Kornimate/medical-research-clean huggingface dataset:
long-term, open-label, multicenter study assessing long-term cardiovascular risks

Conditions: Multiple Sclerosis

Summary: this study will evaluate if patients who had a serious cardiovascular event upon initiation of fingolimod are at risk to delevop long term other cardiovascular events

this was a multi-national, long-term safety study. patients enrolled in study fty720d2406 who experienced a cardiovascular event within 24-hours of fingolimod treatment initiation which led to overnight monitoring or met serious adverse event criteria, were eligible to participate in this study. patients who experienced a qualifying event in study cfty720d2406 started study cfty720d2409 approximately 6 months after the occurrence of the cfty720d2406 qualifying event. patients underwent mandatory assessments on a 6-monthly basis including 12-lead ecg, vital signs. other assessments were performed as per routine practice. the primary objective of the study was to estimate the long-term cardiovascular risk of fingolimod in patients who experienced a cardiovascular event during treatment initiation. the study has no stand-alone secondary objective. however data from the cfty720d2409 and cfty720d2406 studies will be pooled to supplement cfty720dd2406 study and support its primary and secondary objectives of evaluating the safety profile of fingolimod. the pooled data will be appended to this result upon completion of fda submission.

Eligibility criteria:
inclusion criteria: * patients participating in study fty720d2406 who experienced a serious cardiovascular event during their fingolimod treatment initiation or re-initiation which led to overnight monitoring or met seriousness criteria. * patients still on fingolimod after the this first dose serious event exclusion criteria: -treatment with any investigational drug unless it is received as part of a novartis sponsored ms study lasting less than 1 month

Keywords: multiple sclerosis, fingolimod, adult, fty720, inflammatory disease, demyelination, auto-inflammatory disease, relapsing-remitting ms, cfty720d2406
treatment of sleep disturbances in trauma-affected refugees

Conditions: Post Traumatic Stress Disorder; Depression

Summary: the overall aim of this study is to examine the effects of sleep enhancing treatment in refugees with ptsd.

background: sleep disturbances are often referred to as a hallmark of ptsd. in a sample of 734 trauma-affected refugees undergoing psychiatric treatment at competence centre for transcultural psychiatry (ctp) in the period 2008-2012 99% reported sleep disturbances and nightmares. in trauma-affected populations untreated sleep disturbances can uphold and exacerbate both sleep-related and non-sleep-related ptsd symptoms. sleep disturbances may also affect the efficacy of first-line ptsd treatment and constitute a risk factor for poor outcome of psychiatric treatment. it has been argued that effective treatment of sleep disturbances may accelerate recovery in ptsd. there is a lack of randomised clinical trials on this relation in trauma-affected refugees. the aim of this study is to examine sleep enhancing treatment in refugees with ptsd. materials and method: the study will include 230 refugees, diagnosed with ptsd, referred to ctp. patients who give informed consent will be randomised to four treatment groups. 1. treatment as usual (tau); pharmacological treatment according to algorithm and manual based cognitive behavioural therapy 2. tau and add-on treatment with mianserin 3. tau and add-on treatment with imagery rehearsal therapy (irt) 4. tau and add-on treatment with mianserin and irt results: this study is expected to bring forward new knowledge on both medical and therapeutic treatment of sleep disturbances in trauma-affected refugees.

Eligibility criteria:
inclusion criteria: * adults (18 years or older) * refugees or persons who have been family reunified with a refugee * ptsd pursuant to the international classification of diseases icd-10 research criteria * psychological trauma experienced outside denmark in the anamnesis. trauma is imprisonment or detention with torture (according to the united nation definition of torture) or acts of cruel, inhuman and degrading treatment or punishment. trauma can also be organised violence, long-term political persecution and harassment, or war and civil war experiences. * sleep disturbances/ psqi \>8 * nightmares/ htq score on nightmare item ≥ "a little" * signed informed consent exclusion criteria: * severe psychotic disorder (defined as patients with an icd-10 diagnosis f2x and f30.1-f31.9). patients are excluded only if the psychotic-like experiences are assessed to be part of an independent psychotic disorder and not part of a severe ptsd and/or depression * current abuse of drugs or alcohol (f1x.24-f1x.26) * known neurodegenerative disorder (alzheimer's disease (ad), parkinson's disease (pd), levy-body dementia (lbd)) * in need of admission to psychiatric hospital * pregnant and breastfeeding women and women of the reproductive age who wish to conceive during the project period. * allergy towards active ingredients or excipients in mianserin * lack of informed consent

Keywords: ptsd sleep refugee irt mianserin
retrospective comparison of pregnancy outcome of infertile patients after fresh and warmed single blastocyst transfer from 2014 to 2018.

Conditions: Primary Maternal and Neonatal Outcomes; Assisted Reproductive Technology

Summary: the investigators retrospectively analysed the maternal and neonatal outcomes following a single fresh blastocyst transfer and a single warmed blastocyst transfer from procedures performed between 2014 and 2018 in a tertiary level university based fertility clinic.

previous studies that analysed pregnancy outcomes in women who underwent frozen single blastocyst transfer have shown an increase rate of large for gestational age and very large for gestational age (zhang et al., 2019),increased maternal risks of placenta accreta and pregnancy-induced hypertension (ishihara et al.,2014),and lower risks of placenta previa, placental abruption, very pre-term birth, small for gestational age, and perinatal mortality (sha, yin, cheng,\& massey, 2018) than fresh blastocyst transfer. the main outcome of this study is to analyse the rate of live births with the relative gestational period and neonatal weight and still death and neonatal death per each single blastocyst transfer, both fresh and warmed. secondary outcomes include the incidence of obstetric pathologies, gestational diabetes and pre-eclampsia, and defects of placentation. the study database included all pregnancies occurred after both a single fresh and warmed blastocyst transfer between the five-year period from 2014 to 2018 at humanitas fertility centre. the inclusion criteria were all patients, without any age limitations, which underwent either fivet or icsi and only transferred a single blastocyst. with regards to exclusion criteria, the following were considered: ovodonation, suspended cycles and embryos which were subjected to pre-implantation genetic testing.the investigator performed a comparison of maternal and neonatal outcomes in these pregnancies which occurred in the same period of time and in the same age-group of women.

Eligibility criteria:
inclusion criteria: * infertile women, without any age limitations, which underwent either fivet or icsi and only transferred a single blastocyst (warmed or fresh). exclusion criteria: * ovodonation, suspended cycles, and embryos subjected to pre-implantation genetic testing.
clinical and prognostic value of sarcopenia in patients older than 70 years with diffuse large b-cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma; Grade IIIB Follicular Lymphoma

Summary: this clinical trial is a multicentric prospective study to assess the clinical and prognostic value of sarcopenia in patients older than 70 years with diffuse large b-cell lymphoma.

sarcopenia status is assessed by ct scan imaging on the overall survival at 18 months in patients older than 70 years with diffuse large b-cell lymphoma treated by r-chop.

Eligibility criteria:
inclusion criteria: * patients \>= 70 years * dlbcl, grade iiib follicular lymphoma or histologically proven transformed low grade lymphoma * whatever the ipi score and the performance status * treated by rituximab-chop or rituximab-mini-chop * ct scan imaging performed one month or less before inclusion * signed informed consent exclusion criteria: * no initial ct scan imaging performed more than one month before inclusion * positivity for hcv, hbv and hiv * anthracycline contra-indication

Keywords: 70 years old dlbcl rituximab-chop sarcopenia
what is the burden of housing in rural areas for individuals with hemiplegia?

Conditions: Hemiplegia

Summary: our objective is to examine the impact of residing in urban or rural areas on the utilization of healthcare services, self-efficacy, and quality of life among individuals with hemiplegia in turkey.

in this upcoming cross-sectional study, we will assess patients with hemiplegia who are scheduled to visit the physical medicine and rehabilitation outpatient clinic. each participant will undergo a personal interview to fulfill the stroke self-efficacy questionnaire (sseq) and stroke specific quality of life scale (ss-qol). we will utilize the hospital database to determine the frequency of emergency department visits, physical medicine and rehabilitation outpatient clinic appointments, and general practitioner clinic visits specifically for hemiplegia in the previous year.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of stroke. * giving consent. exclusion criteria: * not giving consent. * inability to read and comprehend. * severe cognitive impairments or communication difficulties. * severe visual or motor impairments
effects of a novel dietary intervention on body composition after laparoscopic gastric bypass surgery

Conditions: Obesity; Morbid Obesity

Summary: we propose to compare the standard of care with the use of a novel medical food in 6 bariatric surgery patients by measuring outcomes of body composition, quality of life, hair loss, muscle strength, resting energy expenditure, and biochemical parameters.

study summary the purpose of this pilot study is to compare a medical food intervention with the dietary standard of care at boston medical center, in obese women subjects undergoing roux-en y gastric bypass surgery. commercially available nutritional supplements will also be provided as part of the study's protocol. subjects will be selected from surgical candidates of the nutrition and weight management center who meet the study criteria. subjects will be randomly assigned to one of the 2 groups (treatment and control). subjects will be seen at the study site 2 weeks before surgery and 4 weeks, 8 weeks, 12 weeks, and 6 months after surgery (for a total of 5 visits). data recorded during the study visits will be used to assess post-operative progress and will include: body composition, resting energy expenditure, muscle strength, quality of life questionnaires, hair loss, and blood markers for insulin resistance, nutritional state, organ function, lipid profile and inflammation. safety indicators and compliance will also be monitored.

Eligibility criteria:
inclusion criteria: * obese and morbidly obese women (bmi 30 - 50) * 25 years and older undergoing laparoscopic gastric bypass surgery * present with at least either metabolic syndrome or diabetes exclusion criteria: * have smoked in the past 4 weeks * pregnant * allergic or intolerant to ingredients used in the study (e.g. soy and thiaa) * there is a sound medical, psychiatric and/or social reason as determined by the principal investigator (pi) that makes the subject unsuitable for the study

Keywords: laparoscopic gastric bypass surgery medical food body composition dietary intervention
peer-supported e-health intervention for college student weight management and mental health

Conditions: Depression - Major Depressive Disorder; Psychological Well Being; Obesity Prevention

Summary: this study will test whether adding peer support and online education can help college students manage their weight and improve their mood: we plan to enroll 300 full-time university students and randomly assign them to one of three six-month groups (monthly in-person health talks and weekly emailed tips alone; those activities plus biweekly peer-mentor meetings and an online chat group; or those activities plus a custom app delivering weekly lessons, monthly expert live q\&a, and self-tracking tools). we will measure weight, body mass index (bmi), and scores on standard questionnaires for depression (phq-9), anxiety (gad-7) and life satisfaction (swls) at baseline, three months and six months to compare the effectiveness of each approach. by identifying which combination of face-to-face support and digital tools produces the greatest improvements, we aim to inform low-cost, scalable programs to help students maintain a healthy weight and emotional well-being.


Eligibility criteria:
inclusion criteria: * full-time undergraduate students aged 18-25 years * baseline bmi ≥ 24.0 kg/m² * able to provide informed consent * owns a smartphone or computer with internet access * willing to attend monthly lectures and complete online modules exclusion criteria: * current participation in another weight-management or psychological intervention program * diagnosis of an eating disorder, severe psychiatric illness, or medical condition affecting weight (e.g., hyperthyroidism) * pregnant or planning pregnancy during the study period * any physical limitation precluding participation in light-to-moderate physical activity * inability to communicate in the language of intervention materials
registry of local recurrences after breast-conserving surgery

Conditions: Breast Cancer Recurrent

Summary: the relocc project is a prospective, multicenter, clinical study to register cases of local recurrence after breast-conserving surgery, in centers dedicated to the treatment of breast cancer, in portugal and spain. the comparison of the results obtained will allow the optimization of the treatment, making it increasingly personalized.


Eligibility criteria:
inclusion criteria: 1. female patients 2. age \> 18 years 3. patients who have previously undergone breast-conserving surgery as part of the treatment of invasive or non-invasive (in situ) breast cancer 1. and adjuvant breast rt: total (wbi) or partial (pbi) 2. without adjuvant radiotherapy to the breast 4. recent histological diagnosis of homolateral, invasive or non-invasive (in situ) breast carcinoma exclusion criteria: 1. male 2. age \< 18 years 3. stage 4 at diagnosis 4. patients operated outside the participating centers and for whom it is not possible to obtain complete information regarding the primary treatment 5. history of other primary invasive malignant tumor (except non-melanoma skin carcinomas) 6. patients already treated for another local recurrence of breast carcinoma 7. absence of clinical follow-up and records in clinical process

Keywords: breast cancer treatment local recurrences breast-conserving surgery
the struggle that is phenylketonuria : what do the patients and caregivers suffer from

Conditions: Psychological Well-Being; Caregiver Burden; Life Stress

Summary: objective: to assess the stress levels and life hardships of phenylketonuria patients and their parents.

study design: between january 2020 - june 2020, a total of 156 phenylketonuria patients and their parents who arrived for their regular examinations were included. parents were asked to fill the parenting stress index, zarit burden scale and the strengths and difficulties questionnaire and children over the age of eleven were asked to fill the rosenberg self-esteem scale, the stait-trait anxiety inventory and strengths and difficulties questionnaire.

Eligibility criteria:
inclusion criteria: * phenylketonuria patients exclusion criteria: * bh4 metabolism disorde * other chronic illness * pregnancy
observational prospective study of the success of single embryo transfer implantation related to level of follicular fluid cytokines expression in low responders infertile patients treated with r-hlh add-on therapy in a second controlled ovarian stimulation cycle.

Conditions: Female Infertility

Summary: the objective of our observational prospective study will be to compare, for women treated for infertility and included in a icsi program, the implantation rate and delivery rate obtained after the transfer of a single blastocyst , chosen in a group of patients on the basis of the embryo morphology and in the other group on the basis of both embryo morphology and follicular fluid cytokines content. 100 ivf infertile patients , aged 32-39 years, with normal ovarian reserve, previously stimulated for their first cycle with standard short protocol (gnrh-ant) and r-fsh alone, who have had a low ovarian response, fort \< 50% ( fort criteria, 2012; fort= pfcx100/afc), will be treated for the second cycle with standard short protocol (gnrh-ant) and r-fsh plus r-lh , according to the standard established by our clinical practice. patients will be part of one of the following groups: group 1: single embryo transfer on day 5, according to standard embryo morphological criteria group 2: single embryo transfer on day 5, chosen on the basis of both embryo morphological criteria and levels of cytokines measured in the individual ff.


Eligibility criteria:
inclusion criteria: * women age from \< 38 years * normal body mass index (bmi ) from 18 to 26 * parameters for ovarian reserve in the normal range (day 3 fsh levels \ 1.5 ng/ml ; afc (antral follicular count) \> 6 ) exclusion criteria: * polycystic ovary syndrome (pcos) * ovarian surgery * pelvic endometriosis * por according to eshre criteria

Keywords: r-hlh cytokines follicular fluid
evaluation of pain with lidocaine-mixed radiesse® injectable dermal filler

Conditions: Nasolabial Folds

Summary: to assess pain during nasolabial fold treatment using radiesse® injectable dermal filler mixed with lidocaine.

to assess pain immediately after nasolabial fold treatment with radiesse® injectable dermal filler mixed with lidocaine in one nasolabial fold compared to radiesse® injectable dermal filler without lidocaine in the contralateral nasolabial fold.

Eligibility criteria:
inclusion criteria: * is at least 18 years of age. * is a candidate for nasolabial fold treatment using radiesse. * understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month. * understands and accepts the obligation to present for all scheduled follow-up visits and is logistically able to meet all study requirements. * has approximately symmetrical nasolabial folds. exclusion criteria: * has received any type of treatment or procedures including surgery in the nasolabial folds. * has received neurotoxins in the lower half of the face in the past 6 months. * has received hyaluronic acid, calcium hydroxylapatite (caha) or collagen injections in the lower half of the face within past 1 ½ years. * has received polylactic acid, polymethyl methacrylate (pmma), silicone or any other permanent filler in the lower half of the face. * has nasolabial folds that are too severe to be corrected in one treatment session. * has a history of chronic or recurrent infection or inflammation that would preclude participation in the study. * has a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding. * is female and of child bearing potential and is pregnant or not using acceptable method of birth control. * has had any history of hypersensitivity to lidocaine or anesthetics of the amide type. * has a history of anaphylaxis or multiple severe allergies. * has received any investigational product within 30 days prior to study enrollment or is planning to participate in another investigation during the course of this study.

Keywords: moderate to severe wrinkles and folds such as nasolabial folds
a study of the efficacy and safety of two doses of topiramate compared to placebo and propranolol in the prevention of migraine

Conditions: Migraine; Common Migraine; Classic Migraine; Headache

Summary: the purpose of this study is to evaluate the safety and efficacy of two doses of topiramate (100 and 200 mg daily) versus placebo and propranolol in the prevention of migraine. the study will also assess dose response relationship of topiramate, estimate the relative efficacy of topiramate versus propranolol in prevention of migraine, and evaluate the effect of migraine prevention with topiramate versus placebo on health related quality of life.

this is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of two doses of topiramate versus placebo and propranolol in the prevention of migraine headaches. the study consists of 4 phases: baseline phase (evaluation of eligibility criteria and tapering of any migraine prophylaxis medications patients are taking), core double-blind phase (patients are randomized to receive either 100 milligrams\[mg\]/day topiramate, 200mg/day topiramate, 160mg/day propranolol or placebo for a total of 26 weeks), blinded extension phase (patients continue the same dose of medication until the sponsor terminates the study or a patient withdraws from the study), and taper/exit phase (medication of patients exiting from the study is tapered over 7 weeks). the primary hypothesis is that one or two topiramate doses (100, 200 mg/day) will be superior to placebo in the prophylaxis of migraine based on the change in the monthly (28 days) migraine period rate from the prospective baseline phase to the core double-blind phase. oral medication (100 milligrams\[mg\]/day topiramate, 200mg/day topiramate, 160mg/day propranolol, or placebo) during the 26-weeks core double-blind phase. doses may be continued until the termination of the study or withdrawal by the patients during the blinded extension phase.

Eligibility criteria:
inclusion criteria: * medical history consistent with migraine with or without aura according to the international headache society (ihs) for at least 1 year prior to the study * between 3 to 12 migraine periods and no greater than 15 headache days (migraine and non-migraine) per month during the baseline phase * no clinically significant abnormalities on neurological exams, electrocardiogram (ecg) or clinical laboratory test results at baseline * female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test) exclusion criteria: * patients with headaches other than migraine * patients with episodic tension or sinus headaches * onset of migraine after age of 50 years * patients who have failed more than two adequate regimens for migraine prophylaxis * patients who overuse pain medications or certain other medications

Keywords: migraine common migraine classic migraine headache topiramate propranolol prophylaxis prevention
long-term follow-up (ltfu) of subjects dosed with ntla-2001

Conditions: Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy; Transthyretin-Related (ATTR) Familial Amyloid Cardiomyopathy; Wild-Type Transthyretin Cardiac Amyloidosis

Summary: this is a follow-up study of subjects who received ntla-2001 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy.


Eligibility criteria:
inclusion criteria: 1. a subject has completed or discontinued from an intellia-sponsored clinical study in which a complete or partial dose of ntla-2001 was received. 2. a subject has provided informed consent for the ltfu study. exclusion criteria: none