cyrilzakka/clinical-trials huggingface dataset:
An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.

This is a multicenter, open-label, Phase 3 study in up to approximately 1400 participants. Eligible participants will receive eplontersen once every 4 weeks for up to 36 months or 6 months after eplontersen is approved and available in the site's country, whichever occurs first. Participants will also receive daily supplemental doses of the recommended daily allowance (RDA) of vitamin A. This study will consist of the following periods: less than or equal to (≤) 10-week screening assessment period, up to 36-month treatment period, and up to 6-month post-treatment evaluation period.

Eligibility Criteria:
Inclusion Criteria:

1. Satisfactory completion of Treatment Period and the End of Treatment Visit of the Index Study (ION-682884-CS2) OR diagnosis of ATTR-CM and satisfactory participation on ISIS 420915- CS101 study as judged by the Investigator and Sponsor.
2. Investigator is willing to treat the participant with open-label eplontersen.
3. Willingness to adhere to vitamin A supplementation per protocol.

Exclusion Criteria:

1. Permanently discontinued study drug administration while participating in the Index Study (ION 682884-CS2) or IST (ISIS 420915-CS101 Study).
2. Have any new condition or worsening of an existing condition that in the opinion of the Investigator or Sponsor would make the participant unsuitable for enrolment, or which could interfere with the participant participating in or completing the study, including the need for treatment with medications disallowed in the Index Study.
Study of BiRd Regimen Combined With BCMA CAR T-cell Therapy in Newly Diagnosed Multiple Myeloma (MM) Patients

The purpose of this study is to evaluate the safety and efficacy of BiRd regimen combined with BCMA CAR T cell therapy in newly diagnosed multiple myeloma patients

This is a phase 3, single arm, multi-center study. The patients will receive BiRd regimen (clarithromycin,lenalidomide, dexamethasone) combined with infusion of autologous BCMA-directed CAR T-cells in newly diagnosed MM patients. The study participation will be 4 years including treatment and follow-up periods.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed MM according to the criteria by International Myeloma Working Group (IMWG)
2. Age 18-75
3. Eastern Cooperative Oncology Group (ECOG) score 0-2
4. BCMA positive as detected with flowcytometry or ELISA.
5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
6. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL

Exclusion Criteria:

1. Patients are pregnant or lactating.
2. Nonsecretory MM.
3. History of previous treatment of MM.
4. Patients with uncontrolled active infection.
5. Patients with active hepatitis B or hepatitis C infection.
6. Patients with HIV infection.
7. Patients with atrial or venous thrombosis or embolism.
8. Patients with myo-infarction or severe arrythmia in the recent 6 months.
9. Other comorbidities that investigators considered not suitable for this study.
Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients

The purpose of this study is to determine whether pegylated interferon therapy is effective to treat acute hepatitis C infection in HIV-coinfected individuals.

Background:HIV-infected individuals are at higher risk of developing a chronic course of hepatitis C after infection. Moreover, chronic hepatitis C is less well treatable in HIV-Coinfected than in hepatitis C monoinfected patients. There is basic research and clinical data on hepatitis C mono-infection supporting high sustained response rates of hepatitis C when treatment is started in the acute phase of infection.

Aim of the study: To determine whether pegylated interferon therapy is effective to treat acute hepatitis C infection in HIV-coinfected individuals.

Methods: Prospective, open-label, historical controlled trial. Eligible subjects are treated over 24 weeks with a pegylated interferon at standard dose. Weight-adjusted ribavirin comedication is recommended for HCV-genotypes 1 and 4. Treatment will be withheld for 12 weeks in order to allow spontaneous resolution in subjects with clinical symptomatic hepatitis C infection.

Eligibility Criteria:
Inclusion Criteria:

* Documented acute hepatitis C infection with detectable HCV-RNA (PCR-assay) and elevated serum alanine transferase (ALT) levels. An acute infection is defined by fulfilling two of the following 3 criteria within the preceding four months:

  1. known or suspected exposure to HCV,
  2. documented seroconversion to positivity for antibodies against HCV,
  3. a serum alanine transferase (ALT) level of more than 350 U/l with a documented normal level during the year before infection.
* Documented HIV-infection
* CD4 cells \> 300 /µl
* Ability to understand and sign a written consent form
* Women of child-bearing age: negative pregnancy test

Exclusion Criteria:

* Autoimmune hepatitis or other autoimmune disease
* Decompensated liver disease
* Decompensated renal disease, i.e. creatinine clearance \< 50 ml/min, according to Cockcroft-Gault
* Acute or chronic hepatitis B infection
* Acute infection with hepatitis A or other hepatotropic viruses
* New AIDS defining event less than 1 month prior to enrolment
* Malignancy other than cutaneous kaposi sarcoma treated with systemic chemo-therapy
* History of severe psychiatric conditions, in particular severe depression
* History of seizures
* History of organ transplantation
* Thyroid disease not medically compensable
* Severe heart disease
* Severe retinopathy
* Known allergy to the study drug or one of the galenic compounds
* Hypersensitivity to interferon a
* Thrombocytes \< 90 G/l, neutrophils \< 1.5 G/l, hemoglobin must not be \< 12g/dl (female) or \< 13 g/dl (male)
* Treatment with corticosteroids less than 3 months prior to enrolment
* Alcohol abuse or use of other recreational drugs
* Older than 65 years of age, younger than 18 years of age
* Pregnancy, breast-feeding
Prevention Bundles for SSIs (PREBUSSI).

Surgical site infections (SSIs) are the most complication after a surgical operation and their incidence reaches 20% worldwide. SSIs have been associated to significant morbidity and mortality, high ICU admission rates, increased length of hospital stay, high readmission rates and raised cost. However, there is no registry for SSIs in Greece so far. In addition, it has been considered that almost half of SSIs could be prevented. Therefore, several prevention strategies have been suggested by international health organizations, such as WHO and NICE, that seem to be effective. The aim of the present study is to investigate the effect of 10 prevention bundles on the rate of SSIs, as well their consequences on several financial parameters of the Greek healthcare system.

* 1st phase (2 months) → SSIs rate among abdominal surgical operations and reporting of patients' demographics (gender, age, comorbidities), type of surgery (upper GI, HPB, colorectal), surgical approach (open, laparoscopic), urgency classification, operation time, cost, pathogen cultures and antibiotic sensitivity test.
* 2ο phase (10 months) → implementation of 10 prevention bundles:

  1. Antibiotic delivery 1-1.5 hours before surgical incision and repeat every 4 hours intraoperatively.
  2. Hair removal with electric hair clippers using single-use bladdes.
  3. Surgical scrub with Povidone Iodine solution 4% (Betadine Surgical Scrub)
  4. Skin preparation with chlorexidine alcohol-based antiseptic solution 2%.
  5. Intraoperative and postoperative (4-6 hours) normothermia (\>36οC) using warmed forced-air blankets.
  6. Perioperative normoglycemia (Glu\<200mg/dl) in diabetic patients.
  7. Single-use drapes and gowns.
  8. Surgical team glove changing by before skin incision closing.
  9. Single-layer surgical incision closure with triclosan plus antimicrobial-coated sutures.
  10. Wound irrigation (skin and subcutaneous fat) with Povidone Iodine solution (Betadine) after abdominal wall closure.
* Implementation check of 10 prevention bundles preoperatively, intraoperatively and postoperatively.
* Clinical assessment on POD 1, 3, 7 and 1 month postoperatively for SSI presence (according to WHO 2018 definition).
* Reporting of patients' demographics (gender, age, comorbidities), type of surgery (upper GI, HPB, colorectal), surgical approach (open, laparoscopic), urgency classification, operation time, length of stay, cost, pathogen cultures and antibiotic sensitivity test.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Signed consent from patient or authorized representative
3. Abdominal surgery
4. Open or laparoscopic operations

Exclusion Criteria:

1. Age \< 18 years old
2. No signed consent from patient or authorized representative
3. Neck, thoracic, anal, lumbar operations
4. No closure of abdominal wall or open abdomen
PPOS Protocol Versus GnRH Anatagonist for Expected Normal Responder Patients Undergoing ART : a Randomized Clinical Trial

The aim of this study is to compare the efficacy and safety of Progestin-Primed Ovarian Stimulation (PPOS) protocol versus the fixed GnRH antagonist protocol in expected normal responder patients undergoing intracytoplasmic sperm injection (ICSI) with frozen-thawed embryo transfer (FET). By evaluating key clinical outcomes, including ovarian response, embryological parameters, and pregnancy rates, this study seeks to determine the relative advantages and limitations of each protocol.

In this prospective, non-inferiority trial, we will compare the efficacy and safety of the GnRH antagonist and PPOS protocols in 328 infertile women undergoing ICSI in Kasr Al-Ainy IVF department, Cairo University, Egypt. Before the trial, investigators were required to provide all information related to the clinical trial, including the possible benefits and risks, other therapeutic choices and the right to withdraw, via a written consent. After being provided with sufficient time to decide whether to participate and the opportunity to ask questions, all participants were required to provide written informed consent before study inclusion.

Eligibility Criteria:
Inclusion Criteria:

* • Women who had history of infertility for ≥1 year.

  * Women whose age \<40 years old by the end of the study.
  * Anti-Mullerian hormone \> 1.2 ng/ml.
  * Antral follicle count ≥ 5.

Exclusion Criteria:

* • Age ≥ 40 years old.

  * Women who are diagnosed as polycystic ovarian syndrome.
  * Women with endometriosis stage 3 or 4.
  * Documented previous IVF/ICSI cycles with no oocytes retrieved.
  * Women with contraindications to controlled ovarian stimulation.
  * Patients who refuse to share in the study.
Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

A novel approach for 5-Fluorouracil delivery based on a solid effervescent formulation is proposed . 5-Fluorouracil is water soluble (\~50mg/ml) and therefore has been used for the development of novel topical formulations including nano and microparticles intended for skin targeting. After hydration 5-Fluorouracil could form a complex, a suspension or even be formulated to generate effervescence. In effervescent technology, gas bubbles occur from the liquid after chemical reaction between alkali salts and organic acids (mainly citric or tartaric. Due to liberation in CO2 gas, the dissolution of drug in water is enhanced. The aim of this study is the development and clinical evaluation of topical 5-florouracil effervescent powder formulation in the treatment of vitiligo.


Eligibility Criteria:
Inclusion Criteria:

* Patients who will be diagnosed as localized stable vitiligo.
* Age older than 10 years
* Stability of lesions for a duration of at least 1 year.
* Patients who didn't receive treatment for vitiligo in the previous 6 weeks before starting the study.
* Patients who agreed to join the study and signed written consent and continued till the end of the follow up period

Exclusion Criteria:

* Patients with vitiligo patches on mucous membrane,
* Patients with Koebner phenomenon,
* Other uncontrolled systemic illnesses
* Patients receiving any systemic or topical treatment for vitiligo
OMEGA-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Peripheral Arterial Disease

The principal aim of the study is to determine the effects n3-PUFA on top of standard therapy on surrogate markers of disease severity and/or prognosis in patients with PAD.

Treatment duration will be 3 months, final follow-up is planned at 6 months after inclusion.

Primary outcome parameter is endothelial function assessed by flow-mediated vasodilation using brachial artery ultrasound.

