cyrilzakka/clinical-trials huggingface dataset:
New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.

Early detection and thus rapid therapy of cardiotoxicity related to chemotherapy are essential for restoring cardiovascular function. The complete recovery of the cardiovascular system decreases with time to identify the presence of cardiotoxic damage. The project aims to define new biomarkers for the early detection of cardiotoxicity in patients treated with chemotherapy.

The most effective approach to minimizing the consequences of cardiotoxicity of oncological treatment is its early identification, adjustment of oncological treatment (change of procedure, dose, drugs), and immediate initiation of cardiovascular therapy. However, the current standard for monitoring the cardiovascular system in cancer patients identifies cardiotoxicity only if functional impairment has already occurred, which precludes any chance of effective prevention. The aim of the project is to identify new biomarkers for the early detection of the cardiotoxic effect of chemotherapy in women with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer
* Chemotherapy with a known cardiotoxic side effect

Exclusion Criteria:

* Known cardiovascular disease
The Effect of Virtual Reality Goggles and Stress Ball Used During Intravenous Catheterization on Pain and Fear in Children

Although distraction methods such as virtual reality glasses, watching videos, watching cartoons, etc. have been reported to reduce pain in the literature, studies on which method is more effective in reducing pain are limited. Considering the developmental period characteristics, virtual reality glasses and stress ball squeezing may be effective in the 6-12 age group during painful intervention. However, no study has been found in the literature on which technique is more effective (9-23). Therefore, investigating the effects of virtual reality goggles and stress ball squeezing on pain and fear in children aged 6-12 years as a distraction method during intravenous catheterization may enable nurses to determine the technique with high clinical usefulness in pain management.

Provide a brief summary of the study, including the purpose, objectives, and brief methodology.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-12 years,
* Between April 20, 2024 and October 20, 2024, children admitted to Mersin Toros State Hospital Pediatrics Departments,
* Children scheduled for intravenous catheterization,
* Those who signed the informed consent form (child and parent),
* Children without mental and developmental retardation,
* They are children who can speak and communicate in Turkish.

Exclusion Criteria:

* Children under 6 years old and over 12 years old,
* Children hospitalized between April 20, 2024 - October 20, 2024 in clinics other than Mersin Toros State Hospital Pediatrics Service,
* Children for whom intravenous catheterization is not planned,
* Those who did not sign the informed consent form (child and parent),
* Children with mental and developmental retardation,
* They are children who cannot speak Turkish and cannot communicate.
CARTO 3 Human Patch Study

The Purpose of this clinical investigation is to observe the changes in relative conductivity between the six ACL patches over time. In addition, the clinical investigation will evaluate the impact of prolonged placement of the ACL patches on subjects' skin on the chest and back. During the study the adhesiveness properties of the patches will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Signed Subject Informed Consent Form
* Healthy subject
* Age Range: 20 - 50 years
* BMI - half o the subjects 18-25 and half \>25
* Chest cage normal anatomy and dimensions
* No history of skin contact patch allergy, of any kind

Exclusion Criteria:

* Chest cage bony deformity
* Known skin allergies to patches, or dermatological conditions requiring therapy
* Presence of any active skin lesion on chest or back
* Any condition that preclude subject from lying down for six hours with minimal movement
* Pregnancy
* Subjects with devices, such as pace makers, IC, loop recorder
Changes in Attentional Control After a Focal Seizure.

Epilepsy is frequently associated with cognitive and attentional disorders. Several studies have pointed out that there are modifications of brain activity in resting state during peri-ictal period in EEG and functional MRI. However, to date, no study has assessed the changes in attentional control after a seizure. The investigators hypothesize that a localized discharge is associated with a disorganization of the networks engaged in attentional control. In this regard, the investigators propose a prospective longitudinal study assessing the changes in attentional control after a focal seizure.


Eligibility Criteria:
Inclusion Criteria:

* Age superior to 18 and under 80
* Focal epilepsy with indication to pre-surgery work-up and 5 days programmed hospitalization dedicated to this work-up
* Normal global cognitive performance (MoCA ≥ 26)
* Be affiliated to the social security system
* Have signed an informed consent

Exclusion Criteria:

* Pregnancy or breastfeeding
* Not able to give consent (Article 1121-8 of the CSP)
* Vulnerable person
* Being deprived of liberty by judicial or administrative decision (Article L 1121-6 of the CSP)
* Guardianship
* Have a high probability of not respecting the protocol or of abandoning the study
* Absence of any epileptic seizure recorded during the hospitalization
* Recurrent seizures preventing the recording of at least 24 hours without any seizure following a seizure.
Visual Acuity After Using A New Monofocal Intraocular Lens Compared To Standard Monofocal Lens

This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. Twenty patients (20) were enrolled in this study 10 patients in each group. It was designed for comparison of uncorrected and best corrected distance and intermediate vision in patients whom implanted with monofocal Tecnis Eyhance or Tecnis 1-piece IOLs.

Purpose To determine the Uncorrected and best-corrected distance, and intermediate visual acuity in a new innovative monofocal intraocular lens compared with standard monofocal lens.

Methods This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. 40 eyes of Twenty patients (20) were enrolled in this study, patients who are candidates for cataract extraction by phacoemulsification were included in this study and underwent thorough preoperative examination and post-operative evaluation at 3 months after the 2nd eye operation, of distance, intermediate, near add, contrast sensitivity and incidence of photic phenomena using a printed questionnaire for evaluating this incidence and binocular defocus curves were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50-75 years old undergoing cataract surgery.
* Preoperative corneal astigmatism equal to or less than - 1.00 D.
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

* Visual potential of less than 0.63 due to ocular pathologies.
* Corneal astigmatism over -1.00 D cylinder.
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions).
* Capsule or zonular abnormalities that would affect postoperative centration or tilt of the lens and pseudoexfoliation syndrome.
* Macular degeneration, cystoid macular edema,Diabetic retinopathy, history of uveitis, optic nerve diseases, glaucoma and amblyopia.
Neural Correlates of Movement Disorders Associated With PRRT2 Related Paroxysmal Kinesigenic Dyskinesia - an Ancillary Study of AMEDYST Research

The main objective of this study is to investigate in real-time the neuronal correlates of paroxysmal dyskinesia episodes related to the PRRT2 mutation within this subgroup of patients (who can control paroxysmal dyskinesia episodes), and more specifically, the pathological role of the reciprocal influence between the striatum and the cerebellum in paroxysmal dyskinesia episodes.

We propose to conduct a study using functional MRI and EEG in this subgroup of patients with the PRRT2 mutation capable of triggering paroxysmal dyskinesia episodes. For both modalities, we aim to perform an analysis of the activation of regions involved in the occurrence of abnormal movements during the prodromal phase when the acquisition is not affected by movements. Using these techniques, we will also investigate the regions involved in judging control over action during phases where abnormal movements may occur before the episode (when the system is excitable) and when it is no longer possible during the refractory period (when the system is no longer excitable). Additionally, we plan to conduct a targeted analysis of functional connectivity in the striato-cerebellar pathway before the episodes (when the system is excitable) and after the episodes during the refractory period (when it is no longer excitable).

Our hypotheses are as follows: 1) there is a relationship between the cerebellum, the basal ganglia and the cortex implicated in the abnormal movements associated with the PRRT2 mutation; 2) the frontal or prefrontal cortex, the cerebellum and basal ganglia are involved in the inhibition of unwanted movements; 3) there is a distortion in the sense of control over action related to paroxysmal dyskinesia episodes.

Eligibility Criteria:
Inclusion Criteria:

Male or female Individuals with dystonic disease carrying a PRRT2 mutation and demonstrating the ability to control paroxysmal dyskinesia episodes.

Affiliated with a health insurance system or a beneficiary of such a system. Individuals aged 18 to 75 years. Signature of informed consent

Exclusion Criteria:

Individuals under guardianship. Individuals not residing in France. Individuals unable to comply with protocol constraints (compliance with visit schedules and ability to perform required tasks).

Individuals undergoing an exclusion period for another research study. Contraindications to MRI
Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS

The aim of this study is to evaluate feasibility of a proprioceptive stimulation under visual feedback treatment protocol (using Gloreha® device) compared to usual physiotherapy treatment in sub-acute stroke patient with Complex regional pain syndrome.

The aim of this study is to evaluate feasibility of a a proprioceptive stimulation under visual feedback treatment protocol (using Gloreha® device) compared to usual physiotherapy treatment in sub-acute stroke patient with Complex regional pain syndrome.

Treatments effect will be evaluated on pain perception, upper extremity functionality and change in pain pressure treshold.

Usual physiotherapy consist of active or passive mobilization, extensor digiti and carpi functional electric stimulation, occupational therapy and taping.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years and \< 85 years
* diagnosis of stroke \< 6 months prior to study enrollment
* diagnosis of Complex regional pain syndrome according to Budapest Criteria

Exclusion Criteria:

* neurological or psychiatric pathology
* severe cardio-pulmonary, renal, hepatic diseases
* pregnancy
Mindfullnes-Based Cognitive Therapy Effect

Objective: In this study, the effect of mindfulness-based cognitive therapy on compliance with immunosuppressive therapy in liver transplant patients was evaluated. Method: It was conducted the study in a randomized controlled type with n=120 participation of liver transplant recipients of a transplant hospital. It was applied mindfulness-based cognitive therapy to liver recipients in the experimental group.

It was used simple random sampling method in assigning liver recipients to the experimental and control groups. Discharged liver transplant patients are informed about the use of immunosuppressive drugs and the drug is prescribed. Liver transplant patients drugs.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria involved (i) being a liver transplant recipient, (ii) currently having immunosuppressive treatment, (iii) being 18 years or older (iv) having no language or communication barrier and (v) agreeing to participate in the study.

Liver transplant recipients

Exclusion Criteria:

* The exact opposite of the inclusion criteria the exclusion criteria.
Effect of Music Therapy Intervention on Pain After Gynecological Surgery

To evaluate the effect of musical therapy before and after gynecological surgeries on pain relief following surgery.

The hypothesis is that musical therapy is effective in pain relief following surgical procedures.

The intention with the study is to focus on the first postoperative phase in a case of pain upon gynecologic abdominal surgery. The literature search revealed studies reporting that participates who had pre-operative session of music intervention for relaxation experienced a greater level of reducing pain levels both pre and post their operation than in the participates in the control group. It is therefore a decision to include one pre operative session of intervention with music therapy in the design.

The study will carry out at the Gynecologic Unit, in Rambam Hospital, Israel.

Eligibility Criteria:
Inclusion Criteria:

* Women are schedule to undergo gynecological surgeries

Exclusion Criteria:

* Neuropathy
* Neurological conditions
* Diabetes
Progesterone for the Treatment of COVID-19 in Hospitalized Men

The purpose of this study is to assess safety and efficacy of progesterone for treatment of COVID-19 in hospitalized men.

Hospitalized men with COVID-19 who meet the eligibility criteria will be informed about study and the potential risks. All the patients giving written informed consent will be randomized in 1:1 ratio to progesterone (100 mg SQ twice daily) plus standard of care or standard of care alone.

Eligibility Criteria:
Inclusion Criteria:

1. Laboratory-confirmed COVID-19 with in 72 hours prior to randomization
2. Respiratory symptoms or abnormal lung exam or abnormal chest imaging AND oxygen saturation ≤94% on room air, or requiring supplemental oxygen less than 50% high flow
3. Understands and agrees to comply with planned study procedures
4. Agrees to the collection of venous blood per protocol
5. Must agree to be placed on prophylactic dose of anticoagulation for prevention of deep venous thrombosis (DVT) while hospitalized

Exclusion Criteria:

1. ALT or AST \>5 times the upper limit of normal
2. History of blood clots
3. History of breast cancer
4. Allergy to progesterone or betacyclodextrin
5. Use of supplemental oxygen prior to hospital admission
6. Requiring higher than 50% supplemental oxygen by high flow nasal cannula or mechanical ventilation
Simplifying First Trimester Medical Abortion Follow-up

This study evaluates the usability of the multilevel pregnancy test among women undergoing medical abortion.


Eligibility Criteria:
Inclusion Criteria:

* Have a first trimester pregnancy with a gestational age of ≤63 days;
* Desire medical abortion with mifepristone and misoprostol and be medically eligible for that treatment, according to clinic protocol;
* Be able to read and understand the local language or Russian;
* Have access to a telephone;
* Agree to follow all study procedures;
* Have no contraindication to participation in the study, in the judgment of the site investigator or designee.
Safety and Efficacy of MK0594 to Treat Overactive Bladder (0594-003)

This study is designed to investigate whether a new drug may offer safe and effective treatment for patients with overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* Patients with predominantly urge incontinence overactive bladder episodes
* Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards

Exclusion Criteria:

* History of Diabetes insipidus, uncontrolled hyperglycemia or hypercalcemia
* Lower urinary tract symptoms associated with benign prostatic hypertrophy
* Active or current Urinary Tract Infections (UTIs)
* Surgery to correct prolapsed uterus or stress incontinence
Description of the Cystatin C as an Early Nephrotoxic Bio-marker in Pediatric Oncology

Cisplatin and ifosfamide are commonly used drugs in chemotherapy. They are known to involve renal toxic threats in children given their immature kidney. This toxicity is increased especially after nephrectomy and/or concomitant radiotherapy. In pediatric oncology, the available evaluation methods of the renal function could be very restrictive to perform on children. In this study, the investigators intend to test the use of the cystatin C as an effective and reliable biological marker of renal toxicity in children treated with cisplatin and / or ifosfamide.

