cyrilzakka/clinical-trials huggingface dataset:
An Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures

The purpose of this study is to obtain long-term safety and tolerability information on carisbamate as add-on therapy for the treatment of partial onset seizures in patients with epilepsy. Seizure counts will be obtained to measure the rate of seizures for each patient during the study.

CARISEPY3014 is the open-label extension study that follows the double-blind study CARISEPY3013 (NCT00740623). In an open label study such as CARISEPY3014, both the physician and the patient know the name of the assigned study medication. In a double blind study such as CARISEPY-3013, neither the physician nor the patient knows the name of the assigned study medication. Patients who complete the 14-week double-blind treatment phase of study CARISEPY3013 will be eligible to enter the open-label extension study during which patients will transition through a 1-week blinded period to open-label carisbamate. There will be a 1 week blinded transition during which patients will take blinded study medication; after this, patients will then take unblinded, open-label study medication. Safety assessments include the monitoring of the frequency, severity, and timing of adverse events, clinical laboratory test results, 12-lead electrocardiogram (ECG) recordings, vital signs measurements, physical and neurologic examinations, the Physician Withdrawal Checklist for symptoms of withdrawal for those patients who taper and/or discontinue study drug, and pregnancy tests for females of childbearing potential. Seizure counts will be obtained at every visit. The Quality of Life in Epilepsy-31 Patient Inventory questionnaire will be administered once during the study. A Medical Resource utilization questionnaire will be used to obtain cost-effectiveness information on carisbamate and will be administered twice during the study. There is no statistical testing hypothesis for this study. Carisbamate tablets taken twice daily in 2 equally divided doses, with or without food, and taken with noncarbonated water. During the first week on study, patients will take blinded transition study medication and thereafter will take a target dosage of 800 mg/day of unblinded, open-label study medication. The dosage of study medication will range from 400 to 1,200 mg/day. Patients will receive treatment for 1 year with the potential to receive treatment longer.

Eligibility Criteria:
Inclusion Criteria:

* Must have completed the 14-week double-blind treatment phase of study CARISEPY3013
* must be willing/able to follow the restrictions and prohibitions of the protocol
* must be able to complete the patient diaries correctly (patients or legally acceptable representatives)
* must sign an informed consent form indicating agreement to participate in the study (patients or legally acceptable representatives)
* adolescents capable of understanding the nature of the study must provide assent to participate in the study

Exclusion Criteria:

* Patients who have not completed the 14-week double-blind treatment phase of study CARISEPY3013.
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis

A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

Eligibility Criteria:
Inclusion Criteria:

* 18 to 90 years of age inclusive
* Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after
* Has pyuria with \>/= 10 WBCs (white blood cell) and has a positive urine culture within 48 hours of enrollment containing \>/=10 to the fifth CFU (colony forming unit ) /ml of a recognized uropathogen known to be susceptible to IV study therapy (CAZ-AVI and doripenem)
* Demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis.

Exclusion Criteria:

* Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or doripenem
* Patient's urine culture at study entry isolates more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI
* Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
* Patient is immunocompromised
* Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality
Bioavailability of Zinc and Iron From a Whey-based Protein Supplement Consumed With a Habitual Plant-based Diet

Bioavailability of iron and zinc from habitual plant-based diets consumed by young children in Mexico is low due to the high phytate content. Whey protein has been found to increase zinc absorption, thus, providing a whey based supplement with micronutrients may be an effective strategy to increase iron and zinc bioavailability from plant-based foods and alleviate iron and zinc deficiencies. The investigators compared absorption of zinc and iron in children receiving diets with and without whey protein supplements (WPS).

Study 1: Zinc absorption studies The zinc study employed a 2-day cross-over design, labeling the WPS diet with a different zinc stable isotope (67Zn) than the control diet (70Zn). All meals during the 2-day period were labeled with tracer. The dual isotope ratio technique was used with a 3rd Zn stable isotope (68Zn) given intravenously and urine enrichment of all isotopes measured on Study Days 6-9 to measure fractional absorption of Zn (FAZ). The amount of Zn absorbed for the day was determined by multiplying the Zn intake for the day (determined from lab analyses of duplicate test meals) by the FAZ. Children (n=16) were randomized as to the order in which they consume the test and control meals on Study Day 1 and 2.

Study 2: Iron absorption studies The iron study was a cross sectional study with one group receiving control meals and the second group receiving the same control meal plus WPS. Iron absorption was measured using the erythrocyte iron incorporation technique with labeling of all meals over 2 days (58Fe). This was preceded by a reference dose of Fe57 and ascorbate on the previous day. Children (n=32) were randomized to receive the control diet or intervention diet (control diet + WPS).

Eligibility Criteria:
Inclusion Criteria:

* 2-3 years of age
* Live in poor, rural communities
* Healthy
* Parents had provided informed consent

Exclusion Criteria:

* An acute or chronic illness which affects gut function, or
* They are breast feeding.
Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations in Healthy Adults

The purpose of this Phase 1, randomized, open-label, two-period crossover study is to characterize and compare the pharmacokinetic (PK) profiles and evaluate the safety of the AG-348 tablet and capsule formulations after single-dose administration in healthy adult subjects. Pharmacokinetic sampling will take place serially at specified times during conduct of the study.


Eligibility Criteria:
Inclusion Criteria:

* Be a male or female aged 18 to 55 years, inclusive.
* Have a body mass index (BMI) of ≥ 18.5 to ≤ 29.0 kg/m2 at Screening.
* Agrees to abstain from any alcohol consumption.
* Be healthy overall with no clinically significant medical abnormalities, as determined by the Investigator through evaluation of the subject's medical history and Screening vital signs, ECG, physical examination, and laboratory assessments.

Exclusion Criteria:

* Have undergone any major surgical procedure within the 3 months prior to Screening.
* Has at Screening or has had within the 12 months prior to Screening any significant illness.
* Test positive at Screening for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), or human immunodeficiency virus (HIV).
* Have a Screening systolic blood pressure (BP) reading of ≥140 mmHg (≥150 mmHg in subjects \>45 years of age) OR a diastolic BP reading of ≥90 mmHg.
* Has any history of drug or alcohol abuse within the 2 years prior to Screening.
* Is a current smoker or user of any other tobacco product.
* Have had, including by voluntary donation, \> 400 mL of blood collected within the 3 months prior to Screening.
* Have taken within the 14 days prior to study drug dosing any prescription medication, over-the counter medication, or nonprescription preparation-including vitamins, minerals, phytotherapeutic/herbal/plant-derived preparations, or grapefruit juice-unless deemed acceptable by the Investigator OR have taken within the 28 days prior to study drug dosing any restricted product known to strongly induce CYP3A4 metabolism (eg, St. John's Wort).
* Have participated in another clinical research study within the 3 months prior to Screening.
Prevalence of Dyschromatopsia in Glaucoma Patients

Glaucoma is a progressive disease resulting in loss of retinal nerve cells and their axons (retinal nerve fibers). Retinal nerve fibers are ordered in a special manner when they enter the optic nerve. Hence, damage to the retinal nerve fibers by glaucoma results in visual field defects at certain locations. Furthermore, the retinal nerve fiber layers from different receptors for different colors are ordered in a special manner as well. Thus, it is possible that glaucomatous damage causes color vision dysfunction (dyschromatopsia).

At the moment there is disagreement whether dyschromatopsia occurs at early- to mid-stage or only in end-stage glaucoma.

By testing color vision in glaucoma patients the prevalence of dyschromatopsia in glaucoma and in different stages of the disease will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of open angle glaucoma
* visual acuity \>/= 20/50
* age \>/= 18 (no upper limit)
* male or female gender

Exclusion Criteria:

* other type of glaucoma
* age \<18
* other retinal disease (e.g. age related macular degeneration)
* other disease affecting the optic nerve or the retinal nerve fibers
* known color blindness
Dexmedetomidine Verses Propofol for Paediatric MRI Brain

MRI though not painful requires deep sedation for children due to the loud noise created. With deep sedation comes respiratory depression so the interest in Dexmedetomidine. For standardization MRI brain was chosen and also for the fact that patients usually have history of convulsions where drugs like ketamine may not be a good option. Patients were recruited after ethics committee approval. After pre-medication with intranasal midazolam 0.2 mg/kg body weight, Intravenous access was established and then patients were divided in two groups. One group received intravenous propofol 2mg/Kg and infusion of 100mcg/per kg body weight per minute. The other group received intravenous bolus of Dexmedetomidine 1mcg/kg over 10 minutes and then a infusion of Dexmedetomidine 1mcg/kg/hour.

Primary out come was to study the recovery time of patients sedated with Dexmedetomidine compared to patients sedated with propofol for paediatric MRI brain. Secondary outcome were analysed in terms of time for induction,procedural disruptions due to awakening and haemodynamic stability . Follow up was done on phone for any adverse events.

Patients were evaluated on out patient department basis. On the day of MRI nil per oral status of 6 hours was confirmed and consent taken from the parent. In recovery room after recording of vitals, children were given intranasal midazolam 0.2mg/kg body weight. The intravenous line was secured after the child was sedated. Patients were then divided in two groups. In the MRI console, the dexmedetomidine group received intravenous dexmedetomidine 1mcg/kg body weight over 10 minutes. An intravenous infusion of dexmedetomidine was then started at 1mcg/kg/hour.

The propofol group received 2mg /kg of intravenous propofol and an infusion of 100mcg/kg/minute.

MRI monitoring included pulseoximetry, cardioscope, respiratory pattern and rate. Oxygen was delivered by nasal prongs. Primary outcome measured was the time for recovery.

Secondary outcomes were number of awakening during procedure, haemodynamic stability, induction time and any adverse events.

After MRI the children were observed in the recovery room and discharged after achieving 'modified aldred score' of 10. Vitals and any adverse events were recorded during this phase.

Eligibility Criteria:
Inclusion Criteria:

* children posted for elective MRI brain
* American society of anaesthesiologist physical status I and II

Exclusion Criteria:

* age less than 1 year and more than 7 years
* American society of anaesthesiologist physical status III and IV
* emergency cases
* upper respiratory tract infection
* patients on digoxin and beta blockers
* allergy to study drugs
* Body mass index more than 35
Effectiveness of a Dissonance-Based Eating Disorder Prevention Program (The Body Project II)

This study will evaluate the effectiveness of dissonance-based eating disorder prevention programs in reducing body dissatisfaction among young women with body image concerns.

It is estimated that up to 80% of young adult women in the United States are dissatisfied with their appearance, particularly their weight. Young women's perception of the ideal body type is influenced by many factors, including peers, parents, and the media. Body dissatisfaction is associated with an increased risk of depression and eating disorders, making programs to reduce body image issues in young women important. Programs that target eating disorder prevention through promoting healthy behaviors and critiquing the thin ideal may be an effective means of increasing body satisfaction among young women. Particularly, a dissonance-based eating disorder prevention program that assesses the thin ideal through verbal, written, and behavioral exercises may be the best means of addressing body image concerns. This study will evaluate the effectiveness of dissonance-based eating disorder prevention programs in reducing body dissatisfaction among young women with body image concerns.

Participation in this study will last 2 years and will involve both parent and daughter participants. Study participation for parent participants will include three 15-minute interviews conducted at baseline and Years 1 and 2. The interviews will focus on their daughters' social adjustment, performance in school, relationships with others, hobbies, and related topics. Daughter participants will still be allowed to partake in the study even if their parents do not complete all three interviews.

All potential daughter participants will first complete a 20-minute interview regarding their eating habits and mental health. Eligible participants will then be assigned to one of three programs designed to improve body image satisfaction:

* Program 1 will consist of the distribution of an educational brochure about a healthy body image.
* Program 2 will involve four 1-hour meetings during which participants will complete a series of verbal and written exercises. The exercises will aim to increase body image satisfaction by helping participants to think critically about the thin ideal and to discuss some of the problems associated with the pursuit of this ideal.
* Program 3 will include eight 1-hour meetings during which participants will also complete a series of verbal and written exercises. The exercises will aim to increase body image satisfaction by helping participants to think critically about the thin ideal and by promoting healthy eating and exercise habits.

Participants in all programs will complete brief surveys and interviews about their attitudes and behaviors at baseline, at treatment completion, and at three other points during the 2 years from baseline.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported body image concerns

Exclusion Criteria:

* Meets diagnostic and statistical manual (DSM-IV) criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder
Influence of Flat-knitted Compression Stockings Class I and II on Venous Malformations

Diseases with vascular malformations are rare and often congenital, affecting patients of all ages. Depending on their extent and localization, they can cause discomfort and, especially if activity is restricted, lead to loss or reduced quality of life.

The therapy is usually reserved for a few specialized centers and includes interventional sclerotherapy as well as conservative therapy by compression with appropriate compression stockings. However, there are currently no study-based recommendations for this approach.

The aim of this study is to prove a therapeutic effect of compression therapy using flat-knitted compression stockings on venous malformations of the extremities and to derive from this a therapy recommendation in connection with an improvement in the health status and quality of life.

For this purpose, patients with a confirmed venous malformation of the upper or lower extremity independent of previous therapy will be included. We will investigate patients with epi- and/or subfascial localization of the venous malformation independent of the local extent (cross-articular or not).


Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed venous malformation of the upper/lower extremity independent of previous therapy with epi- and/or subfascial localization of the venous malformation independent of the local extent (cross-articular or not)
* Compression stocking can be put on independently or by the parents
* Written declaration of consent present

Exclusion Criteria:

* Lack of compliance, patient is not available for control appointments
* Additional drug therapy (anticoagulation) for extensive venous malformations with threatening thromboembolic complications
* Known allergic reaction/intolerance to components of flat-knitted compression stockings
* Pregnancy
* Rejection of the study participation by the patient
* Contraindications for the planned MRI examination (pacemakers, implants not suitable for MRI, claustrophobia)
* Occurrence of an emergency situation
* Severe heart failure as contraindication for compression therapy
* Peripheral arterial disease as contraindication for compression therapy
Target Heart Rate and Aerobic Interval Training

Aerobic interval training is shown to be superior in increasing oxygen uptake in both healthy and patients with coronary artery disease (CAD), compared to moderate continuous training. However, in cardiac rehabilitation exercise groups, exercise intensity is usually controlled with perceived exertion (Borg scale). The investigators will investigate degree of agreement between target heart rate and perceived exertion during interval training in cardiac rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* referred to cardiac rehabilitation
* able to perform exercise treadmill test

Exclusion Criteria:

* unstable angina
* severe arrhythmias
* heart failure
Choosing the Technique for First Abdominal Entry in Laparoscopy

Several techniques for initial abdominal entry in laparoscopy have been introduced in literature. Various guidelines and recommendations are available on this subject, however, compliance to these are controversial. The purpose of this study is to evaluate the rationale and the process of decision making for first entry technique in laparoscopy.

Several methods, i.e., the Veress needle, open approach using the Hasson trocar and direct trocar insertion without insufflation have been described for initial abdominal entry in laparoscopy. On the other hand, relatively new approaches, e.g., the optical or radially expanding trocars did not become common yet. Despite the advantages of laparoscopic surgery, serious complications can be encountered during the initial entry. Development of a complication, e.g., major vascular and intestinal injury, would affect the outcome of the operation and it may result in conversion to the open approach. Because of low incidence of these complications, it is impossible to show any superiority of one approach to another.

In this study, we aimed to analyze the rationale and the process of decision making of a surgeon about initial abdominal entry technique for laparoscopy.

Eligibility Criteria:
Inclusion Criteria:

* General Surgeons who approve to participate to the study will be included.

Exclusion Criteria:

* Surgical residents will be excluded from the study
Central Venous Catheter-related Complications in Patients Under Anticancer Treatment

Oncology and hemotology patients under anticancer treatments are exposed to increased risks of central venous catheter-related complications due to the underlying cancer and its treament.

This prospective observational monocentric french study aims at describing the incidence of such complications, their morbimortality, and analyzing some risk factors in order to contribute to propose some strategies to reduce these complications' rate and consequences


Eligibility Criteria:
Inclusion Criteria:

All patients older than 18 years, with solid cancer or hematological malignancy receiving anticancer treatment in the outpatient medical department of Alpes Leman Hospital and having a central venous catheter been placed between the 11th of July 2022, and the 1st of January 2023.
Prognostic Value of Each Codon-specific KRAS Mutation in Colorectal Cancer

This retrospective study reviewed 3,144 patients who underwent surgery for colorectal cancer. This study was designed to comprehend the clinicopathological characteristics associated with individual codon-specific KRAS mutations in colorectal cancer.

This study was designed to comprehend the clinicopathological characteristics associated with individual codon-specific KRAS mutations in colorectal cancer including codon 12, 13, and 61. Furthermore, the main objective of this study was to determine whether KRAS codon 13 mutation could serve as a prognostic biomarker of colorectal cancer in a relatively large cohort of subjects. Overall survival (OS) and recurrence-free survival (RFS) were calculated from the date of surgery and compared using the Kaplan-Meier method and log-rank test. For analysis of risk factors for tumor recurrence, Cox proportional hazards regression model was used with the covariance input criterion set as \< 0.1. Patients were subdivided based on primary tumor location (colon versus rectum), and MSI status (MSS/MSI-low versus MSI-high).

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent surgery for colorectal cancer from January 2009 to December 2019.

Exclusion Criteria:

* incomplete data on KRAS mutation
* incomplete data on microsatellite instability (MSI) status
* dual or triple KRAS mutation
* stage IV