cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA in Women With Overactive Bladder

A randomized, single blind, non-inferiority clinical study was performed evaluating the efficacy and safety of AbobotulinumtoxinA vs. IncobotulinumtoxinA intradetrusor injections in women with overactive bladder and urge urinary incontinence. Also the effect of local anesthesia on pain level of the procedure was assessed.

In the described prospective, clinical trial, approved by the National Medical Ethics Committee (protocol number: 0120-44/2018/5; date of approval: 22/02/2018), female patients were enrolled, followed by signed informed consent.

Before treatment patients underwent history and physical examination. Before botulinum toxin injection each patient completed three questionnaires, UDI-6 (Urogenital Distress Inventory), IIQ-7 (Incontinence Impact Questionnaire), I-QOL (Incontinence Quality of Life). The total score of each questionnaire was considered. Before botulinum toxin injection, urinalysis was performed to check for a urinary tract infection (UTI). For those presenting with UTI, treatment was postponed until the UTI was treated and a repeat urinalysis was performed. Nitrofurantoin 100 mg twice daily per os was given prophylactically on the day of the procedure. Patients were randomised to receive either 300 units of AbobotulinumtoxinA (Dysport®) or 100 units of IncobotulinumtoxinA (Xeomin®). They were further randomised to receive local anesthesia or placebo. 30 minutes before the procedure the bladder was instilled with either 40 ml 1% lidocaine solution using a 16Fr urethral Foley catheter or with 40 ml 0.9% NaCl solution. All patients received urethral lubrication gel. Using rigid cystoscopy, normal saline was used to dilute the vial to 20 ml. A total of 20 evenly distributed intradetrusor injections, 1 ml per site, were performed, 2 of them included the trigone area. During the procedure the patients graded the pain level of every injection on a Visual Analog Scale (VAS). All patients were treated in an outpatient clinic and by one experienced surgeon.

After 1 to 2 weeks patients were seen for evaluation of systemic side effects, physical examination, measurement of residual urine and urinalysis to eventually diagnose and treat a urinary tract infection. After 4 months patients were seen to evaluate the treatment result and complete the questionnaires, IIQ-7, UDI-6, patient satisfaction survey and I-QOL. Side effects were monitored for 5 months after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* female, age between 18 and 90, presence of urinary urgency with urgency urinary incontinence, residual urine below 150 ml, previous non-pharmacological conservative treatments (e.g., pelvic floor muscle training) inefficiency, anticholinergic or beta-3 agonist treatment inefficiency.

Exclusion Criteria:

* patients that already have received treatment with botulinum toxin, pregnancy or breast- feeding and any diseases or functional abnormalities that might affect bladder function. Patients with stress urinary incontinence.
Knee Injections for Obese Patients with Knee Arthritis

The purpose of this study is to assess obese patients with knee arthritis and determine the non-inferiority of a low dose steroid treatment vs. standard dose steroid treatment for two knee outcome measures: pain and function.


Eligibility Criteria:
Inclusion Criteria:

• Patients with BMI ≥30 kg/m2 and radiograph-proven knee osteoarthritis who are interested in receiving a steroid injection for knee arthritis.

Exclusion Criteria:

* BMI \< 30 kg/m2
* Uncontrolled diabetics with a hemoglobin A1c \> 8%
* No other treatment within the time frame of the study.
* Patients that are undergoing physical therapy at the time of the study.
Empa/Lina FDC Food Effect Study (Japan)

The trial will be performed as an open-label, randomised, single-dose, two-sequence crossover design for the assessment of effect of food on bioavailability of empagliflozin / linagliptin fixed dose combination (FDC) tablet.


Eligibility Criteria:
Inclusion criteria:

* Healthy male subjects age \>=20 and \<=45 years; body weight: \>=50 kg and \<=80 kg; body mass index: \>=18.0 and \<=25.0 kg/m2
* Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature)
* Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation

Exclusion criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
* Further exclusion criteria apply
Sleep, the Never-ending Quest of College Students

The purpose of this study is to evaluate whether undergraduate students completing a course focused entirely on sleep at a major urban university evidence positive changes in their sleep patterns compared to students completing a similar-level course (without any discussion of sleep) in the same department (Psychology) at the same university (UH). Potential changes in sleep patterns across the semester will be examined as well as whether putative changes in sleep can be linked with academic and mental health outcomes.

Aim 1) To evaluate whether a semester long course focused entirely on sleep produces improvements in college students' sleep patterns across the semester based on one-week sleep diaries.

H1: Compared to students enrolled in other courses who are not expected to show significant changes in sleep patterns, students enrolled in the sleep course will demonstrate increases in total sleep time, decreases in sleep onset latency, and decreases in nighttime awakenings. In line with Mayer's theoretical model, these sleep-based changes will evidence non-linear (i.e., quadractic) patterns across four time points during the semester.

Aim 2) To evaluate changes in sleep hygiene behaviors across the semester among students enrolled in a sleep course compared to students enrolled in other courses.

H2: Compared to students enrolled in other courses who are not expected to show significant changes in sleep hygiene behaviors, students enrolled in the sleep course will report a decreased frequency of naps, use of electronics within one hour of bed, and an increase in sleep regularity (e.g., reduction in the discrepancy between weekend and weekday wake times) across the four time points during the semester.

Aim 3) To evaluate how sleep patterns relate to daytime mood and energy levels across the semester among students enrolled in a sleep course and other courses.

H3: Greater total sleep time, shorter sleep onset latency, fewer nighttime awakenings, a less discrepancy between weekend and weekday wake times will predict higher energy levels and mood among both groups across the semester.

Aim 4) To evaluate how sleep patterns across the semester predict final course grades among students enrolled in a sleep course.

H4: Students enrolled in the sleep course who demonstrate increases in total sleep time, decreases in sleep onset latency, and decreases in nighttime awakenings across the semester will achieve higher final course grades than students who demonstrate minimal to no improvements in sleep.

Eligibility Criteria:
Inclusion Criteria:

* All undergraduate students at UH age 18 and older who are enrolled in the following upper-level courses and who provide consent to participate will be eligible to participate as control participants

Exclusion Criteria:

* Previous enrollment in PSYC 4397: The Behavior of Sleep course or a similar course.
Clinical Impact of Orsiro™ Stent in Patient With Chronic Kidney Disease

Orsiro™ or Orsiro_Mission™ stents have the biodegradable polymer and the thinnest stent strut (60㎛) in commercially available stents, which could minimize chronic inflammation and incomplete endothelialization. In several prior studies, ultrathin strut sirolimus-eluting stent (Orsiro®) showed better outcomes in terms of target lesion failure or target lesion revascularization compared to other contemporary stents. Chronic kidney disease (CKD) is known to be associated with adverse cardiovascular outcome including restenosis or stent thrombosis following percutaneous coronary interventin (PCI), because the patients with CKD have more complex coronary lesion characteristics, severe calcification, and diffuse plaque of the coronary artery. However, there is a paucity of data regarding clinical efficacy of Orsiro® in CKD population. Therefore, this study aims to investigate the differences in clinical outcomes according to renal function in patients undergoing PCI with Orsiro™ or Orsiro_Mission™ stents. After patients will be divided into three groups according to the renal function; normal or mild renal dysfunction (eGFR ≥ 60 ml·min - 1·1.73㎡), moderate renal dysfunction ( 30≤ eGFR\< 60 ml·min - 1·1.73㎡), and severe renal dysfunction (eGFR \< 30 ml·min -1·1.73㎡), the clinical outcome will be investigated among groups.


Eligibility Criteria:
Inclusion Criteria:

* 19 years of age or older
* Patient undergoing percutaneous coronary intervention with Orsiro™ or Orsiro_Mission™ stents

Exclusion Criteria:

* Patient with a life expectancy of less than one year
* Patient who used another drug-eluting stent for percutaneous coronary intervention at study registration time
* Cardiogenic shock
* Pregnancy
Diffusion Tensor Imaging of Median Nerve in Diabetic Peripheral Neuropathy

This study is a diagnostic accuracy study that aims to evaluate the role of DTI in evaluation of DPN in comparison to clinical scores and nerve conduction studies (NCS). The study included 30 patients with diabetes mellitus complaining of neuropathy symptoms and 15 healthy volunteers. All subjects underwent evaluation using 1.5T DTI of median nerves and NCS. Patients underwent clinical evaluation using Neuropathy Deficit Score (NDS), Neuropathy Impairment Score in the Lower Limbs (NIS-LL) and Diabetic Neuropathy Examination (DNE) score. The values of these tests were compared and correlated and diagnostic accuracy tests were performed together with identification of cut-off score for abnormal diffusion tensor imaging parameters in diabetic neuropathy


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients with symptoms suggestive of peripheral neuropathy.

Exclusion Criteria:

* Patients with evidence of nerve entrapment or neuropathy due to causes other than DM
Long Term Results of STARR With Contour Transtar

Obstructed defecation syndrome (ODS) is a widespread and disabling syndrome. With this study the investigators want to evaluate the long term results of Stapled Transanal Rectal Resection (STARR) performed with Contour Transtar device in the treatment of ODS. A re-evaluation of 113 patients subjected to STARR from June 2007 to January 2010 was conducted.


Eligibility Criteria:
Inclusion Criteria:

* ODS
* presence of a rectocele that did not empty and/or a recto-rectal or recto-anal intussusception.

Exclusion Criteria:

* anal sphincter contractile deficiency
* previous rectal resection
Comparison of a Speech-Language Assessment Tool for Pragmatic and Discourse Skills in Schizophrenia Spectrum Disorders

The scientific literature has largely objectified language disorders in schizophrenia. And more precisely, the impairment of pragmatic and discursive language skills. Currently, there is no standardized language assessment tool specific to these patients. The aim of this study is to compare the effectiveness of a newly developed speech-language assessment tool for pragmatic and discourse skills for patients suffering from schizophrenia .

The scientific literature has largely objectified language disorders in schizophrenia. And more precisely, the impairment of pragmatic and discursive language skills. Currently, there is no standardized language assessment tool specific to these patients. The aim of this study is to compare the effectiveness of a newly developed speech-language assessment tool for pragmatic and discourse skills for patients suffering from schizophrenia.

To do so, patients will have to pass six tests: three tests of the new tool and three corresponding gold standard tests. The first two tests will assess pragmatic skills by means of a semi-directed interview. The next two tests will assess discourse skills through two image description tasks. Finally, the last two tests will evaluate narrative skills through the oral restitution of two heard texts.

The main objective is to compare the performance of schizophrenic patients detected in the pathological zone with the scales of the new tool versus the gold standard scales.

The secondary objective is to determine which skills are most affected by comparing patients' scores in pragmatic skills versus those in discourse skills.

This tool would allow to precisely objectify language disorders and to optimize the multidisciplinary diagnosis and care of patients suffering from schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 18 and 60
* Patient with a diagnosis of schizophrenic spectrum disorder and other psychotic disorders meeting DSM V criteria
* Patient who has been clinically and treatment stable for at least three months
* Patient who can read and write French
* Patient who is a beneficiary of a social security plan or similar
* Patient with ability to sign free and informed consent

Exclusion Criteria:

* - Patient hospitalized under restraint
* Patient under guardianship
* Patient who has stopped taking his or her treatment
* Patient who had a change in treatment in the period of less than three months prior to the pass
* Patient with a worsening of the disease in the three months prior to the inclusion visit
Correlation Analysis of POD and pNCD in Elderly Spinal Surgery Patients

This study is a prospective cohort study to investigate the differences in serum indexes between elderly spinal surgery patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).

To investigate the differences in serum indexes between elderly spinal surgery patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).

Neurocognitive function of the study participants was assessed within one week before surgery using the Montreal Cognitive Assessment (MoCA). Compare changes in serum indexes level before and after surgery. Under routine anesthetic management of the Department of Anesthesiology and Surgical Operations at Xuanwu Hospital, endotracheal intubation general anesthesia was performed. Within 7 days post-surgery, delirium assessment was conducted using the Confusion Assessment Method (CAM), classifying patients into POD and non-POD groups. Neurocognitive function assessments were conducted long-term after surgery for the POD group to determine the presence of pNCD, further dividing the POD group into pNCD and non-pNCD subgroups, followed by serum indexes.By comparing the changes of serum indexes before and after surgery between the pNCD and non-pNCD subgroups, exploring the correlation of POD and pNCD.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥65 years of age who have undergone spinal surgery anesthesia; Sign informed consent

Exclusion Criteria:

* Inability to complete cognitive function assessment; Illiteracy, hearing impairment or visual impairment; He has a history of epilepsy, depression, schizophrenia, Alzheimer's disease and other psychiatric and neurological diseases
Comparative Study Between Levobupivacaine and Ropivacaine in the Hip Fractures of the Elderly

Prospective, low-level, non-commercial intervention, comparative clinical trial (phase IV) of balanced, randomized groups, to compare the analgesic efficacy of the local anesthetics Ropivacaine and Levobupivacaine in peripheral nerve block in hip fracture surgery in the elderly .

There are several studies that try to identify the ideal anesthetic for the management and control of pain in hip fracture surgery in the elderly. The optimum would be to use an anesthetic with the lowest possible latency, since this will favor the start of surgery. And, at the same time, with a more lasting analgesia with the least motor impairment. Therefore, it is essential to collect data on efficacy (effective block that allows us to mobilize the patient), latency, and analgesic scales appropriate to the cognitive state of the study sample.

Eligibility Criteria:
Inclusion Criteria:

* The patient will have to voluntarily sign and understand the informed consent that will be provided in writing.
* Patients over 65 years of age, with a hip fracture, who are going to be operated on at the Salamanca University Assistance Complex (CAUSA).

Exclusion Criteria:

* Rejection of the technique.
* Allergy to any of the drugs.
* Coagulation disorders.
* Local infections instead of puncture.
* Vascular prostheses at the femoral level.
Primary Renal Lymphoma on a 48 Year Old Woman

A 48-year-old female presented to our hospital with the following medical conditions: Systemic arterial hypertension in treatment. She denies any allergies or surgical history.

She reports a history of asthenia and adynamia for 3 months, accompanied by intermittent pain in the left flank. She denies hematuria, fever or weight loss. She underwent an enhanced CT examination at the local hospital, and a mass (10 x 9 cm in diameter) was noted in the left kidney.

She underwent radical nephrectomy and lymph node dissection. with the following surgical findings: (Figure 3) Kidney measuring 7 x 6 x 5 cm, with a tumor located in the upper pole of approximately 12 cm, with abundant newly formed vessels, loose and firm adhesions tumor-spleen and tail of pancreas, 1 artery, 1 vein, 1 ureter.

Postoperative pathology and inmunohistochemistry indicated DLBCL wich only localized in the kidney. Bone marrow biopsy and CT of the chest region dod not show any evidence of linmphoma invasion. According to the findings, she was diagnosed with PRL. After operation the patient received the R-CHOP regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patient with renal lymphoma

Exclusion Criteria:

* Patient without renal lymphoma
The Relationship Between XinKang-I and Chronic Heart Failure

Background: Heart failure is the severe and terminal stage of various heart diseases, which is characterized by high morbidity, mortality and readmission. There are few studies on the relationship between XinKang-I(XK-I) and chronic heart failure.

Objective: To explore the relationship between XK-I and chronic heart failure. Methods/design: The trial is a single-center, single-blind, randomized study (1:1). It will recruit 110 patients with chronic heart failure who syndrome of qi deficiency yang deficiency and blood stasis. The intervention group will receive not only Western medicine, but also XK-I. The primary end points will be the changes in oxygen consumption volume of anaerobic threshold (VO2AT), maximum oxygen volume uptake (VO2max), and 6-minute walking distance after 8 weeks of treatment. Both groups will receive 8 weeks of treatment.

Ethics and dissemination: Ethical approval was granted by Ethics Committee of Dongguan TCM Hospital. Results will be disseminated via peer-reviewed publications and presentations at international conferences.


Eligibility Criteria:
Inclusion Criteria:

1. History of CHF or clinical findings of CHF for more than 3 months. CHF was diagnosed in accordance with the European Society of Cardiology's 2021 Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure.
2. Patients ranged in age from 18 to 85.
3. Cardiac function was graded at grade II-IV (New York Heart Association functional class).
4. Patients who had not used traditional Chinese medicine for treating heart failure within 1 week before enrollment;
5. Written informed consent will be obtained.

Exclusion Criteria:

1. acute cardiac insufficiency, acute myocarditis, severe valvular heart disease, malignant arrhythmia, obstructive cardiomyopathy, pericardial tamponade, constrictive pericarditis or acute coronary syndrome
2. severe lung, liver or kidney dysfunction
3. nervous and hematopoietic system
4. malignant tumors
5. hemodynamic nstability
6. pulmonary embolism
7. severe infection
8. pregnant or lactating
9. refusal to provide written informed consent for this study
Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope

Band ligation and injection sclerotherapy are two modalities of treatment that are applied using the endoscope. The purpose of this study is to determine which of two methods is better for controlling bleeding from the upper gut.

The use of band ligation for endoscopy during the attack of hematemesis is a novel practice as opposed to injection sclerotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Active hematemesis
* esophageal varices

Exclusion Criteria:

* Hemodynamic unstability
* Hepatic coma or precoma
* Tense ascitis
* Coagulopathies
* concomitant gastric varices
Evaluation of Oxidative Stress and Effect of Levothyroxine Treatment on Oxidative Stress in Hashimoto Disease

Oxidative stress leads to or accompanies with numerous disease. Oxidative balance in subclinical hypothyroid or euthyroid state in Hashimoto disease are not known. Effect of levothyroxine therapy on oxidative balance are also not known in hashimoto disease.

oxidative stress markers will be measured initially(TAS,TOS,OSI,PARAOXONASE,ARYLESTERASA,PON1 PHENOTYPİNG,LİPİDPEROXİD).After 3 months therapy with levothyroxine measurements will be repeated except PON1 phenotyping.

Eligibility Criteria:
Inclusion Criteria:

* age more than 18 years

Exclusion Criteria:

* inability to give a written consent
* other conditions and drug usage affect oxidative stress
Chronic Life Stress and Incident Asthma in Adult Women

To prospectively examine the association between a specific chronic life stressor (i.e., intimate violence exposure) and adult asthma in women.

BACKGROUND:

Etiologies of the rising prevalence and morbidity of asthma are not well understood. Knowledge gaps are particularly significant with respect to adult-onset asthma. The role of stress in the expression of asthma is largely unexplored in large-scale, prospective, epidemiologic studies and such investigation has been identified as a priority by a recent NHLBI expert panel.

DESIGN NARRATIVE:

The study prospectively examines the association between a specific chronic life stressor (i.e., intimate violence exposure) and adult asthma in women participating in the Nurses' Health Study II cohort. Emerging epidemiologic data suggest that exposure to intimate violence is a pervasive chronic life stressor associated with adverse impact on womens' psychological and physical health. Traumatic stress such as that related to intimate violence exposure has been associated with neuroendocrine changes known to cause alterations in neuroendocrine and immune functions important to the pathophysiology of inflammatory diseases including asthma. The investigators are testing the hypothesis that women exposed to high-level chronic stress (violence) will be at greater risk for asthma development than women with low-level stress (violence) exposure. The influence of chronic stress on neuroendocrine and immune function as reflected in morning cortisol expression, for the former, and cytokine profiles and IgE production (T-helper cell polarization), for the latter, will also be examined in a nested case control fashion among these women.

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