cyrilzakka/clinical-trials huggingface dataset:
Rapid Agitation Control With Ketamine in the Emergency Department

Compare intramuscular (IM) ketamine to a combination of IM midazolam and haloperidol with regards to the time required for adequate behavioral control, in minutes, in patients presenting to the emergency department with psychomotor agitation and violent behavior.


Eligibility Criteria:
Inclusion Criteria:

1. Age 19 - 60 years inclusively;
2. Patients presenting to the emergency department with psychomotor agitation or violent behaviour (RASS score \> +3).

Exclusion Criteria:

1. Less than 19 years of age;
2. Greater than 60 years of age;
3. Previous participation in this study;
4. Women suspected or known to be pregnant or breastfeeding;
5. Previous known hypersensitivity, intolerance or allergy to ketamine, midazolam or haloperidol or their components.
6. Subjects who are in comatose states or have CNS depression due to alcohol or are taking other depressant drugs.
7. Subjects with severe depressive states, spastic diseases and in Parkinson's syndrome, except in the case of dyskinesias due to levodopa treatment.
8. Senile patients with pre-existing Parkinson-like symptoms.
9. Subjects with a history of cerebrovascular accident
10. Subjects in whom a significant elevation of blood pressure would constitute a serious hazard, such as patients with significant hypertension
11. Subjects with severe cardiac decompensation
12. Subjects who intend to have surgery of the pharynx, larynx, or bronchial tree unless adequate muscle relaxants are used
13. Subjects with acute pulmonary insufficiency
14. Subjects with severe chronic obstructive pulmonary disease
15. Subjects with acute narrow angle glaucoma
Epidemiology Study of Keloid

Although keloid is a very common condition; there are no statistics as to its true incidence and prevalence, neither in United States, nor elsewhere in the world. This trial intends to capture epidemiological data about this disease in a large population sample.

The purpose of current trial is to establish a robust database of incidence and prevalence of keloid, as well as prevalence of familial keloid, in various ethnic groups. Study sample size is 100,000 random individuals who will fill out either a web survery or a paper questionnaire.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent
2. Age above 18 to answer the survey questions
3. Parents shall respond on behalf of their minor children

Exclusion Criteria:

* None
The Effect of SAAE on Vascular Endothelial Function in PA Patients

The study aims to assess the effect of superselective adrenal arterial embolization on vascular endothelial function in patients with primary aldosteronism based on brachial artery flow-mediated relaxation

After being informed about the study and potential risks,all patients giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry.At week 0,patients who meet the eligibility requirements will be divided into Superselective adrenal arterial embolization group or spironolactone therapy group,according to the patient's surgical indications and wishes.

Eligibility Criteria:
Inclusion Criteria:

* (1)Aged 18-75 years, males and females;
* (2)Blood pressure ≥ 140/90 mmHg on at least three non-same-day office visits without antihypertensive medication or 24-hour ambulatory blood pressure averaging \>130/80 mmHg throughout the day or averaging \>135/85 mmHg during the day;
* (3)Primary aldosteronism was diagnosed in accordance with the 2016 international society of Endocrinology clinical guidelines after strict drug elution;
* (4)Contraindications to spironolactone-free administration;
* (5)No surgical intention or surgical contraindications, and willing to accept drug treatment or percutaneous superselective adrenal artery embolization;
* (6)The anatomy of adrenal arteriography is suitable for selective adrenal artery embolization.

Exclusion Criteria:

* (1)Secondary hypertension of other causes;
* (2)Pregnant women or those who have a fertility plan in the next year;
* (3)Glomerular filtration rate EGFR \< 45 ml/min/1.73m\^2;
* (4)History of severe contrast allergy;
* (5)Hyperkalemia;
* (6)Patients with other serious organic diseases or life expectancy \< 12 months can not tolerate the treatment of super selective adrenal artery embolizatio;
* (7)The diameter of adrenal space occupying lesions was more than 2 cm;
* (8)A history of myocardial infarction, syncope, cerebral hemorrhage or cerebral infarction within 3 months before the informed consent;
* (9)The results of this study will be affected during the period when patients are enrolled or will participate in other clinical studies.
Effect of Nutritional Intervention on Metabolic Response in Infants

The purpose of this study is to determine the glucose response of complementary feeding regimens consisting of two different follow-up formulas (FUFs) and infant cereals (ICs).

This is a prospective, randomized, single-blind, controlled, 2-arm parallel group trial in infants aged 6 months (26 weeks) at enrollment, who are no longer breastfed, and who are ready but have not yet started complementary feeding. They will be fed one of two different isocaloric feeding regimens (Experimental \[EXPL\] or Control \[CTRL\]) consisting of different follow-up formulas (FUFs) and infant cereals (ICs). The main purpose of this study is to determine the glucose response of these two different complementary feeding regimens. All enrolled infants will participate in the trial for approximately 6 months.

Eligibility Criteria:
Inclusion Criteria:.

1. Written informed consent has been obtained from both parent / liable parent or legally acceptable representative (LAR), if applicable
2. Healthy infant who was singleton, full-term gestational birth (≥ 37 completed weeks of gestation) with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg
3. Infant is no longer breastfeeding or receiving breast milk, has not yet started FUF, and is developmentally ready to begin complementary feeding
4. Infant's parent(s)/guardian is of legal age of consent, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol.
5. At screening visit (visit 0), infant is 24 - 26 weeks (5½ - 6 months) old
6. Weight-for-height value \>-2 standard deviations from the WHO Child Growth Standards median

Exclusion Criteria:

1. Chronic infectious, metabolic, or other disease including any condition that in the opinion of the investigator may impact feeding, growth or adherence to study procedures
2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
3. Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, gluten sensitivity or severe food allergies that impact diet
4. Born to mothers with gestational diabetes or type 1 diabetes
5. Major medical/surgical event requiring prolonged hospitalization during the first 6 months
6. Receiving or having received insulin, growth hormone or any other medication known to affect glucose or carbohydrate metabolism or pre- or probiotics known to affect fecal microbiota prior to enrollment
7. Subjects or subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol
8. Currently participating or having participated in another clinical trial within 4 weeks prior to trial start
Dyspnea in Stable Patients With Coronary Artery Disease.

Single-centre prospective study to characterize causes of dyspnea in stable patients with coronary artery disease and evaluate the possibility to determine the cause of dyspnea before in-depth examination.

Stable patients with dyspnea and coronary artery disease will be included in this single-centre prospective study. In addition to routine clinical examination patients will be interviewed to determine the nature of shortness of breath, angina, presence of chronic heart failure or anxiety using the Medical Research Council Dyspnea scale, the visual analog scale of dyspnea, Borg scale, modified "dictionary" of dyspnea, G. Rose questionnaire, Seattle Angina Questionnaire, Framingham criteria for chronic heart failure and the SHOCK scale. During the subsequent in-depth examination including thyroid hormones, NT-proBNP, hsTroponin, ECG monitoring, six-minute walk test, stress-echo with a diastolic stress test, spirometry and coronary angiography (if necessary) main reason for dyspnea will be established. Possibilities of early (before in-depth examination) determination the reason for dyspnea in stable patients with coronary artery disease will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Stable patients with shortness of breath and established diagnosis of coronary artery disease (at least 1 of the following signs):

   * history of myocardial infarction;
   * typical angina without suspected other cause of pain;
   * myocardial ischemia documented by ECG changes during symptoms and/or by results of the stress test;
   * coronary artery stenosis \>50% according to coronary angiography.
2. Signed informed consent.

Exclusion Criteria:

1. Acute coronary syndrome (myocardial infarction, unstable angina) in the previous month.
2. Hospitalization with decompensation of CHF in the previous 6 months (including CHF decompensation as the main reason for current hospitalization).
3. Diseases with an unfavourable prognosis (terminal CKD, CHF NYHA IV, a lung disease with severe respiratory failure).
4. Contraindications to bicycle stress echocardiography.
5. Atrial Fibrillation at the time of hospitalization, when the decision not to restore the sinus rhythm.
6. Mental illnesses and disorders, dementia, drug or alcohol dependence.
7. Known oncological diseases.
Online Wellness Intervention in Medical Students

Medical students are at high risk of stress. This project will test how well a 12-week stress reduction program works to reduce stress, anxiety and depression and improve well-being. The program is delivered online and each week is made of an introduction video, 7-8 minutes of yoga, 5-7 minutes of meditation and nutrition tips. At the beginning and the end of the 12-week research study, we will be using surveys to ask students about their stress, anxiety, depression, sense of control over their own life, quality of life, and pain levels. After the program, the research team will conduct interviews with the medical student to allow them to share their other feedback about the program. The researchers will also send surveys to the medical students one month after the program ends to asses their continued satisfaction with and adherence to the program.


Eligibility Criteria:
Inclusion Criteria:

- Medical students in any year of medical school

Exclusion Criteria:

* Hospital Anxiety and Depression Scale (HADS) Depression score \>10
* Active psychosis
* Post-traumatic stress disorder or frequent suicidal ideation
* Major medical co-morbidity
* Inability to provide written informed consent
A Study for Participants Previously Treated With Century Therapeutics Cellular Therapy Product

This study is designed to collect long-term safety and survival data from participants previously treated in an eligible Century-sponsored index trial. This is an observational study, and the elements of the study design allow for important follow-up for safety, survival, and the continued evaluation of any late adverse events (AEs) that may appear after treatment with such cellular products. Additionally, collection of persistence data from participants will support the identification of any long-term risks or late AEs that may be causally related to treatment with such cellular products.


Eligibility Criteria:
Inclusion Criteria:

* Participant has provided written informed consent prior to any long-term follow-up (LTFU) study-specific procedures.
* Participants received at least one treatment with a cellular therapy product in an eligible index trial.
* Participant was withdrawn, early discontinued or completed an eligible index trial.
* Participant is willing and able to comply with scheduled visits, study plan, and other study procedures.

Exclusion Criteria:

-This study has no exclusion criteria.
Effect of the TEGO Connector in Preventing Tunneled Cuffed Hemodialysis Catheters From Dysfunction and/or Bacteremia

The aim of the trial was to assess whether use of the TEGO connector was able to reduce the incidence of a composite endpoint of TCC-related dysfunction (TCC-D)or TCC-related bacteremia (TCC-B) in chronic hemodialysis (HD) patients carrying the TEGO® connector vs controls receiving trisodium citrate 46.7%.

The TEGO® connector (ICU Medical, www.icumed.com) is a closed positive pressure system, flushed with 0.9% sodium chloride and attached on the hubs of the TCC. As recommended by the producer, the TEGO® remains during 3 consecutive HD sessions and is changed every week. By constituting a mechanical barrier, it could be an interesting alternative to reduce the intraluminal contamination and the risk of TCC-B.

The TEGO® connector is supposed to provide an automatic positive displacement of fluid at the end of each TCC flush. This positive pressure could prevent the reflux of blood into the TCC lumen, possibly resulting in TCC-D.

As the impact of the TEGO® connector on TCC-D and TCC-B has never been studied, we conducted a randomized controlled study in our center by comparing the anti-thrombotic and anti-infectious efficacy of the TEGO® connector to trisodium citrate 46.7% (Citralock®, Dirinco, www.citra-lock.com) . The global cost of both procedures was also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Adult HD patients, prevalent or incident,carrying a tunneled cuffed catheter
* Tunneled cuffed catheter providing a mean blood flow superior to 250 ml/min
* Patients having signed an informed consent

Exclusion Criteria:

* Mature arterio-venous fistula
* Episode of TCC-related bacteremia 1 week before randomization
Glycaemic Response and Insulinaemic Response for Nutralys S85 Plus and Whey Protein

A comparison of the glycaemic response and insulinaemic response to glucose, Nutralys S85 Plus pea protein and whey protein using a single-blind, randomised, repeat measure, crossover design trial.

A single-blind, randomised, repeat measure, crossover design trial will be used to study the glycaemic response and insulinaemic response following consumption of five products: one reference product (50 g available carbohydrate Glucose) and four test products (50 g available carbohydrate Glucose with 10 g NUTRALYS®S85 Plus pea protein, 50 g available carbohydrate Glucose with 20 g NUTRALYS®S85 Plus pea protein, 50 g available carbohydrate Glucose with 10 g Whey protein concentrate and 50 g available carbohydrate Glucose with 20 g Whey protein concentrate).

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 60 years
* Body mass index (BMI) less than 30kg/m2

Exclusion Criteria:

* Pregnant or lactating
* Fasting blood glucose value \> 6.1 mmol/l
* Any known food allergy or intolerance
* Medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or which influence digestion and absorption of nutrients
* Known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions
* Major medical or surgical event requiring hospitalization within the preceding 3 months
* Use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution)
* Unable to comply with experimental procedures or did not follow GR testing safety guidelines.
Epidural Waveform Analysis for Thoracic Epidural Blocks

Epidural waveform analysis (EWA) provides a simple confirmatory adjunct for loss-of-resistance (LOR): when the needle/catheter tip is correctly positioned inside the epidural space, pressure measurement results in a pulsatile waveform. Epidural waveform analysis can be carried out through the tip of the needle or the catheter. In this randomized trial, the objective is to compare epidural waveform analysis through the needle (EWA-N) and through the catheter (EWA-C) for thoracic epidural blocks.

The epidural space is most commonly identified with loss-of-resistance (LOR). Though sensitive Epidural waveform analysis (EWA) provides a simple confirmatory adjunct for LOR. When the needle (or catheter) is correctly positioned inside the epidural space, pressure measurement at its tip results in a pulsatile waveform synchronized with arterial pulsations Currently, there exist two different methods for EWA. Since local anesthetic (LA) is administered through the catheter, pressure transduction through its tip ensures that it is properly positioned inside the epidural space prior to LA injection. Alternately, EWA can be performed through the needle prior to blind advancement of the epidural catheter.

Thus, in this randomized trial, the aim is to compare epidural waveform analysis through the needle (EWA-N) and through the catheter (EWA-C) for thoracic epidural blocks. The hypothesis is that, compared to EWA-C, EWA-N will result in a shorter performance time.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years
* American Society of Anesthesiologists classification 1-3
* body mass index between 20 and 35

Exclusion Criteria:

* adults who are unable to give their own consent
* coagulopathy
* renal failure
* hepatic failure
* allergy to local anesthetic
* pregnancy
* prior surgery in the thoracic spine
A Retrospective Observational Study on the Long-term Effects of Ipilimumab-treated Pediatric Participants in the Dutch Melanoma Treatment Registry (DMTR)

This is an observational, national, retrospective study consisting of pediatric patients with advanced (spread or unremoveable) melanoma identified in the DMTR in the Netherlands


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trials, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Less than 18 years of age at first dose of monotherapy Ipilimumab used for treatment of advanced melanoma
* Histological or cytological confirmation of advanced (unresectable or metastatic) melanoma

Exclusion Criteria:

-Participation in a clinical trial within the past 4 weeks prior to first dose with ipilimumab or concurrently

Other inclusion/exclusion criteria apply
Determining Predictors of Restenosis in Femoropopliteal Lesions

A prospective, single-center, real-world study on intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.

Intravascular ultrasound is considered important tool in endovascular procedures of coronary territory. Information such as vessel diameter, stent expansion, residual stenosis, helped in better understanding of the disease, treatment and stent behavior.

However, as a different anatomical territory with major hemodynamic differences, many of these concepts could not be reproduced in the femoropopliteal segment.

The purpose of this study is to correlate data collected by intraoperative intravascular ultrasound after the angioplasty procedure with stent placement in femoropopliteal arterial lesions and patency of this revascularization within 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Stenotic (\>50%) or occlusive atherosclerotic disease of the femoropopliteal arteries;
* Successful lesion passage passed with conventional mechanical guidewires;
* Symptomatic critical limb ischemia (Rutherford 4, 5, 6);
* Life-expectancy of more than 12 months;
* Tha patient must be willing and able to return to the appropriate follow-up times for the duration of the study;
* Te patient must provide written patient informed consent that is approved by the ethics committee.

Exclusion Criteria:

* Patient refusing treatment;
* The reference segment diameter is not suitable fo available balloon and/or stent design;
* Unsuccessfully treated (\>30% residual stenosis) proximal inflow limiting arterial stenosis;
* Previously implanted stent(s) or percutaneous transluminal angioplasty at the same lesion site;
* The patient has a known allergy to heparin, Aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies;
* The patent has a history of prior life-threatening contrast media reaction;
* The patient is currently enrolled in another investigational device or drug trial;
* The patient is currently breast-feeding, pregnant or intends to become pregnant;
* The patient is mentally ill or retarded.
Long-term Safety and Tolerability of AFFITOPE AD02

The purpose of this study is to evaluate the long-term tolerability and -safety of AFFITOPE AD02 applied during AFFiRiS 002


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed and dated by patient and caregiver
* Patients having participated in AFF002 and having received at least 1 vaccination with AFFITOPE AD02
* Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits

Exclusion Criteria:

* Patients having received no vaccination with AFFITOPE AD02
* History of questionable compliance to visit schedule, patients not expected to finish the clinical trial
BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
2. At least 18 years of age
3. Otherwise in good health, as determined by physical exam and medical history
4. If female, and of child-bearing potential, is using an acceptable form of birth control
5. Negative urine pregnancy test at screening, if applicable
6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
2. Subjects who had previous gastrointestinal surgeries.
3. Subjects with known or suspected electrolyte abnormalities such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
4. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
6. Subjects undergoing colonoscopy for foreign body removal and decompression.
7. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
8. Subjects of childbearing potential who refuse a pregnancy test.
9. Subjects allergic to any preparation components
10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
11. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.