cyrilzakka/clinical-trials huggingface dataset:
Active Release Technique and Graston Technique in Patients With Lateral Epicondylitis

This study will be a randomized control trial and will be conducted in Pakistan Railway Hospital Rawalpindi. A sample of 36 participants will be taken. Patients will be divided into two groups by sealed envelop method. Patients in group A will receive Active Release Technique along with conventional therapy while Patients in group B will receive instrument assisted soft tissue mobilization along with conventional therapy. The study includes intervention protocol of 4 weeks. The sessions will be given 3 times a week for 4 weeks. The outcome measures Numeric pain rating scale(NPRS), Hand Dynamometer and Patient-Rated Tennis Elbow Evaluation (PRTEE) will be measured at baseline and at the end of 4th week. Data will be analyzed by SPSS 25

Lateral epicondylitis is an injury caused by overusing the elbow. It is characterized by tenderness and pain over the lateral epicondyle of the elbow. It is not exactly a condition involving inflammation rather a chronic degeneration of the tendon. The major symptom of lateral epicondylitis is presentation or complaint of sharp pain at the lateral side of the elbow with swelling

Eligibility Criteria:
Inclusion Criteria:

* Chronic lateral epicondylitis, complaints for at least 3 months or more
* Pain intensity level between 3 to 6 on 0-10 point numerical pain rating scale

Exclusion Criteria:

* Acute/ sub-acute lateral epicondylitis
* Any cervical spine or any other upper limb dysfunction
* Any other neurological disease, cardiovascular disease, osteoporosis
* Bilateral complaints
Further Study of AFGen1 Clinical Performance

AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish further evidence for the clinical performance of AFGen1 on human participants.

The primary purpose of this study is to demonstrate the ECG signal acquired by the AFGen1 device is of adequate quality and is suitable to support its intended use for the detection of Afib. This will be evaluated by comparing the ECG data acquired by AFGen1 to that acquired by an FDA cleared 12-lead ECG device using a Bland-Altman analysis of the R-R intervals and R amplitude measurements and Eigenvector magnitudes derived from principal component analyses of simultaneously captured waveforms measured by both devices by both devices. The ECG waveforms from both devices will also be adjudicated by 2 independent cardiologists. The study will also seek to demonstrate that there is no degradation in the quality of the ECG signal it acquires when the device is placed in an anticipated misplacement position to that directed by the instructions for use of the device. Finally the study will seek to confirm the adhesive performance of the device is appropriate to support its intended use per the requirements of sections 4.4 and 5.4 of ANSI AAMI EC12-1 . Another purpose of the study is to collect extended 5 minute ECG recordings by the subject periodically triggering the device while wearing the device for 7 (+3) days. This data will be used for product development purposes.

Eligibility Criteria:
Inclusion Criteria:

1. 18+ willing to sign the consent form

Exclusion Criteria:

1. Implanted pacemakers
2. Implanted cardioverter defibrillators
3. Implanted cardiac resynchronization devices
4. Potential life-threatening arrythmias
5. Physical or mental health conditions that would prevent the person from being able to follow instructions regarding participation in the study
6. Open wounds, abraded or irritated skin at the application site
7. Planned to undergo a MRI during the course of the study duration
8. Known or suspected to be pregnant
9. Student or employee of TriVirum
Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters

Regional tissue oxygenation (rStO2) can be monitored by near infrared spectroscopy. The commercial devices FORE-SIGHT (CASMED) and INVOS (COVIDIEN) will be used simultaneously to test for their relative sensitivity for low oxygen levels just after birth on term infants born by elective cesarean section. Reproducibility will be examined by replacements of the sensors six times the next day when the infant is stable and quiet. Neonatal sensors will be used.


Eligibility Criteria:
Inclusion Criteria:

* Term infants (age more than 37 weeks of gestation)
* Elective cesarean section after an uncomplicated pregnancy

Exclusion criteria:

* Thick hair that makes good measurements difficult/impossible
* Obvious malformations or syndrome
* Complications in relation to the cesarean section
* Depression after birth (APGAR \< 8 after 1 minute)
Digital Heath Integration With Neuromodulation Therapies on Diabetic Neuropathy

This study will be carried out on 60 patients both gender male and female with diabetic neuropathy with age55-65 years. The patients will be selected from Elmahmoudia hospital .patients will be randomly assigned to two groups.

Experimental Group:

This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive TENS and NMES for 30 minutes 3 days per week,for 10 weeks with medical treatment.

Control Group:

This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive placebo TENS and NMES for 30-min sessions, 3 days per week, for 10 weeks with medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* 1. Diagnosis of diabetes based on World Health Organization (WHO) with ages from 55to 65years 2. BMI\> 25kg/m2 3. Clinically diagnosed with diabetic neuropathy. 4. All patients are taking oral hypoglycemic drugs with controlled diabetes mellitus.

  5. Willingness to comply with the study procedures and interventions. 6. Ability to provide informed consent. 7. presenting with Distal symmetric polyneuropathy (DSPN) based on a score of ≥7 on the validated Michigan Neuropathy Screening Instrument (MNSI) questionnaire.

  8. exhibiting moderately controlled blood pressure

Exclusion Criteria:

* 1. Presence of other significant neurological or musculoskeletal disorders that may confound the assessment of outcomes.

  2. Severe cognitive impairment or inability to provide informed consent. 3. Any recent surgical procedures or major medical events that could affect the study outcomes.

  4. Fracture. 5. Heart Failure. 6. Uncooperative patients. 7. Anemic patient. 8. Patients with liver diseases. 9. Smokers Patients. 10. Any cardiac pacemaker, automatic implantable cardioverter defibrillator (AICD), or other implanted electrical device 11. An existing deep vein thrombosis (DVT) 12. Any metal implants 13. Current foot ulceration or other lower limb skin ulcers 14. Any other cause of neuropathy
Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding

The purpose of this study is to test whether prophylactic application of haemostatic gel will reduce the rate of clinically significant bleeding requiring intervention (such as blood transfusion, admission to hospital, other blood products) following endoscopic resection of advanced duodenal neoplasia compared to standard therapy.

This is a post-marketing follow-up study of a CE marked medical device, controlled, comparative, randomized, multicentre, international single-blind.

The main objective is to evaluate the efficacy and safety of PuraStat in duodenal endoscopic mucosal resection or ampullectomy.

This study will be carried out in France in 3 investigative centers. The duration of patient participation in the study is approximately 37 days depending on the time between the selection and the endoscopic intervention.

Eligibility Criteria:
Inclusion Criteria:

Ampullary lesions

* Single ampullary lesion ≥ 10mm
* Resection via hot ampullectomy, injection/Endoscopic mucosal resection of adjacent lateral spreading component Duodenal Lesions
* ≤ 2 lesions
* Lesion ≥15mm
* Resection via hot Endoscopic mucosal resection
* Morphology: 0-Is, 0-IIa/b/c or combination, submucosal lesions

Exclusion Criteria:

* Inability to provide informed consent (including people with cognitive impairment);
* Pregnant or breastfeeding women;
* Allergy to PuraStat®;
* "Cold" mucosal endoscopic resection;
* Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
* Participating patient, or in a period of exclusion from another clinical trial;
* Patient not benefiting from a social security scheme.
Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation

The purpose of this study is to determine which of 4 lead positions is most effective for pacemaker patients with Sick Sinus Syndrome in order to avoid development of atrial fibrillation.

The incidence of Atrial Fibrillation (AF) in Sick Sinus Syndrome patients treated with pacing is quite high. As AF can cause dizziness, fatigue, thromboembolism and ischemic stroke it is clinically relevant. Due to earlier publications pacing modes and lead placement seem to influence the incidence of AF. In this study the incidence of AF will be compared between 4 different atrial lead positions:

1. Free atrial wall
2. right atrial appendage
3. coronary sinus-os
4. Dual site right atrial pacing: b) plus c).

The following primary parameters will be evaluated during the study period of 2 years after implantation:

1. Amounts of AF episodes with a duration of \> 48 hours
2. Amounts of AF episodes with a duration of \> 30 minutes
3. Consultations of physicians due to AF Secondarily, AF burden, Incidence of AF in total, Quality of Life, implant duration and complications will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Sick Sinus Syndrome
* Symptomatic sinus bradycardia
* Symptomatic SA block
* Bradycardia-Tachycardia-Syndrom
* Binodal diseases, Sinus Node Syndrome and high degree AV-Block
* In case of antiarrhythmic drug therapy: patient must be on a stable dose for at least 3 months before enrollment

Exclusion Criteria:

* Permanent atrial tachycardia that cannot be transferred into sinus rhythm by drugs or electric cardioversion
* Decompensated heart failure
* Dilatative cardiomyopathy with an ejection fraction \< 35%
* Hypertrophic obstructive cardiomyopathy
* Symptomatic hypo- or hyperthyreosis
* Myocardial infarction less than 6 months ago
* Planned cardiac surgery intervention
* Pregnant woman
* Patients under 18 years of age
* Patients involved in other studies
* Patients, already implanted with other (cardiac) leads
* Patients with reduced expectancy of life due to other diseases
* Patients who are not able to agree in participation of the study
* Patients, who cannot attend follow-up visits due to their place of residence
Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy

The objectives of the study are to evaluate the efficacy (primary endpoint: overall survival), safety (secondary endpoint) and the medico-economic impact (secondary endpoint) of nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid in clinical practice

Nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid was shown to be effective after gemcitabine-based treatment in patients with metastatic pancreatic adenocarcinoma in the phase III NAPOLI-1 randomized trial.

Nanoliposomal irinotecan is authorized in combination with 5-fluorouracil (5-FU) and leucovorin (LV), as it has shown an improvement in overall survival (median +1.9 months, HR = 0.67) compared to 5-FU/LV alone, without degradation of quality-of-life scales.

However, patients included in clinical trials regularly differ from patients in routine practice, and a real-life study is fundamental in this poor prognosis situation where quality of life preservation is paramount

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* histological or cytological confirmation of pancreatic ductal adenocarcinoma
* measurable lesion(s)
* progression after gemcitabine-based treatment administered in a neoadjuvant, adjuvant protocol (only if remote metastases developed within 6 months of the end of adjuvant treatment), locally advanced, or metastatic phase. They may have already received irinotecan and/or fluorouracil.
* Performance Status (PS) 0 or 1
* Oral consent
* Health insurance

Exclusion Criteria:

* symptomatic brain metastases (cerebral edema, corticosteroids, progressive disease)
* thromboembolic events within six months of inclusion;
* Class III or IV congestive heart failure, ventricular arrhythmia, uncontrolled hypertension.
* Patient under legal protection
* Hypersensitivity to irinotecan
* Breast feeding
Survey of Satisfaction on Traditional Chinese Medicine Jing-Guan-Fang (JGF) for COVID-19 Prevention

the retrospective observation study, the first line to care CAVID-19

The satisfaction of using nature herbal medicine for frontline medical staffs to prevent COVID-19: a retrospective clinical study.

The medical frontline staffs have the high risk to be infected during working. The stress and load were acuminated, especially when they got the similar symptoms as COVID-19. NHM has been used to early prevention for thousands of years9-12. It was well accept to take NHM for early prevention in many Asia-Pacific countries. Although many NHM remedies of COVID-19 treatment or prevention were reported, but the related study were lacking. To understand the pressure and the satisfaction of frontline medical staffs after taking JGF for early prevention we conducted this retrospective clinical study to explore the relationship in different groups.

Eligibility Criteria:
Inclusion Criteria:

* The person first-line medical staff in hospital
* the inspection personnel in airport
* self-quarantine at home.
* self-quarantine at office.

Exclusion Criteria:

* no willing to participate
* allergy to herbal medicine
* severe illness evaluated by physician
Effectiveness and Safety of SMART [Spastic Muscle Palpation by Anatomic Landscape for BoNT-A (Botulinumtoxin-A) Injection to Reduce Muscle Tone] BoNT-A Therapy With Dysport® in Patients With Post-stroke Chronic Upper Limb Spasticity (ULS) in Real-life Setting.

The purpose of this study is to collect data for Dysport® SMART BoNT-A therapy usage in an office-based setting in post-stroke participants with chronic (\> 6 months) focal Upper Limb Spasticity who have been under stable oral antispastics treatment or patients with no current anti-spasticity treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥18 years with the capacity to consent.
* Subjects with a post-stroke medium to severe focal upper limb spasticity for at least 6 months. Medium to severe focal upper limb spasticity is defined as MAS ≥2 in the PTMG and DAS ≥2 in the PTT.
* Cohort according to SMART guidelines. The SMART injection concept is designed to be used only in patients suffering from simple patterns ("easy to diagnose spasticity pattern") of adult ULS, where Abobotulinumtoxin-A (AboBoNT-A) (Dysport®) injection can be simplified, by recognizing common spasticity patterns and key muscles for injection, identifying those muscles by palpation, and appropriate injection points of the suggested muscles using anatomic landmarks.
* Subjects with treatment goals as reduction of pain, reduction of muscle tone, improvement of care (hygiene/dressing) and/or improvement of passive motion.
* Subjects with the intention to be treated with Dysport® according to the current local Summary of Product Characteristics (SmPC) (Germany) and injection according to SMART must be taken prior to the entry in the study.
* Physiotherapy should remain unchanged within 4 weeks before study start.

Exclusion Criteria:

* Patients treated with intrathecal Baclofen or BoNT-A within the last 6 months
* If treated with oral spasticity medication, change of oral spasticity medication within the last 4 weeks
* Patients with active hand functions or patients with treatment goals of active functions.
* Patients with any contraindication for Dysport® according to SmPC.
* Patients in whom SMART therapy is not appropriate (e.g. spasticity pattern other than specified in SMART guidelines).
* Participation in an interventional trial at the same time and/or within 3 months before baseline.
* Diagnosed contracture/contracted muscle.
Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery

The purpose of this study is to assess the association of genetic polymorphism such as the Brain-derived Neurotrophic factor (BDNF), in neurogenic dysphagia in those with brain lesion.

Neurogenic dysphagia attributable to acquired brain lesions, such as after stroke and after traumatic brain injury, are one of leading causes of chronic disability world widely and it is expected to substantially increase over the next two decades. Among various sequalae, dysphagia can be observed in about 40% -60% of post-stroke patients and 20% -30% of them might suffer from recurrent aspiration pneumonia and may inhibit recovery and can even lead to death. Recovery after brain lesions can be explained by specific molecular events. It is proven that Genetic polymorphisms associated with impaired neural repair or plasticity might reduce recovery from stroke. Not only for the motor recovery, but genetic polymorphism is also crucial for the recovery of swallowing after stroke, however, only limited amount of studies are available. Therefore, it is urgent to determine whether the recovery of swallowing disorders after stroke is affected by the inherent polymorphism of the patient, whether the degree of recovery and brain plasticity associated with swallowing depend on the gene characteristics and polymorphism of the patient and whether recovery in swallowing parallel to the recovery observed in other functional areas (ie. hand recovery, truncal control recovery, ADL recovery).

Based on the results of this study, results will be expected to help provide genetically tailored diagnosis and prognostication according to the gene polymorphism of the patient. Optimized treatment of the patient is expected to contribute to prevention of respiratory complications and improve functional outcome related to swallowing after stroke.

Eligibility Criteria:
Inclusion Criteria

1. Patients who had been diagnosed with first ever brain lesions ( stroke and traumatic brain lessons) and referred to Department of Rehabilitation( in Bucheon St. Mary's Hospital and National Traffic Injury Rehabilitation Hospital)
2. Patients who were hospitalized for 30 days and were followed up at 3 months after the onset of brain lesions
3. Patients who agree to participate in the study or if the guardian or legal representative agrees only if the patient has difficulties in consenting or consenting to participate directly in the language disability.
4. In the case of a suspected feeding swallowing disorder in the patient, the patient should be confirmed by VFSS(Videofluoroscopic Swallwing Study) or FEES(Fiberoptic Endoscopic Evaluation of Swallowing)

Exclusion Criteria

1. Patients who do not meet the above criteria
2. Patients with difficulty in collecting blood for genetic testing
3. Patients who were not able to followed-up for 6 months(follow up loss patients)
4. Patients with long-term Parkinson's disease, Alzheimer's disease, Guillain-Barre syndrome, myasthenia gravis syndrome, etc.
The Minimum Effective Concentration of Lidocaine for Ultrasound-guided Axillary Block for Arterio-venous Fistula Creation Surgery

The arteriovenous fistula creation (AVF creation) surgery is essential among patients with end stage renal disease who require hemodialysis. The fistula usually locates at forearm, and is created by connecting artery and vein through surgery. Patients undergone hemodialysis through the fistula six weeks later if fistula becoming mature, which means patent vessel diameter and enough flow for hemodialysis. The primary failure rate of arteriovenous fistula creation is about 20% to 40% according to previous research data. Thrombosis is the most common cause of fistula failure, which require surgical intervention after arteriovenous fistula surgery.

Anesthetic technique influences surgical outcome of arteriovenous fistula. General anesthesia, regional anesthesia, and local anesthesia are both wide-used methods. Regional anesthesia with nerve block remains the most popular method for arteriovenous fistula creation. The vessel dilation effect of regional anesthesia helps not only dilatation of artery and vein, but also the fistula itself, and promotes the successful functional dialysis. Various type of nerve block are used as anesthetic method for AVF creation surgery.

People requiring hemodialysis usually have multiple underlying disease involving other major organ such as heart, lung, liver, and the endocrine system. They are more vulnerable to systemic intravenous anesthetic medication. The metabolic rate and pharmacodynamics of local anesthetic may also alter due to multiple systemic disease when compared with healthy adults. The optimal concentration of lidocaine for AVF creation when using axillary block has not yet been studied. This research is conducted for dosing response of different concentration of lidocaine when using axillary block for AVF creation surgery. We aim to investigate the optimal low effective concentration, the MEC90, which defined as 90% of patients can tolerate the operation at this concentration.


Eligibility Criteria:
Inclusion Criteria:

* ASA classification I to III
* Operation site : First time undergone surgery

Exclusion Criteria:

* ASA classification IV to V
* Previous operation at surgical site before
* Allergy to local anesthetics
* Infectious state of injection point
* Neuromuscular disease causing preoperative numbness or weakness of extremities
* History of vascular thromboembolism including stroke, pulmonary embolism
* Peripheral neuropathy
* Patient with psychiatric disease
* Coagulopathy, or patient taking anti-coagulant