cyrilzakka/clinical-trials huggingface dataset:
ICBT for Psychological Symptoms Related to the COVID-19 Pandemic Remaining After Societal Opening

This study aim to investigate the effects of internet-based cognitive behavioral therapy (ICBT) addressing psychological symptoms related to the COVID-19 pandemic and its consequences that remain after societal opening. The target group is adults (18 years or older) who still experience psychological symptoms related to the pandemic and the ICBT consists of eight modules during eight week with weekly support by a therapist. ICBT will be compared to a wait-list control condition. Participants will be recruited in Sweden with nationwide recruitment.

The study is a randomized controlled trial about the effects of ICBT regarding psychological symptoms related to the COVID-19 pandemic and its consequences remaining after societal opening. Primary outcome measures are depression symptoms (measured with Beck Depression Inventory-II) and anxiety symptoms (measured with Generalized Anxiety Disorder-7). Other outcome measures used will for example be about stress symptoms, sleep problems, post traumatic stress symptoms and quality of life.

Because of uncertainties about the psychological effects of COVID-19 pandemic, a transproblematic individually tailored treatment will be used that has been tested in several previous trials and adapted for addressing problems related to the pandemic and its consequences. The study (nor the recruitment within it) has not a focus on whether people have or have not been infected by the COVID-19 virus.

Eligibility Criteria:
Inclusion Criteria:

* Experience mental health problems related to the COVID-19 pandemic and/or its consecuences, which are still experienced as a problem (when the pandemic is not considered as dangerous to the society)
* 18 years or older
* Adequate ability to speak, read and write in Swedish
* Having access to the internet and a smartphone, computer or other device

Exclusion Criteria:

* Severe psychiatric or somatic issues that makes participation harder or impossible (which can include the diagnosis postcovid)
* Ongoing addiction
* Acute suicidality
* Other ongoing psychological treatment
* Recent (within the past 3 months) changes in the dose of psychotropic medication or planned change during the treatment weeks
The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia Symptoms

The purpose of this study is to find out if omega-3 fatty acid supplements are more effective than an inactive placebo at reducing pain, reducing fatigue and elevating mood in patients with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-65.
* A diagnosis of FM according to the American College of Rheumatology classification criteria(Wolfe et al., 1990)
* Negative urine pregnancy test at enrolment and willingness not to become pregnant for the duration of the study.
* Pain levels of at least 4 on 10-cm VAS at the time of recruitment.
* Ability to communicate in English or in French.
* Willing to sign an informed consent.
* If the patient is taking medication or natural health product (excluding omega-3 containing products) to treat fibromyalgia, she must be on a stable regimen for a minimum of two weeks before recruitment and be willing to keep this stable medication or natural health product regimen throughout the study period.
* If the patient is using other therapies to treat fibromyalgia such as TENS, acupuncture, exercise, psychotherapy, massage, physiotherapy, etc, she must be doing so for a minimum of two weeks before recruitment and be willing to continue those therapies throughout the study period.

Exclusion Criteria:

* Use of anticoagulants (Coumadin® or Plavix®), having a bleeding disorder or being scheduled for a surgical procedure. This is because omega-3 fatty acids can prolong bleeding time, although doses we propose to use are safe (see Risks section)
* Allergy to fish, olive oil, medium chain triglycerides, lemon, green tea, vitamin E or tylenol
* Past (within the last year) or present specific dietary supplementation with omega-3 fish oil or other natural health products containing omega-3 fatty acids (e.g. flax seed oil, krill oil, etc) or regularly eating more than two fatty fish meals/week (salmon, mackerel, sardine, flounder, herring, or any other fish considered to have a high level of omega-3 fatty acids).
* Patient enrolled in another research study involving any treatment.
* Patient engaged in active litigation
* Regular use of recreational drugs
* Alcohol consumption \> 10 units/week
* Morbidly obese patients
* Pregnancy or breastfeeding
* Uncontrolled major medical conditions. Neurological problems. Current psychiatric condition. Chronic pain condition other than FM.
Effect of Glutamine on Urinary Incontinence

The objective of this study is to determine to effect of additional oral glutamine to Kegel exercises on pelvic floor strength and clinical parameters of urinary incontinence in females with either urinary incontinence (stress and/or urgency) and pelvic prolapse.

Urinary incontinence is a prevalent and costly condition that affects approximately 38% of older community-dwelling women (age\>60 years). Incontinence predisposes patients to other health problems, contributes to depression and social isolation, is a significant source of dependency among the elderly, and is widely cited as a factor in nursing home admissions. Sarcopenia is age-related and is characterized by loss of muscle mass, strength and endurance. There is not only a decrease in the number of muscle fibers, but also atrophy in the remaining ones. Several studies indicate glutamine supplementations lead to better muscle performance by stimulate muscle producing in extremities. Similarly, we assume glutamine supplementation could increase pelvic muscle mass and improve the pelvic floor strength. From this point, using glutamine supplementation may effect positively on stress, urge or mixed incontinence, and pelvic prolapse.

Eligibility Criteria:
Inclusion Criteria:

* Presence of urinary incontinence and/or pelvic prolapse and/or decreased vaginal muscle strength in gynaecological examination

Exclusion Criteria:

* Uncontrolled diabetes
* Cognitive dysfunction hampering participation in exercise or assessment
Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

To demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard endoscopic retrograde cholangiopancreatography (ERCP) with brushing cytology for diagnosis and early detection of cholangiocarcinoma in patients diagnosed with primary sclerosing cholangitis (PSC).

The primary objective of this study is to demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard ERCP with brushing cytology for diagnosis and early detection of cholangiocarcinoma in patients diagnosed with primary sclerosing cholangitis (PSC).

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of PSC
2. Clinical indication for ERCP per local standard of practice, such as suspicion of potential malignancy based on worsening cholestatic values or clinical presentation (such as itching, cholangitis) or new biliary stricture on trans-abdominal imaging (MRI/MRCP, US or CT) or suspicious cytology
3. Diameter of bile ducts deemed sufficient to accommodate the cholangioscopy system based on imaging performed prior to scheduled ERCP
4. Written informed consent from patient to participate in the study, including compliance with study procedures.

Exclusion Criteria:

1. Contraindication for an ERCP or POCS
2. History of liver transplantation
3. Mass/metastasis extrinsic to the bile duct identifiable on diagnostic imaging
4. History of iatrogenic bile duct trauma, including biliary surgery within 6 months of enrollment
5. INR \> 1.5 or platelets count \< 50,000
6. Age \< 18 years
7. Pregnant women or women trying to become pregnant
Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage

This study evaluates the ability of Magnetic Resonance Elastography non invasive technology to identify the liver fibrosis stage in patients with chronic liver diseases compared to Shear Wave Elastography and/or Liver Biopsy.

Recent advances in magnetic resonance imaging (MRI) of the liver have led to improvements in diagnosis of chronic liver diseases. Detection and staging of liver fibrosis has become important; however, until about the last decade, it depended on an invasive liver biopsy. Liver biopsy is limited by high cost, low patient acceptance, interobserver variability during microscopic evaluation, sampling error, poor reproducibility, and, importantly, an invasive nature with a complication rate of 3% and a mortality rate of 0.03%. With the emergence of elastography techniques, the need for liver biopsy has rapidly diminished for diagnosis of clinically significant liver fibrosis. Magnetic Resonance Elastography has gained increasing popularity in recent years, in large part due to its higher technical success and ability to overcome some of the weaknesses of ultrasound-based methods for assessing liver fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic liver diseases

Exclusion Criteria:

* Patients who don't have chronic liver diseases
Evaluation of Vidiac Scores of Obese and Non-obese Patients Intubated by Videolaryngoscopy

The aim of the study was to observe the vidiac score values of only patients with obesity as a risk factor for difficult intubation. Secondly, it was aimed to evaluate the number of intubation attempts and intubation time, vidiac scores between non-obese and obese patients and to reveal the differences, if any.


Eligibility Criteria:
Inclusion Criteria:

* All patients to be operated under general anesthesia and endotracheal intubation

Exclusion Criteria:

1. under 18 years old
2. The patient's refusal
3. Difficult airway story before
4. Congenital or previous airway anatomical disorder
5. Patients who have undergone airway surgery
6. Patients with a mass in the head and neck region
Study of Comparison Between Pentacam and locs3

Hypothesis: There is no difference between pentacam scheimpflug system and locs3 in grading of cataract.

Major aims:

1. research the efficiency of pentacam scheimpflug system in lens density measurment.
2. To compare the pentacam with the locs3 in grading of cataract.


Eligibility Criteria:
Inclusion Criteria:

* cataract patient
* age\>18

Exclusion Criteria:

* pregnant women
* any disease of the eye except for cataract
* patients who are ineligible by law to take decisions by themselves.patients who have a custodian.
Decision Aid for Cigarette Smokers Undergoing Surgery

Smokers have three choices when faced with surgery: keep smoking, quit for a short time around surgery or quit for good. In the first specific aim, a decision aid was designed to help facilitate the discussion of these choices between smokers and healthcare providers. This second aim will test whether this decision aid improves the decisional quality compared with standard methods used to discuss perioperative smoking.


Eligibility Criteria:
Inclusion Criteria:

* Current cigarette smoker
* Scheduled to undergo elective surgery at Mayo Clinic Rochester
* Age 18 years or older
* Able to fully participate in all study aspects

Exclusion Criteria:

* Unavailable for telephone follow-up
Pathology of Helicases and Premature Aging: Study by Derivation of hiPS

Topic of this work is the involvement of replicative helicases in human premature ageing syndrome. Replicative helicases are ubiquitous and essential during numerous reactions of the DNA metabolism.

The family of replicative helicases (RecQL) is involved in the replication/repair of the DNA and in the telomere maintenance. There are 5 enzymes in human and 3 of them are involved in clinically recognizable syndromes: WRN for the Werner syndrome, BLM for the Bloom syndrome and RECQL4 for the Rothmund Thomson syndrome. All are responsive of a high cancer risk due to genomic instability. Molecular and cellular mechanisms involved in these diseases of ageing are unknown. Moreover, for all of them, there is not therapeutic or preventive solution.

For understanding the involved mechanisms we would like to model the 3 diseases with hiPS (human induced Pluripotent Stem cells) from somatic cells of patients. The patient recruitment was organized by the Montpellier and Nîmes public hospitals.

The project is to generate a hiPS cell line for the 3 syndromes from fibroblasts and/or blood samples. Then, we could induce differentiation of hiPS to a target cell line of the diseases. Finally we could study the disease development following the genomic instability (karyotype, array-CGH) and the cellular ageing (senescence-associated heterochromatin foci, telomere length).

For each mutated enzyme, we will perform a transcriptional profiling (splice, mRNA quantification) and protein studies (western blot). All results will be compared to wild type cells.

Eligibility Criteria:
Inclusion Criteria:

* Patinet with one of the 3 helicase-associated precoce aging desease

Exclusion Criteria:

* Minor and /or mentally incapable patient
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients.


Eligibility Criteria:
Inclusion criteria:

* Male and females aged 18 to 75
* Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-ME, with or without corticosteroids, as primary immunosuppression

Exclusion criteria:

* Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney.
* Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose).
* Patients with thrombocytopenia (\< 75,000/mm3), with an absolute neutrophil count of \< 1,500/mm3, and/or leukocytopenia (\< 2,500/mm3), and/or hemoglobin \< 6 g/dL at Screening or Baseline.

Other inclusion/exclusion criteria may apply
Variations of Immune Infiltrate and Cell Plasticity Markers in Treated Metastatic Melanoma Patients

COLEMAN is an opened prospective monocentric non-randomized study, initiated by the Hospices Civils de Lyon. Population targeted are patients from 18 years old with stage III or IV metastatic melanoma eligible for a metastatic melanoma treatment administered as part of usual care.

The objective is to study the variations of immune infiltrate and cell plasticity before and under immunotherapy or targeted therapy. Two biopsies are done before and one month after the treatment initiation and one blood sample is done after the treatment initiation.

100 patients will be included and followed during 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥ 18
* Female patients must agree to the use of 2 methods of contraception. For man one method of contraception is needed if if his partner is in childbearing age throughout the study and for at least 5 months after last study treatment administration.
* Patients with metastatic stage III or IV melanoma relapse
* Eligible for a melanoma metastatic treatment indicated and administered as part of usual care
* Patients must be willing and able to undergo cutaneous tumor biopsies (except on the face and folds or lymph node) according to the study protocol
* Patient insured or beneficiary of a health insurance plan
* Patient able to provide informed consent and sign approved consent forms to participate in the study
* Patient accepting the conservation of biological samples and their use for clinical research including genetic research

Exclusion Criteria:

* Hematologic tumours under treatment
* Patients with a documented history of autoimmune pathology
* Ocular melanoma
* Persons placed under the safeguard of justice
* Use of immunosuppressants including corticosteroids 4 weeks before the inclusion
A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma

BRF113710 is a Phase II, single-arm, open-label study to assess the efficacy, safety, and tolerability of GSK2118436 administered twice daily as a single agent in subjects with BRAF mutant metastatic melanoma. Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age
* Must have histologically confirmed cutaneous metastatic melanoma (Stage IV) that is BRAF mutation-positive (V600 E/K) as determined via central testing with a BRAF mutation assay.
* Is treatment naive or has received prior treatment for metastatic melanoma.
* Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
* Women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study treatment.
* Women with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 4 weeks after the last dose of study medication.
* Men with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 16 weeks after the last dose of study medication.
* Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
* Adequate organ function.

