cyrilzakka/clinical-trials huggingface dataset:
Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices

The Remote Alert Pathway to Optimize Care of Cardiac Implantable Electrical Devices (RAPTOR-CIED) Study is a pragmatic, multi-center, randomized trial with 1:1 patient-level randomization comparing the safety and effectiveness of alert-driven care versus guideline-based care for patients with wireless cardiac implantable electrical devices (CIEDs).

The study will be conducted in 2 phases: a Feasibility Phase and a Main Phase. This registration outlines the goals and design features of the Feasibility Phase of the study.


Eligibility Criteria:
Inclusion Criteria:

1. Adult aged \> 18 years
2. Clinically stable by investigator assessment
3. Has a newly implanted or existing wireless CIED: single, dual-chamber, biventricular, subcutaneous/extravascular, and leadless systems are all eligible, including pacemakers or implantable cardioverter-defibrillators (ICDs)
4. CIED is from one of the 4 major CIED manufacturers in the US market (99% of implants in the US): Medtronic, Boston Scientific, Abbott, Biotronik
5. Currently enrolled in remote monitoring as part of standard of care
6. Primary clinical electrophysiology follow-up at the enrolling center
7. Understands spoken and written English, Spanish, or Portuguese
8. Has sufficient cognitive function to answer standardized questions about study rationale and procedures.

Exclusion Criteria:

1. Presence of insertable cardiac monitor, either in isolation or in combination with any other CIED
2. Listed for cardiac transplantation prior to enrollment (N.B. if a patient becomes listed for transplantation during the study, they may continue study participation)
3. Participation in another study related to novel CIED technology or remote monitoring.
A Registry Study of Biomarkers in Heart Valve Disease

Valvular Heart Disease, impacting 2.5% of the population, is predominantly observed in the elderly and is on the rise. The primary conditions within this category are Aortic Stenosis and Mitral Regurgitation. These conditions are linked to considerable morbidity and mortality, presenting a formidable challenge in optimizing treatment strategies. Pathophysiology of Valvular Heart Disease remains poorly known. The aim of the present study is to identify biomarkers involved in this disease using multi-omics approaches


Eligibility Criteria:
Inclusion Criteria:

* Patients clinically diagnosed with heart valve disease in Beijing Anzhen Hospital

Exclusion Criteria:

* Age \< 18 years
* Failure to obtain medical records and ultrasound data
* Refuse follow-up
Gastrointestinal Anastomosis Using MonoPlus® Suture

The primary aim of this study is to collect clinical data on the performance of MonoPlus® suture applied in routine clinical practice. Diverse parameters are to be used to assess the safety and efficacy of MonoPlus® suture for gastrointestinal anastomosis construction.

This study has been designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity.


Eligibility Criteria:
Inclusion criteria

* Adult patients undergoing an elective open or laparoscopic primary tumor resection within GI tract (stomach, small intestine, large intestine , colon and rectum.
* Age ≥ 18 years
* ASA ≤ III
* Written informed consent

Exclusion criteria

* ASA ≥IV
* Emergency operations
* Peritonitis
* Surgical interventions in the pancreas, oesophagus
* Patients with traumatic perforations
* Pregnant and/or breast-feeding women
* Patients who had received chemotherapy within the last 4 weeks or radiotherapy on the treated region within the last 2 weeks
* Patients who were receiving immunosuppressant therapy
Effect of Melatonin on Cardiovascular and Muscle Mass and Function in Patients With Heart Failure

The main aim of this study is to investigate the effect of melatonin on clinical outcome, quality of life, and cardiovascular function of the patients with heart failure, as well as its effect on their skeletal muscle mass and function.

People with heart failure (HF) suffer from various comorbidities and complications which their management is as important as treatment of HF per se. An important complication of the HF is progressive decrease in muscle mass and function known as muscle wasting or sarcopenia. Prevention, diagnosis, and treatment of muscle wasting is emphasized to improve prognosis and quality of life of the patients with HF. Melatonin is a natural hormone which is secreted from pineal gland and is involved in circadian rhythm control. Recent data delineates more important roles for melatonin in cellular metabolism and apoptosis, as well as acting as an antioxidant and anti-inflammatory agent in the body. Experimental studies show that melatonin can have a beneficial role in muscle wasting in several chronic conditions such as heart failure. Furthermore melatonin has been shown to have valuable effects on cardiovascular health, blood pressure, and endothelial function and it might benefit patients with heart failure. In this study the effect of melatonin on clinical outcome and quality of life of the patients with HF and their echocardiographic parameters, muscle mass, muscle function, inflammatory biomarkers, serum metabolic parameters, and serum oxidative stress markers will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Systolic heart failure with ejection fraction \< 40, either ischemic or dilated cardiomyopathy (DCM)
* Symptoms and medications of HF have been stable for at least three months
* NYHA class II-III
* Willing to participate in the study and providing informed consent

Exclusion Criteria:

* Chronic comorbidities: insulin dependent diabetes, renal failure (GFR \< 30 mL/min per 1.73 m2), uncontrolled endocrine disease, end-stage liver disease, rheumatological disease, chronic obstructive pulmonary disease (class D according to GOLD classification), morbid obesity (BMI \> 35)
* Acute ischemic heart event or revascularization procedure in the last month
* Regular supervised exercise or ingestion of muscle hypertrophy supplementations in the last three months
* Vegetarian diet or sever restriction of protein in the diet in the last three months
* Occurrence of melatonin related adverse effects
A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis

This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and tolerability of vismodegib in combination with pirfenidone in participants with idiopathic pulmonary fibrosis (IPF) currently being treated with pirfenidone.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of IPF 5 years from time of screening, confirmed at baseline
* Tolerated dose of pirfenidone 1602-2403 mg once daily (QD) for a minimum of 24 weeks required prior to and during screening
* Greater than or equal to (\>=) 50 percent (%) and less than or equal to (\<=) 100% of predicted forced vital capacity (FVC) at screening
* Stable baseline lung function as evidenced by a difference of less than (\<) 10% in absolute FVC measurements (in liters) between screening and Day 1/Visit 2 prior to enrollment
* \>=30% and \<=90% of predicted diffusion capacity of the lung for carbon monoxide at screening
* Agree to use protocol defined methods of contraception
* Male participants must agree not to donate semen during the study and for at least 2 months (or as per local requirements) after the last dose of vismodegib
* Agree not to donate blood or blood products during the study and for at least 9 months (or as per local requirements) after the last dose of study treatment

Exclusion Criteria:

* Prior treatment with vismodegib or any Hh-pathway inhibitor
* Evidence of other known causes of interstitial lung disease
* Hospitalization due to an exacerbation of IPF within 4 weeks prior to or during screening
* Lung transplant expected within 6 months of screening
* Evidence of clinically significant lung disease other than IPF
* Post-bronchodilator forced expiratory volume in 1 second/FVC ratio \<0.7 at screening
* Any clinically significant medical disease (other than IPF) that is associated with an expected survival of \<6 months, likely to require a change in therapy during the study
* Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction \<35%
* Known current malignancy or current evaluation for a potential malignancy
* Known immunodeficiency, including, but not limited to, human immunodeficiency virus infection
* Evidence of acute or chronic hepatitis or known liver cirrhosis
* Creatinine clearance \<=30 milliliter per minute, calculated using the Cockcroft-Gault formula
Study of Tumor Tissue From Patients With Melanoma Treated on Clinical Trial EST-1690

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at tumor tissue samples from patients with melanoma treated on clinical trial EST-1690.

OBJECTIVES:

* To validate the prognostic role of several biomarkers suggested by gene expression profiling and tissue microarray (TMA) studies (e.g., NCOA3, SPP1, and RGS1) on the outcome associated with melanoma in the EST-1690 cohort using IHC analysis.
* To examine the potential predictive role of such biomarkers in patients undergoing adjuvant interferon alfa therapy.
* To analyze the correlation between the intensity of biomarker expression and survival of this cohort both in the observation and in the interferon-treated groups.
* To examine the prognostic role of these biomarkers on the outcome associated with melanoma in the EST-1690 cohort using quantitative-PCR.
* To isolate RNA from the primary specimens from patients enrolled in the EST-1690 cohort to assess the expression of genes suggested by cDNA microarray and IHC analyses (e.g., NCOA3, SPP1, and RGS1) as prognostic or predictive markers.

OUTLINE: Samples from the EST-1690 cohort are obtained and analyzed for several biomarkers (i.e., NCOA3, SPP1, and RGS1) via immunohistochemistry and quantitative PCR. RNA is isolated from the specimens to assess gene expression via quantitative PCR.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of melanoma

  * No metastatic disease at diagnosis
* Treated on protocol EST-1690
* Primary tumor tissue specimens available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Study Evaluating the Value of 68Ga-Pentixafor PET Imaging in the Staging of Hematological Tumor, and Comparing It with 18F-FDG PET/CT Imaging

This is a prospective, open-label, single-center clinical study targeting hematological malignancies. 120 patients with a confirmed by pathology of non-Hodgkin's lymphoma or myeloma were included. Qualified subjects will undergo 18F-FDG PET/CT and 68Ga-Pentixafor PET/CT examination. The aim is to To investigate whether 68Ga-pentixafor PET imaging can be used as a reliable complement to 18F-FDG PET imaging for clinical staging, treatment response evaluation, and re-staging of patients with hematological malignancies.


