Kornimate/medical-research-clean huggingface dataset:
pilot study on botulinum toxin b as treatment for hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: randomized double blind placebo controlled pilot study/proof of concept-study to see if intradermal injection with botulinum toxin b is an effective treatment of hidradenitis suppurativa

twenty patients with hidradenitis suppurativa will be enrolled and randomised to treatment with either botulinum toxin b or placebo (saline) in affected areas. intervention and recording of data will be performed every three months. after three months, all patients will receive active substance. after six months, randomization will revealed. patients with clinical improvement will be given the opportunity to continue treatment for additional six months.

Eligibility criteria:
inclusion criteria: * patients with active hidradenitis in the stage i-iii according to hurleys classification. patients are referred to a dermatology out-patient clinic or patients already in an established treatment program, where there is indication for new or different treatment, or surgical intervention. patients must have typical affection of the disease of either axillae, groins, and/or perigenital/perianal area exclusion criteria: * patients in need of emergency medical or surgical treatment of hidradenitis will be excluded until the disease is in a quiet, controlled phase. pregnant or lactating, as well as patients with neurological disease such as myasthenia gravis or motor neuron disease.

Keywords: botulinum toxin
cost-effectiveness of routine follow-up visits in patients with a pacemaker: the followpace study

Conditions: Arrhythmia; Heart Diseases

Summary: the overall objective of the study is to quantify the true prognostic value and cost-effectiveness of routine follow-up visits in patients who receive an approved pacemaker of any type for the first time.

specific objectives : * to determine the incidence of complications occurring in the first year after implantation of a pacemaker. * to determine the quality of life at one year after pacemaker implantation in comparison with the quality of life before implantation. * to determine which baseline (patient and pacemaker related) characteristics measured during implantation are prognostic predictors for the occurrence of complications and quality of life after one year. * to determine which characteristics measured during follow-up visits truly have added predictive value, and to what extent. * to determine to what extent responsibilities for pacemaker check-up can be safely delegated to non-cardiologists (e.g. pacemaker technicians or manufacturers' delegates).

Eligibility criteria:
inclusion criteria: * each patient aged 18 years or over receiving a pacemaker for the first time in one of the participating dutch pacemaker implanting centers, is a potential candidate for the study. exclusion criteria: * patients are not eligible if they refuse to sign informed consent on use of personal medical data. * patients who are taking any investigational (new) drug or have a non-approved or investigational pacemaker system which requires unusual follow-up regarding the pacemaker * patients having diseases that are likely to cause death or significant morbidity during the study period such as neoplasia and immune, infectious or degenerative diseases will be excluded.

Keywords: pacemaker routine follow-up complications quality of life
cervical vestibular evoked myogenic potentials in recurrent and persistant benign paroxysmal positional vertigo

Conditions: Benign Paroxysmal Positional Vertigo

Summary: the goal of this observational study is to compare the cervical vestibular evoked myogenic potentials in recurrent/persistant bppv and nonrecurrent bppv. recurrent/persistant bppv is considered as the patients who require more than one repositioning manuever for the resolution of symptoms and the recurrent cases in the first three months after the diagnosis. the main question\[s\] it aims to answer are: * is there any difference between the cvemp findings of diseased ears of recurrent and nonrecurrent bppv cases? * is there any difference between the cvemp findings of diseased ears and healthy ears of bppv patients * is there any difference between the cvemp findings of healthy ears of recurrent and nonrecurrent bppv cases and healthy controls? patients with vng confirmed bppv will be recruited and cvemp test will be performed before the therapeutic manuevers. control visits will be scheduled on the 7th day after the therateutic menuevers are performed. patients will be followed-up for 4 weeks after the resolution of symptoms. researchers will compare recurrent (group 1), nonrecurrent (group 2) bppv patients and healthy controls (group 3) to see if there is any difference between the cvemp findings of two groups.


Eligibility criteria:
inclusion criteria: - patients admitted to ent clinic with unilateral posterior or lateral canal bppv for the first time exclusion criteria: * patients with bilateral bppv * patients with recurrent or resistant bppv * patients with spontaneous nystagmus * vestibular or neurologic disorders other than bppv * patients who use medication which may affect the vestibular system or muscle tone * cervical muscle disorders and ocular pathologies which may affect the vemp results

Keywords: benign paroxysmal positional vertigo cervical vestibular evoked myogenic potentials vestibular function tests saccule and utricle
study of thymosin beta 4 in patients with pressure ulcers

Conditions: Pressure Ulcers

Summary: the purpose of this study is to evaluate the safety, tolerability and effectiveness of thymosin beta 4 administered topically in patients with pressure ulcers

the purpose of this double-blind, placebo-controlled, dose-escalation study is to evaluate the safety, tolerability and effectiveness of thymosin beta 4 (tβ4), administered topically, in patients with pressure ulcers (pu). pu is caused by prolonged pressure or rubbing of the body in areas prone to moisture and friction. pu affects primarily elderly, bedridden patients. tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.

Eligibility criteria:
inclusion criteria: * informed consent form signed by the patient or patient's legal representative * inpatients and outpatients * at least 1 pu with full-thickness skin loss and no joint capsule or bone exposure * surface area between 5 and 70 cm2 * ulcer present and stable for at least 1 month before enrollment exclusion criteria: * use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment * use of immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment. systemic steroids not allowed 30 days prior to enrollment. topical therapy other than steroidal is allowed up to 7 days prior to enrollment * history of adverse events to any ingredients of study medication * neurological, cardiovascular, respiratory, hepatic, renal, or metabolic disease likely to interfere with the patient's participation in or completion of the study * arterial or venous disorder resulting in ulcerated wounds * diabetes mellitus except if disease is determined to be under control with a glycosylated hemoglobin ≤8.5% of total hemoglobin * pregnancy or breastfeeding during the study. (a serum pregnancy test will be performed at screening for female patients of childbearing potential.)

Keywords: pressure ulcers cutaneous wound- healing chronic wound-healing thymosin beta 4 laminin-5
fiber tolerability in children

Conditions: Signs and Symptoms, Digestive

Summary: assessment of the digestive tolerability of the promitor® .

the trial will be multicenter, double-blind, placebo-controlled, randomized with a 4-arm parallel-design. the subjects wil be randomized to one of the four arms, i.e. four doses of investigational product balanced in maltodextrin, given at the doses of 6, 9 or 12 g (corresponding to 4, 6, or 8 g of fibers) twice a day with the meals of the morning and of the evening versus control (maltodextrin, no fibers) over one week of intake. the total sample size is 40 healthy children from 8 to 12 years old, male and female.

Eligibility criteria:
inclusion criteria: * healthy children, * aged between 8 and 12 years old included * acceptance of the taste of the product * having breakfast on daily basis * consent and/or assent received according to regulation * informed consent of one of the parents/guardians (for the study to be conducted in switzerland, in respect with the swiss regulation) or informed consent of both parents/guardians (for the study to be conducted in france, in respect with the french regulation) * parents/guardians affiliated to a health insurance (only for the study to be conducted in france, in respect with the french regulation) exclusion criteria: * specific food regimen * intolerability or food allergy * antibiotic or any medication impacting the gut transit during the 2 weeks before the study * chronic gastrointestinal disease * gastroenteritis in the 2 weeks preceding the study * constipation or diarrhea based on romeiii criteria (in average: more than 3 stools per day or less than 3 stools per week) * children and parents expected not to understand and perform the trial correctly (i.e.: troubles in learning and/or speaking) * child in a situation which, in the opinion of the principal investigator, could interfere with the optimal participation to the study or constitute a particular risk of non-compliance * having participated in another clinical trial for 1 month, or currently participating in a clinical trial * under legal protection or deprived from his rights following administrative or judicial decision (only for the study to be conducted in france, in respect with the french regulation)

Keywords: fiber tolerability children
a research study of how oral semaglutide tablets work in healthy people who are chinese

Conditions: Healthy Volunteers; Diabetes Mellitus, Type 2

Summary: this study looks at the way a new medicine tablet called semaglutide moves in and throughout the body over time. it will also look at if the medicine is safe and the body can accept it. the new medicine is planned to treat diabetes. the aim of the study is to see how semaglutide tablets work in healthy people who are chinese. participants will either get oral semaglutide tablets or placebo (dummy) tablets - which treatment is decided by chance. the tablet form of semaglutide is a new medicine that cannot be prescribed. doctors can prescribe semaglutide as an injection only. it is for the treatment of diabetes in some countries. participants will get 1 tablet per day for 12 weeks (84 days). participants will get 1 tablet a day to take with up to half a glass of water (maximum 120 ml). participants must take the tablet first thing in the morning on an empty stomach (water is allowed until 2 hours before taking the tablet). after taking the tablet, participants must not eat or drink anything for at least 30 minutes. after 30 minutes, they can have their first meal of the day and take any other medicines they may need, such as birth control tablets, routine vitamins and use of paracetamol at times.


Eligibility criteria:
inclusion criteria: * chinese male or female, aged 18-55 years (both inclusive) at the time of signing informed consent. * body weight equal to or above 54.0 kg * body mass index (bmi) between 20.0 and 24.9 kg/m\^2 (both inclusive) * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ecg and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods * history of pancreatitis (acute or chronic) as declared by the subject. * family or personal history of multiple endocrine neoplasia type 2 (men2) or medullary thyroid carcinoma (mtc) as declared by the subject. * history or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) as declared by the subject. * history of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) as declared by the subject. * smoker (defined as a subject who is smoking equal to or more than 1 cigarette or the equivalent per day). * unable or unwilling to refrain from smoking and use of nicotine substitute products during the inpatient periods, as judged by the investigator. * any blood draw in excess of 25 ml in the past month, or donation of blood or plasma in excess of 400 ml within the 3 months preceding screening.
robotic trans-abdominal retromuscular umbilical prosthesis (r-tarup)

Conditions: Ventral Hernia

Summary: combining the advantage of minimally invasive surgery with laparoscopy to reduce postoperative complications and the placement of a retromuscular prosthesis with closure of the defect in order to reduce the risk of adhesion and restore normal anatomy in the treatment of primary and incisional ventral hernias, is made possible through robotic assistance. the challenge of this study concerns the evaluation of quality of life, postoperative pain and recurrence at 6 months in the management of primary and incisional ventral hernias by robot-assisted laparoscopic approach.

the robotic-assisted laparoscopic approach for the treatment of primary and secondary ventral hernias is already used in the visceral department of nancy in france. this technique seems to reduce post operative pain, to improve quality of live and to reduce recurrence. the goal of the study is to evaluate the benefices of this technique. the quality of life, postoperative pain and recurrence will be evaluated at one and six months postoperatively. the recurrence will be evaluated by clinical examination and a computed tomography scan performed at sixth month postoperatively.

Eligibility criteria:
inclusion criteria: * major patients undergoing a robotic-assisted laparoscopy procedure for the treatment of ventral hernia repair exclusion criteria: * patient minor

Keywords: robotic assisted laparoscopy
effectiveness of long-term versus short-term treatment of generalized anxiety disorder with venlafaxine xr

Conditions: Anxiety Disorders

Summary: this study will assess the effectiveness of venlafaxine xr, randomized to either venlafaxine xr or placebo in preventing the relapse of generalized anxiety disorder after 6 months of treatment versus 12 months of treatment.

generalized anxiety disorder (gad) is a highly prevalent, chronic psychiatric disorder. despite the fact that gad frequently demands prolonged treatment with medication, very little is known about the benefits of long-term treatment. gad is characterized by 6 months or more of exaggerated worry and tension that is unfounded or much more severe than the normal anxiety most people experience. people with gad are unable to relax and often suffer from insomnia. venlafaxine xr, a drug used to treat depression, has been shown to be effective in the short-term treatment of gad. however, its benefits over a course of more than 8 weeks have not been assessed. this study will evaluate the effectiveness of venlafaxine xr in treating gad on a long-term basis and preventing the relapse of gad after 6 months of treatment versus 12 months of treatment. participants in this double-blind study will first receive 6 months of open-label treatment with venlafaxine xr. upon completion of this initial phase, participants will be randomly assigned to either continue on venlafaxine xr or begin taking placebo. after 12 months, participants taking venlafaxine xr will be randomly assigned to continue on the drug or switch to placebo. participants will have 22 study visits over at least 18 months. follow-up visits will occur 24 months after enrollment. relapse of gad will be assessed with the hamilton anxiety scale and global severity and improvement scale. a variety of methods, including questionnaires and standardized scales, will be used to assess secondary outcomes.

Eligibility criteria:
inclusion criteria: * gad diagnosis by structured interview * hamilton anxiety scale score of 18 or more * clinical global impressions severity scale score of at least 4 * hamilton depression scale score of 18 or less * hamilton depression scale suicide item score less than 2 * use of an effective form of contraception throughout the study exclusion criteria: * hypersensitivity to venlafaxine xr * history of seizures * episode of major depressive disorder in the previous 6 months * history of any psychotic illness, bipolar disorder, or dementia * substance abuse and dependence during the past 6 months * other anxiety disorders with the exception of social phobia as long as gad is primary * regular use of anxiolytics or antidepressants within 7 days of study onset * use of fluoxetine or monoamine oxidase inhibitors within 28 days of study onset (low dose usage of benzodiazepines will not prevent participation) * use of other psychotropic medication besides benzodiazepines during the study

Keywords: generalized anxiety disorder chronic mediation treatment double-blind placebo controlled venlafaxine xr relapse
celecoxib in postoperative analgesia for radius fracture surgery

Conditions: Pain, Postoperative

Summary: patients scheduled for elective osteosynthesis of the distal radius will be randomized to receive celecoxib 100 mg orally (po) at 6 in the morning before surgery and every 12 hours for 2 days thereafter, or a placebo pill in the same regimen. after surgery under general anaesthesia, they will receive paracetamol 1 g intravenously (iv) every 6 hours and if pain intensity is greater than 4 on a numeric rating scale (nrs) of 0-10, piritramid 15 mg intramuscularly (im) will be administered. pain intensity, piritramid consumption and side effects of treatment will be recorded in a questionnaire for 2 days.

a prospective single-blinded randomized study will be performed in patients of the orthopaedic clinic of the 3rd medical faculty of charles university (3lf uk) and the faculty hospital kralovske vinohrady (fhkv) scheduled for elective osteosynthesis of the distal radius. the expected number of participants is 25 in each arm of the study. they will be randomized by envelope method into an non-steroidal analgesic (nsa) group, which will receive celecoxib at 6 in the morning before surgery, and a c group, which will receive a placebo pill prepared by the hospital pharmacy. general anesthesia will be performed in both groups in the standard way using propofol, sufentanil and sevoflurane 1 minimal alveolar concentration (mac) with air and oxygen at 40% concentration. at the end of surgery, each patient will be given paracetamol 1 g intravenously (iv) and ondansetron 4 mg iv. pain intensity after surgery will be measured on a numerical rating scale (nrs) 0-10. for postoperative analgesia, both groups will receive paracetamol 1 g iv. every 6 hours, and for nrs\>4 pain intensity, piritramid 15 mg intramuscularly (im). the nsa group will receive celecoxib 100 mg orally (po) at 6 in the morning and 6 in the afternoon, and group c will receive placebo at the same interval. parameters to be monitored will be postoperative pain intensity for the primary objective, and opioid piritramid consumption and side effects of the treatment for the secondary objectives. nrs, number of doses of piritramid and side effects will be recorded in a coded questionnaire.

Eligibility criteria:
inclusion criteria: * patients scheduled for osteosynthesis of distal radius fracture exclusion criteria: * known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib * history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. * patients who have demonstrated allergic-type reactions to sulfonamides. * inability to understand the questionnaire

Keywords: postoperative pain distal radius fracture osteosynthesis celecoxib
video training supplementation for patients discharged on home parental nutrition

Conditions: Intestinal Failure

Summary: the goal of this clinical trial is to develop an educational video addressing the aseptic techniques to safely handle central catheters for administrating parenteral nutrition at home.

home parenteral nutrition is an alternative form of providing nutrition to people whose digestive systems either can't absorb or tolerate food eaten by mouth. parenteral nutrition provides liquid nutrients, including carbohydrates, proteins, fats, vitamins, minerals and electrolytes. in recent years, more emphasis has been placed on delivering parenteral nutrition to patients at home. studies have shown that patients receiving home parenteral nutrition are at higher risk for bloodstream infections compared to other patients with chronic infusion needs. catheter-related bloodstream infection is a major cause of mortality and morbidity in patients receiving parenteral nutrition. it is important to maintain safe vascular access to prevent life-threatening complications. this study aims to assess the effectiveness of the video training on the rate of catheter related bloodstream infection over a 12-month period of time.

Eligibility criteria:
inclusion criteria: * taking home parenteral nutrition for the first time * willing to self-administer parenteral nutrition * age ≥ 18 yrs * able to provide informed consent * able speak and understand english exclusion criteria: * already taking home parenteral nutrition * not willing to self-administer parenteral nutrition * age \< 18 years-old * unable to provide informed consent * non-english speakers
men's beliefs about associations between hpv, cancers, and hpv vaccination

Conditions: Anus Neoplasms

Summary: this research focuses on men who have sex with men (msm) who are at higher risk of anal cancer. the survey will evaluate their beliefs about anal and oral cancer, their knowledge about role of human papillomavirus (hpv) infection in these cancers, and their knowledge of hpv vaccination and anal pap smears. approximately 12% of subjects will be hiv-positive.

little research has examined men's understanding of what causes anal and oral cancers and whether hpv vaccination can play a potential protective role. this research focuses on men who have sex with men (msm) who are at notably elevated risk of anal cancer, and seeks to characterize their beliefs about anal and oral cancer, knowledge about the etiological role of hpv infection in these cancers, as well as their knowledge of hpv vaccination and anal pap smears. we will also study heterosexual men.

Eligibility criteria:
inclusion criteria: * male * aged 18-59 * answered question about sexual orientation exclusion criteria: * none