cyrilzakka/clinical-trials huggingface dataset:
Subscapularis Repair Augmentation for Total Shoulder Arthroplasty

The primary purpose of this research is to compare the images obtained by ultrasound between a standard repair of the subscapularis tissue and after repair with a Biobrace. The secondary purpose is to determine if there are any clinical differences.

The investigators would like to learn if subscapularis repair augmentation with the Biobrace in total shoulder arthroplasty (reverse and anatomic) will result in sonographic and/or clinical improvements. This will allow for improvements in technique and better outcomes for patients going forward.

Eligibility Criteria:
Inclusion Criteria:

* Total Shoulder Arthroplasty

Exclusion Criteria:

* Vulnerable population
HIIH Versus HMC: Randomized Clinical Trial

Introduction: water aerobics involves the practice of specific aquatic exercises that are based on the use of water resistance as a load and on thrust as an impact reducer, making it possible to perform physical exercise with a lower risk of injury even at a high intensity. Objective: The overall objective of this study will be to compare the effectiveness of high intensity interval versus moderate continuous water aerobics to improve health outcomes in apparently healthy individuals.

Method: randomized clinical trial will be performed in the premises of the College of Physical Education of the Federal University of the São Francisco Valley. 100 adults, of both sexes, will be randomized into two groups, high intensity interval hydrogynastic (HIAI) or moderate continuous aquatic gymnastics (HCM). Individuals will be evaluated for primary endpoints of muscle strength and endurance, aerobic fitness, flexibility and body composition. The secondary outcomes evaluated will be the quality of life, functionality and perception of improvement by a Likert-type Improvement Scale, at the following moments: initial, final and follow-up of one month after the end of the training. Individuals will be assisted for three months, often weekly twice, with sessions lasting 50 min. In order to identify differences between and within the groups, an equation of generalized estimates will be used as regression model with the syntax according to the multivariate model.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 60 years;
* sedentary and who did not perform physiotherapy and physical activity in the last three months;
* clinical and cognitive conditions for swimming pool activities and aerobic exercise; who have not undergone highly complex surgical procedures in the last six months;
* to be able of walking without help equipment and without musculoskeletal or skeletal diseases;
* without contraindications to the practice of exercises; such as: urinary and / or fecal incontinence and dermatological diseases;
* below obesity II with BMI \<40.

Exclusion Criteria:

* if they have up to three consecutive fouls during the hydrogymnastics period;
* if they present any adverse effects, such as: allergy or any dermatitis;
* unable to continue the study due to change of address or hospitalization.
A Study of Perioperative QL1706 in Participants With Untreated dMMR/MSI-H Resectable Colon Cancer

The goal of this clinical trial is to evaluate the efficacy of perioperative QL1706 in participants with untreated T4N0 or Stage III (resectable), microsatellite instability high/ defective mismatch repair (MSI-H/dMMR) colon cancer


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent;
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Untreated pathologically confirmed colon adenocarcinoma
* Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only).
* Has a tumor demonstrating the presence of MSI-H/ dMMR
* Adequate organ function as described in the protocol

Exclusion Criteria:

* Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc
* Has distant metastatic disease.
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has know history of, or any evidence of interstitial lung disease;
* Has an active infection requiring systemic therapy
Stroke Volume Variations and Pulse Pressure Variations Undergoing Artificial Pneumothorax Surgery

Stroke volume variation (SVV) and pulse pressure variation (PPV) have been thought to be sensitive predictors of fluid responsiveness in mechanically ventilated participants. In this paper, the investigators reported a special group of people to use SVV and PPV during their operation. The maintenance of hemodynamic stability and the critical organ perfusion is crucial to the treatment for patients with artificial Pneumothorax during esophageal surgery, because artificial pneumothorax causes incomplete ventilation of one lung. In addition, artificial pneumothorax may seriously affect theparticipant's heart and lung function, brings more challenges to the intraoperative anesthetic management, expecially in volume management. Little information is available about the accuracy of SVV and PPV to predict fluid responsiveness in participants with artificial Pneumothorax during esophageal surgery. It is unclear whether it will affect the accuracy of SVV and PPV, and whether it will cause the change of their threshold values. The investigators will discuss it in the passage and the investigators will give an preliminary mechanism to explain the results.

Backgroud: This study aims to evaluate the ability of stroke volume variation (SVV) and pulse pressure variation (PPV) to predict fluid responsiveness in mechanically ventilated participants with artificial Pneumothorax during esophageal surgery.

Methods: 40 participants, diagnosed with esophageal cancer, undergoing thoracoscopic radical resection of esophageal cancer were studied. All the participants used Vigileo/FloTrac system for analysis. Haemodynamic data such as MAP, HR, SV, SVI, CO, CI, SVV, PPV were recorded before and after volume expansion (VE). Fluid responsiveness was defined as an increase in SVI≥10%(△SVI≥10%). Participants were divided into Responders and Non-responders by changes in △SVI ≥10% and \< 10%. Nonparametric Wilcoxon rank sum test was used to compare the hemodynamic parameters of Responders and Non-responders before and after VE. Pearson correlation analysis was used to analyze the values of SVV, PPV and △SVI. The receiver operating characteristic (ROC) curve of each hemodynamic index was drawn to determine its accuracy and threshold.

Eligibility Criteria:
Inclusion Criteria:

Must be arranged for thoracoscopic surgical treatment of esophageal cancer Must be mechanically ventilated with artificial Pneumothorax during the operation Must be normal in Allen test.

Exclusion Criteria:

Hypertension Coronary heart disease Arrhythmia Left ventricle ejection fractions \< 50% (EF\<50%) Pulmonary hypertension Congenital cardiovascular malformation Peripheral vascular disease Long-term history of oral vasoactive drugs
The Effect of Human Albumin on Coagulation Competence and Hemorrhage

In a randomized clinical trial, the purpose is to investigate if perioperative coagulation and hemorrhage is influenced by colloid or crystalloid.

5% Human Albumin is used for fluid therapy during surgery. This study evaluate whether affected coagulation competence induced by Human Albumin leads to a significant perioperative blood loss when compared to administration of lactated Ringer´s solution.

Data are gathered by the investigators, analysed by the sponsor, and remain confidential throughout the process. The investigators shall be involved in all stages of the study development and vouch for the completeness and accuracy of the data. No third part shall influence the protocol, trial conduct, data analysis, or reporting.

The investigators will include 40 patients undergoing cystectomy. Heart rate, mean arterial pressure, cardiac output are measured after induction of anaesthesia and insertion of the arterial catheter (T0), after establishing normovolaemia but before surgery (T1), after resection of the urinary bladder (T2), at the end of the surgery (T3), and two hours thereafter in the recovery room (T4).

Arterial blood is drawn for whole blood viscoelastic haemostatic assays to record clot initiation (R-Time), formation (Maximal Amplitude, MA), alpha angle(α) and lysis (Ly30) depicting haemostatic competence (thrombelastography). The investigators analyze blood for haemoglobin, creatinine, platelets, and fibrinogen. Furthermore, blood is drawn from the central venous catheter for lactate and blood gas variables (ABL 825, Radiometer, Copenhagen, Denmark). To avoid excessive administration of Human Albumin, patients receive lactated Ringer´s solution if considered needed after the infusion 25 mL/kg of the allocated fluid (non-study fluid).

The fluid balance inclusive the blood loss was calculated after cystectomy, at the end of surgery, and two hours thereafter. The investigators register complications postoperatively inclusive hospital stay until discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patient more than 18 years old
* Indication for elective post-renal operation including cystectomy
* Patient without anticoagulative, acetylsalicylic acid or nonsteroidal antiinflammatory drug

treatment for the last 5 days

Exclusion Criteria:

* Intracerebral bleeding, manifest cardiac insufficient, renal insufficient demanding dialysis, hepatic or coagulation diseases
* Pregnant or nursing
* Allergic to Human Albumin
* Disturbance in electrolytes
* Patient under committee
* Patient joining another trial interfering the actual trial
Sleep Quality After Nasosinusal Surgery in AERD Patients

Aspirin exacerbated respiratory disease presents as a triad composed by asthma, eosinophilic rinosinusitis and intolerance to aspirin and NSAIDS. In subjects with chronic rhinosinusitis sleep alterations have been found, with important improvement after surgery, but those alterations and improvements have not been studied in patients diagnosed with AERD who, due to their comorbidities, may present more severe pre surgical symptoms and a more important post-surgical improvement. The investigators aim to study patients with AERD sleep, quality of life and symptoms before surgery, and one, three and six months post-surgery.


Eligibility Criteria:
Inclusion Criteria:

* AERD patients.
* Cumbersome nasal polyposis with poor treatment response

Exclusion Criteria:

* Previously diagnosed sleep disorder.
* Psychiatric disorder
Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy

The purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.

Laparoscopic surgery, also called minimally invasive surgery (MIS), is a surgical method less invasive than classical laparoscopic open procedure. Particularly, MIS is used for resection of some gynecological cancer such as endometrial cancer, cervical cancer or ovarian cancer. Several studies demonstrated that MIS induce less surgical complications (bleeding, infections, post-operative pains...), shorter hospitalization time, earlier recovery of activity and better quality of life than laparoscopic open procedure.

However, MIS is the selected method in only 9 to 25 % of gynecologic cancer surgery in France. This is likely due to the longer learning curve of MIS compared to laparoscopic open procedure.

In 2001 the FDA allowed the use of robot assisted laparoscopic surgery (RALS). This technique adds some advantage to laparoscopic surgery. Indeed, surgeon operates with better precision while seated comfortably at a computer console viewing a 3-D image of the surgical field. Moreover learning curve of RALS is shorter than MIS. Comparative studies between RALS and MIS demonstrate an equivalence of these techniques for operation length and bleeding. However for surgery linked complications and time for recovery of activity, RALS had better results than MIS.

Despite its expensive cost, RALS is now commonly used in North America (90% of prostatectomy and 40% of cancer linked hysterectomy). However RALS need to be evaluated in a randomized clinical trial before it's acceptation in gyneco-oncology in France.

Thus, the purpose of the ROBOGYN clinical trial is to compare clinical benefit of RALS and MIS in a randomized study for patients with cancer of cervix, uterus or ovary.

Eligibility Criteria:
Inclusion Criteria:

* patient with uterus cancer depending on hysterectomy ± pelvic lymphadenectomy or a restadification
* patient with cervical cancer depending on enlarged colpo-hysterectomy ± pelvic lymphadenectomy or a surgery after concomitant radiochemotherapy, or lombo aortic lymphadenectomy for a locally advanced cancer, or a restadification
* patient with cervical cancer depending on a restadification
* patient aged over 18 years
* previous antitumor treatment allowed but necessarily disrupted 20 days before inclusion
* WHO score equal or inferior to 3
* cirrhosis-related Child-Pugh score under or equal to A7 are allowed
* life expectancy equal or superior to 12 weeks
* patient affiliated to health insurance
* dated and signed informed consent

Exclusion Criteria:

* metastatic disease
* pregnant or breastfeeding woman
* patient unable to proceed follow-up visit, because of geographic, social or mental reasons
Progression of Active Microcavitated Carious Lesions on Primary Molar Occlusal Surfaces

Objective: To verify the progression of active microcavitated carious lesions on occlusal surfaces of primary molars after the orientation of the brushing technique associated with fluoride dentifrice compared to resin sealant, through a 12-month randomized clinical trial. Methodology: We selected 22 children from 4 to 9 years old from the public school system of the city of Juazeiro do Norte-Ceará, with at least one primary molar presenting an active caries lesion score 3 of the International Caries Detection and Assessment System (ICDAS). Randomization was performed en bloc and stratified by two conditions (age and caries experience). The selected teeth were divided into two groups: the first (G1) was submitted to brushing with fluoridated toothpaste; and the other group (G2) to the resin sealing technique, whose application of the material was performed under absolute or relative isolation, selected through a second randomization. The molars undergoing treatment were evaluated at 6- and 12-month returns. Caries progression was evaluated according to the type of treatment, dental group and sealant retention by the Chi-square test. For cost analysis, the variance test (ANOVA) was used.


Eligibility Criteria:
Inclusion Criteria:

* At least one primary molar with active caries lesions classified as ICDAS score 3.

Exclusion Criteria:

* Children with differentiated management needs and/or systemic diseases with oral involvement.
* Primary molar with active caries lesions classified as ICDAS score 3 that had other caries lesions involving dentin, restorations, sealants, or other types of formation defects.
Diabetes Virtual Trek: Obesity and Diabetes Prevention Through Science Enrichment

The purpose of this study was to evaluate the effectiveness of a school-to-home education program for it's ability to increase knowledge about, and ability to prevent type two diabetes in children and parents.

The study involved pre and post testing of parent's knowledge and behaviors relating to the prevention of type two diabetes, before and after a school based intervention designed to encourage school to home communication. Parents/Guardians and children, grades 2-6, from schools with high Hispanic enrollment during the 2001-2005 school year were used for both comparison and intervention groups.

Eligibility Criteria:
Inclusion Criteria:

* Elementary school children in grade 2-6 in intervention or comparison classes/schools
Cognoa Autism Spectrum Disorder (ASD) Digital Therapeutic Engagement and Usability Study

Cognoa will measure usability, engagement with the device, and changes in parent-reported socialization during a 4-week period of intervention at home with the Cognoa ASD therapeutic device.

Parents who consent will be given access to the study device through its caregiver and child-facing smartphone app that provides therapeutic content. In order to access the study device app, parents will be provided access to two other apps. The first is Testflight. TestFlight is an online service for over-the-air installation and testing of mobile applications, currently owned by Apple Inc.that allows users to test iOS apps before they are released to the App Store. Parents will also be provided access to the Cognoa for Child Development app in order to create an account as a means to gain access to the study device app. The parents will only be able to engage with the study device app once they have created an account in the Cognoa for Child for Development app

Eligibility Criteria:
Inclusion Criteria:

* Functional English language capability in the home environment.
* Parent, Guardian, or legal authorized representative (LAR) must be able to read, understand and sign the Informed Consent Form (ICF)
* Female or Male, \> 3 to \< 9 years of age and parent/caregiver
* Diagnosis of Autism Spectrum Disorder, within the last 12 months
* Parent, Guardian, or legal authorized representative (LAR) must have smartphone capabilities for downloading Testflight software; test versions of the Cognoa for Child development app; and test versions of the Cognoa Digital Therapeutic app (iOS 12.0 and up and Apple iPhone 8 and higher)

Exclusion Criteria:

* Participants with any other medical, behavioral, or developmental condition that in the opinion of the investigator may confound study data/assessments.
* Participants with planned extensive travel (more than 1 week) during the course of the 4 week intervention time period.
* Participants with deafness or blindness.
* Participants with known physical impairments affecting their ability to use their hands.
* Participants with active diagnosis of epilepsy and uncontrolled seizures.
* Participants whose age on the date of enrollment is outside the target age range
Impact of Cold Ischemia on Pulmonary Endothelial Dysfunction in Ex-vivo Pulmonary Reconditioning

The study population will be patients with planned double-lung transplant, with preoperative ex-vivo reconditioning procedure.

The ex-vivo procedure will be performed for lungs considered as limit to be directly implanted according to the national classification or in case of Maastrich 3 decision. They required a rehabilitation procedure like ex-vivo to determine their quality. Once the procedure initiated, the unused remaining liquid will be retrieved for the first gasometry usually performed. This will be the time T1 of sampling.

The unused remaining liquid will be retrieved for the gasometry of end of procedure usually performed, before the graft cooling. This will be the time T2.

The purge liquid of first lung at the declamping of the pulmonary artery will be retrieved at the time of unclamping (time T3 of sampling).

The purge liquid of the second lung at the declamping of the pulmonary artery will be retrieved with the same procedure (time T4 of sampling).

The samples will be analysed with ELISA technique. The endothelial dysfunction will be evaluated with plasma concentration of heparan sulphate, syndecan-1, endothelin-1 and i-NOS.


Eligibility Criteria:
Selection Criteria:

* patient aged \> 18 years old
* patient with healthcare insurance
* non-opposition of the patient
* patient with usual criteria for lung transplant and planned lung transplant after meeting of staff transplant

Non Selection Criteria:

* participation refusal
* patient under tutorship or guardianship
* protected adult

Inclusion Criteria:

* selected patient with Biomedecine Agency agreement for graft allocation off tour

Exclusion Criteria:

* selected patient with Biomedicine Agency agreement for standard allocation graft
Synbiotics in Infants With Cyanotic Congenital Heart Disease

Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. The investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in infants with CHD

Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. Probiotics may prevent pathogen colonization in infants with CHD. Therefore, the investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in infants with CHD

Eligibility Criteria:
Inclusion Criteria:

* Cyanotic congenital heart disease
* infants \>35 weeks of gestational age
* Born at or transferred to Sami Ulus CH

Exclusion Criteria:

* Congenital anomalies of the intestinal tract
Naloxegol Drug Utilization Post Authorisation Safety Study

This post-authorization observational safety study determines the characteristics of patients prescribed naloxegol at time of first prescription and treatment patterns of naloxegol in follow-up in the United Kingdom (UK), Norway, Sweden, and Germany.

The overall research questions for this study are: 1) What are the demographic, clinical, and treatment characteristics (including dose) at baseline of patients prescribed naloxegol in real-world practice (including the use of naloxegol in non-indicated populations)? and 2) What are the treatment patterns of naloxegol utilization during follow-up?

Primary objectives:

1. To describe the characteristics of patients prescribed naloxegol at time of first prescription (demographics, targeted comorbidities, targeted comedications, provider characteristics, and indication characteristics).
2. To describe any of the following treatment patterns:

   * Discontinuation of naloxegol (permanently during the observation period)
   * Switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (OIC)
   * Prescription of other drug(s) potentially used by patients with OIC in the same period when naloxegol is prescribed (augmentation)
   * Restart in the prescription of naloxegol (after temporary discontinuation or treatment holiday)
   * Continuous treatment with naloxegol during the study period
   * Change in dosing

Exploratory objective:

1. To identify predictors of length of naloxegol use

Eligibility Criteria:
Inclusion Criteria:

1. The patient has at least 1 prescription of naloxegol in his/her medical record anytime during the study period.
2. The patient has at least 12 months of computerized records prior to the first prescription of naloxegol (index date)

Exclusion Criteria:

* No exclusion criteria will be applied
"Facts Tell… and With Stories Sell?" Combining Viewer-tailored Personal Human Papillomavirus (HPV) Narrative Video With HPV Vaccine Information Video to Improve HPV Vaccine Uptake

This study will compare the use of informational videos only, personal story videos only, and the combination of both, to see which is most effective in increasing HPV vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Parents of 11-17 year olds not yet vaccinated against HPV

Exclusion Criteria:

* Parents whose adolescent children are already vaccinated against HPV
* Participants who do not complete the survey
* Participants who are unable or refuse to view and listen to videos on the participant's device