cyrilzakka/clinical-trials huggingface dataset:
Preoperative Intervention to Reduce Delirium After Cardiac Surgery

This research is designed for experimental quantitative research and is conducted by simple random sampling. Both the control group and the experimental group provided preoperative routine nursing treatment and preoperative medical teaching manuals. The latter adds cognitive therapy and gamification evaluation. Both groups used CAM-ICU to assess the occurrence and duration of postoperative delirium, and DRS-R-98 was used to assess the severity of delirium. After collection, use SPSS 22.0 statistical software package for analysis and processing. The expected result is that the incidence of delirium, the duration of delirium, and the severity of delirium in the experimental group were significantly lower than those in the control group.

This study is an experimental quantitative research design. Both the control group and the experimental group provide routine nursing treatment and preoperative medical teaching manuals before surgery. The latter adds cognitive therapy and gamification evaluation of "Postoperative Care and Environmental Image Data Explanation". The two groups used CAM-ICU to assess the occurrence and duration of delirium after surgery, and DRS-R-98 was used to assess the severity of delirium. From 2021 to 2022, a simple random sampling method is adopted for patients undergoing cardiac surgery in the intensive care unit of a medical center in Central Taiwan, and a lottery is drawn on the first day of each month to determine the belong to which group in the current month. There were 55 persons in each group, and all subjects had no cognitive impairment. After the collected, it was analyzed and processed with SPSS 22.0 statistical package software.

Expected results: The incidence of delirium, the duration of delirium, and the severity of delirium in the experimental group were significantly lower than the control group.

Eligibility Criteria:
Inclusion Criteria:

* Expected to undergo traditional thoracotomy or minimally invasive surgery for cardiac surgery.
* No cognitive impairment before surgery.

Exclusion Criteria:

* Diagnosed with aortic dissection.
* Previously admitted to the intensive care unit.
Development and Validation of a New Paediatric Inflammatory Bowel Disease NUTrition Risk Score (PIBD-NUTS)

Children with inflammatory bowel disease (IBD) including both Crohn's disease (CD) and ulcerative colitis (UC) can be at high risk of developing malnutrition due to the nature of their condition. It is also believed that some children with IBD, in need of nutritional care, are not identified quickly by their healthcare professionals. This may negatively affect their nutrition, disease progression and general well-being. Hence, it has been proposed that nutritional screening tools or scores (NSTs) should be used to promptly identify children needing further dietetic review and input. Although there are a few NSTs for generic use in sick children at hospital admission, NSTs or scores to use for children with IBD are currently missing. In this study, we would like to test the performance of an existing tool that is routinely used for all sick children at hospital admission (The Paediatric Yorkhill Malnutrition Score or PYMS)(5) and test whether PYMS can detect children with IBD who are at risk of malnutrition. If PYMS doesn't work well, we will develop a specific tool for children with IBD (The Paediatric IBD Nutrition Score or PIBD-NUTS).


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with either Crohn's disease or ulcerative colitis between the ages of (4-18 years)

Exclusion Criteria:

* Pediatric patients with IBDU
Standard Deviation of the Distance Between the Sural Nerve and Achilles Tendon by Ultrasound

The purpose of this study is to define the standardization of the distance between the Sural nerve \& Achilles tendon, in otherwise healthy persons and athletes.

The distance between the two anatomic structures is measured by US and data is analyzed to define the standardized distance in the population in order to avoid damage to the sural nerve while repairing an Achilles tendon rupture using the percutaneous methode.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* age 18-60

Exclusion Criteria:

* known bone or muscle disease
* major trauma to the leg or ankle in present or past
* surgery of leg or ankle in the past
* mental disabilities
Investigation of the Perceptual and Acoustic Voice in Trans Man

The aim of the study is to follow acoustic and perceptual voice changes in trans men during hormone therapy and to examine the relationship between psychosocial and vocal characteristics and testosterone measured in routine follow-up in accordance with international follow-up guidelines.

Trans men who have completed the evaluation and follow-up procedure and decided to use sex hormones will be included in the study. Participants will be followed for 8 doses of sex hormone use. Acoustic and perceptual changes in voice will be monitored at baseline (before hormone use), 4th dose, and 8th dose. The relationship between testosterone and psychosocial and vocal characteristics will be examined. At the baseline of the study, participants will be evaluated with Videolaryngostroboscopy (VLS). As a result of VLS, perceptual and acoustic voice evaluation will be made to the participants who are determined to have healthy vocal folds. During routine psychiatric visits, participants will be asked to fill in self-report scales. Endocrinological routine evaluations will be applied to the participants and the data of these routine evaluations will be used in the study. All of these evaluations (perceptual and acoustic voice evaluation, endocrinological and psychiatric evaluations) will be repeated at the 4. and 8. doses of the hormone therapy, except for the VLS evaluation.

