cyrilzakka/clinical-trials huggingface dataset:
Urethral Stricture: A Comparison Between Jugal or Labial Graft Urethroplasty

Buccal mucosa urethroplasty is a current fashion in urethral stricture management. In our university centre (Hospital de Clínicas de Porto Alegre) is a common surgical treatment choice. This paper aims to evaluate the success rate of this treatment after randomized choice between labial and jugal (inner cheek) grafts during the past two years.

Free dorsal graft urethroplasty, first described by Barbagli et al, has been shown better results than ventral grafts. Fixed grafts on the corpora cavernosa results in a better mechanical support and vascular supply, with less chance to complications such as pseudodiverticula and sacculations either a better urethral phisiology.

This study aims to evaluate the current surgical management in our centre: buccal mucosa graft urethroplasty with jugal or labial replacement, comparing their group success rate and complications between the groups in patients led to surgery from October 2016 to June 2018.

Prospective analysis from urethral stricture surgical HCPA patient data by dorsal buccal mucosa graft urethroplasty. The graft choice were done by a software. Longer stricture with transoperative need for the two grafts use were excluded. Success rate were measured with a no stricture de novo or absence of complications in a six month interval.

Eligibility Criteria:
Inclusion Criteria:

* Urethral Stricture Diagnosis
* Indication for buccal mucosa graft urethroplasty
* Accept the Informed Consent Term (patient or responsible)

Exclusion Criteria:

* Severe urethral stricture which a two-staged procedure are required
* Long strictures which need a both types of buccal mucosa graft due its length.
* Refuse to ICT for the patient ou it responsible
Efficiency and Outcomes of Stress-Only Anger and D-SPECT Stress-Only SPECT MPI

The purpose of this study is to compare clinical efficiency and patient outcomes using ultra low-dose stress only Tc-99m and solid-state SPECT versus traditional Anger SPECT.


Eligibility Criteria:
Inclusion Criteria:

* BMI \< 35 kg/m2
* LVEF \> 40%
* Exercise stress
* Elective out-patients
* No known CAD (\>50%) by catheterization
* No history of prior myocardial infarction

Exclusion Criteria:

* LBBB
* Pacemaker
* Atrial Fibrillation
* Frequent PAC's or PVC's
* Inability to achieve at least 6 minutes
Patient-Reported Outcomes for Lemborexant in Chinese Participants With Insomnia

This study is a prospective, open-label, single arm, multicenter study lasting 12 weeks to evaluate effectiveness and safety of lemborexant(LEM). Patient self-evaluation reports and safety events will be collected at baseline and 4 visits during treatment.

This study is a prospective, open-label, single arm, multicenter study lasting 12 weeks to evaluate effectiveness and safety of lemborexant(LEM). Adult patients diagnosed with insomnia (including chronic and short-term insomnia) in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and ISI ≥10, clinically judged to need pharmacological treatment will be enrolled.Patients will be administered with LEM, and patient self-evaluation reports and safety events will be collected at baseline and each visit during treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years) and agreed to participate in the study, regardless of gender.
* Diagnosed with insomnia according to DSM-5.
* Insomnia Severity Index (ISI) score \>10.
* Subjects who can guarantee at least 7 hours of bedtime.
* Subjects signed informed consent forms after the prescription.

Exclusion Criteria:

* Beings unable to understand the questionnaire.
* PHQ-9 scores ≥ 20.
* GAD-7 scores ≥ 15.
* Suicidal thoughts/behaviors in the past one month or history of suicide, etc.
* Severe psychiatric disorder in the judgment of the investigator prevents completion of the trial.
* History of serious illness, mental illness, medication use, and uncontrolled poor sleep habits that the investigator believes interfere with the study evaluation or the safety of the subject.
* According to the precautions listed in the instructions, there are any contraindications or other conditions for which the use is prohibited (such as narcolepsy, severe liver damage, pregnant, nursing or pregnant women, etc.).
* Other conditions not considered appropriate for participation by clinicians.
Understanding Risk Factors Involved in Developing a Second Blood Clot.

The purpose of this study is to develop a way to predict which patients diagnosed with idiopathic blood clots can safely stop warfarin therapy after six months. We will use patient characteristics, blood test results and imaging test results to identify those patients who have the lowest risk of developing a new blood clot after warfarin is stopped.

The risk of recurrent VTE in patients with idiopathic VTE subsequent to three to six months of oral anticoagulant therapy remains high (5-27% per year). The risk of recurrent VTE, however, is not likely high enough to justify indefinite anticoagulation in all patients with a first idiopathic VTE due to the rate of major bleeding with oral anticoagulants (2-6% per year), the inconvenience and cost of oral anticoagulant therapy, monitoring of oral anticoagulant therapy (e.g. prescription costs, time off work to go for lab tests, parking etc) and the lifestyle limitations of oral anticoagulant therapy (avoidance of certain physical activities, dietary restrictions, avoidance of pregnancy). Further, as some have argued, perhaps all that anticoagulant therapy achieves is to delay recurrent VTE and, as a recent editorial suggested, a tailored approached is required to determine sub-groups who require lifelong anticoagulation. A means to stratify patients with idiopathic VTE to identify a group at low risk of recurrent VTE who could safely discontinue oral anticoagulants subsequent to six months of therapy would be a significant advance in the care of these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Objectively proven (as previously described (8)) proximal idiopathic deep vein thrombosis or pulmonary embolism. Idiopathic will be defined as VTE occurring in the absence of fracture, plaster cast, immobilization greater than 3 days or a general anesthetic in the last three months prior to VTE diagnosis; a known deficiency of antithrombin, protein C or protein S; and malignancy in the last five years
2. Patients treated initially with a minimum of five days of heparin or low molecular weight heparin and oral anticoagulants with a target intensity of 2.0 - 3.0 with no recurrence in the subsequent six months.
3. Patients currently on oral anticoagulants

Exclusion Criteria:

1. Recurrent idiopathic VTE (i.e. \&#8805; 2 previous idiopathic VTE). Previous secondary VTE is not an exclusion criterion;
2. Age \&lt;18;
3. Known deficiency of proteins S, protein C or antithrombin;
4. Known, persistently positive anticardiolipin antibodies (titers \&gt; 30U/ml);
5. Known, persistently positive lupus anticoagulant;
6. Combined thrombophilic defects (e.g. homozygous for FVL or PGM, or compound heterozygous for FVL and PGM);
7. Refusal of informed consent.
A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug

This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to compare the safety, tolerability, and efficacy of ABT-494 Dose A once daily (QD) and Dose B QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and Dose B QD in subjects with PsA who have completed Period 1.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria
* Participant has active disease at Baseline defined as \>= 3 tender joints (based on 68 joint counts) and \>= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
* Diagnosis of active plaque psoriasis or documented history of plaque psoriasis
* Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) or intolerance to treatment with at least 1 bDMARD.

Exclusion Criteria:

* Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib)
* Current treatment with \> 2 non-biologic DMARDs or use of DMARDs other than Methotrexate (MTX), Sulfasalazine (SSZ), Leflunomide (LEF), apremilast, Hydroxychloroquine (HCQ), bucillamine or iguratimod or use of MTX in combination with LEF at Baseline.
* History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.
Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis

The primary purpose is to investigate the effect of Botox on the treatment of congenital muscular torticollis (CMT). The investigators' hypothesis is that a Botox injection will be an effective treatment when used in conjunction with current treatment procedures.

The babies that require a neck collar for CMT will be randomly placed into two groups. One group will receive standard treatment which includes physiotherapy and occupational therapy. The other group will receive standard treatment plus an injection of Botox. The babies will be monitored to determine if one group has a more favorable outcome than the other in terms of range of motion, length of treatment time and number of required surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Infants diagnosed with CMT and referred by family physician, pediatrician or orthopaedic surgeon
* Initial assessment and initiation of treatment prior to 4 months of age
* Cervical spine radiograph, no focal bony abnormality
* Head tilt greater than 5 degrees at 5 months of age
* Lateral head righting past neutral in upright suspension
* Restricted neck range of movement in lateral flexion or rotation or both
* Signed consent form and willingness to participate in the study
* Compliance with attending bi-weekly follow-up appointments

Exclusion Criteria:

* Any other diagnosis affecting tone or muscle function
* Any condition that would preclude an anesthetic
* Any vertebral abnormalities identified by radiograph
* Attending other health practitioners for treatment, i.e., massage therapist, chiropractor
* Any associated ocular problems as determined by a pediatric ophthalmologist
Randomized Crossover of SVG101(Dispersible Tab. of Everolimus) and Afinitor 5mg in Healthy Adults

The purpose of this study is to determine the pharmacokinetics and safety of SVG101 (dispersible tab. of everolimus) in healthy volunteers compared to Afinitor tab. after oral administration.

This is a randomized, open-label, single-dose, two-way cross-over study to investigate the Pharmacokinetic characteristics and safety after oral administration of SVG101 (dispersible tablet of everolimus) 5mg and Afinitor 5mg in 26 healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults: 19y - 55y (Male or Female)
2. Male: more than 55kg, Female: more than 50kg body weight
3. Body mass index: more than 18.5kg/m\^2 and less than 27.0kg/m\^2
4. Menopause or surgical infertility female

Exclusion Criteria:

1. Participants have or had a history of the clinically relevant disease or abnormalities in the hepatobiliary system, kidney, nervous system, immune system, respiratory system, urinary system, digestive system, endocrine system, blood/tumor, cardiovascular system, and mental illness.
2. Participants with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
3. Any history of gastrointestinal disease or surgery
4. Participants have hypersensitive to the everolimus or other rapamycin derivatives or other components of the investigational product.
5. Taking any drugs that induce or inhibit metabolizing enzymes such as barbiturate drugs within 30 days prior to first administration
6. Receiving any investigational therapy of others within 180 days prior to first administration. In case of biological products, the restricted period can be extended depend on the half-life receipt product
7. Pregnant or breastfeeding women
Efficacy of Short-course Blinatumomab for MRD Erradication in B-ALL

Detectable measurable residual disease (MRD) is the most important prognostic factor for B-cell acute lymphoblastic leukemia (B-ALL) for overall survival (OS) and disease-free survival (DFS). Patients who are MRD positive and have no access to novel immunotherapies should receive an allogeneic hematopoietic stem cell transplantation (HSCT). Blinatumomab is considered a standard of care (SOC) for this group of patients, however, the ideal treatment dose for MRD is unknown as doses were adjusted from the relapsed/refractory setting. Preliminary data suggest short cycles of blinatumomab can also be effective in states of lower disease burden prior to transplant. Thus, the investigators are performing a phase 2 trial assessing 7 days of blinatumomab as a bridge to HSCT

Primary endpoint is assessing the MRD response following a short-course blinatumomab infusion in patients with B-ALL with complete response (CR) and have detectable MRD disease who are candidates for HSCT. Secondary endpoints include incidence of adverse events, OS, DFS, percentage of patients who receive HSCT, incidence of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS)

During the proposed treatment, blinatumomab therapy will be assigned as follows:

Blinatumomab 17.5 mcg per day for 2 days, followed by blinatumomab 28 mcg per day for 5 days. Dexamethasone 20 mg will be applied one hour before starting dose.

The immunotherapy will be applied as a 24-hour continuous infusion. The scheduled appointments will be on the initial day of blinatumomab, when the patient will be discharged from hospital and evaluation will be performed on day 10 with bone marrow aspiration and MRD assessment trough next generation flow cytometry. The results will be given at the appointment on day 14, along with an assessment profile for HSCT.

Eligibility Criteria:
Inclusion Criteria:

* Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia
* MRD detectable in complete response (above the limit of quantification according to FCM)
* Performance status 0-2 on the ECOG scale
* No prior organ damage
* Having a potential related or unrelated donor

Exclusion Criteria:

* Performance status on the ECOG scale \>2
* HCT-CI \>3 points
* Patients who do not wish to participate in clinical study.
* Active central nervous system infiltration (CNS3)
* Active extramedullary disease
* Having previously received blinatumomab
* Absence of related or unrelated donors
Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization

In this prospective observational study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in healthy subjects, and their susceptibility to chlorehexidine. We plan to recruit 100 healthy volunteers secondary endpoints are to determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal of predominant GNB colonization.

