Kornimate/medical-research-clean huggingface dataset:
efficacy study of paliperidone to evaluate subjective change in well-being and drug attitude in schizophrenic participants

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate improvement and efficacy of paliperidone extended-release for subjective well-being and drug attitudes of participants, when switching from oral antipsychotics in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

this is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), prospective (study following participants forward in time), and non-comparative study, in participants with schizophrenia. the study consists of following parts: screening (that is, 14 days before study commences on day 1); acute treatment phase (24 weeks); extension phase 1 (24 weeks), which will be followed by additional extension phase 2 (48 weeks). total study duration per participant will be 96 weeks. efficacy will primarily be evaluated by change from baseline in subjective well-being under neuroleptic (swn-20) scale score and change from baseline in drug attitude inventory scores. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants who are diagnosed with schizophrenia (diagnosis criteria: diagnostic and statistical manual of mental disorders, fourth edition \[dsm-iv\]) * participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening-lack of efficacy, lack of tolerance or lack of compliance * participants who are capable of and willing to fill out the questionnaire for themselves * childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) * participants who are compliant with self-medication or can receive consistent help or support exclusion criteria: * participants with the past history of neuroleptic malignant syndrome (nms), or with allergy or hypersensitivity to risperidone or paliperidone * participants who have taken clozapine within one month before screening * participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment) * participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot swallow the drug whole (the study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile) * participants with a known or suspected history (for 6 months and longer) of substance dependence according to the dsm-iv criteria

Keywords: schizophrenia paliperidone extended-release paliperidone r076477
alkaline phosphatase level in pregnancy and its association with birth weight

Conditions: Low Birth Weight Infants

Summary: alkaline phosphatase is known to be produced by syncytiotrophoblasts in the placenta and its levels are normally increased in pregnancy. therefore, it would be reasonable to hypothesize that alkaline phosphatase would be low to low normal in cases of low birth weight / intrauterine growth restriction (iugr)/ placental insufficiency.

the purpose of this study will be to determine if alkaline phosphatase can be used as a predictor for suboptimal fetal growth, placental insufficiency and low birth weight (birth weight less than 2500 grams). it will also help determine if alkaline phosphatase can be used as a screening tool for low birth weight/iugr at the time of the 24 to 28 week labs.

Eligibility criteria:
inclusion criteria: • patients enrolled between 24w0d and 28w6d weeks gestational age will be included. the blood specimen of the patients enrolled will be held until delivery. exclusion criteria: * multiple gestations * known congenital malformations (any, except pyelectasis) * chronic hypertension * inflammatory bowel disease (ibd) * gall bladder disease * active bone disease (ie, skeletal dysplasia, healing fracture) * active liver disease (ie, hepatitis, cholestasis, cholelithiasis (gallstones)) * pre-existing type 1 and 2 diabetes * early-onset iugr

Keywords: alkaline phosphatase pregnancy suboptimal fetal growth placental insufficiency low birth weight iugr
weight stigma in women who are obese: assessing how an acute exposure to stigma negatively impacts cardiovascular health

Conditions: Stigma, Social; Obesity; Cardiovascular Disease Risk Factor; Blood Pressure

Summary: the current study examined the influence of an acute weight stigma exposure on cardiovascular reactivity among women with obesity and high blood pressure and women with obesity and normal blood pressure.

the current study examined the influence of two video exposures, one containing scenes of weight stigma (stigma) and the other non-stigmatizing neutral (neutral) scenes, on cardiovascular reactivity as assessed by resting bp and ambulatory blood pressure (abp) and heart rate (hr), among women with obesity and high bp (hbp) or normal bp (nbp). the investigators hypothesized that as a result of stigma compared to neutral, cardiovascular reactivity would be significantly greater immediately upon watching the video and persist outside of the laboratory over ambulatory conditions in women with obesity and hbp compared to women with obesity and nbp.

Eligibility criteria:
inclusion criteria: * premenopausal * bmi \> 30 kg/m2 * no other known chronic cardiovascular or metabolic diseases besides hypertension exclusion criteria: * pregnant or planned on becoming pregnant * took medications that may have affected the primary outcome of bp (e.g., stimulants for attention deficit hyperactivity disorder or steroids for asthma) * currently using tobacco products * diagnosed with an eating disorder
long-term safety and efficacy of abt-126 in subjects with schizophrenia: an extension study for subjects completing study m10-855 (nct01655680)

Conditions: Schizophrenia

Summary: this is a study of abt-126 in the treatment of cognitive impairment associated with schizophrenia (cias), a long-term extension study to study m10-855 (nct01655680).


