cyrilzakka/clinical-trials huggingface dataset:
Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers

This is a randomized trial of patients with gastrointestinal (GI) cancers treated at University of California, San Francisco (UCSF) who are starting a new line of systemic therapy to evaluate the feasibility of electronic patient reported outcome (ePRO) platform.

PRIMARY OBJECTIVES:

I. To evaluate the feasibility of the ePRO platform by describing the proportion of participants who engage with the ePRO tool via virtual care chat at least once after enrollment.

II. To investigate the potential differences in health-related quality of life (HRQoL) by comparing the change in overall score of EuroQol five-dimensional Questionnaire (EQ-5D) index.

SECONDARY OBJECTIVES:

I. To evaluate the degree of engagement with virtual care chat as defined by the proportion of chat modules completed.

II. To measure the potential differences in health-related quality of life (HRQoL).

III. To describe the symptom experience of participants in the intervention arm.

IV. To evaluate the performance of clinical escalation rules and impact on clinic workflow and efficiency.

V. To prospectively validate a risk model predicting emergency department (ED) visits and admissions due to cancer treatment side effects.

EXPLORATORY OBJECTIVES:

I. To compare unplanned ED visits and hospitalizations between intervention arm and control arm.

II. To compare referral patterns to Symptom Management Clinic. III. To compare concordance between participant self-reported and provider assigned Eastern Cooperative Oncology Group (ECOG) Performance Status.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Diagnosis of gastrointestinal cancers: esophageal, gastric, hepatocellular carcinoma, cholangiocarcinoma, pancreatic, neuroendocrine, small intestine, colorectal and anal cancers.
* Patients can have early stage or advanced cancer and will be starting treatment with new, standard of care infusion therapy regimen at UCSF.
* Ability to understand study procedures and to comply with them for the entire length of the study.
* No limit on prior lines of therapy.
* Access to smartphone, tablet, or computer with capability to use symptom tracking web site (must have mobile phone number or email address).
* Willing and able to provide written, signed informed consent in English.
* Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

* Patients who have already started therapy prior to study enrollment.
* Patients who are receiving their treatment outside of UCSF.
* Participation in another clinical trial (therapeutic or non-therapeutic).
* Patients who are on therapy with oral oncolytics or combination therapy of oral oncolytics and infusional agents.
* Patients who are non-English speakers.
Local Intraoperative Analgesic Injection Versus Single Injection Interscalene Nerve Block in Patients Undergoing TSA

A non-blinded randomized controlled trial, in which participants undergoing primary reverse or total shoulder arthroplasty are randomly assigned to one of two treatment groups.


Eligibility Criteria:
Inclusion Criteria:

1. All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Methodist Hospital or Rothman Specialty Hospital.

Exclusion Criteria:

1. Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia
2. Revision arthroplasty, arthroplasty for fracture
3. Unable/unwilling to consent for enrollment
4. Unable to complete postoperative pain survey
5. Known adverse drug reaction or allergy to the medications used
6. Chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic diffuse musculoskeletal pain)
7. Patients taking long acting narcotic pain medications (including extended release narcotic pain medications and methadone).
8. Patients under the age of 18 years
9. Patients with history of hepatic disease
10. Pregnant women or women who are breastfeeding
Outcome of GI Cancer in NCKUH

Alimentary tract cancer patients treated at National Cheng Kung University Hospital during 2013/01/01 to 2020/12/31 were reviewed.

We would like to explore the treatment strategy and clinical outcome of alimentary tract cancer in National Cheng Kung University Hospital. The result could help physician to further realize the real world practice of cancer treatment in Taiwan and might also help clinician to optimize the diagnosis and treatment strategy in alimentary tract cancer patients. Alimentary tract cancer patients treated at National Cheng Kung University Hospital during 2013/01/01 to 2020/12/31.

Eligibility Criteria:
Inclusion Criteria:

All patients with pancreatic cancer treated at National Cheng Kung University Hospital during 2013/01/01 to 2020/12/31

Exclusion Criteria:

No treatment or refuse treatment
A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB

A Long-Term Extension Study for Participants Previously Treated with EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

This is an open-label, long-term, follow-up study in participants from prior interventional trials involving surgical application of gene-corrected keratinocyte sheets (EB-101) for the treatment of RDEB wound sites. Up to 22 participants will be enrolled in this study, with follow-up through at least 5 years post treatment. Patient-reported outcomes and safety will be assessed throughout the study, and where applicable, compared to Baseline of the preceding interventional EB-101 trial. Upon completion, participants will transfer to an annual monitoring program for additional 10 years of phone visits.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give consent/assent;
* If under the age of 18, guardian(s) is/are willing and able to give consent;
* Prior study treatment with EB-101.

Exclusion Criteria:

* Inability to properly follow protocol as determined by the Principal Investigator
Clinical and Economic Impact of an Electronic Medical Record Interfaced Decision Support System for Minimizing Severe Drug-Drug Interactions

Leumit Health Services, an health maintenance organization operating in Israel, will incorporate a web-based, decision support system for handling drug-drug interactions and drug information, termed DDI+. the investigators hypothesize that implementing such a system will reduce health-care expenditures (e.g., hospital admissions, referrals to ERs, Imaging procedures).


Eligibility Criteria:
Inclusion Criteria:

* Number of chronic concomitant drugs ≥5

Exclusion Criteria:

* Patients diagnosed with HIV/AIDS, and/or viral hepatitis B or C.
Mailed FIT Outreach 2022

This project aims to evaluate different approaches to increase colorectal cancer screening among primary care patients at Penn Medicine through a centralized screening outreach program. In a pragmatic trial, we will evaluate different approaches to increase response rate to mailed fecal immunochemical test (FIT) kits among eligible patients, including differentiated packaging, sending text reminders, and personalized reminders.

While colonoscopy procedures are recommended by guidelines for early detection of colorectal cancer, colonoscopy access remains limited due to delays in screening due to the pandemic and capacity issues. In this project, we will evaluate different ways of reaching out to eligible patients to encourage them to participate in colorectal cancer screening using fecal immunochemical testing (FIT). In a mailed FIT outreach campaign, we will compare user friendly packaging, text messaging, and personalized reminders to standard outreach with the goal of increasing colorectal cancer screening uptake.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ages 50-74 with Penn as preferred lab
2. Followed by Primary Care with a participating Penn Medicine PCP listed and at least one visit in the last 2 years
3. Not up to date on colorectal cancer screening per Health Maintenance (no colonoscopy in the last 10 years, stool testing in the last year, flexible sigmoidoscopy in the last 5 years, FIT-DNA in the last 3 years).

Exclusion Criteria:

1. Personal or significant family history of CRC, colonic polyps, hereditary nonpolyposis colorectal cancer syndrome, familial adenomatous polyposis syndrome, other gastrointestinal cancer, gastrointestinal bleeding, iron-deficiency anemia, or inflammatory bowel disease
2. History of total colectomy, dementia or metastatic cancer
3. Currently on hospice or receiving palliative care
4. Uninsured or self-pay patients
5. Currently scheduled for a colonoscopy or sigmoidoscopy
Ovulation Induction in Clomiphene Citrate Resistant PCO Women

Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this study we will compare the effect of combined letrozole-metformin with that of combined letrozole-pioglitazone in ovulation induction in CC-resistant PCOS women

Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the ACOG recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS. CC has a long half-life (2 weeks), and this may have a negative effect on the cervical mucus and endometrium, leading to discrepancy between ovulation and conception rates. There has been a search for a compound capable of inducing ovulation but devoid of the adverse antiestrogenic effects of CC. recent studies have suggested that letrozole, an aromatase inhibitor, does not possess the adverse antiestrogenic effects of CC and is associated with higher pregnancy rates than CC treatment in patients with PCOS.

In this study the investigators shall compare the effect of combined letrozole-metformin with that of combined letrozole-metformin-pioglitazone in ovulation induction in CC-resistant PCOS women.This will be a prospective comparative clinical trial in which 2 groups of women will be generated (groups A and B) using the sealed envelopes randomization method.Group A (50 women) will receive: letrozole 2.5 mg/day from 3rd day of the cycle for 5 days and (pioglitazone 15 mg + metformin 850 mg) once daily from 1st day of the cycle for 10 days. Group B (50 women) will receive letrozole 2.5 mg/day from 3rd day of the cycle for 5 days and metformin 500 mg three times daily from continuously untill pregncy occurrs. Ovulation will be monitored by vaginal ultrasound and serum estrogen and progesterone.

Eligibility Criteria:
Inclusion Criteria:

* 20-40 years old
* PCOS infertile women resistant to CC for 3 cycles

Exclusion Criteria:

* Presence of medical disorders as diabetes, hypertension, cardiac problems, liver or kidney diseases, hyperprolactinemia or thyroid dysfunction
* Use of gonadotropins before
* Previous ovarian drilling
* Presence of urinary symptoms especially bloody urine
Ketogenic Diet for Traumatic Brain Injury

Traumatic Brain Injury is a major health concern in United States. There is a un-met need to develop new therapeutic options for faster neuron recovery without causing significant side effects. The role of ketones in neuronal recovery has been studied and has been found to be useful in decreasing size of contusion. The present study aims to study the safety and feasibility profile of ketogenic diet.

Traumatic Brain Injury (TBI) is a major health concern for United States contributing nearly one-third of injury-related deaths in United States. The Centers for Disease Control and Prevention (CDC) estimates that 1.7 million people in the United States sustain a TBI each year. It is responsible for significant disabilities and the total cost of productivity loss was estimated to be $76.5 billion in the United States in 2004.

Several animal models have demonstrated the effectiveness of ketones in brain injury to decrease the size of contusion, improving cortical ATP levels, reduced brain edema and cellular apoptosis. Ketones have been shown to be effective in neuromodulation in animal models. Evaluation of carbohydrate free diet has been done in traumatic brain injury patients and it was noted to not cause fluctuations in blood glucose. There is a need for safety and feasibility study of ketogenic diet in traumatic brain injury patients and to understand the effectiveness in neuromodulation in humans. The present study focuses on identifying the safety and feasibility of KD in traumatic brain injury patients.

This pilot project data will be utilized to design future randomized clinical trials. Based on the safety data, further trials will be conducted to evaluate the effectiveness of KD in traumatic brain injury patients and its effectiveness in controlling elevated intracranial pressure. It will open the avenue for consideration of new treatment option for intracranial pressure management and functional recovery. From a nutrition perspective, Ketogenic diet might become the standard of care for this patient population.

Eligibility Criteria:
Inclusion Criteria:

1. Severe Traumatic Brain Injury
2. GCS\<= 8 with severe head injury
3. Age more than 18years

Exclusion Criteria:

1. Diabetic Ketoacidosis
2. Unstable metabolic condition (persistent hyponatremia, hypernatremia, hypoglycemia, hypocalcemia, acidosis)
3. Cardiorespiratory or hemodynamic instability
4. Coagulopathy
5. Pancreatitis
6. Liver Failure
7. Severe hyperlipidemia
8. Inability to tolerate enteral feeds including ileus
9. Known Fatty acid oxidation disorder or pyruvate carboxylase deficiency
10. Any terminally ill patient with poor brain stem reflexes and mortality within 24h of admission.
11. Pregnant Females
Comparison of Dexmedetomidin and Remifentanil for the Effect on Airway Reflex and Hemodynamic Response During Emergence in Patients Undergoing Craniotomy

During recovery from general anesthesia the stimuli of endotracheal tube lead to the coughing, hypertension, tachycardia, which can cause a serious complication. Especially the postoperative course of patients emerging from general anesthesia after intracranial surgery is frequently complicated by the occurrence of hypertension and coughing event.

It has been demonstrated that opioid, intravenous or topical lidocaine administration can attenuate the coughing reflex. Administered the opioid before emergence, it is effective to prevent cough reflex but the recovery is delayed, it was difficult to predict emergence.

However, remifentanil is an opioid widely used because of rapid context-sensitive half-life, target-controled infusion method to adequately maintain the effect site concentration could help to predict the recovery time to the alert state from the general anesthesia. It is considered proper method of continuous infusion of remifentanil for reducing emergence cough.

Dexmedetomidine , a potent alpha adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and and catecholamine response to intubation and extubation. It is thus theologically appropriate for reducing airway and circulatory reflexes during emergence from anesthesia.

In this study, the investigators used bolus dexmedetomidine immediately before extubation, and compared the effects on coughing, hemodynamic response and recovery profile to a continuous infusion of remifentanil.


Eligibility Criteria:
Inclusion Criteria:

* SA I\~II, 2.aged between 20 and 70 year, 4.general anesthesia for craniectomy

Exclusion Criteria:

* signs of an anatomical or functional abnormality in upper airway
* URI or sore throat for recent 2 weeks
* Congestive heart failure, Sinus Bradycardia(\<50 BPM), Uncontrolled hypertension
* Chronic obstructive lung disease, bronchial asthma
Health and Quality of Life of ITMO University's Students, Faculty and Staff

This study assess various indicators of physical and mental health, quality of life, well-being and satisfaction among students, faculty and staff of ITMO University. Participants are invited to join the study via informational web-site. Several quality of life indicators are obtained via surveys and some blood samples are taken to assess health condition.

Students, faculty and staff from ITMO University are invited to participate in health examination on the campus. Surveys, such as EQ-5D-5L, K10+OHQ29, PSQI and others, assess different aspects of quality of life related to health. Also participants are asked to undergo several measurements by the interviewer (waist, hips, height, weight and others). Moreover blood samples are taken from the participants and lipidogram, cholesterol and glycohemoglobin are checked.

