cyrilzakka/clinical-trials huggingface dataset:
Safety Study of 89Zr-Anti-CLDN18.2 mAbs PET Imaging in Patients With CLDN18.2 Positive Solid Tumors

This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled anti-CLDN18.2 mAbs (89Zr-NY005) PET imaging in patients with CLDN18.2 positive solid tumors.

After being fully informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of anti-CLDN18.2 mAbs(89Zr-NY005) and will undergo PET/CT scanning to determine uptake of 89Zr-NY005 in tumor lesions and normal tissues and organs.

Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily signed informed consent, and be able to complete the trial according to the requirement of the scheme;
2. Aged 18-80, male or female;
3. The clinical diagnosis was gastric cancer, esophageal cancer and pancreatic cancer;
4. Patients with biopsy-proven CLDN18.2 positive;
5. Patients diagnosed with solid tumors confirmed by histopathology or cytology test;
6. At least two measurable solid lesions has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
7. ECOG score ≤ 0\~3; Life expectancy of at least 3 months;
8. ALT, AST shall not exceed 3 times of the normal upper limit; Bun, Cr not exceed 1.5 times of the normal upper limit.
9. Other routine examinations are within the normal range or considered acceptable by the researchers.

Exclusion Criteria:

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
3. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
4. Patients with autoimmune diseases, including rheumatoid arthritis;
5. Inadequate control of arrhythmias, including atrial fibrillation;
6. Uncontrolled hypertension;
7. Patients with allergies or allergies to any component of the imaging agent or antibody;
8. Patients who cannot undergo PET/CT imaging scan;
9. Syphilis, HBV, HCV, or HIV positive subjects;
10. Male and female subjects of reproductive age cannot take effective contraceptive measures;
11. Pregnant or lactating women;
12. Patients with a history of mental illness or related conditions;
13. Other subjects considered unsuitable by researchers.
Ophthalmic Artery Resistance Index After Peribulbar Block in the Presence of Epinephrine

Evaluate ophthalmic artery flow by echo-Doppler before and after peribulbar block with lidocaine in presence or absence of epinephrine.

There are controversies regarding the ophthalmic artery (OA) flow after peribulbar block with the addition of epinephrine. Therefore, we aimed to evaluate OA flow by echo-Doppler before and after peribulbar block with lidocaine in presence or absence of epinephrine.

Fifty-six patients that were eligible for cataract phacoemulsification surgery were selected. Patients were divided into two groups: group 1 - Peribulbar block with lidocaine and 1/200.000 epinephrine; group 2 - Peribulbar block with lidocaine in the absence of epinephrine. The resistance index (RI) of OA was evaluated using echo-Doppler before and 10 min after the peribulbar block.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I, II or III physical status classification
* Cataract surgery

Exclusion Criteria:

* glaucoma
* diabetic retinopathy
* previous eye surgery in the same eye
* ocular trauma
* allergic to any protocol medication
* uncooperative patients or cognitive difficulties
* axial eye diameter of less than 21.0 mm or greater than 25.5 mm.
Bilateral, Masked Comparison of PEG-400 Based Artificial Tear vs. Systane for Dry Eye Signs, Symptoms & Refractive Regression Associated With Myopic Laser in Situ Keratomilieusis (LASIK).

This study will evaluate and compare 2 artificial tears in their ability to reduce post LASIK dry eye signs and symptoms. The secondary endpoint of this study is to evaluate refractive regression in these patients. The 'Refractive Outcome' data point will be defined as the difference between the post-op spherical equivalent (SE) and the pre-op targeted SE.


Eligibility Criteria:
Inclusion Criteria:

* Patients ranging from normal to mild dry eye per physician assessment
* BCVA of 20/20
* Moderate to high myopia (-3 D to -10D of sphere)
* Patients who are scheduled to under go myopic bilateral LASIK with VISX laser

Exclusion Criteria:

* Patients currently using topical cyclosporine
* Patients currently using Systane
* Patients currently using an oil-based artificial tear such as Soothe or Endura
* Any post-op epithelial defects or flap complications requiring further procedures (relifting, scraping, stretching etc.)
* DLK greater than stage 1 or infectious keratitis post-operatively
* Any uncontrolled systemic disease that may confound the results of this trial (Diabetes, Lupus, Rheumatoid Arthritis etc.)
* Anisometropia greater than 1D
S-33 SMR Shoulder HP Reverse Glenosphere

Study Design: Single arm, retrospective and prospective, single center, post-market clinical study Purpose:To demonstrate the safety and effectiveness of the SMR Reverse HP Shoulder System device for primary, fracture or revision total shoulder replacement out to 24 months. The eligible study population is the entire population that underwent a reverse shoulder arthroplasty performed with 36-mm CoCrMo versus 40-mm cross-linked UHMWPE glenospheres between January 1, 2013 and January 1, 2020 at Wrightington Hospital (UK) in accordance with the indication for use of the product.


Eligibility Criteria:
Inclusion Criteria:

1. Patient was treated with the SMR Reverse Shoulder System device (either with 36-mm CoCrMo glenosphere or 40-mm cross-linked UHMWPE glenosphere) between January 1, 2013 and January 1, 2020 as per Instruction for Use
2. Patient was an adult male or female and was 18 years of age or older at the time of surgery
3. Patient received the SMR Reverse Shoulder System for primary, fracture, or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthroplasty
4. The patient's joint was anatomically and structurally suited to receive the selected implants, with a functional deltoid muscle
5. Surgery date is at least 24 months from screening of data
6. Patient has baseline radiographs and Oxford Shoulder Score

Exclusion Criteria:

1 Patient was treated with the SMR Reverse Shoulder System device (either with 36-mm CoCrMo glenosphere or 40-mm cross-linked UHMWPE glenosphere) between January 1, 2013 and January 1, 2020 out of the Indications for Use
Minimal Invasiveness of Endoscopic Thyroidectomy

The investigators had performed more than 250 cases of breast approach endoscopic thyroidectomy (BAET). The goal of this study is to evaluate whether BAET could be a minimally invasive procedure under the expert's hands.


Eligibility Criteria:
Inclusion Criteria:

* thyroidectomy nodule diagnosed by ultrasound

Exclusion Criteria:

* thyroid carcinoma
Early RA MRI Early Intensive Treatment Study

To compare the effectiveness of two treatment strategies in early rheumatoid arthritis (ERA), namely the delayed usual care and early intensive care, in Hong Kong.

* The delayed usual care reflects the usual treatment practice in Hong Kong
* The early intensive care includes tight monitoring and immediate adjustment of therapy

This study is a 1-year non-randomized clinical trial. Two groups of patients (delayed usual care and early intensive care) with diagnosis of rheumatoid arthritis (RA) and with symptoms onset of less than 2 years and disease modifying anti-rheumatic drugs (DMARDs) naive will be recruited. Remission is reached if patients fulfill the Boolean criteria.

Eligibility Criteria:
Inclusion Criteria:

For usual care group:

* patients with at least 1 tender and swollen joint
* duration of symptoms less than 2 years
* no previous use of DMARDs

For intensive care group:

* patients with at least 1 tender and swollen joint
* duration of symptoms less than 2 years
* no previous use of DMARDs
* patients who fulfill the 2010 ACR/EULAR classification criteria for RA

Exclusion Criteria:

* patients with renal impairment (on dialysis or estimated Glomerular Filtration Rate (eGFR) \<30 mL/min/1.73m\^2)
GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)

In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.


Eligibility Criteria:
Inclusion criteria:

1. Age =\>18 years at enrollment
2. Male or female patient (or legally acceptable representative) willing and able to provide written informed consent
3. Patient newly diagnosed (\< 3 months prior to baseline visit) with non-valvular AF and at risk for stroke.

Other inclusion criteria apply.

Exclusion criteria:

1. Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;
2. Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime;
3. AF with a generally reversible cause;
4. Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a VKA) is indicated Other exclusion criteria apply
MK3207 for Treatment of Acute Migraines (3207-005)

The purpose of the study is to demonstrate the effectiveness and appropriate dosage level of MK3207 in the treatment of acute migraine.


Eligibility Criteria:
Inclusion Criteria:

* Men and Women from 18 to 65 years of age
* 1+ year history of migraine that typically last from 4 to 72 hours if untreated
* Had from 2 to 8 moderate or severe migraine attacks per month in the last 2 months
* Not pregnant or planning to become pregnant in next 6 months

Exclusion Criteria:

* Pregnant or breast-feeding, or planning to become pregnant in next 6 months
* Cannot distinguish migraine attacks from tension type headaches
* Migraines are mild or resolve without medication in less than 2 hours
* More than 15 headache-days per month or have taken medication on more than 10 days per month in the last 3 months
* Basilar type or hemiplegic migraine headaches
* More than 50 years old when migraines began
* History of cardiovascular disorder within last 6 months
Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary Fibrosis

The objective of the study is to evaluate the safety and efficacy of etanercept in comparison with placebo in a double-blind, parallel, randomized fashion in subjects with idiopathic pulmonary fibrosis (IPF) who failed previous therapy. The treatment period will be up to 1 year. The primary objective is evaluation of safety and efficacy. Secondary: The secondary objective is to evaluate quality of life (QoL) and pharmacokinetics (PK).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IPF based on American Thoracic Society (ATS) guidelines

Exclusion Criteria:

* Subjects with end-stage
* Previous treatment with etanercept or other TNF antagonists (eg, a TNF monoclonal antibody or a soluble TNF-receptor)
* Receipt of any investigational drug or biological agent within 4 weeks of screening visit
Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic Solution with Placebo when applied topically in subjects with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* best corrected visual acuity in both eyes of at least +0.7
* six-month documented history of dry eye disease
* at least mild severity in 2 of the 4 dry eye symptoms
* unanesthetized Schirmer score of less than or equal to 7mm
* corneal fluorescein staining of greater than or equal to 4 (out of 15)

Exclusion Criteria:

* nasally stimulated Schirmer score of less than 3mm in subjects with an initial Schirmer score of 0mm
* ongoing contact lens wear
* current topical ophthalmic medication use
A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting

To assess the efficacy and safety of Tygacil in the usual German hospital setting. The main goals are: to assess the efficacy of Tygacil under usual care conditions (cure rate); to assess the main side effects observed in daily medical practice (Safety of Tygacil); to determine whether patients are optimally dosed with Tygacil (according to the label) and the proportion of patients receiving a monotherapy versus combination therapy; to observe the potential resistance development against Tygacil in Germany; to determine which antibiotic agents are chosen for a combination therapy with Tygacil; to determine to which antibiotic substance non-responders to Tygacil are switched; to assess the duration of the intravenous therapy with Tygacil and to determine whether and which patients receive an oral antibiotic substance after the therapy with Tygacil; to collect information on profile, comorbidities and characteristics of patients treated with Tygacil.

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.

Eligibility Criteria:
Inclusion Criteria:

* Actual or planned therapy with tigecycline.
* At least 18 years old.

Exclusion Criteria:

* Hypersensitivity to antibiotics or tigecycline.
Imaging of Lymphatic Anomalies

Lymphatic Anomalies (LA) is characterized by proliferation of lymphatic tissue causing deterioration of pulmonary function. Understanding changes in lymphatic anatomy in these patients is hindered by the difficulty of imaging the lymphatic system. Dynamic Contrast Enhanced MR Lymphangiogram (DCMRL) may be useful in investigating pathological changes in the lymphatic system.

Lymphatic anomalies (LA) are a spectrum of rare diseases classified into lymphatic tumors and malformations. Complicated LA cases in the past have been called lymphangiomatosis because of varied disseminated involvement including soft tissue and viscera such as the spleen, liver and bone. Pleural effusions and pericardial effusions are often associated with these lesions. These are now classified into different phenotypes such as Generalized Lymphatic Anomaly (GLA), Gorham's Stout Disease (GSD) and Kaposiform Lymphangiomatosis (KLA). These complicated phenotypes can cause massive osteolysis causing a morbidity and mortality from infection or paralysis or worsening pulmonary function and effusions (GSD, GLA, KLA).

The major cause of mortality and morbidity in these patients is the deterioration of pulmonary function by chronic chylous effusions and progressive interstitial lung disease. Unfortunately, little is known about biomarkers, risk stratification or the pathophysiology of this progression. The understanding of changes in patients' lymphatic anatomy with LA is hindered by the difficulty of imaging the lymphatic system. Dynamic Contrast Enhanced MR Lymphangiogram (DCMRL) is a technique that has recently been developed, allowing dynamic MR imaging of the lymphatic system by injecting gadolinium contrast agent in the groin lymph nodes.

This technique has been previously used to identify pathological lymphatic perfusion of the lung parenchyma in patients with plastic bronchitis and neonatal chylothorax. Based on these imaging findings, a treatment algorithm has been designed and used to successfully treat the majority of those patients with these conditions.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with Lymphatic Anomalies (GLA, KL, Gorham disease) with radiological and or pathological confirmation of lung involvement will be considered for the study.
* Girls \> 11 y.o. with a negative urine pregnancy test and contraception use.
* Registration in the International Lymphangiomatosis and Gorham's Disease Alliance (LGDA) Patient Registry or referral by a physician.

Exclusion Criteria:

* Subjects with contraindications to contrast enhanced MRI: allergy to gadolinium imaging agents, impaired renal function (GFR\<30) and presence of paramagnetic objects.
* Claustrophobia or contraindications to sedation/anesthesia
* Uncorrectable coagulopathy (bleeding disorders).
* Pregnant or lactating females.
Death Following Congenital Heart Surgery

The purpose of this study is to elucidate the patterns of death following congenital heart surgery.

With the improvements in instrumentation, surgical technique, and critical care, the overall mortality following congenital heart surgery has become extremely low. Also, with the introduction of extracorporeal support (ECMO), especially in the emergency setting, acute deaths are extremely rare. The majority of post-operative deaths seem to be the result of a prolonged hospitalization with a progressive decline to multi-system organ failure.

The primary aim of the study is to elucidate the patterns of death following congenital heart surgery. The secondary aims of the study are to discover patterns and consistencies among the deaths and to discover points of potential intervention to reduce surgical mortality. The study will be conducted through a retrospective chart review of approximately 40 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the congenital surgery database
* Post-operative surgical mortality
* Deaths within 30 days of surgery
* Deaths prior to ever leaving the hospital
Dose Response of Exercise for Arthritis Management

The purpose of the study is to see examine the effects of 3 different levels of physical activity (45 minutes/week, 90 minutes/week, or 150 minutes/week) on arthritis symptoms.

All participants will be randomly assigned a physical activity goal (45 min/week, 90 min/week, or 150 min/week). To help participants achieve goals, they will receive a 6 month program which includes the Arthritis Foundation's Walk With Ease Guidebook, behavioral lessons, a Fitbit, and monthly coaching calls. Participants may also receive additional calls, texts, or emails if they are struggling to meet their physical activity goals.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Have a doctor diagnosed form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia
* Ability to read and write in English

Exclusion Criteria:

* Have any contraindications to exercise (besides arthritis)
* Engage in ≥30 min/week of Actigraph assessed MVPA
* Are pregnant, breastfeeding, or planning to become pregnant in the next year
* Are planning to relocate out of the Columbia, SC area in the next 12 months,
* Do not have a device compatible with Fitbit
* Have uncontrolled hypertension (e.g., systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg)
* Plan to have a surgery that affects mobility in the next 12 months
* Have a serious cognitive impairment.
* Not willing to be randomized to any of the 3 conditions, do not believe they could adhere to the goals, or do not believe they could achieve the highest dose of activity (150 minutes/week).
Prognostic Value of Lymph Node Dissection in Patients With Transitional Cell Carcinoma of the Upper Urinary Tract

Recent studies showed the therapeutic benefit of lymphadenectomy in advanced stage urothelial carcinoma of the upper urinary tract, but there is still a lack of prospective studies. Thus, the current guideline recommends lymph node dissection for invasive upper tract urothelial carcinoma (UTUC) on the basis of insufficient evidence. Also, the preoperative judgment of muscle invasive pathological stage T 2+,or N+ is difficult from preoperative imaging. In the investigators' clinical practice, the surgeons performed dissection of regional lymph nodes only in patients with enlargement of lymph nodes found in preoperative imaging or during surgery. The aim of this multi-institutional study was to examine the role of lymphadenectomy in urothelial carcinoma of the upper urinary tract.


Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed with upper tract urothelial carcinoma
* have no distant metastasis
* have an Eastern Cooperative Oncology Group (ECOG) score 0 to 2
* expected to receive radical nephroureterectomy

Exclusion Criteria:

* a prior history of bladder cancer
* administration of neoadjuvant chemotherapy
* deny to receive long term follow-up
* patients with contralateral UTUCs
* patients with synchronous muscle invasive bladder cancer
A Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair

The objective of this study is to evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.

This is a randomized, multi-center controlled study evaluating the effectiveness of EVICEL\* as an adjunct to sutured dural closure compared to control to obtain an intraoperative watertight dural closure.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing elective craniotomy/craniectomy
* Age greater than or equal to 18 years
* Patients who are able and willing to comply with the procedures required by the protocol.
* Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-related procedures.

Exclusion Criteria:

* Chemotherapy or radiation therapy within 7 days following surgery.
* Conditions compromising the immune system.
* Known hypersensitivity to the components (human fibrinogen, arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, human thrombin, human albumin, mannitol and sodium acetate) of the investigational product.
* Female subjects of childbearing potential with a positive pregnancy test prior to surgery.
* Female subjects who are breastfeeding or intend to become pregnant during the clinical study period.
* Participation in another clinical trial with exposure to another investigational drug or device within 30 days prior to enrollment.
* Major intraoperative findings or complications identified by the surgeon that may preclude conduct of the planned surgical procedure.
Diagnostic Yield of 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions

This study aims to examine technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in solid lesions by comparing with 22-gauge Procore needle. The study design is prospective, randomized study.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 20 years referred to our medical center for EUS-FNB with diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies.

Exclusion Criteria:

* cystic pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy (international normalized ratio \[INR\] \> 1.5 or platelet count \< 50,000 cells/cubic millimeter \[cmm3\]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability or refusal to give informed consent, and refusal to participate in the study.