Kornimate/medical-research-clean huggingface dataset:
brca1-associated dna repair dysfunction in patients with early triple negative breast cancer treated with neoadjuvant platinum-based chemotherapy

Conditions: Early Triple Negative Breast Cancer

Summary: the purpose of this study is to assess efficacy of platinum-based neoadjuvant chemotherapy in correlation with brca1-associated dna repair dysfunction in patients with early triple negative breast cancer.

recent gene expression profiling of breast cancer has identified specific subtypes with clinical, biologic, and therapeutic implications. the basal-like group of tumors is associated with aggressive behavior and poor prognosis, and typically do not express hormone receptors or her-2 ("triple-negative" phenotype). therefore, patients with basal-like cancers do not benefit from currently available targeted systemic therapy. there is a lot of evidence about a link between basal-like breast cancer and brca1 deficiency. many clinical characteristics and molecular features are shared by basal-like breast cancers and tumors that arise in carriers of brca1 germline mutations. some studies have indicated that brca1 mrna expression was lower in basal-like sporadic cancers than in controls matched for age and grade. brca1 is rarely mutated in sporadic breast cancers and, therefore, it is believed that this may be a result of epigenetic mechanisms such as acquired methylation of the brca1 gene promoter or a dysfunction in the pathways that regulate brca1 expression, such as overexpression of id4. the profound similarities between hereditary brca1-related breast tumors and basal-like tumors strongly implicate a fundamental defect in the brca1 or associated dna-repair pathways (p53, pten) in sporadic basal-like tumors. there is increasing evidence that the brca1-related dna-repair defects, especially defective homologous recombination, determines sensitivity to certain agents, such as platinum salts-based chemotherapy. the complexity in downregulation of brca1 expression suggests that these approaches may only be effective in the treatment of a subset of sporadic basal-like cancers. identification of specific markers for these cancers will be essential to translate an understanding of defective dna repair into targeted treatments for this poor prognosis subtype.

Eligibility criteria:
inclusion criteria: 1. female patients, age ≥18 years≤75; 2. histologically confirmed invasive er-, pr-, and her2-negative (triple- negative) adenocarcinoma of the breast; 3. clinical stage t1-2, n0-1, m0. exclusion criteria: 1. previous treatment for this breast cancer 2. history of malignancy treated with curative intent within the previous 5 years with the exception of skin cancer, cervical carcinoma in situ, or follicular thyroid cancer. patients with previous invasive cancers (including breast cancer) are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease 3. pregnancy or breast-feeding
immunogenicity, antibody persistence and safety of gsk biologicals' dtpa (infanrix) and dtpa (boostrix) vaccines.

Conditions: Acellular Pertussis; Tetanus; Diphtheria

Summary: to evaluate the immunogenicity, persistence of antibodies and reactogenicity of gsk biologicals' dtpa (infanrix) and dtpa (boostrix), when administered to subjects 18-20 months old, compared with not giving a booster dtp vaccine at 18-20 months. study double blinded for the two dtp vaccines and single blinded for the control arm.


Eligibility criteria:
inclusion criteria: * male or female children between and including 18 -20 months of age at the time of the vaccination. * completed a primary vaccination course with dtpa (infanrix) vaccine at 2, 4, and 6 months. * written informed consent obtained before study entry from the parents or guardians of the subject. * free of obvious health problems as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period. * evidence of previous or intercurrent diphtheria, tetanus, or pertussis disease, or of vaccination against any of these diseases since completion of the primary course of dtpa (infanrix) vaccine.

Keywords: boostrix infanrix
face-pc: family-centered care for older adults with depression and chronic medical conditions in primary care

Conditions: Chronic Medical Conditions; Depression

Summary: comorbid depression and multiple medical conditions in older adults are a serious public health problem. as an important facilitator of health-related activities, families are already involved in various aspects of self-management of chronic disease in older adults. despite the benefits they provide, informal caregiving activities currently are organized outside the medical system, which potentially creates redundant or misaligned efforts.the purpose of the mentored research is to examine the feasibility and acceptability of the face-pc, a theory-driven, multi- component, technology-assisted interdisciplinary team-based care model that systematically involves family in chronic disease management. it aims to optimize the patient and family's collective ability to self-manage chronic disease.

comorbid depression and multiple medical conditions in older adults are a serious public health problem. as an important facilitator of health-related activities, families are already involved in various aspects of self-management of chronic disease in older adults. despite the benefits they provide, informal caregiving activities currently are organized outside the medical system, which potentially creates redundant or misaligned efforts.the purpose of the mentored research is to examine the feasibility and acceptability of the face-pc, a theory-driven, multi- component, technology-assisted interdisciplinary team-based care model that systematically involves family in chronic disease management. it aims to optimize the patient and family's collective ability to self-manage chronic disease.

Eligibility criteria:
inclusion criteria for patient: * 60 years of age or older * receives primary care * phq-9 score ≥ 5 * must have at least one medical condition actively managed at the study site. inclusion criteria for family: * age 18 or older * identified as family by the patient * has a minimum of twice weekly total of 4 hour face-to face contact with the patient * is willing and available to participate in the study; * has access to internet. exclusion criteria for patient: * inability to understand screening and assessment questions * montreal cognitive assessment scores \<18 * known diagnosis of a severe chronic mental illness such as schizophrenia * meeting the criteria for bipolar disorder or schizophrenia in prime-md * deemed to be a danger to self or others that may require treatment outside a primary care setting. exclusion criteria for family: * institutionalized at the time of study.
transcranial direct current stimulation plus monoclonal antibodies acting on the cgrp pathway for migraine

Conditions: Migraine

Summary: electrophysiological changes that occur in the brains of migraine patients, lead to the activation of nociceptive centers, including a peripheral neural structure, the trigeminal ganglion (tg), which releases pain-inducing peptides and mostly calcitonin gene-related peptide (cgrp). monoclonal antibodies acting on the cgrp pathway (cgrp-mabs) are the first drugs specifically designed for migraine, they inhibit cgrp release from the tg without entering the brain. not all patients experience benefit from cgrp-mabs treatment. for this reason, associating these drugs with a non-pharmacological treatment that acts centrally, such as transcranial direct current stimulation, could be effective. the aim of the study is investigating how the migraine preventive treatment with cgrp-mabs in association with tdcs, is effective to reduce headache days, days of disabling headache, intensity of pain and consumption of acute treatments. migraine-related disability, quality of life, sleep disturbance and psychological aspects will also be evaluated. patients will be randomized into two groups, one will receive active tdcs and one sham tdcs. both patients and investigators will be blind to the treatment administered (double-blind). furthermore, will be evalutated the cortical mechanisms involved in migraine by directly modulating brain physiology via repetitive tdcs in patients with migraine on treatment with cgrp-mabs. to fulfill this aim, we will assess the eeg correlates of the actual effects of the stimulation in a sham-controlled study, providing the eeg indexes linked to the altered and potentially restored cortical dynamics in migraine.


Eligibility criteria:
inclusion criteria: * male or female patients, aged between 40 and 70 years, referring to the headache center of the university of l'aquila; * a diagnosis of migraine with or without aura according to the international classification of headache disorders, 3rd edition (ichd-3; https://ichd-3.org/); * age at onset of migraine \<50 years; * migraine must have been present for at least ≥ 12 months; * treated with cgrp-mabs (erenumab, fremanezumab or galcanezumab) according to clinical practice criteria for 90-180 days since the first subcutaneous administration (this time range was chosen to ensure a stable cgrp pathway inhibition); * reporting \>4 monthly migraine days in the last 30 days of observation despite treatment with cgrp-mabs; * able to discriminate between migraine and tension-type headaches; * written informed consent to participate in the study exclusion criteria: * any migraine preventive medication other than cgrp-mabs; * secondary migraine; * epilepsy or any other neurologic condition that may be worsened by transcranial electrical stimulation; * metallic head implants, cardiac pacemaker or any other device that could malfunction or be displaced by electrical stimulation; * pregnancy or lactation.
effect of three therapeutics strategies on patients with a chronic back pain (pluriclef).