Eligibility Criteria:
Inclusion Criteria:

* student, faculty or staff from ITMO University
* participants, who signed informed consent and consent for data gathering
* participants, who signed consent to enroll in following surveys and health check-ups

Exclusion Criteria:

* participants younger than 16 years old
* participants with acute conditions distorting quality of life assessment
* participants, who did not sign informed consent and consent for data gathering - participants, who did not sign consent to enroll in following surveys and health check-ups
Study Examing The Effect of Grapefruit Juice On The Blood And Urine Samples of Study Drug And Its By Product And Safety

CP-945,598 is eliminated primarily by enzyme CYP3A. Grapefruit juice may affect the activity of CYP3A and alter the amount of CP-945,598 in the blood. This study will therefore compare the time course of drug concentrations in the body, safety and tolerability of CP-945,598 given with or without grapefruit juice in healthy obese/overweight subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female subjects between the ages of 18 and 55 years.
2. Body Mass Index (BMI) of 27 to 40 kg/m2.
3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria:

* Non-prescribed use of drugs of abuse/ recreational drugs;
* Recent treatment with experimental drugs or herbal experiments;
* EKG and blood pressure parameters falling outside of protocol-specified limits;
* History of regular alcohol or tobacco use exceeding protocol-specified limits; grapefruit juice intolerance.
Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women

The purpose of this study is to determine whether two brief counseling sessions reduce drinking and improve health outcomes in HIV-positive women who drink at heavy/hazardous levels. Also, the study seeks to compare hazardous drinking versus nonhazardous drinking women on a variety of alcohol, HIV and life quality outcome measures.

Heavy alcohol use negatively impacts HIV/AIDS in several important ways. It increases HIV-risk behaviors, impairs the immune system and accelerates HIV disease progression. Heavy alcohol use also interferes with HIV care compliance, including appointment attendance and medication adherence.

Women are particularly important targets for alcohol use interventions. The threshold for harmful alcohol effects is strikingly low in women, with two drinks per day placing women at risk for negative health consequences. Heavy/hazardous alcohol use is less likely to be detected in women receiving health services. Women may be less likely to seek and or engage in alcohol treatment services, making nontraditional care settings particularly important for reaching this population.

This proposal tests the utility of a brief alcohol intervention for HIV+ women delivered in a medical setting. Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content. In addition, a comparison group of nonhazardous drinking, HIV+ women will be recruited. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.

The investigators hypothesize that women who receive the brief intervention will report lower mean weekly alcohol consumption and fewer heavy drinking episodes than women in standard care. The investigators also predict that women who receive brief intervention will adhere to their HIV medications and keep their health care appointments more consistently, and have improved HIV-related health outcomes. Finally, the investigators hypothesize that nonhazardous drinkers will have fewer psychiatric symptoms and better quality of life than hazardous drinking women.

Comparison(s): Standard HIV care

Eligibility Criteria:
Inclusion Criteria:

* Heavy/hazardous drinking levels (i.e., consuming 8 or more drinks per week, or have reported at least two heavy drinking occasions \[4 or more drinks/drinking episode\] in the last six months, or score positively on the CAGE or T-ACE).
* HIV-positive
* Receiving HIV care in Johns Hopkins Hospital (JHH) Moore Clinic

Exclusion Criteria:

* Actively psychotic and other severe mental health symptoms
* Current enrollment in alcohol or drug treatment
* Current enrollment in Hopkins psychiatric services
* Pregnancy (because of the ethical concern of randomization to standard care)
Iron Therapy in Patients With End-Stage Renal Disease

This study will compare the clinical outcome of patients with maintenance dialysis room after changing the iron treatment guidelines from original upper limit with ferritin\>500ng/ml, or TSAT\>20% to Ferritin\> 800ng / ml, or TSAT\> 50%.

After two years of treatments, we will compare the incidence of clinical events, monthly blood, and biochemical examination data for the two years before and after the change.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving maintenance dialysis

Exclusion Criteria:

* less than 20 year-old, oncological patients undergoing chemotherapy, abnormal liver function, infection
Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation

The aim of this trial is to evaluate the safety and cost effectiveness of omission of percutaneous coronary intervention of significant coronary artery disease in patients scheduled to undergo transcatheter aortic valve implantation.


Eligibility Criteria:
Inclusion Criteria:

* Severe AoS meeting the criteria stated by the ESC in the ESC/EACTS Guidelines for the management of valvular heart disease AND considered symptomatic (NYHA functional class ≥ 2);
* TAVI decided by multidisciplinary Heart Team taken into account the international standards by ESC and guidelines of Dutch Society for Cardiology (NVVC);
* ≥ 1 stenosis in epicardial coronary artery (\> 2.5mm) or bypass graft. Stenosis is considered significant if angiographic 70-99% or angiographic 40-70% with positive hemodynamic parameters.
* Written informed consent.

Exclusion Criteria:

* Unprotected LM-stenosis or equivalent
* No PCI-eligible stenosis
* Contraindication for DAPT
* Life expectancy \< 1 year