Kornimate/medical-research-clean huggingface dataset:
assessment of patient satisfaction program "gestational diabetes"

Conditions: Gestational Diabetes

Summary: this study seeks to evaluate patient satisfaction within the patient therapeutic education program "gestational diabetes" (multidisciplinary and multi-professional program) to see if they deem effective to limit the impact of gestational diabetes on pregnancy . patients are questioned on the skills acquired in everyday life, the effective support in personal development, development of self-determination capabilities and communication with health professionals. this study must include all patients participating in the therapeutic education program for a year and meeting the inclusion criteria.


Eligibility criteria:
inclusion criteria: * pregnant women * gestational diabetes diagnosis based on ogtt glucose 75g, performed after 24 weeks of gestation * women aged 18 and over * after 24th week of gestation * before 36th week of gestation * initial management in therapeutic education at the university hospital of caen exclusion criteria: * another form of diabetes (existing before pregnancy or diagnosed before 24 weeks of gestation) * women under 18 years * initial management of gestational diabetes by health professionals outside the university hospital of caen * poor understanding of the french language

Keywords: gestational diabetes patient education patient satisfaction
decision support for parents receiving information about child's rare disease

Conditions: Disorder of Sex Development; Intersex Conditions; Congenital Adrenal Hyperplasia; Hypospadias

Summary: the birth of a child with a disorder of sex development (dsd) is stressful for parents and members of the healthcare team. the "right" decisions about gender assignment (is it a boy? a girl?) and the best course of action (e.g., should there be surgery? what kind? when?) are not obvious. while there have been large advances in diagnostic assessments like genetic and endocrine testing, the tests do not always show what caused the dsd. and, even when the tests do reveal an explanation for the dsd, knowing what happened genetically or hormonally does not usually lead to a single "correct" treatment plan. instead, it is likely that there are different acceptable treatment options - and parents will need to make decisions based, in part, on their personal preferences, values, and cultural background. adding more stress to the situation is knowledge that many of the decisions that need to be made by parents early in a child's life are irreversible and exert life-long consequences for the child and the family. to support parents becoming actively involved in making such decisions, and to reduce the likelihood of future worry and regret about decisions that have been made, the investigators will create a decision support tool (dst). the dst will help educate families about typical and atypical sex development of the body, the process by which dsd are diagnosed (especially how to interpret genetic test results), and possible relationships between diagnostic/genetic testing, decisions about care, and known consequences of those decisions on their child and entire family. the dst will be used by parents of young children together with their child's health care provider. the investigators will bring together a network of researchers, health care providers, representatives of patient support and advocacy organizations, and parents of children with dsd to share their experiences. participants of this network will be involved at each stage of creating the dst, revising it, and putting it into practice. at the end of this project, the investigators will have a fully formed dst that will be available for parents to use with their child's healthcare team as they are first learning their child may have a dsd.


Eligibility criteria:
inclusion criteria: * must be a parent/caregiver of a patient who is newborn through 5 years old (i.e., 5.9 yrs). * patient clinical diagnosis of ambiguous genitalia (eg, 46,xx,prader 2+; proximal hypospadias with uni/bilateral undescended testes) or sex chromosomes discordant with genital phenotype. * condition must be newly ascertained where decisions regarding surgical procedures (internal or external genitalia), diagnostic testing, and/or other aspects of clinical management have yet to be made. exclusion criteria: * turner syndrome, klinefelter syndrome, bladder or cloacal exstrophy.

Keywords: disorder of sex development intersex 46,xx congenital adrenal hyperplasia hypospadias decision support tool
prevalence of hypogonadism in male cancer patients

Conditions: Cancer; Hypogonadism

Summary: cancer and its complications are common problems. in most cases, this condition has a profound impact on survival and quality of life (qol). fatigue, sexual dysfunction, decreased sexual drive, depression and poor appetite are commonly seen in these patients. however, these symptoms also are seen in men with other conditions including those with low testosterone levels. the objective of this study is to determine the number of male patients with cancer that have low testosterone levels and to establish the relationship between testosterone levels and the symptoms that these patients experience.


Eligibility criteria:
inclusion criteria: 1. male subjects ≥ 18 years of age with histological diagnosis of cancer for cancer group. 2. provide written informed consent prior to screening. 3. histological diagnosis of cancer other than non-melanoma skin cancer for the two cancer groups. exclusion criteria: 1. concomitant use of gh, megestrol, marinol, or any other anabolic agent, appetite stimulant (including corticosteroids other than dexamethasone at the time of iv chemotherapy administrations), tube feedings, or parenteral nutrition during the 3 months prior to entering the study. 2. participation in a clinical trial with investigational agents within 1 month of enrollment. 3. prior or current use of other medications that interfere with gonadal axis (androgens, estrogens, anti-androgens, etc).

Keywords: cancer hypogonadism testosterone cachexia
combined analysis of inflammatory biomarkers for cns autoimmune diseases diagnostic

Conditions: Central Nervous System Diseases

Summary: project rationale: since 2017, multiple sclerosis diagnosis should match the new mcdonald criteria in which a "no better explanation than ms" should be fulfilled. however, many patients present with red flags that lead to a complex diagnostic work-up. there are no available biomarkers that permit to confirm or roll out ms diagnosis in such cases. therefore, we lack biological markers that can help in the diagnosis of patients presenting with suspected ms. many studies have found that serum and cerebrospinal fluid (csf) cytokines could help to differentiate ms from other diseases such as neuromyelitis optica spectrum disorders (i.e., il-6) or neurosarcoidosis (i.e., sil-2r). serum and csf kappa free light chains have also shown good diagnosis performance in ms. in daily practice, our ms tertiary center already perform the analysis of csf concentrations of il-1β, sil-2r, il-6, il-10, and serum and csf kappa and lambda free light chains to roll out other central nervous system (cns) autoimmune diseases in patients presenting with white matter hyperintensities (wmh). objective: to correlate csf il-1β, sil-2r, il-6, il-10, serum and csf kappa and lambda free light chains with the final diagnosis in patients presenting to our ms tertiary center with suspected ms to identify a specific inflammatory biomarker profil involved in ms and other cns autoimmune diseases. the methodology: this is an observational study. all patients ongoing a routine diagnostic work-up for suspected ms from june 2020 to june 2022 in our ms tertiary center will be analyzed. cerebrospinal fluid il-1β, sil-2r, il-6, il-10, serum and csf kappa and lambda free light chains will be correlated with the final diagnosis to ultimately find ms associated biomarkers.


Eligibility criteria:
inclusion criteria: * patients referred to our center for the diagnostic work-up of white matter lesions * patients that need a routine blood analysis * patients that need a routine csf analysis * non opposition to research consent exclusion criteria: * patients with a contraindication to perform spinal tap (increase bleeding risk medicine or disease) * patients with a contraindication to mri (metal prosthesis...)
emotion/behavior problems, neuropsychological functioning, and parental adjustment in children with epilepsy

Conditions: Epilepsy

Summary: this study aims to investigate characteristics and prevalence of emotion/behavior problems in child and adolescents with epilepsy; to identify the associated factors and their effects on these children/adolescents; and to examine their attention by using conners' continuous performance test (cpt).

