cyrilzakka/clinical-trials huggingface dataset:
Caprini Score in Venous Surgery: a Prospective Cohort Study

The aim of the study is to make a validation of Caprini score in patients undergoing varicose veins surgery, especially endovascular procedures (endovascular laser treatment - EVLT, radiofrequency ablation - RFA, ultrasound-guided foam sclerotherapy - USFS) and to identify patients with elevated risk of postoperative venous thromboembolism (VTE) who will benefit from prophylactic anticoagulation.

A prospective cohort study based on the platform of Ongoing Registry of Treatment of Chronic Venous Diseases (NCT03035747). The study will enrol adult patients undergoing any kind of varicose veins surgery with and without any prophylaxis. The patients should be examined for venous thromboembolic complications during 2-4 weeks after the procedure with mandatory duplex ultrasound.

The study will provide following information:

* the rate of asymptomatic DVT after varicose veins surgery
* the rate of symptomatic VTE after varicose veins surgery
* the rate of thermal-induced thrombosis (EHIT) after endovenous thermal ablation
* the ability of Caprini scores to predict VTE after varicose veins surgery
* identification of patients with high risk of VTE who will benefit from prophylaxis, especially with anticoagulation

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* any kind of varicose vein surgery
* follow up for 4 weeks after the procedure
* examination for VTE at 2-4 weeks after the procedure, including duplex ultrasound

Exclusion Criteria:

- lost for follow-up during 4 weeks
A Real-world Study of Chidamide in Combination with PD-1/PD-L1 Antibodies and Anti-angiogenic Agents in Advanced MSS Colorectal Cancer

This is an observational , multicenter, real-world study aimed at evaluating the efficacy and safety of the combination of immune checkpoint inhibitors, chidamide and antiangiogenic agents in Microsatellite Stable advanced colorectal cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Aged≥18 years
2. Histology-confirmed metastatic CRC (mCRC);
3. ECOG 0\~2
4. At least one efficacy evaluation
5. Life expectancy of at least 3 months.

Exclusion Criteria:

1. Lack of follow-up data.
2. Chidamide stopped after less than two cycles.
3. Serious comorbidities that interfere with the efficacy or safety analysis
Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease

The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease.

Anti-IP10: Anti Interferon-inducible ligand 10

Eligibility Criteria:
Inclusion Criteria:

* Adults subjects with confirmed Crohn's Disease (CD) for at least 3 months
* Moderate to severely active CD as defined by Crohn's Disease Activity Index (CDAI) 220 to 450
* In the past have had insufficient response and or intolerance to ≥ 1 of the conventional therapy (immunosuppressants, corticosteroids and/or approved biologic therapy)

Exclusion Criteria:

* Ulcerative colitis (UC) or indeterminate colitis
* Short bowel syndrome
* Known stricture or noninflammatory stenosis leading to symptoms of obstruction
* Current stoma or current need for colostomy or ileostomy
Long-Term Patient Satisfaction of Facial Aesthetic Treatment With BOTOX®

This is an observational study assessing patient satisfaction following at least 5 years of BOTOX® treatment for glabellar lines.


Eligibility Criteria:
Inclusion Criteria:

* At least one BOTOX® treatment for facial wrinkles (glabellar lines) per calendar year for ≥5 years

Exclusion Criteria:

* Received botulinum toxin formulations other than BOTOX®
Multi-Reader, Multi-Case, Cross-Over, Retrospective Study to Evaluate Effectiveness of Lunit INSIGHT DBT

This study aims to evaluate Effectiveness of Lunit INSIGHT DBT in the assistance of detection and diagnosis of breast cancer during 3D mammography interpretation

The primary objective of the trial is to evaluate the effectiveness of Lunit INSIGHT DBT in the assistance of detection and diagnosis of breast cancer by comparing the clinical performance of radiologists before and after using Lunit INSIGHT DBT in their DBT reading and secondarily examining the use of Lunit INSIGHT DBT to shorten DBT reading time.

Eligibility Criteria:
Inclusion Criteria:

\[For All Subject Groups\]

* Female
* 22 years old or older

\[For 'Control (Non-cancer)' Group\]

* Negative Cases Interpreted as BI-RADS 0 (Assessment Incomplete) or BI-RADS 1 (Negative) with no cancers on the DBT exam and confirmed as BI-RADS 1 (Negative) on the further diagnostic imaging (e.g., MMG, DBT, MRI, CT and Ultrasound) taken at least after 1 year of the DBT exam.
* Benign Cases Interpreted as BI-RADS 0 (Assessment Incomplete) or BI-RADS 2 (Benign) with a visible lesion on the DBT exam and confirmed as BI-RADS 2 (Benign) on the further diagnostic imaging (e.g., MMG, DBT, MRI, CT and Ultrasound) taken at least after 1 year of the DBT exam without a further breast biopsy.

Or for the biopsy-proven benign exams, interpreted as BI-RADS 0 (Assessment Incomplete), BI-RADS 3 (Probably Benign), 4 (Suspicious) or 5 (Highly Suggestive of Malignancy) with a visible suspicious lesion for breast cancer on the DBT exam but confirmed as benign through subsequent biopsy conducted within following 1 year of the DBT exam.

\[For 'Condition (Cancer)' Group\] Interpreted as BI-RADS 0 (Assessment Incomplete), BI-RADS 3 (Probably Benign), 4 (Suspicious) or 5 (Highly Suggestive of Malignancy) with a visible suspicious lesion for breast cancer on the DBT exam and confirmed as a cancer (malignant) through the subsequent biopsy conducted within following 1 year of the DBT exam.

Exclusion Criteria:

* Previous breast cancer
* Previous vacuum-assisted biopsy, surgical biopsy or surgery in breast
* Presence of a breast implant or pacemaker on the required images: 4 views (RCC, RMLO, LCC, LMLO) images of Screening or diagnostic DBT exams with a FFDM (Full-Field Digital mammography) image or with a synthetic 2D image
Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+)

The study will assess the number of patients who become asymptomatic from clinical signs of COVID19 and will assess the efficacy of Hydroxychloroquine (HCQ) and Azithromycine effects on paucisymptomatic patients with ou without co-morbidities


Eligibility Criteria:
Inclusion Criteria:

* confirmed COVID19 (+)
* Qt\<500ms
* no severity criteria
* pauci-symptomatique patients
* signed consent form

Exclusion Criteria:

* no confirmed patient COVID19
* severity criteria
* known allegies to macrolides and HCQ
* Treated with HCQ within 1 month prior to inclusion
* hepatitis insufficiency
* Renal insufficiency
* treatment no indicated with azithro and HCQ
* hypovolemia
* complete brach block
* retinopathia
* psoriasis
* pregnancy or breastfeeding
Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.

Cyclin-dependent kinase (CDK) 4/6 inhibitors are a class of agents recently introduced in the clinic for the treatment of advanced hormone receptor-positive (HR+) and HER2-negative (HER2-) BC. Palbociclib, ribociclib and abemaciclib have all been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency among other regulatory bodies

Several factors are thought to influence the variability of treatment efficacy and toxicity, including organ function, comedications, hormonal status, body weight, age, comorbidities, etc. Among them, single nucleotide polymorphisms (SNPs) as rs1128503, rs2032583 are attracting huge interest to address the interindividual variability in drug response, whether in terms of efficacy or safety

Eligibility Criteria:
Inclusion Criteria:

* 1. Adult patients (≥18 years). 2. Confirmed diagnosis with MBC. 3. HR-positive/HER2-negative MBC as ascertained by immunohistochemistry (IHC) or fluorescence in situ hybridization in primary or metastatic tissue samples.

  4. Patients with primary or secondary resistance to endocrine therapy. 5. Patients with Eastern Cooperative Oncology Group (ECOG) 0 or 1. 6. Scheduled to receive Palbociclib in first- or second-line metastatic setting.

Exclusion Criteria:

1. Prior exposure to fulvestrant or everolimus.
2. Patients with uncontrolled brain metastases or symptomatic visceral spread who are at risk of life-threatening complications.
3. Patients refusing to sign the written informed consent.
Impact of Global Care of the Pain at Chronic Painful Patients Affected by Cystic Fibrosis

The purpose of this study is to evaluate the impact of the global approach to the pain in cystic fibrosis patients with chronic or intermittent pain. The patients will receive in addition to an usual pharmacological and psychological management, sophrology sessions at home. The results of this study will provide a new strategy of management of the patient's pain.

The majority of cystic fibrosis patients have chronic or intermittent pains. These pains have important consequences on the quality of life. Currently, the treatment is essentially pharmacological (essentially paracetamol) but it is not enough in presence of of visual analogue scale (VAS) \>4. In the study, the patients will receive in addition to an usual pharmacological and psychological management, sophrology sessions at home. The sophrology is a dynamic method of physical and psychical relaxation. This aims are to decrease the pain, to decrease the anxiety and to improve the everyday life. This study will provide a new global strategy of the management of the patients' pain.

Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis patients defined by a test sweat and / or 2 pathogenic mutations
* Patients over 10 years
* Patients with pain symptoms (VAS\> 4) recurrent (\> 4 episodes / month) or permanent since more than 6 months
* Agreement of patients, and parents (for children) for sophrology sessions conducted at home.
* Patient affiliated to social security

Exclusion Criteria:

* Transplant patients or placed on a waiting list transplantation
* Patients had a patient-support by techniques hypnosis or relaxation therapy, during or within 3 months.
* Patients enrolled in another research interventional protocol.
* Women without contraception or pregnant.
Effect of Erythropoietin on the Incidence of Acute Kidney Injury Following Complex Valvular Heart Surgery

Acute kidney injury (AKI) frequently occurs after cardiac surgery using cardiopulmonary bypass (CPB). Recombinant human erythropoietin (rHuEPO) is known to provide organ protection against ischemia-reperfusion injury through its anti-inflammatory properties. The aim of the present study was to investigate the effect of a single preoperative bolus of EPO on the incidence of AKI following complex valvular heart surgery in a randomized, controlled and double-blind trial.


Eligibility Criteria:
Inclusion Criteria:

* preoperative risk factors for AKI and scheduled for complex valvular heart operations
* Enrolled criteria for high risk of AKI were patients with more than 2 of bellows: female, serum creatinine \>1.2 mg/dl, preoperative A-fib, GFR \< 60 ml/min, NYHA class IV, HTN, DM, age \> 65 years, peripheral vascular disease.
* Complex valvular heart operations were defined as double-valve surgery, combined valve and coronary artery bypass grafting procedures, Bentall operation, combined mitral valve surgery and tricuspid annuloplasty or reoperation.

Exclusion Criteria:

* Patients with preexisting uncontrolled hypertension (diastolic blood pressure \> 100 mmHg), immunosuppression, history of thromboembolism, malignant disease, seizure, liver dysfunction, renal impairment (serum creatinine \> 2 mg/dL), and drug or alcohol abuse were excluded.
Cerebral Oximetry in Lower Body Negative Pressure

The study aims to describe hemodynamic effects of lower body negative pressure (LBNP).

1. If and how changes in cerebral oxygen saturation (StO2) measured by near infrared spectroscopy (NIRS) relate to changes in blood flow in the carotid arteries during progressive LBNP.
2. If and how mean systemic filling pressure (MSFP) can be measured by brief occlusion of blood flow to an arm and if this relates to LBNP-level.
3. If and how pulse pressure variations and photoplethysmographic amplitude variations during positive expiratory pressure (PEP) and continuous positive airway pressure (CPAP) relate to LBNP-level.

20 healthy volunteers will be included. The study protocol consists of two parts.

1. LBNP is applied stepwise (20 mmHg increments). At each LBNP-level, after 2 min stabilization, blood flow in internal and external carotid arteries is measured. Thereafter, MSFP is measured. LBNP is applied to -80 mmHg, but terminated sooner if the subject experiences signs of decompensation.

   Changes in cerebral StO2 will be related to relative changes in blood flow in the carotid arteries. After these measurements, blood flow to one arm will be occluded for 30 s. Venous pressure measured in an antecubital vein approximates MSFP. This will be related to volume status (LBNP-level and stroke volume reduction).
2. LBNP is applied stepwise (20 mmHg increments). At each LBNP-level, after 2 min stabilization, PEP and CPAP are applied at 0, 5 and 10 cmH20. LBNP is applied to -80 mmHg, but terminated sooner if the subject experiences signs of decompensation.

Flow in carotid arteries is measured by ultrasound/Doppler. Skin blood flow in the forehead measured by laser Doppler flowmetry and transcutaneous oxygen saturation.

If possible, blood flow velocity in a. cerebri media will be measured by transcranial Doppler.

Central venous pressure will be approximated by measuring pressure in the left subclavian vein ("half-way" catheter).

Cardiac stroke volume will be measured by suprasternal Doppler. Expiratory carbon dioxide (CO2) will be measured and recorded. Acral skin photoplethysmography performed using proprietary and custom-made photoplethysmographs.

Arterial blood pressure approximated by finger volume-clamp method.

The measurements above will be used for analyses of possible physiological mechanisms and post-hoc analyses.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer (informed consent)

Exclusion Criteria:

* Disease/physical condition limiting normal physical activity or requiring medication (except allergies/contraceptives)
* History of syncope (except with obvious vasovagal etiology)
* Cardiac arrhythmia
* Pregnancy
* Skin infections in the elbow crease
Cardiac and Renal Disease Study (CARDS)

To examine the epidemiology of renal disease and its relationship to cardiovascular disease.

BACKGROUND:

Mild-to-moderate chronic renal insufficiency (CRI) has been reaching epidemic proportions in the United States. Studies relating mild-to-moderate chronic renal insufficiency and cardiovascular risk were limited and inconsistent. Although much had been learned about the natural history and adverse outcomes associated with end-stage renal disease (ESRD), there was little specific information regarding risk factors for the development or progression of renal disease.

The study was initiated in response to a Request for Applications entitled "NHLBI Innovative Research Grant Program" released in July, 2001. The purpose of the initiative was to support new approaches to heart, lung, and blood diseases and sleep disorders that used existing data sets or existing biological specimen collections whether obtained through National Heart, Lung, and Blood Institute support or not.

DESIGN NARRATIVE:

The population-based study used data on an ethnically diverse large cohort of male and female health plan enrollees with extended follow-up. The study evaluated: a) whether baseline and decline in renal function over time were independent predictors of coronary heart disease (CHD), stroke, heart failure and peripheral vascular disease; b) effect modifiers of these relationships,including baseline hypertension and diabetes status. The study determined whether baseline and increase over time in blood pressure level (as well as prevalent and incident hypertension) were predictive of the subsequent risk of ESRD after adjusting for diabetes and for baseline serum creatinine, proteinuria and hematuria. The study also examined other potential predictors of ESRD including demographic factors (race/ethnicity, level of education) total cholesterol level, family history of renal disease, body mass index, sagittal abdominal diameter, cigarette (as well as cigar and pipe) smoking, coffee intake, alcohol consumption, family history of renal disease and self-reported occupational exposures. The study used existing longitudinal data resources at the Northern California Kaiser Permanente Division of Research and available patient-level cross-linkage with the US Renal Data System end-stage renal disease registry to obtain comprehensive renal and cardiovascular outcomes.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Effect of Non-invasive Neurostimulation on Variability OF HEART RATE IN PATIENTS WITH HEART FAILURE.

This study is a clinical trial, and may also be referred to as a "before and after" study, in which all subjects receive the same treatment and their condition is checked before initiation and after various times of treatment. This study will be carried out at the Laboratory of Physiotherapy in Cardiorespiratory Research, located in the building of the postgraduate course in physiotherapy at the Health Sciences Center (CCS) of the Federal University of Parahyba (UFPB), from May 2023 to May 2020. 2024. After screening, patients will undergo assessment and anthropometric measurements. Subsequently, interventions will be carried out

The patients will perform three sessions of HD-TDCS (stimulation, inhibition and Shan) of twenty minutes with an intensity of three milliamps in the left temporal cortex. Before and after each session, patients will perform the six-minute walk test. Heart rate variability (HRV) will be evaluated throughout the protocol through Holter (3-channel). At the end, the perception of exertion and the level of dyspnea of the patient, distance covered and blood pressure will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of heart failure;
* over eighteen years old;
* classified in functional class II and III of the New York Heart Association.

Exclusion Criteria:

* Patients with neurological or pulmonary diseases;
* Patients with cognitive alterations that make it impossible to execute commands;
* with physical limitations that prevent the performance of the exercise protocol.
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccinations in Spain.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 2-month-old infants
* Available for the entire study period

Exclusion criteria:

* Previous vaccination with any vaccine before the start of the study
* Known contraindication to vaccination
Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.

The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in children with type 1 diabetes in a diabetes camp.

The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy to reduce time spent in hypoglycemia

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.

The investigators aim to conduct a randomized three-way cross-over trial comparing single hormone closed-loop strategy, dual-hormone closed-loop strategy and the conventional pump therapy. The investigators aim to compare the three interventions for 3 consecutive nights in children with type 1 diabetes in a diabetes camp.

Eligibility Criteria:
Inclusion Criteria:

* Males or females between the 8 and 17 years of old.
* Clinical diagnosis of type 1 diabetes for at least one year. The subject will have been on insulin pump therapy for at least 3 months.
* HbA1c ≤ 11.0%.

Exclusion Criteria:

* Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
* Severe hypoglycemic episode within two weeks of inclusion in the study. A severe hypoglycemic episode is defined as loss of conscience, seizure or a hospital emergency visit.
* Current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). Stable doses of inhaled steroids are acceptable.
* Known or suspected allergy to the trial products.
* Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
* Failure to comply with team's recommendations (e.g. not willing to use trial pump, etc).
The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.

The purpose of this study is to determine whether anti-inflammatory treatment with adalimumab (Humira) reduces endothelial activation in blood vessels in patients with active rheumatoid arthritis. Markers of endothelial activation are assessed in muscle tissue before treatment and after 3 months, and related to other biomarkers and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of rheumatoid arthritis
* Fulfillment of the American College of Rheumatology 1987 criteria for rheumatoid arthritis
* Active disease despite treatment with at least one disease modifying anti-rheumatic drug
* Treatment with adalimumab indicated according to the the patient's rheumatologist
* At least six swollen joints in 28-joint index
* CRP \> 8 mg / L within the last three months

Exclusion Criteria:

* Treatment with anti-TNF drugs in the last three months
* Treatment with intravenous corticosteroids within fourteen days
* Ongoing treatment with oral high-dose corticosteroids (equivalent to ≥ 20 mg of prednisolon daily) or completed such treatment less than fifteen days before inclusion
* Severe bleeding disorder
* Extensive or refractory leg ulcers
* Severe peripheral vascular disease
TME Alteration in HER2 Positive Breast Cancer

Evaluate for changes in the tumor microenvironment before/during neoadjuvant chemotherapy and after treatment in patients diagnosed with HER2-positive advanced breast cancer and receiving neoadjuvant cancer therapy and surgery for curative purposes.


Eligibility Criteria:
Inclusion criteria i. Adult patients over 18 years of age ii. Patients undergoing curative treatment including neoadjuvant chemotherapy after confirmation of breast cancer without distant metastases iii. Clinical T stage II-IV patients iv. HER2 positive breast cancer patients

Exclusion criteria If you have other comorbidities that, according to the researcher's judgment, may affect the results of the study