Kornimate/medical-research-clean huggingface dataset:
a long-term treatment extension study of niraparib in participants who completed a prior glaxosmithkline/tesaro-sponsored niraparib study

Conditions: Ovarian Neoplasms; Breast Neoplasms

Summary: this is a global extension study to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment in participants who are currently receiving treatment with niraparib within glaxosmithkline/tesaro-sponsored studies (nct01847274, nct02354586, nct01905592, nct03308942, nct02657889) that has fulfilled the requirements for the primary objective.


Eligibility criteria:
inclusion criteria: * participant is able to understand the study procedures and agrees to participate in the study by providing written informed consent. * participant is willing and able to comply with scheduled visits, treatment plans, and any other study procedures. * participant is currently receiving treatment with niraparib (as monotherapy or in combination) in a glaxosmithkline/tesaro-sponsored study that has fulfilled the requirements for the primary objective. * participant is currently benefiting from treatment with niraparib as assessed by the investigator according to the parent study protocol requirements. * participants of childbearing potential who are sexually active and their partners must agree to the use of an effective form of contraception throughout their participation during study treatment through 180 days after last dose of study drug. exclusion criteria: * participant has been permanently discontinued from niraparib treatment in the parent study for any reason. * participant currently has unresolved toxicities for which niraparib dosing has been interrupted in the parent study. participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow niraparib treatment to resume. * participant is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. participant is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use during niraparib treatment and for 30 days after receiving the final dose of study treatment).

Keywords: adverse events open-label extension parent study niraparib safety
low energy availability and pituitary function (leap study)

Conditions: Hypogonadotropic Hypogonadism

Summary: the purpose of this study is to learn more about reproductive hormones and if they change in response to 5-days eating an individualized, standardized diet at two levels: energy balance and low energy intake.


Eligibility criteria:
inclusion criteria: * female * age 18-30 * body mass index between 18.5-24.9 or 30-45 * have regular menstrual cycles between 18-40 days over the past 6 months * weight stable (not gained or lost 5kg) in the past 3 months exclusion criteria: * using hormonal birth control currently or within the past three months * polycystic ovary syndrome (current or past diagnosis) * pregnant, lactating, planning to become pregnant in next 6 months * engaging in regular intentional aerobic exercise * significant medical issues (e.g.,cardiovascular disease or diabetes)
effects of red blood cells transfusion on renal blood flow

Conditions: Acute Kidney Injury; Transfusion-Associated Circulatory Overload; Anemia; Fluid Overload

Summary: the renal doppler resistive index (rri) is a noninvasive tool that has been used to assess renal perfusion in the intensive care unit (icu) setting. it is associated with the occurrence of acute kidney injury (aki). many parameters have been described as influential on the values of renal ri. red blood cell (rbc) transfusion were shown to be able to increase renal oxygenation in animal model, whereas crystalloid resuscitation did not. we sought to describe the different effect of crystalloids infusion and rbc transfusion on renal blood flow, as evaluated with doppler ultrasound


Eligibility criteria:
inclusion criteria: * age \> 18 and \< 90 * hemoglobin ≥7 and ≤ 10 g/dl exclusion criteria: * ultrasound rri evaluation non available * patients with arrhythmia * pregnancy * refusal to give consent * history of renal transplantation * central venous access in superior vena cava not available critical active bleeding
autism intervention research network for behavioral health (air-b ii): deployment into elementary schools

Conditions: Autism

Summary: the primary goal of this study is to identify efficacious and cost effective intervention strategies that can improve academic and psychological outcomes for children with asd, and can be feasibly be implemented at fidelity by school personnel in under served elementary schools. two simultaneous interventions will occur. in intervention 1, students with asd in inclusion classrooms will be randomized to the playground intervention or a waitlist control group. in the playground intervention, ucla/roc/upenn staff will work with school personals (teachers, paraprofessionals) to increase peer engagement on the yard. in intervention 2, students in special day classes will be randomized to the 'schedule tools activities transitions' intervention (stat) or wait-list control. in the stat intervention, ucla/roc/upenn staff will work with teachers to implement behavioral strategies in the classrooms. in both interventions, the conditions are: 1) immediate treatment, where the training will begin immediately after baseline measures are completed. 2) wait-list treatment, where the training will begin the follow school year.


Eligibility criteria:
inclusion criteria: 1. child: child has to meet the following criteria: 1) child's primary classroom teacher has consented to participate, 2) child meets ados research criteria for autism spectrum disorder, 3) child is between 5-11 years old, 4) child's parents consented to have child participate, and 5) child is placed in inclusion classroom or self-contained special education classroom for a minimum of 50% of the school day. 2. adult: school teachers and paraprofessionals working with children with asd. exclusion criteria: 1. child: participants will be excluded from the study if child has co-morbid disorders such as cerebral palsy, fragile x, down syndrome. child has profound vision or hearing lose. 2. adult: participants will be excluded from the study if the adult is not a teacher, administrator, teaching assistant, yard attendant, related services provider, or a paraprofessional.

Keywords: autism school based intervention
metabolic syndrome and male infertility

Conditions: Male Infertility

Summary: multidisciplinary, multicentric, cross-sectional study on men in infertile couples who conduct their sperm test through their diagnosis of infertility

assessment of sperm parameters and metabolic syndrome relations in men attending a reproductive biomedicine centre for an infertility of their couple. secondary objectives are to study relationship between sperm parameters and: * adiposity and insulin resistance * inflammation * oxydative stress in blood and semen * hormonal status innovative parameters will also be assessed to determine the quality of semen (length of fingers, wrist circumference and epigenetics studies)

Eligibility criteria:
inclusion criteria: * 18 to 45 years-old man * man consulting for primary or secondary infertility, with or without earlier notion of paternity * patient insured with a social security scheme * patient who have had a prior medical consultation * patient who have done informed and written consent to participate in the research study exclusion criteria: * patient with problems understanding french * patient smoking more than two-pack-a-day * patient monitoring for viral risk. * man with an unidiopathic infertility which may be explained by: 1) identifiable factors in direct questioning at the sperm analysis: * exposure to toxic products * infectious disease history * pathological anatomical background 2) factors identified at the etiologic investigation: cytogenetic and genetic

Keywords: metabolic syndrome epigenetic male infertility sperm parameters biomarkers
comparison of the clinical success of pediatric zirconia crowns applied with different luting cements

Conditions: Dental Caries; Dental Plaque; Dental Caries in Children

Summary: this randomized controlled trial aims to evaluate and compare the clinical outcomes of prefabricated zirconia crowns (pzcs) for primary molars cemented with different luting cements. the main questions to answer are: will there be any difference in the clinical success regarding retention among the pzcs cemented with different luting cements? will there be any difference in the clinical success regarding periodontal health among the pzcs cemented with different luting cements? will there be any difference in the clinical success regarding pulpal survival among the pzcs cemented with different luting cements? fifty-three children (60 teeth), between 5 and 11 years old enrolled for the study. researchers will compare the retention status, plaque index (pi), gingival index (gi), and probing depth (pd) scores, and endodontic/periodontal pathology of pzcs. participants will: - visit the clinic 1st,3rd,6th,12th months after the restoration.


Eligibility criteria:
inclusion criteria: patients: * no history of allergies * a frankl scale score of 3 or 4 * has at least one carious primary molar teeth: * no percussion or palpation sensitivity * no pathological root resorption * no abscess and/or fistula * no radiolucency at the furcation area * no prior pulpal treatment * presence of permanent successor * no mobility or periodontal disease * normal position of permanent successor * an interproximal decay and/or extensive decay with at least 2 surfaces * if present, physiological root resorption no more than one-third of the root * opposing teeth in occlusal contact * normal lamina dura and periodontal space exclusion criteria: * congenital and/or developmental defects * history of bruxism * skeletal and/or dental malocclusion * history of trauma * infraocclusion
intravenous metoprolol in septic shock

Conditions: Septic Shock; Ventilator Acquired Pneumonia

Summary: a rct designed to assess the effect of giving intravenous beta-blockers in patients with septic shock after achieving hemodynamic stability. the principle of this study is to control heart rate allowing for better diastolic filling and thus better perfusion.

a rct, conducted at alexandria main university hospital, patients were divided into 2 groups, control group which received the standard care for septic shock and metoprolol group which recieved intravenous metoprolol then patients were assessed for blood pressure, heart rate, iv fluids needed, vasopressor doses and 28 days mortality

Eligibility criteria:
inclusion criteria: * the study population included adult patients (≥ 18 years) diagnosed with septic shock secondary to vap with sinus tachycardia, from april 1, 2022, to april 31, 2023. septic shock was defined according to the third international consensus definitions for sepsis and septic shock (sepsis-3). vap was identified as per the guidelines provided by the american thoracic society and infectious diseases society of america. exclusion criteria: * patients were excluded if they had contraindications to beta-blockers, had a history of heart failure, or had been receiving beta-blockers prior to the septic shock. patients were also excluded if they developed complications from beta- blockers administration.

Keywords: beta blockers septic shock rate control mortality
effect of high-dose b-complex vitamins on the symptoms of schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the purpose of this study is to determine whether individuals with schizophrenia who will take a high dose of the b-vitamins folate, b12 and pyridoxine, may experience improvement in their symptoms.

individuals with schizophrenia often experience disturbing residual symptoms, even with the best available current treatments. homocysteine, normally found in the body, can interfere with nmda-glutamate receptor function, and this might be responsible for some of the symptoms of schizophrenia. this double-blind protocol will have study participants who suffer from schizophrenia take either a high-dose combination of folate, b12 and pyridoxine (a combination that can lower homocysteine in the body) or placebo for three months. clinical measures (e.g., panss, cgi) will be taken to determine whether those taking the vitamin combination experience clinical benefit.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia or schizoaffective disorder * ages 18-65, male or female * treatment regimen includes a new-generation antipsychotic (clozapine, olanzapine,risperidone, quetiapine, ziprasidone or aripiprazole) * stable medication for 4 weeks prior to screening visit exclusion criteria: * diagnosis of active substance use disorder within the last month * already taking vitamin supplements totaling \> 400 mcg folic acid per day, or regular b12 injections * pregnant or breastfeeding * seizure disorder * non-english speaking * without capacity to give informed consent

Keywords: schizophrenia schizoaffective disorder homocysteine vitamins
phase iv:safety and efficacy of emsam in adolescents with major depression

Conditions: Major Depressive Disorder

Summary: the primary purpose of your participation in this study is to help answer the following research question: whether 12-week administration of emsam (selegiline transdermal system) is safe and effective for the treatment of adolescents (aged 12 through 17 years) with major depressive disorder (mdd).

• assess the safety and efficacy of emsam (selegiline transdermal system) versus placebo in adolescents (aged 12 through 17 years) who meet criteria for major depressive disorder (mdd) without psychotic features, single or recurrent

Eligibility criteria:
inclusion criteria: * male / female outpatients 12 to 17 years of age diagnosed with major depressive disorder (mdd). (must have a children's depression rating scale-revised \[cdrs-r\] with a total score of at least 45 at screening.) * female patients must test negative on a pregnancy at visit 1. * weight and height must be greater than the 10th percentile according to age and height, * assent and consent must be given. exclusion criteria: * have a serious or unstable medical illness, psychological condition, clinically significant laboratory or ecg result, hypersensitivity to selegiline, or any other condition that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study. * have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, pervasive development disorder or borderline personality disorder, as determined by the investigator. * have a risk of suicide * female patients who are either pregnant, nursing or have recently given birth. * use of any protocol prohibited medications or substances.

Keywords: mental health adolescents major depressive disorder depression adolescent depression pediatric depression
safety study of vasopressin v2 receptor antagonist on patients with severe chronic heart failure (aquavit).

Conditions: Chronic Heart Failure

Summary: this is a randomized, double-blind, placebo-controlled, parallel-group forced up-titration study. randomization will be stratified according to the patient's baseline serum sodium concentration (137-144 and \<137 mmol/l). the dose of study drug will be increased to the next level on day 15, and the total duration of the double-blind treatment period is 120 days.


Eligibility criteria:
* men or women with chronic heart failure (nyha class iiib and iv). * women must be post-menopausal or surgically sterilized; they cannot be pregnant or nursing. * age 21 to 80 years. * chronic heart failure of at least 3 months duration. for 2 months prior to screening, patients must have had symptoms at rest or on minimal exertion for more than 50% of the time. for 2 weeks prior to screening, patients must have had symptoms at rest or on minimal exertion for more than 90% of the time. * patients must be receiving a diuretic and an ace inhibitor (or an angiotensin ii receptor antagonist) for the treatment of heart failure. * patients may be receiving digoxin, a beta-blocker or spironolactone

Keywords: chronic heart failure heart disease
safety and efficacy of deferasirox in patients with transfusion dependent iron overload - a non-comparative extension study

Conditions: Liver Iron Overload

Summary: the purpose of this study is to assess the safety and the effects on liver iron of deferasirox when given for a long treatment period in patients with transfusion dependent iron overload.


Eligibility criteria:
inclusion criteria: * patients currently participating in the 9-month comparative prolongation of extension phase of the original study. * patients currently participating in the food-effect sub-study, according to amendment 3. * ability to provide written informed consent prior to participation in this non-comparative extension study. * female patients sexually active must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation. * body weight of at least 35 kg. exclusion criteria: * pregnant or breastfeeding patients. * history of non-compliance to medical regimens and patients who are considered potentially unreliable. * proteinuria \> 300 mg/l second void morning urine. * patients with serum creatinine above the upper limit normal. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: iron overload iron chelation therapy b-thalassemia
(s5-samu) randomized study comparing the asv (adaptative support ventilation) to conventional ventilation

Conditions: Respiratory Distress Syndrome

Summary: compare ventilation parameters in adaptative support ventilation mode to conventional mode, on intubated, ventilated and sedated patients, during their secondary transfer from an hospital to another, by a smur team.


Eligibility criteria:
inclusion criteria: * intubation * secondary transfer (interhospital) * informed patients / close relations, signed consent exclusion criteria: * primary transport of a ventilated, intubated, sedated patient * patient in limitation and stop of active therapeutics, dying person * broncho pleural fistula * patient under ecmo * patient included in another research submitted to consent * supervision, loss of liberty * pregnant woman
effects of nordic walking on prenatal health

Conditions: Prenatal Care; Walking

Summary: this randomized controlled trial (rct) aimed to evaluate the effects of nordic walking (nw) on gait kinematics, musculoskeletal pain, and quality of life in pregnant women.

healthy pregnant women (n=50), aged 20-40 years and between 13 and 28 weeks of gestation, experiencing mild to moderate musculoskeletal pain, will be recruited. participants will be randomized into either an intervention group (nw training) or a control group receiving standard prenatal care. the intervention group will undergo a 4-week learning phase followed by an 8-week nw program (3 sessions per week, 45 minutes per session), led by a certified instructor. outcome measures will be assessed at baseline, after 4 weeks, and post-intervention (8 weeks), including spatiotemporal gait parameters (will be assessed using the gaitrite system), musculoskeletal pain (will be measured via visual analog scale, vas), and quality of life (will be measured using the sf-36 health survey).

Eligibility criteria:
inclusion criteria: * healthy women aged 20 to 40 between 13 and 28 weeks into singleton pregnancy. * participants must be experiencing mild to moderate musculoskeletal discomfort, such as lower back or pelvic pain, * participants have no prior musculoskeletal or neurological diseases. * they must have no contraindications to exercising throughout pregnancy, as established by obstetrician clearance, and be able to engage in moderate physical activity under medical recommendations exclusion criteria: * history of diseases affecting bony structures or lumbar intervertebral discs. * pain caused by non-musculoskeletal factors (such as urinary tract infections or obstetric complications). * multiple pregnancies, pre-existing mobility conditions, and high-risk pregnancies or complications that restrict physical activity.

Keywords: prenatal health nordic walking pregnancy musculoskeletal pain gait parameters quality of life
progesterone for the management of preterm, premature rupture of the membranes: a randomized controlled trial.

Conditions: Pregnancy Complications

Summary: preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. it has been shown that the drug 17-hydroxyprogesterone caproate can help reduce the risk of preterm delivery in women with certain risk factors for preterm birth. we hope to learn whether this same medication can be used to prolong pregnancy in a group of patients in whom this medication has not been previously studied. specifically, we hope to learn whether progesterone supplementation will delay delivery in women with pre-term, premature rupture of membranes (pprom).

when women present to either the obstetrical clinic or labor and delivery with a complaint of possible preterm, premature rupture of membranes (pprom), they will be examined by an obstetrician to either confirm or rule out this diagnosis. if they are diagnosed with pprom, they will then be admitted to lucile packard children's hospital and treated with the normal protocol which includes receiving antibiotics, receiving steroids, being hospitalized until delivery, and having ongoing maternal and fetal monitoring for possible complications. the patients will be identified by their treating obstetricians as possible study candidates and asked by a member of the treatment team if they are potentially interested in participating in a research study. subsequently, a member of the study team or the treating physician will approach the patient about participating in the trial. those who choose to participate will receive the standard care protocol in addition to receiving the study medication. the study medication will be a weekly injection of either placebo or 17-hydroxyprogesterone caproate or placebo. the placebo medication (castor oil) was chosen as it has been used in previous studies as a placebo for 17-hydroxyprogesterone caproate. the choice of which medication the patient receives will be determined by a randomization table. only the pharmacist will be aware of the medication that has been administered. the patient, members of the treatment team, and members of the study team will be blinded to the medication that is being administered. the timing of their delivery will be managed by the treating obstetrician according to standard medical practice. after delivery, the patient's and her infant's medical outcomes will be recorded for analysis.

Eligibility criteria:
inclusion criteria: 1. 18yr of age 2. singleton pregnancy 3. pprom confirmed on clinical exam 4. ga between 24+0 and 33+5 wk 5. ability to understand consent in either english or spanish exclusion criteria: 1. contraindication to ongoing pregnancy including: 1. evidence of active infection 2. evidence of significant placental abruption 3. iufd diagnosed at the time of p-prom diagnosis 2. major fetal malformation 3. maternal allergy to progesterone or placebo drug components 4. current use of progesterone at the time of p-prom 5. multiple gestations 6. inability to understand consent in either english or spanish