cyrilzakka/clinical-trials huggingface dataset:
Quality of Life Intervention to Inform Patient Decision-Making in Early-Stage Lung Cancer

This clinical trial studies the effect of a quality of life intervention on decision-making in patients with early-stage lung cancer who are undergoing standard of care surgery or stereotactic body radiation therapy (SBRT). Providing quality of life outcome data to patients deciding between surgery and SBRT may help decrease decision regret and increase patient satisfaction with their care.

PRIMARY OBJECTIVE:

I. Determine the effect of provision of quality-of-life (QOL) information versus usual care for standard of care surgery or SBRT treatment on decision regret.

SECONDARY OBJECTIVES:

I. Determine the effect of provision of QOL information versus usual care for standard of care surgery or SBRT treatment on QOL measures.

II. Determine the influence of socioeconomic status on the relationship between decision regret and QOL information associated with each treatment modality.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP A: Patients receive study QOL intervention fact sheet during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT. Patients have an opportunity to review the QOL fact sheet in person and discuss any questions with the treating physician(s).

GROUP B: Patients receive usual care during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT.

Patients are followed up at 1, 3, and 6 months after standard of care surgery or SBRT.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Radiographic stage I-II non-small cell lung cancer (NSCLC)
* Eligible for both surgery and SBRT
* Able to provide informed consent in English
* Have verbal fluency in English
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Radiographic stage III-IV NSCLC
* Eligible for either only surgery or SBRT, but not both
* Eligible for palliative-intent treatments or supportive care only.
* Pregnant female participants.
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate
* Cognitively impaired adults/adults with impaired decision-making capacity
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
Assessment of Dolutegravir Removed by Hemodialysis in HIV-infected Patients With End-stage Renal Disease

Data on the capacity of hemodialysis to remove dolutegravir (DTG) from plasma in patients with end-stage renal disease (ESRD) on hemodialysis (HD) are lacking. If DTG was removed from plasma by HD, it would be possible to have subtherapeutic drug concentrations at the end of HD sessions.

The prevalence of chronic renal disease and end-stage renal disease (ESRD) is increasing in the HIV-positive population. This means that an increasing number of HIV-infected patients will need renal replacement therapy.However, little is known about DTG removal from plasma by HD in patients with ESRD.

Objective: to evaluate the effect of HD on DTG clearance as well as on DTG plasma concentrations at steady state in HIV-infected patients with ESRD undergoing HD.

Eligibility Criteria:
Inclusion Criteria

1. Age 1 years old or older.
2. HIV documented infection (western blot)
3. ESRD undergoing routine hemodialysis
4. Stable antiretroviral treatment (no changes within the prior 2 weeks)
5. Signature of informed consent

Exclusion Criteria:

1. Inadequate adherence to antiretroviral treatment (\<90% in the week prior to inclusion).
2. Clinical evidence or suspicion that the patient will not be able to comply with the study protocol.
Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis in Intraocular Pressure (IOP) After Bevacizumab

Purpose: To evaluate the effects of anterior chamber paracentesis, brimonidine and oral acetazolamide to reduce intra-ocular pressure (IOP) variations after intravitreal bevacizumab injection (IVBV).

Methods: 47 patients scheduled for IVBV (1.5 mg / 0.06 ml) will be randomly assigned to a pre-treatment 1 hour before IVBV with either 250 mg oral acetazolamide (DIA, 9 eyes), anterior chamber paracentesis immediate after IVBV (PAR, 15 eyes), topic brimonidine tartarate 1 hour before IVBV (BRI, 14 eyes), or no pre-treatment IBVB (CTR, 9 eyes). IOP will be measured 90 minutes before injection (baseline), just before injection, and at 3, 10, 20 and 30 minutes after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* macular edema

Exclusion Criteria:

* pulmonary chronic problems
* chronic renal failure
* intraocular inflammation
* drug or alcohol addiction
A Simple Clinical Tool to Help Diagnose Pulmonary Embolism: Phase 1

The goal of this project is to determine if the change in oxygen saturation during deep inspiration ("augmented pulse oximetry") can be used as a method to rule out pulmonary embolism (PE). The investigators propose to evaluate a simple, non-invasive clinical tool to help rule out PE. The investigators plan to measure the oxygen saturation of 40 consecutive patients with newly-diagnosed PE (within 60 minutes of diagnosis) and 80 matched controls who do not have a PE. Trained, blinded Respiratory Therapists or Study Coordinators will record each patient's oxygen saturation before, during, and after a 2-minute period of deep inspirations (vital capacity \[the maximal amount of air that can be inhaled, measured in milliliters\]) using an incentive spirometer. The investigators' central hypothesis is that persons with a PE will not respond to augmented pulse oximetry and will not significantly improve or normalize their oxygen saturation.

Patients will be identified and enrolled by the Mayo Clinic St. Marys Emergency Department staff as they are undergoing medical care in the Emergency Department.

The investigators will calculate the difference in oxygen saturation pre- and post-deep inspiration (ΔSpO2 at 1 minute, 2 minutes and 4 minutes), and then correlate these values with the CT result.

In cases of PE, The investigators expect the SpO2 to remain unchanged, or to change less than 3-5%. The investigators expect alternate hypoxemic conditions to have a significantly greater increase in SpO2.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater.
* Agrees and able to participate in the study.
* Room air SpO2 (oxygen saturation) less than 92% and newly-diagnosed PE (or controls with no PE) based on CT angiogram result.

Exclusion Criteria:

* Clinical concern for instability.
* Systolic blood pressure less than 100 mm Hg.
* Heart rate ≥140 beats per minute.
* Oxygen saturation less than 85% with more than 4 L supplemental oxygen.
* Unable to participate/comply with instructions for using the incentive spirometer.
* Patients from the Federal Medical Center in Rochester, Minnesota.
* Patients who do not speak English (due to the need for expediency).

Patients will be under the care of the Emergency Department team who have the skills and resources to monitor and treat patients if they were to become unstable.
Platelet Function Analysis in Head Trauma: ASA/Plavix

The investigators are assessing the platelet function analysis of those who sustained significant head trauma while on aspirin or plavix and to assess if any qualitative difference is obtained if platelets are administered.

The platelet function analyzer VerifyNow® P2Y12 uses ADP as agonists to induce platelet activation and ascertain the level of platelet function impaired by these medications. VerifyNow® Aspirin Assay utilizes arachidonic acid as the agonist to measure platelet function specifically along this pathway. Our research question for this study is as follows:

Does the administration of desmopressin (DDAVP) and/or the transfusion of platelets in patients with head trauma reverse the platelet inhibition caused by Aspirin and/or Plavix? The investigators hypothesize that with the administration of platelets and/or DDAVP that there is a reversal of the inhibition.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18yrs
2. Must be a trauma patient with blunt head trauma.
3. Must be on Aspirin and/or Plavix
4. Subject or Legally Authorized Representative (LAR) (per Heath and Safety Code, Sections 24170 to 24179.5) must sign study consent within 4 hours from the first blood draw. (If this criterion is not met the initial blood draw must be destroyed and NOT run for study results).

Exclusion Criteria:

1. Hemoglobin ≤ 10 GM/DL
2. Platelet Count ≤ 150 K/MCL
3. Pregnant Females
4. Subjects on Warfarin, Heparin or Enoxaparin
Assessment of the Validity, Reliability, and Feasibility of Two Smartphone Applications for Testing the Visual Acuity

Visual acuity (VA) is the most common measure of visual function globally. In clinical settings and during screening events, VA is an important measure to quantify changes in vision over time. Additionally, in the context of epidemiological studies and population-based surveys, VA is a critical measure to determine the presence and degree of vision impairment and to report on the indicators of effective eye care service coverage (i.e. refractive error and cataract surgery), that are currently considered by World Health Organization (WHO) for monitoring progress towards the Universal Health Coverage.

There are numerous applications for assessing VA; however, the number of validated applications is limited. In this study, the investigators aim to evaluate the external validity, intra- and inter-observer reliability, and feasibility of two applications ("Easy Vision" and "Peek Acuity") for testing the visual acuity.


Eligibility Criteria:
Inclusion criteria:

• Age ≥10 years old

Exclusion criteria:

• Subjects who are not able to respond to the examiner
Core Stabilization Exercises in Patients with Knee Osteoarthritis

Exercise plays a key role in the treatment of knee osteoarthritis, but there is no clear evidence on which type of exercise is most effective. Recent studies highlight the benefits of core stabilization exercises for improving knee stability. This study aims to demonstrate the effects of adding core stabilization exercises to conventional exercise therapy for patients with knee osteoarthritis.

Knee osteoarthritis is becoming a significant public health problem with the aging population. While there is no definitive cure, exercise is the main approach to treatment. Various types of exercises are being studied for their effectiveness in osteoarthritis treatment, and recently, core stabilization exercises have been highlighted for their role in lower extremity pathologies. In this study, we aimed to investigate the effects of these exercises on pain, balance, quality of life, function, and quadriceps muscle thickness in patients with knee osteoarthritis.

This study was designed as a randomized controlled double-blind clinical trial. Thirty-two patients were randomly divided into two groups: a conventional exercise group and a conventional+core group. A total of 18 home exercise sessions, performed three times per week for six weeks, were planned.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bilateral stage II or III knee osteoarthritis according to the Kellgren and Lawrence grading system
* Aged between 50 and 65 years
* Having a complaint of knee pain for at least 6 months
* No systemic diseases that may hinder exercise (such as uncontrolled hypertension, cardiac arrhythmia, heart failure, neurological sequelae, joint deformities, malignancy, etc.)

Exclusion Criteria:

* Having received physical therapy in the last 6 months
* Having undergone knee injection in the last 6 months
* Having had knee surgery
* Morbid obesity
* Presence or history of malignancy
* Individuals with severe visual impairment
* Individuals with a history of neurological or vestibular diseases that could cause balance problems, or patients using medications that may affect balance
* Individuals with serious cardiac, respiratory, or uncontrolled metabolic diseases
Study to Assess Fixed Dosing of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia

The primary objectives of this study are the following:

1. To demonstrate that AMG 223 will produce a statistically significant reduction in serum phosphorus compared with placebo over a 3 week treatment period in subjects with CKD receiving dialysis
2. To describe a dose response for AMG 223
3. To evaluate the safety and tolerability of AMG 223


Eligibility Criteria:
Inclusion Criteria:

* Maintenance hemodialysis 3 times a week for at least 3 months prior to screening
* Single pool Kt/V at least 1.2 or urea reduction ratio at least 65%
* Serum phosphorus level of 3.5 to 6.5 mg/dL inclusive at screening
* No change(s) in type or dose of non-investigational phosphate binder(s) for at least 1 month prior to screening
* Serum albumin \> 3.0 mg/dL at screening
* If applicable, an increase in serum phosphorus of greater than or equal to 1.5 mg/dL, and a serum phophorous level \> 5.5 mg/dL and less than or equal to 10 mg/dl during the washout period
* If applicable, stable doses (defined as no change in dose for at least 1 month prior to screening) of Vitamin D replacement, calcimimetic agents, or bedtime calcium supplements
* Willingness to avoid intentional changes in diet such as fasting or dieting

Exclusion Criteria:

* Previous intolerance leading to discontinuation of polymer-based phosphate binder therapy
* History of noncompliance with phosphate binder therapy in the opinion of the investigator
* Anticipating or scheduled for a living related-donor kidney transplant, or a prior recipient of a kidney transplant
* Current use of antiarrhythmic or anti-seizure medication
* Active ethanol or drug dependence or abuse, excluding tobacco use
* A screening serum calcium (corrected for albumin) \< 8.4 mg/dL
* History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders, major gastrointestinal surgery, or gastric/duodenal ulcers within 6 months prior to screening
* Subject is pregnant, breast feeding, or is of child bearing potential and is not using adequate contraceptive precautions
* Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s)
* Subject has experienced a myocardial infarction or major surgery (excluding vascular access surgery) within 3 months prior to screening
* Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of localized basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia
Vitamin D and Inflammatory Markers of Cardiovascular Disease in African Americans With Type 2 Diabetes

Recent clinical trials in non diabetics showed that vitamin D supplementation markedly reduced serum levels of C-reactive protein (CRP), interleukin-6, and tissue matrix metallo-proteinases. Our study objective is to evaluate if administration of vitamin D in African Americans with hypovitaminosis D and DM Type 2 decreases serum levels of inflammatory/thrombotic markers such as CRP: Highly Sensitive C Reactive Protein.

Other questions in our study: In diabetic African American patients,

1. Prevalence of vitamin D deficiency?
2. Correlation/relationship between vitamin D levels, Calcium level, parathyroid hormone (PTH) and Inflammatory markers

Setting: All visits will take place at the Fantus Diabetes Clinic.

Eligibility Criteria:
Inclusion Criteria:

* African Americans
* DM type 2

Exclusion Criteria:

* symptomatic vitamin D deficiency
* hypocalcemia
* hypercalcemia
* malabsorption
* liver disease
* patients with creatinine \> 1.5. (CKD \>/= 3)
* pregnancy
A Mobile App-Based Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US

The study aims to longitudinally capture the full spectrum of symptoms, treatment utilization, and overall health-related quality of life (HRQoL) experienced by Immunoglobulin A nephropathy (IgAN) patients and their caregivers.

This will be a prospective, observational study. Data will be collected using the Folia Health platform. Participation in the study will occur through use of the Folia mobile platform, where study participants will be directed to a study-specific platform environment to review and sign the consent form and enroll. Each participant will complete an initial 6-month study data collection period which includes home reported outcomes (HRO) tracking along with study specific components including a baseline survey, monthly check-in prompts, and endline study evaluation survey. After the 6-month period, participants can continue to use Folia to track their HROs for their own personal use. With their consent, the data they enter after the initial 6-month period may be reviewed for ongoing data integrations with Novartis APPRISE data platform for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IgAN, regardless of symptom or treatment history
* Adult aged 18 or older; adult caregiver to an adult patient aged 18 or older; or adult caregiver to a pediatric patient under 18 years of age
* US-based with a proficient understanding of and ability to read the English language

Exclusion Criteria:

None
Toujeo Versus NPH Self-titration Study

This is a 24 week, multicentre, prospective, randomized, controlled, parallel-designed (1:1) pilot study.The study will compare glycemic variability in patients treated with insulin glargine U300/ml insulin versus conventional (NPH) insulin using a self titration algorithm.50 type 2 diabetes patients who are newly started on insulin will be recruited. They will be randomly allocated to either insulin glargine U300 or NPH insulin for 26 weeks. All subjects will follow a insulin-self titration algorithm. The study will consist of 9 visits over 26 weeks. Blood glucose variability will be collected by CGM for 7 consecutive days at baseline (week -1) and at week 24.Secondary endpoints other than data on glycemic variability, including HbA1c, fasting plasma glucose, inflammatory markers will be measured during three periods (week 0, week 12 and week 24).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic suboptimally controlled on their previous antidiabetic treatment

  * 18 ≤ age ≤ 75
  * Stable dose of oral antidiabetic treatment for \> 8 weeks
  * The number of OADs that the patients used should be "3" or less
  * HbA1c level \> 7.0% and \< 10%
  * Fasting plasma glucose \> 8mmol/L and \<15mmol
  * BMI \< 40 kg/m2
  * Patient who is capable and willing to perform regular SMBG
  * Patient who is capable and willing for insulin injection
  * Confirmed written consent
  * Insulin naïve

Exclusion Criteria:

* Participation in a clinical trial with any investigational drug used with curative intent and within 30 days prior to study entry
* Patient known to have hypoglycaemia unawareness or recurrent major hypoglycaemia
* Any product containing prandial insulin
* Concomitant medication known to interface with glucose metabolism (such as systematic steroids)
* Change in dose of non-insulin anti-diabetic treatment or initiation of new anti-diabetic medications in the last 8 weeks prior to screening
* Patients treated with steroid or nonsteroidal anti-inflammatory drugs
* Patient who had experienced an acute concurrent illness during the 3-month period before the investigation
* Patient with hepatic disease and end-stage renal disease
* Patients unable to comply with follow-up visits
* Pregnant or breastfeeding women
Social Determinants of Health in Diabetes Outcomes

This is a cross-sectional study of six hundred adults with type 2 diabetes, (300 White and 300 African-American) who will be recruited from two primary care sites to determine how social determinants of health impact diabetes outcomes. The first aim is to investigate the role of psychosocial factors and SES on diabetes care processes and outcomes. The second aim is to investigate the influence of community and neighborhood characteristics on diabetes care processes and outcomes. Finally, we will examine the contribution of social determinants of health to ethnic differences in diabetes care processes and outcomes. Clinical and metabolic measures will be abstracted from the electronic medical records. Outcome variables include hemoglobin A1c, blood pressure, LDL-Cholesterol and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes
* Able to communicate in English

Exclusion Criteria:

* Mental confusion on interview suggesting significant dementia
* Alcohol or drug abuse/dependency
* Active psychosis or acute mental disorder
OC000459 Dose Finding Study in Patients With Mild to Moderate Persistent Asthma

This will be a double blind, randomised, 4 arm, parallel group, placebo controlled study of three dose levels of OC000459 tablets in patients with asthma controlled by beta agonist drugs alone. This study will compare the patients on OC000459 at three different dose levels (25mg once daily, 100mg twice daily and 200mg once daily) with patients on placebo after dosing for 17 weeks. The trial will be undertaken in an outpatient population. Each treatment arm will consist of at least 110 subjects. The objective is to assess the efficacy of these dose levels on the patients asthma.


Eligibility Criteria:
Inclusion Criteria:

* Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception
* Aged 18 to 55 years inclusive.
* Non smokers for at least the past 12 months with a pack history of less than 10 pack years.
* Mild to moderate persistent asthma according to GINA4 guidelines for at least 12 months

Exclusion criteria:

* Receipt of prescribed or over the counter medication within 14 days prior to the first study day
Fixed Dose NESP Study in Subjects With CRI

Multicenter, open-label, single-arm, fixed dose study of darbepoetin alfa in subjects with Chronic Renal Insufficiency (CRI). Subjects will be screened for 2 weeks during which time blood will be drawn and vital signs will be taken. Upon enrollment, subjects will receive SC darbepoetin alfa administered once every other week for 24 weeks. Darbepoetin alfa will be titrated in fixed-dose steps to maintain a hemoglobin of 11.0 - 13.0. During the study, laboratory assessments will be completed and vital signs will be taken. Subjects will enter a 1-week post-treatment observation and evaluation period after the last dose of study drug.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years of age
* CRI with a creatinine clearance of less than 40 mL/min
* Hemoglobin less than 11.0 g/dL
* Serum vitamin B12 and folate levels above the lower limit of normal and iron replete

Exclusion Criteria:

* Received rHuEPO therapy in the last 12 weeks
* Expected to initiate renal replacement therapy within 24 weeks or a recipient of a renal transplant
* Uncontrolled hypertension
* Seizure activity, CHF, hyperparathyroidism, major surgery, HIV-positive Pregnant or breast-feeding