cyrilzakka/clinical-trials huggingface dataset:
Cordimax China Post Market Surveillance

Study purpose: This study is a prospective, randomized, controlled multicenter clinical research, which is to assess the effect of Cordimax and Xience V drug-eluting stents as they dealing with all kinds of complex lesions in the real world.

Study group Experimental group: Cordimax® Rapamycin Eluting Coronary Stent System Control group: XIENCE V® Everolimus Eluting Coronary Stent System

The purpose of the post market clinical trial is to evaluate the safety and efficacy of the Cordimax Rapamycin Eluting Coronary Stent System (RECS). The Cordimax will be compared to an active control group represented by the FDA approved commercially available Abbott Vascular XIENCE V® EECS Everolimus Eluting Coronary Stent System.

The post market clinical trial consists of a randomized clinical trial (RCT) in China which will enroll approximately 3660 subjects (2:1 randomization Cordimax® RECS : XIENCE V® EECS) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes \>= 2.5 mm and \<= 4 mm.

All subjects in the RCT will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the XIENCE V® arm of US RCT.

All subjects will have clinical follow-up at 30, 60, 90days, and 1, 2, 3, 4, and 5 years so as to collect the needed data for the subsequent analysis.(Data collecting at 1st year will be conducted in the clinic in order to get the 12 lead ecg result once after out of the hospital) .

Eligibility Criteria:
Inclusion Criteria:

1. age 18 years old or more
2. patients with symptomatic coronary artery disease
3. adapt to the DES treatment according to guide
4. with one or more in diameter of the stenosis of 50% or more coronary artery lesions (refer to 2.5\~4.0 mm) in diameter ;has the objective basis of myocardial ischemia
5. patients willing to participate and sign in research

Exclusion Criteria:

1. Women in pregnancy or lactation
2. Patients are not adapt to the antiplatelet and/or anticoagulant therapy in the expectation
3. Patients were banned to use the antiplatelet and/or anticoagulant therapy
4. Patients have participated in other devices or drugs or other research at the same time, and have not yet reached the end of the research project
5. Patients who must stop clopidogrel to accept a elective surgery
6. patients that the researchers think who are not suitable for stent placement and unable to complete the follow-up, such as the late malignant tumor patients, patients with severe liver and kidney disease, cerebral apoplexy patients, severe infection and severe patients with diseases of the blood system
Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Compared to the Pneumococcal Polysaccharide Vaccine in Adult Kidney and Liver Transplant Patients

Severe Pneumococcal disease, such as bacteremia, meningitis and pneumonia, cause significant morbidity and mortality in both otherwise healthy adult population and in the immunocompromised patients. The incidence rate of invasive pneumococcal disease is considerably higher among organ transplant patients than in healthy individuals. Routine immunization with Pneumococcal vaccine is recommended pretransplant and once 3-5 years after the transplantation. The efficacy and immunogenicity of Pneumococcal polysaccharide vaccine(Pneumovax®) is suboptimal in this patient group. The conjugate Pneumococcal vaccine has been shown to be more immunogenic and safe in some other subgroups of immunocompromised patients. We intend to compare the immunogenicity of repeated dose 13-valent Pneumococcal conjugate vaccine (Prevenar13®)to the existing recommended protocol of Pneumococcal polysaccharide vaccine (Pneumovax®) in adult kidney and liver transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* consecutive new kidney or liver transplantation in our center
* kidney or liver retransplantation in our center

Exclusion Criteria:

* Age \< 18 years
* Previous Pneumococcal vaccination \< 3 years ago
* Febrile illness at the time of vaccination
* Any sign of graft failure or rejection at the time of vaccination
* Splenectomy
* Pregnancy
* Critically ill patient due to any cause, including terminal uncompensated liver disease
Efficacy of Winterized Pistacia Lentiscus Oil in Reducing Purulent Bacterial Overinfection of Pediatric Rhinitis

This study aims to evaluate the efficacy and safety of a medical device containing winterized Pistacia lentiscus oil in reducing symptoms of purulent bacterial overinfection in pediatric rhinitis and the need for antibiotic therapy. The randomized controlled trial will compare the treatment group receiving nasal drops with a control group using saline solution.

This is a prospective, multicenter, randomized controlled trial to assess the therapeutic potential of winterized Pistacia lentiscus oil (WLO) in pediatric patients aged 2 to 10 years with purulent rhinitis. The study will investigate the reduction of rhinitis symptoms, the need for antibiotics, and secondary outcomes including nasal decongestant activity and treatment safety.

Participants will be randomized into two groups: the intervention group will receive 3 drops of WLO per nostril, three times daily for six days, while the control group will use 0.9% saline solution under the same regimen. Clinical evaluations will be conducted by medical staff and parents over six days to record symptom improvement, antibiotic use, and adverse events. The results will contribute to understanding the potential of WLO as a non-antibiotic treatment option for purulent bacterial overinfection in pediatric rhinitis.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 2 to 10 years.
* Clinical symptoms of dense mucosal rhinitis/purulent mucus.
* Onset of symptoms ≤ 5 days before enrollment.

Exclusion Criteria:

* Onset of symptoms \> 5 days before enrollment.
* Presence of neurological, malformative, or immunological pathology.
* Suspected or confirmed allergy to the active substance.
* Use of antibiotics within 48 hours prior to enrollment.
Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain

The purpose of this study is to determine whether a new opioid molecule, NKTR-181, is effective for the relief of moderate to severe chronic low back pain as compared to a placebo.

This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-control treatment of twelve weeks. During the double-blind treatment period, this study will evaluate the analgesic effect of NKTR-181 versus placebo in patients with moderate to severe chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-nursing female aged 18 to 75 years old
* Clinical diagnosis of moderate to severe, chronic non-neuropathic low back pain for at least six months
* Not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics
* Opioid analgesia is necessary
* Currently taking no more than 10 mg morphine sulfate equivalents per day of short acting opioids for 14 days prior to entry
* Females of child bearing potential must be using a highly effective form of birth control. All subjects must agree to use double-barrier contraception during participation in this study and for at least 2 months after the last dose of the study drug.
* Willing and able to provide informed consent

Exclusion Criteria:

* Taking extended release or long-acting opioids within 6 months
* History of hypersensitivity, intolerance, or allergy to opioids
* Compression of spinal nerve root; spinal fracture, tumor, or abscess
* Surgical procedures on the low back in the last 12 months or facet nerve root block or radiofrequency ablation in the last 3 months
* Untreated moderate to severe sleep apnea
A Study of the Pharmacokinetics of Two Formulations of MK-1006 (MK-1006-010 AM1)(COMPLETED)

This study will assess the pharmacokinetics of two formulations of MK-1006. The primary hypothesis of this study is that the MK-1006 area under the curve (0 to infinity) and maximum concentration after administration of a single 80 mg dose of the dry filled capsule (DFC) and film coated tablet (FCT) formulations of MK-1006 will be similar.


Eligibility Criteria:
Inclusion Criteria:

* is a male or a female of non-child bearing potential
* has type 2 diabetes (T2D) and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent(s)
* has been a nonsmoker for at least 6 months

Exclusion Criteria:

* has a history of stroke, chronic seizures, or major neurological disorder
* has a history of major endocrine (except T2D), gastrointestinal, cardiovascular, blood, liver, immune, kidney, respiratory, or genitourinary abnormalities or diseases
* has a history of cancer, except certain skin or cervical cancers or cancer that was successfully treated more than 10 years prior to screening
* has unstable or rapidly progressing diabetic retinopathy and/or neuropathy
* has had an eye infection or other inflammation of the eye in the 2 weeks prior to screening
* has glaucoma or is blind
* has had incisional eye surgery in the last 6 months or laser eye surgery in the last 3 months (Lasik is permitted)
* has a history of type 1 diabetes
* has symptomatic coronary artery disease
* consumes excessive amounts of alcohol and/or caffeine
Regulation of Intraarticular and Synovium-related Biomarkers of Osteoarthritis. Effect of Acute Mechanical Joint Loading

In the present study the microdialysis method is used to investigate biochemical changes within and around the joint simultaneously in both the resting state and in a joint that had been subjected to exercise. The aim of the present study was, by applying the microdialysis technique, to monitor markers of cartilage breakdown and inflammation in 2 different positions of the knee (inside and in the inner part of the knee capsule) in a group of human females with knee osteoarthritis over a period of 3 hours.


Eligibility Criteria:
Inclusion Criteria:

* verified osteoarthritis (x-ray)of the knee, female,

Exclusion Criteria:

* dementia, inflammatory diseases, regular pain medication
The Relationship of Change of Dendritic Cells Fractalkine and P-selectin Patients With Acute Myocardial Infarction

This study evaluates the relationship of change of dendritic cells fractalkine and P-selectin in patients with acute myocardial infarction.

Dendritic cells (DCs) are the most potent antigen-presenting cells, with the unique ability to initiate a primary immune response to certain antigens by activation of "naive" T cells, and are actively related to the process of atherosclerosis. Two DC subsets, myeloid DCs (mDCs) and plasmacytoid DCs (pDCs), were identified in humans. In our previous study, the investigators found that change of dendritic cells and fractalkine in patients with acute myocardial infarction. At the same time, the level of P-selectin increased. In addition, the interaction of dendritic cells and P-selectin promotes the progress of atherosclerosis. In this study, the investigators want to see whether the balance between mDCs and pDCs is altered in patients with acute myocardial infarction. sP-selectin is one of the members of the family of proteins, mediate leukocyte adhesion and rolling in vascular endothelial, studies have shown that in patients with unstable angina and acute myocardial infarction in serum sP-selectin protein increased significantly, showed that sP-selectin associated with the activity of coronary heart disease, causing plaque instability.However, there is few relevant studies about the relationship of dendritic cells and P-selectin in patients with acute myocardial infarction. This study valuates the relationship of dendritic cells and P-selectin in patients with acute myocardial infarction

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as STEMI.
* with left ventricular ejection fraction（LVEF）\>=45%
* written informed consents are obtained.
* admitted within 24 hours after chest pain attacked.

Exclusion Criteria:

* Obvious blood system diseases.
* Combination with other organs function failure: severe liver dysfunction, severe renal insufficiency,severe heart failure (NYHA class 3 and 4), acute or chronic infectious diseases, disease of immune system, asthma, malignant tumor, other advanced disease, etc.
* Pregnant women and planned pregnancy women.
* With drug allergy or contraindications.
* refusal to sign the informed consent
Clinical Trial of the Femtosecond Laser System VisuMax for Refractive Correction of Hyperopia by Means of Lenticule Extraction

This is a feasibility and clinical evaluation study of the VisuMax femtosecond laser for refractive correction of hyperopia using the small incision lenticule extraction (ReLEx smile) method.

In ReLEx® the VisuMax femtosecond laser creates two interfaces that define a refractive lenticule of stromal tissue. In ReLEx® FLEx, the upper interface is converted into a LASIK flap by the creation of a sidecut. The LASIK flap is lifted and the lenticule can be removed to correct the refractive error by tissue subtraction. In ReLEx® smile, the lenticule is dissected and removed through a small 2-3mm incision without the need to create a whole flap.

The aims are i) to optimize the VisuMax settings for lenticule separation ii) to optimize the lenticule geometry iii) to assess the safety, efficacy and stability of the treatment


Eligibility Criteria:
Inclusion Criteria:

* older than 21 years of age,
* maximum hyperopic meridian between +1.00D and +7.00D
* astigmatism up to 6D
* CDVA of:

  1. 20/200 or worse in the eye(s) being treated for Phase I
  2. Between 20/200 and 20/100 in the eye(s) being treated for Phase II
  3. Between 20/40 and 20/60 in the eye(s) being treated for Phase III
  4. 20/25 or better for Phase IV
* total uncut stromal thickness of more than 300 µm
* no previous refractive surgery,
* no ocular disease,
* normal corneal topography,
* contact lens wearers have to stop wearing hard contact lenses at least 4 weeks and soft contact lenses 2 weeks prior to pre-examination,
* willing to attend follow-up examinations within the scope of the clinical investigation,
* able and willing to sign the informed consent

Exclusion Criteria:

* patients who are not being able to lie flat in a horizontal position,
* patients who are not being able to understand and give informed consent,
* pregnant or nursing women (or women who are planning to became pregnant during the clinical investigation),
* diagnosis of an autoimmune disease (e.g. AIDS), connective tissue disease or diabetes,
* treatment with medications such as steroids or immune-suppressants,
* herpes simplex or herpes zoster keratitis,
* all standard medical exclusion criteria for LASIK
Comparison of Body Hydration State in Hemodialysis Patients

Estimation of hydration state in dialysis patients is a major challenge in clinical practice. Although many methods have been studied, none have been established yet for clinical routine practice.

The investigators have developed a method, using segmental and calf bioimpedance spectroscopy (cBIS) techniques to measure body hydration. The device we used based on the FDA-approved Hydra 4200 (Xitron Technologies, San Diego, CA). The Hydra 4200 was initially developed to measure whole body and segmental body fluid volumes but Hydra is approved only for measuring healthy subjects. The cBIS monitors hydration state by continuously measuring change in resistance and resistivity in the calf during hemodialysis (HD) or it can be used for simple measurement before, during and after dialysis. Preliminary results in clinical studies have shown that optimal hydration state of HD patients may be determined by the calf method. This study aims to compare the Hydra 4200 to two other devices: the FDA approved ZOE (100 kHz) Fluid Status Monitor (Noninvasive Medical Technologies, Inc, Las Vegas) and a modified version ZOE 5 kHz. The modified ZOE monitor (ZOE (5 kHz)) delivers frequency of 5 kHz and 0.8 mA current instead of 100 kHz and 2 mA.

The subjects of this study include a group of hemodialysis patients and a group of healthy controls. The healthy controls are used to identify a normal range within the healthy population for each method. Each hemodialysis patient will be studied twice in different hydration state. The study will not change the procedure of the patient's dialysis treatment. Since all devices are based on noninvasive bioimpedance technique, this study has minimal risk.


Eligibility Criteria:
Inclusion Criteria:

* Clinically stable

Exclusion Criteria:

* Implants including pacemakers, implantable pumps, artificial joints
* Limb amputations
* Pregnancy
* Simultaneous participation in another clinical study except observational trials.
Incidence of Uterine Cesarean Scar Niche After Cesarean Delivery

To assess the incidence of cesarean scar niche and its risk factors in a prospectively collected population.

It will be carried out in Gynecology and Obstetrics department in Beni-Suef University Hospital using Ultrasound:

Six months after the cesarean delivery, participants will be invited to the gynecologic outpatient clinic or department for ultrasound (US) examination to detect the presence of the niche.

Women without contraception will be examined during the follicular phase of the menstrual cycle to avoid an eventual early pregnancy. Otherwise, a random phase of the menstrual cycle will be accepted. Women who are pregnant at the time of US will be excluded. Women will be examined in the lithotomy position with an empty bladder. The uterus will be examined in a standardized way, with trans-vaginal US performed first.

For the diagnosis of cesarean scar niche (defined as an anechoic defect in the anterior wall of the lower uterine segment, communicating with the endometrial cavity),we will use a predetermined definition of a defect at least 2.0 mm deep

Eligibility Criteria:
Inclusion Criteria:

1. Delivery by cesarean section.
2. More than 6 months after delivery.
3. Cesarean section by senior resident or assistant lecturer.

Exclusion Criteria:

1. Single layer technique in uterine closure.
2. Uterine anomaly.
Therapy Program for Academic Skills in Children With Intellectual Disability

The aim of this study is to investigate the effect of a physical and occupational therapy program on academic skills in a sample of Egyptian children with intellectual disability. It also aims to provide a program based on physical and occupational therapy activities and techniques to develop children's basic abilities through play to make learning more enjoyable

This study hypothesis

1. There are statistically significant differences between the mean scores of the children of the experimental group in the pre and post measurements on the academic skills scale for children with mental disabilities and its sub-components in favor of the post measurement.
2. There are no statistically significant differences between the mean scores of the children of the experimental group in the post and follow-up measurements on the academic skills scale for children with mental disabilities and its sub-components.

RESEARCH QUESTION:

What is the effect of a physical and occupational therapy program in improving academic skills (reading - writing - arithmetic) in a sample of children with mild intellectual disabilities? The study should include 20 children diagnosed with mild intellectual disability according to Stanford Binet scale 5th edition between the age of 8 to 10 years old from both sexes recruited from Noor Al-Sabah Association for the Care and Rehabilitation of People with Intellectual Disabilities from children with mild mental disabilities

Eligibility Criteria:
Inclusion Criteria:

1. The child should be between 8 and 10 years of age of both sexes
2. The child should be of mild intellectual disabilities according to Stanford Binet scale 5th edition
3. The child should not be suffering from any apparent physical deformity in upper limbs, lower limbs or spine
4. The child should not suffer from any visual or auditory disorder

Exclusion Criteria:

1. Children out of age range
2. Children with moderate or severe intellectual disabilities
3. Children with physical deformities in upper limb, lower limb or spine
4. Children suffering from visual or auditory disorders
5. Children of parents who refuse to sign the consent form
Clinical Study to Assess the Performance of the Dialyzer With Endexo™

Endexo™ is an additive that is blended into the fiber solution during manufacturing of the hemodialyzer hollow fibers. The intended purpose of the additive is to increase blood compatibility in the finished dialyzer, which is referred to as the "dialyzer with Endexo."

This is a prospective, sequential, multi-center, open-label study with subjects on thrice-weekly (in-center) hemodialysis (HD). After a Screening Period, there will be 12 hemodialysis treatments on the Optiflux dialyzer (Optiflux Period), followed by 38 HD treatments on the dialyzer with Endexo (Endexo Period), and then a Follow-up Visit. The study population will consist of End-Stage Renal Disease ESRD subjects who are a minimum of 22 years of age. The primary objective of the study is to collect data on the performance of the dialyzer with Endexo when used to perform hemodialysis (HD) in End-Stage Renal Disease (ESRD) subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Must be an adult, older than 22 years of age.
2. Has been prescribed in-center thrice-weekly HD continuously for at least 180 days prior to the date of signed informed consent
3. Has been prescribed the Optiflux F160NR dialyzer continuously for at least 30 days prior to the date of signed informed consent
4. Has a prescribed HD treatment time ≥180 minutes (3 hours) and ≤270 minutes (4.5 hours)
5. Has been on heparin anticoagulation for dialysis and has had no change in heparin prescription within 14 days prior to the date of signed informed consent
6. Has a most recent single pool Kt/V (spKt/V) ≥1.2 within 45 days prior to the date of a signed informed consent
7. Has a most recent hemoglobin ≥9 g/dL within 45 days prior to the date of a signed informed consent
8. Has a most recent platelet count ≥100,000/mm3 within 45 days prior to the date of a signed informed consent
9. A female of childbearing potential must have a negative serum pregnancy test at the time of screening and agree to use an acceptable method of contraception during the study

Exclusion Criteria:

1. Use of citric acid concentrate (such as Citrasate®) at the time of signed informed consent
2. Known allergic reactions to Endexo
3. Hospitalization within 30 days prior to the date of signed informed consent
4. Presence of active malignancy, congestive heart failure New York Heart Association (NYHA) Class III or IV, or liver cirrhosis
5. Are receiving or have received chemotherapy / radiation therapy / plasmapheresis therapy within 90 days prior to the date of signed informed consent
6. Are receiving antibiotics or have used antibiotics within 14 days prior to the date of signed informed consent
7. Are currently enrolled in or have completed any other investigational product study within 30 days prior to the date of signed informed consent
8. Has a life expectancy of less than 1 year