cyrilzakka/clinical-trials huggingface dataset:
Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)

Hypofractionated intraoperative boost (HIOB) is defined as hypofractionated WBRT (40.5 Gy in 2.7 Gy per fraction) preceded by an intraoperative boost to the tumor bed (10 Gy IOERT). The HIOB study concept will test whether such a combined schedule is superior or iso-effective standard RT in terms of local control and cosmetic outcome.

The purpose of this research study is to find out the effects (good and bad) of adding a dose of radiation to the area of the cancer during surgery to whole breast radiation therapy (WBRT) after surgery. IOERT is the application of electron radiation directly to the residual tumor or tumor bed during cancer surgery. WBRT is a type of radiation therapy used to treat patients who have cancer in the breast covering the entire breast tissue. Both immediate and long-term effects will be measured.

For patients with certain types of breast cancer, one standard treatment is removal of the area of cancer and a small amount of normal tissue around it followed by breast radiation. The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks of WBRT followed by 5-8 daily radiation treatments at the site where the lump was removed called a "boost". During this study, the single dose of electron irradiation (IOERT) given at the surgical site during the operation will replace the usual 5-8 days of localized radiation and the whole breast radiation will last 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Histological proven invasive breast carcinoma (ductal and lobular)
* Age \> 40 years
* Karnofsky performance status \>70%
* Single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of 4 cm (invasive foci)
* Nodal Status: NO-1
* Clear surgical margins: R0; min 2mm. Re-excision after IOERT is permitted but not required to achieve (-) margin.
* All grades G1 - G3
* Any hormonal receptor and Her-2 status
* Informed consent

Exclusion Criteria:

* In-situ Carcinoma without invasive component or multifocal disease \> 4 cm
* Tumor stage: T3 or 4
* Nodal Status \> N1 pathologically
* Surgical margins \< 2mm
* Multicentricity
* Previous radiotherapy to the involved breast
* Karnofsky Index \< 70%
* Mixed connective tissue diseases e.g. rheumatoid polyarthritis, thromboangitis obliterans, systemic lupus.
* Distant metastases
* Unable to provide written consent
Input of the Use of Indometacin in Gitelman Syndrome as Compared to Potassium Sparing Diuretics

Gitelman syndrome is a rare renal disease where the kidneys are unable to normally retain some salts (sodium, potassium and magnesium). Main consequences of these renal leaks of salts are a tendency toward low blood pressure, hypokalemia and hypomagnesemia both contributing to cardiac and muscles symptoms.

Patients with received in random order 75mg/day indometacin (Chronoindocid®), 10-20 mg/day amiloride and 50-150 mg /day eplerenone (Inspra ®). The three 6 weeks-periods of treatment will be followed by six weeks washout period. 3-6 weeks before the first period of treatment, a supplementation with potassium and magnesium will be orally given, and maintained at the same dose throughout the study and stoped 6 weeks after the end of the third period of treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients 18-60 yrs old, both sex, with genetically proven Gitelman's syndrome, under birth pill control for woman.

Exclusion Criteria:

* counter-indication to treatment under study
* Other diuretic or NAIS treatments than amiloride, spironolactone, or indometacin
Myofunctionnal Therapy on Nasal Breathing and Orthodontic Corrections Stability

The current research project aims to study the efficacy of myofunctional therapy and its orthodontic long-term outcomes.

The current research project aims to study the efficacy of myofunctional therapy and its orthodontic long-term outcomes, such as: 1) Is treating a low tongue position and lip closure at rest sufficient for orthodontic short and long-term outcomes? 2) Does treating atypical swallowing along with an incorrect tongue position help achieve and maintain higher outcomes of the myofucntional and orthodontic treatments?

