Kornimate/medical-research-clean huggingface dataset:
brain-imaging and adolescent neuroscience consortium

Conditions: Alcohol Abuse

Summary: this is a multi-site study of adolescents 12-21 years-of-age to evaluate the long and shorter-term effect of adolescent alcohol use on the developing brain.

the overall specific aims of this study are to: 1) assess the short and long-term consequences of alcohol exposure on brain, cognitive, and emotional/regulatory development during preadolescence and adolescence; 2) determine the effects of timing, dose, and duration of alcohol on brain and cognitive development; 3) assess recovery of neural and behavioral function to determine if the plasticity of the adolescent brain makes it more or less vulnerable to alcohol's acute and chronic effects; 4) understand how other key covariates (e.g., existing or emerging psychopathology, family history of alcoholism, demographics, pubertal development) factor into alcohol's effects on the brain; and 5) identify early neural, cognitive, and affective markers that may predict alcohol abuse and dependence during adolescence and/or adulthood.

Eligibility criteria:
inclusion criteria: * able to read and understand english * available for follow-up * parental consent/adolescent assent for those 12-17 years * consent for those 18-21 years exclusion criteria: * weight \> 300 lbs * braces or unremovable embedded metal * claustrophobia or inability to lie still in mri machine * current or past 12-mos pregnancy (females) * requires urgent medical/mental health care

Keywords: alcohol abuse
addition of herceptin to a carboplatin-paclitaxel regimen in patients with ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to evaluate whether or not the addition of herceptin may be of benefit to a standard regimen of carboplatin-paclitaxel.


Eligibility criteria:
inclusion criteria: * 18 years or older; patients with histologically proven diagnosis of ovarian cancer. * patients with metastatic disease and an overexpression of her2 (as determined by immunochemistry) * patients who have progressed while receiving treatment, or within 6 months after completion of treatment. patients must have received carboplatin and paclitaxel. * patients who have received at minimum one line of chemotherapy * 3 weeks minimum since last treatment with chemotherapy must have elapsed * patients must have at least 1 measurable lesion per response evaluation criteria in solid tumors (recist) or an assessable cancer antigen (ca) 125 \> 1.25 x upper limit of normal (uln) * patients must have ecog of 2 or less * left ventricular ejection fraction (lvef) of 50% or better * patients have given their signed and verbal consent exclusion criteria: * previous treatment with herceptin or similar products affected growth factors (eg: iressa) * another experimental treatment in the previous 30 days * no overexpression of her2 receptors * patients having received high-dose chemotherapy or stem-cell interventions * other cancers within the last 5 years * patients with dyspnea at rest or requiring oxygen therapy

Keywords: herceptin carboplatin paclitaxel relapse
a study evaluating sleep, stress and infant nutrition using a chatbot

Conditions: Preterm Birth; Healthy

Summary: 20 parents with healthy preterm infants (born at \<37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment will be enrolled to obtain records of sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot.

20 parents with healthy preterm infants (born at \<37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment will be enrolled to obtain records of sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot. data obtained from parents of preterm infants and parents of full-term infants on sleep, stress, and infant nutrition will be compared. an evaluation of the usability of the mobile app hosting the chatbot, the study chatbot and its functionality in general among this population will also be conducted

Eligibility criteria:
inclusion criteria: subjects (parent and infant) must meet the following criteria: * healthy infants (preterm and full-term) must be 0-6 months of age at time of enrollment * infants must be at home (discharged from the hospital) at time of enrollment * informed consent from parent whose age is ≥21 years * parent must be proficient in the english language * parent must be able to comply with the required study tasks, as per pi's judgment * in-home access to reliable internet connections; a mobile device suitable for electronic communication exclusion criteria: infant must not meet any of the following criteria: * known to have current or previous illnesses/conditions which could interfere with the study outcome (per pi's clinical judgment) * must not be currently participating in any other clinical study parent must not meet any of the following criteria: * must not be known to have a significant medical condition that might interfere with the study (per pi's clinical judgment) that meets one of the following criteria: * presence of current mental illness or history of mental illness * any acute or chronic illness that makes the parent unsuitable for the study based on the pi's judgment * must not be a single parent * inability of the parent to comply with the study protocol or pi's uncertainty about the willingness or ability of the parent to comply with the protocol requirements
prevalence of thyroid dysfunction and anti-thyroid antibodies in infertile women

Conditions: Infertility, Female

Summary: the study population will be divided into three groups: * group (a) consisting of 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility, * group (b) consisting of 40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility, and * group (c) consisting of 40 women with exclusive male factor of infertility and will be used as a control group. . all women will be subjected to: * informed consent * full history taking, including age, duration of infertility and whether primary or secondary * general and pelvix examination * trans-vaginal ultrasonography * determination of hormonal profile (fsh, lh, estradiol, prolactin) * determination of ovulatory status * determination of of tubal patency * determination of presence of male factor * determination of tsh and antithyroid antibodies (antithyroglobulin and antithyroid peroxidase) blood levels

the study population will be divided into three groups: * group (a) consisting of 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility, * group (b) consisting of 40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility, and * group (c) consisting of 40 women with exclusive male factor of infertility and will be used as a control group. . all women will be subjected to: * informed consent * full history taking, including age, duration of infertility and whether primary or secondary * general and pelvix examination * trans-vaginal ultrasonography * determination of hormonal profile (fsh, lh, estradiol, prolactin) * determination of ovulatory status (by previous documented history of induction of ovulation or previous ultrasonography or previous estimation midluteal serum progesterone, etc ...) * determination of of tubal patency (by previous hysterosalpingiography or laparoscopy) * determination of presence of male factor (by seminal fluid analysis) * determination of tsh and antithyroid antibodies (antithyroglobulin and antithyroid peroxidase) blood levels

Eligibility criteria:
inclusion criteria: * - age: 18 - 38 years * infertile women whether due to functional, anatomical, male factors or unexplained or combined factors exclusion criteria: * - age: below 18 and above 38 years * patients with autoimmune diseases (such as lupus and rheumatoid arthritis) * acute illness that require hospitalization * patients on the following medications: steroids, dopamine, iodine, amiodarone, lithium, donperidone, thyroid hormone, and phenytoin. * patients who work at night.
hormone replacement therapy for use in postmenopausal women for relief of hot flushes and urogenital symptoms.

Conditions: Hormone Replacement Therapy

Summary: multicenter, double-blind, controlled, parallel group, randomized study to compare the clinical benefit of estradiol acetate tablets, estradiol tablets and conjugated equine estrogen tablets, each administered orally, once daily, to postmenopausal women.


Eligibility criteria:
inclusion criteria: 1. age ≥ 40 years of age; bilateral oophorectomy ≥ 35 years of age. 2. non-hysterectomized women: * amenorrhea for ≥ 12 months or * amenorrhea for ≤ 12 months, but longer than 6 months, and serum fsh (follicle stimulating hormone) levels \> 40 units/l and serum estradiol levels \< 20 pg /ml, hysterectomized women: * bilateral oophorectomy - subjects may enter the study 6 weeks after surgery or * history of removal of ovaries may be confirmed by - serum fsh levels \> 40 units/l and serum estradiol levels \< 20 pg/ml or via surgical report / ultrasound. 3. seven or more moderate or severe hot flushes daily for 1 week or 60 or more moderate or severe flushes in 1 week during the 2 week screening period prior to study entry. exclusion criteria: 1. hormone therapy administered via the following routes and during the specified timeframes: oral within 8 weeks, vaginal (rings, creams, gels) within 1 week, transdermal within 4 weeks, intramuscular within 6 weeks, progestational implants, estrogen or estrogen/progestational injectable drug therapy within 3 months, estrogen pellet or progestational injectable within 6 months. 2. abnormal pap smear suggestive of low grade squamous intraepithelial lesion (lgsil) or worse. enrollment of subjects with an ascus (atypical squamous cells of undetermined significance) interpretation must be discussed with the sponsor prior to randomization. 3. urinary tract infection 4. congestive heart failure 5. uncontrolled hypertension; sitting systolic bp ≥ 160 mmhg or diastolic ≥ 95 mmhg 6. history of stroke or transient ischemic attacks 7. treatment with anticoagulants (heparin or warfarin). 8. uncontrolled thyroid disorders. 9. insulin-dependent diabetes mellitus. 10. increase frequency or severity of headaches including migraines during previous estrogen therapy.
bandage contact lens in post operative ptosis patients

Conditions: Ptosis; Blepharoptosis

Summary: this study is being conducted to determine whether the use of bandage contact lens after ptosis surgery provides any benefits for the patient or is unnecessary.

this study is being conducted to determine whether the use of bandage contact lens after ptosis surgery provides any benefits for the patient or is unnecessary. the investigators hope to show through questionnaires based on the patient's experience after their surgery to see if the bandage contact lens has provided any benefit for the patient. this is a randomized control trial in which patients undergoing bilateral ptosis surgery (fasanella servat procedure) will have one of their eyes randomized to receive a bandage contact lens after surgery while the other eye will not receive anything.in this randomized control trial, patients requiring surgery with bilateral ptosis will have one eye randomized to receive a bandage contact lens whereas the other eye will not after their surgery. follow up will occur in one week where the outcomes will be obtained through questionnaires.

Eligibility criteria:
inclusion criteria: * patients who have bilateral ptosis (drooping eyelids) and will require surgery to correct this exclusion criteria: * patient having any other eye related pathologies

Keywords: ptosis blepharoptosis bandage contact lens fasanella servat procedure
effect of zoledronic acid on femoral bone loss following total hip arthroplasty

Conditions: Osteoporosis

Summary: in a randomized, double-blind trial, bmd of the operated proximal femur after total hip replacement measured by dual-energy x-ray absorptiometry (dxa) were compared for up to two years in patients receiving iv zol 5 mg infusion (n = 27) or placebo (iv saline infusion; n = 24) at two weeks and one year after surgery.


Eligibility criteria:
inclusion criteria: * patients undergoing primary elective total hip replacement exclusion criteria: * osteoporosis (bmd ≤-2.5) * trauma to the operated femur, hip revisions, femoral dysplasia, trochanteric osteotomy, inflammatory arthritis * severe renal impairment * use of any medications affecting bmd * known sensitivity to bisphosphonates * severe dental problems, and pregnancy or being able to conceive and not using reliable birth control methods
molecular genetics of heterotaxy and related congenital heart defects

Conditions: Heterotaxy Syndrome; Congenital Heart Defects

Summary: the goal of this study is to obtain specimens and data from individuals and their families with heterotaxy and related congenital heart defects in order to clarify the molecular genetics of this disorder. the knowledge gained from the analysis of this information will provide the basis for future genetic counseling as well as contribute to knowledge about the biology of normal and abnormal development of left-right anatomic asymmetry.

heterotaxy syndrome is a rare birth defect that involves the heart and other organs. many cases are genetic. fundamental lack of information about the genetic basis of heterotaxy and related congenital heart defects in the vast majority of children has hindered management and therapy. the study outlined in this protocol is designed to obtain information about the causes of heterotaxy and related congenital heart defects. in this study, investigators will perform genetic analyses on patients with heterotaxy and related congenital heart defects, or individuals at risk for these abnormalities. the investigators will collect medical information related to symptoms and disease course. these results will provide important information on the causes, management, and prognosis of heterotaxy and related congenital heart defects.

Eligibility criteria:
inclusion criteria: * subjects with heterotaxy and related congenital heart defects * family members of subjects with heterotaxy and related congenital heart defects exclusion criteria: * subjects without heterotaxy and related congenital heart defects * family members of subjects without heterotaxy and related congenital heart defects

Keywords: abnormalities, multiple asplenia bilary atresia birth defect cardiovascular abnormalities cardiovascular diseases congenital abnormalities congenital heart disease dextrocardia syndrome disturbed internal organ positioning genetics genetic testing heart defects, congenital heart diseases heterotaxy syndrome intestinal malrotation laterality left atrial isomerism pediatrics polysplenia right atrial isomerism splenic diseases cilia situs inversus dextrocardia
a study of cc-99677 in participants with active ankylosing spondylitis

Conditions: Spondylitis, Ankylosing

Summary: this study is designed to learn about response to cc-99677 treatment by measuring signs and symptoms of ankylosing spondylitis (as), objective measures of disease activity, quality of life assessments, pharmacokinetics, safety, and tolerability over a 12-week double-blind period.


Eligibility criteria:
inclusion criteria: * diagnosis of ankylosing spondylitis (as) fulfilling the modified new york criteria * active axial disease at screening and baseline defined by a bath ankylosing * spondylitis disease activity index (basdai) score ≥ 4 and total back pain ≥ 4 * failed prior treatment with at least 2 nsaids for at least 4 weeks each * participant has never received a biologic therapy eg, tumor necrosis factor (tnf) antagonist or monoclonal antibody \[mab\] against il-17a (biologic naive main study), or have taken more than one biologic therapy (biologic-failure substudy) for the treatment of as exclusion criteria: * radiographic evidence of total ankylosis of the spine * clinically significant back pain caused by diseases other than as * concurrent treatment or treatment within the 6 months prior to baseline with cell depleting biologic agents * participation in any study of an investigational drug, including those for covid-19 * history of malignancy * oral corticosteroids (prednisone or equivalent) \> 10 mg/day systemically for ≥ 2 weeks prior to baseline visit

Keywords: ankylosing spondylitis cc-99677 mk2inhibitor spinal diseases bone diseases musculoskeletal diseases arthritis joint diseases
assessment of liver fibrosis by real-time tissue elastography in chronic liver disease

Conditions: Chronic Hepatitis B; Chronic Hepatitis C

Summary: this is a multi-center cross-sectional study in which the real-time tissue elastography® measurements will be collected prospectively from patients with chronic hepatitis b or c virus presenting for liver biopsy.

the aim of this study is to validate the diagnostic value of real-time tissue elastography® by comparison with liver histology, serum marker or fibroscan® in chronic hepatitis b or c patients.real-time tissue elastography®, biopsy and serum maker are performed. if in the hospital they can perform fibroscan®, fobroscan® also be performed. the subjects must be scheduled for liver biopsy either prior to treatment (treatment naïve) or, if previously treated, they must have been off treatment for at least six months. the time between the real-time tissue elastography® , biopsy, blood sampling and firoscan® must not exceed four weeks.

Eligibility criteria:
inclusion criteria: * male or female and at least 20 years of age * chronic hepatitis b or chronic hepatitis c * subject is willing to fast for 8 hours prior to each study visit exclusion criteria: * history of alcohol abuse (alcohol intake \> 20g/day) * evidence or history of chronic hepatitis not caused by hbv or hcv * during 6 months before registration to this trial has completed, nucleic acid analogue preparations or interferon therapy was performed. * pregnant or lactating patients * contraindications of liver biopsy or liver resection

Keywords: hepatitis b virus hepatitis c virus chronic hepatitis liver cirrhosis liver stiffness liver fibrosis
pharmacokinetic assessment of the absorption of estradiol in postmenopausal women with atrophic vaginitis

Conditions: Menopause; Postmenopausal Vaginal Atrophy

Summary: this trial is conducted in europe. the aim of this trial is to to evaluate the extent of systemic absorption of estradiol during treatment with two different doses of estradiol in postmenopausal women with atrophic vaginitis.


Eligibility criteria:
inclusion criteria: * subjects who are able to use german language in speaking and writing * postmenopausal women with at least 5 years after last menstruation, or bilateral oophorectomy performed two years or more prior to the time of screening * serum fsh (follicle stimulating hormone) levels above 40 miu/ml and estradiol below 20 pg/ml * maximum 5% superficial cells as assessed by evaluation of vaginal cytology * endometrial thickness below 4.0 mm (double layer), as measured by transvaginal ultrasound (if applicable) * availability of a normal mammogram within one year prior to trial start * good general health as assessed by the investigator and based on medical history, and physical and laboratory examinations exclusion criteria: * known or suspected allergy to trial product or related products * known, suspected or past history of breast cancer * known, suspected or past estrogen dependent neoplasia e.g. endometrial cancer * endometrial hyperplasia or endometrial polyps diagnosed during the screening period * abnormal genital bleeding of unknown etiology * previous estrogen and/ or progestin hormone replacement therapy
protective effect of propofol against hemolysis in patients submitted to gastroplasty

Conditions: Hemolysis

Summary: the purpose of this study is to determine if propofol could protect erythrocytes by directly scavenging free radicals from the blood current and increasing resistance of their cell membranes in patients submitted to gastroplasty.


Eligibility criteria:
inclusion criteria: * patients between bmi 40-50 kg/m2 exclusion criteria: * patients with bmi under 40 kg/m2 and over 50 kg/m2 * alcohol users * illicit-drug users * patients in regular use of anti-depressants, proton bomb inhibitors or calcium canal blockers * patients transfused either recently, during the intra-operative period or within 10 hours post-operative * patients previously known to be hypersensitive to any drug that is used during the study * patients with any psychiatric disorder or dementia

Keywords: morbid obesity general anaesthesia propofol sevoflurane
a study of elotuzumab in combination with pomalidomide and low dose dexamethasone and elotuzumab in combination with nivolumab in patients with multiple myeloma relapsed or refractory to prior treatment with lenalidomide.

Conditions: Multiple Myeloma

Summary: study of elotuzumab in combination with pomalidomide and low dose dexamethasone (epd cohort) and elotuzumab in combination with nivolumab (en cohort) to assess the safety and efficacy of these combination therapies for treatment of relapsed or refractory mm patients.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: 1. all subjects must have documented disease progression per imwg criteria during or after their last anti-myeloma therapy. 2. ecog performance status less than or equal to 2 3. subject re-enrollment: this study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, has not been treated). if re-enrolled, the subject must be re-consented. 4. epd cohort: * must have received at least 1 but no greater than 2 prior lines of therapy (note: induction and stem cell transplants with or without maintenance therapy is considered 1 line of therapy) * subjects must have received prior treatment with a lenalidomide-containing regimen for at least 2 consecutive cycles (full therapeutic dose) and must have been deemed as relapsed, refractory, or intolerant. refractory is defined as progressing on-treatment or within 60 days of the last dose. 5. en cohort: * subjects must have received at least 3 prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory (imid) agent or were double-refractory to both an imid and a pi. refractory is defined as progressing on-treatment or within 60 days of the last dose. exclusion criteria: 1. subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cells dyscrasia 2. subjects with monoclonal gammopathy of undetermined significance (mgus), smoldering multiple myeloma (smm), primary amyloidosis, waldenstrom's macroglobulinemia, or poems syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 3. subjects with central nervous system involvement with multiple myeloma other protocol defined inclusion/exclusion criteria could apply.