cyrilzakka/clinical-trials huggingface dataset:
IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION

Magnetic properties of myocardial tissue change in the presence of disease. This is detectable in the change of rate of magnetic relaxation, and measurable by T1 and T2 mapping using cardiovascular magnetic resonance (CMR). These markers provide novel quantifiable imaging measures for myocardial tissue characterisation. Despite similar principles, the measurements differ considerably between different sequences, vendors and field strengths, yielding a necessity to establish robust sequence-specific normal ranges, diagnostic accuracy, relationships with clinical characteristics, cardiovascular risk factors, routine cardiac imaging parameters, and prognosis. A further unknown relates to separation between healthy myocardium and subclinical disease in subgroups of patients with suspected cardiac involvement. Examples include patients with possible inflammation, such as in patients with a recent COVID-19 infection or vaccination. Anticipated recruitment of a total of 3000 subjects, with 1500 subjects per field strength (1.5 and 3.0 Tesla).


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent
2. 18 years of age and over
3. Absence of a valid clinical indication for CMR, and/or known or clinically relevant cardiac disease

Exclusion Criteria:

* accepted contraindications for a contrast-enhanced CMR study (in line with MRI safety and SmPC for contrast agent)
Analyze the Relationship Between the Density of Fat Tissue and Cellulite With the Lumbar Lordosis Degree

The aim of this study is analyze the relationship between the density of visceral and subcutaneous fat and cellulite with the lumbar lordosis degree.

There are two types of abdominal fat: subcutaneous adipose tissue which is more superficial, lying above the abdominal muscle wall and visceral adipose tissue, corresponding to the intra-abdominal fat witch is more harmful to health.

The accumulation of fat tissue differs between genders and age. Men have a huge propensity for developing central fat and women accumulate more subcutaneous fat tissue on the gluteal-femoral region. Some authors suggest that the accumulation of fat tissue increases with age.

Several studies have concluded that there is a relationship between the abdominal fat storage and the degree of lumbar curvature.

In addition, some authors also suggest that there is a relationship between the degree of lumbar lordosis and cellulite, which is related to circulatory changes.

However these relationships are not yet clarified in the literature.

Eligibility Criteria:
Inclusion Criteria: All the community of the School of Allied Health Technologies; aged between 18-60

Exclusion Criteria: Pathologies (cardiovascular, metabolic, cancer, respiratory, muscular); pregnancy; abdominoplasty; collum and gluteal surgeries; deregulated menstrual cycle ; anatomical changes; anticelulitic treatments
Validation of a Molecular Signature for Early Detection of Colorectal Cancer

The goal of this Multicentre and international prospective study is to validate a molecular signature using plasma samples in average-risk population for colorectal cancer who undergo colonoscopy in a screening setting.

The main question it aims to answer is:

Does molecular signature in plasma sample have higher diagnostic accuracy than FIT for early detection of colorectal cancer? Participants who already have a colonoscopy as part of their regular medical care for colorectal cancer screening will provide a stool sample and a plasma sample.


Eligibility Criteria:
Inclusion Criteria:

* Participants between the ages of 50 and 75 (both included) at the time of informed consent signed. They must understand the nature, significance, implications and risks of the clinical trial and must sign the informed consent form.
* Participants referred to the gastroenterology service who are going to undertake colonoscopy as a regular procedure for screening setting.
* Participants asymptomatic, average risk for CRC. Average risk is defined as those individuals who are age 50 or older with no history of adenoma, colorectal cancer, or inflammatory bowel disease, and with no family history of CRC (first degree relatives).

Exclusion Criteria:

* Participants between the ages of 50 and 75 (both included) at the time of Informed consent signature. They must understand the nature, significance, implications and risks of the clinical trial and must sign the informed consent form.
* Participants who have been diagnosed with CRC. The diagnosis must be subsequently confirmed by biopsy or surgery and pathological anatomy analysis during the study.
Food Intake and Gut Hormones in Patients Who Have Undergone Upper Gastrointestinal Surgery for Cancer

Improvements to treatment strategies for patients upper gastrointestinal cancers have produced an increasing population of people who remain free from disease recurrence in the long term. Weight loss and nutritional problems are common among patients who attain long-term remission and cure after surgery for upper gastrointestinal cancers. However, the mechanisms underlying these problems are not well understood. In this study the investigators aim to determine whether reduced food intake after upper gastrointestinal surgery is caused by early satiety related to exaggerated post-prandial gut hormone responses.

This is a randomized, double-blind, placebo controlled, crossover study of the effect of 100μg octreotide SC on ad libitum food intake in patients free from complications or recurrence at least one year post-oesophagectomy, gastrectomy or pancreaticoduodenectomy. A comparator group of age, weight and gender matched subjects will be studied concurrently, and caloric intake and subjective symptom scores after administration of octreotide versus placebo among surgical and comparator subjects will be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Surgical procedure: Two-stage, three-stage or transhiatal oesophagectomy with gastric conduit reconstruction and pyloroplasty, total gastrectomy with Roux-en-Y reconstruction, pancreaticodueodenectomy, or matched unoperated healthy controls
2. At least one year in remission post-resection (surgical groups)

Exclusion Criteria:

1. Pregnancy, breastfeeding
2. Significant and persistent chemoradiotherapy and/or surgical complication
3. Other previous upper gastrointestinal surgery
4. Significant dysphagia or odynophagia, unable to eat
5. Other disease or medications which may affect satiety gut hormone responses
6. Active and significant psychiatric illness including substance misuse
7. Cognitive or communication issues or any factors affecting capacity to consent to participation
8. History of significant food allergy, certain dietary restrictions
9. Confirmed or suspected residual or recurrent disease after surgery, second primary malignancy
10. Other reconstruction (eg colonic or jejunal interposition)
11. Any contraindication to octreotide administration
Intranasal Ketamine Effectiveness in Reducing Intramuscular Injection Pain Before Sedation Among Children

Hypothesis: Intranasal administration of ketamine would reduce the intramuscular pain of ketamine injection in children who undergo procedural sedation and analgesia in the emergency department.

Ketamine is a well-known medication in children's procedural sedation and analgesia. While it provides good analgesia along with sedation, its injection is painful and causes distress in children. Intranasal administration of Ketamine would reduce the intramuscular pain of ketamine injection in children who undergo procedural sedation and analgesia in the emergency department. This will also assess if intranasal administration would affect the depth of sedation and hospital length of stay of this group of patients.

Eligibility Criteria:
Inclusion Criteria:

• Children who need to undergo procedural sedation and analgesia

Exclusion Criteria:

* Weight over 33 Kg
* No Consent from parents/patient
* Needs immediate procedure due to patient's condition
* Growth/mental retardation
* Sensory deficit at the site of intramuscular injection
DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer

Palliative radiotherapy for head and neck cancer is widely used but the effect and side effects are largely unknown. We will study the effect of short hypofractionated palliative radiotherapy (20 Gy in 4 fractions) on symptom intensity and -frequency as weel as side effects


Eligibility Criteria:
Inclusion Criteria:

* Incurable primary or second primary head and neck cancer
* Speaks and reads Danish
* Capable of filling out questionnaires for at leas two months after radiotherapy
* Age\>=18 years
* Expected survival\> 3months
A Multi-National Study In Bladder Cancer Patients to Detect Recurrences After TURB (Trans-urethral Resection of the Bladder) Earlier With the Xpert Bladder Cancer Monitor Assay (ANTICIPATE X)

Bladder cancer is the 5th most common cancer in Europe, with more than 151,000 new cases diagnosed in 2012 (4% of the total). Bladder cancer has the highest recurrence rate of any malignancy, often as high as 70% within 5 years of successful treatment. This high recurrence rate requires diligent and accurate monitoring as a means for early diagnosis and treatment. Considering the burden associated to repeated invasive cystoscopies, there is a need for robust but accurate tests for surveillance. In that prospect, urinary molecular tests have been developed although none were deemed adequate in the European clinical guidelines to replace cystoscopies. The Xpert Bladder Cancer Monitor Assay is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with this cancer. The test provides a fast and accurate result, is non-invasive and easy to perform. The aim of this study is to assess the non-inferiority of the Xpert Bladder Cancer Monitor assay in detecting recurrences in comparison to cystoscopy in the follow-up of patients with low or intermediate risk non-muscle-invasive bladder cancer (NMIBC).

Patient recruitment and follow-up are closed. The study is in analysis phase.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing a follow-up cystoscopy at the time of enrolment for low or intermediate risk NMIBC patients in the follow-up phase (according to the 2017 EAU guidelines),
* Patient must accept to be followed for 1 year after enrolment cystoscopy,
* Patient who can provide urine samples naturally (e.g. no catheterization),
* 18 years or older at the time of enrolment,
* Signed informed consent.

Exclusion Criteria:

* Patient with history of NMIBC stratified at the time of enrolment as high risk according to 2017 EAU Guidelines,
* Patient with history of Muscle-Invasive Bladder Cancer (MIBC),
* Patient having undergone a TURB less than 3 months before enrolment,
* Patient having received Mitomycin C (MMC) or Bacillus Calmette-Guerin (BCG) intravesical instillations less than 3 months before enrolment (a single MMC post-operative instillation is acceptable for inclusion).
Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation

After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).This ECAP is measured intra operatively, after 4 weeks( at switch on), after 3months and 6 months following cochlear implantation.

