cyrilzakka/clinical-trials huggingface dataset:
Adalimumab in Axial Spondyloarthritis (ASIM) - MRI and Biomarkers in Patients With Spondyloarthritis

Investigation of wholebody MRI and circulating biomarkers of inflammation, cartilage and bone metabolism in patients with spondyloarthritis treated with adalimumab. Furthermore to compare ultrasound examination with wholebody MRI etc.


Eligibility Criteria:
Inclusion Criteria:

* Spondyloarthritis (SpA) according to the new ASAS criteria for axial SpA
* BASDAI \> 40 mm despite NSAIDs
* Clinical indication for treatment with TNF-alpha inhibitor
* Age \> 18 years old and \< 85 years old
* Sufficient contraception for women
* Capable of giving informed consent
* Capable of complying with the examination program of the protocol

Exclusion Criteria:

* Pregnancy wish, pregnancy or breast-feeding
* DMARDs within 4 weeks prior to inclusion
* Oral, intra-articular or intramuscular glucocorticoid within 4 weeks prior to inclusion
* The use of other study drugs within 4 weeks prior to inclusion or less than 5 half-lives of the study drug before inclusion if this is more than 4 weeks
* The use of suspected disease-modifying or immunosuppressive drugs within 4 weeks prior to inclusion
* DMARDs are allowed during the study, but the dose cannot be changed from 4 weeks prior to inclusion through week
* Contraindications for TNF-α inhibitor treatment
* Contraindications for MRI
* Known recent drug or alcohol abuse
* Failure to provide written consent
* Incapable of complying with the examination program for physical or mental reasons
Post-Market Clinical Survey of Clareon® IOL AutonoMe™ in Japanese Subjects

This purpose of this survey study is to collect and describe clinical outcomes for the intraocular lens (IOL) delivery performance of Clareon® IOL AutonoMe™ when used in daily practice.

This study will enroll subjects who underwent prior cataract surgery with phacoemulsification and were implanted with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™ automated preloaded delivery system. Subjects will be enrolled post-operatively and followed for one year.

Eligibility Criteria:
Inclusion Criteria:

* Able to comprehend and willing to sign informed consent.
* Prior diagnosis of age-related cataracts.
* Prior cataract surgery with implantation of Clareon IOL in the capsular bag by AutonoMe™.
* No ophthalmic disease which might affect visual acuity.

Exclusion Criteria:

* None.
Quantification of Myocardial Blood Flow Using Dynamic PET/CTA Fused Imagery

This observational prospective clinical study is to develop software tools to fuse coronary anatomy data obtained from CT coronary angiography with dynamic PET data to noninvasively measure absolute myocardial blood flow, flow reserve and relative flow reserve across specific coronary lesions. Results will be compared to those obtained invasively in the catheterization laboratory.

This observational prospective clinical study is to develop software tools to fuse coronary anatomy data obtained from CT coronary angiography with dynamic PET data to noninvasively measure absolute myocardial blood flow, flow reserve and relative flow reserve across specific coronary lesions. These results will be compared to those obtained invasively in the catheterization laboratory. The long-term objective of the study is to improve the care of cardiac patients by developing, validating and implementing clinically computer-based methods to noninvasively determine the physiological significance of specific coronary lesions using methods to fuse and quantify multi-modality cardiac imagery.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years of age) - as the research topic to be studied is irrelevant to children
* Written consent form
* Patients with prior dynamic PET or CCTA or ICA for any indications

Exclusion Criteria:

* Previous history of allergy to iodinated contrast
* Previous CABG
* Serum creatinine levels \>1.8 mg/dl unless patient has end stage kidney disease, not producing any urine and dialysis
* History of claustrophobia (CT tunnel length of more than 100 cm)
* Significant arrhythmias or tachycardia
* History of frequent asthma attacks or acting wheezing
* Second- and third-degree heart block
* Systolic blood pressure of \< 90 mmHg
* Heart failure with NYHA class III-IV at the time of the CCTA procedure. If it is deemed that, the heart failure has been resolved or the patient was incorrectly labeled as having heart failure the radiology physician in charge will verify the absence of Heart Failure at the time of CCTA and perform the procedure.
* Recent myocardial infarction
* If the patient has been diagnosed with unstable angina within 24 hours prior to CCTA, the patient will not be consented. If the patient does not have the diagnosis of unstable angina and is consented, the radiology physician in charge will verify the absence of unstable angina at the time of CCTA.
* Patients enrolled and consented for the invasive measurements that at the time of catheterization exhibit severe vessel disease and/or obstructions that prevent the operator from safely conducting the measurements will be removed from the study; further research imaging sessions - if planned - will be canceled and patients indicated as "screen failure" in our enrollment log.
Neoadjuvant Camrelizumab, Nab-paclitaxel and Carboplatin in Stage IB-IIIA NSCLC

This prospective, single-arm, multicenter, phase II trial enrolled 40 patients who underwent surgery after three cycles of neoadjuvant therapy with camrelizumab, nab-paclitaxel, and carboplatin. The MPR is the primary endpoint, and the pCR, the complete resection rate, the objective response rate, the disease-free survival, adverse events, and quality of life are the secondary endpoints. The exploratory endpoints will be used to establish a multiomics artificial intelligence system for neoadjuvant therapy effect prediction and decision-making assistance based on radiomics, metabolism, genetic, and clinic-pathological characteristics and to explore drug resistance mechanisms.


Eligibility Criteria:
Inclusion criteria:

* The patients have stage IB-IIIA NSCLC.
* Patient ages are ≥ 18 years old, regardless of gender.
* The patients have an ECOG ps of 0-1, with a condition suitable for surgery.
* The patients have not received any anti-tumor treatment.
* The patients have adequate blood function.
* The patients have adequate organ function.
* The patients had been using an appropriate method of contraception, and there exists a negative pregnancy test (serum or urine) for women.
* The patients will give their signed informed consent.

Exclusion criteria:

* Patients who had a prior allogeneic tissue or organ transplantation.
* Patients who have multiple cancers.
* Patients who have any severe or uncontrolled systemic diseases.
* Patients with a positive test for HIV, HBV, or HCV.
* Patients with severe infection or with an infection that required antibiotic therapy.
* Patients with a history of interstitial lung disease, active tuberculosis, or autoimmune disease.
* Patients who have participated in any other clinical trials.
* Patients who are considered ineligible by the investigator.
Fixation Methods of Basicervical Fractures

This prospective, randomized study included patients aged over 65 years with basicervical fracture of femur from January 2016 to January 2018. The permuted block randomization method was used to randomize participants into groups. The patients were allocated to one of two groups treated via cephalomedullary nail (CMN) or sliding hip screw (SHS). Functional and radiological evaluations was included the mobility score, Harris hip score, modified Barthel index, the Singh index, the tip-apex distance, and fracture settling.

Approval for this prospective randomized study was granted by the Local Ethics Review Board and all procedures were performed in accordance with the ethical standards of the Declaration of Helsinki (1964). Patients with a basicervical femur fracture were identified on admission to the Emergency Department of our tertiary hospital from January 2016 to January 2018. Patients with scheduled surgery who met the inclusion criteria and provided written informed consent were included in the study.

Patients were randomly allocated to a study group by permuted blocks of randomly mixed sizes and stratification according to the type of surgery (CMN or SHS). Randomization was applied using pre-prepared randomization cards, which were placed in opaque sealed envelopes and given to the surgeons to open just prior to surgery, and the designated procedure was then performed.

Eligibility Criteria:
Inclusion Criteria:

* basicervical fracture,
* age of ≥65 year,
* an isolated fracture,
* the ability to walk independently (with or without an aid) prior to fracture,
* a fracture that had occurred less than one week prior to admission.

Exclusion Criteria:

* history of ipsilateral femoral fracture,
* a fracture due to malignancy,
* limited life expectancy due to medical comorbidities,
* any contraindication to surgery,
* diagnosed dementia,
* any other traumatic fracture on admission.
Screening Effect of Dual-energy CT Combined With Nasopharyngeal Endoscopy for Screening Nasopharyngeal Carcinoma

All participants will be tested for EBV-related biomarkers, including EBNA1-IgA, VCA-IgA, and BNLF2b total antibody (P85-Ab), and participants with high serologic risk will be selected based on serologic test results, and dual-energy CT will be performed first for high-risk screening subjects, and dual-energy CT will be performed first for the high-risk group to record dual-energy CT examinations of those suspected of nasopharyngeal carcinoma, and then endoscopy was performed on the high-risk group to record those suspected of nasopharyngeal carcinoma under endoscopy, and finally biopsies were taken for positive lesion sites indicated by dual-energy CT and suspicious lesion sites found by endoscopy to clarify the diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Subject residents in Zhongshan City
* Subject has no medical record of nasopharyngeal carcinoma
* Subject is able to comprehend, sign, and date the written informed consent document to participate in the study
* Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study

Exclusion Criteria:

* Subject has heavy cardiovascular, liver or kidney disease
* Subject has contraindications to nasopharyngeal endoscopy
* Subject has contrast media allergy
A National Observation Study on Pelvic Floor Dysfunction Diseases in China

In this protocol, our team intend to conduct a nation-wide multicenter cohort research to screening for PFD symptoms in early postnatal women in China. Beside clinically significant symptoms, we will also measure the recovery trend of pelvic muscle function, aiming to determine the clinically significant alterations that are sensitive to predict the PFD risks. This is an observational prospective cohort study, following a natural regular clinical visit process. Patients will voluntarily decide whether to receive PFD related treatments and the types of treatments to adopt. Therefore, we will also be able to compare the effectiveness of treatments.


