cyrilzakka/clinical-trials huggingface dataset:
Induction CT by Cisplatin, 5FU With or Without Docetaxel in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma

The purpose of the study is to compare two regimen of chemotherapy used as first treatment for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy. The standard treatment is a combination of 2 drugs (Cisplatin and 5FU). The aim of the study is to evaluate the potential benefit of the addition of a third drug (Docetaxel) in the chemotherapy regimen. Patients will receive 3 cycles of chemotherapy. Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy.

The purpose of the study is to compare two regimen of induction chemotherapy for patients with T3 and T4 larynx or hypopharynx carcinoma that would be treated with total laryngectomy. The aim of the study is to compare the standard regimen (Cisplatin + 5FU) versus the TPF regimen (Taxotere + Cisplatin + 5FU). Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy followed by postoperative radiation.

Eligibility Criteria:
Inclusion Criteria:

* T3 and T4 larynx and hypopharynx tumor that would be treated with total laryngectomy
* Biopsy proven carcinoma
* Adequate biology
* Performance status 0 or 1

Exclusion Criteria:

* Larynx or hypopharynx tumors that could be treated with partial laryngectomy
* Distant metastasis
* Prior surgery, chemotherapy or radiation
* Intercurrent disease that is a contra indication to chemotherapy
Study on the Impact of a Modified Mediterranean Diet, in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment

The study plans to evaluate the impact of the Modified Mediterranean Diet on the biodiversity of the intestinal microbiota (the set of physiological bacteria present at the intestinal level) in patients suffering from metastatic colorectal cancer undergoing chemotherapy treatment +/- biological agent, comparing the microbiota with that of patients following a Western or standard diet.

Specifically, as well demonstrated in clinical studies, there are populations of bacteria that play a role in protecting the intestinal barrier and whose proliferation could be promoted by the Modified Mediterranean Diet.

The study also intends to evaluate the influence of the microbiome on the clinical progress of the disease in terms of side effects and quality of life.

The study will be divided into:

* Screening visit (V0) and Baseline visit (V1): during a control visit, the patient will be asked to participate in the study. After signing the written informed consent for participation in the MIC-1 study, the patient will be screened for his nutritional status. During the visit, a folder will be used to assess nutritional status. Routine blood tests will be carried out, a serum sample will be taken to measure nutritional markers and lifestyle will be assessed. Furthermore, the detection of anthropometric measurements (weight, height, BMI), bioimpedance analysis, estimation of calorie-protein needs and Malnutrition Universal Screening Tool (MUST) nutritional screening is envisaged. Once the study inclusion criteria are met, the patient will return for a visit and randomization into the study arms will take place. Arm A will then be given the modified Mediterranean diet (DMM), while arm B will continue to follow its usual diet. The patient will deliver the fecal sample. Subsequent patient visits will take place every 15 or 21 days depending on the ongoing therapy.
* Visit V2: this visit will be carried out approximately 45 days after the baseline visit. The patient will deliver the stool sample.
* Visit V3: this visit will be carried out approximately 90 days after the baseline visit. During this visit, as per clinical practice, the radiological re-evaluation will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group performance status (ECOG): 0 or 1;
* Age ≥ 18;
* Diagnosis of metastatic colorectal cancer, documented histologically and radiologically according to RECIST 1:1 criteria;
* 1st line chemotherapy treatment +/- biological agent (anti-EGFR, anti-VEGF);
* MUST score 0/1;
* Written informed consent.

Exclusion Criteria:

* Previous oncological medical therapies;
* Indication for parenteral and/or enteral nutrition;
* MUST score \> 2.
Pulse Wave Analysis and Velocity in Patients With Chronic Renal Failure: a Cross-sectional Observational Study to Assess Association With Left Ventricular Hypertrophy, Uremic Toxins and Inflammation.

