cyrilzakka/clinical-trials huggingface dataset:
Cardiac Metabolic Profiling in the Fed State

This is a non-randomized interventional prospective study, aiming to provide insight into cardiac substrate utilization in the fed state. Patients will participate during an elective PVI procedure which would have taken place regardless of the current study. During this study, study subjects will receive peripheral parenteral nutrition (PPN) through an intravenous (iv) line. During the procedure, blood samples will be drawn from the catheters which will be in situ for the purpose of the elective PVI procedure. Cardiac arteriovenous (A-V) gradients of metabolites will be measured, reflecting cardiac uptake and release of metabolites in the fed state.

The heart requires tremendous amounts of energy to sustain its continuous mechanical work. The heart can utilize various metabolic substrates to generate energy, including carbohydrates, lipids, amino acids and ketone bodies. However, most research on cardiac fuel use has been done in rodents and surprisingly little is known about cardiac fuel use in patients with heart disease. Prior experimental studies showed that carbohydrates are important fuels for cardiac energy production. In contrast, a recent study in patients with heart disease showed that the heart only utilizes little amounts of carbohydrates. This study was however, performed in fasting subjects, which could have an important effect on substrate preference. The primary aim of this non-randomized interventional prospective study is to provide insight into cardiac substrate utilization in the fed state. Patients will participate during an elective PVI procedure which would have taken place regardless of the current study. During this study they will receive peripheral parenteral nutrition (PPN) through an intravenous (iv) line. Blood samples will be drawn with the catheters which will already be in situ for the purpose of the elective PVI procedure. Cardiac arteriovenous (A-V) gradients of metabolites will be measured, reflecting cardiac uptake and release of metabolites in the fed state.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective PVI procedure
* Adult age (≥ 18 years)
* Have given verbal and written informed consent

Exclusion Criteria:

* Chronic renal disease with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2
* Chronic liver disease and/or severe liver dysfunction with ASAT and/or ALAT \> 3x the upper limit of normal (ULN)
* Pregnancy or breastfeeding
* Insulin dependent diabetics
* Congenital metabolic disease
* Weight below 40 kg
* Inability to understand and read Dutch or English
* Known allergy or hypersensitivity to any of the non-investigational products in the study protocol
* Any other clinical condition that would jeopardize patient's safety while participating in this trial or may prevent the patient from adhering to the trial protocol.
Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes

Continuous glucose monitors, as a technology that aims to improve glycaemic control in patients with type 1 diabetes, must always adjust to changes in blood glucose levels in these patients, e.g. during sporting activities. In women, in particular, menstruation and its different phases can affect blood glucose levels in different ways. Therefore, this study aims to determine whether there is a different behaviour of blood glucose levels during aerobic or high-intensity exercise in different phases of menstruation. If so, we will try to model this behaviour and create specific guidelines in this regard in terms of physical exercise programming in women. In addition, the information derived from this study will be used to design better artificial pancreas systems that take into account the effects of the menstrual cycle in women.


Eligibility Criteria:
Inclusion Criteria:

Age between 18-45 years T1D with a diabetes duration for more than 2 years Glycated hemoglobin (HbA1c) \< 8.5% (\<69 mmol mol-1) Stable insulin regimen in the past 6 months with less than 20% change in total insulin daily dose Multiple daily injections or insulin pump Weekly physical activity of 90 min or more, but no practicing any sport as amateur or professional.

Exclusion Criteria:

Clinical conditions or use of medications (other than insulin) known to affect glycemic control (e.g., oral/parenteral steroids or metformin, among others).
MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery

Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence of chronic pain 3 months after breast cancer surgery.

Before anesthesia, the second or third intercostal space is located. After an aspiration, 0.35 mL/kg of solution (ropivacaine 7.5 mg/mL or saline, maximum 30 mL) are injected into the paravertebral space. After 30 minutes, spread of PVB is evaluated by cold test on skin. Then, general anesthesia is induced.