Secondary outcome measures comprise maximum and pain-free treadmill walking distance, pulse wave velocity, whole blood viscosity, platelet activation and plasma markers of inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Severity of disease: Rutherford category II or III - moderate to severe Stable intermittent claudication
* Ankle Brachial Index\<0.9
* Age ≥18 years
* Adequate PAD therapy according to current AHA guidelines

Exclusion Criteria:

* Current treatment with Omacor or other fish oil products
* Planned vascular intervention
* Known hypersensitivity to the study drug
* Rest pain or ischemic ulcer
* Exercise tolerance limited by factors other than PAD
* Inability to perform treadmill test
* Dual antiplatelet therapy (aspirin and clopidogrel)
* Previous myocardial infarction
* Known liver diseases, except fatty liver
* Known bleeding diathesis
* Women of childbearing potential who do not practice a safe contraception method
* Current participation in another intervention study.
* Previous participation in another study with an intervention within the last 3 months
Evaluation of the Adhesion to the GENEPY Network

In order to best meet the needs of all those affected by the genetic risk of cancer in our region, it is important to identify the factors likely to influence the course leading to the GENEPY surveillance network. The aim of this study is to evaluatie the adhesion to the network of care of people at genetic risk of cancer in Midi-Pyrénées (GENEPY).

This network has been open since November 2015 for people who are genetically predisposed to breast / ovarian cancer. The extension to digestive pathologies (HNPCC syndrome, PAF) is in progress. It concerns not only the persons carrying a mutation also those belonging to a family without identified mutation but whose risk of predisposition is important.

The GENEPY network is based on a collaboration between oncogenetic consultations in the region and professionals practicing in institutions (private, public) and liberal: general practitioners, gynecologists, radiologists, oncologists, gastroenterologists, psychologists ...

It is therefore a multicentric and multidisciplinary network, which aims to promote the local care of people genetically predisposed (or considered at high risk of genetic predisposition), while ensuring a high level of competence, to guarantee an optimal and equitable care on the whole of Midi Pyrenees.

The diagnosis of a new genetic disease in an individual is likely to have implications for other family members who may themselves be at risk of developing the disease and / or passing it on to their children.

The inclusion of subjects in the GENEPY network follows the genealogical study of a case (index) : relatives are identified as potentially at risk. In accordance with the recommendations, but also generally at the wish of the patients, the index case is then asked to inform its relatives and to propose them to go to an oncogenetic consultation of their choice. If these people reside in the Midi Pyrenees Toulouse oncogenetic consultation is open to them. If following this consultation a mutation is identified or that their genetic risk is considered important, they are proposed to join the GENEPY network for their monitoring.

Eligibility Criteria:
Inclusion Criteria:

* people with an identified mutation, predisposing to tumors of the breast / ovary or colon / rectum
* people resident in the Midi-Pyrénées region

Exclusion Criteria:

* people under 18
Ventripoint Single Ventricle Study

This study will validate a coordinate-based 3-dimensional echocardiographic technique for the assessment of cardiac size and function in children and young adults with functional single ventricles.

The accuracy of current echocardiographic techniques for measuring ventricular size and function are limited by geometric assumptions, which are particularly problematic in malformed hearts or functional single ventricles, as well as the inability to visualize the entire heart at one time from a single imaging window, and higher heart rates degrading 3D imaging volume rates. This study will validate a coordinate-based 3-dimensional echocardiographic technique for the assessment of cardiac size and function in children and young adults with functional single ventricles, including a comparison to the gold standard of cardiac MRI.

Eligibility Criteria:
Inclusion Criteria:

* All patients with functional single ventricles will be included, regardless of age or surgical palliation stage, who have had or are having a clinically ordered transthoracic echocardiogram and/or cardiac MRI.

Exclusion Criteria:

* Patients with congenital heart disease other than functional single ventricles, patients with single ventricle physiology (but not single ventricle anatomy) following a biventricular conversion pathway, or patients unable to understand or consent in English will be excluded.
Treatment of Eating Disorders by Physical Activity and Nutrition Counseling

"Eating disorders" includes anorexia nervosa, bulimia nervosa, binge eating and other specified feeding or eating disorder (OSFED). Common to all is the intensively occupation to control food intake, body image and body weight. Most people with this kind of disorder don't reach for professional help, or there may be more than 4 years before they do. Cognitive behavior therapy is the foremost method of treatment of eating disorders, but up to 30-50% of the patients don't respond to this. The investigators find it important to identify science based alternatives of therapy, as this may reduce the health concern, and broaden the choice of therapy methods. A former study by Sundgot-Borgen et al in 2002, found guided physical activity to reduce symptoms of bulimia nervosa just as good as the traditional cognitive therapy.

The primary objective of the project is to see whether the combination of physical exercise and dietary therapy is more effective in treating eating disorders, than cognitive therapy.

Secondly, the investigators want to see whether there are any differences with regard to the individual satisfaction of treatment method, and to associated costs. Interviews with a sufficient number of participants from the PED-t arm to meet data saturation criteria, and all theraphists in the new treatment offer, will give uniqe insight to experiences with the treatment method and the delivery of treatment.

Subjects are recruited through primary doctors, social media and newspapers, and will be included continuously by screening interviews. There will be a randomization into two treatment groups (cognitive behavior, or physical activity and nutrition education) to be followed for 16 weeks. Each week includes one meeting of group therapy (90 minutes) and homework related to treatment, and for 4 weeks midway there will be two therapy meetings pr week (a total of 20 meetings). Post tests are planned at week 17, and at 6, 12, and 24 months after treatment.

Participants reqruited during ongoing treatment groups are placed on a waitlist, serving as controls to the treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* Women,
* BMI 17,5-35,
* Age of 18-40 years,
* DSM-5 criteria of bulimia nervosa,
* DSM-5 criteria of Binge eating disorder
* Living nearby Norwegian School of Sports Sciences, NSSS, in Oslo (Norway)

Exclusion Criteria:

* Age \<18 and \>40 years
* BMI \<17,5 and \>35
* Pregnancy
* Competing/experienced athlete
* Anorexia nervosa
* Currently, or during the past 2 years, in active treatment with cognitive therapy
* Other personality disturbances
* Suicidality
Lung Microbiota Analysis in Critically Ill Patients Admitted to the Intensive Care Unit.

Our study aims to evaluate the relationship between the heterogeneity of pulmonary microbiota and clinical and outcome variables among critically ill patients admitted to the intensive care unit (ICU). In patients undergoing invasive mechanical ventilation, an aliquot of bronchoalveolar lavage (BAL) fluid will be used in the microbiology laboratory for the analysis of respiratory microbiota through next-generation sequencing technologies and validate computational techniques.

Traditionally, microbiological investigations and clinical trials have contributed to the definition of lower airways as a physiologically sterile district, whose microbiological balance is altered when a respiratory infectious process occur. Actually, the introduction of molecular study methods aiming at the identification of pathogens through genomic sequencing questioned the pardigm of "one bug-one disease", according to which we usually tend to consider a bronchial or pulmonary infectious event as due to the pathogenic role of a single exogenous microorganism. In such a contest, there are truly few data dealing with the characterization of respiratory microbiota in human BAL as well as with the major determinants of this phenomenon and the possible impact on clinical and microbiological outcomes. Our study, although it's a pilot one, aims to evaluate these aspects in a larger cohort of critically ill patients, observing the relationship between the heterogeneity of pulmonary microbiota and clinical and outcome variables. In patients undergoing invasive mechanical ventilation, an aliquot of BAL fluid will be used in the microbiology laboratory for the analysis of respiratory microbiota through next-generation sequencing technologies and validate computational techniques. For each enrolled patient, we will register demographic, clinical and laboratory variables. The benefits deriving from this study lay in the possibility of improving the understanding of characteristics of critical patient's pulmonary microbioma and its clinical impact. Such an information meets the increasingly topical need to customize medical interventions, especially in the context of critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* execution of bronchoalveolar lavage sampling, either for clinical indications or in the context of surveillance programs
* acquisition of an informed consent

Exclusion Criteria:

* presence of significant coagulation abnormalities and/or severe respiratory failure
* clearly bloody BAL sample
* small quantity of BAL sample (\<5 ml)