cyrilzakka/clinical-trials huggingface dataset:
General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke

In France, the annual incidence rate of acute ischaemic stroke is around 150 000 patients, 65 % of whom keep long-term disability. Several multicentric randomized controlled trials have shown the benefit of a mechanical thrombectomy in the acute phase of ischaemic stroke on functional disability, compared to a medical treatment alone (thrombolysis).

The timeliness of revascularisation is an essential factor of good prognosis. This intra-arterial treatment, associated with thrombolysis if applicable, is the reference treatment of large-vessel occlusion. The stillness of the patient is required to control the safety of the recanalization. Currently, either a general anesthesia or a sedation can be performed.

Several studies have shown a trend to superiority of the sedation but none was conducted with a high level of proof methodology.

The aim of our multicentric randomized controlled trial is to compare sedation and general anesthesia during intra-arterial thrombectomy for an acute ischaemic stroke in the anterior cerebral circulation. The main outcome will be the efficacy on the functional neurological prognosis at 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Body mass index \< or equal to 35 kg/m² ,
* Indication for thrombectomy, after multidisciplinary consultation,
* Proximal artery occlusion in the anterior circulation (internal carotid artery, M1, M2,...), confirmed on imaging (angioscan or angio-MRI),
* Written informed consent of the patient or a close / trusted person when possible, or emergency procedure,
* Patient affiliated to or beneficiary of an health insurance

Non-inclusion Criteria:

* Comorbidity committing short-term prognosis,
* Hemodynamic instability,
* Pregnant woman,
* Contra-indication to sedation: pre-existing swallowing impairment; restless patient, not able to stay lying down; Glasgow score \< 8,
* Contra-indication to general anesthesia,
* Intubated patient at inclusion,
* Additional intracerebral hemorrhage,
* Sign of occlusion in a different cerebral territory,
* Known contra-indication to succinylcholine: hypersensitivity, hyperkaliemia,
* Known contra-indication to one of the anesthesic agents,
* Patient participating in another clinical trial, possibly interfering with the study procedures,
* Patient in a known situation of deprivation of freedom, guardianship or curatorship.

Exclusion criteria:

* Patients with deprivation of freedom will be excluded as soon as the investigator will have knowledge of the situation.
Serum Adiponectin as an Early Marker for Renal Impairment in Patients With Non-alcoholic Fatty Liver Disease.

Early detection of renal impairment in patients with non-alcoholic fatty liver disease and its correlation with serum Adiponectin level.

Detection of serum Adiponectin by ELISA technique using (EIA-3418) KIT, DRG international inc., USA

Eligibility Criteria:
Inclusion Criteria:

* Patients with fatty liver aged from 18 to 60 yrs either diabetic or not .
* Patient with normal echogenic kidney in ultrasound and eGFR more than 60 mL/min/1.73m2.
* The Control group are completely healthy subjects without any systemic or liver and kidney affection

Exclusion Criteria:

* Patients less than 18 yrs \& more than 60 yrs .
* All patients having any other causes of renal and hepatic disease rather than Diabetes and having any other systemic problem.
Quantitive And Qualitive Assessment Of The Oxygen Delivery And EtCO2 Sampling With The Smart Bite Block Mark III During An Upper Endoscopic Procedure Under Sedation

The study hypothesis is that a modified smart bite block system can deliver up to 10 liters/minute of supplemental oxygen orally with the CO2 monitoring performance substantially equivalent to the currently marketed smart bite block that delivers oxygen up to 5 liters/minute


Eligibility Criteria:
Inclusion Criteria:

* For the Adults Bite Bloc:Adults \>18 years old and able to understand and give consent per the Ethics committee requirements,or younger patients requiring an Adult size Bite Bloc in the opinion of the PI for whom the legal guardians consented for the participation of the trial.
* Patients consented or which their legal guardians consented for the participation of this trial.
* Clinical need to use a Bite Bloc to maintain an open mouth and protect the endoscope.
* Pediatric patients:patients with small mouth that the PI thinks require a Pediatric Bite Bloc (36 French),which their legal guardians consented for the participation of this trial.

Exclusion Criteria:

* Patients who are pregnant.
* Patients who in the opinion of the investigator should not participate.
* For Pediatric Bite Bloc:patients who need an Adult Bite Bloc to the investigators opinion or above the age of 12.
* Patients receiving oral or intravenous anticoagulants other than Aspirin or Plavix.
MRI Imaging of Labeled Human Islets Transplanted Into the Liver

The purpose of the study is to determine whether human islets labeled by iron contrast agents could be imaged using magnetic resonance after transplantation into the liver of Type 1 diabetic recipients.

Islet transplantation represents approved therapeutic approach in selected Type 1 diabetic recipients with syndrome of hypoglycaemia unawareness. Existing imaging methods are not sufficient to provide adequate information about amount and fate of islets transplanted into the liver. Labeling of islets with superparamagnetic contrast agent ferucarbotran significantly shortens T2 relaxing time and therefore increase the contrast between islets and liver tissue in magnetic resonance imaging. In consequence, islets transplanted into liver could be easily detectable like hypotensive areas dispersed throughout the liver. MRI examination will be done on 1, 2, 4 weeks and 3, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus
* normal renal parameters
* hypoglycaemia unawareness or rapid progression of diabetic retinopathy or neuropathy

Exclusion Criteria:

* acute and chronic liver disease
* malignancy
* acute infection
* serious cardiovascular disease
* coagulopathy
* portal hypertension
* presence of metal protesis, cardio-stimulators, or other metal material in the body
Immunological Profile for Patients Treated With CAR-T Cells

In the frame of Si-CART study, blood will be collected from patients treated with CAR-T cells: before (at Day (D)-6 and D0 before cells injection), post infusion at D3, D5,D7, D9, D11, D14, D18, D 21, Month (M) 2 and M12 post injection.

A cerebrospinal fluid sample will also be collected if a Cerebrospinal Fluid Analysis Lumbar puncture is performed


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Planned injection of CAR-T cells within the scope of marketing authorization
* Signed informed consent
* French social security affiliation

Exclusion Criteria:

* Pregnant women, or women of childbearing potential (without medically acceptable contraception) or breastfeeding women.
* Patient in emergency situation, adult under legal protection (patient placed under tutorship, curatorship, or judicial protection) or unable to give his consent
* Impossibility to comply with trial medical follow-up for geographic, social or psychological reasons
Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System

This study is designed to evaluate background fluorescence of participants of different ages, gender, and skin color. In addition, 48-hour tolerability of the sensor and adhesive will be evaluated.

The MediBeacon Transdermal GFR Measurement System investigational is intended to measure the Glomerular Filtration Rate (GFR) in patients with normal or impaired renal function by noninvasively monitoring fluorescent light emission from an exogenous tracer agent (MB-102) over time. The device utilized in this study is the Brilliance device. Approximately 1 male and 1 female from each age cohort (18-50 years; 51+ years) and clustered Fitzpatrick Skin Scale groups (I-II \[Light, pale white; white, fair\]; III-IV \[Medium, white to olive; olive, moderate brown\]; and V-VI \[Brown, dark brown; black, very dark brown to black\]) will be recruited, for a total of 12 participants. Participants will have Brilliance device sensors placed on two locations on their skin, which will remain for 48 hours. The sensor location will be prepared through shaving and cleaning (as applicable), placed on the skin via standard single-use adhesive pads, and baseline measurements collected. Participants may undergo activities of daily living while measurements are being collected. Light pressure and other minor perturbations may be applied to the sensors to evaluate the effect on background fluorescence. Adverse events associated with sensor placement (such as skin irritations) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults age 18 and older
* 2 age cohorts to be recruited: 18 - 50 years of age and 51+ years or older
* Skin color groups to be recruited in accordance with the Fitzpatrick Skin Scale (I - VI)
* Participants willing to sign the Institutional Review Board (IRB) approved informed consent form prior to the initiation of any study specific procedures.

