cyrilzakka/clinical-trials huggingface dataset:
A Prospective Randomized Study Comparing Sentinel Lymph Node (SLN) Evaluation With Standard Pathological Evaluation for the Staging of Colon Carcinoma

The objective of this trial is to define the rate of upstaging of colon carcinoma lymph node metastasis with sentinel lymph node (SLN) mapping.

Null hypothesis: There is no difference in the rate of lymph node metastasis between conventional histopathological processing of lymph nodes and SLN mapping with detailed pathologic examination using immunohistochemistry (IHC) in patients undergoing resection of colon carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age
2. Primary, non-metastatic \[Stage I, II (localized, node negative), or III (localized, node positive)\] colon carcinoma confirmed by tissue biopsy or colon mass clinically consistent with cancer and eventually confirmed by pathology
3. Palpable mass at time of surgery
4. Capable of providing informed consent

Exclusion Criteria:

1. Prior radiation or chemotherapy
2. Non-palpable colon tumor
3. Recurrent or Stage IV (metastatic) colon cancer
4. Unable to give informed consent
UltraShape Power in Combination With U-sculpt-n Transducer

Prospective, open label, self - controlled, single arm, clinical study to assess the performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for circumference reduction versus self-control.


Eligibility Criteria:
Inclusion Criteria:

1. Subject ≥18 and ≤60 years of age at the time of enrollment
2. Fat thickness of at least 1.5 cm in the outer thigh and/or flank (measured by calibrated caliper)
3. For women of child-bearing potential: negative urine pregnancy test
4. General good health confirmed by medical history and skin examination of the treated area
5. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.

Exclusion Criteria:

1. History of un-balanced hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator
2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
3. Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone
4. Previous liposuction in the treatment areas within 12 months
5. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
6. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
7. Childbirth within the last 12 months or women who are breastfeeding a child
Comparison of Hemi-shoulder Arthroplasty and PHILOS in Treating Three or Four-part Fractures of Proximal Humerus

To explore clinical effectiveness of PHILOS plate fixation and hemi-shoulder arthroplasty in treating three or four-part fractures of proximal humerus

From April 2015 and April 2017, patients from multi-center aged over 60 years old with three and four-part fractures of proximal humerus were treated with Proximal Humerus Internal Locking System(PHILOS) and hemi-shoulder arthroplasty in multi-center. All the patients received the same rehabilitation course. At 6 months after surgery, postoperative complications were observed, EQ-5D was used to evaluate quality of life, and ASES score was used to assess functional outcomes.

Eligibility Criteria:
Inclusion Criteria:

three or four part fractures of proximal humerus

Exclusion Criteria:

1. Severe comminuted fractures of proximal humerus
2. past history of injured-side shoulder surgery
3. Patients who cannot tolerate surgery
Efficacity Study With the Protégé EverFlex Stent in Popliteal Lesions

This study will assess the results up to 12 months with the Protégé EverFlex stent (ev3) in patients presenting with a narrowing or blocking at the level of the knee artery, which leads to a limited walking distance, rest pain or non-healing ulcers.


Eligibility Criteria:
Inclusion Criteria:

General Inclusion criteria

* De novo, restenotic or reoccluded lesion located in the popliteal artery, with or without superficial femoral artery involvement
* Patient presenting a score from 2 to 5 following Rutherford classification
* Patient is willing to comply with specified follow-up evaluations at the specified times
* Patient is \>18 years old
* Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
* Prior to enrollment, the guidewire has crossed target lesion
* Patient is eligible for treatment with the self-expanding nitinol EverFlex (ev3) stent

Angiographic Inclusion Criteria

* The target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion which can be passed with standard guidewire manipulation
* The target lesion, visually estimated, has a maximal length of 14 cm and can be categorized as either a type A or B lesions according the TASC II guidelines
* Target vessel diameter visually estimated is \>3.5mm and \<7.5 mm
* There is angiographic evidence of at least one-vessel-runoff to the foot

Exclusion Criteria:

* Presence of another stent in the target vessel that was placed during a previous procedure
* Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
* Previous by-pass surgery in the same limb
* Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
* Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
* Perforation at the angioplasty site evidenced by extravasation of contrast medium
* Patients with known hypersensitivity to nickel-titanium
* Patients with uncorrected bleeding disorders
* Aneurysm located at the level of the SFA and/or popliteal artery
* Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
* Life expectancy of less than twelve months
* Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis \> 30% or ipsilateral iliac treatment conducted after the target lesion procedure
* Use of thrombectomy, artherectomy or laser devices during procedure
* Any patient considered to be hemodynamically unstable at onset of procedure
* Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
Comparison of Automatic CPAP to Fixed CPAP for OSAS Following a Prediction Formula

Comparison of automatic CPAP with fixed CPAP in patients with OSAS

The polysomnography is divided into two parts, randomly assigned:

* in one part, the patient uses the automatic CPAP device in titration mode
* in the other part, the patient uses the CPAP device, in fixed mode according to the prediction formula

Eligibility Criteria:
Inclusion Criteria:

* Patients with proven Obstructive Sleep Apnea Syndrome
* Apnea-hypopnea-index \> 20/h
* Awaking index \> 30/h

Exclusion Criteria:

* Severe nasal obstruction
* Hypoventilation
* Excessive sleep fragmentation caused by non-respiratory factors
* COPD (FEV1/FVC \< 65%)
* CPAP compliance \< 3h per night
* Insufficient sleep time (\< 2h TST) during one of both parts of the split night CPAP-titration
* Patients needing \> 16 mbar CPAP pressures
Study to Assess the Safety and Efficacy of Infliximab to Treat Hidradenitis Suppurtativa

A study to assess the safety and efficacy of the IV drug infliximab for the treatment of hidradenitis suppurativa


Eligibility Criteria:
Inclusion Criteria:

* Person must have moderate to severe Hidradenitis suppurativa
* Multiple ER or doctors visits related to HS
* Intralesional kenalog injection \>5/year, but none within 3 months of entry
* HS \>1 year duration
* Failed systemic retinoids, but not within 3 months of entry
* Failed at least one prior course of antibiotic therapy, which must not have been administered within 3 months of entry to the study (excluding the recommended antibiotic regimen given immediately before randomization for evidence of active infection
* History of surgery (reconstructive), but not within 3 months of entry

Exclusion Criteria:

* Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion (this includes father's who plan on fathering a child within 6 months after their last infusion
* Known allergy against infliximab
* Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent).
* Have had any previous treatment with monoclonal antibodies or antibody fragments.
* Have a known history of serious infections (eg, hepatitis, pneumonia or pyelonephritis) in the previous 3 months.
* Have or have had an opportunistic infection (eg, herpes zoster \[shingles\], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
* Are considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules defined in Section 26 on: Tuberculosis Eligibility Assessment, Screening, and Early Detection of Reactivation Rules.
* Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly.
* Currently have any known malignancy or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence.
* Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
The Electroretinogram in Healthy and Glucose Intolerant Young Men

The purpose is to investigate the electroretinogram (ERG) in young, healthy men in the normoglycaemic and hyperglycaemic state before and after intervention with corticosteroids treatment, high calorie diet and exercise restraint.

The subjects will be fasting from midnight the day before the experiment. Standard procedures (including pupil dilation, dark adaptation, and local anaesthetics) are carried out to allow the ERG to be obtained. After electrophysiology, the subject will be clamped at a plasma glucose level of 10 mM (\~180 mg/dL) and after a stabilisation period the ERG protocol is repeated.

Each subject is examined twice on two different days. The first day the subjects are normoglycaemic in the morning (first examination) and hyperglycaemic (clamped to 10 mM) throughout the second examination. The second day subjects are also normoglycaemic and hyperglycaemic but shows up after 7-12 days of daily intake of prednisolone, high calorie diet, and exercise restraint.

Eligibility Criteria:
Inclusion Criteria:

* Caucasians without type 2 diabetes mellitus
* Normal OGTT (75 g glucose dissolved in 250 mL water) according to WHO's criteria
* BMI 20-30
* Haemoglobin \> 8,0 mM

Exclusion Criteria:

* Nephropathy (s-creatinin \> 130 µM or albuminuria)
* Relatives (parents or sibling with T2DM)
* Medical treatment which cannot be paused for 12 hours
Effects of Upper Extremity Low Volume HIIT in Heart Failure

This study was planned to investigate the effects of upper extremity low-volume high-intensity interval training (LV-HIIT) on physical and cognitive function in patients with heart failure with preserved ejection fraction(HFpEF).The research was planned as a randomized controlled trial. Patients with clinically stable HFpEF at cardiology clinic will be included in the study. These cases will be randomly divided into two groups: intervention group and control grup. After 8 weeks intervention physical functions before and after treatment; functional exercise capacity, arm exercise capacities , peripheral muscle strength , fatigue cognitive functions; anxiety and depression and fear of movement will be evaluated.

Patients in the DV-HIIT group will receive training consisting of 4 minutes of warm-up and cool-down at 50% Wmax on an arm ergometer, 1 minute of training at 85-95% Wmax work intensity, followed by 6 interval training periods including 1 minute of active recovery periods at 50-70% Wmax, 2 days/week, totaling 8 weeks of training. The control group will be followed with standard medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical condition stable for ≥4 weeks.
* New York Heart Association functional classification I-II to III
* Over 18 years old

Exclusion Criteria:

History of CABG surgery

* Unstable angina pectoris
* Severe arrhythmia
* Acute pericarditis, endocarditis, myocarditis
* Severe left ventricular failure (EF \<40%)
* Acute pulmonary embolism
* History of syncope
* Dissecting aneurysm
* Thrombophlebitis
* Orthopedic disorders that may interfere with exercise
* Uncontrolled hypertension, severe pulmonary arterial hypertension
* Moderate-severe valve disease
* Decompensated Congestive Heart Failure
* Electrolyte abnormalities
* Hypertrophic Cardiomyopathy
EVALUER L'IMPACT PREDICTIF DU SCORE MEESSI POUR LA STRATIFICATION DU RISQUE DES PATIENTS ADMIS POUR INSUFFISANCE CARDIAQUE AIGUE DANS LES STRUCTURES D'URGENCES

Our primary purpose is to assess MEESSI score in predicting mortality and readmission of patients managed for acute heart failure (AHF) in Emergency Department.

European Society of Cardiology recommend risk stratification for patients with AHF. MEESSI score is not prospectively validated out of Spain.


Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Patient admitted to emergencies with suspicion of ICA according to the clinical intuition of the emergency doctor after interrogation, clinical examination, biology and imaging
* Patient with health insurance
* Subject who accept to participate in the research

Exclusion Criteria:

* Patient who refuse to participate in the study
* Patient with coronary syndrome with ST segment elevation
* Other diagnosis of dyspnea
* Persons deprived of their freedom or under the protection of justice
* Persons under guardianship or curatorship
* Impossibility of giving the patient informed information
* Pregnant woman
A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy

This is a Phase 2, double-blind, parallel-group, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of multiple doses of ONO-2808 in patients with MSA. This is the first study of ONO-2808 in patients with MSA.

The purpose of the study is to evaluate 3 doses of ONO-2808 compared to placebo in MSA patients, including: 1) safety and tolerability, 2) pharmacokinetics, and 3) changes in clinical outcome assessments (COA) and biomarkers considered to be related to the pharmacodynamics and potential efficacy of ONO-2808.

Eligibility Criteria:
Inclusion Criteria:

1. Female or male patients with a diagnosis of clinically-established or clinically-probable MSA according to the novel Movement Disorder Society (MDS) criteria for MSA diagnosis (2022), including patients with MSA of either subtype (MSA-P or MSA-C).
2. Patients at the early stages of the disease, defined as a maximum of 5 years since the onset of one of the following symptoms associated with MSA:

   * Parkinsonism
   * Ataxia
   * Orthostatic hypotension and/or urinary dysfunction
3. Patients with an anticipated survival of at least 3 years in the opinion of the Investigator.
4. Patients who are able to ambulate without the assistance of another person, defined as the ability to take at least 10 steps and then to turn around and walk at least another 10 steps. Use of assistive devices (e.g., walker or cane) is allowed.
5. Ability to swallow oral medication and be willing to adhere to the study intervention regimen.

Exclusion Criteria:

1. Pregnant or lactating females.
2. Patients with a clinically-significant or unstable medical or surgical condition other than MSA that, in the opinion of the Investigator, might preclude safe completion of the study or might affect the results of the study (e.g., pulmonary, cardiovascular \[including bradyarrhythmia\], macular edema, and significant renal or hepatic dysfunction).
3. Neurological diseases/disorders other than MSA, such as Parkinson's disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, normal pressure hydrocephalus, pharmacological, or post-encephalitic parkinsonism.
4. Patients with documented liver diseases or cirrhosis.
5. Positive results at Screening for active viral infections that include positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis B core antibody, and hepatitis C virus (HCV).
6. Patients with suicide ideation according to the Investigator's clinical judgment per the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening or who have made a suicide attempt in the 6 months before Screening.
Study of the Effect of Kinesio Taping and Proprioceptive Exercise on the Stability of Ankle in Amateur Soccer Players

Soccer is a sport that attracts many participants and leads to a substantial number of injuries, especially of the ankle. Enhancement of functional joint stability by kinesio taping proprioceptive training may be important both in prevention and rehabilitation of ankle injuries. The main aim of this study was to determine the effect of kinesio taping and proprioceptive exercises on parameters related to ankle stability, such as the injury incidence, pain, static or dynamic stability and flexibility, in amateur soccer players training 3 times a week.


Eligibility Criteria:
Inclusion Criteria:

* To be older than 18 years old.
* To be soccer player for more than 5 years.

Exclusion Criteria:

* Serious illness.
* Recent ankle injury
* Vestibulocerebellar disorder
* Allergy to Kinesio taping
* Inability to complete all interventional sessions for any reason
Genetic Factors and Pheochromocytomas in Neoplasia Type 2

Multiple endocrine neoplasia type 2A (MEN2A) is a rare syndrome associated with activating mutations in the RET proto-oncogene, combining medullary thyroid cancer in approximately 100% of cases and pheochromocytoma in 10-80% of cases. While it is accepted that the RET mutation causes variable penetrance of pheochromocytoma in the MEN2A patient population, there is no pathophysiological explanation for the phenotypic variability among patients with the same mutation, including within the same family. The aim of this study is to better characterise the genetic factors that may explain the variable penetrance of pheochromocytoma in MEN2. To this end, the investigatoes plan to perform a whole exome analysis in 2 families carrying the p. Cys634Arg mutation causing NEM2A, followed in Marseille by the principal investigator: the 1st family has 11 members all aged over 35 years, for which 8 are carriers of pheochromocytoma while 3 have not developed it (while their age is higher than the latest age of diagnosis of pheochromocytoma in this family); the 2nd family has 3 members (father and daughter with pheochromocytoma developed before 25 years; son without pheochromocytoma at an age of 42 years). The investigators believe that the analysis of these patients should allow the isolation of variants on genes potentially involved in the genesis of a pheochromocytoma in MEN2.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older
* Male or female patient
* Patient followed in the investigating department for familial NEM2A C634R (multiple endocrine neoplasia type 2) with or without pheochromocytoma
* Patient affiliated to or benefiting from a social security scheme
* Patient having given his non-opposition to participate in this study
* Patient who has given his consent for the genetic analysis carried out in the framework of the study
* Patient able to understand the purpose of the study

Exclusion Criteria:

* Protected persons (articles L1121-5, L1121-6 and L121-8 of the Public Health Code): pregnant or breastfeeding women, persons deprived of their liberty, under guardianship or curator
* Patients unable to understand the purpose of the study and the information note
A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C

The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent
2. Target population: Healthy males and females.
3. Males and females, ages 18 to 55 years, inclusive.
4. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test
5. Women must not be breastfeeding
6. Men and WOCBP must agree to follow instructions for contraception

Exclusion Criteria:

1. History of TB, malignancy, any other chronic or acute infecton or disease.
2. History of acute or chronic medical illness
3. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
4. History of allergy to belatacept or related compounds -
Study of Daraxonrasib (RMC-6236) in Previously Treated Patients With RAS Mutated NSCLC (RASolve 301)

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve progression free survival (PFS) or overall survival (OS) compared to docetaxel chemotherapy in patients with NSCLC who were previously treated. Patients will be randomized in a 1:1 ratio to receive daraxonrasib or docetaxel chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old and has provided informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Histologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.
* Measurable disease per RECIST v1.1.
* Adequate organ function (bone marrow, liver, kidney, coagulation).
* One to two prior lines of therapy including an anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy.
* Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
* Able to take oral medications.

Exclusion Criteria:

* Prior therapy with direct RAS-targeted therapy or docetaxel.
* Untreated central nervous system (CNS) metastases.
* Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function).
* Ongoing anticancer therapy.
* Pregnancy and/or breastfeeding.
Comparison of Simple Blood Lancet(Vitrex®)With DuoTip as Skin Prick Test Devices Among Mite-sensitized Subjects

The purpose of this study is to compare the results skin prick tests using simple blood lancet (Vitrex®) with DuoTips among mite-sensitized subjects.

We intend to compare results of skin prick tests by using simple blood lancet(Vitrex®) and DuoTips in terms of wheal size, variability, transfer of allergen and pain level, among mite-sensitive subjects.

Eligibility Criteria:
Inclusion Criteria:

* Who have positive skin prick testing to Der p 10,000 AU/ml (wheal size 3 mm at least)
* Age 12-60 yrs
* Written informed consent was obtained from all subjects and their parents

Exclusion Criteria:

* Who have positive skin prick testing to Der p 10,000 AU/ml above 15 mm.
* Who have dermographism
* Who have severe disease eg. severe respiratory disease or severe cardiovascular disease
* Who have severe eczema
* Who receive antihistamine, topical steroid within 7 days or ketotifen within 14 days or systemic steroid within 1 month
* Pregnant women