cyrilzakka/clinical-trials huggingface dataset:
Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair

This is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has been designed as a superiority study to proof the concept of previously published mathematical model of front abdominal wall.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent Form (ICF) signed by the patient or his/her legal representative
* primary or secondary ventral hernia less than 20 cm in length and less than 11 cm in width requiring elective surgical repair
* recurrence after former abdominal hernia repair WITH MESH
* recurrence after suture abdominal hernia repair CAN be included

Exclusion Criteria:

* no written informed consent
* patient under 18 years old
* emergency surgery (incarcerated hernia)
* patients with expected life time shorter than one year for example due to generalised malignancy
* BMI exceeding 40.0kg/m²
* contaminated surgical fields
* patients on immunosuppression, steroid therapy, constant pain therapy
Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl-sedation for Flexible Bronchoscopy: A Randomized, Single Blind, Controlled Study of Satisfaction and Safety.

Flexible bronchoscopy almost always requires sedation to be successful. In order to increase the availability of propofol for sedation, non-anaesthesiologist administered propofol sedation has been suggested as an alternative to traditional midazolam/opioid sedation or the general anaesthesia provided by anaesthesiologists.

Hypothesis: Patients undergoing flexible bronchoscopy prefers non-anaesthesiologist administered sedation with propofol as opposed to non-anaesthesiologist administered sedation with midazolam and fentanyl.

Propofol sedation is as safe as midazolam and fentanyl sedation.


Eligibility Criteria:
Inclusion Criteria:

1. Elective flexible bronchoscopy.
2. Willing to be randomised
3. Provide written informed consent

Exclusion Criteria:

1. Allergy to contents administered
2. pregnant or nursing
3. \<18 years of age
4. Not able to complete questionnaire
5. Acute condition
6. severe COPD
7. \> ASA II
8. Sleep apnea
9. Risk of aspiration
10. Previously difficulty with anesthesia
11. Difficult airway
Delays to Influence Snack Choice

The pervasiveness of high-calorie, nutrient-poor snacks in the environment is believed to have contributed to the epidemic levels of obesity and cardiometabolic disease in the U.S. This project tests whether a novel snack vending machine system that uses brief time delays to reduce the immediacy of reward from unhealthy snacks will improve the healthfulness of snack choices. If successful, this project will identify a new environmental intervention that could contribute substantially to obesity and cardiometabolic disease prevention efforts in schools, worksites, and other settings.

Environmental interventions that address the high availability of unhealthy snacks in the environment are needed to prevent a large projected increase in the incidence of obesity and cardiometabolic disease in the U.S. Prior studies from the investigators group and others suggests that the human preference for immediate gratification from food drives dietary overconsumption, but this knowledge has not yet translated to more effective dietary intervention strategies. This project tests whether a novel snack vending machine system that uses brief time delays to reduce the immediacy of reward from unhealthy snacks will improve the healthfulness of snack choices. This study uses an experimental design to compare brief time delays, two forms of 25% differential pricing, and time delays combined with both forms of 25% differential pricing on their ability to increase purchasing of healthy snacks. Test machines will be placed in existing, high-volume vending locations, and each of these five experimental conditions will run for roughly four weeks. Additionally, baseline purchasing under no intervention will be monitored for four weeks before and four weeks after the five experimental conditions. Specific Aim 2 compares the effects of these five interventions against baseline on the proportion of total vending sales from healthy snacks. Specific Aim 3 tests whether time delays or differential pricing harm overall vending machine sales in the test machines. This study not only tests a compelling theory about the effects of time delays and immediate reward on food choice, but evaluates the efficacy and feasibility of a novel intervention to improve the healthfulness of snack choices in worksites, schools, and other settings.

Eligibility Criteria:
Inclusion Criteria:

* Not applicable

Exclusion Criteria:

* Not applicable
Prognostic Impact of Delta-haemolysin Production Deficiency in Staphylococcus Aureus on the Prognosis of Infected Implant Treated by DAIR

The aim of this study is to determine if delta-haemolysin production deficiency of Staphylococcus aureus is a marker in favour of chronic infections on implants


Eligibility Criteria:
Inclusion Criteria:

* patients having implant infection due to S. aureus treated by DAIR

Exclusion Criteria:

* none
Adjuvant Gemcitabine Plus Oxaliplatin Versus Gemcitabine Plus Cisplatin for Completely Resected Stage IB/II/IIIA NSCLC

Oxaliplatin has a more manageable toxicity profile than cisplatin, with no renal toxicity and a lower incidence of hematological and gastrointestinal toxicities. The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic index. Given the potential advantages of oxaliplatin and th finding that the addition of chemotherapy improves survival in the postoperative adjuvant setting, we conduct a phase II trial to compare adjuvant gemcitabine-oxaliplatin with gemcitabine-cisplatin in patients with completely resected stage IB, II or IIIA NSCLC

This study is a randomized phase II study. Patients are randomized to 1 of 2 treatment arms: patients receive adjuvant chemotherapy with gemcitabine-oxaliplatin or gemcitabine-cisplatin. Chemotherapy should be started within 8 weeks after complete surgical resection. Patients are followed every 3 months for 2 years, every 6 months for 3 years.

Gemcitabine-Oxaliplatin (GemOx) chemotherapy:

Gemcitabine (1,250 mg/m2)+Oxaliplatin (85 mg/m2) is given on day 1 and 15 q 4weeks. maximum 4 cycles.

Gemcitabine-Cisplatin (GemCis) chemotherapy:

Gemcitabine (1,250 mg/m2) + Cisplatin (40 mg/m2) is given on day 1 and 15 q 4weeks. maximum 4 cycles.

Eligibility Criteria:
Inclusion Criteria:

1. Histologic diagnosis of non-small cell lung cancer.
2. Presence of pathological stage IB, II or IIIA, according to the American Joint Committee on Cancer (AJCC).
3. Completely resected tumor at NCC hospital.
4. No prior tumor therapy (radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy).
5. Performance status of 0-1 on ECOG scale.
6. At least 18 years old
7. Patient compliance that allows adequate follow-up.
8. Adequate organ function including the following:Adequate hematologic function: WBC count ≥ 4,000/uL, absolute neutrophil count (ANC) ≥ 1,500/uL, platelet count ≥ 100,000/uL, and hemoglobin ³ 10 gm/dL.Adequate hepatic function: bilirubin ≤ 1.5 x UNL, ALT or AST ≤ 2.5 x UNL.Adequate renal function: creatinine ≤ 1.5mg/dL.
9. Signed informed consent from patient or legal representative.
10. Patients with reproductive potential must use an approved contraceptive method during and for 3 months after the study. Females with childbearing potential must have a negative urine hCG test within 7 days prior to study enrollment.

Exclusion Criteria:

1. Concurrent administration of any other tumor therapy, including radiotherapy, chemotherapy, immunotherapy.
2. Active uncontrolled infection.
3. Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
4. Second primary malignancy.
5. Significant neurological or mental disorder.
6. Pregnant or nursing.
7. MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia
Circulating Tumor DNA Collection From Patients With High Grade Gliomas

Improved outcomes for high-grade gliomas (HGG) require advances in our ability to monitor changes to tumour biology using non-surgical approaches. "Liquid biopsy" is a term used to describe a technique whereby tumour DNA, which has been shed off and then circulates through the blood stream, is detected and analyzed. Our goal is to develop a new type of liquid biopsy that is suitable for primary brain tumours that uses a method that is highly sensitive and allows for ongoing analysis of these tumours.

The study objective is to determine the feasibility of measuring both the burden and key molecular features of HGG through profiling of plasma circulating tumour DNA (ctDNA). This will be determined by detecting ctDNA in samples from HGG patients, and measuring changes in ctDNA levels over time following HGG treatment. 50 eligible patients will be enrolled in the study at University Health Network, and up to 10 blood samples will be obtained; up to 2 blood samples prior to their radiotherapy treatment, and 8 blood samples after their radiotherapy treatment. If available, tissue samples that are stored at UHN will also be collected for DNA extraction.

Eligibility Criteria:
Inclusion Criteria:

* Patients can be enrolled either prior to a planned surgery/biopsy for a suspected HGG or after biopsy/surgery of pathologically proven, previously untreated HGG, prior to adjuvant radiotherapy
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
* Age ≥18 yrs

Exclusion Criteria:

* History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 2 years.
Androgen Effect on Klinefelter Syndrome Motor Outcome

The purpose of this study is to evaluate the effects of low-dose androgen on the motor and cognitive development of boys with Klinefelter syndrome.

Klinefelter syndrome (KS), a genetic disorder that affects males only, is characterized by having an extra X chromosome. The phenotype - or physical and learning features - includes testicular failure, tall stature, and specific cognitive and behavioral attributes such as diminished motor function, language-based learning difficulties, poor self-image, and shyness. The KS phenotype may be the result of androgen deficiency in utero, infancy, and childhood. For individuals with KS, androgen replacement is standard treatment in adolescence and adulthood but has not been used earlier in childhood or included in the standard medical care of KS children ages 4 to 12.

The purpose of this study is to examine the effects of androgen on learning and development in boys with KS. Researchers also want to determine if low-dose androgen replacement at an early age will improve some of the learning difficulties associated with the disorder. The overall goal of this study is to address questions regarding the relationship of early androgen deficiency to learning and motor function.

Participants in the study will be randomized to one of two treatment groups, receiving either oxandrolone (low-dose androgen) or placebo, for two years. All participants will be evaluated for safety at the beginning of the study and at 3, 6, 12, 18, and 24 months. Also at the beginning of the study and every 3 to 6 months thereafter (for a total of 6 visits), the researchers will perform a careful history and physical examination and a bone age X-ray, and obtain a blood sample.

Participation in the trial will last two years and includes 6 clinic visits.

Eligibility Criteria:
Inclusion Criteria:

* Karyotype diagnosis of Klinefelter syndrome
* Chronological age of 4-12 years
* No treatment with androgen in the past year

Exclusion Criteria:

* Major liver, kidney or other systemic disease
* Variant karyotypes including 47,XYY males
* Evidence of spontaneous onset of puberty, defined as testicular size \> 4ml
the Prognosis of Fetoscopy Treatment of Twin Transfusion Syndrome

Fetal medicine in China is still a new, young discipline, and the development is very rapid. After nearly 10 years of development, the clinical diagnosis and treatment guidelines of some complicated twin diseases has been established. Among them, twin-to-twin-transfusion syndrome (TTTS) is serious disease in twin pregnancy, and the factors affecting prognosis after fetoscopic laser surgery are part of the study. Through this study, the investigators expect to achieve better prediction indicators of the prognosis of TTTS.

A better guideline for twin-to-twin-transfusion syndrome are anticipated to be established in China. Fetoscopic laser surgery is applied to treat TTTS. After surgery, better prediction indicators of the prognosis of TTTS are needed.

Eligibility Criteria:
Inclusion Criteria:

TTTS after fetoscopic laser surgery.

Exclusion Criteria:

Pregnant women who refuse to take part in the study
High Flow Nasal Cannula Therapy for Childhood OSA

The main objective of this study is to evaluate the efficacy of high-flow nasal cannula (HFNC) therapy in children with OSA.

Children and adolescents aged 6 to 18 years old with a diagnosis of moderate-to-severe OSA requiring CPAP therapy will be recruited.

In phase 1 study, eligible subject will be recruited for HFNC therapy titration with PSG to assess treatment efficacy. After titration, if HFNC therapy is shown to be effective, the participants will be recruited into the phase 2 intervention period to evaluate the compliance and quality of life with HFNC therapy. At baseline and follow-up visits, neurobehavioural and quality of life surveys will be completed, compliance data will be obtained.

Background: Obstructive sleep apnoea (OSA) is prevalent in school-aged children and is associated with significant morbidities. Poor compliance with positive airway pressure therapy remains an issue and leads to suboptimal treatment in children with OSA. Alternative therapeutic strategy is needed to manage this group of patients more effectively.

Objective: To evaluate the efficacy of high-flow nasal cannula (HFNC) therapy in children with OSA.

Hypothesis: The investigators hypothesize that HFNC therapy is effective in reducing the severity of OSA in children.

Design: A 2-phase study - phase 1 is a single arm study to evaluate the efficacy of HFNC therapy in children with OSA, phase 2 is an intervention period to evaluate the compliance and quality of life with HFNC therapy.

Subjects: 46 children and adolescents aged 6 to 18 years old with a diagnosis of moderate-to-severe OSA requiring CPAP therapy.

Methods: In phase 1 study, eligible subject will be recruited for HFNC therapy titration with PSG to assess treatment efficacy. After titration, if HFNC therapy is shown to be effective, the participants will be recruited into the phase 2 intervention period to evaluate the compliance and quality of life with HFNC therapy. At baseline and follow-up visits, neurobehavioural and quality of life surveys will be completed, compliance data will be obtained.

Primary outcome measure: Efficacy of the HFNC therapy, as defined by the change in OAHI from baseline to that with HFNC therapy.

Expected results: Efficacy data to determine whether HFNC therapy can be an alternative therapy for children with OSA.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate-to-severe OSA requiring CPAP therapy (Moderate-to-severe OSA is defined as an OAHI ≥ 5 events per hour and reported history of habitual snoring of 3 nights or more per week)

Exclusion Criteria:

* Syndromal diseases;
* Cranio-facial anomalies;
* Pathological central apnoea, chronic respiratory failure or neuromuscular disease as they would require bilevel PAP;
* Secondary obesity e.g. Prader-Willi syndrome, Cushing's syndrome;
* History of pneumothorax or pneumomediastinum;
* Prior use of PAP or HFNC therapy;
* Refusal to use non-invasive ventilation.
The Effect Of Plyometric Training On Balance And Proprioception In Different Branches Athletes

The aim of this study is to investigate the effect of plyometric training on balance and proprioception in athletes in different branches.

54 athletes participated in the study. Two groups were included as 27 athletics and 27 karate groups. Plyometric training was applied to the athletes participating in our study, 2 days a week for 6 weeks, after 20 minutes of warming up and stretching movements before each training. Sociodemographic characteristics of the athletes were recorded. Dynamic balance Y balance test and static balance Stroke balance test; sense of proprioception was evaluated with Angle reproduction test.


Eligibility Criteria:
Inclusion Criteria:

* Being a licensed athlete in the province of Tokat
* Being an athlete who trains regularly
* To be healthy, between the ages of 12 and 18
* Volunteering to work.

Exclusion Criteria:

* Presence of any disturbance that may affect balance and balance reactions,
* Musculoskeletal injury in the last 6 months,
* Presence of previous musculoskeletal surgery,
* Pregnancy,
* Having an acute or chronic illness or injury that will limit performance in training or a match,
* Calcification or other bone and joint problems,
* Using cigarettes, alcohol, and drugs that affect balance.
Triamcinolone Ketorolac (TriKe) Knee Trial

Cortisone injections are commonly used in the treatment of osteoarthrosis of the knee, but there are known detriments to cortisone including localized tissue atrophy near the injection site and acceleration of joint degeneration, as well as contraindications, such as uncontrolled diabetes. Ketorolac is a non-steroidal anti-inflammatory with decades of clinical data that is most commonly injected intramuscularly. There is rising interest in using ketorolac as an intra-articular injectant substitute or adjunctive to cortisone. This may potentially improve clinical outcomes or decrease adverse effects. Although intra-articular use of ketorolac is increasing in orthopedics and sports medicine, there is limited data in the literature comparing these two injectants in prospective, randomized trials, and no data that evaluates combining the two injectants. Primary objectives are to evaluate the efficacy of intra-articular ketorolac compared to cortisone on knee osteoarthrosis and to evaluate whether the combination of ketorolac and cortisone is superior to either alone.

Charts will be prescreened for diagnosis or suspicion of osteoarthritis of the knee by the study staff. Those charts identified will be flagged for possible inclusion in the study. The receptionist will give the prospective subject a copy of the consent to read while they are in the waiting room. Once they are taken back to the room, the investigator will review the study with them. If they are agreeable, they will sign the consent and a copy will be given to them and a copy will be scanned into the Electronic Medical Record (EMR). The investigator will then notify the unblinded investigator, who will randomize the subject and prepare the medication in a blinded fashion. The subject will receive either ketorolac 30 mg, triamcinolone 40 mg, or a combination of the two medications as a one-time injection into the affected knee joint/s. The subject will be asked to complete a survey prior to receiving the injection, and again at 1 week, 6 weeks, and 12 weeks post injection. If necessary, an additional survey will be completed at 24 weeks post injection.

Eligibility Criteria:
Inclusion Criteria:

* Knee pain with diagnosis of osteoarthritis/osteoarthrosis
* Weight-bearing x-rays within the last year adequate to assess Kellgran-Lawrence OA stage
* Age \> 21
* English proficiency sufficient to complete surveys
* Willing to complete follow-up surveys

Exclusion Criteria:

* Prior knee injection in last 3 months
* Knee surgery within the last year
* Contraindications to Cortisone, Ketorolac, or local anesthetic
* Uncontrolled diabetes
* Systemic steroid use in last 3 months
* BMI \> 50
* Non-ambulatory
* Known kidney disease
* Current opioid use
Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug).

The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.


Eligibility Criteria:
Inclusion Criteria:

* For MAIN period (NN5401-3590):
* Diagnosis of type 2 diabetes mellitus for at least 6 months
* Insulin naïve subjects
* Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
* Glycosylated haemoglobin (HbA1c) between 7.5 - 11.0% (both inclusive)
* Body Mass Index (BMI) no higher than 40.0 kg/m\^2
* For EXTENSION period (NN5401-3726):
* Informed consent obtained before any trial-related activities
* Must have completed the 26-week treatment period (visit 28) in trial NN5401-3590

Exclusion Criteria:

* For MAIN period (NN5401-3590):
* Treatment with glucagon like peptide-1 (GLP-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
* Cardiovascular disease diagnosed within 6 months before trial start
* For EXTENSION period (NN5401-3726):
* Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, Monoamine oxidase (MAO) inhibitors
* Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements