cyrilzakka/clinical-trials huggingface dataset:
24 Week Study to Compare Systemic VEGF-levels of Ranibizumab and Aflibercept in DME.

The purpose of the study is to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF levels in DME patients in a detailed time course.

The purpose of the study is to compare the effect of monthly intravitreal injections of 0.5 mg ranibizumab and 2.0 mg aflibercept on systemic VEGF levels in patients with visual impairment due to DME over a 24 week period. In addition, the study will also assess the effect on systemic VEGF-A levels when patients are switched from aflibercept to ranibizumab.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetes mellitus
* Visual impairment due to DME
* BCVA of 78 to 24 (20/32-20/320) ETDRS letters

Exclusion Criteria:

* Stroke or myocardial infarction less than 3 months prior to screening.
* Presence of uncontrolled systolic blood pressure or diastolic blood pressure
* Renal failure requiring dialysis or renal transplant or renal insufficiency
* Untreated diabetes mellitus
* Use of any systemic anti-VEGF drugs within 6 months prior to screening.
* Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening.
* Women who are pregnant or breast feeding or who are menstruating and capable of becoming pregnant\* and not practicing a medically approved method of contraception

For either eye:

* Any active periocular or ocular infection or inflammation
* Uncontrolled glaucoma
* Neovascularization of the iris or neovascular glaucoma
* History of treatment with any anti-angiogenic drugs

For study eye:

* Atrophy or fibrosis involving the center of the fovea at the time of screening or baseline.
* Cataract (if causing significant visual impairment), planned cataract surgery during the study period, vitrectomy, aphakia, glaucoma surgery, severe vitreous hemorrhage, rhegm
* Irreversible structural damage within 0.5 disc diameter of the center of the macula
* Panretinal laser photocoagulation within 6 months prior to randomization.
* Focal/grid laser photocoagulation within 3 months prior to randomization.
* Any intraocular procedure (including cataract surgery, Yttrium-Aluminum-Garnet capsulotomy) within 3 months prior to baseline or anticipated within the next 6 months following
* Topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening.
* Application of intravitreal corticosteroids in vitreous within 6 months prior to screening. Prior application of fluocinolonacetonid releasing implant in vitreous within 36 months prior to screening.

For fellow eye

- Retinal or choroidal neovascularization or macula edema of any cause Other protocol-defined inclusion/exclusion criteria may apply.
Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

This phase 2 waitlist-controlled, randomized trial is designed to compare the difference in proliferative index (Ki67) between carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on Active Surveillance. Eligible patients include men over 18 years old, BMI \>25, with their most recently performed biopsy pathologically confirming prostate adenocarcinoma who have been placed on AS. Arms of the trial will be randomized 1:1 in a crossover approach, with Arm A receiving a carb restricted diet over 6 months then SOC and Arm B receiving the waitlist control arm (i.e. SOC then allowed to go on diet after 6 months). Ki67 will be performed on tissue from the most recent biopsy at the beginning of the study and again on tissue obtained in the 6 month SOC biopsy. Every patient will be on the study for 12 months, and the study will continue for approximately 3.5 years.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed prostate adenocarcinoma
* Most recent biopsy positive for prostate cancer
* Currently on or starting active surveillance
* Ability to read, write, and understand English
* BMI \>24 kg/m2
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
* Scheduled to undergo a prostate biopsy in 6 months as part of standard of care for their prostate cancer
* Age \> 18 years

Exclusion Criteria:

* Already consuming a severely carbohydrate-restricted (i.e. \<20g total carbohydrates per day) or vegetarian diet
* Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
* Anticipate needing prostate cancer therapy within the next 12 months (i.e. surgery, radiation, or hormonal therapy)
* Loss of \>10% of body weight within the previous 6 months
* Currently receiving any oral hormonal therapy for prostate cancer or BPH (finasteride, dutasteride, bicalutamide)
* If prior oral hormonal therapy use for prostate cancer or BPH (as defined above), must not have been taking at time of prior biopsy and must be off for at least 3 months prior to study enrollment (oral medications)
* Having ever received any injection hormonal therapy or investigational vaccine for prostate cancer (LHRH agonist, LHRH antagonists, ProstVax, Provenge)
* Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program
Non-Invasive Aortic Ambulatory Blood Pressure Monitoring for The Detection of Target Organ Damage in The Chinese Population

This study is a sub-investigation of SAFAR study. Consecutive patients with established hypertension (treated or untreated with antihypertensive drugs) or with suspected hypertension are recruited and their 24-hour brachial and aortic blood pressures, cardiovascular risk factors and target organ damage are assessed. And the participants' target organ damage, cardiovascular events, cardiovascular and overall mortality will be followed four years later.

