cyrilzakka/clinical-trials huggingface dataset:
Syncope Decision Aid for Emergency Care

Syncope, or transient loss of consciousness/fainting, is a common emergency department (ED) complaint responsible for over 1 million ED visits yearly. Potential causes include benign conditions such as dehydration or vaso-vagal syncope. Rarely, syncope is the result of serious cardiac conditions. In older patients without a clear cause of syncope hospital admission is frequently initiated at very low risk thresholds, though there is little evidence that these admissions improve patient outcomes. These decisions are often made without significant patient input or discussion of reasonable alternatives. In this situation, a patient's values, preferences, and particular circumstances should be taken into account. This mutualistic approach to clinical management is referred to as Shared Decision-Making. Shared Decision-Making (SDM) is a joint process of choice selection between providers and patients in clinical scenarios where multiple reasonable management options exist. To improve syncope emergency care, the researchers can leverage recent advances in risk stratification to engage patients in SDM and deliver superior, patient-centered care.

This study will provide the groundwork for a larger, randomized controlled trial evaluating the effects of the decision aid for management of low-risk syncope.

Setting:

Mount Sinai Hospital (MSH) has a 61-bed adult Emergency Department with a volume of over 100,000 patient visits/year or approximately 300 visits/day. MSH is a large academic tertiary care medical center located in East Harlem and serves a large black and Hispanic community.

Projected Recruitment: There are approximately 60 MSH ED visits for syncope per month of which 35 per month are by patients above age 30. Roughly half of these do not have a clear etiology of their syncope discovered in the ED. The researchers project that of the 17 potentially eligible patients per month, three will be successfully enrolled for a projected 72 patient enrollees at the completion of the 24-month recruitment period. The PI, clinical research coordinators, and SRAs will monitor the real-time electronic tracking system for all ED patients and will identify any patient over age 30 with a chief complaint of syncope or loss of consciousness.

Eligibility Criteria:
Inclusion Criteria:

* Emergency Department patient
* Age 30 years or above
* Chief complaint of syncope
* Capacity to make medical decisions
* Speak and read English
* Working phone number and fixed address

Exclusion Criteria:

* Altered Mental Status
* Cognitive Impairment
* Serious acute diagnosis:

  (e.g. clinically significant cardiac dysrhythmia, structural heart disease, gastrointestinal hemorrhage, myocardial infarction, pulmonary embolism, pneumonia, arterial dissection, serious infection, ectopic pregnancy, subarachnoid hemorrhage, or stroke.)
* Hemodynamic instability
* Inability to read or speak English
* Major communication barrier
* Lack of phone number or fixed address
* Too high risk as per physician judgment
The FEIBA NovoSeven Comparative Study

FENOC is a prospective, open-label, randomized, cross-over, multi-center study to investigate and compare the hemostatic effect and cost-efficacy of two different by-passing agents in the treatment of joint hemorrhages in subjects with severe hemophilia A and inhibitors. The study is designed as a clinical equivalency trial.

The incidence of inhibitors among people with severe hemophilia A has been documented as approximately 20-30% in several prospective studies. In such patients acute hemorrhages frequently occur and profoundly jeopardize health, with subsequent development of arthropathy. A common way of treating such bleeding episodes is to use bypassing agents. Among these agents the prothrombin complex concentrate FEIBA has been widely used for many years. More recently, recombinant factor VIIa (NovoSeven) has been added to the therapeutic options. While both products have been found effective in treating hemorrhages, the number of injections given for a bleeding episode has ranged widely, and it is so far unknown whether one of the products might have a better effect in certain patients.

Eligibility Criteria:
Inclusion Criteria:

* Congenital hemophilia A with an inhibitor and the need for by-passing agents in the case of joint bleeding.
* An expected bleeding frequency of \>=3 joint bleeds per year.
* Informed consent given.
* Age of two or older.

Exclusion Criteria:

* Other congenital and acquired bleeding disorders.
* Symptomatic liver disease.
* Life expectancy \<12 months.
Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis

Background: recurrent acute tonsillitis (RT) is a frequent condition affecting teenagers and adults. Patients suffer from recurring throat symptoms, fever and impaired quality of life (QOL). Tonsillectomy (TE) is the only well-known treatment, but studies indicate that tonsillotomy (TO) is associated with less morbidity (eg. pain and bleeding) and equal efficiency (e.g. reduced number of sore throat episodes and improved QOL). The investigator aim to clarify whether TO is a non-inferior alternative to TE.

Methods: inclusion and randomization of 250 adult RT patients for TE or TO with a 12 month follow up. Comparisons will be made between groups, and outcome measures includes number of sore throat episodes, QOL and postoperative pain.

Discussion: the study has the potential to improve the treatment of a prevalent disease by enhancing knowledge of an alternative procedure (TO) associated with less discomfort and risk than the current standard procedure (TE) and a presumably low risk of insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥15 years) with RT, defined as a minimum of five tonsillitis episodes in one year or a minimum of three tonsillitis episodes per year for two years (Danish National Guidelines criteria
* The ability to understand Danish orally and in writing.

Exclusion Criteria:

* Previous TE or TO.
* Suspected tonsillar malignancy.
* History of malignant tumor in the oral cavity, the pharynx or the larynx.
* Previous radiation therapy on head or neck.
* Hemorrhagic diathesis or anticoagulant therapy.
Evaluation of Three Potential Central Nervous System (CNS) Pretreatments for Soman Exposure on Human Performance

The primary objective of this study is to determine whether huperzine A, donepezil, and galantamine impact militarily relevant aspects of neurocognitive performance in humans, compared to placebo.

The primary objective of this study is to determine whether huperzine A, donepezil, and galantamine impact militarily relevant aspects of neurocognitive performance in humans, compared to placebo.

Secondary: Secondary objectives are to correlate neurocognitive performance effects with degree of inhibition and therefore sequestration of red blood cell AChE by huperzine A, donepezil, and galantamine, and to monitor the safety of the study drugs in healthy adult (18-39 years) males and females.

In a double-blind, randomized, placebo-controlled, parallel-groups design, normal, healthy, adult male and female volunteers will be administered one of the drug/doses. They will be tested prior to and periodically for militarily relevant performance tasks for up to 8 hours post-dose and for cholinesterase levels via finger prick.

Eligibility Criteria:
Inclusion Criteria:

* All healthy men and women 18 to 39 years of age are eligible to participate.

Exclusion Criteria:

Must be able to swallow whole pills.

* Self-reported habitual nightly sleep amounts outside the target range of 6-8 hours (i.e., less than 6 hours per night or more than 8 hours per night, on average)
* Cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, family history of sudden cardiac death or myocardial infarction) as determined by participant self report.
* Current hypertension or high blood pressure (greater than 140/90)
* Neurologic disorder (to include but not limited to epilepsy or another seizure disorder, amnesia for any reason, hydrocephalus, MS, narcolepsy or other sleep disorders)
* Kidney disease
* History of psychiatric disorder requiring hospitalization or psychiatric medication for any length of time
* Beck Depression Inventory score of 14 or above
* Underlying pulmonary disease requiring daily inhaler use
* Regular nicotine use (or addiction) (defined as more than 1 cigarette or equivalent per week) within the last 3 years
* Heavy alcohol use (more than 2 drinks per day; http://www.cdc.gov/alcohol/faqs.htm#10)
* Use of other illicit drugs (to include but not limited to benzodiazepines, amphetamines, cocaine, marijuana)
* Known liver disease or liver abnormalities as determined by a laboratory test
* Known ulcer disease or risk of ulcer disease (stomach bleeding)
* Self-reported history of caffeine use in excess of 400 mg (8 caffeinated sodas or 3-4 cups, each \~ 6 oz, of coffee) per day on average
* Pregnancy (females)
* Breast-feeding (females)
* Prior anaphylactic reaction, angioedema, or other severe psychological reactions to any of the test compounds
Psychometric Properties of Pain Scale in Low Back Pain

The aim of this study was to examine the Turkish validity of the Pain Behavior Scale in a population with chronic non-specific low back pain and to examine both intra-rater and inter-rater reliability. In addition, since this test package includes a series of functional activities, it is aimed to assess pain behaviors during functional movement in this population and to verify the test-retest reliability of physical performance tests.

To assess the extent to which individuals with chronic low back pain are affected during functional task performance, the presence or absence of pain behaviors and the severity of observed pain behavior should be considered. The Pain Behavior Scale has potential clinical application both for assessing pain behaviors during regular physical examination and for measuring the presence and severity of pain behaviors during functional movement. There is no similar assessment tool that offers all of these simultaneously. Therefore, this study aimed to examine the Turkish validity of the Pain Behavior Scale in a population with chronic non-specific low back pain and to test its intra- and inter-rater reliability.

Eligibility Criteria:
Inclusion Criteria:

* Non-specific low back pain for more than three months
* Being between the ages of 18-55
* Adequate cognitive functions (reading, writing, recall, orientation, language)

Exclusion Criteria:

* Presence of a serious underlying pathology (e.g. cancer, infection or cauda equina syndrome)
* Presence of spinal stenosis
* Presence of signs of radiculopathy (presence of neural symptoms such as pain radiating to the lower extremities, weakness, numbness and tingling sensation)
* Presence of fracture or surgical history in the relevant area
* Presence of rheumatic disease history
* Presence of pregnancy
A Survey of Patient's Attitudes Towards Consent For Clinical Research In Anesthesiology

In most current academic anesthesia groups, it appears that consent for research is acquired on the day of surgery. This practice raises concerns because the hospital may be regarded as a coercive environment and there may be the possibility that the immediate preoperative environment prohibits adequate time for understanding the research project and making an informed decision about participation. However, this is often the only opportunity for anesthesiologists to obtain research consent. The aim of the present investigation is to utilize a survey study to determine if patients at Evanston Hospital are comfortable consenting for research on the day of surgery

Patients participating in approved, minimal risk clinical research projects will be approached by the study investigators. Consent for clinical research will be obtained on the day of surgery in the ambulatory surgery unit. In addition, some patients will be contacted by telephone on the day prior to surgery to be informed that they will be approached about participation in a research project. If patients agree to participate in the clinical trial, they will be provided with a self-addressed envelope containing the survey and a brief cover letter. The research team member will explain the purpose of the survey (to determine patients' attitudes towards research consent on the day of surgery). Subjects will be requested to complete the survey within a week of the surgical procedure. Two days after surgery, the research team will provide a follow-up call to determine if there are any questions about completing the survey. Although patient names will not be identified on the survey packet, all surveys will be coded with the subjects study number for subsequent analysis.

Questions are designed to investigate six areas of potential concern relating to informed consent; comprehension, situation (privacy/time), obligation (pressure) motivation, compunction (regrets), and satisfaction. Subjects will reply using a 5-point scale from 1=strongly disagree to 5=strongly agree.

Eligibility Criteria:
Inclusion Criteria:

* Patients participating in approved, minimal risk clinical research projects will be approached by the study investigators

Exclusion Criteria:

* Inability to speak English
* Refusal to participate in the clinical research projects
Epidemiological Study to Evaluate the Management of Patients With Chronic Hepatitis C and Previous Treatment Failure

The purpose of this study is to describe the management of patients with chronic hepatitis C and previous treatment failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes older than 18 years old.
* Patients with hepatitis C who had previously failed to the standard therapy.
* Patients who have given written informed consent to participate in the study.

