cyrilzakka/clinical-trials huggingface dataset:
Evaluation of MT-12 Implant Survival and Marginal Bone Loss

The trial is designed as a consecutive enrollment prospective one-center study. A minimum of 30 patients will be included in the study. At implant installation, the patient will be randomized to receive one of the two types of implants (Control: internal hexagon connection implants (CON.INT); Test: Morse taper connection implants (MT-12)). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be collected at -21 (second-stage surgery), -14 (impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the impressions are taken.


Eligibility Criteria:
Inclusion Criteria:

* Patient \>18 and ≤75 years old
* One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal)

Exclusion Criteria:

* One-stage bone augmentation
* Uncontrolled type 1 or 2 diabetes (HgA1c\>8)
* Known auto-immune or inflammatory disease
* Severe hematologic disorders, such as hemophilia or leukemia
* Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology)
* Liver or kidney dysfunction/failure
* Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy
* Long-term history of oral bisphosphonates use (i.e., 10 years or more)
* History of intravenous bisphosphonates
* Long-term (\>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system 3 months before inclusion
* Severe osseous diseases (e.g., Paget disease of bone)
* Pregnant women or nursing mothers
* Not able or not willing to follow instructions related to the study procedures
Single-port LC Might be Preferable for Managing Ovarian Dermoid Cyst.

Minimally invasive surgery has become the standard treatment for many gynecologic disease processes. In the last decade, numerous studies have demonstrated that laparoscopic approaches to various gynecologic oncology conditions-particularly for early-stage endometrial and cervical cancers as well as select pelvic masses-is feasible and results in shorter hospital stays, improved quality of life and comparable surgical and oncologic outcomes to abdominal staging.For instance, the typical gynecologic robotic surgical procedure will require Two to three 5-mm ports and one 12-mm laparoscopic ports. Recently, an even less invasive alternative to conventional laparoscopy surgery has been developed: laparoendoscopic single-site surgery (LESS), also known as single-port surgery. Single port laparoscopy is an attempt to further enhance the cosmetic benefits of minimally invasive surgery while minimizing the potential morbidity associated with multiple incisions. Preliminary advances in LESS as applied to urologic and gastrointestinal surgery demonstrate that the techniques are feasible provided that both optimal surgical technical expertise with advanced skills and optimal instrumentation are available. Recently, several publication showed the single port laparoscopic surgery is feasibility in gynecologic surgery including oophorectomy, cystecomty, and myomecomty. To our knowledge, the sample size of recent publication about single port surgery including cystectomy and myomecomty is small. Furthermore, these studies lack the comparison of single port and convectional laparoscopic surgery. Base on our recent study demonstrated that either the single-port or the conventional approach can be used for LAVH, but the single-port LAVH technique yielded less postoperative pain (Chen et al., Obestet Gynecol, 2011). The purpose of this study was to assess the feasibility of single port laparoscopic surgery in the treatment of benign gynecologic disease.

This study was designed as a retrospective case-control study, and port placement was one of the differences in operative procedures between the two groups. Patients with ovarian dermoid cysts were evaluated at Taipei Veterans General Hospital from June 13, 2011 through June 12, 2013. Approval for the study was obtained from the hospital's ethics committee, and informed consent was obtained from all patients (VGHIRB 2011-06-004IA).

Eligibility Criteria:
Inclusion Criteria:

* the patient received cystectomy for ovarian dermoid cysts (even while pregnant), the cyst received an American Society of Anesthesiologists physical status classification of I or II, and the patient provided signed informed consent.

Exclusion Criteria:

* patients who received an oophorectomy for dermoid cyst or had a dermoid ovarian cyst with malignant potential and concomitant surgeries for uterine lesion, pelvic organ prolapse or urodynamic urinary incontinence were excluded.
3D Ultrasound for the Imaging of Lymph Nodes in Patients with Breast Cancer

This early phase I studies how well a new 3D ultrasound (3D-US) imaging technology works in evaluating lymph nodes in patients with breast cancer. Ultrasound uses high-frequency sound waves to generate images of the body.

PRIMARY OBJECTIVES:

I. Conducting a pilot study to optimize the in vivo performance of the newly developed three-dimensional (3D)-ultrasound (US) technology.

II. Evaluate the performance of the new 3D-US technique in differentiating benign from malignant lymph nodes in patients.

III. Compare the performance of the new 3D-US method with conventional two-dimensional (2D)-US for localizing the clipped lymph nodes.

OUTLINE:

Patients undergo 3D-US on study. Patients who have a lymph node clip placed and undergoing neoadjuvant chemotherapy undergo imaging of the clipped node before surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with lymph node biopsy or lymph node clip placement as per routine clinical care.
* Age of 18 or older.