SAFAR study is an ongoing perspective study which is performed in Greek. We have been participated this study and now we are going to expand this study in Chinese population.

In Shanghai Tenth People's Hospital, we recruit consecutive patients who meet the including criteria. And their medical and family history are obtained with standardized structured questionnaire including information about smoking and drinking and exercise habits, history of diabetes mellitus, cardio-cerebrovascular disease, renal disease and peripheral arterial disease, use of antihypertensive, lipid-regulating and hypoglycemic drugs. Their biochemical examinations of venous blood and urine were measured after an overnight fast.

For the 24-hour brachial and aortic ambulatory blood pressure monitoring of each patient, we use the Mobil-O-Graph NG apparatus (IEM, Stolberg, Germany), which is well validated and now commercially available.

All participants underwent carotid and cardiac ultrasonography by a validated ultrasound system (Mylab 30 CV machine, ESAOTE SPA, Genoa, Italy). The parameters of cardiac function and structure and the parameters of carotid arteries are assessed according to the ASE recommendation. Further, we use these parameters to estimate the damage of heart and carotid artery including left ventricular mass index (LVMI), carotid left ventricular diastolic function (LVDD), intima-media thickness (CIMT) and cross-sectional area(CCSA).

Four years later, the above measurements will be performed again and the corresponding data of events and mortality will be collected.

Eligibility Criteria:
Inclusion Criteria:

* patients with established hypertension (treated or untreated with antihypertensive drugs) or with suspected hypertension

Exclusion Criteria:

* Age\<18 years old
* the absence of sinus rhythm during BP monitoring
* any modification in cardiovascular disease medication in the past month
* inability to provide informed consent or unwillingness/inability to adhere to study protocol
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives

To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions.


Eligibility Criteria:
Inclusion Criteria:

* Persons 18 to 85 years of age at the date of informed consent.
* If presenting with a history of a specific condition, the diagnosis is confirmable in the medical record or may be confirmed using other forms of verification including self-reporting.
* Understands the procedures and requirements of the study by providing written informed consent (or verbal assent if a legally authorized representative will sign the ICF), including consent for authorization for protected health information disclosure.

Exclusion Criteria:

* Persons younger than 18 years of age or older than 85 years of age at the date of informed consent.
* Receipt of blood products 30 days before the study blood draw.
* Receipt of an investigational (unapproved) drug 30 days before the study blood draw.
* A confirmable diagnosis of any medical condition that would increase potential phlebotomy risks.
* Has donated a unit of blood within the last 2 months at the date of informed consent.
Electrosurgical Intervention Analysis: Comparing Procedure Patterns

The purpose of this prospective, single center study is to verify the hypothesis that each type of intervention creates a specific data pattern like a digital "fingerprint". This fingerprint offers the possibility to identify specific workflows of surgical procedures but also to differentiate between them, what can be used for training purposes. The following clinical study is not covered by the MDR regulation since we do not investigate performance or safety of a device but collect and assign electrical data only.

The Erbe ESU VIO 3 provides electrical measurement data with high accuracy and time resolution. With the availability of the Erbe ECB Data Transmitter it is possible to record electrical data from the VIO 3 during clinical procedures, which open up a variety of possibilities for enhancing clinical workflows.

For this purpose, the VIO 3 will be connected via ECB (Erbe communication bus) interface with the "Data Transmitter". Using the software implemented by Erbe on the "Data transmitter", electrical data - generated during electrosurgical interventions - are recorded, forwarded via LAN, WLAN or LTE and stored in the Azure Cloud. These data do not contain any patient information and will be only used for the stated study objective.

In future, based on the analyses of electrosurgical device data users could benefit from e.g. continuous training as well as self enhancement/reflection by electrosurgical information offered during or after a surgical procedure. A first step to reach this goal is to build up a database containing electrosurgical data of different surgical interventions, to identify the electrosurgical "fingerprint" of each intervention and to detect different patterns between them. Therefore, the purpose of this study is to record electrosurgical data and to verify the hypothesis that each type of intervention creates a specific data pattern like a digital "fingerprint".

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Written informed consent
* Patients undergoing one of the following surgeries:

  * Supra cervical hysterectomy
  * Total hysterectomy
  * Breast conserving surgeries: B-plastic + periareolar mastopexy
  * Breast conserving surgeries: segmental resection

Exclusion Criteria:

* Expected lack of patient compliance or inability of the patient to understand the purpose of the clinical trial
* Lack of patient consent
* Surgery under local anaesthesia
* Robot-Assisted Surgery
Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes

The needs of children and teens with type 1 diabetes are very specific and different from the adults with type 1 diabetes. Many organizations such as the World Health Organization or the International Society for Pediatric and Adolescent Diabetes, recommend a patient therapeutic education when it comes to children with type 1 diabetes.

This study aims to evaluate the impact of a therapeutic education program on theoretical knowledge of the disease and also on quality of life, on biological and clinical indicators.

Structuring a therapeutic education program for patients with a chronic disease was the initiative of the French High Health Authority in June 2007.

The Prevention and Care of Pediatric Obesity and Pediatric Diabetes Organization of Mulhouse is a partner of the Mulhouse Hospital. Besides the usual care given at the hospital of Mulhouse for patients with a type 1 diabetes, both organizations also provide therapeutic education to these patients.

Each therapeutic education program is organized according to the patient's age. They can also be organized in a group or individually.

The aim of the therapeutic education is to help the young patients to cope with diabetes in their daily activities. Therapeutic education is known to bring good results for patients with diabetes, but there is no studies in France for children and teens with a type 1 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment between January 15 to March 15, 2016
* Insulin-dependent type 1 Diabetes
* Treatment received at the Hospital of Mulhouse, France

Exclusion Criteria:

* Opposition to study participation
* Behavioral issues
* Uncontrolled psychological issue
Clinical Proteomic Research for the Brain

The study of plasma and urine proteomic profiles in patients with ischemic brain injury is important to better understanding of the mechanisms by which thrombolytic agents or other therapy affects clinical outcomes. The purpose of this study is to study the proteomic profile of patients with ischemic brain injury and compare it to control subjects without ischemic brain injury, subjects with other chronic neurologic diseases or systemic vascular diseases, and pre- and post- therapy which may be associated with, or predictive of, therapeutic outcome.

The investigators hypothesize that there is a unique set of proteins expressed in serum and urine in patients with ischemic brain injury that may provide a more complete understanding of ischemic brain injury pathophysiology.

Ultimately, this study may provide information of direct relevance to the medical care of a large proportion of patients with ischemic brain injury and other neurologic diseases in the future. And proteomic proteomic profile may provide important information about the roles of specific biomarkers. Perhaps the prevention of ischemic injury related complications.


Eligibility Criteria:
Case Inclusion and Exclusion Criteria:

Inclusion Criteria:

1. Ischemic brain injury within 12 hours of symptom onset;
2. Including primary ischemic brain injury from embolism or arterial occlusion or secondary due to increased ICP after trauma, subarachnoid hemorrhage.

Exclusion Criteria:

1. Patients who are hemodynamically unstable for venipunctures;
2. Anemic patients (hemoglobin \< 11);
3. Children;
4. Pregnant women.

Controls Inclusion and Exclusion Criteria:

Inclusion Criteria:

1. Healthy adults without any neurologic or systemic disease;
2. Inpatient or outpatient adults with a chronic stroke (greater than 3 months) or chronic neurologic disease such as neurodegenerative disease, movement disorder, demyelinating disease;
3. Inpatient or outpatient adults with systemic vascular disease.

Exclusion Criteria:

1. Patients who are hemodynamically unstable for venipunctures;
2. Anemic patients (hemoglobin \< 11);
3. Children;
4. Pregnant women.
The Training and Evaluate Effect on Clinical Airway Management

In this self-control experiment, anesthesiologists with limited experiments of bronchoscopy working in anesthesiology department in Peking Union Medical College Hospital will receive a training and evaluation procedure in simulation and clinical practice about clinical airway management. The objects was (1) to investigate the improvements of manufacturing bronchoscopy in simulation and clinical practise before and after training on simulation,(2) to record the efforts trainees needed to achieve experienced on simulation, (3) to evaluate if status manufacturing on simulations could reflect the ones in clinical practise.

A modified global rating scale from 1 (unskilled) to 5 (expert) with a score of 3 linked to proficiency, and 5-points Likert from 1 (felt extremely unsure) to 5 (felt extremely confidence) with a score of 4 linked to confidence were used to evaluate during the procedure of training and evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. An anesthesiologist who is working on anesthesia airway management；
2. During the research period, he/she worked in the anesthesiology department of Peking Union Medical College Hospital；
3. Have some experience in airway management，Meet at least one of the following conditions: ①Airway management experience ≤10 cases；②Objective GRS score \<3 points；③Subjective Likert score \<3 points

Exclusion Criteria:

1. Cannot complete pre-training assessment；
2. Cannot complete the training course；
3. Cannot complete the post-training evaluation；
4. Clinical airway managers were not performed during the study period.
Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of indium In 111 pentetreotide in treating patients who have refractory cancer.

OBJECTIVES: I. Determine the maximum tolerated dose (MTD), toxic effects, and the preliminary antitumor activity of indium In 111 pentetreotide.

OUTLINE: This is a dose escalation study. Patients receive indium In III pentetreotide (OctreoScan) IV on day 1. Imaging is conducted on days 3 and 6. Treatment continues weekly for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of at least 3 patients receive escalating doses of OctreoScan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities. Patients are followed every 3 months for the first year, then every 6 months thereafter.

PROJECTED ACCRUAL: Up to 35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven malignancy with no alternate treatments available Measurable or evaluable progressive disease Somatostatin receptors present on tumor and uptake demonstrated on diagnostic scan with OctreoScan

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1,500/mm3 Hepatic: Total bilirubin no greater than 2.0 mg/dL Renal: Creatinine clearance at least 40 mL/min Other: No active infections Not HIV positive No coexisting medical condition Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior wide field radiation therapy Surgery: Recovery from prior surgery
Comparison of Efficacy of Paravertebral and Epidural Analgesia After Videothoracoscopic Lung Lobectomy

Thoracic surgery correlates with significant pain in postoperative period. In order to alleviate the pain various combinations of pharmaceuticals and administration methods are employed. So as to reduce the extent of surgical trauma and, consequently, correlated pain various operation techniques are used. In traditional thoracotomy epidural anesthesia remains a golden standard. Epidural anesthesia however demands high skills to be performed correctly and presents an increased risk of grave complications. In videothoracoscopic (VATS) operations paravertebral blockade can be employed, yet there is no certainty if its efficacy after lung lobectomy. We therefore designed a prospective, randomized, parallel group, single site study to test the hypothesis, that continuous paravertebral blockade is as efficient in postoperative pain reduction as continuous epidural blockade and possesses a higher safety profile.


Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status 1-3
2. undergo videothoracoscopic lung lobectomy
3. forced expiratory volume in 1 second (FEV1) \>1,5 l/min
4. no contraindications for epidural anesthesia and paravertebral nerve blockade
5. ability to comprehend principles of VAS pain examination method and to communicate in accordance with them.

Exclusion Criteria:

1. prior to the study: contraindications for local anesthesia, ASA\>3, FEV1\<1,5 l/min, conditions disabling the patient from comprehending the principles of VAS pain examination, known allergy to used medications.
2. during the study: failure to place epidural or paravertebral catheter, decision to abandon lobar resection (e.g. in case of neoplastic dissemination), intraoperative conversion to thoracotomy, intraoperative anatomical obstacles to distribution of local anesthetics, conditions disabling the patient from pain evaluation by means of VAS method (e.g. postoperative delirium), necessity to administer other pharmaceuticals influencing pain perception (e.g. sedatives), necessity of mechanical ventilation, interruption of local anesthesia as a result of technical problems (e.g. damage or slippage of catheter).
Yoga as a Supportive Therapy for Patients With Hypertension

The proposed study aims to investigate the feasibility, effectiveness, and perceived benefit of a supportive hatha yoga intervention for patients with hypertension using antihypertensive drugs. Patients will be randomized into 3 groups comparing hatha yoga with yoga postures, breathing and relaxation techniques to a hatha yoga intervention without yoga postures (only breathing and relaxation techniques) as well as to a wait list control group.


Eligibility Criteria:
Inclusion Criteria:

* essential Hypertension
* stable antihypertensive medication during the next 6 months

Exclusion Criteria:

* pregnancy or breast feeding
* simultaneous participation in further clinical intervention trials
* regular yoga practice in the past 12 months
* serious mental illness (severe depression, severe addiction, psychosis)
* manifest coronary heart disease that has been treated in the past 3 months or myocardial infarction, embolism of pulmonary arteries or stroke in the past 3 months
* heart failure ≥ state 1 New York Heart Association (NYHA)
* peripheral arterial occlusive disease ≥ state 1
* renal insufficiency \> state 2, glomerular filtration rate \< 60 ml/min/1,73m² according to he National Kidney Foundation (NKF)