Kornimate/medical-research-clean huggingface dataset:
cost effectiveness and efficacy of kyphoplasty and vertebroplasty trial

Conditions: Osteoporotic Vertebral Compression Fractures

Summary: randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.


Eligibility criteria:
* \> or = 50 years of age * compression fracture (t4-l5)within previous 12 mo. * pain from compression fracture * no malignant tumor * no back surgery
laser meridian massage in heroin addicts

Conditions: Heroin Dependence

Summary: a case-controlled study is conducted to investigate the effect of adjuvant laser meridian massage in heroin addicts with methadone treatment and establish the model of laser meridian massage treatment for drug addiction.

objective: to investigate the effect of adjuvant laser meridian massage in heroin addicts with methadone treatment and establish the model of laser meridian massage treatment for drug addiction. methods: a case-controlled study is conducted. fifteen male heroin addicts are enrolled from addiction treatment center as treatment group. they are treated with laser meridian massage on the back including bladder meridian and governor vessel three times a week for 4 weeks. a control group of participants without laser meridian massage treatment are matched by age. check urine morphine before, 2 and 4 weeks of treatment. subjects report their times or days of heroin use and self-fill visual analogue scales of heroin craving / refusal of heroin use (0-10 points) during last week before, 2 and 4 weeks of treatment. subjects report their quality of life using short form-12v2 before and 4 weeks of treatment. obtain the subject's pulse diagnosis and heart rate variability after a single treatment. independent t test, mann-whitney u test, chi-square test and fisher's exact test were used to compare the differences between the treatment and control groups. repeated measures anova, generalized estimating equations, paired t test and wilcoxon signed-rank test were used for comparison between the treatment and control groups.

Eligibility criteria:
inclusion criteria: * provide informed consent * male older than 20 years * diagnosed with opioid use disorder according to dsm-5 and received methadone treatment more than 1 month exclusion criteria: * received antidepressant or antipsychotic * received chinese herb or acupuncture treatment during last 30 days * critical illness * did not meet the physician's assessment for recruitment * patients with human immunodeficiency virus infection * did not provide informed consent

Keywords: laser meridian massage heroin addicts methadone treatment traditional chinese medicine
long term treatment of panic disorder with clonazepam or paroxetine

Conditions: Panic Disorder; Agoraphobia

Summary: the purpose of this study was to determine whether clonazepam and paroxetine are effective in the treatment of panic disorder. efficacy was evaluated in short-term, long-term and post-treatment.

the current study consisted of three steps. the first step was a naturalistic, prospective, randomized, open clinical trial with clonazepam and paroxetine. subjects received either flexible dose clonazepam (0.5 - 2 mg/day) or paroxetine (10 - 40 mg/day), in monotherapy for eight weeks. in the second step, those who responded to monotherapy in the short-term study continued with the same drug and dose. partial responders or non-responders were invited to receive combined pharmacological treatment with clonazepam and paroxetine. patients received the maximum tolerated doses of clonazepam and paroxetine. the doses were flexible, ranging from 0.5 to 2 mg/day for clonazepam and from 10 to 40 mg/day of paroxetine. all patients were treated for 34 months in the second step. patients who completed the second step and were in remission were included in the third step. for a period of four months all medications were tapered off. these patients were followed for 6 years with evaluations once a year. those who relapsed were treated on a naturalistic basis, with drugs or psychotherapy. this study was conducted in accordance with the ethical principles established by the declaration of helsinki and the brazilian national ethics committee (conselho nacional de ética em pesquisa - conep) guidelines. the local ethics committee approved the study protocol. written informed consent was obtained from all patients.

Eligibility criteria:
inclusion criteria: * diagnosis of panic disorder, with or without agoraphobia according to the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria, as determined by a structured clinical interview. * at least two panic attacks in the week preceding their inclusion in the study. exclusion criteria: * patients unable or unwilling to provide written informed consent. * did not complete all the evaluations before study initiation. * had comorbidities that could affect clinical evaluation including drug abuse, neurological disorders, or severe personality disorder.

Keywords: panic disorder agoraphobia clonazepam paroxetine
vitamin d and chronic renal insufficiency

Conditions: Vitamin D Deficiency; Chronic Renal Insufficiency

Summary: purpose of this study is to investigate the effect of treatment with vitamin d3 (cholecalciferol) compared with placebo in a trial including chronic kidney disease patients with vitamin d deficiency.

most patients with chronic renal insufficiency have vitamin d deficiency. it is still not common practice among nephrologists to monitor and correct vitamin d deficiency of chronic kidney disease (ckd) patients, because it is widely believed that any vitamin d deficiency associated with calcium-phosphate disturbances is better treated with activated vitamin d. however, correction of vitamin d deficiency with native vitamin d seems to have numerous favorable effects not only related to the renal and intestinal handling of calcium and phosphate. it may have beneficial effects on bone and vascular health, the immune system and physical performance that are not obtained with active vitamin d treatment. we are therefore planning a randomized, placebo-controlled, intervention study of 8 weeks' duration in which vitamin d3 supplementation (40 000 ie per week in one capsule) is compared with placebo in a trial including 120 ckd patients with vitamin d deficiency. multiple biological variables are monitored in order to assess any effect on the biological systems of interest.

Eligibility criteria:
inclusion criteria: * chronic kidney disease (ckd 3-5 amd renal transplanted patients) * age \> 18 years * vitamin d insufficiency or deficiency (25-ohd \< 50 nmol/l, 3 months before project start) exclusion criteria: * treatment with vitamin d2/d3 (dose more than 10000 iu within the last 3 months) * hypercalcaemia (ca++ \> 1,35 mmol/l more than 4 weeks despite missing intake of calcium containing preparations and activated vitamin d) * uncontrolled hyperphosphataemia (s-phosphate \> 2,2 mmol/l) * sarcoidosis * malignant disease * psychotic disorders * pregnancy and lactation women * allergy to soya and peanut

Keywords: renal insufficiency cholecalciferol kidney disease kidney failure vitamin d vitamin d deficiency vitamin d3
study to compare the efficacy of pristinamycin (pyostacine ®) versus amoxicillin in the treatment of acute community acquired pneumonia

Conditions: Pneumonia

Summary: primary objective: to evaluate the clinical efficacy of pristinamycin at a dose of 2g x 2/day for 2 days then 1g x 3/day for 5 to 7 days versus amoxicillin 1g x3 /day for 7 to 9 days, 5 to 9 days after the end of treatment. secondary objectives: to evaluate the clinical efficacy in a subpopulation bacteriologically documented at inclusion and according to procalcitonin level. to evaluate the efficacy of treatments against pneumococcus. to evaluate the rate of relapse and mortality 30±2 days after treatment is started. to document failures. to collect and follow up adverse events.

the total study duration for each patient is 1 month with a treatment period of 7 to 9 days and a follow-up period of 21 to 23 days.

Eligibility criteria:
inclusion criteria: male or female more than 18 years old with a presumed bacterial acute community acquired pneumonia presenting a port score of ii or iii (fine ii or iii). the acute community acquired pneumonia is defined by: * pulmonary x-ray (carried out within the 48 hours prior to randomization) showing new lobar or multilobar infiltrates. * at least 4 functional and/or clinical symptoms from among the following: * fever characterized by a temperature of more than 38.5 at least once within 24h prior to inclusion. * appearance or aggravation of a cough. * appearance of purulent expectoration. * appearance or aggravation of dyspnoea. * tachypnoea * chest pain * a characteristic sign on percussion and/or auscultation associated with a pulmonary condensation focus. exclusion criteria: patients having been diagnosed with legionellosis. patients having received systemic antibiotic therapy of over 24 hours within the week preceding the start of study treatment. associated neoplasm (active cancer \[of whatever type, solid or haematological\] or diagnosed within the year other than basocellular skin cancer). severe or very severe chronic obstructive pulmonary disease (copd) (gold3 and gold4). history of bacterial pneumonia in the past 12 months. bronchopulmonary diseases likely to interfere with the assessment of the therapeutic response. known hypersensitivity to streptogramins, penicillin and other betalactamines or excipients of the treatments studied. history of severe skin reaction after taking pristinamycin or amoxicillin. kidney disease (chronic kidney failure or creatinine clearance ≤30 ml/minute). patients treated with allopurinol, colchicine, immunosuppressants (cyclosporin, tacrolimus, mycophenolate mofetil, methotrexate, biotherapies) oral anticoagulants in the previous 6 months or during the study. known hiv infection, whatever the stage. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
study comparing in-laboratory polysomnography electrocardiogram (psg ecg) to simultaneously recorded in-laboratory ecg on the cpc m1 device