Conditions: Chronic Low Back Pain

Summary: effect of three therapeutics strategies on the restriction of the participation of patients with a chronic back pain : multidisciplinary is it the key component ?

compare the efficacy of 1 year of participation, of three programs of care for patients with chronic law back, referred to specialists rehabilitation centers or directly to the multidisciplinary consultation of university hospital of angers. the primary objectif is to assess the efficacy of 1 year of the three therapeutics strategies with the number of days off work in the year following treatment.

Eligibility criteria:
inclusion criteria: * obtaining the signature of consent to participate in the study. * male or female, aged 18-55 years. * diagnosis of common chronic low back pain. * chronic low back pain that led to at least a month off work in the previous year or at least 3 months of stops in the previous 2 years. * employee and holds a permanent contract or a fixed-term contract in the public or private sector. exclusion criteria: * lack of consent to participate in the study. * no possibily to follow one of three programs of study * pregnant women, new mothers or mothers who are breastfeeding. * no affiliation to the french social system.

Keywords: chronic low back pain
esophageal cooling for af ablation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to determine if esophageal cooling using the attune medical esophageal heat transfer device (ensoetm) limits the number or seriousness of injury to the esophagus during atrial fibrillation ablation procedures. the ensoetm is an fda cleared device used for temperature management, but is not routinely used during atrial fibrillation ablation procedures.

the ensoetm is a non-sterile multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage. modulation and control of the patient's temperature is achieved by connecting the ensoetm to an external heat exchanger. two lumens connect to the external heat exchanger, while a third central lumen provides stomach access for connection to a fluid collection device with low intermittent suction for gastric decompression. the ensoetm is made of standard medical-grade silicone. it is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less. distilled water circulates within the ensoetm just like a water blanket.

Eligibility criteria:
inclusion criteria: 1. patients above the age of 18 years old. 2. patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo af ablation procedure. 3. patients must be able to understand and critically review the informed consent form. exclusion criteria: 1. patients whom are unable to provide informed consent. 2. patients with contraindication to egd. 3. history of prior af ablation procedures. 4. significant co-morbidities that preclude standard ablation procedure. 5. patient is ineligible for ensoetm placement due to: * known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia). * known ingestion of acidic or caustic poisons within the prior 24 hours. * patients with \<40 kg of body mass.
study to compare the effects of two dosages of tolvaptan in congestive heart failure patients

Conditions: Congestive Heart Failure

Summary: patients with congestive heart failure will be assessed for safety and clinical effects of tolvaptan 30 mg every day versus 15 mg twice a day over a period of 7 days.


Eligibility criteria:
history of chf

Keywords: chf
a mixed intervention to improve resilience for patient with neurocognitive disorders

Conditions: Cognitive Disorder

Summary: the study aims to test a program combining cognitive behavioral therapy techniques, positive psychology techniques, mindfulness meditation and yoga, in order to improve resilience in patient with minor cognitive disorder. this intervention will be compared to a control group, but also with a group testing another intervention (an intervention that does not improve resilience in the elderly, namely a "cognitive stimulation" intervention) in order to ensure that the effect potentially obtained is not due to the simple management of the participant. the duration of the intervention will be 3 months, with an evaluation directly before and after the intervention. in addition, in order to best evaluate the effectiveness of the interventions over time, two follow-up measurements will be proposed: a measurement one month after the intervention, then a final one three months after the intervention.


Eligibility criteria:
inclusion criteria: 1. man or woman aged \> 60 years 2. have a minor neurocognitive disorder according to the criteria of the dsm 5 3. score of 145 or less on the wagnild and young resilience scale (rs) (wagnild, 2009). 4. subject able to read and write french; 5. subject beneficiaries of a social security scheme; 6. ability to understand and sign free and informed consent. exclusion criteria: 1. subject already practicing meditation and/or yoga and/or tai chi 2. subject currently undergoing psychological therapy (whatever the approach) 3. subject with a major hearing, visual or motor disability likely to interfere with the proposed interventions or the performance of assessments; 4. presence and/or recent history (within the last 5 years prior to inclusion in the study) of major psychiatric disorders (e.g., schizophrenia, severe depression, addiction, bipolar disorders, psychotic disorders, risk of dissociation, panic attack, generalized anxiety disorder, etc.) 5. if taking psychotropic treatment, the dose must have been stable for 4 weeks 6. vulnerable persons are defined in articles l1121-5 to -8

Keywords: neurocognitive disorder resilience mixed intervention
a single-arm, blinded, fluorescent psma histopathology trial of as1986ns

Conditions: Prostate Cancer; Prostate Cancer (Adenocarcinoma); Fluorescence Imaging

Summary: a single-arm, blinded, fluorescent psma histopathology trial of as1986ns


Eligibility criteria:
inclusion criteria: * suspected prostate cancer warranting standard of care multi-core prostate biopsy exclusion criteria: * patients receiving same-day therapeutic lutetium-177 or actinium-225 psma receptor radiation isotope therapy treatment * patients with pre-existing, impaired or abnormal hepatic function, renal function, cardiac function, and abnormal elevated temperature * patients with a creatinine clearance cutoﬀ (crcl) of \< 60 ml/min

Keywords: fluorescent agent psma prostate surface membrane antigen histopathology fluorescence-guided surgery
outcome of stapes surgery in otosclerotic patients with tinnitus using tinnitogram

Conditions: Otosclerosis

Summary: this study will be conducted on patients with otosclerosis attending assiut university hospital and undergo stapedectomy operation evaluation of each patient will conducted preoperatively and 3 month postoperatively patient will undergo tinnitogram and tinnitus handicap questionnaire before and after the operation to measure improvement in hearing and tinnitus

otosclerosis is an abnormal bone remodeling in the middle ear the normal dense endochondral layer of the bony otic capsule in the labyrinth is replaced by irregularly laid spongy bone leading to the fixation of the stapes. * clinical otosclerosis is more prevalent in females than in males, giving rise to the hypothesis that sex hormones may contribute to the development of disease * the age of onset is variable, although hearing loss typically begins in the third decade, with a range from first decade to the sixth decade. in most cases, hearing loss is bilateral (70-85%) and is usually asymmetrical, developing initially in one ear before progressing to the other. positive family history of otosclerosis has been previously reported in between 30-70% of cases. the diagnosis is usually made clinically by * history * physical examination, * audiogram results(tinnitus handicap questionnaire arabic version, tinnnitogram ) most frequent presentation of patients with clinical otosclerosis is bilateral hearing loss and tinnitus between 65 and 87% of patient with otosclerosis experience tinnitus. most of them has unilateral tinnitus 83.3% , while only 16.7% reported bilateral tinnitus. patients with tinnitus often report that their tinnitus is associated with feelings of sadness, worry, frustration, and anger. these feelings can lead to difficulties sleeping, relaxing, and concentrating and may negatively impact relationships at work and impair participation in social settings . stapedotomy through sufficient air-bone gap closure data collection 1. full history taking 2. tinnitus handicap questionnaire arabic version 3. vital signs and general examination 4. full ent examination including ear canal and tympanic membrane examination 5. routine audiologic testing which provide an assessment of patient hearing 6. investigation 7. preoperative fitness 8. tinnitogra tinnitogram : tinnitus pitch match : we will start at 1000 hz and move up and down in frequency. tinnitus loudness match : patient threshold was determined at frequency of pitch matching, sound level will increase in small steps(1or 2 db ) until patient repoted that specific tone will just equal in loudeness to his tinnitus tinnitus handicap questionnaire arabic version

Eligibility criteria:
inclusion criteria: * patient with otosclerosis undergo stapes surgery in otorhinology department in assiut university hospital * all patient have tinnitus and conductive hearing loss or mixed hearing loss. exclusion criteria: * patient with otosclerosis who don't undergo stapes surgery patient have tinnitus due to causes other than otosclerosis.
juvenile rheumatoid arthritis research registry

Conditions: Juvenile Rheumatoid Arthritis

Summary: juvenile rheumatoid arthritis (jra) is the most common chronic inflammatory disease in children, and may be related to genetics. having two siblings who both have jra in one family is rare. the purpose of this registry is to collect patient information and blood samples from qualifying jra siblings and their families. the goal of the registry is to further understanding of jra as related to genetics.

jra is the most common chronic inflammatory pediatric rheumatic disease. jra may be related to a complex genetic trait. it is rare to have two or more affected siblings, or sibpairs, within one family. the jra asp (affected sibpair) registry is a nationwide effort and will collect information and blood samples from jra sibpairs and their families. unaffected family members (e.g., mother, father, and unaffected children) are also invited to participate. patients and their families may enroll in the registry in one of two ways: patients may contact the registry directly, or they may be referred to the registry through their physician. once the family has qualified to join the registry, the family will be asked to complete a questionnaire on the medical history of their jra-affected members. physicians of the jra-affected members will be asked to complete questionnaires about their patients' conditions. family members will also be invited to provide a one-time blood sample. information collected through the registry will help researchers identify genes involved in jra susceptibility.

Eligibility criteria:
inclusion criteria for patients and their families: * at least two members of a family diagnosed with juvenile rheumatoid arthritis (jra) * informed consent from the family indicating willingness to participate in the registry

Keywords: jra asps genomics
multiphasic prehab allo-hsct

Conditions: Leukemia

Summary: the purpose of this study is to implement a prehabilitation intervention to enhance recovery for people undergoing allogeneic stem cell transplant for hematologic malignancies. all participants in this study will receive a prehabilation intervention in addition to usual care (no change to their chemotherapy protocols or transplant) and several quality of life and fitness scores will be measured throughout the intervention.


Eligibility criteria:
inclusion criteria: * adult patients, 18 years or older, undergoing an allo-hsct for acute leukemia. * approval to engage in exercise as per screening by the csep or acsm certified cep and/or clinician * ability to provide written informed consent and understand study information. exclusion criteria: * less than 18 years old * diagnosed with acute leukemia but not undergoing work-up for allo-hsct * unable to read/communicate in english (i.e., unable to complete experimental procedures such as patient-reported outcomes). * neurological or musculoskeletal comorbidity inhibiting exercise. * diagnosed psychotic, addictive, or major cognitive disorders. * severe coronary artery disease (canadian cardiovascular society class iii or greater). * significant congestive heart failure (new york heart association class iii or greater). * severe thrombocytopenia (platelets \<10) - ok if transfused platelets prior to exercise.

Keywords: prehabilitation exercise allogeneic stem cell transplant
the analgesic efficacy of transversus abdominis plane block after laparoscopic cholecystectomy

Conditions: Laparoscopic Cholecystectomy

Summary: the purpose of this study is to determine whether transversus abdominis plane block as part of a multimodal postoperative regimen is superior to control in analgesic efficacy after laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: * laparoscopic cholecystectomy * asa 1-3 * bmi 18-35 * written consent exclusion criteria: * do not understand danish * drug allergy * pregnancy * alcohol or drug abuse * chronic pain with consumption of opioids * consumption of nsaid, cox2inhibitors or paracetamol within 24 hours before the investigation * infection at the needle site.

Keywords: transversus abdominis plane block, postoperative pain.