cyrilzakka/clinical-trials huggingface dataset:
Pain, Central Sensitization, Kinesiophobia and Stress Level in Individuals with Temporomandibular Dysfunction

Temporomandibular dysfunction (TMD) is a musculoskeletal and neuromuscular system-related condition that affects the masticatory muscles, temporomandibular joint, and other related structures. Recent research has focused specifically on pain catastrophe, kinesiophobia, and central sensitization in individuals with TMD. Therefore, the aim of this study is to examine the relationship between pain, central sensitization, kinesiophobia and stress level in individuals with temporomandibular dysfunction.

Temporomandibular dysfunction (TMD) is a musculoskeletal and neuromuscular system-related condition that affects the masticatory muscles, temporomandibular joint, and other related structures. Psychological factors are stated as comorbid in individuals with TMD. Individuals with TMD-related pain show higher levels of stress, anxiety, depression, somatic awareness, pain catastrophizing, and kinesiophobia compared to controls. Therefore, recent research has focused on pain catastrophe, kinesiophobia, and central sensitization, especially in individuals with TMD. Therefore, the aim of this study is to examine the relationship between pain, central sensitization, kinesiophobia and stress level in individuals with temporomandibular dysfunction. Ninety patients aged 18-65 years, who have TME-related complaints for at least 3 months, and diagnosed with TMD as a result of clinical and radiological evaluation by a dentist will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-65,
* Having complaints related to TMJ for at least 3 months,
* Patients diagnosed with TMD as a result of clinical and radiological evaluation by the dentist

Exclusion Criteria:

* Cognitive problems,
* Any systemic joint or muscle disease (e.g. fibromyalgia, rheumatoid arthritis),
* Serious systemic diseases,
* Any neurological disorder (e.g. trigeminal neuralgia),
* Pregnancy, breastfeeding status,
* Previous treatment for TMJ or orofacial muscle pain
Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients.

Oral mucositis is one of the most spread side effects of anticancer therapy. It is associated with both chemo- and radiotherapy, decreases QoL, relative dose intensity and leads to nutritive deficiency. Oral mucositis causes secondary infections, increased hospital stay, whereas pain syndrome results in an emotional distress, anorexia and disables natural feeding.

Primary:

To evaluate the efficacy of ONCOXIN on oral mucositis symptoms in patients who receive chemotherapy and/or radiotherapy.

Secondary:

To evaluate the effects of ONCOXIN on nutritional status in patients who receive chemotherapy and/or radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. A signed and dated informed consent form;
2. Patients of both genders, aged 45-75;
3. Malignant neoplasms which have radio-, chemotherapy or their combinations prescribed;
4. ECOG ≤3;
5. WHO oral toxicity scale grade 2 - 3.

Exclusion Criteria:

1. Significant, according to the investigator judgement, concomitant diseases or states which make it complicate or even impossible the patient's participation in the study or make it difficult to interpret the clinical data obtained in any stage of the study always including the following:

   * Mental disorders;
   * Serious/chronic infectious and parasitic diseases;
   * Intolerability to any of ONCOXIN components.
2. Relations with study center personnel (study center staff or family member of the investigator, coordinator or assistant).
3. If the patient fails to assess his/her physical and emotional condition;
4. If the patient fails to comply with the requirements;
5. Patient's refusal to participate in the study;
6. Pregnancy or lactation.
Smartwatch Paroxysmal Arrhythmia Detection Compared with Holter

The lifetime risk for development of atrial fibrillation, the commonest sustained arrhythmia in adults, is estimated to be 24%-27% for individuals of 40 years or older. Previous work showed that annual new diagnosis of AF is 11000-26000 in Hong Kong. Other arrhythmia such as supraventricular arrhythmia or premature beats were also common and of clinical significance.

12-lead ECG is a first line investigation for patients with suspected paroxysmal arrhythmia, but it has a low diagnostic yield with its 10-30 seconds recordings. 24-hour Holter exam is the usual next step of diagnosis. The diagnostic yield of Holter varies according to indication but is generally low at 1%-12%. This is because paroxysmal arrhythmia may not happen every day. In addition, even if arrhythmia is picked up in Holter, patient may not register the symptom, making the symptom arrhythmia correlation problematic.

Despite limitations, the demand for Holter exam is still high. In Prince of Wales Hospital, a tertiary referral centre with a catchment of about 1 million populations, the waiting time for a routine Holter exam is 3 years.

Smartwatch has gained popularity over past years as an adjunct to smartphone. Latest generations of smartwatch were equipped with wearer-initiated ECG rhythm strip recording capabilities. Smartwatch has evolved to become a health tracker with arrhythmia detection capabilities. It was found to be a useful tool for atrial fibrillation screening in general population. Other arrhythmias, such as supraventricular tachycardia, premature beats, and abnormal ECG patterns associated with sudden cardiac death could also be detected with smartwatch ECG recordings. Apple Heart study was the largest study utilizing smartwatch for arrhythmia detection. The general population was screened for atrial fibrillation using irregular pulse algorithm. The study found a 84% concordance rate between irregular pulse notification and ECG patches.

Therefore, investigators propose to conduct a study to compare its diagnostic yield with Holter, in patients with suspected arrhythmia and see if smartwatch recording following a systematic protocol for four-weeks will have better arrhythmia diagnosis yield than a 24-hour Holter exam.


Eligibility Criteria:
Inclusion Criteria:

1. All patients referred for out-patient Holter exam from age 18 - 80 years old
2. The following indications for Holter exam will be allowed for recruitment

   * Palpitation
   * Pre-syncope
   * Dizziness

Exclusion Criteria:

1. Patients with a prior ECG diagnosis to explain the symptom
2. Primary symptom is syncope
3. Patient who has no clear indication for Holter exam
4. Pregnant ladies
5. Patients who failed to make a successful recording despite teaching attempts.
6. Patients who cannot read English or Chinese version of consent.
7. Anticipation of non-compliance with recording protocol.
8. Patients who do not have a compatible smart phone (Android 9.0 or newer, or iOS15 or newer)
9. Patients under custody
Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects

Obesity is an important public health problem in the United States. The investigators hypothesize that stomach injections of botulinum toxin A (BTA), delivered through an endoscope using endoscopic ultrasound (EUS), may cause delayed gastric emptying, satiation, and reduction in body weight. This protocol is designed to study the effects and safety of gastric BTA injections. Subjects are randomized to receive placebo or one of two different doses of BTA injected into the stomach during one endoscopy, performed via the mouth. Gastric emptying, satiation, symptoms, psychological dimensions of eating behavior, and caloric intake are recorded before and after injections, and subjects are seen in follow-up for 24 weeks.

Additional information regarding study interventions can be obtained by contacting study staff.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 60 years
* BMI ≥ 35 kg /m²
* No history of diabetes, gastric or small bowel surgery, known gastroparesis, prior peptic ulcer, esophagitis, or gastrointestinal stricture.
* Not pregnant or nursing. Women of childbearing potential must have a negative urine pregnancy test within 48 hours prior to each gastric emptying study, and the Botox injection procedure.

Exclusion Criteria:

* Unable or unwilling to provide written informed consent
* ASA Class III or higher
* Chronic upper abdominal pain, nausea, or vomiting
* Allergy to botulinum toxin
* Delayed gastric emptying (abnormal T ½) on baseline scintigraphic gastric emptying test
* Active esophageal, gastric, or duodenal ulceration at time of diagnostic EGD
* Allergic to both penicillins AND quinolones
* Subject has taken warfarin (Coumadin) or clopidogrel (Plavix) in the week preceding EUS
Investigating the Immediate Effects of Kinesio Tape and Biomechanical Tape on Strength and Performance: A Randomized Placebo-Controlled Cross-Over Trial

There has been an increasing interest in Kinesiology Tape(KT) and Biomechanical Tape(BT) in clinics and athletic competitions. Recently; the performance increasing effect of taping methods on healthy subjects in sports is being investigated.

Kinesio Taping (KT) is a technique utilizing a two way elastic tape originally created by Kenzo Kase in the 1970s. KT is a complementary method which is used as an adjunct to major therapy approaches in various musculoskeletal and neurological diseases.4 KT is employed in sports injuries and various health problems; but there is limited scientific evidence evaluating KT effectiveness and the results are inconsistent.5 One of the KT potential benefits is that of raising the range of motion through increasing blood circulation or through stimulation of cutaneous mechanoreceptors and this way it affects fascial tissue.6-8 Biomechanical Taping (BT) is a technique utilizing a four way elastic tape originally created by Ryan Kendrick in the 2010s. BT is a complementary method for supplementing load absorption, force contribution and modifying movement. BT affects tissues and movement in a mechanical way and it is almost a completely different method from KT. Kase's hypothesis is that KT affects fascial tissues and mechanoreseptors, but Kendrick's hypothesis is that BT ,which is applied in shortened position and cross joint segments, will gain potential energy in case of an extremity realized movement with antagonist activity. Then the weak agonist muscle gets activated for repositioning the extremity; this potential energy turns to kinetic energy like a released bow. As a result of kinetic energy, it may support the movement with using passive mechanical strength.9 In this study, the investigators aim to illustrate immediate effects of various taping methods on the performances of healthy subjects. In that way the investigators test hypothesis that different taping methods affect healthy subjects to improve performance. The investigators; investigate strength, active range of motion and vertical jump height as a parameters of performance with No Tape(NT), Sham Tape(ST), KT and BT.

Eligibility Criteria:
Inclusion Criteria:

* 18-24 BMI
* Physically active according to International Physical Activity Questionnarie (IPAQ)

Exclusion Criteria:

* Any known systemic diseases or medical condition
* Sensitive or fragile skin,
* Allergic diseases
* Pregnancy or pregnancy suspicion
* Using of sedative, psychosomatic or analgesic drugs
Post Marketing Survey of Vesicare in Japan

This study is to evaluate the effect of Vesicare on quality of life (QOL) in female patients.

Overactive bladder (OAB) represents a constellation of symptoms that must include urinary urgency as an essential symptom for the diagnosis. It is usually accompanied by daytime frequency and nighttime frequency (urgency incontinence is not an essential symptom) and impairs the patient's activities of daily living and quality of life (QOL).

The objective of this survey is to confirm QOL improvement in patients treated with Vesicare (Generic Name: solifenacin succinate), with the use of OAB-q (Overactive bladder questionnaire), a questionnaire for assessment of OAB symptoms and QOL. The effect of improvement of OAB symptoms by solifenacin on QOL will also be confirmed. This survey will not include male OAB patients since many of them have benign prostatic hyperplasia as a coexisting disease and their QOL is supposed to be affected by α1-blocker treatment. To define patient's response to solifenacin in terms of QOL more clearly, this survey will include only female OAB patients.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated OAB patients
* Patients who meet the diagnostic criteria for OAB provided in the clinical guidelines for overactive bladder (patients who have urinary urgency at least once weekly as an essential symptom and at least one of the other OAB symptoms including daytime frequency, nighttime frequency, and urgency incontinence)
* Patients who can understand and answer OAB-q (Japanese version)
* Patients from whom data on all items concerning OABSS, OAB-q, and satisfaction score for urination can be obtained at baseline
* Patients who are expected to be treated for at least 12 weeks
The Effectiveness of Perioperative CPAP to Reduce Obstructive Sleep Apnea Related Adverse Events

Objective of the study: To determine whether Perioperative Auto-CPAP treatment prevent postoperative worsening of OSA and improve nocturnal oxygen saturation in surgical patients with moderate and severe OSA.

The patients will be approached by the study coordinators at the preoperative clinic. If the patient is interested in participating the study, STOP-Bang and Epworth questionnaires will be implemented to determine the risk for OSA.If the patients are classified as high risk of having OSA, they are scheduled for an overnight sleep study at home. The patients with Apnea-Hypopnea Index (AHI)\>15 from the sleep study will be randomized into two study groups: Perioperative CPAP group or control group (routine care). In the perioperative CPAP group, patients will be treated with auto-CPAP for 2-3 nights preoperatively and 5 nights postoperatively. All patients will undergo sleep study on the third postoperative night and be monitored by a pulse oximeter for 2-3 nights preoperatively and 5 nights postoperatively.

Eligibility Criteria:
Inclusion Criteria:

the patients who meet the following criteria will be recruited

* Patients who are scheduled for inpatient surgery that required a minimum of three nights of hospital stay
* Age: \>18 and \<80 years old.
* Identified as high risk of having OSA or diagnosed with OSA without using CPAP.

Exclusion Criteria:

* Undergoing nasal, eye, head/neck surgery, intracranial or cardiac/thoracic surgery.
* Unwilling or unable to give informed consent.
* Currently undergoing treatment for sleep apnea including CPAP.
* Requiring prolonged postoperative ventilation.
* New York Heart Association functional class III and IV.
* Having valvular heart disease, dilated cardiomyopathy, implanted cardiac pacemaker, or unstable angina.
* Having myocardial infarction or cardiac surgery within 3 months.
* Having chronic obstructive pulmonary disease, or asthma.
* Having a presence of tracheostomy, facial, neck, or chest wall abnormalities.
* Having abdominal aortic aneurysm surgery, chemotherapy, or immunosuppressive therapy within 3 months.
* Visiting preoperative clinic less than 3 days before scheduled surgery date.
* On nasogastric tube postoperatively.
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.

The objective of this trial is to assess the efficacy of reducing plasma low-density lipoprotein(LDL) cholesterol and safety in two different brand drugs, Roty F.C. Tablets 10mg and Crestor 10mg F.C. Tablets in hypercholesterolemia population.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 20 to 85;
* LDL - C between 130 mg/dL and 250 mg/dL;
* TG \< 400 mg/dL;
* Who without use of any statin within 2 week prior to the trial;
* Informed consent given.

Exclusion Criteria:

* Known hypersensitivity or history of SAE with another HMG-CoA reductase inhibitor, in particular any history of myopathy;
* Active liver disease/severe hepatic impairment(Child-Pugh C,ALT2×ULN);
* Treatment with Cyclosporin or any disallowed drug;
* Patients with unstable angina pectoris;
* Pregnant, lactating women;
* Patients who have severe medical condition(s) that in the view of the Investigator prohibits participation in the trial.
CRESTOR Athero Imaging Head to Head IVUS Study

A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for coronary angiography
* Angiographic evidence of Coronary Artery Disease (CAD), as defined by at least 1 lesion in a native coronary artery that has \>20% reduction in lumen diameter by visual estimation
* Left main coronary artery must have \<=50% reduction in lumen diameter by visual estimation
* LDL-C \>100 mg/dL (2.6 mmol/L) for patients with no statin therapy in the past 4 weeks; LDL-C \>80mg/dL (2.08mmol/L) for patients on therapy in the past 4 weeks

Exclusion Criteria:

* Use of certain lipid-lowering medication for more than 3 months within the previous 12 months. Longer periods of treatment are not permitted because of the potential effects of such therapy on coronary atherosclerosis.
* Patients who have symptoms consistent with moderate or greater severity of Congestive Heart Failure (CHF).
* Clinically significant heart disease which, in the opinion of the Principal Investigator (or designee), is likely to require coronary bypass surgery, cardiac transplantation, surgical repair and/or replacement during the course of the study
Acute Effects of a Stretching Program of the Rib Cage Muscles on Patients With COPD During Exercise

Investigate the effects of stretching the muscles of the rib cage in individuals with COPD during exercise.

To investigate the effects of a stretching program for the muscles of the rib cage or control in patients with COPD during exercise and / or the immediate post-exercise, using the following parameters:

* Tidal volume (VT), respiratory rate (RR), minute volume (MV), inspiratory time (Tins) and expiratory (T exp).
* Change in volumes of total and regional chest magazines (pulmonary rib cage, abdominal rib cage and abdomen).
* Diaphragmatic mobility.
* electrical muscle activity
* endurance time.
* Dyspnea sensation.

Eligibility Criteria:
Inclusion Criteria:

* Smoking history, occupational or environmental exposure to pollutants and / or symptoms of cough, dyspnea or hypersecretion;
* FEV1 \<80% predicted and post-bronchodilator FEV1 / FVC \<70% to confirm the diagnosis of airway obstruction not fully reversible bronchodilator therapy;
* Absence of co-morbidities that does not allow the realization of stress (hypertension, severe pulmonary hypertension, myocardial infarction, congestive heart failure, severe dyspnoea);
* Preserved cognitive functioning;
* Sedentary
* Clinically stable during the study period.