child and adolescents with epilepsy often have comorbid conditions such as emotion/behavior problems and attention deficit, which usually result in great impact on their individual functioning and their family. neurological factors (e.g. central neural system disease, mental retardation, and epilepsy factors), demographic factors (low socioeconomic, age, gender), family factors, child's attitude to epilepsy, parental psychopathology and their attitude may associate with the presentation of behavior and attention in child and adolescents with epilepsy. in addition, these risk factors may affect via some pathways. previous studies were conducted mainly in caucasians, and few researches were conducted in chinese population. furthermore, previous studies demonstrated inconsistent findings regarding the related risk factors for epilepsy. therefore, it is important to conduct a study investigating systematically the potential risk factors for epilepsy. this is a cross-sectional and hospital -based study. the participants include 80 child and adolescents who are 6 to 18 years old and 80 control subjects. the instruments include the chinese version of child behavior checklist (cbcl), 36-item short form health survey (sf-36), child attitude toward illness scale (catis), the swanson, nolan, and pelham, version iv (snap-iv), parental bonding instrument (pbi), family apgar, chinese health questionnaire (chq-12), impact of childhood illness scale, drug compliance scale. we will also collect related information from chart record, and then analyze for emotion/behavior presentation and to identify the risk factors for epilepsy. we expect that this study will reach the following objectives: 1. to understand the characteristics and prevalence of emotion/behavior problems and attention deficit hyperactivity syndrome in child and adolescents with epilepsy. 2. to investigate significant risk factors and the possible pathogenic pathway 3. to refer child and parents who have emotion problems 4. to combine research and service across departments (departments of neurology and psychiatry ) 5. to improve worldwide understanding of epilepsy by the results of this study

Eligibility criteria:
inclusion criteria: * children and adolescents had the clinical diagnosis of epilepsy * their ages range from 6 to 15. exclusion criteria: the subjects will be excluded from the study if they have: * chromosomal disorders * hereditary metabolic disorders * neurodegenerative disease * brain tumor; and * brain injury.

Keywords: epilepsy attention emotion behavior problems child adolescent
preloading to prevent hypotension during cesarean section

Conditions: Obstetric Anesthesia Problems

Summary: whether the usage of non-invasive arterial blood pressure monitor to guide fluid therapy in caesarean section can effectively reduce the incidence of hypotension and fetal complications.

spinal anesthesia in the cesarean section often causes significant peripheral vascular dilatation, decreases blood pressure and cardiac output reduction which leads to maternal nausea, vomiting, dizziness and uteroplacental hypoperfusion. infusion therapy and the use of vasopressor can prevent and treat the incidence of hypotension. appropriate fluid therapy can not only maintain maternal tissue perfusion, but also reduce uteroplacental hypoperfusion. in the present study, perioperative goal directed fluid therapy is used. the non-invasive continuous hemodynamic monitor is used in this study, and the parameters (blood pressure (bp), stroke volume(sv), stroke volume variation (svv), cardiac output (co)) are used to determine the parameters of the blood transfusion in cesarean section as infusion guidelines. the application of clearsight system to the pre-infusion of target-guided crystalloid solution is compared with the infusion of quantitative crystalline solution in the hope of reducing the incidence of maternal hypotension, reducing the use of vasopressin, improving uteroplacental perfusion and reducing the incidence of fetal acidosis.

Eligibility criteria:
inclusion criteria: 1. 20-45 y/o parturient 2. receive spinal anesthesia (sa) or combined spinal-epidural anesthesia (csa) to undergo cesarean section exclusion criteria: 1. emergent c/s 2. bmi\>35kg/m2 3. height \ 175 cm 4. patients with major cardiovascular disease, preeclampsia or eclampsia. 5. gestational age \< 36wks 6. multiple pregnancy

Keywords: anesthesia, obstetric fluid therapy cesarean section spinal anesthesia
a study of the safety, tolerability and pharmacokinetics of single doses of pf-05180999 in healthy adults

Conditions: Schizophrenia

Summary: the purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 14 days of treatment with pf-05180999 in healthy subjects.


Eligibility criteria:
inclusion criteria: male or female of non-childbearing potential, exclusion criteria: evidence of clinically significant medical illness, history of seizures, any condition possibly affecting drug absorption

Keywords: pf 05180999 safety pharmacokinetics
evaluation of exercise, in addition to diet, in women with gestational diabetes

Conditions: Gestational Diabetes

Summary: the main objective is to evaluate the effect of therapeutic exercise program on blood glucose regulation in women with gestational diabetes mellitus (gdm) who are assigned to diet-and-exercise, compared to diet only (usual treatment). the primary outcome is the need for insulin treatment in the two groups.

in women with gestational diabetes, light to moderate daily physical activity may a useful therapeutic approach to improve the control of glycaemia and decrease the need for prescription of insulin. increased physical activity in pregnant women with gestational diabetes is expected to decrease the mother and child morbidity associated with gestational diabetes, but also to improve the general health status of the mother and the child. the objectives of this randomized trial are: * to evaluate the effect of therapeutic exercise program on blood glucose regulation in women with gdm who are assigned to diet-and-exercise protocol. * to demonstrate the feasibility of the therapeutic exercise treatment and the possibility of using the exercise program as an optional therapeutic approach for women with gdm.

Eligibility criteria:
inclusion criteria: * gestational diabetes, based on the criteria of coustan-carpenter, then on the international association diabetes pregnancy study groups (iadpsg ) exclusion criteria: * pre-existing diabetes * twins
a study of vah631 in patients with essential hypertension (factorial study)

Conditions: Hypertension

Summary: the purpose of this study is to compare the effect of the fixed combination of valsartan+hydrochlorothiazide (hctz) on blood pressure reduction with valsartan and hctz alone and whether the combination treatments are safe and well tolerated. the study aims to establish a dose response relationship for both monotherapies and the combinations. this study is being conducted in japan.


Eligibility criteria:
inclusion criteria: * essential hypertension measured by mercury sphygmomanometer * outpatients exclusion criteria: * secondary hypertension or suspected of having secondary hypertension. * a history of malignant hypertension * severe hypertension * significant heart, renal, hepatic diseases or significant cerebrovascular disorder * gout other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension, valsartan, hydrochlorothiazide
development of a niptt for detecting copy number variations

Conditions: Copy Number Variations

Summary: to collect whole blood samples from pregnant women for the purpose of developing, optimizing and evaluating laboratory-developed noninvasive prenatal test (nipt) for the detection of fetal chromosomal abnormalities of interest defined as microinsertions, microdeletions and other copy number variations (cnvs). the nipt result will be compared to the test results obtained by microarray analysis of fetal cellular material obtained by amniocentesis or chorionic villus sampling.

this is a single center specimen collection study. eligible subjects from across the usa will be referred to the single center for participation. this study will evaluate whether the test methods being developed for the detection of fetal chromosomal abnormalities of interest in maternal whole blood samples can be used in clinical practice. enrollment of study subjects will be done in two phases - an initial pilot study phase to collect samples for research and development activities, followed by a larger single-blinded sample collection phase for nipt evaluation. for both phases, study subjects will be enrolled in a prospective manner until the predetermined sample size is attained. each study subject will be asked to provide one 20ml blood sample.

Eligibility criteria:
inclusion criteria: * subject is female * subject is 18 years of age or older * subject is pregnant at no less than 10 weeks and no more than 36 weeks gestation * subject provides a signed and dated informed consent * subject has a current pregnancy in which the fetus is determined to have a chormosomal abnormality of interest (microinsertions, microdeletions and other cnvs) as determined by microarray analysis of fetal cellular material obtained by ip exclusion criteria: * subject has experienced fetal demise in the current pregnancy
major depressive disorder with mixed features

Conditions: Major Depressive Disorder

Summary: lurasidone hcl is a compound that is a candidate for the treatment of major depressive with mixed features.this clinical study is designed to test how well lurasidone works to treat major depressive disorder with mixed features.


Eligibility criteria:
inclusion criteria: subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the investigator. subject is 18 to 75 years of age, inclusive. subject has mdd (diagnosed by dsm-iv-tr, and confirmed by the structured clinical interview for dsm-iv disorders - clinical trial version \[scid-ct\]). subject is currently experiencing a major depressive episode (diagnosed by dsm-iv-tr; at least 2 weeks in duration) and two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the scid-ct modified for study d1050305): * elevated, expansive mood * inflated self-esteem or grandiosity * more talkative than usual or pressure to keep talking * flight of ideas or subjective experience that thoughts are racing * increase in energy or goal-directed activity (either socially, at work or school, or sexually) * increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments) * decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia) subject has a rater-administered montgomery-asberg depression rating scale (madrs) total score of ≥ 26 at screening and both a rater-administered and self-rated (administered by computer) madrs total score ≥ 26 at baseline. exclusion criteria: subject has axis i or axis ii diagnosis other than mdd that has been the primary focus of treatment within the 3 months prior to screening subject answers "yes" to "suicidal ideation" item 4 or 5 on the c-ssrs (at time of evaluation) at screening or baseline visit. subject has attempted suicide within the past 3 months. subject has a lifetime history of any bipolar i manic or mixed manic episode. subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the investigator.

Keywords: depression lurasidone latuda
periosteal pedicle flap versus subepithelial connective tissue graft in management of gingival recession

Conditions: Gingival Recession

Summary: gingival recession is defined as the apical shift of the marginal gingiva from its normal position on the crown of the tooth to levels on the root surface beyond the cemento-enamel junction (cej).various surgical procedures including repositioned flaps as well as autogenous and other type grafts have been used in the treatment of gingival recession.the present gold standard technique is the bilaminar technique using the subepithelial connective tissue graft (sctg) which provides for long-term stability but also increases tissue morbidity.hence, a suitable alternative technique - the periosteal pedicle flap (ppf) - has been practiced, which is less invasive, does not require a second surgical site, and provides a graft of adequate dimensions.


Eligibility criteria:
inclusion criteria: * patients with one or more miller's class 1 and class ii buccal recessions demonstrating ≤20% of plaque and bleeding scores, respectively, after phase i therapy. * age from 18 th 60 years. exclusion criteria: * smokers * patients with malposed or crowded teeth * pregnant and lactating women * patients using medications that could affect the periodontal status
f18 dcfpyl pet/ct in imaging participants with recurrent prostate cancer

Conditions: Prostate Adenocarcinoma; PSA Level Greater Than 0.2; PSA Level Greater Than or Equal to Two; PSA Progression; Recurrent Prostate Carcinoma

Summary: this study provides fluorine f 18 dcfpyl positron emission tomography/computed tomography (pet/ct) to participants with prostate cancer that has come back. diagnostic procedures, such as fluorine f 18 dcfpyl pet/ct, may help find and diagnose prostate cancer and find out how far the disease has spread.

primary objectives: i. to evaluate fluorine f 18 dcfpyl (18f-dcfpyl) pet/ct for detection of recurrent prostate cancer after initial therapy in patients with elevated prostate-specific antigen (psa). outline: participants receive fluorine f 18 dcfpyl intravenously (iv). after 60-120 minutes, participants undergo whole body pet/ct. immediately after the first scan, participants may undergo a second pet/ct without receiving fluorine f 18 dcfpyl. after completion of study, participants are followed up at 24-72 hours.

Eligibility criteria:
inclusion criteria: * biopsy proven prostate adenocarcinoma * rising psa after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy) * post radical prostatectomy (rp) - american urological association (aua) recommendation * psa greater than 0.2 ng/ml measured after at least 6 weeks from radical prostatectomy * confirmatory persistent psa greater than 0.2 ng/ml (total of two psa measurements greater than 0.2 ng/ml) * post-radiation therapy - american society for radiation oncology (astro) - phoenix consensus definition * a rise of psa measurement of 2 or more ng/ml over the nadir * able to provide written consent * karnofsky performance status of \> 50 (or eastern cooperative oncology group \[ecog\] / world health organization \[who\] equivalent) exclusion criteria: * unable to provide informed consent * inability to lie still for the entire imaging time * inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) * any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance