Kornimate/medical-research-clean huggingface dataset:
prospective evaluation of intrathecal targeted drug delivery for cancer associated pain

Conditions: Cancer Pain; Chronic Pain; Cancer Associated Pain; Neuropathic Pain

Summary: this registry study will prospectively evaluate the differences in treatment outcomes in terms of pain intensity, pain interference, concomitant medication use, health-related quality of life, opioid adverse effects, and healthcare utilization between targeted drug delivery and conservative medication management only groups.

this is a prospective, open-label, short term patient registry where up to 169 subjects with cancer associated pain will be enrolled. subjects with cancer associated pain who are receiving conservative medical management (cmm) only and cancer patients receiving intrathecal drug delivery system (idds) along with cmm will be followed for up to 3 months. subjects will be evaluated monthly up to 3 months from the medical care initiation which is the implant day for the idds group and start of the new treatment plan for the cmm group. subjects that decide to cross-over to the idds group in a future date, will still be followed for their progress. based on routine care, subjects will be seen at day of implant, 1 month post-implant, 2 months post-implant, and 3- and 6- months post-implant.

Eligibility criteria:
inclusion criteria: * age of 21 and older * uncontrolled cancer-associated pain (pain score of \>5 on nrs) despite oral use of 60 mg/d morphine equivalent a week prior to screening * adverse side effects from long term opioid use defined as limiting or severely affecting patient's day to day function * life expectancy of \> 3 months exclusion criteria: * active infections * controlled pain without adverse side effects that are limiting day to day function * mechanical barriers * obstruction of cerebrospinal fluid (csf)

Keywords: targeted drug delivery cancer pain conservative pain management neuromodulation opioid healthcare-utilization quality of life
comparing pain after laparoscopic hernia repair using two different types of mesh fixation

Conditions: Inguinal Hernia; Pain

Summary: a clinical study evaluating acute and chronic pain following laparoscopic inguinal hernia repair comparing the progriptm self- fixating mesh with tack fixation.

the primary aim of this study is to evaluate acute and chronic pain following laparoscopic inguinal hernia repair comparing the progriptm self- fixating mesh with tack fixation. the progriptm laparoscopic self-fixating mesh has been approved for implantation to reinforce the abdominal wall during laparoscopic inguinal hernia repair (tapp). the mesh delivers tack free fixation above and below the inguinal ligament potentially eliminating pain associated with traditional tack fixation. the present study is a prospective randomized clinical trial designed to collect information about complications such as acute and chronic pain and hernia recurrence rate from patients referred for laparoscopic inguinal hernia repair. patients who qualify to take part in the study will be randomized for a procedure using either a self-gripping progrip mesh or a conventional polypropylene mesh attached with absorbatacktm. data will be collected from operations performed at 6 high volume hernia centers in denmark. patients eligible for study will be recruited from the referral list for inguinal hernia repair at each participating institution. prior to scheduled surgery, patients will be consented and will complete a questionnaire on inguinal pain intensity and quality of life . the mesh will be placed intraperitoneally after the component separation is complete. the peritoneal layer will be closed with a v-loc stitch in both groups. after surgery, key clinical data will be recorded, such as type of mesh used, size of the hernia defect, number of tacks used etc. the participating patients will receive postoperative questionnaires following the first year after surgery.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective, inguinal hernia repair * 18 years or older * male gender * asa physical classification system 1-3 * informed consent exclusion criteria: * patients with recurrent hernia, except patients operated in childhood without mesh application. * patients with bilateral hernia * patients with chronic pain * patients in anticoagulation therapy * previous major surgery in lower abdomen

Keywords: inguinal hernia repair hernia progrib self-fixating mesh biological mesh tack fixation
comparison of varenicline and placebo for smoking cessation in schizophrenia

Conditions: Cigarette Smoking; Schizophrenia

Summary: the purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. specifically, the primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. we hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.

