Kornimate/medical-research-clean huggingface dataset:
registry to measure the impact of adding genomic testing

Conditions: Prostate Cancer

Summary: this is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer. physicians will complete a series of questionnaires. biopsy tissue will be tested using the prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician and the patient.

this is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer . physicians, using standard clinical-pathological parameters (psa, gleason score, clinical stage and percent positive cores), will complete a questionnaire that will record their recommendation for first-line therapy from among various treatment options. a sample of the biopsy tissue will then be tested using the prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician. after reviewing and considering the results of the genomic testing but prior to the patient consult, the physician will then complete a second treatment decision questionnaire and vas again. the physician will then discuss the recommended treatment plan with the patient and record the agreed treatment plan on a third questionnaire. after the initial treatment has been initiated, the physician or research staff will record the actual treatment administered in the fourth questionnaire (preferably recorded within 3 months of the patient consultation).

Eligibility criteria:
inclusion criteria: * newly diagnosed (\< or equal to 12 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics: * psa less than or equal to 10 ng/dl and * gleason's 7 (4+3 or 3+4) or gleason's 6 and * age greater than 55 years old and * clinical stage t1 or t2 * clinically localized (no evidence on clinical or imaging studies of advanced disease). * no hormonal therapy including luteinizing hormone-releasing hormone (lhrh) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable. exclusion criteria: - known history of hypogonadism
chemotherapy clage-ven sequential with reduced intensity conditioning for refractory acute myelodi leukemia

Conditions: Refractory Leukemia

Summary: the investigators developed a protocol combining chemotherapy of cladribine, cytarabine and etoposide (clage) as debulking treatment sequential with reduced intensity conditioning regimen flu-bu to treat patients with refractory acute myeloid leukemia (aml). in this study, the aim is to further evaluate the efficacy and feasibility of the protocol with modifications: 1) reduced dose of clage; 2) reduced intensity conditioning (ric) regimen as fludarabine, busulfan and melphalan (mbf) or total marrow irradiation (tmi); 3) venetoclax was added to the chemotherapy and conditioning regimen.

refractory aml is associated with poor prognosis. allogeneic stem cell transplantation is considered as the only curative therapy. unfortunately, conventional transplantation protocol usually has high relapse rate and high nor-relapse mortality. in previous studies, the investigators established a protocol using intensive chemotherapy (cladribine, cytarabine and etoposide) to reduced the leukemia burden followed by reduced intensity conditioning regimen of flu-bu3 with 7 day interval. all patients received maintenance therapy. the 1-year relapse rate was less than 20% but toxicity such as lethal infection was documented in sizable part of patients. in this study, the aim is to further evaluate the efficacy and feasibility of the protocol with following modifications: 1) dose of cytarabine and etoposide are reduced to 1g/m2 and 100mg/m2 daily; 2) conditioning regimen is based on flu-bu2 combined with addition of melphalan (100mg/m2) or total marrow irradiation (tmi) in case of contra-indication for busulfan or melphalan; 3) venetoclax is added to the chemotherapy and conditioning regimen. the modifications intend to reduce both the toxicities and relapse, which may turn into a benefit of disease-free survival (dfs). this is designed as a phase ii multi-center prospective study to evaluate the feasibility and efficacy of the protocol.

Eligibility criteria:
inclusion criteria: * patients with refractory aml: no remission after 2 induction therapy, relapsed aml within 6 months of 1st cr, relapse aml fail to having cr after reinduction therapy, multiple relapse and refractory relapse aml * patients with \>5% bone marrow blast by morphology or by laip flowcytometry at enrollment * patients with hla-matched sibling donor, 9-10/10 matched unrelated donor or haplo-identical family donor * patients without active infection * informed consent provided exclusion criteria: * patients with abnormal liver function (enzyme \>2n or bilirubin \>2n) * patients with abnormal renal function (scr \>1.5n) * patients with poor cardiac function （ef\<45%）

Keywords: refractory aml, allogeneic stem cell transplantation
a safety study of combination treatment with avonex and placebo-controlled dosing of topamax in relapsing-remitting multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this is a clinical trial in relapsing-remitting multiple sclerosis to determine if topamax added to avonex has a neuroprotective effect as measured by the brain parenchymal fraction ( a measure of brain shrinkage) and by clinical assessment scores to evaluate disease progression.

the protocol requires all participants to be treated with avonex and in addition patients will be blindly assigned to either a group who receive topamax or a placebo control. repeated neurological and clinical examinations are performed with laboratory tests to determine any possible adverse drug effects. the scaled neurologic examinations (edss and msfc) and brain mri's are done at regular intervals to evaluate possible treatment effects.

Eligibility criteria:
inclusion criteria: relapsing-remitting multiple sclerosis - exclusion criteria: secondary progressive multiple sclerosis contraindication to mri systemic disease pregnancy -

Keywords: relapsing-remitting multiple sclerosis brain atrophy disease progression
a phase 1/2 study of ramucirumab plus nivolumab in participants with gastric or gej cancer

Conditions: Gastric Cancer; Gastroesophageal Junction Region (GEJ) Cancer

Summary: the main purpose of this study is to evaluate the safety and efficacy of the combination therapy of ramucirumab and nivolumab in participants with advanced or recurrent unresectable gastric or gej cancer.


Eligibility criteria:
inclusion criteria: * advanced or recurrent unresectable gastric or gej cancer * histologically confirmed adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma or poorly differentiated adenocarcinoma), signet-ring cell carcinoma, mucinous adenocarcinoma or hepatoid adnocarcinoma * patients with normal oral intake * eastern cooperative oncology group (ecog) performance status 0 or 1 * patients who have measurable target lesion * patients has a refractory or intolerant pretreatment by pyrimidine fluoride anticancer agent and platinum-based anticancer agent * patients with adequate organ function * patients with no pretreatment history including ramucirumab, nivolumab or other therapies targeting control of t cells * patients with written informed consent exclusion criteria: * patients have double cancer * patients have infection required systemic therapy * known central vervous system (cns) metastasis * patients with history of pneumonitis or pulmonary fibrosis * patients with history of serious anaphylaxis induced by antibody preparation * patients who have known active autoimmune disease or history of chronic recurrent autoimmune disease * female who is pregnant, lactating or suspected pregnancy * patients with psychosis or dementia to interfere to obtain informed consent appropriately
prospective national survey of the palliative situation among inmates in french prisons

Conditions: Critical Illness; Terminal Illness

Summary: parme study had 3 objectives: * to identify the specific number of incarcerated individuals with terminal illness in need of palliative care. * to describe the health and penal situation of these prisoners. * to analyse the situation of these ill prisoners especially in the context of suspended sentence for medical ground in order to answer these questions, the investigators used a mixed method research.

first, in order to establish a baseline, the investigators contacted the medical units in all french prisons, which means 178 care units and 8 secures inpatient care units. the investigators census every patient with terminal illness, which was defined in this study as an evolutive pathology with a life prognosis less than a year. a questionnaire was completed by these physicians for every situation. the census was conducted for three months across france. for the qualitative study, the investigators selected 14 specific situations chosen into these which had been identified by the physicians. the investigators wanted to get 3 types of patients : 1. patient who had obtained a compassionate release 2. patient whose demand has been refused 3. patient who did not demand any release. the four interviews (patients, physisians, judges, probation workers) for each situation has explained the global situation. each interviewee spoke about the situation with his/her perspective and sense that they attributed to the actions of others. this research analyzes the particularity of each of these end of life situations in prison.

