cyrilzakka/clinical-trials huggingface dataset:
Testing New Models of Diabetes Self-Management to Improve Population Health

Aim 1.1 To understand if diabetes self-management education and support (DSMES) improves diabetes-related outcomes among those with Type 2 diabetes living in Texas.

Aim 1.2 To examine how rurality affects study participation, engagement in, and effectiveness of different education interventions.

These aims are based on a randomized controlled trial of different evidence-based diabetes self-management interventions.

A randomized controlled trial (RCT) was conducted to assess the outcomes associated with different technological intervention approaches. This 3-arm RCT assessed independent and combined interventions:

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (T2DM) - self-reported diagnosis by a health care provider
* HbA1c value greater than or equal to 7.5%
* Adults ages 25 years and older
* All genders
* Have access to device (smartphone/tablet which meets iOS 13 or above or similar system requirements/iPhone 7 and above or Android 6 and above) and internet in order to view online diabetes education content
* Ability to read and speak English
* Resides in Texas

Exclusion Criteria:

* Pregnant women
* Participation in ADA-recognized or AADE-accredited diabetes self-management education program lasting at least eight hours within previous six months
* Engagement with ADA-recognized or AADE-accredited smartphone application with certified diabetes educators providing tracking and health coaching within the previous six months
* Those diagnosed with any conditions listed below (determined by self-report): Liver failure, End-stage renal disease (stage 4 or 5), Congestive heart failure (grade C or D), Organ transplant or bone marrow transplant, Cystic fibrosis, Malignant neoplasm or bone marrow transplant
* Criteria excludes individuals based on language. Participants must be able to read and speak English. Technology-based education and support (TBES) is available only in English.
De Novo Lipogenesis in Severity of NAFLD

NAFLD is the most prevalent liver disease in the U.S., and there is a serious need to understand its progression to the advanced state, nonalcoholic steatohepatitis (NASH). Previous studies has shown that elevated de novo lipogenesis (DNL) is the unique, early event distinguishing patients with NAFLD from equally-obese subjects with low IHTG. The purpose of this study is to directly by measure DNL in human liver tissue and comparing it to liver histological scores from patient biopsies.

The development of nonalcoholic fatty liver disease (NAFLD) progresses from a state of elevated intrahepatic triglycerides (IHTG) to liver inflammation, and ultimately, hepatic apoptosis and fibrosis. NAFLD is the most prevalent liver disease in the U.S., and there is a serious need to understand its progression to the advanced state, nonalcoholic steatohepatitis (NASH). Elevated de novo lipogenesis (DNL) is the unique, early event distinguishing patients with NAFLD from equally-obese participants with low IHTG. DNL is the process of liver synthesis of fatty acids (FAs) from carbohydrate. In humans, studies have shown that DNL significantly predicts the magnitude of IHTG, however, it is unknown whether the pathway plays a role in disease progression. Evidence supporting this concept includes the fact that the primary product of DNL is the saturated FA, palmitate, which in cell culture has been shown to significantly contribute to oxidative stress and inflammation. Recent rodent data show that upregulation of DNL through dietary supplementation of sucrose exacerbated the hepatotoxic effects of excess dietary FAs. A preliminary abstract presented by others at the 2017 Liver Meeting suggested that DNL may not be different between patients with low and high liver fibrosis, although these data were collected using an indirect measure of liver disease. Here, in the present study, the hypothesis will be tested directly by measuring DNL in human liver tissue and comparing it to liver histological scores (NAFLD Activity Score, NAS) from patient samples.

Eligibility Criteria:
Inclusion and exclusion criteria are similar to the criteria set by a larger project (NCT03151798).

Inclusion criteria:

* Men and women (pre and post-menopausal)
* Overweight/obese with BMI ≥ 25.9 or ≤ 50.0 kg/m2
* Characteristics of the metabolic syndrome, pre-diabetes (fasting glucose 100-125 mg/dL or 2h glucose 140-200 mg/dL) or diabetes type II
* 22-65 years of age
* use of tobacco products or no use of these products
* Sedentary, ≤ 60 minutes per week of structured physical activity

Exclusion criteria:

• The following conditions exclude subjects for this project because bariatric surgery would not be performed in these populations. Individuals with acute disease or advanced cardiac, liver, or renal disease, excessive alcohol use, anticoagulation therapy, or any severe co-morbid condition limiting life expectancy \< 1 year. Women pregnant or trying to become pregnant.
A Trial to Assess the Effect of an Intervention Integrating Contingency Management (Financial Incentives) to Enhance Hepatitis C Treatment Uptake Following Dried Blood Spot Hepatitis C RNA Testing Among People With Recent Injecting Drug Use Attending Needle and Syringe Programs