the primary objective of the data analysis will be to measure the rate of smoking cessation in the two treatment groups. smoking cessation will be measured weekly through a composite measure of self-reported abstinence, end expired carbon monoxide (co) of less than c10 ppm and urine cotinine dipstick measure of \< 30 ng/ml. the primary endpoint will be point prevalence at 12 weeks. the four week continuous abstinence rate for the last four weeks of the treatment phase will also be evaluated. the point prevalence abstinence rates will also be obtained. the secondary objective is to determine whether smoking cessation is associated with a worsening of cognition and psychiatric symptomology. we hypothesize that subjects who achieve abstinence in the varenicline group will not show worsening on neurocognitive and symptom measures compared to abstinence subjects in the placebo group. lastly, we will attempt to identify any clinical or topographic markers which predict cessation.

Eligibility criteria:
inclusion criteria: * age 18-64 * regular ten cigarette per day smoker for one year * nicotine dependency score greater than or equal to four * dsm-iv diagnosis of schizophrenia or schizoaffective disorder * psychiatric medication regimen unchanged for at least 90 days * psychiatric medication dosage unchanged for at least 30 days exclusion criteria: * psychiatric hospitalization in last 6 months * meets criteria for current major depressive disorder or has a score of greater than 10 on the calgary depression scale (see withdrawal criteria) * suicide or homicide ideation with a plan in the last six months * life time history of suicide attempt * has had a diagnosis of schizophrenia or schizoaffective disorder for less than three years * current treatment with bupropion sr * dsm-iv diagnosis of alcohol or substance dependence within last 6 months\* * dsm-iv diagnosis of alcohol or substance abuse within three months \* * pregnancy or lactation in females (+hcg) * use of tobacco product other than cigarettes * use of nicotine replacements * unstable or serious medical condition in last 6 months * regular use of cimetidine (otc or rx) \*substance abuse/dependency exclusions do not apply to abuse of or dependence on nicotine.
multicomponent exercise training in frail elderly

Conditions: Frailty; Exercise Addiction

Summary: the aim of the present study will be to assess the effectiveness of the multicomponent exercise training in frail for the physical function, frailty and performance. all the individuals will be assessed two times.

this will be a experimental, randomized controlled intervention study in frail. subjects will be recruited at the albertia care center, madrid. the exercise training group will developed a concurrent training 3 days per week during 6 weeks. the control group will follow an usual care also for 6 weeks. the main variables will be as follows: * ultrasound imaging measurements for the lower limb: core muscles, vastus medialis, rectus femoris, vastus intermedius, gastrocnemius, soleus. we will employed a general electric (ge) ultrasound device in b mode to assess the thickness of the muscles. * heart rate variability with a suunto smart bell. * activities of daily living with the bartel index. * force-velocity profile and muscle power. * frailty with the linda´s frailty criteria. the exercise program was applied for 6 weeks. a total of 18 sessions were distributed in 3 weekly sessions. the participants performed a resistance exercises: leg press at an intensity of 40%-60% with 10 repetitions, 12 repetitions of steps with their bodyweight and a plantar flexion followed by a cardiovascular high intensity interval training (hiit) exercise walking on a treadmill. one measurements will be taken (pre), the second (post) measurements will be performed at 6 weeks.

Eligibility criteria:
inclusion criteria: * men and women aged 75 years or more, * 2 or more points in the short physical performance battery (sppb) * capability of walking (alone or assisted) exclusion criteria: * severity cognitive alterations * severe disability on the barthel score * surgeries in the previous 6 months * other any disorder that exclude for the exercise group.

Keywords: frailty exercise aging
effect of noise isolation on the incidence of moderate to severe postoperative pain

Conditions: Postoperative Pain

Summary: to investigate the effect of noise isolation during general anesthesia on the incidence of moderate to severe postoperative pain in patients undergoing major abdominal surgery. the aim of this study was to determine whether noise isolation can reduce the incidence of moderate to severe postoperative pain and analgesic use.


Eligibility criteria:
inclusion criteria: * between the ages of 18 and 70, both male and female. * american society of anesthesiologists classification 1-3 * patients undergoing elective major abdominal surgery under general anesthesia(surgery time ≥ 2h) * voluntarily accept patient controlled intravenous analgesia and signed informed consent exclusion criteria: * patients with previous severe disease * patients with hearing abnormalities * patients requiring mechanical ventilation or undergoing epidural catheters or other types of regional anesthesia after surgery * patients with chronic preoperative pain and/or long-term analgesic use * patients who could not cooperate with the study for any reason

Keywords: noise isolation major abdominal surgery postoperative pain
identification of an atypical acetabular fracture with an independent roof component: incidence and description

Conditions: Acetabular Fracture

Summary: treatment of acetabular fractures needs a perfect diagnosis to anticipate surgical difficulties. e. letournel described a rare atypical both-column fracture which " introduces enormous surgical difficulties ". its particularity is a sagittal comminution interesting the acetabular roof. in this experience the particular fracture is probably under-diagnosed. the purpose of this study is to give the exact incidence and a precise description of these fractures to improve their surgical management.


Eligibility criteria:
inclusion criteria: * patient with acetabular fracture exclusion criteria: * other type of fracture
a postmarket clinical follow up study (pmcf) to evaluate the safety and performance of veriforte/granudacyn® med wound irrigation solution.

Conditions: Wounds

Summary: in the course of this clinical trial, it was shown that the use of granudacyn/veriforte med wound irrigation solution in the course of adjuvant therapy supports wound healing through mechanical irrigation and moistening of the wound. no risks have been reported. the benefits of using granudacyn/veriforte med wound irrigation solution therefore outweigh the potential risks.

aim of this clinical trial was to collect clinical data on the performance and safety of the use of granudacyn/veriforte med as a wound irrigation solution, for cleansing and irrigation of acute, chronic or contaminated wounds. the evaluation of the safety of the use of granudacyn/veriforte med wound irrigation solution within the scope of use was based on the frequency of adverse events (aes) and, in particular, treatment-emergent adverse events (ades). study design: * open-label, retrospective, monocentric, pmcf, non-interventional, observational study. * one treatment group (single arm): all subjects participating in the study will be treated with granudacyn/veriforte med wound irrigation solution. * the study will be conducted in austria. the participating trial centre is in lower austria: wpm ges.m.b.h

Eligibility criteria:
inclusion criteria: * presence of a documented case report within the indication, which enables a retrospective evaluation of the target variables. * subjects are ≥ 18 years of age. * gender: all. exclusion criteria: * vulnerable persons

Keywords: acute wounds, chronic wounds, burns
nefopam for post video-assisted thoracoscopic lobectomy

Conditions: Pain, Postoperative

Summary: video-assisted thoracoscopic (vats) lobectomy is mild to moderately pain procedure. for conventional thoracotomy, there are many invasive pain control such as epidural analgesia, paravertebral block. however, for vats, the invasive pain control somehow are too invasive. nefopam is non-opioid painkilling medication, serotonin, norepinephrine, dopamine reuptake inhibitor. many study were demonstrated positive outcome of nefopam usage in many operation such as abdominal surgery, laparocopic surgery, orthopedic surgery. nevertheless, nefopam for vats is not well studied yet.


Eligibility criteria:
inclusion criteria: * schedule to video-assisted thoracoscopic surgery : vats lobectomy * can operate a patient-controlled analgesia (pca) device * no contraindication for nefopam exclusion criteria: * epilepsy, on monoamine oxidase (mao) inhibitors, glaucoma * creatinine clearance \< 60 ml/min * liver disease: child-pugh score b or c * allergy to nefopam * chronic opioid use
physical performance and analgesic effects of tdcs in primary dysmenorrhea

Conditions: Transcranial Direct Current Stimulation; Dysmenorrhea Primary; Pain; Mental Disorders; Physical Fitness

Summary: technological advances and non-invasive techniques to modulate brain function have been developed, including transcranial direct current stimulation (tdcs). basically, electrodes are placed on the brain regions to stimulate or inhibit it. subsequently, a continuous electrical current (0.4-2 ma) is imposed, for a period of 3-20 minutes, to modify cortical excitability. few are the research groups that work on the topic of primary dysmenorrhea and the use of tdcs as the focus of study. preliminary studies associated the use of tdcs with pain reduction, but the outcomes of physical and behavioral function needs further investigation.


