cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Arginin and Potassium Nitrate Dentifrices in Dentin Hypersensitivity Therapy

Introduction: Dentin hypersensitivity (DH) could be defined as a brief and sharp pain in response to thermical, chemical, tactile and osmotic stimuli, which cannot be attributed to any dental condition or pathology. Multiple therapies for the treatment of DH have been studied, including equivocal evidence about the efficacy of potassium nitrate salts and recent investigations a promising new 8% Arginin dentifrice.

Aim: The aim of this study is to compare the clinical effectiveness of 8% arginine/1450ppm sodium monofluorophosphate (D1) and 5% potassium nitrate/2500ppm sodium fluoride (D2) dentifrices in the treatment of dentin hypersensitivity.

Methods: Parallel-design, double-masked, randomized controlled clinical trial. Fifty healthy volunteers aged 18 to 70 years who attend at the Faculty of Dentistry , University of Chile, with DH and a visual analog scale (VAS) score ≥4 at least in two anterior and/or premolar teeth, will be selected and randomized into two treatment groups: T1 (n=25): 8% arginine/1450 ppm sodium monofluorophosphate dentifrice (D1); and T2 (n=25): 5% potassium nitrate/2500 ppm sodium fluoride dentifrice (D2). Environmental, dietary and oral hygiene habits will be recorded in a clinical chart, while O´Leary plaque index and dentin hypersensitivity (DH) measurements will be clinically assessed, at baseline, 4 and 8 weeks. DH will be evaluated through the mean VAS value in response to evaporative and thermal stimuli at baseline, 4 and 8 week follow-up. The data will be analysed through Stata® V11 program.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years
* Dentin sensitivity in at least 2 teeth (incisors, cuspids and/or bicuspids) with a VAS score ≥4
* Good general health

Exclusion Criteria:

* Defective or extensive restorations, deep dental caries, pulpitis, chipped teeth,
* Bridgework, dentures or crowned teeth that could interfere with the evaluation of hypersensitivity
* Pregnancy or lactation
* Ongoing treatment with anti-inflammatory or sedative drugs
* Systemic conditions that are etiologic or predisposing to dentine hypersensitivity, like chronic acid regurgitation
* Ongoing periodontal therapy or periodontal surgery in the preceding 3 months
* Allergic responses to the dentifrices
* Hypersensitivity treatment in the preceding 3 months
Gestational Age Specific Thyroid Function Reference Range

It has been well accepted that maternal thyroid dysfunction has adverse affects on both mothers and fetuses. However, the dramatical changes during pregnancy make the interpretation of thyroid function test (TFT, i.e. free triiodothyronine \[FT3\], free thyroxine \[FT4\] and thyrotropin \[TSH\]) very difficult. Previous studies have shown that the level of thyroid hormones differs from non-pregnant population and varies from gestational ages. Moreover, studies have shown the agreement among different instrument platforms was quite low. This study is aimed to determine gestational age specific TFT reference ranges of the local pregnant population for all available platforms currently used under Hospital Authority and Department of Health.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women receiving pregnancy and postnatal care in the Department of Obstetrics \& Gynaecology, Prince of Wales Hospital, Hong Kong

Exclusion Criteria:

* 1. Previous history of thyroid dysfunction (hypothyroidism or hyperthyroidism);
* 2. Autoimmune disease, particularly those receiving corticosteroid or immunosuppressant: e.g. systemic lupus erythematosus;
* 3. Disease associated with thyroid dysfunction: e.g. molar pregnancy
The Outcome of Sports Vision Training on Collegiate Softball Players

To investigate the outcomes of sports vision enhancement training on softball players, specifically the visual skills and visual function. This will help to develop and hone best practice methods for future research as well as training protocols for athletes.

After informed consent is given by each participant, they will go through a pre-training evaluation at the Sports Vision Clinic at University Incarnate Word. The evaluation will include a Senaptec Sensory station evaluation of 10 skills, 1) visual acuity 2) contrast sensitivity 3) depth perception 4) near far quickness 5) perception span 6) multiple object tracking 7) reaction time 8) target capture 9) eye hand coordination 10) go/No go. Other skills will be evaluated and re-measured using different types of equipment for better reliability. 11) visual acuity using Rabin Super vision 12) contrast sensitivity using Pelli-Robson and Rabin Super vision 13) accommodative facility 14) reaction time on Dynavision 15) depth perception on the Howard-Dolman, Randot and Automated Vision Tester 16) vergence ranges 17) accommodative amplitude. At the first evaluation each participant will also be asked to complete an entering questionnaire, and at the last evaluation each participate will be asked to complete an exit questionnaire.

The above-mentioned evaluation of 17 items, will be given to each participant pre-training protocol, post-training protocol and once more after a washout period of 5 weeks.

The training protocol will consist of once weekly training sessions 45 minutes in duration. Every participant will receive the same training protocol the only variation will be level of advancement, some athletes will advance at different rates onto more complex levels of each activity. This is to allow continued improvement of the athletes and maintain motivation. Each training session will consist of the following activities 1) Brock string to improve vergence accuracy and depth perception; 2) Senaptec Strobe glasses while performing toss and catch, to improve concentration and visualization; 3) Eye Metrix double eye speed scanning, activities using a number board, aimed at collecting visual information quickly and accurately; 4) Senaptec Synchrony activities to improve anticipation and timing; 5) Senaptec Sensory Station Near Far, focus and concentration activities to improve eye accommodation accuracy; 6) Dynavision activities to improve reaction time, eye-hand coordination, and central-peripheral processing speeds; 7) Sports Vision Trainer Go/No go activities to improve low contrast and go/ no go decision making; 8) Senaptec Sensory Station spatial memory activities to improve memory span and peripheral awareness. Each activity will be performed twice.

Eligibility Criteria:
Inclusion Criteria:

* Member of the University women's softball team
* Pregnancy allowable
* Good academic standing

Exclusion Criteria:

* History of epilepsy
* History of seizures
PENS or TENS for Pain in Pancreatic Cancer

This study evaluates the effect of percutaneous electrical nerve stimulation (PENS) and transcutaneous nerve stimulation (TENS) for pain relieving in patients with pancreatic cancer. Patients will randomly allocated into PENS group, Tens group and control group.

PENS and TENS have been reported with analgesic effect in patients with pain, including cancer pain, lower back pain, neck pain, stomachache and so on.

Effect and mechanism of PENS on pain relieving has been widely researched. With additional electrical stimulation in certain frequency and intensity to conventional acupuncture, pain controlling effect has been largely enhanced. However, invasive operation limits its application and acceptability, especially on pancreatic cancer.

TENS is an advanced technique generated from PENS, which is much more welcome for its noninvasive character. Further more, its analgesic effect on cancer pain has been proved by several multi-central, randomized, clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic cancer with pain;
* Haven't underwent neurolytic celiac plexus block in the past 1 month;
* With anticipatory survival of more than 3 months.

Exclusion Criteria:

* Metastatic pancreatic cancer;
* Can not tolerate 30 min of lieing in prostrate or side position;
* PS\>3;
* Who has been recruited in other clinical trial for pain releiving;
* Who underwent radiotherapy or local radiactive seeds implantation for pain releiving in the past month;
* Imaging diagnosed with encephalic tumor or metastasis;
* Who with cardiac pacemaker or metal stand;
CERTAS Programmable Valve Registry

Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.

The CODMAN CERTAS Plus Programmable Valve is a single use implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.

The clinical investigation specifically aims to collect data on the performance measures outlined below. Data will be collected per standard of care, given the nature of the clinical investigation to capture real world data (registry); timing, frequency, and methodology of assessing the performance outcomes may therefore differ per center, subject, and/or visit.

