cyrilzakka/clinical-trials huggingface dataset:
Plant Based Extracts and Cognition

Acute, randomized, placebo controlled, double blind, 4 arm crossover study to determine the effect of different combinations of plant based extracts on cognitive function and cerebral blood flow.

The objectives of this study are to assess the effects of oral consumption of three differing combinations of plant based extracts, on cognitive function and cerebral blood flow (using Near infrared Spectroscopy) in comparison to placebo. The primary outcome will be change in cognitive function and mental fatigue during extended performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 hours post- consumption.

Eligibility Criteria:
Inclusion Criteria:

* Are over 18 or under 49 years of age
* Self-report of good health
* Are not excluded on the basis of the following exclusion criteria
* English is first language (some of the cognitive tests have only been validated in native English speakers)

Exclusion Criteria:

* Are below 18 or above 49 years of age
* Are a smoker
* Have food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff
* Currently take medication except the contraceptive pill
* Have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total)
* Have sleep disturbances and/or are taking sleep aid medication
* Have a Body Mass Index (BMI) outside of the range 18-35 kg/m2
* Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg)
* Have a history of neurological, vascular or psychiatric illness including epilepsy or seizures (excluding depressive illness and anxiety)
* Have a current diagnosis of anxiety or depression
* Are pregnant, trying to get pregnant or breast feeding
* Have a recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as more than 60g (men) / 40g (women) pure alcohol per day (7 / 5.5 units)
* Are (or are seeking to become) pregnant or are lactating
* Have learning difficulties, dyslexia or colour blindness
* Have visual impairment that cannot be corrected with glasses or contact lenses
* Have frequent migraines that require medication (more than or equal to 1 per month)
* Have disorders of the blood
* Have a heart disorder or a history of vascular illness
* Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study)
* Have type I or type II diabetes
* Have a history of renal or hepatic disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalciuria), that are likely to interfere with metabolism/absorption/secretion of the product under investigation
* Have any health condition that would prevent fulfillment of the study requirements
* Are currently or have in the past 4 weeks participated in other clinical or nutrition intervention studies
* Do not have a bank account (required for payment)
Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure.

This observational Non-Significant Risk (NSR) Study will be used to assess the ability of CapsoCam® Plus (SV-3) capsule endoscope to detect the duodenal papilla and visualize pathology or abnormalities in the periampullary area and will prospectively compare the capsule endoscopy and EUS/ERCP pictorial images acquired in procedures conducted in a minimum of 20 and a maximum of 200 research patients.


Eligibility Criteria:
Inclusion Criteria:

* Males or females at least 18 years of age.
* Provided written HIPAA Informed Consent in the IRB approved language.
* Patients indicated for periampullary or pancreaticobiliary examination, with prior cross-sectional imaging (CT/MRI/US/other) performed within past 6 months.

Exclusion Criteria:

* Patients with existing biliary stent will be excluded
* EUS/ERCP exclusion criteria: per medical practice, including:

  1. Patient refusal to undergo procedure, unstable cardiopulmonary, neurologic, or cardiovascular status; existing bowel perforation
  2. Structural abnormalities of esophagus, stomach, small intestine at the discretion of physician.
* Capsule Endoscopy (CE) exclusion criteria:

  1. CE exclusion criteria: difficulty swallowing, pregnancy, known motility issues (gastroparesis), known strictures, gastrointestinal obstructions, fistula or significantly distorted anatomy.
  2. Medical history of receipt of surgery, oncologic therapy, or radiation therapy who, in the opinion of the investigator, are at greater risk of capsule endoscope retention.
  3. Any other contra-indicated condition as noted on the CapsoCam® Plus (SV-3) Instructions for Use, package insert.
Short Term Outcome of Primary Precutaneous Coronary Intervention in Ostial Versus Non Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infraction

To compare short-term clinical outcomes of primary PCI between the ostial LAD-AMI and the non-ostial LAD-AMI. The primary endpoint was the major cardiovascular events (MACE) defined as being the composite of cardiac death, AMI, stent thrombosis

Current guidelines recommend percutaneous coronary intervention (PCI) for most patients with ST segment elevation acute myocardial infarction (STEMI) or with non ST segment elevation acute coronary syndrome (NSTEACS) (1), (2). In STEMI patients, PCI is advised in all patients in the first 12 hours after onset of symptoms, the earlier the better (1).

Coronary revascularization does not always lead to coronary reperfusion. The development of devices and procedure has improved clinical outcomes of percutaneous coronary intervention (PCI) to the culprit of acute myocardial infarction (AMI) (3-5).

However, proximal left anterior descending artery (LAD)-AMI has still been associated with high morbidity and mortality because of the broad ischemic area (6, 7). In fact, clinical outcomes were significantly worse in the proximal LAD-AMI as compared with the mid LAD-AMI.5) Moreover, the proximal LAD disease in stable angina was closely associated with early revascularization following optimal medical therapy (8). Therefore, clinical guidelines regarding coronary revascularization have discriminated the proximal LAD disease from other LAD diseases (9).

In terms of coronary revascularization, the ostial LAD disease requires special attention in the proximal LAD disease, because percutaneous coronary interventions (PCI) can be more complex in the ostial LAD disease than in the non-ostial proximal LAD disease (10) even in the setting of AMI, left-main-trunk (LMT)-to-LAD crossover stenting was frequently required in the ostial LAD disease (11).

Eligibility Criteria:
Inclusion Criteria:

1. Patients who were diagnosed as Anterior STEMI according to criteria developed by the European Society of Cardiology.
2. Onset of maximal intensity of chest pain within 12 hours before procedure

Exclusion Criteria:

1. Patients presenting with Previous PCI to LAD.
2. Patients presenting with Previous CABG.
3. Patients presenting with NSTEMI ACS.
QBSAfe: A Novel Approach to Diabetes Management Focused on Quality of Life, Burden of Treatment, Social Integration and Avoidance of Future Events

The purpose of this study is to co-develop a toolkit (known as the QBSAfe toolkit) with patients, family caregivers, and clinicians that focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety for patients with diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

-Existing diagnosis of diabetes mellitus; have an existing appointment with a participating clinician

Exclusion Criteria:

* Do not speak English
* Severe vision/hearing impairment
* Unable to give informed consent for any reason
Ivermectin-Azithromycin-Cholecalciferol (IvAzCol) Combination Therapy for COVID-19

As the world faces COVID-19, the search for effective treatments against the disease and its complications has turned its gaze to drugs that are classically used in other infectious diseases. Some drugs are being examined for the recent evidence on its effects on viral replication and inflammation, one is Azithromycin, used to treat a wide variety of bacterial infections, Ivermectin, an anti-parasitic drug and the other is Cholecalciferol to increase serum concentration of 25-hydroxyvitamin D.

The aim of the study is to assess the efficacy of Ivermectin-Azithromycin-Cholecalciferol combination in COVID-19 in early stages of the disease with outpatient management.

Enrollment of subject into the trial shall only occur after providing written permission to voluntarily participate into the study by signing and dating the informed consent form before starting any trial related treatment. 30 cases of COVID-19 will be enrolled into the trial with a 3:1 proportion, divided into two groups. First group with confirmed cases of COVID-19 shall be treated with Ivermectin (6mg once daily in day 0,1,7 and 8) plus Azithromycin (500mg once daily for 4 days) plus Cholecalciferol (400 IU twice daily for 30 days) in an outpatient regimen. The second group with confirmed cases of COVID-19 who refused treatment were shall be allocated as the control group for monitoring.

Test for virus at day 1 and 14 from beginning of trial drug started for the outpatient regimen.

Clinical symptoms, oxygen saturation and oxygenation index will be monitored every day of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed infection of SARS-CoV2 virus
* Mild COVID-19
* Symptoms of respiratory illness
* Cough
* Fever (T \>38 °C)

Exclusion Criteria:

* Allergy to any of the drugs treatment
Optimizing the Management of Acute Diarrhoeal Disease

Many children admitted to hospital in Botswana without bloody diarrhoea are presumed to have viral gastroenteritis and so not treated with antibiotics - but they may indeed have a treatable cause for their illness. The investigators will conduct a randomized trial to see if rapid testing using novel methods to identify potentially treatable causes of diarrhoea leads to improved outcomes. The investigators will also be randomizing children to Lactobacillus reuteri DSM (daughter strain) 17938 therapy versus placebo (the standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a large multi-centre trial following the previous pilot trial.


Eligibility Criteria:
Inclusion Criteria:

* acute diarrhoeal illness (\>= 3 stools in 24 hour period)

Exclusion Criteria:

* diarrhoeal illness \>=14 days
* bloody stool
* known inflammatory bowel disease, cystic fibrosis, or malignancy
* live in a household with someone else documented to have a bacterial or parasitic enteric infection of defined aetiology
* live outside catchment areas
* no permanent address
* no access to mobile phone
* previous participation in this study
* nosocomial diarrhoea
Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor

Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance.

Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged ≥ 18 years
2. Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
3. Patients with histologically or cytologically squamous or non-squamous documented NSCLC, metastatic stage at study entry, not eligible for definite surgery or radiation, without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy; other sensitizing mutations known to be immunosensitive are eligible in case of lack of local access to targeted therapy (i.e.; KRAS G12C and BRAF mutations) after Sponsor's agreement
4. Patients with secondary resistance to ICI;

Other inclusion and exclusion criteria will apply per protocol.
ARFI Imaging for Targeted Prostate Biopsy

The purpose of this study is to evaluate a new ultrasound technique. This technique may provide additional and improved information about the stiffness and sizes of the internal structures of your prostate in order to improve the guidance for a targeted biopsy. The investigational, custom-designed probe and needle guide will be used to produce images of your prostate and provide guidance for up to 4 additional biopsy samples (cores) prior to a standard magnetic resonance (MR) ultrasound fusion biopsy procedure. Above the time required for the MR ultrasound fusion biopsy, this study will take up to 30 additional minutes of time for collection of the investigational device guided collection of biopsy samples Risks of participation include increased time under anesthesia (to collect additional biopsies) and slight heating of tissue.


Eligibility Criteria:
Inclusion Criteria:

* Men who are scheduled to undergo ultrasound fusion-MR prostate biopsy;
* Men who are willing to participate in the study;
* Subjects must freely sign informed consent to enroll in the study;
* Assessing eligibility: eligibility for the study will be assessed, based upon the above criteria, by the participating urologist at the time of consultation.
* 18 years or older

Exclusion Criteria:

* Men who have had previous treatment for PCa including radiation, cryoablation, chemotherapy, surgery, high intensity focused ultrasound (HIFU), laser therapy or hormone therapy;
* Men who have had previous non-pharmacological invasive or minimally invasive treatment for benign prostatic hypertrophy (BPH) (i.e., TURP, TUMPT, WIT, TUNA, etc);
* standard pharmacological treatment of BPH is allowable
* Men who are mentally impaired and cannot give written consent;
* Men with anomalies of the rectum.
20 Week Bridging Study in Type II DM

A multicenter, non-comparative, one arm, open, phase III study to evaluate the efficacy and safety of insulin glargine on subjects with Type 2 Diabetes Mellitus


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus diagnosed at least 3 years ago
* Treated concomitantly with insulin once a day and SU over at least 3 months prior to study entry
* Treated with OHA monotherapy over at least 1 year
* HbA1c greater than or equal to 7.5% and less than or equal to 12.0%, at visit 1 (screening visit)
* BMI \< 40 kg/m2
* No history of ketonemia
* Women of childbearing potential using the medically approved contraceptive method
* Ability and willingness to perform blood glucose monitoring using a blood glucose meter as per the requirement of protocol

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
IMMUNERECOV CONTRIBUTES TO IMPROVEMENT OF RESPIRATORY AND IMMUNOLOGICAL RESPONSE IN POST-COVID-19 PATIENTS.

Background: COVID-19 left consequences in different organs from months to years requiring different types of rehabilitation. In fact, a severe loss in the lung function, and in the respiratory and peripheral muscle strength is commonly observed in post-COVID-19 patients. Objectives: Thus, the present study investigated whether 30 days of supplementation with a nutritional blend (ImmuneRecov®; composition: whey protein concentrate, astaxanthin, creatine, selenium, vitamin C, glutamic acid, tryptophan, magnesium) would help to minimize the respiratory (lung function) and muscular (respiratory and peripheral muscles) sequelae in post-COVID-19 patients.

Background: COVID-19 left consequences in different organs from months to years requiring different types of rehabilitation. In fact, a severe loss in the lung function, and in the respiratory and peripheral muscle strength is commonly observed in post-COVID-19 patients. Objectives: Thus, the present study investigated whether 30 days of supplementation with a nutritional blend (ImmuneRecov®; composition: whey protein concentrate, astaxanthin, creatine, selenium, vitamin C, glutamic acid, tryptophan, magnesium) would help to minimize the respiratory (lung function) and muscular (respiratory and peripheral muscles) sequelae in post-COVID-19 patients. Design: This is a non-controlled open label prospective clinical study. Methods: Fifty-eight post-COVID-19 patients were recruited and twenty-four accepted to take the nutritional blend, while twenty-four did not accept but required to participate in the evaluations and 10 refused to participate. So, the patients were evaluated before the 14th day after hospital discharge and after 30 days of use of the nutritional blend or control (no supplementation).

Eligibility Criteria:
Inclusion Criteria: The inclusion criteria encompassed post-COVID-19 patients with a confirmed COVID-19 diagnosis through a positive RT-PCR test, who also required hospitalization, meeting the criteria for moderate severity classification as defined by the World Health Organization (WHO). In summary, according to the WHO, moderate illness is characterized by individuals who exhibit signs of lower respiratory disease during clinical assessment or imaging and maintain an oxygen saturation level (SpO2) of ≥94% while breathing room air at sea level.

Exclusion Criteria: Exclusion criteria included individuals discharged from the hospital for more than 14 days and those who initiated physical activity or began taking any dietary supplements or vitamins.
Eye Movements Recording Using a Mobile : Comparison to Standard Video-oculography in Young Athletes

This study aims to compare measurements obtained through the e-VOG application (mobile application, usable on smartphones or tablets, to measure eye movements) with measurements from the standard video-oculography device (Eye-Tracker®T2), in young athletes.

e-VOG Young athletes is a collaborative study between the Memory Center of the Rainier III Center (Princess Grace Hospital, Monaco), the Neurology Department of Nice University Hospital (France), and the AS Monaco Football Academy medical team.

Memory Center of the Rainier III Center is expert in eye-tracking and is equipped with a standard video-oculography device (Eye-Tracker®T2), which records eye movements at a high frequency and measures saccades parameters (latency, speed, amplitudes etc...).

e-VOG is a mobile application, home-developed by the Neurology Department team of Nice University Hospital, to measure eye movements.

Based on literature, investigators hypothesize that video-oculography could integrate assessment protocols for head trauma occurring during sports practice. The nomadic nature of the e-VOG application would make possible to assess oculomotor behaviors to a subject who has just suffered a trauma and who is suspected of having a concussion.

From this perspective, it seems necessary to firstly validate baseline values of the e-VOG application in a population of athletes without major health problems, and who have not presented concussion.

Eligibility Criteria:
Inclusion Criteria:

* Young Athletes from AS Monaco Football Academy
* referred by AS Monaco Medical Team to perform a video-oculography (Eye-Tracking) examination as part of routine care.
* covered by a health insurance system
* volunteer, able to give free, informed and written consent.
* For minors: whose holder of parental authority has given their written consent to participate following the information given by investigator.

Exclusion Criteria:

* General anaesthesia within 3 months.
* Head trauma within 3 months
* Neurological, ophthalmological or general pathology preventing the realization of a video-oculography examination.
* Oculomotor abnormality detectable on clinical examination by the neurologist prescribing the standard video-oculography examination.
An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy

The primary objective of the trial is to assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Subject has successfully completed a previous trial with SPM 927 in diabetic neuropathy and, in the investigator's opinion, would benefit from long-term administration of SPM 927.
* Subject has stable, good or fair diabetic control (HbA1c ≤10% ).

Exclusion Criteria:

* Subject has other conditions that cause neuropathic pain at least as severe as the diabetic pain, i.e. peripheral arterio-vascular disease.
* Subject receives treatment for seizures.
* Subject has had an amputation related to diabetes, other than toe amputation.
* Subject has major skin ulcers.
* Subject has clinically significant ECG abnormalities.
* Subject expects to take during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, skeletal muscle relaxants, benzodiazepines or over-the-counter medications with centrally acting properties.
* Subject has laboratory values which are outside the normal range and judged by the investigator to be clinically significant.
* Subject has liver function tests (AST, ALT, alkaline phosphatase, total bilirubin, or GGT) ≥ 2x ULN at Visit 1.
* At Visit 1, subject has impaired renal function, i.e., creatinine clearance (ClCr) is lower than 60 mL/min.