cyrilzakka/clinical-trials huggingface dataset:
Efficacy/Safety of Urogynecology Synthetic Mesh Surgery

This is a retrospective cohort study, aiming at analyzing the efficacy and safety of mesh surgery in pelvic organ prolapse. The synthetic mesh for pelvic organ prolapse include transvaginal mesh or laparotomy, laparoscope, or robotic-assisted laparoscopic sacrocolpopexy with mesh augmentation. The investigators would like to evaluate the efficacy and safety, such as recurrence rates and complication rates for women who underwent urogynecology mesh surgery.

Gynecologic mesh, including transvaginal mesh and mesh used in abdominal or laparoscopic sacrocolpopexy, has been used for pelvic organ prolapse since its debut in the US in 2005. It provides higher success and satisfaction rate than traditional colporrhaphy, but mesh-related complications, such as pain, mesh exposure and bleeding, have been reported. U.S. Food and Drug Administration issued a Safety Update in 2011 to inform the public that serious complications associated with synthetic mesh for the transvaginal repair of POP were common. Taiwan FDA and associated committees decided that the use of gynecologic mesh should be regulated. Thorough study and evaluation are needed.

Eligibility Criteria:
Inclusion Criteria:

* Pelvic organ prolapse patients with objective / subjective voiding dysfunctions
* Underwent surgery for symptomatic POP ≥ stage II (POP-Q system)

Exclusion Criteria:

* Patients with a history of pelvic radiation.
* Patients with a history of vesico-/recto-/urethra-vaginal fistula
* Patients unable to be followed up.
Liraglutide Effectiveness in Preoperative Weight-loss for Bariatric-metabolic Surgery

Severe obesity is associated with considerable reduction of wellbeing and life expectancy. People living with severe obesity tend to die 8 to 10 years earlier. Preoperative management of patients living with severe obesity can be challenging and proper weight-loss may help obtain better outcomes and less morbidity. The effectiveness of GLP-1 analogue Liraglutide in preoperative weight-loss was evaluated in the study.

Objective:

Determine liraglutide effectiveness for preoperative weight-loss in patients with severe obesity undergoing bariatric-metabolic surgery.

Methods:

It is a single center, quasi-experimental prospective before-and-after study. All patients were assigned the same pharmacological treatment with liraglutide, initiating dosing with 0.6 mg per day escalating 0.6 mg every week up to 3.0 mg. The treatment dose was delivered once daily via subcutaneous injection for 3 months (12 weeks). Weight-loss and percentage weight-loss was evaluated monthly using bioelectric impedance (BIA) final result at week 12.

Eligibility Criteria:
Inclusion Criteria:

* Patients with BMI greater than 48 kg/m2 in pre-surgical protocol for bariatric surgery of the Bariatric and Metabolic Surgery Unit of the Civil Hospital of Guadalajara "Dr. Juan I. Menchaca

Exclusion Criteria:

* Patients under 18 years of age or over 65 years of age.

  * Pregnant patients.
  * Patients who do not agree to give their consent and take part in the study.
  * Patients with allergy to liraglutide, multiple endocrine neoplasia type 2 and medullary thyroid cancer, gallstones.

Removal:

* Patients who decide to abandon the study.
* Patients who do not follow the instructions or do not adhere to the treatment.
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients

The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating middle ear infections in children with ear tubes.


Eligibility Criteria:
Inclusion Criteria:

* 6 months to 12 years
* ear tube in the ear which will be treated
* otorrhea for 3 weeks or less
* moderate or severe otorrhea

Exclusion Criteria:

* other ear diseases
Remotely Supervised Exercise Program in Individuals With Type 2 Diabetes

The present study, characterized as a randomized clinical trial, aims to verify the effects of a remotely supervised exercise program, compared to a control group, on cardiometabolic, functional, and psychosocial outcomes in individuals with type 2 diabetes (DMT2). Males and females with T2DM from the city of Pelotas/RS who meet the study eligibility criteria will participate in the study. Participants will be randomized into the intervention group (IG) and control group (CG). The IG will perform a 12-week exercise program supervised remotely via video call, while GC will receive recommendations for physical activity. Participants will be evaluated at baseline (week 0) and after intervention (week 13). Initially, data for sample characterization, blood pressure, capillary blood glucose, and functional tests will collect during a home visit. In a second moment, participants will be invited to go to a specific laboratory for collecting glycated hemoglobin (HbA1c). Subsequently, a third date will be scheduled to apply self-administered questionnaires (online via GoogleDocs) related to the quality of life, sleep quality, depressive symptoms, emotional stress related to diabetes, level of physical activity, and eating habits. Additionally, acute glycemic responses will be evaluated before and immediately after an exercise session three times throughout the intervention. Capillary blood glucose will be collected in sessions performed in the initial period of mesocycles 1, 2, and 4. At week 13, reassessment will be realized by the same baseline assessors. Over the 12 weeks, a combined training will be carried out with remote supervision. Participants will perform strength exercises at usual and maximum execution speed and aerobic exercises at a rating of perceived effort between 11 and 15 on Borg's scale. The sessions will have a total duration between 37 and 57 min and a weekly frequency of two weekly sessions in the first six weeks and three weekly sessions in the remaining six weeks. Data will be expressed as mean and standard deviation. Data analysis between pre-and post-intervention moments, as well as between groups, will be performed by Generalized Estimated Equations, with Bonferroni post hoc, considering both per-protocol (including participants who meet 70% of frequency in the intervention) and intention to treat analysis (including all randomized participants), assuming an alpha level of 5%.


Eligibility Criteria:
Inclusion Criteria:

* Being under medical treatment using oral hypoglycemic agents
* Female and male patients with type 2 diabetes;
* Not be involved with physical exercises in the last three months;
* Being semi-literate.

Exclusion Criteria:

* Make use of insulin;
* History of cardiovascular disease (except drug-controlled high blood pressure);
* Presence of severe autonomic neuropathy, painful peripheral neuropathy or history of foot injuries, proliferative diabetic retinopathy, severe non-proliferative diabetic retinopathy;
* Muscle or joint impairment that precludes performing physical exercises safely
* Lack of internet access
Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-Obturator Way for the Correction of Anterior Prolapse

The classical surgical treatment of an anterior prolapse is the use of autologous tissue. In front of the high rate of recurrences with this technique, the use of synthetic prosthesis made their appearance. But the drawback of the use of prosthesis is their tolerability. The system Perigee®, a prosthetic kit by trans-obturator way, was designed to obtain high efficiency in the correction of the prolapse while reducing the risk of complications. The lack of prospective and randomized studies makes difficult to assess the interest. The investigators, therefore, have put in place a randomized prospective study seeking the evaluation of the system Perigee® compared to the conventional surgical technique.


Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years old
* Genital anterior prolapse requiring surgical correction and with stage III or IV in the classification of Pelvic Organ Prolapse - Quantification or POP-Q
* Ability to understand the information and to sign a consent form
* Patients wishing an intervention because of the inconvenience caused by the prolapse.

Exclusion Criteria:

* Prolapse stage \<III in the classification POP-Q, and prolapse without functional inconvenience
* Progressive or latent infection, or signs of tissue necrosis in the clinical examination
* Troubles resulting in an unacceptable risk of post-surgery complications investigated at the interview with the patient (disorders of blood clotting, immune system disorders, progressive diseases....)
* Mobility of the lower limbs reduced (not permitting the positioning for the surgery)
* Pregnancy or any desire of pregnancy during the study, within two years
* Pelvic surgery in the last 6 months
* Patients who have had radiotherapy of the pelvic area in an irrespective time
* A history of pelvic cancer
* Known hypersensitivity to any component of the prosthesis (polypropylene)
* Uncontrolled diabetes (HbA1c\> 8%)
* Treatment modifying the immune response (immuno-modulators), current or stopped for less than one month
* Inability to understand the information and to sign a consent
* A person not subject to social security, deprived of freedom, or under legal guardian
Enhancing Educational and Vocational Recovery in Adolescents and Young Adults With Early Psychosis Through Supported Employment and Education.

Psychotic disorders often develop a chronic course with devastating consequences for individuals, families, and societies usually with first onset during adolescence and early adulthood. Early intervention programs, which provide intensive, phase specific, psychosocial, and pharmacological treatment for people in the first five years after the initial psychotic episode (early psychosis) can significantly improve the outcome and are therefore strongly recommended in national and international guidelines. However, most early intervention programs in people with early psychosis still focus on improving symptoms and relapse prevention, rather than targeting educational and vocational recovery, although engagement in work and education is a high priority for young people with early psychosis and reduces the social disability associated with the disorder. The aim of the present study is to explore the effects of Supported Employment and Education (SEE) following the Individual Placement and Support (IPS) model in people with early psychosis. The investigators compare treatment as usual (TAU) in an outpatient psychiatric setting to TAU plus SEE.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of early psychosis (DSM 5: schizophrenia spectrum and other psychotic disorders (297.1, 298.8, 295.4, 295.9, 295.7, 298.8, 298.9) within the last 5 years currently treated as outpatients
* sufficient linguistic and intellectual abilities to take part in the study
* interest in competitive employment or/and mainstream education
* written informed consent

Exclusion Criteria:

* Learning disability or mental retardation as well as insufficient German language abilities (\< A2)
* physical or organic handicap that seriously impede work or educational functioning
Effect of Type II Diabetes Mellitus With Neuropathy on the Clinical Use of Rocuronium

International Diabetes Federation estimates that there are now 415 million adults aged 20-79 with diabetes mellitus worldwide. By 2040 this will rise to 640 million. Although diabetes mellitus is highly prevalent in our environment and one of the most important challenges of modern medicine, only a handful of studies have examined the neuromuscular function in diabetic patients. The shortage of publications in this area is still more surprising if we consider that the neuromuscular blockers are one of the pillars in the administration of general anesthesia. Neuromuscular blockers during surgery are used in tracheal intubation and to improve surgical conditions.

In diabetic patients, neuropathy, microvascular and macrovascular complications are known clinical findings which require attention during anesthesia. Partial degeneration or segmental demyelination of the nerve fibers and loss of motor units have been reported in patients with diabetes mellitus as well. Therefore, the effects of a neuromuscular blocking agent should be important because of potential complications from incomplete reversal or residual paralysis during anesthesia maintenance. In a series of studies, vecuronium has been the only agent investigated in patients with diabetes mellitus and other diseases characterized by neuromuscular dysfunction. Delayed recovery from the neuromuscular block after vecuronium administration was shown in patients with diabetes mellitus. Currently, rocuronium, with its rapid onset of action, rapid recovery profile and inactive metabolites, is generally known as a safe agent for anesthesia under normal conditions. It is known that the pharmacokinetic properties of rocuronium can be altered in some diseases, such as renal or hepatic failure. However, it has not been investigated whether the effect of rocuronium on neuromuscular function is changed in the presence of neuropathy in diabetes mellitus patients or not. The rationale of our study arises from the finding of many studies that show different changes in the neurophysiological parameters in diabetes mellitus. In diabetic nerve, the conduction velocity of the action potential is decreased, the amplitude of action potentials, both sensory and motor, is smaller, and the latency time is elongated.

Eligibility Criteria:
Inclusion Criteria:

* adult patients aged from 18 years to 65 years.
* scheduled for abdominal surgery under general anesthesia

Exclusion Criteria:

* Patients with allergy to rocuronium
* those diagnosed with diseases that alter neuromuscular blocker response (e.g., Guillain-Barré syndrome, Duchenne type muscle dystrophies, etc.),
* patients receiving treatment with drugs capable of altering neuromuscular transmission or neuromuscular blocker response (e.g., antiseizure drugs, certain antibiotics, etc.).
Fully Automated Anesthesia, Analgesia and Fluid Management

Evaluate the feasibility and quality of automated anesthesia, analgesia and fluid management based on a combination of several physiological variables (bispectral index \[BIS\], stroke volume \[SV\], and stroke volume variation \[SVV\]) using 2 independent physiologic closed-loop systems (PCLS) in patients undergoing high risk vascular surgery

Evaluate the feasibility and quality of automated anesthesia, analgesia and fluid management based on a combination of several physiological variables (bispectral index \[BIS\], stroke volume \[SV\], and stroke volume variation \[SVV\]) using 2 independent physiologic closed-loop systems (PCLS) in patients undergoing high risk vascular surgery.

All patients will receive total intravenous anesthesia in target controlled infusion mode using the population pharmacokinetic sets of Schnider for propofol and Minto for remifentanil to target the effect-site concentration. Infusion Toolbox 95 version 4.11 software (Free University of Brussels, Brussels, Belgium) implemented in a personal computer serving as a platform for: calculating effect-site concentrations of propofol and remifentanil; displaying effect-site concentration estimates in real time; providing a user interface that permits entry of patients' demographic data (sex, age, weight, and height) and modifications to target concentrations; controlling the propofol and remifentanil infusion pumps (Alaris Medical, Hampshire, United Kingdom); and recording calculated effect-site drug concentrations.

All patients will receive a baseline crystalloid infusion (PlasmaLyte, Baxter, Belgium) delivered by a pump at a rate of 3 mL/ kg/h (Fresenius Kabi, Belgium). Additional fluid was given using a goal-directed fluid therapy protocol guided by the cardiac output monitor (EV-1000; Edwards Lifesciences) and consisted of 100 mL boluses (Voluven, Fresenius Kabi, Germany) delivered by our PCLS (Learning Intravenous Resuscitator \[LIR\]). For fluid output, a Q-Core Sapphire Multi-Therapy Infusion Pump (Q-Core, Israel) was controlled by the LIR using software provided by Q-Core via a serial connection (Commands Server R.01). If hypotension occurred (defined as mean arterial pressure \<20% of baseline blood pressure) and no fluid is delivered by the LIR, it will be treated by the anesthesiologist using a vasopressor drug.

In this pilot study, each closed loop also will operate independently, guided only by its own respective inputs (BIS for the propofol; SV and SVV for the fluid boluses).

The investigators will also measure analgesia using the PhysioDoloris monitoring device (MDoloris Medical Systems, Lille, France).

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for high risk vascular surgery
* Patients American Society Anesthesiologist classification: 3 or 4

Exclusion Criteria:

* age less than 18 years,
* patients with arrhythmias like atrial fibrillation
* allergy to latex, propofol, remifentanil, morphine, muscle relaxant or any of the excipients,
* pregnant woman
* combined general and regional anesthesia,
Influence of the Sensory Profile of Deaf Children With Autism Spectrum Disorders on the Outcome of Cochlear Implantation

An unpublished study conducted at Toulouse University Hospital revealed that 30% of implanted children with Autism Spectrum Disorders abandon their implant, while 70% of them keep it. The aim of this study is to evaluate the causes of this disparity, which is much greater than in children with cochlear implants without associated Autism Spectrum Disorders. Our problem is as follows: do the sensory hypersensitivity and hyposensitivity of deaf children with Autism Spectrum Disorders have an effect on the expected results after a cochlear implantation from a language and auditory reaction point of view?

The present study will specifically focus on the sensory profile of these children with Autism Spectrum Disorders, which could be the cause of these developmental difficulties in language and communication development.

Eligibility Criteria:
Inclusion Criteria:

* Deaf child with cochlear implant
* 15 months to 10 years old and 6 months old at the time of implantation
* Child with autism spectrum disorder (only for children group with autisme spectrum disorder)
* No opposition from the legal representative of the authority to participate in the study

Exclusion Criteria:

* Opposition by the legal representative of the child
* Child under legal protection
Guo's Entry Tear Repair :The First in Man Study of Endopatch System

A prospective, single-center, first in man study to evaluate the safety and efficacy of Endopatch System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the Chronic Stanford B type aortic dissection proximal tear.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 80 years old, no gender limitation;
2. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol;
3. Diagnosed as chronic Stanford type B aortic dissection;
4. Maximum diameter of the intimal tears is between 2mm and 20mm;
5. Important branch vessels will not be covered after intimal tears closure;
6. Aortic endovascular treatment can be performed with appropriate arterial access.

Exclusion Criteria:

1. Diagnosed as acute, subacute aortic dissection;
2. Intermural hematoma, aortic ulcer, pseudoaneurysm, and severe aortic calcification;
3. The minimum distance between the intimal tears of the aortic intimal flaps and the root of the intimal flaps is less than the radius of the patch to be used (the patch cannot be deployed flat);
4. Pregnant, breastfeeding or cannot contraception during the trial period;
5. Participated in clinical trials of other drugs or devices during the same period;
6. The same operation requires intervention in other vascular diseases (such as coronary artery, renal artery, superior mesenteric artery, etc.), and the postoperative drug treatment plan is therefore affected;
7. Allergic to contrast agents, anesthetics, patches, and delivery materials;
8. Cannot tolerate anesthesia;
9. Severe liver, kidney, lung, and heart function abnormalities before surgery \[Serum creatinine exceeds 2 times the upper limit of normal; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper limit of normal; Serum total bilirubin (STB) more than 2 times the upper limit of normal; Left ventricular ejection fraction is lower than normal by cardiac color Doppler ultrasound examination\];
10. History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
11. Life expectancy is less than 12 months (such as advanced malignant tumors)
12. Acute systemic infection
13. Investigator judged that not suitable for interventional treatment.
External Dead Space in Ventilated COVID-19 Patients

The objective is to investigate the efficacy of volumetric capnography to detect changes in dead space, CO2 elimination and shape factor parameters before and after disconnection of external dead space in ventilated COVID-19 patients.

Covid-19 patients under mechanical ventilation are currently managed with a lung protective strategy derived from ARDSnet recommendations. In order to minimize the risk of spread of coronavirus, filters and associated respiratory tubing are incorporated to the breathing circuit, thus increasing apparatus dead space with subsequent increase in dead space ventilation. Considering the already often compromised ability for these patients to adequately clear carbon dioxide (VCO2), adding an external dead space can potentially have a substantial impact on CO2 homeostasis. The study will use volumetric capnography (Vcap) to investigate the influence of external dead space on VCO2 and calculated alveolar dead space.

Objective: 1) To investigate the efficacy of Vcap to detect changes in dead space, VCO2 and shape factor parameters before and after disconnection of external dead space.

2) To register the external dead space impact on arterial carbon dioxide tension (PaCO2).

3) To calculate the alveolar dead space based on Vcap data and arterial blood gas analysis results.

Design and setting: Prospective observational study in an intensive care center for Covid-19 patients in a university hospital.

Patients: Covid-19 positive patients of all age groups under mechanical ventilation. Exclusion criteria is ongoing ECMO treatment

Measurements and results: Vcap and Tcap parameters will be registered during mechanical ventilation and correlated to an arterial blood gas sample. Part of the apparatus dead space will then be reduced via removal of the heat and moister exchange filter (HME) with added tubing resulting in a reduction in volume of approximately 80 ml (i.e. the known volume of the HME filter and associated tubing). After the apparatus dead space is removed, the Vcap will be recorded for approximately 15 minutes and an arterial blood gas will be drawn at the end of the period. The HME and associated tubing will then be reattached to the breathing circuit and Vcap and Tcap parameters will be recorded for approximately 30 minutes and an arterial blood gas will be drawn. Vcap data will be analyzed for dead space, slope of phase III, VCO2 and associated shape factor parameters and compared with Tcap parameters. Changes in Vcap parameters will be tested for statistical significance using one and two-way ANOVA for repeated measures and Bland-Altman analysis will be used for comparison.

Eligibility Criteria:
Inclusion Criteria:

Covid-19 positive patients of all age groups under mechanical ventilation

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Exclusion Criteria:

* Exclusion criteria is ongoing ECMO treatment