cyrilzakka/clinical-trials huggingface dataset:
Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving

The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type.

The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type.

This study "SWADAPT2" follows "SWADAPT1" with patients with Neurological Disorders, Regular Drivers of Electric Wheelchairs, in the same conditions :

Each patient included will test a wheelchair equipped with a collision avoidance assistance module in 2 conditions, assistance activated or not. This evaluation will be carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with activated assistance, in a random order established upstream.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 18,
* Having read the information note and freely consented to participate in the study,
* Suffering from neurological disorders such as cerebro-lesion or neuro-degeneration,
* Having benefited from an electric wheelchair prescription or learning to drive.
* Having difficulties driving an electric wheelchair impacting their indoor and/or outdoor driving safety, as shown by the WST score.
* The physical measurements (weight, height) are compatible with the use of the electric wheelchair chosen for the development of the robotics assistance module.

Exclusion Criteria:

* Understanding difficulties preventing the realization of the protocol,
* Motor disorders of the upper limb requiring additional driving technical assistance.
Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma Following Local Ablation

To evaluate the efficacy and safety of Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma following Local Ablation

A multicenter, prospective cohort study investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma following Local Ablation，to evaluate the efficacy and safety

Eligibility Criteria:
Inclusion Criteria:

1. 18 years ≤ Age ≤ 75 years, both male and female
2. Patients are diagnosed with HCC via examination of tissues according to Guidelines for Diagnosis and Treatment of Hepatocellular Carcinoma (Version 2017) by NHFPC (National Health and Family Planning Commission of the People's Republic of China) and/or HCC imaging criteria of American Association for the Study of Liver Diseases (AASLD) for the diagnosis of HCC;
3. Radiographic testing shows cancer cells have been eliminated after four weeks of Local Ablation;Complete Response (CR): Dynamic contrast-enhanced CT scans and follow-up MR images show low-density area of Hepatocellular Carcinoma and no enhancement during the arterial phase of contrast-enhanced CT; also patients with 0.5-1 cm beyond the limits of the tumor margins (considered as safe surgical margins) are eligible;
4. According to contrast-enhanced CT and MRI, with solitary tumor smaller than 5 cm in diameter; with multiple tumors (no more than 3 masses), the largest dimension is less than 3 cm;
5. Patients are eligible if Hemoglobin (Hb) count ≥90g/L, platelets count (PLT) ≥60×109/L, absolute neutrophil count (ANC) count \>1.0×109/L, prothrombin activity (PTA)\>50%, serum creatinine is less than 1.5 times ULN (Upper Limit of Normal) and total bilirubin (TBIL) \<51.3μmol/L (3 mg/dL);
6. ECOG score of 0-1;
7. Liver function is Child - Pugh grade A or B.
8. History of TACE for treatment of HCC is less than or equal to twice -
9. The patients are volunteered for the study, sign informed consent form and cooperate with Investigator to collect data.

Exclusion Criteria:

1. Radiographic testing shows cancer cells have not been eliminated after four weeks of Local Ablation;
2. The occurrence of embolism occurs in large blood vessels on liver, patients with extrahepatic metastatic of HCC or liver transplantation;
3. Patients who are about to receive or already received chemotherapy or molecular targeted therapy;
4. Patients who are about to receive TACE treatment for HCC;
5. Patients without previous treatment of Huaier granules.
6. History of diabetes;
7. HCC patients with uncontrollable ascites at the beginning of enrollment of the study or are very likely to have ascites during the next four weeks at the time of enrollment; patients with hepatic encephalopathy or upper gastrointestinal bleeding;
8. Patients have basic diseases including severe cardiopulmonary insufficiency, renal insufficiency, or severe mental illness;
9. Patients with other infectious disease (excluding viral hepatitis)
10. Patients who cannot take oral medication;
11. Conditions that are considered not suitable for this study investigators.
Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis

The purpose of this study is to compare the safety and efficacy of different doses of etanercept for the treatment of moderate to severe psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at time of consent.
* Active, moderate to severe chronic plaque psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving greater than or equal to 10% body surface area (BSA) or PASI greater than or equal to 10.
* In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine and psoralen plus ultraviolet A radiation (PUVA) therapy.

Exclusion Criteria:

* Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
* Rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
* Active or recent (within 2 years) tuberculosis (TB) infection.
Parental Anxiety and Its Relationship With Pediatric Patients' Post-operative Responses

Post-operative delirium had multiple risk factors, such as pre-operative anxiety status, post-operative pain, and anesthetic method. We currently decrease pre-operative anxiety by parental accompanying until the children put to sleep. However, references indicate that parental anxiety can increase the post-operative delirium. Heart rate variability was used to measure the anxiety status of parents. We think sympathetic tone elevation measured by heart rate variability may not induce by anxiety alone, thus we want to explore this question by using Stat-Trait Anxiety Inventory questionnaire.

Outcome measures

1. Post-operative emergence delirium, observed with an average duration up to 24 hours
2. Sedatives used in recovery unit

Eligibility Criteria:
Inclusion criteria:

* American Society Anesthesia (ASA) risks classification I or II

Exclusion criteria:

* Parents who have cognitive problems
* Parents who have difficulty finishing questionnaire
Effect of Bilateral Quadratus Lumborum Block for Pain Relief in Patients With Cesarean Section

Cesarean section commonly induces moderate to severe pain for 48 hours. These patients have additional compelling reasons to provide adequate pain relief as early mobilization is a key factor to prevent the risk of thromboembolic event which is increased during pregnancy. Beside these, patients need to be pain free to takecare for their newborn and breastfeed them. Poorly controlled pain after cesarean section also increases risk of chronic pain and postpartum depression.

Intrathecal morphine is considered the "gold standard" for postoperative pain relief after cesarean delivery. The duration of analgesic effect of morphine extend to 12-24 hours. Its widespread use is due to its favorable pharmacokinetic profile, ease of administration and low cost. Although intrathecal morphine is highly effective, its use is associated with undesirable adverse effect particularly nausea, vomiting and pruritus which reduce overall patients' satisfaction. More serious complication is the risk of delayed maternal respiratory depression.

The Quadratus Lumborum block was first described in 2007 which demonstrates a spread to the paravertebral space, thus leads to a more extensive block to T5-L1 nerve branches and a long lasting block with the potential to provide visceral pain relief. Therefore, this block has an evolving role in postoperative analgesia for many lower abdominal surgeries. As the safety is concerned, there has been one report of a patient with unilateral hip flexion and knee extension weakness leading to unplanned overnight admission following lateral quadratus lumborum block after laparoscopic gynaecological operation.

If the result favors effective, it will have the advantage of a combination with intrathecal opioid to prolong the pain free period after cesarean section which has about 4,000 cases per year.


Eligibility Criteria:
Inclusion Criteria:

* All singleton pregnant women with gestation of at least 37 weeks scheduled for elective cesarean section with American Society of Anesthesiologists (ASA) physical status 1 or 2

Exclusion Criteria:

1. refuse to receive spinal block
2. allergy to drugs used in research: morphine, local anesthetic drug and paracetamol
3. abnormal coagulopathy: congenital coagulopathy or who used anticoagulants
4. platelet dysfunction or thrombocytopenia
5. distorted anatomical structures of lumbar spines
6. systemic infection or local infection at both flank areas which are the punctures sites for quadratus lumborum block
7. unable to comprehend or use the verbal rating pain scoring system or patient-controlled analgesia
First in Patient Study for PF-06840003 in Malignant Gliomas

