Kornimate/medical-research-clean huggingface dataset:
study evaluating the efficacy and safety of prt-2761 for the treatment of acute and chronic allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: to evaluate the efficacy and safety of two concentrations of prt-2761 as a topical ophthalmic solution for the treatment of the signs and symptoms of acute and chronic allergic conjunctivitis.


Eligibility criteria:
inclusion criteria: * be at least 18 years old * be willing and able to avoid all disallowed medications and contact lenses * must have a pregnancy test if of childbearing potential * must be able to read an eye chart from 10 feet away exclusion criteria: * must not have any allergies to the study medications * must not have any ocular or non ocular condition that investigator feels will interfere with study parameters * must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial
comparative effects of sustained stretch and mobilization with movement in patient with tennis elbow

Conditions: Tennis Elbow; Lateral Epicondylitis

Summary: tennis elbow, clinically known as lateral epicondylitis, is a prevalent musculoskeletal issue marked by pain and tenderness on the outer part of the elbow. it primarily affects the extensor tendon at the lateral epicondyle and is commonly linked to repetitive arm movements and overuse. various treatment options are available for this condition, with two notable methods being sustained stretching and mobilization with movement (mwm). sustained stretching involves holding the affected muscles and tendons in an extended position for a prolonged time to ease muscle tightness and enhance flexibility. conversely, mwm integrates specific joint movements with the active involvement of the patient to improve joint mobility and reduce pain. muscle strength plays a crucial role in the overall function of the upper limb, and enhancing this can positively affect daily activities. furthermore, functional disability indicates how tennis elbow impacts a person's capacity to carry out everyday tasks.

this randomized clinical trial will be conducted at riphah rehab center over duration of eight months. the sample size will consist of 58 participants. participants which meet the inclusion criteria will be taken through non-probability convenience sampling technique. 29 participants will be assigned to group a 29 to group b. data will be collected using various assessment tools, including nprs, ulfi, universal goniometer, hand held dynamometer. pre-intervention assessments will be conducted for groups. data analysis will be performed by using spss 26 software.

Eligibility criteria:
inclusion criteria: * both males and females are affected. diagnosed with tennis elbow, characterized by pain and weakness on the outer side of the elbow. * the pain has persisted for at least 4 to 6 months. * individuals experience difficulty gripping and lifting objects due to elbow pain. * positive results were observed in both the mills and cozen tests. exclusion criteria: * presence of nerve injuries or neuropathies in the arm or hand. * no history of recent trauma or fracture to the elbow. * no neurological conditions affecting the arm or hand * acute inflammation or signs of infection in the elbow joint. * presence of cervical radiculopathy, thoracic outlet syndrome any systemic diseases

Keywords: lateral epicondylitis tennis elbow sustained stretch mobilization with movement muscle strength
gelsectan® and covert hepatic encephalopathy

Conditions: Covert Hepatic Encephalopathy

Summary: randomized crossover pilot clinical trial in which 10 cirrhotic patients with covert hepatic encephalopathy (che) will be assigned to take gelsectan® (tid) or placebo for 30 days. after a washout period of 15 days, the treatment branches will be interchanged. the objective of the trial is to obtain pilot variances to design a phase ii trial, in which the efficacy of the treatment will be tested. as an exploratory objective, the efficacy of the product in the treatment of covert hepatic encephalopathy will be analyzed. main endpoint improvement in che after 30 days of treatment with gelsectan®, measured by the psychometric hepatic encephalopathy score (phes)


Eligibility criteria:
inclusion criteria: 1. age between 18 and 85 years. 2. liver cirrhosis defined by a previous liver biopsy or by clinical data. 3. presence of minimal hepatic encephalopathy (mhe) defined by two psychometric methods (phes and / or s-ant and / or sloop-test). 4. adequately informed patients who grant their written consent to participate in the study. exclusion criteria: 1. alternative neurological diagnosis. 2. hepatic encephalopathy stage ≥2 using the adapted west-haven scale. 3. terminal disease. at the discretion of the doctor, where the patient is in an irreversible situation, in which hepatic encephalopathy is a final manifestation. 4. presence of acute-on-chronic liver failure defined by the presence of decompensated liver cirrhosis with severe organ or multi-organ failure. 5. meld score greater than 25 at the time of inclusion. 6. hospitalization for any reason. 7. neurological or psychiatric comorbidity that makes the evaluation of hepatic encephalopathy difficult. this includes patients with mental illnesses (dementia, cerebrovascular disease with sequelae, parkinson's disease, schizophrenia). 8. active digestive bleeding. before inclusion, there must have been a 48-hour period without signs of bleeding. 9. patients with hypersensitivity or allergy to any of the components of gelsectan® (grape, pea). 10. clinical situations in which the administration of oral feeding is contraindicated. 11. active oncological processes, including hepatocarcinoma. 12. active infection of any origin. 13. acute renal failure (aki). defined by the current diagnostic criteria of the kdigo group (kidney disease improving global outcomes). 14. dehydration diagnosed by physical examination of the patient. 15. severe hyponatremia. defined by plasma sodium \<130 meq / dl. 16. concomitant use of sedative drugs, such as benzodiazepines, morphic or derivatives (methadone, tramadol ...) 17. active drug and/or alcohol use. in each case of clinical suspicion of drug use, an analysis of toxins in urine will be carried out, which includes cocaine, cannabis, opiates. all patients with confirmed alcohol consumption greater than 3 ubd in men or 2 ubd in women will be excluded. 18. consumption of drugs currently indicated for the treatment of he: lactulose, lactitol and antibiotics. 19. participation in another clinical trial

Keywords: covert hepatic encephalopathy cirrhosis
a study being conducted at multiple locations to compare safety and efficacy of three different regimens; (1) high-dose lenalidomide; (2) lenalidomide + azacitidine; or (3) azacitidine in subjects ≥ 65 years with newly-diagnosed acute myeloid leukemia

Conditions: Acute Myeloid Leukemia; Acute Myelogenous Leukemia

Summary: the study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed acute myeloid leukemia (aml).

on september 11, 2013, randomization into the continuous 50 mg lenalidomide only arm was temporarily suspended based on review of the data from the first 13 participants and a high rate of discontinuation (11/13 participants). the data monitoring committee assessed the study data on september 20, 2013 and reported no safety concerns. the high rate of early discontinuation is inconsistent with the treatment duration required for testing the study primary endpoint of survival at one year. consequently, celgene has decided not to reopen the lenalidomide only arm.

Eligibility criteria:
inclusion criteria: * newly diagnosed acute myeloid leukemia (aml), aml with antecedent hematologic disorder or therapy-related aml * male or female subjects aged ≥ 65 * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 * white blood cell (wbc) count ≤ 10 x 10⁹/l at screening exclusion criteria: * previous treatment with azacitidine, decitabine, cytarabine or lenalidomide * previous cytotoxic or biologic treatment of any kind for aml or prior use of targeted therapy agents. * suspected or proven acute promyelocytic leukemia * prior bone marrow or stem cell transplantation * candidate for allogeneic bone marrow or stem cell transplantation * aml antecedent hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms * presence of malignant disease within the previous 12 months with exceptions

Keywords: aml elderly acute myelogenous leukemia vidaza azacitidine elderly aml revlimid lenalidomide
treatment of anxiety disorders with trigeminal nerve stimulation

Conditions: Panic Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder

Summary: primary objectives: the primary objective is to ascertain if trigeminal nerve stimulation is an effective treatment with high tolerability for patients with panic disorder, generalized anxiety disorder and social anxiety disorder.


Eligibility criteria:
inclusion criteria: * meet dsm5 criteria for panic disorder, social anxiety disorder or generalized anxiety disorder. exclusion criteria: * subjects undergoing cognitive behavioural therapy. * subjects undergoing pharmacological treatment for an anxiety disorder. * subjects undergoing pharmacological treatment with antidepressants or benzodiazepines. * subjects with moderate to severe major depressive disorder based on the phq-9 test (score of 15 or above) at baseline. * moderate to high current suicidality or "suicide likely in near future" or current suicidal behavior disorder. * concurrent diagnosis of ocd, ptsd, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities or dementia. * subjects diagnosed with neurological diseases including trigeminal neuralgia. * pregnant or breastfeeding women. * subjects who are experiencing seizures. * individuals with implanted vns or other electrical devices. * subjects who are already undergoing transcutaneous electrical nerve stimulation. * consumption of cannabis, any cannabis by-products, illicit drugs, or alcohol above 3 drinks per week. * consumption of natural health products that may affect anxiety or depression symptoms.
enhancing resilience in senior community residents

Conditions: Quality of Life; Stress, Psychological

Summary: this randomized waitlist-controlled trial tests the efficacy of the stress management and resiliency training relaxation response resiliency program (smart-3rp), a mind-body intervention, to enhance resilience and flourishing among residents in continuing care retirement communities. the investigators hypothesize that participants in the smart-3rp group will report greater increases in resilience and flourishing relative to participants in the control group.

this randomized control trial tests the efficacy of the stress management and resiliency training relaxation response resiliency program (smart-3rp) to improve resilience and flourishing among older adults residing in continuing care retirement communities relative to a wait-list control group. at enrollment, participants will be randomly assigned to the intervention group or the control group using computer generated 1:1 blocked randomization stratified by community site. the intervention group will receive the smart-3rp program immediately upon enrollment; the wait-list control group will be invited to receive the smart-3rp program after the final survey time point. an estimate of 360 participants will be recruited from up to nine geographically diverse erickson senior living communities.

Eligibility criteria:
inclusion criteria: * resident of an erickson senior living community * currently residing in an erickson senior living apartment home * sufficient english language skills to participate in study procedures exclusion criteria: * unable or unwilling to provide informed consent * unable or unwilling to participate in in-person group sessions

Keywords: resiliency flourishing coping skills stress reduction healthy aging
customized acoustic stimulation for long term medical benefit for the relief of tinnitus and hyperacusis

Conditions: Tinnitus; Hyperacusis

Summary: neuromonics tinnitus treatment calm study is a multi site study of 100 adult subjects with clinically significant disturbing tinnitus to evaluate outcome measures using the fda cleared neuromonics treatment after 6, 12, 24 and 36 months. patients must be meet certain inclusion criteria and they are also required to pay for the all costs of the treatment. subjects will be provided a modest participation fee at 6, 12, 24 and 36 months upon completion of patient questionnaires (subjects must have access to a computer and internet in order to complete on line questionnaires).


Eligibility criteria:
inclusion criteria: * 18 years of age, * trq of at least 17 or above, * able to pay for the treatment, * not using any other treatment for tinnitus, * access to computer and internet, * compliant patient exclusion criteria: * hearing pta \> 50 db, score on hads of greater than 11 on the anxiety and depression scale, * not willing to follow the protocol

Keywords: tinnitus ringing in the ears buzzing static hyperacusis loudness discomfort clinically significant discomfort
long-term outcome following the treatment of pediatric scoliosis

Conditions: Adolescent Idiopathic Scoliosis

Summary: evaluate the long-term outcomes following operative and nonoperative treatment of childhood scoliosis.

the investigators hypothesize that sagittal alignment and thoracic volumes will predict successful treatment outcomes as measured by improved pulmonary function and health-related quality of life in adolescent idiopathic scoliosis patients at a minimum 20-year follow-up. significant focus has been placed on the coronal plane in order to determine treatment indications for scoliosis, but with new understanding about the important of sagittal balance and pulmonary function, the treatment indications should be broadened. thus, the investigators propose the following study to explore parameters associated with a durable and acceptable outcome following scoliosis treatment, minimizing the need for further surgery and to optimizing quality of life and pulmonary health. beyond the standard radiographs and scoliosis research society (srs) scores, this study undertakes a comprehensive assessment of health-related quality of life, chest asymmetry and body satisfaction scoring, sagittal plane parameters, and 3d modeling of the childhood and current spinothoracic deformity. thus, the investigators research team is uniquely poised to determine broader treatment indications for scoliosis. the overarching goal of this research effort is to determine new parameters based on thoracic volume and sagittal plane alignment in addition to coronal deformity in order to determine the appropriate treatment threshold for surgical intervention in children with adolescent idiopathic scoliosis.

Eligibility criteria:
inclusion criteria: * diagnosis of adolescent idiopathic scoliosis made before age 18 * diagnosis of adolescent idiopathic scoliosis prior to 1994 * treatment with bracing, observation, or surgery prior to age 18 and 1994 * adequate radiographs/medical records available from time of diagnosis exclusion criteria: * neuromuscular scoliosis * syrinx * inadequate radiographs/medical records available from time of diagnosis

Keywords: scoliosis long-term outcomes sagittal plane quality of life curve progression pulmonary function
evaluation of use of plastic bags to prevent neonatal hypothermia-part iii

Conditions: Hypothermia

Summary: the overall hypothesis is that plastic bags used in combination with who thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine who thermoregulation care alone. part iii is for preterm/low birth weight infants with or without a plastic torso wrap during the first hour after birth to assist with temperature regulation during placement in an incubator.

incubators in the developing world often lack humidifiers. the resting dry heat increases evaporative heat loss, the most prominent form of heat loss in premature infants due to their increased body surface area and immature stratum corneum. by potentially increasing humidity around the infants and decreasing evaporative heat losses, plastic bags may improve incubator warming. this study will compare the incidence of hypothermia in infants placed in an incubator for at least one hour randomized to receive standard incubator protocol (control group) or standard incubator protocol plus a plastic bag covering their torsos and lower extremities (intervention group). the axillary temperature of each infant will be taken before placement into the incubator and one hour later when the bag will be removed. blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage, incubator temperature, and humidity, and length of time in an incubator will be recorded throughout the hospitalization for all infants. with an estimated baseline hypothermia rate of 90% and a hypothesized 20% absolute risk reduction (22% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.

Eligibility criteria:
inclusion criteria: * infant admitted to the nicu * current weight between 1,000 and 2,500g * being placed in an incubator exclusion criteria: * abdominal wall defect or myelomeningocele * major congenital anomalies * blistering skin disorder

Keywords: hypothermia low birth weight newborn incubator plastic bag
proactive palliative care for patients with ventricular assist devices (vad) and their families

Conditions: Heart Failure; End-stage Disease

Summary: the primary aim of the study is to provide "proof of concept" to demonstrate that patients with ventricular assist devices (vads) and caregivers are willing to be enrolled in a randomized trial of palliative care and that such a study is feasible. secondary aims include demonstrating improvement in symptoms (physical and psychological) for intervention patients and their caregivers as compared to control patients and caregivers. the investigators will also examine differences in utilization of healthcare services, mortality, and completion of advance directives between intervention and control patients.

a ventricular assist device is an implanted mechanical device which augments the pumping function of the heart's ventricles. the number of patients with vads is expected to increase in an exponential manner in the years to come as device technology improves and continues to show a survival benefit. the investigators propose a randomized controlled trial of a proactive palliative care intervention for patients with vads and their caregivers. patients randomized to palliative care will receive ongoing counseling and symptom assessment as well as clarification and documentation of goals of care, starting before implantation and continuing throughout the course of the study. the intervention is delivered primarily in the outpatient setting by a palliative care nurse practitioner. intervention patients will also be followed by the inpatient palliative care consultation service when hospitalized for their initial vad implantation and during any subsequent hospitalizations as needed. control patients will receive usual care as provided by the vad clinical team. data collection will be performed by a research assistant at mount sinai (blinded to randomization) who conducts baseline assessments in person, and then follow-up assessments over the phone. the primary aim of the study is to provide "proof of concept" to demonstrate that patients and caregivers are willing to be enrolled in a randomized trial of palliative care and that such a study is feasible. secondary aims include demonstrating improvement in symptoms (physical and psychological) for intervention patients and their caregivers as compared to control patients and caregivers.

Eligibility criteria:
inclusion criteria: * age \>21 years * fluent in english * have a caregiver/family member who is willing to be enrolled and who is also fluent in english * consistent and reliable access to a phone exclusion criteria: * non english-speaking

Keywords: heart failure ventricular assist device palliative care
tools for the objective clinical assessment of pediatric spinal deformity

Conditions: Thoracic Insufficiency Syndrome; TIS

Summary: this project seeks to develop a standardized technique for simultaneous capturing bi-planar images of patients against a standard background with a grid that can be used later for the quantitative determination of global balance and thoracic symmetry. we hypothesize that patients who are successfully managed with surgery will demonstrate an improvement in global balance and thoracic symmetry that can be accurately measured. this measurement station will be specifically developed to provide a standardized, reproducible means to compare clinical assessments of surgical and non-surgical outcomes, and establish normative data for comparison. this standardized tool can be established at multiple centers for use in multicenter trials.


Eligibility criteria:
inclusion criteria: * male and female participants from 1- skeletal maturity exclusion criteria: * no specific disease related exclusion criteria
study assessing the efficacy and safety of intravitreal injections of de-122 in combination with lucentis® compared to lucentis® monotherapy in wet age-related macular degeneration subjects

Conditions: Age-Related Macular Degeneration

Summary: to assess the safety and efficacy of repeated intravitreal injections of de-122 (low dose and high dose) given in combination with lucentis® in subjects with wet age-related macular degeneration (amd) compared with lucentis® alone.


Eligibility criteria:
inclusion criteria: * provide signed written informed consent * diagnosis of active choroidal neovascularization secondary to wet amd * bcva of 65 to 25 etdrs letters (20/50 to 20/320) in the study eye * bcva of 25 etdrs letters (20/320) or better in the fellow eye exclusion criteria: \[ocular\] * use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of amd within a specified timeframe prior to visit 1 and throughout the study * uncontrolled or advanced glaucoma, chronic hypotony or vitrectomy in the study eye * evidence of any other ocular disease other than exudative age-related macular degeneration in the study eye that may confound the outcome of the study * need for ocular surgery in the study eye during the course of the study * presence or history of certain ocular or periocular pathology or conditions that could limit the ability to perform examinations \[non-ocular\] * allergy or hypersensitivity to study drug product, fluorescein dye or other study related procedures and medications * current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for the study * participation in other investigational drug or device clinical trials within 30 days prior to randomization or planning to participate in other investigational drug or device clinical trials for the duration of the study * females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions and men who do not agree to practice an acceptable method of contraception throughout the course of the study * unable to comply with study procedures or follow-up visits