cyrilzakka/clinical-trials huggingface dataset:
TSK (Tryptophan - Serotonin - Kynurenine) Biomarkers Assessment in Stroke

Single-center, prospective, descriptive and biomedical research with controls, without health product.

Depression is the second risk factor for stroke as tobacco smoking following hypertension. Peripheral abnormalities in serotonin parameters were described in depression and tobacco smoking. The investigators hypothesized dysregulations in pathways of serotonin (5-HT), which has notably complex vasomotor effects and of kynurenine which could have cognitive dysfunction effects.

The aim of this study is to evaluate simultaneously the involvement of serotonin and kynurenine pathways parameters in patients suffering from a cerebral infarction shortly after the onset (less than 4 hours and a half), within a 2 days follow-up (Day 1 and Day 2) and 3 months after the cerebral infarction.

Tryptophan (TRP), an essential aminoacid, is metabolized in the serotonin (5-HT) or in the kynurenine (KYN) pathway. Serotonin is catabolized to 5-HIAA (5-hydroxyindole amino acid) by monoamine oxidase A (MAOA). The TRP to KYN transformation is regulated by indoleamine 2,3-dioxygenase (IDO).

The primary objective was the measurements of serotonin and kynurenine pathways parameters which were performed in blood and urine samples using different HPLC techniques and of serotonin transporters and receptors which were determined in blood platelets. The results in patients were compared to those measured in controls matched for age, gender, tobacco consumption and season of inclusion.

The secondary objective was to evaluate the potential relationships between these 5-HT and Kyn pathways biomarkers concentrations, MAOA and IDO enzymatic activations and clinical outcome and criteria.

Eligibility Criteria:
Study population : patients who had positive MRI diagnosis of cerebral infarction less than 4.30 hours after the clinical onset.

Experimental group :

Inclusion Criteria:

* Age ≥ 18 ans
* Cerebral infarction with a medical care to emergencies less than 4.30 hours after the symptoms onset.
* Written informed consent signed by the patient, or by a trusted person then by the patient himself if permitted by his condition.

Exclusion Criteria:

* Cerebral infarction with a medical care to emergencies more than 4.30 hours after the symptoms onset.
* Patient with subarachnoid haemorrhage, cerebral hematoma.
* Pregnant woman
* Patient under guardianship or trusteeship, or safeguard justice.

Control group :

* Matching criteria for age, gender, tobacco smoking, inclusion season
Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease

This prospective study will evaluate the effect of oral sunflower lecithin dietary supplementation on meibomian gland function in adults with dry eye disease.

Enrolled patients in the active arm of the study (n=20) will receive a daily dose of four sunflower lecithin 1,200 mg soft-gel capsules for a duration of 90 days. Patients in the control arm (n=10) will receive four doses of a 1,000 mg placebo soft-gel capsules (containing olive oil). Patients will be evaluated for meibomian gland function and signs and symptoms of dry eye at baseline and at the end of the study using a standardized eye dryness survey (SPEED survey), Tear Breakup Time Measurement, Meibomian Gland Score, and a rapid in-office assessment of years (InflammaDry).

Eligibility Criteria:
Inclusion Criteria:

* Age greater than18 at the time of informed consent
* Clinical diagnosis of dry eye in both eyes
* Fluorescein tear film break-up time (TBUT) less than 10s in both eyes
* The presence of lid margin scaling, telangiectasia, collarette or meibomian gland plugging on slit-lamp examination
* Best-corrected visual acuity (BCVA, Snellen) of 20/40 or better in each eye
* Patient Evaluation of Eye Dryness (SPEED) questionnaire score \>6 to \<14
* Must understand; be willing and able, and likely to fully comply with study procedures, visit schedule, and restrictions

Exclusion Criteria:

* Any pre-existing ocular disease other than dry eye disease
* Patients with inability to swallow soft gel capsules
* Severe illness, pregnancy or breastfeeding, smoking, and regular use of strongly anticholinergic drugs.
* Drastic change of food and/or food supplements within the last month.
* Other food supplement with fatty acids
* Evidence of acute ocular infection and⁄or intraocular inflammation within 1 month prior to the onset of this study.
* Ocular surgery within the last 6 months.
* Patients treated with topical ocular, steroidal or non-steroidal, anti-inflammatory treatment within the last month.
* Occlusion therapy with lacrimal or punctum plugs within the last 3 months.
* Alterations of the lacrimal drainage system
* Eyelid abnormalities
* Patients on oral tetracycline or corticosteroids
* Active allergy or infection at the ocular surface
Long-term Follow-up of Checkpoint Inhibitors-induced Ileo-colitis

This is a multicentric, observational study, including all European centres willing to take part. The multicentre nature is necessary for enhancing the generalisability of our results, and due to the rarity of this condition. The study is observational including both retrospective and newly diagnosed cases of CIC with an endoscopically/histologically-proven diagnosis. Detailed characteristics will be collected, with the aim of classifying the disorders from a clinical, endoscopic, and pathological point of view. Age, sex, localisation, and histology of tumour, stage of tumour, oncological response to immune checkpoint inhibitors-induced colitis, colonoscopy, histology, inflammatory parameters, and clinical manifestations will be assessed for each patient, as well as therapy and outcome.

The study will consist of 2 part: the first one will be retrospective, while the second one will be prospective al will include all incident patients diagnosed with CIC during the enrolment period.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* patients able to provide informed consent or who have already given leave of use of their data for research in the retrospective part; waiving of the informed consent may be applied if national regulations allow to do so;
* patients who have undergone at least one cycle of immune checkpoint inhibitors before the onset of intestinal symptoms;
* patients with at least one colonoscopy showing macroscopical and/or histological colitis after commencement of immune checkpoint inhibitors therapy; for retrospective patients only, a follow-up of at least 12 months, unless death occurred before.

Exclusion Criteria:

* Evidence of colitis/inflammatory bowel disease prior to checkpoint inhibitors administration
Social and Clinical Aspects of Pelvic Pain in Turkey

Chronic Pelvic Pain (CPP) is a common medical condition with a complex treatment due to different variables that influence its clinical course.There is a growing literature which discussing the effect of ethnicity and culture on pain. It was aimed to invesitigate whether there is a considerable difference in the presentation and experience of pelvic pain in women from a different societies and cultures.

Chronic Pelvic Pain (CPP) is a common medical condition with a complex treatment due to different variables that influence its clinical course.There is a growing literature which discussing the effect of ethnicity and culture on pain. It was aimed to invesitigate whether there is a considerable difference in the presentation and experience of pelvic pain in women from a different societies and cultures.

The study includes randomly selected 45 females who completed a comprehensive set of questions derived from International Pelvic Pain Society (IPPS), pelvic pain assesment form. Character and intensity of pain, sexual abuse and harresment, coping with pain, physical activites (exercising) and comorbidities were evaluated. The McGill pain questionnaire short form was used to evaluate pain. Sexual Abuse Items in the Questionnaire (modified) to assess patients' sexual abuse status.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-65 years with pelvic pain ≥6 months were eligible.

Exclusion Criteria:

* Patient who have had pelvic surgery
* Gynecological female patients with problems other than pelvic pain
An Interactive Web-based Intervention to Achieve Healthy Weight in Young Children

The overall purpose of this study is to develop and implement an effective intervention program designed to prevent and treat obesity in young children.

Study procedures and interventions:

Pre-intervention: a full-day training will occur with a physician and nurse from each clinic site to be trained as "champions" in counseling.

Intervention:

A letter of introduction will be mailed to potential subjects whose child was seen in the last 6 months for a well-child exam whose BMI is greater than or equal to the 85th percentile. After informed consent is obtained, the subjects will be randomized to the intervention or control group. One parent may join the study.

Groups of 10 to 12 parents of overweight and obese 3 to 6 year olds will meet once weekly for 6 weeks at 5:30 to 6:30 pm with the "nurse champion" in the primary care office. Topics to be presented and discussed include authoritative parenting, using the food plan "Go, Slow, and Whoa", increasing physical activity, and behavior change strategies. Sessions will be audiotaped and independently audited to confirm program fidelity. Parenting skills will be discussed at every session.

The intervention group will have access to a website. This site will include information services (instant library with health topics related to nutrition and physical activity and answers to frequently asked questions), web links to other pre-screened sources of information on nutrition and physical activity, local resources for current activities for children and families, personal stories (emphasizing authoritative parenting), interactive discussion group and Ask the Expert (questions will be answered within 48 hours and usually sooner).

Eligibility Criteria:
Inclusion Criteria:

* one parent of a 3-6 year old child with a BMI greater than or equal to the 85th percentile
* Internet access
* English speaking

Exclusion Criteria:

* Children with a developmental disorder
* Children with a chronic underlying disease that may contribute to obesity
* Children taking medication that may interfere with a healthy weight
Colecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)

This is a multi-centre, double blind, randomised, placebo controlled, parallel group, phase 4 pilot study investigating colecalciferol (vitamin D3) as an add-on treatment to subcutaneously administered interferon-beta-1b in relapsing-remitting multiple sclerosis patients.


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 55 years
* remitting-relapsing multiple sclerosis according to McDonald criteria who fulfill the reimbursement criteria for interferon-beta and have used interferon-beta-1b for at least one month
* EDSS (expanded disability statsu scale) ≤ 5
* no neutralising antibodies to INFB as measured by indirect MxA test
* prepared and considered to follow the protocol
* using appropriate contraceptive methods (women of childbearing potential)
* has given informed consent

Exclusion Criteria:

* serum calcium \>2.6 mmol/L
* serum 25(OH)D2 (kalsidiol) \> 85 nmol/L
* presence of primary hyperparathyroidism (serum intact PTH, parathyroid hormone)\>65 ng/L)
* pregnancy or unwillingness to use contraception
* alcohol or drug abuse
* use of glucocorticoid treatment other than intravenous methylprednisolone for treatment of relapses
* current use of other immunomodulatory therapy than interferon-beta-1b
* known allergy to cholecalciferol or arachis oil (peanuts)
* therapy with digitalis, calcitonin or active vitamin D3 analogues during the previous 12 months or multivitamins containing vitamin D during previous two weeks preceding study entry
* any condition predisposing to hypercalcaemia (such as any type of cancer)
* sarcoidosis
* nephrolithiasis or renal insufficiency, serum creatinine above 1.5 times the normal upper reference limit
* significant hypertension (Blood Pressure \<180/110 mmHg)
* hyperthyroidism, or hypothyroidism in the year before the study began
* a history of nephrolithiasis during the previous five years
* cardiac insufficiency or significant cardiac dysrhythmia
* unstable or advanced ischaemic heart disease
* has suffered a major depression
Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059)

The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.

Participants who achieved RVR after 4 weeks of PEG-INF alfa-2b plus RBV treatment were randomized to receive either 20 or 44 weeks of continued therapy, for a total of 24 or 48 weeks total of PEG-INF plus RBV therapy.

Eligibility Criteria:
Inclusion Criteria:

* Participant is ≥40 kg and ≤120 kg weight
* Participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.
* Previously documented CHC genotype 4 infection
* Liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology and with hepatic fibrosis scores (F0, F1, F2, F3).

Exclusion Criteria:

* Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus
* Treatment for hepatitis C with any investigational medication
* Treatment with any investigational drug within 30 days of the screening visit
* Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
* Autoimmune hepatitis or a history of autoimmune disease
* Hepatic fibrosis score F4
* Severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
* Autoimmune hepatitis or a history of autoimmune disease
* Thyroid disease uncontrolled with conventional treatment
* Epilepsy and/or compromised central nervous system (CNS) function
The Effects of Social Media on Food Intake and Behaviour

Participants will be exposed to 3 conditions, in random order:

1. A Facebook page where 70% of posts are related to food.
2. A Facebook page where only 20% of posts are related to food.
3. A control condition (colouring quietly).

During each of the above conditions participants will be provided with identical snacks. The snacks will be weighed before and after each condition, to determine whether there is a change in food intake across the 3 conditions.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-25.

Exclusion Criteria:

* None
OCT or Angiography Guided De-escalation of DAPT

Optical coherence tomography (OCT) offers a high-resolution intravascular imaging modality to accurately assess vessel and lumen geometry and identify the hallmark of a culprit lesion including plaque disruption and thrombus. In addition, the incorporation of the MLD MAX algorithm into daily practice guides an efficient and easily-memorable workflow for optimized OCT-guided percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Regarding the antithrombotic therapy after revascularization, the 2023 ESC guidelines recommend the P2Y12 receptor inhibitor de-escalation (i.e. switching from ticagrelor to clopidogrel) in ACS patients may be considered as an alternative strategy to the default treatment regimen in order to reduce the risk of bleeding events.

Based on the above conclusions, we designed a single-center, prospective, randomized controlled, exploratory study trial to evaluate whether the utility of OCT for guiding PCI with DES followed by antiplatelet de-escalation therapy could further reduce the stent-induced intimal hyperplasia of STEMI patients after stent implantation.


Eligibility Criteria:
Inclusion Criteria:

1. 18 \~ 85 years old adult patients;
2. Patients diagnosed with STEMI and undergoing PCI.
3. Patients able and willing to give written informed consent and to comply with the requirements of this study protocol.

Exclusion Criteria:

1. Prior history of intracranial hemorrhage or ischemic stroke during the past 6 months；
2. Allergy to aspirin or clopidogrel or ticagrelor;
3. Occurrence of major adverse cardiovascular event (MACE) within 30 days after undergoing PCI;
4. Platelet count \< 50 × 109/L;
5. Major bleeding during the past 12 months;
6. Any form of oral, long-term anticoagulation therapy;
7. Pregnancy or lactation;
8. Suspected aortic dissection;
9. Coronary CT-negative patients;
10. Life expectancy \<1 year;
11. Uncontrolled hypertension, systolic blood pressure (SBP) ≥180 mmHg, and/or diastolic blood pressure (DBP) ≥110 mmHg;
12. Comorbid conditions included the presence of any of the following: cardiogenic shock, chronic congestive heart failure with NYHA classes III or IV, left ventricular ejection fraction (LVEF) \< 35% at transthoracic echocardiography, hypotension with SBP \< 90mmHg and/or DBP \< 60mmHg, severe arrhythmia (including high-degree AV block, sick sinus syndrome, sustained ventricular tachycardia), severe pulmonary insufficiency, pulmonary embolism, hepatic insufficiency due to non-cardiac causes (ALT or AST more than three times the upper limit of the institution's normal reference ranges), cirrhosis, severe renal failure (eGFR \< 30ml/min/1.73m2);
13. Surgery plan within 30 days;
14. Psychiatric abnormalities or alcohol dependence;
15. Patients who are participating in other clinical trials;
16. Unable to tolerate 1 month of DAPT;
17. Angiographic triple vessel disease coronary disease;
18. Other situations judged by the investigators not to be suitable for the clinical trial.
the "Level of Resilience" Influencing Self-care in Heart Failure Patients

Adaptation to the new health condition and self-care skills allow people to be able to adhere to the therapeutic treatment in the most correct way possible, but there are many cases in which subjects do not show adherence to it, and for this reason the risk increases to manifest acute complications and also to develop long-term ones

Primary objective

-Evaluate levels of resilience in subjects suffering from heart failure.

Secondary objectives

* Evaluate the levels of self-care in subjects suffering from heart failure.
* Evaluate the correlation between the level of resilience and the level of self-care;
* Evaluate which characteristics positively influence the level of resilience and the degree of self-care of the person with heart failure.

Consecutive patients suffering from heart failure followed at the Cardiology department of the Agostino Gemelli IRCCS University Polyclinic Foundation of Rome will be included

Eligibility Criteria:
Inclusion Criteria:

* Subjects suffering from heart failure;
* Subject aged between \>18 years and \<90 years;
* Ability to understand the Italian language;
* Clinical conditions that allow the questionnaire to be completed;
* Ability to provide written informed consent.

Exclusion Criteria:

* Subjects suffering from other forms of diabetes;
* Subjects suffering from serious psychiatric disorders;
* Serious clinical conditions that do not allow the questionnaire to be completed;
* Inability to provide written informed consent.
Ulnar Nerve Block for Procedural Anesthesia - Wrist Versus Palm

Ulnar nerve blockade is necessary for sensory anesthesia and analgesia in the hand during minor procedures. The course of the ulnar nerve in the forearm, wrist, and hand is predictable and has low variability. However even with known anatomic location and landmarks, ulnar nerve blocks at the wrist frequently are inadequate for procedural anesthesia. The antebrachial fascia at the wrist acts as a barrier to local infiltration. Since the fascia can not be visualized or palpated, it is commonly not penetrated, resulting in an inadequate block. Furthermore at the level of the wrist the ulnar artery lies in close proximity to the nerve and there is potential for arterial puncture while attempting injection for volar wrist block. The palmar ulnar nerve block is an injection distal to the hook of the hamate in the thenar eminence which avoids the ulnar artery and antebrachial fascia. This block has been used successfully for many years in clinical practice but has not been assessed or compared in a research study. The purpose of this study is to assess the validity of using a palmar ulnar nerve block for procedures in the hand as compared to the standard volar wrist ulnar nerve block.


Eligibility Criteria:
Inclusion Criteria:

* any individual who can give informed consent and is scheduled for elective hand procedures by the PI necessitating an Ulnar nerve block of the hand.

Exclusion Criteria:

* patients unable to give informed consent
* patients with previous or ongoing ulnar nerve deficits or neuropathy
* patients undergoing Guyon's canal decompression
* patients who can not comprehend or cooperate with assessment testing
* patients with abnormal two point discrimination (\> 6 mm at the test location) prior to the nerve block
Vitamins and Minerals for Children With Downs Syndrome

The trial aimed to examine the effects of supplementation with antioxidants and folinic acid on the health, growth and psychomotor development of children with Down syndrome. 156 children with Trisomy 21, less than 7 months of age were recruited and randomised into four groups to receive antioxidants, folinic acid, a combination of antioxidants and folinic acid or a placebo. Blinded outcome assessment was carried out 18 months later.Blood and urine samples were also taken around 12 months of age to examine metabolic effects of supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Under 7 months of age
* Trisomy 21
* Live in recruitment Area-i.e. London inside M25, in West Midlands or SW England.
* One parent speaks English

Exclusion Criteria:

* No life threatening cardiac disease
The Correlation Between Adenoid Hypertrophy and Body Temperature in Children Before and After Adenoidectomy

Examination of the correlation between adenoid hypertrophy and body temperature in candidate children for adenoidectomy after exercise

Examination of the correlation between adenoid hypertrophy and body temperature in candidate children for adenoidectomy after exercise.

Adenoid hypertrophy and adenoiditis are accompanied by chronic rhinitis with or without otitis media. It is very common phenomena at ages 2-6 years and those children are symptomatic with snoring, rhinitis, nasal obstruction.

In healthy children with nasal obstruction, body temperature can be elevated following exercise.

As adenoiditis and chronic rhinitis are accompanied by inflammatory process, we would like to examine body temperature of children with adenoid hypertrophy before after exercise.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children with adenoid hypertrophy with or without OSA, SOM Parental concent. No other diseases

Exclusion Criteria:

* Syndromatic children Other diseases If getting antibiotics or other medications