Kornimate/medical-research-clean huggingface dataset:
a prospective observational registry of primary headache patients treated with ausanil

Conditions: Primary Headache Disorders

Summary: this study is an observational study with the primary objective to assess the safety and tolerability of ausanil in the treatment of primary headache disorders. the secondary objective is to assess headache pain, functional outcome, time loss to headache and patient satisfaction with ausanil treatment.


Eligibility criteria:
inclusion criteria: * men and women aged 18 to 80 years * primary headache disorder as per international classification of headache disorders-11 * ausanil naive * signed dated informed consent * females of childbearing potential must be using adequate contraception during study period. * willing and able to comply with registry requirements to document headache response exclusion criteria: * known allergy to ausanil or any of its ingredients * active bronchial asthma that in the opinion of the investigator would interfere with use of ausanil * nasal obstruction due to any cause or extensive nasal surgery resulting in scarring or other such impact on nasal mucosa that might lead to heightened sensitivity to ausanil in the opinion of the investigator. * pregnant or breast feeding females * history of addictive behavior * any severe or chronic unstable medical or psychiatric condition * active nasal infection or inflammation * unable or unwilling to provide informed consent * suffer from atypical, basilar or hemiplegic migraine that is new onset or unstable.

Keywords: migraine cluster headache primary headache ausanil capsicum annuum
clinical study to assess the equivalence of tranexamic acid vs oxytocin in reducing the pph

Conditions: Post Partum Haemorrhage

Summary: the purpose of this study was to evaluate that the tranexamic acid (txa)intravenous and oral, is equivalent oxytocin (oxy),intramuscularly, in reducing the blood loss in post partum period (ml) in patients at the end of pregnancy ( 37-42 w ) at low risk of post partum hemorrhage (pph). the pph means a blood loss equal to or greater than 500 ml after a vaginal delivery (the bleeding is defined severe if it exceeds 1000 ml). pph is called "primary" when blood loss arose within 24 hours after birth.

this trial includes three arms of treatment : * arm a (imp1test): txa 500 mg/ 2 vials (1 gr) slow intravenous infusion 1ml/min within 5 minutes from the delivery(third stage af labor) * arm b (imp2control): oxy 5 iu/ml/ 2 vials (10 international unit) intramuscularly within 5 minutes from the delivery (third stage af labor) the clamping of the umbilical cord will be executed immediately after birth. the randomization 1:1 (block design), generated by the computer. primary outcomes: assessment of total blood loss expressed in ml: * immediately after delivery * two hours after delivery the measurement of the overall blood loss at delivery (ml) will be performed by the graduated bag, immediately after birth. the measurement two hours after delivery will be performed by weighing of the adsorbent material \[ n.ml = n. gr indicated by the balance - dry weight of the sanitary napkin\]. the overall loss in blood measured (ml) two hours of delivery will then be performed by adding the two collections.

Eligibility criteria:
inclusion criteria: * subjects at the end of pregnancy ( 37-42 w ) at low risk of pph mean by low-risk of pph subjects without any of the following risk factors : hypertension/preeclampsia, placental abruption during pregnancy , placenta previa , tocolysis two hours before delivery, multiple pregnancy , previous pph, obesity ( bmi \> 35 ), anemia (hb \< 7 g/dl), elective caesarean section , induction of labor, retention of placental material , polyhydramnios , fever during labor, use of high doses of heparin low molecular weight. * subjects full capacity and the willingness to give written informed consent . exclusion criteria: * subjects with preterm pregnancy (\ 42 weeks ) * subjects at the end of pregnancy ( 37 weeks - 42 weeks ) with the following risk factors for pph (tab1.protocol study, vers.2.0 of 07/05/2016) * multiple pregnancy * history of thromboembolic disease or high incidence of thromboembolic events in family history ( patients at high risk of thrombophilia ) * patients with long - qt syndrome or who are taking drugs that cause qt prolongation * intrauterine fetal death * epilepsy * autoimmune disease tab1 medical history : * placental abruption during pregnancy * placenta previa * hypertension / preeclampsia * previous pph * polyhydramnios * obesity ( bmi \> 35 ) * anemia ( \< 7 g / dl )

Keywords: txa pph
hats on head start: a a survey of sun protection behaviors in head start and other early childhood education programs

Conditions: Sunburn

Summary: the proposed study will assess the current sun safety policies and practices in programs for young children and to determine the willingness of stakeholders to incorporate more protective measures. the primary hypothesis is that children in head start programs, daycare programs, elementary schools, or summer camps are exposed to significant uv radiation throughout the day, and are not adequately protected with sunscreen, hats, or sun-protective clothing. the secondary hypothesis is that these programs value sun safety as an important health behavior, but probably do not have the funding avilable to make it a priority.

the study aims are: 1. to assess current exposure to sun and uv in programs of children participating in an early childhood educational program. 2. to assess current policies regarding sun protection and sunscreen use in programs for early childhood education. 3. to assess the current attitudes towards sun safety among caregivers and teachers in programs for early childhood education. 4. to explore association of sun protective behaviors with risk factors such as socioeconomic status, per student classroom budget, program setting (i.e. urban, suburban, or rural), race/ethnicity, size of school program, school budget for supplies, and ages of children enrolled in program. the sample of stakeholders, who will be surveyed, is consistent with samples used in our prior research. a sample size of 250 phone interviews will be adequate to show trends in sun safety policies among early education programs. power analysis is based on the use of sun protection, our primary outcome. our preliminary data show that 15% of schools almost always or always schedule outdoor activities to avoid times when the sun was at peak intensity. the sample size required to sensitively detect a 20% difference in using sun protection between those that comply with recommendations and those that do not is 250 respondents assuming an alpha \ = 0.8 in a two-tailed test on a two-group sample. this sample size will adequately power the study for detecting 30% difference in sun protection use between the two groups.

Eligibility criteria:
inclusion criteria: * someone 18 years of age and older, who is a teacher, administrator, aide, or other staff member of a head start program, day care program, camp, or elementary school. * participants agree to a structured phone interview regarding their program's policies for sun safety, their opinions on certain health behaviors, and the demographics of their student population. * participants will be interviewed on the phone and guided through a questionnaire which should take approximately 10 minutes to complete. exclusion criteria: * participants who do not know their program's procedures for sun protection will not be able to participate, but may transfer the phone call to another colleague who can answer the questions accurately. participants without the ability to speak in english will be excluded from the study.

Keywords: sunscreen
bortezomib in treating patients with recurrent glioma

Conditions: Adult Anaplastic Astrocytoma; Adult Anaplastic Oligodendroglioma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor

Summary: phase i trial to study the effectiveness of bortezomib in treating patients who have recurrent glioma. bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth

objectives: i. determine the maximum tolerated dose of bortezomib with or without anticonvulsant drugs known to be metabolized by the p450 hepatic enzyme complex in patients with recurrent glioma. ii. determine the biologic activity of this drug by measuring proteasome 20s activity in these patients. iii. determine the effects of hepatic enzyme-inducing drugs, such as anticonvulsants, on biologic activity of this drug in these patients. outline: this is a dose-escalation, multicenter study. patients are stratified according to concurrent anticonvulsant drug use (phenytoin, carbamazepine, phenobarbital, primidone, or felbamate vs gabapentin, lamotrigine, valproic acid, or no anticonvulsant drugs). patients receive bortezomib iv over 3-5 seconds twice weekly for 2 weeks. courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. once the mtd is determined, 10 additional patients are treated with bortezomib at the mtd. patients are followed every 2 months.

Eligibility criteria:
inclusion criteria: * histologically confirmed progressive or recurrent malignant glioma * anaplastic astrocytoma * anaplastic oligodendroglioma * glioblastoma multiforme * prior low-grade gliomas that have progressed to high-grade after therapy allowed * measurable disease by mri or ct scan * performance status - karnofsky 60-100% * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * bilirubin no greater than 1.5 mg/dl * transaminases no greater than 4 times upper limit of normal * creatinine no greater than 1.7 mg/dl * mini mental score at least 15 * no concurrent serious infection or other medical illness that would preclude study participation * no other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 3 months after study participation * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * no more than 1 prior chemotherapy regimen * at least 3 months since prior radiotherapy and recovered * no other concurrent investigational agents
individualized pneumoperitoneum pressure in colorectal laparoscopic surgery versus standard therapy (ippcollapse-ii)

Conditions: Colorectal Surgery; Laparoscopy

Summary: the purpose of this study is to assess the post-operative recovery quality of the individualized pneumoperitoneum pressure therapy in colorectal laparoscopic surgery versus standard therapy using a quality validated scale of postoperative recovery of their stay in the post-anaesthesia recovery unit.

in the last two decades laparoscopic surgery has settled as a less invasive surgical approach compared to open surgery. it is associated with lower perioperative morbidity and hospital stay. there is growing evidence that increased intra-abdominal pressure (iap), even for short periods of time, is associated with increased perioperative morbidity (pain, increased inflammatory markers peritoneal injury worse splanchnic perfusion abnormalities hemodynamic and ventilatory ...). the study is a prospective multicenter randomized clinical intervention trial to assess the impact of iap individualization strategy (ipp-individualized pneumoperitoneum pressure) relative to a iap standard strategy (spp-standard pneumoperitoneum pressure) using a validated scale (vas) (pqrs- postoperative quality of recovery scale). postoperative pain in the first 24 hours (area under vas curve , opioid rescue, referred pain to the shoulder) and surgical stress and inflammatory markers (neutrophil/lymphocyte, ratio,c-reactive protein, interleukin-6, procalcitonin) are also measured. postoperative complications are evaluated by clavier-dindo classification.

Eligibility criteria:
inclusion criteria: * patients older than 18 years * classification of the american society of anesthesiologists (asa i-iii) * no cognitive deficits * signed informed consent prior to surgery exclusion criteria: * emergency surgery * pregnancy or lactation * immune disorders * kidney or liver disease or advanced-stage cardiopulmonary * patient refusal to participate in the study * patients under 18 years or inability to consent * associated neuromuscular disorders, contraindication for the use of rocuronium/ sugammadex, allergy or hypersensitivity to rocuronium / sugammadex

Keywords: colorectal laparoscopic surgery
prospective, randomized, multi-center comparative study on topical probiotics in diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: looking at the efficacy of using probiotics in soyabean concentrate in the management of diabetic lower extremity ulcers when administered by a wider variety of clinicians at multiple locations with a more heterogeneous patient

diabetic foot ulcers and pressure injury wounds are still a very common problem. according to international diabetic federation (idf) around 12-15% of the general diabetic patient with develops a diabetic foot ulcer. these ulcers if not properly treated and managed can lead to major limb amputation. the 5-year survival rate according to our own previous study is around 67%. the management of the diabetic foot ulcer is at present being met using advanced wound care and surgical debridement and reconstruction. probiotics has recently being discussed as an effective form of management for these chronic wounds. probiotics exert their positive effects through multiple mechanisms including: (a) competition with pathogenic bacteria for nutrients and binding sites on the host cell; (b) inactivation of toxins and metabolites, (c) production of antimicrobial substances that inhibit the growth of pathogenic microorganisms, and (d) stimulation/modulation of host immune response. probiotic-host interactions involving epithelial cells (ec), dendritic cells (dc), and regulatory t lymphocytes have also been well studied particularly in the gi tract. this study looks at the efficacy of using probiotics in soyabean concentrate in the management of diabetic lower extremity ulcers when administered by a wider variety of clinicians at multiple locations with a more heterogeneous patient

Eligibility criteria:
inclusion criteria: * age 20 or older type 1 or type 2 diabetes able and willing to provide consent and agrees to comply with study procedures and follow-up evaluations ulcer size 1cm2 and \< 25cm2 ulcer duration of 4 weeks, unresponsive to standard wound care serum creatinine \<3.0 mg/dl hba1c \<12% no clinical peripheral arterial occlusive disease. able to carry out the wound care as described in the study exclusion criteria: * current participation in another clinical trial ulcer with exposure of tendon or bone severely infected wound currently under radio or chemotherapy known or suspected malignancy of current ulcer use of biomedical/topical growth factor within previous 30 days pregnant or breast feeding taking medications considered to be immune system modulators allergy to known sensitivity to probiotics of soyabean. inability to carry out wound care as described in the study. inability to sign an informed consent form

Keywords: probiotics soybean concentrate
prevalence, persistence, and risk factors for oral human papillomavirus (hpv) infections in college women

Conditions: Human Papillomavirus

Summary: the purpose of this study is to determine how common oral hpv infections are in college women. the investigators also will find out what risk factors are associated with having oral hpv infections. the investigators hypothesize that approximately 3% of women will have oral hpv, and that hpv will be associated with oral sexual behaviors and with smoking behaviors. finally, for those women with oral hpv- the investigators will determine whether the infections are persistent (still present) at 3-, 6-, and 12-months after the initial diagnosis.


Eligibility criteria:
inclusion criteria: * age \>=18 years * female * currently enrolled as a college student exclusion criteria: * unable to provide an oral rinse sample * unable to complete survey * unable to provide contact information * already completed study.
clinical, histological and prognostic forms of adenocarcinoma of the anus

Conditions: Anal Adenocarcinoma

Summary: adenocarcinoma of the anus is rare. it concerns less than 10% of anal cancers and its incidence is less than 0.2/100 000 inhabitants. its management is not consensual and is most often derived by analogy with that of adenocarcinoma of the lower rectum. this is due to the rarity but also to the diversity of anatomical (anal margin, anal canal, lower rectum), etiological (primary glandular tumors or secondary to anal fistula, primary distant tumor and/or crohn's disease) and histological forms (mucinous, intestinal, glandular adenocarcinomas and primary or secondary paget's disease). most of the literature consists of small case series and simple clinical cases in which the prognosis of these subforms has not been studied.


Eligibility criteria:
inclusion criteria: * patient over 18 years of age * french-speaking patient * patient with a diagnosis of adenocarcinoma of the anus between 01/01/2006 and 30/06/2022 in participating centers exclusion criteria: * patient under guardianship or curatorship * patient deprived of liberty * patient under court protection * patient objecting to the use of his data for this research
incentives targeting gestational weight gain in overweight/obese low income women

Conditions: Overweight; Obesity; Pregnancy

Summary: excessive weight gain during pregnancy, particularly in overweight and obese women, predisposes to adverse perinatal outcomes and has long term effects on maternal and neonatal health. with an inverse relationship between socioeconomic status and obesity, significant health disparities exist between obese and normal weight women. the institute of medicine (iom) recently revised its gestational weight gain recommendations, targeted to pregravid body mass index (bmi), to minimize pregnancy complications. however, these recommendations are based on cross sectional observational studies and neither the ideal method to achieve weight gain goals nor whether perinatal outcome is optimized with active management of weight gain is known. the investigators propose to investigate a behavioral incentive-based intervention to improve compliance with iom weight gain recommendations during pregnancy in low-income overweight and obese women. the investigators will evaluate if 1) gestational weight gain can be reliably targeted to the iom recommendations and 2) active weight gain management during pregnancy improves perinatal outcomes. two study groups will be compared in a prospective randomized trial; 1) those receiving standard obstetrical care and 2) those receiving behavioral weight management counseling plus financial incentives for achieving weight gain goals. the main outcome measure will be the percentage of women gaining within the iom recommendations based on prepregnancy bmi. secondary outcomes evaluated will include fetal growth and body composition changes, birth weight and the rate of cesarean delivery. the investigators hypothesize that 1) the behavioral intervention with incentives will result in greater compliance to iom guidelines for gestational weight gain than standard care and 2) targeting weight gain to the iom guidelines will lead to a reduction in the rates of fetal macrosomia and cesarean delivery. finally, cost effectiveness of treatment conditions will be examined. this intervention, if efficacious and cost-effective, has the potential to improve compliance with gestational weight gain guidelines, optimize perinatal outcomes, and reduce health disparities.


Eligibility criteria:
inclusion criteria: -≥18 years of age and ≤ 45 years of age -≤16 weeks gestation * bmi ≥25 * ultrasound documented viable singleton intrauterine pregnancy * english speaking * planning to deliver at fletcher allen health care * willing to be randomized to one of the study groups * written informed consent exclusion criteria: * major fetal congenital or chromosomal anomaly * women with a restricted diet (i.e., celiac disease, prior bariatric surgery, phenylketonuria, or other metabolic disorder)

Keywords: obesity pregnancy
study in participants with acute migraines headaches

Conditions: Migraine Headache

Summary: this is a phase 2, multicenter, randomized, double-blind, placebo and active comparator-controlled study of ly2590443 in approximately 200 participants with migraines.


Eligibility criteria:
inclusion criteria: * male and female participants between the ages of 18 and 65 years, inclusive. * participants who have migraine headaches, with or without aura (diagnosis according the international classification of headache disorders-ii), for at least 1 year. * participants who have had 2-8 migraine attacks on average per month for the last 3 months (but less than 15 headache days per month). * participants who are willing and able to comply with the study schedule and requirements. * participants who speak, read, and understand english sufficiently well and are willing to provide written informed consent. * participants who in the opinion of the principal investigator are in good general health. * venous access should be sufficient to allow blood sampling as per protocol. exclusion criteria: * participants who do not or may not tolerate 5ht1 agonist treatments, with known hypersensitivity to sumatriptan (as discussed with the investigator). * female participants who have a positive pregnancy test at screening or pre- dose evaluation, or are breastfeeding. * history or presence of significant medical illnesses as determined by the investigator. * participants with a current clinical diagnosis of major psychiatric disease. * regular use of known drugs of abuse; use of opiates for migraine rescue (no more than two times per month) is permissible. * blood donation of 500 milliliter (ml) or greater of whole blood products within 4 weeks of study commencement, during the study, or 4 weeks following the study. * investigator site personnel directly affiliated with this study and their immediate families. immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. * consumption of more than three units of alcohol per day where one unit is defined as a 12 ounces (oz) beer, 4 oz wine, or 2 oz of alcohol spirit liquor. * are unwilling or unable to comply with the use of a diary to directly record data from the participant.

Keywords: migraine headache