cyrilzakka/clinical-trials huggingface dataset:
Clinical Outcomes of Clareon Vivity Intraocular Lens With Mini-Monovision Approach

Purpose is to study the clinical outcomes of Clareon Vivity and Clareon Vivity Toric intraocular lens (IOL) implants in patients who are planning to have cataract surgery in both eyes with a mini-monovision approach.

A "mini-monovision" approach is one in which the dominant eye is corrected for distance vision while the non-dominant eye is corrected with a small amount of nearsightedness (-0.5 diopters). This approach can have the benefit of increasing ability to see over a broad range of vision without glasses. The Clareon Vivity and Vivity Toric lenses have been approved by the U.S. Food and Drug Administration (FDA) for visual correction of aphakia in adult patients following cataract surgery. It has lens technology that provides an extended depth of focus (more range of clear vision for distance, intermediate and near vision) compared to a standard monofocal (single focus) lens. None of the procedures in this study are experimental. However, the study is seeking additional information on clinical outcomes of the mini-monovision approach specifically using the Clareon Vivity and Vivity Toric lenses.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with bilateral age-related visually significant cataracts in otherwise healthy eyes, undergoing bilateral sequential implantation within 21 days using Clareon Vivity and Clareon Vivity Torics
* IOL powers between +10D to +30.0D, T3-T6
* Potential acuity measured post-operatively 20/25 or better in both eyes

Exclusion Criteria:

* History of ocular or refractive surgery
* Ocular or systemic comorbidities that may alter or reduce visual acuity, contrast sensitivity, binocularity, or impair reading performance such as severe dry eye/ocular surface disease, glaucoma, macular degeneration, retinopathy, neuro-ophthalmic diseases, strabismus/amblyopia etc.
* Patients with irregular astigmatism, corneal dystrophies, pupil abnormalities, zonular laxity
* Intraoperative or postoperative complications
BTC Neuropsychological Database

Purpose and Objective:

The purpose of this study is to collect data both retrospectively and prospectively, by consent, on subjects seen in the PRTBTC. This information will be useful to the investigators to generate hypotheses for planning further psychosocial and medication intervention studies that will hopefully improve primary brain tumor patients' QOL.

Study Activities and Population Group:

Retrospective dates will be 3/1/06 through the approval date for the prospective component of this study. The data will be neurocognitive, depression, tumor-related, overall quality of life (QOL), treatment, and demographic variables. The investigators research aims are to

* compute correlations among these different variables
* to test significant predictors of QOL. The investigators also will conduct a retrospective review of all brain tumor patients evaluated at the neuropsychology clinic at the PRT-BTC from the date that this prospective study is approved back to 3/20/2006.

Data Analysis and Risk/Safety Issues:

The medical record review does not present any obvious source of risk or discomfort to patients and their families. For both the retrospective and prospective components of the study, as the data for the proposed study were already collected as a part of the standard of care at the Preston Robert Tisch Brain Tumor Center at Duke, there are no additional risks to the study sample as a result of data collection.

Eligibility Criteria:
Inclusion Criteria:

* Data collected both retrospectively and prospectively, by consent, on subjects with brain tumors seen in the Preston Robert Tisch Brain Tumor Center (PRTBTC).
* Retrospective dates will be 3/1/06 through the approval date for the prospective component of this study.

Exclusion Criteria:

* N/A
Esophagogastric Histopathology Potentially Guided Patients Younger Than 50 Years Old to Undergo Colonoscopy Earlier

Colorectal cancer (CRC) is the third most diagnosed cancer worldwide and second leading cause of cancer death. Most CRCs arise from a polyp, developing through two major precursor lesion pathways: the traditional adenoma-carcinoma pathway, and the serrated neoplasia pathway. This provides opportunities to prevent cancer by removing its precursor lesions. CRC screening efforts are directed toward removal of precancerous polyps with colonoscopy and detection of early-stage CRC, which has been demonstrated to reduce CRC incidence and mortality effectively, making CRC one of the most preventable and treatable forms of cancer.

Current guidelines in China recommend starting CRC screening uniformly at age 50 in average-risk individuals. However, a one-fits-all approach to determining CRC screening starting age may be not conducive to personalized screening, especially in the developing countries with scarce health resources. The incidence of early-onset CRC (CRC diagnosed before the age of 50) has shown a continuous increasing trend worldwide, spurring the US Preventive Services Task Force to recommend initiating average-risk CRC screening at age 45 instead of 50. Furthermore, different populations may benefit from even earlier screening, and CRC incidence may differ on the basis of population characteristics and CRC risk factors. For individuals younger than 50 years old, earlier screening based on risk factors may address this concern.

