cyrilzakka/clinical-trials huggingface dataset:
A Study of Multiple Doses of Lasmiditan in Healthy Participants

The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood stream and how long it takes the body to get rid of it.

When drugs are taken together, one or all of the drugs used in combination may be affected. This study will also evaluate the concentrations in the blood of a probe drug cocktail taken alone and in combination with lasmiditan. Information about any side effects that may occur will also be collected.

The study has two parts. Participants will only enroll in one part. This study will last about 25 days for group 1 and 22 days for group 2, not including screening. Screening is required within 28 days prior to the start of the study.

This study is for research purposes only and is not intended to treat any medical condition.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females, as determined by medical history and physical examination
* Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening

Exclusion Criteria:

* Have participated, within the last 30 days, in a clinical study involving an Investigational Product (IP)
* Have previously completed or withdrawn from this study or any other study investigating Lasmiditan, and have previously received Lasmiditan
* Have clinically significant abnormality in the 12-lead ECG, including corrected QT interval (QTc) with Fridericia's correction (QTcF) greater than (\>) 450 milliseconds (ms) for men or \>470 ms for women or any abnormality that in the opinion of the investigator increases the risk of participating in the study (not limited to significant bradycardia or heart block)
* History of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression), have a recent history of a suicide attempt (30 days within screening visit and any time between screening visit and baseline); or are clinically judged by the investigator to be at risk for suicide
* History of hypoglycemia
* Known history of glucose-6-phosphate dehydrogenase deficiency
* Are taking a concomitant medication or a dietary substance that affects cytochrome P450 (CYP)1A2, CYP2C9, and/or CYP3A isotypes within 14 days of screening
PCV13 Effectiveness Study Against Hospitalised VT Pneumococcal CAP in Adults 60 Years and Older

Low interventional, prospective, multicentre, hospital-based study involving adults 60 years of age and older hospitalised with CAP at participating sites.

PCV13 efficacy for the prevention of vaccine-type community-acquired pneumonia (VT-CAP) and invasive pneumococcal disease (IPD) was established in the Community-acquired Pneumonia Immunization Trial in Adults (CAPITA) aged 65 and older. However, there are still few available real-life effectiveness estimates in adults. The aim of this study is to evaluate the PCV13 vaccine effectiveness (VE) against hospitalised VT-pneumococcal CAP among adults aged ≥60 years in the Region of Madrid (Spain). Determination of the effectiveness of PCV13 to prevent hospitalised vaccine-type (VT)-pneumococcal CAP among adults aged ≥60 years in Madrid will be evaluated using a test-negative design study, overall and among immunocompetent persons only.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥60 years.
2. Evidence of pneumonia within first 48 hours of hospital admission
3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

1. Any patient who develops signs and symptoms of pneumonia after being hospitalized for ≥48 hours (either at current hospital, another transferring hospital, or a combination of these).
2. Previously enrolled subjects readmitted ≤14 days after discharge for their study qualifying admission.
3. At the time of enrollment, pneumonia has been excluded as the diagnosis or another diagnosis confirmed.
Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization

Purpose: To determine the efficacy and safety of one commonly used VEGF inhibitor, bevacizumab (Avastin, Genentech), as a topical agent for the treatment of corneal neovascularization.


Eligibility Criteria:
Inclusion Criteria:

* male or female, at least 18 years of age
* clinically stable corneal neovascularization
* superficial or deep corneal neovascularization that extends farther than 2mm from the limbus
* ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits.

Clinical stability - all of the following criterial should be excluded before a corneal neovascularization can be regarded as clinically stable:

* current or recent (\<3 months) episode of corneal and ocular surface infection (bacterial, viral, fungal, or acanthamoebal)
* recent (\<3 months) ocular surgery, including cataract surgery, and/or laser of any type in the study eye
* recent (\<6 months) full thickness or lamellar keratoplasty
* recent (\<6 months) ocular surface reconstruction, limbal auto or allograft stem cell transplantation, or amniotic membrane transplantation
* current or recent (\<3 months) use of contact lens or plan to use contact lens (excluding bandage contact lens)
* current or recent (\<3 months) persistent corneal epithelial defect (of at leat 14 days duration) measuring more than 1mm2

Exclusion Criteria:

* current or recent (\<1 month) systemic corticosteroid therapy or periocular corticosteroid injections to the study eye
* current or recent (\<3 months) intravitreal durg injection to the study eye.
* recent (\<1 month) change in dose and frequency of topical steroids and/or non-steroidal anti-inflammatory agents
* uncontrolled hypertension defined as systolic blood pressure \>150 mmHg or diastolic blood pressure of \>90 mmHg
* history of a thromboembolic event, including myocardial infarction or cerebral vascular accident
* patients age 75 or older
* history of renal abnormalities
* recent (\<3 months) or planned surgery
* history of coagulation abnormalities, including end stage liver disease or current anticoagulation medication other than aspirin (warfarin, heparin, enoxaparin or similar anticoagulant agent)
* all female patients of childbearing potential will be excluded. A female is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries.
* any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
* any condition that precludes the patient's ability or an assisting family member's ability to apply the medication drops or to sustain five minutes of pressure on the lacrimal ducts after drop application.
* concurrent enrollment in another clinical investigation medicinal product or device study is prohibited.
Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease

Chronic inflammatory rheumatic diseases (CIRD) affect many organ systems. Painful sensations within the joints spine, hand and foot deformities, low quality of life and psychosocial status in patients with rheumatoid arthritis, spondyloarthritis and psoriatic arthritis can lead to the development of anxiety and depression. Prevalences of anxiety increase in patients suffering of CIRD, compared with healthy individuals. Another connection has been identified by the links between depression and systemic inflammation. It is proven that higher plasma levels of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNFa) affect neurotransmitter metabolism, with influence on patients mood. The purpose of EMOTION study is therefore to analyze thymic variation under TNFa therapy, as treatment of CIRDs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 ; ≤ 80)
* Patient with rheumatoid arthritis (RA) according to the ACR 2010 criteria, axial or peripheral spondyloarthritis (SpA) according to ASAS criteria, ankylosing spondylitis (AS) according to the New York criteria or psoriatic arthritis (PsA) according to CASPAR criteria
* Signature of informed consent
* Affiliation to a French social security or receiving such a scheme

Exclusion Criteria:

* Patient having previously received anti-TNFα treatment
* Patient with previously diagnosed depressive or psychiatric pathology and / or receiving anti-depressant treatment
* Subjects with limited legal capacity.
* Subjects judged by the investigator to be unlikely to comply with study procedures
* Subjects with no social security coverage.
* Pregnant women.
* Subjects still in the exclusion period of another study, or according to the national registry of clinical trial participants.
Patients' Perspectives About a Pain Education Video

The overall goal of this single session semi-structured interview project is to explore the validation and contradiction of the preexisting pain beliefs in patients with chronic pain.

Aim 1: After patients watch an educational video, explore occurrences of perceived validation and contradiction and the impact of validation and contradiction on pain beliefs, emotion, and pain.

Aim 2: Obtain patients' recommendations for improving the educational value of the video.

The long-term goal is to reduce disability in patients with chronic pain by improving communication about pain among patients, caregivers, and health care providers (HCPs). The proposed study addresses the long-term goal by conducting a project that investigates the validation and contradiction of patients' preexisting pain beliefs during pain education. Completion of the proposed project will advance the literature on validation and contradiction in patients with chronic pain by (1) focusing on a pain education resource instead of dyadic communication, (2) modifying a measure of validation and contradiction for relevance to an education resource, (3) exploring erroneous perceptions of validation and contradiction, (4) examining the impact of validation and contradiction on pain beliefs, and (5) obtaining patients' recommendations for a popular pain education film. The information gained will be used to improve pain education resources to increase their beneficial effects on pain and disability.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older;
* new patient of the CPMC;
* living independently; and
* self-reported recurrent or persistent pain on most days of the last year.

Exclusion Criteria:

* previously viewed the pain education video used in this project;
* insufficient hearing to communicate with an interviewer; and
* an inability to complete the session within the time allowable.
To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JC-001 and JLP-1901

To evaluate the safety and pharmacokinetic characteristics after the administration of JC-001 and JLP-1901

An open-label, randomized, single administration, full replicated crossover phase 1 clinical trial to compare pharmacokinetics and safety between JLP-1901 and JC-001 in healthy subjects

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults over 19 years of age and under 65 years of age at the time of screening test
2. Those with a body mass index (BMI) of 17.5 kg/m2 or more but less than 30.5 kg/m2 and a body weight of 55 kg or more for men and 45 kg or more for women.
3. Those who do not have congenital or chronic diseases within the past 3 years and have no pathological symptoms or findings as a result of internal medical examination
4. Subjects determined to be suitable as a trial subject as a result of tests performed during screening, such as laboratory tests (hematology test, blood chemistry test, urinalysis, virus/bacteria test, etc.) conducted by the investigator according to the characteristics of the drug, vital signs, and electrocardiogram test.

Exclusion Criteria:

1. Those who have history or evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, nervous or immune diseases (excluding simple dental history such as calculus, impacted teeth, wisdom teeth, etc.)
2. Those whd have a history of gastrointestinal disease (esophageal disease such as achalasia or esophageal stricture, Crohn's disease) or surgery (excluding simple appendectomy, hernia surgery, or tooth extraction surgery) that may affect drug absorption ruler
3. A subject who shows the following values as a result of a laboratory test:

   ☞ ALT or AST \> 2 times the upper limit of normal range
4. Those with a history of regular alcohol consumption exceeding 210 g/week within 6 months of screening (1 glass (250 mL) of beer (5%) = 10 g, 1 glass (50 mL) of soju (20%) = 8 g , 1 glass of wine (12%) (125 mL) = 12 g)
The Influence of Artificial Intelligence (AI )Assisted Polyp Detection (Discovery System) on Visual Gaze Patterns During Real-time Colonoscopy

In this study, the investigators aim to assess the influence of a computer-aided detection (CADe) system on the visual gaze patterns of endoscopists in order to further understand the effect of AI during real-time colonoscopy.


Eligibility Criteria:
Inclusion Criteria of patients:

* Referred for diagnostic, screening or surveillance colonoscopy

Exclusion Criteria of patients:

* Therapeutic procedure
* Boston Bowel Prep Score (BBPS) score of \<6
Diabetes and Partnership: Evaluation of a Diabetes Education Module

This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly developed treatment and education module will be tested compared to a waiting-list control group. The module covers the topic "diabetes and partnership". Primary outcome variable is diabetes-specific empowerment regarding diabetes and partnership. Secondary outcome variables are: diabetes-related distress, health-related quality of life, depressive symptoms, self-care behavior, and glycemic control.

The module consists of one lesson (duration: 90 minutes). The module is derived from the empowerment approach and is based on the previously evaluated education and treatment program for type 1 diabetes: PRIMAS (NCT01220557). The module is designed as a group session held by a trained diabetes educator. Patients are randomized either to the immediate participation in the module or to the control group. Control group is a waiting-list control group. Patients in this waiting-list control group get the education after the completion of the 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Intensive insulin treatment
* specific interest in "Diabetes and Partnership"
* wish to participate in group education
* informed consent
* fluent in reading and speaking German language

Exclusion Criteria:

* diabetes duration \< 4 week
* severe organic disease (e.g. terminal renal disease, cancer with poor prognosis)
* current treatment of a mental disease
* cognitive impairment
* dementia
* pregnancy
Dutch Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA). PET Sub Study

At one site, patients participating in the Corona main study are asked to participate in the PET-substudy. Before and 6 months after study medication is started a Positron Emission Tomography (PET-scan) is performed to study the effect of rosuvastatin in Chronic Heart Failure on myocardial perfusion (reserve)


Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling the in and exclusion criteria of the CORONA study and separate informed consent for participation in the sub study.

Exclusion Criteria:

* See above
A Clinical Study to Assess the Efficacy of Cannabigerol in Patients with Active Rheumatoid Arthritis.

This is a single-group exploratory longitudinal prospective study lasting 8 weeks. The study aims to measure the efficacy of purified cannabigerol (CBG) in patients with active rheumatoid arthritis using laboratory and self-reported outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, over 25 years of age
* Positive anti-CCP blood test
* Active RA-related inflammation with at least 2 swollen joints
* University graduate
* Generally healthy with no uncontrolled chronic disease
* Able to read, understand, and sign informed consent
* Resides in the USA
* Willing to comply with study requirements and avoid other cannabis products during the study period

Exclusion Criteria:

* Pre-existing chronic conditions preventing adherence
* Severe allergic reactions requiring an Epi-pen
* Use of opiates in the last 4 weeks or cannabis in the last 8 weeks
* Pregnant or breastfeeding women
* Recent invasive medical procedure or surgery
* Active malignancy or ongoing oncology treatment
* Use of cytochrome P450 or 3A4 inhibitors
* History of substance abuse
Postural Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 Infection

The purpose of this study is to evaluate if a postural recruitment maneuver (PRM) improves the aeration and distribution of lung ventilation in patients with Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19 infection; without the need to reach high airway pressures as in the standard lung recruitment maneuver and / or place the patient in prone position. This strategy could be particularly useful in the context of a major health emergency in centers with limited resources.

The PRM is based on the known effect of gravity on transpulmonary pressure (PL). Two principles explain its mechanism of action: 1) the first indicates that atelectasis and poorly ventilated areas of the lung can improve their aeration by putting the lung in the highest position. Opposite lateral decubitus causes that upper lung to have a higher PL and allow a recruiting effect at moderate airway pressures. 2) The second principle is based on Laplace's Law and postulates that once the upper lung is recruited, it remains without lung collapse if a sufficient level of positive end-expiratory pressure (PEEP) is applied. Based on these two precepts, PRM consists of sequentially moving the patient from the supine to the left lateral decubitus to recover the aeration of the right lung. After that, the patient is placed in the right lateral position to recruit the left lung; keeping the right lung without collapse by continuous use of PEEP. Finally, the patient returns to the supine position looking for an improvement in the distribution of ventilation and global pulmonary aeration, with a subsequent improvement in gas exchange and pulmonary mechanics.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age
* Patients with moderate-to-severe ARDS as per the Berlin definition
* Infection due to COVID-19
* Body mass index (BMI) ≤ 35 kg /m\^2.

Exclusion Criteria:

* Contraindication for EIT monitoring

  1. Unstable spine or pelvic fractures
  2. Pacemaker, automatic implantable cardioverter defibrillator
  3. Skin lesions between the 4th and 5th ribs where the EIT belt is worn
* Pregnancy
* Major hemodynamic instability::

  1. Mean arterial pressure lower than 60 mm Hg despite adequate fluid resuscitation and use of vasopressors.
  2. FC\> 120 or \<60 per minute
  3. Presence of uncontrolled arrhythmias.
* More than 1 week of mechanical ventilation
* Failure of more than 2 extrapulmonary organs.
Alcohol, Inflammation and Atherosclerosis

Effect of moderate alcohol consumption in form of red wine, beer and ethanol solution and corresponding de-alcoholised beverages on immune measures.

* In healthy middle aged men and women
* In a randomized controlled cross-over trial
* Two intervention periods over 3 weeks

Alcohol consumption and mortality from all causes are associated in a U-shaped manner. That means that individuals who regularly consume moderate amounts of alcohol (\~1 to 2 drinks/day at maximum) on average live longer than abstainers or heavy drinkers. This is primarily through a reduced risk for fatal or non-fatal coronary heart disease events (CHD) such as myocardial infarction. In the last 10 to 15 years compelling evidence has bolstered the hypothesis that atherosclerosis is at least in part an inflammatory disease. It is also known, that alcohol influences the immune system. These facts make an impact of alcohol on the various stages of atherosclerosis via anti-inflammatory effects a reasonable assumption.

To test the effect of moderate amounts of different types of alcoholic beverages on markers of inflammation with high predictive potential for atherothrombotic complications of atherosclerosis will be examined in a cross-over short-term interventional trial. Six groups, each comprising 12 healthy individuals aged 22-56 will be included. After two weeks of abstinence from alcoholic beverages two cross-over interventional phases (each lasting 3 weeks) with red wine, beer, de-alcoholised red wine and beer of the same brand, ethanol, or water will follow. The interventions will be followed by a wash-out period of 2 weeks. Several inflammatory markers and in-vitro migration of freshly isolated monocytes will be determined before and after intervention.

Eligibility Criteria:
Inclusion Criteria:

* 20-60 years
* non-smoker
* healthy

Exclusion Criteria:

* personal or family history of dependency
* any chronic disease
* acute and chronic inflammatory processes
Sensitivity of Multiparametric MRI in Differentiation Between Muscle Invasive and Non-muscle Invasive Urinary Bladder Cancer

Differentiation between non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) is a cornerstone in the treatment plans.Therefore, this study will try to evaluate the sensitivity and reliability of mpMRI in accurate diagnosis of cancer bladder.

Primary objective: to detect the sensitivity of multiparametric MRI in differentiation between muscle Invasive and non-muscle invasive Urinary Bladder Cancer in relation to the conventional cystoscopy and histopathological examination of the biopsy.


Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with NMIBC or MIBC during diagnostic cystoscopy or by any radiologic investigation in the Urology department of Helwan university hospitals without being restricted to age or sex.
* All histological types of bladder cancer
* Newly diagnosed, recurrent cases, or even patients undergoing follow-up cystoscopy.

Exclusion Criteria:

* Patients with elevated renal function according to their age as this will be a contraindication to DCE MRI.
* Patients with absolute contraindication to MRI (e.g.: metallic prosthesis).
* Patients with contraindication to undergo TURBT (e.g.: unfit for surgery).