Exclusion Criteria:

* Vulnerable subjects such as prisoners and adults lacking capacity to consent.
Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia

Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cervical dystonia

Exclusion Criteria:

* Current or previous botulinum toxin treatment of any type for any condition
Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular

The aim of this study is to evaluate whether the use of Sugammadex for reversing the neuromuscular blocking effects of rocuronium during neurointerventional procedures can speed recovery of neuromuscular function. Half of participates will receive Neostigmine with glycopyrrolate, while the other half will receive Sugammadex.

Incomplete recovery from neuromuscular blocking agents (NMBAs) residual block after anesthesia and surgery continues to be a common problem in the postanesthesia care (PACU).

Neostigmine remains the most common acetylcholinesterase inhibitor in the United States. However, administration of the drug significantly impairs genioglossus muscle activity when administered after full recovery from neuromuscular block. Moreover, doses of neostigmine exceeding 0.06 mg/kg increase the risk of respiratory complications independent of NMBAs effects.

Sugammadex is a modified γ-cyclodextrin that rapidly reverses that effect of the steroidal nondepolarizing NMBAs rocuronium and vecuronium. Sugammadex forms a stable, inactive 1:1 complex with rocuronium or vecuronium, reducing the amount of free NMBA available to bind to nicotinic acetylcholine receptors at the neuromuscular junction. Unlike neostigmine, sugammadex completely reverses even dense neuromuscular blocks.

Patients having catheter-based neurointerventional procedures are kept deeply anesthetized. It is common to find patients nearly completely paralyzed at the end of neurointerventional procedures and have a markedly delayed emergence while waiting for muscle function to recover sufficiently to safely antagonize with neostigmine.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* American Society of Anesthesiologists (ASA) physical status 1-3;
* Scheduled for catheter-based neurointerventional procedures including coiling and stent insertion;
* General anesthesia.

Exclusion Criteria:

* Suspected difficult intubation;
* Neuromuscular disorder;
* Renal impairment creatinine ≥ 2 mg /dl;
* Hepatic dysfunction;
* History of malignant hyperthermia;
* Allergy to neuromuscular blocking drugs, Sugammadex, neostigmine or glycopyrrolate;
* Perioperative respiratory infections and/or pneumonia;
* Intubated or unresponsive;
* Pregnancy or breastfeeding.
Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of IAN Block of Teeth With Irreversible Pulpitis

Buffering of local anesthetics (alkalinization) has been suggested in achieving pain control. The purpose of this prospective, randomized, double-blind study was to evaluate the effect of adding 0.6 mL 8.4% sodium bicarbonate to 3.0 mL 2% lidocaine with 1: 80,000 epinephrine on the success rate of IAN block for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.

Some studies have been shown buffering of local anesthetics reduce pain of injection, hasten the onset of anesthesia, and improved success rate of anesthesia. Others reported buffering of local anesthetics cannot reduce pain of injection, hasten the onset of anesthesia, and improve success rate of anesthesia. There are no studies evaluating a sodium bicarbonate-buffered lidocaine formulation for IAN block for teeth with irreversible pulpitis.

Eligibility Criteria:
Inclusion Criteria:

* vital mandibular molar tooth
* diagnosis of symptomatic irreversible pulpitis

Exclusion Criteria:

* younger than 18 years old
* history of significant medical conditions
* allergies to local anesthetics or sulfites
* pregnancy
* taking any medications that might influence anesthetic assessment
* active sites of pathosis in area of injection
* inability to give informed consent
Comparative Study of Analgesic Effect of Ultrasound Guided PENG Block vs FEMORAL BLOCK in Hip Fracture

To study the analgesic effect of ultrasound guided PENG Block vs Femoral nerve block in patients with Hip fracture presenting to Emergency department

comparative study of analgesic effect of ultrasound guided PENG block vs femoral nerve block in patients presenting to emergency department

Eligibility Criteria:
Inclusion Criteria:

* Adults more than or equal to 18 yrs with Hip fracture
* patients who consent for procedure

Exclusion Criteria:

* history of allergy to local anaesthetics
* pregnant or lactating women
* infection or burns at injection site
* patients with polytrauma
* patients with hemodynamic instability
* patients with low GCS
* patients on anticoagulant or hematological disorders
* injuries with neurovascular compromise on affected limb
* patients with distorted anatomy
Early Prevention of Post Traumatic Stress Disorder

Sunnybrook Health Sciences Centre is Canada's largest trauma centre, treating 1,100 patients annually. A traumatic experience can lead to post-traumatic stress disorder, which increases hospital stays, emergency visits and disability. Despite developing leadership to manage a "Code Orange" mass trauma, Sunnybrook lacks guidelines in the psychological management of patients who have experienced trauma. The department of psychiatry currently holds a Traumatic Brain Injury clinic and PTSD services for youth but lacks both immediate intervention, prevention and adult services. This research will enable us to gain best evidence expertise to develop guidelines as well as a sustainable PTSD treatment program, with clear outcomes to assess effectiveness, psychiatric morbidity, use of healthcare, disability and substance abuse.

The five world-expert-consensus intervention resilience based principles will be operationalized in guidelines for the management of trauma patients, their caregivers and in routine nursing and trauma team care from the Emergency to the ward, and discharge, through to outpatient care. It is hypothesized that this will improve the psychological recovery of patients at risk of developing PTSD after a traumatic injury. In addition, early screening and intervention for increased risk of PTSD will be implemented one month after the trauma. It is hypothesized that such trauma informed psychological management, early screening and expert treatment using prolonged exposure will reduce hospital stays, functional disability, as well as longer-term psychiatric morbidity, including substance abuse.

The study is a longitudinal interventional study, with a control group who have treatment for their trauma with no guidelines for psychological management, staff training, patient and family intervention/education. In the intervention group, who will have all of the above, participants will be stratified according to risk factors for PTSD and randomized 1:1 in "low risk" and "at risk" groups-those who will have a prolonged exposure intervention and those who will not.

Eligibility Criteria:
Inclusion Criteria:

* undergone severe physical trauma within the last 3 days
* An abbreviated Injury Severity score of 1-3

Exclusion Criteria:

* 14 years of age or younger
* an inability to communicate sufficiently in English
* A diagnosis of psychosis, mental retardation and/or autism
Orofacial Difficulties in Rooming-in

The purpose of this study is to identify the orofacial difficulties during the maternal breastfeeding in rooming-in.

Cross-sectional and quantitative study with sample consisted of 28 dyad present in rooming-in of the Assis Chateaubriand School Motherhood during August and December of 2009.

Eligibility Criteria:
Inclusion Criteria:

* mothers of the newborns participating in the study, regardless of the gender, ethnic and/or age.

Exclusion Criteria:

* newborns who presented oropharyngelarynx structural abnormality, impossibility to feed by mouth and/or exposed in bilispot.
Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms - the Biology and Outcome (BiO)-Project

This is a registry study in adult patients with newly diagnosed or refractory/relapsed myeloid neoplasms

Investigator's sites: 80-90 sites in Germany and Austria

Estimated duration of observation of an individual patient:

10 years maximum

Objectives

* To register all patients with AML and related neoplasms, newly diagnosed or relapsed/refractory in all AMLSG participating centers (completeness)
* To perform rapid analyses of disease-related genetic markers (incidences, treatment recommendations)
* To assess patient and family history, as well as patient characteristics
* To evaluate treatment response (CR, CRh, CRi) and outcome data (event-free survival \[EFS\], relapse-free survival \[RFS\], cumulative incidence of relapse \[CIR\], cumulative incidence of death \[CID\], overall survival \[OS\])
* To evaluate the impact of measurable residual disease (MRD) by different methods
* To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)
* To store biosamples from all patients (e.g., bone marrow, blood, plasma, normal tissue; e.g., skin biopsy, finger nails, hairs, sputum, or urine)


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected diagnosis of acute myeloid leukemia and related neoplasms, newly diagnosed or relapsed/refractory, classified according to the International Consensus Classification
* Age ≥ 18 years. There is no upper age limit.
* Signed written informed consent

Exclusion Criteria:

* Severe neurological or psychiatric disorder interfering with ability to give an informed consent
* No consent for registration, storage and processing of the individual patient and disease characteristics and course as well as information of the family physician about study participation
* No consent for biobanking of patient's biological specimens and performance of analyses on stored material.
Ultrasound-guided Intermediate Cervical Block Versus Superficial Cervical Block for Carotid Endarterectomy (CERVECHO)

The aim of this prospective, randomised, controlled study is to compare the efficacy of ultrasound-guided intermediate cervical block to superficial block for carotid endarterectomy.

Patients scheduled for carotide endarterectomy under regional anaesthesia (ropivacaine 4.75 mg/ml) are randomised into 2 groups according to the technique of anaesthesia performed: superficial cervical block (Control group) or, ultrasound guided intermediate cervical block (Echo group). Main outcome is cervical block success, defined by surgery performed under regional anaesthesia without supplemental topical lidocaine. Secondary outcomes are rate of conversion to general anaesthesia, total dose of supplemental topical lidocaine and block-related complications.


Eligibility Criteria:
Inclusion Criteria:

* patient scheduled for elective carotid artery endarterectomy under regional anaesthesia

Exclusion Criteria:

* indication for general anaesthesia
* known bleedind diathesis
* past medical allergy to local anaesthesic
* severe chronic pulmonary disease
* contralateral diaphragmatic motion abnormalities
* previous cervical ipsilateral surgery
* age \< 18 years
Effects of Two Different Applications in Fibromyalgia

The study aims to determine the effect of connective tissue massage and taping applications on the pain and depression complaints of fibromyalgia patients and to compare their impact on quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with fibromyalgia.
* Be in the age range of 20 - 55 years.
* To be a volunteer participant in the research.
* Being able to communicate comfortably.
* To be able to act independently.

Exclusion Criteria:

* Having had a surgical operation within the last year.
* Presence of significant infection.
* Being diagnosed with cancer.
* Being pregnant or breastfeeding.
* Being addicted to drugs or alcohol.
* Having a cognitive problem.
Group CBT for Intolerance of Uncertainty

Generalized anxiety disorder (GAD) is a debilitating condition involving excessive and uncontrollable worry and anxiety. Difficulty tolerating the uncertainties of life, known as intolerance of uncertainty (IU), has been shown to be key in the development and maintenance of GAD symptoms. A new, streamlined cognitive-behavioural treatment that targets IU has been shown to be effective in at reducing GAD symptoms, IU, and general psychopathology when delivered one-on-one with a therapist, as shown in a recently published pilot study. The individual format of this treatment is now being evaluated in a randomized controlled trial (RCT). The overall objective of this study is to pilot test a group version of the treatment protocol to determine if a future RCT of this group treatment is both warranted and feasible. We will also conduct a preliminary investigation into the group treatment's efficacy. A total of two pilot groups (N = 12-20) will be conducted with participants recruited from two clinical hospital sites in Winnipeg, Manitoba, Canada. The group treatment protocol will be delivered over the course of 12 weekly therapy sessions. Participants will complete assessment measures at pretreatment, posttreatment, and at a 3-month follow-up point. All assessments and treatment sessions will be conducted virtually via videoconferencing platform due to ongoing COVID-19 pandemic restrictions.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of generalized anxiety disorder (GAD)
* High Intolerance of uncertainty (IU)

Exclusion Criteria:

* Comorbid psychosis, organic brain disorder, bipolar disorder, or current substance use disorder
* Receiving concurrent psychological treatments or other counselling
* Psychotropic medications must remain stable during the study period and for 3 months prior to intervention
Supported Employment in a Swedish Context

This project aims at generating evidence of a work-rehabilitation strategy that benefits the people with severe mental illness (SMI) who want to work, increase their sense of well-being and integration in society, decrease their financial dependence and experiences of stigma and discrimination. The project is likely to help form the basis of how to implement the evidence based supported employment (SE)-model, Individual Placement and Support model (IPS), in a Swedish work-rehabilitation context. In the long run, evidence of SE in a Swedish context could help to decrease the period of sick-leave and increase fulfilling and productive lifestyles among people with severe mental illness. In all, the effectiveness of SE can improve the quality of life for the target group, the quality in mental health care rehabilitation and decrease the costs of treatment and care.

Evidence-based mental health treatment and scientific support has gained increased attention in Sweden. The Swedish National Board of Health and Welfare emphasizes the importance of Supported Employment. Especially since there are no study in Sweden that has an RCT-design, and that fully take on the responsibility of implementing a SE- intervention in concordance with the evidence based version of SE in mental health care, the Individual Placement and Support model, IPS. Internationally, SE according to IPS is an evidence-based approach to help people with SMI find and keep employment. RCT and quasi-experimental studies showed that IPS (Place-Then-Train), is more effective than the traditional stepwise vocational rehabilitation model(Train-Then-Place. However, there is no research evidence if the SE/IPS will function in relation to a Swedish benefit and health system and work-rehabilitation context. This intervention project will therefore not only study the effects of vocational and health-related outcomes and experiences, but also study the implementation of SE/IPS, its feasibility and level of fidelity in a Swedish context.

Eligibility Criteria:
Inclusion Criteria:

* People with Severe mental illness, which mostly means having a diagnosis of psychosis
* Communicate in Swedish
* Express interest in working in the near future
* Have professional care or support from psychiatric clinic
* Attend to a SE-introductory meeting

Exclusion Criteria:

* Additional organic or physical disability to having psychosis