IBM SPSS Statistics 26.0 and Microsoft Excel 365 programs will be used for statistical analysis. The number of participants to be included in the study was calculated using the G Power 3.1 program. In the analysis, the number of participants was determined as 28 (G power=0.80, α =0.05). The normal distribution of the data will be examined by visual and analytical methods (Shapiro-Wilk test, Kolmogorov-Smirnov test).The analysis of each variable measured at three time points will be evaluated using ANOVA if the assumptions of parametric tests are met, and using the Friedman test if the assumptions of parametric tests are not met. When the parametric conditions are met Paired t test will be used to compare the measurement values, and when the parametric conditions are not met, the Wilcoxon signed-rank test will be used. Multiple Regression Analysis will be used to determine the factors affecting the person's own perception of voince. Finally, statistical significance level was accepted as p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with "Gender Dysphoria" according to DSM 5
* Having decided to start hormone therapy

Exclusion Criteria:

* Diagnosis of vocal fold lesion in videolaryngostroboscopy evaluation
* Having previously received voice therapy or undergone voice surgery
* Having a systematic/or neurological disorder that may affect voice quality
* Having had hormone therapy or still on hormone therapy
Agreement and Precision Study of UNITY® DX and a Comparator Biometer

The purpose of this study is to validate the clinical measurement performance of an investigational biometer. Subjects will undergo multiple measurements of the eye, and the agreement, repeatability, and reproducibility of the biometric measurements will be evaluated.

This is intended to be a 1-visit study approximately 3 hours in length with planned duration of exposure of up to 20 minutes per device (investigational biometer and IOLMaster 700). Four cohorts will be enrolled. One eye per subject will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign an Institution Review Board approved Informed Consent form.
* Willing and able to attend all scheduled study visits as required by the protocol.
* Identified by the investigator as eligible for at least one of the 4 eye groups identified in the protocol.

Exclusion Criteria:

* Unable to fixate, for example, due to nystagmus or other eye movement abnormality.
* Any ocular disease and/or condition that, in the investigator's clinical judgment, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study.
* Active ocular infection or inflammation.
* Rigid or contact lens wear during the previous two weeks prior to Screening.
A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.

The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).


Eligibility Criteria:
Inclusion Criteria:

* History of erectile dysfunction (ED).
* Have had satisfactory response to tadalafil, sildenafil citrate, or vardenafil HCl for a period of at least 6 months and expect frequent use (at least one dose per week, on average) when administered as needed.
* Have never used tadalafil 5 mg or 2.5 mg once a day therapy.
* Anticipate having the same adult female sexual partner willing to participate during the study.
* Agree to make at least four sexual intercourse attempts during the first four weeks of the study.
* Agree not to use any other treatment for ED (even herbal treatments) during the study.
* Agree to follow the directions given by the study doctor and staff about using the study drug.

Exclusion Criteria:

* Have any other primary sexual disorders present or penile deformity.
* Have history of radical prostatectomy or penile implant.
* Have problems with your kidneys, liver, or nervous system.
* Have uncontrolled diabetes, as measured by a blood test for haemoglobin A1C greater than a value of 11%.
* Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin).
* Have chest pain (called unstable angina or angina) that requires treatment.
* Have heart disease that causes symptoms after you exert yourself.
* Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
* Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION).
* Have retinitis pigmentosa.
* Have history of human immunodeficiency virus (HIV).
* Have very high or very low blood pressure (your study doctor will discuss the limits with you).
* Have had a stroke or a significant injury to your brain or spinal cord within the last 6 months.
* Have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Lactose intolerance.
* Have a scheduled or planned surgery requiring anaesthesia during the course of the study.
* Have a scheduled cataract surgery during the curse of the study.
Randomized Controlled Trial of Community-based Nutritional, Physical and Cognitive Training Intervention Programmes for At Risk Frail Elderly

The aims of this proposed community-based randomized controlled trial are to evaluate the effectiveness of nutritional, physical exercise and cognitive training interventions for at-risk and frail elderly, to elucidate the biological determinants and changes associated with frailty, and to develop, evaluate and demonstrate the feasibility of screening instruments for frailty.

Community-living elderly persons are screened and 250 participants satisfying rigorous criteria for frailty are randomized to received nutritional, physical training, cognitive training, combined or control arms for 24 weeks and followed up for 12 months. Baseline evaluations will include an extensive range of potential markers of frailty and outcome measures, including functional disability and hospitalizations.

