Kornimate/medical-research-clean huggingface dataset:
optimizing walking function of stroke survivors by a task-oriented home exercise program

Conditions: Stroke

Summary: in a randomized-controlled study, the effects of a structured, progressive, task-oriented home exercise program to optimize walking competency will be evaluated in subacute stroke survivors.

the majority of stroke individuals unable to reenter their previous community life after they have had a stroke. reintegration of community life by optimizing walking function is a major goal of stroke rehabilitation. because not widely available inpatient rehabilitation, discharged with incomplete recovery, limited numbers of technically trained physical therapists, financial saving, and transportation difficulty, home-based stroke rehabilitation setting has been interested in many developing countries. task- oriented exercise is well known and accepted approach to optimize walking function with underlying principles of motor control and motor learning theories. this approach has been used in the clinical setting with close supervision, but identification of appropriate protocol in the community environment is on progress. to date, no proper home exercise program based on task-oriental principle with minimal supervision for improving walking competency after stroke has been proposed in stroke rehabilitation. the purpose of this study is to investigate the effects of a structured, progressive, task- oriented home exercise program on walking competency in individual post stroke.

Eligibility criteria:
inclusion criteria: 1. either side of both type first stroke within 2 weeks to six months of onset with confirmatory diagnosis by ct scan and mri. 2. age between 40 to 65 years old. 3. moderate severity of stroke measured by the modified rankin scale (mrs- 3) 4. able to comprehend the instructions with good cognition measured by mini-mental state examination (mmse \> 23). 5. postadoption stage of readiness to change measured by the stages of change questionnaire (stage 4 and 5) exclusion criteria: 1. diagnosed with other neurological disorder such as parkinson's disease, peripheral nerve injury. 2. serious cardiac conditions (angina and myocardial infarction during the previous month, resting heart rate of more than 120, a systolic blood pressure of more than 180 mm hg, and a diastolic blood pressure of more than 100 mm hg) 3. fugl meyer assessment score (lower extremity) less than ≤ 21 4. significant hip, knee and ankle contracture that would limit ambulation (fugl meyer (rom) ≤1 in each joint). 5. orthopedic and rheumatological disorder with weight bearing pain (fugl meyer (pain) ≤ 1 in hip, knee and ankle joint movement).

Keywords: stroke task-oriented home exercise walking competency usual physiotherapy care
portal: patient-reported outcomes after routine treatment of atypical lesions

Conditions: Breast Cancer

Summary: this research study is evaluating how patients feel physically and emotionally after a prior breast biopsy for specific breast conditions (including atypical lesions such as atypical ductal hyperplasia (adh), atypical lobular hyperplasia (alh), lobular carcinoma in situ (lcis), and/or ductal carcinoma in situ (dcis))

the goal of this research is to better understand the experience of women who have been diagnosed with certain breast conditions to enable women (and their doctors) to make informed decisions about their care.

Eligibility criteria:
inclusion criteria: patients treated at dumc, dfci, mdacc, mgh, nwh, or dfci @ ssh with a diagnosis of dcis, lcis, adh, or alh who are also: * age 18 or more at index diagnosis * diagnosed with dcis, lcis, adh, or alh between january 1, 2012 and june 30, 2017 * able to read either english or spanish and able to provide written (via paper), or on-line informed consent * treated and followed at one of the study sites (including affiliated network sites) and for whom treatment and surveillance data are available, for at least 1 year of follow up after date of diagnosis * participants with bilateral synchronous or metachronous disease (dcis, lcis, adh, alh) are eligible exclusion criteria: * ever had a diagnosis of invasive or microinvasive breast cancer * dcis prior to index lesion or history of progressive/recurrent dcis after treatment * other cancers (excluding non-melanoma skin cancer) diagnosed within 5 years prior to index lesion, including concurrent invasive cancer diagnosis and up to the present time of participant's approach to invitation into the study * patients identified by treating physician as being unsuitable for contact

Keywords: breast cancer
specific carbohydrate diet for clostridium difficile

Conditions: Clostridium Difficile Infection; Diet Modification

Summary: the investigators are doing this research study to answer questions about a nutritional therapy called the specific carbohydrate diet (scd) for children with active clostridium difficile infection. for this study, the investigators will be looking to determine: 1. is scd effective for the treatment for clostridium difficile colonization? 2. is the scd well tolerated?

the aim of this study is to determine the tolerability and potential efficacy of dietary therapy, the specific carbohydrate diet (scd), in pediatric patients with persistent antigen positivity due to c. difficile colonization with minimally active symptomatology. the goal of this pilot study is to gather preliminary data for a future treatment controlled trial of scd versus standard medical therapy. this is a single center, open labelled study designed to determine tolerability, preliminary safety and potential efficacy in pediatric patients with persistent c. difficile colonization with minimally active symptomatology. the study patients will be recruited from seattle children's gastroenterology and infectious disease clinic.

Eligibility criteria:
inclusion criteria: 1. children and adolescents eighteen months old to twenty one years old 2. diagnosis of c. difficile based upon stool antigen and toxin 3. minimally active symptomatology based upon 1. 4 or less stools per day 2. no evidence of dehydration 3. no evidence of bandemia or hypoalbuminemia on screening labs 4. parent/guardian and child must be able to comprehend the consent and assent 5. parent/guardian and participant must be able to attend study visits at baseline, and weeks +2, +4, +8, +12. 6. patient must not have had antibiotic treatment directed at c. difficile for at least 1 week. exclusion criteria: 1. severe symptoms 1. abdominal pain that interrupts or inhibits normal activity 2. fever 3. vomiting 4. blood in stool 2. clinical signs of coexisting acute systemic illnesses (meningitis, sepsis, pneumonia), immunodeficiency, underlying severe chronic diseases, and cystic fibrosis 3. tobacco, alcohol or illicit drug abuse 4. currently taking antibiotics at time of enrollment 5. malnutrition as judged by the ratio of weight to height, 6. clinical signs of dehydration(cd score\>0)

Keywords: specific carbohydrate diet clostridium difficile infection clostridium difficile cdiff diet
evaluation of zoledronic acid as a single agent or as an adjuvant to chemotherapy in high grade osteosarcoma

Conditions: Osteosarcoma

Summary: this trial will be a pilot study to find out if zoledronic acid improves the response to chemotherapy in high grade osteosarcoma. in arm a of the study, 40 adult patients will be randomised into two groups. one group will get standard chemotherapy and the other group will get zoledronic acid in addition to chemotherapy. the investigators will assess the histological necrosis as well as disease status for up to 2 years. in arm b, adult patients with relapsed disease or advanced disease who are unable to take any other therapy and are given only symptomatic care will be given 6 doses of zoledronic acid and followed up for disease status. this will be to determine the role of zoledronic acid as a single agent.


Eligibility criteria:
inclusion criteria: 1. adult patients (between the ages of 18 to 65 years) with a recently diagnosed high grade osteosarcoma of the extremity 2. non metastatic at presentation. the metastases are ruled out by a ct scan of the chest and a pet scan. 3. patients are willing and able to afford the standard chemotherapy. exclusion criteria: 1. non-extremity sarcomas. (pelvis and spine) 2. age less than 18 years or greater than 65 years 3. metastatic at presentation 4. pregnant or lactating women 5. renal dysfunction in the form of elevated serum creatinine 6. dental treatment anticipated after evaluation. 7. patients who have received or are likely to receive steroids.

Keywords: osteosarcoma zoledronic acid bisphosphonates adjuvant to chemotherapy
a proof-of-concept study of danicopan for 6 months of treatment in participants with c3 glomerulopathy (c3g)

Conditions: C3 Glomerulopathy; C3 Glomerulonephritis; Dense Deposit Disease

Summary: the primary purpose of this proof-of-concept clinical study was to evaluate the efficacy and safety of the study drug, ach-0144471 (also known as danicopan and alxn2040), in participants with c3g who also had significant proteinuria attributable to c3g.


Eligibility criteria:
key inclusion criteria: * had biopsy-confirmed primary c3g * had clinical evidence of ongoing disease based on significant proteinuria, attributable to c3g disease in the opinion of the principal investigator (pi), and present prior to study entry and confirmed during screening * was willing to comply with vaccination requirements. key exclusion criteria: * had a history or presence of any clinically relevant co-morbidities that would make the participant inappropriate for the study * had ever received danicopan * had more than 50% fibrosis or more than 50% of glomeruli with cellular crescents on the pre-treatment renal biopsy * had an estimated glomerular filtration rate \<30 milliliters/minute/1.73 meters squared at the time of screening or at any time over the preceding 4 weeks * was a renal transplant recipient or receiving renal replacement therapy * had a history of a major organ transplant or hematopoietic stem cell/marrow transplant * had evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which c3g is secondary * had other renal diseases that would interfere with interpretation of the study * had been diagnosed with or showed evidence of hepatobiliary cholestasis * females who were pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration * had a history of febrile illness, a body temperature \>38°celsius, or other evidence of a clinically significant active infection, within 14 days prior to study drug administration * had evidence of human immunodeficiency virus, hepatitis b infection, or active hepatitis c infection at screening * had laboratory abnormalities at screening that, in the opinion of the pi, would make the participant inappropriate for the study

Keywords: factor d fd alternative pathway complement mediated disease membranoproliferative glomerulonephritis primary mpgn mpgn mesangiocapillary glomerulonephritis idiopathic mpgn ddd c3gn
multi-center project: spinal abnormalities in neurofibromatosis type1 (nf1) patients

Conditions: Neurofibromatosis Type 1

Summary: we propose to establish a multi-center study to investigate the outcome of scoliosis and spinal abnormalities in patients with nf1. the three specific aims of this study are: specific aim 1 - to assess health status and health-related quality of life (hrql) in children and adolescents with nf1 and scoliosis. we hypothesize that children and adolescents with nf1 and scoliosis will experience an additional burden of morbidity due to scoliosis and a downward trajectory of health status and hrql over time. specific aim 2 - to assess the natural history and short-term response to therapy in a cohort of children with nf1 and scoliosis prospectively diagnosed during the course of the four-year study period. we hypothesize that some nf1 patients with idiopathic scoliosis will modulate to the dystrophic form. we also hypothesize that nf1 patients with earlier presentation are more likely to have or modulate to the dystrophic form. specific aim 3 - to assess biochemical markers of bone metabolism in nf1 individuals. we hypothesize that nf1 individuals will have statistically significant differences in biochemical markers of bone metabolism compared to controls. we also hypothesize that nf1 individuals with scoliosis will have differences in biochemical markers of bone metabolism compared to nf1 individuals without scoliosis.

the three specific aims of this study are: specific aim 1 - to assess health status and health-related quality of life (hrql) in children and adolescents with nf1 and scoliosis. we hypothesize that children and adolescents with nf1 and scoliosis will experience an additional burden of morbidity due to scoliosis and a downward trajectory of health status and hrql over time. specific aim 2 - to assess the natural history and short-term response to therapy in a cohort of children with nf1 and scoliosis prospectively diagnosed during the course of the four-year study period. we hypothesize that some nf1 patients with idiopathic scoliosis will modulate to the dystrophic form. we also hypothesize that nf1 patients with earlier presentation are more likely to have or modulate to the dystrophic form. specific aim 3 - to assess biochemical markers of bone metabolism in nf1 individuals. we hypothesize that nf1 individuals will have statistically significant differences in biochemical markers of bone metabolism compared to controls. we also hypothesize that nf1 individuals with scoliosis will have differences in biochemical markers of bone metabolism compared to nf1 individuals without scoliosis.

Eligibility criteria:
inclusion criteria: * meet nih diagnostic criteria for nf1 * radiographic documentation of scoliosis will be necessary for inclusion as a "scoliosis case" * age between 3 and 18 years exclusion criteria: * do not have nf1

Keywords: neurofibromatosis type 1 nf1 spinal anomalies
inclusion of elderly patients with colorectal cancer in clinical trials

Conditions: Colorectal Cancer

Summary: background: inadequate representation of elderly cancer patients in randomized clinical trials (rcts) leading to a lack of external validity thereby an uncertainty regarding benefit-risk balance of cancer treatment in elderly, especially chemotherapy. hypothesis: the eligibility criteria explain only a part of the under-representation of elderly patients in trials. we make the assumptions that 1) among the eligible, the invitation to participate in a trial and inclusion are inversely related to age, 2) among the eligible, there are patients, practitioner, or organization factors that would explain the non inclusion of elderly patients. objectives: 1) to assess, in elderly patients with colorectal cancer, the proportions of patients: 1. eligible at least to one rct 2. invited to participate 3. included 2) a) compare proportions among elderly patients to those of the comparator group of "young" subjects (age ≥ 18 and \<65 years) (added by amendment n°3 accepted 18/02/2014) b)to identify factors associated with the non-invitation and the non-inclusion in rct. material and methods: study design: a multicentric prospective cohort survey population: all patients aged 18 years or more (added by amendment n°3 - 02/2014) with a colorectal cancer followed in one of the participating centers. data collection: * at baseline: patient characteristics (including socio-demographic, oncologic and geriatric data) will be collected. organization factors (e.g. clinical research team) will be collected. * follow-up: the patient will be followed for potential invitation and inclusion in one rct. reasons of non-invitation or non-inclusion will be assessed. number of subjects needed: 696 (553 elderly patients and 143 "young" patients) number of centers : 7 (added by amendment n°3 - 02/2014) ethical aspects: each patient will give his oral informed consent. the international review board of mondor hospital (cpp ile-de-france ix) gave its approval in december 2012.


Eligibility criteria:
inclusion criteria: patient aged of of 18 years and older (modified by amendment n°3 - 02/2014) for a diagnosed colorectal cancer (crc) irrespective of the stage exclusion criteria: none

Keywords: colorectal neoplasms elderly randomized clinical trials inclusion.
buspirone treatment for marijuana dependence

Conditions: Marijuana Dependence

Summary: marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated pharmacotherapy treatments for marijuana dependence. this study will evaluate the efficacy of buspirone for reducing marijuana use in marijuana-dependent adults. a contingency management (cm) intervention and motivational enhancement therapy (met) will be incorporated to encourage study engagement and retention. it is hypothesized that buspirone combined with met and cm will reduce the percent of marijuana-positive urine drug screen results in marijuana-dependent individuals as compared to a placebo treatment combined with met and cm.


Eligibility criteria:
inclusion criteria: * must meet dsm-iv criteria for marijuana dependence. * must be between the ages of 18 and 65 years. * if female and of childbearing potential, must agree to use acceptable methods of birth control for the duration of the trial. * must consent to random assignment, and be willing to commit to psychosocial behavioral and medication treatment. * must be able to read and provide informed consent. exclusion criteria: * women who are pregnant, nursing, or plan to become pregnant during the course of the study. * must not have a history of or current psychotic disorder, bipolar disorder, or eating disorder. * must not pose a current suicidal or homicidal risk. * must not meet current criteria for major depression. * must not have evidence or history of serious hematologic, endocrine, cardiovascular, pulmonary, renal, gastrointestinal or neurologic disease. * must not require concomitant therapy with psychotropic medication. * must not be currently dependent on other substances, with the exception of nicotine or caffeine. * hypersensitivity to buspirone or any other product component. * patients who, in the investigator's opinion, would be unable to comply with study procedures or assessments, or would be unacceptable study candidates (e.g., poses threat to staff).

Keywords: marijuana buspirone contingency management motivational enhancement therapy
a study of pro95780 administered in combination with the folfox regimen and bevacizumab in patients with previously untreated, locally advanced, recurrent, and metastatic colorectal cancer (apm4566g)

Conditions: Metastatic Colorectal Cancer

Summary: this will be a multicenter, open-label study enrolling a total of up to 23 patients.


Eligibility criteria:
inclusion criteria: * histologically confirmed crc with evidence of locally advanced recurrent or metastatic disease and measurable tumor lesions * life expectancy \> 3 months * for patients of reproductive potential (males and females), use of reliable means for contraception throughout the trial and for 6 months following their final exposure to study treatment * willingness and capability to be accessible for study follow-up exclusion criteria: * prior 5-fu, capecitabine, and/or oxaliplatin treatment with the exception of: prior oxaliplatin treatment≤ 6 weeks in the advanced or metastatic setting; prior treatment with 5-fu, capecitabine, and/or oxaliplatin in the adjuvant setting if relapse occurred \> 6 months from concluding adjuvant therapy * peripheral neuropathy grade ≥ 2 * prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy * radiotherapy to a peripheral lesion within 14 days prior to cycle 1, day 1, or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to cycle 1, day 1 * chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to cycle 1, day 1 * evidence of clinically detectable ascites * other invasive malignancies within 5 years prior to cycle 1, day 1 * history or evidence upon physical examination of active central nervous system (cns) disease * current or recent participation in another experimental drug study * clinically significant cardiovascular disease, new york heart association (nyha) grade ii or greater congestive heart failure, serious cardiac arrhythmia within 1 year prior to cycle 1, day 1, or grade ii or greater peripheral vascular disease * active infection requiring parenteral antibiotics * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to cycle 1, day 1, fine needle aspirations within 7 days prior to cycle 1, day 1, or anticipation of need for major surgical procedure during the course of the study * known or suspected to be positive for the human immunodeficiency virus (hiv) * known to be positive for hepatitis c or hepatitis b surface antigen * inadequately controlled hypertension * prior history of hypertensive crisis or hypertensive encephalopathy * history of arterial thromboembolic event 6 months prior to cycle 1, day 1 * history of abdominal fistula or gastrointestinal perforation within 6 months prior to cycle 1, day 1 * bleeding diathesis or coagulopathy * pregnancy (positive pregnancy test) or breast feeding * serious, non-healing wound, ulcer, or bone fracture

Keywords: crc colon cancer avastin apm4566g
sustained oral fiber supplementation for patients undergoing donor stem cell transplantation for hematological malignancies

Conditions: Hematopoietic and Lymphatic System Neoplasm

Summary: this clinical trial examines sustained oral fiber supplementation for patients undergoing donor stem cell transplantation for hematological malignancies. patients undergoing donor stem cell transplantation often develop oral and gastrointestinal damage from chemotherapy, radiotherapy, or graft-versus-host disease. oral fiber nutrition support may improve overall nutrition, support a normal gut microbiome (bacteria that live in the gut) and/or improve gut function in patients undergoing stem cell transplants.

outline: current study design: patients receive fiber supplementation orally (po) or enterally starting 14 to 5 days prior to standard of care conditioning chemotherapy and continuing until discharge. patients who are not able to receive sufficient nutrition by mouth may receive parenteral nutrition or enteral nutrition by feeding tube from the hospital. patients may undergo blood sample collection throughout the study. previous study design: before this study was amended in january 2024, patients were randomized to 1 of 2 arms. previous arm i: patients received enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge. previous arm ii: patients received standard of care nutritional support. after completion of study treatment, patients are followed up at days 42, 60 and 90 days post transplant.

Eligibility criteria:
inclusion criteria: * able to provide written informed consent prior to initiation of any study procedures * planned allogeneic stem cell transplantation * at least 18 years of age exclusion criteria: * major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team * pregnant or breastfeeding. pregnancy test is obtained as part of pre-transplant evaluation in women of child-bearing potential at arrival to transplant and again within 7 days of conditioning and will be confirmed as negative by review of the chart