cyrilzakka/clinical-trials huggingface dataset:
RWS of Inetetamab HER2 Positive Advanced Breast Cancer

This non-Interventional study will describe and analyze the clinical use of Inetetamab in clinical practice in the treatment of HER2 positive advanced breast cancer in the real world.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with stage IV breast cancer
2. Patients with HER2 positive status
3. Patients that received Inetetamab
4. Patients that began Inetetamab therapy prior to June 30, 2021.

Exclusion Criteria:

Patients treated with an investigational anticancer agent Inetetamab
Evaluation of Comfort With Xibrom (Bromfenac Ophthalmic Solution)0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT)

The objective of this study is to evaluate and compare the comfort of bromfenac or nepafenac following SLT.

Open label, single armed, cross over controlled study to evaluate comfort and IOP (Intraocular Pressure) changes of specific NSAIDs post SLT. Patients (n= 25, total 50 eyes) scheduled to undergo bilateral Selective Laser Trabeculoplasty (SLT) will instill bromfenac in the first eye to undergo SLT, and the contra lateral eye will receive nepafenac.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old, either gender or any race.
* Diagnosis of open-angle glaucoma or ocular hypertension requiring laser trabeculoplasty.
* Completion of written and informed consent/authorization prior to any study related procedures.
* Able to follow study protocol and likely to complete study schedule.

Exclusion Criteria:

* Known sensitivity to NSAIDs.
* History of neovascular or ocular inflammatory disease.
* Current use of topical or systemic anti-inflammatory medications.
* Females of childbearing potential.
Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout

D-0120 is being tested in combination with Allopurinol in adult subjects with Gout.


Eligibility Criteria:
Inclusion Criteria:

* Gout subjects meeting 2015 ACR/EULAR Gout Classification Criteria with inadequate urate-lowering response
* Subject has had at least 2 gout flares in the previous 12 months.
* Body Mass Index (BMI) between 18.0 and 45.0 kg/m2 (inclusive).
* Male and Female Subjects must agree to abstain or use effective contraception methods from the time of signing ICF and for the duration of study participation through 30 days after the last dose of study drug.
* Subjects must have adequate clinical laboratory and ECG results as assessed by the Principal Investigator

Exclusion Criteria:

* Subjects with significant comorbidities, inadequate lab function, current (and within the past 5 years) diagnosis of cancer or any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
* Women who are pregnant or breastfeeding
Role of Nitric Oxide in Optic Nerve Head Blood Flow Regulation During Experimental Increase of Intraocular Pressure in Healthy Humans

Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance to changes in perfusion pressure. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. Large scale studies have shown that reduced ocular perfusion pressure is an important risk factor for the prevalence, the incidence and the progression of primary open angle glaucoma.

Former studies that investigated ocular blood flow autoregulation focused mainly on choroidal blood flow. For the optic nerve head only few data are available, although it seems likely that it underlies similar autoregulatory mechanisms.

A previous study investigating choroidal blood flow has shown that nitric oxide (NO) plays a key role in choroidal autoregulation. The present study is designed to test the hypothesis that NO plays a role in optic nerve head autoregulation during increased intraocular pressure (IOP). Therefore, IOP will be experimentally increased using a suction cup device in the absence of presence of either a nitric oxide synthase inhibitor (L-NMMA), an α-receptor agonist (phenylephrine) or placebo. Optic nerve head blood flow will be continuously measured during the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years, nonsmokers
* Men and women will be included in equal parts
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal findings in the laboratory testings unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia less than 1 diopter

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug (except intake of oral contraceptives)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
* Pregnancy
Long-term Outcomes and Prognostic Factors in Patient Undergoing CABG or PCI

1. To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease undergoing coronary artery bypass graft surgery.
2. To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease undergoing percutaneous coronary intervention with drug-eluting stent.

Coronary artery disease (CAD) still remains one of the world's leading causes of death, despite markedly improvement of devices and technologies on past several decades. The treatment strategy for CAD included medical treatment, percutaneous coronary intervention (PCI), and coronary-artery bypass grafting (CABG). CABG is a procedure in which autologous arteries or veins are used as grafts to bypass coronary arteries that are partially or completely obstructed by atherosclerotic plaque. During the past decade, there has been nearly a 30% decline in CABG procedures, despite abundant evidence to support the effectiveness and safety of the operation.This decline has been accompanied by a corresponding increase in PCI. To date, there have been numerous studies to compare the clinical outcomes between PCI and CABG for patients with CAD. Among them, SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) trial demonstrated CABG is associated with lower incidence of major adverse cardiac and cerebrovascualr events in patients with high SYNTAX score, compared with PCI. In this regard, the current guidelines recommend that CABG is preferred method for care of stable ischemic heart disease patients with three-vessel or left main coronary artery disease. However, most randomized controlled studies do not reflect the contemporary practice, because they have been performed in the era of bare metal stents or first-generation drug-eluting stent (DES). In addition, there have been limited data regarding the prognostic factors for long-term clinical outcomes in patients undergoing PCI with DES or CABG. Therefore, the investigators sought to compare the clinical outcomes between PCI with DES or CABG, and to identify prognostic factors for long-term clinical outcomes in patients who underwent PCI with DES or CABG.

Eligibility Criteria:
Inclusion Criteria:

* Patients who suspected ischemic heart disease and underwent CABG or PCI with DES

Exclusion Criteria:

* Age \< 18 years
Study of a National Cohort of Adult Patients With Phenylketonuria

Phenylketonuria (PKU) is a metabolic disease of genetic origin. This is a rare disease (incidence 1 / 16000 births) which is the subject of a systematic neonatal screening in France, because it is treatable by a diet low in phenylalanine. This plan is required upon confirmation of diagnosis and continued until the age of 8 years. The current trend is to continue the scheme at least until adolescence. Unlike other countries, in France there are no recommendations for a plan "for life". Knowledge about the natural history of PKU in adulthood, the effects of pediatric age, the frequency of complicated shapes, and prognostic factors are poorly documented. On the other hand, there is no consensus on the therapeutic management of this disease in adulthood and monitoring that could be directed towards the detection of neurological disorders and nutrition. Social integration and quality of life of adults PKU patients living in France have not been studied.

The aim off this study is to follow a French cohort of young adult patients with PKU to:

* Describe the evolution of the disease in adulthood and neurological complications associated neuropsychological detect, investigate the prognostic factors for complications
* Describe the metabolic balance of patients
* Collect data on nutritional status,
* Detect osteoporosis
* Studying social integration and quality of life of adult patients with PKU
* Collect biological samples for further study (markers of bone turnover)

Design:

Cohort :

Duration of the inclusion period: 2 years Duration of subject participation: 5 years Total duration of the study: 7 years

JUDGING CRITERIA:

* Complications associated with PKU in adult
* Evolution of neuropsychometric scores
* Bone mineral density by densitometry
* Measuring the quality of life of patients

Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥ 18 years
* Phenylketonuria (PKU) or moderate persistent Hyperphenylalaninemia (HMP) diagnosed by neonatal screening
* Reading and signing an informed consent
* Membership of a social security system

Exclusion Criteria:

* History of severe neurological definite diagnosis could interfere with the detection of neurological disorders associated with PKU
Understanding How Alzheimer's Disease Impacts the Therapeutic Response to Transcranial Direct Current Stimulation

There is currently little symptomatic therapy for Alzheimer's Disease (AD) and nothing effective for individuals with Frontotemporal dementia (FTD). However, neuromodulation with transcranial direct current stimulation (tDCS) has the potential to be a clinically effective therapy for both AD and FTD. The challenge now is to specify the parameters and conditions under which tDCS is most effective to transition from the laboratory to clinical medicine. tDCS studies typically report significant group effects despite the variability demonstrated among participants, with some showing clear, meaningful improvement, while others only show statistical improvement or none at all. These variable results may be related to the conventional stimulation intensity level of 2mA. The investigators predict that administering tDCS at 4.0 mA, a more significant number of participants would show a meaningful response, and those who improve at 2mA may improve even more from 4.0mA due to having a larger electric field produced. The investigators aim to test this hypothesis in people with Alzheimer's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Mild to Moderate AD
* Score between 18 and 25 on the MoCA
* Able to do the N-Back task during the initial screening

Exclusion Criteria:

* No history of stroke or TBI
* No shunts or metal in the body
* No history of significant heart disease, alcoholism and drug use
Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors

Neurosurgery is a risk factor for delirium. Dexmedetomidine might reduce delirium by reducing neuroinflammation, improving postoperative analgesia and sleep quality. The the primary hypothesis is that perioperative administration of dexmedetomidine can reduce the incidence of postoperative delirium

The investigators will be required to attend the professional training before recruitment and strictly adhere to the study protocol. All the raw data will be recorded in the case report forms. Data will be entered doubly performed by two investigators and monitored securely in an electronic database with password protection at the medical center. The data base will be locked after all data have been cleaned. All the original fles will be maintained in storage for 5 years after completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with temporal glioma scheduled for a elective craniotomy
* Age ≥18 years
* Obtain written informed consent.

Exclusion Criteria:

* Patients with severe preoperative cognitive impairment
* History of traumatic brain injury or previous neurosurgery
* History of psychotropic medications
* Allergy to dexmedetomidine
* Pregnant or lactating women
* History of obstructive sleep apnoea syndrome
* Severe bradycardia(heart rate \<40 beats/min), sick sinus syndrome or second-to-third degree atrioventricular block
* Severe hepatic dysfunction
* Severe renal dysfunction
A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status

This multi-center, single-arm study evaluated the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide in participants with B-cell chronic lymphocytic leukemia (CLL) and favorable somatic status.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of previously untreated B-cell CLL confirmed immunophenotypically
* For participants, age 60-70 years: Cumulative Illness Rating Scale (CIRS) comorbidity score less than or equal to (\</=) 6
* Binet stage B, C or A with progression
* Life expectancy greater than or equal to (\>/=) 12 months
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* Women of child bearing potential and men should agree to use highly reliable contraceptive method throughout the treatment period and within 12 months after treatment completion

Exclusion Criteria:

* Participants with small-cell lymphoma
* Participants with auto-immune hemolytic anemia
* Concomitant malignant disease during enrollment, except basal cell carcinoma of the skin
* Chemotherapy for concomitant malignant disease given within 12 months prior to study enrollment
* Participants with Richter's Syndrome
* Participants with symptomatic Hepatitis B infection
* Any clinically significant infection that could not be cured prior to enrollment, including Human Immunodeficiency Virus (HIV) infection
* Creatinine clearance less than (\<) 30 milliliters per minute (mL/min)
* Participants with congestive heart failure (CHF) New York Heart Association (NYHA) III-IV
* Participants with liver failure and acute hepatitis of any etiology
* Any other medical or mental condition which may preclude from receiving the entire course of protocol specified treatment or signing the informed consent
* History of an anaphylactic reaction to murine antibodies, proteins, or any other ingredient of rituximab
* Pregnancy and breast-feeding women
Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy

Exploratory, prospective, interventional, non-randomized single-center research study to compare metrics derived from 2 or 3-D reconstructions of lead movement, bioimpedance and VCG to augmentation of left ventricular contractility (LV dP/dt max) at different pacing configurations in patients undergoing a CRT-implant. Pacing sites and contractility data will be compared to pre operative cardiac ultrasound and MRI metrics.


Eligibility Criteria:
Inclusion Criteria:

* Subject is indicated for CRT or CRT-D device according to current applicable ESC/AHA guidelines
* Subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting \> 30 seconds during the last 2 weeks prior to inclusion). No documented AF-episodes allowed during the last 2 weeks prior to inclusion.
* Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or ARB and Beta Blockers), and is on a stable medication scheme for at least 2 months prior to enrollment.
* Subject (or the legal guardian) is willing to sign informed consent form

Exclusion Criteria:

* Permanent atrial fibrillation/ flutter or tachycardia
* RBBB
* Recent myocardial infarction (MI), within 40 days prior to enrollment. Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days prior to enrollment
* Post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
* Implanted with a left ventricular assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year
* On chronic renal dialysis, or with severe renal disease (defined as estimated Glomerular Filtration Rate (equation provided by Modification of Diet in Renal Disease study): (eGFR) \< 30 mL/min/1.73m2)
* On continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions a week)
* Severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated on within study period)
* Complex and uncorrected congenital heart disease
* Mechanical heart valve
* Breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
* Enrolled in one or more concurrent studies that would confound the results of this study
* Already implanted with pacemaker (CRT, CRT-D, ICD) and needs replacement
Acute Exercise and Microvascular Function

It is well recognized that chronic exercise protects against the development of cardiovascular diseases. However, the responses of vasculature to acute exercise (AE) are not well known and not consistent in literature. Acute exertional exercise can induce large, transient increases in arterial pressure and development of metabolic acidosis which can be associated with pro-inflammatory response involving oxidant stress and circulating cytokines known to impair endothelial function.

The aim of this study is to test the impact of a single exposure to exhausting training on microvascular reactivity in healthy sedentary subjects and athletes.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* active athletes
* lean sedentary subjects

Exclusion Criteria:

* drugs that could affect the endothelium
* overweight
* hypertension
* coronary artery disease
* diabetes
* hyperlipidaemia
* renal impairment
* cerebrovascular and peripheral artery disease
Development of a Blended Lifestyle Intervention to Promote Physical Activity, Diet, and Health in Hong Kong Older Adults

This pilot study will provide a theory-based low-cost and easy-to-operate program in the area of healthy lifestyle promotion among community dwelling older adults. The blended intervention product will be helpful for health professionals, social workers and practitioners working in the elderly centers and health centers to promote older adults' PA, healthy diet and wellness. Furthermore, this study would initiate advocacy for policymakers to disseminate cost-saving, time-efficient and effective healthy lifestyle programs to the communities for healthy aging promotion.

Project Objectives

1. To review and meta-analyze lifestyle interventions for promotion of physical activity, diet and health among older adults.
2. To assess the feasibility of the pilot study.
3. To assess acceptability of the pilot study.
4. To examine between-group differences in changes of physical activity (min/week), diet (portion/day), physical health-related outcomes (physical fitness, blood pressure, fasting blood sugar, and blood lipids), mental health-related outcomes (depression, loneliness) and health-related quality of life (QoL) among the sample.

A series of generalized linear mixed models (GLMM) will be applied to evaluate the intervention effects on outcome measures at T2, with time, groups, and their interaction as fixed effects. Per-protocol analyses will be used for primary analyses, while intention-to-treat approach will be used for sensitivity tests.

Eligibility Criteria:
Inclusion Criteria:

* aged 65-79 years;
* have access to the internet and smartphone;
* speak Cantonese;
* pass the Physical Activity Readiness-Questionnaire (PAR-Q) screening or have the physician's approval prior to participation.

Exclusion Criteria:

* no cognitive disorders or impairments;
* unable to engage in physical activity;
Phase 1 Study for Safety and Tolerability of IL-1-Ra Topically Administered to Eyes of Healthy Adult Subjects

The purpose of this study is to assess the safety and tolerability of ocular administration of Topical Interleukin-1-Receptor Antagonist in healthy volunteers. Additionally, the PK of Interleukin-1-Receptor Antagonist will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males and/or females between the ages of 18 and 45 years
* Medically healthy
* Best correction vision of greater than or equal to 20/20 in each eye
* BMI ≥ 19 and \< 24 kg/m2
* Ability to understand and provide informed consent to participate in this study
* Willingness to follow study instructions and likely to complete all required visits

Exclusion Criteria:

* Any ocular or systemic diseases
* History of skin or ocular allergy symptoms
* Use contact lenses during the trails.
* Taking inhaled or oral steroids (for example Advair, Orapred)
* Have an active infection
* Have serologic evidence of HIV, Hepatitis C, Hepatitis C, or tuberculosis
* Receipt of any blood or blood products within 2 months prior to the first dosing day.
* Use any drugs within 2 weeks prior to the first dosing day.
* Use of cyclosporine, steroid eye drops, serum eye drops, or any other eye medication or experimental drug within the past 4 weeks.
* Have been exposed to an investigational drug/device within the preceding 3 months
* Pregnant or lactating females
* History of substance abuse, drug addiction or alcoholism
* Males and females unwilling to use an acceptable method of contraception for the duration of the study
SMART Study: A Study of Re-treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on Anti-TNF Alfa Therapy

This study will compare the efficacy and safety of re-treatment with 2 doses of MabThera (rituximab) in patients with active rheumatoid arthritis (RA) who have previously experienced an inadequate response or intolerance to anti-tumor necrosis factor (anti-TNF) therapies etanercept, infliximab or adalimumab therapy. All patients will receive infusions of 1000 mg intravenous (IV) MabThera on Days 1 and 15; at Week 24 patients who have demonstrated a moderate or good response will be randomized to receive re-treatment with either 1 or 2 additional infusions of 1000 mg IV MabThera. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>18 years of age
* RA for \>=6 months
* Receiving outpatient treatment
* Ongoing treatment with methotrexate for \>=3 months, stable for \>=1 month
* Inadequate response or intolerance to etanercept, infliximab or adalimumab

Exclusion Criteria:

* Previous treatment with MabThera
* Concurrent treatment with any anti TNF-alfa therapy or biologic therapy
* Previous treatment with any investigational cell-depleting therapies