A pilot two-arm, individual-level, randomised controlled trial to assess the effect of an intervention integrating contingency management (financial incentives) to enhance hepatitis C treatment uptake following dried blood spot hepatitis C RNA testing among people with recent injecting drug use attending needle and syringe programs: the AMPLIFY study


Eligibility Criteria:
Inclusion Criteria:

1. Participants have voluntarily signed the informed consent form
2. 18 years of age or older
3. Recent injecting drug use (previous six months)

Exclusion Criteria:

1) Inability or unwillingness to provide informed consent
Paclitaxel in Treating Patients With Recurrent or Persistent Cancer of the Uterus

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or persistent cancer of the uterus.

OBJECTIVES: I. Estimate the antitumor activity of paclitaxel in patients with metastatic or persistent leiomyosarcoma of the uterus who have failed treatment protocols of higher priority. II. Determine the nature and degree of toxic effects of paclitaxel in this group of patients.

OUTLINE: Patients receive a continuous infusion of paclitaxel once every 3 weeks over 3 hours. Patients in complete remission, partial remission, or stable disease undergo at least 3 courses of paclitaxel. Paclitaxel continues until disease progression or adverse effects prohibit further treatment. All patients are followed until death.

PROJECTED ACCRUAL: This study anticipates an annual accrual of approximately 25 patients over 2.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent uterine leiomyosarcoma that is refractory to curative therapy or established treatments Measurable disease required Must have failed local therapeutic measures and must be considered incurable Not eligible for GOG protocols of higher priority

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-3 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT and alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No unstable angina within 6 months OR No myocardial infarction within 6 months Abnormal cardiac condition (e.g., bundle branch block, heart block) allowed if stable for 6 months Other: No significant infection No concomitant malignancy other than nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: At least 3 weeks since prior therapy to malignant tumor Biologic therapy: Not specified Chemotherapy: Recovery from prior chemotherapy required No more than 1 prior chemotherapy regimen allowed No prior paclitaxel No prior chemotherapy for any malignancy from which the patient is disease-free for at least 5 years Endocrine therapy: Not specified Radiotherapy: Recovery from prior radiation therapy required No prior radiation therapy for any malignancy from which the patient is disease-free for at least 5 years Surgery: Recovery from prior surgery required
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of UB-221 as an add-on therapy in patients with Chronic Spontaneous Urticaria.

This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of UB-221 as an add-on therapy in patients with Chronic Spontaneous Urticaria.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with age between 20 to 65 years old (inclusive).
* Subjects who are able and willing to provide the informed consent.
* Male subjects with body weight of 50 kilogram (kg) or above; female subjects body weight of 45 kilogram (kg) or above.
* Subjects diagnosed with chronic spontaneous urticaria (CSU).

Exclusion Criteria:

* History of significant diseases (other than CSU) or major clinical conditions by the investigator's judgment, such as auto-immune disease or psychiatric and behavioral conditions from which the investigator considers the subject is not suitable to participate in this study.
Unscheduled Hospital Readmission After Crenel Lateral Interbody Fusion

The goal of this observational study is to learn about the readmission related to Crenel Lateral Interbody Fusion (CLIF). The main question it aims to answer is:

What are the risk factors for readmission after CLIF surgery?


Eligibility Criteria:
Inclusion Criteria:

* Patients with spinal degeneration undergoing CLIF surgery

Exclusion Criteria:

* Under the age of 18
Circadian Disturbances After Breast Cancer Surgery

The purpose of this study is to investigate circadian disturbances after breast cancer surgery by means of monitoring sleep and heart-rate variability, by measuring a metabolite of melatonin in urine and by questionnaires and a sleep-diary.

An increasing number of studies have shown that circadian variation in the excretion of hormones, the sleep-wake cycle, the core body temperature, the tone of the autonomic nervous system and the activity rhythm are important both in health and disease processes. More attention is being paid towards the circadian variation in endogenous rhythms in relation to surgery and whether this can affect postoperative recovery, morbidity and mortality.

Studies have been done on circadian disturbances after major and minor surgery but never in relation to breast cancer surgery.

This study will investigate circadian disturbances in this specific group of patients by using Actigraphy, Polysomnography (PSG), Holter-monitoring (HRV), the primary metabolite of melatonin in urine 6-sulfatoxymelatonin (aMT6s), questionnaires and a sleep-diary.

Eligibility Criteria:
Inclusion Criteria:

* women, age 30-70, with breast cancer who are admitted for a lumpectomy at Herlev Hospital
* ASA score I-III

Exclusion Criteria:

* Known sleep apnea
* Pre-operative treatment with beta-blockers
* Diabetes Mellitus
* Known pre-operative depressive illness or dementia
* Previous or current cancer
* Known medically treated sleep-disorder (insomnia, restless legs etc)
* Shift-work
* Daily alcohol intake of more than 5 units
* Pre-operative treatment with psychopharmacological drugs, opioids or anxiolytics (including all sleeping pills)
* Predicted bad compliance
* Pregnant or breast-feeding
* Pre- or post-operative complications or events which are expected to increase morbidity or pain the first post-operative days.
* Missing written consent
* Pre-operative MMSE score less than 24
* Urine or fecal incontinence
Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A

Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A(Sacubitril∙Valsartan)


Eligibility Criteria:
Inclusion Criteria:

* Participants who are 19 years old or older.
* Participants who have voluntarily decided to participate in this clinical trial and signed ICF.

Exclusion Criteria:

* Participants with a history of secondary hypertension or suspected secondary hypertension.
* Participants with a orthostatic hypotension.
* Participants who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period.
* Participants with type 1 diabetes or poorly controlled diabetes.
* Participants who treated other clinical trial drugs within 4 weeks of screening visit.
* Participants with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
* Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last clinical trial drug
* Participants who are unable to participate in this clinical trial at the discretion of the investigator.
Vaccination Priming and Vaccine Boosting Trial of Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines (GVAX® Vaccine for Prostate Cancer)

The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with GVAX® Vaccine for Prostate Cancer. Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of GVAX® Vaccine for Prostate Cancer on serum PSA levels, will be evaluated and antitumor responses will be quantitated.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of adenocarcinoma prostate cancer that has recurred after surgery by PSA
* No evidence of measurable metastatic disease
* An ECOG performance status of 0 or 1

Exclusion Criteria:

* Transitional cell, small cell or squamous cell prostate carcinomas
* Any previous radiation therapy, prior anti-androgens or prior investigational therapy
* Previous hormonal therapy of any type for prostate cancer
* Previous biological therapy for cancer
Social and Emotional Brain Function in Cannabis Users

The aim of this functional magnetic resonance imaging (fMRI) study is to find out whether and how social and emotional brain function are altered in dependent cannabis users relative to healthy non-using control subjects after a 28 supervised abstinence period. Previous research in cannabis users has predominantly focused on cognitive functions. Moreover, studies have implicated that observed deficits in cannabis users may regenerate after a prolonged abstinence period. Findings might provide important information with respect to relapse vulnerability.


Eligibility Criteria:
Inclusion Criteria:

* Cannabis dependence according to DSM 4 criteria
* 28 days of supervised abstinence

Exclusion Criteria:

* other DSM 4 diagnosis
* neurological disorders
The Effect of Coffee After Resection of Small Bowel

Post-operative ileus ("post-op ileus") is a condition which can occur after surgery. This means that the bowels stop working correctly and food and liquids will not pass through in the normal manner. Post-op ileus can be uncomfortable and require a longer hospital stay until the bowels begin to function correctly again. Currently there are no effective methods for preventing post-op ileus. Some studies suggest there is a benefit from drinking coffee following colon or gynecological cancer surgeries with very little risk. However, the effects of coffee following small bowel surgery have not been studied. This randomized, controlled trial will compare the outcomes of patients who receive coffee during their hospital stay after small bowel surgery to similar patients who receive warm water. About 60 patients will be in each group. The main outcomes are time until the nasogastric tube is removed and length of hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing small bowel resection. Can be elective, urgent or emergent.

Exclusion Criteria:

* Patient with atrial fibrillation who is considered a non-coffee drinker (drinks coffee less than 3 days per week over the last 4 weeks)
* Patients undergoing colon resection without removal of any portion of small bowel.
FKBP5 Methylation and Childhood Emotional Abuse in Complex Posttraumatic Stress Disorder: Investigating the Relationship and Its Predictive Role in Therapy Outcome

The aim of this study is to investigate the role FKBP5 DNA methylation levels in patients suffering from complex posttraumatic stress disorder, who participated in a 12-weeks disorder-specific DBT-PTSD inpatient treatment. DNA methylation levels were measured before and after completing DBT-PTSD.

Epigenetic modifications in the FKBP5 gene, which is involved in regulating the stress response, have been found to be associated with trauma-related mental disorders like posttraumatic stress disorder (PTSD). Previous research has suggested that FKBP5 may also be a predictor of therapy outcomes. However, there is limited evidence regarding its relationship with complex PTSD (cPTSD). This pilot study aimed to investigate the association between cPTSD and FKBP5 DNA methylation, as well as its predictive role in therapy outcomes among patients undergoing Dialectical Behavior Therapy for PTSD (DBT-PTSD), a 12-week trauma-focused inpatient treatment program.

29 patients with cPTSD who participated in the DBT-PTSD program were enrolled. FKBP5 DNA methylation levels were measured at two CpG sites before treatment (n=25) and after completing DBT-PTSD (n=15). To assess the predictive value of FKBP5 DNA methylation, we categorized the sample into responders and non-responders based on therapy outcome.

Eligibility Criteria:
Inclusion Criteria:

complex posttraumatic stress disorder with or wothout comorbid borderline personality disorder Age between 18 and 65 Years Participiation in 12 weeks DBT-PTSD inpatient treatment

Exclusion Criteria:

Acute suicidality
Vilazodone for Menopausal Hot Flashes

This is a pilot study to determine proof in principle that vilazodone, a selective serotonin reuptake inhibitor and 5HT1a agonist, reduces the frequency and severity of menopausal hot flashes relative to placebo. A secondary aim is to evaluate improvement in menopause-related quality of life.

This is a proposal to conduct a small clinical trial for proof in principle that vilazodone reduces the frequency and severity of menopausal hot flashes. An additional exploratory aim is to identify improvement in menopause-related quality of life. Healthy, perimenopausal women ages 45-60 with an average of 4 or more moderate or severe hot flashes/night sweats per day for 3 screening weeks will be randomized to 8 weeks of treatment in a 2:1 ratio of vilazodone or matching placebo pills. Flexible dosing of vilazodone will start at 10 mg once/day for 7 days, increase to 20 mg/day for 1 more week and increase to 40 mg once/day at week 3 if unimproved. The primary outcome assessments are the frequency and severity of hot flashes at week 4 and week 8 as assessed by prospective daily diaries (using 7-day mean scores from the daily diaries). The secondary outcome is clinical improvement, defined as hot flash frequency \>=50% decrease from baseline. Treatment-emergent adverse events will be monitored and patient ratings of tolerability will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 45-60 years
* Amenorrhea for 60 days or more or postmenopausal or bi-lateral oophorectomy.
* 4 or more moderate or severe hot flashes or night sweats per 24 hour period (28/week) as recorded on daily diaries in 3 screening weeks.
* Hot flashes/night sweats rated as moderate to severe and/or bothersome (moderately to a lot) on 4 or more days/nights in each screen week.
* In general good health.
* Signed informed consent.

Exclusion Criteria:

* Psychotropic medications currently or within the last 30 days.
* Current use of hormonal medications such as hormone therapy or hormonal contraception or any treatment for hot flashes (Prescription, over-the-counter or herbal).
* Drug or alcohol abuse in the past year.
* Lifetime diagnosis of psychosis or bipolar disorder.
* Suicide attempt in the past 3 years or any current suicidal ideation.
* Current major depression.
* Not using a medically approved, non-hormonal method of birth control if sexually active and not postmenopausal (12 or more months since last menstrual period or bi-lateral oophorectomy).
* Pregnancy, intending pregnancy or breast feeding.
* Any severe of unstable medical illness, e.g., breast or ovarian cancer, seizure disorders, etc.
* Current participation in another intervention study.
* Inability or unwillingness to complete study procedures.
Automated Telephone Nutrition Support

The Automated Telephone Nutrition Support (ATNS) study investigates the effect of automated telephone nutrition support on diet and glycemic control among Spanish-speaking diabetics in Oakland.

The Automated Telephone Nutrition Support (ATNS) study is a joint effort between the University of California at San Francisco, La Clinica de la Raza, and patients living with diabetes in Fruitvale (Oakland). Our goal is to see if motivated people with diabetes are able to get their blood sugar under better control by choosing a healthier diet. Since it's hard to eat a healthy diet, one of the ways we are trying to help is by calling people, having them record what they've eaten, and reminding them of the right foods to eat. The innovative part is using an automated telephone system to call them to have them record their dietary choices and giving them feedback immediately regarding what to modify as appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18.
* Diabetic with A1c \>8.5 for at least 1 year based on clinic records.
* Spanish-speaking (self-defined)

Exclusion Criteria:

* No telephone at home
* Planning to be out of town for longer than 2 weeks in the coming 12 weeks and thus unable to take part in follow up
* Pregnancy
* Insulin-dependent Diabetes
* Any evidence of end organ damage including chronic kidney disease requiring dialysis, congestive heart failure, or cirrhosis.
Multicenter Trial For Patients With Acute Crohn's Disease

The purpose of this study is to see if etiprednol dicloacetate is safe and effective for the treatment of acute Crohn's disease.


Eligibility Criteria:
* Must have active confirmed Crohn's disease with CDAI \> 220 and \< 400.
* Otherwise healthy.