cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Early Administration of Levetiracetam in the Prevention and Treatment Encephalopathy in Septic Shock: Randomized, Double-blind, Placebo-controlled Trial

Sepsis-associated encephalopathy is associated with high mortality rates and long-term neuropsychiatric disorders. Currently, there is no specific treatment for sepsis-associated encephalopathy. Levetiracetam, a broad-spectrum antiepileptic widely used in intensive care units, has neuroprotective properties. We propose the KiSS study, a multicenter, prospective, randomized, double-blind trial with two arms, evaluating the effect of levetiracetam treatment for seven days during septic shock on the occurrence and duration of sepsis-associated encephalopathy.


Eligibility Criteria:
Inclusion criteria :

* Aged 18 years or older
* Hospitalized in intensive care for less than 96 hours
* Presenting with septic shock evolving for less than 24 hours defined by:

  1. Clinically or microbiologically documented infection and
  2. SOFA score ≥ 2 or an increase in SOFA score ≥ 2 points if organ dysfunction was present before the infection and
  3. Need for vasopressor administration to maintain a mean arterial pressure ≥ 65mmHg and
  4. Lactate level \> 2mmol/L (18mg/dL) despite adequate fluid resuscitation
* Patient's consent, their next of kin consent, or emergency inclusion

Non inclusion criteria :

* Chronic long-term antiepileptic treatment upon admission or patient with uncontrolled seizures
* Chronic or progressive central neurological pathologies of traumatic, inflammatory, vascular, infectious, neoplastic, or degenerative origin, defined by cognitive impairments preventing independent living or an IQCODE score \> 4.5
* Patient with moderate to severe dementia
* Patient with psychiatric history and/or suicide attempts
* Severe head trauma within the past 3 months
* Patients with limitations on active therapies or for whom therapeutic commitment is not maximal
* Patient presenting a prolonged QTc interval on ECG and/or at risk of cardiovascular disease
* Concomitant treatment with Methotrexate during the administration of the investigational treatment
* Allergy to levetiracetam
* Minor patients
* Ongoing pregnancy (blood or urinary βHCG)
* Breastfeeding women
* Patients under guardianship or trusteeship
* Non-affiliation with social security or CMU
* Participation in another interventional trial with a drug that may interact with levetiracetam or may impact the evaluation of KiSS trial outcomes. In case of doubt, please contact the trial's coordinating investigator.
Strengthening Effect on Hamstring's Passive Mechanical Properties

The purpose of this study was to investigate effects of different strengthening methods on hamstring muscle group's passive mechanical properties and to investigate this effect's relation with performance changes in healthy individuals. 42 healthy sedentary male participated in this study. Passive mechanical properties and strength of hamstring and quadriceps muscles, flexibility of hamstring muscles, anaerobic explosive strength, reaction time, agility were measured. Participants randomized evenly into one of three groups; eccentric, concentric and neuromuscular electrical stimulation (NMES). After 8 weeks training period, participants were measured again.


Eligibility Criteria:
Inclusion Criteria:

* being sedentary

Exclusion Criteria:

* Having knee, hip and/or back pain
* Having a cardiovascular condition/disease
* History of previous knee and/or hip surgery
* Having a diagnose of any systemic disease
* History of previous hamstring injury
* Being physically active within last year ( Regular activity at least 3 days a week and continuity of at least 2 months was accepted as being physically active)
Support, Training, and Education for Pain Self-Management Using Podcasts: A Pilot Trial

