cyrilzakka/clinical-trials huggingface dataset:
A Longitudinal Study of Function and Participation in Patients With Stroke

A longitudinal study of function and participation in patients with stroke: An integrated brain imaging and biomechanical analysis

Brain damage may lead to various motor deficits, which further influence the function and participation. Cerebral vascular accident (CVA) is the common disorder for acquired brain damage. Neural network in patients with brain damage could also be used to determine their clinical behavior by identifying altered neural network associated with behavioral improvement. The investigators hypothesize that the level of brain image and biomechanical will change with time in patients with stroke. Under this hypothesis, the measures of biomechanical change are correlated with neural changes. The aim of this study is to investigate the function and participation in patients with stroke evaluated by clinical measures, biomechanical, psychological, physiological and multimodal brain image. The primary goal of this study is to establish, evaluate and follow-up biomechanical- and image-based biomarkers for the impairment of function and participation information processing present in patients with stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with stroke
2. Aged 20-80 years old
3. Both ischemic stroke and hemorrhage

Exclusion Criteria:

1. Contraindication to MRI, such as metallic implant
2. History of psychiatric disease
3. Received Botulinum toxin (BTX-A) injection or surgery in recent six months
4. Severe psychological impairments, such as mental retardation or severe Communication problems
5. Progressive disorders, such as neurodegenerative disease
6. Active medical disease, such as infection
Radical Prostatectomy and External Beam Radiotherapy in mCRPC With 223Radium-dicloride (RaProRad)

The investigators provided a multicenter analysis aiming to investigate, in a clinical practice setting, the prognostic relevance of previous primary radical prostatectomy (RP) or external beam radiotherapy (RT) in terms of Overall Survival as opposed to patients with no primary treatment performed, in a cohort of patients enrolled in 223-Ra treatment for mCRPC. 223-Ra has been administered from investigators according to the current label authorization and all patients underwent 223-Ra treatment, until disease progression or unacceptable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* histological confirmation of prostatic adenocarcinoma, at least two symptomatic bone secondary lesions detected by bone scan and no known visceral metastases, except for malignant lymphadenopathy with less than 3 cm in the short axis diameter

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score \>2 and inadequate hematological, hepatic and renal function
An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Treated With Glucocorticoids

This prospective, observational, multicenter study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate response to previous disease-modifying antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adults patients, over 18 years of age
* Patients with moderate to severe rheumatoid arthritis (RA)
* Patients on a stable dose of prednisone or equivalent (\>/=7.5 mg/day) for at least 4 weeks before study inclusion

Exclusion Criteria:

* Patients previously treated with RoActemra/Actemra
* Any contraindication to RoActemra/Actemra
A Study of Patients With HER2-Positive Metastatic Breast Cancer

This is a prospective observational cohort study designed to describe effectiveness and safety (treatment outcomes and clinically significant cardiac adverse events, respectively) in patients with HER2-positive metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent document (unless the IRB has granted a waiver of consent)
* Signed Authorization for the Use and Disclosure of Health Information document
* HER2-positive breast cancer
* Initial diagnosis of metastatic (Stage IV) breast cancer within 6 months prior to enrollment
* Availability of cancer-specific historical data points in the patient's medical records

Exclusion Criteria:

* There are no exclusion criteria for participation in this trial
Guam Healthy Relationships Education Program

The Guam Healthy Marriage Partnership (GHMP), a comprehensive culturally responsive program that will foster healthy relationships and marriages on the island of Guam.

The proposed Guam Healthy Relationships Education Program will improve the quality of life for individuals/couples in Guam by using culturally responsive approaches to foster healthy relationships and marriages using an Observational approach as there will be no comparison group, only the control group. Project activities include a 6-month education program of interactive curriculum-based groups and positive social/recreational activities to achieve positive outcomes for individuals/couples, community awareness events, and community and parenting skills training. The services offered is entrenched in cultures and traditions that are meaningful to the people of Guam, and includes capacity building and community awareness activities that will change community, family, and peer normative environments and attitudes.

Eligibility Criteria:
Inclusion Criteria:

* Currently in a long-term relationship, does not have to include marriage
* Must be at least 18 years old
* At least one of the partners need to be between the ages of 18-35 years old

Exclusion Criteria:

* Under the age of 18 years
* Not in a long-term relationship
Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care

This clinical trial studies direct visual fluorescence in finding oral cancer in high-risk patients and patients undergoing routine dental care. Diagnostic procedures, such as direct visual fluorescence, may help find and diagnose oral cancer.

PRIMARY OBJECTIVES:

I. To assess the diagnostic benefit of the VELscope (direct visual fluorescence) inspection in oral examination.

II. Efficacy of the VELscope in identifying dysplastic (premalignant) and malignant oral mucosal lesions and in discriminating these lesions from common benign tissue changes.

III. Accuracy of clinical judgment versus VELscope findings. IV. Ability of the VELscope to identify lesions or extent of lesions beyond what is clinically apparent.

OUTLINE:

Patients undergo conventional oral examination (COE) followed by direct visual fluorescence examination (DVFE). Patients with tissue abnormalities found by COE or DVFE undergo scalpel biopsy within 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* HIGH-RISK POPULATION:
* 33 consecutive consenting patients presenting to The Ohio State University James Cancer Hospital Otolaryngology Department with a suspicious oral lesion or prior biopsy-confirmed epithelial dysplasia (mild, moderate, severe), carcinoma in situ (CIS), or squamous cell carcinoma (SCC) will be recruited; adult patients presenting for initial evaluation for treatment planning and/or presenting for follow-up appointments monitoring for recurrence will be eligible to participate
* GENERAL POPULATION:
* 250 consecutive consenting patients presenting to The Ohio State University College of Dentistry for routing dental care will be recruited; adult patients presenting to the screening clinic for initial oral evaluation will be eligible to participate
Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Capsules

A single dose, two treatments (two cephalexin capsules brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. Treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis

Exclusion Criteria:

* History of illnesses or any organic abnormalities that could affect the results of the study
* History of tobacco or alcohol abuse or regular use of recreational or therapeutic drugs
* Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup
A Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis

The aim of the study is to evaluate the efficacy and safety of Enstilar Foam (calcipotriene and betamethasone dipropionate) for the treatment of nail psoriasis.

Eligible subjects will be provided once daily Enstilar Foam (calcipotriene and betamethasone dipropionate). Subjects will be instructed to apply a thin layer on the nail plate, around the nail plate and under the nail plate. The subject will be instructed to apply one application at night immediately before bed and not wash their hands before morning. All subjects who completed the 6-month treatment will be followed for 1 month after discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis of nail psoriasis in fingernail or toenails
* History of plaque psoriasis or psoriatic arthritis
* Target nail will be KOH negative for dermatophyte fungus
* Must give written informed consent prior to study procedures being conducted, also give consent to the release and use of protected health information (PHI)
* Between the ages of 18 and 85 years old
* Candidate for topical therapy in the opinion of the investigator

Exclusion Criteria:

* Males and Females unable to practice effective contraception throughout the study
* Unable to comply with the protocol
* Nursing mothers, pregnant women, and women planning to become pregnant while in this study
* Patients with erythrodermic or pustular psoriasis
* Sustained treatment to target fingernail within 6 months prior to screening
* History of trauma or surgery to target fingernail
* History of disease known to affect nails such as lichen planus, onychomycosis
* History of systemic psoriasis therapy for less than 6 months
Short Segment Fixation in Thoracolumbar Osteoporotic Fracture

Although long-segment posterior spinal fixation might provide more rigid fixation, the procedure increases perioperative morbidities in the elderly. The present study reviews the results of short-segment decompression and reconstruction in thoracolumbar fragile fractures.

This study included 20 elderly patients with osteoporotic thoracolumbar burst fractures and neurological compromise. The participants were followed-up for a period of 40.6 (24-68) months. A visual analog scale (VAS) and the Oswestry Disability Index (ODI) were used to measure back pain and disability. Radiologic assessment and neurological status were also analyzed.

Eligibility Criteria:
Inclusion Criteria

* osteoporotic burst fracture at a single level of the thoracolumbar region
* dual-energy X-ray absorptiometry and T-score value less than -2.5

Exclusion Criteria

* translational displacement at the fracture site (fracture-dislocation)
* loss of structural integrity within the posterior osteoligamentous complex (such as flexion-distraction ligament disruption)
* spondylolisthesis of the adjacent vertebrae
* malignancy
* chronic steroid administration
* previous spinal surgery
* prior vertebroplasty and infection
Physical Activity After Cardiac Arrest; a Sub-study in the Target Temperature Management Trial 2

The Target Temperature Management trial 2 (TTM2) is an international multi-center study, that randomize patients with OHCA of a presumed cardiac or unknown cause to target temperature management at 33°C or normothermia but avoiding fever (37.8°C) for the first 24 hours after the OHCA. The TTM2 study (clinicaltrials.gov Identifier NCT02908308) includes a detailed follow-up of functional outcome, health-related quality of life and neurocognitive function at 6 and 24 months post-arrest. This protocol describes a sub-study within the TTM2 trial that specifically focus on physical activity among the OHCA survivors.

The primary aim of this study is to investigate whether OHCA-survivors have lower levels of self-reported physical activity compared to a non-cardiac arrest (CA) control group who had acute myocardial infarction (MI). Additional aims are to explore potential predictors of physical inactivity (older age, female gender, problems with general physical function, global cognition, mental processing speed/attention, anxiety symptoms, depression symptoms, kinesiophobia, fatigue), and to investigate the relationship between self-reported and objectively measured physical activity among OHCA-survivors.

Eligibility Criteria:
Inclusion Criteria:

* The TTM2 main trial includes adult, unconscious patients with sustained return of spontaneous circulation after cardiac arrest of a presumed cardiac origin. The aim is to include 100-150 OHCA-survivors to the sub-study.

Exclusion Criteria:

* An exclusion criterion for the TTM2 main trial is an unwitnessed cardiac arrest with initial rhythm asystole, temperature at admission \<30°C, on extracorporeal membrane oxygenation (ECMO) prior to return of spontaneous circulation (ROSC), obvious or suspected pregnancy, intracranial bleeding and/or severe chronic obstructive pulmonary disease (COPD) on home oxygen.

An additional exclusion criterion for the sub-study is the inability to speak the local language well enough to complete the test without an interpreter. Patients with major cognitive impairment, patients sitting in a wheel chair, Clinical Frailty Score 8 or 9 (very severely frail or terminally ill), active drug abuse and when a face-to face follow-up is not possible will also be excluded.
Effect of Neck Strength Training on Health-related Quality of Life in Females With Neck Pain

The purpose of this study is to determine whether intensive one-year neck strength training can enhance health related quality of life in females with chronic neck pain.


Eligibility Criteria:
Inclusion Criteria:

* female
* aged 25 to 53 years
* office worker
* permanently employed
* motivated to continue working
* motivated for rehabilitation
* constant or frequently occurring neck pain for more than 6 months

Exclusion Criteria:

* severe disorders of the cervical spine
* disk prolapse
* spinal stenosis
* postoperative conditions in the neck and shoulder areas
* history of severe trauma
* instability
* spasmodic torticollis
* frequent migraine
* peripheral nerve entrapment
* fibromyalgia
* shoulder diseases (tendonitis, bursitis, capsulitis)
* inflammatory rheumatic diseases
* severe psychiatric illness and other diseases that prevent physical loading
* pregnancy
Effect of Supplementary Dietary Protein (21g Per Day) on Lean Mass and Strength in Sedentary, Adult Vegetarians

It is possible that the lower protein intake in vegetarians and vegans may relate to a decrease in grip strength. Furthermore, there is limited research examining the effects of plant-based protein intake on strength and LBM independent of an exercise training component. The present study was designed to examine relationships between strength, protein intake, and LBM in underactive vegetarian and vegan adults, as well as the impact of protein supplementation (18 g mung bean protein daily) on these indices.

The American Dietetic Association states that based off of evidence, it is possible for a vegetarian to obtain the recommended amount of nutrients with a properly planned diet. By mixing various sources of plant proteins throughout the day, a person can obtain all the amino acids needed for growth and tissue maintenance and repair. Yet, many vegetarians struggle to eat a substantial diet, especially when it comes to protein. This is because plant protein has protein bioavailability that is 10-30% lower than animal protein. As a result, current research suggests that there needs to be a separate protein dietary reference intake (DRI) for vegetarians and it needs to be larger than the protein DRI for omnivores. Whenever considering protein bioavailability, the quality must be assessed by analyzing the digestibility, chemical integrity, and freedom from interference in metabolism of the amino acid. This is a major concern because inadequate protein intake can affect bone health and alter muscle mass. Importantly, research has shown as a result of inadequate protein intake, vegetarians tend to have less lean body mass and less muscle strength than omnivores. Currently, all research available on this topic included strength training as a variable for increasing lean muscle mass, and no research has been reported that analyzed the impact of increased dietary protein on lean body mass without a training component. This parallel arm study will examine the effect of supplemental plant protein on strength and lean body mass in adult, non-athletic vegetarians in the Phoenix area.

