cyrilzakka/clinical-trials huggingface dataset:
A New Dual Task Test Method for Football Players

Multitasking (Dual Task) is a measurement method to evaluate cognitive ability to execute multiple functions at the same time. To perform this test, while participant/patient performing a main skill (for example, walking), a cognitive skill is added (for example, counting 7 backwards from 100) to measure how much the completion performance of the activity is affected. Frequently used multitasking trainings are known as counting back from 100 and asking mathematical equations during a physical skill. Multitasking skill is rarely used in sports-related training, and it is generally used in the form of counting 7 backwards from 100, counting months and counting 5-letter words while walking over obstacles. However, multitasking training methods described and applied in the literature are not specific to football skills. For this reason, limited tests defined and applied in other clinical and sportive fields may not be sufficient in football players who perform activities that require high performance. Therefore, aim of this study is to develop a dual-task assessment method, which includes the cognitive loads experienced by football players during training and matches, and also covers the basic skills of football. As a result of this study, a football-specific dual-task test will be created and the capacity of the athletes will be measured by applying this test to healthy athletes. Also, this test will be conducted on football players with recent knee injury history, who wish to return to sport, and to evaluate their dual-task capacity and to correlate it with kinesiophobia and other performance tests


Eligibility Criteria:
Inclusion Criteria:

* attending regularly to the trainings
* being a professional football player

Exclusion Criteria:

* having any neurological disorders
Evaluating Stress Management Among Allogeneic HCT Caregivers

The purpose of the study is to understand whether different stress management interventions impact stress among HCT cancer caregivers and patients.


Eligibility Criteria:
Inclusion Criteria:

* Caregiver Inclusion Criteria:
* Caring for a patient planning to receive an allogeneic HCT at Moffitt
* Intending to remain primary caregiver throughout patient treatment (i.e., will be the caregiver the majority of the time)
* Able to provide informed consent
* Able to read and write in English
* Owns a smartphone and is willing to download the study app
* Patient Inclusion Criteria:
* Receiving an allogeneic HCT at the cancer center
* Able to provide informed consent
* Able to read and write in English

Exclusion Criteria:

* Under 21 years of age
* Unable to provide informed consent
* Unable to read and write in English
* Caregiver is unable to remain primary caregiver throughout patient treatment
* Patient does not receive transplant at Moffitt Cancer Center
Cannabidiol for Anxiety

This pilot trial seeks to investigate the effect of 25 mg full-spectrum CBD soft gel capsules (up to a total dosage of 100mg per day) on individuals with diagnosed anxiety. All participants will take CBD soft gel capsules for 12 weeks, and will be assessed at 6 weeks and 12 weeks post-enrollment using measures of anxiety, sleep and perception of change.


Eligibility Criteria:
1. Male or female patients 18 years of age or older with a GAD-7 score of 10 or greater
2. Presenting to a participating clinic for initial evaluation for a medical cannabis card
3. Willingness to abstain from the use of all other cannabis products for the trial period (3 months)
4. Not pregnant or planning to become pregnant during the trial period (3 months)
5. Not breastfeeding or planning to breastfeed during the trial period (3 months)
6. No history of cannabis use within 4 weeks of enrollment
7. No history of lifetime cannabis use disorder or other substance use disorders (except: tobacco use disorder)
8. No history of lifetime daily cannabis use
9. No family history of psychosis (e.g., bipolar disorder or schizophrenia)
10. No history of adverse reactions to cannabis
11. No recent changes to prescribed anxiety medications (within the last 1 month)
12. Provision of informed consent
Validation Study CARES

This study aims to validate the CARES, a needs assessment instrument which can be used to inventorize cancer patients biopsychosocial distress and care needs.

* QUANTITATIVE PART OF THE STUDY: Patients need to fill in a questionnaire package containing questions about social-demographic and medical data, the CARES and convergent measures: Karnofsky Performance Scale (KPS), Hospital Anxiety Depression Scale (HADS), Social Support List (SSL), Maudsley Marital Questionnaire (MMQ), European Organisation for Research and Treatment of Cancer Quality Of Life Core 30 (EORTC-QOL-C30), Distress Thermometer (DT) and a Care Needs Questionnaire. One week after the first questionnaire package participants have to fill in the CARES a second time and answer some questions to evaluate the feasibility of the CARES.
* QUALITATIVE PART OF THE STUDY: Participants from the quantitative part of the study and other (ex-) cancer patients who not have to fulfill the criteria of age and cancer stage can participate in a focus group interview. In these focus groups the content validity and preferences on psychosocial screening in care are discussed.


Eligibility Criteria:
Inclusion Criteria:

* Primary cancer diagnosis stage I, II, III
* All types of cancer

Exclusion Criteria:

* Having had or premorbid neurological problems or cognitive dysfunctions.
* The lack of proficiency in Dutch (Flemish).
Burden of Ischemic Stroke and Intake of Oral Anticoagulants in Patients With Atrial Fibrillation in the UK Primary Care

This study will characterize patients with ischemic stroke, a condition which occurs when a vessel supplying blood to the brain is obstructed, and a subpopulation of patients with irregular and often rapid heart rate (atrial fibrillation) in a UK general population using The Health Improvement Network (THIN) database.

The main aim of the study is to estimate in how many patients atrial fibrillation was diagnosed at the moment of stroke and to describe whether these patients received OAC at the time of the stroke. In addition, researchers want to learn about the relative risk of ischemic stroke when such patients did not continue OAC treatment.

The primary objectives of the study are to determine the incidence of ischemic stroke in patients registered in the British primary care THIN database and to investigate the OAC exposure, OAC treatment patterns and the relative risk of having an ischemic stroke in relation to OAC treatment for a subgroup of patients, who were diagnosed with non-valvular atrial fibrillation (NVAF) prior to ischemic stroke.

Secondary objectives are to determine the number of patients having NVAF diagnosed at the time of ischemic stroke and within 1 and 12 months after ischemic stroke; to describe cardiovascular risk factors for ischemic stroke and pharmacological treatments before and 12 months after ischemic stroke, and to estimate the case-fatality at 1 and 12 months after the occurrence of ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* Occurrence of an ischemic stroke that lead to hospitalization between 01-Jul-2016 to 30-Jun-2018 and concerned adults registered in the THIN database
* Subgroup: Patients with diagnosed NVAF prior or at the time of ischemic stroke

Exclusion Criteria:

* None
Propionic Acid in Multiple Sclerosis

The purpose of this study is to demonstrate the superiority of propionic acid over placebo as add on treatment in multiple sclerosis (MS).

This is a single-center, double-blinded, randomized trial. One hundred multiple sclerosis (MS) patients will be randomly assigned in a 2:1 ratio to receive either 100 mg of propionic acid or a placebo over a period of 90 days. Outcome measures will encompass NfL and GFAP levels, fatigue scores, quality of life assessments, and physical examinations. Additionally, subgroup analysis will involve the evaluation of MRI and MEG data.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis (MS)
* Clinically and radiologically stable MS in the previous 3 months
* Age between 18 and 60 years
* Positive finding for oligoclonal bands (OCBs)
* Written consent
* Blood collection at the beginning and end of the study for routine parameter examination as well as sample preservation (especially for measuring propionic acid levels)
* Negative pregnancy test for female participants of childbearing age

Exclusion Criteria:

* Existing propionic acid supplementation
* Change in disease-modifying therapy (DMT) in the previous 4 weeks
* Existing severe systemic diseases
* Presence of other concomitant structural nerve diseases (e.g., polyneuropathy, brain tumor, strokes)
* High JCV titer under Natalizumab
Online Interplay Between Deciding and Acting with Mild Cognitive Impairment

The investigators aim to understand the interplay and neural structures involved with decision--making and movement for participants with mild cognitive impairment. Rapidly deciding and acting becomes bottlenecked with mild cognitive impairment and Alzheimer's, leading to detrimental outcomes such as falling and car crashes. The investigators work will have a tangible impact by discovering sensitive biomarkers to detect disease onset and pave the way for informed and effective neurorehabilitation.

Mild cognitive impairment leads not only to impaired decision making, but also movement deficits that predict the development of Alzheimer's disease. Recent behavioral work has suggested a common mechanism that throttles the speed of both decisions and reaching movements, which is supported by converging neural evidence that finds an interac-tion between decision making and movement (motor) circuits. Yet it remains unknown how the interplay between decision making and motor neural circuits becomes impaired and impedes rapid responses for those with mild cognitive impairment. Here the investigators test the central hypothesis that there is an impaired interaction between decision making and motor neural circuits with mild cognitive impairment.

First, the investigators will use human reaching experiments to establish that mild cognitive impairment disrupts the interplay of decision making and motor control. Second, the investigators will use Magnetic resonance elastography to elucidate whether brain stiffness in decision making and motor brain regions are related to altered movement behavior. The expected outcome is a mechanistic understanding of how impaired decision making and motor neural circuits impact movement for those with mild cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

1. age 45 - 90 years
2. Perfect or corrected vision
3. Ability to reach
4. Neurotypical Age-Matched control participants - No history of neurological disorders or injury.
5. Mild Cognitive Impairment participants - clinical diagnosis of amnestic mild cognitive impairment.

Exclusion Criteria:

1. Any injury or condition that impacts reaching
2. Traumatic brain injury, such as concussion, in the last 6 months.
3. Neurotypical Age-Matched control participants: Modified Telephone Interview for Cognitive Status (TICS-m) score \< 34
4. Mild Cognitive Impairment participants: Modified Telephone Interview for Cognitive Status (TICS-m) score \> 34
5. Mild Cognitive Impairment participants: Mini-Mental State Examination Second Edition (MMSE-2) score \< 21.
Comparison of Clinical Effect Between Endoscopic and Microscopic Ear Surgery of Cholesteatoma: A Multicenter Retrospective Observational Study

Background: Cholesteatoma is a potentially life-threatening inflammatory lesion that causes hearing loss, ear discharge, and ear pain, and serious complications. For the past several decades, most studies of cholesteatoma have been restricted to microscopic ear surgery. However, a growing body of evidence suggests endoscopic ear surgery is a safe, minimally invasive approach for cholesteatoma management. This thesis aim to investigate and compare the clinical effect between endoscopic and microscopic ear surgery of cholesteatoma.

Materials and methods: The retrospective study included 186 patients with cholesteatoma who received endoscopic or microscopic ear surgery from 11 otorhinolaryngology centers between November 2016 and March 2021. Patients were followed-up for at least 1 year. Audiometry improvement, treatment cost, time, graft success rate and recurrence rate were assessed after surgery.


Eligibility Criteria:
Inclusion Criteria:

* postoperative pathologically were confirmed cholesteatoma with or without mastoid involvement
* the extent of disease was confirmed by preoperative HRCT temporal bone
* undergoed microscopic and/or endoscopic surgery for cholesteatoma including primary or revision surgery

Exclusion Criteria:

* were lacking in clinical characteristics
* had not preoperative audiometric data
* missed the follow-up data
* were lacking in surgical times
* were microscopic combined endoscopic ear surgery
Metformin in Non Small Cell Lung Cancer (NSCLC)

The goal of this clinical research study is to learn if giving metformin in combination with radiation therapy is more effective than radiation therapy alone. In this study, participants will receive either metformin or a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

This is an investigational study. Metformin is FDA approved for the treatment of diabetes. Its use in this study to be given with radiation therapy to treat lung cancer is investigational. The study doctor can explain how the study drug is designed to work.

Up to 70 participants will be enrolled in this study. All will take part at MD Anderson.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with pathologic diagnosis of lung NSCLC or squamous cell carcinoma.
2. Patients are to be treated with hypofractionated RT.
3. Patient is not a surgical candidate due to medical comorbidities determined by a thoracic surgeon or patient refusal
4. Patient plans to receive treatment at MD Anderson
5. Patients must sign informed consent
6. Patient must have adequate renal function within 30 days prior to registration, defined as serum creatinine within normal institutional limits or creatinine clearance at least 60 ml/min

Exclusion Criteria:

1. Patient has: random glucose \>200 mg/dl or is taking an oral hypoglycemic agent or insulin at the time of study entry
2. Patient has a history of lactic acidosis, chronic kidney disease or a creatinine \>/= 1.2 mg/dl
3. Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to the participant, embryo, fetus, or nursing infant
4. Patients with history of allergic reaction to metformin
Efficacy of PegIntron (Peginterferon Alfa-2b) and Rebetol (Ribavirin) in Treatment-naïve Subjects With Chronic Hepatitis C in Clinical Practice in Greece (Study P05209)

The objective of the study is to evaluate the rates of Hepatitis C virus (HCV) eradication and relapse in participants treated with PegIntron and Rebetol in clinical practice in Greece. Participants will not be treated as part of the study. Data on participants treated in accordance with approved labeling will be collected retrospectively from approximately 30 sites in Greece.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have already begun Summary of Product Characteristics (SmPC)-based combination treatment with pegylated interferon alpha-2b and ribavirin, prior to the site initiation date.
* Participants who have been receiving combination treatment with pegylated interferon alpha-2b and ribavirin for at least 6 months before enrollment.
* Participants who have achieved negative HCV RNA at the end of treatment, defined according to genotype (24 weeks for HCV genotypes 2/3 and 48 weeks for genotypes 1/4).
* Participants with diagnosed chronic hepatitis C (CHC) and HCV genotype 1, 2, 3 or 4.
* Participants older than 18 years, regardless of gender or race.

Exclusion Criteria:

* The participant has received treatment for CHC in the past (not treatment-naive).
* The participant has received treatment in the context of a clinical trial in the participating site.
* The participant has been diagnosed with a concomitant infection e.g. with hepatitis B or HIV
* The participant has de-compensated liver disease or belongs to a special population, such as liver transplant, hemophilia, severe pre-existing psychiatric disorder, auto-immune disease, thalassaemia.
* The participant has positive HCV RNA at the end of treatment.
* Pregnant women or women intending to bear children or sexual partners of women wishing to bear children and for a 7-month period after the end of treatment, as indicated in the SmPC of Rebetol.
* The participant is not eligible on grounds of contra-indications, special warnings, particular population and/or the section on pregnancy and lactation of the SmPC.
* The participant has interrupted treatment for any reason.
The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation.

The goal of this clinical trial is to compare effectiveness between epidural combined with TAP block versus epidural alone in gynaecology operation participant .The main question\[s\] it aims to answer are:

* what is the pain score for both groups
* what is the requirement of epidural infusion between the 2 groups Participants will be given general anesthesia for the operation with the epidural insertion prior to induction. Patient will be randomized into epidural plus TAP block or epidural alone for the study. The US TAP block will be given at the end of operation prior to extubation.

Researchers will compare pain score, epidural infusion requirment between the two groups.

The research is a prospective randomized control study. It is blinded study as accessor is blinded whereby the acute pain service (APS) team will be reviewing patient postoperatively.

Study size of 46 subjects based on repeated measure ANOVA between factor , alpha value 0.05% with 80% power study, a dropout 10%. Divided into 2 groups ; Group E - epidural alone, Group T - epidural plus bilateral US TAP block.

Perioperatively, epidural catheter will be inserted then induction for general anesthesia given. Intraoperatively anesthesia maintain with inhalation agent. Prior to extubation, bilateral TAP block is provided using portable US guidance. At this location, the 3 layers of anterior abdominal wall is visualized for the truncal block. Post operatively, participant will be given epidural cocktail bupivacaine 0.1% + fentanyl 2mcg/ml infusion for next 24hrs.

The APS team will review patient post operatively in ward and all data will be recorded. Participation of patient's during study is approximately 2 days duration.

Eligibility Criteria:
Inclusion Criteria:

* Elective major laparotomy gynaecology procedure.
* Age 18 years and above
* ASA I, II, III

Exclusion Criteria:

* Prolonged INR
* Allergic to LA
* History of chronic pain
* Psychological disorder/addict to opioid or benzodiazepine
* Any contraindication for epidural or TAP block procedure
* Pregnancy
Spectrophotometric Evaluation of Chlorhexidine Pigmentations After Oral Surgery: a Prospective Randomized Clinical Trial

The aim of this clinical trial was to evaluate through a clinical spectrophotometric analysis the staining side effect of a 0.2% CHX mouthwash containing an anti discoloration system (ADS) compared with a 0.12% and a 0.2% CHX alone mouthwash after periodontal surgery. The efficacy of the products and the patient's opinion and acceptance were also assessed.


Eligibility Criteria:
Inclusion Criteria:

* Good general health conditions without a medical history of medication that might interfere with periodontal tissues
* Good plaque control (FMPS ≤ 25%) and low levels of infection (FMBS ≤ 25%)
* Need for periodontal surgery

Exclusion Criteria:

* Smokers
* Allergy to CHX
* Lack of written informed consent
Magnetic Resonance Enterography in Inflammatory Bowel Diseases

Assess the accuracy of magnetic resonance-enterography in predicting the extension, location and characteristics of the small bowel segments affected by Crohn's disease\& determine the diagnostic performance of standard MR enterography in detecting colonic inflammation and investigate MR enterography's ability to grade inflammatory activity and detect intestinal extra intestinal manifestations

Inflammatory bowel diseases (IBD) are chronic disorders of the gastrointestinal tract with a remitting-relapsing disease pattern. Ulcerative colitis (UC) and Crohn's disease (CD) represent the two main forms of IBD.

In CD inflammation affects various parts of the bowel, separated by unchanged intestinal segments, while in ulcerative colitis enteric involvement is continuous, extending from the rectum throughout the colon. Additionally, in Crohn's disease the inflammatory process spreads through all layers of the intestinal wall, while in UC only the mucosa and sub mucosa are affected.

Imaging findings, endoscopic studies and histological data together with clinical assessment, can be used to help distinguish these two forms, determine prognosis, assess disease activity and to inform treatment decision-making.

A "treat-to-target" strategy with close monitoring of intestinal inflammation is recommended in inflammatory bowel disease (IBD). Ileocolonoscopy (CS) remains the gold-standard for assessing disease activity in IBD but is a relatively invasive procedure and is impossible to repeat in the context of tight monitoring strategies.

MRE is preferred over computed tomography enterography by most radiologists and gastroenterologists because of the potential for differentiating active inflammation from fibrotic strictures, and due to the lack of exposure to ionizing radiation. This is especially true in children, as the onset of IBD in childhood is a known risk factor for high cumulative exposure to ionizing radiation from imaging.

MRE furthermore provides a transmural study of bowel loops (oedema, wall thickening, and enhancement post contrast). These features make MRE ideally suitable to the IBD population.

Eligibility Criteria:
Inclusion Criteria:

* Patients with different age groups and both sex are eligible for our prospective study

  1. Either they had undergone colonoscopy or colonoscopy was planned, and they have been recently diagnosed with IBD.
  2. Suspected to have disease relapse.

Exclusion Criteria:

Participants are not eligible for our prospective study if they:

1. Have evidence of severe or uncontrolled systemic disease that rendered the individual unsuitable for participation.
2. Have contraindications to MRE (e.g. allergy to all suitable contrast agents, cardiac pacemaker, severe claustrophobia, an inability to lie flat).
3. Had a final diagnosis other than IBD.