cyrilzakka/clinical-trials huggingface dataset:
Low-dose Aspirin Therapy in Patients With Ischemic Stroke and Microbleeds

The purpose of this study is to investigate the safety and efficacy of low-dose (50mg) aspirin as a secondary prevention drug in patients with Non-Cardioembolic Ischemic Stroke accompanied by cerebral microbleeds.

Cerebral microbleeds are caused by microvascular lesions in the brain, which is a subclinical deposition of hemosiderin after the damage of microvascular. Aspirin is the most widely used anti-thrombotic drug in the secondary prevention of patients with non-cardioembolic ischemic stroke. Studies have shown that conventional doses of aspirin can increase the incidence of intracranial hemorrhage in ischemic stroke patients with cerebral microbleeds. For such patients, how to carry out effective and safe anti-thrombotic therapy is still unclear.

The AIM study aims to provide reliable data on the effects of low-dose Aspirin (50mg target recruitment 200) in patients with non-cardioembolic ischemic stroke and cerebral microbleeds compared to conventional dose (100mg target recruitment 200). Patients presenting with acute (\<3 weeks) non-cardioembolic ischemic stroke and microbleeds (≧1 microbleeds in SWI scans) will be randomly assigned to the secondary stroke prevention therapy of low-dose or conventional dose aspirin for 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with cerebral infarction diagnosed clinically as non-cardioembolic ischemic stroke;
2. Age ≥ 18 years;
3. Onset time ≤ 3 weeks;
4. At least one cerebral microbleeds lesion was found on SWI;
5. Informed consent was signed.

Exclusion Criteria:

1. Patients with symptomatic intracranial hemorrhage;
2. No microbleeds or bleeding lesion \> 10 mm was found on SWI;
3. Vascular malformations, tumors, abscesses or other major non ischemic brain diseases were present;
4. Clear anticoagulant indications (such as atrial fibrillation);
5. There are contraindications for aspirin use;
6. The focus of microbleeds is limited to the cortex or other evidence suggests that the patient has cerebral amyloid angiopathy;
7. Patients with coronary heart disease or other diseases need to take antiplatelet drugs;
8. Serious systemic diseases;
9. Refusal to sign informed consent or poor compliance.
Thoracic Manipulation and Mobilization for Neck Pain

The purpose of this randomized clinical trial was to examine the widespread effects of thoracic spine thrust manipulation and thoracic non-thrust mobilization on pressure pain sensitivity and neck pain intensity in patients with chronic mechanical neck pain.


Eligibility Criteria:
Inclusion Criteria:

* mechanical idiopathic neck pain
* bilateral pain symptoms
* chronic pain (\>3 months of duration)

Exclusion Criteria:

* whiplash injury
* previous spine surgery
* diagnosis of cervical radiculopathy or myelopathy
* diagnosis of fibromyalgia
* having undergone any physical therapy intervention in the previous year
* pregnancy
PASCUAL (Prostate Assay Specific Clinical Utility at Launch) Study

The main hypothesis of this study is to demonstrate that the use of the ConfirmMDx for Prostate Cancer test in previously biopsied patients improves urologists' patient management by reducing unnecessary repeat biopsies, attendant procedure costs, and potential adverse events in men being considered for a repeat procedure.

The results of the study will reveal the clinical utility of this test by analyzing the physicians' use of negative or positive assays compared to patients managed using SOC methods without assay findings. The repeat biopsy rate at 12 months from study entry will be used for the primary endpoint analysis. All patients will be followed for 24 months from the date of the previous negative biopsy to evaluate an extended period of observation to track repeat biopsies and cancer detection.

The primary objective of this study is to demonstrate a lower repeat biopsy rate by using the negative results of ConfirmMDx for Prostate Cancer in practice rather than current SOC. All patients will have the tissue from their previous negative biopsy tested with the assay. Only data from Cases (informed of ConfirmMDx assay results) and Controls (blinded of the ConfirmMDx assay result) patients with negative test results will be used for the primary objective.

Eligibility Criteria:
Inclusion Criteria:

* Males aged 40 to 75 years old\* that underwent a previous cancer-negative prostate biopsy within 15 months and being considered for a repeat biopsy due to persistent or elevated cancer-risk factors
* The previous negative prostate biopsy must have collected a minimum of 8 tissue cores and remaining FFPE tissue from all cores should be available for testing
* Minimum tissue volume criteria of 20 microns of prostate biopsy core tissue should be available (40 microns preferable)
* The presence of HGPIN (high-grade prostatic intraepithelial neoplasia), PIA (proliferative inflammatory atrophy), or glandular inflammation reported in the first biopsy histopathology report is acceptable for entry.

Exclusion Criteria:

* Prior diagnosis of prostate cancer or cellular atypia suspicious for cancer (ASAP) in a previous biopsy histology report.
* Patients being managed by Active Surveillance for low stage prostate cancer
* Men greater than 75 years old (generally not considered for repeat biopsy)
* Most recent biopsy was a saturation biopsy (\> 24 tissue cores).
* Tissue extracted using transurethral resection of the prostate (TURP) procedures rather than standard patterned biopsy core extraction.
* Subjects who had been previously tested with ConfirmMDx.
Sintilimab (IBI308) in the Neoadjuvant Treatment of Patients With Resectable II-IIIA NSCLC

The aim of this study was to investigate the safety and efficacy of Sintilimab (IBI308) in patients with resectable NSCLC, and to provide new treatment options for neoadjuvant therapy in patients with stage II-IIIA NSCLC

Sintilimab injection (IBI308) as neoadjuvant therapy in patients with resectable NSCLC

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 years old to 75 years old, male or female;
2. Histologically or cytologically confirmed NSCLC (stage II-IIIA, American Joint Committee on Cancer, eighth edition) that was surgically resectable;
3. Being treatment-naive and the diameter of primary tumor was greater than or equal to 1 cm;
4. ECOG performance status score: 0-1;
5. The function of important organs meets the following requirements (no blood components and cell growth factors are allowed for 2 weeks before the start of study): Absolute neutrophil count (ANC)≥1.5×10 E+9/L; platelets≥100×10E+9/L / L; hemoglobin ≥9g/dL; serum albumin(ALB)≥2.8g/dL; a total bilirubin (TBil) of≤1.5 ULN, ALT and AST≤2.5 ULN, in case of liver metastasis, ALT and AST≤5 ULN; creatinine clearance rate≥ 50mL/min(Cockcroft-Gault);thyroid function is normal.
6. Estimated survival time≥3 months;
7. PD-L1 expression level ≥ 1%；
8. Patients were voluntarily enrolled in the study and signed an informed consent form (ICF) with good adherence and follow-up.

Exclusion Criteria:

1. The patient has any active autoimmune disease or a history of autoimmune disease;
2. The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose\>10 mg / day of prednisone or other therapeutic hormones);
3. History of interstitial lung disease;
4. Severe allergic reactions to other monoclonal antibodies;
5. Previous allogeneic organ transplantation or hemopoietic stem cell transplantation;
6. Have clinical symptoms or disease that are not well controlled ;
7. Grade III to grade IV congestive heart failure;
8. Uncontrolled hypertension;
9. Artery thrombosis, embolism, or ischemia within 6 months before study treatment;
10. Coagulation disorders;
11. Active and uncontrolled infection;
12. The patient has previously received other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1;
13. Any other known malignant tumor;
Stress Echocardiography and Heart Computed Tomography (CT) Scan in Emergency Department Patients With Chest Pain

The purpose of this study is to determine whether stress echocardiography or computed tomography (CT) of the heart is better at diagnosing emergency room chest pain patients to select appropriate candidates for hospitalization and further work-up.


