Kornimate/medical-research-clean huggingface dataset:
using 16s rrna gene sequencing analysis intestinal microbiota in constipation patients

Conditions: Slow Transit Constipation

Summary: constipation is a frequent, chronic gastroenterological problem that has many varied symptoms and thus has several clinical definitions. according to the rome iii criteria for chronic constipation, almost 16% of all adults are affected by chronic constipation worldwide, and it is more prevalent and symptomatic in women and elderly people. slow transit constipation (stc) is the major category and is characterized by a decreased rate of colonic transit. recently, many researchers have focused on the relationship between intestinal microbiota and constipation and have demonstrated that intestinal microbiota contribute to the pathophysiology of functional gastrointestinal disorders. thus, there is a need for an improved understanding of gut microbiota composition in constipation patients and for the potential role played by the gut microbiota in the etiology of stc.to achieve this goal the investigators characterized and compared the intestinal microbiota among carefully selected patients with constipation that were clinically categorized based on rome iii criteria, and healthy controls using high throughput pyrosequencing of the 16s rrna gene and a conservative approach to detect quantitative changes in the relative abundances of taxa.


Eligibility criteria:
inclusion criteria: 1. chronic constipation according to rome iii criteria, defined as two or fewer spontaneous, complete bowel movements (scbms) per week for a minimum of 6 months; 2. age \> 18 years; 3. bmi: 18.5-25 kg/m2; 4. slow colonic transit confirmed by colonic transit test (colonic transit time (ctt) \> 48 hours); 5. normal anorectal manometry, with no evidence of dyssynergia and confirmed ability to expel rectal balloon; 6. no radiographic evidence of functional (i.e. pelvic floor dyssynergia) or anatomical (i.e. significant rectocele and intussusception) impediment to the expulsion of the radio-opaque contrast; 7. disease duration \> 1 year; 8. traditional treatment with dietary modification, laxatives (including osmotic and stimulant laxatives), and biofeedback tried over the past 6 months without success; exclusion criteria: 1. bowel constipation due to innate factor (i.e. megacolon) or secondary interventions (i.e. drugs, endocrine, metabolic, neurologic or psychologic disorders); 2. history or evidence of gastrointestinal diseases (i.e. obstruction, cancer, inflammatory bowel diseases) ; 3. previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section; 4. previous proctological or perianal surgery; 5. a constipation condition meeting the rome iii criteria for ibs or functional abdominal pain syndrome; 6. pregnant or breast-feeding women; 7. infection with enteric pathogen; 8. usage of probiotics, prebiotics and/or synbiotics within the last month; 9. usage of antibiotics and/or ppis within the last 3 months; 10. smoking or alcohol addiction within the last 3 months;
evaluation of clinical and microbial efficacy and safety of azasite compared to tobramycin for bacterial conjunctivitis (c-01-401-004)

Conditions: Bacterial Conjunctivitis

Summary: the purpose of this study is to evaluate the clinical and microbial efficacy and safety of azasite compared to tobramycin for bacterial conjunctivitis. adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. subjects will be randomly assigned to the azasite group or tobramycin group. three visits will be required for the study.


Eligibility criteria:
inclusion criteria: * male or female subject, of any race, who is at least 1 year of age. * subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye. * the symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less. * must be willing to discontinue contact lens wear for the duration of the study. exclusion criteria: * any uncontrolled systemic disease or debilitating disease. * use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study. * use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during study. * any active upper respiratory tract infection. * pregnant or nursing females. * use of any antibiotic (topical or systemic) within 72 hours of enrollment.

Keywords: bacterial conjunctivitis pink eye conjunctivitis eye infection
magnetic resonance (mr) conditional tachyarrhythmia therapy products post-approval study

Conditions: Tachyarrhythmia

Summary: following product approval, further confirmation of the mr conditional tachyarrhythmia therapy systems sensing and detection performance post mri exposure will be obtained by actively monitoring de-identified device data obtained through the medtronic carelink® network.

pre-clinical testing and clinical data has demonstrated the safety and effectiveness of magnetic resonance (mr) conditional tachyarrhythmia therapy systems in the mr environment when used according to labeling requirements. following approval, further confirmation of the mr conditional tachyarrhythmia therapy systems sensing and detection performance post mri exposure will be obtained by actively monitoring de-identified device data obtained through the medtronic carelink® network. mr conditional tachyarrhythmia therapy system enrolled in the medtronic carelink® network (cl) will be used to prospectively assess spontaneous ventricular fibrillation (vf) episode detection following mri exposure.

Eligibility criteria:
inclusion criteria: * mr conditional tachyarrhythmia therapy system enrolled in the medtronic carelink® network (cl) will be used to prospectively assess spontaneous ventricular fibrillation (vf) episode detection following mri exposure.
a clinical trial to compare efficacy and tolerability of faslodex with arimidex in patients with advanced breast cancer

Conditions: Metastatic Breast Cancer

Summary: the purpose of this study is to compare the efficacy and tolerability of faslodex (fulvestrant) with arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer.


Eligibility criteria:
inclusion criteria: * confirmed hormone receptor positive advanced breast cancer, postmenopausal women exclusion criteria: * previous treatment for advanced breast cancer (previous treatment for early breast cancer is allowed).

Keywords: oncology cancer breast cancer
impact of external drainage of the lumbar cistern in patients with hydrocephalus following meningioma surgery and its influence on patient satisfaction

Conditions: Investigate the Effect of External Lumbar Cistern Drainage in Preventing Postoperative Hydrocephalus in Patients Who Have Undergone Meningioma Surgery

Summary: this study aims to investigate the effect of external lumbar cistern drainage in preventing postoperative hydrocephalus in patients who have undergone meningioma surgery and its impact on patient satisfaction.


Eligibility criteria:
inclusion criteria: * diagnosis of meningiomas based on established diagnostic criteria and pathological confirmation * postoperative development of hydrocephalus, specifically communicating hydrocephalus * absence of other intracranial tumours or contraindications for surgery exclusion criteria: * concurrent mental disorders, coagulation dysfunction or organic diseases affecting other areas * hematologic diseases, severe liver or kidney dysfunction * patients discontinuing treatment or transferring to a higher-level hospital * a history of hydrocephalus, such as obstructive hydrocephalus
comprehensive approach to hypertension management in nepal

Conditions: Hypertension

Summary: hypertension is a global risk factor for cardiovascular diseases. approximately 80% hypertension burden is in low-and-middle income countries. hypertension can be managed with antihypertensive medication and following effective lifestyle interventions, however the control rate of hypertension among those on treatment is dismal. in nepal, a quarter of adult population have hypertension of whom, 44% are unaware of their status, 33% are on treatment, and, only 12% are controlled. a comprehensive intervention strategy for hypertension management has shown promising results in high income countries. therefore, it is of interest to understand its effectiveness, appropriateness and feasibility in the low income settings such as nepal. the objective of the trial is to assess the impact on net change in mean systolic blood pressure measured between 7 to 8 months follow-up of a comprehensive intervention which provides personalized counselling on lifestyle modification and medication adherence together with support for regular monitoring of blood pressure at home, compared with a control arm where hypertensive patients have access to routine care only. the investigators are proposing a cluster randomized controlled trial conducted in government health facilities from budhanilakantha, an urban municipality in the bagmati province of nepal. trial arms: 1) control (routine hypertension care); 2) comprehensive approach to hypertension management that includes blood pressure (bp) audit and feedback by physician (nurse and doctor), and patient support to monitor bp, and home based patient care by community health workers to encourage self-monitoring of bp followed by tailored educational counselling on behavioral and lifestyle change. eligible participants providing consent will be enrolled into the trial by a research assistant who will conduct interviews. those from the intervention arm will receive the home visits for 6 months. participants from both arms will provide follow up data in 7 to 8 months.


Eligibility criteria:
inclusion criteria: * hypertension patients (systolic blood pressure 140 mmhg or more and/or diastolic blood pressure 90 mmhg or more on at least two separate visits, or use of antihypertensive medication) * living in the area served by the participating health facilities exclusion criteria: * pregnancy * not able or willing to give informed consent, * critically ill from depilating conditions such as dialysis, cancer, palliative care * not likely to continue living in the area served by the health facility during trial follow up period (8 months)

Keywords: nepal monitoring
enhancing attention and wellbeing using digital therapeutics

Conditions: Aging; MCI; Cognitive Decline

Summary: the goals of the proposed research are to first determine the minimal and/or optimal dose of a digital intervention required for cognitive enhancement, and then to examine the impact of several potential moderators of treatment effects (i.e., cognitive decline, ad polygenic hazard score, cardiovascular risk, and race/ethnicity). this knowledge gained from his high-impact study with transform the field of cognitive interventions, paving the way for a precision medicine model for cognitive enhancing interventions that improve quality of life for older adults and individuals with cognitive deficits at risk of developing dementia.


Eligibility criteria:
inclusion criteria: * 60+ years old (adult) * english language fluency * owning a smartphone or tablet exclusion criteria: * under 60 years old (minor)

Keywords: healthy aging attention cognition dementia intervention digital behavioral prevention decline stress reduction quality of life
s9714: paclitaxel in treating patients with stage iiib or stage iv non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of chemotherapy with paclitaxel in treating patients with stage iiib or stage iv non-small cell lung cancer.

objectives: i. assess survival, progression-free survival and response rate of patients with bronchioloalveolar carcinoma receiving paclitaxel. ii. evaluate toxic effects of paclitaxel in 96 hour continuous infusion patients. outline: patients receive 6 cycles of paclitaxel by iv continuous infusion over 96 hours. before cycle 4, restaging is performed. if disease progression is witnessed, patients are removed from the study. if a stable, partial, or complete response is observed, patients receive the total of 6 cycles. three weeks after the last cycle, final restaging is performed. patients are followed every 3 months while on treatment and every 6 months thereafter, unless more frequent follow-up is clinically recommended. projected accrual: 50 patients will be enrolled. the accrual rate is estimated at 25 per year.

Eligibility criteria:
disease characteristics: histologically proven stage iiib or iv bronchioloalveolar non-small cell lung carcinoma -incompletely resected or unresectable -tumors may be multifocal or diffuse -measurable or evaluable disease required no prior brain metastases patient characteristics: age: 18 and over performance status: swog 0-2 life expectancy: not specified hematopoietic: absolute granulocyte count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than institutional upper limit of normal (uln) sgot no greater than 2 times uln renal: creatinine no greater than institutional uln or creatinine clearance at least 50 ml/min other: not pregnant or nursing effective contraceptive method used while on study no prior malignancies allowed, except: basal or squamous cell skin cancer in situ cervical cancer stage i or ii cancer which is in remission any cancer from which patients have been disease free for 5 years prior concurrent therapy: biologic therapy: no prior biologic therapy for lung cancer chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: no prior radiation therapy (including palliative radiotherapy) surgery: prior surgery is allowed

Keywords: recurrent non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer
effect of whole body vibration versus core stability exercises on balance and muscle strength in children with down syndrome

Conditions: Down Syndrome

Summary: children had down syndrome often have impaired balance and postural control and result as less active than their peers that can lead to reduced quality of life and movement skills. effects of physical activity may be important in preventing falling risk and health consequences in those children

sixty children from both genders (boys and girls) participated in this study, their ages ranged from 10 to 16 years and they were randomized into three groups of same number (a, b and c). groups (a) received conventional physical therapy program, group (b) received the same conventional physical therapy program of group (a) and core stability exercises while group (c) received the same conventional physical therapy program of group (a and b) and whole body vibration exercise

Eligibility criteria:
inclusion criteria: * aged between 10 to 16 years. * able to recognize commands given to them. * understand our verbal command and encouragement. * stand and walk independently without repeated falling. exclusion criteria: * children with any neurological (signs of epilepsy and instability of atlantoaxial joint). * musculoskeletal, or mobility disorders. * cardiac anomalies. * vision or hearing loss.

Keywords: children; core stability exercises; down syndrome; whole body vibration
evaluation of safety and efficacy of gene therapy drug in the treatment of spinal muscular atrophy (sma) type 1 patients

Conditions: Spinal Muscular Atrophy

Summary: the study will evaluate safety and efficacy of intrathecal delivery of gc101 gene therapy drug as a treatment of spinal muscular atrophy type 1 (sma 1) patients.

the purpose of this trial is to evaluate safety and efficacy of gene therapy drug gc101 in sma 1 patients. open-label, dose-escalation clinical trial of gc101 will be conducted in multiple centers in china. gc101 will be administrated intrathecally. short-term safety will be evaluated in 52 weeks and enter long-term follow-up study of 5 years at will. patients will be tested at baseline and followed up on various time points. the primary analysis for efficacy will be assessed when all patients reach 18 months of age on the motor milestone of sit unassisted for at least 10 seconds.

Eligibility criteria:
inclusion criteria: * six months of age and younger on day of vector infusion with type 1 sam as defined by the following features: * diagnosis of sma based on gene mutation analysis with bi-allelic smn1 mutations (deletion or point mutations) and 2 copies of smn2; * onset of disease before 6 months of age * the patient's legal guardian(s) must be able to understand the purpose and risks of the study and voluntarily provide signed and dated informed consent prior to any study-related procedures being performed. exclusion criteria: * patient who has participated in a previous gene therapy research trials; * patient who has received nusinersen and risdiplam treatment; * patient who has aav9 neutralizing antibody titer ≥1:200; * patient who requires non-invasive ventilatory support averaging≥16 hours/day; * patient with a point mutation in smn2 (c.859g\>c); * patient who requires non-invasive ventilatory support averaging≥16 hours/day at screening; * patient who use invasive ventilatory support or pulse oximetry \< 95% saturation while awake and calm at screening; * patient who is positive for human immunodeficiency virus (hiv) antibody, hepatitis b surface antigen, hepatitis c antibody, or treponema pallidum antibody; * abnormal laboratory values considered clinically significant, including gamma-glutamyl transferase(ggt), aspartate aminotransferase (ast), alanine aminotransferase (alt), bilirubin \> 3x upper limit of normal (uln), hemoglobin (hgb)\ 150 g/l, platelet \<183x10\^9/l or 614x10\^9/l; * class iv patient based on modified ross heart failure classification for children; * patient with a history of glucocorticoid allergy; * contraindication that would interfere with the lumbar puncture procedures; * presence of an untreated active infection requiring systemic antiviral therapy at any time during the screening period; * vaccination less than 2 weeks before infusion of vector; * patient who has any concurrent clinically significant major disease or any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: type 1
apixaban dose reduction in patients with elevated drug levels

Conditions: Atrial Fibrillation

Summary: apixaban is an anticoagulant which is increasingly being used to prevent stroke in atrial fibrillation (af). phase iii clinical trials have demonstrated that apixaban is efficacious and safe for the overall af population; however, patients older than age 85, with creatinine clearance \ 85, creatinine clearance \<40ml/min, or weight \<50kg - who are also at increased risk of having elevated drug levels due to these clinical characteristics. participants will have apixaban levels measured, and those with persistently elevated levels will have their dose reduced. drug levels will be measured again after dose reduction to determine if the levels are reduced without becoming dangerously low.


Eligibility criteria:
inclusion criteria: * patients with non-valvular atrial fibrillation (permanent, paroxysmal, or persistent) receiving apixaban with any of the following characteristics: age\>85; creatinine clearance \<40ml/min; or body weight \<50kg. exclusion criteria: * inability to visit hamilton general hospital; * inability or unwillingness to provide written informed consent. * stroke or thromboembolic event in the past 6 months.
the role of fdg pet in radiation treatment planning for head and neck cancers

Conditions: Head and Neck Cancer

Summary: in patients with cancer of the head and neck and rectum, knowing the exact location of the tumor is important for designing the radiation field to ensure delivery of high dose of radiation to the tumor while sparing surrounding normal tissues. a new medical imaging method which is a combination of positron emission tomography (pet) and computed tomography (ct) scan, has shown promise in helping the radiation oncologist in defining the exact location and extent of the tumor in certain cancers such as lung cancers. therefore the purpose of this study is to determine if these imaging methods can be used in combination with the standard radiation treatment planning procedure to improve the accuracy to targeting your tumor with radiation. in addition the pet-ct scan, similar to the pet scan alone with better resolution, can be used to determine whether the tumor has spread to any part of the body outside of the head and neck sites.


Eligibility criteria:
inclusion criteria:patients who are scheduled to receive radiation therapy for head and neck cancer at stanford. exclusion criteria:non-stanford patients.
study of the effects of muscular activity on iron metabolism

Conditions: Iron Overload; Iron Deficiency

Summary: the aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. fourteen healthy male subjects will have to pedal on an ergocycle for 45 minutes, and urine and blood samples will be collected regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.

hemojuvelin has been described as interfering with hepcidin, a key regulator of iron homeostasis. hemojuvelin is mainly produced by muscle, and the relationship between exercise and iron metabolism can be questioned about. the aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. fourteen healthy male subjects will be investigated at two periods according to a cross-over design after: 1. 45 minutes of exercise on the ergocycle; and 2. no physical exercise. urine and blood samples will be collected at both periods regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.

Eligibility criteria:
inclusion criteria: * male individuals aged between 18 and 40 years old * body mass index (bmi) between 18 and 25 * normal at clinical examination * normal biological variables * written informed consent exclusion criteria: * mutation c282y of the hfe gene * iron metabolism abnormality * inflammatory syndrome * chronic pathology or ongoing treatment * tobacco smoking, alcohol consuming more than 30g/day * history of transfusion or blood-giving within 3 months * positive serology for hepatitis b virus (hbv), hepatitis c virus (hcv) or hiv.

Keywords: hepcidin hemojuvelin iron healthy volunteers
artelon metatarsophalangeal (mtp) spacer

Conditions: Osteoarthritis; Hallux Rigidus

Summary: the aim of this prospective, case series is to evaluate the surgical treatment of painful and disabling osteoarthrosis in the mtp-i joint by insertion of an artelon mtp spacer.


Eligibility criteria:
inclusion criteria: * the patient experiences pain and limitations of the great toe dorsiflexion at the mtp-i joint. * the patient has a clinically and radiographically verified arthritis in the mtp-i joint indicating the need for surgical treatment. * the patient reads, understands and is able to complete the study questionnaires in swedish. * the patient has received written and oral information regarding the study and has signed the informed consent form. exclusion criteria: * the patient has a pronounced hallux rigidus without mobility in the mtp-i joint (rom = 0°). * the patient has previously received surgical treatment affecting the anatomy of the mtp-i joint. * the patient has a systemic rheumatic disease, ongoing infection, hallux valgus or is seriously ill.