cyrilzakka/clinical-trials huggingface dataset:
Simulation to Assess Cognitive Workload and Task Load IndeX (TLX) Performance

High-fidelity simulation (HFS) is a learning method extensively used for training of surgical specialty (including anesthesia) and nurses. It has a beneficial effect on knowledge of algorithms, team working, early warning scores, and communication. Various skills can be learned using a standardized simulation programs.

The complexity of instructional design may produce cognitive overload, high stress level and anxiety. This may increase fatigue, facilitate errors, and is associated with inferior task performance which may impede memorization of learned skills resulting in inefficient learning/simulation failure. Subjectively reported scales can accurately identify the level of perceived workload and mental demand in individuals during simulation tasks. One example is the National Aeronautics and Space Administration (NASA)-TLX - the most accepted subjective measure of human workload in various industries including medicine.

Surgical specialty (including anesthesia) and nurses training curriculum in Lyon, France, includes several HFS scenarios with a large panel of critical events. The investigators aim to evaluate the effect of burden of workload and stress perceived by surgical specialty (including anesthesia) residents and nurses during HFS on the learning performance, and to grade different learning scenarios by their difficulty.

In this observational study investigators aim to measure anesthesiology, surgeon residents and nurses' workload, stress level, and performance on high-fidelity simulation scenarios used routinely in the current anesthesiology, nurse and surgical training curriculum. A NASA TLX scale, 100 points numeric scale for anxiety (0 - no anxiety; 100 - maximal anxiety), automated quantitative pupillometry, Team Emergency Assessment Measure scale will be used to evaluate a workload, anxiety, stress, and performance. Age, sex, previous experience of HFS will be noted. All data will be anonymized. The participation in this study is voluntary and one can withdraw from this study at any time prior to or after the completion of any interview without any penalty.

Two investigators will independently evaluate the performance of HFS by direct observation and video record if necessary. NASA TLX questionnaire will be administrated immediately after HFS scenario and before the debriefing. Anxiety scale and pupillometry will be administrated before the beginning of HFS scenario and upon its completion.

Eligibility Criteria:
Inclusion Criteria:

* Lyon University medical student status on the day of the study
* Enrolled in surgical specialty (including anesthesia) simulation training program

or

* Lyon Anesthesia Nurses School student status on the day of the study
* Enrolled in surgical specialty (including anesthesia) simulation training program
* voluntary

Exclusion Criteria:

* denial to participate
Epidemiological Study in Thai Participants With Hypertension

The purpose of this study is to evaluate blood pressure (BP) goal attainment in adult participants with essential hypertension.

This study has been designed as a non-interventional, observational study to obtain information on hypertension treatment regimens and how well hypertension is controlled in Thai patients in real-life settings. Antihypertensive medications prescribed in this study will be at the discretion of the investigator and the standard of care practice at the particular study site.

The study will enroll approximately 2000 patients. Participants with well-controlled hypertension on their current antihypertensive therapy will participate in the study for only 1 visit. Participants with history of hypertension who are uncontrolled on the current antihypertensive medications or participants with newly diagnosed hypertension (diagnosed within the past 4 weeks and uncontrolled on antihypertensive therapy) will be observed over the course of 12-16 weeks. These participants will make 3 visits to the study site.

This multi-centre trial will be conducted in Thailand.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent
2. Age above 18 years.
3. Participants with essential hypertension as per European Society of Hypertension/European Society of Cardiology (ESH/ESC) criteria in general, target blood pressure (BP), systolic blood pressure (SBP) \<140 and diastolic blood pressure (DBP) \<90 mmHg, in diabetes, target BP, SBP \<140 and DBP \<85 mmHg, in renal disease with overt proteinuria (urine albumin excretion \> 300 mg/day or 200 microgram/min), target BP, SBP \<130 and DBP \<90 mmHg).

Essential Hypertension will be defined based on the criteria established by the ESH/ESC 2013 criteria:

* Grade 1 Essential hypertension - Systolic blood pressure (SBP) 140 - 159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg with no identifiable cause
* Grade 2 Essential hypertension - SBP 160 - 179 mmHg and/or DBP 100 - 109 mmHg with no identifiable cause
* Grade 3 Essential hypertension-SBP ≥ 180 and/or DBP ≥ 110 mmHg with no identifiable cause.

Exclusion Criteria:

1. Female participants who are breastfeeding or pregnant or who are intending to become pregnant.
2. Has known or suspected secondary hypertension.
3. Is currently enrolled in or has not yet completed at least 30 days since ending an investigational product or device study or is receiving other investigational agents.
Metabolomic Analysis of Body Fluid of Medulloblastoma in Children

Based on a new mass spectrometry system, body fluid samples were analyzed to verify the role of metabolite analysis in the diagnosis of pediatric medulloblastoma.

Screening specific molecular metabolic markers for medulloblastoma after radiotherapy can improve the prediction of clinical diagnosis and prognosis of patients.The purpose of this study is to validate the role of metabolite analysis in the diagnosis of pediatric medulloblastoma based on the analysis of body fluid samples by a new mass spectrometry system.Based on the metabolic markers found by screening, the pathogenic mechanism of metabolic pathway blockade was explained, and the scientific basis for later treatment was put forward.

Eligibility Criteria:
Inclusion Criteria:

* The samples are previous biological sample database data;
* Sample collection time was 2017.05-2019.05;
* The patient's age is over 3 years old;
* KPS score ≥50 at the first diagnosis;
* The patient was a medulloblastoma patient who had received surgical treatment and had not received radiotherapy or chemotherapy before.

Exclusion Criteria:

* Recurrent patients;
* Patients suffered from other malignant tumors during radiotherapy;
* The body fluid samples or related clinical data are not perfect;
* Storage failure of body fluid samples such as lipid dissolution and hemolysis occurred.
Womens Study to Alleviate Vasomotor Symptoms

This study tests the hypothesis that a low-fat, vegan diet including soybeans reduces the frequency and severity of menopausal hot flashes, and tests the hypothesis that total isoflavone intake is associated with the reduction in the frequency and severity of hot flashes.

Women with postmenopausal hot flashes will be recruited via social media and randomly assigned to an intervention or control group. The intervention group will be asked to consume a low-fat, vegan diet including ½ cup (86g) cooked soybeans (30 g uncooked) for 12 weeks. Support will be provided by weekly meetings conducted via an Internet video conferencing platform (e.g., Zoom), along with individual counseling as needed. The control group will be asked to make no diet changes for 12 weeks but will be offered instruction in how to follow a vegan diet and about the potential role of soybeans after the 12-week point. The frequency and severity of hot flashes will be assessed before, during, and after the 12-week intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Post-menopausal women aged 40-60 years
2. English fluency
3. Moderate-to-severe hot flashes experienced at least twice per day
4. Started menopause within the last 10 years
5. No menses in preceding 12 months
6. Access to an iPhone or Android phone and willingness to install a hot-flash recording app.
7. Willingness to participate in weekly classes
8. Willingness to follow a low-fat vegan diet, including daily consumption of soybeans.

Exclusion Criteria:

1. Use of hormonal medications in the preceding 2 months
2. An explanation for hot flashes other than menopause (e.g., medication use, cancer treatment)
3. Smoking during the past six months
4. History of an eating disorder or evidence of a current eating disorder (as determined by an eating disorder diagnosis, the discretion of a qualified medical professional, or an Eating Attitudes Test-26 score \>20)
5. Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
6. Use of recreational drugs in the past 6 months
7. Use of weight-loss medications over the last 6 months or a current attempt to lose weight
8. Body Mass Index \< 18.5 kg/m2
9. Soy allergy
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia

This observational study will investigate hemoglobin levels and Mircera (methoxy polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and compare standards of care between centers. Data from each patient will be collected over 12 months of Mircera therapy.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/= 18 years of age
* chronic kidney disease
* informed consent for data transmission

Exclusion Criteria:

* serious hematological or infectious disease
* acute bleeding in the 16 weeks preceding data collection
* participation in an interventional trial
* female patients: pregnancy or breast-feeding
Ryan Companion Robot for Assisting Elderly People With Alzheimer's Disease

The objective of this project is to conduct research and a pilot study to demonstrate the potential clinical impact and technical feasibility of a socially-assistive robot, called Ryan Companionbot (hereafter Ryan), for life improvement and intervention of persons with early stage Alzheimer's disease (AD) and AD related dementia (ADRD). Earlier phases of this project demonstrated the feasibility and scalability of using emotion recognition technology based on cutting-edge natural language processing and artificial intelligence technologies to improve mood and lessen depression symptoms of persons with early stage AD/ADRD. In this phase, the investigators will utilize an aesthetically pleasing updated Ryan (V2.0) with emotion recognition and natural language processing for enhanced conversations to address the needs of the individuals with AD/ADRD and their healthcare providers as well as to test the effectiveness of Ryan by comparing participants pre- and post-treatment by analyzing several blood biomarkers related to AD/ADRD and depression. The investigators will recruit thirty participants from local senior living facilities based on their cognitive performance as assessed by the Saint Louis University Mental Status (SLUMS) score. SLUMS is commonly used as a simple screening/assessment test in senior living facilities. As part of the recruitment, the investigators will show prospective participants a video recording of a previous senior volunteer interacting with Ryan to give new recruits an idea of the socially assistive robot technology.


Eligibility Criteria:
Inclusion Criteria:

* HAVING EARLY STAGE AD/ADRD AS ASSESSED BY THE SLUMS SCORE (BETWEEN 15-26),
* VERBAL SKILL TO INTERACT,
* BEING AVAILABLE FOR A PERIOD OF 8-10 WEEKS TO INTERACT WITH RYAN,
* HEALTHY INDIVIDUALS WEIGHING AT LEAST 110 POUNDS (FOR SAFE COLLECTION OF BLOOD SAMPLES).

Exclusion Criteria:

* AGGRESSIVE BEHAVIOR
* DIAGNOSTICS OF SEVERE DEMENTIA OR MEMORY LOSS
* ACUTE PHYSICAL ILLNESS THAT IMPAIRS ABILITY TO PARTICIPATE
* DURING THE STUDY IF A PARTICIPANT'S MID-STUDY SLUMS SCORE IS LESS THAN 15 (INDICATING MORE SEVERE DEMENTIA) AND/OR THE PHQ-9 IS EQUAL TO OR GREATER THAN 20, THE CUTOFF FOR SEVERE DEPRESSION, THE RESEARCHERS WILL REMOVE THE PARTICIPANT FROM THE STUDY
* IF A PERSON IS UNCOMFORTABLE WITH BLOOD DRAW, HE/SHE IS EXCLUDED FROM THE STUDY.
Preventability of Infections in Residents of French Nursing Homes

STUDY HYPOTHESIS : An infection prevention program adapted for the nursing home context can reduce by 5% the number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes.

STUDY DESIGN : The proposal is for an interventional cluster (nursing home) study comprising 2 randomized groups: group 1 (interventional), comprising 25 nursing homes implementing a specific infection prevention program; and group 2 (control), 25 nursing homes continuing to implement their routine prevention measures.


Eligibility Criteria:
Inclusion Criteria:

* Nursing homes which contain a medical coordinator and at least one nurse and/or nursing auxiliary.
* Nursing Homes located in France (North-West)
* All the residents present or entering the facility during the study period

Exclusion Criteria:

* Nursing homes where a prevention program has already been implemented
Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function

To evaluate the potential effects of artemether- lumefantrine on the auditory function


Eligibility Criteria:
Inclusion Criteria

* 12 years of age or older
* Accepts Healthy Volunteers
* P. falciparum parasitemia between 1,000 and 100,000 parasites/μl
* History of fever or presence of fever (temperature ≥ 37.5°C)

Exclusion Criteria

* Signs/symptoms of severe/complicated malaria
* Ingestion of various antimalarial drugs, or antibiotics in the previous 2 weeks to 2 months
* History of any drug-related hearing impairment
* Abnormal hearing function at study entry
* Exposure to sustained loud noises, by self-report, within the past 24 hours
* Present ear problems
* Pregnant or lactating (urine test for β-HCG) to be performed on any woman of child bearing age)

Other protocol-defined inclusion/exclusion criteria may apply.
Long Term Safety and Efficacy Study of ProSavin in Parkinson's Disease

The study is designed to assess the long term tolerability of ProSavin and whether it is safe and efficacious in patients administered ProSavin from the PS1/001/07 study .


Eligibility Criteria:
Inclusion Criteria:

* must have met all inclusion criteria for study PS1/001/07
* willing to have L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant antiparkinsonian medication.
* affiliated with the French social security health care system (Patients enrolled in France only)
* signed and dated written informed consent obtained from the patient and/or the patient's legally acceptable representative, if applicable, in accordance with the local regulations
* must have been treated with ProSavin/Sham

Exclusion Criteria:

-
A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease

The purpose of this study is to evaluate the safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. The hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect.

Patients with GVHD grade 2-4, will receive decidual stromal cells at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.

Eligibility Criteria:
Inclusion Criteria:

* Acute graft versus host disease grade 2-4 or therapy resistant chronic graft versus host disease.
* Are on calcineurin inhibitor and high dose corticosteroids.

Exclusion Criteria:

* Terminally ill patients
Insulin and Polycystic Ovary Syndrome

Increased insulin levels leads to increased secretion of D-chiro inositol(DCI) from the kidneys in women with PCOS, but not in normal women. This leads to a reduction in circulating DCI and insulin stimulated release of DCI-IPG.To determine if decreasing circulating insulin directly by inhibition of islet insulin release with diazoxide in obese women with PCOS 1)decreases the renal clearance of DCI and 2) increases the circulating concentration of DCI.


Eligibility Criteria:
Inclusion Criteria:

* Obese women with PCOS and normal women aged 18-40,
* PCOS less than 8 periods/year, elevated total or free testosterone, normal thyroid function tests and serum prolactin, exclusion of adrenal hyperplasia
* Normal regular monthly periods, no clinical evidence of androgen excess,
* All Acceptable health on interview, medical history, physical exams and lab tests, signed, witnessed informed consent and ability to comply to study requirements

Exclusion Criteria:

* DM, clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic or malignant disease.
The GAstric Precancerous Conditions Study

Gastric cancer afflicts 27,000 Americans annually and carries a dismal prognosis. One reason for poor outcomes is late diagnosis, as the majority of gastric cancers in the United States are diagnosed at a relatively advanced stage where curative resection is unlikely. Gastric precursors (such as atrophic gastritis and intestinal metaplasia) are precancerous changes to the stomach mucosa which increases risk for subsequent gastric cancer.

The Gastric Precancerous Conditions Study (GAPS) is an observational study of patients at elevated risk for gastric cancer. Investigators seek to recruit patients from endoscopy unit of Stanford Health Care, a large academic network of hospitals and clinics serving Northern California. Investigators will recruit patients who are both symptomatic (e.g. dyspepsia) and asymptomatic (e.g. referred for screening), and individuals both with known precursor lesions (such as intestinal metaplasia) or at high risk for carrying precursor lesions. A component of the study is long-term follow-up of individuals with gastric precursors. This is to understand their risk factors for histologic progression and regression. During both index and subsequent endoscopies, the study team will collect biospecimens (e.g. blood, saliva, gastric tissue).


Eligibility Criteria:
Inclusion Criteria: Subjects between the ages of 35 and 84, who are undergoing outpatient endoscopy for the following indications are eligible: abdominal pain, dyspepsia, iron deficiency anemia, Helicobacter assessment, surveillance of suspected or known intestinal metaplasia, evaluation for family history of gastric cancer

Exclusion Criteria:

* Cannot give consent
* Have history of gastric surgery
* Have history of solid tumor or bone marrow transplant
* Platelet Count \< 70 or international normalized ratio \> 1.5
A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome

This is a multicenter, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety study of KRN321 of subcutaneous injection in Adult Subjects with Low- or Intermediate-1-Risk Myelodysplastic Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* IPSS low- or intermediate-1-risk MDS diagnosed at enrollment
* Serum EPO concentration ≤ 500 mIU/mL
* Hemoglobin concentration ≤ 9.0 g/dL at the screening examinations

Exclusion Criteria:

* Previous bone marrow or hematopoietic stem cell transplantation
* History of pure red cell aplasia
* Cardiac conditions including angina pectoris, congestive heart failure, uncontrolled arrhythmia and hypertension
* Those who have increased risk of thrombosis during the study
* Uncontrolled diabetes mellitus
* Concurrent active infection or chronic inflammatory disease
* Other causes of anemia
* Previous or concurrent active malignancies other than MDS
The Best Dosage and Timing of Polyethylene Glycol for Bowel Preparation Before Capsule Endoscopy

The aim of this study is to evaluate the ideal dose of PEG and timing of bowel preparation in patients referred for CE examination.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 75 years and referred to capsule endoscopy because of suspected small-bowel disease are prospectively eligible for entry into the study.

Exclusion Criteria:

* Age \< 18 or \> 75 years
* Known or suspected GI stricture or fistula
* A history of GI tract resection
* Swallowing disorders
* Intensive therapy with fasting and parenteral nutrition;with a disease that may reduce movement of the GI tract, such as diabetes mellitus
* Medications that could affect gastrointestinal movement within one week
* Implanted with a medical electronic device
* Active inflammatory bowel disease, toxic megacolon, toxic colitis
* Severe pulmonary, cardiac, renal, or hepatic disease
* Uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg);
* Disturbance of electrolytes
* Pregnancy or lactation
* Patients inability to provide written voluntary informed consent
* Participation in another clinical study