cyrilzakka/clinical-trials huggingface dataset:
Intradetrusor Triamcinolone Injection in the Management of Interstitial Cystitis/Bladder Pain Syndrome

This initial pilot project aims to study the use of FDA-approved 40mg triamcinolone injections in the bladder for the management of interstitial cystitis with or without Hunner's lesions. Intradetrusor triamcinolone injections are already the standard of care for IC patients with Hunner's lesions, but its role in management of IC without Hunner's lesions has yet to be determined. Triamcinolone is a long-acting corticosteroid that acts by inhibiting the migration of polymorphonuclear leukocytes, which may contribute to attenuation of inflammation in interstitial cystitis. We will recruit 27 females 18 years of age or older that have been diagnosed with IC/BPS. Patients will undergo a one-time cystoscopy along with the triamcinolone injections for IC management as a part of the research study. Validated questionnaires will be provided before the treatment to quantify symptoms at baseline and after treatment at follow-up visits. Follow up visits will occur in clinic every 4 to 6 weeks, which will continue for a maximum of 1 year. Scores at follow-up visits will be compared to baseline.


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet an appropriate diagnosis of IC from NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases)
* Patients must be female
* 18 years or older
* Have an official diagnosis of Interstitial Cystitis/Bladder Pain Syndrome

Exclusion Criteria:

* Patients who do not meet NIDDK inclusion criteria for Interstitial Cystitis as described above will not me enrolled in the study
* The presence of urinary tract or sexually transmitted infection (may be included once existing infection is treated and cleared)
* Pregnant women
* Patients who have the inability to consent on their own behalf
* Prisoners
Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections

This trial is a pilot study to determine the feasibility of a randomized clinical trial comparing a treatment algorithm consisting of a limited number of clinical parameters, rapid molecular viral diagnostics, and serum procalcitonin testing to standard of care for directing antibiotic use in patients with non-pneumonic lower respiratory tract infection. The reduction in antibiotic use in those subjects randomized to the treatment algorithm compared to those randomized to standard care will be determined.

This is trial is a pilot study to determine the feasibility of a randomized clinical trial comparing a treatment algorithm consisting of a limited number of clinical parameters, rapid molecular viral diagnostics, and serum procalcitonin testing to standard of care for directing antibiotic use in patients with non-pneumonic lower respiratory tract infection. The reduction in antibiotic use in those subjects randomized to the treatment algorithm compared to those randomized to standard care will be determined. In addition, the added benefit of viral diagnosis to that of serum procalcitonin alone in reducing antibiotics will be determined. Lastly, antibiotic related complications and clinical outcomes to determine the safety of this approach at 30 days and 3 months in the standard care and intervention group will be evaluated. Analysis of the composite adverse event outcome (death, intensive care unit transfer, disease specific complications and recurrent respiratory tract infection requiring hospitalization) will serve as the principle safety analysis for the study. In addition, each adverse outcome will be examined individually as well as lesser adverse outcomes including antibiotic prescriptions, time to return to baseline health, patient reported outcomes and functional status at 30 days and 3 months. Physicians will be queried to determine factors which drive antibiotic prescriptions and potential barriers to implementing antibiotic reduction algorithms. These data will be used to design a phase III clinical trial with the intent to demonstrate that physicians in the US will respond appropriately to this information and that antibiotic use can be significantly and safely curtailed.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized with symptoms of a respiratory infection
* Age \> 21 years
* Systolic Blood Pressure \> 90mm Hg
* Patient or health care designee can provide written informed consent

Exclusion Criteria:

* Intensive Care Requirement
* Antibiotics received prior to admission
* More than 24 hours of antibiotics received prior to enrollment
* Active chemotherapy or pulmonary radiation therapy
* Immunosuppressive conditions
* Conditions know to increase PCT values
* Definite infiltrate on CXR •% of band forms in peripheral blood \> 15
Bevacizumab (Avastin) Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence

This is a phase 1b study for safety and tolerability of bevacizumab(Avastin)administered into the tumor resection cavity in subjects with Glioblastoma Multiforme (GBM) at first recurrence.


