cyrilzakka/clinical-trials huggingface dataset:
Prognostic Value of Neutrophil-to-lymphocyte Ratio (NLR) on Rectal Cancer Patients

We explored the relationship between NLR and grade 3 or higher treatment related small bowel toxicity and treatment outcome of patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy (IMRT).

Gender, age, stage of disease, and pathologic factors were retrospectively obtained from electronic patient records. Staging was determined according to the classification established by the American Joint Committee on Cancer (AJCC, 7th edition).Pelvic magnetic resonance imaging (MRI) were used for pretreatment staging. All patients enrolled in this study were treated with intensity modulated radiotherapy (IMRT) concurrent with capecitabine (1600 mg/m2/d, administered twice daily for two weeks) before or after curative resection. The mean radiation dose was 50 Gy with daily fraction of 2.0 Gy.

Acute treatment toxicity was scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 3.0) and late toxicity was classified according to the Late Effects in Normal Tissue-Subjective, Objective, Management and Analytic (LENT-SOMA) system.

After the whole treatment procedure, all patients were subjected to a follow-up every three months for the first two years, every six months for the next three years, and every year thereafter. Physical examinations, routine blood test, serum carcinoembryonic antigen (CEA) and Cancer Antigen 19-9 (CA-199) level were checked at each follow up. Chest, abdominal CT scan and total colonoscopy were performed annually except the suspicion of tumor recurrence.

Overall survival (OS) time was defined from the date of completion of treatment to death from any cause and progression-free survival (PFS) time was defined as the time from the date of completion of therapy to the date of local recurrence or distant metastasis or death. Patient follow-up was lasted until death or the cutoff date of January 2017.Blood sampling reports from each enrolled patient were obtained within seven days before treatment. White blood cell count, neutrophil, lymphocyte and platelet counts were examined. The NLR was calculated as the absolute neutrophil count divided by the absolute lymphocyte count using baseline blood test results.

Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced rectal cancer who received neoadjuvant or adjuvant chemoradiotherapy at our hospital were enrolled in this study.

Exclusion Criteria:

* Patients with coexistent autoimmune diseases, infectious diseases, and lacking baseline blood test records were excluded from this study
Early Mobilisation in Intensive Care Unit : Interest of Cyclo-ergometry in Patients With Septic Chock

Cycloergometer is a validated method for different care. This kind of device allow passive and active care for patient. The interest of cycloergometer for patient hospitalized in Intensive Care Unit for Sepsis has never been demonstrated.

The main objective of this study is to determine the impact of early mobilization by cyclo-ergometer in association with standard physiotherapy, on the ICU length in patients with septic shock

The secondary objectives of this study are to assess the impact of early mobilization by cyclo-ergometer in association with standard physiotherapy on:

1. the duration between hemodynamic stability\* and the removal of sedation
2. the duration between the removal of sedation and ICU discharge
3. the mechanical ventilation duration (invasive and noninvasive)


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in ICU
* Septic shock diagnosed more than 24 hours before inclusion
* Patient hemodynamically stable, before the 72th hour following the diagnosis of septic shock
* Mechanical ventilation by tracheal intubation
* Patient sedated with a RASS score inferior or equal to -2
* Age ≥ 18 years
* BMI ≤ 40 kg / m²
* Informed patient having signed the consent
* Effective contraception in women of childbearing age (pregnancy test by B-HCG will be done; for menopausal women, a diagnosis of confirmation must be obtained).

Exclusion Criteria:

* BMI\> 40kg / m²
* Patient reduced by one or two lower limbs
* Rheumatological pathology, trauma or surgery of the lower limbs, pelvis or spine resulting of any limitations of the range of motions or strict immobilization
* Brain-injured patient and / or medulla injured
* Hemodialysis continues with a femoral catheter without possibility of changing the catheter location
* Moribund patient, Stop or Limitation of Active Therapeutics' decision
* Contraindications to standard physical therapy or the cyclo-ergometer
* Untreated orthopedics: deep vein thrombosis of the member concerned
* Dermatological: severe lesions or complex dressings in the sector concerned
* Patient with ExtraCorporeal Membrane Oxygenation (ECMO)
* Pregnant or breastfeeding women
* Patient participating in another trial with the same main objective
Use of Ketamine Prior to Cardiopulmonary Bypass in Children

To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain.


Eligibility Criteria:
Inclusion Criteria:

* less than one year of age
* undergoing cardiac surgery for repair of ventricular septal defect
* requiring cardiopulmonary bypass
* not requiring retrogrades cerebral perfusion

Exclusion Criteria:

* Downs Syndrome
Study to Find Out the Appropriate Initial Dose of the Anticoagulant Drug Phenprocoumon

Oral anticoagulation is often initiated in hospitalized patients. Although the therapeutic range of phenprocoumon is narrow, the individual drug demands unfortunately vary greatly between persons. Our group recently developed two dosing algorithms for the initiation of anticoagulation based on clinical predictors such as age, gender, body weight and laboratory values.

The aim of the proposed study is to prospectively evaluate the efficacy and safety of these two algorithms in medical and orthopedic inpatients, as well as in a group of outpatients and possibly in a geriatric collective.

Background:

The presently available oral anticoagulants have a very narrow therapeutic range but the interindividual demands to achieve therapeutic anticoagulation (=loading dose) varies greatly. Overanticoagulation is a major cause of bleeding complications, whereas insufficient anticoagulation is associated with thromboembolic disease and possibly prolonged hospital stay. A model to predict the loading dose with phenprocoumon (Marcoumar®) is therefore highly desirable.

In a retrospective analysis of 300 inpatients (152 medical, 148 orthopedic patients) of the Cantonal Hospital of St. Gallen our group identified clinical predictors for the loading dose of phenprocoumon and two dosing algorithms were developed (Good AC, Henz S. A clinical algorithm to predict the loading dose of phenprocoumon. Thromb Res. 2007;120(6):921-5.).

In order to validate the safety and efficacy of these dosing algorithms we plan this prospective interventional study with three equally sized arms: dosing according to algorithm 1, dosing according to algorithm 2 or dosing according to the estimate of the physician (control).

Eligibility Criteria:
Inclusion Criteria:

* Consecutive inpatients of the internal medicine and the orthopedic surgery department of the Cantonal Hospital of St. Gallen needing new onset oral anticoagulation

Exclusion Criteria:

* Patients with prior oral anticoagulation with coumarines within less than 6 weeks,
* patents, who received vitamin-K supplements within less than one week before the onset of oral anticoagulation,
* patients with liver cirrhosis other than Child A,
* pregnant women (pregnancy has to be excluded in women of childbearing age),
* patients younger than 18 years, and
* patients unwilling or unable to give informed consent
* patients with (clinically diagnosed) dementia and
* persons with insufficient German, French, Italian or English language skills)
The ABC Trial Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery? A Single Centre Pilot Study

This study is a single centre pilot for a randomized trial comparing all-blood cardioplegia to more dilute 4:1 blood cardioplegia during cardiac surgery. The hypothesis is that all-blood cardioplegia will be associated with less blood transfusion and better cardiac function.

This is a single centre randomized, double blind, 2 arm, parallel group pilot study comparing all-blood cardioplegia to 4:1 blood cardioplegia in patients undergoing cardiac surgery. This pilot study will support the design of a larger multicentre trial.

Subjects undergoing cardiac surgery will be randomized to receive either standard of care (4:1) or all-blood cardioplegia for myocardial protection. Neither of these cardioplegia approaches would be considered investigational. Each is in use at numerous cardiac surgical centres around the world. The cardioplegia will be delivered using the Quest medical MPS system which is a Health Canada Approved device.

Clinical endpoints will be evalauted (rate of blood transtransfusion, ICU stay, etc...). In a subset of subjects who meet specific criteria, ventricular function will be evaluated in the operating room using the CD Leycom INCA conductance catheter system.

Eligibility Criteria:
Inclusion Criteria:

* patients (male and female) undergoing isolated coronary artery bypass grafting,
* isolated aortic or mitral repair or replacement, and
* combined aortic or mitral valve repair or replacement and
* coronary bypass grafting

Exclusion Criteria:

* reoperation,
* endocarditis,
* dialysis dependant renal failure,
* pre-operative ECMO or LVAD support,
* contraindication to blood transfusion (ie. Jehovah's Witness), and
* use of irreversible anti-platelet (other than ASA) and anticoagulant agents within 48h (ie. plavix, dabigitran, GpIIb/IIIa inhibitors, argatroban).
Functioning in Individuals with Cervical Radiculopathy After Posterior Cervical Decompression

Compression on structures, as spinal nerves, in the cervical spine can cause cervical radiculopathy which leads to pain, disability, and reduced quality of life for the affected individual. Cervical foraminotomy with our without laminectomy are common posterior decompression surgical techniques for treating cervical radiculopathy. There is a lack of knowledge regarding function in patients with cervical radiculopathy after posterior cervical decompression.

The aim with this study is to study pain, function, psychosocial factors, and health related quality of life after posterior cervical decompression in patients with cervical radiculopathy.

This is a prospective multicenter longitudinal observational cohort study with follow-up at three, 12- and 24 months postoperative. A total of 154 individuals scheduled to undergo foraminotomy with our without laminectomy due to cervical radiculopathy will be included. Primary outcome is neck-specific function measured with the Neck Disability Index. Data will be collected preoperatively and at three, 12 and 24 months with electronic questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Cervical radiculopathy, confirmed by MRI images (or alternative neuroradiological imaging if MRI contraindicated) compatible with clinical findings of nerve root compression (neurological examination performed by a neurosurgeon/orthopedic surgeon)
* Posterior cervical decompression as foraminotomy with our without laminectomy
* At least 3 months of persistent arm pain
* Age 18-75 years

Exclusion Criteria:

* Nurick score 2 or more (to exclude individuals with moderate to high myelopathy)
* Previous surgery of cervical spine
* Previous fracture or dislocation of the cervical spine
* Malignancy or benign spinal tumor (eg, neuromas)
* Spinal infection
* Previous spondylodiscitis
* Servere mental disorder
* Known alcohol or drug abuse
* Lack of ability to write/comprehend/express oneself in Swedish
Effect of Chlorogenic Acids on the Human Vasculature

This study evaluates effects of different doses of chlorogenic acids on vascular health.

It has been suggested that consumption of food rich in chlorogenic acids can help to improve vascular health, measured by flow mediated dilation.

Eligibility Criteria:
Inclusion Criteria:

1. Male or postmenopausal female healthy volunteers aged 45-65 years old
2. Willing and able to sign written informed consent prior to trial entry
3. Healthy as determined by the medical history and physical examination

Exclusion Criteria:

1. Premenopausal women
2. Current smokers
3. Abnormal blood pressure, defined as follow: systolic \<90 or \>140 mmHg and diastolic \<60 or \>90 mmHg
4. Regular consumption of cholesterol-lowering medication
5. Regular consumption of antihypertensive medication
6. Regular consumption of any vasoactive medication that cannot be discontinued for at least 4 half-lives before the FMD assessment
7. Any food allergies
8. Any intakes of multivitamin-tablets and other supplemental compounds within 10 days of the study start and throughout the study
9. Inability to refrain from coffee/tea and alcohol consumption for 12 h prior to study visits
10. Acute or chronic major psychiatric illness or other major illness that in the opinion of the investigator would make the subjects' participation in the study unsafe or prevent them from fully complying with the study procedures
11. Use of medication to treat psychiatric illness (depression) within 3 months prior to the study
12. Recent significant weight loss or gain (\>6% of body weight) in the past 3 months
13. Body mass index (BMI) outside 18-32 kg/m2 range
14. Alcohol intake \> 280g/week (21-28 glasses per week)
Development & Pilot RCT of an Online Peer Support Program for Family Caregivers of Ventilator-Assisted Individuals

Ventilator assisted individuals (VAIs) living at home are frail and generally cannot perform most daily activities. Although these individuals prefer to live at home, the family members who care for them often experience stress and poor health. Peer support can mitigate health declines by decreasing caregivers' isolation/stress and increasing their sense of control. However, no peer support programs are designed to meet these caregivers' complex and unique needs. Online support delivery is especially beneficial for caregivers given the geographic and time limitations they face. The proposed research aims to develop and conduct an RCT of online peer support program for VAI caregivers. A group of caregivers will be trained to act as peer mentors. This training program will be evaluated for its impact on caregivers' mentoring abilities. At the end of the 12-week program, caregiving participants will be asked about the online delivery of the program, how helpful/satisfactory it was, and if it affected their health and well-being. The health outcomes of the control and intervention group will be compared. This peer support program can improve the well-being of caregivers and allow them to better care for their family members.


Eligibility Criteria:
Inclusion Criteria:

1) age = 18 years; 2) primary family caregiver for a VAI living in the community; 3) able to speak and read English; and 4) access to a computer and a reliable internet connection.

Exclusion Criteria:

1) currently experiencing severe depression as indicated by a score of 40 or higher on the Centre for epidemiological studies short depression scale (CES-D 10).
Variation in Acute Appendicitis During COVID-19 Pandemic in Italy

retrospective observational study of variation in incidence and clinical presentation of appendicitis during the pandemic in northern Italy, compared with the same period in the previous 2 years.


Eligibility Criteria:
Inclusion Criteria:

* acute appendicitis

Exclusion Criteria:

* other diagnosis
A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease

People with Fabry Disease have an alteration in their genetic material (DNA) which causes a deficiency of the alpha-galactosidase A enzyme. Fabrazyme (agalsidase beta) is a drug that helps to break down and removes certain types of fatty substances called "glycolipids". These glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not present, or is present in small quantities. The build up of glycolipid (globatriaosylceramide or GL-3) levels in these tissues in particular is thought to cause the clinical symptoms that are common to Fabry disease. This study analyzed the safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease that previously participated in the AGAL-008-00 (NCT0074984) study.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have successfully completed the previous double-blind study AGAL-008-00 (NCT00074984)
* Patients must provide written informed consent prior to study participation
* Female patients of childbearing potential must have a negative pregnancy test prior to each dosing and all female patients must use a medically accepted form of contraception throughout the study

Exclusion Criteria:

* The patient was unable to complete AGAL-008-00 (NCT00074984)
* The patient has undergone kidney transplantation or is currently on dialysis
* The patient has diabetes mellitus or presence of confounding renal disease
* The patient has a clinically significant organic disease or an unstable condition that precludes participation
* The patient is unwilling to comply with the protocol requirements
Clinical Evaluation of Implants Restored With Advanced Lithium Disilicate Screw-retained Crowns

This is a prospective observational clinical trial to evaluate the clinical performance of the Cerec Tessera prosthetic assembly on implants restored with chairside CAD/CAM-generated crowns. This investigation is intended as a Post Market Clinical Follow-up study for the product Cerec Tessera and its prosthetic assembly for implants, which will serve as a life-cycle approach to safety, backed up by clinical data and post-market monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-75 years.
* Willing and able to sign and date the informed consent form and HIPAA form.
* Have a single implant that has been successfully osseointegrated and deemed ready for restoration by the surgeon placing the implant.

(A maximum of two single dental implant restorations per subject will be restored.)

* Have a single implant that is acceptable to be restored with a digital workflow using the CEREC system.
* Have a single implant to be restored with a screw retained advanced lithium disilicate crown.
* Have a single implant with at least one adjacent tooth contact and with an occlusal contact.

