cyrilzakka/clinical-trials huggingface dataset:
The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients

A total of 240 consecutive SLE patients fulfilling the SLICC classification criteria was evaluated. Sixty two patients who met the inclusion criteria were randomly assigned to the exercise group (n=32) or the control group (n=30).

Patients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises, of 30 minutes duration daily, for 12 weeks. Performance of daily activities was evaluated with the DASH and HAQ questionnaires, grip and pinch strength with the Jamar dynamometer and pinch gauge tools respectively, dexterity with the Purdue pegboard test and the quality of life with the LUPUSQoL questionnaire at 0, 6, 12 (end of the exercise program) and 24 weeks for both groups. SLE activity and cumulative organ damage were evaluated with the SLE disease activity index 2000 (SLEDAI-2K) and SLICC/ACR-DI, respectively.

A total of 240 consecutive SLE patients fulfilling the SLICC classification criteria was evaluated. Sixty two patients who met the inclusion criteria \[age\>18, upper limb arthralgias, and DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire score\>10)\] were randomly assigned to the exercise group (n=32) or the control group (n=30).

Patients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises, of 30 minutes duration daily, for 12 weeks. Performance of daily activities was evaluated with the DASH and HAQ questionnaires, grip and pinch strength with the Jamar dynamometer and pinch gauge tools respectively, dexterity with the Purdue pegboard test and the quality of life with the LUPUSQoL questionnaire at 0, 6, 12 (end of the exercise program) and 24 weeks for both groups. SLE activity and cumulative organ damage were evaluated with the SLE disease activity index 2000 (SLEDAI-2K) and SLICC/ACR-DI, respectively.

Eligibility Criteria:
Inclusion Criteria:

* SLE patients fulfilling the SLICC classification criteria
* Upper limb arthralgias
* DASH score\>10
* Stable drug regimen≥3 months

Exclusion Criteria:

* Hand fracture or surgery in last 6 months
* Physiotherapy program in last month
MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma (DepiSCARRH)

The purpose of this study is to assess the benefit of MR screening for asymptomatic head \& neck (or CNS) second primary cancers occurring in hereditary retinoblastoma patients previously treated by external beam radiation therapy (EBRT).

Patients with hereditary retinoblastoma treated during infancy by external beam radiation therapy (EBRT) the risk of second primary cancer occurring within radiation fields is high. The aim of this study is to depict by MRI secondary tumors as early as possible, before the occurrence of clinical symptoms. Affected patients will be further managed in a national expert center with dedicated diagnostic and treatment procedures. However, the benefit of such management has to be assessed in terms of prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Personal history of hereditary retinoblastoma (i.e., familial history of retinoblastoma, or bilateral retinoblastoma, or unilateral multifocal retinoblastoma, or identified germline RB1 mutation or 13q deletion)
* External beam radiation therapy (EBRT) used for retinoblastoma treatment
* Age at inclusion greater or equal to 7 years old.
* Time period between the end of EBRT and inclusion date of 5 years or more
* Written informed consent signed by patient (or legal representative)

Exclusion Criteria:

* Personal history of non-familial unilateral unifocal retinoblastoma without RB1 germline mutation.
* Personal history of second primary neoplasm occurring within radiation fields
* Contraindication for MRI (pacemaker, intraocular metallic foreign body, defibrillators or other implanted electronic devices, intracranial ferro-magnetic clips) or associated conditions preventing from MR examination (intraocular prostheses and implants are not a contraindication for MRI; orthodontic metallic devices are not a contraindication but might decrease the image quality and should be removed, if possible)
* Patients unable to comply with follow-up study requirements, for any geographical, social or psychological reason
The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

The purpose of this study is to evaluate the safety of vardenafil in cardiac surgery patients.


Eligibility Criteria:
Inclusion Criteria:

* undergoing cardiac surgery

Exclusion Criteria:

* emergent surgery
* recent MI in past 7 days prior to surgery
* ejection fraction \< 35%
* creatinine \> 2.0
* prior CVA
* severe COPD
* recent use of nitrates (within past 48 hours prior to surgery)
* prior CABG
* pregnancy
Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)

This study is designed to validate the performance of Masimo INVSENSOR00057 in detecting atrial fibrillation. The noninvasive ECG measurements will be compared to results obtained from an FDA-cleared ECG monitor.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older.
* Subject is confirmed to have active atrial fibrillation at the time of enrollment.

Exclusion Criteria:

* Subject is confirmed to have concurrent active arrhythmias (e.g., PVCs, bradycardia, etc.) at the time of enrollment.
* Subject is allergic to adhesives or ECG gel.
* Subject whose skin is not intact in or at the vicinity of the device placement site.
Ex Vivo Evaluation of Immunity Activation Face to S. Aureus Antigens and Adjuvants of a Vaccine Candidate in Cells From Haemodialysis Patients

S. aureus is a leading cause of severe infections notably in haemodialysis patients. These patients have a high risk of S. aureus nasal carriage, with a rate of persistent carriage near 30%. These carriers are particularly at risk of S. aureus infections as we previously shown. High risk of S. aureus infections such as bacteremia occurred notably in patients with dialysis catheters. Decolonization of carriers may prevent such infections however this approach has limits. Development of an effective S. aureus vaccine is crucial. To date, past vaccines tested (phase III) failed to achieve their end points. Target of only one or few antigens, absence of cellular response induction and possibly no impact on carriage are probably the reasons of the failures.

In an attempt to minimize failure in a clinical phase, ex vivo analysis of immune response of leucocytes of haemodialysis patients face to S. aureus and the impact of antigens and adjuvants of a candidate vaccine may help.

Eligibility Criteria:
Inclusion Criteria:

* Patient starting haemodialysis for chronic hemodialysis.
* Patient starting haemodialysis on catheter
* Patient who signed the informed consent form

Exclusion Criteria:

* Pregnant woman
* Patient who starts Haemodialysis for over 3 months
* Patient with anemia (hemoglobin \<7 g / dL)
Preventing Distracted Driving Phase II

The purpose of the study is to determine the efficacy of a smartphone app in reducing mobile phone use while driving among teens and parents. Prior to sending a message, the smartphone app informs a potential message sender that the recipient is driving.

The primary objective of this study is to determine whether the app reduces (1) smartphone communication sent from parent to teen while the teen is driving; and (2) smartphone communication sent from teen while the teen is driving. The secondary objectives are to: Determine whether the app reduces smartphone communication sent from teen to parent while parent is driving; Evaluate the acceptability of the app among parents and teens; and determine the relationship between individual differences (demographics, typical smartphone use, driving history, risk perception) and the app's efficacy.

Eligibility Criteria:
Inclusion Criteria:

Teen participants:

1. 16 to 19 years of age
2. Hold a valid driver's license
3. Own an iPhone
4. Drive at least 3 days per week

Parent/caregiver participants:

1. 18 to 75 years of age
2. Hold a valid driver's license
3. Own an iPhone
4. Drive at least 3 days per week

Exclusion Criteria:

Teen participants:

1. Non-fluency in written or spoken English

Parent/caregiver participants:

1. Non-fluency in written or spoken English
ESPBs Vs TAPs for Satisfactory Analgesia Following DIEP Surgery

Breast cancer is the second most common cancer diagnosed in American women . For patients who have undergone surgical mastectomy, autologous breast reconstruction is an alternative option to breast implants. Deep Inferior Epigastric Perforator (DIEP) flaps are the gold standard for autologous breast reconstruction . Effective pain control following surgery is imperative and ultrasound-guided bilateral transversus abdominis plane blocks (TAPs) with the infiltration of local anesthetics, such a bupivacaine are a common regional technique of choice . A newer described technique, bilateral Erector Spinae Plane blocks (ESPBs) (which also are an infiltration of local anesthetic) present as an alternative approach for post-operative analgesia. ESPBs have been proven efficacious in reducing intra- and post-operative opioid requirements, lessening the need for rescue analgesics in other similar surgical procedures.

The hypothesis is that preoperative bilateral ESPBs could provide equivalent pain control as a regional analgesic for patients undergoing DIEP flap surgery when compared to preoperative bilateral TAPs


Eligibility Criteria:
Inclusion Criteria:

* Adult women with breast cancer, ASA 1-3, undergoing DIEP flap surgery

Exclusion Criteria:

* Chronic opioid use contraindications to local anesthetics or regional analgesia Inability to communicate intensity of pain on a numeric analog scale
Retrospective Analysis of Outcomes With a Pharmacogenomic Algorithm

Antidepressants are among the most widely prescribed medications, yet only 35-45% of patients achieve remission following an initial antidepressant trial. The financial burden of treatment failures in direct treatment costs, disability, decreased productivity, and missed work may in part derive from a mismatch between optimal, and actual, medications prescribed. The present one year retrospective study seeks to evaluate the indirect and direct healthcare costs for 96 patients with a DSM-IV-TR depressive or anxiety disorder, in relation to an interpretive reporting system designed to predict antidepressant responses based on DNA variations in cytochrome P450 genes (CYP2D6, CYP2C19, CYP1A2), the serotonin transporter gene (SLC6A4), and the serotonin 2A receptor (5HTR2A) genes.


Eligibility Criteria:
Inclusion Criteria:

* Major Depressive Disorder
* Dysthymic Disorder
* Depressive Disorder NOS
* Obsessive Compulsive Disorder (OCD)
* Generalized Anxiety Disorder
* Panic Disorder
* Anxiety Disorder NOS
* Post-Traumatic Stress Disorder (PTSD)
* Social Phobia

Exclusion Criteria:

* Bipolar Disorder
* Schizophrenia
* Schizoaffective Disorder
* Previous pharmacogenomic testing
Testing the Effects of RISE on Eating Pathology

Interoception is the process of perceiving one's bodily sensations. Interoception is critical for survival and maintaining homeostasis, as it motivates sensation- and need-specific autonomic reflexes and adaptive behaviors (e.g., eating when hungry, terminating eating upon fullness, drinking when thirsty). Not all individuals have accurate interoceptive abilities. Individuals with eating disorders often have low perception of gastrointestinal, pain, and emotion sensations. Interoceptive dysfunction is believed to influence the development and maintenance of many forms of psychopathology. Identifying effective ways to restore accurate interoceptive processing is an important aim for clinical researchers. The goal of the present study is to continue to test the effectiveness of a training for interoceptive dysfunction that aims to reconnect individuals with eating disorders with their internal sensations, which is called, Reconnecting to Internal Sensations.

There are individual differences in how well people are able to recognize interoceptive sensations. Research supports a role for impaired interoception in the etiology of eating disorders (EDs), with the idea being that individuals who are out of touch with hunger and/or satiety are more vulnerable to restrictive and binge eating behaviors, respectively. Researchers have connected interoceptive impairment to self-injurious behaviors more broadly, including both direct (i.e., non-suicidal self-injury and suicide attempts) and indirect (i.e., ED behaviors) forms. The investigators have found support for the supposition that impaired interoception-or bodily disconnect-allows people to inflict pain (whether that be through ED behaviors or self-injury) upon themselves, as it is much easier to harm something one is unattached to versus something one cares for. Thus, improving interoception (e.g., helping people connect better with their bodies) may improve ED outcomes. This project seeks to test an accessible, online intervention designed to improve interoception and thereby reduce ED symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of an eating disorder
* Be a patient at the Louisville Center for Eating Disorders
* Above age 10

Exclusion Criteria:

\*Under age 10
Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI)

Study OPL-0301-201 is intended to generate efficacy and safety data of OPL-0301 in participants with post-myocardial infarction (MI) left ventricular dysfunction (LVD)

OPL-0301 is intended to address the disease state of post-myocardial infarction (MI) left ventricular dysfunction (LVD). MI is a manifestation of atherosclerotic coronary artery disease, the pathogenesis of which is closely associated with vascular and endothelial dysfunction, and inflammation. Acute MI leads to acute LVD, which often persists, leading to poor cardiovascular outcomes. The therapeutic hypothesis is that these effects mediated by Sphingosine-1 Phosphate 1 (S1P1) receptor agonism with OPL-0301 will reduce infarct size and benefit post-MI left ventricular function, thereby supporting improved cardiovascular outcomes in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Are male or female between 18 and 90 years of age, inclusive, at the time of signing the informed consent
* Are hospitalized with acute ST-Elevated Myocardial Infarction (STEMI), defined based on American Heart Association (AHA)/American College of Cardiology (ACC) criteria
* Have cardiac troponin-I (cTnI), cardiac troponin-T (cTnT) levels ≥10x upper limit of normal (ULN) at least once during the index event of myocardial infarction

Exclusion Criteria:

* Previous history of documented myocardial infarction
* Previous history of percutaneous coronary intervention (PCI) within 6 months or coronary artery bypass graft surgery (CABG) or valvular heart surgery at any time prior to screening
* Previous history of documented chronic left ventricular dysfunction with ejection fraction (EF) \< 50%
* Previous history of decompensated heart failure
* Previous history of documented specific cardiomyopathy (including but not limited to hypertrophic cardiomyopathy (HCM), amyloid, sarcoid, etc.)
* Previous history of documented arrhythmias
* Are being treated with Sphingosine-1 Phosphate (S1P) modulators (fingolimod, siponimod, ozanimod, ponesimod)
Evaluation of the Safety and Efficacy of Late-onset Pompe Disease Gene Therapy Drug

This study is being conducted to evaluate the safety and effectiveness of GC301 adeno-associated virus vector expressing codon-optimized human acid alpha-glucosidase (GAA) as potential gene therapy for Pompe disease. Patients diagnosed with late-onset Pompe disease （LOPD） who are ≥ 6 years old will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 6 years, males or females;
* Patient has a diagnosis of LOPD;
* Patient has upright FVC ≥ 30% of predicted normal value;
* A 6MWT ≥ 40 meters, assistive device allowed;
* The patient's legal guardian(s) must be able to understand the purpose and risks of the study and voluntarily provide signed and dated informed consent prior to any study-related procedures being performed.

Exclusion Criteria:

* Patient who has any history or concurrent clinical organic disease, including cardiovascular and liver diseases, respiratory system, nervous system disease, or any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study.
* Patient who requires invasive mechanical ventilation, or rely on noninvasive non-non-invasive assisted ventilation when sitting upright;
* Patient who is positive for human immunodeficiency (HIV) antibody, hepatitis B surface antigen, hepatitis C antibody, or treponema pallidum antibody;
* Patient with a history of glucocorticoid allergy;
* Patient who has a contraindication to study drug or to corticosteroids, or has demonstrated hypersensitivity to any of the components of the study drug;
* Patient who has AAV9 neutralizing antibody titer ≥ 1:100；
* Patient who has participated in a previous gene therapy research trial;
* Pregnant or lactating female participants;
* Patients who have fertility plans within 6 months from screening to the end of the study and are unwilling to take effective physical contraceptive measures (such as a condom, intrauterine device, contraceptive ring, ligation, abstinence, etc.) for contraception (including the subject's partner);
Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)

This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.


Eligibility Criteria:
Inclusion Criteria:

* Adults, 18-65 years old
* One or more mild-moderate TBI's characterized by loss of consciousness due to blast injury that is a minimum of one year old and occurred after 9/11/2001
* Absence of acute cardiac arrest or hemorrhagic shock at time of TBI.
* Absence of intracranial neurosurgery post-TBI
* Disability Rating Scale of 0-3
* Negative Michigan Alcohol Screening Test (MAST)
* Negative Drug Abuse Screening Test (DAST)
* Negative urine toxicology screen for drugs of abuse
* Negative pregnancy test in females
* Otherwise good health
* Less than 90% on the Percent Back to Normal Rating Scale

Exclusion Criteria:

* Pulmonary disease that precludes HBOT
* Unstable medical conditions that are contraindicated in HBOT
* Severe confinement anxiety
* Pregnancy
* Other pre-TBI neurological diagnoses
* Pre or post TBI history of substance abuse
* Pre or post TBI history of alcoholism.
* Participation in another experimental trial with active intervention.
* High probability of inability to complete the experimental protocol.
* Previous HBOT
* History of hospitalization for past TBI, stroke, nonfebrile seizures, or any seizure history other than seizure at the time of TBI
* Past or current history of mental retardation (baseline FSIQ \< 71.
* Pre/post-TBI history of systemic illness with impact on CNS (P.I.'s decision)
Proprioception on Balance and Gait in Hemiparetics

The loss of sensorial feedback causes gait impairment in hemiparesis. The studies show that proprioceptive impairment of knee is related to falling in these patients. The aim of this study is to investigate the effects of proprioception on balance and gait functions in hemiparetic individuals.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 20-65 and discharged from the hospital,
* Diagnosed with hemiparesis at least 4 weeks ago,
* First time and unilateral hemiparesis,
* Modified Rankin Score ≤ 3,
* Hodkinson Mental Test ≥ 6,
* Individuals who agree to receive treatment will be included in the study.

Exclusion Criteria:

* Having vision and hearing problems,
* Having other accompanying neurological, psychiatric and/or orthopedic problems other than hemiparesis,
* Medically unstable,
* Diseases that will affect the lower extremity sense,
* Individuals with open wounds, circulation problems, and skin lesions in the area to be treated will be excluded from the study.
Developing Novel Circulating Epigenetic Biomarkers for Early Detection of Lung Cancer

The investigators aim to identify novel circulating methylated biomarkers for early lung cancer detection as well as to develop new technologies that are clinically applicable with high sensitivity and specificity.

Lung cancer is the leading cause of cancer death, accounting for 2.09 million cases in 2018 worldwide. There is a huge demand globally for sensitive and reliable assays to intercept lung cancer at early stages when it can be cured. Past studies have shown that circulating cell-free tumor DNA (ctDNA) shed from tumor cells contains the same mutations and methylation patterns as the original tumor cells. Emerging evidence has indicated the presence of systemic immune dysregulation in cancer patients, and that tumor-reactive T cells carry a distinct molecular profile compared to other bystander cells. Thus, molecular abnormality of ctDNA and tumor-reactive T cells may be one of the early signs that hint the presence of malignancy, and it may serve as a promising target for development of blood-based assays in early lung cancer for its convenience and non-invasiveness as opposed to invasive tumor biopsy, or imaging-based methods that are limited by unsatisfactory sensitivity/specificity.

The investigators aim to identify novel markers for early lung cancer detection as well as to develop new technologies that are clinically applicable with high sensitivity and specificity. The objectives of this proposal are multifaceted: (1) The investigators will generate genome-wide methylation atlas of circulating cell free DNA and of circulating T cells in lung cancer patients vs. non-cancer subjects. (2) The investigators will develop an enriched method to enhance the performance of multiplex droplet digital PCR (ddPCR) technology with increased sensitivity and decreased input DNA requirement. (Enriched methylation-specific droplet digital PCR, EMS-ddPCR) (3) The investigators will develop a single-cell, locus-specific DNA methylation detection system that is bisulfite-free and non-PCR-based. The system can be coupled with flow cytometry or mass cytometry to enable cell-type specific methylation detection. (single-cell, locus-specific methylation detection, scLSM-FACS) (4) The investigators will identify a novel methylation signature consisting of tumor-derived and immune-derived biomarkers for early detection of lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Subjects suspected or confirmed diagnosis of lung cancer.
* Subjects who had indeterminate sub-centimeter pulmonary nodules or ground glass opacities discovered by computed tomography.
* Non-cancer subjects: including healthy volunteers and chronic inflammatory airway diseases such as chronic obstructive airway disease, asthma, and bronchiectasis, etc.
* Subjects age over 20.

Exclusion Criteria:

* Pregnancy.
* Subjects with HIV infection.
* Unable to or unwilling to give informed consent.