cyrilzakka/clinical-trials huggingface dataset:
Alterations in Protein Synthesis Rates of Burn Patients Measured Over Time Using PET Scans

Our specific aim is to gain an understanding of protein synthesis rates in burn patients at various times during their injury and recovery by using PET scans. This will be compared with healthy volunteer controls. We hope this will help optimize nutrition and care regimens for future burn patients.

The purpose of this study is to understand how muscles are built up and broken down (metabolism) in both burn patients and healthy people.The studies will help us understand how muscle metabolism is different for burn patients and healthy subjects. We hope to find ways to help the body of a burn victim heal without losing too much muscle.

Protein is an important part of our daily diet. Normally, the body breaks down the protein we eat into smaller pieces called amino acids. It uses the amino acids to make its own proteins. It uses these proteins to heal wounds, fight infections, and provide energy.

After a burn injury, the body speeds up the pace of its life activities. It needs more energy just to stay alive and recover from the burn. The body often gets the extra energy it needs by breaking the protein in muscles down into amino acids. The amino acids are then made into new proteins. If too much muscle is broken down, it is harder for the body to function. This can make recovery slower or possibly lead to death.

For Healthy Volunteers, this study will require no more than 6 hours of time in total. This time will be spread out over two visits, a Screening Visit and a Scan Visit.

For Burn Patients, this study will require no more than 14 hours total. This time will be spread out over four visits-a screening visit and a maximum of 3 scan visits. A total of three PET scans will be done over a 2 year period.

Eligibility Criteria:
Inclusion Criteria:

FOR HEALTHY VOLUNTEERS

Healthy males and females 18-70 years of age.

Laboratory results within MGH-accepted normal range.

Within 20% of the ideal weight for their height.

Supine and standing blood pressure within the range of 110/60 to 150/90 mm Hg

Heart rate within the range of 46-90 beats/minute after 5 minutes of rest.

Subjects \<40 years old with HCT \>=24, age 40-60 with HCT \>=27, age 60-70 with HCT \>=30.

FOR BURN SUBJECTS:

Inclusion Criteria:

Burn Injury of \>=5 % TBSA from any cause.

18 -70 years of age

Stable hemodynamic and cardiopulmonary states as judged by the attending surgeons in the burn unit.

Patient who is capable of giving full informed consent.

Exclusion Criteria:

FOR HEALTHY SUBJECTS Clinical evidence of physical or mental disease.

Clinically significant abnormality of the laboratory tests.

Known drug or alcohol dependence.

History of drug allergy

Taking standard prescription drugs within two weeks or investigational drugs within four weeks prior to the PET scan

Diabetes mellitus and other metabolic endocrine disorders Pregnant or lactating

FOR BURN SUBJECTS:

Pregnant or lactating females
Functional Inspiratory Muscle Training in Patients Diagnosed With Hypertension

This study was planned to investigate the effectiveness of combined exercise training, that is, functional inspiratory muscle training, with breathing exercises to be applied with a portable, easy-to-use respiratory muscle strengthening device, on exercise capacity and peripheral muscle strength.

Forty-five Individuals will be randomly divided into three groups:

Functional IMT Group (n:15): will receive functional inspiratory muscle training (exercise + 50% of MIP) IMT Group I (n:15): will recieve inspiratory muscle training (50% of MIP ) Control group (n:15): will recieve breathing exercises training

Eligibility Criteria:
Inclusion Criteria:

1. Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg,
2. It will include both male and female subjects aged ≥18 and \<80 years with a previous diagnosis of essential hypertension.
3. Subjects receiving no pharmacological treatment or receiving only thiazide diuretics
4. Those with a body mass index \<30 kg/m2 Those who engage in \<150 minutes of moderate or intense physical activity per week, according to the 5th International Physical Activity Survey

Exclusion Criteria:

1. Blood pressure ≥160 / 100 mmHg
2. Severe dyspnea; diabetes; orthopedic, musculoskeletal, or fitness limitations;
3. Major physiological crises;
4. A current or past history of deep venous thrombosis; History of myocardial infarction or stroke within the 5th year or 6 months ago;

6. Congestive heart therapy; 7. Unstable angina; 8. or lung disease of any etiology (including asthma and chronic obstructive pulmonary disease); 9. Active smokers 10. Patients under 18 years of age 11. Pregnant women 12. Those with Active Infection 13. Those with Known Malignancy
Computed Radiography (CR) Data Collection for Mammography Computer Aided Detection (CAD)

The objective of this study is to collect an image library of diagnostic digital mammograms using the Carestream CR mammography system from patients who have histological-conformed breast cancer to demonstrate the clinical feasibility of this system for detection of breast cancer.


Eligibility Criteria:
Inclusion Requirements

* Women age 40 to 85
* Recommended for biopsy and BI-RADS assessment of category 4 (suspicious abnormality) or 5 (highly suggestive of malignancy)
* Able to have MLO and CC views taken
* Good general health
* Able and willing to provide a written Informed Consent

Exclusion Requirements

* Under age 40
* Pregnant or suspicious of being pregnant
* Breast implants
* Breasts too large to be adequately positioned on a 24 x 30 cassette
* Personal history of breast cancer treated with a lumpectomy
* Unable or unwilling to provide a written Informed Consent form
A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, people with ulcerative colitis or Crohn's disease will be treated with vedolizumab. The main aim of the study is to check for side effects from vedolizumab.

At the first visit, the study doctor will check who can take part. Participants will receive vedolizumab slowly through a vein (infusion). Participants will regularly visit the clinic for up to 46 weeks for more infusions of Vedolizumab. During these visits, the study doctor will check if there are any side effects from this treatment.

Participants will visit the clinic for a final check-up up to 16 weeks after their final infusion of Vedolizumab. Clinic staff will arrange a phone call 6 months after their final infusion of Vedolizumab for a further check-up.

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have active UC or CD.

The study will enroll approximately 150 patients. Participants will be assigned to the vedolizumab treatment group.

•Vedolizumab 300 mg

Vedolizumab 300 mg IV infusion will be administered once in Weeks 0, 2, 6 and 10 (CD-participants who have not shown a response can receive a dose at Week 10) during induction phase and in Weeks 14, 22, 30, 38 and 46 during maintenance phase.

This multicentre trial will be conducted in India. The overall time to participate in this study is 74 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone plus a final visit after receiving their last dose of drug for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Has a diagnosis of moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) at least 3 months prior to screening, with a Full Mayo Score of 6-12 for UC and a Harvey Bradshaw Index (HBI) score of \>=8 for CD at the time of enrolment.
2. Has demonstrated, an inadequate response to, loss of response to, or intolerance to at least 1 of the following agents:

   1. Conventional therapy
   2. TNF-α alpha antagonist

Exclusion Criteria:

1. Has undergone an ileostomy, colostomy, or has known fixed symptomatic stenosis of the intestine.
2. Has active or latent tuberculosis (TB).
3. Has had a prior exposure to vedolizumab or a history of hypersensitivity or allergies to vedolizumab, natalizumab, efalizumab, or rituximab.
4. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during screening or prior to the administration of study drug on Day 1.
Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL

The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages \>18
* Fasting triglyceride ≥500 mg/dL and ≤2000 mg/dL
* Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

* Women who are pregnant or lactating, or planning to become pregnant
* Use of non-statin lipid-altering drugs which cannot be stopped including fibrates, niacin, fish oil and other products containing omega-3 fatty acids or other dietary supplements with potential lipid-altering effects
* History of pancreatitis
* History of bariatric surgery or currently on weight loss drugs
* Uncontrolled hypertension (BP \> 160/100)
* HIV infection or on treatment with HIV-protease inhibitors, cyclophosphamide,or isotretinoin
* Consumption of more than 2 alcoholic beverages per day
* History of cancers (except if been disease free for \>5 years OR history was basal or squamous cell skin cancer)
* Participation in another clinical trial involving an investigational agent in the last 30 days
* Other parameters will be assessed at the study center to ensure eligibility for this study.
Dose and Response of Intrathecal Hydromorphone in Patients Undergoing Cesarean Section at Virginia Commonwealth University Health System

In the United States the incidence of cesarean deliveries have increased over the last several decades and is currently approximately 30% nationwide. The anesthesia and analgesia for elective c-sections vary between institutions.

Parturients present a unique challenge for the anesthesiologist as the mother has to care not only for herself, but also for the newborn postpartum. While intrathecal opioids provide adequate pain relief, they do so at the cost of bothersome side effects for patients, such as pruritus and nausea/vomiting.

Intrathecal hydromorphone has started to be explored as a new option for intrathecal analgesia. A study done by Beatty et al. showed in a retrospective review that 40 mcg of intrathecal dilaudid was safe and effective as compared to intrathecal morphine for analgesia after cesarean delivery. Additionally they showed no difference in side effect profiles of the two medications. Mhyre et al. investigated the use of 100 mcg of intrathecal dilaudid with hyperbaric bupivacaine in varying dosages for labor analgesia. The results were inconclusive, but the dosage of hydromorphone was reported to be without adverse effects.

