cyrilzakka/clinical-trials huggingface dataset:
A Study of Substitution of 5-FU (Fluorouracil) by Capecitabine in Scheme of Chemo-radiotherapy in Patients With Squamous Cell Carcinoma of the Anal Canal.

The squamous cell carcinoma (SCC) of the anal canal is an uncommon neoplasia which corresponds to 1-5% of intestinal tumors. However the risk of SCC of the anal canal has been growing recently. The standard treatment of anal cancer stage II-III is multimodal and consists of combined chemotherapy (infusional 5-fluorouracil and mitomycin) and radiotherapy. This scheme currently used was proposed in 1974, and since then no other effective treatment has been developed.

The purpose of this study is to determine the efficacy and toxicity of the combination of capecitabine and mitomycin with radiotherapy in patients with carcinoma of the anal canal. For this will be selected 51 patients to be treated with chemo-radiotherapy.

The primary endpoint will be local control rate after 6 months of the end of radiotherapy and chemotherapy, defined by the rate of radiological and clinical neoplasia.


Eligibility Criteria:
Inclusion Criteria:

* Invasive anal canal SCC histologically confirmed, T2-4 N0 M0, T (anyone) N1-3 M0 - according to TNM staging system.
* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
* Adequate medullar function, defined as: Absolute neutrophil count ≥ 1,5×109/L; platelets ≥100×109/L; hemoglobin ≥10g/dl.
* Serum AST (aspartato aminotransferase) and ALT (alanine aminotransferase) \< 3 × ULN (upper limit of normal).
* Serum Creatinine ≤ 1,5 ULN and clearance of creatinine estimated (Cockcroft- Gault) ≥ 50 ml/min.
* Signed written informed consent.

Exclusion Criteria:

* Major surgical procedure within 4 weeks of the beginning of the treatment.
* History of severe systemic or psychiatric disease.
* Previous treatment for anal canal carcinoma or other cancer.
* For female patients, current pregnancy and/or lactation
* Unstable angina or acute myocardial infarction within 6 months.
* Concomitant use of oral anticoagulants
* HIV positive with result of CD4 ≤ 200.
* Previously pelvic radiotherapy.
Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children

Growth hormone (GH) treatment in patients with GH deficiency (GHD) is commonly administered daily, although the pulsatile GH secretion is unlikely to be achieved and this regimen is often not complied. The auxological effect of three injections per week (TIW) regimen is controversial, while the metabolic effects were never evaluated in children. The objective of this study was to evaluate whether two different regimens of weekly injections could lead to similar auxological and metabolic effects in children with GHD.

Thirty-two children with growth hormone (GH) deficiency (25 males, mean age 10.5 ± 2.2 yr) were randomly assigned to receive daily (group A, No 16) or three injections per week (group B, No 16) GH therapy for 12 months.

Auxological parameters, insulin-like growth factor-I (IGF-I), glucose and insulin during an oral glucose tolerance test, glycosylated hemoglobin, lipid profile, the oral disposition index (DIo), the homeostasis model assessment estimate of insulin resistance (Homa-IR), the quantitative insulin sensitivity check index (QUICKI) and the insulin sensitivity index (ISI) were evaluated in the two groups of patients.

Eligibility Criteria:
Inclusion Criteria:

* Growth hormone deficiency clinically and biochemically demonstrated

Exclusion Criteria:

* Children affected by multiple pituitary hormone deficiency or receiving any other kind of hormonal replacement therapy or drug and GHD children with a shorter follow-up
Diclofenac Phonophoresis Versus High Power Pain Threshold Ultrasound on Patients With Neck Pain

the aim of this study is to investigate the effect of diclofenac phonophoresis versus high power pain threshold ultrasound in patients with mechanical non-specific neck pain

Neck pain can be a long-lasting condition, Between half and three quarters of patients with neck pain will experience recurrence within 1-5 years. Costs for the society due to neck pain are consequently high. Neck pain (NP) is one of the common musculoskeletal problems. NP can be caused by the stress over the musculoskeletal system due to postural disorders and may also be associated with other causes such as intervertebral disc herniation, nerve compression, or fracture. Musculoskeletal pain due to trigger points is one of the most prevalent reasons for patients to seek treatment. The aim of physical therapy treatment in patient with myofascial pain syndrome is to reduce the pain and restore normal function. Most physical therapy treatments for MPS are targeted to the deactivation of MTrPs. Physical therapy techniques include manual therapies; such as ischemic compression, spray and stretch, strain and counter strain, muscle energy techniques, trigger point pressure release, transverse friction massage; needling therapies, and other techniques such as thermotherapy, ultrasound therapy , phonophoresis and laser therapy.Due to the semi-solid properties, a special method is needed for transdermal permeation of lidocaine. Therefore, many studies have focused on enhancing the level of transdermal permeation by either changing the physiochemical properties of lidocaine or using physical modalities In particular, there has been considerable interest in transdermal permeation using various methods based on the idea that the amount and depth of transdermal permeation can be increased using various physical modalities. patients with mechanical neck pain will be allocated randomly into three equal groups; group A will receive phonophoresis and traditional therapy, group B will receive high power pain thresholdand traditional therapy and group C will receive traditional therapy

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed as non-specific neck pain with upper trapezius and suboccipital muscles active myofascial trigger points less than 3 months of duration and have these criteria: taut band on palpation, hyper sensible tender spot in the taut band, local twitch response referred pain pattern
2. body mass index from 18 to 25 kg/m2
3. their ages from 18-30

Exclusion Criteria:

1. if they had trigger point injections within the past 6 months
2. history of neck or upper back surgery, trauma or fracture
3. history of a whiplash injury, skin diseases and lesions, any sensory disturbances, any vascular syndromes, neck and back deformities
4. cervical radiculopathy, and diagnosis of fibromyalgia syndrome, skin diseases
Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis

The primary objective is to determine the change in Triglyceride (TG) levels following 12 weeks of repeated Intravenous (IV) doses of evinacumab.


Eligibility Criteria:
Key Inclusion Criteria:

1. Previous documentation in the patient's medical records of a fasting serum TG measurement ≥ 1000 mg/dL (11.3 mmol/L) on more than 1 occasion, and all fasting TG values ≥500 mg/dL (5.6 mmol/L) at screening
2. History of a hospitalization and diagnosis of acute pancreatitis in the past 10 years
3. On stable lipid-modifying diet with or without medications (eg, statins, niacin, omega-3 fatty acids). Lipid-modifying diet and doses of medications should be stable for at least 4 weeks (6 weeks for fibrates, 8 weeks for PCSK9 inhibitors) prior to screening
4. Body mass index (BMI) of 18-40 kg/m2

Key Exclusion Criteria:

1. A hospital or clinic discharge diagnosis of acute pancreatitis within 12 weeks of screening
2. Lipid apheresis or plasma exchange treatment within the last 4 weeks or plans to undergo apheresis or plasma exchange during the time frame of the study
3. History of class 3/4 heart failure at any time in the past, or hospitalization for heart failure, diagnosis of a myocardial infarction, stroke, Transient ischemic attack (TIA), unstable angina, Coronary artery bypass surgery (CABG), Percutaneous coronary intervention (PCI), carotid surgery/stenting within 3 months before the screening visit
4. History of bleeding disorders, esophageal varices, heparin induced thrombocytopenia, or contraindications to receiving heparin (eg, allergic reaction to heparin)
5. Previous treatment with Glybera® in the past 5 years or treatment with lomitapide or mipomersen in the past 6 months
6. Pregnant or breast feeding women

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Quality of Life After Tension Free Transvaginal Sling / Tape Operation With a Titanized Surgical Tape (TiLOOP® Tape)

Validation of a new Quality of Life (QoL) questionnaire in a population of patient gaining a TiLOOP® TAPE surgical mesh for stabilization of the urethra.

The prevalence of urinary incontinence in the adult female population has been estimated between 10% and 40%. Several treatment alternatives have been suggested until now. Nevertheless, the ideal treatment has not been identified yet. On the one hand this is related to the low amount of valid scientific information regarding different treatment methods. On the other hand the impact of patients' quality of life, which plays a major role, has not been fully considered. To date, there is no established Questionnaire on Quality of Life that provides physicians an assistance to obtain information on the subjective effects caused by stress urinary incontinence.

In the present study the patients' Quality of Life will be assessed by use of two questionnaires, that is a new one and an already validated questionnaire. The study population consists of patients who already received an implantation of a sub-urethral surgical mesh (TiLOOP® Tape), of symptomatic patients before an operation, and of a group of non-symptomatic women. Subjects will be asked in a single visit only to fill in both questionnaires.

Furthermore the safety and effectiveness of the TiLOOP® Tape mesh will be evaluated in the study arm of treated patients.

Study has been terminated after major recruitment failure (only 21 instead of 240 patients has been included).

Eligibility Criteria:
Inclusion Criteria:

* Depending on study arm:
* Women with a TiLOOP® Tape implant, Implanted between 2007 and 2009 at the study center - OR -
* Woman with a planned Tape implantation at the study center - OR -
* Woman with no disease related to incontinence
* Subject is able to understand the nature, relevance and significance of the clinical trial
* Subject has given informed consent

Exclusion Criteria:

* Subject revoked consent
* Lack of subject's compliance regarding data collection or examination in the scope of the trial (Non-Compliance)
* Subject institutionalized by court or official order (MPG §20.3)
* Subject participates in another clinical investigation
Investigation of Pancreaticoduodenectomy

The investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.

For patients with malignant or benign disease of the pancreatic head and periampullary region, pancreaticoduodenectomy is the only potential approach to radical cure. However, pancreaticoduodenectomy is consider as one of the most complex operations associated with a high rate of postoperative complications such as pancreatic fistula, delayed gastric emptying, hemorrhage, abscess, and sepsis. These complications increase the costs associated with pancreaticoduodenectomy. Numerous interventions and techniques have been introduced to decrease the morbidity. But there is little evidence for the superiority of one anastomotic technique over the others. Therefore, investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.

Eligibility Criteria:
Inclusion Criteria:

Patients who had underwent pancreaticoduodenectomy between 2008 to 2018.

Exclusion Criteria:

None
Investigation of Thenar Muscles Morphometric Parameters in Patients With TMC OA

In this study, investigators aimed to investigate the morphometric parameters tenar muscles and joint configuration in patients with trapeziometacarpal osteoarthritis (TMC OA) osteoarthritis stages, thenar muscle parameters, radial subluxation rate, functional level and hand dexterity.

Patients diagnosed with trapeziometacarpal osteoarthritis and healthy subjects will be included in the study. Thickness and cross-sectional area measurements of the thenar muscles of the patient and healthy volunteers will be performed by using Shimadzu SDU 1200-Pro ultrasound system with an 8-10 MHz linear probe. To improve the image quality and to avoid muscle compression, water immersion ultrasonography will be preferred and the hands will be positioned in a water-filled plastic container. The thenar muscles will be imaged in hands of each subject.

In this study, poster-anterior radiographic imaging will be performed. The osteoarthritis stage will be determined on the radiographic image. Three different measurements will be performed on radiography: radial subluxation of the first metacarpal base (RS), articular width (AW) of the first metacarpal, and the distance between the ulnar articular facet of the trapezium and the ulnar edge of the metacarpal (U). RS / AW ratio will be calculated.

Because TMC OA caused pain and affect performance, especially during grip activities in the osteoarthritis and control groups will be tested.

