cyrilzakka/clinical-trials huggingface dataset:
Physical Activity Interventions for Leg Ulcer Patients

The goal of this study is to test FOOTFIT and enhanced FOOTFIT+, home-based mobile health (mHealth) physical activity (PA) interventions for a minimally ambulatory, chronically-ill, population with leg ulcers. A highly sensitive clinically designed Bluetooth® enabled accelerometer and tracking device (BEAT) worn on the foot during a progressive and evidence-based non-exertive leg conditioning activities for lower leg function (CALF) captures minute foot movements and sends the data to a Smartphone. This six-week feasibility study will compare FOOTFIT to FOOTFIT+, with the added connectivity feature, to promote patient-provider communication, evaluate adherence to PA, and assess signals of efficacy on functional outcomes in a very low fitness population.

FOOTFIT is a study of a lower leg conditioning mHealth intervention for patients with venous leg ulcers. The aims are to compare two versions, one of which is enhanced (FOOTFIT+), to determine which has the greatest impact on physical activity adherence, patient-provider communication, and leg function. FOOTFIT and FOOTFIT+ share three components: 1) a low-cost, tri-axial Bluetooth® enabled highly sensitive accelerometer and tracking device (BEAT) worn on the foot during, 2) phased conditioning activities for lower leg function (CALF) tracked by a, 3) Smartphone that captures signals from BEAT, provides motivational messages, CALF instruction, and automated feedback on progress. Forty patients will be targeted in this six-week study, 20 of which will receive FOOTFIT and 20 FOOTFIT+.

Eligibility Criteria:
Inclusion Criteria:

* Active venous leg ulcer
* Ankle brachial index 0.80 to 1.3 mmHg, a measure of arterial sufficiency
* Sedentary-able to only walk a few steps at a time or not farther than 10 feet
* Not currently exercising or participate in a PA or physical therapy program
* Receives at least weekly wound care anticipated to last for at least six weeks from start of study
* Able to don accelerometer - if unable to apply independently, has assistance from other
* Capable of using Smartphone

Exclusion Criteria:

* Co-morbid conditions such as stroke (limits ankle function)
* Ulcer from other causes (arterial, diabetic, trauma, surgery)
* Documented cognitive impairment (MiniCog)
* No 3G service in area where patient resides
Acute Cardiorespiratory Effects of E-cigarette Inhalation

According to the World Health Organization cigarette smoking is today one of the leading single causes of preventable death and morbidity. The electronic cigarette (e-cigarette) has been marketed as a safer alternative to conventional cigarettes, and its global sales continue to grow exponentially each year. Despite growing e-cigarette use, scientific data on health effects are insufficient in some respects and completely lacking in others. Therefore the current study is designed to investigate the effects of active e-cigarette inhalation on the cardiovascular and respiratory systems.

It is estimated that 6 million people worldwide lose their lives due to tobacco use yearly. On average, cigarette smokers are estimated to die 10 years earlier than non-smokers. Ischemic heart disease, chronic obstructive pulmonary disease, stroke, respiratory illness, lung cancer and other cancers have all been linked to tobacco use. In recent years the electronic cigarette (e-cigarette) has been introduced to the market as an alternative to traditional cigarette smoking. E-cigarettes have been aggressively marketed as a cheaper, healthier, cleaner alternative to smoking in both advertising and media outlets, primarily targeting women and adolescents. With limited knowledge of e-cigarette vaping health effects in humans it has been challenging for governments and health officials to give advice and regulate the use of this novel product.

In the current study investigators aim to investigate acute cardiovascular and respiratory effects after active inhalation of e-cigarette in healthy human subjects.

Eligibility Criteria:
Inclusion Criteria:

* Intermittent/sporadic cigarette smoking
* Normal clinical examination
* Normal EKG
* Normal blood tests
* Normal lung function

Exclusion Criteria:

* Cardiovascular disease
* Respiratory disease
* Systemic or chronic disorders or disease
* Symptoms of infection or inflammation within 2 weeks of the study
* BMI≥30
* Pregnancy
* Current habitual cigarette smokers
Treatment for Presumed Ocular Histoplasmosis

The purpose of this study is to monitor safety outcomes for patients being treated with intravitreal aflibercept injections for choroidal neovascularization secondary to Presumed Ocular Histoplasmosis Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Active choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis demonstrated by active leakage on fluorescein angiography with spectal domain OCT evidence of subretinal or intraretinal fluid or PED.
* Active CNV may also be defined as demonstrating active subretinal hemorrhage.
* ETDRS Best corrected visual acuity 20/20-20/320.
* willing and able to comply with all study clinic visits and study related procedures.
* Willing to use and practice more than one form of contraceptives during the 13 month study for male and female.
* Provide signed informed consent
* Able to understand and complete study related questionnaires

Exclusion Criteria:

* Under 18 years of age
* CNV due to other causes than Presumed Ocular Histoplasmosis
* Previous treatment in the study eye within 6 months prior to Day 1
* More than 5 Intravitreal injections of anti-VEGF therapy within previous 12 months
* Any clinical evidence of any other ocular condition other than Ocular histoplasmosis
* History of allergy to fluorescein
* Pregnant( or planning on becoming pregnant within the next 13 months) or breast feeding women
* Sexually Active Men or Women who are NOT willing to practice more than one form of contraceptives during the next 13 months.
* Anticipated or previous (within previous 3 months) systemic anti-VEGF therapy
Association of Anthropometrics With Grip Strength and Smash Quality Post Six Week Elastic Resistance Training

To determine the association of hand and forearm anthropometrics on grip strength and forehand smash quality of badminton players after six-weeks of elastic resistance training.

As literature suggests that anthropometrics such as BMI and height do affect many game outcomes but specific anthropometrics have not been considered before so it is included in this study. Similarly the affects of elastic resistance training for lower limb has been recorded while the literature lacks for upper limb.

Eligibility Criteria:
Inclusion Criteria:

* collegiate players of Badminton.
* Players attending at least two training sessions per week for the past one month

Exclusion Criteria:

* Players having strain or sprain of upper or lower limb within the last months
* Payers having any cardiovascular, neuromusculoskeletal or other systematic pathology.
Hippocampal and Thalamic DBS for Bilateral Temporal Lobe Epilepsy

The study aims to compare the safety and effectiveness of deep brain stimulation of the hippocampus and the anterior nucleus of the thalamus for reducing the frequency of seizures in patients with bilateral temporal lobe epilepsy.

The outcome of resective surgery for bilateral temporal lobe epilepsy (BTLE) is poor. Neuromodulation such as deep brain stimulation is an alternative therapy for patients with drug-resistant epilepsy, especially for those not suitable for resective surgery. This prospective, randomized, open-label trial aims to compare the effectiveness of deep brain stimulation of the hippocampus and the anterior nucleus of the thalamus for bilateral temporal lobe epilepsy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between 12 to 60 years old.
2. Bilateral temporal lobe epilepsy patients proved by VEEG or SEEG.
3. At least 3 seizures per month but not more than 10 seizures per month, and the longest seizure interval is no more than 30 days during the baseline.
4. Patients failed to at least 3 antiepileptic drugs (AEDs), and are receiving at least 1 AEDs now.
5. Be able to complete seizure diary.
6. Agree to participate this study and sign informed consent.

Exclusion Criteria:

1. Extratemporal lobe epilepsy or with potential extratemporal epileptogenic focus.
2. Patients with psychogenic non-epileptic seizures.
3. IQ \< 70, or unable to complete the study.
4. Patients are pregnant or plan for it.
5. Patients with implanted electrical stimulation medical device.
6. Patients with other severe neuropsychiatric disorders such as dementia, schizophrenia, or neurodegenerative diseases.
7. Patients with cerebral lesions which unsuitable for lead implantation.
Open-Label Study of Omega 3 Oil Supplementation for Aging-Related Cognitive Decline

Aging-related cognitive decline may be affected by brain cholesterol and the health of cell membranes. Certain nutritional supplements have been proposed to support membrane health, and there is increasing interest in plasmalogens and Omega-3 derived oil supplements to support brain health among older adults. The product being investigated in this study is the ProdromeNeuro Omega 3 oil nutritional supplement. This product contains naturally occurring fatty acids in higher concentrations than similar products that are commercially available. The purpose of this research study is to better understand the effects of ProdromeNeuro Omega-3 nutritional supplementation among subjects with age-related cognitive decline.