Eligibility criteria:
inclusion criteria: * prisonners * serious and evolving pathology * vital prognosis less than a year exclusion criteria: * less than 18 year * person under tutelage * patient who refuse to participate

Keywords: palliative care vulnerable population qualitative research
anti10a levels in women treated with lmwh in the postpartum period

Conditions: Venous Thromboembolism

Summary: the aim of this study is to compare between anti-10a levels in postpartum women receiving different prophylactic doses of lmwh: one group with lmwh doses adjusted by the women's weight and the second group receiving 1mg/kg to a maximum dose of 120 mg

pregnancy and postpartum period are associated with increased risk of thromboembolism. this risk is further increased in women with thrombophilia. this risk is higher in the postpartum period compared with pregnancy period, especially the risk for pulmonary embolism (pe). the american college of obstetrics and gynecologists, the american college of chest physicians and the royal college of obstetricians and gynecologists recommend using low molecular weight heparin during the postpartum period in women with thrombophilia and women with risk factor for developing thromboembolism. there is no specific guidelines regarding the best protocol based on the level of anti-10 a. this study will compare between two protocols based on anti-10a levels.

Eligibility criteria:
inclusion criteria: * postpartum women supposed to receive lmwh according to obstetric indications exclusion criteria: * known allergy to clexane * active bleeding postpartum * thrombocytopenia \< 75000 * recent cerebrovascular accident / transient ischemic attack (\<4 weeks) * glomerular filtration rate) \< 30 ml/min) * active liver disease * malignant hypertension (systolic \> 200 mmhg, diastolic\> 120 mmhg)

Keywords: postpartum venous thromboembolism prophylactic dose of low molecular weight heparin anti 10a
bronchial thermoplasty in severe asthma with frequent exacerbations

Conditions: Asthma

Summary: the purpose of this study is to demonstrate the effectiveness of bronchial thermoplasty in a severe asthmatic population with frequent exacerbations. this will be a single center randomized and controlled study. thirty subjects with severe asthma (gina 4 and 5) with frequent severe exacerbations (four or more bursts of systemic corticosteroids \>3 days each in the previous year) will be randomized 1:1 to either the thermoplasty group (bronchial thermoplasty and medical management) or control group (medical management only).


Eligibility criteria:
inclusion criteria: * age 18-65 years * asthma which requires treatment with guidelines suggested medications for gina steps 4-5 * four or more bursts of systemic corticosteroids \>3 days each in the previous year * willingness and ability to give written informed consent exclusion criteria: * current smoker and former smoker \> 10 pack years total smoking history * participation in another clinical trial within the prior 4 months * omalizumab therapy within the prior 4 months * allergic bronchopulmonary aspergillosis * patient having had severe exacerbation of their asthma requiring high doses of oral corticosteroids (\> 60 mg equivalent prednisolone) more than one month in the previous year * post-bronchodilator fev1 of less than 30% * past diagnosis of copd and chronic respiratory insufficiency * known coagulopathy or platelet dysfunction * use of anticoagulants * use of an internal or external pacemaker or internal cardiac defibrillator * contraindication to perform bronchoscopy * contraindication to perform general anesthesia * significant cardiovascular disease * current or recent respiratory tract infection resolved less than 4 weeks * known cancer or cancer history less than 12 months * pregnancy and nursing mother

Keywords: asthma, asthma exacerbation bronchial thermoplasty
pharmacokinetics of caspofungin after one dose in patients with liver failure

Conditions: Bacterial Infections and Mycoses; Liver Disease

Summary: the objective of this study is to conduct a population pharmacokinetic analysis of caspofungin in a population of patients with moderate and severe acute alcoholic hepatitis or liver disease with child-pugh score b and c in order to better characterize pharmacokinetic parameters in case of moderate and severe liver dysfunction.

patients admitted for alcoholic hepatitis or decompensated cirrhosis and child-pugh score 7-9 and 10-15 will be included; all patients without invasive aspergillosis.

Eligibility criteria:
inclusion criteria: * liver failure child-pugh b and c exclusion criteria: * cachexia (bmi \< 15 kg/m²) * pregnancy * hiv * hepatitis c patients
habit-ile in infants and toddlers with cerebral palsy (baby habit-ile)

Conditions: Cerebral Palsy

Summary: using a randomized controlled trial design, the possible changes induced by the intensive treatment programme "hand-arm bimanual intensive therapy including lower extremities (habit-ile)" in functional, everyday life activities and neuroplastic assessment will be studied in infants and toddlers with cerebral palsy.

using a randomized controlled trial design, the possible changes in neuroimaging, motor function and everyday life activities of infants and toddlers at risk of or with a diagnosis of cerebral palsy after participating of the intensive treatment programme "hand-arm bimanual intensive therapy including lower extremities (habit-ile)" will be studied . changes, scored by parents in case of questionnaires and by experts in the case of tests, will be observed comparing infants/toddlers after their regular care and after receiving habit-ile. motor function and daily life activities will be correlated with neuroplastic changes. moreover, possible therapy onset outcomes differences will be observed.

Eligibility criteria:
inclusion criteria: * children with diagnosed unilateral cerebral palsy or at risk of developing unilateral cerebral palsy or with signs of unilateral cerebral palsy * age 8 to 18 months inclusive (corrected age if preterm birth) * ability to follow instructions and complete testing according to the age. exclusion criteria: * active seizure * programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 6 months after the intervention time. * severe visual impairments * severe cognitive impairments * contraindications to perform magnetic image resonance (mri) assessments (metal implants, etc.)
disease modification in toxaemia of pregnancy

Conditions: Pre-eclampsia

Summary: short description of the primary purpose of the protocol intended for the lay public. include brief statement of study hypothesis pre-eclampsia (toxemia of pregnancy) is the most cause of death among pregnant women in north america. it also causes many complications for fetuses (unborn children) and neonates (newborn children). pre-eclampsia is defined by high blood pressure (hypertension), the loss of protein into the urine (proteinuria), and disorders of many body systems, including the blood clotting (coagulation) and inflammation. what is needed is a compound that will safely prolong pregnancies, to give babies more time to grow inside their mothers, and will help the recovery in those mothers after delivery. we are going to investigate a compound (recombinant human activated protein c (rhapc)) that has the potential to modify disease activity in pre-eclampsia by reducing coagulation and inflammation disorders. rhapc is effective in patients suffering from septic shock. we will test rhapc in women who develop severe pre-eclampsia in two ways. first, in women with severe pre-eclampsia remote from term who are carrying small babies (intent: safely prolong their pregnancies). second, in women who have had severe pre-eclampsia before their baby delivered (including women in the first group), or whose disease develops/worsens after delivery (intent: switch off the disease so dangerous complications do not arise). this study is a preliminary one to look for possible risks and benefits for these women. only 40 women will be studied to provide initial evidence on which to base a larger international trial which is planned. we will study their pregnancy outcomes as well as markers of disease activity, to gain a better understanding of the mechanisms by which these women become unwell.


Eligibility criteria:
inclusion criteria: * scenario 1 is severe early-onset pre-eclampsia, where the fetal prognosis is dismal (\<50% chance of intact survival \[disease onset \<27+0 weeks gestation and/or estimated fetal weight \<600g\]. * scenario 2 is postpartum pre-eclampsia, where there is either severe antenatal disease, deteriorating postpartum disease, or de novo postpartum disease. exclusion criteria: -
the use of flecainide for treatment of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this prospective observational study will include patients with atrial fibrillation that has indication for treatement with flecainide. included patients are followed during a 12 month period. during the follow-up period they will have four clinical visits, during which clinical data, advanced echocardiographic data (strain and speckle tracking) and ecgs (glasgow criteria) will be collected. these data will be analysed in relation to outcome parameters as: maintaining a normal sinus rhythm (arrythmia free health status), number of af-free months, chances of successful electrical cardioversion, frequency of side effects, risk of pro-arrhythmias and mortality. the importance of these two analyses is to improve the use of flecainide. hence, today patients with low benefit compared to risk of adverse events are inappropriately treated with flecainide with the "trial and error" approach currently used. on the other hand flecainide is currently underutilized, and patients denied the treatment that could improve their quality of life, prognosis and reduce their risk of cardiovascular adverse events. by investigating novel and promising parameters there is the potential of a better prediction of initiating safe and accurate anti-arrhythmic therapy for patients with atrial fibrillation.

study synopsis for the tambocor prospective study inclusion: patients with atrial fibrillation that admitted to the ward for prior to start of flecainide initiation. ethics: informed concent prior to inclusion. follow up after baseline: 4 visits during 12 month. end points : side effects that lead to discontinuation of flecainide. persistent af that lead to discontinuation of flecainide. evaluated parameters: 12 lead ecg, echo: la, lv, hv strain , dynamic heart model: lv and rv. the follow up visits: baseline: normal echo after the first dose of flecainide, ecg and questionnaire 4 weeks: normal echo + protocol echo (la, lv, hv strain , dynamic heart model: lv and rv) and questionnaire. 6 month: normal echo + protocol echo (la, lv, hv strain , dynamic heart model: lv and rv) and questionnaire. 12 month: normal echo + protocol echo (la, lv, hv strain , dynamic heart model: lv and rv) and questionnaire.

Eligibility criteria:
inclusion criteria: * all patients with written informed consent who are eligible for flecainide treatment for atrial fibrillation. * the patients must be followed at the skånes hospitals northwest and skånes university hospitals. * age \>18 years exclusion criteria: * flecainide treatment with other indication than atrial fibrillation (including atrial flutter). * no secure date for treatment start. * age \<18 years
study of safety, blood levels, and brain receptor occupancy of gsk163090 using pet imaging in healthy males

Conditions: Healthy Subjects; Depressive Disorder and Anxiety Disorders

Summary: the purpose of this study is to look at how much of a new drug, gsk163090, binds to proteins in the brain and how much stays in the blood over a range of different doses. this study will use a medical imaging technique called positron emission tomography (pet) which uses an imaging agent called \[11c\]-way100635.


Eligibility criteria:
inclusion criteria: * healthy male subjects, aged 18-45 years body weight \> 50 kg * non-smoker * normal ecg, heart rate and blood pressure exclusion criteria: * history of any cardiac disease * history of regular alcohol consumption averaging \>14 drinks/week * current or recent gastrointestinal disease; history of psychiatric illness including any history of suicidal attempts * positive for hepatitis b and c, and hiv. * history of drug abuse. * exposure to research and/or medical protocol involving nuclear medicine, pet or radiological investigations with significant radiation burden * family history of cancer (one or more first-degree relative diagnosed before the age of 55). * suffers from claustrophobia * history or presence of neurological or psychiatric conditions * presence of a cardiac pacemaker or other implanted electronic device or metal implants

Keywords: pet scan healthy males
feasibility of targeted bronchial washing for molecular testing by next generation sequencing in early-stage lung cancer

Conditions: Lung Cancer

Summary: this is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with next generation sequencing.

this is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of genetic alterations using next generation sequencing in patients suspicious of early-stage lung cancer.

Eligibility criteria:
1. inclusion criteria: * age ≥ 20 years * obtained written informed consent * subjects suspected of having resectable lung cancer on computed tomography * subjects without contraindication to brochoscopy * subjects planning to undergo surgery for suspected lung cancer and opting for tissue or liquid biopsy for genetic alteration using next generation sequencing 2. exclusion criteria: * subjects who withdraw informed consent * subjects who are unable to undergo liquid biopsy (plasma) and tissue biopsy - for genetic alteration with next generation sequencing based on the investigator's judgement * subjects diagnosed with a cancer other than non-small cell lung cancer from the lung tissue lesion * subjects diagnosed with a benign lesion from the lung tissue lesion

Keywords: bronchoscopy liquid biopsy lung cancer next generation sequencing