cyrilzakka/clinical-trials huggingface dataset:
A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices

This prospective, single-arm, multi-center study will collect clinical data in a post-market setting for the pediatric population (general surgical procedures) and adult population (general, gynecological, urological, and thoracic surgical procedures). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the HARMONIC 1100 Shears and Generator G11 instructions for use.


Eligibility Criteria:
Inclusion Criteria:

Pediatric population:

1. Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU;
2. Less than 18 years of age at the time of procedure; and
3. The subject's parent/legal guardian must be willing to give permission for the subject to participate in the study and provide written informed consent for the subject. In addition, assent must be obtained from pediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the study. If the pediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the study), the parent/legal guardian's written informed consent for the subject will be acceptable for the subject to be included in the study.

Adult population:

1. Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU;
2. Willingness to give consent and comply with all study-related evaluations and visit schedule; and
3. At least 18 years of age.

Exclusion Criteria:

Preoperative

1. Physical or psychological condition which would impair study participation;
2. Female subjects, of childbearing age, who are pregnant; or
3. Enrollment in a concurrent interventional clinical study that could impact the study endpoints.

Intraoperative

1. The HARMONIC 1100 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure.
Evaluation of NT PRO BNP Guided Therapy on Hospitalization Rate and Mortality in Patients With Chronic HF NYHA II-IY

To use continuous measurement of NT Pro BNP level as guide in therapy patients with CHF.

Group of 100 patients with CHF, NYHA II-IY will be followed for 1 years in outpatient clinic of our hospital for hospitalization, death, 6 min walking protocol, number of decompensation as a primary end point. 50 patients will be treated according usual practice in outpatient clinics and in 50 patients will be additionally used level of NT Pro BNP as additional parameter.If level NT Pro BNP will be goes down will not be changes in treatment regiment. If level of NT Pro BNP will be increased treatment will be intensified.At the end of 1 year follow up we will compare the result of two strategies.

Eligibility Criteria:
Inclusion Criteria:

* Patient older 18 y.old with CHF NYHA II-IY.

Exclusion Criteria:

* All conditions with life expectancy less than 2 years.
Adolescent Mothers, Grandmothers, Breastfeeding and Complementary Feeding

The purpose of this study is to determine whether counseling sessions on breastfeeding for adolescent mothers and their grandmothers in the maternity ward and at home are effective in to improve the exclusive and total breastfeeding rates during the first six month, as well as the convenient timing of supplementary feeding introduction.

Despite the recognized value of exclusive breastfeeding during the first months of a child's life and efforts for promoting this practice, rates for this pattern of breastfeeding in Brazil are below those recommended by the World Health Organization(WHO), which advocates exclusive breastfeeding during the first 6 months. The last national survey about the prevalence of breastfeeding revealed a median duration of 10 months. However , the length of exclusive breastfeeding was only 23 days.

A lot of studies identified maternal age as predictor of breastfeeding. In African, Asian, Latin American and the Pacific societies, older women, or grandmothers,traditionally have considerable influence on decisions related to maternal and child health at the household level.

Considering all that, interventions intended to increase frequency of breastfeeding, particularly exclusive breastfeeding. However, there are few studies on this subject.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent mothers
* Mothers living in the city of Porto Alegre
* Healthy nontwin newborns with birth weight equal or greater than 2500g

Exclusion Criteria:

* Mothers living with mother-in-law
* Mother-infant pairs that were unable to stay together due to a health concern in either the mother or infant
* Mammaplasty reductive
A Qualitative Study to Assess the Content Validity of the Prescription Opioid Misuse and Abuse Questionnaire

The purpose of this study is to evaluate the patient usability and reliability of the POMAQ survey to evaluate opioid misuse and abuse among adults with chronic moderate to severe pain, including patients who are opioid abusers, non-abusers, as well as non-opioid users

The Food and Drug Administration (FDA) has requested, as part of a post-marketing requirement (PMR) for new drug application (NDA) holders of extended release/long-acting (ER/LA) opioids, to conduct a study to develop and validate a measure of the opioid-related adverse events misuse and abuse among patients with chronic pain prescribed long-term opioid therapy. This measure will be used to assess misuse and abuse in PMR Study 2065-1A and PMR Study 2065-4B.

Currently, no tool exists to meet this need except for the Self-report Misuse, Abuse and Diversion of Prescription (Rx) Opioids questionnaire (SR-MAD) which has undergone several rounds of prior content validation. The SR-MAD has been modified to meet the needs of PMR Studies 2065-1A and 2065-4B, and has been renamed the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ).

This study will seek to further develop and validate the POMAQ using the the Food and Drug Administration (FDA) Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (FDA 2009) as a reference for conducting qualitative research throughout the process of instrument development to ensure the content validity of a measure and to evaluate the comprehensibility of included questions. This qualitative study to evaluate content validity will be conducted prior to the quantitative study to evaluate construct validity

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Patients who, based on the Site Investigator's clinical judgment, have chronic moderate to severe pain
3. Willing to provide written informed consent
4. Able to participate in a one-on-one interview
5. Able to read, speak, and understand English and complete all study assessments.

Exclusion Criteria:

1. Cognitive, psychiatric or other impairment based on the Site Investigator's clinical judgment that would interfere with participating in a one-on-one discussion
2. Terminal illness with life expectancy \< 6 months.
Radiofrequency Ablation After Total Knee Arthroplasty

The purpose of this study is to assess how clinically useful and safe genicular nerve radiofrequency ablation is in people with chronic pain after total knee arthroplasty performed for osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

1. Eligible individuals over 18 years of age in general good health apart from their chronic knee pain
2. At least one year post-TKA
3. Report of chronic knee pain classified using a standard question about the presence of "pain, aching, or stiffness in the knee on most days for at least one month during the prior 6 months"
4. In an unacceptable symptom state classified using a validated question: "Think about all consequences of your arthroplasty in the last week. If you were to remain for the rest of your life as you were during the last week, would the current state be acceptable or unacceptable for you?"
5. Willingness to complete all the study procedures, including a daily pain NRS, AE, and medication usage questions via daily notification
6. Subjects must have read and understood the informed consent form (ICF), and must have signed and dated it prior to any study-related procedure being performed

Exclusion Criteria:

1. Pregnant women, breastfeeding women, and women who are not post-menopausal (defined at 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
2. Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control as outlined in Section 5.3.1 during the study period
3. Significant evidence of infection within the knee or radiographic evidence of prosthesis loosening as defined by the orthopedic surgeon
4. Individuals with pain exclusively located in the posterior knee, evaluated systematically using a validated Knee Pain Map
5. Individuals who do not achieve a 70% pain reduction following the initial prognostic block, consistent with clinical practice
6. Participation in a clinical research trial that included the receipt of an investigational product (IP) or any experimental therapeutic procedure within 30 days prior to the Screening Visit, or planned participation in any such trial
7. Use of anticoagulants and inability to withhold for three days prior to the study RFA procedure with clearance by the prescribing physician
8. Other conditions that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia

The purpose of this study is to compare the administration of a standard anesthetic drug (propofol) using an automatic, expert-based system versus a manually controlled system by the anesthesiologist. In addition, the performance of the decision support system will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing hip or knee replacement under spinal anesthesia

Exclusion Criteria:

* contraindication to spinal anesthesia
* allergies to any study drug
Effectiveness of Cervical Treatment in Wind Musicians With Temporomandibular Dysfunction

Temporomandibular dysfunction (TMD) consists of a series of multifactorial signs and symptoms that occur in the orofacial region, with pain being the most common symptom. There is a close biomechanical and anatomical relationship between the cervical region and the temporomandibular joint (TMJ) through the trigemino-spinal nucleus.

Objectives: To comparatively assess the improvement in subjects with TMD when adding cervical manual therapy to a postural treatment. Additionally, to determine if both cervical treatments separately produce changes in the TMJ.

Materials and methods: An experimental study of randomized controlled clinical trial type was conducted. The study involved 30 wind instrument players randomly assigned to an experimental group (EG) and a control group (CG). After obtaining consent, measurements were taken for maximum mouth opening (MMO), cervical range of motion, and pain threshold to pressure (PTP) in the masseter and temporalis muscles. Both groups underwent active cervical postural treatment for 4 weeks, and the EG additionally received a cervical manual therapy protocol. An initial assessment was conducted before the intervention, and a final assessment was done one week after the last intervention. The statistical program SPSS was used for data analysis.


Eligibility Criteria:
Inclusion Criteria:

* Acceptance of written informed consent.
* Playing a wind instrument.
* Age between 18-40 years.
* Pain in the cranio-cervico-mandibular region and/or masticatory muscles.
* Hypertrophy in the masticatory muscles.

Exclusion Criteria:

* History of trauma and/or fracture in the cranial and/or facial region.
* Rheumatic injury or degenerative disease.
* Surgical intervention on the temporomandibular joint (TMJ).
* Malformations of the cervical or cranial spine.
* Vestibular, circulatory, or neurological disorders.
* Degenerative or infectious joint diseases.
* Current orthodontic treatment.
* Receiving physiotherapy treatment during the two weeks prior to the study or during the study.
Analysis of Eye Tissue

The purpose of this investigation is to better understand the inflammatory process that occurs in uveitis (eye inflammation) through study of eye tissues.

Patients with uveitis sometimes develop cataracts (clouding of the lens of the eye) or clouding of the vitreous-the gel-like material behind the lens-that can impair eyesight. Those who require cataract surgery or vitrectomy are eligible for this study. Samples of eye tissue and fluid normally removed during standard surgical procedures for these conditions will be given to researchers instead of discarded, as is usually done.

Before surgery, patients will undergo routine preoperative tests, including chest X-ray, electrocardiogram, blood tests and urinalysis. They will also have an eye examination and photographs taken of the retina. Other tests that may be performed include fluorescein angiography to evaluate the blood vessels of the retina; ultrasound to examine the back of the eye; and a gallium scan to evaluate inflammation.

Immune cells in the blood and eye tissue will be compared and categorized by disease. The eye fluid will be examined for substances involved in the inflammatory process. These studies may provide information that will lead to improved methods of diagnosis and treatment.

The purpose of this project is to evaluate intra-ocular tissue such as iris or vitreous from uveitis patients in order to analyze the type and character of the inflammatory response. Patients with a history of uveitis who require cataract surgery or vitreous surgery because of the clinical complications of inflammation, will be entered in this study. The lymphocyte subsets in the peripheral blood and ocular tissue will be compared and categorized by disease. The presence of soluble lymphokines in the intra-ocular fluid will be analyzed. Long term cell cultures of vitreal cells will be attempted to define the T-cell receptors. In addition, a portion of iris tissue or vitreous cells will be frozen to establish a tissue library of uveitis.

Eligibility Criteria:
Patients of either sex will be admitted to this study.

All patients should have a previous history of uveitis.

The patient must have lenticular or vitreal opacities which are significantly impairing their vision and for which surgical removal of the opacity has a reasonable chance of improving the vision.

Patients should have vision of 20/80 or worse.

Patients may have any of the following syndromes: anterior uveitis, including HLA-B27-associated iritis and juvenile rheumatoid arthritis, ocular sarcoid, intermediate uveitis and pars planitis, birdshot retinochoroidopathy, Behcet's disease, Vogt-Koyanagi-Harada's syndrome, sympathic ophthalmia and idiopathic posterior uveitis.
Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure

The purpose of this study is to determine whether combined mortality and hospitalization in heart failure patients receiving optimal pharmacologic therapy can be reduced by combining optimal pharmacologic therapy and 1) biventricular pacing therapy alone or 2) biventricular pacing with defibrillation.

Evaluation of new therapies for the treatment of heart failure should address mortality, morbidity, hospitalization, and cardiac symptoms and function when compared to standard pharmacologic therapy. The COMPANION trial is designed to address all of these objectives. This clinical investigation is an open-label, prospective, multi-center, randomized clinical trial. Every patient enrolled in the study is to be prescribed to optimal pharmacologic heart failure therapy, as tolerated, regardless of randomization.

Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe heart failure, defined as symptomatic heart failure for at least six months with NYHA Class III or IV symptoms at the time of enrollment, AND at least one of the following events in the previous 12 months:
* Hospitalization for heart failure management
* Outpatient visit in which intravenous (IV) inotropes or vasoactive infusion were administered continuously for at least 4 hours
* Emergency room visit of at least twelve hours duration in which IV heart failure medications were administered (including diuretics)
* QRS \> or = 120 ms and PR interval \> 150 ms from any two leads of a 12-lead ECG
* Left ventricular ejection fraction \< or = 35%
* Left ventricular end diastolic dimension \> or = 60 mm (required only if LVEF measured by echo) or \> 3.0 cm/m2 \[The cm/m2 is calculated by LVEDD (in cm) divided by BSA (body surface area)\].
* Age \> or = 18 years
* Optimal pharmacologic therapy for heart failure

Exclusion Criteria:

* Unable or unwilling to undergo device implant and follow-up testing
* Meet the general indications for an implantable cardioverter defibrillator
* Meet the general indications for antibradycardia pacing
* Expected to receive a heart transplant in the next six months
* Chronic, medically refractory atrial tachyarrhythmias
* Unexplained syncope
* Myocardial infarction within 60 days of randomization
* History of non-compliance with oral heart failure therapy
* Progressive or unstable angina
* Uncontrolled blood pressure: Systolic BP \> 160 mm Hg or \< 85 mm Hg or diastolic BP \> 90 mm Hg
* Patients with a hypersensitivity to a 0.7 mg nominal dose of dexamethasone acetate
* Surgically uncorrected primary valvular heart disease
* Coronary artery disease (CAD) in which surgical or percutaneous correction is recent (within 60 days of randomization)
* Women who are pregnant or not using medically acceptable birth control
* Hypertrophic obstructive cardiomyopathy
* Amyloid disease
* Hospitalization for heart failure or IV inotropic or vasoactive therapy in excess of 4 hours in the 30 days prior to enrollment
* Have a tricuspid prosthesis
* Involved in any other investigational studies
* Life expectancy \< 6 months due to any other medical conditions
Effectiveness of Autologous Adipose-derived Stem Cells in the Treatment of Knee Cartilage Injury

This study was aimed to evaluate the efficacy and safety of Autologous Adipose-derived Mesenchymal Stem Cell Gel combine with High tibial osteotomy therapy in the treatment of cartilage damage in the knee. Investigator believe that this method will enable patients to recover better knee function and more repair of knee cartilage.

The patients who will underwent high tibial osteotomy were randomly divided into the experimental group and the control group. Abdominal fat extraction before operation in experimental group to prepare Adipose-derived Mesenchymal Stem Cell Gel, while the control group only underwent high tibial osteotomy. One month after operation, the experimental group was injected with Adipose-derived Mesenchymal Stem Cell Gel into the joint cavity, and the control group was injected with sodium hyaluronate in the joint cavity. Two groups of patients were followed up.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years, male and female, patient can tolerate surgery;
* Clinical diagnosis of degenerative arthritis by Radiographic Criteria;
* Obviously extra-articular malformation;
* Good contralateral interventricular cartilage;
* Course of disease ≥ six months;
* There was no obvious abnormality in tumor marker detection,or patient was evaluated has not at the risk of cancer;
* Subjects who understand and sign the consent form for this study.

Exclusion Criteria:

* Acute joint injury;
* Patients with severe primary diseases, such as cardiovascular,cerebrovascular, liver, kidney and hematopoietic system, and psychosis;
* Cancer patients;
* Women who are pregnant or breast feeding,or allergic constitution patient;
* Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-Hepatitis C virus -Ab), Hepatitis C (Anti-hepatitis C virus -Ab) and syphilis;
* Receive other open surgery related to knee operation within 6 months;
* Participation in another clinical trial;
* Failing to comply with the inclusion criteria, unwilling to comply with the research approach, or incomplete data affecting the curative effect or safety judgment.
Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)

The primary objectives of this study are to evaluate the immunogenicity and safety of concomitant administration of V419 (PR51) with 2 types of meningococcal serogroup C conjugate (MCC) vaccines to healthy infants at 3 and 4 months of age in terms of antibody seroprotection rate (SPR) to MCC. Participants also received a Haemophilus influenza type B (Hib)-MCC vaccination at 12 months of age. It was hypothesized that the SPR to MCC at 1 month post-dose 2 of either tetanus toxoid conjugated Meningo C (MCC-TT) or CRM197 conjugated Meningo C (MCC-CRM) vaccines would be acceptable when administered concomitantly with V419.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infant 46 to 74 days of age (both inclusive)
* Parent(s)/legal representative able to comply will the study procedures

Exclusion Criteria:

* Is participating in a study with an investigational compound or device since birth
* Has a history of congenital or acquired immunodeficiency
* Has a history of leukemia, lymphoma, malignant melanoma or myeloproliferative disorder
* Has a chronic illness that could interfere with study conduct or completion
* Has hypersensitivity to any of the vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or contraindication to any of the study vaccines
* Has a history, or mother has a history, of hepatitis B virus surface antigen (HBsAg) seropositivity
* Has a coagulation disorder that contraindicate intramuscular injection
* Has a history of vaccination with a hepatitis B, Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acellular or whole-cell), poliovirus, pneumococcal conjugate or polysaccharide, meningococcal serogroup C conjugate, measles, mumps, or rubella containing vaccine(s)
* Has a history of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, invasive pneumococcal, meningococcal serogroup C, measles, mumps or rubella infection
* Has received immune globulin, blood or blood-derived products, immunosuppressive agents systemic corticosteroids since birth
* Has received vaccination with an inactivated (except influenza vaccine) or conjugated or live vaccine in the last 30 days or vaccination with an inactivated influenza vaccine in the last 14 days
* Has received antipyretic, analgesic and non-steroidal anti-inflammatory medications in the last 48 hours
* Has a febrile illness or body temperature ≥38.0°C in the last 24 hours