This study will evaluate the safety and tolerability of increasing doses of PF-06840003 in patients with malignant gliomas.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of WHO Grade IV glioblastoma or WHO Grade III anaplastic gliomas
* For patients with Grade IV GBM, recurrent disease at the time of the first or second recurrence or progression. For patients with Grade III anaplastic gliomas, recurrent disease at the time of at least a first recurrence but no more than a fourth recurrence or progression
* Karnofsky performance score greater than or equal to 70%
* Adequate bone marrow, kidney and liver function

Exclusion Criteria:

* History of CNS bleeding within 6 months of registration
* Previous anti-angiogenics or anti-vascular endothelial growth factor within 12 months of registration
* Requires treatment with high dose systemic corticosteroids defined as \>2 mg/day
* Radiation therapy within 12 weeks of registration
Validation of Respiratory Epithelial Functional Assessment to Predict Clinical Efficacy of Orkambi®.

The purpose of the study is to investigate whether the correction of CFTR function by Lumacaftor/Ivacaftor in a patient-derived primary nasal cell model is a surrogate biomarker for respiratory improvement in Orkambi® treated patients.

Orkambi® is a combination of Ivacaftor (a CFTR channel potentiator) and Lumacaftor (a corrector partially rescuing the traffic of mutated CFTR). This treatment is now marketed in France for patients homozygotes for the mutation p.Phe508del, aged 12 and above. Systematic use of this product is a concern due to the lack of predictive markers of efficacy, the highly variable respiratory improvement in patients and potential serious side effects.

The purpose of this study is to investigate the predictive value for improvement of the respiratory function after 24 weeks of Orkambi treatment of an in vitro test. This test quantifies the correction of CFTR activity as assessed by the change of cyclic AMP (cAMP) dependant chloride (Cl-) secretion in patient derived Human Nasal Epithelial (HNE) derived primary culture after Lumacaftor/Ivacaftor 48 hours incubation.

Eligibility Criteria:
Inclusion Criteria:

* Homozygous F508del patient aged 5 years or older
* Patient with an indication for Orkambi® treatment according to the marketing authorization application
* Patient never received Orkambi® in the past
* Patient able to perform FEV1
* Signed Informed consent form by the patient (if aged ≥ 18 years), or by parents / legal guardian and patient's agreement (if aged \< 18 years) Patient affiliated to the health insurance system

Exclusion Criteria:

* Homozygous F508del patients who do not meet the treatment indications according to the marketing authorization application
* Patients refusing Orkambi®
* CF patients not homozygous for the p.Phe508del mutation
* Active smoker
* Severe nasal mucosa disrepair
* Contraindications to xylocaine anesthesia,
* Participation with another interventional study with drug
High Oral Loading Dose of Cholecalciferol in Non-Alcoholic Fatty Liver Disease

Non-alcoholic fatty liver disease (NAFLD) is a metabolic disorder with high prevalence in patients suffering from chronic liver diseases \[1\]. NAFLD is characterized by the accumulation of \> 5% of fat deposits in hepatocytes (hepatic steatosis) with no known other reasons for steatosis as excessive alcohol intake.The global prevalence of NAFLD differs depending on the population reaching 13% in Africa, 32% in the Middle East, and 30 % in the United States


Eligibility Criteria:
Inclusion Criteria:

* Either male or female adult patients (\>19 years) with fatty liver diagnosis by using upper abdominal ultrasound echography (US) and with type II diabetes diagnosed according to American Diabetes Association (ADA) 2019 criteria and treated with metformin

Exclusion Criteria:

* pregnant and/or lactating women, excessive alcohol use (defined as an average alcohol intake of\> 30 g per day in men and \> 20 g per day in women),
* Other etiology of chronic liver diseases such as viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, patients suffering from chronic kidney disease, and hyper/hypoparathyroidism.
* Hypersensitivity to cholecalciferol, hypercalcemia, patients taking supplementation with vitamin D, and calcium.
* Medications affecting calcium/vitamin D metabolism (as anticonvulsants, glucocorticoids, and antacids).
A Multicenter Cross-sectional Study of Cardiac Ultrasound Phenotypes in Patients With Sepsis

The heart, one of the most important organs for oxygen supply and consumption, is frequently involved in sepsis, i.e. septic cardiomyopathy, also known as septic myocardial suppression. The occurrence of septic myocardial suppression increases mortality in septic patients. Recent studies have found that left ventricular hyperdynamic state (EF \> 70%) is associated with intra-ICU mortality in septic patients, possibly because it reflects unresolved vascular paralysis from sepsis . For septic myocardial suppression, there is still a lack of uniform criteria for diagnosis, but it is well established that the cardiac ultrasound phenotype of septic myocardial suppression can be left ventricular systolic insufficiency (LVSD), left ventricular diastolic insufficiency (LVDD), right ventricular insufficiency (RVD), diffuse ventricular insufficiency, and mixed ventricular insufficiency. According to incomplete statistics, the prevalence of LVSD ranges from 12 to 60%, the prevalence of LVDD is higher, 20% to 79%, and the prevalence of RVD varies from 30% to 55%. However, based on the current understanding of septic myocardial suppression, the relationship between each staging and its prognosis is unclear, and echocardiography can rapidly identify septic myocardial suppression and guide the classification of septic myocardial suppression to further optimize the diagnosis and treatment process of sepsis, especially to avoid over-resuscitation during fluid resuscitation and perform reverse resuscitation in a timely manner to improve patient prognosis and reduce hospitalization time. The aim of this study is to classify and evaluate the prognosis of patients with different septic cardiac ultrasound phenotypes in multiple centers across China by measuring the right and left heart systolic and diastolic indices by echocardiography, recording the baseline conditions and clinical indices of patients, and combining them with the prognosis.


Eligibility Criteria:
Inclusion Criteria:

- All patients with sepsis or septic shock who conform to Sepsis 3.0 diagnostic criteria

Exclusion Criteria:

1. Patients with preexisting chronic heart disease such as cardiomyopathy, chronic pulmonary heart disease, severe cardiac valve disease, coronary heart disease, congenital heart disease, pericardial disease, etc. and with cardiac function ≥ grade III (NYHA classification) prior to sepsis.
2. End-stage malignancies.
3. Severe trauma.
4. Pregnancy.
5. Patients for whom transthoracic echocardiography data are not available.
The Effect of Vocal Rest Versus Vocalization Following Xeomin® Injections in Spasmodic Dysphonia

This study will compare the effects of vocal rest versus continuous vocalization for one hour immediately following botulinum toxin injections for adductor spasmodic dysphonia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with adductor spasmodic dysphonia (ADSD) by an experienced neurologist and otolaryngologist. ADSD patients who have been stabilized on their treatment dose for at least 2 treatment cycles.

Exclusion Criteria:

* Diagnosed with another neurological disorder that is combined with ADSD (i.e. Parkinson's disease and ADSD). Previous history of an additional vocal pathology (i.e. vocal polps, vocal nodules, unilateral vocal fold paralysis, etc.)
A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device

Channel Medsystems, Inc., the manufacturer of the Cerene® Cryotherapy Device (Cerene), is initiating a prospective, observational registry, the Progress registry, to gather data during real world utilization of the Cerene® Cryotherapy Device (Cerene). The primary objective of this registry is to bridge the gap between clinical results and outcomes achieved and reported during the pivotal study of Cerene and those obtained during its real-world use.

Cerene was approved by the FDA in March 2019 for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete. The primary objective of the Progress registry is to bridge the gap between clinical results and outcomes reported during the pivotal study of Cerene (the CLARITY Study) and those observed during its real-world use. The Progress registry will gather prospective, observational data on up to 300 women that underwent a Cerene treatment. Patients and physicians will complete surveys. Surveys will include patient demographic characteristics and quality of life measures at baseline, procedural details, and post-operative clinical outcomes and quality of life measures.

Patient participation is expected to last approximately 13 months, from the time of patient enrollment to 12 months post treatment. The study will end after the last participating patient in completes her 12 month visit.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for a Cerene treatment
* 25 years of age and older
* Provided informed consent to participate in the registry
* English speaking
* Agrees to complete a survey at specified time points from baseline to 12 Months

Exclusion Criteria:

* Physician discretion
* Vulnerable populations
Pediatrician-lead Motivational Counselling to Control BMI in Overweight Children: a RCT in Primary Care

Obesity is one of the leading causes of morbidity and mortality in the industrialised world. Evidence is growing that early life nutrition can play a role in behavioural and cognitive problems in children and adolescents and is well documented that being overweight and obese during childhood can have short- and long-term physical and psycho-social health implications.

This is an individually randomised trial to evaluate the efficacy of a family pediatrician-lead counselling intervention in reducing the BMI of over-weight children aged 4-7 years old. As secondary objectives the investigators evaluate the effect of the counselling on dietary behaviours and physical activity.

The investigators targeted the intervention to overweight children, while obese children were referred to specialised care. The counselling targeted diet, physical activity, and sedentary behaviours.


Eligibility Criteria:
Inclusion Criteria:

* overweight children with BMI percentile between 85° and 94°
* 4-7 years old
* resident in Reggio Emilia Province
* assisted by the pediatrician at least for 12 months

Exclusion Criteria:

* metabolic pathologies and all pathologies related with obesity
* family in pre-contemplation stage
A Comparison of Cervical Spine Movement During Tracheal Intubation Using the Pentax or the Glidescope

Both Glide scope and Pentax laryngoscope are video laryngoscope that provide the better view with minimal cervical spine movement. This study wants to compare cervical spine movement during intubation when using these two devices. The C-spine motion will be recorded by using fluoroscopic video to measure the angular displacement of the vertebrae.

The primary outcome is the angular displacement of the vertebrae and secondary outcome is the hemodynamic changes after intubation.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Age 18-75 years old
* Elective noncardiac surgery requiring general anesthesia with tracheal intubation

Exclusion Criteria:

* Gastroesophageal reflux disease
* Body mass index greater than 35 kg/m2
* Possibility of pregnancy
* Previous neck surgery
* Unstable C-spine/ C-spine abnormality
* Known difficult airway
* Suspected difficult airway
Effect Of Closed Kinetic Chain On Hip Stability In Spastic Cerebral Palsy Post Selective Dorsal Rhizotomy

Purpose of the study:

To evaluate the effect of closed kinetic chain on hip stability after selective dorsal rhizotomy on spastic cerebral palsy.

* This is a prospective randomized controlled clinical trial, conducted at Kafr El sheikh Hospital.
* Sixty-six children of both genders.
* The study will include children (age 5-14years) post selective dorsal rhizotomy.
* Children meeting the inclusion criteria will be randomly assigned to one of two groups:

  * Experimental Group: children in this group will receive closed kinetic chain.
  * Control Group: Patients in this group will receive Traditional physical therapy.
* Randomization will be achieved using computer-generated random numbers to ensure an equal distribution of patients between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* 1-Patients will be aged from 5 to 14 years

  2- will be included both genders post selective dorsal rhizotomy.

  3- The GMFCS level I-II spastic diplegia, able to stand up from a chair independently and maintain standing for more than 5 seconds without falling.

  4- Had not received any strength training program in the past 3 months before the study.

  5- Able to attend physical therapy (PT) treatment at least three a week before and during this study.

Exclusion Criteria:

* 1-have perceptual, cognitive, visual and auditory disorder.

  2- botulinum toxin injection to the lower extremities within 6 Months.

  3- Medical conditions that prevented children from participating in the exercises.

  4- Previous lower extremity surgery, such as prior hamstring muscle Lengthening. 5- Existence of any orthopedic condition or any static hip, knee or ankle deformities.