Kornimate/medical-research-clean huggingface dataset:
maintenance interpersonal psychotherapy for sustaining remission of depression

Conditions: Depression

Summary: this study will evaluate the effectiveness of maintenance interpersonal psychotherapy (ipt) in preventing relapse of depression in women who have required combined psychotherapy and pharmacotherapy treatment to obtain a remission of depression symptoms.

depression is a serious medical illness that can recur more than once in a person's lifetime. effective treatment methods are needed to maintain a state of remission in people who have had prior episodes of depression. ipt is a brief and highly structured type of psychotherapy that addresses interpersonal issues associated with depression. previous studies have shown that it is an effective method for treating depression. this study will evaluate the effectiveness of maintenance itp in preventing relapse of depression in women who have required combined psychotherapy and pharmacotherapy treatment to obtain remission of depressive symptoms. participants in this open label study will be recruited from a previous study, "maintenance psychotherapy in recurrent depression: study i." in this study participants will initially receive weekly sessions of ipt as well as medication treatment with fluoxetine. any participants who do not reach remission of depressive symptoms after 6 weeks will be given other standard treatments for depression. once remission of depressive symptoms is reached, participants will continue receiving weekly ipt and fluoxetine treatment for 20 weeks. after 20 weeks, fluoxetine treatment will be discontinued, and all participants will receive ipt alone for 6 weeks before entering the maintenance phase of the study. upon entrance into this phase, participants will be randomly assigned to receive ipt weekly, biweekly, or monthly for 18 months. functioning and depressive symptoms will be assessed at month 24.

Eligibility criteria:
inclusion criteria: * met all entry criteria for the parent study, "maintenance psychotherapy in recurrent depression, study i" * began ipt as outlined in the parent study * demostrated compliance with ipt sessions during the parent study * exhibits less than a 50% reduction in score on the hamilton rating scale for depression after 12 weeks of psychotherapy or fails to meet stabilization criteria after 24 weeks of psychotherapy during the parent study exclusion criteria: * any unstable medical illness

Keywords: depression relapse maintenance therapy
gpnmb-targeting chimeric antigen receptor t-cell therapy (gcar1) for a patient with alveolar soft part sarcoma (clic-yyc-gpnmb-02)

Conditions: Alveolar Soft Part Sarcoma

Summary: clic-yyc-gpnmb-02 is a single patient study (sps) developed according to the health canada template and guidelines released in 2019 for studies to access therapies not otherwise available to patients, in the situation where there are no options of treatment or cure remaining. the patient under consideration for clic-yyc-gpnmb-02 has progressive metastatic alveolar soft part sarcoma (asps). we propose to treat the patient with gcar1, a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (car) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic b (gpnmb).


Eligibility criteria:
inclusion criteria: * completion of informed consent form * adequate organ function, defined as creatinine clearance \>30 ml/min and lvef \>45%. exclusion criteria: * any active uncontrolled infection, pregnancy or nursing.
ovarian reserve and ankylosing spondylitis

Conditions: Ovarian Diseases; Ankylosing Spondylitis; Anti-Mullerian Hormone Deficiency

Summary: the aim of this study was to determine the status of ovarian reserve in patients with ankylosing spondylitis (as) using anti-mullerian hormone (amh) level and antral follicle count (afc). women with as and women controls diagnosed according to the classification criteria proposed by the american-european consensus group will be included in the study. ovarian reserve will be evaluated in terms of clinical findings, afc and serum amh and reproductive hormone levels. researchers predict that the ovarian reserve may be reduced in patients with as due to the autoimmune process and the pathophysiology of the disease. serum amh and ovarian afc may be useful for assessing ovarian reserve. it is aimed to determine the course of ovarian reserve abnormalities and the best possible biomarkers of reduced ovarian reserve in patients with as.


Eligibility criteria:
inclusion criteria: * regular menstruation with intervals of 21-35 days; * cycle length variations \<4 days; * both ovaries still present exclusion criteria: * history of liver failure; * diagnosed malignancy; * cigarette smoking; * chronic renal failure; * known infertility; * presence of gynecological abnormalities such as abnormal uterine bleeding or menorrhagia; * history of ovarian surgery; * history of hormone preparation (including corticosteroids) use or use of herbal products within 3 months; * diagnosis of polycystic ovary syndrome.

Keywords: ankylosing spondylitis fertility anti-müllerian hormone ovarian reserve
the colorado leap study: a socioecological approach to obesity prevention in early childhood

Conditions: Childhood Obesity

Summary: the colorado longitudinal eating and physical activity (leap) study utilizes a social ecological approach to explore individual, family and environmental factors and their relationship to child weight status over a 3 year timeframe. our primary research questions are as follows: 1. are behavior changes (increased willingness to try new foods and gross motor skills) from a preschool nutrition and activity program, the food friends®, sustained through early elementary school? 2. do the food friends® programs have an impact on reducing the percentage of children considered overweight and/or obese over a 3 year timeframe? 3. do food preference and gross motor performance directly affect child weight status or are they mediators to dietary intake and physical activity?

the preschool years are a critical time to begin obesity prevention efforts as they represent a time when young children establish healthy eating habits and physical activity patterns. these habits can place children at risk for obesity and are shaped by many characteristics, including individual characteristics as well as school, family and societal environmental characteristics. predictive behaviors, or behavioral antecedents, within these environments can influence child behaviors. while many predictive behaviors have been shown to influence dietary intake, physical activity, and weight status, two potential behavioral antecedents - food preference and motor performance - need further exploration. understanding the context in which child behavioral patterns are developed is critical to developing a model to address childhood obesity. the colorado leap project is a longitudinal cohort study utilizing a controlled quasi-experimental design in 5 rural colorado communities. two communities serve as intervention communities with the other 3 as matched controls. intervention sites receive the food friends® nutrition and physical activity programs in preschool and 'booster' programming in kindergarten and 1st grade. assessments are administered 4 times - twice in preschool (fall and spring) and once in both kindergarten and 1st grade (spring). observational measures with children are conducted at the school; parent/home measures are sent home and returned to school via the child; and school personnel complete school environment and policy assessments.

Eligibility criteria:
inclusion criteria: * children enrolled in participating schools; entering kindergarten the year after recruitment exclusion criteria: * children not entering kindergarten within one year of recruitment.

Keywords: child, preschool parents family obesity overweight diet overnutrition motor activity child care schools
predicting the outcome of total knee arthroplasty and spinal surgeon

Conditions: Osteoarthritis;; Intervertebral Disc Degeneration

Summary: the purpose of this observational study is to investigate the preoperative and operative factor of pain and functional outcome at one years following total knee arthroplasty and spinal surgeon.


Eligibility criteria:
inclusion criteria: 1. the patients have been waiting for surgery for treatment of osteoarthritis or disc degeneration disease. 2. must be between 18 and 65 years of age, of either sex. 3. must demonstrate willingness to participate in the study by signing the written informed consent. exclusion criteria: 1. patients with mandatory spondylitis, infections, neoplasms, inflammation, deformities, or previous surgery of spine or knee. 2. the patient is participating in an interventional clinical trial or has in an interventional clinical trial within 30 days prior to enrollment.
decitabine versus supportive care in adults with advanced-stage mds

Conditions: Myelodysplastic Syndrome

Summary: to compare the safety and efficacy profiles of decitabine to those of supportive care in adults with advanced-stage myelodysplastic syndrome (mds)

this experimental (investigational) study is intended to answer the question of whether decitabine is any better than supportive care alone in delaying progression (worsening) of the disease, prolonging survival or improving the overall quality of life for mds patients who are not candidates for bone marrow transplant (bmt).

Eligibility criteria:
inclusion: * mds (de novo or secondary) fitting any of the recognized french-american-british, fab, classifications or chronic myelomonocytic leukemia (cmml) with wbc \ /= 0.5 as determined by cbc, bone marrow assessment and bone marrow cytogenetics within 30 days of randomization * 18 years or older * female patients of child-bearing potential must have a negative serum hcg within 24 hours prior to randomization, must practice a medically approved method of birth control for the past 30 days, and agree to continue this practice for the trial duration and must not be breast-feeding * ecog or who performance status of 0-2 * written informed consent * normal renal and hepatic function (creatinine \</= 2 mg/dl, bilirubin \</= 1.5 mg/dl, sgpt \</= 2 times the upper limit of normal range) exclusion: * acute myeloid leukemia (aml) (\>/=30% bone marrow blasts) or other progressive malignant disease * patients must have recovered from the toxic effects of prior therapy and must be off all chemotherapy for a minimum of 4 weeks prior to study entry to the protocol (a minimum of six weeks for prior nitrosoureas and bone marrow transplantation) * ongoing treatment with androgenic hormones, danazol, colony-stimulating factors, or other agents used to treat mds within 7 days of study initiation. * administration of any investigational agent within the 30 days preceding study initiation. * uncontrolled cardiac disease or congestive heart failure * uncontrolled restrictive or obstructive pulmonary disease * active viral or bacterial infection * superimposed autoimmune hemolytic anemia or thrombocytopenia * known positive serology for hiv * mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study.

Keywords: myelodysplastic syndrome mds chronic myelomonocytic leukemia cmml decitabine 5-aza-2'deoxycytidine
c1 esterase inhibitor in hereditary angioedema (hae)(extension study)

Conditions: Hereditary Angioedema

Summary: hereditary angioedema (hae) is a rare disorder characterized by congenital lack of functional c1 esterase inhibitor. if not treated adequately, the acute attacks of hae can be life-threatening and may even result in fatalities, especially in case of involvement of the larynx.the planned extension study is designed to enrol subjects that participated in the pivotal study in order to provide them with c1-inh for treatment of acute hae attacks for 24 months or until the licensing procedure for c1-inh is finalized, whatever comes first.


Eligibility criteria:
key inclusion criteria: * documented congenital c1-inh deficiency * acute hae attack * participation in base study ce1145_3001 (nct00168103) key exclusion criteria: * acquired angioedema * treatment with any other investigational drug besides ce1145 in the last 30 days before study entry

Keywords: c1 inhibitor hereditary angioedema acute hae attack
evaluation of dr-2001 for the management of endometriosis-related pelvic pain

Conditions: Endometriosis

Summary: this is a 3-arm, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of dr-2001 in endometriosis-related symptoms, primarily nonmenstrual pelvic pain, over a 12-week treatment period.

this multicenter, double-blind, randomized, placebo-controlled study is designed to evaluate the ability of dr-2001 to produce beneficial changes in endometriosis-related symptoms, primarily nonmenstrual pelvic pain, over a 12-week treatment period. the overall study duration for each patient will be about 20 weeks. patients who meet all study entrance criteria will be randomly assigned to one of three treatment groups. the change in endometriosis-related clinical symptoms will be assessed in two ways: through a combined physician/patient assessment and also with a patient self-assessment. patients will undergo a gynecologic exam at each study visit.

Eligibility criteria:
inclusion criteria: * surgically sterilized (patient or partner), willing to use condoms throughout the study, or otherwise not at risk for pregnancy * diagnosis of endometriosis within the last 5 years * moderate or severe nonmenstrual pelvic pain * premenopausal * not pregnant or breastfeeding * regular (24-35 day) menstrual cycles for at least 2 months exclusion criteria: * undiagnosed abnormal genital bleeding * any contraindication to the use of hormonal therapy * prior surgery for endometriosis * gnrh analog therapy within 5 months * use of estrogens and/or progestins within 2 months * pain symptoms unrelated to endometriosis * any contraindication to the use of vaginal delivery systems

Keywords: endometriosis pelvic pain hormonal treatment
one-stage exchange for chronically infected total hip arthroplasty

Conditions: Infection

Summary: the primary goal of the study is to evaluate the success rate of routine one-stage exchange for treatment of chronically infected total hip arthroplasty performed at the investigators institution, and to compare it to the current literature reporting success rate of selected one-stage exchange procedure or two-stage procedure. the secondary goal is to detect the potential prognostic factors and potential selection criteria which may influence the success rate. the tested hypothesis is following: the success rate of routine one-stage exchange is lower than that of selected one-stage or two-stage procedure


Eligibility criteria:
inclusion criteria: * chronically infected total hip arthroplasty * one-stage exchange procedure operated on at the investigators institution between january 1, 2007 and november 30, 2010 exclusion criteria: * patient refused to participate

Keywords: arthroplasty hip
impact of microparticles on postoperative complications in surgical patients

Conditions: Neoplasm, Hepatic; Pancreatic Neoplasms; Colorectal Neoplasms

Summary: microparticles are cellular fragments which are released actively or passively under conditions of inflammation and stress. the impact of surgical operations on quantity and quality of microparticles remains unknown. in this observatory study we investigate quantitative and qualitative aspects of microparticles during cardiac and abdominal operations.


Eligibility criteria:
inclusion criteria: * patients undergoing cardiac or abdominal operations with a minimum expected operative time of 2 hours exclusion criteria: * laparoscopic operations * emergency operations
prospective cohort study of rapid response team

Conditions: Hospital Medical Emergency Team; Medicine, Emergency; Hospital Rapid Response Team

Summary: the purpose of this study is to collect data of rapid response team activated patients prospectively

acutely deteriorating patients including sudden cardiac arrest in general ward who are monitored and intervened by rapid response team

Eligibility criteria:
inclusion criteria: - patients admitted to general ward in seoul national university bundang hospital and monitored by in-hospital rapid response system. exclusion criteria: * patients admitted to pediatric wards * patients in emergency room, intensive care unit, and operating room
impact of fdg-pet/ct on management of patients with native valve infective endocarditis

Conditions: Infective Endocarditis; Native Valve Endocarditis

Summary: the proposed study is a multicentric prospective observational cohort study of patients with suspected nve. the study population includes those with possible ie according to the modified duke criteria and investigated at one of the 6 participating sites which include 2 cardiac centers, the mhi and the iucpq, as well as 4 tertiary care centers, the jewish general hospital , the mcgill university health centre and the chus.


Eligibility criteria:
inclusion criteria: * 18 years of age or older, capable to provide informed consent; * referred for a fdg-pet/ct study * classified as having possible ie prior to fdg-pet/ct imaging; * patients must be able to tolerate the physical/logistical requirements of a pet/ct scan. exclusion criteria: * subjects with prosthetic cardiac valve and/or cied; * pregnant or breastfeeding female; * body mass index \> 45 kg/m2.

Keywords: pet/ct fdg duke criteria
adrenomedullin and outcome in severe sepsis and septic shock

Conditions: Severe Sepsis; Septic Shock

Summary: the aim of this prospective study is to assess the prognostic value of bioactive plasma adrenomedullin (adm) in 600 patients with severe sepsis or septic shock in an international multicenter study and to validate the findings concerning the association of adm concentration and the use of vasopressor therapy, organ failure and outcome.

sepsis involves an overactive inflammatory response to severe bacterial infection that can compromise vascular integrity and cause tissue edema, organ dysfunction and death. adrenomedullin (adm) has attracted the interest of researchers because of its powerful physiological functions. an anti-adm antibody reduced the norepinephrine infusion rates required to achieve hemodynamic targets, increased urine flow and improved creatinine clearance, which ultimately resulted in attenuated systemic inflammation and tissue apoptosis, during resuscitated cecal ligation and puncture (clp)-induced septic shock in mice. in humans, plasma adm has been determined only in a small number of sepsis patients, and - except from one study - the assays used did not selectively measure the bioactive adm form and have been considered not reliable. therefore, the potential value of determining plasma adm in such patients cannot yet be ascertained and the optimal cut off needs to be validated in future studies

Eligibility criteria:
inclusion criteria: * age \>18 years * patients admitted in intensive care unit for severe sepsis or septic shock according to international, standardized criteria,transferred from another intensive care unit less than 24 hours after the primary admission, or being treated with vasopressors for less than 24 hours in the prior icu * signed consent form exclusion criteria: * age \< 18 years * severe sepsis or septic shock patients transferred from another intensive care unit later than 24 hours after the primary admission or being treated with vasopressors for more than 24 hours in the prior icu * pregnant women * vegetative coma * participation in an interventional clinical trial in the preceding month

Keywords: severe sepsis septic shock adrenomedullin organ dysfunction
phase i study of a selective alk inhibitor plb1003 in patients with alk+ nsclc.

Conditions: Non-Small Cell Lung Cancer

Summary: this phase i, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (mtd), recommended phase ii dose (rp2d), dose-limiting toxicities (dlts), pharmacokinetics (pk) profile, and preliminary antitumor activity of plb1003.

this is a phase i, open-label study of pb1003 administered orally to patients with alk-positive (alk+) advanced nsclc. the study includes a dose-escalation part (part a) and a dose expansion part (part b). the aim of the part a is to estimate the mtd and to identify the dose limited toxicity(dlt) and the recommended phase ii dose (rp2d) for plb1003 single agent as well as to determine the pk/pd profile. once response has been observed in certain dose level, then followed by the expansion part to further assess the clinical efficacy and safety of plb1003 single agent. aprox 40 patients will be enrolled in part a, while 12-24 patients for expansion cohort . plb1003 is a potent selective alk inhibitor. plb1003 acts on cancer by blocking abnormal alk-mediated signaling, leading to profound tumour growth inhibition in xenografts of non-small cell lung cancer (nsclc) tumours.

Eligibility criteria:
inclusion criteria: * signed informed consent form * age≥18 years * diagnosed with a locally advanced or metastatic non-small cell lung cancer that has progressed despite standard therapy. * must have evidence of alk positivity from the results of molecular pre-screening evaluations * at least one measurable lesion as per recist v1.1 * patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 * ecog performance status of 0-2 exclusion criteria: * symptomatic central nervous system (cns) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any cns deficits. * clinically significant, uncontrolled heart diseases. unstable angina. history of documented congestive heart failure (new york heart association functional classification iii-iv) . * active peptic ulcer disease or gastritis * major surgery within 4 weeks prior to starting plb1003 * previous anti-cancer and investigational agents within 4 weeks before first dose of plb1003.. * pregnant or nursing women * involved in other clinical trials \< 30 days prior to day 1