglottic space.
* 2. Stenotic airway of diameter \< 1cm.

Exclusion Criteria:

1. Complex stenosis, cartilage involvement (malacia or fracture).
2. Patients with giant bullae (\> a third of hemithorax) or bullae \>3cm.
3. Concurrent tracheoesophageal fistula, active tracheal malignancy.
4. Presence of concomitant upper airway obstruction.
5. Pregnancy
Examining the Impact of Mindfulness on Patients' Experience of Osteopathic Manipulation

This is a single site, two-arm, parallel group pilot randomized controlled trial examining the effect of coupling a brief mindfulness-based intervention with an osteopathic manipulation session for pain patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for OMT at the Huntsman Cancer Institute

Exclusion Criteria:

* Altered mental status due to delirium, psychosis, or medication sedation as determined by treating clinician.
Promo@Work Entrepreneurs

A randomized intervention study to promote work recovery and work ability among micro-entrepreneurs. The main aim is to investigate if the use of Recovery! -application results in better work recovery and work ability than no treatment for micro-entrepreneurs.

The plan of action of the study merges: 1) the contents that are based on the needs of the target population and evidence from research on work related and health behaviour enhancing work recovery, 2) theoretical framework for the counselling, 3) counselling methods including behaviour change techniques, and 4) tailoring the content and counselling according to trans theoretical change model and physical work demands. The intervention is delivered through native mobile application designed by using the abovementioned methodology.

Data are collected by repeated internet-based questionnaires (at baseline, 2 and 6 months from the beginning of the intervention) and from the use of mobile application. Furthermore, randomly selected persons in two groups (20-30 persons in each) are interviewed. Process evaluation is conducted to detect the mechanisms of change and to study why the program succeeded or failed.


Eligibility Criteria:
Inclusion Criteria:

* Finnish-speaking micro-entrepreneurs (those with enterprise of 1-9 employees),
* company is located in Finland.
* work full-time as entrepreneurs,
* understand Finnish,
* use an Android phone.

Exclusion Criteria:

* not full-time entrepreneurs
* on sick leave
* absent from work
Transcranial Magnetic Stimulation to Measure Cortical Excitability in Dravet Syndrome

Dravet syndrome (DS) is an epileptic encephalopathy caused by pathogenic variants in the SCN1A gene resulting in medically refractory epilepsy and psychomotor delays.

As a pilot study assessing for feasibility, the investigators aim to test whether alterations in cortical excitatory:inhibitory ratio can be reliably recorded. The investigators will utilize transcranial magnetic stimulation (TMS) metrics of cortical excitatory and inhibitory tone as an initial step towards translating findings from rodent genetic models of DS into disease-specific biomarkers and offer future measures of therapeutic target engagement in this patient population.

Participants will complete two visits, each consisting of a TMS session and an EEG session. Visits will be scheduled 4-8 weeks apart.

This is a single site study to be conducted at Boston Children's Hospital (BCH) investigating the neurophysiological biomarkers of epilepsy and developmental disability in children and young adults with Dravet Syndrome.

Mechanistically, the features of the DS phenotype are attributable to a loss of cortical inhibition. TMS is a non-invasive form of focal cortical stimulation in which an external powerful magnet induces an electrical field intracranially over the stimulated region that is used to interrogate or modulate states of cortical excitation or inhibition.

Accordingly, the investigators propose to test whether metrics of cortical excitability and inhibition can be obtained by transcranial magnetic stimulation (TMS) and EEG in patients with DS.

Eligibility Criteria:
Inclusion Criteria:

* Age: 6 months - 30 years
* Ability to obtain informed consent with the participant or legally authorized representative
* DS confirmed by pathogenic variant in SCN1A gene
* Medical history consistent with clinical phenotype of DS

Exclusion Criteria:

* Comorbid conditions such as a second genetic diagnosis which may confound interpretation.
* Current or planned participation in a clinical drug or device trial.
* Previous participation in a gene therapy or gene editing trial
* Allergy to adhesives used for surface EMG electrodes
* Contraindications to TMS (e.g. implanted devices for which there is no TMS safety data)