Kornimate/medical-research-clean huggingface dataset:
the effect of semantic support on word learning

Conditions: Language Development Disorders

Summary: the goal of this clinical trial is to compare word learning outcomes in late talking toddlers who are taught different types of words. the main question it aims to answer is if teaching words that come from categories that children already know (e.g., animals) will aid overall word learning. children will take part in the vocabulary acquisition and usage for late talkers (vault) word learning treatment and be taught words from more familiar or less familiar categories to see which group learns more words overall.

children will be assigned to either the familiar or less-familiar word group. all children will receive 8 weeks of vocabulary acquisition and usage for late talkers (vault) word learning treatment (2x/wk for 30 minutes each session). the investigators will measure how well children learn the words they are taught as well as the words that are in the environment, but not explicitly taught (control words). this will help us know if their learning is due to treatment or maturation. the investigators will compare children to themselves (taught words v. control words) to ensure that the overall treatment is working. then, the investigators will compare children in the familiar word group to children in the less-familiar word group to see which group learns more overall.

Eligibility criteria:
inclusion criteria: * native english speaking * pass pure tone hearing screening or medical report of normal hearing * 2-3 years of age * mcdi expressive scale \<10th percentile exclusion criteria: * parental report of other diagnoses * enrolled in concurrent treatment elsewhere * nonverbal iq \<75 as measured by the bayley scales * parents unable to consistently bring child to treatment sessions

Keywords: late talkers
foot reflexology in ocular hypertensive and glaucoma patients

Conditions: Ocular Hypertension; Glaucoma

Summary: to determine the effect of foot reflexology in primary open angle glaucoma (poag) patients and the effect of a shoe insert to perform continuous foot reflexology in ocular hypertensive (ohtn) patients.

this is a prospective pilot study in glaucoma patients and a prospective therapeutic trial in ocular hypertensive patients. patients were recruited from the temple ophthalmology outpatient clinic. primary open-angle glaucoma patients were recruited from those about to have slt for additional intraocular pressure (iop) lowering. ohtn patients were recruited from the clinic. the glaucoma patients performed a 5-minute foot massage on a foot massage board and the iop was checked pre-massage, post-massage and 30, 60, 90 and 120 min post massage. ohtn patients underwent a one-month drop washout and then performed a 5-minute massage using a 3d-printed shoe insert with the identical pressure checks. they then were randomly assigned to wear the shoe insert or a sham insert for one day. iop was checked before inserting the insert and at the end of the day. the number of steps was recorded each day.

Eligibility criteria:
the inclusion criteria for this study in each study group are as follows. * patients with ocular hypertension (age 30-90) who may or may not have been included in the original pilot study. * patients with poag (age 30-90) who are being asked to increase therapy to further lower their iop. the exclusion criteria for both study groups will be: * current participation in fr or other complementary and alternative medicine techniques who will not participate in a washout period. * ocular hypotensive drop treatments for ocular-hypertension who will not participate in a washout period. * previous eye surgery or laser treatment. * physical inability to perform the tasks. additional exclusion criteria for the foot insert only will be: * diabetes * parkinson's disease * neuropathy * gait abnormalities
phase 2 trial of enzastaurin in prostate cancer in participants who have had hormonal and chemotherapy

Conditions: Prostate Cancer

Summary: the purpose is to see how quickly two different types of prostate cancer participants respond when taking enzastaurin. cohort 1 - asymptomatic participants with androgen-independent prostate-specific antigen (psa)-progressive disease without clinical or radiographic evidence of metastatic disease. cohort 2 - participants with androgen-independent metastatic prostate cancer (documented bone or soft tissue metastases) with rising psa, clinical, radiographic disease progression following one prior docetaxel-based regimen


Eligibility criteria:
inclusion criteria: * you are expected to be alive in the 12 weeks. * you are at least 18 years old. * you live close enough to the doctor's office to attend all of your required visits. * you have not been treated with chemotherapy for your prostate cancer (cohort 1). * must have evidence of androgen-independent psa-progressive disease without a history of or current (as judged by the investigator) clinical or radiographic evidence of metastatic disease with castrate levels of testosterone (\<50 ng/dl) maintained by luteinizing hormone-releasing hormone (lhrh) agonist or bilateral orchiectomy following standard anti-androgen withdrawal. note: psa progression is defined as have rising psa values of \<=5 ng/ml (at least 3 measurements 1 week apart) with castrate levels of testosterone \<50 ng/dl following appropriate antiandrogen withdrawal, without evidence of metastases. (cohort 1) * no prior systemic chemotherapy for prostate cancer. no prior chemotherapy for any other indication within 2 years of study entry. note: participants previously treated with chemotherapy in the adjuvant/neoadjuvant setting were not be eligible. (cohort 1) * you have had one prior docetaxel-based chemotherapy regimen (cohort 2). * you have evidence of metastatic prostate cancer with bone or soft tissue disease (cohort 2). * must have evidence of docetaxel-resistant, androgen-independent metastatic prostate cancer with bone or soft tissue disease (psa only participants are not eligible) defined as either: clinical, psa or radiographic disease progression while receiving docetaxel-based therapy or psa and/or radiographic progression at any time after completion of a docetaxel-containing regimen with psa progression defined as a 25% increase in psa from the post docetaxel value or interval progression in known metastatic sites of disease or development of new sites of disease on bone scan or computed tomography (ct) imaging. note: participants who discontinued a docetaxel-containing regimen due to toxicity or any other reasons not related to disease progression while on treatment, and were not able to complete at least 2 cycles, were not be eligible. (cohort 2) * your organs must be functioning properly. exclusion criteria: * you are unable to swallow pills. * you have another illness besides your prostate cancer. * you have taken another experimental drug within the last 30 days. * you have a serious heart condition. * you are receiving another anti-cancer therapy.
thoracic spine manipulation on pressure pain sensitivity of active myofascial trigger points in rhomboid muscle

Conditions: Trigger Points

Summary: this study intends to determine the effects of thoracic manipulation on pressure pain sensitivity in patients with rhomboid active trigger points.

this is a single blinded controlled trial and will be conducted at physiotherapy clinic of women institute of rehabilitation sciences abbottabad. the "screw" manipulation is a fairly aggressive manipulative technique in which the transverse processes are forced into a posterior to anterior direction individual will be screened out according to inclusion criteria. individuals will be allocated randomly into two groups, 30 in thoracic manipulation group and 30 in conventional physiotherapy protocol group by sealed envelope method. both groups will receive conventional physiotherapy protocol (manual pressure release technique and muscle imbalances exercises) for rhomboid trigger points in common and the experimental group will receive thoracic manipulation in addition to conventional protocol. assessment will be done on baseline and after 3 weeks. data will be analyzed on spss version 21.

Eligibility criteria:
inclusion criteria: * age between 18 to 30 years * participants presented with interscapular pain * forward head posture with active trigger points in rhomboid muscle * segmental hypomobility in upper thoracic identified with positive springing test exclusion criteria: * participants who demonstrated contraindication to manipulation * open wounds or trauma to the area which occurred less than two months prior treatment * any neurological compromise * mid scapular pain due to degenerative process or osteoporosis

Keywords: trigger area
dutch sub study: controlled rosuvastatin multinational study in heart failure (corona). pet sub study

Conditions: Rosuvastatin; Heart Failure; Positron Emission Tomography (PET)

Summary: at one site, patients participating in the corona main study are asked to participate in the pet-substudy. before and 6 months after study medication is started a positron emission tomography (pet-scan) is performed to study the effect of rosuvastatin in chronic heart failure on myocardial perfusion (reserve)


Eligibility criteria:
inclusion criteria: * patients fulfilling the in and exclusion criteria of the corona study and separate informed consent for participation in the sub study. exclusion criteria: * see above
phase 1 study of vegf trap in patients with diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: to assess the ocular and systemic safety and tolerability of a single intravitreal injection of vegf trap in patients with diabetic macular edema.

this is an open label study. initially, 5 patients with dme will receive an itv injection of vegf trap into the study eye. additional patients may be enrolled at the same or additional dose levels. patients will be observed for six weeks following the injection for assessments of ocular and systemic safety.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes mellitus (type 1 or type 2). * best corrected e-etdrs visual acuity score of ≥ 24 letters (i.e., 20/320 or better) and ≤ 73 letters (i.e., 20/40 or worse). * on clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula. * retinal thickness at the center point ≥ 250 microns. * media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs. exclusion criteria: * history of any vitreous hemorrhage within 4 weeks prior to visit 2 (day 1). * macular edema due to causes other than diabetic macular edema. an eye should be considered ineligible: (1) if the macular edema is considered to be related to cataract extraction or (2) clinical exam and/or oct suggests that vitreoretinal interface disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema. * an ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition). * an ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, age-related macular degeneration, uveitis or other ocular inflammatory disease, neovascular glaucoma, irvine-gass syndrome, etc.). * presence of any other condition or laboratory abnormality, which, in the opinion of the investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this phase 1 study.
endovascular exclusion of abdominal aortic aneurysms in high risk patients

Conditions: Abdominal Aortic Aneurysm; Iliac Aneurysm; Internal Iliac Aneurysm

Summary: the purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm exclusion using an endovascular prosthesis.

this study is a prospective, non-randomized evaluation of endovascular aneurysm repair in high-risk patients. the purpose of this study is to determine whether this endovascular prosthesis is safe and effective for the intended use of treating aaa/iliac aneurysm in patients who are at high risk for standard aneurysm surgical repair. up to 400 patients will be enrolled at the cleveland clinic foundation. baseline procedures may include angiogram, intravascular ultrasound, ct scan, physical exam, blood work and ankle-brachial index. the endovascular prosthesis is placed in the operating room under regional or general anesthesia and the procedure length is approximately 2-3 hours. follow up evaluations will be done at 1 month, 6 months (if clinically necessary), 12 months and yearly, and may include a physical exam, ct scan, kub, ultrasound, blood work, and an ankle-brachial index.

Eligibility criteria:
inclusion criteria: * the aneurysm is \>/= 5 cm or larger, or with a high risk of rupture due to its shape, history of growth, symptoms, or the presence of a large (\>2 cm) iliac aneurysm * anticipated mortality greater than 10 percent with conventional surgery * life expectancy greater than 2 years * suitable arterial anatomy * absence of systemic disease or allergy that precludes an endovascular repair * capable of giving informed consent and willingness to comply with the follow-up schedule exclusion criteria: * pregnancy * history of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately * allergy to stainless steel or polyester * unwilling to comply with the follow-up schedule * serious or systemic groin infection * coagulopathy, other than coumadin therapy * inability to give informed consent
safety, pharmacokinetics and pharmacodynamics of lgt209 in healthy volunteers with elevated cholesterol and in hypercholesterolemic patients treated with statins

Conditions: Hypercholesterolemia; LDL Cholesterol

Summary: this study is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of lgt209 in hypercholesterolemic patients taking common statin medications and in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy volunteers: male and female subjects 18 to 70 years of age, in general good health with fasting ldl-cholesterol \>90 mg/dl and fasting serum triglycerides \<400 mg/dl * patients on statin therapy: male and female patients 18 to 70 years of age receiving atorvastatin or simvastatin and with fasting ldl-cholesterol \>90 mg/dl and fasting serum triglycerides \<400 mg/dl exclusion criteria: healthy volunteers: * history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes * women of child-bearing potential unless using highly effective methods of contraception * conditions which might impact the safety or biologic activity of the study drug statin patients: * use of concomitant medications known to impact the safe use or efficacy of atorvastatin and simvastatin based on drug labels * women of childbearing potential unless using highly effective methods of contraception during dosing and for at least 100 days after study drug administration * conditions which might impact the safety or biologic activity of the study drug other protocol-defined inclusion/exclusion criteria may apply.

Keywords: hypercholesterolemia, ldl cholesterol lowering, proprotein convertase subtilisin/kexin type 9 (pcsk9), lgt209, drug safety, pharmacokinetics, pharmacodynamics
lish trial for the hepatic flexure and proximal transverse colon cancer

Conditions: Hepatic Flexure Colon Cancer; Proximal Transverse Colon Cancer

Summary: the goal of this clinical trial is to compare the long-term outcomes of laparoscopic ileocecal-sparing right hemicolectomy(lish) compared to traditional laparoscopic right hemicolectomy(trh) in the treatment of hepatic flexure colon cancer and proximal transverse colon cancer.

this study is a prospective, multicenter, open-labeled, randomized controlled clinical trial. the enrolled patients will be randomly assigned to either the lish or trh group in a 1:1 ratio and will receive the corresponding surgery. the primary endpoint: 3-year disease free survival. the second endpoint: (1)90-day postoperative complications; (2)pathology-related indicators, including positive margin rate, number of harvested lymph nodes and lymph node metastasis rate;(3) 5-year overall survival rate (os)

Eligibility criteria:
inclusion criteria: 1. age between 18-75 years old 2. asa classification ≤iii 3. colon adenocarcinoma confirmed by endoscopy and pathological biopsy 4. enhanced abdominal ct indicating the primary lesion is located in the hepatic flexure of the colon or proximal transverse colon (proximal 1/3 of the transverse colon) 5. preoperative clinical staging: tanynanym0 6. patients able to understand the study protocol, willing to participate in the research, and providing written informed consent exclusion criteria: 1. preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring bowel segment resection 2. preoperative imaging or intraoperative exploration reveals: 1) tumor involving surrounding organs requiring combined organ resection; 2) presence of distant metastasis; 3) inability to perform r0 resection; 4) fused and fixed lymph nodes at the root of the ileocolic vessels 3. additional radical surgery following endoscopic mucosal resection (emr) and endoscopic submucosal dissection (esd) procedures 4. history of any other malignant tumor within the last 5 years or familial adenomatous polyposis, except for cured in situ cervical cancer, basal cell carcinoma, papillary thyroid carcinoma, or skin squamous cell carcinoma 5. presence of bowel obstruction, bowel perforation, or intestinal bleeding requiring emergency surgery 6. patients unsuitable for or unable to tolerate laparoscopic surgery 7. pregnant or lactating women 8. patients with a history of psychiatric disorders 9. patients who have received neoadjuvant therapy prior to surgery 10. patients deemed unsuitable for the study by mdt discussion 11. patients unable to understand the study's conditions and objectives, and refusing to sign informed consent.

Keywords: hepatic flexure colon cancer proximal transverse colon cancer ileocecus-sparing laparoscopic right hemicolectomy
cells of monocytic origin as surrogate markers for individual drug effects and hepatotoxicity

Conditions: Drug-induced Disorder of Liver; Adverse Reaction to Drug

Summary: drug metabolism in the liver is subject to large fluctuations (differences between women and men, people of different ethnic backgrounds, children and adults). these large differences are responsible for very different drug effects and side-effects (and especially liver damage caused by drugs) between individuals. recent scientific findings suggest that blood derived cells can be used to model individual effects of drugs on the liver reflect inter-individual differences. since liver damage caused by drugs is a diagnosis of exclusion, the aforementioned cells can be used to identify patients that show higher sensitivity to hepatotoxic side-effects and - in case several drugs are involved - identify the causal agent or possible interactions.

drug-induced liver injury (dili), especially its idiosyncratic for is often an unpredictable complication of drug therapy. until now it is very challenging to predict occurrence, severity and outcome of dili. previous data provide evidence that cells from peripheral blood may reflect hepatocellular damage (fannin rd, hepatology. 2010). own research could show that peripheral monocytes are capable to obtain several hepatocyte-like functions while maintaining individual characteristics of the donor, especially cytochrome p450 metabolism (benesic, gerbes, et al, lab invest 2012). this study investigates the effects of potentially hepatotoxic drugs on cells generated from patient blood in comparison to the clinical presentation. its aim is the evaluation of in vitro tests using monocyte derived cells for diagnosis and exclusion of dili and the potential to use the patient derived-cells for mechanistic investigations of dili. 4 groups are investigated: 1) donors without liver disease 2) patients who will start a therapy with dili-potential; 3) dili patients; 4) patients with liver injuries other than dili. patient history and clinical data are obtained and a single blood sample will be collected after informed consent.

Eligibility criteria:
inclusion criteria: * age ≥ 2 years * informed consent given by the patient or in case of inability to give informed consent informed consent of the legally nominated consultee exclusion criteria: * anemia requiring blood transfusion * acute or chronic hepatitis b, c or human immunodeficiency virus infection * lack of informed consent
a study of adalimumab in japanese subjects with active ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: to evaluate efficacy, safety and pharmacokinetics of adalimumab in japanese subjects with active ankylosing spondylitis

it is reported that the prevalence of ankylosing spondylitis (as) in japanese patients is extremely lower than that of caucasians; therefore, a controlled, double-blind study with similar sample size in western studies for active as in japan was not able to be conducted. as a result, this study was conducted with an open-label design to investigate efficacy, safety and pharmacokinetics of adalimumab in japanese subjects with active as. the inclusion criteria and primary endpoint measurement (achieving assessment in ankylosing spondylitis 20 at week 12) were designed the same as the western studies for active as in consideration with the confirmation of western data. treatment with adalimumab was to be continued until the approval of adalimumab for as in japanese subjects with active as.

Eligibility criteria:
inclusion criteria: * subject who meets the definition of ankylosing spondylitis based on the modified new york criteria, has a diagnosis of active ankylosing spondylitis and has had an inadequate response to or intolerance to one or more nonsteroidal anti-inflammatory drugs exclusion criteria: * history of cancer, lymphoma, leukemia or lymphoproliferative disease, active tb, hiv * previously received anti-tnf therapy * spinal surgery or joint surgery involving joints to be assessed within 2 months prior to the screening

Keywords: ankylosing spondylitis