cyrilzakka/clinical-trials huggingface dataset:
Diabetes Health Enhancement Program to Improve Health of People With Diabetes

Management of chronic diseases, such as diabetes, relies upon the health care providers and the patients self-care. Self management programs for diabetes that target self-empowerment tools have been found to be effective in some studies, but have not typically included individuals on Medicaid.

Our goal for this trial was to observe if patients participating in such a program could decrease glycated hemoglobin levels, improve health status and improve self-care practices.

Design, Setting and Population: A Phase 3, one year prospective trial, randomized to intervention or control (usual care) with Medicaid or dual-Medicare beneficiaries, with diabetes, aged 40-85 years old residing in South King County, Washington.

Intervention: A targeted, multi-component, self-management program incorporating a stage-of-change approach to overcome barriers and facilitate life-style behavior changes to achieve patient-driven health action plans for nutrition or exercise goals.

Main Outcome Measures: Glycemic control (HbA1c), physical and mental health, self-care practices.

Recruitment Status: Completed: participants are no longer being recruited; data analysis is complete.

Eligibility Criteria:
Inclusion Criteria:

* Insured under Medicaid (SSI) or dual enrolled under Medicaid and Medicare for at least one year
* Diagnosed type 1 or type 2 diabetes for at least 1 year (\>1 inpatient or \>2 outpatients visits with ICD-9 codes 250.00-250.9x, or prescriptions for insulin and/or oral hyperglycemic medications)
* Aged 40-85 years
* Geographically close to the Southeast Senior Center in South King County, Washington, and have a primary care provider (not HMO).

Exclusion Criteria:

* Serious kidney disease (serum creatinine \>2.5 or end-stage renal disease)
* Other serious illness that would preclude one-year study participation (dementia, terminal illness, organ transplantation)
* Pregnancy
* Inability to given informed consent.
Kidney Uptake at F-18 FDG PET/CT Studies and Renal Function Status

Searching for a possible correlation between renal uptake at F-18-FDG PET/CT and renal functional parameters in both normal subjects and patients with CKD.

F-18-Fluoro-Deoxy-Glucose Positron Emission Tomography (F-18 FDG PET/CT) is a hybrid imaging modality that in the last few years has been gaining more attention, due to its ability for evaluation different conditions, both neoplastic or benign. In the urinary tract, FDG is filtered by the glomerulus and is not reabsorbed by the renal tubules. So, significant activity may be displayed in any part of the urinary tract. Chronic kidney disease is highly prevalent and associated with higher cardiovascular risk. CKD is diagnosed when an estimated glomerular filtration rate (EGFR) lower than 60 mL/min/1.73 m2 present for at least three months or by alteration in the renal structure\[3\]. The Kidney Disease: Improving Global Outcomes (KDIGO) CKD guidelines recommend use of the EGFR for determination of the disease because of its simplicity, cost-effectiveness, and accuracy in predicting renal function in standard conditions. The estimating equation for the assessment of EGFR in adults is the CKD Epidemiology Collaboration (CKD-EPI).

In some cases, it has been reported that the impairment of renal function doesn't significantly compromise the clearance of background activity of F-18-FDG. In contrast, other papers observed that CKD patients have a higher physiological tracer uptake in the liver and blood pool. Different studies investigated the ability of CKD in modification of the F-18-FDG uptake during a PET/CT scan have also been published with contradictory results.

Therefore, we search for the association between renal uptake at F-18-FDG PET/CT and renal functional parameters in both normal subjects and CKD patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing PET/CT examination for oncologic or non-oncologic purposes.

Exclusion Criteria:

* Patients underwent PET/CT examination with age under 18 years.
* Presence of pathological conditions affecting kidneys (e.g., cancers, inflammation, polycystic kidney disease)
* Inability to stay still for the duration of the scan.
* Claustrophobia.
* Patients with uncontrolled diabetics (blood glucose \>200 mg/dl immediately before PET/CT scan)
* Pregnant females.
Impact of Bilingual Prescription Medication Labels Among Elderly Singaporeans

The proposed study aims to provide preliminary data that will enable the conduct of a larger Randomized Controlled Trial (RCT) on the impact of bilingual Prescription Medication Labels (PMLs) on 3 medication-related outcomes - medication adherence, medication management self-efficacy, and PML understanding.

The investigators will randomize 40 patients to Pilot Trial A or Pilot Trial B. Those in Pilot Trial A will be further randomized to Bilingual PMLs (intervention arm) or English PMLs (usual care arm) at 2 weeks post-recruitment, after assessing baseline level of the 3 medication-related outcomes; trial outcomes: difference in change, from baseline to 2 weeks post-randomization, in the 3 medication-related outcomes between the 2 arms. Those in Pilot Trial B will be further randomized to Bilingual PMLs or English PMLs immediately post-recruitment; trial outcomes: difference, at 2 weeks post-randomization, in the 3 medication-related outcomes between the 2 arms. This formative study will (1) assess the feasibility of administering the intervention, (2) refine protocols for study participant recruitment, engagement and retention, and (3) gain experience with and refine measurement of the outcomes for evaluating the intervention. The conduct of 2 pilot trials will allow us to choose the optimal trial design and determine variability.

Eligibility Criteria:
Inclusion Criteria:

* Singapore citizen/permanent resident
* Aged 50 years and above
* Just received a new (i.e., not received before) oral medication for a chronic disease
* No moderate/severe cognitive impairment (5 or more correct responses on the Abbreviated Mental Test, AMT)
* Not deaf (self-reported)
* No binocular presenting near vision impairment (near visual acuity, with routinely used spectacles/lenses: at least 6/15 (0.40 logMAR) on the Landolt's C chart)
* Able to speak at least 1 of the 4 official languages;
* Unable to read in English but able to read another official language (as they will benefit the most from bilingual PMLs)
* Assessed as non-adherent

Exclusion Criteria:

- Patients who received, from the prescribing physician, a set of instructions for their new oral medication that does not match standard instructions (as the bilingual instructions for non-standard instructions would not be prepared for beforehand)
BUPrenorphine Facilitated Access and Supportive Treatment --AIM 3

The goal of this study is to test whether peer mentors (i.e., individuals with past opioid addiction and prior incarceration) can facilitate entrance into buprenorphine (Suboxone) treatment for individuals with opioid use disorder who were recently released from jail or prison. In order to test whether it is helpful to have peer mentors paired with recently released individuals, the investigators will conduct an 18 month study, recruiting 72 formerly incarcerated individuals and assigning them by chance selection (like flipping a coin) to either a group that will receive peer mentorship or a group that will receive a referral to a community clinic.

BUPrenorphine Facilitated Access and Supportive Treatment (BUP-FAST) is a peer mentorship intervention in which trained peer mentors will link formerly incarcerated individuals with opioid use disorder to addiction treatment (i.e. buprenorphine maintenance treatment) following release from incarceration. The current study is a pilot randomized control trial evaluating the effectiveness and feasibility of the peer mentorship intervention.

The investigators are conducting this study due to the high rates of relapse to opioid use following release from prison (up to 75% within 3 months) and difficulty that some formerly incarcerated individuals report in accessing effective treatments for opioid use disorder. The investigators hypothesize that having peer mentors - who themselves have experienced incarceration and have had success with buprenorphine treatment for opioid use disorder - assisting formerly incarcerated individuals in seeking treatment will result in higher rates of linkage to care in comparison to referral to a community health center for buprenorphine treatment.

In this 18-month randomized control trial of the BUP-FAST intervention, the investigators will recruit 72 formerly incarcerated individuals with opioid use disorder; half will then be randomized to receive the BUP-FAST intervention (peer mentorship); and the other half (control) will receive referral to a community health center for assessment for buprenorphine treatment. Medication will not be provided as part of this study. Participants will only receive buprenorphine treatment if they meet appropriate medical criteria after assessment at the community health center.

Eligibility Criteria:
Inclusion Criteria:

1. Current or prior (at the time of incarceration) opioid use disorder by DSM-V criteria
2. ≥ 18 years old
3. Fluent in English or Spanish
4. Released from incarceration in the last 4 weeks

Exclusion Criteria:

1. Current buprenorphine or methadone maintenance treatment
2. Pregnancy
The Effectiveness of Vitamin C in Postoperative Pain Management of Single-level Posterior Lumbar Interbody Fusion (PLIF)

Postoperative pain management remains a major challenge for surgeons. Despite huge technological advances in pain management, many researchers have documented that unrelieved pain remains common after surgeries, which is estimated that up to 75% of patients do not achieve adequate pain relief postoperatively. The major goal in the management of postoperative pain is to minimize the dose of medications to lessen the side effects while still providing adequate analgesia, because side effects of commonly used pain medications are known to be the reasons that could lead to inadequate postoperative pain treatment. This goal is best accomplished with multimodal analgesia. One agent that can exert antinociceptive and pain reducing effects is vitamin C.

Vitamin C (ascorbic acid) is water-soluble, found throughout the body and is especially highly concentrated in the brain, which has antioxidant and neuroprotective properties. Moreover, it has been proven that the plasma vitamin C concentration decreases after surgery and the requirement for vitamin C increases in surgical patients, possibly due to greater demand caused by increased oxidative stress. Regarding the effect of vitamin C on acute pain, a result from a recent study with the aim to evaluate the potential role of vitamin C in reducing acute pain after laparoscopic cholecystectomy showed that supplementation with oral vitamin C significantly decreased morphine consumption after surgery.

Although vitamin C has potential for relieving postoperative pain, there has not been studied regarding the effectiveness of vitamin C for spine surgery, to date. This trial aimed to evaluate the effectiveness of vitamin C for surgery of lumbar spine.


Eligibility Criteria:
Inclusion Criteria:

* patients with a lumbar herniated intervertebral disc, lumbar spondylotic radiculopathy and/or myelopathy, which were diagnosed using lumbar spine radiographs and magnetic resonance images (MRI) that corresponded to clinical manifestations and physical examinations
* patients who underwent one-level PLIF
* patients who volunteered for this study with written consent
* patient who were followed-up for one year or more

Exclusion Criteria:

* fractures, infection, or tumors in the lumbar spine
* patients with hemorrhagic disorders such as hemophilia and thrombocythemia
* patient with a follow-up period of less than one year
* patients who are not suitable for this study judged by the principal investigator
A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas

This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients 18-65 years of age;
* previously untreated indolent nonfollicular non-Hodgkin's lymphoma;
* active disease;
* \>=3 involved sites.

Exclusion Criteria:

* typical chronic lymphocytic leukemia;
* other malignancies within 3 years before study, except basal or squamous cell skin cancer or cancer in situ of the cervix;
* systemic corticosteroid use for \>1 month;
* significant cardiovascular disease;
* central nervous system involvement;
* hepatitis B or C virus infection, or HIV infection.
Stuttering and Apraxia of Speech: the Efficacy of an Intervention Program

Subjects' utterances were submitted to acoustic analysis before and after the intervention program applied on prosodic basis.

The study has the aim of developing knowledge, methodology and technique in the prosody area, for its application on the speech therapy, with the assistance of a feedback system - with WinpitchPro (Philippe Martin). A database was constituted on the basis of a patterned corpus (EUROM1) by its translation, recording and editing on .wav format. Throughout model-sentences, an experimental intervention program initiates with the participation of 2 adults with stuttering problem and 2 with apraxia of speech. The efficacy of the therapeutic procedure is tested on the basis of the acoustical and the statistical analyses which have compared the first and the second speech samples taken before and after the twenty (20) therapy sessions held in a prosody approach only.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stuttering
* Clinical diagnosis of apraxia of speech
* 18 years of age or older
* Portuguese native language
* Agreement by the participant to enroll on 20 therapy sessions scheduled in a 3 month period

Exclusion Criteria:

* History of major medical illness unrelated to primary diagnosis of developmental stuttering and developmental apraxia of speech
* Significant abnormalities on general physical and neurological examination unrelated to primary diagnosis
Age-Related Eye Disease Study (AREDS)

To assess the clinical course, prognosis, and risk factors of age-related macular degeneration (AMD) and cataract.

To evaluate, in randomized clinical trials, the effects of pharmacologic doses of (1) antioxidants and zinc on the progression of AMD and (2) antioxidants on the development and progression of lens opacities.

AMD and cataract are the leading causes of visual impairment and blindness in the United States. Based on many clinical studies, it is apparent that the frequency of both diseases increases dramatically after age 60. Although excellent treatments for cataract are available, there are no equivalent treatments for AMD. As the average lifespan of our population increases, the number of people who develop AMD will increase dramatically in the years ahead. Unless successful means of prevention or treatment are developed, blindness from AMD -- and its importance as a public health problem -- will increase.

Neither the etiology nor the natural history of AMD or cataract is known. Epidemiologic studies suggest that a number of risk factors may be associated with AMD and cataract, but the strength of the evidence in support of these hypotheses varies. Possibly associated with AMD are personal characteristics, such as age, race, height, family history, and strength of hand grip; ocular characteristics, such as hyperopia and color of iris; and cardiovascular diseases, smoking, lung infections, and chemical exposures. Clinical and laboratory studies suggest the following factors may be associated with progression of AMD: drusen type, choroidal vascular diseases, and photic injury.

Epidemiologic studies of cataract suggest that associated risk factors may include personal characteristics, such as age, sex, race, occupation, and educational status; ocular characteristics, such as iris color; and diabetes mellitus, hypertension, drug exposure, smoking, and sunlight exposure. Animal studies and observational epidemiologic studies suggest that deficiencies in vitamins C and E, carotenoids, and the trace elements zinc and selenium also may be associated with the development of the two diseases, especially cataract. Although surgical treatment to remove cataract is very effective, cataract surgery carries risks, as does any other surgery. Therefore, many research efforts focus on preventing or slowing cataract development, as well as on determining the causes of cataract formation.

The Age-Related Eye Disease Study (AREDS) is a major research program to improve our understanding of the predisposing factors, clinical course, and prognostic factors of AMD and cataract. Eligible patients are randomized to treatment with placebo, antioxidants, zinc, or antioxidants plus zinc, and are followed for a minimum of 5 years.

Eligibility Criteria:
Men and women between the ages of 55 and 80 years whose macular status ranges from no evidence of AMD in either eye to relatively severe disease with vision loss in one eye but good vision in the fellow eye (20/30 or better) are eligible for the study provided that their ocular media are clear enough to allow good fundus photography.
Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery

To evaluate the differences between serum cystatin C based estimated glomerular filtration rate (eGFRcys), serum creatinine based eGFR (eGFRcreat) and measured glomerular filtration rate (mGFR) in subjects at high risk for acute kidney injury (AKI) approximately 90 days following cardiac surgery

This is an open label, single-visit study to evaluate the relationship between mGFR and eGFR based either on serum creatinine (eGFRcreat) or cystatin C (eGFRcys) approximately 90 days following cardiac surgery. No investigational study drug will be administered.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, age ≥ 45 years old
* At risk for AKI following cardiac surgery on the basis of at least one of the following pre-operatively assessed risk factors:

  1. Reduced renal function
  2. Diabetes with ongoing insulin treatment
  3. Albuminuria
* Have undergone non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest

Key Exclusion Criteria:

* Emergent surgeries, including aortic dissection, and major congenital heart defects
* Past cardiac surgery off CPB
* Have a known allergy to iohexol
Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes

This clinical study has been launched to collect spectral Raman data and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic range. The study is a combined home-based and in-clinic study where subjects will attend the clinic two times.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between 18 and 40 years of age.
* Diagnosed with type 1 diabetes mellitus.
* Uses an insulin pen or pump.
* Hb1Ac \> 55 mmol/mol at baseline visit.
* Skin phototype 1-4 according to Fitzpatrick skin tone scale.
* Willing to perform a minimum of 8 finger sticks per day during the study for the home-based study and approximately 16 finger sticks for the in-clinic study days.
* Willing to have a peripheral venous catheter inserted.
* Willing to provide written signed and dated informed consent.

Exclusion Criteria:

* Breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control according to approved contraceptives from NCA during the study execution (applicable to female subjects only).
* Subjects not able to understand and read Danish.
* Inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator.
* Subject is not able to hold hand/arm steadily (including tremors and Parkinson's Disease).
* Reduced circulation in hand. "Allen's test" is used for assessing hand circulation to evaluate occurrence of reduced blood.
* Extensive skin changes, tattoos or diseases on probe application site (thenar) that could interfere with the accuracy of the interstitial glucose measurements.
* Known allergy to medical grade alcohol.
* Having active cancer treatment and/or use tetracyclines and other medication / topical agents known to increase photosensitivity in skin.
* Medical history or any condition that may, in the opinion of the Investigator, compromise the subject's ability to participate
* Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff.
* Diagnosed with cardiovascular diseases.
* Subjects currently enrolled in another study.
* Radiotherapy for the past six months.
Efficacy and Safety of QL1206 in the Treatment of Postmenopausal Osteoporosis With High Fracture Risk

A randomized, double-blind, two-group parallel, placebo-controlled clinical Phase III trial to compare the efficacy and safety of QL1206 and placebo in postmenopausal women with osteoporosis at high risk of fracture

This is a randomized, double-blind, two-group parallel, placebo-controlled clinical Phase III trial.

The primary objective is to evaluate the effect of QL1206 treatment compared with placebo in Chinese postmenopausal women with osteoporosis at high risk of fracture.

The secondary objective is to evaluate the clinical safety, immunogenicity and pharmacokinetic (PK) characteristics of QL1206 in women with osteoporosis at high risk of postmenopausal fracture

The exploratory purpose is to evaluate the effect of ADA on the characteristics of QL1206 PK and the relationship between QL1206 exposure and pharmacodynamic endpoints, efficacy and adverse events

Subjects would sequentially enrolled according to the protocol in one of two cohorts.Subjects would receive a single 60mg of QL1206 or placebo every 6 month for1 year(twice for one, subcutaneous injection) ,meanwhile taking 500 mg of calcium and 1000IU of vitamin D daily

Eligibility Criteria:
Inclusion Criteria:

1. Subject is willing to provide written informed consent.
2. Ambulatory woman between the age of 50 and 85 years, inclusive.
3. The subject has a BMD absolute value consistent with a T-score\<-2.5 and \>-4.0 at either the lumbar spine or total hip
4. All subjects must have at least one of following additional the risk factors:history of fracture（after 40 years）,parental history of hip fracture, low Body mass index (BMI≤19kg/m\^2), elderly (age≥65year)，current smoker
5. Postmenopausal defined as \>2 years postmenopausal, which can be \>2 years of spontaneous amenorrhea or \>2 years post surgical bilateral oophorectomy.

Exclusion Criteria:

1. Bone/metabolic disease:a. Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta,which may interfere with the interpretation of the findings.

   b. Paget's disease c. Cushing's disease d. Hyperprolactinemia
2. Current hyperparathyroidism or hypoparathyroidism by medical record
3. Thyroid condition: Hyperthyroidism or hypothyroidism.
4. Rheumatoid arthritis

   -