cyrilzakka/clinical-trials huggingface dataset:
Trial on Oral Appliance Design for Improving Upper Airway Function and Sleep Quality

This study will compare the effectiveness of the two leading oral appliances (OAs) designs for the treatment of severe obstructive sleep apnea in overweight adults. The effectiveness of OAs has come under question since different designs are combined in evaluating treatment efficacy, for example when comparing them to continuous positive airway pressure Due to the wide range of reported efficacy (53 to 90%), it is of great value to identify the most effective design to guide sleep practitioners and patients.

The two prominent oral appliances used in treating obstructive sleep apnea differ in their designs, mid-line traction versus bilateral thrust. From a clinical perspective, it is important to know which design is superior and should be the 'treatment of choice' for improving airway function and sleep quality. These two designs differ in their protrusive mechanisms that are categorized in general under four main types: bilateral compression, bilateral thrust, midline compression and mid-line traction. Although the two designs considered in this proposal have undergone the most rigorous testing individually, well controlled 'head-to-head' trials as proposed here have not been conducted to determine their efficacy within a single test population.

Eligibility Criteria:
Inclusion Criteria:

* OSA PSG or PG diagnosed adults within 1 year
* age \>18
* Currently treated with continuous positive airway pressure (CPAP)
* AHI ≥ \>30 events/hour of sleep
* Two or more OSA symptoms (snoring, witnessed apnea or daytime hypersomnolence complaint)
* BMI ≥ 30
* At least 8 teeth per arch to support either OA device
* Central and mixed apnea index \<5 events/hour
* Mallampati score from I to III
* Palatine tonsils - grade 0, 1, or 2
* Consent to study's timeline
* Willingness to wear home sleep test apparatus for at least 4 nights
* Willingness to wear an oral appliance every night for 8 weeks
* Willingness to pick up and return home sleep test kits as needed

Exclusion Criteria:

* Cardiac \& pulmonary disease (e.g., congestive heart failure, severe arrhythmias, COPD);
* Central sleep apnea;
* Comorbidities with other sleep disorders
* No active TMD or jaw muscle pain
* Morphological airway abnormalities
* Pre-existing difficulty swallowing; throat or neck related health issues
* Endocrine dysfunction
* Severe psychiatric disorders;
* Previous OA therapy; ENT surgery
* Restrictions in jaw opening
* Pregnancy / breast feeding or intent to become pregnant during the study
* Inability to apply the sleep recorders
Impact of Therapeutic Plasma Exchange on RNA Biomarker Expression Levels in Alzheimer's Patients

The study will determine if Therapeutic Plasma Exchange removes RNA biomarkers associated with Alzheimer's Disease and how quickly those biomarkers reappear after treatment.

Participants with a diagnosis of Alzheimer's or Mild Cognitive Impairment will undergo therapeutic plasma exchange as part of their treatment for the disease as per the AMBAR Trial protocol. Patients will undergo one non-invasive tests to assess their microvascular system and complete one online test to assess the degree of cognitive impairment. Patients will have their blood drawn pre-plasma exchange, immediately post plasma exchange and repeated assessments and blood draws at seven day intervals post plasma exchange ending on the twenty-eighth day after the plasma exchange.

Their blood will be analyzed by FBB Biomed to identify the presence of unique RNA biomarkers associated with Alzheimer's disease and determine how quickly they regenerate.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is scheduled to undergo their first TPE Procedure for a diagnosis of Alzheimer's Disease or previous mental/cognitive impairment
2. Mentally capable of understanding and completing informed consent for the study.

Exclusion Criteria:

1. Subject is unable or failed to return/provide blood specimen on days seven (7), fourteen (14) , twenty-one (21), and twenty-eight (28) (plus or minus 1 day on follow up draws) post plasma exchange
2. Subject is unable to provide informed consent.
Metal-on-metal Hip Replacement MRI Study

This study is being conducted to determine the rate of symptomatic and asymptomatic nonmalignant, noninfective soft tissue mass presence (referred to in the literature as pseudotumour, ALVAL, ARMD, cysts or lesions) in primary metal on metal hip replacement patients. The primary objective of the study is to determine the prevalence of masses in unbiased Metal on Metal (MoM) samples drawn from one study centre. The subjects receiving the Metal on Metal devices will be observed at two specific time points. Secondary objectives are to evaluate whether the occurrence of masses is related to any of several potential factors including patient and implant characteristics and time since the implant procedure took place.


Eligibility Criteria:
Inclusion Criteria:

• Patients implanted with the M2a Magnum who were evaluated via MRI and metal ion analysis between 2012 and 2013.

Exclusion Criteria:

* If the primary device was implanted for less than 36 months (in the case of patients already revised) or has been in place for less than 36 months (in the case of patients with the device still in place).
* If the patient is contraindicated for any of the diagnostic tests.
* If the patient fails to consent to participating in the study.
The Effectivness of FODMAP Diet in Israel in Relieving Symptoms of Patients With Irritable Bowel Syndrome

Treatment of IBS is very problematic. Despite the wide range of pharmacological and non-pharmacological therapies, there is no universally accepted approach. In recent years, the low FODMAP diet has been developed, a dietary approach that aims to relieve the symptoms of IBS. FODMAPs (Fermentable Oligosaccharides, Di-saccharides, Mono-saccharides and Polyols) are a group of dietary sugars that may be poorly absorbed in the small intestine and fermented by bacteria to produce gas. Ingestion of FODMAPs may also result in alterations in fluid content in the colon and trigger functional gut symptoms in some individuals. This study aims to examine the effectiveness of the FODMAP diet in Israel in improving symptoms of IBS compared to the standard dietary advice.


Eligibility Criteria:
Inclusion Criteria:

1. Fulfillment of the Rome III criteria for IBS.
2. Aged 18-77 years at the time of screening.
3. Provision of written informed consent.
4. Commitment of availability throughout the 10 week study period.
5. Availability of at least one GI imaging study during the last 5 years (colonoscopy, sigmoidosopy, abdominal ultrasonography, barium enema) for subjects older than 50 years.

Exclusion Criteria:

1. Major abdominal surgery in the past.
2. The presence of any active (organic) GI disease.
3. Past or present major medical or psychiatric illness.
4. Any concomitant disease.
5. Alarming symptoms (rectal bleeding, weight loss, etc.)
6. Pregnancy.
7. Family history of colorectal carcinoma or IBD, under the age of 50.
8. Abnormal laboratory studies (blood biochemistry, liver enzymes, complete blood count), abnormal thyroid function.
9. Non-adjusted diet in the case of lactose or gluten intolerance.
10. Recent travel to regions with endemic parasitic diseases.
Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's Disease

The aim of the study is to assess the effect of continuous levodopa infusion on autonomic nervous system in patients with Parkinson's Disease (PD), blood pressure regulation and sweating. The investigators' hypothesis is that levodopa infusion may alleviate hyperhidrosis and orthostatic hypotension.

Parkinson's disease (PD) is one of the most common neurodegenerative disorders with increasing prevalence because of aging population. The main symptoms include rigidity, hypokinesia, tremor and impaired balance, but the disease also causes autonomic dysfunction. Motor fluctuations are common treatment related problems in PD, around 50-70% of patients treated with levodopa finally develop motor fluctuations. Continuous duodenal levodopa infusion has been effective in the treatment of motor dysfunction in advanced PD. However, little is known of its effects on autonomic nervous system.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease: diagnosis made at least five years earlier
* Positive response to levodopa
* Motor fluctuations that cannot be adequately controlled with oral medication
* No signs or symptoms of cerebellar dysfunction or vascular parkinsonism

Exclusion Criteria:

* Severe cognitive symptoms
* Glaucoma
* Severe arrythmias
* Severe asthma or COPD
* Heart, liver or kidney failure
* No significant vascular lesions in brain MRI imaging.
Study of Adaptive Radiotherapy for High-grade Glioma Based on Interfraction MRI

The changes of target and organs at risk in patients with high-grade glioma during concurrent chemoradiotherapy were evaluated by MRI image between radiotherapy fractions.

To prospectively evaluate the changes of target organs and risk organs in patients with high-grade glioma during concurrent chemoradiotherapy.The related factors causing this change are discussed.The relationship between changes and patient survival was analyzed.A predictive model was established to provide individualized adaptive radiotherapy for patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old;
2. High-grade glioma was confirmed by pathology after surgery;
3. ECOG score 0-2 points;
4. Receiving the standard STUPP regimen (i.e. 6 weeks of temozolomide concurrent chemoradiotherapy +6 cycles of temozolomide adjuvant chemotherapy);
5. Baseline data available.

Exclusion Criteria:

1. The pathological diagnosis is not clear;
2. No synchronous chemotherapy/adjuvant chemotherapy \&amp;lt; 6 cycles;
3. There are other malignant tumors;
4. Previously radiotherapy to the head;
5. Interruption of radiotherapy for more than 5 days;
6. Failure to collect baseline data.
The Effects of Tourniquet Use in Total Knee Arthroplasty

Tourniquets are still widely used in total knee arthroplasty, but are associated with several adverse effects. Most of previous studies did not randomize the participants so the baseline difference of the patients might have influenced the outcome. Therefore, investigators conducted a randomized controlled trial, in which all the patients received staged bilateral TKA with two different durations of tourniquet use. Investigators aimed to quantify the effect of tourniquet use on reducing blood loss and to evaluate the impact of tourniquet use on functional and clinical outcome.

Fifty participants who underwent staged bilateral TKA were recruited in this study. On one side, the tourniquet was inflated immediately before incision and deflated after the hardening of the cement. On the other side the tourniquet was inflated immediately before cement application and deflated after its hardening. Blood loss, operating time, transfusion rate, postoperative pain, limb swelling, deep vein thrombosis (DVT) incidence and clinical outcomes were monitored for comparison.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 50 years or over
* classified as American Society of Anesthesiologists ASA 1-2.

Exclusion Criteria:

* coagulopathy,
* uncontrolled hypertension,
* peripheral vascular disease and
* patients with BMI≥35
Continuous Positive Airway Pressure and Oxygen Concentration on Measurement of Rapid Shallow Breathing Index

To compare the rapid shallow breathing index (RSBI) values, the incidence of adverse reactions, and the predictive accuracy measured under 5 different ventilator strategies in the same patient group.

98 ready for weaning patients were included and divided into success (n=71) and failure (n=27) groups based upon their weaning outcome. Before weaning, the RSBI values were determined under the patients disconnecting from the ventilator (RA-no ventilator) and still connecting to the ventilator with 4 different settings (fraction of inspired oxygen (FiO2) 21 or 40% combined with continuous positive airway pressure (CPAP) 0 or 5 cm H2O). The patients were extubated after completing the weaning trials. Successful weaning was defined as patients free from the ventilator for over 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* intubated medical patients with mechanically ventilated more than 48 hours
* clinically ready for weaning
* Glasgow coma scales were at least 8
* their ventilator settings were: assist-controlled, pressure support (PS)or synchronized intermittent mandatory ventilation plus PS mode, FiO2 40% or less, positive end-expiratory pressure 5 cm H2O or less, and sensitivity setting on 1 L/min. Their arterial blood gases results were acceptable

Exclusion Criteria:

* having ongoing lung or neuromuscular disease and signs of increased intracranial pressure
Safety and Performance of a New Coating for Urinary Intermittent Catheters

The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent and signed letter of authority
2. Be at least 18 years of age and have full legal capacity
3. Be a male
4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits

Exclusion Criteria:

1. Abnormalities, diseases or surgical procedures performed in the lower urinary tract
2. Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
3. Participating in other interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period)
4. Known hypersensitivity toward any of the test products -
Targeting Gut Microbiota and Metabolites for Very Preterm Infants Through Oropharyngeal Administration of Colostrum

Background: Oropharyngeal administration of colostrum (OAC) has an immune stimulating effect on oropharyngeal-associated lymphoid tissue, and can also promote the maturation of the gastrointestinal tract. However, how OAC promotes intestinal maturation in preterm infants by altering the gut microbiota remains unclear. We aim to assess the changes of gut microbiota and metabolites after OAC in very preterm infants.

