cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability of PF-06818883 in Healthy Subjects

Safety, Tolerability and Pharmacokinetics of PF-06818883


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects of nonchildbearing potential and/or male subjects
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Any condition possibly affecting the placement of an intravenous drug administration line.
* A confirmed positive urine drug screen
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or 2 chews of tobacco per day
* Treatment with an investigational drug within 30 days (or as determined by the local requirement)
* Screening supine blood pressure \>140 mm Hg (systolic) or \<90 mm Hg (diastolic), following at least 5 minutes of supine rest
* Screening supine 12-lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec.
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
* History of sensitivity to heparin or heparin-induced thrombocytopenia
* History of human immunodeficiency virus (HIV), hepatitis B or C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb) or hepatitis C antibody (HCVAb).
* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product
IRIS-Onyx Cohort in the IRIS-DES Registry

The purpose of this study is to evaluate the relative effectiveness and safety of Onyx stent compared to other (drug eluting stents) DES.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 and more
* Intervention with Onyx Drug Eluting Stent
* Agreed with written informed consent form

Exclusion Criteria:

* Intervention with Onyx drug eluting coronary stent and other drug eluting stent at the same time
* Life expectancy of 1year and under
* Cardiac shock
Tissue Collection Protocol for Gastroesophageal Cancers

This proposed collection of primary tumor cells lines will benefit esophageal cancer research within the University Health Network. This collection of gastro-esophageal tumor samples will be used to grow primary tumor cell lines, which will provide researchers with ready samples of various gastro-esophageal cancers. This will help to address the issue of access to these cell lines due to the limited number of patients with gastro-esophageal tumors, and high rates of contamination.

Samples will be collected during surgery, EGD, or other biopsy. The surgeon will resect a sample for the research coordinator and/or fellow who will collect the sample and take it back to the lab for processing. Samples collected will be in excess of standard samples that are sent for pathology. The surgeon will make sure that excess samples will not affect pathological diagnosis. In addition samples may be purchased from the National Cancer Institute's Cooperative Human Tissue Network.

Eligibility Criteria:
Inclusion Criteria:

* Patients with esophagogastric cancer and/or GERD +/- Barrett's esophagus who will undergo surgery and/or EGD as standard of care.

Exclusion Criteria:

* Patients who are not well enough to undergo surgery or EGD as standard of care.
Neoadjuvant Chemotherapy in Upper Tract Urothelial Carcinoma : a Retrospective Multicentric Study.

Upper tract urothelial carcinoma incidence is about 1 /100000/year. These tumors are mostly diagnosed at an invasive stage and the standard treatment is a total nephroureterectomy.

In this population, indication of perioperative chemotherapy is still discussed. The benefit of platinum-based adjuvant chemotherapy was recently confirmed by the prospective trial POUT for pT2-T4 N0-3 M0 tumors with an improvement in recurrence-free survival of 51% in the chemotherapy arm.

However, in this situation, use of adjuvant Cisplatin-based chemotherapy may be limited by the deterioration of renal function due to renal surgery.

There are currently no recommendations on the place of neoadjuvant chemotherapy (NAC) with controversial results.

Moreover, the impact on renal function of the NAC-NUT treatment sequence has so far been little studied.

The aim of this study is to improve scientific knowledge about neoadjuvant chemotherapy in upper tract urothelial carcinoma eligible to a curative surgery. The investigators will evaluate the benefit of NAC on pathological response, overall survival and progression-free survival in a large multicentric cohort. In addition, the investigators will assess the impact of NAC on renal function at a distance from curative surgery will allow the evaluation of its specific toxicity.


Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years of age
2. Male or female
3. Upper excretory tract tumors
4. Localized or locally advanced stage (N0 to N1)
5. Eligible for curative surgery
6. Have received neoadjuvant or primary chemotherapy
7. Neoadjuvant chemotherapy treatment received between 2010 and 2020.

Exclusion Criteria:

1. Patient's opposition to the research
2. UTUC not eligible for curative surgery
3. Locally advanced UTUC ≥ N2 and/or metastatic.
Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations

The purpose of this study is to determine the rate of progression free survival of patients with inoperable cholangiocarcinoma 6 months after enrollment in the study. The patients are treated with combination chemotherapy supplemented by biological agents panitumumab or bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified adenocarcinoma arisen from gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with the above and simultaneous radiologic findings consistent with cholangiocarcinoma
* Minimum 18 years of age
* Curative treatment currently not an option (operation, stereotactic radiation treatment or similar)
* KRAS analyzed and found wild-type (wt)
* Performance status 0-2
* Evaluable disease according to RECIST, i.e. the disease need not be measurable
* Hematology: ANC ≥1.5x10\^9/l. Thrombocytes ≥ 100x10\^9/l
* Biochemistry: Bilirubinemia ≤ 3 x upper normal level. ALAT ≤ 5 x upper normal level.
* Creatinine ≤ upper normal level. At raised creatinine level the measured or calculated GFR must be at least 50% of the lower normal level
* Fertile women must present a negative pregnancy test and use secure birth control during and 6 months after treatment. Men with fertile partners must also take care of secure birth control.
* Written and orally informed consent

Exclusion Criteria:

* Previous cytostatic treatment of inoperable cholangiocarcinoma
* Adjuvant or neoadjuvant chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to treatment start
* Other concomitant experimental treatment
* Severe medical disease such as considerable heart disease, serious active infection or other disease making the patient unfit for study participation as assessed by investigator
* Other malignant disease within 5 years prior to enrolment except from non-melanotic skin cancer and carcinoma in situ cervicis uteri
* Interstitial pneumonitis or subsequent pulmonary fibrosis
* Pregnant or breastfeeding women
* Large-scale surgical intervention, excision biopsy or significant traumatic lesions within 28 days prior to treatment start or presumption that large-scale surgery will become necessary during study treatment.
* Significant non-healing wound or ulcers
* Active hemorrhage or increased risk of hemorrhage (e.g. tumor invasion in large vessels or known esophagus varices)
* Known hypersensitivity to panitumumab, bevacizumab or any of the auxiliary agents
* Grade IV fistulas
* Uncontrolled hypertension, i.e. symptomatic hypertension or non-medically stabilized hypertension \>160/100
* Haemoptysis \> 2.5 ml within 2 weeks prior to enrolment
* Previous serious and unexpected reactions or know hypersensitivity to two or more of the applied cytostatics
Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients

The primary objective of the study is to determine the prevalence of aspirin resistance in chronic kidney disease patients. The secondary objectives are to determine possible risk factors contributing to aspirin resistance in this population.

A cross-sectional of "aspirin resistance in hemodialysis patients" previously done in our institution showed that 23/66 (34.7%) hemodialysis patients were aspirin resistant. In a recent systematic review, renal impairment was associated with aspirin resistance . This association was seen in only two out of the twenty studies used in this meta-analysis . Both these studies are from the same center with a predominant Asian population. In this study we will try to evaluate the prevalence of aspirin resistance in CKD patient without being limited to a specific ethnicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with known structural kidney disease as evident by history or by urinalysis and CKD stage III or IV determined by MDRD formula and who are taking aspirin.

Exclusion Criteria:

* Younger than 18 years of age.
* Bleeding disorder or myeloproliferative disorders.
* Thrombocytopenia with platelets \< 100.000.
* Malignancy.
* Acute hemorrhagic disease.
* A recent history of receipt of platelet glycoprotein IIb/IIIa blockers.
* Liver disease as evident by abnormal liver function and total bilirubin \> 2mg/dl.
* use of anticoagulation.
Effects of Flywheel Resistance Training on Cognitive Function in Stroke Patients

Forty patients will be assigned to either a training group (12 wk unilateral knee extension flywheel resistance exercise; 4 sets of 7 reps 2 days/week) or a control group. Patients will maintain daily routines and any prescribed rehabilitation program. Established methods to assess muscle and cognitive function will be employed before and after the intervention.

This project will disclose whether an exercise paradigm, known to improve muscle function and increase muscle volume in healthy populations, will induce similar adaptations in chronic stroke patients. More importantly, this study will elucidate if any impairment in cognitive function caused by stroke, can be reversed with this particular resistance exercise regimen.

The information gained from this project will have significant implications and aid in advancing rehabilitation programs and exercise prescriptions for men and women suffering from stroke. The overall objective of this research is to promote independence and hence quality of life in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Mild-moderate hemiparetic gait
* \> 6 months post-stroke
* Able to perform flywheel leg-press exercise

Exclusion Criteria:

* Unstable angina
* Congestive heart failure
* Severe arterial disease
* Major depression
* Dementia
* Chronic pain
* Psychotic alterations
Childhood Resiliency Effects for School-wide Treatment in Belize City

The purpose of the study is to use existing school resources and improve identification, referral and local support for children that exhibit exposure to childhood trauma resulting from environmental violence in Belize City. The Ministry of Education has identified the goals of the project to reduce violent behaviors in primary school children and supporting those children that have been exposed to violence or other malicious behavior that would inhibit normal school functioning. In addition, the MOE is supporting additional resources and data collection for a comprehensive evaluation of student behavior and academic performance.

Belize is a country with a developing economy based primarily on agriculture and tourism. Crime and violence are emerging as a threat to the country's governance and business climate. The number of homicides in Belize have increased by more than 30% from 2003-2006. This notion of violence, in particular gang violence, is extremely concerning because the population of Belize is very young. Almost half of the population of Belize is under the age of 18. The youth of Belize are becoming engaged in criminal and delinquent behaviors at an early age that have both individual and societal consequences.

In addition to the violence rates among youth in Belize there is also an educational crisis that must be addressed. Education in Belize is compulsory between the ages of 5-14 and in 2001 93% of 5-14 year old children attended school. Although primary school is mandatory (up to age 14), only about 75% of youth complete primary school and only 25% graduate from secondary school. With few students completing high school it is likely that many may turn to gang related and other illegal activities if they are not prepared to undertake better job opportunities, have not been provided with environmental assets that protect from involvement in risky behavior, and if they are exposed to community/family values that condone gang activity. A number of studies have demonstrated that school-based interventions have moderate effects in reducing violence (average of d = .20 across studies). Combining a sound school-based intervention in Belize that is primarily targeted toward students and teachers, but combined with school-based community/family components designed to heighten awareness of the necessity of protective assets, implemented with local and international support teams, and that fosters positive norms may enhance the effects.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in primary schools under the authority of the Belize Ministry of Education in the Belize District
* Enrolled in eight grades referred to as Infant 1 and 2 (generally aged 5 and 6 years), and 1st through 6th Standard (comprising ages 7 - 12 years)

Exclusion Criteria:

* None
A Trial Assessing Changes in Blood Sugar and the Number of Periods Where Supplementation of Carbohydrate is Needed to Treat Low Blood Sugar, During Two Different Treatment Regimens of NN1250 in Type 1 Diabetics

This trial is conducted in Europe. The aim is to compare changes in blood sugar and the number of periods where carbohydrate supplementation is needed to treat low blood sugar, during two different treatments with NN1250 (insulin degludec), a soluble insulin basal analogue (SIBA) in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus for at least 12 months
* Glycosylated haemoglobin (HbA1c) between 7.5 and 9% (both inclusive)

Exclusion Criteria:

* Donation or loss of more than 500 ml blood or plasma within three months prior to this trial
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) or not able or willing to refrain from smoking and the use of nicotine gum or transdermal nicotine patches during the in-house periods
* Prior or current treatment with metformin or thiazolidinediones
US National TOP Registry

The objective of this Registry is to collect short and long-term post-transplant clinical outcome data of all donor lungs preserved and assessed on the OCS Lung System and to document the performance of the OCS device in the real-world setting after FDA approval in the US.


Eligibility Criteria:
All lung transplant recipients
Meaning-Centered Psychotherapy in Advanced Cancer

We have developed an 8-week Meaning-Centered Group Psychotherapy designed to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose despite the limitations of their cancer illness. This project's overall aim is to explore the feasibility and efficacy of this new and unique psychotherapy intervention for advanced cancer patients in enhancing psychological and spiritual well-being and quality of life by comparing it with a standard supportive group psychotherapy.

As per Brief Summary

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older;
* English speaking;
* Stage III or IV solid-tumor or Non-Hodgkin's Lymphoma;
* Receiving ambulatory care at Memorial Sloan-Kettering Cancer Center in New York City;

Exclusion Criteria:

* Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a group-format intervention;
* Presence of cognitive impairment disorder, such as delirium or dementia that is sufficient, in the investigator's opinion, to preclude meaningful participation and/or informed consent;
* Karnofsky Performance Rating Scale below 50 or physical limitations or illness severity sufficient to preclude participation in outpatient group psychotherapy.
Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug ACU-4429 in subjects with geographic atrophy.


Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of geographic atrophy, as defined in the protocol

Exclusion Criteria:

* Currently receiving or has received a medication prohibited by the protocol
Perceptions and Representations of Vaccination Against COVID-19

SARS COV2, the virus that causes COVID-19, was first described in Wuhan, China. For this pathology, which causes severe respiratory infections, preventing the transmission of the virus has become fundamental, that is why vaccines have been developed. In France, this vaccination campaign took place in a context where the lack of confidence in vaccination is high:

According to a November 2020 IFOP poll, only 41% of French respondents were willing to be vaccinated against COVID-19.

To our knowledge, there are still few qualitative studies on vaccination on the current issue of vaccination against COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Patient with a scheduled appointment in consultation or at the vaccination centre
* Not opposed to participation in the protocol

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient unable to give free and informed consent
* Patient under court protection
* Patient without the cognitive capacity to ensure an interview
End of Life Care in Neonatal Intensive Unite

In China, neonatal death on 2019 was 3.5 per 1000 live births, which counts around 57,000 deaths. In mainland China, parents are mostly the main decision-makers in withdrawing life-sustaining treatments in infants and neonatologists often follow the wishes of the parents. However, there is limited experience in supporting parents after the decision is made to withdraw treatment. The aim of this study was to develop and test a family supportive end-of-life care intervention to decrease parental depression and increase parent satisfaction. Investigators indicated that providing a comfortable environment and supportive care to parents during the final days of life of an infant decrease their depression and increases parent satisfaction. The NICUs in mainland China and beyond might consider involving parents in end-of-life care by providing a single room, have a dedicated psychologist available and provide supportive commemoration materials.

Neonatal death often occurs in tertiary Neonatal Intensive Care Units (NICUs). In China, end-of-life-care (EOLC) does not always involve parents. The aim of this study is to evaluate a parent support intervention to integrate parents at the end of life of their infant in the NICU.

A quasi-experimental study using a non-randomized clinical trial design was conducted between May 2020 and September 2021. Participants were infants in an EOLC pathway in the NICU and their parents. Parents were allocated into a family supportive EOLC intervention group or a standard EOLC group based on their wishes. Primary outcomes were depression (Edinburgh Postnatal Depression Scale for mothers; Hamilton Depression rating scale for fathers) and satisfaction. Student t-test for continuous variables and the Chi-square test categorical variables were used in the statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Infants whose treatment was withdrawn at Corrected Gestational Age (CGA) less than 28 days and their parents.

Exclusion Criteria:

* Infants with an expected time of death less than three hours after NICU admission. Parents were excluded if they had mental health or language issues that might limit their integration and communication with the healthcare team.
TeleNEURO-Rehabilitation Systems for Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial

The goal of the FIT4TeleNEURO pragmatic trial is to verify, in real-life care contexts, the superiority in terms of the effectiveness of early rehabilitation intervention with Telerehabilitation (TR) protocols (TR single Approach, task-oriented - TRsA; TR combined approach, task-oriented and impairment-oriented - TRcA) compared to conventional management (Educational treatment, ET).

The main questions it aims to answer are:

* Are Telerehabilitation protocols more effective than educational treatment?
* Is the TRcA treatment more effective than the TRsA? The study investigates the effects of rehabilitation treatment by comparing the two target cases (Multiple Sclerosis - MS and Parkinson's Diseases - PD).

Participants will be subjective to:

* 3 time-point of assessment (baseline, post-treatment and follow up) with motor, cognitive and quality-of-life measures
* A 5-weeks rehabilitation treatment (4 times/week)


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of probable PD according to MDS criteria (Postuma et al., 2015) in staging between 1 and 3 on the Hoehn \& Yahr scale (Goetz et al., 2004) or diagnosis of MS according to the criteria of MC Donald 2010 (Polman et al., 2011) with disability level at the Expanded Disability Status Scale EDSS (Kurtzke, 1983) ≤ 4.5;
* age between 25 and 85 years;
* preserved cognitive level at the Montreal Cognitive Assessment test (MoCA test \>15.5) (Santangelo et al., 2015);
* no rehabilitation program in place at the time of enrolment;
* stable drug treatment (last three month) with L-Dopa or dopamine agonists (PD group) or Disease Modifying Therapies (DMTs) (MS group).

Exclusion Criteria:

* presence of comorbidities that might prevent patients from undertaking a safe home program or determining clinical instability (i.e., severe orthopedic or severe cognitive deficits);
* presence of major psychiatric complications or personality disorders;
* presence of severe impairment of visual and/or acoustic perception;
* falls resulting in injuries or more than 2 falls in the 6 months prior to recruitment (PD and MS groups).
* pregnancy
* relapse ongoing/at least 3 months since the last relapse (MS group);
* presence of "frequent" freezing as recorded at the administration of Section II (daily life activity) of the UPDRS (score ≥ 3) (PD group);
* EDSS-FS (cerebellar function) ≥ 3 (MS group).