Eligibility Criteria:
Inclusion Criteria:

Ages 18 to 75 years old Confirmed by pathology with NHLs or myeloma Willing and able to follow the study protocol.

Exclusion Criteria:

Children, pregnant or lactating women Severely impaired liver and kidney function (alanine aminotransferase \> 8-10 times the upper limit of normal, serum creatinine 186-442 umol/L) With a history of allergy to contrast media or other drugs
Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma

The purpose of the study is to evaluate the mechanism(s) of action of galiximab in subjects with previously untreated follicular NHL.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent (signed and dated).
* Age equal or greater than 18 at the time of consent.
* Histologically confirmed follicular NHL according to the Revised European American Lymphoma (REAL)/ World Health Organization (WHO) classification (from initial diagnosis) Grades 1,2, or 3a.
* At least 2 malignant lymph nodes of similar size (\>1 cm in minimal dimension) and location that are readily accessible for excisional biopsy at the time of study entry.
* Consent to 1 pretreatment and 1 post-treatment excisional biopsy of accessible tumor.
* Acceptable hematologic, hepatic, and renal function parameters.
* WHO Performance Status equal or less than 2.
* Subjects of reproductive potential must agree to follow accepted birth control methods.

Exclusion Criteria:

* Presence of lymphoma in CNS.
* Previous systemic anticancer treatment for NHL (including but not limited to radiation, myeloablative, or investigational therapy).
* Concurrent treatment with systemic steroids within 14 days of Day 1.
* Evidence of transformed lymphoma.
* Presence of malignancies within 3 years of Study Day 1 (except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer).
* History of HIV infection or AIDS.
* Serious nonmalignant disease.
* Pregnant.
* Inability to comply with study and follow-up procedures.
* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug.
Dasatinib (BMS-354825) in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate

The purpose of this study is to see what effect an investigational drug (BMS-354825) has on subjects who are currently in the myeloid blast phase of chronic myeloid leukemia (CML) and who are either resistant to or intolerant of imatinib mesylate. Another purpose of the study is to see what side effects this drug may have on subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with myeloid blast phase chronic myeloid leukemia
* Subjects who are either resistant or intolerant of imatinib mesylate

Exclusion Criteria:

* Subjects who are eligible and willing to undergo transplantation
* Serious uncontrolled medical disorder or active infection
* Uncontrolled or significant heart problems, such as congestive heart failure, recent heart attack, etc
* Subjects receiving medications that may affect heart rhythm
* Other malignancy/cancer other than CML
* History of significant bleeding disorder unrelated to CML
* Pregnant or breastfeeding women (subjects must avoid becoming pregnant)
* Subjects received imatinib within 7 days, interferon or cytarabine within 14 days, a targeted anticancer medication within 14 days, an antineoplastic agent (other than hydroxyurea or anagrelide) within 28 days, or any other investigation medication in 28 days
* Subject is receiving medications that affect platelet function or an anticoagulant
User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL

Prospective collection of data from medical records, multicenter, post-market clinical follow-up study.


Eligibility Criteria:
Inclusion Criteria:

1. Previously bilaterally implanted with TECNIS Odyssey IOL, following cataract extraction;
2. Enrollment at least 21 days after second eye surgery;
3. Clear intraocular media in each eye;
4. Signed informed consent and data protection documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries;
5. Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures;
6. Ability to understand, read, and write in English

Exclusion Criteria:

1. Concurrent participation in an interventional clinical trial during the time from which the data will be collected;
2. Use of systemic or ocular medication that may affect vision
3. Prior corneal refractive surgery in each eye (i.e., LASIK, PRK, SMILE, RK, CK); NOTE: Limbal relaxing incisions (LRI) are permissible as planned at the time of surgery (intraoperatively) but not postoperatively until after completion of the study visits;
4. Ongoing adverse events that might impact study measurements, as determined by the investigator;
5. Acute or chronic disease or condition, ocular trauma, or surgery that may confound study measurements (e.g., clinically significant macular degeneration, glaucoma, cystoid macular edema, proliferative diabetic retinopathy, keratoconus, etc.);
6. Amblyopia, strabismus, nystagmus in each eye
Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics

An increasing number of studies have reported the use of dexmedetomidine in clinical practice. However, few studies have reported on the intranasal use of dexmedetomidine in radiological procedures The aim of this work is to compare the efficacy and safety of intranasal dexmedetomidine and intranasal midazolam in pediatrics undergoing MRI.

This prospective randomized double-blind clinical trial will be carried out on 60 children undergoing elective MRI in Tanta University Hospitals.

Sixty children will be randomly allocated into two equal groups by computer-generated sequence through sealed opaque envelopes:

Group D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will be sedated with 0.3 mg/kg intranasal midazolam.

Eligibility Criteria:
Inclusion Criteria:

Aged from 2 to 8 years Both sexes ASA physical status I and II Elective MRI.

Exclusion Criteria:

1. Patient's guardian refusal.
2. Body mass index \>30 kg/m2
3. Known allergy to dexmedetomidine or midazolam.
4. Suspected difficult airway.
5. Upper respiratory tract infection
6. Anatomical structural deformity of the nasal cavity.
7. Severe liver or renal impairment.
8. Severe bradycardia or atrioventricular block above II degree type 2.
9. Administration of digoxin or beta blockers
Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans

The creole study is a A Multi-centre, multinational, randomised single-blind, parallel group, three-armed superiority trial which is aimed at comparing the efficacy of three "free" combinations of two anti-hypertensive agents on 24 hour ambulatory systolic blood pressure (ASBP) in black African hypertensive patients.

The CREOLE trial will be performed at ten investigational sites in six countries in Sub-Saharan Africa which include Cameroun, Kenya, Mozambique, Nigeria, South Africa and Uganda. Subjects will be randomised to one of three treatments which are Perindopril plus Amlodipine or Perindopril plus Hydrochlorothiazide or Amlodipine plus Hydrochlorothiazide.Patients will commence treatment at a starting dose of Amlodipine plus Hydrochlorothiazide 5/12.5 mg or Amlodipine plus Perindopril 5/4 mg or Perindopril/Hydrochlorothiazide 4/12.5 mg. These doses will increase at the two months visit, to Amlodipine/Hydrochlorothiazide 10/25 mg or AmlodipinePperindopril 10/8mg or Perindopril/Hydrochlorothiazide 8/25 mg.

The patients will have ambulatory blood pressure monitoring at randomization and at six months and office blood pressure measurements at randomization and at two-month, 4-month and six-month visits.The overall aim is to discover the best combination of front-line anti-hypertensive medications for black patients residing in sub-Saharan Africa.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Sitting SBP ≥140 mm Hg and \< 160 mmHg on one antihypertensive agen or
* Sitting SBP ≥ 150 mm Hg and \< 180 mm Hg on no antihypertensive treatment.

Exclusion Criteria:

* Congestive heart failure (clinically defined).
* Serum creatinine levels greater than 170 µmol/l or estimated glomerular filtration rate (eGFR) \< 30 ml/min.
* History of coronary heart disease (i.e., chronic stable angina, myocardial infarction or acute coronary syndrome).
* History of a stroke or other cerebrovascular accident (i.e. transient ischaemic attack or reversible ischaemic neurological deficit).
* Known or suspected secondary hypertension.
* Any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study.
* Pregnancy or those of child-bearing age who are not taking reliable contraception.
* Patients with a history of intolerance to any of the study medications for example angioedema or dry cough with angiotensin converting enzyme inhibitors.
* Patients on maximum dose of any of the study medications as monotherapy (i.e. amlodipine 10 mg/day or hydrochlorothiazide 25 mg/day or perindopril 8 mg/day)
* Gout.
* Serum potassium \< 3.5mmol/L at screening.
INSTrUCT-SCI: INdependent Observational STUdy of Cell Transplantation in SCI

The investigation is a multi-year observational study following the completion of the open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC cells into 12 subjects with thoracic spinal cord injury.

Subjects will be monitored at routine intervals for safety and preliminary efficacy for 5 years post-transplantation of the Phase I/II investigation CL-N02-SC.


Eligibility Criteria:
Inclusion Criteria:

* Must have undergone HuCNS-SC transplantation as a subject in the Phase I/II trial
* Must be able to provide written informed consent prior to any study related procedures
* Must agree to comply in good faith with all conditions of the study and to attend all required study visits
* Female subjects who are pregnant remain eligible for enrollment, but the MRI examination will not be performed during the pregnancy. Female subjects of child-bearing potential must have a negative urine pregnancy test prior to the MRI examination

Exclusion Criteria:

* Subjects have received or are receiving off-protocol immunosuppressive medications
* Subjects who after completion of CL-N02-SC have entered, or are about to enter any other interventional study
Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea

A Multi-center, Randomized, Placebo-controlled, Double-blind, Cross-over, Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients with Primary Dysmenorrhea


Eligibility Criteria:
Inclusion Criteria:

* Female patients, age between 19 years to 44years
* Patients with menstrual pain over 4 out of 6 menstrual cycles before screening
* Patients with moderate or severe menstrual pain for recent 2 menstrual cycles
* Patients with regular menstrual cycles(28±7 days) for a year

Exclusion Criteria:

* Patients diagnosed or suspected of secondary dysmenorrhea
* Previous adverse reaction or known allergy to NSAIDs
* Breast feeding woman
* Patients who are not willing to use proper contraception during clinical trial period