After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).This ECAP is measured intra operatively, 4 weeks(at switch on) and after 3months and 6 months following cochlear implantation. Neural Response Telemetry (NRT) is a quick and non-invasive way of recording ECAP of the peripheral auditory nerves in-situ. It gives clinicians valuable information for programming the T- (Threshold) and C-(Comfort) - levels of the recipient's speech processor map. Intraoperative NRT in conjunction with electrode impedance data can help indicate the integrity of the implanted electrodes and the electrode/auditory nerve interface, confirming that the implant is functioning correctly intraoperatively.

Eligibility Criteria:
Inclusion Criteria:

* All children between 1 and 6 years of age undergoing cochlear implantation in JIPMER during the study period.

Exclusion Criteria:

* Incomplete electrode array insertion.
Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases

Patients with acute leukemia or received SCT are hospitalized in protected area, at least for 28 days. In this area, there is some rules like: controlled-visit, protective-clothing....so patient are in social and familial isolation condition.

During their hospitalization, patients are confront to aggressive treatment and psychological distress related to potentially death.

Emergency hospitalization, illness, controlled environment, aggressive treatment and potential complications place patients in a context of anxiety-provoking.

Aesthetic therapy is a new supportive care in cancer therapy access on improving well-being, relaxation and body image.

This supportive care is already used in cancerology department, particularly in breast cancer patients.

In our department, a few patient received aesthetic care during their hospitalization and they appreciated these sessions and impact on well-being was immediately.

Moreover only 6 sessions was proposed and effect on anxiety wasn't measurable Aesthetic care improve well-being but impact on anxiety is unknown. In this study we evaluate the impact off socio aesthetic on the quality off life and anxiety. We evaluate this impact by 3 questionnaires at 3 times during hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Patient (male or female) ≥18 years old
* Hospitalized patient in restricted area than 21 days
* Patient with acute leukemia (induction or relapse)
* Patient hospitalized for hematopoietic stem cell transplantation
* Written Inform consent must be obtained before inclusion and randomization
* Patient affiliated to and covered by social security for standard care

Exclusion Criteria:

* Patient hospitalized for another disease
* Inability to receive study information and/or understand/speak French
* Inability to give informed consent
* Legal incapacity (people in jail) or under supervision (i.e. guardianship or curatorship)
* Already include in this study on a previous hospitalization
Outcome Study of Endoscopically Inserted Gastrostomy (PEG)Versus Radiologically-guided Insertion of Gastrostomy (RIG)in Children

A gastrostomy is a feeding tube that communicates from the skin directly into the stomach. It is a device frequently used in children that have feeding difficulties or are unable to maintain normal growth via oral feeds. The same device may be inserted in two ways: the percutaneous endoscopic method (PEG) which is guided by the use of an endoscope (flexible camera), or the radiologically inserted method (RIG) which is guided by the use of X-ray imaging. Both methods of insertion have been used in children for more than 20 years, but it is not clear which is the best method. Both methods are associated with complications, including injury to other abdominal organs and leakage leading to sepsis. There are no randomised controlled trials comparing the two techniques.

We aim to compare the outcome of both methods of gastrostomy insertion in children, with emphasis on the complication rates. We have devised a complication score with weightage assigned to each complication according to its severity.

A randomised controlled trial will be performed in children requiring a gastrostomy, 100 per group. The primary outcome will be the overall total complication rate.


Eligibility Criteria:
Inclusion Criteria:

* any child referred for gastrostomy insertion

Exclusion Criteria:

* the child has gastro-esophageal reflux and is being considered for anti-reflux surgery
* previous gastrostomy or fundoplication
* previous extensive abdominal surgery
* the child requires a concomitant major procedure on the gut or other intra- abdominal organs
Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study

This is an open label, prospective study to evaluate therapeutic potential of Tazarotene 0.1% cream for the treatment of Stage I-IIA CTCL. Patients with Stage I-IIA disease are enrolled into the study. Tazarotene will be used for up to 24 weeks and patients will be followed for up to 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Stage I-IIA CTCL must be at least 18 years of age with a skin biopsy prior to enrolment confirming the diagnosis of mycosis fungoides.

Exclusion Criteria:

* Patients with Stage \>IIA CTCL at the time of enrolment
* Women who are pregnant or planning to get pregnant, or unable/unwilling to use adequate contraception
* Patients who were treated with topical retinoid therapy in the past 3 months
* Patients who received any systemic CTCL therapy or systemic corticosteroid therapy within 30 days of the study start date
* Patients who were treated with systemic isotretinoin or bexarotene within 3 months prior to the study start date, systemic acitretin within 2 years prior to study start date
Observational Study for SIR-Spheres Therapy for the Treatment of HCC Patients in China

Yttrium-90 (y90) Microsphere Injection Solution was approved by the NMPA in 2022. Currently, there is a lack of summary of real-world data in China. Therefore, this retrospective real-world study is intented to explore the characteristics and efficacy of HCC patients treated with y90 in China, aiming to provide reference for guiding and optimizing clinical practices and subsequent confirmatory clinical studies for the treatment of HCC patients in China.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years old;
2. confirmed diagnosis of HCC
3. treated with yttrium-90 during 2023.1.1 - 2024.6.30 and assessed at least once for tumor response within 6 months following treatment

Exclusion Criteria:

no formal exclusion criteria in a real-world study
The Efficacy and Safety of the Loading Dose of Tranexamic Acid in Scoliosis Surgery During Perioperative

This study intends to make full use of the advantage of spinal orthopedic surgery in our medical center.Analyze the blood loss and blood coagulation function and the influence of safety of load dose tranexamic acid (TXA) in scoliosis surgery during perioperative.


Eligibility Criteria:
Inclusion Criteria:

* age:18-60 years old
* American Society of Anesthesiologists (ASA):I-II
* The spinal orthopedic undergoing elective surgery

Exclusion Criteria:

* Severe cardiopulmonary dysfunction
* Blood coagulation dysfunction
* Disorders of liver and kidney function
* Tranexamic acid allergies
* The history of pulmonary embolism and venous thrombosis of lower limbs
* Anticoagulant drugs and nonsteroidal anti-inflammatory drugs in 7 days
Impact of Macronutrient Composition of Energy-restricted Diet and Exercise on Body Composition and Appetite Hormones.

The main aim of this study is to investigate the effect of energy-restricted low and high-carbohydrate diet combined with exercise training on appetite regulatory hormones, subjective appetite and energy intake in overweight and obese women. In addition, since the macronutrient composition of meals and exercise impacts biomarkers of cardiovascular disease, the impact of these interactions on metabolic risk factors of cardiovascular diseases will also be investigated .

This will be a block randomised parallel study, with one group of participants undergoing exercise training combined with the consumption of a calorie-restricted high CHO-low FAT diet and another group undergoing exercise training with consumption of a calorie-restricted low CHO-high FAT diet. The interventions will last for 4 weeks. Prior to and after the interventions participants will undergo a 5-hour experimental trial, which will involve body composition measurements by the D2O method, appetite hormones, insulin via blood collection and subjective appetite via a visual analogue scale. During the experimental trials, participants will consume breakfast and ad libitum buffet-style lunch.

Prior to the first experimental trial, participants will be subjected to a screening process followed by a preliminary exercise test in the metabolic research unit at New Lister Building (NLB), Glasgow Royal infirmary (GRI). Participants will also be asked to record their food and drink consumed for 4 days (3 weekdays and 1 weekend) prior to and during the four last days of the intervention. By following this step, individual diets will be designed based on participants preferences with restricted energy intake and different macronutrient compositions. Dietary intake records will allow a comparison of participants' calorie intake before and after the intervention.

During intervention participants will consume either energy-restricted low CHO-high FAT or energy-restricted high CHO-Low FAT diet and exercise (brisk walking) while wearing a heart rate monitor 3 times a week after 5 minutes of warm-up, and 5 minutes The duration of the brisk walking will increase after week one from 30 to 45 minutes and to 60 minutes at week three and four. Participants will be advised to cool down after the brisk walking session. During the intervention, participants will be encouraged to avoid alcohol consumption. In case this was not possible, a maximum amount of two units will be allowed per week.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Female
* BMI of ≥25.0 kg/m2.
* stable body weight for at least three months preceding the study

Exclusion Criteria:

* smokers and have
* irregular menstruation cycle,
* use any type of medication,
* exercising more than 75min a week,
* are pregnant or lactating.
* on any dietary supplements at the time of the study,
* are vegetarian or are following any diet other than the typical Western diet.
Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

Effect of perineurial dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

This study proposes to explore the effect of perineurial Dexmedetomidine on the duration of erector spinal plane block for pediatric idiopathic scoliosis surgery.

Children need good analgesia after scoliosis surgery. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexmedetomidine, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

Eligibility Criteria:
Inclusion Criteria:

* children scheduled for idiopathic scoliosis surgery
* age \>10 and \<18 years

Exclusion Criteria:

* age \< 10 years
* age \< 18 years
* infection at the site of the regional blockade
* coagulation disorders
* immunodeficiency
* ASA= or \>4
* steroid medication in regular use