There has been an increasing interest in plasmalogens as a potential therapeutic agent for age-related cognitive decline and neurodegenerative conditions, given the growing understanding of their involvement in key cellular functions as well as the clinical trends observed when plasmalogen levels are depleted. In addition to supporting the structural integrity of membranes, these plasmalogens are also involved in a variety of critically important cell functions: membrane fusion, ion transport, vesicle formation, and oxidation-reduction. Plasmalogen and serum plasmalogen deficiency has been shown to impair cellular functions, particularly related to cholesterol processing, and has been implicated in Alzheimer's and other diseases. Plasmalogen precursor supplementation has been demonstrated as safe and potentially efficacious in preclinical studies and some patient populations. In theory, ProdromeNeuro supplementation may yield therapeutic benefits among patients with age-related cognitive decline by increasing levels of neuroprotective plasmalogens.

The present study is being undertaken as an open-label study to evaluate the safety and tolerability of ProdromeNeuro Omega-3 Oil as an intervention for patients with age-related cognitive decline. Baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures. Neurocognitive assessment and serology testing kits to evaluate for plasmalogen levels will also be administered at baseline, end of the first month, end of the second month, end of the 3 month, and after one month post treatment termination.

Eligibility Criteria:
Inclusion Criteria:

* Cognitive decline due to aging-related changes
* Clinical Dementia Rating stage of mild dementia 0.5 through moderate dementia CDR stages 1 and 2

Exclusion Criteria:

* Subjects unable to give informed consent
* Cognitive decline clearly related to an acute illness
* Subjects taking anticoagulants and anti-platelet agents
* Advanced terminal illness
* Any active cancer or chemotherapy
* Any other neoplastic illness or illness characterized by neovascularity
Assessment of Transcutaneous Oxygen Tension/Oxygen Challenge Test in Intensive Care Unit (ICU) Patients

The lack of subcutaneous partial pressure of oxygen (PO2) rise in response to high fraction of inspired oxygen (FiO2), called the "oxygen challenge test (OCT)", was associated with higher morbidity and mortality in human subjects. Patients had negative O2 challenge test results, indicating that flow-dependent O2 consumption might have been present. Recent reports using the noninvasive transcutaneous PO2 (PtO2) and transcutaneous partial pressure of carbon dioxide probes have observed a relationship between low oxygen challenge test values to mortality and organ failure. The OCT values provides an accessible noninvasive method of detecting early shock.

To date,these studies of OCT in the ICU patients are rarely. No one has quantified OCT to CI, DO2I、ScvO2.

This study explored:

1. relationship between patient factors, hemodynamic variables, PtO2, and OCT to mortality;
2. relationship between PtO2 index, tissue oxygen index, oxygen Challenge index to CI, DO2, ScvO2.

PtO2 index = PtO2/PaO2；tissue oxygen index=PtO2/FiO2；

5min OCT value = challenged 5minPtO2 - PtO2baseline；

10min OCT value= challenged 10minPtO2- PtO2baseline；

oxygen challenge index = （10minPtO2- PtO2baseline）/(10minPaO2-PaO2baseline)

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Requiring a artery catheters, and pulmonary artery catheters or PiCCO-plus or central venous catheters
* FiO2\<80% and SpO2\>92%
* Consent informed

Exclusion Criteria:

* Not expected to live
Effect of Leg Strengthening Exercise After Hip Fracture

The purpose of this trial was to examine the effectiveness of a short-term leg strengthening exercise program compared to attention control on improving leg strength, walking speed and endurance, physical performance, and physical function one year after hip fracture.

Poor functional outcomes are reported for the majority of older adults who sustain a hip fracture. The ability of hip fracture patients to make sustained functional improvements above and beyond natural recovery is unknown. It has been shown that gym-based programs can help old adults regain function after hip fracture. It is unclear if these results could be translated into the home setting that lacks the gym-based equipment, or if improvement would be sustainable. This program compares high intensity strength training performed in the home twice weekly for 10 weeks to an attention placebo control in which participants receive sensory electrical stimulation to leg muscles.

Eligibility Criteria:
Inclusion Criteria:

* Successful fixation (partial or total hip replacement or open reduction internal fixation) of a hip fracture within the last 6 months
* Were 65 years of age or older, were living at home prior to the fracture, had a physician referral and were discharged from physical therapy.

Exclusion Criteria:

* Medical history of unstable angina or uncompensated congestive heart failure, ongoing chemotherapy or renal dialysis, history of stroke with residual hemiplegia, Parkinson disease, absent sensation in the lower extremities due to sensory neuropathy, life expectancy of less than 6 months, and Folstein mental status scores \< 20.
Effect of Prophylactic Application of 40Hz Transcranial Stimulation in AICU on Incidence of Postoperative Delirium in Elderly Patients Undergoing Elective Gastrointestinal Surgery

Postoperative delirium is an acute central nervous system dysfunction caused by surgical stress, which is manifested by postoperative acute, non-specific changes in consciousness level, attention, cognitive ability and disturbance of sleep and wake cycles. It is one of the most common surgical complications in the elderly, occurring in more than 75% of patients receiving mechanical ventilation in the intensive care unit(ICU).Exogenous 40 Hz stimulation can improve cognitive functioning.Therefore, the aim of this study was to investigate the effect of exogenous 40Hz stimulation on the incidence of postoperative delirium in elderly patients undergoing elective gastrointestinal surgery in AICU.


Eligibility Criteria:
Inclusion Criteria:

* 1.Age ≥ 65 years old,gender not limited
* 2.ASA classification Ⅱ \~ Ⅳ
* 3.Elective gastrointestinal general anesthesia surgery

Exclusion Criteria:

* 1.History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
* 2.Pre-operative coma, severe dementia, speech impairment or severe illness incapacitated and unable to communicate
* 3.Delirium on admission or pre-operative delirium, brain injury
* 4.Severely infected person
* 5.Severe liver dysfunction (Child-Pugh C), severe renal insufficiency (preoperative dialysis)
* 6.Severe hearing or vision impairment
A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis

To study the safety and effectiveness of multiple-doses of tralokinumab on pulmonary function in adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive, irreversible, and usually fatal lung disease of unknown cause.

The primary objective of this study is to determine the effect of multiple doses of tralokinumab on pulmonary function in adults with mild to moderate IPF

Eligibility Criteria:
Key Inclusion Criteria:

* 1) IPF diagnosis for \<= 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF in accordance is required for subject inclusion 2) Confirmed diagnosis of IPF by clinical characteristics, HRCT and surgical lung biopsy (if required) 3)Mild to moderate IPF to include all of the following at screening:

  1. FVC \>= 50% predicted normal
  2. Partial pressure of oxygen in arterial blood (PaO2) of \>= 55 mmHg on room air or 50 mmHg at high altitude (\> 1500 meters), or oxygen saturation by pulse oximetry (SpO2) of \>= 90%on room air at rest
  3. Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) \>= 30% predicted normal 4) Be able to walk \>= 100 meters unassisted

Key Exclusion Criteria:

1. A FEV1/FVC ratio less than 0.70 at the time of screening (postbronchodilator)
2. The extent of emphysema on the HRCT is greater than the extent of fibrosis.
3. Currently listed for lung transplantation
4. Use of the following medications:

   1. Immunosuppressive medications (eg, methotrexate, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid) within 3 months prior to Visit 1 (screening). Oral prednisone \<= 15 mg/day (or equivalent oral corticosteroid) is allowed for chronic use if subject was on a stable dose at least 30 days prior to Visit 1 (screening)
   2. Pirfenidone within 4 weeks prior to Visit 1 (screening)
   3. N-acetylcysteine within 4 weeks prior to Visit 1 (screening)
   4. Live attenuated vaccines within 4 weeks prior to Visit 1 (screening)
Clinical Feasibility of Brain Radiotherapy Using Synthetic CTs in an MRI-only Workflow

The goal of this observational study is to show the feasibility of an MRI-only workflow in brain radiotherapy. The main question it aims to answer is:

* Is an MRI-only workflow based on deep learning sCTs feasible in clinical routine? Participants will be treated as in clinical routine, but treatment planning will be based on sCTs, that are generated from MRI images. The dosimetrical equivalence to the standard CT based workflow will be tested at several points in the study.

The purpose of this clinical study is to investigate the clinical feasibility of a deep learning-based MRI-only workflow for brain radiotherapy, that eliminates the registration uncertainty through calculation of a synthetic CT (sCT) from MRI data.

A total of 54 patients with an indication for radiation treatment of the brain and stereotactic mask immobilization will be recruited. All study patients will receive standard therapy and imaging including both CT and MRI. All patients will receive dedicated RT-MRI scans in treatment position. An sCT will be reconstructed from an acquired MRI DIXON-sequence using a commercially available deep learning solution on which subsequent radiotherapy planning will be performed. Through multiple quality assurance (QA) measures and reviews during the course of the study, the feasibility of an MRI-only workflow and comparative parameters between sCT and standard CT workflow will be investigated holistically. These QA measures include feasibility and quality of image guidance (IGRT) at the linear accelerator using sCT derived digitally reconstructed radiographs in addition to potential dosimetric deviations between the CT and sCT plan. The aim of this clinical study is to establish a brain MRI-only workflow as well as to identify risks and QA mechanisms to ensure a safe integration of deep learning-based sCT into radiotherapy planning and delivery.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Patient older than 18 years
* Tumor or metastases in the brain
* Immobilization with stereotactic mask
* Treatment on stereotactic linear accelerator (2.5 mm leafs) equipped with 2D/2D X-ray system

Exclusion Criteria:

* Metal in the body, metal implants, pacemakers or other patient-specific factors that are a contraindication to an MRI scan
* Metal implants, pacemakers or other patient-specific factors associated with increased risk from an MRI scan
* Renal insufficiency (eGFR \< 60 ml/min), allergy or other patient-specific factors that constitute a contraindication to contrast administration
* Renal insufficiency (eGFR \< 60 ml/min), allergy or other patient-specific factors associated with an increased risk from contrast administration
* Patients who are institutionalized in care facilities, prisons or other supervised facilities.
* Patients under guardianship
* Non-consenting patients
* Pregnant or breastfeeding patients
Study of Mental Fatigue in Polio Survivors

Post-Poliomyelitis Syndrome (PPS) is the term describing the new problems affecting polio survivors many years after recovery from paralytic polio. Among the symptoms, fatigue is one of the most frequent and debilitating. In addition to physical incapacitation, the fatigue of PPS also affects mental function. The term "brain fatigue" is usually used by patients to express problems on the areas of attention, concentration, memory and clear thinking. Unfortunately, little is known about cognitive fatigue of PPS patients. This study is meant to examine if mental impairment is present in PPS patients and, if so, how it interferes on the self-function of patients. Patients will undergo an interview, clinical and neurological evaluation, and a battery of screening laboratory tests to make sure they are eligible for the study. Patients who qualify will undergo neuropsychometric tests in order to assay performance in the main areas of cognitive functioning. Through this organized approach we expect to be able to determine if mental fatigue is a significant problem affecting polio survivors, what areas are most affected, and how it may interfere with daily living.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Be a survivor of poliomyelitis
* Willing to attend two clinic visits for completion of screening procedures and required tests

Exclusion Criteria:

* Suffer from medical conditions that can interfere with cognitive function, including stroke, traumatic brain injury, dementia (progressive memory loss), severe depression, psychosis or other psychiatric disorders, etc.