Kornimate/medical-research-clean huggingface dataset:
hip-spine intervention for older adults with chronic low back pain

Conditions: Low Back Pain

Summary: low back pain (lbp) is extremely common in older adults and is associated with a host of negative consequences, including decreased physical function and increased healthcare utilization. among older adults with lbp, hip impairments indicative of hip joint disease are more prevalent and associated with greater disability than among older adults without lbp. this study will investigate a novel intervention designed to improve lbp-related disability by combining a typical spine-focused exercise program with a hip-focused intervention.


Eligibility criteria:
inclusion criteria: 1. age 60-85 2. low back pain for ≥ 3 months with pain of at least moderate intensity every day or almost every day that requires activity modification. 3. presence of at least 1 hip impairment denoted by the american college of rheumatology as potential indicators of hip osteoarthritis: hip pain, pain on hip internal rotation or morning stiffness of the hip of \<60 minutes. exclusion criteria: 1. previous hip fracture repair or total hip replacement 2. prominent component of radicular pain: clbp with distal radiation below the knee 3. known spinal pathology other than osteoarthritis: (e.g., a history of back surgery or recent trauma, spinal stenosis, vertebral compression fractures, ankylosing spondylitis, carcinoma metastatic to the spine) 4. non-ambulatory, or severely impaired mobility (i.e., require the use of a wheelchair) 5. folstein mini-mental state examination score of \<24 6. severe visual or hearing impairment. 7. red flags indicative of a serious disorder underlying the lbp: red flags that would require specialized medical attention include fever, significant unintentional weight loss, a sudden recent change in the character or intensity of pain, trauma that preceded the onset of pain, or signs and symptoms of caudae equinae (i.e. loss of sensation over saddle region, significant disturbances in bowel and bladder function). 8. significant pain in parts of the body other than the back or acute lbp. 9. acute, ongoing illness. 10. inability to participate in the study for the full six months for any known reason.(i.e. moving away, extended vacation) 11. received physical therapy for their lbp within in the last 3 months.
continued antiretroviral therapy with abacavir, amprenavir and efavirenz

Conditions: HIV Infection

Summary: this study will continue to treat and collect safety and efficacy data on patients who participated in glaxo-wellcome's multi-center study on combination therapy with abacavir, amprenavir and efavirenz (a phase ii study evaluating the safety and antiviral activity of combination therapy with 1592u89, 141w94 and dmp 266 (sustiva) in hiv-1 infected subjects with detectable \[greater than 400 copies/ml\] hiv-1 plasma rna despite treatment with a protease inhibitor-containing regimen). hiv-infected patients 18 years of age and older who participated in the above study at the nih site may be eligible for the current study. participants will be followed every 3 months with a general health evaluation and laboratory tests. this is a nih study, and information will not be provided to glaxo wellcome

in this open-label, single-arm study, hiv-1 infected patients who had, at study entry, a viral burden of at least 500 copies/ml despite 20 weeks of treatment with a protease inhibitor receive combination therapy with three antiretroviral agents that were investigational at the start of study but have since been approved: abacavir, amprenavir, and efavirenz. at the end of 16 weeks, the addition of other antiretroviral agents to the study regimen was permitted. this was originally a multi-center study, but it has been closed at all other sites. it remains open at the nih to continue to provide therapy to subjects who have received benefit as determined by a decline in viral load from baseline. safety and viral load data continue to be collected.

Eligibility criteria:
inclusion/exclusion criteria: subjects who were previously enrolled in this protocol when it was a multi-center study and who signed the new informed consent were enrolled. there has been and will be no other new enrollment. thus, subjects who were not previously enrolled are excluded. subjects are adults infected with hiv-1 who had, prior to study enrollment, a plasma viral load of at least 500 copies/ml despite at least 20 weeks of treatment with a protease inhibitor and without change in protease inhibitor therapy in the 12 weeks prior to enrollment.

Keywords: antiretroviral hiv-1 1592u89 141w94 dmp 266
pedicle screw positioning with myspine vs free hand technique

Conditions: Spinal Deformity

Summary: randomized clinical study in order to evaluate the accuracy of pedicle screw positioning during spine surgery performed with myspine patient match positioning guide or free hand technique.

the proposed study seeks to assess the intraoperative accuracy of the medacta patient-specific myspine® pedicle screws placement guides in comparison to free-hand technique. a pre-operative ct scan of the spine is obtained to create a 3-dimensional model of the patient's spine for the myspine patient group. this model is then used to preoperatively plan the patient's surgery implantation itself, with the same goals of both free-hand and computer assisted techniques. the theoretical advantage of this technique is accurate implant placement without the added surgical time and complexity of the procedure, with lower radiation exposure thanks to less steps of fluoroscopy checks. the hypothesis for the present study is that the myspine® technique can place pedicle screws more accurately in comparison to free-hand technique. the accuracy of the final implant position with respect to the pre-operative planning will be evaluated through ct post-op analysis.

Eligibility criteria:
inclusion criteria: * patients older than 12 years * patients suffering from coronal or sagittal spinal deformities that will undergo a surgical treatment with a posterior approach and pedicle screws placement * patients suitable to undergo spinal stabilization (according to the label indication/contraindications) * patients who are willing and able to provide written informed consent for participation in the study. written informed consent must be obtained when indication to surgery is confirmed. exclusion criteria: * patient with congenital spinal deformity (emeverebre, vertebra wedge, vertebrate butterfly, congenital bar, vertebra block) * patients with a previous fusion of the spine in the region where screws will be inserted * patients with any allergy to the device implanted * patients who will be not able to provide their written consent to the study participation * patients who are incapable of understanding and wanting
perception and multisensory integration in neurological patients using fmri

Conditions: Acute Inflammatory Demyelinating Polyradiculoneuropathy; Myasthenia Gravis; Stroke; Anosognosia; Asomatognosia

Summary: the main objective of the study is to explore and map brain areas involved in sensory perception and multisensory integration in patients with central or peripheral neurological damage. the investigators hypothesize for example, that a change (compare to healthy subjects) in the perceptual maps and body representation could be detected and characterize in patients suffering from impairments of peripheral nerve conduction.


Eligibility criteria:
inclusion criteria: * diagnosis of the investigated neuronal disease exclusion criteria: * contraindication for mri scan * pregnancy * refusal to participate in the study
the effect of liraglutide on body weight in obese subjects without diabetes

Conditions: Metabolism and Nutrition Disorder; Obesity

Summary: this trial is conducted in europe. the purpose of the 20-week trial is to investigate the efficacy of liraglutide to induce body weight loss and the purpose of the extension is to evaluate the long term safety and tolerability of liraglutide. trial has the following trial periods: a 20-week randomised, double-blind, placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open label orlistat comparator arm followed by an 84 week extension period.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) greater than or equal to 30.0 or lesser than or equal to 40.0 kg/m2 * stable body weight (less than 5% selfreported change within the last 3 months) exclusion criteria: * obesity induced by drug treatment * use of approved drugs for weight lowering intervention (e.g. orlistat, sibutramin, rimonabant) within the last 3 months prior to entering trial * type 1 or type 2 diabetes
clinical assessment of a motorized spinal distraction rod in the severe to early scoliosis child

Conditions: Scoliosis

Summary: the purpose of this biomedical research is to evaluate the feasibility of the treatment with the new spinal distraction device asts in patients aged 4 to 10 years with severe early onset scoliosis. the hypothesis of this project is that the new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications. the asts (for active scoliosis treatment system) growing rod is a new fully implantable motorized spinal distraction device which can ensure a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.

despite a better understanding and technical progress, the evolutionary early scoliosis remains a therapeutic challenge. the definition includes idiopathic scoliosis beginning before the age of 3 years, congenital scoliosis, neuromuscular and syndromic. spinal deformity is often progressive and may compromise cardiorespiratory function. the goal of treatment is to prevent further avoiding spinal fusion in a subject in growth. surgery is indicated in case of failure or cons-indication of conservative treatment (corset or plaster). the principle is to position the posterior rods subcutaneous or in muscle attached to two ends of the deformation. intraoperative distraction allows correction of the deformity. a new distraction is performed every 6 months until skeletal maturity. considerable complication rates are reported (58%), mainly implant infections and disassembly, because of the need for multiple reoperations. motorized implants can potentially avoid repeated interventions limiting complications. thus, the central hypothesis of this project is a new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.

Eligibility criteria:
inclusion criteria: * patient 4 to 10 years * patient weight between 15kg at 50kg * introducing severe scoliosis (cobb angle\> 40 °) with early onset * failed or cons-indication of conservative treatment (cast or brace) * agreement of parents or legal guardian (written agreement) and the patient (at least an oral agreement). exclusion criteria: * contraindication to surgery * age less than 4 years or above 10 years * weight less 15kg and above 50 kg
fluconazol versus medical honey in the treatment of recurrent vulvovaginal candidiasis

Conditions: Candidiasis, Vulvovaginal; Recurrent Candidiasis of Vagina

Summary: the purpose of this study is to compare the efficacy of flucanzol versus l-mesitran in the treatment of patients with recurrent vulvovaginal candidiasis. the investigator will look at vaginal swabs after 1, 6 and 12 months. the investigator included 252 patients.


Eligibility criteria:
inclusion criteria: * • women of at least 18 years old * recurrent vulvovaginal candidiasis (at least 3 episodes of clinical symptoms during the last year) * clinical and microbiological diagnosis of (recurrent) vulvovaginal candidiasis at time of consultation * capacity to understand, consent, and comply with the trial procedures exclusion criteria: * mixed vaginal infections * pregnancy or the intention to become pregnant during the study period * women using systemic or topical antifungal medication during the last 2 weeks prior to inclusion * known allergies for fluconazole or honey * candida with resistance for fluconazole

Keywords: treatment l-mesitran fluconazol vaginal swabs
reha drive: predictors of fitness to drive a car for cardiologic patients and determination of vital signs

Conditions: Cardiovascular Diseases

Summary: in this study predictors of fitness to drive a car in cardiologic patients after acute intervention and discharge from hospital to home or rehabilitation are determined in addition to possible automotive monitoring of vital signs via contact less sensors.

increasing numbers of elderly people with cardiovascular diseases and the wish to drive a car need recommendations corresponding to fitness of driving after their discharge from hospital to home or rehabilitation. a policy paper of the german cardiac society (dgk) of 2010 discusses the aptitude of driving a car of cardiovascular patients on experience but only little trial data.therefore predictors of reduced fitness to drive a car are determined via medical data in comparison to data elevated while "driving" in a simulator and evaluated via lane change test (lct). also monitoring of the fitness of driving in the car, automotive monitoring via contactless sensors, could be helpful for judgement.therefore possible evaluation of heart and breathing rate will be examined with contactless measurements via video camera.

Eligibility criteria:
inclusion criteria: * cardiologic disease after acute event (e. g. myocard infarction, bypass surgery, device implantation) * rehabilitation in clinic "an der rosenquelle" exclusion criteria: * dementia * lack of language ability * pregnancy

Keywords: myocard infarction arrhythmia fitness of driving
positive psychological intervention for parkinson's disease patients

Conditions: Parkinson

Summary: this study aims to evaluate the impact of positive psychological intervention based on the perma model on parkinson's disease patients by assessing their depression, quality of life, and related psychological indicators before and after intervention.


Eligibility criteria:
inclusion criteria: * subjects must meet the clinical diagnostic criteria for primary parkinson's disease * subjects must not have a history of depression or other significant illnesses (e.g., stroke, coronary heart and tumor disease) * subjects should have clear consciousness, effective communication capabilities, and basic comprehension and reading skills to complete routine assessments * the diagnosis of depression adhered to the ' chinese classification and diagnostic criteria for mental disorders ' (revised third edition) * subjectsshould not have schizophrenia * subjects should not have substance abuse (alcohol, tobacco or other psychoactive substances) exclusion criteria: * subjects with significant mental or cognitive impairment that communication or completion of scale assessments * subjects exhibiting severe self-harm or suicidal tendencies * subjects with severe dysfunction of the heart, liver, kidney or other critical organs * subjects with contraindications for transcranial magnetic stimulation (such as cochlear implant, pacemaker, built-in pump, artificial metal heart valve, suspected metal in the eye or elevated intracranial pressure) * subjects with a history of epilepsy that is poorly controlled * subjects with parkinson's disease who have undergone surgical treatment
phase 1 safety study of alrn-5281 in healthy subjects

Conditions: Growth Hormone Deficiency

Summary: the primary objective of this study is to evaluate the safety and tolerability of a single dose of alrn-5281 administered by subcutaneous injection to healthy adult volunteers.


Eligibility criteria:
inclusion criteria: 1. healthy male or female subjects aged 20 to 50 years, inclusive, at the time of informed consent. 2. subjects must be in good health as determined by the investigator based on detailed medical history, physical examination, vital signs, clinical laboratory tests, ecgs and other screening evaluations. 3. ability to provide written informed consent and complying with all study requirements and restrictions. 4. is a non-smoker and non-tobacco user for a minimum of 6 months prior to screening exclusion criteria: 1. history or current evidence of any clinically significant cardiac, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the investigator 2. previous treatment with any gh releasing hormone (ghrh) analog. 3. participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to enrollment. 4. history of cancer within the past five years (excluding non-melanoma skin cancer). 5. history of alcohol or drug abuse or dependence within 12 months of screening as determined by the investigator. 6. subjects with a body weight \> 120 kg.
newer versus older antihypertensive agents in african hypertensive patients (noaah) trial

Conditions: Blood Pressure

Summary: the purpose of this study is to compare the blood pressure lowering efficacy of a treatment regimen based on a dihydropyridine calcium-channel blocker combined with an angiotensin ii type-1 receptor blocker with the recommended treatment regimen based on a low-dose thiazide diuretic combined with a beta-blocker.

primary objective: sitting systolic blood pressure (average of three readings) will be the primary outcome variable. secondary 1. to compare the time interval between the two treatment groups, which after randomisation will be required, to reach and maintain the target defined as a blood pressure below 140 mm hg systolic and 90 mm hg diastolic; 2. to compare the duration of follow-up, during which a steady blood pressure control will be achieved; 3. to evaluate the incidence of adverse events, symptoms, biochemical abnormalities and ecg changes in the two treatment groups; 4. to assess the adherence to antihypertensive treatment as well as the rate of drop-outs in both treatment arms during a six-month period.

Eligibility criteria:
inclusion criteria: * women or men within an age range from 30 to 69 years with uncomplicated hypertension. * blood pressure measured in the sitting position after at least 5 minutes rest (average of three readings at the last run-in-visit) should range from 140 to 179 mm hg systolic or from 90 to 109 mm hg diastolic (grades 1 or 2 of hypertension). patients must have uncomplicated hypertension with a maximum of two additional risk factors, as defined in the 2007 guidelines of the european societies of hypertension and cardiology. * systolic blood pressure in the upright position must be at least 110 mm hg (mean of three readings obtained immediately after the patient has assumed a standing position). * patients who have never been treated for hypertension or in whom previous antihypertensive drug treatment has been discontinued for at least four weeks before the last run-in visit can be randomised. if two weeks after discontinuation of previous antihypertensive treatment the blood pressure is higher than 160 mm hg systolic or higher than 100 mm hg diastolic and if the patient has complaints, the patient can be randomised immediately to active blood pressure lowering treatment with either the newer or older antihypertensive drugs. * the patient must provide informed written consent. exclusion criteria: * premenopausal women not applying anticonception. * a history of cardiovascular disease. * secondary hypertension. * electrocardiographic left ventricular hypertrophy. * more than two cardiovascular risk factors in addition to hypertension. * diabetes mellitus. * renal dysfunction. * recent treatment with two or more antihypertensive drugs or a contra-indication to discontinue blood pressure lowering agents for 4 weeks. * severe non-cardiovascular disease. * known contra indications for the first-line study medications.

Keywords: blood pressure hypertension blacks africa blood pressure control side-effects
effects of victoza® versus lyxumia® on gastroesophageal reflux, gastric emptying and gastric acid secretion

Conditions: Diabetes Mellitus

Summary: the present study will compare lixisenatide and liraglutide in a population of subjects with t2dm not optimally controlled on oads and / or insulin, which is the target population for these medications.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. * male or female aged 18-65 years (both inclusive) * t2dm diagnosis exclusion criteria: * contraindications (including known or suspected hypersensitivity) to glp-1 mimetics * use of glp-1 mimetics or dpp-iv inhibitors * clinically relevant dysglycaemia as indicated by hba1c ≥ 10%
prevalence and characterization of persistent dyspnea after hospitalization

Conditions: Dyspnea; Pulmonary Disease

Summary: the investigators aim to make an overview of persistent dyspnea at the end of an hospitalization for a respiratory disease using an actual tool, the multidisciplinary dyspnea profile questionnaire.


Eligibility criteria:
inclusion criteria: * age over 18 years old * able to respond the questionnaire * presenting at admission a dyspnea over 3/10 on numerical analogic scale * admitted for a respiratory cause exclusion criteria: * cognitive impairment * aphasia * no french-speaking person
ventral mesh hernioplasty : laparoscopic versus open sublay

Conditions: Ventral Hernia

Summary: to compare between laparoscopic ventral hernia repair and open sublay technique (recurrence ,operative time ,bleeding ,rate of complication and injury , seroma, post operative pain)

a hernia usually happens in abdomen or groin, when one of your organs pushes through the muscle or tissue that contains it. most hernias eventually will need surgical repair. sublay mesh repair has the lowest recurrence and surgical site infection in open anterior abdominal hernia repair it is a perfect choice for the repair of ventral abdominal hernia the principles included two main steps: (1) mesh placement deep into the recti muscles and (2) mesh extension beyond the hernia defect. laparoscopic ventral hernia repair (lvhr) has established itself as a well-accepted option in the treatment of hernias. clear benefits have been established regarding the superiority of lvhr in terms of fewer wound infections compared with open repairs. meticulous technique and appropriate patient selection are critical to obtain the reported results. • in the laparoscopic technique, a prosthetic mesh is inserted through a trocar into the abdominal cavity and fixed against the abdominal wall. after reducing the hernia contents, the hernia sac is left unresected, and most surgeons do not place additional sutures for closing the hernia orifice. a specific risk of laparoscopic hernia repair lies in freeing adhesions between intestine and abdominal wall, which may result in (sometimes unrecognised) bowel perforation . the mesh should overlap the hernia orifice by at least 5 cm and is anchored to the abdominal wall with tacks, transfascial sutures, or a combination of the two methods. in laparoscopic abdominal hernia repair, mesh placement methods are generally classified into intraperitoneal onlay mesh (ipom), transabdominal abdominal preperitoneal (tapp)

Eligibility criteria:
inclusion criteria: * all cases of midline ventral hernia fit for surgery exclusion criteria: 1. surgically unfit cases 2. complicated hernia (obstructed ,irreducible, strangulated) 3. incisional ,massive ,recurrent hernias