cyrilzakka/clinical-trials huggingface dataset:
A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment

This study will evaluate the pharmacokinetics (area under the curve \[AUC\], maximum concentration \[Cmax\], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and multiple doses in participants with CHC infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the target sample size is 48 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 to 65 years of age
* CHC infection as shown on enzyme-linked immunosorbent assay (ELISA) and radioimmunoblot assay (RIBA) or quantifiable hepatitis C virus (HCV) ribonucleic acid (RNA) greater than (\>) 2000 copies per milliliter (copies/mL)
* Use of two forms of contraception during study and 6 months after the study in both men and women
* Normal renal function (creatinine clearance \[CrCl\] \>80 milliliters per minute \[mL/min\]), moderate renal impairment (CrCl 30 to 50 mL/min), severe renal impairment (CrCl less than \[\<\] 30 mL/min), or ESRD requiring hemodialysis
* Patients with ESRD must have been undergoing hemodialysis for at least 2 months

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Male partners of women who are pregnant
* Conditions associated with decompensated and/or chronic liver disease
* Human immunodeficiency virus (HIV) infection
* Interferon or ribavirin treatment within the previous 3 months
* Poor hematologic function, including unstable hemoglobin
* Significant comorbidity or severe illness which would make the participant unsuitable for the study
* Acute renal failure
Exploration of GCase Activity to Identify a Subpopulation Eligible for a Therapeutic Trial in Dementia with Lewy Bodies

This research focuses on the activity of an enzymatic protein: glucocerebrosidase, in dementia with lewy bodies (DLB). Indeed, the mutation of the GBA gene responsible for a decrease in the activity of glucocerebrosidase is the most frequent known genetic risk factor in DLB. However, mutations of the GBA gene are known in another pathology, Gaucher disease, in which treatments have been developed.

The objective of this research is to determine if glucocerebrosidase activity is decreased in DLB. This hypothesis could open up a therapeutic perspective, with treatments already used in Gaucher disease.

Population: 118 patients and 118 control subjects Act of research: blood test

Objectifs :

* Comparison of glucocerebrosidase activity between patients and controls
* Search for variants or mutations of the GBA gene and correlation with glucocerebrosidase activity
* Correlation between clinical characteristics (UPDRS motor scale, MMSE cognitive scale) and GCase activity in patients
* Identification of macrophage abnormalities and the impact of treatments targeting the GBA pathway on the deregulation of biomarkers in patient macrophages.

Eligibility Criteria:
Inclusion Criteria for patients :

* Male or female aged ≥ 50 years old
* Presence of an accompanying person
* Dementia with lewy bodies according to the revised criteria of Mc Keith 2017

Inclusion Criteria for controls:

* Male or female aged ≥ 50 years old
* Absence of cognitive impairment and clinical element for a neurodegenerative disease

Exclusion Criteria for patients:

* Other neurodegenerative disease
* Gaucher disease

Exclusion Criteria for controls:

* Neurodegenerative disease
* Cognitive impairment of all causes
Electrical Impedance Tomography for Endotracheal Tube Placement

Endobronchial tube misplacement is serious complication during general anesthesia in pediatric patients. Correct placement of the endotracheal tube (ETT) in the trachea is crucial. Several methods have been suggested for determination of correct ETT placement. However, to date, auscultation of the left and right lung is the standard of care and the only ubiquitary available method with an error rate of up to 12%. Electrical impedance tomography (EIT) is a new non-invasive method for evaluation of left and right lung ventilation. In this study the investigators investigate the potential role of EIT for proper placement of pediatric endotracheal tubes.

Several methods have been suggested for determination of correct ETT placement. These include for example the marker method, the mainstem method or the formula method. However, to date, auscultation of the left and right lung is the standard of care and the only ubiquitary available method with an error rate of up to 12%. Electrical impedance tomography (EIT) is a new non-invasive method for evaluation of left and right lung ventilation. In this study the investigators investigate the potential role of EIT for proper placement of pediatric endotracheal tubes. For this purpose, pediatric patients are routinely intubated for cardiac catheterization using the mainstem method or 3xETT size method. Placement of the ETT is then verified by intraoperative fluoroscopy and lung ventilation is verified by EIT.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent from the parents
* endotracheal intubation with a standard endotracheal tube

Exclusion Criteria:

* refusal of written informed consent
* severe lung diseases
* contraindication for use of electrical impedance tomography
Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome

This study evaluates the safety of defibrotide in subjects with sickle cell disease (SCD)-associated acute chest syndrome (ACS).


Eligibility Criteria:
Inclusion Criteria:

* SCD-associated ACS with the presence of any two or more of the following signs not explained by other etiologies: Fever, Chest pain, Cough, Dyspnea, Tachypnea for age, Pulmonary infiltrate on CXR and/or Chest CT scan, Decreased O2 saturation with or without oxygen supplement;
* Age 2 to 40 years of age;
* Homozygous Hemoglobin S Disease, Hemoglobin SC Disease or Hemoglobin S 0/+ thalassemia;
* Informed consent/assent;
* Consent of patient/parent within ≤72 hours after inpatient admission for SCD-associated ACS.
* Females of childbearing age will have a negative pregnancy test.

Exclusion Criteria:

* Current Grade III or IV hemorrhage;
* Previous hypersensitivity reaction to defibrotide;
* Current systemic anti-coagulant therapy and/or fibrinolytic therapy;
* Consent of patient/parent greater than 72 hours of inpatient admission for SCD-associated ACS;
* No signed informed consent
Vitamin C Supplementation to Pregnant Smokers: Follow-up of 2 Randomized Trials Plus Changes in DNA Methylation

In a randomized clinical trial (RCT) published in JAMA, the investigators have provided evidence that vitamin C supplementation (500 mg daily during pregnancy) ameliorates the effects of maternal smoking during pregnancy on offspring lung function and subsequent incidence of wheeze by 48% through 1 year of age. The investigators are currently completing a second RCT of vitamin C supplementation in pregnant smokers with more robust measures of pulmonary outcomes. The purpose of this ECHO application is to combine these 2 focused, interventional cohorts to allow critical longitudinal follow-up of respiratory outcomes in these children including the study of pulmonary function test (PFT) trajectories and incidence of recurrent wheeze/asthma from infancy through early adolescence in offspring of pregnant smokers randomized to vitamin C versus placebo.

In a randomized clinical trial (RCT) published in JAMA, the investigators have provided evidence that vitamin C supplementation (500 mg daily during pregnancy) ameliorates the effects of maternal smoking during pregnancy on offspring lung function and subsequent incidence of wheeze by 48% through 1 year of age. the investigators are currently completing a second RCT of vitamin C supplementation in pregnant smokers with more robust measures of pulmonary outcomes. The purpose of this ECHO application is to combine these 2 focused, interventional cohorts to allow critical longitudinal follow-up of respiratory outcomes in these children including the study of pulmonary function test (PFT) trajectories and incidence of recurrent wheeze/asthma from infancy through early adolescence in offspring of pregnant smokers randomized to vitamin C versus placebo.

This will allow the investigators to study the duration of the protection vitamin C provides in the face of in-utero smoke, the relationship between PFTs and the development of recurrent wheeze and/or asthma. In addition we have preliminary data suggesting that, in parallel with the effects of vitamin C on the reduction of pulmonary harm, the supplementary vitamin C blocked the majority of significant changes in DNA methylation induced by maternal smoking in placentas, cord blood and offspring cheek cells. Thus this study will also study the association between the prevention of wheeze/asthma associated with maternal smoking during pregnancy and the prevention of epigenetic changes caused by maternal smoking during pregnancy. By linking the clinical outcomes of decreased wheeze/asthma and pulmonary function in offspring of smokers to epigenetic changes, this study has the potential to identify genes linked to the effects of maternal smoking on lung development and the protective effects of vitamin C.