Grip strength will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients with trapeziometacarpal osteoarthritis who were between 35 and 75 years

Exclusion Criteria:

* Patient with De'quervain tenosynovitis, trigger finger, entrapment neuropathy and who had undergone hand surgery were excluded.
Covid-19 Vaccine Response in Heart Transplant Recipients

Clinical studies indicate a decrease in vaccine efficacy in certain immunocompromised populations (kidney transplant recipients, patients undergoing chemotherapy). It was recently reported that only 18% to 49% of heart transplant recipients developed antibodies after 2 doses of BNT162b2 vaccine. Following the published results, it is currently recommended to use 3 doses in organ transplant recipients who have not contracted COVID-19 and 2 doses in those who have been infected. The effectiveness of this strategy is not yet sufficiently evaluated in heart transplant recipients. Moreover, the factors associated with the humoral and cellular response, the kinetics and durability of the humoral response, the occurrence of the cellular immune response and the tolerance of the vaccine are not well known in this population.

To provide answers to these different questions, we set ourselves the objective of evaluating the humoral and cellular response to messenger RNA (mRNA) vaccines in heart transplant recipients followed at Bichat Hospital.

In order to evaluate the effectiveness and safety of currently adopted vaccination strategies in heart transplant recipients we intend to study the humoral and cellular responses to SARS-CoV-2 mRNA vaccines in heart transplant recipients followed at Bichat Hospital.

All heart transplant recipients followed at Bichat Hospital will be invited to participate in this research.

The vaccination schedule was 3 doses for the seronegative patients without documented infection, and 2 doses for patients who were seropositive or had a positive Reverse Transcriptase - Polymerase Chain Reaction (RT-PCR) test for SARS-CoV-2. Most patients were vaccinated at Bichat Hospital. Their vaccination schedule will be recovered. Some patients refused vaccination.

Since the beginning of 2020, the transplant patients have benefited from systematic serological tests and RT-PCR testing of nasopharyngeal swabs in the event of symptoms suggestive of SARS-CoV-2 infection as part of routine care. The results of these tests will be retrieved from medical records retrospectively in order to investigate the kinetics and durability of the humoral response. Demographic and clinical data will be collected to determine the factors associated with vaccine response.

In addition, a whole blood sample will be drawn at inclusion in order to evaluate cellular response. The patients will be also asked to answer a questionnaire regarding vaccine tolerance.

The effectiveness of vaccination program will be assessed after 6-month follow-up based on the occurrence of SARS-CoV-2 infection, unscheduled medical consultation or hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Heart transplant patients followed at Bichat Hospital
* Aged 18 or older
* Informed and having expressed their non-objection to participation in this research
* Able to give their agreement

Exclusion Criteria:

* Minors
* Heart transplant recipients who have expressed their opposition to their participation
* Legally protected adult
* Persons under the State Medical Assistance (AME)
AMH, Glucose Intolerance and Metabolic Syndrome in PCOS

Association between serum anti-Mullerian hormone (AMH) level and prevalence of glucose intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS)

* To study the association between serum anti-Mullerian hormone (AMH) level and glucose intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS).
* Glucose intolerance is detected by 2-hours 75 gram oral glucose tolerance test (OGTT).
* Metabolic syndrome is diagnosed by using the Harmonized criteria; the presence of any 3 of 5 following risk factors constitutes a diagnosis of metabolic syndrome.

  1. Elevated waist circumference (\> 80 cm in Asian women)
  2. Elevated triglycerides (\> 150 mg/dL)
  3. Reduced HDL-cholesterol (\< 50 mg/dL)
  4. Elevated blood pressure )systolic \> 130 and/or diastolic \> 85 mmHg)
  5. Elevated fasting glucose ( \> 100 mg/dL)
* Percentage of glucose intolerance and metabolic syndrome in PCOS women as well was any differences in parameters between PCOS patients with and without glucose intolerance and metabolic syndrome will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* PCOS diagnosed by Rotterdam criteria 2003

Exclusion Criteria:

* Pregnancy
* Previous any hormonal uses in the last 3 months
* Previous hypoglycemic drugs or insulin-sensitising agents use in the last 3 months
* Previous chemotherapy, ovarian surgery, pelvic irradiation
* Menopause
Minimal-Dose Resistance Training for Improving sIgA and Cortisol

Whereas the role of endurance training on immune function has been widely studied, little is known about the role of resistance training (RT). In this cross-over randomized controlled study, it will be analysed the effects of three RT protocols which only differs in volume in improving secretory immunoglobulin A (sIgA) and cortisol in saliva among young, health and sedentary people


Eligibility Criteria:
Inclusion Criteria:

* 18-30 years
* Sedentary

Exclusion Criteria:

* to have had COVID-19 during the last 3 months
* to have been vaccinated against COVID-19 during the last 3 months
* physical limitations or health problems
Fampridine Pregnancy Exposure Registry

This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with multiple sclerosis who have been exposed to prolonged-release fampridine since the first day of their last menstrual period prior to conception or at any time during pregnancy.

There are no mandatory physician visits. The registry will collect pregnancy outcome data from the participants health care provider during the prenatal follow up (6-7 months gestation), pregnancy outcome (4 weeks after estimated delivery date) and finally the pediatric follow up (at 4 weeks and 12 weeks post birth).

Eligibility Criteria:
Key Inclusion Criteria:

* Documentation that the patient was exposed to prolonged-release fampridine since the first day of her last menstrual period (LMP) prior to conception or at any time during pregnancy. (If exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure.)
* The outcome of the pregnancy must not be known at the time of report.

Key Exclusion Criteria:

* None

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Relation Between Substance Use and Pain, in Patients Suffering or Surviving From Cancer and Followed in France

Pain is one of the most prevalent symptoms during and after cancer. Pain can be the consequence of several situations (disease progression, surgery, and anticancer drugs). However, pain can frequently be associated with a substance use disorder (alcohol, tobacco, drugs, and illicit products such as cannabis). The relationship between substance use and pain is known to be complex and interdependent, i.e. pain can reinforce substance use and substance use can promote pain. However, few data in the literature are available on the use of psychoactive substances in relation to pain in the context of cancer (cancer patients and cancer survivors). Moreover, the scientific literature agrees on the fact that these elements are little studied and underestimated in the clinic.

The investigators hypothesize that, in cancer patients or cancer survivors, the prevalence of the use of psychoactive substances would be higher in the presence of pain, and would be associated with its intensity and its impact on the quality Health-Related Living (HRQoL).

The main objective of this study will be to compare, in an adult population of patients suffering from cancer or having had cancer, the prevalence of the consumption of psychoactive substances in painful patients compared to non-painful patients.

Patients will answer to an online questionnaire thanks to associations of cancer patients and social networks, in order to explore their substance use and pain status.

Eligibility Criteria:
Inclusion Criteria:

- Adult patient, male or female, declaring himself as suffering or having suffered from cancer and recruited as such via appropriate communication systems (patient associations, etc.)

Exclusion Criteria:

* Difficulty to understand French language
* Residence outside France (will be verified by the information from the department at the start of the questionnaire)
* Patient close relative
* Protected adults
18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia

This purpose of this study is to determine the ability of an 18F-fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET (Positron Emission Tomography) scan to detect a focal lesion of hyperinsulinism and determine the location in patients with congenital hyperinsulinism, Beckwith Wiedemann Syndrome and suspected insulinoma. Safety data will be collected.

Patients with hyperinsulinemic hypoglycemia are at risk for neurological damage due to hypoglycemia. Early surgical intervention can be preventative. F-DOPA PET may be able to detect of a focal lesion prior to surgical intervention and be used during surgical planning to guide the surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of any age with hyperinsulinemic hypoglycemia, diagnosed by a fasting test and/or response to glucagon stimulation.
* Subjects who are eligible for pancreatic surgery regardless of prior pancreatic surgery

Exclusion Criteria:

* Pregnant or lactating females
* Any other major illness or condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in this study
* Subjects who are not a candidate for pancreatic surgery