The aims of the presented study are as follows:

1. To evaluate the endothelial function and arterial stiffness in a large cohort of prevalent CKD patients by means of non-invasive applantion tonometry.
2. To evaluate the association between the serum levels of the representatives of the various classes of uremic toxins and markers of endothelial function and arterial stiffness.
3. To evaluate the association between markers of inflammation and oxidative stress and markers of endothelial function and arterial stiffness.
4. To evaluate the association between echocardiographic parameters and markers of arterial stiffness


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-60
* Chronic kidney disease: according to the K-DOQI guidelines ( kidney damage ≥ three months, as defined by structural or functional abnormalities of the kidney, with or without decreased GFR, manifest by either: pathological abnormalities; or markers of kidney damage, including damage in the composition of blood or urine test, or abnormalities in imaging tests; GFR\< 60 ml/min/1.73m² for ≥ three months, with or without kidney damage)
* Written informed consent

Exclusion Criteria:

* major illnesses( life expectancy of \< 1 year)
* history of atrial fibrillation
* history of myocardial infarction, unstable angina, congestive heart failure, peripheral vascular diasease ,cerebrovascular disease, diabetes

(nonechogenic)
The Efficacy of Suprascapular Nerve Radiofrequency and Intra-articular Steroid Injection in Frozen Shoulder Treatment

The aim of this clinical study is to compare the effectiveness of suprascapular nerve pulsed radiofrequency and intra-articular steroid injection in patients with frozen shoulder (adhesive capsulitis). The main questions it aims to answer are:

1. What is the effectiveness of intra-articular steroid injection in frozen shoulder?
2. What is the effectiveness of suprascapular nerve radiofrequency in frozen shoulder?
3. Should these two methods be used together in frozen shoulder?


Eligibility Criteria:
Inclusion Criteria:

* unilateral side involvement.
* ≥50% loss of passive ROM (external rotation or abduction) in the glenohumeral joint comparing to the unaffected side.
* duration of symptoms ≥3 months.
* age≥ 20year old.
* Patients with VAS ≥4 before the procedure

Exclusion Criteria:

* ever received manipulation of the affected shoulder with/without anesthesia. systemic disease, severe degeneration, or trauma involving the shoulder. (ie, rheumatoid arthritis, osteoarthritis, history of injury to the labrum or articular cartilage or malignancies in the shoulder region, etc.)
* neurologic diseases such as stroke or peripheral nerve neuropathy that have already affect the activity of shoulder.
* pain or disorders of the cervical spine, elbow, wrist, or hand.
* a history of drug allergy to local or corticosteroids.
* Pregnancy or lactation.
* Received corticosteroids, or hyaluronic acid intra-articular injection into the affected shoulder during the preceding 4 weeks.
* Patients with VAS \<4 before the procedure
Femoral Tunnel Position on Conventional MRI After Anterior Cruciate Ligament Reconstruction-Transtibial Technique Versus Transportal Technique

The position of the femoral tunnel in anterior cruciate ligament (ACL) reconstruction has been assessed on three dimensional CT (3D-CT) scan or in cadaveric study. However, these methods have some issues; 3D-CT scan has a concern on radiation exposure and cadaveric study is not easily available nor an in vivo test. The purpose of this study is to compare the position of the femoral tunnel aperture on conventional MRI and the outcomes after single bundle ACL reconstruction using free tendon Achilles allograft between transportal technique and transtibial technique in active young men.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of anterior cruciate ligament rupture

Exclusion Criteria:

* female
* over 45 years old
* the subjects who had ACL reconstruction with graft other than Achilles allograft
* the subjects who had concomitant other ligament injuries on the same knee needing surgical treatment
* revision ACL reconstruction
* double bundle ACL reconstruction
* concomitant full thickness cartilage injury needing cartilage repairing surgery
The Effect of a Short Term Exercise Schedule on Oral Iron Bio-availability and Iron Incorporation

Iron metabolism may undergo changes during exercise, with reductions in classical iron status markers due to a variety of postulated mechanism which include hemodilution, increased iron loss, hemolysis and increased iron storage in muscles. Furthermore, it has been reported that vigorous training increases hepcidin, a central regulatory peptide in iron metabolism. This increase has been ascribed to the presence of subclinical inflammation. Increased hepcidin levels may reduce iron bioavailability and iron incorporation in erythrocytes.

