cyrilzakka/clinical-trials huggingface dataset:
Non-invasive Cardiac Index in Children

This study investigates the level of agreement of two non-invasive cardiac output monitors (transthoracic echocardiography and electrical cardiometry) in young children under anesthesia.

Young children are particularly prone to hemodynamic instability during the perioperative period which, in turn, may lead to organ morbidity. Currently, in routine surgical procedures in otherwise healthy children, hemodynamic status in the perioperative period is primarily assessed by non-invasive systemic blood pressure management. While this approach can detect systemic arterial hypotension, it does not provide us with guidance on whether the decrease in blood pressure is the result of changes in cardiac output and/or in systemic vascular resistance. This information would be important to know since treatment modalities may differ.

Recent technical development in electrical cardiometry allows us to non-invasively monitor cardiac output. The accuracy of the method has been validated in neonatal and paediatric cohorts, and electrical cardiometry is now regularly used to monitor cardiac output in the perioperative setting. Nevertheless, the trending patterns of cardiac output in otherwise healthy young children undergoing routine surgical procedures, still need to be described. Due to technical aspects, transthoracic echocardiography is now recognised as "gold-standard" measurement of cardiac output in paediatric patients.

This study is based on a commonly and non-invasively applied monitoring equipment (ICON) which is now regularly used on anesthetized children for the detection of cardiac output during the perioperative period. The primary objective of this validation study is to confirm the non-inferiority of cardiac output measurement with electrical cardiometry versus transthoracic echocardiography in young children ( 0-17 months of age) during the perioperative period.

The secondary objective is to describe the trending aspects of cardiac output during the anaesthesia until the recovery.

Eligibility Criteria:
Inclusion Criteria:

1. Age 0 to 17 months included
2. Greater than 36 weeks post-menstrual age (PMA) on the day of the study
3. Undergoing general anaesthesia for surgery that is expected to last more than 30 minutes (combines anaesthesia and surgical time)
4. Parental/guardian understands and reads French and permission (informed consent) obtained
5. ASA 1-3 status

Exclusion Criteria:

1. Structural/anatomical anomaly or other circumstances (e.g., patient positioning) making it difficult to apply the sensors to the body or limiting the feasibility of the TTE
2. Any Congenital heart diseases
3. Known allergy to electrodes' glue
4. Thoracic, cardiac and head surgery
5. Traumatic surgery with hemodynamic instability
Multimodal Physical Therapy With Exercise in Partial-thickness Rotator Cuff Tears

The aim of this study is to investigate the early stage effectiveness of multimodal physical therapy with exercise in the conservative treatment of partial thickness rotator cuff tears.

Although partial thickness rotator cuff tear prevalence is greater than those of full-thickness tear, most studies on conservative treatment are associated with full-thickness tears. In general, any physical therapy modality alone is not effective in the treatment of rotator cuff tears. It has been reported that multimodal physiotherapy may be more successful than monotherapy, but evidence in this regard is inadequate. Therefore this observational prospective study aiming to investigate the effectiveness of physiotherapy in the treatment of rotator cuff tears was planned. The null hypothesis of this study is that multimodal physical therapy combined with exercise has no effect on pain and function in the treatment of partial thickness rotator cuff tears. The alternative hypothesis is the opposite.

Patients will be assessed by standardized measures in terms of pain and function (American Shoulder and Elbow Surgeons standardized shoulder form: patient self report section), active range of motion (goniometric measurement) and quality of life (Western Ontario rotator cuff index) at baseline and first, third and 6th months of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic partial thickness rotator cuff tear verified with magnetic resonance imaging or ultrasound imaging
* Prescription of multimodal physical therapy with exercise by a clinician other than investigators prior to inclusion in the study
* Covered by the social security system
* Giving informed consent to include in the study

Exclusion Criteria:

* Age of under 50
* Full thickness rotator cuff tear
* Radicular pain
* Glenohumeral osteoarthritis
* Calcific tendonitis
* Adhesive capsulitis
* History of physiotherapy in last 6 months
* Prior surgical treatment
* Contraindication to physical therapy and/or exercises
Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol

Opioid-induced constipation (OIC) is a common feature in patients treated with strong opioids. Such medication is often prescribed together with a laxative (osmotic, emollient), with effectiveness depending on the individual patient. Peripherally-acting, mu-opioid receptor antagonists (PAMORAs), such as Naloxegol, have proven to be effective against OIC in patients with inadequate response to laxatives without reducing opioid analgesic effect. However, evidence regarding efficacy and safety on patients with cancer is still scarce. The objective of this study was to analyze the efficacy of naloxegol in a real-world setting by assessing Quality of Life outcomes, and to obtain data on its safety in the long term in patients with cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Cancer
* Treatment with opioids
* OIC symptoms
* Inadequate response to laxatives
* Karnofsky equal or above 50
* Ambulatory
* Must be able to complete questionnaire forms

Exclusion Criteria: at the start of the study:

* Hypersensitivity to Naloxegol or vehicle
* Suspicion or high risk of gastrointestinal block
* High risk of GI perforation
* Severe liver failure
* Pregnancy or breastfeeding
* Use of potent CYP3A4 inhibitors
* Cognitive impairment
FNB in Meniscal Tear Under SA

The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for meniscal tear under spinal anesthesia

This study is a randomized controlled trial of 100 patients, who underwent history taking, physical examinations, x-rays, and MRI or ultrasonography, and were diagnosed with meniscal tear from september 2023 to august 2028. The 100 patients will be assigned to Group I (with femoral nerve block) or Group II (without femoral nerve block) under double-blinded randomization. The randomization will be performed by an independent nurse using a computerized random sequence generator. The operators who participated in the procedure will be blinded to the participant's information. Both group will undergo spinal anesthesia for arthroscopic meniscal surgery. After anesthesia, sono-guided femoral nerve block will be performed. The injection for group1 is 20 mL ropivacaine and for groupII is 20 mL 0.9% saline. A visual analog scale (VAS) for pain will be recorded 1, 3, 6, 12, 18, 24, 36, 48 hours after the operation. VAS scores range from 0 to 10, with 0 being no pain and 10 being the most severe pain ever experienced. Injection with ultrasonography will be performed by a single anesthesiologist. 3 orthopedic surgeons will perform the surgery.

Eligibility Criteria:
Inclsuion Criteria:

* individuals who are scheduled to undergo meniscal surgery and must be received sufficient explanation about the research prior to surgery and have provided their informed consent to participate.

Exclusion Criteria:

* who require simultaneous surgery for concomitant cartilage injury, collateral ligament tear.
* who have previously undergone surgical treatment within the knee joint.
* who have declined to participate in the research.
* where medical, surgical, or anesthetic complications occurred during surgery.
* other cases deemed necessary by the researchers.
Comparison of the Effect of Online Physical Exercise and Computerized Cognitive Stimulation in Patients With Alzheimer's Disease

Our aim has been determined to investigate the effect of physical exercise alone and in combination with cognitive exercise, on cognitive, physical function and quality of life in individuals with Alzheimer's Disease during the Covid-19 pandemic period.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 65 years and older
* Diagnosed with AD according to DSM-IV diagnostic criteria by a neurologist,
* MOCA ≥ 13
* Clinical Dementia Rating Scale \< 2
* Having sufficient wireless support or telephone connection where the person lives
* Who gave consent to participate in the study
* No history of any neurological or orthopedic injury that could prevent participation in the study and affect functional mobility.

Exclusion Criteria:

* Geriatric Depression Scale score \> 11
* Various mobility restrictions, musculoskeletal disorders, (wheelchair use, etc.)
* Clinically significant aphasia (must be able to understand the therapist's commands)
* Significant visual or sensory impairment
* MoCA \< 13
* Having a severe musculoskeletal disorder
* Having paralysis
* Impaired balance
* The presence of severe lung and heart disease
Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke

The CLEVER Study is a prospective, 2-arm, randomized, single-center pilot study to assess the safety and efficacy of intensive blood pressure control using Clevidipine (on-label use) in AIS patients undergoing standard of care mechanical thrombectomy (MT) within 24-hours of symptoms onset.

The CLEVER Study is a prospective, 2-arm, randomized, single-center pilot study to assess the safety and efficacy of intensive blood pressure control using Clevidipine (on-label use) in AIS patients undergoing standard of care mechanical thrombectomy (MT) within 24-hours of symptoms onset. Eligible patients will be randomized 1:1 to a systolic blood pressure goal after successful MT (mTICI 2c or greater) of either: 90-120mmHg (Intensive BP management group) or 90-160mmHg (Standard BP management group). Patients enrolled into the study will be followed and assessed for up to 3 months.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18 or older
* 2. Acute hypertension (systolic blood pressure of greater than 140 mmHg) at recanalization
* 3. Anterior circulation ischemic stroke symptoms and confirmed occlusion (ICA, M1, or M2) on angiogram with mechanical thrombectomy initiated within 24 hours since last known well
* 4. Success revascularization score of mTICI 2c or higher after mechanical thrombectomy
* 5. ASPECTS score of greater than 6
* 6. Premorbid mRS 0-4
* 7. Signed informed consent within 30 minutes from end of MT procedure.

