Kornimate/medical-research-clean huggingface dataset:
topotecan in treating patients with recurrent brain tumors

Conditions: Brain and Central Nervous System Tumors

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 topotecan in treating patients with recurrent brain tumor.

objectives: i. determine the efficacy of topotecan in patients with recurrent anaplastic oligodendroglioma or anaplastic mixed oligoastrocytoma. ii. determine the qualitative and quantitative toxicity of topotecan in this patient population on this schedule. outline: this is a multicenter study. patients receive intravenous topotecan over 30 minutes daily for 5 days every 3 weeks. treatment continues in the absence of disease progression or unacceptable toxicity. patients will be followed every 3 months until death. projected accrual: up to 30 evaluable patients will be accrued within 2-3 years.

Eligibility criteria:
disease characteristics: histologically proven recurrent anaplastic oligodendroglioma or anaplastic mixed oligoastrocytoma following primary surgery and radiation therapy tumors for anaplastic mixed oligoastrocytoma must contain at least 25% oligodendroglial elements tumors must be clinically aggressive for patients with only 1 anaplastic feature prior low grade oligodendrogliomas or oligoastrocytomas undergoing repeat biopsy following clinical or radiological progression are eligible bidimensionally measurable and progressive lesions by ct or mri patient characteristics: age: 18 and over performance status: ecog 0-3 life expectancy: not specified hematopoietic: absolute granulocyte count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: not specified renal: creatinine normal other: not pregnant or nursing fertile patients must use effective contraception no prior malignancies except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer no other serious illness or medical condition no active uncontrolled infection no history of neurologic or psychiatric disorder prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 6 weeks since chemotherapy no more than 1 prior chemotherapy regimen no prior camptothecin derivatives endocrine therapy: at least 2 weeks on stable steroid therapy, if necessary radiotherapy: at least 2 months since prior radiotherapy no prior radiation therapy for recurrent disease surgery: at least 6 weeks since prior surgery (except biopsy only) prior surgery for recurrent disease allowed (including stereotactic biopsy or partial resection) other: no concurrent experimental drugs or anticancer therapy

Keywords: recurrent adult brain tumor adult anaplastic oligodendroglioma adult mixed glioma
anti-il5 and other biotherapies in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: our project is to describe retrospectively and prospectively cf patients treated with biotherapy in french cf centers. main objective: to describe the clinical and paraclinical course of cf patients before and after treatment with anti-il5 and other biotherapies since 2019. secondary objective: to describe adverse events potentially related to the biotherapies.

•background: abpa and asthma associated with cystic fibrosis impact the cf course with a more rapid decline in lung function. corticosteroid therapy can be harmful and must be avoid in cf to prevent diabetes, osteoporomalacia or mycobacterium infections. monoclonal antibodies have the marketing authorization for severe uncontrolled asthma and, up to now, some cf patients with abpa or severe asthma and high plasma ige levels benefit from omalizumab. anti-il5 agents are available since february 2019 and have demonstrated their efficacy in severe and hypereosinophilic asthma control (plasma eos.\>300mmol/l). some patients with cf who have severe asthma or abpa are still poorly controlled despite omalizumab with other treatments (steroids and/or azoles). some of them have persistent hypereosinophilia suggesting a possibility to treat with antiil5 antibodies. about 5% of patients have biotherapy treatment criteria, some have already received it, others are elective to such treatment and will receive in the future. methods: our project is to describe retrospectively and prospectively the clinical history of cf patients eligible for biotherapy in french cf centers. main objective: to describe the clinical and paraclinical course of cf patients before and after treatment with anti-il5 and other biotherapies since 2019. secondary objective: to describe any adverse events potentially related to the biotherapies.

Eligibility criteria:
inclusion criteria: * cystic fibrosis (2 known variants) * age ≥ 6 years * plasma hypereosinophilia ≥ 300/µl * uncontrolled abpa or uncontrolled asthma, or failure of other biotherapy (intolerance, ineffectiveness) exclusion criteria - refusal to participate in this research

Keywords: cystic fibrosis biotherapy anti-il5 benralizumab apba severe asthma
malmö treatment referral and intervention study

Conditions: Heroin Addiction; Substance Use Disorders

Summary: this study aims to study and implement active referral of heroin users from a syringe exchange programme to evidence-based treatment for heroin addiction. patients are randomized to either a strength-based case management intervention or a control group, while both groups receive referral to medical investigation for inclusion in substitution treatment for heroin addiction. the hypothesis is that syringe exchange can be used for referral to effective treatment, and that a strength-based intervention can increase the number of patients who are successfully referred and enter treatment.

patients attending the syringe exchange programme of malmö, sweden, and who are using heroin as their primary drug of abuse and who live in the catchment area of malmö addiction centre, will be addressed, and patients willing to participate will undergo a baseline interview and will be referred to medical examination for decision to start substitution treatment to treat heroin dependence. half of patients will be randomized to a strength-based case management intervention, hypothesized to facilitate treatment entry, and half of patients will be randomized to a control condition involving only referral. the study will measure the number of patients who successfully accept referral and initiate substitution treatment for heroin dependence, comparing patients in intervention arm to patients in the control condition (rct design). also, as a secondary outcome measure, retention and treatment outcome (substance use and clinical characteristics) will be compared between the two groups. in addition, this study will enable a number of sub-analyses aiming to increase knowledge about heroin addicts' detailed substance use pattern and clinical characteristics. patients will be followed with respect to retention, substance use and clinical picture for three years.

Eligibility criteria:
inclusion criteria: * registered at syringe exchange programme of malmö * primary drug heroin * heroin dependence * living in catchment area for substitution treatment of addiction centre malmö exclusion criteria: * inability to understand consent and information * unstable psychiatric condition making treatment regulations impossible * pregnancy

Keywords: heroin addiction substance use disorders substitution treatment syringe exchange
circulating mrgd in pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: the aim of the study is to observe the change of the circulating mrgd level in patients with pulmonary hypertension compared with subjects without pulmonary hypertension.


Eligibility criteria:
inclusion criteria for patients with pulmonary hypertension： 1. male or female aged ≥18 years 2. right heart catheterisation to check the mean pulmonary artery pressure (mpap) ≥25mmhg 3. the patient is willing and able to provide written informed consent. exclusion criteria for patients with pulmonary hypertension： 1. age less than 18 years old 2. mean pulmonary artery pressure (mpap) \<25mmhg 3. unable to provide informed written consent for participation in the study 4. renal insufficiency 5. liver insufficiency 6. malignant tumor 7. active infection 8. pregnancy inclusion criteria for control subjects： 1. male or female aged ≥18 years 2. no evidence of pulmonary hypertension on echocardiography or mean pulmonary artery pressure (mpap) \< 25 mmhg on right heart catheterization, and no evidence of clinically relevant heart disease 3. no evidence of clinically relevant pulmonary disease exclusion criteria for control subjects： 1. age less than 18 years old 2. mean pulmonary artery pressure (mpap) ≥25mmhg 3. unable to provide informed written consent for participation in the study 4. symptoms of heart failure or clinically relevant lung disease 5. renal insufficiency 6. liver insufficiency 7. malignant tumor 8. active infection 9. pregnancy
n-acetylcysteine in bulimia nervosa

Conditions: NAC

Summary: this study tests nac in the treatment of bulimia nervosa.


Eligibility criteria:
inclusion criteria: * bulimia nervosa * 18-65 years of age
study of simtuzumab in hiv and/or hepatitis c- infected adults with liver fibrosis

Conditions: Liver Fibrosis; Hepatitis C; HIV; HIV/HCV Co-infection

Summary: the primary objective of this study is to assess the safety and tolerability of simtuzumab (formerly gs-6624) in hiv and/or hepatitis c virus (hcv)-infected adults with evidence of liver fibrosis.


Eligibility criteria:
key inclusion criteria: * hiv-infected individuals must have positive serologies with viral load suppressed below 400 copies/ml * hcv-infected individuals must have: * chronic hcv infection with hcv rna ≥ 2000 iu/ml and at least 1 of the following: * been null responder to previous pegylated interferon and ribavirin therapy or * failed to achieve sustained virologic response (svr) on a regimen containing a direct-acting antiviral (daa) in addition to pegylated interferon and ribavirin or * are unwilling to receive or have contraindications to interferon therapy for hcv * hiv/hcv co-infected individuals must have: * positive hiv serologies with viral load suppressed below 400 copies/ml * chronic hcv infection with hcv rna ≥ 2000 iu/ml and at least 1 of the following: * been null responder to previous pegylated interferon and ribavirin therapy or * failed to achieve svr on a regimen containing a direct-acting antiviral (daa) in addition to pegylated interferon and ribavirin or * are unwilling to receive or have contraindications to interferon therapy for hcv * willing to allow blood and tissue samples to be stored for future use to study hiv infection, immune function, liver disease and additional mechanisms involved in liver fibrosis among patients with hiv and/or hcv, which may not be related directly to the specific objectives of this study protocol * have a primary care physician key exclusion criteria: * cause of liver fibrosis other than hcv or long-term antiretroviral therapy (art) treatment for hiv * currently being treated for hcv * evidence of active hepatitis a, b or d infections * history or evidence of hepatocellular carcinoma * unwillingness to undergo a liver biopsy pre-treatment and post-treatment, or to undergo all other protocol required tests/procedures or return to the site for required visits * presence of contraindications to magnetic resonance imaging (e.g., presence of any metal in the body, cardiac or neural pacemaker, aneurysm clip, cochlear implant, claustrophobia)

Keywords: liver fibrosis fibrosis hiv hcv gs-6624 hepatitis hepatitis c
fabian prospective assessment of volume guarantee (fabian pavog)

Conditions: Respiratory Insufficiency in Children

Summary: this study is planned as a part of the post market clinical follow-up (pmcf) on a ce marked product and will provide performance data on the volume guarantee function of the fabian ventilator in daily clinical routine.

pavog study is a prospective, multicenter, single-cohort post market observational study. the study procedures will be conducted according to standard of care of each participating hospital and the instructions for use of the study device. to allow data collection, an informed consent form will be obtained from each study participant/ legally authorized representative, if required by the local ethical committee. ventilator data will be recorded in the hospital's data capture system or on a study laptop provided by the sponsor. each patient will be clinically evaluated according to hospital standard of care. if inclusion and exclusion criteria are met, and the investigative team is available the patient will be enrolled. study duration for an individual patient will differ, depending on the time spent on fabian ventilator with volume guarantee mode on. it is anticipated that for most will be between 2-4 days.

Eligibility criteria:
inclusion criteria: * patient ventilated with fabian ventilator (conventional or hfov) with vg mode active. * the anticipated use of vg mode is at least 12 hours * informed consent given by parents or guardians according to the process approved by the local research ethical committee exclusion criteria: * patients with severe airflow obstruction and intracranial hypertension * decision documented to give palliative neonatal care. * the clinical care team does not agree with inclusion of the infant to the study
a multiple dose study to determine safety, tolerability, and pharmacokinetics of pf-04634817 in healthy adult subjects

Conditions: Healthy

Summary: the goals of this study are to evaluate the safety and tolerability of multiple ascending doses of pf-04634817 administered orally to healthy adult subjects. in additional, the plasma and urinary pharmacokinetics of multiple ascending doses of pf-04634817 administered orally to healthy adult subjects will be evaluated. finally, the effect of multiple doses of pf-04634817 on circulating monocytes will be explored.


Eligibility criteria:
inclusion criteria: * healthy male and female (of non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease; * treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication; * use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day; * nursing females; * females of childbearing potential.

Keywords: healthy volunteers pharmacokinetics safety tolerability multiple dosing diabetic nephropathies
food reinforcement, weight status, and energy density

Conditions: Reinforcing Value of Food

Summary: the investigators previous studies have shown that obese and non-obese individuals respond differently to daily intake of snack food. the purpose of this study was to determine whether these differences are specific to high energy density snack foods. the investigators hypothesized that obese individuals would show an increase in motivation to obtain high energy density snack foods after two weeks of daily consumption, but that non-obese women and obese women consuming low energy density foods would have reduced motivation to consume snack foods after two weeks of daily consumption.


Eligibility criteria:
inclusion criteria: * 18 - 50 years old, female, like study foods. exclusion criteria: * current smoker, currently on a diet, medical conditions or medication affecting appetite (ex. methylphenidate).

Keywords: food reinforcement food liking motivation dopamine obesity energy density snacks
in the mirror: functional appreciated bodies (im fab)

Conditions: Eating Disorder Symptom; Body Image Disturbance

Summary: the current project aims to examine the concept of promoting attention toward body functionality and gratitude using a weekly functionality-based mirror exposure and body functionality gratitude "journaling" text prompts three days a week for three weeks to examine whether this helps foster positive body image and decrease eating disorder symptoms in a sample of undergraduate females, a population at particularly high risk of body image dissatisfaction and consequent eating disorder development.

specific aim 1. first, the project aims to test a gratitude-based body functionality primary prevention program, in the mirror: functional appreciated bodies (im fab), that incorporates mirror exposure with a greater intervention "dose" than that piloted by brooks and walker. the increased dose should allow for greater ability for participants to consolidate exposure-based learning. specifically, more time instructed to appreciate the body's functionality allows for more occasions to redirect critical appearance-oriented cognitions to appreciative, function-based cognitions. specific aim 2. second, the project aims to pilot test a relatively minimalistic intervention that would be easily translated to app-based delivery format, to help overcome the most-cited barriers to prevention program participation noted by undergraduate students in universal prevention research. specifically, undergraduate participants who were assigned to a prevention program but did not enroll questioned a need for counseling/therapy, reported preferring to deal with issues on their own, and cited a lack of time as reasons they did not enroll. specific aim 3. third, the project aims to test this specific functionality mirror exposure approach largely on its own, rather than as part of a multicomponent treatment program, so that its unique contribution in preventing body image dissatisfaction, and ultimately eating disorders, can be assessed. a main goal in prevention and treatment development remains to continuously test components of body-image interventions separately for efficacy.

Eligibility criteria:
inclusion criteria: * undergraduate female aged 18-23 years. exclusion criteria: * self-definition as having an active eating disorder * participation in the body project
mental health and medication adherence among msm in south africa

Conditions: HIV

Summary: the goal of this behavioral study is to improve psychological well-being and optimization of hiv prevention and care outcomes for men who have sex with men (msm) in south africa.

men who have sex with men (msm) are at an increased risk of hiv infection and transmission, and msm with depression or anxiety may have adherence to medication challenges. development of an integrated mental health and adherence support intervention for msm can be an effective strategy to improve both psychological outcomes and care continuum outcomes including adherence to pre-exposure prophylaxis (prep) and anti retroviral therapy (art). the team proposes developing an intervention approach that responds to the unique social contexts of south african msm living with or at risk for hiv, and that addresses the relationship between mental health and adherence to hiv prevention medication (daily prep) and art. this intervention approach, wecare, will adapt an evidence-based program entitled friendship bench (i.e., fb) - an empirically supported mental health program using problem-solving therapy (developed/validated in southern africa) - to incorporate mental health and medication adherence concerns for msm.

Eligibility criteria:
inclusion criteria: * cis-gender male * reside in the johannesburg metropolitan area with no plans to relocate during the next 6 months * current prescription for any art regimen (hiv-positive participants) or daily oral prep (hiv-negative participants) at the pop inn clinic * self-reported challenges adhering to daily art (hiv-positive participants) or prep (hiv-negative participants) * interested in participating in a group discussion to discuss common mental health problems and medication adherence challenges * ability to understand and provide informed consent. exclusion criteria: * presently engaged in mental health therapy. * participated as an intervention participant in a pilot mental health study (aur6-8-403) * refuses audio recording of the focus group discussion * those who score over 20 on the phq-9 (i.e., indicating severe depression)

Keywords: msm prep art
using vegetable and berry products can improve skin conditions

Conditions: Skin Condition

Summary: hypothesis: vegetable and berry products for 8 weeks can improve skin condition

hypothesis: using vegetable and berry products for 8 weeks can improve skin condition

Eligibility criteria:
inclusion criteria: 1. dry skin 2. rough skin 3. large pores 4. dark yellow complexion 5. sagging skin exclusion criteria: 1. skin disorders 2. liver diseases 3. kidney diseases 4. allergy to cosmetics, drugs, or foods 5. pregnant and lactating women 6. people who had any cosmetic procedures before 4 weeks of the study 7. area of facial spot over 3 cm2 8. vegan 9. people who took collagen supplements in the past 3 months.
value antiproteinuric effects from vitamin d derivatives in patient with chronic kidney illness and the lack of vitamin d

Conditions: Kidney Failure, Chronic; Disorder of Vitamin D

Summary: the purpose of this study is to determine the value the additional antiproteinuric effects of vitamin d derivatives treatment, in patients with chronic kidney illness phase ii-iv, with lack of vitamin d and residual proteinuria higher 0,5 grams/day.


Eligibility criteria:
inclusion criteria: * male/female patients older 18 years old * patients have signed written informed consent * chronic kidney illness phase ii-iv plus residual proteinuria \>0,5 grams/day (two or more consecutive occasions) and plus beta blockers treatment from aars during al least 3 months. * serum levels of calcifediol in the lack of level (15-30 ng/ml). exclusion criteria: * bad control of high blood pressure (higher or same 180/110 mmhg) * bad control of diabetes (hba1c higher 9,5 in the last three months period) * hypercalcemia (\ 5,5 mg/dl), caxpo4\>50, hypercalciuria (urin ca/cr quotient \> 0,15) * vitamin d treatment or any analogous * hepatic failure ( ast o alt \> 3 times higher than normal limit) * medical history of poor nutrient intestinal absorptions or chronic diarrhea * active nephrolithiasis * treatment with medication wich can change vitamin d metabolism (phenobarbital, phenytoin, rifampicin) * participation in other clinic trial in 3 last months * active alcoholism * neoplasia precedent (except cutaneous no melanoma) * pregnant women or while breastfeeding * vitamin d hypersensitivity or any its excipient hypersensitivity * any other condition from research
a study of cellcept (mycophenolate mofetil) in kidney transplant patients switched from ec-mps.

Conditions: Kidney Transplantation

Summary: this study will assess the safety, efficacy and effect on quality of life of switching kidney transplant patients from reduced dose ec-mps treatment due to gastrointestinal problems to a higher than the equimolar dose of cellcept. patients will be switched, initially, from ec-mps (\<1440g/day) to an equimolar dose of cellcept, and at the next visit (day 10 +/- 5) the cellcept dose will be increased by 250mg/day, and the daily dose will be split into 3-4 doses. the anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * first or second kidney transplant; * ec-mps therapy for \>=6 months, with a stable dose for \>=2 months; * lower than recommended dose of ec-mps (\<1440g/day) due to gastrointestinal complaints. exclusion criteria: * patients who have participated in this study before; * patients currently participating in another clinical trial, or who participated in one during the last 30 days.