Twenty healthy men subjects will be recruited as subjects for this study. Subjects should be generally healthy, with no history of blood donation in the last 6 months, should weigh less than 85 Kg, and not take iron supplements and/or multivitamin supplements. Subjects should have familiarity to sports and running, but not currently (i.e. in the past 3 months) training for more than 1h per week on average.

The aim of this study is to measure an iron bioavailability during a resting and an exercise phase lasting approx. 14 days with training sessions on alternate days. Subjects will participate in both restign and exercising protocols and act as their own controls during the study. Iron bioavailability will be measured via the incorporation of stable isotopic labels 14 days after administration. To control for changes in blood volume during the course of the study, blood volume of the participating subjects will be measured before and after the exercise phase with the CO-rebreathing method.

Measurement of iron bioavailability and iron incorporation in a resting and exercising phase will allow determine if the increased level of hepcidin seen in in exercise will induce a lower iron bioavailability and iron incorporation during exercise.


Eligibility Criteria:
Inclusion Criteria:

* men, Generally Healthy age between 18-50 years;
* BMI between 18-25;
* nonanemic (Hb \< 120 g/L);
* no intake of vitamins and nutritional supplements;
* no recent blood donation (\<4 months);
* no previous participation in studies with stable iron isotopes in the past.

Exclusion Criteria:

* Chronic diseases, Metabolic diseases, GI tract diseases (self reported)
Clinical Efficacy and Safety of Leflunomide in Egyptian Patients With Active Rheumatoid Arthritis

A Phase IV, Multi-Centric, Prospective, Observational Study to Assess the Clinical Efficacy and Safety of Leflunomide in Egyptian Patients with Active Rheumatoid Arthritis. (CLEAR)

CLEAR is a phase IV, multi-centric, prospective, observational study to assess the clinical efficacy and safety of Leflunomide as first-line therapy and as add-on therapy to other DMARDs (such as Methotrexate, Hydroxychloroquine, Sulfasalazine) with or without Steroids use in Egyptian patients with Active Rheumatoid Arthritis.

Eligibility Criteria:
Inclusion Criteria:

1. Active Rheumatoid Arthritis patients selected according to the ACR/EULAR classification 2010 criteria with score ≥ 6 points.
2. Male or female patients aged 18-60 years old.
3. Leflunomide naïve patients or patients with previous Leflunomide administration (after at least 6 month wash out period from date of baseline visit) who will be prescribed Leflunomide at the sole decision of the treating physician.
4. Patients with or without another DMARDs including Methotrexate, Sulfasalazine and/or Hydroxychloroquine with or without steroids use who experienced therapy resistance, inadequate response or intolerance.
5. Patients read, understand and signed informed consent prior to inclusion.
6. Patients willing to complete and literate in the language of the available Health Assessment Questionnaire (HAQ Disability Index) either alone or with minimal assistance from caregivers and/or trained site personnel.

Exclusion Criteria:

1. Female patients who are pregnant or lactating at the time of inclusion or those who are planning for pregnancy within the coming year from the time of inclusion to the study.
2. Patients with contraindications to active constituent of Leflunomide.
3. Patients with severe concurrent infection (necessitating IV antibiotics or hospitalization).
4. Patients with history of non-treated hepatitis B \&/or C infection.
5. Patients with history of severe liver disease (child C class).
6. Patients with history of severe renal insufficiency (creatinine clearance ≤30 ml/min.).
Analysis of the Electrical Muscle Activity and Resistance to Movement in Spastic Hemiparetic Patients.

To evaluate and compare the effects of Neuromuscular Electrical Stimulation when applied in the agonist and antagonist muscles of spastic hemiparetic patients.

The specific objectives are:

* Evaluate the resistance movement, strength and muscle electrical activity before and after application of Neuromuscular Electrical Stimulation in spastic muscle (gastrocnemius).
* Evaluate the resistance movement, strength and muscle electrical activity before and after application of Neuromuscular Electrical Stimulation in the spastic antagonist muscle (tibialis anterior).
* Compare the risk of falls after application of Neuromuscular Electrical Stimulation in both muscles studied.

Most hemiparetic patients can develop spasticity, characterized by neuronal hyperexcitability, increased resistance to passive stretch, Babinski sign, clonus, reflexes and involuntary spasms skin.

As a consequence, there may be contractures and muscle shortening, generating functional limitations. Neuromuscular Electrical Stimulation feature that can control the spasticity through reciprocal inhibition, muscle relaxation and sensory stimulation. The goal will be to evaluate and compare the effects of neuromuscular electrical stimulation when applied in the agonist and antagonist muscles of spastic hemiparetic patients.

Eligibility Criteria:
Inclusion Criteria:

* involve patients who have spasticity grade 1, 1 + and 2 of the gastrocnemius muscle, which ambulate with or without assistance devices, patients who tolerate the stimulus and have preserved cognition.

Exclusion Criteria:

* involve patients who have severe shortening, joint stiffness, cognitive deficits and patients with hypersensitivity.
Genotypic and Phenotypic Correlates of Resistance to Aspirin

The study seeks to identify genomic markers associated with aspirin resistance.

Not desired

Eligibility Criteria:
Inclusion Criteria:

* Volunteers 40 to 80 years old willing to sign consent and take 81 mg of aspirin for 7 - 10 days and return for laboratory testing.

Exclusion Criteria:

* Patient requiring more than 81 mg aspirin daily
* Known GI bleeding attributed to ASA
* Active peptic ulcer disease or history within the last year
* Known aspirin allergy
* Current use of:

  * warfarin,
  * heparin,
  * NSAIDs (except aspirin),
  * clopidogrel,
  * dipyridamole,
  * fish-oil/omega 3 supplements,
* Women of childbearing potential who are pregnant, planning to become pregnant or nursing.
Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial

Exercise during chemotherapy (CT) is a promising strategy to reduce fatigue and improve health-related quality of life (HRQoL). Exercise may also have beneficial effects on tumor outcome by decreasing insulin resistance, inflammation, and by modulating various pro-tumoral signalling pathways. It has been shown to reduce mortality in breast and colorectal cancer adjuvant setting.

This study aims to explore the effects of adapted physical activity (APA) in patients with resected pancreatic ductal adenocarcinoma (PDAC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven PDAC
* Complete macroscopic resection (R0 or R1 resection)
* Patients randomized within 12 weeks of surgery
* No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs
* Sufficient recovery from the operation and fit to take part in the trial
* Able to attend for administration of the adjuvant CT
* ECOG PS 0-2
* Age ≥ 18 years
* Life expectancy \> 3 months
* Dated and signed informed consent
* Registration in a national health care system (CMU included).

Exclusion Criteria:

* Macroscopically remaining tumor (R2 resection or TNM stage IV disease)
* Histology other than PDAC
* Cardiovascular, respiratory, psychiatric, musculoskeletal, or neurological condition contra-indicating exercise practice
* Pregnancy or breastfeeding
* Protected adults (individuals under guardianship by court order). Note: participation to another concomitant clinical trial is allowed but the patient must inform and get an authorization from the Investigator.
Optical Coherence Tomography - Guided Protocol for Left Main Percutaneous Coronary Intervention

LEMON aim is to evaluate the feasibility, efficiency and security of a standardized Optical Coherence Tomography (OCT) - guided protocol for completion and optimization of Left Main (LM) Percutaneous Coronary Intervention (PCI).

The LEMON study (LEft Main Oct-guided iNterventions) is a prospective, multicentre, open-label, interventional , non-randomized trial that investigates the feasibility and efficiency of OCT guidance for left main PCI in 10 active French interventional cardiology centres. The aim of the study is the appliance of a pre-defined standardized protocol for LM PCI . The LM PCI strategy is guided by 3 OCT runs, according to a pre-determined protocol. The first OCT run (run1) is performed before any stent implantation, the second run (run2) is performed after the stent is implanted, POT (proximal optimization technique) is applied and side branch iss rewired through stent struts. The third run (run3) is performed after PCI optimization. In case of additional stent optimization, a supplementary OCT run is applied in order to assess final result.

Eligibility Criteria:
Inclusion Criteria:

* age \>18
* stable or non-stable distal Left Main lesion (with or without previous Coronary Artery Bypass Graft), involving or not Left Anterior Descending and Coronary Circumflex ostias and requiring Percutaneous Coronary Intervention with a one or two stents strategy
* stable or non-stable ostial Left Anterior Descending and/or Coronary Circumflex lesion requiring Percutaneous Coronary Intervention with involvement of distal Left Main
* SYNTAX angiographic score \<23
* informed consent

Exclusion Criteria:

* ostial Left Main lesion
* on-going acute STEMI
* on-going cardiogenic shock
* severe chronic renal failure (Cr Cl \<30 ml/min/m2)
* anticipated technical contra-indication to OCT (highly calcified lesions, severe proximal tortuosity)
Lifestyle Modification and Potato Consumption

The investigators hypothesize that consumption of potatoes is a healthy adjunct to lifestyle intervention in overweight and obese glucose intolerant adults. We will evaluate the effects of the consumption of potatoes (high or low resistant starch) vs. commonly consumed carbohydrate sources on glucose tolerance; and ( the extent to which potato consumption alters markers of lipid metabolism and inflammation in the context of a lifestyle intervention program.

Our primary objective is to compare the effects of potato consumption to those of commonly consumed carbohydrate sources on glucose tolerance and other cardiometabolic risk factors in overweight and obese, glucose intolerant men and women participating in a lifestyle intervention program. We hypothesize that consumption of potatoes is a healthy adjunct to lifestyle intervention in overweight and obese glucose intolerant adults. Our specific aims include: (1) to evaluate of the effects of the consumption of potatoes (high or low resistant starch) vs. commonly consumed carbohydrate sources on glucose tolerance; and (2) to determine the extent to which potato consumption alters markers of lipid metabolism and inflammation in the context of a lifestyle intervention program.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between 20-65 years of age.
* Overweight or obese (BMI 25 - 39.9 Kg/m2)
* Impaired Glucose Tolerance: fasting glucose between 100-125 mg/dL
* Willingness to comply with the demands of the experimental protocol
* Sedentary lifestyle

Exclusion Criteria

* Major medical condition
* Smokers
* Unable to perform moderate exercise
* Use of medications that alter glucose or lipid metabolism
* Pregnant or lactating
Economic Analysis of Robotic Rectal Resection in German Health Care System

Analysis of cost effectiveness of robotic rectal resection, either sphincter preserving or abdominoperineal extirpation, in the German diagnosis related groups (DRG) system.

Robotic surgery has many well-known benefits for patients and surgeons, while it comes with higher acquisition and maintenance costs. On the other hand, a higher proportion of minimally invasive procedures can save costs by reducing complications, decreasing hospital stays due to lower morbidity, and saving personnel.

To what extent can robotic surgery be cost-covering or even profitable, depending on the postoperative course? This question is investigated under the conditions of the German DRG system.

Eligibility Criteria:
Inclusion Criteria:

* 18y
* histologically proven rectal cancer with curative therapeutic approach
* suitable for minimally-invasive surgery

Exclusion Criteria:

* no rectal cancer
* primary open surgery