cyrilzakka/clinical-trials huggingface dataset:
Preventing American Indian Children From Becoming Overweight

The purpose of this study is to establish an intervention to keep American Indian/Alaskan Native (AI/AN) children from becoming overweight.

BACKGROUND:

AI/AN children have overweight rates that are 18 to 30 percent higher than the general American population of children. Adult obesity has early antecedents, and data show that eating and physical activity behaviors are formed and set as early as 3 years of age, through primary socialization within families. Yet there are few, if any, obesity prevention programs that target children younger than 3 years of age.

DESIGN NARRATIVE:

This is a community-partnered randomized study to prevent early childhood overweight in AI/AN children. A birth cohort of about 780 children from six Indian communities born over a period 18 months will be randomized by community to either a control (3 communities) or intervention condition (3 communities). The intervention comprises a community-wide intervention coupled with individualized family counseling to improve nutrition and physical activity in infants and toddlers. Nutrition goals are to increase breastfeeding initiation and sustainability, limit sugared beverages for infants and toddlers, and make healthful choices during weaning and solid food introduction. Physical activity goals include promoting motor development, limiting video/TV viewing, and creating play opportunities for infants and toddlers. Intervention approaches and methods used in the pilot study on which this project is based will be combined with new formative data collected at the beginning of the project to enhance the intervention's feeding and physical activity components. Each component in the community-wide interventions will be collaboratively designed with the tribes, and tailored to each community's needs. Trained peer counselors will deliver the family interventions, during a series of 12 cluster visits, each covering a different developmental stage of the infant/toddler.

Eligibility Criteria:
Inclusion Criteria:

* Women who have had uncomplicated pregnancies
* Women who agree to have their child enrolled in the study and followed for 30 months
* Women who are not planning to leave their area within 2 years of study start

Exclusion Criteria:

* Women whose children have a serious illness known to affect normal growth
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

This randomized, double-blind, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate. All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks plus oral methotrexate for 16 weeks. Patients achieving low disease activity at Week 16 will be randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus either methotrexate or placebo. Anticipated time on study treatment is 28 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Active moderate to severe rheumatoid arthritis (DAS28 \>/= 3.2) at baseline
* Currently receiving methotrexate for at least 12 weeks, at a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1)
* Body weight \< 150 kg
* Oral corticoids must have been at stable dose for at least 25 out of 28 days prior to baseline; maximum dose 10 mg/day

Exclusion Criteria:

* Pregnant or nursing women
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
* Rheumatic autoimmune disease other than RA
* Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
* Prior history of or current inflammatory joint disease other than RA
* Treatment with a biologic agent at any time prior to baseline
* Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
* Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
* Previous treatment with RoActemra/Actemra
* History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
* Known active current or history of recurrent infection
* History of or currently active primary or secondary immunodeficiency
* Active tuberculosis requiring treatment within the previous 3 years
* Positive for HIV infection
A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery

The purpose and objectives of this study is to investigate whether reducing the existing arm restrictions on patients who receive Cardiac Implantable Electronic Devices (CIED) will result in an improved patient experience post operatively and reduce complication rates. There are multiple and varied arm restriction instructions given to patients receiving CIED's with limited universally accepted protocols or advice on restrictions for patients following surgery.

Restrictions such as arm immobilization, showering and weight lifting, in addition to contradictory advice between various hospitals and physicians, can negatively affect patient quality of life and increase patient anxiety with no current evidence for benefit. A cluster cross over randomized trial has been designed to test the comparative effectiveness of lenient vs strict arm restrictions for all patients receiving implantable devices.

Instructions within both arms of this study are considered within reasonable practice in Canada.

All arm restriction instructions and parameters will be embedded within EPIC, nurses will teach the restriction in addition they will be provide to the patients via printed EPIC discharge summaries. Further links will be embedded in the After Visit Summary (AFS) printouts and my Chart for patients in EPIC. These instructions will be changed every 7 months, as per the crossover design of the trial. Additionally, both arms will utilize interactive voice recognition (IVR) to provide patients with further reminders and instruction on arm restrictions.

All patients are given standard of care instructions for follow up and complication assessment through our device clinic and 24/7 on call nursing program.

The purpose and objectives of this study is to investigate whether reducing the existing restrictions on patients post CIED will result in an improved patient experience post operatively and reduce complication rates. Results from this study will create standardized, postoperative arm restriction recommendations more uniform between various hospitals.

Hypothesis: The investigators hypothesize that outcomes of the post CIED implanted patients given lenient arm restriction will be non-inferior to those with prolonged arm restriction at reducing a combined primary endpoint of lead dislodgement, device infection, clinically significant pocket hematoma, upper limb DVT and frozen shoulder.

Clinical relevance: The investigators anticipate that patients with minimal (lenient) arm restriction will have similar postoperative complication rates compared to the prolonged arm restriction. Should this hypothesis be proven, this will greatly improve patient quality of life post CIED with less stringent restrictions.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing device surgery which includes implantation of at least one new endovascular lead

Exclusion Criteria:

* Standalone CIED generator replacement
Intravitreal LFG316 in Patients With Age-related Macular Degeneration (AMD)

This study was conducted in two parts; Part A and Part B: Part B was initially planned to include two cohorts. Cohort 2 was cancelled following an interim analysis for efficacy in Part A of the study, and not due to any safety issues or concerns. Cohort 2 is not referred to again and part B cohort 1 is referred to as part B alone in the remainder of the document and is the subject of this report.

Part B was conducted to assess the safety and tolerability of a single intravitreal (IVT) LFG316 10 mg/100 µL injection. There was no efficacy evaluation in Part B. The study employed a multicenter, randomized, sham - controlled, single masked design. Eight patients with advanced AMD were planned to be randomized in a 3:1 ratio to receive a single IVT dose of LFG316 (10 mg/100 µL) or sham injection. Patients assigned to a sham injection were treated the same as those assigned to LFG316, except that the hub of an empty syringe (without needle) was placed against the eye instead of the IVT injection.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AMD if enrolled in Part B of study
* Geographic atrophy in at least one eye if enrolled in Part A of study
* ETDRS best corrected visual acuity of 60 letters or worse (\~≤ 20/63)

Exclusion Criteria:

* Retinal disease other than AMD
* History of choroidal neovascularization
* Severe cataract
* History of infectious uveitis or endophthalmitis
* Eye surgery in the non-study eye within 30 days prior to study
* Eye surgery or IVT injection in the study eye within 90 days prior to study
* Other protocol-defined inclusion/exclusion criteria may apply
Sandplay Activity in Psychiatry Clinic (SAPC)

This research was conducted to examine the effect of sandplay activity on anxiety and well-being levels in patients in psychiatric clinics.

The research was carried out in Isparta Süleyman Demirel University Psychiatric Clinic as a single-blind randomized controlled experimental study in the pre-test, final-test order between 2020-2021. Ethical permission was obtained from the Clinical Research Ethics Committee and application permission from the institution for pre-research. 63 patients (intervention-32 and control-31) selected by block randomization method formed the universe of the study. No intervention was applied to the control group. A preliminary test and a final test were performed two days apart, one hour apart on the first and fourth days. Two sessions of sandplay activity were applied to the intervention group with a decongest of two days, and each session was pre-tested. The data was collected using "The Personal Information Form", "The Spielberger Status Anxiety" inventory, and "Well-Being Star Scale" and also data showed normal distribution. In statistical analysis, T-Test, Chi-Square Test, pearson correlation test was used dependent and independent groups.

For the purpose of the research, the hypotheses of the research are as follows::

1. Hypothesis (H1): after intervention, anxiety levels of patients who underwent sandplay activity (in a psychiatric clinic) are lower than in the control grouproup
2. Hypothesis (H1): after intervention the level of well-being of patients undergoing sand play activity (in a psychiatric clinic) is higher than that of the control group.
3. Hypothesis (H1): there is a negative correlation between the level of anxiety and the level of well-being in psychiatric clinics who sandplay activity is practiced and not practiced.

This research is Turkish language.


Eligibility Criteria:
Inclusion Criteria Being over 18 years old, Volunteering to participate, Not having a defect in the ability to evaluate and reason the truth, Not having hearing, understanding, and speaking problems, Not have a physical disability

Exclusion Criteria from Research To be involved in another study on a similar experimental subject Being on the first day of hospitalization and on the day of discharge

Removing Criteria State their willingness to leave the research voluntarily Transfer to another place and/or unscheduled early discharge
Innovative Approaches to Gauge Progression of Sturge-Weber Syndrome

This study has three aims that hope to expand the knowledge on the cause of Sturge-Weber Syndrome (SWS) and improve clinical care of Sturge-Weber Syndrome patients.

This study is one of three projects of an NIH Rare Disease Clinical Research Consortium focused on brain blood vessel malformations in three different rare diseases. The focus of this project is on Sturge-Weber Syndrome.

We plan to improve the future understanding and treatment of Sturge-Weber Syndrome by 1) establishing a national consortium database which will gather lager amounts of clinical data and serve indirectly as a registry to foster future clinical trials and determine the usefulness of urine vascular biomarkers to determine the vascular remodeling of the SWS birthmark and choroidal angioma, 2) study vascular remodeling with retrospective and prospective neuroimaging to determine the vascular remodeling of the deep draining intraparenchymal vessels as it relates to SWS neurologic status, and 3) relate the GNAQ mutation to altered phosphorylation of pathway proteins and angiogenesis factors in SWS tissue.

Eligibility Criteria:
Inclusion Criteria:

For Aim 1:

For main sample:

* Sturge-Weber syndrome
* Diagnosed brain Involvement

For Control:

* Family member of participating SWS patient

For OCT:

* Sturge-Weber syndrome eye involvement

For Aim 2:

* Sturge-Weber syndrome
* Diagnosed Brain Involvement

For Aim 3:

* Sturge-Weber syndrome
* Diagnosed brain Involvement
* Port-Wine Stain in V1 and/or V2 areas of face.

Exclusion Criteria:

* Not Diagnosed with Sturge-Weber syndrome with brain Involvement (or eye involvement for OCT)

For Aim 1:

* Family member must not have certain medical conditions. A list will be provided before consent is given.

For Aim 3:

* Not Diagnosed with Sturge-Weber syndrome with brain Involvement
* No Port-Wine Stain
Postoperative Pain Control Following Vitreoretinal Surgery

The aim of this study is to evaluate if patients receiving a steroid (triamcinolone acetonide) combined with local anesthesia and antibiotic following retina surgery have better postoperative pain control those receiving local anesthesia and antibiotic alone.

Currently, patients undergoing vitreoretinal surgery at the Emory Eye Center and Emory University Hospital receive a injection of local anesthesia behind the eye (retrobulbar) at the start of surgery to minimize discomfort felt during the surgery. At the end of surgery all patients receive a periocular antibiotic and steroid injection. Some patients also receive a retrobulbar injection of local anesthesia (bupivicaine) at the conclusion of surgery in order to decrease postoperative pain and discomfort.

It has been our observation that when the local anesthesia is combined with a steroid (triamcinolone acetonide) in a retrobulbar injection at the conclusion of surgery, patients tend to be pain free for longer intervals then when local anesthesia is used alone. The objective of this study is to evaluate if patients receiving triamcinolone acetonide combined with local anesthesia and antibiotic compared to those receiving local anesthesia and antibiotic alone do better with postoperative pain control.

All eligible patients undergoing vitreoretinal surgery at the Emory Eye Center and Emory University Hospital will be offered enrollment. About 60 patients will be invited to participate in this study. Patients will undergo standard of care surgery. At the conclusion of surgery, patients will receive a retrobulbar antibiotic and anesthetic as standard of care. Half of the patients will receive this mixture plus steroid and the other half will receive this mixture plus saline. On postoperative day 1, patients will be given a questionnaire to assess pain. Pain levels in the two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing vitreoretinal surgery at the Emory Eye Center Ambulatory Surgery Center and Emory University Hospital by retina attending faculty surgeons

Exclusion Criteria:

* Unable to verbalize level of pain control
* Pediatric patients (\<18 years old)
* Glaucoma, ocular hypertension, or glaucoma suspects
* Allergy to local anesthetic
* Pre-existing chronic pain requiring narcotic pain medication
* Drug addiction
* Impaired periorbital sensation (history of herpes simplex, zoster, corneal graft)
Developing a Peer Support Intervention for Depression in SCD

The purpose of this study is to assess the feasibility, acceptability, and fidelity of an 8-week intervention where peer coaches will deliver depression care to adults 60 years of age or older who have depression and subjective cognitive decline.

With support from the MADRC ORE Core, we will recruit 30 community-dwelling older adults to conduct an open pilot study of PeersCOG. Trained and supervised peer coaches will deliver depression care to adults 60 years of age and older with depression and subjective cognitive decline in an 8-week intervention using video chats and texts. We will use mixed methods to assess feasibility, acceptability, and fidelity. We will use validated instruments to assess the preliminary outcomes, including depression, SCD, functioning, and social factors at baseline, 8 weeks, and 3 months, and we will conduct post-intervention interviews with stakeholders at 8 weeks. Older adult participants will be asked to name a study partner who will support the older adult throughout the study in terms of study enrollment. They may also have additional perspectives on the impact of impaired cognition and depression on daily living and related needs. The older adult will not be excluded if the study partner is not available.

Eligibility Criteria:
Inclusion Criteria:

* Older adults aged 60+
* Endorse subjective cognitive decline
* Endorse depressive symptoms
* not currently experiencing suicidal ideation nor active, untreated manic, psychotic, or substance use disorder
* fluent in English and able to give informed consent

Exclusion Criteria:

* Meets diagnostic criteria for mild cognitive impairment or Alzheimer's dementia
* Meets diagnostic criteria for a current major depressive disorder
* have a history of neurological and psychiatric comorbidities such as major depressive disorder in the past 12 months
Neuroimaging MAO-B in Medication Free TR-MDD Using Novel Tracer

The purpose of this study is to determine if monoamine oxidase B (MAO-B) total distribution volume (VT), after phenelzine treatment and if so to what extent.

