cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of Low-level Laser Therapy in Orthodontic Retention for Periodontal-compromised Patients

The aim of the study is to evaluate the effects of low-level laser therapy (LLLT) on patients with chronic periodontitis during a post-orthodontic period for 12 months. Following aspects will be assessed: 1. Effects on tooth stability maintenance and bone remodeling. 2. Effects on periodontal inflammation status. 3. Effects on cervical dentin sensitivity and quality of life. The study design is a randomised controlled trail. To eliminate any bias, the investigator will initially hypothesis there is no significant difference in the aforementioned aspects between teeth retained with an adjunctive LLLT strategy and those retained in a conventional regimen.

The study design is a randomised split-mouth design based on the result of investigator's pilot study. Thirty-five non-smoking Ethnic Chinese patients (male and female, age: 25-65 years) with chronic periodontitis will be recruited. The teeth in experimental group will receive LLLT during orthodontic retention period for 12 months, while the teeth in the control (placebo) group will not receive laser therapy. Orthodontic occlusal indices will be measured to explore LLLT's role in maintaining tooth stability. The effects of LLLT on periodontal inflammation status will be evaluated by assessing clinical periodontal parameters and the levels of supra-gingival and sub-gingival bacteria. The effects of LLLT on bone remodelling will be explored by testing the biochemical biomarkers in gingival crevicular fluid (GCF). Cone-beam computed tomography will also be used to provide clinical evidence of periodontal status and bone remodelling. Possible effects of LLLT on patient's quality of life will be investigated via validated questionnaires, subjective assessment of tooth sensitivity, and objective measurement of bite force.

Eligibility Criteria:
Inclusion Criteria:

Thirty-five non-smoking Ethnic Chinese patients (male or female; age: 25-65 years) will be recruited from the Prince Philip Dental Hospital, Faculty of Dentistry, the University of Hong Kong into the following selection criteria:

1. Systemically health (with special regard to disease affecting tissue repair);
2. No medications required for periodontal therapy and no use of any antibiotic and/or anti-inflammatory medication in the preceding month;
3. Chronic periodontitis with at least two pairs (clinically matched) displaced single-rooted teeth (each pair of teeth is in the same arch but in two contralateral hemi-arches respectively belonging to the same tooth typology) having at least one site probing depth of 5 mm or more, interproximal attachment loss of 3 mm or more, and radiographic signs of alveolar bone loss before periodontal and orthodontic treatment.
4. Recent completion of orthodontic treatment and readiness for debonding and retainer delivery.

Exclusion Criteria:

1. smoking;
2. pregnancy;
3. under orthodontic treatment.
Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement

Fluoroscopy is performed when placing a lead during a sacral neuromodulation procedure. During lead placement, subjects will receive either conventional or experimental fluoroscopic settings. The radiation exposure will be compared between the two groups.

Patients scheduled for lead implantation during sacral neuromodulation in the operating room and consent will be included in this study. Placement of the lead in the operating room with fluoroscopy is the standard of care in this procedure. Fluoroscopy is performed with a C-arm and there are settings that change the radiation exposure. Patients scheduled to undergo lead placement will be randomized to: a) the investigational (reduced radiation with fluoroscopic settings) or b. the control (conventional fluoroscopy).

The surgeon can change fluoroscopy radiation exposure by changing C-arm settings from the reduced radiation to conventional fluoroscopic options. During the surgery, the surgeon may change the settings from reduced radiation (intervention) to conventional fluoroscopy (control) to safely place lead. The surgeon will use their judgment to optimally place lead and maintain safety during placement. Any deviation from randomization will be recorded.

The intervention arm is defined: Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current.

The control arm is defined: The standard of care in the conventional fluoroscopy, the C-arm is set at 30 pulses-per-second and the current set at the default.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lead implantation for sacral neuromodulation that have overactive bladder as defined by urinary urgency, frequency, nocturia with or without urgency incontinence.

Exclusion Criteria:

* neurogenic bladder, BMI \>40, or peripheral neuropathy.
Washington State Community Expedited Partner Treatment (EPT) Trial

The Washington State Community Expedited Partner Therapy Trial is a stepped-wedge community level randomized trial designed to test the hypothesis that a public health program designed to increase the use of expedited partner therapy can decrease the prevalence of chlamydial infection in young women and the incidence of gonorrhea in Washington state. The study intervention will be modeled after and intervention previously evaluated in King County WA (Golden MR, Sex Transm Dis 2007;598-603). The intervention has two components: 1) promotion of patient delivered partner therapy (PDPT) use by medical providers in accordance with Washington state guidelines; and 2) targeted provision of partner services. PDPT use will be promoted through education and by making medication packs for PDPT available statewide. Medical providers will refer selected persons with gonorrhea or chlamydial infection for partner services based on defined criteria associated with failure to ensure partners' treatment. The intervention will be instituted in four waves separated by 6-9 months. Each wave will include approximately 6 local health jurisdictions. The order in which health jurisdictions initiate the intervention will be randomly assigned. The study's primary endpoint will be the prevalence of chlamydial infection in women age 15-25 tested through clinics participating in the state's Infertility Prevention Project (IPP) and the incidence of gonorrhea among women as determined through public health reporting.


Eligibility Criteria:
With reference to the above question about sampling, we will measure PDPT use in a probability sample of persons with STD. Chlamydial prevalence will be measured in a sentinel population. Gonorrhea incidence will be based on public health surveillance.

Inclusion Criteria:

* All non-MSM with gonorrhea or chlamydial infection will be eligible for the study intervention.

Exclusion Criteria:

* MSM
Oral Nutritional Supplements Compared With Standard Diet in Postoperative Gastric Cancer Patients With Adjuvant Chemotherapy

Background: It is known that postoperative malnutrition remains inevitable for gastric cancer patients with adjuvant chemotherapy, which could have prejudicial influence on the compliance of subsequent adjuvant chemotherapy and survival of the patients. A multi-institutional prospective phase 2 study had demonstrated the efficacy of oral nutritional supplements (ONS) for gastric cancer patients undergoing gastrectomy. However, previous studies did not focus the gastric cancer patients with adjuvant chemotherapy. Thus, it is unknown whether the ONS could benefit the gastric cancer patients with adjuvant chemotherapy. A multicenter, phase 3 randomised controlled trial was conducted to compare the ONS with standard diet for postoperative gastric cancer patients with adjuvant chemotherapy. Patients and method: In this study, pathological confirmed stage II-III or T1N1M0 gastric cancer patients who are supposed to receive adjuvant chemotherapy, aged from 18 to 75 years, with body mass index (BMI) from 18.5 to 28.0 kg/m2, and with Eastern Cooperative Oncology Group performance status ≤2, are randomized 1:1 to receive oral administration of NutrenOpimum (Nestle Suisse S.A.), a liquid enteral nutritional food for special medical purpose (FSMP), or standard diet. NutrenOpimum administration was recommended with a dosage of 400 kcal/400 ml per day within 7 days postoperatively and was continued for 3 months postoperatively. The primary end point was postoperative malnutrition, as defined as ratio of the weight loss at 3 months postoperatively to the days 7 postoperatively body weight (body weight loss ratio) higher than 10%; body weight loss ratio at 1, 3, 6 months. Secondary end points were chemotherapy withdrawal, time to adjuvant chemotherapy failure, period of adjuvant chemotherapy, quality of life, grade 3/4 neutropenia, thrombocytopenia, anemia, and severe side effects on digestive tract. Final study analysis will be conducted after the last patient's enrollment.


Eligibility Criteria:
Inclusion Criteria:

1. be proven to be primary adenocarcinoma of gastric cancer and pathological confirmed stage II-III or T1N1M0
2. age: 18-75 years
3. Eastern Cooperative Oncology Group performance status: 0\~2
4. body mass index: 18.5-28.0kg/m2
5. able to ingest semiliquid diet
6. without other malignancies with exception of the cured cervical carcinoma in situ and basal cell carcinoma
7. anticipated overall survival time ≥ 6 months
8. anticipated period of adjuvant chemotherapy ≥ 3
9. without severe mental disorder
10. without severe digestive disease
11. without Acquired Immune Deficiency Syndrome or diabetes mellitus
12. without communication barrier
13. informed consensus of patients

Exclusion Criteria:

1. with unstable hemodynamics
2. with severe nausea or vomit which cannot be controlled by drugs
3. allergic reaction to NutrenOpimum
4. dysfunction of other organs
5. with severe disease, such as infection, stroke, heart failure or stock
6. other situation to be judged not adaptive to the study by investigators
Macroscopic and Molecular Changes in Knee Muscular - Tendon Unit in Response to Acute Resistant Load

The aim of this study is to determine whether individuals differ one from the other in their genetic, cellular, systemic, structural and functional response to acute exercise.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Unhealthy adults
Mckenzie and Rhythmical Stabilization Technique on Chronic Neck Pain

The study will be randomized clinical trial. Total 40 subjects will be assigned randomly by using non probability convenient into two groups. Group A will be given McKenzie protocol, with conventional physiotherapy treatment while Group B is Rhythmic stabilization group who will receive rhythmic stabilization, with conventional physiotherapy. After confirmation of diagnosis with medical history and physical examination numeric pain rating scale (NPRS) and Neck disability index (NDI) would be used as an outcome measure tools for pain and disability respectively. Measure will be taken by goniometer. After data collection from defined study setting,data will be entered and analyzed at Riphah International University, Lahore.

Neck pain is a very common ailment that results in a great deal of suffering, impairment, and financial expense. The International Association for the Study of Pain is defined as Pain perceived as arising from anywhere within the region bounded superiorly by superior nuchal line, inferior by an unoriginally transverse line through the tip of first thoracic spinous process, and laterally by sagittal plane tangential to the lateral border of neck. According to the study's findings, 69% of Balochistan University undergraduate students in Quetta, Pakistan, experienced neck pain. Pain in many cervical spine structures has the potential to become chronic neck pain. In epidemiologic research, pain is considered chronic if it lasts more than three months to six months, or five years.

McKenzie's treatment regimens were first used in Sweden in 1985 to address mechanical spine patient issues. For these kinds of patients, protocols were often employed in the 1990s. Repeated neck retraction exercises considerably lessen the pain and restore the cervical spine's lordosis curve in individuals with spinal pain.

Rhythmic Stabilization is characterized by isometric contractions against the resistance provided by the therapist, with the subject trying to maintain their position as the therapist changes the direction of resistance. Both techniques are effective in pain and range of motion in chronic neck pain.

McKenzie protocol and rhythmic stabilization are both studied individually before but their effects are not compared previously.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-50
* Localized chronic neck pain for more than 3 months.

Exclusion Criteria:

* Participants suffering their neck pain was caused by any other complications.
The Effect of Expressive Touch and Music Applied After Lumbar Disc Hernia Surgery.

Patients undergoing lumbar hernia surgery will be divided into expressive touch, music and control groups. Pre-test and post-test pain levels, vital signs, and NIRS values of the patients will be measured.


Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the research,
* General anesthesia applied,
* Patients with the same type of treatment protocol,
* Verbal pain score with at least 4,
* Patients with a Ramsay sedation Scale score of 3 and below,
* Without a chronic disease,
* Without a disease (AVM, blockage of brain vessels, etc.) that will affect brain oxygenation,
* Who has not been diagnosed with any psychiatric illness
* No hearing and perception problems,
* No loss of sensation in upper extremity according to light touch test,
* Any complications after surgery are undeveloped

Exclusion Criteria:

* Do not meet the inclusion criteria,
* Interrupting the research,
* Patients with incomplete answers to questions
Prospective Evaluation of the Impact of Pre-operative Device on the Personal Experience of Brain Awake Surgery

The brain awake surgery has recently boomed in neurosurgical oncology but also in epilepsy surgery. The goal of awake surgery is to allow a more precise localization of sensorimotor functions, languages and cognitive to better respect them. Indeed, the interindividual anatomo-functional variations, the lack of specificity of functional explorations radiological magnetic or nuclear, as well as the reorganization of the areas involved in these functions (mechanisms of brain plasticity) in epileptic patients or patients with cerebral tumor do not allow to identify them in preoperatively. Brain awake surgery allows an analysis and a precise real-time identification of areas and networks involved in these functions through a direct electrical stimulation (inhibitory or activatory). Thus, this surgical technique has become a gold standard in surgery of brain lesions located in functional areas.

However, although the brain awake surgery has been practiced since many years, the confidentiality of these informations until recent years explains probably that very little data to be available on the personal experience of this procedure by patients. Studies that have analyzed the perception of the patient or the satisfaction of the patient after surgery in awake conditions were retrospective and included few patients. The investigators experience of lived of this surgery that the investigators have developed in the investigators team since over four years is that on the whole awake surgery is well tolerated if adequate explanations are provided preoperatively and if a minimum of preoperative precautions are observed.

Thus, the investigators have decided to develop a preoperative device that could improve personal experience and well-being of patients undergoing this surgical approach.


Eligibility Criteria:
Inclusion Criteria:

* Subject with a low grade glioma targeted for intervention in the awake brain surgery;
* Subject able to complete a self-administered questionnaire;
* Subjects who have signed a written informed consent and agreeing to abide by the instructions of the protocol

Exclusion Criteria:

* Minor, pregnant or lactating women, not affiliated to the social security system;
* Subject severe respiratory failure;
* Subjects treated with antipsychotic (neuroleptic or lithium);
* Subjects with cognitive impairment degenerative previously documented (Alzheimer, dementia other);
* subject active addict;
* Subject with personal psychiatric history;
Comparison of the Effects of Sevoflurane and Midazolam Used for the Maintenance of Anaesthesia on the Levels of Postoperative Cardiac Troponin I in Pediatric Cardiac Surgery

The purpose of this study is to compare two different anaesthetic agent effect on postoperative Troponin I levels in pediatric cardiac surgery


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective pediatric surgery
* Patients written informed consent for study participation

Exclusion Criteria:

* Redo surgery
* History of myocarditis
* Renal failure
* Pulmonary embolism
* Hypothyroidism
Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE

The PREVUE-VALVE study will establish reliable, population-based estimates of Valvular Heart Disease (VHD) prevalence among older Americans and allow for the development and validation of several innovative tools to aid in the detection and diagnosis of Valvular Heart Disease (VHD).

With the aging population, the incidence and prevalence of VHD are increasing in the U.S. and other parts of the developed world. Despite the availability of effective therapies and procedures to treat VHD, many patients remain (1) untreated due to undiagnosed VHD, or inadequate access to appropriate VHD care or (2) treated later than recommended due to diagnosis late in the disease course or barriers to prompt care for VHD. To optimize care for patients with VHD, it is therefore essential to (1) know the true prevalence of these conditions in order to align screening efforts with access to treatment; and (2) develop validated tools to more effectively screen and diagnose patients with VHD.

In response to these unmet needs, the PREVUE-VALVE study will establish reliable, population-based estimates of VHD prevalence in the United States and allow for the development and validation of several innovative tools to aid in the detection and diagnosis of VHD. The results of this study will enable the investigators to make tangible progress toward the goal of treating all patients with VHD at the optimal time.

The study will be conducted in a sample of older individuals (i.e., age 65-85 years) that is representative of the U.S. population. The sample will be carefully curated to ensure traditionally underrepresented individuals are included and overrepresented, if possible. After obtaining informed consent, each participant will undergo a standard echocardiogram in order to identify VHD (specifically aortic, mitral, and tricuspid valve disease) and to quantify its severity using state-of-the-art methods in a core echocardiography laboratory. Echocardiograms will be performed in participants' homes in an effort to reduce any barriers towards participation. A variety of complementary data (i.e. blood sample, electrocardiograms, and clinical inventory including a standardized health status assessment) will be collected while study personnel are with participants. Formal statistical weighting methods will be applied to estimate the population prevalence of various subtypes of VHD (e.g., aortic stenosis, mitral regurgitation) from the raw data. In addition, the investigators will report the prevalence of VHD, including VHD subtypes, and describe the association between different blood analytes and ECG characteristics with VHD.

Eligibility Criteria:
Inclusion Criteria:

* Age 65-85
* Ability to provide informed consent
* Stably domiciled in a residence that can be accessed by study personnel

Exclusion Criteria:

* History of complex congenital heart disease
Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness

The investigators have now established a technique to measure enamel thickness which has been shown to work well in-vitro. The teeth tested so far, obtained from the Dental School Tissue Bank, have been molars or pre-molars. In these cases, the measurement is made more difficult by the curvature of the tooth surface and it seems likely that flatter larger, incisors would give more satisfactory results. The investigators therefore wish to establish in-vivo whether this hypothesis is correct.

The aim is translate our research into a clinical hand-held dental tool that could be used to measure enamel thickness in less curvaceous anterior incisor (front) teeth, and ultimately monitor erosive tooth surface loss (TSL), which mainly occurs on anterior (front) teeth and the occlusal (top) surface of posterior (back) teeth. In this study, quantifying enamel thickness with ultrasound will provide data which will be assessed for reproducibility and to determine whether or not ultrasound is a potentially viable tool to measure and monitor acid erosion of teeth. This would allow dentists to reinforce advice to patients to reduce acidic consumption, and will motivate them to keep whatever is remaining of their 'precious' enamel tissue, which if lost, will necessitate fillings to be made. These fillings will require future repairs and possible remakes, as they have median survival rates of five years.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults over 18 years (females and males) with normal salivary flow.
2. Volunteers with absence of dental caries and/or periodontal disease on the maxillary incisors (upper front teeth) to be used in the study.
3. Volunteers should have sound maxillary incisors with no obvious cracks in the crown.
4. Volunteers who willingly signed an informed consent.
5. Volunteers who are willing to follow the research schedule for the period of the study.

Exclusion Criteria:

1. Volunteers with abnormal enamel on maxillary incisors assessed by visual inspection.
2. Volunteers with replaced enamel on maxillary incisors (eg fillings, crowns, bridges).
3. Volunteers who appear to have hypoplastic teeth as part of a syndrome, e.g. osteogenesis imperfect.
4. Volunteers having orthodontic appliances on front teeth, or presence of fixed or removable dentures (replacing missing front teeth).
5. Volunteers who have a complex dental history such as periodontitis, dentine sensitivity or salivary dysfunction.
6. Volunteers who have any condition could be expected to interfere with the volunteer's safety during the study.
7. Volunteers who demonstrate an inability to comply with study procedures.
8. Signed informed consent not obtained by the volunteer.