Kornimate/medical-research-clean huggingface dataset:
clinical trial tobacco marijuana

Conditions: Cannabis Use Disorder; Tobacco Use Disorder

Summary: approximately 50% of persons seeking treatment for cannabis-use disorders (cuds) regularly smoke tobacco. combining tobacco with cannabis has become a common method of smoking cannabis. similarities of use, and using together, can make quitting difficult. stopping tobacco simultaneously with cannabis may be beneficial. little scientific information currently addresses how to best target tobacco smoking during treatment for cuds. our long-term goal is to develop an effective protocol for intervening in tobacco smoking without changing cannabis outcomes. this protocol reflects the planned stage 1, proof-of-concept study that will compare a combined cannabis and tobacco intervention to one that targets cud only. hypotheses assert that the intervention (1) will be accepted by the majority of eligible participants (2) will result in more tobacco quit attempts and rates than the cud-only treatment; and (3) will not adversely affect cannabis outcomes. last, the project will evaluate the potential of specific moderators of outcomes to predict outcomes and inform subsequent treatment development efforts. if the hypotheses were confirmed, dissemination of this protocol would reduce adverse psychosocial and health consequences of tobacco or cannabis dependence. findings will inform future development of prevention and intervention strategies.


Eligibility criteria:
inclusion criteria: 1. individuals must be 18 years or older 2. individuals must meet criteria for the current diagnostic and statistical manual -iv diagnosis of cannabis abuse or dependence, report use of cannabis on at least 45 of the previous 90 days, and report regular use of tobacco cigarettes or report that their primary administration of cannabis is via blunts or spliffs 3. individual must indicate that they have at least some interest in quitting tobacco in the next 6 months (rating of 2 or more on a 5-point interest scale) exclusion criteria: 1. current dependence on alcohol or any drug other than tobacco and cannabis 2. use of non-tobacco nicotine 3. current participation in structured treatment for substance abuse 4. severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder) 5. report of a condition that requires seeing a physician before using nrt (e.g., pregnancy or recent heart attack); note: if a participant's physician approves taking nrt, we will consider enrolling them 6. legal status that would interfere with participation 7. living with someone currently enrolled in the project 8. not being fluent in english 9. not living within 45 miles of the research site

Keywords: cannabis use disorder tobacco use treatment
safety and efficacy of angiotensin (1-7) in persons with moderate to severe traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the goal of this clinical trial is to test the safety of the drug angiotensin (1-7) and learn whether it works well as a treatment in people who have suffered a moderate to severe traumatic brain injury (tbi). the main questions this trial aims to answer are: * is angiotensin (1-7) safe? * does angiotensin (1-7) improve mental functioning and reduce physical signs of brain damage in people who have suffered a moderate to severe tbi? participants will: * complete 21 days of study treatment consisting of a once-daily injection. * provide blood samples. * undergo two magnetic resonance imaging (mri) scans of the brain. * complete specific tasks and questionnaires that allow researchers to evaluate the participant's brain and psychological functioning. researchers will compare three groups: two groups that receive different doses of angiotensin (1-7) and one group that receives a look-alike treatment with no active drug. this will allow researchers to see if the drug has any negative effects and whether it improves mental functioning and physical signs of brain damage after a tbi.


Eligibility criteria:
inclusion criteria: * participant or representative willing to provide informed consent. * age 18 years or older at time of enrollment. * traumatically induced head injury resulting from insult to head from an external force. * clinical diagnosis of acute intracranial lesion based on neuroradiologist report. ct scan and report must be available. * moderate or severe traumatic brain injury (tbi) defined as glasgow coma scale (gcs) score on trauma presentation of 12 or less. in general: moderate tbi will be defined as loss of consciousness between 30 minutes and 24 hours and gcs between 9 and 12. severe tbi will be defined as loss of consciousness \> 24 hours and gcs ≤ 9. * enrollment within 48 hours of tbi. exclusion criteria: * time of injury cannot be determined. * neurosurgery within the last 30 days. * history of neurodegenerative disease or disorder including dementia, parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors that would impact cognitive testing. * contraindication to having an mri. * pregnant or lactating female. * female of childbearing potential or sexually active male who is not willing to use an acceptable method of birth control for the treatment period and 7 days after the last dose of the study drug. * participation in another clinical study involving investigational product within 30 days prior to study enrollment. * if in the opinion of the investigator, candidate is unsuitable for participation in the study.

