cyrilzakka/clinical-trials huggingface dataset:
Speech Adaptation When Using Mouthguards

The aim of this study is to evaluate the speech performance of professional rugby players when using custom-fitted mouthguards over a six-month period. Consented players will be given custom-fitted mouthguards and they will be instructed on the use and care of the mouthguards. At five time points: baseline, immediately following mouthguard use (T1), one-week after- (T2), one-month after- (T3) and six-month after use (T4), participants are required to pronounce four selected phonemes. Three recordings will be made for each phoneme. Spectrspectrographic analysis will be performed to assess the acoustic characteristics of the sound. Concurrently, they will be asked to fill up a questionnaire on self-assessment of oral impairments. Throughout the six-month period, the compliance of wearing mouthguards and the occurrence of dental trauma during training will be monitored on-site by the researcher or if not available, an assigned coach. A 24-hour helpline will be provided as a surveillance tool to monitor problems with mouthguards and dental trauma.

Rugby exposes players to increased risk of dental trauma. Thus, mouthguard use is recommended to provide a resilient surface for shock absorption and impact dissipation. However, some discontinued using mouthguard complaint that general discomfort and speech disturbance are the main barriers to their compliance. The nuisance is largely due to their use of poorly-fitted stock or boil-and-bite mouthguards. Therefore, the primary objective of this study is to evaluate speech adaptations when using custom-fitted mouthguards. The secondary objective is to assess the incidence of dental trauma within the six-month duration of mouthguard use. A prospective study will be carried out at the National Sports Institute. During the first day (T0), a workshop on the prevention and management of dental trauma will be carried out. Then, dental examination, dental impression, and recording of baseline speech performance will be performed. During the second visit (T1), mouthguards delivery, self-assessment of oral impairments, and speech recording will be carried out. After 6-months of monitoring (T2), all participants will be called again to fill in the self-assessment form and final speech performance will be recorded. Data analysis will be carried out to evaluate the self-assessment of speech performance and digital sonography of speech recordings over time. Also, the incidence of dental trauma will be reported.

Eligibility Criteria:
Inclusion Criteria:

1. Men aged between 18 and 35;
2. Actively playing rugby;
3. Currently playing in Malaysia Rugby Union;
4. Native speakers of Malay (national language), with the ability to read and write in Malay fluently; and
5. Without any history of either speech or hearing impairment.

Exclusion Criteria:

1. Retired players;
2. National players who did not play rugby within the last six months of the recruitment date; and
3. Players with cleft lip and/or cleft palate; and
4. Players with any history of either speech or hearing impairment.
Comparison of Simple and Continuous Suture Techniques in Oral Surgery

The study aims to compare two different suture techniques regarding wound healing. In this research, which is designed as a prospective study, a comparison of simple and locked continuous suture techniques will be done. For this purpose, Selçuk University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, being treated at the full arch flap opened (for alveoplasty). Half of the arch will be closed by a simple suture. The other half will be closed by continuous suture technique.

It is planned to evaluate wound healing with the Landry Healing Index and Early Wound Healing Score. It is planned to measure the amount of knot looseness in millimeters on the 7th day when the sutures will be removed. On the 7th day, it is planned to evaluate the suture removal pain for the patient and the ease of suture removal for the operator with the VAS scale. Data collected from these assessments will be statistically compared for simple and continuous sutures.


Eligibility Criteria:
Inclusion Criteria:

* Needing full arch alveoplasty
* No smoking

Exclusion Criteria:

* Uncontrolled systemic condition
* Not participating in control appointments
* Complications about wound healing
Postoperative Pain and Discomfort After Orbital Decompression

The purpose of this study is to evaluate the postoperative pain and discomfort using flurbiprofen axetil or nalbuphine administration after orbital decompression under general anesthesia.

To investigate postoperative analgesia achieved with intraoperative administration of intravenous nalbuphine and flurbiprofen axetil in patients undergoing orbital decompression

Eligibility Criteria:
Inclusion Criteria:

* 16-75 years old
* diagnosed as thyroid eye disease
* bone removal orbital decompression under general anesthesia
* American Society of Anesthesiologists (ASA) physical status of I-II

Exclusion Criteria:

* body mass index (BMI) \<18.5 or \>35
* any uncontrolled clinical problems
Perception of Blood Sugar Variations During Physical Activity in Healthy Subjects and Type 1 Diabetes Patients

Type 1 diabetes is an autoimmune disease with absence of insulin secretion. Blood sugar is a physiological variable that reflets for blood glucose concentration. Blood sugar level fluctuates, especially during physical activity.

Sports activity would increase insulin sensitivity, improve lifestyle and, by extension, promote glycemic balance. However, glycemic balance will be disturbed by physical activity with higher risk of hypoglycemia and hyperglycemia.

Moreover, hypoglycemia and hyperglycemia will impact body functions. Perceptions of blood sugar variations during physical exercise and their influences on sports performance have not been studied, whether in type 1 diabetes patients or healthy subjects.

The aim of the study is to evaluate the perception of blood sugar variations in healthy subjects and type 1 diabetes patients during physical activity

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetics diagnosed more than 3 years ago and controlled (an HbA1c of less than 8%) for "type 1 diabetes" group
* without diabetes for "healkthy" group
* Male
* Aged 18 to 65
* Body Mass Index less than 30 kg/m2
* regular running (at least 30 minutes per week and at least one 10-km run per year for the previous 2 years)
* Agreeing to participate in the study

Exclusion Criteria:

* Physical injury
* beta blockers treatment
Hi-Fatigue G Bone Cement Retrospective Study

The objective of this retrospective monocentric study is to collect survivorship and clinical data confirming safety, performance and clinical benefits for the Hi-Fatigue G Bone Cement.

The assessments will include:

* Radiological analysis performed at different time points according to the standard of care of the hospital
* Implant survivorship and safety based on removal of a study device
* Patient reported outcome measures (PROMs)

Primary endpoint:

Assessment of radiolucent lines around the components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care).

Secondary endpoints:

* Evaluation of implant survivorship and safety by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
* Evaluation of PROMs
* Obtain information regarding the cementing technique and handling of the cement, if available


Eligibility Criteria:
Inclusion Criteria:

* Subject qualified for cemented TKA or THA with a Zimmer Biomet implant
* Subject is willing and able to give written informed consent for retrospective data collection and undergo interim and final evaluation (X-Ray \& Scores completion)
* Subject \> 18 years old

Exclusion Criteria:

* Muscle wasting
* Neuromuscular compromise in the affected limb
* Known hypersensitivity to any of the cement constituents
* Subjects with severe renal failure
* Bilateral interventions
* Subject is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, known alcohol or drug abuser, anticipated to be non-compliant)
Effects of an Oxalate Containing Product on Dentinal Hypersensitivity With Dental Prophylaxis

This study will assess sensitivity during a dental prophylaxis with or without the use of a potassium oxalate salt solution.


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age
* sign an informed consent form and be given a copy
* be in good general health as determined by the Investigator/designee
* agree to delay any elective dentistry, and to report any dentistry received during the course of the study
* agree to not participate in any other oral care study for the duration of this study
* agree to return for scheduled visits and follow all study procedures
* have at least one tooth with a Schiff sensitivity score of at least 1 in response to air challenge and a Yeaple Probe score of 10-40 in response to tactile challenge.

Exclusion Criteria:

* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
* active treatment for periodontitis
* any diseases or conditions that might interfere with the subject safely completing the study
* inability to undergo study procedures
* fixed orthodontic appliances
Reperfusion Time in ST Segment Elevation Myocardial Infarction (STEMI)

Reperfusion delay in STEMI has been shown to be excessive in our community. In order to improve delay a fast track (direct transfer in catheterization laboratory) has been implemented. The present study aims at evaluating the benefits of this procedure.

Reperfusion delay in STEMI has been shown to be excessive in our community. Admission in emergency room and waiting for transfer to catheterization laboratory seems to be the principal source of delay. In order to improve delays a fast track (direct transfer in catheterization laboratory) has been implemented for patients being diagnosed with STEMI by emergency physician out of hospital. The present study aims at evaluating the benefits of this procedure.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of STEMI

Exclusion Criteria:

* On site resuscitated patients
Feasibility Study of i-ACT in Aged Persons

A mix-method cross-sectional feasibility study performed in five aged care institutes in Flanders, Belgium. A convenience sample of 48 aged persons was recruited and 12 supervisors (i.e. occupational therapy students and therapists).

Aged persons received a 20-30 minutes test with a technology-based system, i.e. intelligent Activity-based Client-centred Training system (i-ACT). The i-ACT consists of the Microsoft Kinect and adapted software in which movements can be recorded and training parameters can be set by supervisors.

During and after the test, the thinking aloud method was used. After the test, the Intrinsic Motivation Inventory, the System Usability Scale, and the Credibility/Expectancy Questionnaire were administered in the aged persons.


Eligibility Criteria:
Inclusion Criteria:

* a client of the participating centres
* cognitively able to understand and respond to questions
* follow up instructions
* understand and speak the Dutch language

Exclusion Criteria:

* severe spasticity that unables participants to perform exercises
* severe visual impairment (e.g. blindness, cataract, etc.)
* severe communication disorder that unables participants to understand and follow up instructions (e.g. aphasia, agnosia, etc.)
* persons who use electric wheelchairs who are not able to make a transfer towards a chair.
Inspiratory Muscle Training, Autonomic Dysfunction and Blood Pressure

This study finds the effectiveness of inspiratory muscle threshold loading training among adults with hypertension. A sample of hypertensive subjects was divided into two groups - inspiratory muscle training (IMT) - group (inspiratory muscle training was prescribed) and sham-group (no load was prescribed during IMT). Both groups had training sessions comprising seven cycles of two minutes bouts of breathing counter to an inspiratory load, each bout parted by one minute of unloaded recovery. Treatment session was performed for three times per week for a total of six weeks. Measurement of each of the variables (blood pressure, resting heart rate (RHR), heart rate variability (HRV)) was taken at baseline and after the six-week intervention.

The present study aimed to examine the outcome of interval inspiratory muscle training at 70% load on blood pressure, resting heart rate and autonomic dysfunction in the hypertensive adults.

Participants were divided into two groups: IMT and sham. In IMT group, the threshold loading inspiratory muscle trainer from POWERbreathe was used with 70% IMT threshold. In Sham group, IMT was unloaded.

Eligibility Criteria:
Inclusion Criteria:

* stage 1 hypertension
* essential hypertension
* mild hypertension

Exclusion Criteria:

* Subjects participating in exercise training for more than the last six months
* severe musculoskeletal limitations
* severe neurological limitations
* cognitive impairments
* uncontrolled diabetes
* uncontrolled hypertension
* a history of myocardial infarction (MI)
* a history of stroke in the last six months
* unstable angina
* chronic heart failure
* pulmonary disease of any etiology
Identification of the Best Self-questionnaire to Diagnose Depression in Patients With Psoriasis (DePsoVal)

Prevalence of depression shows great heterogeneity in patients with psoriasis. This could be explained by the psychometric properties of the questionnaires assessing depressive symptoms: these tests have not been developed in a context of dermatosis. The complaints and symptoms associated with psoriasis can be misidentified by questionnaires as a manifestation of depressive symptomatology and may overestimate depressive symptoms.

In other diseases such as asthma and rheumatoid arthritis, tools have been validated specifically to take into account these symptoms.

The purpose of this study is to validate and compare assessment tools for depression in patients with psoriasis.

The study does not modify the management of patients. Patients will be contacted by phone. The protocol, the modalities and the objectives of the study will be presented during a first telephone interview. A second telephone interview will be scheduled with the patient 3 days later for the collection of his informed consent, if he agrees to participate, and the completion of the questionnaires of the study. The online questionnaires will be sent by email during this call.

1. Telephone interview (5 minutes) Presentation of the study. Schedule a telephone appointment 3 days later.
2. Telephone interview (10 minutes) Collection of consent. Sociodemographic questionnaire: sex, age, marital status, level of education Medical questionnaire including the consumption of tobacco and alcohol, the collection of current treatments, their indications and their start dates.

   Semi-directed telephone interview to identify the presence of depressive or dysthymic disorders (MINI).
3. mailing of the self-questionnaires (20 to 30 minutes) Medical questionnaire: duration of psoriasis, simplified index of psoriasis, presence of pruritus, pain EVA (cutaneous and articular), fatigue.

   Self-questionnaires BDI, PHQ9, IDS, QIDS, HADS assessing the intensity of depressive symptoms.
4. Retest (10 minutes) Some patients will be offered to re-fill the self-questionnaires assessing the intensity of depressive symptoms 15 days after completion of the survey. All participants selected for the retest will not complete all questionnaires again: the questionnaires will be distributed among the patients. The retest requires 50 patients who declare themselves stable (identified by one item) for each questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Major patient, male or female, with psoriasis, less than 65 years old, followed up in the dermatology or rheumatology departments of the University Hospital of Clermont-Ferrand.
* Able to mentally and linguistically answer the proposed questionnaires.
* Can fill out online questionnaires from his home.
* Affiliated with Social Security.

Exclusion Criteria:

* Major incapable patient
* Refusal of participation
Tele-diagnostics for Remote Parkinson's Monitoring

The purpose of this research study is to design, implement, and clinically assess a portable, user worn system for monitoring Parkinson's disease (PD) motor symptoms. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a subjective, qualitative ranking system. The main goal of this research is to develop a quantitative system, Kinesia HomeView, to assess tremor as well as different features of bradykinesia in a home based system which can capture those symptom changes over the course of a day and aid in evaluating treatment protocol efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease

Exclusion Criteria:

* Inability to follow the required clinical instruction
* Subjects with cognitive impairments that would prohibit them from properly using the Kinesia HomeView system
* Subjects without the cognitive ability to respond to researchers and let them know when any parameters of the study may become uncomfortable
* Subjects found on examination by our clinicians to have any physical limitations which would be counter productive to participation in this study.
ModuLAAr - A Module Based and Scalable System for Silver-ager in Austria

In this research project a module based Ambient Assisted Living solution will be provided to elderly living in assisted living homes. Those products and services seek to impact quality of life of the elderly and have positive effects on their environment.


Eligibility Criteria:
Inclusion Criteria:

* 60 years and older
* informed consent
* resident of an assisted living home of the Samariterbund Burgenland Rettung und Soziale Dienste GmbH

Exclusion Criteria:

* relevant health threatening event or death
* mini mental state score \<17
Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy

This is proof of concept, phase I randomized controlled trial studying a short acting non-opioid anesthetic, bupivacaine to improve post-operative pain in gynecologic surgery patients. Patients who are undergoing minimally invasive (laparoscopic or robotic) hysterectomy will be randomized to receive no uterosacral injection, normal saline uterosacral injection, or 0.25% bupivacaine uterosacral injection just prior to colpotomy (incision around the cervix and removal of uterus) during minimally invasive hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 18 years old
* undergoing benign minimally invasive hysterectomy with minimally invasive GYN surgeon at Johns Hopkins Hospital
* Patients must be English speaking.

Exclusion Criteria:

* Pregnancy
* allergy, contraindication, or intolerance to bupivacaine, opioids, Tylenol, or NSAID drugs
* pre-operative daily opioid consumption
* peri-operative transverse abdominis plane block
* recent history of drug or alcohol abuse (in last year)
* severe cardiovascular, hepatic or renal disease.
Evaluation of a New Eye-specific Multivitamin Formula in Participants at Risk of Age-related Macular Degeneration (AMD)

The aim of this study is to evaluate the clinical benefits in visual function from dietary supplementation of the Lumega-Z carotenoid liquid-supplement in participants with drusen and at risk of AMD. The effects of Lumega-Z supplementation will be compared to an active comparator, the AREDS2 multivitamin.


Eligibility Criteria:
Inclusion Criteria:

- patients with retinal drusen (as determined by clinical fundus photography examination) and dark adaptation recovery time of 6 to 10 minutes.

Exclusion Criteria:

* presence of congenital retinal pathologies that may impact data collection
* prior history of retinal-detachment or vitreo-retinal surgeries with any complications
* best-corrected visual acuity of 20/40 or worse
The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue

This study is being done to determine if the acute administration of the drug Simvastatin reduces plaque tissue inflammation and plaque instability in patients undergoing carotid endarectomy


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing carotid endarterectomy
* No previously known side effects of statins
* Patients who will sign an informed consent
* Age \> 18 years old
* No signs of current infection

Exclusion Criteria:

* Patient hypersensitive to any component of this medication
* Patients with acute liver disease (AST\> normal value)
* Patients with chronic liver disease (history of Hepatitis B or C)
* Patients with renal failure (creatinine \> 3.0)
* Patients with unexplained muscle pains and aches
* Patients with rheumatoid arthritis
* Patients with Lupus
* Current cancer treatment
* Patients on cyclosporin, digoxin, Itraconazole, Ketoconazole and other antifungal azoles, the macrolide antibiotics and antidepressant nefazodone
* Pregnant females
Exercise or Relaxation for Smoking Cessation

This research study is being done to find out if adding a moderate exercise program or a relaxation program to a smoking cessation treatment program will improve smoking cessation and health in postmenopausal women. We hope to learn which group is more successful at quitting, has less symptoms of withdrawal from smoking and has improved health.

Prevalence of smoking among women has declined more slowly in women than among men. Women who quit smoking substantially reduce the risk of premature death. A multi-modal approach to smoking cessation with combined behavioral and pharmacological interventions generally yields the highest success rates. The majority of subjects who are able to achieve abstinence return to smoking. Smoking relapse rates are 50-80% within one year with the majority of smokers relapsing within the first 3 months. Interventions are needed to both enhance smoking cessation rates and prevent relapse rates in order to substantially impact long-term quit rates.We intend to compare the effectiveness of a smoking cessation program combined with a moderate exercise program to an identical smoking cessation program combined with a relaxation-meditation control condition.

In a substudy, we will also evaluate the effectiveness of the intervention in premenopausal women (N=40)

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women at least 45 years of age
* Smoking at least 10 cigarettes per day
* Motivated to quit smoking
* Ambulatory
* Currently exercising for 90 minutes of moderate exercise or less per week
* Motivated to exercise
* Permission from Primary Care Provider
* Good general health

Exclusion Criteria:

* Denied medical clearance from primary care provider
* Unstable angina or uncompensated heart failure
* Systolic blood pressure greater than 165 or diastolic blood pressure greater than 100
* Heart attack or stroke within the preceding 6 months
* Hip fracture within the preceding 6 months
* Unstable medical or psychiatric disorder (e.g., current major depressive disorder or substance abuse or dependence)
* Exercise-exacerbated neuromuscular disorder
* Treatment for depression within the last year
* Estimated creatinine clearance of less than 30cc/minute
* Current use of a smoking cessation aid (i.e., bupropion, NRT, clonidine)
* Current use of psychotropic medication for a psychiatric problem
* Prescription narcotic abuse or dependence with the exception of people that have been stabilized on Methadone Maintenance or Suboxone
* Previous serious adverse event with Chantix use