cyrilzakka/clinical-trials huggingface dataset:
A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 \& 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 \& 3) or 48 weeks (genotype 1 \& 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody test
* Documented pre-treatment HCV RNA quantitative result
* Compensated liver disease (Child-Pugh Grade A)
* Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin)

Exclusion Criteria:

* Decompensated liver disease (Child-Pugh Class B or C cirrhosis)
* Co-infection with active hepatitis A and/or hepatitis B
* History or evidence of a medical condition associated with liver disease other than HCV
* Signs and symptoms of hepatocellular carcinoma
* History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease
* Therapy with antineoplastic treatment \</= 6 months prior to study day
* Diabetes mellitus in subjects receiving an insulin therapy
* Evidence of severe retinopathy
* Pregnant or breast-feeding women, and male partners of women who are pregnant
Maintaining Implementation Through Dynamic Adaptations (MIDAS) Suicide Prevention 2.0 Clinical Telehealth

Scientific advances are constantly leading to better treatments. However, it is quite challenging for healthcare systems, including VA, to ask very busy providers to change the way they practice. The MIDAS QUERI program helps providers improve the way they treat VA patients. This project will focus on increasing referrals to the Suicide Prevention 2.0 Clinical Telehealth (SP 2.0) initiative through the delivery of Academic Detailing and LEAP (a team-based quality improvement program). SP 2.0 provides accessible, evidence-based suicide prevention treatment to all Veterans with a history of suicidal self-directed violence or preparatory behaviors in the past 12 months.

Sustained integration of evidence-based practices (EBPs) is a challenge within many healthcare systems, especially in settings that have already strived but failed to achieve longer-term goals. The Veterans Affairs (VA) Maintaining Implementation through Dynamic Adaptations (MIDAS) Quality Enhancement Research Initiative (QUERI) program was funded as a series of trials to test multi-component implementation strategies to sustain optimal use of EBPs. The current project focuses on increasing referrals to the Suicide Prevention 2.0 Clinical Telehealth (SP 2.0) initiative.

The investigators have recruited 4 sites for this non-randomized intervention project. Sites have agreed to participate in pre-implementation interviews to gather information regarding barriers and facilitators to use of the SP 2.0 initiative. Sites will then be provided with tailored feedback regarding interview findings and potential use of Academic Detailing and LEAP to address these. Sites may then select to receive either Academic Detailing and/or LEAP which will be provided by MIDAS QUERI. Primary outcome will be rate of SP 2.0 referral adjusted for pre-intervention rate.

Eligibility Criteria:
Inclusion Criteria:

Note- the investigators are recruiting clinics/medical centers - not individual patients. Prior to implementation, the investigators will work with sites to ensure they have met the preconditions necessary to begin sustained optimization of the EBP:

* 1) a team leader or champion
* 2) an identified department with service leadership buy-in and control over the processes/practices impacted by the implementation
* 3) readily accessible data to measure process and impact of the implementation and use of the EBP
* 4) availability of required resources

Exclusion Criteria:

* N/A
Study of the Efficacy of Dienogest in the Treatment of Uterine Leiomyomas When Compared to Desogestrel and Goserelin

The investigators´aim is to assess whether the progestagen dienogest reduces leiomyoma volume and its associated symptoms to the same extent as gonadotropin releasing hormone (GnRH) analogs or the progestagen desogestrel or whether it is inferior to other drugs already in use.

Uterine leiomyoma is a very prevalent condition among women and, although it is mainly asymptomatic, it may be related to bothersome or debilitating symptoms, such as uterine bleeding and pelvic pain or pressure. The standard treatment is surgical (hysterectomy or myomectomy), but there has been continued interest on medical treatments. Progestagens have long been used to control bleeding associated to leiomyomas, but they have not been able to decrease myoma volume. GnRH analogs are well stablished agents, capable of controlling symptoms and decreasing the tumors´volume, but their use is limited by bone loss and menopausal symptoms. A newly introduced progestagen, dienogest, has been studied to treat endometriosis, but its effects on leiomyoma are only starting to be assessed. The investigators are aiming to compare dienogest with the GnRH analog goserelin and the progestagen desogestrel in a randomized trial to see how this new treatment compares with previously used drugs and whether it is similar, inferior or superior to them on controlling leiomyoma associated symptoms and decreasing leiomyoma volume.

Eligibility Criteria:
Inclusion Criteria:

* Women with 35 - 55 years of age
* Uterine volume between 50cc and 500cc
* Abnormal uterine bleeding probably associated to intramural uterine leiomyomas

Exclusion Criteria:

* Pregnancy
* Liver or kidney dysfunction
* Women with only submucosal or subserosal uterine leiomyomas
* Women with contraindications to any of the drugs (categories 3 and 4 of WHO eligibility criteria)
* Use of anticoagulants
* Others causes of abnormal uterine bleeding (endometrial pathology, cervical pathology)
Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer

The purpose of this research study is to find out what effects (good and bad) omeprazole and cabazitaxel, or omeprazole and docetaxel, has on participants and their condition. Investigators believe omeprazole may help the other medications work.

Primary Objective(s): Obtain Overall Response Rate (ORR) to taxane therapy by adding the fatty acid synthase inhibitor, omeprazole to the current "failing" taxane regimen in 15% of subjects using Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria, defined by partial response (PR) or complete response (CR)

Secondary Objectives (only at patients treated at Wake Forest Baptist Comprehensive Cancer Center main campus):

* Pharmacodynamics-demonstrate omeprazole in vivo fatty acid synthase inhibition by 11C-Acetate PET/CT (3-6) Non-invasive approach to demonstrate the fatty acid synthase inhibitor (omeprazole) is hitting its target
* Obtain a prostate specific antigen response rate by adding the fatty acid synthase inhibitor omeprazole to the current "failing" taxane regimen. (16)
* Measure pain using the Patient-Reported Outcomes Measurement Information System (PROMIS) at Baseline, Cycle 5, Cycle 12, and every cycle thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have castrate refractory prostate cancer with prior taxane treatment (docetaxel or cabazitaxel) which was used in the castrate refractory setting
* Cancer Progression as defined by PCWG3
* Age 18 or older.
* ECOG 0, 1, or 2
* Life expectancy of greater than 2 months
* Men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
* Organ \& marrow function as defined below: Absolute neutrophil count \>1,200/mcL Platelets \>75,000/mcL; total bilirubin= within normal institutional limits; AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal; creatinine \<2.5 X institutional upper limit of normal

Exclusion Criteria:

* Patients may not be receiving any other investigational agents.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to omeprazole or taxane therapy.
* 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.
Age, Traumatic Brain Injury and Injury Severity as Independent Risk Factors for In-Hospital Mortality in Polytrauma Patients.

In this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from January 2012 to December 2015. Patients with an ISS\>16 points, an AIS \>3 in one body region and at least 2 different body regions affected were included. Possible prognostic factors were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* ISS \>16 points
* AIS \>3 in one body region
* at least 2 body regions affected

Exclusion Criteria:

* patients younger than 18 years of age
* isolated traumatic brain injury
* minor injuries (AIS \<3 or ISS \<16 points)
Effects of Marine n-3 Fatty Acids on Heart Rate Variability and Arrhythmias in Patients Receiving Chronic Dialysis

Background: End Stage Renal Disease (ESRD) patients have an extremely high mortality and the leading cause of death is cardiovascular disease which accounts for 50% of all deaths. It is estimated that about one third is due to arrhythmias. Previous studies reveal a higher risk of various arrhythmias in dialysis patients but the prevalence is uncertain. Atrial fibrillation is the most common arrhythmia among patients with ESRD. The arrhythmia is often asymptomatic, but the risk of stroke increases dramatically and the annual mortality doubles. Autonomic cardiac dysfunction is often seen in patients with ESRD, and this is expressed by attenuated Heart Rate Variability (HRV) which is a measure of the variation in the time interval between heart beats. Attenuated 24 hours HRV is associated with an increased risk of sudden cardiac death in the general population and among patients with ESRD. N-3 polyunsaturated fatty acids (PUFAs) in fish or fish oil supplements have been shown to increase HRV and reduce the risk of various ventricular and supraventricular arrhythmias in some but not all studies, but this effect has only been sparsely investigated in the high risk patients with ESRD, who has a very low intake of n-3 PUFAs.

Objective: The purpose of this study is to investigate the effects of n-3 PUFA supplementation on HRV and arrhythmias in dialysis patients.

Hypothesis: n-3 PUFA supplementation increases 24 hours HRV in dialysis patients. n-3 PUFA supplementation reduces the level of Supraventricular tachycardia, premature atrial complexes (PACs) and premature ventricular complexes (PVCs) in chronic dialysis patients.

Design: Randomized double-blind, placebo controlled trial

Study participants: 140 dialysis patients at Aalborg University Hospital and Vendsyssel Hospital, Hjørring in Denmark.

Inclusion time: Summer 2014 to Fall 2015

Methods: The patients are allocated to 3 months treatment with supplements of 2 g n-3 PUFAs or placebo (olive oil). The following data are registered at baseline and after 3 months treatment: Demographics and medical history, Standard ECG-12, blood pressure, blood samples, 48 hours ambulatory ECG Holter recordings, Intake of n-3 PUFAs (assessed by questionnaires and blood measurements).

Perspective: A positive result of this study might make it possible to achieve a reduction in arrhythmias and mortality in these high risk patients by a cheap and well tolerated nutritional supplement.


Eligibility Criteria:
Inclusion Criteria:

* Dialysis \> 3 months
* Age \> 18 years
* Signed informed consent

Exclusion Criteria:

* Patients who is not able to consent.
* Known allergy to contents of the olive or fish oil capsules.
* Remaining life expectancy \< 3 months.
* Pregnancy (positive S-HCG) - test only performed in cases of doubt.
Translation, Validity, and Reliability of the Foot Posture Index (FPI-6) - Turkish Version

Individuals with foot-ankle problems (plantar fasciitis, metarsalgia, pes planus, pes planovalgus/varus) will be included in the study. Permission was obtained from the research group that developed the scale to use the Original Foot Posture Index-6 (FPI-6). Cross-cultural adaptation of the FPI-6 will be made in line with the guidelines published by Ruberto and Beaton. First of all, the FPI-6 will be translated into Turkish by two translators whose native language is Turkish and who can speak English at an advanced level. Translations will be compared and discussed, and a Turkish version will be obtained with the equivalents that best represent each item in the texts. Secondly, this retranslated text will be independently translated back into English by two native English translators. In the third stage, two texts written in English will be synthesized by the authors, thus reaching a consensus on a single translation. Finally, the inconsistent parts of the text will be checked by a multidisciplinary team consisting of two native English-speaking translators, members of the English language and literature department, authors who developed the scale, and physiotherapists. Two independent physiotherapists will evaluate the participants' foot posture indexes by FPI-6 for inter-rater reliability. In addition, patients' quality of life, foot functions, hindfoot profiles will be evaluated. For the calculation of validity between measurements, rater-1 will apply the FPI-6 again to the same participants after 15 days for intra-rater reliability. Patients' functional independence, activities of daily living, and quality of life will also be evaluated for criterion validity. American Orthopedic Foot and Ankle Society-AOFAS, SF-36 and Foot Function Index questionnaires will be applied for the validity of FPI-6.


Eligibility Criteria:
Inclusion Criteria:

* being between the ages of 18-65,
* having foot-ankle problems (plantar fasciitis, metatarsalgia, pes planus, pes planovalgus/varus, hallux valgus, pes cavus, pain)

Exclusion Criteria:

* Having undergone any lower extremity surgery in the last two years,
* patients with congenital foot deformity and neurological problems,
* Individuals with lower or upper extremity pathology or a cognitive problem that may prevent or limit the application of the test protocol
Home-Based Exergame Program for Community-Dwelling Older Adults

The purpose of this study was to investigate the effect of a home-based exergame program on physical function, fall efficacy, depression, and quality of life in older adults. For the purpose of the study, the investigators established the following hypotheses. Older adults who participate in a home-based exergame program will experience significant improvements in physical function, fall efficacy, depression, and quality of life compared to those who do not participate in the program.


Eligibility Criteria:
Inclusion Criteria:

* 75 years or older
* the ability to walk independently with or without a walking aid
* a mini-mental state examination score ≥ 24.

Exclusion Criteria:

* musculoskeletal disorders such as fractures or dislocations
* neurological impairment
* mental disorders
* uncontrolled endocrine, cardiovascular, or urinary system diseases
The Effect of E-Mobile and Written Education

Bening's Prostate Hyperplasia (BPH), which is closely related to aging, is one of the most common diseases in the world. Although it is not a life-threatening condition, lower urinary tract symptoms (LUTS) are seen in many patients, which disrupts their daily activities, sleep patterns, and quality of life of the patients. Examination of changes in sleep and quality of life after transurethral resection of the prostate (TUR-P) in patients with LUTS due to BPH and planning training according to their needs will positively affect the lives of these patients. It is very important for nurses to provide individual training and counseling by making use of innovative technology to ensure that patients manage the surgical process in a healthy way and cope with possible complications. This thesis study was planned as a three-group randomized controlled experimental study in order to determine the effect of e-mobile training and counseling on quality of life and sleep in patients who underwent TUR-P to manage the operative process and cope with possible complications.

This thesis study aims to determine the effect of e-mobile training and counseling on quality of life and sleep in patients who underwent TUR-P for BPH, to manage the operation process and to cope with possible complications, and to determine the effectiveness of the written training given to the patients, the control group and the e-mobile application designed for comparasion.

Eligibility Criteria:
Inclusion criteria:

- Being literate, not having communication, hearing and visual impairments, not having any psychiatric disorders, not having sleep apnea, using a smartphone for at least 1 year in the experimental group,

Exclusion Criteria:

-The patient's refusal to participate in the study
Comparison of Brivanib and Best Supportive Care (BSC) With Placebo and BSC for Treatment of Liver Cancer in Asian Patients Who Have Failed Sorafenib Treatment

The purpose of this study is to determine whether brivanib is an effective treatment for liver cancer in Asian patients who have failed or could not tolerate sorafenib therapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of advanced hepatocellular carcinoma
* Asian ethnicity
* Patient has failed ≥14 days of sorafenib treatment
* Cirrhotic status of Child-Pugh Class A or B with a score of 7
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2
* Life expectancy of at least 8 weeks
* Adequate hematologic, hepatic, and renal function

Key Exclusion Criteria:

* Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy
* Previous or concurrent cancer that is distinct in primary site
* History of active cardiac disease
* Thrombotic or embolic events within the past 6 months
* Inability to swallow tablets or untreated malabsorption syndrome
* History of HIV infection
* Prior use of systemic investigational agents for hepatocellular carcinoma (except sorafenib)
Evaluation of Sodium Fluorescein Use During Intraoperative Cystoscopy After Total Laparoscopic Hysterectomy

The primary objective is to describe the safety and efficacy of intravenous sodium fluorescein to visualize ureteral efflux during intraoperative cystoscopy after total laparoscopic hysterectomy. Secondary objective is to report on surgeon's satisfaction with the overall use of sodium fluorescein.

Thirty patients (n=30) ongoing a total laparoscopic hysterectomy in a tertiary gynecological reference center will be included in this prospective descriptive study.Once hysterectomy is completed, a 10 % solution of sodium fluorescein at a 0,25 ml dose will be injected before performing diagnostic cystoscopy. Time from injection to fluorescent visualization will be recorded as well as coloration density. Adverse events are collected in the operating room, in the recovery room, before patient's discharge and through a home survey.

Eligibility Criteria:
Inclusion Criteria:

* total laparoscopic hysterectomy

Exclusion Criteria:

* breastfeeding
* renal insufficiency
* Medication: Probenecid, digoxin, quinidine, beta-blocker
* hypersensitivity or intolerance to sodium fluorescein
Partners in Control, Phase II: Using Remote Monitoring Technology With Community Health Workers to Support Hypertension Management for Latinx Patients

This study seeks to evaluate the impact of a remote patient monitoring (RPM)-specific tech-enabled community health worker workforce on the use of RPM for the management of hypertension among Latinx patients. This study is a step-wedge randomized controlled trial that aims to assess the effectiveness and implementation of RPM-enabled community health workers (CHWs) compared to standard of care RPM hypertension management on blood pressure reduction and evaluate the implementation of the RPM-enabled CHWs for hypertension (HTN) management. The study aims to examine adoption, acceptability, fidelity, cost, sustainability, and equity as outcomes of implementation effectiveness.


Eligibility Criteria:
Inclusion Criteria:

1. Self-identify as Latinx
2. Be fluent in English or Spanish
3. Be age 18 years or older
4. Receiving care at one of the 10 safety-net primary care clinics
5. Have uncontrolled HTN documented in the electronic health record (EHR) on at least two visits in the past year (defined as an average BP ≥ 140/90 mmHg)
6. Have been prescribed at least one anti-hypertensive medication and be non-adherent to their medications, defined as adherence \<80% in the preceding 12 months, as determined by prescription orders obtained from the clinic EHR.

Exclusion Criteria:

1. Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks)
2. Participation in other hypertension-related clinical trials
3. Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR)
4. Plan to discontinue care at the clinic within the next 15 months
Pulse Oximeter Motion Study

Evaluate the performance of 4 pulse oximeters in 10 healthy adult volunteers with three motions compared to non-motion control at three arterial oxygen saturation target plateaus.

Evaluate the performance of 4 pulse oximeters (Masimo Radical-7, Nihon-Koden OxyPal Neo, Nellcor N-600, and Philips Intellivue MP5) in 10 healthy adult volunteers. Three motions will be evaluated: tapping, pseudorandom, and volunteer-generated rubbing, adjusted to produce photoplethsmogram disturbance similar to arterial pulsation amplitude. During motion, inspired gases will be adjusted to achieve stable target plateaus of arterial oxygen saturation (SaO2) at 75%, 88%, and 100%. Pulse oximeter readings (SpO2) will be compared with SaO2 from simultaneous arterial blood samples

Eligibility Criteria:
Inclusion Criteria: healthy adult English speaking -

Exclusion Criteria: pediatric, cardiac or pulmonary condition. non-english speaking

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