cyrilzakka/clinical-trials huggingface dataset:
The Effects of Neuromuscular Electrical Stimulation in Individuals With Urinary Incontinence After Prostatectomy

The aim of this study is to investigate the effects of neuromuscular electric stimulation on urinary symptoms, quality of life, sexual function, perception of improvement and patient satisfaction in individuals with post-prostatectomy urinary incontinence

One of the two most common complications after prostatectomy surgeries is urinary incontinence (UI) and the other is erectile dysfunction. There are conservative and surgical treatment options in post-prostatectomy urinary incontinence. One of the conservative treatment options is neuromuscular electrical stimulation application. Since electrical stimulation applications, used in the treatment of post-prostatectomy urinary incontinence, are usually given together with other treatment protocols, there are limitations in clearly demonstrating the effects of neuromuscular electrical stimulation on post-prostatectomy urinary incontinence.

Eligibility Criteria:
Inclusion Criteria:

* Being a male individual with stress or stress-dominant mixed urinary incontinence symptoms after undergoing prostatectomy surgery in the urology clinic
* Being over 40 years old
* Volunteering to participate in the study

Exclusion Criteria:

* Severe cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients ect.)
* Those with sensory loss
* Presence of ongoing urinary infection
* Only urgency urinary incontinence
* Having a pacemaker
* Active cancer treatment (radiotherapy, chemotherapy),
* Those who have undergone Transurethral Prostatectomy (TUR-P) surgery
* Those who have a problem that interferes with cooperation and understanding
Phase 1, First-in-Human Study of RAD140 in Postmenopausal Women With Breast Cancer

The primary purpose of this study is to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast cancer.

This is a first in humans study that is designed to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast cancer.

Eligibility Criteria:
Key Inclusion Criteria:

* Progressive metastatic or locally advanced or metastatic breast cancer.
* Clinically confirmed as postmenopausal.
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 1 at screening.

Key Exclusion Criteria:

* HER2 positive patients by local laboratory testing.
* Triple negative breast cancer.
* Any chemotherapy within the 28 days prior to the first dose of study drug.
* Any non-chemotherapy anti-cancer drug less than 5 half-lives (30 days for biologics) or less than 14 days for small molecule therapeutics, or if half-life is not known.
* Tamoxifen and aromatase inhibitors within 14 days prior to the first dose of study drug.
* Fulvestrant within 30 days prior to first dose of study drug.
* Any investigational drug therapy within 5 half-lives of the previous investigational study drug or 30 days, whichever is shorter.
* Radiation therapy for breast cancer within 2 weeks of dosing and planning to have radiation therapy during participation in this study.
* Known history of human immunodeficiency virus infection (HIV) or hepatitis C or active hepatitis B infection, unless the patient was diagnosed \>10 years prior to enrollment and no evidence of active liver disease.
* Currently taking testosterone, methyltestosterone, oxandrolone (Oxandrin), oxymetholone, danazol, fluoxymesterone (Halotestin), or testosterone-like agents.
* Untreated or uncontrolled brain metastasis.
* Diagnosed with or treated for cancer within the previous 2 years, other than breast cancer or non-melanoma carcinoma of the skin.
* Pregnant and nursing females.
Detection and Pathogenesis of Novel Protein F

From December 6, 2019 to March 23, 2020, the research group of Qingkun Fan found a novel protein(temporarily named protein F) in heparin anticoagulant plasma of three patients with heart disease. One patient was diagnosed with multiple myeloma.However, protein F cannot be detected by serum protein electrophoresis. Preliminary studies have shown that this novel protein F have an obvious absorption peak at about 600nm. Placed at 2-8 degrees for 7 days, protein F will be isolated from heparin plasma. To the naked eye, protein F appear to be transparent jelly between the red blood cells and the plasma. The specific protein F, how it is produced, how it causes disease are still unknown. This study will explore how to detect protein F and how it is produced.

