cyrilzakka/clinical-trials huggingface dataset:
Percutaneous Nephrolithotomy: A Registry and Database

Kidney stones vary in size from a tiny grain of sand to as large as filling the inside of the kidney. Treatment decisions depend on the size, location, and composition of the stone. Some kidney stones can be treated with lithotripsy (breaking up stones inside the body with shock waves created outside the body) or ureteroscopy (placing a small telescope up the urine channel to remove the stone). When stones are large in size or in the lower part of the kidney, a percutaneous (making a passage from the back into the kidney) procedure has been found to be the best method to remove the stones safely and efficiently. A passage is made into the back to allow a small telescope to see the stone and break it into fragments for removal. A small catheter is placed at the end of the procedure to allow the kidney to drain.

The purpose of this study is to record information about your surgery into a database so we can look at how patients who have had this procedure have done over time. We hope that reporting the outcomes of this surgery will be helpful to urologists and patients in the future. There may be certain factors that can be identified through this study as having better outcomes that may help make future surgeries safer.

Patients of IU Health Physicians Urology who have been scheduled to undergo percutaneous removal of one or more kidney stones will be asked to consent to be part of our registry and database for percutaneous procedures. The database contains information about the subjects surgery, such as stone size and location, number of access sites to remove the stone, length of stay in the hospital, secondary procedures, etc. This information is reviewed periodically to look for trends so that physicians may find ways to improve the percutaneous procedure. All information in the database is kept confidential. Data is collected at follow-up appointments at one month and one year to see if the subject is still stone free.

Eligibility Criteria:
INCLUSION CRITERIA:

* Patients of Methodist Urology in Indianapolis, IN
* Male or female patients with upper urinary tract stone disease appropriate for percutaneous removal as determined by a Methodist Urology physician

EXCLUSION CRITERIA:

* Patients unable to give informed consent
* Patients with active bleeding diatheses
* Women who are pregnant or in whom pregnancy status cannot be confirmed
Biomarkers in Tumor Samples From Younger Patients With Neuroblastoma

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in tumor samples from younger patients with neuroblastoma.

OBJECTIVES:

* To determine the expression of UBE4B, hrs, and members of the ubiquitination protein complex in previously banked primary neuroblastoma tumor samples from the Children's Oncology Group.
* To determine the correlation of expression levels and cellular localization of the UBE4B and hrs proteins with growth factor-receptor tumor cell-surface expression.
* To determine the 1p36 deletion status by fluorescence in situ hybridization (FISH) analysis and their association with expression levels of UBE4B and hrs in previously banked primary neuroblastoma tumor samples from the Children's Oncology Group.

OUTLINE: Banked tumor tissue samples are analyzed for expression of UBE4B, hrs, members of the ubiquitination protein complex, growth factor receptors, and 1p36 deletion status by immunohistochemistry (IHC), fluorescent microscopy, and fluorescence in situ hybridization (FISH).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Tumor tissue microarrays from the Children's Oncology Group neuroblastoma tumor bank

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Online Primary Care Physician (PCP) Training in Screening, Brief Intervention, Referral, and Treatment

This project seeks to develop a comprehensive, computer-based education program for primary care physicians that will improve their skills in structured substance abuse screening, brief interventions, and referral and treatment (SBIRT). The investigators will develop two online education programs based on virtual patient (VP) technology. One program will include five typical, interactive, problem-solving VPs and the second will include five identical VPs except that two VPs will have been "worked" by substance abuse experts and presented as case studies. The remaining three VPs will be "unworked" (typical VPs). The investigators hypothesize that both education programs will significantly improve educational outcomes, compared to no training, as measured by a validated survey tool. A secondary hypothesis is that physicians using the "worked" (guided learning) program will achieve similar educational results as those using the typical VP approach, but will require less training time.


Eligibility Criteria:
Inclusion Criteria:

* Physician in primary care training program
* Faculty member in primary care training program

Exclusion Criteria:

* Advanced medical training in substance abuse management
Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging

The ALICIA-FA study will elucidate whether targeting atrial myocardial fibrosis identified by late gadolinium-enhanced magnetic resonance imaging (LGE-MRI) improves atrial fibrillation (AF) ablation outcomes.

Atrial fibrosis is a hallmark of the AF substrate. An accurate identification and localization of myocardial fibrosis areas prior to an ablation procedure by means of LGE-MRI might help to target atrial areas harboring AF, thereby improving ablation outcomes and reducing AF recurrences.

In order to test this hypothesis, we will conduct a randomized study comparing the isolation of pulmonary veins without fibrosis imaging (conventional ablation procedure) vs. isolation of the pulmonary veins and pathological (fibrotic) tissue with the aid of LGE-MRI. Fibrotic tissue patches will be encircled and isolated in all patients in the active arm; furthermore, LGE-MRI will be used to identify, locate and guide ablation catheter to anatomical gaps surrounding pulmonary veins in re-do procedures.

Eventually, we will identify an optimized ablation strategy in patients undergoing AF radiofrequency ablation on the basis of left atrium (LA) fibrosis characterization.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a first or subsequent ablation procedure.
* Pre-procedural 3 Tesla LGE-MRI.
* Referred for radiofrequency ablation of pulmonary veins (paroxysmal, persistent or long-standing AF).
* Signed informed consent.

Exclusion Criteria:

* Claustrophobia.
* Refusal to participate in the study.
* Presence of atrial thrombus.
* LA anteroposterior diameter \>55 mm.
* Major renal impairment.
* Contrast allergy.
* Pregnancy.
Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) Study

Since the introduction of vitrectomy in 1971, this procedure has become the third most frequently performed ophthalmic surgery. Approximately 225,000 vitrectomies are performed annually in the United States and indications continue to expand. Known long-term complications of vitrectomy are relatively few and include retinal detachment and cataract formation. Although much has been written in the literature concerning acute rises in intraocular pressure (IOP) in the immediate postoperative period, there is surprisingly little information on long term IOP outcomes after vitrectomy. A recent report by Chang given at the LXII (62) Edward Jackson Memorial Lecture hypothesized a causal relationship between vitrectomy and open-angle glaucoma (OAG) via oxidative stress exacerbated by removal of the crystalline lens. A second report by Luk and colleagues reported similar conclusions in a modified cohort. Both studies, were retrospective in nature and did not perform baseline evaluations to exclude pre-existing glaucoma. Furthermore neither study accounted for natural history. Finally, our analysis has not reproduced similar results.

The primary purpose of this study is to analyze the full spectrum of optic nerve and macular changes between vitrectomized study eyes and their non-vitrectomized fellow eyes to control for natural history. Baseline evaluations will include examination by fellowship trained retina and glaucoma specialists, fundus photography, autofluorescence, optical coherence tomography (macula and optic nerve) and automated visual field testing. At 3 month then annually for 5 years after vitrectomy surgery, the cohort will undergo similar evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Able to consent and comply for the duration of the study and imaging studies
* Media clarity sufficient for imaging studies
* No previous treatment or surgery that might confound study results in the study or fellow eye
* Pars plana vitrectomy (PPV) indicated for epiretinal membrane (ERM), macular hole (MH), vitreo-macular traction (VMT), and vitreous hemorrhage (VH)

Exclusion Criteria:

* Unable to consent and/or comply for the duration of the study and imaging studies
* History of the following conditions: Glaucoma or associated conditions, visual field defects, uveitis, age-related macular degeneration (ARMD), prior PPV for retinal detachment, retained lens or dislocated intraocular lens
* Contralateral eye status post PPV or with advanced eye disease serious enough to warrant future PPV - Contralateral eye with condition that may result in choroidal neovascular membrane
Intravitreal Anti-VEGF in Exudative AMD With Epiretinal Membranes

Study designed to evaluate the effect of significant ERM on the visual and anatomic outcomes of intravitreal anti-VEGF therapy for eAMD.

Gass in 1987 described three cases of epiretinal membrane (ERM) associated with wet macular degeneration. Since then we have seen that is not rare to find the coexistence of these entities. An ERM may produce intrinsic disorganization of the outer retina leading to persistent increased macular thickness and/or edema. This persistent edema may affect the effectiveness in the treatment of exudative age-related macular degeneration (eAMD). Therefore, this study was designed to evaluate the effect of significant ERM on the visual and anatomic outcomes of intravitreal anti-VEGF therapy for eAMD.

Eligibility Criteria:
Inclusion Criteria:

* Significant epiretinal membrane
* Anti-VEGF treatment for age-related macular degeneration

Exclusion Criteria:

* Uveitis
* Macular disorders
* Diabetic retinopathy
* Vascular occlusions
Effect of Wearing of White Coat on Patient Satisfaction in Indian Out Patient Department (OPD) Setting

Doctor's attire acts as an important criteria in setting up good relationship between patient and physician. Recent evidence as well as strong viewpoints have highlighted the possible harm of wearing a white coat. In order to get the patient's perspective on the same, this observational study is being conducted to determine the effect of wearing a white coat on patient satisfaction in an Indian setting , in patients who visit rheumatology outpatient department,in Columbia Asia Hospitals,Bangalore,India.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged equal to or greater than 18 years, attending the rheumatology OPD in Columbia Asia Hospitals,Bangalore.

Exclusion Criteria:

* Patient who have come only for diagnostic or therapeutic procedure or for second opinion.
* Patients without plan for follow up.
Transcranial Direct Current Stimulation to Enhance Cognition in Mild Cognitive Impairment

The study will examine whether the effects of computerized brain training are enhanced when training is combined with mild brain stimulation in patients with mild cognitive impairment. We hypothesize that this combination will produce greater improvements in cognitive functioning than computerized brain training alone.


Eligibility Criteria:
Inclusion Criteria:

* Aged 60 - 85 years.
* Meet diagnostic criteria for amnestic mild cognitive impairment.

Exclusion Criteria:

* Inability to provide informed consent.
* Concurrent medication likely to affect mental performance.
* Current substance use or dependence in last 3 months.
* Current active psychiatric or neurological condition
Impact of Probiotics in Modulation of Intestinal Microbiota

The investigators would study about impact of the administration of probiotics in the intestinal mucosa of patients undergoing resection colic, by evaluating cytokine profile by quantitative real time PCR. The investigators believe that patients who use probiotic preoperative would provide cytokine profile less inflammatory than those of the control group.

Samples of colorectal cancer-free mucosa derived from patients who underwent surgical resection were investigated. Quantitative real-time polymerase chain reaction (RT-qPCR) was used to determine expression levels of the following genes: IL10, IL1B, IL23A, TNF, IL12B, INFG, IL17A.

Eligibility Criteria:
Inclusion Criteria:

* if he or she were older than 18 years
* intended to undergo elective CRC resection at UFMG Hospital

Exclusion Criteria:

* Patients were excluded if they were not able to receive the probiotics seven days before the operation
* if colon resection was not performed due to changes in operation strategy, or if they discontinued probiotic use on their own or
* if they removed their consent.
Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care

A randomized controlled trial of a texting intervention to increase adherence to preventative asthma medication in four Cincinnati Children's Hospital Medical Center primary care clinics.

Our first aim is to determine the feasibility, acceptability and use of a low intensity text messaging intervention to improve adherence to inhaled corticosteroid (ICS) therapy among high risk adolescents with persistent asthma. Our second aim is to determine effect sizes of the intervention to improve adherence (As measured by electronic monitoring and self-report); clinical asthma control; and asthma related quality of life among adolescents with persistent asthma. Our third and final aim is to determine the temporal relationship between text message receipt and ICS canister actuation in order to understand mechanisms by which text messaging may increase ICS adherence.

Eligibility Criteria:
Inclusion Criteria:

* provider-diagnosed persistent asthma
* prescription of an ICS in accordance in NHLBI Expert Panel Report 3 guidelines for at least 30 days prior to enrollment
* Asthma Control Test (ACT) score less than 20 (indicating lack of current control)
* no provider-diagnosed exacerbation in the 30 days prior to enrollment
* possession of a text-enabled cell phone and a plan to keep it throughout the study period
* agreement by parents (or participants over 18 years old) to any charges levied by their cell phone carrier for text messages associated with the study if they do not have an unlimited texting plan
* speak and read English

Exclusion Criteria:

* another chronic lung disease (which would complicate measurement of asthma control)
* cognitive or psychiatric disorder that the treating clinician judges would impair study participation
* use of Advair diskus for their ICS (for which no reliable electronic monitor exists)
* current enrollment in another asthma intervention study
A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus

The main purpose of this study is to investigate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination with Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas


Eligibility Criteria:
Inclusion Criteria:

* T2DM is diagnosed for at least 12 weeks according to the diagnostic criteria of diabetes mellitus issued by the World Health Organization (WHO) in 1999 and the supplementary diagnostic criteria of WHO in 2011 (HbA1c diagnosis is recommended).
* Antidiabetic drugs that meet any of the following within 8 weeks before screening:

  * A stable dose of metformin hydrochloride monotherapy at a dose of ≥ 1500 mg/day or the maximum tolerated dose ;

    * A stable dose of metformin (≥ 1500 mg/day or the maximum tolerated dose ) in combination with SGLT2 inhibitors;

      * A stable dose of metformin (≥1500 mg/day or a maximum tolerated dose \< 1500 but ≥ 1000 mg/day) in combination with a stable daily dose of sulfonylureas.
* HbA1c ≥ 7.5% and ≤ 11% at screening (central laboratory).
* BG \< 15 mmol/L at screening (central laboratory).

Exclusion Criteria:

* Type 1 diabetes mellitus or special type of diabetes mellitus.
* Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar state within 6 months before screening, or diabetic ketosis at screening/before randomization.
* Severe chronic complications of diabetes (such as proliferative retinopathy or maculopathy, diabetic painful neuropathy, intermittent claudication, or diabetic foot) at screening or before randomization.
* History of acute or chronic pancreatitis and pancreatic injury before screening.
* History or relevant family history of medullary thyroid cancer, multiple endocrine neoplasia (MEN) 2A or 2B before screening.
* Any laboratory test indicator meeting the following criteria at screening or before randomization:
* Calcitonin level ≥ 50 ng/L (pg/mL) at screening.
* ALT ≥ 3.0 × upper limit of normal (ULN) or AST ≥ 3.0 × ULN or total bilirubin ≥ 2.0 × ULN.
* Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2, calculated using CKD-EPI equation (see Appendix 3).
* Fasting triglyceride (TG) ≥ 5.7 mmol/L or 500 mg/dL.
* Blood amylase or lipase \> 1.5 × ULN.
* Hemoglobin ≤ 100 g/L for women and ≤ 110 g/L for men.
iPad Use in Reducing Anxiety and Depression in Patients Undergoing Bone Marrow Transplant

This randomized clinical trial studies iPad use in reducing anxiety and depression in patients undergoing bone marrow transplant. A tablet device like the iPad can provide access to music, television, movies, books, and the Internet. It also contains a video conferencing system that can allow patients to communicate with family members and other members of their social support team. With these capabilities, an iPad distribution program may help lessen patient anxiety and depression during a hospital stay. Monitoring iPad use by patients may help doctors better understand how patients use their computers and tablets while in the hospital so that the software and applications of the iPad can be made more useful.

PRIMARY OBJECTIVES:

I. To evaluate the effect access to an iPad has on anxiety as measured by the Hospital Anxiety and Depression Scale.

SECONDARY OBJECTIVES:

I. Determine how computers and tablets are used by patients who have access to such devices.

OUTLINE: Participants are assigned to Group A or randomized to 1 of 2 groups (Groups B or C).

GROUP A (participants provide their own computer or tablet device): A member of the research personnel helps the participants install Netflix, Spotify, and Skype applications on their computers if they wish to do so. Participants will be given subscriptions to each application and usernames for access on days -5 to 10.

GROUP B (Apple iPad): Participants receive an iPad for days -5 to 10. Participants also receive the BuckiPad manual for instructions on how to use the iPad and Netflix, Skype, and Spotify applications. Participants are also directed to the official Apple's iPad user's manual on their device and have questions answered by research personnel on day -5.

GROUP C: Participants do not receive an iPad for days -5 to 10.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing treatment in the bone marrow transplant (BMT) unit on the 3rd floor of the James Cancer Hospital and Solove Research Institute
* Patients receiving reduced intensity chemotherapy for an allogeneic stem cell transplant

Exclusion Criteria:

* Patients who lack the visual or motor skills necessary to use a tablet device like the Apple iPad

  * Criteria for visual proficiency will be determined by asking the patient: do you have trouble reading a newspaper even with your glasses or contacts (if you wear them); if "yes", they will be excluded
  * Criteria for motor skill proficiency will be determined by asking the patient: do you have any trouble using a television remote control; if "yes", they will be excluded
* Patients who do not speak English
Assessment of Methadone Dose Taken

Proof of concept: Pilot Study

A Pilot, proof of concept, observational study with a long-term goal to develop a minimally invasive wearable Remote Medication Monitor (RMM) that provides continuous, real-time data on methadone levels in interstitial fluid (ISF). An RMM could be used as a medication adherence monitor and would allow for the physician, counselor, patient, or family member to remotely verify that a physician-prescribed dose has been taken.

The investigator will conduct a non-randomized, non-blinded, feasibility study at a single center in the United States. The study will include up to 20 subjects of an equal number of male and female adults (ages 18-70) who have a prescription for methadone for chronic pain. In Aim 1, the investigator will determine if an RMM can assess the status of taking a prescribed dose of methadone, using biosamples (i.e., ISF, blood) collected from subjects and tested in a laboratory setup. Biosample collections and pharmacokinetic monitoring will take up to 6 consecutive hours. By completing this aim, the investigator will determine if a physician is able to recognize the peak and trough of a methadone dose using ex vivo Continuous Monitor.

In Aim 2, the investigator will determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time, by inserting the intradermal microneedle sensing elements into the subjects' skin. Biosample collections (i.e., ISF, blood) and pharmacokinetic monitoring will occur over a 6-hour period. By completing this aim, the investigator will determine if a physician is able to recognize the pharmacokinetic profile of a taken dose of methadone. The physician will see a dosing curve display generated from intradermal microneedle sensing elements that are worn continuously on the skin. Completion of Aims 1-2 will require two separate visits.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70
* A prescription for methadone for chronic pain at a dose of 10mg or more for at least one week.
* Taking methadone as prescribed during the last 4 days before consent to participate in the study.

Exclusion Criteria:

* Age \<18 or \>70
* A condition preventing or complicating ISF collection
* dermatological (skin) condition
* immunodeficiency
* recent blood donation
* anemia
* end stage renal disease
* liver cirrhosis
* cancer
* congestive heart failure
* bleeding diathesis
* tuberculosis (TB)
* Any active severe depression
* suicidal ideation
* mania symptoms
* Pregnancy
* Intending to become pregnant during the course of the study
* Enrolled in a substance use disorder treatment program
* Under a conservatorship.