cyrilzakka/clinical-trials huggingface dataset:
Intensive Drug Therapy for Ischemic Stroke

To observe the safety and efficacy of intensive drug therapy for ischemic stroke patients.Patients with acute stroke caused by intracranial arterial stenosis (stenosis rate ≥70%) were enrolled and accept dual antiplatelet therapy (DAPT) (aspirin 100 mg/d and clopidogrel 75 mg/d for 90 days, followed by aspirin 100 mg/d for long term) under the guidance of platelet function analysis (Verifynow) combined with the intensive statin therapy (40 mg/d for 14 days, followed by 20 mg/d for long term).

Patients (35 to 80 years ) with acute ischemic stroke, who can be treated within 72 hours of symptom onset will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomly selected.Patients were treated with dual antiplatelet therapy (DAPT) (aspirin 100 mg per day and clopidogrel 75 mg per day were administered for 90 days, followed by aspirin 100 mg per day for long term) and atorvastatin (40 mg per day for 14 days, followed by 20 mg per day long term) after enrollment. Patients with aspirin resistance (aspirin reaction units \[ARU\] ≥550) or clopidogrel resistance (P2Y12 reaction units \[PRU\] ≥208) were excluded on the 7th day of therapy.The primary objective is to observe the safety and efficacy of intensive drug therapy for ischemic stroke patients. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by the Ethics Committee of Huashan Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Age between 35 and 80 years;
* Onset \<72 hours;
* New-onset ischemic stroke confirmed by skull magnetic resonance diffusion weighted imaging (MR-DWI);
* Severe ICAS (stenosis ≥70%) indicated by time-of-flight magnetic resonance angiography (TOF-MRA).

Exclusion Criteria:

* Ischemic stroke caused by other etiological factors (e.g., cardio-embolism, arterial dissection, vasculitis, etc.);
* Post-infarction hemorrhagic transformation and intraplaque hemorrhage as indicated by imaging examination;
* Contraindications to aspirin, clopidogrel, or atorvastatin;
* Intracranial hemorrhage within 3 months and a recent history of surgery or trauma;
* Severe organ impairment, liver insufficiency, and renal insufficiency;
* Complicated with tumors or hemorrhagic diseases;
* Use of drugs forbidden to use in combination after onset, including other antiplatelet drugs, anticoagulants, thrombolytic drugs, and drugs affecting antiplatelet agents and statin metabolism.
Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®

This is a feasibility study to determine the usefulness of a brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit lung cancer patients by reducing the radiation dose to critical structures, such as the heart wall, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.


Eligibility Criteria:
Inclusion Criteria:

* Subject signed inform consent
* Suspected or proven non-small cell lung cancer (NSCLC) in the upper lobes of the left or right lung
* Pre-operative criteria
* Lung nodule suspicious for NSCLC
* Mass ≤ 7 cm in maximum diameter by CT scan of the chest and upper abdomen
* Clinical stage I or Clinical stage II
* Not pregnant or nursing
* Negative pregnancy test in premenopausal women
* Fertile patients must use effective contraception
* More than 5 years since prior invasive malignancy unless non melanoma skin cancer or in-situ cancer

Exclusion Criteria:

-
Efficacy of Risk Assessment for Sudden Cardiac Death in Patients With Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a heart disease characterized by hypertrophy of the left ventricular myocardium and is most often caused by mutations in sarcomere genes. The structural and functional abnormalities cannot be explained by flow-limiting coronary artery disease or loading conditions. The disease affects at least 0,2% of the population worldwide and is the most common cause of sudden cardiac death (SCD) in young people and competitive athletes due to fatal ventricular arrhythmia, but in most patients, however, HCM has a benign course. Therefore, it is of utmost importance to properly evaluate patients and identify those who would benefit from a cardioverter-defibrillator (ICD) implantation.

Hypertrophic cardiomyopathy (HCM) is a heart disease characterized by hypertrophy of the left ventricular myocardium and is most often caused by mutations in sarcomere genes. The structural and functional abnormalities cannot be explained by flow-limiting coronary artery disease or loading conditions. The disease affects at least 0,2% of the population worldwide and is the most common cause of sudden cardiac death (SCD) in young people and competitive athletes due to fatal ventricular arrhythmia, but in most patients, however, HCM has a benign course. Therefore, it is of utmost importance to properly evaluate patients and identify those who would benefit from a cardioverter-defibrillator (ICD) implantation.

This study assesses the accuracy of the HCM SCD-Risk Calculator, recommended by European Society of Cardiology guidelines, in patients treated in the Ist Department of Cardiology of Poznan University of Medical Sciences from 2005 to 2018.

The study group consisted of 252 patients aged 20-88 (mean 53,8 ± 15,1, median 54); 49,6% were men. The protocol consisted of medical history collection (including a questionnaire), physical examination and additional tests such as echocardiography with the assessment of global longitudinal strain and average strain, cardiac magnetic resonance, ambulatory ECG monitoring, control of implantable devices and exercise testing.

Eligibility Criteria:
Inclusion Criteria:

1. Hypertrophic cardiomyopathy,
2. Minimum 18 years,
3. Questionnaire,
4. Assessment of HCM SCD-Risk Calculator at the beginning of the observation,
5. Regular visits in Cardiology Outpatient Clinic,
6. Agreement to participate in the study

Exclusion Criteria:

1. Poorly controlled hypertension (systolic pressure on the next two visits in the Cardiology Outpatient Clinic \>180 mmHg),
2. Haemodynamically significant valvular heart disease or valve replacement condition,
3. Past myocardial infarction (haemodynamically significant changes found in coronarography),
4. Heart transplant,
5. Insufficient amount of data from the subject and additional tests allowing for further analysis,
6. Lack of consent to participate in the study.
COMPARISON OF CORNEAL MEASUREMENTS IN NORMAL AND KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER

The purpose of current study is to provide a comprehensive comparison of the reliability of corneal topographic measurements between Optovue AS- OCT and a combined Scheimpflug imaging using Wavelight Oculyzer Pentacam HR in normal and keratoconus eyes.


Eligibility Criteria:
Inclusion Criteria:

* topography characteristic of keratoconus (skewed asymmetric bow-tie, inferior steep spot, etc.) and at least one clinical sign e.g., slit lamp findings of Munson's sign, Vogt's striae, Fleischer's ring, apical thinning, Rizutti's sign, etc.

Exclusion Criteria:

* are advanced complications of keratoconus such as corneal scars or hydrops.
Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola. Virus Disease (EVD) in Sierra Leone. EASE (EMERGENCY Amiodarone Study Against Ebola)

The purpose of this study is to evaluate the efficacy and safety of amiodarone in the treatment of patients afflicted with Ebola virus disease.


Eligibility Criteria:
Inclusion Criteria:

* patient admitted to the Emergency ETC at Goderich with a clinical diagnosis of Ebola virus disease;
* patient who consent to participate in the study.

Exclusion Criteria:

* negative RT-PCR tests for Ebola virus
* age \<2 years
* state of shock upon admission
* onset of fever for more than 6 days
* Glasgow Coma Scale \<12
* known contraindications to administration of amiodarone
* positive for HIV antibodies.
iCBT for Children and Adolescents With Obsessive-compulsive Disorder II

Internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms and an age of 6 to 18 years. Sessions are verified with teleconferencing with an psychotherapist, children and their parents. The psychotherapy is supported by an App and a wristband to obtain psychophysiological data. The investigators have already successfully performed a feasibility study.The goal of the current proposal is to develop an internet and smart phone delivered CBT (iCBT) for the treatment of pediatric OCD on the bases of the feasibility study. Internal testing on iCBT therapy package and developmental workchanges has been done. The investigators are now evaluating effectiveness in an RCT.