This randomized Stage 1 pilot trial tests the feasibility of a community health worker (CHW) delivered chronic pain self-management intervention for older adults ("STEP-UP"; Support, Training, and Education for Pain Self-Management - Using Podcasts) in a primary care setting. A total of 40 participants aged 50+ with high-impact chronic pain will be randomized to intervention or control groups. The STEP-UP intervention will feature an educational podcast series teaching core pain self-management skills. Podcasts will be supplemented by sessions with a Community Health Worker taking place at designated times over a 7-week period. The Community Health Worker will guide participants in a modified Patient Priorities of Care approach to help them identify their values and priorities and develop goals that reflect these.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years
* Have a mobile or landline phone
* Report high-impact chronic musculoskeletal pain (defined as pain in muscles or joints for \> 3 months "most days" or "every day" on a scale of never, some days, most days, or every day) AND their pain limited life or work activities over the past 3 months "most days" or "every day"
* Have not participated in another chronic pain self-management intervention in the last 5 years.
* Able to converse comfortably in English

Exclusion Criteria:

* Serious acute illness or hospitalization in the last month;
* Planned major surgery in the next three months that would interfere with program participation (e.g., knee or hip replacement)
* Severe cognitive impairment or other severe physical or psychiatric disorder judged by the study team to pose a significant barrier to participation
Model 4396 Left Ventricular (LV) Lead Study

This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe and effective. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.

This study is a prospective, multi-center, non-randomized design. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has statistical power to show safety at one-month after implant. It also has statistical power to show effectiveness at one-month and three-months after implant.

Eligibility Criteria:
Inclusion Criteria:

* CRT/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications, New York Heart Association (NYHA) III and IV, indicated for implantable cardiac defibrillator (ICD) if CRT-D is implanted, patient consent, geographically stable

Exclusion Criteria:

* LV lead implant attempt in last 30 days, unstable angina or acute myocardial infarction (MI) in past 30 days, coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in past 3 months, contraindicated for transvenous pacing, heart transplant
Beach Tennis And Hypertension Study 2

No studies have investigated the chronic effects of team sports on 24 h ambulatory blood pressure and have assessed the effects of a beach tennis intervention in cardiovascular profile and physical fitness. Based on that, the investigators designed this parallel randomized controlled trial to evaluate the effect of beach tennis training on 24 h ambulatory blood pressure and different physical fitness parameters in individuals with hypertension. The difference between the intervention arms in mean change from baseline in 24 h, daytime and nighttime systolic and diastolic ambulatory blood pressure at 12-weeks is the primary outcome; secondary outcomes are the difference between mean change in office blood pressure as well as cardiorespiratory fitness, muscular strength and power. The investigators anticipate that 12 weeks of beach tennis training will reduce blood pressure when compared to a non-exercising control group. Additionally, our recreational beach tennis intervention will improve all physical fitness components in comparison to the baseline values.

This is a single-center, two-arms, parallel randomized controlled trial with concealed allocation, blinded measurers, with 12 weeks of follow-up analyzed using an intention-to-treat approach.

Participants will be randomly allocated to the beach tennis training intervention (BTT) or to the control group (Con), which will not be submitted to intervention and will be instructed not to engage in any kind of structured physical exercise training and to keep the life activities identified at baseline. The International Physical Activity Questionnaire (IPAQ) will be applied before and after the intervention in order to assess the level of physical activity.

In BTT, supervised beach tennis sessions will be performed two times per week. Each session will be composed of an initial period of 10 min of warm up and technical exercises (i.e., serve, volley, forehand and backhand). After that, 3 games of 10-15 min each (weeks 1-4: 3 × 10 min; weeks 5-8: 3 × 12 min; and weeks 9-12: 3 × 15 min) with an interval of 2 min between each game will be played in pairs (i.e., 2 versus 2). In case of less than 4 participants are able to play at the same time, the games can also be played individually (i.e., 1 versus1). In Con, participants will be advised to not change their daily usual activities and to not participate in any structured physical exercise program during this period.

Eligibility Criteria:
Inclusion Criteria:

* Office blood pressure between 130-179 and 80-110 mmHg for systolic and diastolic blood pressure, respectively;
* Non-engaged in structured exercise programs in the last 3 months before the beginning of this study;
* Able to perform the proposed exercises.

Exclusion Criteria:

* Underlying cardiovascular disease in the last 24 months such as acute myocardial infarction, angina, stroke or heart failure;
* Diseases that reduce life expectancy;
* Smokers;
* BMI \>39.9 kg/m²;
* Diabetic proliferative retinopathy.
Prospective Study of Topical Vitamin C (THDA) Versus Topical Vitamin C (THDA) With Acetyl Zingerone

The purpose of this study is to asses the impact of topically applying a form of vitamin C known as tetrahexyldecyl Ascorbate (THDA) along with a novel anti-aging ingredient, acetyl zingerone, compared against applying THDA alone.

In this study, we examine the effects of adding acetyl zingerone to vitamin-C derived ester THDA on its effects on the signs of photoaging (redness, uneven skin tone, and the appearance of fine lines) and compare it to the effects of applying THDA alone.

Acetyl zingerone is derived from ginger and has anti-oxidant properties

In this study, participants will be randomized to either receiving a THDA + acetyl zingerone product or a THDA only product.

This means that you will have an equal chance of receiving either product. You and the research team will not know which product you have been randomized to received because the products will be labelled with a code. The research team will only know which product contained THDA + acetyl zingerone and which product contained only THDA at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 30 years old and 65 years old.

Exclusion Criteria:

* Individuals who are pregnant or breastfeeding.
* Prisoners.
* Adults unable to consent.
* Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
* Subjects using any topical retinoid, acetyl zingerone, vitamin C, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment.
* Subjects with any of the following facial cosmetic treatments in the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin.
* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
Postoperative Troponin in Renal Dysfunction After Cardiac Surgery

Elevated level of troponin is frequently observed among patients with renal dysfunction. Increase in troponin after cardiac surgery may predict postoperative outcome in cardiac surgery patients. However, the relationship between the increased troponin and outcome after cardiac surgery has not been fully elucidated in patients with renal dysfunction.

This is a retrospective observational study to evaluate the prognostic value of postoperative troponin in patients with renal dysfunction undergoing cardiac surgery. Electrical medical records of patients who underwent cardiac surgery between 2004 and 2015 will be assessed. Perioperative laboratory data including troponin and glomerular filtration rate, type of surgery, and outcome variables including mortality will be analysed to determine the prognostic value of postoperative value of postoperative troponin in patients with renal dysfunction undergoing cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with renal dysfunction who underwent cardiac surgery between 2004 and 2015 at Seoul National University Hospital

Exclusion Criteria:

* Patients without laboratory information on glomerular filtration rate or troponin levels
Efficacy and Safety of SQV in Patients Who Have Chronic IDV Nephrotoxicity

Efficacy and safety of a saquinavir (SQV) based regimen in HIV-1 infected Thai patients who have chronic indinavir (IDV) associated nephrotoxicity.

Primary objective:

To determine whether a switch to a SQV can cause improvements in renal function in patients with chronic IDV associated nephrotoxicity without improvement after IDV dose reduction.

Secondary objective:

1. To describe the pathophysiology of chronic IDV associated renal impairment through renal biopsies at baseline and week 48
2. To describe the pathophysiology of chronic IDV associated renal impairment through renal tubular function at baseline and week 48
3. To determine whether a switch to an SQV can cause improvements in renal pathophysiology in patients with chronic IDV associated nephrotoxicity through renal biopsies performed at baseline and at weeks 48
4. To determine whether a switch to an SQV results in improvements in hypertension, lipid profiles and cutaneous side effects

Eligibility Criteria:
Inclusion Criteria:

* IDV containing regimen for more than 1 year and have creatinine more than 1.4 at least 6 months/abnormal renal imaging/abnormal urinary examinations
* Viral load less than 50 copies

Exclusion Criteria:

* Saquinavir intolerance
Effects of GLP-1 Agonists on Gastric Volume

This study will enroll patients ages 18 and over who have a diagnosis of diabetes, are undergoing an elective surgery under general anesthesia and 1) are taking a GLP-1 receptor agonist medication, or 2) not taking a GLP-1 receptor agonist medication. The patients will have a gastric ultrasound prior to surgery to measure any retained gastric contents. The primary goal is to assess the effect of subcutaneous injectable GLP-1 agonists on preoperative gastric volume in fasted, diabetic surgical patients.


Eligibility Criteria:
Inclusion Criteria

* Age greater than or equal to 18 years old
* Diagnosed with diabetes (listed on medical record, Hgb A1C greater than or equal to 6.5%, fasting blood glucose greater than or equal to 126mg/dL, and/or on medical treatment for diabetes)
* One of the following groups:
* Taking a GLP-1 Medication
* Not taking a GLP-1 Medication
* ASA Physical Classification Status 1-3
* Scheduled for elective surgery under general anesthesia
* Appropriately fasted per ASA Fasting Guidelines 201712

Exclusion Criteria

* BMI greater than 40
* Previous gastric/esophageal surgery
* Abnormal gastric anatomy
* Pregnancy
* Inability or unwillingness of subject to give informed consent
* Non-English Speaking
A Longitudinal Study to Identify IBS Phenotypes Using Fecal Microbiota and Hydrogen Breath Testing

Diarrhea-predominant irritable bowel syndrome (IBS-D) is a highly prevalent but poorly understood condition with limited treatment options. Current therapies, including a nonabsorbable antibiotic rifaximin or diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP), show efficacy in 50% or less of patients. In this proposal, participants with IBS-D will be randomized to receive either rifaximin or low FODMAP dietary intervention.

Diarrhea-predominant irritable bowel syndrome (IBS-D) is a highly prevalent but poorly understood condition with limited treatment options. Recent evidence has established small intestinal bacterial overgrowth (SIBO) and alterations in fecal microbiota as potential etiologies in the pathogenesis of IBS-D. Current therapies, including a nonabsorbable antibiotic rifaximin or diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP), show efficacy in 50% or less of patients \[1-4\]. It has been postulated that limited responses to therapies may stem from failure to identify distinct subgroups in IBS-D stratified by gut microbial profiles. In this proposal, participants with IBS-D will be randomized to receive either rifaximin or low FODMAP dietary intervention. The results of fecal microbiota-derived data as well as hydrogen breath tests will then be longitudinally followed to define SIBO. These methods will be used to test the hypotheses that: (i) distinct IBS-D phenotypes can be generated by defining fecal microbial populations as well as delineating the presence or absence of SIBO; and (ii) longitudinal analyses using microbe-derived metrics and SIBO status may relate to response to treatment with rifaximin or low FODMAP dietary intervention.

Eligibility Criteria:
Inclusion Criteria:

Adult subjects greater than or equal to 18 years of age who meet Rome IV criteria for diarrhea-predominant irritable bowel syndrome (IBS-D).

Prior colonoscopy or sigmoidoscopy within the past 2 years with random colon biopsies to exclude the presence of microscopic colitis.

IBS medications, including anti-depressants, will be allowed if the dose has been stable for at least 1 month before inclusion. Medications will be carefully tracked to follow any potential confounding issues.

Exclusion Criteria:

Underlying celiac disease, inflammatory bowel disease, or other organic disease that could explain their symptoms.

Subjects with a history of GI tract surgery, except for cholecystectomy or appendectomy, will also be excluded from the study.

Women who are pregnant or breastfeeding Antibiotics taken within 3 months prior to enrollment will not be permitted. Subjects on probiotics must discontinue their use at least 1 month prior to enrollment.

Subjects who have previously received formal dietary education for IBS, including a low FODMAP diet, or previously received antibiotics, including rifaximin, for treatment of IBS-D will be excluded from the study.
Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study

The objective of this study is to evaluate 6-to-12-month radiographic outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis that have already undergone treatment with the CATAMARAN SI Joint Fusion System. In addition, retrospective and prospective clinical outcomes will be evaluated.

Patients with degenerative sacroiliitis or sacroiliac joint disruption who already had the CATAMARAN Fixation Device implanted between 6 and 12 months will be asked to return for follow-up visit to evaluate clinical outcomes and undergo a high resolution pelvic CT-Scan to assess fusion. Additionally, retrospective clinical outcomes will be collected from the medical records.

Eligibility Criteria:
Inclusion Criteria:

* Patient \>18 years of age at time of treatment with the CATAMARAN SI Joint Fusion System
* Patient implanted with the CATAMARAN Fixation Device within the last 12 months
* Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis
* Patient, or authorized representative, signs a written Informed Consent form to participate in the study
* Patient is willing and able to complete study follow-up requirements

Exclusion Criteria:

* Known or suspected active drug or alcohol abuse
* Previously diagnosed osteoporosis (defined as prior T-score \<-2.5 or history of osteoporotic fracture) or prior/current use of drug therapy for osteoporosis.
* Prior fracture of any bone related to cancer/tumor (i.e., pathologic fracture)
* Prior diagnosis of tumor in sacrum or ilium
* Unstable fracture of sacrum and or ilium involving the targeted SIJ
* Osteomalacia or other metabolic bone disease
* Use of medications known to have detrimental effects on bone quality and soft-tissue healing
* Patient is pregnant or wishes to become pregnant during the study period
* Patient is not likely to comply with the follow-up evaluation schedule
* Patient is a prisoner or a ward of the state
Recovery Control Tower Feasibility Pilot

A pilot study in perioperative telemedicine that aims to demonstrate the efficiency, and safety of integrating telemedicine into the PACU environment. This pilot study will expand on our previously conducted proof-of-concept study for a telemedicine solution in the PACU. If this pilot study proves to be successful, the study team intends subsequently to expand such a telemedicine solution to multiple clinical locations.


Eligibility Criteria:
* Adults (18 years and older)
* Undergoing elective surgery at Barnes Jewish Hospital in St. Louis, Missouri will be enrolled.
Home-HIT and Type 1 Diabetes

This study aimed to use a multi-disciplinary approach to evaluate a 6-week home-based high-intensity interval training (Home-HIT) intervention in people with type 1 diabetes.

This study aimed to use a multi-disciplinary approach to evaluate a home-based high-intensity interval training (Home-HIT) intervention in people with type 1 diabetes.

Eleven individuals with type 1 diabetes (4 men/7 women; age 30±3 years; BMI 27.1±1.2 kg·m-2; V ̇O2peak 32.4±2.1 ml∙kg∙min-1; duration of type 1 diabetes 10±2 years) completed six weeks of Home-HIT. The effect of Home-HIT on V ̇O2peak, blood pressure, insulin dose and glycaemic profile was assessed pre and post-training. Adherence and ability to meet target heart rate (HR) thresholds (compliance) were monitored using a HR monitor and mobile phone application. Change in glycaemia was measured pre, post and 1h post exercise sessions throughout the six-week period. A qualitative online survey was completed post-training.

This is the first study to combine physiological outcomes with a qualitative evaluation of a training intervention in people with type 1 diabetes. Home-HIT resulted in high adherence alongside increased V ̇O2peak and decreased insulin dose. Because Home-HIT is time-efficient and removes barriers to exercise including fear of hypoglycaemia, it may represent an effective strategy to increase exercise participation in people with type 1 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* duration of type 1 diabetes \>6 months,
* no significant history of hyper- or hypoglycaemia

Exclusion Criteria:

* duration of type 1 diabetes \<6 months,
* significant history of hyper- or hypoglycaemia,
* pregnancy or planning pregnancy,
* uncontrolled hypertension (\>180/100 mmHg),
* angina
* autonomic neuropathy,
* taking any medication that affects heart rate (HR)
* major surgery planned within 6 weeks of the study
* severe nonproliferative
* unstable proliferative retinopathy