Evaluation of the frequency of chronic pain at 3, 6 and 12 months by the Brief Pain Inventory (BPI) questionnaire and Neuropathic Pain Diagnostic (DN4) and Anxiety and depression evaluation by the Hospital Anxiety and Depression questionnaire (HAD) will be done.

Eligibility Criteria:
Inclusion Criteria:

1. Women with non-metastatic invasive breast carcinoma or breast carcinoma in situ treated by:

   * either breast-conserving surgery with axillary lymph node dissection
   * either radical surgery with or without axillary lymph node dissection.
2. 18 years ≤ Age ≥ 85 years.
3. ASA class 1, 2 or 3.
4. No analgesic treatment for 2 days (no pre-existing chronic pain)
5. If a biological control has been requested recently or deemed necessary by the Investigator, then it should be satisfactory : Adequate hematologic and hemostasis: neutrophil count (ANC) \> 1500/mm3, haemoglobin \> 9 g/dl and platelets \> 75 000/mm3, prothrombin time \> 70%, activated partial thromboplastin time \< 1.5 X Upper Limit of Normal (ULN)
6. Life expectancy ≥ 2 years.
7. Signed informed consent form.
8. Patient able to meet the self-assessments questionnaires (sufficient understanding assessments, proficiency in French)
9. Patient affiliated with a health insurance scheme (beneficiary or legal)

There is no prohibition for people to take part simultaneously in another search and there is no exclusion cause at the end of the research period.

Exclusion Criteria:

1. Ongoing neoplasm or history of malignancy other than breast cancer with the exception of: basal cell carcinoma, cervical carcinoma in situ, other treated cancer that has not relapsed during the 5 years preceding inclusion in the trial.
2. Bilateral breast carcinoma at the inclusion
3. Male subjects.
4. Metastatic breast carcinoma at diagnosis (M1).
5. Severe heart, liver and respiratory failure (ASA 4)
6. Allergy to local anesthetics and morphine.
7. Use of analgesics during the 48 hours preceding the surgical procedure.
8. History of breast surgery with painful sequelae
9. Major deformation of the spine
10. Puncture site infection
11. History of substance abuse.
12. Pregnant or lactating women, or women of childbearing potential without effective contraception
13. Subjects deprived of their liberty or under guardianship (including temporary guardianship).
14. Subjects unable to comply with medical follow-up of the trial for geographical, social or psychological reasons.
Creation of a Biobank of Fertile Men

Collection and conservation of human biological material from fertile subjects, i.e. men with previous parenthood (normospermic men, natural fathers).

The project aims to collect biological material derived both from surgical resections of the most common urological tumors and from peripheral blood or other biological fluids such as urine or seminal fluid when available. The objective of the study is to establish a biobank of human biological material, which will allow access to samples of extreme value for the pathophysiological study of the tumor, its origin, mechanisms and markers of progression, as well as the creation of this collection it will represent an extremely valuable tool for the study of individual response to therapies.

Eligibility Criteria:
Inclusion Criteria:

* Normospermic male individuals
* Naturally fertile male individuals
* Male individuals \> 18 years

Exclusion Criteria:

* Non-normospermic male individuals
* Male individuals who are not naturally fertile
* Male individuals \< 18 years
A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients.

This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter, two parallel-group study in male patients with the AMN phenotype of X-linked adrenoleukodystrophy (X-ALD) to assess the efficacy and safety of MIN-102 treatment. Study sites will consist of specialist referral centers experienced in the management of adrenoleukodystrophy (ALD).


Eligibility Criteria:
Inclusion Criteria:

* Male and between 18-65 years of age.
* Diagnosed with X-linked adrenoleukodystrophy (X-ALD) based on elevated VLCFA and genetic testing.
* Clinical evidence of spinal cord involvement.

Exclusion Criteria:

* Any other chronic neurological disease with signs of spastic paraplegia, such as hereditary spastic paraplegia, multiple sclerosis, etc.
* Presence of inflammatory (Gd-enhancing) MRI lesions or any abnormality other than those mentioned in the inclusion criteria.
* Known type 1 or type 2 diabetes.
* Known intolerance to pioglitazone or any other thiazolidinedione.
* Taking or have taken honokiol, pioglitazone or other thiazolidinediones within the 6 months prior to screening.
* Previous bone marrow transplantation.
* Previous or current history of cancer (other than treated basal cell carcinoma).
* Previous or current history of congestive heart failure.
nSTRIDE APS in Females With Primary Patellofemoral Osteoarthritis

The purpose of this study is to evaluate clinical outcomes following a single injection of nSTRIDE Autologous Protein Solution in females with isolated patellofemoral osteoarthritis. A secondary objective of this study is to document the duration of treatment effect following nSTRIDE injection.

Clinical trials have, in general, formally demonstrated the effectiveness and safety of various autologous therapies for the treatment of knee OA. Differences in the processing of autologous therapies can yield substantial differences in the resulting output. Thus, making generalizations regarding the effectiveness across these autologous therapies is more complicated. Each autologous therapy requires independent efficacy evaluation. nSTRIDE APS has been shown to decrease pain, increase function and have a favorable safety profile in a pilot trial. Further, demonstration of the treatment effects in patellofemoral osteoarthritis, an important subset of knee osteoarthritis is lacking. This study will evaluate a population of female patients with patellofemoral osteoarthritis in which treatment with other modalities provides limited/short lived relief with the hope that APS treatment will provide and extend relief to these patients. The study will document the treatment effects and timeline of treatment effects for nSTRIDE APS following a single injection (per symptomatic knee).

Eligibility Criteria:
Inclusion Criteria:

* Patient must be female
* Isolated patellofemoral osteoarthritis (PFOA) in one or both knees as diagnosed by the treating physician
* Objective evidence of PFOA on one or both of a radiograph or MRI taken within 3 months of treatment
* From 40-65 years of age, inclusive at time of injection
* Symptoms return such that there is a need for further treatment within 3 months of a corticosteroid or hyaluronic acid injection
* Willing and able to comply with the study procedures
* Sign informed consent form

Exclusion Criteria:

* Any systematic inflammatory condition (e.g. rheumatoid arthritis)
* Active malignancy at time of injection
* Pregnant at time of injection
* Lactating at time of injection
* Knee joint infections or skin diseases or infections in the area of the injection site
* Leukemia, metastatic malignant cells, or who are receiving chemotherapeutic treatment
* Participation in another device, biologic or drug study
Retrospective Study of Carebot AI CXR Performance in Preclinical Practice

The purpose of this study is to describe the design, methodology and evaluation of the preclinical test of Carebot AI CXR software, and to provide evidence that the investigated medical device meets user requirements in accordance with its intended use. Carebot AI CXR is defined as a recommendation system (classification "prediction") based on computer-aided detection. The software can be used in a preclinical deployment at a selected site before interpretation (prioritization, display of all results and heatmaps) or after interpretation (verification of findings) of CXR images, and in accordance with the manufacturer's recommendations. Given this, a retrospective study is performed to test the clinical effectiveness on existing CXRs.

The performance of the trained and internally validated Carebot AI CXR software is tested on a set of 127 CXR images from target population. This is compared to common clinical practice, i.e., image assessment by a radiologist in a hospital. Patients may have a variety of findings; at this stage of the evaluation, an abnormal finding is considered to be an abnormality in any of the defined classes. False negative images incorrectly predicted by Carebot AI CXR software result in a clinical impact determination.

To collect the CXR data for retrospective study, investigators addressed a municipal hospital in the Czech Republic that provides healthcare services to up to 130,000 residents of a medium-sized city (approximately 70,000 inhabitants) and the surrounding area. 127 anonymized CXR images were collected between August 15 and 17, 2022, and subsequently submitted to five independent radiologists of varying experience for annotation. The selected radiologists were asked to assess whether the CXR image shows any of the 12 pre-selected abnormalities. Pediatric CXR images (under 18 years of age), scans with technical problems (poor image quality, rotation), and images in lateral projection were excluded from the dataset.

Eligibility Criteria:
Inclusion Criteria:

* Hospital patients who were referred for chest radiography between August 15 and 17, 2022.

Exclusion Criteria:

* Pediatric CXR images (under 18 years of age)
* Scans with technical problems (poor image quality, rotation)
* Images in lateral projection
Microbial Surveillance in Children Hospitalized for Cardiovascular Surgery

the purpose of this study is to determine whether children who are hospitalised waiting for cardiac surgery for several days in pediatric or pediatric surgery department acquire resistant microbial flora, thus necessitating broad spectrum antibiotics for perioperative prophylaxis.

Background

Guidelines for antimicrobial prophylaxis for cardiac surgery advise using first generation cephalosporin for those children coming from home. Large number of children that pass cardiac surgery in Hadassah University Hospital, Jerusalem, are hospitalized for several days before the operation in Pediatric Surgery department due to administrative reasons. These children receive broad spectrum antibiotics, vancomycin and ceftazidime, as a peri-operative prophylaxis, in order to prevent infection with hospital acquired flora with which they could become colonized with during this period. This policy causes exposure to broad spectrum antibiotics from the beginning in these children, and also providing an antimicrobial pressure in the intensive care unit, influencing the development of resistant flora.

There is no documentation that these children acquire resistant flora during there hospitalization in the pre-operative period. We suggest checking microbial flora in those children hospitalized for cardiac surgery, in order to determine the need for broad spectrum antimicrobial prophylaxis.

Goals

To check microbial flora in children hospitalized for cardiac surgery on different time points: on admission and during hospitalization in Pediatric Surgery Department, on admission to PICU (immediately after operation),after 3 - 5 days,when drains are extracted.

To document if there is a change in resistance pattern of microbial pathogens during these periods

To determine the optimal regimen for antimicrobial prophylaxis for those children who need to be hospitalized in this department before the operation

Methods

Surveillance cultures would be taken from children who are hospitalized for cardiac surgery on several time points:

1. on admission to Pediatric Surgery or other department pre-operatively
2. once weekly afterwards, if they continue to be hospitalized without surgery
3. on admission to PICU after surgery
4. during their subsequent hospitalization in PICU after 3 - 5 days
5. on the day of drains extraction

These cultures will include the cultures of nostrils, throat,axillas, perineum and rectum and post operative wound.

Eligibility Criteria:
Inclusion Criteria:

* All children and infants who are hospitalized in general pediatrics or pediatric surgery department before they undergo cardiac surgery
Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)

To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether extended lymphadenectomy (CME) could improve disease-free survival in patients with right colon cancer, compared with D3 radical operation in laparoscopic colectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients suitable for curative surgery 18-75years old
2. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
3. Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon;
4. Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T stage 1-4 and N stage 0-2; there is no distant metastasis.
5. Informed consent

Exclusion Criteria:

1. Simultaneous or simultaneous multiple primary colorectal cancer;
2. Preoperative imaging examination results show: (1) Tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform R0 resection;
3. History of any other malignant tumor in recent 5 years;
4. Patients need emergency operation;
5. Not suitable for laparoscopic surgery;
6. Women during Pregnancy or breast feeding period;
7. Informed consent refusal
Effects of Light and Exercise on Human Circadian Rhythms and Performance

Both light and exercise are effective countermeasures for space and ground-based crews for circadian phase resetting and alertness levels. The investigators propose to test the combined effects of these two countermeasures to determine whether adding exercise to light stimuli will further improve circadian phase resetting and alertness.


Eligibility Criteria:
Inclusion Criteria:

* healthy by history, physical exam, laboratory studies of blood and urine, and psychological screening
* moderate-intensity exercise for at least 150 minutes per week

Exclusion Criteria:

* color blind
* no prescription medications, except hormonal birth control in females
Prophylactic Antibiotic Treatment in Hemodialysis

The purpose of this study is to assess the efficacy of prophylactic antibiotic treatment on blood stream infections and severe culture negative infections, in patients on newly started hemodialysis(HD), with a central venous catheter as vascular access.

After being informed about the study and potential risks all eligible patients, giving written informed consent will be included in the study. At week 0 patients will be randomized in a single blinded manner (participants and care providers) in a 1:1 manner to receive 500/125mg amoxicillin/clavulanic acid 30-120 minutes before each hemodialysis with a central venous catheter (CVC) as vascular access, or corresponding placebo. The timing of antibiotic administration has been established in a pilot-study in order to secure a sufficient concentration of antibiotics during the dialysis session. In case of side effects to amoxicillin/clavulanic acid, the prophylactic antibiotic will be shifted to 600mg clindamycin. Total treatment period with prophylactic antibiotics is 6 months, with a 1 year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* End Stage Kidney Disease (ESKD) patients who receive an uncuffed or cuffed CVC for expected chronic HD, regardless of previous ESKD treatment modality (PD or KTX) and hemodialysis access (AV-fistula or AV-graft))
* ≥18 years
* Ability to understand the study background, risk and benefit of treatment and to give written informed consent

Exclusion Criteria:

* Unable to give informed consent
* Known intolerance to beta-lactam antibiotics and clindamycin
* Active infection treated with antibiotics
* Breastfeeding
* Pregnancy. In women of childbearing age, an approved birth control must be ensured at least 1 month before and during all the 6 months of antibiotic/placebo treatment.

Patients may be rescreened later i.e. within a time period of one month from start of HD, if exclusion criteria are reversible.
Impact of a Breath-controlled Video Game App

The proposed research study will assess the impact of a newly developed, breath-controlled app and custom-designed tablet (equipped with a breathing sensor) on the patient and parent's preoperative anxiety and anesthesia induction experience.

Aim 1: Determine whether induction distress differs between patients using the breathing-controlled app and those using standard care interventions: The investigators will measure patient compliance with induction using the Child Induction Behavioral Assessment (CIBA). The investigators predict that patients using the breathing-controlled app will demonstrate significantly better induction compliance. Older children (ages 6-8) are typically more cooperative with induction than younger children (ages 3-5 years). Both age groups will be studied to determine whether there are age-related differences impacting receptiveness to the app.

Aim 2: Compare patient anxiety between the breath-controlled app and control group. The investigators will measure child preoperative anxiety (modified Yale Preoperative Anxiety Scale, the "mYPAS-SF"). The investigators predict there will be significantly lower anxiety (mYPAS-SF) during induction for children in the breath-controlled app group.

Aim 3: Compare parent anxiety between the breath-controlled app and control group. The investigators will measure parental anxiety using the Visual Analog Scale for Anxiety, the "VAS-A". The investigators predict there will be significantly lower anxiety (mYPAS-SF) during induction for parents in the breath-controlled app group.

Aim 4: Determine overall family satisfaction with the induction experience. A survey will be administered to assess satisfaction levels with induction behavioral interventions and determine whether these scores differ between the intervention and standard care group. The investigators predict that satisfaction scores will be higher in the intervention group than the control group.

Eligibility Criteria:
Inclusion Criteria:

* Presenting to Same Day Surgery department at CCHMC Liberty campus
* Outpatient or 23 hour admission
* Any surgery or procedure under anesthesia
* Ages 3 to 8 years
* Male or female
* Any ethnicity
* American Society of Anesthesiologists (ASA) physical classification status I or II
* Patient has never had a prior anesthetic
* Family and participant communicate primarily in English \& signed English anesthesia consent
* Normal neurocognitive development
* Patient is undergoing inhalation induction using an anesthesia mask
* Parent/guardian is present for induction
* Patient does not receive a premedication for anxiety

Exclusion Criteria:

* Neurocognitive delays
* Developmental delays/Behavioral diagnoses, such as (but not limited to) ADHD, Autism, Oppositional defiant disorder, Obsessive Compulsive Disorder, Anxiety disorder
* Patient takes medications routinely for behavioral issues
* Tracheostomy
* Inpatient or planned \>23 hour admission