Kornimate/medical-research-clean huggingface dataset:
effect of dt56a (femarelle) on the coagulation system in the treatment of postmenopausal women

Conditions: Menopause; Thrombophilia

Summary: the purpose of this study is to determine if femeralle (dt56a) has an effect on the coagulation system, measured by platelet adhesion and aggregation, of normal and thrombophilic postmenopausal women.

women using hormone therapy (ht) are at an increased relative risk of venous thromboembolism (vte). the frequency of inherited factor v leiden and other risk factors for vte in the general population is estimated at 5-10%. this population has a 5-21 fold greater risk to develop vte. therefore, given the high thrombotic risk for the combination of hormone use and hereditary prothrombotic abnormalities these women's symptoms frequently go untreated for lack of alternative therapies. dt56a (femarelle) is a soy derived compound that has been shown to act as a novel selective estrogen receptor modulator (serm) in the alleviation of menopausal symptoms and prevention of postmenopausal bone loss without effecting the endometrium or the sex hormone blood profile. the research question of the current study is to assess the effect of femeralle on the coagulation system and determine if it is a reasonable and safe alternative for the treatment of menopausal symptoms in thrombophilic women.

Eligibility criteria:
inclusion criteria: * no previous exogenous estrogen exposure * symptomatic menopause: hot flashes, sleep disturbance, or other symptoms related to estrogen deficiency * menopausal (see above) exclusion criteria: * history of bleeding or thrombotic disorder * history of malignancy (particularly breast cancer) * diabetics * coronary artery disease * liver disease * concurrent anticoagulation therapy

Keywords: menopause thrombophilia factor v leiden estrogen replacement therapy hypercoagulability venous thrombosis
impact of single- versus double-layer hysterotomy closure on cesarean niche development: a randomized controlled trial

Conditions: Cesarean Section; Dehiscence; Uterine Bleeding; Uterus; Scar; Uterus Abnormal; Cesarean Section Complications

Summary: the objective of this randomized monocentric study is to assess potential variations in the incidence and severity of isthmocele morbidity among women undergoing cesarean section with either single or double-layer closure of the hysterotomy. our primary outcome aims to investigate whether there is a reduction in the median duration of intermenstrual spotting in patients belonging to the two respective closure groups

cesarean section, the most widely performed surgical procedure globally, has seen a significant increase in rates over the past decades, rising from 12.1% in 2000 to 21% in 2015 for various reasons. a recognized complication of cesarean sections is the formation of a uterine niche, commonly referred to as isthmocele. however, the true incidence of this post-operative complication remains uncertain, with reported figures ranging widely from 7% to 80%. the considerable variability in these estimates is attributed in part to the varying sensitivity of diagnostic tools. moreover, there is a lack of consensus in the literature regarding the definition of a cesarean niche, particularly concerning the dimensions of the defect. recent well-designed randomized controlled trials have investigated the long-term outcomes of single versus double-layer hysterotomy closure during c-sections. these studies found no significant differences in isthmocele incidence or intermenstrual spotting. however, limitations such as the lack of correlation between symptom severity and uterine defect dimensions, the inclusion of women in labor, and relatively short follow-up periods are acknowledged weaknesses, prompting the need for further analysis. our objective is to compare the outcomes of single versus double-layer hysterotomy closure in terms of intermenstrual spotting and isthmocele incidence in singleton women undergoing elective c-sections. crucially, standardizing the surgical suturing technique is essential to mitigate potential misleading outcomes resulting from inter-operator variations.

Eligibility criteria:
inclusion criteria: * nulliparous * singleton * age 18-45 * spontaneous pregnancy or autologous assisted fertilization * gestational age 38-40 weeks * elective c-section * informed consent exclusion criteria: * coagulopathy * autoimmune diseases * gestational diabetes * anticoagulant therapy * immunosuppressive therapy * endometriosis * uterine fibromatosis * spontaneous labour * connective tissue diseases
long-term follow-up gene therapy study for rpgr- xlrp

Conditions: X-Linked Retinitis Pigmentosa

Summary: this is a long-term follow-up study assessing safety of patients for up to 60 months following advanced therapy investigational medicinal product (atimp) aav5-hrkp.rpgr vector in participants with xlrp caused by mutations in rpgr.


Eligibility criteria:
inclusion criteria: * received aav5-hrkp.rpgr in the mgt009 study exclusion criteria: * unwilling or unable to meet with the requirements of the study
lifestyle redesign for schizophrenia

Conditions: Schizophrenia; Rehabilitation

Summary: this study aimed to investigate the effects of lifestyle redesign program plus treatment as usual versus treatment as usual on cognition, psychiatric symptoms, quality of life, and occupational engagement for schizophrenia.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia, based on the icd-10 diagnostic criteria for research (world health organization, 1992) * age from 20 to 65 * attending day care center regularly for at least 1 month and taking stable dose of medication exclusion criteria: * comorbid other mental disorder (e.g. depression, anxiety, adhd...etc.) * comorbid mental retardation * lacking the reading and writing skills
non-interventional registry study to evaluate the effectiveness of therasphere® in the treatment of hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this registry study is to gather effectiveness, qol, safety and procedural information on therasphere® for the treatment of participants with hepatocellular carcinoma (hcc), intrahepatic cholangiocarcinoma (icc) and liver metastases for colon cancer (mcrc) in real world clinical practice settings in france.

therasphere is a radioembolic therapeutic device used in the treatment of liver cancers. the goal of the registry study is to collect prospectively: participant description, treatment goal, treatment description, treatment results, safety, quality of life and survival data to ultimately demonstrate that therasphere treatment meets the claims that led to the reimbursement in france. the registry study is also an opportunity to improve the proper use of the device by team training especially for the personalized dosimetry treatment approach. clinical data will be collected and held in a secured, validated system and can be downloaded by biocomplatibles uk ltd data management on an ongoing basis. data verification will be performed by biocompatibles uk ltd data management and data validation checks will be created by the validated data system (with the biocompatibles uk ltd team performing user acceptance testing on them before they go live). adverse events and concomitant diseases will be coded according to the version of medical dictionary for regulatory activities (meddra) agreed with biocompatibles uk ltd. concomitant medications will be coded using the version of the world health organisation (who) drug dictionary agreed with the validated data system. appropriate study plans implemented to manage all aspects of the trial to ensure quality and integrity of the data collection.

Eligibility criteria:
inclusion: * participant has received a reimbursed dose of therasphere® * participant does not oppose to the collection of his/her medical personal data exclusion: * participant has opposed to data collection * participant has not received a reimbursed dose of therasphere® (free of charge dose)

Keywords: prospective registry therasphere® france sirt liver cancer, adult liver cell carcinoma hepatoma intra arterial treatment intra hepatic cholangiocarcinoma colon cancer metastasis
percutaneous biodegradable biliary stents for the treatment of benign biliary strictures.

Conditions: Biliary Stricture; Biliary Tract Diseases; Bile Duct Stricture; Bile Duct Injury; Stents; Obstructive Jaundice

Summary: to assess safety and effectiveness in the long term of percutaneous insertion of biodegradable (bd) biliary stents for the treatment of benign biliary strictures, in a single center experience.

this is an observational study (retrospective analysis on a prospective database) of patients that have been implanted a biodegradable stent in the biliary tree to treat benign stenosis. from march 2011 until may 2020, a prospective collection of clinical data has been conducted in patients with symptomatic benign biliary strictures treated biodegradable polydioxanone stents. a strict follow-up protocol has been carried out according to standard practice (at 2, 4, 6 months and every 6 months up to 5 years). once the follow-up is completed, the collected data will be analyzed, assessing the long term effectiveness and safety, but also other variables related to stent implantation and impact on patient's quality of life. a subgroup analysis of anastomotic biliary strictures will be performed.

Eligibility criteria:
inclusion criteria: * all patients over 18 years old attended in the interventional radiology department for the implantation of a biodegradable biliary stent (bbs: ella-cs, hradec kralove, czech republic), for each stenosis, by percutaneous technique. * written informed consent given exclusion criteria: * patients under 18 years old * patients with post-liver transplant biliary strictures * patients for whom no post-intervention follow-up data are available * patients in whom malignancy is demonstrated as a cause of the stricture after stent placement.
balance training after stroke with rewire

Conditions: Stroke

Summary: the study will include 20 patients after stroke, randomly assigned to the experimental and control group (10 each). in both groups, the program with last for five days; walking and balance will be assessed before and after the program. both groups will receive regular neurophysiotherapy; in addition, the experimental group will exercise each day by playing rewire games, while the control group will perform standing balance exercises.

detailed inclusion and exclusion criteria are specified in the appropriate section. both groups will perform the additional exercises for 15 minutes daily. in addition to the outcome measurement, informal feedback will be obtained from the patients and the therapists on the feasibility of the rewire system.

