Kornimate/medical-research-clean huggingface dataset:
intratumoral cancer chemotherapy through a flexible bronchoscope as an adjunct to brachytherapy

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this study is being conducted in order to determine if intratumoral chemotherapy will be helpful in the palliation of endobronchial tumors when used in conjunction with endobronchial brachytherapy.

injections of cisplatin are given in conjunction with the brachytherapy procedure. if the direct intratumoral injections result in a decrease in the endobronchial obstructed airways and if the therapy is well tolerated, there will be immediate clinical benefit to this minimally invasive method, the most obvious being an improved quality of life. approximately 2 mg cisplatin per cubic centimeter of tumor are injected into each tumor through a flexible bronchoscope. a total of four to six injections are administered one week apart. response to therapy is assessed based on improvement in intraluminal obstruction by tumor, as assessed by endobronchial observation.

Eligibility criteria:
inclusion criteria: * patients with inoperable lung carcinoma and/or recurrent disease. * patients with symptomatic obstruction. * occlusion or partial occlusion of bronchi. * disease verified via bronchoscopy. * patients with a least one endobronchial tumor, measuring at least 0.5 cm. * patients between ages of 20 and 80 years. * documented informed consent must be obtained. exclusion criteria: * patients without diagnosis confirmed by bronchoscopy. * patients with endobronchial tumors measuring less than 0.5 cm. * patients younger than 20 or older than 80 years. * patients who do not sign informed consent form.

Keywords: lung chemotherapy cisplatin intratumoral bronchoscope brachytherapy
concentrations of raltegravir in the semen of hiv-infected men

Conditions: HIV

Summary: the objective of this study is to determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of hiv during the dose interval. the secondary objective is to determine the extend of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval, to determine the area under the concentration time curve of raltegravir in semen, and to determine the variability in the penetration of raltegravir into the seminal compartment over the dosing period.

the patient population will consist of 12 male hiv-positive patients who have been receiving stable antiretroviral therapy that includes raltegravir for a minimum of three months. patients will be enrolled from one clinic in downtown toronto and a hospital affiliated hiv specialty clinic in ottawa, ontario. eligible patients will have evidence of full virologic suppression (hiv viral load \< 50 copies/ml) at least one month prior to enrollment in the study. no changes will be made to the patients antiretroviral therapy during the course of the study.

Eligibility criteria:
inclusion criteria: * hiv infected male * 18 years old or older * on raltegravir twice daily as part of their antiretroviral regimen for at least 3 months prior to screening * viral load \< 50 copies/ml at least one month prior to enrolling * able to read, understand and sign a written informed consent prior to initiation of the study * medically stable at the time of the study, with no evidence of acute illness exclusion criteria: * having difficulty adhering to current antiretroviral therapy * patient is expected to have difficulties adhering with study protocol * patients with malignancy, or acute renal or liver disease * patient with active aids-defining illness * patient with any medical, psychiatric or other circumstance that may impede the provision of informed consent * patient with any of the following abnormalities at the time of screening: * hemoglobin \< 85 g/l * absolute neutrophil count \< 1000 cells/ul * platelet count \< 50,000 cells/ microleter (ul) * aspartate aminotransferase (ast), alanine transaminase (alt) or total bilirubin \> 3 times the upper limit of normal * serum creatinine \> 1.5 times upper limit of normal * patient receiving concomitant therapy with rifampin or st. john's wort
an observational study of treatment, outcomes, and prognosis in patients with follicular non-hodgkin's lymphoma

Conditions: Lymphoma, Non Hodgkin

Summary: this is a prospective, observational, longitudinal, multicenter study of patients with newly diagnosed follicular non hodgkin's lymphoma (nhl) designed to delineate differences in clinical outcome by comparing the effectiveness and safety of common treatment regimens.


Eligibility criteria:
inclusion criteria: * signed informed consent form (unless the institutional review board \[irb\] has granted a waiver of consent) * signed authorization for the use and disclosure of health information document * age ≥18 years * histologic documentation of follicular nhl, according to revised european-american lymphoma (real) classification system, as assessed by the local pathologist and treating physician * initial diagnosis of follicular b-cell nhl within 6 months prior to enrollment * availability of cancer-specific historical data points in the patient's medical records exclusion criteria: * other indolent or histologic nhl subtypes * diagnosis of lymphoma \> 6 months prior to enrollment

Keywords: follicular non-hodgkin's lymphoma
quetiapine augmentation of pe therapy for the treatment of co-occurring ptsd and mild traumatic brain injury

Conditions: Post Traumatic Stress Disorder

Summary: a pilot study to evaluate feasibility for a full-scale merit application. specifically, for veterans considering prolonged exposure (pe) therapy, following the model established by foa et al, we need to establish safety, and feasibility of quetiapine compared to treatment as usual (tau) which employs multiple medications commonly used for ptsd in the va system.


Eligibility criteria:
inclusion criteria: 1. all treatment seeking adult (≥ 18 years) 2. veterans with mtbi who meet ptsd diagnosis and have a caps-5 score of 25 or greater. diagnosis will be determined using the provisional ptsd diagnosis convention recommended by the national center of ptsd which requires at least moderate ratings (2 or more) on at least 1 b item (items #1-5), 1 c item (items #6-7), 2 d items (#8-14), and 2 e items (items #15-20) of the clinician administered ptsd scale for dsm-5 (caps-5). exclusion criteria: (1) pregnant or lactating women and those of child-bearing potential not using a reliable method of contraception; (2) individuals meeting dsm-5 criteria for schizophrenia, schizoaffective disorder, or neurocognitive disorder; (3) individuals currently taking any typical or atypical antipsychotic medication or individuals using daily benzodiazepines including nonbenzodiazepine z-drugs for sleep as they have effects similar to benzodiazepines for sleep. (note: benzodiazepine use is contraindicated as they may impair learning required for progress with pe) (4) individuals with known intolerance to quetiapine or a history of clinically unstable heart, lung, liver, renal or endocrinological condition, diabetes mellitus, and/or seizure disorder. (5) individuals with substance use disorder severe enough to require medical detoxification. (6) individuals who report suicidal or homicidal ideations in the past month severe enough to warrant inpatient admission. (7) individuals with current or known history of cardiac arrhythmia or qtc interval ≥ 450 milliseconds. (note) patients requiring other anti-arousal medication for general medical conditions such as antihypertensive medications, beta blockers etc., for hypertension, anti-thyroid medications for hyperthyroidism, and/or anti-epileptic medications, divalproex, levetiracetam, or carbamazepine for seizure disorder may be included if stable for at least 1 month before the screening visit.
rwanda vaginal microbiota restoration study

Conditions: Bacterial Vaginosis

Summary: a pilot randomized controlled clinical trial of intermittent use of two different vaginal lactobacilli-containing probiotics, and oral metronidazole, to prevent bacterial vaginosis recurrence.

this is a pilot study to prepare for larger clinical trials. sixty-eight hiv-negative, non-pregnant, sexually active women aged 18-45 with bacterial vaginosis (bv, by modified amsel criteria and/or nugent score) and/or trichomonas vaginalis (tv, on wet mount or by culture) will be treated using oral metronidazole for 7 days. after successful treatment, and when they are free of vaginal candidiasis, other curable sexually transmitted infections (stis) and urinary tract infection (uti)), they will be randomised to 4 different vaginal microbiome (vmb) maintenance interventions (17 per group) within 3 days of completing oral metronidazole treatment: 1) behavioral 'vaginal practices cessation and safer sex' counselling only (control); 2) behavioral counselling plus 500mg metronidazole pills twice per week for two months; 3) behavioral counselling plus ecologic femi vaginal capsule, once per day for 5 days immediately after oral metronidazole treatment followed by thrice weekly, for two months; 4) group 4: behavioral counselling plus gynophilus vaginal tablet, once every 4 days for two months. vaginal probiotic use may be ceased temporarily during menstruation. participants will be asked to adhere to the interventions for 2 months, and vmb assessments will take place before (screening and enrolment visits), during (day 7, month 1 and month 2 visits), and after the interventions (month 6 visit).