Eligibility criteria:
inclusion criteria: - to have primary dysmenorrhea symptoms for more than 6 months with a mean perception of at least 3 (on a scale of 0 to 10) on the visual analogue scale, to have a regular menstrual cycle from 28 to 32 days. exclusion criteria: - participants will be excluded if they have history of genitourinary disease (infectious oncology or infection), neurogenic bladder dysfunction, to have alcohol or drug abuse in the last 6 months, to have severe depression (score greater than 30 on the beck depression inventory), to have previously neurological disorders diagnosis and to be pregnant.
pmcf study of liquiband fix8® ohmf device

Conditions: Inguinal Hernia

Summary: study to evaluate the safety and performance of liquiband fix8® open hernia mesh fixation device.


Eligibility criteria:
inclusion criteria: * subject is able to understand and give informed consent to take part in the study * subject has a primary inguinal hernia. * subject is scheduled to undergo open inguinal hernia repair using the liquiband fix8® ohmf device. * subject is willing and able to comply with the protocol assessments at time of surgery and during the post-surgical follow-up period. exclusion criteria: * subject is undergoing open repair surgery for recurrent hernia, where the primary surgery was also open. subjects with recurrent hernia whose primary surgery was laparoscopic are not excluded. * subject has an anatomical defect or had prior surgical procedures that in the opinion of the investigator makes them unsuitable for open hernia repair with the liquiband fix8® ohmf device. * subject is known to be non-compliant with medical treatment. * subject is pregnant or actively breastfeeding. * subject has any significant or unstable medical or psychiatric condition that, in the opinion of the investigator, would interfere with his/her ability to participate in the study. * subject has a known sensitivity to cyanoacrylate or formaldehyde, d\&c violet no.2 dye or any other component of liquiband fix8® ohmf device. * the hernia mesh to be used in the repair is constructed from polytetrafluoroethylene (ptfe) or absorbable materials. * the hernia mesh to be used in the repair is a self-gripping mesh (e.g. progrip). * subject has active or potential infection at the surgical site. * subject has a history of keloid formation. * subject has a known vitamin c or zinc deficiency. * subject has a connective tissue disorder.

Keywords: inguinal hernia mesh fixation surgical site wound closure
a trial to assess a co-formulation of an insulin analog and pramlintide in subjects with type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: this trial is a monocentric, randomised, double-blind, active comparator, controlled, 3-period cross-over trial.

in this monocentric, randomised, double-blind, active comparator, controlled, cross-over trial, each patient will be randomly allocated to a sequence of three treatments: one single dose of the co-formulation of insulin analog and pramlintide (also called ado09), simultaneous separate injections of pramlintide and human insulin and one single dose of insulin lispro. to keep the blinding in this trial, a placebo injection will be given in addition to the ado09 formulation and insulin lispro dose for a total of 2 injections per dosing visit. during each visit, meal test procedures will be performed and subjects will stay at the clinical centre until post-dose follow-up period has been terminated. imp administration will be done subcutaneously immediately prior to test meal intake.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months * treated with multiple daily injection ≥ 12 months * treated with insulin glargine u100 or u300 or insulin detemir at screening * fasting c-peptide ≤ 0.30 nmol/l * bmi: 18.5-28.0 kg/m² (both inclusive) exclusion criteria: * known or suspected hypersensitivity to imps, paracetamol or related products * type 2 diabetes mellitus * clinically significant abnormal haematology, biochemistry or urinalysis screening test, as judged by the investigator considering the underlying disease * presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the investigator * known slowing of gastric emptying, including gastroparesis and or gastrointestinal surgery that in the opinion of the investigator, might change gastrointestinal motility and food absorption * intake of medication known to affect gastrointestinal motility, including but not limited to erythromycin, metoclopramide, cisapride, cholestyramine or colestipol within 4 weeks before screening
non exudative amd imaged with ss-oct- extension

Conditions: Dry Macular Degeneration

Summary: the investigators wish to better understand the role of the choriocapillaris (cc) in the formation and progression of non-exudative in age related macular degeneration (armd) by imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by studying their inter-dependence to determine if the loss of the cc could prove useful as an anatomic clinical trial endpoint in future drug trials.

the investigators wish to better understand the role of the choriocapillaris (cc) in the formation and progression of non-exudative in age related macular degeneration (armd) by imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by studying their inter-dependence to determine if the loss of the cc could prove useful as an anatomic clinical trial endpoint in future drug trials. this is an extension of a currently ongoing longitudinal observational study (birc-01) (nct03688243).

Eligibility criteria:
inclusion criteria: * enrollment in and completion of the birc-01 study * clinic diagnosis of non-exudative iamd in at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02 mm3 in the absence of ga or nga as diagnosed with oct en face imaging or clinical diagnosis of early or early/intermediate stage amd in one eye in the absence of nga or ga and exudative amd in the other eye or clinical diagnosis of ga or nga secondary to amd that is at least the size of a large druse (125 microns in diameter; 0.05 mm2) and no greater than 7 disc areas (17 mm2) in at least one eye which has never been treated with anti-vegf agents * willing and able to comply with clinic visits and study-related procedures * provide signed informed consent exclusion criteria: * subjects with exudative amd in both eyes * eyes with evidence of non-proliferative and proliferative diabetic retinopathy. * presence of confounding ocular diagnosis such as myopia \>6d, or other ocular conditions that may cause retinal pigment epithelium atrophy or exudative mnv * subjects currently or previously enrolled in other interventional clinical trials in which treatment was administered to the study eye. * previous vitrectomy or intravitreal injections in the study eye. * axial length measurement ≥ 26 mm. * subjects unable to give informed consent. * subjects who are unable to comply with imaging guidelines

Keywords: amd early amd intermediate amd geographic atrophy nascent ga
efficacy and safety of sotagliflozin in young adult patients with type 1 diabetes mellitus and elevated hemoglobin a1c

Conditions: Type 1 Diabetes Mellitus

Summary: this phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on hemoglobin a1c (a1c) reduction at week 12 in young adult participants with type 1 diabetes mellitus (t1dm) who have poor glycemic control on their current insulin regimen.


Eligibility criteria:
inclusion criteria: * participant had given written informed consent. * young adult participants \>=18 to \<=30 years old at screening, with a confirmed diagnosis of t1dm made at least 1 year prior to informed consent. * participants were being treated with insulin or insulin analogue delivered via continuous subcutaneous insulin infusion (csii) or multiple daily injections (mdi). * at screening, must had a1c \>= 9.0%. * must be willing and able to perform self-monitored blood glucose (smbg) and complete the study diary. * females of childbearing potential must use an adequate method of contraception and had a negative pregnancy test. exclusion criteria: * any prior use of lx4211/sotagliflozin. * use of antidiabetic agent other than insulin or insulin analogue at the time of screening. * use of sodium-glucose cotransporter (sglt) inhibitors within 8 weeks prior to start of the placebo run-in period. * chronic systemic corticosteroid use. * type 2 diabetes, or severely uncontrolled diabetes mellitus as determined by the investigator. * history of diabetic ketoacidosis (dka) or nonketotic hyperosmolar state within 6 months prior to the screening visit. * history of severe hypoglycemic event within 1 month prior to the screening visit.