cyrilzakka/clinical-trials huggingface dataset:
Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1

Recent scientific advances have shown the important role of immune system against cancer. Today, many immunological biotherapy like anti-PD1/PDL-1 are available in cancer treatment and generate durable clinical responses in some patients. The development of tools for monitoring anti-tumor immune responses dynamically is a major challenge to predict the effectiveness of immunotherapies anti-PD-1 and anti-PDL-1.

Thus, the objective of our study is to analyse the interest of the monitoring of anti-telomerase T helper 1 (TH1) responses in predicting the efficacy of immunotherapy, using an immunoassay developed by our group.


Eligibility Criteria:
Inclusion Criteria:

* Patient with metastatic or locally advanced cancer candidate to anti-PD1/PDL1 immunotherapy
* Performance status 0, 1 or 2 on the ECOG scale
* Written informed consent

Exclusion Criteria:

* Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
* Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
* Active autoimmune diseases, HIV, hepatitis C or B virus
* Patients with any medical or psychiatric condition or disease,
* Patients under guardianship, curatorship or under the protection of justice.
Correlation Between Preoperative Images of PPGL and Intraoperative Hemodynamics

This is a retrospective observational cohort study involving patients with suspected PPGLs who underwent 131I-MIBG scanning and surgical treatment between January 2020 and April 2023. The objective is to evaluate the correlation between MIBG imaging score and intraoperative hemodynamic fluctuations.

This is a retrospective observational cohort study involving patients with suspected PPGLs who underwent 131I-MIBG scanning and surgical treatment between January 2020 and April 2023. The objective is to evaluate the correlation between MIBG imaging score and intraoperative hemodynamic fluctuations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected PPGLs who received 131I-MIBG scintigraphy and were treated by surgery

Exclusion Criteria:

* 1) surgery was performed more than 6 months after 131I-MIBG scintigraphy; 2) tumor located in bladder where radioactive urine would influence assessment of tumor; 3) tumor was not resected as a whole; 4) resected tumor was not PPGLs confirmed by pathology; 5) 131I-MIBG scintigraphy images or intraoperative BP was not available for assessment.
Study of Neoadjuvant Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma

The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of induction chemotherapy using gemcitabine and cisplatin in NPC patients.

Patients presented with non-keratinizing NPC and stage Ⅲ-Ⅳb T3-4N1M0/TxN2-3M0 are randomly assigned to receive induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy (investigational arm) or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical Intensity modulated radiation therapy (Trilogy, Varian), and cisplatin (40mg/m2) every weeks for six cycles during radiotherapy. Radiation is delivered to GTV at 70 Gy in 30 fractions, CTV1 at at 60 Gy in 30 fractions and CTV2 at 54 Gy in 30 fractions. Patients in the investigational arm receive gemcitabine (1000mg/m2 on day 1,8) and cisplatin (20mg/m2 on day 1-4) every three weeks for two cycles before the radiotherapy. The primary end point is response rates after radiotherapy, failure-free survival (FFS) and toxic effects and treatment compliance. Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS). All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO 2005) histologically type).
* Karnofsky scale (KPS) \> 70.
* Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III：T1-2N2M0, T3N0-2M0 Stage IVa：T4N0-2M0 Stage IVb：Any T、N3.
* Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
* Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
* Adequate renal function: creatinine clearance ≥60 ml/min.
* Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

* WHO Type keratinizing squamous cell carcinoma.
* Age \>60 years or \<18 years.
* Treatment with palliative intent.
* Pregnancy or lactation.
* Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
* Any severe intercurrent disease including unstable cardiac disease, chronic hepatitis, renal disease, diabetes with poor control, and emotional disturbance.
A Multi-Center Study of Lapatinib in Patients With Trastuzumab-refractory Metastatic Breast Cancer

Evaluating the Efficacy of Lapatinib in Combination With Chemotherapy in Patients With Trastuzumab-refractory Metastatic HER2-positive Breast Cancer.

