Kornimate/medical-research-clean huggingface dataset:
tackling intrusive traumatic memories after childbirth

Conditions: Posttraumatic Stress Disorder; Intrusive Traumatic Memories

Summary: this single-blind waitlist randomized controlled trial aims to investigate the efficacy of a single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a visuospatial task (the computer game "tetris"), on childbirth-related intrusive traumatic memories (cb-itm) and other childbirth-related posttraumatic stress disorder (cb-ptsd) symptoms. women who report cb-itm after 6 weeks postpartum can be included in the study. participants will be randomly allocated to either the immediate treatment (it) group or to the waitlist (wl) group. women in the it group will first report their cb-itm in a daily diary during 2 weeks (diary 1). on the 15th day, they will meet a psychologist to receive the single-session behavioral intervention. they will then complete a daily diary during the 2 weeks post-intervention (diary 2) and during the 5th and 6th weeks post-intervention (diary 3). women in the wl group will report their cb-itm continuously during 4 weeks in diary 1 and 2 before receiving the same intervention on the 30th day. they will also complete a last diary during the 2 weeks post-intervention (diary 3). it is expected that women in the immediate treatment group (it group) will have fewer cb-itm in diary 2, in comparison to the wl group, for which we expect no significant change in the number of cb-itm between diary 1 and 2. this study will contribute to the development of a single-session behavioral intervention to reduce cb-itms and other cb-ptsd symptoms, which would reduce the distress experienced by mothers and may improve the well-being of the whole family.


Eligibility criteria:
inclusion criteria: * signed written consent * gave birth in one of the study centres * gave birth to a live baby * had at least 4 cb-itm over the past two weeks * childbirth happened at least 6 weeks ago exclusion criteria: * is not fluent enough in french to participate in the assessments * life-threatening illness of mother or infant * has an established intellectual disability or a psychotic illness * takes propranolol medication * alcohol and/or illicit drug abuse * is not able to distinguish itm linked to other traumatic events from cb-itm targeted during the intervention * has an ongoing psychological treatment in relation to her childbirth experience * is under 18 years old

Keywords: posttraumatic stress disorder childbirth behavioral intervention randomized controlled trial visuospatial task
analgesic efficacy and safety study of naproxcinod in subjects with osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: to study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of signs and symptoms of osteoarthritis.

this is a 13-week double-blind study followed by a 52-week, open-label, roll-over on active treatment study. these are randomized, parallel group, multicenter studies comparing efficacy and safety of naproxcinod, placebo and naproxen.

Eligibility criteria:
inclusion criteria: * men and women (40 or older) with a diagnosis of primary oa of the knee * must be a current chronic user of nsaids or acetaminophen * must discontinue all analgesic therapy at screening exclusion criteria: * uncontrolled hypertension or diabetes * hepatic or renal impairment * current or expected use of anticoagulant * a history of alcohol or drug abuse * candidates for imminent joint replacement * diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months * current medical disease that could confound or interfere with the evaluation of efficacy * participation within 30 days prior to screening in another investigational study
depo-medrol on psoas after llif

Conditions: Muscle Weakness; Pain, Postoperative; Paresthesia; Pain, Muscle

Summary: the goal of this study is to determine the effects of a corticosteroid administered to the psoas muscle following a transpsoas lateral lumbar interbody fusion (llif) on postoperative hip flexor weakness and thigh pain and numbness.

primary objective and outcome measure: * quantify the difference in thigh pain measured on the visual analog pain scale (vas) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery. secondary objectives and outcome measures: * quantify the difference in rates and severity of postoperative hip flexor weakness, and numbness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection. * quantity patient reported outcomes measures (proms) (eq5d, odi, and sciatica bothersome index between those that did and did not receive a depo-medrol injection. specifically: * eq5d: eur-quality of life 5 dimension questionnaire * odi: oswestry disability index * determine effect of depo-medrol application on fusion rates and how it differs between those that did and did not receive a depo-medrol injection. ancillary objectives and outcome measures: * to determine the effect of clinically relevant covariates including sociodemographic and comorbidities on the course of postoperative pain and associated outcome measures and whether the effect of these covariates moderate the effect of postoperative pain. groups: * control group (standard care) - 1cc gel foam powder mixed with thrombin * steroid group (standard care + study intervention) - 1cc gel foam powder mixed with thrombin and 80mg depomedrol

Eligibility criteria:
inclusion criteria: * patients from the practices of drs. singh, mallozzi, moss * transpsoas (ptp or ltp) lateral lumbar interbody fusion (llif) 1-3 disc levels with posterior instrumentation (open or mis) with or without laminectomy, must include l3-4 and/or l4-5 * patients who agree to be a part of the study * patients with lumbar disc degeneration * patients between ages of 18 and 75 exclusion criteria: * scoliosis \>10° * spondylolisthesis \>grade 1 * flatback deformity * patients with insulin dependent diabetes * patients with \>3 levels of fusion * alternative interbodies * chronic oral steroid users * patients with allergy/intolerance to depo-medrol or other steroids * patients requiring bilateral transpsoas approaches * patients with ipsilateral symptomatic hip pathology * revision fusion procedures * cases involving trauma, tumor, or infection * patient's not capable of providing consent themselves * non-fluent english speakers (for consenting reasons) * patients who are lost to follow-up before the two year follow up period

Keywords: lateral lumbar interbody fusion llif depo-medrol corticosteroid lumbar spine psoas muscle postoperative hip flexor weakness postoperative thigh pain postoperative thigh numbness
cohort of mexican children with diabetes mellitus (cmc-dm)

Conditions: Diabetes Mellitus

Summary: the aim of this study is the identification of complications in diabetes mellitus pediatric patients and to compare the clinical, anthropometric, and biochemical characteristics between children in the different types of diabetes mellitus.

diabetes mellitus is characterized by hyperglycemia resulting from defects in insulin secretion and/or insulin resistance in target tissues. this study identify the influence of pathogenic factors on the evolution of diabetes mellitus and in the presence of chronic complications.

Eligibility criteria:
inclusion criteria: * patients with confirmed diagnosis of diabetes mellitus exclusion criteria: -

Keywords: pediatrics
transcutaneous vagus nerve stimulation in private healthcare center

Conditions: Generalized Anxiety Disorder; Chronic Pain; Irritable Bowel Syndrome

Summary: this non-randomized, open-label study has the objective to study the effects and feasibility of transauricular vagus nerve stimulation (tavns) for patients suffering from generalized anxiety disorder (gad), chronic pain (cp) and irritable bowel syndrome (ibs) in a private healthcare centre.

the effects of tavns on gad, cp and ibs. participants were investigated during a 4-week period and a 2-month follow-up. groups (gad, cp, ibs) were assessed using questionnaires: anxiety (generalized anxiety disorder gad-7); cp (brief pain inventory short form questionnaire) and ibs (irritable bowel syndrome severity scoring system). tavns was performed using a standard transcutaneous electrical nerve stimulation (tens) device and ear clip electrodes plugged into the concha area of the left ear. all participants received a bi-weekly 30 minutes stimulation (8 sessions). we defined three different tavns parameters for each group in hertz (hz) and microsecond (µs), (gad: 20hz-80µs), (cp: 5hz-200 µs), (ibs: 3hz-250µs).

Eligibility criteria:
inclusion criteria: 1. age range 20-65 years old 2. patient suffering from either generalized anxiety disorder, chronic pain scoring and irritable bowel syndrome from moderate 3. patients meet the scoring standard questionnaires: mild to severe 4. patient can understand and answer the questions 5. patient exhibits symptoms for at least six months exclusion criteria: 1. reading difficulties 2. diagnosed left ear lesion 3. measured blood pressure under 100/60 with or without anti-high blood pressure medicine 4. active implant such as cochlear implant 5. wounds and skin disease in the left ear 6. recent head trauma or concussion 7. cardiac pacemaker 8. severe alcoholism 9. left cervical vagotomy 10. cholinergic or b blocking medicine 11. recreative drugs 12. diagnosed concomitant psychiatric comorbidity 13. diagnosed concomitant personal disorders 14. diagnosed pregnancy 15. diagnosed concomitant severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic infectious diseases uncompensated

Keywords: transcutaneous vagus nerve stimulation generalized anxiety disorder chronic pain irritable bowel syndrome private practice
re-thinking the role of peers and training patients [repeat]

Conditions: Cardiovascular Diseases

Summary: this study, re-thinking the role of peers and training patients \[repeat\], is designed to test the feasibility of training peer-coaches to prepare limited health literacy (lhl) patients to engage in shared-decision making (sdm) for cardiovascular disease (cvd) risk-reduction.

the investigators will use a 2-arm pilot rct design to assess the feasibility, and acceptability of the intervention. up to 60 primary care patients will be randomly assigned to participate in the peer-coaching or control group. patients will be randomized at a 1:1 ratio, stratified by the clinician. half of the subjects (n=30) will be assigned to the peer-coaching intervention, and the other half will be assigned to the control group.

Eligibility criteria:
inclusion criteria: * a patient of highland family medicine practice * at least 40 years old and no more than 75 years old * be at ≥10% risk for cvd as calculated using the ascvd risk estimator plus * no plans to leave the practice in the next 12 months * english speaking * limited health literacy (self-report) exclusion criteria: * have experienced a prior cardiac or vascular event such as myocardial infarction (mi) or cerebrovascular accident (cva) or have had a cvd procedure such as installation of a stent or angioplasty * gave peripheral vascular disease, intermittent claudication or peripheral arterial disease * lack of capacity to consent
improving the quality of patient care by using a clinical expert system.

Conditions: Hypertension; Diabetes; Hypercholesterolemia; Vasculitis; Coronary Heart Diseases

Summary: aim: to investigate the quality of history taking by physician and computer-based system. patients: 100 inpatients presenting at the rbk for the first time and treated in the departments of nephrology and cardiology. methods: the information obtained by the computer based system is compared with the information acquired by conventional history taking. study endpoint is the comparison of historical data organized according to the elements in a standard medical history on a patient-by-patient basis. study procedure history taking is performed by physicians according to the guidelines of the rbk. within 2 days thereafter the patient is interviewed with help of the cleos system with the support of a study nurse.

aim: to compare the completeness of history taking by physicians and by a computerized system interacting directly with the patients. historical data recorded in the patient record, including the discharge letter, were compared with the history acquired by computer-based interview of each patient. patients: 100 inpatients presenting at the rbk for the first time and treated in the departments of nephrology and cardiology. methods: the information obtained by the computer based system is compared with the information acquired by conventional history taking. study endpoint is the comparison of historical data organized according to the elements in a standard medical history on a patient-by-patient basis. study procedure after informed consent of the patients the procedure of history taking is performed by the physician according to the guidelines of the rbk. within 2 days thereafter the patient is interviewed with help of the cleos system \[a computer-based, history-taking program\] with the support of a study nurse. the physician will be informed about the results immediately after completion of the questionnaire. data of medical significance were extracted from the official hospital chart and the computerized history by clinically experienced physicians and tabulated on a patient-by-patient basis. data elements were compared across each category of the history for each patient interviewed. the relevance of the differences of the information obtained by the two systems was rated by an independent reviewer.

Eligibility criteria:
inclusion criteria: * all inpatients in a hospital environment exclusion criteria: * inability to give an informed consent
exercise-induced bronchospasm in cystic fibrosis

Conditions: Cystic Fibrosis; Bronchospasm

Summary: exercise is an important clinical feature in cystic fibrosis. better exercise capacity has been associated with better patient outcomes and quality of life. exercise-induced bronchospasm is a condition, often associated with asthma, which may make exercise difficult. the role that exercise-induced bronchospasm has in people with cystic fibrosis is unknown. this study is designed to determine how often exercise-induced bronchospasm occurs in cystic fibrosis.

we anticipate that visit 1 will take approximately three hours. this will include obtaining informed consent, completing baseline demographic and quality of life questionnaires, brief physical exam, measuring exhaled nitric oxide level, skin allergy testing, obtaining blood and sputum samples, and performing pulmonary function testing before and after bronchodilators. visit 2 will take approximately two and one-half hours. this will include performing eucapnic voluntary hyperventilation, measuring exhaled nitric oxide levels, and obtaining blood and sputum samples. visit 3 will take approximately two and one-half hours. this will include performing cardiopulmonary exercise testing followed by serial spirometry, measuring exhaled nitric oxide levels, and obtaining blood and sputum samples.

Eligibility criteria:
inclusion criteria: 1. males and females with confirmed diagnosis of cystic fibrosis: * 2 positive sweat chloride tests (or) * genetic testing 2. age 12 years and older 3. baseline fev1 ≥70% predicted 4. clinically stable over past 28 days: * no change in chronic respiratory symptoms * no need for antibiotics other then chronic maintenance therapies * no need for oral steroids * no increased use of bronchodilators 5. visit 1 fev1 within 10% of baseline exclusion criteria: 1. history of allergic bronchopulmonary aspergillosis (abpa) 2. chronic airway colonization with burkholderia cepacia (defined as 2 or more prior positive sputum or bal cultures) 3. pregnancy 4. chronic oral corticosteroid use 5. febrile illness within two weeks of visit 1 6. unable to provide consent (patients under age of 18 will require both parental consent and patient assent) 7. current cigarette smoking, cessation of smoking within 6 weeks of visit 1, or more than 10 pack-years of prior smoking

Keywords: to determine how often exercise-induced bronchospasm occurs in cystic fibrosis exercise-induced bronchospasm in cystic fibrosis
ziconotide as first-line idt

Conditions: Neuropathic Pain

Summary: the primary objective of this study is to prospectively examine outcomes in 12 patients using ziconotide intrathecal drug therapy(idt) as first-line monotherapy with the use of an algorithm of slow titration for dosing. the use of prialt has demonstrated fewer and less serious associated adverse effects as compared to idt morphine, especially when titrated slowly. we will use an average numerical rating scale as our primary outcome and the oswestry disability index(odi), beck depression inventory (bdi), pain catastrophizing scale (pcs), clinical global impression of change scale including binary satisfaction measures(cgic), lawton-brody instrumental activities of daily living(iadl) and short form-36 as secondary outcome measures.


Eligibility criteria:
inclusion criteria: 1. must be eligible for implantation of an intrathecal analgesia programmable pump system using ziconotide it. 2. must be 18 years of age or older for all points of data collection. 3. must be diagnosed with neuropathic pain secondary to a clear etiology. acceptable etiologies including but not limited to diabetic neuropathy, small fiber neuropathy, and post herpetic neuropathy. exclusion criteria: 1. must not have or been previously implanted with a programmable pump system. 2. untreated mental illness including depression or anxiety determined by preoperative psychological evaluation. 3. active substance abuse determined by preoperative urine drug screen. 4. unwillingness to decrease oral medications at screening. 5. any prior use of intrathecal analgesia besides trialing
efficacy of using mobile health applications for health

Conditions: Diabetes Mellitus, Type 2; Obesity

Summary: the purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes and type ii diabetes outcomes in type 2 diabetics. this study will involve a 6-month long commitment where participants will be expected to weigh themselves every morning, at the same time, and check their blood glucose readings daily before and after meals for at least three meals in the day.


Eligibility criteria:
inclusion criteria: * diagnosed with type ii diabetes for at least 3 months * between the age of 18-64 * bmi ≥ 25 * monitors blood glucose regularly (at least once per day) * owns or has access to a bathroom weight scale * owns a smartphone and willing to download mobile app exclusion criteria: * does not check blood glucose at least once per day * on medications that promote weight gain such as antipsychotic, antidepressant, and steroid hormone medications. medications for diabetes such as insulin, thiazolidinediones or sulfonylureas are oka

Keywords: diabetes mhealth ehealth
use of a diary to assess and monitor behavioral and psychological symptoms of dementia ( bpsdiary )

Conditions: Behavioral and Psychiatric Symptoms of Dementia

Summary: the goal of this randomized clinical trial is to compare the efficacy of the use of a diary to record behavioral and psychological symptoms of dementia (bpsd) in persons with dementia. the main questions it aims to answer are: * does the use of a diary lead to a reduction of the caregiver's burden at 3 months, compared with standard care? * does the use of a diary lead to a reduction of the neuropsychiatric inventory (npi) score at 3 months, compared with standard care? * does the use of a diary result in less psychotropic drugs prescribed to the patient at 3 months compared with standard care? * are physicians and caregivers satisfied with managing patients with the use of a diary? * does the use of a diary reduce the caregiver's stress related to bpsd at 3 months, compared with standard care? participants will be randomly assigned to either the use of a diary or a control group. caregivers in the diary arm will be asked to fill in a diary with bpsd including triggers, severity, day and hour, to be analyzed by physicians to prescribe appropriate pharmacological or non-pharmacological interventions. the control group will receive usual care (i.e., appropriate interventions will be applied after interviewing the caregiver and/or visiting the patient).


Eligibility criteria:
inclusion criteria: * diagnosis of cognitive impairment (neurodegenerative or vascular) * caregiver and patient willing to participate in the study * caregiver living with the patient or able to cover all 24 hours * presence of bpsd pertaining to the hyperactivity-irritability-impulsivity-disinhibition cluster (hida) * signed informed consent before the beginning of the study exclusion criteria: * refusal to consent to participate in the study

Keywords: behavioral and psychiatric symptoms of dementia randomized clinical trial diary
a trial for peroperative procedure and postoperative pain after rectal misoprostol or rectal hyoscine administration

Conditions: Hysteroscopic Surgery; Pain, Postoperative

Summary: dilatation of the cervix is necessary before operative hysteroscopic procedures. this dilatation with hegar dilators has certain difficulties and is associated with pain. cervical priming with various substances soften the cervix, ease the entry for the operation and decrease complications such as uterine perforation. the investigators aimed to compare rectally administered "misoprostol" and" hyoscine butyl bromide" with sham protocol.

the study is planned as a double blind randomised controlled one centre study. it will take part at a operative gynaecological department of a university hospital. women who apply to the university clinic who have a medical indication for hysteroscopic surgery will be recruited after informed consent. patients included in the study will be allocated to three groups. the intervention arms will be two arms and one sham group. the randomisation will be performed to three groups by a third party who is not involved in the surgical procedures. upon initial evaluation, a form evaluating age and other sociodemographic characteristics will be filled out before the scheduled hysteroscopy procedure. after completion of the initial form, rectal tablets will be administered according to the allocated group; two hours previously to the procedure. hysteroscopy will be under general anaesthesia with a 10 mm hysteroscope during the follicular phase of the menstrual cycle. during the procedure the duration of the cervical entry and total duration of the operation will be noted. additionally basal dilatation will be noted. two hours after the procedure pain will be documented according to the visual analogue scale which is a ten point scale. a value of "1" indicates "no pain". a value of "10" indicates "excruciating" pain.

Eligibility criteria:
inclusion criteria: * reproductive aged women * women who are scheduled for hysteroscopy for indications of endometrial polyp, submucous myoma or synaechiae exclusion criteria: * women who have undergone hysteroscopy previously * women who are in menopause

Keywords: misoprostol hyoscine butyl bromide cervical dilatation cervical ripening hysteroscopy pain