cyrilzakka/clinical-trials huggingface dataset:
The Effect of Magnesium Use in Reversal of Neuromuscular Block With Sugammadex

Magnesium therapy used for seizure prophylaxis in patients with preeclampsia. Magnesium has been shown to prolong the effect of nondepolarizing neuromuscular blocking agents (NMBA) and neostigmine used to reverse the effect of NMBA in general anesthesia . In this study, the investigators aimed to evaluate time from sugammadex injection to Train-of-four ratio 0.9 who receieved magnesium therapy in reversing the effect of neuromuscular blocking agent during the recovery period and the relationship between magnesium level and duration of action of sugammadex

Rapid-onset and short-acting agents should be preferred in induction, and full induction doses should be applied since they do not receive premedication and increased volume of distribution. Rapid serial induction and intubation should be performed in pregnancies greater than 20 weeks due to the risk of aspiration. Magnesium potentiates and prolongs the effect of nondepolarizing neuromuscular blocking agents. It is recommended that the TOF value be between 0 and 2 for adequate muscle relaxation in cesarean section anesthesia. In anesthesia induction; thiopental 3-6mg/kg, rocuronium 1mg/kg, and fentanyl 1mcg/kg and dormicum 2mg will administered after the baby birth. Sevoflurane 2-3% and 50% oxygen + 50% air are used for maintenance. If TOF is 0, sugammadex 4mg/kg will be administered to reverse the effect of the muscle relaxant.A blood sample will be taken to measure simultaneous calcium and magnesium values. Patients with a TOF ≥0.9 (gold standard for extubation) or patients will be clinically evaluated and the decision to extubate will be made.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who are scheduled for cesarean section under general anesthesia (pregnant women who do not use magnesium) and who use magnesium for prophylaxis in preeclampsia.

Exclusion Criteria:

* Eclampsia,
* chronic hypertension,
* connective tissue disorder,
* muscle disease, neurological problems,
* thyroid dysfunction,
* kidney disease, heart disease,
* patients with severe allergic reaction to the agents to be used,
* sepsis,
* hypovolemia, abruptio placenta, placenta previa,
* conditions that will prolong the effect of muscle relaxants (drug use ),
* pregnant women who did not want to be included in the study
A Study of ADX-102 in Subjects With Allergic Conjunctivitis

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102 Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age of either gender and any race
* have a positive history of ocular allergies and a positive skin test reaction to a seasonal (grasses, ragweed, and/or trees) or perennial allergen (cat dander, dog dander, dust mites, cockroach) as confirmed by an allergic skin test within the past 24 months
* have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart

Exclusion Criteria:

* have known contraindications or sensitivities to the use of the investigational product or any of its components
* have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye)
* have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past six (6) months
* have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
* have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit
* be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the study duration and for 14 days prior to the installation of investigational product, or has a positive urine pregnancy test at Visit 1
Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury

Purpose: To evaluate the efficacy and safety of levetiracetam on chronic neuropathic pain after spinal cord injury, and to examine its effect on spasms and evoked pain.

Study design: Randomized double-blind cross-over study of levetiracetam (Keppra) against corresponding placebo with a 1 week baseline period followed by 2 x 5 weeks treatment periods separated by a 1 week wash-out period.

Methodology: Levetiracetam and corresponding placebo is gradually increased during two weeks from 500 mg x 2 daily to 1500 mg x 2 daily (1000 mg x 2 daily is allowed if 1500 mg x 2 is not tolerated), and kept on that dose for three weeks.

The study will be monitored by the GCP units of Aarhus and Copenhagen University.

Eligibility Criteria:
Inclusion Criteria:

* 1. age 18 or more
* 2. neuropathic pain (that have lasted at least 3 month) after a spinal cord injury with a pain intensity of at least 4 on a 0-10 point numeric rating scale

Exclusion Criteria:

* 1. pregnancy or lactation
* 2. allergy to levetiracetam
* 3. alcohol or substance abuse, mental disease, epilepsy, depression and psychiatric disorders, severe liver disease, decreased kidney function, and known concomitant cerebral damage
Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women

To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD insertion pain and the difficulty in inserting the IUD in multiparous overweight and obese women

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility Criteria:
Inclusion Criteria:

* multi parous women requesting copper IUD insertion
* body mass index more than 25

Exclusion Criteria:

* pregnancy,
* null parous women,
* contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion,
* untreated active cervicitis or vaginitis,
* undiagnosed abnormal uterine bleeding
Design and Application of Nasal Stents

Comparative study of nasal stents and nasal packing in patients undergoing septoplasty

To investigate the safety and effectiveness of nasal stent in clinical application by comparing and observing the clinical effect and comfort of nasal stent and merocel sponge applied in nasal septoplasty. Methods: patients with nasal septal deviation were selected and randomly divided into nasal stent group (experimental group) and merocel sponge group (control group) according to the packing method. The hemostasis effect, comfort and complications of the two groups were compared during the packing period.

Eligibility Criteria:
Inclusion Criteria:

1. The subjects voluntarily participate in the experiment and sign the informed consent;
2. Age range from 18 to 70 years old, gender unlimited;
3. With nasal congestion as the chief complaint, CT of sinus suggested deviation of nasal septum with indications of surgery (deviation of nasal septum affects breathing and nasal congestion is serious; High nasal septum deviation affects sinus drainage or causes reflex headache; Nasal septum spine often causes nasal bleeding; Nasal septum deviation affects eustachian tube function);
4. No history of respiratory tract infection and nasal decongestant use within 1 month before the visit;
5. No other treatment was used;
6. ASA grade 1\~2;
7. Able to communicate well with researchers and follow the requirements of the experiment.

Exclusion Criteria:

1. There are acute and chronic rhinosinusitis, nasal polyps, benign and malignant tumors and other nasal diseases;
2. History of craniocerebral and nasal surgery;
3. The results of preoperative coagulation function test exceeded 20% of the upper limit of normal value;
4. Patients known to be allergic to test instrument materials;
5. Pregnant or lactating women;
6. Other organoplastic or functional diseases complicated by the subjects limited their participation in the study and could not comply with the follow-up or affect the scientific integrity of the study;
7. Participants who have participated in other clinical trials within the last 1 month;
8. Participants considered unsuitable for this clinical trial for other reasons.
Dose-adjusted EPOCH-R in MYC Positive DLBCL

The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.

The prognosis of MYC positive diffuse large B-cell lymphoma (DLBCL) is very poor even treated with R-CHOP regimen. Recently, dose-adjusted EPOCH-R was shown to be effective in patients with DLBCL and relapsed/refractory Burkitt lymphoma. The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated MYC positive diffuse large B-cell lymphoma
* Age range 18-70 years old
* Eastern Cooperative Oncology Group performance status 0-2
* Life expectancy of more than 3 months
* Adequate organ function

Exclusion Criteria:

* Primary or secondary central nervous system involvement
* Previous serious cardiac disease
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
The Hemodynamic Effects During Sustained Low-efficiency Dialysis Versus Continuous Veno-venous Hemofiltration for Patients With Intracranial Hypertension in a Cross Over Study

Hemodynamic instability occurs frequently during dialysis treatment and still remains as significant cause of patient mobility and mortality. Postoperative hemodynamic optimization has been proved to reduce morbidity in high-risk patients. Intracranial pressure increased can lead to further structural and functional impairment owing to its deleterious effect on the compromised microcirculation and metabolism. This study was to compare the intra-cerebral pressure (ICP) and hemodynamic parameters between the sustained low-efficiency dialysis (SLED) and continuous veno-venous hemofiltration (CVVH) in post- brain tramatic patients.

Patients and Methods This study was based on a clinical cohort study of the renal failure patients in the database of the National Taiwan University Surgical ICU Acute Renal Failure (NSARF) Study Group17-21, with the approval of the Institutional Review Board of the National Taiwan University Hospital (201107015RC).

Study protocol

The inclusion criteria were end stage renal disease (ESRD) patients with increased ICP status post ICP monitor insertion. We started the study after the hemodynamic stable and acceptable ICP less than 20mmHg22. The ESRD patients with active brain hemorrhage, cardiac arrhythmia during dialysis, residual urine output, with inotropic equivalent more than 15 were excluded.

All the patients were ventilated in supine position in controlled-volume mode after stable from brain hemorrhage. During data collection, supportive therapies, ventilatory settings and vasopressor therapy were kept unchanged. Patients were randomized to receive CVVH or SLED and the next day on the other. The ICP monitor was equipped and the indwelling radial artery catheter connected to the FloTrac/Vigileo hemodynamic monitoring system and for whom the ultrafiltration rate was set around 1.0 kg/8hr to 1.5 kg/8hr according to fluid status. Ultrafiltration rate and sodium concentration were fixed during each session.

Clinical assessment The biochemical parameters were measured using the Toshiba TBA-200FR Clinical Chemistry Analyzer (Toshiba, Tochigi-Ken, Japan). When multiple daily measurements were performed, the data obtained closest to 8:00 AM were analyzed 23. The baseline hemodynamic was defined as average of two hours prior dialysis in each dialysis sessions.

Eligibility Criteria:
Inclusion Criteria:

* end-stage kidney disease with anuria status post ICP monitor insertion received

Exclusion Criteria:

* acute dialysis patients
* end-stage kidney disease with uria
The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement

The use of dobutamine in postoperative hemodynamic treatment is widespread despite seemingly intact contraction of the heart. This study aims to elucidate the efficacy of low-dose dobutamine infusion in patients in the postoperative phase replacement of the aortic valve.


Eligibility Criteria:
Inclusion Criteria:

* 18-90 years
* Left ventricular posterior wall =/\>12mm
* Ejection fraction \> 45%
* Sinus rhythm
* Eligible for aortic valve replacement

Exclusion Criteria:

* Need for concomitant cardiac bypass operation.
* Moderate or severe insufficiency of the mitral valve
* Active endocarditis
* Insufficient ultrasound window
* Using B-blockers
* Liver insufficiency
* Patients treated with COMT-inhibitors
* Allergy towards dobutamine
* Pregnancy
* Women of fertile age who do not use relevant anti-conception
* Lacking participant consent
A Prospective Study Evaluating The Utility of Transnasal Endoscopy With Roux en Y Gastric Bypass

Improvements in imaging technology have allowed for the development of small endoscopes ("slim scopes") half the size of a typical endoscope. These small endoscopes can be passed transnasally into the esophagus and stomach with only local anesthesia to the nasal passage without the need for deep sedation. They have been used in the detection of diseases of the esophagus and stomach,3,4 but have not been used in the detection of complications in the post bariatric population

Obesity is an epidemic in the United States effecting 250 million people worldwide and over 30% of the population of the United Sates. Medical therapy for obesity is lacking in its durability in maintaining weight loss. Currently surgical therapy is the most dependable and durable treatment option. The Roux en Y gastric bypass (RYGB) was initially described in 1967 and is currently the surgical method of choice in the treatment of obesity. It involves the creation of a small gastric pouch by restricting the gastric body and antrum and the creation of a long roux limb with a gastrojejunal anastomosis, thus inducing satiety and creating a malabsorptive physiology. Unfortunately this procedure maintains a significant complication rate. Strictures at the gastrojejunal anastomosis occur in 6-20% of patients after bypass.1 Anastomotic ulcers occur in up to 16% .2 Symptoms include vomiting, abdominal pain, and significant nausea. Unfortunately these symptoms are not specific to strictures or ulcers and may occur spontaneously without a specific etiology, so often a transoral upper endoscopy (EGD) is required to evaluate the anastomosis for significant pathology.

EGD in post bariatric patients is a safe procedure. However it typically requires deep sedation administered by an anesthesiologist to overcome the patient's gag reflex and discomfort. Sedation in obese patients can be challenging due to the risks of apnea and challenges of tracheal intubation. For the procedure to be performed the patient must take the day off from work and bring a driver to take them home, thus there are significant direct and indirect costs to the procedure.

Improvements in imaging technology have allowed for the development of small endoscopes ("slim scopes") half the size of a typical endoscope. These small endoscopes can be passed transnasally into the esophagus and stomach with only local anesthesia to the nasal passage without the need for deep sedation. They have been used in the detection of diseases of the esophagus and stomach,3,4 but have not been used in the detection of complications in the post bariatric population

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be able to review and sign informed consent
* Subjects have undergone Roux en Y gastric bypass
* Subjects report any of the following symptoms that would prompt investigation and referral for an upper endoscopy; abdominal pain, nausea, vomiting or problems swallowing

Exclusion Criteria:

* Patients who cannot give and sign informed consent.
A Randomized Controlled Study of Ablation Pursuing Atrial Fibrillation Termination as a Procedural Endpoint in Patients With Persistent Atrial Fibrillation

This is a prospective, randomized, multi-center trial that aims to investigate whether termination of atrial fibrillation can be used as an ablation endpoint for persistent atrial fibrillation (PersAF). Eligible patients who provided consent were randomly assigned to one of two groups: the AF-termination group (whose ablation endpoint was the pursuit of AF-termination) or the prespecified-ablation group (whose ablation endpoint was prespecified ablation followed by electrical cardioversion).


Eligibility Criteria:
Inclusion Criteria:

1. . Age 18-80 years old.
2. . Patients undergoing a first-time ablation procedure for PersAF.
3. . Diagnosed as persistent AF according to the latest clinical guidelines.
4. . Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment.
5. . Patients must be able and willing to provide written informed consent to participate in this study.

Exclusion Criteria:

1. . Uncontrolled congestive heart failure;
2. . History of severe valve disease and/or prosthetic valve replacement;
3. . Myocardial infarction or stroke within 6 months;
4. . Severe congenital heart disease;
5. . EF \<35%;
6. . Contrast agent allergy;
7. . The use of anticoagulant drugs is contraindicated;
8. . Severe lung disease;
9. . Left atrial thrombus confirmed by preoperative esophageal ultrasound;
10. . Contraindications for cardiac catheterization;
11. . Prior left atrial ablation (surgical or catheter);
12. . Have performed any cardiac surgery within 2 months;
13. . Poor general health;
14. . Life expectancy \< 12 months.
Accuracy of Anthropometric Equations to Estimate DXA-Derived Skeletal Muscle Mass in Professional Male Soccer Players

This study aimed to analyze the accuracy of different anthropometric equations to estimate skeletal muscle mass in professional male soccer players, setting dual-energy x-ray absorptiometry (DXA) skeletal muscle mass as the reference.

The study consisted of evaluating anthropometric measurements and body composition with DXA in professional male soccer player aged 18 years and older. Standardized and certified personnel carried out anthropometric measurements and DXA whole body scan the same day.

Skeletal muscle mass was estimated with several anthropometric equations. The reference skeletal muscle mass was obtained assessing appendicular lean soft tissue from a whole-body DXA scan and then transformed into skeletal muscle mass with Kim equation (2002).

The estimated skeletal muscle mass from anthropometric equations was compared with DXA, and those with non-significant differences were further analyzed for calculating mean differences and 95% limits of agreement with DXA. This analysis was carried out for all equations.

Eligibility Criteria:
Inclusion Criteria:

* Signed contract with the team

Exclusion Criteria:

* Injured
Pre-operative Therapy in Breast Cancer

This is a prospective and retrospective study to evaluate the effect of pre-operative therapy on response and survival, and compare the difference in response and survival by pre-operative regimen or by patient's clinicopathological characteristic in early or advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female, Aged ≥18 years
* Histologically confirmed primary breast cancer
* Plan to receive pre-operative therapy
* Adequate organ function

Exclusion Criteria:

* History of neurological or psychological disease, including epilepsy or dementia
* Not suitable to participate in this study judged by investigators
One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass

The aim of this prospective randomized controlled trial is to compare the two procedures One-anastomosis gastric Bypass/Mini-gastric Bypass (OAGB/MGB) and Roux-en Y gastric bypass (RYGB) in relation to intraoperative and postoperative complications (classification of Clavien-Dindo), mortality, metabolic impact (remission of type 2 diabetes mellitus, hypertonus, gastro-esophageal reflux disease, sleep apnea, dyslipidemia, quality of life, operation time, postoperative excess weight loss, malnutrition and re-do/revisonal surgery.

OAGB/MGB is gaining popularity as a primary surgical treatment for morbid obesity due to reduced operation time, a shorter learning curve, better weight loss, higher metabolic impact and fewer major complications compared to RYGB.

In this prospective randomized controlled trial we want to compare OAGB/MGB and RYGB with a FU of up to 24 month.

Patients with indication for gastric bypass get randomized in group A (RYGB, n = 50) or B (OAGB/MGB, n = 50). FU is performed 1, 3, 6, 12 and 24 month after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. primary obesity surgery and indication for gastric bypass
2. age: 18 - 65 years
3. BMI \> 40 kg/m² or BMI \> 35 kg/m² with obesity related comorbidities
4. informed consent

Exclusion Criteria:

1. obesity surgery in the anamnesis
2. visceral surgery in the anamnesis (excluding appendectomy and cholecystectomy)
Assessment of the Efficacy of Tracheal Oxygen Administration During Bronchoscopy - a Phase II Trial

The aim of the present study is to measure the time to correction of O2 saturation when in case of desaturation below 90%, O2 administration is switched from the nasal to the tracheal route at a similar flow rate.

The development of a flexible bronchoscope with a channel dedicated to O2 administration might allow optimization of the oxygen supplementation during bronchoscopy, which reduces the risk of per- and peri-procedural hypoxemia. The investigators will conduct a pilot study corroborating the hypothesis that tracheal supplementation of oxygen during flexible bronchoscopy is advantageous in comparison to nasal cannula supplementation.

The concept of our trial consists of a mono-centric observational study performed in the endoscopy suite of the Respiratory Division, University Hospitals Leuven. All patients will be given informed consent before inclusion.

The aim of the present study is to measure the time to correction of O2 saturation when in case of desaturation below 90%, O2 administration is switched from the nasal to the tracheal route at a similar flow rate.

Eligibility Criteria:
Inclusion Criteria:

* patients referred for flexible bronchoscopy

Exclusion Criteria:

* broncho-alveolar lavage
* endobronchial plugging