Previous studies have recommended earlier starting age of CRC screening combined with risk factors such as but not limited to sex, age, family history, lifestyle and comorbidity. Some upper gastrointestinal diseases have also been reported to be associated with an increased risk of colorectal neoplasms, which may be related to the destruction of gastric acid barrier function and long-term use of pump proton inhibitors. Compared with colonoscopy examination, individuals were more willing to undergo esophagogastroduodenoscopy (EGD) examination for gastric cancer screening, especially among the younger, potentially utilizing the EGD to guide earlier colonoscopies for patients at increased risk. Therefore, this study was aimed to investigate the association between esophagogastric histopathology and colorectal neoplasms in patients under the age of 50 and whether these risks factor could be combined with to guide earlier CRC screening.


Eligibility Criteria:
Inclusion Criteria:

Patients younger than 50 years old who underwent gastroscopy and colonoscopy simultaneously.

Exclusion Criteria:

1. Patients without a good bowel preparation (Boston Bowel Preparation Scale \[BBPS\] score ≥ 6);
2. Incomplete gastroscopy or colonoscopy examinations;
3. Partial or total gastrointestinal resection;
4. Patients who have been diagnosed with gastrointestinal cancer before endoscopy;
5. Hereditary polyposis, including Peutz-Jeghers syndrome, and familial adenomatous polyposis;
6. A history of inflammatory bowel diseases.
Efficacy and Safety Study of Catheter Ablation for Atrial Fibrillation

To compare the efficacy of different procedures, identify the optimal procedure, ablation sites, ablation endpoints and post-operative anticoagulation strategy, establish the optimal treatment strategy for atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

1. Atrial fibrillation recorded by ECG or Holter;
2. Age: 18 \~ 75 years;
3. Patients who are willing to enroll in the trial

Exclusion Criteria:

1. Patients accompanied hyperthyroidism;
2. Patients with sever liver or renal dysfunction;
3. Patients with sever cardiac dysfunction;
4. Patients had previous radiofrequency catheter ablation in the LA or Maze surgical procedure;
5. Patients with emboli in atrium;
6. Pregnant woman
A Clinical Study of Xin'an Medicine in the Treatment of Bi Syndrome

Bi Syndrome is one of Traditional Chinese Medicine（TCM）name, It means an obstruction in Chinese,and it refers the syndrome characterized by the obstruction of qi and blood in the meridians due to the invasion of external pathogenic wind,cold and dampness, manifested as soreness, pain, numb,etc. Bi Syndrome contains Rheumatoid arthritis(RA). RA is a chronic disease affecting more than 20 million people in the world.It is one of the most common forms of autoimmune disease. Xin'an Medicine is one of Traditional Chinese Medicine which originated from AnHui. Xinfeng Capsule developed according to the Xin'an medicine theory ,and it has long been adopted for treatment of rheumatoid arthritis (RA). The study is aimed to evaluate the effectiveness and safety of Xinfeng Capsule in the treatment of RA.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA, classified by American Rheumatism Association 1987 revised criteria.
* According with the Zheng diagnosis of Traditional Chinese Medicine.
* age from 18 to 65 years.
* For patients currently receiving non-steroidal anti-inflammatory drugs (NSAIDs): Treatment at a stable dose during last 4 weeks prior to screening，or Patients do not take NSAIDs at least 1 weeks prior to screening.
* Patients not taking DMARDs at least 4 weeks prior to screening.
* Patients taking corticosteroids (≤15mg prednisone or Equivalent) ≥4 weeks before entering the trial.
* Patients agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

* Patients have received intra-articular or systemic corticosteroid injection within 4 weeks of screening.
* Patients have high disease activity (DAS28-3 scores\> 5.1).
* Patients have diagnosed any other chronic inflammatory disease or connective tissue disease like sicca syndrome（SS）, systemic lupus erythematosus (SLE)etc;
* Patients with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system ;
* Patients who are pregnant or nursing mothers or Psychiatric patients.
* Patients with active gastroduodenal ulcer or gastritis which caused by long-term use of NSAIDs;
* The patient who has known hypersensitivity to trial medicine .
* Patients have participated in other clinical trials within 4 weeks of screening.
TIPE2 Associated With Kidney Transplant

TIPE2, a negative regulator of innate and adaptive immunity that maintains immune homeostasis. The investigators want to know whether TIPE2 is a risk factor for graft loss and gives rise to the immune dysfunction in renal transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* long-term surival(\>5year),AR and CR kidney transplant patients and healty Volunteers as control

Exclusion Criteria:

* without hepatitis , tumor and infections
Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors

The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors.

The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas.

Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule).

Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses.

Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses.


Eligibility Criteria:
Inclusion Criteria:

* Availability of tumor tissue for mesothelin expression testing and for further biomarker analysis
* Histologically-confirmed, mesothelin-expressing metastatic or advanced non-metastatic disease (tumour type specific inclusion criteria)
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (or for thymic carcinoma, at least one measurable lesion per International Thymic Malignancy Interest Group (ITMIG) modified RECIST 1.1 criteria
* Adequate bone marrow, liver, renal and coagulation function
* Left ventricular ejection fraction (LVEF) ≥ 50% of the lower limit of normal (LLN) according to local institutional ranges
* Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria:

* Exposure to more than one prior anti-tubulin/microtubule agent
* Corneal epitheliopathy or any eye disorder that may predispose the patients to this condition
* Symptomatic Central nervous system (CNS) metastases and/or carcinomatous meningitis
* Contraindication to both CT and MRI contrast agents
* Active hepatitis B or C infection
* Pregnant or breast-feeding patients
* Tumor type specific exclusion criteria
Intra-surgical Evaluation of CATS Tonometer Prism and Abbott Medical Optics Versus Alcon Phacoemulsification Machines

This study will measure the dynamic real-time intraocular pressure (IOP) in the anterior chamber during standard phacoemulsification surgery.

What is known:

* Fluidics control is determined to be one of the primary drivers of physician decision making in choosing phacoemulsification equipment.
* Active pressure system fluidic control has a perceived and possibly real (based upon recent literature) improvement in intra-cameral IOP stability and reduced pressure fluctuations.
* Improved fluidics can allow for reduced dynamic IOP fluctuations, in-the-bag positioned phaco tip, and intra-cameral fluid flow all of which will likely improve corneal health post-operatively.


Eligibility Criteria:
Inclusion Criteria:

* • Age 18 or greater

  * Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
  * Subjects able to give informed consent
  * Nuclear Sclerotic cataract graded 2+ or 3+
  * Naturally dilated pupil size (in dim light) \> 4.0 mm (with no dilation medications) for both eyes
  * Preoperative corneal astigmatism of 2.5 D or less
  * Ages between 55 and 80
  * Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

* • Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk

  * Intraoperative complications
  * Subjects with only one functional eye
  * Those with one eye having poor or eccentric fixation
  * Mild or severe cataracts, predominantly posterior subcapsular cataracts
  * High corneal astigmatism (i.e. those eyes displaying an oval contact image)
  * Those with corneal scarring or who have had corneal surgery including corneal laser surgery
  * Microphthalmos
  * Buphthalmos
  * Severe Dry eyes
  * Blepharospasm
  * Nystagmus
  * Keratoconus
  * Any other corneal or conjunctival pathology or infection.
  * Central corneal thickness greater than 0,600 mm or less than 0,500 mm (2 standard deviations about the human mean)
  * Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
  * Uncontrolled systemic or ocular disease
  * History of ocular trauma or prior ocular surgery
  * Fuchs Dystrophy
  * Subjects who may be expected to require retinal laser treatment or other surgical intervention, including LRI's
  * Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
  * Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
  * Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lens
SSVEP Evaluation of Brain Function (PRO)

The investigational device used in this clinical investigation, the Nurochek PRO System (NCPRO), is a portable electroencephalogram (EEG) headset which delivers a visual stimulus and measures a VEP. The visual stimulus is delivered to the subjects' eyes via light-emitting diodes, and the EEG measures the user's visual-evoked potential. This headset communicates with an application on a computer, which processes the signals and transmits them to a secure cloud server for analysis and storage of the data. Nurochek PRO is a development of the previously FDA cleared Nurochek System.

The primary objective of this clinical investigation was to evaluate the performance of the investigational device (NCPRO) against clinical diagnosis of detection of mild traumatic brain injury (mTBI). The primary endpoint outlined for this study was set at the collection of 100 valid investigational device readings from individuals with concussion and 500 valid investigational device readings from healthy individuals who have had a plausible mechanism of sustaining a concussion, but do not have one. Additionally, readings from healthy individuals are also to be acquired.

The aim of this study was to collect data from 100 readings from individuals with concussion. The initial assumption was that sites would provide players pre-season and make players available for testing post-concussion. In practice, some sites provided player data only post-concussion event (such as medical clinics). Participants were acquired from sporting clubs, medical clinicals and schools.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 12 years and older, participating in sport-related activities.

Exclusion Criteria:

* Individuals are excluded if they have a history of seizures, history of epilepsy, structural brain injuries, legal blindness, or sensitivity to flashing lights.
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid

The aim of the study "Fluorescence-guided resection of malignant gliomas with 5-Aminolevulinic acid (5-ALA) vs. conventional resection" is to determine how accurately contrast agent-accumulating tumour can be removed by primary surgery and to assess the clinical usefulness of this method.

