cyrilzakka/clinical-trials huggingface dataset:
Nordic-Baltic Coronary Revascularization Study in Patients With Proximal Left Descending Coronary Artery (LAD) Lesion.

The Nordic-Baltic Heart Team Initiative for improved long-term coronary artery revascularization outcome compares quality of life and survival after coronary bypass grafting (CABG) vs. percutaneous coronary intervention (PCI) in patients with 1-vessel disease and proximal stenosis of the anterior descending artery (LAD/in patients with isolated proximal left descending coronary artery (LAD) lesion

It is not clear how operable 1-VD patients with stable or stabilized coronary artery disease involving a pLAD lesion should be treated to optimize long-term survival and quality of life.

According to recent European guidelines, significant pLAD disease may be treated by PCI or by CABG. This recommendation is based on two meta-analyses including 1.210 and 1.952 randomized and non-randomized patients. Generally, the patients were followed for 4-5 years. The analyses reported similar rates of mortality, MI and stroke, but more repeat revascularizations after PCI. Only one study including129 patients provided more than 5-year follow-up. Thus, the there is limited documentation for long-term effect of PCI vs. surgical re-vascularization in pLAD disease.

The American 2014 Guidelines on coronary revascularization recommends CABG for improved survival in patients with solitary proximal LAD stenosis. CABG

The angiographic 90% LIMA patency rate after 1, 2 and 3 decades is well described and suggestive of a survival benefit of surgical revascularization.

Therefore, there is scientific background for an CABG LIMA-to-LAD vs. PCI comparison in 1-VD patients with a pLAD lesion.

Substantiated expectations:

* PCI is superior to bypass operation concerning short-term quality of life.
* Off-pump LIMA-to-LAD is superior to PCI concerning long-term all-cause mortality.
* Long-term (≥10-year) follow-up is essential to evaluate coronary revascularization strategies.
* Outcome may be dependent on lesion complexity, diabetes and gender.

Eligibility Criteria:
Inclusion Criteria:

Heart Team decision on treatment

1-VD patients with stable coronary artery disease or stabilized unstable angina pectoris/NSTEMI or silent ischemia Proximal LAD (pLAD) stenosis (\>90% by visual assessment or FFR \<80% The lesion may be treated by both PCI and surgery

Exclusion Criteria:

ST-elevation myocardial infarction within 24 hours. Expected survival \<1 year, because of high age or severe cardiac or non-cardiac disease.

Significant LM disease. Earlier CABG. PCI within 3 months. Significant valvular heart disease. Renal failure on dialysis Earlier disabling stroke Relative or absolute contraindication to dual antiplatelet therapy. Allergy relevant to the study treatments. Age \< 18 years. Study required information and consent suboptimal or impossible.
The Optimal Intraoperative Supplemental Oxygen Administration During Minimally Invasive Esophagectomy

The study hypothesized that a relative low oxygen concentration (40%) supplemental would be advantageous to protect the pulmonary function of patients, comparied with conventional high oxygen concentration (80%). Therefore we raise this prospective randomized controlled research.

Patients underwent minimally invasive esophagectomy in Zhongshan Hospital of Fudan University will be enrolled and be randomizedly assigned to low oxygen concentration (40%) supplemental or high oxygen concentration(80%) supplemental group. Intra-operative and post-operative pressure of Oxygen in Arterial Blood will be examined, and the surgical outcome will be recorded in the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy.
2. Patients underwent minimally invasive esophagectomy(Thoracolaparoscopic McKeown procedure).

Exclusion Criteria:

1. Patients with previous thoracic surgery history.
2. Patients with severe Co-morbidity.
3. Pulmonary function is abnormal in the examination before surgery.
Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome

To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with the Antiphospholipid Syndrome Anticoagulated with Vitamin-K Antagonists.

Patients with an antiphospholipid syndrome receiving Vitamin-K antagonists for secondary prevention after a first thrombotic complication are known to be at higher risk of recurrent thrombotic events despite INR values in the therapeutic range. It ist also known that antiphospholipid antibodies can interfere with phospholipid-dependent tests (e.g. prothrombin time and INR).

The primary objective of this study is to determine the prevalence of interfering antiphospholipid antibodies. The intensity of anticoagulant therapy was assessed by measuring the INR using different thromboplastins and the CoaguChek system for INR self-assessment. Test results were compared to measurements of the phospholipid-independent chromogenic factor X.

The second objective of this study is to evaluate the incidence of recurrent thrombotic events during 1-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* age 18-90 years

Exclusion Criteria:

* none
Role of Core Exercise in Treatment of Fibromyalgia Patients

the purpose of this study is to investigate the effect of core exercises on health status, pain, pressure pain thresholds and functional capacity in patients with FM

Fibromyalgia (FM) is a chronic non-degenerative disease of unknown etiology without effective medical treatment that mostly affects women. At present, the diagnostic and classification criteria are still under debate. As a result, the treatments for FM are also under investigation. No single treatment has achieved a reduction in the symptoms. Its occurrence increases with age. Exercise is one of the treatment approaches where effectiveness in the management of FM is supported by stronger evidence. Besides, recent reviews found that exercise has a positive effect on pain, physical function and health-related quality of life .with no associated adverse effects. Among the different exercise modalities available, core stability training has shown its effectiveness by improving static and dynamic balance, functionality and risk of falls, pain and quality of life. so This study will be conducted to investigate the effect of core exercises on health status, pain, pressure pain thresholds and functional capacity in patients with FM

Eligibility Criteria:
Inclusion Criteria:

* 1. Patient referred from rheumatologist with a history of widespread bilateral musculoskeletal pain both above and below the waist for a minimum of three months and pain in at least 11 of 18 specific tender points 2. moderate or greater tenderness reported on digital palpation with 4 kg/cm2 of force 3. 21_43 years old patients

Exclusion Criteria:

- 1. presence of other systemic, somatic, or psychiatric diseases. 2. pregnant or were planning a pregnancy during the study period. 3. patients with acute disease including high fever and uncontrolled medical conditions (such as severe infection and cardiovascular disease including unstable angina.

4. surgical history for previous 6 months.
A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine

This is an open label, dose escalation study with 3 arms (Arms A, B, and C). Arm A will assess the safety and tolerability of escalating doses of SB939 in cohorts of patients with advanced solid tumors. Arm B will assess the safety and tolerability of escalating doses in cohorts of patients with advanced hematologic malignancies. Arm C will assess the safety and tolerability of SB939 in combination with standard azacitidine therapy.


Eligibility Criteria:
Inclusion criteria:

Arms A \& B:

* Patients with solid tumors in Arm A and hematologic malignancies in Arm B that is classified as intermediate 1 or greater according to the International Prognostic Scoring System (IPSS) risk category for whom therapy is indicated;
* ECOG performance status (PS) 0-2;
* Patients must have adequate non-hematologic organ system function.

Arm C:

* Patients with MDS that is classified as intermediate 1 or greater according to the International Prognostic Scoring System (IPSS) risk category for whom therapy is indicated;
* Have not been treated with azacitidine and are a candidate for treatment with azacitidine;
* ECOG performance status (PS) 0-2;
* Patients must have adequate non-hematologic organ system function.
interACTION: A Portable Joint Function Monitoring and Training System to Supplement Home Exercise Programs Following Anterior Cruciate Ligament Reconstruction

The purpose of this study is to ascertain if home-based therapy with monitoring via telemedicine can overcome many barriers to compliance and improve rehabilitation following ACL reconstruction. Patients undergoing ACL Reconstruction will be followed for 6 weeks during their outpatient physical therapy treatment. Subjects will undergo weekly physical therapy or weekly physical therapy paired with InterACTION.


Eligibility Criteria:
Inclusion Criteria:

1. Between 15 to 30 years of age;
2. Have undergone ACL Reconstruction;
3. Being referred for post-operative outpatient physical therapy;
4. Agree to and able to perform pre-designed exercises that they would normally perform in a physical therapy program after ACL Reconstruction.

Exclusion Criteria:

1. Patients undergoing concomitant meniscal repair or other surgical procedure requiring modification of post-operative physical therapy program;
2. Patients with BMI \>40 at the time of surgery;
3. Individuals who are not free of any other co-disability or comorbidity that would specifically impede disallow or otherwise hinder performance of physical therapy exercises;
The Effects of Strength and Balance Training on Physical Function in Overweight Children

This intervention study aims to examine the efficacy of a school-based exercise programme to improve strength and balance in overweight and obese 7-11-year-olds in the United Kingdom. The main question\[s\] it aims to answer are:

* Is the school-based exercise programme effective in improving lower limb muscular strength and balance control?
* How do increases in strength and balance skills impact physical function, the risk to musculoskeletal health, and physical activity? Participants will attend baseline, post-intervention, and follow-up testing that includes assessment of strength, balance, 3D gait, plantar pressure, physical function and physical activity. The intervention group will take part in physical activity sessions in their school for 1 hour twice a week for a total of 8 weeks.

Researchers will compare the intervention group to a control group that will take part in no-activity sessions and carry out their normal school and seasonal activities.


Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese

Exclusion Criteria:

-
The Role of B7-H4 in Tumor Vaccine

Glioma patients have poor prognosis because of limited choices of treatment. Therapeutic cancer vaccines have been proved to improve survival in glioma, but resistance is a new challenge for vaccine treatment, and the mechanism is unclear. The applicant found in previous papers that glioma cells induced B7-H4 overexpression in macrophages, and the expression level of B7-H4 is highly correlated with vaccine resistance. Preliminary experiments indicated that B7-H4 protein in macrophages inhibited the expression of ATF3, STAT1 and CXCL9/10, which also resulted in decreased T cell infiltration in glioma model of mouse and was a negative factor of vaccine benefits. Therefore, the applicant hypothesize that B7-H4 inhibits STAT1 transcription by reducing expression of ATF3, resulting in decreased phosphorylated-STAT1 in nucleus, which inhibiting expression and secretion of chemokines 9/10. Thereby, reduced infiltration of T cells in microenvironment will be followed, which ultimately promotes resistance of vaccine treatment in glioma. The follow-up plan of this project will be conducted based on the cells, organoid platform and animal experiments to confirm the role and mechanism of macrophage-derived B7-H4 in secretion of chemokines for T cells and treatment resistance of vaccines. Moreover, the DC vaccine produced by team of the applicant will be used to assess the probability of reversing vaccine resistance when intervening B7-H4 axis. Finally, a model for evaluating clinical benefits from vaccine will be established based on data from clinical trials combining with expression of B7-H4 and clinicopathologic features. This study will provide new evidences for the treatment of cancer vaccines in gliomas.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

The patients with glioma in the Department of Neurosurgery of Huashan Hospital Affiliated to Fudan University who meet the following three conditions can be enrolled

1. They were 18-80 years old, male and female;
2. The pathological results of frozen section during operation were gliomas;
3. Tissue (6 mm \* 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis;
4. Sign informed consent.

Exclusion Criteria:

Patients who meet any of the following criteria will not be included in this study:

1. Participants in other clinical trials;
2. Pregnant women.
Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw

The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long. The primary hypothesis is that the alteration in bone level is equal in patients randomized to 6 mm as to patients randomized to 11 mm implants.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Aged 20-70 years at enrolment
* History of edentulism in the study area of at least four months
* Neighboring tooth/teeth to the planned bridge must have natural root(s)
* Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
* Deemed by the investigator to have a bone height of at least 11 mm and a bone width of minimum 6 mm
* Deemed by the investigator as likely to present an initially stable implant situation

Exclusion Criteria:

* Unlikely to be able to comply with study procedures, as judged by the investigator
* Earlier graft procedures in the study area
* Uncontrolled pathologic processes in the oral cavity
* Known or suspected current malignancy
* History of radiation therapy in the head and neck region
* History of chemotherapy within 5 years prior to surgery
* Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
* Uncontrolled diabetes mellitus
* Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
* Smoking more than 10 cigarettes/day
* Present alcohol and/or drug abuse
* Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
* Previous enrolment in the present study.
* Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
* Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
A Nurse-led Program for Stroke Patients

The aim of this study is to examine the effectiveness of nurse- led program on psychosocial problems and quality of life in stroke patients. This randomized controlled trial will be conducted in Stroke Center in Istinye University Liv Hospital-Bahcesehir. Eligible participants will be randomly allocated to either the control group (receiving usual care/ routine follow-up group) or the intervention group (receiving nurse-led psychosocial program). A nurse- led program will be implemented for the management of psychosocial problems following a comprehensive evaluation. Then, the effect of this program on psychosocial problems and quality of life will be evaluated in the 1st and 3rd months after discharge.

The aim of this study is to examine the effectiveness of nurse- led program on psychosocial problems and quality of life in stroke patients. This randomized controlled trial will be conducted in Stroke Center in Istinye University Liv Hospital- Bahcesehir. Patients who meet the criteria will be randomized into the intervention group or control group. All patients will be assessed at discharge by use of following tools: National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale, Functional Independence Measure (FIM), Montreal Cognitive Assessment (MoCA), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI). A nurse coordinated multidisciplinary program aiming to improve psychosocial problems has been developed and will be applied to the patients in the experimental group. This nurse-led program will start at discharge and continue for three months. The control group will be applied usual care. Two groups will be compared at baseline and at the 3rd month after discharge in terms of psychosocial variables and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Be literate
* Have a clinical diagnosis of ischemic stroke
* History of any preceding cerebral vascular event
* Capable of giving informed consent

Exclusion Criteria:

* Age ≤ 18 years
* Have a mental disorder that will prevent cognitive evaluation
* Have an impaired consciousness (confusion, delirium, etc.)
* History of any type of cognitive decline
* Have severe neurologicial deficit
* Severe aphasia
* Living in a nursing home
* Known malignant disease or other chronic disease with poor prognosis and a low life expectancy
Home-based Exercise Training for COPD Patients (HOMEX-2)

The aim of this study is to assess the effectiveness of a home-based exercise training program in COPD patients who did not participate in an inpatient or outpatient rehabilitation program within the last 2 years.

Exercise training is an important component of pulmonary rehabilitation (PR) the management of chronic obstructive pulmonary disease (COPD) and numerous trials have shown large improvements in health-related quality of life (HRQoL) and exercise capacity in persons with COPD. However, the great majority of patients who would benefit from PR never follow such a program. Moreover, many COPD patients are either not instructed to exercise at all or fail to adhere to exercise training at home after completing PR.

This study evaluates a newly developed exercise training program that requires minimal equipment (i.e., only a chair and elastic bands) and can be easily implemented long-term in the patient's home-setting.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent after being informed
* Diagnosis of COPD, defined as forced expiratory volume in 1s/forced vital capacity (FEV1/FVC)\<70% predicted, FEV1\<80 % predicted after bronchodilation, with or without chronic symptoms (cough, sputum production) corresponding to a GOLD stage II-IV
* No participation in an inpatient or outpatient pulmonary rehabilitation within the last 12 months
* Male and female patients ≥40 years of age
* Knowledge of German language to understand study material and assessments

Exclusion Criteria:

* Patients not able to conduct the exercise training program due to physical, cognitive or safety reasons, as judged by investigator; e.g., lower limb joint surgery within preceding 3 months, unstable cardiac disease, predominant neurological limitations.
* Planned participation in a pulmonary rehabilitation program
Proteinuria in Pre and Post Transplant

Patients with focal segmental glomerulosclerosis (FSGS) who progress rapidly to end stage renal disease (ESRD) are at highest risk for development of recurrence of proteinuria following kidney transplantation. This study will look at serum specimens pre and post transplant, as well as kidney transplant specimens pre and post reperfusion to identify where the defects has occured that results in recurrence of proteinuria in a given kidney transplant.

This study will retrospectively review patient's medical records for protein in the urine, blood creatinine and kidney biopsy results. Also character of the fluid used to flush the kidney before transplant will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients
* Pediatric males and females up to the age of 25 years old.

Exclusion Criteria:

* Transplant recipients other than kidney
A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis

This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.

This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.

Eligibility Criteria:
Inclusion Criteria:

* Presence of \>6 swollen joints and \>6 tender joints
* Inadequate response to at least one disease modifying anti-rheumatic drug (DMARD)
* Have not been treated with a DMARD for at least 4 weeks prior to the baseline visit

Exclusion Criteria:

* Previous treatment with etanercept, antibody to TNFα, or other TNFα inhibitors
* Received investigational drugs within 6 months of the baseline visit
* Received intra-articular hyaluronic acid injections within 4 weeks of the baseline visit
Biomonitoring and Cardiorenal Syndrome in Heart Failure(BIONICS-HF) Trial

The purpose of this study is to evaluate the ability of a non-invasive monitor that measures how much fluid is in the body as well as various blood tests for their ability to predict worsening kidney function in patients with heart failure.

Our specific aims are to:

1. Evaluate the individual and collective ability of pro-B type natriuretic peptide (NT-pro-BNP), soluble (s)ST2, neutrophil gelatinase-associated lipocalin (NGAL), and bioelectrical impedance vector analysis (BIVA) for predicting in-hospital worsening renal function (WRF) in patients evaluated in emergency department (ED)with acutely decompensated heart failure (ADHF)compared to a model of clinical variables alone.
2. Evaluate the individual and collective ability of NT-proBNP, sST2, NGAL, and BIVA for identifying the correct cause of in-hospital WRF in patients evaluated in the ED with ADHF.
3. Evaluate the individual and collective ability of NT-pro-BNP, sST2, NGAL, and BIVA for predicting outcomes (all-cause death, all-cause re-hospitalization, initiation of renal replacement therapy by 180 days) in patients with ADHF.

Eligibility Criteria:
Inclusion Criteria:

* Dyspnea thought to be due to ADHF
* NYHA class III or IV symptoms

Exclusion Criteria:

* renal failure requiring renal replacement therapy rior to enrollment
* unable or unwilling to participate
* \> 6 hours from first dose of intravenous diuretic