Eligibility criteria:
inclusion criteria: * sexually active, defined as having had sex at least twice in the two weeks prior to screening * at high risk of hiv/stis/bv, defined as having had more than one sexual partner in the last 12 months or having been treated for an sti and/or bv in the last 12 months * successfully treated for bv (modified amsel criteria) or tv (wet mount), and free of stis, symptomatic vaginal candidiasis and uti at enrollment * currently in good physical and mental health as judged by a study physician * willing and able to adhere to study procedures and provide written informed consent. exclusion criteria: * pregnant * hiv positive * clinician-observed genital ulcers, condylomata, or other genital abnormalities at screening or enrollment * underwent a gynaecological surgery/invasive procedure in the 3 months prior to screening * history of significant urogenital prolapse, undiagnosed vaginal bleeding, urine or faecal incontinence, or blood clotting disorders * allergic to metronidazole or any other components of the study drugs * not willing to stop use of other oral or vaginal probiotics from the screening visit until the end of study participation * participating in another health intervention study * for any other reason potentially interfering with participant safety or protocol adherence as judged by the principal investigator
impact of a physical activity intervention with motivational support from peers for prostate cancer patients

Conditions: Prostate Cancer

Summary: despite the recognized benefits of physical activity in tertiary prevention, 60-70% of prostate cancer patients are insufficiently active. yet 150 minutes of brisk walking per week (new who recommendations) is associated with a 29% reduction in cancer mortality and a 57% reduction in recurrence. increasing patients' adherence to regular physical activity appears to be a new challenge for personalized cancer care. personalized physical activity programmes (1) at home, (2) supported by health professionals, or (3) by peers have shown the effectiveness of regular physical activity. however, these interventions last less than 6 months and do not allow for long-term sustainability of physical activity. this study proposes to combine 3 interventions, which aim to initiate and maintain regular physical activity in prostate cancer patients: * 1-the realization of a personalized and realistic physical activity project via physical activity support devices (sport health centers) * 2-coaching by a peer (a patient with the same disease who has reached the who recommendations for physical activity), who will provide motivational follow-up * 3-support by health professionals (attending physician) through the prescription of physical activity. the feasibility of acti-pair program has been demonstrated, the investigators now wish to evaluate it effectiveness.


Eligibility criteria:
inclusion criteria: patients: * age ≥ 18 years * diagnosed with prostate cancer for at least 1 year * pa practice \< 150 minutes per week (considered inactive according to who) * affiliated or entitled to a social security scheme * having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study exclusion criteria: for patients: * undergoing treatment (except hormone therapy) * significant comorbidities contraindicating the practice of physical activity: associated cardiac pathologies, respiratory pathologies, disabling joint pathologies * deprived of liberty or under guardianship

Keywords: physical activity prostate cancer interventional research
clinical study with the selexys pc and the rm pressfit vitamys cup

Conditions: Hip Joint; Arthritis, Degenerative

Summary: this is a randomized controlled trial with the selexys pc cup and rm pressfit vitamys cup in combination with the optimys short stem. wear rate and migration is assessed with roentgen stereophotogrammetric analysis (rsa) measurements.


Eligibility criteria:
inclusion criteria: * patients with symptomatic arthritis who are candidates for a primary total hip arthroplasty with an uncemented femoral stem as determined jointly by the surgeon and the patient. * patients suitable for an uncemented acetabular component in combination with a 36mm femoral head (selexys pc cup: 52mm, 54mm or 56mm; rm pressfit vitamys: 52mm, 54mm or 56mm) * patients between the ages of 50 and 75 inclusive * patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up exclusion criteria: * patients that require an acetabular cup size which cannot be used in combination with a 36mm femoral head * patients that offer no guarantee for regular follow-up controls * patients that have a revision surgery * patients that have a fracture of the femoral neck or a bone tumour in the area of the femur or pelvis * patients that had a previous osteotomy of the femur or pelvis * pregnant women or those seeking to become pregnant * patients with a history of active infection

Keywords: total hip replacement roentgen stereophotogrammetric analysis
can you reduce diabetes symptomatology by becoming your 'best possible self': the role of stress and resilience

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to examine how the 'best possible self' (bps) intervention influences diabetes symptomatology over a four week period by assessing stress and resilience as mediatory effects. half of the participants will receive the bps straight away while the other half will be put on a waiting list and will act as the control group.

the bps is a "positive" psychology intervention; i.e. it facilitates positive emotion in order to achieve psychological, behavioural, and even physiological changes. the present team's previous research has demonstrated that the bps is effective at reducing certain diabetes symptoms, though the exact mechanisms by which it does so are unclear. according to the stress buffering model of physical activity, psychological stress is the catalyst that triggers behavioural and physiological responses critical to health while positive emotions can improve health by helping people to cope. the broaden and build theory of positive emotions, meanwhile, suggests that this is because positive emotions allow people to build resilience. in this study, the aim is to examine whether stress and resilience in particular mediate the relationship between intervention and diabetes symptoms. research around stress and resilience has shown these factors to be important not only in the physical health of people with diabetes but for also decreasing illness symptomatology in non-clinical samples more generally.

Eligibility criteria:
inclusion criteria: * non-clinical sample * 18+ * access to the internet exclusion criteria: * severe mental illness (such as schizophrenia or bipolar depression)

Keywords: prevention psychology self-management
ketogenic diet and diabetes demonstration project

Conditions: Type 2 Diabetes; PreDiabetes; Obesity; Ketogenic Dieting

Summary: kddp is a prospective, 12-month pilot study comparing the effects of a novel lifestyle program, the ketogenic diet and diabetes demonstration project (kddp) to those of the national diabetes prevention program (nddp). kddp is modeled to mimic the delivery platform of ndpp with the exception that participants in kddp will be placed on a medically-supervised ketogenic diet, and participants in ndpp will be placed on a low fat diet. the purpose of this study is to compare the metabolic effects of the kddp and the ndpp on glycemic control, lipid parameters, blood pressure, heart rate, weight, and coronary artery calcium scores in individuals with either type 2 diabetes or prediabetes.

kddp is a prospective, 12-month pilot study comparing the effects of the kddp vs. cdc ndpp in patients with obesity and dysglycemia. kddp is the ketogenic diet and diabetes demonstration project arm. individuals enrolled in the kddp arm will attend a mandatory weight management class through the center for diabetes and nutrition education, and they will participate in a standard comprehensive lifestyle intervention program that is identical to that of the ndpp with the exception of dietary recommendations. individuals in the kddp arm will be educated on and follow a ketogenic diet (\<20g carbohydrates/day). they will receive guidance on tracking carbohydrate intake daily, and home point-of-care ketone breath testing will be performed at regular intervals to ensure that ketosis is being achieved and maintained. they will attend weekly educational sessions facilitated by trained dieticians. individuals enrolled in the cdc ndpp arm will adhere to a low fat diet and receive identical follow up with the dieticians relative to those enrolled in the kddp arm. individuals in both arms will be matched for age, sex, weight, and a1c. baseline measures at study entry will include weight, height, systolic and diastolic blood pressure, heart rate, hemoglobin a1c, fasting plasma glucose, total cholesterol, triglycerides, hdl cholesterol, and ldl cholesterol. these parameters will be measured every 3 months throughout the study and at study completion. additionally, participants in both groups will be consented to undergo cac scanning at baseline and at 12 months to assess for any differences in dietary interventions on cac scores.

Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years old * bmi ≥27 kg/m2 * hemoglobin a1c ≥ 5.7% and/or fasting plasma glucose of 100-125 mg/dl exclusion criteria: * known clinical cardiovascular disease (i.e. prior stroke, myocardial infarction, peripheral artery disease) * ldl cholesterol ≥ 190 mg/dl * triglycerides ≥ 500 mg/dl * history of type 1 diabetes * history of diabetic ketoacidosis * individuals requiring insulin * advanced renal disease * advanced liver disease * terminal cancer * pregnancy
dapagliflozin and pulmonary artery hemodynamics in heart failure with reduced ejection fraction patients with cardiomems®

Conditions: Heart Failure, Systolic

Summary: the focus of this study is to investigate the use of dapagliflozin in hfref (nyha ii-iv) patients with or without diabetes who have cardiomems® implanted to assess the impact on pulmonary artery pressure measurements after 12 weeks of therapy.

prior studies have demonstrated an association between the use of sodium-glucose cotransporter 2 (sglt-2) inhibitors for diabetic patients and reductions in composite primary outcomes of cardiovascular mortality, nonfatal myocardial infarction, or nonfatal stroke, as well as reductions in heart failure among patients with diabetes. the 2019 dapa-hf trial studied whether the addition of the sclt-2 inhibitor dapagliglozin could benefit patients with heart failure with reduced ejection fraction (hfref), either with or without diabetes. results indicated that that sglt-2 inhibitors resulted in 4.9% absolute reduction in the cardiovascular death or worsening heart failure and a 2.3% absolute reduction in all-cause mortality in patients with and without diabetes. dapagliflozin is fda approved to reduce the risk of cardiovascular death or hospitalization in patients with hfref with or without type 2 diabtes. the mechanisms of cardiovascular benefit remain unclear, however it is likely to be driven by a reduction in heart failure death given that rates of myocardial infarction were similar between treatment arms. the cardiomems® system is an implantable device that can measure pulmonary artery systolic, diastolic and mean pressure on a daily basis. it has been shown convincingly that monitoring the mems device results in reduced pulmonary pressures and in turn a reduction in heart failure hospitalizations. the focus of this study is to investigate the use of dapagliflozin in hfref (nyha ii-iv) patients with or without diabetes who have cardiomems® implanted to assess the impact on pulmonary artery pressure measurements after 12 weeks of therapy.

Eligibility criteria:
inclusion criteria 1. diagnosis of hfref and existing cardiomems in place 2. patients who have historically been compliant with cardiomems followup 3. ejection fraction \< or = to 40% 4. new york heart association (nyha) class ii-iv heart failure 5. able to read and write in english exclusion criteria 1. creatinine clearance less than or equal to 45 2. history of renal transplant 3. systolic blood pressure less than 85 on time of initiation of drug 4. intolerance/allergy to farxiga 5. pregnant patients or those who are planning to become pregnant during the study period 6. unable to read and write in english 7. acutely hospitalized patients or those who were hospitalized in the past 30 days 8. history of noncompliance with cardiomems followup 9. history of frequent mycotic urinary tract infections 10. history of organ transplantation
effect of antioxidant cocktail in beta-thalassemia/hb e patients

Conditions: Thalassemia

Summary: the purpose of this study is to determine the efficacy of antioxidant cocktails on the alleviation of oxidative stress and iron overload in beta-thalassemia/hb e patients.

60 cases of beta-thalassemia/hb e patients. all patients will be diagnosed with hemoglobin typing of beta-thalassemia/hb e disease and not receive blood transfusion or any treatment at least 3 months prior study. the study will be randomized controlled trial that designed before and after treatment with antioxidant cocktail. the antioxidant cocktail consists of vitamin e 400 iu/day, curcuminoids 500 mg/day, n-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day. all patients will receive antioxidant cocktail daily for 12 months. the patients will be regularly followed up and analyzed biochemical parameters every two months during treatment and after withdrawal for 3 months.

Eligibility criteria:
inclusion criteria: 1. age between 18-50 years 2. hemoglobin level between 6-9 g/dl during screen visit 3. who performance status grade 0-2 4. signed in informed consents prior to the study entry. exclusion criteria: 1. receiving iron chelator and blood transfusion. 2. pregnancy or breastfeeding 3. receiving other drugs except folic acid at least 30 days before study.

Keywords: thalassemia oxidative stress antioxidant cocktail