Kornimate/medical-research-clean huggingface dataset:
personalized genomics for prenatal abnormalities screening using maternal blood

Conditions: Prenatal Disorder; Aneuploidy

Summary: this project aims to provide high- quality evidence to inform decisions by health care organisations about using first-tier non-invasive prenatal screening (nips) to replace traditional screening tests for trisomy 21, and potentially to screen for other fetal chromosome anomalies. we will compare the current screening approach of second-tier nips with the use of first-tier nips in a large cohort of pregnant women.

there is some data on the performance of nips as a first tier screening test but our systematic review has shown that no trial comparing the effectiveness (utility) of 2nd-tier nips with that of first-tier nips has been published . further it is important for health care decision makers to have evidence produced in canada since the geographical context of healthcare can affect uptake as well as patient decision and thus their healthcare trajectories. there is a need for a trial that is between an explanatory trial and a pragmatic trial to provide the types of answer that we aim to document in the present state of knowledge on nips-based screening strategies in canada. our objective is to perform a pan-canadian large-scale comparative utility (clinical outcomes) study of first-tier nips (expanded or not) as compared to the new standard of care (nips as a 2nd tier test performed much later during pregnancy and only in high risk pregnancies).

Eligibility criteria:
inclusion criteria: * pregnant women 19 years or older wanting prenatal screening * 10-13+6 wks determined by dating ultrasound or last menstrual period. * not intending to pursue self pay nipt exclusion criteria: * known fetal anomaly at the time of recruitment * multiple gestation * known twin demise * planned cvs or amnio for known genetic condition.

Keywords: real life comparative effectiveness non-invasive prenatal screening fetal aneuploidy randomized controlled trial
integrated care pathway in oncology (passion)

Conditions: Colon Cancer; Gastric Cancer; Pancreatic Cancer; Thoracic Neoplasms; Breast Cancer; Ovarian Cancer; Bladder Cancer; Prostate Cancer

Summary: a centralized unit for integrated management of care pathway in oncology has been created. this unit settles the patients' appointments (biopsy, intravenous device, chemotherapy, imaging, oncologist...). the aim of this study is to assess the delay between the first appointment with the oncologist and the beginning of the antitumoral treatment, and therefore evaluate the efficacy of the care pathway unit. the second aim is to assess the satisfaction of patients and health care teams.

passion is a french monocentric study. for the retrospective cohort, patient will be selected through the use of data warehouse available on the hegp. for the prospective cohort, patient will be included according to the selection criteria. each patient will be followed up during 6 month and a satisfaction questionnaire will be completed at 1 month and 4 month of the first administration of anti-tumor therapy. for both cohort, clinical-anatomo-biological data will be collected through the use of data warehouse available on the hegp.

Eligibility criteria:
inclusion criteria: * histologically proven : colon, gastric, pancreatic, prostate, bladder, breast, thoracic, or ovarian cancer * first appointment for cancer care at the hôpital européen georges pompidou * intravenous antitumoral treatment exclusion criteria: * medical care non covered by social welfare * radiochemotherapy * death in the 6 months following first oncological appointment or absence of medical care in the year following the first oncological appointment

Keywords: care pathway satisfaction oncology treatment delay
safety and efficacy of single agent obatoclax mesylate (gx15-070ms) followed by a combination with rituximab for previously-untreated follicular lymphoma (fl)

Conditions: Lymphoma, Follicular

Summary: defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. obatoclax is designed to restore apoptosis through inhibition of the bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

this is a multi-center, open-label, phase ii study of obatoclax administered alone as a weekly, 3-hour or 24-hour infusion for 12 weeks followed by a combination with rituximab to patients with previously-untreated follicular lymphoma. for purposes of clinical evaluations, treatment cycles will occur in 4-week periods. treatment may be administered on an outpatient basis. no investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.

Eligibility criteria:
inclusion criteria: * pathological confirmation of follicular lymphoma (fl) * must have advanced stage disease * must not have received any prior chemotherapy or immunotherapy for lymphoma, including steroids * must have adequate organ function * must have the ability to understand and willingness to sign a written informed consent form exclusion criteria: * no other agents or therapies administered with the intent to treat malignancy * uncontrolled, intercurrent illness * pregnant women and women who are breast feeding
study of blood samples in patients with breast cancer

Conditions: Breast Cancer

Summary: rationale: studying the genes expressed in samples of blood from patients with cancer may help doctors identify biomarkers related to cancer. it may also help doctors predict how patients will respond to chemotherapy. purpose: this clinical trial is studying blood samples in patients with breast cancer.

objectives: * identify constitutional gene variants associated with a change in response. outline: blood samples are collected periodically for analysis of genetic factors.

Eligibility criteria:
disease characteristics: * histologically confirmed breast carcinoma * received first-line chemotherapy (in neoadjuvant or metastatic setting) comprising anthracyclines and/or taxanes, including for a second primary cancer * patient agrees to conservative surgery * hormone receptor status not specified patient characteristics: * menopausal status not specified * no contraindication for chemotherapy comprising anthracyclines and/or taxanes prior concurrent therapy: * see disease characteristics * no prior adjuvant therapy

Keywords: recurrent breast cancer stage ia breast cancer stage ib breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer
topical lidocaine for pain control with intrauterine device (iud) insertion

Conditions: Pain

Summary: intrauterine contraception is a very effective, long term, reversible form of birth control, and is increasingly used in young, nulliparous patients. however, there is potential for pain with insertion of an intrauterine device (iud) - particularly in patients without a previous history of vaginal delivery. the potential pain associated with insertion is often a significant barrier for patients when choosing and iud for contraception. several methods of pain control have been studied, but none have been shown to reduce pain at time of insertion. our research question is to determine if 2% topical lidocaine gel, instilled into the cervical canal, will reduce maximum pain at time of insertion of a popular iud (mirena intrauterine system) in young, nulliparous patients. this will be studied in a randomized, double-blind placebo-controlled trial.

the investigators research question is to determine if 2% topical lidocaine gel, instilled into the cervical canal, will reduce maximum pain at time of insertion of a popular iud (mirena intrauterine system) in young, nulliparous patients. this will be studied in a randomized, double-blind placebo-controlled trial.

Eligibility criteria:
inclusion criteria: * must be at least 18 years old exclusion criteria: * age \<18 * non-english speaking * illiterate * history of pregnancy with delivery \>20 weeks * history of prior iud insertion or attempt

Keywords: intrauterine device
the use of telerehabilitation to improve motor skills and participation in children with developmental disorders

Conditions: Developmental Coordination Disorder; Telerehabilitation; Exercise; Occupational Therapy

Summary: this randomized controlled trial aimed to compare the effects of a traditional sensory-based intervention and a telerehabilitation-based sensory intervention in children aged 3-7 years diagnosed with developmental coordination disorder (dcd). participants were randomly assigned to either face-to-face or combined face-to-face and telerehabilitation groups. the outcome measures included occupational performance, sensory processing, and functional independence. the study was conducted with ethical approval, and informed consent was obtained from all legal guardians.

this single-blind, parallel-group randomized controlled trial aimed to compare the effects of a traditional face-to-face sensory-based intervention and a telerehabilitation-based sensory intervention in children aged 3-7 years diagnosed with developmental coordination disorder (dcd). a total of 22 participants were randomized into two groups: the sensory-based intervention (sbi) group and the telerehabilitation-based sensory intervention (tbsi) group. the sbi group received weekly 40-minute in-person sessions for 8 weeks. the tbsi group received the same 8-week in-person intervention followed by 8 weeks of weekly 30-minute telerehabilitation sessions delivered via zoom. both interventions included structured sensory activities tailored to each child's developmental level. primary and secondary outcomes were measured before and after the intervention using the canadian occupational performance measure (copm), the dunn sensory profile parent questionnaire, and the functional independence measure for children (weefim). the study followed consort guidelines and ethical approval was obtained. written informed consent was provided by all legal guardians.

Eligibility criteria:
inclusion criteria: * having a neurodevelopmental disorder with a confirmed diagnosis of one of the following: autism spectrum disorder, intellectual disability, developmental delay, communication disorder, or attention deficit hyperactivity disorder (adhd) * absence of any condition that may interfere with cooperation during the study * receiving occupational therapy training for a duration between 3 months and 1 year to ensure group homogeneity in terms of prior therapy experience exclusion criteria: * presence of any visual or hearing impairment that could affect study outcomes * having any systemic disease * having a physical disability that may interfere with movement or motor function
recovery rate in secondary hypothyroidism

Conditions: Secondary Hypothyroidism

Summary: the aim of this project is to assess the rate of recovery of secondary hypothyroidism in patients with pituitary disorders.

the study will be conducted in three stages. stage 1 ( patient identification and enrollment) we will generate a list of all sht patients from the hnp database and all patients will be contacted by the principal investigator (or their designate) regarding the study. those patients who agree to participate in the study will be given a written consent form. we aim to enrol approximately 90 -100 patients for the study. laboratory samples for serum tsh and t4 levels will be collected to confirm that all patients are adequately replaced for sht. those patients who are not adequately replaced and have low t4 will be excluded from the study. stage 2 (t4 withdrawal protocol) stepwise t4 replacement therapy will be initiated as follows. step 1: * reduce the dose of t4 therapy by 50% and recheck serum t4 after 2 weeks. * if serum t4 is normal, go to step 2. * if serum t4 drops to below normal then resume full t4 replacement (these patients will be considered as having withdrawal failure). the rationale for testing serum t4 after 2 weeks is that the half life of t4 is up to 7 days and early testing will potentially give false results. furthermore, serum t3 is not a reliable test in patients taking t4 therapy and will not be requested 6. step 2: * discontinue t4 therapy altogether and recheck serum tsh and t4 after 2 weeks. * if serum t4 is normal, go to step 3. * if serum t4 drops to below normal then resume full t4 replacement (these patients will be considered as having withdrawal failure). step 3: * recheck serum tsh and t4 after 8 weeks. * if serum tsh and t4 levels are normal, these patients will be regarded as having successful t4 withdrawal. * if t4 drops to below normal then resume full t4 replacement (these patients will be considered as having withdrawal failure). stage 3 (analysis)

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of secondary hypothyroidism who are currently taking t4 replacement therapy exclusion criteria: * uncontrolled cardiovascular disease * uncontrolled congestive heart failure * uncontrolled mental health disorder * not adequately replaced and have low t4 level.
pcos immune function predicts metformin efficacy

Conditions: Polycystic Ovary Syndrome; Metformin; Immune Function

Summary: in this study, the investigators will include pcos patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. the immune function of peripheral blood samples of pcos patients was detected by flow cytometry. participants were further treated with metformin for 6 months and followed up after the intervention. the objective of this study was to investigate immune markers related to the efficacy of metformin in pcos patients and to predict the efficacy of metformin in pcos patients using immune function.

in this study, peripheral blood samples of pcos patients were collected before and after intervention. flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and fluorescently labeled antibodies in human peripheral blood, and the unlabeled cells were dissolved. the number and percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.

Eligibility criteria:
inclusion criteria: * aged 18-45 years * diagnosis of pcos with the rotterdam diagnosis criteria (2003) exclusion criteria: * pregnant women; * hyperthyroidism or hypothyroidism * severe liver and kidney function injury * cancer patients; * associated with severe infection, severe anemia, neutropenia and other blood system diseases; * have type 1 diabetes, single-gene mutated diabetes or other secondary diabetes; * patients with mental illness or intellectual disability; * have taken drugs for pcos treatment in the last three months; * have a long history of taking hormone therapy; * currently or recently participating in another clinical trial.
hydrocortisone for term hypotension

Conditions: Infant, Newborn, Diseases; Cardiovascular Insufficiency

Summary: this trial will evaluate the effects of a 7-day course of hydrocortisone therapy on short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.

cardiovascular insufficiency is common and potentially life-threatening in critically ill term and late preterm newborns admitted to the newborn intensive care unit (nicu) in the first few days of age. this study proposes to conduct a multicenter, randomized, masked, placebo-controlled trial within the neonatal research network (nrn). this trial will evaluate the effects of a 7-day course of hydrocortisone therapy on short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.

Eligibility criteria:
inclusion criteria: * gestational age greater than or equal to 34 weeks at birth * admitted to the center nicu by 48 hours of age * intubated and mechanically ventilated for a minimum of 2 hours before 72 hours postnatal age exclusion criteria: * receiving ecmo * intubated for the sole purpose of anticipated surgery or airway anomalies * treatment will be limited based on poor prognosis * receiving dexamethasone or hydrocortisone * receiving ibuprofen or indomethacin * congenital heart disease * hypotension thought to result from specific, immediately remediable factors including placental hemorrhage, acute hemorrhage or tension pneumothorax * pituitary hypoplasia or congenital adrenal hyperplasia * any chromosomal disorder * hypertension in the absence of inotrope therapy as defined by mean arterial blood pressure \> 95th percentile * initiation of whole body cooling for moderate or severe neonatal encephalopathy * brain disorders or any other known structural abnormality * major anomalies

Keywords: nichd neonatal research network mechanical ventilation intubation neurodevelopmental impairment
a biopsychosocial treatment for exhaustion due to persistent non-traumatic stress

Conditions: Exhaustion Disorder; Clinical Burnout

Summary: currently, there are no established theoretical models for developing and maintaining exhaustion due to persistent non-traumatic stress (ents). therefore, the current pilot study aims to evaluate a multimodal hybrid intervention built around an internet-delivered cognitive behavioral therapy based on a new biopsychosocial treatment model of ents.

since 2009 long term sick-leave rates due to mental disorders have been increasing in sweden and are today the leading cause of long-term sick leave. exhaustion due to persistent non-traumatic stress (ents) accounts for most of this increase. unfortunately, despite several published treatment studies, no evidence-based treatments exist for ents, and little is still known about the focus of treatment. currently, there are no established theoretical models for the development and maintenance of ents. many of the published clinical ents trials consist of long (6 months or more) multimodal interventions (mmi) containing various medical, psychological, and physiotherapeutic methods with a low degree of understanding of what components are critical for treatment success. even if ents patients participating in mmi report symptom improvements and work resumption, mmi is generally personnel intensive and challenging to administer. these factors increase the risk of extended healthcare lead times and obstruct treatment dissemination. considering the increasing sick-leave rates due to ents, there is an apparent need for more accessible treatments based on pronounced theoretical models focusing on specific change processes. therefore, the current pilot study aims to evaluate a hybrid mmi built around an internet-delivered cognitive behavioral therapy based on a new biopsychosocial treatment model of ents. outcome measures will be collected before and after treatment and at three and six-month follow-ups. weekly measurements of putative processes of change will also be collected. the current study aims to evaluate whether this more restricted and theoretically coherent hybrid mmi shows promising results before we test the treatment solely as a cognitive behavioral therapy via the internet in a randomized controlled trial.

Eligibility criteria:
inclusion criteria: * referred for stress-induced exhaustion disorder (sed) * fulfilled the criteria for sed * scored \> 5 on the shirom-melamed burnout questionnaire (a cut-off determined by the health care services stockholm county) * scored 19 \> on karolinska exhaustion disorder scale * in need of sick-leave due to sed d) access to internet exclusion criteria: * 100 % sick leave of more than one year * abuse of alcohol or drugs * participating in any other form of mmi * severe depression, moderate/high risk of suicide, psychosis, or untreated ptsd.
parkinson's disease genetics database

Conditions: Parkinson's Disease

Summary: the goal of the study is to develop and organize an effort to identify genes that determine an individual's risk for developing parkinson's disease (pd). 1. to ascertain, study and establish a repository of dna samples that will allow for the identification of known and yet-to-be-identified genetic markers associated with the development of pd. 2. to create a database with clinical, genetic (hla, genome screen) and medical history information that will facilitate the search for pd susceptibility genes. 3. to provide a centralized dna repository to allow for targeted studies of genetic factors contributing to the onset, heterogeneity and progression of pd. 4. to evaluate opportunities to extend the results of research to develop methods of risk prediction, prevention and therapy for pd.


Eligibility criteria:
inclusion criteria: * subjects must have a diagnosis of parkinson's disease as determined by standard neurological criteria. * patients ≥18 years of age who are able to provide informed consent * patients ≥ 18 who are decisionally impaired for whom informed consent can be obtained by a legally authorized representative. exclusion criteria: * patients without a diagnosis of parkinson's disease.
the protective effects of sevoflurane in pediatric cardiac surgery

Conditions: Congenital Heart Diseases

Summary: during repair of a congenital heart defect the child is exposed to myocardial hypoxia. recent studies have suggested that the paediatric myocardium is more sensitive to hypoxia and cardioplegic arrest than the adult. the protective effect of halogenated agents on ischaemia and reperfusion injury has been investigated widely in adults. the investigators hypothesis that sevoflurane applied during cardiopulmonary bypass might afford better myocardial protection during paediatric cardiac surgery.


Eligibility criteria:
inclusion criteria: * pediatric patients (body weight \< 10 kg) * diagnosed with congenital heart diseases * scheduled for repair operation with cpb * in the department of cardiovascular surgery, xijing hospital exclusion criteria: * systemic infections * other systemic diseases

Keywords: congenital heart diseases cardiopulmonary bypass pediatric sevoflurane