Kornimate/medical-research-clean huggingface dataset:
a study to determine the effect of multiple oral doses of slx-2119 in healthy male subjects

Conditions: Immune System Disorder (Healthy Volunteer)

Summary: the purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple doses of slx-2119 in healthy male participants.

duration per participants is day 1 up to 30 days after participant is treated with the last dose of study drug.

Eligibility criteria:
inclusion criteria: * healthy participants between the ages of 18 and 55 years, inclusive. * able to provide written informed consent prior to the performance of any study specific procedures. * body mass index (bmi) range of 19-30 kilogram per square meter (kg/m2), inclusive. exclusion criteria: * participants are excluded from the study if any of the following criteria apply: * past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety, or affect the pk evaluations. * known sensitivity to rho-associated coiled-coil containing serine/threonine protein kinases (rock2) inhibitor agents or to any of the constituents of the kd025 formulation. the above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
systematic review of antiretroviral treatments for chronic hepatitis b (chb)

Conditions: Hepatitis B, Chronic

Summary: the purpose of this study is to support the clinical value of entecavir by assessing the relationship between viral load and histological improvement.

systematic review of prospective clinical trials

Eligibility criteria:
inclusion criteria: * patients with chb diagnosis and no co-infection with hep a, hep c, hep d, or hiv * age 16 years or older * no post-transplant patients * rct, non-randomized trials, prospective cohort studies, prospectively analyses case series published since 2003 * at least one arm of trial must include monotherapy with entecavir, lamivudine, tenofovir, adefovir, or telbivudine * study arms must include at least 10 patients * follow-up of at least 48 weeks * published results available in english language exclusion criteria: * n/a
a phase ii trial of 72-hour continuous iv infusion of 9-aminocamptothecin with g-csf support in patients with advanced ovarian cancer previously treated with paclitaxel and cisplatin

Conditions: Ovarian Neoplasms

Summary: the objectives of this study are to determine the response rate to 9-ac in patients with advanced ovarian cancer who have recurrent disease after paclitaxel- and cisplatin-based chemotherapy regimens.

this is a phase ii study of 9-aminocamptothecin (9-ac), administered as an intravenous continuous infusion over 72 hours with g-csf support for patients with advanced refractory ovarian cancer. the objectives of the present study are to determine the response rate to 9-ac in patients with advanced ovarian cancer who have recurrent disease after paclitaxel- and cisplatin-based chemotherapy regimens.

Eligibility criteria:
disease characteristics: histologically proven, advanced epithelial ovarian cancer. histologic confirmation by pathology department, nih, required. recurrent disease after paclitaxel and either cisplatin or carboplatin. combination platinum/paclitaxel acceptable. bidimensionally measurable disease on physical exam, radiographs, or peritoneoscopy. repeat peritoneoscopy after 8 courses of therapy required if documentation of disease was solely by peritoneoscopy. laparotomy not required. no cns metastasis. no borderline or mixed histology. prior/concurrent therapy: see disease characteristics. more than 4 weeks since any prior therapy and recovered. no prior camptothecin analogue-based chemotherapy. no prior radiotherapy except intraperitoneal 32-p. patient characteristics: age: 18 and over. performance status: ecog 0-2. hematopoietic: wbc greater than 3,000. agc greater than 1,500. platelets at least 100,000. hemoglobin greater than 9 g/dl or; hematocrit greater than 27 g/dl. hepatic: bilirubin no greater than 1.5 mg/dl. serum transaminases no greater than 2 times normal. renal: 24-hour creatinine clearance greater than 45 ml/min (documented by nci investigator or primary care physician). cardiovascular: no myocardial infarction within 12 months. no active congestive heart failure. no heart block. no arrhythmia requiring medication. other: no active uncontrolled infection. no known hiv positivity. no second malignancy currently under treatment except: local basal cell carcinoma of the skin, cervical carcinoma in situ, other malignancies (e.g., stage i breast cancer) eligible at the discretion of the principal or associate investigators. no pregnant women.

Keywords: pharmacodynamic studies pharmacokinetics
reliability of ultrasound examination of the inferior caval vein

Conditions: Transthoracic Echocardiography

Summary: the purpose of this study is to compare validity of examination and measurement of inferior caval vein from different views in critically ill patients on mechanical ventilation.

a maximal and minimal diameter of inferior caval vein will be measured by transthoracic echocardiography in critically ill patients on mechanical ventilation hospitalised in the intensive care unit from four different views: 1. subcostal view on the inferior caval vein in the long axis, 2. subcostal view on the inferior caval vein in the short axis, 3. right lateral view on the inferior caval vein in the long axis, 4. right lateral view on the inferior caval vein in the short axis. comparison between the results of measurements in the subcostal view in the long axis and other views will be performed.

Eligibility criteria:
inclusion criteria: * inpatients * patients on mechanical ventilation indicated for transthoracic echocardiographic examination exclusion criteria: * age \<18 years * insufficient imaging quality * refusal of echocardiographic examination by patient
24-week open label extension to a randomized, 6-week double blind, placebo controlled study, to evaluate the safety and tolerability of flexible doses of extended release oros® paliperidone in the treatment of geriatric subjects with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this open-label study was to evaluate the safety and tolerability of flexible doses of extended release oros® paliperidone in the treatment of geriatric subjects with schizophrenia after completion of the initial double blind study

the primary objective of the open-label extension phase was the long-term assessment of safety and tolerability of extended release (er) oros paliperidone (3 mg to 12 mg/day) in subjects (\>65 years of age) with schizophrenia, and the secondary objective was the assessment of long-term efficacy. paliperidone er oros® tablet formulation (3 to 12 mg/day) to be taken orally

Eligibility criteria:
inclusion criteria: * subjects who had completed the double-blind phase or discontinued due to lack of efficacy after at least 21 days of treatment, who signed the informed consent for the open-label phase, and who the investigator agreed that open-label treatment was in the best interest of the subject were eligible to participate in the open label phase exclusion criteria: * significant and/or unstable systemic illnesses * allergy or hypersensitivity to risperidone or paliperidone * significant risk of suicidal or violent behavior * biochemistry, hematology, or urinalysis results that are not within the laboratory's reference range, and that are deemed by the investigator to be clinically significant

Keywords: schizophrenia: paliperidone
comparative effects of dynamic and static stretching in postmenopausal females with knee osteoarthritis

Conditions: Postmenopausal; Knee Osteoarthritis

Summary: as the aging population continues to grow, there is a pressing need to explore effective interventions to alleviate the symptoms of osteoarthritis, particularly in postmenopausal women who may experience unique challenges. osteoarthritis (oa) is progressive joint disease characterized by joint inflammation and a reparative bone response and is one of the top five most disabling conditions that affects more than one-third of persons \>65 years of age, commonly affecting hands, feet, spine, hips, and knees. among the various therapeutic modalities, stretching exercises, both dynamic and static, have gained attention for their potential to enhance joint flexibility, reduce pain, and improve functional outcomes.

the study will be a randomized clinical trial and will be conducted in jinnah hospital, mafaza-tul-hayat hospital lahore and mayo hospital lahore. this study will be completed in time duration of 7 months after the approval of synopsis. non-probability convenience sampling technique will be used and 58 participants will be recruited in study after randomization. the subjects will be divided into two groups. group a will receive dynamic stretching of hamstrings and quadriceps with static stretching and group b will receive dynamic stretching without static stretching after warm up as baseline treatment. the tools that will be used are osteoarthritis outcome scale goniometer lower extremity function scale, strength, mmt, nprs, after data collection data will be analyzed by using spss version 21

