Kornimate/medical-research-clean huggingface dataset:
relationship between gestational diabetes mellitus and inflammatory adipocytokins in obese mothers and their newborn at delivery

Conditions: Diabetes, Gestational

Summary: adipogest study aims at comparing circulating levels of inflammatory adipocytokins and c-reactive protein in obese women and their newborn at delivery whether exposed or not to gestational diabetes mellitus (gdm)

adipogest is a cross sectional study in which mothers are divided into 2 groups : exposed and unexposed to gdm, matched on pregestational bmi, date of delivery and child gender. mothers are recruited in the maternity ward of the university hospital in south of reunion island. it is planned a conveniance sample of 20 mother-child pairs per group.

Eligibility criteria:
inclusion criteria: * pregnant women * obese women (bmi : 30 kg/m² or more) * aged over 18 years * with single pregnancy * with alive newborn at 37 weeks of amenorrhea or more * with informed consent exclusion criteria: * smoker * treatments by corticoïds or thyroid hormons * overt diabetes * complicated pregnancy * premature delivery threat

Keywords: gestational diabetes mellitus obesity adipocytokin
specialized physiotherapy program for cervical dystonia

Conditions: Cervical Dystonia

Summary: the investigators wish to establish on a small scale the effectiveness of adding the physiotherapy programme developed by jean-pierre bleton to the present standard treatment for cervical dystonia with a view to undertaking a larger uk-wide trial looking at overall cost-effectiveness. specifically, the investigators wish to establish: 1. whether this specific physiotherapy program for cervical dystonia improves patient outcomes in terms of neck position, pain, disability, and quality of life compared to simple physiotherapy advice? 2. what is the minimal clinically important change in the new cdip-58 quality of life measure for cervical dystonia from a patient's perspective that could then be used to plan a definitive trial of this technique? 3. what are the economic implications of the specialized physiotherapy programme?


Eligibility criteria:
inclusion criteria: all the following inclusion criteria must be met: 1. any person over 16 years with primary cervical dystonia causing sufficient interference in lifestyle that they wish to consider physiotherapy treatment and who is able to give informed consent. 2. an abnormal neck position (toronto western spasmodic torticollis rating scale \[twstr\] part 1a \> 0). 3. patients receiving treatment with botulinum toxin (type a or b) injections (as most will) provided they are on a stable botulinum toxin regimen (i.e. same dose and injection pattern over the previous two injections). this includes those newly diagnosed patients who choose to have botulinum toxin injections or patients not receiving botulinum toxin (either because of patient preference or previous lack of effect) provided they plan to remain off botulinum toxin for the one year duration of the trial. there will probably be few of these patients but we feel justified in including them because there are no other treatments on offer and because it is presently unknown whether physiotherapy requires botulinum toxin to weaken the muscles in order to have an effect. anecdotal reports suggest that it can be effective even without botulinum toxin. however, the small numbers who are not receiving botulinum toxin will be analysed as a separate subgroup initially to check whether their response is significantly different to those receiving botulinum toxin. exclusion criteria: patients with any of the following criteria will be excluded: 1. secondary cervical dystonia (e.g. acute onset following trauma or secondary to drugs) 2. a fixed cervical dystonia which may imply a psychogenic component. 3. radicular or myelopathic features where cervical manipulation may be dangerous. 4. patients known to have fused cervical vertebrae from previous x-rays 5. previous use of the bleton technique. 6. deep brain stimulation for cervical dystonia. 7. dementia. 8. unable to comply with visits for physiotherapy and assessment.
safety and efficacy study of lymphostat-b (belimumab) in subjects with systemic lupus erythematosus (sle)

Conditions: Lupus Erythematosus, Systemic

Summary: the purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active sle disease.

the purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with active sle disease. patients were randomly assigned, following stratification by the screening selena sledai score (4 to 7 versus ≥ 8), to 1 of the 4 study arms (3 active arms and 1 placebo arm plus standard therapy for sle). all patients were to be dosed on days 0, 14, and 28, then every 28 days for the remainder of 52 weeks. patients completing the 52-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.

Eligibility criteria:
primary inclusion criteria * clinical diagnosis of sle * "active" sle disease * on a stable sle treatment regimen * history of measurable autoantibodies primary exclusion criteria * received a non-fda approved investigational agent within last 28 days * cyclosporin, intravenous immunoglobulin (ivig) or plasmapheresis within last 90 days * active lupus nephritis requiring hemodialysis, cyclophosphamide (cytoxan™), or high-dose prednisone (\> 100 mg/day) within last 90 days * active central nervous system (cns) lupus requiring therapeutic intervention within last 60 days * history of renal transplant * history of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days * history of hypogammaglobulinemia or immunoglobulin a (iga) deficiency * human immunodeficiency virus (hiv), hepatitis b, hepatitis c

Keywords: sle
monitoring to the evolution of motor function in sma type ii adults patients treated with spinraza®

Conditions: Spinal Muscular Atrophy

Summary: spinraza® (nusinersen) is the first intrathecal administered drug which was approved by the fda to treat sma children and adults (2016). the aim is to monitor the evolution of the motor function measure-32 for sma type ii adult patients treated with spinraza® (nusinersen).


Eligibility criteria:
inclusion criteria: * adult patients with sma type ii disease who are wheelchair bound, * must be 18 years or older, * men or women with sma type ii disease (age at symptoms onset: \>6 months old and who never acquired the capacity to walk but acquired the ability to sit without support) with genetic confirmed diagnosis of 5q sma homozygous gene deletion (smn1 exon 7/8) or mutation or compound heterozygous mutation - performed by pcr amplification and restriction digest of dna using primers flanking smn1 and smn2 exon 7. * mfm 32 score ≥ 19/96 * lumbar ct scan showing the feasibility of intrathecal injection. * written informed consent from the subject prior to initiation of any study-mandated procedures * females of childbearing potential must have a negative pregnancy test at screening and at enrollment, must agree to use reliable method of contraception (if sexually active) from screening up to study drug discontinuation plus 180 days. exclusion criteria: * patients with a high risk for thrombocytopenia or hemorrhage or renal diseases: urine protein, platelet count and coagulation tests will be done prior to intrathecal injection with spinraza® * patients with high risk of hydrocephalus * adult patients under guardianship * pregnant and/or breastfeeding females * subject has received any investigational therapy or pharmacological treatment for sma one month prior the beginning of the study * subject has received gene therapy for sma
the preliminary effects of henna on cipn

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: chemotherapy-induced peripheral neuropathy (cipn) is one of the most common long-term toxicities of chemotherapy. though, cipn is one of the common symptoms encountered by oncology nurses in care of patients. for this reason, there is a need for an intervention that could decrease or prevent of cipn.

chemotherapy-induced peripheral neuropathy (cipn) is frequently seen in patients receiving oxaliplatin-based therapy.this parallel group randomized controlled pilot clinical trial aimed at investigating the feasibility and preliminary effect of henna on cipn in women receiving oxaliplatin-based therapy. this trial was conducted in the chemotherapy outpatient clinic of university hospital located in turkey. all patients were women who received oxaliplatin-based therapy in the oncology clinic every fifteen days. in order to calculate the sample size, it was decided to recruit 30 female patients to each group (intervention and control) using the g.power-3.1.9.2 program. a total of 60 female patients were included in the study. the study consists of two groups. in the intervention group, after the 2nd and 3rd chemotherapy cycles, henna application was applied to the hand-foot and toes. the control group underwent only the routine treatment. to collect data, a personal information form and chemotherapy-induced peripheral neuropathy assessment tool (cipnat) were used.

Eligibility criteria:
inclusion criteria: * 18 years and older women * must the level of neurotoxicity is stage ii and stage iii * must taken at least one chemotherapy cycle and is planned to continue 2 chemotherapy cycles * be taking folfox-6 chemotherapy protocol exclusion criteria: * having an open wound and edema in the hands and feet * having a peripheral neuropathy due to diabetes and autoimmune diseases * using any complementary and alternative (cam) treatment method to prevent peripheral neuropathy during administration

Keywords: chemotherapy-induced peripheral neuropathy henna nursing
is vitamin d insufficiency and deficiency associated with antepartum and postpartum depression?

Conditions: Depression; Postpartum Depression

Summary: our primary aim is to evaluate whether vitamin d deficiency causes depressive symptoms in antepartum and postpartum depression and whether early correction of vitamin d deficiency improves these symptoms. our secondary aims evaluate maternal and fetal outcomes including antepartum, intrapartum, and immediate postpartum complications. we are also evaluating the effectiveness of a common vitamin d treatment regimen used outside of pregnancy.

our study recruitment will be at a single center in our pregnant private and clinic population. we will recruit eligible pregnant women 20 weeks 0 days or less. on study entry, patients will complete a demographic survey, vitamin d exposure survey, and an edinburgh postnatal depression score (epds) questionnaire. baseline vitamin d levels will be obtained using a 25 oh d (vitamin d) assay. women found to be vitamin d deficient/insufficient will be approached for randomization to vitamin d3 (cholecalciferol) 50,000 iu/week x 8 weeks + prenatal vitamin versus placebo + prenatal vitamin. a repeat 25 oh d sample plus a vitamin d exposure and epds questionnaires will be obtained between 24-28 weeks gestation upon completing treatment. all patients will then be kept on maintenance vitamin d until delivery (total vitamin d 800iu/day which includes prenatal vitamin). delivery 25 oh d samples will be collected on all women. at delivery, these women will also complete vitamin d exposure and epds questionnaires. maternal and fetal outcome data will be collected on all patients. as for vitamin d sufficient patients, they will be followed with vitamin d exposure and epds questionnaires at 24-28 weeks and delivery. a 25 oh d sample will be obtained at delivery for these women. maternal and fetal outcome data will be obtained. for vitamin d deficient women declining randomization, they will be given vitamin d repletion based on their preference after counseling. we will continue to follow their questionnaires and outcomes similarly to the vitamin d sufficient group.

Eligibility criteria:
inclusion criteria: * evaluation at roosevelt hospital (receiving prenatal care with st luke's roosevelt hospital center private physicians and clinic) by 20w0d gestation. * planned delivery at roosevelt hospital labor \& delivery * english or spanish speaking exclusion criteria: * non-english or non-spanish speaking * currently on anti-depressants/mood stabilizing medications * medical comorbidities affecting vitamin d absorption or metabolism:bone disease (osteoporosis, osteomalacia); malabsorption disorders (cystic fibrosis, inflammatory bowel disease, roux-en-y bariatric surgery); chronic kidney disease; severe liver disease; granuloma forming disorders (active tuberculosis, sarcoidosis);parathyroid disease; lymphoma; hiv on haart medication; anti-seizure medications.
antibiotics for postpartum third and fourth degree perineal tear repairs

Conditions: Pregnancy Complications, Infectious

Summary: this study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.

after obtaining consent patients who sustained third or fourth degree perineal laceration after vaginal delivery were randomly assigned to a single dose of antibiotic (cefotetan or cefoxitin, 1 g intravenously or clindamycin, 900 mg intravenously, if allergic to penicillin), or placebo (100ml normal saline) intravenously.

Eligibility criteria:
inclusion criteria: - third and fourth degree perineal laceration exclusion criteria: - chorioamnionitis, hiv positive, inflammatory bowel disease
nivolumab and ipilimumab in t1an0m0 renal cell carcinoma patients ineligible for surgical treatment.

Conditions: Renal Cell Carcinoma

Summary: the aim of this phase 2 study is to evaluate the efficacy and safety of nivolumab, an anti-pd-1 antibody, and ipilimumab, an anti-ctla-4 antibody, in t1an0m0 clear-cell rcc patients ineligible for surgical treatment.

surgery remains the standard curative-intent therapy for localized renal cell carcinoma (rcc). thus, systemic therapy for rcc should still be considered only in patients who have contraindications to surgery. results of phase 3 checkmate 214 study showed that a combination of nivolumab and ipilimumab has a significant impact on tumor burden in intermediate- and poor-risk metastatic rcc patients with a complete response rate of 11% (motzer et al. lancet oncology 2019). median time to objective response was 2.8 months. among all complete responders to nivolumab plus ipilimumab in the intention-to-treat population, 5% achieved a complete response at the first scan, whereas most converted from the partial response at a median of 6.9 months or from the stable disease at a median of 11.3 months. we hypothesize that this combination could completely eliminate primary tumors in patients with small primary (less than 4 cm) ineligible for surgical treatment. there are no studies evaluating checkpoint inhibitors in this setting in rcc patients.

Eligibility criteria:
inclusion criteria: 1. cytologically proven clear-cell rcc 2. ct-confirmed measurable primary tumor less than 4 cm and no evidence of extranodal metastatic disease (t1an0m0) 3. inability to perform surgery for any reason (functional single kidney with a central, high-complexity rcc, high risk of nephrectomy and dialysis, patients with complex coagulation disorders, etc.) or preference of patient is to have no surgery for any reason 4. no contradictions to nivolumab and ipilimumab 5. age 18 or older 6. written informed consent exclusion criteria: 1. prior treatment for rcc 2. pregnant or nursing 3. history of serious hypertension, cardiac arrhythmia, congestive heart failure, angina pectoris, or another severe cardiovascular disease (i.e., new york heart association class iii or iv) 4. evidence of metastatic disease 5. local and/or systemic infections requiring antibiotics within 28 days prior to study entry 6. other malignancy
genetic polymorphisms of abcb11 and abcb4 in women with intrahepatic cholestasis of pregnancy (icp) and in their first degree relatives

Conditions: Cholestasis of Pregnancy

Summary: to assess the occurrence of 11 snp's in abcb11 and abcb4 genes in greek women with icp compared with healthy pregnant women. moreover, these genetic polymorphisms will be examined in their first-degree relatives.

introduction: icp is commolnly manifested in the 2nd and especially in the 3rd trimester of pregnancy. pathogenesis of icp is multifactorial implicating genetic, environmental and hormonologic factors. prevalence of icp varies. in certain populations in latin america occurrence of icp is up to 15% of pregnancies. in caucasian populations incidence of icp is approximately 1% of pregnancies. data for the greek population are scarce. genes abcb4 and abcb11 that are encoding transport proteins in the hepatocyte are implicated in the pathogenesis of icp. aim of the study: to study the genetic polymorphisms in pregnant women with icp and in their first degree relatives patients and methods: to recruit 100 women with icp. analyze the occurrence of 11 snp's in abcb11 and abcb4 genes in women with icp. as control group will be used pregnant women without icp or known hepatic disease. in these women the same analysis for snp's as in women with icp will be performed. exclusion criteria: women with known hepatic disease ( hbv, hcv, hiv, hev, autoimmune hepatitis, drug induced liver injury, cirrhosis) and women with pregnancy related liver disease (pre-eclampsia, acute fatty liver of pregnancy or hellp syndrome) inclusion criteria: pregnant women with icp. detailed report of medical history, laboratory and clinical data regarding women and the pregnancy. follow up of laboratory values before and after the begging of treatment with udca.

Eligibility criteria:
inclusion criteria: * pregnant women with icp exclusion criteria: * women with known hepatic disease ( hbv, hcv, hiv, hev, autoimmune hepatitis, drug induced liver injury, cirrhosis) * women with pregnancy related liver disease (pre-eclampsia, acute fatty liver of pregnancy or hellp syndrome)
sphenopalatine ganglion block for headache after concussion

Conditions: Concussion; Headache

Summary: this clinical trial will enroll participants to evaluate the effects of spg block on post-traumatic headache. the study hypothesizes that patients that receive a spg block with lidocaine vs. placebo (saline) will have a lower number of headache days in the week following the procedure, and will also report lower symptom scores. eligible participants will receive one treatment (spg block) as well as complete surveys prior to and after receiving treatment (for a total of approximately 2 weeks).


Eligibility criteria:
inclusion criteria: * diagnosed with a concussion and are greater than 14 days from the date of their injury. * experiencing greater or equal than 4 occurrences of headache per week lasting at least 1 hour per occurrence with a headache severity score greater or equal to 2 out of 6. exclusion criteria: * allergy to local anesthetics of the amide type (for example (i.e.) lidocaine) * frequent epistaxis (i.e. more than one nose bleed per month), * bleeding disorders * history of any of the following: nasal or facial fracture, nasal septal defect, any other craniofacial abnormality, hepatic disease, adam-stokes syndrome, wolff-parkinson-white syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular heart block * pregnant * are at increased risk for methemoglobinemia (including patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, and concurrent exposure to oxidizing agents or their metabolites and drugs associated with methemoglobinemia)

Keywords: concussions headaches sphenopalatine ganglion block
microvascular injury and blood-brain barrier dysfunction as novel biomarkers and targets for treatment in traumatic brain injury

Conditions: Traumatic Brain Injury; Blood Brain Barrier Defect

Summary: traumatic brain injury (tbi) is a leading cause of death and disability around the world. the social and economic burden of tbi is tremendous and the cost of tbi is estimated at $1 billion per year in canada- $650 million in care and $580 million in lost productivity. novel interventions aimed at tbi-linked molecular targets have been successful in limiting injury and improving neurologic recovery in animal models, thus providing compelling evidence that effective intervention is possible after injury. this study proposes to investigate traumatic microvascular injury (tmi) and specifically blood-brain barrier dysfunction (bbbd) as a candidate biomarker and therapeutic target in tbi.


Eligibility criteria:
inclusion criteria: * age 18 - 85 inclusive * clinically diagnosed tbi or evidence of tbi * for mild tbi, as defined by the american congress on rehabilitation medicine (1993), clear evidence and/or documentation of blunt head injury and any one of the following: * any loss of consciousness up to 30 min * any loss of memory for events immediately before or after the injury as much as 24 h * any alteration of mental state at the time of the injury * focal neurologic deficits that might or might not be transient but where the severity of the injury does not exceed oss of consciousness exceeding 30 min, posttraumatic amnesia longer than 24 h, a glasgow coma scale score falling below 13 after 30 min. * for moderate tbi (gcs 9-12) and severe tbi (gcs 4-8) ct evidence of tbi-linked abnormality (intracranial lesion including traumatic sah, contusion, extra-axial hematoma). for patients who are intubated, use best documented gcs within first 48 hours of injury. * stable respiratory or hemodynamic status allowing mri within 2-4 days of tbi as determined by the attending physician * patient or substitute decision maker can provide consent exclusion criteria: * pre-existing known neurologic, psychiatric disease (dementia, prior severe tbi, schizophrenia, uncontrolled epilepsy, major depressive disorder, stroke, multiple sclerosis, brain tumor) * serious infection, complications (sepsis, multilobe pneumonia, etc.) \< 4 days after tbi * acute ischemic heart disease (mi or unstable angina) * sbp \< 100 mm hg, dbp \< 60 mm hg * mri contraindications; patient has metal implant, pacemaker, biostimulator, neurostimulator, internal defibrillator, history of metal in eye, inner ear implant, cerebral aneurism clip, joint replacement, any known metal in their body, or are pregnant or breast feeding * history or evidence of active malignancy * history or evidence of serious kidney (gfr =\<60) , heart, or liver disease * pregnant or breast-feeding women * inability to complete follow up visits (e.g. tourists)