cyrilzakka/clinical-trials huggingface dataset:
Cognition and Affect After Stroke: a Prospective Evaluation of Risks

Stroke is a leading cause of disability, affecting about 34,000 to 41,000 individuals in the Netherlands of middle and old age every year. Due to the aging of the population, this figure will increase considerably over the next decades (Struijs et al., 2005). Twenty-five percent of stroke patients die within one month, making stroke a major risk factor for premature death in developed countries. According to the World Health Organization, stroke is the third leading cause of the burden of disease in middle and high-income countries (World Health Organization, 2008). It has a significant negative impact on quality of life of both the patients as well as their caregivers and significant others. Surviving stroke patients often struggle with its manifold and lifelong lasting consequences, with 35 percent of patients being functionally dependent one year after stroke (Wolfe, 2000) and cognitive and emotional changes which are found up to two years post-stroke (Rasquin, Lodder, \& Verhey, 2005). Depression, apathy, and cognitive impairment are very prevalent and significantly contribute to the burden of the disease, but their etiologies remain poorly understood.

The aim of the CASPER study is to gain more insight into the etiologies of post-stroke depression (PSD), post-stroke apathy (PSA), vascular cognitive impairment (VCI), and post-stroke dementia. Therefore, the primary objectives are to identify biomarker-based predictors of PSD, PSA, and VCI. A secondary aim is to study effect modulation, especially the interaction between cerebrovascular disease, neurodegenerative changes and inflammation in post-stroke dementia.

CASPER is a prospective clinical cohort study of 250 first-ever ischemic stroke patients with serial assessments at baseline (10 to 12 weeks after stroke), six and 12 months after baseline. Another wave (36 month after baseline) was later added.


Eligibility Criteria:
Inclusion Criteria:

* First-ever or recurrent ischemic or hemorrhagic stroke
* MMSE score ≥15 (to ensure valid testing)
* Written informed consent
* Sufficient knowledge of the Dutch language
* Preferably participation of an informant

Exclusion Criteria:

* Age younger than 40 years (to exclude atypical strokes)
* Pre-stroke dementia (assessed by a semi-structured interview with a relative, based on clinical diagnosis or IQ-CODE) in the five years prior to stroke
* Psychiatric and neurological disease other than the qualifying event known to affect cognition such as schizophrenia, bipolar disorder, substance abuse, Parkinson's disease, or epilepsy
* Current episode of depression at admission (as evidenced by medical records and patient or informant interview). In contrast, a lifetime history of depression will not be considered as a reason for exclusion as this is considered a potential risk factor for PSD
* Severe aphasia (as it interferes with understanding and following test instructions)
Study of the Efficacy of an Investigational Drug in Adult Patients With Non Small-Cell Lung Cancer (NSCLC)

The primary goal of the study is to evaluate an investigational drug's effectiveness as a treatment for Non small-cell lung cancer (NSCLC)


Eligibility Criteria:
Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.

Inclusion Criteria: Eligible patients must be at least 18 years of age with a diagnosis of NSCLC that has gotten worse during or after treatment with platinum-based chemotherapy. Patients must have at least one tumor that can be evaluated by the doctor during the investigational drug treatment. Any side-effects from prior chemotherapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function.

Exclusion Criteria: Any of the following will exclude patients from study participation: receipt of more than 1 prior regimen of chemotherapy for NSCLC (repeat of the same chemotherapy at different points in time count as 1 regimen). Irradiation to 25% or more of bone marrow, prior high dose chemotherapy with bone marrow or stem cell support, current participation in other clinical trials, pregnant or breast-feeding women, known HIV-positive or AIDS-related illness.
Blood Transfusion by Boston MedFlight Registry

The primary aim of this observational registry is to study the outcomes of patients with hemorrhagic shock transported by Boston MedFlight receiving blood products during transport.

Boston MedFlight, a critical care transport organization, based on a consortium of the academic medical centers in Boston, will begin carrying PRBC in 2019. The program is intended to provide BMF clinicians with 24-hour immediate access to appropriate blood products to be utilized if needed for patients following life-threatening illness or injury. The four fundamental goals of this program are: save lives' ensure transfusion safety; minimize blood product waste; and conduct continuous quality assurance. Our goal is to observationally evaluate this new protocol of administering blood products in the pre-hospital setting. We will collect data on patients with hemorrhagic shock being transported by Boston MedFlight, who receive or would have been eligible to receive pre-hospital blood transfusion by the inclusion criteria.

Eligibility Criteria:
Inclusion criteria:

* Adult patients who would be eligible to receive blood products;

  * systolic blood pressure \<90 mmHg
  * a shock index of \> 0.9
  * clinical signs of shock as determined by the transport clinicians.

Exclusion Criteria:

* Age \< 18 years old
Drug-Eluting Balloon in Arteriovenous Graft

The investigators' study aims is to evaluate the safety and efficacy of percutaneous transluminal angioplasty (PTA) with paclitaxel-coated balloon (PCB) at venous anastomotic stenosis of arteriovenous graft (AVG) in patients with hemodialysis


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 90 years
2. Patients under hemodialysis via prosthetic arteriovenous graft in the arm
3. Vascular access was created for more than 30 days and used at least one successful session
4. Clinical failure for hemodialysis due to higher venous pressure or lower arterial flow
5. Angiography proved venous anastomotic stenosis ≥50% (the entire lesion of venous anastomotic stenosis will be extended into AVG no more than 2cm and naive vein no more than 7 cm). There was no other obvious stenosis.
6. Reference diameter of venous anastomosis within 7 mm

Exclusion Criteria:

1. Patient could not write informed consent
2. Being unwilling or unable to return for follow-up visits or reason to believe that adherence to follow-up visits would be irregular
3. Current or scheduled enrollment in other, conflicting studies.
4. Acute thrombosis in the past 3 months
5. Central venous stenosis
6. Concomitant disease (e.g., terminal cancer) or other medical condition likely to result in death within 6 months
7. A blood coagulation disorder
8. Sepsis or infected arteriovenous access graft
9. A contraindication to the use of contrast medium
10. Pregnancy
Study of Non-Small Cell Lung Cancer Patients in the US Receiving Standard-of-Care and Initiating an Approved Therapy With Risk of Pneumonitis/ILD

This is an observational, prospective, multicenter study conducted in the US to gather evidence in the context of lung cancer to complement the development of a digital solution.

Patients initiating treatment for non-small cell lung cancer (NSCLC) will be prospectively followed to characterize risk factors, signs, and symptoms leading to onset, diagnosis, and treatment of pneumonitis/ILD should it occur.

This is an observational, prospective, multicenter study conducted in the US to gather evidence in the context of lung cancer to complement the development of a digital solution.

Data will be collected prospectively from study sites using eCRFs and remotely from patients using a digital health tool.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must be 18 years of age or older, at the time of signing the ICF (Informed consent).
2. Have histologically or cytologically documented unresectable Stage III or Stage IV NSCLC.
3. Are initiating treatment with an FDA (Food and Drug Administration)-approved immune checkpoint inhibitor (alone or in combination with other agents), antibody drug conjugate, or small molecule EGFR inhibitor.
4. Minimum life expectancy of 12 weeks at the time of signing the ICF.
5. Able and willing to provide written signed informed consent.
6. Able and willing to use the digital health tool throughout the duration of the study.

Exclusion Criteria:

1. Concurrent participation in a research study or a clinical trial.
2. Unable to receive SoC for the treatment and management of NSCLC including clinical or imaging assessments for up to 6 months.
3. Judgment by the Investigator that the patient is unsuitable to participate in the study and/or the patient is unlikely to comply with study procedures and requirements.
4. Confirmed or suspected diagnosis of pneumonitis/ILD at the time of signing ICF. This does not apply to historical pneumonitis/ILD events that have resolved prior to signing ICF.
5. More than 2 weeks have passed from the administration of the first dose of qualifying FDA-approved treatment.
Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis

This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis. The study includes adalimumab treatment as an active reference arm.

Patients will be randomized to receive one of three sonelokimab treatment regimes, adalimumab or placebo. Primary efficacy evaluation will take place at Week 12. Patients will be allocated to a further 12 weeks of treatment with sonelokimab or adalimumab based on response assessment at week 12. In certain countries, treatment will end at week 12.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is ≥18 years of age;
2. Participant has a confirmed diagnosis of PsA per the 2006 Classification criteria for Psoriatic Arthritis (CASPAR) with symptoms for ≥6 months prior to the Screening Visit;
3. Participant has active disease (defined by a TJC68 of ≥3 and a SJC66 of ≥3);
4. Participant has either current active PsO or a dermatologist confirmed history of PsO;
5. Participant tests negative for rheumatoid factor (RF) at the Screening Visit;
6. Participant tests negative for anti-cyclic citrullinated peptide (CCP) antibodies at the Screening Visit;
7. Participant must be, in the opinion of the investigator, a suitable candidate for treatment with adalimumab per approved local product information.

Exclusion Criteria:

1. Participant with known hypersensitivity to sonelokimab or any of its excipients;
2. Participant with known hypersensitivity to adalimumab or any of its excipients;
3. Participant who has previously failed on anti-interleukin (IL)-17 therapy;
4. Participant who has previously failed on anti-tumor necrosis factor alpha (TNFα) therapy;
5. Participant who has had previous exposure to more than 2 biologic agents of any type to treat PsA prior to the Screening Visit;
6. Participant who has a diagnosis of chronic inflammatory conditions other than PsO or PsA;
7. Participant who has a diagnosis of arthritis mutilans
Simple Simulation Based Breast Cancer Awareness Training

It was planned to determine the effect of simple simulation-based breast cancer awareness training on women's breast cancer knowledge and fear levels. The research population will consist of female service personnel working in institutions within the University of Health Sciences (SBÜ) (N: 670). In order to determine the sample size in this research, which was planned as a quasi-experimental with a pre- and post-test design and a control group; The data showed a normal distribution, the standard deviation of the population was estimated to be 1, and the effect size (difference) was estimated to be 0.8. It was calculated that if two independent n₁=40, n₂=40 samples were taken for the analysis to be carried out, at a 5% significance level, the maximum power value of the research would be 0.942182. Both groups will be given theoretical training about breast cancer awareness, and women in the intervention group will practice breast cancer awareness with a simple valid simulator. All groups will be informed before the applications. The training content will be supported by distributing a 5-page training booklet created from breast health and cancer awareness content to the participants. "Comprehensive Breast Cancer Knowledge Test", "Breast Cancer Fear Scale" and "Breast Cancer Awareness Scale" will be applied as a pre-test after the information.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research.
* To work as female service personnel in institutions within the University of Health Sciences.

Exclusion Criteria:

- Not participating in all applications of simulation teaching.
Investigating Burnout in Intensive Care in Middle Incoming Turkey

Turkey is a developing country and its intensive care infrastructure is worse than developed countries. The staff is very busy at work. Intensive care has become a new science. We wanted to investigate burnout syndrome among physicians and other health care workers who are starting to work at a new intensive care medicine. Intensive care specialists in Turkey do not work in intensive care centers where they want. This may have a negative effect on physicians.

Burnuot health practices are more common than the normal group. The data about Turkey are limited. In developing societies, there are often no protocols in intensive care. There are no teams again during intensive care. All work is done by physicians and other health workers. This may adversely affect health care workers. Intensive care science is new. The training first started in 2013. The newly graduated heavy-duty specialists can work where they do not want. The workload of the health workers working in the intensive care unit is high. We wanted to investigate burnout on healthcare workers in Turkey.

Eligibility Criteria:
Inclusion Criteria:

fellow, nursing, specialist and academics working intensive care medicine

Exclusion Criteria:
Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions

Severe intraoperative hyperglycemia (SIH) is recognized as one of the important risk factors for the increasing of the postoperative infections rate, which can negatively affect the final outcome of surgical treatment. Studies in recent years have shown a much higher incidence of wound infections, respiratory and urinary tract infections in patients who intraoperatively had an increase in blood glucose level (BGL) above 180 mg/dl (10 mmol/l). This problem in neurosurgery is especially important due to the high proportion of patients with acute injuries and potentially long-term need for postoperative intensive care, as well as the frequent use of drugs that increase blood glucose level (steroids) in neurooncology. Most published studies include patients from both of these groups. This study is aimed to assess the impact of severe intraoperative hyperglycemia on the incidence of infectious complications only in patients scheduled for elective intracranial interventions.


Eligibility Criteria:
Inclusion Criteria:

Adult patients (\>18 years) scheduled for elective intracranial (open or endoscopic) intervention.

Exclusion Criteria:

Diagnosis of infection (local or systemic) in preoperative period; urgent intervention.
Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia

The purpose of this study is to investigate whether early expose to general anaesthesia will influence neurodevelopment.

Participants, according to the state of illness and clinical requirements, assigned to receive dental caries treatment with or without general anesthesia. During the follow-up, various of neurodevelopment assessment will be done at specific timepoint to investigate whether general anaesthesia will influence neurodevelopment.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age\>=36 weeks
* American Society of Anesthesiologists（ASA） physical status Ⅰ or Ⅱ，with very limited systemic disease.
* Age\<=6 yr

Exclusion Criteria:

* did not provide research authorization；
* unable to contact or inconvenient for follow-up;
* hypersensitive to general anesthesia drug;
* previous exposure to general anesthesia in utero;
* previous exposure to general anesthesia as a neonate
* previous exposure to psychotropic medication;
* complications at birth such as low weigh, hypoxia, or cerebral edema;
* any other known diseases may influence the neurodevelopment
Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects

This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.


Eligibility Criteria:
Inclusion criteria:

1. Healthy males.
2. Complete medical history, including physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
3. Aged 21 to 50 years.
4. Body mass index below or equal to 30.
5. Body weight 65 to 95 kg, inclusive.

Exclusion criteria:

1. Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
2. Any evidence of a clinically relevant concomitant disease, as judged by the investigator.
3. History of relevant orthostatic hypotension, fainting spells, or blackouts.
4. Chronic or relevant acute infections.
5. History of relevant allergy/hypersensitivity (including allergy to the study medications or its excipients).
6. Intake of prescribed or over-the-counter drugs within less than 6 half-lives of the respective drug prior to study drug administration or during the trial.
7. Participation in another trial with a study medication within two months prior to administration or during the trial (six half-lives).
8. Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day).
9. Inability to refrain from smoking during days of confinement at the study center.
10. Current alcohol abuse as judged by the investigator.
11. Current drug abuse, as judged by the investigator.
Influenza Resistance Information Study

This study will assist in the early detection of influenza resistant to antivirals and will monitor the clinical outcome of adults and children infected with influenza according to subtype and susceptibility. Participants clinically diagnosed with influenza will undergo a rapid diagnostic test and viral sampling at Baseline and on Days 3, 6, and 10. Participants will be clinically managed according to local guidelines and the decision to treat/not treat will be at the discretion of the Investigator.


Eligibility Criteria:
Inclusion Criteria:

* Participants greater than or equal to (≥) 1 year of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness (during Years 1 to 5)
* Participants less than or equal to (≤) 12 years of age with a positive diagnostic test of influenza and displaying symptoms suggestive of influenza-like illness and who are being or, according to local standard of care, will be treated with an influenza antiviral (during Years 6 and 7)

Exclusion Criteria:

* Allergy to any potential influenza therapy
* Living in the same household or residential/care home as another study participant
Effectiveness of a Person-centred Prescription Model at the End of Life

This study's main objective is to investigate whether the application of an adapted person-centred prescription model during a hospital stay would reduce the use of inappropriate or futile regular medications in older people at the end of life, improving their clinical/health statuses and reducing the expense associated with pharmacological treatment. We hypothesised that applying this modified method could optimise pharmacotherapeutic indicators and the expense associated with the pharmacological treatment of hospitalised patients


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the geriatric convalescence unit and identified as having a non-oncological advanced chronic disease and being in need of palliative care, with a limited survival prognosis according to the necessity of palliative care (NECPAL) test.

Exclusion Criteria:

* Patients with hospital stays of less than 72 hours.
* Patients transferred to other hospitals or units.
* Patients with imminently terminal patients.
Assessment of the Efficacy of a Neoadjuvant Combination: "Chemotherapy-targeted Therapy" in Breast Cancer.

The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination "Taxotere-Erbitux".


Eligibility Criteria:
Inclusion Criteria:

* § Age \> or equal to 18 years.§
* Performance status inferior or equal to 1 (WHO criteria)
* Histologically proven breast cancer, non metastatic, with clinical tumor diameter \> or equal to 2 cm.
* HR negative and HER 2 negative.
* Clinical stage II and IIIa.
* Non prior treated patients either by surgery, radiotherapy, hormonotherapy or chemotherapy.§
* Adequate hematological, renal and hepatic functions : neutrophils \> 2.109 /L, platelets \> 100.109 /L, Hb \> 10 g/dL, normal bilirubin, ASAT and ALAT inferior or equal to 2,5 ULN (upper normal limit), alkaline phosphatases £ 2,5 ULN, creatinine \< 140 µmol/L or creatinine clearance \> 60 mL/min.§
* Written informed consent§
* Affiliation with social security system (or profit being of such a mode) according to terms' of the law of August 9, 2004.

Exclusion Criteria:

* Male patient.
* Pregnant or lactating women or childbearing potential with no efficacy contraception.
* Other breast cancer form and particularly inflammatory form and/or negliged (T4b or T4d).§
* Non measurable tumor.
* Prior surgery or primary axillary dissection.
* Prior treatment for this new breast cancer.
* Under guardianship patient
* Patient with antecedent of second cancer, excepted in situ uterine carcinoma or baso-cellular cutaneous cancer considered as definitively cured.
* Patient with an associated pathology considered incompatible with the study.§ Cardiac, renal, medullar, respiratory or hepatic insufficiency.
* Significant neurological or psychiatric troubles.§ Symptomatic or evolutive troubles in CNS or metastasis.
* Peripheral neuropathy \> grade 2 NCI-CTC (version 3.0)
* Previous allergy with polysorbate 80.
* Concomitant treatment with a drug tested in a clinical trial, participation to another clinical study, for the last thirty days or prior chemotherapy.
* Patients non stable for the following 6 months or leaving at a great distance of the participating center.
Short Term Effects of Increasing Sleep Duration

A series of studies are proposed to develop an intervention to increase sleep duration and study the effects on eating, exercise, and weight control. The hypothesis is that increasing sleep duration will help improve weight loss and maintenance.

Study 1 is conducted in a sleep laboratory. Participants sleep short duration (approximately four hours per night) on one weekend and long duration (approximately nine hours per night) on another weekend.

Study 2 is examining ways to increase sleep duration in overweight individuals with short sleep and examining the effects on short term weight loss.

Study 3 is comparing a standard weight loss program with a novel Sleep+Weight Loss intervention.

Eligibility Criteria:
Inclusion Criteria:

* age 25 to 45;
* BMI 25 to 50;
* healthy;
* sleep 6.5 hours or less per night

Exclusion Criteria:

* use of sleep medications;
* sleep apnea;
* third shift worker