cyrilzakka/clinical-trials huggingface dataset:
Study of Open and Percutaneous Release of Acquired Trigger Thumb

Trigger finger, also known as trigger digit or stenosing tenovaginitis, is caused by a size mismatch between the flexor tendon and the A1 pulley, which is generally characterized by pain, swelling, the limitation of finger range of motion and a symptomatic locking or clicking sensation. Conservative treatment options include the application of non-steroidal anti-inflammatory drugs (NSAID), physiotherapy, electrotherapy, splinting and corticosteroid injection but not always effective with regard to frequent recurrence. Open surgical release of the A1 pulley remains the gold standard of treating symptomatic trigger finger. While percutaneous release is a minimal invasive alternative and gaining popularity for the index, middle ring and little fingers, investigations for the surgical efficacy on thumb is few and far between. Investigators believe that a carefully conducted operation with proper positioning of the thumb, wide-awake approach and meticulous technique can achieve similar efficacy and safety in terms of possibly less intraoperative pain, imperceptible scar and early return to daily activities and routine work.

The hypothesis of this study is that by using a proper positioning of thumb, wide awake approach and meticulous technique in conducting percutaneous release of trigger thumb can achieve similar efficacy and safety compared to that of open release surgical method. Moreover, percutaneous release of trigger thumb can generate less intraoperative pain, imperceptible scar and promote early return to routine work.

Hence, the objective of this study is to investigate and compare the safety, effectiveness and outcome of percutaneous release versus traditional open release for trigger thumbs.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of trigger thumb with Green's staging graded 2-4
* Patients were unresponsive to conservative treatments for more than 3 months (Nonsteroidal anti-inflammatory drugs, physiotherapy, splinting, or injection of steroid)

Exclusion Criteria:

* With history in rheumatoid arthritis
* Unable to give verbal or written consent.
Covid-19 Vaccine Response in Elderly Subjects

The objective of this research is to assess the amplitude and quality of the vaccine response against SARS-CoV-2, defined here by its characteristics established at 3 months, and its persistence over time, defined here at 9 months, in subjects residing in medical establishment for dependent elderly persons, compared to immunocompetent subjects aged 40 to 65 years (control subjects for vaccination over the same period).


Eligibility Criteria:
Inclusion Criteria:

Target population.

* Elderly persons \> 65 years old residing in an institution for the elderly or in a long-term care unit for whom an anti-SARS-CoV-2 vaccination is indicated as recommended by French Health Authority (HAS)
* Male or female resident in an institution for the elderly or in a long-term care unit
* For whom consent has been obtained prior to any SARS-CoV-2 vaccination (or from the legal guardian/curator) by COMIRNATY®.
* Having consented to participate in the study, and willing to comply with all study procedures and its duration
* Socially insured patient

Control population

* Health and medico-social sector professionals aged between 40 and 65 years old for whom a COMIRNATY® anti-SARS-CoV-2 vaccination is indicated as recommended by the HAS.
* Male or female between 40 and 65 years of age included
* For whom consent has been obtained prior to any COMIRNATY® SARS-CoV-2 vaccination.
* Having consented to participate in the study, and willing to comply with all study procedures and its duration
* Socially insured subject

Exclusion Criteria, for both groups :

* Progressive infectious pathology
* Progressive neoplastic pathology (or remission of \< 5 years)
* Treatment with long-term corticosteroids or immunosuppressants
* Refuse of consent to vaccination or study
Effect of Sacral Erector Spinae Plane Block on Hemorrhoid and Pilonidal Sinus Surgery

Introduction: This study investigated the efficacy of sacral erector spinae plane block (ESPB) for managing postoperative pain and reducing opioid consumption in patients undergoing hemorrhoid and pilonidal sinus (PS) surgery.

Introduction: This study investigated the efficacy of sacral erector spinae plane block (ESPB) for managing postoperative pain and reducing opioid consumption in patients undergoing hemorrhoid and pilonidal sinus (PS) surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-II patients undergoing hemorrhoid and pilonidal sinus surgery

Exclusion Criteria:

* patients with coagulopathies, pregnant women, patients with significant cardiovascular, hepatic, or renal disease, patients who declined spinal anesthesia or were contraindicated for it, and patients who had previously undergone the same surgery
A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients

Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities, are limited and, in the case of absent cochleas, non-existent. An auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1 year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study to determine the safety of the ABI.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral profound deafness due to cochlear aplasia, cochlear nerve deficiency, or ossification secondary to meningitis
* If previously received a cochlear implant, must demonstrate lack of benefit from that device

Exclusion Criteria:

* Medical contraindication to craniotomy/intracranial surgery
* Severe cognitive or developmental delays
A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants

The main purpose of this study is to evaluate how much LY3502970 gets into the bloodstream and how long it takes the body to eliminate when administered orally as tablet and capsule formulations along with effect of food on LY3502970 in healthy overweight and obese participants. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study is conducted in two parts (part A and B) and will last up to 135 days including the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants who are overtly healthy as determined by medical evaluation
* Participants with body mass index (BMI) of 27.0 kilograms per meter squared (kg/m²) or more
* Participants with a stable body weight, with 5% or less body weight gain or loss

Exclusion Criteria:

* Have any type of diabetes with hemoglobin A1c (HbA1c) level of 6.5% or greater or a fasting blood sugar over 120 milligram per deciliter (mg/dL)
* Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome
* Have known clinically significant gastric emptying abnormality
* Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass)
* Known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer
* Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug
* Have significant history of or currently have Major Depressive Disorder or psychiatric disorder within the last 2 years
TACE Plus Multikinase Inhibitor and I-125 Seeds Brachytherapy for HCC With Branch PVTT

This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with lenvatinib and iodion-125 seeds brachytherapy (TACE-Len-I) compared with TACE combined with lenvatinib (TACE-Len) for hepatocellular carcinoma (HCC) with portal vein branch tumor thrombus (branch PVTT).

This is an single center, randomized controlled trial to evaluate the efficacy and safety of TACE-Len-I compared with TACE-Len for the treatment of HCC with branch PVTT.

171 HCC patients with branch PVTT will be enrolled in this study. The Patients will be treated with TACE-Len-I or TACE-Len using an 2:1 randomization scheme.

TACE will be performed for the patients after randomization. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the TACE-Len-I arm, iodion-125 seeds will be implanted into the PVTT (according to the pre-operative planning) under CT guidance within 14 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.

Eligibility Criteria:
Inclusion Criteria:

1. Age between18 and 75 years.
2. HCC confirmed by histopathology and/or cytology, or diagnosed clinically.
3. Accompanied with tumor thrombus involving unilateral portal vein branch.
4. Child-Pugh class A or B.
5. Eastern Cooperative Group performance status (ECOG) score of 0-2.
6. Serum bilirubin ≤ 51.3 μmol/L, albumin ≥ 28g/L, ALT and AST ≤ 5 times of the upper normal limit, and creatinine ≤ 20g/L.
7. Prothrombin time prolonged for less than 4s or international normalized ratio \< 1.7.
8. Neutrophilic granulocyte count ≥ 1.5×10\^9/L, platelet count ≥ 50×10\^9/L, and hemoglobin level ≥ 85g/L;
9. At least one measurable intrahepatic target lesion.
10. Life expectancy of at least 3 months.

Exclusion Criteria:

1. Diffuse HCC.
2. Extrahepatic metastasis.
3. Tumor thrombus involving both the left and right branch of portal vein or main portal vein.
4. Hepatic vein and/or vena cava invasion.
5. History of organ or cells transplantation.
6. Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy or systemic therapy.
7. History of other malignancies.
8. Serious medical comorbidities.
9. Female patients who are pregnancy or breastfeeding.
Effects of Navigated Repetitive Transcranial Magnetic Stimulation According to Post-stroke Aphasia Types

Repetitive transcranial magnetic stimulation induced virtual lesions for aphasia.

To evaluate the effect of navigated repetitive transcranial magnetic stimulation in subjects with aphasia after stroke.

Eligibility Criteria:
Inclusion Criteria:

* fluent in Korean
* older than 18 years old

Exclusion Criteria:

* younger than 18 years old
* psychotic or psychiatric problems
* pregnant
* contraindications to MRI/fMRI
* uncooperative
* metalic implants, pacemaker or cochlear implants
* cannot perform outcome measure-related task
* known seizure history
Minimal Effective Concentration (EC90) of Ropivacaine

Prospective up and down sequential evaluation of the minimal effective concentration of perineural ropivacaine for 90% success in axillary brachial plexus block with the injection of intravenous dexamethasone or saline placebo during regional anesthesia performance

ropivacaine concentration determined by up and down sequential method dexamethasone or saline placebo determined by randomisation

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* ASA Score 1,2 et 3 (American Society of Anesthesiologists Score)
* surgery under axillary brachial plexus block
* signed information consent

Exclusion Criteria:

* pregnancy and breastfeeding
* contraindication to regional anesthesia or technical impossibility
* impaired coagulation
* delay of surgery to short to allow regional anesthesia
* dementia or under administrative supervision
* allergy and contraindication to dexamethasone or ropivacaine
* total dose of ropivacaine higher than 3 mg / kg (recommended dose for upper limb regional anesthesia)
* opioids or pain killers abuse or addiction
* steroids consumption in the past 6 months
* surgery estimated to be greater than 4 hours
* anticipated bad observation of treatment
* patient enrolled in another trial
Evaluation of the Efficacy and Tolerance of B-Back® on the Burnout Syndrome

The purpose of this study is to determine the efficacy and the tolerance of the food supplement B-Back®, containing α-casozepine, taurine, eleutherococcus senticosus and Extramel®, on the burnout syndrome.

The burnout syndrome currently concern all the professional categories. In 2010 the WHO estimated that the three countries with the most important work-related depression are Unites States, Ukraine and France. The direct and indirect costs of work-related stress for the insurance program were not insignificant.

The purpose of this study is to determine the efficacy of the food supplement B-Back® proposed in order to improved the symptoms of the burnout syndrome : stress, fatigue, emotional imbalance, anxiety, sleep, etc.

The main objective is to determine the efficacy of B-Back® on the symptoms suggestive of the burnout syndrome by using the Burnout Measure Short version (BMS-10). The others objectives were to evaluate the tolerance of the product, to evaluate the efficacy of B-Back® on the symptoms suggestive of the burnout syndrome by using the Maslach Burnout Inventory, depression, and the global quality of professional and family life, sleep,and fatigue (energy).

Eligibility Criteria:
Inclusion Criteria:

* males and females outpatients aged 30-65 years old
* practicing professionals in contact with patients, students,...
* symptoms suggestive of burnout syndrome
* minimum score to the BMS-10 = 4
* able to understand the sdudy documents
* agreeing to go to dates of controls
* able to give informed consent
* affiliated to a French national insurance program

Exclusion Criteria:

* current anxiolytic or antidepressant treatment
* allergy known about one of the components of the food complement in the study
* intolerance in the lactose and in the proteins of milk
* pregnancy or feeding
* progressive pathology involving life-threatening during study
* professional on sick leave
* cancer not stabilized for at least five years or considered as not recovered
* subjects deprived of liberty court decision
* subjects in the psychic incapacity to understand the constraints of the study
Perioperative Blood Pressures and Chronic Hypertension

This study aims to assess the performance of presurgical clinic blood pressure measurements in predicting home blood pressure readings among surgical patients. It also aims to measure the association between home blood pressures and patient perspectives on blood pressure control.

A convenience sample of presurgical patients seen in a preadmission testing clinic were enrolled and sent home with a home blood pressure monitor that stored up to 50 readings. Participants were asked to return the BP cuff on the day of their surgery.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients \>= 21 years of age presenting for surgery to a tertiary care preadmission testing clinic.

Exclusion Criteria:

* Inability or unwillingness to independently operate a home blood pressure monitor.
Study of the Penumbra Coil 400 System to Treat Aneurysm

This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System. The primary objective is to gather post market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial and peripheral aneurysms. Approximately 2,000 patients with intracranial or peripheral aneurysms treated by the PC 400 System at up to 100 centers will be enrolled. Data for each patient are collected up to discharge or 3 days post-procedure, whichever occurs sooner. Long term follow-up to one year will be conducted in accordance to the standard of care at each participating hospital.


Eligibility Criteria:
Inclusion Criteria:

Patients enrolled in this study must be those treated according to the cleared indication for the PC 400 System which is for the endovascular embolization of:

* Intracranial aneurysms
* Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
* Arterial and venous embolizations in the peripheral vasculature

Exclusion Criteria:

* Patients in whom endovascular embolization therapies other than Penumbra Coils are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable.
Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

* The investigators aim to determine the clinical and metabolic effects of sleeve gastrectomy with or without omentectomy in the treatment of morbid obesity.
* The investigators hypothesize that the endocrine suppression of ghrelin (appetite hormone)and resistin (insulin antagonist) provided by sleeve gastrectomy and omentectomy (omentum or intra-abdominal fat removal) will provide clinical and metabolic benefits for morbidly obese patients.

This is a phase 3 prospective randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* Morbidly obese VETERANS ONLY (BMI\>35 with comorbidities or BMI\>40)
* Age \> 18

Exclusion Criteria:

* Pregnancy
* Uncontrolled medical or psychiatric conditions
* Previous bariatric procedure
Multiprofessional Advance Care Planning and Shared Decision Making for End of Life Care

Multiprofessional Advance Care Planning and shared decision making for end of live care for terminal patients and their relatives.

The aim of this study is to develop, implement and test a complex intervention for improving patients' preparation for and participation in end of life decisions. In cooperation with local, national and international partners, the investigators will focus on strategies to enhance advance care planning and shared decision making on end of life issues, and documentation and transferability of end of life decisions across health care settings in coordinated approach involving patients, their families and care givers (in and out of hospital).


Eligibility Criteria:
Inclusion criteria: -patients in which the treating physician on the ward would not be surprised if the patient died during the next year (surprise question of Weissman et al 2011)

* male and female patients above 18 years of age
* signed informed consent after being informed
* patients able to appoint a surrogate decision maker (SM) and/or responsible physician to be contacted after discharge

Exclusion criteria: -patients not capable of speaking german

* patients having no responsible physician to be contacted after discharge and no relative/future surrogate decision maker (SM)
* inhouse patients being discharged within the next 2 days or ambulatory patients not regularly coming to the wards (at least every two month)
* patients assessed by their physician to be in obvious denial of their situation (illness/prognosis)
Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine

The purpose of the study is to investigate the effect of bright light therapy, myopic defocus, atropine and the combination in myopia control in schoolchildren.

The present study is a multi-arm randomised clinical trial with a 24-month duration. Subjects will be healthy Hong Kong Chinese schoolchildren with low to moderate myopia. The aims are to determine the clinical effectiveness of bright light therapy on inhibiting myopia progression in schoolchildren, and to determine whether combination therapy using bright light therapy (BLT) and myopic defocus is more effective than monotherapy.

Study population Seven hundred and sixty Hong Kong Chinese children (152 in each) of A. Control group, B. BLT only group, C. BLT and Defocus Incorporated Multiple Segments (DIMS) group, D. BLT and atropine 0.01% group) and E. Atropine 0.01% group aged 7-12 years old will be recruited. They must not have had prior or current myopia control treatment, have no ocular or systemic diseases/abnormalities that affect visual function, refractive development or spectacle lens wear, and no previous intraocular or corneal surgery. They must not have allergy to atropine.

The eligible subjects will be randomly assigned into one of the four groups. Their cycloplegic refraction and axial length will be monitored every six months for 2 years. The changes in refractive errors and axial length between groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Myopia of at least -0.75D (spherical equivalent) in both eyes
* Age at enrolment: 7-12 year; Hong Kong Chinese
* Astigmatism and anisometropia: 1.50D or less
* Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better
* Parents' understanding and acceptance of random allocation of grouping and masking
* Able to wear the prescribed spectacle, put on eye drop and undergo light therapy daily.

Exclusion Criteria:

* Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)
* Previous intraocular or corneal surgery
* Systemic disease that may affect vision, vision development (e.g. endocrine, cardiac and respiratory diseases, diabetes, Down syndrome, etc.)
* Allergy to atropine
* Previous gas permeable, soft bifocal, or orthokeratology contact lens wear or bifocal/PAL/specific myopic control spectacle wear or use of atropine or pirenzepine (longer than 1 month of wear)
* Previous or current participation in myopia control studies
A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin

Primary objective of this trial is to identify the maximum tolerated dose (MTD) of paclitaxel combined with a fixed dose of cisplatin (75 mg/m2) delivered as hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with ovarian cancer.

In this single-center Phase I trial, Bayesian Optimal Interval Design (TITE-BOIN) was used. The starting dose for paclitaxel was 175 mg/m2, with escalation in 25 mg/m2 increments until the MTD was determined or the maximum dose level of 225 mg/m2 was reached. The target dose-limiting toxicity (DLT) rate was 25%, and the total sample size was 30 patients.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65 years;
* adequate renal function (blood creatinine: 58-96 µmol/L), bone marrow function (hemoglobin ≥ 110 g/L, white cell count ≥ 4.0 ×109/L, neutrophil count ≥ 2.0 × 109/L, platelet count ≥ 100 × 109/L) and hepatic function \[bilirubin 3.4-22.2 µmol/L, alanine aminotransferase (ALT) 7-40 U/L, aspartate aminotransferase (AST) 13-35 U/L, AST/ALT≤ 1.5\].

Exclusion Criteria:

* Patients who had been treated with cisplatin OR paclitaxel for any reason within 3 weeks prior to HIPEC.
* A history of HIPEC treatment