In this study the investigators test effectiveness of an internet-based therapy approach for children with obsessive-compulsive disorders in an RCT design with a waiting control group. The investigators are planninng the investigation of 20 patients in each group.Therapy is verified by experts via teleconferences and a therapy app. Outcomes for the treatment group are evaluated before randomization (baseline, t0), 16 weeks (end of treatment, t1), 32 weeks (follow-up 1, t2), and 48 weeks after randomization (follow-up 2, t3). For the waiting list-group, outcomes are measured before the first randomization (baseline), at 16 weeks (waiting list period), 32 weeks (end of treatment), 48 weeks after the first randomization (follow-up I) and 64 weeks after the first randomization (follow-up II).

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents (ages 6-18) with a primary DSM-5 obsessive-compulsive disorder and at least 1 primary caretaker
* German-speaking (child \& caretakers)
* Family home equipped with broadband connection and appropriate computer, monitor, HD webcam, and speaker and smart phone
* written informed content of the child and his caretaker
* OCD as highest treatment priority

Exclusion Criteria:

* IQ below 70
* not speaking and understanding German
* A psychiatric comorbidity that makes participation clinically inappropriate (for example, primary anorexia nervosa), depression with suicidality, psychosis or any other psychiatric disorder that requires acute treatment
Pharmacokinetics and Safety of Regorafenib (BAY73-4506) in Cancer Subjects With Severe Renal Impairment

To characterize the pharmacokinetics and safety of regorafenib in cancer subjects with severe renal impairment when compared to the Control group (cancer subjects with normal or mildly impaired renal function)


Eligibility Criteria:
Inclusion Criteria:

* Subjects with histologically confirmed, locally advanced or metastatic, refractory solid tumors who are not candidates for standard therapy
* Male or female subject ≥ 18 years of age
* Women of childbearing potential must have a negative urine pregnancy test performed within 7 days before start of study treatment
* Life expectancy at least 8 weeks
* Adequate bone marrow, and liver function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
* For subjects with NORMAL OR MILDLY IMPAIRED RENAL FUNCTION (Control group); to be tested within 7 days of starting the study treatment:

  * Estimated creatinine clearance (CLcr) ≥ 60 mL/min as calculated using the Cockcroft-Gault equation
* For subjects with SEVERELY IMPAIRED renal function; to be tested within 7 days of starting the study treatment:

  * CLcr 15-29 mL/min as calculated using the Cockcroft-Gault equation

Exclusion Criteria:

* Symptomatic metastatic brain or meningeal tumors
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
* History of organ allograft
* Non-healing wound, skin ulcer, or bone fracture
* Pheochromocytoma
* Uncontrolled concurrent medical illness including uncontrolled hypertension
* History of cardiac disease
* Pleural effusion or ascites that causes respiratory compromise
* Interstitial lung disease with ongoing signs and symptoms at the time of screening
* Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication
* Subjects with evidence or history of bleeding diathesis; any hemorrhage or bleeding event NCI-CTCAE Grade ≥ 3 or higher within 4 weeks of start of investigational treatment
* Dehydration NCI-CTCAEversion 4.0 Grade ≥ 1
* Unresolved toxicity higher than NCI-CTCAE version 4.0 Grade 1 attributed to any prior therapy/procedure (excluding alopecia or anemia or grade 2 neuropathy that is not reversible due to oxaliplatin)
* Seizure disorder requiring anticonvulsant therapy (such as steroids or anti-epileptics)
* For subjects with SEVERELY IMPAIRED renal function:

  * Renal failure requiring hemo- or peritoneal dialysis
  * Acute renal failure
  * Acute nephritis
  * Nephrotic syndrome
Augmented Reality Assisted Lung Nodule Localization: a Multicentered, Prospective, Randomly Controlled, Non-inferiority Trial

With the popularization of CT screening, the detection rate of small lung nodules has greatly increased. Therefore, the clinical thoracoscopic lung nodule biopsy and sub-lobectomy for radical resection of lung cancer are greatly required. Accurate resection of lung nodule depends on precise localization of pulmonary nodules. However, preoperative CT-guided Hook- wire positioning under local anesthesia, which is the current primary localization method, requires high equipment and expense, and may cause physical and mental trauma to the patient. Augmented reality (AR) is an innovative technology that superimpose a virtual scene into the real environment by fusing images, videos, or computer-generated models with patients during surgical operations. It can visually display the anatomical structures of organs or lesions, which significantly improves surgical efficiency. This project intends to use AR technology to localize the solitary pulmonary nodule (SPN) before surgery, compared with CT-guided Hook-wire localization. Compared with the localization of SPNs under CT guidance, AR-assisted localization technology apparently is less time-consuming and can be performed immediately before surgery under general anesthesia, lessening pain, reduce costs of time and equipment, increase the success rate of sub-lobectomy, and improve the overall efficiency of surgical treatment of pulmonary nodules.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years inclusive;
2. No distant metastasis in preoperative clinical assessment;
3. The attending physician's assessment confirms the need for lung nodule localization in patients undergoing sublobar resection;
4. Target lung nodule diameter is no more than 2 cm;
5. The inner edge of the target nodule is at least 2 cm away from the pulmonary artery or pulmonary vein;
6. Non-pleural surface nodules;
7. Preoperative ECOG performance status score of 0/1;
8. Voluntarily participating in this study and signing an informed consent form.

Exclusion Criteria:

1. More than two lung nodules need to be removed at the same time.
2. The target node is located in the scapular region. Because percutaneous localization is obstructed by the scapula, percutaneous localization of pulmonary nodules is not suitable for such patients.
3. Patients with chronic pain issues or those who have been taking pain medications for an extended period.
4. Patients have uncontrollable mental illness and cannot make subjective assessment.
Natural Course and Prognosis of Hospitalized Patients With Cirrhosis

The aim of this prospective study is to evaluate the natural course and prognosis of hospitalized patients with liver cirrhosis.

The aim of this prospective study is to collect data on hospitalized patients with liver cirrhosis at four institutions in Korea (Kangbuk Samsung Hospital, Hallym University Dongtan Sacred Heart Hospital, Chosun University Hospital, and National Medical Center). If patients agree to participate in this clinical trial, the patients' data (such as age, sex, height, weight, nutrition status \[RFH-NPT\], history of medication, laboratory findings, endoscopic findings, and radiologic findings) will be collected in a research database. The research database will be updated, every 6 months, to include data on patients' disease outcomes and follow-up care.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with liver cirrhosis
* Admission to the hospital because of cirrhotic complications such as uncontrolled ascites, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, hepatocellular carcinoma, acute kidney injury, bacterial infection, acute liver failure, and etc.

Exclusion Criteria:

* Admission to the hospital without cirrhotic complications
* Patients who refuse the follow-up of outpatient department
Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease

Interleukin-1 blockade for the treatment of heart failure in patients with advanced chronic kidney disease (End-stage renal disease and Heart fAilure - Anakinra Remodeling Trial) is a Phase 2, single-arm trial designed to estimate the effect of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, on cardiorespiratory fitness in patients with advanced chronic kidney disease and heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* 18 years or older
* Chronic heart failure
* Left ventricular ejection fraction less than 50%
* C-reactive protein greater than or equal to 2 mg/L
* Maintenance hemodialysis with a biocompatible membrane, acceptable dialysis adequacy (Kt/V \> 1.2), and receipt of a stable hemodialysis prescription for at least 4 weeks OR chronic kidney disease stage IV/V (estimated glomerular filtration rate \<30 mL/min/1.73m2)

Exclusion Criteria:

* Inability to complete maximal cardiopulmonary exercise testing
* Need for urgent or emergent care
* Recent use of immunosuppressant, anti-inflammatory therapies or active rheumatologic disease
* Allergy to rubber, latex, Escherichia coli or anakinra
Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

This study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of deucrictibant and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of deucrictibant with placebo.

In Part I of the study, patients in non-attack state receive the assigned active single dose of deucrictibant at the study center to assess pharmacokinetics (the way the body absorbs, distributes, and gets rid of the drug) and safety. In Part II of the study, patients self-administer blinded study drug at home to treat three HAE attacks with deucrictibant or placebo (cross-over).