Eligibility Criteria:
Inclusion Criteria:

1. Postpartum women: 42 days+15 days after delivery
2. Age:20-45
3. Consent to participate in the research.

Exclusion Criteria:

1. Refuse gynecological and/or obstetrical examinations.
2. Diagnosed with psychiatric disorders
3. Diagnosed with other severe illnesses
4. Received pelvic floor treatments
5. Other factors that may confound with the research
DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension

This is a randomized, double-blind, placebo- and active-controlled study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States Food and Drug Administration (FDA), which means that a doctor cannot prescribe this drug. The purpose of this study is to determine if darusentan is effective in reducing systolic and diastolic hypertension despite treatment with full doses of three or more antihypertensive drugs, including a diuretic. Subjects will be randomized to darusentan (optimized dose), an active comparator, or placebo, administered orally. The treatment period for this trial is 14 weeks.


Eligibility Criteria:
SELECTED INCLUSION CRITERIA:

1. Subjects who are competent to provide written consent;
2. Aged 35 to 80 years;
3. Subjects with diabetes and/or chronic kidney disease must have an average sitting systolic blood pressure greater than or equal to 130 mmHg;
4. All other subjects must have an average sitting systolic blood pressure greater than or equal to 140 mmHg;
5. Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic;
6. Female subjects of non-childbearing potential (i.e., post-menopausal for at least 2 years or surgically sterile).

SELECTED EXCLUSION CRITERIA:

1. Average sitting systolic and diastolic blood pressure greater than or equal to 180 mmHg and 110 mmHg, respectively;
2. Subjects treated with a central alpha-2 agonist and/or imidazoline receptor agonist;
3. Left ventricular dysfunction;
4. Serum ALT or AST greater than 2 times the Upper Limit of Normal;
5. Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachycardia, recurrent ventricular tachycardia, or symptomatic bradycardia;
6. Implanted pacemakers or cardioverter defibrillator;
7. Symptomatic congestive heart failure requiring treatment;
8. Hemodynamically significant valvular heart disease;
9. Hemodialysis or peritoneal dialysis, or history of renal transplant;
10. Type I diabetes mellitus;
11. Diagnosis or recurrence of malignancy within the past 3 years;
12. Sleep apnea, unless a recent sleep study demonstrated arterial oxygenation saturation greater than or equal to 90%, treated or untreated;
13. Subjects who perform alternating shift or night work;
14. Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening
Digital Therapeutic for Chronic Pain Feasibility Study

The investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger efficacy trial based on our primary outcomes. The intervention arm will test a mobile app that aims to help people reduce pain interference who have chronic pain, as well as mental health issues with depression and anxiety. Participants in the intervention arm will also have the option to sense health data with a tracker that integrates with the app, which will inform the feasibility of this feature.

This study will evaluate the existing 2Morrow Chronic Pain Self-Management Program, in the form of a mobile app, as a digital therapeutic for improving patients' pain self management and function who suffer from chronic pain. Specifically, the investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger efficacy trial based on our primary outcomes. The intervention arm will test a mobile app that aims to help people reduce pain interference who have chronic pain, as well as mental health issues with depression and anxiety. Participants in the intervention arm will also have the option to sense health data with a tracker that integrates with the app, which will inform the feasibility of this feature.

Eligibility Criteria:
Inclusion Criteria:

* \>=18 years old
* at least one ICD pain related diagnosis noted in the electronic health record (EHR)
* at least 2 visits in a primary care clinic with at least one in the last 12 months
* willing to use a mobile app in English
* T-score for the PROMIS brief pain inventory of \>= 55
* access to a smartphone
* willing to download and use a mobile app daily

Exclusion Criteria:

* current cancer related diagnosis (to exclude cancer related chronic pain)
* plans for surgery in next 3 months
* pregnant
* currently receiving hospice care
Optimizing Drug-Therapy in Patients 80 Years and Older

The purpose of this study is to measure the effects of an enhanced service where a pharmacists is part of the healthcare team on the ward (focusing on drug-related problems and transferring information between primary and secondary care). Primary outcome measure is visits to hospital during a 12-month follow-up period, and the population is patients 80 years and older.

Optimising drug-therapy for patients, 80 years and older, to reduce hospital visits

Background and Objective:

Results from a pilot-study performed in 2004 at the Academic Hospital, Uppsala, including 214 consecutive patients (80 years old or older) showed that 9.4%-13.6% of the patients were acutely admitted to hospital due to a drug related problem1. Other similar international studies show that the frequency of drug-related hospital admissions stands for at least 14% of the acute admissions (14%-30.4%). Of these admissions it was estimated that 32%-69% were preventable 2,3,4.

A study from Antrim Hospital, Northern Ireland, showed that pharmacists´ involvement in the health care team can reduce the number of acute hospital admissions and improve quality of drug use5.

In view of these findings this study was initiated in 2005 with fundings from the Drug and Therapeutics committee, the County Council of Uppsala, the Division of Acute-Medicine and the Pharmacy Department at the Academic Hospital in Uppsala

Aim and objectives:

The Study Aim was to optimize drug-prescribing and drug use for patients 80 years and older.

The main objective was to reduce the number of hospital visits for patients 80-years old or older.

Design:

A randomized, controlled trial including 400 patients (200+200). Patients in the intervention group (I) received a patient interview on admission, drug counseling on discharge and a drug review - all performed by a clinical pharmacist. Patients in the control group (C) received standard care, without pharmacists´ involvement.

Patients were included between Oct 2005 and June 2006.

Setting:

Two wards at the Division of Acute-Medicine at Uppsala University Hospital, Sweden

Main Outcome Measures:

1) Frequency of hospital visits 12 months after (last included patient) discharge from hospital for (I) and (C).

Eligibility Criteria:
Inclusion Criteria:

* 80 years and older
* Acute admission to study ward

Exclusion Criteria:

* \<80 years
* Scheduled admission
* Previously admitted to studyward during study period
Application of Early Goal-directed Sedation in Patients With Severe Brain Injury

EGDS management strategy was implemented in ICU patients with severe brain injury, the depth of sedation and GCS score were monitored, and the protective effects of EGDS strategy and standard sedation strategy on the brain of patients with severe brain injury were discussed.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of severe craniocerebral injury
* The GCS score is 6 to 12 points
* Within 12 hours of intubation
* The mechanical ventilation time is greater than 24 hours
* Obtain written consent

Exclusion Criteria:

* Pregnant women
* Acute liver failure
* Dementia or mental illness
A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer

To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT.
* Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
* Planned to receive standard cisplatin chemotherapy administered either weekly or every third week.
* Must be able to read and understand informed consent
* Adequate birth control methods for the duration of the study

Exclusion Criteria:

* Current mucositis.
* Prior radiation to the head and neck.
* Chemotherapy treatment within the previous 12 months.
* Tumors of the lips, sinuses, salivary glands or nasopharynx.
* Unknown primary tumor.
* Stage 4c metastases.
* Evidence of significant hepatic, hematologic, or immunologic disease.
* Women who are pregnant or breast-feeding.
Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux

Investigation evaluating the effect of coffee on gastro-esophageal reflux disease.

Many patients with gastro-esophageal reflux disease (GERD) report that drinking coffee causes heartburn. The purpose of this study is to investigate the effects of coffee on gastro-esophageal acid reflux, and its relation to esophageal motility parameters in patients who are already scheduled to undergo 48 hour wireless pH testing as a result of having symptoms suggestive of GERD. The specific aims are to evaluate the effects of coffee on GERD during daily life and to elucidate the underlying pathogenic mechanism by which coffee induces reflux.

Eligibility Criteria:
Inclusion Criteria:

* persons undergoing wireless pH testing for diagnosis and treatment of GERD

Exclusion Criteria:

* those under the age of 18
* pregnant and lactating women
* those who do not meet the inclusion criteria
Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses

The goal of this study is to compare the performance of two daily disposable silicone hydrogel contact lenses.

This study is a prospective, bilateral eye, double masked, randomized, 1-week crossover, daily wear design involving two different daily disposable lens types. Each lens type will be worn for approximately one week.

Eligibility Criteria:
Inclusion Criteria:

1. Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Self-reports having a full eye examination in the previous two years;
4. Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
5. Is willing and able to follow instructions and maintain the appointment schedule;
6. Habitually wears soft contact lenses, for the past 3 months minimum;

   1. No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys
   2. No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day.
7. Has refractive astigmatism no higher than -0.75DC in each eye;
8. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active ocular disease and/or infection that contraindicates contact lens wear;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Has undergone refractive error surgery or intraocular surgery.