Kornimate/medical-research-clean huggingface dataset:
a long-term safety trial of lum-201 in children with idiopathic growth hormone deficiency who have previously completed a lum-201 clinical trial (oragrowth211)

Conditions: Growth Hormone Deficiency

Summary: this is a multi-national trial. the trial aims to study the long-term safety of lum-201 in subjects with idiopathic pediatric growth hormone deficiency (ipghd). this study will also assess pharmacodynamics and efficacy response to therapy with lum-201.

an extension study to monitor long-term safety of lum-201 treatment in children with idiopathic growth hormone deficiency. this study will last for up to 36 months to allow collection of additional long-term safety and efficacy data related to lum-201 treatment in the pediatric patient population. subjects will enter into this trial after successful participation in a prior lum-201 study. this study will consist of visits every 6 months through three years. there are a total of 7 in-person visits with a follow-up phone call between visits. at the clinic visits, subjects will have a physical exam and blood collection as well as efficacy assessments.

Eligibility criteria:
inclusion criteria: * parent/caregiver must sign the informed consent, and the subject must sign the assent, as applicable. * must have successfully participated in a pediatric lum-201 ghd study through at least the 12-month visit, and be eligible for continuation of treatment, pending all other enrollment criteria are met. exclusion criteria: * medical or genetic condition that, in the opinion of the pi and/or mms, adds unwarranted risk to the use of lum-201 * has planned or is receiving current long-term treatment with medications known to act as substrates, inducers, or inhibitors of the cytochrome system cyp3a4 that metabolizes lum-201. subjects receiving shorter-term (two weeks or less) treatment with these medications should be evaluated on case-by-case basis by the pi in consultation with the mms.

Keywords: lum-201 pghd ghd growth hormone secretagogue oral height
buprenorphine/naloxone in the treatment of heroin dependence - 14

Conditions: Opioid Dependence; Substance-Related Disorders

Summary: the purpose of this study is the safety and efficacy of buprenorphine/naloxone in the treatment of opioid dependence. a compassionate use study.

the objective of this study is to provide follow-up compassionate use treatment and evaluate long term safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment for subjects who have completed cooperative study 1008 a and b.

Eligibility criteria:
inclusion criteria: - completion of cooperative study 1008 a/b exclusion criteria: - significant medical or psychiatric illness. non-compliance with study procedures in the cooperative study 1008 a/b

Keywords: opioid dependence
a comparison of three methods of hemoglobin monitoring in pediatric patients

Conditions: Child

Summary: investigators compare the accuracy of the sphb and hemocue with blood hb levels

the goal of the study is to compare 3 methods of hemoglobin measurement in pediatric patients undergoing major surgery. during general anesthesia investigators will measure and compare at different periods of time blood hemoglobin levels obtained from a radial artery catheter with 2 non invasive methods of measurement using hemocue and sphb

Eligibility criteria:
inclusion criteria: * paediatric patients scheduled for surgery under general anesthesia * arterial catheter necessary in the anesthetic protocol * bmi\<30 * written consent of holders of parental authority * no opposition of children exclusion criteria: - hemoglobine disease

Keywords: major pediatric surgery hemoglobin measurement
the effect of delivery mode on inter - couple relationship, sexual function and pelvic floor activity

Conditions: Pregnancy

Summary: pregnancy and delivery have a major impact on couple's inter personal relationship. different modes of delivery have different effect on pelvic floor function, and it is known that instrumental vaginal deliveries have the worse effect, though various common anatomical injuries have been described following vaginal delivery. pelvic floor dysfunction has the potential to ameliorate sexual function, and the investigators hypothesis is that the impact of delivery on pelvic floor disorders following delivery will have a direct effect on sexual malfunction and interpersonal relationship. the purpose of this study is to evaluate the effect of delivery mode of primiparous women on inter couple relationship , their sexual function and the female pelvic floor activity. the couples will be followed from the second trimester of the pregnancy by validated specific questionnaires, assessing the couple's satisfaction of their marriage, intimacy in their relationship, their sexual behavior and pelvic floor function. after delivery, the parameters of the parturition will be recorded, and the couples will be interviewed 6 months following delivery. apart from questionnaires, sample of the participated women will be assessed by ultrasound examination of the pelvic floor.

pregnant women in their first pregnancy and their husbands will be recruited from 14th week of gestation. the couples will be followed by validated specific questionnaires, such as couple satisfaction index (csi), isreali sexual behavior inventory (isbi), pelvic floor distress inventory (pfdi)and pelvic floor impact questionnaire (pfiq) assessing the couple's satisfaction of their marriage, intimacy in their relationship, their sexual behavior and pelvic floor function. after delivery, the parameters of the parturition will be recorded, and the couples will be interviewed 6 months following delivery. apart from questionnaires, sample of the participated women will be assessed by ultrasound examination of the pelvic floor, demonstrating the continuity of pelvic floor muscles and their function.

