Kornimate/medical-research-clean huggingface dataset:
curcumin supplementation as an add on treatment for patients with inflammatory bowel diseases treated with vedolizumab

Conditions: Inflammatory Bowel Diseases

Summary: introduction: the pathogenesis of inflammatory bowel diseases (ibd) is characterized by dysregulation of the innate immune response it's associated with th1, th17 up-regulation, reflected by increased cytokine secretion including tnf-α. a main effective therapeutic interventions is blocking tnfα. vedolizumab, an anti integrin, is a new class of treatment designed to block trafficking of lymphocytes in the gut. clinical trials and real life experience response rates at week 6 range between 30-45%. curcumin suppresses nfκβ levels via alteration of tlr2/4 pathways lowering tnf-α upstream. curcumin is safe and efficacious in inducing response and remission in mild-moderate ulcerative colitis (uc) and maintaining remission when used as an add-on to 5asa derivatives, only with strict adherence to treatment overtime. objectives: facing the low rate of response to therapies in ibd, the need for new treatments and the use of combination strategies lead us to believe that combining vedolizumab and curcumin may have a synergistic effect and will enable optimal immunomodulation. hypothesis: concomitant oral curcumin in ibd patients with colonic involvement will augment remission rates as well as clinical and biochemical response. type of research and methods of data collection: a randomized controlled trial in 84 adults with colonic ibd (uc and cd). eligible patients are during vedolizumab induction, patients will randomized will be into curcumin or placebo. data will managed by investigators.


Eligibility criteria:
inclusion criteria: 1. established inflammatory bowel disease 2. age ≥18 years old 3. at inclusion all patients must have a documented active colonic involvement based on either endoscopy or imaging: 4. commencing vedolizumab therapy according to the treating physician or on active therapy up to 6-weeks. 5. active luminal disease: cd- hbi ≥325, 26 uc- partial mayo ≥227 6. evident active disease on endoscopy or imaging within 2-week from inclusion or elevated inflammatory markers at screening (crp\> 0.5 mg/dl, or fecal calprotectin\>100 μgr/gr stool or esr \>40). exclusion criteria: 1. cd- isolated small bowel disease (l1) uc- proctitis (e1) 2. perianal disease 3. pregnancy 4. biliary obstruction 5. concomitant treatment with beta blockers, anti-coagulants, and norfloxacin (relative contra indications to curcumin therapy). 6. curcumin supplementations within the last 6 months.
use of specific genetic alteration s of tumoral cells identified by the next generation sequencing techniques (ngs) to follow peripheral samples of children with metastatic and/or high risk solid tumor - ngskids

Conditions: Metastatic and/or High Risk Solid Tumor of Children

Summary: the search for genetic alterations in primary tumor by ngs techniques followed by the detection of these alterations in circulating tumor dna and/or ctc/dtc present in peripheral samples (blood, cerebrospinal fluid, bone marrow, possibly urine) collected during several steps and after the treatment could be a tool to monitor the response during and after the treatment.


Eligibility criteria:
inclusion criteria: * children with metastatic and/or high risk solid tumor, of the following pathologies : neuroblastoma, sarcoma, malignant brain tumor (medulloblastoma, high-grade glioma), bone tumors, rhabdoid tumors, others rare tumors * availability of a frozen tumoral sample (primary tumor or metastasis whatever the localization) at diagnosis allowing analysis of genetic alterations by a ngs technique * age \< 18 years * signed informed consent by parents or legal representatives * patient having health care insurance exclusion criteria : * age ≥ 18 years * no signed informed consent by parents or legal representatives

Keywords: high risk solid tumor pediatric, genetic alteration, metastatic solid tumor pediatric
peer support impact on therapeutic adherence in patients with multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-remitting

Summary: a mixed methods randomized controlled trial pilot study to assess peer support impact on relapsing-remitting multiple sclerosis patients' therapeutic adherence.

multiple sclerosis (ms) is a debilitating and incurable chronic disease. patients might benefit from peer support provided by patients entitled to give advice on daily life management with ms. studies have shown that peer support can enhance chronic patients' quality of life in psychiatry and oncology. this pilot study aims at assessing the impact of peer support on therapeutic adherence and quality of life in patients with ms, but also to appraise the project feasibility and acceptability among the healthcare team, with large-scale implementation in mind. this mixed methods pilot study consists in a monocentric open-label randomized controlled trial. it is located in nantes, france, and aims to recruit 60 patients with relapsing-remitting ms undergoing drug therapy from the nantes university hospital neurology department. patients will be randomized 1:1 to receive either usual care only or usual care combined with peer support (3 individual sessions at 1, 3 and 5 months with a peer support specialist). primary outcome is enhanced therapeutic adherence 6 months after baseline, secondary outcomes include therapeutic compliance, quality of life, anxiety and depression, social support. all dimensions will be assessed using validated health questionnaires at baseline and at 6 months. interventions acceptability and feasibility will be evaluated using qualitative methods: undirected interviews with patients from the intervention group and 2 focus-groups, one with the peer support specialists and the other with the healthcare team.

Eligibility criteria:
inclusion criteria: * adult patients * with relapsing-remitting ms according to 2017 revised mc donald criteria * attending medical consultation at nantes university hospital neurology department * for whom background drug therapy is needed (oral or injectable) * who gave consent to participate in trial exclusion criteria: * primary-progressive or secondary-progressive ms patients * patients under protection of vulnerable adults measure or convicted * patients not fluent in french * patients with severe cognitive impairment, who may find difficult filling out questionnaires properly * patients with a risk of follow-up interruption (move, nomadism...)

Keywords: multiple sclerosis peer support therapeutic adherence
a study of multiple doses of nusinersen (isis 396443) delivered to infants with genetically diagnosed and presymptomatic spinal muscular atrophy

Conditions: Spinal Muscular Atrophy

Summary: the primary objective of the study is to examine the efficacy of multiple doses of nusinersen administered intrathecally in preventing or delaying the need for respiratory intervention or death in infants with genetically diagnosed and presymptomatic spinal muscular atrophy (sma). secondary objectives of this study are to examine the effects of nusinersen in infants with genetically diagnosed and presymptomatic sma.


Eligibility criteria:
key inclusion criteria: * age ≤ 6 weeks at first dose. * genetic documentation of 5q sma homozygous gene deletion or mutation or compound heterozygous mutation. * genetic documentation of 2 or 3 copies of survival motor neuron 2 (smn2). * ulnar compound muscle action potential (cmap) ≥ 1 mv at baseline. * gestational age of 37 to 42 weeks for singleton births; gestational age of 34 to 42 weeks for twins. * meet additional study related criteria. key exclusion criteria: * hypoxemia (oxygen saturation \<96% awake or asleep without any supplemental oxygen or respiratory support). * any clinical signs or symptoms at screening or immediately prior to the first dosing (day 1) that are, in the opinion of the investigator, strongly suggestive of sma. * clinically significant abnormalities in hematology or clinical chemistry parameters. * treatment with an investigational drug given for the treatment of sma biological agent, or device. any history of gene therapy, prior antisense oligonucleotide (aso) treatment, or cell transplantation. * meet additional study related criteria. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: nurture
safety and efficacy of avapritinib in chinese patients with gastrointestinal stromal tumor (gist) in the real world

Conditions: Gastrointestinal Stromal Tumors

Summary: this study is an observational, multicenter, real-word study to evaluate the safety and clinical efficacy of avapritinib in chinese subjects with gist.


Eligibility criteria:
inclusion criteria: * cohort 1 and 4: participants must have a confirmed diagnosis of unresectable gist with mutations in the pdgfrα gene exon 18. * cohort 2: participants must have a confirmed diagnosis of gist with mutations in the pdgfrα gene exon 18 and was/will be administrated avapritinib in an neoadjuvant and/or adjuvant setting. * cohort 3: participants must have a confirmed diagnosis of unresectable gist without mutations in the pdgfrα gene exon 18, kit gene exon 13, and kit gene exon 14. exclusion criteria: * participants who have participated and may participate in any other interventional clinical trail in the future. * participants with any comorbidities not suitable for avapritinib (other tkis, cohort 4) treatment assessed by researchers.

Keywords: gist avapritinib
left vs. right non-inferiority trial

Conditions: Depression; Major Depressive Disorder; Major Depressive Episode

Summary: the aim of this study is to test the hypothesis that low-frequency rtms (lfr) works as well as the established intermittent thetaburst rtms (itbs) treatment for treatment resistant depression (trd).

in this multi-centre, triple-blinded, non-inferiority trial 420 patients with trd will be recruited at two academic centres (ubc, camh). patients will be randomised to receive either itbs or lfr for 30 sessions. the primary outcome will be the improvement on a depression scale. secondary outcome will be improvement of suicidal ideation. a secondary aim is to test the predictive capacity of a novel, easy to implement heart rate based biomarkers (i.e. heart rate variability).

Eligibility criteria:
inclusion criteria: 1. are female or male; 2. are outpatients; 3. are voluntary and competent to consent to treatment; 4. have a dsm 5 diagnosis of mdd,55 single or recurrent confirmed by mini-international neuropsychiatric interview (mini) version 7.0; 5. are 18yo to 65yo; 6. have failed to achieve a clinical response to an adequate dose of an antidepressant based on an antidepressant treatment history form (athf) score of \> 3 in the current episode or have been unable to tolerate at least two separate trials of antidepressants at less than the minimum adequate dose and/or duration (athf 1 or 2); 7. have a score ≥ 18 on the hamilton depression rating scale (hdrs-17 item); 8. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening; 9. are able to adhere to the treatment schedule; 10. pass the tms and mri adult safety screening questionnaires. exclusion criteria: 1. have a history of substance use within the last 3 months; 2. have a concomitant major unstable medical illness; 3. have active suicidal intent; 4. are pregnant; 5. have a lifetime (mini) diagnosis of any psychotic or bipolar disorder; 6. have a mini anxiety disorder or personality disorder assessed by a study investigator to be primary and causing greater impairment than mdd; 7. have failed a course of ect in the current episode; 8. have any significant neurological disorder, any history of seizure (except those therapeutically induced by ect), significant head trauma with loss of consciousness for \> 5 min; 9. have any intracranial implant (e.g., aneurysm clips) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed; 10. are participating in psychotherapy, must have been in stable treatment for at least 3 months prior to study entry, with no anticipated change in the frequency of therapeutic sessions, or focus of therapeutic sessions over the duration of the study; 11. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators; 12. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview);

Keywords: rtms tms transcranial magnetic stimulation itbs depression major depressive disorder
optimizing the efficiency and implementation of cash transfers to improve adherence to antiretroviral therapy phase ii

Conditions: HIV (Human Immunodeficiency Virus)

Summary: this protocol describes a 2-arm cluster, randomized controlled trial designed to test the effectiveness of a conditional cash transfer on viral suppression at 12 months post-art initiation among phwhiv who have initiated art within the past 30 days. randomization will take place at the clinic level (hiv primary care clinics), and eligible participants attending intervention clinics will have the opportunity to receive up to 6 consecutive monthly cash transfers of 22,500 tsh (\~$10) each, conditional on visit attendance with the hiv care provider. the study will take place at 32 clinics across four regions in tanzania: gaeta, mwanza, kagera and shinyanga. the primary endpoint is viral suppression at 12 months, defined as the proportion of people living with hiv (plhiv) retained in hiv primary care and with suppressed hiv viral load 12 months after starting art.


Eligibility criteria:
inclusion criteria: * greater than or equal to 18 years of age * living with hiv infection * initiated on antiretroviral therapy less than or equal to 1 month prior to enrollment in the study * have access to a mobile phone (ownership, shared ownership, or access to a trusted person's phone) * do not intend to transfer to a different facility for hiv care within the following 12 months. exclusion criteria: -

Keywords: antiretroviral treatment adherence conditional cash transfers tanzania people living with hiv behavioral economics
optima-bp: empowering patients in managing blood pressure

Conditions: Hypertension

Summary: hypertension is the leading modifiable risk factor for cardiovascular disease and is implicated in half of all strokes and myocardial infarctions. one-third of adults in scotland have hypertension yet only one-quarter of these have their blood pressure (bp) controlled to target (\<140/90 mmhg). reasons for the low rate of control are varied but include individuals lack of confidence, knowledge and understanding of the condition and treatment strategy, non-adherence to medication and infrequent bp monitoring. these issues have been compounded by the ongoing covid-19 pandemic which has brought changes in routine bp screening, access to medical care and chronic disease management in primary and secondary care, shielding of the highest risk groups and a change in health and research focus. shared decision making and issues around health literacy were highlighted by the scottish government cross party group on heart disease and stroke: high blood pressure task force in 2019. empowering patients to have a better understanding of their condition and becoming actively involved in the monitoring and management of hypertension may lead to improved patient satisfaction, improved bp control and health outcomes and reduction in the use of primary/secondary care hypertension clinics.


Eligibility criteria:
inclusion criteria: * age ≥18 * current attendance at the gbpc exclusion criteria: * inability to give informed consent * non-english speakers * no internet access * clinic or ambulatory blood pressure ≥180/120 mmhg * arm circumference \>42cm * inability to perform hbpm * inability to use kvatchii portal * pregnancy * persistent atrial fibrillation * acute cardiovascular event requiring hospitalisation in the previous 3 months * ckd stage ≥4 or renal dialysis * severe or terminal illness limiting study participation

Keywords: hypertension home blood pressure monitoring digital health
randomized crossover pharmacokinetic evaluation of subcutaneous versus intravenous granisetron in cancer patients

Conditions: Vomiting

Summary: objective: to evaluate the bioavailability of subcutaneous granisetron.patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. blood and urine samples will be collected after each cycle.

5-ht3 antagonists are one of the mainstays of antiemetic treatment and they are administered either intravenously or orally. nevertheless sometimes neither administration route is feasible, such as in patients unable to admit oral intake managed in an outpatient setting. our objective is to evaluate the bioavailability of subcutaneous granisetron.patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. blood and urine samples will be collected after each cycle. pharmacokinetics of sc and iv granisetron will be prospectively compared.

Eligibility criteria:
inclusion criteria: * cancer patients receiving platinum-based chemotherapy * adequate bone marrow, hepatic and renal function, respectively defined by: platelets \>100000/mm3 and absolute neutrophil count \>1500/mm3; bilirubin, ast and alt \<2 times x upper limit of normality; and creatinine \<1.5 mg/dl. * ecog performance status \<2 and body mass index from 20-28 kg/m2. exclusion criteria: * pregnancy * serious concomitant diseases, in the invesgator´s criteria

Keywords: emesis granisetron pharmacokinetics subcutaneous.
comparison of biomarkers based on fine-needle aspiration in women at increased or normal risk of breast cancer

Conditions: Breast Cancer

Summary: rationale: examining biomarkers in fine-needle aspiration specimens from women at risk for breast cancer may improve the ability to detect breast cancer cells early and plan effective treatment. purpose: screening trial to compare specific biomarkers based on fine-needle aspiration specimens from women at increased or normal risk of breast cancer.

objectives: * compare specific biomarkers, including cellular morphology (cytology), proliferation index (ki-67), p53 expression, and loh in chromosome 9p at locus ds9157, in fine needle aspirate specimens from women at increased vs normal risk of breast cancer. * determine whether these specimens are adequate to perform the biomarker assays and whether this technique could be used in the general outpatient setting. * determine whether biomarker levels in these patients are concordant or discordant with individual clinical risk of breast cancer. * determine whether 1 or more biomarkers can distinguish high-risk from control patients. * correlate specific biomarkers and changes in biomarker levels with pathologic diagnosis from the breast biopsy. outline: patients undergo fine needle aspiration of normal appearing breast tissue prior to the beginning of elective surgery. specimens are analyzed for the presence of specific biomarkers. projected accrual: approximately 156 patients will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: * increased risk of breast cancer as determined by 1 or more first-degree relatives (mother, sister, or daughter) with a history of breast cancer or a personal history of atypical hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ of the breast or * no increased risk of breast cancer as determined by a lack of the above conditions * scheduled to undergo elective breast surgery for removal of a mammographic lesion or palpable breast lump * no prior bilateral mastectomy or bilateral breast irradiation * hormone receptor status: * not specified patient characteristics: age: * 30 and over sex: * female menopausal status: * not specified performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no active invasive malignancy in any site except basal cell or squamous cell skin cancer * no significant medical or psychiatric problems that would preclude study * no evidence of excessive use of narcotics or drug dependency prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * see disease characteristics surgery: * see disease characteristics

Keywords: ductal breast carcinoma in situ lobular breast carcinoma in situ
effects of a protein calorie supplement in hiv-infected women with tuberculosis

Conditions: HIV; Tuberculosis

Summary: the objective of this randomized, controlled trial is to determine if adding a protein-calorie supplement (pcs) to the standard treatments for tuberculosis (tb) and hiv will improve health outcomes. the investigators will enroll 180 hiv-positive women with newly diagnosed active tb and without prior anti-retroviral therapy (art). at baseline, the investigators will conduct dietary interviews, measure body composition, randomize subjects to receive a pcs (plus micronutritional supplements \[mns\]) or control (mns only) for the 6-month duration of anti-tb therapy (att) plus an additional 2 mos (8 mos total). subjects will be followed monthly and have cd4 counts at baseline, 2, 8 and 12 months. at 2 months (i.e., at the end of the 4 drug intensive phase of tb treatment and start of the 2 drug continuation phase), all subjects will be started on anti-retroviral therapy (art) based on tanzanian ministry of health guidelines (currently: azt/3tc/efavirenz). the primary endpoint will be change in cd4 count after 8 months (i.e., at end of pcs/mns intervention and 2 months after completion of att).

the objective of this randomized, controlled trial is to determine if adding a protein-calorie supplement (pcs) to the standard treatments for tuberculosis (tb) and hiv will improve health outcomes. the investigators will enroll 180 hiv-positive women with newly diagnosed active tb and without prior anti-retroviral therapy (art). at baseline, the investigators will conduct dietary interviews, measure body composition, randomize subjects to receive a pcs (plus micronutritional supplements \[mns\]) or control (mns only) for the 6-month duration of anti-tb therapy (att) plus an additional 2 mos (8 mos total). subjects will be followed monthly and have cd4 counts at baseline, 2, 8 and 12 months. at 2 months (i.e., at the end of the 4 drug intensive phase of tb treatment and start of the 2 drug continuation phase), all subjects will be started on anti-retroviral therapy (art) based on tanzanian ministry of health guidelines (currently: azt/3tc/efavirenz). the primary endpoint will be change in cd4 count after 8 months (i.e., at end of pcs/mns intervention and 2 months after completion of att).

Eligibility criteria:
inclusion criteria: * female, * hiv, * age \> 18, * cd4 \> 50, * bmi\>16 * new tb diagnosis, * not on anti-retroviral therapy, * residence in dar es salaam exclusion criteria: * current anti-retroviral therapy, * serious co-morbidities

Keywords: hiv tuberculosis nutrition