Eligibility criteria:
inclusion criteria: * age 50 to 65 * diagnosed patients of oa with grade 3 * multiparous (5 children) * fertile females * pain greater than 6 on nprs exclusion criteria: * bmi \> 30 * early menarche ≤10 or 11 years. * cancer i.e breast cancer ,ovrian cancer * any bone deformity before menopause i.e limb length discrepancy, angulation

Keywords: pain postmenopausal knee osteoarthritis dynamic stretching static stretching
investigating therapies for freezing of gait

Conditions: Parkinson Disease; Gait Disorders, Neurologic

Summary: freezing of gait (fog) is arguably one of the most debilitating motor symptoms experienced by individuals with parkinson's disease (pd). fog may be caused by an overload of cognitive, limbic, and sensorimotor system activity in the basal ganglia. therefore, the purpose of this study is to evaluate cognitive, limbic, and sensorimotor therapies in individuals with fog. participants in this study will undergo all three types of treatments in a randomized counterbalanced order. each treatment will occur in 1 hour sessions, twice weekly for a period of 4 weeks.

freezing of gait (fog) is arguably one of the most debilitating motor symptoms experienced by individuals with parkinson's disease (pd), and negatively impacts quality of life (walton et al., 2015). furthermore, advanced fog does not respond well to treatments commonly used in parkinson's disease (nutt et al., 2011), therefore warranting the use of adjunct treatment options. the development of potential treatment strategies for fog should focus on the underlying mechanism. the cross-talk model of fog proposes that fog may be caused by an overload of cognitive, limbic, and sensorimotor system activity in the basal ganglia, resulting in a depletion of dopaminergic resources, leading to fog (lewis \& barker, 2009). hence, based on the cross-talk model, treatments targeting the cognitive, sensorimotor and limbic systems independently may lead to a reduction in fog episodes. previous studies have demonstrated the efficacy of therapies targeting these domains in pd and healthy individuals, however, these have yet to be explored in fog. therefore, the purpose of this study is to evaluate cognitive, sensorimotor, and limbic therapies in individuals with fog. this study will employ a within-subjects design, in which participants will undergo all three treatments in a randomized counterbalanced order. sessions for each type of treatment will occur for 1 hour, twice weekly for a period of 4 weeks. participants will also undergo pre- and post-test assessments prior to and following each 4-week treatment period. the cognitive training will utilize the "smartbrain pro" computer software, which has previously demonstrated efficacy in individuals with parkinson's disease (paris et al., 2011). the sensorimotor training group will participate in proprioceptive training of the upper and lower limbs. this training will entail a target matching task, in which participants will produce active and self-defined movements while blindfolded (i.e. without visual feedback). the limbic training group will undergo cognitive behavioural therapy (cbt) focusing solely on anxiety symptoms.

Eligibility criteria:
inclusion criteria: * either gender * diagnosed with idiopathic pd by a neurologist * self-reported fog with the use of updrs-ii (question 14) * confirmation of present fog by a movement disorder specialist * able to walk 10 meters, unassisted * able to understand english instructions exclusion criteria: * a neurological disease other than pd * peripheral neuropathy * clinically diagnosed with dementia
efficacy and safety of an ophthalmic solution in patients with allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate an ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the conjunctival allergen challenge (cac) model.

enrolled participants will be tested for the presence of common allergies using the conjunctival allergen challenge (cac) model. drops of increasing concentration of a solubilized allergen will be instilled in both eyes until a positive reaction occurred. the test will be repeated to confirm the allergic reaction. participants with confirmed reactions will be administered the test article (day 0) and undergo a cac 24 hours post-instillation (day 1). on day 14, participants will be administered the test article and undergo an additional cac.

Eligibility criteria:
inclusion criteria: * able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions. * negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period. * diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months prior to visit 1 or at visit 1. * history of seasonal or perennial allergic conjunctivitis for at least 1 year prior to visit 1. * best-corrected visual acuity of 55 or greater in each eye as measured by etdrs (letters read method). * manifest a positive bilateral conjunctival allergen challenge (cac) test response. * willing to discontinue contact lens wear for at least 72 hours prior to visit 1 and throughout the study. * other protocol-defined inclusion criteria may apply. exclusion criteria: * known history or presence of persistent dry eye syndrome, or currently requires frequent use of artificial tears, gels or lubricants, presence of punctal plugs, use of restasis®, or topical ocular corticosteroids for dryness of eyes. * presence of an ocular condition that may affect the study outcomes. * history or evidence of ocular surgery (including refractive procedures such as lasik, prk and rk) within 6 months of visit 1. * presence of signs/symptoms of active allergic conjunctivitis at the start of visits 1, 2, 3a, or 4. * history of anaphylactic reaction to any allergens used in this study. * current evidence or recent (within 6 months) history of severe, unstable, or uncontrolled medical conditions and/or other relevant systemic diseases. * use of any disallowed medication without protocol-specified washout period prior to visit 1, or during the study. * other protocol-defined exclusion criteria may apply.

Keywords: allergic conjunctivitis olopatadine hcl solution conjunctival allergen challenge itching eyes ocular allergies pataday patanol
68ga-fapi-04 pet/ct for the detection of oral carcinoma

Conditions: Oral Carcinoma

Summary: fapi is a fibroblast activation protein inhibitor and 68ga-fapi-04 is a potential new imaging agent for imaging of carcinoma. 68ga-fapi-04 pet/ct is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.

sometimes, the traditional 18f-fdg pet/ct diagnosis of head and neck tumors mistakenly diagnosed inflammatory lymph nodes as metastatic lymph nodes, resulting in false positive results. fibroblast activation protein (fap) is a serine peptidase on the surface of tumor associated fibroblasts. it plays an important role in promoting the growth, invasion, metastasis and immunosuppression of tumor cells. fapi is a fibroblast activation protein inhibitor and 68ga-fapi-04 is a potential new imaging agent for imaging of carcinoma. 68ga-fapi-04 pet/ct is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.

Eligibility criteria:
inclusion criteria: * patients in suspicion of oral carcinoma, * 68ga-fapi-04 and 18f-fdg pet/ct within 2 week; * being able to provide basic information and sign the written informed consent form. exclusion criteria: * claustrophobia, * pregnancy, * breastfeeding, * kidney or liver failure, * inability to fulfill the study.

Keywords: pet/ct fapi
effects of a neuroad system, for the treatment of alzheimer disease

Conditions: Alzheimer's Disease

Summary: to evaluate the long-term efficacy of the neuroad system

to evaluate the long-term efficacy of the neuroad system in improvement of mild- to moderate alzheimer patients' cognitive function

Eligibility criteria:
main inclusion criteria: 1. male or female age 60-90 years 2. patients diagnosed with mild or moderate stage of alzheimer's disease, according to the dsm-iv criteria 3. mmse score 18 to 26 4. physical clearance for study participation as evaluated by the clinician 5. spouse, family member or professional caregiver agree and capable of taking care for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication) 6. informed consent by the patient or by legally authorized person if appointed main exclusion criteria: 1. cdr 0, 0.5 or 3 2. severe agitation 3. mental retardation 4. history of epileptic seizures or epilepsy 5. contraindication for performing mri scanning 6. contraindication for receiving tms treatment according to a tms questionnaire 7. patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth 8. cardiac pacemakers 9. implanted medication pumps 10. intracardiac lines 11. significant heart disease 12. currently taking medication that lower the seizure threshold

Keywords: tms cognitive stimulation neuroad
guideline to implementation: a rapid clinical care pathway to care for patients affected by chronic constipation

Conditions: Constipation

Summary: the study is being completed to test the pilot implementation of a rapid clinical care pathway for chronic constipation in the university of michigan gastroenterology clinic. this study will learn how often patients get better and how satisfied patients are with care decisions, when seen by a gastroenterologist for medical advice on constipation.

per the nih requirements the study team added the following language and also updated the registration to be an interventional study. the study will enroll adult patients with chronic constipation prior to appointment with a gastroenterologist that have not received anorectal function testing or treatment in the past. the study team will assess patients' constipation symptoms and then monitor whether providers order anorectal function testing or treatment as a primary outcome. source data will be derived from the medical record to provide quality assurance. the sample size is necessary to evaluate this outcome measure while accounting for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results. the statistical analysis plan will be descriptive with reporting of our binary primary endpoints given the nature of this being a pilot study.

Eligibility criteria:
inclusion criteria participants: * participant has chronic constipation as a main symptom * participant is able to participate in pelvic floor physical therapy exclusion criteria participants: * participant has taken narcotic pain medication in the past 30 days * participant has been scheduled for a test called an anorectal manometry in the past * participant has been scheduled to see a pelvic floor physical therapist in the past * participant is pregnant

Keywords: questionnaires gastroenterology care
improving gait in multiple sclerosis (ms) - strength training or treadmill walking?

Conditions: Multiple Sclerosis

Summary: the objective of this study is to evaluate the effect of strength training for the lower extremities and treadmill training on walking ability in persons with multiple sclerosis. the study is a randomized control trial with two groups and the intervention is 8 weeks of intensive strength training or treadmill walking. primary outcome measure is walking ability, secondary outcome measures are balance, work economy and strength.


Eligibility criteria:
inclusion criteria: * diagnosed with multiple sclerosis,classified as relapsing remitting,or primary/secondary progressive * expanded disability status scale (edss)score of ≤ 6 * reduced walking ability (subjectively experienced) exclusion criteria: * persons with a level of ataxia, clinically assessed, that would affect their ability to perform the training. * spasticity requiring stretching og treatment with baclofen. * other, not ms-related, conditions affecting walking ability.

Keywords: multiple sclerosis walking ability strength balance treadmill walking
sulodexide treatment in patients with dense deposit disease

Conditions: Dense Deposit Disease

Summary: the purpose of this study is to see if a medicine called sulodexide will help prevent or slow down the progression of membranoproliferative glomerulonephritis type ii/dense deposit disease. sulodexide is not yet fda approved and has not been studied in children. study aim/hypotheses: to measure the efficacy of sulodexide treatment in patients with the above disease/s.

study subjects will be asked to take sulodexide twice a day. the sulodexide will be taken in addition to the regular medications the subject is on. there will be no change in these other medications. the subject will also be asked to have blood tests each month to follow kidney function. the frequency of these tests is the normal/standard frequency for persons with mpgn ii/ddd and is neither increased nor decreased because of participation in this study. the study will occur over 6 months for each subject.

Eligibility criteria:
inclusion criteria: 1. patients must be 5 yrs. to 20 yrs. old 2. patients must have membranoproliferative glomerulonephritis type ii (mpgn2), also known as dense deposit disease (ddd) exclusion criteria: 1. patients less than 5 years of age or older than 20 years of age 2. patients who do not have a diagnosis of membranoproliferative glomerulonephritis (mpgn 2) also known as dense deposit disease 3. evidence of hepatic dysfunction including total bilirubin \>2.0mg/dl (34 micromol/l) or liver enzymes \>3 times upper limit of normal. 4. a history of any major medical condition (excluding ddd), including but not limited to: gastrointestinal bleeding in the past 3 months; hiv; active hepatitis b or c (current active disease defined as an abnormal liver biopsy or persistent, elevated transaminases, sgot, sgpt); and other medical conditions deemed serious by the investigator 5. any risk of bleeding, including a history of bleeding diathesis and a platelet count \<100,000/mm3 6. active cancer 7. participation in any experimental drug study in the 60 days prior to entry into this study; or plan to participate in any experimental drug study during the study period. 8. known allergy or intolerance to any heparin-like compounds 9. inability to give an informed consent or cooperate with the study personnel -