Subjects will receive a PET and MRI scan before and after treatment with phenelzine.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age
* good physical health
* Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of current major depressive episode (MDE)
* DSM-IV diagnosis of major depressive disorder (MDD) verified by SCID for DSM-IV and a psychiatric consultation
* greater than 17 on the 17 item HDRS (Hamilton Depression Rating Scale).
* history of non-response to several different antidepressant classes

Exclusion Criteria:

* herbal, drug or medication use (that affect CNS function)
* suicide attempts
* drug or medication use within eight weeks (+5 half lives of medication)
* history of substance abuse or any neurotoxin use
* history of psychotic symptoms
* history of central nervous system (CNS) medical illness
* current substance abuse
* test positive on pregnancy test (for women)
Assessing the Tendons With Shear Wave Elastography

The purpose of this study is to utilize Shear Wave Elastography (SWE) to study the viscoelastic properties of tendons to understand the functional differences between normal/asymptomatic and symptomatic tendon states. The study will also assess the degree of tendon healing following standard of care treatment.

Tendinopathy is a common affliction in athletes, recreational exercisers, the general population and even inactive people. Tendon pathology presenting clinically is most commonly seen in the chronic state related to tendon degeneration manifested as intra-tendinous mucoid degeneration and chondroid metaplasia, which in many cases is accompanied by superimposed small intrasubstance/interstitial tears. Then a vicious cycle of attempted inadequate healing with superimposed acute pathology ensues leading to significant pain and discomfort over time significantly limiting physical activity. The exact pathogenesis of this disease has not been clarified scientifically.

The first part of this study aims to establish the difference between asymptomatic and symptomatic tendons among patients affected by moderate-to-severe, chronic (\>6 months of symptoms) tendinopathy in comparison to asymptomatic patients. After establishing a range of elastography normal to severe pathologic measurements, a second part of the study will focus on utilizing ultrasound elastography imaging follow up to assess degree of tendon healing after various standard of care treatments.

The purpose of this prospective observational study is to utilize a ultrasound modality known as real-time Shear Wave Elastography (SWE) to study the viscoelastic properties of tendons, such as the Achilles, patellar, quadriceps, epicondylar, and rotator cuff, to understand the functional differences between normal/asymptomatic (n=75) vs symptomatic (n=75) tendon states (total n=150). The secondary aim will be to assess the degree of tendon healing after standard of care treatment. The clinical implications are very significant because it will provide insights into the mechanism of tendon healing.

Eligibility Criteria:
Inclusion Criteria for Asymptomatic Volunteers:

* Patients presenting at the study location with lower extremity pain without tendon involvement

Inclusion Criteria for Symptomatic Volunteers:

* Patients presenting at the study location with a clinical diagnosis of tenalgia
* Diagnosis of tendinopathy confirmed by ultrasound

Exclusion Criteria:

* Pregnancy
* History of tendinopathy or surgery and morphologic abnormalities
* History of systemic, metabolic, endocrine diseases, or psoriasis
* History of treatment with corticosteroids, estrogens, long term quinolone antibiotics, and cholesterol drugs
Compassionate Use of Defibrotide for Patients With Veno-occlusive Disease of the Liver

Veno-occlusive disease (VOD) of the liver is a significant complication for some patients undergoing hematopoietic stem cell transplantation. This disease is thought to be a toxicity secondary to chemotherapy or radiation-induced damage to the epithelial cells of the blood vessels in the liver. VOD is categorized as mild, moderate or severe. Historically, there has been no method to treat the disease. Recently, however, there have been investigations into the use of a new agent called defibrotide.

The primary purpose of this protocol is to provide defibrotide to patients with severe VOD. Because this drug has not been approved by the FDA, use of this medication under the auspices of this IND treatment plan is for compassionate use only.

Secondary objectives of this protocol include the following:

* To describe the toxicities of defibrotide in patients with VOD.
* To describe the response rate of VOD in patients receiving defibrotide.

Eligibility Criteria:
Inclusion Criteria:

Patients with clinical or pathologic diagnosis of veno-occlusive disease. The following criteria will be used:

1. Hyperbilirubinemia (greater than or equal to 2mg/dl) and two of the following: (hepatomegaly, ascites, or weight gain \[greater than or equal to 5% of baseline\]); OR,
2. Patient who do not fulfill criteria in #1 but who have pathologic or radiographic evidence of VOD.