Kornimate/medical-research-clean huggingface dataset:
l-citrulline in patients with post-polio syndrome

Conditions: Post-Polio Syndrome

Summary: the purpose of the study is to show that the intake of l-citrulline improves muscle function in patients with post-polio syndrome (pps).

this is a single center, randomized, double-blind, placebo controlled study. the study medication consists of l-citrulline, respectively placebo given orally; 5 g l-citrulline or placebo will be given three times daily. the duration of the study is 48 weeks and comprehends one screening and four study visits. additionally, in order to investigate whether pps is associated with an atrophy of spinal cord gray and potentially also white matter as well as motor cortex atrophy, it is planned to offer all trial participants an additional optional spinal cord/brain mri investigation and a mri at week 48 and a follow-up one year later together with a clinical and physiotherapy assessment during extension phase. we don't expect citrulline to affect the spinal cord gray or white and gray matter.

Eligibility criteria:
inclusion criteria: * prior paralytic poliomyelitis with evidence of motor neuron loss * a period of partial or complete functional recovery after acute paralytic poliomyelitis * slowly progressive and persistent new muscle weakness or decreased endurance, with or without generalized fatigue, muscle atrophy, or muscle and joint pain. symptoms that persist for at least a year * exclusion of other neuromuscular, medical and skeletal abnormalities as causes of symptoms * patients older than 18 years at time of screening * ambulant * ability to walk 150m in the 6 min. walking distance (6mwd) * females of childbearing potential willing to use contraceptive during the study exclusion criteria: * previous (3 months or less) or concomitant participation in any other therapeutic trial * use of l-citrulline or l-arginine within the last 3 months * known individual hypersensitivity to l-citrulline * known or suspected malignancy * other chronic disease or clinical relevant limitation of renal, liver, heart function according to discretion of investigator * pregnant or breast-feeding women * severe renal failure (calculated glomerular filtration rate (gfr) \< 30 ml/min)

Keywords: post-polio syndrome pps
standard duodenal switch vs. single anastomosis duodeno-ileostomy duodenal switch

Conditions: Obesity; Surgery; Metabolic Syndrome; Malnutrition

Summary: the aim of the torsby i trial is to identify differences and similarities between a standard duodenal switch (ds) and a single-anastomosis duodeno-ileostomy (sadi) regarding effect on weight, comorbidities and malnutrition.


Eligibility criteria:
inclusion criteria: * bmi over 45 * ability to understand the legal background of a study exclusion criteria: * previous bariatric or anti-reflux surgery * drug-abuse * inflammatory bowel disease * complex psychiatric situation
evaluation of implantable tibial neuromodulation (titan 1) feasibility study

Conditions: Overactive Bladder

Summary: this is a prospective, multicenter, feasibility study to characterize the procedure for the implantable tnm device in subjects with overactive bladder.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.)

Eligibility criteria:
primary inclusion criteria: 1. subjects 18 years of age or older 2. have a diagnosis for at least 6 months of oab 3. no oab pharmacotherapy for 2 weeks prior to the baseline voiding diary 4. willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system and comply with the study protocol 5. willing and able to provide signed and dated informed consent primary exclusion criteria: 1. have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury 2. severe uncontrolled diabetes 3. history of urinary retention within the previous 6 months 4. current symptomatic urinary tract infection 5. have primary stress incontinence or mixed incontinence where the stress component overrides the urge component 6. current urinary tract mechanical obstruction 7. have knowledge of planned magnetic resonance imaging (mris) or diathermy 8. history of a prior implantable tibial neuromodulation system 9. skin lesions or compromised skin integrity at the implant site 10. anatomical defects, clinically significant edema or previous surgeries which precludes use of the device 11. previous pelvic floor surgery in the last 6 months 12. women who are pregnant or planning to become pregnant 13. characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements. 14. any subject who is considered to be part of a vulnerable patient population. 15. concurrent participation in another clinical study that may add additional safety risks and/or confound study results.\*\* \*\*subjects in concurrent studies can only be enrolled with permission from medtronic. contact medtronic's study manager to determine if the subject can be enrolled in both studies.
exercise-induced hypoalgesia in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the main objective of this study is to evaluate the differences in the phenomenon of exercise-induced hypoalgesia in patients with osteoarthritis.


Eligibility criteria:
inclusion criteria: * diagnosed with severe knee oa (according to the clinical and radiographic criteria of the american college of rheumatology guidelines) exclusion criteria: * pain in the contralateral (non-studied) limb (maximum ≥80 of 100 mm on a visual analog scale (vas) during daily activities), * undergone another hip or knee joint replacement in the previous year * any medical condition in which exercise was contraindicated
trunk rehabilitation compared to core stability in patients with multiple sclerosis

Conditions: Multiple Sclerosis; Trunk; Physical Therapy

Summary: background balance, gait, community mobility, and risk of falls are often associated with trunk impairment among people with multiple sclerosis (pwms). consequently, there is a pressing need for interventions addressing these concerns and exploring the potential effects of trunk rehabilitation. long-term goal offering guidance for effective plan selection, potentially included in rehabilitation guidelines for pwms. hypothesis trunk exercises performed in multiplanar movement on unstable surfaces incorporated with dual-tasks (dt) could improve the functional outcomes more than standard one-plane core stability exercises. specific aims investigating the effectiveness of trunk rehabilitation in pwms and determining the optimal intervention strategy. methods 50 pwms randomly assigned into two groups. trunk group received trunk exercises on unstable surfaces with dt training, while the core group underwent standard one-plane core stability exercises on stable surfaces without dt. additionally, both received conventional treatment. primary outcome was the trunk impairment scale (tis). secondary outcomes included the berg balance scale (bbs), timed up and go (tug), modified falls efficacy (fes), modified fatigue impact scale (mfis), hospital anxiety and depression scale (hads), and reintegration to normal living index (rnli). significance enhancing our understanding of trunk exercises' benefits and providing valuable guidance to clinicians for choosing the optimal treatment plan.

there is a lack of comprehensive trunk rehabilitation protocols within the field of multiple sclerosis. the existing studies mostly focus on core stability, pelvic muscles, or alternative methods. consequently, the aim was to develop a protocol to investigate the potential positive effects of trunk rehabilitation. drawing from our review of relevant literature, investigators in this study have developed a trunk training protocol that focuses on multiplanar movements carried out on unstable surfaces and additionally, incorporated dual-task training (dt), which adds a layer of complexity.

Eligibility criteria:
inclusion criteria: * clinically diagnosed with ms (mcdonald's criteria) * able to walk 5 meters without assistance. * no relapse in the past 2 months. exclusion criteria: * recent surgery. * cognitive or psychological dysfunctions. * diagnosis of any other systematic disease.
low-dose theophylline as anti-inflammatory enhancer in severe chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the main objective of the study is to determine the effects of low-dose oral theophylline added to combination treatment with long-acting β-agonist (laba) and inhaled corticosteroid (ics) in patients with severe chronic obstructive pulmonary disease (copd) on the rate of exacerbations defined as increase of symptoms that requires a change of medication (antibiotics and/or systemic glucocorticoid) or hospitalisation. design: phase iii multicenter, randomized, placebo-controlled, double blind, parallel, prospective study. patient will be recruited during an hospitalisation due to copd exacerbation and randomised at the time of discharge to receive theophylline 100 mg or placebo on top of combination therapy with inhaled corticosteroids and long-acting beta agonist. the rate of exacerbations will be determined every three months up to one year follow-up. cl inic visits: every 3 months (total number of clinic visits = 4). in each of them, the following information will be obtained: * number/severity of exacerbations or hospitalisation since last clinic visit * compliance and side effects * blood sample * plasma levels of theophylline * sputum (induced) * mmrc * sgrq * forced spirometry + inspiratory capacity - at the beginning and at the end of the study * 6mwt * bmi * bode


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * ability to understand study procedures and to comply with them for the entire length of the study. * any gender. no contraception is required neither pregnancy expected in the range of age * age \> 45 years * smoking history \> 10 pack-years (current or ex-smokers) * clinical diagnosis of copd * presence of severe airflow obstruction on forced spirometry (fev1/fvc \< 0.7 and post-bd fev1 \< 50% of reference value) staged as gold iii or iv * diagnosis of copd exacerbation on discharge. exclusion criteria: * presence or history of other chronic respiratory diseases (asthma, bronchiectasis, tb lesions) * cancer * heart failure * pregnancy, or risk of pregnancy * other inflammatory diseases * previous treatment with theophylline * for drug studies: allergy/sensitivity to study drugs or their ingredients. * current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Keywords: copd
dabigatran etexilate vs enoxaparin in prevention of venous thromboembolism (vte) post total knee replacement

Conditions: Arthroplasty, Replacement, Knee; Thromboembolism

Summary: to determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery


Eligibility criteria:
inclusion criteria inclusion criteria 1. patients scheduled to undergo a primary, unilateral elective total knee repla cement. 2. male or female 18 years of age or older. 3. patients weighing at least 40 kg. 4. written informed consent prior to the start of study participation. exclusion criteria exclusion criteria 1. history of bleeding diathesis. 2. constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding. 3. major surgery or trauma (e.g. hip fracture) within the last 3 months. 4. recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrollment (investigator's judgment) or history of myocardial infarction within the last 3 months. 5. spinal or epidural anesthesia, for which more than 3 attempts (sticks) at placement were made, or the placement was traumatic. please note that patients, who are not excluded under this criterion, are to have the catheter pulled at the completion of surgery. 6. any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (av) malformation or aneurysm. 7. history of vte or pre-existing condition requiring anticoagulant therapy. 8. clinically relevant bleeding (e.g. gastrointestinal, pulmonary, intraocular or urogenital bleeding) within the last 6 months. 9. gastric or duodenal ulcer within the last 6 months. 10. liver disease expected to have any potential impact on survival (e.g. hepatitis b or c, cirrhosis, but not gilbert's syndrome or hepatitis a with complete recovery). 11. elevated ast or alt \>2x upper limit of normal, based on central lab results or local lab results within 1 month before enrollment. 12. known severe renal insufficiency (crcl \< 30 ml/min). in order to determine patient inclusion/exclusion, creatinine clearance (crcl) needs to be calculated only if serum creatinine is elevated or renal insufficiency is suspected.
anal fistula plug for high-type anal fistulae

Conditions: High-type Anal Fistulae

Summary: the aim of this pilot study is to evaluate the efficacy and safety of anal fistula plug in the management of high-type anal fistulae among hong kong chinese patients.

an anal fistula is an abnormal communication between the anal or rectal lumen and the perianal skin. anal fistulae are described according to the level at which they transgress the anal sphincter. if the internal opening begins above the anal sphincter then the fistula is described as 'high'. traditional surgery for high-type anal fistulae often requires staged operations with fistulotomy and seton insertion. the surgery usually results in large and deep wounds which can take months to heal. moreover, risk of faecal incontinence is inevitable because part of the anal sphincter is divided during the surgery. the surgisis® anal fistula plug is a minimally invasive and sphincter-preserving alternative to traditional fistula surgery. it is a newly developed biomaterial made from complex collagen obtained from pigs - animals that have a collagen structure almost identical to that of human tissue. during manufacturing of the plug, living cells are removed by special processes to help ensure that no transmittable diseases are present in the tissue. the plug is a conical device and is placed by drawing it through the fistula tract and suturing it in place. as pig collagen is so similar to human collagen, the plug, once implanted, incorporates naturally over time into the human tissue (human cells and tissues will 'grow' into the plug), thus facilitating the closure of the fistula. preliminary clinical data from usa showed a high fistula closure rate of 87%. the anal fistula plug can also avoid protracted postoperative wound care and minimise the risk of faecal incontinence. we would like to carry out a pilot study, the aim of which is to evaluate the efficacy and safety of this new anal fistula plug in the management of high-type anal fistulae. this is believed to be the first study of its kind in hong kong. patients with high-type anal fistulae confirmed by mri will be recruited into this study. patients with previous history of fistula surgery, patients with crohn's disease, and patients with known allergy to porcine material will be excluded. eua + anal fistula plug will be performed. outcome measures include fistula healing rate, recurrence rate, and morbidity. follow-up mri will be arranged at 3 months and 6 months after the operation to objectively evaluate the healing of the fistulae.

Eligibility criteria:
inclusion criteria: * patients with high-type anal fistulae confirmed by mri * informed consent available exclusion criteria: * patients with previous fistula surgery * patients with crohn's disease * patients allergic to porcine material

Keywords: anal fistula high-type anal fistula plug efficacy recurrence
identification of risk factors for acute coronary events by oct after stemi and nstemi in patients with residual non-flow limiting lesions

Conditions: Myocardial Infarction; Acute Coronary Syndrome; Coronary Artery Disease

Summary: the objective of this study is to compare the clinical outcome of non-st-elevation myocardial infarction (nstemi) and st-elevation myocardial infarction (stemi) patients with non-obstructive, non-culprit coronary lesions and either presence or absence of vulnerable plaque characteristics as assessed by optical coherence tomography (oct).

despite major advances in the treatment of acute coronary syndromes a large proportion of patients is still at risk for new coronary events after experiencing an acute coronary syndrome (acs). detection of residual vulnerable plaques after acs using oct potentially identifies patients at high risk for new coronary events. however, no prospectively collected data on the prognostic power of oct for plaque rupture are available at this moment. to design trials aimed to reduce events in patients with vulnerable plaques it is required to collect such prospective data on the relation between oct derived characteristics of vulnerability and clinical outcome.

Eligibility criteria:
inclusion criteria: * informed consent must be obtained. * patients with stemi or nstemi and residual, non-culprit cad, with the possibility of plaque vulnerability. * residual plaque(s) is(are) non-obstructive (ffr≥0.80). exclusion criteria: * refusal or inability to provide informed consent. * \< 18 years of age * hemodynamic instability, respiratory failure, kilip class ≥ 3. * previous coronary artery bypass grafting (cabg). * indication for revascularization by cabg. * anatomy or lesions unsuitable for oct catheter crossing or imaging (aorta-ostial lesions, small diameter segment, severe calcifications, lesion is too distal for oct catheter) * pregnancy. * estimated life expectancy \< 3 year

Keywords: vulnerable plaque optical coherence tomography oct
psychosocial mobile app for chronic graft-versus-host disease

Conditions: Chronic Graft-Versus-Host Disease; Allogeneic Stem Cell Transplant

Summary: the purpose of this research study is to see whether a psychosocial mobile app called horizons is effective at improving quality of life, symptom burden, psychological distress, and coping in patients living with chronic graft-versus host disease (gvhd)

frequently patients living with chronic gvhd experience physical and emotional symptoms during the course of illness that impacts their quality of life. patients also often report difficulty managing many of the tasks they need to do to manage their chronic gvhd. they also frequently have a lot of questions about chronic gvhd and the expected trajectory of this illness. the purpose of this research study is to see whether a psychosocial mobile app called horizons is effective at improving quality of life, symptom burden, and psychological distress in patients with chronic gvhd * this study will randomly assign participants to either receiving horizons plus usual care or usual care alone. * enrolled participants will be on the research study for up to sixteen weeks and it is expected that about 120 people will take part in this research study. the leukemia and lymphoma society is supporting this research by providing funding.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) who underwent allogeneic hematopoietic stem cell transplant (hct). * have moderate to severe chronic gvhd based on their oncology clinician assessment as documented in the electronic health record. * ability to comprehend and speak english as the horizons app is only available in english. exclusion criteria: -patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures.

Keywords: chronic graft-versus-host disease allogeneic stem cell transplant
the phosphodiesterase 4 inhibitor roflumilast as an adjunct to antidepressants in major depressive disorder patients

Conditions: Major Depressive Disorder

Summary: n pre-clinical studies and early-stage clinical trials, pde4 inhibitors such as rolipram have been shown to enhance memory. they also improve depressive-like behaviors induced by chronic unpredictable mild stress, lipopolysaccharide, or ethanol abstinence . consequently, it is reasonable to believe that pde4 is a potential target for treatment of the comorbidity of depression and ad.the aim of the current study is to evaluate the potential adjunct antidepressant effect of the phosphodiesterase-4 inhibitor roflumilast in adult patients with mdd.

phosphodiesterase-4 (pde4), an important member of the pde superfamily, is a key regulator of intracellular cyclic amp (camp) level. as the second messenger, camp activates protein kinase a, which phosphorylates the subsequent downstream camp-response element binding (creb) protein. in the central nervous system, this signaling cascade exerts both pre- and post-synaptic effects and is essential for a variety of cellular functions, including neurotransmitter release and neuroprotection. inhibition of pde4 prevents camp breakdown, which is well recognized as the mechanism by which pde4 inhibitors can treat impaired memory linked to several brain disorders. in pre-clinical studies and early-stage clinical trials, pde4 inhibitors such as rolipram have been shown to enhance memory. they also improve depressive-like behaviors induced by chronic unpredictable mild stress, lipopolysaccharide, or ethanol abstinence . consequently, it is reasonable to believe that pde4 is a potential target for treatment of the comorbidity of depression and ad. the aim of the current study is to evaluate the potential adjunct antidepressant effect of roflumilast in adult patients with mdd. furthermore, we will assess the relationship between ham-d score and bdnf as well as their role as a therapeutic targets of mdd.

Eligibility criteria:
inclusion criteria: • eighty adult outpatients with the diagnostic and statistical manual of mental disorders-iv (dsm-iv) diagnosis of mdd based on a mini neuropsychiatric interview (mini) (american psychiatric association., 2000; sheehan et al., 1998), without psychotic features and a total 17 item ham-d score of at least 20 with item 1 (depressed mood) scored 2 or greater were eligible (hamilton, 1960). exclusion criteria: * patients with bipolar i or bipolar ii disorder * patients with personality disorders * patients with eating disorders * patients with substance dependence or abuse * patients with concurrent active medical condition * patients with history of seizures * patients with history of receiving electroconvulsive therapy (ect) * patients with inflammatory disorders * patients with allergy or contraindications to the used medications * patients with finally pregnant or lactating females * cardiovascular disorders * severe renal impairment: creatinine clearance of ≤ 25 ml/min * moderate or severe hepatic impairment