cyrilzakka/clinical-trials huggingface dataset:
Effect of Abutment Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial

The aims of our study are to investigate in patients with immediate implantation replacing a single tooth in the maxillary anterior (#FDI 15-25) region the effect of (a) custom vs cylindrical stock healing abutments, then (b) screw retained single ceramic crowns, on the peri implant hard- and soft-tissue formation and blood flow.

AIMS:

In the maxilla, in the aesthetic zone, in patients with a thick phenotype, for a crown anchored with a solo immediate implant:

I.A To investigate hard and soft tissue volume changes around custom CAD/CAM (computer-aided design and manufacturing) vs. cylindrical zirconiom-dioxide (ZrO2) healing abutments 4 months after their fixation for immediate implant placement.

I.B To measure the thickness of keratinized mucosa by ultrasound I.C Monitoring microcirculation in wound healing by laser speckle contrast imaging (LSCI) and ultrasound.

II. Custom zirconia abutment (on Ti-base) retained, screw-retained all-ceramic solo restorations:

* Evaluation of hard and soft tissue volume changes
* Esthetic evaluation (Pink and White Aesthetic Scores (PES, WES)), FIPS (functional implant prosthodontic score), pain, follow-up of biological and technical complications at 1 and 3 years.

ARMS:

A. immediate implantation + cylindrical healing abutment + CAD/CAM screw-retained (on Ti-base), full-countour monolithic zirconium-dioxide restoration

B. immediate implantation + custom healing abutment + CAD/CAM screw-retained (on Ti-base), custom ZrO2 abutment retained all-ceramic restoration with hand-built-up supramucosal veneering

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years
* good general health
* good oral hygiene (FMPS \< 25%)
* healthy periodontium (PPD \< 4mm)
* thick phenotype
* maxilla anterior region (extended to 15-25 positions)
* solo missing teeth, intact adjacent teeth
* type 1 alveolar shape after extraction 1
* retained occlusion
* baseline buccal bone wall thickness at least 1.5 mm, based on intact CBCT scan
* patient voluntarily accepts and signs the information and consent form for the study

Exclusion Criteria:

* general ill health
* general surgical or oral surgery contraindication
* a patient who has undergone local radiotherapy
* active periodontal inflammation, inflammation of the alveolar cavity
* smoking
* posterior region
* pregnancy, lactation
* psychological or mental involvement affecting individual plaque control
* presence of an implant adjacent to the planned implant
* inadequate oral hygiene
* need for vertical bone augmentation
* gingival recession
* Inappropriate implant position for screw fixation
* bruxism
Evaluation of Posturing-Adherence in Patients After Intraocular Surgery

Measuring and logging head positions of patients which underwent surgery with gasendotamponades.

After surgery with gasendotamponades various positions are recommended to support the success of surgery. In patients with macular holes face-down-position is recommended. In patients with retinal detachment the recommended position depends on the region of the detachment.

The adherence of patients to follow this posturing instructions is very inhomogenous. Therefore the investigators want to measure the posturing by the use of a position-sensor. In some study arms the patients also receive a feedback from the sensor (tone, vibration) to correct the position.

The sensor-device was developed by the study-staff and is not commercial available. In addition there is no trade name. The patients safety of the used device was approved by the in house technical department.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* full thickness macular hole or retinal detachment
* informed consent

Exclusion Criteria:

* intraoperative complications with the need of other endotamponades
* combined treatment
Intersphincteric Approach to Perianal Fistula With High Risk for Postoperative Fecal Incontinence

.Rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence .

Lay open is the classic surgical management for Peri Anal fistula,however division of significant portion of anal sphincter may be divided with postoperative fecal incontinence,Many surgical techniques have been described for sphincter preservation ,But unfortunately associated high recurrence rate.Rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence .The operation is done in tow stages ,the first is to mobilize the transsphincteric part into the inter sphincteric plane thus converting it to intersphincteric fistula which is then laid open , with division of internal sphincter with preserving external sphincter.

Eligibility Criteria:
Inclusion Criteria:

* High arching transsphincteric fistula
* Transsphincteric fistula with high internal opening
* Transsphincteric fistula with short anal canal.
* Horseshoe perianal fistula fulfilling above criteria.

Exclusion Criteria:

* Transsphincteric fistula.
* Low perianal fistula.
Usefulness of Coronary Computed Tomography Angiography for Therapeutic Decision- Making; Revascularization

As the prospective, observational, cross-sectional study, the accuracy of CT angiography-based therapeutic decision-making for revascularization will be evaluated. The primary objective of this study is to evaluate the accuracy of CT angiography-based therapeutic decision-making for revascularization prior to conventional angiography whether CT angiography is an accurate non-invasive technique to determine the most appropriate therapeutic strategies.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 20 years old
* Patients who are scheduled for elective conventional coronary angiography and are undergone CT angiography prior to conventional coronary angiography.

Exclusion Criteria:

* Pregnant women or women with potential childbearing
Inflammation Reduction by TREhalose AdminisTration

Arterial wall inflammation has been consistently suggested to serve a causal role in promoting atherosclerosis and predisposing to hard cardiovascular outcomes. Therefore, there is a global trend in the pharmaceutical industry to develop safe and effective anti-inflammatory agents that could lessen arterial wall inflammation and prevent its detrimental impact on atheroma growth and instability. To this end, autophagy has emerged as a key regulator of inflammation and dysfunctional autophagy machinery has been consistently reported as a contributing factor to atherosclerosis and inflammation. Trehalose, a natural disaccharide sugar found extensively among miscellaneous organisms, by preventing protein denaturation plays various protective roles against stress conditions. Numerous studies indicated trehalose's ability to induce macrophage autophagy-lysosomal biogenesis and reduce inflammation. Also, intravenous (IV) administration of trehalose showed beneficial effects in the reversal of atherosclerosis in atherosclerotic animals. Therefore, in this study, the investigators will explore the potential efficacy of IV trehalose administration on arterial inflammation by employing an positron emission tomography (PET) with 18F-labeled fluoro-2-deoxyglucose (18F-FDG) and computed tomography (18F-FDG PET/CT) technique which noninvasively characterizes vascular inflammation and atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18-55 years
* Having a history of acute coronary syndrome
* Having a baseline high-sensitivity C-reactive protein (hs-CRP) of ≥ 2mg/L
* Willingness to participate in the trials.

Exclusion Criteria:

* Lactation or breastfeeding
* Diabetes mellitus
* Nephrotic syndrome or Estimated Glomerular Filtration Rate (eGFR) \< 30/mL/min/1.73m2
* Active or recurrent hepatic disease or/and alanine aminotransferase (ALT)/aspartate aminotransferase (AST) (ALT/AST) of \> 3 times upper normal limit or total bilirubin of \> 2 times upper normal limit
* Active infectious or febrile disease
* Any type of malignancy
* History of transplantation
* Consumption of immunosuppressive drugs.
Implementation of the ACP Guideline for Low Back Pain (IMPACt-LBP)

The purpose of this study is to assess whether the primary spine practitioner (PSP) model of care will lead to improvements in patient outcomes, as compared to usual care, based on change in patient-reported PROMIS Pain Interference and Physical Function from baseline to 3 months in patients aged 18 years and older with a primary complaint of low back pain (LBP).

This study is a pragmatic, multi-site, two-arm cluster-randomized trial with the unit of randomization at the primary care clinic level. The overall goal is to evaluate implementation of the American College of Physicians (ACP) guideline for LBP by assessing the comparative effectiveness of the PSP model, which involves first contact care for LBP patients from either a physical therapist (PT) or a doctor of chiropractic (DC), versus usual care, which involves first contact care with primary care physicians. The study includes patients aged 18 years and older with a chief complaint of LBP.

Co-primary endpoints to be assessed are changes in Patient- Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Physical Function from baseline to 3 months. The Investigators have chosen to use these co-primary endpoints as they represent two domains that are important factors related to patient improvement.

Secondary endpoints collected at baseline, 3, 6 and 12 months include Pain Catastrophizing Scale - 4-item short form, PROMIS Global-10 (v1.2), opioid use, imaging and diagnostic testing, provider visits, and LBP-associated procedures and treatments: surgical procedures, medication prescriptions, hospital admissions and emergency room visits.

Additional exploratory analyses among enrolled patients will assess whether the PSP model leads to 1) long-term improvement compared to usual care using the PROMIS Pain Interference and Physical Function at 6, 12, and 24 months; and 2) lower healthcare utilization and costs for LBP at 12 and 24 months.

Patients enrolled within the first 12 months of the data collection phase will be included in the 24-month exploratory analyses. Additional analyses will evaluate LBP-related utilization within the academic healthcare systems among all patients seen in intervention versus control primary care clinics utilizing de-identified clinic level data extracted from the EHR.

A total of approximately 1,800 patients who seek care at a participating primary care clinic with a complaint of LBP and meet study eligibility criteria will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18 years and older
2. initiating an outpatient visit for LBP at a participating PCP clinic
3. agree to participate and complete baseline questionnaire (in lieu of formal written documentation of consent)

Exclusion Criteria:

1. inability to provide consent or complete outcome questionnaires
2. positive screening for cauda equina symptoms (loss of total control of bowel/bladder associated with this episode of LBP )
Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department

The purpose of this study is to compare the safety and efficacy of Cardene I.V. to labetalol administered intravenously for the management of hypertension in the emergency department setting.

