cyrilzakka/clinical-trials huggingface dataset:
Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder

The purpose of this study is to determine whether a participation of a medical clown in videofluoroscopic examination of pediatric speech disorder such as velopharyngeal inadequacy, improves the collaboration of the pediatric patient, the patient's and the caregivers subjective experience, and the quality of the examination (shorter exposure to radiation, shorter time at the radiology suite, more accurate parameters retrieved from the imaging results).

Velopharyngeal inadequacy (VPI) results in reduced speech intelligibility and nasopharyngeal regurgitation. VPI is more common in patients who previously underwent cleft palate repair, in craniofacial syndromes such as 22q11.2 deletion syndrome, or in neuromuscular diseases. Part of the work-up sometimes includes videofluoroscopic examination of the palate's movement during speech. This procedure involves ionizing radiation and requires adequate collaboration by the examinee. The examination set-up is foreign to the child and can cause stres and anxiety which can hinder the examination's accuracy and completion. Medical clowns professionalise in stress relieve.

In this prospective controlled study, the study group will be accompanied by a medical clown from the arrival to the premise, through the actual examination and after exiting the exam room. The medical clown will explain about the upcoming examination and will induce a less stressed atmosphere. After the examination the clown will close the session for the patient.

The control group will do the same procedure but without a medical clown. Factors such as pulse, total time in the examination room, net time of exposure to radiation and quality of data will be collected for each patient. The patient (if 7 year old and up) and his caregivers will fill up after completion of the examination a short questionnaire about their experience.

The data will be collected and summarized and then a statistical analysis will be made in order to compare the study group and the control group.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of velo-pharyngeal inadequacy

Exclusion Criteria:

* a patient or caregiver that did not consent to participate in the study
Labor Induction and Maternal BMI, Comparison of Different Pre-induction Cervical Ripening Methods

The purpose of this study is to investigate whether mechanical cervical ripening (using the Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in overweight and obese women undergoing labor induction.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of age or older.
* Diagnosed to be pregnant (al least 37 weeks of gestation) with a medical indication for labor induction, including: postdate pregnancy, preeclampsia, gestational or chronic hypertension, Gestational Diabetes Mellitus at term, Oligohydramnios, Polyhydramnios, fetal growth restriction, maternal background disease necessitating delivery, Isoimmunisation, maternal Thrombophilia, intrahepatic cholestasis of pregnancy.
* Having a Bishop score of 4 points or less.
* Diagnosed as having singleton pregnancy at term (37 weeks at least) in a vertex presentation, with intact membranes, and absence of significant regular uterine contraction.
* Willingness to comply with the protocol for the duration of the study.
* Has agreed and signed an informed consent after given oral and written explanation.

Exclusion Criteria:

* Anay contraindication for a vaginal delivery (i.e. placenta previa, non vertex presentation, estimated fetal weight of less than 4500 gr).
* Ruptured membranes.
* Previous cesarian section or presence of any uterine scar.
* Documented labor with four or more spontanous uterine contractions per hour.
* Suspected fetal distress necessitating immediate intervention.
* Proven malignancy of the cervix.
* Active vaginal bleeding.
* Active inflammatory or purulent condition of the lower genital tract.
* Active asthma.
Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes

This trial is conducted in South Africa, Europe and North America. The aim of this trial is to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4 (DPP-4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs) qualifying for intensified treatment.


Eligibility Criteria:
Inclusion Criteria:

* Insulin naïve subject (allowed are: previous short term insulin treatment up to 14 days; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
* Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling - alpha-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
* HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
* Body Mass Index (BMI) maximum 45.0 kg/m\^2
* Type 2 diabetes (diagnosed clinically) for at least 6 months
* Ability and willingness to adhere to the protocol including performance of self monitored plasma glucose (SMPG) profiles according to the protocol

Exclusion Criteria:

* Use within the last 3 months prior to Visit 1 of: thiazoledinediones (TZDs), exenatide or liraglutide
* Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements \[for UK: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods\]
* Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)
Procedure-to-procedure Transfer Trial

Surgical training programs using virtual reality simulators often only use basic skills training and the use of procedural training is very limited. Procedural training differs from basic skills training by requiring integration of isolated skills and decision making and planning components. However, it is unknown if it is necessary to practice all procedures before operating on actual patients or whether it is simply a matter of learning psychomotor skills and if these skills are transferable between different tasks.

The main hypothesis is that practicing a laparoscopic procedure on a simulator makes it easier to reach proficiency on a different laparoscopic procedure on the simulator because participants have already practiced the integration of isolated skills.


