cyrilzakka/clinical-trials huggingface dataset:
Residential MapTrek- Increasing Physical Activity Among Older Adults in a Residential-Living

Older adults are a growing population, with projections to reach 83.7 million by 2050. Furthermore, older adults are the most sedentary and least physically active adult population. It is estimated that nearly 90% of older adults 65 years of age or older do not meet the recommended levels of physical activity. Evidence suggests great health benefits can be achieved for older adults who are the most sedentary, and that replacing sitting with even light intensity walking can be beneficial.

The overarching goal of the project is to develop an inexpensive and scalable tool to increase volume of physical activity in our target population, older adults living in a residential facility. MapTrek is a web-based application that allows participants to take a virtual walk in interesting locations around the world while tracking their progress against the progress of other older adults living in a retirement community. Steps are counted using a commercially available accelerometer (e.g., Fitbit), and participants see their progress overlaid on Google Maps.

All participants will be provided with a Fitbit activity monitor and instructed to wear it 24 hours/day (except for bathing/swimming time) on their wrist for 12 weeks. Participants will participate in four team-based walking races, each two weeks long. Participants will view their team progress on TV monitors placed in various locations at the Oaknoll facility. The Oaknoll leadership has given the research team approval to do this at their facility. The monitors will present aggregated team data and will not report any individual data that could link back to the individual participant.

At the end of the 8 week active intervention, research team members will meet with participants at Oaknoll to administer an exit/process evaluation survey. The exit survey will ask about psychosocial predictors of physical activity as well as participants thoughts and opinions of the MapTrek game. This survey should take approximate 10-15 minutes to complete. The participants will then be asked to wear the Fitbit for four more weeks without playing MapTrek, which will act as a control condition since this is a single-arm study.

The specific aims of the study are:

1. To determine the efficacy of MapTrek for improving physical activity levels of older adults living in a residential facility from baseline to 8 weeks.
2. To determine the efficacy of MapTrek for improving psychosocial outcomes(e.g., self-efficacy, social support, outcome expectations, social isolation) among older adults living in a residential facility from baseline to 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible, participants much be between 25 and 100 years of age, physically able to walk without limitations

Exclusion Criteria:

* Patients with cognitive or physical limitations that prohibit walking and visual or cognitive impairments causing inability to read.
Self-Hypnotic Relaxation Therapy During Invasive Procedures

The purpose of this study is to determine the effectiveness of self-hypnotic relaxation on mental and physical distress during and after tumor treatment procedures.

Pain relievers and sedatives may have limited effectiveness and serious side effects when given to alleviate distress during minimally invasive surgical procedures. Unabated distress may interfere with the ongoing procedure and may negatively impact future interventions.

Studies have shown that nonpharmacologic analgesia in the form of self-hypnotic relaxation during invasive medical procedures significantly reduces patients' pain, anxiety, drug use, and number of complications. The long-term goal of this study is to determine whether self-hypnotic relaxation therapy can be a safe and practical method for reducing cognitive and physiologic distress associated with invasive procedures.

Participants in this study will be randomly assigned to one of three groups: a standard care group, an empathic control group, and a self-hypnotic relaxation group. The emphatic control group will meet with a clinician who will offer encouragement and support. The group assigned to self-hypnotic relaxation will read a standardized script prior to procedure. Self-report questionnaires will be used to assess pain and anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Referred for transcatheter embolization for benign uterine fibroid tumor or radiofrequency ablation or chemoembolization for malignant tumors
* Able to hear and understand English

Exclusion Criteria:

* Impaired mental function
* Psychosis
* Severe chronic obstructive pulmonary disease
* Intolerance of midazolam or fentanyl
* Weigh less than 121 lbs
* Pregnancy
Asthma and Allergy Screening AA2000 (Cross Sectional)

Asthma screening of 493 asthma patients

Questionnaire, and testing

Eligibility Criteria:
Inclusion Criteria: respiratory symptoms suggestive for asthma -

Exclusion Criteria:COPD

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GIA in Cascade Testing

The objective of this pilot study is to evaluate the feasibility and acceptability of GIA in sharing genetic test results with family members.

To determine the utility of GIA in sharing information. To determine the impact of GIA on downstream cascade testing rates.

Chatbots, also known as conversation agents, are programs designed to have interactive conversations with humans. While traditionally used in sectors such as online gaming and customer service, chatbots have made their way into a number of industries including healthcare and have shown promise in areas such as managing anxiety/depression, weight loss, and medication adherence. GIA (Genetic Information Assistant) is a chatbot specifically designed as a tool for patients to use for disseminating genetic results, education, and genetic counseling resources to their family members after they themselves receive a positive result.

Patients receive a secure GIA link from their provider and then are able to send their relatives the link to GIA through texting, email, and/or Facebook messenger. Once a relative clicks on the provided link, GIA's platform is structured as a decision tree, allowing family members to construct a personalized conversation about their family member's test results. This can be done either on a smartphone or computer. GIA provides basic genetics education and risk assessment and connects family members with local genetic counseling resources to continue this conversation and/or go forward with genetic testing. At the end of the conversation, the family member has the option of having a transcript sent to them via email for their reference. The objective of the current study is to evaluate the application of GIA for cascade testing in newly identified high risk breast and gynecologic mutation carriers.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Undergoing genetic testing at UVA for a personal or family history of breast or gynecologic cancers in Cancer Genetics.

Exclusion Criteria:

* Not receiving treatment at UVA
* Not English literate
* Unable to provide consent
MRI Evaluation of Change in Gluteal Muscles Following the Treatment With HIFEM Device

This study will use magnetic resonance imaging (MRI) to evaluate changes in gluteal muscle following the treatment with HIFEM stimulation for aesthetic improvement of buttocks.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21 years
* Voluntarily signed informed consent form
* BMI ≤ 30 kg/m2
* Women of child-bearing potential are required to use birth control measures during the whole duration of the study
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
* Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion Criteria:

* Cardiac pacemakers
* Implanted defibrillators, implanted neurostimulators
* Electronic implants
* Pulmonary insufficiency
* Metal implants
* Drug pumps
* Malignant tumor
* Fever
* Pregnancy
* Breastfeeding
* Following recent surgical procedures when muscle contraction may disrupt the healing process
* Application over areas of the skin which lack normal sensation
* Scars, open lesions and wounds at the treatment area
* Unrepaired abdominal hernia
DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial

The purpose of this study is to monitor trochanteric fracture healing and review the performance of the ATN system.

Proximal femoral fractures are among the most common femoral fractures. In the past plates and screws were often used to repair these fractures but this treatment had limitations including restricted weight bearing. Intermedullary nailing is an alternative to plate and screw treatment. Weight bearing is allowed and the procedure can be a less invasive. Among intramedullary nailing complications are iatrogenic fractures that can be further divided into trochanteric and femoral shaft fractures. Trochanteric fractures often heal without additional intervention however femoral shaft fractures usually require an additional surgical procedure to facilitate healing. This study will monitor fracture healing using clinical and radiographic evaluations of subjects with trochanteric fractures of the proximal femur treated with the ATN system.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and willing to sign the approved consent form.
* 18 years of age
* Skeletally mature
* Have stable or unstable proximal femur fracture, including pertrochanteric, intertrochanteric, high subtrochanteric or any combination of the AO Proximal Femur Fracture Classification

Exclusion Criteria:

* Subjects with concomitant lower extremity injuries or multiple trauma that would interfere with normal hip fracture rehabilitation.
* Subjects who have isolated or combined medial femoral neck fractures.
* Subjects who are unwilling or unable to comply with a rehabilitation program or are unwilling or unable to be assessed for 1 year following surgery.
* Subjects who are pregnant or breastfeeding.
* Subjects who are a prisoner or a known alcohol or drug abuser.
* Subjects who have a prior surgical history in the affected hip, or conditions that may interfere with outcome or impede healing.
* Subjects who have an obliterated medullary canal or other conditions that may complicate the reaming process.
* Subjects who have evidence of active untreated infections that may spread to other areas of the body.
* Subjects who have a highly communicable disease or pathology that may limit follow-up.
* Subjects, who in the opinion of the Clinical Investigator, have an existing condition that indicates the Subject is not a good candidate for the study.
* Subjects who are participating in another clinical investigation.
* Subjects known to have allergies to titanium, aluminum, vanadium.
* Subjects who are currently eligible for workman's compensation.
Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia

The aim of study is to evaluate the efficacy and safety of the new generic formulation (rosuvastatin orally disintegrating tablet (SUVARO®ODT) in patients with dyslipidemia.

STUDY OBJECTIVES: The aim of study is to evaluate the efficacy and safety of the new generic formulation (rosuvastatin orally disintegrating tablet (SUVARO®ODT) in patients with dyslipidemia. Also, this study is designed to observe patients' preference and adherence for SUVARO®ODT.

HYPOTHESIS: We hypothesized that there will be no difference in LDL-C lowering efficacy of the two formulations (SUVARO®ODT 10-mg or rosuvastatin Immediate-release tablet (IR) 10-mg).

STUDY DESIGN: This is a randomized, multicenter, open-label, two-period crossover study with 112 enrolled patients.

Subjects: Patients with dyslipidemia over 50 years of age who received statin treatmen for at least 2 months

Eligibility Criteria:
Inclusion Criteria:

1. Patients with dyslipidemia over 50 years of age who received statin treatmen for at least 2 months
2. Written informed consent to participate in the trial

Exclusion Criteria:

1. History of previous hypersensitivity reaction to other statins, including rosuvastatin
2. patients with acute arterial disease within 3 months
3. Uncontrolled Hypertensive Patients defined as SBP ≥180 mm Hg and DBP ≥110 mm Hg, respectively
4. Uncontrolled diabetes mellitus (HbA1c \> 9%)
5. Uncontrolled hypothyroidism defined as TSH \>1.5 within the last 6 months
6. Taking other lipid lowering agent except statins
7. History of statin-induced myopathy, rhabdomyolysis
8. Patients with severe hepatic or renal dysfunction
9. BMI (body mass index) \> 40 kg/m2
10. history of galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
The Efficacy of Liposomal Bupivacaine in Ultrasound Guided Supraclavicular Nerve Blocks for Hand and Wrist Surgery

Patients undergoing hand, wrist, and elbow surgery may experience pain after surgery. The orthopedic surgeon may provide prescription pain medications after surgery to assist with pain control. However, with concern of the opioid epidemic, many patients would rather minimize the use of narcotic pain prescriptions after having surgery. As an alternative, ultrasound guided regional nerve blocks can assist with postoperative pain control.

patients consented to this study will be randomized into three groups: 1) will receive an ultrasound guided nerve block with local anesthesia only, 2) will receive an ultrasound guided nerve block with local anesthesia and a steroid dexamethasone, 3) will receive an ultrasound guided nerve block with liposomal bupivacaine.

our study team will make phone calls after surgery to the patient to determine how long the block lasted for, and how many opioid pain pills were taken up to 3 days after surgery.

Our study team predicts that the ultrasound guided nerve block with liposomal bupivacaine can last approximately 48 hours, while the block with local anesthesia and dexamethasone will last approximately 30 hours, and the block with local anesthesia only may last up to 24 hours

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo finger, hand, wrist, elbow surgery with a hand surgeon at St. Luke's University Hospital in Bethlehem, Pennsylvania
* patients greater than 18 years of age, able to provide written consent for surgery and study

Exclusion Criteria:

* patients that cannot provide written consent for finger, hand, wrist, elbow surgery
* patients with known allergies to local anesthetics
* patients with severe liver disease
* patients with a condition known as methemoglobinemia
FREnch Survey on Heart Failure

Heart failure is the most common heart disease with increasing incidence due to the aging of the population is improving the initial prognosis of various conditions that lead to more or less progressive heart failure.

Heart failure is of great variety of clinical and pathophysiological forms necessitating the creation of quality records to clarify each of these forms.

Many types of cardiomyopathies exist, some of which are infrequent but with specific care.

At the French level, few data exist. In addition, the therapeutic management changes regularly.

New European recommendations (endorsed by the French Society of Cardiology = FSC) were published in May 2012. Many therapeutic approaches are being evaluated. The course of care and how to take non-drug load (network monitoring, rehabilitation ...) have become important issues that have hardly been analyzed by existing records.

This also leads to better define the different forms of this disease, their natural history and methods of management applied in real life. The register of FSC follows the registry of the European Society of Cardiology (ESC)"Heart Failure (HF) Long Term" (CCTIRS No. 11.355bis) with inclusions will be completed in November 2012. This new study aims to generate more accurate data on a number of points and be more representative for a wider selection of patients, the French level.

The recruitment period will be 24 months, with a day of inclusion for each week, which will be included both patients external consultant for chronic heart failure patients hospitalized in the cardiology department, during this day for acute heart failure.

Monitoring will be carried out 12 months during a consultation normally scheduled for this type of pathology with the cardiologist investigator. Patients included in a decompensation will also follow up to 3 months

Eligibility Criteria:
Inclusion Criteria:

* patient with chronic HF OR patient hospitalized foor acute HF de novo or not
* patient who accept to participate by signing a informed consent

Exclusion Criteria:

* patient who deny to participate
Safety Study on a Wood-plastic Composite Cast

An ecologically friendly and biodegradable wood-plastic composite-cast is studied. Patients, who has sustained a distal radius fracture in need of splinting are requested to participate in the study.


Eligibility Criteria:
Inclusion Criteria:

* distal radius fracture not older than 14 days
* age 17-90 years
* mother tongue finnish or swedish

Exclusion Criteria:

* open fracture
* other fractures or a previous fracture
* a previous or simultaneous tendon-, nerve- or vascular injury to the upper extremity
* a multiple injured hand
* decreased co-operation of the patient
* malignancy
* an illness affecting the general health
Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up

The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment


Eligibility Criteria:
Inclusion Criteria:

* Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on either the full face or a contiguous area of approximately 250 cm2 (40 in2) on the chest
* Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 in2). The tracking area must be within the treatment area

Exclusion Criteria:

* Location of the treatment area (full face or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
* Treatment with ingenol mebutate gel in the treatment area within the last 12 months
* Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
* History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum)
Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.

Background Preterm infants often need respiratory support. HFNV is a non-invasive method with benefits over CPAP, such as reduced nasal trauma and improved feeding.

Aim Study the impact of low (2 LPM) vs. high (6 LPM) HFNV flow rates on CO2 levels in preterm infants.

Methods Design: Prospective, crossover observational study. Participants: Preterm newborns (24-33.6 weeks' gestation) on HFNV. Procedure: Randomized flow rate adjustments, monitoring tcCO2 and other respiratory parameters over three hours.

Outcomes Primary: Change in tcCO2. Secondary: Study terminations due to unsafe CO2 levels and changes in other respiratory metrics.

Statistical Analysis Sample size: 45 infants. Analysis: Paired and unpaired t-tests for comparison within and between groups.

Background:

Preterm Births: About 10% of births are preterm, with infants at risk for respiratory distress.

Respiratory Support: Endotracheal ventilation has improved survival but increased the risk of bronchopulmonary dysplasia.

Non-Invasive Support: Nasal CPAP minimizes complications. Heated, humidified high-flow nasal ventilation (HFNV) is an alternative, providing advantages like reduced nasal trauma and improved oral feeding.

Aim:

Primary Goal: Examine changes in transcutaneous CO2 (tcCO2) levels in preterm infants when using HFNV at low (2 LPM) versus high (6 LPM) flow rates.

Hypothesis: Different HFNV flow rates will show minimal change in tcCO2 (≤5 mmHg).

Methods:

Design: Prospective, crossover observational study in Rambam NICU. Participants: Preterm newborns (24-33.6 weeks' gestation) needing HFNV. Inclusion Criteria: Stabilized HFNP settings and tcCO2, parental consent. Exclusion Criteria: Specific flow and CO2 levels, unstable conditions, or congenital malformations.

Procedure: Randomize infants into two groups starting with 2 or 6 LPM flow rates, monitoring tcCO2 over three consecutive hours with alternating flow rates.

Measurements:

Primary Outcome: Change in tcCO2 levels. Secondary Outcomes: Number of study terminations due to pCO2/TcCO2 out of safety range, changes in respiratory parameters, and episodes of desaturation or bradycardia.

Statistical Analysis:

Sample Size: 45 infants needed to detect no difference with 90% power and 5% significance level.

Data Analysis: Use paired and unpaired Student's t-tests to compare results within and between groups.

Safety Protocol: The study will terminate if significant desaturation, bradycardia, or pCO2 levels outside the safety range occur.

Eligibility Criteria:
Inclusion criteria:

* Gestational age 240 to 336.
* At least 6 hours of stabilized HFNP settings, i.e. minor changes in settings (FiO2 ≤0.10, no change in flow).
* At least 6 hours of stabilized tcCO2, i.e. ≤5 mmHg variation.
* At least 6 hours from surfactant administration.
* Parental consent

Exclusion criteria:

* If flow is \&lt;3 and tcCO2 related pCO2 is\&lt;40mmHg.
* If Flow is ≥5 bpm and tcCO2 related pCO2 is\&gt;60mmHg.
* Unstable infants due to acute conditions (sepsis. IVH), or congenital malformations.
Fetal Blood Flow Response to Partial Occlusion by External Compression

Two earlier studies showed measurable fetal hemodynamics changes caused by external pressure induced by te abdominal ultrasound transducer. The investigators would like to study the response of flow in main fetal vessels to different, mild to moderate pressures induced by the abdominal transducer. The pressure induced by the transducer will be measured by a digital computed manometer. The flow chances in fetal vessels will be measured by ultrasound Doppler. Measurements will be taken on different pregnancy weeks, on one occasion in each pregnant woman. Ones without applying transducer pressure (control) and ones after applying mild pressure.


Eligibility Criteria:
Inclusion Criteria:

singleton

Exclusion Criteria:

multiple gestation