Kornimate/medical-research-clean huggingface dataset:
effect of psychosocial treatment by the case manager in patients after a suicide attempt

Conditions: Suicide, Attempted

Summary: the purpose of this study is to determine the case manager are effective in the treatment of suicide attempters.

compared with usual care, interventional group will (1) improve treatment attendance, (2) have less repeated suicide attempts in adults after a suicide attempts, and (3)have better patients' satisfaction with care.

Eligibility criteria:
inclusion criteria: participants recruit adults who: 1. discharge from an emergency department of a teaching hospital after attempt suicide 2. aged above 18 years old 3. agree to provide written inform consent. exclusion criteria: 1. patients were too ill to be interviewed 2. patients have immediate and severe suicide risk.

Keywords: case manager suicide attempt effectiveness
influence of vibroacoustic therapy modes on the course of coronavirus infection

Conditions: COVID-19; Acute Respiratory Failure; Vibration; Exposure

Summary: assessment of the dynamics of changes in physical, instrumental and laboratory parameters in patients with identified coronavirus infection complicated by acute respiratory failure included in the study in accordance with the inclusion criteria, and comparison of the results with the control group, study of the effect of modes when using vibroacoustic lung therapy.


Eligibility criteria:
inclusion criteria: * adults * p/f less 300 torr * covid-19 virus infection exclusion criteria: * children * acute stroke * acute coronary syndrome * dvt * implanted pacemaker * rib fracture * infection on chest

Keywords: acute respiratory failure vibration; exposure covid-19
effect of continuous ghrp-3 infusion at on gh-igf-i system, blood pressure, glucose, and insulin resistance

Conditions: Insulin Resistance; Endothelial Dysfunction

Summary: the hypothesis is that ghrp-3 will exert beneficial effects on endothelial function and insulin resistance in older men and women via hormonal (gh, igf-i, igfbp-3,-1, insulin) and non-hormonal actions (anti-inflammatory).

at the lower dose of 0.1 µg/kg/h, ghrp-3 presumably will improve endothelial dysfunction, enhance insulin action and lower blood pressure via the anti-inflammatory effects of ghrp-3 while at the higher dose of 0.5 µg/kg/h ghrp-3 these anti-inflammatory effects will be further augmented by the hormonal action of increasing serum igf-i and its primary serum binding protein insulin like growth hormone binding protein - 3 (igfbp-3 as well as -1). also, the more detailed inter-relationships between the actions of ghrp-3, gh and igf-i on serum glucose, blood pressure, and lipid levels over 24h periods will be determined at the end of the 14 day placebo and two ghrp-3 infusion periods. the ghrp-3 will be administered in escalating doses. the specific aims of this study are as follows: 1. to determine the relative effects of 0.1µg/kg/h and 0.5µg/kg/h ghrp-3 as compared to placebo infusion in inducing physiological secretion of the gh-igf-i system after continuous sc delivery for 14 days in healthy older men and women with insulin resistance. 2. to determine the relative interrelated effects of 0.1 and 0.5µg/kg/h ghrp-3 infusion and placebo on various hormonal and non hormonal aspects of insulin resistance such as blood pressure (bp), plasma glucose and ffa as well as gh, igf-i, igfbp-1, -3, insulin and endothelin-1 levels. 3. to determine the relative effects of placebo and the above 2 doses of ghrp-3 infusion on flow mediated dilation (fmd) and nitroglycerin-dependent dilation

Eligibility criteria:
inclusion criteria: 1. men and post-menopausal women 50-70 years. 2. elevated fasting plasma glucose ranging \<125 mg/dl 3. waist circumference \>35 inches in women and \>40 inches in men exclusion criteria: 1. patients taking medications that may alter carbohydrate metabolism and/or insulin resistance. 2. female patients with a positive pregnancy test. 3. previous history of hypersensitivity to ghrp. 4. patients with overt liver disease, renal disease and/or congestive heart failure. 5. patients with anticipated change in medication regimen during the study period. 6. current use or history of use of hormone replacement therapy in the last six months. 7. current use or history of use of ace inhibitors or angiotensin receptor blockers in the last six months. 8. hemoglobin of \< 11.6 g/dl for women and \< 12.9 g/dl for men.

Keywords: ghrp-3 insulin resistance markers of inflammation endothelial dysfunction flow mediated dilation gh/igf-1 axis post menopausal
ciclops immune checkpoint inhibitors neurotoxicity: long-term outcomes, predictors, and survival.

Conditions: Paraneoplastic Syndromes

Summary: immune-checkpoint inhibitors (icis) have radically changed the therapy of cancer in recent years. icis promote antitumor immune response inhibiting one of the following immune checkpoints: cytotoxic t-lymphocyte antigen-4 (ctla-4; ipilimumab), programmed death-1 (pd-1: pembrolizumab, nivolumab, and cemiplimab), and programmed death ligand-1 (pd-l1: atezolizumab, durvalumab, and avelumab). despite the desired effect as cancer treatment, icis can break immune tolerance to self-antigens and induce specific toxicities known as immune-related adverse events (iraes), that may affect both peripheral and central nervous system (neurological immune mediated adverse events, niraes). the pathogenic mechanisms underlying niraes are probably heterogeneous, as reflected by the variety of clinical phenotypes and severity. niraes are rare, but there is some concern that the incidence may increase in the next future, in particular because icis are being used more and more for cancers commonly associated with paraneoplastic neurological syndromes (e.g. small-cell lung cancer). moreover, niraes are usually severe, and often fatal. indeed, iraes-related complications are the most common cause of death among these patients. on the other hand, these patients usually have a good tumor response to immunotherapy. there is some evidence that iraes may predict icis efficacy and consequently nirae surivors are likely to have longer life expectancy than non-nirae patients. therefore, it is of utmost importance to better characterize the long-term outcomes of nirae patients in terms of neurologic disability and mortality, and to identify predictors of severe niraes. so far, only few studies with sufficient follow-up have been published on the topic, and they included only small number of patients. the aims of our study is to characterize the main clinical and paraclinical features of niraes in a large cohort of nirae patients, to assess long-term outcomes and to identify prognostic factors. this study will help define new guidelines regarding nirae prediction and management.


Eligibility criteria:
inclusion criteria: * patients who developed niraes (grade severity equal or more than 3 according to ctcae) exclusion criteria: * alternative better explanation for neurological symptoms (cancer progression, carcinomatous meningitis, complications of other treatments..)

Keywords: icis niraes paraneoplastic neurological syndromes neurological toxicity immune checkpoint inhibitors
hfho vs cpap during thoracic surgery

Conditions: Hypoxaemia During Surgery; Lung Hyperinflation

Summary: a single institutional cross-over study design to compare between high flow humidified oxygen (hfho) device versus conventional cpap for non-ventilated lung during thoracic surgery.

the investigators hypothesize that hfho may be an alternative tool to supply oxygen to non-ventilated lung during one lung ventilation. cpap can improve oxygenation at a cost of lung hyperinflation which is an unwanted condition during thoracic surgery especially the video-assisted one. recruiting adult patients who undergo lung surgeries that requires one-lung ventilation. exclusion criteria include the followings:- 1. emergency case. 2. patients with severe copd(chronic obstructive pulmonary diseases). 3. patients with moderate baseline hypoxemia (spo2 \< 90% on room air). 4. patients with severe hemoptysis. 5. patients with upper or lower airway abnormalities. 6. patients undergo pulmonary lavage. 7. patients with known pulmonary hypertension. 8. patients with known pulmonary/tracheobronchial infections. 9. patients with suspected difficult airway. 10. patients with bmi over 35. 11. pregnant patients. following a standard anesthetic practice. all participants will receive an intravenous based anesthetic with or without regional blocks. the appropriate sized double lumen endobronchial tube will be placed and fiberoptic bronchoscope is used to verify a proper position. patient will also get an arterial line for frequent abg (arterial blood gases) samplings. computer generated randomization will divide patients into 2 groups. baseline abg will be drawn. after one lung ventilation commenced for 20 minutes, the 2nd abg will be drawn, the surgeon who was blinded to the intervention will evaluate the quality of lung collapse using 5-point likert scale. then, patients will either receive a cpap or hfho (depends on randomization) for 20 minutes. up on 1st intervention completion, the 3rd abg and lung collapse evaluation will be performed. following the first intervention, the non-ventilated lung will be suctioned out and wait for 20 minutes. another abg will be sampled at this point. the patient will receive the 2nd alternative intervention (cpap or hfho- depend on their randomization) for 20 minutes. the final abg and lung collapse evaluation will be performed. if any severe hypoxemia/ hypercarbia and marked violation of protocol occurs. patients will be excluded.

Eligibility criteria:
inclusion criteria: * all adult \> 18 years of age undergoes lung surgeries that required one-lung ventilation exclusion criteria: * emergency case * severe copd * moderate baseline hypoxemia * pulmonary hypertension * difficult upper/lower airway * bmi \> 35 * severe pneumonia * bronchial lavage * massive hemoptysis

Keywords: high flow oxygen device, hfho, cpap, one-lung ventilation
amg 386 phase 2 open-label renal cell carcinoma (rcc) study 1st line or after cytokine failure in combination with sunitinib

Conditions: Advanced Renal Cell Carcinoma

Summary: this phase 2 study is an open-label, multi-center study to determine the safety and tolerability of amg 386 in combination with sunitinib in the treatment of subjects with metastatic renal cell carcinoma.


Eligibility criteria:
inclusion criteria: * subjects must have a histologically confirmed metastatic renal cell cancer (rcc) with a clear cell component * low or intermediate risk according to the memorial sloan kettering cancer center (mskcc) prognostic risk classification * measurable disease with at least one unidimensionally measurable lesion per response evaluation criteria in solid tumor (recist) guidelines with modifications * adequate organ and hematological function as evidenced by laboratory studies conducted at screening * eastern cooperative oncology group (ecog) of 0 or 1 exclusion criteria: disease related * known history of central nervous system metastases. * previous treatment (excluding surgery, prior cytokine-based immunotherapy and palliative radiotherapy) for advanced or metastatic renal cell carcinoma * focal radiation therapy for palliation of pain from bony metastases within 14 days of enrollment. medications * currently or previously treated with sunitinib or other small molecule inhibitors of vascular endothelial growth factor (vegf) * currently or previously treated with agents that neutralizing vegf * currently or previously treated with amg 386, or other molecules that inhibit the angiopoietins or tie2 receptor * currently or previously treated with agents inhibiting the mammalian target of rapamycin (mtor) * current or within 30 days prior to enrollment treatment with immune modulators * concomitant or previous use within 30 days prior to enrollment of any strong inducer of cyp3a4 * concomitant or previous use of amiodarone within 6 months prior to enrollment general medical * clinically significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent * major surgery within 28 days prior to enrollment or still recovering from prior surgery * uncontrolled hypertension as defined as diastolic \> 90 mmhg or systolic \>150 mmhg. the use of anti-hypertensive medications to control hypertension is permitted. other * other investigational procedures are excluded * subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s) other inclusion/exclusion criteria may apply, per protocol.
study comparing local/ mac anesthesia in lumbar decompression

Conditions: Lumbar Spinal Stenosis

Summary: explore efficacy, complications, and other factors associated with anaesthetic choice- to evaluate the efficacy of local + mac as an alternative anesthetic to general anesthesia and to analyze patients' outcomes and experiences.

100 patients ages 40-95 with lumbar stenosis to be decompressed are randomized to undergo the procedure with either general anesthesia or local anesthetic with mac. participants will be randomized to either group 1 general anesthesia or group 2 local + mac anesthetic group. group 1: general anesthesia: medically induced unconsciousness that suppresses reflexes and requires intubation (a tube inserted through the mouth and into the airway) to assist in breathing. group 2: local + mac: local anesthetic (lidocaine) injected into the site of the incision/dissection with additional iv medication (propofol) to achieve a state in which the patient is generally aware, but relaxed

Eligibility criteria:
inclusion criteria: patients with lumbar stenosis to be decompressed over 1-3 segments * ages 40-95 * appropriate for general anesthesia exclusion criteria: * planned significant nerve root retraction * previous fusion operation * unable to comply with follow up * patients with daily morphine equivalents or more 100mg * patients with a known hypersensitivity to propofol or any of diprivan injectable emulsion components. * patients with allergies to eggs, egg products, soybeans or soy products.
short term efficiency of presurgical vacuum formed nasoalveolar molding aligners in infants with bilateral cleft lip and palate compared with grayson acrylic formed nasoalveolar molding appliances.

