cyrilzakka/clinical-trials huggingface dataset:
Fludeoxyglucose F 18 in Detecting Lymph Node Metastasis in Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed by Surgery

RATIONALE: Diagnostic procedures using fludeoxyglucose F 18 and a surgical probe may help find lymph node metastases in patients with early-stage non-small cell lung cancer.

PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 works in detecting lymph node metastasis in patients with stage I or stage II non-small cell lung cancer that can be removed by surgery.

OBJECTIVES:

Primary

* Determine the positive threshold of lymph node radioactivity after fludeoxyglucose F 18, utilizing the gamma probe, in patients with resectable stage I or II non-small cell lung cancer.
* Compare the accuracy of detecting thoracic lymph node metastases using positron emission tomography-computed tomography (PET-CT) versus the intra-operative hand-held gamma probe in these patients.
* Determine the ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging in these patients.
* Assess the clinical relevance of the gamma probe-detected lymph node metastases by measuring patient survival, tumor recurrence, impact on patient quality of life, and cost.

OUTLINE: Patients undergo a positron emission tomography-computed tomography (PET-CT) scan within 90 days before surgery. Beginning 1-4 hours before surgery on day 1, patients receive an injection of fludeoxyglucose F 18 (FDG) and a mediastinoscopy is performed. FDG-avid lymph nodes are obtained and may undergo immunohistochemical analysis or standard analysis. Patients with mediastinal lymph node micrometastasis do not undergo primary tumor resection. Patients with ipsilateral mediastinal micrometastases undergo neoadjuvant chemotherapy prior to surgical resection. Patients with contralateral mediastinal micrometastases undergo definitive chemoradiotherapy. In the absence of mediastinal lymph node metastases (micro or macro), complete surgical resection is performed after the mediastinoscopy, including complete thoracic lymphadenectomy. The tumor and lymph nodes (both from mediastinoscopy and thoracotomy) undergo radioactivity measurements with the hand-held gamma probe. Fresh tumor and lymph node samples are stored for future studies.

Patients complete the Short Form 36 Health Survey (SF-36) before surgery and at 1, 3, and 6 months after surgery to assess the potential impact of the gamma probe on patient quality of life.

After completion of study, patients are followed every 6 months for 2 years, and then annually for 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of non-small cell lung cancer

  * Stage I-II disease
  * Resectable disease
* Planning to undergo surgical resection
* No tumors that are not fludeoxyglucose F 18 (FDG)-avid on PET scan

PATIENT CHARACTERISTICS:

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No previous allergic reaction to fludeoxyglucose F 18
* No contraindication to a pulmonary lobectomy and lymphadenectomy

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy

Open clinical trial addressing the effect of a nutritional support based on whey proteins, leucine and vitamin D on muscle mass and multiple anticancer treatment-related endpoints in patients with gynecologic cancer receiving first-line platinum-based chemotherapy (adjuvant or curative). A comparison to matched historical controls will be performed to address potential evidence of efficacy to be investigated in a subsequent randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed diagnosis of gynecologic cancer (ovarian, uterine, cervical);
* indication for a first-line chemotherapy (adjuvant or curative) with a platinum-based regimen to be used by investigator's choice within the framework of good clinical practice and in agreement with current Italian Association of Medical Oncology guidelines;
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
* signed informed consent.

Exclusion Criteria:

* age \<18 years
* ECOG performance status \>2
* indication to or ongoing artificial nutrition support
* known kidney failure (previous glomerular filtration rate \<30 ml/min);
* known liver failure (Child B or C)
* endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
* decompensated diabetes
* indications related to the study product: more than 10 µg (400 IU) of daily Vitamin D intake from medical sources More than 500 mg of daily calcium intake from medical sources; adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study.
* known allergy to milk, milk products or other components of the proposed interventions
* inclusion in other nutritional intervention trials
* patients refusal
Effect of Dapagliflozin on Glycemic Variability

Dapagliflozin improves glycemic variability in subjects with type 2 diabetes mellitus when added to insulin therapy. The primary objective of this study is to assess the effect of dapagliflozin on glucose variability compared to placebo after 12 weeks of treatment in type 2 diabetic patients with inadequate glycemic control on insulin.

This study is a multicenter, randomized, double-blind, placebo-controlled phase 4 study to evaluate whether treatment with dapagliflozin add-on to insulin reduces glucose variability in type 2 Diabetes Mellitus. The study will recruit type 2 Diabetes Mellitus patients with inadequate glucose control on insulin treatment with or without metformin or sulphonylurea. It is estimated that 90 type 2 diabetic patients will be enrolled. After randomization, a total 12 week treatment of dapagliflozin or matching placebo will be administered. Before and after treatment, tests for efficacy and safety outcomes will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Female and male aged 20\~70 years
2. Type 2 diabetes patients
3. Treatment on basal insulin therapy ≥0.2U/kg/day(±metformin and/or ±sulfonylurea) for at least 12 weeks
4. Inadequate glycemic control ; HbA1c 7.0%\~10.0% at screening
5. Female of childbearing potential agrees to routinely use of adequate contraception from signing of the informed consent throughout the duration of the study
6. Understands the study procedure, alternatives, and risks and voluntarily agrees to participated by giving written informed consent

Exclusion Criteria:

1. Type 1 diabetes(Fasting C-peptide ≤ 0.78ng/dL(or 0.26 nM/L)), secondary diabetes, gestational diabetes
2. Insulin therapy modalities containing short or rapid acting insulin (continuous subcutaneous insulin injection, pre-mixed insulin, basal-bolus insulin)
3. History of diabetic ketoacidosis, hyperglycemic hyperosmolar state
4. Estimated glomerular filtration rate \<60 mL/min/1.73 m2
5. History of chronic cystitis or recurrent urinary tract infection
6. Currently on loop diuretics
7. Adrenal insufficiency, pituitary insufficiency
8. Currently on medication known to affect glucose metabolism (e.g. corticosteroids, immunosuppressants)
9. Hemoglobin \<10g/dL in female, \<12g/dL in male
10. Abnormal liver function (AST/ALT \> x3 upper normal limit)
11. On weight loss program or taking weight loss medication
12. NYHA class III, IV congestive heart failure
13. History of acute myocardial infarction, unstable angina, coronary artery bypass graft or stroke within 6 months
14. History of bladder cancer
15. History of malignancy within 5 years
16. Pregnant or lactating women
17. History of excessive alcohol abuse (≥30g/day)
18. Hypersensitivity to SGLT2 inhibitors
19. Patient with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
20. Subject who the investigator deems inappropriate to participate in this study
Biomimetic Hydroxyapatite in Pediatric Patients With Asthma and/or Allergic Rhinitis

The aim of the study is to compare the incidence of dental caries and the level of demineralization in pediatric patients with asthma and/or allergic rhinitis.

Patients will conduct professional oral hygiene at the baseline. The following clinical indexes will be assessed: BEWE Index, Plaque Index, Bleeding Score, Schiff Air Index. Then, patients will be randomly divided into two groups:

* Trial group: domiciliary use of Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment twice a day
* Control group: domiciliary use of Elmex Caries Protection twice a day

The clinical indexes will be assessed again after 1 month (T1), after 3 (T2) and 6 months (T3).


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients aged between 6-14 years
* diagnosis of allergic rhinitis and asthma
* therapy with salmeterol/fluticasone propionate
* diffused enamel demineralizations of deciduous and permanent teeth

Exclusion Criteria:

* low cooperation according to grades 3 and 4 of Frankl behavioral scale
* nonadherence to the study protocol checked by parents
* other systemic diseases.
Hand Rehab Using AMADEO in PD Patients

Hand movements are particularly impaired in Parkinson's Disease (PD) patients contributing to functional disability and difficulties in activities of daily living. AMADEO®. is an end-effector system enables intensive training with frequently repeated gripping movements. It offers the possibility to select from between passive, assistive and active modes using exercise of finger strength, finger movement, movement control and a selective activation of the fingers.Aim of this study is to evaluate the efficacy of the end-effector finger system, AMADEO®, on hand-finger movements in PD patients evaluating the improvement on finger tapping and agility of hand movement item scores on the MDS-UPDRS, variation on the active finger strengths and the active and passive Range of Motion (ROM); variation on Electromyographic (EMG)-parameters.


Eligibility Criteria:
Inclusion Criteria

* Idiopathic PD diagnosed according to the Gelb's criteria;
* Hoehn-Yahr stage 1- 3
* "On" state
* MMSE score ≥ 24
* Willing and able to give written informed consent;
* Willing and able to comply with the study procedures.

Exclusion Criteria

* A specific kind of fluctuation: Sudden on-off fluctuations
* History sign or symptoms suggesting the diagnosis of atypical or secondary Parkinsonisms;
* History of stereotaxic brain surgery for PD;
* Mini-mental examination (MMSE) score less than 24 at screening;
* Changes in Levodopa (DA) dose in any time within 4 week prior to baseline;
* Changes in Dopamine Agonists (DA) in any formulation in any time within 4 week prior to baseline;
* Presence of severe dyskinesia prior to baseline;
* Any other medical or psychiatric condition that may compromise the patient's participation in this study;
Effects of Creatine Supplementation as Compared to Glucosamine/Chondroitin Sulfate Supplementation in Addition to Exercise and Physical Therapy in the Management of Knee Osteoarthritis.

Osteoarthritis (OA) is one of the most common joint disorders, affecting not only the joints but also the surrounding muscles, which become weak. Resistance exercise reduces pain and improves function in patients with OA of the knee. Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used by patients with OA to reduce pain and thereby maintain the ability to perform daily activities. However, there is accumulating evidence for a negative effect of NSAIDs, thus many patients with OA are treated with dietary supplementations such as glucosamine and chondroitin sulfate, and some studies show a beneficial effects on cartilage and pain. However, their effect on OA symptoms and cartilage remains controversial. On the other hand creatine supplementation has also been observed to show promising effects when combined with resistance training exercise in the elderly, but the evidence is limited in terms of knee osteoarthritis. For this reason the purpose of this study is to determine the effects of creatine supplementation as compared to glucosamine/chondroitin sulfate in the management of knee osteoarthritis when combined with resistance training exercise.


Eligibility Criteria:
Inclusion Criteria:

* Age 40-70 years
* Knee OA with history not less than three months.
* Radiological evidences of grade III or less on Kellgren classification.
* Knee pain on VNRS no more than 8/10

Exclusion Criteria:

* Neuromuscular conditions that may lead to fatigue such as multiple Sclerosis
* Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection).
* History of trauma or fractures in lower extremity.
* Signs of lumbar radiculopathy or myelopathy.
* History of knee surgery or replacement.
* Patients on intra-articular steroid therapy within two months before the commencement of the study.
* Impaired skin sensation.
* Impaired renal function
Simulation-based Training for Flexible Cystoscopy - a Patient Transfer Randomized Trial

Simulation training in surgical education in Urology specialist training in flexible cystoscopy has been demonstrated a valid and efficient learning instrument. The classical setup with a medical expert introducing the novices to the theoretical background and technics of the procedure is time-consuming and expensive. Directed self-regulated simulation training (DSR) is a validated method in simulation training. The power of testing in DSR and flexible cystoscopy is to our knowledge not known. We introduced a setup in which the novices started by training in a directed self-regulated simulation training environment and informed them that they would be tested by a medical expert afterwards. The intervention group novices were given only written theoretical information and anatomical pictures. The control group were first given a classical oral theoretical introduction by a medical expert and secondly did DSR training. We tested the outcome of the intervention by a validated rating scale for flexible cystoscopy. The novices in both the control and intervention group were tested on patients prescribed a flexible cystoscopy and evaluated by a specialist in Urology.

The main hypothesis was that testing in relation to DSR would result in higher scores on a validated scale when performing a flexible cystoscopy on a patient evaluated by a specialist in Urology compared to a group having a oral lecture before DSR.


Eligibility Criteria:
Inclusion Criteria:

* Senior medical students
* Novices in endoscopic procedures
* Written and oral consent

Exclusion Criteria:

* Performed a endoscopic procedure independently
* Lack of language skills
* Lack of written and oral consent
The Complex Regional Pain Syndrome (CRPS) is a Chronic Pain Condition. This is a Preliminary Study to Explore and Test Clinical Hypothesis. They Suppose That CRPS Patients Have Impairment in Their Mental or Motor Imagery Abilities.

Medical functional imagery seems to demonstrate that patients suffering from complex regional pain syndrome (CRPS) have cortical modifications that alter their motor (or mental) imagery capacities. Nowadays, the use of motor imagery exercises are used in conventional rehabilitation treatments. But, in clinical practice, no study has verified if patients with CRPS desmonstrate problems in their motor imagery capacities. The MIQ-RS (Motor Imagery Questionnaire - Revised Second) is a valid, reliable and translated into French questionnaire to measure patients' capacities to do mental imagery. In this study, we compare 3 groups of 50 patients : healthy patients, patients with CRPS and patients with musculoskeletal disorder without CRPS. Every patient will take the MIQ-RS for the right and left body side. We hypothesis that patients with CRPS have more deficit than the 2 others to realise motor imagery.


Eligibility Criteria:
Inclusion Criteria:

* Patient with French healthcare affiliation
* Adult patient (\> 18 years old)
* Patient with bachelor degree minimum
* Patient practicing less than 150 minutes of moderate to intense physical activity per week

Specific Inclusion Criteria for CRPS group :

* Patient followed in the Evaluation and Treatment pain center (University Hospital of Nimes)
* Patient with secondary CRPS due to a traumatism or a surgery

Specific Inclusion Criteria for Musculoskeletal group :

* Patient with musculoskelettal disorder on a limb (upper or lower)
* Patient followed in the University Hospital of Nimes

Non inclusion Criteria :

* Patient who participates in another category 1 research
* Patient in a exclusion period in another study
* Patient under legal protection, under guardianship or under curatorship
* Patient for whom it is impossible to give clear information.
* Pregnant, parturient or breastfeeding patient.
* Patient with amputation on one of his limb
* Patient with visual cecity
* Patient who has already practiced mental imagery
* Patient with neurological impairment
* Patient with chronic low back pain and fibromyalgia

Specific non inclusion criteria for Musculoskeletal group and healthy group :

-Patient with CRPS

Specific non inclusion Criteria for CRPS group :

* Secondary CRPS to CVA (cerebrovascular accident)
* Patient receiving lymph node block treatment between the inclusion visit and the follow-up visit

Specific non inclusion Criteria for Musculoskeletal Disorder group :

* Patient with secondary musculoskeletal disorder to a CVA

Exclusion criteria :

* Questionnaire MIQ-RS not completed or non respect with the research protocol
* pathology discovered incompatible with the study criteria
A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer

The purpose of this randomized, Phase 2 open-label study was to assess the response rate of participants with Human Epidermal Growth Factor Receptor 2 (Her2+) locally advanced and/or metastatic breast cancer (not previously treated with chemotherapy or trastuzumab) to treatment with ixabepilone plus trastuzumab and/or docetaxel plus trastuzumab.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic HER2+ breast cancer not previously treated with chemotherapy or trastuzumab.
* Subjects who had received prior (neo)adjuvant chemotherapy or trastuzumab were eligible except if they relapsed within 12 months after the last dose of a taxane or trastuzumab given as (neo)adjuvant therapy.
* Measurable disease
* Left Ventricular Ejection Fraction (LVEF) ≥50%

Exclusion Criteria:

* Prior chemotherapy or trastuzumab for metastatic breast cancer (MBC)
* Relapse within 1 year after (neo)adjuvant taxane or trastuzumab
* Neuropathy \> Grade 1
* Significant cardiovascular disease
* Any brain metastases
Examination Of Exercise Adherence İn Lung Cancer Patients Given Calisthenic Exercise

Cancer treatments usually include surgery, chemotherapy, radiation therapy, hormone therapy, and/or a combination of these methods. These treatments cause many physical and psychological effects that interfere with functional independence, performing activities of daily living, and healthy quality of life. Mostly, depending on cancer and its treatment; Cognitive function, sleep pattern, functional capacity, pain state and bone mineral density are affected. Exercise compliance is the degree to which an individual's behavior is consistent with the health care provider's advice and treatment plan. According to the World Health Organization, compliance is "a measure of a person's behavior (such as following a recommended exercise program, monitoring drug intake, etc.). ) as a response to complying with recommendations deemed appropriate by health care professionals''. In the field of rehabilitation too, compliance is increasingly used in relation to the self-management of patients' health. It has been stated in the studies that the level of compliance with the recommended home exercise is generally low, which limits the benefits of exercise programs.

This study is a cross-sectional study. Lung cancer patients who applied to the Oncology Service and met the inclusion criteria will be included in the study. Patients will be randomly assigned to physical activity counseling and education groups.

Within the scope of the study, exercise compliance will be examined in patients with lung cancer who are given calisthenic exercise.

Participants will be evaluated before treatment, their functional capacities will be determined, their compliance with exercise, fatigue levels, pain levels, cognitive status, sleep and quality of life will be evaluated with questionnaires.

Home exercises will be taught to the physical activity counseling group and will be followed up under the supervision of a physiotherapist with weekly controls. Breathing exercises and calisthenic exercises will be taught to the training group, and participants will be followed under the supervision of a physiotherapist for 8 weeks, 3 days a week. Evaluations will be made before and after the treatment.

Individuals who do not agree to / give up participating in the study will be able to leave the study voluntarily.

All information belonging to individuals will be protected according to the personal data protection law.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose chemotherapy and radiotherapy has ended, at least 6 months and maximum 5 years after surgery
* Being between the ages of 18-65
* 3 and 5 years according to the Modified Borg Scale Patients with severe fatigue

Exclusion Criteria:

* Uncontrollable hypertension, diabetes mellitus, heart failure and atrial fibrillation
* Any acute infection during the evaluation
* Orthopedic, neurological, psychological, etc., which will limit the evaluations. with problems
DNA Repair Enzyme Signature in Head and Neck Cancer (CHEMRAD)

Squamous cell carcinoma (HNSCC) is the most frequent form of head and neck cancer. The therapeutic choice depends on the stage of the disease and the habits of the medical teams. Surgery, radiotherapy and chemotherapy can be used, alone or combined. However, none of the existing strategies has proven its superiority.

Chemotherapy and radiotherapy induce DNA damages in the tumor cells. However, cells have the ability to induce DNA reparation, capable of causing treatment resistance. DNA reparation in non-tumor tissues can also explain the toxicity of cancer treatments.

Investigation of DNA repair pathways involved in chemo- or radiation resistance could offer a good strategy for identifying biomarkers or indicators of treatment response. This study will explore the capacity of a comprehensive functional approach that addresses several pathways, based on the use of three innovative patented technologies, to classify the tumor response of HNSCC patients to treatments according to their DNA Repair Enzyme Signature.

Our hypothesis is that taking into account various clinical parameters (e.g. patient and tumor characteristics), treatment strategy and measuring the DNA Repair Enzyme Signature would create patients' profiles and optimize their management.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old;
* HNSCC proven on a biopsy, located in the oral cavity or the oropharynx (the tumor must be accessible to a biopsy during an outpatient visit);
* Tumor accessible to a biopsy under local anesthesia;
* TNM classification: any stage except M1;
* Eligible for radiotherapy as a curative treatment;
* No surgery planned as exclusive treatment;
* Able to comply with the scheduled visits;
* Affiliated to or beneficiary of a social security system (or equivalent) ;
* Having given written informed consent prior to any procedure related to the study.

Exclusion Criteria:

* Recurrence or second cancer in a previously irradiated area;
* Nasopharyngeal carcinoma;
* Tumor requiring general anesthesia to perform the biopsy;
* Radiotherapy planned to be provided outside of the investigation center;
* Pregnant or lactating woman;
* Adult ward of court (under guardianship or trusteeship).