cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis

The primary study objective is to evaluate medium- and long-term safety of HBM9161 in combination with background treatment for gMG patients through the observation on adverse events and laboratory abnormalities during study period.


Eligibility Criteria:
Inclusion Criteria:

1. Completed the HBM9161.3 Phase 3 study
2. Signed written informed consent.
3. Suitable for continued treatment with HBM9161 as judged by the investigator.
4. Female patients of childbearing potential and male patients with female partners of childbearing potential can participate in this study, but reliable contraceptive measures must be taken (such as physical barrier contraception (patients and their partners), contraceptive pills or patches, spermicide and barrier or intrauterine device). Up to 60 days after the last dose.
5. A negative urine pregnancy at baseline must be observed for women of childbearing age.

Exclusion Criteria:

1. Had received any other clinical study drug since the administration of the study drug in the 9161.3 Phase 3 study.
2. Females who are pregnant or lactating or planning to become pregnant during the study period, or females of childbearing potential who are not using an effective method of contraception.
Study of Endothelial Dysfunction in Systemic Lupus and Its Role in Heart Disease

Systemic Lupus Erythematosus is a relatively common autoimmune disease that affects mainly women.Cardiovascular disease as a result of accelerated atherosclerosis is a major cause of mortality and morbidity in SLE.Previous research has shown that 35-40% of patients with SLE have abnormalities of myocardial perfusion even when they have no coronary stenoses on coronary angiography. The reason for these frequent perfusion abnormalities in the absence of angiographically significant CAD remains uncertain, but could conceivably result from endothelial dysfunction. In SLE, coronary endothelial dysfunction could result from the inflammatory process involved in the SLE disease itself, a finding that could explain the correlation between disease activity and the development of CAD in these patients.As such endothelial dysfunction may account for accelerated atherosclerosis and cardiac perfusion defects (without angiographically significant coronary lesions). We propose to first evaluate whether endothelial dysfunction occurs in these patients and is more frequent in patients with myocardial perfusion abnormalities. Endothelial function will be assessed by measuring flow-mediated brachial artery dilatation. In the 250 patients included in the study we will correlate endothelial function and myocardial perfusion abnormalities to SLE disease activity, to its treatment and to the presence of CAD risk factors In a subgroup of patients (estimated 5 patients) in whom it is clinically indicated, coronary angiography will be performed in order to assess the presence of significant coronary stenoses (\>50%),coronary artery reserve and coronary endothelial dysfunction. We will then attempt to reverse abnormalities in endothelial function and myocardial perfusion by therapy with an ACE inhibitor(Quinapril).Patients with myocardial perfusion abnormalities will be randomised to receive Medication A(oral Quinapril or Placebo) for 8 weeks, will have all baseline investigations repeated and then will switch over and receive medication B(Quinapril or placebo) for a further 8 weeks followed by repeat investigations.


Eligibility Criteria:
Inclusion Criteria:

\>20 years Lupus according to ACR criteria Patients who demonstrate abnormality on mycardial perfusion imaging are eligible for treatment arm of study

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Exclusion Criteria:

Steroid dependent asthma known contraindication to dipyridamole known intolerance to or contraindication to use of ACE inhibitors history of angioedema serum creatinine. 200mmol/l Renal artery stenosis pregnant or breast feeding inability to perform low grade exercise presently taking ACE, ARB or nitrates
Acute Effects of AMPS on Cardiovascular, Functional Capacity and Postural Control in Patients With Parkinson's Disease

Considering that Parkinson's Disease (PD) can significantly compromise functional mobility and cardiovascular system in patients with PD, therapies aimed at improving these aspects, mainly by non-pharmacological and non-invasive methods, are paramount. This clinical trial will study the acute effects of plantar stimulation using a therapy called automated peripheral mechanical stimulation (AMPS) on cardiovascular and functional mobility in patients with PD.

The hypothesis of this study is that one single session will be effective in improving, acutely, the cardiovascular system and functional capacity in patients with PD.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of idiopathic Parkinson's disease
* Scoring 1 to 3 on the Hoehn and Yhar scale
* Pharmacological treatment unchanged for at least 30 days prior the study

Exclusion Criteria:

* Signs of cognitive decline, based on the results of the Mini Mental State Examination
* Cardiorespiratory, neuromuscular and musculoskeletal diseases not related to PD
* Sensory peripheral neuropathy, diabetes or any other disease known to promote autonomic dysfunction
Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation

Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the endoscopic ablation system in comparison to irrigated radiofrequency current ablation in patients with drug-refractory persistent atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years
* persistent atrial fibrillation
* failure of at least one antiarrhythmic drug
* others

Exclusion Criteria:

* contraindications for pulmonary vein isolation (PVI)
* previous PVI attempts
* inability to be treated with oral anticoagulation
* presence of intracardiac thrombi
* pregnancy
* others
Evaluation of Clinical Decision Support System-mPDia for Neurodegenerative Parkinsonism Using MRI Images

mPDia is a software that has been pre-learned based on a neurodegenerative parkinsonism diagnosis model using Nigrosome 1 MRI images, and clinical decision support system for diagnosing neurodegenerative parkinsonism by automatically analyzing Nigrosome 1 MRI images by assisting the medical team.

The specific aims of this study are to evaluate efficacy of mPDia for neurodegenerative Parkinsonism compared to the sensitivity and specificity levels of 18F FP-CIT PET/CT which is currently used to diagnose neurodegenerative parkinsonism.


Eligibility Criteria:
Inclusion Criteria(Normal cohort):

* Adults over 19 years old
* 3T nigrosome 1 MRI acquired
* 18F FP-CIT PET/CT are confirmed to be normal
* The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism

Inclusion Criteria(Abnormal cohort):

* Adults over 19 years old
* 3T nigrosome 1 MRI acquired
* 18F FP-CIT PET/CT are confirmed to be abnormal
* The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism

Exclusion Criteria:

* Patients with other brain diseases except parkinsonism
* Who have anatomical abnormality in MRIs etc.
* Who have other causes of tremor(e.g., thyroid disease)
* Patients with lesion in basal ganglia(e.g., vascular parkinsonism, hydrocephalus and Wilson's disease)
Randomized Trial of Financial Incentives to Reduce Sugar-sweetened Beverage Purchases by Low-income, Latino Families

Approximately 15% of the US population is enrolled in the Supplemental Nutrition Assistance Program (SNAP), and 50% are children. Although the goal is to improve nutritional health, preliminary data suggest that enrollment in SNAP is associated with obesity and metabolic risks and that SNAP reimburses $4 billion annually for sugar-sweetened beverages (SSBs). This pilot project tests an innovative strategy to reduce purchase of non-nutritive, SSBs by low-income families with children by combining targeted point-of-purchase education with a randomized trial of financial incentives to discourage purchase of unhealthy beverages. The study will take place at a mid-size grocery store that is located in a low-income, Latino community and where 30% of purchases are made with SNAP. Targeted beverage education will be provided to all study subjects with a traffic-light system to identify healthy and unhealthy beverages at the point-of-purchase. Individual beverage purchases will be tracked by electronically stored cash register sales. Supplementary validation of beverage consumption will be assessed by 24 hour dietary recall. Aim 1 is to conduct a randomized controlled trial to compare purchase and consumption of SSBs by families assigned to a financial incentive to reduce purchase of SSBs with families assigned to control (no incentives). Aim 2 is to compare the purchase of SSBs by families in both arms during the study period when they are exposed to the traffic-light system to a baseline period prior to traffic-light education. Results of this project will provide pilot data for larger scale interventions to promote healthy choices among low-income families.


Eligibility Criteria:
Inclusion Criteria:

* purchase \>75% of groceries at targeted supermarket (regular customer)
* at least one child \<= 18 years old living at home

Exclusion Criteria:

* not fluent in Spanish or English
* no address or phone for contact
Study of Obesity Control by Astragalus and Notoginseng Extrats

The effects of the Astragalus and Notoginseng extrats on obesity control was demonstrated in a randomized double-blind, and crossover human trial.

Obesity refers to the body due to physiological or biochemical function of the change caused by excessive accumulation of body fat, resulting in weight gain. Hence, the aim of this study was to evaluate the effects of the Astragalus and Notoginseng extrats on obesity control by a randomized double-blind and crossover human trial. Subjects with simple obesity (body mass index (BMI) ≥ 27 or body fat ≥ 30%) ingested 5 extrats (n = 19) capsules or placebo (n = 19) perday for 12 weeks of a stage. Anthropometric measurements (body weight, body fat, blood pressure) and blood biochemical markers including fasting blood glucose (FBG), albumin, total cholesterol (TC), triglyceride (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen (BUN), AST, ALT were examined every six weeks.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥ 27 or body fat ≥ 30%;
* No history of serious diseases associated with heart, liver, kidney, endocrine systems or other organs;
* No drugs consumption.

Exclusion Criteria:

* BMI \>35;
* Alcoholic;
* US-controlled diabetics;
* Stoke in past one year;
* High blood pressure;
* Mental diseases or melancholia;
* Pregency or breast-feeding a child.
Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing

Clopidogrel low response is associated with a significantly higher risk for ischemic complications after percutaneous coronary intervention. Ticagrelor and prasugrel are more potent platelet inhibitory drugs and both have been shown to significantly reduce ischemic events as compared to clopidogrel. No direct comparison between ticagrelor and prasugrel in terms of their antiplatelet efficacy exists. The aim of this study is to assess the antiplatelet treatment efficacy of ticagrelor versus prasugrel over time in confirmed clopidogrel low responders undergoing percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* successful PCI
* 600 mg clopidogrel pretreatment
* clopidogrel low response assessed with electrode aggregometry (\>= 486 AU\*min)
* written informed consent

Exclusion Criteria:

* Contraindications or allergies against study drugs
* Anemia
* Any surgery \< 6 weeks
* Increased bleeding risk
* Oral anticoagulation
* platelet count \< 100.000/µl
* Prior history of stroke or pathologic intracranial findings
* GPIIb/IIIa antagonists \< 10 days or periprocedural
* Age \> 80 years, \< 18 years
* Body weight \< 60 kg
* Cardiogenic shock
* Increased risk of bradycardia
* Moderate liver disease
* Kidney dialysis
* Intake of CYP 3A4 inhibitors
* Pregnancy or lactation
* Missing pregnancy test for women capable of bearing children
A Study of the Use of High-dose Proton Pump Inhibitor for the Treatment of Gastro-oesophageal Reflux Related Non-cardiac Chest Pain - a Randomized Double-blind Placebo-controlled Study

Non-cardiac chest pain accounts for 2-5% of all emergency presentations. In the United States, it has been estimated approximately that US$8 billion was spent annually for the initial care of patients suspected to have an acute coronary syndrome, but who were subsequently found not to have coronary artery disease (1). The most common cause of non-cardiac chest pain is gastro-oesophageal reflux disease (2). Two randomized, double-blind, placebo-controlled trials on the use of omeprazole versus placebo for the treatment of NCCP have been published in the western population and reported an efficacy of 62% to 80% (3,4). High-dose omeprazole was used in the previous trials (3,4). Recently, it has been shown that rabeprazole, which is a newly developed benzimidazole proton pump inhibitor, is a more potent and rapid inhibitor of H+,K+-ATPase and acid secretion than omeprazole, lansoprazole and pantoprazole (5,6). Whether the above findings applied to Chinese population is unknown. Thus we would like to propose a randomized double-blind placebo-controlled trial to study the effects of high-dose proton pump inhibitor for the treatment of non-cardiac chest pain in Chinese population. The aim of this study is to evaluate the efficacy of high-dose proton pump inhibitor for the treatment of gastro-oesophageal reflux related non-cardiac chest pain.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients with age over 18 years old
* Patients with chest pain for at least 12 weeks, in the preceding 12 months who are evaluated by cardiac catheterization or exercise radionuclide scan / persantin radionuclide scan will be assessed for suitability to enter the study. Patients will be included if the results of the cardiac investigation are normal.

