cyrilzakka/clinical-trials huggingface dataset:
Platelet-dependent Thrombosis: a Placebo-controlled Trial of Antiplatelet Therapy (Clopidogrel)

Patients with diabetes are more likely to develop furring of their coronary arteries and present with angina and heart attacks. Furthermore, after such an event, they have poorer outcomes (higher rates of death) and survivors are more likely to have recurring symptoms. Using a novel "clotting chamber" the investigators have shown that patients with diabetes are more likely to develop blood clots. This study will look at the role of different blood thinning medications in patients with diabetes. If successful, the investigators will provide evidence to conduct large clinical studies to look at the role of additional blood thinning medication in reducing heart attacks and strokes in patients with diabetes.

The objective of this study is to compare the effect of Clopidogrel on platelet dependent thrombosis in patients with T2DM and CAD with placebo. The Badimon chamber, an ex vivo arterial injury model is used for this purpose. This model simulates the in vivo situation of high shear arterial wall damage and helps to quantify thrombus which is the sum endpoint of all haemostatic abnormalities seen in vitro.

Eligibility Criteria:
Inclusion Criteria:

* Patients with T2DM and CAS as defined below:

  * Clinical definitions
  * T2DM: Diagnosed according to the WHO criteria \[53\].
  * CAD:Presence of any one of the following: Angina plus positive exercise tolerance test, enzyme and/or Q wave positive myocardial infarction, angiographic evidence ( \>50% stenosis of one vessel), percutaneous or surgical coronary revascularisation.
* Aged between 18 and 75
* Provided written consent for participation in the trial prior to any study-specific procedures or requirements.

Exclusion Criteria:

* Contraindication to Clopidogrel
* Smoking (current smokers and patients who quit smoking less than six months)
* Malignancy(diagnosed or under investigation)
* Haematological disorders (Anaemia, malignancy, bleeding disorders)
* Women of child-bearing potential
* Use of corticosteroids/other antithrombotic agents(warfarin)
* Chronic liver disease (Cirrhosis, malignancy and patients with more than twice the upper limit of liver function tests)
* Unable to consent.
* Use of other investigational study drugs within 1 year prior to study entry
* Previous participation in this study
Discovering Laryngomalacia

Laryngomalacia is the most common congenital malformation of the larynx. It results from abnormal prolapse of supraglottic structures during inspiration. Symptoms usually appear within the first 2 weeks of life. Its severity increases in up to 6 months. 15-60% of infants with laryngeomalacia have synchronous airway anomalies.

500 full term babies ≥37 weeks of both sexes delivered by different modes of delivery, with birth weights ≥2.5 kg, no history of natal or post-natal complications and from the same community. Mothers of these babies are from different socioeconomic standards and from the same community. These babies were diagnosed as having laryngomalacia. Clinical, flexible nasal and laryngeal scope, radiological and milk scintiscan were the tools used in our assessment. One thousand full term babies delivered with normal larynx, almost within the same period of time and from the same community were used as a control.

Laryngomalacia was recognized with significant statistical difference in dacryostenosis, deviated nasal septum, adenoid hypertrophy and gastroesophageal reflux disease. No significant statistical difference in pectus excavatum, cleft lip or palate, congenital lobar emphysema fistula and choanal atresia.

Eligibility Criteria:
Inclusion Criteria:

* 500 full term babies ≥ 37 weeks of both sexes were delivered by different modes of delivery, with birth weights of ≥ 2.5 kg, with no history of natal complications and from the same community.
* Mothers of these babies are from different socioeconomic standards with different educational levels.

Exclusion Criteria:

-
Ecchymosis and Coldness in Patients With Varicose Vein

In this prospective, observational study, the investigators aim to investigate the symptoms of varicose vein patients.

Chronic venous disease is very common in all over the world and affects both the mortality and morbidity depending on the effected vascular territory. It is often overlooked by healthcare professionals due to the underestimation of the prevalence and impact of the disease. It represents a spectrum of conditions varying from simple telangiectasia or reticular veins to skin fibrosis and venous ulceration. The main clinical characteristics are dilated veins, edema, leg pain, and cutaneous alterations in the legs. Varicose veins are dilating superficial veins, which become more tortuous and enlarged, continuously.

Chronic venous disease affects the life quality of patients suffering from the disease, which can be measured with quality-of-life reports. Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms (VEINES-QoL/Sym) questionnaire is a patient based, designed for self-completion instrument to measure both the symptom severity and quality of life. VEINES-QOL measures life quality and VEINES-Sym provides an overall estimate of CVD symptom frequency. From the practitioners daily knowledge of patients with varicose veins, there is a significant proportion of varicose vein patients also suffering from symptoms such as coldness and ecchymosis. In this context, the investigators aim to investigate the symptoms of participants with varicose vein using the VEINES-Sym questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* acceptance of inclusion
* aged between 18-75 years

Exclusion Criteria:

* \< 18 year old
* \> 75 year old
* malignancy
* active infection
* hematological disease (severe anemia, leukemia, polistemia vera, sickle cell disease)
* collagen tissue disease
* severe decompensated heart failure (ejection fraction \< 40%)
* cor pulmonale
* rheumatoid arthritis
* degenerative arthritis
* history of lower extremity orthopedic surgery
* lombar disk hernia
* history of coronary artery by-pass surgery
* severe psychiatric and neurological disease (parkinson disease, schizophrenia, bipolar disease, alzheimer disease, etc.)
* peripheral arterial disease ( history of interventional procedure, claudication, active ischemic complaints)
Clinical Study of Active Intervention in High-risk HFpEF Patients

Based on inclusion and exclusion criteria, this experiment plans to include 924 Heart Failure with Preserved Ejection Fraction(HFpEF) patients with increased risk of all-cause death. The enrolled patients will divided into usual care group (n=462) and targeted intervention group (n=462) in a 1:1 ratio. The usual care patients will receive routine heart failure treatment. Patients in targeted intervention group, on top of routine therapy for heart failure, will receive further therapy targeting therapy to correct hypoalbuminemia, anemia or hyponatremia, and try to enhance medication to lower N-terminal pro brain natriuretic peptide (NT-proBNP), C-reactive protein(CRP), New York Heart Association(NYHA )Classification, to add diuretics for patients with higher right ventricular diameters(RADs),multidiscipline intervention for patients complicating chronic obstructive pulmonary disease(COPD), and actively reperfusion for ischemic HFpEF patients. The incidence of all-cause death will be compared after 3 years follow-up.The primary endpoint is the occurrence of all-cause mortality events during the follow-up period.

Our newly finished study developed and validated a risk prediction model for all-cause mortality in patients with HFpEF based on real-world data. The nomogram prediction model included factors such as NT-proBNP, albumin, age, NYHA class III-IV, CRP, RADs, hemoglobin, COPD, hyponatremia, and Percutaneous Coronary Intervention(PCI). Discharged HFpEF patients with scores ≥200.37 were found to be associated with increased risk of all-cause death up to 3 years. In this trial, we sought to evaluate the impact of targeted risk factors intervention post-discharge in patients with with scores ≥200.37 on all-cause death up to 3 years.

Based on inclusion and exclusion criteria,We will enroll 924 patients with HFpEF and scores ≥200.37. The enrolled patients will divided into a usual care group (n=462) and targeted intervention group (n=462) in a 1:1 ratio. The usual care group patients will receive routine heart failure treatment, Patients in targeted intervention group, on top of routine therapy for heart failure, will receive further therapy targeting therapy to correct hypoalbuminemia, anemia or hyponatremia, and try to enhance medication to lower NT-proBNP, CRP, NYHA Classification, to add diuretics for patients with higher RADs, multidiscipline intervention for patients complicating COPD, and actively reperfusion for ischemic HFpEF patients. The primary endpoint is the occurrence of all-cause mortality events during the 3 years follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Discharged HFpEF patients with risk score \> or equal 200.37.

Exclusion Criteria:

* Patients with a life expectancy of less than 1-year due to malignancy.
Off Clamp Randomization

The purpose of this research study is to compare the effects on kidney function after performing the removal of a kidney tumor with or without clamping the blood vessels during surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 and older.
* Patients willing and able to sign consent.
* Patients with an organ confined renal mass planning to undergo a robotic assisted partial nephrectomy (RAPN).
* Patient with Karnofsky Performance Status (KPS) equal to or greater than 40.

Exclusion Criteria:

* Patients under 18.
* Patients with Karnofsky Performance Status (KPS) less than 40.
* Patients with non-organ confined renal masses (invading renal vein, inferior vena cava, peri-renal tissue, ipsilateral adrenal gland, or metastasis).
* Patients with bilateral synchronous renal masses.
* Patients who can not discontinue Plavix, Coumadin or other anti-platelet or anti-coagulant medications.
* Patients with renal lesions determined to be too complex to perform a RAPN without clamp by the surgeon. (The renal mass may be deemed too difficult based on pre-operatively radiological findings. The surgeon's decision to exclude a mass from a robotic assisted partial nephrectomy would be based on a higher risk of positive margin or complication if a RAPN was performed.)
A Study of JNJ-42847922 (Seltorexant) in Healthy Participants

The purpose of this study is to determine the absolute bioavailability of seltorexant in healthy participants following a single oral dose of seltorexant and an intravenous (IV) infusion dose of 14C-seltorexant.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of medical history at screening and physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at admission to the study site on Day 1
* Healthy on the basis of clinical laboratory tests performed at screening and at admission to the study site on Day -1
* All female participants (regardless of childbearing potential), must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1
* A woman must be a) Not of childbearing potential; b) Of childbearing potential and practicing a highly effective method of contraception (failure rate of less than (\<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until 3 months after the study treatment administration
* Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study site (Day -1) as determined by the investigator. Alanine transaminase (ALT)/aspartate transaminase (AST) concentrations within normal range at screening. One retest for ALT/AST is permitted
* Clinically significant abnormal physical examination, vital signs, or 12-lead (ECG) at screening or at admission to the study site on Day -1 as determined by the investigator
* Participant has a current or recent history of serious suicidal ideation within the past 6 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) for ideation on the Columbia-Suicide Severity Rating Scale (C SSRS), or a lifetime history of suicidal behavior or suicidal attempt as validated by the C SSRS at screening
* Positive test for human immunodeficiency virus (HIV)-1 and HIV-2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies
* Has any history or current diagnosis of obstructive sleep apnea or parasomnias. Participants with restless leg syndrome/periodic leg movement disorder or insomnia disorder are allowed if not requiring medication
Map Healthcare Provision Outside the NHS

* To collect data to show which sites outside of the NHS are currently being signposted to patients by Healthcare Multidisciplinary Professionals
* To collect data about these sites, from patients who have been referred or signposted to sites outside of the NHS from a Healthcare Multidisciplinary Professional
* To develop a database of potential healthcare sites outside the NHS that could become involved in NIHR Healthcare

This is a small-scale pilot project to test out the research design and methodology. This pilot project will take a small-scale approach to mapping non-NHS providers that are currently (a) being recommended and signposted by healthcare professionals and (b) have been experienced by patients. A sample of around 100 participants who are (a) currently employed in a range of healthcare provision settings or who (b) have experienced healthcare provision outside the NHS and who (i) have regular access to internet access in order to access a blog; and (ii) have sufficient English language skills to read and understand questions posted on the blog, will be recruited.

Participants will be asked to provide information via a blog about which non-NHS healthcare provision they would signpost or recommend. There will be opportunities both to record data and to communicate and form discussions with other participants on the blog. This data will be coded and collated onto a database and analysed thematically.

Eligibility Criteria:
Inclusion Criteria:

* currently employed in a healthcare setting in a role that involves direct contact with patients for at least one day per week or
* have been a patient accessing non-NHS healthcare provision within the last two years.
* must have self-reported, sufficient English language ability to read the blog
* have regular personal access to the internet.

Exclusion criteria:

* not currently employed in a healthcare setting in a role that involves direct contact with patients for at least one day per week or
* not have been a patient accessing non-NHS healthcare provision within the last two years.
* not have self-reported, sufficient English language ability to read the blog
* not have regular personal access to the internet.
Patients With Vulvovaginal Candidiasis

The present study aims to evaluate the safety of two mucoadhesive gels containing a propolis standardized extract identified as EPP-AF, with 1 and 2% of propolis. The efficacy studies with both propolis gels will be performed in comparison with clotrimazole cream in patients presenting vulvovaginal candidiasis.

Vaginal candidiasis is the second infection of the genital tract after bacterial vaginosis. Up to 75% of women will have at least one episode in their lives, but the clinical manifestations can be very variable. Around 10 to 20% will be asymptomatic and 5 to 10% will have the recurrent candidiasis that means 4 or more episodes in a year. The predominant symptoms are pruritus in 89% and burning during urination and sexual intercourse in 66%. The therapeutic regimen for acute fungal infections by C. albicans should consider the intensity of the clinical symptoms, recurrence, patient preference for the route of administration and consequent adherence to treatment, presence of pregnancy and the possibility of side effects. In general, the schemes include anti-fungal substances of the azoles type. Intravaginal administration of drugs requires the development of formulations suited to the area and adherence to the treatment can be increased if mucoadhesive formulations are obtained which avoid discomfort and provide adequate release of the active compounds. In this sense, the present project had the objective of developing a mucoadhesive gel containing Propolis Standardized (EPP-AF®) for the treatment of vaginal candidiasis, especially since preclinical efficacy and safety data demonstrated the clinical potential of the product. So the present proposal aims at the clinical study evaluate the efficacy of two formulations with 1 and 2% of propolis in comparison with clotrimazole cream treatment (patients affected by Candidiasis) and also evaluate the safety of both propolis gels in healthy volunteers. The efficacy protocol of the test product in patients with vaginal candidiasis will be performed in an open-label, randomized, three-arm, clinical trial with active clotrimazole-based control. Patients will be recruited (T0) and evaluated at 10 and 30 days after initiation of treatment, and the primary outcome will be the clinical cure rate.

Eligibility Criteria:
Inclusion Criteria:

-Have performed the clinical and laboratory diagnosis of vulvovaginitis by Candida

Exclusion Criteria:

* cPatients with recurrent candidiasis;
* History of hepatic, renal, hematological, cardiovascular diseases and with decompensated diabetes mellitus (glycemia above 200) and obesity with BMI above 35);
* Diagnosis of vulvovaginitis by another agent;
* Make use of chronic antimicrobials (informed by the patient)
* Be pregnant
* Allergy to some component of medications given
Developing Affective HeaLth to Improve Adherence to Health Behaviors in Diabetes (DAHLIA II)

Participants will be randomly assigned to either a positive affect skills intervention or a psychoeducation control group and assessed with questionnaires before, during, and after the 8-week program, as well as at 3 months, 6 months, and 12 months after the end of the program.

Participants will be randomly assigned to either the Diabetes positive affect skills intervention or a psychoeducation control group. Both programs last 8 weeks and take place on a simplified research version of the Happify platform. Participants assigned to the diabetes positive affect program will have full access to Happify, with a track that focuses on building skills for greater happiness, reducing stress, and coping better with diabetes displayed as the feature track. Participants assigned to the psychoeducation (control) condition will be asked to complete a series of polls on various wellbeing topics, and then provided with some social comparison data about how their responses compared with the responses of other users, as well as information about why the well being topic is important. Participants will be asked to complete questionnaires before, during, and after the 8-week program as well as 3 months, 6 months and 12 months follow-up questionnaires after the program is complete, at which point study participation will end.

Eligibility Criteria:
Inclusion Criteria:

* Adults with Type 2 Diabetes
* Elevated HbA1c levels (7 or greater)
* No prior experience on the Happify platform (new user registration)
* PHQ-8 score of 13 or higher
* US resident
* Under the care of a medical professional for the treatment of their diabetes
* Be willing and able to obtain HbA1c every 3 months

Exclusion Criteria:

* none
Artificial Intelligence Prediction Tool in Thymic Epithelial Tumors

Thymic epithelial tumors are rare neoplasms in the anterior mediastinum. The cornerstone of the treatment is surgical resection. Administration of postoperative radiotherapy is usually indicated in patients with more extensive local disease, incomplete resection and/or more aggressive subtypes, defined by the WHO histopathological classification.

In this classification thymoma types A, AB, B1, B2, B3, and thymic carcinoma are distinguished. Studies have shown large discordances between pathologists in subtyping these tumors. Moreover, the WHO classification alone does not accurately predict the risk of recurrence, as within subtypes patients have divergent prognoses.

The investigators will develop AI models using digital pathology and relevant clinical variables to improve the accuracy of histopathological classification of thymic epithelial tumors, and to better predict the risk of recurrence.

In this multicentric and international project three existing databases will be used from Rotterdam, Maastricht and Lyon. For all models one database will be used to build AI models, and the other two for external validation.

The ultimate goal of this project is to develop AI models that support the pathologist in correctly subtyping thymic epithelial tumors, in order to prevent patients from under- or overtreatment with adjuvant radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

Participants with specific diagnoses are eligible for inclusion in the study. The eligible diagnoses include various subtypes of thymoma and thymic carcinoma, specifically:

* Thymoma A
* Thymoma AB
* Thymoma B1
* Thymoma B2
* Thymoma B3
* Thymic Carcinoma

Inclusion is based on a consensus diagnosis with a level of agreement less than 70%. This criterion is applied during the training phase of the model.

Recurrence Criteria:

Participants with a documented recurrence outcome within a 5-year period are considered eligible for this aspect of the study. This criterion is primarily applied during the validation phase.
Comparison of Three-chamber-bag Versus Compounded Bag

The purpose of the study is to investigate the efficacy and safety of a convenient 3-chamber-bag containing aminoacids, glucose and lipid emulsion (LCT/MCT 20%) compared to a conventionally compounded monobag for parenteral nutrition.


Eligibility Criteria:
Inclusion: •Patients considered for elective open abdominal surgery

* Male and female patients ≥18 and \<85 years of age
* Indication for total parenteral nutrition therapy: for 6 consecutive days
* NRS ≥3
* Ability and willingness to give voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Review Board (IRB) prior to all evaluations, and to comply with the requirements of the study

Exclusion: Major criteria:

* Body weight \< 50 kg or \> 70 kg
* Laparoscopic surgery
* Seriously ill patients in need of high energy nutrition support (i. e. \> 2100 Kcal/day)
* Hepatic surgery
* Surgery with estimated blood loss \>1000ml
* Participation in a clinical study with an investigational drug or an investigational medical device within one month prior to the start of study
* Receiving regular parenteral nutrition within 7 days before the onset of study
* General contraindications for parenteral nutrition (acidosis of various geneses, untreated disorders of electrolyte and fluid balance, hyperhydration, acute pulmonary edema, inadequate cellular oxygen supply)
* General contraindications for infusion therapy such as acute pulmonary oedema, hyperhydration and decompensated cardiac insufficiency, acute stroke
* Known hypersensitivity to egg-, soy-, and peanut proteins or any of the ingredients