Kornimate/medical-research-clean huggingface dataset:
cd123/cll1 car-t cells for r/r aml (stphi_0001)

Conditions: Relapsed/Refractory AML

Summary: the treatment options for relapse/refractory b-cell acute myeloid leukemia(aml)are limited.cd123/cll1 car-t cells may have a permanent anti-tumor effect and became very attractive. this study aims to assess the safety and toxicity of cd123/cll1 car-t cells to patients with relapse/refractory aml.


Eligibility criteria:
inclusion criteria: * signed written informed consent * aged \< 70 years * patients with relapsed/refractory aml * cardiac: left ventricular ejection fraction ≥ 50% * adequate renal and hepatic function * performance status: karnofsky ≥ 70% exclusion criteria: * pregnant or lactating females. * any co-morbidity precluding the administration of cd123/cll1 car-t cells.
physical and emotional benefits of group dance intervention for breast cancer survivors

Conditions: Cancer

Summary: the purpose of this mixed methods study is to evaluate the effects an 8-week group dance intervention can have on body image and posture in breast cancer survivors.

the purpose of this mixed methods study is to evaluate the effects of an 8-week group dance intervention on body image and posture in breast cancer survivors. program description: an 8-week dance intervention was held at a local cancer support center in the greater philadelphia region. the study ran for 8 weeks, and each class was held once a week for 60 minutes. every class consisted of a 5-10 minute stretching warm up leading to approximately 50 minutes of teaching light choreography set to bollywood music. methods: this was a mixed methods study utilizing two quantitative assessments and a qualitative portion comprising of initial and exit surveys. breast cancer survivors were recruited from a local non-profit cancer support community in the greater philadelphia region. a sample of twelve women (n=12) fulfilled inclusion criteria of being diagnosed with and treated for breast cancer. dropout rate was low, and only 1 person fit this criteria. informed consent was sought after and obtained through the university of the sciences in philadelphia institutional review board. procedure: group dance intervention program lasted for 8 weeks in total with no control group. all twelve subjects participated in 60-minute dance sessions, once a week for 8 weeks. at the beginning and termination of this 8 week dance intervention, all subjects took a series of assessments including the body image scale (bis), postural assessment using the plumbline method, and initial and exit open-ended surveys to assess any additional benefits of the program. analysis: data review was completed through microsoft excel and sofa statistics (version 1.4.6), a free statistical analysis program (available online for download at www.sofastatistics.com). means and modes were found in demographics using excel. qualitative data was explored initially through reading surveys and noting repetitive points. survey data was coded by highlighting and labeling segments of common responses to survey questions. to ensure findings were consistent, an independent reviewer was employed to verify coded data. codes were later organized according to similarity to develop common themes. themes found from initial and exit surveys were studied closer using a comparative analysis, to look for connecting themes from initial and exit surveys.

Eligibility criteria:
inclusion criteria: * being diagnosed with and treated for breast cancer exclusion criteria: * participants who attended less than 6 classes

Keywords: posture body image dancing group survivors
international survey of acute coronary syndromes

Conditions: Acute Coronary Syndrome; Unstable Angina Pectoris; Myocardial Infarction; Coronary Disease

Summary: the international registry of acute coronary syndromes registry study (isacs) is both a retrospective and prospective study which was designed in order to obtain data of patients with acute coronary syndromes, and herewith control and optimize internationally guideline-recommended therapies in these countries

aims of this survey study are (1) documentation of the characteristics of all patients presenting to the isacs centers with stemi or nstemi (2) documentation of in-hospital outcome, and outcome rates at 6 month and 1 year, (3) documentation of invasive procedures and procedure-associated complications (4) documentation of therapeutic regimens and investigation conformity of treatment with already established guidelines. investigators: isacs administrative committee: raffaele bugiardini (italy-principal investigator) lina badimon (spain) olivia manfrini (italy- project coordinator) edina cenko (italy-center coordinator) steering committee: mirza dilic (bosnia and herzegovina), asen goudev (bulgaria), davor milicic (croatia), raffaele bugiardini, edina cenko and olivia manfrini (italy) gani bajraktari (kosovo), andrejs erglis and ilja zakke (latvia), remigius zaliunas and olivija gustiene (lithuania), sasko kedev and marija vavlukis (north macedonia), mihail popovici (moldova), maria dorobantu (romania), zorana vasiljevic (serbia), eva goncalvesova and martin studenkan (slovakia) , alexander n. parkhomenko (ukraine) , christopher p gale (united kingdom).

Eligibility criteria:
inclusion criteria: * acute coronary syndromes exclusion criteria: * under age or not able to give informed consent

Keywords: acute coronary syndrome, eastern europe, therapies
safety and effect of adipose tissue derived mesenchymal stem cells implantation in patients with critical limb ischemia

Conditions: Critical Limb Ischemia

Summary: the purpose of this study is to investigate the efficacy and safety of autologous transplantation of adipose tissue derived mesenchymal stem cells (mscs) in patient with critical limb ischemia


Eligibility criteria:
inclusion criteria: * at least 6 months since the onset cli(chronic aso or buerger disease) * patients with luminal stenosis \> 50% by leg angiography * age is between 20 and 80 * patients whose rutherford's class is ii-4, iii-5 or iii-6 (patients with rest pain or ischemic ulcer/necrosis) * patients for whom angioplasty and bypass surgery are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization * patients who can give informed consent themselves in writing exclusion criteria: * previous or current history of neoplasm or comorbidity that could impact the patient's survival * detection of proximal source of emboli including atrial fibrillation * primary hematologic disease, including hypercoagulable states * detection of proliferative retinopathy * entrapment syndrome * alcohol abuse, cocaine amphetamine etc. * detection of osteomyelitis * uncontrolled dm
computer-based intervention for alcohol-using hiv/hcv+ women

Conditions: Human Immunodeficiency Virus; Hepatitis C; Alcohol Abuse

Summary: the study harnessed the multidisciplinary expertise of our research team to develop a brief, computer-based, alcohol reduction intervention tailored for hiv/hcv co-infected women and evaluate its efficacy. the intervention, if effective, may be an efficient and cost-effective alcohol reduction strategy, that is scalable and can be readily disseminated and integrated in clinical care at other aids centres in russia to enhance women's health and reduce hiv/hcv transmission risk.

women co-infected with human immunodeficiency viruses (hiv) and hepatitis c (hcv) are at elevated risk for adverse health outcomes associated with alcohol use. evidence-based alcohol reduction interventions for this vulnerable population are limited. to address this gap, the study harnessed the multidisciplinary expertise and experience of collaborative russian-u.s. research team to develop a brief, computer-based, alcohol reduction intervention tailored for hiv/hcv co-infected women and evaluate its efficacy. the study was conducted in three sequential stages: (1) adaptation, (2) implementation, and (3) evaluation. participants will be randomized to one of two conditions: (1) adapted computer-based alcohol reduction intervention plus plus provider-delivered brief motivational counseling, or (2) provider-delivered brief motivational counseling. the trial design and analysis provide an appropriate conceptual and methodological framework to assess the efficacy of the computer-based intervention. the intervention, if effective, may be an efficient and cost-effective alcohol reduction strategy that is scalable and can be readily disseminated and integrated in clinical care at other aids centres in russia to enhance women's health and reduce hiv/hcv transmission risk.

Eligibility criteria:
inclusion criteria: * female; * receiving hiv medical care at the aids center; * chart-documented hiv and chronic hcv infection; * currently prescribed an antiretroviral (arv) regimen; * medically, cognitively, and psychologically capable of study participation; * laboratory-confirmed recent alcohol use as detected by a ethylglucuronide (etg) analysis or self-reported alcohol use exclusion criteria: * not identifying as biological female * not hiv and hcv positive * no laboratory-confirmed or self-reported * not willing to participate in the trial * not able to participate in the trial due to medical, cognitive, or psychological issues

Keywords: human immunodeficiency virus hepatitis c computer intervention alcoholism women russia
calcaneal osteotomy for intractable plantar fasciitis

Conditions: Plantar Fascitis

Summary: the aim of this study is to clarify the efficacy of plantar displacement calcaneal osteotomy for intractable plantar fasciitis by decreasing the tension of the plantar fascia around the calcaneal attachment while keeping the plantar fascia intact and comparing it with the plantar fascia release in pain control, job return and foot arch preservation.

plantar fasciitis (pf) is the most common cause of heel pain accounting for 15% of all foot symptoms requiring medical care and 1% of patient visits to orthopaedic surgeons in the united states. the diagnosis is straight forward; the challenge is finding an effective and economic first line treatment. the annual costs of plantar fasciitis are $284 million, that does not include opportunity cost from lost work and wages, societal burden, and psychologic burden. histologic examination shows myxoid degeneration with fragmentation and degeneration of the plantar fascia and supports being a degenerative fasciitis without inflammation. therefore, plantar fasciopathy is a more accurate descriptor. treatment is largely nonoperative, with 85% to 90% of patients experiencing resolution of symptoms within 6-12 months. partial or complete plantar fasciotomy, either open or endoscopic is indicated only for intractable cases with failed conservative treatment. fascia release, being the main surgery, sometimes accompanied by complications, one of which is lateral column pain due to loss of the longitudinal arch height caused by the release of the plantar fascia with no consensus regarding the amount of the plantar fascia which should be released in order to relieve pain without causing lateral column pain. to avoid this complication, we need to study the efficacy of calcaneal osteotomy for the surgical treatment of pf. does the calcaneal osteotomy is an effective alternative surgical treatment option compared to the standard plantar fascia release in cases of resistant pf?

Eligibility criteria:
inclusion criteria: * all adult patients with age range from 18 to 65 years with unilateral or bilateral pf after clinical and radiological diagnosis confirmation, who had failed conservative treatment for at least 6 months or recurrent cases after steroid injection exclusion criteria: 1. all other causes of heel pain including seronegative arthropathies, rheumatoid arthritis in bilateral cases, abscess or neoplasm affecting the soft tissue, and bone occult fracture or infection. 2. age groups below 18 years old and above 65 years old. 3. plantar fasciitis cases with pes planus.

Keywords: intractable plantar fasciitis heel spur anteromedial heel pain
the leadless av versus ddd pacing study

Conditions: Cardiac Pacemaker; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases

Summary: cardiac pacemaker (pm) implantation is the established treatment for relevant bradyarrhythmias. conventional pms require 1-3 pacing leads to register the heart's intrinsic activity ("sensing") and to deliver the electrical stimuli to the heart ("pacing"). these leads are responsible for the vast majority of morbidity after implantation and pm failures. therefore, a leadless pm system (micra tps™, medtronic, united states) has been introduced a few years ago. this system overcomes the limitations of leads, however, the first generation of the micra tps™ only allowed sensing and pacing in the right ventricle. more recently, an upgraded version has been introduced and gained market approval (micra av, medtronic, united states). according to published results from several clinical trials, this device allows sensing the atrial activity and, thus, timing the delivery of the ventricular pacing impulse in a physiological manner similar to a conventional dual-chamber pm with two leads. clinical feasibility and safety for this concept have been established already. however, it is unclear if this translates into a direct clinical benefit for patients in comparison to conventional pm systems. the aim of this trial is to compare the therapeutic efficacy of the micra av™ pm and conventional dual-chamber pm systems in patients with intermittent or permanent atrioventricular conduction block and a pm indication according to the latest european guidelines. thus, patients will be randomized to either a conventional dual-chamber pm implantation or the implantation of a leadless micra av™ system. patients will be stratified for gender (female/male) and a priori estimated physical exercise capacity ("fit"/"unfit"). the primary outcome will be the physical exercise capacity of the patients. the null hypothesis with regards to the primary endpoint is that the leadless pacemaker arm shows an inferior vo2 anaerobic threshold than the conventional pacemaker arm. hence the alternative hypothesis postulates that the leadless pacemaker arm shows a non-inferior vo2 anaerobic threshold compared to the conventional pacemaker arm. rejection of the null hypothesis is needed to conclude non-inferiority.


Eligibility criteria:
inclusion criteria: * patients (≥70y) undergoing a de-novo pacemaker implantation due to intermittent or permanent av block, qualifying for a conventional or leadless pacemaker * written informed consent exclusion criteria: * permanent atrial fibrillation or atrial standstill * evidence of sinus node disease and need for right atrial pacing (not possible with micra av) * lvef \<50% and permanent high-degree or total avb (requiring crt/his-bundle/csp pacing) * preoperative e/a ratio \>1.5 in the echocardiography * any co-existing icd indications (no leadless icd systems available) * hemodialysis * presence of a mechanical tricuspid valve prosthesis * unwilling or unable to comply fully with study procedures and follow-up

Keywords: leadless pacemaker atrioventricular conduction block bradyarrhythmias micra
multi-center study of iron overload: pilot study

Conditions: Sickle Cell Disease; Thalassemia; Diamond-Blackfan Anemia

Summary: the purpose of this study is to initiate pilot studies to demonstrate that a sufficient number of iron-overloaded thalassemia, scd and dba populations with similar duration of chronic transfusion, and age at start of transfusions would be available for a confirmatory study and to validate that proposed multicenter mri and biochemical studies can be completed. the study will examine the hypothesis that a chronic inflammatory state in sickle cell disease (scd) leads to hepcidin- and cytokine-mediated iron withholding within the res (reticuloendothelial system), lower plasma ntbi (non transferrin bound iron) levels, less distribution of iron to the heart in scd.

a detailed iron burden, transfusion and chelation history will be obtained from chart review or from participant recall. iron burden data will include: 1) documentation of liver iron, and 2) average annual ferritin values. transfusion data will include: (1) age at onset of regular transfusions, (2) years of chronic transfusion therapy, and (3) pre-transfusion hb calculated as average of all assessments for each year. mri will be performed measuring pituitary, cardiac, and liver iron. laboratory samples should be obtained pre-transfusion and mid-cycle. all interviews, exams, laboratory tests, study procedures and mri assessments should be completed within a 0 to 12 weeks time span. in addition, a healthy control group will also be recruited with similar age, gender, and ethnicity as the disease groups.

Eligibility criteria:
inclusion criteria: * 10-20 years of transfusion (defined as 0.2-0.6mg fe/kg/day exposure with annual ferritin levels greater than 2500 in at least 60% of years of chronic transfusion); * 0 to 9 years old at the initiation of chronic transfusions; no exchange transfusions in the previous 6 months * iron overload documented by either liver biopsy, mri or squid with estimated lic of greater than 7 mg/g dry wt in the previous 6 months or ferritin level greater than 1500mg/dl. exclusion criteria: * patients with hbsc, hbs/β thalassemia * pacemaker (active or inactive) or other implanted magnetic devices, severe claustrophobia, or other contraindications to mri; unable to remove ferro-magnetic objects from the body in regions to be imaged (e.g., jewelry or piercing) * presence of any other condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment; * any chronic inflammatory illness other than the scd, tm or dba; * any acute illness within a 14 day period prior to blood sampling; * patients receiving intensive chelation in the 6 months prior to enrollment including deferoxamine 24 hours per day, 7 days per week or combination treatment with 2 chelators * pregnancy
does graft improves the outcome tip repair for primary distal hypospadias?

Conditions: Penile Hypospadias

Summary: hypospadias is a common congenital anomalies in male children affecting 1 in 200-300 male births, the penis urethral opening is found ventrally, penile curvature and a lack of foreskin (1). multiple operations are described , tubularised incised-plate is the preferred option for distal hypospadias and with trial to extend the operation indication to proximal and redo hypospadias (2). its simple operative technique made tip repair gain worldwide acceptance in addition to the low complication rate \& good cosmetic outcome (3).it has several complication as stenosis meatus, fistula formation , uretheral stricture and failed repair (4). objective scoring systems were introduced to allow better judgment and identification of the postoperative results, depending on pre-operative and intra-operative criteria (5). modifications of the t.i.p operation was done to reduce complication and allow better results by using a graft , snodgraft vs snodgrass operation are nearly equal regarding the outcomes (6). to our knowledge there is no definite recommendation.


Eligibility criteria:
inclusion criteria: 1. children age more than 12 months to 12 years. 2. de-novo penile hypospadias after degloving of penis intraoperative (fresh, not previously operated) exclusion criteria: 1. circumcised 2. ventral penile curvature ≥30° after penile degloving \& artificial erection, (requiring transection of urethral plate). 3. uretheral plate less than 6mm 4. megameatus intact prepuce 5. albumin less than 3.5 g/dl
efficacy of intermittent tiotropium in early childhood wheezing

Conditions: Wheezy Bronchitis; Asthmatic Bronchitis; Wheezing; Obstruction Airway

Summary: this study evaluates the effect of intermittent tiotropium bromide and salbutamol as needed versus intermittent fluticasone propionate and salbutamol as needed, or solely, salbutamol as needed on episode-free days in infants and toddlers with recurrent episodes of wheeze and/or shortness of breath.

up to 30% of all children suffer from episodic wheeze or shortness of breath, i.e. asthmatic bronchitis, during the first three years of life. the condition is usually induced by viral respiratory infections, and short-acting beta-agonists are recommended as a monotherapy for symptoms unless there are at least four physician-confirmed episodes of wheeze or shortness of breath, or three episodes plus asthma risk factors. there is a current need for new therapeutic agents to treat asthmatic bronchitis in young children. in viral-induced wheeze, increased parasympathetic nerve activity results in increased acetylcholine release from nerve endings. tiotropium bromide, an inhaled anticholinergic agent, prevents the acetylcholine function and achieves mild bronchodilatation and decrease in mucus secretion from the submucosal glands. the aim of the study is to find out the effect of intermittent tiotropium bromide and salbutamol as needed versus intermittent fluticasone propionate and salbutamol as needed, or solely, salbutamol as needed on episode-free days in infants and toddlers with recurrent episodes of wheeze and/or shortness of breath. episode-free days are defined as those days during which there are no symptoms of wheeze and/or shortness of breath, no unscheduled medical visits for wheeze and/or shortness of breath, and no use of rescue or supplementary controller medications.

Eligibility criteria:
inclusion criteria: 1. children at the age of 6 to 35 months. 2. two to four physician-confirmed episodes of wheeze and/or shortness of breath. 3. parents/legal representatives with sufficient written and spoken skills in finnish language. exclusion criteria: 1. birth before 36th week of gestation. 2. suspected/diagnosed chronic parenchymal lung disease or a structural airway defect, or a history of thoracotomy with pulmonary resection. 3. a history of congenital or acquired heart disease, including any unstable or life-threatening cardiac arrhythmia. 4. constipation with a need of regular medication, or a diagnosed/suspected structural defect in the gastrointestinal tract. 5. a history of malignancy, or other significant chronic disorder, disease, or defect.

Keywords: wheeze shortness of breath
establish the couple intervention program for adults with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: the development of adult intimate relationships and the transition into couplehood are part of most people's life cycles, but these transitions become very challenging for individuals diagnosed with autism spectrum disorder (asd) in as much as social interactions, emotional communication, and reciprocity, which are essential for interpersonal relationships, are made more difficult due to the condition itself. in the adult asd clinic of national taiwan university hospital, we observe that the wives of the asd husband suffer from long-term frustration, loneliness and helplessness, and are frequently experience anxiety and depression, that in turns changes the family's function and impacts on children's mental health. to date, there are limited intervention models focusing on couple therapy for asd adults (or neurodiverse couple). given the strong needs of clinical service, this study aims to identify the common problems of the asd couples and develop a program to improve their partner relationships.


Eligibility criteria:
inclusion criteria: * one person of each couple has either autism spectrum disorder diagnosis or the autism spectrum quotient scoring above or equal to 26 * able to communicate in chinese * wechsler intelligence scoring above 70 exclusion criteria: * psychiatric disorder (i.e. schizophrenia, substance abuse) * unable to communication (i.e. visual or auditory impairment)

Keywords: autism spectrum disorder, couple therapy