Eligibility Criteria:
Inclusion Criteria:

* Women and their offspring randomized to vitamin C versus placebo during pregnancy in VCSIP1 or VCSIP2 as well as pregnant nonsmokers and their offspring enrolled as the reference group in VCSIP 1 or VCSIP2

Exclusion Criteria:

* Patients specifically withdrawing consent from VCSIP1 or VCSIP2
Constitution of a Standardized Neural Imaging Database in Healthy Subjects

MRI is a powerful imaging tool used for the precise study of brain morphology (morphometric study, tissue study, study of connectivity).

Isotopic examinations by Single Photon Emission Tomography (SPET) and Positron Emission Tomography (PET) are used to explore cerebral perfusion metabolism (99mTc- ECD SPET and 18FDG PET), as well as dopaminergic neurotransmission (123I FP-CIT SPET, DATSCAN®).

These examinations routinely contribute to the clinical diagnosis and surveillance of many neurological pathologies (dementias, Parkinson syndromes, epilepsies, concussions, vascular pathology, brain tumors, etc.).

As a result of the original morphological and functional information they provide, these examinations are being increasingly included in clinical research protocols involving the brain.

The absolute or relative quantification of anomalies observed, however, can be obtained only after comparison to a database of normal subjects.

The creation of these databases is currently limited by their cost and strictly single center nature (physical characteristics of each center's MRI, gamma cameras and PET scanner).

The aim of this multidisciplinary study is to constitute a standardized database of multimode neural imaging (SPET, PET and MRI) to be able to objectively quantify anomalies observed in patients, at the scale of a group or an individual, for the diagnosis and surveillance of neurological diseases.

Participants will be paid €350. 60 healthy subjects between 20 and 80 years of age (30 men and 30 women) will be recruited over 3 years. 4 examinations will be programmed over 2 days (one cerebral MRI, on 18FDG PET, one 99mTc-ECD SPET and one DATSCAN®).

The strictly single center character of this study is explained by the variability of the physical characteristics of the imaging equipment used (MRI, SPET and PET scan) inherent to each center.


Eligibility Criteria:
Inclusion Criteria:

* no neurological or psychiatric history
* no serious disease
* receiving no neurotropic
* no alcoholism
* no drug addiction
* social security cover
* written informed consent

Exclusion Criteria:

* pregnancy
* breast feeding
* contraindication to MRI, SPET or PET exploration
The Effect of PHGG-rich Enteral Nutrition to on the Infection in Liver Transplant Recipients: A Prospective, Double-blind, Randomized Controlled Study

To known the effect of PHGG-rich enteral nutrition to on the infection in liver transplant recipients


Eligibility Criteria:
Inclusion Criteria:

1. liver transplant recipients
2. age from 18 to 80 years old
3. APACHE II score \>12
4. There is an indication for enteral nutrition and it is expected to require oral or tube feeding for more than 7 days
5. there is no intra-abdominal infection or bloodstream infection

Exclusion Criteria:

1. Severe cardiac, kidney and lung dysfunction
2. bowel obstruction, intestinal perforation, intestinal leakage before operation
3. Roux and Y anastomosis during liver transplant
NOAC Portuguese Real World Study

To determine if there is any difference in the effectiveness and safety outcomes of patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban and vitamin K antagonists


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years on the index date.
* At least 1 OAC (apixaban, dabigatran, rivaroxaban, VKAs) dispensed during the identification period.

Exclusion Criteria:

* Specialty of the physician responsible for the OAC prescription in the index date is one of the following: orthopedics, general surgery, vascular surgery or any other surgical specialty;
* Duration of OAC therapy during follow-up inferior to the cut-off defined during the feasibility assessment (except if the patient was admitted to in-hospital care during follow-up);
* The OAC dispensed in the index date was one of the following: dabigatran 75 mg or rivaroxaban 10 mg
* Hospital claims lacking a diagnosis code indicative of AF during the study period;
* Hospital claim indicating a diagnosis or procedure code indicative of pregnancy or childbirth during the study period;
* Hospital claim indicating a diagnosis or procedure code indicative of valvular heart disease, venous thromboembolism, cardiac surgery, pericarditis, hyperthyroidism and thyrotoxicity during the baseline period;
* Hospital claim indicating a diagnosis or procedure code indicative of hip and knee replacement surgery during the 6 weeks prior to the index date. Patients with past use of OAC will be excluded. Therefore, patients meeting any of the following criteria will be excluded:
* Had any OAC (apixaban, dabigatran, edoxaban, rivaroxaban, VKAs) dispensed during the 12-month baseline period;
* Had \>1 OAC dispensed on the index date.
Telerehabilitation Program Based on Yoga Training in Tennis Players

Although there are frequent studies on core strength in tennis players in the literature, studies on exercise applications targeting the development of physical fitness parameters are limited. In this context, it was aimed to investigate the effect of telerehabilitation method and yoga exercise practice on core stabilization and physical fitness.

Core training is mostly used to improve balance, strength, functional alignment and flexibility. Core training can be a good option to improve physical fitness parameters. It has been observed that core stability training improves core function and trunk control, and positively affects functional and trunk flexibility.

It has been shown that the flexibility of people who practice yoga regularly increases, their posture improves, the mobility of the joints increases, the muscles become stronger, the stability of the ligaments increase, the kinetic chain load transfer is more effective, the breath control is formed, and the person feels more free and dynamic. The target areas of poses such as downward facing dog, plank, boat, shoulder pose, bakasana, which are among the yoga poses, are the core region of the body and are movements that develop core muscles with core activation. Many of the yoga poses require body physical fitness parameters to maintain the pose.

In order for individuals to continue their rehabilitation processes in their own environment and to participate in their training, the telerehabilitation system was frequently used, and according to the results of the study, the effectiveness of the practices performed with telerehabilitation was found to be at a high level.

In this study, it was aimed to investigate the effect of telerehabilitation method and yoga exercise practice on core stabilization and physical fitness.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the study
* Have been playing tennis for at least one year
* Healthy individuals without chronic disease
* No acute injury
* Training at least 4 hours a week
* Using computer and internet

Exclusion Criteria:

* Surgery within the last 6 months
* Having a neurological disease
* Having musculoskeletal diseases
* Use of stimulants
* Use of drugs that will affect psychological or balance
* Inability to use a computer
* Not having internet access
Evaluation of Clinical Decisions and Assessment of Those at Risk of Primary Angle Closure by Community Optometrists

Increases in the aging population has resulted in increased demand for glaucoma services. Glaucoma is a disease that if untreated, can lead to blindness. This increase and need for long term treatment with monitoring have resulted in a significant demand in the hospital eye service (HES). Many departments are now facing a considerable backlog of outpatient appointments and it's essential that these appointments are reserved for patients who are at risk of glaucoma blindness.

Primary angle closure (PAC) glaucoma is a type of glaucoma, where the drainage route for the fluid inside the eye (known as the angle) is narrowed or blocked. It has been recently identified that approximately half of patients referred into the HES for a suspect narrow angle for further investigation are healthy and are immediately discharged. The exact reasons for these findings are unknown.

This project will investigate clinical decisions by community optometrists who account for the majority of PAC referrals into the HES, as well as assessing their ability to evaluate those at risk of PAC. This project will also examine whether clinical agreement could be improved by providing an educational package.

A clinical image database of angles will be acquired from glaucoma patients attending Moorfields Eye Hospital. A learning package discussing angle closure referral will also be developed. Community optometrists will be invited to complete a questionnaire on their clinical decision making. This will be followed by the vignette assessment, learning package and re-assessment.

If this educational package and/or any other identifiers are found to improve agreement levels, this could reduce the number of referrals and enable community monitoring of those at low risk of developing PAC glaucoma in their lifetime.


Eligibility Criteria:
Inclusion Criteria:

New patients attending the glaucoma clinic at Moorfields Eye Hospital

Exclusion Criteria:

* They cannot be examined using a table mounted slit lamp due to physical limitations or have gross nystagmus.
* Unable to consent
* If they are unable to communicate in English and there is no available interpreter that meets requirements set out by Moorfields standard operating policies for patients
* Under 18 years old
ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy

Choices Plus, a randomized controlled study, will determine the efficacy of the Project CHOICES intervention plus a referral to an evidence-based smoking cessation program in reducing the risk of alcohol- and tobacco-exposed pregnancies.

This randomized controlled study will examine the effect of the ChoicesPlus intervention compared to Treatment as Usual (TAU) in: reducing alcohol use below established risk levels; increasing consistent use of effective contraception; increasing engagement in smoking cessation treatment and increasing smoking cessation. In addition, our examination of the incremental costs of the ChoicesPlus intervention (e.g., staff time, materials, administrative services, total medical charges pre- and post-intervention) will provide a basis for future cost/benefit analyses that will inform policymakers and healthcare organizations of the potential benefits of implementing ChoicesPlus. Results from this study will inform and advance future efforts in the service of promoting healthy prenatal behavior and reducing the prevalence of alcohol and tobacco-exposed pregnancies.

Eligibility Criteria:
Inclusion Criteria:

* Have no condition causing infertility
* Are not pregnant or planning to become pregnant in the next 9 months
* Have had vaginal intercourse during the previous 3 months with a fertile man without using effective contraception
* Are drinking at risk levels; and 5) are available for the follow-up period.

Exclusion Criteria:

* Infertile
* Pregnant
* Insufficient locator information
* Language other than English or Spanish
e-PAT Neuromod Evaluation of Personalized rTMS for Resistant Depression

Although repetitive trans-cranial magnetic stimulation (rTMS) is an effective therapy for resistant depression, it still fail to remit up to 70% of these patients. We hypothesize that personalizing the procedure using functional MRI to better select dysfunctional regions and robotic coil placement to stimulate these regions homogeneously, will increase its efficacy. Individualized rTMS will be compared to traditional rTMS procedure and to trans-cranial direct current stimulation (tDCS).

In this small proof of principle study our primary outcome measure will be the correction of the MRI anomalies. Symptoms reduction and the proportion of remitters will be secondary outcome measurements.


Eligibility Criteria:
Inclusion criteria:

* Aged from 18 to 65 Y
* Affiliated to the health insurance
* Having signed an informed consent
* Suffering from major depression according to the DSM5
* Unresponsive or incomplete remission after at least one trial of antidepressant (\> 6 weeks at efficient dose or side effects)
* Treatment stable for \> 6 weeks

Exclusion criteria:

* Contraindication for MRI, rTMS or tDCS: non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump clip or vascular stent, heart valve or ventricular shunt, seizure disorders, skin pathology in the region of tDCS electrode placement.
* Pregnancy
* Severe and non-stabilized somatic pathology
* Patients deprived of liberty or hospitalized without their consent
A Second Study of NicVAX/Placebo as an Aid for Smoking Cessation

The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.


Eligibility Criteria:
Inclusion Criteria:

* Current smoker who smokes at least 10 cigarettes a day during the past year and wants to quit smoking.
* Smokers who are in good general health.

Exclusion Criteria:

* Prior exposure to NicVAX or any other nicotine vaccine.
* Use of systemic steroids.
* Cancer or cancer treatment in the last 5 years.
* HIV infection.
* History of drug or alcohol abuse or dependence within 12 months.
* Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.
* Inability to fulfill all visits for approximately 52 weeks.
iPad Application-based Intervention for Post-stroke Depression

We plan to conduct a randomized controlled trial to examine whether usual rehabilitation plus an iPad application-based intervention improves post-stroke depression symptoms compared to usual rehabilitation alone.

The purpose of this pilot randomized controlled trial is to investigate the feasibility of the final randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* 40 years and older
* Males and females
* Center for Epidemiologic Studies Depression Scale score ≥16
* Mini Mental State Examination score ≥ 24
* First stroke
* Native language is Japanese
* Written informed consent prior to participation

Exclusion Criteria:

* Major depressive disorder before onset of stroke
* Bilateral hemiplegia
* Vision or hearing deficits that negatively impact everyday life
* Severe aphasia
* Severe unilateral spatial neglect
* Diagnosis of neurodegenerative disease such as Parkinson's disease or multiple system atrophy
* Current life-threatening severe organ failure, musculoskeletal disorders, or cancer