cyrilzakka/clinical-trials huggingface dataset:
Stability, Marginal Bone Loss and Occlusal Load Analysis of PEEK Abutment Supported on Short Implant

this study will be directed toward evaluating stability, marginal bone loss and occlusal load of posterior customized PEEK abutments on Ti-bases supported by short implant

although short implant solved many clinical problems; it is sometimes associated with loss of osseointegration which is firstly expressed by peri-implantitis and marginal bone loss. Also, PEEK is a very promising material characterized by low modulus of elasticity thus it can act as a shock absorber. Whether constructing superstructure components of short implant from PEEK will improve their performance or not is lacking in the dental literature.

To conduct the present study, the following will be used:

1. Customized screw retained PEEK abutment/crown on a Ti base.
2. Prefabricated titanium abutment.
3. Short implant. The study will be conducted on 12 patients with missing single posterior tooth indicated for short implants) near anatomical structure or atrophic ridge), attending the outpatient clinic of the Crowns and Bridges department, Faculty of Dental Medicine for Girls, Al-Azhar University.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age range of patients 30-45 years old, with no gender prediction, able to read and sign the informed consent. 2. Patient with missing posterior tooth indicated for replacement with short implant as there are any anatomical limitation (near maxillary sinus or inferior alveolar nerve) or atrophic ridge. 3. Opposing natural teeth should be present. 4. The edentulous ridge should be free from any infection or remining root. 5. Patient should be able to tolerate surgical procedure of implant procedures physically and psychologically. 6. Patient should be willing to return for follow-up examination and evaluation.

Exclusion Criteria:

* 1. Patients with active periodontal diseases. 2. Patient with poor oral hygiene and motivation. 3. Pregnant women. 4. Patient with unrealistic expectations. 5. Patients with parafunctional habits and smoker. 6. Patient with systemic disease and immunocompromised patients which will prevent surgical procedure. 7. Recent extraction or extraction socket with infection or remining root.
Laser Therapy for Pediatric Burn Scars

A new era of outcomes for pediatric burn patients has begun as burn care continues to improve. Unfortunately, complete restoration of burn-injured skin may be limited by the development of hypertrophic scarring. Treatment with laser therapy is one of the newest forms of scar therapy available. Although laser therapy has only been adopted by burn clinicians within the last several years, early evidence suggests that it may offer significant benefits. Thus the aim of this study is to investigate the effectiveness of using laser therapy to treat hypertrophic burn scars in pediatric patients by using a comprehensive set of subjective and objective scar assessment tools.


Eligibility Criteria:
Inclusion Criteria:

1. Age 1-18 years at presentation
2. Patients with a hypertrophic burn scar that has been clinically diagnosed by a burn care specialist
3. Hypertrophic burn scar resulting from any etiology
4. Hypertrophic burn scar is ≥ 2 months post healing
5. Ability to complete English- language questionnaires

Exclusion Criteria:

1. Patients with concomitant skin disease (i.e. chronic skin conditions, herpes infection)
2. Patients with a history of keloid scarring
3. Patients who cannot tolerate the intravenous (IV) sedation used to perform laser therapy procedures
4. Patients who have had previous laser therapy procedures
Evaluation of Many Men, Many Voices, An STD/HIV Prevention Intervention for Black MSM

The purpose of this program evaluation is to determine whether the "Many Men, Many Voices" HIV/STD prevention intervention is effective in reducing HIV sex risk behaviors and increasing HIV testing among African-American men who have sex with men (MSM), who may or may not self-identify as gay. The intent of this program is to support the evaluation of an existing intervention and provide feedback to the implementing organization for improved program effectiveness, not to conduct research.

