cyrilzakka/clinical-trials huggingface dataset:
Mitigating ACEs in Pediatric Primary Care

The project is designed to assess Adverse Childhood Experiences (ACEs) and test a parenting intervention in pediatric primary care.

The goal of the project is to affect policy and practice related to Adverse Childhood Experiences (ACEs) screening and intervention in pediatric primary care. First, the investigators will develop and test a new ACEs screening tool that is brief, has a pediatric perspective, builds on parents' strengths, and measures parenting-related ACEs that can be treated. The new ACEs screening tool will measure parenting-related ACEs (e.g. corporal punishment, threatening, humiliation) and family stressors (e.g. divorce, incarceration, mental illness). A research assistant will invite approximately 1000 parents to complete the survey in the Vanderbilt Pediatric Primary Care Clinic. Measures will include child behavior problems that the investigators hypothesize will be associated with elevated parenting scores. The second part of the project will be to recruit English and Spanish-speaking parents for a randomized controlled trial (RCT) to determine if educational interventions can help educate parents about ACEs and decrease parenting-related ACE scores two months post-intervention. In the RCT, the investigators will recruit 300 to 400 parents to participate in the study. Parents in the intervention group will receive 1) a copy of the Play Nicely Healthy Discipline Handbook, 2) information about how to view the Play Nicely multimedia program online and 3) the TN ACEs Handout. Parents in the Control Group will receive routine primary care. Follow up data will be obtained 2 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Parents of 2-10 year old children presenting for a well visit.

Exclusion Criteria:

* Parents do not speak English, Spanish, or Arabic.
Is Conditioned Pain Modulation Predictive of Clinical Improvement in Patients With Chronic Low Back Pain?

Conditioned pain modulation (CPM) a measure of the effectiveness of the descending pain pathway and therefore a measure of the body's ability to perform endogenous analgesia. In subjects with normal function of the descending pain pathway, the net-effect during CPM testing is anti-nociceptive, or inhibition of the ascending pain pathway. In those with impaired descending pain pathway function, the response to CPM testing is pro-nociceptive, indicating that the body is unable to inhibit the pain signal, or may even amplify it. There is literature that supports the presence of impaired CPM, and therefore impaired descending pain pathway function, in numerus chronic pain conditions, including low back pain. Impaired descending pain pathway function may be contributing to this chronic pain presentation. This study will give us information on whether a typical physical therapy plan of care is able to improve impaired CPM, and if CPM values are predictive of improvement in physical therapy.


Eligibility Criteria:
Inclusion Criteria:

* DEERS eligible
* English speaking
* Age 18-64 years
* ODI baseline ≥25%
* NPRS baseline ≥3/10
* Low back pain symptoms greater than 3 months
* Must be able to commit to at least six weeks of physical therapy interventions

Exclusion Criteria:

* Serious spinal pathology (acute fracture, active cancer, inflammation, inflammatory arthropathy)
* Low back pain symptoms radiating below the knee
* Pregnancy
* Diagnosed neurological disease including traumatic brain injury, multiple sclerosis, chronic regional pain syndrome, and fibromyalgia.
* History spinal surgery
* Currently under litigation related to low back pain
* Currently going through Medical Evaluation Board (MEB)
* Retiring or separating from the military within a year
Use of Phytonadione to Reduce International Normalized Ratio (INR) Variability in Patients on Long-term Warfarin Therapy

Background: Warfarin is used as an anti-coagulant in patients at risk of developing thrombosis. It has a narrow therapeutic index necessitating close monitoring of International Normalized Ratio (INR). According to a meta-analysis, patients were in therapeutic range only 63.6% of the time. This increases the risk of bleeding or thrombosis. Various retrospective and prospective studies have looked at supplementation with phytonadione in these patients to reduce the variability of INR showing an improvement in variability. Most of these studies have only been done in a small number of patients already on warfarin therapy. This study will focus on patients newly starting warfarin therapy.

Methods: This study is a prospective, randomized, controlled trial performed at James A. Haley Veterans' Hospital (JAHVA). Patients who meet criteria and sign informed consent will receive either phytonadione with warfarin or warfarin alone. Based on a power calculation for 80%, a total of 370 patients will be enrolled (185 participants in each arm). Participants will be randomized to either intervention or control. Intervention group participants will be prescribed their usual starting dose of warfarin along with 200 mcg phytonadione by mouth daily. Control group participants will be prescribed their usual starting dose of warfarin. Both groups will follow the usual standard of care. They will come in for a follow-up INR and warfarin dose titration at least once per week until therapeutic, and then as instructed up to every 6 weeks thereafter. Both groups will participate in anticoagulation clinic activities that constitute the current standard of care. Intervention will last for a total of 6 months for each participant once enrolled.

Hypothesis:Participants in the intervention group being supplemented with 200mcg of phytonadione will spend more total time with a therapeutic INR than participants in the control group.

See above.

Eligibility Criteria:
Inclusion Criteria:

* Be eighteen years of age and older
* Have a long-term indication for warfarin (will need to be on warfarin for 6 months or longer)
* Be a new patient on warfarin therapy, or a patient previously on warfarin therapy who has been taken off therapy for more than 2 weeks and needs to be titrated again
* Anticipate receiving medical care at the study site for the duration of the study
* Have transportation to and from the JAHVA
* Have read and signed the Informed Consent document after the study has been fully explained and has had all questions answered

Exclusion Criteria:

* Have liver or kidney failure
* Are on hemodialysis or peritoneal dialysis
* Are pregnant or planning to become pregnant
* Have Alzheimer's disease, cognitive impairment, or visual impairment
* Are not compliant with medications
* Are participating in another study
* Have scheduled surgery or are planning to undergo major surgery
* Cannot be reached by telephone
* Take over-the-counter vitamin K supplementation except multivitamins
Therapeutic Cocaine Vaccine: Human Laboratory Study

Clinical data demonstrate that a cocaine vaccine (TA-CD: Celtic Pharmaceutical) produces selective anti-cocaine antibodies, yet the impact of these antibodies on cocaine's direct effects is unknown. The objective of this human laboratory study was to measure the relationship between antibody titers and the effects of smoked cocaine on ratings of intoxication, craving and cardiovascular effects.

Cocaine-dependent volunteers not seeking drug treatment spend 2 nights per week for 13 weeks inpatient where the effects of cocaine (0, 25, 50 mg) are determined prior to vaccination and at weekly intervals thereafter. Vaccinations occur at weeks 1, 3, 5 and 9.

I do not desire to provide a more extensive description.

Eligibility Criteria:
Inclusion Criteria:

1. Meets DSM-IV criteria for current cocaine dependence. The volunteer may meet criteria for other substance abuse, but not dependence (other than nicotine).
2. Primary route of cocaine administration is smoking.
3. Age 21-45.
4. Females must be surgically sterilized or post- menopausal
5. Able to give informed consent, and comply with study procedures.

Exclusion Criteria:

1. Dependence on substances other than cocaine or nicotine.
2. Judged to be noncompliant with study protocol.
3. History of autoimmune disease, immune deficiency or hypersensitivity to other vaccines. An HIV test must be negative.
4. Currently uses drugs intravenously
5. Currently taking any psychotropic medication
6. Laboratory tests that are clinically unacceptable to the study physician (BP \> 140/90; BUN, creatinine, LFTs \> 1.5 ULN; hematocrit \< 34 for women, \< 36 for men)
7. Blood or blood products given in the three months prior to vaccination
8. Other vaccines, including flu vaccine, given within 30 days of screening.
9. Ongoing active infection
10. Currently taking immunosuppressives -
OPALINE : A Study Of Morbidity And Mortality At 2 Years

A descriptive, prospective (partly retrospective), multisite, observational study conducted in France in adult patients treated for a well differentiated, unresectable or metastatic, pancreatic neuroendocrine tumor with disease progression.

prospective and retrospective Analyses will be performed using SAS® software

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age;
* Patients treated with a targeted therapy (sunitinib, everolimus) or with other treatments (interferon, or metabolic radiotherapy, or chemotherapy or somatostatin analog)\* for:

  \*Patients whose treatment line (targeted therapy or other treatment) is initiated as a 1st, 2nd, 3rd or 4th line of therapy at the time of inclusion (incident patients) or patients receiving their 1st, 2nd, 3rd or 4th line of therapy provided that treatment was initiated in the site in which the patient is enrolled in the study (prevalent patients); a change of line is defined as a change in molecule or combination.
* A histologically confirmed unresectable or metastatic pancreatic neuroendocrine tumor;
* Well-differentiated;
* Progressive prior to initiation of treatment in the investigator's judgment (clinical or radiological progression);
* Patients who have been informed of the conditions of the study and who have signed the informed consent.

Exclusion Criteria:

* Patients with a diagnosis of poorly differentiated neuroendocrine carcinoma or an adenoneuroendocrine carcinoma.
* Patients receiving targeted therapy (everolimus or sunitinib) already received in a previous line of treatment (rechallenged patient).
* Patients refusing to give consent.
* Patients receiving a fifth line or subsequent line of systemic treatment.
* Patients participating in a clinical trial in a treatment arm not validated by the MA and the TNCD according to the version dated December 2013.
* Patients randomized to the placebo arm of a placebo-controlled trial or to a double-blind trial.
Michigan Contraceptive Access, Research, and Evaluation Study Children: Phase 1

This project builds on the Michigan Contraceptive Access Research and Evaluation Study (M-CARES) to evaluate the long-term effects of mothers' access to free contraceptives and reductions in unintended pregnancies on their children's well-being.

M-CARES uses a randomized control trial design to assess the effects of providing free contraception to mothers on their children born before the intervention. The population subject to intervention is fecund women age 18-35 years at risk of pregnancy and who are clients at Planned Parenthood clinics of Michigan (PPMI), who meet income eligibility criteria, and who would otherwise pay out-of-pocket for services on the day of recruitment (i.e., lacking insurance coverage for received service). The experimental (treatment) condition is a mother's receipt of a voucher providing access to no-cost contraception (up to the price of a name-brand intrauterine device) for 100 days. The control group of mothers receives no voucher. All enrolled women complete a two-part baseline survey and consent to be re-contacted for two follow-up interviews in outgoing years. They also complete a two-part baseline survey and consent to be re-contacted for two follow up interviews in outgoing years. In addition, mothers consent to linkages to their own and their children's administrative data from records held by state and federal health, education, criminal justice, and tax records. Consent covers children already born to women at the time of intervention and children born after intervention. Survey and administrative data provide outcome measures to assess children's well-being and development up to age 18. The study will compare children of mothers who receive the intervention to those who did not.

Eligibility Criteria:
Inclusion Criteria:

The proposed project will analyze the outcomes of children ages 0 to 17 years old whose mothers enrolled in the Michigan Contraceptive Access, Research and Evaluation Study (M-CARES). M-CARES participation requires that mothers are:

* 18-35 years old
* physically capable (biologically female and fecund) and at risk of having a pregnancy,
* not pregnant at the time of enrollment
* not wishing to become pregnant in the 12 months after enrollment,
* are seeking care at Planned Parenthood of Michigan, and
* face out-of-pocket costs for contraceptives at Planned Parenthood of Michigan.
Resuscitation Outcomes in the Netherlands Flashmob Questionnaire

The aim of this study is to gain insight in patients' experiences regarding do not resuscitate conversations and decisions. A multicentre flash mob investigation will be conducted in which data will be obtained over the course of two weeks using electronic questionnaires that patients will fill out. General demographic data and a brief quality of life assessment (EQ-5D) will be collected. Whether a DNR converstation has taken place will be noted, along with patients' experiences with this conversation. Lastly the patient will be asked about his/her expectations of survival after cardiopulmonary resuscitation.

Rationale: In-hospital cardiac arrest, associated with a survival to discharge of 15.0%, results in a good neurologic discharge in 9.1% - 30.0% of patients. Therefore it is recommended to engage in advanced care planning with patients, to discuss do-not-resuscitate (DNR) directives. In current knowledge, there are no published data about the prevalence of these DNR orders and associated factors in hospitalized patients in the Netherlands. Also, the conversation about DNR are sometimes perceived as awkward or untimely by patients.

Objective: The primary goal is to estimate prevalence DNR order in Dutch hospitals. A secondary goal is to assess what geographical, patient and disease factors are associated with DNR status. Furthermore patient experience in the conversation leading to DNR-orders is of interest.

Study design: A cross-sectional point prevalence study, in 10 participating hospitals of the ROUTiNE project.

Study population: Patients who plan to be admitted for more than 24 hours to the participating hospitals, aged 18 or older, who are responsive and conscious.

Main study parameters/endpoints: The prevalence of DNR orders, expressed as number per 1000 beds.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no risk. Only one ten-minute interview per participant. Therefore the benefit of this study (as described in the objectives) outweigh the potential risks.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the participating hospitals with a planned admission \>24 hours at the moment this study takes place.

Exclusion Criteria:

* • Refusal to participate

  * \<18 years of age
  * Admitted in outpatient clinic and day treatment centres (e.g. haemodialysis)
  * Admitted \<24 hours, as defined by not sleeping overnight in hospital
  * No reliable proxy in the following situations:

    * Unable to answer questions (e.g. unconscious, cognitively impaired, delirious)
    * Language barrier (with no interpreter or family member)
  * The following hospital departments are excluded:

    * Intensive care unit
    * Coronary/acute cardiac care unit
    * Obstetrics
    * Paediatrics
    * Stroke unit
    * Dialysis (outpatient dialysis)
    * Day-care wards/short-stay (i.e. \<1 day)
    * Palliative care
Positron-Emission Tomography With Vesicular Monoamine Transporter Ligand ([18F]-DTBZ) In Healthy Elderly And Young Subjects

A total 25 healthy subjects will be included in this study. Subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.

The primary objective of this protocol is to assess the possible age-dependent decline in striatal 18F-DTBZ uptake of healthy subjects.

This study is expected to be completed in a period of 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female age 20 years to 80 years.
2. Subjects without significant neuropsychiatric disorder after evaluation by Neurologist.
3. Subjects who provide a written informed consent prior to study entry. If the subject is incapable of informed consent, the caregiver may consent on behalf of the subject (the subject must still confirm assent).

Exclusion Criteria:

1. Pregnancy and breast feeding.
2. Significant recent (within 6 months) history of neurological (including stroke and brain trauma) or psychiatric disorder.
3. Alcohol or substance abuse within last year.
4. Parkinson's disease or other brain degenerative disease (spinocerebellar ataxia, Wilson's disease, hydrocephalus, multiple infarction, history of severe head injury or intracranial operation.
5. Unable to stay still in the MRI or PET scanner for 30 minutes.
NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery

This study is a prospective, single center, postmarket study to evaluate the safety and effectiveness of NeoPatch used as a tissue cover in foot and ankle tendon revision and repair surgery.

This study is a prospective, single center, postmarket study to evaluate the safety and effectiveness of NeoPatch used as a tissue cover for chronically injured tendons requiring surgical revision. NeoPatch is a tissue covering derived from terminally sterilized, dehydrated human placental membrane tissue comprised of both amnion and chorion. Candidates for this study are patients presenting with chronic tendon pain that are being evaluated for primary tendon revision surgery following failure of standard of care or immediate need for surgery, as determined by the investigator. Consented patients will receive NeoPatch as an adjunct to their foot or ankle tendon revision; NeoPatch will be wrapped around the tendon immediately prior to closure. The study will be divided into two phases: Screening and Follow-up. The study will include prospective patient evaluations at scheduled clinic visits and ultrasound appointments for a maximum of 12 visits over 12 months. Patient history, medications, self-reported pain, tendon status, and adverse events will be collected on all patients consented and enrolled into the study.

Eligibility Criteria:
Inclusion Criteria:

* Chronic tendinopathy requiring surgical revision in the opinion of the Investigator as defined in Appendix G.
* Intention to schedule surgical revision.

  ≥ 18 years.
* Free from clinical signs of infection at time of screening and at time of surgical intervention.
* Target tendon is one of the following: Achilles, Extensor Digitorum Longus, Extensor Hallucis Brevis, Extensor Hallucis Longus, Flexor Digitorum Longus, Flexor Hallucis Longus, Tibialis Anterior, Tibialis Posterior, Peroneus Longus, Peroneus Brevis, Peroneus Tertius.
* Able and willing to provide consent and comply with protocol.

Exclusion Criteria:

* History of surgical intervention involving target tendon.
* Tendon injury is acute in nature.
* Current participation in another clinical study.
* Currently receiving radiation or chemotherapy.
* Diagnosis of autoimmune connective tissue disease requiring systemic immunomodulatory therapy; stable NSAID doses for mild rheumatoid arthritis permitted.
* Use of biomedical growth factor within previous 30 days.
* Pregnant or breastfeeding or planning on becoming pregnant or unwilling to use medically acceptable methods of birth control.
* Taking medications considered to be immune system modulators within previous 30 days.
* Patient taking specific Cox-2 inhibitors within previous 30 days.
* Currently being treated with an investigational device or drug (within 3 months prior to surgery).
* Allergy, intolerance or hypersensitivity to any components or packaging of the product.
Ridge Preservation Comparing an Intrasocket Graft Alone to an Intrasocket Graft Plus a Facial Overlay Graft

The purpose of this study is to compare two methods of ridge preservation in the maxillary anterior esthetic zone to determine the best method to establish adequate bone and soft tissue to accommodate implant placement. For the positive control group a mineralized cancellous allograft will be placed in the extraction socket. For the test group a mineralized cancellous allograft will be placed in the extraction socket plus an additional graft will be placed to overlay the facial surface of the socket that will be composed of bovine xenograft material. Outcomes will be clinical horizontal and vertical dimensional change and histologic analysis of the graft material at 4 months post-placement.

Subjects met the eligibility criteria if they were at least 18 years of age and had one nonmolar tooth requiring extraction that would be replaced by a dental implant. Extraction sites were bordered by at least one tooth. Exclusion criteria included: 1) debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium; 2) molar extraction sites; 3) presence of or history of osteonecrosis of the jaws; 4) history of IV bisphosphonate treatment; 5) history of oral bisphosphonate treatment for more than three years; 6) pregnancy or lactation; 7) known allergy to any material or medication used in the study; 8) required antibiotic prophylaxis; 9) previous head and neck radiation therapy; 10) history of chemotherapy in the last 12 months; 11) long term steroid or non-steroidal anti-inflammatory drug therapy; or 12) failure to sign an informed consent approved by the Human Studies Committee. Patients were excluded post-treatment if they developed infection or had an adverse reaction to any of the materials used in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
2. Healthy person that is at least 18 years old.
3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
2. Molar teeth.
3. Presence of or history of osteonecrosis of the jaws.
4. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of the duration.
5. Patients who have been treated with oral bisphosphonates for more than three years.
6. Pregnant women due to the possibility of miscarriage.
7. Patients with an allergy to any material or medication used in the study.
8. Patients who need prophylactic antibiotics.
9. Previous head and neck radiation therapy.
10. Chemotherapy in the previous 12 months.
11. Patients on long term NSAID or steroid therapy.