Keywords: renin angiotensin system cognition
biomarkers for the detection of lymphatic insufficiency

Conditions: Lymphedema

Summary: acquired lymphedema is a disease that causes chronic swelling of the limb(s). it is frequently under-recognized or misdiagnosed. this study is designed to lead to the development of an accurate, noninvasive, blood test to allow testing for lymphedema. this approach is particularly useful to investigate relative responses to treatment interventions.

the validation of a sensitive and specific biomarker assay for human acquired lymphatic vascular insufficiency would represent a highly significant development for the patient community. accurate bioassay for the presence of lymphatic vascular insufficiency should help to pave the road for future human clinical trials of experimental drugs and therapies designed to treat human lymphatic diseases. molecular profiling will be performed in human tissues (skin) obtained by biopsy. the insights gained from these initial analyses will determine the targets for assay in human body fluids (blood).

Eligibility criteria:
inclusion criteria for lymphedema participants: * clinical diagnosis of lymphedema of at least 6 months' duration control participants: * no evidence of lymphedema exclusion criteria for lymphedema participants: * active cancer * infection * bleeding tendency * active coronary artery disease * congestive heart failure * history of stroke or transient ischemic attack (tia) * uncontrolled hypertension * renal insufficiency (serum creatinine \> 1.1) * active inflammatory or autoimmune disease (other than lymphedema) for control participants: * lymph node dissection * radiation therapy * active inflammatory disease
study evaluating safety of etanercept in treatment of patients with moderate to severe psoriasiswith etanercept

Conditions: Psoriasis

Summary: evaluate (i) safety of etanercept in patients with moderate to severe psoriasis in spain; (ii) the incidence of adverse events reported in these patients, and (iii) the role that age and concomitant therapy might play in the development of adverse reactions.


Eligibility criteria:
inclusion criteria: 1. informed consent signed by patients prior to study entry 2. 18 years of age or older at screening visit 3. patients with moderate to severe psoriasis 4. patients who have failed conventional systemic treatment 5. patients who have a contraindication to conventional systemic therapy 6. patients who are intolerant to conventional systemic therapy 7. a negative serum pregnancy test at screening in women of childbearing potential 8. able to self-inject study drug or have a designee who can do so 9. in the opinion of the investigator, the patient will be able to comply with the requirements of the protocol
open-label study of intramuscular olanzapine depot in patients with schizophrenia or schizoaffective disorder

Conditions: Schizophrenic Disorders; Schizoaffective Disorder

Summary: this is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot. key objectives of the study are to: * determine how well intramuscular (im) olanzapine depot works during long-term treatment, * evaluate the safety and tolerability of im olanzapine depot during long-term treatment, * determine the blood levels of im olanzapine depot in patients during long-term treatment


Eligibility criteria:
inclusion criteria: * patients must have schizophrenia * female patients of childbearing potential must be using a medically accepted means of contraception * patients must have completed (within 10 days) another im olanzapine depot study if permitted by that study's protocol. exclusion criteria: * patients must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry * female patients must not be pregnant or breast-feeding * patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia or schizoaffective disorder * patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days
stevie: a study of vismodegib in patients with locally advanced or metastatic basal cell carcinoma

Conditions: Basal Cell Carcinoma

Summary: this single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (gdc-0449) in patients with locally advanced or metastatic basal cell carcinoma. patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * metastatic or locally advanced basal cell carcinoma considered inoperable or that surgery is contraindicated and radiotherapy is contraindicated or inappropriate * eastern cooperative oncology group (ecog) performance status 0-2 exclusion criteria: * concurrent anti-tumor therapy * completion of the most recent anti-tumor therapy less than 21 days prior to the initiation of treatment * uncontrolled medical illness
study of the efficacy and safety of ruxolitinib to treat covid-19 pneumonia

Conditions: COVID-19; Pneumonia

Summary: the purpose of this study is to determine the safety and efficacy of the drug ruxolitinib in people diagnosed with covid-19 pneumonia by determining the number of people whose conditions worsen (requiring machines to help with breathing or needing supplemental oxygen) while receiving the drug. this is a sub-study of the u-deploy study: uhn umbrella trial defining coordinated approach to pandemic trials of covid-19 and data harmonization to accelerate discovery. u-deploy helps to facilitate timely conduct of studies across the university health network and other centers.

multifocal interstitial pneumonia is the most common cause of deterioration in people with covid-19. this is attributed to a severe reaction where releases too many cytokines (proteins that play an important role in immune responses) which rush into the lungs resulting in lung inflammation and fluid buildup. this can lead to damage to the lungs and leading to breathing problems. ruxolitinib when given early in the disease, may prevent the overproduction of cytokines which, in turn, may prevent lung damage.

Eligibility criteria:
inclusion criteria: * covid-19 infection diagnosed by nasopharyngeal sample * need for supplemental oxygen to maintain oxygen saturation \> 93% * 12 years of age or older exclusion criteria: * neutrophils \< 1 x 10\^9/l * platelets \< 50 x 10\^9/l * serum total bilirubin \>2.0 x upper limit of normal (uln) * aspartate aminotransferase (ast), or alanine aminotransferase (alt) \> 5x uln * creatinine clearance (crcl) \< 15 ml/minute * pregnant women * known hbv or hiv infection * signs and symptoms of varicella zoster virus (vzv) infection * patients requiring invasive mechanical ventilation. patients requiring non-invasive mechanical ventilation (e.g., bipap) are eligible. * patients who require supplemental oxygen support prior to covid-19 infection. * patients who are on ruxolitinib or similiar drugs.
advance care planning in cognitive disorders clinic

Conditions: Advance Care Planning

Summary: advance care planning among patients with cognitive disorders poses unique challenges to clinicians. to improve planning in patients with alzheimer's disease and other dementias, the researchers suggest a routine, standardized approach to these conversations. the main outcome measure is the rate of entry of advance directive completion in the patient's electronic health record (ehr). a control group of similar patients from another provider specializing in cognitive disorders will be used to tease out confounding variable effects.


Eligibility criteria:
inclusion criteria: * patients having mild cognitive impairment (mci) or very mild to mild dementia (cdr 0.5-1). exclusion criteria: * patients with moderate to severe dementia (cdr 2-3).

Keywords: alzheimer's disease dementia
study of sentinel lymph node assessment following previous surgical biopsy for early breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to assess the detection rate and false negative rate of sentinel lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis.


Eligibility criteria:
inclusion criteria: * age \> 18 years * previous conservative surgical biopsy * secondary pathological diagnosis of infiltrative cancer * no clinically involved axillary node (n0) * no previous neoadjuvant treatment * performance status european cancer conference (ecco) grade ≤ 1 * patient's written informed consent to participate in the study according to french law * surgeon must have performed its learning curve exclusion criteria: * lack of infiltrative breast carcinoma (in situ) pt4d \> n0 * breast cancer relapse * pregnancy * known patent blue allergy * indication for radical or partial mastectomy * patient unable to understand the trial

Keywords: breast infiltrative cancer
the use of 3d printing in orbital fractures

Conditions: Orbital Fractures

Summary: the study is a prospective randomized longitudinal clinical study to compare pre-adapted patient-specific orbital implants utilizing an office-based 3-d printer versus standard non-adapted orbital implants (the latter being the traditional approach and current standard of care).

orbital fracture, which accounts for 10-25% of facial fractures, is one of the most difficult facial fractures to treat. the complex bone anatomy and the proximity of adjacent vital structures make reconstruction of these fractures challenging. inadequate orbital fracture reconstruction leads to cosmetic and functional complications. cosmetic complications include enophthalmos, which is defined as posterior displacement of the eyeball within the orbit due to changes in the volume of the orbit (bone) relative to its contents (the eyeball and orbital fat). functional complications include diplopia, defined as a type of vision disorder in which two images are seen of a single object. this is a prospective randomized clinical study with longitudinal follow-up. the study duration is 2 years, and it will be conducted at grady memorial hospital (gmh). the study targets low-income, urban adults suffering blunt facial trauma who are diagnosed with unilateral orbital fracture. the purpose of this study is to compare pre-adapted patient-specific orbital implants utilizing an office-based 3-d printer versus standard non-adapted orbital implants. main aims of the study are to 1) preoperatively generate a patient-specific model to pre-adapt the titanium mesh for use in unilateral orbital fractures; 2) accurately restore the orbital volume to pre-injury levels; 3) prevent postoperative complications including enophthalmos and diplopia; and 4) decrease the operative time, therefore decreasing overall cost and increasing value.

Eligibility criteria:
inclusion criteria: * agreed to be enrolled in the study. * indications for surgical repair of orbital floor and/ wall fractures are dependent on several factors: * correction or prevention of cosmetic deformity ( enophthalmos or inferior dystopia; disruption of greater than 50% of the orbital floor is likely to cause cosmetically apparent enophthalmos. * correction of unresolved diplopia (7 to 11 days) in the sitting of soft tissue prolapse with a positive forced duction test. * immediate correction of diplopia in the sitting inferior rectus muscle incarceration and a positive forced duction test. * immediate correction in a symptomatic patient with orbital floor ( trapdoor) fracture that has elicited the oculocardiac reflex. * at least 18 years of age. * unilateral orbital floor fracture. * no history of orbital trauma. * healthy contralateral orbit. * underwent orbital reconstruction. * admitted to gmh. * returned for the 6-week follow-up. exclusion criteria: * refuse study enrollment. * are younger than 18 years. * pregnant women. * prisoner * unable to obtain consent (cognitively impaired) * are admitted to hospitals other than grady memorial hospital.

Keywords: 3d printer orbital implants
observational study to evaluate safety of levemir® in type 1 and type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this observational study is to evaluate the incidence of adverse events while using levemir® under normal clinical practice conditions.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes mellitus exclusion criteria: * subjects who are unlikely to comply with the protocol * subjects who are currently being treated with levemir® * subjects who previously were enrolled into the study * subjects with hypersensitivity to levemir® or any of its excipients
magnetic resonance imaging evaluation of lateral ankle instability

Conditions: Ankle Injuries

Summary: lateral ankle instability may be acute or chronic. acute instability usually occurs due to extreme rear foot supination with planter-flexion trauma leads to injury of lateral collateral ligament complex especially the anterior talofibular ligament. most ankle ligamentous injuries are treated conservatively. however, 20% to 40% of patients complain of chronic instability and persistent discomfort. structural instability, loss of proprioceptive capabilities, and the weakness of peroneal muscles seem to induce chronic instability


Eligibility criteria:
inclusion criteria: - patients with any sex, age, complaining of chronic lateral ankle pain. exclusion criteria: 1. tumors at ankle region. 2. postoperative status around the ankle. 3. rheumatoid arthritis. 4. comminuted fracture at the ankle. 5. congenital anomalies of the ankle.
epidemiological study of neonatal acute respiratory distress syndrome (ards)

Conditions: Neonatal Acute Respiratory Distress Syndrome(ARDS)

Summary: neonatal acute respiratory distress syndrome(ards) is a rare but often severe respiratory disorder. the incidence remains unclear and mortality is about 30%-60%. it is characterized by acute, refractory hypoxemia, persistent respiratory distress and decreased lung compliance. evaluation and comparison of various clinical studies conducted were hindered by a lack of uniformity in diagnostic criteria.

in 2017, the neonatal acute respiratory distress syndrome(ards) consortium working group has proposed diagnostic criteria for neonatal ards. the study consists of a prospective, multicentre, web-based,cohort study in china in which neonates who fulfil the new criteria definition are enrolled in order to: describe the epidemiology, clinical course, and prognosis of neonates affected by neonatal ards; identify a list of risk factors for neonatal ards, as it exists for adults and older children with ards; and guide future studies.

Eligibility criteria:
inclusion criteria: * acute onset (ie, within one week) from a known or suspected clinical insult * exclusion criteria: rds, ttn, or congenital anomalies as a primary current acute respiratory condition * diffuse, bilateral, and irregular opacities or infiltrates, or complete opacification of the lungs, which are not fully explained by local effusions, atelectasis, rds, ttn, or congenital anomalies * absence of congenital heart disease explaining the oedema (this includes ductus arteriosus with pulmonary overflow if no acute pulmonary haemorrhage exists). echocardiography is needed to verify the origin of oedema. * mild ards: 4≤oi\<8;moderate ards: 8≤oi\<16;severe ards: oi≥16 exclusion criteria: * hyaline membrane disease defined as: mandatory criteria : defined as respiratory distress syndrome appearing within the first 24 hours of life, with response to surfactant and / or volume recruitment. additional criteria : lung imaging supporting the diagnosis and / or lamellar body counts \< 30,000 / mm3. * transient tachypnea of the neonate (wet lung) defined as: mandatory criteria : defined as mild ( silverman score ≤3 ) respiratory distress appearing within the first 24 hours of life and ending within the first 48 hours of life, needing only oxygen administration and / or cpap. additional criteria : lung imaging supporting the diagnosis and / or lamellar body counts \> 30,000 / mm3. - patients beyond the first month of life

Keywords: neonate acute respiratory distress syndrome prognosis risk factor clinical course
performance evaluation (sensitivity/specificity) of helioliver test for detection of hcc

Conditions: Hepatocellular Carcinoma by AJCC Stage

Summary: de-identified whole blood and serum samples are collected for the purpose of evaluating the performance (sensitivity/specificity) of the helioliver test for the detection of hepatocellular carcinoma (hcc).

the purpose of this study is to define the performance characteristics (sensitivity and specificity) of the helio liver test within a study population of subjects that have been diagnosed with liver cancer at various stages (i to iv) and for control subjects who have been confirmed to not have liver cancer by at least one imaging technique, such as ultrasound, mri or ct. control subjects will include patients who are at high-risk for liver cancer and have been recommended to undergo liver cancer surveillance, as well as patients who have non-hcc cancers to determine analytical specificity.

Eligibility criteria:
inclusion criteria: * 18 years and older (adult, older adult) exclusion criteria: * none