cyrilzakka/clinical-trials huggingface dataset:
Resilience and Modification of Brain Control Network Following November 13

This is a multiwave longitudinal neuroimaging study in a cohort of direct survivors of 11/13 Paris terrorist attacks. Both structural and functional brain imaging data will be collected at 8-12 months, 3 years, and 6 years after trauma in exposed participants as well as in control non-exposed participants. This project will capitalize on recent evidence showing that healthy participants can prevent unwanted images from entering consciousness using inhibitory control and memory suppression techniques, disrupting traces of the memories in sensory areas of the brain, and weakening their vividness and later reentrance. This process is believed to be affected in Post-traumatic stress disorder (PTSD) which is characterized by anxiety and persistent intrusive memory of the traumatic event with highly distressing contents. This project will thus provide a unique opportunity to observe the online and structural dysfunctions of intrusion control network following a severe psychological trauma and how such process may contribute to recovery and psychopathological dynamics. In addition, the disruption of social cognition and emotional processing following PTSD will also be investigated in relation to disrupted inhibitory control functioning.


Eligibility Criteria:
Inclusion Criteria:

* Participants between 18 and 55 years old.
* Present at the scene of the attacks the evening of 13 November 2015 or inhabitant of one of the neighbourhood affected by the attacks (exposed group), or persons were not in Paris on the evening of the attacks and not residing in Paris and its region (unexposed group).
* Affiliated to the French national health care system
* Have a good knowledge of the French language
* Right-handed
* Body mass less than or equal to 35kg/m2
* Signed written consent form

Exclusion Criteria:

* Pregnancy or intent to get pregnant
* Person deprived of their liberty
* Person admitted to a health or social institution for purposes other than research
* Minor
* Person subjected to an exclusion period related to another protocol
* History of severe psychiatric disorders before the attacks : psychotic disorders, bipolar disorder, obsessive compulsive disorder and / or substance use disorders (excluding tobacco addiction)
* Use of medication that may interfere with cognitive or cerebral functioning
* Presence of visual or hearing troubles that may compromise participant's ability to participate in the study
* MRI Contraindications
A Study to Determine the Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Dark Circles

This is a multicentre, open label, randomized, pilot study to evalute safety and efficacy of Human Platelet Lysate (HPL) in subjects with Periorbital Hyperpigmentation. The study is being conducted at 2 centers in India.The primary endpoints are Physicians and Patient Self assessment score. The secondary endpoints are improvement in photographic assessment form randomization to end of study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects (male and female), aged 18 to 55 years (both inclusive) with Periorbital Hyperpigmentation.
* Subject willing to refrain from any other treatment of Periorbital Hyperpigmentation during entire study duration.
* Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion Criteria:

* Subjects aged less than 18 and more than 55 years
* Subjects with history of connective tissue disease.
* Subjects with metabolic or hematopoietic disorders
* Subjects unwilling to or unable to comply with the study protocol.
* Subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30 days.
A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion

The aim of the THEIA study is to determine if Alteplase administrated within 4.5 hours improve visual deficit due to acute CRAO with a good safety profile.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged up to 18 years
* CRAO diagnosis by fundoscopic examination or non-mydriatic retinophotography (NMR) performed by an ophthalmologist.
* Blindness defined according to WHO classification as visual acuity \<1/20 (20/400).
* Treatment intervention should be initiated by a stroke team as quickly as possible and within 4.5 hours from symptom onset.
* No clinical (e.g headache with jaw claudication or scalp tenderness, no temporal pulse) or laboratory evidence (elevated CRP) of giant cell arteritis
* No clinical or radiological evidence of stroke within the last 3 months.
* Patients covered by health care insurance (social security)
* Written informed consent obtained.

