cyrilzakka/clinical-trials huggingface dataset:
Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection

Injection of OnabotulinumtoxinA (BTX-A) into the bladder is a widely used treatment option for patients with overactive bladder who have failed medical therapy. Urinary tract infection is the most common side effect of this procedure and therefore antibiotics are given around the time of injection in order to prevent these events. While antibiotics are commonly given at the time of injection, the duration of these antibiotic regimens are variable. The investigators propose a study to investigate different antibiotic protocols and their affect on the rate of urinary tract infection after injection.

Intravesical injection of OnabotulinumtoxinA (BTX-A) is a widely practiced third line therapy for non-neurogenic overactive bladder (OAB). However, a paucity of data exists regarding urinary tract infections (UTI), the most common adverse event following injection. The investigators propose a randomized, controlled cross-over trial to investigate the utility of commonly practiced antibiotic protocols and simultaneously derive information regarding risk factors for post-procedural UTIs and their affect on treatment efficacy.

The investigators plan to initiate a prospective, randomized non-inferiority cross-over trial, in which a participant receives peri-procedural antibiotics exclusively at the time of one injection, and then at a subsequent injection, completes a three-day course of antibiotics post-operatively in addition to the peri-procedural dose. Enrollment is planned to achieve a total of 68 participants. Participants will be evaluated at 3 weeks and 3 months following injection to identify adverse events and treatment success. Inter-injection time will be measured and used a surrogate for efficacy over multiple injections.

These results, in addition to filling a void in current literature regarding the increasingly utilized treatment with BTX-A, have the potential to modify clinical practice regarding antibiotic use and decrease rates of adverse events. The means to stratify patients based on their specific risk of UTI may be used to facilitate antibiotic stewardship and improve patient outcomes.

Eligibility Criteria:
Inclusion criteria:

* ≥ 18 years of age
* Medication refractory OAB, identified per American Urological Association guidelines

Exclusion criteria:

* Post void residual urine \>150ml on two occasions
* Untreated, symptomatic UTI
* Comorbid neurological conditions, including spinal cord injury, systemic neurologic illnesses (i.e. multiple sclerosis, Parkinson's disease) or central nervous system disease (i.e. brain tumor, stroke)
* Prior pelvic irradiation
* Current or prior bladder malignancy
* Hematuria lacking a clinically appropriate evaluation
* Chronic indwelling or intermittent catheterization
Transcranial Magnetic Stimulation (TMS) in Genetic Epilepsies

Transcranial magnetic stimulation (TMS) uses electromagnetic induction as an efficient, painless, non-invasive method to generate a suprathreshold current at the level of the encephalon, and provide in vivo measurements of cortical excitability and reactivity at the level of the motor cortex (TMS-EMG) or the entire cortical mantle (TMS-EEG). This study proposes TMS measurements as a diagnostic tool in patients to understand mechanisms of epileptogenesis related to genetic mutations, and prognostic to guide and monitor precision treatments.


Eligibility Criteria:
Inclusion Criteria:

* Children aged \>3 years and adults
* Diagnosis of epilepsy with presumed or confirmed genetic etiology. Diagnosis of genetic epilepsy is made by next-generation sequencing (NGS) analysis
* or Diagnosis of primary (non-hemicranial) headache, in the absence of alterations on neuroimaging, and no known genetic condition
* Obtaining informed consent

Exclusion Criteria:

* Age \<3 years
* Presence of contraindications to TMS: history of head or eye trauma with inclusion of metal fragments, cardiac pacemaker, arrhythmic heart disease, hearing implants, implantation of drug delivery devices, piercings or tattoos with metallic ink.
* Pregnancy status
A Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia

This is an open label randomized controlled phase II study of AS1411 combined with Cytarabine in the treatment of patients with primary refractory or relapsed acute myeloid leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AML as defined by the World Health Organization (WHO) classification (Vardiman 2009)
* Primary refractory AML (defined as a failure to achieve a CR or CRi after therapy with curative intent) or AML in first relapse
* ECOG Performance status 0, 1 or 2
* Age \> 18 and \< 70 years
* For patients presenting with primary refractory AML, \> 20% blasts on baseline bone marrow assessment
* For patients presenting with relapsed AML, \> 5% blasts on baseline bone marrow assessment

Exclusion Criteria:

* An initial diagnosis of acute promyelocytic leukemia (as defined by French-American-British criteria (Bennett 1976))
* Secondary AML, defined as AML evolving from antecedent hematological disorder or prior exposure to leukemogenic therapy or agent
* Clinically active CNS leukemia
* Previously received a total cumulative dose of cytarabine \> 6g/m2 in the last 6 months
* Previously received \> 1 induction regimen (Defined as 1 or 2 cycles of a drug or a drug combination administered as remission induction therapy)
Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy

The purpose of this 2 phased, open-label study is to compare the safety and efficacy of etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin American subjects with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that allows the investigator to choose continuation with the phase I treatment or the addition, discontinuation or titration of other DMARD therapy already being utilized for the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis (RA)
* Currently receiving a suboptimal response to a stable dose of methotrexate for treatment of Rheumatoid Arthritis (RA)
* Active Rheumatoid Arthritis (RA) at time of screening and baseline

Exclusion Criteria:

* Previous or current treatment with etanercept, other tumor necrosis factor-alpha inhibitors, or other biologic agents
* Concurrent treatment with a Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, at screening
* Receipt of any Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, within 3 months before screening
Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children

Nasotracheal intubation is one of the anesthetic procedures required for oral surgery. It allows the surgeon easier access to the surgical site than the orthotracheal intubation. Therefore, nosotracheal intubation is commonly used for general anesthesia for oral and maxillofacial surgery and dental treatment. However, nasotracheal intubation can damage the nasal mucosa in the course of the tube passing through the nostrils, causing epistaxis which is reported as the most common side effect.

In order to reduce these side effects, heating of the tube and use of a tube lubricant immediately before intubation have been recommended in children. However, research on whether the dry state of the mucosa itself contributes to the development of epistaxis is limited. A study in adults reported that pretreatment of the ointment on the mucosa reduced the damage to the mucosa. However, its effect on the incidence of epistaxis in children has not been studied.

The purpose of this study is to investigate the effects of pretreatment of nasal ointment on epistaxis of nasotracheal intubation in children.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical statue I or II
* Patients scheduled to undergo surgery under nasotracheal intubation

Exclusion Criteria:

* expected difficult intubation based on history, physical examination, weight.
* bleeding tendency
* upper respiratory infection within the previous 14 days
The Role of Pyroptosis in Chronic Venous Disease

Enrollment criteria and clinical data collection: following the principles of medical ethics, the development of inclusion and exclusion criteria. Selecting 200 cases of chronic venous disease (CVD) according to the Comprehensive Classification System for Chronic Venous Disorders (CEAP) divided into 6 Clinical stages (C1-C6) (Group A). Selecting 200 healthy participants without CVD (C0) as controls (Group B). Blood samples will be collected from both groups. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated between the two groups and between the subgroups, according to clinical stage, in group A.

Pyroptosis is a pro-inflammatory form of regulated cell death and is dependent on networks of extracellular fibers (NET,s), on the enzymatic activity of inflammatory proteases that belong to the family of cysteine-dependent aspartate-specific proteases (caspase), and cytokines. The role of inflammation has been previously demonstrated in chronic venous disease (CVD), which is a condition that affects up to 80% of adult population in western countries.

According to the Comprehensive Classification System for Chronic Venous Disorders (CEAP) divided into 6 Clinical stages:

C0: no visible or palpable signs of venous disease. C1: telangiectasies or reticular veins. C2: varicose veins. C3: edema. C4a: pigmentation and eczema. C4b: lipodermatosclerosis and atrophie blanche. C5: healed venous ulcer. C6: active venous ulcer.

The aim of this study is to evaluate the role of pyroptosis in the onset and progression of CVD.

The Investigators will select 200 participants with chronic venous disease (CVD) according to Clinical stage of CEAP (C1-C6 patients) \[Group A\] . The investigators will also select 200 healthy participants without CVD (C0) as controls \[Group B\].

Peripheral vein blood samples will be collected from both groups. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated between the two groups and between the subgroups of group A, according to clinical stage.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Venous Disease (C1-C6 CEAP classification )

Exclusion Criteria:

* Peripheral artery disease
* Malignant Tumors
* Severe cardiovascular and cerebrovascular disease
* Liver and kidney failure
Clinical Evaluation of the Antidepressant Effect of the Use of Probiotics in Bipolar Disorder

Bipolar Disorder (BD) is highly incapacitating and associated with premature mortality. Depressive symptoms and episodes are the most frequent cause of disability in subjects with BD and over half of patients do not respond adequately to approved treatments for this condition, showing the need for new classes of treatments to complement current pharmacotherapy. Previous studies demonstrated that the intestinal flora have potential positive or negative effects on the Central Nervous System and suggest that adding specific strains of bacteria to people's diet may have antidepressant properties.The study proposes to evaluate the clinical benefit of adding probiotics to pharmacological treatments for bipolar depression. This will be a study with 84 subjects (42 receiving probiotics and 42 placebo). The research team in this department has focused especially on non-pharmacological treatments for bipolar disorder (psychotherapy, nutrition and exercise) and is multidisciplinary in scope with psychiatrists, psychologists, nurses, physiotherapists and nutritionists participating in research projects.

It will test, in a proof-of-concept study, the antidepressant efficacy of adjunctive administration of probiotics in bipolar depression and evaluate potential inflammatory and metabolic markers associated with response to treatment. With this objective, 84 individuals with bipolar disorder type I or type II presenting subsyndromal depressive symptoms or a major depressive episode will be recruited. The study design lasts 12 weeks and is expected to last two years.

Eligibility Criteria:
Inclusion Criteria:

* BD type I or type II, according to the use of Mini Internacional Neuropsychiatric Interview (MINI)
* Score on the Young Mania Rating Scale (YMRS) \< 8
* Score on the Montgomery-Asberg Depression Rating Scale (MADRS) \> 8
* Be receiving major guideline-approved treatments for bipolar depression for at least 4 weeks

Exclusion Criteria:

* Pregnant or lactating women
* Substance or alcohol dependence
* Patients on prolonged antibiotic therapy, immunosuppressive therapies
* A recent introduction of antidepressants in the last 15 days
* Use of another probiotic, either in the form of food, sachets, capsules and others
Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as capecitabine and paclitaxel (albumin-stablized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II/III trial is studying how well giving capecitabine together with paclitaxel (albumin-stabilized nanoparticle formulation) works in treating women undergoing surgery for stage II or stage III breast cancer.

OBJECTIVES:

Primary

* Determine the rate of pathological complete response (i.e., tumor completely gone) in women with previously untreated, unresected, stage II-IIIB breast cancer treated with neoadjuvant therapy comprising capecitabine and paclitaxel (albumin-stabilized nanoparticle formulation) (Abraxane\^®).

Secondary

* Evaluate the safety of this regimen in these patients.
* Determine overall clinical response rate in patients treated with this regimen.

OUTLINE: Patients receive up to 4 courses of capecitabine and paclitaxel (nanoparticle albumin-stabilized formulation) (Abraxane\^®) in the absence of disease progression. Patients then undergo definitive surgical resection of the tumor off study.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed infiltrating carcinoma of the breast or inflammatory breast cancer

  * Stage II-IIIB disease (T1-4, N1-2, M0)
* Previously untreated disease
* Previously unresected disease
* High-risk disease that is not resectable by lumpectomy alone
* Any HER2/neu status (positive, negative, or unknown) allowed
* Hormone receptor status:

  * Any estrogen/progesterone status (positive, negative, or unknown) allowed

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified
* ECOG performance status 0-2
* Life expectancy \> 3 months
* Absolute neutrophil count \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Hemoglobin \> 9.0 g/dL
* Creatinine \< 1.5 mg/dL
* Bilirubin \< 1.5 times upper limit of normal (ULN)
* ALT and AST \< 2.5 times ULN (5 times ULN if due to Gilbert's disease)
* Alkaline phosphatase \< 2.5 times ULN (5 times ULN if due to Gilbert's disease)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology

GynRAN is an international, multicentre, transversal, diagnostic and non-interventional study carried out in gynecology-obstetrics/gynecological oncology departments that aims to identify a diagnostic signature for gynecological pathologies by analyzing of coding and non-coding RNA contained in patients saliva.

The study population consists of patients with clinically symptomatic females with one or more of the gynecological pathologies (endometriosis, adenomyosis, ovarian cysts, fibroids, ovarian/cervical/uterine cancer) and asymptomatic females.

The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations necessary according to the context, which are carried out according to the local recommendations.


Eligibility Criteria:
Inclusion Criteria:

1. Subject of legal age (according to local legislation) and at least 18 years old
2. Subject (and if applicable her legal representative) having dated and signed the informed consent form
3. Subject with a medical insurance policy
4. Subject presenting to the department:

   1. With Symptoms (bleeding and/or pain and/or clinically observed symptom) of one or more of the following pathologies (suspected undergoing diagnostic surgery/biopsy or diagnosed and before any curative treatment of the pathology):

      * Endometriosis
      * Adenomyosis,
      * Ovarian cysts,
      * Fibroids,
      * Ovarian cancer,
      * Cervical cancer,
      * Uterine cancer.
   2. Asymptomatic with pap smear positive for cervical dysplasia or cervical cancer and before any curative treatment.
   3. Asymptomatic undergoing a pap smear for cervical cancer screening in a gynecological follow-up context.

Exclusion Criteria:

1. Recent (\<1 month) or ongoing bacterial or viral infection
2. Known active oral or digestive mycosis
3. Evolving oral pathology, symptomatic or obvious
4. Known pregnancy
5. Known current non-gynecological pelvic pathology
6. Subject with a diagnosed breast cancer or cancer other than gynecological with the exception of basal cell carcinoma
7. Subject with a history of treated cancer within the last 5 years with the exception of basal cell carcinoma
8. Subject who has already received chemotherapy or radiotherapy or undergone complete or partial excision of the gynecological pathology of inclusion criterion
9. Subject with significant difficulties reading or writing her language
10. Subject unable to comply with study and/or follow-up procedures
11. Participation in an interventional study with investigational drug or in the exclusion period of an interventional study.
The Effects of Music on the Anxiety and Sleep Quality of Pregnant Women on Bed Rest for a High-risk Pregnancy

The purpose of this study is to identify the effects of music on the anxiety and sleep quality of women with high-risk pregnancy having bed rest in the hospital in Turkey.

This randomized-controlled study involved 80 control and 80 experimental group with a high-risk pregnant woman .

The literature review indicates a limited number of studies on the effects of music in eliminating the anxiety and sleep problems in women with a high-risk pregnancy having bed rest in the hospital; the existing studies were found to be mainly about anxiety. The purpose of this study is to identify the effects of music on the anxiety and sleep quality of women with a high-risk pregnancy having bed rest in the hospital.

This study adopted a pretest-posttest randomized controlled study involved 80 control and 80 experimental group with a high-risk pregnant woman . The women in the experimental group listened to Acemaşiran music for 40 minutes in successive three days and two times a day.

Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the study
* Knowing Turkish and being literate
* Having been hospitalized for bed rest for at least 5 days.
* Having a gestational age of 28 to 36 weeks
* Being hospitalized due to at least one of the diagnoses including hypertensive diseases, diabetes mellitus, preterm labor, placenta previa, cervical insufficiency, or premature rupture of the membrane

Exclusion Criteria:

* Fetal congenital anomalies
* Having a hearing impairment
Oral Deforolimus With Trastuzumab for Patients With HER2-positive Trastuzumab-Refractory Metastatic Breast Cancer (8669-009)

This clinical trial will study the use of ridaforolimus in metastatic breast cancer subjects whose tumors have shown a resistance to trastuzumab (herceptin). The goal of this study is to find out if subjects treated with ridaforolimus in combination with trastuzumab have a positive response to the treatment, and if treatment with ridaforolimus in combination with trastuzumab prolongs survival.


Eligibility Criteria:
Inclusion Criteria:

* Female, 18 years of age or older
* Histologically confirmed HER2-positive metastatic breast cancer
* Trastuzumab-resistance
* Measurable disease, according to RECIST guidelines
* ECOG performance status less than or equal to 1
* Life expectancy greater than 3 months
* No prior treatment with temsirolimus, everolimus, rapamycin, or any other mTOR inhibitor
* At least 4 weeks must have lapsed between prior investigational therapy, chemotherapy or radiotherapy, and the first dose of ridaforolimus
* Left ventricular ejection greater than or equal to 50%
* Adequate cardiovascular function
* Adequate hematological, hepatic, and renal function
* Serum cholesterol less than or equal to 350 mg/dL and triglycerides less than or equal to 400 mg/dL
* Negative pregnancy test within 7 days prior to first dose of study drug and must use an approved contraceptive method from screening to 30 days after the last dose of study drug
* Availability and patient consent to obtain archival tissue samples
* Signed informed consent

Exclusion Criteria:

* Inadequate recovery from any prior surgical procedure or having undergone any major surgery within 2 weeks before trial entry
* Grade 1 or Grade 2 hypersensitivity reactions to prior trastuzumab therapy if these reactions prevented further trastuzumab administration
* Grade 3 or Grade 4 hypersensitivity reaction to prior trastuzumab
* Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest
* Known allergy to macrolide antibiotics
* Pregnant or breast-feeding
* Know history of HIV
* Diagnosis of brain metastasis or leptomeningeal carcinomatosis within 3 months
* Other malignancies within the past 3 years, except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
* Active infection requiring prescription intervention
* Newly diagnosed or poorly controlled Type 1 or 2 diabetes
* Other concurrent illness which, in the Investigator's judgment, would either compromise the patient's safety or interfere with the evaluation of the safety of the study drug
* Concurrent treatment with medications that strongly induce or inhibit cytochrome P450.
* Any condition that renders patient unable to fully understand and provide informed consent and/or comply with the protocol
CPET in Myocardial Ischemia

The investigators goal is to determine whether cardiopulmonary exercise testing (CPET) can be utilized in the diagnosis of myocardial ischemia. For the study participants the investigators will recruit patients who have been referred to myocardial perfusion PET/CT scan in Kuopio University Hospital. The participants will perform the CPET on a cycle ergometer on separate day after the perfusion scan. The investigators will compare the results of the PET/CT scan and CPET and evaluate if the possible perfusion defects detected in PET/CT correlate with the gas exchange parameters in CPET.

The patients who receive invasive coronary treatment (coronary bypass surgery or percutaneous coronary intervention) will be invited to perform additional CPET ja PET/CT tests six months after the treatment. The goal will be to determine whether the recovery of myocardial perfusion can be assessed with gas exchange parameters in CPET.


Eligibility Criteria:
Inclusion Criteria:

* Referral to coronary perfusion PET/CT scan in Kuopio University Hospital

Exclusion Criteria:

* Age under 18 years
* Pregnancy or breastfeeding
* Handicap
* Imprisonment
* Care under forensic psychiatry