Kornimate/medical-research-clean huggingface dataset:
local infiltration analgesia with ropivacaine versus placebo in vaginal hysterectomy: a randomized, double-blind study

Conditions: Pain, Postoperative; Postoperative Nausea and Vomiting

Summary: the purpose of this study is to compare systematic local infiltration with ropivacaine 0.5 % vs. placebo in patients undergoing vaginal hysterectomy. the hypothesis is that systematic local infiltration will reduce postoperative pain and postoperative opioid consumption.


Eligibility criteria:
inclusion criteria: * eligible for elective vaginal hysterectomy * able to speak and understand danish * able to give informed consent exclusion criteria: * alcohol or medical abuse * allergies to local anesthetics * age \< 18 yrs. * intolerance to opioids
doxycycline to upgrade organ response in light chain (al) amyloidosis trial

Conditions: Primary Systemic Amyloidosis

Summary: in this study the investigators want to find out more about the addition of the antibiotic, doxycycline, to standard anti-amyloid therapy in people with amyloidosis. the investigators want to find out whether doxycycline improves the response to standard anti-amyloid therapy and whether it causes any problems (side effects).

organ response to anti-plasma cell therapy in al amyloidosis tends to lags behind hematologic response as chemotherapy may not clear pre-formed organ amyloid. doxycycline has been shown to have inhibitory effects on amyloid fibril formation as well as de-fibrillogenic effects and shown to be beneficial in in vitro, murine models and other preclinical studies. the investigators will prospectively evaluate the safety and efficacy of doxycycline in al amyloidosis patients when used in conjunction with anti-plasma cell chemotherapy.

Eligibility criteria:
inclusion criteria: 1. patients with biopsy proven al amyloidosis. 2. patients ≥ 18 years of age are eligible. 3. patient must provide informed consent. 4. all patients must have measurable amyloid organ involvement of a vital organ (eg. heart, liver, kidneys). localized amyloidosis will also be eligible as long as the amyloid involvement is radiologically measurable. 5. a negative pregnancy test will be required for all women of child bearing potential. breast feeding is not permitted. 6. patients who have previously been taking doxycycline will be eligible as long as there is no contraindication to stay on doxycycline 100 mg twice daily (bid) for 1 year in the opinion of the treating physician. 7. creatinine clearance of \>25 ml/min. exclusion criteria: 1. patients with severe malabsorption syndrome precluding absorption of oral agents will be excluded. 2. known intolerance or allergic reactions with doxycycline. 3. previous chemotherapy for al amyloidosis.

Keywords: al amyloidosis amyloidosis light chain amyloidosis
a research study of a new medicine nnc0113-6856 in healthy males

Conditions: Healthy Volunteers; Type 2 Diabetes

Summary: in this study nn0113-6856 will be given to humans for the first time. we will be looking into how safe different single doses of the new investigational product nnc0113-6856 is and we will measure its amount as well as the amount of specific parts of the new investigational product in blood. the study will look at the effects of different single doses of nnc0113-6856. this could either be as an oral dose (cohort 1 to 5) or one injection into the vein (intravenous \[iv\]-cohort). participant will get the investigational product either as one or two tablets (oral dose in cohort 1 to 5) or as injection into the vein (iv cohort). the study will last for about 6-10 weeks (up to 14 weeks in case of rescheduling for stand-by participants).