Methods: A multicenter, double-blind, randomized controlled trial will be conducted in 3 large NICUs in Shenzhen, China, for preterm infants with gestational age less than 32 weeks and birth weight less than 1500g. The intervention group will be given 0.2ml colostrum for oropharyngeal administration every 3 hours, which will start between the first 48 to 72 hours and continue for 5 consecutive days; The control group will be given sterile water for oropharyngeal administration, and the administration scheme will be the same as above. Stool samples will be collected at the first defecation and the 7th day after birth. It is estimated that 320 preterm infants will participate in the study within 1 year. 16sRNA gene sequencing and liquid chromatography-mass spectrometry will be used to analyze the effect of OAC on gut microbiota and metabolites.

Discussion: The proposal advocates for the promotion of OAC as a safe and relatively beneficial initiative among neonatal intensive care units, and this initiative may contribute to the establishment of a dominant intestinal flora. Findings of this study may help to improve the health outcomes of preterm infants by constructing targeted gut microbiota in future studies.

Preterm infants with gestational age \< 32 weeks and weight \< 1500g will be evaluated. Infants who met the inclusion criteria will be randomly divided into two groups according to the ratio of 1:1. The intervention group will be given oropharyngeal colostrum every 3 hours for 5 days; the control group will be given sterile water with the same dosage and administration scheme. Stool samples will be collected at the first defecation and the 7th day to detect the gut microbiota and metabolites.

Eligibility Criteria:
Inclusion criteria:

* gestational age less than 32 weeks and birth weight less than 1500g;
* admission to NICU ≤ 24 hours;
* be able to start the agreement within 72 hours of birth.

Exclusion criteria:

* birth asphyxia (defined as umbilical artery / first hour arterial PH \< 7.0 or cardiopulmonary resuscitation in the delivery room);
* birth complicated with severe gastrointestinal malformations (such as intestinal atresia, esophago-tracheal fistula, intestinal rotation abnormalities, congenital megacolon);
* prenatal diagnosis of congenital chromosomal abnormalities or suspected congenital genetic metabolic diseases;
* maternal drug abuse or contraindications to breastfeeding (HIV and cytomegalovirus infection).
Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3)

Cancer patients with brain metastases (BM) have poor prognosis. Current treatments produce limited efficacy. Recent advance in cancer immunotherapy has provided important new means to treat cancer patients at advanced stages. This study is designed to perform a clinical trial to treat advanced caner patients with brain metastases with personalized dendritic cell-based cellular vaccines. The patients will receive vaccines consisting of mRNA tumor antigen pulsed DCs. Immune response to the immunized tumor antigens will be monitored. Safety and efficacy will be observed in this study.

This is an open label, single-arm, single-institution, Phase I study designed to investigate the safety and efficacy of personalized cellular tumor vaccines for cancer patients with brain metastases (BM). BM patients will undergo tumor resection or biopsy and the tumor tissues will be analyzed for the expression of tumor antigens and immune-related genes. The patients will be immunized with DCs pulsed with mRNA encoded tumor antigens. Patients will be immunized with DC vaccines on a biweekly basis. Safety and efficacy will be monitored. The objective of this study is to assess the safety of the personalized cellular vaccines and to deterimine the antitumor specific T cell responses. The efficacy of the vaccines will be determined using RANO-BM criteria, progression-free survival and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Solid tumor with brain metastases.
* Patients at the age of 18-65.
* Patients undergo tumor resection or biopsy.
* Patients with Karnofsky scores \> or =70
* Patients with normal range of hematologic and metabolic test results.
* Patients must have no corticosteroids treatment at least one week before vaccination.
* Patients capable of understanding the study and signed informed consent.

Exclusion Criteria:

* Infectious diseases HIV, HBV, HCV.
* Documented immunodeficiency.
* Documented autoimmune disease.
* Breast feeding females.
* Pregnant women.
* Any serious or uncontrolled medical or psychiatric conditions, for example, severe pulmonary, cardiac or other systemic disease.
* Patient inability to participate as determined by PI discretion.
Pain in Individuals With COPD During Pulmonary Rehabilitation

This study is aimed at determining the role of pain in individuals with chronic obstructive pulmonary disease (COPD) who are enrolled in a pulmonary rehabilitation (PR) program. It is not known whether pain interferes with an individuals performance in PR, or whether PR aggravates or relieves pain. Individuals with COPD who report chronic pain and those without pain will be enrolled in the study.

Chronic obstructive pulmonary disease (COPD) is a systemic disease associated with dyspnea, fatigue, and poor health-related quality of life. COPD is further complicated by the presence of pain which may be attributed to common comorbidities such as musculoskeletal conditions (osteoarthritis, osteoporosis), cardiac disease or diabetes. Pulmonary rehabilitation (PR) is the cornerstone of treatment for COPD however the impact of pain on PR has not been explored. It is unclear whether those experiencing chronic pain achieve a similar, lesser or greater degree of benefit compared to those without pain, or whether exercise training exacerbates symptoms. Gaining a greater understanding of the effects of an outpatient PR program on pain will provide direction into future specific treatment options which may necessary for managing chronic pain as part of PR.

Individuals with COPD who are beginning an out-patient PR program will be enrolled in the study. Those who report the presence of chronic pain will be classed as the pain group; those who report the absence of chronic pain will be classed as the comparator group. All participants will complete a 6-minute walk test and a Chronic Respiratory Disease Questionnaire (CRDQ) at the beginning of the PR program. These measures will be repeated at the end of the 8-week PR program for all participants. All participants will be asked to report their level of pain using a visual analogue scale every two weeks during the PR program.

Participants reporting chronic pain will also complete a series of questionnaires regarding their pain and coping strategies. These include; the Brief Pain Inventory (BPI), Coping Strategies Questionnaire (CSQ), Fear Avoidance Behavior Questionnaire (FABQ), Hospital Anxiety and Depression Scale (HADS) and Centre for Epidemiological Studies for Depression Survey (CES-D).

Eligibility Criteria:
Inclusion Criteria:

* individuals with moderate to severe COPD based on international (GOLD) criteria
* clinically stable
* no history of acute exacerbation in the past 6 weeks
* able to provide their own informed consent
* referred to out-patient pulmonary rehabilitation at West Park Healthcare Centre

Exclusion Criteria:

* primary diagnosis other than COPD
* known cognitive impairment that would interfere with completing surveys
* cardiac, neurological or orthopedic conditions which prevent the ability to undertake exercise safely
Virtual Mindfulness Rounds in the Time of COVID-19 Pandemic

Mindfulness education will be provided via a virtual platform to see if staff stress can be decreased during this time of pandemic.

Healthcare workers have been front and center in battling the COVID crisis. This is a situation the researchers could never have envisioned before it happened. Of course, this has triggered an inordinate amount of stress. Research shows that chronic stress leaves one imbalanced and one's health and happiness to suffer. Research has also demonstrated that how one thinks about stress determines how the body responds to it. Simple mindfulness practices provide healthier ways to deal with stress. In this study, the researchers will introduce modified mindfulness practices that can be practiced in the healthcare setting or at home. All of the practices are based on mindfulness principles. Mindfulness refers to a state of being present in the moment, on purpose, and without judgment. "Mindfulness Based Stress Reduction" is an 8 week, 2 hours/week curriculum that has shown results for over 40 years. All the practices in this study are adapted from that protocol.

The intervention includes several mindfulness practices including an awareness of breath focus instruction, breath-and-body coordination and awareness instruction, and instruction in identifying times to practice these exercises. The intervention will be delivered virtually 2-day/week, twice/day, for four weeks.

Effectiveness will be measured by the voluntary, anonymous submission of a Perceived Stress Scale, a validated survey tool to determine an individual's perceived stress level.

Participants will be healthcare workers and hospital staff in the Mount Sinai Hospital system.

Eligibility Criteria:
Inclusion Criteria:

* Mount Sinai Hospital employee

Exclusion Criteria:

* None