Eligibility criteria:
inclusion criteria: * first stroke * first admission to inpatient rehabilitation exclusion criteria: * less than 25 points scored on the mini-mental state examination * inability to walk independently

Keywords: exergaming physiotherapy balance
near infrared light for the treatment of painful peripheral neuropathy

Conditions: Peripheral Neuropathy

Summary: the purpose of this study is to determine if near infrared light therapy is effective in decreasing pain in patients with painful peripheral neuropathy. the hypothesis of the study was that the percentage of subjects with at least 40% improvement in visual analog scale score for pain after 4 weeks of treatment is higher for monochromatic near-infrared photoenergy (mire) treatment than for sham treatment.

pain is a very common symptom, between 65-80%, in patients with peripheral neuropathy. this study is designed to evaluate the effectiveness of monochromatic near infrared photoenergy therapy (mire) in the treatment of pain in axonal peripheral neuropathy. this will be compared with a placebo (sham) device. the mire is a fda approved, drug-free, non-invasive, medical therapeutic device that uses near-infrared light emitting diodes to deliver monochromatic near infrared photoenergy (mire) through contact with the skin. the effect of mire is believed to increase local blood circulation by dilating vessels and to reduce pain by decreasing local swelling and inflammation. mire is also thought to increase local levels of nitric oxide (no) which may decrease pain levels. study subjects will receive treatment with the device or the placebo device 3 times per week for 4 weeks. response will be measured during and after the treatment period.

Eligibility criteria:
inclusion criteria: * adults ages 18-85; able to give informed consent * documented painful, distal peripheral neuropathy of idiopathic cause, or related to impaired glucose tolerance or diabetes mellitus. * neuropathy documented by one of the following studies: nerve conduction studies and needle electromyography (emg); quantitative sensory testing of the foot with computer aided sensory evaluator (case iv); quantitative sudomotor axon reflex test (quantitative sweat measurementsystem \[q-sweat\]); neurology specialty examination; and neuropathy impairment score (nis) of less than 25. * stable pharmacotherapy for neuropathic pain for at least two weeks. * optimal pharmacotherapy has been achieved. * subjects cannot be on cyclooxygenase-2 (cox 2) inhibitors * pain visual analog scale (vas) of greater than or equal to 4/10 * subject has provided written informed consent * not currently using transcutaneous electrical nerve stimulation (tens) * not currently receiving acupuncture exclusion criteria: * pregnant or likely to become pregnant * current diagnosis of cancer * neuropathy impairment score (nis) of greater than 25. * diagnosis of severe neuropathy of known etiology for which specific treatment is available (i.e., acute and chronic inflammatory polyradiculoneuropathies, vasculitis, b 12 deficiency). * unstable diabetes mellitus defined as a hemoglobin a1c (hba1c) greater than 9%, and/or 10% of fasting blood sugars greater than 300 mg/dl for the week prior to enrollment.

Keywords: painful peripheral neuropathy light therapy
smartphone app for asthma self-care: assessment of outcomes (asthma progession and costs)

Conditions: Asthma

Summary: the goal of this clinical trial is to investigate whether a smartphone app based on the global initiative for asthma (gina) guidelines can improve asthma control and quality of life, and decrease asthma-related costs in children. the main question it to answer whether this app can improve asthma control, increase the quality of life, and decrease asthma-related costs. participants in the intervention group downloaded the asthma smartphone app, and followed up monthly via phone calls and clinic visits, while the control group received reminder calls. researchers will compare with the control group to see if the intervention receives more asthma control improvement.


Eligibility criteria:
inclusion criteria: * aged between 3 and 18 years; * who had access to the smartphone app; * with asthma treatment steps 2-4, requiring regular treatment with controller medication (for at least 6 months over the past year) according to the gina guidelines; * who had at least two clinic or emergency department visits related to asthma in the previous year. exclusion criteria: * children who had comorbidities, or other major medical problems, and who did not have a smartphone or whose caregivers did not have a smartphone were excluded from the study.

Keywords: smartphone selft-care system asthma control medical cost emergency room visit hospital admission
the effect of pnemoperitoneum on intracranial pressure and cerebral oxygenation during laparoscopic surgery according to anesthesia agents: propofol based total intravenous anesthesia vs desflurane anesthesia

Conditions: Optic Nerve Sheath

Summary: the pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of intracranial pressure (icp). previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (onsd) correlate with signs of increased icp. the aim of this study is to compare the effect of pnemoperitoneum on intracranial pressure and cerebral oxygenation during laparoscopic surgery according to anesthesia agents, propofol based total intravenous anesthesia (tiva group) and desflurane anesthesia (des group).


Eligibility criteria:
inclusion criteria: * adult patients (20-80 years of age) scheduled for laparoscopic cholecystectomy undergoing general anesthesia exclusion criteria: * patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery

Keywords: pneumoperitoneum optic nerve sheath diameter laparoscopy patients general anesthesia diameter
does hypnosis improve severe sleepwalking ?

Conditions: Sleepwalking

Summary: the aim of the study is to compare the benefit of two cognitive therapies in severe sleepwalking/ sleep terrors: relaxation vs. relaxation plus hypnosis. this is a monocentric, double-blind controlled study. 75 patients (aged more than 15 yo) with severe sleepwalking (defined as at least one epsidoe per week and at least two awakenings in stage n3 on video polysomngraphy) will be included. all patients will have a visit 1 for diagnosis including a medical interview, a video polysomnography, questionnaires on sleepwalking (padss and systematized interview), sleep quality (psqi, meq) and sleepiness (epworth scale) and suggestibility scale. 25 patients will be randomized to the relaxation group, 25 patients to the hypnosis plus relaxation group, while the 25 non-randomized patients will be non-treated controls. randomized patients will receive the therapy on day 1, and be monitored during the subsequent night. they will have a weekly therapy for 4 additional sessions and be monitored again on month 1, as well as they will complete the sleep and sleepwalking questionnaires. they will also complete the questionnaire by phone on month 3. the non-randomized controls will complete the questionnaire on month 1, with no therapeutical intervention between day 1 and month 1. the main outcome will be the frequency of sleepwalking episodes, as assessed by the padss-b. secondary outcomes include the changes in other subitems of teh padss, of the n3 awakenings in v-psg between night 1 and night 2 (short term effect) and night 1 and night 28 (long term effect), as well as changes in sleep quality and sleepiness scales. a comparison of spectral eeg, as well as respiration, eye movements, muscle tone and heart rate during rest, hypnosis trance, relaxation and sleepwalking episodes is also scheduled.

extended description of the protocol, including more technical information (as compared to the brief summary) if desired. do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures

Eligibility criteria:
inclusion criteria 1. \>15 years old 2. french speaker 3. having signed the informed consent form 4. affiliated to national health insurance 5. sleepwalking or sleep terrors (icsd-3 criteria); 6. at least 2 awakenings from n3 on night 1 videopolysomnography; 7. at least one episode per week. exclusion criteria 1. \< 15 years old 2. patient under guardian ship 3. patient unable to understand the protocol 4. patient unable, from investigator's opinion, to comply to the procedures of the trial, including the ability to practice self-hypnosis.

Keywords: sleepwalking sleep terrors arousal disorders f513 (cim-10) f514 (cim-10)
efficacy and safety of lyr-210 for the treatment of chronic rhinosinusitis in adults

Conditions: Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)

Summary: multicenter, phase iii, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.

this is a 52-week, multicenter, phase iii, randomized, blinded, controlled, parallel group with a 24-week treatment period followed by a safety extension phase with crossover or continued treatment to evaluate the efficacy and safety of lyr-210 compared with sham control for treatment in adults with crs.

Eligibility criteria:
inclusion criteria: * age ≥18 * diagnosed as having crs * undergone at least 2 trials of medical treatments in the past * mean 3 cardinal symptom (3cs) score * bilateral ethmoid disease confirmed on ct * has been informed of the nature of the study and provided written informed consent * agrees to comply with all study requirements * if on a waiting list for sinonasal surgery, willing to be removed from list or have surgery date cancelled for the duration of the study. exclusion criteria: * inability to tolerate topical anesthesia or endoscopic procedure * previous nasal surgery * presence of nasal polyp grade 2 or higher * seasonal allergic rhinitis * perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids * severe asthma * history or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis * obstruction preventing proper placement and retention of lyr-210 as seen on endoscopy * anatomic variation that, in the opinion of the investigator, would adversely impact placement of lyr-210 as seen on ct * known history of hypersensitivity or intolerance to corticosteroids * known history of hypothalamic pituitary adrenal axial dysfunction * previous pituitary or adrenal surgery * dental procedure/implant on maxillary dentition within 4 weeks of the screening visit. * past or present acute or chronic intracranial or orbital complications of crs * history or diagnosis (in either eye) of glaucoma or ocular hypertension * past or present functional vision in only 1 eye * past, present, or planned organ transplant or chemotherapy with immunosuppression * currently positive for covid-19 or residual sinonasal symptoms from a previous covid-19 infection * pregnant or breast feeding. females of child-bearing potential must test negative for pregnancy at the time of screening * evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments * currently participating in an investigational drug or device study * determined by the investigator as not suitable to be enrolled