Exclusion Criteria:

* Patients with history of significant cardiac, renal, pulmonary or hepatic diseases.
* Patients with history of gastrointestinal surgery or peptic ulcer diseases.
* Intake of H2 receptor blockers, bismuth or proton pump inhibitors or drugs affecting gastrointestinal motility in the preceding four weeks.
* Patients who are pregnant or lactating.
* Patients who are suffering from costochrondritis.
* Patients who are known to be sensitive to proton pump inhibitor.
* Patients with glaucoma and benign prostatic hypertrophy.
Chronic Obstructive Pulmonary Disease (COPD) Dual Therapy Burden of Illness

The main purpose of the study is to assess the burden of illness for, COPD using both patient-reported symptom burden and claims-based economic burden, among the subjects treated with single-inhaler dual therapy treatments, Fluticasone/Salmeterol FLUT/SAL; Advair) or Umeclidinium/Vilanterol (UMEC/VI; Anoro) to support Global Initiative for Chronic Lung Disease (GOLD) category B recommendations. The study will use a health plan recruitment strategy and subject's will be recruited using Optum's health plan recruitment strategy to collect information relating to the subject's condition history, current treatment, smoking history, symptoms and symptom severity (Modified Medical Research Council Dyspnoea Scale \[mMRC\] and COPD Assessment Test \[CAT\]), and demographic and sociodemographic characteristics. A total of 2700 subject's, are planned to be enrolled in the study to reach the target evaluable sample size, n=770 subjects. Following completion of data collection, results of the survey, will be merged with claims data, covering the 12-month Baseline period for analysis. Pharmacy and medical claims data, will be used to calculate all-cause and COPD-related health care utilization and costs, treatment patterns, and Baseline clinical characteristics. The study duration is estimated to be of 12-months.


Eligibility Criteria:
Inclusion Criteria:

* \>=2 International Statistical Classification of Diseases and Related Health Problems (ICD)-10-CM diagnosis codes for COPD at least 30 days apart during the 12 month period prior to sample identification.
* Diagnosis codes J40-J44 will be included.
* \>=1 pharmacy claim for UMEC/VI or FLUT/SAL single-inhaler dual therapy during Baseline.
* Age \>= 65 years.
* Self-reported health care provider diagnosis of COPD.
* Self-reported prescription for FLUT/SAL or UMEC/VI.
* 12 months of continuous enrollment during the Baseline period.
* Ability to complete the study survey in English.

Exclusion Criteria:

* \>=2 ICD-10-CM diagnosis codes for asthma at least 30 days apart during the, 12 month period, prior to sample identification.
* Claims for both UMEC/VI and FLUT/SAL in the 6 months, closest to sample identification.
* Claims for triple therapy (Inhaled Corticosteroid \[ICS\] + Long-acting Antimuscarinic \[LAMA\] + Long-acting Beta-agonist \[LABA\] during the Baseline period.
* Evidence of lung cancer diagnosis and/or treatment
Development of a Decision Aid to Facilitate Ovarian Cancer Patient's Choices Regarding Biomarker CA125

In 2015 the Danish Health authorities initiated major changes in the national follow-up (FU) program for ovarian cancer patients. The new FU program argues that there is no effect of routine monitoring of tumour marker CA125. Now every patient needs to choose if they wish routine measurement of CA 125 to be part of the follow-up program.

Shared Decision Making (SDM) can help health professionals develop a more individualized care plan in collaboration with the patient, as stated in the revised national FU program. Due to the complexity and challenges within ovarian cancer care, this is an evident area of focus.

SDM is defined as an approach in which the clinician and patient go through all phases of the decision-making process together and share the preference for treatment and reach an agreement on treatment choice. Clinicians have information about disease, tests and treatments, whereas patients hold information about their life circumstances, goals of life, and preferences for healthcare. SDM thereby offers a way of individualizing recommendations, according to patients' special needs and preferences. SDM has potential to give the patients a higher quality of healthcare by putting the patient in the center of care.

Decision aids (DA) are tools that can provide information and systematically describe the advantages and disadvantages of a specific intervention or monitoring, which can help patients become involved in decision making. Using evidence-based DA leads to improvement in knowledge, better understanding of screening, prevention and treatment options, and more accurate perception of risks for the patients.

All participants fill in a demographic and Decisional Conflict Scale questionnaire at baseline. After having been presented with the decision aid and made a choice as to CA125, the participants will complete the CollaboRATE and Decisional Conflict Scale questionnaire dealing with confidence as to the choice made and the level of shared decision making experienced. Six months later the Decision Regret Scale questionnaire is to be completed to reveal any regrets in relation to the CA125 decision.

For a preliminary investigation of the applicability of the DA, 15-20 patients not eligible for this study will be asked for their opinion.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age
* Histologically confirmed epithelial ovarian, fallopian tube or serous primary peritoneal cancer
* Have completed their first line treatment, with complete remission.
* Manage to read and speak Danish

Exclusion Criteria:

* Have recurrent disease after first line treatment
Closure of the Uterine Artery at Its Origin vs at the Cervix: a Randomized Trial

One of the fundamental surgical steps in patients undergoing laparoscopic hysterectomy is the closure of the uterine artery, this vessel provides the greatest blood supply to the uterus.

This step can be done in two ways: the surgeon can choose to interrupt the blood flow by closing the uterine artery in its last part, close to the uterus, or the surgeon can develop the anatomical spaces around the uterus into the deep pelvis, closing it to its origin, maintaining a minimally invasive approach in both cases.

Scientific research has tried to establish whether one of the two modalities is the best in reducing intraoperative blood loss and possible complications, but currently there is not enough evidence to recommend an approach rather than another.

The investigator has therefore decided to evaluate the results at the end of a laparoscopic hysterectomy in a scientifically rigorous manner.


Eligibility Criteria:
Inclusion Criteria:

* benign disease
* elective laparoscopic hysterectomy

Exclusion Criteria:

* malignant disease
* emergency laparoscopic hysterectomy
Object Finder for a Retinal Prosthesis

The proposed project seeks to provide object recognition as a feature in a retinal implant system. Participants will be able to direct an object recognition application to find a desired object in the field of view of the head-mounted camera, and to direct the participant's view towards it through the presentation of a recognizable icon. A prototype system will be developed and evaluated in human subjects in phase I. A full system implementation and a second phase of the trial will be completed in phase II.

The investigators propose to add an object-finding feature to a retinal prosthesis system. To use this feature, the participant will enable a special mode and input the desired object from a set of pre-programmed object types. Imagery from the visible light camera in the system eyeglasses will be processed using object recognition software as the participant scans their head across the room scene. When the object is identified in the scene by the processor, a flashing icon will be output to the epiretinal array in the appropriate position to guide the participant to the physical location of the object. Once located, the system will track the location of the object.

There will be two phases to the human subjects evaluation, each run initially through simulations in sighted human subjects, followed by tests in Argus II participants. In phase 1, system evaluation in human subjects at Johns Hopkins UNiversity (JHU) will explore performance in representative tasks and compare prosthetic visual performance without and with the new object finding feature. An important aspect of the evaluation will be the comparison of different icons and presentation modes to assist participants in locating and reaching objects. In phase 2, the system will be integrated into the Argus II video processing unit (VPU), and JHU will conduct human trials that include functional testing of the integrated prototype in representative environments and optimizing the ergonomics of the system, e.g. simultaneous finding and tracking of multiple objects/icons.

Eligibility Criteria:
Inclusion Criteria:

* For healthy volunteers: Vision corrected to 20/25, good general health
* For retinitis pigmentosa (RP) patients: End-stage retinitis pigmentosa, recipient of an Argus II retinal prosthesis system

Exclusion Criteria:

* None