Some studies has demonstrated that even in trastuzumab pretreated patients with HER-2 positive breast cancer, might benefit from the treatment of trastuzumab. However, there is small benefit for some patients having short disease-free survival after adjuvant trastuzumab or short progression-free survival after first-line trastuzumab-based therapy. In clinical practice, the investigators also found it is fact. And the investigators have a scientific rationale for clinical testing of lapatinib plus chemotherapy in patients with trastuzumab-refractory, metastatic HER2-positive breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* HER2-expressing primary or metastatic tumor
* Recurrence within 1 year completing adjuvant trastuzumab OR rapid progress following first-line trastuzumab-based care.
* Measurable disease with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Normal organ function, including bone marrow function, renal function, liver function, and cardiac function
* Signed and dated an informed consent form
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Pregnant or breast feeding
* left ventricular ejection fraction (LVEF) \< 45% by echocardiogram
* Disease-free interval (DFI) less than 12 months
* Uncontrolled medical problems
* Any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin
* Patients were unable or unwilling to comply with program requirements
Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain

Peripheral neuropathy is a frequent condition, commonly associated with pain. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity and is regarded as one of alternative methods to alleviate pain associated with various kind of neuropathies. rTMS is usually performed once a day and the whole therapy of neuropathic pain lasts one week. In a number of recent clinical trials including patients with depression and some other disorders, rTMS was delivered several times a day, which reduced the time of the whole therapy. This approach was termed an accelerated rTMS. The purpose of this study is to investigate feasibility of accelerated rTMS in treatment of neuropathic pain.

Peripheral neuropathy is a frequent condition, commonly associated with pain, which is often drug resistant. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity. In this method, series of magnetic stimuli are delivered to the cerebral cortex, where they turn to electric current and depolarize repetitively the targeted neurons. If the stimulation is repeated during subsequent days it is capable to modify the activity of targeted cortical area for weeks or even months and by this way to achieve therapeutic effect. rTMS is most commonly used to treat drug-resistant depression but a number of other psychiatric and neurologic conditions is increasingly being regarded as therapeutic indication for rTMS. In patients suffering from neuropathic pain rTMS is delivered with high frequency, over primary motor areas (PMA). Stimulation of PMA should result in modulation of thalamic activity, achieved by antidromic excitation of thalamocortical connections. rTMS is usually performed once a day and the whole therapy of neuropathic pain lasts one week. In a number of recent clinical trials including patients with depression and some other disorders, rTMS was delivered several times a day, which reduced the time of the whole therapy. This approach was termed an accelerated rTMS. The purpose of this study is to investigate feasibility of accelerated rTMS in treatment of neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of peripheral neuropathy
* Neuropathic pain of constant severity since not less than a month and requiring use of analgesics more than once a week
* Score of 30 millimeter or more on the 100 millimeter visual analog scale of pain intensity at inclusion

Exclusion Criteria:

* Severe depression
* Personality disorders and other psychiatric conditions, which could disturb the participation in the study
* Cognitive deficits, which could disturb the participation in the study
* Epilepsy
* Presence of magnetic material in the reach of magnetic field
* Pregnancy
* Likelihood to get pregnant
* Intracranial electrodes
Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD), which encompasses ulcerative Colitis (UC) and Crohn's Disease (CD), has seen significant improvements in patient outcomes with biologic treatments. However, nearly half of the patients are either primary or secondary non-responders to the existing biologics. Upadacitinib is the only oral small molecule targeted drug approved for IBD in China. There is a paucity of research on the efficacy and safety of upadacitinib in treating Chinese patients with UC and CD, and a lack of study data on the Chinese IBD population. This study aims to conduct a multicenter, single-arm, prospective, observational real-world study to analyze the efficacy and safety of upadacitinib in the treatment of Chinese patients with IBD, providing a basis for clinical decision-making.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were patients of any gender, diagnosed with ulcerative colitis or Crohn's disease according to current guidelines, requiring initial upadacitinib treatment as judged by the treating physician, and providing signed informed consent.

Exclusion Criteria:

* Exclusion criteria included current or planned participation in any other clinical study, contraindications to upadacitinib treatment as per the drug's instructions, and patients deemed unsuitable for the study by the researchers.
ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry

The primary objective of this registry is to obtain long-term outcomes on ProChondrix CR in cartilage repair procedures of the knee, ankle, foot and hip.

This multi-center, observational registry will be used to evaluate the effectiveness of ProChondrix CR in patients who undergo treatment for an articular cartilage defect in the knee, ankle, foot or hip.

This registry will be performed at up to 30 clinical sites across the United States.

Patient follow-up will occur following an articular cartilage repair procedure in which the patient receives ProChondrix CR. During this follow-up period, each patient will be evaluated at least four (4) times at: 3, 6, 12 and 24 months after surgical intervention and will continue annually for as long as patients are willing to fill out questionnaires and outcomes assessments up to 10 years post operatively.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed by physician to have a cartilage defect in the knee, ankle, foot or hip that requires surgical intervention;
* Will be having, or has had, a cartilage repair procedure using ProChondrix CR;
* Has the ability to understand the requirements of the registry, to provide written informed consent and to comply with the registry protocol;

Exclusion Criteria:

• Is a ward of the state, prisoner, or transient.
Improving Outcomes in Cancer Patients With a Nutritional and Physical Conditioning Prehabilitation Program

Major surgery is a stressful procedure; good recovery after surgery is important to patients and their doctors. Studies done at the McGill University Health Centre (MUHC) with cancer patients awaiting surgery have shown that exercise combined with simple diet recommendations (which may include a supplement) and relaxation techniques before surgery helped speed up the ability to resume walking after surgery.

These results have made the investigators aware that exercise and good nutrition are as important before surgery as they are after surgery; while it is common practice to start strengthening the body after surgery (rehabilitation), there may be some advantage to begin this process before surgery (prehabilitation).

The purpose of this study is to see if the following program, either before or after surgery, can help patients recover from liver, pancreas or bile duct surgery:

1. Exercise that may help participants move and breath better,
2. Nutrition advice and a supplement to make participants strong,
3. Relaxation and anti-anxiety tips to help cope with the stress of upcoming surgery

The investigators will see if following this program will have an effect on participants' ability to walk before and after surgery.


Eligibility Criteria:
Inclusion criteria:

* A diagnosis or suspicion of either hepatobiliary or pancreatic cancer (primary or metastatic)
* Must be scheduled for surgical resection between 4-6 weeks of recruitment

Exclusion criteria:

* Persons with American Society of Anesthesiologists (ASA) health status class 4-5
* Comorbid medical, physical and mental conditions (eg: dementia, disabling orthopedic and neuromuscular disease, psychosis)
* Cardiac abnormalities
* Severe end-organ disease such as cardiac failure, chronic obstructive pulmonary failure and hepatic failure (alanine aminotransferase and aspartate aminotransferase \>50% over the normal range)
* Sepsis
* Morbid obesity (BMI \>40)
* Anemia (hematocrit \<30 %)
* Other conditions interfering with the ability to perform exercise at home or to complete the testing procedures
* Poor English or French comprehension
Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Intestinal Anastomosis

Intestinal anastomosis plays an important role in various general surgeries, but the complications such as anastomotic leakage,stenosis and hemorrhage cannot been avoided. Although many ways are put up to solve this problem, there are still many imports need to improve. Therefore, the Biodegradable Stenting Anastomoses(BSA), which make intestinal anastomosis easily and less complications, have been produced.The major goal of this study is to evaluate the efficacy of Biodegradable Stenting Anastomoses(BSA) for reconstruction in surgery of intestinal anastomosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with age between 18 - 80 years.
* Patients with operation of end to end anastomosis of colon or small intestine.
* Patients without previous surgery during 3 months.
* Patients who understand the nature of this trial and provide informed consent.

Exclusion Criteria:

* Patients with severe cardiopulmonary disease or other severe disease.
* Patients who are psychopath, pregnant, and child without capacity for civil conduct.
* Patients with complete intestinal obstruction.
* Patients with abdominal cavity infection.
* Patients who are treating by drug such as adrenal cortical hormone and immune inhibitors, chemotherapy drugs, radiation and so on.
* Patients who need to accept the anastomosis between rectum and colon.
* Patients who are required to accept intestinal anastomosis twice or more.
* Patients who are required to accept the treatment of colostomy.
* other conditions that render a patient unsuitable for the trial as determined by the study investigators.
Exercise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Breast Conservation Therapy for Women With Early Stage Breast Cancer

The purpose of this research study is to find out if a monitored group exercise program can increase strength, muscle mass and ability to move in women after treatment for early stage breast cancer.

This trial will assess the safety and feasibility of a monitored group exercise regimen utilizing high-load resistance training and functional exercises with compound movements in a group of women treated for early stage breast cancer with the goal of improving functional mobility, body composition, and strength after breast conservation therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age 30-70 years
2. Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
3. Women must have undergone breast conservation therapy with no neoadjuvant or adjuvant chemotherapy (adjuvant endocrine therapy is permitted)
4. BMI \> 25 kg/m2 or body fat% greater or equal to 31%
5. Participants must have abstained from smoking for at least 12 months
6. Women of child-bearing potential must verbally confirm lack of pregnancy prior to enrollment and have undergone a pregnancy test prior to initial of radiation therapy (standard protocol for radiation therapy). They should also consent to use adequate contraception during the course of the study.
7. Women must be determined capable of engaging in resistance training as documented in treating radiation oncologist notes.
8. Participants must have a schedule amenable to three prescheduled workout sessions per week, scheduled during the day.
9. Women must complete a Functional Mobility Screen (FMS) and determined safe to engage in the workout regimen by the study personnel.

Exclusion Criteria:

1. Any treatment with chemotherapy for recent breast cancer treatment
2. Mastectomy and/or lymph node dissection
3. Uncontrolled hypertension or diabetes, defined as systolic blood pressure over 149, diastolic blood pressure over 99, and hemoglobin A1c greater than 8.9.
4. Diabetic condition requiring the usage of insulin
5. Severe arthritic, joint, cardiovascular, or musculoskeletal condition
6. Inability to perform body weight squat exercise without pain assessed by treating radiation oncologist
7. History of myocardial infarction or coronary artery disease
Physiological Constraints Associated With Trail Running

The practice of mountain running or "trail" is in full development in France and elsewhere in the world. This sporting practice associates specific physiological constraints related in particular to the duration of the efforts made (several hours) and to the ground (important elevation, technical ground, average altitude). Some studies have allowed the last 10 years to initiate the exploration of the physiological consequences of this type of practice, especially from a muscular point of view. However, some important questions remain to be clarified such as the impact of these sports events on fatigue and muscle recovery, cardiovascular, energy and water balance disturbances caused, induced sleep changes and the kinetics of recovery of the various parameters. . These elements remain in particular to be studied in very different racing contexts as currently developed by the organizers, namely race in one stage from long to very long distances (40 to 160 km) and race in stages (4 days, 4 x 40 km) as encountered in the Grenoble UT4M race (Ultra Tour des 4 Massifs).


Eligibility Criteria:
Inclusion Criteria:

* Man or woman
* 18-55 years
* Absence of chronic cardiovascular, respiratory, metabolic or neuromuscular disease
* \> 3 years of trail running (at least 1 race\> 40 km / year completed and a race\> 100 km completed (trail group 160 km)
* Medical certificate of no contraindication to the practice of the trail
* Subjects available in Grenoble before and within 15 days after the race
* Subjects affiliated to a social security scheme
* Subjects able to sign informed consent.

Exclusion Criteria:

* Cardiorespiratory, metabolic and neurological diseases
* Non-Echogenic Subjects
* Subjects with chronic sleep disorders
* Psychiatric pathologies or ATCD of behavioral disorders
* Persons refusing to sign the information sheet and the participation agreement,
* persons under guardianship or not subject to a social security scheme,
* Pregnant woman, parturient, breastfeeding mother
* Person deprived of liberty by judicial or administrative decision,
* Person subject to a legal protection measure, who can not be included in clinical trials.