Cisplatin and ifosfamide are commonly used drugs in chemotherapy. They are known to involve renal toxic threats in children given their immature kidney. This toxicity is increased especially after nephrectomy and/or concomitant radiotherapy. In pediatric oncology, the evaluation of the renal function is carried out according to the clinical trial protocols and to the center practices. To date, the standard methods (eg. creatinine clearance), as well as the available predictive formula (eg. Schwartz formula) are not well adapted to monitor children renal function. Indeed, the reliability of these methods depends on several parameters such as the diet and the muscle mass and could be very restrictive to perform on children. To circumvent these practical difficulties, the investigators intend to use the cystatin C as a biological marker of renal toxicity in children treated with cisplatin and / or ifosfamide. This cysteine protease has witnessed an upsurge of interest as an endogenous glomerular filtration rate marker and could be a good candidate to assess tubular toxicity when measured in urine.

This study aims to describe the kinetic of the appearance of the urinary cystatin C and explore its proprieties as an early and cost-effective marker for glomerular and tubular renal toxicity in children. In addition, this method could allow enhancing the calculation models routinely used for glomerular filtration rate.

Eligibility Criteria:
Inclusion Criteria:

* Children of 0 to18 years treated with cisplatin and / or ifosfamide in the hematology-oncology unit of Toulouse University Hospital of children regardless to the pathology they have been treated for
* Children with more than 4kg
* Written informed consent given by both parents or legal representative
* Patient covered by a social security agreement

Exclusion Criteria:

* Impossibility to monitor and follow up the patient until the foreseeable end of the treatment (geographic reasons, etc.)
* Contraindication to EDTA clearance performing
Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy

This study is being done to find out if online referrals to a food management program for Women, Infants, and Children (WIC) made by clinical teams will get more people to enroll in WIC. Women aged 18 or older who get healthcare at Geisinger, are pregnant, and are eligible to be referred to the WIC program will be recruited. These women need to consent to join this study. There are four groups in this study. Group 1 will get usual care with details about WIC from their clinical team. Group 2 will be sent to WIC by their clinical team. The study team may help the clinical team with the referrals. Group 3 will get details about WIC from their clinical team and a dietitian will talk to them about heart-healthy diets and food management. Group 4 will be sent to WIC by their clinical team or study team and a dietitian will talk to them about heart-healthy diets and food management. Participants who talk with the dietitians will be sent kitchen utensils based on need. This study will last about 18 months and will have 240 total subjects joining at about 60 per month. Each subject will be in the study for about 6 months. Subjects will be asked to complete surveys at the start and end of the study. Some subjects will also be asked about their experience in the study after they are done.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Confirmed pregnancy
* Public Insurance (Medicaid) OR no insurance
* If no insurance, must meet income eligibility for WIC
* Intent to deliver at a Geisinger facility
* Able and willing to provide consent

Exclusion Criteria:

* Pre-existing WIC enrollment as a pregnant person
* Not eligible for WIC
* Private insurance
* Unwilling to participate for up to 12 months
Effects of Learning and Food Form on Intake in Humans

Due to the rising incidence of obesity, much emphasis has been placed on identifying mechanisms of increased energy intake. At this point, the mechanisms responsible for the recent increase in obesity prevalence have not been thoroughly examined. Pre-ingestive influences, such as cognitive factors, may play a larger role in creating an energy surplus than previously thought. Expectations about the satiating effect of a food may override the post-ingestive influences in dictating further consumption. In addition, obese individuals may exhibit a decreased compensatory response to foods as compared to lean individuals.

Understanding the effects of energy content, food form, and learning on satiation, satiety, and energy intake will allow for a greater understanding of the mechanisms of energy imbalance as a whole. Food choice is dictated by sensory properties and post-ingestive effects. By utilizing foods with similar sensory properties, the acquired knowledge derived from ingesting these foods can be monitored by analyzing subsequent intake at the same meal and at subsequent eating occurrences. It is hypothesized that the liquid food form will elicit weaker dietary compensation; that is, energy intake at other eating events will not be adjusted to compensate for that food. In addition, it is posited that the lower energy food will cause lower compensation postprandially. By having participants consume the same test food daily over a two week learning period, it is thought that they will show improved dietary compensation when the initial testing is repeated due to learned associations between food properties and metabolism.

No expansion provided.

Eligibility Criteria:
Inclusion Criteria:

* Weight stable (\<3 kg weight change within last 3 months)
* Constant habitual activity patterns (no deviation \> 1x/wk at 30 min/session within last 3 months)
* Constant habitual diet patterns within last 3 months
* Willingness to eat a chocolate-flavored snack at test sessions and two week training period
* No allergies to any test foods
* Not planning to change use of medications known to influence appetite or metabolism
* Not diabetic
* No history of GI pathology
* Non-smoker for one year or more

Exclusion Criteria: