cyrilzakka/clinical-trials huggingface dataset:
Platelet Sub-study of the TWILIGHT Trial

TWILIGHT study is a multicenter RCT comparing treatment with ticagrelor alone versus ticagrelor plus aspirin in high-risk patients after PCI. All patients will receive DAPT (ticagrelor plus aspirin) for the initial 3 months post-PCI and then be randomized to either Ticagrelor alone OR Ticagrelor plus Aspirin DAPT.

To investigate the pharmacodynamic effects of the two treatments in this trial, a 'Platelet Sub-study' will be conducted only at the Mount Sinai Medical Center. The sub-study will recruit randomized patients from the TWILIGHT Trial at Mount Sinai and conduct specialized blood tests at randomization and one month thereafter. The aim of the Platelet Sub-study is to compare the antithrombotic effects of Ticagrelor alone versus Ticagrelor plus Aspirin using an ex vivo model of thrombosis (Badimon Chamber).

The present study will enroll a cohort of randomized patients from the TWILIGHT trial at the Mount Sinai Medical Center. These subjects will undergo blood sampling and measurement of thrombotic indices at the time of randomization and 1-6 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

Patients enrolled in the TWILIGHT trial:

Clinical Inclusion Criteria (must meet at least one):

* Adult patients ≥ 65 years of age
* Troponin (+) acute coronary syndrome
* Female gender
* Established vascular disease defined as previous MI, documented PAD or CAD/PAD revascularization
* Diabetes mellitus treated with medications (oral hypoglycemic, subcutaneous injection of insulin)
* Chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2 or creatinine clearance (CrCl) \< 60 ml/min

Angiographic Inclusion Criteria (must meet at least one):

* Multivessel coronary artery disease
* Target lesion requiring total stent length \>30 mm
* Thrombotic target lesion(s)
* Bifurcation lesions with Medina X,1,1 classification requiring at least 2 stents
* Left main (≥50%) or proximal LAD (≥70%) lesion
* Calcified target lesion(s) requiring atherectomy

Exclusion Criteria:

Patients not eligible to participate in the TWILIGHT trial:

* Under 18 years of age
* Contraindication to aspirin
* Contraindication to ticagrelor
* Planned surgery within 90 days
* Planned coronary revascularization (surgical or percutaneous) within 90 days
* Need for chronic oral anticoagulation
* Prior stroke
* Dialysis-dependent renal failure
* Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a raised risk for bleeding, malignancies with a raised risk for bleeding)
* Emergent or salvage PCI or STEMI presentation.
* Liver cirrhosis
* Life expectancy \< 1 year
* Unable or unwilling to provide informed consent
* Women of child bearing potential (as determined by hospital standard of care)
* Fibrinolytic therapy within 24 hours of index PCI
* Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
* Platelet count \< 100,000 mm3
* Requiring ongoing treatment with aspirin \> 325 mg daily.
Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery

A one time oral dose of ALA is taken before surgery. The medication makes the tumor visible under ultraviolet light which allow the surgeon to see more of the tumor for a more complete removal.

Patients with primary neoplastic brain tumors (Grades II-IV) will participate in this trial. Each patient will have been evaluated and found to have such a tumor by history and recent imaging studies (MRI) and deemed a surgical candidate based on current neurosurgical standards of care.

Eligibility Criteria:
Inclusion Criteria:

* Suspected primary brain tumor
* 18 years of age or more
* Normal marrow and organ function
* Eastern Cooperative Group performance status ≤ 2
* Women of childbearing potential must use adequate birth control
* Ability to understand and willingness to sign a written informed consent form
* Life expectancy not a consideration

Exclusion Criteria:

* Receiving any other investigational agents
* History of allergic reactions to ALA
* Personal or family history of porphyrias
* Liver disease in the past year
* Uncontrolled intercurrent illness
* Pregnant or lactating women
* Inability to undergo MRI with contrast
Cognitive Functioning in Adults With Somatic Diseases and General Population From a Biopsychosocial Perspective

The goal of this observational study is to investigate cognitive functioning profiles in adults with neurologically recognized aphasic syndromes and general population.

The study group consist of minimal 600 adults (over 18 y.o.) who will be examined by qualified diagnosticians. Participants will be evaluated with tasks related to the studied variables: memory, learning and language. Furthermore informations regarding past and present health condition will be collected from participants.

The main questions it aims to answer are:

1. What is the profile of memory and learning among polish adults?
2. Do gender and age moderates patterns of memory and learning functioning among polish adults?
3. What is a specific pattern of language functioning in adults with neurologically recognized aphasic syndromes?
4. Do gender moderates specific patterns of language functioning in adults with neurologically recognized aphasic syndromes?

Researchers will compare the following groups of adults:

1. general population/control group
2. with neurologically recognized aphasic syndromes
3. seniors (over 60 y.o.)


Eligibility Criteria:
Inclusion criteria for general population/control group:

* age from 18 to 60 y.o.

Inclusion criteria for neurologically recognized aphasic syndromes

* age above 18 y.o.
* neurologically recognized aphasic syndromes

Inclusion criteria for seniors:

* age above 60 y.o.

Exclusion criteria for general population/control group:

* age less then 18 y.o.
* neurologically recognized aphasic syndromes

Exclusion criteria for neurologically recognized aphasic syndromes

* age less then 18 y.o.
* no neurologically recognized aphasic syndromes

Exclusion criteria for seniors

* age less then 60 y.o.
* diseases of the nervous system, such as: stroke, craniocerebral trauma, neuroinfections, neurodegenerative diseases
* mental disorders such as depression, psychotic disorders, anxiety disorders, addictions
Cosmetic and Functional Sequelae in Hand Burns.

Although it represents a small percentage of the body surface, the hand is the most exposed part of the body after the face and neck and is one of the area's most frequently involved in burns. It has a social function, but above all, a functionnal one. An optimized reconstruction of this area after the burn allow the patient to recover the best possible function and increase his chances of returning to professional activity and daily life. Advances in burn treatment, such as improved resuscitation management, rapid excision of burns, skin grafting, regular dressings, and improved metabolic support, have reduced the morbidity and mortality of severe burns. However, significant challenges remain.

The hand is the most frequently involved area in burns and is affected in 90% of severe burns. Hand burns requiring releasing incisions are circular, deep burns and represent a significant functional challenge. In the acute setting, current treatment options must prevent complications associated with disruption of the skin's protective function. In the longer term, these treatments should allow the regeneration of fully functional skin. However, some sequelae may persist in the form of sensory deficits, residual pain, retractile scars hindering function in this highly mobile area, or even aesthetic sequelae.

The aim of our study was to perform a descriptive analysis of the aesthetic and functional sequelae related to hand burns that required acute realeasing incisions using objective and subjective tools available in the medical records (demographic, clinical and follow-up data in the context of routine care). This retrospective, non-interventional, data-driven study would provide an overview of the sequelae of hand burns with current therapies.


Eligibility Criteria:
* Inclusion Criteria :

  * Adult patients
  * Acute burn (less than 3 days)
  * Burns of one or both hands or finger burns
  * Skin surface burned less than 40% of the body
  * Chemical, thermal, or electrical burns of the hand.
  * Burn that required a skin graft.
* Exclusion Criteria :

  * Patient refusal
  * Less than 1 month follow-up or death within the first month
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women

The purpose of this study is to evaluate the efficacy of hydrolyzed collagen in osteoarthritis.

The current study is part of a larger project called the CalGo-project. The overall purpose of the study is to use bone meal from salmon to promote skeletal health. Specifically, the potential for hydrolyzed collagen type II derived from salmon bone meal in ameliorating pain, stiffness and function in participants diagnosed with osteoarthritis will be evaluated over a time period of 6 months. Past literature indicates that collagen derivatives may be a potential supportive strategy in people suffering from osteoarthritis. Osteoarthritis is a common but complex joint disease with significant unmet medical needs, as there are currently no disease-modifying drugs available. Osteoarthritis represents a global health burden and the only curative treatment when pain becomes unmanageable, is joint replacement.

The dimensions of pain, stiffness, and function will be evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC 3.1). Plain x-rays with Kellgren-Lawrence grading will be employed to classify the severity of osteoarthritis. 100 potential participants will be screened for eligibility. Participants who meet the eligibility criteria will be randomized in a double-blind manner to receive 10 capsules daily of hydrolyzed collagen type II (a total of 5000 mg), 10 capsules daily of salmon bone meal, or 10 capsules daily of placebo.

Eligibility Criteria:
Inclusion Criteria:

* Characteristic joint pain indicating osteoarthritis (OA) in the hip(s) or knee(s).
* A radiologically and clinically verified diagnosis of mild to moderate OA graded 1-3 on a Kellgren-Lawrence (KL) grading scale in affected hips or knees.
* Age 18-70 years.
* Familiar with the Norwegian language, both in writing and orally.
* Willingness to participate in the study.

Exclusion Criteria:

* A radiologically and clinically verified diagnosis of severe OA graded 4 on a KL grading scale in affected hips or knees.
* Use of drugs (and supplements) known to influence bone and joint metabolism, including Glucocorticoids, \> 500 mg daily intake of elemental calcium in medication or supplement form, \> 800 IU daily intake of vitamin D3, cancer therapy
* Pregnancy or breastfeeding
* Known fish allergy and history of hypersensitivity to any of the components in the interventional product.
* Other reasons which the principal investigator deems it necessary to exclude a potential participant.
Evia/Entovis HF-T Master Study

The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and efficacy of these pacemakers. In particular, the left ventricular (LV) capture control feature is evaluated, which automatically measures the LV pacing threshold and subsequently adjusts the pacing output.


Eligibility Criteria:
Inclusion Criteria:

* Standard indication for CRT therapy
* Legal capacity and ability to consent
* Signed patient informed consent

Exclusion Criteria:

* Contraindication for CRT therapy
* ICD indication
* Age \< 18 years
* Pregnant or breast-feeding woman
* Cardiac surgery planned within the next 6 months
* Life expectancy of less than 6 months
* Participating in another clinical study of an investigational cardiac drug or device
Amyloidosis Typing Using Mass Spectrometry-based Proteomics: a New Accurate Tool for Difficult Typing

The main objective is to establish that a new technique of amyloidosis typing by Proteomics (based on nanoLC-MS/MS mass spectrometry) allows typing in \> 90% of observations in patients whose Amyloidosis is reported to have failed typing (impossible typing, uncertain or inconsistent) with the traditional anatomopathological approach, and this in a cohort of 40 patients identified consecutively in the Department of pathological anatomy and cytology of the University Hospital of Toulouse and included prospectively.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Amyloidosis by Red Congo staining and birefringence in polarized light on tissue sampling
* Immunolabeling Amyloidosis typing

  1. impossible (no frozen sample available)
  2. or inconclusive (doubtful)
  3. or inconsistent with clinical, biological, genetic and iconographic data
* Signature of the informed consent form

Exclusion Criteria:

* Insufficient tissue material to perform the new technique
* Person placed under judicial protection
* Pregnant and breastfeeding women
Effects of Mandala Coloring on Premenstrual Syndrome

This research was planned as a randomized controlled experimental study in order to reduce premenstrual syndrome symptoms of women with premenstrual syndrome.

Occurs in the luteal phase and decreases or declines significantly with the onset of menstruation; physical such as breast tenderness, headache, bloating; Premenstrual syndrome is a health problem with more than 150 psychological and behavioral symptoms such as anger outbursts, irritability, anxiety, mood fluctuations, sleep and eating disorders.

Symptoms experienced during the premenstrual period lead to results such as mood/affective disorder in women, deterioration in daily life activities and social relations, an increase in negative health behaviors, as well as low academic performance in students, decreased participation in classes, getting low grades in exams, and not showing up for exams.Since its etiology is unclear, no specific treatment method can be found, and non-pharmacological therapies such as stress control, lifestyle changes, exercise and complementary therapies such as evening primrose oil, chasteberry and acupuncture are applied in its management.

Psychiatrist Carl Gustav Jung discovered the psychic healing transformations created by mandala painting, one of the art therapy methods, through his own experience and that of his patients.

Various studies have determined that mandala coloring improves physical and psychological symptoms, but no studies have been conducted with PMS.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research
* Fully answering survey and scale forms.
* Ability to read and understand Turkish
* Being between the ages of 18 and 30 years
* Having regular menstruation (between 21 and 35 days)
* Having 45 or more from PMSS

Exclusion Criteria:

* Unwilling to continue working
* Having any problem that prevents communication (such as hearing, speaking, and understanding abilities),
* Having a gynecological disease (abnormal uterine bleeding, uterine fibroids, ovarian cysts, hormonal treatment, etc.)
* Having a chronic or physical illness
* Having a mental illness
* Being under psychiatric treatment (Pharmacotherapy or psychotherapy)
* Taking medication for menopausal symptoms
* Using one of the pharmacological or non-pharmacological methods to reduce premenstrual symptoms (COCs, acupressure, homeopathy, etc.)
Bayesian Estimation of Diagnostic Performance of Diabetic Cardiovascular Autonomic Neuropathy Without a Gold Standard

This study aimed to estimate sensitivities and specificities of diabetic cardiovascular autonomic neuropathy (DCAN) diagnostic tests using the Bayesian approach without a gold standard in another independence dataset.The reference the values for the short-term HRV were calculated in the investigators' previous study (including 371 healthy subjects). This study dataset contained 200 diabetic patients who completed both the short-term HRV test and Ewing's test. Simultaneous inferences about the population prevalence and the performance of each diagnostic test were possible using the Bayesian approach without a gold standard.

The CAN prevalence is rapidly growing in all populations worldwide. No document has been reported diagnostic performance of short-term heart rate variability (HRV) for diabetic cardiovascular autonomic neuropathy (DCAN) in the Chinese population. This study aimed to estimate sensitivities and specificities of DCAN diagnostic tests using the Bayesian approach, in the absence of a gold standard in another independence dataset.The reference the values for the short-term HRV were calculated in the investigators' previous study (including 371 healthy subjects). This study dataset contained 200 subjects who completed both the short-term HRV test and Ewing's test. Simultaneous inferences about the population prevalence and the performance of each diagnostic test were possible using the Bayesian approach without a gold standard.

Eligibility Criteria:
Inclusion Criteria:

* Survey diabetic participants with undiagnosed CAN, aged 30-90 years, were included in this study.

Exclusion Criteria:

* Some subjects were excluded from the study to eliminate potential confounding factors that may have influenced their CA function. Briefly, the exclusion criteria were as follows:

  1. history or findings of arrhythmia, and hyperthyroidism or hypothyroidism;
  2. pregnancy or lactation; and/or
  3. serious hepatic or renal dysfunctions.
PAMNEU - Memory in Neurology

Memory in Neurology project (PAMNEU) aims to map the distribution and severity of cognitive impairment in patients of outpatient neurologic offices across the geographical area of the Czech Republic. 1000 patients in 50 neurologic offices will undergo cognitive tests (ALBA and PICNIR) and psychometric scales (FAQ-CZ and GDS-CZ) to asses their functional state and depressive symptoms.

The trial's primary goal is to assess the distribution of cognitive impairment among diagnostic groups in neurologic care according to the ICD-10. Additionally, the feasibility of ALBA and PICNIR methods to uncover previously undiagnosed cognitive impairments will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Dispensarization of at least six months in an outpatient neurologic office with an ICD-10 diagnosis
* Age\>=50
* Permanent residency in the geographical area of the Czech Republic

Exclusion Criteria:

* Diagnosis of mental retardation (F70-F79) according to ICD-10
* Refusal to sign the informed consent and consent with GDPR
* Uncorrected visual impairment
* Uncorrected auditory impairment
* Impairment of hand movement preventing the patient from filling in the questionnaires.
* Inability to participate in the project
Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the long-term safety of asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.

Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively
* Otherwise in good health
* Premenopausal based on Estrogen and FSH levels
* Agrees to use of double barrier method of contraception
* Adequate endometrial biopsy with no significant histological disorder

Exclusion Criteria:

* Any abnormal lab or procedure result(s) the study-doctor considers important
* Significant gynecological disorder such as confirmed endometrial polyp
* Hemoglobin \< 8.0 g/dL
* History of a blood-clotting disorder
* Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away.
Effect of Virtual Reality Environment Created in Preoperative Area and Hand Massage on Patient Outcomes

The aim of this study is to investigate the effects of video watching with virtual reality glasses and classical hand massage on patient outcomes in patients undergoing elective surgery. In addition, it's examined that if virtual reality glasses and hand massage execution is convenient way of to reduce anxiety in patients before surgery.

The main questions it aims to answer are:

* Is there a significant difference between the study groups in terms of post-application anxiety level?
* Is there a significant difference between the study groups in terms of post-application vital signs, pain and patient satisfaction? Researchers will compare responses to anxiety scales before and after the hand massage and virtual reality videos to see if they reduce anxiety levels.

Participants will:

* In the virtual reality group, they will answer the questions on the surgical anxiety scale, watch the video with VR glasses and answer the questions on the scale again.
* In the massage group, they will answer the questions on the surgical anxiety scale, and after the researcher gives them a hand massage, they will answer the questions on the scale again.

Surgical Anxiety Scale: The scale was developed by Burton et al. in 2018 to assess preoperative anxiety levels. Each item of the 17-item scale is answered between 0 and 5 points. It consists of three sub-dimensions reflecting individuals' health status, recovery process, and anxiety about procedures. Health-related anxiety is calculated by adding the scores given to items 7, 8, 9, 10, 12, and 13; recovery-related anxiety is calculated by adding the scores given to items 2, 14, 16, and 17; and procedure-related anxiety is calculated by adding the scores given to items 1, 3, 4, and 5. The total score of the scale is calculated by adding the scores of all sub-dimensions and the scores of the three items not included in the sub-dimensions. A minimum of 0 and a maximum of 68 points can be obtained from the scale. Although there is no cut-off point for the scale, it can be said that surgical anxiety increases as the total score of the scale increases.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo elective surgery and whose general condition is ASA (American Society of Anesthesiology) classification I, II or III
* Patients who are not sedated
* Patients over the age of 18
* Patients without a psychiatric or behavioral diagnosis
* Patients who do not have a communication barrier due to hearing loss or spoken language

Exclusion Criteria:

* Vertigo and motion sickness
* Carpal tunnel syndrome
* Hand cuts