Kornimate/medical-research-clean huggingface dataset:
first-line nab-paclitaxel plus cisplatin plus carilizumab in mtnbc patients

Conditions: Breast Cancer

Summary: to evaluate the efficacy and safety of nab-paclitaxel plus cisplatin plus carilizumab as first-line treatment in patients with metastatic triple-negative breast cancer.


Eligibility criteria:
inclusion criteria: 1. female patients aged 18-70 years who had 2. metastatic tnbc. er, pgr, and her2 status were determined locally by immunohistochemistry (ihc) of patient primary or metastatic tumor sections. metastatic disease was confirmed by clinical, imaging, histological or cytological measures. 3. patients were required to receive no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer. 4. patients who had received adjuvant/neoadjuvant therapy were required an interval for at least 6 months after stop of chemotherapy before the enrollment. 5. at least one measurable lesion according to recist 1.1, 6. ecog performance status ≤ 1 7. life expectancy of more than 12 weeks 8. adequate organ and bone marrow function. exclusion criteria: 1. patient of childbearing potential but unwilling to receive contraception. 2. radiation therapy of axial bone within 4 weeks before enrollment. 3. previous treatment with pd-1 antibody, pd-l1 antibody and ctla-4 antibody. 4. patients have active autoimmune diseases. 5. patients who need systemic corticosteroids (\> 10 mg prednisone/d) or other immunosuppressive drugs within 14 days before enrollment or during the study period. 6. symptomatic central nervous system (cns) disease (patients with asymptomatic treated cns metastases were permitted) 7. other malignant diseases within the past 5 years (patients with basal cell skin carcinoma and cervical carcinoma in situ were permitted) 8. uncontrolled infection.
3d-printed personalized metal implant in surgical treatment of ankle bone defects

Conditions: Bone Diseases

Summary: this study aims to use 3d-printed personalized metal implants for bone defect surgeries in order to reduce pain of the patients.

bone defects are common in ankle disease, and the conventional treatment includes autologous or allogeneic bone grafts. however, autologous bone graft may cause complications and its source is rather limited; allogeneic bone graft may cause disease transmission and the mechanical strength of the graft is low after processing. the 3d printing technology has provided a new way of solving this problem. it has the following technical advantages: wide range of graft sources, high mechanical strength, and can be prepared in advance according to various shapes. preparation procedure: first, establish the individualized ankle model according to the patient's ankle ct scan data and then prepare the implant model; second, conduct surgery rehearsal and place the implant model in the ankle model for observation; third, after confirmation, use titanium alloy in the 3d printing machine to prepare the individualized metal implant, which is in line with the chinese national standard "wrought titanium and titanium alloy for surgical implants" (gb/t 13810-2007); fourth, implant the individualized metal implant into the bone defect area after sterilization.

Eligibility criteria:
inclusion criteria: * receive ankle or subtalar arthrodesis; * refuse to use autologous bone graft or allogeneic bone graft. exclusion criteria: * the local defect area is small; * refuse to use permanent metal metal implant.

Keywords: 3d printing, metal implant, bone defect
kinetics and impact on survival of mrd in aml patients receiving azacitidine and venetoclax

Conditions: AML, Adult; Minimal Residual Disease

Summary: the goal of this no-profit, multicenter, biological, non-pharmacologic study is to evaluate minimal residual disease (mrd) in patients treated with azacitidine and venetoclax according to clinical practice. the main questions it aims to answer are: 1. kinetics of disease response on treatment with azacitidine and venetoclax through the evaluation of mrd with both cytofluorimetric and molecular techniques 2. impact of mrd on survival outcomes. to this end, bone marrow samples will be collected at pre-defined time-points during treatment and mrd will be assessed.

this is a multicentric biological study at evaluating mrd kinetics during treatment with azacitidine and venetoclax as well as the impact of mrd on survival outcomes. newly diagnosed, previously untreated, patients with aml, including de novo, secondary and therapy-related, receiving front-line therapy with azacitidine and venetoclax according to clinical practice will be included. response assessment will be performed on bm aspirate according to eln2022 response criteria. mrd evaluation will be performed on bm at pre-defined time-points during treatment. mrd assessment will be performed centrally in order to harmonize response evaluation.

Eligibility criteria:
inclusion criteria: * subject must be ≥ 18 years of age * subject has diagnosis of aml according to who 2016 * subject has newly diagnosed, previously untreated, aml, including de novo, secondary and therapy-related (cytoreduction with hydroxyurea is admitted prior treatment start) * subject is planned to receive front-line therapy with azacitidine and venetoclax * subject is ineligible for intensive induction chemotherapy according to investigator assessment according to clinical practice * subject must have assessable mrd by flow cytometry at screening bm evaluation * signed written informed consent according to ich/eu/gcp and national local laws exclusion criteria: * diagnosis of bcr::abl1-positive aml * diagnosis of apl * aml with cns involvement. * aml with extra-medullary localizations * patients' unwillingness or inability to comply with the protocol requirements.

Keywords: venetoclax azacitidine aml minimal rsidual disease
a post marketing surveillance study of doxazosin mesylate gits among filipino patients with benign prostatic hyperplasia (bph)

Conditions: Prostatic Hyperplasia

Summary: this study aims to assess the safety, tolerability and efficacy of doxazosin gits in filipino patients diagnosed with benign prostatic hyperplasia (bph) under the usual clinical care setting.

this is an open label study. all patients prescribed with doxazosin gits can be enrolled in this study.

Eligibility criteria:
inclusion criteria: * subjects that will be included must be consistent with the approved label indication of doxazosin mesylate gits in the philippines, which includes adult male diagnosed with bph, and who are prescribed with doxazosin mesylate gits. exclusion criteria: * subjects with condition that are contraindicated with doxazosin mesylate gits based on the approved labeling in the philippines.

Keywords: post marketing surveillance filipino benign prostatic hyperplasia bph doxazosin gits
safety and pharmacology of snx-5422 mesylate in subjects with refractory hematological malignancies

Conditions: Hematologic Neoplasms

Summary: hsp90 is a chemical in the body that is involved in the promotion of cancer. snx-5422 is an experimental drug that blocks hsp90. it is being evaluated for safety and efficacy in patients with cancer.


Eligibility criteria:
inclusion criteria: * \>18 years old * karnofsky performance status \> 60 * confirmed hematological malignancy * refractory to available therapy or for which no therapy is available * adequate hepatic, renal and hematological function exclusion criteria: * cns malignancy * at risk for prolonged qt interval * significant gi/liver disease * other serious concurrent illness or medical condition

Keywords: hematologic malignancies hsp90 hematologic malignancy
long term effects of soft splints on stroke patients and patients with disorders of consciousness

Conditions: Brain Injuries; Disorder of Consciousness; Stroke; Spasticity as Sequela of Stroke; Contracture; Hypertonic Disorder; Central Nervous System Diseases; Pathologic Processes; Craniocerebral Trauma; Trauma, Nervous System; Neurocognitive Disorders

Summary: the purpose of this study is to assess the effects on upper limb spasticity of soft splints worn during three weeks three hours a day by patients with stroke or disorders of consciousness.

patients with stroke or disorders of consciousness (doc) are likely to suffer from major muscular troubles such as spasticity. this spasticity may induce pain, loss in range of motion and permanent joint deformities. the aim of this study is to investigate the effects of soft splinting on the hand spasticity in both patients with stroke and patients with disorders of consciousness. the investigators plan to include 100 patients (50 stroke - 50 with doc) and each subgroup will be divided in two arms: one wearing real soft splints (6 cm diameter) three hours a day for 3 three weeks and the other one wearing 'placebo' splints (1 cm diameter). skin condition will be followed by the nursing team during the three weeks. spasticity, pain and consciousness assessments will be performed at baseline (week 0), after 1 week of treatment (week 1) at the end of the treatment (week 3), 1 week later (week 4), 3 weeks later (week 6) and three months later (week 12).

Eligibility criteria:
inclusion criteria (doc): * altered state of consciousness according to international criteria since more than three months * stable condition * ashworth score \> 1 for at least one upper limb joint exclusion criteria: * bone fracture/lesion at the upper limbs * serious neurological disorder (mmse \> 24) prior to the accident * botox injection on the upper limbs in the 6 months preceding the inclusion inclusion criteria (stroke): * central nervous system injury responsible for the spasticity * ashworth score \> 1 for at least one upper limb joint exclusion criteria: * bone fracture/lesion at the upper limbs * serious neurological disorder (mmse \> 24) * botox injection on the upper limbs in the 6 months preceding the inclusion
exercise and post-dry needling soreness

Conditions: Shoulder Pain

Summary: application of trigger point dry needling can induce post-dry needling soreness. this is not a negative experience, but sometimes some patients want to reduce it as much as possible. manual therapies and exercise strategies targeting to decrease post-dry needling soreness need to be investigated.


Eligibility criteria:
inclusion criteria: * unilateral non-traumatic shoulder pain * shoulder pain from at least 6 months * shoulder pain of more than 3 points on a nprs * presence of active trigger point in the infraspinatus muscle exclusion criteria: * bilateral shoulder pain * younger than 18 or older than 65 years * shoulder injury * upper extremity surgery * fibromyalgia syndrome * neck or shoulder surgery * cervical radiculopathy * whiplash * any type of intervention for the neck-shoulder the previous year

Keywords: trigger points disability post-dry needling soreness eccentric exercise
early development and diagnostic trajectories in dcd

Conditions: Developmental Coordination Disorder

Summary: the aim of this study is to map the early development of children with dcd and the diagnostic trajectory in flanders.

the diagnostic and statistical manual 5th edition (dsm-v) defines developmental coordination disorder (dcd) as early-onset deficits in acquiring and executing motor coordination skills. these deficits significantly interfere with the performance of activities of daily living and impact on academic productivity, leisure and play. although dcd can be identified during preschool, diagnosis generally occurs at primary-school age. before the age of three (t.i. infancy), some parents already express "something is wrong" with their child albeit dcd is rarely diagnosed within this age-group. knowledge on dcd in children before the age of five is limited. the aim of this study is twofold: to explore the early development of children with dcd and to map the diagnostic trajectory of dcd in flanders. design: a qualitative narrative inductive study design by means of audio-recorded in-depth interviews sampling: purposeful maximum variation sampling will be applied.

Eligibility criteria:
inclusion criteria: 1. parent or guardian of a child diagnosed with dcd 2. diagnosis of dcd within the last two years 3. child was max. 12y of age at the moment of dcd diagnosis exclusion criteria: 1. no severe diseases in early childhood greatly impacting development (cancer, severe accident,...) 2. diagnosis outside of belgium

Keywords: early development diagnostic trajectory parental report qualitative study
study to assess the efficacy and safety of cjm112 in patients with inadequately controlled severe asthma

Conditions: Asthma

Summary: an unmet medical need exists for patients with moderate and severe asthma who continue to demonstrate symptoms despite being on standard of care medications, and are not eligible for other biologic therapies developed or in development for t2-high(allergic/eosinophilic) asthma. the purpose of this study was to determine if cjm112, an anti-il-17a antibody, displayed the clinical efficacy and safety profile to support further development in patients with inadequately controlled moderate to severe asthma with low ige and low circulating eosinophil levels.

after an initial screening visit, run-in period and baseline assessments, the eligible subjects entered the treatment period and were randomized in a 3:2 ratio to one of the two treatment groups: * 300 mg cjm112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to week 12 (day 85) + standard of care treatment. * matching placebo + standard of care treatment. after completion of the last dose on day 85 of treatment period, subjects returned for the final efficacy assessment on day 92. following the treatment period, all subjects entered a 13-week safety follow-up period, including the end of study (eos) visit on day 176.

Eligibility criteria:
inclusion criteria: 1. patients with a physician-diagnosed history of moderate to severe asthma for a period of at least one year prior to screening. 2. patients on a stable therapy regimen of asthma for at least 3 months prior to screening with at least medium dose inhaled glucocorticoid and at least one additional asthma controller medication (such as inhaled long-acting bronchodilator, leukotriene antagonist, theophylline, stable low dose glucocorticoid, etc). 3. acceptable and reproducible spirometry with fev1 ≥ 40 and ≤ 90% of predicted at screening and baseline (re-testing is allowed once). 4. acq score ≥ 1.5 at screening and baseline (re-testing is allowed once). 5. total serum ige \< 150 iu/ml 6. peripheral blood eosinophils \<300/μl exclusion criteria: 1. previous use of biologics or other concomitant medications within the time periods specified in the som/protocol. 2. history of ongoing, chronic, or recurrent moderate or severe infectious disease. 3. patients who have smoked or inhaled nicotine or tobacco products within the 6 month period prior to visit 1 or who have a smoking history of greater than 10 pack years. 4. patients who have had an asthma attack/exacerbation requiring systemic corticosteroids for at least 3 continuous days within 4 weeks prior to screening. 5. patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to visit 1 or during the screening period. 6. women of child-bearing potential unless they use highly effective methods of contraception during dosing and for 13 weeks after stopping of investigational drug.

Keywords: asthma, allergic, eosinophilic, non-t2 high, allergy triggered asthma, reactive asthma, asthma attack, difficulty breathing
electroconvulsive therapy amplitude titration

Conditions: Major Depressive Disorder

Summary: this study is focused on advancing ect treatment for older adults with depressive disorders by refining neuromodulation stimulus parameters to improve efficacy and cognitive safety.

amplitude titration, as proposed in this current proposal, can reduce the variability related to fixed amplitude dosing and optimize clinical and cognitive outcomes. the goal of this project is to change standard ect parameter selection from a fixed amplitude to an individualized and empirically determined amplitude. to achieve this goal, the investigators will focus on the relationship between amplitude titration and treatment-responsive changes in hippocampal neuroplasticity with rul fixed amplitude ect. fixed amplitude ect results in variable e-field or ect dose. over the course of an ect series, the variable ect dose will result in inconsistent changes in hippocampal neuroplasticity. in contrast, pre-translational investigations have demonstrated that amplitude titration results in a consistent e-field or ect "dose". seizure titration amplitudes (based on historic data, 233 to544ma) are below the amplitude range of fda-approved ect devices (500 to 900ma) and will require an adaptor to reduce the output amplitude (investigational device exemption). amplitude titration will also be below the hippocampal neuroplasticity threshold and insufficient for antidepressant response. the difference between rul amplitude titration and rul fixed amplitude (800ma) ect will determine the degree of target engagement with the hippocampus. to illustrate, subjects with low amplitude titration of \~250 ma (800/250, high fixed/titration amplitude ratio) will have significant changes in hippocampal neuroplasticity. subjects with high amplitude titration \~500ma (800/500, low fixed/titration ratio) will have minimal changes in hippocampal neuroplasticity. the relationship between amplitude titration and fixed amplitude hippocampal neuroplasticity will be used to develop the amplitude multiplier required for consistent and clinically effective ect dosing.

Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder * clinical indications for ect with right unilateral electrode placement * right-handed * age range between 50 and 80 years exclusion criteria: * defined neurological or neurodegenerative disorder (e.g., traumatic brain injury, epilepsy, alzheimer's disease) * other psychiatric conditions (e.g., schizophrenia, bipolar disorder) * current drug or alcohol use disorder (except for nicotine); and 4) contraindications to mri.

Keywords: electroconvulsive therapy depressive episode cognition
resistance training and sleep in the elderly

Conditions: SLEEP DISTURBANCES Nec in ICD9CM

Summary: purpose: the objective of this study was to evaluate the influence of a session of resistance training on the sleep patterns of elderly people. methods: forty men aged 65 to 80 years, sedentary and clinically healthy were divided into two groups: the control group (n=18) and the resistance group (n=22). both groups underwent two polysomnography tests, one at baseline and another after either a resistance training session (one repetition maximum - strength test, resistance group) or without physical exercise (control group).

upon completion of the baseline polysomnography (psg), volunteers underwent body composition evaluations (total body mass, height and body mass index calculation) to characterize the sample. three familiarization sessions were conducted with the exercise machines used in the study, and one repetition maximum test (1 rm) was completed in order to quantify the training session load. a psg test was conducted on the same day of the exercise session for the resistance group, and the control group had a second psg without exercise to compare the groups at both times. the body composition assessment, the adaptations to the exercises and the training sessions were held at the center for psychobiology and exercise studies.

Eligibility criteria:
inclusion criteria: * male gender * sedentary lifestyle * age between 65 and 80 years * clinically good health (able to practice physical exercise) exclusion criteria: * known diseases of the cardiovascular, pulmonary, and musculoskeletal systems, diabetes * profession in the field of physical exercise * use of sleep medication * disqualification based upon the clinical examination
a retrospective study of the feasibility of ambulatory appendicectomy for acute appendicitis (based on data from the pmsi french national hospital information system) in the adults hospitalized between december 2013 and december 2014

Conditions: Appendicitis

Summary: acute appendicitis is a frequent surgical emergency, with an estimated incidence of about 80,000 cases a year (in france). it mainly affects young adults but is associated with a low complication rate and a short stay in hospital. ambulatory treatment is an innovative type of care in which the patient is hospitalized for less than 12 hours and does not stay overnight in hospital. ambulatory care is based on the guidelines issued by three french learned societies (the sfcd, the achbt and the afca) and has been defined by the french government as a national priority. the literature data show that 20% of patients undergoing appendicectomy for acute appendicitis can be treated on an ambulatory basis. however, the success factors for short-stay care (hospitalization \<24 hours) or ambulatory care (hospitalization \<12 hours) have yet to be identified. the investigators thus intend to perform a retrospective study of data from the pmsi french national hospital information system, in order to identify factors that are predictive of a length of hospital stay below 24 hours in patients having undergone appendicectomy for acute appendicitis during 2013 in france. the objective is to define the population of patients that could potentially benefit from ambulatory care.


Eligibility criteria:
inclusion criteria: medical criteria: * patients operated on for acute appendicitis between december 2013 and december 2014 sociodemographic criteria: * adult patients (aged between 18 and 75, inclusive) * social security coverage exclusion criteria: sociodemographic criteria: * patients under the age of 18 * pregnancy or breastfeeding * legal guardianship or incarceration

Keywords: acute appendicitis ambulatory appendicectomy
a phase i study to assess the pharmacokinetics of olorofim in subjects with renal impairment

Conditions: Renal Impairment

Summary: a single oral dose study to investigate the pk and safety of olorofim in subjects with severe renal impairment compared to subjects with normal renal function.


Eligibility criteria:
inclusion criteria: * male or female subjects 18 to 70 years of age inclusive, at the time of signing the informed consent. * body weight ≥50 kg and bmi within the range 18 to 35 kg/m2 (inclusive) * subjects with severe renal impairment (or end-stage renal disease who are not on dialysis) and with an egfr \<30 ml/min, estimated using the cockcroft-gault equation at screening and day -1 * subjects with normal renal function must be in good health, as determined by a medical history, physical examination, vital signs, 12-lead ecg, and clinical laboratory evaluations * subjects with normal renal function are matched by gender, age (±10 years) and bmi (± 20%) to at least one renally impaired subject. exclusion criteria: * subjects who have an abnormality in the 12-lead ecg that, in the opinion of the investigator, increases the risk of participating in the study * subjects with any history of convulsion (other than childhood febrile convulsion before the age of 6 years). * subjects who have any clinically significant allergic disease (excluding mild or seasonal allergies such as contact dermatitis or hay fever) as determined by the investigator. * subjects with a history of or any concomitant active malignancy. * subjects with a history of drug or alcohol abuse. * subjects with, or with a history of, any clinically significant neurological, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, ocular (including minor trauma), hematological, or other major disorders as determined by the investigator. * subjects with signs or symptoms consistent with a covid-19 infection at screening or day -1 * renally impaired subjects with kidney transplantation, or on dialysis