Eligibility Criteria:
Inclusion Criteria:

* Between 6 and 14 years old
* Atypical or immature swallowing pattern and lower position of the tongue at rest
* Be an orthodontic patient treated at the Faculty of Dentistry, Université de Montreal
* Speak and understand French without assistance
* Be in good health (without neurological or psychiatric syndrome)
* Agree to participate and sign the consent form research

Exclusion Criteria:

* Non compliance to clinical visits (eg too many missed visits)
* Patients who had previous orthodontic treatments
* Syndrome or known systemic disease (chronic cardiopulmonary or neuromuscular disease, dysmorphia, major craniofacial abnormalities)
Didgeridoo Treatment to Improve Pharyngeal Compliance in Obstructive Sleep Apnea-hypopnea Syndrome in Children

The therapeutic management of Obstructive Sleep Apnoea Syndrome in children remains a debated subject, only otorhinolaryngology surgery (adenoidectomy) has been studied on a large scale. Pathophysiologically, increased pharyngeal collapsibility is a major endotype of the disease and the investigators have shown that this surgery can improve pharyngeal compliance. The development of approaches to treat pharyngeal hypotonia by maxillofacial rehabilitation supports the treatment of this endotype. A study in adults showed a benefit from playing the didgeridoo, a wind instrument, for 3 months, without pathophysiological explanation. The investigators hypothesise that playing this instrument improves pharyngeal compliance (re-education effect) in a similar way to the effect observed after otorhinolaryngology surgery.

This proof-of-concept study aims to demonstrate the effect of didgeridoo in children without syndromic pathology with a formal otorhinolaryngology surgical indication resulting from tonsillar hypertrophy (Brodsky grades III and IV) and symptomatology suggestive of Obstructive Sleep Apnoea Syndrome (Pediatric Sleep Questionnaire score ≥ 0.33). The investigators will take advantage of the long delay in performing the adenoidectomy (\~6 months) in their university hospital to evaluate, before the scheduled surgery, the effect of the didgeridoo used for three months.

Randomised controlled trial, with minimisation criteria, single blind, bicentric.

The subjects will be divided into 2 groups, according to the strategy of care before the date of the scheduled surgery: 1. Abstention (routine care) 2. Didgeridoo rehabilitation.

The primary objective is to improve pharyngeal compliance measured non-invasively by acoustic pharyngometry in the didgeridoo arm compared to a no treatment arm.

The secondary objectives are to demonstrate the effect of the didgeridoo on clinical signs associated with Obstructive Sleep Apnoea Syndrome and on an indirect index of apnea-hypopnea during sleep.

Eligibility Criteria:
Inclusion Criteria:

* Clear tonsillar hypertrophy (Brodsky grade III to IV), justifying surgery
* Pediatric Sleep Questionnaire ≥ 0.33
* Discontinuation of any prescribed medication for Obstructive Sleep Apnea Syndrome (anti-histamine and montelukast)
* Access to the Didgeridoo course
* Consent of the holders of parental authority and agreement of the child

Exclusion Criteria:

* Syndromic pathology
* Lack of affiliation to a social security scheme
* Holders of parental authority under guardianship or curatorship
Comparison of the Efficacy of Calcium-cholecalciferol Foodstuffs and Calcium-cholecalciferol Supplement

This study is conducted in two phases. At the first phase, the prevalence of vitamin D insufficiency in primary school-children in Tehran is determined during the cold seasons of 2008. Then, the efficacy of calcium-vitamin D-fortified milk, -orange juice and supplement is compared in six selected primary schools.

At the first step, serum 25-(OH)D, PTH(parathyroid hormone), osteocalcin, bone alkaline phosphatase, calcium, phosphorous, and magnesium is evaluated. Anthropometric and dietary intake data is also collected. In the second phase, we have 6 experimental groups: (1) plain milk; (2) calcium-vitamin D-fortified milk (containing 500 mg Ca and 100 IU vitamin D/200 mL package); (3) plain orange juice; (4) fortified orange juice containing equal amounts of calcium and vitamin D as fortified milk; (5) calcium-vitamin D supplement (500 mg calcium and 200 IU vitamin D); and (6) placebo. Each group consists of 40-60 children (9-11 years) from both sexes. All above-mentioned biochemical, anthropometric and dietary intake data is collected both in the beginning and in the end of interventional period.