Eligibility criteria:
inclusion criteria: * pregnant women in their 1st pregnancy * married couples in their 1st marriage exclusion criteria: * chronic git disease * endometriosis * chronic gut disease * psychiatric disease * known sexual dysfunction

Keywords: sexual function pelvic floor disorders delivery mode
evaluate the efficacy and safety of acp-044 for the treatment of acute postoperative pain following bunionectomy

Conditions: Acute Postoperative Pain; Bunionectomy

Summary: to evaluate the efficacy of acp-044 compared with placebo in the treatment of acute postoperative pain


Eligibility criteria:
inclusion criteria: * male or female ≥18 and \<60 years of age at the time of screening * has a body mass index (bmi) \<40 kg/m2 * able to understand and provide signed informed consent * able to complete subject-reported outcome measures * is in need of a primary unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia and sedation * willing to remain inpatient at the study center for 4 days following surgery exclusion criteria: * has had a contralateral foot bunionectomy in the past 3 months * has a planned concurrent surgical procedure (e.g. bilateral bunionectomy or collateral procedures like hammertoe correction on the surgical foot) * any subacute or chronic pain condition or use of a medication that would impair/impact the ability to rate the pain associated with the bunionectomy, in the opinion of the investigator and medical monitor * has known or suspected regular use of opioids within the previous 6 months * has taken opioids within 24 hours prior to the scheduled surgery or within five half-lives of the drug, whichever is longer * has a known or suspected history of drug abuse, a positive drug screen at screening or day -1, or a recent (i.e., within the last 5 years) history of alcohol abuse. subjects using marijuana are not allowed to participate in the study. * has taken any aspirin (asa) or non-steroidal anti-inflammatory drugs (nsaids) within 2 days prior to the scheduled surgery or within five half-lives of the drug, whichever is longer * has initiated treatment with any medications within 1 month prior to study drug administration that could impact pain control or quantitation of their pain response * has been administered systemic steroids within five half-lives or 10 days prior to administration of study drug, whichever is longer * has current evidence, or medical history of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, endocrinologic, or other medical disorder, within the previous 12 weeks prior to screening and on day -1, that in the judgment of the investigator and/or medical monitor would jeopardize the safe participation of the subject in the study. also, subject must not have had a malignancy in the last year, with the exception of nonmetastatic basal cell of the skin or localized carcinoma in situ of the cervix. * is judged by the investigator or the medical monitor to be inappropriate for the study additional inclusion/exclusion criteria apply. patients will be evaluated at screening to ensure that all criteria for study participation are met. patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
heart safety study of ondansetron in children receiving chemotherapy

Conditions: Malignant Childhood Neoplasm

Summary: we will study the effects of ondansetron on measurements of electrical activity in the heart to make sure doses we are using to prevent nausea and vomiting in children receiving chemotherapy are safe.

children receiving chemotherapy for cancer at the jimmy everest center for cancer and blood disorders in children also often receive an iv dose of an antiemetic for prophylaxis. the most common antiemetics used are in the family of 5ht3 antagonists, specifically granisetron and ondansetron. prior to a recent recommendation by the fda, we have used ondansetron 0.45 mg/kg iv. based on adult ecg data, the recommended dose of ondansetron has been changed to no greater than 0.15 mg/kg. we have prior studies showing that the bigger dose is better at preventing nausea and vomiting. therefore we are studying ecg data in patients receiving ondansetron and chemotherapy. each subject will have two identical cycles of chemotherapy. prior to the first of the two cycles they will be randomized to receive one of two doses of ondansetron with the first cycle and the other dose with the second cycle. the two doses are the recommended dose of 0.15 mg/kg and a higher dose of 0.3 mg/kg. the dose level the patient receives each cycle will be blinded to the investigator and the subject. prior to the first dose of investigational ondansetron, the patient will have an ecg. this ecg will be repeated 30 minutes after the ondansetron is administered and just before chemotherapy administration, and repeated again 30 minutes later. the change in the qtc intervals will be calculated by two independent pediatric cardiologists who are also blinded to the ondansetron dose level received. this process will be repeated with the next course of chemotherapy, with the second dose of ondansetron. our goal is to see if there is an appreciable difference between the two doses in the qtc interval changes they induce.

Eligibility criteria:
inclusion criteria: * age 6 months to 18 years * diagnosis of cancer and receiving 2 identical cycles of chemotherapy within 2 months of each other exclusion criteria: * history of cardiac conduction anomalies, myocardial infarction, structural heart abnormalities (even if repaired) * pregnant or of child-bearing age and unwilling to take a pregnancy test * potassium or calcium outside of reference range at screening * liver enzymes (ast/alt) or bilirubin \>/= 2 x the upper limit of normal at screening

Keywords: pediatric ondansetron cardiac repolarization qtc interval
efficacy and safety for rituximab combined with telitacicept in the treatment of anca-associated vasculitis (ttcaavrem)

Conditions: ANCA Associated Vasculitis

Summary: this study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. the aim of this study is to investigate the remission rate of patients treated with telitacicept combined with rituximab in remission-induction and telitacicept alone in remission-maintain treatment.

background: the basic theme of aav is relapse and remission. the maintenance therapy of aav aimed to reduce or prevent relapse is very challenge. although many medications have been used for the maintenance of aav, telitacicept (a baff/april dual-target-inhibitor, which has been proved to be effect in treatment of sle) has not been studied yet. one study tested the efficacy of belimumab in the maintenance therapy for aav. when taken rituximab as remission-induction treatment, no relapse was observed. however, the sample size of this study is small, and the belimumab, as a baff inhibitor, was not been proved to have effect on april. many experiences have been accumulated about the efficacy and safety of telitacicept in chinese patients with rheumatic diseases. but there is no study to show its effectiveness in the reduction of the relapse of aav in china. in this study, we take telitacicept as maintain treatment in aav patients who receive rituximab as remission-induction treatment, to verify the effectiveness of telitacicept in maintenance therapy of aav. objectives: to investigate the effectiveness of telitacicept in reducing relapse rate by using from remission-induction treatment combined with rituximab to maintenance treatment of aav. study design: this is a prospective, randomized, open-label, control, pilot study.

Eligibility criteria:
inclusion criteria: 1. patients age 18 to 65 years, both genders can be included. 2. patients who are newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis must fulfill the 2022 acr/eular classification criteria of gpa or mpa. 3. patients have severe active aav according to the 2021 acr/vasculitis foundation definition. 4. patients have to be pr3-anca-positive at diagnosis or during the course of their disease. exclusion criteria: 1. patients who had been treated with rituximab but had to stop due to adverse events or intolerance. 2. patients who had other autoimmune diseases. 3. patients with severe liver dysfunction (defined as the 2-folds elevation of normal upper limit or child grade iii), heart failure or esrd (egfr\<30ml/min). 4. patients who are pregnant or have planned for pregnancy in next 2 years. 5. patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection. 6. patients with active hepatitis virus infection as well as patients who have active mycobacteria infection. 7. patients with malignancy. 8. patients who are not eligible according to the judge of the principal investigators.

Keywords: telitacicept relapse rate remission maintain treatment
relationship between acute phase markers and post-operative pain in open tension-free inguinal hernia repair: an observational study

Conditions: Post Operative Pain; Inguinal Hernia

Summary: many patients undergoing inguinal hernia repair are prone to developing acute and chronic post-operative pain. the aim of the study is to show a possible correlation between pain and acute phase proteins in order to: * predict the severity of pain; * select most suitable pain relief therapy for the patient.

the day after surgery, some serum markers are determined by a blood sample. the markers analyzed are: * leukocytes; * c-reactive protein (crp); * d-dimer; * fibrinogen; * neutrophil-to-lymphocyte ratio (nlr). pain level is assessed using the nrs scale at different times: * 1st post-operative day; * 7th post-operative day; * one month after surgery; * three months after surgery; * six months after surgery. other data collected for the study are: gender, age, bmi.

Eligibility criteria:
inclusion criteria: * patient undergoing open tension-free inguinal hernia repair exclusion criteria: * children
physical fitness and cardiovascular mortality in firefighters

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Hypertension; Obesity

Summary: to study prospectively the interrelationships among physical fitness, activity, other measured risk factors, coronary heart disease (chd) and all-cause mortality in a cohort of 3,403 firefighters.

background: from 1971-1991 the occupational health service of los angeles country measured physical fitness and other chd risk factors (including physical activity, anthropometric measures, blood pressure, smoking, family history of chd, and levels of total cholesterol, uric acid, and glucose) in los angeles county firefighters at application and routine intervals (approximately every three years). the entire cohort of 3403 firefighters is now followed for mortality up to 1996. design narrative: the entire cohort of 3,403 firefighers is followed up to 1996 in this longitudinal study. the investigators are using a variety of tracing sources, including the national death index, and obtaining death certificates to determine date and cause of death. cohort data will be analyzed to address the following aims: (1) to provide a longitudinal description of and determine the interrelationships among physical fitness, physical activity, and other measured risk factors; (2) to determine whether levels of physical fitness are related, independently of other known and measured risk factors, chd and all-cause mortality; (3) to determine whether there is a gradient of decreasing chd risk with increasing levels of physical fitness, or whether there appears to be some threshold of physical fitness, above which chd risk stabilizes; (4) to determine whether the relationship between physical fitness and chd and all-cause mortality varies by such cardiovascular risk factors as age, cholesterol levels, blood pressure, smoking, and obesity.

Eligibility criteria:
no eligibility criteria
detection of head pulse for ischemic stroke verification study

Conditions: Stroke, Acute

Summary: prehospital providers encounter patients with suspected stroke frequently. prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers. this device will identify large vessel stroke to ultimately improve triage decisions and optimize outcomes.

patients suspected of stroke by a prehospital provider will have a headset placed to record their headpulse during the encounter. these measurements will be used to assess the accuracy of the device at predicting the presence of large vessel occlusion (lvo) stroke. the mindrhythm, inc., harmony® 5000 device is intended to be used in the pre-hospital setting by medical professionals to diagnose large vessel occlusion stroke in adults suspected of having a stroke.

Eligibility criteria:
inclusion criteria: • suspected stroke in the prehospital setting exclusion criteria: * scalp laceration * patient refusal * prisoner, other vulnerable population * prehospital provider feels that the recording may interfere with care
bridging study for killed oral cholera vaccine in ethiopia

Conditions: Vibrio Cholerae; Cholera

Summary: this is a randomized, double blind, placebo controlled trial to confirm the safety and determine the immune response of the killed oral cholera vaccine in healthy adults and children in ethiopia.

this study serves as a bridging trial to evaluate the safety and immunogenicity of a two dose regimen of the wc-ocv (shanchol®) in ethiopian population. in order to assess whether the bivalent killed oral cholera vaccine may be used safely among those who are most at risk for cholera, we need to determine the safety and immunogenicity of the killed oral cholera vaccine. the vaccine was evaluated in a large number of human subjects in india vietnam, and bangladesh, in which it has demonstrated safety, immunogenicity, and clinical protective efficacy. though we do not expect the vaccine to act differently in the ethiopian population, we aim to confirm our presumptive understanding that two doses of wc-ocv is safe and immunogenic in healthy volunteers at one year and above (exclusive of pregnant women). findings from this study can pave the way for the possible use of the killed whole cell oral cholera vaccine in both endemic and outbreak settings at a larger scale.

Eligibility criteria:
inclusion criteria: 1. male or female adults aged 18 years and above; and children aged 1 -17 years who is available for follow-up visits and specimen collection. * the subject should be able to continue in the study for the next 4 weeks * the subject (or parent/guardian) should be willing to provide 3 blood samples 2. for females of reproductive age, non-pregnant (as determined by urine pregnancy test). 3. written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 - 17 years. 4. healthy subjects as determined by: * medical history * physical examination * clinical judgment of the investigator exclusion criteria: 1. ongoing chronic recurring illness which may cause systemic symptoms as judged by the investigating physician. 2. ongoing acute illness. 3. for females of reproductive age: pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening) 4. immunocompromising condition or on chronic systemic steroid therapy 5. diarrhea (3 or more loose/more watery stools within a 24-hour period) within 6 weeks prior to enrollment 6. intake of any anti-diarrhea medicine in the past week 7. abdominal pain or cramps, loss of appetite, nausea, or vomiting in the past 24 hours 8. temperature ≥38ºc (oral or axillary) warrants deferral of the vaccination pending recovery of the subject 9. previous hypersensitivity to formaldehyde. 10. receipt of immunoglobulin or any blood product during the past 3 months 11. receipt of oral cholera vaccine in the past three years 12. any potential subject currently participating or who will participate within the next six months in another clinical trial 13. positive screening urine pregnancy test for females greater than 12 years of age

Keywords: oral cholera vaccine safety and immunogenicity bridging study ethiopia
sublingual versus vaginal misoprostol in medical treatment of first trimestric missed miscarriage

Conditions: Missed Abortion

Summary: the aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.

in women with first trimetric-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.

Eligibility criteria:
inclusion criteria: * all women above 18 years of age * less than 12 weeks of gestation. * pregnancy is confirmed by pregnancy test or ultrasound scan. * missed abortion * normal general and gynecological examination. * the size of the uterus on pelvic examination was compatible with the estimated duration of pregnancy exclusion criteria: * hemodynamically unstable. * suspected sepsis with temperature 38 °c. * concurrent medical illness e.g. hematological, cardiovascular, thromboembolism, respiratory illnesses, recent liver disease or pruritus of pregnancy. * presence of intrauterine contraceptive device (iucd). * suspect or proven ectopic pregnancy. * failed medical or surgical evacuation before presentation. * known allergy to misoprostol.