cyrilzakka/clinical-trials huggingface dataset:
Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-2)

Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in stroke patients undergoing mechanical thrombectomy. The purpose of this study is to further determine the efficacy and safety of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture;
3. Previous mRS ≤ 2;
4. Baseline NIHSS ≥ 6;
5. Baseline ASPECTS ≥ 6;
6. Unilateral middle cerebral artery occlusion with or without ipsilateral internal carotid artery occlusion;
7. Successful recanalization after mechanical thrombectomy (eTICI 2b-3);
8. Written informed consent provided by the patients or their legal relatives.

Exclusion Criteria:

1. Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia;
2. Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
3. Complications related to thrombectomy, such as contrast agent extravasation, vascular perforation/rupture, dissection, and escape of thrombus;
4. Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy;
5. \> 2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy;
6. Patients with contraindications to MRI;
7. Other conditions that the investigator considered inappropriate for inclusion.
Effect of Body Position Changes on Endotracheal Tube Cuff Pressure in Ventilated Critically Ill Patients

The endotracheal tube secures free airway in patients undergoing surgical procedures or mechanical ventilation. The extraluminal airway needs to be sealed by a cuff. The cuff needs to be adequately inflated with air. The cuff pressure should be between 20 and 30 cm H2O. A cuff pressure in excess of the target range is associated with a risk of tracheal injury, whereas a cuff pressure below the lower limit includes a risk of micro-aspiration of subglottic secretions, with risk of subsequent ventilator-associated pneumonia. It is unknown whether the cuff pressure changes following changes in body position of the patient. The objective of this study is to investigate to which extent - if any - cuff pressures change after body position changes of the patient.


Eligibility Criteria:
Inclusion criteria are age 18 - 70 years, oral intubation with a taperguard EVAC endotracheal tube (Covidien®), conventional mechanical ventilation, adequate sedation (Richmond Agitation-Sedation Scale -5) and analgesia (Behavior Pain Scale 3 to 4).

Exclusion criteria are factors with potential influence on the cuff pressure or factors that disturbed the safety or well-being of the patient: pregnancy, palliative care, difficult intubation, decreased mobility of the neck, history of neck surgery, temperature of \<35°C or \>37.5°C, morbid obesity (body mass index \>35) and every potential contra-indication for position changes such as unstable spinal cord injury or hemodynamic and/or respiratory instability.
Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)

Assess the impact of eplerenone (initiated within 2 hours prior to patient departure to the operating room and administered for 4 days during the post-operative period) on graft function evaluated by the measurement of glomerular filtration rate at 3 months - variable strongly associated with long-term graft survival.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age
* Informed consent
* Candidate for a single or a dual kidney transplantation from an expanded criteria deceased donor ( 60 years or older or age between 50 and 59 with 2 of the 3 following criteria: cardiovascular death, history of hypertension, serum creatinine above 130µmol/L), regardless of machine perfusion and graft rank
* Chronic hemodialysis
* Affiliated to a social security system

Exclusion Criteria:

* Multiple organ transplantation (kidney and liver, kidney and heart, kidney and pancreas, kidney and lung, kidney and intestine)
* Patient receiving a graft from a donor under mineralocorticoid receptor antagonist treatment (spironolactone or eplerenone)
* Peritoneal dialysis
* Preemptive transplantation
* Hypersensitivity or known allergy to Eplerenone or one of its excipients
* Patients with severe hepatic insufficiency (class Child-Pugh C)
* Patient receiving powerful CYP3A4 inhibitors (for example itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycyn and nefazodone)
* Hypersensitivity or known allergy to iodinated contrast agents (iohexol)
* Demonstrated thyrotoxicosis
* Hypersensitivity to lactose
* HLA desensitization prior to renal transplantation
* Pregnant woman or woman without effective contraception
* Patient under judicial protection
* Patient under legal guardianship
* Participation in another biomedical study
1% Lidocaine Paracervical Block for Endometrial Biopsy

The objective of this study is to determine whether 1% lidocaine paracervical block reduces pain during endometrial biopsy in comparison to sham paracervical injection with normal saline or no intervention.

The proposed study is a double-blind, triple arm, placebo-controlled randomized controlled trial (RCT). Each participant will be randomly assigned to one of three arms:

1. intervention (paracervical block - 10 cc 1% lidocaine with epinephrine)
2. placebo (10 cc paracervical injection of normal saline)
3. control (gently tapping the cervicovaginal junction with a capped needle)

The primary outcome will be a global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) following the procedure.


Eligibility Criteria:
Inclusion Criteria:

* = or \> 18 years old presenting for endometrial biopsy
* All parities
* English-speaking participant

Exclusion Criteria:

* Use of pain medication that is not non-steroidal anti-inflammatory (NSAID) or acetaminophen in the past 24 hours
* Confirmed pregnancy
* Any diagnosed chronic pain syndromes
* Contraindication to lidocaine
* Misoprostol administration within 24 hours
* Previous unsuccessful office attempt of endometrial biopsy by same practitioner
Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris

The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
* Must have ≥ 25 but ≤ 100 non-inflammatory lesions (open and closed comedones) AND ≥ 20 but ≤ 70 inflammatory lesions (papules and pustules) AND ≤ 2 nodulocystic lesions (nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) at Baseline.
* Must be willing and able to refrain from use of all other topical products in the treatment area, all acne medications other than test article, and all antibiotics (other than test article) during the 12-week treatment period.
* Women must be surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit (Day 1).
* In good general health and free of any other clinically significant disease state or physical condition.
* Subject has provided written informed consent / assent.

Exclusion Criteria:

* Subject is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during the study.
* Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
* Subject has excessive facial hair (e.g., beards, sideburns, moustaches), facial tattoos, or other facial attributes that would interfere with diagnosis or assessment of acne vulgaris in the opinion of the investigator.
* Subject is planning surgery during the study.
* Subject has a history of hypersensitivity or allergy to clindamycin or lincomycin and/or any of the ingredients in the test articles.

Other Eligibility Criteria not listed above will be reviewed for each prospective subject by the study staff.
Survey of Running Following a TKA

The hypothesis of this study is that there are people running following a total knee arthroplasty (TKA).

The objective is (1) to determine if there are people that ran/run following their TKA and (2), in case (1) is true, to identify some general running parameters such as duration, frequency, perceived barriers for running.

Patients with a TKA and a score equal or higher than 9 on the UCLA activity scale at any time between 2 years prior to surgery and at present will be invited to participate in the trial by phone. All these patients will receive the study's information form and questionnaire by post with a pre-stamped envelope to return the documents.The survey was created and piloted internally for this study. There are 21 questions, most of them are "yes or no" and some others open questions to assess parameters such as duration of difficulties faced. The questionnaire is composed of three parts. The first part is interested in the preoperative activity (during the 2 years before surgery), the second part in the postoperative activity (during the 2 years after surgery) and the third part refers to the current practice. For each part, people are asked about specific practice parameters and modalities. Furthermore, we seek to determine whether there was/is a willingness to run following TKA, if patients receive any education/information about it and their personal attitudes towards running with a TKA. The anonymized data will be collected by the main author for subsequent analysis.


Eligibility Criteria:
Inclusion Criteria:

* TKA and UCLA score = or \> 9

Exclusion Criteria:

* Inability to read/write in french language
* Cognitive or neurological impairment
ATAC - Pharmacokinetics (PK) Sub-Protocol

To assess the effect of ARIMIDEX on the pharmacokinetics of tamoxifen and the effects of tamoxifen on the pharmacokinetics of ARIMIDEX..


Eligibility Criteria:
Inclusion Criteria:

* Eligible for entry into the main ATAC trial 1033IL/0029
* Patients must have been taking ATAC trial medication for at least 3 months (i.e. patients must have reached at least visit 2 of the main ATAC study)
* Patients should be taking their medication in the mornings for at least 3 months
* Patients must be 100% compliant over the preceding fourteen days

Exclusion Criteria:

* Excluded from entry into the main ATAC trial (1033IL/0029)
* Patients whose concurrent treatment includes diazepam or drugs which might affect tamoxifen steady state levels or steroid hormone status. These include ketoconazole (antifungal) or related compounds
Post -Extubation Respiratory Failure

comparing high flow nasal cannula , conventional oxygen tharapy and non invasive ventilation post-extubation period for patients mechanically ventilated due to respiratory failure regarding re-intubation rate, ICU outcome \& 28 days mortality

patients with respiratory failure either type I or type II planned for extubation will be divided into 3 groups post extubation :

Group I: will receive high flow nasal cannula giving oxygen 60 litres / minute flow group II: will receive nasal cannula up to 10 litres / minute group III: will receive non invasive ventilation

Data of the patients will be collected for 28 days post-extubation and analysed

Eligibility Criteria:
Inclusion Criteria:

* respiratory failure type I and Type II

Exclusion Criteria:

* Mechanical ventilation due to other cause such as disturbed conscious level or respiratory muscle weakness
Randomized, Double-masked, Sham-controlled Phase 4 Study, Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy in Patients With Polypoidal Choroidal Vasculopathy

The purpose of this study is to compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept plus standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy (PCV).

To compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept associated with standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy (PCV) in a proof concept study and to identify genetic biomarkers for the diagnosis and treatment response of PCV in Caucasians.

Eligibility Criteria:
Inclusion Criteria:

* Either gender and Age ≥ 50.
* Naïve PCV patients.
* Confirmed diagnosis of symptomatic macular PCV in the study eye.
* Greatest linear dimension of the lesion of \< 5400 mm, assessed by ICG angiography.
* BCVA at study entry of 25 to 80 letters (Snellen Equivalent 20/320 to 20/25).
* Lesion size in the study eye at study entry:
* Presence of PCV assessed by the Central Reading Centre based on ICG with active polyps with or without abnormal vascular network.
* Women must be using effective contraception, be post-menopausal for at least
* months prior to trial entry, or surgically sterile.
* Ability to provide written informed consent.
* Ability to return for all study visits.

Exclusion Criteria:

* Active inflammation or infection in the study eye.
* Uncontrolled intraocular pressure in the study eye.
* Ocular condition in the study eye which may impact vision and confound study outcomes (e.g. vitreomacular traction, epirretinal membrane with BCVA impact, ocular inflammation, retinal vascular diseases like diabetic retinopathy or diabetic macular edema).
* Presence of centromacular scarring or atrophy indicating irreversible BCVA loss.
* Prior treatment of the study eye with anti-VEGF therapy or systemic use of anti-VEGF products within 3 months prior to the study entry.
* Previous vitrectomy, macular laser treatment, PDT, or intraocular steroids in the study eye.
Postextubation Management in Patients at Risk for Extubation Failure

At the time of weaning from mechanical ventilation, patients with heart and/or lung conditions will be given oxygen support with alternating bilevel positive airway pressure (BiPAP; oxygen via face mask) and heated high flow nasal cannula oxygen (HFNC; oxygen via nasal cannula) to see if this method reduces the likelihood of re-intubation.

It is clinically challenging to predict when patients can be successfully removed from mechanical ventilation (MV). Liberating high-risk patients such as the elderly and those with complex, chronic cardiac or pulmonary diseases from MV is particularly challenging.

Evidence from randomized trials and meta-analyses suggests that the type of postextubation supportive care provided, such as oxygen delivery via nose or mouth, may affect the risk of reintubation. However, it is unclear which of many possible postextubation management protocols results in the best patient outcomes, particularly for this subset of high-risk patients.

The purpose of this study is therefore to assess a standardized combined protocol of postextubation oxygen delivery consisting of early, alternating BiPAP with HFNC over 24 hours following extubation. BiPAP and HFNC are both currently provided to patients as standard of care, based on clinician judgement; however, the timing and nature of the methods are variable.

Eligibility Criteria:
Inclusion Criteria:

* Documented high-risk factors of interest \[congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), and/or positive fluid balance\]
* The modified rapid shallow breathing index on day of extubation must be between 58-105 breaths per minute per liter (breaths/min/L)
* Patient must successfully complete spontaneous breathing trial and be determined eligible for extubation
* Only primary extubations will be included

Exclusion Criteria:

* Undergoing terminal extubation or placed on comfort care
* Home ventilator use
* Any contraindication that would preclude the postextubation protocol (e.g., facial trauma, tracheotomy, or any other reason that would preclude use of BiPAP or HFNC)
Candesartan in Peripheral Neuropathy

Background:

Chemotherapy induced peripheral neuropathy (CIPN) is often painful, and is caused by neurotoxic chemotherapy including vincristine. It is a cause of significant impairment in quality of life in patients surviving to a solid cancer or malignant lymphoma. The only recognized prevention is based on pre-existing neuropathy and early detection of neuropathic signs and symptoms in individuals subjected to neurotoxic chemotherapy, justifying sometimes a change in the therapeutic strategy when other molecules are available. It seems obvious that to identify early markers of CIPN and to develop preventive therapeutic strategies, are priorities for improving patients' quality of life and enable them to follow optimal treatment.

Purpose:

To describe in patients treated for non-Hodgkin's type B malignant lymphoma with multidrug therapy containing vincristine, the impact of candesartan on the occurrence of neuropathy measured by the variation of TNSc (Total Neuropathy Score clinical version, evaluating clinical signs of neuropathy)


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and over and to be treated with Vincristine for non-Hodgkin B lymphoma (first line treatment)
* All the patients have to be treated with the same chemotherapy protocol (CHOP with or without Rituximab) to avoid confounding factors
* Normal renal function as measured by CKD-EPI \> 30 mmol / min / 1.73 m2
* Serum potassium \< 5.5 mmol / l
* Systolic arterial pressure \> 100 mm Hg (lying and standing position)
* affiliated with a social security
* For women of childbearing age: under "highly effective" contraception and negative pregnancy test at inclusion. Highly effective contraception:

  * Combined hormonal contraceptive (containing estrogen and progesterone) (oral, intravaginal, or transdermal) or only progesterone (oral, injectable or implantable),

Exclusion Criteria:

* Patients with pre-existing neuropathy, Chronic ethylism, HIV infection, etc.
* Patients under guardianship or unable for another reason to give informed consent.
* Intolerance to sartans
* Intolerance to excipients : galactose , lactose.
* Patients already treated with ACE inhibitors, ARBs or/and diuretics sparing
Complicated Grief in ICU in the Aftermath of COVID-19

An increased proportion of deaths occur in the intensive care unit (ICU). Some amenable factors such as end-of-life practices may contribute to complicated grief.

Because of the COVID-19 pandemic, visitor restrictions in health care facilities have been implemented. Families were also unable to implement usual funerals. The investigators hypothesize that these policies and practices may impact grief during covid-19 pandemic. The aim of this study is to evaluate the prevalence of complicated grief after death of a relative in the ICU during the COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

* adult relative (\>18 years)
* adult relative from patients who died in ICU after SARS-COV-2 infection

Exclusion Criteria:

* adult relative (\<18 years)
The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance

This research study is designed to develop and test a new supportive care program to help individuals with lung cancer improve their quality of life after cancer treatment is over.

The aims of this pilot study are to evaluate the feasibility and acceptability of a brief psychoeducational intervention for participants with cancer who are transitioning from active treatment to surveillance.

The research study procedures include screening for eligibility.

This study consists of 2 parts. It is expected that about 45 people will take part in this research study.

* In the first part of this study, about 5 participants will complete survey questions and receive a 5-session program.
* In the second part of this study, about 40 participants will complete 3 surveys, and then will be randomly assigned to receive the 5-session program or to receive one study session (control).
* These sessions will focus on providing targeted support related to life after cancer treatment. The sessions will focus on skills for coping with uncertainty, managing symptoms, improving social support, and other topics important to the individual.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 or older
* Diagnosis of non-small cell (NSCLC) or small cell (SCLC) lung cancer or mesothelioma
* Documented treatment plan with curative intent
* Ability to read and respond in English
* Treatment completion eligibility:

Run-in: Has completed treatment including systemic treatments and radiation as determined within the past three weeks by the cancer care team at Massachusetts General Hospital.

RCT: Has completed treatment including systemic treatments +/- radiation and +/- surgery.

1. If final treatment is systemic therapy +/- radiation: within three weeks after cancer care team determination that treatment is complete.
2. If final treatment is surgery: within three weeks after hospital discharge following surgery.

Exclusion Criteria:

* Comorbid health condition that would interfere with study participation
* Current participation in cognitive behavioral therapy treatment
Investigation of the Effectiveness of Whatsapp-Based Physical Activity Incentive Program in Morbidly Obese Individuals

The limited number of studies on the effectiveness of physical activity incentive programs for morbidly obese individuals in the literature shows the need in this area.

In this study, primary aim is to investigate the effect of physical activity incentive program applied through face-to-face and whatsapp-based applications on physical activity level, functional capacity and muscular endurance in morbidly obese individuals.

Secondary aim is to provide individuals with exercise habits and to ensure participants' sustainability with the physical activity incentive program planned in line with the needs of the individual.


Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18-60
* BMI ≥40 kg/m2, morbidly obese awaiting bariatric surgery
* No surgical operation in the last 6 months

Exclusion Criteria:

* Having a musculoskeletal disorder or systemic disease that will interfere with physical activity
* Presence of balance problems that will prevent physical activity
* Presence of psychiatric or neurological disease affecting cooperation and cognitive functions
* Presence of acute pain
* Heartache
* Having a history of myocardial infarction
* Presence of conjunctive heart failure
* Presence of uncontrolled diabetes and hypertension