Conditions: Sleep Disorder

Summary: research study that will test a portable device (cpc m1) that records: body movement; heart activity (ecg; snoring; and body position during sleep. the food and drug administration (fda) has not approved this device for use except in a research setting. the purposes of this study are to: a) determine if the ecg data collected using the cpc m1 device is at least as good as the ecg data collected during a diagnostic, in-lab polysomnogram (psg) (or sleep study) and b) determine if in-home monitoring with the device will provide similar results compared to an in-lab psg.


Eligibility criteria:
inclusion criteria: 1. adults (males and females) 18 to 70 years of age with a suspected sleep disorder. 2. subjects or legal guardians are able to verbalize an understanding of the consent form, provide written informed consent, and verbalize willingness to complete study procedures. 3. adequate dexterity to apply and remove the cpc m1 device. exclusion criteria: 1. patients with atrial fibrillation and ventricular tachycardia. 2. patients with an inability to apply the cpc m1 device. 3. pregnancy.

Keywords: scheduled for a polysomnogram (overnight sleep study)
the fixation study

Conditions: Degenerative Conditions, Neurologic

Summary: to perform a clinical evaluation of safety and performance for the seaspine non- cervical pedicle screw systems

a multi-center, post-market, clinical evaluation for subjects implanted with the seaspine non-cervical pedicle screw systems

Eligibility criteria:
inclusion criteria: * have undergone surgery * have undergone at least 12-months of postoperative follow-up exclusion criteria: * any condition that the investigator determines is unacceptable
safety, tolerability, and pharmacokinetics of lumateperone in pediatric patients with schizophrenia or schizoaffective disorder

Conditions: Schizophrenia; Pediatric

Summary: study iti-007-020 is a phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and pk of lumateperone as treatment for adolescent patients with schizophrenia or schizoaffective disorder.


Eligibility criteria:
main inclusion criteria: * male or female patients between 13 and 17 years of age, inclusive * clinical diagnosis of schizophrenia or schizoaffective disorder according to diagnostic and statistical manual of mental disorders (dsm-5) * free from acute exacerbation of their psychosis for at least 3 months prior to screening * clinical global impression - severity (cgi-s) score ≤ 4 * body mass index (bmi) within 2 standard deviations of, age- and gender-specific body measurements (based on cdc clinical growth chart, 2000) * ability to swallow capsules main exclusion criteria: * has a primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder * reports having experienced suicidal ideation within 6 months prior to screening, any suicidal behavior within 2 years prior to screening based on the columbia-suicide severity rating scale (c-ssrs), and/or the investigator assesses the patient to be a safety risk to him/herself or others * clinically significant abnormality within 2 years of screening that in the investigator's opinion may place the patient at risk or interfere with study outcome variables * history of a clinically significant cardiac disorder and/or abnormal screening electrocardiogram (ecg) or a qt interval corrected for heart rate using fridericia formula \> 450 msec in males or \> 470 msec in females
inception, validation and clinical utility of a score to assess the completeness of caecal visualisation

Conditions: Colonic Polyp; Colorectal Cancer

Summary: ccis is a novel score, created specifically to evaluate the completeness of caecal visualized. it can be applied to a single or multiple images. to create the ccis, the caecum was divided into eight parts: the appendiceal orifice (ao), the tri-radiate fold part 1 (tf-1), 2 (tf-2), 3 (tf-3) and four outer quadrants (oq 1-4). the ileo-caecal valve (icv) is a reference point but is not part of the score. the quadrant adjacent to the icv is labelled oq1. the three other quadrants are labelled clockwise from this quadrant. the tri-radiate folds are also labelled clockwise with tf1 representing the triangle side that is majority-contained within oq1. tf2 and tf3 are then labelled clockwise from tf1.


Eligibility criteria:
inclusion criteria: * endoscopists \>18 years old exclusion criteria: * endoscopist not signing informed consent * any other medical doctor not connected with endoscopic practice
programmed death-ligand1 expression in her-2 positive and triple negative breast cancer

Conditions: Triple Negative Breast Cancer; HER2-positive Breast Cancer

Summary: patients with her-2 positive and triple negative breast cancer who received neoadjuvant chemotherapy will be included in the study. paraffin blocks of preoperative core or tru-cut biopsies of the participants will be collected and tested for programmed death-ligand 1 (pd-l1) expression. the variation of pd-l1 expression among different breast cancer subtypes will be evaluated and the investigator will correlate between pd-l1 expression and pathological complete response to neoadjuvant systemic therapy.

files of breast cancer patients attending breast cancer clinic at ain shams university clinical oncology and nuclear medicine department will be viewed by the investigator and those who fit the selection criteria will be included in the study. tru-cut or core tissue biopsies obtained from the participants for initial diagnosis will be collected and pd-l1 testing will be done on the specimens. scoring of pd-l1 will be done using combined positive score (cps) score. pd-l1 expression will be evaluated among her-2 positive and triple negative subtypes and will be correlated with pathological complete response after reviewing the postoperative pathology results of the patients.

Eligibility criteria:
inclusion criteria: * patients aged 18 years old or more * histologically proven invasive breast cancer * any t stage, any n stage with no distant metastasis m0 as evident by clinical examination and sonomammography. * eastern cooperative oncology group (ecog) performance status (ps) of ≤ 2. * patients with her-2 positive luminal b subtype, her-2 enriched or triple negative breast cancer. * patients who completed their systemic neoadjuvant therapy. exclusion criteria: * second malignancy * patients with early breast cancer clinicallyt1 (≤ 2 cm) n0 * metastatic patients m1 * patients with autoimmune diseases (type i diabetes mellitus, systemic lupus erythematosus, rheumatoid arthritis, sjogren's syndrome and behcet disease) * patients on systemic steroids or other immunomodulators (as methotrexate, tacrolimus and cyclosporine) * patients who started but didn't complete neoadjuvant systemic therapy * patients who didn't undergo surgery after neoadjuvant systemic therapy

Keywords: breast cancer her-2 positive triple negative neoadjuvant therapy
assessment of gait parameters and their impact on postoperative recovery in patients with lumbar spinal stenosis

Conditions: Lumbar Spinal Stenosis

Summary: the objective is to observe the evolution of walking parameters during the surgery process and find which of all calculated walking parameters represent the best indicators of functional disabilities and postoperative recovery for patient with lumbar spinal stenosis.


Eligibility criteria:
inclusion criteria: * patients with lumbar spinal stenosis * presenting neurogenic claudication * waiting for a surgery (laminectomy, laminotomy, fusion) exclusion criteria: * symptomatic hip or knee osteoarthritis

Keywords: neurogenic claudication gait parameters walking impairment
specific training after stoma surgery

Conditions: Colon Cancer

Summary: in sweden, approximately 43,000 people have undergone surgery with ileo-, colo- or urostomy. the most common type of stomy is a sigmoidostomy. a large proportion, about 50%, of patients who receive a permanent sigmoidostomy develop a parastomal hernia which may have major impact. there are indications that specific abdominal exercise may reduce the risk of parastomal hernias, but randomized studies are lacking. the aims of the study are: 1. to evaluate the effect of specific exercise to counteract the development of parastomal hernia in sigmoidostomy and the hernia's impact on ostomy function, physical function and quality of life. 2. to examine patients' experience of living with parastomal hernia. the study plans to include 240 patients who on will undergo surgery and receive a sigmoidostomy. these will be randomized to receive only advice according to the usual routine to avoid the development of parastomal hernia or these advice with the addition of specific abdominal muscle training. the training is initiated before the operation and is then carried out during the first postoperative year. follow-up will be done with a clinical assessment and with measurement of bulge and size of the parastomal hernia manually, with electronic measuring equipment and via computed tomography images. patients will assess their stoma and stoma function and assess any discomfort and its consequences of hernia via a study-specific questionnaire. type of ostomy bandage will also be registered. the evaluation will be carried out 6, 12 and 36 months postoperatively. prior to the start of sub-study a, the planned measurement methods to assess whether a parastomal hernia is present will be tested for validity. in addition, a group of patients (≥15 people) with parastomal hernia will be included in a qualitative sub-study where they will be interviewed about their experiences of the hernia hernia and how it may affect daily life. the present study will be able to answer whether specific exercise can reduce the risk of parastomal hernia. methods for clinically assessing and evaluating bulging and hernias will be tested and evaluated in relation to patient-reported symptoms. in addition, the study will provide information about the patient's experience of having a parastomal hernia and how it affects daily life and physical activity. the results will provide an increased understanding of parastomal hernias, which may change the follow-up of patients in the future.


Eligibility criteria:
inclusion criteria: - a consecutive series of patients who are scheduled to have a permanent sigmoidostomy exclusion criteria: * not swedish speaking * impaired cognitive ability * physical disability that limits the possibility of carrying out the intervention. * lung disease including chronic cough. * previous hernia in the abdominal wall. * previous open abdominal surgery with scars ≥20 cm * spread malignant disease at inclusion * acute surgery

Keywords: hernia abdominal muscles stabilizing training
comparison of radiation exposure to patients during endoscopic retrograde cholangiopancreatography (ercp) performed by endoscopists trained in judicious use of fluoroscopy with those without formal training

Conditions: Pancreatic Cancer

Summary: purpose: to compare the radiation exposure in patients during endoscopic retrograde cholangiopancreatography (ercp) done by endoscopists formally trained in judicious use of fluoroscopy versus ercps done by endoscopists without such formal training. research design: this is an observational study to compare radiation exposure in patients during ercps based on formal training. procedures to be used: none risks and potential benefits there are no risks associated with this study as it is a retrospective chart review. potential benefits include the knowledge gained from this study which may be of help to patients in the future. importance of knowledge that may reasonably be expected to result the knowledge gained from this study may be of help to provide new insights and develop newer guidelines for radiation use in the future.


Eligibility criteria:
inclusion criteria: * any indications for undergoing an ercp. if a patient undergoes more than one ercp then it shall be reported as such, as multiple data points. * only those ercp cases will be included that have been exposed to fluoroscopy (x-ray radiation). * adult populations will be included, all races and belonging to any gender will be included in the study. exclusion criteria: * patients who didn't receive ercp * those in whom the biliary or pancreatic ducts are not cannulated and therefore who do not receive any fluoroscopy * pregnant women * patient population less than 18 years of age
the effect of rectus muscle approximation at cesarean delivery on pain perceived after operation

Conditions: Pain, Postoperative

Summary: this is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at cesarean delivery.

this is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at cesarean delivery. postoperative pain will be assessed in 2 groups. rectus muscle approximation will be done to the first group. the second group will be the control group.

Eligibility criteria:
inclusion criteria: * women who will undergo first elective cesarean section * singleton pregnancy exclusion criteria: * previous abdominal or pelvic surgery * medical or psychiatric disease * previous pelvic inflammatory disease * obesity * allergy to analgesics