Eligibility Criteria:
Key Inclusion Criteria:

1. Signed and dated informed consent form
2. Diagnosis of HAE type I or II
3. Documented history of HAE attacks: at least three in the last 4 months, or at least two in the last 2 months prior to screening
4. Reliable access and experience to use standard of care acute attack medications

Key Exclusion Criteria:

1. Pregnancy or breast-feeding
2. Clinically significant abnormal electrocardiogram
3. Any other systemic disease or significant disease or disorder that would interfere with the patient's safety or ability to participate in the study
4. Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal HAE therapy within a defined period prior to enrollment
5. Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus
6. Abnormal hepatic function
7. Abnormal renal function
8. History of alcohol or drug abuse within defined period, or current evidence of substance dependence or abuse
9. History of documented severe hypersensitivity to any medicinal product
10. Participation in any other investigational drug study within defined period
Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery

Spectral domain optical coherence tomography (SD-OCT) was used to determine whether the repair of photoreceptor cone outer segment tips defect is significantly correlated with the visual outcomes after macular hole surgery.

Spectral domain optical coherence tomography (SD-OCT) was used to calculate the mean length of photoreceptor cone outer segment tips (COST) defect on 1, 3, 6, 9, and 12 months after macular hole surgery. The correlation between the mean length of COST defect and the BCVA was determined. Prognostic factors might have influenced for COST repair was also evaluated by multivariable analysis.

Eligibility Criteria:
Inclusion Criteria:

* macular hole patients with surgically-closed hole

Exclusion Criteria:

* macular hole patients failed to close hole
* presence of retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy, and high myopia with an axial length \>27.0mm or refractive error \> -8.0 diopters(D).
* patients who were not followed at least 6 months
Low-carbohydrate Diet in Children with Type 1 Diabetes

The primary aim of this pilot study is to test whether low-carbohydrate diet (LCD) instituted in children/adolescents with type 1 diabetes (T1D) can improve their disease control. The primary objective of the trial is the change in continuous glucose monitoring time in target range 3.9-10.0 mmol/l (TIR) in a 5-week period on LCD as opposed to a 5-week period on recommended carbohydrate diet (RCD).

Secondary objectives are:

Changes in immune parameters during the LCD period; Differences in fecal microbiome during the LCD period; Differences in fecal, serum and urine metabolome during the LCD period;


Eligibility Criteria:
Inclusion Criteria:

* T1D diagnosed according to the ADA (American Diabetes Assocciation) criteria
* T1D duration for at least 1 year prior to the intervention
* continuous glucose monitor (CGM) worn \> 70% time in the month prior to the intervention

Exclusion Criteria:

* last HbA1c \< 40 or \> 70 mmol/mol
* subject has celiac disease
* daily average carbohydrate intake \< 130 g/day from 14 days food record prior to the intervention
* any concomitant disease possibly affecting glucose control
* any chronic medication possibly affecting glucose control
Use of NovoSeven® in Active Variceal Bleeding

This trial is conducted in Asia and Europe. The trial is planned to investigate the effectiveness and safety of NovoSeven® in patients with advanced cirrhosis and active variceal bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Variceal bleeding
Mechanism of IL-10 Pathway-mediated Regulatory B Cell Dysfunction in Osteoarthritis

Our previous work has shown that Treg function is impaired in OA patients, but the cause of Treg deficiency has not been investigated. Since Breg has been shown to promote Treg differentiation and tissue repair, it is highly likely that the absence of the immunomodulatory effect of Breg in OA patients leads to impaired Treg differentiation. Based on the above data, we hypothesized that Breg plays a protective role in the course of OA by regulating T cell composition and promoting Treg differentiation through the secretion of anti-inflammatory factor IL-10


Eligibility Criteria:
Inclusion Criteria:Patients who met the American College of Rheumatology diagnostic criteria for OA

-

Exclusion Criteria:

* Patients with trauma, other forms of arthritis such as rheumatoid arthritis, psoriatic arthritis or spondyloarthritis, and other active inflammatory diseases