Kornimate/medical-research-clean huggingface dataset:
sorafenib for residue disease after resection with curative intent

Conditions: Carcinoma, Hepatocellular

Summary: radical hepatic resection represents one of the treatment options offering a prospect for cure with 5-year survival rates up to 50%. however, unintentionally, quite a proportion of these "radical resection" actually turned out to be non-radical in nature. for these patients who actually received non-radical resection, their by year survival rates were much lower than those who received radical hepatectomy. in this prospective, non-interventional, multi-center study, we are planning to observe the patient characteristics of hepatocellular carcinoma (hcc) patients who have residual disease after resection with curative intent, as well as treatment pattern, safety and effectiveness of sorafenib for these patients.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed hcc and have residual disease after resection with curative intent and for whom a decision to treat with sorafenib has been made. the definitions of non-radical resection are as follows: liver tumor rupture or adjacent organ invasion, confirmed by intra-operative or post-operative pathology; positive resection margin, confirmed by post- operative pathology; lymph node metastasis confirmed by intra-operative or post- operative pathology; residue lesion confirmed by post-operative digital subtraction angiography (dsa); macroscopic/microscopic tumor thrombi of vein and/or bile duct, confirmed intraoperative / post-operative pathology; number of tumors \>=3, confirmed by preoperative radiographic inspection (ct, mri or bus), intraoperative bus, or post-operative pathology. afp alpha fetoprotein(afp) remains higher than upper limits of normal (according to local lab's range), confirmed by local laboratory test at least 2 months after surgery. * confirmation of complete response (no visible residual tumor), on the eligibility scan (ct or mri) by local radiological review, performed \>2 weeks after surgery; * patients must be followed up regularly after surgery (time interval and method based on physician's daily practice), have no documented tumor recurrence by eligibility scan (ct or mri) before sorafenib treatment; * patients must have physically/mentally recovered from surgery and considered to be able to tolerant sorafenib therapy, by investigator's judgment; exclusion criteria: * the approved local product label must be followed for the exclusion criteria
five lives med to improve cognitive function in mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: the goal of this randomized controlled trial is to determine whether the digital health app five lives med can improve cognitive function in people with mild cognitive impairment (mci). the main question it aims to answer is: can 12 weeks of using five lives med improve global cognitive function in people diagnosed with mci? researchers will compare with a control group who receives a leaflet with standard health information. participants in the intervention group will be asked to use the five lives med app 3 times per week at home for 12 weeks. all participants, in both groups, will undergo cognitive testing and will complete questionnaires at baseline and exit.

mild cognitive impairment is a significant public health concern. non-pharmacological interventions, specifically multi-domain lifestyle and computerised cognitive training interventions, offer an accessible, scalable, engaging and potentially effective solution to improve cognitive function. five lives med is an interventional digital health app consisting of a physical activity habit forming coaching programme and cognitive training exercises. the purpose of this study is to evaluate the efficacy of the five lives med device; the primary hypothesis is that there is a significant difference in moca scores between the intervention group and the control group after the 12-week five lives med intervention, with an effect size of d = 0.50 or greater favouring the intervention group. this is a multi-centre, randomised, single-blind, controlled study in participants aged ≥ 50 years with mild cognitive impairment. participants will be randomly assigned to the intervention (five lives med) or control group for a 12-week period on a 1:1 allocation ratio.

Eligibility criteria:
inclusion criteria: * diagnosis of mild cognitive impairment (also known as mild cognitive disorder \[icd-10-cm; g31.84\] or mild neurocognitive disorder (dsm-5) * age ≥ 50 * participant or informant is willing and able to give informed consent for participation in the study * ability to read and understand english (uk) or french (france) * access to a mobile phone (apple ios 12.4 or above or android 6.0 (marshmallow) or above) or ipad (apple ios 12.4 or above only) with internet connection (mobile or wifi). exclusion criteria: * diagnosis of dementia or evidence of functional impairment inconsistent with mci * severe visual impairment * currently undergoing any other cognitive remediation programme * currently taking part in any other investigational study that in the opinion of the investigator may impact the data integrity of the current study * physical impairment that makes using a mobile device impossible * lack of access to an informant * participant under guardianship * unwilling or unable to tolerate or engage with study procedures * physical impairment that makes standing/walking unassisted impossible.

Keywords: mild cognitive impairment cognitive training computerized cognitive training
assessment of burden disease in patients with mast cell disorders

Conditions: Mastocytosis; Cutaneous

Summary: the symptoms caused by mast cell disorders can have a significant impact on the state of health of individuals, constituting a real burden for them, and consequently altering their quality of life. it therefore seems important to clarify the impact on the quality of life, on the psycho-affective sphere, on professional life and on the direct and indirect costs caused by the disease, as well as on the "patient's remaining burden". it seems possible by a longitudinal study (patient follow-up over 1 year). primary objective is assessment of quality of life in adult patient with mast cell diseases at m0.

mast cell activation symptoms are due to the release of mast cell mediators after uncontrolled activation of mast cells. the release by mast cells of mast cell mediators (tryptase, histamine, prostaglandins, serotonin) results in mast cell activation symptoms, found in mast cell activation syndrome but also in mastocytosis. these symptoms interested the skin, gastrointestinal gut, pulmonary, cardiovascular and neuropsychiatric organs, etc. in mastocytosis, along with these symptoms of mast cell activation, the infiltration of different organs by abnormal mast cells produces many clinical signs related to the excess of monoclonal mast cells present in the organs. according to our clinical experience, the impact of mast cell disorder on various dimensions of life, including economic life, seems important, but it has never accurately evaluated.

Eligibility criteria:
inclusion criteria: * adult patient (\> 18 years old) with confirmed mast cell disorder according to international criteria * patient affiliated to social security regime exclusion criteria: * patient under legal protection (guardianship, curators or court order) * patient does not speak french

Keywords: burden quality of life mast cell disease work impairment
icontrol chronic kidney disease

Conditions: Chronic Kidney Diseases

Summary: the proposed study is responsive to the call for obtaining enhanced preliminary data for an external grant resubmission. the goal is to demonstrate a novel approach using digital health tools to help preserve kidney function. the investigators aim to adapt a previous behavioral intervention and conduct formative testing among patients with ckd. specifically, the investigators will: aim 1: modify an existing technology platform to build the icontrol ckd system and adapt intervention content to reflect behavioral guidelines for patients with mild to moderate ckd. aim 2: conduct qualitative interviews and user testing among patients with ckd to obtain feedback on the design of the intervention. aim 3: conduct a prospective cohort feasibility trial to assess the feasibility and initial acceptability of the icontrol ckd intervention.


Eligibility criteria:
inclusion criteria: qualitative interview: * age 18 or older * diagnosed with ckd (self-report) * proficient in english inclusion criteria: pilot groups: * age 18 or older * diagnosed with mild to moderate ckd (documented egfr ≥60 ml/min/1.73m2 plus albuminuria or egfr 45-59 ml/min/1.73m2 ) * diagnosed with diabetes and/or hypertension * proficient in english * access to a test-enabled mobile phone * willing to receive and send multiple text messages in a week
new ultrasound parameters for predicting birthweight

Conditions: Fetal Development

Summary: babies that are either very small or very big have increased perinatal morbidity and mortality. predicting which babies will fall into these groups is traditionally done with risk assessment and third trimester manual palpation, however neither of these techniques are sensitive and a considerable number of affected pregnancies are missed. this results in stillbirth for small babies or birth trauma for larger ones. serial scanning in the third trimester can improve detection rates but this is expensive and cannot currently be provided to all nhs patients. a more sensitive test that can be performed earlier in pregnancy would allow identification of at risk pregnancies allowing for increased monitoring. new three dimensional ultrasound techniques that measure volume and volumetric flow have become available that may allow this to happen. this study proposes to trial newer ultrasound techniques on a cohort of pregnant women. the findings from these scans will then be correlated with actual birth weights at the end of pregnancy to determine the ability of these parameters to act as screening tools for babies at the extremes of size.


Eligibility criteria:
inclusion criteria: * pregnant women the beginning of pregnancy to term exclusion criteria: * pregnancies in women previously affected by unclassfied fetal abnormality * multiple pregnancy
observational study to evaluate safety, efficacy and convenience of using novomix® 30 flexpen® in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2; Delivery Systems

Summary: this study is conducted in asia. the aim of this observational study is to evaluate safety, efficacy and convenience in using novomix® 30 flexpen® in type 2 diabetes under normal clinical practice conditions.


Eligibility criteria:
inclusion criteria: * all patients with type 2 diabetes, not adequately controlled on their current therapy, who were prescribed novomix® 30 flexpen® as monotherapy, or in combination with oha, in accordance with the approved labeling, are eligible for the survey.
an open label extension study of the efficacy of morab-003

Conditions: Epithelial Ovarian Cancer

Summary: an open label extension of the morab-003-002 study in order to continue the active patients in the morab-003-002 study on maintenance morab-003 infusions after the main study is closed.


Eligibility criteria:
inclusion criteria: * provision of informed consent. * subjects must have been enrolled in and have met the inclusion/exclusion criteria of the morab-003-002 study. * subjects must have achieved a normalization of ca 125 levels and/or cr or pr (or stable disease and an investigator's assessment of a clinical benefit) after morab-003 in combination with standard chemotherapy and have not yet met the criteria for disease progression during participation in the morab-003-002 study. * subjects must be currently receiving single-agent morab-003 maintenance therapy. exclusion criteria: • subjects that discontinued the morab-003-002 study for any reason.

Keywords: extension study epithelial ovarian cancer
neurocytotron in the treatment of autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: preliminary efficacy and feasibility of using neurocytotron in the treatment of autism spectrum disorder

experimental, pilot, one-arm, open-label, single-center, 13-month, single-center study to evaluate the effect of ncx neuronal regeneration treatment in subjects with autism spectrum disorder (asd) to explore the therapeutic effects of neurocytonix neuronal regeneration technology on asd symptoms. specific objectives include collecting preliminary safety and efficacy data, assessing appropriate dosing, and measuring the impact on participants' quality of life after treatment.

Eligibility criteria:
inclusion criteria: 1. male or female subjects with a confirmed diagnosis of asd according to dsm-5 criteria. 2. subjects ≥ 3 and ≤ 50 years. 3. subjects with asd severity grade 1 to 3 according to dsm-5 criteria. 4. to have the informed consent of the parents or legal representatives for the subject's participation in the study. 5. subjects must be physically able and willing to undergo the treatment sessions. 6. subjects must be medically and psychologically stable to participate in the study. exclusion criteria: 1. presence of medical conditions that could contraindicate the use of neurocytotron dm, such as severe neurological disorders and difficult-to-control epilepsy. 1. uncontrolled epilepsy is defined as: more than 1 generalized seizure in any month within the 3 months prior to the day 1 visit, or 2. history of any of the following within 9 months prior to the day 1 visit: prolonged seizures or repetitive seizure activity requiring administration of a rescue benzodiazepine (oral, rectal, etc.) more than once a month, seizures lasting more than 10 minutes, status epilepticus or epilepsy with autonomic involvement. 2. concurrent participation in other therapies or interventions for autism during the study period. 3. logistical or situational limitations that prevent regular attendance at treatment sessions. 4. history of significant adverse reactions to similar treatments or involving the use of anesthesia. 5. presence of serious behavioral problems or aggression that may affect the safety of the subject or staff during treatment sessions. 6. current or recent (previous 14 days) history of clinically significant bacterial, fungal, viral or mycobacterial infection. 7. subjects with magnetic implants, pacemakers, claustrophobia or any other condition that prevents them from entering or remaining in the dm neurocytotron.
meconium aspiration and tracheal suctioning-feasibility study

Conditions: Meconium Aspiration Syndrome

Summary: feasibility study to randomize non-vigorous newborn infants born through meconium-stained amniotic fluid to endotracheal suctioning or immediate resuscitation.

this will be a pilot feasibility trial of endotracheal intubation and suctioning versus routine resuscitation for term, non-vigorous newborns born through meconium-stained amniotic fluid to compare the incidence of meconium aspiration syndrome, extracorporeal membrane oxygenation or death.

Eligibility criteria:
inclusion criteria: * term newborns (\>37 weeks of gestation) * delivery through meconium-stained amniotic fluid * mothers \>18 years of age exclusion criteria: * no consent from mother * infant vigor at delivery (muscle tone and respiratory effort) * prenatally diagnosed major anomalies (excluding gastroschisis) * plan to not resuscitate infant * family does not speak english

Keywords: meconium neonatal resuscitation
treatment and medical care of patients with moderate-to-severe atopic dermatitis - treatswitzerland

Conditions: Atopic Dermatitis

Summary: as structured and detailed data on the management of ad, a common chronic inflammatory skin disease which has a high impact on patients' quality of life and socioeconomic burden, are not available in switzerland, the planned registry will overcome this gap. it will provide data on the medical care of patients with ad for health care research and allow to study the efficacy and safety of approved and available therapies for ad in daily life.

a prospective, non-interventional, national multicenter study in patients with moderate-to-severe ad. according to the availability of approved systemic drugs for the treatment of ad, the study will include children ≥12 years, adolescents and adult patients. the general goal of the ad registry treatswitzerland is to provide the scientific community with a disease-oriented prospective cohort of patients suffering from moderate-to-severe ad. the primary objective of the ad registry is the documentation of medical care given to patients with moderate-to-severe ad in order to assess the appropriateness of care. further objectives of the ad registry are: 1. to evaluate the psychosocial impact of ad; 2. to provide up-to-date epidemiologic data that allow investigating risk factors for favorable or unfavorable disease courses and comorbidities; and 3. to establish a research network and foster clinical research projects. the study procedures include: * no study related intervention will be performed * patients have to fulfill all inclusion criteria to be enrolled in the study. * included patients are prospectively followed for at least 24 months. a maximum duration of follow-up is not intended. * during the observation period, standardized study visits are performed to prospectively document patient characteristics, clinical data, patient-reported outcomes, reasons for treatment decisions, and satisfaction with treatment.

Eligibility criteria:
inclusion criteria: * age ≥ 12 years * ad according to the uk working party's diagnostic criteria (28) * moderate to severe ad as defined by * objective scorad \> 20 or iga ≥ 3 (moderate) or * currently on systemic antiinflammatory therapy for ad or * previous systemic antiinflammatory therapy for ad within past 24 months exclusion criteria: * refusal to sign the informed consent form
ppx and concurrent radiation for newly diagnosed glioblastoma without mgmt methylation

Conditions: Glioblastoma Multiforme

Summary: to obtain preliminary data in a randomized phase ii study whether ppx/rt improves progression-free survival as compared to temozolomide/rt for patients with gbm without mgmt methylation.

to evaluate the toxicities of ppx/rt to evaluate neuro-cognitive functional assessments of patients with gbm receiving ppx/rt to obtain preliminary data in a randomized phase ii study whether ppx/rt improves overall survival as compared to temozolomide /rt for patients with gbm without mgmt methylation to facilitate planning a phase iii study.

Eligibility criteria:
inclusion criteria: * histologically proven diagnosis of glioblastoma or gliosarcoma (who grade iv) * gbm must have unmethylated mgmt as determined by central laboratory * diagnosis of gbm must be made by biopsy or surgical excision, either partial or complete; as long as there is sufficient tissue to determine mgmt status * no prior chemotherapy or radiation for brain tumor * must be able to tolerate brain mris. \*a diagnostic contrast-enhanced mri must be performed postoperatively within 42 days prior to study registration. * kps \>60. * age \> 18 * life expectancy of at least 3 months. * absolute neutrophil count \> 1500/mm3, platelets \> 100,000/mm, * creatinine \< 2 x uln * alt or ast \< 3 x upper limit of normal (uln) and total bilirubin \< 1.5x uln. * patients with a prior history of low grade glioma who did not receive prior radiation or chemotherapy with transformation to grade iv brain tumor are eligible. * women must be non-lactating, and surgically sterile, post-menopausal or have a negative serum pregnancy test and agree to use adequate birth control. males must agree to use adequate birth control. * voluntary, signed informed consent. exclusion criteria: * acute infection or other medical condition that would impair study treatment * no other active invasive malignancy unless disease free for at least 3 years. * prior temozolomide or ppx. * prior use of gliadel wafers or any other intratumoral or intracavitary treatment are not permitted. * prior radiotherapy to the head or neck (except for t1 glottic cancer), resulting in overlap of radiation fields. * no diffuse leptomeningeal disease, or gliomatosis cerebri. * use of any other experimental chemotherapy drug within the 60 days prior to randomization and during the trial. (use of a non-chemotherapy investigational agent must be approved by the brown university oncology group)

Keywords: brain tumors glioblastoma multiforme gbm
antibiotic prophylaxis in bariatric surgery with cefazolin: concentration in adipose tissue

Conditions: Obesity

Summary: eighteen patients were given a dose of 2g cefazolin in anesthetic induction, supplemented with 1g delivered through continuous infusion during surgery. adipose samples, obtained at the beginning and end of surgery, were analyzed using high performance liquid chromatography. some published studies suggest that the dose of 2g does not supply the minimum inhibitory concentration for principal causal agents of surgical site infection. to determine the concentration of cefazolin in adipose tissue of patients undergoing bariatric surgery and to evaluate the relationship between concentrations obtained and body mass index (bmi).


Eligibility criteria:
inclusion criteria: * body mass index greater than 35 and less than 50kg/m2 exclusion criteria: * hypotension during surgery with use of vasoactive drugs * renal disfunction (creatinine \>1.5 mg/dl)

Keywords: obesity bariatric surgery cefazolin antimicrobial prophylaxis administration and dosage
temporomandibular dysfunction in patients with cervical disc herniation

Conditions: Temporomandibular Joint Dysfunction Syndrome

Summary: cervical spine problems are associated with temporomandibular joint (tmj) and related muscles.the aim of the present study was to investigate temporomandibular joint dysfunction (tmd) and pain in individuals with cervical disc herniation (cdh) according to the level of neck disability.

the study included diagnosed with cervical disc herniation. the participants were divided into two groups based on their the neck disability index (ndi) score: group 1 with no disability and mild disability and group 2 with moderate and severe disability. temporomandibular dysfunction and its severity, intensity of neck and temporomandibular joint pain was assessed.

Eligibility criteria:
inclusion criteria: * diagnosed with cervical disc herniation aged between 18 and 65, * who could read and write in turkish exclusion criteria: * individuals with a history of head and neck surgery, fracture, physiotherapy or medical treatment cervical or temporomandibular joint treatment within the last six months, * presence of any inflammatory rheumatic diseases, such as ankylosing spondylitis and rheumatoid arthritis, facial paralysis, infection, advanced osteoporosis

Keywords: temporomandibular joint dysfunction syndrome intervertebral disc displacement disability neck jaw