Kornimate/medical-research-clean huggingface dataset:
continue the same systemic therapy after local ablative therapy for oligo progression in metastatic breast cancer - the cosmo study

Conditions: Breast Cancer Invasive; Metastatic Cancer; Oligoprogressive

Summary: patients with oligoprogression of metastatic breast cancer during palliative treatment that is amenable to local therapy will be included. the local ablative therapy (lat) may consist of stereotactic ablative radiotherapy (sabr), also known as stereotactic body radiation therapy, surgery or radiofrequency ablation (rfa).


Eligibility criteria:
inclusion criteria: * histologically confirmed invasive breast cancer * metastatic breast cancer * oligoprogression defined as one or two distant metastatic lesions, limited to one organ, or the primary tumor or locoregional lymph nodes, increasing ≥20% in size and be larger than 15 mm or if metabolic activity increases (with 20% in suvmax) on fdg-pet-ct. * systemic treatment can be either endocrine, targeted, chemotherapy or immune-checkpoint blockade * patients should be on systemic therapy for at least six months. status should be stable disease or partial or complete response for at least 6 months. * oligoprogression has to be detected with radiological imaging comparing the lesion on the same type of imaging modality as has been used at the start of systemic therapy. * the radiological imaging that shows progression must be performed within 70days prior to lat. * bone metastases are classified as progressive if the lytic component of the lesion increases by ≥20% or the fdg-uptake increases by ≥20% on fdg-pet-ct * oligo-progression has to be confirmed with a fdg-pet-ct-scan 5-7 weeks after the initial scan that showed oligoprogression. * lesion(s) must be amenable to resection, radiotherapy or radiofrequency ablation with the intent of local obliteration * age ≥18 * world health organization (who) performance status 0 or 1 * signed written informed consent before patient registration according to ich/gcp, and national/local regulations exclusion criteria: * having received more than two lines of systemic therapy for mbc if a treatment regimen has been de-escalated without adding other therapies, this is seen as one line of therapy. for example: pertuzumab/trastuzumab+docetaxel followed by pertuzumab/trastuzumab will be viewed as one line of systemic therapy. * other malignancy except carcinoma in situ and basal-cell and squamous cell carcinoma of the skin, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy * current pregnancy or breastfeeding. women of childbearing potential must use adequate contraceptive protection * presence of any medical condition that would place the patient at unusual risk, up to the discretion of the clinician * presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
cmpa-go study: growth and safety outcomes in infants with cmpa fed a novel extensively hydrolyzed formula

Conditions: Cow Milk Protein Allergy

Summary: cmpa-go study: growth and safety outcomes in infants with cmpa fed a novel extensively hydrolyzed formula


Eligibility criteria:
inclusion criteria: 1. full term infant (gestational age ≥37 weeks and ≤42 weeks). 2. birth weight ≥2500 g and ≤4500 g. 3. infant aged ≥29 days (\>4 weeks) and \<5 months (≤22 weeks). 4. not breastfed at time of screening visit. 5. history of an immediate-type (ige-mediated) allergic reaction to a cow's milk-containing food or at least 2 persistent severe symptoms suggestive of delayed-onset (non-ige-mediated) cmpa. exclusion criteria: 1. prior use of ehf, hrf or aaf for more than 2 weeks before randomization. 2. demonstrated chronic malabsorption not due to cmpa. 3. history of anaphylaxis to cmp. 4. participants with a history of confirmed food protein-induced enterocolitis syndrome (fpies) or heiner syndrome. 5. any contraindication to the open ofc (eg. unstable respiratory disease), or any disorder in which epinephrine is contraindicated. 6. history of any immunotherapy for cmpa. 7. past or current disease or disorder which, in the opinion of the investigator or the sponsor either places the participant at risk because of participating in the study or may influence the results of the study, or the subject's ability to participate in the study.
clinical and radiological evaluation of acoustic neuromas with spontaneous shrinkage

Conditions: Neuroma, Acoustic

Summary: to evaluate the regression characteristics of this acoustic neuroma population using volumetric data to study the relationship between regression and clinical characteristics including tinnitus, dizziness, hearing loss, and the intrinsic characteristics of the patients.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * subject followed in radiology for the assessment or follow-up of neuroma between january 01, 2013 and june 30, 2018 * subject who has agreed to the use of his data for the purpose of this research * subject presenting an untreated neuroma exclusion criteria: * subject having expressed his opposition to participating in the study * subject followed for neuroma of other cranial pairs, * subject followed in the context of type ii neurofibromatosis * subject with a treated neuroma (radiotherapy or surgery)

Keywords: acoustic neuroma vestibular schwannoma spontaneous shrinkage neoplasm regression volume quantification tridimensional measurements volumetric measurements
immune modulation by exosomes in covid-19

Conditions: COVID-19; Critical Illness; Hypercytokinemia; Lung Fibrosis

Summary: following whole blood stimulation with mesenchymal stem cell derived exosomes, immune phenotype, cytokine release and mrna expression patterns from critically ill patients with covid-19 will be determined.

critically ill patients with covid-19 may develop lung failure and require extracorporal oxygenation due to hyperinflammation and progressive lung fibrosis. the anti-inflammatory and immune modulatory function of mesenchymal stem cells will be investigated by whole blood stimulation experiments using stem cell derived exosomes. exosome preparations have been characterized by mirna and protein expression patterns and suggest their tissue regenerative capacity. the hypothesis of the present study is that mesenchymal stem cell derived exosomes attenuate inflammation and support anti-fibrotic pathways.

Eligibility criteria:
inclusion criteria: * critically ill covid-19 patients with lung dysfunction * covid-19 who severity degree \>= 4, ards (who definition 13 march 2020) * body weight \> 50 kg * informed consent exclusion criteria: * pregnant or breast feeding women

Keywords: covid-19 critical illness hypercytokinemia exosomes mesenchymal stem cells tissue reconstitution immune modulation sepsis
multiphase optimization strategy (most) for treating pediatric post-traumatic stress disorder (ptsd)

Conditions: PTSD; Trauma; Pediatric ALL

Summary: the goal of this clinical trial is to test the extent to which different treatment components work to improve pediatric post-traumatic stress disorder (ptsd). it will also provide evidence for how these components work. the main research questions are: what are the effects of different components used to treat ptsd? what do these components change to produce benefits in ptsd? researchers will: compare components to a psychological placebo to estimate their effects and measure how they work examine how components work alone and in conjunction with other components participants will: receive different combinations of components and placebo attend weekly treatment sessions provide information to evaluate changes in ptsd


Eligibility criteria:
inclusion criteria: a child between the ages of 8-17 exposed to at least one dsm-defined trauma child assent for participation the participation of a caregiver with custodial rights to provide parental permission willing to participate in treatment delivery and respond to surveys meet ptsd diagnostic criteria that is the result of exposure to at least one of the identified traumas ability to read and understand english willingness to be randomized to an experimental condition placement in a stable caregiving environment for two months without an impending transition children currently taking psychotropic medications must have taken the medicine without dose adjustment for two months prior to study entry. exclusion criteria: psychiatric concerns requiring a higher level of care (e.g. suicidal ideation with intent; current psychotic disorder) an intelligence quotient (iq) \< 70 currently receiving a behavioral health intervention for concerns related to ptsd or pediatric trauma a participating caregiver who is a perpetrator of any identified trauma (e.g. sexual abuse) mri contraindicators (e.g. presence of metal in the body)

Keywords: ptsd trauma pediatric multiphase optimization strategy
feasibility of the mindfulness-based stress reduction intervention for black women living with hiv supplement

Conditions: HIV Infections; Mild Cognitive Impairment

Summary: in our supplement aim we will conduct a two-arm randomized pilot test of the adapted intervention compared to a usual care control group among 30 african american/black women with hiv (15/arm) to assess the feasibility and acceptability of the mindfulness-based stress reduction among women with hiv with mild cognitive impairment. feasibility will be assessed by our ability to (1) recruit, randomize, and retain participants and (2) deliver the intervention per the manual, as well as (3) participants adherence to home practices and assignments. acceptability will be assessed via qualitative data (focus group input regarding participants' satisfaction with the intervention and intent to continue using the practices), as well quantitative data (satisfaction survey).


Eligibility criteria:
inclusion criteria: * cisgender females * hiv seropositive * 18 years of age or older * english speaking * an active patient at the local hiv ambulatory clinic in alabama. * no history of neurological (including dementia diagnosis) * no history of severe psychiatric (e.g., schizophrenia or bipolar disorder) disorders exclusion criteria: * non-english speaking * appear temporarily impaired (e.g., intoxicated) * not willing to or legally unable to provide informed consent.

Keywords: hiv cisgender women african american or black mindfulness
clinical efficacy in relief of dyspnea by hvni: evaluation of new cannulae designs

Conditions: Dyspnea; Hypercapnia; Respiratory Insufficiency

Summary: this study will evaluate the ability of high velocity nasal insufflation \[hvni\] next generation nasal cannula designs to effect ventilation and related physiological responses relative to the conventional legacy cannula design.

the objective of this study is to evaluate the ability of hvni next generation nasal cannula designs to effect ventilation and related physiological responses relative to the current cannula design, with which there are published clinical outcomes data. it is hypothesized that next generation nasal cannula designs (prosoft and unicorn) will be comparable at relieving patient dyspnea while on hvni, when compared to the conventional (legacy) cannula.

Eligibility criteria:
inclusion criteria: * adults, 18 years or older * demonstrated severe dyspnea at baseline (borg rated perceived dyspnea \[rpd\] (scale 0-10) of 3 or higher) * severe baseline hypercarbia/hypercapnia of 50 mmhg or higher as measured by tcpco2 or arterial or venous blood gas exclusion criteria: * patient has unstable cardiovascular condition * significant unilateral or bilateral nasal occlusion * vigorous physical activity should not be performed within 2 hours of testing * inability to provide informed consent * pregnancy * known contraindication to perform steps of the protocol * absence of spontaneous respiration or known contraindication to hvni * inability to use nasal cannula and hvni therapy * agitation or uncooperativeness * determined by the clinician to be sufficiently unstable or unsuitable for this study
a study to evaluate the efficacy and safety of bimekizumab in the treatment of subjects with active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: this is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (tnfα-ir) subjects with active psoriatic arthritis (psa).


Eligibility criteria:
inclusion criteria: * subject is male or female at least 18 years of age * female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception * documented diagnosis of adult-onset psoriatic arthritis (psa) meeting the classification criteria for psoriatic arthritis (caspar) for at least 6 months prior to screening with active psa and must have at baseline tender joint count (tjc) \>=3 out of 68 and swollen joint count (sjc) \>=3 out of 66 * subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (ccp) antibodies * subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (pso) * subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (tnf(α)) inhibitors for either psa or pso * subjects currently taking nsaids, cyclooxygenase 2 (cox-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (mtx), leflunomide (lef), sulfasalazine (ssz), hydroxychloroquine (hcq) and/or apremilast can be allowed if they fulfill specific requirements prior to study entry exclusion criteria: * female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study * subjects with current or prior exposure to any biologics except tumor necrosis factor (tnf) inhibitors for the treatment of psa or pso * subject has an active infection or a history of recent serious infections * subject has known tuberculosis (tb) infection, is at high risk of acquiring tb infection, or has current or history of nontuberculous mycobacterium (ntmb) infection * subject has a diagnosis of inflammatory conditions other than pso or psa. subjects with a diagnosis of crohn's disease, ulcerative colitis, or other inflammatory bowel disease (ibd) are allowed as long as they have no active symptomatic disease at screening or baseline * subject had acute anterior uveitis within 6 weeks of baseline * subject has any active malignancy or history of malignancy within 5 years prior to the screening visit except treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer * subject has a form of pso other than chronic plaque-type (eg, pustular, erythrodermic and guttate pso, or drug-induced pso) * presence of active suicidal ideation, or moderately severe major depression or severe major depression * subject has a history of chronic alcohol or drug abuse within 6 months prior to screening

Keywords: psoriatic arthritis psa bimekizumab
physical activity and cognitive behavioural therapy in panic disorder and agoraphobia

Conditions: Panic Disorder; Agoraphobia

Summary: physical activity (treadmill) prior to in-vivo exposure supports the effect of cognitive behavioural therapy in patients with panic disorder and agoraphobia.

patients receive a 12-session manualized cognitive behavioural therapy, implemented over 7 weeks and followed by two booster sessions. five sessions consist of in-vivo exposures. prior to these sessions patients undergo a training of physical activity. half of the patients complete training on a treadmill at 70% of their maximal oxygen uptake while the other half complete training at 30%.

Eligibility criteria:
inclusion criteria: * subject familiarized with experimental procedure and had given written informed consent * diagnosis of panic disorder with agoraphobia according to diagnostic and statistical manual of mental disorders (dsm-iv) * score \>= 18 in hamilton rating scale for anxiety * score \>= 4 in clinical global index * reachability of patient for treatment and follow-up exclusion criteria: * dsm-iv axis i diagnoses of any psychotic disorder, bipolar disorder, current alcohol or drug dependence and axis ii borderline personality disorder * change in pharmacological treatment in the last 4 weeks * acute suicidality * medical contraindications for mild to moderate exercise training or exposure

Keywords: panic disorder agoraphobia physical activity
lumbopelvic fixation versus novel adjustable plate for displaced sacral fracture

Conditions: Reduction Deformity of Limb

Summary: patients of unilaterally displaced sacral fractures fixed with lumbopelvic technique or novel adjustable plate from june 2011 to june 2017 were recruited into this study and were divided into two groups: group a (lumbopelvic fixation) and groups b (novel adjustable plate). surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, reduction quality, related complications were reviewed. fracture healing was assessed by the radiographs conducted at follow-up. functional outcome was evaluated according to the majeed score at the final follow-up.

patients of unilateral displaced sacral fractures from june 2011 to june 2017 were recruited into this study. the inclusion criteria were as follows: 18-65 years, with normal activity ability before injury, fixed with lumbopelvic technique or novel adjustable plate, completed more than a year follow-up. the exclusion criteria were as follows: pathologic fractures, open fractures, associated with other severe injuries (traumatic brain injury), risk factors affecting bone healing (osteoporosis, smoking, and metabolic diseases) and non-completion of one-year follow-up. surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, related complications were reviewed. reduction quality was assessed on the postoperative radiographs and ct scans. functional outcome was evaluated according to the majeed score system at the final follow-up.

Eligibility criteria:
inclusion criteria: * 18-65 years, with normal activity ability before injury * fixed with lumbopelvic technique or novel adjustable plate * completed more than a year follow-up exclusion criteria: * pathologic fractures * open fractures * associated with other severe injuries (traumatic brain injury) * risk factors affecting bone healing (osteoporosis, smoking, and metabolic diseases) * non-completion of one-year follow-up
feasibility of tracheobronchial defect reconstruction using allogenic aortic patch

Conditions: Trachea Diseases; Airway Remodeling; Reconstruction Surgery

Summary: the investigators investigate the feasibility and safety of using cryopreserved aortic patches for tracheal or bronchial defect repair.


Eligibility criteria:
inclusion criteria: 1. congenital tracheal deformities: includes congenital tracheomalacia, congenital tracheobronchial malformations, complete tracheal rings, etc., with severe clinical symptoms and cases where treatment is recommended after evaluation. 2. acquired tracheal stenosis: includes tracheal narrowing caused by diseases, endotracheal intubation, or postoperative scar tissue, with severe clinical symptoms and cases where treatment is recommended after evaluation. 3. tracheal injury or tissue defect caused by trauma or burns: cases requiring surgical repair. 4. tracheal tumors: reconstruction of tracheal tissue following the removal of benign or malignant tumors. exclusion criteria: 1. patients who are unable to provide informed consent. 2. pulmonary tumors that can be treated with standard lobectomy. 3. locally invasive tumors that are unresectable. 4. presence of contralateral lymph node metastasis. 5. presence of distant metastasis, except for solitary, resectable brain metastasis. 6. tracheal lesions amenable to standard resection with direct anastomosis. 7. preoperative evaluation indicates inability to undergo standard lobectomy. 8. patients infected with human immunodeficiency virus (hiv) or with other immunodeficiency disorders. 9. any condition or circumstance deemed by the principal investigator to potentially interfere with the conduct of the trial (e.g., severely impaired cardiopulmonary function, significant liver or kidney dysfunction, poorly controlled diabetes, high-risk groups, or pregnancy). 10. individuals with concerns about the potential risks of the trial.

Keywords: cryopreserved aortic patch airway repair tracheal reconstruction bronchial reconstruction
gait training for individuals with paraplegia using the h-mex exoskeleton

Conditions: Spinal Cord Injuries; Paraplegia

Summary: this study evaluates the feasibility and effects of h-mex powered exoskeleton in individuals with paraplegia as a result of spinal cord injury.

participants with paraplegia will attend gait training using h-mex powered exoskeleton 3 times a week for 10 weeks. the aim of this study is to assess the impact of gait training using h-mex powered exoskeleton on walking ability, gait analysis, medical examination, body composition, functional evaluation, laboratory findings, quality of life, and subjective experience in individuals with paraplegia. participants will be evaluated before, during, and after training.

Eligibility criteria:
inclusion criteria: * neurologically stable paraplegia due to traumatic or non-traumatic spinal cord injury at least 2 months since injury * age more than 18 years * body weight less than 110kg, height between 160-180cm * sufficient postural stability to perform level transfer * sufficient upper extremity strength to use a walker or crutch exclusion criteria: * spinal instability * severe joint contracture in lower extremity * unhealed fracture in the major weight bearing bone in the lower extremity * skin compromise in areas of contact with the device * unresolved deep vein thrombosis * uncontrolled hypertension or hypotension * severe osteoporosis or osteoporotic fracture unable to gait training * lower extremity spasticity exceeding 3 out of 4 (modified ashworth scale) in any joint * upper extremity functional limitation due to weakness or contracture * psychological or cognitive problem that may limit the participants to understand instructions by investigator * any other issue that may interfere with the trial

Keywords: h-mex powered exoskeleton exoskeleton
the effectiveness of enough steroids as inducement therapy in minimal change disease-like iga nephropathy

Conditions: IgA Nephropathy

Summary: this is a single center,prospective,no-controlled clinical trial

1. the complete remission of enough steroids as inducement therapy in adult minimal change disease-like iga nephropathy patients 2. the safety of enough steroids as inducement therapy in adult minimal change disease-like iga nephropathy patients

Eligibility criteria:
inclusion criteria: * female or male patients aged between 18 to 65 years * renal biopsy was used to diagnose iga nephropathy * patients with 24h proteinuria 3.5g and serum albumin concentration lower than 30g/l exclusion criteria: * patients with serum creatinine ≥ 3 mg/dl or egfr \< 30ml/min per 1.73 m2 * urine rbc \> 1 million/ml * patients who have received treatment of enough steroids for more than 12 weeks * patients with secondary iga * patients who have impaired liver function,with alt/gpt or ast/got twice more than the normal upper limit or who have active hepatitis * patients with 2 type diabetes or obesity, whose bmi is more than 28kg/m2

Keywords: enough steroids mcd efficacy