cyrilzakka/clinical-trials huggingface dataset:
Lay Health Worker Engage, Educate, and Encourage Patients to Share

The purpose of the LEAPS program is to understand how a trained lay health worker who engages with newly diagnosed patients after a diagnosis of an advanced stage of cancer can help to engage patients in advance care planning, improve patient satisfaction with their decision-making, activation, quality of life, and healthcare resource utilization.

Unite Here Health proposes to implement and evaluate several critical elements to be in alignment with the mission of the organization to provide high value care to their members. The Lay Health Worker Engages, Educates, and Encourages Patients to Share intervention is an innovative program that will strengthen provider-patient relationship and facilitate whole person care about matters important to Unite Here Health members who are diagnosed with cancer and important to support network and family. The project is intended to help establish Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for persons with cancer that is intended to improve clinical outcomes and experience of care for individuals. The intervention provides patients with lay health coaches who assist patients and their families in discussing goals of care and engage in shared-decision making. The goal of the project is to demonstrate that there is improved documentation of goals of care, patient experiences, patient activation and quality of life outcomes, and that the program helps to reduce utilization of health care resources at the end of life.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed patients with a cancer diagnosis.
2. Patients with any relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
3. The patients must be 18 years or older.
4. Patients must have the capacity to verbally consent.

Exclusion Criteria:

1. Inability to consent to the study due to lack of capacity as documented by the referring physician.
2. Patients without a newly diagnosed malignancy or patients without relapse of disease.
3. Patients not eligible for Fund benefits.

Patients without a newly diagnosed malignancy or patients without relapse of disease.
Treatment of Insomnia and Glucose Metabolism

Available data suggest that obtaining adequate sleep is associated with a better ability of the body to use carbohydrates as a source of energy and a lower risk of developing diabetes. The sleeping pill, Eszopiclone (Lunesta), has been approved by the Food and Drug Administration for the treatment of people who complain of trouble falling or staying asleep. This study will examine the hypothesis that the use of Eszopiclone (Lunesta) to improve the sleep of people with insomnia may also improve the use of sugar in their body.

Study participants will complete a set of oral and intravenous glucose (sugar) tolerance tests, which will be performed on two separate occasions in random order: once after a week of treatment with Eszopiclone (Lunesta) and once again after a week of receiving placebo.

Eligibility Criteria:
Inclusion Criteria:

* age between 35 and 64
* must have long-standing trouble falling or staying asleep
* BMI between 22 and 34 kg/m2

Exclusion Criteria:

* sleep apnea or other sleep disorder other than insomnia
* diagnosis of diabetes requiring treatment with pills or insulin
* smoking
* night or shift work
* presence of a medical condition that can disrupt sleep
* women only: irregular menstrual periods or pregnancy
* use of medications/compounds that can disrupt sleep
French Observational Survey to Assess Hypoglycaemia in Insulin-treated Diabetic Patients

This non-interventional study is conducted in Europe. The study is both retrospective and prospective.

The purpose of the study is to assess the frequency of hypoglycaemia (low blood glucose) in insulin-treated patients with type 1 and type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 1 or Type 2 Diabetes Mellitus
* Patients treated by insulin for at least 12 months
* Patients able to perform capillary self-monitoring plasma glucose (SMPG) measurements
* Patients able to complete the questionnaires
* Patients who have accepted to participate to the survey (signature of an information notice)

Exclusion Criteria:

* Patients with Type 2 Diabetes Mellitus not treated with insulin
* Females who are currently pregnant or lactating or who were pregnant during the previous year
Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopy

Goal of our study is to investigate whether the implication of nasal positive airway pressure (nPAP) system on patients with high periprocedural risk could significantly lower the incidence of severe hypoxia and hypercarbia. Furthermore, we have set up goals to assess key components and factors, which lead to development of hypercarbia during endoscopy.

Sedation of high-risk patients resemble a relevant issue in interventional endoscopy.

This especially because standard oximetric monitoring displays only hypoxia and not the preceding hypercapnia. Therefore, the question arises whether the implication of a nasal positive airway pressure (nPAP) system can decrease the rate of sedation associated events.

The Null Hypothesis: The incidence of hypoxia in interventional group, using nasal positive airway pressure system, in comparison to control group with conventional oxygen supplementation canula is not significant.

Alternative Hypothesis: The incidence of hypoxia in interventional group, using nasal positive airway pressure system is significantly lower, than in a control group with conventional oxygen supplementation canula

Eligibility Criteria:
Inclusion Criteria:

* ASA III (poorly controlled Diabetes Melitus (DM) or arterial hypertension (HTN), Chronic obstructive Pulmonary Disease (COPD), morbid obesity (BMI≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, End Stage Renal Disease (ESRD), Advanced Liver Disease ( ACLD) ; history (\>3 months) of Myocardial Infarction, coronary artery disease (CAD) , transient ischemic attack (TIA), or CAD/stents)
* ASA IV (recent (\<3 months MI, CVA, TIA, or CAD/stents, ongoing cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, sepsis, ARD or ESRD not undergoing regularly scheduled dialysis
* Active Malignancy (ECOG Performance \>2)

Exclusion Criteria:

* Patients with tracheotomy
* Pregnancy
* Intubation assisted endoscopy
* Procedure without sedation
Developing a Screening Tool for Primary Immunodeficiency Disease (PID) in Pakistan

Case-control diagnostic accuracy study with 130 potential pediatric PID+ (primary immunodeficiency) patients, and 100 age-matched, healthy controls (PID-). The potential PID+ participants will be recruited prospectively through 9 hospitals in Sindh and Punjab states or contacted via the PID surveillance registry developed by AKU Hospital's Polio Excretion in PID study to identify children with primary antibody deficiency (PAD+: a type of PID+); healthy, age-matched PID-participants will be recruited by snowball sampling. At the point of care, health care workers (HCWs) will collect capillary blood samples (0.1mL) to run the PID rapid screening test and reader on potential PID+ participants (identified by exhibiting \>2 of the Jeffrey Modell warning signs) and healthy, age-matched controls. All pediatric study participants will be sent to the hospital lab to have a confirmatory immunology panel (see 4.4.1 Diagnosing PID for the battery of tests) run on a serum/plasma sample to confirm their PID diagnosis (PID+/PAD-, PID+/PAD+, PID-); a 1.5uL aliquot of serum/plasma will simultaneously be used to run a PID rapid screening test by a laboratory technician (LT). HCWs and LTs will be blinded to true PID status. Blood and serum PID rapid screening test results will be compared to the confirmatory immunology panel to determine diagnostic accuracy. All clinical management of study participants will follow the standard of care for PID in Pakistan and will be based upon the immunology panel result. The HCWs and LTs administering the tests will be trained prior to the diagnostic accuracy test (see Objectives below) and will provide feedback on the tool post-training and post-use to assess usability, acceptability, and feasibility of integrating the test and digital reader into tertiary hospitals for the purpose of improved national PID surveillance, improved PID patient care, and polio eradication in Pakistan.


Eligibility Criteria:
Inclusion Criteria:

* Aged 3 months to 15 years

  * Presents for care at 1 of 9tertiary hospitals participating in the study
  * Potential PID+ (Case): Child is identified by HCW to have \>2 Jeffrey Model warning signs of PID. \[Note: Upon immunology panel testing, this group will be separated into three categories: PID-, PID+, and PID+/PAD+ meaning they have 1 of 5 relevant primary antibody deficiencies (PAD+)\].
  * PID-(Control): Child is identified (by snowball sampling) as being in good health, and having the same age (within 12 months) as another child who produced a PID+ result.
  * Caregiver consents to participate in the study and provides informed consent. If their children are 10 years of age or older, that child must also give assent.

Exclusion Criteria:

* Aged less than 3 months or greater than 15 years of age

  * Caregiver does not consent to participate, or child \>10years does not give assent to participate.
  * Having received IVIG in the past 90 days
A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)

This study will evaluate whether the addition of Sitagliptin treatment provides a greater decrease in A1C levels compared to placebo in participants with inadequate glycemic control on sulfonylurea and metformin combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Hemoglobin A1C of ≥7.5% and ≤10.5%
* Currently taking a stable dose of metformin (at least 1500 mg/day) and either glimepiride (at least 2 mg/day) or gliclazide (at least 50% of maximum registered dose) for at least 10 weeks prior to study start
* Male, or a female who is highly unlikely to conceive

Exclusion Criteria:

* Type 1 diabetes mellitus or ketoacidosis
* Taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin) or a glucagon-like peptide-1 (GLP-1) mimetic (such as exenatide or liraglutide) or required insulin therapy within 12 weeks prior to study start
* On a weight loss program not in the maintenance phase or on a weight loss medication
* History of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
* HIV positive
* Pregnant
Tomosynthesis Use in Detecting Subtle Occult Hip Fractures

The purpose of this project is to determine if using tomosynthesis, in conjunction with x-ray, is better at detecting hip fractures than using x-ray alone. The goal of this study will be to include the use of tomosynthesis with x-ray as usual practice when a patient comes to the emergency room with symptoms of a hip fracture.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged \> 18 years who/se:
* Present at the ER with a possible hip fracture and
* Have a negative x-ray for a hip fracture
* Physician has a high clinical suspicion of a hip fracture
* Provide provision of informed consent

Exclusion Criteria:

* Hip prosthesis on the same side of the suspected hip fracture
* Other serious medical illness that is likely to interfere with study participation
* Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the trial procedures
* Pregnant or suspected pregnancy
Epidemiology of Post-influenza Bacterial Pneumonia Due to a Panton-Valentine Leukocidin Positive Staphylococcus Aureus

Secondary bacterial influenza pneumonia caused by Panton-Valentine Leukocidin Positive Staphylococcus aureus is a rare complication but with poor prognosis. This pathology seems to affect young patients (20-40 years) without any medical history. Since the influenza pandemic of 2009, this complication is more and more mentioned, sought and diagnosed. However, the literature is poor, consisting of case reports, experimental studies on murine models, and low-power studies.

The main objective is to evaluate the mortality in intensive care units of patients post-influenza bacterial pneumonia due to a Panton-Valentine Leukocidin positive Staphylococcus aureus


Eligibility Criteria:
Inclusion Criteria:

* Patient treated for post-influenza bacterial pneumonia due to a Panton-Valentine Leukocidin positive Staphylococcus aureus in intensive care unit

Exclusion Criteria:

* Minor patient
* Patient under protective measurement
* Absence of bacteriological and / or virological documentation
The Study of Metabolic Syndrome in Hemodialysis Patients

Metabolic syndrome (MS), comprised of central obesity, glucose intolerance, hyperinsulinemia, low HDL-cholesterol (HDL-C), high triglyceride (TG) and hypertension, results in markedly increased risk for cardiovascular disease in the general population. The National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) report recommended the use of five variables for the diagnosis of the MS including waist circumference (WC), serum TG concentration, serum HDL-C concentration, blood pressure and fasting glucose concentration. A waist circumference of 80 cm in women and 90 cm in men would better identify those with the MS in Asian populations. However, the studies of modified asian criteria of metabolic syndrome in hemodialysis (HD) patients are scarce.

We will perform prevalence investigation, cross-sectional study, and prospective investigation for metabolic syndrome in our HD patients (around 360 at present). We will enroll all the patients who receive maintenance HD more than three months in our HD center. The patients who are hospitalizing, suffered from active malignancy, active infections, recent cardiovascular events and surgery will be excluded in the beginning of study. Biochemistry and anthropometric parameters including HDL-C, TG, insulin resistance index, high sensitivity C-reactive protein and WC will be collected and analyzed. We will also prospectively establish the mortality and hospitalization indices of these patients, to study the prognosis of HD patient with or without metabolic syndrome.

This study will be helpful to understand whether the application of a modified criteria of metabolic syndrome in HD patients is capable to predict cardiovascular events, hospitalization and mortality rates.


Eligibility Criteria:
Inclusion Criteria:

* We will enroll all the patients who receive maintenance HD more than three months in our HD center.

Exclusion Criteria:

* The patients who are hospitalizing, suffered from active malignancy, active infections, recent cardiovascular events and surgery will be excluded in the beginning of study.
EnMotion, Embryo's Natural Motion

The purpose of the study is to determine if a dynamic embryo microenvironment impacts embryo development and reproductive potential in comparison to static culture.

The proposed research design is a prospective randomized control trial. Patients with normal ovarian reserve, who would be expected to have reasonable outcomes after in vitro fertilization, will serve as the subjects. Embryos from the same patient will be randomized to either static or dynamic culture. They will then be cultured to the blastocyst stage of embryo development and biopsied for preimplantation genetic screening. The best chromosomally normal embryo from each culture group will be selected and transferred to complete a double embryo transfer in a subsequent frozen embryo transfer cycle the following month.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women seeking in vitro fertilization treatment with aneuploidy screening
* Patient is eligible for a two-embryo transfer in compliance with ASRM guidelines
* Patient able to undergo a frozen embryo transfer cycle the month following the vaginal oocyte retrieval procedure
* Maximum day 3 Follicle-stimulating hormone level (≤12 IU/L)
* Anti-mullerian hormone level ≥ 1.2g/mL, tested within previous year
* ≤1 prior failed IVF cycle
* Male partner with \>100,000 total motile spermatozoa per ejaculate (donor sperm acceptable)
* Body Mass Index ≤ 32
* Antral Follicle Count ≥ 8

Exclusion Criteria:

* Diagnosis of endometrial insufficiency defined as a prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
* Use of oocyte donation
* Use of gestational carrier
* Medical contraindication to double embryo transfer
* Use of testicular aspiration or biopsy procedures to obtain sperm
* Presence of a hydrosalpinx that communicates with the endometrial cavity
* Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation
* Single gene disorder requiring more detailed embryo genetic analysis
A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients

To determine the safety and efficacy of oral valacyclovir hydrochloride ( 256U87 ) compared to acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients with CD4 counts = or \> 100 cells/mm3.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection with CD4 counts = or \> 100 cells/mm3.
* Documented culture of anogenital herpes simplex virus (HSV) within the last 5 years.
* History of recurrent anogenital HSV infection, with a recurrence (with or without culture) within 1 year prior to study.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Malabsorption or vomiting that would potentially limit the retention and absorption of oral therapy.

Concurrent Medication:

Excluded:

* Systemic antiherpes medication.
* Interferon.

Patients with the following prior conditions are excluded:

History of hypersensitivity to acyclovir.
CONNECTing Head and Neck Caregivers to Supportive Care Resources

The purpose of this research is to determine feasibility and acceptability of randomized pilot trial to evaluate a technology-based intervention (CONNECT) to empower and educate caregivers about the benefits of supportive care resources, identify their unmet needs, and connect them with resources.

The registration is for Objective two and three that refers to the clinical trial. The investigators will determine their ability to recruit caregivers of patients with head and neck cancer being treated at Wake Forest Baptist Comprehensive Cancer Center to a study that uses a technology-based intervention, CONNECT, which may increase head and neck cancer caregivers' knowledge about the benefits of supportive care resources, identify their unmet needs, and connect them with supportive care resources. In this study the investigators also want to look at their ability to recruit a control group of caregivers, that is, caregivers of patients with head and neck cancer being treated at Wake Forest Baptist Comprehensive Cancer Center that will receive a list of supportive care resources. Control groups are used in research to see if the intervention being studied really does have an effect. In addition, the investigators will determine whether or not the intervention has led to improvements in caregivers' use of supportive care resources, quality of care, and overall quality of life.

Eligibility Criteria:
Inclusion Criteria:

Eligible caregivers include those who are:

* Caregivers must be providing some capacity of informal (unpaid) care for a patient meeting patient eligibility criteria. If a patient unexpectedly becomes deceased during the study period, caregivers will be allowed to continue participation in the assigned study arm and complete study assessments if they wish to.
* Greater than or equal to 18 years of age.
* Ability to access study materials by internet or complete study activities in person as institutional and government policies allow.

Eligible patients include those who:

* Have new or recurrent American Joint Committee on Cancer (AJCC) stage I-IV head and neck cancer.
* Are receiving cancer treatment or awaiting planned treatment initiation, excluding those receiving neoadjuvant surgery or surgery only.
* Patients must be ambulatory and up more than 50% of waking hours, as measured by an ECOG Performance Status rating of level 0, 1, or 2.
* Greater than or equal to 18 years of age.
* Ability to access study materials by internet or complete study activities in person as institutional and government policies allow.
* Patients must be receiving some capacity of informal care from a caregiver meeting the above criteria. If the caregiver unexpectedly becomes deceased during the study period, the patient will be un-enrolled from this study as we are evaluating a caregiver-only delivered intervention.

Exclusion Criteria:

Caregivers will be excluded if:

• Cannot read/communicate in English

Patients will be excluded if they:

• Cannot read/communicate in English

Eligibility to participate in the study is conditional on participation of both the caregiver and patient.
Farnesyl Protein Transferase Inhibitor (FPTI) in Combination With Docetaxel in Advanced Solid Tumors (Study P01964)(COMPLETED)

The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase Inhibitor (SCH 66336) when given in combination with intravenous docetaxel in cancer patients with advanced solid tumors.


Eligibility Criteria:
Inclusion:

* Male or Female
* Measurable or evaluable disease
* No more than 2 prior chemotherapy regimens.
* Age greater than or equal to 18.
* Karnofsky Performance Status greater than or equal to 70%.
* Meets protocol requirements for specified laboratory values.
* No manifestations of a malabsorption syndrome.
* Written informed consent and cooperation of patient
* Appropriate use of effective contraception if of child-bearing potential.

Exclusion:

* Acute or chronic leukemia or multiple myeloma.
* Evidence of 2 or more active malignancies, expect for in situ or adequately treated basal or squamous cell skin cancer.