cyrilzakka/clinical-trials huggingface dataset:
Minimal Invasive TLIF Arthrodesis Using Augmented Reality Navigation for Percutaneous Pedicle Aiming

Surgery for degenerative spondylolisthesis requires decompression of the narrow lumbar canal and fixation by osteosynthesis-arthrodesis. Conventional surgery is done through the open route. For 10-15 years, minimally invasive techniques have been established, allowing faster postoperative recovery for the patient. The downside to these techniques is the use of intraoperative fluoroscopy. This is why surgical navigation systems have been developed, allowing safe positioning of implants (pedicle screws). A new process (augmented reality navigation) has been tested in vitro and applied in open surgery. The HUS were the first establishment to apply this new method in minimally invasive surgery in a hybrid room of surgery and interventional radiology.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Subject operated at the HUS between March and December 2019
* Subject with a surgical indication for arthrodesis and decompression of the lumbar canal for degenerative spondylolisthesis L3-L4 or L4-L5
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice
Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic

Our multicenter observational study is a non-profit prospective study. The study was born from the Amplitude Project, which comprise the SOD of Minimally Invasive Robotic Urological Surgery and Renal Transplants of AOU Careggi with the University of Florence, as well as with the National Research Council (CNR) and the University of Milan Bicocca (UNIMIB) The study consists of a phase of enrollment of patients who will be admitted to the SOD of Mini Invasive Robotic Urological Surgery and Renal Transplantation of AOU Careggi. Enrollment in the study does not alter normal clinical practice and does not involve additional risks for patients. Patients will have to meet the inclusion and exclusion criteria of the study and will be enrolled sequentially, until the established sample size is reached. Patients undergoing surgery for the removal of bladder neoplasm, be it endoscopic or surgical with radical intent (cystectomy), will be taken a fragment of tumor bladder tissue, on which histopathological analysis will be performed. In patients undergoing radical cystectomy only, a fragment of healthy urothelial tissue, free from neoplasia, will also be removed. The samples will be performed in patients under general and / or spinal anesthesia in case of TURB, thus not causing pain or discomfort to the patient, or ex-vivo on the operative piece in case of radical cystectomy, without causing further damage or pain to the patient. From these samples, specially stored in solutions that keep their characteristics unaltered, a 3D culture model (organoid) will be obtained both from cells obtained from bladder cancer and from healthy tissue on which biomolecular, metabolomic and spectroscopic characterization studies will be tested and carried out. with a view to staging and grading bladder neoplasia.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Bladder Cancer diagnosis
* Capability to express informed consent

Exclusion Criteria:

* Age under 18
* Pregnancy
* Lack of informed consent
* Inability to provide informed consent
Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia

Validate pulse oximeter sensor SpO2 accuracy from 70-100% during induced hypoxia.

The testing is conducted on 10 healthy, consenting, non-smoking subjects in accordance with the IRB approved Protocol. The subjects shall be distributed across both genders and a range of skin tones as equally as practical.

An arterial line will be placed in the radial artery of each subject's right arm, and sensors will be attached to each subject. The subjects will be placed in a semi-supine position and allowed to breathe through a mouthpiece while the nose is blocked with a nose-clip.

Hypoxia will be induced by on each subject, as levels of oxyhemoglobin saturation (between 70% and 100%) are achieved by breathing mixtures of nitrogen, room air and carbon dioxide. Inspired O2 concentration will be adjusted breath-by-breath using a computed saturation, based on end-tidal PO2 and PCO2, as sampled by a mass spectrometer. Predicted levels of oxyhemoglobin saturations will be attained and held stable. At a minimum of sixty seconds into each plateau, a 0.5cc waste blood draw through the arterial line, followed by the first 1.0cc sample blood draw. After approximately thirty additional seconds, the second 1.0cc sample blood draw will be taken. The samples will immediately be analyzed by a Radiometer OSM-3 multi-wavelength co-oximeter and recorded. The SpO2 data from the oximeters will be collected via a laptop computer. Concurrent with the end of each blood draw, a marker will be generated on the laptop computers to identify the event.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoker
* 18 years or older
* Meet the requirements of the investigator's medical history questionnaire criteria which described family history, present symptoms, smoking history, risk factors, nutrition, exercise levels and stress levels
* Understand and provide signed consent for the procedure

Exclusion Criteria:

* Smoker
* User of illegal drugs
* Hypertension
* Respiratory disease
* Known allergy to Lidocaine or its derivatives
* Those suffering from upper respiratory infection on the day of study
A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

A multicenter, open label study of Nilotinib in CML patients PH + with imatininb resistant in blast crisis, accelerated phase or chronic phase. The main purpose is evaluate the safety and efficacy of Nilotinib.


Eligibility Criteria:
Inclusion Criteria:

Stratum 1:

1. Currently participating in Novartis study CAMN107A2109
2. Written signed and dated informed consent prior to any study procedures being performed

Stratum 2:

1. Male or female
2. \> 18 years
3. ECOG 0,1,2
4. ASL/ALT \<= 2.5 ULN or \<= 5.0 ULN
5. Alcaline Phosfatase \<= 2.5 ULN
6. Serum Bilirrubin \<= 1.5 ULN
7. Serum Creatinine \<= 1.5 ULN or creatinine clearance \>=50 ml/min / 24 hours
8. Serum Lipase \<= 1.5 ULN

Exclusion Criteria:

Stratum 1 and stratum 2:

1. Reduction of the cardiac function
2. Use of Coumadin
3. Other severe medical concurrent conditions
4. Treatment with medications that prolonged the QT interval.
5. Mayor surgery 15 days before the inclusion in the protocol
6. Pregnant women or lactation

Other protocol-defined inclusion/exclusion criteria may apply
Low Dose Weekly Docetaxel Versus Pemetrexed in Previously Treated Advanced Non-Small-Cell Lung Cancer

Docetaxel and pemetrexed have been validated for previously treated advanced non-small cell lung cancer (NSCLC); however, tolerability is a concern with the docetaxel (tri-weekly 75 mg/m2 schedule). The investigators conducted this study to compare the efficacy and toxicity of weekly low-dose docetaxel versus tri-weekly pemetrexed for previously treated advanced NSCLC.

We have been following a schedule of weekly low dose docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks; 60 mg/m2 accumulated dose for each cycle) at our hospital in an effort to achieve better tolerability. We therefore performed an exploratory study, by statistical analyses, to investigate the efficacy and toxicity of such a low dose docetaxel schedule compared to that of pemetrexed in patients with NSCLC who have failed previous chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* stage IIIb or IV NSCLC
* previous treatment with chemotherapy or tyrosin kinase inhibitor
* performance status less than 2

Exclusion Criteria:

* age less 18 years
* pregnancy
* performance status 3-4
Evaluation of the Use of a Method "Radiomics" for DOPA PET in Gliomas

: The evaluation of gliomas in imaging represents a real challenge today, at the initial diagnosis, for therapeutic planning or follow-up treatment of these lesions. There is an urgent need for non-invasive imaging tools to evaluate a glioma throughout its management. At present, the diagnosis of certainty is only obtained through an anatomo-pathological analysis with sampling during an invasive procedure (surgery or biopsy). Magnetic resonance imaging, through perfusion, diffusion imaging or spectroscopy is developing in gliomas. However, it remains time-consuming and is not always available. At the same time, positron emission tomography (PET) with amino acids is an interesting alternative for these brain tumours. Amino acid PET has the advantage of being more specific than the abnormalities detected in MRI and the amino acid radiotracers cross the blood-brain barrier, even if not broken, unlike Gadolinium in MRI. Among these radiotracers, 18F-FDOPA can, among other things, assist in the non-invasive staging of gliomas at initial diagnosis


Eligibility Criteria:
Inclusion Criteria:

* Patient having performed a PET/CT examination at 18F-FDOPA for his glioma in the nuclear medicine department of the CHRU de Brabois for which the raw data are available;
* Person who received full information on the organization of the research and did not object to the use of these data;
* Patients affiliated to a social security scheme

Exclusion Criteria:

Person who received full information on the organization of the research and who objected to the use of the data

* Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice).
* A person of full age who is unable to give consent and who is not subject to a legal protection measure.
Hydrolyzed Collagen Combined With Djulis and Green Caviar Improve Skin Condition

Collagen combined with djulis and green caviar improve skin condition

Using collagen drinks combined fish collagen with djulis, and green caviar to improve skin condition.

Eligibility Criteria:
Inclusion Criteria:

1. Dry skin
2. Rough skin
3. Large pores
4. Dark yellow complexion
5. Sagging skin

Exclusion Criteria:

1. Skin disorders
2. Liver diseases
3. Kidney diseases
4. Allergy to cosmetics, drugs, or foods
5. Pregnant and lactating women
6. People who had any cosmetic procedures before 4 weeks of the study
7. Area of facial spot over 3 cm2
8. Vegan
9. People who took collagen supplements in the past 3 months.
Gingival Phenotype Prevalence of Lower Incisors and Associated Risk Factors : a Cross-sectional Study

Several types of gingival phenotype can be diagnosed in the general population and their evaluation is an essential clinical criterion in periodontal practice, whether the periodontal therapies are preventive or curative, non-surgical or surgical. Moreover, several authors have shown that the gingival phenotype varies from one dental sector to another, hence the interest of a meticulous and targeted diagnostic approach in relation to the established therapeutic objectives. To date, the gingival phenotype has been not studied extensively in the mandibular incisal area. Therefore, it seems relevant to conduct an observational cross-sectional study on a cohort of patients in good general health and with a healthy and intact periodontium to assess the prevalence of the gingival phenotype in this area. The secondary objective is to highlight the associated intrinsic and extrinsic risk factors for thin gingival phenotype, to anticipate a risk of gingival recession and to propose an early personal therapy.


Eligibility Criteria:
Inclusion Criteria:

* age (18 years old or older)
* dental student on the university hospital of Nice
* social security affiliate
* systemically healthy
* healthy and intact periodontium
* informed consent.

Exclusion Criteria:

* pregnancy
* under any regular medical treatment
* active periodontal disease
* presence of plaque
* enduring orthodontic treatment
* periodontal surgery in the mandibulary anterior region
* non consent patient
* patient under judgment trials.
Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer.

The aim is to develop radiogenomics models to stratify patients into three main risk categories (Favorable, Intermediate, and Unfavorable) according to the ProMisE model (9) and use these models to predict the most prognostically relevant EC histopathological features (i.e. FIGO stage, degree of tumor differentiation, histotype, LVSI status, myometrial and cervical invasion, lymph node metastases).

These models would support clinicians in personalizing surgical and adjuvant treatment choice among the options considered by the international guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of primary endometrial cancer (endometrioid, clear cell, serous, mixed, any grade)
* FIGO stage IA-IB
* Formalin-fixed, paraffin-embedded (FFPE) tissue at the diagnosis available - Availability of preoperative MRI scans in dicom (.dcm) format
* Availability of preoperative US images in dicom (.dcm) format
* Availability of preoperative CT-scan images in dicom (.dcm) format (optional)
* Available clinical information (e.g. baseline information, surgery, adjuvant therapy, median follow up period 24 months)

Exclusion Criteria:

* Metastatic cancer to the uterus (not primary EC)
* Uterine sarcoma
* Conservative surgery
* FIGO stage \> II
* Formalin-fixed, paraffin-embedded (FFPE) tissue at the diagnosis not available
* Patients without available MRI, US or CT-scan images on digital media
* Clinical information not available or incomplete
* Any other malignancy in the previous 5 years or synchronous
* Patients aged under 18 years
Safety and Effect of Biphasic Insulin Aspart 50 in Patients With Type 2 Diabetes Mellitus.

This trial is conducted in Japan. The purpose of this trial is to investigate the safety and the effect of biphasic insulin aspart 50 compared to biphasic human insulin 50 in patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Current treatment with pre-mixed human insulin preparation or biphasic/pre-mixed insulin analogue in twice daily treatment for at least 8 weeks.
* HbA1C: less than 11.0%
* BMI: less than 30.0 kg/m2

Exclusion Criteria:

* Total daily insulin dose: 100 IU/U and more
* Treatment with oral hypoglycaemic agents within the last 4 weeks.
* Treatment with insulin sensitizer within the last 12 weeks
* A lifestyle that is considered unsuitable for this trial (frequent or routine night shift workers etc.)
Effects of Recruitment Manouever on Oxygenation, Oxygen Reserve Index and Postoperative Pulmonary Complications

General anesthesia and mechanical ventilation decrease pulmonar volume; attenuate small airway closure, atelectasis, and increase the rate of hypoxia and postoperative pulmonary complications. Lung volume in obese patients decreases inversely with the increase in body mass index. Obesity is associated with increased atelectasis, hypoxia and postoperative pulmonary complication rates during anesthesia . Alveolar recruitment maneuver is a technique where high positive end-expiratory pressure (PEEP) is applied for for short periods, follwed by a continuous PEEP appşication throughout surgery. This has become a standard practice during anesthesia in recent years. Oxygen reserve index (ORi) is an index measured with a non-invasive finger-tip sensor and shows the oxygen content of the venous blood. It is effective at high oxygen levels and may indicate the presence of hyperoxia. Our aim is to examine the effect of alveolar recruitment maneuver on oxygenation parameters under anesthesia and the correlation with ORi in morbidly obese patients.

Patients with body mass index\> 40 m2, scheduled for bariatric surgery under general anesthesia will be monitorised with the ORi sensor and monitored at regular intervals. Preoperative and postoperative lung aeration will be evaluated with lung ultrasaund. İntraoperative standart anesthesia will be administered by an anesthesiolıgist not aware of the ultrasound. Alveolar recruitment will be applied by the same anesthesiologist if necessary. Blood gas samples obtained throughout surgery will be evaluated. ORİ values and intraoperative vital, respiratory, neuromuscular monitoring parameters will be obtained. Postoperative pulmonary complicationsa will be evaluated at postoperative day 5.

Finding will be compared between patients who received recruitment and who did not.

Eligibility Criteria:
Inclusion Criteria:

Bariatric surgery general anesthesia and mechanical ventilation via orotracheal entubation Age between 18-65 ASA I-III BMI \> 40 m-2

Exclusion Criteria:

Previous history of thorasic surgery, pneumothorax Chemo or Radiotherapy to the chest within 2 months History of Respiratory disease (COPD, emphysema, pneumonia, lung malignancy, Lung Bulla ) Emergency surgery Cardiovascular, renal, hepatic, neuromuscular disease İntracrabial pathology or trauma High intraoptic pressure Pulmonary Hypertension Pregnancy Criticall illness, or history of mechanical ventilation within 1 month
Impact of Omalizumab on Corticosteroid Use, Emergency Room Visits and Hospitalizations

A retrospective database analysis to evaluate the impact of omalizumab on the use of corticosteroid, emergency-department visits and hospitalizations among patients with uncontrolled asthma and using high-dose Inhaled Corticosteroids (ICS) prior to initiating omalizumab.


Eligibility Criteria:
Inclusion Criteria:

* ≥12 years of age with a documented Cystic fibrosis (CF) diagnosis,
* on Long acting Beta antagonist- Inhaled Corticosteroid (LABA-ICS) at baseline,
* uncontrolled asthma at baseline.

Exclusion Criteria:

Other protocol-defined inclusion/exclusion criteria may apply.
Optimization of Cardiac-MR Protocols

The aim of the present study is the optimization of various magnetic resonance (MR) investigation protocols of the heart and the lung without contrast agent application as well as the generation of normal values from cardiac MR images. One of the main problems in cardiac MR investigations is the strong dependence of the achieved image quality on optimal settings of sequence parameters and anatomical and physiological situations with special emphasis on phase-contrast imaging and other cine-techniques.

Time optimized and well organized MR protocols for the cardiac and lung investigations are evaluated on normal subjects with special respect to following topics:

1. Localization: Definition of standardized anatomic imaging planes with special respect to the right ventricle.
2. Morphological imaging: Optimization of spin-echo and gradient-echo sequences for various heart frequencies and breath-hold abilities. Investigation of the effect of various preparation pulses. Optimization of the signal-to-noise ratio for morphological cardiac imaging. Evaluation and optimization of various breathing and breath-hold (with and without navigator) ECG and pulse triggered sequences.
3. Cardiac and lung function: Optimization of gradient-echo sequences for various heart frequencies and breath-hold abilities. Evaluation of pulse-triggered function analysis and optimization of free breathing protocols. Optimization of tagging techniques. Evaluation of the pulsatile flow in lung vessels. Acquisition of age depended normal data of cardiac and lung function.
4. Coronary imaging: Definition of standardized anatomic imaging planes to monitor coronary arteries (single oblique, volume targeted). Optimization of acquisition window with respect to various heart frequencies. Evaluation of the influence of the position of the navigator and tracking factor on image quality. Optimization of a pulse triggered protocol. Evaluation of black-blood coronary imaging and visualization of the lumen and wall of coronary arteries.
5. Phase contrast techniques: Optimization of imaging planes, time resolution and spatial resolution of flow measurements in the heart, in the vessels around the heart, lung vessels and coronary arteries. Evaluation of retrospective and prospective gating with respect to the heart frequency. Evaluation of normal values in 1-dimensional, 2-dimensional and 3-dimensional time resolved flow measurements.
6. Single-Shot Imaging: Evaluation of signal intensity and stability of single shot techniques with and without preparation pulses. Optimization of real-time image acquisition.
7. Parallel acquisition and breath-hold time optimization: Evaluation of impact of echo-sharing and parallel acquisition on image quality. Optimization of short-breath-hold protocols.

Eligibility Criteria:
Inclusion Criteria:

* No history of cardiac or pulmonary diseases

Exclusion Criteria:

* MRI exclusion criteria
Effect of PRM-125 on Ambulatory Blood Pressure

Evaluation of Once-Daily PRM125 On Ambulatory Blood Pressure in Adults with Hypertension

Approximately 60 subjects with primary hypertension are treated for 8 weeks with PRM125 to determine if Ambulatory Blood Pressure is changed.

Eligibility Criteria:
Inclusion Criteria:

* primary hypertension

Exclusion Criteria:

* medical conditions that preclude evaluation and/or adversely effect subject safety
Melatonin Plus Aminoacids for Sarcopenic Elderly

To evaluate the effectiveness of melatonin and essential aminoacid supplementation on body composition, protein metabolism, strength and inflammation. The investigators performed a Randomized controlled parallel groups preliminary trial in 159 elderly sarcopenic people (42/117 men/women) assigned to 4 groups: isocaloric placebo (P, n=44), melatonin (M, 1 mg/daily, n=42,), essential aminoacids (eAA 4 g/daily, n=40) or eAA plus melatonin (eAAM, 4 g eAA and 1 mg melatonin/daily, n= 30). The period of intervention was 4 weeks. Data from body composition (DXA), strength (handgrip test) and biochemical parameters for the assessment of protein metabolism (albumin) and inflammation (PRC) were collected at baseline and after the 4-week intervention


Eligibility Criteria:
Inclusion Criteria:

* Aged \> or equal 65 years
* Sarcopenic patients, following the Rosetta Study criteria: Skeletal Muscle Index \[SMI\] was \<7.23 kg/m2 in men and \<5.45 kg/m2 in women) and loss of strength, evaluated by dynamometer and defined as \<30 kg for men and \<20 kg for women, using the average value of the two handgrip measurements of the dominant hand.

Exclusion Criteria:

* acute illnesses
* severe liver dysfunction
* severe heart dysfunction
* severe kidney dysfunction
* severe dementia
* uncontrolled diabetes
* dysthyroidism
* any endocrinopathies
* neoplasia
* patients treated with steroids
* patients entirely unable to walk