cyrilzakka/clinical-trials huggingface dataset:
Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study

The purpose of this study is to evaluate the safety and feasibility of the Bio Refine Coriofix System and determine if it might help in treatment of functional mitral regurgitation.

The study will include patients with symptomatic secondary mitral regurgitation in whom mitral surgery cannot and/or will not be offered as a treatment option (the risk is prohibitive).

Potential patients will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure.

All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge.

Additional follow up time points are scheduled at 30 days, 6 months and 12 months post procedure.


Eligibility Criteria:
Inclusion Criteria:

* Local heart team has determined that mitral valve surgery will not be offered as a treatment option
* Symptomatic secondary mitral regurgitation (3+ or 4+)
* Adequately treated in compliance with optimal guideline-directed medical therapy for heart failure for at least 90 days
* NYHA functional class II, III or ambulatory IV
* LVEF ≥30%.
* Written informed consent has been obtained

Exclusion Criteria:

* Untreated clinically significant coronary artery disease requiring revascularization.
* CABG, PCI or TAVR within the prior 90 days.
* Aortic or tricuspid valve disease requiring surgery or transcatheter intervention or severe tricuspid regurgitation.
* COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use.
* CVA or TIA within prior 180 days.
* Hypotension
* Any history of ventricular arrythmia
* Patients implanted with any kind of CIED
* Life expectancy \<12 months due to non-cardiac conditions
* Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure
* TEE is contraindicated or high risk
* Pregnant or planning pregnancy within next 12 months
* Currently participating in an investigational drug or another device study that has not reached its primary endpoint
Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in NAFLD

This is a randomised clinical trial which aims to evaluate the efficacy of Compound Zhenzhu Tiaozhi capsules in the treatment of NAFLD and analyze the relationship between improvement in NAFLD parameters and changes in intestinal functions.

This is a randomised clinical trial which aims to evaluate the efficacy of Compound Zhenzhu Tiaozhi capsules in the treatment of NAFLD and analyze the relationship between improvement in NAFLD parameters and changes in intestinal functions. In this study, the investigators will (1)evaluate the relationship between the function of intestinal mucosal barrier, SIBO, and NAFLD;(2)assess the effects of Compound Zhenzhu Tiaozhi capsules on intrahepatic fat content, hepatic noninvasive score, liver biochemical parameters, blood lipid, and insulin resistance. To evaluate the therapeutic effects of Compound Zhenzhu Tiaozhi capsules on the treatment of NAFLD, and determine whether the risk stratification of atherosclerotic cardiovascular disease (ASCVD) and quality of life (using the 36-Item Short Form Health Survey \[SF-36\]) can be improved in NAFLD patients with Compound Zhenzhu Tiaozhi capsules;(3) compare the therapeutic effects of Compound Zhenzhu Tiaozhi capsules with conventional medications in the treatment of NAFLD, and to compare their efficacies in improving the risk stratification of ASCVD and quality of life, as assessed by the SF-36; (4) analyze the relationship of Compound Zhenzhu Tiaozhi capsules in improving NAFLD and parameters related to the function of the intestinal mucosal barrier and SIBO.

Eligibility Criteria:
Inclusion Criteria:

clinical diagnosis of simple steatosis or NASH 18 to 75 years old serum alanine transaminase (ALT)≤2 times the upper limit of normal

Exclusion Criteria:

other chronic liver diseases serious complications in other organs malignant tumors
A Cohort Study of Congenital Cytomegalovirus Infection Among Pregnant Women and Their Newborns in China

The purpose of this study is to assess the risk of congenital cytomegalovirus (cCMV) infection in newborns born to seropositive women.

This study will be conducted at several Maternal and Child Health Hospitals (MCHHs) in China and the research activities will be integrated with routine medical services during pregnancy at the study sites.The investigators will build a perspective cohort study enrolling \~8000 pregnant women elder than 18 and following up their newborns at specific MCHHs.As a first step, The investigators will work with these hospitals to recruit the subjects. After being informed, the participants' remaining blood and urine samples (after their medical examinations) at their early, medium and late stages of pregnancy will be collected , and their newborns' urine and saliva samples will be collected after delivery. The aim of this study is to enroll 5000 series mother-newborns.

Eligibility Criteria:
Inclusion Criteria:

* Females aged 18 and older
* Pregnancy confirmed by ultrasound
* Come to MCHHs for "Pregnancy Registry" within 24 weeks of pregnancy

Exclusion Criteria:

* Not capable of complying with study procedures, or having a psychosis, two-stage affective psychosis, or have a tendency to suicide
* Having any autoimmune diseases (include systemic lupus erythematosus, rheumatoid arthritis), immunodeficiency (e.g. AIDS), chronic disease history such as cancers
A Telephone-delievered Intervention to Reduce Methamphetamine Use

Australia has one of the highest rates of methamphetamine use in the world; however, uptake of face-to-face psychological treatment remains extremely low due to numerous individual (e.g. stigma, shame) and structural (e.g. service availability, geography) barriers to accessing care. Addressing these barriers through the provision of alternative treatment delivery models is imperative, particularly as effective and earlier intervention is likely to reduce the need for more costly and intensive treatment resulting from escalating methamphetamine use.

In this project, the investigators will conduct the first double-blind, parallel-group, randomised controlled trial (RCT) examining the effectiveness of the structured telephone-delivered intervention, Ready2Change (R2C), among participants with methamphetamine use problems (R2C-M). Cost effectiveness of R2C-M will also be investigated. Factors influencing program implementation will be evaluated to inform the scalability of this intervention for practice nationally, and for replication internationally.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+ years
* Mild or moderate methamphetamine use disorder (DSM-5 diagnosis confirmed at baseline assessment using the Structured Clinical Interview for DSM-5 Disorders - Research Version, SCID-5-RV)
* Used methamphetamine on at least two occasions in the past month
* Seeking to reduce methamphetamine use
* Able to provide informed consent, and comply with the requirements of the treatment protocol
* Willing to provide the contact details of their general practitioner or other treating physician, for follow-up
* English as a first language or fluent
* Educated to high school level (literacy)
* Regular access to a telephone
* Postal/email address to receive intervention materials

Exclusion Criteria:

* Currently receiving treatment for substance use disorder (e.g. medically supervised detoxification, residential rehabilitation, drug counselling, pharmacotherapy - this criterion applies only at trial enrolment, and does not preclude the participant from entering treatment/receiving usual care during the trial)
* Requiring acute care for severe substance use disorder (DSM-5 diagnosis confirmed at baseline using the SCID-5-RV, with oversight from the Principal Investigator or Study Clinician)
* Requiring acute care for active suicidality or unstable psychiatric condition
* A diagnosed primary psychotic disorder (schizophrenia, schizoaffective disorder, bipolar disorder)
* Pregnancy
* Hearing impairment that would prohibit participation in telephone intervention / follow-up assessments
Contrast-Enhanced Ultrasonography in Diagnosing Early-Stage Ovarian Cancer in Patients With an Adnexal Mass Undergoing Surgery to Remove the Ovary

RATIONALE: New diagnostic procedures, such as contrast-enhanced ultrasonography, may be an effective method of finding ovarian cancer.

PURPOSE: This clinical trial is studying how well contrast-enhanced ultrasonography works in diagnosing early-stage ovarian cancer in patients with an adnexal mass undergoing surgery to remove the ovary.

OBJECTIVES:

* Determine whether use of a contrast agent improves the images of the ovaries during ultrasonography.

OUTLINE: This is a multicenter study.

Patients may undergo baseline transabdominal or transvaginal ultrasonography, if not already done. Patients then undergo contrast-enhanced transabdominal or transvaginal ultrasonography using perflutren lipid microspheres (Definity®) IV.

Pathology reports from tissue collected during subsequent oophorectomy is analyzed and compared with ultrasonography findings.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of adnexal mass
* Scheduled to undergo surgical oophorectomy

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* Negative pregnancy test
* No known respiratory failure as manifested by signs and symptoms of carbon dioxide retention or hypoxemia
* No pulmonary vasculitis
* No known history of severe emphysema
* No known history of pulmonary emboli
* No other condition that causes pulmonary hypertension due to compromised pulmonary arterial vasculature
* No known history of severe pulmonary hypertension (i.e., systolic pulmonary artery pressures \> 90 mm Hg)
* No known history of congenital heart defect that creates a bidirectional or right-to-left shunt
* No worsening or clinically unstable congestive heart failure
* No known acute myocardial infarction or acute coronary syndromes
* No known serious ventricular arrhythmias
* Not at high risk for arrhythmia due to prolongation of the QT interval
* No known or suspected hypersensitivity to blood, blood products, or albumin
* No known hypersensitivity to perflutren
* No known or suspected hypersensitivity to octafluoropropane or any other ingredients of perflutren lipid microspheres (Definity®)
* No mental status problems, illiteracy, or other circumstance that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
An Evaluation of Tailored Messages to Address Parental Questions About HPV Vaccination

The purpose of this study is to investigate mother's attitudes about vaccinating their 11-14 year old children against the human papillomavirus (HPV). Among mothers who do not plan to vaccinate their child, the investigators will assess the influence of brief videos tailored to mothers' questions and concerns. Mothers will be randomized to one of three arms: 1. General video message about vaccination; 2. General message plus a brief video addressing the mother's primary concern; or 3. General message plus videos address all of mother-indicated concerns. The outcome of interest is intention to vaccinate. Our hypothesis is that the tailored videos will lead to increased intention to vaccinate.

Attitudes will be assessed through a Web-based survey administered by Survey Sampling International (SSI). The projected sample size is approximately 3,500, comprising mothers or female guardians of at least one child aged 11-14 who live in the United States. The survey will take no more than 20 minutes to complete. Mothers who indicate that they do not plan to vaccinate their children in the next year will be randomized to view brief videos tailored to their questions or concerns about HPV vaccination. The outcome of interest is intention to vaccinate. Mothers who have vaccinated their child or intend to vaccinate their child will be asked a separate set of questions relevant to this information.

Mothers who indicate that they do not intend to vaccinate their child against HPV will be asked about their questions or concerns regarding HPV vaccination (from a pre-populated list of common concerns). Mothers will be randomized to one of three arms: 1. A general information video; 2. The general video plus a video addressing their top concern; or 3. The general video plus one or more videos addressing all of their concerns. Each video is less than 50 seconds in length.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Lives in one of 26 US states with lower rates of HPV vaccination (New Jersey, Virginia, West Virginia, Alabama, Florida, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee, Indiana, Minnesota, Ohio, Arkansas, Louisiana, New Mexico, Oklahoma, Kansas, Missouri, Montana, South Dakota, Utah, Wyoming, Idaho, Texas, Iowa)
* Mother or female legal guardian of at least one child aged 11-14 years
* Able to read and understand English
* Target child must not have received any doses of HPV vaccine
* The mother/respondent must indicate that she is not sure that she will vaccinate the target child in the next year.

Exclusion Criteria:

* Under 18 years of age
* Not a mother or female legal guardian of at least one child ages 11-14 years
* Not living in the United States or in one of the above designated states within the U.S.
* Not able to understand or read English
* Target child has already received at least 1 dose of HPV vaccine
* The mother/respondent indicates (before the intervention) that she definitely intends to vaccinate the target child with HPV vaccine in the next year.
Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils

The primary objective of this study is to determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent is obtained.
* The participant is male or female, 12 years of age and older, with a diagnosis of asthma.
* The participant has Forced Expiratory Volume in 1 Second (FEV1) reversibility according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol.
* The participant has required an inhaled corticosteroid.
* The participant has required an additional asthma controller medication besides inhaled corticosteroids.
* The participant has a history of asthma exacerbation.
* The participant must be willing and able to comply with study restrictions, perform requisite procedures and remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol.

  * Additional criteria may apply, please contact the investigator for more information

Exclusion Criteria:

* The participant has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patient's safety.
* The participant has another confounding underlying lung disorder
* The participant has a known hypereosinophilic syndrome.
* The participant has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
* The participant is a pregnant or lactating woman, or intends to become pregnant during the study. Any woman becoming pregnant during the study will be withdrawn from the study.
* The participant is a current smoker or has a smoking history.
* The participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
* The participant was previously exposed to reslizumab.
* The participant has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).
* The participant has current or suspected drug and alcohol abuse.
* The participant has an active helminthic parasitic infection or was treated for one within 6 months of screening.
* The participant has a history of allergic reaction or hypersensitivity to any component of the study drug.

  * Additional criteria may apply, please contact the investigator for more information
Safety and Efficacy of PegIntron Plus Rebetol in Patients With Chronic Hepatitis C in Japan, Excluding (1) Subjects With HCV Genotype 1 and High Viral Load, and (2) Interferon-naïve Subjects With Low Viral Load (Study P04841)(COMPLETED)

The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C. The study will exclude (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with chronic hepatitis C
* Among interferon-naïve patients, only patients with high viral load and HCV genotype other than 1
* Among prior nonresponders or relapsers to interferon monotherapy, (1) patients with high viral load and HCV genotype other than 1; and (2) patients with low viral load of all genotypes (including genotype 1)

Exclusion Criteria:

* Patients infected with HCV genotype 1 with high viral load, regardless of whether treatment-naïve or previous nonresponders/relapsers
* Interferon-naïve patients with low viral load
* Patients with a history of hypersensitivity to test drugs or other interferon preparations
* Patients with a history of hypersensitivity to biological products, such as vaccines
* Patients being treated with Shosaikoto
* Patients with autoimmune hepatitis
* Pregnant women, women who may be pregnant, and nursing mothers
* Patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.)
* Patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia)
* Patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia)
* Patients with chronic renal failure or renal function disorder with creatinine clearance of \<=50 mL/min
* Patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt
* Patients with serious hepatic dysfunction
* Patients with autoimmune hepatitis
3Mixtatin and MTA Vital Pulpotomy in Primary Molars

The aim of the study is to evaluate clinical and radiographic success of using 3Mixtain versus mineral trioxide aggregate in pulpotomy of deeply carious Primary molars.

Due to the complexity of the root canal microbiome, it is doubtful that they can be treated properly with a single antibiotic. Accordingly, a combination of multiple antibiotics seemed to be essential to diminish different types of pathogenic bacteria. Recently, a combination of three antibiotics (Metronidazole, cefixime, and Ciprofloxacin) along with Statins (new bio-inductive materials in regenerative dentistry) has shown promising results in primary teeth pulp therapy.

Statin components have an anti-inflammatory impact on pulp tissue by lowering the amount of interleukin-6 and interleukin-8. They also decrease osteoclastic processes and strengthen osteoblastic processes. Thus, they promote bone regeneration and dentin formation by enhancing odontoblastic activity. Several studies have shown a clinical and radiographic success rate of 3Mixtatin with inconsistent results. Some randomized controlled Trials (RCTs) showed that MTA had a comparable result with 3Mixtatin, while others reported that 3Mixtatin might be an alternative for MTA due to its higher overall success rate. 3Mixtatin is considered as a novel material with successful outcomes. Owing to limited availability of data in researches and in order to reach a conclusive results our study aims to evaluate clinical and radiographic success of using 3Mixtain versus mineral trioxide aggregate in pulpotomy of deeply carious Primary molars .

Eligibility Criteria:
Inclusion Criteria:

* • Children 4-8 years old

  * Vital deeply carious primary molars.
  * No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of the vestibule.
  * Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.
  * Patient and parent showing cooperation and compliance.

Exclusion Criteria:

* • Uncooperative children to avoid time waste and attrition bias.

  * Unrestorable molars
  * Sign of radiolucency in periapical or furcation area
  * Widening of PDL space or loss of lamina dura continuity
  * Evidence of internal/external pathologic root resorption
  * During operative procedure, when hemorrhage control is not achievable after pulpotomy.
  * Children with systemic disease as some systemic diseases may have effect on the outcome.
  * Unable to attend follow-up visits to avoid attrition bias by decreasing number of drop off cases.
  * Refusal of participation as the parent of child has the authority of participation.
Intraocular Pressure Control Following One Site Versus Two Site Combined Phacoemulsification/IOL And Trabeculectomy

The purpose of this study is to compare the safety \& effectiveness of the two types of cataract and glaucoma surgeries. Results from this study may improve the surgical and post surgical management and long term management of patients with these conditions in the future

The purpose of this study is to determine whether a Two-Site Technique for the Combined Procedure for subjects with coexisting visually significant glaucoma \& cataracts will result in an improvement in IOP control in both the immediate and longer term postoperative period as compared with the currently Standard One Site surgical technique for both glaucoma and cataracts.

Research and data indicate that the success rate of the glaucoma part of this operation may be improved if the incision for the cataract part of the operation is separated from the drainage hole created for the glaucoma part, the constant drainage through this hole is what lowers the intraocular pressure after surgery. Using the Two-Site Combined procedure the glaucoma incision(drainage hole) will still be created superiorly, under the upper lid. The cataract incision will be moved to the temporal side of the eye ball, away from the drainage hole for the glaucoma.

Eligibility Criteria:
Inclusion Criteria:

* Meet the current criteria for combined procedure surgery:
* A visually significant cataract(ie: an opacification of the crystalline lens resulting in a reduction of visual performance affecting daily living
* Open angle or mixed mechanism glaucoma inadequately controlled on current therapy, or requiring two or more medications for control, or with advanced visual field and optic nerve damage.

Exclusion Criteria:

* Subjects with normal tension glaucoma(defined as those subjects in whom no IOPs greater than 21 mm Hg\[preceding or during therapy\]have been recorded)
* Subjects with uveitis
* Subjects with neovascular glaucoma
* Severe conjunctival inflammation or scarring
* Subjects who have had previous incisional ocular surgery in the same eye
* No subjects will have second eye operated on within 8 weeks of the first eye