Exclusion Criteria:

* Not willing to participate in the clinical investigation or not able to understand the content of the clinical investigation.
* Unlikely to be able to comply with clinical investigation procedures according to the Principle Investigator's/Co-investigator's judgement.
* Unable or unwilling to return for recall appointments for a period of 5 years.
* Severe non-compliance to Clinical Investigation Protocol as judged by the PI or Co-investigators.
* Women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times.
* Previous enrollment in the present clinical investigation.
* Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona personnel and from the clinical investigation site).
Vitrification Versus Spontaneous Conception and Slow- Rate Freezing

Great scientific effort has been made to improve practical as well as economical procedures of modern assisted reproduction.

In the last years a shift from the well established method of slow-rate freezing to vitrification of 2PN zygotes and embryos could be observed. Like any other method of cryopreservation, the outcome of vitrification will be affected by several factors related to technique itself, its practical management and patient characteristics.

The investigators want to investigate the influence of vitrification on the outcome of of 2PN oocytes, pregnancy and infant health.

A Comparison between a cohort of spontaneous conceived children and children of vitrified and slow- cooled 2PN oocytes is planned.


Eligibility Criteria:
Inclusion Criteria:

* cryopreservation (vitrification and slow- rate freezing) between 1998 - 2010
* Treatment in Lübeck University
* Delivery in Lübeck University
* Positive informed consent

Exclusion Criteria:

* Negative informed consent
A Study to Derive Normative Distribution of CIMT and to Determine Its Correlation With Cardiovascular Risk Factors

This non-interventional, prospective, multi-centric, cross-sectional study is aimed to obtain the distribution of measurements of CIMT in Indian subjects and will involve approx. 30 investigative sites from all over the country. Each investigative site will be expected to enrol 50 subjects and Carotid intima-media thickness (CIMT) values will be taken for each individual as described in the protocol.

All the procedures could be completed in a single day, however due to any reason any study variable is not taken subject may be asked to come back for a second visit within 7 days of the first visit.

A Study to derive normative distribution of CIMT and to determine its cOrrelation with cardiovascular Risk factors in asymptomatic nationwidE Indian population. (SCORE India)

Eligibility Criteria:
Inclusion Criteria:

* Provision of subject informed consent
* Female or male aged 30 years and over

Exclusion Criteria:

* Subjects with established cardiovascular event
* Intake of lipid lowering drug in the past 3 month
* Subjects with known hypersensitivity to carotid bulb
* Pregnant or lactating women
System for Determining Ideal Drug Doses for ADHD - Stages 1 and 2

The goal of this study is to create a formal, quantitative methodology to determine what is the most beneficial dose of Central Nervous System (CNS) stimulant (Ritalin, methylphenidate) to improve cognitive and behavioral function of children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) individually. If successful, it will change the way in which the dose of CNS stimulant for treating ADHD is determined for children in need of therapeutic intervention. The project will be focused on developing the necessary methodology to analyze the children's data with the drift-decision model (DDM), and to develop the required technology, i.e., a computer game with which to measure cognitive/behavioral function and its validation with eye-tracking measurements.


Eligibility Criteria:
Inclusion Criteria:

* 8-12 years of age;
* Accompanied by caregiver (parent or legal guardian);
* Able to understand and speak English;
* Able to read basic English;
* No counseling or current/past history of psychiatric illness, as confirmed by the Child Behavior Checklist (CBCL) and Conner's rating scale

Exclusion Criteria:

* Active psychosis or suicidality
* History of primary psychotic disorder (e.g., schizophrenia) or bipolar disorder
* Recent (past 2 weeks) substance abuse or dependence
* History of brain damage or significant developmental delay
* Unstable medical condition such as newly diagnosed Type I Diabetes or Rheumatoid arthritis
* Use of oral steroids
* Participation in the last 30 days in a clinical study involving an investigational drug
* Current use of a psychotropic medicine