cyrilzakka/clinical-trials huggingface dataset:
Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke

The primary objective of this pilot randomized controlled trial (RCT) is to test the feasibility (recruitment rate, retention rate, participant burden, adherence, technical issues, safety) and usability (system usability scale, SUS) of Omnidirectional treadmill Virtual Reality training (omni-VR) among chronic stroke survivors. Our secondary objective is to (1) estimate the extent to which cognition, brain activation during a dual task activity, walking ability, and dynamic balance change after 3 months of training among intervention participants (omni-VR) and traditional exercise controls, and (2) estimate the extent to which health-related quality of life and motivation co-evolve with our secondary outcomes.

Researchers will compare the intervention group and control group to evaluate the impact of omni-VR on cognition and physical function among stroke survivors.

Participants will:

* undergo a 45-minute training session 3 times per week for 12 weeks
* intervention group: omni-VR
* control group: traditional exercise program (strengthening and walking activities)

Mounting data indicates that cognition plays a role in complex walking and balance. However, conventional intervention methods lack a sufficient incentive to encourage participants to adhere to the treatment. Further, it is difficult to provide a substantial amount of treatment to induce cortical reorganization.

Virtual reality or VR (a computer-generated simulation of 3-dimensional virtual environments that reacts in real time to the user's actions) has been introduced to neurorehabilitation to promote improvements in walking ability, balance, and cognition. It has also been demonstrated to be effective in improving motivation among stroke survivors and augmenting neuroplasticity.

Omnidirectional treadmill technology can be integrated with VR to allow for fully immersive rehabilitation. This novel and innovative technology mimics real-world environments and maximizes challenging cognitive and physical dual-tasking and balance activities while maintaining patient safety. However, no randomized trials have evaluated the impact of omnidirectional treadmill VR (Omni-VR) on cognitive and physical function among stroke survivors.

Therefore, our study aims to test the feasibility and usability of the Omni-VR. This pilot randomized control trial will also be the first study to test the feasibility and effect of a fully-immersive active omni-VR system among chronic stroke survivors

Eligibility Criteria:
Inclusion Criteria:

* Stroke ≥ 6 months ago (per conventional stroke trials)
* Living within 50 km of Halifax, Nova Scotia
* Functional Ambulation Category ≥ 3
* Self-reported walking limitations (Walk-12 score \> 20)
* Ability to exercise for ≥ 15 minutes
* No visual deficits or hemispatial neglect
* No other cardiovascular, orthopedic, or neurological diseases impacting walking or balance
* Montreal Cognitive Assessment (MoCA) scores \> 18 indicating moderate or severe cognitive impairment
Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment

To evaluate the safety and efficacy of QGE031 versus placebo in patients with bullous pemphigoid. Efficacy will be assessed as a reduction of disease activity. How QGE031 is broken down by the body and the impact it has on different blood and tissue markers will also be explored.

This study was planned to be divided into 2 distinct parts. Part 1 was a multicenter, randomized, placebo-controlled study evaluating the efficacy, safety, PK and PD of multiple, subcutaneous doses of QGE031 in the treatment of patients with BP with disease refractory to oral steroid treatment. Patients were treated with QGE031 or placebo in a 2:1 ratio.

Part 2 of this study was planned to be a multi-center, open label, dose range finding study evaluating the efficacy, safety, PK and PD of multiple, subcutaneous doses of QGE031 in the treatment of patients with BP with disease refractory to oral steroid treatment.

This study was stopped after Part 1 completed and was terminated because the predefined criteria of efficacy was not reached ( \>50% better then placebo)

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with bullous pemphigoid
* Stable dose of prednisone at or above 10mg per day but no greater than 1 mg/kg/day
* Weigh between 40-120kg
* total IgE level up to 5000 IU/mL

Exclusion Criteria:

* Use of rituximab within 1 year

Other protocol-defined inclusion/exclusion criteria may apply
OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion

The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared to local autograft.


Eligibility Criteria:
Inclusion Criteria:

1. Are 18 (eighteen) years of age or older at the time of surgery.
2. Require spinal fusion using TLIF, PLF or PLIF, with or without the use of an interbody spacer, at 1 to 3 levels between L3-S1.
3. Are willing and able to return for the scheduled follow-up visits, follow post-operative instructions and undergo the required radiographic exams (A/P, Lateral Neutral and Lateral Flexion/Extension X-rays) for up to 4 time points between 3 weeks and 12 months post-surgery (3 months ± 2 weeks, 6±1 months, 12±2 months and if required 24±3 months post-surgery), including one CT-scan at 12±2 months.
4. Are unresponsive to conservative care over a period of at least 6 months or have signs and/or symptoms that mandate urgent surgical intervention.
5. Are willing and able to sign study specific informed consent.

Exclusion Criteria:

1. Are long term users of medications (i.e. steroids greater than 8 days) that are known to inhibit fusion or bone metabolism at any time within 6 months prior to surgery. Exceptions are inhaled steroids for asthma treatment (i.e. patients on inhaled steroids are allowed), or epidural steroid injections.
2. Are taking immunosuppressive agents (Cancer chemotherapy, treatment with Disease Modifying Anti-rheumatic drugs (DMARDs) or any similar immunomodulating drugs) or are treated with Growth Factors or Insulin at any time within 6 months prior to surgery.
3. Are being treated with radiotherapy.
4. Are having medical conditions, known to impact bone metabolism, such as Paget's disease, or has established osteoporosis (i.e. has had one or more fragility fractures).
5. Are pregnant, lactating or women wishing to become pregnant.
6. Are a prisoner.
7. BMI ≥ 40
8. Are smokers and/or nicotine/tobacco users
9. Are currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
10. Had prior spine surgery at the index level except posterior decompressive surgery where the posterior elements are preserved e.g. facet saving techniques such as discectomy, laminotomy, and intradiscal procedures.
11. Use of routine prophylactic NSAIDS for 3 months post-operatively, but low dose concomitant pain medications e.g. aspirin should be continued and recorded on the Concomitant Pain Medications case report form (CRF).
Drug and Dose Adjustment in Preventing Postoperative Nausea and Vomiting

The aim is to evaluate the effectiveness of different regimens of prophylactic Ondansetron, Dexamethasone, or both, on the incidence and severity of post-operative nausea and vomiting.

Patients will be randomized to one of four arms: Ondansetron (4O-PE: 4 mg Ondansetron pre-emergence, 8O-PE: 8 mg Ondansetron pre-emergence, 4O-PI: 4 mg Ondansetron pre-incision, 8O-PI: 8 mg Ondansetron pre-incision), Dexamethasone (4D-PE: 4 mg Dexamethasone pre-emergence, 8D-PE: 8 mg Dexamethasone pre-emergence, or 4D-PI: 4 mg Dexamethasone pre-incision, or 8D-PI: 8 mg Dexamethasone pre-incision), Combination Therapy group (4O-PI+8D-PI: 4 mg Ondansetron pre-incision + 8 mg Dexamethasone pre-incision, 4O-PI+8D-PE: 4 mg Ondansetron pre-incision + 8 mg Dexamethasone pre-emergence, 4 O-PE+8D-PI: 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction, 4 O-PE+8D-PE: 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence), and Placebo group 2 ml Saline 0.9%. Primary outcome will be the incidence of PONV in the PACU prior to discharge.