Exclusion Criteria:

* Patients with cognitive, hearing or visual deficit;
* Changes in the neuro-musculo-skeletal system which endangers or impairs the assessment;
* Obese
* Not be able to achieve at least three stages of the incremental test.
Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia

Cervical intraepithelial neoplasia will be treated with physical low temperature plasma in the plasma cohort compared to watchful waiting in the control cohort.

Primary endpoint after 3-6 months: Pathological remission.

Secondary endpoint: HPV remission.

The study was completed with Less recruitment as it was planned due to overwhelming study success. The study was published in August 2023. A link has been added to the Reference section.

Eligibility Criteria:
Inclusion Criteria for CAP:

* Histologically confirmed CIN I / II
* Reliable assessment of the radius of the portio and marginal borders of the lesions
* Written consent for treatment with low temperature plasma after reconnaissance

Inclusion Criteria for Control-Group:

* Histologically confirmed CIN I / II
* Reliable assessment of the radius of the portio and marginal borders of the lesions
* Patients who want a waiting procedure and a control examination after 3-6 months

Exclusion Criteria:

* Histologically confirmed CIN III
* Not fully visible transformation zone
* An indication of invasive disease
* Expected lack of compliance of the patient or incapacity of the patient to understand the meaning and purpose of the clinical trial
* Severe cardio-vascular disease
* Lack of patient consent
Improving Access to a Primary Care Based Positive Parenting Program

This is a randomized clinical trial of the impact of incorporating a peer mentor into a primary care based group parenting program on increasing program participation by parents and improving program outcomes.

The investigators will perform a randomized controlled trial of the impact of Child Adult Relationship Enhancement (CARE) plus peer mentor on increasing program adoption, acceptability, and appropriateness among 2-6 year old children and their parents at UNC Children's Primary Care Clinic. The investigators will also examine the effectiveness of CARE plus peer mentor on dysfunctional parenting and child behavior problems. Participants will be randomized to CARE plus peer mentor or standard CARE. Program attendance, acceptability, and appropriateness will be measured upon completion of the 6-week program. Dysfunctional parenting and child behavior will be measured at baseline and 6 weeks. The investigators will conduct semi-structured interviews among a sample of parents (\~20-30) in order to understand the impact of the peer mentors on program implementation, as well as barriers and facilitators to program initiation and long-term participation.

Eligibility Criteria:
Inclusion Criteria:

* 2-6 year old child at UNC Children's Primary Care Clinic and their parent
* English speaking

Exclusion Criteria:

* child is developmentally younger than 2 years old
* child is already received mental health services for behavioral problems
Soluble Beta-glucan (SBG) as Treatment for Diabetic Foot Ulcers

The purpose of this study is to determine whether the application of soluble beta-glucan (SBG) onto diabetic foot ulcers improves the healing of the ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetes mellitus
* Age ≥ 18 years
* One or more full-thickness ulcers at or below the level of the malleoli, which do not extend to tendon, joint, or bone
* The ulcer (or index ulcer, if appropriate) must have been present for at least 4 weeks prior to Day 0 but not longer than 2 years
* Ankle:brachial pressure index (ABPI) \>0.7, or the presence of two palpable pulses on the affected foot
* Ulcer area \>25 mm2 but \<500 mm2
* Written informed consent

Exclusion Criteria:

* Pregnancy, lactation or absence of adequate contraception for women with child bearing capacity
* ABPI \< 0.7
* Serum albumin \< 2.0 g/dL
* Gangrene on any part of the foot with the study ulcer
* Presence of signs of clinically significant foot infection on Day 0
* Chronic renal failure with calculated GFR \<30 ml/min
* Surgical procedure (other than debridement) on the foot with the study ulcer in the 28 days prior to Day 0
* HbA1c 12% or more
* Current alcohol or drug abuse
* Participation in other studies in the preceding 28 days
* An ulcer on a foot affected by acute Charcot osteoarthropathy