More than 3 million patients yearly receive an intravenous antihypertensive agent in the US. Despite this large number of critically ill patients treated annually, little research exists in the area of acute severe hypertension, specifically hypertensive emergency, a serious condition that contributes to morbidity and mortality.

Two agents that are commonly used to treat acute hypertensive crisis include labetalol and nicardipine. Cardene may provide benefits in titration and has shown to have lower dosage adjustments compared to labetalol. Nicardipine has also shown a decreased need for additional antihypertensives when compared to labetalol in patients with stroke in a neurological ICU.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Systolic blood pressure ≥180 mm Hg on 2 consecutive readings(10 minutes apart)presenting in the emergency department (ED)

Exclusion Criteria:

* Use of any investigational drug within 1 month prior to emergency department (ED)
* Pregnant or breast-feeding females
* Contraindications or allergy to beta-blockers and calcium channel blockers (see FDA approved labeling for nicardipine intravenous and labetalol)
* Subjects with decompensated congestive heart failure (CHF) or with a known left ventricular ejection fraction (LVEF) \<35%
* History of stroke within 30 days
* Known liver failure
* Suspected myocardial infarction
* Suspected aortic dissection
* Suspected cocaine overdose
* Concurrently receiving other intravenous (I.V.) hypertensive medications
Movement Control Exercises With and Without Specific Breathing Techniques for the Treatment of Chronic Low Back Pain

Chronic low back pain (CLBP) is a leading disability globally. Exercise therapies are one of the most commonly prescribed treatment options for CLBP. Specific breathing techniques have been shown to enhance brain-based pain modulation and autonomic nervous system balance; these changes have been shown to improve clinical effectiveness in terms of pain management and psychological factors compared to general exercise. However, no previous studies have added a specific breathing technique protocol to an evidence-based exercise program for CLBP.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-68-years-old
* Low back pain lasting more than 3 months (pain sensation more than 3 days per week)
* A numerical pain scale of more than 3
* ≥ 2/6 positive low back movement control tests (as described by Luomajoki et al.)
* Roland-Morris Disability Questionnaire score of five or greater
* Who are physically able to perform movement control tests and provide written informed consent.

Exclusion Criteria:

* Any history of malignant cancer
* Neurological disease affecting the central nervous system (MS, dementia)
* Rheumatic disease (fibromyalgia, ankylosing spondylitis/rheumatoid arthritis)
* Chronic obstructive pulmonary disease,
* Spinal surgery in the last 12 months
* A cardiac pacemaker
* Signs and symptoms of nerve root pathology during the clinic visits.
* Women who become pregnant during the data collection will also be excluded from the study.
Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse

This study seeks primarily to test, in a two-arm randomized controlled trial (RCT), the efficacy of Project IMPACT, an intervention that integrates Behavioral Activation (BA) with HIV risk reduction (RR) counseling for HIV-uninfected men who have sex with men (MSM) with stimulant use disorder at risk for HIV via sexual behavior. HIV-uninfected MSM with a diagnosis of stimulant use disorder will be equally randomized to one of two study arms: (1) the Project IMPACT intervention, BA-RR counseling, which lasts ten sessions; and (2) the standard of care (SOC) comparison condition, including two equivalent sexual risk-reduction counseling sessions. Participants will be followed for one year post-randomization, with assessments at months four, eight, and 12.

Project IMPACT targets both stimulant use and sexual risk reduction in effort to help individuals relearn how to enjoy safe but pleasurable activities. The intervention integrates BA, an evidence-based cognitive behavior therapy for improving mood and increasing activity, incorporated with RR counseling aimed to reduce risky sexual practices, and potential HIV acquisition. This RCT is a two-arm efficacy trial, comparing the Project IMPACT Intervention with a SOC arm. All participants will receive HIV testing, pre-/post-test risk reduction counseling, oral swab toxicology test at baseline and 12 months, assessment of interest/indication for Pre-Exposure Prophylaxis (PrEP) per Center for Disease Control guidelines, and active referral to local PrEP services as standard-of-care. Finally, the RCT will integrate resource utilization and cost-effectiveness analyses to examine cost efficiency of the Project IMPACT Intervention as a component of data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Assigned male at birth
* HIV-uninfected verified via rapid HIV test
* Self-reports in the past four months: CAS receptive or insertive with a cisgender male sexual partner, while using stimulants and without the protection of Pre-Exposure Prophylaxis (PrEP)\*
* Able to read, speak, and understand English
* Willing and able to provide informed consent

Exclusion Criteria:

* Does not live in the greater Boston or Miami areas, or will move away from Boston or Miami within the next 12 months
* Self-reports being 100% adherent to PrEP in the last four months
* Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
* Discovery of active suicidal ideation at the time of interview (participants will be referred immediately for treatment, but may join the study once resolved)-
* Involvement in any other HIV Prevention study that may interfere with the ability to test major study outcomes (e.g. another sexual risk reduction intervention or PrEP adherence intervention)
The Impact of Needle Manipulation and Accuracy Between Hand Held Automatic and Traditional Ultrasound Device

In this double blinded randomized controlled trial, the investigators would like to compare the effects on needle manipulation when relatively inexperienced sonographist (\< 1 year of ultrasound experience) perform ultrasound guided labor epidurals utilizing a traditional handheld ultrasound versus a handheld device that was engineered to provide automated guidance. The primary outcome of this study would be number of needle passes.

Patient will be approached upon admission to labor and delivery floor (Standard of care). The study will be presented to the patient and if they agree, they will be consented. (Study). Upon epidural patient request patient will be randomized to A-US vs B-US based on the randomization table. Ten envelopes will be available with the randomization choice. (Study). The resident will walk in with both US devices into the room (for patient blinding) and perform scan with the device the randomization table called for. (Study). After performing scan and markings of the patients back, the research fellow or clinical fellow will be called into the room to evaluate the number of needle manipulation and provide surveys related to patient and labor analgesia satisfaction. (Study).

Number of needle insertion attempts: defined as advancement of the needle through the skin in an effort to enter the epidural space; a needle requiring withdrawal from the skin for reinsertion is to be counted as an additional insertion attempt. Time to landmark identification: defined as the time interval between the start of needle puncture site identification and the time to first needle puncture attempt. The start time of needle puncture site identification in both the LT and UST corresponds to when the resident physician first places his/her hand on the patient to palpate the back. In both groups, all materials, supplies, and equipment will be prepared and readily available prior to the start of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* ASA-1, ASA-2, and ASA-3
* Patients with no known back deformities
* Ability to sit upright for epidural placement
* No prior lumbar surgery
* No allergies to ultrasound gel

Exclusion Criteria:

* Coagulopathy
* Low platelet count
* Allergies to local anesthetics
Open Thyroid Surgery With Pillow Versus no Pillow for Better Post-operative Outcomes

Primary: To compare the post-operative pain in patients with neck extension and without neck extension.

Secondary: To determine the benefit of neck exposure and peri-operative complications, which include duration of operation, intra-operative blood loss, recurrent nerve (RLN) injury and hypocalcaemia in both groups.

Hypothesis: Patients who undergoing thyroidectomy without neck extension will have less post-operative pain and there are no significant difference of post-operation complications between both groups.

Conventional open thyroid surgery is still one of the most common operations performed globally. Traditionally, patients who undergoing thyroid surgeries are usually positioned with extended neck by using pillow under shoulder in order to facilitate neck exposure and make the surgery easier. However, the degree of benefit from the extended neck is doubtful and there is little objective evidence that suggest extended neck thyroid surgery offers better outcomes. On the the hand, over-extension of the neck should be avoided because of it is associated with post-operative pain, vomiting, spinal damage and stroke. The objective of the present study is to compare the post-operative pain in patients with neck extension and without neck extension. In addition to that, we also like to determine the benefit of neck exposure and peri-operative complications, which include duration of operation, intra-operative blood loss, recurrent nerve (RLN) injury and hypocalcaemia in both groups. This is a prospective randomized controlled trial, which will be conducted from 1st of March 2012 till 30th September 2012. Given that approximately 300 to 400 patients would undergo thyroid surgery in each year, we estimated 180 patients will be recruited and randomly divided into 2 groups (neck extension and no neck extension) before undergoing open thyroid surgery for this trial. Visual analogue scale (VAS) is used to determine the post-operative pain. Primary end point and other peri-operative variables are then analyzed with SPSS software.

Eligibility Criteria:
Inclusion Criteria:

* All patients who will be undergoing thyroid surgery in Queen Mary Hospital and Tung Wah Hospital.
* Age from 18 till 80 years old.

Exclusion Criteria:

* Patients with history of bleeding disorder and tendency.
* Patients with history of cervical spine surgery and disease.
* Patients with history of RLN injury and underlying cause of hypocalcemia.
* Patient with mental disorder and subnormal intelligence.
* Pregnant and lactating women.
* Patients who is having other surgical problem that needed other surgical procedure performed at the same setting.