Black men who have sex with men (MSM) in the United States experience disproportionately high rates of HIV and other sexually transmitted infections (STIs); however, the number of evidence-based interventions for Black MSM is limited. This study evaluated the efficacy of Many Men, Many Voices (3MV), a small-group HIV/STI prevention intervention developed by Black MSM-serving community-based organizations and a university-based HIV/STI prevention and training program. The study sample included 338 Black MSM of HIV-negative or unknown HIV serostatus residing in New York city. Participants were randomly assigned to the 3MV intervention condition (n = 164) or wait-list comparison condition (n = 174). Relative to comparison participants, 3MV participants reported significantly greater reductions in any unprotected anal intercourse with casual male partners; a trend for consistent condom use during receptive anal intercourse with casual male partners; and significantly greater reductions in the number of male sex partners and greater increases in HIV testing. This study is the first randomized trial to demonstrate the efficacy of an HIV/STI prevention intervention for Black MSM.

Eligibility Criteria:
Inclusion Criteria:

* Black men who have sex with other men (i.e., self-identify as gay or bisexual or same gender-loving, or sexually active with other men and do not identify as gay or bisexual, or have sexual or emotional attraction to other men)
* 18 years of age or older
* Self-report their HIV serostatus as negative or unknown
* Willing to attend an intervention retreat (without their primary partner)
* Willing to discuss male-to-male sex
* Resident of the New York Metropolitan area and plan to reside in that area for at least 6 months
* Not previously participated in a Many Men, Many Voices intervention program

Exclusion Criteria:

* Individuals indicating an HIV positive serostatus
* Under 17 years of age
* Individuals not meeting the inclusion criteria specified above
Intra-Articular, Single-shot Injection of Hyaluronic Acid and Corticosteroids in Knee Osteoarthritis

The aim of present study is to to investigate whether the combined injection of HA and CS was superior than HA alone in the treatment of knee OA.

Intra-articular injection of hyaluronic acid (HA) or corticosteroids (CS) has been widely used with debate on its efficacy in osteoarthritis (OA). The aim of present study is to to investigate whether the combined injection of HA and CS is superior than HA alone in the treatment of knee OA.

Eligibility Criteria:
Inclusion Criteria:

According to radiographic findings, patients who are suffering from knee OA for over 3 months have to be stage II-IV according to the Kellgren-Lawrence (KL) grade by a senior radiologist. The diagnosis of symptomatic knee OA is based on American Rheumatism Association classification criteria for knee osteoarthritis.

Exclusion Criteria:

Exclusion criteria are the diagnosis of rheumatoid arthritis or other inflammatory OA, presence of trauma or pain-causing diseases, treatment with oral medications in recent 3 days, physiotherapy and intra-articular injection of HA or CS in the past 6 months. Participants who are allergic to any of the medications used in this study or diagnosed with current systemic infection are also excluded.
Effect of Verbal Positive Reinforcement, Contingent Escape and Rewarding on Behaviour of Children Undergoing Primary Molar Pulpotomy: a Randomized Clinical Study

The purpose of this study to evaluate the effect of verbal positive reinforcement, contingent escape and rewarding on behaviour of children undergoing primary molar pulpotomy.

this study evaluated Effect of Verbal Positive Reinforcement, Contingent Escape and Rewarding on Behaviour of Children Undergoing Primary Molar Pulpotomy

Eligibility Criteria:
Inclusion Criteria:

1. Children aged between 4 to 6 years of both sexes.
2. Children with behavior rating score 2,3 or 4 of Frankl 's behavior rating scale.
3. Children with carious lesions indicated for pulpotomy.
4. Restorable primary molars.

Exclusion Criteria:

1. Children with special health care needs.
2. Children suffering from systemic diseases.
3. Unrestorable tooth.
4. Extremely uncooperative children.
Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions

This study compared the clinical outcomes of coronally advanced flap using two different surgical strategies in the treatment of multiple gingival recessions.

The objective of this split-mouth, randomized controlled trial was to compare the clinical outcomes of coronally advanced flap (CAF) using two different surgical strategies in the treatment of multiple gingival recessions. Recessions were randomly treated according to a split-mouth design by means of: CAF with oblique interdental incisions (OBL technique) or CAF with horizontal interdental incisions (HOR technique). Marginal gingival recession (REC), clinical attachment level (CAL), pocket probing depth (PPD), height of keratinized tissue (HKT) and thickness of keratinized tissue (TKT) were measured at baseline, 3 and 6 months after treatment. Patient-centered outcomes concerning morbidity and improvement in the esthetic appearance were recorded using a Visual Analogue Scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy subjects
* Patients should have bilateral Class I and II MGRs (Miller 1985) in maxillary tooth (at least three recession-type defects affecting adjacent teeth in each side of the maxilla).
* At least 20 teeth and no sites with attachment loss and probing pocket depth (PPD) \> 3 mm.
* Full-mouth plaque and bleeding on probing of \< 20%.
* Involved tooth should present tooth vitality, absence of caries, restorations or extensive non-carious cervical lesion.

Exclusion Criteria:

* History of smoking.
* Antimicrobial and anti-inflammatory therapies in the previous 2 months.
* Previous mucogingival surgery at the region to be treated
* Systemic conditions that could affect tissue healing (e.g. diabetes).
* Use of orthodontic appliances.
Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of PGE2

Before, during and after intravenous administration of PGE2 we score/measure headache, rCBF, blood flow in the middle cerebral artery and diameter of superficial temporal artery and correlate that to known pathophysiology of headache to see if PGE2 is involved in headache pathophysiology.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Primary Headache, headache on the day of the investigation, hypertension, hypotension, pregnant/nursing, daily intake of medication (except oral contraceptives), Cardiovascular or CNS disease, drug/alcohol abuse, psychiatric disease
Evaluation of Long-term Efficacy of Treatment With Lamazym

The overall objective is to evaluate the long-term efficacy of Lamazym i.v. treatment in patients with alpha-Mannosidosis previously enrolled in Lamazym trials and currently receiving the treatment according to the AfterCare Program.

The primary objective of the trial is to evaluate the impact of the long-term treatment with Lamazym upon the level of biomarker oligosaccharides in serum and upon the endurance as measured by the change from baseline in the number of steps climbed in 3 minutes (3MSCT).

As secondary objectives, the long term efficacy of Lamazym will be investigated upon endurance as measured by the change from baseline in the number of meters walked in six minutes (6MWT), upon pulmonary function, motor proficiency by BOT-2 and hearing capability by audiometry. In addition, cognitive development will be assessed by Leiter-R test. CNS involvement will be evaluated with MRI/MRS (for patients who previously participated in rhLAMAN-02 trial), CSF biomarkers (Tau, NFL, GFAp) and CSF biomarkers oligosaccharides. Clearance of oligosaccharides in urine will be measured.

Long-term safety and Pharmaco-Kinetic (PK) profile after long-term treatment as measured by rhLAMAN levels in plasma will be assessed as well.

Quality of life will be assessed by questionnaires (CHAQ and EQ-5D-5L).

Eligibility Criteria:
Inclusion Criteria:

1. The subject must have participated in the phase 1 trial (EudraCT number: 2010-022084-36), phase 2a trial (EudraCT number: 2010-022085-26), phase 2b trial (EudraCT number: 2011-004355-40) or phase 3 trial (EudraCT number: 2012-000979-17)
2. The subject must still be receiving weekly intravenous infusions of Lamazym according to the AfterCare Program
3. The Subject or subjects legally authorized guardian(s) must provide signed, informed consent prior to performing any trial-related activities
4. The subject and his/her guardian(s) must have the ability to comply with the protocol

Exclusion Criteria:

1. History of bone marrow transplantation
2. Presence of known clinically significant cardiovascular, hepatic, pulmonary or renal disease or other medical conditions that, in the opinion of the Investigator, would preclude participation in the trial. Subjects unable to perform the motor tests independently from support are permitted to participate in the trial and will be evaluated for the remnant non motor endpoints
3. Any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the trial
4. Pregnant and/or lactating women cannot participate in the trial. Concerning women of child bearing potential (WOCBP), the investigators will decide whether or not there is a need for contraception. This assessment will be done through interviews with the patient and parents.
5. Participation in other interventional trials testing IMP, including rhLAMAN-07 (EudraCT number: 2013-000336-97) and rhLAMAN-09 (EudraCT number: 2013-000321-31) trials with Lamazym
6. Pause of the IMP for 2 consecutive weeks during the last month. Subjects are allowed to be re-screened
Gut Microbiota in Acute Stroke Patients

This study is to find out the significance of gut-microbiota in acute stroke patients, including their neurological, radiological outcomes as well as their stroke mechanisms.

Patients who suffered from acute stroke and in hospitalization in Prince of Wales Hospital will be recruited in the study.

After the informed consent, their first bowel opening will be collected for storage. They will also receive assessment by the stroke team at 3 and 6 months to determine their outcomes (NIHSS and mRS). Clinically and radiologically parameters including their degree of disability, imaging findings will also be collected to determine whether there are any correlations with the stool microbiota composition against matched individuals.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as acute ischaemic stroke
2. Aged 18 or above Chinese
3. Radiological evidence of acute ischaemic stroke by Computed tomography (CT) or magnetic resonance imaging (MRI) brain.

Exclusion Criteria:

1. Patient with symptoms and signs suggestive of alternative diagnoses,
2. Evidence of intracerebral haemorrhage,
3. Absence of DWI evidence of acute ischaemic infarct,
4. Pregnancy,
5. Evidence of gastrointestinal infection/ inflammation/ obstruction
6. History of partial or total resection of small or large bowel, as well as gut re-anastomosis,
7. Use of antibiotics within 2 weeks prior to symptoms onset,
8. Gastrointestinal malignancy
9. Any hospitalization within 3 months before recruitment
10. Institutionalized patients
Nurse Parental Support Using a Proactive Mobile App in Symptom Management for Children with Mechanical Ventilation

The aims of this study are to test the effectiveness of a nurse support using a proactive mobile app to enhance parental self-efficacy in symptom management for children using mechanical ventilations, and alongside identify factors facilitating or deterring the program implementation.

A single group pre-post quasi-experimental study on parents of CMC requiring mechanical ventilation.

Parents will be recruited from a non-government office, with an estimated sample size of 52 parents. Self-administrated questionnaire, and semi-structured interview guide will be used for data collection.

Parents of children required mechanical ventilations at risk of high stress levels because these children have multisystem diseases, including severe neurologic conditions, resulting in potential premature death. Literature suggested that increasing parental self-efficacy in managing their child's symptoms could improve the child's health.

Nurse parental support in symptom management using a proactive mobile health application is an alternative method considered more accessible and nurse-parent interactivity to continue home-based support for the CMC and parents.

Self-administrated questionnaire, and semi-structured interview guide will be used for data collection. Descriptive statistics, including proportions for categorical variables, mean, and SD for normally distributed continuous variables, and median and inter-quartile range for non-normally distributed variables, will be reported. Generalized estimating equation will be used to address the objectives with appropriate link function. Qualitative data will be analyzed using thematic analysis to identify the facilitator, and barriers of program implementation.

Eligibility Criteria:
The inclusion criteria for parents are:

1. parent of a child with mechanical ventilation aged 2-18
2. having a Smartphone
3. able to communicate in Chinese and read Chinese
4. living with his/her child at home.

The exclusion criteria for parents are:

1. a reported mental health disorder
2. engaging in other structured programs related to symptom management 3) living in an area with no internet coverage.
Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.

Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high. Placement of a mesh aims at reducing the recurrence rate, but mesh implants can cause complications.

This study is designed to determine the effectiveness of one type of mesh (tensionfree vaginal mesh; Prolift), compared with the standard prolapse surgery. A secondary objective is to track the complications of both procedures.

Patients with recurrent prolapse after surgery can participate in this study. A total of 194 women will be included. At random 97 patients undergo a standard prolapse operation and 97 patients undergo an operation with the mesh. Evaluation will take place during surgery, at the postoperative visit after six weeks, and after six months and twelve months. Quality of life, degree of vaginal prolapse, subjective effectiveness, safety and incidence of complications will be evaluated.

An amendment to the original study has been approved by the Ethical Committee to examine long term outcome of this RCT at 7 years. This study was completed in december 2015.

Eligibility Criteria:
Inclusion Criteria:

* recurrent anterior and/or posterior prolapse POP-Q stage 2 or more
* patient has agreed to undergo implantation of TVM (prolift) or fascial plication
* patient is willing to return for follow-up evaluation at 6 weeks, 6 months and 12 months
* patient is willing to complete quality of life questionnaires at 6 and 12 months

Exclusion Criteria:

* patient is or wants to become pregnant
* patient has had previous synthetic mesh procedure (a previous mid-urethral sling procedure is NOT an exclusion criterion)
* patient has current urinary tract or vaginal infections
* patient has a blood coagulation disorder
* patient has a compromised immune system or any other condition that would compromise healing
* patient has renal insufficiency and/or upper urinary tract obstruction
* patient is unwilling or unable to return for evaluation
* patient has had previous irradiation
* patient has any malignancy
* patient has large ovarian cysts of large myoma
Gated SPECT Abnormality With J Point Elevation

The investigators present an interesting co-incidence of Gated wall abnormality in the inferolateral wall in normal sestamibi myocardial perfusion images with J wave in the inferior derivations of the ECG in a patient. The subsequent coronary angiography demonstrated 80% mid right coronary artery (RCA) stenosis, which was intervened with a drug-eluting stent. The investigators conclude that even though the myocardial perfusion is normal, the association of gated wall abnormality with J wave presentation within the same location should be further evaluated.

The isolated J-point elevation considered as a type of "early repolarization" pattern (ER), is commonly been regarded as a benign finding. However, ER associations with arrhythmic sudden death from CAD or sudden cardiac death due to either idiopathic ventricular fibrillation have been shown. A recent study reported that ER especially in inferior leads, was related to worse cardiac outcomes in patients with CAD and they argue that ER in patients with CAD seems to be associated with the myocardial scar in the absence of pathologic Q waves.

Likewise, it is rare to detect clinically important gated SPECT abnormalities in normal myocardial perfusion studies with normal transient ischemic dilatation (TID) score and without any right ventricular uptake or any pulmonary uptake. Normal myocardial perfusion findings with wall motion abnormalities are frequently encountered in the interventricular septum of the patients who have previous bypass surgery or in patients with left bundle branch block (LBBB). However, the presented patient did not have the history of any intervention or LBBB. Perfusion and function discordance can be encountered in non-ischemic dilated cardiomyopathy patients; nonetheless, EF is markedly reduced in these patients.

The presented case, J point elevation in the ECG associated with relative wall motion abnormality was an important clue to determine CAD in the lack of evident perfusion defects or significant ECG findings.

The presence of wall motion abnormalities during stress study to predict CAD in patients with normal perfusion pattern, owing to balanced ischemia, was not only reported in multi-vessel disease but also in single-vessel disease without having presented the association between either regional wall motion abnormality or a localized particular ECG pattern and culprit lesion territory.

The interesting part of the presented case is, notwithstanding the myocardial perfusion pattern is normal, the abnormal gated finding with ECG changes having the concordant localization can be a significant milestone on the way to the diagnosis. To the best of investigators knowledge, the association between J point elevation and wall motion abnormality have not been described yet. Therefore, the investigators would like to draw attention to the importance of adjoining trivial ECG changes and wall motion abnormality for readers anymore.

Eligibility Criteria:
Inclusion Criteria:

* Case Report

Exclusion Criteria:

* None