Exclusion Criteria:

* History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
* Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial
* Significant scarring, tattoos or alterations in pigmentation on the standardized sensor locations that would alter sensor readings versus other areas of the skin
Subjective Study to Assess the Efficacy of APD125 in Patients With Sleep Maintenance Insomnia

This study is designed to compare 2 doses of APD125 (20 mg and 40 mg) with placebo in otherwise healthy adults with primary insomnia primarily with complaints of maintaining sleep. Participants will be required to maintain a daily sleep dairy for up to 3 weeks while on study.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 18 to 65 years
* Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by patient reported sleep diaries
* Generally good health

Exclusion Criteria:

* History of any sleep disorder, other than primary insomnia (e.g., restless leg syndrome, narcolepsy, sleep apnea, and disorders of REM/NREM sleep)
* Any clinically significant medical condition, laboratory finding, or ECG finding
* Pregnant and/or lactating females
* History of substance abuse within 2 years or positive urine drug screen
* Positive Hepatitis B/C results or HIV markers
* History of treatment with an investigational drug within the last month
* Recent travel involving crossing more than 3 time zones or plans to travel to another time zone (\> 3 time zones) during the study
Detection and Prognostic Value of Recurrent XPO1 Mutations of Patients With Classical Hodgkin Lymphoma

The purpose of this study is to determine if the XPO1 E571K mutation could be used as molecular residual disease biomarker in classical Hodgkin's lymphoma. To determine the interest of the mutation assessment by digital Polymerase Chain Reaction, sensitivity and specificity after 2 courses of chemotherapy (C2) will be compared with the deltaSUVmax determined by Positron Emission Tomography after C2 and at end of treatment.

A research team of Centre Henri Becquerel recently detected an unexpected recurrent point mutation of XPO1 (exportin 1) (also known as Chromosome Region Maintenance 1) located in exon 15 (c.1711G\>A) leading to the Glu571Lys (p.E571K) missense substitution in relapsed/refractory (R/R) Primary Mediastinal Large B-cell Lymphoma (PMBL) patients included in the LYSA LNH03 trial program and in classical Hodgkin's Lymphoma patients. It was found recurrent XPO1 E571K mutations in a large cohort of 94 patients with classical Hodgkin's lymphoma. This observation is new and could add new information on driver events and tumorigenesis in this disease. In total, 24.2 % of the patients with classical Hodgkin's lymphoma harbored the XPO1 E571K mutation. It is remarkable that 29% of all XPO1 mutations were only found in the plasma but not in the tumor because of the well-known tumor cell sparsity in Hodgkin's lymphoma. In this particular disease, highly sensitive techniques like digital Polymerase Chain Reaction and targeted Next-Generation Sequencing are essential to highlight low frequency mutations. The research team of the Centre Henri Becquerel have identified a trend toward unfavorable prognostic impact in terms of progression-free survival in patients with detectable XPO1 E571K mutation in plasma cell-free DNA at the end of treatment, which could prove to be statistically significant in a larger cohort. It was observed that 57% of patients who ultimately relapsed were positive in the plasma after end of therapy. It remains to be established whether this mutation adds new relevant value as compared to Positron Emission Tomography-scan.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Pathologically confirmed, recent diagnosis of classical Hodgkin Lymphoma
* treatment planned with Adriamycin Bleamycin Vinblastine Dacarbazine (ABVD) or Bleomycin Etoposide Adriamycin Cyclophosphamide Vincristine Procarbazine Prednisone (BEACOPP) regimen (and radiotherapy if applicable)
* all stages (Ann Arbor I - IV)
* Written informed consent
* Patient affiliated or beneficiary of a benefit system
* untreated patient (no corticosteroids or chemotherapy)

Exclusion Criteria:

* No informed consent
* Treatment by ABVD or BEACOPP not indicated
* Previously treated Hodgkin lymphoma (including corticosteroids)
* Patients who are pregnant or lactating
* Active Hepatitis B or Hepatitis C infection
* Known human immunodeficiency virus (HIV) infection - Patient with no social protection
* Patient under tutorship or curatorship
* Patient not affiliated of beneficiary of a benefit system
* Medical contraindication to PET/CT
Healthy Sport Project; Preventing Eating Disorders in Sport

The "Healthy Sport Project" is an adapted program from the Body Project by prof Eric Stice, aiming to reduce body dissatisfaction and symptoms of disordered eating and eating disorders in adolescent elite athletes. This trial aim to evaluate the effect of the program using a one-arm pilot study design in 14 years age old athletes at a Norwegian Elite Sport Junior High School.

Eating disorders (EDs) are serious illnesses with highest incidence in adolescents. Moreover, athletes have a higher frequency of symptoms of disordered eating (DE) and EDs than non-athletes. There are many reasons to this health issue, but body appearance pressure, competing in body mass sensitive sports, and comments on body appearance are important explanations. Few programs have proved effective in preventing DE and EDs in the general population, or in athletes specifically, and none is permanent operative in sports in Norway. Body Project by prof Eric Stice have proved effective in preventing body dissatisfaction, figure idealization and new onset of EDs in female adolescents above 15 years of age, and with body dissatisfaction, from the general population. A few attempts to adapt this program to female athletes, argue for a comparative positive effect. Three important elements to further address, are: 1) programs need also to be tested in males; 2) programs need to be tested in adolescents of younger age before the typical onset of an ED; and 3) programs need to be possible to administer by non-professionals.

In this study the research group aim to adapt and test the effect of the Body Project, by the pilot study the "Healthy Sport Project", in elite junior athletes attending specialized junior sport high schools (age 14). The final goal for this project group is to create an effective preventive program for body dissatisfaction and DE/EDs in young athletes of both sexes and in mixed sports, and which may be administered by the schoolteachers.

Eligibility Criteria:
Inclusion Criteria:

* pupil at the recruited Sport Jr High School

Exclusion Criteria:

* no informed consent from parents
* not willing to participate
* a diagnosis of an eating disorder and being under (or waiting for) treatment
Study to Assess Clinical Activity of Zelenectide Pevedotin in Participants With Advanced Breast Cancer

This is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with NECTIN4-amplified recurrent, unresectable, or metastatic breast cancer who have received prior therapy (see inclusion criteria below). The study will comprise of 2 cohorts. Cohort A will include participants with hormone receptor positive/ human epidermal growth factor receptor 2 negative \[HR+/HER2-\] breast cancer, whereas Cohort B will include participants with triple-negative breast cancer (TNBC).


Eligibility Criteria:
Inclusion Criteria

* Archival or fresh tumor tissue comprised of recurrent unresectable or metastatic TNBC or HR+/HER2-negative breast cancer available for NECTIN4 gene amplification testing.
* Confirmed NECTIN4 gene amplification by an analytically validated clinical trial assay.
* Measurable disease as defined by RECIST v1.1.
* Life expectancy ≥ 12 weeks.
* Eastern Cooperative Oncology Group Performance Status of ≤ 2.
* Cohort A Specific Inclusion Criteria: Histologically or cytologically confirmed HR+/HER2-negative endocrine resistant/refractory breast cancer according to ASCO-CAP guidelines and received up to 3 prior lines of non-endocrine therapy for advanced disease.
* Cohort B Specific Inclusion Criteria: Histologically or cytologically confirmed TNBC, including ER-low positive breast cancers (1-10% of cells expressing hormonal receptors by IHC), according to ASCO-CAP guidelines and have received at least 1 but no more than 3 prior lines of systemic therapy for advanced disease.

Exclusion Criteria

* Prior treatment with any antibody drug conjugate containing an Monomethyl Auristatin E (MMAE) (vedotin) payload or other MMAE-based therapy.
* Known hypersensitivity or allergy to any of the ingredients of any of the study interventions or MMAE.
* Previously tested HER2-positive (IHC 3+ or ISH+) on prior pathology testing (per ASCO-CAP guidelines).
* Active keratitis or corneal ulcerations.
* Active or untreated CNS metastases.
* Uncontrolled diabetes or hypertension.
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent draining procedures (monthly or more frequently).
* Active interstitial lung disease or penumonitis requiring ongoing treatment with steriods (\>10mg/day of prednisone or equivalent) or other immunosupressive medications.
* Requirement, while on study, for treatment with strong inhiitors or strong inducers of human cytochrome P450 3A (CYP3A) or inhibitors of P-glycoprotein (P-gp) including herbal- or food-based inhibitors.
* Prior treatment with any systemic anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to first dose of study treatment

Note: Additional protocol defined Inclusion/Exclusion criteria apply
The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients

This study was a randomized controlled trial study. The aim of this study was to determine the effect of soursop fruit supplementation on blood pressure (BP), serum uric acid (SUA), and kidney function.

