Kornimate/medical-research-clean huggingface dataset:
piritrexim in treating patients with advanced cancer of the urinary tract

Conditions: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of piritrexim in treating patients with advanced cancer of the urinary tract that has not responded to previous treatment.

objectives: i. evaluate the antineoplastic activity of piritrexim and its effect on the survival of patients with advanced urothelial carcinoma previously treated with systemic cytotoxic chemotherapy. ii. evaluate the toxicity of piritrexim in these patients. outline: patients receive piritrexim by mouth 3 times daily, 5 days a week, for 3 weeks followed by 1 week of rest. patients with responding or stable disease continue treatment every 4 weeks until unacceptable toxicity or progression intervenes. projected accrual: a maximum of 40 patients will be entered over 5-6 months if at least 1 response is observed in the first 14 evaluable patients.

Eligibility criteria:
disease characteristics: histologically confirmed transitional cell carcinoma, squamous cell, or adenocarcinoma of the renal pelvis, ureter, bladder, or urethra progressing regional or metastatic disease after one prior systemic or intra- arterial chemotherapy regimen bidimensionally measurable disease, e. g.: pulmonary nodules palpable lymph nodes cutaneous or subcutaneous nodules mediastinal tumor or hepatic metastases if clearly measurable on ct no prior radiotherapy to indicator lesion unless documented progression since completion of radiotherapy patient characteristics: age: 18 and over performance status: ecog 0 or 1 hematopoietic: (within 2 weeks prior to entry) wbc at least 4,000/mm3 platelet count at least 100,000/mm3 hepatic: (within 2 weeks prior to entry) bilirubin no greater than 2.0 mg/dl ast no greater than twice normal renal: (within 2 weeks prior to entry) creatinine no greater than 1.5 mg/dl or creatinine clearance greater than 40 ml/min other: no active unresolved infection no concurrent parenteral antibiotics at least 7 days since parenteral antibiotics no history of prior malignancy within 5 years except: curatively treated nonmelanomatous skin cancer in situ cancer of the cervix not pregnant or nursing adequate contraception required of fertile patients physically and medically able to take oral medications prior concurrent therapy: biologic therapy: one prior systemic biological response modifier therapy allowed at least 3 weeks since biologic response modifier therapy and recovered chemotherapy: see disease characteristics at least 3 weeks since chemotherapy and recovered endocrine therapy: not specified radiotherapy: at least 4 weeks since radiotherapy surgery: at least 3 weeks since major surgery and recovered

Keywords: recurrent bladder cancer transitional cell carcinoma of the bladder squamous cell carcinoma of the bladder adenocarcinoma of the bladder recurrent urethral cancer recurrent transitional cell cancer of the renal pelvis and ureter
use of oral contraceptives (ocs) containing dienogest and risk of venous thromboembolism

Conditions: Venous Thromboembolism

Summary: the objective of this study is to compare the risk of venous thromboembolism (vte) of oral contraceptives with non-use, focusing specifically on valette® compared to other users of low estrogen dose combined oral contraceptives.

this is a population-based case-control study in germany. cases are women who are between 15 and 49 years old with a diagnosis of venous thromboembolism (vte). the vte is diagnosed in germany between january 2002 und december 2007. controls are women who are between 15 and 49 years old without a vte diagnosis. about 4 controls matched by year of birth and region will be allocated to each case. both cases and controls will receive a similar self-administered questionnaire except of some case-specific questions which are not applicable for the controls. study participants will be asked for their informed consent. data confidentiality will be ensured by the berlin center for epidemiology and health research.

Eligibility criteria:
inclusion criteria: * cases: women with a venous thromboembolism who are between 15 and 49 years old * control: women without a venous thromboembolism diagnosis who are between 15 and 49 years old exclusion criteria: * women outside the defined age range * women with severe language problems * women who are not willing to participate

Keywords: venous thromboembolism
comparison of sternal wound infiltration with liposomal bupivacaine v. bupivacaine hydrochloride

Conditions: Coronary Artery Disease; Coronary Artery Stenoses; Valve Regurgitation, Mitral; Valve Regurgitation, Tricuspid

Summary: the aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (lb) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (cpb) and compare it with bupivacaine hydrochloride infiltration

there are no studies to date on the use of lb infiltration and its analgesic efficacy in cardiac surgery done through sternotomy, even though the majority of cardiac surgeries utilize this approach. moderate to severe pain is common in patients undergoing these surgeries and is usually inadequately treated. other various pain treatment modalities such as opioid and neuraxial anesthesia are avoided due to potentially dangerous side effects in this cohort. the efficacy of local anesthesia techniques, such as bupivacaine, are limited due to short duration of action and increased incidence of wound infection. on the other hand, slow release liposomal bupivacaine may last up to 72 hours, indicating it's potential for more adequate analgesia compared to bupivacaine.

Eligibility criteria:
inclusion criteria: * open cardiac surgery through sternotomy approach (eg. coronary artery bypass graft, valvular heart procedures, as well as other open cardiac procedures along with coronary artery bypass) * surgery with the use of cardiopulmonary bypass exclusion criteria: * minimally invasive heart surgery through thoracotomy approach * patient undergoing procedures under deep hypothermic circulatory arrest * patients with active infections such as infective endocarditis * emergency surgery * patients undergoing transplantations and ventricular assist device insertion * patients on any mechanical circulatory support preoperatively * patient's refusal * end stage liver or renal disease * allergy to bupivacaine * patient who cannot understand the study procedure or refuse to participate * redo-sternotomy * participation in another study * patients with severe right or left ventricular dysfunction (ef\< 25%) * patients requiring chronic opioids for chronic pain condition

Keywords: cardiac surgery sternotomy post-operative pain sternal wound infiltration
an open label study in healthy volunteers to compare chronocort® to hydrocortisone

Conditions: Congenital Adrenal Hyperplasia; Adrenal Insufficiency

Summary: this was an open label, randomized, single dose, three period crossover pharmacokinetic study of chronocort® in 30 healthy male volunteers. the study was conducted in smaller sub groups (group 1, n=18 and group 2, n=12).


Eligibility criteria:
inclusion criteria: * healthy male volunteers between 18 and 60 years of age, inclusive (at screening). * subjects with a body mass index (bmi) of 21-28. body mass index = body weight (kg) / (height (m))2. * subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days of the start of the study. the parameters measured included those shown in appendix 3 of the study protocol. * subjects with a negative urinary drugs of abuse screen (including alcohol), determined within 14 days of the start of the study. * subjects with negative hiv and hepatitis b and c results. * subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ecg) determined within 14 days of the start of the study. * subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements. * subjects and sexual partners must have used effective contraception methods during the trial and for 3 months after the last dose, for example: * oral contraceptive + condom * intra-uterine device (iud) + condom * diaphragm with spermacide + condom * subjects must have been available to complete the study. * subjects must have satisfied a medical examiner about their fitness to participate in the study. * subjects must have provided written informed consent to participate in the study. exclusion criteria: * a clinically significant history of gastrointestinal disorder likely to influence drug absorption. * receipt of regular medication within 14 days of the first study day (including high dose vitamins, dietary supplements or herbal remedies). * evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction. * a clinically significant history of previous allergy / sensitivity to hydrocortisone. * a clinically significant history of drug or alcohol abuse. * inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function). * participation in a new chemical entity clinical study within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks. * subjects who had consumed more than 2 units of alcohol per day within seven (7) days prior to the first dose or had consumed any alcohol within the 48 hour period prior to the first dose. * donation of 450ml or more blood within the previous 12 weeks. * subjects who worked shifts (i.e. regularly alternated between days, afternoons and nights).
predictive factors of ptsd in adults admitted to an emergency service

Conditions: Post Traumatic Stress Disorder; Psychiatric Issue

Summary: after trauma or stress factor like death exposition, serious injuries or sexual violence, some patients may develop stress reaction characterized by the presence of various symptoms among different categories (reviviscence, negative humor, dissociates symptoms, occasion, hypervigilance). in the month following trauma, the investigators speak of acute stress reaction (asr) when symptoms are present during at least three days. if symptoms are present one month after trauma, then it is a post-traumatic stress disorder (ptsd). among patients visiting emergency after latest trauma, quite a few is in acute stress reaction. however, this reaction is often incorrectly identified by healthcare team, due to lack of oriented medical examination, patients visiting about other complaints (pain, insomnia) and not expressing clearly the trauma context. yet, it is know that acute stress reaction occurrence and existence of dissociate symptoms after trauma confrontation is considerably predictive of the eventual post-traumatic stress disorder occurrence. the identification of risk population of post-traumatic stress disorder is not the subject of any particular structured procedure in emergency services while early care of these patients may allow limiting post-traumatic stress disorder occurrence and associate consequences. previous works on the subject having exclusively targeted some trauma subgroups or some predictive factors subtypes, investigators propose here biopsychosocial global approach that can weight the impact of each parameters. in this study, investigators aim at determining predictive biopsychosocial factors of the post-traumatic stress disorder occurrence at 3 months in patients visiting emergency after latest trauma (less than one month old) and identified as "high-risk" to develop post-traumatic stress disorder (moderate or high).


Eligibility criteria:
inclusion criteria: * man or woman aged between 18 and 70 * admitted in an emergency service after a trauma less than one month old, defined by death exposition or death threat, serious injury or sexual violence, by one or several of the following; * being directly exposed ; * being direct witness of traumatic event that occurred to other people; * hearing that traumatic event arrived to close family member or close friend. in the case of death penalty or death threat of a family member or a friend, events must have been violent or accidental. * being exposed repeatedly or extremely to aversive characteristics of trauma events (for example: first line actors gathering human remains, cops exposed several times to kid sexual abuse explicit fact). * written informed-consent * affiliation to the french social security scheme or beneficiary of a similar scheme exclusion criteria: * patient not understanding french language * patient under guardianship * clinical instability making impossible the realization of questionnaires (for example: agitation, vital risk, disorders of consciousness...)
exercise program to improve balance in hemophilic patients

Conditions: Haemophilia

Summary: this study evaluates the effectiveness of a program of physiotherapy exercises to train the balance and dual task in adults patients with hemophilia

the objective of the study is to create an exercise program to improve the static and dynamic balance in hemophilic patient. in addition, the effect of the exercise program on dual task, functionality, proprioception, qol, risk of falls and the kinesiophobia will be analyzed.

Eligibility criteria:
inclusion criteria: * diagnosis of haemophilia a or b * willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations * approval by their hematologist to participate in the exercise program * with hemostatic coverage supervised by your hematologist. * age between 18 and 60 years * informed consent signed. exclusion criteria: * non adherence to instruction on proper exercise technique * surgical procedures performed 6 months prior to or during the exercise program * a major bleeding episode that posed a risk or prevented exercise * need for major surgery * suffer from dizziness * withdrawal of informed consent * acquired hemophilia
phenolic-rich oats and artery improvement

Conditions: Healthy

Summary: in this proposed human trial, the investigators aim to establish whether consumption of one portion of phenolic acid-rich oats leads to acute improvements (i.e. 1-24h post-intake) in markers of cardiovascular disease risk relative to an energy matched control intervention in healthy men with high-normal to mildly elevated blood pressure.

a diet rich in whole grain is inversely associated with cardiovascular disease risk. whole grains contain a wide range dietary components including potentially vasoactive phenolic acids.

Eligibility criteria:
inclusion criteria: * above average blood pressure (i.e. systolic 120-159 mmhg and diastolic 75-99 mmhg) exclusion criteria: * abnormal biochemical, haematological results as assessed at health screening * hypertension (i.e. systolic/diastolic blood pressure ≥160/100 mm hg) bmi \>35 * current smoker or ex-smoker ceasing \<3 months ago * past or existing medical history of vascular disease, diabetes, hepatic, renal, gastrointestinal, haematological, neurological, thyroidal disease or cancer * prescribed or taking lipid lowering, antihypertensive, vasoactive (e.g. viagra), anti-inflammatory, antibiotic or antidepressant medication * allergies to whole grains * parallel participation in another research project * having flu vaccination or antibiotics within 3 months of trial start * on a weight reduction regime or taking food supplements within 3 months of trial start * performing high level of physical activity (i.e. \>3 x 20 min aerobic exercise/week) * consumption of ≥21 units of alcohol/week * small veins not allowing cannulation

Keywords: oats phenolic acid fmd ldi avenanthramide
which factors are relevant for treatment outcome in dialectical behaviour therapy for borderline personality disorder?

Conditions: Borderline Personality Disorder; Non-suicidal Self-injury; Deliberate Self Harm

Summary: the objective of this project is to investigate factors that contribute to the success and lack of success in dbt among individuals with bpd and a history of self-harm in a clinical psychiatric setting. 1. do certain personality factors and identity disturbance predict the treatment outcome of dbt in individuals with bpd? 2. do changes in identity disturbance, self-hate, or emotion regulation mediate the treatment outcome of dbt in individuals with bpd? 3. do specific personality profiles moderate the treatment outcomes of dbt for individuals with bpd? 4. when does the primary treatment effect occur, and does this effect persist after a 12-month follow-up period?

borderline personality disorder (bpd) is a complex and enduring mental health condition characterized by a range of symptoms. the consequences of bpd are severe, causing individual suffering, impairments in daily functioning, and increased mortality rates. dialectical behavior therapy (dbt) is one of the most widely used treatment models for bpd and self-harm. dbt has demonstrated positive outcomes but not all individuals benefit equally from this therapy, highlighting the need for further exploration. specifically, there is a knowledge gap regarding what predicts positive treatment response. research exploring this topic, has highlighted the potential significance of emotion regulation, personality profiles, self-concept, and identity disturbance in understanding the outcomes of individuals with bpd. the primary objective of this research project is to investigate the factors that contribute to the success and lack of success in dbt. all individuals referred to dbt-treatment in the adult psychiatric clinic in lund will be offered participation in the study. all study participants receive the same treatment as those who chose not to participate. measures will commence after treatment contracts have been negotiated and the treatment will continue up to a maximum treatment length of one year. data will be retrieved from databases, medical records as well as collected as self-report forms. self-report measures will be conducted every three months, at end of treatment and at follow up 12 months after end of treatment. data from registries and charts will be collected at time of consent and at follow up 12 months after treatment.

Eligibility criteria:
inclusion criteria: * borderline personality disorder as defined by the dsm-v (assessed with scid or uquivalent). * self-harm over the past 12 months * offered dbt at the lund adult psychiatric clinic exclusion criteria: * unable to read or communicate in swedish

Keywords: borderline personality disorder dialectical behavior therapy deliberate self-harm non-suicidal self-injury self-concept personality
safety, pharmacodynamics, pharmacokinetics, and efficacy of gs-9901 in adults with relapsed or refractory follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma

Conditions: Follicular Lymphoma; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma

Summary: this study will evaluate the safety and tolerability of gs-9901 monotherapy in adults with follicular lymphoma (fl), marginal zone lymphoma (mzl), chronic lymphocytic leukemia (cll), or small lymphocytic lymphoma (sll). the study will also characterize the pharmacokinetic (pk) profile of gs-9901, determine the appropriate dosing regimen of gs-9901 for use in future clinical trials, and to evaluate the efficacy of gs-9901 monotherapy in adults with fl, mzl, cll, or sll.


Eligibility criteria:
inclusion criteria: * diagnosis of fl, mzl, sll, or cll (meeting international workshop on cll \[iwcll\] criteria, 2008) as documented by medical records and with histology based on criteria established by the world health organization * fl grades 1, 2, or 3a * sll with absolute lymphocyte count of \< 5 x 10\^9/l at initial diagnosis * mzl (splenic, nodal, or extra-nodal) * prior treatment for fl or cll/sll with ≥ 1 prior chemotherapy-based or immunotherapy-based regimen with no approved therapies available * presence of radiographically measurable lymphadenopathy or extra nodal lymphoid malignancy * all acute toxic effects of any prior antitumor therapy resolved to grade ≤1 before the start of study therapy (with the exception of alopecia \[grade 1 or 2 permitted\], or bone marrow parameters \[any of grade 1, 2, or 3 permitted) * eastern cooperative oncology group (ecog) ≤ 2 * able to provide written informed consent exclusion criteria: * history of lymphoid malignancy other than fl, mzl, sll, or cll * history of myelodysplastic syndrome * history of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for ≥ 1 year prior to start of study therapy, or any other cancer that has been in complete remission for ≥ 5 years * evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study therapy * ongoing drug-induced pneumonitis * ongoing inflammatory bowel disease * history of prior allogeneic bone marrow progenitor cell or solid organ transplantation * history of prior therapy with any inhibitor of serine/threonine kinase (akt), bruton tyrosine kinase (btk), janus kinase (jak), mammalian target of rapamycin (mtor), phosphatidylinositol 3-kinase (pi3k), or spleen tyrosine kinase (syk) * ongoing immunosuppressive therapy, including systemic corticosteroids for treatment of lymphoid malignancy

Keywords: chronic lymphocytic leukemia (cll) follicular lymphoma (fl) small lymphocytic lymphoma (sll) phosphatidylinositol 3 kinase (pi3k) marginal zone lymphoma (mzl)
extension study of long-term safety and efficacy of myozyme for a single patient with pompe disease who were previously enrolled in genzyme sponsored ert studies.

Conditions: Pompe Disease Late-Onset; Glycogen Storage Disease Type II GSD II

Summary: this extension study was to monitor the long-term safety and efficacy of rhgaa treatment in a single patient with infantile-onset pompe disease who were previously treated with rhgaa in a genzyme study.


Eligibility criteria:
inclusion criteria: * provide written informed consent prior to participating in any study related procedures; * currently enrolled in protocol aglu01402 * have the ability to comply with the clinical protocol, which required extensive clinical evaluations for an extended period of time. exclusion criteria: * was pregnant or unwilling to use approved birth control during the course of the study; * had experienced any unmanageable aes under protocol aglu01402 (as determined and agreed upon by the principal investigator and sponsor) due to rhgaa that would preclude continuing ert; * was participating in any other investigational study.