cyrilzakka/clinical-trials huggingface dataset:
Micro-expression Reading Skill Training in Medical Students

This study was undertaken to investigate the effectiveness of the Micro Expression Training Tool (METT) and the Subtle Expression Training Tool (SETT) to help improve the non-verbal communication skills of medical students.

Teaching and assessing communication skills is an important component of medical school curricula, and it is not easy for medical students to develop non-verbal communication skills without adequate training. This study was undertaken to investigate the effectiveness of the Micro Expression Training Tool (METT) and the Subtle Expression Training Tool (SETT) to help improve the non-verbal communication skills of medical students.

Eligibility Criteria:
Inclusion Criteria:

* Year 1 and 2 medical students, PNUSOM

Exclusion Criteria:

* incomplete survey response
Study for Determination of Feasibility and Toxicity of Pre-Treatment With HPPH (2-1[1-Hexyloxyethyl]-2 Devinyl Pyropheophorbide-a) Photodynamic Therapy Prior to Chemoradiation in Non-Operable Patients With Obstructive Esophageal Cancer

This study aim is to find out what effects capecitabine, oxaliplatin and radiation therapy following photodynamic therapy have on esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Partially or completely obstructing primary esophageal carcinoma, clinical stage I-IVa as determined by endoscopy, CT-scan, PET +/- endoscopic ultrasound. For distal esophagus tumors involving the GE junction, at least 50% or greater of the tumor bulk should be in the distal esophagus
* Ineligible for or refused surgical resection
* No Prior therapy allowed for esophageal cancer
* ECOG Performance status 0-1
* Life expectancy \> 4 months
* Adequate hematologic parameters (hemoglobin\> 9g/dl, ANC \> 1500/ul, Platelets \> 100,000/ul)
* Adequate biochemical parameters (total bilirubin and creatinine within institutional limits, AST and alkaline phosphatase less tham or equal to 3xUNL)
* Age \> 18 years
* Signed informed consent
* Bronchoscopy with biopsy and cytology if primary esophageal cancer is \< 26 cm from incisors
* Female patients of childbearing potential should have a negative serum or urine pregnancy test within 7 days prior to registration
* Patients of Childbearing potential agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method
* Both men and women and members of all races and ethnic are eligible for this trial

Exclusion Criteria:

* Hypersensitivity to platinum compounds, fluoropyrimidines or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy
* Patients may not be receiving any other investigational agents
* Patients with known brain metastases should be excluded from this trail
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements
* Peripheral neuropathy ≥ Grade 2
* History of second malignancy within the previous years except for curatively treated carcinoma of the cervix in-situ or non-melanomatous skin cancer
* Patients who are pregnant or lactating
* Porphyria or hypersensitivity to porphyrin-like compounds
* Patients with known HIV or Hepatitis B or C (active, previously treated or both)
* Patients with tracheal or bronchial involvement, as determined by bronchoscopy
* Patients with documented unilateral or bilateral vocal cord paralysis
* Patients with T4 lesions by CT, MRI or EUS involving the aorta, lung or pericardium
Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks

The purpose this research is to compare two different standards of care for pain management and two different standards of care for local numbing medicine for breast cancer patients who will have a total mastectomy.

The purpose this research is to compare two different standards of care for pain management and two different standards of care for local numbing medicine for breast cancer patients who will have a total mastectomy.

Standard of care intervention is preoperative PECS-II blocks versus Intraoperative Pectoral Blocks.

The medication used are standard of care and include Bupivacaine and liposomal bupivacaine. Bupivacaine is FDA approved and indicated for the local or regional anesthesia or analgesia for surgery procedures and therapeutic procedures. Liposomal bupivacaine is FDA approved and indicated for adults to produce postsurgical local analgesia and as nerve block to produce postsurgical regional analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 years of age or older
* Patients undergoing mastectomy with or without axillary surgery, with or without reconstruction surgery at UCMC for breast cancer or high-risk of breast cancer. Patients with high-risk of breast cancer are those who have atypical/precancerous breast lesion(s), genetic mutation with increased risk of cancer (e.g., BRCA1, BRCA2 etc..) and/or a strong family history of breast cancer in the opinion of the investigator.

Exclusion Criteria:

* Patients undergoing only a partial mastectomy or tissue-based reconstruction.
* Non-English speaking.
* Patients who are pregnant.
* Patients with an allergy to local anesthetics
* Except: patients with allergies only to topical anesthetics may be included.
* Patients with a preoperative acute or chronic pain disorder with an opioid prescription that has been prescribed within 30 days of surgery. Patients who have not filled such a prescription or who state they have not taken the medications prescribed, may be eligible on a case-by-case basis per investigator judgement.
* Patients with a history of opioid use disorder.
* Inability to provide informed consent.
* Patients who otherwise in the opinion of the Investigator are not good candidates for participation (e.g., deemed unreliable for follow-up).
Systemic Organ Communication in STEMI

Despite progress in pre-hospital care, ambulance logistics, pharmacotherapy and PPCI techniques, ST-segment elevation myocardial infarction (STEMI) continues to confer a substantial burden of morbidity and mortality.

Within the STEMI population, there is a spectrum of higher and lower risk patients. The aim of this cohort study is to collect prospectively and systematically clinical research data from STEMI patients. This cohort study is an open-end observational study to identify master switches in myocardial ischemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from STEMI

Exclusion Criteria:

* \< 18 years
The Effect of Dietary Nitrates on Physical Performance and Vascular Function in Chronic Kidney Disease

The purpose of this study is to examine the effect of acute ingestion of a concentrated beetroot juice supplement on vascular function and exercise capacity in patients with moderate to severe chronic kidney disease

People with Chronic Kidney Disease (CKD) are at an increased risk of cardiovascular disease. Blood vessel dysfunction and exercise intolerance are common in CKD. Blood vessel dysfunction has been shown to predict future cardiovascular events and decreased physical activity can contribute to an increased risk of cardiovascular disease. Therefore, this study investigates if dietary nitrate from beetroot juice, which has been shown to improve blood vessel function and exercise capacity in other cardiovascular disease pathologies, could be effective at improving these measures in patients with CKD. In a controlled, double blinded trial, stage 3-5 CKD patients will be randomly assigned to receive either beetroot beverage or a placebo and then complete measures of blood vessel function and an exercise test.

Eligibility Criteria:
Inclusion Criteria:

• Stage 3-5 Chronic Kidney Disease

Exclusion Criteria:

* History of cardiovascular disease
* Current pregnancy
* Uncontrolled hypertension
* Uncontrolled hyperlipidemia
* Current hormone replacement therapy
* Current use of tobacco products
* Current autoimmune disease
* Current hyperkalemia
* Diagnosis of a deep vein thrombosis (DVT) within the last 6 months
Evaluating Whether Charity Incentives Motive Cancer Survivors to Increase Physical Activity

The investigators propose to examine whether linking daily activity with charity-based incentives motivates cancer survivors to initiate and maintain physical activity. Linking daily physical activity goals with a cancer specific charity incentive may provide a uniquely salient motivator that promotes increased physical activity among cancer survivors. The investigators will examine whether using activity monitors in combination with charitable incentives leads to greater increases in physical activity compared to activity monitors alone. Target participants includes cancer survivors who are not already active. Physical activity (e.g., steps per day, time in moderate-intensity activity) will be examined at baseline and following a 12-week intervention period using an activPAL accelerometer. After the baseline assessment, both groups will receive a fitbit monitor and informational material designed to increase physical activity. Participants in the fitbit+charity group will have donations made in their name to a cancer charity if they meet daily step goals. Physical activity levels will be monitored using the fitbit device for 6-weeks following the formal intervention period.

The study is a Randomized Controlled Trial (RCT) of a 12-week physical activity intervention. Fifty cancer survivors will be recruited and allocated to one of two research arms: Fitbit+Only Group or Fitbit+Charity Incentives Group. Participants in both intervention arms will be asked to track their physical activities using Fitbit One, an activity monitor that monitors steps and physical activity and will receive basic educational materials about increasing physical activity. Those in the Fitbit+charity incentives Group will raise money for cancer charities if they meet weekly step targets.

The key outcome variable of the RCT is steps as measured by an activPAL accelerometer. Data will be collected at baseline and 12-weeks. Fitbit data will also be collected for the duration of the 12-week intervention and for 6-weeks following the end of the intervention period to have an initial examination of behavior change maintenance (total 18-weeks).

Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥ 18 years and \<50 y, with diagnosed Adolescent or Young Adult cancer (diagnosed between 15-39y of age);
2. ≥ 6 months post-cancer treatment
3. English speaking
4. Participate in \<60 minutes of MVPA/week
5. Own a smartphone
6. Have access to computer
7. Participants must also pass a physical activity readiness questionnaire or receive medical clearance from their primary care physician or oncologist.

Exclusion Criteria:

1. Joint, cardiovascular, or respiratory problem(s) precluding physical activity
2. Metastatic disease
3. Planned elective surgery or pregnancy during intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery).
4. Already using a wearable device \>5 days per week
Fluoropyrimidine Tailored-dose Based on Uracil Concentration in Patients Treated for Digestive Carcinomas: Evaluation of Clinical Practice

Digestive carcinomas chemotherapies regimen are mostly based on fluoropyrimidine drugs (5-Fluorouracil (5-FU) or capecitabine). 5-FU is mainly catabolised by dihydropyrimidine dehydrogenase (DPD) and partial or complete DPD deficiency can cause severe adverse reactions. Different strategies have been proposed to predict DPD deficiency; the two main approaches are phenotyping the enzyme activity (directly or indirectly), or genotyping the four main polymorphisms associated with 5-FU-toxicity. In February 2018, the French medicines agency (Agence nationale de sécurité du médicament et des produits de santé, ANSM) recommended DPD genotyping for all patients receiving fluoropyrimidine-based treatment to improve its safety as compared to the European Medicines Agency (EMA)13 and others pharmacogenetics working group.

In December 2018, a new guideline from the French cancer institute (Institut National Du Cancer, INCa) and the French health authority (Haute Autorité de Santé, HAS) recommended the measurement of the uracil blood level before genotyping DPD and dose adaptation if this level is greater than 16 ng/mL. The aim herein is to assess how this recommendation has been implemented in clinical routine. 5-FU displays a dose-response relationship regarding both its efficacy and its toxicity, did tailored-dose impair the treatment efficacy as it decreased the risk of toxicity? To address that matter we conducted a retrospective study to evaluate how fluoropyrimidine dosage is adapted to uracil concentration with an emphasis on how patients outcome were affected. We compared time to failure and overall survival between patients with an uracil concentration \< 16 ng/mL and \> or = 16 ng/mL.


Eligibility Criteria:
Inclusion Criteria:

* Digestive cancer
* An uracil dosage performed between February 2018 to January 2020
* Received at least one cycle of fluoropyrimidine-based chemotherapy in one of the three oncology departments (Hopital Edouard Heriot \[Lyon\], Centre Hospitalier de Lyon Sud \[Lyon\], Hopital de la Croix Rousse \[Lyon\]).

Exclusion Criteria:

* Age limit less than 18 years
* Not treated with fluoropyrimidine based chemotherapy
* Missing data for uracil concentration or chemotherapy dosage
Dry Needling in Post-operative Shoulder Pain

Fractures of the proximal humerus account for between 5% and 8% off all reported fractures. Post-operative shoulder pain is highly frequent. Due to either surgical procedure, soft tissues surrounding the shoulder area can be damaged. The purpose of the current clinical trial was to compare the effects of physiotherapy versus physiotherapy plus TrP-DN on pain and function in patients who exhibit post-operative shoulder pain after a PHILOS procedure for proximal humeral fixation or rotator cuff tear repair.


Eligibility Criteria:
Inclusion Criteria:

* proximal humeral fracture
* rotator cuff tear
* open reduction and internal fixation with PHILOS© plate (Synthes, Switzerland)
* rotator cuff tear repair
* post-operative shoulder pain
* active TrPs in the neck-shoulder muscles

Exclusion Criteria:

* no active TrPs
* multiple fracture
* previous surgery
* cervical radiculopathy or myelopathy
* diagnosis of fibromialgia
* having undergone any physical therapy intervention in the year before the surgery
* fear of needles
* any contraindication for dry needling
Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI)

Heparin reversal by protamine administration after transcatheter aortic valve implantation (TAVI) may reduce bleeding events. However, protamine can also cause life-threatening allergic reactions. High-quality evidence regarding the clinical safety and efficacy of routine protamine administration after TAVI is lacking.

The aim of this clinical trial is to determine if routine protamine administration, compared with selective protamine administration, reduces the risk of cardiovascular mortality or bleeding within 30 days after transcatheter aortic valve implantation.


Eligibility Criteria:
Inclusion Criteria:

* Aged \> 18 years
* Undergoing transfemoral TAVI with any commercially available transcatheter heart valve
* Provided written informed consent

Exclusion Criteria:

* Documented protamine allergy or anaphylaxis
* Recent PCI (\< 3 months before TAVI)
* Planned arterial access via surgical cut-down
* Pregnancy
Air Pollution and Health of COPD Patients

This panel study aims to evaluate the effects of air pollutants on cardiopulmonary health of patients with chronic obstructive pulmonary disease (COPD) and explore the potential biological mechanisms.

This panel study was conducted in a group of stable patients with COPD in Beijing, China. The health measurements including lung function, blood pressure and airway inflammation were conducted, and morning urine, exhaled breath condensate, saliva and venous blood were collected at the time of enrollment and at 3, 6 and 9 months after enrollment. Individual exposures to fine particulate matter (PM2.5), black carbon (BC), ozone (O3) and nitrogen dioxide (NO2) were performed for 24 hours at each follow-up. And the daily concentrations of air pollutants were collected from the Beijing Air Quality Real-time Publishing Platform and meteorological data were collected from the National Meteorological Information Center. The linear mixed effects model was used to analyze the association between air pollution and cardiopulmonary health in patients with COPD.

Eligibility Criteria:
Inclusion Criteria:

* doctor-diagnosed stable COPD patients
* aged 40 to 80 years
* lived in Beijing for over one year before being recruited
* Agree to participate and sign the informed consent form.

Exclusion Criteria:

* Patients with a history of acute exacerbation in the last 1 month
* Patients with other respiratory diseases such as bronchiectasis and asthma.
Study to Assess the Efficacy of Cognitex

A Single-Center, Open Label Study to Assess the Efficacy of Cognitex in Elderly Subjects with Memory Impairment


Eligibility Criteria:
Inclusion Criteria:

1. Ability to give written informed consent.
2. Age: 90≥ years ≥60.
3. Gender: male and female.
4. Memory test performance within or below the mean established for adults in the computerized cognitive tool, with a maximum of four neuropsychological subtests scored 1.5 SD above the mean.
5. Language: Subjects must be able to read, write and speak Hebrew.
6. Ability to perform tests and interviews.

Exclusion Criteria:

1. Evidence of delirium, confusion, or other disturbances of consciousness.
2. Evidence of dementia.
3. Any Neurological disorder that could produce cognitive deterioration. Such disorders include Parkinson's disease, stroke, intracranial hemorrhage, local brain lesions including tumors and normal pressure hydrocephalus.
4. History of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies.
5. Head injury immediately preceding cognitive deterioration.
6. Evidence of depression as determined by a the Geriatric Depression Scale (short version) score of 5 or more.
7. Current diagnosis or history of alcoholism or drug dependence.
8. Any medical disorder that could produce cognitive deterioration including renal, respiratory, cardiac, and hepatic disease, diabetes mellitus, endocrine, metabolic or hematological disturbances unless well controlled, and malignancy not in remission for more than two years
9. Use of anti-clotting or antiplatelet medications or supplements for less than two years.
10. History of clotting or platelet disorder unless well controlled.
11. Use of any supplement that may significantly affect cognitive functioning during the month prior to study initiation.
12. Use of any experimental medication within 1 month prior to screening or as concomitant medications.
13. History of hypersensitivity or allergy to soy or fish.
Evaluating Atorvastatin With Omega-3 Fatty Acids in Cardiovascular Risk Reduction in Patients With Type 2 Diabetes

The AFORRD trial is asking three important questions:

What proportion of people with Type 2 Diabetes are likely to be treated satisfactorily with a fixed dose of a statin that lowers blood cholesterol levels to help reduce the risk of heart disease? To what extent do omega-3 fatty acids lower blood triglyceride levels when given with or without a statin? Are there simple techniques that can help people to take their tablets on a regular basis?


Eligibility Criteria:
Inclusion Criteria:

* They have a diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to entry.
* Are not known to have had a cardiovascular event

Exclusion Criteria:

* They are taking prescribed lipid lowering therapy
* Have triglycerides \> or = 8.0 mmol/L
Happy Baby Hearts Study

The goal of this observational study is to determine the feasibility of renal Near Infrared Spectroscopy (NIRS) monitoring in the newborn nursery for newborns at low risk of coarctation of the aorta (CoA). The main questions it aims to answer are:

* whether continuous renal NIRS monitoring is feasible;
* whether NIRS monitoring results in higher nursing and parent/caregiver satisfaction than current standard monitoring; and,
* whether participants who develop CoA will spend a smaller proportion of time within the normal range than patients who do not have CoA.

Participants will be observed through continuous renal oxygenation monitoring with NIRS.


Eligibility Criteria:
Neonate Inclusion Criteria:

* Delivered at ≥ 35 weeks of gestation
* \<12 hours of age
* Inpatient at Meriter Hospital, Inc. NICU or Newborn Nursery or AFCH PICU or NICU
* Diagnosed as at risk for CoA

Neonate Exclusion Criteria:

* Major congenital anomalies of the kidney
* Attending physician's discretion to not place sensors due to clinical concerns
* In the researcher's medical opinion, there is a significant likelihood that the neonate would not survive the first 3 days of life

Primary Caregiver Inclusion Criteria:

* Able to understand and the willing to sign a written informed consent document
* Willing to comply with all study procedures and be available for the duration of the study
* Birth parent (i.e., the parent who gave birth to the baby) who is the primary caregiver of a neonate who is eligible to participate in study
* Agrees to enroll neonate into study
* Aged 15 years or older
* Pregnant mother with a baby diagnosed prenatally as at risk for CoA will be eligible for the study. They must also meet the following criteria:
* Require an "arch watch care plan" as a results of prenatal ultrasonography findings
* Agree to enroll offspring into the study at birth

Primary Caregiver Exclusion Criteria:

* Subject is unable to provide informed consent, including subjects who are in foster care and subjects within state custody
* Pregnant woman who does not plan to maintain custody of the child after birth, such as instances of adoption or surrogacy

Newborn Nursery Nursing Staff:

* All Newborn Nursery nursing staff at Meriter Hospital, Inc.'s Newborn Nursery are eligible to participate