Eligibility Criteria:
Inclusion Criteria:

* vegetarian or vegan for at least one year
* healthy by self-report

Exclusion Criteria:

* supplement use such as protein powder or creatine
* previous diagnosis of heart disease, cancer, stroke, diabetes, autoimmune disorders, or thyroid condition
* competition in any athletic event in the past year
* moderate to strenuous exercise exceeding 150 minutes per week
* pregnant or planning to become pregnant.
Osteoporosis and Dental Implant

The purpose of this study is to evaluate the influence of alendronate therapy on the wound healing after dental implants in patients with osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women \> 2 years after menopause
* Age between 60 and 75 years
* Possibility to insert a dental implant
* Osteoporosis as defined by WHO criteria (intervention group), or women without osteoporosis / osteopenia (non-intervention group)

Exclusion Criteria:

* Pathological findings in the jaw bone
* Chronic inflammatory rheumatoid disease
* Bisphosphonate treatments during the last 12 months
* Inflammatory or metabolic bone disease, excluding osteoporosis
* Systemic corticosteroid treatments of more than one month within previous 12 months
* Severe diseases with life expectancy less than one year or expectation of rapid worsening within one year
Pulmonary Embolism: Mechanism and Therapeutic Innovation

To explore the pathogenesis, therapy and outcome of pulmonary embolism (PE) and chronic thromboembolic pulmonary hypertension (CTEPH).

The study recruited consecutive outpatients or hospitalized patients diagnosed with pulmonary embolism (PE cohort) and chronic thromboembolic pulmonary hypertension (CTEPH cohort). The follow-up of all patients was performed annually by phone or outpatient visit. The main outcomes were bleeding, recurrent events, and survival. The objective of the study was to explore the pathogenesis, therapy and outcome of PE and CTEPH.

Eligibility Criteria:
Inclusion Criteria:

* All hospitalized patients or outpatients diagnosed with PE or CTEPH;
* Age ≥18.

Exclusion Criteria:

* Refused informed consents.
Treatment of Screen-detected Celiac Disease

The main purpose of this study is to evaluate the natural history of celiac disease in asymptomatic, screen-detected subjects having positive endomysial antibodies and the effects of an intervention with a gluten-free diet. The investigators hypothesize that these subjects may have decreased general health and benefit of the dietary treatment regardless of the small-bowel mucosal structure.

Asymptomatic, endomysial-antibody positive adults will be randomized to either continue with a normal, gluten-containing diet or start an intervention with a gluten-free diet irrespective of the small-bowel mucosal morphology. Several celiac-disease associated histological, serological and clinical markers will be evaluated both at baseline and after one year on trial.

Eligibility Criteria:
Inclusion Criteria:

* Positive endomysial antibodies
* Adults

Exclusion Criteria:

* Previous celiac disease diagnosis
* Significant clinical symptoms
* Suspicion of any serious celiac disease-associated complication
* Suspected or diagnosed severe illness other than celiac disease
* Consuming oral corticosteroids or immune suppressants
* Marked laboratory abnormalities
Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients

The primary objective of the study is to evaluate changes in weight short and long term with bifeprunox and quetiapine. Study participation for the subject is 57 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Schizophrenia
* 18-65 years
* No hospitalization for an exacerbation of schizophrenia within two months prior to screening and during the screening period

Exclusion Criteria:

* Subjects who are acutely psychotic or subjects with current Axis I primary psychiatric diagnosis other than schizophrenia
* At significant risk of suicide, and the potential for violent behavior (likely to harm themselves or others) based on history
High Frequency Percussive Ventilation in COVID-19 Patients

High frequency percussive ventilation (HFPV) is used in patients with underlying pulmonary atelectasis, excessive airway secretions, and respiratory failure. HFPV is a non-continuous form of high-frequency ventilation delivered by a pneumatic device that provides small bursts of sub-physiological tidal breaths at a frequency of 60-600 cycles/minute superimposed on a patient's breathing cycle. The high-frequency breaths create shear forces causing dislodgement of the airway secretions. Furthermore, the HFPV breath cycle has an asymmetrical flow pattern characterized by larger expiratory flow rates, which may propel the airway secretions towards the central airway. In addition, the applied positive pressure recruits the lung units, resulting in a more homogeneous distribution of ventilation and improved gas exchange. In acute care and critical care settings, HFPV intervention is used in a range of patients, from spontaneously breathing patients to those receiving invasive mechanical ventilation where HFPV breaths can be superimposed on a patient's breathing cycle or superimposed on breaths delivered by a mechanical ventilator. The most common indications for HFPV use are reported as removal of excessive bronchial secretions, improving gas exchange, and recruitment of atelectatic lung segments. This study aims to assess the lung physiological response to HFPV in terms of aeration and ventilation distribution in patients with acute respiratory failure due to SARS-CoV-2 infection and requiring high flow oxygen therapy through nasal cannula


Eligibility Criteria:
Inclusion Criteria:

* acute respiratory failure with a nasal swab positive for SARS-CoV-2
* need for high-flow oxygen through nasal cannula

Exclusion Criteria:

* life threatening cardiac arrythmia
* pneumothorax
* acute spinal injury
* chest trauma
* hemodynamic instability
* chest or abdominal surgery in the previous 7 days
* pregnancy
* enrollment in other study protocols