Exclusion Criteria:

* Symptoms onset more than 4.5 h prior to infusion start or undetermined time of symptom onset.
* Minor VA deficit or VA rapidly improving before start of infusion.
* CRAO without foveal ischemia.
* Other retinal vascular disease: occlusion of branch of the CRA without significant VA loss, occlusion of the retinal vein, proliferative diabetic retinopathy or any other severe retinopathy.
* Clinical or laboratory evidence of temporal arteritis.
* Evidence of ICH or ischemic stroke on the pre-administration CT scan or MRI.
* Pregnant or lactating women
* Minors
* Adults under guardianship or trusteeship
* Any contraindication to alteplase
* Any contraindication to aspirin
Low-level Laser Therapy in Wrist Fractures

Approximately 15,000 persons in Norway suffer from wrist fractures during a year, making it the most prevalent fracture in this country. Treated conservatively, a cast is used for 4-6 weeks before removal. After discontinuation of the cast, physiotherapy is implemented to aid in improving range of motion and regaining function of the injured wrist. The pain after injury can affect the patient to a greater or lesser extent, and it is common to prescribe sick leave for shorter amounts of time after the injury.

Studies suggest that a physiotherapy intervention with Low Level Laser therapy (LLLT) may reduce pain and swelling after acute trauma, and potentially promote healing. The aim of this study is to evaluate the effect of LLLT on pain and function at 2, 4, 8 and 26 weeks after injury.

Patients with wrist fractures are recruited from Bergen Municipal Emergency Ward, where they are randomly divided into two groups with concealed allocation. The fracture is immobilized with a cast, with a small opening where Low Level Laser therapy can be administered in skin contact. The patients will receive treatment 3 times a week, for 3 weeks. After discontinuation of the cast, the patients swelling, pain, grip strength and function of the wrist is measured. The patients will meet for follow-up controls until 26 weeks after injury.

Eligibility Criteria:
Inclusion Criteria:

* Patients with distal radiusfraktur, with or without ulna fracture Colles' fracture
* The breach must be closed
* Under 10 degrees dorsal displacement of radius
* Under 5mm shortening of the radius
* Under 3 mm step in the joint
* 18+ years

Exclusion Criteria:

* People who do not speak Norwegian or English
* If the patient is pregnant
* Patient with Smith fracture
* Wounds over fracture area
* If the patient have a peripheral nerve injury
* If the patient had (previously) operated wrist
* Persons with verified osteoporosis at the time of injury, systemic inflammatory disease (rheumatism), mental illness, stroke, Parkinson's disease, multiple sclerosis, cancer or congenital malformations in wrist
* If the laser treatment can not be started within 3 days after fracture
VISN 19 MIRECC Research Database

The VISN 19 MIRECC is involved in research concerned with suicide prevention in high risk populations (e.g., history of traumatic brain injury, post-traumatic stress disorder); Recruitment for future studies will continue with a similar focus. The aim of this protocol is for the VISN 19 MIRECC Research Database (V19-MRD), to have a data repository of participants for possible recruitment from other studies being conducted at the VISN 19 MIRECC. The VISN 19 MIRECC conducts numerous research projects under the review of COMIRB and the VA R\&D.

This protocol seeks to formally create the database that will store demographic data. The data will be used by VISN 19 MIRECC Investigators solely for recruitment purposes for future studies.

The repository data will include:

1. Data regarding individuals in existing study databases who have already provided permission to have their information stored and used for future recruitment into VISN 19 MIRECC research studies (specific data elements to be collected will be articulated below).
2. Data of individuals to be collected and saved to use for future recruitment into VISN 19 MIRECC research studies.

A restricted section of the V19-MRD will contain V19-MRD identification numbers and identifying data including name (first, last, middle initial), Social Security number, phone number(s) (primary and secondary), date of birth, and mailing address. A less restricted section of the V19-MRD will contain V19-MRD identification numbers, the COMIRB protocol number of the study the participant was recruited from, gender, year of birth, and criteria identifiers marked as present or absent (i.e., history of medical and mental health conditions, history of suicide - thoughts/behaviors, history of combat experience, and presence of imaging results).

The V19-MRD would enhance current research strategies by first allowing VISN 19 MIRECC Investigators an efficient method to conduct preliminary or ongoing investigations to determine if: 1) sufficient populations exist to conduct a study; or 2) potential participants meeting specific study criteria are included in the database who could be contacted regarding study participation. Second, with an approved protocol, the V19-MRD contact section of the database could be used to facilitate mailings to potential participants.

Eligibility Criteria:
Inclusion Criteria:

* Being a Patient at the Denver VA Medical Center
* 18 years or Older
* Participated in another study at the VISN 19 MIRECC

Exclusion Criteria:

* Not a Patient at the Denver VA Medical Center
* Younger than 18 years
* Never Participated on a Study Within the VISN 19 MIRECC
Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination

The purpose of this study is to assess the safety and efficacy of Timolol Maleate treatment for different depth of infantile hemangioma based on B-ultrasonography. Based on the depth of hemangioma, patients will be proactively allocated to two groups. And then, all patients in both groups will receive topical timolol treatment in the same protocol and dosage.

Primary: Describe the efficacy of 0.5% topical timolol maleate drops in different depth of infantile hemangioma as assessed through IB-ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Infants of 0 to 6 months of age
* Skin Infantile hemangiomas (IHs) in the proliferation stage without prior treatment
* IHs with a surface area of less than 1% of body surface area
* Skin type III/IV

Exclusion Criteria:

* Ulcerated IHs.
* Unsuitable for topical Timolol treatment due to anatomical location of lesion, eg.

periorbital and lip IHs.

* Patients with severe systemic or congenital disease which may affect the patient's safety in this study
Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration

Evaluative pilot study for safety and feasibility with administration of autologous bone bone marrow derived mononuclear cells by endoventricular catheter into the normal border zone fo the ischemic lesion.


Eligibility Criteria:
Inclusion Criteria:

* LVEF \<40%
* PCI at latest 6 hours after infarction
* BMI \>20 kg/m² and \<30 kg/m²

Exclusion Criteria:

* PCI elder than 14 days
* relevant valvular disease
* left ventricular dysfunction caused by other reasons than ischemic cardiomyopathy
* history of stroke, chronic atrial fibrillation, multivessel disease, thromboembolic event
* scheduled for CABG
* DM Type 1 \& extensive hypercholesterinemia
* pacemaker
* systemic disease
* Pregnancy
Sex, Psychopharmacology, and Diabetes

The term sexual (SD) dysfunction covers conditions that prevent people from having a satisfactory sex life. SD is a frequent and sometimes debilitating complication of mental illness and a known adverse reaction to psycho-pharmacological treatment. SD is also associated with diabetes, a common somatic comorbidity in psychiatric patients. SD is associated with both reduced quality-of-life and reduced treatment adherence, yet SD is far too rarely addressed between the patient and the healthcare professional in clinical consultations.

The purpose of the study is to investigate whether targeted education of patients with schizophrenia and diabetes/prediabetes and/or their healthcare professionals in causes and management of SD:

* Increases the number of systematic examinations of sexual side effects,
* Causes changes in the psycho-pharmacological treatment, and
* Reduces the severity or perception of sexual side effects.

The study is a multicenter Randomized Controlled Trial (RCT) with four arms, in which the educational intervention is provided to patients, healthcare professionals, or both groups. The effect of the educational intervention is compared to a non-educated control group. The study is expected to include 192 patients recruited from 16 assertive community treatment centers evenly distributed in four Danish regions.

The study is part of an interdisciplinary project named SECRET. The educational intervention was developed in an ethnographic pre-study incorporating stakeholder engagement. Parallel to the present RCT, an ethnographic field study will be carried out to broaden the perspective on the effects of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* A diagnosis in the schizophrenic spectrum (ICD10 F2x)
* One of the following:

  1. A diagnosis of diabetes (ICD10 E10x, E11x, E12x, E13x, 14x)
  2. A current or previous prediabetes defined as an HbA1c between 39-47 mmol/mol (both included) measured in at least two blood samples collected with ≥3 months intervals as part of the patient's routine clinical monitoring
  3. Obesity defined as a Body-Mass Index (BMI) ≥30 kg/m2
* Ongoing treatment with at least one antipsychotic agent
* A SD that can be rated using Changes in Sexual Function Questionnaire-14 (CSFQ-14)

Exclusion Criteria:

* Incapacitated or subject to mental health probation
* Unable to speak danish
A Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease (CKD) From Congenital Anomalies of the Kidney and Urinary Tract (CAKUT).

A phase 1, open-label safety, tolerability and early efficacy study of a Renal Autologous Cell Therapy (REACT) in patients with Chronic Kidney Disease from Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) (REGEN-004)

It is anticipated that all subjects will receive two planned Renal Autologous Cell Therapy (REACT) injections to allow dose-finding and evaluate the duration of effects. The scientific rationale, based on non-clinical studies, is that the biologically active component of REACT (homologous, autologous, SRC) delays progression of experimental models of Chronic Kidney Disease (CKD) by augmenting renal structure and function. As a result, the more cells that can be infused, the greater the potential improvement in renal function.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is male or female, 18 to 65 years of age on the date of informed consent.
2. The patient has a documented history of a corrected abnormality of the kidney and/or urinary tract (CAKUT) leading to renal dysfunction.
3. The patient has an established diagnosis of Stage III/IV CKD not requiring renal dialysis.
4. The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s).

Exclusion Criteria:

1. The patient has a history of renal transplantation.
2. The patient has a diagnosis of hydronephrosis, SFU Grade 4 or 5.
3. The patient has an uncorrected VUR Grade 5.
4. The patient has a diffuse cortical thickness throughout the kidney measuring \< 5 mm on MRI that prevents safe cortical biopsy.
The Effect of Vitamin D Supplements on Vitamin D Status, Cardiometabolic Health and Immune Defense in Danish Children

The main purpose of this study is to investigate whether and in which doses vitamin D intake is needed in order to maintain an adequate vitamin D status in 4-8 year-old Danish children during wintertime.

The main objective of ODIN Junior is to investigate whether and in which doses vitamin D intake is needed in order to maintain serum 25(OH)D concentrations above deficiency and insufficiency cut-offs (30 nmol/L and 50 nmol/L, respectively) in 4-8 year-old Danish children during the winter time. The children will be randomized to receive tablets with either 10 micrograms/day or 20 microgram/day of vitamin D3 (cholecalciferol), corresponding to one and two times the recommended daily intake in children, or placebo for 20 weeks. Measurements and blood sampling will be performed before the beginning and by the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* 4-8 years at the start of the intervention
* healthy
* of white, Danish/European origin
* children must be Danish-speaking
* parents must read and speak Danish
* not planning a winter vacation south of a latitude of 51°North (corresponding to Surrey, England)

Exclusion Criteria:

* diseases that may interfere with vitamin D or calcium metabolism
* intake of medication known to affect vitamin D or calcium metabolism
* use of vitamin D containing supplements ≥ 4 days/week the last 8 weeks before intervention start and use of any vitamin D containing supplements the last 4 weeks before intervention start
* concomitant participation in other studies involving dietary supplements or blood sampling
* serum calcium \> 2.7 mmol/L at baseline
Is the Current Threshold for Diagnosis of "Abnormality", Including Non ST Elevation Myocardial Infarction, Using Raised Highly Sensitive Troponin Appropriate for a Hospital Population? The CHARIOT Study

Currently when defining the upper limit of normal (ULN) or 99th percentile of a troponin assay manufacturer's use a healthy population traditionally aged 18-40. The 99th percentile value is the recommended value to use when diagnosing patients with an acute myocardial infarction. With the advent of the new highly sensitive troponin assays it has become clear that many patients have a troponin level above the 99th percentile when they have not suffered a myocardial infarction. We believe part of the problem with interpreting the the troponin values for patients is that the 99th percentile value which determines the ULN has been derived from population that is very different to the hospital population of patients. This study aims to demonstrate what the 99th percentile is for the population of people who use the hospital services who are traditionally older and have more comorbidities when compared to the population traditionally used to define the 99th percentile of a troponin assay.

