cyrilzakka/clinical-trials huggingface dataset:
Radiofrequency in Sacroiliac Arthropathy;Bipolar RF 6 Points Versus Monopolar RF at 6 and 3 Points

Expecting using bipolar RF at six points, in spite of potentially consuming more intraoperative time, to be more effective and long lasting in the management of pain resultant from chronic sacroiliac joint arthropathy than the other 2 techniques using the monopolar RF even if using six points.

A Prospective, single center, double blind, controlled randomized trial.

Sample Size:

Total of 60 patients divided into three groups:

Group 1: 20 patients will be receiving bipolar RF at six points. Group 2: 20 patients will be receiving monopolar RF at six points. Group 3: 20 patients will be receiving monopolar RF at three points.

Sampling technique:

Patients will be randomly divided in three groups. There will be a box with 60 closed envelopes, divided randomly in to three groups with 20 envelops in each group. On arrival to theatre one of the envelops will be opened and the assigned method will be applied.

Timeframe of the study:

6-12 months

Procedure:

After fulfilling inclusion criteria and apart from the exclusion criteria, patients will do either one of the three procedures according to the randomization. All patients will do the procedure under fluoroscopic guidance with use of Cosman RF generator G4TM, 20 gauge straight sharp cannula, 10 cm shaft, 10 mm tip and 10 cm electrodes (Cosman autoclavable CSK-TC10).

Group 1 ; Six RF needles will be put between the SIJ and the lateral aspects of the ipsilateral dorsal sacral foramina. After sensory and motor stimulation, bipolar lesion RF at 80oc for 90 sec will be applied between each successive pairs of needles.

Group 2; RF needle is inserted at six levels in the area between the SIJ and the lateral aspects of the ipsilateral dorsal sacral foramina. after sensory and motor stimulation, monopolar lesion RF at 80oc for 90 sec will be applied.

Group 3; RF needle is inserted at six levels in the upper , middle and lower part of the area between the SIJ and the lateral aspects of the ipsilateral dorsal sacral foramina. after sensory and motor stimulation, monopolar lesion RF at 80oc for 90 sec will be applied.

Patients will be evaluated by a specialized pain nurse after 2 weeks, one month, 3 months and 6 months for pain score using the visual analogue pain scale.

Overall patient satisfaction with pain relief will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* • Moderate to severe low back pain for more than six months with positive Patrick's and Yeoman's tests with tenderness over the SI joint.

  * Pain is not responding to the usual medical treatment.
  * More than 50 % pain relief after diagnostic injection with local anesthetic.

Exclusion Criteria:

* • Patient refusal to do the procedure or to share in the study

  * Focal Neurologic Signs.
  * significant anticoagulation e.g. clopedogril (low dose aspirin will be excluded)
  * Pregnancy, breast feeding or planning on becoming pregnant during the trial.
  * Infection at the intended injection site.
HEMI-STIM. tDCS and Intensive Therapies

Application of Transcranial Direct Current or placebo combined with Constraint Induced Movement Therapy (CIMT) and bimanual intensive therapy (BIT) in infantile hemiplegia (4-8 years). Before, after the treatment and 3 months after the treatment, the functionality of the affected upper limb will be assessed: Spontaneous use, alignment of the affected segment in movement, action of grasping and releasing an object with the wrist in a neutral position, extension and flexion and quality of life. CIMT will last 3 hours per day in a period of two weeks (10 days from M-F), and the transcranial direct current or placebo will be combined during the first 20 minutes of it. In addition, 45 minutes of BIT will be performed during the third week (3 days). The total time of the therapy will be 33 hours and 45 minutes. CIMT and BIT will have a playful and group performance model.

Objectives: To determine the efficacy of the combined application of transcranial direct current (tDCS) with a restraint-induced movement therapy program and bimanual therapy on quality of life, quality of movement and spontaneous use of the affected upper limb in children. with infantile hemiparesis.

Design: Randomized clinical trial with triple blind placebo control. Participants: 30 children between 4 and 8 years old diagnosed with infantile hemiparesis randomized into two groups.

Intervention: Program of 15 sessions (3 weeks) in which 20 minutes of cathodic tDCS (active or placebo) will be applied during the performance of 3 hours of restriction-induced movement therapy (CIMT) in the first two weeks and with 45 minutes of bimanual intensive therapy (TIB) in the third week. The effective duration of the intervention will be 33 hours and 45 minutes.

Variables: The outcome variables will be recorded before the intervention program, just after and three months after its completion.

Analysis: An intention-to-treat analysis will be performed. For the main result variables, a two-factor ANOVA (intervention-time) will be performed with a post-hoc analysis with Bonferroni correction.

Eligibility Criteria:
Inclusion Criteria:

* Children between 4 and 8 years old, with a diagnosis of congenital infantile hemiplegia, with a score between levels I and III of the manual ability classification system (MACS) and a level I-III of the gross motor function classification system will be included (GMFCS). In addition, children must have a preserved cognitive ability to understand the execution of structured activities

Exclusion Criteria:

* Having previously been treated with tDCS; Having been infiltrated with botulinum toxin 2 months prior to the intervention; Surgery of the upper limb the 6 months prior to the intervention; Pharmacologically uncontrolled epilepsy or having suffered epileptic seizures in the two years prior to the study (according to international recommendations for tDCS in children, Gillick et al., 2018); Contraindications of tDCS according to international recommendations. In addition, a withdrawal criterion will be non-attendance for more than 20% of the hours of the program.
Dietary Education Intervention Impact on Dietary Protein Intake in PD

This study is a prospective randomized controlled pilot trial/(a combined prospective and retrospective study). The investigators will use wechat intervening dietary protein intake in patients treated with peritoneal dialysis.

Malnutrition is highly prevalent in peritoneal dialysis (PD) patients, and protein malnutrition will adversely affect outcomes. The investigators develop a dietary education intervention for PD patients to improve fundamental food knowledge that will increase protein intake to target level of 1.2 g/kg of protein intake per day. In additional the dietary intervention will provide information about sodium, phosphorus, calcium intake. To more effectively deliver the intervention, the investigators explored a technology using social media in China called wechat. The purpose of this study is to test whether a dietary intervention can be more effective when delivered using wechat compared to a traditional patient education intervention delivered during routing clinical visits.

Eligibility Criteria:
Inclusion Criteria:

* 1. All patients followed at the PD center who successful completed training and have received treatment for at least 1 month.
* 2. The life expectancy will be more than one year.
* 3. All patients will provide written informed consent.

Exclusion Criteria:

* 1.the patients will be severe ill status and unlikely to survive for 12 months.
Study to Compare Pharmacokinetic Profiles of TRK-100STP in Japanese, Chinese, and South Korean Non-elderly Healthy Adult Males

A study to evaluate the pharmacokinetics and safety of TRK-100STP in Japanese, Chinese, and South Korean non-elderly healthy adult males.


Eligibility Criteria:
Inclusion Criteria:

* Body weight: =\<50.0 to 80.0\> kg
* BMI: =\<17.6 to 26.4\>
* Subjects whose condition an investigator/subinvestigator has confirmed to be healthy by the date of drug administration, based on the screening test results

Exclusion Criteria:

* Subjects who received an investigational drug within 120 days prior to the screening test in other clinical trials or post-marketing studies
* Subjects who had 400 mL whole blood drawing within 90 days prior to the screening test, who had 200 mL whole blood drawing within 30 days prior to the screening test, or had component blood drawing within 14 days prior to the screening test
* Subjects who has received or will receive any drug treatment including over the counter (OTC) drugs within 7 days prior to the day of confinement
* Subjects whose vital signs are out of the standard level in one of the following parameters at the time of the screening test or the day of confinement: blood pressure, pulse rate, body temperature, and 12-lead ECG
* Subjects who have had upper Gastro-Intestinal (GI) symptoms within 7 days prior to the day of confinement (1 day prior to the drug administration): nausea, vomiting, or stomachache
* Subjects who have complications or history of liver diseases: viral hepatitis or chronic bronchitis
* Subjects who have complications or history of Cardio Vascular (CV) diseases: chronic heart failure, angina, or arrythmia that needs treatment
* Subjects who have complications or history of respiratory diseases: severe bronchial asthma or chronic bronchitis. History of pediatric asthma is not included
* Subjects who have complications or history of respiratory diseases: severe peptic ulceration or gastro-esophageal reflux disease. History of appendicitis is not included
* Subjects who have complications or history of renal diseases: acute renal failure, glomerulonephritis, or interstitial nephritis. History of calculus is not included
* Subjects who have complications or history of cerebrovascular diseases including cerebral infarction
* Subjects who have complications or history of malignant tumors
* Subjects in whom the daily amount of alcohol or smoking is excessive
* Subjects who have received beraprost
Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom

This is a retrospective observational research study to describe the characteristics and real-world clinical outcomes of patients with chronic lymphocytic leukaemia receiving acalabrutinib in the United Kingdom (the EPIC study). Physicians treating chronic lymphocytic leukaemia patients with acalabrutinib, where the patients started treatment as part of the acalabrutinib Early Access Programme (EAP), will be invited to recruit patients. Clinical data will be extracted from the patients' clinical records in line with local laws. Data from this study will provide UK-specific real-world data on patients who were started on acalabrutinib as part of the UK acalabrutinib EAP.

1. Primary Objectives:

   a. To estimate real-world progression-free survival in patients with CLL who received acalabrutinib in the first-line.
2. Secondary Objectives:

   1. To estimate real-world overall survival in patients with CLL who received acalabrutinib in the first-line.
   2. To describe real-world response rate to acalabrutinib in patients with CLL who received acalabrutinib in the first-line.
   3. To describe the healthcare resource utilisation in patients with CLL who received acalabrutinib in the first-line.
   4. To describe post-progression treatment patterns in patients with CLL who progressed from first-line acalabrutinib.
   5. To describe real-world clinical progression free survival in patients with CLL who received acalabrutinib in the first-line and progressed during acalabrutinib treatment.
   6. To describe acalabrutinib treatment patterns in patients with CLL who received acalabrutinib in the first-line.
   7. To describe baseline clinical and demographic characteristics in patients with CLL who received acalabrutinib in the first-line.

Eligibility Criteria:
The study population will include treatment-naïve patients with chronic lymphocytic lymphoma (CLL)\* who meet the following inclusion criteria:

* Treatment-naïve CLL patients who were initiated on acalabrutinib as part of the UK Early Access Programme
* Received their first dose of acalabrutinib between 1 April 2020 and 1 April 2021
* Patients aged ≥18 years old

  * Note: patients later found to have small lymphocytic lymphoma (SLL) may also be included in the EAP.

Exclusion Criteria:

- None listed in study protocol
Prognostication of Recovery in Early Disorders of Consciousness Study

By collecting multimodal metrics (e.g., clinical factors, neuroimaging, and EEG) in the early phase of severe brain injury (i.e., during the acute hospitalization when a patient has impaired consciousness), and measuring the patients' recovery of consciousness, function, and quality of life in the late phase (at 6 months following the brain injury), we aim to construct an algorithm that synthesizes the results of these metrics to help predict recovery.

The primary aim of this research proposal is as follows: By collecting multimodal metrics (e.g., clinical factors, neuroimaging, and EEG) in the early phase of severe brain injury (i.e., during the acute hospitalization when a patient has impaired consciousness), and measuring the patients' recovery of consciousness, function, and quality of life in the late phase (at 3, 6, and 12 months following the brain injury), we aim to construct an algorithm that synthesizes the results of these metrics to help predict recovery.

There will also be secondary aims as follows:

1. To identify patient phenotypes with predictive significance, in order to revise our classification scheme for disorders of consciousness in a clinically meaningful and data driven manner.
2. To compare prognostic value between metrics.
3. To determine how the initial goals of care expressed in the acute setting (i.e., the expected quality of life associated with disability) compare to the actual quality of life in the chronic setting (i.e., the actual quality of life associated with disability).
4. To compare the prognostic value of metrics between different etiologies of brain injury.

Eligibility Criteria:
Inclusion Criteria:

* Acute brain injury (including ischemic stroke, intracranial hemorrhage, anoxic brain injury, traumatic brain injury, encephalitis)
* Inability to follow commands, speak intelligibly, or communicate (i.e., diagnosis of coma, vegetative state, or minimally conscious state minus) due to the underlying brain injury and within 28 days of the brain injury
* Age 18 or greater.

Exclusion Criteria:

* Subjects will be excluded if they do not speak English (given the reliance on verbal questionnaires conducted in English) or if they regain the ability to follow commands, speak intelligibly or communicate (i.e., improves to minimally conscious state plus or greater) before they undergo MRI or EEG.
Evaluate the Relevance of the Use of Peripheral Venous Blood Gases for the Care of Patients in the S.A.U.V (Vital Emergency Rooms) of the CHU de Caen

concordance between the lactate values on peripheral venous and arterial blood gases in all patients receiving an arterial sample on their arrival in the S.A.U.V.


Eligibility Criteria:
Inclusion Criteria:

* one of this condition in emergency unit :

  1. acute respiratory distress
  2. a suspicion of an acid-base disorder
  3. a state of shock
  4. Pathologies requiring monitoring of the respiratory system
  5. Patient under NIV
  6. Poisoning
  7. Coma with a Glasgow score \< or equal to 8

Exclusion Criteria:

* Patient presenting another pathology supported in SAUV not requiring the realization of arterial blood gases
* Patient aged \< 18 years
* Pregnant or breastfeeding woman
Radiotherapy vs Neck Dissection for Clinical T1/2N0 Supraglottic Cancer

Supraglottic cancer is a main type of laryngeal carcinoma, which is one of the most common head and neck tumors. Cervical nodal metastasis is an important prognostic factor in supraglottic cancer. Current management, following the US National Comprehensive Cancer Network guidelines for T1-2, N0 supraglottic cancer (NCCN 2017), is either definitive radiotherapy or primary surgery with or without neck dissection. The optimal neck treatments strategy remains unclear in clinical settings owing to the limitation of a small number of retrospective studies and a lack of prospective trials. The investigators conducted a prospective, randomised trial to compare radiotherapy with neck dissection.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent document
2. Age≥ 18 and≤ 75 years
3. Histological/ cytological/ Imaging examination proven supraglottic squamous-cell carcinoma in preoperative assessment
4. Cervical node negative according to the imaging characteristics and the physical examination
5. KPS≥ 70
6. Normal bone marrow reserve function and normal liver, kidney function
7. Expected survival period≥ 12 months

Exclusion Criteria:

1. Inability to provide an informed consent
2. Proved distant metastasis
3. Clinical stage 3-4
4. The patient has received prior surgery or radiotherapy (except for biopsy )
5. The patient has received chemotherapy(including targeted therapies) or immunotherapy
6. Prior malignancy within the previous 5 years
7. Severe mental disorders
8. Pregnant or lactating women
9. Other disease requiring simultaneous surgery or radiotherapy
10. Researchers believe that the situation is unsuitable for participation in the group
Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile system or the duodenum that is associated with a high rate of complications. The study wants to investigate whether a new technique to reconstruct the joint between the pancreatic gland and the short bowel can reduce the rate of severe complications after this complex surgical procedure.

Pancreaticoduodenectomy is a complex surgical procedure for radically resecting tumors in the pancreatic head, distal bile duct or duodenum. Postoperative pancreatic fistula is the main contributor of severe postoperative morbidity after pancreaticoduodenectomy. Characteristics of the pancreatic gland like soft pancreatic consistency and small pancreatic main duct predispose for the postoperative fistula development. In high risk patients, the risk of suffering from associated postoperative morbidity is 50 percent which is considered unacceptable high. The aim of the current trial is to investigate whether a new anastomosing technique for the pancreaticojejunostomy can reduce the incidence of associated postoperative morbidity in patients undergoing pancreaticoduodenectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective pancreaticoduodenectomy
* Pancreatic gland with high risk criteria for associated postoperative morbidity

Exclusion Criteria:

* Patients do not accept participation
* Pancreatic gland with intermediate or low risk criteria for associated postoperative morbidity
Assessment of Orality Disorders in Children With Food Allergies

Orality disorders are frequent in child. There are complications like growth and psychomotor development disorders.

The aim is to estimate the prevalence of orality disorder for child with one or several food allergy.


Eligibility Criteria:
Inclusion Criteria:

* Every child aged between 6 month and 6 years, with one or several food allergy and under the care of allergy unity of University Hospital of Angers
* obtention of informed consent

Exclusion Criteria:

* Child with allergy other than food
* poor understanding of french
Diagnostic Possibilities in Ophthalmological Diseases Using Swept Source Optical Coherence Tomography

In this pilot study we want to investigate morphological features acquired by the novel image modality and gain information regarding disease pathomechanism, development and future possible influence on disease management for patients affected by those diseases.


Eligibility Criteria:
Inclusion Criteria:

* Age between 5 and 110 years
* Ability to follow instructions during imaging procedure
* Written Informed consent

Exclusion Criteria:

* Dementia
* Inability to follow instructions during imaging procedure
* Patients who do not give informed consent
Assessment of Pain Associated With Insertion Torque and Correlation of Primary Implant Stability Measurement Methods

The objective of this observational study is to evaluate the primary stability of dental implants and the relationship between insertion torque and patients' pain levels assessed with the visual analogue scale (VAS)

Primary implant stability plays a key role in providing osseointegration. Higher insertion torque indicates higher primary stability. However, the effect of increased insertion torque on patient pain levels has not been clearly demonstrated. Several methods for measuring primary stability have been defined so far. Insertion torque, periotest measurements, and resonance frequency analysis are mostly preferred due to their ease of use and non-invasiveness.

The aim of the present study is to evaluate the relationship between insertion torque and patients' pain levels assessed with the visual analogue scale (VAS) and to assess the relationship between insertion torque, periotest measurements, and resonance frequency analysis.

Eligibility Criteria:
Inclusion Criteria:

* No contraindications for implant surgery;
* Bilateral single-tooth loss in the posterior mandible;
* Sufficient bone amount for implant diameter and height at the implant site;
* At least 3 months after tooth extraction at the implant site;

Exclusion Criteria

* History of chronic infection or pain at the implant site;
* History of radiotherapy to the head and neck region for any reason;
* Local or systemic causes of persistent anti-inflammatory or analgesic medication;
* Patients with suspicion of pregnancy.
A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)

The purpose of the study is to demonstrate the safety and performance of the ACRYSOF® IQ EDF IOL.

Both eyes will be implanted. The second eye implantation will occur a minimum of 7 calendar days and a maximum of 28 calendar days from the first eye implantation.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB) approved Informed Consent Form;
* Diagnosed with cataract in both eyes;
* Planned cataract removal by routine small incision surgery;
* Calculated IOL power is within the clinical study supply range (18.0-25.0 diopter (D) in 0.5 D steps);
* Preoperative regular astigmatism of less than 1.0 D.

Exclusion Criteria:

* Pregnancy or lactation current or planned during the course of the study;
* History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathology including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, age-related macular degeneration (ARMD), glaucoma (uncontrolled or controlled with medication) or ocular hypertension, diabetic retinopathy, retinitis pigmentosa and any optic nerve pathology.