Eligibility Criteria:
Inclusion Criteria:

* Presentation to the Emergency Department with chest pain
* Low-to-intermediate risk of coronary disease per Diamond-Forrester criteria
* Free of known coronary artery disease

Exclusion Criteria:

* Inability to undergo both stress echo or coronary CT for any reason
* Contraindication to intravenous iodinated contrast
* Dysrhythmia precluding EKG gating
* Heart rate greater than 60 with contraindication to beta blockers
* Administration of beta blockers within the last 12 hours
* Known severe cardiac valvular disease or pulmonary hypertension
* Stress echocardiography, coronary CT or catheterization within the last 6 months
Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke

Rationale: Over 20.000 people suffer an ischemic stroke in the Netherlands each year. Large artery occlusions are easy to identify and can be treated with endovascular clot removal. 70% of patient will however suffer from a more distal occlusion resulting in small volume stroke or a transient ischemic attack (TIA). Small ischemic lesions are hard to detect with current acute stroke protocols. TIA and small volume stroke patients, are at an increased risk for recurrent stroke, making immediate diagnosis critical. Because thrombo-embolic sources often cause these strokes, identifying and treating the underlying aetiology has the potential to radically lower the risk of recurrence and improve the outcome of these patients.

Objectives: 1) To identify clinical and imaging predictors of recurrent stroke; 2) To improve early detection of small volume stroke with admission computed tomography perfusion (CTP) in patients with suspected acute ischemic stroke with small volume stroke or no ischemia on admission imaging.

Study design: Prospective, multicenter cohort study.

Study population: All patients who visited the University Medical Center (UMC) Utrecht, the Amsterdam University Medical Centers (Amsterdam UMC), location Academic Medical Center (AMC) or the St. Antonius Hospital and who underwent a CT-scan of the brain within 9 hours after onset of stroke symptoms with an age ≥18 years. Within 36 months, 720 patients will be enrolled in the study. Of these patients, 300 patients will be included for the follow-up magnetic resonance imaging (MRI).

Main study parameters/endpoints: The main study endpoints are: 1) Stroke recurrence rate at 2 years; 2) Presence and volume of acute ischemic lesions on follow-up diffusion weighted imaging MRI.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Time from symptom onset until imaging is \<9 hours\*;
* Clinical diagnosis of acute ischemic stroke or TIA;
* Informed consent from patient or family after the admission scan (unless the patient died).

  * Patients who awaken with stroke symptoms can only be included if they went to sleep without any stroke symptoms and the time from going to sleep until imaging is less than 9 hours.

Exclusion Criteria:

* Patients with another diagnosis such as intracerebral hemorrhage, subarachnoid hemorrhage or tumor;
* Patients with known contrast allergy or renal failure.
Patient Based Strategy to Reduce Errors in Diabetes Care

This project evaluates a HPMG effort to reduce error rates through customized direct feedback of diabetes quality of care data to diabetes patients and their physicians. HPMG has routinely provided patients with personalized feedback of glucose and cholesterol test results since about 1997. This project will implement and evaluate the impact of this intervention on diabetes medical error rates and resource use.

The project, Patient-Based Strategy to Reduce Errors in Diabetes Care (referred to as MOVES), addresses issues of overuse, under use, or misuse of care for adults with diabetes. This combination research and translation project has been developed as a component of the Pursuing Perfection initiative of HealthPartners Medical Group, with the close collaboration of HPMG leadership. HealthPartners Medical Group is widely regarded as a national leader in diabetes care, with dramatic improvements in both glucose control and cholesterol control over the past 8 years \[Graphs\].

The MOVES study is attempting to activate patients with diabetes to be more involved in their care. To help patients do this, HPMG sends patients a customized summary of their care. The summary includes a graph of recent glucose and cholesterol test results and specific suggestions that may improve care. In many cases, a visit with the patient's personal physician is encouraged to assure ongoing progress towards important evidence-based goals in diabetes care.

Physicians also receive a matched communication that indicates areas for potential improvement and makes technical suggestions for care based on the Staged Diabetes Management © protocols. The project tries to ally expert judgment with the physician's personal knowledge of a patient. It is felt that this approach is critical to assessing what the best improvement strategy may be in each individual case.

This inexpensive customized intervention has potential to be widely disseminated and can be seamlessly integrated with other interventions to further achievement of clinical goals. The results are relevant to patients, clinicians, payers, and policymakers.

Eligibility Criteria:
Inclusion Criteria:

* For physician intervention inclusion criteria included; 1)primary care (general internist or family) physician in HealthPartners Medical Group. 2)Provided ongoing care to 20 or more adult patients with diabetes.
* For patients inclusion criteria included; An established diagnosis of diabetes based on either (a) two or more ICD-9 diagnosis codes for diabetes in a 12-month period of time, or (b) a filled prescription for a diabetes-specific drug within a 12-month period of time.

In addition, participating patients met all of the following criteria: (a) age less than 75 years, (b) Charlson comorbidity score of 3 or less, (c) linked to the a primary care physician who was participating in the study in two consecutive calendar years, (d) had pharmacy coverage at the time of the intervention and for the previous 12-month period, and (e) had either HBA1c \> 7% or LDL \> 130 mg/dl (or LDL \> 100 mg/dl if the patient also had CHD).

Exclusion Criteria:

* none
Gut Microbiome Modification Through Dietary Intervention in Patients With Colorectal Cancer: Response to Surgery

The investigators will conduct an open, controlled, randomized clinical trial, in patients with scheduled surgical intervention for CRC in the General Surgery and Digestive System Unit of the Virgen de la Arrixaca University Hospital (Murcia, Spain). All the included individuals must have passed the protocol of the Virgen de la Arrixaca University Hospital to be candidates for elective major surgery for CRC and must sign the informed consent after being informed of the objectives and the methodology of the study. The Helsinki Declaration will be followed during the duration of the project.

Patients will be randomized in a 1:1 ratio after receiving a diagnosis of CRC in the endoscopic evaluation; in the control arm, patients will receive standard nutritional recommendations, while patients in the intervention arm will be advised to follow a high-fiber diet rich in PUFAs (total dietary intake of at least 30 grams of fiber per day, and of at least 3 grams of PUFAs per day from food, not supplements) at least 4 weeks before surgery


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-80 years old.
* After clinical diagnosis of CRC (stage I-III), the doctor has recommended and arranged for CRC surgery

Exclusion Criteria:

* Clinical diagnosis of stage IV CRC.
* Current gastrointestinal illness other than gastroesophageal reflux disease or hemorrhoids (such as celiac disease, inflammatory bowel disease, malabsorptive bariatric procedures, etc.).
* Chronic liver or kidney disease.
* History of cardiac disease.
* Positive genetic test for inherited polyposis syndromes (such as familial adenomatous polyps, hereditary non-polyposis colon cancer syndromes, etc).
* Alcoholism or illicit drug use.
* Antibiotic use within the past 2 months.
* Dietary supplement use including pre- or probiotics within the past month.
* History of intestinal cancer, inflammatory bowel disease, celiac disease, or malabsorptive bariatric surgery.
* Inflammatory or connective tissue disease (such as lupus, scleroderma, rheumatoid arthritis, etc.).
Compare Rates of Agreement Between Clinical Diagnosis and Visual Assessment of DaTscan™ Images in Non-Caucasian and Caucasian Subjects With Parkinson's Disease (PD) or Essential Tremor (ET)

The primary objective of this study is to determine if the diagnostic performance of DaTscan™ single photon emission computed tomography (SPECT) imaging is different in non-Caucasian subjects compared with Caucasian subjects with movement disorders.


Eligibility Criteria:
Inclusion Criteria:

For Non-Caucasians:

* Non-Caucasian male and female adult participants (greater than or equal to 18 years of age) with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
* The participant had existing diagnostic-quality and interpretable DaTscan SPECT images of the brain.

For Caucasians:

* Caucasian male and female adult participants (greater than or equal to 18 years of age) with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
* The participant had existing diagnostic-quality and interpretable DaTscan SPECT images of the brain.
* The participant was matched by final clinical diagnosis, sex and age (±5 years) with a non-Caucasian participant.

Exclusion Criteria:

* Known/suspected structural abnormalities of the brain (e.g., hydrocephalus; brain tumor; stroke; etc.) that could grossly distort the DaTscan images.
* Participants whose race and ethnic information could not be determined from source document review.
Patient-Reported Outcome Of Facial Erythema (PROOF)

The purpose of the study is to evaluate the patient-reported outcomes (feedbacks of patients)of a new drug for the treatment of erythema of rosacea (central facial redness). The feedback of patients receiving the active drug will be compared to the feedback of patients receiving the placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects age of 18 years or older
* A clinical diagnosis of facial rosacea
* A Patient Self-Assessment score of 4 (severe) at Baseline prior to the study drug application
* A Clinician's Erythema Assessment (CEA) score of 3 (moderate) or 4 (severe) at Baseline prior to the study drug application

Exclusion Criteria:

* More than 5 facial inflammatory lesions (papules or pustules) of rosacea
* Any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or put the subject at significant risk if the subject participates in the clinical trial as judged by the investigator
* Known or suspected allergies or sensitivities to any component of the study drugs, including the active ingredient brimonidine tartrate (see Investigator's Brochure)
* Female who is pregnant or lactating
FUNCTIONAL ASSESSMENT FOR SURGERY BY A TIMED WALK

The FAST Walk study aims to determine whether a walking test called the 6-minute walk test (6MWT) can help identify people who are more likely to experience complications after surgery. This test will be completed before surgery. We hope that the results of this study will help improve care for patients having major surgery in the future.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥40 years
2. ≥1 risk factors for postoperative complications
3. Elective non-cardiac surgery with expected post-surgery stay ≥2 days
4. Preoperative 6MWT is feasible
5. Working knowledge of official language(s) in country of study recruitment

Exclusion Criteria:

1. Endovascular surgery
2. Lower limb orthopedic surgery
3. Contraindications to 6MWT
A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause

The purpose of this study is to demonstrate the efficacy of rotigotine against placebo in adolescent subjects with idiopathic Restless Legs Syndrome (RLS) over a 12-week maintenance period and to investigate the safety and tolerability of rotigotine in adolescent subjects with idiopathic RLS.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female, and is \>=13 and \<18 years of age at Baseline
* Subject's Restless Legs Syndrome (RLS) symptoms cause significant daytime symptoms or significant distress or impairment in social, occupational, educational, or other important areas of functioning by the impact on sleep, energy/vitality, daily activities, behavior, cognition or mood
* At Baseline, subject has a score of \>=15 on the International Restless Legs Rating Scale (IRLS) (indicating moderate-to-severe RLS)
* At Baseline, subject scores \>=4 points on the Clinical Global Impressions (CGI) Item 1 assessment (indicating at least moderately ill)
* Subjects who are receiving supplemental iron have been on a stable dose for at least 1 month prior to Screening
* Female subjects must be surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is an acceptable method. Subjects must agree to use adequate contraception during the study and for 4 weeks after their final dose of study medication.

Exclusion Criteria:

* Subject has a serum ferritin level below the lower limit of normal at Visit 1/Screening
* Subject has a hemoglobin level below the lower limit of normal at Visit 1/Screening
* Subject has had previous treatment with dopamine agonists or L-dopa within 7 days prior to Visit 2/Baseline
* Subject has any medical or psychiatric condition, which in the opinion of the investigator, would jeopardize or compromise the subject's well-being or ability to participate in this study
* Subject is pregnant or nursing
* Subject is not willing to abstain from caffeine after 4 pm each evening within 7 days prior to Visit 2/Baseline and for the duration of the study
* At Visit 1/Screening, subject has symptomatic orthostatic hypotension with a decrease of blood pressure (BP) from supine to standing position of \>=20 mmHg in systolic blood pressure (SBP) or of \>=10 mmHg in diastolic
* Subject has secondary Restless Legs Syndrome (RLS) (eg, due to renal insufficiency \[uremia\], iron deficiency, or rheumatoid arthritis)
* Subject has a lifetime history of suicide attempts (including actual attempt, interrupted attempt, or aborted attempt), or had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1)
* Subject is taking a prohibited concomitant medication. Prohibited concomitant medication must have been discontinued at least 2 weeks prior to Screening (Visit 1)