cyrilzakka/clinical-trials huggingface dataset:
Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage

Patients may evolve pseudocysts of the pancreas secondary to a severe pancreatitis. In case of a symptomatic or infected pseudocyst, a therapeutic drainage of the cyst is indicated. In modern medicine the preferred way to perform such a drainage is by the means of endoscopic ultrasound (EUS). It is not precisely elucidated how this EUS-procedure should be performed in different scenarios. The cyst appearance and the drainage stents and/or technique may impact the clinical outcome.

This study is a prospective, single-center observational study on the outcome after EUS-guided drainage of pancreatic pseudocysts.

Patintes referred to Sahlgrenska University hospital for an EUS-guided drainage of a pseudocyst are eligible for inclusion. The drainage is performed at the discretion of an experienced endosonographer. Thus, the equipment and the technique used may vary among patients but no randomization is done before the procedure. Intraprocedural variables are registered as well as data and outcome parameters from the clinical follow up according to below.

Eligibility Criteria:
Inclusion Criteria:

* All patients \>18 years referred to the Sahlgrenska University hospital for the performance of an EUS-guided pancreatic pseudocyst drainage

Exclusion Criteria:

* Patients unwilling to participate or unable to understand or sign the informed consent
* Patients with no need for pseudocyst drainage as assessed by the endosonographer
Quince Seed Jelly and Breast Milk on Nipple Fissures

Background: In various experimental or clinical studies, it has been reported that the jelly made from the quince seed is effective in healing wounds (attributed to the antioxidants, which increased fibroblast activity and collagen production, facilitated the formation of granulation tissue and increased blood circulation) and has no side effects or contraindications.

Purpose: To evaluates the effects of quince seed jelly and breast milk on nipple fissures.

Methods: Randomised controlled experimental study.


Eligibility Criteria:
Inclusion Criteria:

* primiparity,
* those having no nipple problems and allergy history
* volunteered to participate in the study

Exclusion Criteria:

* nipple problems and allergy history
* multiparity
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Buccal Screening Evaluation Using an RT-PCR Assay and a Rapid ELISA Test Among Symptomatic and Asymptomatic Patients

The main objective is to expand screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by evaluating the diagnostic accuracy of the RT-PCR test (Cobas® Roche, Switzerland) and the ELISA Point of Contact Testing (PORTABLE COVID-19 ANTIGEN LAB® Stark, Italy) on buccal swab compared to the reference test, the RT-PCR test (Cobas® Roche, Switzerland) on nasopharyngeal swab.

Secondary objectives

* To evaluate the diagnostic accuracy of oral swab RT-PCR and POCT relative to the quantitative amplification (Ct) values of the NP Swab RT-PCR assay.
* Analyze RT-PCR amplification cycle thresholds (Ct) and POCT diagnostic accuracy as a function of the presence and timing of symptoms.
* Among symptomatic participants, compare clinical presentations between positive and negative participants on the NP swab RT-PCR test.
* The RT-PCR test may be imperfectly sensitive, ranging from 71 to 98%3. Using a Bayesian latent class model, the investigators will assess the true accuracy of POCT as it does not require the assumption that any one test or combination of tests is perfect14,15.


Eligibility Criteria:
Inclusion Criteria:

* 18+ patient eligible for COVID-19 testing in Monaco
* symptoms suggestive of COVID-19
* contact with a confirmed case of COVID-19

Exclusion Criteria:

* refusal to participate in the study
* preventive screening of professional groups
* inability to return to the screening center within 48-72 hours of the first visit.
A Case Control Study to Investigate the Possible Association Between Atrial Fibrillation and Endothelium Dysfunction by Using Flow-Mediated Vasodilation Method

Endothelial function is closely related to the hemostasis , vascular tone, and organ perfusion in cardiovascular system, and its dysfunction would cause overactivation of the coagulative system to induce thrombus formation. So we study the relationship between the endothelial function and atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Lone AF patients and normal controls

Exclusion Criteria:

* DM, hypertension, hyperlipidemia, smoking, pregnancy,
To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers

An open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and nebivolol or Paroxetine in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male adults aged ≥ 20 and ≤ 55 years at screening
* Subjects who voluntarily decided to participate in the study and provided written consent to follow study compliance requirements after receiving a detailed explanation on this study and fully understanding the information

Exclusion Criteria:

* Subjects unable to have the standard meal provided at the study site
* Subjects who took (the day of taking the last dose) another investigational or bioequivalence study product within 180 days prior to the first dose
Effect of DNS Exercises Training on Hypertension

Purpose of the study This study will be conducted to investigate any significant effect of dynamic neuromuscular stabilization training on postural control in patients with essential hypertension.

PURPOSE:

This study will be conducted to investigate any significant effect of dynamic neuromuscular stabilization training on postural control in patients with essential hypertension.

BACKGROUND:

The most recent global estimates suggested that hypertension (HTN) affected 1.13 billion people worldwide.

Raised blood pressure (BP) has emerged as the most important risk factor for global morbidity and mortality.

Hypertensive individuals present slower processing speed, reduced static and dynamic balance, decreased functional mobility during both single and dual tasking and higher fear of falling in comparison to normotensive individuals. These findings expand the body of knowledge about the effects of HTN on physical functions like prolonged processing time, disturbed balance and reduced mobility functions, which may guide clinicians in including preventive and rehabilitative strategies to their therapy protocols in order to improve the quality of life of the individuals with HTN.

HYPOTHESES:

Null Hypothesis: there will be no significant effect of dynamic neuromuscular stabilization training on postural control in patients with essential hypertension.

RESEARCH QUESTION: Will be any significant effect of dynamic neuromuscular stabilization training on postural control in patients with essential hypertension?

Eligibility Criteria:
Inclusion Criteria:

1. Sixty men patients with stage two essential HTN (more than 140/90 mm hg).
2. Their age will be ranged from 50-60 years old.
3. Body mass index (BMI) from 25 to 34.9 kg/m2.
4. Low levels of physical activity (using the International Physical Activity Questionnaire-Short Version) (The Arabic version of the questionnaire will be used)

Exclusion Criteria:

1. Uncontrolled HTN.
2. Diabetes mellitus.
3. Heavy Smoker.
4. Neurological or musculoskeletal conditions that interfere with gait
5. Vertebrobasilar insufficiency (VBI).
6. Use of psychotropic drugs.
7. Impaired vision and/or hearing.
8. Unstable medical conditions.
9. Patients who are unable to follow verbal instructions.
10. Participation in regular exercise training of any type in the previous 3 months.
Combination Treatment for Moderate to Severe Acne

To determine if a combination of three currently approved acne products are safe and effective for the treatment of moderate to severe acne

A Phase IV, Open-Label Study Evaluating the treatment for Combination Acne Therapy.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe acne, IGA = 3 or 4 (Investigator Global Assessment)

Exclusion Criteria:

* pregnancy and allergies
Cataract DME - Peri vs. Intraop

Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.

Along with age, diabetes is a major risk factor for cataract formation, which can lead to significant vision loss and disability without medical intervention. Unfortunately, diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. Reasons for this is multifactorial but includes an increased risk in the development of post-operative cystoid macular edema, and exacerbation of baseline DME. This poses a significant challenge in managing concomitant DME and visually-significant cataracts.

Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adults over age 18 with diabetes mellitus, diabetic macular edema and visually significant cataracts planning to undergo cataract surgery

Exclusion Criteria:

* Patients who have undergone panretinal photocoagulation (PRP) in prior 4 months or an ocular condition (other than cataract and DME) that might affect visual acuity during course of study.
* Patients with history of vitrectomy.
* Patients with neovascular glaucoma.
Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke

An open-label, blinded endpoint, randomized controlled trial that includes patients diagnosed with non-disabling, non-large vessel occlusion, acute minor stroke within 4.5 hours of onset. Eligible participants would be randomly assigned to the thrombolysis group (intravenous alteplase) and the dual antiplatelet group (oral aspirin plus clopidogrel). The primary outcome is the proportion of the excellent functional outcome (modified Rankin scale 0-1) at 90 days.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 40-80 years.
2. Diagnosed with acute ischemic stroke, NIHSS ≤ 5 and single item score ≤ 1 for vision, language, single limb, and no impairment of consciousness.
3. Time from symptoms onset to randomization within 4.5 hours; the onset time refers to the "Last Known Normal" (LKN).
4. Absence of large vessel occlusion on CTA.
5. Pre-stroke mRS ≤ 1.
6. Signed informed consent.

Exclusion Criteria:

1. Clinically confirmed valvular or non-valvular atrial fibrillation requiring anticoagulation therapy.
2. Intracranial hemorrhage or subarachnoid hemorrhage suggested by CT scan.
3. Acute coronary syndrome suggested by Electrocardiogram.
4. History of gastrointestinal bleeding.
5. Planned sequential IVT or endovascular treatment.
6. History of allergy to aspirin, clopidogrel, and/or alteplase.
7. Systolic blood pressure exceeding 185 mmHg and/or diastolic blood pressure exceeding 110 mmHg despite antihypertensive treatment.
8. Blood glucose ≤ 2.7 mmol/L.
9. Epileptic seizures during a stroke attack.
10. Recent trauma (\<15 days).
11. Recent intracranial or spinal cord surgery, head trauma, or stroke (\<3 months).
12. History of intracranial hemorrhage, aneurysm, vascular malformation, or brain tumor.
13. Active visceral hemorrhage (\<22 days).
14. History of anticoagulant use within 24 hours prior to onset.
15. Platelets \<100,000, PTT \> 40 seconds on heparin, or PT \> 15 or INR \> 1.7, or known bleeding disposition.
16. Anticipated life expectancy \< 3 months.
17. Pregnant or lactating women.
18. Participation in other clinical trials.
19. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
OStéopontin as a Marker Of StenoSIS - OSMOSIS

Our hypothesis is that a plasma protein named osteopontin (OPN) could serve as a biological predictive marker of acute AVF dysfunction. In several scientific studies, plasma OPN was correlated with coronary stent restenosis, and with cardiovascular outcome in patients with diabetes and renal insufficiency. This protein is secreted by several cellular types, like distal tubule epithelial cells, macrophages, but also fibroblasts and cardiac and vascular endothelial cells, in response to several specific stimuli. It acts like a cytokine, inducing immunological mechanisms as well as tissue remodeling.

The main objective of this study is to show that the amount of plasma OPN is higher in patients presenting with an AVF stenosis, compared with patients with a functioning AVF.

OSMOSIS is a monocentric pilot study that will include patients into two groups during 12 months (no specific follow-up). The control group will include patients that have been dialyzed on an AVF, in the dialysis center of Nice University Hospital, for at least 3 months without any incident. The experimental group will include hemodialysis patients hospitalized in the department of vascular surgery for acute AVF dysfunction, needing endovascular or open surgical revision for venous stenosis.

Blood will be withdrawn right before dialysis or surgical procedure. Plasma OPN will me measured by ELISA. Their clinical data would be collected from medical file at the same time. After the procedure, patients will be followed-up according to usual protocols.

To show a significant difference of 100ng/mL plasma OPN between the two groups, with a power of 90% and alpha risk of 0.05, we plan to include 76 patients


Eligibility Criteria:
Inclusion Criteria:

* Patients under a social security scheme
* Written informed consent obtain
* 18 years old or older
* end-stage renal failure disease with 3 months dialysis minimum on a native arteriovenous fistula

Non-inclusion Criteria:

* Subject under juridicial protection
* Pregnant or lactating women
* Subject already enrolled in a clinical trial involving a drug or an implantable medical device

Exclusion Criteria:

* Withdrawal of consent
* Investigator or sponsor decision
Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders

This study is a pilot, proof of concept study to determine the effects of administering an oral short-chain fatty acid (SCFA) supplement to Rheumatoid Arthritis (RA) patients with inadequate response to methotrexate (MTX). The study will include up to 35 participants to obtain a sample size of at least 25 participants taking the oral supplement. The researchers hypothesize that oral SCFA will change the participants' gut microbiome and regulatory immune responses. Clinical data to assess for adverse events, stool, urine samples and peripheral blood will be collected at baseline, 1 month, and with an optional 2 month time-point. Fecal microbiome will be analyzed. Adaptive immune responses will be analyzed from participant blood samples.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of RA meeting 2010 ACR/EULAR for RA and/or treating MD diagnosis
2. Inadequate response to MTX per treating MD at maximum tolerated dose.
3. Able and willing to provide written informed consent prior to any study specific procedures
4. Age 18 years and above at time of enrollment
5. Subjects not excluded based on race or ethnicity

Exclusion Criteria:

1. Participants who are pregnant or are currently breastfeeding
2. History of sensitivity to study compound or any of their excipients
3. Previous intolerance to SCFA or related compounds
4. Current antibiotic treatment (within 3 months of screening) at discretion of PI
5. Current consumption of probiotics (within 3 months of screening) at discretion of PI
6. Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)
7. Renal failure (eGFR \<30 or requiring dialysis) by history
8. History of other autoimmune disease at discretion of PI
9. Current immunodeficiency state (e.g., cancer, HIV, others)
Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With CJA Treated by Corticosteroid Therapy

* To evaluate the effect of increasing the growth hormone dose on the statural response
* To assess the value of early treatment during the course of arthritic disease by comparing the height acquired in the medium term by children in the two groups: treated from the start, or 1 year to 15 months after the diagnosis of CJA, or treated for 4 years after the diagnosis

This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* This study will be proposed to all patients previously included in study CTN 97-8129-016

Exclusion Criteria:

* Discontinuation of corticosteroid therapy for more than a year during study CTN 97-8129-016
* Patients withdrawing from the study prematurely
Impact of Drug Therapy and Co-Morbidities on the Development of Renal Impairment in HIV-Infected Patients

Tenofovir (TDF)-containing regimens may be associated with decreasing renal function in HIV-infected patients concurrently treated with boosted PI's and/or have co-morbid conditions including diabetes mellitus, hypertension, anemia, hepatitis B, and hepatitis C.

COL109413 is a Phase IV retrospective database study involving the review of medical records of approximately 850 HIV-infected patients treated at a single center (Peabody Health Clinic, Dallas, Texas) and followed for up to a 4-year period (2003-2006). Patients whose GFR decreased \>25% from baseline (BL) will be identified and their disease and treatment characteristics will be compared to those of patients whose GFR did not change. GFR will be calculated by both the MDRD and the Cockcroft-Gault methods.

The following information will be noted: patient age, weight, gender, race/ethnicity, viral load, CD4 cell count, serum creatinine and other available laboratory data, start of HAART therapy (TDF - vs non-TDF-containing), changes in drug treatment, co-morbidities (hypertension, diabetes mellitus, anemia, hepatitis C virus or hepatitis B virus infection), drug treatment for co-morbidities and non-HIV-related illnesses, and adherence by prescription refill. The study endpoints will be: time from treatment initiation-to-event (GFR decrease \>25% from BL) analysis between TDF-containing vs non-TDF-containing antiretroviral therapy; number of patients who convert from National Kidney Foundation-defined mild to moderate renal impairment or from moderate to severe renal impairment in the TDF vs non-TDF-treated patients; effect of co-morbidities and concomitant medications on time to GFR decrease \>25% from BL.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive patients seen between 2003 and 2006

Exclusion Criteria:

* Fewer than two laboratory results
HIV-Related Stigma Intervention for Malaysian Clinicians

Key populations at risk of HIV (including men who have sex with men, people who inject drugs, transgender women, and female sex workers) are more likely to be infected with HIV but less likely than members of the general population to know of their HIV status, receive HIV prevention counseling, or be linked to HIV care services. Clinician stigma towards these groups remains a potent and persistent driver of these HIV disparities in many places of the world. The investigators propose to incorporate evidence-based stigma reduction tools into a popular teletraining platform for clinicians and pilot test the resulting intervention (Project ECHO® for HIV Prevention and Stigma Reduction) with clinicians in Malaysia, a context wherein clinician stigma and HIV disparities are substantial.


Eligibility Criteria:
Inclusion Criteria:

* practicing general practitioner or family medicine specialist in Malaysia

Exclusion Criteria:

-
Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint

The purpose of this study is to allow patients to undergo surgery with the SR™ PIP (Proximal Interphalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device

The purpose of this IRB approved study is to allow patients to undergo surgery with the SR™ PIP (Proximal Interphalangeal) Implants. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device. Use of the SR™ PIP is approved for humanitarian use by the FDA when either the patient is in need of a revision of failed PIP prothesis(es) or the patient expects to place his/her hand under loading situation which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic PIP joint.

Eligibility Criteria:
Inclusion Criteria:

* patient is in need of a revision of failed PIP prosthesis(es)
* patient expects to place his/her hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic PIP joint

Exclusion Criteria:

* patient is not in need of a revision of a failed PIP prothesis(es)
* patient is eligible to use an alternative implant