Protein F screening was performed on anticoagulant blood plasma with heparin Lithium or blood serum by in-house turbidimetric method in Automatic biochemical analyzer.

All patients were followed-up for 3 years by telephones, routine appointment out-patient clinic or returning visit.

Eligibility Criteria:
Inclusion Criteria:

* Testing total protein and albumin
* Testing routine blood test

Exclusion Criteria:

* high triglycerides (TG\>5.00 mmol/L)
* hyperbilirubinemia (TBIL\>170 mmol/L)
* fat emulsion used in past 3 days
* patients with hemolytic disease
* pregnant and lactating women
Study of BOTOX Injections to Assess Change in Disease Activity and Adverse Events in Adult Female Participants With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic and debilitating urological complex of disorders characterized by symptoms of bladder pain or discomfort, mostly upon bladder filling, and often accompanied by lower urinary tract symptoms (LUTS). This study will assess how safe and effective BOTOX (onabotulinumtoxinA) is in treating IC/BPS. Adverse events and change in disease symptoms will be evaluated.

BOTOX (onabotulinumtoxinA) is an investigational drug being developed for the treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Study doctors randomly assign the participants to 1 of 2 groups, called treatment arms, to receive BOTOX or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 80 female participants, aged 18 to 75 years, with a diagnosis of IC/BPS will be enrolled in approximately 40 sites in the United States and Canada.

Participants will receive BOTOX or placebo injected into the bladder on Day 1 and will be followed for at least 12 weeks in treatment 1. Eligible participants may request additional dose of BOTOX between Weeks 12 and 24, and will be followed for 12 weeks in treatment period 2.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

- Presence of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms for at least 6 months, diagnosed by the investigator as IC/BPS, and confirmed dominant bladder derived pain.

Exclusion Criteria:

- History or current diagnosis of Hunner Lesions.
Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Children

This study aims to evaluate the effectiveness of the Occupational Therapy Handwriting Interventions Guidelines (OTHIG) in enhancing handwriting performance among children.

Method:

Forty-two children recruited from private centers with occupational therapy indications and with handwriting issues, aged five to nine years, will be assigned to the experimental and control groups.

Participants will receive a total of 10-week sessions, including training, intervention, and outcome measures.

The experimental group will receive the developed OTHIG during handwriting skills intervention. Meanwhile, the control group will receive conventional interventions which not exposed to the OTHIG.

This study is expected to provide evidence for the effectiveness of using the developed OTHIG to OTs in delivering their services, targeting children struggling with handwriting skills.

The study is a Cluster Randomised Controlled Trial (C-RCT) that systematically clusters the centers into the treatment and control groups.

A total of 10 centers will be involved in this study.

The clustering of all ten centers will allocate randomly into the treatment and control groups based on submitting the consent letter to the researcher and after an assessment of TPT and TVPS-4 are conducted.

Ten early interventions have similar characteristics such as (1) hiring graduated occupational therapists from recognized universities in Malaysia, (2) having occupational therapists working daily at the centre, (3) having children aged five to nine years who receive OTs intervention.

This randomization will be allocated based on the list of the centers that give an early submission of a signed consent form. The randomization will be carried out with a mechanism that neither the researcher nor children or center owners will know which group of intervention they will be assigned.

Eligibility Criteria:
Inclusion Criteria:

* age between five and nine years
* engaged in OTs intervention either in an individual or group session.

Exclusion Criteria:

* refuse to participate in the study
* fail to comply with the whole intervention process during the study
* present severe sensory problems
* present poor behavior during intervention
Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures

This is a prospective, level II evidence comparison between two cohorts. This study is designed to compare the percutaneous versus open approach for plate fixation of diaphyseal clavicle fractures. This study includes questionnaires and measurements that will collect data on incision-related numbness, union rates, overall outcomes, complication rates of the two methods, infection rates, and overall satisfaction. The surgical procedure, all radiographs and follow-up visits to a minimum of one year are the principle investigators (PI's) standard of care for this injury. Measurements and questionnaires are related to the study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* displaced (i.e., no cortical contact of fracture ends on two xray view) diaphyseal clavicle fracture
* fracture pattern amenable to plate fixation
* neurologic injury requiring open reduction
* open clavicle fracture
* clavicle nonunion (defined as an absence of radiographic bony union in the presence of neurologic, cosmetic, or functional complaints at six months duration
* symptomatic malunion (defined as a healed, but shortened or angulated fracture in the presence of neurologic, cosmetic, or functional complaints)
* clavicle fracture associated with a scapular of humeral fracture (floating shoulder)

Exclusion Criteria:

* a nondisplaced or minimally displaced closed, neurovascularly intact clavicle fracture
* fracture of the medial or lateral end of the clavicle
* pathological fracture
* patient is unable to medically tolerate general anesthesia
* patient is unable to provide informed consent or comply with completing questionnaires
Oxycodone in Combination With Parathoracic Nerve Block is Used for Postoperative Analgesia in Lung Cancer

In this study, the effect of oxycodone combined with ultrasound-guided paravertebral nerve block on the postoperative analgesic effect of thoracoscopic lung cancer was investigated, and the effect and reasonable dose of oxycodone were explored, which provided a reference for the clinical multimodal analgesia after thoracoscopic lung cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age \> 60 years
2. Patients undergoing thoracoscopic lobectomy
3. ASA (American Academy of Anesthesiologists) Grades I-III
4. There were no obvious abnormalities in heart, liver, and kidney function
5. Sign the informed consent form for this clinical study

Exclusion Criteria:

1. History of oxycodone or sufentanil allergy
2. Renal or hepatic dysfunction
3. History of drug or alcohol abuse
4. Psychiatric disorders: schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis
5. Those who have difficulty communicating due to coma, severe dementia, speech barrier, or those who cannot cooperate due to other diseases.
6. People with head trauma or other brain diseases -
Efficacy of Topical Cyclosporine 0.05% in the Prevention of Ocular Surface Inflammation Secondary to Pterygia

To Determine if topical cyclosporine 0.05% BID prevents recurrent inflammation and improves comfort in eyes with pterygia.


Eligibility Criteria:
Inclusion Criteria:

* pts with symptomatic pterygia unresponsive to palliative treatment.
Examination of the Pressure Ulcers in Intensive Care Patients.

A pressure sore was localized skin and/or subcutaneous tissue injury, usually caused by pressure alone or a combination of shear and pressure, at bony prominences. Pressure sores, which are an indicator of the quality of health care, increase mortality, morbidity and cost. Pressure ulcers are the most common problem in intensive care patients and should be prevented. In the literature, the incidence of pressure ulcers in intensive care patients is between 1-59.9%.

A pressure sore is a localized injury to the skin and/or underlying soft tissue, usually over a bony prominence or associated with medical or other devices. This injury occurs when intense and/or prolonged pressure or pressure is accompanied by shear. Soft tissue tolerance to pressure and shear; temperature and humidity can affect nutrition, perfusion, concomitant conditions, and condition of soft tissue.

This study was carried out to determine the prevalence of pressure ulcers and influencing factors in patients hospitalized in the 3rd level intensive care unit of a university hospital.

Design: It is a descriptive, prospective, observational type study. Materials and Methods: The sample of the study consisted of 176 patients aged 18 years and above, 24 hours after hospitalization in the intensive care units of a University Hospital. Patient Information Form and Braden Scale for Predicting Pressure Ulcer Risk, Glasgow Coma Scale were used to collecting data. Statistical Package in statistical analysis for the social sciences 20.0 program was used.

Due to the renovation initiated in the intensive care units, the work was started in November 2019, but the working time was extended due to the Covid 19 pandemic that developed immediately after. The sample of the study consisted of patients who met the inclusion criteria and accepted participation, among the patients who were hospitalized on Wednesday, which was determined as the middle of each week, between November 2019 and February 2021 in the 3rd-level intensive care units of a university hospital.

Data Collection: "Personal Information Form" prepared by the researcher as a result of the literature review for data collection, "Braden Scale for Predicting Pressure Ulcer Risk" for evaluating pressure ulcers, "Glasgow Coma Score" for evaluating patient's consciousness status, and ulcer used by National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel staging classification was used.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* Hospitalized in the 3rd step intensive care unit
* Being hospitalized for at least 24 hours
* No pressure ulcers on the first hospitalization

Exclusion Criteria:

* hospitalization time not exceeding 24 hours
Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections

The aim of the study was to assess the effectiveness of a hand-washing programme using hand sanitizer in the prevention of school absenteeism due to upper respiratory infections. Students in intervention classrooms used hand sanitizers at schools and a programme educational on hand hygiene. The investigators hypothesize that the use de hand sanitizers in elementary school will reduce absenteeism due to upper respiratory infections.

School absenteeism due to respiratory infections is one of the greatest problems in schools. Its high incidence and easy transmission among pupils have a great impact requiring a vast number of medical visits, hospitalisations, use of antibiotic and antipyretic treatments, symptomatic medication, etc. besides being a cause for school absenteeism and time off work for parents. Hand- washing is the most important and effective measure to prevent the transmission of infections. The investigators evaluated the effectiveness of a hand-washing programme using hand sanitizer in the prevention of school absenteeism due to upper respiratory infections.

A cluster randomised, controlled and open study of 2 cohorts of primary school children between the ages of 4 and 12, attending 5 Public Schools in a geographic area of the Almería province (Spain). This study was carried out throughout the 8 months of an academic year (October 2009 to May 2010). The experimental group washed their hands with soap and water, complemented with hand sanitizer, while the control group followed usual hand washing. The parents of both groups completed the survey on sociodemographic characteristics and questions about hand hygiene referred to when and how their children wash their hands Progenitors of children who were absent from school collected upper respiratory infections symptoms and handed in the completed form to the teacher. One Research assistant collected the absence sheets of the participating classes weekly, telephoned the parents of absent children to enquire about the cause of their absence, visited the classrooms and collaborated with the teachers in hand hygiene related activities.

Eligibility Criteria:
Inclusion criteria:

* School children between the ages of 4 and 12 years old, enrolled in the above mentioned public schools,
* The parents/tutors signed an agreement after being informed of its content.

Exclusion criteria:

* Children with absenteeism due to a different cause from upper respiratory infections
* Children with chronic illnesses that could affect their likelihood of contracting an infection or the duration of their period of absence from school
* Children whose parents did not authorise their participation in the study.
Neuropeptide Y Regulates Neurogenic Pulp Inflammation

Objective. This study assessed the neuropeptide Y (NPY) expression in healthy human dental pulp following tooth bleaching with three in-office hydrogen peroxide-based systems: Opalescence Boost© (Ultradent Products, South Jordan, UT), Pola Office© (SDI, Victoria, Australia), and Zoom© (Zoom! Bleaching System; Discuss Dental, Culver City, CA).

Materials and Methods. Forty dental pulps were collected from healthy premolars scheduled for extraction for orthodontic reasons. Teeth were divided into four groups containing ten healthy premolars each: Control group (n= 10): the teeth were not exposed to dental bleaching agents (healthy pulps assessed for normal/basal NPY values). Pola Office system group (n= 10): application of Pola office (35% H2O2) for 8 minutes. Opalescent Boost system group (n= 10): application of Opalescent Boost (40% H2O2) for 20 minutes. Zoom system group (n= 10): application of Zoom! (25% H2O2 + cold blue light) for 15 minutes. The investigators rigorously followed the manufacturer's instructions for all bleaching systems. Following the extractions, the pulpal tissue was collected, placed in a 4% formaldehyde solution in Eppendorf tubes, and processed. NPY levels were measured using enzyme-linked immunosorbent assay (ELISA).


Eligibility Criteria:
Inclusion Criteria:

* Dental pulps were collected from non-smoking donors
* Patients who need premolar extractions for orthodontic purposes.
* These premolars must meet the following requirements:
* Caries and restoration-free,
* Complete root development (visually and radiographically confirmed),
* Normal response to sensitivity testing.

Exclusion Criteria:

* Evidence of periodontal disease,
* Traumatic occlusion
* Previous orthodontic force application.
Evaluation of the Technique LHP (Laser HemorrhoidoPlasty) in Haemorrhoidal Prolapse Mini Invasive Surgery

Hemorrhoids surgery technics evolved during the past 20 years. Recently a new one using laser have been developped. It aims at reducing the blood flow towards hemorroïdal plexuses by photocoagulating with a fiber laser the terminal branches of the superior rectal artery.

The aim is to evaluate the efficacy of this technic and note the post surgery pain and events


Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* hemorrhoid prolapse grade 2 and 3
* accepting participation

Exclusion Criteria:

* hemorrhoid prolapse grade 1 and 4
* other proctological pathology
* previous surgery of prolapsus
* with anti coagulant treatment
* Intestinal chronic inflammatory disease
* age \< 18
* pregnancy
Perioperative Analgesia Modes in Minimally Invasive Esophagectomy

This study was designed to compare analgesic efficacy and safety of different perioperative analgesic modes in minimally invasive esophagectomy for esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years;
* Patients underwent laparoscopic and thoracoscopic or robotic-assisted minimally invasive esophagectomy ;
* Informed consent.

Exclusion Criteria:

* Has a history of cholecystitis or urolithiasis within 3 months;
* Has a history of atherothrombosis (peripheral arterial disease), stroke, myocardial infarction;
* With lung diseases, such as pneumonia, atelectasis, emphysema, pulmonary bullae, etc;
* Preoperative cardiac function grade ≥ III or coronary artery stenosis;
* Preoperative indwelling of a thoracic drainage tube;
* Long-term heavy drinker(heavy drinking was defined as follows: for men, consuming more than 4 drinks on any day or more than 14 drinks per week; For women, consuming more than 3 drinks on any day or more than 7 drinks per week);
* Opioid-tolerant patients(defined as those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid);
* With painful skin complications, such as rashes and blisters;
* Conversion to open surgery;
* The postoperative ventilation function was limited, or the duration of endotracheal intubation was more than 24h.
Pleural Effusion Following Cardiac Surgery: Prevalence, Risk Factors and Clinical Features

Pleural effusion is a common complication of cardiac surgery. The aim of this study was to determine the prevalence, characteristics and determinants of clinically significant pleural effusions, defined as those requiring therapeutic pleural drainage.

This was a retrospective cohort study of prevalence and characteristics of patients who had a pleural effusion after coronary artery bypass graft, valve replacement or both procedures.

Information was collected on all consecutive patients who underwent CABG surgery and/or valve replacement between January 1, 2004 and December 31, 2005. Demographic information, anthropometric parameters, cardiac and renal function assessments, and comorbid conditions were retrieved from medical files. We also collected data on the type of procedure, whether it was elective or urgent, the number and origin of the grafts, the duration of surgery and of cardiopulmonary bypass and the postoperative complications, including pleural effusions. Clinical presentation and evolution of the effusions as well as pleural fluid characteristics were also studied.

Patients were considered to have a clinically significant pleural effusion when they met at least one of the following criteria: need for thoracentesis, a pleural drainage tube or a hospital readmission due to a pleural effusion that occurred within one year of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery bypass grafting (CABG)
* Valve replacement
* Combined CABG and valve replacement
* between January 1st, 2004 and December 31st, 2005

Exclusion Criteria:

* Previous CABG
* Pulmonary and/or aortic artery surgery
* Heart or lung transplant
* Pleural effusion present at the time of surgery