cyrilzakka/clinical-trials huggingface dataset:
The Impact of Aortic Valve Compression During Cardio-pulmonary Resuscitation on Patients With Out-of-hospital Cardiac Arrest

Purpose:

This study aims to find out if the current way of performing chest compressions during resuscitation for patients who have suffered a cardiac arrest outside of the hospital is affecting their chances of recovery. Recent research suggests that more than half of these patients receive chest compressions near their aortic valve, which might block blood flow and make their condition worse. We will use a special imaging technique called transesophageal echocardiography (TEE) during resuscitation to see if compressions near the aortic valve impact patient outcomes.

Methods:

We will conduct a study with patients who have suffered a cardiac arrest outside of the hospital and are receiving TEE during resuscitation in the emergency department. Some patients will not be included in the study, such as those who recover quickly before the TEE is done, those who need other treatments before they recover, those with an unclear compression site, or those with poor or missing TEE images. We will divide the patients into two groups: those with compressions near their aortic valve and those without. We will collect information on the patients, the TEE recordings, the resuscitation process, and important time points. We will mainly look at whether the patients recover and maintain a steady heartbeat. We will also examine other factors like their carbon dioxide levels, whether they recover at all, if they survive to be admitted to the hospital, if they survive to be discharged, and if they have good brain function when they leave the hospital. We plan to have 37 patients in each group for accurate results.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 20 or older who arrived at the ED with non-traumatic OHCA and underwent TEE during resuscitation

Exclusion Criteria:

1. Early ROSC before obtaining TEE image;
2. Insert the REBOA before ROSC;
3. Initiate ECMO flow before ROSC;
4. Cannot identify compression site on TEE;
5. Poor quality of TEE image;
6. Missing TEE image.
Clinical Study of CT 5400 RT for Precise Image Validation

The purpose of this study is to evaluate the effectiveness of the Precise Image (PI), an AI feature of CT 5400 RT System


Eligibility Criteria:
Inclusion Criteria:

* 30 image raw data generated from CT 5400 RT system validation clinical trial (protocol name: Clinical study of CT 5400 RT for system validation, ClinicalTrials.gov ID: NCT06466577)
* Applicable body parts include: head, neck, chest, abdomen and coronary

Exclusion Criteria:

* Raw data is considered inappropriate for inclusion
Consumption of Chocolate in Pregnant Women.

The purpose of this study is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelium function in pregnant women at high risk for preeclampsia.

Although numerous strategies have been studied, no effective prevention or treatment of preeclampsia is yet available for pregnant women. This is surprising considering the growing body of literature that supports the hypothesis of a beneficial effect of dark chocolate consumption through the activity of flavanols on the endothelial function and blood pressure regulation, to find any clinical data among pregnant women with preeclampsia.

The primary objective of the trial is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelial function in pregnant women at high risk of preeclampsia. This 12-week efficacy study will permit us to verify the sustainability of the effect of daily intake of flavanol-rich chocolate intake.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between the ages of 18 and 40 years.
* Presence of uterine diastolic notches measured by uterine artery Doppler between 10 and 14 weeks.

Exclusion Criteria:

* Hypertension requiring medication.
* Currently or previously use of medications interfering with glucose or lipids metabolism.
* Use of supplements or natural health products that interfere with blood pressure.
* Consumption of 1 or more alcohol drink per day.
* Allergy or intolerance to nuts or chocolate.
Pulmonary Vascular Dysfunction as a Cause of Persistent Exertional Dyspnea After Coronavirus Disease (COVID-19)

To identify pulmonary vascular disease in post/long-COVID-19 patients as a cause of dyspnea/exercise limitation and to differentiate it from other causes of dyspnea

The aim is to identify pulmonary vascular disease in post/long-COVID-19 patients as a cause of dyspnea/exercise limitation and to differentiate it from other causes of dyspnea (muscular, left cardiac, psychological, deconditioning-related causes) by investigating ventilation-perfusion (V/Q) mismatch and (exercise-induced) pulmonary hypertension (PH) or right heart dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, patients with a suspected diagnosis of post/long-COVID-19 syndrome who present to our pneumology or infectious disease outpatient clinic or corresponding ward from the start of the study and whose SARS-CoV-2 infection was diagnosed at least 3 and not longer than 18 months prior to presentation
* Patients at least 3 and not longer than 18 months after a SARS-CoV-2 infection without post/long-COVID-19 syndrome who present to our post-infection outpatient clinic for follow-up

Exclusion Criteria:

* Patients who refuse to participate in the study
* Severe underlying chronic pulmonary, cardiac, or systemic disease (e.g., Chronic obstructive pulmonary disease (COPD), severe heart failure, neuromuscular disease) that was diagnosed prior to acute COVID-19 disease and whose progression appears likely as the cause of dyspnea
* Other non pneumologic causes of dyspnea (e.g., hemoglobin \< 100 g/L)
* Unstable or acute disease (e.g., acute infection, acute renal failure, acute coronary syndrome)
* Inability to perform spiroergometry, including transient orthopedic problems, contraindications to central venous and arterial catheter placement (e.g., severe bleeding tendency).
Evaluation of the Healthy Relationships Plus Program for Youth

Adolescent risk behaviours, such as violence and substance use, are prevalent public health concerns in Canada. Further, these behaviours often co-occur, and are associated with poor mental health. However, the majority of prevention programs focus on preventing single issues and do not consider mental health, and also neglect the importance of relationships when promoting positive youth development. To address this gap, the Centre for Addiction and Mental Health (CAMH) Centre for Prevention Science designed the Fourth R Healthy Relationships Plus Program, a small group program focused on the promotion of positive mental health and the reduction of violence and substance use, via the development of improved communication, interpersonal and help-seeking skills. The purpose of this study is to evaluate the Fourth R Healthy Relationships Plus program using both outcome (randomized controlled trial design with follow-up at pre-test, post-test, and 4, 8 and 12 months) and process evaluation tools.

The primary study hypothesis is that participation in the Fourth R Healthy Relationships Plus program will be associated with positive growth in treatment participants' psychological well-being from pre-test to 12-month follow-up, as compared to control participants. In secondary analyses, the study will explore if treatment participants report less substance use, peer violence, bullying and dating violence at 12-month follow-up than control participants. Since certain person-level (e.g., sex, personality, executive functioning) and program-level (e.g., implementation quality) variables may moderate treatment-outcome relationships, these associations will also be explored. The final hypothesis is that treatment participants will report better attitudes, knowledge and assertive communication at post-test compared to control participants, and that these improvements will mediate the association between program participation and 12-month outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled (as of March 2014) in grade 9 or 10 at schools serving as study sites

Exclusion Criteria:

* Not available during the period July 7-17, 2014 (the main study period)
* Not interested in participating in the project, as assessed on study information form
* Identified by the Guidance Office at his/her school as posing a serious safety risk to him/herself or others
Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer

The primary objective of this study is to assess the activity of subcutaneous (SC) amifostine on the incidence and severity of acute radiochemotherapy-induced esophagitis in patients with unresectable Stage IIIA or IIIB non-small cell lung cancer (NSCLC) receiving combined modality therapy.


Eligibility Criteria:
You may be eligible for this study if you are 18 years of age or older and:

* Have UnResectable Stage IIIA or IIIB Non Small Cell Lung Cancer
* Have never had prior chemotherapy with Paclitaxel or Carboplatin
* Have never had prior thoracic radiation therapy (XRT)
A Study to Evaluate SAGE-217 in Participants With Essential Tremor

This study is a three-part, multicenter, Phase 2a study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of SAGE-217 in adult participants with essential tremor.

Part A of the study was an open-label design with morning dosing of SAGE-217 for 7 days and included 16 participants, 8 of whom qualified for, and entered, Part B.

Part B had a double-blind, placebo-controlled, randomized withdrawal design with morning dosing for 7 days.

Part C was an open-label design with morning and evening dosing for 14 days and included a different set of 18 participants.

Parts A and B were stopped early (in advance of the planned sample size).

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

* Participant must have a diagnosis of Essential Tremor (ET), defined as bilateral postural tremor and kinetic tremor, involving hands and forearms, that is visible and persistent and the duration is \>5 years prior to screening.

Key Exclusion Criteria:

* Participant has presence of abnormal neurological signs other than tremor or Froment's sign.
* Participant has presence of known causes of enhanced physiological tremor.
* Participant has concurrent or recent exposure (14 days prior to admission visit) to tremorogenic drugs.
* Participant has had direct or indirect trauma to the nervous system within 3 months before the onset of tremor.
* Participant has historical or clinical evidence of tremor with psychogenic origin.
* Participant has convincing evidence of sudden tremor onset or evidence of stepwise deterioration of tremor.
Acute Post-operative Pain in Colon Resections

Objective of the study is to compare three different analgesic techniques in patients undergoing laparoscopic colon resections: peridural catheter, patient controlled analgesia of endovenous morphine and patient controlled analgesia of sufentanil sublingual tablets.

159 patients undergoing laparoscopic colon resections will be enrolled and randomized in three different groups.

Patients in the first group will be subjected to the positioning of a peridural catheter with a continuous infusion of ropivacaine 0,2%99 ml+sufentanil 50 mcg at an infusion rate of 4-6 ml/h.

In the second group participants will receive an intraoperative bolus of morphine (0,05mg/kg) and post-operatively a patient controlled analgesia of endovenous morphine (injection dose 1 mg,lock-out 10 minutes,maximum morphine dosage for hour 4 mg).

In the third group the investigators will adopt an intraoperative bouls of morphine (0,05mg/kg) and post-operatively a patient controlled analgesia of sufentanil sublingual tablets( 15 mcg, lock-out 20 minutes)

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 Patients undergoing laparoscopic colon resections/ Acceptance informed consent

Exclusion Criteria:

* Contraindications to the positioning of a peridural catheter/ Previous allergic reactions to the drugs used in the study/ inability of using patient controlled analgesia system
Exercise Treatment With Standard Therapy for Metastatic Breast Cancer

This study will test any good and bad effects of aerobic exercise performed while you are receiving the usual first-line treatment for metastatic breast cancer. The researchers think that exercise helps delay the development of resistance to hormone therapy while slowing the growth of tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically-confirmed, HR-positive (ER and/or PR), HER2-negative metastatic breast cancer (MBC)
* Postmenopausal status defined by lack of menses for 2 years, oophorectomy, or medical ovarian suppression
* Receiving first line endocrine-based therapy (tamoxifen, aromatase inhibitor, or fulvestrant; concurrent molecular therapy also allowed)
* Sedentary (i.e., \<60 minutes / week of exercise)
* Age \>18 years
* BMI ≥ 18.5
* Cleared for exercise participation as per screening clearance via PAR-Q+
* Cleared for study participation as per screening consultation with an MSK Exercise Physiologist
* Willingness to comply with all study-related procedures
* Patients with "treated and stable" brain lesions of a duration of ≥ 2 months may be enrolled

Exclusion Criteria:

* Life expectancy \<6 months
* Enrollment onto any other therapeutic investigational study
* Mental impairment leading to inability to cooperate
* Concurrent participation in weight loss or other exercise programs
Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder

The investigators will compare 3 treatment groups (ketamine plus naltrexone vs. ketamine alone vs. placebo) for treating major depressive disorder (MDD) and alcohol use disorder (AUD) in an 8-week randomized, double-blind, placebo-controlled, between-subjects trial. First, prior to the double-blind trial, the investigators will conduct an open-label trial that will include 5 patients with comorbid MDD and AUD to test safety and efficacy of repeated ketamine treatment (0.5 mg/kg; once a week for 4 weeks; a total of 4 ketamine infusions) with a follow-up of 4 weeks. Second, after reviewing the safety and efficacy of repeated ketamine treatment from the open-label trial, the investigators will conduct an 8-week, randomized, double-blind, placebo-controlled trial that will include 60 patients with comorbid MDD and AUD to test safety and efficacy of repeated ketamine treatment (0.5 mg/kg; once a week for 4 weeks; a total of 4 ketamine infusions) plus naltrexone with a follow-up of 4 weeks. The 4-month follow-up session will also occur.


Eligibility Criteria:
Inclusion Criteria:

* Male or female veterans and civilians, 21-65 years old
* Current major depressive disorder without psychotic features by DSM-5 (antidepressant regimens can be allowed and changed during the trial)
* Montgomery-Asberg Depression Rating Scale (MADRS) 20 or higher
* A minimum of 4 of 11 current alcohol use disorder symptoms by DSM-5
* Heavy drinking at least 4 times in the past month ('heavy drinking' defined as 5 standard drinks per day for men and 4 standard drinks per day for women
* Able to provide written informed consent

Exclusion Criteria:

* Current substance use disorder by DSM-5 in the past 3 months (except alcohol, tobacco, or cannabis)
* Current or past history of psychotic features or psychotic disorder
* Current dementia
* Current uncontrolled hypertension (systolic BP \> 170 mm Hg or diastolic BP \> 100 mm Hg)
* Unstable medical condition or allergy to ketamine, midazolam, naltrexone, or lorazepam---clinically determined by a physician
* Imminent suicidal or homicidal risk
* Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential
* Positive opioid or illicit drug screen test (except marijuana)
* Opioid use within 10 days prior to study medication (injectable naltrexone) or risks for opioid use during the study
* Liver enzymes that are three times higher than the upper limit of normal
* Current use of benzodiazepine
* Acute narrow-angle glaucoma
* Severe sleep apnea---clinically determined by a physician
Safety and Effectiveness of the PXL-Platinum 330 System

To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.

Patients with progressive keratoconus, pellucid marginal degeneration, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure, and pachymetry.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, history of radial keratotomy with fluctuating vision, Terrien's marginal degeneration.
2. Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
3. Must be willing and able to return for scheduled treatment and follow-up examinations for the duration of the study.
4. Must be at least 8 years of age.
5. Non-consenting/impaired individuals with a LAR's signature

Exclusion Criteria:

1. Corneal thickness \< 300 microns measured by ultrasound or Pentacam.
2. Contraindications or sensitivities to any study medications or their components.
3. Pregnancy or breastfeeding.
4. Any history of Herpes simplex corneal disease in an eye to be treated.
5. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.
6. Inability to cooperate with diagnostic tests.
7. Current enrollment in another ophthalmic clinical trial.
A Study Looking At the Use of Biomarkers to Provide Early Indication of Acute Kidney Injury in Patients with Sepsis (Limiting AKI Progression in Sepsis)

Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI. Two urinary biomarkers have been identified as early indicators of AKI. The NephroCheck® test is a commercially available test that uses these biomarkers, and this study assesses the use of these in reducing negative clinical outcomes for patients with sepsis-associated AKI. The study will enroll subjects diagnosed with sepsis, including septic shock, who will be randomly assigned to either receive NephroCheck®-guided kidney-sparing and fast-tracking interventions; or to receive current Standard of Care assessment and treatment.

NOTE: Participants are no longer being recruited to this study.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of sepsis or septic shock.
* Admission to the ICU or planned admission to the ICU with an expected stay of 72 hours or more after enrollment in the same hospital.
* Expected to have indwelling urinary catheter placed and kept until at least 48 hours after enrollment.
* Written informed consent.

Exclusion Criteria:

* Women with known pregnancy, prisoners or institutionalized individuals.
* Previous renal transplant.
* Stage 2 or 3 Acute Kidney Injury (AKI) at screening.
* Receiving dialysis (either acute or chronic), or in imminent need of dialysis at enrollment.
* Estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m2.
* Known End Stage Renal Disease (ESRD) or history of active nephrotic syndrome within the last 3 months.
* Known Stage 2-3 AKI within last 2 weeks.
* Terminally ill (defined as expectation of death within 6 months), has a do not resuscitate order that would restrict protocol-required procedures, or is being admitted only for palliative care.
* History of solid organ transplant and receiving calcineurin inhibitors.
* Documented serious allergy (i.e. anaphylaxis) to vancomycin, aminoglycosides, penicillins, or cephalosporins (intravenous or oral).
* Known current serum total bilirubin \> 4mg/dL.
* Subjects already included in an observational study can be co-enrolled in LAPIS. Subjects already included in an interventional study may be enrolled with pre-approval of the sponsor according to the following rules:

  1. Co-enrollment in LAPIS will not be allowed with investigational drug and device studies;
  2. Studies may be allowed if AKI or kidney function is not an endpoint with pre-approval of the LAPIS sponsor;
  3. Co-enrollment in LAPIS will not be allowed if co-enrollment is an exclusion criterion in the other study.
* Subjects with laboratory confirmed COVID-19 infection as the primary reason for hospital admission.

Other protocol-defined inclusion/exclusion criteria may apply.
Safety Study of Renal Function in Patients With Chronic Kidney Failure Taking Lumiracoxib or Diclofenac for Arthralgia

The purpose of this study is to determine whether the use of lumiracoxib in this particular population is associated with a decrease in glomerular filtration rate (GFR) compared to diclofenac; and to compare the magnitude of such impairment, if any, associated with use of lumiracoxib and diclofenac.


Eligibility Criteria:
Inclusion Criteria:

* chronic joint pain, requiring analgesia
* pre-existing chronic kidney injury, stage K/DOQI III (GFR 30 - 59 ml/min)
* in a stable phase of CKD (i.e. not AKI, not hospitalized)
* without contraindications for NSAID therapy
* who have signed an informed consent

Exclusion Criteria:

* having received any NSAID 2 weeks prior to study start
* history of / actual PUD
* patients with ESRD (K/DOQI IV, V or replacement therapy)
* history of hypersensitivity or allergies to any of the treatments
* history of / actual GI bleeding
* with impaired liver function tests
* using ACEI / ARB
Impact of Hip Flexors Isokinetic Strengthening on Gait Capacities in Subacute Stroke Patients

Post-stroke patients often present with gait disorders due to several physical impairments. Hip flexor deficit is one of the more prevalent trouble and is associated with gait capacities. This study aims at evaluating the impact of an isokinetic hip flexors strengthening rehabilitation program in the subacute phase after stroke. Patients will be randomized to an intervention group (isokinetic rehabilitation) or a control group (conventional rehabilitation) and assessed at the end of the rehabilitation program, at 3 and at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from a first ever stroke
* At the subacute phase
* Able to walk at least 10m with or without assistive devices
* Hip flexors strength on the paretic side \> 2/5 (MRC)

Exclusion Criteria:

* Uncontrolled epilepsy
* Contraindications to physical activity (severe arterial hypertension, aortic valvulopathy, severe PAD...)
* History of muscular or joint disorders on the paretic hip
* Subject unable to deliver an informed written consent (due to aphasia, cognitive or psychiatric disorders...)
* Protected persons
* Pregnancy