cyrilzakka/clinical-trials huggingface dataset:
Influence of a Single Dose Dexamethasone on the Time Course of Neuromuscular Blockade of Rocuronium

The aim of the present study is to compare the time course of a neuromuscular block in patients receiving dexamethasone 8 mg in order to reduce postoperative nausea or vomiting several hours before surgery with patients receiving the drug immediately before induction of anaesthesia and patients without a dexamethasone prophylaxis. The primary end point is the time from start of injection of rocuronium until recovery to a train of four ratio (TOF ratio) of 0.9.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 to 65 years,
* American Society of Anesthesiologists Physical Status I or II,
* 50-90 kg body weight,
* undergoing elective laparoscopic gynaecological surgery in general anaesthesia necessitating intraoperative neuromuscular blockade.

Exclusion Criteria:

* expected difficulties with endotracheal intubation (history of difficult intubation,
* reduced opening of the mouth (\< 2cm), and Mallampati Score of 4),
* increased risk of pulmonary aspiration (gastrooesophageal reflux, full stomach, intestinal obstruction),
* known allergies to the drugs tested,
* pregnancy,
* neuromuscular disorders,
* intake of drugs affecting neuromuscular blockade, such as furosemide, magnesium or cephalosporins,
* hepatic-or renal insufficiency.
Adjunctive Cilostazol Versus High Maintenance-dose Clopidogrel According to Cytochrome 2C19 Polymorphism

The purpose of this study is to determine the impact of adjunctive cilostazol versus high maintenance-dose clopidogrel on platelet inhibition in carriers and non-carriers of the loss-of-function CYP2C19 mutant allele.

The additional platelet inhibition with clopidogrel, a thienopyridine inhibitor of the platelet P2Y12 adenosine diphosphate (ADP) receptor, has reduced the risk of ischemic events after coronary stent implantation. Because of inter-individual variability in platelet response to clopidogrel, a significant proportion of suboptimal platelet inhibition has been reported. In addition, persistent residual platelet reactivity measured with platelet function testing has shown the association with the cardiovascular outcomes after percutaneous coronary intervention (PCI).

Various clinical factors and genetic polymorphisms have been studied to predict the degree of antiplatelet response to clopidogrel. Interestingly, recent studies found that carriers of the loss-of-function hepatic cytochrome (CYP) 2C19 allele had significantly lower levels of the active metabolite of clopidogrel, diminished platelet inhibition, and a higher rate of major adverse cardiovascular events than did non-carriers, in the setting of PCI and acute coronary syndrome (ACS). These findings raise the need of solutions to overcome enhanced post-clopidogrel platelet reactivity by the influence of the loss-of-function CYP2C19 allele. Increasing the dose of clopidogrel and new potent P2Y12 antagonists (such as prasugrel) may be alternative antiplatelet regimens in patients with the loss-of-function CYP variant.

Cilostazol reversibly induces platelet inhibition via its blockade of phosphodiesterase (PDE) type 3 and is catalysed mainly by CYP3A. A recent study demonstrated that adjunctive cilostazol to dual antiplatelet therapy (triple antiplatelet therapy) intensified platelet inhibition as compared with a high maintenance-dose (MD) of 150 mg/day. Therefore, triple antiplatelet therapy could also be an alternative antiplatelet therapy to improve platelet inhibition and clinical outcomes in carriers of CYP2C19 mutant allele.

We compared the enhanced inhibition of platelet aggregation by adjunctive cilostazol 100 mg twice daily versus high-MD clopidogrel 150 mg/day in patients treated with elective coronary stenting, according to the CYP2C19 polymorphism.

Eligibility Criteria:
Inclusion Criteria:

* Significant coronary artery stenosis (\>70% by visual estimate)
* Elective coronary stent implantation

Exclusion Criteria:

* Acute myocardial infarction
* Active bleeding and bleeding diatheses
* Hemodynamic instability
* Oral anticoagulation therapy with warfarin
* Use of peri-procedural glycoprotein IIb/IIIa inhibitors
* Contraindication to antiplatelet therapy
* Left ventricular ejection fraction \< 30%
* Leukocyte count \< 3,000/mm3, platelet count \< 100,000/mm3, AST or ALT ≥ 3 times upper normal
* Serum creatinine level ≥ 3 mg/dL
* Stroke within 3 months
* Noncardiac disease with a life expectancy \< 1 year
* Inability to follow the protocol
Study of Gammacore Sapphire for the Acute and Preventive Treatment of Post-Traumatic Headache (GAP-PTH)

The purpose of this single-center, prospective, randomized, double-blind, sham controlled, parallel-group study is to collect clinical data related to the safety and efficacy of vagus nerve stimulation for the acute and preventive treatment of Post Traumatic Headache.

The study will enroll 60 subjects over a period of 14 weeks each. Subjects will use either a sham or active device to treat acute Post Traumatic Headache. Investigators will collect clinical data related to the use of the device.

Eligibility Criteria:
Inclusion Criteria:

1. Meets the ICHD-3 criteria for acute headache attributed to mild traumatic injury to the head
2. Experiences a minimum of 2 headaches (migraine or probable migraine phenotype) per week
3. Presentation to clinic between 2 and 4 weeks after injury
4. Able to provide written informed consent

Exclusion Criteria:

1. Any pre-existing primary headache disorder (with the exception of infrequent episodic tension type headache)
2. Any contraindication to using nVNS
3. Initiation or change in the dosage of any medication commonly used or headache prophylaxis 3 months before enrollment into the study
4. Continuous headache at the time of enrollment
5. PTH \>4 weeks after injury
6. Structural abnormality at the nVNS treatment site (e.g., lymphadenopathy, previous surgery, abnormal anatomy)
7. Pain at the nVNS treatment site (e.g., dysesthesia, neuralgia, cervicalgia)
8. Other significant pain problem (e.g., cancer pain, fibromyalgia, other head or facial pain disorder) that, in the opinion of the Investigator, may confound the study assessments
9. Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure) or an abnormal baseline electrocardiogram (ECG) within the last year (e.g., second- or third-degree heart block, prolonged QT interval, atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation, clinically significant premature ventricular contraction)
10. Known or suspected cerebrovascular disease (e.g., prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery)
11. Previous cervical vagotomy
12. A relative of or an employee of the Investigator or the clinical study site
13. Previously used gammaCore
Familiy Medicine Perspective to Maternal-infant Bonding

Maternal bonding was described as a qualitative change in the relationship of a mother with her infant. By this study, the investigators aimed to investigate the mother-infant bonding and the factors affecting it, from the point of the family practice, which is responsible for the healthcare of all family members from the fetus to the eldest individual in a family.

The study was carried out as a single-centered descriptive research among 73 women at the postpartum period. The sociodemographic status and the histories of pregnancies of the study participants were recorded. The Maternal Attachment Inventory (MAI), which questions the biological, psychological and social factors, and the Hospital Anxiety and Depression Scale (HADS) were used to collect data to determine the factors affecting the mother-infant bonding in the postpartum period.

The study is a descriptive survey study, which was conducted to determine the mother-infant attachment and its affecting factors in mothers in the first 6-week of the postpartum period. In order to conduct the study, the local Ethics Committee approval was obtained. (Approval date: 24.11.2016, number 18517).

The mean score of the Turkish version of the Maternal Attachment Inventory (MAI) is approximately 95+6 according to the validation study. In our study, considering that the average MAI score of the participants would be approximately 97, investigators determined to include 73 patients in the study with a type I error set at a=0.05 and with the power of (1-b) 80%.

The universe of the study consists of the mothers in the first 6 weeks of the postpartum period presenting to the Obstetrics and Gynecology Clinic and the mothers of the pediatric patients presenting to the Pediatric Clinic of the Health Sciences University Umraniye Education and Research Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Women who gave birth in 6 weeks
* Women who had no mental illness history
* Women who had no health issue
* Women who accepted to join the study
* Women who can communicate

Exclusion Criteria:

* The women who did not have the features below the inclusion criteria
In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With Chronic Illness

This study will seek to compare the effect of a mindfulness meditation program for adolescents with chronic illness delivered either in person or via an online platform. The 8-week program will combine meditation practices, breathing exercises and group discussions. Participants will be recruited from different general and specialized clinics at the Hospital for Sick Children and will be allocated to either an in-person or the online group through a random process (like tossing a coin). The study will aim to recruit 60 participants ages 13-18. Each participant will provide data through research questionnaires, recorded interviews and saliva samples.

The study will be conducted as a longitudinal randomized controlled trial comparing in-person and eHealth delivery of a mindfulness meditation intervention for adolescents with chronic illness. There will be two arms. An experimental and a feasibility arm. In the experimental arm, 4 groups of 10-15 participants will be formed: two in-person groups (early and late) and two eHealth groups (early and late). The early groups will receive the intervention at the beginning of the study period and the late groups will be wait-list controlled group that will receive the intervention at the middle of the study period. At the end of the recruitment period or when the target number of participants is met (60), whichever comes first, all teens meeting the inclusion criteria will be randomly allocated to one of the four randomized groups. Teens who are not meeting the final inclusion criteria (able to attend mindfulness sessions at Sickkids) will be offered a spot in the feasibility arm of the study until the maximum total number of study participants is reached (60). These participants will be placed in eHealth groups (either early or late) through a separate randomization process.

Data collection will take place at baseline (during the intake meeting), immediately before and following the mindfulness intervention as well as at the end of the 6-month study period. Participants in the experimental arm will provide data through research questionnaires, salivary cortisol analysis as well as individual semi-structured interviews with a research assistant. Salivary samples will be provided from home for participants in the eHealth groups. Participants in the feasibility arm will only provide information through research questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic illness
* Fluent in English
* Followed by a care provider at the Hospital for SickKids
* Able to consent to the study
* Able to attend in-person mindfulness meditation sessions at Sickkids (for the experimental arm only)

Exclusion Criteria:

* Active and unaddressed suicidal ideation
* Developmental disability preventing participation in the mindfulness program
Novel Adjuvants for Peptide-Based Melanoma Vaccines

This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's adjuvant (IFA) with or without interleukin-12 in patients with resected stage III or IV melanoma.

In the Phase I/II trial, patients with resected stages III and IV melanoma who have been rendered free of disease, but are at high risk of relapse, are treated with peptides/IFA at a dose of 0.5 mg each peptide plus CTLA-4 antibody given intravenously, 3 mg/kg, after each vaccination. In the Phase II randomized study, patients are treated with the melanoma peptide vaccine alone, with CTLA-4 antibody, or with CTLA-4 antibody combined with IL-12 at 30 ng/kg with alum. The peptides are tyrosinase 368-376 (370D); gp100 209-217 (210M); and MART-1 26-35 (27L) which are emulsified with IFA. The dosing schedule for both trials are at 1, 2, 3, 4, 5, and 6 months; then at 9 and 12 for a total of 8 vaccinations.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of stage III or IV cutaneous, mucosal, or ocular melanoma
* Completely resected disease or disease-free
* HLA-A2.1 positive
* Tumor tissue available for immunohistochemical analysis and staining positive for at least 1 of the specified antigens
* At least 1 month since prior therapy for cancer, including radiotherapy and adjuvant therapy
* WBC count at least 3,000/mm3
* Granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 9.0 gm/dL
* Creatinine no greater than 2.0 mg/dL
* Bilirubin no greater than 2.0 mg/dL
* SGOT/SGPT no greater than 2.5 times upper limit of normal
* ECOG performance status 0-1
* Have failed alpha-interferons (patients with resected stage III disease)

Exclusion criteria:

* Prior treatment with tyrosinase: 368-376(370D), gp100:209-217(210M), and MART-1:26-35(27L) peptides
* Steroid therapy or other immunosuppressive medication requirement
* Major systemic infections (e.g., pneumonia or sepsis)
* Coagulation or bleeding disorders
* Major medical illnesses of the gastrointestinal, cardiovascular, or respiratory systems
* Allergic reaction to Montanide ISA 51 (incomplete Freund's adjuvant)
* History of uveitis or autoimmune inflammatory eye disease
* Other active autoimmune disease
* Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody
* Pregnant or nursing
Assessment of the Effectiveness of Biodentine® in Pulpotomies Primary Teeth

Clinical and radiographic assessment of Biodentine® as a pulp dressing material for pulpotomy treatment in human primary molars.


Eligibility Criteria:
Inclusion Criteria:

* one or more primary teeth which requires pulpotomy.

Exclusion Criteria:

* not healthy patients,
* patients with teeth which requires pulpectomy.
Augmenting Exposure Therapy With an N-Methyl-D-Aspartate (NMDA) Agonist for Panic Disorder

This study involves cognitive behavioral therapy (CBT) and a medication called D-cycloserine (DCS), which is thought to help reduce panic symptoms more effectively by interacting with N-methyl-D-aspartate (NMDA) glutamate receptors, facilitating many forms of learning including the extinction of fear. Participants will be randomly assigned (like flipping a coin) to receive either DCS or a placebo in addition to CBT.

This study consists of cognitive behavioral therapy (CBT) including exposure to physical sensations and feared situations, which have been demonstrated to be effective for many individuals with panic disorder.

All assessments and treatment sessions are free of charge. Half of the patients will be randomly assigned to receive D-cycloserine (DCS) and half wll be assigned to receive a placebo. Although DCS is used in humans to treat tuberculosis, it has not been FDA approved for this indication. Recent research in other anxiety disorders has shown that DCS plus behavior therapy is more effective than behavior therapy alone.

This treatment study had two active interventions. All patients will receive CBT and the researchers expect that everybody will improve from this treatment. However, it may be that those patients in the DCS intervention will improve somewhat more than those in the placebo intervention.

The treatment will be structured with at home practice and repeated assessments. Assessments are extremely important as they guide the treatment and provide the study investigators necessary information about the treatment. The treatment consists of 5 sessions (once a week) plus a one week post-treatment assessment and follow-up assessments at one month and six months.

Eligibility Criteria:
Inclusion Criteria:

* Principal diagnosis of panic disorder

Exclusion Criteria:

* History of psychotic disorders or bipolar disorder
* Substance dependence
* Pregnant or breastfeeding
* History of a medical condition that may increase the risks of taking the study drug
Performance Anxiety Changes With Exercise

This study investigates the effect of high-intense aerobe exercise training (HIIT) and aerobe exercise of low intensity on clinical and physiological parameters (anxiety, activity, cortisol, alpha amylase, heart rate, heart rate variability, spiroergometry) in patients with Music Performance Anxiety (MPA). Half of the patients will receive HIIT, while the other half will receive aerobe exercise of low intensity.

In this study, 20 patients with MPA will receive a high-intensive aerobe training (HIIT, 6 HIIT-sessions of 20 minutes within a period of 12 days). Additionally, 20 MPA-patients will undergo a less intense aerobe training matched regarding frequency and duration of sessions. Prior to the first training session, after completing the training (day 12) and 10 days after the Training (day 22), symptoms of anxiety and will be assessed by using questionnaires. Moreover, heart rate and heart rate variability will be obtained and activity level is measured using accelerometers. Before and after the training there will be an assessment of saliva samples for measuring cortisol and alpha amylase.

Furthermore, a standardized performance situation is established before and after the Training. Before, during and after the performance anxiety ratings, cortisol, alpha amylase, heart rate and heart rate variability are assessed.

The investigators hypothesize, that patients with MPA which undergo HIIT, will show a stronger and more sustained improvement of both, clinical symptoms and physiological measures. Specifically, a decreased heart rate, higher heart rate variability and decreased endocrinological parameters.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of social anxiety disorder, Performance only subtype due to DSM-5
* Appropriate abilities to communicate and to complete the questionnaires
* Written informed consent
* Possibility of regular attendance at the training sessions
* Participant is a classical instrumentalist

Exclusion Criteria:

* Other severe mental conditions than MPA (e.g. schizophrenia, severe depressive episode, addiction)
* Acute suicidality
* Epilepsy or other disorders of the central nervous system (e.g. tumor, encephalitis)
* Contraindications to aerobe exercise Training
* Start or modification of an anxiolytic pharmacotherapy or other therapy within the last four weeks
* Current psychotherapy
* no sufficient capability to consent to trial
Aspirin Versus Aspirin + ClopidogRel Following Transcatheter Aortic Valve Implantation: the ARTE Trial

The purpose of this study is to compare aspirin + clopidogrel with aspirin alone as antithrombotic treatment following transcatheter aortic valve implantation (TAVI) for the prevention of major ischemic events \[myocardial infarction (MI), ischemic stroke\] or death without increasing the risk of major bleeding events.

Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to standard aortic valve replacement for the treatment of patients considered to be at very high or prohibitive surgical risk. Nowadays the procedure is associated with a very high success rate (\> 95%) but major peri-procedural ischemic complications such as myocardial infarction (MI) or ischemic stroke occur in about 2% (0% to 17%) and 3% (2% to 7%) of the cases, respectively. The recently published PARTNER trial showed a stroke rate as high as 6.5% within the 30 days following TAVI, with most (77%) of these events diagnosed as major strokes. In order to avoid such ischemic complications full dose anticoagulation (usually intravenous heparin) is administered during the TAVI procedure, whereas aspirin (long-term) + clopidogrel (1 to 6 months) have been the recommended antithrombotic treatment following the procedure. However, this antithrombotic regime has been recommended on an empirical basis, and no studies have as yet shown the efficacy of aspirin + clopidogrel versus aspirin alone or no antithrombotic treatment in preventing ischemic events following TAVI procedures. Also, patients undergoing TAVI nowadays are usually octogenarians and very frequently exhibit comorbidities such as hypertension, abnormal renal function or prior cerebrovascular disease, which significantly increase the risk of major bleeding. Indeed, TAVI procedures can also be associated with major vascular complications which in turn can complicate with life-threatening or major bleeding. It is well know that clopidogrel on top of aspirin is associated with a higher rate of major bleeding complications, especially in elderly patients. It would therefore be of major clinical relevance to determine the risk/benefit ratio of using a dual antithrombotic therapy following TAVI procedures in order to recommend the most appropriate antithrombotic treatment in this high-risk population. The ARTE trial is a multicenter Canadian pilot trial to evaluate the efficacy and safety of aspirin versus aspirin + clopidogrel as antithrombotic treatment after TAVI.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a TAVI procedure with the Edwards SAPIEN XT valve (transfemoral or transapical)

Exclusion Criteria:

* Need for chronic anticoagulation treatment
* Major bleeding within the 3 months prior to the TAVI procedure
* Prior intracranial bleeding
* Drug-eluting stent implantation within the year prior to the TAVI procedure
* Allergy to clopidogrel and/or aspirin
Clinical Application of a Self Stabilizing Atlantoaxial Fusion Cage

Conventional open surgery often requires extensive dissection of the muscle insertion points of the suboccipital muscle group during the insertion position and direction of the atlas axis screw, resulting in sustained postoperative occipital neck pain and movement dysfunction. In order to overcome the shortcomings of the prior art mentioned above, the present invention provides a self stabilizing fusion cage with a wing plate. During surgery, a thinner and smaller screw through the wing plate is used to achieve a secure connection between the atlas axis and the fusion cage. Due to the smaller screw size, the screw placement has higher safety. The purpose of this study is to compare the advantages of using this new fusion cage compared to traditional surgical instruments.


Eligibility Criteria:
Inclusion Criteria:

1. Atlantoaxial dislocation
2. Agree to use a new self stabilizing atlantoaxial fusion cage for surgery where feasible
3. Sign an informed consent form;

Exclusion Criteria:

1. Atlantoaxial dislocation without surgical treatment
2. Patients who refuse to participate in this project