Eligibility Criteria:
Inclusion Criteria:

1. Recurrent Glioblastoma
2. At least 12 weeks expected survival (KPS \>60)
3. 18 years of age or older
4. Able and willing to participate

Exclusion Criteria:

1. Any prior diagnosis of any other cancer or other concurrent malignancy.
2. Planned use or current use of other investigation therapy.
3. Systemic autoimmune disease
4. HIV positive
5. Concurrent life threatening disease
6. Impaired organ function
7. Active infection
8. Inadequately controlled hypertension
9. Congestive heart failure
10. Myocardial infection/unstable angina within 6 months
11. Stroke within 6 months
12. Pheripheral vascular disease
13. History of abdominal fistula/gastrointestinal performation
14. Non-healing wound
15. Coagulation disease
16. Known allergy to study treatments
17. Pregnant or lactating
Detection of Right Ventricular Dysfunction by 2D Strain During Acute Respiratory Distress Syndrom (ARDS)

Acute respiratory distress syndrome (ARDS) and mechanical ventilation can lead to right ventricular dysfunction and ultimately right ventricular failure by increasing pulmonary vascular resistances and pressure load. This can be prevented by modifying ventilator settings, using vasopressors or inotropes or even by prone positionning.But to do so, right ventricular dysfonction has to be detected. Echocardiography has emerged as a first line tool to diagnose right heart failure. Recently, strain analysis showed promising results to detect early right ventricle abnormalities in other settings such as pulmonary hypertension or scleroderma. We therefore decided to determine whether 2D strain could help detect early right ventricular dysfunction in ARDS.


Eligibility Criteria:
ARDS group

Inclusion Criteria:

* Need for mechanical ventilation
* ARDS criteria met: Respiratory failure not fully explained by cardiac failure, Pao2/FiO2\<200, bilateral opacities on Chest imaging, all symptoms appeared within 1 week

Exclusion Criteria:

* Predictable duration of mechanical ventilation shorter than 48 hours
* Contraindication to transesophageal echocardiography

ALI group:

Inclusion Criteria:

* Need for mechanical ventilation
* ALI criteria met: Respiratory failure not fully explained by cardiac failure, Pao2/FiO2\<300, bilateral opacities on Chest imaging, all symptoms appeared within 1 week

Exclusion Criteria:

* Predictable duration of mechanical ventilation shorter than 48 hours

Control Group:

Inclusion Criteria:

* Need for mechanical ventilation for a non-respiratory cause

Exclusion Criteria:

* Need for FiO2\>30%
* Known cardiac abnormalities
* Cardiac drugs intake during last 24 hours
Artificial Intelligence in Mammography-Based Breast Cancer Screening

Breast cancer (BC) is the most common cancer among women in worldwide and the second leading cause of cancer-related death.

As the corner stone of BC screening, mammography is recognized as one of useful imaging modalities to reduce BC mortality, by virtue of early detection of BC. However, mammography interpretation is inherently subjective assessment, and prone to overdiagnosis.

In recent years, artificial intelligence (AI)-Computer Aided Diagnosis (CAD) systems, characterized by embedded deep-learning algorithms, have entered into the field of BC screening as an aid for radiologist, with purpose to optimize conventional CAD system with weakness of hand-crafted features extraction. For now, stand-alone performance of novel AI-CAD tools have demonstrated promising accuracy and efficiency in BC diagnosis, largely attributed to utilization of convolution neural network(CNNs), and some of them have already achieved radiologist-like level. On the other hand, radiologists' performance on BC screening has shown to be enhanced, by leveraging AI-CAD system as decision support tool. As increasing implementation of commercial AI-CAD system, robust evaluation of its usefulness and cost-effectiveness in clinical circumstances should be undertaken in scenarios mimicking real life before broad adoption, like other emerging and promising technologies. This requires to validate AI-CAD systems in BC screening on multiple, diverse and representative datasets and also to estimate the interface between reader and system. This proposed study seeks to investigate the breast cancer diagnostic performance of AI-CAD system used for reading mammograms. In this work, we will employ a commercially available AI-CAD tool based on deep-learning algorithms (IBM Watson Imaging AI Solution) to identify and characterize the suspicious breast lesions on mammograms. The potential cancer lesions can be labeled and their mammographic features and malignancy probability will be automatically reported. After AI post-processing, we shall further carry out statistical analysis to determine the accuracy of AI-CAD system for BC risk prediction.


Eligibility Criteria:
Inclusion Criteria:

* Women who had undergone standard mammography including craniocaudal (CC) and mediolateral oblique (MLO) views..
* Histopathology-proven diagnosis is available for patients with breast malignancy, including invasive breast cancer, carcinoma in situ, and borderline lesion et al.
* As reference standard of benign nature, results from pathology or clinical long-term follow-up (\>=2 years) examinations are available for cases without breast malignancy.

Exclusion Criteria:

* Patients with concurring lesions on mammograms that may influence subsequent AI post-process.
* Patients without available pathologic diagnosis or long-term follow-up (\>=2 years) examinations.
* Patients who had undergone breast surgical intervention (e.g. lumpectomy and mammoplasty) prior to first mammography.
* Patients diagnosed with other kinds of malignancy, concurrent with metastasis or infiltration/invasion to breast.
Use of Intravitreal Triamcinolone and Retrobulbar Chlorpromazine as Alternatives to the Management of Painful Blind Eye

The purpose of this study is to evaluate the efficacy of intravitreal triamcinolone and retrobulbar chlorpromazine as alternatives in the management of ocular pain in blind eyes.

The management of chronic eye pain is a constant challenge to ophthalmology. Treatment varies with the intensity of pain, and topical eye drops and contact lens therapy are effective in many patients. In refractory cases, and without vision, surgical removal of the eye through enucleation is considered classical therapy. As less invasive alternatives we have cyclodestruction and neurolytic drug injection in order to promote analgesia for a prolonged period.

The purpose of this study is to evaluate the efficacy of intravitreal triamcinolone and retrobulbar chlorpromazine as alternatives in the management of This is a prospective study of patients with blind painful eyes not responsive to topical treatment and with no indication for evisceration seen at the Department of Ophthalmology, Hospital Governador Celso Ramos (HGCR) in 2010.

Eligibility Criteria:
Inclusion Criteria:

* patients treated in the period at HGCR who wanted to be part of the protocol by signing the consent form

Exclusion Criteria:

* patients whose follow-up period was less than three months
Comparing Perioperative Outcomes in Pain Control

This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an orthopaedic injury requiring surgery. Patients who consent to study participation will be randomized to receive either the multimodal pain management protocol or standard oral hydrocodone-acetaminophen for post-operative pain management. Data on opioid usage, pain control, and functional status will be collected for each participant. After 3 years of data collection, investigators will analyze this data to provide further insight in determining appropriateness of pain regimens that reduce the overall opioid consumption. Given the widespread opioid epidemic, it is imperative to develop alternative means to appropriately manage pain in orthopaedic surgery patients.


Eligibility Criteria:
Inclusion Criteria:

* Orthopaedic injury requiring surgery
* Evaluation and treatment at UCSD
* Age 18years or older
* Ability to understand the content of the patient information/Informed Consent Form
* Signed and dated Institutional Review Board (IRB) approved written informed consent

Exclusion Criteria:

* Polytrauma
* Any not medically managed severe systemic disease
* Their doctor has decided that it is in the patient's best interest to receive pain management regimen of one type vs. the other.
* The patient prefers one type of pain management protocol and is not willing to be randomized.
* Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment or confound pain control
* Pregnancy or women planning to conceive within the subject participation period (1 year)

  o Pregnancy will be self-reported and no test will be performed to test for it.
* Prisoner
* Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study.
Culprit-first in Primary Percutaneous Coronary Intervention

The aim of this study is to assess the impact of culprit-first versus culprit-last percutaneous coronary intervention on the door to balloon time and clinical outcomes in patients with ST-elevation myocardial infarction.

Ischemic heart disease (IHD) is the single most common cause of death and its frequency is increasing globally. It is estimated that IHD is the cause of 1.8 million deaths or 20% of all deaths in Europe. Despite advancements in the fields of rapid diagnosis and in treatment strategies, the morbidity, and mortality in patients with ST-segment myocardial infarction remains substantial, with an estimated mortality rate of 4-12% according to registries of the ESC countries. According to the 2017 European Society of Cardiology (ESC) guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation (STEMI), there is a level 1 recommendation with a level of evidence A for primary percutaneous coronary intervention (PPCI) strategy in patients with STEMI, and this strategy is preferred over fibrinolytic therapy. In addition, the ESC guidelines recommend a first medical contact to reperfusion time within 60 minutes in STEMI patients for primary PCI-capable centers. This recommendation is supported by a recently published study that showed shortening door to balloon (D2B) time was significantly associated with survival benefit. Based on the recommendation for maximal D2B time in STEMI patients to be 60 minutes, many countries and institutions worldwide have established programs, among them the national program for quality indicators by the Israeli ministry of health, to shorten D2B times. According to data published by the Israeli ministry of health in the year 2018, 88% of STEMI patients had a D2B time of \<90 minutes. The common practice during PPCI is to complete diagnostic angiography of the whole coronary tree before performing culprit-vessel revascularization. This practice is not evidence-based and current guidelines do not prioritize full diagnostic angiography over culprit-vessel revascularization first. As was found in previous studies, this practice might result in delaying revascularization by 4-8 minutes in D2B time. This delay might potentially lead to worse outcomes in STEMI patients, although not proven in the above-cited studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with STEMI who are eligible for PPCI

Exclusion Criteria:

* Cardiac arrest
* Cardiopulmonary resuscitation or extracorporeal membrane oxygenation on arrival to the catheterization laboratory
* Prior coronary artery bypass grafting surgery
A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy

The purpose of this study is to evaluate the effectiveness and safety of recombinant human erythropoietin in anemic cancer patients undergoing chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Cancer patients

Exclusion Criteria:

* a history of myocardial, cerebral or pulmonary infarction
* severe hypertension beyond control by drugs
Administration of GV1001 for the Treatment of Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011

The study will be conducted by the Sponsor to evaluate Twelve-months Long-Term Safety and Efficacy of GV1001 (1.12 mg) administered subcutaneously as a treatment for Progressive Supranuclear Palsy(PSP). In 75 patients diagnosed with PSP Richardson(PSP-RS) or PSP-Parkinsonism (PSP-P) who Completed Study GV1001-PSP-CL2-011.

In GV1001-PSP-CL2-011 study, subjects who were in the trial group (Study Group 1(GV1001 0.56 mg/day), Study Group 2(GV1001 1.12 mg/day) is alternately administered High-dose test drug(GV1001 1.12 mg/day) and placebo once a week from Ex-Visit 1(Visit 16, Week 26) to Ex-Visit 5(Visit 20, Week 30) and High-dose test drugs(GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks.

In the GV1001-PSP-CL2-011 study, subjects who were in the placebo group are administered placebo at Ex-Visit 1 (Visit16, Week26), the first visit of the extension study, and Ex-Visit 2 (Visit17, Week27) to Ex-Visit 5 (Visit 20, Week 30), High-dose test drugs(GV1001 1.12 mg/day) are administered once a week and High-dose test drugs (GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks.

Eligibility Criteria:
Inclusion Criteria:

* A person who has been registered in the GV1001-PSP-CL2-011 clinical trial and has completed administration by Week 24
* A patient who accompanied all visits with the subject for the scheduled visit of this clinical trial, has a guardian who can supervise the subject's compliance with the examination and examination procedures conducted at the time of the visit, and provides information on the subject's indications, and whose guardian has agreed in writing to participate in the clinical trial (except where it is unnecessary to accompany the guardian at the discretion of the investigator)
* Patient and/or representative of the patient who has voluntarily agreed in writing to participate in this clinical trial

Exclusion Criteria:

* Patients deemed unsuitable by the investigator to participate in this extension study
* Pregnant or male subjects who do not consent to contraception by medically approved methods (surgical infertility, intrauterine contraceptive devices, fallopian tube ligature, double blocking (combined use of male condoms, female condoms, cervical caps, contraceptive diaphragm and sponges) and 90 days after clinical trial participation However, women who have undergone menopause or surgical infertility procedures (such as vasectomy and difficult conception on both sides) before participating in clinical trials can participate without consent to contraception.
* Pregnant women or breastfeeding women
Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng

Will a unique form of ginseng be clinically helpful in those with chronic fatigue syndrome and fibromyalgia?

Ginseng has been shown in earlier studies to help fatigue in a number of conditions. But because of overharvesting, most ginseng is no longer have optimal levels of the active ginsenosides. A new technique has been developed to restore the level of active ginseng components those found in the wild ginseng used in earlier studies. This is available in a form called HRG 80 Red Ginseng.

The study is an open pilot study to explore whether this treatment would be helpful for improving clinical function and symptomatology in chronic fatigue syndrome and fibromyalgia. Current clinical experience is suggesting that it may be.

Eligibility Criteria:
Inclusion Criteria:

1. be diagnosed with CFS and/or fibromyalgia
2. live in the United States 3 - be over 18 years of age

Exclusion Criteria:

* Pregnancy
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in patients with ATTR amyloidosis with cardiomyopathy.


Eligibility Criteria:
Inclusion Criteria:

* Has a documented diagnosis of transthyretin (ATTR) amyloidosis with cardiomyopathy, classified as either hereditary ATTR (hATTR) amyloidosis with cardiomyopathy or wild-type ATTR (wtATTR) amyloidosis with cardiomyopathy meeting pre-specified diagnostic criteria
* Has medical history of heart failure (HF) with at least 1 prior hospitalization for HF OR clinical evidence of HF

Exclusion Criteria:

* Has known primary amyloidosis or leptomeningeal amyloidosis
* Has New York Heart Association (NYHA) Class IV heart failure
* Has NYHA Class III heart failure AND is at high risk based on pre-specified criteria
* Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV at the Screening visit
* Has estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m\^2
* Has received prior TTR-lowering treatment
* Has other non-TTR cardiomyopathy, hypertensive cardiomyopathy, cardiomyopathy due to valvular heart disease, or cardiomyopathy due to ischemic heart disease
Hydroxyurea in Primary Progressive Multiple Sclerosis

The pathogenesis of MS remain elusive, however some studies have linked the disease with infection by Epstein-Barr virus; therefore the use of drugs with immunosuppressive or immunomodulating action alone may be less suitable for primary progressive MS.This study will evaluate treatment with hydroxyurea (HU) in primary progressive MS. Hydroxyurea act by inhibiting the synthesis of deoxynucleotides essential for viral transcription,HU has recently been used in combination with antiretroviral drugs in HIV and has been shown to limit immune activation and suppress viral load by both antiviral and cytostatic activities. Furthermore has been demonstrated experimentally that HU suppressed the expression of EBV. For these reasons HU could be useful in primary progressive MS with cytostatic and antiviral action , confirming the role of EBV in the pathogenesis of MS.


Eligibility Criteria:
Inclusion Criteria:

* sign written informed consent
* 18 to 60 years of age inclusive
* diagnosis of PP-MS according to McDonald criteria
* EDSS score at screening of 2-7 inclusive

Exclusion Criteria:

* hypersensitivity to hydroxyurea
* patients who were treated with immunosuppressive drugs or steroid three month before
* respiratory or urinary infections
* history or presence of malignancy
* pregnancy or lactation
* low compliance to the therapy