cyrilzakka/clinical-trials huggingface dataset:
Prospective Open Clinical and Genetic Study of Patients With Retinitis Pigmentosa

This study is aimed to characterize Russian population of Retinitis Pigmentosa

This study is aimed to characterize Russian population of Retinitis Pigmentosa.

Tasks:

Stage 1. Formation of the primary cohort of patients. Patients pre-recruiting will be performed based on Deaf-Blind Support Foundation "Con-nection" patient database analysis and from references. Patients with clinically confirmed Retinitis pigmentosa will be evaluated according to available data of the clinical examination.

Stage 2. Genetic study of patients. All enrolled patients will undergo single 4 ml peripheral venous blood sampling. DNA will be extracted from leucocytes. DNA samples will be analyzed and placed for long-term storage in liquid nitrogen. Stage 3. Clinical examination of patients.

Each patient will undergo the following diagnostic procedures according to the unified protocol:

* Visometry (with correction and without correction)
* Ophthalmoscopy
* Perimetry
* Optical coherence tomography
* Electroretinography
* Visually evoked potentials
* Refractometry
* Pneumotonometry
* Biomicroscopy
* Any additional examinations and consultations if necessary Medical record will be developed and maintained for each patient consisting results of extended clinical examination.

Statistical and bioinformatic analysis of detected genetic mutations in the study cohort will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patient fulfill the clinical characteristics for Retinitis Pigmentosa (AD, AR, X-linked, sporadic) as defined by the Retinitis pigmentosa consortium
* Results of perimetry for each eye show narrowing for 15 degrees or more.
* Patient is familiar with Participant information sheet
* Patient signed informed consent form

Non-inclusion Criteria:

* Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
* Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.)
* Medical history of traumatic injury of eyes, barotrauma, concussion, craniocerebral trauma, cerebrovascular accident
* Congenital multiple development orbit and eye malformations

Exclusion Criteria:

* Patient's refusal from the further participation in the trial
* Decompensated diabetes mellitus
* Severe coronary artery disease
* Chronic infectious disease
* Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy
CAR-T Treatment for Relapse / Refractory Type Safety and Effectiveness of Lymphoma

The safety and feasibility of CAR-T cells (CD19.CAR-T) targeted at CD19 in the treatment of relapsed / refractory CD19 positive lymphoma were determined, and the proliferation and survival time of CD19.CAR-T cells in patients were determined.

The sponsors of this research also studied CD19.CAR-T cells for the treatment of leukemia and lymphoma, two courses of three transfusion 14 days after infection process standard training program , the safety and effectiveness have accumulated some of the data. In this study, the investigators will regenerate the cultured cells for 2 times in a course of treatment, and enter the patient's body . The investigators observed the safety and efficacy of CAR-T cell therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age is 16 years old, less than 70 years old, sex is not limited, race is not limited;
2. The pathological diagnosis was CD19 positive expression of B type lymphoma relapsed / refractory, meet any one of the following can be diagnosed with relapsed / refractory lymphoma: 1）the standard scheme of standardized treatment of more than 4 courses in 50%, or the condition of tumor size;2） standard treatment of CR, but the recurrence of use the original scheme or the current national consensus recommended second-line treatment can not get CR again;3） the relapse after haematopoietic stem cell transplantation;
3. The patient needs to have a lesion that can be used to detect or evaluate the disease.
4. 0\~1 score of physical status score of the eastern cancer cooperation group (ECOG).
5. At the time of collection of peripheral white blood cell counts over 1 \* 10\^9/L;
6. Expected survival time \> 90 days;
7. Patients have the ability to know and sign informed consent.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Uncontrolled infection;
3. HIV infected people, hepatitis B or HCV active stage;
4. Needs patients with long-term immunosuppressive therapy (such as allergies, autoimmune diseases, GVHD, etc.).
5. Combined with active central nervous system malignant tumor invading;
6. Has abnormal coagulation function, and there are patients with serious thrombus.
7. Organ failure (Appendix); A. heart: Grade II and above; B. liver: higher than grade II; C. kidney: second stages of renal insufficiency and above; D. lung: the second grade was slightly hypofunction and above. E. brain: metastatic or active lesion of the central nervous system.
8. Patients who participated in other clinical trials in the past 30 days or in other clinical trials;
9. Researchers believe that patients are not suitable for the study.
Intraocular Pressure, Optic Nerve Sheath Diameter and Optic Perfusion Pressure of Minimal Low and High-Flow Anesthesia

The aim of this clinical trial is to determine the effect of minimal low-flow versus high-flow anesthesia on intraocular pressure (IOP) by non-contact tonometry, optic nerve sheath diameter (ONSD) by USG and optic perfusion pressure (OPP) in percutaneous nephrolithotomy operations. He will also learn about the effect on hemodynamic responses and arterial oxygenation. The main questions it aims to answer are:

What are the effects of low-flow anesthesia combined with prone position on intraocular pressure (IOP), optic nerve sheath diameter (ONSD) and optic perfusion pressure (OPP)? Which anesthesia flow type has optimal eye-protective results? The investigators will compare minimal low-flow and high-flow anesthesia.

Participants:

The study will include patients between the ages of 18-60 years with ASA (American Society of Anesthesiologists) risk classification I-II-III, who are scheduled for unilateral percutaneous nephrolithotomy (PCNL) operation in the Urology Clinic under elective conditions and who have given informed consent.

Today, rapidly depleting resources and deteriorating ecosystems bring the concept of sustainability to the forefront in all areas. Anesthesia applications have also become an important evaluation subject in terms of sustainability. One of the important components of sustainable anesthesia is low-flow anesthesia. Low-flow anesthesia technique is a technique based on the re-breathing of at least half of the gas exhaled in semi-closed systems by returning at least half of the exhaled gas to the patient in the next inspiration (1). This reduces anesthetic gas consumption, reduces the carbon footprint and prevents environmental pollution. In addition, low-flow anesthesia protects mucociliary clearance mechanisms by preventing airway moisture loss and supports the physiological balance of the respiratory system (2). With the widespread use of low-flow anesthesia, research on the systemic effects of this method compared to high-flow anesthesia has also increased. Prone position may lead to undesirable effects such as increased intracranial pressure, increased intraocular pressure, increased cerebral blood flow and atelectasis. Although the effects of this position on intracranial and intraocular pressure are well known, studies on the effect of low-flow anesthesia on these parameters are limited. Therefore, how the use of low-flow anesthesia in combination with the prone position changes these effects should be evaluated in larger-scale studies (3).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-60 years
* ASA (American Society of Anesthesiologists) risk classification I-II-III
* Unilateral percutaneous nephrolithotomy (PCNL) operation

Exclusion Criteria:

* Patients with drug and alcohol addiction,
* long-term smoking history (at least 1 pack/1 year),
* BMI\>35,
* chronic lung disease,
* cerebrovascular disease,
* severe systemic diseases such as kidney, liver or advanced heart failure .
Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients

The purpose of this study is to determine if Revlimid will help maintain patients with acute myeloid leukemia in remission.

At present, the majority of AML patients \>60 years of age that achieve CR and thereafter successfully complete further chemotherapy, are not candidates for allogeneic bone marrow transplantation (alloBMT) due to their age. Rather, this group of patients is simply observed until relapse occurs. In this age group, the median duration of CR is only \~10 months. The survival of patients \<60 years of age who are not candidates for transplantation (due to donor unavailability), and who are in CR2 or higher is also extremely poor. Several lines of evidence suggest that the immune system - and in particular AML specific CTLs and NK cells - is capable of recognizing and clearing AML cells.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Acute myeloid leukemia in remission.
* Able to take aspirin 81mgs daily.

Exclusion Criteria:

* Pregnant or breast feeding females.
* Known hypersensitivity to thalidomide.
* Any prior use of lenalidomide.
Technology Intensified Diabetes Education Study in African Americans

The purpose of this study is to test the usefulness of an intervention that combines technology with diabetes education and skills training. This study has been designed specifically for African Americans with poorly controlled type 2 diabetes.

African Americans (AA) with type 2 diabetes (T2DM) have higher prevalence of diabetes, poorer metabolic control (i.e. poorer blood glucose, blood pressure, and lipid control), and greater risk for complications and death compared to White Americans. Hemoglobin A1c (HbA1c) is the primary marker for glycemic control and is a strong independent predictor of development of complications and increased mortality in T2DM. Key self-care behaviors that influence glycemic control (and HbA1c) include diet, physical activity, self-monitoring of blood glucose and medication adherence. Systematic review of multiple randomized clinical trials (RCTs) show that self-care interventions that include diabetes education and skills training are effective in improving metabolic control in diabetes. Recent findings indicate that patients with diabetes, especially ethnic minority patients, prefer telephone-delivered diabetes education to group visits or internet-based education. Multiple RCTs have documented the effectiveness of telephone-delivered self-care interventions in T2DM. Preliminary data from our group also suggest that a culturally-tailored telephone-delivered diabetes education and skills training intervention is an effective strategy to improve metabolic control in AA patients with T2DM.

This study provides a unique opportunity to address gaps in the literature by testing the efficacy of a technology-intensified diabetes education/skills training (TIDES) intervention in AAs with poorly controlled T2DM. The long-term goal of the project is to identify effective strategies to improve metabolic control and hence reduce diabetes complications and mortality rates in AAs with T2DM.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥21 years
* Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit
* Self-identified as AA
* Subject must be willing to use the FORA monitoring system for 12 months
* Subjects must be able to communicate in English
* Subjects must have access to a telephone (landline for data uploads) for the study period

Exclusion Criteria:

* Mental confusion on interview suggesting significant dementia
* Participation in other diabetes clinical trials
* Alcohol or drug abuse/dependency
* Active psychosis or acute mental disorder
* Life expectancy \<12 months
Clinical Acceptability of I-GEL® in Pediatric Patients: Comparison of Clinical Performance With Classic-LMA™

This study is designed to determine whether a functional difference exists between the laryngeal mask airway (LMA)-Classic™ and i-gel in anesthetized children who have received neuromuscular blockade.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II, Mallampati I or II, presenting for elective surgery who require general anesthesia in whom tracheal intubation is not necessary

Exclusion Criteria:

* Patients will be excluded from the study if they present as Mallampati III or IV, ASA III-V or emergency status
* upper airway abnormality
Creation of a Probabilistic Atlas of Normal Cerebral Uptake of 18F-FDG in PET/MRI.

With 18F-FDG PET, we have few atlases of normality allowing the realization of objective quantitative analyses. An atlas of normality is a probabilistic atlas of normal FDG uptake from a representative set of brain PET images of healthy subjects. This type of atlas is essential for intra- and inter-individual comparisons.

Accurate quantitative analysis of brain 18F-FDG PET images acquired on a hybrid PET system has been shown to require an institutional normal database for statistical analyzes (Akdemir et al., JNM 2017 and Della Rosa et al Neuroinformatics, 2014).

This is a prospective, monocentric, non-randomized study, with no direct individual benefit since it involved healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 20 to 50
* Absence of any history or cardiovascular, neurological or psychiatric deficit
* Signed the informed consent

Exclusion Criteria:

* Contraindication to the realization of an MRI or PET and to the injection of 18F-FDG
* People using a pacemaker or insulin pump
* People wearing a metal prosthesis or an intracerebral clip
* People with intraocular metal splinters
* People with a pathology considered incompatible for the production of the atlas according to the investigator
* Pregnant women and breastfeeding women
* Subject in period of exclusion.
Endothelial Microparticles: A Novel Marker of Vascular Dysfunction

The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment with calcineurin inhibitors (CNIs) are each associated with the release of endothelial microparticles into the plasma.

The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment with calcineurin inhibitors (CNIs) are each associated with the release of endothelial microparticles into the plasma. These injury-associated microparticles have a different molecular/protein composition than those released from endothelial cells in healthy patients, and their abundance correlates with vascular injury. To test this hypothesis the investigators propose a 3 arm case-controlled study including normal controls, individuals with stage III and IV CKD not receiving CNI therapy, and individuals with stage III and IV CKD post kidney transplantation receiving a CNI. The goal of this study is to measure the amount of microparticles in patients with kidney disease who have had a kidney transplant. Another goal of this study is to see if the measurements of microparticles are related to poor function of the vessels (endothelial dysfunction).

Eligibility Criteria:
Inclusion Criteria:

For Healthy controls:

* BMI less than 40 kg/m\^2
* Able to give informed consent

For Stage III or IV CKD patients:

* BMI less than 40 kg/m\^2
* Able to give informed consent
* An estimated Glomerular-Filtration Rate (GFR) of 20-60 mL/min/1.73m\^2

For Post-kidney transplant and stage III or IV CKD patients:

* BMI less than 40 kg/m\^2
* Able to give informed consent
* An estimated Glomerular-Filtration Rate (GFR) of 20-60 mL/min/1.73m\^2

Exclusion Criteria:

For Healthy controls:

-Women pregnant or breastfeeding

For Stage III or IV CKD patients:

* Women pregnant or breastfeeding
* Adults with a life expectancy of less than one year
* A history of significant liver disease or congestive heart failure
* Hospitalization within the last three months
* Active infection on antibiotic therapy
* Uncontrolled hypertension (\>140/90)
* Immunosuppressive therapy within the last year

For Post-transplant stage III or IV CKD patients:

* Women pregnant or breastfeeding
* Adults with a life expectancy of less than one year
* A history of significant liver disease or congestive heart failure
* Hospitalization within the last three months
* Active infection on antibiotic therapy
* Uncontrolled hypertension (\>140/90)
Autofluorescence vs Clinical Assessment of Parathyroid Glands During Thyroid Surgery

The purpose of the investigation is to study if the use of Fluobeam®-LX to identify parathyroid glands through autofluorescence during thyroid surgery, may reduce the risk of postoperative hypoparathyroidism, defined as low PTH in patients undergoing total thyroidectomy

Temporary and permanent hypoparathyroidism is probably the most important complication of total thyroidectomy. The rate of permanent hypoparathyroidism in quality registries are in the range of is 5-7 percent of patients undergoing surgery.

Patients operated on benign disease with total thyroidectomy, and who suffer from permanent hypoparathyroidism (defined as medication with active Vitamin D analogue therapy for more than 6 months, are at increased risk of renal insufficiency. They also have, for unclear reasons, an increased risk of suffering from malignancy, compared to patients without this complication. Patients with known ischemic heart disease before surgery also have an increased risk of suffering a new episode of cardiovascular disease. Finally, patients with permanent hypoparathyroidism have an increased risk of mortality compared to patients without this complication.

If, by using a technique for autofluorescence (Fluobeam® -LX), one can more accurately identify and avoid damage to the parathyroid glands during the surgical procedure, this would be of great importance for patients undergoing total thyroidectomy for thyroid disease.

Patients undergoing total thyroidectomy are randomized to the use of Fluobeam® -LX to detect the parathyroid glands through autofluorescence during thyroid surgery, or clinical evaluation only (control). Outcome is evaluated by parathyroid hormon (PTH) levels the first postoperative day and the need for medication with calcium and Vitamin D up to 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

Patients with thyroid disease planned for total thyroidectomy regardless of diagnosis

Exclusion Criteria:

* Previous thyroid surgery
* Previous parathyroid surgery
* Concurrent parathyroid surgery
* Renal insufficiency
* Pregnancy
* Breast feeding
* Allergy (contrast agent, iodine)
* Inability to understand study information
* Patient unable to participate in planned follow-up program
Cerebellar Non-invasive Stimulation in Ataxias

Cerebellar ataxias are a group of disorders caused by cerebellar affections, for which currently no specific treatment is available. Some limited studies verified the effects of cerebellar transcranial magnetic stimulation (TMS) on ataxic symptoms, with good results. So far it is not known which patients could benefit. Our hypothesis is that cerebellar TMS could improve ataxic symptoms in some patients.

Thirty patients with cerebellar ataxia will be included in our protocol. Ataxia might be due to several aetiologies, from degenerative to genetic and vascular diseases. Patients will be submitted to a neuronavigation protocol for the precise location of the dentate nucleus contralateral to the most symptomatic side. After that, participants will be randomly assigned to 5 active or 5 placebo sessions of 1Hz TMS over the located area. After the first 5 sessions and a period of at least 4 weeks washout, patients will cross over and receive other 5 sessions, active or sham. Clinical and video evaluations will be conducted before and after active and sham cluster of sessions.

Eligibility Criteria:
Inclusion Criteria:

* identification of cerebellar ataxia based on neurologic examination
* no improvement after rehabilitation
* symptoms onset of at least 6 months

Exclusion Criteria:

* Younger than 18 months
* Pregnant or breastfeeding women
* Participation in other clinical trials
* Epilepsy
Assessment of Tumor Vascular Effects of Axitinib With Dynamic Ultrasonography in Patients With Metastatic Colorectal Cancer

The purpose of this study is to evaluate and quantify the dynamic modifications of tumor blood perfusion on axitinib therapy in patients with refractory mCRC for each dose of Axitinib.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed diagnosis of CRC
* Measurable metastatic disease to the liver in proven disease progression (according to RECIST criteria) at baseline (within 4 weeks prior to study entry), with at least one lesion \> 2cm considered appropriate for DCE-US examination
* Previously exposed to at least, irinotecan, oxaliplatin and a fluoropyrimidine, all 3 administered at optimal doses, over one or two chemotherapy (CT) lines for metastatic disease with a clear resistance to these drugs. Previous exposure to bevacizumab and/or anti-EGFR monoclonal antibody is allowed.
* Age ≥18 years; Performance Status (PS) 0-2 and life expectancy \> 3 months.
* Adequate biological functions: Neutrophils ≥ 1.5 x 109/L; Platelets ≥ 100 x 109/L; Hemoglobin \> 9 g/dl; Creatinine clearance \> 30 ml/min (cockcroft \& Gault formula). Serum bilirubin \< 1,5 x the upper normal limit (UNL) and AST/ALT \< 5 x UNL.
* Signed written informed consent
* Female patients with childbearing potential (\<2 years after last menstruation) and male must use effective means of contraception during the study treatment and at least 6 months after the last study drug administration.
Protective Ventilatory Strategy in Potential Organ Donors

The aim of the study is to verify if a "PROTECTIVE" ventilatory strategy (low tidal volume and high PEEP, application of CPAP during the apnea test and recruitment maneuvers), improves lung function and increases the number of lungs eligible for transplantation.

Lung transplantation reduces mortality in patients with severe pulmonary diseases. While 50-70% of kidney, liver and heart are eligible for transplantation, only 20% of the lungs fit the criteria for transplant. More than 30% of the lungs theoretically suitable for donation are not actually collected because following brain death they develop severe hypoxemia and abnormal chest X-ray. Guidelines for critical care management of potential organ donors suggest that after the diagnosis of brain death, treatment priority can be shifted from cerebral protection to a strategy aimed at preserving solid organ perfusion and function. However the ventilatory strategy recommended for potential lung donors is similar to the one proposed for brain injured patients. This ventilatory strategy based on high Vt and low PEEP may induce a further exacerbation of the pulmonary and systemic inflammatory response in patients with acute lung injury/acute respiratory distress syndrome. Moreover, recent data suggest that this strategy may be harmful in "normal lungs" of mechanical ventilated patients. Aim of the study is to verify if a "PROTECTIVE" ventilatory strategy (low tidal volume and high PEEP, application of CPAP during the apnea test and recruitment maneuvers) improves lung function. Primary end point of the study is to increase the number of lungs that meet the eligibility criteria for transplantation. Secondary end point is to increase the number of lungs really transplanted.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years
* Chest X-ray: no infiltrates
* Duration of mechanical ventilation from the admission to ICU to the clinical diagnosis of brain death \< 5 days
* No history of Smoking (1 pack/day for 20 years; 1/2 pack/day for 40 years; 2 packs/day for 10 years)
* No history of Asthma
* No history of COPD
* No history of Trauma
* No history of Thoracic surgery

Exclusion Criteria:

* Evidence of aspiration (chest X-ray or bronchoscopy) or sepsis
* Purulent secretions (tracheal suction or bronchoscopy)
* Sputum Gram stain with bacteria, fungus, significant number of WBC