cyrilzakka/clinical-trials huggingface dataset:
Effect of Longitudinal Sleep Monitoring on Diagnosis and Treatment Decision in Patients with Suspected Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is a highly prevalent sleep-disordered breathing disease, caused by recurrent episodes of partial or complete collapse of the upper airway during sleep, resulting in intermittent hypoxia, fragmented sleep, fluctuations in blood pressure, and increased sympathetic nervous system activity. A single-night sleep study (i.e. respiratory polygraphy or polysomnography) is currently considered to be the gold standard for diagnosing OSA. However, recent studies suggest a significant intra-individual night-to-night variability of respiratory events, leading to the hypothesis that one single-night study might not reflect an accurate picture of the disease.

Part A: Patients with suspected obstructive sleep apnea, referred to our clinic, undergo the regular diagnostic procedure recommended by the current guidelines. In addition to the in-hospital single-night sleep study, these patients will perform 14 nights of pulse-oximetry at home. By computing and analysing sensitivity and specificity of every additional night, the investigator will answer the questions how many nights of sleep monitoring by home oximetry are necessary to diagnose OSA reliably, and how longitudinal sleep monitoring could reduce the number of false-negative and false- positive results compared to the in-hospital single-night study.

Part B: Based on the patients' data of part A, the investigator will develop a questionnaire and present anonymized cases to experts in the field of sleep medicine. Thereby, the investigator will evaluate if the additional information of repeated nocturnal pulse-oximetries changes the experts' decision making regarding diagnosis and treatment of OSA.

In a second step, the investigator will perform a classical Delphi study with a panel of experts in sleep medicine to establish consensus on repeated sleep studies and how they should be used for diagnosis and treatment in patients with suspected OSA.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Suspected obstructive sleep apnea
* ≥18 years old

Exclusion Criteria:

* Suspected or diagnosed sleeping-disordered breathing other than OSA
* Moribund or severe disease prohibiting protocol adherence especially COPD GOLD III-IV and heart failure NYHA III-IV
* Patients receiving oxygen therapy or home ventilation
* Continuous positive airway pressure treatment for OSA at baseline
* Physical or intellectual impairment precluding informed consent or protocol adherence
* Pregnant patients
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)

This is a controlled study designed to compare relapse-free survival and overall survival in patients receiving UFT with those in patients receiving surgery alone. Patients will be randomly assigned to surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 12 months after the start of treatment.Evaluations will be separately done for colon cancer and rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 75
* Performance status 0 , 1, or 2 (ECOG)
* Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3
* Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.2mg/dL
* Renal BUN ≤ 25mg/dL Creatinine ≤ 1.5mg/dL

Exclusion Criteria:

* Prior anticancer treatment
21% Hydrochloric Acid Based Versus 6.6 % Hydrochloric Based Micro Abrasive Kit in Management of Patients With Mild to Moderate Fluorosis

compare the clinical performance of different concentrations of hydrochloric acid based as micro abrasive kits in management of patients with mild to moderate fluorosis over 6month follow up .

microabrasion is a permanent cosmetic dentistry treatment indeed to preserve the health of all part of any defect in enamel.

Eligibility Criteria:
Inclusion Criteria:

Patients who wanted to change the appearance of their stained teeth Males or females. Patients with three or more stained incisors and canines Patients willing and able to attend periodic follow-up visits Patient concerning with oral health. Co-operative patients who show interest to participate in the study.

Exclusion Criteria:

Patients with known allergic or adverse reaction to the tested materials. Smoking habit Patients having Poor oral hygiene Patients with special health care needs or any systemic disease that may affect treatment Patients participating in other dental studies. Patients suffering from white spot lesion, hypoplasia, amelogenesis imperfecta, dentinogenesis imperfecta, or badly broken and missing teeth due to MIH.

Participants who had a history of dental bleaching.
Early Intervention for Children at Risk for Anxiety

The aim of this study was to develop and pilot a cognitive-behavioral therapy (CBT) parent-child intervention for 4-7-year-old children at risk for anxiety disorders. The 20-session intervention was first piloted openly in 9 children (between 3/10/98 and 1/1/2001). The intervention was then tested in 65 children in a randomized controlled trial versus a monitoring-only wait-list control condition. Children had to either have an anxiety disorder, behavioral inhibition, or be the offspring of a parent with an anxiety disorder who had elevated symptoms of anxiety. In practice all children but one had at least one anxiety disorder at baseline. Children were blocked on presence or absence of parental anxiety disorder and randomized to the intervention or to a no-intervention wait-list control group. The intervention consisted of 6 parent-only sessions, 8-13 child-parent sessions, and a final parent session. Post-trial assessments were conducted at six months, and at one-year follow-up. The hypotheses were that the children assigned to the intervention group would show significantly better improvement (measured via Clinician Global Impression-Anxiety Improvement scale and absence of anxiety disorders) than children assigned to the wait-list condition.


