cyrilzakka/clinical-trials huggingface dataset:
Non-invasive Measurement of Cerebral Dynamic Autoregulation

The overall objective of this study is to evaluate the use of diffuse correlation spectroscopy to non-invasively measure dynamic cerebral autoregulation in subjects with vascular risk factors. Optical cerebral blood flow measurements will be correlated with changes in arterial blood pressure to assess how CBF is maintained in response to changes in ABP, and will be compared to transcranial doppler reference measurements.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 50 years
* Positive history of at least one of the following vascular disk factors: hypertension, diabetes, hyperlipidemia, coronary artery disease, atrial fibrillation, prior myocardial infarct, transient ischemic attack, or history of smoking

Exclusion Criteria:

* Vascular risk factor subjects:

  1. Pregnant women
  2. Prisoners
  3. Prior neurosurgical procedure or traumatic brain injury, including hemicraniectomy or other skull defect
  4. Prior history of ischemic or hemorrhagic stroke
  5. Prior lower extremity amputation
  6. Peripheral vascular disease
Timing of Renal Replacement Therapy In Mechanically Ventilated Patients

This is a randomized controlled study that will be conducted on acute kidney injury (AKI) patients, who are mechanically ventilated, to assess the impact of implementation of early renal replacement therapy (RRT) compared to late RRT on patients outcome.

The study subjects will be randomly divided into two groups (arms).

The first one will be patients who will receive early renal replacement therapy (RRT) according to predefined criteria that will be illustrated later.

The other group of patients will be those who receive late RRT according to the absolute indications of emergency hemodialysis i.e. severe hyperkalemia, life-threatening acidosis, uremic encephalopathy or pericarditis in addition to intractable pulmonary edema.

Appropriate randomization technique will be applied. A computer-based program will be used to perform the randomization procedure.

Eligibility Criteria:
Inclusion Criteria:

* All patients must be on invasive mechanical ventilation.
* Patients in AKI stage 2 , according to KDIGO classification.
* Recruited subjects will include either those who present with AKI on their ICU admission or those who develop AKI during their ICU stay

Exclusion Criteria:

* Those who are known to be in grade 5 CKD according to KDIGO classification. All other grades of CKD from 1 to 4 will be included only if they develop or present with stage 2 AKI on top of their CKD grade
* Those who develop AKI due to obstructive or traumatic causes.
* Patients with septic shock who are on high doses of vasopressors or inotropes (norepinephrine infusion more than 1 mcg/kg/minute, dopamine or dobutamine infusion more than 5 mcg/kg/minute).
* Pregnant females
Anterior Mediastinum Teratoma: A Case Report

The investigators report a case of a 39-year-old man who presented an anterior mediastinal cystic mature teratoma. Those kind of tumor contain elements derived from more than one of the three primary germ layers (ectoderm, mesoderm, endoderm), frequently arranged in a haphazard manner. They arise from totipotent cells and, therefore, are primarily found in gonads, and more rarely in primitive cells kidnapped in other parts of the body. The tissues are immature to well differentiated and foreign to the anatomic site. Mature teratomas are either cystic or solid, although the cystic presentation predominates in gonadal sites. Benign teratomas are the most common mediastinal germ cell tumor, accounting 70% of the mediastinal germ cell tumors in children and 60% of those in adults. Immature teratomas are potentially malignant tumors; their prognosis is influenced by the anatomic site of the tumor, patient age, and the fraction of the tumor that is immature. Treatment of benign mediastinal teratoma includes complete surgical resection, with results in a excellent long-term cure rates. Complete resection of teratomas should be the goal of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mediastinum teratoma

Exclusion Criteria:

* Tumor absent
The Management of Work-Disability Associated With Co-Morbid Pain and Depression: A Feasibility Study

The purpose of the present study was to conduct a preliminary evaluation the feasibility and impact of a risk-targeted behavioral activation intervention for work-disabled individuals with co-morbid pain and depression.

The design of the study was a single arm non-randomized trial. The sample consisted of 66 work-disabled individuals with co-morbid pain and depression. The treatment program consisted of a 10-week standardized behavioral activation intervention supplemented by techniques to target two psychosocial risk-factors for delayed recovery, namely, catastrophic thinking and perceptions of injustice.

Eligibility Criteria:
Inclusion Criteria:

* 1) work-disability greater than 4 weeks associated with a musculoskeletal injury to the back or neck, 2) a score above clinical threshold on a self-report measure of depression, and 3) between 25 and 55 years of age.

Exclusion Criteria:

* 1) Clinical evidence of vertebral fracture, disk herniation, infectious disease, or rheumatoid arthritis: 2) Evidence of chronic pain pre-dating the current injury: 3) Evidence of loss of consciousness at the time of injury: 4) Previous musculoskeletal injury sustained within the past 12 months: 5) Evidence of any medical condition that might contraindicate participation in physical activity: 6) Illiteracy or severe cognitive impairment.
Efficacy and Safety Clinical Trial of the Combination of Acetylsalicylic Acid, Sodium Bicarbonate and Citric Acid, Produced by Geolab Pharmaceutical Industries Ltd., Compared to Acetylsalicylic Acid (Aspirin ® - Bayer) in Patients With Episodic Tension-type Headache.

This study aims is to evaluate, two hours after a single administration, the rate of sustained response produced by the association Geolab consisting of acetylsalicylic acid, sodium bicarbonate and anhydrous citric acid - oral powder, with the active comparator acetylsalicylic acid (Aspirin ® -- Bayer) - a simple tablet for the treatment of acute pain in patients with mild to moderate CTTE, using for both the visual analog scale pain - VAS.

The secondary objectives of the study are to evaluate:

* Modification of gastric pH after administration of drugs by measuring with gastroesophageal pH Monitor, comparing the results between the groups;
* The incidence of administration of rescue medications, through the accounts of patients and researchers, comparing the results between the groups;
* The percentage of improvement in time 30, 60, 90 and 120 minutes after administration, using the visual analog scale (VAS), comparing the results between the groups;
* Evaluate the gastric symptoms before and after treatment by clinical investigation of patients, comparing the results between the groups;
* Evaluate the change in associated symptoms (photophobia, phonophobia, nausea, vomiting), using 4-point scale (0 - absent 1 - mild 2 - moderate 3 - severe), comparing the results between the groups;
* Assess the quantitative and qualitative parameters related to adverse reactions, comparing the results between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Agreed to participate in the study expressed by signing the two copies of the informed consent and informed consent (IC) after approved by the IRB;
* Minimum age of 18 years;
* Clinical history of TTH, according to the criteria of the International Classification of Headache of the International Headache Society, in face of crisis.

Exclusion Criteria:

* Headache, migraine
* Chronic Tension-Type Headache (CTTH)
* Altered mental status
* Vital signs changed
* established or suspected pregnancy and lactation
* History of allergy to components of study drugs
* Current treatment with methotrexate
* Current treatment with Antinauseants
* Current treatment with anticoagulants such as heparin or coumarin-derivative
* gastric or duodenal disorders, chronic or recurrent active
* Liver and kidney disease severe
* Use of medications that have drug interactions with AAS
Arrhythmias in Hemorrhagic Myocardial Infarction During the Acute Post-PCI Phase

Prevalence of Arrhythmias in Hemorrhagic Myocardial Infarction During the Acute Post-PCI Phase


Eligibility Criteria:
1. Age 18-85 years
2. Index STEMI
3. Coronary angiogram with Primary coronary intervention
4. No contraindications for Cardiac MRI
Impact of Infectious Diseases Consultation on Vaccination Coverage Among People Waiting for a Kidney Transplant at the Clermont-Ferrand Hospital

Solid-organ transplant patients are at increased risk of infectious diseases. Among this population, infectious diseases may be life-threatening or lead to graft rejection. Their prevention is an important challenge. Despite specific national recommendations, vaccination is underutilized. That is why we propose a dedicated infectious diseases consultation during pre-kidney transplantation assessment.

The main objective of this study is to impove vaccine coverage before kidney transplantation.

Enrollment was based on the waiting list for a kidney transplant. Patients newly listed are invited to participate by the transplant team (nephrology department) ; for those that are already registered, a notification letter is sent to their home.

All patients included must :

* complete a health questionnaire
* take a blood test at day 0 : viral, bacterial and parasitic serologies, QuantiFERON-TB
* take a chest X-ray and dental panoramic Patients randomized in interventional group will be seen in specific infectious diseases consultation at Clermont Ferrand Hospital. A letter of recommendations is sent to nephrologist for patients randomized in group control.

The primary study endpoint (immunization coverage) is evaluated at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18
* On the waiting list for kidney transplantation at Clermont-Ferrand
* Free and informed consent
* Affiliation to a social security system

Exclusion Criteria:

* Patient under 18
* Protected adults (individuals under guardianship by court order
* Pregnant and nursing women
* Prior graft (solid organs or hematopoietic stem cells)
* Absence of consent
Technology in Play for Children With Physical Disabilities: the Dice Model of Play

Play is an important activity for children. Almost all children play, but what is play? It is not easy to define play. In the past, people believed that children played to burn their energy. Now, it is known that play is important for children's growth. Some kids with disabilities cannot play. Many experts use play to teach children specific skills. People often forget that play is a child's right. It is important to help all children play. The first step is to define play and find what features are important in helping a child with a disability play.

There are some models of play. But they are not complete. They do not look at play as a whole. Some models are just about playfulness, and some are about playing with others. Having a model that defines play helps researchers and clinicians think about play and the different parts of it. Then, when a child cannot play, experts can fix the part that is not working. Investigators want to introduce a model of play in this project. Investigators want to edit and complete it in three steps. First, Investigators will ask parents and children with disabilities about things that help or do not help them play; then, investigators will give Lego robots to kids that they will build with help and play with them for a few weeks. And at the end, investigators will ask therapists and other experts about our model of play. This model will be edited during the study.

The study is designed in three phases, employing a mixed-method approach that integrates qualitative and quantitative methods. Phase 1 involves exploring the alignment of the Dice Model of Play with the experiences of 10 children (aged 3-8, diagnosed with different abilities) and their guardians through semi-structured interviews and content analysis; Phase 2 examines the practical application of the model with a cross-over design. Up to 20 children with different abilities will build their Lego robots within a co-design and will play with that robot for four sessions. The other group will play with conventional toys for four sessions. They will switch after finishing those sessions. Sessions will be directed by a master of occupational therapy student supervised by Dr. Jacquie Ripat, a registered occupational therapist in Manitoba. Assessments will be Test of Playfulness (TOP), enjoyment (PPE_DC), and play skills (ChIPPA-2) three times at the start, switching point, and last session. A go-along interview will be conducted in the co-design. Lastly, Phase 3 seeks expert opinions on the revised Dice Model of Play's clarity, relevance, and applicability, using online focus groups with professionals in occupational therapy, psychology, and computer science. The study aims to modify and enhance the model based on the findings from these phases.

Eligibility Criteria:
Inclusion Criteria:

* Having a disability or typically developed
* Between 3 to 8 years old
* Speaking and understanding English or Persian
* Living in Winnipeg

Exclusion Criteria:

* Not receiving play therapy within the last three months
Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE)

Eligible patients with high risk colorectal malignancy (T3/4, spread greater than 5mm, EMVI positive) will have additional surveillance of breath hold T1, T2 and DW-MRIs (no IV contrast) post surgery six monthly for three years.

Findings of liver MRIs as reported by radiology PI will be shared with their local MDT who make decisions as appropriate, including the management of any identified liver metastases, according to local protocol.

A phase II multicentre, interventional study to determine if additional staging at diagnosis with liver DW-MRI will diagnose more synchronous metastases than CT alone in patients with high risk colorectal cancer. Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local policy.

Eligibility Criteria:
Inclusion Criteria:

1. Have a high risk primary colorectal malignancy
2. Have a negative CT or includes no confirmatory evidence of liver metastases
3. Is able to undergo treatment if liver metastasis is found
4. Have provided written informed consent to participate in the study
5. Be aged 16 years or over

Exclusion Criteria:

1. Have had a previous colorectal malignancy
2. Have metastatic disease
3. Have a synchronous second malignancy
4. Are contraindicated for MRI
5. Has a T3b or below low rectal tumour without EMVI or N1c
Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 in Type 2 Diabetes

This trial is conducted in Europe. The aim of this clinical trial is to compare the pharmacodynamics (i.e. the glucose-lowering effect of the study medication over the entire observation phase from the time of administration and the efficacy period) and the pharmacokinetics (i.e. amount of the study insulin that can be determined in the blood) of a treatment with biphasic insulin aspart 30 (BiAsp 30) administered once, twice or thrice daily and biphasic human insulin 30 administered once daily in type 2 diabetic subjects


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
* Type 2 diabetes mellitus diagnosed for at least 12 months prior to screening
* HbA1c value between 7% and 10.5% (both inclusive) at screening
* Any insulin treatment for at least 3 months prior to screening
* Body mass index (BMI): 25 - 40 kg/m2

Exclusion Criteria:

* Use of any oral antidiabetic agent within the past 6 months
* Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening
* Cardiac disease: NYHA class III or IV chronic heart failure (CHF), unstable angina, and/or any myocardial infarction (treated or untreated) within 6 months prior to screening
* Hepatic insufficiency (ALT or AST greater than or equal to 2 times the central laboratory's upper reference limit)
* Renal insufficiency (serum creatinine greater than or equal to 1.6 mg/dL for males; greater than or equal to
* Recurrent hypoglycaemia or hypoglycaemic unawareness
* Anaemia (haemoglobin less than 13.0 mg/dL in males and less than 12.0 mg/dL in females) (WHO criteria)
* Use of any systemic or topical medications (prescribed or non-prescribed) which may alter glucose metabolism (other than insulin products), including but not limited to: systemic or inhaled glucocorticoids, anabolic steroids, non-selective beta-blockers
* History of substance (e.g. drugs, alcohol) abuse or a positive result in the urine drug/alcohol screen or consumption of more than 14 units (women) or 21 units (men) of alcohol per week (One unit of alcohol equals about 250 mL of beer or lager, one glass of wine, or 20 mL spirits)
* Smoking of more than 20 cigarettes per day and inability to refrain from smoking during the in-house period
* Known hepatitis or positive serological tests for the hepatitis B surface antigen (HBsAg) or hepatitis C antibodies or HIV antibodies
* Uncontrolled treated/untreated hypertension (systolic blood pressure greater than or equal to 160 mmHg and/or diastolic blood pressure greater than or equal to 95 mmHg)
Acute Effect of Topical Menthol on Carpal Tunnel Syndrome

Topical menthol gels are classified 'topical analgesics' and are used to relieve pain of the musculoskeletal system. However, double-blind randomized controlled trials are lacking. Here the investigators examine - in a double-blind randomized controlled cross-over trial - the acute effect of topical menthol (Biofreeze) and placebo (gel with a menthol scent) on pain symptoms in slaughterhouse workers with symptoms of Carpal Tunnel Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* positive Phalen test
* positive Tinel test
* nocturnal hand/wrist pain
* pain intensity of at least 4 in the hand/wrist
* the pain should have lasted at least 3 months

Exclusion Criteria:

* pregnancy
* life-threatening disease
Glucose Absorption and Gut Hormone Secretion After Gastric Bypass

To investigate the impact of canagliflozin on secretion of gut hormones, in particular glucagon-like peptide 1 (GLP-1) in gastric bypass operated patients.

Glucose is a potent stimulus for GLP-1 secretion after gastric bypass surgery and the SGLT-1 transporter appears to be crucial for this response. The study will investigate the effects of SGLT-1/SGLT-2 inhibition (by canagliflozin) on secretion of GLP-1 and other gut hormones after gastric bypass surgery.

Eligibility Criteria:
Inclusion Criteria:

•Uncomplicated gastric bypass surgery performed minimum 12 months prior to study

Exclusion Criteria:

* Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery
* Pregnancy or breastfeeding
* Haemoglobin levels below 6,5 mM
Study for the Effectiveness of Intensive Therapy Aiming at a Remission of Diabetic Nephropathy

Study for the effectiveness of intensive therapy aiming at the remission of diabetic nephropathy

Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded, randomized intergroup comparison study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with type 2 diabetes
2. Urinary albumin-to-creatinine ratio: \>=300 mg/g creatinine twice in the first morning urine sample
3. Serum creatinine level: =\<2.5 mg/dl
4. Patients aged 20-75 years

Exclusion Criteria:

1. Type 1 diabetes
2. Hereditary diabetes or secondary diabetes
3. Non-diabetic nephropathy
4. Familial hypercholesterolemia
5. Secondary hypertension
6. Unstable angina pectoris or history of myocardial infarction/stroke within 6 months prior to consent acquisition
7. Malignant tumor or life threatening disease
8. History of angioedema
9. Patients undergoing LDL apheresis
10. Biliary system obstruction or severe liver injury
11. Liver dysfunction
12. Allergy for ACE-Is, ARBs or HMG-CoA reductase inhibitors
13. Pregnant or nursing patients
14. Others: patients who are not suitable for this trial
Use of Jumping Mechanography as a Method to Assess Musculoskeletal Status in Older Adults

Decline in muscle function may increase risk of hip fracture and decrease quality of life. Different tests are currently used to measure muscle function but they do not work for all individuals. A test called "jumping mechanography," which measures jumping power, may be useful in more people and obtain better information. This study will help us determine whether this test is able to detect differences between muscle function in younger and older adults, as well as whether it is a safe method to use in all ages.


Eligibility Criteria:
Inclusion Criteria:

1. Women and men aged 20 to 30 or ≥ 60 years
2. Able and willing to sign informed consent.
3. Ability to stand without assistance.

Exclusion Criteria:

1. Acute pain different and/or worse than the individuals chronic baseline pain
2. History of recent trauma to musculoskeletal system
3. Neuromuscular disease impairing balance to the degree of not being able to stand without assistance.
4. History of fragility fracture within the last year
5. Patients with a BMD T-score of less than -3.5 at any measured site and a vertebral fracture.
6. History of severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which might limit the ability to complete this study.
7. Recent history of malignancy with metastasis to the musculoskeletal system.
Modeling and Pharmacological Targeting of Genetic Cardiomyopathy in Children Via Cardiomyocytes Derived From Induced Pluripotent Stem Cells (DMDstem)

Interventional, cross-sectional biomedical study of children with genetic cardiomyopathy and healthy children. The aim is to generate, via induced human pluripotent stem cells (hiPSC), "patient-specific" cardiomyocytes (CMs) (hiPSC-CMs) to study the molecular mechanisms of cardiomyopathies of genetic origin.

Interventional, cross-sectional biomedical study of children with genetic cardiomyopathy and healthy children. The aim is to generate, via induced human pluripotent stem cells (hiPSC), "patient-specific" cardiomyocytes (CMs) (hiPSC-CMs) to study the molecular mechanisms of cardiomyopathies of genetic origin.

The study will be proposed to the parents or legal guardians of the children from 0 to 17 included sent in pediatric cardiology consultation to the University Hospital of Montpellier as part of their usual follow-up or a health check (control) .

The only direct intervention performed on the patient is a venous blood sample. The volume of blood collected will be lower than the thresholds defined in the Decree of December 2nd, 2016 on minimal risks in biomedical research (3 ml).

Eligibility Criteria:
Group 1 : Child with genetic cardiomyopathy

Inclusion criteria

* Child from 0 to 17 years old included
* Bearer or at risk of cardiomyopathy of genetic origin. Written and informed consent of parents or guardians of legal guardians
* Affiliation or beneficiary of a social security scheme

Criterion of non-inclusion

. Cardiomyopathy of non-genetic origin (metabolic, toxic, malformative, etc.)

Group 2 : Healthy child

Inclusion criteria

* Children aged 0 to 17 years old
* Normal assessment: clinical examination, ECG, echocardiography
* Written and informed consent
* Affiliation or beneficiary of a social security scheme

Criterion of non-inclusion

* Heart, muscle or respiratory disease
* Treatment with cardiac resonance
* Other chronic diseases (diabetes, neuropathy, kidney failure, tumor)