Kornimate/medical-research-clean huggingface dataset:
study of onvansertib in combination with folfiri and bevacizumab or folfox and bevacizumab versus folfiri and bevacizumab or folfox and bevacizumab for first-line treatment of metastatic colorectal cancer in adult participants with a kras or nras mutation

Conditions: Metastatic Colorectal Cancer; CRC; KRAS/NRAS Mutation

Summary: the purpose of this study is to assess 2 different doses of onvansertib to select the lowest dose that is maximally effective, and to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of onvansertib in combination with folfiri + bevacizumab or folfox + bevacizumab in patients with kras or nras-mutated metastatic colorectal cancer (crc) in the first-line setting.


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic colorectal cancer. * documented kras or nras mutation. * no previous systemic therapy in the metastatic setting. * participants must be willing to submit archival tissue or undergo fresh biopsy. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * women of childbearing potential must use contraception or take measures to avoid pregnancy. * imaging computed tomography (ct) or magnetic resonance imaging (mri) of chest/abdomen/pelvis and other scans as necessary to document all sites of disease performed within 28 days prior to the first dose of onvansertib. * must have acceptable organ function exclusion criteria: * concomitant kras or nras and braf-v600 mutation or microsatellite instability high/deficient mismatch repair. * prior treatment with a vegf inhibitor, including bevacizumab or biosimilars. * previous oxaliplatin treatment within 12 months prior to randomization, when arm open. * known dihydropyrimidine dehydrogenase (dpd) deficiency. * anticancer chemotherapy or biologic therapy administered within 28 days prior to the first dose of study drug. * untreated or symptomatic brain metastasis. * gastrointestinal (gi) disorder(s) that would significantly impede the absorption of an oral agent. * unable or unwilling to swallow study drug. * uncontrolled intercurrent illness. * known hypersensitivity to fluoropyrimidine or leucovorin, irinotecan, or oxalipatin. * abnormal glucuronidation of bilirubin; known gilbert's syndrome. * use of strong cyp3a4 or cyp2c19 inhibitors or strong cyp3a4 inducers. * qtc \>470

Keywords: metastatic colorectal cancer kras mutation nras mutation crc first-line
optimisation of falls prevention after low-energy osteoporotic fractures: feasibility study

Conditions: Osteoporotic Fractures

Summary: within the groupe hospitalier paris saint-joseph (ghpsj), a reinforced medical care of osteoporosis ('fracture liaison service') was organized for osteoporotic fractured patients. the evaluation of benefits of this program through a randomized study showed an improvement in diagnostic tests performed (bone densitometry) and antiosteoporotic treatment initiated (optipost study, being published in bmj). however, of 323 patients included, 91 presented a new fracture within 12 months. among them, 40/126 patients (31.7%) were in the reinforced medical care arm. this result clearly demonstrates the need for a specific medical care program for patients with osteoporotic fracture falling regularly.

only few studies for secondary prevention of falls have been conducted in france yet. this can be partly explained by the complexity of reeducation programs to implement and by organization issues. moreover, to our knowledge, no study has demonstrated the benefit of such programs on secondary prevention of osteoporotic fractures, even though falls prevention is needed. our objective is to demonstrate with a pilot study the feasibility of a falls secondary prevention program, based on a rheumatology (ghpsj) and reeducation wards (hôpital sainte-marie paris : hsmp) collaboration. considering the innovative nature of both this program and this collaboration, a feasibility study is preferable before conducting a larger multicentric study, evaluating locomoter benefits of this program in comparison with usual primary care.

Eligibility criteria:
inclusion criteria: * men and women (age ≥ 60 years) * francophone * hospitalized patient or who is consulted in rheumatology or indicated for bone densitometry in groupe hospitalier paris saint-joseph, who are suffered a low-energy osteoporotic fracture in the last 12 months * patient with an acceptable handicap level definied by a timed up \& go test (tug) \<14 seconds * autonomous patient with instrumental activities of daily living score (4 items) = 0/4 and activities of daily living score (6 items) ≥5.5/6 * patient with medical insurance exclusion criteria: * history of locomor specialized care for the falls prevention * cognitive impairment/diagnosed dementia or chronic neurological disorder, which doesn't permit the undertanding or a follow-up to a rehabilitation program * fall due to a neurovascular disease or acute cardiovascular * significant comorbidities which don't permit a locomotor rehabilitation care * refusal to participate in the study * refusal to follow the entire rehabilitation program * geographic remoteness which doesn't permit the movement to the rehabilitation center * contreindicated balneotherapy: incontinence, skin disease or cardiovascular disease * patient under guardianship or curatorship * patient deprived of liberty
culturally aware aet non-initiation intervention

Conditions: Breast Cancer; Survivorship; Treatment Compliance; Treatment Adherence; Treatment Refusal

Summary: the purpose of this study is to examine the feasibility and acceptability of a brief, nurse-led intervention to support breast cancer survivors who have delayed initiation of hormonal therapy or who have concerns about starting hormonal therapy.

this is a single-arm pilot trial to examine the feasibility and acceptability of a patient-centered, evidence-based, culturally competent, nurse-led intervention to encourage breast cancer survivors who have not begun taking adjuvant endocrine therapy (aet) to initiate the medication. the research study procedures include: * screening for eligibility * two individual study intervention sessions * study assessment follow-up questionnaires this research study involves two individual sessions with a nurse practitioner which will take place via videoconferencing sessions either in-person or via telephone. participants will also complete three brief questionnaire packets over the 12-week course of the study. it is expected that up to 35 people will take part in this research study. the investigators plan to enrich the study sample for patients of a racial and/or ethnic minority in order to ensure the generalizability of the study findings.

Eligibility criteria:
inclusion criteria: * female * age 21 or older * diagnosis of early-stage (stage 0-iiib), hormone receptor-positive breast cancer * recommended to start aet at least 3 weeks prior and not currently taking aet or recommended to start aet in the future and reports hesitations to start aet as determined by a score of \>/= 4 (range =0-10) when asked "how hesitant are you about starting your recommended hormonal therapy? (0=not at all hesitant and 10 = extremely hesitant)" * ability to read and respond in english or spanish * eastern cooperative oncology group (ecog) performance status ≤ 2 * for at least 10 participants, identify as a member of a racial or ethnic minority community per self-report exclusion criteria: * uncontrolled psychosis, active suicidal ideation, psychiatric hospitalization within the past year * cognitive impairment that prohibits participation in the study * undergoing primary treatment for other cancer (i.e., advanced stage cancer) * participating in a clinical trial involving aet

Keywords: breast cancer survivors hormone therapy treatment refusal treatment compliance treatment adherence
a study of stavudine in hiv-infected patients who have not had success with other anti-hiv drugs

Conditions: HIV Infections

Summary: to make stavudine (d4t) available to patients with advanced hiv disease for whom no alternative antiretroviral is satisfactory. to study the safety and efficacy of two dose levels in a twice-daily regimen.


Eligibility criteria:
inclusion criteria patients must have: * hiv positivity with cd4 count \< 300 cells/mm3. * intolerance to or failure on approved antiretroviral therapy. * ability to provide informed consent (of parent or guardian if appropriate). note: * incarcerated persons may be eligible to participate. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * grade 2 or worse disease-related peripheral neuropathy. * unresolved drug-related peripheral neuropathy of any severity that is attributable to other nucleoside analogs (azt, ddc, ddi). * malignancy likely to require systemic chemotherapy with myelosuppressive or neurotoxic drugs in the first 3 months of stavudine treatment. * pregnancy (physicians of pregnant patients may contact bristol-myers to determine eligibility for stavudine therapy in another protocol). strongly discouraged: * azt, ddi, ddc, and other antiretroviral agents.

Keywords: acquired immunodeficiency syndrome aids-related complex stavudine
aflibercept injection into the vitreous body of the eye: study to learn more about patient relevant outcomes, real world treatment patterns and how well the treatment works for patients suffering from abnormal growth of new blood vessels under the retina.

Conditions: Macular Degeneration

Summary: in this clinical study researchers want to gain a deeper understanding of treatment consistence under real world conditions over the course of 24 months of aflibercept injections into the eye for patients suffering from abnormal growth of new blood vessels under the retina (neovascular age-related macular degeneration). the study aims to identify potential reasons that may allow classification of non-consistence as patient or physician driven. they want to describe treatment effectiveness (how well the treatment works) and associations between treatment effectiveness, non-consistence and patient relevant outcomes, such as vision specific quality of life and treatment satisfaction.


Eligibility criteria:
inclusion criteria: * diagnosis of neovascular age-related macular degeneration * decision to initiate treatment with intravitreal aflibercept was made as per investigator's routine treatment practice or current treatment with ivt-afl (all prior anti-vegf treatments must have been applied by the participating study site) * no participation in an investigational program with interventions outside of routine clinical practice * no contra-indications according to the local marketing authorization/ summary of product characteristics (smpc) * ability and willingness to participate in telephone interviews exclusion criteria: * any prior therapy with intravitreal steroids in the study eye. * concomitant therapy (except nutritional supplements) with any other agent to treat namd in the study eye * any prior transpupillary thermotherapy, photodynamic therapy, macular rotation/ translocation or macular laser in the study eye or * structural damage to the center of the macula in either eye * any other condition expected to permanently limit visual acuity outcomes over the course of the study

Keywords: neovascular age-related macular degeneration
retrospective study about primary biliary cholangitis during january 2001 to july 2016 at west china hospital

Conditions: Cholangitis; Liver Cirrhosis, Biliary; Cholestasis; Liver Diseases; Liver Cirrhosis; Bile Duct Diseases

Summary: retrospective study of all patients diagnosed with primary biliary cholangitis during january 2001 to july 2016 at west china hospital by review of medical records. the following variables will be retrospectively studied: age, sex, first symptoms, clinical characteristics, pathology, treatment, stage, complications of cirrhosis, other autoimmune diseases and long-term outcome.


Eligibility criteria:
inclusion criteria: * newly diagnosis of pbc at west china hospital during january 2001 to july 2016. exclusion criteria: * simultaneously diagnosed of autoimmune hepatitis or primary sclerosing cholangitis.
expre-son-rea : expressive own names in neurophysiologic assessment of comatose patients

Conditions: Comatose; Neurophysiologic Abnormality

Summary: evaluating the neurologic prognosis in disorders of consciousness (doc) patients is still a crucial issue in intensive care units. neurophysiology allows the investigators to record cerebral responses of patients to auditory stimuli and in particularly to their own name. numerous studies try to improve the relevance of the auditory stimuli used in this paradigm. here the investigators assess if the use of own name stimuli uttered by more expressive voices (for example smiling voices) modulates the cerebral responses recorded. they then correlate these cerebral responses to the neurologic prognosis at three months.

late auditory evoked potentials (as p3 wave) are used in neurophysiology to assess the level of consciousness in doc (disorder of consciousness) patients. the p3 wave, elicited by listening standard and deviant stimuli, corresponds to the activation of a frontoparietal network and is considered to reflect a cognitive attention task. using the own name of the patient as deviant stimuli improve the ability to detect the p3 wave because of the particularly relevance of this stimulus for the patient. however the correlation of this p3 wave and neurologic prognosis is still imperfect and depends on the etiology of the doc. in human cognition, to identify the expressivity valence of a voice is essential. neural processing of expressive voices involves more widespread brain areas than neutral voices processing. here the investigators assume that using own name stimuli uttered by more expressive voices (positive : smiling voice or negative : rough voice) should recruit more widespread brain areas and modulate the cerebral responses recorded. the investigators then evaluate if these cerebral responses are relevant markers of consciousness and correlate them to neurologic prognosis at three months.

Eligibility criteria:
inclusion criteria: * age over 18 * disorder of consciousness defined as : glasgow coma scale \ 8 but * eyes opening to pain only * no response to basic command * available neuro-imagery (ct-scan or mri) * normal temperature (no fever or hypothermia) * normal blood pressure during neurophysiologic evaluation * given consent from relatives exclusion criteria: * brain death * known deafness * severe sepsis uncontrolled during neurophysiologic evaluation

Keywords: doc patients erp (event related potentials) consciousness
slow versus rapid rehydration of severely malnourished children

Conditions: Diarrhea

Summary: the recommendation for correction of dehydration of severely malnourished children with diarrhoea includes oral rehydration and if parenteral rehydration is necessary (for example, in severe dehydration) to infuse intravenous fluids very slowly due to the concern of heart failure. there is not enough evidence to convince some of the physicians dealing with severely malnourished children with dehydrating diarrhoea (for example, cholera) that rapid rehydration per se is associated with increased incidence of over hydration and heart failure. and whether this approach is applicable in the management of severely malnourished children with severe cholera, which usually require rapid correction of water and electrolyte deficits for prevention of deaths due to hypovolaemic shock and other complications, has not been studied carefully. recently, we have demonstrated that rapid intravenous rehydration (within 4 to 6 hours) of severely malnourished children with dehydrating cholera replacing appropriate amount of fluid was found to be safe. we feel that rapid rehydration would help in improving the renal function, acidosis and thus improve appetite and reduce ors failure subsequently. since our study was uncontrolled, so we have planned a randomised controlled study with adequate sample of 250 participants; 125 will be rehydrated slowly (over 10 to 12 hours) following who guideline and 125 patients will be rehydrated with intravenous fluid over 6 hours. children of either gender, age 6 to 60 months, severely malnourished (wt for length \<-3 z score of who growth chart or with nutritional oedema) with a history of watery of \<24 hours with signs severe dehydration attending the icddrb dhaka hospital will be asked to participate in this study. after the parents'/legal guardian's consent, the children will be transferred to the study ward and will be treated according to the protocol. all children will receive similar treatment except the mode of rehydration, different for the two groups. the children will be closely monitored throughout the study period. the primary outcomes incidence of over hydration and ors failure and secondary outcomes improvement of renal function and improvement of appetite measured by the food intake will be compared between the groups.


Eligibility criteria:
inclusion criteria: 1. history of acute watery diarrhoea of \<24 hours. 2. either sex. 3. severe dehydration according to who guidelines 4. wt for length/wt for age \< -3 sd of who growth standard with or without oedema.(malnutrition) 5. consent given by the parents or legal guardian exclusion criteria: 1. bloody diarrhoea. 2. severe infection (e.g. severe pneumonia, clinical sepsis, septic shock, meningitis). 3. those who received antibiotics/antimicrobial for the current illness

Keywords: severe malnutrition severe dehydration cholera
a complex intervention study on a palliative rehabilitation blended learning program to support relatives and health care providers of people with als and cognitive impairments in coping with challenges

Conditions: Relatives; Health Care Providers; Cognitive Impairment; Rehabilitation

Summary: a complex intervention study on a palliative rehabilitation blended learning program to support relatives and health care providers of people with als and cognitive impairments in coping with challenges.

the projects concerns tree studies. 1. identifying experience-based evidence of relative of deceased people with als/cognitive impairments and health care providers (working with these persons) and develop an intervention program. 2. developing a palliative rehabilitation blended learning program for relatives of people with als and cognitive impairments and for the health care providers. 3. feasibility testing of the two palliative rehabilitation blended learning programs for relatives and health care providers. though online palliative rehabilitation the intervention aims to support both relatives of people with als/cognitive impairments and health care providers in coping with challenges related to the diseases. the intervention consists of blended learning through online videos and virtual group meetings, where peer-support play an essential role. the videos consists of a psycho education, mindfulness based stress reduction, relationship changes, intimacy, sorrow and grief, control management, planning the future, how to communicate, hope, creating memories, external support offers. besides the videos and group meetings, the relatives are given the possibility to make ecomaps and diary reflections.

Eligibility criteria:
inclusion criteria: relatives * relatives (spouse or partner) living with a person with als and cognitive impairments (rated on the als-ftd-q by the relative, cut-off \>22) able to talk and understand proficient danish referred to the national rehabilitation center for neuromuscular diseases and have had a visit from an als-consultant exclusion criteria: -

Keywords: relatives, informal carer, family carer als/mnd cognitive impairment palliative rehabilitation blended learning online support, telehealth, e-learning peer-support health care providers
clinical evaluation of silk'n glide for face

Conditions: Hirsutism

Summary: this is a clinical study to determine the efficacy and safety of the glide, hair removal photo-depilation device, for removing facial hairs. during the first stage, the subjects will perform up to 6 face treatments, two weeks apart. the treatment's safety and efficiency will be evaluated at 4 weeks of after last treatment and at 12 weeks after last treatment.

study efficacy assessment: comparison of hair counts before treatments to 4 and 12 weeks follow up visits. study safety assessment: 1. reported errors and near errors using the device 2. device malfunctions which relate to device safety 3. device related adverse events 4. non device related adverse events (secondary endpoint)

Eligibility criteria:
inclusion criteria: 1. presence of unwanted hairs on the face 2. skin type i to iv (fitzpatrick) 3. adults older than 21 years of age but not more than 60 years of age. 4. must be either post-menopausal or surgically steri-lized, or using a medically acceptable form of birth control (i.e., oral contraceptives, iud, contraceptive implant, barrier methods with spermicide or absti-nence). 5. informed consent agreement by the subject. 6. willingness to follow the treatment schedule and post treatment care. exclusion criteria: 1. malignant or pre-malignant pigmented lesions in the area to be treated. 2. scarring or infection of the area to be treated. 3. known photosensitivity. 4. pregnancy or lactating 5. subjects with diabetes (type i or ii). 6. presence of a suntan in the area to be treated. 7. use of medication known to induce photosensitivity. 8. subject is on anticoagulative medication or throm-boembolic condition. 9. subjects with a pacemaker or internal defibrillator. 10. use of nsaids two weeks prior to, and two weeks following the treatment. 11. subjects that use waxing or other methods of photo-epilation 3 months prior to treatment. 12. subjects that have been exposed to strong sunlight or an artificial tanning machine during the past 4 weeks 13. subjects wearing a tattoo or permanent makeup on the area to be treated 14. subjects with dark brown or black spots, such as large freckles, birth marks, moles or warts on the area to be treated 15. subjects with eczema, psoriasis, lesions, open wounds or active infections, such as cold sores in the area to be treated 16. subjects with history of keloidal scar formation 17. subjects with history of herpes outbreaks in the area of treatment, unless you have consulted your physician and received preventative treatment before using glidetm 18. subjects with epilepsy 19. subjects using incontinence device, insulin pump, other active devices \[nb: protocol excludes pace-makers and internal defibrillators.\] 20. subjects with a history of skin cancer or areas of po-tential skin malignancies 21. subjects who have received radiation therapy or chemotherapy treatments within the past 3 months

Keywords: at home photo depilation device, silk'n.
rws of inetetamab her2 positive advanced breast cancer

Conditions: HER2-positive Advanced Breast Cancer

Summary: this non-interventional study will describe and analyze the clinical use of inetetamab in clinical practice in the treatment of her2 positive advanced breast cancer in the real world.


Eligibility criteria:
inclusion criteria: 1. patients with stage iv breast cancer 2. patients with her2 positive status 3. patients that received inetetamab 4. patients that began inetetamab therapy prior to june 30, 2021. exclusion criteria: patients treated with an investigational anticancer agent inetetamab