Virginia Commonwealth University Health Systems has successfully instituted the use of intrathecal morphine with superior analgesia but with undesired side effects, most notably pruritus. Recent drug shortages of duramorph have prompted investigators to seek alternative options for post cesarean section analgesia. The investigators are interested in determining the dose, efficacy, and side effect profile of intrathecal hydromorphone. Although our institution has never utilized intrathecal hydromorphone for our patient population, it has been studied at various other institutions where it has been found to be safe and efficacious with an acceptable side effect profile.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status classification less than or equal to 3 Elective cesarean section Able to obtain a signed consent in English Patients who are 18 years or older

Exclusion Criteria:

* ASA greater than 3 or major medical comorbidities that are not optimized Patient refusal or contraindications to neuraxial/study drugs. Allergy to study drugs Conversion to general anesthesia Any patient who does not receive any multimodal regimen (PO acetaminophen, +/- PO ibuprofen/IV ketorolac) Any patient who is taking PO/IV opioids or buprenorphine during the current pregnancy
MD Ezetimibe Cyclosporine Interaction (0653-057)

Study to determine the effect of multiple oral doses of ezetimibe on the pharmacokinetics of a single oral dose cyclosporine in young healthy males and females.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female between 18 to 45 years of age
* Subject is judged to be in good health on the basis of history, physical examination, and routine laboratory data

Exclusion Criteria:

* Premenopausal women who are currently pregnant or who are currently nursing
* Subjects with drug or substance abuse, poor mental function, history of major gastrointestinal abnormalities (stomach issues), or high cholesterol
* Subject that has donated blood or has participated in another clinical trial within the last four weeks
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation.

Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.


Eligibility Criteria:
Inclusion Criteria:

1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
2. Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
3. Individual has an average systolic baseline home blood pressure ≥135 mmHg

Exclusion Criteria:

1. Individual lacks appropriate renal artery anatomy
2. Individual has undergone prior renal denervation
3. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
4. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
5. Individual has an estimated glomerular filtration rate (eGFR) of \<45
6. Individual has one or more episode(s) of orthostatic hypotension
7. Individual is pregnant, nursing or planning to become pregnant
8. Individual has primary pulmonary hypertension
9. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%
Effect of Night Float Call on Sleep and Activity Patterns Among Anesthesia Residents

With increasing awareness about physician fatigue and its effect on patient safety, residency programs are increasingly transitioning to a night float call system. In other industries, multiple night shifts in a row can cause a disruption in the circadian rhythm, sleep debt, shift work disorder, that is related to chronic medical conditions such as obesity and cardiovascular disease. We will evaluate the effect of different call structures on resident activity, sleep and self reported measures of wellness using a commercially available Fitbit device.

Participants will be recruited via an email once they are scheduled for a week of night float in the Stanford Main Operating room or on their Obstetric Anesthesia rotation. Potential participants who are taking prescription medications that might affect their alertness during the study period will not be enrolled.

The investigators will quantify the changes in sleep pattern and activity during different call rotations. Self reported aspects of well being including fatigue, physical function, and positive affect will be assessed with NIH PROMIS surveys periodically during the study period. The investigators will use the Fitbit Alta HR data to quantify the change in total amount of sleep, sleep interruption and sleep phase and steps per day. Data will be analyzed only when it is coincident with heart rate data to correct for periods when the device is not used.

Activity will not alter from the participants normal except that they will wear the Fitbit and respond to the NIH PROMIS surveys over the study period.

Data from NIH PROMIS surveys, Fitbit and provided demographic information including age, sex and BMI, and number of previous night float periods previously completed. After association, data will be completely de-identified.

All data will be normalized to the participant's baseline value during the run-in week. The call week and post call week will be analyzed with a time series mixed effects model using R and/or NONMEM (a program for Nonlinear Mixed Effects Modeling). The effects of the above demographic variables will be assessed as potential covariates.

The investigators anticipate that this observational study will be the first of many studies looking at the effects of changing sleep patterns on activity and well-being

Eligibility Criteria:
Inclusion Criteria:

* All residents (PGY2-5) who have been scheduled for either general operating room night float call or obstetric anesthesia rotation

Exclusion Criteria:

* Participants who report taking prescription medications that may effect alertness during the study period will not be enrolled.
Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers

This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers

Prospective, single center. Controlled study of a moisture retentive wound dressing and sustained compression with 6 weeks of 8 hour daily nitric oxide treatments.

Eligibility Criteria:
Inclusion Criteria:

* Must have a venous stasis ulcer between the knee and the ankle.
* Ulcer duration must be 60 days or greater

Exclusion Criteria:

* Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency
* Suffers from diabetes mellitus with HbA1c ≥ 8%
* Suffers from clinically significant arterial disease
* Is pregnant, a nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinent)

The above is a partial list of the inclusion and exclusion criteria; however, other inclusion and exclusion criteria may apply.
Study to Evaluate Efficacy and Safety of Bronpass Tab. in Patients With Chronic Obstructive Pulmonary Disease

This clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group dose-response phase 2 clinical trial study to evaluate the efficacy and safety of Bronpass Tab. in 96 patients with chronic obstructive pulmonary disease.

This study is to prove that Bronpass Tab. is superior in clinical efficacy and safety in improving COPD symptoms compared to placebo for 12 weeks in patients suffering from chronic obstructive pulmonary disease.

Eligibility Criteria:
Inclusion Criteria:

1. 40 years ≤ age
2. Patients who are diagnosed as COPD (based on the definition in the Korean Society of Tuberculosis and Respiratory Diseases COPD Guidelines)
3. Patients who meet all of the following criteria at the screening test

   * FEV1/FVC \< 0.70 after bronchodilator administration
   * 30% ≤ FEV1 \< 80% predicted after bronchodilator administration
   * Cough or sputum-related score on the CAT ≥ 3
4. Current or former smokers with a smoking history of 10 pack-years or more at screening.
5. Patients who have listened to a detailed explanation of this clinical trial, fully understand it, and voluntarily provide written consent to participate.

Exclusion Criteria:

1. Patients with a current medical history of asthma (However, patients previously diagnosed as asthma who have recovered and currently have a diagnosis of COPD are eligible for participation.)
2. Patients with a medical history of respiratory diseases other than COPD
3. Patients who have undergone lung volume reduction surgery.
4. Patients with a history of lung transplantation.
5. Patients with a history of respiratory infections within 4 weeks prior to screening
6. Patients with a history of moderate or severe acute exacerbation within 4 weeks prior to screening.
7. Pregnant or lactating women.
8. Patients who are considered ineligible for this clinical trial due to other reasons as judged by the investigator.
Vaccine Therapy in Treating Patients With Stage IIB, Stage III, or Stage IV Colorectal Cancer

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.

PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients with stage IIB, stage III, or stage IV colorectal cancer.

OBJECTIVES:

* Determine whether vaccination comprising HER-2-neu and carcinoembryonic antigen synthetic peptides, sargramostim (GM-CSF), and Montanide ISA-51 causes an immune response in patients with stage IIB, III, or IV colorectal cancer.
* Determine the safety of this regimen in these patients.

OUTLINE: Patients receive vaccination comprising HER-2-neu and carcinoembryonic antigen synthetic peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, and 15. On day 22, patients undergo removal of the lymph node into which the vaccination site drains to determine whether the immune system is responding to the vaccine.

PROJECTED ACCRUAL: A maximum of 15 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of colorectal cancer

  * Stage IIB, III, or IV disease
* HLA-A2- or -A3-positive

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count \> 1,000/mm\^3
* Hemoglobin \> 9 g/dL
* Platelet count \> 100,000/mm\^3

Hepatic

* Liver function tests ≤ 2.5 times upper limit of normal (ULN)

Renal

* Creatinine ≤ 1.5 times ULN

Cardiovascular

* No New York Heart Association class III or IV heart disease

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known or suspected allergies to any component of the study drug
* No active connective tissue disease requiring medications
* No systemic autoimmune disease with visceral involvement
* No uncontrolled diabetes
* No other severe autoimmune disease
* No medical contraindication or potential problem that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

* More than 30 days since prior immunotherapy
* More than 30 days since prior growth factors
* More than 30 days since prior allergy shots
* No prior vaccination with any study peptides for malignancy

Chemotherapy

* More than 30 days since prior chemotherapy

Endocrine therapy

* More than 30 days since prior steroids

Radiotherapy

* More than 30 days since prior radiotherapy

Surgery

* More than 30 days since prior surgery

Other

* At least 30 days, but ≤ 24 months, since prior therapy for colorectal cancer
* No concurrent illegal drug use