cyrilzakka/clinical-trials huggingface dataset:
Open-Label Influenza Vaccine Evaluation

This is an open-label, randomized trial in up to 210 adults aged 65-74 years to evaluate the immune response to consecutive influenza vaccination across 2 seasons. Participants will be randomized to receive 1 of 3 licensed and recommended vaccines in the first year; 2 arms will receive the same vaccination in the second year and the third arm will be randomized again to 1 of 3 licensed vaccines. All participants will have pre and post-vaccination serum blood draws for a total of 6 draws over 18 months.


Eligibility Criteria:
Inclusion Criteria:

* Age 65-74 years at the time of study enrollment and are ambulatory and live in selected Wisconsin community or surrounding communities.
* Willing and able to give informed consent prior to study enrollment
* Able to comply with study requirements.

Exclusion Criteria:

* Prior receipt of 2016-17 influenza vaccine
* Current participation in another clinical trial
* Presence of a contraindication to influenza vaccine
Use of 'Mechanical Power' as a Predictor of Increased Serum and Pulmonary Proinflammatory Cytokine Concentrations in Patients With Acute Hypoxemic Respiratory Failure: A Prospective Observational Study

The aim of this study is to report the proportion of patients with acute hypoxemic respiratory failyre (AHRF) undergoing mechanical ventilation who exceed 17 J/min of mechanical power (MP) and the difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage.

The main questions it aims to answer are:

1. Which is the proportion of patients who exceed 17 J/min of mechanical power (MP) during the first 72 hours of mechanical ventilation?
2. Is there a difference in terms of cytokine concentration in patients undergoing mechanical power \>17 J/min compared to \<17 J/min?

Patients will be divided into two groups based on respiratory mechanics measurements: low MP group (average MP \<17 J/min) and high MP group (average MP ≥17 J/min). The researchers will collect blood and BAL samples and perform cytokine assays.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AHRF (P/F \<300 mmHg) undergoing invasive mechanical ventilation within 7 days from the onset of symptoms
* Invasive mechanical ventilation for less than 6 hours
* Evidence of newly developed lung consolidation on chest imaging (X-ray, CT)
* Age ≥18 years

Exclusion Criteria:

* Prior invasive mechanical ventilation during the same hospitalization
* Tracheostomy
* Severe anemia (Hb\<7g/dL)
* Severe neutropenia
* Renal insufficiency or RRT (Renal Replacement Therapy)
* Noradrenaline \>0.5 mcg/kg/min
* Pregnancy
* Extracorporeal circulation (ECCO2R, ECMO)
* Life expectancy \<24 hours as clinically judged
* Lack of consent
Apnoea-Hypopnoea-Indices Determined Via Continuous Positive Airway Pressure vs Those Determined by Polysomnography

To date, no published systematic review and meta-analysis has compared AHI-CPAPflow and AHI-PSGgold. Therefore, the primary objective of this study is to compare published data for AHI-PSGgold and AHI-CPAPflow in patients treated by CPAP.

The secondary objectives are to evaluate, in a manner similar to the primary objective, data for apnoea indices (AI), hypopnoea indices (HI), respiratory disturbance indices (RDI) and respiratory effort related arousals (RERAs) and to perform subgroup analyses focusing on the inclusion/exclusion of central apnoea patients, BMI levels, CPAP device brands, pressure titration modes, use of a predetermined and fixed pressure level or not, and the impact of a 4%-PSG desaturation criteria versus 3%-PSG on index accuracy.

Eligibility Criteria:
Inclusion Criteria:

* All (full scientific) study designs and publication types written in English and reporting Bland-Altman test results (or other tests suggesting the presence of the required data) between simultaneous, paired, polysomnography (PSG)-derived AND Continuous Positive Airway Pressure (CPAP)-derived data describing sleep disordered breathing.

Exclusion Criteria:

* Duplicates
* Does not refer to a full scientific article (e.g. case reports are excluded).
* Meta-analysis
* Paediatric populations (populations \<18 years are excluded).
* Absence of appropriate paired results: synchronized polysomnography (PSG)-derived AND Continuous Positive Airway Pressure (CPAP)-derived data must be reported for ≥1 of the following measures: Apnoea-Hypopnoea-Indices (AHI), Apnoea-Indices (AI), Hypopnoea-Indices(HI), respiratory disturbance index (RDI), respiratory effort related arousals (RERA).
* Absence of appropriate test comparing paired results: the study must use ≥1 of the fol-lowing tests to compare the previously mentioned PSG-vs-CPAP-derived data: a bland-altman or correlation test, other conformity tests, tests of differences in centrality.
* Inappropriate PSG scoring 1: PSG-derived variables must be coded following the American Academy of Sleep Medicine 2007 (or more recent) guidelines.
* Inappropriate PSG scoring 2: PSG-derived variables must be scored manually.
* Inappropriate PSG scoring 3: oxygen desaturation level used for scoring must be mentioned and at 3% or 4%.
* Inappropriate CPAP description: brand/device names must be mentioned.
Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)

This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy.

Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week

Exclusion Criteria:

* Legal lower age limitations (country specific) Indication for therapeutic-dosed anticoagulants Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Calculated creatinine clearance \< 30 mL/min
Nourishing Hair, Skin & Nails Supplement Study (Derm Aid)

A 90 day eight arm virtual interventional study looking at the impact of various supplement formulations for improves in hair, skin \& nail health via self report, and dermatology assessment via remote dermatologist assessment.

This study is being run entirely on the ProofPilot clinical trial platform. Participants enroll online, submit selfies, and are shipped dietary various dietary supplements containing a one or more of Keratin, Astaxanthin, Collagen Peptides and Pro-berry powder in vegan and non-vegan formats. All participants will receive active ingredients but in various fomulations.

Half the participants will receive the formations for free. The other half will pay a discounted amount for the supplements.

Eligibility Criteria:
Inclusion Criteria:

* Continental US
* ability and willingness to take selfies

Exclusion Criteria:

* skin diease
* use of retinoids
* known allergies
* significant facial hair
* medically relevant skin disease
Grafts of GSCs Into Brain Organoids for Testing Anti-invasion Drugs

In patients operated for glioblastoma, glioma stem-like cell lines will be obtained from tumor tissue, and IPSCs from skin fibroblasts or PBMCs. Brain organoids will be generated from IPSCs and co-cultured with IPSCs to study brain invasion and ciliogenesis. 3D genome architecture of glioma stem-like cells will be investigated. Gene modulation and pharmacologic strategies to inhibit invasion and restore ciliogenesis will be explored.


Eligibility Criteria:
Inclusion Criteria:

o be enrolled in the study patients must:

1. Have a radiological diagnosis of supratentorial glioblastoma, or
2. Have a radiological diagnosis of first recurrence of a primary supratentorial glioblastoma (for which a formal histopathologic diagnosis of glioblastoma had made at first surgery), according with RANO criteria (Wen, 2010);
3. Be a candidate to neurosurgery for glioblastoma;
4. Be of an age of 18 years or above;
5. Provide written informed consent for participation to the study.

Exclusion criteria

To be enrolled in the study patients must not:

1. Have not enough pathological material removed at surgery available both for mandatory routine histopathological diagnosis and for the present study, as judged by the Principal Investigator;
2. Have not a definitive pathological diagnosis of a primary supratentorial glioblastoma, according with 2016 WHO classification.
Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis

Autoimmune encephalitis (AE) is an immune-mediated brain disorder characterized by varied clinical manifestations that correlate with specific types of antibodies.Typical symptoms include acute behavioral changes, psychosis, seizures, memory deficits, dyskinesias, speech impairments, and autonomic and respiratory dysregulation.While the majority of patients respond well to immunotherapeutic agents, a significant proportion remains resistant to initial and secondary-line immunotherapies.Minocycline, a semisynthetic tetracycline, is notably used for the central nervous system due to its lipophilic characteristics and its capacity to penetrate the blood-brain barrier. While the primary neuroprotective focus of minocycline in the central nervous system remains unknown, the primary effects of minocycline include the inhibition of microglial activation, mitigation of apoptosis, and reduction in reactive oxygen species generation.Protective effect has been observed in hypoxic injury, ischemic stroke, amyotrophic lateral sclerosis, traumatic spinal cord injury, multiple sclerosis, Parkinson's disease, and Huntington's disease.Can minocycline offer a protective role in AE? Consequently, we proposed a randomized, controlled trial to investigate the efficacy of minocycline in AE.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of definite autoimmune encephalitis(Graus et al 2016.)
2. Age ≥ 18 years
3. Acute or subacute onset (rapid progression of less than 3 months)
4. Reasonable exclusion of alternative causes
5. Written informed consent

Exclusion Criteria:

1. Known allergy to tetracycline antibiotics.
2. Pregnant women.
3. Uncontrolled serious concomitant illness.
4. Known chronic kidney disease stages 3b-5.
5. Moderate liver disease (see Child-Pugh for Classification of Severity of Liver Disease).
6. history of cognitive impairment
Is Ultrasound Comparable to Chest X-ray in Verification of Intensive Care Patients Enteral Feeding Tube Positioning.

The goal of this observational study is to investigate methodological if ultrasound is comparable to chest X-ray in verification of intensive care patients enteral feeding tube positioning.

The main question to answer is: Is ultrasound a comparable method to chest X-ray in verification of intensive care patients enteral feeding tube positioning.

In Norway, around 4000 patients are yearly in need of ventilator, and many of them will need enteral nutrition through a feeding tube. 40 % of all intensive care patients have signs of malnutrition. If ultrasound is a comparable method to chest X-ray in verification of intensive care patients enteral feeding tube positioning, then enteral nutrition in many cases can be started several hours earlier than using chest X-ray verification. The ultrasound examination will be performed in a research based in a 4-step approach. In this project 20-30 intensive care patients prescribed by a medical physician to have an enteral feeding tube will be included in the project due to written informed consent by 1) Awake intensive care patient or by 2) Patients informal caregiver if the patient is not competent to consent.

Eligibility Criteria:
Inclusion Criteria:

* Intensive care patient prescribed by a medical physician to have an enteral feeding tube

Exclusion Criteria:

* \<18 years
Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department

This is a pilot feasibility acceptability study to examine the impact of smartphone-based progressive muscle relaxation (PMR) on migraine quality of life, frequency, intensity, and disability. Feasibility is measured by: a) Proportion of patients who enrolled in the study/were recruited for the study, b) Number of days PMR practiced/week as determined with the backend analytics in the RELAXaHEAD app, c) Minutes/day spent doing PMR, d) Reasons for non-adherence. Acceptability is measured by: a) Satisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality b) Willingness to repeat a similar treatment intervention in the future (Definitely No/Probably No/Unsure/Probably Yes/ Definitely Yes) c) Attrition. In addition, whether use of electronically based PMR introduced in the emergency department (ED) improves migraine quality of life (MSQv2) and migraine related disability (MIDAS) at 3 months post ED-discharge (or post enrollment date if recruited post ED discharge) compared to those who are not introduced to PMR will be assessed. All participants will be asked to track their headache frequency and intensity using our smartphone application (app) and will be asked to complete migraine quality of life assessments and migraine related disability at follow-up.

While explaining the study, potential participants will be assured that they will receive all of the medication for their acute headache that they would otherwise receive. Once consented, participants will be randomized to PMR therapy or monitored usual care (MUC). Participants will be told that either group is being tested as an enhancement to the care they typically get in the ED for headache. (At the end, they will be informed which group they were in.) The study team will collect participants' health histories (biologic variables) and baseline data in REDCap, download the app onto subjects' smartphones, and conduct the sessions.

Eligibility Criteria:
Inclusion Criteria:

* Meets migraine criteria and has 4+ headache days a month

Exclusion Criteria:

* Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy in the past year
* Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy
* Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record
* Unable or unwilling to follow a treatment program that relies on written and audio recorded materials
* Not having a smartphone
Extracorporeal Shock Wave Therapy Versus High Power LASER Therapy for the Treatment of Females With Calcaneal Spur

PURPOSE: To compare the effect of Extracorporeal shock wave therapy and high-power LASER therapy for the treatment of patients with calcaneal spur Background: Calcaneal spur is a common musculoskeletal disorder of the foot that affect the quality-of-life Conservative treatment modalities include, cold application, platelet-rich plasma therapy (PRP), shoe modification, therapeutic ultrasound, extracorporeal shock wave therapy (ESWT), laser therapy (LLLT) are commonly used in the treatment of calcaneal spur.

HYPOTHESES: There will be difference between Extracorporeal shock wave therapy and High- power LASER therapy on pain intensity in patients with calcaneal spur There will be difference between Extracorporeal shock wave therapy and High- power LASER therapy on function in patients with calcaneal spur. There will be difference between Extracorporeal shock wave therapy and High- power LASER therapy on the size of calcaneal spur in patients with calcaneal spur.

RESEARCH QUESTION: Is there any difference between the effect of Extracorporeal shock wave therapy and High-power LASER on calcaneal spur?


Eligibility Criteria:
Inclusion Criteria:

diagnosed with calcaneal spur based on clinical examination and radiological findings.

Exclusion Criteria:

were as follows: acute trauma to the foot, history of fracture or surgery, lower extremity neurological deficit, polyneuropathy, radicular pain, autoimmune diseases tumor, thrombosis, soft tissue or bone infection, or skin disorder.
Telehealth Exercise Intervention to Improve Physical Function and Frailty in Multiple Myeloma Survivors

This clinical trial examines a telehealth exercise intervention in improving physical function and frailty in multiple myeloma survivors. The exercise program uses a telehealth platform (delivered by smart phones, tablets, or computers) to view pre-recorded exercise videos on coordination, posture, stretching, balance, and resistance/aerobic (cardio) training. Frailty includes being underweight, slow walking speed, exhaustion, low physical activity, and weakness. Participating in an exercise program may help improve patient's physical function and strength.

PRIMARY OBJECTIVE:

I. Determine the effects of an 8-week telehealth exercise intervention on physical function as assessed by the Short Physical Performance Battery (SPPB) test (Aim 1)

SECONDARY OBJECTIVES:

I. Determine the effects of an 8-week telehealth exercise intervention as assessed using a 5-scale frailty index: body mass index (self-report), tiredness (questionnaire), level of physical activity (self-report), gait speed (sensors), and muscular strength (hand grip dynamometer) (Aim 2).

II. Determine the sustainability of the intervention on physical function and frailty at week 17 (Aim 3).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo home-based exercise program 3 times per week for 8 weeks. Patients complete questionnaires at baseline (before 1 week) and at weeks 9 and 17.

ARM B: Patients complete questionnaires at baseline and at week 9 and 17. Patients continue maintaining current activities of daily living and do not participate in any exercise program. Patients may then participate in home-based exercise program 3 times per week for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with multiple myeloma
* \>= 18 years old
* Self-reported as pre-frail or frail (i.e. Fried Criteria: clinically underweight and exhibiting exhaustion, low energy expenditure, slow walking speed, and muscle weakness), with the presence of 2/5 indices classified as pre-frail and \>= 3/5 indices classified as frail
* Has undergone autologous stem cell transplant (ASCT) within 30 and 180 days prior to registration
* Physically able and willing to complete all study procedures
* English-speaking

Exclusion Criteria:

* Have clinically significant/active cardiovascular disease (e.g. unstable angina, uncontrolled arrhythmia, etc.)
* Have contraindications to exercise (acute infectious disease or unstable bone lesions)
* Currently recovering from a recent injury or have been physically injured in the past 6 months, in which participation in rigorous exercise may not be appropriate
* Participate in regular, structured exercise (\> 60 minutes/week)
* Female patients who are pregnant or planning to become pregnant
Effects of Extended Haemodialysis Treatment Duration in Patients With End-stage Renal Disease

Design: Prospective randomised cross-over study. Fifty-two eligible patients will be randomised to a treatment time of either 6 hours or 4 hours for a period of 24 weeks and following a washout period of 4 weeks, switch to the alternative treatment time for an additional 24 weeks.

Aims: To examine the feasibility and effect of extended dialysis treatment time, 6 hours thrice weekly, versus the standard, 4 hours thrice weekly, comparing the differences from baseline in outcome measures over a total 12-month period.

Primary outcome measure

1\]Serum albumin

Secondary outcome measures Nutritional status

1. Malnutrition-inflammation score
2. Dietary intake
3. Hand-Grip strength
4. Energy expenditure

Quality of life

1. Patient reported quality of life and
2. time to recovery from dialysis

Serum biomarkers

1. BNP
2. Troponin
3. MCP-1

Others 24- hour Ambulatory blood pressure 24-hour accelerometer

Population: Local haemodialysis population of 1200 patients Eligibility: Minimum 90days on haemodialysis treatment Duration: Fifty-six weeks


Eligibility Criteria:
Inclusion Criteria:

* Dialysis dependant for over 90 days

Exclusion Criteria:

1. Haemodialysis for less than 90 days
2. Patients with anticipated life expectancy less than 6 months secondary to significant morbidity e.g. metastatic malignancy, advanced human immunodeficiency virus
3. Patients with acute liver disease; History of underlying haematological condition;
4. Elective planned change of renal replacement modality within the 12 months.
The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine Stone Formation: A Preliminary Study

Cystinuria is an inherited autosomal recessive disorder of the kidney that is the result of an inability to reabsorb cystine from the urine. Supersaturation of cystine in the urine produces crystals that precipitate and form stones in the kidney, which can be a cause of obstruction, infection, and chronic kidney disease. Cystine stones constitute a major health challenge for affected individuals with cystinuria because of the frequent recurrence of painful symptoms and the current absence of effective, patient-accepting treatment.

A mainstay of therapy is breaking or preventing the cystine bond on the molecular level such that cystine (which is formed from the joining of two cysteine amino acids and their corresponding sulfur atoms) cannot precipitate in the urine. It is hypothesized that a glucose molecule may be able to do this if introduced into the urine. SGLT-2 inhibitors are a class of drug that are FDA approved to treat diabetes mellitus (DM) and heart failure by inhibiting an enzyme in the kidney that allows for reabsorption of glucose from the urine. This effectively increases the concentration of glucose in the urine. Our hypothesis suggests that administration of this drug to patients with cystine will introduce sufficient glucose into the urine to prevent the formation of cystine stones. To date, there has been no published data on the effectiveness of this therapy for this indication, although the dosage and administration would be identical to that already approved by the FDA for the treatment of DM and heart failure.

This is a single center, proof of concept prospective cohort trial designed to assess the effect of daily oral administration of dapagliflozin on cystine formation in freshly voided urine. Five subjects are planned, each with previously diagnosed cystinuria and without current treatment except with potassium citrate medication.

Total duration of subject participation with be up to four weeks. Total duration of the study is expected to be 6 months.

Eligibility Criteria:
Inclusion Criteria:

* males and females age 18 or older
* documented cystinuria on prior 24-hour urine collection and/or stone analysis
* history of previous cystine kidney stones
* able and willing to provide consent

Exclusion Criteria:

* prior diagnosis of diabetes mellitus (type I or type II)
* current SGLT-2 inhibitor administration at the time of screening
* SGLT-2 inhibitor administration within the last year prior to screening
* vulnerable populations including incarceration status
* anticipation of pregnancy during the study duration
* unable to give informed consent
* non-English primary language
* pregnancy, lactation, or child- bearing age without birth control devices
* serious illness likely to cause death within the next 5 years.