cyrilzakka/clinical-trials huggingface dataset:
Collaborative Home Visits to Reduce Hospital Readmissions and Improve Medication Use During Transitions of Care

The primary objective is to develop a sustainable practice model emphasizing home visits by a collaborative physician and pharmacist team to decrease unplanned emergency department visits and hospital readmissions at 30 and 90 days for high-risk home bound patients. Secondary objectives include (1) tracking the number, type, and severity of adverse drug events (ADE) and potential adverse drug events (pADE) that occur following hospital discharge and (2) resolving any identified ADE and pADE within 7 days of hospital discharge.

Adult patients will be scheduled for a home visit by the Healthy at Home Columbus program at the time of hospital discharge. The home visit will occur within 7 days of hospital discharge and will consist of a complete hospital and medication review by a physician or nurse practitioner and a pharmacist (including all lab tests, imaging studies, medication changes, and proposed plan of care at the time of discharge). The investigators hypothesize these home visits will reduce 30 and 90 days hospital readmission rates and ED visits.

The number of emergency department visits and unplanned hospital readmissions will be tracked at 30 and 90 days following discharge from the hospitalization that led to study enrollment. A comparison cohort of patients discharged in the 12 months prior to study initiation will be used to compare the effectiveness of the home visit program. The number and type of adverse drug events (ADE) and potential adverse drug events (pADE) that occur during transitions of care will also be characterized. All ADE and pADE will be resolved during the initial home visit and will be classified based on severity. All ADE and pADE will be evaluated independently by two pharmacist reviewers; each reviewer will independently assign a severity rating to each ADE and pADE.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients discharged from the hospital in the last 7 days and with more than two chronic conditions and significant obstacles to accessing care in an office setting are eligible for study participation

Exclusion Criteria:

* Adult patients able to access care in an office setting.
* Adult patients discharged from the hospital greater than 7 days prior to the office visit.
The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children

The study comprises an open-label randomized controlled trial investigating the efficacy of consuming a daily ration of pro-vitamin A biofortified cassava on vitamin A status of Nigerian children, aged 3-4 years old (n=200).

Objective: The primary objective is to assess the efficacy of daily consumption of pro-vitamin A rich cassava during 10 weeks on body retinol pools of 3-4 year old children in Nigeria after high-dose vitamin A supplementation. The secondary objectives are: 1) To investigate the effect of daily consumption of pro-vitamin A rich cassava on functional indicators such as nutritional anaemia and gut integrity; 2) To investigate the effect of zinc deficiency and genetic polymorphisms in the Beta-Carotene Oxygenase 1 (BCO1) and related genes on the efficacy of pro-vitamin A rich cassava consumption; 3) To compare the skin colour in the palm of the hand of each participant with their serum retinol levels using a handheld non-invasive spectrophotometer.

Study design: Open-label (single-blinded) randomized controlled trial with two parallel groups Study population: Pre-school children, aged 3-4 years living in Osun State area, South-Western Nigeria. Children (n=750) will be screened for eligibility. Out of these, n=250 will undergo a 4-week run-in phase. n=200 children will be randomly allocated to two different treatments: 1) Yellow cassava providing \~50% of the recommended daily allowance (RDA) for vitamin A; 2) White cassava.

Main study parameters/endpoints: The primary outcome was the difference in body retinol pools between groups 1 and 2 at the end of intervention; however, due to the inability to assess body retinol pools, the modified primary outcome is the difference in serum retinol concentrations between groups 1 and 2. Other outcome measures include: other vitamin A status indicators (β-carotene, retinol binding protein, transthyretin), inflammatory markers, iron status indicators, anthropometrics, gut integrity, and thyroid function.

Eligibility Criteria:
Inclusion Criteria:

* Aged 36 - 59 months (verified by birth certificates, vaccination cards or other formal documentation)
* Apparently healthy
* Parental informed consent

Exclusion Criteria:

* Frequently absent (\>20% of feeding days) during run-in
* Children not assenting during blood collections
* Signs or history of infectious or systemic diseases (e.g. tuberculosis, sickle cell anaemia)
* Mental status that is incompatible with the proper conduct of the study
* Current participation in other research
* Food allergy related to the intervention foods
Study of Bimonthly VEGF Trap-Eye Compared to As-needed Administration or Other Therapy for Exudative Age-Related Macular Degeneration

Over the last several years, the standard of care for wet macular degeneration has become treatment with intravitreal injections of ranibizumab (Lucentis, Genentech), administered as frequently as every 4 weeks. In contrast, clinical trials of a soluble VEGF receptor, Aflibercept/VEGF Trap-Eye (Eylea, Regeneron Pharmaceuticals) have demonstrated maintained anatomic and visual improvement with many fewer injections (typically monthly injections for 3 months, followed by every-other-month injections, and as few as 5 injections a year). The purpose of this study is to determine whether patients who have switched from ranibizumab to VEGF Trap-Eye have comparable results.


Eligibility Criteria:
Inclusion Criteria:

1. Patients older than the age of 50 determined by a retinal physician at the Byers Eye Institute at Stanford to have exudative AMD requiring treatment.
2. Patients with an established diagnosis of exudative AMD who have been maintained on a regimen of intravitreal ranibizumab injections.
3. Postmenopausal or negative pregnancy test
4. Patients with an established diagnois of exidative AMD who have been switched from intravitreal ranibizumab to intravitreal VEGF Trap-EYE.

Exclusion Criteria:

1. Patients with any previous or concurrent history of treatment of other retinal diseases with pharmacologic agents other than ranibizumab, including verteporfin photodynamic therapy, bevacizumab, triamcinolone, or dexamethasone.
2. Patients with prior history of vitrectomy surgery in the study eye.
3. Patients enrolled in any previous or current clinical trial or study of any medication for AMD or any other retinal vascular disease, including diabetic retinopathy or retinal vein occlusion.
4. Ocular media opacity precluding proper retinal imaging
5. Inadequate pupillary dilation to achieve proper retinal imaging
6. Concurrent use of systemic anti-VEGF agents
7. CNV due to other causes, including histoplasmosis, uveitis, trauma, or myopia
8. Active or recent (\< 4 weeks) or recurrent inflammation in the eye
9. Current vitreous hemorrhage in the study eye limiting visualization of the fundus
10. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
11. Untreated glaucoma with IOP \> 25 in the eye
12. Other ocular diseases that can compromise the visual acuity of the study eye such as amblyopia and anterior ischemic optic neuropathy
13. Pregnancy or lactation
14. History of other disease, exam finding, or clinical laboratory that contraindicates the use the drug
15. Current treatment for active systemic infection
16. Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, pulmonary, renal, hepatic, endocrine, or GI disorders
17. History of recurrent significant infections or bacterial infections
18. Inability to comply with study or follow-up procedure
Dartmouth Middle Meningeal Embolization Trial (DaMMET)

Chronic subdural hematomas (cSDH) are one form of bleeding in the head. They are one of the most common diseases encountered by neurosurgeons across the country. The cSDH can push on the brain and produce symptoms that include seizures, weakness, loss of sensation, and confusion. Many of these cSDH produce repetitive bleeding.

Treatment has largely consisted of surgical drainage of hematoma (also known as a blood clot) through either a small hole in the skull or open surgery. However, it is common for the cSDH to reappear despite these procedures. A recent study has shown a treatment failure rate of 27% and a need for additional surgery at 19%.

A new approach to treatment of cSDH blocks the blood supply to the tissue that produces the repeated bleeding. Catheters are used to gain access to the middle meningeal artery (MMA), an artery that supplies the coverings of the brain. The artery is blocked using small particles or glue in a process called embolization. A recent pilot study of 72 patients who underwent MMA embolization showed a much lower rate of repeated bleeding. Based on these results, it is thought that this procedure holds promise in reducing the number of cSDH that require one or more operations. The goal of this study is to systematically examine if blocking the blood supply to the tissue responsible for repeated bleeding helps the cSDH resolve and improves patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Have radiographic imaging showing a cSDH \> 7mm in maximal thickness encompassing \> 50% of the convexity (non-focal).
* Capable of giving consent for the procedure or have an acceptable surrogate capable of giving consent on the subject's behalf

Exclusion Criteria:

* The cSDH is secondary to an underlying vascular malformation, tumor, cyst, spontaneous cerebrospinal fluid hypotension or previous craniotomy
* Life expectancy \< 6 months
* Vascular anatomy that puts the patient at high risk for adverse events (e.g. critical carotid stenosis, abnormal external-internal carotid circulation)
* Incapable of being reasonably expected to be able to attend follow-up appointments at Dartmouth-Hitchcock Medical Center
* Vulnerable patients including homeless patients, incarcerated patients and mentally ill patients without appropriate medical decision-making proxy that the physician believes are incapable of appropriately assessing the risks of the procedure
Safety and Dose Ranging Study of Insulin Receptor MAb-IDUA Fusion Protein in Patients With MPS I

AGT-181 is a fusion protein containing alpha-L-Iduronidase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously. This study is a safety and dose ranging study to obtain safety and exposure data, as well as information on the biological activity of the investigational drug.


Eligibility Criteria:
Inclusion Criteria:

* Male age 18 years or older
* Diagnosis of MPS I (documented fibroblast or leukocyte IDUA enzyme activity level of less than 10% of the lower limit of the normal range of the measuring laboratory)
* Voluntary written consent by patient or legally responsible representative
* All women of childbearing potential and sexually mature males must be advised to use a medically accepted method of contraception throughout the study.
* Negative pregnancy test (females)
* Must not have received ERT for at least 6 weeks prior to AGT-181 treatment
* Must have elevated urinary GAGs if no ERT has been received in the prior 3 months

Exclusion Criteria:

* Refusal to complete baseline evaluations.
* Any medical condition or other circumstances that may significantly interfere with study compliance
* Receipt of an investigational drug within the prior 90 days
* History of diabetes mellitus or hypoglycemia
* Clinically significant spinal cord compression, evidence of cervical instability.
* Known hypersensitivity to alpha-L-iduronidase or any of the components of AGT-181.
* Known to be nonresponsive to standard ERT treatment.
* Previously successful (engrafted) hematopoietic stem cell transplantation that resulted in normalization of urinary GAGs.
* Contraindication for lumbar puncture
Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a LCD Stent

Internal biliary drainage is an useful method for a control of jaundice and cholangitis to patients who had a malignant hilar obstruction due to hepatocellular carcinoma, cholangiocarcinoma, gall bladder cancer or metastatic lymphadenopathy.

Bilateral biliary drainage is more physiologic but technically difficult to compared with unilateral biliary drainage specially related to conformability and flexibility between using stents.

There are no prospective clinical trials compared with these internal biliary drainage methods in hilar malignant obstruction using metal stent.

Therefore, the investigators want to compare the clinical outcome of two method: Unilateral biliary stent and Bilateral biliary stent


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18
* diagnosis of malignancy in pathology or cytology
* jaundice(Total bilirubin)\> 2.0 mg/dL
* Diagnosed malignant hilar invasion to CT or other image finding

Exclusion Criteria:

* bleeding tendency(INR\>1.5)
* Pregnancy
* severe liver,kidney disease
Comparison of Balance and Fall Risk in Unilateral and Bilateral Total Knee Arthroplasty

Static or dynamic postural control cannot be fully restored in patients with Total Knee Arthroplasty (TKA). Moreover, deficits in balance and postural control may still be present in both extremity after TKA. However, the contralateral knee OA grade, asymmetrical gait pattern, and postural sways still remain a risk factor for balance deficits and falls. Based on this rationale, the aim of this study is to evaluate the balance and fall risk before and after TKA in patients who suffered from bilateral knee osteoarthritis and to clarify the balance and fall risk difference between unilateral and bilateral TKA patients.

Falls are one of the leading causes of increased morbidity and mortality in the elderly population and are substantial contributor to increase healthcare cost burden. Pain, strength deficits, knee joint deformities, balance and proprioceptive impairments associated with severe knee OA, contribute to an increased risk of falling among elderly, and more than 50% of this population experience a fall each year. Static or dynamic postural control cannot be fully restored in patients with Total Knee Arthroplasty (TKA). Moreover, deficits in balance and postural control may still be present in both extremity after TKA. Increased weight-bearing on the operative side after TKA and reduced weight-bearing weight in the contralateral osteoarthritic knee can reduce pain and improve balance-related functions. However, the contralateral knee OA grade, asymmetrical gait pattern, and postural sways still remain a risk factor for balance deficits and falls. Based on this rationale, the aim of this study is to evaluate the balance and fall risk before and after TKA in patients who suffered from bilateral knee osteoarthritis and to clarify the balance and fall risk difference between unilateral and bilateral TKA patients.

Eligibility Criteria:
Inclusion Criteria:

* age between 55 to 85 years, patients with bilateral osteoarthritis, Kellgren-Lawrence grade 3-4, patients capable of understanding verbal and written instructions.

Exclusion Criteria:

* revision TKA surgery, American Society of Anesthesiologists score \>3, neurologic compromise, psychiatric problems, regular hypnotic and/or anxiolytic medication usage, dementia.
Effect of Captopril on GLS in Duchenne Myodystrophy

To outline the intermediate term effect of prescribing Captopril as an add on therapy on Left ventricular functions as measured by Global longitudinal strain in patients with Duchenne myodystrophy (DMD)

ACEI slowing down the onset and the progression of dystrophinopathic cardiomyopathy.

To outline the intermediate term effect of prescribing Captopril as an add on therapy on Left ventricular functions as measured by Global longitudinal strain in patients with Duchenne myodystrophy (DMD

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed Duchenne myodystrophy (DMD) patients with abnormal GLS \< -18% with minimum age of 6 years old.

Exclusion Criteria:

* Any patient who refuses to sign an informed consent.
* Contraindication to ACEI: hypersensitivity - renal impairment - bilateral renal artery stenosis - aortic valve stenosis - hyperkalemia - hypotension.
* Reduced ejection fraction below 50%.
Comparison of Concussion Education Programs

Importance: Concussion underreporting leads to delays in diagnosis and treatment, resulting in prolonged recovery. Athletes' report of concussion symptoms is therefore an important component of risk reduction. Numerous educational interventions to improve concussion knowledge and reporting exist.

Objective: Evaluate the comparative efficacy of three concussion education programs in improving concussion-reporting intention.

Design: Randomized clinical trial conducted from August 2018 to October 2018, with assessment before, immediately after, and one-month after educational intervention.


Eligibility Criteria:
Inclusion:

* Athletes from three high school football teams in California.
* In attendance for practice on both study dates
* Provided signed assent and parental consent.

Exclusion:

* Did not complete more than 50% of the questionnaire.
A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System

This study is a prospective, multi-center registry of patients with intracranial aneurysms who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months post-procedure for the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Intracranial aneurysms \>2mm, ruptured or unruptured

Exclusion Criteria:

* Fusiform aneurysms
* Dissecting aneurysms
* Aneurysms associated with brain AVMs
* Multiple aneurysms
* Re-treated aneurysms
* Patients in whom endovascular embolization therapies other than PC 400 System are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable.
Effects of Urocortins on Forearm Arterial Blood Flow in Healthy Volunteers (Protocol 2)

Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem with a poor prognosis and the search for novel treatments remains an important area of research.

Urocortins are proteins that appear to increase blood flow and heart pumping activity. There has been particular interest in the role of Urocortins 2 \& 3 (subtypes of Urocortins) in heart failure.

In this study, we will examine the effects and mechanisms of Urocortins 2 \& 3 and the Corticotrophin Releasing Hormone Receptor Type 2 (CRH-R2) receptor (through which urocortins act) on forearm blood flow and release of natural blood clot dissolving factors in the forearm circulation of healthy volunteers.

In this study, we will look at the role of the lining of the blood vessel (endothelium) in response to urocortin types 2 and 3. We hypothesise that urocortins 2 \& 3 act via the endothelium to cause dilatation of the blood vessels and release of tissue-plasminogen activating factor (blood clot dissolving factor). We also hypothesise that urocortins have a role in maintaining the normal baseline level of blood flow in forearm arteries. In addition to the above, we will also look at the effect of temporarily blocking the effect of urocortins, using a specially designed blocker drug (Astressin 2B).

Utilising the well-established technique of 'forearm venous occlusion plethysmography', we will be able to focus on the local effects of urocortins on arterial blood flow in forearm vessels, without affecting this system in the body as a whole.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers between 18 - 65 years (inclusive)

Exclusion Criteria:

* Lack of informed consent- Age \<18 years \> 65 years
* Current involvement in a clinical trial
* Severe or significant co-morbidity including bleeding diathesis, renal or hepatic failure
* Smoker
* History of anaemia
* Recent infective/inflammatory condition
* Recent blood donation (prior 3 months)
* Positive baseline urine test for drugs of abuse (including cannabinoids, benzodiazepines, opiates, cocaine and amphetamines)
Video HIT in Sudden Sensorineural Hearing Loss

The function of the vestibular system among patients with Sudden Sensori Neural Hearing Loss will be evaluted using the video Head Impulse Test


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized with the diagnosis of Sudden Sensorineural Hearing Loss

Exclusion Criteria:

* Vertigo
* Other etiology causing dizziness
* Neurological dysfunction othe than the hearing loss
* Difficulty performing the vHIT
* Chronic vestibular disorder
* Pregnant women
A Proof of Concept Study for the DNA Repair Driven by the Mesenchymal Stem Cells in Critical COVID-19 Patients

Our aim in this study is to determine the positive effect of stem cell therapy applied on critically ill patients with coronavirus infection on DNA repair genes.

Patients diagnosed with COVID-19 infection are divided into two equal (n:30) groups. Group-1(n/15): Patients in critically ill condition receiving conventional therapy, Group-2 (n/15): Patients in critically ill condition receiving conventional therapy and systemically transplanted MSCs. The DNA repair pathway will be examined as 11 genes in 5 different parts. Investigated parameters:

1. Base excision repair
2. Nucleotide excision repair
3. Recombinational repair
4. Mismatch repair
5. Direct reversal Investigated parameters: broad biochemical analysis, apoptosis, clinical outcome, and mortality rates.

Our aim in this study is to determine the positive effect of stem cell therapy applied on critically ill patients with coronavirus infection on DNA repair genes.

Patients diagnosed with COVID-19 infection are divided into two equal (n:30) groups. Group-1(n/15): Patients in critically ill condition receiving conventional therapy, Group-2 (n/15): Patients in critically ill condition receiving conventional therapy and systemically transplanted MSCs. The DNA repair pathway will be examined as 11 genes in 5 different parts. Investigated parameters:

1. Base excision repair
2. Nucleotide excision repair
3. Recombinational repair
4. Mismatch repair
5. Direct reversal Investigated parameters: broad biochemical analysis, apoptosis, clinical outcome, and mortality rates.

Eligibility Criteria:
Inclusion Criteria:

1. 40-65 years old male/female.
2. Obtaining informed consent from him or his legal relative.
3. Confirmed COVID-19 related severe ARDS cases.

Exclusion Criteria:

pregnant, malignant tumours, the ones who has confirmed co-infection; history of using long-term immunosuppressive agents