Eligibility Criteria:
Inclusion Criteria:

* The child is at risk for anxiety disorders, as indicated by at least one of the following:
* the child has behavioral inhibition (as determined by observed behavioral assessment);
* the child meets criteria for a DSM-IV or IIIR anxiety disorder (as determined by Kiddie-Schedule for Affective Disorders and Schizophrenia, Epidemiologic Version \[K-SADS-E\] with the mother); or
* the child has both a parent with lifetime history of anxiety disorder (as determined by direct Structured Clinical Interview for DSM-IV \[SCID-IV\] with both parents) and the child has anxious symptomatology, as indicated by Child Behavior Checklist \[CBCL\] scale scores (T-scores) on Anxious/Depressed or Withdrawn of 55 or higher.
* The child is between the ages of 4 and 7 years
* The child and parent(s) have a working command of English

Exclusion Criteria:

* Psychosis in parent or child
* Suicidality in parent or child
* Current alcohol or substance abuse in a parent
* Mental retardation or pervasive developmental disorder in parent or child
* Child in current psychiatric treatment
* Child judged too uncooperative or distractible to take part in intervention
* (In the controlled trial): Child judged clinically unable to wait six months for treatment. The following criteria are used in determining whether the child can wait for 6 months before receiving treatment:
* Suicidal Ideation
* Serious impairment in eating or sleeping habits
* Severe social isolation
* Severe impairment in school functioning or attendance
* Severe symptoms of obsessive-compulsive disorder (OCD)
* Clinical judgment based on the child's overall severity of symptoms and family functioning.
* All judgments of severity of symptoms/impairment are based on a clinician review of the Kiddie-SADS-E and a clinical evaluation with the family.
Posterior Lateral Fusion (PLF) With Dynesys

The primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System. Secondary purpose of this study is to assess outcomes with historical controls along a continuum of motion and anatomy sparing procedures.

This study will help the patient to the extent that it will allow the comparison of this unique treatment to the corpus of literature on radicular pathology, thus focusing a specific treatment for a specific pathology.

Eligibility Criteria:
Inclusion Criteria:

* Spondylolisthesis of less than Grade II at the index level (degenerative with intact pars)
* Will receive a decompression for lumbar stenosis
* Symptoms of leg and/or back pain
* One pathological level
* Between the ages of 20 and 80 at the time of surgery
* Non-responsive to non-surgical treatment for at least six months

Exclusion Criteria:

* Osteolytic spondylolisthesis
* Planned complete facetectomy
* Two or more pathological levels (and as enumerated int he Dynesys Spinal system instructions for use)
* Use in the cervical spine
* Active systemic or local infection
* Extreme obesity as defined by a Body Mass Index (BMI)over 40. BMI calculated using Appendix A, adapted from the National Heart, Lung, and Blood Institute, Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults.
* Pregnancy
* Mental illness
* Severe osteoporosis or osteopenia. The World Health Organization defines osteoporosis as BMD\<-2.5t. Professional discretion should be used and if bone quality is in question a DEXA scan is recommended.
* Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and polyethylene terephthalate
* Alcohol or drug abuse
* Patient unwilling or unable to follow postoperative instructions
* Soft tissue deficit not allowing sound closure
* Any medical or physical condition that would preclude the potential benefit of spinal surgery
* Inadequate pedicles of the lumbar or sacral vertebrae; congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of othe devices;
* Any medical or mental condition which would exclude the patient at high risk from surgery of the severity
Sinus Lift Using PTFE Titanium Reinforced Membrane

Various attempts have been implemented using different materials and techniques to augment the maxillary sinus floor enhancing autogenous bone formation to allow proper dental implant positioning. The aim of this study is to evaluate the sinus lift procedure using polytetrafluoroethylene (PTFE) titanium-reinforced membrane to maintain the space formed after Schneiderian membrane elevation followed by immediate implant placement.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders requiring implant placement in posterior maxilla
* Age range: 40-60 years.
* Good oral hygiene
* Healthy maxillary sinus free from pathology
* The minimum crestal bone height is (4-6) mm
* Patients who are willing and fully capable to comply with the study protocol.

