Kornimate/medical-research-clean huggingface dataset:
investigating effects of high-intensity gait training on gait, balance and depression post-stroke

Conditions: Stroke

Summary: the purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. the investigators want to know about improvements in participants' walking function and mental health after 20 interventions. the study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions.

the purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. the investigators want to know about improvement in participants' walking function and mental health after 20 interventions. the study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions. the findings from this study will help the researchers and clinicians decide how to help people with stroke better. further, the findings will determine how depressive symptoms, health literacy, and other factors such as language and education affect attendance to therapy. about 24 subjects will take part in this research.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * english or spanish speaking * a diagnosis of stroke (intracerebral hemorrhage or acute ischemic stroke) * referred to lvhn outpatient neurologic rehab (hereafter referred to as outpatient pt) exclusion criteria: * unable to follow 1-step commands * \> 220 pounds (100 kg) * height \ 6'4" * unable to take a few steps with assistance * a score of ≥ 50/56 on berg balance scale (bbs) * a score of ≥ 26/30 on functional gait assessment (fga) * resting blood pressure \>180/110 mmhg * resting heart rate \> 120 bpm * severe cardiac disease (new york heart association classification iv) * severe spasticity (modified ashworth score \> 3) * unstable spine or unhealed pelvic/limb fractures * active heterotrophic ossification impacting lower extremity range of motion * significant lower or upper extremity contractures * inability to achieve neutral ankle dorsiflexion with 12° of knee flexion * pregnancy * colostomy * poor skin integrity * unresolved deep vein thrombosis * lower limb prosthesis or amputation * leg length discrepancies \> 0.5 inches for upper legs, 0.75 inches for lower legs * rom restrictions preventing normal, reciprocal gait * inability to stand for \> 3 minutes due to pain or orthostatic hypotension * pusher syndrome * cortical blindness

Keywords: high intensity gait training stroke
thyroid dysfunction in patients with nephrotic syndrome

Conditions: Thyroid Dysfunction

Summary: this study is to evaluate thyroid hormone profile in patients with nephrotic syndrome to identify clinical predictor of thyroid dysfunction in patients with nephrotic syndrome

nephrotic syndrome (ns) is one of the most popular glomerular diseases all over the world it result in loss of various macromolecules which exist in the plasma and bound to plasma proteins. they are carried away and lost in the urine due to increase glomerular membrane permeability.the abnormalities arising as a result of persistence of generalized edema , substantial heavy proteinuria \>3,5 gm/24 h 3, hypoalbuminemia\<30 g/l and hyperlipidemia also, nephrotic syndrome may associated with thromboembolism and increase risk of infection, vitamin d deficiency, iron deficiency and endocrine abnormalities such as primary hypothyroidism.the interaction between kidney and thyroid hormone is an important factor in the normal functioning of both the vital organs, thyroid hormone play a major role in early development of kidney structurally and regulation of major glomerular and tubular function and water and electrolytes balance .kidneys on other hand are important in the metabolism and elimination of thyroid hormone.the effect of nephrotic syndrome on thyroid function can be explained by presence of proteinuria and loss of thyroid binding globulins (tbg) in urine which lead to decrease in total t3,total t4,free t3 and free t4 and consequently increase in tsh from the pituitary gland with over function of thyroid gland in order to maintain thyroid hormone levels. another theory explain association between nephrotic syndrome and thyroid dysfunction is autoimmunity which can attack both organs and may also cause abnormal function of both organs. thus, subclinical hypothyroidism and overt hypothyroidism may happen in ns patients and ckd patients

Eligibility criteria:
inclusion criteria: * nephrotic syndrome defined by the following: 1. generalized edema 2. urine protein excretion \> 3,5 g/24 hours 3. urine protein to creatinine ratio \> 3,500mg/g 4. serum albumin level less than 30 g/l exclusion criteria: - 1) patients \< 18 years old 2) patients who have thyroid diseases, current or past history of thyroid hormone or antithyroid drug intake. 3) patients who have diabetes mellitus or autoimmune diseases as systemic lupus erythematosus and ra 4) medications known to affect thyroid function. 5) patients with liver cirrhosis and chronic liver disease as augmentin
her-seq: a blood-based screening study to identify patients with her2 mutations for enrollment into clinical research studies of neratinib

Conditions: Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer; Metastatic Cervical Cancer

Summary: this is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the erbb2 (her2) gene, as measured in circulating tumor dna (ctdna) . participants with histologically confirmed, hormone receptor positive, her-2 negative, metastatic breast cancer (mbc) or metastatic cervical cancer (mcc) are eligible for screening at 6 months intervals, or if disease progression is suspected/confirmed. blood samples will be collected from eligible participants and ctdna will be extracted and sequenced at a central laboratory, using a her2-targeted next generation sequencing (ngs) test. a certified molecular test report will be issued from the central laboratory and provided to the investigators and the study sponsor. participants who are identified with her2 mutations by this screening protocol will subsequently have access to an appropriate neratinib treatment protocol, pending medical eligibility.


Eligibility criteria:
inclusion criteria: * women and men who are ≥18 years old at signing of informed consent * eastern cooperative oncology group (ecog) status of 0 to 2 * provide written informed consent to participate in the study and for circulating tumor dna screening * must be able to provide blood sample(s) for her2 mutation testing * participants with imaging or histologically confirmed, hr-positive, her2-negative mbc who are presently receiving or have received cdk4/6 inhibitor as a prior therapy in any setting, or participants with imaging or histologically confirmed metastatic cervical cancer * at least one measurable lesion, as defined by recist v1.1 exclusion criteria: * participants with breast cancer with known her2-positive or her2-amplified tumors * participants with breast cancer with hr-negative tumors * participants who have received her2-directed tki * participants with previously documented somatic kras activating mutation

Keywords: circulating tumor dna her2 genomic screening metastatic breast cervical erbb2 mutation cdk4/6 hr positive
a study designed to evaluate tear production

Conditions: Dry Eye Disease

Summary: the purpose of this study is to evaluate tear production following acute administration of ar-15512 ophthalmic solution 0.003% (0.003% ar-15512) in subjects with dry eye disease (ded).

qualified subjects will attend a single visit. this is a phase 3b. 2 stage study. in phase 1, approximately 40 subjects will be enrolled, after which the study will be paused and an analysis will be conducted. results from the stage 1 analysis will help inform the design of stage 2. an additional 40 subjects are planned for stage 2. for both stages, the primary endpoint and analysis will remain the same. stage 2 will be tested independently with no pooling of data between stages.

Eligibility criteria:
key inclusion criteria: * within the last 12 months, have a previous history of dry eye disease, either clinician diagnosed or patient reported. * within the last 6 months, have used, or desired to use artificial tears for dry eye symptoms. * have a corrected visual acuity score of 20/200 or better in both eyes. * have good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history. * other protocol specified inclusion criteria may apply. key exclusion criteria: * current evidence of any clinically significant ophthalmic disease other than dry eye (for example, glaucoma or macular degeneration). * history of ocular surgery within 1 year of the study visit. * use of contact lenses in either eye within 7 days of the study visit. * use of lid hygiene (all forms of lid care) or heat masks within 7 days of the study visit. * use of any topical ocular anti-inflammatory medications, any topical ocular corticosteroid, or any non-steroidal-anti-inflammatory agents within 30 days of the study visit. * other protocol-specified exclusion criteria may apply.

Keywords: dry eyes eye drops
enteroadsorbent polymethylsiloxane vs probiotic lactobacillus reuteri in the treatment of rotaviral gastroenteritis

Conditions: Rotavirus Gastroenteritis

Summary: this study evaluates a new drug, new enteroadsorbent polymethylsiloxane (enterosgel) in the treatment of rotavirus gastroenteritis in children. half of the participants received a new drug, polymethylsiloxane and half of the participants received standard treatment - probiotic l. reuteri (biogaia).

polymethylsiloxane and probiotic l. reuteri both hasten symptoms of the rotavirus gastroenteritis but they do so by a different mode of action. polymethylsiloxane is an enteroadsorbent and it possibly acts by adsorption of viruses and doing so it prevents binding rotaviruses for enterocytes. another mode of action can be forming a thin layer over the mucosal surfaces thus protects them from various damaging factors. probiotics help the healing of the intestinal mucosa presumably in few ways - by normalization of gut flora, by competition with pathogen bacteria for binding sites and nutrients and by stimulation of intestinal immune system.

Eligibility criteria:
inclusion criteria: 1. age 6-36 months 2. proven rotavirus gastroenteritis 3. symptom duration less than 48 hours 4. informed consent of the parents/caregivers exclusion criteria: 1. rotavirus vaccination 2. rotavirus infection in a patient's history 3. severe acute or chronic illness with possible influence on rotavirus gastroenteritis outcome
durable polymer-based stent challenge of promus element versus resolute integrity in an all comers population

Conditions: Acute Coronary Syndrome; Angina Pectoris; Angina, Unstable; Myocardial Infarction; Coronary Artery Disease; Coronary Stenosis; Coronary Restenosis

Summary: the introduction of drug-eluting stents (des) in the treatment of coronary artery disease has led to a significant reduction in morbidity but there are further demands on des performance. such demands are an optimized performance in very challenging coronary lesions; third generation des were developed in an effort to further improve des performance in such challenging lesions. two ce-certified third generation des (resolute integrity and promus element stents) are currently available; there are no data that indicate an advantage of one of these des over the other.


Eligibility criteria:
inclusion criteria: * minimum age of 18 years; * coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement; * patient is willing and able to cooperate with study procedures and required follow-up visits; and patient has been informed and agrees on the participation by signing an ec approved written informed consent. exclusion criteria: * participation in another randomized drug or device study before reaching primary endpoint; * planned surgery within 6 months of pci unless dual antiplatelet therapy is maintained throughout the peri-surgical period; * intolerance to a p2y12 receptor antagonist that results in the patient's inability to adhere to dual-antiplatelet therapy, or intolerance to aspirin, heparin, or components of the two des examined; * known pregnancy; * life expectancy of less than 1 year.

Keywords: drug-eluting stent zotarolimus everolimus all comers population target vessel failure coronary artery disease
safety and dose-escalation study of aav2-hchm in participants with chm (choroideremia) gene mutations

Conditions: Choroideremia; CHM (Choroideremia) Gene Mutations

Summary: this clinical study evaluates the safety and tolerability of aav2-hchm in participants with choroideremia gene mutations.

the primary objective is to evaluate the safety and tolerability of subretinal administration of aav2-hchm, in an inter-subject group dose escalation in individuals with choroideremia, based on a comprehensive clinical monitoring plan. the secondary objectives are to define the dose of aav2-hchm required to achieve stable, or improved, visual function/functional vision and to assess development of immune responses to adeno-associated virus vector, serotype 2 (aav2) and rab escort protein 1 (rep-1).

Eligibility criteria:
inclusion criteria: * male at least 18 years of age diagnosed with chm gene mutation * central visual field (vf) \<30° in any of the 24 meridians (using goldmann perimetry iii4e isopter) in the eye to be injected * any evidence of functioning outer retinal cells within the central 10° exclusion criteria: * previous history of ocular inflammatory disease (uveitis) * prior intraocular surgery within six months * participation in a previous gene therapy research trial within one year of enrollment or participation in any other ocular gene therapy trial * participation in a clinical study with an investigational drug in the past six months * grossly asymmetrical disease, or other eye morbidity, which may render the contralateral eye ineffective as a control * visual acuity \<20/200 on standard early treatment of diabetic retinopathy study (etdrs) testing in the eye to be injected * presence of disease which may preclude the participant from participation in this trial * use of medications known to be neuroprotective or retino-toxic that could potentially interfere with the disease process and/or cause ocular adverse events; individuals who discontinue use of these compounds for 6 months may become eligible * identification by the investigator as being unable or unwilling to perform/be compliant with study procedures.

Keywords: choroideremia aav gene therapy chm adeno-associated virus adeno-associated viral vector
pain related sexual dysfunction after laparoscopic inguinal hernia repair

Conditions: Sexual Dysfunction; Hernia, Inguinal; Other Chronic Postoperative Pain

Summary: previous studies have reported that about 3 % of patients who have had open inguinal herniorrhaphy had a visceral, ejaculatory-related pain. the investigators want to assess this problem among patients after laparoscopic inguinal hernia repair with(self-administered questionnaire study).


Eligibility criteria:
inclusion criteria: * male patients * \>18 yrs exclusion criteria: * research protection

Keywords: groin hernia chronic pain persistent postoperative pain laparoscopic inguinal herniotomy sexual dysfunction
effects of a dietary supplement on markers of glucose control and quality of life

Conditions: Blood Glucose

Summary: this study is a double-blind, randomized, two-arm, placebo-controlled trial of apparently healthy men and women to be recruited at a single investigational center in northeast ohio (i.e. the center for applied health sciences). subjects will attend four study visits. during visit 1, subjects will be screened for participation (i.e., medical history, physical exam, routine blood work \[also hga1c, insulin\], background baseline diet). over the next 12 weeks, subjects will attend visits 2-4, wherein assessments of serum glucose, insulin, homa-ir, 2-hour glucose tolerance test (gtt), hga1c, c-reactive protein, adiponectin, ferritin, waist circumference, quality of life questionnaire, and various visual analog scales for appetite, satiety, and cravings will be made.


Eligibility criteria:
inclusion criteria: provide voluntary signed and dated informed consent. be in good health as determined by medical history and routine blood chemistries. age between the ages of 21 and 65 (inclusive). body mass index of 18.5-34.99 (inclusive). body weight of at least 120 pounds. fasting blood sugar of 100-125 (inclusive) or hga1c of 5.7-6.4% (inclusive). normotensive (seated, resting systolic blood pressure \<140 mm hg and diastolic bloodpressure \< 90 mm hg. normal seated, resting heart rate (\<90 per minute). willing to duplicate their previous 24-hour diet, refrain from caffeine for 12 hrs and exercise for 24 hr prior to each trial, and fast for 10 hours prior each of the treatments. exclusion criteria: history of unstable or new-onset cardiovascular or cardiorespiratory disease. history of diabetes, or other endocrine disorder. fasting blood sugar of \> 125 mg/dl or hga1c of \> 6.4%. history of use of medications or dietary supplements known to affect glycemia or insulinemia. history of hyperparathyroidism or an untreated thyroid disease. history of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin). prior gastrointestinal bypass surgery (lapband), etc. other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. short bowel syndrome, diarrheal illnesses, history of colon resection, gastro paresis, inborn-errors-of-metabolism (such as pku). chronic inflammatory condition or disease (e.g. rheumatoid arthritis, crohn's disease, ulcerative colitis, lupus, hiv/aids, etc.). known sensitivity to any ingredient in the test formulations as listed in the certificates-of- analysis. currently participating in another research study with an investigational product or have been in another research study in the past 30 days. any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
neohepatic albumin-bilirubin scores on renal outcomes in living-donor liver transplantation recipients

Conditions: Acute Kidney Injury; Chronic Kidney Diseases; Graft Failure

Summary: this study investigates the association between post-reperfusion (neohepatic) albi scores and post-lt renal outcomes in living-donor lt (ldlt) recipients.

acute kidney injury (aki) after liver transplantation (lt) significantly affects patient and graft outcomes. the albumin-bilirubin (albi) score, an objective and sensitive index of liver function, has potential applicability in predicting outcomes following lt. this study investigates the association between post-reperfusion (neohepatic) albi scores and post-lt renal outcomes in living-donor lt (ldlt) recipients.

Eligibility criteria:
inclusion criteria: * living donor liver transplantation recipients (≥18 years) exclusion criteria: * preoperative serum creatinine (scr) \> 1.4 mg/dl, diagnosed ckd or hepatorenal syndrome (hrs), or hemodialysis at baseline
safety and tolerability of ranibizumab in mono/bilateral wet age related macular degeneration (w-amd) patients in eyes with bcva<2/10 and/or 2nd affected eye

Conditions: Wet Age Related Macular Degeneration

Summary: the purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wamd).


Eligibility criteria:
inclusion criteria male or female patients aged 50 years or above willing and capable to provide informed written consent eye(s) eligible for ranibizumab treatment, with a bcva below 2/10 due to wet amd and/or second eye eligible for ranibizumab treatment, with first eye treated (currently or previously) with ranibizumab, whichever bcva. in bilateral wamd patients, the second eye can be included only if the first eye has been treated at least 14 days before with ranibizumab exclusion criteria: active intraocular inflammation (grade trace or above) in either eye any ocular or periocular active infection (current or suspected), e.g. conjunctivitis, keratitis, scleritis, uveitis, endophtalmitis, in either eye risk factors for retinal pigment epithelial tear (including pigment epithelial retinal detachment) ocular disorders that may confound interpretation of results compromise visual acuity or require medical or surgical intervention during the study period including cataract, retinal vascular occlusion, retinal detachment or macular hole uncontrolled glaucoma in either eye (iop ≥ 30 mmhg on medication or according to investigator's judgment) history of vitrectomy in the study eye history of stroke or transient ischemic attack systemic treatment with any vegf inhibitor in the 90 days prior to study enrollment ocular treatment of the study eye with any anti-angiogenic drugs within 1 month prior to study enrollment any intraocular surgery in the study eye within 28 days prior to enrollment women of childbearing potential unless using effective contraception during treatment pregnant or lactating women simultaneous participation in a study that includes administration of any investigational drug known hypersensitivity to ranibizumab or any component of the ranibizumab formulation inability to comply with study procedures.

Keywords: wet amd macular degeneration ranibizumab mono-bilateral poor visual acuity retinal disease eye disease angiogenesis inhibitors angiogenesis modulating agents