Exclusion Criteria:

* Previous treatment with a BRAF or MEK inhibitor.
* Cancer therapy (chemotherapy with delayed toxicity, radiation therapy, immunotherapy, biologic therapy, or major surgery) within the last 3 weeks; chemotherapy regimens without delayed toxicity within the last 2 weeks; or use of any investigational anti-cancer or other drug within 28 days or 5 half-lives, whichever is longer, preceding the first dose of GSK2118436.
* A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.
* History or evidence of brain metastases on MRI or head CT if MRI is not able to be performed.
* History of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
* Certain cardiac abnormalities.
Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatome

The purpose of this research study is to collect data on the technical aspects of Lasparoscopy-assisted ERCP and patient outcomes to help guide future medical care of patients with Roux-en-Y gastric bypass surgery.

Patients would have had a Roux-en-Y gastric bypass in the past that had altered their gastric anatomy. Now they have developed bilary and/or pancreatic problems that require and ERCP. With their altered gastric anatomy a standard ERCP would not be possible. Thus they are scheduled for a Laparoscopy-assisted ERCP.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Altered gastric anatomy
* Scheduled to undergo laparoscopy-assisted ERCP

Exclusion Criteria:

* Any contraindications to performing endoscopy
* Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
* The subject is unable/unwilling to give informed consent
Two Institutes Experience in Laparo-Endoscopic Rendezvous Technique for Gallbladder and Bile Duct Stones

The management of gallbladder stones (lithiasis) concomitant with bile duct stones is controversial. The management of CBD stones has evolved considerably since the advent of laparoscopic surgery. The more frequent approach is a two-stage procedure, with endoscopic sphincterotomy and stone removal from the bile duct followed by laparoscopic cholecystectomy. The laparoscopic-endoscopic rendezvous combines the two techniques in a single-stage operation. So the aim of this study was was to evaluate one-stage LC with intra-operative endoscopic sphincterotomy (IOES) vs two-stage pre-operative endoscopic sphincterotomy (POES) followed by LC for the treatment of cholecystocholedocholithiasis.

This is two center study was carried out on 523 patients and completed in 436 patients with gall bladder stones and with suspected or confirmed CBDS at two gastroenterology center at zagazig first 264 patients at the Gastrointestinal Surgery Unit in the Zagazig University Hospitals and second 172 patients at gastroenterology unite at AL AHRAR hospital from January 2010 till April 2022. A single-step technique combining LC and IO-ERCP was used to treat them. To confirm the presence of CBDS, a laparoscopic intraoperative cholangiography (IOC) was performed. A soft-tipped guidewire was inserted into the duodenum through the cystic duct and papilla. Over the guide-wire, an endoscopic papillotomy was introduced. The stones were retrieved with a retrieval balloon after an IO-ERCP and endoscopic sphincterotomy. The length of the postoperative hospital stay, surgical operating time, surgical success rate, postoperative complications, and residual CBDS were all evaluated. 77 patients excluded either incomplete data or didn't complete both steps within our centers.

Eligibility Criteria:
Inclusion Criteria:

1. patients having stone in the gallbladder and concurrent CBD stone, as determined by MRCP or US.
2. Patients with acute cholecystitis, acute cholangitis, obstructive jaundice, and those with highly suspicious criteria for CBD, stones such as dilated CBD on US examination more than7 mm in diameter without obvious CBD stones, high serum bilirubin level, and or high serum alkaline phosphatase level, were also included in this study.

Exclusion Criteria:

1. Patients with history of hepatobiliary surgery as choledocho-duodenal anastomosis.
2. Patients with previous ERCP attempt.
3. Patients with previous upper abdominal surgery as total or partial gastric resection.
4. Patients with morbid obesity.
5. Patients with uncorrectable coagulopathy.
6. Patients aged below 18 years or above 80 years.
7. Patients within the American Society of Anesthesiology (ASA) class 4 and 5 disease.
8. Patients who refused to give consent or participate in the study.