cyrilzakka/clinical-trials huggingface dataset:
An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets

The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety of this treatment will also be studied


Eligibility Criteria:
Inclusion Criteria:

* Males \& females, 18-77 years old inclusive, with type 2 diabetes and with inadequate glycemic control
* Drug naive or treated with anti-diabetic medication for \< 24 weeks since original diagnosis
* C-peptide ≥ 1.0 ng/mL
* Body Mass Index ≤ 45.0 kg/m
* Serum creatinine \< 1.50 mg/dL for men or \< 1.40 mg/dL for women

Exclusion Criteria:

* AST and/or ALT \>3.0 times the upper limit of normal (ULN)
* Serum total bilirubin \> 2.0 mg/dL
* Creatine kinase \> 3X the upper limit of normal (ULN)
* Symptoms of severely uncontrolled diabetes
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric or rheumatic diseases
Change of Depth in a RAE Tube: Tube Fixation at the Midline or Angle and in a Neutral or Neck Extended Position

The investigators compared the depth of the RAE tube \[Preformed oral tracheal tubes were first described by Ring, Adair and Elwyn (therefore called RAE tubes)\] when fixed at the midline and at the angle of the mouth, and after fixing the tube at the angle.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* Patients with anatomical defects of the face, neck, or upper airway
Written Exposure in Substance Treatment

The purpose of this pilot randomized clinical trial is to test the feasibility and efficacy of written exposure therapy (WET) for posttraumatic stress disorder (PTSD) within the context of residential substance use disorder (SUD) treatment. All participants meet criteria for PTSD and are in a short term residential SUD treatment program (target residential treatment duration = 28 days) regardless of the research. The main questions the study aims to answer are: 1) Is the delivery of WET feasible in short term residential SUD treatment for individuals with severe SUD; 2) Do participants in the TAU+WET condition have greater reductions in PTSD symptoms pre/post treatment compared to participants in TAU alone?


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Fluent in English
* Cognitively able to provide consent to the research
* Enrolled in inpatient treatment at the clinical site where the research takes place
* Meet criteria for probable PTSD based on PCL-5 score
* Be early enough in their residential stay to allow time to complete the WET protocol
* Have a clear memory of the traumatic event so they are able to write about itin detail

Exclusion Criteria:

* Reports significant suicidal or homicidal ideation with intent, untreated psychosis, or have other health limitations that may interfere with their ability to participate in the research
Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease

Modifying health behaviors like physical activity level, diet, stress, and mental activity level can lower risk for Alzheimer's disease, but many middle-aged and older adults find it difficult to sustain health behavior changes over the long term. This project will develop a new intervention that educates people about Alzheimer's disease risk factors and helps them understand how their personal health beliefs may prevent them from making long-lasting lifestyle changes. The goal is to help people sustain health behavior changes to prevent or delay the onset of Alzheimer's disease and related dementias.


Eligibility Criteria:
Inclusion Criteria:

* age 45-69 years
* normal cognition (Minnesota Cognitive Acuity Scale \> 52)
* English language fluency
* at least two of the following: i) BMI \> 24.9; ii) systolic blood pressure \> 125 mmHg; iii) LDL cholesterol \> 115 mg/dL; iv) HbA1C \> 6.0%; v) at least one APOE ε4 allele; vi) first-degree relative with AD.

Exclusion Criteria:

* history of serious mental illness (i.e., schizophrenia, bipolar disorder)
* history of neurologic or neurodevelopmental disorder
* current alcohol or drug use disorder based on self-report
* current enrollment in an AD prevention clinical trial.
Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds

To evaluate and compare the effect of the prophylactic use of two different exposure times of mitomycin C (MMC) 0.02% to inhibit haze formation after photorefractive keratectomy (PRK) for high myopia (\> -7.0 D).

Methods: Forty six eyes of twenty three patients, 8 men and 15 women, with high myopia were included in this prospective study. Mean age at the time of PRK plus MMC was 31.7 years. Before PRK, the mean spherical equivalent was -8.50 D (range, -7.25 to -10.50 D). In each patient, one eye was randomly assigned to PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds (Group 1) and the fellow eye, for 30 seconds (Group 2).The inclusion criteria were high myopia, no central corneal opacity and inadequate corneal thickness to allow a safe Laser in situ keratomileusis procedure. Refraction, uncorrected visual acuity, best spectacle-corrected visual acuity (BSCVA), and slit-lamp evidence of corneal opacity (haze) were evaluated over 12 months


Eligibility Criteria:
Inclusion Criteria:

* Myopia or compound myopic astigmatism
* Stable refractive error
* No associated eye disease

Exclusion Criteria:

* Diabetes,
* Autoimmune diseases
* Topographic abnormalities
Preoperative Nutritional Status Associated With Delayed Discharge in Elderly Patients Undergoing Gastrectomy

Gastric cancer (GC) remains the 5th most common cancer worldwide and had the second- highest mortality rate in China. The population of elder patients with GC has been increasing because of the high prevalence of H. pylori infection and increasing life expectancy. Elderly GC patients face several challenges during treatment, such as comorbidities, organ dysfunction, immunosuppression, and delayed recovery. Advanced age is associated with a higher rate of postoperative complications shortly after surgical treatment, and lower 5-year overall survival as long-term outcome.

In China, the prevalence of malnutrition in hospitalized patients is around 12.6% to 46.19%. Malnutrition is one of the great risk factors of adverse clinical outcomes in elderly patients with GC. The nutritional status at the time of diagnosis was independently associated with postoperative complications, overall survival, and disease-free survival. The condition can be caused by mechanical obstruction of the digestive tract or anorexia-cachexia syndrome, leading to insufficient protein or energy intake and absorption disorder. Nutrition screening, assessment, and intervention are important steps in nutritional management.

Previous studies mostly focused on hospitalized internal medical patients. Only a few studies focused on surgical patients regardless of age. Therefore, in this retrospective study, we are going to investigate the nutritional status and perioperative nutritional support of geriatric surgical patients with GC, and provide a basis for implementing an effective nutritional intervention.


Eligibility Criteria:
Inclusion Criteria:

Patients aged 60-90 years old; Patients with gastric cancer; Patients who underwent radical gastrectomy. -

Exclusion Criteria:

Patients with other malignancies; Patients with previous gastrointestinal surgery or emergency surgery; Patients with incomplete medical record.

-
Addressing Disparities in Food Access Among Young Children in Louisiana: A Farm to ECE Approach

The goal of this pilot project is to increase access to healthy food, improve diets, and reduce food insecurity and, in turn, reduce health disparities among low-income, minority children under the age of five attending early childcare centers. Specific aims are to: 1) examine the feasibility of a six-month Farm to ECE intervention and 2) collect preliminary data to evaluate the efficacy of the program to 2.1) improve the ECE nutrition environment from baseline to follow-up; 2.2) increase access to local fruits and vegetables among children at ECEs from baseline to follow-up; and 2.3) increase parent knowledge and use of community food resources. The investigators will use this preliminary data to develop a larger scale project to test intervention efficacy.

The pilot study will take place at four centers within a network of Catholic Charities Early Head Start and Head Start Centers in New Orleans, Louisiana. Two centers will serve as intervention sites and two as comparison sites. Over 90% of the network centers' students identify as Black, and all qualify for federally funded free meals and snacks. The intervention will include: (1) assisting ECEs with conducting self-assessments; (2) connecting ECEs with local farmers and food producers; (3) providing technical assistance for menu changes, procuring healthy food, identifying and implementing best feeding practices and policies for the environment; (4) delivering nutrition education; and (5) connecting parents/guardians with local food resources and affordable fresh food to be consumed at home. The intervention will be implemented for 6 months.

Aim 1 uses a cross-sectional mixed methods design, collecting both quantitative and qualitative data in intervention centers. Aim 2 uses a pre-post design with a comparison group, collecting quantitative survey data at the center and parent level. At baseline and six-month follow-up, the investigators will conduct short surveys with staff and parents/caregivers of children attending ECEs.

Eligibility Criteria:
Inclusion Criteria (Key informant interviews and center assessments):

* Director or staff of participating center
* 18 years of age minimum

Exclusion Criteria (Key informant interviews and center assessments):

• Staff not involved with educational programming

Inclusion Criteria (Parent/guardian surveys):

* Parent or guardian of current student at participating center
* 18 years of age minimum

Exclusion Criteria (Parent/guardian surveys):

• None
Patient-centered, Optimal Integration of Survivorship and Palliative Care

The goal of this study is to develop and test the feasibility of a supportive care model (POISE) for patients with metastatic Non-small Cell Lung Cancer (NSCLC). The main questions are

* is POISE feasible to deliver and acceptable to patients
* what is the effect of POISE on the distress patients feel related to their uncertain future, their confidence in their ability to manage cancer, and their understanding about what to expect Participants in the randomized controlled trial will receive either the new supportive care model, POISE, which consists of four visits with a trained palliative care clinician, or care as usual, and will be asked to complete three surveys.

This research study involves an intervention consisting of four sessions with palliative care specialists who have been additionally trained to evaluate and address the specific psychosocial issues and health-promoting behaviors of patients with NSCLC.

The research study procedures include:

* Four 60-minute visits with a trained palliative care clinician
* Questionnaires and an exit interview
* Chart Review

It is expected that about 70 participants currently receiving targeted therapy at Massachusetts General Hospital for lung cancer will take part in this research study: 10 patients in an open pilot study, followed by 60 patients in a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* MGH Cancer Center patient
* Within 6 months of diagnosis of metastatic NSCLC with oncogenic driver mutation (EGFR, ALK, ROS1, RET)
* Receiving targeted therapy
* Ability to respond in English or Spanish

Exclusion Criteria:

* Cognitive impairment or serious mental illness that limits ability to provide informed consent
* Need for urgent palliative care or hospice referral
* Pregnant women
* Prisoners
Assessment of Cognitive Functions in Bipolar Patients

Assessment of cognitive function in manic bipolar patient

Assessment of severity of mania and depression in bipolar patients then evaluate their cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-55 years
* Of both sex
* Diagnosed as bipolar by DSM-5(patient)

Exclusion Criteria:

* Current medical and psychiatric comorbidities which may affect cognitive status.
* Substance abuse or dependence (except nicotine and caffeine)in last month.
* Somatic treatment with drugs known to affect cognitive status (cortisol, antihistamines, etc.)
Evaluating Yoga for Chronic Low Back Pain

This study will compare the effectiveness of yoga classes, exercise classes, and a self-care book in the management of pain and function for people with low back pain.

Back problems are among the most prevalent conditions affecting adults and are a leading reason for using complementary or alternative medical (CAM) therapies. Despite the common use of CAM therapies for back pain, little is known about how they compare with conventional treatments. This study will lay the groundwork for a full-scale trial that compares yoga with conventional exercise and usual care for chronic low back pain.

This study will randomize 30 people with chronic low back pain to each of the following groups: yoga, a conventional therapeutic exercise program, and usual care. There will be 12 weeks of weekly treatment and follow-up assessments via phone at 6, 12, and 26 weeks to measure each treatment's impact on symptoms, function, quality of life, and utilization and costs of back pain related care.

Eligibility Criteria:
Inclusion criteria:

* Group Health Cooperative enrollee
* Uncomplicated low back pain
* At least moderate pain levels

Exclusion criteria:

* Sciatica persisting 3 or more months after physician visit
* History of cancer (other than nonmelanoma skin cancer)
* Severe disk problems
* Unstable medical conditions
* Back surgery within past 3 years
* Physically unable to do the yoga or exercise classes and homework
* Unable to attend classes
* Currently doing yoga
* Taken exercise class for back pain within past year
* Currently in litigation for back pain
* Seeking other treatment for back pain
Genetic Evaluation of Men (GEM)

This is a prospective research registry and prospective genetic testing cohort study. The goal is to collect personal medical and cancer history data, family cancer data, exposure history, and biospecimens to support research focused on optimal genetic testing strategies for men with prostate cancer with the ultimate goal of informing national guidelines focused on genetic evaluation for prostate cancer.

Objectives:

1. Collect detailed family cancer histories, personal medical history, prostate cancer clinical features, and exposure history from men with prostate cancer and men without prostate cancer to support studies focused on identifying hereditary cancer syndromes and genetic/epidemiologic factors predisposing to prostate cancer susceptibility.
2. Collect behavioral measures to support research focused on assessing the needs of men undergoing cancer risk evaluation and satisfaction with the process.
3. Create and maintain a biospecimen bank with specimens from men with prostate cancer and without prostate cancer to support studies focused on genetic alterations predisposing to prostate cancer risk.
4. Perform targeted and broad-scale genetic and genomic sequencing to detect genetic alterations related to prostate cancer risk.
5. Develop mechanisms to recontact participants with updates on research genetic results to guide genetic testing for inherited prostate cancer risk.

Eligibility Criteria:
Inclusion Criteria:

1. Men with a personal history of prostate cancer
2. Unaffected males who are at higher risk for prostate cancer

Exclusion Criteria:

1. Age \< 18 years
2. Mental or cognitive impairment that interferes with ability to provide informed consent
3. Social circumstances that may impair the ability to follow through with study or provide informed consent (such as homelessness, drug/alcohol dependence, etc.)
Teduglutide for Enterocutaneous Fistula (ECF)

The purpose of this study is to determine whether Teduglutide is safe and feasible to be given for the treatment of enterocutaneous fistula (ECF). The hypothesis is that the drug will be well tolerated and will improve the volume of daily ECF output as well as improve the functional quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Enterocutaneous fistula (ECF) that could be secondary to volvulus, injury, prior trauma or surgery, or vascular ischemia

Exclusion Criteria:

* Perianal fistula
* Clinical suspicion of inflammatory bowel disease
* History of radiation enteritis or sprue (as defined by history)
* Active (\<1 year) alcohol or drug abuse
* Significant hepatic, or cardiac diseases as defined as:
* Hepatic: aspartate aminotransferase (AST) \> 2 times upper limit of normal (10-40 U/L)
* Cardiac: unstable angina or evidence of active myocardial ischemia (elevated troponin level drawn by clinical suspicion)
* Severe renal dysfunction: serum creatinine \> 2 times upper limit of normal (0.6-1.5 mg/dL)
* Received glutamine less than 4 weeks prior to screening
* Receiving growth factors (erythropoietin, granulocyte colony-stimulating factor, granulo-cyte-macrophage colony stimulating factor, and human growth hormone)
* Pregnancy or lactation (women of childbearing age will be excluded if they do not agree to either complete sexual abstinence during the study or if they refuse to use at least two forms of highly effective contraception such as oral contraception, injectable or implantable contraception, vaginal rings, or intrauterine devices (IUD))
* Active malignancy or suspicion for gastrointestinal malignancy on CT scan
* Not capable of understanding or not willing to adhere to the study visit schedule and drug administration requirements
* Family history of intestinal malignancy (gastric, small intestine, colon)
* Personal or family history of hereditary non-polyposis colorectal cancer, familial adenomatous polyposis, first degree relative with colon cancer
* Positive hemoccult (per rectum)
* Abnormal baseline electrocardiogram (ECF) suggestive of congestive heart failure or underlying cardiac disease
* Taking oral benzodiazepines, barbiturates, or phenothiazines
Evaluation of a Social-networking Intervention to Reduce Cancer-related Distress

It is hypothesized that the treatment group will show greater improvements in quality of life and mood disturbance compared to the control group and that greater levels of engagement with the intervention materials will be associated with greater improvements in mood and quality of life.

Individuals with cancer face an array of psychosocial needs, and it has been estimated that up to 35% of cancer survivors experience clinically-significant levels of distress. Psychosocial interventions may be effective for improving quality of life and reducing levels of mood disturbance in these patients. Unfortunately, barriers to accessing psychosocial intervention are common, and many are unable to access those services. Internet- based psychosocial interventions improve accessibility of care and offer additional methodological advantages, including the ability to easily collect self-report data, track exposure to the intervention, and evaluate effects of specific intervention components. The proposed study will evaluate whether a website developed specifically for providing psychological treatment and enhancing communication between cancer survivors can improve distress among cancer survivors who indicate that they have high levels of distress. If successful, the study will also provide valuable information needed to improve the treatment and to adequately conduct a larger trial comparing internet-based and face-to-face treatments.

Eligibility Criteria:
Inclusion Criteria:

1. at least 18 years of age,
2. previous cancer diagnosis other than non-melanoma skin cancer,

4) fluent in English, 5) routine access to the Internet, and 6) presence of greater than mild distress as identified by having distress greater than or equal to 4 on initial screening with the Distress Thermometer
Intensive Case Diabetes Management (ICDM) to Prevent Readmission

The purpose of this study is to assess whether intensive case management interventions by a diabetes team, led by an endocrinologist and certified diabetes educator, can prevent \<31 day readmission in previously identified high risk patients with diabetes.The procedures of the study will focus on managing the patient's diabetes and diabetes education while in the hospital, decreasing the patient's risk for hypoglycemia and hyperglycemia in the hospital, and assist in the patient's diabetes management plan for a safe discharge.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted with a diagnosis of diabetes, Patients with a previous history of Pharmacy Expert System (PES) alert, Enrollment in research must be within 24 hours of admission

Exclusion Criteria:

* Patients transferred from institutionalized care, Patients who already plan to move to institutionalized care, Patients with severe co-morbidities (e.g. terminal cancer), Patients admitted for surgery within 24 hours, Patients who are unwilling or unable to give written consent (e.g. dementia), Patients who are homeless, Patients previously admitted to the diabetes endocrine service