cyrilzakka/clinical-trials huggingface dataset:
Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer

The Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer Trial (RESTRICT).

The primary objective is to reduce the number of units of allogenic blood transfusion in locally advanced kidney cancer (≥ cT2). Secondary objectives include reduction in perioperative complications, assessment of recurrence free-survival and improving overall survival.

The Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer Trial (RESTRICT) is a randomized study to investigate blood sparing using autologous normovolemic hemodilution (ANH) or cell salvage at the time of nephrectomy for locally advanced kidney cancer after assessing inclusion criteria patients will be randomized to undergo standard blood management including the possibility of allogenic transfusion vs autologous blood transfusion. There are multiple ways patients can receive allogenic or autologous blood, including veno-venous bypass or cardiopulmonary bypass (typically reserved for patients with a thrombus above the level of the hepatic veins or entering the heart).

Eligibility Criteria:
Inclusion Criteria:

* Renal masses ≥ cT2 (by any conventional imaging).
* N1 or M1 disease is allowed if they are deemed surgical candidates (including cytoreductive nephrectomy).
* Male and female patients.
* 18 and older.
* Ejection fraction (EF) ≥ 45% by echocardiogram (ECHO).
* Adequate organ function as defined by:

  * Hemoglobin ≥ 9 g/dL. Pre-operative allogenic blood transfusion is allowed.
  * Platelets ≥ 100.000/μl.
  * Albumin ≥ 2.5 g/dL.
  * Aspartate Aminotransferase (AST) and alanine transaminase (ALT) ≤ 75U/L or total bilirubin ≤ 2.0 mg/dL.
  * WBC within institutional normal limits.
  * PT within institutional normal limits.
  * INR \< 1.5 and PTT normal.
  * Consent and compliance with all aspects of the study protocol.

Exclusion Criteria:

* Male and female younger than 18 years old.
* Non-surgical candidate
* Unstable angina.
Relationship Between Q-tip Test and Urethral Hypermobility

Q-tip test was applied for evaluation of urethral hypermobility (UH) in stress-incontinent women. It is still unknown whether there is an alternative method for the assessment of UH in a less invasive way or not.

We aim to assess the correlation between the overall rest-stress distance measured by transperineal ultrasound (TPUS) and Q-tip test angle in women with urodynamic stress incontinence (USI) scheduled for mid-urethral sling surgery (MUS), and determine a cut off value of rest-stress distance for predicting UH.

Between January 2009 and January 2014, women with urodynamic stress incontinence (USI) scheduled for mid-urethral sling surgery in the urogynecological department of a tertiary referral center were recruited. A retrospective chart review was performed. This study received approval from the Institutional Review Board of Kaohsiung Medical University Hospital (ID:KMUHIRB-E(I)-20210275), by which relevant guidelines and regulations were followed accordingly. Informed consent was obtained from all participants before surgeries. The Q-tip test was performed via a cotton swab with the patient in a 45-degree reclining. After lubricated with 2% lidocaine jelly, the cotton swab was inserted with the tip over bladder neck. The angle changes from rest to maximal straining were obtained for 3 times, and the maximum of angle change was recorded. The TPUS was performed by two experienced urogynecologist according to KMUH-TPUS protocol. The Voluson General Electric Sonography, expert 730 type (GE, Healthcare Ultrasound, Zipf, Austria) Ultrasonography was used with 3.5 MHZ curved linear-array transducer placed between the major labia and underneath the external urethral orifice. The measurement was done on the midsagittal plane to obtain the image of pubic symphysis, urethra, and bladder in a view. Ultrasonic measurement of the overall rest-stress distance was define as the linear distance of bladder neck position change from resting status to maximal strain. The rest-stress distance was obtained for 3 times, and the maximum of distance was recorded. The primary outcome of this study was the correlation between the angle of Q-tip test and the overall rest-stress distance of bladder neck in TPUS. The secondary outcome was the optimal cut off value of the rest-stress distance to predict UH.

Eligibility Criteria:
Inclusion Criteria:

* Women with urodynamic stress incontinence (USI)
* Scheduled for mid-urethral sling surgery

Exclusion Criteria:

* Women with more or equal to stage 2 pelvic organ prolapse (POP) defined by POP-quantification system (POP-Q) and received concomitant transvaginal mesh (TVM) surgery
* Women with incomplete ultrasound records
The Effect of RF Genicular Nerve Block Applied in the Preoperative Period on Fast-track Total Knee Arthroplasty

In our study, investigators plan to compare the preoperative RF and genicular nerve ablation approach in patients who underwent TKA(Total Knee Arthroplasty) using the Fast-Track protocol in terms of meeting postoperative pain, function and early discharge criteria.

One of the most important components of surgery using Fast-Track is the application of effective and well-monitored pain treatment. Post-surgical pain negatively affects the patient's early mobilization. Reduction in pain after TKA(Total Knee Arthroplasty) may not only increase short-term functional results but also increase the patient's overall satisfaction.

Genicular Nerve Radiofrequency Ablation (GNRFA) is a non-surgical treatment increasingly used in patients with advanced knee osteoarthritis. Previous studies have shown this to be an effective and safe method to reduce pain and improve functionality in this patient population.

Neurolysis of genicular nerves with radiofrequency (RF) may be useful to relieve pain and improve both function and quality of life in patients with post-TKA pain.

Investigators thought that reducing the pain of patients who underwent TKA with Fast-track in the postoperative period would contribute to early mobilization and therefore rapid functional recovery. As a result of previous studies, investigators know that genicular nerve neurolysis with RF Ablation in the preoperative period provides a reduction in postoperative pain.

Investigators routinely apply TKA applications in clinic with Fast-Track. In investigators hospital's algology outpatient clinic, genicular nerve RF ablation is routinely performed under USG or fluoroscopy guidance. In investigators study, investigators plan to compare the preoperative RF and genicular nerve ablation approach in patients who underwent TKA using the Fast-Track protocol in terms of meeting postoperative pain, function and early discharge criteria

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 40 and 85,
* Being able to understand verbal and written information given in Turkish,
* Being able to speak and understand Turkish,
* Being subjected to unilateral TKA surgery due to the diagnosis of Primary Knee osteoarthritis

Exclusion Criteria:

* Patients planned for revision knee prosthesis surgery,
* Patients previously diagnosed with psychiatric disorders,
* Patients who have undergone major surgery on the extremity where TKA will be applied,
* Patients with comorbid diseases such as rheumatoid arthritis or cancer,
* Patients with a score above 3 according to the American Society of Anesthesiologists (ASA) scoring,
* Patients with neurological diseases that cause functional disability,
* Patients with flexion limitation of more than 45 degrees and extension limitation of more than 20 degrees,
* Patients who have to use hypnotic or anxiolytic drugs regularly,
* Patients with alcohol or drug addiction,
* Patients with bleeding disorders
* Patients with uncontrolled diabetes
An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip Involvement

The purpose of this observational (a study that follows participants forward in time) study is to compare the functional improvement of hip joint using Harris hip score between 2 treatment groups (infliximab and conventional therapy) at Week 30 in ankylosing spondylitis (an autoimmune disease causing chronic inflammation at tendon ends and ligament attachment points) participants with hip involvement.

This is a multi-center (when more than 1 hospital or medical school team work on a medical research study), observational study to compare the effectiveness of infliximab with conventional therapies in ankylosing spondylitis participants with hip joint involvement. The study will be conducted in 3 parts: a 14-day screening, a 30-week first follow-up (Follow-up 1), and an additional 22-week follow-up (Follow-up 2) up to Week 52. Participants will be assigned to two groups based on the current treatments they are receiving: cohort 1 participants receiving infliximab with or without combination of disease modifying drugs (DMARDs-such as Sulfasalazine, Methotrexate and Thalidomide) and/or non-steroidal anti-inflammatory drugs (NSAIDs) and in cohort 2 who are receiving DMARDs and/or NSAIDs for treatment of pain will be observed. Participants will primarily be assessed for change in harris hip score. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ankylosing spondylitis (AS) (according to the modified New York Criteria for AS) at least 3 months prior to the Day 1 in the Follow-up I phase with symptoms of active disease atScreening/Baseline
* Hip pain and duration of hip symptom less than 2 years
* Harris hip score less than (\<) 70
* Hip involvement proven by Magnetic resonance imaging (MRI)
* Being treated with infliximab and conventional therapy for 2 weeks to 6 months

Exclusion Criteria:

* Participant has a history of hip joint disability which was considered irreversible
* Participant has a history of hip joint replacement
* Participant has a history of treatment with biologics other than infliximab less than 6 months prior to study entry
Healthcare Utilization and Economic Burden of Cardiomyopathy in China

Cardiomyopathy is the most common inherited cardiovascular disease, showing family aggregation, and it has a huge psychological and economic burden on family members. In this study, the investigators collected clinical information and costs of patients hospitalized with cardiomyopathy and establish a database to evaluate the economic burden of cardiomyopathy.

This study conducted a retrospective survey of hospitalized patients with cardiomyopathy aged ≥18 years in 13 centers in China from March 1, 2017 to March1, 2022. The investigators collected demographic and clinical information as well as healthcare utilization data of patients hospitalized with cardiomyopathy so as to evaluate the economic burden of cardiomyopathy in China.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with primary discharge diagnosis meeting one of the following subtypes of cardiomyopathy were enrolled, including HCM, DCM, ACM, RCM, left ventricular non-compaction, cardiac amyloidosis, Fabry disease, Pompe disease, Danon disease, and PRKAG2 cardiac syndrome.

Exclusion Criteria:

* none
Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled Trial

The study design is a multicentric randomized controlled non-inferiority trial. 160 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (80 in each group). The aim of the study is to assess the efficacy rate and the safety 2 years after root canal obturation undertaken using a ready-to-use calcium silicate sealer (PA1704) compared to the control calcium silicate sealer BioRoot™ RCS.

Procedures of root canal treatment will be conventional and standardized for all investigational centers. The canals will be cleaned, shaped and then obturated using a calcium silicate sealer (the ready to use sealer PA1704 or BioRoot™ RCS) with a single cone technique or cold lateral condensation of gutta-percha. Follow-up assessments will be conducted at 6, 12 and 24 months in both groups. The performance and safety of the sealer PA1704 will also be evaluated at 3.5 and 5 years after surgery. Retroalveolar radiographs will be taken at each study visit. The preoperative, postoperative and follow-up clinical and radiographic data will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female (age ≥ 18 years)
* Patient requiring a primary or a secondary root canal obturation on a single or multi-rooted tooth,
* Patient geographically stable who can be followed by the same investigator site for 2 years,
* Informed consent signed,
* Patient with social protection

Exclusion Criteria:

* Patient with one or more documented contraindication to endodontic treatment,
* Contraindication to the use of calcium silicate root canal sealer, such as an immature tooth or a known hypersensitivity to one component of the sealer formula,
* Endodontic treatment on tooth with calcified root canal assessed radiographically,
* Endodontic treatment on tooth with suspected perforation,
* Patient with an uncontrolled systemic disease such as diabetes or thyroid disorders, or with an immunocompromised condition or who has undergone radiation therapy to the jaw.
* Patient suffering from uncontrolled active periodontitis, not supported
* Participation to another interventional clinical study at the same time,
* Vulnerable subjects referred to in articles L.1121-5 to 8 and L.1122-1-2 of the Public Health Code and article 66 of Regulation (EU) 2017/745 on medical devices are excluded from the investigation (such as known pregnancy or lactation, patients with legal protection).
Safety and Pharmacology of Stanate

The purpose of this study is to evaluate the effect and safety of Stanate (stannsoporfin) in infants who are at risk for an exchange transfusion and meet the criteria of the protocol.

The present study evaluated the relationship between Stanate® dose, drug safety, and efficacy in a non randomised sequential open label cohort design, in 55 patients. Subjects were term and near term infants at medium or high risk of hyperbilirubinemia with TSB levels approaching the threshold for exchange transfusion. The first cohort began at a dose of stannsoporfin 0.75 mg/kg of birth weight intramuscularly. The dose was then increased to 1.5 mg/kg for cohort 2, and saline was given (placebo) for cohort 3. Safety evaluations consisted of hepatic, renal and hematologic clinical laboratory tests along with serial physical examinations. Long term follow up of all patients to age 6 is planned.

Eligibility Criteria:
Inclusion Criteria:

* Term and near-term healthy infants (may be no more than 14 days of age) with excessive hyperbilirubinemia who are at risk for exchange transfusion according to the AAP guidelines of 2004

Exclusion Criteria:

* No parental consent
* Major known congenital anomaly
* Current use of antibiotics, cardio-respiratory instability, abnormal renal function, hepatitis (as related to TORCH infections)
* Phenobarbital use in either child or mother (30 days prior to child's birth)
Study of TNFerade™ Gene Therapy, Radiation, 5-FU and Cisplatin in Esophageal Cancer

The primary purpose of this study is to assess the safety and feasibility of giving TNFerade™ with 5-FU, Cisplatin and radiation therapy to patients with locally advanced, esophageal cancer prior to surgical resection. TNFerade™ is a replication deficient (E1, E3 and E4 deleted) adenovirus vector containing the gene for TNF-alpha controlled by a radiation inducible promoter. This allows the expression of TNF-alpha to be greatest in the area receiving radiation. TNF-alpha is a potent cytokine that has been shown to have potent anti-cancer activities but, due to systemic toxicity, could not be delivered at effective doses. TNFerade™ is a novel way of selective delivery of TNF-alpha to tumor cells.

TNFerade™ will be delivered once a week for five weeks by direct intratumoral injection by using endoscopy or Endoscopic Ultrasound. 5-FU (1000 mg/m2/day) will be delivered via continuous infusion for 96 hours during weeks 1 and 4. Cisplatin (75 mg/m2) will be delivered on Day 1 and Day 29 intravenously. The dose of radiation delivered will be 45 Gy in 1.8 Gy fractions for 5 weeks.


Eligibility Criteria:
Inclusion criteria:

* 18-75 years for age;
* Patients with biopsy proven locally advanced adenocarcinoma or squamous cell carcinoma of the esophagus, stage II, III, who have not received previous treatment and are considered to have resectable carcinoma;
* Informed consent;
* Karnofsky performance status ≥ 70%;
* Life expectancy greater than 6 months.

Exclusion criteria:

* Diagnosis of lymphoma of the esophagus;
* History of other malignancy in the past 2 years except carcinoma in situ of the cervix or bladder, non-melanomatous skin cancer or localized early stage prostate cancer with patients continuously disease-free;
* Previous chemotherapy or radiation for esophageal cancer or previous radiation therapy to the target field;
* T4 disease, metastatic (stage IV) disease or confirmed invasion of the bronchial tree;
* Extension beyond 2 cm into stomach;
* Liver enzymes \>2.0 x ULN (ALT, AST, bilirubin, alkaline phosphatase);
* Coagulopathy (INR \>1.5, PTT ratio \>1.5);
* Renal insufficiency (creatinine \>2.0 mg/dL; calculated creatinine clearance \<50 ml/min);
* Significant anemia (hematocrit \<28% or hemoglobin \<9 g/dL) (may have RBC transfusion), or thrombocytopenia (platelet count \<100,000/μL)l or leukopenia (WBC \<3,000/µL; ANC \<1,500 μL);
* Contraindication to endoscopic or EUS-guided delivery including obstructive lesions that can not be dilated to pass endoscope;
* Clinical evidence of active infection of any type, including hepatitis B or C virus;
* Due to the embryotoxic effects of chemotherapy, pregnant or lactating women, or men unable or unwilling to practice contraception are excluded;
* Experimental medications within the last four weeks prior to Day 1;
* Chronic systemic corticosteriod use (orally or parenterally administered);
* Significant concurrent medical or psychiatric illness as defined by the investigator.
Effect of Extracorporeal Shock Wave Therapy for Burn Scar Charateristics

No study has investigated the effect of extracorporeal shock wave therapy (ESWT) on hypertrophic scar characteristics. Thus, this study aimed to ascertain the effects ESWT on burn scars. The investigators retrospectively reviewed burn patients who had undergone autologous split-thickness skin grafting (STSG) with same artificial dermis between January 2012 and September 2019.

No study has investigated the effect of extracorporeal shock wave therapy (ESWT) on hypertrophic scar characteristics. Thus, this study aimed to ascertain the effects ESWT on burn scars. The investigators retrospectively reviewed burn patients who had undergone autologous split-thickness skin grafting (STSG) with same artificial dermis between January 2012 and September 2019. The ESWT group (n=17) received shock waves with low-energy flux density (0.05-0.30 mJ/mm2). The interval between treatments is a 1-week. The ESWT group also received standard treatment. The control group (n=18) only received standard treatment. We reviewed skin characteristics before and after 6 treatment sessions for both groups. The investigators checked skin charateristics(erythema, transepidermal water loss, sebum level, and elasticity). The investigators expect that ESWT is effective for significantly improving burn-associated scar characteristics and may be used for managing burn patients.

Eligibility Criteria:
Inclusion Criteria:

* a retrospective review of 35 patients who had undergone STSG between January 2012 and September 2019
* limited to the upper extremities(the upper arm, forearm, and hand)
* the scars which undergone STSG with same artificial dermis using Matriderm® (MeSkin Solution Dr. Suwelack AG, Billerbeck, Germany)

Exclusion Criteria:

* not evaluated serial assessments
* below 18 years age
Cognitive Behavioral Therapy in Panic Disorder

The investigators hypothesized that the group of patients receiving the medication interventions and CBT would show significant changes in their behavior, such as remission or reduction in anxiety, panic attacks, anticipatory anxiety, fear of body sensations, loss of control, and agoraphobia avoidance. And also, in the general evaluation of well-being, in the beginning and end of the treatment, in comparison to the control group (medication without CBT), during the same period.

This trial consisted in tracing the profile and evaluating their response to cognitive-behavioral techniques in a sample of 50 panic disorder patients with agoraphobia treated at the Psychiatric Institute of the Federal University of Rio de Janeiro/Brazil. Objective: To test a specific model of cognitive-behavioral therapy through instruments applied in the beginning and end of the procedures. Two groups of 25 patients were formed, the first one with medication and therapy and the second one with medication and without therapy, as the control group. Methods: The cognitive-behavioral therapy sessions were held weekly and individually, with one-hour sessions. The work focused on physiological, cognitive and behavioral aspects with techniques of cognitive reorganization, exercises of induction of symptoms, "in vivo" exposure, breathing and relaxation exercises. The prescribed medication consists of tricyclic antidepressants (TCA) or selective serotonin reuptake inhibitors (SSRI). Results: There was a significant difference between the initial and final evaluation of the group with the specific therapy, such as, reduction in panic attacks, anticipatory anxiety, agoraphobia avoidance, and fear of body sensations. In the global assessment functioning scale, global well-being increased from 60.8% to 72.5% among patients in the first group with therapy, differently from the group without therapy. We observed that 77.6% of the sample in both groups presented the respiratory subtype and 22.4% the non-respiratory subtype. Conclusion: The association of specific cognitive-behavioral therapy focusing on somatic complaints associated with pharmacologic treatment in the first group was effective in this sample, in comparison to pharmacological treatment alone in panic disorder patients with agoraphobia.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Both genders with a diagnosis of panic disorder and agoraphobia without severe comorbidities.

Exclusion Criteria:

* Patients showing alcohol or drug dependence
* Mental retardation
* Any other severe mental disorder.
Primary Birmingham Hip Resurfacing Arthroplasty Using a Metal-on-Metal Couple in the Young Active Patient

To prospectively obtain data about the clinical and radiological results of the resurfacing technique as primary hip prosthesis in young active patients


Eligibility Criteria:
Inclusion Criteria:

* Total hip prosthesis

Exclusion Criteria:

-