Eligibility Criteria:
Inclusion Criteria:

* Age: 9-11 years
* Being healthy (no apparent clinical disease)
* Informed consent signed by child's parent(s)

Exclusion Criteria:

* Subjects receiving vitamin D, calcium or omega-3 supplement
* Unwillingness to continue the study
* Subjects with type 1 diabetes, allergy, kidney disorders
Plastic Surgery Training in Europe

Survey study to evaluate plastic surgery training in European countries.

National delegates of 30 European countries - the 27 member countries of the European Union (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Spain and Sweden) and Norway, Switzerland and the United Kingdom were invited to complete a questionnaire on plastic surgery training.

Eligibility Criteria:
Inclusion Criteria:

* Countries of the European Union (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Spain and Sweden) and Norway, Switzerland and the United Kingdom
* Countries must organise plastic surgery training

Exclusion Criteria:

* Countries other than member states of the European Union, Norway, Switzerland and United Kingdom
* Countries that do not provide plastic surgery training
Patient-individualized Peptide Vaccination Based on Tumor-specific Mutations in Children and Young Adults With Primary/Relapsed ALL

The aim of this clinical study is to evaluate the feasibility and safety of an individualized peptide vaccination approach in patients with acute lymphoblastic leukemia (ALL). For this purpose, tumor-specific mutations are analyzed by comparative exome sequencing of tumor and healthy reference tissue. Expression of variants is further validated by RNA sequencing. In a second step, HLA-binding (human leukocyte antigen-binding) peptides derived from mutated protein sequences are selected for vaccination. The peptides are administered as a vaccination cocktail with adjuvant GM-CSF and Imiquimod over a course of 9 months and a total of 16 vaccinations. Primary objective is the de novo induction of a specific T cell response without unacceptable toxicity and acute GvHD (graft versus host disease).


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients and young adults with ALL (T, B, pro-B, pre-B or c-ALL) ≥CR3 or with ≥1st relapse after stem cell transplantation (SCT); or patients in ≤CR2 who have received SCT without having reached a sufficient molecular remission prior to, or after SCT (defined as MRD ≥10\^-4); or patients with initially refractory disease to standard treatment who could proceed to stem cell transplantation with alternative treatment options.
* Hematological remission has to be reached (\<5% blasts in bone marrow or detectable minimal residual disease (MRD) ≤5x10\^-2) after salvage chemotherapy and/or subsequent SCT.

Exclusion Criteria:

* Frank relapse (\>5% leukemic blasts).
* Ejection fraction \<25%; Creatinine-clearance \<40ml/min; Bilirubin \>4mg/dl, Transaminases \>400 units/ml; severe infection (HIV, Hepatitis), acute GvHD III-IV or chronic GvHD.
* Significant psychiatric disabilities, uncontrolled seizure disorders or severe peripheral neuropathy/ leukoencephalopathy.
* Signs of autoimmune disease (i.e. idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia).
* Need for immunosuppressive drugs.
* No tumor material available for exome sequencing.
BASE HSP110 : A New Therapeutic Target and a New Marker for Prognosis of Type MSI Colorectal Cancer

We collect prospectively and retrospectively, patients' demographic, pathological, surgical, therapeutic and prognosis informations in a database. After patient's consent to collect tumoural samples of their colorectal cancer after resection.

We will then be able to evaluate the impact of HSP110, a chaperon protein, on their prognosis. Other proteins (to be determined) will also be study, after.

To investigate the importance of HSP110DE9 as a prognostic marker for colorectal cancer, we will analyze genotyping fluorescence quantitative RT-PCR and / or immunomarquage the presence of this mutant in a large cohort of patients (more than 2000 patients had or having a colorectal cancer). All patients have been or will be made in general and digestive surgery department at Saint-Antoine hospital. Tumor fragments samples were or will be made on their tumor and keep it in the tumor bank of the Saint-Antoine hospital. All patients reported their no objection to the use of these tumor fragments for research purposes. A database will be built and correlated with the tumor fragments. This project is intended that the constitution of a clinical database including prognostic so that we make discoveries on HSP110DE9 or other molecular biology to discover markers can be correlated with clinical data. In the absence of other studies on the subject, with no real knowledge of the prognostic impact of this mutant, we cannot provide an effective computation. We therefore propose to make a database of 2000 patients retrospectively and prospectively to obtain statistical results valid and powerful.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing curative colorectal cancer in general and digestive surgery department at Saint-Antoine hospital.
* Patients reporting their non-opposition to the use of tissue samples taken from their specimen for research purposes.

Exclusion Criteria:

* Patients who did not report their non-opposition to the use of tissue samples taken from their specimen for research purposes.
Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes

This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of biphasic insulin aspart (BIAsp) 50 (NN-X14Mix50) compared with biphasic human insulin (BHI) 50 in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes
* Subjects with insulin treated for at least 24 weeks
* HbA1c maximum 11.0%
* Body mass index (BMI) below 30.0 kg/m\^2
* Patients who have the skill of self-injection of insulin, and are able and willing to perform self-monitoring blood glucose (SMBG) and are able to take measures against hypoglycaemic episodes

Exclusion Criteria:

* Recurrent severe hypoglycaemia
* Subjects with proliferative retinopathy or preproliferative retinopathy diagnosed within the last 12 weeks, or receiving photocoagulation therapy within the last one year
* Impaired hepatic function
* Impaired renal function
* Cardiac diseases
* Uncontrolled hypertension
* Subjects with history of severe allergic or severe hypersensitive reactions
* Total daily insulin dose at least 100 IU
* Treatment with oral hypoglycaemic agentsvwithin the last 4 weeks
An AI Platform Integrating Imaging Data and Models, Supporting Precision Care Through Prostate Cancer's Continuum

In Europe, prostate cancer (PCa) is the second most frequent type of cancer in men and the third most lethal. Current clinical practices, often leading to overdiagnosis and overtreatment of indolent tumors, suffer from lack of precision calling for advanced AI models to go beyond SoA by deciphering non-intuitive, high-level medical image patterns and increase performance in discriminating indolent from aggressive disease, early predicting recurrence and detecting metastases or predicting effectiveness of therapies. To date efforts are fragmented, based on single-institution, size-limited and vendorspecific datasets while available PCa public datasets (e.g. US TCIA) are only few hundred cases making model generalizability impossible.

The ProCAncer-I project brings together 20 partners, including PCa centers of reference, world leaders in AI and innovative SMEs, with recognized expertise in their respective domains, with the objective to design, develop and sustain a cloud based, secure European Image Infrastructure with tools and services for data handling. The platform hosts the largest collection of PCa multi-parametric (mp)MRI, anonymized image data worldwide (\>17,000 cases), based on data donorship, in line with EU legislation (GDPR). Robust AI models are developed, based on novel ensemble learning methodologies, leading to vendor-specific and -neutral AI models for addressing 8 PCa clinical scenarios.

To accelerate clinical translation of PCa AI models, we focus on improving the trust of the solutions with respect to fairness, safety, explainability and reproducibility. Metrics to monitor model performance and a causal explainability functionality are developed to further increase clinical trust and inform on possible failures and errors. A roadmap for AI models certification is defined, interacting with regulatory authorities, thus contributing to a European regulatory roadmap for validating the effectiveness of AI-based models for clinical decision making.


Eligibility Criteria:
Inclusion Criteria:

1. histological confirmed PCa or suspicion of PCa (abnormal PSA values and/or positive DRE);
2. magnetic resonance imaging examination, including at least a high-resolution axial T2-weighted imaging and axila diffusion-weighted imaging (dynamic contrast-enhanced imaging is recommended, but not mandatory);
3. age ≥ 18 years at the time of diagnosis
4. signed written informed consent form (only for prospective enrollement).
Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid

Purpose: The study aimed to determine whether intravenous administration of tanexamic acid (TXA) before shoulder arthroscopic rotator cuff repair surgery can improve arthroscopy visual clarity. Methods: This is a prospective, double-blinded, randomized and placebo-controlled study. From May 2016 to April 2018, patients requiring arthroscopic rotator cuff repair were enrolled and randomly assigned to either the TXA group that received 1000mg tranexamic acid intravenously 10 minutes before surgery or the placebo group that received the same volume of plain saline. Patients with pre-existing liver/renal disease, coagulopathy, or concurrent use of anti-coagulation medications were excluded. The visual clarity was rated by a numeric rating scale from grade

1(poor) to grade 3(clear) every 15 minutes throughout the surgery. Secondary outcomes included estimated perioperative blood loss, operative time, degree of shoulder swelling, postoperative subjective pain score, inpatient duration and associated comorbidities were recorded. Both parametric and nonparametric methods were used for statistical analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with rotator cuff tear and failure of conservative treatment for more than 3 months. The tear size was measured by MRI and must be repairable.

Exclusion Criteria:

* Acute traumatic rotator cuff tear.
* History of coagulopathy
* Under anticoagulation therapy before surgery
* Abnormal coagulation profile (prothrombin time or activated partial thromboplastin time) before surgery
* Renal or liver disorder
* Uncontrolled hypertension (baseline systolic pressure \&gt;180 mmHg)
* Allergy to local anesthetic agent or TXA.
Skeletal Health of Klinefelter Patients

This study compared the bone health of KS patients who were actively monitored in our clinic by dual-energy X-ray absorptiometry (DXA) with that of a control group of healthy volunteers.

Klinefelter syndrome (KS) is the most common chromosome number abnormality of men, occurring in 1/500 to 1/1000 live births . It was first described in 1942 as an endocrine disorder characterised by small, hard testicles androgen deficiency, gynaecomastia and increased follicle stimulating hormone (FSH). Osteoporosis is a progressive bone remodelling disorder in which bone loss exceeds bone formation. The resulting micro-architectural defects and bone fragility are associated with increased fracture risk and mortality. In KS, testosterone deficiency is associated with decreased bone mass and low bone mineral density (BMD) , and a positive correlation of total serum testosterone and BMD has been reported . There are some exceptions ; however, most studies have reported that KS increases the risk of osteopenia and osteoporosis compared with age-matched control groups.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of klinefelter

Exclusion Criteria:

* klinefelter subjects with a history of hip or waist surgery or trauma
* for control group with known bone disease, unknown fertility hypogonadism findings on physical examination (e.g. low testicular volume or abnormal body hair), known hypogonadism, previous androgen replacement therapy any drug therapy affecting bone metabolism
Does Statin Initiation Undermine Dietary Behavior?

The purpose of this research is to improve our understanding of the effects that taking cholesterol reducing pills have on dietary behavior as well as other health related behaviors

This study explores the impact of initiating statin therapy on subsequent dietary as well as other lifestyle beliefs, attitudes and behaviors.

Specific aims:

1. To test whether the initiation of statin therapy increases dietary saturated fat intake among statin naive patients.
2. To determine what role attitudes, beliefs, expectations, motivation, intention and self-efficacy regarding drug or diet therapy may play in observed changes in dietary behavior after starting statin therapy.

Eligibility Criteria:
Inclusion Criteria:

All English-speaking adults who have recently (within 1 week)received their first prescription for a statin will be eligible.

Exclusion Criteria:

Will include a history of any of the following:

1. Prior CVD (myocardial infarction, angina, angioplasty, stroke, CABG. or arterial bypass surgery)
2. Diabetes patients
3. Psychiatric patients
4. AIDS patients
5. Substance abuse patients
6. Prior cholesterol lowering medication use
7. Inability to complete the interviews