Kornimate/medical-research-clean huggingface dataset:
second line chemotherapy for s-1 refractory advanced gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is compare overall survival of the test arm (cpt-11/s-1 combination) to the control arm (cpt-11 alone) in the subjects with s-1 refractory advanced gastric cancer.

standard chemotherapy for advanced gastric cancer (agc) in the us is cisplatin/5-fu (cf) or docetaxel/cf (dcf), is in europe epirubicin/cf (ecf) or epirubicin/oxaliplatin/ capecitabine (eox). until 2006, there was no evidence of standard chemotherapy for agc in japan. in 2007, by the results of jcog9912 trial (5-fu alone vs. cpt-11/cddp vs s-1) and spirits trial (s-1 alone vs. s-1/cddp), s-1/cddp is regarded as a new standard regimen in japan. in 2008, by the results of top-002 trial (s-1 alone vs. s-1/cpt-11), s-1/cpt-11 could not show the superiority to s-1 alone. one of the other phase iii trials, jaccro gc-03 trial (s-1 alone vs. s-1/docetaxel, nct00287768) is now ongoing. however, the position of cpt-11 in the treatment of agc will be regarded as a second-line. in japan there is a controversy for the treatment of s-1 refractory gastric cancer. the controversy is continuing s-1 (like folfox to folfiri) or not as a second-line. after the successful adjuvant s-1 results (acts-gc trial), the same problem will occur in the patients who are recurrent from adjuvant s-1. then, we conducted a phase ii/iii trial of cpt-11 with or without s-1 in the treatment of first-line s-1 refractory agc.

Eligibility criteria:
inclusion criteria: * histologically proven inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) or relapse gastric adenocarcinoma * subjects must be able to take orally * subjects must be confirmed to be pd status by picture diagnosis after first-line chemotherapy using s-1 alone, s-1 + cisplatinum or s-1 + taxane, except s-1 + cpt-11 * within 4 weeks from the diagnosis of pd * total dosage of s-1 at the first-line is over 2,240mg/m2 in s-1 alone treatment, 1,680mg/m2 in the s-1 combination * ecog performance status ≤ 1 * follow up age 20 or over * life expectancy estimated more than 12 weeks * hgb ≥ 8 g/dl, wbc 4,000-12,000/mm3, anc ≥ 2,000/mm3, platelets ≥ 100,000/mm3 * creatinine ≤ upper normal limit (unl) * total bilirubin ≤ 1.5 x unl * written informed consent exclusion criteria: * s-1 + cpt-11 was employed as a first-line * any other cytotoxic agents therapy, immuno-therapy, radiation-therapy * after s-1 adjuvant * suspended cases by adverse events by s-1 or s-1 combination * excessive amounts of ascites require drainage * known brain metastases * history of hypersensitivity to fluoropyrimidines and cpt-11 * pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant * active double cancer * gastrointestinal bleeding * any subject judged by the investigator to be unfit for any reason to participate in the study

Keywords: stomach neoplasms second line chemotherapy refractory to s-1 irinotecan s-1 and irinotecan combination phase iii study
tracking service use and outcomes ii:first episode psychosis and psychotic disorders clinic

Conditions: Schizophreniform,First Episode Psychosis

Summary: main research questions: 1. who are the patients referred for treatment at the psychotic disorders clinic? 2. what are the outcomes from treatment for first episode psychosis in multiple outcome domains? 3. what hospital resources are used over the early course of the illness? 4. how satisfied are patients and family with the treatment and services they received? this is an important study that will help us evaluate the service and treatment offered by the psychotic disorders clinic's specialized early intervention program,which helps young people experiencing early stages of psychotic illness.a growing body of evidence suggests that intervening earlier in the course of the illness with specialized and complimentary pharmacological and psychosocial treatment may be associated with improved outcomes.

the project is primarily a descriptive study of individuals experiencing their first episode of psychosis presenting at the psychotic disorders clinic/early intervention program. the objectives of the study are: 1. track multi-dimensional outcomes within the program 2. track service use 3. compare outcomes for this early intervention program with outcomes noted in published follow up studies 4. evaluate effectiveness of the psychotic disorders clinic in improving outcomes for persons experiencing their first episode of psychosis

Eligibility criteria:
inclusion criteria: * male or female between ages of 16 to 50 years of age * capable of providing informed consent * receiving treatment voluntarily * experiencing a "first episode of psychosis" defined as the first episode of illness and where the subject,at presentation,meets dsm-iv criteria for one of the following diagnoses:schizophrenia,schizophreniform disorder,schizoaffective disorder,brief psychotic disorder,delusional disorder,and psychosis nos exclusion criteria: * primary diagnosis of mood disorder * diagnosis of substance-induced psychosis * diagnosis of psychosis due to a general medical condition * diagnosis of mental retardation * diagnosis of developmental disorder * has received antipsychotic treatment for greater than 1 month * has received treatment for an earlier episode of psychosis from which there has been a remission of symptoms for greater than 3 months

Keywords: early intervention,program evaluation
rizatriptan 10 mg rpd in the treatment of acute migraine

Conditions: Migraine

Summary: this is a multicentre, open label, prospective, randomized, two-attack study with active comparator in patients reporting inadequate response to analgesics and/or triptans to examine the efficacy of rizatriptan 10 mg rpd in this group of patients.


Eligibility criteria:
inclusion criteria: * patient's signature on the informed consent document \[each patient should be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the trial and have a clear understanding of the trial and the procedures involved prior to the signing of the consent form\]. * have a clinical diagnosis of migraine with or without aura according to ihs criteria at least one year prior to enrollment. * at screening at least two migraine attacks per month and no more than ten during the last three months prior to inclusion. * at screening a stable dose of prophylactic medication (including no prophylactic treatment) for at least two months and no change of prophylactic medication during active trial period. exclusion criteria: * contraindication to triptans or rizatriptan according to medical information sheet. * patient has a history or clinical evidence of ischemic heart disease (e.g., angina pectoris of any type, history of myocardial infarction or documented silent ischemia) or symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm (including prinzmetal's variant angina), or other significant underlying cardiovascular disease. patient has uncontrolled hypertension. patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to rizatriptan or any of its inactive ingredients. * history of treatment failure for at least one triptan for the treatment of acute migraine attacks. * any other headache, except tension type headache on 5 or less days a month within three months prior to screening. * a history of drug induced headache, medication overuse headache or any other addiction. * any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial. * females of childbearing potential not using reliable means of birth control, pregnant or lactating females or expected/ planned pregnancy. * participation (planned or current) in any investigational drug or device trial within the previous 30 days prior to screening visit. * inability to understand the trial procedures, and thus inability to give informed consent. * history of allergy to sulfa drugs.
hm2014-26 dt2219 for relapsed or refractory b-lineage leukemia or lymphoma

Conditions: Refractory B-Lineage Leukemia; Relapsed B-Lineage Leukemia; Refractory B-Lineage Lymphoma; Relapsed B-Lineage Lymphoma

Summary: this is a phase i/ii study of dt2219 for the treatment of relapsed or refractory cd19 (+) and/or cd 22 (+) b-lineage leukemia and lymphoma. the study consists of two phases - a phase i dose/schedule finding component using the maximum tolerated dose identified during the previous phase i study, but with a higher number of doses and a two-stage phase ii extension component to confirm safety and make a preliminary determination of the activity level by disease using the dose identified in phase i.


Eligibility criteria:
inclusion criteria: * histologic verification of b-cell lineage leukemia or b cell non-hodgkin lymphoma and evidence of relapse/refractory disease with the presence of cd19 and/or cd22 by flow cytometry or immunohistochemistry of bone marrow aspirate, peripheral blood or node/tumor biopsy * relapsed refractory disease that has failed conventional therapy and other therapies of higher priority * karnofsky performance status of ≥ 60% or, if less than 16 years of age, lansky play score of ≥ 60 (appendix ii) * recovered from effects of prior therapy * peripheral blast count under 50 x 10\^9/l * adequate organ function within 14 days (30 days for cardiac and pulmonary) of treatment start * women of childbearing potential and men should be advised and agree to practice effective methods of contraception during the course of study * voluntary written consent with appropriate parent/guardian consent and minor information sheet for participants \< 18 years of age exclusion criteria: * presence of leukemic or infectious pulmonary parenchymal disease * presence of active cns leukemia * presence of any uncontrolled systemic infection * documented uncontrolled seizure disorder- a seizure disorder controlled with medication * active neurologic disorder - peripheral neuropathy alone does not exclude a patient * active hepatitis b or hepatitis c (virus detectable by pcr) * documented penicillin or cephalosporin allergies * pregnant or lactating
diet/growth factor mechanisms of gut adaptation

Conditions: Short Bowel Syndrome

Summary: this is a double-blind randomized controlled study on the clinical and metabolic effects and underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition. clinical endpoints include ability to wean patients from parenteral feeding, metabolic endpoints include gut nutrient absorptive function and molecular endpoints include expression of growth factors and nutrient transporters in small bowel and colonic mucosa. the 6-month study is performed, in part, in the general clinical research center for inpatient stays and outpatient visits.

this is a double-blind randomized controlled study on the clinical and metabolic effects and underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition. clinical endpoints include ability to wean patients from parenteral feeding, metabolic endpoints include gut nutrient absorptive function and molecular endpoints include expression of growth factors and nutrient transporters in small bowel and colonic mucosa. the 6-month study is performed, in part, in the general clinical research center for inpatient stays and outpatient visits.

Eligibility criteria:
* parenteral nutrition-dependent adults with short gut syndrome. * patients must not have diabetes mellitus or active malignancy within the past 5 years.
us and mri of the forefoot: intermetatarsal bursitis or morton's neuroma

Conditions: Intermetatarsal Bursitis; Morton Neuroma; Intermetatarsal Neuroma

Summary: the aim of this study is to investigate the incidence of intermetatarsal bursitis and morton's neuroma in patients with metatarsalgia (i.e. pain in the forefoot) and control subjects by diagnostic imaging with ultrasound and mri.

in a group of patients with intermetatarsal pain found by an orthopedic surgeon, the investigators want to assess the incidences of intermetatarsal bursitis and morton's neuroma, using diagnostic imaging; ultrasound and mri. the hypothesis is, that intermetatarsal bursitis is an overlooked diagnosis in patients with metatarsalgia. as a result of sparse literature and lack of knowledge about this condition with symptoms mimicking morton's neuroma, a part of patients diagnosed with morton's neuroma, suffers from intermetatarsal bursitis instead. additionally, the investigators want to evaluate the clinical sign opening toes. based on clinical photos of the feet, the investigators want to document the presence of opening toes and investigate if there is a correlation with either intermetatarsal bursitis and/or morton's neuroma.

Eligibility criteria:
inclusion criteria: * age \> 18 years * pain in an intermetatarsal space (patient group) exclusion criteria: * age \<18 years * open wounds or ongoing infection in the forefoot at the time of examination * persons with contraindications to participate in mri scan * persons with a history of significant trauma in the forefoot, e.g. any fracture or previous surgeries in the forefoot * persons who have previously received treatment for morton's neuroma in the same foot, e.g. injection (within 6 months) or operation (anytime) * persons with severely impaired renal function (gfr \<30 ml/min) * persons with a systemic inflammatory condition like rheumatoid arthritis, due to clinically silent intermetatarsal bursitis in this group (control group)

Keywords: forefoot pain metatarsalgia
progesterone primed ovarian stimulation protocol versus antagonist protocol for pco patient

Conditions: Polycystic Ovary Syndrome; Infertility; IVF

Summary: this study is designed to compare the progesterone primed ovarian stimulation protocol versus the antagonist protocol as a method to stimulate pco patients in icsi cycles to decrease cost and decrease ohss.

a randomized controlled, non-blinded study (parallel-group study with 1:1 randomization) will be conducted at a specialized authorized ivf unit starting from january 2023 till completing the sample size. randomization will be generated by a computer and held with one of the experimenters, and (n) of the black and red cards will be used for allocation concealment. participants: all pco patients will be given informed consent about the study aims and written consent will be taken at the first visit to the infertility clinic of the specialized authorized ivf unit. patients will be categorized as (group a) progesterone primed ovarian stimulation protocol. (group b) conventional antagonist protocol.

Eligibility criteria:
inclusion criteria: - 1. pco patients based on rotterdam criteria (2003), including polycystic ovaries, oligo-anovulation, as well as the biochemical or clinical signs of hyperandrogenism (rotterdam et al, 2003). 2. age less than 40 years old. 3. primary infertility for 2 years and secondary infertility for 1 year. exclusion criteria: - non-pco patients as: * congenital adrenal hyperplasia * hyperprolactinemia. * recurrent implantation failure. * hydrosalpinx. * uterine pathology. * uncontrolled medical disorder eg dm, htn * male factor infertility.

Keywords: polycystic ovary disease icsi progesterone antagonist protocol
effect of two irrigation protocols applied prior to furcation repair

Conditions: Furcation Defects

Summary: perforations are mishaps that might occur during the course of endodontic treatment mainly due to iatrogenic factors. however, they might also occur due to extensive decay of dentinal structure. a perforation creates a pathological passage between the root canal system and the periodontium and jeopardizes the success of the endodontic therapy. the damage caused by the perforation may eventually result in the extraction of the compromised tooth

chitosan is the most abundant biopolymer on the earth derived from chitin. it shows a remarkable effective broad spectrum antibacterial action attributed to its cationic nature. it interacts with the -ve charged bacterial cell membranes, leading to leakage of the intracellular constituents and ultimately cell death due to increasing the membrane permeability. also, chitosan possesses a variety of other biological properties as being biodegradable, biocompatible and has chelating abilities, making it an interesting alternative to modern root canal irrigants. inadequacy of the repair materials has been a contributing factor to the poor outcome of repair procedures. on the basis of the recent physical and biologic property studies of the relatively new introduced mineral trioxide aggregate, this material may be suitable for closing the communication between the pulp chamber and the underlying periodontal tissues. there are few reports on repair of furcal perforation with mta in molar teeth. several studies have stated the ability of chitosan as a chelating agent that potentially enhance the dentin wettability. at the same time, chitosan nanoparticles showed the potential to stabilize dentine collagen by providing resistance to bacterial collagenase degradation. the null hypothesis: there is no difference in pain and healing between the two irrigation protocols of old fural perforations prior to application of bio c repair material.

Eligibility criteria:
inclusion criteria: * patients with old furcation perforation of mandibular molar. * size of perforation should be of average 1 to 2 mm. * period till treatment should be done within one month. * presence of polyp at the site of perforation is required in this study. exclusion criteria: * teeth in need for post retained restoration. * immunocompromised patients. * pregnant women and smokers. * patients with a history of antibiotic or analgesics intake within the few days before the intervention and cases with previously initiated endodontic treatment.
dect study in allopurinol-treated gout patients

Conditions: Gout

Summary: the purpose of this study is to determine presence and volume of monosodium urate (msu) crystal deposits as determined by dual-energy computed tomography (dect) imaging in gout subjects treated with allopurinol with and without visible tophi.

dect is a technique that enables visualization of msu crystal deposits by analysis of the chemical composition of the scanned materials. this study will determine the extent of msu crystal volume in the hands/wrists, feet/ankles, and knees as determined by dect of subjects with gout taking a dose of at least 300 mg allopurinol daily for the past 12 weeks. patients with gout on allopurinol with and without tophi to be assessed using dect imaging for crystal deposition with assessments, which include patient and provider assessments of disease severity and pain, prior to and after the scan.

Eligibility criteria:
inclusion criteria: * subject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity. * subject is willing to adhere to the visit/protocol schedules. * subject meets the diagnosis of gout as per the american rheumatism association criteria for the classification of acute arthritis of primary gout. * subject has been taking allopurinol at a dose of at least 300 mg daily for at least 12 weeks prior to day 1, as the sole uratelowering therapy. exclusion criteria: * subject who is pregnant or breastfeeding. * subject with any other medical or psychological condition, which in the opinion of the investigator and/or medical monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements (including dual energy computed tomography imaging), or to complete the study. * subject who has received an investigational therapy or has participated in any clinical trial or research study within 30 days of day 1. * subject who has taken pegloticase (krystexxa®) or is expected to take pegloticase during the study.
comparison of two multifocal contact lenses worn on a daily disposable basis

Conditions: Presbyopia; Myopia

Summary: the purpose of this trial is to evaluate and compare the clinical performance of two multifocal contact lenses.


Eligibility criteria:
inclusion criteria: * age 41 to 68 (inclusive). * spectacle add between +0.75 and +2.75d (inclusive). * habitual spectacle prescription ≤ 1.00dc (cyl). * other protocol-defined inclusion criteria may apply. exclusion criteria: * eye injury or surgery within twelve weeks of enrollment. * pre-existing ocular irritation that would preclude contact lens fitting. * currently enrolled in a clinical trial. * prior refractive surgery. * other protocol-defined exclusion criteria may apply.
survey and blood sample collection for patients with lung cancer who never smoked cigarettes

Conditions: Lung Cancer

Summary: the purpose of this study is to determine if collecting information and blood from a group of people who never smoked but who have lung cancer, is possible across the us. the investigators will collect information on each patient's diagnosis and treatments. if the collection is successful, blood samples will be used to try to identify new genes (which are the basic elements of heredity, passed from parents to their offspring), which may explain and predict why certain patients develop lung cancer without having smoked tobacco.


Eligibility criteria:
inclusion criteria: * 18 years or older * histologically and/or cytologically proven diagnosis of non-small cell lung cancer * never smoker, defined as having smoked less than 100 cigarettes over one's life-time * completed survey and inclusion form * signed informed consent exclusion criteria: * previous history of cancer (other than lung cancer) * living outside the united states * patients who cannot read english (as website and questionnaires will only be written in english) * unable to understand the protocol or to give informed consent

Keywords: questionaires