cyrilzakka/clinical-trials huggingface dataset:
BIOFLOW-III All-comers Orsiro Safety and Performance Registry

This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30%-50%. Such rates of recurrence have serious economic consequences.

Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures.

The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilised on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to BMS with systemic drug administration.

These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease. This observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic coronary artery disease
* Subject has signed informed consent for data release
* Subject is geographically stable and willing to participate at all follow-up assessments
* Subject is ≥ 18 years

Exclusion Criteria:

* Subject did not sign informed consent for data release
* Pregnancy
* Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
* Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
* Currently participating in another study and primary endpoint is not reached yet.
Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy

This open-label, multicenter trial will evaluate the efficacy and safety of treatment with AMN107 in chronic myelogenous leukemia (CML) patients that are resistant and/or intolerant to imatinib mesylate therapy.


Eligibility Criteria:
Inclusion Criteria:

* Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML in blast crisis, accelerated or chronic phase
* Males or females ≥ 18 years of age

Exclusion Criteria:

* Impaired cardiac function
* Acute or chronic liver or renal disease
* Use of therapeutic coumadin
* Central nervous system (CNS) infiltration

Additional protocol-defined inclusion/exclusion criteria may apply.
Effect of Ultrasound-guided Stellate Ganglion Block Combined With Facial Nerve and Glossopharyngeal Nerve Block on the Treatment of Sudden Deafness

Sudden deafness is a sudden, unexplained sensorineural hearing loss of ≥20 dBHL in at least two adjacent frequencies within 72 h. It may be accompanied by tinnitus, a sense of ear congestion, vertigo and other Symptoms.Stellate ganglion block increases the blood flow and blood velocity in the inner ear, keeping the body's vegetative, endocrine and immune functions normal.The branches of the facial and linguopharyngeal nerves are connected to the inner ear, and local injection can nourish the nerves and improve local circulation.


Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for sudden deafness established by the Editorial Board of the Chinese Journal of Otolaryngology, Head and Neck Surgery and the Chinese Society of Otolaryngology, Head and Neck Surgery
* Age 18 to 80 years
* ASA classification Ⅰ\~Ⅲ grade

Exclusion Criteria:

* Acoustic conductance test, vestibular function test, cranial MRI, etc. suggest organic disease
* People with coagulation disorders or on anticoagulation therapy
* Infection at the puncture site
* Severe systemic diseases that cannot cooperate with treatment
Evaluation of SCOUT DS Device in the Diagnosis of Diabetes Mellitus

The primary objective is to identify compare SCOUT DS to random capillary glucose for identification of at-risk subjects with dysglycemia defined by hemoglobin A1C ≥ 6.0%.

The study will complete up to 400 subjects at the clinical site to evaluate the precision and accuracy of SCOUT DS and random capillary glucose for detecting pre-diabetes and undiagnosed type 2 diabetes in subjects at risk but not having a pre-existing diagnosis of type 2 diabetes. A point of care A1c measurement will serve as the reference method for defining pre-diabetes (6.0% ≤ A1c ≤ 6.4%) and diabetes (A1c ≥ 6.5%).

The study will require one visit by each subject to the clinical site. The visit does not require fasting and can be done any time of day. The study (not including the IRB process and recruiting) is expected to last 6 months.

The target cohort for comprises persons at risk for pre-diabetes and/or type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 45 years

OR

Age 18 to 44 years and with one or more of the following risk factors:

* BMI \> 25 kg/m²
* Elevated waist circumference, \> 35 inches for women and \>40 inches for men
* Habitually physically inactive (does not exercise regularly)
* Has a first-degree relative with diabetes
* Ethnicity with elevated risk for type 2 diabetes
* Has delivered a baby weighing \> 9 lb or diagnosed with gestational diabetes
* Hypertension (≥130/≥ 85 mmHg) or being treated for hypertension
* HDL cholesterol level \< 35 mg/dL and/or a fasting triglyceride level ≥ 250 mg/dL or being treated for dyslipidemia with medication
* Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS)
* Had impaired glucose tolerance or impaired fasting glucose on previous testing within the last 3 yrs
* Conditions associated with insulin resistance such as acanthosis nigricans
* History of vascular disease including heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure or peripheral arterial disease

Exclusion Criteria:

* • Under 18 years of age

  * Receiving investigational treatments in the past 14 days
  * Psychosocial issues that interfere with an ability to follow study procedures
  * Conditions that cause secondary diabetes including Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis
  * Diagnosed with any type of diabetes, including type 1 or 2
  * Taking glucose lowering medications with the exception of metformin
  * Known to be pregnant
  * Receiving dialysis or having known renal compromise
  * Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
  * Recent (within past month) or current oral steroid therapy or topical steroids applied to the left forearm; inhaled steroid therapy is not excluded
  * Current chemotherapy, or chemotherapy within the past 12 months
  * Receiving medications that fluoresce\*
  * Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence

The purpose of the study is to evaluate the safety and effects of onabotulinumtoxinA (BOTOX) for the temporary improvement in the appearance of platysma prominence.

Study doctors will randomize participants into 1 of the 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 400 participants will be enrolled in the study in the United States and Canada.

Participants will receive a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study.

Participants will attend regular monthly visits during the study at the study site.


Eligibility Criteria:
Inclusion Criteria:

* Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study specific procedures
* Are willing and able to comply with procedures required in the protocol
* Adult male or female, at least 18 years old at the time of signing the informed consent
* Good health as determined by medical history, physical examination, vital signs, and investigator's judgment

Exclusion Criteria:

* Any medical condition that may put the participant at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
* Participant has an anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)
* Anticipated need for surgery or overnight hospitalization during the study
* Females who are pregnant or breastfeeding and are considering becoming pregnant or donating eggs during the study
* Known immunization or hypersensitivity to any botulinum toxin serotype
* History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months
* Lower facial and neck hair, scarring (e.g., acne), or other abnormal variations that may interfere with photography (such that photograph is not acceptable)
* Tattoos, jewelry, or clothing that cannot be removed, and that obscure the target area of interest
Reactogenicity, Safety and Immunogenicity of a TB/FLU-04L Tuberculosis Vaccine

The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-04L tuberculosis vaccine versus matched placebo in BCG-vaccinated healthy adult subjects aged 18-50 years.


Eligibility Criteria:
Inclusion Criteria:

* Healthy BCG-vaccinated male or female adult 18 through 50 years of age at the enrollment visit.
* Literate and willing to provide written informed consent.
* A signed informed consent.
* Capable and willing to complete diary cards and willing to return for all follow-up visits.
* For females, willing to take reliable birth control measures throughout the entire period of participation in the study.

Exclusion Criteria:

* Clinical, radiological (chest X-ray) or laboratory evidence of active or past TB disease.
* Current or past administration of anti-TB therapy.
* History of contact with TB patients.
* Positive QuantiFERON-TB Gold test.
* BCG vaccination in less than 6 months prior to study.
* Practice of nasal irrigation on a regular basis within the past six months or has engaged in nasal irrigation within two weeks prior to enrollment.
* Recent history of frequent nose bleeds (\>5 within the past year).
* Clinically relevant abnormal paranasal anatomy.
* Recent history (within the past month) of rhino or sinus surgery, or surgery for any traumatic injury of the nose.
* Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever.
* Hypersensitivity after previous administration of any vaccine.
* History of chronic alcohol abuse and/or illegal drug use.
* Any clinically significant abnormal laboratory finding.
* A positive pregnancy test for all women of childbearing potential.
* Administration of immunosuppressive drugs or other immune modifying drugs within 4 weeks prior to study enrollment.
* Acute or chronic clinically significant pulmonary disease, cardiovascular disease, gastrointestinal disease, liver disease, neurological illness, liver disease, blood disease, skin disorder, endocrine disorder, neurological illness and psychiatric disorder as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives.
* History of leukemia or any other blood or solid organ cancer.
* Seropositive for HIV, hepatitis B surface antigen and/or hepatitis C antibodies.
* Receipt of antivirals, antibiotics, immunoglobulins or other blood products within 4 weeks prior to study enrollment or planned receipt of such products during the period of subject participation in the study.
* Participation in another clinical trial within the previous three months or planned enrollment in such a trial during the period of this study.
* Subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol.
Observational Study of Bevacizumab [Avastin] in Patients With Metastatic Colorectal Cancer (AVASTART)

This observational study will assess the treatment duration, progression-free survival, reason for stopping treatment and patient and tumor characteristics of bevacizumab \[Avastin\] treatment in patients with metastatic colorectal cancer. Data will be collected for approximately 34 months. The target sample size is \>300 patients.


Eligibility Criteria:
Inclusion Criteria:

* adult patients =/\<18 years of age
* metastatic colorectal cancer
* patients for whom the physician has prescribed bevacizumab \[Avastin\] for the treatment of 1st line metastatic colorectal cancer
* patients, who have given written informed consent

Exclusion Criteria:

* hypersensitivity to recombinant human or humanised antibodies
* pregnancy or breast-feeding
VR for Pediatric Burn Dressing Changes

This study evaluated a smart phone virtual reality (VR) to manage pediatric burn dressing pain. A randomized controlled trial was conducted among 90 patients (6-17 years). Active VR participants played the game, passive VR group were immersed in the same VR without interactions, and a standard care group served as the control. One researcher administered VR and observed pain while another researcher administered post-trial survey that measured child's perceived pain and VR experience. Nurses were asked to report the clinical utility.


Eligibility Criteria:
Inclusion Criteria:

* children age 6-17 years (inclusive)
* admitted or seen in the outpatient clinic for a burn injury
* spoke English as primary language

Exclusion Criteria:

* a severe burn on the face or head that prevented the utilization of the VR
* cognitive or motor impairment that prevented valid administration of study measures
* visual or hearing impairments that prevented interaction with the VR environment
* did not have a legal guardian present to give consent
Aflo™ Device Trial

This randomised, prospective, controlled parallel study aims to evaluate the role and potential of the aflo™ digital platform for improving asthma control, inhalation technique and adherence in patients who use metred dose inhalers (MDI). The study will recruit 104 patients with uncontrolled asthma in the North-West of Northern Ireland. Fifty two patients will remain on standard care over 24-weeks and 52 will combine standard care with the aflo™ platform. The data collected over a 24-week period will be used to determine 1. whether the aflo™platform improves inhalation technique and user adherence to prescribed medication and 2. Lead to better asthma control and reduced symptoms as measured by the Asthma Control Test (ACT). During the study clinicians will be able to remotely monitor and review user analytics via a clinical dashboard. ACT measurements will be recorded at start and end of study. The study aims to test the functionality and impact of automated inhaler technique with real-time feedback, adherence prompts and air quality data sharing for patients who use metered dose inhalers (MDI) using the newly developed aflo™ digital respiratory management platform.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed as suitable for inclusion by their General Practitioner or asthma nurse.
* Access to WiFi and a smart phone (Android or apple phone with latest version -2) and knowledge of / carer support with using a smartphone.
* For children (parent/ carer must register and provide smart phone access)
* Aged \> 5 years (with carer/ parental consent if \< 17 years old)
* Smart phone user/ willing to use (or parent/ carer) and have access to and knowledge of working a smart phone and WIFI / 4G
* Currently prescribed an inhaled reliever +/- preventer medication via pressurised
* Metered Dose Inhaler (MDI) short acting beta2 agonist (SABA), inhaled corticosteroid (ICS) ICS / long acting beta2 agonist (LABA) MDI +/- spacer
* Adherence/ symptom control issues with medication (as identified by excess use of SABA/ healthcare personnel visits/ calls/ emergency department visit/ hospital admission
* Those who understand written and spoken English

Exclusion Criteria:

* \< 5 years old
* Other major respiratory illness or significant concurrent disease that might prevent completion of the study
Safety and Efficacy Clinical Study of SNS-595 in Patients With Platinum-Resistant Ovarian Cancer

The purpose of this study is to evaluate the objective response rate, safety and identify potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin injection given on a 28-day cycle.

Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
* Completed at least one Platinum Based Therapy (PBT) regimen (carboplatin, cisplatin, or another organoplatinum compound).
* Evidence of platinum-resistant disease, relapse/progression within 6 months of the completion of PBT, or intolerant to PBT (inability to receive PBT due to hypersensitivity reactions to platinum)
* Patients with primary platinum-resistant disease are allowed to receive no more than one nonplatinum cytotoxic regimen and no more than one noncytotoxic regimen for the management of recurrent or persistent disease after the development of primary platinum-resistance.
* Measurable disease per GOG-RECIST criteria
* GOG Performance Status of 0 or 1

Exclusion Criteria:

* Radiotherapy, chemotherapy, and hormonal, cytokine, or targeted therapy, within 3 weeks (nitrosurea or mitomycin C within 6 weeks) prior to the anticipated first day of treatment.
* Monoclonal antibody therapy within 4 weeks prior to clinical study entry
* Unresolved or impending bowel obstruction
* Other active malignancies or other malignancies within the last 12 months except nonmelanoma skin cancer or cervical intraepithelial neoplasia
* Prior radiotherapy to more than 25% of the marrow space
* Requiring hemodialysis or peritoneal dialysis
* Myocardial infarction or cerebrovascular accident/transient ischemic attack within the 6 months prior to the anticipated first day of treatment
* Thromboembolic event (deep vein thrombosis \[DVT\] or pulmonary embolus \[PE\]) within 28 days prior to the anticipated first day of treatment
* History of active CNS metastases
* Any other medical, psychological, or social condition that would contraindicate the patient's participation in the clinical study due to safety or compliance with clinical study procedures.

Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if you meet all study criteria.
Applying Artificial Intelligence to Optimize Early-stage Hepatocellular Carcinoma Treatment Based on Multi-modal Image

This study intends to establish two prognostic models based on contrast-enhanced ultrasound (CEUS) and dynamic enhanced magnetic resonance (DE-MRI) multimodal images: prognostic model of liver cancer patients after hepatectomy and prognostic model of liver cancer patients after radiofrequency ablation. Combined with artificial intelligence imaging omics, traditional imaging omics and clinical information, to predict and compare the prognosis of two different treatment methods for early liver cancer, so as to realize the individual selection of treatment methods for early liver cancer patients


Eligibility Criteria:
Inclusion Criteria:

* Primary single hepatocellular carcinoma confirmed by histology or cytology, with a maximum diameter ≤5.0 cm;

  * Good liver function, Child-Pugh grade A;

    * No serious dysfunction of heart, lung, kidney and other important organs ④ Liver resection or radiofrequency ablation was performed in our hospital, and the study protocol and follow-up procedure were followed.

Exclusion Criteria:

* Patients who cannot perform DCE-MRI examination due to metal implants in the body ② Patients who had received other treatment before DCE-MRI or CEUS;

  * Invisible lesions, diffuse lesions or poor DCE-MRI/CEUS image quality under CEUS; ④ Drug abuse, clinical or psychological or social factors that make informed consent or study implementation affected.
Effectiveness and Cost-Efficiency of Aquatic Exercise for Management of Osteoarthritis

The purpose of this study was to estimate the cost and outcomes of the Arthritis Foundation aquatic exercise classes.

* DESIGN. Randomized trial of 20-week aquatic classes.
* SUBJECTS AND METHODS. Recruited 249 adults from Washington State aged 55 to 75 with a doctor-confirmed diagnosis of osteoarthritis
* MEAURES. The Quality of Well-Being Scale (QWB), Current Health Desirability Rating (CHDR), Health Assessment Questionnaire(HAQ), Center for Epidemiologic Studies-Depression Scale (CES-D), Perceived Quality of Life Scale (PQOL)


Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed diagnosis of osteoarthritis from a physician
* Aged 55 to 75
* Not currently exercising, defined as engaging in an average of less than 60 minutes of exercise/week during the last month
* Permission of the subject's primary physician to participate in the aquatic class
* Not currently enrolled in another medical study
* Not scheduled for joint replacement surgery during the study period
* Living in an area where Arthritis Foundation aquatic programs were offered
* Willingness to be randomized and to commit to the 5-month study period