cyrilzakka/clinical-trials huggingface dataset:
Muscle Status to Oral Nutritional Supplementation in Hemodialysis Patients With Protein Energy Wasting

This multi-centred randomized, open label-controlled trial consists of hemodialysis (HD) patients identified with protein energy wasting (PEW) using the International Society of Renal Nutrition and Metabolism criteria. Intervention provided was oral nutritional supplementation (ONS) for 6 months and changes in muscle status in response toward the treatment was measured using ultrasound imaging method pre- and post-intervention.

This study is a multi-centred randomized, open label-controlled trial where a total of 54 HD patients (29 intervention; 27 control) with PEW were recruited from government, private and non-governmental organization settings. Patients were randomized to either the intervention or control group. The intervention group received ONS (475 kcal and 21.7 g of protein), daily for 6 months. Both intervention and control group received standard nutritional counseling during the study period.

Patients who consented were subjected to a screening for identification of PEW and other eligibility criteria. Patients who fulfilled the inclusion criteria were randomized to either control or intervention group. During the 6 months of treatment period, patients in both control and intervention groups were assessed at baseline, 3rd months and 6th months for changes in muscle status using ultrasound imaging and bio-impedance spectroscopy method, malnutrition inflammation complex syndrome using Malnutrition-Inflammation Score, and other measures indicative of nutritional status including anthropometry, biochemistry, dietary intake and quality of life assessment. These parameters were compared at baseline and 6 months for within and between group differences using general linear model test.

Eligibility Criteria:
Inclusion Criteria:

* HD patients receiving standard dialysis treatment (3 sessions per week, 4 hours per session) for \>3 months
* Aged between 18 to 70 years old
* Diagnosed with PEW using the ISRNM criteria

Exclusion Criteria:

* History of poor adherence to HD treatment
* Prolonged hospitalization or surgery in the past 3 months prior to recruitment
* Diagnosed with inflammatory diseases or malignancy
* Vegetarian
* Regular intake of ONS
Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma

To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema in newly diagnosed glioblastoma patients.

Multicentre, randomized (1:1), double blinded trial:- Arm A: Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide ) + Losartan 50mg\*2/day until the halting for any reason - Arm B: Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Histologically confirmed glioblastoma (Grade 4 WHO)
* patients eligible for radiotherapy and concomitant Temozolomide
* KPS ≥ 50%
* Adequate hematologic, liver and renal functions

Exclusion Criteria:

* Patients unable to undergo an MRI with contrast
* Patients without any residual tumor left on the screening MRI of both flair and contrast-enhanced lesions complete surgical resection)
* Any prior treatment of glioblastoma including any local therapy (immunotherapy, Gliadel wafers, .....) during or after surgical resection
* Any on-going treatment for high blood pressure at time of inclusion, whatever the therapeutic class of drugs
* Systolic blood pressure \<110 mmHg.
* relative or definite contra-indication to Losartan:
* Pregnant or breast feeding women; Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective means of contraception
* Non-affiliation to the "sécurité sociale"
Comparing Children's Books to Brochures for Safe Sleep and Infant Reading Education During Prenatal Care

The aim of this randomized trial is to compare a specially designed children's book to brochures for safe sleep education via clinical providers at a third trimester prenatal obstetric visit. Mothers in the control group will receive a specially designed children's book regarding the importance of reading with their infant at this visit, compared to brochures. Knowledge of safe sleep and home literacy orientation will be assessed at baseline prenatally, and their first postpartum obstetric visit.

This study is a randomized controlled trial (RCT) involving 2 groups of pregnant women from low-socioeconomic status (SES) backgrounds at-risk for adverse cognitive and health outcomes for their infant. Mothers will be randomly assigned to intervention and control groups during a third-trimester prenatal visit at a hospital-affiliated obstetric clinic, via convenience sampling. Mothers in the intervention group will receive education on American Academy of Pediatrics (AAP) safe sleep recommendations using a specially-designed children's book (Sleep Baby, Safe and Snug), while those in the control group will receive this guidance via a brochure endorsed by the AAP.

In a "mirror" design, mothers in the control group will receive guidance on reading with their infant using a specially designed children's book (Read Baby, Every Day), and mothers in the intervention group will receive guidance on reading with their infant using a brochure created and endorsed by the AAP.

Clinical research coordinators (CRCs) will obtain consent and collect data at two time points: 1) a 3rd trimester prenatal visit (approximately 36-38 weeks estimated gestational age; baseline), and 2) at the first, regularly scheduled postpartum visit (4-6 weeks after delivery for an uncomplicated vaginal delivery, and 2 weeks for cesarean section). Data will be collected in 4 categories, which will be compared between groups: 1) demographics, 2) maternal knowledge of AAP safe sleep recommendations, 3) maternal attitudes about reading with infants, 4) maternal impression of the printed educational materials provided, and 4) clinician impression of the feasibility and usefulness of the printed materials provided for obstetric prenatal care.

Educational materials will be shared with mothers by obstetric providers (obstetric attending physicians and residents) during this visit, who will be provided with a brief summary of content and to conduct the visit as they see fit. Mothers will be blinded to the aims of the study, other than that it is to "share information about safe sleep and reading with your baby."

Eligibility Criteria:
Inclusion Criteria:

1. confirmed viable pregnancy, with estimated gestational age (EGA) of at least 36 weeks at the baseline/enrollment prenatal visit,
2. maternal age at least 16 years old,
3. comfort speaking English during their visit and reviewing/comprehending study materials without a translator.

Exclusion Criteria:

Non-meeting the above.
Closed Loop Stimulation, Cognitive Performance, and Quality of Life in Pacemaker Patients

The purpose of this study is to compare the influence of accelerometer-based rate adaptation and Closed Loop Stimulation on cognitive performance and quality of life in pacemaker patients.

Within the scope of a usual follow-up schedule the influence of the mode of rate-adaptation on cognitive performance of pacemaker patients will be analysed. Accelerometer sensor will be compared with Closed Loop Stimulation over 2 years. The cognitive performance will be measured by means of a standardized psychometric test. The occurrence of atrial fibrillation and serious adverse events, patient self-assessment and quality of life will be evaluated. An analysis of the telemonitored (Home Monitoring) data will be performed in order to identify predictors of changes or differences in cognitive performance.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a CYLOS pacemaker (implantation within the last 3 to 6 weeks)
* Closed Loop Stimulation mode activated since pre-hospital discharge
* Patients with chronotropic incompetence according to physician's judgment
* Maximum sinus rate \< 100 beats per minute (bpm) OR percentage of atrial pacing ≥ 25%
* Patients suitable for rate-adaptive pacing for at least 2 years
* Patient informed consent

Exclusion Criteria:

* Age under 55
* Pregnant and breast-feeding women
* Patients who are already enrolled in another study
A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)

This is a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides difficile Infection (PRISM4). This Phase 3 trial will be conducted in 2 parts: a randomized, double-blind, placebo-controlled trial arm and an optional open-label treatment arm. After completing standard-of-care (SOC) CDI antibiotics for their most recent CDI recurrence, patients who meet all eligibility requirements will be randomized in a 2:1 ratio to receive either CP101 or placebo. Patients will be evaluated for CDI recurrence and safety follow-up through Week 8, the primary endpoint, as well as through Week 24. Patients who qualify may enroll into the optional open label arm if they experience CDI recurrence through week 8.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Men or women over 18 years of age or older
* Current diagnosis of a recurrence of non-severe, non-complicated CDI
* Subject has a clinical response to standard-of-care CDI antibiotics for the most recent CDI episode
* History of recurrent CDI defined as:

  * ≥ 3 episodes of CDI, with 2 episodes occurring within the previous 6 months (inclusive of the current episode); OR
  * Patients with a history of 2 episodes of CDI occurring within the previous 6 months (inclusive of the current episode) may be eligible if 65 years of age or older.
* For the Qualifying CDI episode, the following criteria must be satisfied:

  * History of diarrhea (\> 3 unformed stools per day) for 2 or more consecutive days that is clinically consistent with CDI. AND
  * Documented positive stool test by local laboratory for toxigenic C. difficile (toxin enzyme immunoassay \[EIA\] or polymerase chain reaction \[PCR\]-based testing) for the current CDI episode and within 45 days prior to Randomization. AND
  * Received a course of SOC CDI antibiotics for the most recent CDI episode (for 10 to 21 days, with exact duration, antibiotic type, and dose at the discretion of the Investigator). AND
  * Demonstrated an adequate clinical response, defined as ≤ 3 unformed stools in 24 hours for 2 or more consecutive days during SOC CDI antibiotics prior to Randomization.

Exclusion Criteria:

* Known stool sample testing positive for enteric pathogen(s) (e.g., Salmonella, Shigella, diarrhoeagenic E. coli, Campylobacter, Giardia) within 28 days prior to Screening
* Pregnant, breast-feeding, or planning to become pregnant during the trial
* Historical or current diagnosis of inflammatory bowel disease
* Recent diagnosis (\<6 months prior to screening) of diarrhea-predominant irritable bowel syndrome (post-infection or non-related to an enteric infection)
* Initiation of any systemic cancer treatment (e.g., chemotherapy, radiotherapy, biologic, immunotherapy, others) for active malignancy
* Major intra-abdominal surgery (e.g., bowel resection)
* Known primary or secondary immunodeficiency
A Study of Subcutaneous Injection in Healthy Participants

The goal of this exploratory study is to learn about the effects of subcutaneous injections on healthy participants.

The study aims to explore how different delivery methods containing a solution impacts injection pain, without an active drug to complicate the results.

Pain assessments will be performed visually and at the injection site to determine the level of pain experienced after each injection.

This study will last approximately 40 days, including screening, assessment, and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Are healthy as determined by medical evaluation including medical history and physical examination
* Have a waist circumference, measured around umbilicus, of at least 78 centimeters (cm) for participants assigned male at birth, and at least 71 cm for participants assigned female at birth
* Have a BMI within the range of 21.0 to 30.0 kilograms per square meter (kg/m²)
* Participants assigned female at birth must be of non-childbearing potential and must test negative for pregnancy prior to injection on Day 1

Exclusion Criteria:

* Have known allergies to hyaluronic acid, related compounds, or any components of the formulation, or history of significant atopy. Components of the formulation include, but are not limited to, sodium hyaluronate, sodium chloride, and sodium phosphate
* Have a history of severe injection-site reactions
* Have current or previous history of anaphylaxis
* Have tattoos or scars over the abdomen, or other factors, for example excessive folds of skin, that, in the investigator's opinion, would interfere with injection site assessments
* Have self-perceived dullness or loss of sensation on either side of the body and the abdomen
* Have a history or presence of a bleeding, wound healing (including diabetes), or fibrotic disorder
* Have known or ongoing psychiatric disorders
Transesophageal Echocardiography(TEE) Probe Insertion and Tracheal Cuff Pressure

Tracheal cuff overinflation is known to reduce tracheal mucosal blood flow and to increase tracheal morbidity. Transesophageal echocardiography (TEE) probe insertion may increase the tracheal cuff pressure. The aim of this study is to evaluate the effect of TEE probe insertion on tracheal cuff pressure and to compare the effects in single-lumen tube and double-lumen tube.


Eligibility Criteria:
Inclusion Criteria:

* adult patients scheduled for elective cardiothoracic surgery
* requiring intraoperative TEE monitoring

Exclusion Criteria:

* patients with tracheal stenosis
* patients with tracheoesophageal fistula
* patients with esophageal surgery
* patients with esophageal varix
* patients with Barrett esophagus
* patients with esophageal hernia
* patients with descending thoracic aorta aneurysm
* patients with dysphagia
* patients with vocal fold palsy
The Effect of Chronic Anemia on Safety Period of Tracheal Intubation in Gynecology Patients

1. Every individual receiving a general anesthetic is at potential risk for developing a ''cannot intubate-cannot ventilate'' situation following anesthetic induction.
2. Building up of oxygen reserves assumes great significance as this provides a longer duration of non-hypoxic apnea should one be faced with an unanticipated difficult airway.
3. The main physiological functions of red blood cell hemoglobin are to deliver oxygen to the peripheral tissues.
4. During anemia, a reduction in blood oxygen content occurs as a result of reduced Hb while arterial oxygenation and oxyhemoglobin saturation remain high.
5. Previous studies about the duration of non-hypoxic apnoea focus on methods to improve the safety period of tracheal intubation.
6. To our knowledge, there is no literature about the duration of non-hypoxic apnoea of anemia patients.
7. The aim of this study was to assess the effect of chronic anemia on the duration of non-hypoxic apnoea during induction of anaesthesia.

After breathing for 3 minutes, anesthesia induction was conducted. The endotracheal tube position was confirmed after anesthesia induction. Patients were left apneic with the endotracheal tube open to room air. The non-hypoxic apneic period was recorded as the time (in seconds) taken for the drop in pulse saturation to 90% or an apneic period of 10 min elapsed, whichever was earlier.

Eligibility Criteria:
Inclusion Criteria:

1. patients scheduled to undergo general anesthesia
2. American Society of Anesthesiologists Performance Status 1-2
3. adults

Exclusion Criteria:

1. Individuals with significant cardiorespiratory or cerebrovascular disease,
2. difficult intubation
3. history of epilepsy
4. body mass index \>25 kg/m2,
5. and those who had smoking history in past 6 months
Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke

The purpose of this study is to determine the efficacy and safety of levofloxacin in treating acute ischemic stroke.

Acute ischemic stroke is a leading cause of disability and mortality. The investigators' previous studies suggested levofloxacin to be a newly identified neuro-protective agent, which could reduce infarct volume and improve neurologic function in animal models. To evaluate the efficacy and safety of levofloxacin in treating acute ischemic stroke patients, the prospective, multicenter and randomized controlled trial was designed.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years.
2. The patients were clinically diagnosed with acute ischemic stroke with NIHSS score ≥5 points and ≤15 points,and NHISS score 1a level of consciousness \< 1 point.
3. mRS≤1 before stroke onset.
4. Signed and dated informed consent is obtained.

Exclusion Criteria:

1. Patients with transient ischemic attack and those undergoing emergency reperfusion therapy, including intravenous thrombolysis and emergency thrombectomy.
2. Patients using glucocorticoids, antiarrhythmic drugs (class I and class III antiarrhythmic drugs: quinidine, procaine amine, lidocaine, phenytoin sodium, verapamil, etc.), and quinolones within 14 days.
3. Patients with other diseases that may aggravate adverse drug reactions, such as ventricular arrhythmias, prolonged QT interval (male: QTc\>430ms, female: QTc\>450ms), severe cardiac insufficiency (NYHA functional grade ≥ III), myasthenia gravis, peripheral neuropathy, seizures, tendon-related diseases, severe immune system-related diseases, hematological diseases, active hepatitis or cirrhosis, serious respiratory diseases.
4. Abnormal liver and kidney function: glutamic oxaloacetic transaminase or glutamic pyruvic transaminase exceeds 3 times the upper limit of normal; Direct bilirubin or indirect bilirubin more than 3 times the normal upper limit; Blood creatinine exceeds 1.1 times the upper limit of normal; Creatinine clearance rate≤50ml/min; Urea nitrogen≥ 20mg/dL.
5. Concurrent infection.
6. Blood glucose lower than 3.9 mmol/L.
7. Patients allergy to fluoroquinolones or other antibiotics.
8. Patients with a life expectancy less than 3 months or patients unable to complete the study for other reasons.
9. Not willing to be followed up or poor treatment compliance.
10. Patients who are participating in other clinical studies, or have participated in other clinical studies within 3 months before enrollment, or have participated in this study.
11. Other conditions not suitable for enrollment.
Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)

The main purposes of this study are to describe the pharmacodynamic effects, safety and pharmacokinetics of a single dose of sarilumab.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with RA as defined by the 2010 revised American College of Rheumatology (ACR)
2. ACR Class I-III functional status, based on the 1991 revised criteria
3. Treated for a minimum of 12 weeks with Methotrexate with a stable dose of MTX for at least 8 weeks prior to screening visit

Exclusion Criteria:

1. Patients less than 18 years of age or minimum legal age
2. Prior treatment with any biologic anti-Interleukin 6 (IL-6) or IL-6 Receptor (IL-6R) antagonists
3. Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening
4. Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks prior to randomization
5. Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening visit, whichever is longer
6. Treatment with oral/ biologic DMARDs (disease-modifying antirheumatic drugs), other than MTX, within a certain amount of time prior to screening visit
7. Active or suspected TB or at high risk of contracting TB
8. Fever, or chronic, persistent, or recurring infections requiring active treatment
9. HIV positive

Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.
A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007

This study will provide long-term follow-up for patients who have received treatment with WU-CART-007 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of WU-CART-007 for evaluation of delayed adverse events, presence of persisting WU-CART-007 vector sequences, and overall survival and progression-free survival.

This long-term follow-up (LTFU) study is designed to follow patients for up to 15 years after WU-CART-007 infusion to evaluate the persistence of the WU-CART-007 cell clones and to explore any unanticipated genetic consequences secondary to the introduction of genetically modified cells. Long-term toxicity, subsequent anti-cancer therapy, and survival status will be monitored.

Patients will transition to this LTFU study when they meet the criteria for discontinuation from the main study or after completing 24 months of follow-up in the main study. Patients will be contacted every 6 months for the first 5 years following WU-CART-007 administration and then yearly, for up to 10 years, for a total of 15 years of follow-up after prior WU-CART-007 treatment or until death, whichever occurs first.

Patients will be evaluated either at the treating site or by the patient's primary Health Care Provider (HCP). Patients will be required to allow key sponsor contacts to continue to access medical records so that information related to their health condition and initial treatment response may be obtained.

Eligibility Criteria:
Inclusion Criteria: Patients that received WU-CART-007 in the context of any investigational study will be eligible to participate in this long-term follow-up study.

Exclusion Criteria: Not Applicable
Triple Target Treatment (3T) Which Combines Stimulation With Amplitude Modulated Middle Frequency (AM-MF), Electromyography (EMG)-Triggered Stimulation and EMG-Biofeedback Compared With EMG-Biofeedback in Anal Incontinence

The efficacy of biofeedback and/or low frequency electrical stimulation for the treatment of anal incontinence has not been proven. First, large well-designed clinical trials are missing. Second, only few patients reach therapeutically relevant intensities with low frequency stimulation. In this study, a novel therapeutic concept, termed triple target treatment (3T) was evaluated. 3T combines stimulation with amplitude modulated middle frequency (AM-MF), electromyography (EMG)-triggered stimulation and EMG-biofeedback. 3T was compared with EMG-biofeedback alone after a nine month treatment period.

Methods In this parallel-group randomised multicenter study with blinded observer we enrolled 158 patients with anal incontinence. Primary endpoints were changes from baseline to nine months in the Cleveland Clinic Score (CCS) and the St. Mark's score (Vaizey score).


Eligibility Criteria:
Inclusion Criteria:

* All Patients with fecal incontinence I-III.

Exclusion Criteria:

* All Patients with CID´s
* Definite or possible pregnancy