Kornimate/medical-research-clean huggingface dataset:
ph ii study of wkly topotecan + bevacizumab in plat. resistant/recurrent gyn cancers

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Summary: the purpose of this study is to evaluate the clinical safety and toxicity of intravenous bevacizumab (days 1 and 15 of a 28 day cycle) in combination with weekly topotecan (days 1, 8, 15 of a 28 day cycle) in patients with platinum resistant recurrent ovarian, fallopian tube and primary peritoneal cancer.

this study is designed as a phase 2 study. there are no published data on the toxicity of the combination of bevacizumab and topotecan therapy. based on data combining bevacizumab with other chemotherapy agents in non-gynecologic solid tumors, it is not likely that the toxicity of the combination of the two drugs will be greater than the individual toxicities of each drug. the toxicities of each of these agents is quite different. specifically the toxicity of this combination will be studied using the dose of bevacizumab used in previous phase ii studies of ovarian cancer, e.g. an equivalent of 5 mg/kg weekly with treatments given at least every 3 weeks. in our study, since topotecan will be given weeks 1,2 and 3 of an every 4 week cycle, it is convenient to give bevacizumab 10 mg/kg iv every other week.

Eligibility criteria:
inclusion criteria: * must have received primary taxane and platinum-based chemotherapy and no more than 1 other chemotherapy regimen * must have platinum resistant disease(defined as recurrence within 6 months of receiving platinum based chemotherapy, first or second line) * must have measurable disease (greater than 20mm by conventional techniques or 10mm by spiral ct) or elevated ca-125 (\> 100 on two occasions at least one week apart * performance status greater than or equal to 70% exclusion criteria: * prior treatment with anti-angiogenesis agent * treatment with \> 2 cytotoxic regimens (including primary platinum and taxane chemotherapy) * evidence of other malignancy within 3 years of study enrollment * history of abdominal fistula, grade 4 bowel obstruction or gastrointestinal perforation * history of intra-abdominal abscess with 6 months prior to day 0 * pregnant or lactating patients

Keywords: platinum resistant ovarian cancer recurrent ovarian cancer platinum resistant cancer
evolution of the heart function when monitoring immunotherapies anti-cancerous inhibiting pd-1

Conditions: Melanoma; Non-small Cell; Lung Cancer

Summary: prospective, monocentric clinical study. patients selected for nivolumab therapy in ap-hm for melanoma and non-small cell lung cancer will be eligible. do not include patients with conditions that do not allow mri, prior cardiovascular disease with lvef\<50%, cardiomyopathy, history of cardiac arrhythmia, history of cardiovascular toxicity under anticancer therapy, coronary artery disease or stroke less than 3 months therapeutic management will not be modified and treatment will be administrated as usual. cardiovascular follow up will be identical to that recommended and realized in current care in the cardio-oncology unit of ap-hm. it will include clinical, biological (bnp and troponin) and trans-thoracic echocardiography (tte) at baseline and then at 1, 3 and 6 months. auto-antibodies against troponin i assay will be performed to avoid false negatives of normal blood level of troponin i at baseline and then at 6 months. cardiac mri will be performed as well at baseline and at the end of the study (6 months). mri is the gold standard for ventricular function evaluation. primary endpoint will be left ventricular function evolution evaluated by global longitudinal strain (gls, 2d speckles tracking) in tte. secondary endpoints will be left and right ventricular function parameters: levf by tte and mri, left ventricular indexed volumes by tte and mri, right ejection ventricular function and indexed volumes by tte and mri, systolic pulmonary arterial pressure by tte, serum troponin i and bnp, arrhythmias and conduction disorders on the electrocardiogram (ecg). number of required subjects: gls is recommended for following up left ventricular function under anticancer treatments. based on the hypothesis of a significant gls decrease (15%) in 20% of cases with alpha risk of 0.05 and accuracy of 0.12 which means expected confidence interval of 0.08-0.32, then the number of required subjects is 50 patients. the inclusion period will be 18 months with a follow up if 6 months, ie a total duration of the study of 24 months.


Eligibility criteria:
inclusion criteria: patients treated with nivolumab exclusion criteria: * age \<18 years * preliminary cardiac disease with fevg \<50% * cardiomyopathy dilated, hypertrophic or restrictive * history of cardiac arrhythmia * history of cardiac toxicity under another anti-cancer treatment * known coronary disease * history of stroke less than 3 months old * patient not wishing to participate in the study * vulnerable persons (pregnant women, adults under guardianship or guardianship, persons deprived of their liberty)
optimal heparin dosing regimens for cardiopulmonary bypass

Conditions: Postoperative Hemorrhage

Summary: study has been completed and is in the data analysis and manuscript writing phase of the project.


Eligibility criteria:
inclusion criteria: * adult male and non-pregnant female patients scheduled for elective cardiac surgery requiring cpb will be eligible for enrollment. exclusion criteria: * age less than 18 or greater than 90 years; emergency surgery * circulatory arrest * combined non-cardiac procedures such as carotid endarterectomy * congenital heart repair * off-cpb coronary artery bypass grafting (cabg) * clotting disorder * fibrinolytic agents (e.g. streptokinase), severe hepatic disease * aprotinin use * cooling \< 28 degrees c during cpb * dialysis dependent renal failure; and * platelet receptor gp3a/2b antagonists medication received within 48 hours of surgery. patients that are not receiving tranexamic acid (ta) intraoperatively will be excluded.

Keywords: heparin management
low dose tomosynthesis compared to traditional tomosynthesis

Conditions: Breast Neoplasms

Summary: this study aims to evaluate image quality of a low-dose tomosynthesis system versus a comparator. subjects will undergo a four-view tomosynthesis examination with the comparator and with the study device, and images will be assessed by several radiologists by comparing details in the images from the two systems.

tomosynthesis is a relatively new technology to acquire mammographic images where images are acquired over several projection angles, giving 3d information that can help radiologists assess images. the aim of the study is to see whether a new low-dose tomosynthesis system has comparable image quality at a lower x-ray radiation dose to a comparator.

Eligibility criteria:
inclusion criteria: * woman over 40 years of age * has a tomosynthesis examination with comparator * has a mammographic finding exclusion criteria: * pregnant, breastfeeding or believes she may be pregnant * unable or unwilling to give informed consent
hyperthermia and the amelioration of autism symptoms

Conditions: Autism Spectrum Disorder

Summary: the febrile hypothesis of autism spectrum disorder (asd) stems from the observation that clinical symptoms improve during fever. this fever induced amelioration of symptoms could be due to one of three possible causes, (1) the direct effect of temperature; (2) a resulting change in the immune inflammatory system function associated with the infection or fever; and/or (3) and increase in the functionality of a previously dysfunctional locus coeruleus-noradrenerigic (lc-na) system. little has been done to explore the potential direct effect an increased body temperature may have on autism symptomology. parental reports have demonstrated that during febrile episodes children with asd have improved social cognition and language skills, and decreased disruptive behaviors. in order to further explore the direct temperature effect, further investigation is needed, which the investigators propose below. the investigators propose to complete a one year double blind crossover study with 15 children with asd between the ages of 5 and 17 years old. five children with asd will complete a control protocol prior to beginning the full protocol with 10 additional asd children. this will allow for any needed amendment of protocol parameters prior to completion of the full protocol.


Eligibility criteria:
asd controls inclusion criteria * aged 5 to 17 * meets asd criteria on the dsm-iv tr that is supported by the ados or the adi-r asd control exclusion criteria * children who are currently ill will not begin treatment until they are well. * females who are pregnant. * children who have abnormally high blood pressure prior to starting study treatment. * children with a bmi greater than 30.0 or below 18.5 * children with history of seizures or cardiovascular problems asd case inclusion criteria * meets asd criteria on the dsm-iv tr that is supported by the ados or the adi-r * aged 5 to 17 * have a past history of improvement during febrile episodes asd case exclusion criteria * children who are currently ill will not begin treatment until they are well. * females who are pregnant. * children who have abnormally high blood pressure prior to starting study treatment. * children with a bmi greater than 30.0 or below 18.5 * children with history of seizures or cardiovascular problems

Keywords: autism asd aspergers autism spectrum disorder
inpatient closed-loop glucose control

Conditions: Diabetes Mellitus; Hyperglycemia

Summary: the purpose of this study is to test an experimental medical device designed to automatically control blood sugar. this device was designed for use by patients with diabetes while they are in the hospital, and others who may develop high blood sugar as a result of their medical problems.

the goal of this first-in-man trial is to test the safety and efficacy of the automated, closed-loop control system in insulin sensitive subjects with type 1 diabetes, insulin sensitive subjects with type 2 diabetes (ttd \> 1u/kg/day), and subjects with type 2 diabetes and substantial insulin resistance (\<2 u/kg/day). the results of this study will help to design future studies, exploring the use of the closed-loop system for bg control in hospitalized patients, including those with diabetes or hyperglycemia of critical illness.

Eligibility criteria:
inclusion criteria subjects with type 1 diabetes * age 21 to 75 with clinical type 1 diabetes for at least one year * diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins * total daily dose (tdd) of insulin that is \< 1 u/kg subjects with type 2 diabetes * age 21 to 75 with clinical type 2 diabetes for at least one year * diabetes managed using nph as the basal insulin, which may be supplemented with regular or rapid-acting insulin * total daily dose (tdd) of insulin that is \> 1 u/kg/day but \ 2 u/kg/day exclusion criteria: * pregnancy * renal insufficiency * cancer * abnormal ekg suggestive of coronary artery disease or increased risk of malignant arrhythmia * acute illness or exacerbation of chronic illness at the time of the study procedure * use of non-insulin, injectable anti-diabetic medications or oral anti-diabetic medications other than metformin * history of allergy or adverse reaction to aspirin, peptic ulcers or bleeding disorders * known history of coronary artery disease, tia or stroke * history of seizures * transaminitis * stage 2 hypertension at the time of screening

Keywords: closed-loop blood glucose control continuous glucose monitoring bionic pancreas artificial pancreas
a non-interventional study to assess the influence of automated optical coherence tomography image enrichment with segmentation information on disease activity assessment in patients treated with licensed anti- vegf injections

Conditions: Neovascular Age-Related Macular Degeneration

Summary: razorbill was an observational, multicenter, multinational, open-label, study designed primarily to investigate the influence of automated oct image enrichment with segmentation information on disease activity assessment in namd patients treated with licensed anti-vegfs

the main goal of this study was to assess to what degree disease activity assessment is influenced and supported by the enrichment of oct images with segmentation information (i.e. by identification, highlighting and quantification of pathological fluid compartments associated with neovascular activity). the study comprised a prospective data collection phase and a retrospective analysis of oct images phase. the prospective observation period per patient was up to 12 months. the study included patients (naïve patients and patients who had been pre-treated with licensed anti-vegfs not more than 3 years) being treated for namd with brolucizumab, ranibizumab, or aflibercept according to the respective drug label.

Eligibility criteria:
inclusion criteria: * diagnosis of namd * male and female patients with ≥18 years of age at index * receipt of at least one injection of brolucizumab, ranibizumab or aflibercept during the recruitment period * signed written informed consent * patients for whom a therapy with brolucizumab, ranibizumab or aflibercept is medically indicated according to the respective label * intraretinal and/or subretinal fluid affecting the central subfield of the study eye at screening exclusion criteria: * patients treated for any other retinal disease than namd within 6 months prior to the index date (e.g. patients treated for retinal vein occlusion, diabetic macular oedema, myopic cnv, and have diagnoses of diabetes-related macular degeneration) * central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis \>50% of the total lesion in the study eye at screening * any active intraocular or periocular infection or active intraocular inflammation in either eye at index date * patients who have been on anti-vegf treatment for longer than 3 years (before index date) * patients who have any contraindication and are not eligible for treatment with the chosen anti-vegf treatment as according to the respective label. * any medical or psychological condition, in the treating physician's opinion, which may hinder the patient from participating in this study for the expected 12 months * patients participating, in parallel, in an interventional clinical trial * patients participating, in parallel, in any other novartis sponsored nis generating primary data for an anti-vegf drug

Keywords: namd neovascular age-related macular degeneration anti-vegf razorbill optical coherence tomography oct artificial intelligence machine learning automatic oct segmentation
purification of testis-stimulating factor in precocious puberty

Conditions: Precocious Puberty

Summary: objectives: purify and characterize a testis-stimulating factor in the blood of adult volunteers who had precocious puberty as boys.

protocol outline: subjects are treated for 2 months with depot injections of leuprolide acetate every 4 weeks and testosterone replacement every 2 weeks. hormone levels are tested every other week. if luteinizing hormone and follicular-stimulating hormone levels are at or below detection on day 56, blood is drawn for a testis-stimulating factor bioassay and subsequent factor purification and characterization. volunteers are asked to repeat this 2-month procedure no more than 2 times every 12 months.

Eligibility criteria:
protocol entry criteria: adult men diagnosed with precocious puberty (familial testotoxicosis) as boys

Keywords: endocrine disorders precocious puberty rare disease
microbiological and microscopic evaluation of atraumatic restorative treatment in adult dentition

Conditions: Dentin Caries; Infection

Summary: atraumatic restorative treatment (art) was proposed as a new and effective method in the 1990s to provide conservative dental treatment to the people living in economically underdeveloped countries, due to lack of dental treatment facilities. in the technique, after the carious dentin is removed by excavation with hand instruments, the powder-liquid system conventional glass ionomer cement (gic) which does not require special devices for mixing and hardening is used as a filling material. because of these advantages of the treatment, the usage fields of art have been expanded considering that it can be applied in the cases that working with rotary instruments is difficult or even impossible. but only a few research has been conducted on art in adults and it must be investigated in terms of the clinical safety of art by the studies focused on the counts and activities of the microorganisms in carious dentin left on the cavity floor. the purpose of this study is to investigate the reliability of art in adult individuals related to the marginal adaptation of the restorations and the microbiological changes in the left carious dentin using in vitro and in vivo methods. in the in vivo part of the study, occlusal dentin carious of 25 participants at high risk of caries were removed with hand instruments and microorganisms of the last removed carious dentin were evaluated quantitatively concerning the bacterias playing a major role in caries lesions. the restorations of the teeth were carried out using art technique with a gic which has been proven its effectiveness in preventing the caries progression and recurrent caries in the practice of dentistry for many years. after six months, the microbiological assessment was repeated such as baseline. marginal adaptation and the presence of the gaps in the art restorations on the replicas created with the impression materials at the baseline and sixth month were investigated under scanning electron microscope. at the end of the study, the teeth were restored by the conventional methods and using composite material.


Eligibility criteria:
inclusion criteria: patients: * 19-35 years of age; * good general health; * high risk of caries; * no evident signs of occlusal parafunctions. tooth: * molar tooth; * 3-4 mm depth occlusal dentin caries; * vital; * in occlusion; * proper tooth axes. exclusion criteria: patient: * using regular medication; * pregnancy or lactation; * received radiotherapy or chemotherapy; * tooth clenching, bruxism. tooth: * spontaneous pain; * radiographic alterations in the periapical region; * presence of tooth mobility; * previously restored; * broken and/ or cracked.

Keywords: atraumatic restorative treatment glass ionomer cement marginal adaptation
family preparation study for withdrawal of mechanical ventilation from their family member

Conditions: Mechanical Ventilation; Critically Ill

Summary: using the self-regulation theory, an intervention to prepare families for that experience was developed. this study will assess the impact of the intervention on a family's evaluation of their preparation and their short-term coping. the site used for this study will be the trauma and life support center (tlc), university of wisconsin (uw) hospital. after a decision has been made to withdraw life support, a member of the tlc staff will approach the next of kin of the patient to inform him/her about the study and inquire about his/her interest to participate. using an experimental design, 10 family members will be assigned to the control group and 10 to the intervention group. upon agreement, a research nurse will use a "coin toss method" for group assignment of the subjects until there are ten in each group. experimental group subjects will receive the intervention after the family meeting. demographics of the next of kin will be collected at this time. patient information such as demographics, diagnosis, and time of withdrawal and death will be collected too. two to four weeks after death, a telephone interview will be conducted with the next of kin using the "evaluation of the experience of withdrawal" questionnaire and the profile of mood state - shortened version. potential benefits are that the families will be prepared for the experience of the dying patient, which will help them cope better during withdrawal and after their loss. there are no major risks to the subjects but there might be an increase in psychological distress.


Eligibility criteria:
inclusion criteria: * next of kin of a patient who will have withdrawal of life support * participant must be 18 years of age or older and read, write, and speak english exclusion criteria: * family is unusually highly emotional * patient will be a living donor * patient is conscious

Keywords: dying
addressing hypertension care in africa

Conditions: Hypertension; Diabetes; Telemedicine

Summary: a pilot cluster randomized control trial to test the feasibility of a multilevel, nurse-led, mobile health enhanced intervention in patients with uncontrolled hypertension in ghana

this is a two-arm pilot cluster randomized controlled trial (rct) involving 240 participants with uncontrolled hypertension (htn) with the healthcare setting as the unit of randomization and patients as the unit of analysis. each of the four healthcare settings will be recruited and randomly assigned to the multilevel intervention or control group. a statistician will generate the randomization using a computer-generated random sequence program with an allocation ratio of 1:1 and a block size of 6 (to assure equal numbers in each arm). after having met study criteria for enrollment, 60 eligible patients for each setting will be assigned to either control or intervention arm according to the patients' healthcare setting's intervention assignment by the study coordinator. a cluster rct has been chosen to avoid potential treatment contamination in which physicians within healthcare settings might unintentionally provide patients with different degrees of attention or blending of treatment protocols. the intervention will be administered for six months following which it will be withdrawn, and patients will be followed for six more months to assess outcomes. the investigators will use quota sampling to over sample socioeconomically deprived persons to ensure that socioeconomically deprived persons comprise 50% of the sample. poverty will be defined by (1) household income, based on ghana minimum monthly wage of 210 ghana cedis (equivalent of $55). after screening eligible participants, the investigators will assign four clusters of 60 patients to the intervention or control arms. the investigators will require 30 patients in each cluster to be male and 30 to be female since in the investigators' previous work, men have been underrepresented potentially due to gender-differences in healthcare seeking behaviors. men have also had inferior treatment and control rates in previous studies.

Eligibility criteria:
inclusion criteria: * patients will be included if they are 18-70 years old; * male or female * uncontrolled hypertension (sbp ≥140 mm hg) based upon last outpatient encounter within the previous three months * patients with previous strokes, coronary artery disease, up to stage three kidney disease and diabetes mellitus meeting bp cut-off criteria will be eligible for enrollment. exclusion criteria: * patients will be excluded if they fail to meet any of the above inclusion criteria * severe cognitive impairment/dementia (modified mini-mental state examination (mmse) score ≤24) * severe global disability (modified rankin scale (mrs) score ≥3) * not able to independently follow blood pressure measurement protocol or use of smartphone for study protocol or without a care-giver to assist with bp monitoring at home * patients with estimated glomerular filtration rate (egfr) \<30ml/min