cyrilzakka/clinical-trials huggingface dataset:
Oral Stereognosis in Completely Edentulous Patient With Maxillary Tori

This study aimed to evaluate the oral stereognosis in completely edentulous patients with palatal tori. Oral stereognosis is tested using different test specimens in completely edentulous patients with maxillary tori and completely edentulous patients without maxillary tori.

Oral Stereognosis has been defined as appreciation of the form of objects that is explored intra-orally. In this study the oral stereognosis is determined by placing objects of various shapes in the patient's mouth and having the patient identify the correct form. Several studies has proved that oral stereognosis ability (OSA) can be used as a predictor for determining the ability of the patients with missing teeth to adapt to a new prosthesis placed in the patient's mouth.

Maxillary tori is a non-cancerous bony swelling found in palate and have high prevalence among Malaysian population. Whether OSA is higher or lower in patients with maxillary tori is not known.

Eligibility Criteria:
Inclusion Criteria:

* Complete edentulous patient with maxillary tori and without maxillary tori
* Complete edentulous patient who were willing give consent and eager to participate

Exclusion Criteria:

* Patients with swallow and mastication dysfunction
* Patients with cognitive disturbances
* Uncooperative patients.
* Patients with oral lesions, pathologies and Tempromandibular Joint disorders.
* Patients with systemic diseases
* Patients allergic to acrylic resin
The Effect of Acupressure and Reiki on Pain and Fatigue Levels

This research was conducted with the aim of determining the effect of levels of pain and fatigue of acupressure and Reiki application on cancer patients receiving palliative care. The research was a single-blind, repeated measures, randomized controlled study. Research data were collected between February and July 2022. The research sample consisted of acupressure and Reiki application groups and a control group with 52 patients in each group, a total of 156 patients. Data was collected by means of a Patient Description Form, an Analgesic Follow-up Form, the Eastern Cooperative Oncology Group Performance Status Scale, the Numeric Pain Rating Scale, and the Brief Fatigue Inventory.


Eligibility Criteria:
Inclusion Criteria:

1. having a diagnosis of third or fourth-stage cancer,
2. being aged 18 years or older,
3. having had pain for at least one month in connection with cancer treatment or the symptoms of the disease,
4. using NSAII or non-opioid analgesics,
5. having a status of 3 or more on the Numeric Pain Rating Scale (NPRS),
6. having a score of 0-3 on the ECOG-PS scale

Exclusion Criteria:

1. having a diagnosis of first or second-stage cancer,
2. being aged less than 18 years,
3. having bone or brain metastasis,
4. using opioid analgesics,
5. having a status of less than 3 on the NPRS,
6. having a status of between 4 and 5 on the ECOG-PS scale
The Motility Mother-Child Cohort

The overall aim of the project is to investigate how bowel habits and nutrition in early life relate to the infant gut microbiome and metabolome from birth to 1 year of age. By unravelling links between these factors in early life, we might be able to identify new putative mechanisms by which diet via microbiota-dependent pathways affects intestinal motility in early life. Furtermore, it will be explored how the development of the gut microbiome associates with the child´s development.

A cohort including 125 mother/infant pairs will be established with the purpose of following the infants' progression in diet, bowel habits, gut and oral microbiome, gut and oral metabolome, physiological and mental development from birth to 12 months of age. This will be possible by longitudinal collection and analysis of biological samples and data from birth until 1 year of age.

The primary hypotheses to be tested are that early dietary patterns (composition, complexity, quality, and timing) and bowel habits (stool frequency, consistency, and transit time) are associated with the development of the infant gut microbial composition and metabolism.

The secondary hypotheses to be tested are that the development of the infant gut microbial composition and metabolism associate with growth (body weight, length, body mass index, head circumference, body composition), development of the immune system as reflected in the gut (fecal cytokines, immunoglobulins, lipopolysaccharide, antigens) as well as the systemic circulation (blood cytokines, immune cells), host metabolism (blood metabolome, appetite hormones, urine metabolome), and physical development (sleep, motor development, mental development).

The tertiary hypotheses to be tested are that the establishment and development of the infant gut microbiome is associated with external environmental factors (household, siblings, maternal diet, maternal fecal microbiome, maternal physical activity, birth conditions, and perinatal factors), and internal factors (infant oral cavity, tooth development, use of pacifier).

Eligibility Criteria:
Mothers Inclusion Criteria:

* Age: 18-40 years of age at inclusion
* Speaking Danish (since all written and oral information will be in Danish)
* Willing to store their child's biological samples in a small closed container in their own freezer at home

Mothers Exclusion Criteria:

* Gestational age more than 34 weeks at time of recruitment
* Diagnosed with gestational diabetes during this current pregnancy
* Diagnosed with preeclampsia during this current pregnancy
* Diagnosed with any severe or chronic diseases\*
* Expecting triplets or higher order of multiple pregnancy
* Concurrent participation in another study
* Not capable of following the examinations according to the investigator´s instructions

Infants Inclusion Criteria:

- Gestational age at birth: 36 weeks or later

Infants Exclusion Criteria:

- Severe chronic illness
COVID-19 Brain Injury

A prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on outcomes of neurologically injured ICU patients.

COVID 19 pandemic has overwhelmed healthcare capacity in many regions around the world. As resources become more limited and we have to triage /ration ventilators, neurologically injured ICU patients without COVID 19 but with respiratory insufficiency may be triaged to no ventilator care due to their perceived or actual prognosis. This may lead to increased rates of withdrawal of care and mortality. Some neurologically injured ICU patients with respiratory insufficiency may be simultaneously infected with COVID 19. Their outcomes are completely unknown. Capturing data on the prevalence of limitation of care and prognosis in this patient population will provide important information towards ongoing efforts in patient care and resource utilization as we face the rapidly evolving COVID 19 pandemic. Given the expected strain on ICU resources and limitations in research in ICUs during COVID 19 pandemic, data capture/study design must be targeted and pragmatic. This study is designed to answer the most basic and important questions while minimizing the burden of data collection on already overloaded providers.

This study design is comprised of two components: Component 1- Prospective cohort prevalence study captures data related to treatments offered, limitations of care and patient outcome in 5 select primary neurological diagnoses requiring ICU care. Component 2- Case control study captures the same data elements in the same patient populations during the 3 months prior COVID 19 pandemic (Sept - Dec, 2019).

Eligibility Criteria:
Inclusion Criteria:

* Patients greater than or equal to 18
* Patients who require critical care with primary diagnoses of: Acute ischemic stroke (AIS), acute intracerebral hemorrhage (ICH), acute subarachnoid hemorrhage (SAH), acute traumatic brain injury (TBI), status epilepticus (SE) patients requiring critical care

Exclusion Criteria:

* Patients under the age of 18 years old
* Pre-existing Do Not Resuscitate (DNR), Do Not Intubate (DNI), or Comfort Measures Only (CMO) status prior to acute hospitalization
* Neurologically morbid-bound on hospital arrival (bilateral fix/dilated pupils, catastrophic bleed/TBI) and likely to progress to brain death within 48 hrs
Glad Press 'n Seal® as a Temporary Moisture Barrier to Central Lines in Ambulatory Patients

The purpose of this study is to see if Glad Press 'n Seal works as a moisture barrier for central line that is left in place during ambulatory oncology clinical care.

Enrolled subjects will be instructed on the application of the Glad Press 'n Seal product to their IV dressing for use during a shower activity. Practice with application and removal of the product will be supervised by the PI or RA. Questions will be answered and a commercially purchased box of the investigational product will be given to the subject for home use.

Eligibility Criteria:
Inclusion Criteria:

* Subjects requiring mediport or peripherally inserted central venous catheter line access for 3-5 days
* Able to read and write English
* Use showering as a means of home hygiene

Exclusion Criteria:

* Subjects with eczema/psoriasis at the line insertion area
* Subjects with active line/site irritation/infection
* Subjects on chemotherapy protocols including anti-epidermal growth factor receptor drugs (cetuximab, panitumumab) or ipilimumab as there is a high incidence of skin rash as a side effect of these medications
* Patients who do not intend to shower as a means of home hygiene
Legacy for Children, an Early Intervention Study to Promote Optimal Child Development in Low-income Families

The purpose of this study is to determine if an intervention focused on promoting parent-child interaction, parental responsibility, parental commitment of time and energy, and sense of community results in better developmental outcomes for low-income children.

The early years of life (birth to age 5 years) are crucial in a child's development. Parents play a critical role in their children's development and are responsible for the environment in which they grow up. Past research shows that the personal characteristics of successful children consistently correlate to parental influences and behavior. Thus, the theoretical foundation in the Legacy study is that parents can positively influence their child's development. Also, parents are more likely to maintain positive parenting behaviors if they are part of a community greater than themselves. Legacy intervention activities are designed to enhance sensitive and responsive parenting, parent/child interaction, and promote a sense of community. Other activities include verbal and cognitive stimulation through parent and parent/child group meetings, visits to the home, and participation in community events. Legacy has both a pilot phase and a main study phase. There are 180 intervention and 120 comparison families in the main study phase and 60 of each in the pilot phase at each study site, Miami and Los Angeles. The 720 participating families are those whose children, on average, would be expected to fall below national norms on a range of developmental outcomes. Process, cost, and short- and long-term outcome data are being collected.

Comparison group: In addition to the current standard of care, the comparison families receive regular comprehensive child development and maternal assessments at 6 months, 1 yr, 2 yr, 3 yr, 4 yr, and 5 yr.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Live within 10 miles of UCLA
* 18 years of age or older
* Receive their prenatal and well-baby care from MediCal
* Live within 50 minutes of the three community intervention sites
* Reside within zip codes corresponding to the lowest performing schools in the broad Miami area
* Give birth to the target child at participating hospitals

Exclusion Criteria:

* Multiple birth greater than twins
* Existing Substance abuse
* Existing Mental Health issues
DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension

This is a double-blind, active-controlled, long-term study of a new experimental drug called darusentan. Darusentan in not currently approved by the United States Food and Drug Administration (FDA), which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan (optimized dose) as compared to an active control, administered orally.


Eligibility Criteria:
SELECTED INCLUSION CRITERIA:

1. Subjects must be competent to provide written informed consent;
2. Subjects must have completed the Maintenance Period of the DAR-312 study.

SELECTED EXCLUSION CRITERIA:

1. Subjects who discontinue treatment with study drug prior to the end of the Maintenance Period in DAR-312 due to a study drug-related AE;
2. Subjects who experience a study drug-related serious adverse event (SAE) during the DAR-312 study.
Light Therapy in Parkinson's Disease

The aim of this randomized controlled trial (RCT) is to clarify the effect of bright light therapy on motor symptoms and sleep disorders in patients with Parkinson's disease.

As the most important biologic rhythm timer, exogenous light supplement has certain benefits for the improvement of sleep quality and dementia. At present, it is gradually used in sleep and neuropsychiatric diseases. In an open study, 120 patients with PD received 4000 to 6000 lux of light, for 60 minutes before habitual bedtime. The patients were followed up for several months to 8 years, and it found the patients who persisted in the treatment improved their mood, anxiety and motor function. Clinical studies have confirmed the safety and effectiveness of light in improving insomnia and daytime sleepiness of PD patients. It was found that strong light can significantly improve the patients' motor and non-motor symptoms. However, these findings have not been reported in Chinese PD patients. The aim of this randomized controlled trial (RCT) is to clarify the effect of bright light therapy on motor symptoms and sleep disorders in patients with Parkinson's disease and explore the possible mechanism.

Eligibility Criteria:
Inclusion Criteria:

* According to the criteria of PD diagnosis of the MDS, PD patients were selected as the research object. The clinical symptoms of PD patients were consistent with Hoehn and Yahr stages 2-3.
* All PD patients have maintained stable drug treatment for at least one month, signed clinical informed consent and agreed not to adjust drugs throughout the light test and follow-up period.

Exclusion Criteria:

* Using hypnotic or stimulating drugs.
* Using antidepressants, except stable drugs maintained for more than three months;
* Visual impairment, such as cataract, glaucoma, blindness, etc;
* Cognitive impairment (MMSE \< 24);
* There are uncontrollable hallucinations and mental diseases;
* There are sleep phase delay / advance syndrome, shift work, jet lag, etc
A Wrist-Worn Nerve Stimulator for Remediating Persistent Post-Concussive Symptoms in Adolescents

The goal of this study is to test a wearable nerve stimulator in adolescents with persistent post-concussive symptoms. The main questions it aims to answer is whether the device will reduce clinical symptom burden, reduce cognitive deficits, and aid in the recovery of clinical symptoms.

Participants will wear the device daily for six weeks and complete a series of assessments.

The primary aim of this study is to evaluate the effectiveness of the Apollo Neuro Device on remediating clinical symptoms, cognitive deficits and physical symptoms of those patients struggling with persisting post-concussive symptoms. The Apollo Neuro Device offers a convenient novel, non-invasive, non-habit-forming solution to improve performance and recovery under stress by delivering gentle wave-like vibrations to the body that improve autonomic nervous system balance in real time. The investigators will carry out a prospective study including any individual over the age of ten years presenting with persisting post-concussive symptoms. An Apollo Neuro Device will be offered as part of a treatment plan to patients with chronic neurological symptoms and will be used as an adjunct along with typical treatment. Patients will follow-up for a comprehensive evaluation, per discretion of specialty physicians and weekly symptom surveys will also be emailed to patients to track status. The results of this study will further the understanding of autonomic dysfunction symptomology and recovery and evaluate the effect of nerve stimulation as a means of mediating autonomic nervous system dysfunction in these patients.

Eligibility Criteria:
Inclusion Criteria:

* concussion diagnosis
* able to follow simple instruction
* able to sit upright in a chair for at least 30 minutes without rest

Exclusion Criteria:

* previous diagnosis of moderate or severe traumatic brain injury
* neuropsychiatric conditions of schizophrenia or bipolar disorder
* neurophysiological conditions of epilepsy, cerebral palsy, or severe sensory disorders
Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis for Adoption and Adherence for Black Canadians

Aim 1: Adapt Ottawa Decision Support Framework for the HIV PrEP decisional needs of African, Caribbean and Black (ACB) Canadian patients Aim 2. Pilot Test The Adapted Decision-Support Intervention Using a Two-Arm Randomized Controlled Design

Aim 1: Adapt Ottawa Decision Support Framework for the HIV PrEP decisional needs of ACB Canadian patients. Investigators propose a cross-sectional qualitative descriptive study using data collected from key informant interviews with PrEP eligible patients and surveys with health professionals involved in HIV PrEP management. Under this aim two research questions will be investigated.

Q1) What factors do ACB Canadian patients consider when deciding whether to adopt HIV PrEP? Q2. How do SDT constructs of autonomy, competence and relatedness influence ACB Canadian's decision-making experiences regarding PrEP adoption?

AIM 2. Pilot Test The Adapted Decision-Support Intervention Using a Two-Arm Randomized Controlled Design.Hypothesis testing will be de-emphasized in favor of generating effect size estimates. Under this aim three research questions will be investigated. Preliminary hypotheses include:

H1: PrEP decision support increases decision quality in both LDQ and HDQ groups, H2: HDQ + decision-support group more likely to initiate PrEP than HDQ control, H3: HDQ PrEP initiators are more likely than LDQ initiators to have serum levels consistent with adherence at 60-days.

Data on decision quality survey and PrEP initiation data will generated by the subject from self-administered assessments via the decision-support app on the study-issued smartphone. Investigators will also collect biological specimens to measure adherence to HIV PrEP at 60-days post enrollment.

The study will take place in the Toronto metropolitan area (pop. 2.5 million). Over half (59%) of Canada's ACB population is settled in the province of Ontario. Moreover, the majority (70%) of ACB people in Ontario live in metro Toronto, making it the ideal location for this study. The trial procedures will be conducted at sites within the St. Michael's Hospital (SMH) system, including the SMH Li Ka Shing Knowledge Institute.

Eligibility Criteria:
Inclusion Criteria

* Self identify as Black African, Caribbean and or Canadian
* HIV sero-negative
* Not in a monogamous sexual partnership with a recently tested HIV negative man
* Self report unprotected anal sex with a man in the past six months
* Diagnosed with gonorrhea, chlamydia or syphilis in the past six months
* Are in an ongoing sexual relationship with an HIV positive partner
* Currently live in the Greater Toronto metropolitan area
* Can speak and understand either English or French

Exclusion Criteria

* Non Black African Caribbean and or Canadian person
* Diagnosed with HIV and or AIDS
* Unable to consent to provide documentation of negative HIV status
Adaptation of the Uniform Data Set for Telematic Administration

The present project is an evolution of the previous RIN 2019 study aimed at validating and standardizing the Uniform Data Set (UDS) for dementia, a battery of tests exploring various cognitive domains (memory, language, praxis, executive functions) and involving partial tablet-based computerization for data collection.

In the present study, a UDS-based instrument that can be used in remote examiner-assisted telematic administration will be validated. This will be followed by standardization of the same on a sample of healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* female and male subject between 50 and 90 years
* no negative score on the Anamnestic Questionnaire
* internist pathology in pharmacological compensation
* signing of informed consent

Exclusion Criteria:

* neurological pathologies
* decompensated metabolic pathology
* use of Benzodiazepine and psychoactive drugs
Effect of Planter Vibration and Otago Exercise in Old Hemiplegic Patients

This study aims to determine effect of Plantar vibration and Otago exercise on risk of fall and quality of life in hemiplegic elderly

Stroke is one of the major causes of permanent disability. Stroke can have many causes and occurs mainly in old age, Hemiplegic patients have a two-fold higher risk of falling than other patients of the same age or gender, beside fall in older adults can cause significant physical and psychological injury to the individual. Otago exercises are the interventions given for fall prevention in elderly and showed good results with hemiplegic cases as well, it is easy and could be done by old adults even at home. Plantar vibration as a cheap, portable, and easy applicable, saving time and with no effort could be a good choice as a treatment tool to be added for old hemiplegic patients treatment programme. Thus applying an easy and effective programme for old hemiplegic subjects that reduces their risk of fall and improves their balance and ADL and at the same time helps them to conduct it easily and adhere to it should be our target to full fill.

Eligibility Criteria:
Inclusion Criteria:

* first-ever stroke
* age 65-75years
* duration since stroke ≥6 months
* balance deficit confirmed by one leg stance (OLS) test; patient unable to stand on affected leg for 30s with eyes open
* able to walk without the use of aids .able to understand verbal commands.

Exclusion Criteria:

* participation in other treatment protocols for balance
* presence of conditions other than stroke affecting balance
* history of lower-limb surgery within the previous year
* fixed ankle contractures
* cognitive impairments (MMSE\<24)