Kornimate/medical-research-clean huggingface dataset:
mirror therapy education for acute stroke patients

Conditions: Stroke, Acute

Summary: in canada, the number of stroke survivors is equivalent to the size of one of the four atlantic provinces. the incident rate of stroke has been increasing steadily since 1995. the majority of the stroke survivors lose upper extremity function, resulting in diminished activities of daily living (adl). many therapeutic interventions are recommended to improve upper extremity function or adls of stroke survivors, however, mirror therapy (mt), inexpensive intervention, can be self-administered by stroke survivors with intact cognition. thus, the research question is whether a self-administered mt technique improves acute stroke patients' upper extremity motor function and recovery?


Eligibility criteria:
inclusion criteria: * admitted with diagnosis of stroke with onset within two weeks * medically stable * able to follow directions * no severe cognitive impairments that could interfere with patient participation * consent to treatment by patient * alpha-functional independence measure (alpha-fim) score of \> 40 exclusion criteria: * medical instability * lack of motivation * recurrent/ chronic stroke * recent upper extremity musculoskeletal injuries with movement restrictions * receptive or global aphasia * delirium * unilateral neglect * visual field deficiency.
neoadjuvant bevacizumab, capecitabine and radiation therapy with or without oxaliplatin locally advanced rectal cancer

Conditions: Locally Advanced Rectal Cancer

Summary: phase ii clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). academic, investigator initiated. to assess the activity of bevacizumab (avastintm) in combination with capecitabine (xelodatm) and radiation therapy with or without oxaliplatin (eloxatintm) in the pre-operative treatment of locally advanced rectal cancer, followed by tme (total mesorectal excision).

see synopsis

Eligibility criteria:
inclusion criteria: * adenocarcinoma of rectum measurable (recist), locally advanced (defined by mri - tumour beyond mesorectal fascia (t4) or tumour ≤ 2 mm from mesorectal fascia or t3 tumour \< 5 cm from anal verge * patient is at least 18 years of age * good organ function exclusion criteria: * evidence of distant metastases * contraindication for bevacizumab * pregnant or breastfeeding women.

Keywords: bevacizumab capecitabine radiation therapy oxaliplatin multimodality treatments tme (total mesorectal excision) axe beam rectal cancer neoadjuvant pathological complete response postoperative complications
expanded access protocol (eap) for nonconforming (nc) afami-cel

Conditions: Synovial Sarcoma; Myxoid Liposarcoma

Summary: the purpose of this expanded access protocol (eap) is to provide controlled access to afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (nc afami-cel). this eap will be conducted at authorized treatment centers where tecelra® is being administered and where the eap is approved to be conducted. patients who are prescribed tecelra® , sign the informed consent form, and meet all entry criteria will be eligible to participate in this protocol.


Eligibility criteria:
inclusion criteria: * patient must provide written informed consent prior to participating in this protocol * patient must have been prescribed tecelra® * patient's commercially manufactured product does not meet the commercial release specification * repeat manufacture is not feasible or is not clinically appropriate per investigator assessment in consultation with adaptimmune * repeat leukapheresis is not feasible or is not clinically appropriate per investigator assessment * the investigator has confirmed a favorable benefit:risk profile, following sponsor evaluation of the nc afami-cel, and deems proceeding with treatment under this eap is in the best interest of the patient * patient deemed medically fit and stable to receive nc afami-cel per investigator assessment * female patients with reproductive potential must have a negative serum or urine pregnancy test within 7 days of initiating lymphodepleting chemotherapy exclusion criteria: * patient has contraindication(s) as per the tecelra® uspi * do not use tecelra® in adults who are heterozygous or homozygous for hla-a\*02:05p
immune modulation therapy for pompe disease

Conditions: Pompe Disease

Summary: the purpose of this study is to assess anti-recombinant human acid α-glucosidase (anti-rhgaa) antibody titers after treatment with immune modulation therapy in patients of pompe disease.


Eligibility criteria:
inclusion criteria: * the patient (and/or patient's legal guardian if patient is \< 18years) must provide written informed consent prior to any study-related procedures that are performed; * the patient must have a confirmed diagnosis of pompe disease defined as a documented acid α-glucosidase (gaa) enzyme deficiency from blood samples or 2 gaa gene mutations; * the patient (and/or legal guardian) must have ability to comply with clinical protocol; * regimen a only: the patient is receiving enzyme replacement therapy, exhibits clinical decline, and has persistent high anti-recombinant human acid α-glucosidase (anti-rhgaa) antibody titers and/or tested positive for antibodies that inhibit enzymatic activity and/or uptake of myozyme; * regimen b only: the patient is cross-reactive immune material (crim) -negative and have not received myozyme infusion prior to enrollment exclusion criteria: * the patient is at risk of reactivation or is a carrier of hepatitis b or hepatitis c; * the patient is at risk of reactivation of tuberculosis or has regular contact with individuals who are being actively treated for tuberculosis; * the patient has used any investigational product (other than alglucosidase alfa) within 30 days prior to study enrollment; * the patient is pregnant or lactating; * the patient has had or is required to have any live vaccination within one month prior to enrollment.

Keywords: immune modulation therapy acid α-glucosidase antibody
prospective cohort of hiv/hbv-coinfected patients in europe

Conditions: HIV Infections; Hepatitis B; Coinfection

Summary: the overall aim of the project is to establish an international multi-cohort research platform of hiv/hbv-coinfected individuals treated with tenofovir to improve our understanding of the determinants of treatment outcomes.

hepatitis b virus (hbv) infection is a major cause of morbidity and mortality among human immunodeficiency virus (hiv)-infected individuals and the progression of liver disease is accelerated in this population compared to hbv-monoinfected individuals. tenofovir disoproxil fumarate (tdf) or tenofovir alafenamide (taf) as part of antiretroviral therapy (art) suppresses hbv viral load in most patients. however, risk factors of suboptimal virological response to tdf/taf and predictors of hepatitis b surface antigen (hbsag) loss remain unclear. while novel drugs for hbv therapy are being developed, a more thorough understanding of the factors associated with optimal outcomes is urgent. euro-b considers all hiv/hbv-coinfected participants from eurosida, the swiss hiv cohort study and french, spanish and german hiv-hbv cohorts treated with tdf/taf for inclusion. the overall aim of the project is to establish an international prospective multi-cohort research platform of hiv/hbv-coinfected individuals to improve our understanding of the determinants of treatment outcomes, including functional cure of hbv infection. specifically, we aim to: 1. evaluate hbv virological suppression, hepatitis b e antigen (hbeag) and hbsag loss as well as the course of quantitative hbsag (qhbsag) levels during tdf/taf-containing antiretroviral therapy 2. evaluate predictors of hbsag loss and its correlation with hepatitis b core-related antigen (hbcrag) and pre-genomic rna (pgrna) levels 3. explore risk factors for low-level hbv replication after 2 years of therapy 4. describe changes in liver fibrosis stage and rates of transaminase normalization over time and according to hbv therapy outcome 5. assess rates and reasons of treatment interruptions or changes.

Eligibility criteria:
inclusion criteria: * study participant from contributing cohort * 2 positive hbsag tests more than 6 months apart * at least 2 data points (baseline and 2 years after tdf/taf start either as available data or stored sample exclusion criteria: * none
trial to evaluate the efficacy of gsk biologicals' influenza vaccine gsk2186877a in adults 65 year of age and older

Conditions: Influenza

Summary: the purpose of this study is to evaluate the efficacy of glaxosmithkline biologicals' influenza vaccine gsk2186877a in adults 65 year of age and older. the study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.

this protocol posting has been updated according to protocol amendment 3, sep 2009. after the analyses for this study were completed, questions arose regarding the integrity of study data from a single study site in romania, which enrolled 102 subjects in the trial. because evaluation of data from this site did not reveal irregularities when compared with overall study data and because gsk has no current plans to use the data from the study in support of any regulatory filings, they were not excluded from the analyses reflected in this results summary.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol. * a man or woman aged 65 years or older at the time of the vaccination. * written informed consent obtained from the subject. * subjects with residence status allowing free mixing with general community. exclusion criteria: * bedridden subjects * previous vaccination against influenza since february 2008. * previous vaccination in the last three years with an investigational adjuvanted candidate seasonal or pandemic influenza vaccine. * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * any contra-indication to intramuscular administration of the influenza vaccines. * history of hypersensitivity to a previous dose of influenza vaccine. * history of allergy or reactions likely to be exacerbated by any component of the vaccine including egg and chicken protein. * acute disease at the time of enrolment. acute disease is defined as the presence of a moderate or severe illness with or without fever. all vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature \<37.5°c (99.5°f).

Keywords: efficacy influenza vaccines influenza vaccine elderly
comparison of 3 ultrasonic techniques for measuring the systolic pressure index

Conditions: Peripheral Arterial Disease; Atherosclerosis Obliterans; Atherosclerosis Right Leg; Atherosclerosis Left Leg

Summary: continuous doppler ankle brachial index (abi) is the gold standard for screening and monitoring of peripheral arterial disease (pad) but is no longer carried out in clinical practice. the recommended measurement was gradually replaced by colour or pulsed doppler without validation of these techniques. the objective of our study is to compare these two techniques (color doppler and pulsed doppler in echodoppler) with respect to the gold standard (continuous doppler) for abi measurement.


Eligibility criteria:
inclusion criteria: patient referred to the vascular medicine department of caen university hospital for a vascular examination with abi measurement having been informed and not objecting to participation in the study and benefiting from a social protection system. exclusion criteria: * patient with arrhythmia * patient with trans-tibial or more proximal amputation * patient with extensive trophic disorder not allowing measurement * patient with subgonal bypass * known bilateral sub-clavian stenoses * patient deprived of liberty or under a measure of legal protection * interned patient for the treatment of a psychiatric or physical illness * patients who are legally incompetent, under the protection of justice, under guardianship or trusteeship.

Keywords: ankle brachial index color duplex ultrasound pulsed doppler
clinical study of behavior problems in children after different anesthesia methods

Conditions: Child Behavior; Problem Behavior

Summary: the aim of this study is to investigate long-lasting or later behavioral changes in children in the context of different anesthesia techniques (inhalation anesthesia vs. tiva)

the process of surgery and anaesthesia can be an extremely frightening and stressful event for a child, and is frequently followed by negative postoperative behavioural changes. this event could be associated with poor postoperative outcome and long term behavior problems like anxiety, eating or sleeping disorders. the aim of this study is to investigate long-lasting or later behavioral changes in children in the context of different anesthesia techniques (inhalation anesthesia vs. tiva). after anesthesia initiation, anesthesia maintenance should be done with sevoflurane or tiva. the effect of behavioral changes in children in the context of anesthesia techniques should be evaluate by post hospitalisation behavior and strengths and difficulties questionnaire at first, second and fourth week. early postoperative problems like postoperative nausea and vomiting, pain level, pain therapy and postoperative awareness should be evaluate too.

Eligibility criteria:
inclusion criteria: * elective operation * operation in general anesthesia in combination with regional anesthesia * age 2-10 years * asa classification 1 or 2 (without severe basic disease or disability) exclusion criteria: * lack of consensus * general anesthesia during the last 3 months before or 4 weeks after the procedure * ponv prophylaxis with droperidol * severe known growth factor * mental pre-existing conditions and behavioral abnormalities * contraindications for one of the used study medications * insufficient regional anesthesia * secondary intervention within of the 4-week follow-up

Keywords: child behavior problem behavior postoperative behaviour problems
lung injury prediction study

Conditions: Respiratory Distress; Acute Lung Injury

Summary: the purpose of the study is to externally validate the acute lung injury/acute respiratory distress syndrome (ali/ards) prediction model (lung injury prediction score - lips) in a multicenter sample of patients at risk presented to the acute care hospitals: united states critical illness and injury trials group (usciitg).


Eligibility criteria:
inclusion criteria: * hospitalized adult patients with one of the known risk factors for acute lung injury at the time of hospital admission exclusion criteria: * ali/ards already present at the time of hospital admission, denied use of medical records for research, children, hospital readmission, transfer from another hospital

Keywords: respiratory distress, adult risk emergency room high risk surgery sepsis trauma aspiration pneumonia
dose-finding study of four dosage levels of an h7n9 influenza vaccine in adults between ages of 18 years and 65 years

Conditions: H7N9 Influenza

Summary: evaluate the safety and immunogenicity of four different doses of h7n9 vaccination in adults between the ages of 18 years and 65 years.


Eligibility criteria:
inclusion criteria: 1. healthy adult subject ages 18-64 years. 2. individuals willing to provide written informed consent 3. individuals in good health. 4. individuals who can comply with study procedures and follow-up. exclusion criteria: 1. individuals with history of cognitive or behavioral impairment or psychiatric disease, 2. individuals unable to understand and follow study procedures, 3. history of significant illness, 4. history of chronic medical condition or progressive disease, 5. allergy to any vaccine component or adverse event related to a vaccine component, 6. impairment/alteration of the immune system, 7. presence of progressive or severe neurological disorder, 8. pregnant or breast-feeding, 9. female of child-bearing potential unwilling to use acceptable method of birth control, 10. presence of medically significant cancer, 11. receipt of investigational product within 30 day prior to entry into the study, 12. history of previous or suspected illness from avian flu caused by h7n9 virus, 13. history of h7 vaccination, 14. body temperature of greater than or equal to 38.0°c (100.4◦f) and/or acute illness within 3 days of intended study vaccination, 15. receipt of any flu vaccination 2 weeks before study entry or 4 weeks after study vaccination, 16. receipt of any vaccination 2 weeks before study entry or 4 weeks after study vaccination, 17. history of drug or alcohol abuse within the past 2 years, 18. body mass index (bmi) greater than or equal to 35kg/m2, 19. individuals conducting the study or their immediate family members.

Keywords: influenza, h7n9, vaccine
study to evaluate adverse events and change in disease activity when intravenous (iv) infusion of abbv-927 is administered in combination with iv modified folfirinox (mffx) with or without iv budigalimab compared to mffx in adult participants with untreated pancreatic cancer metastasis

Conditions: Pancreatic Cancer

Summary: metastatic pancreatic cancer disease is one of the most aggressive and deadliest forms of cancer with very poor survival. this study will evaluate adverse events and change in disease activity in participants 18 to 75 years of age with a body weight greater than or equal to 35 kg with metastatic pancreatic cancer disease treated with intravenous (iv) infusion of modified folfirinox (mffx) combined with iv infusions of abbv-927 with or without budigalimab. abbv-927 and budigalimab are the investigational drugs being developed for treatment of metastatic pancreatic cancer disease. in this study, doctors will enroll participants between 18 and 75 years of age with a body weight greater than or equal to 35 kg diagnosed diagnosed with metastatic pancreatic cancer disease in 4 different groups, called treatment arms. each group will receive different treatments. approximately 129 adult participants will be enrolled in the study across approximately 27 sites worldwide. participants will receive abbv-927 and budigalimab as intravenous (iv) infusion in phase 1b on day 3 of every 28 day cycle, modified folfirinox as iv infusion in phase 1b on day1 and day 15 of every 28 day cycle up to maximum of 2 years. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

study study was terminated before the phase 2 portion of the study began.

Eligibility criteria:
inclusion criteria: * body weight \>= 35 kg. * histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease. * measurable disease per response evaluation criteria for solid tumors version 1.1 (recist v1.1). * prior history of or clinically stable concurrent malignancy are eligible for enrollment provided the malignancy is clinically insignificant, no treatment is required, and the participant is clinically stable. exclusion criteria: * participants with locally advanced disease. * participants with neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma. * prior radiotherapy, surgery, or systemic anti-cancer therapy for the treatment of metastatic pancreatic adenocarcinoma. * prior radiotherapy, surgery, or systemic anti-cancer therapy in the adjuvant setting, or earlier, within the last 4 months. * prior radiotherapy to any measurable metastatic lesion at any time. * clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion). * known metastases to the central nervous system (cns).

Keywords: metastatic pancreatic cancer disease abbv-927 modified folfirinox (mffx) budigalimab abbv-181 cancer
investigation of plasma proteins in patients with hereditary haemorrhagic telangiectasia and pavms

Conditions: Telangiectasia, Hereditary Hemorrhagic

Summary: hereditary haemorrhagic telangiectasia (hht, also known as osler-weber-rendu syndrome) is an disease that leads to the development of dilated and fragile blood vessels, including arteriovenous malformations in the lungs (pavms). we hypothesize that the genetically-determined abnormality in the blood vessels of hht patients leads to alteration in the concentrations or activity of several proteins in the blood stream. we propose to take blood samples from patients at defined times in order to study changes in blood protein levels and activity


Eligibility criteria:
inclusion criteria:patients with hereditary haemorrhagic telangiectasia and pulmonary arteriovenous malformations - exclusion criteria:unable to provide informed consent -

Keywords: hereditary hemorrhagic
retrospective analysis of real world use of ceftazidime-avibactam in the management of gram negative infections

Conditions: Gram Negative Infections

Summary: the main objective of this non-interventional (retrospective) study is to describe the general treatment patterns, effectiveness, and safety of ceftazidime-avibactam in real-world settings in india. eligible patients would be adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice from 01 june 2019 to 01 april 2020. data of 500 patients will be collected through the abstraction of hospital medical records (electronic) if available or through the individual patient medical record in case electronic records are not available.


Eligibility criteria:
inclusion criteria: 1. more than or equal to 18 years of age 2. admitted to hospital with documented gram negative infection 3. has received treatment for atleast 48 hours (complete) with ceftazidime-avibactam as a part of his routine clinical management exclusion criteria: 1. the patient is enrolled in any clinical trial of an investigational product 2. age \<18 years 3. received ceftazidime avibactam for less than 48 hours. 4. patient with documented acinetobacter infection. 5. patient was a part of named access program or any other interventional study