Kornimate/medical-research-clean huggingface dataset:
dronabinol for post-operative pain after lumbar fusion

Conditions: Post-operative Pain

Summary: impact of 2.5mg of oral dronabinol daily versus placebo on post-operative opioid consumption on patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion

this is a randomized double-blind clinical trial comparing 2.5mg of oral dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery versus placebo for patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion. the outcome of interest is post-operative opioid consumption defined as cumulative morphine milligram equivalents at 72 hours after surgery.

Eligibility criteria:
inclusion criteria: * age 18 to 65 years old * patients undergoing 1 to 3 level posterolateral fusion * opioid naïve or not * no prior spine fusion * willing and able to sign an informed consent exclusion criteria: * indication for surgery is fracture, tumor or infection * comorbid psychiatric diagnosis requiring therapy and/or medication * comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia) * has hepatic disease * on workers compensation/disability/litigation * known adverse reaction to medications to be administered * history of alcohol and drug abuse * on long-acting narcotic pain medication (including extended release narcotic pain medications and methadone)

Keywords: lumbar fusion post-operative opioid consumption post-operative pain
is the evaluation of anal distensibility by endoflip® technique useful for the diagnosis of anismus?

Conditions: Anismus; Distal Constipation

Summary: terminal constipation affects 13 to 20% of the french population. anismus is defined by an absence of relaxation or a paradoxical contraction of the striated anal sphincter muscle during defecation. anismus is one of the main causes of terminal constipation. anismus diagnosis is retained if 2 out of 3 examinations (manometry, electromyogram, defecography) are positive. endoflip® is a new medical device developed to measure distensibility of a hollow organ. anal endoflip® l could be a more sensitive and specific tool for detecting anismus in patients with distal constipation. 60 patients suffering from distal constipation will be included in order to perform, in addition to the usual examinations, an anal endoflip in order to test the sensitivity and specificity of this method for the diagnosis of anismus.


Eligibility criteria:
inclusion criteria: * patient older than 18 years * patient with distal constipation defined according to the rome iv criteria, for at least 3 months and verified by a transit time study showing a predominant slowing of markers at the recto-sigmoid level. * patient who read and signed the informed consent form exclusion criteria: * patients with a predominant right of left colonic constipation; * pregnant woman or woman with no effective contraception and of childbearing age * patient with inflammatory bowel disease, ischemic colitis, history of colon or rectal cancer, infectious colitis or proctologic disease. * patient with anorectal malformation * patient with an history of pelvic floor radiotherapy * patient with a digestive stoma * insertion of the probe impossible or painful * patient who has participated to a clinical trial within 30 days prior to the inclusion visit * patient not understanding or reading french * patients under guardianship, curatorship, safeguard of justice * patient without liberty by administrative or judicial decision
amlodipine and olmesartan medoxomil in hypertensive filipino patients

Conditions: Hypertension

Summary: the purpose of this study is to determine the safety, tolerability and efficacy of amlodipine and olmesartan medoxomil among hypertensive filipino patients.


Eligibility criteria:
inclusion criteria: * filipino hypertensive subjects ages 18-65 years old whether naive or currently taking any other anti-hypertensive or those on monotherapy using ccbs or arbs whom they want to shift on a fixed dose combination drug exclusion criteria: * patients with contraindications to any of the component of the fixed drug (amlodipine or olmesartan medoxomil) or with malignant or secondary hypertension

Keywords: hypertension fixed drug combination filipinos amlodipine olmesartan medoxomil uncontrolled hypertension difficult to treat hypertension
vision restoration training in glaucoma

Conditions: Glaucoma

Summary: importance: visual field loss after retinal damage in glaucoma is considered irreversible and methods are needed to achieve vision restoration. behavioral vision restoration training (vrt), shown to improve visual fields in hemianopia and optic nerve damage, might comprise such a method. objective: to determine if behaviorally activating areas of residual visual (arv) using vrt by daily one hour training for 3 months improves detection performance in perimetry compared to a vision discrimination task in the intact visual field sector.

design: prospective, randomized, double-blind, placebo controlled trial. setting: ambulatory care and home training participants: volunteer sample of glaucoma patients (25-80 yrs old) with stable visual fields and well controlled intraocular pressure (iop). intervention: computer-based home training with vrt (n=15) or placebo discrimination training (n=15). main outcome measures: the primary endpoint is change in detection performance in high resolution perimetry (hrp). secondary endpoints are 30° white/white and 30° blue/yellow near-threshold perimetry. further measures are eye movements, vision-related quality of life (vqol) as assessed with (nei-vfq) and health-related quality of life (hqol) using sf-36 health survey-short form. investigators hypothesize that vrt will improve visual performance in glaucoma

Eligibility criteria:
inclusion criteria: * visual filed defect caused by glaucoma * presence of a reproducible and stable visual field defect inside 30° eccentricity in at least one eye in 2 consecutive ophthalmologic visits during the last 12 months before recruitment * well controlled intraocular pressure (iop), and (iv) age between 25 and 80 years exclusion criteria: * history of any medical condition precluding scheduled study visits or completion of the study (e.g. unstable cardiovascular disease) * history of any chronic degenerative or chronic inflammatory disease that could affect the visual field (e.g. multiple sclerosis, tumor * history of trauma or any non-glaucoma ocular diseases (e.g. diabetic retinopathy, age-related macular degeneration, macular detachment, vascular occlusion * severe cognitive or motor impairments * insufficient fixation ability * photosensitivity * intraocular surgery or laser treatment performed within the previous 12 months before recruitment; or * scheduled intraocular surgery

Keywords: vision restoration visual field
effects of advanced glycation endproducts on satiety and inflammation

Conditions: Obesity; Type 2 Diabetes; Insulin Resistance; Cardiovascular Disease

Summary: the purpose of the meal study is to investigate acute effects on satiety and inflammation of advanced glycation endproducts (age) in healthy overweight subjects. the age content of the meal is affected by food preparation methods: frying/grilling versus boiling/steaming.


Eligibility criteria:
inclusion criteria: * healthy males and females between 20 and 50 years old * bmi 25-40 * waist circumference above 88 cm for women and above 102 cm for men exclusion criteria: * exercise training above 8 hour/week * smoking * pregnant or breast-feeding women * post-menstrual women * regular use of medicine (except contraceptive pills) * previous gastric bypass surgery * donation of blood within the last 3 months * involvement in other clinical trials * allergic to paraaminobenzoic acid

Keywords: advanced glycation endproducts satiety obesity inflammation insulin resistance
stent-related symptoms comparison: polaris loop vs vortek double-j stents

Conditions: Symptoms and Signs; Pain; Renal Calculi

Summary: prospective randomized controlled single-blind parallel-group trial in order to compare symptoms related to loop-tail (polaris loop) stents versus conventional double j (vortek) stents after uncomplicated flexible urs.

patients undergoing rirs for a single renal stone \< 2 cm are asked to participate in a prospective randomized controlled single-blind parallel-group study. ureteral stent is always placed after flexible urs. patients are prospectively randomized into two groups with a 1:1 allocation: group lt receive loop-tail stents (polaris ™ loop - boston scientific, natick, usa), while group dj receive conventional double j stents (vortek ® - coloplast, humlebaek, dk). stent removal is planned 4 weeks after the procedure. participants are asked to fill in the italian validated version of the ureteral stent symptoms questionnaire (ussq) 2 days and 4 weeks after surgery. the ussq is further submitted 4 weeks after stent removal (8 weeks after surgery) and these results are used as baseline evaluation, on the assumption that srs persist for a few days after removal.

Eligibility criteria:
inclusion criteria: * patients undergoing flexible ureteroscopy and laser lithotripsy for kidney stones \< 2 cm * given informed consent * who ps 0-2 exclusion criteria: * significant residual fragments at the end of the procedure * intraoperative complications (i.e. ureteral damage or ureteral stricture) * urinary tract infections * anatomic abnormalities * chronic diseases or medications potentially influencing pain perception and urinary symptoms (i.e. alpha blockers and antimuscarinics) * preoperative ureteral stenting.

