cyrilzakka/clinical-trials huggingface dataset:
Soft Contacts Observation of Risk and Education (SCORE)

Specific Aims

1. Develop risk assessment scores for SCL wearers
2. Test the scoring algorithm in SCL wearers who present with adverse events
3. Explore targeted patient education to reduce risk behaviors associated with SCL wear.

This will be a multi-center, case-control prospective study. Subjects will be enrolled at five geographically diverse locations across North America. The intent is to enroll cases with new (untreated) red eyes and controls that are representative of the contact lens wearing population and test the new scoring algorithm on this population.

A total of 232 participants are expected to complete the study (116 case-control sets). Enrollment will be competitive. After consent, subjects will complete the Contact Lens Risk Survey (CLRS) online at www.claystudy.org. Data related to symptoms, medical history and anterior segment evaluation will be collected. Subjects will be treated as usual and customary by the investigator. No intervention of treatment in this study. Subjects will be asked to repeat the CLRS at one and six months post initial visit.

Initial factor analysis from the previous CLRS data were used to develop and test the CLRS algorithm. Five sub-scales were identified in the areas of contact lens care, contact lens dependence, hygiene, living arrangements and wellness. Assuming a 10% missing data rate, a total of 58 SCL wearers with "serious and significant" red eye events will allow for detection of 0.4 or larger effect size.

There are multiple steps to "compliant wear" of contact lenses and while many patients do many of the correct wear behaviors, it's not realistic for practitioners to re-educate all wearers on all of the steps necessary to successfully wear SCLs. The CLRS allows patients to quickly report their specific wear behaviors and then receive only the targeted information on which behaviors they are doing that puts them at higher risk. A previous CLAY study demonstrated good repeatability of the CLRS survey one week after initial fielding.

Eligibility Criteria:
Inclusion Criteria:

* CASES

  * Current SCL wear (as defined by having worn lenses in previous week) without restriction on lens material, design, indication, wearing schedule or lens power
  * 18 - 39 years of age
  * New (untreated) symptomatic red eye CONTROLS
  * Current SCL wear (as defined by having worn lenses in previous week) without restriction on lens material, design, indication, wearing schedule or lens power
  * 18 - 39 years of age and gender and age-matched (± 3 years) to Case
  * Have not had an eye care examination within the past three months

Exclusion Criteria:

* CASES

  * Faculty, staff or student at an optometry college or school
  * Family or household member of an eye care provider, ophthalmic technician, ophthalmology or optometry residents or optometry students
  * Pregnancy (by self-report)
  * Currently enrolled in another eye/vision clinical trial
  * Previous participant in a CLAY study
  * Wearing SCL in conjunction with gas permeable (GP) lenses (i.e., piggyback design, hybrid lens.) CONTROLS
  * Same exclusion criteria as cases
Kinesthetic Exercises and Sine Sound Waves in Cervical Spondylosis

The goal of this Randomized control trial is to determine the Effect of kinesthetic exercises and sound waves on pain, ROM, shoulder alignment and disability in cervical spondylosis. The main question it aims to answer is:

Weather sine sound and kinesthetic exercise are effective in management of pain, rom, alignment, and disability in patients that are suffering from cervical spondylosis

Cervical spondylosis is a progressive disease defined by degenerative changes affecting the vertebrae, intervertebral disks, facets, and associated ligaments. Symptoms of cervical spondylosis manifest as neck pain and neck stiffness and can be accompanied by radicular symptoms when there is compression of neural structures. The degenerative changes are intervertebral disc degeneration, osteophyte formation, and ligamentum flavum and facet hypertrophy. The sine sound waves approach aims to provide orthopaedic spinal treatment through focused vibroacoustic treatment (fVAT) and manage the biomechanical aspect of back pain. Vibroacoustic therapy has been indicated for patients with a range of musculoskeletal, neurological, and haemodynamic problems demonstrating positive changes in pain, spasticity, movement control, and specifically fatigue and anxiety in those with spinalcord or brain injuries. For neck pain syndromes, the kinesthetic rehabilitation exercises (i. e.,eye-follow exercises, head relocation exercises, eye-head coordination, and gaze stability exercises) are developed to improve or restore somatosensory and sensorimotor function by enhancing tactile afferents cues. Kinaesthetic exercises have an added advantage over the conventional exercise programs as it uses an unconscious component of proprioceptive signals for the automatic control of cervical muscle tone and posture.

The research include 3 intervention groups Group A will be give sine sound waves treatment 6 sessions 3 times a week followed by 6 sessions 2 times a week. Group B will be given kinesthetic exercise for 6 weeks. And group C will be given combination of both group A and group B treatments. Outcomes, encompassing pain levels, range of motion (ROM), and Neck Disability Index (NDI) scores, will be evaluated using the Numeric Pain Rating Scale, Goniometer, and Crom device. Data analysis will employ SPSS version 26. Data will be collected at baseline, immediately post-intervention, and at follow-up intervals. Statistical analyses will be conducted to assess and compare the effects of the interventions on the primary and secondary outcomes, thereby addressing the research question regarding their relative efficacy.

Eligibility Criteria:
Inclusion Criteria:

* neck pain
* age 45-60 years
* radiography showed degenerative changes

Exclusion Criteria:

* cervical myelopathy
* whiplash injury
* infection involving the c-spine
BIA Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy

This study was designed to compare the efficacy of BIA and physician adjustment to prevent intradialytic hypotension in patients with acute kidney injury who received renal replacement therapy. The investigators randomized 9 patients with acute kidney injury and volume overloaded who underwent acute hemodialysis for 45 sessions in Vajira hospital between October 2017 and February 2018. In physician adjust-group (control) estimate by physical examination and fluid balance record. Primary outcome was intradialytic hypotensive episode and secondary outcome was hemodialysis-related adverse events and other clinical outcome.

Background

Volume overload and intradialytic hypotension are significant complications with increasing mortality rate in hemodialysis patients. Bioelectrical Impedance Analysis (BIA) has been used to estimate the optimum weight in chronic hemodialysis patient to prevent intradialytic hypotension.Volume assessment in acute kidney injury is also of great importance , however, there are currently few methods to obtain an accurate assessment of hydration status in this scenario. This study was designed to compare the efficacy of BIA and physician adjustment to prevent intradialytic hypotension in patients with acute kidney injury who received renal replacement therapy.

Methods

The investigators randomized 9 patients with acute kidney injury and volume overloaded who underwent acute hemodialysis for 45 sessions in Vajira hospital between October 2017 and February 2018. Volume overload was defined by BIA with value more than\>0.4. In physician adjust-group (control) estimate by physical examination and fluid balance record. Primary outcome was intradialytic hypotensive episode and secondary outcome was hemodialysis-related adverse events and other clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute kidney injury with volume overload unresponsive to medication therapy =Required renal replacement therapy (RRT)

Exclusion Criteria:

Patients who were pregnant

* Advanced malignancy
* Kidney transplantation
* AKI from toxins
* Currently on pacemaker
* Had underlying chronic kidney disease
* Patients with severe cardiovascular disease such as congestive heart failure, valvular regurgition
Febuxostat Versus Allopurinol Control Trial in Subjects With Gout

The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.

This was a randomized, controlled, double-blind study of 52 weeks duration. Subjects receiving prior urate-lowering therapy underwent a 2-week washout period prior to randomization. Subjects were then randomized to one of three treatment groups: febuxostat 80 milligram (mg), febuxostat 120 mg, or allopurinol 300 mg. Naproxen (250 mg twice daily) or colchicine (0.6 mg once daily) was provided for prophylaxis of acute gout flares during the washout period and the first 8 weeks of double-blind treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout.
* Serum uric acid ≥ 8.0 milligrams per deciliter (mg/dL) at Baseline

Exclusion Criteria:

* Serum creatinine \>1.5 mg/dL
* Calculated creatinine clearance of \<50 milliliters per minutes (mL/min)
* Pregnancy or lactation;
* Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (\>325 mg) or other salicylates;
* Body Mass Index (BMI) \>50 kilogram per meter²(kg/m²);
* A history of xanthinuria, active liver disease, or hepatic dysfunction;
* A history of alcohol abuse or intake of 14 or more alcohol-containing drinks/week.
Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

Primary Objective:

* The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin.

Secondary Objectives:

* To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on:

  * Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test;
  * Percentage of participants reaching HbA1c \<7% or ≤6.5%;
  * 7-point Self-Monitored Plasma Glucose (SMPG) profile;
  * Body weight;
  * Insulin glargine dose
  * Fasting Plasma Glucose (FPG);
  * Percentage of participants requiring rescue therapy during the 24-week open label treatment period;
* To assess safety and tolerability of insulin glargine/lixisenatide FRC.

Approximately 27 weeks including a 24-week treatment period.

Eligibility Criteria:
Inclusion criteria:

* Participants with type 2 diabetes mellitus diagnosed for at least 1 year.
* Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening.

Exclusion criteria:

* Age \< legal age of adulthood (18 years).
* Screening HbA1c \<7% or \>10%.
* Screening FPG \>250 mg/dL (\>13.9 mmol/L).
* Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
* Type 1 diabetes mellitus.
* Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening.
* Use of insulin within the last 6 months.
* Previous use of insulin, except for episode(s) of short-term treatment (≤15 consecutive days) due to intercurrent illness.
* Amylase and/or lipase \>3 times the upper limit of the normal laboratory range (ULN) at screening.
* Calcitonin ≥20 pg/ml (5.9 pmol/l) at screening.
* Alanine Transferase (ALT) \>3 ULN at screening.
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes).
* Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure \>180 mmHg or \>110 mmHg, respectively.
* Within the last 6 months prior to screening: history of heart failure requiring hospitalization, myocardial infarction, or stroke. Planned coronary, carotid or peripheral artery revascularisation procedures.
* Body Mass Index (BMI) ≤20 or \>40 kg/m\^2.
* Any previous treatment with lixisenatide

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions

The objective of this study was to assess bioequivalence of a potential generic 1 mg granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet, Kytril, following a single 1 mg dose, under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to granisetron or any other comparable or similar product.
Nocipoint Therapy Versus Standard Physical Therapy Using Electrical Stimulation in Treating Pain From TMJ Disorder

The purpose of this study is to measure the effect of nocipoint therapy on patients with temporomandibular joint disorders (TMD) and compare it with the effect of standard electrical stimulation therapy.

The prevalence of temporomandibular disorders (TMD) is about 20% to 60% of dental patients. Most patients suffer from myofascial pain (MFP) subtype of TMD. Analgesics, local muscle injection or oral appliance are often used to treat TMD-related MFP. Patients are also referred to physical therapists frequently. Many physical therapy (PT) modalities and techniques are applied to these patients, including non-invasive transcutaneous electrical nerve stimulation (TENS) using TENS devices. However, the exact application of TENS devices, including the location of the stimulation, duration and intensity of stimulation, is largely decided by physical therapists. Nocipoint Therapy, a unique combination of precise location, duration and intensity of TENS has been found to substantially relieve general myofascial pain and recover the muscle function with lasting effect.

In preliminary observations of clinical applications, Nocipoint Therapy has been found to rapidly and substantially relieve TMD-related MFP within 2-3 sessions of the treatment.

This clinical study compares the effect of Nocipoint Therapy on TMD with that of standard Physical therapy (PT). TENS will be used in the control group both as a part of the standard of care (i.e., PT) and as placebo.

Eligibility Criteria:
Inclusion Criteria:

* 20-65 years old female or male
* Diagnosed as MFP subtype of TMD according to RDC/TMD
* Pain duration over 3 month
* Tender point in masseter
* Asymmetrical pain intensity
* Subsided symptoms of joint inflammation

Exclusion Criteria:

* Traumatic TMD from external impact force
* History of traumatic cervical injury
* Presence of systemic disease
* Fibromyalgia
* Co-interventions for cervical problems or TMD during study period
* Signs of psychosomatic illness
* Unwilling to be randomized
The Value of Novel Thrombus Markers in the Diagnosis and Treatment of Acute Pulmonary Embolism

In response to the high mortality rate of patients with acute pulmonary embolism (APE) and the fact that only a small proportion of deceased patients can receive correct diagnosis, this study will use a sensitive, non-invasive, and feasible new thrombus molecular marker (TAT/PIC/TM/t-PAIC) to detect and evaluate the activation of the coagulation and fibrinolysis systems and endothelial system damage in patients, in order to monitor the early diagnosis and treatment of APE, reduce mortality, and improve patient quality of life. Therefore, this study intends to include 200 newly diagnosed APE patients to evaluate the sensitivity and specificity of the single and combined application of novel thrombus molecular markers for APE diagnosis; Detect the biomarker results of patients at different time points before and after treatment, and evaluate their value in APE treatment monitoring; Track and follow up on patients after discharge to explore the prognostic value of biomarkers for APE.


Eligibility Criteria:
Inclusion Criteria:

* 1.Patients diagnosed with APE for the first time through CTPA in clinical practice and who have not received anticoagulant therapy in the past month; 2.Age ≥ 18 years old.

Exclusion Criteria:

* 1. Complicated with other thrombotic diseases, complicated with important organ damage such as heart, liver, kidney, and previous history of pulmonary embolism; 2. Malignant tumors; 3. Renal dialysis patients; 4. Antiphospholipid syndrome; 5. Immune system diseases; 6. Hematological diseases; 7. DIC caused by severe infection; 8. Patients judged by clinicians to be unfit for clinical practice.
EZ Blocker Versus Left Sided Double-lumen Tube

Lung isolation is used to achieve one lung ventilation to facilitate thoracic surgery. Two methods are commonly used, a double lumen tube (DLT) or a bronchial blocker introduced through a single lumen tube. However, both techniques have advantages and disadvantages. Briefly, the DLT can be positioned faster and remains firmly in place, but is sometimes difficult or even impossible to introduce. The DLT is larger than a conventional single lumen tube and the incidence of postoperative hoarseness and airway injuries is higher. Compared to the DLT, bronchial blocking devices are more difficult to position and need more frequent intraoperative repositioning. These disadvantages of the existing devices for lung isolation prompted further development of the bronchial blocker concept. The design of a new Y shaped bronchial blocker, the EZ- Blocker® (AnaesthetIQ BV, Rotterdam, The Netherlands) (EZB), combines the advantages of both lung isolation techniques. The aim of the study is to compare in a randomised, prospective way the ease of placement, the incidence of malpositioning and the quality of lung deflation of a left DLT and a EZB. Secondly, the incidence and severity of damage to laryngeal, tracheal and bronchial structures caused by the use of the DLT or the EZB is a target of the study.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1-3 patients
* Patients scheduled for surgery requiring a left sided DLT for single lung ventilation

Exclusion Criteria:

* Contraindications are lesions along the path of the left sided double lumen tube or the EZB
* Tracheal or mainstem bronchial stenosis
* Distorted carinal anatomy,
* Anticipated difficult intubation (Mallampatti score ≥ 3)
* History or presence of tracheostoma
* Patients who require absolute lung separation
* Patients who require sleeve resection of mainstem bronchus
Treatment of Tendon Injury Using Mesenchymal Stem Cells

Main purpose of this study is to evaluate efficacy and safety of allogenic adipose-derived mesenchymal stem cells(ALLO-ASC) in treatment of tendon injury. ALLO-ASC will be administrated to the patients with lateral epicondylitis by ultrasonographic guided injection.

Injection volume depends on the size of lesion on ultrasound examination. And all injection will be done under ultrasound guidance. First the investigators will administrate 1 million cells/ml (Group 1 for 6 participants). After monitoring the safety of injection for 2 weeks (the investigators will use WHO recommendations for grading of acute and subacute toxic effects), the investigators decide to increase the quantity as 10 million cells/ml (Group 2 for participants).

The investigators will compare the efficacy difference as quantity increase. For efficacy measurement, VAS/modified Mayo clinic performance index for elbow/lesion measurement by ultrasound will be used at 6 and 12 weeks after injections.

Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed as lateral epicondylitis (tennis elbow)
* recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
* symptom duration is over 6 months
* defect in common extensor tendon can be observed under ultrasound
* patient that can understand the clinical trials

Exclusion Criteria:

* patient that underwent other injection treatment within 6 weeks
* some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue)
* patient that enrolled other clinical trials within 30 days
* history of drug/alcohol addiction, habitual smoker
A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients

The purpose of this study is to determine whether a new cerebral oxygenation monitoring device is comparatively similar to the current approved devices.

Cerebral oxygenation monitoring is an innovative way to monitoring cardiac surgery patients intraoperatively to reduce the incidence of postoperative hypoxic side effects. There are a number of approved devices already in the market that have proved their efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. To be 18 years old or older
2. Scheduled for cardiac surgery
3. Treatment will include 72 hours or more of hospital stay
4. Understand enough about the risks and benefits of the study to be able to make an informed decision before agreeing to be in the study

Exclusion Criteria:

1. History of cerebrovascular disease
2. History of skin problems on forehead (skin rashes, acne, allergies, etc.)
3. History of craniofacial surgeries
4. Pregnancy