cyrilzakka/clinical-trials huggingface dataset:
FLO2 for Recovery After SCI

Acute intermittent hypoxia (AIH) involves short (\~1-2min) bouts of breathing low oxygen air to stimulate spinal neuroplasticity. Studies in rodents and humans indicate that AIH improves motor function after spinal cord injury (SCI). This study will use a double blind, cross-over design to test if the combination of AIH and respiratory strength training improves breathing function more than either approach alone in adults with chronic SCI.

Spinal cord injury (SCI) disrupts neural pathways to respiratory motor neurons, causing muscle paralysis and decreased breathing capacity. Since respiratory impairment is the major cause of illness and death with SCI, it is critical to devise new strategies to restore breathing function.

Repetitive exposure to brief episodes of low oxygen (acute intermittent hypoxia or AIH) has demonstrated to increase respiratory function in humans with chronic SCI. Additionally pre-clinical studies demonstrate that AIH-induced functional benefits are enhanced by combining AIH with task-specific training. The investigator's central hypothesis is that combined daily AIH (dAIH) and respiratory strength training will elicit greater and more sustained gains in respiratory function than either treatment alone in people with chronic SCI.

This study is a double-blind, randomized, cross-over design where participants will complete 4 random-ordered blocks, consisting of a 5-day intervention followed by a 3-week washout period, during which 1-day, 3-day, and 1-week post-tests will be conducted. Participants will include 53 adults with chronic, incomplete SCI with \>20% respiratory impairment based on maximal inspiratory or expiratory pressure generation.

Eligibility Criteria:
Inclusion Criteria:

* Chronic incomplete SCI for ≥ 1 year at or below C-1 to T-12
* Incomplete SCI based on residual sensory and motor function below the level of the injury or injury classification of B, C, D at initial screening according to the American Spinal Injury Association Impairment Classification and the International Standards for the Neurological Classification of SCI

-OR-

Chronic complete SCI for ≥ 1 year at or below C-4 to T-12

* Complete SCI based on the absence of residual sensory or motor function below the level of injury or injury classification of A at initial screening according to the American Spinal Injury Association Impairment Classification and the International Standards for the Neurological Classification of SCI.
* Medically stable with clearance from physician
* SCI due to non-progressive etiology
* \>20% impairment in maximal inspiratory or expiratory pressure generation, relative to established normative values.

Exclusion Criteria:

* Current diagnosis of an additional neurologic condition such as multiple sclerosis, Parkinson's disease, stroke, or brain injury
* Presence of unstable or uncontrolled medical conditions such as cardiovascular disease, myocardial infarction, \<1 year lung disease, infections, hypertension, heterotopic ossification.
* Severe neuropathic pain
* Known pregnancy
* Severe recurrent autonomic dysreflexia
* History of seizure disorder \< 1 year
Kinematic Assessment In Multiple Sclerosis

Multiple sclerosis (MS) affects more than a 120,000 people in the United Kingdom and is the commonest neurological condition in young adults. MS causes a number of symptoms including weakness, altered sensation, pain and memory difficulties. There are different forms of MS, including relapsing-remitting MS (RRMS), primary progressive MS (PPMS) and secondary progressive MS (SPMS). Currently there are several effective treatments for RRMS, but no NICE approved treatment for SPMS. Patients with PPMS and SPMS experience a gradual progression in disability that affects individual patients differently. A number of clinical scores are used to quantify the disability in individual patients and some of these scores focus on the patients' lower limb function. In the progressive forms of MS, preservation of upper limb function becomes a more important concern for patients to maintain their quality of life.

With the advent of new treatment trials for PPMS and SPMS, it is important that clinicians and researchers are able to use accurate and quantifiable measures of upper limb function to evaluate any changes with time or response to treatment. The use of motion tracking software provides a unique opportunity to accurately track movements in real time and space and give a tailored assessment of an individual's function.

The overall aim of this study is to use established kinematic assessment tools to explore the extent and progression of upper limb dysfunction in patients with progressive MS. This aim will be achieved via the following objectives:

* Recruit a sample of participants with PPMS and SPMS from the local MS population
* Quantify the physical impairment in these participants using existing clinical scores as well the kinematic assessment tools that have been developed
* Follow-up the participants for a period of 12 months to identify and quantify any progression in their upper limb dysfunction
* Identify any factors that may influence upper limb dysfunction in this group
* Develop and evaluate the role of further kinematic techniques in this group of participants


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years at the time of enrolment into the study
* Participants with a confirmed diagnosis of MS that have entered the primary or secondary progressive stage for at least 12 months
* Participants must be able to comply with the terms and methods of the protocol
* Study specific written informed consent has been obtained

Exclusion Criteria:

* Age below 18 years at the time of enrolment into the study
* Participants with a diagnosis of RRMS
* Participants unable to comply with the terms or methods of the protocol
* Participants who report any cognitive or memory impairment
* Participants with significant co-morbidities that affect their upper limb function i.e. stroke etc.
Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension

A significant number of pregnancies are complicated by hypertensive disorders. Hypertension often worsens in the postpartum period and many women need started on medications. Currently, recommended medications for blood pressure management in pregnant and postpartum women are limited, with labetalol and nifedipine ER being the most commonly used medications. While these medications are both effective, they are not without limitations. Amlodipine is a medication in the same class as nifedipine ER. It is a first-line antihypertensive in the general population. It tends to have less side effects than nifedipine ER. It has not been studied specifically in postpartum women. The purpose of this study is to determine if amlodipine is noninferior to nifedipine ER in managing hypertension in the postpartum period.


Eligibility Criteria:
Inclusion Criteria:

* Postpartum women with a diagnosis of chronic hypertension, gestational hypertension, or preeclampsia
* Delivery at or beyond 20 weeks' gestation
* Need for antihypertensive therapy, defined as blood pressure \>/= 150 mmHg systolic and/or 100 mmHg diastolic on two occasions four hours apart or isolated blood pressure \>160/110 mmHg
* English or Spanish-speaking
* Age 18 years or older

Exclusion Criteria:

* Use of antihypertensive prior to delivery (for any indication)
* Allergy to nifedipine ER or amlodipine
* Persistent tachycardia (as defined by the treatment team)
Effectiveness of the Suboccipital Inhibition Technique in Forward Head Posture.

In this randomized controlled experimental trial, it is aimed to verify the effectiveness of applying the suboccipital inhibition technique in altering forward head posture, increasing the craniovertebral angle and decreasing the angle between the chin, the external acoustic meatus and the sternal angle.

Forward head posture (FHP) is defined as misalignment of the head caused by anterior translation of the head in relation to the trunk, The incidence rate of this postural alteration is 66% in individuals between the ages of 20 and 50.

In order to diagnose this alteration, two angles are used: the craniovertebral angle (CVA) and the angle between the chin, the external acoustic meatus and the sternal angle (AMME), with the CVA being the reference angle for diagnosing a FHP. According to the literature, when the CVA is less than 49.9º, there is a FHP.

We decided to use the suboccipital inhibition technique, which according to Eileen DiGiovanna et al (2005), causes a decrease in muscle tension leading to their relaxation. This relaxation, according to Heredia Rizo et al (2012), has significant effects on increasing CVA, which in turn will decrease AMME, resulting in a positive change in FHP.

Eligibility Criteria:
Inclusion Criteria:

* male and female;
* be over 18 years old;
* have a craniovertebral angle of less than 49.9º.

Exclusion Criteria:

* have a craniovertebral angle greater than 49.9º;
* be a 3rd or 4th year osteopathy student;
* be an osteopath.
Dexpramipexole Renal PK Study

This is a multicenter, open-label, single-dose, PK and safety study in subjects with various stages of renal impairment.

Dexpramipexole (BIIB050, KNS-760704; (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine dihydrochloride monohydrate) is a synthetic amino-benzothiazole. Data from multiple in vitro and in vivo assays have suggested that dexpramipexole is neuroprotective. It is being investigated for the treatment ALS.

As dexpramipexole is principally eliminated from the body by the kidneys a single oral dose of dexpramipexole will be administered to subjects with various stages of renal impariment comprising the following categories: mild, moderate, severe and ESRD subjects. Healthy volunteers will be matched to each catergory of renal impaired subjects.

Eligibility Criteria:
Inclusion Criteria:

* Adult males/females aged 18 to 75 years inclusive and between 19 and 36 kg/m2 inclusive BMI.
* Subjects with renal impairment must have stable renal disease (i.e., no change in disease status within the 28 days prior to dosing) as determined by the Investigator with laboratory and clinical findings that support the diagnosis of renal impairment.
* Subjects with renal impairment (excluding ESRD subjects), must have 2 separate estimates of creatinine clearance that are within 25% of each other, obtained \>5 days apart, but not \>6 months apart
* Subjects must have a GFR (estimated GFR; as defined by estimation of creatinine clearance using the MDRD formula) of ≥80 (healthy volunteers), between 50 and 79 (mild renal impairment), between 30 and 49 (moderate renal impairment), or \<30 (severe renal impairment), or must require dialysis ≤3 times a week (ESRD).
* Healthy volunteers must be matched to renally impaired subjects for age (± 10 years), gender, and if possible BMI (± 20%).

Exclusion Criteria:

* Healthy volunteers who have received prescription medication within the 14 days prior to dosing (except for birth control).
* Renally impaired subjects who have received prescription medication within the 14 days prior to dosing (except for birth control and medications taken at a stable dose for underlying conditions, as determined by the Investigator).
Neurodevelopmental Outcomes of Preterm and Term Children

This study will utilize two validated tools for assessing child development and behavior, to investigate the outcomes for children born preterm compared with those born at full term. Two hundred children born or cared for during the neonatal period at Mount Sinai Hospital will be enrolled. Parents will be asked to complete a behavioral assessment questionnaire, and which will assess development in an examination administered by a trained occupational therapist at Mount Sinai Hospital.

This research will be completed at Mount Sinai Hospital. All participants will be identified from Mount Sinai Hospital records of infants born at MSH and/or cared for in the Mount Sinai NICU on or after January 1, 2011, at full term or preterm. The study team will contact the parents of eligible potential participants by telephone to explain the study and ask if the parent will consent to their child's participation. If the parent agrees, we will make an appointment for the child to come to Mount Sinai for the evaluation using the Bayley-III. The parents will be mailed the study consent form, a fact sheet with information about the study, and the CBCL to complete before they bring their child to their appointment. Mount Sinai records from the birth hospitalization will be reviewed for the birth history and medical comorbidities. Mount Sinai medical records of the mother's obstetric care will also be accessed to obtain medical history from the pregnancy. If a participating child has received outpatient care at Mount Sinai, the investigators will access their record in Epic to obtain scores from previous developmental assessments and records of medical comorbidities. If they have not attended the Mount Sinai clinic, but have received outpatient care elsewhere, the parents will be asked to provide contact information for their pediatrician, and for permission to obtain their child's records.

Eligibility Criteria:
Inclusion Criteria:

* Born on or after January 1, 2011
* Admitted to the Mount Sinai Hospital for newborn care

Exclusion Criteria:

* Non-English speaking
Milk Intervention Study for Brain Aging

The purpose of this study is to learn if increased dairy food consumption helps brain health in older adults by protecting nerve cells from damage.

Eating more dairy foods may improve brain health as people age by increasing the brain's natural defenses to protect nerve cells against chemical stress. Researchers think there may be a relationship between the brain's natural defense system and the amount of dairy food intake. Strengthening these defenses could provide beneficial protection to the brain against neurodegenerative age-related diseases and cognitive decline.

Glutathione (GSH) is a metabolite in the human brain protective system. It plays a key role in protecting cells against oxidative stress, which is one of the major processes contributing to aging and neurodegeneration. Preliminary findings suggest that there may be a correlation between dairy food intake and GSH levels in the aging brain. Magnetic Resonance Spectroscopy (MRS) measures chemicals in the brain. It is a noninvasive measure of the effects of dairy food intake on the major protective metabolite levels in the living human brain in aging.

This study involves using an MRI with special MRS scans to see if adequate dairy food intake may aid in enhancing cerebral protective capacity to fight against age-related disease and cognitive decline in the brain.

Participants will be asked to make a total of six visits to the research site. Participation will last about 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Good general health with no concomitant diseases which could interfere with the study
* Low dairy consumption (≤ 1.5 dairy serving/day)
* Mini-Mental State Exam (MMSE) ≥ 24
* body mass index (BMI) range: 18.5 - 35 kg/m2

Exclusion Criteria:

* Presence of any central neurological diseases or prior major head trauma with loss of consciousness
* Presence of an active unstable and life-threatening systemic illness (e.g., cancer)
* Presence of major psychiatric disorders within the past 3 years including depression, anxiety, and alcohol or drug abuse
* Presence of diabetes mellitus, metabolic syndrome or uncontrolled hypertension
* Use of psychoactive and investigational medications
* Subjects with MRI contraindications such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia.
* Pregnancy
* Special diet regimens such as lactose free or vegan
Comparison of Three Techniques of Nasogastric Tube Insertion Without Instrumentation

This study compares two modified techniques(contralateral cricothyroid pressure and ipsilateral head turning technique) of nasogastric tube insertion in anesthetized and intubated patients with the conventional technique.

The insertion of nasogastric tube in anesthetized, paralysed and intubated unconscious patients may be difficult, with a reported failure rate of nearly 50% on the first attempt, with the head in neutral position there are many different maneuvers to facilitate the insertion of nasogastric tube published.

Our hypothesis is that contralateral cricothyroid pressure to the selected nostril for nasogastric tube insertion will be able to avoid the difficulty.

Therefore we are going to compare this technique with the conventional technique (head in neutral position) with lateral head turning group and contralateral cricothyroid pressure group We hope that the contralateral cricothyroid pressure will increase the success rate, as this will be helpful in intubated patients with neck pathology.

Eligibility Criteria:
Inclusion Criteria:

* patient who is scheduled for elective surgery under general anaesthesia requiring NGT insertion
* aged 20 to 70 years old
* with normal airway (Commack Lehane 1 or 2) and neck movements.

Exclusion Criteria:

* Patient who has nasal stenosis, nasal septal deviation, upper airway deformity, base of skull fracture, oesophageal disorders, coagulopathy, and pregnant.
An Evaluation of a Antimicrobial Stewardship Recommendation Bundle for Staphylococcus Aureus Bloodstream Infections

In July 2020, a bundle (Appendix C) was implemented at Methodist Dallas Medical Center where all patients with SAB were reviewed by the antimicrobial stewardship pharmacist (Monday - Friday from 0700 to 1500), a note outlining optimal interventions was written in the electronic medical record (EMR), and the recommendations were communicated to the primary team via secure messaging or telephone

Evaluation of the Staphylococcus aureus bloodstream infection(SAB)bundle recommendations will allow for determination of whether this intervention is impactful and warrants the resources currently devoted to it.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age SAB during hospital admission

Exclusion Criteria:

* Patients with a history of a prior SAB during the study period (only first occurrence included)
* Blood culture collected within 48hours of patient expiring or transitioning to hospice
* Patients discharged or left before culture results were available
* Patients transferred from an outside hospital
Wellroot PT Versus MTA in Pulpotomy of Primary Molars

compare the clinical and radiographic success of mineral trioxide aggregate (MTA) versus premixed bioceramic paste (Wellroot PT) as pulpotomy medicaments in primary molars.

Preservation of primary dentition decreases the risk of developing any occlusal abnormalities caused by premature loss of primary teeth, which are considered natural space maintainers for the successor permanent teeth, therefore vital pulp therapy is of a big concern in the research field in pediatric dentistry .

One of the most commonly used regenerative materials in pulpotomies is Mineral Trioxide Aggregate (MTA) which showed a high success rate clinically and radiographically when compared to other materials due to its biocompatibility, antibacterial properties and excellent sealing ability . However it has some drawbacks such as difficult manipulation and handling because it is supplied in powder and liquid form which need mixing. Mixing is operator dependant and may be not uniform if handled wrongly, technique sensitive, potential discoloration, and long setting time.