In this prospective observational study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in 100 healthy subjects, and their susceptibility to chlorehexidine. Each participant will undego a oropharyngeal swab collection and a rectal swab at day 0. The Gram-negative bacilli colonization will be identified, E. coli isolates will be studied in terms of phylogeny; gram-negative isolates will be studied in terms of antimicrobial and chlorhexidine susceptibility. The primary objective is to determine the prevalence of oropharyngeal Gram-negative bacilli colonization. The secondary objectives are to determine the chlorhexidine and antimicrobial susceptibility of such colonization; to determine the phylogentic characteristics of oropharyngeal and rectal predominant E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal E. coli isolates.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 yo
* personal history of neck or face irradiation
* no history of gastrointestinal disease
* no symptoms of immunosuppression
* no antibiotic therapy in the previous month
* no hospitalization in the 3 months preceding inclusion
* medical exmination prior to inclusion

Exclusion Criteria:

* affiliated to the social security
* The refusal of a patient to participate in a study
Clinical Assessment of Color Stability and Patient Satisfaction for Polished Versus Glazed Lithium Disilicate Glass Ceramic Restorations and Patient Satisfaction

Dental overglaze is consist of colorless glass powder and applied to the fired crown surface to provide a glossy surface,Adjustment procedure break the production of the glaze layer through a natural glaze or overglaze process and create a rough surface, glazing or polishing after adjustment procedures is important to enhance the appearance of the restoration

Dental overglaze is consist of colorless glass powder and applied to the fired crown surface to provide a glossy surface. Natural glaze is a vitrified layer that is formed on the surface of the porcelain containing a glass phase when the porcelain is heated to a glazing temperature for a specific time, Adjustment procedure break the production of the glaze layer through a natural glaze or overglaze process and create a rough surface, The color of porcelain restorations is affected by surface roughness because rough surface reflects light irregularly and less than a glazed surface . Therefore, glazing or polishing after adjustment procedures is important to enhance the appearance of the restoration .

Although glazed surfaces appeared whiter, the CIE L\* value measured with the specular component excluded (SCE) geometry was lower than that of polished surfaces (28).Several reports have investigated different polishing techniques that support the use of polishing as an alternative for glazing of ceramic restorations .

Polishing can reduce chair time, eliminates laboratory procedures, infection control may be obtained . Polishing is also important for the porcelain surface for esthetic so several different techniques have been described for repolishing porcelain surfaces in the mouth .

Eligibility Criteria:
Inclusion Criteria:

* All subjects are required to be:

  1. From 18-50 years old, be able to read and sign the informed consent document.
  2. Physically and psychologically able to tolerate conventional restorative procedures
  3. have no active periodontal or pulpal diseases, have teeth with good restorations
  4. Willing to return for follow-up examinations and evaluation

Exclusion Criteria:

* 1. Patients in the growth stage with partially erupted teeth 2. Patients with poor oral hygiene and motivation 3. Pregnant women's 4. Psychiatric problems or unrealistic expectations
Genetic Analysis of Familial Hypertrophic Cardiomyopathy

To map the genetic defect responsible for familial hypertrophic cardiomyopathy.

BACKGROUND:

Familial hypertrophic cardiomyopathy is a disease of heart muscle that is genetically transmitted as an autosomal dominant trait, with a high degree of penetrance. Affected individuals typically have asymmetric thickening of the interventricular septum often involving the adjacent left ventricular free wall. Histologically, myocardial cells are enlarged and muscle bundles are grossly disorganized, producing a whorled pattern. The physiologic consequence of this cardiomyopathy is diastolic dysfunction with impaired ventricular relaxation and elevated diastolic pressures in the heart and pulmonary vasculature. Patients can experience dyspnea, angina, palpitations, and syncope. Complications of the disease include atrial fibrillation, congestive heart failure, thromboembolism, and most importantly, sudden death.

DESIGN NARRATIVE:

The three kindreds studied included one in Iceland, one in the St. Lawrence region in Canada, and one in the Pittsburgh, Pennsylvania area. Pedigrees were established for the three kindreds. All family members were clinically evaluated by physical exam, electrocardiogram, and comprehensive M-mode and two-dimensional echocardiography. Lymphoblastoid cell lines were derived from all members of the three pedigrees. Restriction fragment length polymorphism analyses were used to identify a DNA probe that was linked to familial hypertrophic cardiomyopathy. Studies were conducted to determine if the familial hypertrophic cardiomyopathy locus was the same in all three kindreds and to identify the gene responsible.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria