cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty

Evaluation of a new navigation system in computer-assisted total knee arthroplasty.

Single-blind, randomised, prospective comparative study in two parallel groups (conventional or computer-assisted arthroplasty).

The patient will be evaluated during 3 visits: inclusion D0 (before arthroplasty), M3 (intermediate visit 3 months after arthroplasty) and M12 (final visit 12 months after arthroplasty).

Eligibility Criteria:
Inclusion Criteria:

* Adult man or woman who has signed the informed consent for participation in the study,
* Patient with primary uni or bilateral gonarthrosis
* For whom an indication for total knee arthroplasty has been given

Exclusion Criteria:

* History of fracture, arthroplasty or osteotomy of the knee
* Severe preoperative laxity warranting a constrained prosthesis
* Inflammatory rheumatic disease or any other progressive concomitant condition that may impact on the patient's functional prognosis
* Traumatic articular or extra-articular deformities of the lower limb
* Neurological disease, after-effects of a stroke
* Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
* Patient not affiliated to the French social security system
* Patient under legal protection, guardianship or curatorship
* Patient already included in another therapeutic study protocol or having participated in another trial in the previous three months
A Study to Evaluate the Safety and Efficacy of COVID-19 Convalescent Plasma (CCP) Transfusion to Prevent COVID-19 in Adult Recipients Following Hematopoietic Stem Cell Transplantation

The study is to evaluate the safety and efficacy of COVID-19 convalescent plasma (CCP) transfusion to prevent COVID-19 in adult recipients following hematopoietic stem cell transplantation.

72 patients will be randomized in a 1:1 ratio to receive either CCR (36 patients) or not (36 patients). Patients in the CCP group will receive 200 ml of CCP at +14 days, +28 days, +2 months, and +3 months following hematopoietic stem cell transplantation. Patients in the control group would be routinely given oral ursodeoxycholic acid for +14 days after transplantation.

The primary goal of the study is to evaluate the safety of CCP and the incidence of COVID-19 infection within +28 days after the last infusion of CCP.


Eligibility Criteria:
Inclusion Criteria:

1. receive hematopoietic stem cell transplantation
2. Be ≥ 16 years of age on the day of enrollment.
3. Understand the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent.

Exclusion Criteria:

1. Positive serological response to known HIV or active hepatitis C virus.
2. Patients with mental illness or other conditions that do not meet the requirements of research treatment and monitoring.
3. Unable or unwilling to sign consent form.
4. Patients with other special conditions assessed as unqualified by the researchers.
5. Patients suffered COVID-19 infection between day 0 and infusion of CCP after transplantation.

Drop-out and Withdrawal Criteria

1. Failure of engraftment within 30 days of transplantation;
2. Patients who are not compliant with the requirements of the study and fail to follow the study plan.
3. Patients receiving prophylaxis for COVID-19 infection by methods other than this protocol during the trial.
4. A patient may withdraw from the study if he/she does not wish to continue participating in the study, and the date and reason for withdrawal shall be recorded. The investigator may also decide to discontinue a patient from the clinical study if there is an unacceptable risk.
Translation and Validation of the Turkish Version of the ObsQoR-11 Questionnaire

Ciechanowicz et al. developed and validated a postpartum recovery score for women with a caesarean section: the ObsQoR-11. The psychometric validation of the ObsQoR-11 confirms its reliability, its response to change, its acceptability and its feasibility. The use of this score allows the investigators to quantify the quality of the patient's recovery between 0 and 110, by allocating a score from 0 to 10 for each item. ObsQoR-11 has not yet been validated for use in Turkish. Therefore the investigators aimed to psychometrically evaluate the Turkish translated version of the ObsQoR-11 in a Turkish cohort of women.

Recovery after caesarean section is a complex process, depending on the characteristics of the patient and the anaesthesia. Scales for measuring the quality of post-operative recovery have been developed. Ciechanowicz et al. developed and validated a postpartum recovery score for women with a caesarean section: the ObsQoR-11. This multidimensional scale is a questionnaire of 11 items evaluating: moderate pain, severe pain, nausea and vomiting, feeling of discomfort, shivering, feeling of comfort, ability to mobilize, ability to carry the newborn, ability to feed, ability to groom alone, and finally feeling of self-control. The investigators aimed to validate the translated version of the Turkish ObsQoR-11 scale.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old)
* Turkish-speaking
* Admitted for cesarean section
* Able to answer the questionnaire, alone or with the help of a third party
* Agreeing to participate in the study

Exclusion Criteria:

* Psychiatric or neurological pathology
Symbolic Representation in Young Children With Down Syndrome

The aim of this study is to characterize the process of constitution of symbolic representation in infants with Down syndrome, as well as to investigate the relationship between gestures and the emergence of oral language. The investigators hypothesis is that children with Down syndrome could present difficulties during the constitution of symbolic representation that may be related to later deficits on expressive language, generally observed in these children.

According to the Genetic Epistemology, language development is directly related to cognitive construction. Such relationship is clearly observed after the constitution of representation that allows one individual to express his or her thinking through language.

Eligibility Criteria:
Inclusion Criteria for Study Group:

* genetic diagnosis of Down Syndrome
* be at the 4th stage of sensorimotor period at the initial assessment
* good health conditions
* good results on audiologic evaluation
* pediatric and ear, nose and throat periodic check ups.

Inclusion Criteria for Control Group:

* good health conditions
* be at the 4th stage of sensorimotor period at the initial assessment
* pediatric and ear, nose and throat periodic check ups.

Exclusion Criteria for all groups:

* submission to long term hospitalizations due to heart diseases and major respiratory airway infections, that may interfere in the child's global development
* presence of visual or auditory important deficits
* historic of prematurely and/or low birth weight
A Digital Non-interventional Atrial Fibrillation (AF) Screening Study With Commercial Pulse Detection Systems

The primary objective in this study is to identify commercial pulse detection systems (CPDS) parallel to electrocardiogram (ECG) recording within routine clinical setting, which are able to detect atrial fibrillation or sinus rhythm of screened patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult female and male patients for whom the decision to record an ECG was made as per investigator's routine treatment practice
* Patient able and willing to provide signed informed consent

Exclusion Criteria:

* Patients with any comorbidities or abnormalities of heart function or rhythm, which might, in the opinion of the investigator, interfere with the evaluation of study data
* Patients participating in an investigational program with interventions outside of routine clinical practice
An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis

Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.

This is an experimental medical research study. The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis.

Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 20, 22, 28, 36, 44 for 48 weeks

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA according to the American College of Rheumatology criteria for at least 3 months prior to screening
* Have active Rheumatoid Arthritis at the time of screening and at baseline, as defined by 6 or more swollen joints and 6 or more tender joints and additional laboratory criteria

Exclusion Criteria:

* Have other inflammatory diseases, including but not limited to ankylosing spondylitis, systemic lupus erythematosus, Lyme disease
* Received disease-modifying antirheumatic drugs (\[DMARDs\] eg, D penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, interleukin \[IL\]-1 receptor antagonist \[anakinra\], azathioprine, sulphasalazine, agents other than MTX) within 4 weeks prior to the first study dose
Idiopathic Esophagogastric Junction Outflow Obstruction

This study compares two treatments for Idiopathic Esophagogastric Junction Outflow Obstruction: pneumatic dilation compared with expectant management, on symptoms and liquid barium emptying exams.

The objectives of this study are to address these gaps in knowledge by:

Performing a randomized controlled trial in patients with idiopathic EGJOO that compares treatment outcomes after pneumatic dilation versus expectant management (disease controls) (expectant management). And, determining rational physiological and objective measures of treatment response.

Eligibility Criteria:
Inclusion Criteria:

* Initial HRIM consistent with the diagnosis of EGJOO and mechanical esophageal obstruction has been excluded by prior upper endoscopy.
* EGJOO patients with a retained liquid barium column on TBE ≥5cm in height at 1 minute
* Patients must have symptomatic dysphagia

Exclusion Criteria:

* Diseases that potentially could cause mechanical obstruction such as gastroesophageal reflux disease with erosive esophagitis, peptic stricture, cancer, eosinophilic esophagitis, prior fundoplication, adjustable gastric band surgery and hiatal hernias. Patients with any identifiable anatomic esophageal or gastric obstruction will be excluded from the study
* Patients with previous surgery on the esophagus or stomach
* Previous history of per oral endoscopic myotomy or prior pneumatic dilation
* History of gastroparesis
A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 12.5 mg and MET XR 500 mg) in Healthy Volunteers

This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after co-administration of ALO and MET XR or administration of CT-L01 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject aged 19 to 50 years, at screening
* A subject who weighs 50 kg or more at the screening visit and has a body mass index (BMI) of 18.0\~30.0 kg/m2
* A subject who is judged to be eligible to participate by the results of screening tests (vital signs, clinical laboratory tests, 12-lead ECG, etc.) by the principal investigator within 28 days before the first administration of the investigational drug
* A subject and their partner who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 28 days after the last dose of the investigational drug
* A subject who voluntarily signs the consent form after hearing and understanding the purpose and content of this study, thge characteristics of the investigational drugs, expected adverse reactions, and etc.

Exclusion Criteria:

* A subject who has a history or present symptoms of clinically significant liver, kidney, nervous system, respiratory system, digestive system, endocrine system, blood/tumor, urinary system, cardiovascular system, musculoskeletal disease, or psychiatric disease
* A subject who has an acute illness within 28 days prior to the first dose of investigational drug
* A subject who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
* A subject who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month prior to the first administration
* A subject who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the investigational drug
* A subject who is judged unsuitable to participate in this study by the principal investigator
The Study of EIT-guided Ventilation Strategy on ARDS Patients

This study is a clinical randomized controlled study.The objective of this study is to compare the prognosis of patients with ARDS between eit-v / q-oriented individualized ventilation strategy and traditional lung protection ventilation strategy, and to establish the demonstration application of eit-v / q-oriented ventilation strategy in ARDS


Eligibility Criteria:
Inclusion Criteria:

1. According to ARDS Berlin standard, ARDS, PaO2 / FiO2 \< 200mmhg, peep \> 5cmh2o;
2. According to clinical judgment, lung recruitment therapy is needed due to hypoxemia;
3. The subjects or their families signed informed consent.
4. Admission to ICU was less than 72 hours;
5. The estimated duration of mechanical ventilation was more than or equal to 48 hours;
6. Age ≥ 18 years old and ≤ 80 years old;

Exclusion Criteria:

1. The patients with heart implants could not be monitored by EIT;
2. Patients or their families refused to participate in the study;
3. Hypernatremia
Evaluation of Drug Spread in Ultrasound-Guided Erector Spina Plane Block With Fluoroscopy

The purpose of this study is to evaluate the injectate spread in erector spinae plane blocks under fluoroscopy.

The study will be carried out between March 2021 and June 2021 in Istanbul University Istanbul Medical Faculty Pain Medicine Clinic. Patients who undergone erector spinae plane block for any indication over the age of 18 will be included in the study.

All procedures will be performed in the operating room under standard monitorization (ECG, pulse oximetry, non-invasive blood pressure) and all patients will be in the prone position. The application area will be sterilized with povidone-iodine solution. Mild sedation will be achieved by using 1-2 mg of midazolam and 50-75 µg of fentanyl iv. The target area will be visualized by General Electrics (GE) Logiq e Ultrasound device using a 10-12 MHz linear probe or 1-4 MHz curvilinear probe. Transverse processes and erector spina muscles will be visualised at the target vertebral level. After local anesthesia (1-2 cc 2% lidocaine), a 20 gauge spinal needle will be inserted using the "in-plane technique". The needle will be advanced to the transverse process, after it's position is confirmed with hydrodissection, a solution of 40 mg triamcinolone, 10 ml 0,5% bupivacaine, 10 ml radiopaque contrast agent will be injected. Contrast spread will be evaluated with the fluoroscopy in the anterior-posterior and lateral positions immediately and 30 minutes after the procedure. The level of contrast radiating in the AP plane and passing through the paravertebral space and the epidural distance in the lateral plane will be noted. In addition, sensory examination with a pin prick test will be performed to determine the presence of dermatomal hypoalgesia and/or analgesia.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years old
2. Patients who underwent erector spinae plane block for any reasons

Exclusion Criteria:

1. Age under the age of 18
2. Patients without a clear contrast spread under fluoroscopy
Effects of GLP-1RAs on Reproductive Outcomes in PCOS and Obesity

The goal of this clinical trial is to examine whether benalutide combined with metformin and healthy lifestyle education in women with PCOS and obesity prior to fertility treatment improves live birth rate and other reproductive, maternal and perinatal outcomes compared to metformin plus healthy lifestyle education.

Benalutide, a short-acting recombinant human GLP-1RAs with nearly 100% homology to human GLP-1, has been approved by the Chinese National Medical Products Administration for treating weight loss in individuals with obesity. Up to now, there is a paucity of research on the potential impact of GLP-1RAs on reproductive, maternal and perinatal outcomes in women with PCOS and obesity undergoing fertility treatment. Given its effectiveness as a weight loss medication, benalutide theoretically holds promise for enhancing reproductive outcomes in women with PCOS and obesity prior to fertility treatment by facilitating weight reduction.

Eligibility Criteria:
Inclusion Criteria:

Women with a wish to conceive; Women with PCOS (Rotterdam criteria); 28 kg/m2≤BMI\<35kg/m2;

Exclusion Criteria:

Women with medical morbidity; Endocrine disorders; Abnormalities in liver and kidney function; Other medications such as glucocorticoids, anti-androgen drugs ;(spironolactone, cyproterone acetate, flutamide, etc.) within the last 3 months; Acute infections, severe cardiovascular disease, malignant tumors; Ongoing weight loss therapy (\>5% weight loss in the last 3 months) or history of gastrointestinal surgery; Uterine anomalies or untreated tubal hydrosalpinx; Receiving a donor oocyte or donor sperm cycle; Chromosome abnormality or recurrent miscarriage; planning preimplantation genetic testing (PGT); Any other contraindications to fertility treatment; Allergic to or contraindicated for GLP-1 class medications.
Development of the Effectiveness of Rehabilitation Tools for Neurovisual Disorders in Patients With Posterior Cortical Atrophy

Posterior cortical atrophy (PCA) is manifested by neuro-visual disorders that alter the spatial location of objects, their manipulation and/or recognition. Its etiology is most often neurodegenerative, with a major impact on the autonomy and mood of patients and their families. Few studies have focused on non-medication management of these disorders.

The present study thus has a double objective: the development of a complete tool to work on the recognition, localization and/or manipulation of objects; and the evaluation of the effectiveness of this type of management.


Eligibility Criteria:
Inclusion Criteria:

* Age \>50 years old
* Male or Female
* Patients with a diagnosis of PCA according to the criteria of Tang-Wai et al (2004)
* MMS\>15
* Voluntary, written and informed consent of the patient himself or its legal representative (guardian/curator), with oral consent of the patient in all cases
* Anti-Alzheimer's and psychotropic treatments stable for one month, if taken by the patient
* Affiliation to a social security system

Exclusion Criteria:

* Uncorrected visual disorders with non-degenerative etiology (AV\<0.5)
* Person under the protection of justice
* Pregnant women (a pregnancy test will be performed in premenopausal women)
Radiotherapy in Preoperative Setting With CyberKnife for Breast Cancer

The aim of this study is to prospectively evaluate, in patients affected by early breast cancer, safety and feasibility of single fraction radiotherapy with Cyberknife R in preoperative setting, and to identify factors predictive for outcome based on biologic and clinical parameters.

Monocentric, open-label, single-arm phase II study evaluating safety and efficacy of neoadjuvant radiotherapy in early breast cancer patients. Patients eligible are women aged 50 or more years old, affected by histologically proven invasive breast cancer, with positive hormonal receptors, grading 1 or 2, HER-2 negative, without lymphovascular invasion, and tumour size up to 2 cm (measured on mammography, ultrasound or magnetic resonance), negative clinical nodal status, eligible for BCS.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Women ≥ 50 years old
3. Histological diagnosis of invasive breast cancer
4. ER positive (≥ 10% of tumoral cells present ER) and/or PR positive (≥ 10% of tumoral cells present PR)
5. Grading 1 or 2
6. Her2 negative (IHC 0-1+; in patients with IHC 2+, absence of amplification at FISH
7. No lymphovascular invasion evidence at biopsy
8. Early breast cancer (T1 N0 M0) clinically and radiologically defined (ultrasound study/ magnetic resonance)
9. Patients eligible for BCS.

Exclusion Criteria:

Extension of breast disease within 5 mm from the skin surface 2. Tumor size \&gt; 2 cm 3. Patients affected by collagenopathies 4. Patients with BRCA1/2 mutations 5. Previous irradiation to homolateral breast 6. Previous irradiation to homolateral thoracic wall 7. DCIS and/or Paget's disease 8. Psychiatric disorders preventing informed consent signature.

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An Evaluation of Operating Room Staff's Awareness of Environmental Sustainability and Medical Waste Management

The main goals of this single-centre cross-sectional study were to measure views on the environmental effects of the operating room and identify the main barriers to recycling in the operating room environment as perceived by the staff. Participants responded a questionnaire to measure their opinions and the views.


Eligibility Criteria:
Inclusion Criteria:

* all personel working in operating room

Exclusion Criteria:

* missing data
COLchicine On-admission to Reduce Inflammation in Acute Coronary Syndrome (COLOR-ACS)

Since colchicine is known to have anti-inflammatory effects and inflammation is an early component of acute coronary syndrome (ACS), this study aims to evaluate the acute effects of low-dose colchicine, in addition to atorvastatin, administered on-admission to statin-naive patients with non-ST elevation ACS scheduled for early invasive strategy.

On-admission all statin naive NSTEACS patients are randomized to receive either standard treatment of atorvastatin 80 mg or standard treatment plus colchicine (1 mg loading dose followed by 0.5 mg/day).

Inflammatory biomarker high sensitivity C reactive protein (hs-CRP) is measured in all patients on-admission and every 24 hours thereafter until discharge.

Cardiac and renal function parameters are evaluated to evidence the possible beneficial effects of the administration of colchicine in addition to atorvastatin alone both short- and medium-term (up to 30 days).

Colchicine tolerance is also investigated through monitoring for clinical side effects.

Eligibility Criteria:
Inclusion Criteria:

* non-ST elevation acute coronary syndrome;
* ≥ 18 years;
* statin-naive.

Exclusion Criteria:

* prior statin therapy and/or colchicine treatment;
* known allergy or hypersensitivity to colchicine or statins;
* current treatment with potent inhibitors of CYP3A4 or P-glycoprotein (eg., Cyclosporin, antiretroviral drugs, antimycotics, erythromicin and clarythromycin);
* previous or scheduled administration of any immunosuppressive therapy;
* known active malignancy;
* severe kidney disease (creatinine \> 3 mg/dl or dialysis)
* severe liver disease (ALT and/or AST, \> double ref. normal values in case of (a) total bilirubin \> double ref. normal values, or (b) alteration in coagulation (INR\> 1,5);
* severe heart failure (NYHA class ≥ 3 or cardiogenic shock) at hospital presentation;
* severe acute or chronic gastro-intestinal disease (nausea, vomiting, diarrhea, malabsorption disease, malnutrition);
* pregnancy or lactation;
* current COVID-19 or other infectious disease;
* refusal of consent.