Malignant gliomas are locally invasive tumors that carry a dismal prognosis despite a combination of surgery, radiotherapy and chemotherapy. Cytoreductive surgery is generally considered beneficial but complete resection of contrast enhancing tumor is achieved in less than 20 % of patients, one reason being the difficulty in discerning marginal, enhancing tumor intraoperatively.

Five-aminolevulinic acid (5-ALA) leads to the accumulation of fluorescent porphyrins in malignant gliomas, a phenomenon under exploration for intraoperative identification and resection of these tumors. This study investigated the benefit derived from fluorescent-guided resections using 5-ALA on surgical radicality, progression-free survival and morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Radiological suspicion of a unilocular malignant glioma with distinct ring- or garland-shaped contrast agent-accumulating tumour structures and a core of reduced intensity in the MRI (central necroses) with no significant non-staining tumour tissue (exclusion of a secondary malignant glioma).
* Indication for surgical tumour resection. If radical resection is planned, the location of the contrast agent-accumulating tumour should allow complete resection.
* First operation of the tumour, no other tumour-specific pretreatment
* Karnofsky at least 70 %
* Patient's written informed consent
* Age 18-72 years

Exclusion Criteria:

* Tumour location in the midline, basal ganglia, cerebellum or brain stem
* More than one contrast agent-accumulating lesion unrelated to the primary tumour or extracerebral metastases
* Porphyria, hypersensitivity to porphyrins
* Renal insufficiency: Creatinine \> 2.0 mg/dl
* Hepatic insufficiency: Bilirubin \> 3 mg/dl
* Quick test \< 60 %
* gamma-GT \> 70 U/I
* Malignancies other than basaliomas
* Existing or planned pregnancy or lactation, or inadequate contraception
* Simultaneous participation in another clinical trial or participation in another clinical trial in the 30 days preceding randomisation
Dose-escalation Study of IMC-001 in Subject With Metastatic or Locally-advanced Solid Tumors

This is a phase 1, Open-label, Multiple-ascending Dose Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of IMC-001 in Subjects with Metastatic or Locally-advanced Solid Tumors

IMC-001 is a PD-L1 targeting, fully human monoclonal antibody. The purpose of this study is to determine safety and evaluate PK, PD and clinical activity of IMC-001. Multiple dose levels of IMC-001 will be tested in subjects with metastatic or locally-advanced solid tumors. Data from this study will also help determine the recommended phase 2 dose of IMC-001.

Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form (ICF).
2. Adult (19 years or older).
3. Histologically or cytologically proven metastatic or locally-advanced solid tumors

Exclusion Criteria:

1. Treatment with non-permitted drugs (within the past 28 days of Screening), including but not limited to systemic immunosuppressive agents, any other investigational medicinal product (IMP), anti-coagulant, or live vaccines.
2. Any prior cancer immunotherapy
3. Concurrent anticancer treatments
The Effects of Peri-operative Pregabalin Administration on Post-operative Analgesia in Patients Undergoing Coronary Bypass Grafting

We hypothesize that the perioperative administration of pregabalin will significantly decrease pain scores and post-operative opioid requirements for patients undergoing coronary artery bypass grafting, and reduces the incidence of opioid-induced side effects such as respiratory depression. This may reduce ICU admission and possibly abbreviate length of hospital stay.


Eligibility Criteria:
Inclusion Criteria

* Patients whom are able and willing to provide written informed consent.
* Male and female 18-70 years of age.
* Patients whom are undergoing isolated coronary artery bypass grafting through a midline sternotomy for the treatment of ischemic heart disease.

Exclusion criteria

* Patients undergoing cardiac surgery for valvular or pericardial surgery.
* Patients with a documented ejection fraction of less than 50%.
* Patients with known chronic renal insufficiency and a calculated creatinine clearance of \< 60mL/min.
* Patients with known sensitivity to the study drugs.
* Patients with documented pre-existing chronic pain.
* Patients with seizure disorders.
* Patients whom are taking pregabalin or gabapentin
* Patients on chronic neuroleptic medications for control of psychiatric disorders as to avoid possible drug interactions and to avoid modulation of any pain states by such medications.
* Patients whom are taking tricyclic antidepressants or serotonin and norepinephrine re-uptake inhibitors(SNRI) will be excluded because of the effect of these drugs on neuropathic pain.
* Patients greater than 70 years of age will also be excluded because of their increased risk of side-effects and perioperative confusion.
* Pregnant or breast feeding females