Eligibility criteria:
inclusion criteria: * male. * aged 18-55 years (both inclusive) at the time of signing informed consent. * body mass index between 20.0 and 27.0 kilogram per meter square (kg/m\^2)(both inclusive). exclusion criteria: * glycated haemoglobin (hba1c) greater than or equal to (\>=) 6.5 percent (%) (48 millimoles per moles \[mmol/mol\]) at screening. * use of tobacco and nicotine products, defined as any of the below: * smoking more than 5 cigarettes or the equivalent per day. * not willing to refrain from smoking and use of nicotine substitute products during the inpatient periods. * presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator. * history of major surgical procedures involving the stomach potentially affecting absorption of trial products (example: subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant * presence or history of pancreatitis (acute or chronic). * personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. * any of the below laboratory safety parameters at screening outside the below laboratory range, see "log of laboratory ranges used for laboratory parameter exclusion criterion" for specific values: * alanine aminotransferase (alt) greater than (\>) upper normal limit (unl) * aspartate aminotransferase (ast) \> unl * bilirubin \> unl * creatinine \> unl * international normalized ratio (inr) \> unl * precence or history of hepatitis
effects of one evening dose of 3 mg eszopiclone on next day driving ability

Conditions: Primary Insomnia

Summary: to assess next day driving ability and psychomotor/memory function following a single night time dose of eszopiclone in insomnia patients.

the study is a single centre, randomised, double blind, placebo controlled 2-way crossover design in a group of 32 male and female primary insomnia patients. the medications under investigation are eszopiclone and placebo. patients will receive the study medications and placebo on the evening of day 2 of each treatment period. performance will be assessed on day 3 of each treatment period. each treatment period will be separated by at least a 7-day washout period. this study was previously posted by sepracor inc. in october 2009, sepracor inc. was acquired by dainippon sumitomo pharma., and in october 2010, sepracor inc's name was changed to sunovion pharmaceuticals inc.

Eligibility criteria:
inclusion criteria: * aged between 18 and 55 years inclusive * in good health as determined by a medical history, ecg, haematology, blood and urine biochemistry and physical examination by the doctor * diagnostic and statistical manual of mental disorders, defined primary insomnia * a body mass index greater than or equal to 18 and less than or equal to 30 * registered with a general practitioner (gp) * hold a full current driving licence for at least one year, and be regular car drivers exclusion criteria * the use of any other medication during the study with the exception of oral, transdermal, iuds (progestogen only contraceptive e.g. mirena), or depot contraceptives, non-steroidal analgesics (e.g. ibuprofen), and paracetamol. a 7-day washout period is required for any patient currently receiving prescription or non-prescription sleep medication. * diagnosed sleep disorder or confirmed symptoms other than primary insomnia (e.g. restless leg syndrome, sleep apnoea) * significant history of mental illness, significant drug allergy, malignancy or chronic drug abuse (including alcohol) * any subject with known hypersensitivity to any of the study treatments * a sleep/wake cycle other than primary insomnia (e.g. shift work) liable to prejudice the results of the study * pregnant or lactating females, and females of child bearing potential not using effective contraception * patients who habitually smoke more than 5 cigarettes per day * caffeine consumption of more than 5 cups or glasses per day * history of alcohol or drug dependence or intake of more than the equivalent of 14 units of alcohol per week for females and 21 units per week for males * current participation in another clinical trial, or participation in a clinical trial within the last 90 days
cognitive checking intervention for maladaptive beliefs about memory

Conditions: Obsessive-Compulsive Disorder

Summary: a small (n = 24) pilot study developed a new and brief cognitive-behavioural therapy (cbt) module for checking symptoms (cbt-c) in obsessive-compulsive disorder (ocd). cbt-c targets maladaptive beliefs about memory and results show that it is effective at significantly decreasing checking symptoms as compared to a waitlist control. the objectives of the current investigation are to further investigate cbt-c by (1) replicating the pilot results in a larger sample; (2) using an active control condition (treatment as usual) as the comparison condition (3) including a 6-month follow-up, and (4) determining whether the association between maladaptive beliefs about memory at pre-treatment assessment are related to degree of checking symptom reduction following cbt-c. the findings of the study will have theoretical significance in adding to our understanding of the maladaptive belief domains relevant to the development and maintenance of ocd and supporting the cognitive model of compulsive checking. the relevant clinical significance is the further development of an intervention that could improve outcomes in treatment of persons with ocd. the key practical outcome of the research would be to add a stepped care offering to patients with ocd.


Eligibility criteria:
inclusion criteria: * adult over the age of 18 living in the province of manitoba, canada. * diagnosis of ocd with clinically significant levels of compulsive checking (i.e., able to meet the diagnostic criteria for ocd according to the diagnostic and statistical manual of mental disorders, 5th edition based solely on checking symptoms. other ocd symptoms may be present and checking does not need to be the primary symptom.) exclusion criteria: * active psychosis * active mania * presence of a substance use disorder that would interfere with participation in the treatment
to evaluate the treatment effect of an anti-infective agent for complicated infections (0826-053)

Conditions: Sepsis

Summary: to collect clinical response data with the use of ertapenem in community acquired sepsis.


Eligibility criteria:
inclusion criteria: * male or female patients, 18 years of age or older * patients present with at least two of the following signs and symptom: * fever (temperature\> 38c or \< 36c) * heart rate \> 90 beats/min) * respiratory rate\> 20 breaths/min) * high white blood cell count \> 12,000/ul or \>10% bands) exclusion criteria: * patient has a history of allergy or hypersensitivity (anaphylaxis) or serious adverse reaction to ertapenem or any carbapenem * patient has a poor chance of survival for more than 14 days. * patient has an apache ii score \> 15 (see attachment 3. * patient has an infection caused by pathogens resistant to ertapenem * the patient requires antibiotics other than ertapenem (such as: glycopeptides, macrolides or antifungal agents)
prolonged isolated thrombocytopenia after allo-sct : n-acetyl-l-cysteine (nac) versus supportive therapy

Conditions: Thrombocytopenia; Stem Cell Transplant Complications

Summary: isolated prolonged thrombocytopenia (pt) is a common complication after allogeneic stem cell transplantation with significant poor prognosis. no standard treatment is available. the current study assigned pt randomly to 2 arms: intervention arm with n-acetyl-l-cysteine (nac) and control arm with supportive therapy.this is a prospective randomized controlled study.

1. patients diagnosed with pt at day 60 post transplant will be randomized assigned to intervention arm (nac) or controlled arm (supportive therapy: prophylactic platelet transfusion was given when platelet count \<20000/ul.) 2. response will be evaluated at day 90. response was defined as platelet recovery to \>= 20000/ul for 7 consecutive days without transfusion support during the enrollment period. all the other patients not achieved above criteria was defined as no response. 3. for those without response in both arms, patients will received nac plus recombinant human thrombopoietin (rhtpo) for an additional 30 days. rhtpo was given at 300iu/kg/d for 28 consecutive days or platelet \> 50000/ul independent of platelet transfusion.

Eligibility criteria:
inclusion criteria: * age\>= 14 years * diagnosed as pt (defined as platelet count in peripheral blood never achieve 20000/miro-liter for 7 consecutive days without transfusion at day 60 post transplantation) * serum creatine level \< uln (upper limit of normal), serum alt/ast /tbil\<=2 uln * without active cmv/ebv/adv reactivation, active gvhd, without relapse or minimal residual disease at enrollment exclusion criteria: * history of asthma * allergy to nac * refuse to participate
the clinical study on the treatment of refractory ra with utaa91 injection

Conditions: Rheumatoid Arthritis (RA)

Summary: this clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study. the primary objective is to evaluate the safety of utaa91 injection in treating subjects with refractory moderate - to - severe active rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * aged ≥18 years (inclusive of the boundary value), with no restriction on gender. * expected survival time of at least 3 months. * subjects with refractory moderate - to - severe active rheumatoid arthritis who have failed standard treatment or lack effective therapeutic options. * meet the requirements for liver and kidney function, as well as cardiopulmonary function. * free from severe psychiatric disorders. * able to understand the trial and have signed the informed consent form. exclusion criteria: * a history of malignant tumors other than relapsed/refractory autoimmune diseases (r/r aid) within 5 years prior to screening. * subjects with positive results in virus/syphilis tests. * severe cardiac diseases or unstable systemic diseases. * active or uncontrollable infections requiring systemic treatment within 7 days before administration; evidence of central nervous system invasion at screening. * pregnant or breastfeeding women, female subjects planning to become pregnant within 2 years after cell infusion, or male subjects whose partners plan to become pregnant within 2 years after their cell infusion. * subjects who have received car - t therapy or other gene - modified cell therapies before screening. * subjects who participated in other clinical studies within 1 month before screening. * other conditions deemed unsuitable for enrollment by the investigator.
prevalence and predictors of esophageal thermal lesions in high-power-short-duration ablation of atrial fibrillation

Conditions: Esophagus Injury; Atrial Fibrillation

Summary: patients with documented atrial fibrillation who were referred to our clinic for catheter ablation will undergo standard hpsd ablation and subsequent esophagoscopy. after esophagoscopy patients will be followed up for one month in the form of a telephone follow-up. the primary endpoint of the study assessed by esophagoscopy performed on the day after the index catheter ablaton is the incidence of esophageal thermal lesions. secondary endpoints include: 1. the size of the esophageal thermal lesions. 2. the severity of esophageal thermal lesions.


Eligibility criteria:
inclusion criteria: * atrial fibrillation documented in the 12-lead ecg * indication for catheter ablation in accordance with currentn esc guidelines exclusion criteria: * pregnancy * women of childbearing potential without a negative pregnancy test within 48 hours prior to ablation procedure * known intracardiac or other thrombi * contraindication to anticoagulation * contraindication to esophagoscopy: diseases and deformities of the cervical spine, esophageal varices

Keywords: atrial fibrillation esophagus injury pulmonary vein isolation esophagoscopy
parental involvement in enteral nutrition in neonatal units

Conditions: Premature Birth

Summary: * hypothesis : bolus feeding of the newborn with a syringe under parents' visual control increases parental presence when compared to enteral feeding with a syringe pump. * main criteria : comparison of parental presence (mean time in hours) between the two arms : pushed bolus syringe feeding under parent's visual control and enteral feeding with a syringe pump.

* nutrition is the cornerstone of neonatology. adequate nutrition is necessary for a healthy brain growth and a physiological development. when oral feeding skills are not acquired, enteral feeding is used via a nasogastric tube by an electric syringe pump. the birth a premature child jeopardizes parent-infant bonding and hinders parental feeding skills. family-centered care has shown to be beneficial for the child and his parents by promoting early interactions, which lay the foundations for the child's psychological development. as such, pushed bolus enteral feeding by the parents with a syringe has been a common practice in sweden since the 1980s to involve the parents in enteral feeding practices. in france, this practice has been used in neonatal intensive care units (nicu). two french studies on this subject have been published. one focused on using parental pushed bolus enteral feeding in a hospitalization at home setting, whereas the other study investigated the impact of parental observation on pushed bolus enteral feeding. to our knowledge, there is no study proving the superiority of bolus feeding with a syringe under parents' visual control over enteral feeding with a syringe pump. * this study is an open-label, randomized, comparative interventional study with an intention-to-treat analysis. we compared a control group (enteral nutrition with an electric syringe pump while the neonate is lying in a cocoon or carried by their parent) to an intervention group (pushed bolus enteral nutrition under parents' visual control) * in the control group, enteral feeding used an electric syringe pump. * in the intervention group, the first enteral feeding is pushed with a syringe by the nurse. following enteral feeding attempts are pushed with a syringe by the parents only if they can or will grow. bolus feeding speed is at the discretion of the person pushing the syringe (nurse or parent) and is adjusted to the child's signs of discomfort. when the parents are absent, enteral feeding is carried out with a syringe pump.

Eligibility criteria:
inclusion criteria: * gestational age between 30 and 34 wa (weeks of amenorrhea) * patient affiliated to a social security scheme * hospitalized in neonatal intensive care unit (nicu) * 3 days of life or more exclusion criteria: corrected age\> 34wa and 4 days * mechanical ventilation or non-invasive ventilation with fio2\> 35% * serious congenital malformation * planned transfer to another hospital * enteral nutrition \<40ml / kg / day * immediate post-operative care * multiple pregnancy * poor understanding of french • secondary exclusion criteria * digestive rest greater than 5 days * death * no enteral nutrition pushed by parents
efficacy and safety study of intra-articular multiple doses of icatibant in patients with painful knee osteoarthritis

Conditions: Joint Disease

Summary: the primary objective is to compare the overall treatment effect on pain relief between icatibant and placebo. the secondary objectives are to assess the efficacy of icatibant in term of onset, extent and duration of pain relief relative to triamcinolone, to evaluate the safety of icatibant, to evaluate overall conditions of daily life after treatment with icatibant, to assess systemic exposure of icatibant following intra-articular injection.

this is a multinational, randomized, placebo-controlled study to be conducted in europe and the us. study medication will be administered by intra-articular injection 3 times in weekly intervals, being followed by an observation period of further 11 weeks.

Eligibility criteria:
inclusion criteria: * male and female subjects with painful osteoarthritis of the knee. exclusion criteria: * subjects presenting with diagnosis of oa \< 3 months and an oa grading \< k\&l grade ii, with any condition with impact on on the target indication, any test-compound-related condition, any study-related condition (all those conditions detailled in the csp).

Keywords: osteoarthritis knee
pet/ct scanning for the follow-up of antibiotic treatment of infectious osteoarthritis in the diabetic foot

Conditions: Diabetic Foot; Osteoarthritis

Summary: the investigators' primary objective is to assess the predictive power of pet/ct scanning in the evolution of infectious osteoarthritis of the diabetic diabetic after antibiotic therapy prescribed by national and international recommendations.


Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * patient has type i or type ii diabetes * patient consulting in the department of metabolic and endocrine diseases (caremeau hospital) or the department of nutritional diseases and diabetology (grau de roi medical center) at the nîmes university hospital * patient has infected osteoarthritis of the foot according to the international working group on the diabetic foot with a probability \> 50% (score \>= 2). exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant * the patient is breastfeeding * patient has severe sepsis or a stage 4 infection according to the international consensus on the diabetic foot * patient has severe renal insufficiency as defined by glomerular filtration rate \< 30ml/min/1.73 m\^2, calculated according to the mdrd equation, and is not undergoing dialysis * patient has a contra-indication for an mri * pacemaker * intracranial clips * metallic inclusions * severe claustrophobia
assessment of smartwatch samsung to monitor sleep quality: an observational prospective study - sleepex2 protocol

Conditions: Insomnia; Sleep Initiation and Maintenance Disorders; Health Status; Wearable Electronic Devices; Sleep

Summary: the goal of this study is to learn if a smartwatch is effective to identify factors related to sleep quality and habits of adults (30 years old or more), enabling the improvement and/or creation of instruments to assess overall health status and sleep quality. the main question it aims to answer is: - does the smartwatch application (software) indicate sleep habits and measure sleep quality in accordance to the standardized clinical instruments commonly used to assess sleep?

participants will answer questionnaires about overall health status, sleep quality and insomnia at the beginning, at 16 days follow-up, and at the end of the study. participants must use the smartwatch for at least a 12-hour period that includes night time, during a minimum of 30 consecutive days.

Eligibility criteria:
inclusion criteria: * adults (30 years old or more); * minimum score of 7 on pittsburgh sleep quality index; * capable of giving consent. exclusion criteria: * night shift workers; * skin condition that may interfere with optic sensor readings - such as lupus, atopic dermatitis, vitiligo; * tattoo on the wrist area that may interfere with optic sensor readings; * allergies or sensitivities to the components/materials of the smartwatch; * health condition that may be considered risky/unsafe by the medical team; * pregnant women.

Keywords: wearable electronic devices insomnia sleep quality