cyrilzakka/clinical-trials huggingface dataset:
The Effect of Augmented Reality Based Telerehabilitation Application on Neuromuscular and Sensorimotor Parameters in Multiple Sclerosis Patients

Core stability, which is affected from the early period in with patients Multiple Sclerosis (PwMS), is due to deterioration in the somatosensory, motor and musculoskeletal systems. Based on the knowledge that core stability is effective on many functions, it is seen that trunk stabilization exercises are included in the physiotherapy and rehabilitation programs of patients. However, the effectiveness of augmented reality-based telerehabilitation application, which includes trunk stabilization training in PwMS, has not been adequately investigated in the literature. The aim of the study is to investigate the effectiveness of augmented reality-based telerehabilitation application, which includes trunk stabilization training, on neuromuscular and sensorimotor parameters in PwMS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with relapsing remitting MS by a neurologist,
* Having a disability level between 1 and 5 according to the Expanded Disability Status Scale (EDSS),
* Those who get over 24 points in the Standardized Mini Mental State Test (SMMT),
* Those who have not had an MS attack in the last three months,
* Volunteer individuals

Exclusion Criteria:

* Receiving corticosteroid therapy in the last 4 weeks,
* Having additional neurological disease that may cause balance disorder
* Individuals who have had surgery related to the spine, hip, knee or ankle
Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs

Intradiscal delivery of bone marrow concentrate (BMC) into discs, facet, epidural space, and sacroiliac joints

To study if the outcomes for the injection of bone marrow concentrate (BMC) in patients with disc, facet, epidural space, and sacroiliac joint pain create a clinically meaningful improvement in pain and function. Further analysis will determine if there be any variance in patient reported outcome due to the individual's pre-procedure cell count and analysis.

Hypothesis 1: An injection of autologous BMC into discs, facets, sacroiliac joints, and epidural space will improve pain and function in patients with IDD

Hypothesis 2: There will be a direct relationship between an individual's BMC composition and the patient's reported outcomes

Eligibility Criteria:
Inclusion Criteria:

* A high index of suspicion for discogenic pain, i.e. painful degenerative discs with or without protrusions/herniations and facet/sacroiliac joint pain
* Patients with mild to severe spinal stenosis
* Patients with radiculopathy
* Patients with disc extrusions
* Patients with failed spinal fusion
* Patients with mild to severe facet arthropathy
* Patients with suspected sacroiliac joint disease
* Age 18 to 60 years
* Mild to severe loss of intervertebral disc height
* Pain is not responsive to conservative treatment measures (oral medication, epidural steroid injections, physical therapy)
* Pain persists for an extended period of time (i.e., at least 3 months)
* High intensity zone (HIZ) in annular fissure or adjacent to annular fissure detected on T2 or STIR MRI
* No evidence of contraindications to undergo procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer
* English speaking

Exclusion Criteria:

* Spinal Deformity (Scoliosis \>20 degrees, Spondylolisthesis)
* Sequestered fragments, severe thecal sac compression
* Severe neurologic deficit
* Non-English speaking
* Bone marrow disorders
* Immunosuppressed Patients
* Patients with coagulopathy
* Localized infection in the area of skin penetration
* Spinal infection
* Serious medical co-morbidities
To Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults

The purpose of this study is to evaluate pharmacokinetic interaction and safety of co-administrated 25mg of Empagliflozin and 10/10mg Ezetimibe/Rosuvastatin in steady state in healthy volunteers.

This trial is a phase 1 study to evaluate pharmacokinetic interaction and safety of co-administrated 25mg of Empagliflozin and 10/10mg of Ezetimibe/Rosuvastatin in steady state in healthy volunteers.

This is open-label, multiple-dose, two-arm, two-period and fixed-sequence design.

In Arm A, 18 subjects will be assigned. The subjects take 25mg of empagliflozin for 5days(Period 1). After 7days of washout period, the subjects take 10/10mg of Ezetimibe/Rosuvastatin for 2days and take co-administrated 25mg of Empagliflozin and 10/10mg of Ezetimibe/Rosuvastatin for 5days.

In Arm B, 38 subjects will be assigned. The subjects take 10/10mg of Ezetimibe/Rosuvastatin for 7days(Period 1). After 14days of washout period, the subjects take 25mg of empagliflozin for 2days and take co-administrated 25mg of Empagliflozin and 10/10mg of Ezetimibe/Rosuvastatin for 5days.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age: 19 and over , healthy volunteer
* Body mass index (BMI): 18.5≤BMI≤29.9 kg/m²

Exclusion Criteria:

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal
* Clinically relevant findings(e.g. blood pressure, electrocardiogram(ECG); physical and gynecological examination, laboratory examination)
Preoperative Clear Liquid Diet Fasting; Survey Among Medical School Physician

To determine knowledge and practice about liquid diet fasting among physicians in a Quaternary-care academic center

study decide: questionnaire based study to ask concerning and knowledge and practice about liquid diet fasting and other diet fasting.


Eligibility Criteria:
Inclusion Criteria:

* physician who have opportunity to order fasting for surgical patient.

Exclusion Criteria:

* none
Ozonized Gel vs Gaseous Ozone Against S. Mutans in Deciduos Molars Caries

The aim of this study is to verify, through bacteriological analysis, the efficacy of reducing the bacterial load referred to the presence of Streptococcus Mutans in carious lesions of viable deciduous molars by application of gaseous ozone or ozonized gel.

Patients who meet the eligibility criteria and for whom the legal guardians have signed the informed consent, will undergo treatment of the carious lesion with gaseous ozone or ozonized gel. After selective removal of dentin, a bacterial sample will be taken from the carious surface with a sterile paper cone at time T0; then ozone will be applied for 30 seconds, the surface will be washed with sterile saline and dried with air, a second sample will be taken at time T2; finally, ozone will be applied for another 30 seconds, the surface will be washed with sterile saline and dried with air, a third sample will be taken at time T2.

Patients are then randomised into two groups:

Test group: gaseous ozone (Healozone X4) is applied to the carious lesion for 30 seconds and then for another 30 seconds.

Control group: ozone gel (GeliO3) will be applied to the carious lesion for 30 seconds and then for another 30 seconds.

Changes in the following indices will be assessed at the first visit and when the samples are taken at T0, T1, T2: compliance assessment (FLACC scale), sensitivity test (Schiff Air Index), assessment of lesion severity and extent (ICDAS), assessment of gingival inflammation (GI), assessment of plaque index (PI), assessment of severity of enamel erosion (Bewe index).


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from carious lesion on viable deciduous molar
* patients' compliance

Exclusion Criteria:

* patients with early loss of deciduous molars for carious lesions or orthodontic reasons
* non-viable deciduous molars
* deciduous molars with traumatic lesions
Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer

The study aims to investigate the prognostic and postoperative complication relevance of lymphadenectomy in advanced epithelial ovarian cancer patients who received neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The main question it aims to answer is:

Does systematic lymphadenectomy during interval debulking surgery have a significant impact on survival in patients with advanced epithelial ovarian cancer who have received neoadjuvant chemotherapy?

The progression-free survival (PFS), overall survival (OS), and postoperative complication were compared between the lymphadenectomy and no lymphadenectomy groups to answer the question.

The study aims to investigate the prognostic and postoperative complication relevance of lymphadenectomy in advanced epithelial ovarian cancer patients who received neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The study included patients with histologically confirmed advanced epithelial ovarian cancer who received IDS at seven tertiary hospitals in China from 2006 to 2021. The progression-free survival (PFS), overall survival (OS), and postoperative complication were compared between the lymphadenectomy and no lymphadenectomy groups. Propensity score matching (PSM) and overlapping weight (OW) analyses were performed to minimize selection bias.

Eligibility Criteria:
Inclusion Criteria:

1. Consecutive patients with advanced epithelial ovarian cancer (stage IIB-IV, according to the International Federation of Gynecology and Obstetrics (FIGO) 2014);
2. Patients who underwent NACT followed by IDS.

Exclusion Criteria:

1. Patients with early-stage ovarian cancer (FIGO stage I-IIA);
2. Patients only receiving primary debulking surgery (PDS) as initial treatment without NACT;
3. Histological subtypes other than advanced epithelial ovarian cancer;
4. Patients with unclear sites of lymphadenectomy and non-compliant systematic lymphadenectomy that not include pelvic and/or para-aortic lymph nodes.
Analysis of Tumors From Patients With Inherited Cancers Having Had Two Surgeries (Primary + Recurrent, or 2 Separate Types of Cancer)

This study will analyze tumor tissue from patients with known genetic mutations (BRCA1, BRCA2, CHK2, etc) who have tumor tissue available from two surgeries, either primary/recurrent, or two different anatomical sites.

This study will recruit individuals with known BRCA1 and BRCA2 mutations or mutations in similar cancer causing genes such as CHK2 or PALB2 who have had a cancer removed by surgery or biopsied two or more times with available pathological blocks. We wish to enroll individuals who have had more than one surgery or biopsy for cancer allowing us to obtain tumor blocks from more than one time point. Such patients would include those with one cancer which has recurred or more than one separate cancer. We will conduct a brief interview with the subject to obtain personal information about medical and treatment history. In addition, we will collect clinical information from their treating physician(s) to correlate molecular findings with clinical responses to treatment and survival and recurrence data. We will collect background clinical information and family history information and a copy of the genetic test results documenting their cancer causing mutation. We will recruit only patients with known BRCA1 or BRCA2 mutations or known mutations in other cancer causing genes such as CHK2 or PALB2 and will not perform genetic testing on non-tumor tissue for any new information on genetic susceptibility in patient samples. Enrolled subjects will donate a blood sample that will be obtained locally and shipped to the research laboratory, and this cost will be entirely covered by the research group.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18 or older
* documented mutation in BRCA1, BRCA2 or other known cancer causing gene
* one or more cancer with available stored tissue blocks or slides
* willing to donate 16cc of blood
* able to understand English and provide informed consent

Exclusion Criteria:

* unable or unwilling to provide informed consent
* patient does not have tissue blocks available
* minor, under age 18
Shoulder Surgery Traditional vs Accelerated Rehabilitation Trial

This is a randomised controlled trial involving patients who have a double-row arthroscopic rotator cuff repair.

Null hypothesis: There is no difference in outcome between standard rehabilitation and accelerated rehabilitation after arthroscopic rotator cuff repair.

Following surgery, they will be randomised to one of two groups:

1. Standard rehabilitation, with enforced sling use for 6 weeks and a structured exercise programme.
2. Accelerated rehabilitation with no requirement to use a sling and a structured exercise programme.

The primary outcome measure will be the Oxford Shoulder Score at 6 months. We will also collect data on postoperative pain, range of shoulder movement and other subjective outcome measures. All patients will have MRI scans at 6 months postoperatively to assess the integrity of the repair, allowing comparison of failure rates between groups.

This is a randomised controlled trial involving patients who have a double-row arthroscopic rotator cuff repair. We wish to compare clinical and radiological outcomes for patients undergoing standard rehabilitation protocols versus accelerated rehabilitation.

A double-row repair will be used in this study as it has been shown in laboratory testing to be stronger and withstand significantly more cyclical loads before failure.

Patients who have failed conservative treatment for their rotator cuff tears will be offered inclusion in the study. Baseline scores and measurements will be taken prior to surgery. After a successful surgical repair has been confirmed, patients will be randomised to one of two rehabilitation programmes. One programme will mandate use of a sling for 6 weeks, and another will not require use of a sling after the immediate postoperative period.

All patients will be followed up for one year, at intervals of 6 weeks, 3 months, 6 months and 12 months, using subjective outcome measures, objective measures of movement and an MRI scan to assess the integrity of the repair at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged over 40 with a degenerate full-thickness posterosuperior rotator cuff tear undergoing arthroscopic rotator cuff repair (+/- concomitant procedures such as biceps tenotomy and subacromial decompression).

Exclusion Criteria:

* Other musculoskeletal disease affecting same limb
* Massive rotator cuff tear
* Subscapularis tear
* Incomplete cuff repair
* Repair under tension
* Non-English speaker
* Inability to follow postoperative instructions / restrictions
Creatine Supplementation in Autism Spectrum Disorder

Autism Spectrum Disorder (ASD) is accompanied by reduced levels of total creatine in right temporal-parietal junction and other brain regions of interest, and addressing this deficit by exogenous administration of creatine may have beneficial effects on brain metabolism and disease-specific clinical symptoms in patients suffering from ASD.


Eligibility Criteria:
Inclusion Criteria:

* Age 10 years and above
* Informed consent signed by a parent or legal guardian or legal representative
* Diagnostic and Statistical Manual of Mental Disorders-IV criteria for ASD.

Exclusion Criteria:

* Pregnant or nursing female patients
* Non-pharmacologic therapy
* Current diagnosis of other mental disorder
The Role of Aromatherapy With Lavender Oil in the Long-term Care on a Patients Behavioral Problems Associated With Dementia

Testing of Lavender Oil aromatherapy effect on behavior disorders in patients with severe dementia who are hospitalized in the ward for the mentally frail.

Dementia as one of the most debilitating diseases presents with decline in memory and cognitive functions causing reduction in the intellectual abilities and every day functions. Today, there are estimated 24 million people suffering from dementia world wide and those numbers are expected to double every 20 years (Qiu, De Ronchi, \& Fratiglioni, 2007).

About 80% of all patients suffering from dementia will develop at some point behavioural and psychological symptoms (BPSD)(Aalten et al., 2003). These symptoms will develop in at least 50% of patients treated in outpatient setting and in 75% of patients in nursing homes (Zaudig, 2000).

The behavioural and psychological symptoms (BPSD) syndrome may lead to high degree of distress in the patient and close-once, causing burnout of the primary care giver and transfer of the patient to a nursing home.

These days, the primary treatment is based on antipsychotic pharmacotherapy that is often associated with side affects and far from assured efficiency and safety (Fung, Tsang, \& Chung, 2012). Research showed that the usage of antipsychotic drugs increases the chance of stroke and premature death and thus, the food and drugs administration (FDA) recommends to avoid the usage of these drugs in treatment of dementia (Ballard et al., 2009).

Non-pharmacological approach represents a good alternative in treatment of behavioural and psychological symptoms (BPSD). During the last decade the usage of alternative medicine is increasing (Fung et al., 2012), including the usage of aromatherapy in order to reduce anxiety and restlessness in dementia patients (Hersh \& Falzgraf, 2007).

The treatment of behavioural and psychological symptoms (BPSD) with aromatherapy is being used for years in order to improve sleep and reduce behavioural abnormalities. However, the amount of research that studies the efficacy of aromatherapy in dementia patients is limited (Fung et al., 2012). There is lack of conclusive evidence and knowledge in the effects of dementia treatment using aromatherapy. There are two possible explanations for the conflicting and inconclusive results of studies in this area:

1. Period of treatment was too short (few minutes a day for only a week).
2. The treatment was applied far from the olfactory system (e.g., legs)

In order to confront these issues, the investigators are planning a study that will take place over the course of 4 month and will compare the treatment of aromatherapy close to the olfactory systems (i.e., face) and distant from it (i.e., legs).

Eligibility Criteria:
Inclusion Criteria:

1. Patients hospitalised in the mental frail wards of the "Mental Health Centre, Beer-Sheva".
2. Patients diagnosed with dementia (of all kinds).
3. Patients with informed consents from their guardians

Exclusion Criteria:

1. Patients without informed consent.
2. Patients with hypersensitivity to Lavender Oil
Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil

The primary objective of this study is to gather post market data on the Penumbra SMART COIL® System (Smart System) in the treatment of intracranial aneurysms and other malformations.

This is a prospective, multi-center registry of patients treated in accordance with the cleared indications for the Smart System (Smart), Penumbra Coil 400TM (PC 400), and Penumbra Occlusion Device (POD®). Data for each patient are collected in accordance with the standard of care at each participating hospital through one-year follow-up. Approximately 1,000 patients with intracranial aneurysms or other malformations treated by the Smart System at up to 100 centers will be enrolled. It is anticipated patient enrollment will take 3 years. All patients are to be assessed in accordance with the standard of care at each participating hospital through one year follow-up.

Eligibility Criteria:
Inclusion Criteria:

Patients enrolled in this study must sign the Informed Consent Form and be treated according to the cleared indications for the Smart, PC 400, and POD, which include the embolization of:

* Intracranial aneurysms
* Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae

Exclusion Criteria:

* Life expectancy less than one year
* Smart, PC 400, or POD account for less than 75% of total number of coils implanted
* Participation in another clinical investigation that could confound the evaluation of the registry device
Study of BIIB092 in Participants With Progressive Supranuclear Palsy

The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 \& 4 laboratory abnormalities.

The Secondary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by the Clinical Global Impression of Change (CGI-C) at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) at Week 52 and to assess the impact of BIIB092 on quality of life, relative to placebo, as measured by change from baseline on the Progressive Supranuclear Palsy Quality of Life scale (PSP-QoL) at Week 52.

This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.

Eligibility Criteria:
Key Inclusion Criteria:

* Participants with probable or possible PSP
* Able to ambulate independently or with assistance
* Able to tolerate MRI
* Have reliable caregiver to accompany participant to all study visits
* Score greater or equal to 20 on the Mini Mental State Exam (MMSE) at screening
* Participant must reside outside a skilled nursing facility or dementia care facility at the time of screening and admission to such a facility must not be planned

Key Exclusion Criteria:

* Presence of other significant neurological or psychiatric disorders
* Diagnosis of amyotrophic lateral sclerosis (ALS) or other motor neuron disease
* History of early, prominent rapid eye movement (REM) sleep behavior disorder
* History of or screening brain MRI scan indicative of significant abnormality
* Known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean for the laboratory performing the assay

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply