Kornimate/medical-research-clean huggingface dataset:
individual phenotype analysis in patients with castration-resistant prostate cancer with cellsearch® and flow cytometry

Conditions: Prostate Cancer

Summary: the recent data suggest that cancer cells at the origin of prostate cancer metastases can be detected in an early stage. available techniques allow phenotypic analysis of cancer cells in circulating blood (cellsearch) or in marrow hematopoietic (flow cytometry). pilot study on 180 patients infected by prostate cancer at all stage of disease, show that c-met marker , integrin alpha 2 and 6 expressed in marrow and quantified by flow cytometry were predictor of metastatic progress. in this new study the investigators will analyze antibody panel by cellsearch and flow cytometry on marrow sample of castration-resistant prostate cancer patients.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma or prostate * ongoing effective androgen deprivation therapy (testosterone ≤ 50 ng/ml) * castration-resistant prostate cancer patient : defined as a minimum of 3 rising psa values assessed and/or radiological progress confirmed by recist and pcwg2 * patient who signed informed consent exclusion criteria: * severe disorders of coagulation * major skin lesion on iliac crests * allergies in local anesthetics * psychological instability or psychiatric histories * uncertain follow-up and distant residence * history of another invasive cancer and hematologic disease * patient deprived of their freedom by court or administrative order * revocation of consent
an observational study in patients with mild to moderate covid-19

Conditions: COVID-19

Summary: the purpose of this study was to observe real-world disease progression in mild-moderate covid-19 patients with at least one risk factor for serve covid-19 illness or death.

screening interested participants should sign the appropriate informed consent (icf) prior to completion any study procedures. the investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria. the following is the general sequence of events during the 28-day evaluation period: completion of baseline procedures participants were assessed for 28 days and completed all safety monitoring.

Eligibility criteria:
inclusion criteria: * participants who have a positive sars-cov-2 test result. * participants who have one or more mild or moderate covid-19 symptoms. * participants who have one or more of the following requirements: ≤7 days from the first positive test for sars-cov-2 virus infection to day 1; ≤5 days from the first onset of covid-19 symptoms to day 1. * participants who satisfy one or more than one of the following high risks for progression to severe covid-19, including death. * participants who understand and agree to comply with planned study procedures. * participants or legally authorized representatives can give written informed consent approved by the ethical review board governing the site. * capable of giving signed informed consent, including of compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. exclusion criteria: * participants who are judged by the investigator as likely to progress to severe/critical covid-19 prior to randomization. * participants who have spo2≤93% on room air at sea level or pao2/fio2≤ 300, or respiratory rate ≥30 per minute. * participants who require mechanical ventilation or anticipated impending need for mechanical ventilation. * participants who have received or plan to receive a sars-cov-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment). * participants who have received convalescent covid-19 plasma treatment.

Keywords: mild to moderate covid-19
neural changes associated with a mindfulness-based intervention for young adults with childhood maltreatment

Conditions: Depression; Anxiety; PTSD; Trauma, Psychological

Summary: childhood trauma is remarkably prevalent, and it has long lasting impact on mental health and neural development. this trial aims to see whether the 8-week mindfulness based intervention can reduce stress related psychological symptoms for young adults with childhood maltreatment, and whether it can promote neural plasticity.

this study recruits young adults with childhood adversity; enrolled subjects either receive an 8-week mindfulness based intervention, or wait for 8 weeks before receiving the intervention. mri and a battery of self report questionnaires will be administered before and after the intervention; subjects on the waiting list will undergo the same research procedures at the same time as subjects in the intervention group. primary hypotheses include improved hippocampal plasticity, increased mindfulness and reduced stress and related psychological symptoms.

Eligibility criteria:
inclusion criteria: * experience of childhood maltreatment * with current age between 19 to 35 years old * with current symptoms of depression or anxiety or ptsd or significant general stress. exclusion criteria: * history of psychiatric disorders with psychotic features * suicidal attempts during the past six months * neurological disorders * and common mri exclusion criteria * prior history with the mindfulness based stress reduction program or other systematic meditation programs.

Keywords: depression anxiety childhood trauma mindfulness
postoperative changes in head and neck cancer patients undergoing surgery

Conditions: Head and Neck Cancer

Summary: the aim of this study is to evaluate the postoperative changes after a major surgery in head and neck cancer patients. each participant will be evaluated three times: (1) one day before surgery; (2) one month postoperative and (3) three months postoperative. assessments included blood pressure, anthropometric measurements, physical measurements and questionnaires on quality of life, nutritional status and cancer symptoms.