Eligibility Criteria:
Inclusion Criteria:

* ASA grade I and II
* Aged 18-70 years
* Patients scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* All patients who received antiemetics or cortisone within 48 hr before surgery
* Pregnant, breast feeding ladies
* Any patient with BMI (Body Mass Index) \> 34 kg/m²
* Patient with gastrointestinal, hepatic, renal, mental or psychiatric illnesses were also excluded from the study protocol.
Clinical Evaluation of the Xpert® HIV-1 VL

Compare the clinical performance of the Xpert® HIV-1 VL to another FDA approved HIV-1 RNA quantitative assay using frozen and fresh specimens from known HIV-1 positive individuals.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 seropositive adults using an FDA approved method
* At least 18 years of age or older
* Informed consent, if applicable

Exclusion Criteria:

* Subject is less than 18 years of age
* Previously enrolled in this study
* Samples not collected according to the procedure
eCulinary Medicine Emphasizing Herbs/Spices to Increase Vegetable Intake

e-Culinary medicine emphasizes on herbs and spices, will increase consumption of vegetables and reduce sodium in the diets of people with hypertension and lead to a more favorable health profile.

This will be a randomized controlled intervention in collaboration with physician care clinics. Participants with hypertension will be assigned to an eCulinary medicine group (E-group) or control that will receive recipes without the eCulinary intervention (C-group). The intervention group will receive weekly cooking demonstration videos, a one-time nutrition education session based on the content of the Nutrition Care Manual from the Academy of Nutrition and Dietetics, a bi-weekly phone visit, and will be given a digital blood pressure monitor and a digital weight scale. The cooking demonstrations will focus on utilizing herbs and spices in the preparation of various vegetables using different cooking methods aimed to reduce sodium and increase vegetable consumption. The control group will receive only recipes from the eCulinary intervention as well digital blood pressure monitor and a digital weight scale.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis hypertension
* Age above 18

Exclusion Criteria:

* Use of tobacco
* Self-reported history of chronic diseases other than hypertension
* Allergy to any food
* Pregnant or lactating
* Alcohol or drug dependence
Melatonin and Its Effect on the Perioperative Opioid Needs in Pediatric Patients Undergoing Laparoscopic Surgery.

To study the role of Preoperative Melatonin adminsteration in pediatric patients undergoing laparoscopic surgeries regarding its analgesic and sedative effects


Eligibility Criteria:
Inclusion Criteria:

* Age from 2 to 10 years.
* Sex: Both sexes.
* Patients with ASA classificaion I and II.

Exclusion Criteria:

* Declining to give written informed consent.
* History of allergy to the medications used in the study.
* psychiatric disorder.
* ASA classification III-V.
* Fever ,cough , asthma or upper respiratory tract infection, neuromuscular disorders, spine abnormalities.
* Anticipated difficult airway .
* History of malignant hyperthermia
Mode of Action of Topiramate in the Treatment of Obese Patients With and Without Type 2 Diabetes Mellitus

The purpose of this study is to explore the mode of action of topiramate in the treatment of obese and diabetic patients by testing association between genetic variations within candidate genes or chromosomes (thread like structure found in cell which carries genes) and the clinical outcomes.

This pharmacogenomics (effect of genetic variation on drug response) study will analyze genetic variations in the DNA extracted from blood samples collected from patients who were randomized (assigned to treatments by chance) in 1 of 3 previous topiramate studies on obesity and diabetes. The study consist of a screening telephone contact, a single visit to the study site for a blood sample collection (10 ml of whole blood) for genetic analyses, and a 24-hour post-sample adverse event reporting period. The total duration of the study is 24 hours from the time of the blood sample collection. Safety will be monitored up to 24 hours after blood sample collection. No study medication was administered.

Eligibility Criteria:
Inclusion Criteria:

* Must have been randomized within the previous topiramate obesity and diabetes studies: PRI/TOP-INT-31 or PRI/TOP-INT-33 or a subset of patients with diabetes mellitus who were randomized within the PRI/TOP-INT-34 study at sites that also participated in the PRI/TOP-INT-31 study
* Must consent to participate and use data from previous clinical trials in connection with results from the genetic analyses

Exclusion Criteria:

* Patients who received a blood transfusion within 60 days before collecting DNA samples
Safety Study of Tarceva in Children With Refractory and Relapsed Malignant Brain Tumors and Newly Diagnosed Brain Stem Glioma

The purpose of this study is to establish the recommended dose/Maximum Tolerated Dose (MTD) of Tarceva in children as single agent and in combination with radiation therapy

Prognosis in relapsing malignant brain tumors is poor. Those in brain stem gliomas is dismal; median survival of these children does not exceed 9 months. Radiation therapy may result in early and transient amelioration of symptoms, but have not contributed to increase or prolong survival. Moreover, chemotherapy has not increased this outcome to date.Prados et al. reported encouraging results from a phase I study of TarcevaTM/OSI-774 alone or with temozolomide (TMZ) in patients with malignant gliomas. Of 25 evaluated patients, 6 experienced PR: 4 GBM (glioblastoma multiforme) and 1 grade 3 astrocytoma treated with TarcevaTM alone, 1 GBM treated with TarcevaTM/TMZ; 2 had minor responses, and 3 stable diseases. These results in malignant glioma and the lack of efficacy in brain stem glioma with current treatment suggests the evaluation of this new therapeutic agent in children with relapsed brain tumors and upfront at diagnosis in brain stem glioma in combination with radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed malignant brain tumor
* Disease must be considered refractory to first line or relapsing after conventional therapy and for which no effective conventional treatment exists.·
* Newly diagnosed, histologically proven brain stem glioma, except pilocytic astrocytomas.
* Age: 1 to ≤ 21 years of age at study entry
* Life expectancy: at least 8 weeks
* ECOG Performance status ≤ 1 or Lansky-Play Scale\>= 70%, and including children with motor paresis due to disease
* Measurable or evaluable disease
* No other serious concomitant illness
* No organ toxicity \> grade 2 NCI-CTC AE v3.0, except alopecia and neurological symptoms due to disease

Exclusion Criteria:

* Patients with spontaneous intratumoral hemorrhage will not be included in the study, in exception of small post-biopsy hemorrhage due to biopsy procedure
* Pregnant and breast feeding woman
* Uncontrolled intercurrent illness or active infection
* Chemotherapy within 4 weeks prior to study medication (within 6 weeks, if the regimen contained a nitrosourea)
* Radiation therapy within 6 weeks prior to study medication
* Any clinical or non-clinical evidence of pulmonary dysfunction or pre-existing lung disease
* Severe cardiac pathology; history of myocardial infarction within the year prior to inclusion
* Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions
* Treatment with Coumarin (warfarin)
Complementary Medicine Approaches to TMD Pain Management

This study will determine whether selected complementary approaches to temporomandibular joint (TMJ) pain management-acupuncture are as effective as usual care.

Temporomandibular disorders are characterized by pain and tenderness in the muscles of mastication and/or the (TMJ), limitations of jaw opening often accompanied by deviations in mandibular path, and clicking, popping or grating TMJ sounds. This study will compare the effectiveness of the complementary therapies chiropractic therapy and bodywork therapy to the standard of care for TMJ pain. If these complementary interventions are shown to be effective, the goal is to design and implement a Phase III clinical trial to further evaluate the health consequences and cost of these therapies.

Participants will be evaluated at baseline, and 6 and 12 months post-intervention. Clinical examinations, saliva samples to assess salivary cortisol levels, and a series of questionnaires to assess pain and grade of dysfunctional pain, psychological functioning, and other physical symptoms will be used to assess outcomes. The investigators will passively monitor health care utilization within KPNW using clinical, research, and administrative databases.

Eligibility Criteria:
Inclusion Criteria:

* Psychologically functional TMD patients
A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.

The main objectives of this study are to evaluate the safety and tolerability of bemarituzumab in combination with other anti-cancer therapies, and to evaluate the efficacy of bemarituzumab in combination with S-1 and oxaliplatin (SOX) and nivolumab as assessed by objective response.


Eligibility Criteria:
Inclusion Criteria:

* Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amendable to curative therapy.
* Ability to provide tumor sample, either archival (obtained within 6 months to joining study) or fresh biopsy.
* For certain arms for Part 1, FGFR2b overexpression positive defined as any FGFR2b 2+/3+ TC determined by centrally performed immunohistochemistry (IHC), based on tumor sample provided.
* For Part 2, FGFR2b overexpression positive defined as FGFR2b ≥10% 2+/3+ TC determined by centrally performed IHC testing, based on tumor sample provided.
* Easter Cooperative Oncology Group (ECOG) performance score less than or equal to 1.
* Measurable or non-measurable disease as long as evaluable by Response Evaluation Criteria Solid Tumors (RECIST) version 1.1
* Participant has no contradictions to CAPOX/SOX plus or minus nivolumab.
* Adequate organ function.
* For Part 2, measurable disease according to RECIST v1.1.

Exclusion Criteria:

* Prior treatment for metastatic or unresectable disease (Note: prior adjuvant or neo-adjuvant therapy for local disease is allowed if ended more than 6 months of 1st dose).
* Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway.
* Known human epidermal growth factor receptor 2 (HER2) positive
* Untreated or symptomatic central nervous system (CNS) disease or brain metastases.
* Peripheral sensory neuropathy greater than or equal to Grade 2.
* Clinically significant cardiac disease.
* Other malignancy within the last 2 years (exceptions for definitively treated disease).
* Chronic or systemic ophthalmological disorders.
* Major surgery or other investigational study within 28 days of first study treatment dose.
* Palliative radiotherapy within 14 days of first study treatment dose.
* Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.
* History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmic corticosteroids.
Do Traditional or Flavored Tongue Depressors Make for Easier Posterior Oropharynx Exams in Pediatric Patients

Evaluation of the oropharynx is a standard component of a general medical exam for all pediatric patients, but is an essential exam in the undifferentiated ill child. Pediatric patients are unable to verbalize where they hurt, and a comprehensive evaluation is needed to identify the source of fever and illness. Frequently, illnesses will present atypically as well, and a patient complaining of abdominal pain may ultimately be diagnosed with streptococcus pharyngitis. If the examiner does not evaluate the posterior oropharynx, the throat as a cause of abdominal pain is easily overlooked. Additionally, young children are prone to infections with pox viruses causing herpangina, hand foot and mouth disease, oral thrush. Despite the importance of the posterior oropharynx exam, it can be a source of stress and anxiety for both the clinician and pediatric patient when a tongue depressor is used to evaluate the posterior oropharynx. However, there are no studies to date that have looked at decreasing the difficulty or at decreasing the perceived discomfort associated with the poster oropharynx exam in the pediatric patient when a tongue depressor is utilized. Despite this paucity of research, there are multiple different flavored and candied tongue depressors available for this purpose which may or may not aid in obtaining posterior oropharynx exam and decrease the discomfort experienced by the patients.

The study design is a prospective, placebo-controlled, randomized controlled trial using a convenience sample of 96 pediatric patients presenting for care in the emergency department who require an oropharyngeal examination as part of their evaluation. Examinations will be performed utilizing either traditional (unflavored) or flavored tongue depressors in a random fashion. . Physician/provider investigators will complete a brief survey after each exam as to the ease of the exam and the perceived emotional discomfort the exam experienced by the subject, both recorded on a visual analog scale. The age and sex of the subject, and the education level of the investigator will also be recorded. A single question survey will also be provided to the parent/caregiver as to their perception of the discomfort of their child during the posterior oropharynx exam using a visual analog scale. Additionally, a single question survey will be posed to the subject asking for their discomfort level during the exam using the Oucher pediatric pain scale.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients between 3 and 12 years of age presenting to the emergency department who require the use of a tongue depressor to evaluate the posterior pharynx as part of their clinical evaluation.

Exclusion Criteria:

* Patients who do not require a tongue depressor to fully examine the posterior oropharynx, patients who are immunocompromised and patients who are younger than 3 years of age or older than 12 years of age. We will also exclude patients with abnormal facies, and any patients with altered mental consciousness as defined by a GCS less than 15.