cyrilzakka/clinical-trials huggingface dataset:
The Effect of Glycaemic Index Variation on Blood Glucose and Mood in Healthy Participants Across the Day

This study provided 24 healthy subjects with two diets that varied in their glycaemic index values. One condition was a low GI diet, whilst the other was a high GI diet. Glucose concentrations and mood were measured throughout each test day.

Therefore, the aim of this study is to feed to participants meals which differing in their glycaemic index across the course of a day, and thus produce different glycaemic responses. The outcome variables will be blood glucose levels and subjective mood. The purpose of this study is to identify the appropriate times (according to glycaemic response) at which cognitive functioning should be tested. Importantly, this study is also the first step to characterizing glycaemic and cognitive profiles associated with food consumption over a whole day (breakfast, lunch, snack) rather than just one meal (e.g. breakfast), ranging from the most favourable (stable glucose regulation) to the least favourable (variability; many peaks and troughs).

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65 years of age.
* Willing to participate in the entire study (signed informed consent required)
* Subjects will be eligible for the study if male or female (not pregnant or lactating)

Exclusion Criteria:

* Diabetic
* Smoker
* Have any food intolerances or allergies
* History of alcohol or drug misuse
* Diagnosed with any of the following:

  * High blood cholesterol
  * High blood pressure
  * Thyroid disorder
  * Heart problems, stroke or any vascular disease in the past 12 months
  * Inflammatory diseases such as rheumatoid arthritis
  * Bone related conditions, such as osteoporosis
  * Renal, gastrointestinal, respiratory, liver disease or cancer
* You are presently taking part in another clinical trial or research study
* You are an elite athlete (very high intensity training more than 3 times a week)
* You are currently on a specific diet or taking any dietary supplements and are unwilling to cease during the testing period
* You are intending to regularly use medication which affects gastrointestinal motility
A Performance Evaluation of the LumiraDx Point Of Care D-dimer Assay

In patients with symptoms of Venous Thromboembolism (VTE) (mainly deep vein thrombosis (DVT) or pulmonary embolism (PE)), the study will evaluate the agreement between the D-Dimer measurements from the LumiraDx POC D-Dimer assay and a reference method, as an aid in diagnosis, assessment and exclusion of DVT and PE.

This is a performance evaluation study designed to assess the precision and accuracy of the LumiraDx Point of Care (POC) D-Dimer test when used in patients presenting with symptoms of Venous thromboembolism (VTE), which mainly comprises deep vein thrombosis (DVT) or pulmonary embolism (PE).

The LumiraDx POC D-Dimer test is a quantitative immunoassay providing results in under 10 minutes. The accuracy of the LumiraDx POC D-Dimer test will be assessed using capillary whole blood, venous blood, and plasma samples, by comparison to the D-Dimer results obtained from the same individuals as analysed by trained laboratory professionals using a reference device. The results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test in the European Union (EU) and other relevant geographies.

Adult males and females presenting to the study sites with symptoms of VTE will be included in the study. Approximately 1000 subjects will be recruited in total. An initial analysis will be completed on the first 200 patients to determine accuracy of the LumiraDx D-Dimer test versus the reference method. The study will continue until 1000 patients are recruited and with a minimum of 120 confirmed VTE events, in order to complete retrospective analysis using the LumiraDx D-Dimer cut-off for exclusion of VTE.

Once consent is obtained, blood tube samples will be drawn and finger-stick samples of capillary blood will be taken from the subject, these will be applied directly to unique test strips for immediate measurement of D-Dimer on the LumiraDx POC D-Dimer test.

The D-Dimer results obtained via the LumiraDx D-Dimer test will be used in a set of comparative analyses designed to determine the performance characteristics of the test. This study is an observational, cross-sectional design. As an observational study of an investigative device, results obtained during the course of the study will not inform or alter patient management or treatment decisions in any way.

Eligibility Criteria:
Inclusion Criteria:

Subject is greater or equal to 18 years of age Willing and able to provide written informed consent and comply with study procedures Symptoms of thromboembolic event

Exclusion Criteria:

Suspected Sinus Venous Thromboembolism / Cerebral Venous Sinus Thromboembolism End-stage renal failure on haemodialysis Current anticoagulant therapy (Fragmin, LMWH) within the last 30 days Patient has previously participated in this study Life expectancy documented as \<30 days Haemodynamically unstable (e.g. cardiogenic shock) Patients taking anticoagulant therapy (DOACS, Warfarin, Heparins etc) within the last 30 days Patient deemed medically unfit to participate
Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV

Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV


Eligibility Criteria:
Inclusion Criteria:

* Positive RAST result to birch pollen
* Positive Skin Prick Test reaction to birch pollen
* positive nasal provocation test result to birch pollen extract

Exclusion Criteria:

* serious chronic diseases
* other relevant seasonal allergies
The Effect of Virtual Reality Experience on Infusion-related Pain

This clinical trial aims to analyze the effect of virtual reality experience on infusion-related pain with lumbar epidural catheterization.

Patients with chronic pain are to suffer from acute pain during their chronic pain-relieving interventions. However, there is no active countermeasure against pain during these procedures. This prospective randomized clinical study seeks to find an appropriate solution to the procedure related acute pain of these patients by actively utilizing virtual reality experiences.

Eligibility Criteria:
Inclusion Criteria: If all of the following conditions are met

* A person with chronic low back pain that lasts more than 3 months due to spinal stenosis or lumbar disc disease.
* Adults over 20
* Those who decided to participate out of his/her own free will and signed in written consent

Exclusion Criteria: If the patient meets one or more of the following criteria, He or She cannot participate this clinical trial.

* In case of contraindication to general lumbar catheterization (e.g. coatulopathy, infection, etc)
* Hearing and vision impairments
* Affective disorder
* History of epilepsy or seizure
* If communication is not possible due to impaired cognitive ability
* Those who have been deemed inappropriate by the researchers
Treatment Of Unstable Trochanteric Fracture: A Comparative Study Between DHS And DHS With Trochanteric Stabilization Plate

compare the results in treatment of unstable trochanteric fracture by using DHS and DHS with Trochanteric Stabilizing plate as regard shaft medialization.neck shaft angle measurment and shaft migration


Eligibility Criteria:
Inclusion Criteria:

* pateints with comminution of medial femoral cortex and loss of continuity of lesser trochanter

Exclusion Criteria:

* stable trochanteric fracture subtrochanteric extension reverse oblique trochanteric fracture
Intact Abdominal Aortic Aneurysm Repair in Portugal

Abdominal aortic aneurysm (AAA) repairs registered in the hospitals administrative database of the National Health Service from 2000 to 2015 were retrospectively analyzed regarding demographics (age and gender) and type of repair (open surgery \[OS\] or endovascular repair \[EVAR\]). Rate and mortality were compared among three time periods: 2000-2004, 2005-2009 and 2010-2015.

All AAA interventions performed during the period 2000 to 2015 were retrospectively identified in a National Health Service (NHS) administrative database, the hospital morbidity database, formerly designated as Diagnosis-Related Groups (DRGs) database. This database was provided by the Portuguese Central Health System Administration (ACSS) and contains a registration of all hospitalizations (retrospective consecutive case entry) occurring in public hospitals in mainland Portugal.

Each episode includes information about diagnoses (primary and secondary diagnoses) and medical or surgical procedures, both coded using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9).

All admissions considered have a primary diagnosis ICD-9 codes for ruptured and non-ruptured AAA. The primary diagnosis of an episode represents the main condition investigated or treated during that hospital stay.

The rate of the repair was calculated based on the episodes of care with the above-mentioned disease ICD-9 codes plus the ICD-9 procedure codes suitable for AAA repair. Admissions with a primary diagnose of AAA that lacked a ICD-9 procedure code suitable for AAA repair were excluded, assuming that no repair was performed during that hospital stay. General indication for iAAA repair in Portugal are a maximum transverse diameter ≥5.5cm in men and ≥5.0 cm in women, as recommended by guidelines.

The number of deaths accounted for all patients that fail to be discharged alive from the hospital admission where the repair took place, irrespective to the direct cause of death. The number of admissions for repair in which the patient died divided by the number of all admissions for repair was used as a proxy of in-hospital mortality due to iAAA. The number of resident population in each year under analysis was provided by the National Institute of Statistics (INE) from 2000 to 2015. Resident population per year was used to calculate the rate of AAA repair and the death associated with AAA repair (thereafter mentioned as mortality to distinguish from the above-mentioned in-hospital mortality).

Death certificate with AAA-specific mortality was provided from the National Institute of Statistics (INE) from 2000 to 2015. INE data includes deaths outside the hospital besides those certificated at the hospitals.

In both databases, patients \<50 years of age were excluded.

Eligibility Criteria:
Inclusion Criteria:

* Patients submitted to abdominal aortic aneurysm repair in Portugal from 2000-20015

Exclusion Criteria:

* Patients without abdominal aortic aneurysm
Increasing the Oral Bioavailability of 6-prenylnaringenin by Micellar Solubilization

Micellar encapsulation will be tested to increase the oral bioavailability in humans of 6-prenylnaringenin (6-PN) from hops (Humulus lupulus). The study follows a single dose (250 mg 6-PN), placebo controlled, randomized, double-blind, three armed crossover study design with ≥2-week washout periods. Plasma, urine and PBMC samples will be collected at intervals up to 24 h after intake of the native compound, the micellar formulation or placebo. The safety, pharmacokinetics and impact of oral prenylflavonoids on PBMC survival will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with blood chemistry values within normal ranges
* Age: 18-45 years
* BMI: 19-25 kg/m2

Exclusion Criteria:

* Pregnancy or lactation
* Alcohol and/or drug abuse
* Use of dietary supplements or any medications, except contraceptives
* Any known malignant, metabolic and endocrine diseases
* Previous cardiac infarction
* Dementia
* Participation in a clinical trial within the past 6 weeks prior to recruitment
* Physical activity of more than 5 h/wk
A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease

This is a study where AZD3241 or placebo is given to patients with Parkinson's disease in a blinded and randomized assignment. The main objective is to see if safety and tolerability of the drug is acceptable.

A Phase IIa, 12 Week, Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral AZD3241 in Patients with Parkinson's Disease

Eligibility Criteria:
Inclusion Criteria:

* Each patient must be able and willing to provide signed and dated informed consent prior to the study.
* Female and male patients aged 30 to 80 years at the day of enrollment (Visit 1).
* Patients must meet the criteria for "Diagnosis of idiopathic Parkinson's disease" according to the UKPDS Brain Bank criteria (Hughes et al 1992).
* Have a modified Hoehn and Yahr stage 1-2.5.
* Having no treatment for Parkinson's disease and have no need to add anti-Parkinson's disease treatment during the 14 weeks of study OR are on stable anti-Parkinson's disease medication.

Exclusion Criteria:

* Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes or heredodegenerative diseases.
* Have undergone surgery for the treatment of Parkinson's disease (eg, pallidotomy, deep brain stimulation, fetal tissue transplantation) or have undergone any other brain surgery at any time, even for non-Parkinson's disease conditions.
* Presence of dyskinesias, motor fluctuations, swallowing difficulties or loss of postural reflexes, defined as scoring 2 or more on item 30 of the UPDRS.
* Current/history of psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses, i.e. bipolar disorder or MDD, or other psychiatric, neurological or behavioral disorders/symptoms that may interfere with conduct of study.
* Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, hematological disease, hepatic disease, renal disease, gastrointestinal (GI) disease, or other major disease as judged by the investigator.
Efficacy and Safety of Resveratrol and Carbossimetyl Beta Glucan in Treatment of Upper Airways Disease in Infancy

outpatient infants (0-6 months of life), affected by symptoms of upper airways disease will be randomly assigned to two type of intervention:

A: treatment group, receiving resveratrol and carbossimetyl beta glucan; B: control group, receiving saline solution.

Each subject underwent clinical history, objective examination and detection of rinovirus in the nasal secretions at enrollment, after 48 hours and after 7 and 30 days.

Consecutive outpatient infants (0 - 6 months) with common cold symptoms were enrolled and randomly divided into two groups: resveratrol plus carboxymethyl-β-glucan solution or saline isotonic solution randomized treatment (3 drops in each nasal fossa, 4 time daily for seven days).

Each patient underwent clinical evaluation at enrollment, after 48 hours and after 7 and 30 days.

Common cold symptoms were specifically evaluated according to CARIFS Scale. Nasal swabs for HRV research will performed at enrollment, after 48 hours and after 7 and 30 days.

Eligibility Criteria:
Inclusion Criteria:

* common cold syndrome

Exclusion Criteria:

* main comorbidities
SLN Mapping and ICG Dye for Vulvar Cancer

Doctors typically use blue dye to assist in locating and extracting lymph nodes for biopsy. However, this process can prove somewhat challenging for both patients and medical teams due to its need for extensive coordination and the assistance of a nuclear medicine team. Some studies have talked about using a different method to find these lymph nodes using a special dye called Indocyanine Green (ICG). This method involves shining a special camera on the skin. So far, no studies have directly compared the ICG method to the standard blue dye. The ICG camera could make things easier for patients and doctors, and more patients might choose to have their lymph nodes checked with this new method. The goal of our study is to see if using the ICG dye is just as good as the standard method of blue dye.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patients with early-stage SCC (diameter \<4 cm) of the vulva without suspicious lymph nodes at palpation or imaging who are planned for surgery at Tufts Medical Center.
* Patients with squamous cell carcinoma, depth of invasion \> 1mm
* Patients with T1 or T2 tumors (FIGO staging) \< 4 cm, not encroaching in urethra or anus with clinically negative inguinofemoral lymph nodes
* Localization and size of the tumor are such that perilesional injection of the tracers at three or four sites is possible
* Preoperative imaging do not show enlarged (\<1.5 cm)/ suspicious nodes
* Willing and able to give informed consent

Exclusion Criteria:

* Inoperable tumors and tumors with diameter \> 4 cm
* Patients with inguinofemoral lymph nodes that are palpable on clinical exam suspicious for metastases or with cytologically proven inguinofemoral lymph node metastases
* Radiologically enlarged (\>1.5 cm) inguinofemoral lymph nodes
* Patients with multifocal tumors
* Pregnancy
Study of Memantine Augmentation in Severe Obsessive-Compulsive Disorder

Memantine is a glutamate receptor antagonist that has been reported to reduce Obsessive-Compulsive Disorder (OCD) symptoms in case studies of treatment-resistant individuals. The investigators hypothesized that memantine is an effective augmenting agent to standard intensive residential treatment of severe OCD. An intent-to-treat, single-blinded, naturalistic case-control design is employed. The sample includes subjects receiving standard treatment at the McLean/ MGH Intensive Residential Treatment (IRT) program, half of whom also receive memantine augmentation. Admission, monthly and discharge measures of OCD, depression and psychosocial functioning are collected by raters blinded to augmentation status. Matched controls are selected based upon gender, initial OCD severity, psychosocial functioning, and timing of admission. Descriptive and comparative analyses are conducted via SPSS, statistical significance is defined at p\<0.05, clinically significant response is defined by a 25% reduction, and 'marked response' is defined by a 50% improvement in Yale-Brown Obsessive Compulsive severity (Y-BOCS) scores, using a last-observation-carried-forward approach. The Clinical Global Improvement (CGI) scale captures global clinical change.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients of IRT at the OCD Institute who agreed to augmentation with memantine.
* Consecutive patients of IRT at the OCD Institute who were not offered augmentation with memantine and who were matched according to OCD severity, gender, and psychosocial functioning.

Exclusion Criteria:

* Subjects offered memantine augmentation who did not provide voluntary consent.
Effects of Choice Bundling on Valuation of Delayed Gains and Losses in Cigarette Smokers

The present study will investigate the effects of choice bundling, in which a single choice produces a series of repeating consequences, on valuation of delayed monetary gains and losses in an online panel of cigarette smokers.

Choice bundling, in which a single choice produces a series of repeating consequences, has been shown to increase valuation of delayed monetary and non-monetary gains. Interventions derived from this manipulation may be an effective method for mitigating the elevated delay discounting rates observed in cigarette smokers. No prior work, however, has investigated whether effects of choice bundling generalize to reward losses. In the present study, an online panel of cigarette smokers, recruited using Ipsos, will complete assessments for either monetary gains or losses (randomly assigned). In Step 1, participants will complete a delay-discounting task to establish Effective Delay 50 (ED50), or the delay required for a monetary outcome to lose half of its value. In Step 2, participants will complete three conditions of an adjusting-amount task, choosing between a smaller, sooner (SS) adjusting amount and a larger, later (LL) fixed amount. The bundle size (i.e., number of consequences) will be manipulated across conditions, where a single choice will produce either 1 (control), 3, or 9 consequences over time (ascending/descending order counterbalanced). The delay to the first LL amount in each condition, as well as the intervals between all additional SS and LL amounts (where applicable), will be set to individual participants' ED50 values from Step 1 to control for differences in discounting of gains and losses.

Eligibility Criteria:
Inclusion Criteria:

* currently smoke at least 10 cigarettes per day
* have smoked at least 100 cigarettes (lifetime), and
* are 21 years of age or older.

Exclusion Criteria:

* Inaccurate identification of usual brand cigarette's as menthol or non-menthol
Measuring Skin Elasticity in Lymphedema Patients

This protocol will utilize the lymphedema indentometer, or durometer (a novel, noninvasive piece of equipment that measures skin elasticity), to better characterize disease progression in patients with lymphedema. Beth Israel Deaconess Medical Center patients who undergo treatment of lymphedema will be candidates for this noninvasive test. This device and the data it generates will help understand the incidence of lymphedema at Beth Israel Deaconess Medical Center compared to national data and the outcomes of surgical treatment of lymphedema.


Eligibility Criteria:
Inclusion Criteria:

* Patients evaluated by the Beth Israel Deaconess Medical Center Lymphedema team with a diagnosis of lymphedema OR determined to be at risk of developing Lymphedema in any of their extremities
* Patients must be over 18 years of age
* Patients must be willing and capable to provide informed consent
* Patients must speak English

Exclusion Criteria:

* None
Evaluation of the Effectiveness of a Diagnostic Kit in the Etiological Diagnosis of Fevers of the Traveler

Annually about 10 to 15 million international travelers from Europe visit tropical countries. Returning from a journey, fever is the cardinal symptom of many infections. This is the second reason for consultation (23%) for return from a trip, after digestive disorders (42%). Urgent evaluation must always be proposed. Although that may be the manifestation of a benign disease, fever of return can also presage a rapidly progressive and lethal disease. In 50% of cases, patients return home, after treatment and disappearance of symptoms, though the microorganism responsible for the pathology is not able to be identified. The prescription of a series of systematic biological examinations in the form of a diagnostic kit has shown its relevance and its effectiveness in improving the etiological diagnosis of endocarditis and pericardites for optimal support. In this study we propose to assess the effectiveness of the systematic prescription of a diagnostic kit 'fever of the traveler' to all patients hospitalized with a fever after returning from a trip. "Ready to use" kit brings together in a single bag (i) instructions for use, (ii) the tubes, bottles and jars for the etiological diagnosis of fever of the traveler in the usual support (iii) an additional blood tube for research of pathogens emerging.

Primary:

To assess the effectiveness of a diagnostic kit for the etiological diagnosis of fevers of travelers on the return.

Hypothesis:

Improvement of at least 15% of the etiological diagnosis of fevers of travelers on the return through the development of a diagnostic kit.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a T \>38.5 ° C with or without associated clinical signs.
* Patient who traveled outside metropolitan France within 45 days with the hospitalization.
* Patient is more than 18 years old.
* Patient who accept to have his medical records reviewed for research.
* Patient with health insurance

Exclusion Criteria:

* a feverish syndrome beyond 45 days after the return of their journey.
* a clinical symptomatologie on the return to journey without associated fever,
* minor(miner) ( 18 years).
* Pregnant or breast-feeding woman.
* Incapable major patient or outside state to express its consent.