An amendment was approved to follow-up patients' clinical outcomes at 1 year using NHS Digital data.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged 18 years or older).
* Biochemistry blood sample already taken as part of routine clinical care.

Exclusion Criteria:

* Individuals aged less than 18 years old.
* No biochemistry blood sample taken as part of routine clinical care.
* Biochemistry samples requested by General Practitioner
Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi

The administration of néfopam after initial treatment by kétoproféne, could obtain, in patients remaining pain and classically need morphine, analgesia at least the same as morphine alone. The use of néfopam second line after ketoprofen could reducing (or even eliminating) the need for morphine (and its side effects), allowing a reduction in the length of stay of patients in the emergency unit.

The main objective is to show that the addition of a néfopam initial treatment with the kétoproféne, reduces, in patients with ureteral calculi, the percentage of patients requiring the use of a treatment by morphine.

The secondary objective is to reduce the side effects caused by the morphine, shorten the time to install the appropriate level of analgesia while reducing the risk of failure of the titration morphine, reduce the time spent on titration of morphine and reduce the length of stay patient intake in emergency unit.

The study is prospective, parallel, double-blind, randomized, placebo-controlled analysis with intent to treat. There are 2 groups:

* A group N: néfopam
* A group P: placebo And all the patient receive, before randomization, 100 mg of ketoprofen (Profenid ®) on 20 minutes.

The number of subjects is 52.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 50 years old.
* Admitted to the emergency room for typical ureteral calculi with severe pain (VAS \> or = 60), and microscopic hematuria in the strip without signs of urinary complications.
* Preliminary Agreement patient.

Exclusion Criteria:

* Patient disagree.
* Pregnant women (sought by the questioning).
* Fever \> 38 ° C.
* Leucocyturie or nitriturie (dipstick).
* Contraindication to ketoprofen.
* Contraindication to néfopam.
* Contraindication to morphine.
* Contraindication linked to drug interactions as mentioned in the Summary of Product Characteristics of the Authorization for placing on the market of Acupan ®.
* Treatment opioid analgesics, nonsteroidal anti-inflammatory or inflammatory or paracetamol in the previous 12 hours.
* Secondary exclusion to a urinary tract infection or systemic.
Serrated Lesions Detection With Endocuff-assisted Colonoscopy

Colorectal cancer (CRC) is a leading cause of morbidity and mortality worldwide, especially in Western countries. CRC is currently considered a preventable disease and screening has been endorsed by several societies, since it has been shown that screening and surveillance are effective in reducing both CRC incidence and mortality. However, recently, concern has risen regarding colonoscopy effectiveness, especially in the right colon. The most accepted explanation for this effectiveness variability is attributed to sessile serrated lesions (SSL), which are more frequent in the proximal colon, more difficult to detect because of their flat morphology and associated with interval CRC, which is the occurrence of CRC after screening colonoscopy and before the next scheduled procedure. Several techniques are emerging to increase the sensitivity of colonoscopy for pre-cancerous lesions, especially adenomas. Recently an endoscopic cap, the Endocuff, was developed to improve adenoma detection. Several studies demonstrated improved adenoma detection with Endocuff-assisted colonoscopy when compared with conventional colonoscopy. Still, the available data for its' role in detecting SSL is very limited. The aim of this randomized controlled trial is to evaluate the effectiveness of Endocuff-assisted colonoscopy in detection of colorectal SSL.


Eligibility Criteria:
Inclusion Criteria:

- Outpatients undergoing elective colonoscopies

Exclusion Criteria:

* Known polyposis syndromes
* Personal colorectal cancer history
* Previous colorectal surgery
* Severe diverticulosis
* Colonic stricture
* Inflammatory bowel disease
* Primary sclerosing cholangitis
* Pregnancy and breastfeeding