Eligibility criteria:
inclusion criteria: * diagnosis of head and neck cancer patients planned for an elective major surgery * more than 18 years of age * able to read, write and understand french exclusion criteria: - neurological or orthopedic impairments not suitable for testing
cardiovascular risk in people older than 55 years and cognitive performance at 5 years

Conditions: Risk Factor, Cardiovascular; Cognitive Decline

Summary: this study assesses whether people's cardiovascular risk influences cognitive performance in later years. to do this, the cardiovascular risk and cognitive performance of each patient will be evaluated at the beginning of the study and 5 years later.


Eligibility criteria:
inclusion criteria: * population aged 55 to 74 years from nedices 2 study * to have signed informed consent * to have done the neuropsicological assessment exclusion criteria: * to have a dementia diagnosis at baseline.

Keywords: cardiovascular risk prediction models framingham risk function fresco risk function risk function cognitive aging prevention
study of first time immunotolerance induction in severe hemophilia a patients with inhibitor at high risk of failure: comparison with fviii concentrates with or without von willebrand factor - res.i.s.t. naive

Conditions: Severe Hemophilia A

Summary: this is a prospective, controlled, randomized, open label study, aimed at comparing fviii/vwf concentrates with fviii concentrates at 200 iu/kg daily in their ability to induce immune tolerance in haemophilia a patients with high responding inhibitors and poor prognosis for success.

the presence of factor viii (fviii) inhibitor prevents fviii infusions from working properly and makes treatment of bleeding episodes very difficult. having an inhibitor is a serious and life-threatening complication in patients with hemophilia. the usual treatment of patients with fviii inhibitors involves "immune tolerance induction" (iti). immune tolerance means that the body can accept infused fviii and that fviii is again effective in controlling bleeds. iti involves giving high doses of fviii regularly until the inhibitor disappears. this treatment is not always effective. the inhibitor persists in about 1 in 5 patients who undergo iti. there are 2 types of fviii concentrates: fviii concentrates derived from human plasma, which contain the von willebrand factor, and concentrates of fviii without vwf (recombinant or plasma derived). both types of concentrates are commonly used to induce immune tolerance in patients with hemophilia a. retrospective studies in subjects with hemophilia and inhibitors at risk for failing iti, have indicated a higher rate of success if patients were treated with von willebrand containing factor viii concentrates. it is not known whether the addition of von willebrand factor offers an advantage to achieving immune tolerance.

Eligibility criteria:
inclusion criteria: 1. severe hemophilia a (fviii\<1%); 2. male, any age; 3. high responders (peak inhibitor levels \> 5 bu); 4. any inhibitor level at study enrolment; 5. ability and willingness to participate in the study; 6. at least one of the following risk factors for iti failure: * peak inhibitor titer \> 200 bu * titer at iti start \> 10 bu * age \> 7 years * time between inhibitor occurrence and iti \> 2 years 7. absence of high risk of cardiovascular, cerebrovascular or other thromboembolic events as deemed by the treating clinician. exclusion criteria: 1. concomitant systemic treatment with immunosuppressive drugs; 2. concomitant experimental treatment; 3. previous iti attempt; 4. previous history of myocardial infarction and/or cerebral stroke.

Keywords: iti haemophilia a inhibitors vwf/fviii concentrates
machine learning miscarriage management clinical decision support tool study

Conditions: Miscarriage in First Trimester

Summary: machine learning used to develop an algorithm to determine chance of success with expectant or medical management for an individual patient. taking into account the following objective measures: * demographics: maternal age, parity * history: previous cs, previous smm/mva, previous myomectomy * gestation by lmp * presenting symptoms: bleeding score, pain score * uss measurements: crl, gs, rpoc 3 dimensions, vascularity * discrepancy between gestation by crl and lmp audit to collate 1000 cases and identify features contributing to an algorithm that can predict outcome of miscarriage management for individualized case management.

* artificial intelligence discovery science: algorithm development based on a retrospective audit of approximately 1000 cases of miscarriage * to determine the reliability of the tool with test data sets * to increase the sensitivity and specificity of the decision aid by widening the data collection to multiple sites and testing the algorithm with prospective data the study will be conducted at queen charlotte's and chelsea hospital at imperial college healthcare nhs trusts (primary centre of the study). this is a multi-centre retrospective, cohort observational study. the study will be conducted over a minimum of three years to enable sufficient time to go through the retrospective data and collate test data sets. retrospective annonymised cases of missed miscarriage and incomplete miscarriage managed at imperial college healthcare nhs trust will be analyse: for each case the following clinical features will be collated and outcomes: * demographics: maternal age, parity * history: previous cs, previous smm/mva, previous myomectomy * gestation by lmp * presenting symptoms: bleeding score, pain score * uss measurements: crl, gs, rpoc 3 dimensions, vascularity * discrepancy between gestation by crl and lmp all data will be collected retrospectively and annonymised. following data collection, machine learning models and feature reduction methods will be applied to determine the best performing model to predict success or failure of expectant or medical management of miscarriage respectively. the next phase will include a prospective audit to collect data and test the predictive power of the mlm clinical decision support tool.

Eligibility criteria:
inclusion criteria: * missed miscarriage and incomplete miscarriage less than 14weeks gestation * follow-up recorded at 2 weeks exclusion criteria: - final outcome data unavailable
evaluation of the contribution of a dematerialized video-pedagogical support in the care pathway of lung cancer surgery patients

Conditions: Lung Cancer

Summary: uni-centric, randomized, open-label, prospective interventional-comparative study, with a control arm (patients receiving standard preoperative information) and an experimental arm (patients receiving standard preoperative information and having access to a dematerialized educational video support).


Eligibility criteria:
inclusion criteria: * patients aged 18 or over, * patients requiring surgical management: for therapeutic purposes (in the case of proven tumor histology) or for diagnostic and therapeutic purposes (in the absence of proven histology, but strong suspicion, after validation by rcp), - patients who have given their consent. exclusion criteria: * patients under guardianship * patients with a history of thoracic surgery * patients on long-term analgesic medication * patients who do not speak french * patients unable to read or write * patients with major visual impairment * patients with chronic anxiety or depression at the time of admission * patients under guardianship * pregnant or breast-feeding women

Keywords: lung cancer surgery anxiety video support
efficacy of buscopan® in comparison with 654-ii (anisodamine) in acute gastric or intestinal pain

Conditions: Intestinal Diseases

Summary: the aim of the study is to assess the efficacy of buscopan® (hyoscine butylbromide) in comparison to 654-ii (anisodamine)in acute gastric or intestinal spasm-like pain.


Eligibility criteria:
inclusion criteria: 1. patients must sign and date an informed consent consistent with international conference on harmonisation (ich)/good clinical practice (gcp) guidelines and local regulation prior to participation in the trial. 2. patients must agree to cooperate with all trial evaluations and perform all required tasks. 3. patients with acute gastric or intestinal spasm-like pain (without severe vomiting and surgical acute abdomen). 4. male or female patients aged 18 to 70 years. 5. the pain intensity upon screening is at least point 6 on a 0-10 numerical rating scale (nrs). exclusion criteria: 1. patients with the following concomitant disease is not eligible for enrollment: * painful gastric or intestinal spasm of organic origin such as crohn's disease, ulcerative colitis, lactose intolerance, gastrointestinal perforation, suspected gastrointestinal perforation or peritoneal effusion. * pain related with malignancy. * patients with other severe pain states of organic origin. * mechanical stenosis of the gastrointestinal tract ,megacolin. * urinary retention associated with mechanical stenosis of urinary tract. * narrow-angled glaucoma. * tachyarrhythmia. * myasthenia gravis. * meulengracht-gilbert syndrome. * known depression or known mental illness, anxiety disturbance. 2. patients taking the following concomitant medication within 7 half-life of concomitant medication (the duration from taking concomitant medication to attending the trial is less than 7 half-life) are not eligible for enrollment: * analgesics, * spasmolytics, * anticholinergics * affecting gastrointestinal motility, such as propantheline, metoclopramide, cisapride, loperamide, diphenoxylate, opioid analgesics, antacids and other ulcer treatment * regular administration of laxatives * narcotics * antidepressant treatment or treatment with psychoactive drugs 3. pregnancy and/or lactation or planned pregnancy; 4. known hypersensitivity to n-butylscopolammonium bromide 5. alcohol, or drug abuse. 6. simultaneous participating in another clinical trial, or discontinuing from another clinical trial before randomization (administration of study medication); moreover, in the case of screening failure or premature discontinuing from the trial, repeated enrollment is forbidden. 7. unwilling to or unable to complete the entire trial procedure according to the protocol. 8. in investigator's opinion, the patient is not proper for the trial.
managing breast cancer treatment: dyad's perspectives on treatment decision, financial and family burden.

Conditions: Breast Cancer

Summary: the purpose of this study is to understand the financial burden and treatment decisions, based on both of patient's and family's perspectives in breast cancer patients who receive systemic chemotherapy, targeted therapy or immuno-therapy and their family caregivers .

this study utilizes a cross-sectional survey and qualitative research design. data collection includes questionnaire surveys and recorded qualitative interviews. a total of 224 patients or family members who meet the criteria will be invited to participate in the study at oncology units and outpatient clinics. among them, 30 subjects, either patients or family caregivers will be invited to explore their experience on and concerns about financial burden and treatment decision making as facing breast cancer.

Eligibility criteria:
inclusion criteria: * breast cancer 1. patients with newly diagnosed or recurrent breast cancer who require chemotherapy or targeted immunotherapy as recommended by their physicians 2. age 20 to 70 3. within 0.5 to 3 years of newly diagnosed or recurrent breast cancer 4. ability to perform housework or wage employment before cancer 5. those whose cognitive function is sufficient to read newspaper news and answer questionnaires * breast cancer family 1. patient has been 0.5 to 3 years since the first diagnosis or recurrence of breast cancer and the doctor recommends chemotherapy or targeted immunotherapy 2. patient's self-reported family members who are involved in the patient's physical, social, or medical caregivers with cancer 3. age 20 to 65 4. able to perform housework or wage workers 5. those whose cognitive function is sufficient to read newspaper news and answer questionnaires exclusion criteria: * breast cancer 1. patients who were disabled before suffering from cancer 2. only undergoing surgery or hormone therapy * breast cancer family 1. persons with physical, mental and social disabilities 2. family members who are not involved in the patient's physical, social, or medical care for cancer

Keywords: breast cancer financial toxicity financial and family burden
phase iii clinical trial of "botulax®" to treat children with cerebral palsy

Conditions: Other Infantile Cerebral Palsy

Summary: to compare the safety and efficacy of botulax inj.®(botulinum toxin type a, hugel, south korea) with botox inj.® (botulinum toxin type a, allergan, usa) in the treatment of cerebral palsy in children.


Eligibility criteria:
inclusion criteria: 1. children patients ages from 2years old to 10years old. 2. patients who diagnosed with cerebral palsy. 3. patients who diagnosed as gross motor function classification system level i, ii, or iii 4. patients who diagnosed as dynamic equinus foot deformity 5. patients who agree with participation and signed to written agreement by substitute. (get a signature from children patients if possible)deformity and i, ii or iii level of gross motor function classification system exclusion criteria: 1. patients who had previous injection of other botulinum toxin products in 3 months 2. patients with hypersensitivity history to botulinum toxin products previously 3. patients with neuromuscular junction disorder (myasthenia gravis, lambert- eaton syndrome, or amyotrophic lateral sclerosis, etc.) 4. those who have severe cardiovascular, kidney, liver, or respiratory diseases 5. those who are taking anticoagulant drugs or have bleeding disorder. 6. pratients with treatment of following drugs: anticonvulsants, tranquilizers, narcotics, aminoglycoside antibiotics, muscle relaxtants like baclofen, blockers of parasympathetic nervous system, and levodopa. 7. patients who had history of surgery, plan to have surgery on legs, foot, or ankle. 8. patients who have evidence of fixed contractures regarding to investigator 9. patients who have difference between two legs over 5cm 10. patients with severe athetoid movement 11. patients who had other treatments related to dynamic equinus foot deformity, such as alcohol injection or muscle relaxants 12. those who were not enrolled in other studies within 30 days, or were not paseed over 5 times of half life for clinical trial drugs. 13. patients who have possibility to take prevented drugs 14. subjects who are not eligible for this study based on investigator's judgement

Keywords: other infantile cerebral palsy
reducing heavy drinking to optimize hiv/aids treatment and prevention

Conditions: Reduction in Heavy Drinking in Patients With HIV

Summary: this is a double-blind placebo-controlled study to evaluate the effect of naltrexone (ntx) and counseling on highly active antiretroviral treatment (haart) medication adherence in a cohort of hiv-infected patients who report heavy drinking, or meet criteria for alcohol abuse and/or dependence, and inadequate (\< 95%) haart adherence. all patients will receive a behavioral intervention, termed medical management/medication coaching or mm/mc. mm/mc incorporates the behavioral platform medical management (mm) from the national institute on alcohol abuse and alcoholism (niaaa)-funded combine study to reduce heavy alcohol use with medication coaching (mc), a manualized treatment designed to improve haart medication adherence in hiv-infected patients with substance use disorders.


Eligibility criteria:
inclusion criteria: 1. be hiv-infected. 2. currently be prescribed haart medication or be eligible to receive haart medication. 3. report less than 95% adherence to their haart medication. 4. report heavy drinking 4 or more times in the past 4 weeks, or meet current criteria for alcohol abuse or dependence. heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on one occasion. 5. be at least 18 years old. 6. be able to understand english and provide informed consent. exclusion criteria: 1. be psychotic or severely psychiatrically disabled. 2. be currently enrolled in formal treatment for alcohol (excluding self-help, e.g. alcoholics anonymous) 3. have medical conditions that would preclude completing or be of harm during the course of the study. 4. have laboratory or clinical evidence of significant liver dysfunction (alanine aminotransferase (alt) or aspartate aminotransferase (ast) greater than 5 times the upper limit of the normal range) or cirrhosis with a child-pugh classification greater than a or b. 5. have a known contraindication to ntx therapy (e.g. requiring opioid medication for pain). 6. be pregnant, nursing or unable to use an effective method of birth control (women). -

Keywords: substance abuse counseling adherence (medication) alcohol abuse highly active antiretroviral therapy (haart) naltrexone vivitrol hiv