cyrilzakka/clinical-trials huggingface dataset:
Effects of Multipoint Pacing CRT-D on Neurohormonal Activation.

This study will examine the additional clinical benefit conferred by multipoint pacing (MPP) compared to standard CRT over a period of 3 months. Patients will be randomized to MPP ON vs. OFF and followed for a total of 6 months. This includes two crossover periods for each pacing modality (MPP on vs. off).

Cardiac resynchronization therapy (CRT) is limited by a high proportion of non-responders. Pacing activation from multiple separated left ventricular (LV) sites might improve the depolarization pattern, thereby promoting more physiological activation. To explore the effect of MPP on cardiac neuro-hormonal activity, the investigators will enroll approximately 30 patients who already underwent CRT-D implantation with a quadripolar LV lead connected to a device capable of MPP.

This pilot study will have a randomized, double-blind, cross-over design. Patients will be randomized to receive either standard biventricular pacing (MPP-OFF) or MPP (MPP-ON) within 4-6 months following the implantation procedure. Each subject will crossover to the other study group after three months. The baseline evaluation should be acquired prior to the device being programmed to the randomized setting. Repeat evaluations will be performed at the end of each 3 month crossover period.

Participation in this study will last approximately 6 months. Patients, as well as investigators other than the EP physicians, will be blinded to the pacing mode.

Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with a St. Jude Medical CRT-D system with MPP capability
* Patients must be willing and able to sign an appropriate informed consent form and comply with study requirements
* NT pro-BNP levels equal to or greater than 500 pg/ml.

Exclusion Criteria:

* History of stroke, PCI, myocardial infarction or unstable angina pectoris within the last 3 months.
* Atrial fibrillation with noncontrolled heart rate
* Need for intravenous inotropic support for CHF
* Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
* Undergone a cardiac transplantation
* Currently participating in any other clinical investigation
* Life expectancy \< 12 months due to a disorder other than CHF
* Inability to comply with the follow-up procedures
* Patients who are or may potentially be pregnant
SOSteniamoci: Usability Study

The goal of this observational study is to test the usability of the SOSteniamoci platform, culturally adapted from the Lithuanian context, for informal caregivers in Italy.

The main goals were to (1) collect qualitative and quantitative data on usability and (2) identify usability problems. A balanced gender-age sample of 10 individuals meeting the inclusion criteria was consecutively recruited online. The think-aloud testing method, the system usability scale, and an ad hoc semi-structured interview were employed to determine the overall system usability.

The study employed a mixed methods sequential explanatory design approach, comprising the following end-user testing: (1) a phase of collection and analysis of measures of performance employing the think-aloud method, (2) a phase of collection and analysis of quantitative data through the use of a System Usability Scale (SUS) and (3) a phase of collection and analysis of qualitative data through the use of an ad hoc semi-structured interview to further explain the results obtained in the earlier stages.

Ten individuals who showed interest in participating in the SOSteniamoci project by writing to the email address behind the official website (https://www.iterapi.se/sites/sosteniamoci/) were consecutively asked to take part in the usability test based on the inclusion criteria. A balanced gender-age sampling was used to best reflects the heterogeneity of the population.

As a result of the COVID-19 pandemic, all procedures were performed online (completion time: 45 mins, on average). First, each participant received an email with a) the link to the online meeting, including the date and time, and b) the link and access credentials of the SOSteniamoci platform. Before starting the usability test, the researcher provided detailed information about the test procedures and described the purpose of the computer-based self-management system. Participants were then asked to give their online informed consent, provide demographic information, and report on their level of comfort with computers and the Internet.

They were also asked if they had already taken a usability test before. All participants were assigned a unique ID unrelated to their identity. Personal data were linked only to this unique ID and stored in a secure online platform accessible only by the research team and protected by a password.

Eligibility Criteria:
Inclusion criteria:

* age \>18 years
* be able to read and speak the Italian language
* have basic computer skills and Internet access
* own a computer or a compatible device
* having provided informed consent to participate.

Exclusion criteria:

- presentation of self-reported visual, hearing, or cognitive impairments preventing the participant from following the instructions.
Phenomics and Genomics of Clinically Relevant Chronic Postsurgical Pain

The investigators will approach elective cardiac and thoracic surgery patients in the preoperative consultation clinic. Consenting individuals will be administered, before surgery validated pain, psychological and sleep questionnaires. These questionnaires will be repeated at 3, 6 and 12 months postoperatively (PO) to follow up the progression of early PO pain and the transition to chronicity. Participants will define clinically relevant pain by calculating a chronic pain index (CPI). In addition, the investigators will follow the development of acute postsurgical and chronic pain from before surgery up to a year after, extract DNA from blood and contrast the genetic variations of participants with clinically significant chronic pain, to identify variations associated with the development of chronic post-surgical pain.

Most patients who undergo surgery heal within weeks to months and return to their baseline functional status or to an improved level of functioning. However, some patients have pain after surgery which continues. The purpose of this study is to see if there is a relationship between patient's genetic makeup (diseases that are passed on in families) and pain experience following cardiac and thoracic surgeries. This study will look for links between psychological factors, environmental factors and genetic factors in an attempt to uncover the risk for developing chronic post-surgical pain.

This study hopes to determine differences between traditional pain surveys and a basic science approach called "Phenomics" to measure chronic pain response after cardiac and thoracic surgery. Phenomics or Phenomes is the study of physical characteristics, outside influences and biochemical changes (traits or chemical characteristics) and their response to either the environment or genetic changes. Validated pain questionnaires will be administered before surgery, and will repeated at 3, 6, and 12 months postoperatively to follow up the progression of early postoperative pain and the transition to chronicity. In general, the psychological and pain questionnaires are designed to measure the following: anxiety, thoughts, feelings and reactions toward pain and stressful experiences.

In addition, the study will follow the development of acute postoperative and chronic pain from before surgery up to a year after. The investigators will extract DNA from blood and contrast the genetic variations of participants with clinically significant chronic pain, to identify variations associated with the development of chronic post-surgical pain. The blood sample will be drawn at the time of the surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Non- Emergency Cardiac Surgery with Midline Sternotomy OR Thoracic Surgery via VATS or Lateral Thoracotomy
3. Written informed consent to participate in the study

Exclusion Criteria:

1. Patient unable to understand the study protocol
2. History of a psychotic psychiatric disorder
3. Unable to speak English
Factors Associated With Continuation of Exclusive Breastfeeding Until the Post-natal Visit

Breastfeeding promotes the health of mother and her child, and remains the reference in terms of infant nutrition. World Health Organization recommends exclusive breastfeeding for the first six months. This recommended duration is not respected in France with a median duration of breastfeeding in France at 3 months.

The aim is to study factors associated with continuation of exclusive breastfeeding until the post-natal visit.

Eligibility Criteria:
Inclusion Criteria:

* primiparous and multiparous women
* women who have initiate breastfeeding
* women aged 18 and more
* agreeing to participate in the study

Exclusion Criteria:

* women whose newborn has been in intensive care unit
* women with a multiple pregnancy
Real World Evidence on the Use of Medical Cannabis in Pediatrics

CAN-RWE is an observational study that is following 500 children who have authorizations for medical cannabis for two years from across Canada.

Pediatric patients (3 to 17 years) using medical cannabis (MC) for pain, sleep, mood, behaviour, seizures, treatment of cancer, or to manage symptoms related to cancer or cancer-treatment are eligible to join this 24-month study if they have a valid MC authorization.

Following screening, eligible participants will be contacted by the study coordinator. Following informed consent, study participants will record complete outcome measures on pain, sleep, mood (anxiety, depression and positive affect), behaviour, as well as report their cannabis use and indication-specific outcomes as applicable at 3, 6, 12, and 18 weeks, as well as 6, 12, 18 and 24-months.

Eligibility Criteria:
Inclusion Criteria:

* 3 to 17 years
* have a medical document provided by a prescribing health care practitioner (i.e. physician, nurse practitioner, etc.) for the use of medical cannabis
* medical cannabis is authorized for pain, sleep, mood, behaviour, seizures, cancer or cancer-treatment related symptom management
* ability to respond to electronic questionnaires in English

Exclusion Criteria:

* individuals using cannabis for medical purposes without a medical cannabis authorization from a health care provider
* those only using cannabis recreationally
Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet

To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Elevated risk of suicide, in the opinion of the investigator or expert consultant
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
Pharmacokinetics of Tacrolimus in Children

the present study was conducted to assess the population pharmacokinetics of tacrolimus in children with nephrotic syndrome and to use these data to calculate an optimal dosing regimen of tacrolimus for use in these patients.


Eligibility Criteria:
Inclusion Criteria:

* patients have been diagnosed with nephrotic syndrome;
* age range: 1 month to 18 years old
* tacrolimus used as part of regular treatment

Exclusion Criteria:

* expected survival time less than the treatment cycle;
* patients with other factors that researcher considers unsuitable for inclusion.
Bioequivalence Study of INS062 and Pharmacokinetics and Pharmacokinetics Study of Single Injection of HR20014 in Healthy Subjects

This study was divided into two parts. The aim of this study is to investigate the bioequivalence of INS062 injection andNovoRapid ® in healthy subjects(Part I), and to investigate the pharmacokinetics and pharmacodynamics of single dose of HR20014 injection and BIAsp 30 in healthy subjects(Part II).


Eligibility Criteria:
Inclusion Criteria:

1. Male subjects aged 18 \~ 45 (including the boundary. value)(Part I). Subjects aged 18 \~ 45 (including the boundary value), male or female(Part II).
2. Subjects who are considered to be generally healthy, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
3. Body Mass Index (BMI) between 18.0-26.0 kg/m2 (both inclusive).

Exclusion Criteria:

1. A history of recurrent or severe drug food allergy, or known or suspected allergy to any component of the study drug.
2. Have a history of hypertension.
3. Severe systemic infectious diseases within 1 month before screening.
4. Use of prescription drugs (topical eye/nasal drops and creams and occasional antipyretic and analgesic drugs such as acetaminophen within recommended doses are permitted) and over-the-counter drugs, and Chinese herbal medicine (regular vitamins are allowed) within 2 weeks before screening.
5. Presence of any abnormal and clinically significant laboratory tests.
6. 12-lead electrocardiogram (ECG) showed abnormal and clinically significant.
7. Known or suspected history of drug abuse or positive urine drug screening test within screening period.
8. Those who have participated in any drug clinical trials within 3 months or 5 half-life periods before screening (The elder shall prevail), who participated in clinical trials are defined as random, prior to screening;
9. Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential (WOCBP) are reluctant to use appropriate contraception during the trial.
Effects of Achieving Very Low LDL-Cholesterol After Treatment With Statins on Steroidogenesis and Cognition

We aimed to compare the effect of achieving an LDL-cholesterol \<70 vs an LDL-cholesterol \<100 mg/dL with simvastatin or atorvastatin on adrenal and testicular steroidogenesis, and cognition in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* patients with controlled type 2 diabetes mellitus with overt CVD
* patients with controlled type 2 diabetes mellitus over the age of 40 years without overt CVD,but with one or more major cardiovascular risk factors

Exclusion Criteria:

* uncontrolled hypertension (systolic blood pressure \>180 mm Hg or diastolic blood pressure \>95 mm Hg); evidence of active active liver disease or hepatic dysfunction defined as a level of liver transaminases \>2 times the upper limit of normal; uncontrolled myocardial ischaemia; congestive heart failure (New York Heart Association classification IIIb or IV); hemodynamically important valvular disease; secondary hypercholesterolemia; gastrointestinal disease that might limit drug absorption or partial ileal bypass; myopathy, or rhabdomyolysis; a known hypersensitivity to statins; using any androgenic, estrogenic, progestogenic, antiandrogenic, or antiestrogenic agents or medications that can alter the gonadal steroid milieu; using systemic immunosuppressants or anticoagulants; plasma creatine kinase levels \>50% above the upper limit of normal,transient ischaemic attack or stroke in past,severe hypertriglyceridaemia (fasting triglyceride level ≥350 mg/dl,Currently on psychotropic medications, steroids, opiate analgesics, Known case of major neuropsychiatric illness,Poor cognition at baseline \[Mini-Mental State Examination(MMSE) score ≤24\],Physically or mentally unable to complete tests, history of other risk factors for hearing loss and/or conventional assessment that presented conductive hearing loss, confirmed by acoustic immittance measurement;presence of non-auditory associated disorders that could lead to long-latency potentials, such as neurological diseases or syndromes
Depth of Anesthesia in Cardiac Surgery

The aim of our study was to evaluate the significance of monitoring anesthetic depth for the conduct of anesthesia and the early postoperative period in patients subjected to surgical correction of combined valvular disorders.

Our aim was to evaluate the effect of monitoring anesthetic depth on duration of postoperative mechanical ventilation and ICU stay after surgical correction of combined valvular disorders.

Eligibility Criteria:
Inclusion Criteria:

* requirement of surgical correction of two or more valves

Exclusion Criteria:

* no
Study of the Quality of Lung Resection

In 2009, centres that carried out lung resection for cancer were required to obtain authorization following the first cancer plan. One of the criteria to obtain authorization was the volume of activity: the centre had to carry out at least 30 lung resections per year for cancer. Five years later, it would be useful to know the impact of this new organization of oncology on the quality of care. To answer this question, the PMSI database is an ideal source of an indicator of quality: in-hospital mortality. This observational cohort study will be conducted using the national PMSI database with data covering the period from 1st January 2005 to 31st December 2013. It will be limited to hospitalization for lung resection. The time will be divided into 3 periods: 2005-2007, 2008-2010 and 2011-2013; the period 2008-2010 includes the implementation of authorizations for cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

Any patients who underwent lung resection for bronchial cancer will be included in this study. The PMSI (Programme de Médicalisation des Systèmes d'Information) database will be searched for all patients with:

* A principal diagnosis of ICD10 (international classification of diseases) codes for bronchial cancer
* And CCAM (Classification Commune des Actes médicaux ) procedure codes for lung resection (segmentectomy, lobectomy, pneumonectomy).

Exclusion Criteria:

* none
Risk Factors of Venous Thromboembolism After Incisional Ventral Hernia Repair.

Aim of our study is to find frequency and risk factors for venous thromboembolism development in patients who underwent surgery for incisional ventral hernia. There were 240 patients enrolled in our retrospective observational cohort study. Included patients were operated for incisional hernia in Saveljev University Surgery Clinic from January 2018 to December 2019. Compression duplex ultrasound of lower legs veins was performed in 2-4 days after surgery for all participants. The primary endpoint was the occurrence of the venous thromboembolism event, including pulmonary embolism.


Eligibility Criteria:
Inclusion Criteria:

* operated for incisional hernia in Saveljev University Surgery Clinic No Exclusion Criteria.
A Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation and a Non-comparative Transplanted Patient Group

A prospective, post-authorisation long-term follow-up trial of patients previously treated with imlifidase prior to kidney transplantation, including a non-comparative concurrent reference cohort.

This is a long-term follow-up trial to the post-authorisation efficacy and safety (PAES) trial (trial 20-HMedIdeS-19). The trial will include patients who participated in the PAES trial and were transplanted with a new kidney after treatment with imlifidase (trial drug) or standard of care medication. Imlifidase is a medicine used to prevent the body from rejecting a newly transplanted kidney and is used before transplantation in adults who have antibodies against the donor kidney and are considered 'highly sensitised' based on a positive crossmatch test.

The purpose of this follow-up trial is to fulfil requirements from the European Medicines Agency (EMA) to continue to evaluate efficacy (kidney function) and safety (side effects) over time, for the patients who were transplanted with a new kidney in the PAES trial. The patients will be followed for up to 5 years after transplantation in the PAES trial to collect valuable long-term data.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent obtained before any trial-related procedures
* Willingness and ability to comply with the protocol
* Previously transplanted in the clinical trial 20-HmedIdeS-19 (PAES)

Exclusion Criteria:

* Inability by the judgment of the investigator to participate in the trial for other reasons
Effects of a Therapeutic Education Program on Treatment Adherence Among Patients Prescribed At-home CPAP or At-home NIV

The primary objective of this study is to study the effect of therapeutic education on patient adherence for at-home continuous positive airway pressure (CPAP) or at-home non-invasive ventilation. This first study will use data already present in the Association for Home Assistance and Rehabilitation (APARD) database to compare patients who received therapeutic education with a control group who did not.

The proposed study calendar refers to the beginning and completion of work on the APARD database.

Eligibility Criteria:
Inclusion Criteria:

* Patients that have been equipped by the Association for Home Assistance and Rehabilitation (APARD) with either a continuous positive airway pressure (CPAP) device or a non-invasive ventilation (NIV) device.

Exclusion Criteria:

-
Efficacy of Topiramate for Hospitalized Patients With Alcoholism

This is a 12-Week, randomized controlled study of topiramate in hospitalized patients with alcoholism


Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized due to alcohol-related problem
* DSM-IV-TR alcohol dependence
* for male: history of alcohol drink \>=35/week, female: history of alcohol drink \>=28/week for at least 1 week during four weeks prior to the admission
* AUDIT score at least 8
* mild or no alcohol withdrawal symptom
* BMI \> 18 kg/m2
* not pregnant and no plan for pregnancy
* intention to decrease or stop drinking

Exclusion Criteria:

* severe psychiatric and cognitive disorders
* other substance dependence, except nicotine and caffeine dependence, during 6 months prior to enrollment
* taking antipsychotics, mood stabilizers, anticonvulsants, opioid analgesics, systemic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram
* unstable medical condition
* medical history of narrow angle glaucoma, renal impairment, kidney stones, and seizures
* moderate to high risk of suicide
* under legal process
* plan to receive a formal treatment for alcoholism from other treatment settings
* pregnancy and nursing woman
* abnormal laboratory tests, including blood urea nitrogen, creatinine, electrolytes, and fasting blood sugar
Venous Sinus Thrombosis : Clinical Picture and Outcome

Cerebral venous sinus thrombosis (cvst) is an underdiagnosed neurological condition with variable clinical presentations and variable risk factors CVST is often an underdiagnosed cause of acute or slowly progressive neurological deficit.

With increasing awareness of the entity and easy accessibility to the non-invasive test like CT and MRI scans,CVST cases are now being diagnosed more frequently and it is now thought to occur more commonly than previously assumed.it is also probably true that this condition is more frequent in underdeveloped countries


Eligibility Criteria:
Inclusion Criteria:

1. All patients admitted to the neurology department and ER of an assuit university hospital with the diagnosis of venous sinus thrombosis
2. accepting to participate in the study
3. of both sex above 18 years and below 70 years

Exclusion Criteria:

* 1. any case evident to have neurological deficit due to cause other than venous sinus thrombosis 2. patients refused to participate in this study 3-patients with uncertainty about her imaging study