Frail subjects who were selected for the interventional trial (N=250) are followed up at 3, 6 and 12 months after baseline assessment. Non-trial subjects (about 2750) are followed up at 1 year after baseline assessment

Eligibility Criteria:
Inclusion Criteria:

1. Age of 65 years or older
2. Living at home
3. Able to walk without personal assistance and no other physical limitations that can limit participation and adherence, particularly to exercise intervention programme
4. Meet criteria for frailty

Operational definition of frailty.

The participants are assessed and classified on the level of frailty by the following measures and criteria:

1. Weight loss
2. Slowness
3. Poor balance and weakness assessed by chair stand test
4. Muscle weakness assessed by hand grip and knee extension strength
5. Exhaustion, fatigue or low endurance
6. Low physical activity

Exclusion Criteria:

1. Member of household already enrolled
2. Dementia or cognitive impairment, major depression or other psychotic disorders
3. Severe audio-visual impairment
4. Progressive, degenerative neurologic disease like Parkinsonism, fits/ epilepsy, etc
5. Rapidly progressive or terminal illness under palliative care with life expectancy less than 12 months
6. History of alcohol abuse or any other substance abuse
7. Severely affect muscle/joint dysfunction resulting in disability
8. Hospital admission in the past 3 months
9. Regular physical training or physiotherapy or current participation in a vigorous exercise or weight-training program more than once per week
10. Undergoing therapeutic diet incompatible with nutritional supplementation
11. In the opinion of research clinician, the intervention is deemed to be potentially hazardous for the subject, such as serious cardiac and pulmonary disease.
Limb Loss Self-Management Program

The goal of the project is to develop and test the efficacy of a community-based self-management intervention for reducing pain, depression, and improving self-efficacy and function in person with limb loss

Approximately 1.2 million Americans are living with the loss of a limb and the incidence is increasing due to increases in the prevalence of diabetes. Pain, emotional distress, reduced functional abilities are common conditions following limb loss and reduce quality of life. Self-management interventions have been found to be effective in reducing the secondary conditions associated with arthritis and diabetes. Self management uses the principles of cognitive-behavioral therapy including education, self monitoring, problem solving, and skill acquisition.

The goal of the project is to develop and test the efficacy of a community based self management intervention for reducing pain, depression, and improving self efficacy and function in persons with limb loss using a randomized controlled design.

50 groups of 8-10 persons will be randomized to either a control group or a treatment group.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older congenital or acquired limb loss

Exclusion Criteria:

-
Ciclosporin in the Management of New Type 1 Reactions in Leprosy

Study 1A: Ciclosporin in the management of new Type 1 Reactions in Leprosy

Objective: A randomised double blind controlled trial comparing Ciclosporin and Prednisolone,to determine whether treatment with Ciclosporin gives the same outcome in the treatment of new Type 1 Reactions as Prednisolone.

We tested our hypothesis that ciclosporin would be as effective as prednisolone in the treatment of patients with leprosy reactions and nerve function impairment and that patients treated with ciclosporin would have fewer side effects than patients treated with prednisolone. A randomised controlled trial comparing ciclosporin and prednisolone in the treatment of acute leprosy T1R was conducted.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with clinical evidence of T1R with new nerve function impairment (NFI).
* Aged 18-65
* Weigh more than 30Kg

Exclusion Criteria:

* Unwillingness to give informed consent
* Patients with severe active infections such as tuberculosis
* Pregnant or breastfeeding women (see Appendix II)
* Those with renal failure, abnormal renal function, hypertensive
* Patients taking thalidomide currently or within the last 3 months
* Patients not willing to return for follow-up
* Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)
* HIV positive patients
The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation

The aim of this study is to evaluate the effectiveness and safety of neoadjuvant intravesical mitomycin-C instillation in non-muscle invasive bladder cancer patients

Study Design: Intervention Model: Single Group Assignment Masking: Open Label

Primary Outcome Measures:

Recurrence-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.

Secondary Outcome Measures:

Progression-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.

Time to recurrence in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.

Change of tumor size after neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.

Safety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.

Eligibility Criteria:
Inclusion Criteria:

* The subjects who will undergo transurethral resection of the tumor after diagnosis of bladder cancer
* Male or female aged 18 or over 18 years and not more than 85 years who were diagnosed as bladder cancer
* Normal bone marrow function: Hemoglobin \>10 g/dL, ANC \>1,500/mm3, platelet count\>100,000/mm3
* Normal renal function: serum creatinine ≤ 1.4 mg/dL
* Normal liver function:
* Bilirubin ≤ 1.5 times of upper normal limit
* AST/ALT ≤ 1.8 times of upper normal limit
* Alkaline phosphatase ≤ 1.8 times of upper normal limit
* Subjects who voluntarily decided to participate and signed the written informed consent

Exclusion Criteria:

* Non-urothelial carcinoma
* Muscle invasive bladder cancer
* Subjects who underwent intravesical mitomycin-C instillation after diagnosis of bladder cancer within 3 years
* Prior hypersensitivity reaction history to mitomycin-C
* Neurogenic bladder
* Subjects who underwent chemotherapy due to any cancer within 6 months
Diagnostic Performance of Arterial Time for CT Assessment of Parietal Enhancement Defect for the Diagnosis of Ischemia in Mechanical Small Bowel Occlusions: a Comparative Study With Portal Time

Intestinal obstruction is a frequent cause of emergency room visits and represents about 4-7% of the causes of acute abdominal pain syndrome and up to 30% in adults over 60 years old.

Although 65 to 80% of patients are treated medically, small bowel obstruction remains a serious pathology, with a high mortality rate that can reach 25% in case of small bowel ischemia. It is necessary to systematically perform a CT scan in the initial workup of small bowel obstructions to confirm the diagnosis, identify the mechanism and detect signs of ischemia that would require emergency surgery.

The best sign for the diagnosis of ischemia is the defect or asymmetry of parietal enhancement of the dilated small bowel. In the literature, this sign is described almost exclusively at portal time. In case of suspicion of mesenteric ischemia (another serious pathology affecting the small bowel), it is recommended to perform an examination with three acquisitions (without injection, arterial time, and portal time).

The department's experience has shown that arterial time is sometimes more sensitive than portal time for visualizing a parietal enhancement defect of the small bowel in mechanical occlusions.

Very few studies have investigated the diagnostic performance of parietal enhancement asymmetry on arterial time in mechanical occlusions of the small bowel.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age is ≥ 18 years
* Patient with a diagnosis of mechanical small bowel obstruction on CT performed between April 2014 and December 2019
* Patient who had a CT scan with at least 3 phases: injection-free, arterial time, portal time
* French-speaking patient

Exclusion Criteria:

* Patient who did not have surgery within the first 24 hours
* Patient with a history of abdomino-pelvic surgery in the month preceding the scan
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient who objects to the use of his or her data for this research
Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy

Prucalopride based bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.

Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost.Unfortunately, despite advances in bowel preparation methods, up to one-third of all colonoscopies are reported to have an inadequate bowel preparation.

Prucalopride can accelerate colonic transit and has been demonstrated to be efficient in constipation.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older,
* scheduled to undergo elective outpatient colonoscopy,
* and were able to provide informed consent.

Exclusion Criteria:

* history of colorectal surgery
* severe colonic stricture or obstructing tumour
* dysphagia
* compromised swallowing reflex or mental status
* significant gastroparesis or gastric outlet obstruction
* known or suspected bowel obstruction or perforation
* severe chronic renal failure (creatinine clearance\<30 ml/min
* severe congestive heart failure (New York Heart Association class III or IV)
* uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg)
* dehydration
* disturbance of electrolytes
* pregnancy or lactation
* haemodynamically unstable
* unable to give informed consent.
Diaphragmatic Dysfunction and Cardiac Surgery; Perioperative Assessment and Effect on Outcome

This study evaluates incidence of diaphragmatic dysfunction after cardiac surgery and its effect on outcome of surgery.

Diaphragmatic dysfunction will be assessed by ultrasonography the day before operation and first post operative day, by measuring diaphragmatic thickening during inspiration and expiration.incidence of diaphragmatic dysfunction and its effect on outcome of surgery then will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and older
* Planned cardiac surgery
* Ready for weaning from mechanical ventilation (fraction of inspired oxygen (FIO2) ≤ 50%, positive end-expiratory pressure(PEEP) level≤ 5 centimeter water (cmH2O), respiratory rate ≤30 breaths/min, partial pressure of oxygen in arterial blood(PaO2)/FIO2 ratio \>200 , Glasgow coma score ≥14).
* Stable cardiovascular status (i.e., heart rate \<120 beats/min; systolic blood pressure, 90-160 mmHg; and no or minimal vasopressor use, i.e., dopamine or dobutamine ≤5 μg/kg/min or noradrenaline ≤0.05 μg/kg/min).
* Stable metabolic status (i.e., electrolytes and glycaemia within normal range, body temperature \<38 °C, hemoglobinemia ≥8-10 g/dL).

Exclusion Criteria:

* Patients with a history of diaphragmatic or neuromuscular disease or evidence of pneumothorax or pneumomediastinum.
* Patients with low EF (EF ≤ 30%).
* Patients with post-operative cerebrovascular stroke.
* Reventilation due to cardiac cause ( arrest, arrhythmias, or failure)
* Patient refusal.