Kornimate/medical-research-clean huggingface dataset:
improving quality of life in men and women with overweight or obesity

Conditions: Obesity; Overweight and Obesity; Quality of Life; Health Behavior

Summary: the purpose of this study is to evaluate the effect of the noom healthy weight program, a digital behavior change weight loss intervention, on quality of life as measured both by self-report and objective measures, compared to a waitlist control condition.


Eligibility criteria:
inclusion criteria: * able to understand and provide informed consent * 18-65 years old * self-report of good health (physical and mental) * not diagnosed with diabetes * overweight or obesity (bmi ≥ 25) * able to meet our criteria of adherence to the program (at least 1 engagement per week on one of the following: logged exercise, logged meals, steps, weigh-ins, coach messages, read articles, and days with at least one weigh-in.) * for females * not within the 6 months postpartum time frame * not planning to become pregnant in the next 5 months. exclusion criteria: * inability or unwillingness of a participant to give written informed consent * currently taking medication which affects sleep or heart rate (e.g., (i) central nervous system stimulants, (ii) respiratory medications, (iii) antihistamines, (iv) central acting hormones (e.g. corticosteroids, thyroid), (v) high-dose anticholinergics, (vi) and cannot be using the maximum recommended dose for antihypertensive medications or use of multiple antihypertensive medications) * current diagnosed mental health condition (except mild anxious or depressive symptoms) * current diagnosed sleep disorder or condition not related to obesity (e.g., narcolepsy) * currently pregnant or ≤ 6 months postpartum * currently participating in shift work and/or have travelled between time zones in the last month * presence of a condition or abnormality that in the opinion of the investigator would compromise the quality of the data; e.g., evidence of an eating disorder, major chronic condition
opioid-free anesthesia and thoracoscopy surgery

Conditions: Opioid Free Anesthesia; Thoracic Surgery

Summary: evaluation of a service ofa (opioid-free anesthesia) protocol on post-operative pain of patients operated on by video-thoracoscopic carcinologic surgery by counting them to a group of patients receiving standard general anesthesia with opioid.

a service protocol based on opioid-free anesthesia in patients undergoing pulmonary carcinologic surgery under video-thoracoscopy will be evaluated. the investigative team want to recruit 100 patients prospectively. these patients will be randomly assigned on the day of surgery between ofa (opioid free anesthesia) and oba (opioid based anesthesia). anesthesia and analgesia of patients in the ofa group will be performed without morphine according to the validated local protocol. we will use level 1 and 2 analgesics (paracetamol, nsaids and nefopam) associated with an erector spine block and anesthesia under propofol, dexmedetomidine and ketamine ivse. patients in the oba group will have so-called "basic" anesthesia and analgesia with opioids according to usual practice. postoperative pain by collecting morphine consumption in the first 48 hours postoperatively between the two groups will be compared. chronic neuropathic postoperative pain will also be collected by a telephone questionnaire at 3 months postoperative.

Eligibility criteria:
inclusion criteria: * adult patient * patient operated on pulmonary carcinologic surgery by thoracoscopy of a foreseeable duration greater than 2 hours exclusion criteria: * patient with unstable unstable unstable coronary artery disease, * patient contraindicated for the use of dexmedetomidine: heart rate\<50 / min, high degree atrioventricular block (2 and 3) unless fitted (carrier of a pacemaker), * patient on beta-blocker, allergy to dexdor®, * patient allergic to other drugs used in ofa (paracetamol and nsaids). * renal insufficiency patient with creatinine clearance\<30ml/min will not be excluded but will not receive nsaids. * minor patient, * adult patient under guardianship or curators.

Keywords: video-thoracoscopy chronic pain opioid free anesthesia thoracic surgery
moto post-marketing surveillance study

Conditions: Osteonecrosis; Osteo Arthritis Knee

Summary: the prospective, multicentric, observational study has the aims to monitor the performance of the moto medial unicompartmental knee system in the treatment of patients with knee disease requiring a uka. 150 patients will be recruited in 18 months and will be reviewed until 5 years follow-up visit after surgery. the primary objective of the study is to evaluate the prosthesis survival at 5 years.


Eligibility criteria:
inclusion criteria: * patients with unicompartmental tibiofemoral osteoarthritis (oa) of the knee that meet the indications for use of medacta implant included in this study (on-label use); * patients suffering from unilateral osteoarthritis or osteonecrosis of a single knee compartment; * frontal deformity \< 10° (evaluated on weight-bearing long-axis x-rays); * flexion contracture \< 10°; * intact ligaments; * patients willing and able to provide written informed consent for participation in the study; * patient's age over 18 years old; * patient with bmi \< 40 kg/m2; * patients willing to comply with the pre and post-operative evaluation schedule. exclusion criteria: * patients with one or more medical conditions identified as a contraindication in the labelling on any medacta implants used in this study; * any patient who cannot or will not provide informed consent for participation in the study; * patients who need a revision surgery; * patients who had previously undergone high tibial osteotomy or anterior cruciate ligament (acl) reconstruction; * patients with bmi ≥ 40 kg/m2; * patients unable to understand and take action; * any case not described in the inclusion criteria.

Keywords: unicompartmental knee arthroplasty uka antomic femoral component anatomic tibial component
efficacy and safety of clife1 gel in benign anorectal surgery

Conditions: Fissure;Anal; Fistula;Rectal; Hemorrhoids

Summary: double-blinded multicenter randomized clinical trial to evaluate the efficacy and safety of clife2 (lidocaine, referred as treatment a) respect clife1 (lidocaine plus diclofenac, referred as treatment b) in benign anorectal surgery.

120 patients were randomly assigned to two groups (60 in each group). the study was conducted in two parallel groups, with 1:1 randomization stratified by type of surgery and centre. treatment with clife 1 and clife 2 was applied from day 1 to day 6 post-surgery

Eligibility criteria:
inclusion criteria: * patients undergoing benign anorectal surgery (out or inpatients), with the following diagnoses: anal fissure, fistula, hemorrhoids * use of subarachnoid anesthesia with lidocaine exclusion criteria: * allergy or hypersensitivity to lidocaine or other local anesthesics. * patients not accepting subarachnoid anesthesia * patients with general anesthesia * hypersensitivity or contraindication to acetylsalicylic acid. * history of gastrointestinal hemorrhage or perforation due to nonsteroidal anti-inflammatory drugs (nsaids) use * active or relapsing peptic ulcer/gastrointestinal hemorrhage * serious heart failure. * active crohn disease * active ulcerative colitis * moderate or sever renal failure * severe liver disfunction * coagulation disorders requiring treatment with anticoagulant drugs * proctitis (due to autoimmune disease, foreign substances, sucally transmitted diseases * treatment with: beta blockers, calcium channel blockers (verapamil and diltiazem), anti-arrhythmics (digoxin, amiodarone), ivabradine, lithium, steroids * pregnancy
study of npl-2003 in adolescents with obsessive compulsive disorder (ocd)

Conditions: Obsessive Compulsive Disorder

Summary: the purpose of this study is to investigate the effect of npl-2003 on the symptoms of obsessive compulsive disorder (ocd) in an adolescent population.


Eligibility criteria:
inclusion criteria: * meets dsm-iv criteria for obsessive compulsive disorder. * cy-bocs score of greater or equal to 16 at screening. * nimh global oc scale score of 7 or higher at screening. exclusion criteria: * patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment. * autistic disorder or pervasive developmental disorder. * moderate or severe mental retardation. * severe renal insufficiency. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: obsessive compulsive disorder neuropharm npl-2003
cardiovascular morbidity during treatment of overactive bladder with b3 agonists

Conditions: Overactive Bladder

Summary: overactive bladder syndrome complicates life for many women. 60-70% of women report improvement with treatment but the antikolinergic treatment is often limited by the adverse events, for example dry mouth, obstipation and urinary retention. mirabegron is a b3-adrenoreceptor agonist which induces detrusor relaxation. earlier studies has demonstrated similar efficacy comparing mirabegron with antimuscarinics but a significant reduction of adverse events. the aim of the present study is to survey cardiovascular adverse events with mirabegron treatment in a general population suffering from overactive bladder syndrome.

overactive bladder syndrome complicates life for many women. for 30 years the dominant treatment of overactive bladder syndrome has been antimuscarinics as first-line pharmacotherapy. 60-70% of women report improvement with treatment but the therapy is limited by the adverse events, for example dry mouth, obstipation and urin retention. in sweden, prescription of antimuscarinics has increased by 69% during the period of 2000-2007 which implies an increasing desire to seek treatment. mirabegron is a b3-adrenoreceptor agonist which induces detrusor relaxation. earlier studies have demonstrated similar efficacy when comparing mirabegron with antimuscarinics but a significant reduction of adverse events. clinical phase i-iii trials have registered an increased pulse rate and effects on blood pressure in some patients. the aim of the present study is to survey cardiovascular adverse events with treatment with mirabegron in the general population suffering from overactive bladder syndrome.

Eligibility criteria:
inclusion criteria * overactive bladder syndrome, eligible for mirabegron treatment exclusion criteria: * as specified by regulatory authorities for drug prescription
effects of complementary therapies delivered via mobile technologies

Conditions: Acute Pain; Anxiety; Self Efficacy

Summary: the purpose of this study is to determine the effects of complementary therapies delivered via mobile technologies have a therapeutic effect on surgical patients' anxiety, pain, and self-efficacy in healing reports before, following, and at 10-day follow-up.

patients scheduled for same-day surgery (sds) often experience state anxiety, which may result in increased perceptions of pain and lower self-efficacy in healing. complementary therapies (ct), such as relaxation technique, massage, guided imagery, and acupuncture have been shown to benefit patients undergoing surgery. the aim of this study was to examine the effects of audio relaxation technique (art), music intervention (mi), nature video application with music (nvam), and nature video application without music (nva) delivered via mobile technologies on patients' state anxiety, pain perception, and perceived self-efficacy in healing. methods a randomized controlled trial (rct) involving 105 sds patients, who were assigned to an art (n = 25), mi (n = 25), nvam (n = 15), nva (n = 16), or a control group (n = 24) were assessed for state anxiety via the state trait anxiety inventory (stai), self-reported pain using the numeric rating scale (nrs), and self-efficacy with the general self-efficacy scale (gse) four days prior to surgery, immediately prior and following the surgical intervention, and at day five post-operative.

Eligibility criteria:
inclusion criteria: * age range 18-75-years * english or icelandic speaking * cognitively alert and oriented to person, place, time, and situation * intact visual and auditory senses exclusion criteria: * history of substance abuse * chronic pain lasting more than six months * use of narcotic medication for more than six months * major psychiatric disorders * taking prescribed medications for thought disorders * having ophthalmology and/or auditory surgery or impairments

Keywords: complementary medicine state anxiety acute pain self-efficacy surgery medical music intervention nature therapy relaxation technique
carpal tunnel release via two small incisions comparing with via standard incision and under endoscope

Conditions: Carpal Tunnel Syndrome

Summary: carpal tunnel release via two small incisions comparing with via standard incision and under endoscope.

carpal tunnel syndrome (cts) affects over 60 million people worldwide. if a regimen of conservative management has failed, surgical release of the median nerve is warranted. numerous approaches for carpal tunnel release have been described that range from an open technique to a limited incision to endoscopic release. in addition, partial excision of the flexor retinaculum is advocated by some surgeons because of obtaining better outcomes. however, the procedure is difficult to be accomplished through small incisions owing to poor visualization. currently, balance of incision, visualization, and partial excision of the flexor retinaculum is still controversial. the objective of this report is to introduce carpal tunnel release with partial excision of the flexor retinaculum through two small incisions. the procedures were performed under lighted head magnifier. this is the first report on the use of our technique. for comparison, the investigators also included two other groups of standard open carpal tunnel release with partial excision of the flexor retinaculum and endoscopic carpal tunnel release without excision of the flexor retinaculum.

Eligibility criteria:
inclusion criteria: * diagnosis of ctr was established based on evidence for surgical treatment issued by the british society for surgery of the hand (2003) * patients with moderate, severe, and very severe symptom. exclusion criteria: * mild symptom. * finding had a ganglion based on preoperative ultrasound. * associated with infection, gout, or diabetes. * patients who discontinued intervention and lost to follow-up.
low-dose maximal-intent versus controlled-tempo resistance training on quality-of-life in adults

Conditions: Quality of Life

Summary: the aims of this study were to: 1. compare the effects of low-dose maximal intent and controlled tempo resistance training on untrained healthy adults' quality-of-life, functional capacity, and strength. 2. qualitatively explore perceptions of maximal intent and controlled tempo resistance training.


Eligibility criteria:
inclusion criteria: * participants were eligible if they were between 30-60 years old * uninjured * had no cardiovascular or neuromuscular conditions * had not participated in lower-limb rt in the previous six months. exclusion criteria: * participants were excluded if they had either taken part in any lower-limb rt in the last six months * had underlying health condition(s) that prevented them from participating in rt * regularly met or exceeded the uk recommended pa guideline of 150-minutes of moderate to intense pa per week.

Keywords: activities of daily living balance independence mobility untrained
a clinical study on the efficacy and safety of hbm9161 in patients with itp

Conditions: Primary Immune Thrombocytopenic Purpura

Summary: to select a dose and to make a decision for phase 3 study

the onset of primary immune thrombocytopenia is thought to be increased platelet destruction and decreased platelet production due to anti-platelet antibodies. hbm9161 is a fully human anti-fcrn monoclonal antibody that can effectively remove pathogenic igg, thereby relieving platelet destruction and rapidly increasing platelet counts in patients. the study will be conducted in a phase 2/3 operational seamless design, with group dose a and dose b of hbm9161 and a placebo group in phase 2.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age at the screening visit, male or female. 2. persistent or chronic itp whose average number of platelet at the screening visit and pre-dose (at least 1 day apart) is \ 35 × 10\^9/l for any of two tests. no severe bleeding within 4 weeks prior to the screening visit. 3. patients who have received and failed at least 1 first line of itp therapy (glucocorticoids and/or intravenous gamma globulin), or who are contraindicated, intolerable, or refuse standard therapy. 4. patients will be allowed to use a stable dose of concomitant drugs for the treatment of itp. e.g., glucocorticoid, danazol, immunosuppressant (azathioprine, cyclosporine a, mycophenolate mofetil) and eltrombopag. exclusion criteria: 1. other autoimmune systemic diseases other than itp. 2. multi-lineage immune cytopenias, such as evan's syndrome, autoimmune pancytopenia. 3. secondary itp. 4. received a vaccine within 4 weeks prior to the first dose of the study drug or planned during the study. 5. use of anticoagulants or any agents that have antiplatelet effect or can affect thrombopoiesis within 3 weeks prior to the first dose of the study drug. 6. received blood transfusion within 1 week prior to the first dose of the study drug. 7. received the intravenous gamma globulin, anti-d immunoglobulin, or plasmapheresis within 2 weeks prior to the first dose of the study drug. 8. received high-dose dexamethasone or high-dose methylprednisolone within 2 weeks prior to the first dose of the study drug. 9. received recombinant human thrombopoietin (rhtpo) within 4 weeks prior to the first does of the study drug. 10. received rituximab or other non-rituximab anti-cd20 drugs within 6 months prior to the first does of the study drug. 11. treated with splenectomy within 4 weeks prior to first dose of the study drug. 12. any thromboembolic or embolic events within 12 months prior to the first does of the study drug. 13. serum total igg \< 700 mg/dl at the screening visit.

Keywords: itp
data analysis for drug repurposing for effective alzheimer's medicines (dream) - montelukast vs fluticasone

Conditions: Asthma

Summary: this study aims to evaluate the comparative risk of dementia/alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

this is a non-randomized, non-interventional study that is part of the dream study of brigham and women's hospital. dream is led by dr. madhav thambisetty, md, phd, chief of the clinical and translational neuroscience section, laboratory of behavioral neuroscience, national institute on aging (nia) intramural research program. this study aims to evaluate the comparative risk of dementia/alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility criteria:
please see https://docs.google.com/spreadsheets/d/1u8yfpnmhi5hprhyuy14tigd1cozcsawkflbyct7al_a/edit?usp=sharing or appendix a (https://drive.google.com/file/d/1uc_g8tj1ujojbas1p1gfayfzy7hw7xmq/view?usp=sharing) for full code and algorithm definitions. medicare timeframe: 2008 to 2018 (end of data availability). inclusion criteria: * 1. aged \>/= 65 years on the index date * 2. no prior use of montelukast and fluticasone anytime prior to cohort entry date * 3. enrollment in medicare part a, b, and d with no hmo coverage for 365 days prior to and including cohort entry date * 4. at least two claims with asthma diagnosis measured 365 days prior to drug init exclusion criteria: * 1. prior history of dementia measured anytime prior to cohort entry date * 2. prior history of nursing home admission in the 365 days prior to the cohort entry date
endothelial progenitor cells in umbilical cord blood in preeclampsia and iugr

Conditions: Preeclampsia; IUGR

Summary: the objective of this study is to determine whether there are alterations in the population of endothelial progenitor cells in umbilical cord blood samples of infants born in the setting of maternal preeclampsia or fetal growth restriction.

preeclampsia remains a significant cause of neonatal and maternal morbidity and mortality. this disorder is found in 5-7% of pregnancies and its incidence is increased in gravid patients with multiple gestations, chronic hypertension, renal disease, autoimmune disease, and at extremes of maternal age. it is responsible for 15% of preterm births which is accompanied by a resultant increase in neonatal morbidity and mortality. in developing countries, it is responsible for approximately 50,000 maternal deaths each year. no widespread intervention to prevent this disease has been found effective and the only effective treatment remains delivery of the fetus. to date, the cause of preeclampsia is not known although many agree that preeclampsia is a two-stage disease as described by roberts et al. with the placenta of central importance. the first stage involves poor placental perfusion usually a result of impaired vascular remodeling in early pregnancy or from maternal disease. this leads to the second stage, which is the maternal syndrome of preeclampsia and involves both endothelial and leukocyte activation. preeclampsia is associated with an increased maternal cardiovascular risk later in life. women with a history of preeclampsia demonstrate altered expression of angiogenesis-related proteins and increased insulin resistance as measured by the homeostasis model of insulin resistance. additionally, preeclampsia is associated with an increase in future cardiovascular risk in the fetus. endothelial dysfunction and abnormal regulation of vascular tone that is present in preeclampsia suggests abnormal development of vascular cells such as endothelial progenitor cells. the increased cardiovascular risk of neonates born in the setting of iugr and preeclampsia also suggests the possibility of abnormal development of endothelial progenitor cells in the fetal compartment in these disease states. the purpose of this pilot project is to determine the effects of preeclampsia/iugr on endothelial progenitor cells derived from fresh umbilical cord blood.

Eligibility criteria:
inclusion criteria: * pregnant women 18-45 * gestational age between 30-40 weeks plus: * uncomplicated pregnancy or * fetal estimated weight \<10% for gestational age or abdominal circumference \<5% or * preeclampsia by acog criteria: 1. htn \> 140/90 on two occasions 2. proteinuria \> 300mg on 24 hour urine specimen or 1+ on urine dip exclusion criteria: * non-reassuring fetal status * congenital abnormalities * multiple gestations * clinical chorioamnionitis * recent infectious disease (within 2 weeks)

Keywords: endothelial progenitor cells endothelial dysfunction
effect of pneumoperitoneum on cognitive function and regional cerebral oxygen saturation

Conditions: Pneumoperitoneum

Summary: the investigators hypothesized that the pneumoperitoneum with reverse trendelenburg position could alter the rso2 and early postoperative cognitive function.

laparoscopic gastrectomy requires a reverse-trendelenburg position and prolonged pneumoperitoneum and it could cause significant changes in cerebral homeostasis and lead to cognitive dysfunction. we compared changes in haemodynamic variables, regional cerebral oxygen saturation, and early postoperative cognitive function in patients undergoing laparoscopic gastrectomy in the reverse trendelenburg position with those patients that underwent conventional open gastrectomy.

Eligibility criteria:
inclusion criteria: * asa class i or ii, aged 20 to 70 yrs exclusion criteria: * patients with morbid obesity (body mass index \> 30 kg/m2) or a history of cerebrovascular or respiratory disease were excluded.

Keywords: pneumoperitoneum, cognitive function