Eligibility Criteria:
Inclusion Criteria:

* Medical students enrolled at The Faculty of Health Science, University of Copenhagen.
* Obtained the bachelor degree in medicine.
* Signed informed consent.

Exclusion Criteria:

* Previous participation in trials involving laparoscopic training.
* Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).
* No informed consent.
* Does not speak Danish on a conversational level.
Retrospective Study of the Linear™ Hip

The purpose of this study is to evaluate the use and efficacy of the Encore Linear™ Hip System in a group of 200 patients for whom data has already been collected.


Eligibility Criteria:
Inclusion Criteria:

* Have hip joint disease related to one or more of the following

  * osteoarthritis
  * rheumatoid arthritis
  * femoral fracture
  * correction of a functional deformity
  * avascular necrosis of the natural femoral head
* Skeletal maturity
* Patient is likely to be available for evaluation for the duration of the study
* Able and willing to sign the informed consent and follow study procedures
* Patient is not pregnant
* No infection present
* No known materials sensitivity
* Patient is over 18 years of age

Exclusion Criteria:

* Skeletal immaturity
* Infection or sepsis
* Insufficient bone quality that may affect the stability of the implant
* Muscular, neurologic or vascular deficiencies which compromise the affected extremity
* Alcoholism or other addictions
* Prisoners
* High levels of physical activity
* Patient is pregnant
* Loss of ligamentous structures
* Materials sensitivity
* Patient is under 18 years of age
Best Practice Using Rocuronium and Reversal With Neostigmine or Sugammadex

This is an estimation study, prospectively evaluating the incidence of postoperative residual neuromuscular blockade (PRNB) when a best practice protocol is implemented for a cohort of abdominal surgery and orthopedic surgery patients. The protocol is developed within the constraint of subjective monitoring, quantitative monitoring is not used, and use of rocuronium for paralysis and either neostigmine or sugammadex for reversal. The primary outcome is the incidence of PRNB on arrival to the post-anesthesia care unit, defined as a train-of-four ration \<0.9.

This study estimates the incidence of postoperative residual neuromuscular block when rocuronium neuromuscular block is managed by protocol for qualitative monitoring and reversal with neostigmine or sugammadex. The study is an extension of the recently published study by Thilen and co-workers which evaluated a protocol which used neostigmine as the sole reversal agent (doi: 10.1016/j.bja.2018.03.029). It demonstrated that use of a protocol was associated with a reduced incidence of severe residual paralysis, defined as normalized train-of-four (TOF) ratio \<0.7 at time of tracheal extubation. It was also associated with a highly significant reduction in PRNB as defined for several secondary outcomes, including non-normalized (i.e. raw) TOF-ratio \<0.9 at time of arrival to the post-anesthesia care unit (PACU).

The current study does not include a control group, only an intervention group. The investigators hypothesize that PRNB can be prevented by adhering to a protocol which incorporates several current recommendations by experts. Importantly, the protocol preserves a role for neostigmine when the pre-reversal assessment indicates that spontaneous recovery has progressed to a so-called minimal block which is defined as the subjective absence of fade in the adductor pollicis TOF response. The investigators will study only abdominal surgery and orthopedic surgery patients. The primary outcome is incidence of PRNB, defined as TOF-ratio \<0.9 on arrival to the PACU. The investigators plan to enroll 120 patients, and if no more than one patient has PRNB, the upper bound for the 95% confidence interval will be less than 5%.

Eligibility Criteria:
Inclusion Criteria: Adult 18 years old or older, Will undergo open or laparoscopic abdominal surgery or orthopedic surgery expected to last \<6 hours at Harborview or Univ of Wash Med Ctr, Have American Society of Anesthesiologists physical status I-III, scheduled to have general anesthesia with at least 1 dose of nondepolarizing neuromuscular blocking drug for endotracheal intubation or intraoperative neuromuscular blockade.

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Exclusion Criteria: Allergy to neuromuscular blocking drugs, patients with neuromuscular disease (myasthenia gravis or muscular dystrophy), pregnant or lactating women, non-English speaking.

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Efficacy and Safety of Intravenous Vitamin K1 in Management of Acute Variceal Bleeding

The administration of Vitamin K1 (Vit-K1) injection is frequently utilized in clinical practice for managing upper gastrointestinal bleeding (UGIB) associated with liver cirrhosis, despite insufficient evidence supporting its effectiveness. This research aimed to assess the safety and efficacy of intravenous Vit-K1 in the management of acute variceal bleeding in cirrhotic patients.

This randomized, open-label clinical trial involved 66 cirrhotic cases with UGIB of suspected variceal origin. The cases were randomly assigned to two groups: one group (n = 33) had a 10 mg intravenous infusion of Vit-K1 daily for three days, while the other group (n = 33) received nothing, along with standard pharmacologic and endoscopic treatments. Endoscopic evaluation confirmed ruptured varices as the cause of bleeding in 59 cases. The primary endpoint was a composite measure that involved (bleeding control, rebleeding prevention, or death).

Adding vitamin K1 to standard-of-care therapy in managing acute variceal bleeding complicating liver cirrhosis showed no advantage over standard-of-care therapy in terms of bleeding control, prevention of rebleeding, or reducing mortality during hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* Active acute upper gastrointestinal bleeding suspected of being of variceal origin (e.g., melena and/or hematemesis within 24 hours before inclusion) and required admission to the ICU.
* Endoscopic confirmation of variceal bleeding, carried out within twelve to twenty-four hours of ICU admission, was defined by either direct visualization of blood from a gastric or esophageal varix or the presence of red color signs on varices along with blood in the stomach or esophagus, with no other identifiable bleeding source.
* Cirrhosis has been confirmed through histology or by clear clinical, endoscopic, or sonographic signs of portal hypertension and cirrhosis.

Exclusion Criteria:

* Known hypersensitivity to Vit-K1.
* Known hypercoagulopathy.
* Recent history (within 6 months) including deep vein thrombosis or pulmonary embolism.
* History of persistent or unstable angina pectoris, portal vein thrombosis, intermittent claudication, myocardial infarction, ischemic stroke, transient ischemic attack.
* Prior parenteral or oral Vit-K1 administration within the previous two weeks.
Comparison of Two Pharmacological Treatments of Pedophilia

Sexual abuse committed on children is a major public health problem because of its frequency and its severe consequences on the mental health of victims.

Objective: to compare the therapeutic efficacy of cyproterone acetate (CPA) and leuprolide, with the hypothesis that leuprolide will be more effective.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of pedophilia
* high frequency of sexual urges and deviant behavior as demonstrated by a score equal to 8 on the scale of Rösler \& Witztum (Rösler \& Witztum, 1998) ;
* age: 18-60 years
* informed consent

Exclusion Criteria:

* IQ\<70
* schizophrenia, schizoaffective disorder, or delusional disorder
* already receiving one of the tested drugs
* contraindication for one of the tested drugs
* no current or planned incarceration
Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle.

Evaluation of ventricular arrhythmias sensing via a left bundle branch area pacing lead.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic or non-ischemic cardiomyopathy
* Left ventricular ejection fraction ≤35% despite optimal medical therapy
* Left bundle branch block with QRS ≥130 milliseconds

Exclusion Criteria:

* Previously implanted intra-cardiac material
Right Ventricle Function After Major Right Lung Resection

Major lung resection is associated with high post-operative morbidity and mortality and significant long-term decreased functional capacity, especially due to cardiorespiratory complications.

RV (Right Ventricle) ejection, pulmonary artery pressure and tone are tightly coupled. The RV is exquisitely sensitive to changes in afterload. When pulmonary vascular reserve is compromised RV ejection may be also compromised, increasing right atrial pressure and limiting maximal cardiac output. Acute increase in RV outflow resistance, as may occur with acute pulmonary embolism will cause acute RV dilatation and, by ventricular interdependence, markedly decreased LV (Left Ventricle) compliance, rapidly spiraling to acute cardiogenic shock and death.

Most of the studies on RV function after lung resection are small and have found different results, and sometimes conflicting findings. As far as the investigators know, there are no data on the incidence of the RV dysfunction after major lung resection (pneumonectomy/bilobectomy) and it's not clear if there is some direct association between the RV dysfunction and post-operative complications. If so, early detection of RV dysfunction after major lung resection could provide the opportunity for interventional therapy with consequent possible improvement of these patients' prognosis.

The aim of this study is to identify the incidence of early RV systolic dysfunction (defined as Tricuspid Annular Plane Systolic Excursion (TAPSE) \< 17 cm, S' (TDI) \< 10 cm/s) and estimate the RV-PA (Right Ventricle-Pulmonary Artery) coupling as indicated by Guazzi et all. (TAPSE/PAPs ratio, where PAPs is the Systolic Pulmonary Artery Pressure) after major lung resection (bilobectomy and pneumonectomy) using echocardiography, and to assess if these modifications (RV dysfunction and RV-PA coupling) may be associated with post-operative cardiopulmonary complications occurring during the hospitalization period. Investigators also intend to evaluate if these changes are associated with impaired functional capacity at 3 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients undergoing right pneumonectomy
* Adults patients undergoing pulmonary bilobectomy

Exclusion Criteria:

* Left pneumonectomy (it will not permit TTE postoperatively)
* Completion pneumonectomy
* Patients suffering from any myocardial disease
* Preceding Pulmonary Embolism
* Pregnancy
* Potential pregnancy
* Patients enrolled into another trial
Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

The purpose of this study was to compare the immediate efficacies of each treatment maneuvers in treatment of geotorpic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).

A randomized prospective study of patients with HC-BPPV. Patients with geotropic type of HC-BPPV were randomized to one of each three treatment groups at their first clinic visit. These groups included the barbecue maneuver, Gufoni's maneuver, and sham group in geotropic HC-BPPV. Responsiveness of treatment maneuver was determined by positioning maneuver immediately after each treatment method based on resolves of vertigo and positional nystagmus.

Eligibility Criteria:
Inclusion Criteria:

* a history of brief episodes of positional vertigo, direction-changing horizontal nystagmus beating toward the uppermost (apogeotropic nystagmus) ear in both the lateral head turning positions,
* no spontaneous nystagmus during upright sitting position
* absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus

Exclusion Criteria:

* central positional nystagmus with identifiable CNS lesions that could explain the positional nystagmus
Efficacy of Dark Chocolate in Achalasia Patients

Flavanols, present in dark chocolate, were shown to induce Nitric Oxide synthesis. Since Nitric Oxide facilitates smooth muscle relaxation, it might ease the relaxation of the LES (lower esophageal sphincter)as well.

The objective of the present study is to evaluate tha efficacy of dark chocolate in improving LES relaxation in achalasia patients.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of "achalasia"
* "Achalasia" diagnosis during manometry at day 1 of the study.

Exclusion Criteria:

* pregnancy
* pseudoachalasia
* consumption of GI-motility modifiers durin 72 hours preceding the study.
4K Versus 3D Total Laparoscopic Bilateral Oophorectomy: Tools in Comparison

Evaluate whether the 4K laparoscopic vision system can provide an advantage in performing bilateral oophorectomy procedures for benign conditions carried out by trainee surgeons compared to 3D laparoscopy

All patients diagnosed with suspected benign ovarian pathology based on preoperative examinations (pelvic Doppler ultrasound and/or magnetic resonance imaging and/or CT scan) and with indication for bilateral laparoscopic adnexectomy will be enrolled in the study. The primary objective of the study is to compare surgical times between the 3D and 4K vision systems in laparoscopic ovarian surgery, specifically in bilateral adnexectomy performed by trainee surgeons. Secondary objectives will include evaluating intra- and postoperative complications, length of hospital stay, and costs to the healthcare system

Eligibility Criteria:
Inclusion Criteria:

* Patients with benign ovarian pathology requiring bilateral oophorectomy
* ASA score \<3
* Patients who have signed the appropriate informed consent
* Patients who are not pregnant or diagnosed with pelvic inflammatory disease
* No history of prior major abdominal surgery

Exclusion Criteria:

* Suspected neoplastic pathology
* Patients not eligible for surgery
Functional MRI and MRA in Migraine With Aura

Patients who report that exposure to bright light or strenuous physical activity will induce migraine aura will be provoked using one or both of these methods. Followingly the patients will be examined by functional MRI. Íf the patients develop migraine headache, MR angiography will be performed as well. The primary study hypothesis is that the functional MRI signal will show features similar to those of the electrophysiological phenomenon of cortical spreading depression.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with migraine with aura as defined by The International Classification of Headache Disorders 2
* Age between 18 and 80 years both inclusive
* Reports that bright light or strenuous physical activity may trigger migraine aura

Exclusion Criteria:

* Contraindications towards exposure to photostimulation or strenuous exercise
* Body weight above 130 kg
* Pregnant or lactating females
* Contraindications towards MRI scanning
* History or clinical signs of: cardiovascular disease, psychiatric disease, substance abuse or any symptom or disease considered relevant by the examining physician.
Evaluation of Chronic Pain After Nerve Section During Thoracotomy

The purpose of this study is to investigate if controlled nerve section reduces chronic pain after thoracotomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients included for anterior or lateral thoracotomy

Exclusion Criteria:

* Unable to give consent due to age, cognitive reduction or otherwise
* Neurological disease or symptoms affection thoracic area
* Chronic pain prior to surgery
* Inability to supply the patient with an epidural catheter
* Pneumonectomy
* Prolonged infection at surgical site
* Invasive tumor growth
* Need for repeated surgery at site