Kornimate/medical-research-clean huggingface dataset:
study evaluating dvs-233 sr for treatment of vasomotor symptoms associated with menopause

Conditions: Menopause

Summary: primary: to assess the efficacy and safety of dvs-233 sr compared with placebo for treatment of vasomotor symptoms (vms) associated with menopause and to compare the bleeding incidence of dvs-233 sr and tibolone. secondary: to assess the effects of dvs-233 sr and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.


Eligibility criteria:
inclusion criteria: * postmenopausal women of age 40 to 65 seeking treatment for hot flashes with last natural menstrual period (lnmp) completed at least 12 months prior to screening. * minimum of 7 moderate to severe hot flashes per day or 50 per week recorded for 7 consecutive days * body mass index less than or equal to 34 kg/m2 using the nomograph for bmi. exclusion criteria: * history, presence, or suspicion of estrogen-dependent neoplasia; malignancy, or treatment for malignancy, within the previous 2 years. * active or recent arterial thromboembolic disease; history of venous thromboembolism * history of cerebrovascular accident, stroke, or transient ischemic attack - * presence of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy * persistent elevated blood pressure

Keywords: menopause
nimotuzumab in adults with glioblastoma multiforma

Conditions: Adults With Glioblastoma Multiforma

Summary: determination of efficiency of nimotuzumab in adults with glioblastoma multiforma

the objective of the present study is a comparison of treatment of patients with newly diagnosed glioblastoma multiforme grade iv. patients will be randomized in one of two arms when included. patients randomly assigned to arm a will receive nimotuzumab (osag 101) plus temozolomide concomitant with standard radiotherapy. patients randomised in arm b will receive standard radiotherapy plus temozolomide treatment.

Eligibility criteria:
inclusion criteria: * patient signed informed consent * newly diagnosed, histologically confirmed glioblastoma multiforme grade iv * condition is measurable by mri in at least one dimension * age 18-70 * karnofsky-index \> 40 * treatment in a study center * female patients with a childbearing potential must have a negative pregnancy test within one week before inclusion in the trial. those female and male patients admitted in the study must use a reliable method of contraception. * adequate haematological, renal and hepatic function: * leucocytes \>2.0x10\^9/l * hb\> 10g/dl * billirubin total \< 2.5x upper limit of normal (uln) * creatinin i.s. \< 1.5x uln * ast (got)/alt (gpt) \< 5x uln exclusion criteria: * patients with history of anaphylactic reaction to murine or humanized antibody * patients with evidence second malignancy * patients who are pregnant or patients who refused adequate contraceptive precaution (female and male) during the trial * pregnancy and lactation * other conditions considered by investigators as sound reasons for disqualification from enrolment into the study such as: potential non compliance with protocol requirement * no mri for tumour evaluation

Keywords: glioblastoma multiforma
clinical efficacy of cooperative parent-mediated therapy (c-pmt_in_asd)

Conditions: Autism Spectrum Disorder; Parent-Training

Summary: the research highlights the lack of studies assessing the effectiveness of evidence-based interventions for asd in community services. this rct study aims to evaluate the effectiveness of cooperative parent mediated therapy (cpmt), a parent coaching program previously shown to be effective in tertiary care settings.

fifty participants with asd (aged 2-10 years) and their parents were randomized into two groups: both groups received treatment as usual (tau), but only the experimental group participated in cpmt. the primary outcomes indicated significant improvements in parent-child interaction and benefits in adaptive skills, asd symptom severity, and parental stress levels in the cpmt group, whereas the tau group showed no notable changes. the study suggests that the cpmt model is effective in community healthcare settings, representing a significant advancement for asd therapy.

Eligibility criteria:
inclusion criteria: * age between 2 and 10 years; * clinical diagnosis of asd based on dsm-5 criteria ; * scores above the autism spectrum cut-off on the autism diagnostic observation schedule generic-ados-2 ; exclusion criteria: * 2 years \> age \< 10 years; * not received clinical diagnosi for asd in line with dsm-5 criteria; * absence of other major medical diagnoses (i.e., epilepsy, genetic syndromes); * absence of psychosocial treatment during the trial.

Keywords: neurodevelopmental disorders parent-child interaction community healthcare service additional therapeutic effects
short and long-term effects of prebiotic, probiotic and synbiotic on appetite and dietary intake

Conditions: Appetite; Dietary Intake; Body Weight

Summary: prebiotics and probiotics are thought to play a role in appetite control and body weight regulation; but little is known about this topic. this study was planned to examine the effects of inulin and lactobacillus casei 431 on short and long term fasting, satiety, dietary intake, and serum hunger and satiety hormone levels. the study consisted of 2 phases. in the first phase, a double-blind, randomized, crossover study design was used, and it was performed with 16 healthy male participants aged 19-30 years. in this phase, the prebiotic (200ml milk+16g inulin), probiotic (200ml milk + lactobacillus casei 431 \[\>106 cfu/ml\]+16g maltodextrin), synbiotic (200ml milk+16g inulin + lactobacillus casei 431 \[\>106 cfu/ml\]) and control (200ml milk+16g maltodextrin) test drinks were consumed with a standard breakfast on four separate test days by one week intervals, and their effects on dietary intake, hunger, satiety and appetite were assessed. the second phase was performed with 21 healthy male participants aged 19-30 years, using a placebo-controlled double-blind, randomized study design. participants consumed the control (200ml milk+16g maltodextrin) or synbiotic (200ml milk+16g inulin+ lactobacillus casei \[\>106 cfu/ml\]) test drinks for 21 days with their habitual diet. at the beginning and end of the intervention, blood samples were collected at 0., 30., 60. and 120. minutes following the test day protocol to analyse serum glucose, insulin, ghrelin, obestatin and pyy (peptide tyrosine tyrosine) levels. in addition, dietary intake, hunger, satiety and appetite of participants were compared.


Eligibility criteria:
inclusion criteria: * healthy male * 19-30 years old * body mass index (bmi) of 18.5-29.9 kg/m2 exclusion criteria: * being female * being younger than 19 years old or older than 30 years old * having a bmi that is lower than 18.5 kg/m2 or higher than 29.9 kg/m2 * smoking * having any metabolic disease * losing or gaining weight in the past 3 months * following a special diet * using any medicine which could affect the outcome of the study * having food intolerance and allergies * taking regular probiotic or prebiotic foods or supplements * not consuming breakfast or lunch regularly * being a professional athlete * having unhealthy eating attitude that assessed using three factor eating questionnaire (having cognitive restraint score \>13, uncontrolled eating score \>18, and emotional eating \> 6) * having depression that was assessed using beck's depression inventory (having a score \>9)

Keywords: prebiotic probiotic synbiotic hunger and satiety hormones
randomized controlled trial of miniaturized percutaneous nephrolithotomy with vacuum-assisted access sheaths versus conventional sheaths for treatment of nephrolithiasis

Conditions: Kidney Stone

Summary: the purpose of this study is to compare two variations of the mini-pcnl procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

in this study we aim to compare two variations of the miniaturized percutaneous nephrolithotomy (mini-pcnl) procedure which are both used for the surgical treatment of kidney stones. this procedure involves accessing the kidney via a small temporary tract that is placed through the patient's back during surgery. both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own. two procedure types will be investigated: 1. miniaturized percutaneous nephrolithotomy performed using a 16 fr (6 mm diameter) vacuum-assisted tube with suction capability to assess the kidney and extract the stone. 2. miniaturized percutaneous nephrolithotomy performed using a 16 fr (6 mm diameter) standard tube to assess the kidney and extract the stone. approximately 90 people will take part in this study at cleveland clinic. the duration of the study will include the day of the surgery and following hospital stay until postoperative follow-up appointment with the surgeon approximately 4-6 weeks after the procedure.

Eligibility criteria:
inclusion criteria: * patients with planned prone mini-pcnl and a preoperative ncct * primary stone size: 10-25 mm * pre-existing indwelling nephrostomy tube or ureteral stent permitted * age: ≥ 18 years old * gender: all * ethnicity: all * capable of giving informed consent * capable and willing to fulfill requirements of the study exclusion criteria: * anticoagulated or history of coagulopathy * congenital renal anomalies * prior ipsilateral upper urinary tract reconstructive procedures * conversion to open procedure * multiple access tracts * inability to give informed consent or unable to meet requirements of the study for any reason
comparison of asa and cfs in anesthesiology

Conditions: Frailty

Summary: in addition to the regular asa classification, patients would also be assigned the clinical frailty scale (cfs) during preoperative examinations in anesthesiology clinics. the aim is to compare the usefulness of asa and cfs categorization for predicting perioperative and postoperative complications and length of postoperative stay in elective surgeries.

cfs significantly correlates with complications in patients treated in emergency department. this study is expected to provide information on how cfs correlates with complications and length of stay in elective surgeries. in addition to the regular asa classification, patients would also be assigned the clinical frailty scale (cfs) during preoperative examinations in anesthesiology clinics. the respondents are all elective patients over 65 years of age who have not had previously recorded mental difficulties that interfere with their daily life. patients suffering from senile dementia would not be excluded from this study. after the treatment was completed, the medical history of each patient would be reviewed and statistically processed. the aim is to compare the usefulness of asa and cfs categorization for predicting perioperative and postoperative complications and length of postoperative stay in elective surgeries.

Eligibility criteria:
inclusion criteria: * all elective patients older then 65 years exclusion criteria: * earlier mental difficulties that affect everyday life, senile dementia is not exclusion criteria

Keywords: american society of anesthesiologists physical status; clinical frailty elderly treatment outcome
etrasimod dose-ranging versus placebo as induction therapy study in adult japanese subjects with moderately to severely active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in japanese subjects with moderately to severely active ulcerative colitis (uc) when administered for 12 weeks.


Eligibility criteria:
inclusion criteria: * japanese ancestry * diagnosed with ulcerative colitis (uc) ≥ 3 months prior to screening * having active uc confirmed by endoscopy * moderately to severely active uc exclusion criteria: * severe extensive colitis * diagnosis of crohn's disease (cd) or indeterminate colitis or the presence, history of a fistula consistent with cd * diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Keywords: ulcerative colitis apd334 etrasimod
a clinical study assessing the potential of piboserod for the treatment of heart failure

Conditions: Congestive Heart Failure

Summary: the purpose of this study is to determine whether piboserod, a serotonin-4 receptor antagonist, is effective for the treatment of patients with congestive heart failure.

despite intensive research for decades, mortality and morbidity in chronic heart failure remains quite high. there is an obvious need for new drugs, especially drugs which may have a different mode of action than the existing ones on the market. the purpose of this trial is to evaluate whether a new drug candidate, piboserod, has beneficial biological effects in stable outpatients with symptomatic heart failure receiving evidence based treatment for heart failure and to assess safety and tolerability of this treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chf (nyha class ii-iv) * locally determined lvef \< 0.35 (by cmr, echocardiography, lv angiography, or radionuclide cardioangiography) * stable sinus rhythm * stable evidence based pharmacological treatment for chf. exclusion criteria: * unstable patients hospitalised within last 2 weeks * baseline prolongation of qtc interval * atrial fibrillation at randomisation * mi or re-vascularisation last 3 months * stroke last 3 months.
a study of alks 5461 for the treatment of major depressive disorder (mdd) - the forward-3 study

Conditions: Major Depressive Disorder

Summary: this study will evaluate the efficacy and safety of alks 5461.


Eligibility criteria:
inclusion criteria: * have a body mass index (bmi) of 18.0 to 40.0 kg/m2, inclusive * agree to use an acceptable method of contraception for the duration of the study * have a major depressive disorder (mdd) primary diagnosis * have no more than 2 inadequate responses to antidepressant therapy (adt) in the current major depressive episode (mde) * additional criteria may apply exclusion criteria: * have a current primary axis-i disorder other than mdd * have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days * have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during lifetime * have attempted suicide within the past 2 years * have a positive test for drugs of abuse * are pregnant, planning to become pregnant, or breastfeeding * have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone) * have had a significant blood loss or blood donation within 60 days * additional criteria may apply

Keywords: major depressive disorder depression alkermes alks 5461 samidorphan
sleep and opioid use in patients undergoing total knee arthroplasty

Conditions: Opioid Use; Pain, Postoperative; Sleep; Delirium

Summary: prescription opioid misuse and its associated negative effects have become an epidemic in the united states, and post-operative opioid use contributes to this terrible problem. alternative strategies to opioid prescribing are thus highly sought after in the post-operative setting. importantly, sleep and pain have a bi-directional relationship, and inadequate or impaired sleep regularly occur following orthopedic operations. melatonin is an endogenous sleep hormone that can be administered exogenously, and that has been shown to have some potential as an analgesic agent. here, using the premise that melatonin may improve sleep and pain in the post-operative setting, the investigators propose a randomized clinical trial in 120 participants undergoing total knee arthroplasties. patients will be randomized to receive either sublingual melatonin 5 mg or matched placebo starting on post-operative day (pod) 0 and through pod . the investigators will measure post-operative opioid usage as the primary outcome, and post-operative pain scores as a secondary outcome. the primary safety outcome will be sedation level, as measured by the richmond agitation sedation scale (rass). sleep will be measured objectively using wrist-worn actigraphy. participants will be followed through pod 28, and will also have baseline data on sleep, pain, and cognition obtained prior to surgery.


Eligibility criteria:
inclusion criteria: * adults age 18 years and older * undergoing elective total knee arthroplasty (single knee) exclusion criteria: * non-english speakers * individuals with dementia * patients with liver cirrhosis * patients currently taking prescription sleep aids * patients with long-term (greater than 3 months prior to surgery), chronic opioid use
fdg pet/ct in breast cancer bone mets

Conditions: Estrogen Receptor Positive Breast Cancer; Bone Metastases

Summary: this study will evaluate baseline uptake on a fdg pet/ct scan in patients with breast cancer that has spread to the bones. a repeat fdg pet/ct scan will be done 4 weeks after the start of new breast cancer hormone treatment and again at 12 weeks after treatment start. the baseline uptake and change in uptake after the repeat scans will be compared to clinical long term outcomes such as time to progression and overall survival. in addition the uptake will be compared to the incidence of skeletal related events that are common occurrences in patients with cancer that has spread to the bones.

this is an observational study as all patients will receive the same research diagnostic test, an fdg pet/ct study performed at 4 weeks after starting new hormone treatment.

Eligibility criteria:
inclusion criteria: 1. adult patients, at least 18 years of age, with a history of pathologically confirmed er+ breast cancer 2. biopsy proven or clinically obvious documented bone metastases from breast cancer (with the majority of the disease burden in the bone) 3. patients planning to start new endocrine targeted therapy (any line of therapy is acceptable and any endocrine therapy is allowed) 4. willing and able to comply with scheduled visits and serial imaging procedures 5. agrees to allow access to clinical records regarding response to treatment and long term follow up. 6. be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines exclusion criteria: 1. women who are pregnant or breast feeding 2. uncontrolled diabetes mellitus (fasting glucose greater than 200 mg/dl) 3. inability to tolerate imaging procedures (e.g. claustrophobia, severe pain) 4. weight exceeding capacity of imaging table 5. previous treatment with radiation or surgery to a significant percentage of bony metastatic sites 6. treatment with marrow stimulating agents (e.g. granulocyte colony stimulating factor (gcsf)) within 3 weeks of baseline scan
the potential of a low glutamate diet as a treatment for pediatric epilepsy

Conditions: Epilepsy in Children; Epilepsy in Youth; Randomized Controlled Trial; Refractory Epilepsy; Diet Intervention

Summary: the study is investigating if following the low glutamate diet for 1 month, as compared to care as usual, can improve seizure frequency, severity, and duration; cognitive functioning; and/or quality of life in children with epilepsy.

epilepsy is estimated to effect 470,000 children within the u.s. about a third of epilepsy patients are refractory. for these patients, dietary therapy is an alternative option. however, current dietary therapies present issues with compliance, palatability, adverse events, and providing necessary nutrients for brain growth and development during childhood. a dietary option that can improve tolerability, increase compliance, and reduce or eliminate adverse effects, while also optimizing nutrient intake, is critical for the advancement of dietary therapy options in epilepsy. glutamate is found in the diet as a flavor enhancer; and is also an important neurotransmitter in the body which mediates seizure activity. dietary sources of free glutamate are common and include numerous food additives (including many hidden sources) and some items which naturally contain higher amounts of glutamate. the low glutamate diet reduces the consumption of free glutamate, while optimizing dietary micronutrient and antioxidant intake, which can protect against the negative effects caused by high glutamate concentrations in the brain. additionally, the low glutamate diet is balanced, nutritious and palatable, with no side effects. the study is investigating if following the low glutamate diet for 1 month can improve seizure frequency, severity, and duration; cognitive functioning; and/or quality of life, in children with epilepsy. participation in the study will be done virtually and over a 2- or 3- month study period, depending on group randomization. all participants will have the opportunity to undergo dietary training and follow the diet.

Eligibility criteria:
inclusion criteria: * 4 or more seizures per month * willing to keep all medications constant during the study. * all medications have remained constant for 30 days prior to study enrollment * any previously attempted dietary therapies stopped before study enrollment exclusion criteria: * known or suspected inborn errors of metabolism * non-english speaking households
hcv care pathway in ile-de-france

Conditions: Hepatitis C Virus

Summary: the main objective of this research is to evaluate a care pathway adapted to different category populations at risk of being infected with the hepatitis c virus in order to improve both the diagnosis turnaround times and the access to treatment. the aim is to allow a quick and effective access to diagnosis and treatment of hcv by strengthening the city hospital networks, access to early consultations and coordination of medical social actors.

the current estimation of infected persons with chronic hepatitis c in france is over 200 ,000. it appears that prevention, screening, care management, medical and social care of patients can be significantly improved especially among the most vulnerable populations. indeed, these new hcv infections are mediated by drug-using people, prisoners, migrants, men who have sex with men (msm) and who are supported too late and without real access to treatment.

Eligibility criteria:
inclusion criteria: * 18 years old and more * positive hepatitis c virus * patient having expressed a non-objection to participate in this research exclusion criteria: none

Keywords: care pathway hospital- private network early consultation