Keywords: symptoms and signs pain renal calculi ureteral stent ureteroscopy
acceptability and feasibility of unsupervised hiv self-testing among networks of men

Conditions: HIV Infections; HIV/AIDS; Hiv

Summary: the purpose of this study is to recruit and train men to promote hiv self-testing to their network members in their camps and examine the efficacy of a peer-led hiv self-testing intervention on the uptake of hiv testing among men.

the research is the first evaluation of an unsupervised hiv self-testing strategy in tanzania focusing on networks of heterosexual men. the reasons for focusing on heterosexual men is because heterosexual contact is the primary mode of hiv transmission in tanzania and data from our previous trial indicate that 97% of the male camp members are heterosexual. moreover it will be the first intervention to engage male peer leaders to promote hiv self-testing in their social networks in tanzania. we will build on previous work our research team has conducted to identify 'camps' or local venues where young men socialize with elected leaders and members pay membership dues. our previous intervention has proven successful to recruit and train leaders from camps to serve as community health leaders in their respective camps, with the goal of changing social norms related to hiv and gender-based violence. a novel approach to the proposed research is that we will leverage the work we have conducted within camps with social networks of men to test the acceptability and feasibility of oral fluid-based hiv self-testing and confirmatory blood-based hiv testing within existing networks of men that we know we can access through stable social venues. we will recruit male camp leaders to train them about hiv self-testing and instruct them to return to their camps and engage their male peers by informing them about hiv self-testing for prior to our research team offering participants the opportunity to self-test.

Eligibility criteria:
inclusion criteria: * participant is at least 18 years old * has been member of the camp for at least 3 months * visits camp at least once a week * intends to live in dar es salaam for next 6 months * has not had suicidal thoughts in the past * willing to give contact information of self and relative or friend exclusion criteria: * does not meet all inclusion criteria * unable to participate due to psychological disturbance, cognitive impairment or threatening behavior
intellatip mifi xp ablation catheter trial

Conditions: Atrial Flutter

Summary: a study to assess the performance of a new catheter design for the treatment of atrial flutter.

a prospective, non-blinded, single arm, single center study designed to assess the performance of the intellatip mifi xp ablation catheter for the treatment of recurrent or sustained type i atrial flutter.

Eligibility criteria:
inclusion criteria: * 18 or older * indicated for ablation for atrial flutter exclusion criteria: * thrombus * recent mi/cardiac revascularization * prosthetic valves * recent ablation for atrial flutter * atrial flutter with reversible cause * class iv hf

Keywords: atrial flutter ablation type i atrial flutter atrial arrhythmia
a study to detect v-raf murine sarcoma viral oncogene homolog b1 (braf) v600 mutation on cell-free deoxyribonucleic acid (cfdna) from plasma in participants with advanced melanoma

Conditions: Metastatic Melanoma

Summary: this is a single arm, multicenter, open label, and non-randomized clinical study on adult participants with unresectable or metastatic melanoma. the study will be conducted in two phases. pre-screening phase will assess the braf v600 mutation in a new mutation analysis triggered by a mutant plasma cfdna test result. treatment phase will assess the clinical outcome for the participants treated with vemurafenib plus cobimetinib. the length of the study will be approximately 38 months.


Eligibility criteria:
inclusion criteria: pre-screening phase: * participants with histologically confirmed cutaneous melanoma, either unresectable stage iiic or stage iv metastatic melanoma, as defined by american joint committee on cancer 7th edition * documentation of braf v600 test result mutation-positive status on melanoma tumor tissue using a validated tissue test treatment phase: * eastern cooperative oncology group performance status of 0-2 * adequate hematologic and end organ function obtained within 14 days prior to first dose of study drug treatment * negative serum pregnancy test prior to commencement of dosing in women of childbearing potential * absence of any psychological, familial, sociological, or geographical condition that potentially hampers compliance with the study protocol and treatment regimen and follow-up after treatment discontinuation schedule * female participants of childbearing potential and male participants with partners of childbearing potential must agree to always use two effective forms of contraception during the course of this study and for at least 6 months after completion of study therapy * participants should be able to swallow tablets * documentation of braf mutation positive status in melanoma tissue exclusion criteria: treatment phase: * history of prior rapidly accelerated fibrosarcoma or mitogen-activated protein kinase pathway inhibitor treatment * use of prior chemotherapy or immunotherapy (including treatment with an anti-programmed death 1, or anti- programmed death ligand 1 or anti-cytotoxic t-lymphocyte-associated protein 4 monoclonal antibody) within 4 weeks before first study drug administration * palliative radiotherapy within 14 days prior to the first dose of study treatment * evidence of retinal pathology on ophthalmologic examination * systemic risk factors for retinal vein occlusion * history of clinically significant cardiac dysfunction * current severe, uncontrolled systemic disease * pregnancy, lactating or breast feeding * intake of st. john's wort or hyperforin (a potent cytochrome p450 3a4 \[cyp3a4 enzyme inducer\] and grapefruit juice (a potent cyp3a4 enzyme inhibitor) at least 7 days prior to initiation of and during the study treatment
the mckenzie method versus manipulation for patients with chronic low back pain

Conditions: Low Back Pain

Summary: introduction: the mckenzie method as well as spinal manipulation is commonly used for the treatment of low back pain throughout the western world. recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. the present study aims to compare the effectiveness of the mckenzie method and chiropractic manipulation, information, and advice for patients with clinical signs of persistent symptoms originating from a diskus in the low back. methods: after clinical screening 350 patients with or without leg pain who presented with centralization of symptoms or signs of disc herniation were randomized to the mckenzie group or the manipulation group. the outcome measures, roland morris disability questionnaire, 11 point numerical pain scale, 6 point global perceived change scale, and quality of life (short form-36) were assessed at baseline, at end of treatment, and at 2 and 12 months follow-up.

in 1998, cherkin et al. published a study showing no difference between outcomes following the mckenzie method, chiropractic manipulation, or the provision of an educational booklet for the treatment of patients with acute non-specific low back pain. recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. the present study aims to compare the effectiveness of the mckenzie method and chiropractic manipulation, information, and advice for patients with clinical signs of disc-related symptoms for duration of more than 6 weeks.

Eligibility criteria:
inclusion criteria: * 18 to 60 years of age * suffering from low back pain (lbp) with or without leg pain for a period of more than 6 weeks * able to speak and understand the danish language * with a presentation of clinical signs of disc-related symptoms. exclusion criteria: * positive non-organic signs * serious pathology suspected based on physical examination and/or magnetic resonance imaging * application for disability pension or pending litigation * pregnancy * comorbidity * recent back surgery * problems with communication

Keywords: low back pain intervertebral disc mckenzie physical therapy spinal manipulation chiropractics patient education exercise therapy random allocation
hemostatic forceps vs. bipolar electrocautery probes for high-risk bleeding gastroduodenal ulcers

Conditions: Gastroduodenal Ulcer

Summary: a randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patient with high risk bleeding gastroduodenal ulcers.

this is a prospective randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patients with high-risk bleeding gastroduodenal ulcers. the primary outcome is comparing the hemostatic rates of the devices. secondary outcomes are rebleeding rate at 7 and 30 days after index intervention, survival rate after intervention, procedure time for achieving hemostasis, number of units of infused blood, duration of hospitalization, and complications.

Eligibility criteria:
inclusion criteria: 1. the patient with upper gastrointestinal hemorrhage age ≥ 18 years old 2. the patient with gastroduodenal ulcer with indication for hemostatic intervention including 2.1 forrest classification 1a (active spurting) 2.2 forrest classification 1b (active oozing) 2.3 forrest classification 2a (non-bleeding visible vessel; nbvv) 2.4 forrest classification 2b (adherent clot) with lesion underneath clot which need hemostatic intervention including active spurting, active oozing or non-bleeding visible vessel exclusion criteria: 1. uncorrectable hemostasis laboratory including serum platelet \ 1.5 2. bleeding from cancerous gastroduodenal ulcer 3. the patient with history of gastric surgery 4. the patient with history of bleeding gastroduodenal ulcer within 30 days prior to enrollment 5. the patient with history of proton pump inhibitor allergy 6. pregnant 7. the patient deny to participate in the study

Keywords: hemostatic forceps bipolar electrocautery probes gastroduodenal ulcer rebleeding hemostasis peptic ulcer
lymphatic function in patients with a fontan circulation from brazil

Conditions: Univentricular Heart; Lymphatic Abnormalities; Lymphatic Edema

Summary: it is suggested that the elevated central venous pressure in patients with a fontan circulation can provoke manifestation of lymphatic dysfunction, met as plastic bronchitis, peripheral oedema and most feared protein-losing enteropathy (ple). an explorative study from our department at aarhus university hospital revealed that the function of the lymphatic vasculature in 10 young fontan patients with no complications was abnormal compared to healthy controls. however, to further describe and confirm these findings we had to investigate the lymphatic circulation in a larger, older and more complicated group of fontan patients. the hypothesis is that, patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature and which predisposes them to developing complications such as edema and ple.

the study population is patients with a fontan circulation followed at incor heart institute in sao paolo and ribeirão preto, brazil. these were matched with and group of healthy controls. the functional state of superficial lymphatics in the lower leg will be investigated, using near infrared fluorescence (nirf) imaging. the capillary filtration of fluid and leakiness of the capillaries will be measured using strain gauge plethysmography and the peripheral blood flow will be measured using venous occlusion plethysmography. furthermore, plasma concentration of noradrenaline will be estimated.

Eligibility criteria:
inclusion criteria: * fontan circulation * age above 16. exclusion criteria: * mental illness * syndromes.

Keywords: lymphatic dysfunction near-infrared fluorescence imaging fontan circulation plethysmography
evaluation of cross-linked polyelectrolyte (clp) in healthy volunteers

Conditions: Basic Science: Safety, Tolerability, Efficacy of CLP

Summary: this is a dose-escalation study to determine the effect of clp in normal healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy males or females between the ages of 18 and 70 years * body mass index (bmi) between 18 and 32 kg/m\^2, inclusive * females could not be pregnant or breast feeding and had to be using birth control exclusion criteria: * positive drug screen for substances of abuse * positive results for hiv, hepatitis b, or hepatitis c * screening 12-lead ecg demonstrating qtc interval \>430 msec for males and \>450 msec for females, or any cardiac rhythm disorder considered by the investigator to be clinically relevant

Keywords: clp
comparison of the swallowing functions in sarcopenia and dynapenia

Conditions: Sarcopenia; Dysphagia; Swallowing Disorder

Summary: the purpose of the study to investigate the comparison of the swallowing functions of the sarcopenia and dynapenia in older patients

sarcopenia is a geriatric syndrome; from skeletal muscle, and in its usefulness. dynapenia is a picture of sarcopenia without measurable muscle mass. it has been shown that dysphagia complaints are more common in patients with sarcopenia than in the normal population, but a comparison with patients with dynapenia has not been made to the best of our knowledge. according to the algorithm of the international society of physical and rehabilitation medicine (isprm), experts in the special interest group on sarcopenia, in the routine examination of patients aged 60-90 years who applied to the physical medicine and rehabilitation outpatient clinic with complaints of decreased muscle function, weakness, and slow movement, or "sarcopenia" or patients with "dynapenia" and patients without sarcopenia disease who volunteered to participate in the study will be included in the order of application to the outpatient clinic.

Eligibility criteria:
inclusion criteria: * age between 60-90 years * sarcopenia and dynapenia patients in study groups * non- sarcopenia and non-dynapenia patients in control groups * patients who were accept to consent form exclusion criteria: * severe sarcopenia patients * cognitive limitations * out of age 60-90 years old * patients who were not accept to consent form

Keywords: sarcopenia dynapenia swallowing deglutition dysphagia