Eligibility criteria:
inclusion criteria: * the subject was randomized into study m10-855 and completed through week 26 in that study. * the subject is receiving one or more antipsychotic medications. exclusion criteria: * additional history collected during participation in study m10-855 provides evidence that, in the investigator's judgement, the subject does not have schizophrenia. * the subject experienced an adverse event or abnormal finding during physical examination, vital signs, laboratory profile, and/or electrocardiogram (ecg) measurements in study m10-855 that indicates the subject is likely to become medically unstable during the current study. * the subject is currently taking or is expected to be prescribed any excluded medication without the approval of abbvie medical monitor. * the subject is currently enrolled in, or plans to participate in, another interventional study during the course of this trial.

Keywords: schizophrenia
study of adding entecavir to current lamivudine therapy in hiv and hbv co-infected patients

Conditions: Hepatitis B

Summary: the purpose of this clinical research study is to assess the safety and effectiveness of entecavir, when being added to lamivudine, in the treatment of adults with chronic hepatitis b infection who are co-infected with hiv.


Eligibility criteria:
* documented history of co-infection with hiv and hbv * stable anti retroviral therapy regimen containing lamivudine 150 mg bid for at least 24 weeks prior to enrollment; * documented hbv viremia on screening and at least at 4 weeks prior to screening * hbe ag-positive or hbe ag-negative / anti-hbe-positive * hiv viral load below 400 copies/ml by the roche amplicor(tm) 1.5 hiv pcr assay at screening and equally low at least 12 weeks prior to screening * absence of co-infection with hepatitis c virus (hcv) or hepatitis d virus (hdv) * absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease * less that 1/2 weeks of prior therapy with nucleoside/nucleotide analogue (excluding lamivudine) with activity against hbv (including e.g. famciclovir, tenofovir, ganciclovir, adefovir). no receipt of any of these therapies within 24 weeks prior to randomization into this study.
study of biologic tumor and plasma biomarkers of response to ttfields in patients treated for newly diagnosed glioblastoma

Conditions: Glioblastoma

Summary: this trial is a translational, open-label, monocentric prospective study of 80 patients aiming to study resistance mechanisms as well as biomarkers of resistance or sensitivity to ttfields. the study will be conducted on a population of patients with newly diagnosed glioblastoma treated with radio-chemotherapy followed by ttfields in the context of either routine care or a clinical trial. in this study, the optune® system (battery operated device which delivers ttfields to the brain) will not be under investigation. for each included patient, blood samples will be collected during baseline visit (before initiation of radio-chemotherapy), then before initiation of ttfields and every 3 months during ttfields treatment. additional blood samples will be scheduled at recurrence (if applicable). moreover, tumor samples (formalin paraffin embedded (ffpe) tumor block and fresh samples) will be collected from surgery specimen on primary tumor by the sponsor for analysis. in case of recurrence, and if a second surgery is possible, tumor samples will also be collected. tumor samples will be collected from biopsies taken in the course of routine practice and from surgical specimens collected during surgical procedure. no additional biopsies will be performed for the study. patients will be followed-up for time to progression and overall survival for a maximum duration of 24 months from the ttfields initiation. mri performed by patients during the course of the study will be collected by the sponsor for additional future research purposes.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years at the time of study entry. 2. patient with newly diagnosed glioblastoma. 3. patient for which a treatment with radio-chemotherapy followed by ttfields has been decided and has not been started. 4. signed written informed consent. 5. patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol 6. patient affiliated to a social health insurance in france. exclusion criteria: 1. any condition contraindicated with sampling procedures required by the protocol. 2. any contraindication to the use of the medical device administering ttfields. 3. simultaneous participation in a therapeutic interventional clinical trial. 4. patient pregnant, or breast-feeding. 5. known history of positive test for hepatitis b virus or hepatitis c virus or human immunodeficiency virus (hiv) or known acquired immunodeficiency syndrome (aids). 6. any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure 7. patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)

Keywords: glioblastoma biologic tumor and plasma biomarkers translational research ttfields
complex regional pain syndrome (crps) and the gut-bacteria

Conditions: CRPS

Summary: the purpose of this study is to investigate, for the first time, whether gut bacteria composition and function of patients with crps differ from those of healthy adults. samples of stool, urine and blood will be collected from patients with crps and from healthy adults. the type and function of bacteria of crps patients will be analyzed and compared to those of healthy adults to test if potential differences could explain the mechanism/s involved with the development of crps.


Eligibility criteria:
inclusion criteria: 1. women and men over the age of 18, diagnosed with crps of the upper or lower limb according to the clinical budapest criteria, with a duration of 6 months and over (for the 1st study group). 2. healthy women and men over the age of 18, who share a household with a crps patients participating in the study (for the 1st control group). 3. healthy women and men over the age of 18 (for the 2nd control group). 4. be able to read and write in either french, english or hebrew. exclusion criteria: 1. any major illness (eg. malignancy, active inflammatory disease, metabolic disease, etc.) 2. pregnancy 3. chronic pain conditions (other than crps in the patients group) 4. acute illness of any type in the preceding 1 month 5. use of systemic antibiotics in the preceding 1 month 6. change in any other regularly taken medications in the past 1 month 7. substantial dietary / gastrointestinal alterations in the past 1 month. the inclusion/exclusion criteria were set to reduce the risk of confounding factors that could affect gut microbiota composition.
post market clinical follow-up of dual-mobility acetabular cup euroscup mobile

Conditions: Hip Arthropathy; Hip Osteoarthritis; Hip Arthritis; Hip Fractures; Hip Necrosis; Hip Dysplasia

Summary: euroscup mobile is intended for use in primary and revision total hip replacement surgery. hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. as part of post market vigilance, euros will collect data on euroscup mobile performances and safety

post market observational study. this study is retropective and prospective, non comparative.

Eligibility criteria:
inclusion criteria: * patient who received euroscup mobile. * patient informed of its participation to the study * patient aged between 18 and 80 years old (\<80). exclusion criteria: * patient presenting a contraindication to euroscup mobile implantation. * patient who refused to participate to the study * vulnerable subjects
remote assessment and dynamic response intervention ii

Conditions: Dementia; Alzheimer Disease; Relationship, Marital; Caregiver Stress Syndrome

Summary: the purpose of the readyr ii study is to test a dynamic tailoring phase of a remote assessment for changing dementia-related care needs.

unmet dementia-related care needs are highly prevalent, and are detrimental to the care dyad's (person with dementia and their family care partner) health, safety, mortality, and likelihood of nursing home placement. readyr ii tests a dynamic tailoring phase of an intervention program that was previously developed to remotely assess dementia-related care needs using digital data on behavioral patterns (from sensors and wearables) in the home. readyr ii follows participants who have completed readyr for a total of six months in order to detect anomalies in activity patterns that may indicate new and unforeseen care needs. people who voluntarily decide to participate in this follow-up intervention study will be asked to continue participating with the in-home monitoring sensor platform, complete weekly questionnaires, and receive regular follow-up telephone calls from the study team.

Eligibility criteria:
inclusion criteria: * 62 years or older; * able to identify a family care partner over age 20 who is living with you and will also consent to fully participate in the study * probable or confirmed diagnosis of mild cognitive impairment or early-stage dementia * age and education adjusted moca score \> 15 (at most recent measurement by parent study) corresponding to early to moderate stage dementia exclusion criteria: * inability to speak english or read printed materials in english * conditions that would limit participation at entry to study (e.g. visual or hearing impairments prohibiting reading and discussing the intervention materials) * any uncontrolled medical condition that is expected to preclude completion of the study, such as late stage cancers family care partners inclusion: * 21 years or older; * self-identifying as a family member and care partner residing with the pwd participant; exclusion: * inability to speak english or read printed materials in english * conditions that would limit participation at entry to study (e.g. visual or hearing impairments prohibiting reading and discussing the intervention materials); * any uncontrolled medical condition that is expected to preclude completion of the study, such as late stage cancers.

Keywords: needs assessment remote monitoring technology care values aging-in-place family caregiver
effects of cacao flavonoids in long covid-19 patients (flaloc)

Conditions: Long Covid19; Fatigue Syndrome, Chronic

Summary: the study use a triple blind, placebo-controlled design enrolling male and female subjects between 30-70 yo to evaluate the effect of daily consumption of a cacao supplement on inflammation, endothelial damage, handgrip strength, fatigue scale and quality of life.

the study use a triple blind, placebo-controlled design enrolling male and female subjects between 30-70 yo distributed homogeneously at random in two groups: the control group (placebo) and the intervention group (cacao flavonoids) both groups affected for 90 days. the variables to consider will be: interleukins (il-1b, il-6), tumoral necrosis factor alpha (tnf-α) and syndecan-1. for physical performance is evaluated the handgrip strength. the investigators also assessed quality of life using the health related qol (eq-5d) questionnaire, and the numerical fatigue rating scale.