Exclusion Criteria:

* Sinus infection
* Tumors or pathologic lesions in sinus
* Severe allergic rhinitis.
* Chronic topical steroid use.
* Radiation therapy.
* Psychologic / mental impairment
* Acute infection (periodontitis or mucosal infection
* Patients on radiotherapy or chemotherapy.
* Alcohol or drug abuse.
* Patient with systemic disorder (uncontrolled Diabetes mellitus, autoimmune diseases, bone diseases, etc.)
* Smokers
* Parafuctional habits
Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke

Annually 100,000 strokes occur, placing stroke as the largest cause of disability in the UK. 90% of strokes are preventable, leading to national focus on programmes including "The National Stroke Programme" to act on preventing, treating, and improving post-stroke care. Importantly, over 25% of ischaemic stroke sufferers have previously had a Transient Ischaemic Attack (TIA), which presents the biggest concern for TIA patients. There are no measures which reliably identify TIA patients most likely to suffer a stroke. Novel biomarkers for predicting stroke are key to addressing this problem. The PREDICT-EV study aims to screen 300 TIA patients and follow them over 12-months. The investigators will determine if a novel biomarker we've identified to increase thrombotic risk (endothelial derived extracellular vesicles) and the resulting increased prothrombin time is associated with patients at highest risk of stroke.


Eligibility Criteria:
The inclusion criteria for phase 1 (initial patient recruitment) will be:

1. Patients with or without diagnosis of TIA made by a physician working in stroke medicine, sufficiently so to start post-TIA care or so that no further investigation is thought necessary to confirm or refute the diagnosis.
2. TIA confirmed patient has been prescribed antiplatelet drugs or anticoagulants.
3. Patients must be aged \> 18 years.
4. Patients are taking an ordinary diet by mouth.

The inclusion criteria for phase 2 (patient representing with stroke) will be:

1. Radiological evidence, on CT and/or MR imaging of the brain of cerebral infarction, with or without secondary haemorrhage.
2. The underlying mechanism of cerebral infarction is embolic from a cardiac source (e.g. atrial fibrillation), atherothromboembolic (from aorta or other large vessels in the neck) or in-situ thrombosis. No further investigations are thought necessary to confirm or refute the diagnosis.
3. No further investigations are thought necessary to confirm or refute the diagnosis.
4. Patients must be aged \>18 years.
5. Patients must not be pregnant or breast feeding.
6. Patients are taking an ordinary diet by mouth. Exclusion Criteria

The Exclusion criteria for phase 1 (initial patient recruitment) will be:

1. Inability to give consent.
2. Inability to feed by mouth.
3. Short life expectancy.
4. Pregnancy or breastfeeding.
5. Symptoms are readily explained by medical problems not involving focal cerebral ischaemia.

The Exclusion criteria for phase 2 (patient representing with stroke) will be:

1. Patients who have not previously given consent for follow up blood sampling.
2. Patients who are unable to feed by mouth.
3. Patients in whom life expectancy is short.
4. Patient is pregnant or breast feeding.
Music in the Emergency Department (ED): Phase II

The investigators will conduct a prospective quasi-experimental design study of patients in the University of Florida Health Emergency Department. Live preferential music will be performed for patients in the emergency department on alternating days over 20 weeks, and subjects exposed to the music intervention will be matched to a cohort that present to the emergency department on days with no music to assess impact on patient and healthcare provider satisfaction, pain medication utilization, length of stay, and cost of care.

Every year, over 130 million patients access emergency care in the US. Emergency Departments are high stress environments and are one of the significant drivers of high costs in healthcare. The prevalence of anxiety experienced by patients in the emergency department (ED) is abundant and substantial. Anxiety negatively affects the patient, the ED healthcare environment, and ED healthcare staff. Additionally, anxiety routinely results in the administration of medication that would be otherwise unnecessary, and contributes to the overall cost of healthcare and the stress of clinicians, particularly nursing staff. The University of Florida (UF) Department of Emergency Medicine, in partnership with the UF Center for Arts in Medicine, has recently completed phase one, and is proposing phase two, of a three-phase study to assess the impact of live preferential music on emergency department operations, including pain medication utilization and cost of care. The investigators propose to expand on the phase one pilot study to conduct a full randomized controlled study utilizing a group of highly talented musicians to provide live preferential music in our ED and level one trauma center setting. The project, the first systematic investigation of its kind, seeks to demonstrate that live preferential music in an emergency and trauma care setting can positively impact quality and cost of care.

Eligibility Criteria:
Inclusion Criteria:

* Language: english
* Cognitive skill/education: grade 2 reading level or above

Exclusion Criteria:

* Language: Non-english speaking
* Age: Less than 18
* Cognitive skill/education: lower than grade 2 reading level
Carpal Tunnel Syndrome in Patients With Psoriatic Arthritis; Ultrasonography and Magnetic Resonance Imaging Findings

This study aimed to investigate relationship between CTS diagnosis with electrodiagnostic studies and median nerve's cross-sectional area measered by US and MRI in PsA patients.

