cyrilzakka/clinical-trials huggingface dataset:
Adaptive Arm Training for Children With Hemiplegia

The goal of this research is to provide limb training in children with hemiplegia using a bimanual-to-unimanual training approach. Twenty pediatric patients aged 5-17 years with acquired brain injury will receive training on the bimanual-to-unimanual device for a period of 9 weeks. During the training, children use both arms to operate robotic arms to play a video game. We will assess changes in hand impairment after the training.


Eligibility Criteria:
Inclusion Criteria:

* Hemiplegia due to brain injury at least 3 months before study enrollment.

Exclusion Criteria:

* Any social or medical problem that precludes compliance with the protocol.
* Treatment with botulinum toxin or intrathecal baclofen in the 3 months preceding enrollment.
* Implanted neuromodulatory or electronic device or other complicating illness.
Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

The overarching goal of this study is to adapt and feasibility test an evidence-based strengths-based case management (SBCM) intervention for pre-exposure prophylaxis (PrEP) initiation, and examine preliminary efficacy of the intervention comparators (SBCM-PrEP) and (Centers for Disease Control (CDC)-PrEP). Within this context, the Specific Aims are to: 1) Assess client, provider, organization, and structural-level facilitators and barriers to integration of a PrEP focused SBCM (SBCM-PrEP) intervention into routine syringe service program (SSP) practice; 2) Adapt an evidence-based SBCM protocol to provide PrEP intervention services for people who inject drugs (PWID) in SSP sites; and, 3) Examine feasibility, acceptability and preliminary efficacy of the adapted SBCM-PrEP. 80 participants will be randomized into: CDC-PrEP (an in-use PrEP intervention based on CDC guidelines) or SBCM-PrEP.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older;
* HIV-negative status;
* Past month drug injection;
* Client of SSP in targeted sites

Exclusion Criteria:

• HIV-positive status
Trial Evaluating the Effect of Facilitated Small Group Sessions on Physician Well-Being, Job Satisfaction, and Professionalism

The study purpose is to evaluate the effect of a small group discussion based intervention on physician well-being, job satisfaction, and professionalism. Participants will be put in one of 3 groups by chance (as in the flip of a coin). A computerized selection process will be used to assign participants to the study groups. There is a 1 in 3 chance of being assigned at random to either of the 3 groups.

The first study group will meet once every two weeks for 9 months (from September 2010 through June 2011) from 12:30 pm until 2:00 pm. These meetings will be small group discussion sessions with groups of no more than 15 participants. Lunch will be provided for the first 30 minutes, and group discussion during the next 1 hour will be guided by the session facilitator around such topics as work-life balance, meaning in work, medical mistakes, spirituality, and unmet patient needs. However, the discussions will be open forums, and the groups themselves will help decide on topics relevant to the group. The 1 hour of protected non-clinical time every other week required for this group will be funded by the study.

The second study group will also have 1 hour of protected non-clinical time provided every other week for the same 9 months. This study group will not participate in small group discussions, but may use the protected time for professional tasks as they wish.

Participants in the third study group will continue with their current work practices, but will be provided with protected time to complete study surveys. If group sizes are too small after recruitment to allow a complete study of all three groups, the third study group will be removed and participants will be randomly assigned to one of the first two study groups only.

Participants in all groups will be asked to complete a quarterly survey on well-being, job satisfaction, and professionalism. Follow-up surveys will also be administered 3 months and 1 year after the conclusion of the small group sessions. Each survey is expected to take approximately 20-30 minutes to complete.


Eligibility Criteria:
Inclusion Criteria:

* Senior Associate Consultant or Consultant in the Mayo Clinic Department of Medicine.

Exclusion Criteria:

* No clinical effort.
Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis

The purpose of this study is to detect new urinary biomarkers that can be used as predictors on renal function in congenital hydronephrosis caused by unilateral ureteral obstruction (UUO) and to elucidate the pathophysiology of UUO.


Eligibility Criteria:
Inclusion Criteria:

* Children referred to surgical treatment of congenital hydronephrosis caused by ureteral obstruction.
* Declining function of the hydronephrotic kidney more than 5 %, and to less than 40 % of the total renal function OR ipsilateral flank pain.

Exclusion Criteria:

* Bilateral hydronephrosis
* Previous operation in the urinary system except operation for phimosis and other deformations of the external genital organs.
* Deformations in the lower part of the ureter, bladder and urethra. Urinary stones. Reflux. Urinary tract infections \< 6 months.
* Neurogenic bladder dysfunction.
* GFR \< 40 % standardized to age.
* Non-compliance. Linguistic difficulties.
Natural History Study for Achromatopsia

In preparation for human clinical trials we intend to undertake a detailed phenotypic study to help to identify patients who may be suitable for therapeutic intervention. In addition, with the recent availability of advanced imaging modalities, further detailed phenotypic investigations will also be valuable in helping to probe the relationship between structure and function and may shed light on disease mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* Patients with molecularly proven Achromatopsia or a typical clinical Achromatopsia phenotype with genetic screening pending.
* Minimum subject age of 3 years.
* Able to give consent/parent or guardian able to give consent.

Exclusion Criteria:

* Patients unable or unwilling to undertake consent or clinical testing.
* Patients unwilling to donate a blood sample in order to establish the genetic cause of their condition.
Lung Ultrasonography After Major Cardiac Surgery

Diagnosis of pneumonia remains difficult in intensive care unit (ICU), notably after cardiac surgery. Lung ultrasonography (LUS) has been successfully used for diagnosis of pneumonia, but its usefulness and reliability was never evaluated after cardiac surgery. This study investigates the clinical relevance of LUS for pneumonia diagnoses in cardiac ICU.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery with sternotomy and cardio-pulmonary bypass (CPB) less than 3 days before
* At least one component suggestive of ARF:

  * If mechanical ventilation, a PaO2 / FiO2 ratio \<200, or failure of weaning (failure of spontaneous ventilation test, re-intubation in the first 24 hours), or need for non-invasive ventilation immediately after extubation,
  * If spontaneous ventilation: clinical signs of acute respiratory distress (dyspnea at least exertion, cyanosis, polypnea\> 25/min, upper or intercostal swallowing, abdominal swing ...), SpO2 \< 90% or PaO2 \<60 mmHg despite oxygen therapy ≥ 3L/min.

Exclusion Criteria:

* Minor patients
* Pregnancy
* Sleep apnea syndrome
* Participation refusal
Evaluation of an Interactive Opioid Risk Education Program (STOMP) for Parents

Millions of children and adolescents are prescribed opioid pain relievers each year, placing them at risk for serious adverse events and misuse in the home setting. Parents who manage these medicines, therefore, need to recognize opioid-related risks and make decisions that will both reduce these risks yet ensure effective pain relief for their children. The proposed research will evaluate new strategies to help parents learn about opioid risks, make safe and effective analgesic decisions, and develop and demonstrate safe drug management behaviors. 840 parents and their children who are undergoing an elective surgical procedure will be recruited. Parents will be randomized to receive the new educational and practical behavioral strategy or routine information. Parents' knowledge and perceptions will be evaluated at baseline and at critical times after surgery. Parents' opioid handling and administration will also be assessed.

The overarching goal of this research is to improve opioid analgesic safety and efficacy by optimizing opioid risk recognition, informed analgesic decision-making, and drug storage/disposal behaviors among parents of youth who are prescribed these agents for home use. The study aims are to determine whether the Scenario-Tailored Opioid Messaging Program (STOMP) will: 1) Improve parents' opioid risk understanding and their analgesic decision-making; 2) Enhance parents' analgesic self-efficacy, analgesic use, storage behaviors and their children's pain outcomes, and 3) To demonstrate that the STOMP plus provision of a simple method to get rid of left-over opioids will effectively nudge parents to safely dispose of left-over opioid analgesics. Parents whose children are prescribed opioids for acute, short-lived pain after surgery will be randomly assigned to receive our interventions or a routine provider informational interaction at the time of opioid prescribing. Parents will be surveyed about their opioid familiarity, knowledge, risk perceptions and common analgesic decision-making at baseline and after hospital discharge. Parents will also record their child's pain medication use and symptoms after discharge. Data will be analyzed to determine whether the STOMP educational intervention with or without the behavioral nudge intervention will enhance parents' risk perceptions, their decision-making skills and their opioid handling behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Parent (\>=21yr) and child (5-17 yr) (dyad) who lives in the home and is prescribed an opioid for postoperative pain management
* English speaking

Exclusion Criteria:

* Child is undergoing a non-elective procedure
* Child cannot self-report pain levels (i.e., is cognitively impaired)
* Child has a hematologic/oncologic condition
* Child has a kidney or liver conditions that precludes the usual analgesic prescription pattern (opioid plus a non-opioid)
* Child has been taking opioids for prolonged pain pre-operatively (\>2 weeks)
Sanomechanics® Rehabilitative Technology

Rehabilitative Sanomechanics Method (RSM) of exercise designed to restore normal subperiosteal transmission of in-joint pressures and normalizing contact pressures on cartilages, will reduce pain in the affected joints and improve locomotor function.

Specific Aim 1: In a clinical trial with subjects reporting arthritic knee pain, demonstrate that the Sanomechanics method of exercise, focused on restoring normal subperiosteal transmission of in-joint pressures, will reduce pain. Using the validated WOMAC questionnaire as a Patient- Reported Outcome (PRO) tool, the associated primary endpoint is that 80% of patients will report a reduction in pain at the end of the 3-month study based on the 5-point categorical WOMAC pain scale.

Specific Aim 2: To demonstrate that Sanomechanics will improve normal synergy in gait by mitigating compensatory gait strategy, which one develops to avoid unbearable pain in the joint. The associated co-primary endpoint is that 80% of patients will experience an increase in stance knee flexion angle. The secondary endpoint is that the 80% of patients will report a lowered WOMAC function score based on 5-point categorical WOMAC scale (lower score corresponds to better self-reported function) after the three-month study.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral knee pain with WOMAC score 6-9.
* Knee pain, aching or stiffness on most days in the past month and definite radiographic osteoarthritis in the index knee.
* Morning stiffness \>30 min.
* Age: 40-75 years of age.
* More pain in the morning compared to evening.
* English speakers.
* Have daily access to an email address and a computer with Internet
* Allowed to be on prescription or non-prescription medicine for pain during the course of the study.

Exclusion Criteria:

* Inability to communicate in English
* Lower limb injury, surgery, or intra-articular injection in the past 6-months
* Current pregnancy
* Have a pacemaker or other internal medical device
* Cancer not in remission
* Gout
* History of stroke affecting lower limb
* Major trauma
* Gross knee instability on exam
* Lumbar radiculopathy affecting symptomatic limb
* KL radiographic score 4
* Morphological indications (bone-on-bone contact) for joint replacement
Clinical Benefits of a Multimodal Physiotherapy Programme in Fighter Pilots With Flight-related Neck Pain

The aim of this study was to analyse the immediate effects of a 4-week multimodal physiotherapy program which combines cervical supervised exercises with laser-guided feedback (ELGF) and interferential current electro massage (ICE) in fighter pilots with flight-related neck pain.

Flight-related neck pain constitutes a clinical entity related to the performance and flight safety of fighter pilots. The aim of this study was to analyse the effectiveness of a multimodal physiotherapy program which combines supervised Exercise with Laser-Guided Feedback (ELGF) and Interferential Current Electro-Massage (ICE) in fighter pilots with flight-related neck pain.

31 pilots were randomly allocated into two groups (Experimental Group n=14; Control Group n = 17). The intervention consisted of 8 sessions (twice a week) for 4 weeks. As primary outcome measures the following variables were measured: perceived pain intensity (Numeric Pain Rating Scale) and neck disability (Neck Disability Index). The secondary outcome measures were: cervical range of movement (CRoM), joint position sense error (JPSE) and pressure pain threshold (PPT).

Eligibility Criteria:
Inclusion Criteria:

* Flight pilots (male and female) who, at the time of the assessment, were an instructor or student attached to the 23th Wing of Talavera Air Base, Spanish Air Force (SAF), Badajoz.
* Flight pilots diagnosed with flight-related neck pain according to the International Classification proposed by an expert panel of the North Atlantic Treaty Organisation (NATO).
* A minimum perceived pain of 3/10 on the Visual Analogue Scale (VAS) in the early-morning assessment.
* Scores of ≥5 points on the Neck Disability Index (NDI), and a cervical-repositioning error of ≥4.5°.

Exclusion Criteria:

* Cervical pain with radiation to the upper limbs and/or radiculopathy.
* Cervical spine surgery with or without the presence of a metal implant.
* Having received physiotherapy or any other routine medical care six weeks prior to data collection.
* Being involved in ongoing medical-legal conflicts.
Dexmedetomidine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain

This study aims to evaluate the role of dexmedetomidine as an adjuvant in external oblique intercostal plane block for post-thoracotomy pain.

External oblique intercostal plane block (EOIPB) is a novel block that has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls.

Dexmedetomidine is a selective alpha 2- adrenoceptor agonist possessing sedative, anxiolytic, and analgesic properties without the development of respiratory depression.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-III.
* Scheduled for open thoracotomy.

Exclusion Criteria:

* Patients with neurological or intellectual disability.
* Infection at the injection site.
* Drug abuse.
* Allergic reaction to local anesthetics.
* Coagulation abnormalities.
* Pregnancy.
* Body Mass Index (BMI) ≥35 kg/m2.
* Severe cardiovascular problems.
* Diabetic neuropathy.
Role of Pancreatic Triglyceride Content in Beta-cell Function

The study evaluates if fat accumulates in the pancreas in individuals at risk of developing obesity-related diabetes. It also evaluates if the amount of fat in the pancreas can predict the residual functional capacity of the pancreas (insulin secretion).


Eligibility Criteria:
Inclusion Criteria:

* adults without prior history of pancreatic disease (other than diabetes)

Exclusion Criteria:

* use of unapproved medications
* contraindications to the MRI procedure
* contraindications to frequent blood draws
* pregnancy
* use of more than 2 alcoholic drinks/day
Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: iMACS Study

The aim of this study is to develop and follow a cohort of human immunodeficiency virus (HIV)-infected adults who are starting HIV drugs at health facilities in Kenya. Blood and urine samples will be collected from all participants in order to establish a sample bank of samples in order to further the understanding of the levels of inﬂammatory biomarkers and coagulation biomarkers in African patients and the effect of taking HIV drugs on these biomarkers. This study will enroll and follow 685 men and women who are starting HIV drugs and collect blood and urine specimens from them at 4 study visits. These samples will be frozen and stored for future testing related to inﬂammatory and coagulation biomarkers.

Biomarkers have been investigated as predictors of HIV disease progression, i.e. development of acquired immunodeficiency syndrome (AIDS) deﬁning diagnoses or death. There are limited data on the levels of these biomarkers among HIV-infected individuals in sub Saharan Africa and on the effect of antiretroviral therapy (ART) initiation on these levels. In addition, further work is needed to examine the association between such markers and various complications associated with HIV as well as mortality in sub Saharan Africa. The overall aim of this study is to develop a cohort of HIV-infected adults who are initiating ART at health facilities in Kenya and to establish a sample bank of plasma and urine samples in order to further the understanding of the levels of inﬂammatory biomarkers (IBM) and coagulation biomarkers (CBM) in African patients and the effect of ART initiation on these biomarkers. The study objectives are as follows:

* To recruit, establish and follow a cohort of HIV-infected individuals who are eligible for initiation of ART through 12 months
* To obtain blood and urine samples on all cohort participants at baseline, months 2, 6, and 12 for future HIV and related research
* To describe the demographic and disease characteristics of cohort participants and associations with various biomarkers

Eligibility Criteria:
Inclusion Criteria:

* Men and women at least 18 years of age
* Known to be HIV positive
* ART-naïve (with exception of prior exposure to single dose nevirapine in women)
* Documented ART eligibility based on CD4+ cell count and/or WHO staging
* Willing to provide locator information and to adhere to study procedures.
* No intention of permanently moving away from area for coming 12 months

Exclusion Criteria:

* Individuals who do not meet the inclusion criteria outlined above
* Women who are currently pregnant
* Any condition which in the opinion of the investigators would interfere with participation in the study
Impact of Fluid Resuscitation Therapy on Pulmonary Edema as Measured by Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome (ARDS)

The need for fluid resuscitation (FR) in ICU patients with acute respiratory distress syndrome (ARDS) is common. Indeed, relative or absolute hypovolemia is a common phenomenon that the intensivist must recognize early and treat promptly. Fluid challenge may have adverse side effects associated with fluid administration. The diffusion within the interstitial space may favor edema formation and cause cardiac dysfunction by volume overload. Edema formation is global and may specifically alter pulmonary alveolar epithelial integrity, leading to enhanced alveolar edema and impaired gas exchange.

Currently, two types of fluids are frequently used, crystalloids and colloids. Among colloids and compared to crystalloids, albumin has the theoretical advantage of causing greater volume expansion.

We hypothesized that a fluid resuscitation therapy with albumin generates less pulmonary edema than a fluid resuscitation therapy with crystalloids.

The aim of our study is to compare alveolar fluid clearance, as a marker of alveolar edema fluid resorption, in 2 groups of patients: those treated with albumin and those treated with crystalloid.

The main objective of our prospective double blind, randomized, controlled trial is to compare the rate of alveolar fluid clearance, a marker of alveolar edema fluid resorption, in 2 groups of patients with ARDS and suffering from hypovolemia: those treated with albumin and those treated with crystalloid (fluid challenge of 7 mL/kg over 15 minutes, that can be repeated 3 times if hypovolemia persists).

The evolution of respiratory and hemodynamic parameters, as measured by transpulmonary thermodilution (extra-vascular lung water, pulmonary vascular permeability index, cardiac output, global enddiastolic volume), plasma osmolality, plasma oncotic pressure and plasma levels of brain natriuretic peptid (BNP) will be studied one hour and 3 hours after after fluid resuscitation in the two groups. In order to evaluate alveolar epithelial dysfunction in patients receiving either albumin or crystalloid, plasma and alveolar levels of sRAGE (the soluble form of the receptor for advanced glycation endproducts) will be measured by ELISA. Lung aeration and fluid-induced derecruitment will be evaluated with an electrical impedance tomograph (PulmoVista®500, Dräger).

Eligibility Criteria:
Inclusion Criteria:

* ICU patients under mechanical ventilation
* Patients within the first 24 hours after onset of moderate or severe ARDS, as defined by the Berlin definition (JAMA. 2012;307(23):2526-2533)
* Hypovolemia requiring fluid resuscitation therapy

Exclusion Criteria:

* Pregnancy
* Age under 18
* Refusal of the protocol
* Contraindications for the use of Voluven© or Ringer Lactate©
* Contraindications for femoral artery catheterization or subclavian venous catheterization
A Study to Evaluate Effectiveness and Safety of Hyaluronic Acid (HA) Fillers

The purpose of the study is to investigate the degree of improvement in appearance after treatment with different hyaluronic acid (HA) fillers. Product selection is based on Investigator assessment of participant tissue coverage and main treatment goal (volumizing, lifting or contouring).


Eligibility Criteria:
Inclusion Criteria:

* Male/Female 25 to 55 years old that needs lifting, contouring or volumization of the midface
* Signed and dated informed consent

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel and lidocain
* Previous use of any permanent or semi-permanent facial tissue augmentation therapy or contouring with, lifting threads, permanent implants, or autologous fat in the treatment area
* Previous use of any HA or collagen based facial tissue augmentation therapy in the facial area, any previous use of neurotoxin or any previous facial surgery
* Any medical condition that in the opinion of the Investigator would make the participant unsuitable for inclusion