Premixed bioceramics Well-Root™ PT (Vericom, Gangwon-Do, Korea) have been introduced into the market and present with desirable properties as a pulp capping agent. Owing to good handling characteristics, biocompatibility, odontogenic property and antibacterial action, the premixed bioceramic materials are recommended for procedures such as pulp capping, pulpotomy, perforation repair, root-end filling, and obturation.

Eligibility Criteria:
Inclusion Criteria:

* • Children aged between 4 years and 7 years.

  * Mandibular second primary molar with deep caries involving pulp.
  * No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of the vestibule.
  * Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.

Radiographic criteria:

* No sign of radiolucency in periapical or furcation area.
* No widening of PDL space or loss of lamina dura continuity.
* No evidence of internal/external pathologic root resorption.

Exclusion Criteria:

* • Uncooperative children.

  * Children with systemic disease.
  * Lack of informed consent by the child patient's parent.
  * Unable to attend follow-up visits.
  * Refusal of participation.
Bioactive Glass in the Treatment of Enamel White Spot Lesions

the aim of this study is to evaluate the effectiveness of BiominF® and Novamin® in comparison to Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in the treatment of enamel white spot lesions


Eligibility Criteria:
Inclusion Criteria:

* Not less than 1 white spot lesion on the labial surface of teeth in the anterior region with code 2 International Caries Detection and Assessment System II (ICDAS-II) or less
* Absence of any active periodontal disease.
* Written informed consent

Exclusion Criteria:

* Known hypersensitivity/allergy to study products and/or materials used
* teeth having deep carious lesions or extensive restorations
* Unwillingness to be randomly assigned to 1 of the 3 treatment groups
* Advanced periodontal disease.
Tailored Treatment to Enhance Risk Perception in Sleep Apnea

Obstructive Sleep Apnea (OSA) is seen in approximately 6% of Americans. It is a serious medical condition with significant medical and psychological consequences, including diabetes, hypertension, and cardiovascular disease. The treatment of choice for OSA is Positive Airway Pressure therapy (PAP). PAP supplies positive pressure to the upper airway creating a "pneumatic splint" to keep the airway open during sleep. Adherence to PAP is notoriously low, with as few as 50% reaching minimal guidelines for adherence. One comprehensive review of adherence research found that adherence to PAP was less than that for any other medical disorder. The problem of adherence is significant not only because of the medical consequences that can ensue, but also because third party payers have begun to refuse to pay for PAP therapy when adherence is less than optimal, even in the face of clinical improvement. This is a critical time to address this problem.

This research study is designed to identify methods that may help people respond to PAP, the most common therapy for OSA. Identifying these methods may be an important way to better care for patients with obstructive sleep apnea. With this research, the investigators hope to find ways to help people have a better response to treatment and a better quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Polysomnography (PSG) confirmed diagnosis of Obstructive Sleep Apnea (OSA)
* choice of PAP as preferred treatment
* judged by sleep physicians to be responders to PAP
* participants will be considered responders to PAP if they have an AHI of less than 5, do not snore, and have an arousal index of less than 10 when titrated to the proper pressure of PAP

Exclusion Criteria:

* Apnea-Hypopnea Index (AHI) \< 15 on the diagnostic PSG and no daytime functional symptoms or associated cardiovascular disease
* a sleep disorder other than OSA that causes arousals from sleep (e.g., periodic limb movements, restless legs syndrome, insomnia)
* a current substance abuse problem
* a serious sleep-disruptive medical condition (e.g., end stage renal failure, severe Chronic Obstructive Pulmonary Disease (COPD), severe asthma)
* significant global cognitive impairment
* history of or current diagnosis of psychosis, bipolar disorder, or borderline, schizotypal or antisocial personality disorder, and uncontrolled depression or suicidal ideation
* change in antidepressant medications over the past 3 months
* women pregnant women, breast feeding, or planning on becoming pregnant
* currently enrolled in another research study