cyrilzakka/clinical-trials huggingface dataset:
Minirin Versus Oxybutynin for Nocturnal Enuresis in Children

Nocturnal enuresis is among the most common disorders in children. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014.

Nocturnal enuresis is among the most common disorders in children. Several pharmacological and non-pharmacological treatments are available for nocturnal enuresis. Studies for reaching the best pharmacological treatment for this disorder are continuing. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014.

Eligibility Criteria:
Inclusion Criteria:

* \>5 years old
* Nocturnal enuresis
* Candidate for pharmacological treatment

Exclusion Criteria:

* Children who their parents did noted filled the informed consent form
* Impossibility of follow up during the study period
* History of seizure
* History of rheumatologic disorders such as sjogren's disease
ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling

The Investigator propose a randomized trial that will assess whether participant involvement in pre-operative counseling for ERAS improves post-surgical pain scores. The Investigator will also assess participant compliance to ERAS-prescribed medications, and functionality (return to school). Each participant who is enrolled in the study will be assigned to 1) pre-operative counseling with participant's caregiver or 2) caregiver-only counseling.

Enhanced Recovery After Surgery (ERAS) protocols have been shown to be safe and effective in pediatric and adolescent gynecology (PAG) participants. However, the individual elements of ERAS that are associated with positive outcomes have not been identified. Pre-operative counseling and education is a standard component of ERAS. In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the participant's caregiver rather than directly to the participant. It is possible that direct participant involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes. To investigator's knowledge, no studies have examined the impact of direct participant involvement in pre-operative counseling on ERAS outcomes in the PAG population.

The Investigator propose a randomized trial that will assess whether participant involvement in pre-operative counseling for ERAS improves post-surgical pain scores. The Investigator will also assess participant compliance to ERAS-prescribed medications, and functionality (return to school). Each participant who is enrolled in the study will be assigned to 1) pre-operative counseling with participant's caregiver or 2) caregiver-only counseling.

Eligibility Criteria:
Inclusion Criteria:

* 9- 17 years of age
* Patient is undergoing abdominal surgery and being managed under the ERAS protocol

Exclusion Criteria:

* Developmental delay (IQ \< 70) determined by documentation in medical record
* Emergency or non-elective surgical cases
* Patients who attend clinic appointments independently from their caregiver
Efficacy and Safety of Desmopressin (Nocturin®) 0.1 mg Tablets in Treatment of Nocturia in Participants With Benign Prostate Syndrome (BPS)

Documentation of the efficacy and safety of desmopressin (Nocturin®) 0.1 mg tablet. Observation of patients with benign prostate syndrome, in whom nocturia associated with nocturnal polyuria is treated with desmopressin (Nocturin®) 0.1 mg tablet focusing on number of nocturnal voids, ratio of night/24-h urine volume (%), duration of first undisturbed sleep period and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Therapeutic need according to Summary of Product Characteristics
* Written informed consent

Exclusion Criteria:

* Contraindications according to Summary of Product Characteristics
Palliative, Rehabilitation, and Integrated Medicine Handbook for Self Care at Work

This study investigates the usefulness of the Self Care at Work Handbook in order to generate an improved version. Information from this study may help researchers identify potential factors associated with perception and usefulness of the Self Care at Work Handbook.

PRIMARY OBJECTIVES:

I. To explore the global perception of the perceived usefulness of the handbook, and the frequency that the handbook is consulted.

II. To explore the perceived usefulness of and adherence to each individual item of the handbook.

III. To solicit personnel for their ideas about the handbook, and particularly any additional handbook items they might suggest.

IV. To explore any relationships between the actual use or the perceived importance of each handbook item with respondents' self-reported professional satisfaction.

V. To explore any associations between responses to handbook items and professional, demographic, and work satisfaction characteristics before and during the coronavirus disease 2019 (COVID-19) crisis.

VI. To explore respondents' global perceptions of the usefulness and adherence to the handbook before and during the COVID-19 crisis.

OUTLINE:

Participants complete a survey over 20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Clinicians in the Department of Palliative, Rehabilitation, and Integrative Medicine. This includes physicians, advanced practice providers (APPs), and other clinical staff in the Supportive Care Center and Acute Palliative Care Unit

Exclusion Criteria:

No
Decision-Making Processes While Online Grocery Shopping

Individuals living with food insecurity are disproportionately affected by overweight and obesity and associated chronic health problems. There remains a lack of sustainable and scalable interventions targeting widespread barriers to access to healthy foods in this population to increase the nutritional quality of foods purchased for preparation and consumption at home.

This randomized controlled proof-of-principle trial was designed to examine the feasibility and initial efficacy of a "default option" in enhancing the nutritional quality of groceries selected via the online shopping service of a local grocery store under conditions that mimic the financial constraints typical of individuals living with food insecurity.

In behavioral economics, the "default option" refers to the option a consumer selects if no active choice is made. The notion of the default option is based on the concept of "asymmetrical" or "libertarian paternalism," which seeks to subtly shift consumer behavior in a manner that promotes welfare, but without overtly interfering with the individual's freedom to choose.

It was hypothesized that the "default" option effectively increases the nutritional quality of foods purchased online, compared to monetary incentives and psychoeducation about nutrition.

Female undergraduate students (n = 60) selected food for one week using the online shopping service of a local grocery store with a budget corresponding to maximum weekly Supplemental Nutrition Assistance Program (SNAP) benefits. Before completing the task again, participants were randomized to: (1) a small monetary "incentive" for selecting groceries that meet nutritional guidelines (n = 17), (2) an "educational" brochure (n = 24), or (3) a "default" pre-filled online shopping cart containing a nutritionally balanced selection of groceries to which they could freely make changes (n = 18).

Primary outcome measures capture the nutritional quality of groceries selected/ purchased.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* fluent in written and spoken English
* able to provide informed consent

Exclusion Criteria:

* significant dietary restrictions (i.e., meat avoidance, food allergies, religious dietary restrictions, etc.)
* likely presence of current eating disorder diagnosis (score \>/= 2 on SCOFF screening measure)
A Phase IV Study of Cipro XR in Uncomplicated UTI

Safety and efficacy of Cipro XR in a naturalistic setting and the effectiveness of an educational brochure. - Women with urinary tract infections were treated with Cipro XR. They were also given a brochure with information about urinary tract infections and later tested on the information.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory women outpatients 18 to 65 years of age with a documented clinical diagnosis of uUTI characterized by dysuria with either urgency or frequency. Women of childbearing age were enrolled only if they were highly unlikely to conceive during the study and were practicing a suitable method of birth control or were at least 1 year postmenopausal.
* Positive leukocyte esterase (\>/= 1+) and positive nitrite test using a urine dipstick method of analysis.
* Willing to give written consent.

Exclusion Criteria:

* Pregnant or nursing
* Complicated UTI
* Allergy to Cipro XR
Does Neck Circumference Help to Predict Difficult Airway in Obstetric Patients?

Failed intubation and ventilation in obstetrics remains one of the most common causes of death directly related to anesthesia. The reported incidence of failed intubation in obstetrics is 1:300, which is significantly higher than that in the non-obstetric population. A clinical screening test with high sensitivity and specificity for prediction of difficult airway may help reduce morbidity and mortality from general anesthesia. Few studies have identified increased neck circumference as the best single predictor of problematic intubation. However the cutoff point of this test for identifying patients at high risk of difficult intubation is not clear.

The aim of this study is to determine the optimal cutoff point, which validates prediction of difficult ventilation and/or intubation for obstetric patients. Preoperative airway assessment will be done including neck circumference. Intraoperative difficult ventilation and/or intubation will be recorded. Optimal cutoff point of neck circumference will be calculated by Receiver Operating characteristics (ROC) curve.

In this prospective study, patients will be assessed by the anaesthetist preoperatively and asked about their medical history including detailed history of obstructive sleep apnea (OSA) and snoring. Physical examination including weight,height \&BMI .

Airway assessment will include:

1. Maximum mouth opening measured as interincisor gap (mm).
2. Sternomental distance measured as the straight distance between the upper border of manubrium sterni and the bony point of the mentum with the head in full extension and the mouth is closed (cm).
3. Hyomental distance measured from just above the hyoid bone to the tip to the anterior-most part of the mentum in both neutral position and with maximum head extension (cm). Hence, hyomental distance ratio (HMDR) will be calculated.
4. Thyromental distance measured as the distance from the thyroid notch to the inner margin of the mental prominence when the head is fully extended (cm).
5. Extended Mallampati Score (EMS) in sitting position with full extension of craniocervical junction with phonation (class I: Entire Uvula is clearly visible; class II: Upper half of the uvula is visible; class III: soft and hard palate clearly visible; and class IV: Only hard palate is visible).
6. Neck Circumference at the level of the thyroid cartilage (cm).
7. Condition of the teeth (Protrusion, loose, missing).
8. Mandibular protrusion test to detect temporomandibular joint mobility measured as ability to move the lower teeth in front of the upper teeth.

Intubation will be considered difficult if the Intubation Difficulty Scale ( IDS) is equal or more than 5 .

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for cesarean section under general anesthesia

Exclusion Criteria:

* Patients with upper airway pathology
* Patients with cervical spine abnormality
* Emergency cesarean section
* Known cases of difficult intubation
Incidence of Neurogenic Paraosteoarthropathies in a Population of Brain Traumatized and Spinal Cord Injured Patients and Specific Markers of Early NPOA Development"

Neurogenic paraosteoarthropathies are peri-articular bone formations that may occur as a result of central neurological injury. Their occurrence limits reeducation and recovery capacities. Neurogenic paraosteoarthropathies sometimes cause complications (pain, joint stiffness, vascular and nerve compression, pressure sores) in patients already suffering from severe neurological sequelae affecting functional prognosis. A lot of clinical research work has been carried out within Dr Salga team. Subsequently, a collaboration was born with fundamental research teams (Pr Levesque, Pr Le Bousse Kerdilès, Pr Banzet, Pr Genêt) allowing translational work between humans and animals. The clinical application of recent research findings now makes it possible to launch the very first prospective study on neurogenic paraosteoarthropathies.

Based on the results of collaborative and translational (human-animal) work, investigators wish to conduct the first prospective study that would allow:

(i) To assess the incidence of Neurogenic paraosteoarthropathies (clinical suspicion and radiological confirmation). The prospective nature of this clinical data collection will make it possible to avoid the biases attributed to the retrospective studies conducted to date.

ii) Early detection of patients at risk of developing Neurogenic paraosteoarthropathies, using specific biomarkers and clinical parameters. Early diagnosis could prevent complications and functional impact of Neurogenic paraosteoarthropathies.

Investigators have chosen to restrict population to patients most at risk of developing Neurogenic paraosteoarthropathies as a result of the central neurological event in order to have 2 populations appear at the end of the study: a population with Neurogenic paraosteoarthropathies and a population without Neurogenic paraosteoarthropathies that can be compared.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female \> 18 years old,
* brain trauma with initial Glasgow score \< 8,
* or brain trauma with an initial Glasgow score between 8 and 14 associated with an Injury Severity Score (ISS) \> 15 and surgery within 24 hours of admission or traumatic spinal cord injury with complete neurological impairment (initial para/tetraplegia),
* Complete traumatic spinal cord injury. Accident less than 48 hours old
* Informed consent signed by the patient or a family member

Exclusion Criteria:

* Age \< 18 years,
* Hemorrhagic shock or blood transfusion greater than or equal to 4 red blood cells within 6 hours of the trauma (also include pre-hospital or first hospital red blood cells)
* Follow-up impossible over one year,
* Patient not living in the Paris region,
* Pregnant or breastfeeding woman,
* Patient under guardianship or curatorship,
* No affiliation to a social security scheme or universal mutual fund.
Stavanger IBD Study - Cross Sectional

In this cross sectional and longitudinal study, patients with inflammatory bowel disease on biological treatment with infliximab or adalimumab will be included.

After inclusion, the dosage of their existing biological therapy will be adjusted following regular trough-level and antibody-level monitoring, according to a treatment algorithm.

Disease activity markers, fatigue and QoL will be assessed during the study. The hypothesis is that therapeutic drug monitoring may improve clinical disease outcome after one year of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with inflammatory bowel disease on treatment with infliximab or adalimumab of any duration (at least 3 doses)

Exclusion Criteria:

* Inability to consent
* Inability to adhere to treatment protocol.
Prospective, Multicenter, Observational Study of Apatinib Single or Combined Capecitabine for Treatment of Patients With Metastatic Her-2 Negative Breast Cancer

The purpose of this study is to assess the efficacy and safety of patients who receive apatinib single or combined capecitabine for treatment of patients with metastatic her-2 negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years old (female)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Pathologically diagnosed with her-2 negative, ER/PR negative, ER/PR positive after the failure of endocrine treatment, and had not more than three chemotherapy regimens (must include anthracycline-based and yew class), and the final failure of chemotherapy regimens in patients with advanced breast cancer; Note: treatment failure include (1) during or after the completion of six months or less disease progress of neoadjuvant or adjuvant therapy; (2) rescue treatment in progress within 3 months or less
* Patients with at least one measurable lesions of the advanced breast cancer， measurable lesions has not received radiotherapy or other treatment, unless progress after treatment (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1 and WHO);
* Major organ function has to meet the following certeria:

  1. For results of blood routine test (without blood transfusion within 14 days)

     1. HB≥100g/L;
     2. ANC≥1.5×109/L;
     3. PLT≥75×109/L;
  2. For results of blood biochemical test：

     1. TBIL\<1.5ULN；
     2. ALTand AST\<2.5ULN, but5\<ULN if the transferanse elevation is due to liver metastases；
     3. Serum creatinine ≤1.25ULN , or calculated creatinine clearance\>45 ml/min(per the Cockcroft-Gault formula); 6.Participants were willing to join in this study, and written informed consent.

Exclusion Criteria:

1. The patients with the failure of capecitabine treatment；
2. The patients with chest wall invasion, or chest wall large canker has a tendency to transfer；
3. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg), with classⅡand above coronary heart disease, unable to control arrhythmia (including QTc lengthened women \> 470 ms) and classⅢ-Ⅳcardiac insufficiency; or Left ventricular ejection fraction (LVEF) \< 50%；
4. A variety of factors influencing oral drugs (such as unable to swallow, after resection of the gastrointestinal, chronic diarrhea and intestinal obstruction, etc.)；
5. Has a history of bleeding, the clinical significance of bleeding symptoms, patients with definite bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers, baseline period （+ +）and above of defecate occult blood, vasculitis, etc；
6. Received a major surgery within 4 weeks or severe traumatic injury, fractures, or has a poor healing wound；
7. Allergic to apatinib and supplementary material；
8. Patients with active brain metastases;
9. Patients with pregnant or planning a pregnancy;
10. The researchers think inappropriate.
Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

The goal of the current trial is to obtain long term efficacy, safety and tolerability data of once weekly aripiprazole in children and adolescents with Tourette's Disorder.


Eligibility Criteria:
Inclusion Criteria:

* The participants successfully completed the final assessment visit in either Study 31-10-272 (NCT01418339) or 31-10-273 (NCT01418352). The participants completed all required assessments for the Week 8/Early Termination Visit to be eligible for rollover in to this open-label trial.
* Written informed consent form (ICF) obtained from a legally acceptable representative \& informed assent at Baseline as applicable by trial center's Institutional review board/independent ethics committee (IRB/IEC).
* The participant, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator.

Exclusion Criteria:

* The participants experienced adverse events (AEs) during the double-blind study 31-10-272 (NCT01418339) or 31-10-273 (NCT01418352) that would, in the investigator's judgment, preclude further exposure to aripiprazole.
* The participants had protocol violations during the double-blind trial considered major in the judgment of the investigator which would deem the participant a poor candidate for the trial.
* A positive drug screen at baseline for cocaine, alcohol or other drugs of abuse which will result in early termination at Week 1.
* Sexually active patients who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 90 and 30 days following the last dose of study drug for male and female respectively.
* Participants representing Risk of committing suicide.
* Body weight lower than 16 kg.
* Abnormal laboratory test results (Platelet, Hemoglobin, Neutrophils, Aspartate aminotransferase, Alanine aminotransferase, Creatinine) vital signs and Electrocardiogram (ECG) results.
German Ablation Quality-Register

The goal of this register is the documentation of the success as well as of the complications regarding interventional therapy of cardiac arrhythmia by catheter ablation. This is the necessary basis for quality management and development of possible improvements of catheter ablation.

The interventional therapy of heartbeat disturbances by means of catheter ablation makes the curative treatment possible of numerous tachycardiac arrhythmics. By this crucial improvement of the supply of patients and its quality of life a genuine healing of a multiplicity of heartbeat disturbances became possible. Especially within the range of the ablation treatment there are relatively few con-trolled studies, which would give a broad collection of the results of the catheter ablation in the different indication areas.

Aim of the registry:

Documentation of indication, hospital course and complications during long term follow-up of patients with catheter ablation

Design:

Prospective, multicenter registry; FU-duration 12 months.

Duration:

Phase I: 2 years

Inclusion criteria:

Catheter ablation (intention to treat)

Exclusion criteria:

Missing declaration of consent

Eligibility Criteria:
Inclusion Criteria:

* The ablation register will include all consecutive patients with a performed or attempted electrophysiological ablation

Exclusion Criteria:

* Missing signed informed consent