1) Improvement of the following symptoms related to hydrocephalus:

* Gait disturbances;
* Spatial impairment;
* Cognitive abilities;
* Urinary incontinence;
* Pain caused by headaches;
* Visual acuity.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (18-80 years old at time of enrollment) undergoing implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.
2. Patients willing and able to understand and sign informed consent.

Exclusion Criteria:

N/A
Tricaprilin Phase 3 ALTER-AD (Alternative-Alzheimer Disease) Study

The purpose of this study is to evaluate the effects of tricaprilin (20 g twice a day) on cognition, activities of daily living, resource utilisation, safety and tolerability, in subjects with mild to moderately severe probable AD.

This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre design in up to 535 participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Mini Mental State Exam (MMSE) score between 14 to 24
* Meets diagnostic clinical criteria of probable Alzheimer's dementia according to the NIA-AA criteria
* Magnetic resonance imaging (MRI) compatible with a diagnosis of probable AD according to central MRI reader.
* Participants taking the following cholinesterase inhibitors: donepezil, galantamine, or rivastigmine; and/or memantine

Key Exclusion Criteria:

* Current use or use within 3 months of Visit 3 (Baseline), of medium chain triglyceride -containing products.
* Completed less than 6 years of formal education.
* Has any medical or neurological condition, other than AD, that could explain the subject's dementia (e.g., structural abnormality, traumatic brain injury, stroke, epilepsy, Parkinson's disease, alcohol-related dementia)
* Has a modified Hachinski Ischaemia score \> 4
A Trial of Degarelix in Patients With Prostate Cancer

A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Has a histological confirmed prostate cancer Gleason graded).
* Has a screening testosterone above 2.2 ng/mL.
* Rising prostate-specific antigen (PSA).
* Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.
* Has a life expectancy of at least one year.

Exclusion Criteria:

* Current or previous hormone therapy.
* Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.
* Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
* Has a heart insufficiency.
* Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years.
* Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
* Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.
* Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
The Effect of Neurorehabilitation Therapy on Postural Control, Mobility and Quality of Life in Multiple Sclerosis Patients

Abstract Introduction: Postural control disorders are the most common motor disorder associated with multiple sclerosis.

Objective: The aim of this study is to demonstrate the potential for improvement of postural control, motion performance and quality of life in patients with multiple sclerosis who are performing a special neurorevolutionary balancing program.

Intervention: The treated group (n = 15) performed five times a week for the treatment we defined. (60 minutes per day). The experimental group performed movements using the Xbox 360 and Kinect consoles. The study team participated in 25 sessions, five times a week. The duration of treatment was 5 weeks.The MStp group (n=14) participated in a 5-week physiotherapy course. The general treatment consisted of strengthening, stretching and walking correction. During the 5-week period, 25 patients attended training. One treatment takes 60 minutes. Sensory Organisation Test / Body Sway at the end of the baseline and treatment protocol is used to evaluate each patient. The quality of life mapping was measured by subjective tests (EQ-5D-5L, ADL). To assess the depressive state, a Beck depression questionnaire was used. Balance and motion performance were used by the Berg Balance Test and 6Minutes Walk Test. The results were compared with the control group results (n = 14) and showed improvement in overall balance and motion performance.


Eligibility Criteria:
Inclusion Criteria:

* Multiple Sclerosis
* instability problem

Exclusion Criteria:

* Severe heart problems, severe demeanor, alcoholism, drug problems
Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer

The purpose of this study is to evaluate the role of routine Staging Laparoscopy in patients with potentially resectable pancreatobiliary cancer.

To evaluate the role of routine staging laparoscopy in patients with potentially resectable pancreatobiliary cancer. All analyses are performed using SAS version 9.1.3 for Windows (SAS institute, Cary, NC). Clinical and pathological variables will be analyzed using the χ2 test (or Fisher's exact test) and the Student's t test, depending on the normality of the distribution. P-values of \< 0.05 are considering statistically significant.

Eligibility Criteria:
Inclusion Criteria:

1. Resectable pancreatobiliary cancer confirmed by radiologic studies (CT scan, MRI, PET-CT)
2. No evidence of distant metastasis
3. aged 15-80 year old
4. performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
5. adequate organ functions defined as indicated below

   1. WBC 3000 \~ 12 000/mm3
   2. \> Hb 8.0 g/dl
   3. \> Plt 100 000/mm3
   4. \< Cr 1.2 mg/dl
   5. \> Ccr 60 ml/min/body

Exclusion Criteria:

1. cystic neoplasm, neuroendocrine tumors
2. pregnant or breast-feeding women
3. previous upper abdominal surgery except laparoscopic cholecystectomy 4.Serious illness in medical condition

   1. unstable angina or myocardial infarction within 6 months of the trial
   2. unstable hypertension
   3. congestive heart failure
   4. severe respiratory disease requiring continuous oxygen therapy
   5. liver failure
   6. systemic administration of corticosteroids
   7. severe mental disorder
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma

Our research of the biology of upper gastrointestinal cancers involves the study of tissue samples and cells from biopsies of persons with gastric or esophageal cancer or blood samples from upper gastrointestinal cancer patients and persons at high inherited risk for these cancers. We hope to learn the role genes and proteins play in the development of gastric and esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Over 18
2. Diagnosed with gastric or esophageal cancer OR at an increased hereditary risk for upper GI cancer

Exclusion Criteria:

1. Under 18
2. No family or personal history of gastric or esophageal cancer
Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Atherosclerotic Plaques in Clinical Use

The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical use

Atherosclerotic plaques indicate the occurrence of ischemia events and how to deal with it is a difficult task for clinical physicians. Grape seed proanthocyanidin extrat (GSPE) has been reported to exert an antiatherogenic effect by inducing regression of atherosclerotic plaques in animal experimental studies. In this study, the antiatherogenic effect of GSPE has been investigated in clinical use.

Eligibility Criteria:
Inclusion Criteria:

* (1) carotid ultrasound examination: presence of carotid plaque or abnormal CIMT of between 0.9 and 1.2mm; (2) lipid profile: LDL≦3.12mmol/L, TC≦5.2mmol/L; (3) no lipid-lowering treatment within the past 6 months.

Exclusion Criteria:

* severe cardiomyopathy, acute coronary syndrome, hepatic dysfunction, end-stage renal failure (serum creatinine ≥117mmol/L), prior carotid endarterectomy, and/or patients who did not agree to participate in the present study.
A Study of Long-acting Injectable Risperidone in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder

The purpose of this study is to document the long-term safety and tolerability of risperidone, formulated as a long-acting injectable, in the treatment of patients with schizophrenia or schizoaffective disorder; in addition, to evaluate the long-term effectiveness of long-acting risperidone and its effect on quality of life

Although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen. Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. This safety study is an extension of a randomized, double-blind, multicenter, parallel group study that investigates effectiveness and safety of risperidone injected intramuscularly in patients with schizophrenia or schizoaffective disorder. The present open-label study evaluates 3 different doses of a formulation of risperidone injected into the muscle at 2 week intervals for at least 1 year in patients with these conditions. Assessments of effectiveness include the Clinical Global Impression (CGI) overall severity of illness scale. Quality of life will be assessed by the SF-36 Health Survey. Safety evaluations include incidence of adverse events, physical examinations, and evaluations of the injection site, clinical laboratory tests, electrocardiograms (ECGs), and Extrapyramidal Symptom Rating Scale (ESRS), a scale assessing muscle tone, gain, and abnormal movements. Injections every 2 weeks for at least 1 year, beginning at 25milligrams\[mg\] and increasing to 50mg or 75mg (maximum dose). Dosages may be increased or decreased at investigator's discretion. During the first 3 weeks, risperidone tablets (2mg) once daily to supplement injectable risperidone.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have completed the double-blind study (RIS-USA-121) or withdrawn from that study for safety reasons or due to worsening of condition as determined by results from the CGI
* diagnosis of schizophrenia or schizoaffective disorder according to criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DMS IV)
* otherwise healthy on the basis of physical examination, medical history, electrocardiogram, blood biochemistry and hematology tests, and urinalysis.

Exclusion Criteria:

* Known intolerance, sensitivity, serious adverse events, or unresponsiveness to risperidone
* diagnosis of DMS IV Axis I condition other than schizophrenia or schizoaffective disorder
* diagnosis of substance abuse or dependence
* use of psychostimulants or an antipsychotic medication other than risperidone
* known disease of the central nervous system (stroke, Parkinson's Disease, Huntington's Disease, Alzheimer's Disease, cancer)
* pregnant or nursing females, or those lacking adequate contraception.
ESWT in Lateral Epicondylitis: Clinical,Ultrasonographic Evaluation

This study aimed to check and compare how well shock wave therapy works for tennis elbow, both in terms of symptoms and what we can see on ultrasound.

42 patients with tennis elbow were split into two groups by chance: one group received shock wave therapy (ESWT), while the other received a fake treatment (Sham-ESWT) for comparison. Both groups underwent wrist exercises, splint usage, and ice application. Grip strength, pain levels, and how well they could move their wrist (functionality) were measured before, after, and one month post-treatment using tests. Additionally, the thickness of a common extensor tendon (CET) was evaluated using ultrasound. The patient, the doctor checking the patient, and the doctor doing the ultrasound didn't know which group the patient was in.

Eligibility Criteria:
Inclusion Criteria:

* experiencing pain and tenderness in the lateral epicondyle while extending their wrist and fingers against resistance for at least 3 months

Exclusion Criteria:

* Patients who are pregnant or have a coagulation disorder, cervical radiculopathy, peripheral neuropathy, peripheral vasculopathy in the upper extremity, complex regional pain syndrome, local infections, systemic inflammatory disease, fibromyalgia syndrome, arthritis (including rheumatoid arthritis, spondylarthritis, and crystal-induced arthropathies), malignancy, or those who have been treated with corticosteroids, PRP, or autologous blood injection, as well as those who have received physical therapy agents, undergone upper-extremity surgical interventions, or have a history of direct trauma to the elbow or a history of fracture,
Displaced Proximal Humeral Fractures: Delta Prothesis or Philos Plate?

To investigate the assumption that reversed shoulder prosthetic replacement will give a better functional outcome compared to open reduction and internal fixation with an angular stable plate in displaced proximal humeral fractures. Short name: The DelPhi trial.

Reversed total shoulder artroplasty (RTSA) equals Delta Xtend reversed total shoulder prosthesis.

Angular stable plate means Proximal humerus plate (Philos)

Eligibility Criteria:
Inclusion Criteria:

Patient admitted in hospital with a displaced three- or four part proximal humerus fracture of OTA / AO group 11-B2 or 11-C2 (displaced fracture of extra-articular or articular, bifocal type). The subgroups -.1, -.2 and -.3 will be included for both B2 and C2 groups, provided severe displacement: This is defined as a mal-position of at least 45º of angular deviation in valgus or 30º in varus in true frontal projection, regardless of whether the fracture is impacted or not, or less than 50% contact between humeral head and the metaphyseal part of the shaft. The greater or lesser tubercle displaced at least 10 mm.

Exclusion Criteria:

Patient younger than 65 years or older than 85 years, previous history of injury or illness of the injured shoulder, injuries of other parts of the humerus or the contra-lateral upper extremity, alcohol- or drug abuse, dementia, neurological diseases, or severe cardiovascular or lung diseases that would contraindicate surgery. Patients have to understand the Norwegian language and be compliant to rehabilitation and follow-ups.