Kornimate/medical-research-clean huggingface dataset:
study comparing som230 subcutaneously and sandostatin subcutaneously in acromegalic patients

Conditions: Acromegaly

Summary: 5 month study comparing som230 s.c. and sandostatin s.c. in acromegalic patients.


Eligibility criteria:
inclusion criteria: * patients with active acromegaly due to a pituitary adenoma * patients who have been previously treated for acromegaly with certain medications may be required to be without certain medications prior to entering the study exclusion criteria: * patients with compression of the optic chiasm causing any visual field defect * patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression * patients who have received radiotherapy in the 2 years prior to the start of the trial * patients who have congestive heart failure, unstable angina, cardia arrhythmia, or a history of acute myocardial infarction within the three months preceding enrollment * patients with gallstone disease * patients with chronic liver disease * known hypersensitivity to sandostatin or sandostatin lar * female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control and highly effective method for birth control * history of immunocompromise, including a positive hiv test result * patients who have a history of alcohol or drug abuse in the six-month period prior to the enrollment visit * patients who have participated in any clinical investigation with an investigational drug within 4 weeks prior to dosing

Keywords: acromegaly som230 sandostatin
generic mycophenolate mofetil safety study for prophylaxis in de novo renal transplant patients in jordan

Conditions: Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant

Summary: the purpose of this observational study was to assess the safety and efficacy of generic mycophenolate mofetil in de novo renal transplant patients in jordan where no visits or intervention(s) additional to the daily practice were performed.

a single center, observational, open-label, longitudinal, prospective study combined with retrospective data collection for 12 de novo renal transplant patients. ten patients were prospectively followed for 12 months after receiving myora® (mycophenolate mofetil) and two patients were previously on myora® (mycophenolate mofetil), thus their data was retrospectively collected from their hospital records and all relevant workup tests results. outcomes include occurrence of aes and proportion of patients with normal graft function.

Eligibility criteria:
inclusion criteria: * patient received de novo renal transplant * patient treated with myora® according to the attending physician's judgment (either post-transplant or induction) * patient provided written informed consent exclusion criteria: * hypersensitivity to mycophenolate mofetil, mycophenolic acid (mpa) or any of the constituents of myora®

Keywords: myora mycophenolate mofetil end stage renal disease de novo renal transplant post authorization safety study immunosuppressant cohort study
lactulose, l-ornithine l-aspartate, or rifaximin versus placebo for preventing hepatic encephalopathy in variceal bleeding

Conditions: Hepatic Encephalopathy

Summary: the aim of this study is to determine whether lactulose, l-ornithine l-aspartate, and rifaximin are effective in the prevention of the development of hepatic encephalopathy in cirrhotic patients with acute variceal bleeding


Eligibility criteria:
inclusion criteria: -cirrhotic patients with acute variceal bleeding, without minimal or clinical hepatic encephalopathy according to phes, cff and west-haven criteria exclusion criteria: * age under 18 year-old or over 65 year-old, with any other neuropsychiatric disorder or dementia, presence of active bacterial or fungal infections, receiving antibiotics for any cause, previous diagnosis of hepatic encephalopathy and receiving therapy with lactulose, rifaximin, l-ornithine l-aspartate, source of bleeding different from variceal origin, serum creatinine greater than 2.0 mg/dl or with chronic renal failure. therapy in the previous six months with any of the drugs that will be used in this clinical trial.

Keywords: hepatic encephalopathy acute variceal bleeding cirrhosis
the effect of intravenous lidocaine on pain after lumbar spinal fusion

Conditions: Postoperative Pain

Summary: this prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing 1-level posterior lumbar fusion. a total of 54 patients will be randomized into one of two groups (group c or group i) based on excel number generation. patients in group c will receive received normal saline intravenous injection, and patients in group i will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr. visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (fpb) of a patient-controlled analgesia system will be recorded at 4, 12, 24, 48 hours postoperatively.


Eligibility criteria:
inclusion criteria: * 1-level posterior lumbar fusion exclusion criteria: * mental change * allergy to local anesthetics * chronic analgesics user

Keywords: pain preemptive lidocaine intravenous lumbar fusion
in vitro detection of tissue abnormality

Conditions: Breast Cancer Female

Summary: intraoperative ex-vivo use of the clearedge imaging device in breast conserving surgery to image the excised tissue surgical margins. the study is designed to demonstrate reduction in the need for repeat surgeries after breast conserving surgeries by using the clearedge as an adjunct imaging device to the standard of care.

intraoperative real-time margin assessment of breast conserving surgeries can reduce the need for repeat operations due to cancer involved margins. repeat operations result in excessive removal of benign tissue, increased risk for infection, slower healing and inferior cosmetic results. in the current standard of care, the status of the margins is determined by pathology only several days after surgery. an intraoperative assessment of the margins enables complete tumor excision in a single surgery. the proposed randomized controlled study will evaluate the benefits of adding the clearedge imaging device to the standard of care (soc) of margins assessment in breast conserving surgeries. the study will assess whether there is an improvement in the detection of cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the soc, which does not use the device. clearedge is a ce marked device already been used in several hospitals in the uk. it was used in a prospective single arm and 2 phases clinical study. it was demonstrated that surgeons successfully used the device to identify cancer involved margins and that it can reduce the need for repeat surgeries by meeting the margins depth criteria to require repeat operations. european journal of oncology surgery. 2016; 42 (12): 1834-1840. in addition, the device was clinically evaluated by several hospitals.

Eligibility criteria:
inclusion criteria: * patients aged 25-80 who are scheduled for surgical excision of tissue. exclusion criteria: * no prior history of surgery at location of current surgery.
pectoralis and serratus nerves block in thoracic surgery

Conditions: Anesthesia; Surgery; Block; Thoracic Injury

Summary: a new conceptual regional anesthesia the pecs ii block (modified pectoral and serratus nerves block) has been described for pain control after thoracic surgery, one of the indications to perform this method is analgesia for surgeries or procedures involving lateral chest wall

the pecs i block was found to be very effective after breast cancer surgery and sub-pectoral prosthesis for pain control management. this block is provided by injection into another myofascial plane, this time between pectoralis minor and serratus anterior muscle at the level of 3rd and 4th rib.pecs ii block is simple in performance with a high success rate and minimal incidence of complications, especially, if used ultrasound approach that gives a good understanding of anatomy of the lateral thoracic wall. in present clinical trial we are going to compare pecs block for pain control with traditional pain management techniques based on iv opioids and nsaids treatment in patient undergoing thoracic surgery in early postoperative period.

Eligibility criteria:
inclusion criteria: 1. all patients undergoing thoracic surgery, older ≥18 years 2. patients who meet criteria of asa i-ii-iii class. exclusion criteria: 1. patients who will be unconscious or mentally incompetent 2. patients refusal to participate in the study 3. asa -iv -v 4. patient with coagulopathy 5. hemodynamically unstable (systolic bp \ 100) 6. allergy to local anesthetic drugs or opioids 7. pregnant patient 8. history of opioid abuse
st-segment resolution as a marker for myocardial scar in st-segment elevation myocardial infarction

Conditions: Cardiovascular Diseases

Summary: clinical studies found that poor st-segment resolution (str) in electrocardiogram (ecg) occurred in major adverse cardiovascular events (mace), arrhythmia and heart failure was significantly higher . in clinical work, in patients have poor st-segment decline, the investigators found by cmr-lge the corresponding myocardium become thinner and other signs of myocardial scar. the investigators aimed to establish whether poor st-segment resolution in ecg, as well as cmr-lge, could detect the presence of myocardial scar in early stemi patients. in order to provide convenient, cheap and widely used test method for patients who cannot tolerate cmr-lge. 42 stemi patients with single-branch coronary artery stenosis or occlusion were enrolled. st-segment elevations were measured on the baseline and 24 hours after pci. the study population was divided into two groups by late gadolinium enhanced cardiac magnetic resonance (lge- cmr), with transmural myocardial scar (\>75%) or non-transmural myocardial scar (\<75%).


Eligibility criteria:
inclusion criteria: 1. single-branch coronary artery stenosis or occlusion 2. restoration of coronary perfusion to timi flow grade 3 after pci exclusion criteria: 1. a prior history of the acute coronary syndrome 2. coronary revascularization 3. severe chronic kidney disease 4. intracardiac pacing leads or other implants precluding cmr-lge 5. hemodynamic instability 6. known claustrophobia
youth partners in care: depression and quality improvement

Conditions: Depression

Summary: this randomized effectiveness trial evaluates a quality improvement intervention aimed at providing access to evidence-based depression treatments (particularly cognitive-behavior therapy for depression and or pharmacotherapy) through primary care for youth ages 13-21, as compared to enhanced usual care. the major hypothesis is that the quality improvement intervention will be associated with improved outcomes, relative to enhanced usual care.


Eligibility criteria:
inclusion criteria: * met either of two criteria: 1) endorsed "stem items" for major depression or dysthymia from the 12-month composite international diagnostic interview(cidi-12,2.1) modified slightly to conform to diagnostic criteria for adolescents, 1-week or more of past-month depressive symptoms, and a total center for epidemiological studies- depression scale(ces-d)40 score ≥ 16, or 2) ces-d score ≥ 24. * age 13-21 * presented at primary care clinic exclusion criteria: * not english-speaking * provider not in study * sibling already in study * completed eligibility screener previously

Keywords: depression quality improvement treatment adolescents
evaluation of safety and efficacy of the accero® (heal) stent for intracranial aneurysm treatment

Conditions: Intracranial Aneurysm

Summary: this study is intended to show that the application of the accero® (heal) stent is safe within the given indication.


Eligibility criteria:
inclusion criteria: any patient treated with accero® (heal) stent according to ifu and has signed the informed consent exclusion criteria: - patient is participating in another clinical trial
enb vs. conventional bronchoscopy with fluoroscopy for safe and effective biopsy of pulmonary lesions

Conditions: Lung Neoplasms; Pulmonary Neoplasm

Summary: evaluate results for participants with lung lesions randomized to either 4d electromagnetic navigation bronchoscopy (4d-enb) versus conventional bronchoscopy with fluoroscopy for diagnostic biopsy and detection of lung cancer.

the objective of this clinical trial is to evaluate the safety and efficacy results for two bronchoscopic biopsy techniques for sampling lung lesions: either image-guided electromagnetic navigation or conventional bronchoscopy with fluoroscopy. the diagnostic yield and adverse events of participants prospectively randomized to either arm will be evaluated. this is a prospective, randomized, multi-center study.

Eligibility criteria:
inclusion criteria: * subjects must meet all of the following criteria to be selected: 1. be older than 18 (including 18) and younger than 75 (including 75); 2. the population with peripheral lung lesions detected in chest ct scanning and who require biopsy; 3. the subjects are willing to undergo bronchoscopy and meet the requirements for bronchoscopy; 4. the subjects or their guardians can understand the trial objective, volunteer to participate and sign the informed consent form. exclusion criteria: * subjects will be excluded if they meet any of the following criteria: 1. the patient is participating in another drug or medical device clinical trial (drug clinical trial within 3 months or medical device clinical trial within 1 month); 2. women of childbearing age who have positive pregnancy test result and lactating women; 3. allergic to anesthetics; 4. bronchoscopy contraindications, including: active massive hemoptysis; recent myocardial infarction or unstable angina pectoris; severe heart and lung dysfunction; severe hypertension and arrhythmia; uncorrectable bleeding tendency (such as severe coagulation disorders, uremia and severe pulmonary hypertension); severe superior vena cava obstruction syndrome; suspected aortic aneurysm; multiple pulmonary bullae; systemically extreme exhaustion. 5. visible intraluminal lesions found during bronchoscopy; 6. patients with severe lung diseases (including: severe bronchodilatation, severe emphysema, etc.) and patients determined to be unsuitable for the examination by the investigators; 7. patients with a pacemaker or defibrillator; 8. patients who cannot cooperate with the doctor to complete bronchoscopy, such as patients with mental and neurological diseases, mental retardation and mental disorders; 9. patients to whom bronchoscopy and bronchoscopic sampling are not applicable to diagnose the lesions, or other patients determined to be unsuitable for this trial by the investigators.

Keywords: peripheral pulmonary lesion lung biopsy electromagnetic navigation bronchoscopy bronchoscopy fluoroscopy
a study evaluating venetoclax alone and in combination with azacitidine in participants with relapsed/refractory myelodysplastic syndromes (mds)

Conditions: Myelodysplastic Syndromes (MDS)

Summary: this is a phase 1b, open-label, multicenter study designed to evaluate the safety and pharmacokinetics of venetoclax as a single-agent and in combination with azacitidine in participants with relapsed/refractory myelodysplastic syndromes (mds).


Eligibility criteria:
inclusion criteria: * subjects who have relapsed or refractory mds. * subject enrolled in venetoclax monotherapy must have documented failure of prior therapy with a hypomethylating agent (hma). hma-failure is defined as: 1. relapse after initial complete or partial response or hematological improvement after at least 4 cycles of azacitidine or at least 4 cycles of decitabine within the last 5 years, or 2. failure to achieve complete or partial response or hematological improvement after at least 4 cycles of azacitidine or at least 4 cycles of decitabine within the last 5 years * subjects must have presence of \< 20% bone marrow blasts per bone marrow biopsy/aspirate at screening. * subject is not a candidate to undergo allogenic hematopoietic stem cell transplantation (hsct). * subject must have an eastern cooperative oncology group (ecog) performance score of ≤2. * subject must have adequate hematologic, renal, and hepatic function. exclusion criteria: * subject has received prior therapy with a bh3 mimetic. * subject has mds evolving from a pre-existing myeloproliferative neoplasm (mpn). * subject has mds/mpn including chronic myelomonocytic leukemia (cmml), atypical chronic myeloid leukemia (cml), juvenile myelomonocytic leukemia (jmml) and unclassifiable mds/mpn. * subject has received allogeneic hsct or solid organ transplantation. * subject has received a live attenuated vaccine within 4 weeks prior to the first dose of study drug. * subject is pregnant or breastfeeding.

Keywords: relapsed/refractory venetoclax azacitidine
registry study - whipple at the splenic artery

Conditions: Pancreas Cancer

Summary: the purpose of this study is to determine how effective whipple at the splenic artery (watsa).

primary the primary objective of this registry study is to collect clinical data from patients who undergo the watsa procedure. specific hypotheses to be tested are * to determine how effective whipple at the splenic artery (watsa) is at resecting tumors with negative microscopic margins (r0) at the resection line on the pancreas and at the tangential posterior, uncinate, and venous margins. * to determine if watsa can be performed within the usual range of morbidity and mortality (30 day postoperative mortality) for a standard a whipple procedure. secondary the secondary objectives of this registry study are to * to determine the survival/recurrence rates at 2 years. * to determine the effect of occlusion of the splenic vein at the confluence.

Eligibility criteria:
eligibility criteria - prospective portion: * patient must have diagnosis of ductal adenocarcinoma of head and/or neck of pancreas, ampullary adenocarcinoma, or pancreatic neuroendocrine tumor confirmed by tissue diagnosis. * patient must be between 18 to 85 years of age. * patient must be a candidate for the watsa procedure or have had the watsa surgery performed within 1 year. * patient must be able to understand and willing to sign a written informed consent document. eligibility criteria - retrospective portion: patient underwent watsa procedure at our institution between 01/01/2009 and 12/31/2011.
phase 3 study of alk-001 in geographic atrophy

Conditions: Geographic Atrophy; Age Related Macular Degeneration; AMD; Atrophy, Geographic

Summary: this is a double-masked, multicenter, randomized, placebo-controlled clinical trial, evaluating the efficacy and safety of alk-001 in participants with geographic atrophy (ga) secondary to age-related macular degeneration (amd). up to 200 participants will receive alk-001 while up to 100 participants will receive a placebo.

there is no treatment available for geographic atrophy secondary to amd. amd is characterized by an age-related degeneration of the retina. the root cause for this degeneration or why some people develop amd while others do not, is unknown. over 20 years ago, it was hypothesized that the dimerization of vitamin a may be a significant contributor to the etiology of amd. the eye indeed uses vitamin a as a cofactor to sense light, and a striking chemical signature of the aging and degenerating retina is the accumulation of vitamin a dimers in the retinal pigment epithelium (rpe) and the underlying bruch's membrane. in rodent models, high levels of vitamin a dimers correlate with poor retinal health, and a variety of mechanisms have been proposed by which vitamin a dimers may induce retinal toxicity. it has been argued that these mechanisms participate in the development and progression of amd. alk-001, the study drug, is a modified form of vitamin a. when taken once a day as a capsule, it replaces natural vitamin a in the body with one that forms vitamin a dimers more slowly. this study will measure the extent to which treatment with alk-001 slows the progression of geographic atrophy.

Eligibility criteria:
major inclusion criteria: - at least one eye with geographic atrophy secondary to dry age-related macular degeneration (amd) major exclusion criteria: - medical condition, which may interfere with the progression of ga, prevent performance of study procedures, compliance with protocol, or continuous participation in the study
gastric tolerability and pharmacokinetics of dmmet-01

Conditions: Healthy

Summary: the purpose of this study is to determine the gastric tolerability and the pharmacokinetics of a new drug for the treatment of type 2 diabetes, dmmet-01, in healthy volunteers.


Eligibility criteria:
inclusion criteria: * mexican healthy subjects with normal clinical laboratory test results and imaging (hematology, blood chemistry, urine test, vdrl, hepatitis b, hiv, chest radiography and electrocardiogram) exclusion criteria: * familiar or personal history of diabetes * history of drug or alcohol abuse within the 2 years prior to the study * a smoking habit greater tha 10 cigarettes per day * intercurrent disease * intercurrent treatment with any drug

Keywords: pharmacokinetics diabetes gastric tolerability
evaluation of peripheral itch mechanisms following injection of morphine

Conditions: Morphine; Histamine; Cowhage; Isotonic Saline

Summary: the aim of this study is to the effect of opioid (morphine) intradermal application on histaminergic and non-histaminergic itch. in particular, we would like to demonstrate that also peripheral administration of morphine may affect mast cell release of histamine.

opioids (i.e. substances extracted from opium poppies, e.g. morphine) are used for treatment of both acute and chronic pain conditions as well as in surgical procedures. opioids render effective pain relief, however, they may cause bothersome itch as a side effect. with this series of experiments, we wish to clarify how an injection with morphine in the skin layer called dermis (located right below the upper skin) will affect itch.

Eligibility criteria:
inclusion criteria: * healthy men and women * 18-60 years * speak and understand english exclusion criteria: * participants with any clinically significant abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results. * pregnancy or lactation * drug addiction defined as any use of cannabis, opioids or other addictive drugs * lack of ability to cooperate * current use of medications that may affect the trial such as antihistamines, antipsychotics and pain killers as well as systemic or topical steroids. * participants with known allergy/discomfort to the opioid morphine and antihistamine. * skin diseases * moles, scars or tattoos in the area to be treated or tested. * consumption of alcohol or painkillers 24 hours before the study days and between these * acute or chronic pain * participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)