Conditions: Cleft Lip and Palate; Bilateral Cleft Lip/Palate

Summary: newborns with bilateral cleft lip/ palate will be treated pre-surgically by either presurgical vacuum-formed nasoalveolar molding aligners vf (nam) or conventional grayson acrylic formed nasoalveolar molding appliances in order to evaluate their effect on the maxillary arch.

the aim of this trial is to evaluate and compare the short-term effect of vf (nam) aligners with conventional grayson appliances at 2 stages t1 (before nam therapy), and t2 (after nam therapy) as regards maxillary arch changes. newborns with bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive presurgical vacuum-formed nasoalveolar molding aligners while the second group will receive conventional grayson acrylic formed nasoalveolar molding appliances. the follow-up period will be 4-6 months till surgical lip closure. the changes in the maxillary arch will be assessed by digital maxillary models.

Eligibility criteria:
inclusion criteria: * non-syndromic infants with complete bclp infants * infants less than 1 month of age * males and females. * infants with displaced premaxilla * patients whose parents provided written consent for the study. exclusion criteria: * patients above 1 month of age * syndromic and systemically ill infants. * patients with unilateral cleft lip and palate. * incomplete cleft lip. * medically compromised patients * patient's/guardians who will be unwilling to go through the pnam therapy
fgl2/fibroleukin and hepatitis c virus recurrence post liver transplantation

Conditions: Liver Transplantation; Hepatitis C

Summary: the main objective of this study is to assess whether a recently-developed bioassay for the molecule "secreted fibrinogen-like protein 2" (sfgl2) can be used to predict the recurrence and/or progression of hepatitis c virus disease in post liver transplant patients. the hypothesis is that patients with chronic hcv have higher than normal levels of sfgl2 in their blood both pre- and post-transplantation and that this will inhibit their ability to clear hcv, and influence the progression of hcv disease when it recurs.

hepatitis c virus infection (hcv) is a serious health problem worldwide, accounting for significant morbidity and mortality. the current treatment, combination therapy with pegylated ifna/ribavirin results in only a 50% sustained viral response such that hcv is now the leading indication for liver transplantation. unfortunately, hcv recurrence post-transplantation is universal and it is often difficult to distinguish recurrent hcv from other processes such as rejection, leading to inappropriate or delayed treatment(s) and compounding graft damage. it would be beneficial to have access to a circulating biomarker to distinguish hcv disease recurrence from other processes and to predict the severity of hcv disease progression post-transplantation. the molecule fgl2 is secreted by cells of the immune system and may be a key immunomodulator affecting graft survival and hcv recurrence. the aim of this study is to assess whether a bioassay for fgl2 can predict hcv disease recurrence and progression after liver transplantation and/or differentiate hcv disease recurrence from acute cellular rejection. this study will also examine the form of fc receptor expressed in these patients. the fc receptor is hypothesized to be the binding partner of fgl2.

Eligibility criteria:
for hcv positive subjects: inclusion criteria: 1. able and willing to give written informed consent 2. willing to follow the study protocol 3. diagnosis of chronic hcv infection based on two positive serology tests 4. no history of active alcohol or drug abuse 5. all six viral genotypes are considered 6. pre- and post transplant viral load data must be available exclusion criteria: 1. pregnancy 2. hbv, hdv or hiv co-infection for non-hcv subjects: inclusion criteria: 1. able and willing to give written informed consent 2. willing to follow the study protocol exclusion criteria: 1. free from infection by any of the following: hcv, hbv, hdv or hiv.
study to assess the pharmacokinetics of ct1812 in older healthy volunteers

Conditions: Alzheimer Disease

Summary: this an open label study to assess the pharmacokinetics of ct1812 in normal healthy volunteers.

open label study to assess pk in 36 older healthy volunteers. subjects will be screened 35 days prior dose to determine eligibility. on day -1 subjects will be admitted to the clinical research unit and on day 1 will be randomized to receive one of the following doses: 150 mg bid, 150 mg qd or 300 mg qd in the fed state. subjects will be confined in the clinical research unit where they will continue to receive study drug and complete safety assessments, pk and csf draws, until day 16 when they will be discharged.

Eligibility criteria:
inclusion criteria: * men and women 50-80 years of age, inclusively * in good health as determined by the investigator with no clinically significant abnormalities * weight between 50.0 and 100.0 kg, inclusive at screening * no suicidal ideation * no active depression * living independently at home or in a community setting * able to swallow ct1812 capsule or capsules * non-smoker with no history of using tobacco or any nicotine-containing products * subjects with negative serology for hiv, hepatitis b, and c * negative results for drugs of abuse, cotinine, and alcohol * negative test results for covid-19 * willing to comply with clinical pharmacology unit's covid-19 policies exclusion criteria: * any chronic medical condition which, in the opinion of the investigator, might pose a safety risk to the subject or interfere with study interpretation * subject with active or recent infection requiring antibiotic therapy * medical history of vasculitis or any autoimmune disease * any recent hospitalization * subjects living in a continuous care nursing facility * any contraindication to a lumbar puncture * subjects with self-reported history of major depression * history of diabetes * intake of drugs or substances potentially involved in clinically significant induction or inhibition of cyp3a4 or p-gp mediated drug interactions with ct1812 * intake of investigational drug prior to study drug administration on day 1 * participation in an investigational device study prior to study drug administration on day 1 * grapefruit, grapefruit juice, and seville oranges/juice must be avoided within 14 days prior to dosing and throughout the course of the study * suspected or known drug or alcohol abuse, * excessive consumption of coffee, tea, cola, or other caffeinated beverages * loss or donation of blood; nation of bone marrow or peripheral stem cells; or donation of plasma * venous access considered inadequate; history or evidence of adverse symptoms associated with phlebotomy or blood donation * suspected or known allergy to any component of the study treatments * employee or family member of the investigator, study site personnel, or sponsor * a subject with any condition that, in the opinion of the investigator, makes the subject unsuitable for study participation will be excluded
a study with eptinezumab in children and adolescents (6 to 17 years) with chronic or episodic migraine

Conditions: Migraine

Summary: the main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

this is an extension study for participants aged 6 to 17 with migraine who completed either studies 19356a (nct04965675) (chronic migraine \[cm\] study in adolescents) or 19357a (episodic migraine \[em\] study in children and adolescents). all participants who complete the week 12 visit of the respective lead-in study will be offered participation in this open-label extension (ole) study, unless there is a safety concern precluding a participant's participation in the study. participants originally randomized to 100 milligrams (mg) (weight adjusted) in the double-blind lead-in study (study 19356a or study 19357a) will continue on the same dose (100 mg, weight adjusted) in the ole study. participants randomized to the 300 mg dose (weight adjusted) in the double-blind lead-in study will continue on 300 mg (weight adjusted) in the ole study. participants who were assigned to placebo in the double-blind lead-in study will be randomly allocated to one of the two treatment groups: eptinezumab 100 mg (weight adjusted) or eptinezumab 300 mg (weight adjusted) with a ratio of 1:1.

Eligibility criteria:
inclusion criteria: - the participant must have completed week12 (completion) visit of either study19356a (cm) or study19357a (em) immediately prior to enrolment into this ole study. exclusion criteria: * the participant has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator. * during lead-in study19356a or study19357a: * participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (imp) infusion, as assessed by the investigator * the participant had a serum alanine aminotransferase (alt) or aspartate aminotransferase(ast) value \>5 times the upper limit of the reference range that was confirmed by testing \<2 weeks later. * the participant had a serum alt or ast value \>3times the upper limit of the reference range and a serum total bilirubin value \>2times the upper limit of the reference range.