cyrilzakka/clinical-trials huggingface dataset:
Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event

The purpose of this study is to determine the effect of VIA-2291 as compared to placebo on vascular inflammation following 24 weeks of dosing.

The effect of VIA-2291 on vascular inflammation will be assessed through 18FDG PET vascular imaging measurements and various biomarkers after 24 weeks.

Eligibility Criteria:
Inclusion Criteria

* Female patients must be of non-childbearing potential
* Recent acute coronary syndrome \[(ACS) ST elevation myocardial infarction (STEMI), non-STEMI or unstable angina) event documented by ECG, cardiac enzymes or angiogram\] 1 - 3 months prior to randomization
* Carotid or ascending aorta artery plaque inflammation Target-to-Background Ratio (TBR) ≥ 1.6
* Receiving concomitant statin therapy following the qualifying ACS event for a minimum of 4 weeks, including a stable statin dose regimen for 2 weeks prior to randomization.

Exclusion Criteria

* Renal insufficiency defined as creatinine \>1.5 x upper limit of normal (ULN)
* Cirrhosis, recent hepatitis, alanine aminotransferase (ALT) \>1.5 x ULN (i.e., above the normal range) or positive screening test for hepatitis B (hepatitis B surface antigen) or hepatitis C (by ELISA)
* Type I diabetes and uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) \> 9%
* Heart failure defined by New York Heart Association Class III or IV
* Coronary Artery Bypass Surgery (CABG) within 4 months of randomization
* Use of zileuton, montelukast, coumadin or steroids
* Acetaminophen use in any form in the 7 days before enrollment at Visit 1
* Allergy to contrast agents
* Planned additional cardiac intervention (e.g., PCI, CABG) within next 6 months
* Current atrial fibrillation, atrial flutter or frequent premature ventricular contractions
A Community-health Worker Delivered HIV/STI Prevention Intervention for Internally Displaced Women in Leogane, Haiti

The investigators will develop, deliver and evaluate a solar powered tablet-based individual and group focused HIV/STI prevention intervention with internally displaced women in Leogane, Haiti. Internally displaced women will be trained as community health workers to deliver the HIV/STI prevention intervention to other internally displaced women.

We will develop and field test a multi-component intervention that includes (1) solar-powered tablets with brief video-based educational messages and (2) 6 weekly peer-group sessions. The tablet will be programmed to analyze the data and to indicate incorrect HIV knowledge responses so the community health worker can immediately provide correct responses. This intervention involves 6 weekly women's health meetings that will cover a variety of issues pertinent to women's sexual health: HIV/AIDS, sexually transmitted infections, interpersonal relationships, communication and decision making, mental health and coping, creating social change.

Eligibility Criteria:
Inclusion Criteria:

* 18 and over
* capable of providing informed consent
* internally displaced (living in tent or camp)
* female

Exclusion Criteria:

* male
* under 18 years old
* not able to provide informed consent
Cost-consequence Analysis of Parenchymal Stapling Device Versus Hand-sewing for Pulmonary Lobectomy in Lung Disease

The purpose of this study is to compare the efficacy and cost difference of using a parenchymal stapling device versus hand sewing for a pulmonary lobectomy in patients with lung disease (mass or others).

There are many lung diseases that need surgical treatment including malignancy lesion or benign lesions such as lung bleb or bullae, lung cyst, benign tumor, infection (necrotizing pneumonia, lung abscess, aspergilloma) etc. One of the most common procedure is pulmonary lobectomy. The surgical method for dividing parenchyma when performing lobectomy was divided in two methods. In the past, the investigators used hand-sewn technique but this procedure was time-consuming, high risk of air leakage, infection and re-operation, long length of hospital stay and high total cost of treatment. In the present time, the investigators use stapling device which has been used worldwide in various field of surgery since 1995. Many studies proved that using stapling devices can reduce post-operative complication, length of hospital stay and total cost of treatment and also became the standard instrument for lung surgery. In Thailand, these devices have been used for at least 5 years but they were not included in all of Health Insurance of Thai Government. Many patients had to pay for these devices by themselves, approximately 323-484.5 USD. Therefore, the investigators try to prove the hypothesis that using stapling devices for lung surgery would reduce the cost of treatment, post-operative air leakage, re-operative rate, length of hospital stay and time of surgery. The result of this study may effect the decision for including these devices in the Health Insurance of Thai Government.

Eligibility Criteria:
Inclusion Criteria:

* Patients who diagnosed lung diseases that need to perform pulmonary lobectomy

Exclusion Criteria:

* Patients have complete fissure. therefore, no procedure need to divide the lung parenchyma.
Knee Pain After Intramedullary Nailing in the Tibia

The primary objective of this study is to evaluate the long-term outcome after inserting an intramedullary nail in patients with a tibial shaft fracture using an injury-specific questionnaire.

Introduction

The treatment of choice for unstable diaphyseal fractures in the tibia is reamed insertion of an intramedullary nail (IMN) with the additional placement of interlocking screws. The most common complication after insertion of an IMN as treatment of tibial shaft fractures is chronic knee pain with reported rates between 10 % and 87 % with a mean of 47,4 % in metaanalyses.

Methods

The primary objective of this study is to evaluate the long-term outcome after inserting an IMN in patients with a tibial shaft fracture using an injury-specific questionnaire.

This study includes patients operated on five Danish hospitals. A database search was made using operational codes for insertion of an IMN in a five-year period. Patients aged 18 years or older, alive and residing in Denmark at the time of follow-up could be included in the study. These patients then received a Knee Injury and Osteoarthritis Score (KOOS) questionnaire by mail with questions regarding knee-specific symptoms, stiffness, pain, function and quality of life. Questionnaires were filled out and returned to the corresponding physician for further analyze. Patients who were unable to fill out the questionnaire due to concomitant physical condition or who had undergone amputation or further surgery on the affected limb were excluded.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older, alive and residing in Denmark at the time of follow-up could be included in the study.

Exclusion Criteria:

* Patients who were unable to fill out the questionnaire due to concomitant physical condition or who had undergone amputation or further surgery on the affected limb were excluded.
Health-related Quality of Life, Psychological Distress and Fatigue in Metastatic CRPC Patients Treated With Radium-223

The aim of the current prospective multicenter study is to evaluate cancer-specific and bone metastases related HR-QoL, psychological distress and fatigue in mCRPC patients before, during and after treatment with radium-223 in daily practice. Furthermore, the investigators aim to determine patient groups with identical health-related quality of life patterns over time, in order to identify variables related to health-related quality of life deterioration during the course of treatment, as patients with health-related quality of life deterioration may need specific attention to preserve health-related quality of life.

Radium-223 is a registered treatment option for patients with symptomatic bone metastatic castration-resistant prostate cancer. Previously, the phase 3 ALSYMPCA trial demonstrated that radium-223 improved overall survival and prolonged the time to the first symptomatic skeletal event and the time to first opioid use, irrespective of prior docetaxel chemotherapy. Subsequent analysis of the ALSYMPCA study showed that a significantly higher percentage of patients receiving radium-223 experienced meaningful HR-QoL improvement, as measured by the EQ-5D questionnaire and the FACT-P questionnaire, when compared to patients treated with placebo. However, studies evaluating health-related quality of life, psychological distress and fatigue in metastatic castration-resistant prostate cancer patients treated with radium-223 in daily practice are lacking.

Eligibility Criteria:
Inclusion criteria:

* Metastatic castration-resistant prostate cancer;
* Undergoing treatment with radium-223 according to standard of care;
* Ability to comply with the study protocol, including completion of questionnaires on health-related quality of life;
* Written informed consent to the treating physician at the hospital site.

Exclusion criteria:

* Prior radium-223 therapy;
* Impaired cognitive functioning and/or illiteracy.
Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with diffuse cutaneous systemic sclerosis.

Part A of the study is an interventional, double-blind, randomized, placebo-control design will be used to test safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in subjects ≥ 18 and ≤ 70 years of age with active diffuse cutaneous systemic sclerosis. The screening period is up to 28 days, with 84 days treatment period and 28 days follow-up off active treatment.

Part B of the study is an interventional, open-label design will be used. All subjects who complete dosing in Part A without permanent discontinuation of study drug and who pass repeat safety screening will be eligible for enrollment. The screening period is up to 28 days, with a 364 day treatment period and 28 day follow up after last dose of JBT-101.

Eligibility Criteria:
Inclusion Criteria:

Part A

* Diffuse cutaneous systemic sclerosis
* Have skin thickening from SSc in a body area suitable for repeat biopsy
* Disease duration ≤ 3 years from the first non-Raynaud's phenomenon or \>3 years and ≤ 6 years from the first non-Raynaud's phenomenon and high sensitivity C-reactive protein \> 3 mg/L, high sensitivity interleukin-6 \> 5 pg/mL, or increase in mRSS ≥ 5 points over the last 6 months with total RSS ≥ 12.
* Stable treatment for SSc for at least 28 days before Visit 1

Part B

•Completion of dosing in Part A without permanent discontinuation of study product because of safety or tolerability reasons.

Exclusion Criteria (Part A and B):

* Severe or unstable systemic sclerosis
* Significant diseases or conditions other than systemic sclerosis that may influence response to the study product or safety;
* Any one of the following values for laboratory tests at Screening:

  1. A positive pregnancy test (or at Visit 1);
  2. Hemoglobin \< 10 g/dL
  3. Neutrophils \< 1.0 x 10\^9/L
  4. Platelets \< 75 x 10\^9/L
  5. Creatinine clearance \< 50 ml/min according to modified Cockcroft-Gault equation
  6. Serum transaminases \> 2.0 x upper normal limit
  7. Total bilirubin ≥ 1.5 x upper limit of normal
* Any other condition that, in the opinion of the Principal Investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face

To compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of Acne Vulgaris


Eligibility Criteria:
Inclusion Criteria:

1. Signed IRB approved written informed consent/assent
2. 12 to 40 years of age, inclusive.
3. Clinical diagnosis of facial acne vulgaris with an inflammatory lesion (papules and pustules) count of 20-50, inclusive and a non-inflammatory (open and closed comedones) lesion count of 25-100 inclusive and no more than 2 nodulocystic lesions (e.g., nodules and cysts) including those present on the nose.
4. Baseline Investigator's Global Assessment Score of 3 (moderate) or 4 (severe) on a severity scale of 0 to 4.
5. Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.

Exclusion Criteria:

1. Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.
2. Presence of more than 2 facial Nodulocystic lesions.
3. Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations
4. Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments
5. Excessive facial hair that would interfere with the diagnosis or assessment of acne vulgaris.
6. History of unresponsiveness to topical adapalene and/or benzoyl peroxide therapy.
7. Currently using any product containing adapalene and/or benzoyl peroxide and/or belonging to the same family.
8. History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any ingredient in the study medication.
9. Use of medications known to exacerbate acne
10. Start or change within 3 months (90 days) of Visit 1 and throughout the study
11. Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study
12. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
13. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.
A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine

This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 61 years or above at the time of the first study visit (Day -30).
* Female subjects of non-childbearing potential.
* Healthy subjects or subjects with well controlled chronic medical condition (at the discretion of the investigator).
* Written informed consent obtained from the subject.
* Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

Exclusion Criteria:

* Previous administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ .
* Previous administration of the 2009 Southern Hemisphere or 2008-2009 Northern Hemisphere influenza vaccine.
* Previous administration of a pandemic influenza vaccine.
* Administration of licensed vaccines within 4 weeks prior to enrolment in this study.
* Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first study vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of chronic alcohol consumption and/or drug abuse.
* History of hypersensitivity to vaccines.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Acute disease and/or fever at the time of enrolment.
* Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination..
* Administration of immunoglobulins and/or any blood products within the three months preceding the first study vaccination or during the study.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to the first vaccination, or planned use during the study period.
* Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Diabetes Mellitus Community Based Screening in Minority Populations

The purpose of the type II diabetes (T2D) screening study is to improve diabetes care in minority communities by identifying undiagnosed and uncontrolled T2D patients, as well as help patients without a regular primary care physician (PCP) find one within their community. These goals will be achieved first through a glucose measurement. Individuals with a high glucose measurement will be confirmed with a rapid hemoglobin A1c (HgA1c) test. The HgA1c test will tell us about the patients average blood sugar over the past 3 months, which will allow us to immediately diagnose new and uncontrolled type II diabetics. All participants will fill out a survey on healthcare seeking behaviors before glucose testing. All patients who enter the study will receive education on T2D and the value of regularly visiting their PCP, and will be provided a list of PCP currently accepting new patients within a 3 mile radius. Follow-up visits at 4 and 8 months will help us determine the success this community based screening.

The investigators hypothesis is that community based screening designed with adequate education and follow-up, and performed by qualified medical professionals will improve diabetes care in minority communities as assessed through hemoglobin A1c levels over 8 months, and in the change in the number patients who visit/obtain their PCP within the study period.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 and older

Exclusion Criteria:

* Type I Diabetes.
* Women who are currently pregnant.
Effect of Covid-19 Pandemic in Non Covid-19 Patients at the Emergency Surgical Department

Introduction Most countries imposed mandatory lockdowns that were rapidly lifted, however Argentina holds the record for one of the longest quarantines in the world. General surgery emergency conditions and trauma cases still require immediate evaluation and timely resolution. The primary objective of this study was to analyze the variations in the consults, surgical outcomes and severity of disease in admissions at our department of general surgery and to study the consequences of the lockdown effect in our community.

Materials and methods An observational, ambispective study was carried out on a prospective cohort of patients who consulted with on-call surgical pathology and required hospitalization in the period from March 13th, 2020 until July 31, 2020 (PG) were included, analyzed and compared with the same period of 2019 (CG).

Participation in the study does not represent any additional risk for the included participants since participation in the protocol does not include any experimental intervention and the medical care and treatment of all participants that require it will be carried out according to the current guidelines. The protocol does not contemplate any procedure or study additional to the usual care of the patient.

Eligibility Criteria:
Inclusion Criteria:

* all non-Covid-19 patients over 18 years who consulted at the emergency surgical department of Hospital Italiano de Buenos Aires and required hospitalization in the period from March 13th, 2020 until July 31, 2020 (Pandemic Group-PG) and compared with the same period of 2019 (Control Group-CG).

Exclusion Criteria:

* None
Screening for Advanced Liver Fibrosis Using Non-invasive Tests in Primary Care

Liver fibrosis screening is possible at the asymptomatic stage through a healthcare management strategy currently recommended for patients with risk factors for chronic liver disease. It is based on a sequential strategy involving a 1st-line test, fibrosis score calculation (FIB-4).

Given this opportunity to identify advanced fibrosis in asymptomatic patients, the project aims to set up this screening program in the Grenoble area with Biogroup Laboratories, in collaboration with the Hepato-gastroenterology department (HGE) of Grenoble University Hospital. The aim of this study is to evaluate the success of sequential screening using FIB-4, followed by a specialized fibrosis test for the diagnosis of advanced hepatic fibrosis


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 70 years of age
* FIB-4 2.67
* Patients covered by Health Insurance System

Exclusion Criteria:

* Prescription triggering FIB-4 emanate from a hepatogastroenterologist or oncologist
* Conditions associated with high risk false-positive FIB-4: ASAT or ALAT \> 300 IU/L, platelets \<50 G/L or \>500 G/L.
* Patient refusing to participate
* Subjects under guardianship or deprived of liberty