Kornimate/medical-research-clean huggingface dataset:
a study of ramucirumab (ly3009806) in combination with erlotinib in previously untreated participants with egfr mutation-positive metastatic nsclc (relay)

Conditions: Metastatic Non-Small Cell Lung Cancer

Summary: the main purpose of this study is to evaluate the efficacy and safety of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in previously untreated participants with stage iv non-small cell lung cancer (nsclc) harboring an activating epidermal growth factor receptor (egfr) mutation (exon 19-del and exon 21 l858r). safety and tolerability of ramucirumab in combination with erlotinib will be assessed in part a before proceeding to part b. the purpose of part c is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated east asian participants with egfr mutation-positive metastatic nsclc and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have t790m - positive metastatic nsclc.


Eligibility criteria:
inclusion criteria: * cytologically or histologically confirmed diagnosis of stage iv nsclc as defined by the american joint committee on cancer staging criteria for lung cancer (ajcc 7th edition 2009). * eligible for first-line treatment with erlotinib based on documented evidence of tumor harboring an activating egfr mutation \[exon 19 deletion or exon 21 (l858r) substitution mutation\]. * mandatory provision of adequate archived stage iv nsclc tissue samples or tissue samples other than stage iv nsclc may be acceptable (optional for part c). * at least one measurable lesion. * life expectancy of at least 3 months. exclusion criteria: * known t790m egfr mutation (not applicable for part c period 2). * known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression, or brain metastases. * serious illness or medical condition. * ongoing treatment with cyp3a4 inducers or strong inhibitors. * ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months. * history of gross hemoptysis. * significant bleeding disorders. * radiologically documented evidence of major blood vessel invasion or encasement by cancer. * radiographic evidence of intratumor cavitation. * history of gastrointestinal perforation within last 6 months. * history of bowel obstruction, inflammatory enteropathy or extensive intestinal resection. * history of any arterial thrombotic event within 6 months prior to enrollment. * the participant has any known significant ophthalmologic abnormalities of the surface of the eye.
the therapeutic effect of curcumin in nanogels compared to 0.1% fao in the management of oral lichen planus

Conditions: Oral Lichen Planus

Summary: this randomized, double-blind clinical trial evaluates the therapeutic effects of curcumin in nanogels compared to 0.1% fluocinolone acetonide oral paste in the management of atrophic-erosive oral lichen planus (olp). the study aims to determine whether curcumin nanogels, a natural treatment with enhanced bioavailability, are as effective and better tolerated than standard corticosteroid therapy.

oral lichen planus (olp) is a chronic, immune-mediated inflammatory condition that causes painful mucosal lesions and significantly impairs patients' quality of life. although topical corticosteroids are the standard treatment, their long-term use is associated with adverse effects. curcumin, a natural compound with anti-inflammatory and antioxidant properties, has shown promise as an alternative treatment. however, its clinical application is limited by poor bioavailability. this randomized, double-blind, controlled clinical trial aims to compare the therapeutic effects of curcumin in nanogels and 0.1% fluocinolone acetonide oral paste in patients with atrophic-erosive olp. thirty eligible participants will be randomly assigned to either the curcumin nanogel or fluocinolone group, and treatment outcomes will be evaluated using the oral lichen planus disease activity scale (olp-das) and a patient satisfaction questionnaire over a 4-week period. the study is conducted at the faculty of dentistry, chulalongkorn university, and seeks to evaluate whether curcumin nanogels offer comparable therapeutic efficacy to corticosteroids, with potentially fewer side effects.

Eligibility criteria:
inclusion criteria: * age 18 years or older * ability to provide written informed consent * clinically and histopathologically confirmed diagnosis of erosive or atrophic oral lichen planus (olp) * presence of symptoms (nrs pain score \> 0 at baseline) * ability to communicate and follow instructions * willingness to apply oral paste treatment and comply with study protocol exclusion criteria: * pregnancy or lactation * current orthodontic treatment * uncontrolled diabetes mellitus (hba1c \> 7% or fpg \> 130 mg/dl) * use of anticoagulants or antiplatelet agents * severe dry mouth (challacombe score \> 7) * history of gastric ulcers, duodenal ulcers, or gallstones * presence of any active malignancy or infection * use of topical/systemic treatment for olp in the past 2 weeks * current use of immunosuppressants * known allergy to corticosteroids or herbal agents such as turmeric * diagnosis of oral lichenoid contact lesion or graft-versus-host disease (gvhd) * history of allogeneic bone marrow transplantation * current smokers

Keywords: atrophic-erosive oral lichen planus curcumin nanogels fluocinolone acetonide mucosal disease autoimmune disease
phase ii study to evaluate the efficacy and safety of glassia® in type-1 diabetes

Conditions: New Onset Type-1 Diabetes

Summary: a phase ii, double-blind, randomized, placebo-controlled, multicenter, study evaluating the efficacy and safety of human, alpha-1 antitrypsin (aat) \[glassia®\] in the treatment of new onset type-1 diabetes. the study objectives are: * to assess the efficacy of intravenous aat in treatment of new onset type 1 diabetes * to assess the safety and tolerability of intravenous aat in new onset type 1 diabetes pediatric and young adult population.


Eligibility criteria:
main inclusion criteria: * subject (or parent/guardian) willing and able to sign an informed consent * age 8-25 (inclusive) years * recently diagnosed with t1dm * basal c-peptide ≥ 0.2 pmol/ml * positive for at least one diabetes-related autoantibody * ability and consent to comply with completion of patient diary * no significant abnormalities in serum hematology, serum chemistry * no significant abnormalities in urinalysis * no significant abnormalities in ecg * for women of child bearing potential, non-pregnant, non-lactating female patients main exclusion criteria: * iga deficient subjects * subjects who have received an active/ live virus vaccine within 4 weeks of the screening date * subjects who have received treatment with corticosteroid medication within 2 months prior to screening or any immunosuppressant or cytostatic agent within 6 months prior to screening * individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to plasma products * clinically significant intercurrent illnesses * pregnant or lactating women * current use of any medication known to influence glucose tolerance * current or prior (within the last 60 days prior to screening visit) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, dpp-iv inhibitors or amylin.

Keywords: type-1 diabetes t1d diabetes mellitus
stress reduction and prevention of hypertension in blacks

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to examine the role of transcendental meditation in stress reduction and prevention of hypertension in blacks.

background: african americans suffer from disproportionate rates of hypertension and related cardiovascular morbidity and mortality due, at least in part, to excessive socioenvironmental and psychosocial stress. furthermore, despite the substantial individual and population risk burden associated with high normal blood pressure (bp) in african americans, there had been no controlled studies to evaluate stress reduction approaches in the primary prevention of hypertension targeted to this high risk group. therefore, recent (mid 1990s) nih and nimh policy committees called for a new research focus on primary prevention of hypertension targeted to high risk populations-notably african americans with high normal bp. in previous randomized controlled trials by the investigator, hypertension and psychosocial stress were significantly reduced in low ses african americans who practiced stress reduction with the transcendental mediation (tm) program compared to relaxation or health education controls. in the most recent long-term trial, african americans with borderline hypertension showed bp reductions that would be associated with a 17 percent decrease in prevalence of hypertension, a 15 percent reduction in stroke, and a 6 percent reduction in chd in the population. these bp reductions compared favorably to decreases shown with sodium restriction and weight loss programs in other prevention trials. also, pilot data from two clinical trials indicated that tm was associated with significantly lower cardiovascular morbidity and mortality in african americans and in caucasians with high bp over a 5-year and 15-year period, respectively. design narrative: a randomized controlled trial of stress reduction for the primary prevention of hypertension was conducted in african americans with high normal bp. african american males and females (n-352, aged 21-75 years) with high normal bp (sbp 130-139 and/or dbp 85-89 mm hg) were recruited from the african american family heart health plan at the medical college of wisconsin, milwaukee, which housed the nation's largest registry of african americans with known cvd risk factors. after baseline assessment, participants were randomized to either the tm program or to a matched health education control intervention. the primary outcome was change in clinic bp over a 12-month follow-up. secondary outcomes included changes in ambulatory bp, hypertensive events, psychosocial stress and health behaviors. also, a model of the pathways through which components of stressful experience affect high bp in african americans was tested. this study is described as a clinical trial. the summary statement states that it is not an nih phase iii clinical trial. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
prevention of recurrent gastric or duodenal ulcers caused by low-dose aspirin with rabeprazole (e3810) treatment (planetarium study)

Conditions: Gastric or Duodenal Ulcers Caused by Low-dose Aspirin

Summary: the primary objective of this study to evaluate the effect of preventing recurrence of gastric or duodenal ulcers by administering e3810 5 mg or 10 mg tablets once daily or teprenone 150 mg/day (50 mg three times daily) as a control to patients receiving low-dose aspirin and thereby examine the superiority of e3810 over teprenone.


Eligibility criteria:
inclusion criteria * require long-term administration of low-dose aspirin (81 mg/day or 100 mg/day) * confirmed to have a history of gastric or duodenal ulcer exclusion criteria -confirmed to have acute gastro duodenal mucosal lesions, gastric or duodenal ulcer, or upper gastrointestinal (esophagus, stomach, duodenum) bleeding confirmed to have reflux esophagitis or long segment barrett's esophagus

Keywords: rabeprazole proton pump inhibitor acetylsalicylic acid aspirin gastric ulcer duodenal ulcer
adjunctive ziprasidone in the treatment of bipolar i depression

Conditions: Bipolar Disorder; Depression, Bipolar

Summary: the purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of bipolar i depression. ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on a therapeutic dose of one of these mood stabilizers for at least 4 weeks.


Eligibility criteria:
inclusion criteria: * adults meeting diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria for bipolar i disorder, most recent episode depressed, with or without rapid cycling and without psychotic features. subjects receive therapeutic dose of lithium, valproate or lamotrigine for at least 4 weeks prior to randomization. exclusion criteria: * patients with ultra-fast rapid cycling (8 or more mood episodes per year) * significant heart disease including abnormalities in the heart's rhythm (qt prolongation) * psychotic symptoms (hallucinations and/or delusions).
study to assess the efficacy and safety of mt-3921 in subjects with acute traumatic cervical spinal cord injury

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to compare the efficacy and safety of intravenous (iv) infusions of mt-3921 to placebo in subjects with acute traumatic cervical spinal cord injury. subjects meeting eligibility criteria will enter the 6-month double-blind period. subjects will be randomized in a 2:1 ratio to receive mt-3921 or placebo in a double blind manner.


Eligibility criteria:
inclusion criteria: additional screening criteria check may apply for qualification: * provide written informed consent prior to beginning any study procedures * cervical spinal cord injury that meet all of the following criteria: * classified as ais a, ais b or ais c * isncsci neurological level of injury between c4 and c7 (for c4, the subject must have at least 1 point of motor activity between c5 to c7) * uems ≤28 at screening * body mass index (bmi) \<40 exclusion criteria: additional screening criteria check may apply for qualification: * any concomitant injury that interferes with the procedures and examinations required by study protocol, including performance, interpretation or validity of neurological examinations * poly-traumatic injury as defined by injury severity score (iss) values \> 25 * penetrating spinal cord injuries * complete transection of the spinal cord * any other significant pre-existing medical conditions prior to spinal cord injury or current conditions that, in the judgement of the iinvestigator, may increase the risks associated with study participation * history of anaphylaxis or clinically significant allergic reactions to any medication * history or presence of malignancy within the last 3 years prior to screening * subjects with current sars-cov-2 infection (covid-19) * subjects with hereditary fructose intolerance * psychoactive substance use disorder * participation in any clinical trial of a new chemical entity within 12 weeks prior to screening * female subjects who are pregnant or lactating
development and prevention of pulmonary hypertension in systemic sclerosis

Conditions: Systemic Sclerosis; Pulmonary Hypertension

Summary: systemic sclerosis (ssc) is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs. pulmonary hypertension (ph) is a fatal disorder characterized by an increase in pulmonary vascular resistance, which leads to right ventricular failure. despite being recently the object of greater attention and despite therapeutic advances, pulmonary hypertension due to ssc remains associated with a dismal 47 - 67% 3-year survival. among ssc patients prospectively followed in the "european league against rheumatism scleroderma trials and research" (eustar) cohort, 26% of death was related to pulmonary hypertension. although some previous data have suggested the protective effects of calcium channel blockers on the development of pulmonary hypertension, the potential preventive effects of vasodilators for the prevention of pulmonary hypertension have not been determined yet. in addition to be considered routinely for the treatment of ssc-related pulmonary hypertension, prostanoids, endothelin receptor antagonists (etra) and phosphodiesterase-5 inhibitors (pde5i) can also be used for this indication. this observational trial is one out of five observational trials of the collaborative project "to decipher the optimal management of systemic sclerosis" (desscipher). aim of this observational trial is: - to compare the outcomes of adult and juvenile ssc patients who are at high risk of developing pulmonary hypertension and are receiving either different vasodilator treatments or no vasodilator treatment.


Eligibility criteria:
inclusion criteria: * juvenile and adult systemic sclerosis patients, with diagnosis according to the acr/eular adult ssc criteria and pres/acr/eular juvenile ssc criteria respectively * patients at high risk of pulmonary hypertension with a cochin risk prediction score \>/= 3 acr = american college of rheumatology; eular = european league against rheumatism; pres = pediatric rheumatology european society
dexmedetomidine in reducing incidence of emergence agitation after nasal surgery

Conditions: Postoperative Delirium

Summary: various pharmacological interventions have been attempted previously to prevent postoperative ea with variable results. these include use of opioids, propofol, midazolam, ketamine, magnesium and alpha-2 agonists like clonidine and dexmedetomidine. dexmedetomidine have been used with different dosages and different timings of administration with variable results and at the expense of major hemodynamic disturbances. the objective of this study was to investigate the role of single dose of dexmedetomidine (0.5 mcg/kg) administered as 30 minutes infusion prior to extubation in reducing the incidence and severity of ea and coughing on extubation.

emergence agitation (ea) or delirium is a post anesthesia complication which is manifested as confusion, agitation, disorientation and aggressive behavior. it can lead to serious consequences including hemorrhage, removal of lines, drains and catheters, self-extubation and even falling out of bed resulting in severe injuries. ea is associated with cognitive deficit, physical dependence, increased hospital stay and higher mortality. there is wide variation in the incidence of ea in scientific literature ranging from 5 % to 27.3 %. there are no clear diagnostic criteria for ea because of its varied clinical manifestations. although many risk factors have been identified including pain, presence of stress at the time of induction, induction with etomidate, use of premedication with benzodiazepines, hypoxemia, type of surgery, awakening in hostile and noisy environment and presence of urinary catheter. patients undergoing nasal surgeries are in particular, at higher risk for ea due to a sense of suffocation secondary to nasal packing. various pharmacological interventions have been attempted previously to prevent postoperative ea with variable results. these include use of opioids, propofol, midazolam, ketamine, magnesium and alpha-2 agonists like clonidine and dexmedetomidine. dexmedetomidine have been used with different dosages and different timings of administration with variable results and at the expense of major hemodynamic disturbances. the objective of this study was to investigate the role of single dose of dexmedetomidine (0.5 mcg/kg) administered as 30 minutes infusion prior to extubation in reducing the incidence and severity of ea and coughing on extubation.

Eligibility criteria:
inclusion criteria: * we will include patients aged 15 years to 65 years, asa 1-3 who are planned to undergo general anesthesia for elective nasal surgeries in which nasal packing is used postoperatively exclusion criteria: * we will exclude patients with known allergy to study medications, bmi more than 35, history of obstructive sleep apnea, history of psychiatric illness, pregnancy and presence of liver and renal diseases.
dose ranging study of the safety and efficacy of orally administered lyophilized fecal microbiota product (prim-dj2727) for the treatment of recurrent clostridium difficile infection (cdi)

Conditions: Recurrent C. Difficile Infection

Summary: to establish optimal dosing of lyophilized fecal microbiota transplantation (fmt) product in the treatment of recurrent c. difficile infection

this is a single center, randomized, parallel assignment, double-blinded, safety and efficacy study to be conducted in subjects with recurrent cdi. approximately 300 subjects will be enrolled in the study and randomized at 1:1:1 ratio to receive lyophilized donor intestinal bacteria with various doses in capsules. all subjects will be followed for approximately 180 days following fmt for safety.

Eligibility criteria:
inclusion criteria: * sexually active female subjects of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period * female subjects of child-bearing potential must have a negative pregnancy test on the day of the procedure. * subject willing to sign an informed consent form * subject deemed likely to survive for ≥ 1 year after enrollment * able to follow study procedure and follow-ups * subjects' attending physician will provide non-transplant care for the subject * diagnosed by medical history of ≥ 3 bouts of cdi in outpatients or ≥ 2 bouts of recurrent cdi in an inpatient with ≥ 2 positive fecal tests for c. difficile toxin * received at least one course of adequate antibiotic therapy for cdi (≥ 10 days of vancomycin or metronidazole or fidaxomicin) since last bout of cdi * have a 4 degrees celsius refrigerator at home to keep the second dose fmt for overnight exclusion criteria: * unable to take capsules orally * requiring systemic non-c. difficile antibiotic therapy within 14 days prior to fmt * actively taking saccharomyces boulardii or other probiotic at the time of fmt other than that found in fortified foods * need for continuing use of drugs with cdi activity: oral vancomycin, oral or iv metronidazole, fidaxomicin, rifaximin or nitazoxanide at the time of fmt and after fmt * severe underlying disease such that the patient is not expected to survive for one or more years or unstable medical condition requiring daily change in treatments
low-dose ketamine for acute pain in the emergency department

Conditions: Pain

Summary: this study aims to determine the efficacy and safety of low dose ketamine in association with iv morphine in the management of acute moderate to severe pain in emergency department. the investigators hypothesize that low dose ketamine will result in more effective pain control than morphine alone and will not be associated with an increase in adverse events.

management of pain in the emergency department is challenging. treatment of pain is most often accomplished by parenteral opioids analgesics. however, the use of opioids alone for pain control is often associated with inadequate analgesia and increased adverse events. low-dose ketamine has been shown to improve pain perception and produce an opioid-sparing effect when given perioperatively. its use in the ed may probably play a role in maximizing analgesia.

Eligibility criteria:
inclusion criteria: * able to understand and give informed consent * comfortable with the experimental protocol as outlined to them by the research team * severe pain, pain score of at least 50/100 on visual analogue scale (vas) or 5/10 numerical ratings score * acute pain, pain duration \< 7days * deemed by treating ed attending physician to require iv opioid analgesia exclusion criteria: * neurologic, respiratory, or hemodynamic compromise * pregnancy or breastfeeding * known or suspected allergy to ketamine or morphine * known renal (cr\>2.0) or liver failure * unstable psychiatric disease (as per treating physician) * history of stroke * history of cardiac disease or coronary artery disease * history of chronic respiratory disease

Keywords: pain ketamine morphine analgesia emergency