Kornimate/medical-research-clean huggingface dataset:
treatment of iron deficiency anaemia in pregnancy study

Conditions: Anemia, Iron Deficiency

Summary: the burden of anaemia remains unacceptably high during pregnancy. over a third of women are anaemic by their third trimester of pregnancy. the most common cause is iron deficiency. one key factor is rising iron requirements throughout pregnancy. there are risks associated with anaemia for the mother and infant. anaemia in the first and second trimester has been significantly correlated with low birth weight and pre-term birth, and is associated with impaired neurological development of the baby. it also increases the risk of intrauterine fetal death, and the likelihood of the mother requiring blood transfusions during or after delivery.this study is a prospective cohort study, which aims to better define the natural history and understand how to use oral iron therapy for iron deficiency anaemia in pregnant women. this includes documenting the impact of treatment on anaemia symptoms, side effects, and the level of success of iron therapy using several haematological tests. pregnant women will be invited to participate in this study and treated using a treatment schedule as described in national guidelines. additional blood samples will be taken for subsequent detailed analysis of pathways of iron metabolism to better predict the response to oral iron therapy during pregnancy.


Eligibility criteria:
inclusion criteria: * pregnant women (any stage during pregnancy up to 36 weeks) and women in the puerperium (within 6 weeks postdelivery) with anaemia as defined by world health organization (who) criteria and described in british society haematology (bsh)/ british committee for standards in haematology (bcsh) guidelines. 1. first trimester \< 110g/l 2. second and third trimester \< 105g/l 3. puerperium \< 100g/l * age: 18-45 years * agreement to participate in the study with consenting exclusion criteria: * anaemic women presenting at or after 36 weeks as there may be insufficient time to delivery to assess responses to oral iron) * anaemic women affected by a (major) haemoglobinopathy e.g. b thalassaemia major sickle cell disease * women with overt clinical signs of sepsis * allergies to iron * hyperemesis gravidarum / persistent vomiting * women with inflammatory conditions such as crohns, ulcerative colitis, systemic lupus erythematosus, rheumatoid arthritis. * women with chronic renal failure
clinical study of asn-3186 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a phase i/iia, open-label, multi-center, dose-escalation, and expansion study to evaluate the safety, tolerability, pk and preliminary anti-tumor activity of asn-3186 when given orally in subjects with advanced solid tumors


Eligibility criteria:
key inclusion criteria: 1. males or females aged ≥ 18 years at time of signing informed consent form (icf). signed icf must be obtained before the performance of any protocol-specified procedures. 2. life expectancy ≥12 weeks evaluated by investigator. 3. ecog performance score 0 to 2. 4. histologically or cytologically confirmed advanced solid tumors defined as unresectable locally advanced or metastatic and do not have standard treatment available, or have disease progression on/after standard treatment, or cannot tolerate standard treatment. 5. for phase ia subjects: subjects who have confirmed deleterious or suspected deleterious germline or somatic brcam, or hrrm, or hrd positive or other alterations are preferred, but gene alteration state is not mandatory as an inclusion criterion and no need to wait for biomarker detection results before enrollment. 6. for phase ib subjects: subjects must have confirmed deleterious or suspected deleterious germline or somatic brcam, or hrrm, or hrd positive or other alterations. 7. for phase iia subjects: subjects must have confirmed deleterious or suspected deleterious germline or somatic brcam, or hrrm, or hrd positive or other alterations. key exclusion criteria: 1． treatment with any of the following: 1. . prior treatment with any usp1 inhibitors. 2. . prior treatment with radiotherapy, chemotherapy, targeted therapy or endocrine therapy within 4 weeks prior to the first dose of asn-3186. 3. . participated and received investigational therapy or used an investigational device or participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks or 5 × t1/2, whichever is longer, prior to the first dose of asn-3186. 2．subjects who expect to require any other form of anti-tumor therapy during the treatment period. 3． subjects who have unresolved toxicity greater than common terminology ctcae v5.0 grade 1 from prior anti-tumor therapy prior to the first dose of asn-3186, except for alopecia and chemotherapy-induced peripheral neurotoxicity ≤ ctcae v5.0 grade 2. 4． subjects who have undergone surgery on vital organs (other than aspiration biopsy) or suffered major trauma within 4 weeks prior to the first dose, or subjects who have not recovered from any surgical effect at screening, or subjects who are scheduled for major surgery during the study period. 5． subjects who have gastrointestinal disorders that will affect oral administration or affect the absorption of asn-3186 as judged by the investigator. or subjects who have severe or clinically significant gastrointestinal disease (e.g., refractory diarrhea, intractable vomiting, colitis, etc.) within 4 weeks prior to the first dose of asn-3186 and did not recover to ctcae v5.0 grade 1.
third national registry of acute coronary syndromes

Conditions: Acute Coronary Syndromes

Summary: the registry pretends to identify stratification, diagnosis and treatment approaches in patients with acute coronary syndrome (acs) in community hospitals with tertiary hospitals to optimize resources and identify strategies to improve health care quality through the creation of clinical guidelines that serve for unify management and treatment methods with adherence to international guidelines which include suggestions for treatment and medication.


Eligibility criteria:
inclusion criteria: all patients with suspected acs and will analyze risk factors, chest pain and electrocardiographic characteristics. exclusion criteria: patients with secondary ischemia (anaemia, pulmonary thromboembolism, myocarditis) and type ii infarction.
biomarkers for predicting the response to inhaled corticosteroid in patients with chronic cough.

Conditions: Cough

Summary: to investigate the value of blood eosinophils, feno and total ige in predicting the response to inhaled corticosteroid in patients with chronic cough.

chronic cough is a frequent complaint in respiratory specialists clinic. cva, uacs, eb, gerc and ac are common causes of chronic cough, among whom, cva, eb and ac can be classified as corticosteroid responsive cough. to recognize the eosinophilic airway inflammation and assess the response of inhaled corticosteroid, induced sputum analysis is the most widely used examination but not all the subjects can provide an suitable sample of sputum for measurements and it's time-consuming. recently, blood eosinophils, feno and total ige were detected to be biomarkers of eosinophilic airway inflammation for asthmatics. however, whether can they predict the response to corticosteroid in chronic cough remains uncertain. the present prospective, multi-center, randomized placebo-controlled study aims to explore the value of blood eosinophils, feno and total ige in predicting the response to inhaled corticosteroid in patients with chronic cough.

Eligibility criteria:
inclusion criteria: 1. age: 18-70 years; 2. coughing lasting ≥ 8 weeks； 3. no abnormality in chest imaging in the past 3 months (or there is abnormality but the investigator judges it not the cause of chronic cough)； 4. fev1% pred\>70%；fev1/fvc\>70%； 5. vas≥30 in the past 48 hours; 6. non-smokers or patients smoked less than 10 pack-years; 7. candidates voluntarily participate in and abide by the relevant regulations of the study, can cooperate with corresponding inspections, follow the follow-up plan, and voluntarily sign written informed consent. exclusion criteria: 1. patients received inhaled or oral corticosteroids or leukotriene receptor antagonist in previous 4 weeks; 2. patients with history of upper respiratory tract infection in the past 8 weeks; 3. patients taking angiotensin-converting enzyme inhibitors in previous 8 weeks; 4. female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study; 5. combined with a definite history of pulmonary diseases such as bronchiectasis, pulmonary interstitial disease, and pulmonary hypertension. combined with other serious diseases (such as cardiovascular system diseases, metabolic system diseases, immune system diseases, nervous system diseases, etc.) that may affect the normal process of this study; 6. participating in other drug clinical trial projects.

Keywords: chronic cough biomarkers
the effect of remifentanil on rebound pain

Conditions: Pain, Postoperative

Summary: the investigators will evaluate the influence of intraoperative remifentanil infusion on the postoperative hyperalgesia in patients receiving rotator cuff repair after brachial plexus block for postoperative analgesia.

the study will include 68 patients undergoing rotator cuff repair. all patients will receive brachial plexus block for postoperative analgesia, followed by general anesthesia. in the experimental group, remifentanil infusion will not be used intraoperatively, and in the control group, remifentanil will be infused. after surgery, both groups will be given the same postoperative pain management using patient controlled analgesia(pca), and pain patterns will be assessed using the numerical rating scale (nrs) at 4 hour intervals for 24 hours. the primary end point of this study is the total dose of pca medication over 24 hours.

Eligibility criteria:
inclusion criteria: * asa class i,ii,iii * patients undergoing arthroscopic rotator cuff repair surgery under general anesthesia after interscalen brachial plexus block for post operative analgesia * age ranges from 20 to 70 exclusion criteria: * patients who didn't agree to study * patients can't control pca(patient-controlled-analgesia) independently * patients who have conciousness disorder or can't express their pain level by nrs(numeric rating scale) system * patients who have severe respiratory disease or hepatic failure * patinets who have known neuropathy or coagulopathy * pregnancy * patients with allegies to the drugs used in this study

Keywords: hyperalgesia brachial plexus block remifentanil
software for alternative communication

Conditions: Speech Impairment

Summary: the aim of this study is evaluate a software developed for alternative communication designed for people with speech difficulties. the software was executed by 30 volunteers using mobile devices that helped to play the scenarios simulated of communication situations.

communication is a fundamental element that contributes to the development of the human being, promoting their coexistence in society. however, several factors, among them the cerebral palsy (cp), can cause changes in muscle tone, causing injury in phono-articulatory which prevent or impair the speech production. this research aims to the development of a mobile application to promote the augmentative and alternative communication for people with cp, which adapt to the characteristics of motor limitations of these users. a mobile application was developed with pictographic resources and a voice synthesis engine, which can be customized according to the level of motor impairment and need for communication of the user. were recruited 30 volunteers with cp who have speech difficulties and motor impairment. by means of a test script, these volunteers have used the mobile application and evaluated their usability using the questionnaire system usability scale (sus), which contains 10 questions related to the ease of learning, efficiency, ease of memorization, occurrence of runtime errors of execution and level of user satisfaction.

Eligibility criteria:
inclusion criteria: * cerebral palsy and speech disorder exclusion criteria: * visual impairment and / or severe cognitive impairment

Keywords: mobile devices augmentative and alternative communication cerebral palsy
classifying and predicting long-term pain and function in older adults

Conditions: Chronic Pain; Pain

Summary: this project will use novel methods to detect clinically meaningful subgroups of older adults based on long-term trajectories of bothersome pain and function. it will then identify older adults at high risk of experiencing poor long-term pain and function. anticipated results will provide new insights into long-term patterns of pain and function across the aging process and identify potential predictors of each trajectory.

the long-term goal of this planned line of research is to reduce the burden of pain and maximize function in older adults as they age. this line of research will begin by completing the following aims: aim 1) identify and describe clinically meaningful long-term trajectories of bothersome pain and functional decline in a population-based sample of older adults and aim 2) estimate the association between candidate prognostic factors typically available in electronic health records and long-term bothersome pain and function trajectories to inform the development of eventual risk prediction models. this will be a retrospective cohort study using longitudinal data from the population-based national health and aging trends study (nhats). this project will use novel methods to identify clinically meaningful subgroups of older adults based on long-term trajectories of bothersome pain and function. group-based trajectory modeling (gbtm) is a novel method to model dynamic phenomena such as pain and function. older adults at high risk of experiencing poor long-term pain and function outcomes will be identified by leveraging potential prognostic factors typically available in electronic health records or administrative data. it is anticipated that our results will provide new insights into long-term patterns of pain and function across the aging process and identify potential predictors of each trajectory.

Eligibility criteria:
inclusion criteria: * community-dwelling older adults from round 1 of the nhats cohort exclusion criteria: * participants who are non-ambulatory (require a wheelchair or scooter for mobility) at round 1

Keywords: older adults chronic pain function physical performance
analysis of cardiac damage post infection with sars-cov-2 and post vaccination against covid-19

Conditions: Myocarditis Acute

Summary: from may 2020 to may 2021, the investigators retrospectively evaluated clinical cardiac magnetic resonance (cmr) examinations performed in patients with suspected cardiac involvement post covid-19. between may 2021 and august 2021, the investigators evaluated patients with suspected cardiac disease after covid-19 vaccination.

hospital database for patients that underwent a clinical cmr examination between may 2020 and may 2021 for suspected cardiac pathology post covid-19 were analyzed. for comparison, cmr examinations from january until august 2021 were searched for suspected cardiac pathology post covid-19 vaccination. the study complies with the declaration of helsinki and was approved by the ethics committee of the charité-universitätsmedizin berlin (ea2/020/21). cmr imaging all scans were performed for clinical indications on either a philips ingenia 3.0 t scanner or a philips ambition 1.5 t scanner according to recent recommendations for cmr in patients post covid-19. protocols were adjusted to the clinical scenario but generally included standard cine imaging, t2 stir edema imaging, basal and medial short axis t2 mapping (t2-grase) and pre- and post-contrast t1 mapping (molli), and late-enhancement-imaging (mdixon). vasodilator stress with regadenosone or adenosine was performed in patients with clinically suspected myocardial ischemia. the adenosine dose was 0.140 µg/kg/min, with an increase to 0.210 µg/kg/min in case of insufficient response. the regadenosone dose was 200µg irrespective of weight, followed by theophyllin reversal as needed (max. 200mg). the contrast agent was 0.1 mmol/kg gadobutrol (gadovist®, bayer ag, leverkusen, germany). cmr image analysis image post-processing and measurements were performed according to recent recommendations using dedicated cmr post-processing software (intellispace portal v11.1, philips, best, the netherlands). the diagnosis of 'probable myocarditis' was based on the updated lake louise criteria requiring findings of myocardial damage (lge) and edema (t2 stir or t2 mapping) in a non-ischemic pattern (intramyocardial or subepicardial). evidence of edema without myocardial damage was considered 'possible myocarditis' whereas myocardial damage without edema was considered 'subsided myocarditis.

Eligibility criteria:
inclusion criteria: * cardiac mri for suspected cardiac involvement after covid-19 or covid-19-vaccination exclusion criteria: * none

Keywords: covid-19 covid-19-vaccine
project choice: efficacy testing of choice and choice+normative feedback interventions

Conditions: Substance-related Disorders

Summary: this study will use a pilot test format to examine the efficacy of a brief motivational interviewing (mi) intervention developed by the investigator dr. douglas smith called choice (compassionate helpers openly inviting client empowerment)with youth referred for substance abuse assessments to substance abuse treatment agencies in chicago and urbana, il.

this study will use a pilot test format to examine the efficacy of a brief motivational interviewing (mi) intervention developed by the investigator dr. douglas smith called choice (compassionate helpers openly inviting client empowerment)with youth referred for substance abuse assessments to substance abuse treatment agencies in chicago and urbana, il. the study will have two arms: one group will receive the standard choice motivational interview (mi) while the second group will receive the choice motivational interview with a normative feedback component, called choice+ (choice plus). the hypothesis is that there will be no difference in outcomes between those that receive the standard choice and those that receive the choice+ mi.

Eligibility criteria:
inclusion criteria: * youth 13-19 years of age (and their parents or legal guardians if their youth has been referred for an assessment with the prairie center counseling staff.) * referred for an assessment to see if they need substance use disorder treatment * have used substances on 13 or more days out of the past 90 days or scored higher than 2 on the craft assessment. - exclusion criteria: * low cognitive functioning

Keywords: motivational interview, normative feedback, adolescents
proton beam irradiation for the treatment of unresectable hepatocellular cancer or hepatic metastases

Conditions: Hepatocellular Cancer; Cholangiocarcinoma; Hepatic Metastases

Summary: the main purpose of this study is to determine if high doses of radiation using proton beam can be given safely with low and acceptable side effects. we will also gather information to determine the ability of proton beam to destroy cancer cells in the liver. there are two types of external radiation treatments (proton beam and photon beam). proton beam radiation is a very accurate kind of treatment that has been shown to affect less normal tissue than a regular radiation beam. the accuracy allows us to more safely increase the amount of radiation delivered to eliminate cancer and may potentially reduce the side effects normally experienced with standard radiation therapy.

* participants will receive treatment as an outpatient at the northeast proton treatment center located at the massachusetts general hospital. * since we are looking for the highest dose of proton beam radiation that can be given to people safely, not everyone who participates in this study will be receiving the same amount of radiation. small groups of people will be enrolled and given a certain dose of radiation. if they tolerate it well, the next small group of people enrolled will receive a higher dose. this will continue until we find the highest dose that can be given without causing serious or unmanageable side effects. * radiation treatment to the liver will be given once a day, 5 days a week (monday-friday), for 3 weeks. each treatment takes about 10-20 minutes. * a physical examination, medical history, and blood tests will be taken once a week for 3 weeks during radiation therapy. follow-up visits will occur every 3 months for 2 years, and every 6 months thereafter for 3 years, and then annually thereafter.

Eligibility criteria:
inclusion criteria: * biopsy proven unresectable or locally recurrent hepatocellular cancer, cholangiocarcinoma, or hepatic metastases. * primary lesion size of 6cm or less in greatest diameter * single or multinodular tumors (up to 3) * 18 years of age or older * no evidence of extrahepatic tumor * karnofsky performance status of 70-100 * if patient has underlying cirrhosis, only child's classification group a or group b * adequate renal function * expected survival of greater than three months exclusion criteria: * pregnant or lactating women * evidence of non-hepatic metastatic disease * local conditions or systemic illnesses which would reduce the local tolerance to radiation treatment, such as serious local injuries, active collagen vascular disease, etc. * prior radiation treatment to affected region * serious psychiatric illness which would limit compliance with treatment

Keywords: proton beam irradiation liver cancer
natural history of sickle cell disease

Conditions: Pain Crisis

Summary: this study is not a treatment protocol and no experimental treatments are involved. study participants may be seen as needed for clinical, translational and basic research studies, or as medically indicated. subjects will receive their general medical care outside the nih and will be seen at our clinic or at cnhs with varying frequency. subjects may be seen for multiple visits. subjects may be asked to return for additional testing as needed. clinical care for patients with sickle cell disease will be provided as appropriate through the sickle cell clinic and the inpatient clinical center.

this protocol will permit the establishment of a repository of biospecimens from individuals affected with sickle cell disease to identify and evaluate underlying disease mechanism(s), and to facilitate understanding of the pathogenesis and natural history of vaso-occlusive painful crisis and other complications of the disease. patients will be evaluated with a medical history and physical examination and routine laboratory studies will be obtained as needed to assess diagnosis, disease activity, and disease complications and to monitor for treatment-related responses and toxicities. this protocol may also provide for the continued storage and analysis of clinical and research data, and biospecimens previously obtained from other nih institutional review board (irb)-approved protocols with subject consent. patients eligible for other research protocols will be offered an opportunity to participate in these studies after signed informed consent has been obtained. apart from such protocols, any medical care or additional tests/investigations recommended or provided to the patient will be consistent with routine standards of practice and will be provided in consultation with the patient s referring physician.

Eligibility criteria:
* inclusion criteria: * individuals with known or suspected sickle cell disease * 2 years of age and older * willing to provide informed consent or appropriate informed consent from parent or legal guardian * patients seen at sickle outpatient clinics at any one of the participating centers (cnhs or nih). exclusion criteria: * patient and/or guardian unable and unwilling to give informed consent or assent. * patients less than 2 years of age.

Keywords: hemoglobin acute chest syndrome treatment options nitric oxide pulmonary hypertension natural history