The definition of prehypertension and hypertension was accepted as delivered in The Seventh Report of the Joint National Committee (JNC 7) as the systolic BP was 120 - 139 mmHg and diastolic BP was 80 - 89 mmHg for prehypertension, while systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg for hypertension.

Based on the study by Sja'bani (2014), the cut-off point of (SUA) was divided into 3 categories, which are normal (\< 5 mg/dL), high-normal (5 - \<7 mg/dL), and high (≥ 7 mg/dL).

A number of 143 people with essential prehypertension and high normal uric acid level were assigned as subject in this study. Subjects were randomly assigned into two groups which are treatment and control group. For a 3 months period, the treatment group was given 2x100 g soursop fruit juice per day and the control group was left without treatment.

Blood pressure was measured by medical team using Omron HEM-907 (digital automatic blood pressure monitoring) every 2 weeks (3 times readings for each) in each subject's home. Subjects were examined in sitting position. Evaluation of laboratory examination was taken at week 0, 7 and 13.


Eligibility Criteria:
Inclusion Criteria:

1. pre-hypertensive patients in accordance with JNC 7 (Joint National Committee 7) criteria,
2. male or female resident in Mlati, Sleman with or without family history of hypertension,
3. age 30-59 years,
4. high normal uric acid levels (≥ 5 and \< 7 mg/dL) and
5. agreed to follow the study by giving their informed consent.

Exclusion Criteria:

1. have a history of diabetes, chronic renal failure,
2. using hormonal contraceptive,
3. in pregnancy,
4. taking uric acid-lowering drugs (allopurinol, probenecid),
5. positive urine reduction, positive proteinuria, creatinine \> 1.5 g/dL, Blood Glucose \> 126 g/dL.
Does Autologous Conditioned Plasma Enhance Rotator Cuff Tendon Healing After Surgery?

The aim of this study is to establish if the application of autologous conditioned plasma (ACP), also described as platelet rich plasma (PRP), to the site of supraspinatus tendon repair beginning within two weeks of surgery, can improve patient outcomes over the course of 12 months. These outcomes will be measured by post-surgical pain and function scores, shoulder strength and range of motion (ROM), and radiological parameters of tendon healing. Outcome measures will be compared to a control group of patients receiving placebo injections following surgery (saline plus local anaesthetic).

This study is significant for being the first double blind randomised control trial, using two PRP injections to examine the efficacy of a PRP preparation following surgical repair of supraspinatus tendon. The objective is to prolong and enhance the tendon healing response initiated by surgery.

The research hypothesis is that enhanced tendon healing following the PRP injections will lead to more rapid rehabilitation and lower rates of re-rupture of the repaired tendon compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Aged 50-75 years;
* In a non-dependent relationship;
* Full-thickness supraspinatus tendon tear (deemed repairable);
* Pre-operative platelet count greater than 150 000.

Exclusion Criteria:

* Previous rotator cuff repair surgery;
* Active/distal infection;
* Metabolic bone or blood disorders;
* Pre-existing conditions associated with upper extremity pain;
* Rotator cuff tears secondary to fracture;
* Prior ACP/PRP injections;
* Non-surgical rotator cuff treatment in the past month, including corticosteroids and anti-inflammatory treatment.
Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease

Sleep apnea is common among Veterans with cerebrovascular disease (stroke or transient ischemic attack \[TIA\]), leads to hypertension, and is associated with recurrent stroke and death. Although continuous positive airway pressure (CPAP) safely treats sleep apnea, few Veterans with cerebrovascular disease are diagnosed with sleep apnea or offered treatment.

The project sought to evaluate whether a diagnostic and therapeutic intervention strategy among Veterans with cerebrovascular disease and hypertension using unattended polysomnography and auto-titrating CPAP with a targeted adherence evaluation and educational protocol resulted in: an improved rate of diagnosed sleep apnea, an improved rate of treated sleep apnea, and improved blood pressure control.

Eligibility Criteria:
Inclusion Criteria:

Stroke or Transient Ischemic Attack Hypertension

Exclusion Criteria:

* Prior diagnosis of sleep apnea or other sleep disorder
* Life expectancy \< 6 months or Hospice
* Non-English speaker
* Unable/unwilling to use mask
* Inability to give informed consent
* Oxygen dependent COPD
* Chronic renal failure with dialysis
* Active Suicidal Ideation