Kornimate/medical-research-clean huggingface dataset:
trastuzumab emtansine(t-dm1) after trastuzumab deruxtecan(t-dxd) in her2-positive breast cancer in korea

Conditions: Cancer of Breast; Trastuzumab Emtansine; Trastuzumab Deruxtecan

Summary: prospective observational study of trastuzumab emtansine immediately after trastuzumab deruxtecan in patients with advanced her2-positive breast cancer in korea


Eligibility criteria:
inclusion criteria: * her2-positive, advanced (unresectable locally advanced or metastatic) breast cancer * prior treatment with trastuzumab deruxtecan(t-dxd) in the advanced setting * intention to treat with trastuzumab emtansine (t-dm1) as first therapy upon t-dxd progression exclusion criteria: * any systemic treatment, other than t-dm1, for breast cancer after trastuzumab deruxtecan (as an exception, patients treated with endocrine agents, not in combination with cytotoxics or antibody-drug conjugates, will be permitted in the study) * has been previously treated with t-dm1 for advanced breast cancer * has been previously treated with 4 or more lines of therapy for advanced breast cancer * half (50%) or more patients will be those who were treated with second-line trastuzumab deruxtecan (i.e. patients at the later line will be capped).
exercises associated or not with manual therapy shoulder impingement

Conditions: Shoulder Impingement

Summary: manual therapy combined with a protocol of therapeutic exercises will increase the beneficial effects on scapular kinematics, myofascial pain and function in subjects with shoulder impingement when compared to exercises only.


Eligibility criteria:
inclusion criteria: * history of non-traumatic onset of shoulder pain; * painful arc during active elevation of the arm; * one or more positive shoulder impingement tests (neer, hawkins and jobe), or pain during passive or resisted external rotation of the arm at 90° of abduction; * pain with palpation of the rotator cuff tendons; * all subjects need also to be able to reach 150° of arm elevation as evaluated by visual observation. exclusion criteria: * limitation of glenohumeral internal and external rotation as indicative of adhesive capsulitis; * body mass index \> 28kg/m2 as the amount of subcutaneous tissue can compromise the quality of the signal increasing soft tissue artifact; * numbness or tingling of the upper limb reproduced by cervical compression test; * history of clavicle, scapula or humerus fracture; * history of rotator cuff surgery; * systemic illnesses; * positive sulcus or apprehension tests as indicative of instability; * positive drop arm test as indicative of full thickness tear; * corticosteroid injection within 3 months prior to intervention, or physiotherapy within 6 months prior to intervention; * depressive symptoms as evaluated by the beck depression inventory score ( \> 9 points) due to its influence on myofascial pain; * allergy to tape.
direct peritoneal resuscitation plus conventional resuscitation

Conditions: Hepatic Cancer

Summary: the purpose of this study is to find out if direct peritoneal resuscitation (dpr) (putting a sugar solution into the abdominal cavity) helps blood flow through vital organs in the body that may suffer from low blood flow due to surgery. we will also try to find out if the dpr will help patients recover faster from liver surgery. lastly, this study will also try to find if direct peritoneal resuscitation decreases levels of signaling chemicals in the blood called 'cytokines' and a protein called high-mobility group protein 1, which is known to cause tissue damage.

our study will focus on 108 patients requiring hepatic resection for colorectal cancer metastasis or primary hepatocellular carcinoma. these patients will then be randomized into two 54 patient arms: the control arm of conventional resuscitation only and the experimental arm of conventional resuscitation with dpr immediately post operatively. patient exclusion criteria will be: 1) unable to obtain proper consent for enrollment, 2) age less than 18 years or greater than 75 years, 3) chronic renal failure, cirrhosis, or congestive heart failure, 4) patients requiring portal venous embolization prior to resection, or 5) women who are pregnant or lactating/breast feeding. a pregnancy test (urine or blood) will be done for female subjects of child bearing potential the day prior or the morning of surgery per the usual standard of care pre-op labs.

Eligibility criteria:
inclusion criteria: * colorectal cancer * scheduled for liver resection * 18 to 75 exclusion criteria: * chronic renal failure * cirrhosis * congestive heart failure * requiring portal venous embolization prior to resection * pregnant or nursing

Keywords: liver cancer
incorporating telecbit into a hospital-based tic program

Conditions: Tic Disorders; Tourette Syndrome

Summary: this is a single-arm open trial of comprehensive behavioral intervention for tics (cbit) delivered to pediatric and adult patients with persistent tic disorders in their homes via videoconferencing (i.e., telecbit). all participants who enroll will receive telecbit.

comprehensive behavioral intervention for tics (cbit) is a behavioral therapy with proven efficacy for treating persistent tic disorders (e.g., tourette syndrome) in youth and adults. lack of access to a local cbit provider prevents treatment access for many patients who could benefit from cbit. providing cbit to patients in their homes via videoconferencing technology (i.e., telecbit) is a promising approach to increasing cbit access. this study investigates treatment uptake, acceptability, feasibility, and clinical effectiveness of telecbit among pediatric and adult patients enrolled as patients in a state-of-the-art medical tic program.

Eligibility criteria:
inclusion criteria: * age 5-65, diagnosis of tourette syndrome or other persistent tic disorder (per diagnostic interview and self-report of prior physician diagnosis) * clinical global impressions - severity score \> 3 (i.e., "moderately ill" or worse), * unmedicated or on stable medication treatment for tics and psychiatric problems, * fluency in english * a functional accessible home computer and high speed (i.e., cable/dsl) internet connection * willingness to sign a release of information to contact a local, licensed medical or mental health provider, of whom they are currently a patient (in case of emergent safety concerns). * minor participants must have a parent or guardian who is fluent in english available to attend treatment and assessment sessions. exclusion criteria: * significant suicidality, (i.e., a score of \> 12 on the mini or mini-kid suicidality module); * prior diagnoses of intellectual disability; pervasive developmental disorder, mania, schizophrenia, psychotic disorder, substance abuse, substance dependence, or conduct disorder; currently experiencing a psychosocial, psychiatric, or neurological problem that requires immediate care * lack of a functional home computer with high speed (i.e., cable or dsl) internet connection; * or, prior receipt of \>3 previous sessions of behavior therapy for tics within the past year (per self/parent report)
mass drug administration of ivermectin and dihydroartemisinin-piperaquine as an additional intervention for malaria elimination

Conditions: Malaria

Summary: this is a community-based cluster-randomized trial in which a novel approach to interrupt residual malaria transmission by mass drug administration (mda) with ivermectin (ivm) combined with dihydroartemisinin-piperaquine (dp) will be tested. this cluster-randomized trial will involve 32 villages in the upper river region of the gambia that will be randomized to mda with ivm and dp or to standard of care in a ratio 1:1. this trial aims at establishing whether mda with ivm and dp can reduce or interrupt malaria transmission in medium to low transmission settings by reducing vector survival and the human reservoir of infection. mda with ivm and dp will be implemented in the intervention villages and all human settlements in the buffer zone, with the aim of minimizing spillover effects. control clusters will receive standard malaria control interventions as implemented by the national malaria control program. the primary outcomes will be the prevalence of malaria infection determined by molecular methods in all age groups at the peak of the second transmission season (november-december 2019) and the vector's parous rate 7-14 days after mda.

the hypothesis of this project is that mass drug administration (mda) with ivermectin (ivm) and dihydroartemisinin-piperaquine (dp) can reduce or interrupt malaria transmission in medium to low transmission settings by reducing vector survival and the human reservoir of infection. the research questions include the following: 1. will mda with ivm plus dp (3 rounds per transmission season) in communities with high coverage of vector control interventions further reduce malaria transmission (up to local elimination)? 2. will mda with ivm suppress the vector population? 3. what is the most socially acceptable and sustainable way of achieving and maintaining high coverage of mda with ivm and dp, and of embedding it within local communities and stakeholders? 4. what is the impact of mda with ivm on prevalence of ectoparasites and helminths 5. what is the cost and cost-effectiveness of this intervention compared to standard malaria control measures?

Eligibility criteria:
inclusion criteria * age/anthropometry 1. for ivm: weight ≥ 15kg or height ≥90 cm; 2. for dp: age \> 6 months * willingness to comply with trial procedures * individual written informed consent obtained at the beginning of the study exclusion criteria: * exclusion criteria for both ivm and dp will include the following: * known chronic illness (eg hiv, tb, hepatitis and severe malnutrition). additionally for ivm: 1. pregnancy (any trimester) and breast feeding 2. hypersensitivity to ivm 3. travel to loa loa endemic countries (e.g. central africa) additionally for dp: 1. first trimester pregnancy 2. hypersensitivity to dp 3. taking drugs that influence cardiac function or prolong qtc interval

Keywords: transmission reduction
study on osseospeed™ implants replacing 2-5 teeth in the posterior upper jaw, restored with provisional teeth attached 6-7 weeks later

Conditions: Jaw, Edentulous, Partially

Summary: the purpose of the study is to evaluate astra tech dental implant system, fixture osseospeed™, in patients with tooth loss in the posterior maxilla in an early loading protocol. primary objectives are implant stability, marginal bone adaptation and survival rate.


Eligibility criteria:
inclusion criteria: * provision of written informed consent * 18 years of age and over * edentulous in the posterior maxilla, kennedy classes i or ii. last natural tooth, or previously restored implant in function is canine or first bicuspid. * deemed by the investigator as likely to present an initially stabile implant situation suitable for early loading exclusion criteria: * untreated caries and/or periodontal disease of residual dentition * history of edentulism in the area of implant placement of less than two months * current need for pre-surgical bone or soft tissue augmentation in the planned implant area. * history of pre-surgical bone or soft tissue augmentation, within12 months, in the planned implant area. * sinus floor thickness of less than 5 mm, verified by periapical radiographs. * any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration * need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration * present alcohol or drug abuse * unable or unwilling to return for follow-up visits for a period of 5 years * current use of smoking tobacco * pregnancy or lactation at the time of enrollment

Keywords: jaw, edentulous, partially (posterior maxilla)
quantitative neuromuscular ultrasonography in amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: amyotrophic lateral sclerosis (als) is a progressive and fatal neurological disease. nonspecific symptoms lead to a delay in the diagnosis, only confirmed by the electrophysiologic study. objectives. 1. to establish the diagnostic value of ultrasonography in als. 2. to evaluate the rate of muscle and nerve degeneration by ultrasonography in patients with als. 3. to check the relationship between ultrasound, clinical variables and functional tests in patients with als. methods. a longitudinal observational study in a consecutive sample of patients diagnosed with als will be realized. all the patients will be examined 3 times during 6 months and capabilities associated with als and muscle strength will be assessed. bilateral and cross sectional ultrasonography of several muscles and also median and tibial nerves will be performed. all the images will be processed and analyzed for obtaining morphometric variables (muscle thickness and nerve area) and textural ones (echogenic variation, entropy, homogeneity, textural contrast and correlation). frequency of twitches will be also recorded. after longitudinal study, a survival study will be performed in relation to functional and sonographic variables.


Eligibility criteria:
inclusion criteria: * definite als. exclusion criteria: * primary lateral sclerosis (pls) * other forms of motor neuron disorders.

Keywords: amyotrophic lateral sclerosis ultrasonography motor neurons neuromuscular diseases fasciculation
autologous bone marrow cell transplantation in persons with acute spinal cord injury- an indian pilot study.

Conditions: Acute Spinal Cord Injury

Summary: pilot study on 7 subjects in each group (total 21 subjects) to establish the safety and feasibility of autologous bone marrow cell transplantation in case of acute complete spinal cord injury by each of the following techniques and a corresponding number of controlled subjects: * directly into the injured site with a syringe after exposing the spinal cord. * by intrathecal injection.

intervention : autologous bone marrow cell: transplantation of the autologous bone marrow cell transplantation through one of the below mentioned techniques: 1. directly into the injured spinal cord site with a syringe after exposing the spinal cord. 2. by intrathecal injection. number of cells injected: 200 million cells in 1.8 ml of autologous plasma. in case of direct delivery, the cells were delivered in one sitting at six sites ( 2 above the lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. in case of intrathecal injection, the cells were delivered as a single injection of 1.8ml via lumbar puncture. frequency of injection: single total duration of therapy: the procedure of bone marrow harvesting, enrichment and transplantation was completed in a single setting of approximately 2-3 hours. the transplantation procedure in case of direct delivery took 2 mins per injection site that is approximately 12 mins and in case of lumbar puncture the transplantation procedure took approximately 2 mins. comparator agent:control: control subjects with acute complete spinal cord injury who would not receive any bone marrow transplantation.

Eligibility criteria:
inclusion criteria: 1. acute spinal cord injury between 10 days and 14 days post injury. 2. the subject must have a traumatic spinal cord injury between the spinal segmental levels t1 and t12 (neurological level). 3. must have a complete injury (asia-a). exclusion criteria: 1. subject whose medical condition requires mechanical ventilation. 2. subjects with neurological level of injury above t1 and below t12. 3. subjects more than 14 days and less than 10 days post-injury. 4. lower motor neuron injury. 5. subjects with pathological fracture. 6. spinal injuries in subjects with ankylosing spondylitis. 7. subjects with extremes of age: less than 18 years or more than 50 years. 8. subjects with pre-existing severe medical disease which would affect the outcome like severe diabetes, rheumatoid arthritis. 9. subjects with psychological disorders. 10. female subjects with pregnancy.
treatment patterns and outcomes in patients treated with benefix or refacto/refacto af - a swedish cohort study

Conditions: Hemophilia A; Hemophilia B

Summary: the overall aim of the study is to describe demographic and clinical characteristics, treatment patterns and outcomes, in the populations of hemophilia patients treated with benefix and refacto/refacto af in sweden

the overall aim of the study is to describe demographic and clinical characteristics, treatment patterns and outcomes, as well as the related direct treatment costs in the populations of hemophilia patients treated with benefix and refacto/refacto af, and in subgroups (e.g. level of severity) at the mhc in sweden. the study population will consist of all patients diagnosed with haemophilia (d66.9 (haemophilia a) d67.9 (haemophilia b) in international statistical classification of diseases and related health problems (icd-10) that have been registered in the mhr since 1977 and that have had at least one registered prescription of benefix or refacto/refacto af in the mhr since market authorization of the respective product (benefix august 27 1997, refacto april 13 1999, refacto af july 1 2009). diseased individuals are included. information on drugs picked up at the pharmacy is available in the prescribed drug register from 2005.

Eligibility criteria:
inclusion criteria: * the study population will consist of all patients diagnosed with hemophilia (d66.9 (hemophilia a) d67.9 (hemophilia b) in international statistical classification of diseases and related health problems (icd-10) that have been registered in the malmö hemophilia register since 1977 and that have had at least one registered prescription of benefix or refacto/refacto af in the mhr since market authorization of the respective product exclusion criteria: * no exclusion criteria in this study
effects of same in patients with alcoholic liver disease

Conditions: Liver Disease, Alcoholic

Summary: prior studies in animal models have established that the pathogenesis of alcoholic liver disease (ald) is regulated in part by the effects of chronic alcohol abuse on hepatic methionine metabolism. the hypothesis of the clinical study was that provision of the methionine metabolite s-adenosylmethionine (sam) would correct abnormal hepatic methionine metabolism thereby effectively treating ald. the two goals of the clinical research were a)to determine the clinical relationship of aberrant hepatic methionine metabolism to ald by comparisons of patterns of serum methionine metabolites in groups of ald patients, alcoholics without liver disease, and normal healthy subjects, and b) to determine the treatment effects of sam on patterns of serum methionine metabolites and on the histopathology and biochemical features of liver injury in ald patients.

we assessed a total of 297 potential ald candidates, from whom 40 were enrolled in the study. in addition, we enrolled 26 gender matched active alcohol drinkers without liver disease (ad) and 28 age and gender matched healthy control subjects (hs). of the original 40 ald subjects who provided initial enrollment data, 3 declined to proceed with the trial. therefore, 37 ald patients were randomized to receive sam at a dose of 400 mg or placebo three times daily for 24 weeks. however 11 of these dropped out after initial evaluation, leaving 26 ald patients, 13 in each arm, who completed the 24 week trial.

Eligibility criteria:
inclusion criteria * ald) a history of chronic alcoholism according to established audit and who criteria with the presence of clinical and laboratory features of established liver disease. also, willingness to undergo liver biopsies at start and completion of the study, and to comply with study medication or placebo and required clinic visits and blood sampling. * a history of chronic alcoholism without evidence of liver disease; * healthy subjects without history of alcoholism or presence of liver disease. exclusion criteria: * viral hepatitis b or c * hemochromatosis * wilson disease * sclerosing cholangitis * primary biliary cirrhosis * other chronic disease * renal insufficiency

Keywords: alcoholic liver disease (ald) s-adenosylmethionine same
effects of prolonged dapt after lower extremity percutaneous transluminal angioplasty (pta) in patients with le-pad

Conditions: Peripheral Artery Disease

Summary: the objective of the present study was to evaluate the prognostic impact of prolonged dual antiplatelet therapy (dapt) with acetylsalicylic acid plus clopidogrel on the incidence of major adverse cardiovascular events and major adverse limb events after percutaneous lower extremity revascularization in patients with lower extremity peripheral arterial disease (le-pad).


Eligibility criteria:
inclusion criteria: * le-pad at stage 2 of fontaine's classification (intermittent claudication) * successful pta of aorto-iliac, femoro-popliteal ore below-the-knee segments exclusion criteria: * critical limb ischemia * recent acute coronary syndrome (\< 12 months) * recent cerebrovascular event (\< 12 months) * recent myocardial, carotid or peripheral revascularization (\< 12 months) * recent history of bleeding (\< 12 months) * other indication for clopidogrel therapy * indication for anticoagulation * de-compensated heart failure * malignant neoplasm

Keywords: dual antiplatelet therapy peripheral transluminal angioplasty
activated recombinant human factor vii in patients with dengue haemorrhagic fever

Conditions: Acquired Bleeding Disorder; Dengue Haemorrhagic Fever

Summary: this trial is conducted in asia. the aim of this is to investigate the efficacy and safety of activated recombinant human factor vii (rfviia) in achieving haemostasis in patients with dengue haemorrhagic fever (dhf).


Eligibility criteria:
inclusion criteria: * patients with the clinical diagnosis of dengue haemorrhagic fever (dhf) * patients with a clinical diagnosis of dhf grades ii and iii8, requiring standard replacement therapy exclusion criteria: * patients with a clinical diagnosis of dhf grade iv * known or suspected allergy to trial product or related products * known hypersensitivity to mouse, hamster or bovine protein * prior treatment with activated recombinant human factor vii