Eligibility criteria:
inclusion criteria: * post-covid-19 patients, at least 6 months after symptom onset * chronic fatigue exclusion criteria: * allergy or intolerance caused by active ingredients * pregnancy or lactation * bmi \>35 * chronic liver disease * chronic kidney disease

Keywords: flavonoids post-covid
rationale and design of diabetes management with curcumin and saffron (dmcs): a randomised, three blind -blind, placebo-controlled study

Conditions: Women of Reproductive Age; Diabetes Mellitus

Summary: ## study hypotheses summary: \*\*primary hypothesis:\*\* women with diabetes mellitus receiving the intervention will exhibit significantly lower levels of sugar indicators (fbs, ha1c, 2hpp) and lipid indicators (ldl, hdl, tg) compared to the placebo group. \*\*secondary hypotheses:\*\* 1. \*\*psychological outcomes:\*\* the intervention group will show significant reductions in stress, anxiety, and depression compared to the placebo group. 2. \*\*sexual health outcomes:\*\* the intervention group will experience improvements in sexual performance, marital satisfaction, and quality of sexual life compared to the placebo group. 3. \*\*diabetes management outcomes:\*\* the intervention group will demonstrate improvements in clinical symptoms of diabetes and anthropometric index compared to the placebo group. 4. \*\*medication adherence:\*\* the intervention will be well-received by women with diabetes mellitus of reproductive age, leading to improved medication adherence.

the study is a four-arm trial testing the effectiveness of curcumin, saffron, and a combination of both compared to a placebo in women with diabetes. the trial will measure glucose and lipid levels, medication side effects, adherence to treatment, and various other health indicators at different time points. participants will be recruited from a specialty diabetes clinic in yazd province, iran, with specific eligibility criteria including age, diabetes diagnosis, and exclusion criteria such as allergies and certain medication use. the diagnostic criteria for diabetes mellitus are outlined by the american diabetes association.

Eligibility criteria:
inclusion criteria: * being married, having type 2 diabetes(according to american diabetes association provides guidelines) that had been diagnosed and treated for at least one year, not being dependent on insulin, being between the ages of 18-45 and having a body mass index between 18.5 and 30. additionally, absence of menorrhagia on the basis of the pblac chart exclusion criteria: * participants who are allergic to turmeric or saffron plant essence will be excluded from the study. additionally, women who do not regularly use supplements or take drugs for at least 7 consecutive days per month were excluded. anticoagulant use, pregnancy, and breastfeeding will be also exclusion criteria. finally, participants who had taken multivitamins or supplements affecting metabolism in the last three months will be not included in the study. exclusion criteria for the study will include changes in diet and physical activity, experiencing a stressful event during the intervention (as reported by the research unit), and the use of drugs that affect sexual performance (as reported by the research unit)

Keywords: diabetes reproductive age curcumin saffron lipid profile sugar profile enterometric indices
stratagen quantitative prostate mri platform pilot study

Conditions: Prostate Cancer

Summary: the goal of this clinical trial is to assess the safety and feasibility of the stratagen quantitative prostate mri platform when used in addition to the standard scans conducted during the existing prostate mri sessions. * what severe problems, if any, occur because of the use of the stratagen quantitative prostate mri platform? * can the data collected be used to measure quantitative mri parameters? participants will: - receive up to 15 minutes of additional mri scan time during the existing prostate mri imaging session.


Eligibility criteria:
inclusion criteria: * subject has a prostate that would be considered for biopsy * age 40-90 years * psa ≥ 2.5 * subject has been informed of the nature of the study and has provided written informed consent exclusion criteria: * contraindication for mri * prostate biopsy within the previous 12 weeks * implant in the pelvis that may cause artifact on mri (e.g. hip replacement) * history of prostatectomy or other local prostate cancer therapy (e.g., cryotherapy or brachytherapy), or previous pelvic irradiation * currently enrolled in another investigational drug or device study that clinically interferes with this study * unable to comply with the study requirements or follow up schedule * any condition the investigator believes would interfere with the intent of this study or would make participation not in the best interest of the subject