cyrilzakka/clinical-trials huggingface dataset:
Skin Cancer and Hyperthermia and Radiotherapy

The SAHARA trial assesses wether combining ultrahypofractionated accelerated radiotherapy (RT) with hyperthermia is as effective as standard hypofractionated high-dose radiation in treating non-melanoma skin cancer (NMSC).

The SAHARA Trial is investigating if adding hyperthermia to radiotherapy (RT) can enhance treatment outcomes by making cancer cells more sensitive to radiation, thus requiring lower doses and potentially reducing side effects. The trial compares high-dose RT alone with de-escalated RT plus hyperthermia. The aim is to demonstrate that the combination is non-inferior to standard RT in treating non-melanoma skin cancer (NMSC). The trial is designed for elderly people of 65 years or older.

Eligibility Criteria:
Inclusion Criteria:

* Personally signed and dated written informed consent
* Histologically confirmed invasive non-melanoma skin cancer (NMSC), including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) of any differentiation
* ≥ T2 (TNM Classification 8th Edition)
* Tumor thickness up to 2cm (Maximum Depth invasion and/or exophytic growth, measured on pathology report or imaging)
* Local recurrence allowed, if primary treatment longer ago than 6 months (after primary treatment other than radiotherapy (RT))
* Age ≥ 65 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2, with a life expectancy of more than 6 months
* Presentation at the Swiss Hyperthermia Network (SHN) tumor conference mandatory

Exclusion Criteria:

* Other histology than BCC or SCC
* T1 tumor and/or N+ (according to TNM classification 8th edition)
* Tumors after resection (R1 or R2 as well as adjuvant indication)
* Tumor invasion into critical areas
* Several lesions exceeding the capacity of one treatment/radiation field (multiple lesions within one treatment field are acceptable)
* Previous (one month) or concurrent Chemo- or Immunotherapy
* Patients with connective tissue disorders (e.g. Sclerodermia, Lupus erythematodes)
* Lesions inside or in proximity (within 3cm) previously irradiated area
* Medical immunosuppression
* wIRA-specific exclusion criteria

  * Tattoos in irradiated area
  * Increased photosensitivity (either due to simultaneous treatment with photosensitivity-enhancing medications or conditions such as porphyria)
Surgery Plus Target-reduction Chemoradiotherapy vs Regular Chemoradiotherapy for Newly Diagnosed Resectable Nasopharyngeal Carcinoma

Through a prospective clinical trial, we intend to combine surgery, induction chemotherapy, target-reduction intensity-modulated radiotherapy and concurrent chemotherapy as an experimental treatment for patients with newly diagnosed resectable nasopharyngeal carcinoma to illuminate whether combined surgery could bring patients better local-regional control and lower adverse reactions.


Eligibility Criteria:
Inclusion Criteria:

* Performance Status Score 0-1 points.
* Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and/or cytologically.
* Patients with primary nasopharyngeal lesions evaluated as surgically resectable before chemotherapy, including T1 (tumor limited to nasopharynx), T2 (tumor limited to the surface of parapharyngeal space) and T3 (tumor limited to the bottom wall of sphenoid sinus or pterygoid process). Clinical stage: T1-3N1-3M0, T2-3N0M0 (Stage II-IVA) according to AJCC v8.
* Patients with cervical lymph nodes evaluated as surgically resectable before chemotherapy, including cervical lymph nodes with no invasion (encasement) of the common or ICA, the epidermis, mediastinal structures, prevertebral fascia, or cervical vertebrae.
* Patients with retropharyngeal lymph nodes evaluated as surgically resectable before chemotherapy, including simple RPLNs with intact capsule or RPLNs ≤ 1.5cm with mouth opening range \> 4cm.
* Adequate organ function: WBC ≥ 4×10\^9 /L, NEUT ≥ 2×10\^6 /L, HGB ≥ 9 g/dL, PLT count ≥ 100×10\^9/L, TBIL ≤1.5 ULN (TBIL ≤3 ULN for patients with Gilbert Disease), ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g/dL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL/min.
* Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.

Exclusion Criteria:

* Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.
* Suffering severe cardiopathy or pulmonary dysfunction with cardiac or pulmonary function no more than grade 3.
* Extensive recurrent primary tumour beyond the resectable area such as extensive invasion of the skull base or a distance from the tumour margins to the internal carotid artery of less than 0·5 cm.
* Retropharyngeal lymph node involved or adjacent to primary nasopharyngeal lesions (less than 0·5 cm).
* Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.
* During pregnancy or lactation.
* Other patients that the chief physician considered as illegal for this trial.
Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer

This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.

Patients will be randomized in a 2:1:1 ratio to MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy, or SoC. Patients in all arms will continue therapy until progression. Tumor assessments will be performed on computed tomography scans or magnetic resonance imaging scans, preferably with intravenous (IV) contrast. Efficacy for all patients will be assessed by objective tumor assessments every 6 weeks for the first 24 weeks, then every 8 weeks thereafter until treatment discontinuation due to progression or toxicity. All patients will be followed every 3 months for survival after progression is confirmed.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years at the time of screening
2. Documented evidence of recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx).
3. A fresh tumor biopsy for the purpose of screening or an available archival tumor sample. Tumor lesions used for fresh biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy.
4. No prior systemic chemotherapy for recurrent or metastatic disease
5. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
6. No prior exposure to immune-mediated therapy,

Exclusion Criteria:

1. Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with SCCHN of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland)
2. Tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting
3. Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment
4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis, Crohn's disease\], diverticulitis
A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Participants With Prader-Willi Syndrome

The objective of this study is to assess the long-term safety and tolerability of Cannabidiol Oral Solution (CBD) in participants with Prader-Willi Syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Completed activities up to and including Visit 10 (Study Completion) of INS011-16- 085.
2. Participant and/or parent(s)/caregiver(s) fully comprehend the informed consent form and assent form, understand all study procedures, and can communicate satisfactorily with the investigator and study coordinator, in accordance with applicable laws, regulations, and local requirements.
3. If female, is either not of childbearing potential or practicing medically acceptable methods of birth control.
4. Psychotropic treatment will be permitted if the participant has been on a stable dose during the INS011-16-085 and does not anticipate a dose change during the course of the study.
5. Growth hormone treatment will be permitted if the participant has been on a stable dose during INS01-16-085.
6. Any other treatment including thyroid hormones should be stable prior to entering the INS011-17-115 study.
7. In the opinion of the investigator, the parent(s)/caregiver(s) is (are) willing and able to comply with the study procedures and visit schedules, including venipuncture, and the visit schedules.

Exclusion Criteria:

1. Participant or parent(s)/caregiver(s) have commitments during the study duration that would interfere with attending all study visits.
2. Experienced an anoxic episode related to study drug requiring resuscitation during the previous study.
3. Uncontrolled Type I and Type II Diabetes.
4. Developed an adverse event thought to be related to CBD in the previous study and the investigator determines that continuing treatment with CBD would not be in the best interest of the partient.
5. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or other condition which would jeopardize safety or impact validity of results (per investigator).
6. Currently taking felbamate.
7. Compromised respiratory function or severe respiratory insufficiency.
8. Pregnant or lactating female.
9. In the opinion of the investigator, the participant is unsuitable in any other way to participate in this study.
Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 mg for Post Lobectomy Analgesia

The purpose of the study is to evaluate the amount of total pethidine requirement during the 48 hour postoperative period after receiving spinal morphine 0.2 and 0.3 mg.

Thoracotomy causes severe pain to the patients. Continuous thoracic epidural is a gold standard for postoperative pain. However, it needs skill. There are many alternatives such as spinal morphine, intercostal nerve block, cryoalangesia or interpleural block.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 year and \< 70 year
* Patient ASA physical status I-III.
* Scheduled for thoracotomy with lobectomy.
* Can operate a patient-controlled analgesia (PCA) device.

Exclusion Criteria:

* Known hypersensitivity to morphine or pethidine
* History of bleeding tendency.
* Known case of infection at the back
* Patient refuse for spinal anesthesia
* History of cerebrovascular disease.
* Scheduled for video-assisted thoracoscopic lobectomy.
* Need mechanical ventilatory support during postoperative period
Occludin and Zonulin in Attention-deficit/Hyperactivity Disorder

The association between levels of zonulin and occludin and behavioral/emotional problems in children with ADHD are investigated.

Inclusion criteria for the ADHD group are (a) newly diagnosed ADHD (b) no prior psychotropic treatment for ADHD or any psychiatric disorder (c) age 6-12 years. Exclusion criteria were: (a) history of history of inflammatory/noninflammatory, metabolic, or autoimmune disease (b) any special diet history within the past year (c) use of corticosteroids or regular intake of medication in the last 6 months, (d) body mass index (BMI) \[kg/m2\] \> 30), and (e) cognitive deficits by developmental history.

Eligibility Criteria:
Inclusion Criteria:

* (a) newly diagnosed ADHD
* (b) no prior psychotropic treatment for ADHD or any psychiatric disorder
* (c) age 6-12 years.

Exclusion Criteria:

* (a) history of history of inflammatory/noninflammatory, metabolic, or autoimmune disease
* (b) any special diet history within the past year
* (c) use of corticosteroids or regular intake of medication in the last 6 months,
* (d) body mass index (BMI) \[kg/m2\] \> 30),
* (e) cognitive deficits by developmental history
ANF-Rho in the Treatment of Chronic Neutropenia

A 6 month safety, tolerability, efficacy and pharmacokinetic study with ANF-Rho to treat patients with chronic neutropenia.

Chronic neutropenia patients who are eligible for participation will be screened and enrolled to received open-label ANF-Rho for a period of 6 months. Study participation will be separated into 2 periods, Induction (8 weeks) and Maintenance (16 weeks). Blood samples to measure neutrophil levels and biochemistry labs will be drawn throughout the study to monitor efficacy response and patient safety. Pharmacokinetic samples will be collected during both periods and questionnaires will be completed by the patient and investigator for bone pain, quality of life (QOL) and injection site reaction.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 1 years of age or older
2. Patients with established chronic neutropenia defined as Median Absolute Neutrophil Count (ANC) \< 0.5 x 109/L (both with and without demonstrated genetic lesion) having an indication for treatment, including:

   Independent of hematological parameters, all patients with: Shwachman-Diamond syndrome (SDS), Barth's syndrome or other inherited diseases associated with neutropenia (exclude Glycogen Storage Disease 1b)
3. Patients on granulocyte-colony stimulating factor (GCSF) \& PEG-GCSF treatment are still eligible to participate after a washout period of 7 days, after the stopping of the drug
4. Signed and dated informed written consent/assent by the patient/parent
5. Women of childbearing potential with a negative serum pregnancy test and using a reliable method of contraception during the study period. Male study participants also agreeing to use contraception for the study period.

Exclusion Criteria:

1. Evidence of chromosomal abnormalities, myelodysplasia, hematologic malignancy, aplastic anemia, systemic lupus erythematosus, or rheumatoid arthritis (Felty's syndrome) or if the neutropenia was drug-induced
2. Progressive malignant disease or malignancy history
3. Presence of macrophage activation syndrome before the diagnosis of neutropenia
4. Clinical Significant Abnormal Renal, Cardiac, Hepatic or Blood Coagulation disease.
5. Chronic infection such as hepatitis B virus (HBV), hepatitis C Virus (HCV) or Human immunodeficiency virus( HIV) or history of tuberculosis
6. Association with anemia, thrombocytopenia (low blood platelets) before the diagnosis of neutropenia.
7. Drug abuse, substance abuse, or alcohol abuse
8. Use of any other investigational drug at the time of enrollment, or within 5 half-lives prior to enrollment, whichever is longer
9. Patients unwilling and/or who are not capable of ensuring compliance with the provisions of the study protocol
10. Women who are pregnant or breastfeeding
11. Women of childbearing potential who do not use an approved method of birth control. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) is not acceptable
12. Patients with known DNA loss-of-function mutations in GCSFR and RUNX1 genes
Effects of Resistance Exercise During Pregnancy

Pregnant women at increased risk for back pain were studied during the second trimester and randomized to12-weeks of resistance exercise, education or waitlist. Several outcomes were assessed including physical function, quality of life and mood.

A parallel group trial was completed at a single site. Second trimester women (n=134) were randomly assigned (in blocks of 3) to 12-weeks of wait list, bi-monthly pregnancy education classes or twice weekly low-to-moderate intensity resistance training. Resistance training involved one abdominal exercise with no external load and five exercises with an external load that gradually progressed (leg extension, leg press, arm lat pull, leg curl, and lumbar extension). Several outcomes were assessed including physical function, quality of life and mood.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant and able to complete baseline testing during gestational week 21 to 25 of pregnancy.

Exclusion Criteria:

* Regular resistance exercise training (≥ twice per week during the past month)
* an orthopedic or cardiovascular limitation
* a psychiatric disorder
* or had in the current or a prior pregnancy any of the following:

  * two or more miscarriages
  * premature labor
  * placental previa,
  * poor fetal growth,
  * low pre-pregnancy body weight (BMI \< 17.5)
  * a multiple birth pregnancy
  * pre-eclampsia
  * preterm rupture of membranes
  * uterine growth retardation
  * incompetent cervix/cerclage
  * recurrent vaginal bleeding
  * anemia or
  * diabetes.
A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus

The purpose of this study is to evaluate safety, drug levels and drug effects on cells and organs of the body, after receiving multiple increasing doses of BMS-986326 via intravenous (IV) infusion or subcutaneous (SC) injection, in participants with different forms of lupus.


Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of Discoid Lupus Erythematosus (DLE), Subacute Cutaneous Lupus Erythematosus (SCLE), or Systemic Lupus Erythematosus (SLE).
* Participants with DLE or SCLE must have their diagnosis at least 3 months prior to screening and must be confirmed by biopsy (except if only the facial/head/neck region is affected) and must have some ongoing disease activity (based CLASI-A scoring).
* Participants with SLE must have a diagnosis of SLE at screening based on the 2019 EULAR/ACR Classification for SLE and have mild-moderate disease severity (based on a SLEDAI-2K score).

Exclusion criteria:

* SLE that is considered by the Investigator to be severe.
* Drug-induced CLE and drug-induced SLE.
* Women who are pregnant or breastfeeding.
* Current use of \>10 mg prednisone (or equivalent) per day.

Note: Other protocol-defined inclusion/exclusion criteria apply.
Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma

The objective of this study is to determine the survival status of patients enrolled in study GLI01S (all-case observational study).


Eligibility Criteria:
Inclusion criteria:

* Malignant Glioma, patients enrolled in study GLI01S.

Exclusion criteria:

* Corresponding to contraindication of Gliadel.
* Not applicable to indications of Gliadel.
JUMP Prevalence of Sarcopenia and Chemobrain in Post-cancer Patients

Therapeutic advances in oncology have transformed the prognosis of cancer patients, placing a significant number of them either in a context of recovery or in prolonged remission close to a chronic disease. Thus, the reconquest of a life after cancer becomes possible but raises many challenges for the patient, his entourage, the medical profession and our society. One of the major challenges is the detection and management of treatment side effects for all patients. In addition to the standard organic assessment (glycaemia, creatinine, liver test, blood count), we are mainly interested in muscle deconditioning and cognitive impairment, which are particularly disturbed in these populations. After the evaluation day, patients are referred to the most appropriate structures (Adapted physical activity, sports for health, and rehabilitation at Henry Gabriel Hospital).

JUMP research is part of axis 2 of the 2021-2030 cancer plan: "Limiting sequelae and improving quality of life", through sheets 1 (research) / 6 (access and quality) / 7 (prevention). This leads to the concrete implementation on the territory of adapted care channels in the city: medical structure, physiotherapy, Adapted Physical Activity (APA) structures, associative structures; which makes it possible to develop and strengthen the city-hospital link. Finally, it allows the patient to take ownership and get involved in the project, allowing in the future to make them truly active in they care and to advise and motivate their peers.

This study is non-interventional, it uses research on data that is already collected as part of conventional care, during the JUMP evaluation day.

This study allows the investigators to constitute a cohort of patients to study different parameters related to the disease or to the treatments received.

Our main objective in this study is to describe the muscular and neurocognitive impairment of post-cancer patients evaluated as part of the JUMP program.


Eligibility Criteria:
Inclusion Criteria:

* Age : 18 to 74 years
* localization of the primitive: breast, lung, melanoma, testicle, bladder, kidney, ovary, colon and pancreas, hemopathy
* patient who benefited from the post-cancer assessment day-

Exclusion Criteria:

* Under 18years
* Over 74 years
* Patient who did not received any chemical treatment
* Patient who do not wish to participate
Rapid Detection of Bacterial Resistance by MALDI-TOF MS and Antibiotic Savings

This study aims at determining within a short time (\<3h) the susceptibility to clinical isolates of E. coli to the major antibiotics directly from positive blood cultures.

The resistance to antibiotic is a concern for the great majority of pathogenic bacteria. The proportion of antibiotic-resistant bacteria is particularly high in hospital settings. The accumulation of resistance mechanisms can lead to multidrug resistance, therapeutic impasses and a subsequent higher mortality of infected patients. The use of antibiotics in humans and animals creates a selection pressure that favors the dissemination of antibiotic resistant strains. It's necessary to optimize antibiotic consumption to limit the spread of these bacteria. It requires both the fast bacterial identification and the fast determination of their resistance profile in order to use narrower-spectrum compounds.

Usually antibiotic susceptibility testing usually takes 18-24 hours. Mass Spectrometry type Matrix-Assisted Laser Desorption Ionization Time-Of-Flight (MALDI-TOF MS) has become a valuable tool in clinical laboratories for pathogen identification. Preliminary data showed that susceptible and resistant bacteria can be differentiated within 1 or 2 hours with a new technology called 'MS-ASTRA' based on a lower global peak intensity in the presence of the antibiotic of interest (at a concentration corresponding to the susceptibility breakpoint defined by the EUCAST) than in its absence. The objective of this study is to evaluate the performances of this new MALDI-TOF MS method on a panel of wild-type and resistant clinical isolates.

This study aims to determine the resistance of Escherichia coli isolates to cefotaxime, piperacillin-tazobactam, amoxicillin and to implement the method to positive blood cultures. Minimal Inhibitory Concentrations will be determined the standard agar dilution method.

Results and full analyze are deliverable within 2 years. The data obtained with the MS-ASTRA technique will be compared with the resistance status of the clinical isolates. The shortest incubation time (1 or 2 hours) that gives the more accurate result will be evaluate.The antibiotic savings that the implementation of this new method could have allowed will be evaluate.

Eligibility Criteria:
Inclusion Criteria:

* All patients hospitalized in the hospital of Besançon, with a sepsis with E. coli.

Exclusion Criteria:

* Patients without sepsis with E. coli