Exclusion Criteria:

* 1. Presence of any hemorrhage and/or ASPECT score ≤6 on baseline head CT scan
* 2. Pregnant or lactating
* 3. Acute traumatic brain injury
* 4. Patient on active dialysis
* 5. Intracranial neoplasm
* 6. Acute or recent STEMI in the last 30 days
* 7. Severe arrhythmias, unstable cardiac function
* 8. Any terminal medical condition with life expectancy less than 6 months
* 9. Concurrent enrollment in another trial that could confound the results of this study
Colchicine Plus Phenolic Monoterpenes to Treat COVID-19

In this randomized controlled clinical trial, defined cases of COVID-19 with mild, moderate, or severe pneumonia (according to the NIH guideline) were treated with conventional treatment regimens (controls) as well as in combination with oral administration of colchicine plus herbal phenolic monoterpene fractions (intervention arm). After randomization, each group received the mentioned treatments and were evaluated for different variables including mortality, hospitalization duration, intensive care unit (ICU) administration ratios as well as laboratory variables such as leukocytes and lymphocytes count. The follow-up period considered as 2 weeks after discharge. The mentioned variables were assessed as before and after receiving the treatment in each group as well as intergroup analysis for comparing both baseline and final values.


Eligibility Criteria:
Inclusion Criteria:

* Defined cases of COVID-19 based on laboratory and/or radiological and clinical manifestation

Exclusion Criteria:

* Age \<10, Pregnancy, Sever kidney dysfunction, Previous history of allergy to Colchicine, not willing to sign informed consent form
Next Generation pErsonalized tX(Therapy) With Plasma DNA Trial-2 in Refractory Solid Tumors (The NEXT-2 Trial)

Analysis of cell free DNA(cfDNA), unlike tissue biopsy, presents a new tool for the monitoring and treatment of cancer. The investigators have developed a differentiated sequencing assay, Digital Sequencing Technology (DST) that enables detection of rare genomic abnormalities with ultra high-specificity and sensitivity. The investigators assay is able to eliminate the error and distortion created by sample-prep and sequencing processes in standard NGS(next-generation sequencing ) workflows and produce near-perfect representations of all rare variants.

The investigators have shown that in sequencing a comprehensive cancer panel of 80kbp in 0.1% cancer cell line titration samples, standard Illumina SBS(sequencing by synthesis ) generates many high-quality false positive variant calls in the range of 0.05-5%, while the investigators assay resulted in highly sensitive and completely error-free variant calls across the entire panel.

This work indicates the remarkable potential of using the investigators assay in deep analysis of cfDNA, thereby allowing researchers and clinicians to comprehensively and non-invasively monitor the genetic dimension of cancer throughout the body.

Same as above

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 20 years
* Patients with histologically confirmed metastatic gastrointestinal cancer, rare cancer, lung cancer
* Patients with histologically confirmed metastatic cancer, who do not have sufficient biopsy material to undergo mutational testing of their tumor, or do not have feasible biopsy sites; melanoma/lung cancer and any solid tumor cancer types will be eligible for the study.
* Written informed consent form

Exclusion Criteria:

* Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety.
* Double primary cancer (except for any cancer in remission for \> 5 years, cervix cancer in situ, basal cell cancer in situ, any in situ cancers that are resected)
Efgartigimod in IVIG Dependent Myasthenia Gravis Patients

This study is an open label, single center, prospective, 26 weeks study with descriptive analysis where IVIG is replaced by efgartigimod therapy. MG-ADL and MGQOL evaluations will occur weekly throughout the study to week 26.

Objectives:

To determine if efgartigimod is equivalent or non-inferior in efficacy to IVIG in the treatment of stable, acetylcholine receptor antibody positive, IVIG dependent myasthenia gravis patients.

To determine patient treatment preference between IVIG and efgartigimod in stable, IVIG dependent acetylcholine receptor antibody positive myasthenia gravis patients.

To determine the safety and tolerability of efgartigimod administered in a fixed regular dosing regimen over 6 months in stable IVIG dependent acetylcholine receptor antibody positive myasthenia gravis patients.

IVIG will be discontinued one week prior to the baseline visit (week 0) while other concurrent medications (non-steroidal immunosuppressive therapies (NSISTs), acetylcholinesterase (AChE) inhibitors or corticosteroids) for myasthenia will be kept unchanged for the duration of the study. The dose and frequency of efgartigimod treatment will be 10mg/kg (max of 1200mg) administered as a one-hour intravenous infusion every week x 4 infusions followed by a four-week break and repeated for a total four treatment cycles till week 24 and then followed by a two-week observation with an end of study visit at week 26.

Eligibility Criteria:
Inclusion Criteria:

* 1. Signed informed consent. 2. Age 18-80 years 3. Acetylcholine receptor antibody positive, myasthenia gravis patients, with stable disease for the past four or more months. Stable disease is defined as no change in dosage or interval in IVIG treatments and without any significant change in clinical status.

  4. No modification or addition of NSISTs in the past six months 5. No modification or addition in corticosteroid therapy for the past three months 6. Myasthenia Gravis diagnosis was supported by abnormal neurotransmission test or history of improvement with AChE inhibitors.

  7. Receiving chronic regular IVIG treatments for myasthenia gravis for the past year or more.

Exclusion Criteria:

* 1. Patients with previous rituxan or eculizumab treatment or plasma exchange within the past six months 2. Patients with previous thymectomy within the past 3months 3. Patients that have active Hepatitis B, are seropositive for Hepatitis C or HIV or have latent, untreated or active TB or any other significant active infection 4. Patients that have at screening a serum IgG less than 6.0gm/L or a history of chronic hypogammaglobulinemia from any cause.

  5. Patients that are pregnant or considering becoming pregnant in the next 6 months.

  6. Patients with severe renal impairment (eGFR less than 30ml/min) 7. Patients who in the opinion of the investigator should not participate in the study.
Study Evaluating the Helical Ureteral Stent

The Boston Scientific Helical Stent is a unique stent designed to improve flexibility and comfort. It is designed to conform more to the shape of the ureter (hollow tube connecting the kidney and the bladder) to ultimately improve patient comfort and decrease the need for painkillers.

Ureteral stents have been used for many years for a variety of clinical indications. Many surgeons routinely use ureteral stents after the endourologic removal of stones to facilitate in urine passage and facilitate excretion of any left over stones. There is a multitude of literature that reveals that most patients find ureteral stents to be uncomfortable. This discomfort often causes pain severe enough that patients anxiously anticipate stent removal, and often request early stent removal, and/or require use of pain medications that have many side effects and cause further discomfort to these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female; female patients must be sterile, post-menopausal or willing to use birth control during the course of the study
2. 19 years of age and older
3. Having undergone Shockwave Lithotripsy-SWL, or a diagnostic ureteroscopy or uncomplicated ureteroscopy for stone removal requiring retrograde placement of a ureteral stent for an anticipated duration of between 2 and 21 days
4. Willing to sign the Informed Consent Form
5. Able to read, understand, and complete patient questionnaires

Exclusion Criteria:

1. Active, symptomatic urinary tract infection
2. Non-stone related distal ureteral obstruction or stricture
3. Clinically significant trauma or significant retained stone burden that could significantly contribute to patient discomfort
4. Ureteral perforation or trauma
5. History of bladder reconstruction or interstitial cystitis
6. Spinal cord injuries

6. Pregnant or lactating females 7. Non-stone related voiding dysfunction requiring supplemental bladder drainage tubes for more than 24 hours post operatively 8. Patients with a solitary kidney 9. Chronic use of pain or anti-spasmodic medication for symptoms other than stone related pain 10. If in the opinion of the Investigator, the patient is not a suitable study candidate.
Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer

The goal of this study is to compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life.

The main questions it aims to answer are: the difference of anal function 1 year after surgery type of study: clinical trial participant population: patients with low rectal cancer Participants will receive Parks operation of Bacon operation If there is a comparison group: Researchers will compare Parks and Bacon operation to see if the anal function 1 year after surgery is different.

objective: To compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life.

primary outcome: Low Anterior Resection Syndrome (LARS) score 1 year after surgery secondary outcomes: 1. LARS score at 3 months after surgery 2. LARS score at 6 months after surgery 3. Postoperative Quality of Life Score 4. The incidence of postoperative anastomotic complications

Eligibility Criteria:
Inclusion Criteria:

1. Men or women, aged between 18 and 75 years;
2. Pathological diagnosis of rectal cancer before operation, with the distance from the lower edge of the tumor to the dentate line ≤ 3cm by MR imaging;
3. No local complications (including complete/ incomplete obstruction, active bleeding, local invasion of sphincter or levator ani, etc.) before operation;
4. Suitable for anal preservation surgery discussed by MDT;
5. Adequate bone marrow, liver, renal and cardiac function meeting the requirements of surgery and anesthesia;
6. R0 resection is expected technically;
7. Provision of written informed consent.

Exclusion Criteria:

1. Previous history of malignant colorectal tumors;
2. Complications such as obstruction and gastrointestinal bleeding that need an emergency operation;
3. Unachievable R0 resection due to invasion of adjacent organs by primary tumor;
4. Multiple primary tumors;
5. History of other malignancy;
6. Participation in other clinical trials within the previous 4 weeks of enrollment;
7. ASA physical status score ≥ IV level and/or ECOG performance status ≥ 2;
8. Intolerance of surgery due to liver, renal, cardiopulmonary or coagulation dysfunction, or underlying diseases;
9. History of serious mental disorders;
10. Women in pregnancy or lactation period;
11. Uncontrolled infection before operation;
12. Unsuitable to be included due to other clinical and laboratory conditions by the judgement of investigators.