Exclusion Criteria:

* Patients with clinical and/or social conditions that might interfere with the development of the study (terminal diseases, cognitive detriment, severe psychiatric disease which prevent from obtaining the information required, prolonged absences during the study).
* Patients who are participating in other research trials or under treatment with any agent contraindicated according to the summary of product characteristics or other circumstance which requires a patient management different from the investigator's regular clinical practice.
An Observational, Multicenter Study to Evaluate the Safety and Effectiveness of Hetrombopag in Patients With ITP or AA

This is a multi-center, observational study in patients with Immune Thrombocytopenia (ITP) or aplastic anemia(AA) designed to describe the real-world safety and effectiveness of hetrombopag and assess the patterns of drug utilization to add to the knowledge base regarding the use of hetrombopag in routine medical practice. Patients eligible for participation will, as part of their routine medical care, be receiving hetrombopag for the treatment of ITP/AA

This is a multi-center, observational study in patients with ITP/AA designed to describe the real-world safety and effectiveness of hetrombopag and assess the patterns of drug utilization to add to the knowledge base regarding the use of hetrombopag in routine medical practice.

Patients eligible for participation will, as part of their routine medical care, be receiving hetrombopag for the treatment of ITP/AA

The scope of the study is to collect both retrospective and prospective data. The main part of the study will be prospective collecting data on usage, effectiveness, safety and patient-reported outcomes whereas the retrospective part will consist of collection of information on previous treatments, reason for treatment switch and, if applicable, hetrombopag treatment prior to enrollment. The retrospective data collection will be based on the information available in the patient's medical records. Data will be collected for up to 12 months prior to hetrombopag treatment start.

Prospective data will be collected at routine clinical visits throughout the study. Patients will be followed for 24 months and will be enrolled until their first scheduled visit after 24 months of enrollment, or until early termination, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* 1.Established and well documented ITP diagnosis
* 2.Patient is treated with, or at enrollment prescribed hetrombopag for ITP. Decision to initiate treatment shall be made by the treating physician and independently from the decision to include the patient in the study.
* 3.Signed and dated informed consent provided by the patient before any study-related activities are undertaken
* 4.Willing and able to comply with protocol requirements

Exclusion Criteria:

* Enrollment in a concurrent clinical interventional study
Continued Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine

This study is designed to determine the safety and immunogenicity of a Live Francisella tularensis Vaccine

Study Objectives:

1. To assess the safety of live F. tularensis vaccine NDBR 101.
2. To assess the immunogenicity of live F. tularensis vaccine NDBR 101.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old.
2. Females of childbearing potential must agree to have a urine or serum pregnancy test on vaccination day, immediately before vaccination (Exception: documented hysterectomy or \> 3 years of menopause). The results must be negative. Subjects must agree not to become pregnant for 3 months after receipt of the vaccine.
3. Subjects must be at risk for exposure to F. tularensis.
4. Subjects must have an up-to-date (within 1 year) medical history including concomitant medications, physical examination, and laboratory tests on their charts and be medically cleared for participation by an investigator.
5. Subject must be willing to return for all follow-up visits on days 1 and 2, between days 5-9, 12-16, 28-35, and 56-84 (if needed), all visits for serology, and the closeout interview 6 months (±14 days) after vaccination or revaccination.
6. Subject must agree to report any adverse event which may or may not be associated with administration of the test article for at least 28 days after vaccination.

Exclusion Criteria:

1. Over the age of 65 Years.
2. Vaccinated against tularemia within the last 10 years or had a documented, confirmed tularemia infection.
3. Clinically significant abnormal lab results including evidence of hepatitis C, hepatitis B carrier state, or elevated liver function tests (two times the normal range or at the discretion of the PI).
4. Personal history of an immunodeficiency or current treatment with an oral or intravenous immunosuppressive medication.
5. Confirmed HIV\* infection.
6. A medical condition that, in the judgment of the Principal Investigator (PI), would impact subject safety.
7. Antibiotic therapy within 7 days before vaccination.
8. Pregnancy or lactation. Subjects must agree not to become pregnant for 3 months after receipt of the vaccine.
9. Any known allergies to any component of the vaccine:

   Modified casein partial hydrolysate medium Glucose cysteine hemin agar Sucrose gelatin agar stabilizer
10. Administration of another vaccine within 4 weeks of tularemia vaccination.
11. Any unresolved AE resulting from a previous immunization.
Astragalus Membranaceus for Brain Edema Induced by Hemorrhagic Stroke

Astragalus membranaceus (AM) is used to treat stroke for a long period, and a number of studies have known that AM can reduce cerebral infarction area and has anti-oxidation. Hemorrhagic stroke will induce secondary peri-blood clot edema and that may increase intracranial pressure to exacerbate clinical symptom. Therefore, the purpose of the present study was to investigate the effect of AM on hemorrhagic stroke edema. The investigators selected 80 hemorrhagic stroke patients , and who the stroke is first attack, they were randomly divided into control and experimental groups, and each group was 40 patients as follows: 1) control group, accepted AM placebo 2.8 g three times per day (tid) treatment for continuously 14 days from second day of admission or operation, except standard ordinary treatment; 2) experimental group, accepted AM 2.8 g tid treatment for continuously 14 days from second day of admission or operation, except standard ordinary treatment. Computer tomography (CT) examination was done at first day, 4th day and 7th day of admission, respectively. The ratio of brain edema was calculated by CT image, and inflammatory index including the levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR)，Creatine Kinase BB Isoenzyme (CMBB). D-dimer from venous blood also were measured. In addition, the score including Glasgow outcome scale (GOS), Modified rankin scale (MRS), Function independence measure (FIM), Barthel index (BI) was recorded one week, four weeks and 12 weeks after admission or surgical operation, as an index for clinical symptoms. The index for the therapeutic effect of AM was according to above-mentioned the ratio of brain edema, inflammatory index and clinical symptoms.

The investigators expected the results of the present study may provide a scientific evidence for the hemorrhagic stroke edema treatment of AM, thus, the present study may contribute to use the method of integrated Chinese and Western Medicine for the treatment of stroke, and to the research of Chinese Medicine.


Eligibility Criteria:
Inclusion Criteria:

1. female or male;
2. aged between 30 and 75 years;
3. randomized allocation to a study group within 24 hours of hemorrhagic stroke onset;
4. this was the patient's first hemorrhagic stroke, and the location of hemorrhage was the putamen;
5. treatment may or may not have been included surgery; and
6. the subject or their legal representative gave written informed consent to participate.

Exclusion Criteria:

1. recent thrombolysis treatment;
2. history of previous stroke;
3. full-dose or long-term anti-coagulation therapy;
4. hemorrhagic stroke but the location was not putamen;
5. coexisting systemic diseases such as terminal cancer, renal failure, liver cirrhosis, severe dementia, or psychosis;
6. participation in another clinical trial within the last three months; and
7. pregnancy or lactation.
Efficiency of New Technologies in the Aging Process

This study tries to analyze the effectiveness of the application of the new technology in the maintenance of an active time. To do this, the investigators performed a laboratory test where they evaluated the physical and cognitive variables before and after the intervention and analyzed the improvement in the psychocognitive abilities in the experimental group and the use of physical and cognitive functions in the control group.

The main objective of this study is the demonstration of the effectiveness of a motor task, making use of the Nintendo Wii video game console, in healthy elderly people, as well as demonstrating the interaction between the physical and cognitive aspects and the decline that in these functions causes the aging process. Methodology: A double blind, controlled and randomized clinical trial was developed on a total sample of 46 subjects, with a mean age of 72.59 years. For the collection of data, the following evaluation scales and computerized tests were passed (Cognitive Miniexamen, Depression Scale, Berg Scale, Tinetti Scale, Timed Up and Go test, Oddball Test and the Attention Network Test).

Eligibility Criteria:
Inclusion criteria:

* Be 60 years old or older.
* Have compensated the auditory or visual deficits that could suffer
* Absence of musculoskeletal problems that hinder functionality

Exclusion criteria:

* Presents cognitive impairment
* Obtain values in the Geriatric Depression Scale\> 9.
* Presenten pathologies where the development of a motor task is counterproductive
* Sleep less than 6 hours a day