Kornimate/medical-research-clean huggingface dataset:
a research study to compare a new weekly insulin, insulin icodec, and an available daily insulin, insulin degludec, both in combination with mealtime insulin in people with type 1 diabetes (onwards 6)

Conditions: Diabetes Mellitus, Type 1

Summary: this study compares insulin icodec (a new insulin) to insulin degludec (an insulin already available on the market) in people with type 1 diabetes. the study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily. participants will either get insulin icodec that participants will have to inject once a week on the same day of the week, or insulin degludec that participants will have to inject once a day at the same time every day. which treatment participants get is decided at random. participants will also get a mealtime insulin. the insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. the study will last for about 1 year and 2 months. participants will have 28 clinic visits and 28 phone calls with the study doctor. at 11 clinic visits participants will have blood samples taken. at 6 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. participants will be asked to wear a sensor that measures your blood sugar all the time. participants will be asked to wear it for a total of 57 weeks (around 1 year). women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility criteria:
inclusion criteria: * male or female aged greater than or equal to 18 years at the time of signing informed consent. * diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening. * treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) greater than or equal to 1 year prior to the day of screening. * hba1c below10% at screening visit based on analysis from central laboratory. exclusion criteria: * myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. * chronic heart failure classified as new york heart association (nyha) class iv at screening. * anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids). * uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
efficacy and safety of canakinumab in patients with colchicine resistant familial mediterranean fever

Conditions: Familial Mediterranean Fever

Summary: establish the safety and efficacy of 3 months treatment with canakinumab in patients with colchicine resistant familial mediterranean fever.


Eligibility criteria:
inclusion criteria: * male and female patients between 12 and 75 years of age with active type 1 fmf disease (according to tel-hashomer criteria for diagnosis of fmf) despite colchicine therapy (1.5 to 2.0 mg/day). * patients who are intolerant to effective doses of colchicine (1.5 to 2 mg/day) * patients with demonstrated minimum 1 typical acute attack per month and genetic confirmation of diagnosis (with at least one of the known mefv gene exon 10 mutations). patients with manifested amyloidosis are excluded. * patients must have a historical data showing a frequency of at least 1 attack/month within the last 3 months before they can be enter the run-in period. * patients must have type 1 disease characterized by recurrent and short episodes of inflammation and serositis with an average of at least 1 documented acute fmf attack per month during the previous 6 months and lasting approximately 12 to 72 hours. * patients treated with il-1 therapies must complete washout and have experienced at least 2 attacks since (e.g. anakinra: 3 day washout; rilonacept: 3 week washout) * patients treated with anti-tnf drugs must undergo appropriate washout. prior to randomization, use of etanercept must be discontinued for 4 weeks or use of adalimumab or infliximab must be discontinued for 8 weeks. * female subjects of childbearing potential must be using two acceptable methods of contraception * patients treated with interferon therapies must complete 1 month washout period. exclusion criteria: * patients with end-organ dysfunction due to amyloidosis (e.g. existing biopsy proven amyloidosis or proteinuria \> 0.5 gram per day) * patients taking steroids within 1 month prior to baseline * presence or history of any other inflammatory rheumatic disease * positive ppd test (according to local guidance) where a latent or active tb infection cannot be excluded via quantiferon (t-spot or radiographic imaging if needed). * patients who are pregnant or lactating * presence of any active or chronic infection or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 30 days or oral antibiotics within 14 days prior to screening * history or a malignancy within the last 5 years, except for successfully excised squamous or basal cell carcinoma of the skin other protocol-defined inclusion/exclusion criteria may apply

Keywords: familial mediterranean fever canakinumab colchicine resistance
dysport® pediatric lower limb spasticity follow-on study

Conditions: Cerebral Palsy; Muscle Spasticity; Children

Summary: the purpose of this research study was to determine the long term safety and efficacy of repeated treatments with dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.


Eligibility criteria:
inclusion criteria: subjects were eligible for participation in the study if they met the following criteria: 1. completion of the double blind study (study 141) up to the week 12, week 16, week 22 or week 28 follow up visit. 2. without any major protocol deviations and/or any ongoing adverse events (aes), either of which, in the opinion of the investigator would pose an unacceptable risk to the subject were he/she to continue receiving treatment in this open label extension study. 3. written informed consent obtained from the child's parent(s)/guardian(s) for this study, and assent from the child when and where applicable. exclusion criteria: subjects were excluded from entering the study for the following reasons: 1. major limitation in the passive range of motion at the ankle, as defined by maximum ankle dorsiflexion measured by the angle of arrest (xv1) at slow speed \<80° (ts angle) in the most affected leg to be injected. 2. unwillingness or inability to comply with the protocol. 3. current need for surgery for spasticity of the gastrocnemius-soleus complex (gsc) and/or hamstring muscles (and/or tendons) in the most affected leg to be injected. 4. treatment with any drug that interferes either directly or indirectly with neuromuscular function (e.g. aminoglycoside antibiotics) or neuroblocking agents used during surgery (e.g. curare) within the last 30 days prior to study medication or a planned treatment with such drugs. 5. be pregnant and/or lactating. 6. female subjects, not willing to use contraceptive measures throughout the course of the study if post pubertal and sexually active. 7. an infection at the injection site(s). 8. planned treatment with any new investigational drug or device during the study period.
effects of non-calorie sweeteners, mono- and disaccharides on intestinal barrier function

Conditions: Dietary Habits; Endotoxemia

Summary: the aim of the present study is to determine the effect of non-nutritive sweeteners on intestinal barrier function and inflammatory markers in healthy subjects in comparison to mono- and disaccharides.

in the intervention study normal weight participants will receive beverages sweetened with non-nutritive sweeteners, mono- and disaccharides for a defined number of days. before and after intervention parameters of intestinal barrier function will be assessed.

Eligibility criteria:
inclusion criteria: * no known history of metabolic diseases/disorders * bmi \<25 kg/m2 exclusion criteria: * food allergies or intolerances (esp. fructose intolerance and malabsorption) * chronic disease of the gastrointestinal tract * renal insufficiency * taking drugs affecting lipid or glucose metabolism
relief study: lower limb pain relief after injection cycles in adults suffering from lower limb spasticity following stroke

Conditions: Lower Limb Spasticity

Summary: the objective of this study is to demonstrate the effect of intramuscular bont-a injections in relieving pain, in a broad population of patients who suffer pain as the primary problem associated with spasticity. thus, this study will help to expand the information that is available regarding the impact of bont-a treatment in routine clinical practice conditions. treatment goals can vary greatly from one patient to another and there is no unique, single outcome that reflects the treatment benefits in all the cases. therefore, this study with special focus on the achievement of therapeutic goals, will allow the identification of each patient's specific goals regarding the improvement of the functional outcomes, the quality of life and patient well-being.


Eligibility criteria:
inclusion criteria: * men or women age 18 years and above * post-stroke lower-limb spasticity * prior agreement with the patient to inject bont-a * if previously treated with bont-a, (at least 3 months interval between last injection and inclusion). * therapeutic goals agreed jointly with the patient * functional ambulation classification (fac) score 2-5 * capacity to comply with the protocol * written informed consent exclusion criteria: * documented positive antigenicity to botulinum toxin * neuromuscular disease * use of medications that interfere with neuromuscular transmission * severe muscle atrophy in any muscle to be injected * any other indication that might interfere with rehabilitation or the evaluation of results * any non-stroke spasticity diagnosis * pregnancy or nursing mothers * previous participation in any study using goal attainment scale (gas)
walking with overground robotic exoskeletons to improve arrousal in individuals with disorders of consciousness

Conditions: Traumatic Brain Injuries

Summary: this proposed study will examine a walking intervention to promote changes in conscious state in individuals with disorders of consciousness (doc) due to acquired brain injury (abi). recent practice guidelines highlight the need to develop interventions to arouse patients with doc, as current treatment options are scarce with limited to low-quality pharmaceutical and electrical stimulation approaches to improve outcomes. new data indicates patients with chronic doc may benefit from therapeutic intervention prioritizing repeated multimodal sensory (i.e., simultaneous vestibular, proprioceptive, and visual) input, but likely not attain comparable functional recovery to those who demonstrate early command following ability. interventions activating pathways of the cerebral consciousness network may leverage a substrate for recovery. we hypothesize that walking in an overground robotic exoskeleton (ore) is safe, feasible, and will simultaneously stimulate endogenous cognitive and automatic pathways associated with walking5 to promote changes in behavioral performance in individuals with doc.

the objective of this study is to evaluate the safety, feasibility and tolerability of using ore therapy with individuals who meet criteria for doc during inpatient rehabilitation while evaluating changes in behavioral performance, neurophysiology, and physiologic response to training. doc numbers are very small so our goal is to gather this pilot data to support a future multi-site efficacy study with other tbims center partners.

Eligibility criteria:
inclusion criteria: * individuals with doc who are receiving inpatient rehabilitation exclusion criteria: -

Keywords: tbi, disorders of consciousness, walking, exoskeletons
urine incontinence occurrence and sexual hormones in women with chronic spinal cord injury/disease - a pilot study

Conditions: Spinal Cord Injury; Urinary Incontinence; Menstrual Cycle

Summary: there is a knowledge gap about the influence of the menstrual cycle on bladder function in women with spinal cord injury. so far, studies regarding urinary incontinence have primarily focused on women after menopause. it has become clear that a lack of the sex hormone estrogen, which occurs after menopause, can lead to urinary incontinence. during the course of the menstrual cycle, women also experience fluctuations in their sex hormones, particularly estrogen. the estrogen level is highest before ovulation and decreases afterwards. the investigators aim to explore whether this drop in hormone levels could lead to more frequent urinary incontinence during this phase. in order to offer the patients optimal treatment for urinary incontinence, it is important to understand the potential causes behind it. participants will document their menstrual cycles and episodes of urinary incontinences over three menstrual cycles using a diary, saliva samples, and urine tests. this research project is a pilot study and is being conducted by swiss paraplegic research at the swiss paraplegic centre. the investigators are recruiting 12 participants who experience incontinence at least once a month and 12 participants who experience incontinence less frequently or not at all.


Eligibility criteria:
inclusion criteria: * women * age ≥ 18 years * chronic neurogenic bladder dysfunction due to acquired spinal cord injury * regular menstrual cycle (26-30 days/cycle) * written consent given * ui group only: ui at least once per month exclusion criteria: * detrusor overactivity in storage phase above 15cmh20 * oligomenorrhea or amenorrhea (infrequent or absent menstrual periods) * hormonal intake/contraception * intake of androgens * intake of drugs which interfere with female sex hormones significantly * individuals who underwent sex reassignment surgery * pregnant or breastfeeding women * women who are trying to conceive * gynaecological carcinoma * endometriosis * ovariectomy * current pelvic floor physiotherapy * reconstructive surgery of bladder * local irritation of the bladder, such as bladder tumour, bladder stones, acute urinary tract infection at study start * inability to follow study procedures (cognitive or language barriers)
ds-5565 phase iii study for renal impairment in japanese subjects

Conditions: Diabetic Peripheral Neuropathic Pain; Post-herpetic Neuralgia

Summary: investigate the safety and efficacy of ds-5565 in japanese subjects with diabetic peripheral neuropathic pain (dpnp) with renal impairment or post-herpetic neuralgia (phn) with renal impairment.

the primary objective is the safety and tolerability of ds-5565 in japanese subjects with moderate to severe renal impairment.

Eligibility criteria:
inclusion criteria: * at screening, creatinine clearance (using the cockcroft-gault equation): 15-59 ml/min * at screening, a pain scale of ≥ 40 mm * type 1 or type 2 diabetes mellitus at screening (for patients with diabetic peripheral neuropathic pain dpnp only)-. painful distal symmetric polyneuropathy (for patients with dpnp only) * post-herpetic neuralgia phn defined as pain present for more than 3 months after herpes zoster skin rash at screening (for patients with phn only) exclusion criteria: * hba1c (national glycohemoglobin standardization program) \> 10.0% (for patients with dpnp only) * previous use of neurolytic block (for patients with phn only)

Keywords: diabetic peripheral neuropathic pain post-herpetic neuralgia renal impairment
chlorhexidine vaginal preparation for reduction of post-cesarean endometritis and sepsis

Conditions: Postpartum Endometritis; Wound Infection; Chlorhexidine Adverse Reaction; Postoperative Fever

Summary: the study aims to assess the beneficial value of vaginal preparation with chlorhexidine gluconate 0.05% before cesarean delivery of cases in labor in reduction of postoperative endometritis, fever and wound complications compared to no preparation or using saline only.

despite the demonstrated effectiveness of the vaginal cleansing in the previous study, yet this has not been adopted within obstetric practice internationally and does not feature within the nice intrapartum guideline.7 this is may be due to concerns with exposure of the fetus to iodine-based substances, concerns with vaginal staining and allergy to iodine. iodine is an antibacterial agent, but becomes inactive by the presence of blood may limit its use. chlorhexidine show greater reduction in skin flora after application compared with povidone-iodine agents (0.5 and 4%) respectively and has a greater residual activity after application than other preparations and (unlike povidone iodine) it is not inactivated by the presence of blood. thus, there are a number of reasons to believe that vaginal cleansing with chlorhexidine would be an appropriate alternative to povidone iodine.8 there is one rct comparing povidone iodine with chlorhexidine gluconate for vaginal cleansing at cs. this suggested that chlorhexidine may be superior, and further research was needed.9 solutions that contain lower concentrations, such as chlorhexidine gluconate and acetate (0.05%) are usually well tolerated and may be used for vaginal preparation. with this preparation, there are no reported cases of allergy.8 importantly, no safety concerns for the mother or baby have been identified with chlorhexidine gluconate used for vaginal cleansing.10

Eligibility criteria:
inclusion criteria: 1. gestational age ≥28 weeks. 2. cases had cesarean section after start of labor. exclusion criteria: 1. women with known allergy to chlorhexidine gluconate or any of its ingredients. 2. women with diagnosed group b streptococcus (gbs) colonization. 3. women with active infection during the procedure. 4. women did not receive the standard preoperative antibiotic prophylaxis. 5. women with diagnosis of chorioamnionitis. 6. prolonged rupture of membranes \>7 days

Keywords: post-cesarean endometritis wound infection chlorhexidine vaginal preparation chlorhexidine adverse reaction
anti-gpc3 car-t for treating gpc3-positive advanced hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma

Summary: the goal of this clinical trial is to evaluate the safety and efficacy of anti-gpc3 scfv-41bb-cd3ζ-tegfr chimeric antigen receptor (car)-modified t (car-t) cells in treating patients with gpc3-positive advanced hepatocellular carcinoma (hcc).

primary objectives: 1. to evaluate the safety of intravenous administration of the anti-gpc3 car-t cells in patients with hcc or lung squamous cell carcinoma 2. to access the safety of anti-gpc3 car-t cells in hcc patients through catheter injection secondary objectives: 1. to evaluate the efficacy of anti-gpc3 car-t cells in patients with advanced hcc or lung squamous cell carcinoma 2. to monitor the serum cytokine and expression level of tumor markers such as afp, cea and gpc3 3. to assess the persistence in peripheral blood and intratumoral infiltration of anti-gpc3 car-t cells

Eligibility criteria:
inclusion criteria: * expected to survive more than 3 months * ps 0-2 * immunohistochemistry was confirmed to be gpc3 positive hepatocellular carcinoma * patients with no ability to receive tace combined with sorafenib * wbc\>3.5×1e+9/l,hb\>90g/l,plt\>75×1e+9/l * hbv dna copy number less than 100/ml * alt≤5uln, ast≤5uln, tb≤1.5uln, alb≥35g/l * understand this test and have signed informed consent exclusion criteria: * hepatic encephalopathy, autoimmune diseases, or any uncontrolled active disease that hinders participation in the trial * decompensated liver cirrhosis, liver function child-pugh c grade * portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous * long-term use of immunosuppressive agents after organ transplantation * screening indicated that the target cell transfection rate was less than 30% * invasive pulmonary embolism, deep venous thrombosis, or other major arterial / venous thromboembolic events occurred 30 days or 30 days prior to randomization * subjects had an active or uncontrollable infection requiring systemic therapy 14 days or 14 days prior to randomization * pregnant or lactating subjects * in the opinion of the investigator, the presence of a medical history or a history of mental state may increase the number of subjects associated with the risk factors associated with the study or study drug administration * subjects who have signed a written consent or who are in compliance with the study procedure; or who are unwilling or unable to comply with the study
significance of immunohistochemical expression of fascin-1 in colorectal carcinoma

Conditions: Cancer of Colon

Summary: colorectal carcinoma is a major health problem. as a malignant tumor, the malignant potential of colorectal carcinoma is based mainly on its ability to metastasis to different sites. fascin-1 is an actin binding protein which is involved in reconstruction of intracellular actin network, the latter enforces the neoplastic cell to invade surrounding structures.

colorectal carcinoma is an aggressive malignant tumor. it has high incidence of cancer-related morbidity and mortality. the malignant potential of a given neoplasm is based mainly on its ability to invade the surrounding vasculature and reach to distant sites, the latter is called metastasis. in order to metastasize to distant sites, the neoplastic cells must re-arrange the intracellular actin filaments into well formed intracellular assembly which enable the neoplastic cells to reach to distant sites. fascin-1 is an actin binding protein, it is involved in reconstruction of actin assembly. fortunately, fascin-1 could be blocked by newly developed medications, blocking of fascin-1 may limit the metastasis of colorectal carcinoma. in current study the investigators detect fascin-1 in colorectal carcinoma by immunohistochemical approach, then they correlated different levels of fascin-1 expression to tumor clinical and pathological criteria as patients' ages, sexes, tumor stages, nodal metastasis, vascular and per-ineural invasions.

Eligibility criteria:
inclusion criteria: * all cases of colorectal carcinoma. exclusion criteria: * cases diagnosed on basis of lower endoscopic biopsies or local resections without radical colectomy. * patients with preopoerative history of chemo or radiotherapy. * patients with poor clinical data.

Keywords: cancer colon fascin-1 actin assembly