cyrilzakka/clinical-trials huggingface dataset:
CBCT Segmentation in Volumetric Measurements of MS Using Different Soft Wares: A Validity and Reliability Study

Cone Beam Computed Tomography (CBCT) has been used to assess the volume of the maxillary sinus using the manual and semi-automatic segmentation. The majority of researches stressed on the reduced accuracy of the automatic segmentation when compared to the real volume. Regarding the semi-automatic segmentation, there are researches assessed the volumetric measurement of the maxillary sinus and they reported that there is no significant difference between semi- automatic and the manual segmentation in CT.

Automatic segmentation is believed to be less time consuming and more accurate in assessment of structures with regular border but fairly assessed the structures with irregular border like paranasal sinuses. The semi-automatic software is efficient and accurate as manual tracing with significant reduction in inter-observer variability and time . On the other hand, all neighboring contacting voxels located within a defined range (threshold) of similar HU values of different adjacent tissues may be measured so over calculation or under calculation could be suspected

Eligibility Criteria:
Inclusion Criteria:

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Inclusion Criteria of participants of the In vitro part of the study:

* Skulls with intact walls of maxillary sinus.
* Skulls with dentulous or edentulous jaws.

Exclusion criteria of participants:

* Skulls with missing parts of the maxilla that could be caused from traumatic injuries, diseases and space occupying lesions of maxilla.
* Skulls with severe mutilation caused by environmental decay.

Inclusion Criteria of participants of the In vivo part of the study:

* Patients without any pathosis affects maxillary sinus.
* Patients with dentulous or edentulous jaws.

Exclusion criteria of participants:

* Patients with traumatic injuries, diseases and space occupying lesions of maxilla.
* Patients with sinus lifting or surgeries.
* Patients with mucosal thickening more than 3mm
Efficacy of BGG492 in Individuals With Refractory Partial Seizures Undergoing Inpatient Evaluation for Epilepsy Surgery

This study will asses the safety and efficacy of BGG492 in reducing the seizure rate in therapy-refractory partial seizures.


Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of partial seizures (with or without secondary generalization) and undergoing an evaluation for epilepsy surgery, based on the classification of the International League Against Epilepsy (ILAE), as modified in 1981.
2. Absence of evolving space-occupying lesions or progressive neurological diseases.
3. Have normal vital signs (systolic and diastolic blood pressure and pulse rate)
4. All female subjects must have negative pregnancy test results
5. Subjects must weigh at least 50 kg to participate in this study and must have a body mass index (BMI) within the range of 18 to 35.

Exclusion Criteria:

1. A history of frequent and/or severe status epilepticus (i.e. requiring intensive care unit treatment).
2. Current treatment with phenobarbital, primidone or zonisamide (these drugs would have to be completely washed out before study start)
3. Having discontinued chronic benzodiazepine and barbiturate therapy within 30 days prior to the study start
4. Having electrodes implanted in the brain.
5. Having evidence on physical examination, or a history of any medically significant thyroid, cardiac, respiratory, hepatic, gastrointestinal, renal, hematologic, oncologic, psychiatric or progressive neurological disorder, requiring current medical intervention/therapy likely to have a significant impact on the outcome of this study.
6. With any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs, e.g. GI surgery and/or pancreatic or liver disease
7. Having a significant illness other than epilepsy within two (2) weeks prior to initial dosing.
8. Having recent (within the last three (3) years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc).

Other protocol-defined inclusion/exclusion criteria may apply
A Post Marketing Surveillance Study of INVOSSA K Inj.

This study is post-marketing surveillance of Invossa K injection in patients with osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients over 19 years
2. Patients who diagnosed with osteoarthritis will plan to INVOSSA K Inj. injection and suitable for following criteria :

   - Moderate knee osteoarthritis (Kellgren \& Lawrence grade 3) with persistent symptoms (pain, etc.) in spite of conservative therapy (medication, physical therapy, etc.) for more than 3 months
3. Patients (or substitute) who is provided all information regarding participation of this PMS signed the informed consent form

Exclusion Criteria:

1. Pregnant or breastfeeding female
2. Patients who have administered corticosteroid before INVOSSA K Inj. injection within the past 30 days
3. Patients who have severe disease such as heart, liver, kidney disease or other severe complications
4. Patients who rheumatoid arthritis, gouty arthritis, autoimmune disease associated arthritis except for osteoarthritis
5. Patients with a medical history of allergic diseases or patients with a medical history of anaphylactic reactions (including patients with a history of hypersensitivity reactions to the components of this drug, including dimethylsulfoxide (DMSO), mannitol, dextran 40 or bovine proteins)
6. Patients who have been treated with injections to the target knee within the past three months or patients with a past history of surgery, including arthroscope, within the past six months
7. Patients currently with leukemia or malignant tumors such as osteochondroma, chondroblastoma, cartilaginous mucinous fibrous tumor, chondroma and chondrosarcoma, which may be exacerbated by administration of INVOSSA-K inj. or patients with a history thereof
8. Patients with Kellgran \& Lawrence grade 4 osteoarthritis
Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?"

The histology of the placenta of newborn infants with perinatal asphyxia and hypoxic-ischaemic encephalopathy is analysed. There will be an evaluation if placenta could be a biomarker for neurodevelopmental outcome at 18-24 months of age.


Eligibility Criteria:
Inclusion Criteria:all newborn infants with APGAR \<5 at 10minutes, pH\<7.0, lactate \>12mmol/L, base excess \>16, resuscitation \>10min after birth, gestational age \>35 weeks and an encephalopathy -

Exclusion Criteria:

-
Digital Knee Osteoarthritis Mindset Intervention

The aim of our clinical trial is to test if an online mindset intervention improves mindsets and physical activity levels more than an education intervention in individuals with knee osteoarthritis.

Osteoarthritis affects 7% of the global population and is a leading cause of disability globally. Physical activity improves health outcomes, weight management, and knee function for people with knee osteoarthritis and should be considered first-line treatment. Yet, physical activity levels in this population are low compared to those without knee osteoarthritis.

Existing knowledge: Emerging research has highlighted the powerful influence of mindsets about exercise on engagement in physical activity. Mindsets are core assumptions about a domain or category that orient individuals to a particular set of attributions, expectations, and goals (a "meaning system"). In individuals with knee osteoarthritis, mindsets about the appeal of physical activity relate to future physical activity levels and one's chosen symptom management strategy, and mindsets about osteoarthritis relate to knee symptoms.

The investigators developed a digital mindset intervention to improve mindsets about exercise and osteoarthritis in individuals with knee osteoarthritis. The investigators piloted the intervention on 21 individuals with knee osteoarthritis throughout the United States. Participants improved in exercise and osteoarthritis mindsets. However, this was a small sample size, a control group was not used, and it was cross-sectional, thus, not able to evaluate changes in physical activity and osteoarthritis symptoms.

Need for a trial: A digital, low-cost, and, thus, scalable intervention to improve mindsets about osteoarthritis and exercise may improve pain and function and physical activity levels for the millions of individuals affected with knee osteoarthritis. A large randomized trial is therefore needed to evaluate if our mindset intervention leads to improvements in physical activity levels and osteoarthritis symptoms and, further, if these changes are due to more adaptive mindsets about exercise and osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Over 45 years of age
* Self-reported doctor's diagnosis of knee osteoarthritis OR meets the National Institute for - - Health and Care Excellence osteoarthritis clinical criteria (activity-related knee pain and no knee morning stiffness lasting ≥ 30 minutes)
* Knee pain for at least 3 months
* Ability to walk unaided
* Can read and write in English
* Consistent internet access
* Willingness and ability to comply with the study requirements

Exclusion criteria:

* Past total knee arthroplasty or scheduled surgical procedure on any back or lower limb with osteoarthritis within the next 12 months
* Recent serious injury (within the past 2 months) on the knee(s) with osteoarthritis
* Any condition making it unsafe to participate in physical activity
* Intra-articular therapy within the past 6 months (e.g. injections such as corticosteroids and hyaluronic acid)
* Participates in physical exercise for 30 minutes or more 5 days per week
Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression

This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.

Bipolar disorder is a common lifelong psychiatric disorder. It is characterized by recurrent mood swings with manic or hypomanic episodes alternated with depressive episodes of longer duration. Patients spend more time in depression than in (hypo)mania over their life time. The medical need for the patient is to remain symptom-free for as long a period as possible. A reduction both in severity of depression and mania, and in frequency of cycling, is the aim.

Although there are many treatments for bipolar disorder, few are approved, and they have limitations in their use due to safety and tolerability issues. Recommendations exist to use mood stabilisers, antipsychotics or a combination thereof with or without antidepressants and the polypharmacy employed in many cases is a reason for concern. There is a major medical need for more effective treatments in monotherapy with a reduced potential for adverse effects. This study evaluates the efficacy and safety of the new drug, Lu AA34893, in treatment of depression in patients with bipolar disorder.

Eligibility Criteria:
Inclusion Criteria:

* Current major depressive episode of bipolar I or bipolar II disorder, according to DSM-IV TR
* Moderate to severe depression
* History of at least one documented mania or hypomania episode
* Absence of current mania or hypomania

Exclusion Criteria:

* Any current psychiatric disorder other than bipolar disorder defined in the DSM-IV TR
* Any substance disorder with the previous 6 months
* Use of any psychoactive medication (including mood stabilizers) within 2 weeks before randomisation and during the study
* ECT within 6 months before the study
* Female of childbearing potential and not using adequate contraception

Other protocol-defined inclusion and exclusion criteria may apply
Analysis of Tokuhashi Score

70% of all cancer patients develop some form of visceral (internal organs) or skeletal metastases (spread of disease). Approximately one third of cancer patients develop metastases to the spinal column. The prognosis once spinal metastases have been diagnosed and the most appropriate treatment still remains controversial. To date there is no one good diagnostic tool to predict survival and/or outcome after radiotherapy or surgical intervention.

Tokuhashi, et al, formulated and presented a preoperative scoring system to evaluate indications for surgery and predict outcome in patients with metastases to the spinal column. Six variables are measured to calculate this score: general medical condition, number of extraspinal metastases, number of vertebral metastases, status of metastases to the major internal organs, primary tumor type, and presence of a neurologic deficit. This scoring system has been gaining acceptance in literature. In 1998, Tokuhashi, et al, modified this scoring system by diversifying the tumor types into six categories. After a retrospective analysis Tokuhashi reported that patients with scores less than or equal to 8 will die of their disease within 6 months and those with scores of 12 or greater will survive an average of 12 months or more.

The purpose of this study is to determine 1) the Tokuhashi score's validity in predicting survival after developing spinal metastases, 2) the relationship of treatment on survival after detecting spinal metastases in relation to the Tokuhashi score. Patients will be enrolled into the study and followed prospectively for as long as possible regardless of intervention.

There will be three groups based on their Tokuhashi score, each group will require approximately 163 subjects statistically.

all info is in brief summary

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with any form of spinal metastases, whether symptomatic or not, regardless of tumor biology, and seen by a physician in the Department of Orthopedic Surgery, will be asked to enter this trial.
* Must be a patient of our practice

Exclusion Criteria:

* There is no exclusion criteria
Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire

The purpose of this study was to investigate adaptation, validity, and reliability of the Turkish version of the Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JOAHDEQ).

There are a number of medical assessment tools for various diseases, but in most cases such tools are designed to reflect the perspective of healthcare providers, not perspective of patients. In addition to clinical results, it is necessary to evaluate the quality of life of patients when measuring the effect of medical treatments. Thus, evaluation criteria which can be useful as patient-reported outcome indices, have received increasing attention in recent years. Health-related quality of life provides a patient-reported assessment. Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JOAHDEQ) evaluates quality of life related to hip disorders. It is also a guide in determining the expectations of individuals in the treatment process. It consists of 3 subscales (pain, movement and mental) and 20 items. Hip condition and pain are evaluated with a 100 mm scale. 20 items are scaled likert with values between 0 and 4. "0" means "strongly agree", "1" means "agree", "2" means "uncertain", "3" means "disagree" and "4" means "strongly disagree". The study is planned with 105 individuals with hip disease. After questioning the sociodemographic characteristics of the individuals, the patients will be asked to fill in JOAHDEQ, Oxford Hip Score, International Hip Outcome Tool-12, Short Form-36, and Visual Analog Scale Test-retest will be re-applied to those of the same individuals who can be reached after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.

Eligibility Criteria:
Inclusion Criteria:

* Any diagnosed hip disease,
* Chronic hip pain,
* History of pain when lying or during weight-bearing activities, aggravated by activity for more than 3 months.

Exclusion Criteria:

* Lumbar spine nerve root findings,
* History of lumbar spine or hip surgery,
* Corticosteroid injection to hip in the past 3 months.
Detection of Small Fiber Neuropathy Using Skin Properties

Small fiber neuropathy affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, too much or too little sweating. The detection of nerve damage is complicated and not widely available; it requires either skin biopsy or specialized equipment and training. This project utilizes the mathematical processing of skin pictures for the purpose to extract the statistical features related to loss of small fibers. This approach can improve the availability of diagnosis of small fiber neuropathy.

Small fiber neuropathy, including cardiovascular diabetic neuropathy, affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, urinary problems and cold or hot intolerance. Early and accurate diagnosis of neuropathy is essential for correct treatment. Available diagnostic methods are either invasive such as skin biopsy or available only in few specialized centers. This project addresses the limited availability of small fiber neuropathy detection.

The project utilizes utilize specialized image processing of skin pictures for the purpose to extract the statistical features that are related to loss of small fibers. The accuracy of the diagnosis verified using skin biopsies.

This approach can improve the availability of diagnosis of small fiber neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with age 18 year or older
* Patients that sign the informed consent form to participate in this study
* Patients completed the autonomic testing with skin biopsies

Exclusion Criteria:

* Patients with significant hairs at the legs that will cover the skin
* Any dermatological disorder that can affect the skin composition
* The use of skin lotion
Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population

The aim of this study is to describe the outcomes in American Indian patients receiving immunotherapy in a multi-institution retrospective study at several other high-volume centers that care for this patient population and to identify any healthcare disparities that can lead to future interventional studies.

Immune checkpoint inhibitors have been shown to increase survival in metastatic solid tumor patients when compared to the previously standard of care chemotherapy. Epidemiologic studies of American Indian cancer patients demonstrated having significantly worse survival when compared with Caucasians when controlled for age, sex, alcohol abuse, smoking, insurance, and disease stage.

There are no current studies specifically examining the American Indian population receiving treatment with immune checkpoint inhibitors. The aim is to describe the outcomes in American Indian patients receiving immunotherapy in a multi-institution retrospective study at several other high-volume centers that care for this patient population and to identify any healthcare disparities that can lead to future interventional studies.

Eligibility Criteria:
Inclusion Criteria:

* above age 18,
* histologically and cytologically confirmed NSCLC, melanoma, head and neck squamous cell carcinoma, gastrointestinal cancers,, renal cell carcinoma, or any other solid tumors where immune checkpoint therapy has been used
* received immunotherapy as part of their treatment
* Self-identified American Indian in ethnicity
* Patients at the Stephenson Cancer Center between 2015 to 2021

Exclusion Criteria:

* patients who did not receive immune checkpoint inhibitor therapy
Reader Study of DeltaView™ Chest Radiograph Software

A new software product takes two chest radiographs, aligns them, and then subtracts one image from the other. The resulting image represents an image showing any differences between them. The study is to determine whether radiologists using this new software perform better with it than when they do not use it.


Eligibility Criteria:
Inclusion Criteria:

For Radiologists: American Board of Radiology Certification and live within the Baltimore, MD-Washington, DC Metropolitan areas

For chest radiographs, evidence of the presence or absence of lung nodule confirmed by expert panel; adequate image quality

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Exclusion Criteria:

Radiologists who assisted by providing cases for review

For chest radiographs: poor image quality
Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects

The purpose of this study is to evaluate the efficacy and safety of Systane® Gel Drops in dry eye subjects following 90 days of QID (4 times/day) dosing.


Eligibility Criteria:
Inclusion Criteria:

* Must give informed consent, and be willing and able to attend all study visits.
* Best-corrected visual acuity (BCVA) of ≥ 55 letters in each eye as measured by ETDRS (letters read method).
* Dry eye in both eyes diagnosed by an ophthalmologist.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential who are pregnant, test positive on a pregnancy test, or breast-feeding.
* Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of test article or safe participation in the study.
* Any contraindications or hypersensitivities to the study medications or their components.
* Ocular surgery (of any type, including PRK, LASIK, Epilasik, etc.) or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening.
* Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening.
* Chronic medications (over the counter, prescription, or vitamins) that have not been on a stable dose for at least 30 days prior to Screening.
* Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study.
* Participation in any other clinical trial within 30 days prior to Screening.
* Other protocol-specified exclusion criteria may apply.