cyrilzakka/clinical-trials huggingface dataset:
Menopause is a Critical Factor in Determining Failure of Antiviral Therapy in Women With Chronic Hepatitis C

Menopause represents a critical period in a woman's life as the hormonal changes and the failing ovarian function not only determine relevant modifications in the reproductive function but also in many other conditions and organs that apparently are scarcely linked with hormones. The PI's centre has among its main goals the treatment of chronic liver disease; in the last years, a increasing interest in gender-related issues has grown.

Goal of this study is to verify the impact of menopause on response to antiviral therapy for CHC and in determining more severe fibrosis in comparison with age-matched men. To achieve this goal a database of all the PEG IFN/Ribavirin patients treated in the GI Unit of the University of Modena and Reggio Emilia in the last 7 years will be set up. Demographic, clinical and biochemical data as well data regarding the reproductive history, time, type, length of estrogen deprivation and of hormone-replacement therapy will be collected.

The study is designed retrospective epidemiological cohort study. Overall, a group of 442 women (168 still in fertile age; 274 menopausal) with HCV-positive CAH who underwent PEG IFN treatment in the last 5 years will be evaluated. For comparison, a group of 548 HCV-positive males with CAH will be evaluated. Liver biopsies before undergoing standard antiviral therapy will be scored for fibrosis, inflammation and steatosis. In women the presence, type and timing of menopause, associated hormonal/metabolic features and serum interleukin-6 (IL-6) and hepatic tumor necrosis factor-α (TNF-α) levels will be evaluated.

The primary endpoint will be evaluation of SVR in females (in fertile and menopausal age) and in males.

Eligibility Criteria:
Inclusion Criteria:

* All women treated for HCV chronic hepatitis, at the Unit Gastroenterology, University of Modena and Reggio Emilia, in the last 7 years.
* Control group is a cohort matched for age (ratio 1:1) selected from a group of 558 men with chronic HCV treated in the same period

Exclusion Criteria:

* No exclusion criteria aret pre-defined as the study includes all patients who were treated for chronic HCV hepatitis; exclusion was made upstream of the constitution of this cohort.
Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)

The purpose of AROAPOC3-3001 is to evaluate the efficacy and safety of ARO-APOC3 plozasiran) in adult participants with familial chylomicronemia syndrome (FCS). Participants who have met all eligibility criteria will be randomized to receive 4 doses of plozasiran or matching placebo administered subcutaneously. Participants who complete the randomized period will continue in a 2-year open-label extension period where all participants will receive plozasiran.


Eligibility Criteria:
Inclusion Criteria:

* Fasting TG ≥ 10 mmol/L (≥ 880 mg/dL) at screening refractory to standard lipid lowering therapy
* Diagnosis of FCS
* Willing to follow dietary counseling as per investigator judgement based on local standard of care
* Participants of childbearing potential (males \& females) must use highly-effective contraception during the study and for at least 24 weeks following the last dose of study medication. Males must not donate sperm during the study and for at least 24 weeks following the last dose of study medication
* Women of childbearing potential must have a negative pregnancy test at Screening and cannot be breastfeeding
* Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1

Exclusion Criteria:

* Current use or use within the last 365 Days from Day 1 of any hepatocyte-targeted siRNA or antisense oligonucleotide molecule
* Diabetes mellitus newly diagnosed within 12 weeks of Screening or where HbA1c ≥ 9.0% at Screening
* Active pancreatitis within 12 weeks before Day 1
* History of acute coronary syndrome event within 24 weeks of Day 1
* History of major surgery within 12 weeks of Day 1
* Uncontrolled hypertension
* On treatment with human immunodeficiency virus (HIV) antiretroviral therapy
* Seropositive for hepatitis B virus (HBV) or hepatitis C virus (HCV)
* New York Heart Association (NYHA) Clas II, III, or IV heart failure

Note: Additional Inclusion/Exclusion criteria may apply per protocol
Clinical Usefulness and Efficacy of Intrathoracic Impedance Monitoring Using the OptiVol Patient Alert(TM)

In this study we investigate the clinical value and efficacy of OptiVol (TM) impedance measurements by Medtronic (R) ICD's. We aim to determine sensitivity and positive predictive value for detecting heart failure. We also investigate if left ventricular filling pattern measured by echocardiography and/or brain natriuretic peptide (BNP) level can be used to improve the positive predictive value of the Optivol alert

Patients who have a Medtronic (R) ICD equipped with the Optivol (TM) impedance monitoring will be included in your study after informed consent. The OptiVol (TM) feature will be activated and at baseline data is collected (blood sample including BNP, electrocardiography, echocardiography, chest X-ray and ICD check-up). During follow-up patients will be re-assessed in case of an OptiVol alert or in case of heart failure.

Eligibility Criteria:
Inclusion Criteria:

* chronic heart failure of any cause
* implanted Medtronic ICD with OptiVol impedance monitoring

Exclusion Criteria:

* inability to receive informed consent
Total Knee Arthroplasty Videofluoroscopy

The primary objective is to quantify and compare the three-dimensional kinematics of the cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved CR Fixed Bearing TKA (both DePuy Synthes, Johnson and Johnson) during daily activities.

The secondary objective is to describe the kinematics in terms of range of motion, patterns of anterior-posterior motion of the nearest medial and lateral points ("posterior femoral rollback") and tibio-femoral internal/external rotation as well as the kinetics during daily activities, such as level gait, a deep knee bend (only ATTUNETM subjects), sitting down onto a chair, standing up from a chair and stair descent by means of video-fluoroscopy.

Furthermore, the encoded data will be handed over to DePuy Synthes (Johnson and Johnson) and to the Center for Orthopaedic Engineering of the University of Denver, where it will be used within a musculoskeletal model with the aim of simulating tibiofemoral contact mechanics and changes in the musculoskeletal system due to the TKA.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral TKA (ATTUNETM/Sigma) due to osteoarthritis
* BMI ≤ 33
* Good clinical outcome, KOOS \> 70
* No or very low pain VAS \< 2
* At least one year post-op
* Standardized general health survey score (SF-12) within the normal range for people in their age group

Exclusion Criteria:

* Actual significant problem on lower extremities
* Misaligned TKA
* Any other arthroplasty at the lower extremities
* Patient incapable to understand and sign informed consent
* Incapable of performing the motion tasks
* Pregnancy
The Use of Antibiotic Sinonasal Rinse After Sinus Surgery

Double blind placebo controlled trial to evaluate whether the routine use of nasal irrigation with mupirocin is more effective than saline irrigations alone in reducing symptoms of chronic rhinosinusitis in the early postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Rhinosinusitis
* Undergoing endoscopic sinus surgery

Exclusion Criteria:

* Age under 18
* Documented adverse reaction to mupirocin
Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease

Cardiovascular disease is the most common cause of death in the world. Most of the attention in treating ischemic heart disease (IHD) is understandably directed toward treating coronary artery disease. However there are other treatable culprits in these patients.

Left ventricular hypertrophy (LVH) is widespread in IHD patients, even in the absence of hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. In one study, the presence of LVH was a stronger predictor of mortality than either multivessel cor-onary disease or impaired LV function.

Metformin is an antihyperglycemic agent with a history of successful use in type 2 diabetes. In the UKPDS (United Kingdom Prospective Diabetes Study), metformin was associated with a 39% lower risk of myocardial infarction compared with conventional therapy. Metformin also offered dual benefits of improving vascular function and lessening ischemia in nondiabetic patients.

Hence, the main aim of this study was to assess whether metformin could regress LVM in patients with IHD. The secondary aim was to assess the effect of metformin on LV volumes and endothelial function in this patient group.


Eligibility Criteria:
Inclusion Criteria:

* They had to have normal glucose tolerance.
* They had to have either angiographically documented coronary artery disease or a previous history of myocardial infarction.
* They were required to have an office BP \< 130/80 mm Hg
* The presence of LVH on echocardiography (American Society of Echocardiography criteria LVM index \[LVMI\] \> 115 g/m2 for men and \> 95 g/m2 for women).

Exclusion Criteria:

* They were currently prescribed metformin.
* They had renal and liver dysfunction, heart failure, or malignancy, or were unable to give informed consent.
* Patients with contraindications to cardiac magnetic resonance (CMR) (pacemakers, claustrophobia) were also excluded, as were pregnant or lactating women.
Right Ventricular Function at Rest in Highlanders/Lowlanders

The purpose of the current study is to evaluate the progression of right ventricular function and dimension in Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a cross sectional case-control study.


Eligibility Criteria:
Inclusion Criteria:

* high altitude pulmonary hypertension confirmed by clinical presentation and mean pulmonary artery pressure \>30 mmHg measured by echocardiography at altitude of residence.
* healthy subjects (high altitude controls)
* Both genders
* Age \>16 y
* Kyrgyz ethnicity
* born, raised and currently living at \>2500 m
* healthy subjects currently living at \<1000 m (low altitude controls)

Exclusion Criteria:

* Pulmonary hypertension from other causes, in particular from left ventricular failure as judged clinically and by echocardiography
* Excessive erythrocytosis
* Other coexistent disorders that may interfere with the cardio-respiratory system and sleep
* Regular use of medication that affects control of breathing
* Heavy smoking
Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma

MGCD0103 is an experimental drug that belongs to a class of drugs known as the histone deacetylase inhibitors, which may restore normal control in cancer cells by affecting the genes and proteins that are being made. Laboratory tests show that this new investigational anti-cancer drug can slow down the growth of human cancer cells in mice; two clinical research studies are currently being performed in humans with cancer and a similar study is being performed in patients with the same disease.

The purpose of this study is to find out what effect the experimental drug MGCD0103 has on patients with relapsed and refractory Hodgkin's lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic confirmation of relapsed or refractory classical Hodgkin's lymphoma.
* The patient has at least one site of measurable disease (≥ 2.0 cm) as measured by conventional techniques such as CT or MRI.
* Prior treatment: there is no limit to number of prior therapies. Patients who had prior allogeneic stem cell transplants and do not have evidence of graft versus host disease and are not receiving immunosuppressive agents are eligible if they meet all other inclusion criteria.
* ECOG performance status of 0 or 1.
* Aged 18 years or older (no safety data yet for ages \< 18).
* Laboratory requirements (must be done within 7 days prior to study initiation).

Exclusion Criteria:

* Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia \[CIN/cervical in situ\] or melanoma in situ). Prior history of cancer is allowed, as long as there is no active disease.
* Pregnant or lactating women. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test documented within 7 days prior to start of study drug.
* WOCBP and men whose partners are WOCBP must use an acceptable method of contraception while enrolled in this study, and for a period of 3 months following study drug treatment.
* Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever \> 38.5°C (not due to tumor fever) on the day of scheduled dosing.
Multicenter Efficacy Study of Recombinant Human Erythropoietin in Acute Ischemic Stroke

The purpose of this randomized, double-blind, placebo-controlled multicenter study is to determine in a cohort of 506 patients with acute ischemic stroke in the middle cerebral artery territory, the effect of a three-day high-dose, intravenous erythropoietin treatment on functional outcome up to a follow-up of 90 days.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke in the middle cerebral artery territory
* Clearly defined time of onset
* Confirmed by MRI (DWI, Flair)
* NIH Stroke Scale ≥ 5
* Age \> 18 years
* Treatment within 6h after onset of symptoms
* Informed consent by patient, relatives or independent physician
* Life expectancy \> 90 days

Exclusion Criteria:

* Coma or precoma (level of consciousness ≥ 2 in NIH Stroke Scale)
* Previous stroke within the same territory
* Intracranial or subarachnoidal hemorrhage
* Traumatic brain injury or brain operation within the last 4 weeks
* Neoplasia, septic embolism, infectious endocarditis
* MRI contraindications
* Renal failure (i.e. dependent on dialysis)
* Known malignant/life-threatening disease
* Known myeloproliferative disorder, polycythemia
* Known allergy or antibodies against erythropoietin
* Participation in other intervention trials
* Pregnancy
Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe Chronic Obstructive Pulmonary Disease (COPD) (DACOTA)

Chronic obstructive pulmonary disease (COPD) is a progressive and largely irreversible lung disease characterized by chronic bronchitis and/or emphysema, resulting in breathlessness, cough and sputum. As COPD progresses, patients experience increasing deterioration of their health-related quality of life, with greater impairment in their ability to work and declining participation in social and physical activities.

The aim of this non-interventional study is to evaluate data on quality of life in COPD patients in Germany in a real life medical setting under therapy with the phosphodiesterase-inhibitor (PDE-4) roflumilast (Daxas). Evaluation is based on two COPD specific questionnaires to assess the patient's health status over six months. During the study, lung function measurements such as spirometry will be conducted according to common medical standard. Daxas (tablet) will be administered once daily. The study will provide further data on the safety and tolerability of Daxas.


Eligibility Criteria:
Main Inclusion Criteria:

* severe COPD

Main Exclusion Criteria:

* Child pugh (classified B and C)
Mebendazole as Adjuvant Treatment for Colon Cancer

mebendazole treating colon cancer

mebendazole as adjuvant treatment for colon cancer

Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer stage 4.

Exclusion Criteria:

* Agranulocytosis
* Pregnancy
* Allergy to mebendazole.
A Study to Evaluate Whether Losartan Protects the Kidney in Hypertensive Diabetic Participants With Microalbuminuria (MK0954-365 AM1)

This study will evaluate whether losartan protects the kidney in hypertensive Type II diabetic participants with microalbuminuria.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus
* Hypertension and has received losartan 50 mg or losartan 100 mg for at least 6 months
* Microalbuminuria (defined as microalbuminuria \> 30 mg/g and \< 300 mg/g by spot urine test)
* Serum creatinine ≤1.5 mg/dL for men and ≤1.4mg/dL for women
* Urinalysis with white blood cells (WBC) \<5 cells per high power field
* Results of hemoglobin A1c (HbA1c), fasting blood glucose, serum creatinine, urine albumin/urine creatinine ratio and urinary analysis tests at baseline and 6 months after initiating the losartan therapy are available
* Medical history and co-morbidities (if available) listed in medical records
* Prescription information of antihypertensive regimen of losartan 50 mg or 100 mg available

Exclusion criteria:

* Treated with angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARB) before initiated treatment with losartan 50 mg or losartan 100 mg
* Enrollment in another clinical trial
Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS)

This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.


Eligibility Criteria:
Inclusion Criteria:

* Recent ESUS (between 7 days and 6 months), defined as:
* Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar, and
* Absence of cervical carotid atherosclerotic stenosis\> 50% or occlusion, and
* No atrial fibrillation after ≥ 24-hour cardiac rhythm monitoring, and
* No intra-cardiac thrombus on either transesophageal or transthoracic echocardiography, and
* No other specific cause of stroke (for example, arteritis, dissection, migraine/vasospasm, drug abuse)

Exclusion Criteria:

* Severely disabling stroke (modified Rankin score ≥4)
* Indication for chronic anticoagulation or antiplatelet therapy
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\^2
Microaspiration in Pulmonary Fibrosis

Hypothesis 1: Microaspiration, as diagnosed by bronchoalveolar lavage (BAL) pepsin, is common in patients with IPF.

Hypothesis 2a: Baseline clinical variables and co-morbid conditions are risk factors for microaspiration in patients with IPF.

Hypothesis 2b: Baseline biological variables reflecting alveolar epithelial injury and inflammation are markers of microaspiration in IPF.

Hypothesis 3a: Microaspiration will lead to a more rapid rate of decline in pulmonary function.

Hypothesis 3b: Microaspiration will lead to higher rates of urgent medical care use (i.e. unscheduled clinic visit, emergency room visit, or hospitalization).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IPF
* Ability ot provide informed consent

Exclusion Criteria:

* History of fundoplication or other gastroesophageal surgery
* Too ill to undergo bronchoscopy in the opinion of the investigator
Retrospective Observational Safety Effectiveness With Kuvan in hpA

A retrospective study to collect the effectiveness and safety data of the past treatment with KUVAN in Chinese patients with HPA caused by BH4 deficiency. The data was collected from relevant past medical history and past clinical and safety assessments.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent (unless exemption of obtaining consent is obtained as per local regulation). Assent (if required defined by local regulation and requirement) should also be obtained from the subject and the legal authorized representative.
* Diagnosed with BH4 deficiency per local practice.
* KUVAN® was taken at least 1 dose to treat HPA caused by BH4 deficiency during the period of observation.
* Baseline Phe concentration ≥ 450 µmol/L

Exclusion Criteria:

* Subject diagnosed to have Phenylketonuria (PKU)
* Has any condition that, in the view of the Investigator, the medical record of the subject in the duration of observation is not reliable, or not accessible.
Home-based Optimization of Mechanical Ventilation in Children

Some children who are born very early or have other congenital conditions may develop severe, long-term lung problems that make them need to use a breathing machine to live at home. There are no studies that identify the best ways to monitor a home breathing machine or adjust its settings. Increasingly, healthcare systems are using information collected at home to make more informed decisions about a patient's healthcare treatment, which is called "remote patient monitoring". This study will ask whether using remote patient monitoring can provide more complete information to a child's team of doctors, nurses, and respiratory therapists to help a child's healthcare team and family make more informed decisions about a child's home ventilator care. The investigators are hypothesizing it can safely decrease the level of breathing support children need while also avoiding emergency and hospital care and supporting their growth, development, and participation in daily life.

This is a single-arm, non-randomized, open-label trial using remote patient monitoring for chronic management of invasive home mechanical ventilation in children. The investigators hypothesize that integration of longitudinal physiologic data and patient reported outcome measures into routine clinical care over 4 months can optimize home mechanical ventilation use by 1) reducing the level home mechanical ventilation level of support, 2) improving patient and family quality of life, specifically participation in daily activities and patient's lung symptoms, and 3) improving family-reported shared decision-making and child's access to ventilator care. The investigators will also evaluate its usability within family life and provider workflows and assess early implementation outcomes.

Eligibility Criteria:
Family-Patient Inclusion criteria

* The patient uses invasive mechanical ventilation at home during any portion of the day at time of enrollment.
* The patient is 0 to 17 years old.
* The patient has at least one family caregiver (parent or other self-identified legal guardian) trained on home ventilator use who is willing to participate.
* The primary parental participant reads and speaks either English or Spanish.

Exclusion criteria

* The patient has progressive neuromuscular or other condition for which decreasing support during the day is not anticipated.
* The patient is already off of ventilation during the day while awake.
* The patient will turn 18 during participation.
* The patient has planned a transition of care to another institution or move during the planned study period after enrollment.
* The patient is in active hospice or similar end-of-life care at time of study enrollment.
* The patient is living in long-term institution, transitional facility, or not within a stable home setting during the study period.
Retrospective PNS Study

Retrospective PNS Study


Eligibility Criteria:
Inclusion Criteria:

A. Subjects are at least 18 years of age, B. Subjects have been diagnosed with refractory chronic pain, C. Subject has been implanted with a permanent Freedom Peripheral Nerve Stimulation System.

Exclusion Criteria:

A. Any additional active implanted devices for the treatment of chronic pain in addition to the Freedom Peripheral Nerve Stimulation System.