cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus

We hypothesize that atorvastatin will decrease HCV viral load in patients taking the medication.

Cholesterol is needed for HCV virion production. Cell culture studies have shown that atorvastatin (an HMG-CoA reductase inhibitor) decreases HCV viral replication. As atorvastatin has been proven to decrease heart attack and stroke in patients with high cholesterol, this medication is indicated for the treatment of elevated cholesterol in at risk individuals. Therefore we propose to study the effect atorvastatin has on the viral load of patients initiated on atorvastatin therapy for their elevated cholesterol.

Men and women ages 30 to 80 infected with HCV viremia whose physician has determined need cholesterol lowering medication will be recruited by the study investigators from Massachusetts General Hospital.

The study investigators will approach the potential subject after the referring doctor has ascertained that the potential subject is interested in meeting with the investigator.

Each subject who consents will undergo phlebotomy of 10 cc of blood three times. Once prior to the initiation of atorvastatin to measure the patients viral load. In addition, patients will undergo phlebotomy 4 and 12 weeks after the initiation of atorvastatin. The week 12 phlebotomy is required in all patients started on atorvastatin to monitor for side effects. Therefore patients who enroll in this study will undergo one additional phlebotomy. As part of our study an extra 10 cc of blood will be taken at these times to measure the patients HCV viral load.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic HCV.
* Patients who need treatment for their elevated cholesterol:

  * Total cholesterol \>240 or
  * LDL \>160 without cardiac risk factors or
  * LDL \>130 with two cardiac risk factors (hypertension, smoker, family history of heart attach, or HDL \<40 for men or \<50 for women) or
  * LDL \>100 with diabetes or known coronary artery disease

Exclusion Criteria:

* Impaired mental ability preventing a subject from understanding the protocol or from completing the entire study.
* HCC
* A history of an adverse reaction to any HMG CoA reductase inhibitor.
* Patients who are on HCV treatment, who plan to initiate HCV treatment within 3 months, or who discontinued HCV treatment within the last 3 months.
* Patients whose aminotransferases are \> 5 times the upper limit of normal.
Changes in Dynamic q Angle in Patients With Chronic Ankle Instability

This study investigates the difference in dynamic Q-angle of patients with chronic ankle instability and those without.


Eligibility Criteria:
Inclusion criteria:

* Subjects aged between 18 and 30 years.
* Subjects with a history of LAS for at least one year before the study onset, that required at least 1-day weight-bearing restriction.
* Subjects with a self-reported tendency of ≥2 giving way episodes during 6 months before enrollment in the study.
* Subjects with a perception that the injured ankle was chronically weaker, more painful, and/or less functional than the contralateral ankle before the first LAS.
* Subjects who scored less than 24 in the Cumberland Ankle Instability Tool (CAIT), a validated ankle instability specific questionnaire of 9 items, to determine if functional ankle instability is present.

Exclusion criteria

* Subjects who had bilateral LAS
* Subjects with a history of lower extremity injury, fracture, or surgery
* Subjects who participated in supervised or unsupervised ankle rehabilitation within a year before enrollment in the study
* Subjects with LAS within 3 months before participation
* Subjects with a history of knee pain during the last 6 months.
* Subjects diagnosed with knee osteoarthritis.
Feasibility Study of Balloon Eustachian Tuboplasty (BET)

This is a study that aims to evaluate the feasibility of undertaking a United Kingdom (UK) multi-centre randomised controlled trial of BET for the treatment of moderate (grade 2 or 3) retraction pockets (RPs). This future study will aim to address the question: Does BET improve symptoms scores, audiometry and otoscopic appearance of Grade 2-3 pars tensa RPs in adult patients?

Currently conservative treatments for this condition has been shown to be ineffective; there is a significant risk of progression to hearing loss or more serious complications in untreated retraction pockets; and the surgical treatments available to us in the UK not only have a number of risks and drawbacks, but also do not aim to treat the underlying cause (Eustachian Tube dysfunction (ETD)).


Eligibility Criteria:
Inclusion Criteria:

Adult patients over 18 years old with grade 2-3 retraction pocket of the tympanic membrane as assessed by study clinician.

Exclusion Criteria:

* Craniofacial abnormalities (assessed by history and examination)
* Cholesteatoma (assessed by history, otoscopy, tympanogram, PTA)
* Nasopharyngeal tumours (assessed by flexible nasendoscopy)
* Adenoid hypertrophy (assessed by flexible nasendoscopy)
* Patulous ET (assessed by history, otoscopy and tympanogram)
* Previous middle ear surgery (assessed by history and otoscopy)
* Concurrent use of anticoagulant medication
A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin

The study aims to compare blood pressure and pulse in male healthy subjects taking mirabegron and tamsulosin both alone and in combination.

Treatment arm 1 (effect of mirabegron on tamsulosin): Subjects are randomized into one of two sequences.

Subjects receive 2 singles doses of tamsulosin, once in the absence of mirabegron and once in the presence of mirabegron.

24-hour Cardiovascular (CV) profiles are taken at both baseline days and after the single dose of tamsulosin /combination dose in each sequence. Regular blood samples are also taken to check for a potential Pharmacokinetic (PK) interaction.

Treatment arm 2 (effect of tamsulosin on mirabegron): Subjects are randomized into one of two sequences.

Subjects receive 2 singles doses of mirabegron, once in the absence of tamsulosin and once in the presence of tamsulosin.

24-hour CV profiles are taken at both baseline days and after the single dose of mirabegron/combination dose in each sequence. Regular blood samples are also taken to check for a potential PK interaction.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2

Exclusion Criteria:

* Known or suspected hypersensitivity to mirabegron and/or tamsulosin HCl, or any components of the formulations used
* Any of the liver function tests (i.e. Alanine Aminotransferase (ALT) and Asparate Aminotransferase (AST) above the upper limit of normal at repeated measures (at least one more time)
* Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever)
* Any prior clinically significant psychiatric history including hospitalization for mental health management
* Subject is at risk of urinary retention based on medical history
* Any clinically significant abnormality following the investigator's review of the pre-study physical examination, Electrocardiogram (ECG) and clinical laboratory tests
* Heart rate and/or blood pressure measurements at the screening and admission visits as follows: Heart rate \<50 or \>90 bpm; mean systolic blood pressure \<90 mm Hg or \>140 mmHg (\>160 mmHg for subjects 65 years or older); mean diastolic blood pressure \<60 mm Hg or \>90 mmHg (\>100 mmHg for subjects 65 years or older) (blood pressure measurements to be taken after subject has been resting in supine position for 5 min; heart rate will be measured automatically; both to be taken in triplicate)
* A QTc interval of \> 430 ms after repeated measurements (at least two more times), a history of syncope, orthostatic hypotension, vertigo, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
* A hemoglobin value \<12.5 g/dl (7.8 mmol/l) and/or a hematocrit value \<37.9% and/or a Red Blood Cell count \<4.08 T/l (4080 mm3)
Triage of Abdominal Pain in the Emergency Department

The investigators aim to evaluate in a retrospective study the performance of the Swiss Emergency Triage Scale to identify at the door of the Emergency Department patients requiring emergent intervention.

All patients are triaged at the door of our Emergency Department using the Swiss Emergency Triage Scale. Patients with abdominal pain may be triaged in two different emergency levels (level 2: medical evaluation within 20 minutes, level 3: medical evaluation within 2 hours). These levels are determined using a set of specific criteria.

The aim of this study is to evaluate the validity of these specific criteria in order to identify promptly patients with abdominal pain the will require an emergent intervention during their stay in the Emergency Department.

Eligibility Criteria:
Inclusion Criteria:

* \>= 16 y
* abdominal pain as the main complaint

Exclusion Criteria:

* none
eHealth Evidence-based Intervention (EBI) for Latino Youth in Primary Care

The purpose of this study is to test the relative effectiveness of a Hispanic-specific eHealth intervention, "e-Health Familias Unidas," in preventing and reducing drug use, sexual risk behaviors, and STIs among Hispanic youth in primary care. Families will be recruited through four pediatric primary care settings. Pediatric staff and research team members, including nurse assistants and mental health professionals, will implement eHealth Familias Unidas.


Eligibility Criteria:
Inclusion Criteria:

* Female and male adolescents of Hispanic immigrant origin, defined by at least one parent born in a Spanish speaking country of the Americas. Parent must understand Spanish given that parent sessions are delivered in Spanish.
* Adolescent between the ages of 12 - 17 years
* Adolescent living with an adult primary caregiver who is willing to participate
* Families must have broadband internet access on a device, including (but not limited to) a smart phone, iPad, tablet, a home computer or a computer at another location (e.g., school, library, etc.)

Exclusion Criteria:

* Families reporting plans to move out of the South Florida area during the study period
* Families reporting that adolescent has been diagnosed with a developmental delay
Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.


Eligibility Criteria:
Inclusion Criteria:

* Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status
* TWSTRS severity, disability and total scores meeting the defined criteria at baseline

Exclusion Criteria:

* Pure anterocollis or pure retrocollis
* In apparent remission from cervical dystonia
* Previous poor response to the last two botulinum toxin type A or type B treatments
* Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin
A Comparison Between Conventional Surgery and Piezosurgery

Evaluation of the effect of conventional and piezo-surgery on the secretion of Heat Shock Protein (HSP70) and on the vial bone cells at the peripheral bone cut sides after the removal of impacted mandibular third molars on both sides of the jaw.

The study is about measuring the amount of HSP70 using Elisa kit for detecting HSP70 and mason trichrome for histological findings in which the study samples are patients who have bilateral impacted mandibular third molar to be extracted with bone removal. First we collect bone sample for mason trichrome with either method then we collect the second samples after removing most of the bones cover the impacted third molar for checking HSP70 levels. Then the bone samples are treated using a special protocol to eliminate the protein from bone samples for the Elisa analysis. The other bone samples are going to be studied under the microscope.

Eligibility Criteria:
Inclusion Criteria:

* bilateral identical impacted third molar that need at least 3 mm of bone removal

Exclusion Criteria:

* Pregnancy
* Smokers
* Infectious diseases
* Infections around third molars (i.e. pericoronitis).
* Alcoholic patients
Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement

The purpose of this study is to evaluate the efficacy, safety, and adequacy of Endoscopic Ultrasound (EUS) Portal Pressure Gradient Measurement (PPGM) in patients undergoing EUS-guided liver biopsies.

Patients undergoing EUS-guided liver biopsy may qualify to participate in this study. The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS- Portal Pressure Gradient Measurement (PPGM) in patients with liver disease referred for EUS-guided liver biopsy.

Eligibility Criteria:
INCLUSION CRITERIA

* Age 18 years or older
* Patient who has been referred for EUS procedure and direct PPG measurement and -undergoing EUS-guided liver biopsy
* History of liver disease or suspected cirrhosis and considered for PPGM

EXCLUSION CRITERIA

* Patient is less than 18 or greater than 85 years of age
* Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
* Patient is unwilling or unable to sign and date the informed consent
* Patient for whom endoscopic procedures are contraindicated.
Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts

This study evaluates individuals without pancreatic cancer, but who have been determined to be at higher-than-average lifetime risk of developing pancreatic cancer to help detect pancreatic cancer or other cancers at an earlier time when they might be more easily treated and cured.

PRIMARY OBJECTIVES:

I. To develop a cohort (biobank of biospecimens and data) of subjects without pancreatic cancer who are at highrisk for pancreatic cancer due to: a strong family history, a mutation in a known pancreatic cancer predisposition gene, or fukuoka worrisome or high-risk pancreatic cysts.

II. To follow the cohort subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes.

III. To make biospecimen available to PCDC-approved projects to validate potential biomarkers for performance using nested case-control prospective designs.

OUTLINE: This is an observational study.

Participants undergo blood sample collection, complete questionnaires, have their medical records reviewed and undergo pancreatic cyst fluid collection during standard of care endoscopic ultrasounds fine needle aspiration.

Eligibility Criteria:
Inclusion Criteria:

* PDAC FAMILY HISTORY OR PDAC RELATED GENETIC MUTATIONS:

  * Age: 50 or older, plus at least one of the following:

    * Mutation unknown or absent:

      * 2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject;
      * OR 2+ affected first degree relatives (FDR), defined as blood related parents, siblings, or children)
    * Known pathogenic/likely pathogenic (P/LP) mutation in at least one of the following:

      * CDKN2A/p16, PJS (STK11), Hereditary pancreatitis with confirmed protease serine 1 (PRSS1)
    * OR 1+FDR or second degree relative (SDR) with PDAC and a known P/LP mutation in one or more of:

      * ATM, BRCA1, BRCA2, PALB2, Lynch syndrome (MLH1, MSH2, MSH6, PMS2, EPCAM), TP53

HIGH-RISK OR WORRISOME PANCREATIC CYSTS:

* 18 years of age or greater and meeting Fukuoka worrisome (FW) or Fukuoka high-risk (FHR) criteria

  * High risk stigmata:

    * Obstructive Jaundice in a patient with cystic lesion of the head of the pancreas
    * Enhancing mural nodule ≥ 5 mm
    * Main pancreatic duct ≥ 10 mm
  * Worrisome features:

    * Presence of pancreatic duct stricture, defined as focal pancreatic duct narrowing with upstream duct =\> 6 mm
    * Cyst ≥ 3 cm
    * Enhancing mural nodule \< 5 mm
    * Thickened/Enhancing cyst wall
    * Main duct size 5-9 mm
    * Pancreatitis
    * Lymphadenopathy
    * Increased CA 19-9
    * Cyst growth rate ≥ 5 mm /2 years

Exclusion Criteria:

* \* Is unable to provide informed consent

  * Has received a non-autologous bone marrow transplant or has an active hematologic malignancy (i.e., leukemia or lymphoma)
  * Current or prior history of PDAC or total pancreatectomy
  * Is currently a prison inmate
  * Is not able to speak or read English
The Lipid-Rich Plaque Study

The purpose of this study is to enhance medical knowledge of the causes of future coronary problems. Many studies in patients who have already experienced a coronary problem point to the danger associated with plaques that are rich in cholesterol. This study determines if the near-infrared method of detection of these fatty plaques can predict future events. If dangerous plaques can be identified, there are many treatments already available that could be tested for their ability to prevent coronary events.


Eligibility Criteria:
General Inclusion Criteria:

* Subjects presenting for coronary angiography in whom IVUS imaging is likely to be performed for clinical purposes.
* Greater than 18 years of age.
* Clinical presenting symptoms meeting one of the three criteria below:

  1. Subjects presenting with an acute coronary syndrome (ACS) including at least one of the following:

     1. Elevated cardiac biomarkers with CK-MB or troponin greater than upper limits of normal;
     2. ST depression or ST elevation \>1mm in 2 or more contiguous leads in the absence of LVH, paced rhythm, BBB or early repolarization;
     3. A stabilized patient 24 to 72 hours post STEMI;
  2. Unstable angina pectoris;
  3. Stable angina pectoris and/or a positive functional study with evidence of ischemia.

Angiographic Inclusion Criteria

* At least one Suspected Index Culprit Lesion requiring imaging with IVUS and/or NIRS for clinical indications.
* At least two native epicardial coronary arteries (which may include the Suspected Index Culprit Artery) eligible for imaging with NIRS-IVUS.

IVUS/NIRS Imaging Inclusion Criterion

* A minimum of a total 50 mm of coronary artery not involved in a prior or Index Procedure PCI (including the 5mm borders on either edge of the site receiving PCI) must be scanned. This 50mm total length may include contributions from the Suspected Index Culprit Arteries and from Index Non-Culprit Arteries. This total length must include contributions from two or more native imaged arteries.

Exclusion Criteria:

* Unstable patients (STEMI within the prior 24 hours; cardiogenic shock, hypotension needing inotropes, hypoxia needing intubation, and IABP) and patients that had a procedural complication (coronary dissection, perforation or a complication that would necessitate immediate-unplanned revascularization) during index PCI procedure.
* History of CABG or planned CABG within 6 months following NIRS-IVUS imaging.
* Patient has additional lesion(s) that needs a staged PCI.
* Subject life expectancy is less than 2 years at time of index catheterization.
* Subject with ejection fraction (EF) \<30%.
* Subject pacemaker dependent/paced rhythm.
* Subject pregnant and lactating.
* Any other factor that the investigator feels would put the patient at increased risk or otherwise make the patient unsuitable for participation in the protocol
* Patients undergoing performance of PCI in all three major vessels during the index PCI.
Gluten-free Diet in PSC and IBD

Primary sclerosing cholangitis (PSC) is a progressive disease of the biliary tree, which represents one of the most frequent indications for orthotopic liver transplantation (OLTx) in developed countries. There are several lines of evidence that dietary gluten/gliadin displays chronic pro-inflammatory, LPS-like properties. Recent evidence demonstrated the protective effect of gluten- free diet (GFD) in autoimmune diseases like type 1 diabetes, irritable bowel syndrome, non-celiac gluten sensitivity and some neurological disorders. This study is intended to explore therapeutic effect of GFD on PSC and IBD in prospective self-controlled mono-centric intervention study.

Hypothesis: Avoidance of gluten in diet will reduce progression, symptoms and intestinal inflammation in PSC and UC patients.


Eligibility Criteria:
Inclusion Criteria (for PSC group):

* Established diagnosis of PSC (based on radiologic features, typical finding on MRCP or ERCP)
* Age 18 - 65 years
* ALP 1,5x higher than ULN
* Signed informed consent

Exclusion Criteria (for PSC group):

* Patients on gluten-free diet
* Patients with coeliac disease or wheat allergy
* Liver transplant recipients
* PSC/AIH overlap syndrome
* Other causes of liver disease
* Radiologic or clinical signs of decompensated liver cirrhosis
* Advanced liver cirrhosis (MELD score ˃ 15)
* Recurrent acute cholangitis or cholangiogenic sepsis in past 3 months
* Use of antibiotics in past 3 months
* History of malignancy
* Pregnant women
* Not signed informed consent

Inclusion criteria (for UC group):

* Ulcerative colitis diagnosed based on clinical, endoscopic and histological findings
* Extension of affected colon \> 15cm
* Mayo score 0-4
* Signed informed consent

Exclusion criteria (for UC group):

* CMV, Clostridium difficile enterocolitis in past 3 months
* Use of antibiotics in past 3 months
* Patients with coeliac disease or wheat allergy
* Patients on gluten-free diet
* Pregnant women
* Not signed informed consent
* Biologic therapy
* Methotrexate
* Prednison \> 10 mg
* Not signed informed consent
Dose and Duration of Metronidazole and Amoxicillin for Treatment of Chronic Periodontitis

The aim of this study was to compare the clinical and microbiological outcomes of different dosages of metronidazole (MTZ) and of the duration of the systemic administration of MTZ and amoxicillin as adjunct to scaling and root planing (SRP) in the treatment of generalized chronic periodontitis (GChP).

Randomized clinical trials and systematic reviews have shown that the use of the combination of metronidazole (MTZ) and amoxicillin (AMX) significantly improves the benefits of the SRP in the treatment of subjects with periodontitis. However, the optimal dosage and interval of administration of these antibiotics are still unclear. Therefore, the aim of this study was to compare the clinical and microbiological outcomes of different dosages and duration of the systemic administration of the combination of MTZ and AMX as adjunct to scaling and root planing (SRP) in the treatment of generalized chronic periodontitis (GChP). One hundred ten subjects will be randomly assigned to receive SRP plus placebo, or SRP combined with 250 mg or 400 mg of MTZ, plus AMX (500 mg) TID, for either 7 or 14 days. Subjects will be clinically and microbiologically monitored up to 1 year post-therapy.

Eligibility Criteria:
Inclusion Criteria:

* ≥30 years of age;
* at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction)
* a minimum of 6 teeth with at least one site each with probing depth (PD) and clinical \* attachment level (CAL) ≥5 mm;
* at least 30% of the sites with PD and CAL ≥4 mm and bleeding on probing (BOP).

Exclusion Criteria:

* pregnancy
* breastfeeding
* current smoking and former smoking within the past 5 years;
* systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis);
* scaling and root planing an in the previous 12 months;
* antibiotic therapy in the previous 6 months;
* long-term intake of anti-inflammatory medications;
* need for antibiotic pre-medication for routine dental therapy;
* allergy to metronidazole and/or amoxicillin.