Carpal tunnel syndrome (CTS) is a type of entrapment neuropathy, caused by compression of the median nerve in the carpal tunnel at the wrist1. It accounts for about 90% of all entrapment neuropathies. But there is no gold standard technique for diagnosing CTS. Electrodiagnostic studies (EDS) are generally used in differential diagnosis because the symptoms may be difficult to interpret. Unfortunetely EDS has some limitations. The factors can limit EDS are that it is not comfortable for patients and physicians, may require interventional procedures, need patient cooperation, provide limited information on the etiology of CTS, time consuming, and can not be used in some patient groups such as patients with dermatological contraindications. Recent years, magnetic resonance imaging (MRI) and ultrasonography (US) have facilitated the diagnosis of CTS. The median nerve cross-sectional area (CSA) measured by US or MRI has been found to be associated with CTS. However, there are studies with conflicting results regarding the median nerve CSA in patients with rheumatic diseases. Psoriatic arthritis (PsA), a kind of rheumatic disease, occurs in up to 30% of people with psoriasis and can have serious debilitating effects on the peripheral joints, spine, tendon insertions, and fingers. To our knowlage, any study didn't assess MRI measurements of median nerve CSA in PsA patients. In this study we aimed to assess CTS's US and MRI findings in patients with PsA and compare them healty controls.

Eligibility Criteria:
Inclusion Criteria:

* PsA patients according to the CASPAR criteria who consecutively applied to the FTR outpatient clinic for PsA follow-up and healthy volunteers who applied to the FTR outpatient clinic enrolled in the study.

Exclusion Criteria:

* Patients were excluded from the study if they had history of conditions associated with an increased incidence of CTS except PsA (diabetes mellitus, pregnancy, hypothyroidism, renal failure or other severe systemic diseases); history or clinical/electrophyscologic finding of radiculopathy, plexopathy, polyneuropathy or any nervous system diseases; history of fractures, severe trauma or surgical interventions involving the wrist; bifid median nerve on wrist imaging and under the age of 18, over the age of 65. There was no history of rheumatic disease in the healthy volunteer group.
An Effectiveness and Safety 6 Months Study of 3 Injections One Week Apart of SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis

Multicentre, independent assessment study on SYNOLIS VA 40/80 over a period of 24 weeks


Eligibility Criteria:
Inclusion Criteria:

* Patient between 35 and 75 years old
* Patients with knee osteoarthritis. The diagnosis is based on the following American College of Rheumatology (ACR) classification:

  * Knee pain
  * Positive radiography (presence of osteophytes)
  * Morning stiffness \< 30 min and/or crepitus while walking
* Symptoms related to knee osteoarthritis for at least 6 months
* Treatment failure (i.e. ineffective response) with analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids
* Kellgren-Lawrence radiographic stage: I - III (pre-inclusion radiography)
* VAS pain index score ≥ 40 mm (VAS 0-100 mm) on the knee to be treated
* Contralateral knee pain \< 10 mm (VAS) compared to treated knee
* Patient signed inform consent form

Exclusion Criteria:

* Inability to understand the study or language used to be informed/sign the consent
* Participation in another clinical trial within 4 weeks prior to the start of the trial, and commitment to non-participation within 4 weeks following the end of the trial
* Intraarticular injection of hyaluronic acid in target knee within the 6 months prior to inclusion
* Patient who has received an intra-articular (IA) or intra-muscular (IM) steroid injection within the 3 months prior to inclusion or has taken oral corticosteroids within the month prior to inclusion
* Joint, bone, ligament, or any local or loco-regional surgery of the leg involved, arthroscopic operation on the target knee within the 3 months prior to inclusion
* Any recent trauma to the leg involved, including a sprain, dislocation within the 3 months prior to inclusion
* Rheumatoid arthritis, joint condition or any other inflammation and arthritis
* Lupus
* Dermatological disorder or any epidermal conditions that prevent an intraarticular injection
* Visible remarkable joint effusion of the target knee during physical examination evidenced by a protuberance or positive ballottement of the patella
* Evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments, horizontal meniscal lesion tear (FLAP) in the target knee
* Osteonecrosis (1 or both knees)
* Daily dosage \> 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment (antithrombotic). If dose \< 101 mg, must be maintained during the study
* Known intolerance/hypersensitivity/allergy to any of the components in either product, SYNOLIS VA
* Fibromyalgia
* Patient of childbearing potential, pregnant or breast-feeding known at inclusion or in the planning phase during the study unless willing to use contraceptives through the whole duration of the study
* Excessive and repeated consumption of alcohol or illicit substances
* Any medical condition that may interfere with the proper conduct of the study (including any surgery or hospitalisation)