cyrilzakka/clinical-trials huggingface dataset:
Endodontic Treatment of Primary Teeth Using Mineral Trioxide Aggregate Paste

The maintenance of primary teeth until their exfoliation has been one of the main purposes of Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of the permanent dentition. Often, injuries or extensive dental caries reach the pulp of deciduous teeth making maintenance on these dependent endodontic treatment arc. Thus, this study was to conduct a randomized clinical trial is to evaluate the performance of endodontic treatment in primary teeth using MTA paste, comparing to Vitapex.

After approval by the ethics committee of the patients Faculty of Dentistry, University of São Paulo that having root canal filling of primary teeth will be invited to participate in the study. A clinical examination and prior radiographic diagnosis will be-held. The patient will be randomized to one of two groups and will be made the endodontics by a dentist. The patient will be accompanied with periods of one week, one month and three months by a blinded evaluator. The outcome will be the success or failure of endodontic treatments evaluated through permanent tooth in the arch on clinical and radiographic conditions of normality. The longevity of the treatments will be evaluated by estimating survival rates by Kaplan-Meier. The differences between the survival rates according to the type of proposed endodontic treatment will be analyzed using the log-rank test with a minimum significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

* Primary teeth with pulp diagnosis and need endodontic treatment
* Patients whose guardians consent to their participation in the survey
* fistula or abscess
* bone rarefaction or visual diagnosis
* teeth in the remaining tooth structure and location of the injury rehabilitation permit do not have internal or external resorption involving more than one third of the root length
* have no bone loss in lateral root and disruption crypt and the presence of at least half of root

Exclusion Criteria:

* health problems systemic
* congenital facial deformities
* facial tumors
* syndromes
A Real-time Quality Control System of Magnetic-controlled Capsule Gastroscopy

With the rapid development of artificial intelligence technology, more and more deep learning technology has been applied to medicine. Our research is to develop a set of quality control system for magnetic capsule gastroscope using deep learning technology, and conduct a randomized controlled trial to verify its practical efficiency.

The accuracy of magnetic controlled capsule endoscopy(MCCE) in the diagnosis of stomach lesions is highly consistent with the traditional electronic gastroscopy. It has become a new comfortable and safe form for screening and It is also the beneficial complementarity of the traditional electronic gastroscope. To ensure the medical quality of magnetic controlled capsule endoscopy system, Based on Artificial Intelligence Deep Learning Technology ,investigators developed the Magnetic-controlled Capsule Endoscopic Assisted Quality Control System(AI-box).Randomized controlled trials will be conducted on prospective subjects to verify the quality control efficiency.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients aged 18-75 years old who underwent MCCG examination in Qilu Hospital of Shandong University, Shandong Provincial Hospital affilated to Shandong First Medican University, and the Binzhou Medical University Hospital.

Exclusion Criteria:

* People who are allergic to the ingredients prepared in the stomach before examination;
* Patients with astrointestinal bleeding or ulcers, or prior gastrointestinal bleeding or ulcers within the last 24 months;
* Patients with esophageal and gastric tumor diseases that are undergoing active surgical treatment;
* Contraindications to the MCE test, including suspected or known gastrointestinal obstruction, stenosis, fistula, diverticula, etc; presence of gastrointestinal obstruction symptoms such as pain or dysphagia;
* Prior gastrointestinal tract or abdominal surgery other than simple procedures which would not change the gastrointestinal tract anatomy, such as polyp removal, cholecystectomy or appendectomy;
* Inoperative conditions or refusal to undergo abdominal surgery if required (ie, if the capsule will not pass and cannot be removed by endoscopy);
* A cardiac pacemaker is installed in the body, except when the pacemaker is a new MRE-compatible product;
* Electronic devices such as cochlear implant, magnetic metal drug infusion pump, nerve stimulator and magnetic metal foreign body are implanted in vivo;
* Planned MRI examination before capsule endoscopy discharge;
* Pregnant women;
* Patients with deglutition disorders or gastric emptizing disorders.
Long-Term Follow-Up of Patients Who Received Gene-Modified Cell Therapy

Observational long-term follow-up study of patients who have been exposed to a gene-modified cell therapy produced by ex vivo transduction of immune cells expressing viral or non-viral vectors in studies sponsored by Sorrento Therapeutics, Inc.

Study CGT-LTFU-35 is an observational study of patients who have been exposed to a gene-modified cell therapy (GMCT) produced by ex vivo transduction of immune cells expressing viral and/or non-viral vectors in studies sponsored by Sorrento Therapeutics, Inc. Patients are to be followed for up to 15 years after exposure to a GMCT agent for the possible development of long-term adverse events and efficacy outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have received any amount of a CGT in a study sponsored by Sorrento Therapeutics, Inc.

Exclusion Criteria:

* Unable or unwilling to provide written informed consent and/or comply with study requirements.
Use of Standardized Diagnostic Imaging Data for Image Fusion in the Hybrid Operating Room

Objectives:

Goal of the study is to investigate the potential benefit that transcatheter interventions such as Transcatheter Aortic Valve Implantation (TAVI), MitraClip, Left Atrial Appendage Closure and catheter Ablation can gain from multimodal image fusion techniques as they are available in the Hybrid suite.

Both the HeartNavigator and the EchoNav aim at decreasing the exposure to radiation and contrast agent, to shorten the operation time (efficacy), and to increase the quality of care (safety).

This pilot study aims at observing these aims on a small patient population and a control group.

Number of Subjects:

140 patients total in 6 groups:

* MitraClip, Left Atrial Appendage Closure or catheter Ablation with EchoNav (20, lead-in stage).
* MitraClip randomized with EchoNav (25), MitraClip randomized without EchoNav (25).
* TAVI with HeartNavigator lead in (10)
* TAVI randomized with HeartNavigator (30), TAVI randomized without HeartNavigator (30).

Medical Device:

HeartNavigator: System for preoperative image-based assessment of aortic root geometry, planning of transcatheter aortic valve implantation, and intraoperative C-Arm control.

EchoNav: System for intraoperative registration of 3D Echo images with X-ray fluoroscopy images.

Eligibility Criteria:
Inclusion criteria:

* Male and female patients over 18 years of age.
* Ability and willingness to give informed consent.
* Indication for TAVI, MitraClip, catheter ablation or percutaneous closure of the left atrial appendage procedure performed in the hybrid OR suite.
* Recent good quality CTA (TAVI patients only, no CTA needed for EchoNav).

Exclusion criteria:

* Contraindications on ethical grounds,
* Women who are pregnant or breast feeding,
* Emergency cases,
* Contraindication or known hypersensitivity to contrast media which is unresponsive to pretreatment with steroids and antihistamines,
* Known renal insufficiency (GFR \< 50 ml/min) and patient is not on chronic hemodialysis (TAVI patients only, no contrast agent is necessary during MitraClip and transseptal puncture),
* Contraindications for transesophageal Echo (EchoNav patients only, TAVI is possible without TEE and TEE is not needed for the HeartNavigator),
* Known or suspected drug or alcohol abuse,
* Enrollment into a clinical trial within last 4 weeks if overlapping enrolment is not explicitly approved by ethics committee for the two trials,
* Patient is unable or unwilling to cooperate with the study protocol.
Phthalates Exposure in Type 2 Diabetic Patients and Diuretic Therapy

In this open clinical trial, 30 subjects with inadequately controlled T2D and eligible, as per good clinical practice, for therapy with SGLT-2 inhibitor, will be randomized to receive a SGLT-2 inhibitor vs other oral-antidiabetic drugs (OADs) therapy for 3 months. Measures will be performed at baseline, after 2 days, after one month and at the end of the study protocol, as per good clinical practice

* Total concentrations of MEHP, MEOHP and MEHHP will be quantified, in the laboratories of the Institute of Clinical Physiology, National Research Council, Pisa, in a spot morning urine sample by ultra-HPLC coupled with electrospray ionization/quadrupole time-of-flight mass spectrometry (Agilent UHPLC 1290 infinity coupled to an Agilent 6540 MS-QTOF, Santa Clara, CA) using stable isotope labeled substrates, i.e. MEHP (ring-1,2-13C2, dicarboxyl-13C2), MEHHP, MEHHP 13C4, MEOHP and MEOHP 13C4 that will be purchased from Cambridge Isotope Laboratories (Tewksbury, MA).
* Urinary creatinine concentrations will be measured to adjust urinary concentrations of DEHP metabolite (Beckman Coulter AU400, Brea, CA), thus minimizing the inﬂuence of urine volume.
* Serum and urinary inflammatory markers and adipocytokines will be quantitatively determined using sandwich enzyme-linked immunosorbent assays kits according to the manufacturer's instructions. Optical density will be measured using a microplate reader.
* Serum and urinary markers of oxidative stress will be measured by gold standard techniques. In detail, MDA will be quantified by TBARS reactive substances measured by optical density; GSH-Px by a specific assay kit according to the manufacturer's instruction; SOD activity will be determined using a specific SOD kit; urinary 8-isoprostane concentration will be measured by a specific affinity sorbent. (Cayman Chemical, Ann Harbor, MI, USA) according to the manufacturer's instructions.
* To analyze mitochondrial DNA we will apply a triplex design previously reported to amplify mitochondria loci located within the MinorArc and MajorArc, respectively. To assess nuclear DNA, we will use RNase P Copy Number Reference.
* The phthalates-free diet will be self-administered by the individuals under intervention, following a set of instruction and rules provided by the physicians based on the current literature data.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of both sex;
* Age between 18 and 85 years;
* T2D
* T2D duration \> 6 months
* BMI ≤ 40 Kg/m2,
* HbA1c \> 48 mmol/mol
* Eligible for SGLT-2i therapy

Exclusion criteria

* age \>85 years,
* eGFR \<60 ml/min/1.73 m2,
* occurring acute complications
Psychological Intervention modifiEs Outcome of Patients With implAntable Cardioverter dEfibrillator: The PEACE Study

This study aims to investigate whether follow-up with a psychologist has an impact on the outcome of patients with an implantable automated defibrillator.

The implantation of an ICD in primary prevention is known to increase the rates of anxiety and depression, which can reach up to 45% and 35% respectively in this patient population. Several studies have reported that psychological accompaniment for these patients can alleviate the symptoms of anxiety and/or depression. Therefore, we aim to investigate the utility of psychological follow-up for a period of 1 year after first implantation of an ICD for primary prevention.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (aged 18 years or over)
* indication for implantation of an ICD for primary prophylaxis
* written informed consent provided
* patients with social security coverage

Exclusion Criteria:

* patients under legal tutorship or guardianship
* patients with no social security coverage
* patients still within the exclusion period after participation in another clinical trial, as indicated by the national registry of clinical trial volunteers
* patients unable to complete the questionnaires (language barriers, mentally deficient, illiteracy or dementia)
* patients awaiting heart transplant
* patients who refuse to provide written informed consent
Effect of Concomitant Bladder Neck Incision and Urethral Valve Ablation on Surgical Re-intervention Rate for Patients With Posterior Urethral Valve

To determine the short-term effects of concurrent valve ablation and bladder neck incision on re-intervention rate for patients with posterior urethral valve.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are less than 12 years of age with presenting to the Mansoura University Urology and Nephrology Center with the diagnosis of PUV will be s creended for eligibility

Exclusion Criteria:

* Patients with other conditions that can potentially affect lower and upper urinary tract functions
* Patients who were treated with urinary diversion as vesicostomy or cutaneous ureterostomy.
* Patients who had primary treatment of posterior urethral valve ablation at other hospitals.
Blue Light Cystoscopy With Cysview® Registry

Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.

Data will be captured on specific patient types undergoing Blue Light Cystoscopy with Cysview for known or suspected non-muscle invasive bladder cancer. Specific clinical questions will be asked.

1. What is the incremental detection rate with Blue Light Cystoscopy with Cysview over conventional white light cystoscopy in each of the seven (7) patient populations? Does this translate into lower recurrence/progression rate?
2. How do the six (6) tumor variables used in the European Association of Urology (EAU) risk tables (primary/secondary, recurrence rate, size, multifocality, grade, and history of carcinoma in situ (CIS))6 affect this incremental rate?
3. How does an abnormal cytology or positive or negative fluorescent in situ hybridization (FISH) affect the likelihood that Blue Light Cystoscopy with Cysview will detect more cancers than white light?
4. What are the performance characteristics of Blue Light Cystoscopy with Cysview within eight (8) weeks of Bacillus Calmette-Guérin (BCG) with respect to improved tumor detection and false positive rate compared to conventional white light cystoscopy?
5. What is the incremental Blue Light Cystoscopy with Cysview detection rate over random bladder biopsies alone in patients being evaluated for routine three month restaging (group 4) or occult disease (group 5)?
6. What are the performance characteristics of Blue Light Cystoscopy with Cysview after repeated Blue Light Cystoscopy with Cysview evaluations with respect to improved tumor detection, false positive rate and safety compared to conventional white light?
7. Does an abnormal urinalysis help identify patients with inflammation more likely to have false positive Blue Light Cystoscopy with Cysview results?
8. What is the practical learning curve for becoming "proficient" with Blue Light Cystoscopy with Cysview?
9. What is the overall false positive rate with Blue Light Cystoscopy with Cysview?
10. Can Blue Light Cystoscopy with Cysview make the resection more complete? If yes, is this due to improved margins and/or additional tumors seen under blue light?

The Blue Light Cystoscopy with Cysview Registry is a web-based program supported by Global Vision Technologies. Data will be captured longitudinally over five (5) years on patients from each enrolled site. Each center will enter their respective site's patient data electronically.

Eligibility Criteria:
Inclusion Criteria:

* Adult \>18 years old
* Suspected or known non-muscle invasive bladder cancer on the basis of a prior cystoscopy

Exclusion Criteria:

* Porphyria
* Gross hematuria
* Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives
Singe Dose Study of PF- 06946860 in Healthy Adult Japanese Participants

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06946860 in healthy adult Japanese participants following single dose administration.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
* Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb)
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
* Subjects enrolling as Japanese must have four biologically Japanese grandparents born in Japan.

Key Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
* History of allergic reactions to diagnostic or therapeutic protein or human albumin.
* History of recurrent infections or active infection within 28 days of screening.
* Exposure to live vaccines within 28 days of screening.
* History of regular alcohol consumption or positive drug test
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of IP (whichever is longer).
* Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after the last dose.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose
Timing of Serial Ultrasounds

The purpose of this randomized controlled trial is to compare the frequency of the diagnosis of fetal growth abnormalities when ultrasound assessment is performed at 2 versus 4 week intervals.

While there is an agreement that women at risk for abnormalities of fetal growth should have serial ultrasound examinations in the 3rd trimester, there is a lack of consensus on how frequently these exams should be done. The American College of Obstetrics and Gynecology recommend that an ultrasound to assess fetal growth be performed between 2 to 4 weeks; however, there have been no prospective or randomized trials to determine whether the optimal interval should be closer to 2 weeks or delayed to 4 weeks. Currently, only 60% of fetuses' with abnormal growth are detected antenatally. There is equipoise of whether ultrasound every 2 versus 4 weeks improves the detection and subsequent newborn outcomes or merely leads to an increase in false positives and unnecessary interventions. It has been proposed, that if delivery occurs within 2 weeks of the ultrasound, the antenatal detection of abnormal growth may be more accurate and hence more likely to improve outcomes. Conversely, a shorter interval may result in confusion as to whether there is actual change in growth or merely variation in the measurement technique itself. Moreover, with the cost of ultrasound averaging approximately $200 per examination, the interval between ultrasounds can have major implications on public-health costs as well as the interventions that subsequently follow if an abnormality is detected.

The purpose of this randomized controlled trial is to compare the frequency of the diagnosis of fetal growth abnormalities when ultrasound assessment is performed at 2 versus 4 week intervals.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age ≥ 18 years
* Singletons
* Gestational age ≥ 20 weeks to 27 weeks 6 days
* Has insurance, whether private or government issued
* High-risk pregnancy requiring serial fetal growth assessment as determined by the treating physician.
* Dating of pregnancy by ultrasound ≤ 21 weeks and 6 days of gestation or known date of conception in the setting of in vitro fertilization
* No known major anomalies

Exclusion Criteria:

* Known major fetal anomaly
* Multiple gestation (twins or triplets)
Pain, Inflammation and Opioid Craving

The goal of this study is to investigate the association between response to pain and opioid craving in people with opioid use disorder. In this study, adults with opioid use disorder will be randomized to one of two brief education sessions followed by an assessment of response to pain. Investigators will test the association between response to pain and opioid craving.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older;
* diagnosis of opioid use disorder
* chronic pain
* ability to read and provide informed consent

Exclusion Criteria:

* major psychiatric or medical condition that would interfere with participation
* current opioid withdrawal
* currently receiving opioid analgesic medication for pain
* recent history of myocardial infarction or other serious cardiovascular condition
* current peripheral neuropathy, active vasculitis or severe peripheral vascular disease
* systematic inflammatory or autoimmune disorder
* admitted to current treatment episode on an involuntary status
A Study of MK-4827 in Combination With Standard Chemotherapy in Participants With Advanced Solid Tumors (MK-4827-008 AM1)

This study will find the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of MK4827 when administered in combination with standard doses of carboplatin, or carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin in the treatment of advanced solid cancers in adults.

The decision to discontinue new enrollment is not related to any concerns about the safety profile of the product.

Eligibility Criteria:
Inclusion Criteria:

* Participant has a locally advanced or metastatic solid tumor for which carboplatin, carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin are the standard of care.
* Participant has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.

Exclusion Criteria:

* Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to entering the study.
* Participant has had more than two prior lines of chemotherapy.
* Participant has known central nervous system metastases or a primary central nervous system tumor.
* Participant is pregnant or breastfeeding or expecting to conceive during the timeframe of the study.
* Participant is known to be human immunodeficiency virus (HIV) positive.
* Participant has a history of Hepatitis B or C.
* Participant has a symptomatic pleural effusion.
* Participant with a left ventricular ejection fraction (LVEF) below the institutional norm, or with prior exposure to doxorubicin is not eligible for the MK4827 + carboplatin/liposomal doxorubicin study arm.