cyrilzakka/clinical-trials huggingface dataset:
Behavioral Intervention Program and Vaginal Cones on SUI

This study is a single blind randomized clinical trial to compare the efficacy of a behavioral intervention program versus vaginal cones on Stress Urinary Incontinence (SUI).

Detailed Description: In this single-blind randomized clinical trial, 60 women aged 25-65 yrs with stress urinary incontinence were randomly divided in two groups by blocked randomization method; behavioral intervention program (n=30) and insertion vaginal device,vaginal cones (n=30). Women in behavioral intervention group were instructed for pelvic floor exercise and bladder control strategies. Other group was allocated to use vaginal cones. They were treated for 12 weeks and followed up every 2 weeks. The subjective changes in severity of SUI were measured using a Detection SUI Severity Questionnaire and leakage index and 3-day urinary dairy. The objective changes were measured by pad test. These two groups were then compared according to the scores of special questionnaires for quality of life, strength of pelvic floor muscles, capability to participate in social activities, severity of urinary incontinence, and the number of involuntary urine passage, taken before, and after 1 and 3 months after finishing interventions. Data analysis will be done through descriptive and perceptive statistical methods by using SPSS.

Eligibility Criteria:
Inclusion Criteria:

* symptoms of SUI , at least three episodes of stress incontinence per week
* Age 25-65
* body mass index (BMI) ≤ 30 kg/m2
* physical health

Exclusion Criteria:

* chronic degenerative diseases affected on muscular and nerve tissues
* vulvovaginitis, atrophic vaginitis,
* pregnancy
* active or recurrent urinary tract infections
* advanced genital prolepses
* patients with cardiac pacemakers
Determinants of Glycaemic Control in Children With Type 1 Diabetes

Type 1 diabetes (T1D) is a common chronic disease of childhood associated with a significantly increased risk of micro- and macro-vascular complications, including neuropathy, nephropathy and cardiovascular diseases. The risk of development T1D comorbidities is associated with glycaemic control, a complex mechanism involving biological, physiological environmental factors.

While more than 60 genetic variants were already associated with Glycated hemoglobin (HbA1c) in healthy subjects, very few genes have been identified in T1D individuals. Also, hyperglycaemia could be the cause of epigenetic changes at specific target genes, such as DNA methylation, histone modifications and microRNAs, correlated to accelerated development of diabetes-related complications. Most recently, increasing evidence also suggested that human microbiome may play a crucial role in the onset and progression of T1D and dysbiosis of the gut and oral microbiota was reported as a typical feature of hyperglycaemia.

However, potential differences among poorly and good managed T1D subjects have not been still studied. Also, the exact mechanism by long-term hyperglycaemia's acts in T1D remains poorly understood. Therefore, this project will explore an emerging area of research by the study of possible genetic, epigenetic and environmental biomarkers among T1D subjects with different glycaemic control.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes subjects
* Age from 6 to 20 years old
* At least 5 years of duration of disease

Exclusion Criteria:

* Type 1 diabetes subjects incapable of giving valid informed consent or whose parents are incapable of giving valid informed consent.
* Type 1 diabetes subjects for whom it is not possible to collect information on the clinical history, starting from the onset of diabetes
* Subjects with other types of diabetes (i.e. type 2, monogenic diabetes, cystic fibrosis related diabetes)
Coffee After Pancreatic Surgery

Postoperative ileus is a common complication after major abdominal surgery. A positive effect of coffee to bowel movement has been described after colorectal and gynecologic interventions. The objective of this randomised controlled trial is to investigate whether the implementation of a fast track protocol with early coffee consumption accelerates the recovery of bowel function after pancreaticoduodenectomy.

Postoperative ileus (POI) is a common disorder after major abdominal surgery, affecting up to 40% of patients undergoing laparotomy. POI is described as the time between surgery and the first passage of flatus and/or stool and tolerance of oral diet. It could be recognised as postoperative complication when is defined as two or more of nausea/vomiting, inability to tolerate oral diet over 24 h, absence of flatus over 24 h, abdominal distention and radiologic confirmation on or after day 4 postoperatively without prior resolution. Multimodal approaches have been described to treat POI; among them, the early consumption of coffee showed a substantial benefit after colorectal and gynecologic surgery. The objective of this randomised placebo-controlled trial is to investigate whether early coffee consumption can accelerate the recovery of bowel function after open pancreaticoduodenectomy.

Eligibility Criteria:
Inclusion Criteria:

* Elective open pancreaticoduodenectomy
* Age ≥ 18 years
* American Society Anesthesiologists (ASA) score ≤ 3
* Ability of the subject to understand aims and clinical consequences of the trial
* Written informed consent

Exclusion Criteria:

* American Society Anesthesiologists (ASA) score ≥ 4
* Need for early postoperative Intensive Care Unit care
* Need for naso-gastric tube on postoperative day one
* Intolerance to coffee
* Refuse to assume coffee
* Pregnancy
* Surgical procedures performed different from pancreaticoduodenectomy
* Impaired mental status or language problems
Exploring the Potential of Novel Biomarkers Based on Plasma microRNAs for a Better Management of Pelvic Gynecologic Tumors

This trial is a non-randomized, open label and multicenter study.

It aims to :

for endometrial cancer.:validate the 5-miR index assessed in plasma samples as a diagnostic marker to assess the risk of lymph node metastases for ovarian cancer : to validate the previous finding on the prognostic value of the pre-/post-treatment variation of miR200b plasma concentrations with regards to PFS (the investigators mean the primary treatment including up-front or post-chemotherapy debulking and adjuvant chemotherapy).

MicroRNAs (miRs) have been linked to carcinogenesis and can act as metastatic activators or suppressors. There is now ample evidence that circulating miRs can be used as biomarkers. This project is focused on ovarian (OC) and endometrial cancers (EC), respectively the deadliest and most frequent gynecologic malignancies.

The main challenge for physicians managing women with early-stage EC is when to opt for lymphadenectomy. Tools that are currently used are not accurate enough to identify women with increased risk of nodal metastases. Ballester's team recently found a relationship between the high expression of a set of 5 miRs in the primary tumor and nodal status.

OC is the leading cause of death from gynecological cancer. The prognosis depends on the response of the residual tumor mass to adjuvant chemotherapy. Currently, this response remains largely unpredictable and even difficult to monitor with CA125 measurements and current imaging techniques. Busson's team recently showed that the variation of plasma miR200b during primary treatment is predictive of progression-free survival (PFS).

The study involves 3 populations of participants :

* Patients with EC
* Patients with OC
* Patients undergoing surgery for benign pelvic lesions (control population)

Eligibility Criteria:
Inclusion Criteria:

For all patients (EC, OC, Control)

* Written informed consent;
* Age ≥ 18 years old;
* Patient affiliated to social security.

EC patients

* Histologically proven EC ;
* Type 1 and 2 EC;
* FIGO stage I or II or III EC requiring first intention surgical staging.

OC patients

* Histologically proven OC or strong suspicion of OC on clinical arguments (abdomino-pelvian mass detected by palpation or echography and/or ascitis and/or elevated CA125);
* Epithelial OC: any histological subtype;
* FIGO stage I to IV OC.

Control patients - Any lesion which is supposed to be benign and requires surgery. -

Exclusion Criteria:

For all patients (OC, EC, Control)

* Unable or unwilling to comply with the protocol requirements and/or unwilling to sign an informed consent form.
* Deprived of liberty or under legal protection measure;
* Ongoing pregnancy;

Control patients:

- Previous history of cancer.

EC patients

* FIGO stage IV at preoperative imaging techniques.
* Previous history of cancer. OC patients
* Non epithelial cancer.
* Previous history of cancer - except for patients who developed breast cancer at least 5 years or more before ovarian cancer.
Plasmalyte-148 Solution and Blood Coagulation

Fluids administered intravenously may alter whole blood coagulation. However, little is known about the dose-response relationships of hemodilution in plasmalyte-148 solution. Investigators have therefore performed the present study to measure the effect of a plasmalyte-148 solution on the coagulation pathway according to the hemodilution level using a rotational thromboelastometry (ROTEM®) tests.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age: 20 to 65 years
* Body weight \> 50 kg
* Volunteers who provided informed consent

Exclusion Criteria:

* Hematologic disease
* Anticoagulant medication
TCR-T Cell Immunotherapy of Lung Cancer and Other Solid Tumors

Tumor organoids and TILs (and/or peripheral T cells) cultures will be established from fresh tissure of lung cancer and other solid tumors. Coculture will be utilized to screen tumor-responsive T cells which are further selected for monoclonal expansion and TCR cloning for engineered reconstitution of TCR-T cells. After verification by multiple in vitro and in vivo studies, a large number of TCR-T cells will be introduced back into the patients via vein, artery or fine needle punctured to the tumor, or combinations. In this phase I study, the safety, tolerance and preliminary efficacy of the TCR-T cell immunotherapy on human will firstly be assessed.

1. Choose appropriate patients with KK-LC-1 expression in advanced lung cancer or other solid tumors and matched MHC-A11 typing, with written consent for this study; For cancer without expression of KK-LC-1, fresh tumor tissue should be obtained for RNA/DNA sequencing to computationally identify neoantigen peptides that can be captured by specifically personizedly synthesized poly-MHCI which can be further used to fish appropriate T cells from the patient.
2. Perform biopsy to obtain tissue from tumor/lymph node for organoids, TILs, DC and T cells culture, coculture to screening anti-tumor T cells, establish and select monoclonal T cells for TCR cloning;
3. Clone TCR sequence that targets KK-LC-1 or neoantigens; collect PBMCs from the blood of the patients, isolate and activate the T cells and generate the TCR-T cells;
4. Test the quality and killing activity of the TCR-T cells in vitro and then transplant back the patients via systemic (vein and/or artery) or local injections, and follow up closely to collect related clinical data as needed;
5. Evaluate the clinical results as needed.

Eligibility Criteria:
Inclusion Criteria:

1. patients with advanced lung tumor or other solid tumor where biopsy is obtainable
2. Life expectancy \>12 weeks
3. Child-Pugh-Turcotte score \<7
4. Adequate heart,lung,liver,kidney function
5. Available autologous transduced T cells with greater than or equal to 20% expression of targeted TCR sequences determined by flow-cytometry and killing of tumor cells greater than or equal to 20% in cytotoxicity assay
6. Informed consent explained to, understood by and signed by patient/ guardian. Patient/guardian given copy of informed consent. -

Exclusion Criteria:

1. Had accepted gene therapy before;
2. Tumor size more than 25cm;
3. Severe virus infection such as HBV, HCV, HIV, et al
4. Known HIV positivity
5. History of lung transplantation
6. Active infectious disease related to bacteria, virus,fungi,et al
7. Other severe diseases that the investigators consider not appropriate;
8. Pregnant or lactating women
9. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
10. Other conditions that the investigators consider not appropriate.
Antibiotic Prophylaxis for Bladder Botox

Injection of Botox into the bladder is a common treatment for overactive bladder. Postoperative bladder infection is one of the more frequently reported complications of this procedure. Prophylactic antibiotics given at the time of bladder Botox for the reduction of postoperative bladder infection have not been well studied. The main goal of our study is to determine if prophylactic antibiotics at the time of bladder Botox injection for the treatment of overactive bladder in women reduces postoperative bladder infection. The investigators are proposing a study which will randomize participants into two groups - one receiving Ciprofloxacin and the other receiving placebo pills for three days following the procedure. The primary outcome evaluated will be the difference in postoperative bladder infection between the two groups. The investigators will also investigate differences in reported side effects between the two groups possibly related to antibiotic use. Follow-up will be over six weeks following the procedure.

This study will be a single-centred, double-blinded, randomized, placebo-controlled trial. Recruitment will be undertaken at two Urogynecology/Urology sites associated with the University of Alberta in Edmonton, Alberta. Participants will be randomized to treatment or placebo arm with a 1:1 allocation ratio. Patients and surgeons will be blinded.

On the day of the procedure, a urine culture will be collected preoperatively to identify pre-existing bacteriuria. Technique and dose of Botox injection will be at the discretion of the operating physician. Trigone-sparing technique with injection of 100 to 200 units of Botox distributed across 10 to 20 sites is generally used at our centre.

Follow-up will occur over a six-week postoperative period. A questionnaire will be used at each follow-up encounter to screen patients for urinary tract infection symptoms, voiding dysfunction, and other adverse events potentially related to the prophylactic antibiotics. Urine cultures will be collected to confirm infection for patients developing postoperative symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic OAB diagnosed clinically who have failed medical management
* Female
* Age ≥ 18

Exclusion Criteria:

* Patients with neurogenic OAB (OAB with potential underlying neurologic cause - multiple sclerosis, spinal cord injury, Parkinson's disease, other)
* Contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, current urinary tract infection, symptomatic urinary retention or PVR \> 200 mL, unwillingness or inability to initiate CIC post-treatment if required.
* Contraindication to oral Ciprofloxacin - hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine.14
* Active antibiotic therapy for any indication at the time of Botox injection - increased risk of adverse reaction with combining antibiotics, reduced risk of UTI with additional antibiotic.
* Male
* Age \< 18
* Pregnant and/or breastfeeding
Dysphagia and VFMI in Cardiac Patients

The proposed study seeks to determine the incidence of dysphagia and vocal fold mobility impairment (VFMI) in individuals undergoing cardiothoracic surgical procedures. It also seeks to determine the impact of postoperative swallowing impairment on health-related outcomes.

Swallowing impairment and VFMI are common, yet often overlooked, complications of cardiac surgical procedures. The true incidence of both dysphagia and VFMI in this patient population is unclear due to a lack of rigorous study using instrumental assessment techniques and validated outcomes in all patents undergoing cardiac surgery. We therefore aimed to determine the incidence of dysphagia and VFMI in this patient population and to characterize impairment profiles related to swallowing safety and efficiency. We also aimed to assess the relative impact of VFMI and dysphagia on health-related outcomes such as length of hospital stay, pneumonia, sepsis, reintubation, and discharge status.

Eligibility Criteria:
Inclusion Criteria:

* adults aged 18 - 90 years old
* undergoing planned or emergent cardiothoracic surgery via sternotomy and/or extended thoracotomy requiring cardiopulmonary bypass
* willing to participate in post-operative swallowing evaluation testing

Exclusion Criteria:

* Patients undergoing exclusively transcatheter valves
* Patients undergoing exclusively thoracic endovascular aortic repair procedures
* The inability to achieve appropriate alertness and cognitive status following procedure will exclude one from completing the study.
* Participants must pass cognition, respiratory and physical abilities screening to ensure testing safety.
Turn up the HEAT - Healthy Eating and Activity Time in Summer Day Camps

The investigators long-term goal is to increase the number of Summer Day Camps (SDC) that meet the National Afterschool Association Healthy Eating and Physical Activity (HEPA) Standards. The objective is to evaluate the effectiveness of a multi-component intervention designed to increase children's PA levels and improve the quality of lunches and snacks children consume in SDCs. The HEPA intervention is designed to target children, parents, staff, program leaders, and the SDC environment and uses a train-the-trainer model with SDC leaders to train their staff to deliver and integrate the intervention into routine practice. In the proposed study, the investigators will evaluate these HEPA strategies, using a 4-year randomized controlled trial with 20 SDCs. An important feature of the study will be the evaluation of maintenance of the intervention after the removal of research support (e.g., training, boosters) during the final year, as well as costs associated with implementation.

The investigators hypothesize that intervention SDCs will achieve significantly greater increases in HEPA, compared to control SDCs. The investigators expect the study to support the cost-effectiveness and maintenance of our strategies for promoting HEPA that will facilitate SDCs meeting newly-established HEPA standards for this setting.

The investigators aim to:

Evaluate the impact of the HEPA interventions on: 1.) The proportion of children meeting the PA Standard (i.e., ≥60min MVPA/d) while attending summer day camp; 2.) The proportion of foods (e.g., fruit, vegetable, water) children and staff bring and consume at the summer day camp that meet the HE Standards; and 3/) Changes in children's age-sex specific BMI percentile from the start to end of summer

Evaluate the cost-effectiveness of the HEPA intervention

Evaluate the maintenance of the HEPA intervention in summer day camps

Eligibility Criteria:
Inclusion Criteria:

* Summer Day camps will be eligible if:
* They operate for at least 10 weeks during the summer
* They do not have any primary focus such as sports, art, or tutoring (must be a general camp)
* Enrollment is at least 40 campers
* Operation hours are at least 8 hours.

Exclusion Criteria:

* Children will be unable to wear an activity monitor if experience any physical and/or orthopedic impairment that limits the child's ability to participate in regular PA (e.g., wheelchair user)
The Relationship Between Lower Limb Functionality, Foot Joint Position Sensation and Balance in Haemiplegic Patients

Stroke is defined as a neurological disorder resulting from acute focal damage to the central nervous system caused by vascular factors, which may include cerebral infarction, intracerebral haemorrhage and subarachnoid haemorrhage. Postural balance is a critical factor affecting walking and gait performance in the community after stroke. Gait disorders contribute significantly to functional disability in individuals after stroke. These impairments encompass a variety of changes, including muscle weakness in the affected lower limb, resulting in reduced weight bearing on that limb. This results in a slower and less safe gait. Given the impact on gait, functional mobility is also compromised, including daily activities such as sitting, standing, walking, turning and climbing or descending stairs. Proprioception is impaired in a large percentage of individuals following stroke. The presence of proprioception deficits has been identified as an important determinant of unfavourable functional outcomes after stroke, especially in terms of achieving independence in basic activities of daily living and length of hospital stay. In the literature, there are no studies investigating the relationship between ankle position sense and lower extremity functionality with balance and falls using Humac Norm Isokinetic Machine and Tecno Body Prokin Isokinetic Balance System simultaneously.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 40-80 years
* Volunteering to participate in the study

Exclusion Criteria:

* Being diagnosed with vertigo
* Having a history of serious neurological diseases such as Parkinson's disease, multiple sclerosis except hemiplegia
* Having a previous operation for the lower limb
* Poor co-operation
A Study of CSL112 in Adults With Moderate Renal Impairment and Acute Myocardial Infarction

This study is a phase 2, multicenter, double-blind, randomized, placebo controlled, parallel-group study to investigate the renal safety and tolerability of multiple dose intravenous (IV) administration of CSL112 compared with placebo in subjects with moderate renal impairment (RI) and acute myocardial infarction (AMI).


Eligibility Criteria:
Inclusion Criteria:

• Men or women, at least 18 years of age, with evidence of moderate renal impairment (an eGFR ≥ 30 and \<60 mL/min/1.73 m2) and myocardial necrosis in a clinical setting consistent with a type I (spontaneous) acute myocardial infarction (AMI).

Exclusion Criteria:

* Symptoms, biomarker elevation or electrocardiogram (ECG) changes other than those of the index event that are consistent with a diagnosis of AMI but are likely not due to primary myocardial ischemia
* Ongoing hemodynamic instability
* Planned coronary artery bypass surgery
* Evidence of hepatobiliary disease
* History of acute kidney injury (AKI) after previous exposure to an intravenous contrast agent.
* History of nephrotic range proteinuria.
* Known history of allergy to soy beans or peanuts, immunoglobulin A (IgA) deficiency, antibodies to IgA , or hypersensitivity to CSL112 or any of its components.
* Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study.