Kornimate/medical-research-clean huggingface dataset:
study to investigate dosage, efficacy, and safety of fycompa in routine clinical care of patients with epilepsy

Conditions: Epilepsy

Summary: this study is conducted to assess the retention rate of fycompa when given in routine clinical care.


Eligibility criteria:
inclusion criteria: * participants must have met all of the following criteria to be included in this study: 1. diagnosis of epilepsy 2. initiated treatment with fycompa at any time after 01 jan 2014 3. provided written informed consent by the participant or the participant's legally authorized representative signed for the use of medical records (if required by an institutional review board \[irb\] or independent ethics committee \[iec\], or by regulatory authorities). exclusion criteria: * not applicable

Keywords: seizure fycompa
changes in intravenous anesthetic drug dosage in insomnia patients undergoing digestive endoscopy

Conditions: Insomnia; Digestive Endoscopy

Summary: to compare the dosage requirement of intravenous anesthetics during digestive endoscopy between patients with insomnia and those with normal sleep pattern.

the investigators aim to investigate whether intravenous anesthetic drug dosage requirement is increased in patients with insomnia undergoing digestive endoscopy compared with normal sleep patterns.

Eligibility criteria:
inclusion criteria: * patients with insomnia: 1. age of 18 - 64 years; 2. asa physical status of i - ii; 3. bmi of 15 - 30; 4. scheduled for digestive endoscopy under intravenous anesthesia; 5. positive screening results according to the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for insomnia disorder; 6. 8-item sleep condition indicator (sci; score 0-4; range 0-32, higher score means better sleep) scored 16 or less; * patients with normal sleep: 1. age of 18 - 64 years; 2. asa physical status of i - ii; 3. bmi of 15 - 30; 4. scheduled for digestive endoscopy under intravenous anesthesia; 5. no history or evidence of insomnia. exclusion criteria: * 1. associated with any neurological disease; 2. daily alcohol consumption; 3. any contraindication to intravenous anesthetic drug, such as hypotension or shock; 4. history of allergy to any drug used in the study; 5. pregnancy or breastfeeding; 6. patients with sleep apnea syndrome; 7. acute upper respiratory infection; 8. patients with psychological diseases who report suicidal thoughts; 9. patients who need to work or take care of children/elderly people frequently at night.

Keywords: digestive endoscopy insomnia intravenous anesthetic
bep targeting strategies in ethiopia

Conditions: Small for Gestational Age At Delivery; Gestational Weight Gain; Stillbirth; Preterm Birth; Birth Weight; Maternal Anemia in Pregnancy, Before Birth; Neonatal Death; Perinatal Death

Summary: the goal of this randomized effectiveness study is to evaluate the different targeting strategies for the delivery of balanced energy and protein (bep) supplements among pregnant women in addis ababa, ethiopia. the main goals of the study are to: 1) determine the effectiveness of two individual-based antenatal bep targeting strategies for preventing adverse pregnancy outcomes; 2) compare the cost-effectiveness of the universal bep provision with two individual-based targeting strategies for preventing adverse pregnancy outcomes; and 3) generate implementation evidence regarding the feasibility and acceptability of different antenatal bep targeting strategies. pregnant women will be enrolled during pregnancy, assigned to different strategies of bep supplementation, and followed from pregnancy through six weeks postpartum to evaluate the impacts of different bep targeting strategies on pregnancy, maternal, and child outcomes.


Eligibility criteria:
inclusion criteria: 1. pregnant women aged 18 to 49; 2. attending antenatal visits in one of the study health facilities; 3. with a gestational age of 24 weeks or less; 4. no known allergies to peanuts or soybeans; 5. having resided in the current location for at least 6 months; 6. intending to continue antenatal follow-up in the health facility; 7. intending to give birth and remain in the study area until six weeks after delivery; and 8. willing to take the bep supplements for the entire duration of the pregnancy if eligible. exclusion criteria: * not meeting all of the inclusion criteria above

Keywords: balanced energy and protein supplementation food supplementation antenatal nutrition maternal nutrition gestational weight gain ethiopia
ultrasound guided intra articular injection of platelet rich fibrin versus hyaluronic acid as means of pain relief in patients with moderate degree knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: randomised controlled trial


Eligibility criteria:
inclusion criteria: * asa i, ii. * moderate knee osteoarthritis exclusion criteria: * neurological patients. * patients with uncontrolled co morbidities
to evaluate the safety and pharmacokinetics of bms-986177 in healthy japanese participants

Conditions: Thrombosis

Summary: access the safety, tolerability, and pharmacokinetics of bms-986177 in healthy japanese participants after multiple doses are administered.


Eligibility criteria:
inclusion criteria: * participants must be first-generation japanese (born in japan and not living outside of japan for \> 10 years; both parents must be ethnically japanese) * body mass index 18.0 to 25.0 kg/m2, inclusive * women must not be of nonchildbearing potential (cannot become pregnant) exclusion criteria: * any significant acute or chronic medical illness * history of allergy to bms-986177 or other factor xia inhibitors and/or formulation excipients or history of any significant drug allergy (such as anaphylaxis or hepatotoxicity) * history or evidence of abnormal bleeding or coagulation disorder other protocol defined inclusion and exclusion criteria apply
breastfeeding and complementary feeding in relation to bmi and overweight

Conditions: Child Overweight

Summary: this study examines the associations between different types of infant feeding and bmi and overweight in childhood. the study is based on the danish national birth cohort, established in 1996.

the objective of the study is to examine whether duration of breastfeeding, timing of introduction of complementary food and protein intake at 18 months are associated with bmi and overweight at ages 7 and 11 years, independent of bmi during infancy. children participating in the danish national birth cohort were followed-up at ages 7 and 11years. information on infant feeding, protein intake at 18 months, ponderal index at birth, child bmi (5 months, 12 months, 7 and 11 years) and several parental factors was available. path analysis was used to assess the direct and indirect effects of infant feeding on bmi z-scores at ages 7 (n= 36,481) and 11y (n=22,047). logistic regression analyses were used to examine associations with overweight.

Eligibility criteria:
inclusion criteria: * the women were invited at their first antenatal visit at the general practitioner.women were included if they intended to carry the pregnancy to term, had a permanent address in denmark, and spoke danish well enough to participate in telephone interviews. exclusion criteria: * women who were not pregnant.

Keywords: cohort study infant feeding overweight child bmi breastfeeding intake of protein
behavioral activation and risk reduction for stimulant use among sexually active young gay/bisexual minority men (impact)

Conditions: HIV

Summary: the use of behavioral intervention to reduce stimulant use and concurrent hiv sexual transmission risk

impact is a human immunodeficiency virus (hiv) status-neutral, behavioral intervention to reduce stimulant use and concurrent hiv sexual transmission risk. this study will evaluate the effectiveness of impact and determine feasibility of implementing impact across various settings for translation into real-world practice using a hybrid effectiveness-implementation design. the impact intervention includes 10 sessions: 2 intervention sessions of hiv risk reduction (rr), 1 session focused on orienting and rationale of behavioral activation (ba), 6 sessions integrating ba and rr-including pre-exposure prophylaxis (prep) or antiretroviral therapy (art) and hiv care-and 1 final session on relapse prevention. the enhanced standard of care (esoc) group includes two hiv rr intervention sessions.

Eligibility criteria:
inclusion criteria: * age 16-24 years, inclusive, at enrollment * assigned male at birth * identifies as a cisgender boy or man * self-reports condomless anal sex (cas) with another boy/man-receptive or insertive-while using stimulants (5 hours prior to, or during, sex) within the last 4 months; stimulants is defined as crystal methamphetamine, cocaine, and mdma (e.g., ecstasy, molly) * willing and able to provide written informed consent for study participation in addition, virtual participants must meet all the below criteria: * access to a computer/smartphone/tablet that can use video chat (e.g., zoom or google meet) * provide a mailing address where they can receive a package * access to stable internet that they can use for more than 2 hours at a time * have a private place (where no one else can see or hear) where they can complete visits online * reside within the continental u.s. exclusion criteria: * unable to provide informed consent due to severe mental or physical illness * concurrent enrollment in another hiv prevention or treatment study (enrollment in a substance treatment program is acceptable * non-english-speaking * is currently incarcerated or pending incarceration * any other medical condition, medical/behavioral intervention, or other condition that, in the opinion of the site consortium project lead or designee, could interfere with the safety of participants or staff, adherence to study procedures, or compromise interpretation of study results

Keywords: hiv sexual transmission risk behavioral activation risk reduction intervention stimulant use
association of plant-based diet and gut microbiome signature with response to neoadjuvant therapy in pancreatic ductal adenocarcinoma

Conditions: Borderline Resectable Pancreatic Ductal Adenocarcinoma; Resectable Pancreatic Ductal Adenocarcinoma; Stage I Pancreatic Cancer AJCC V8

Summary: this study explores the relationship between pre-treatment dietary patterns, fecal microbiome, and response to chemotherapy in patients with pancreatic ductal adenocarcinoma.

primary objectives: i. evaluate the association between pre-treatment diversity of the fecal microbiome and major pathological response to neoadjuvant chemotherapy in operable pancreatic ductal adenocarcinoma patients. ii. evaluate the association between pre-treatment hei-2015 dietary score and major pathological response to neoadjuvant chemotherapy in pancreatic ductal adenocarcinoma patients. iii. evaluate the association between pre-treatment hei-2015 dietary score and diversity of the fecal microbiome in pancreatic ductal adenocarcinoma patients. outline: this is an observational study. patients complete a dietary survey and undergo fecal sample collection on study.

Eligibility criteria:
inclusion criteria: * \* age ≥ 18 years with signed informed consent form * patients must have a histological diagnosis of pdac * resectable or borderline resectable pdac on imaging exclusion criteria: * \* patients with locally advanced and metastatic stage iv pdac * patients who have already received or completed neoadjuvant chemotherapy for pdac * patients with active malignancy receiving systemic therapy
ai assistant for enhancing colorectal cancer screening among first-degree relatives of patients: a randomized trial

Conditions: Colonoscopy; Colorectal Cancer; First-degree Relatives

Summary: participants in intervention group will receive the screentalk ai-based intervention consisting of 3 sessions: tailored messaging session, open dialogue session, and summary session. the primary outcome, screening uptake will be verified by medical records; and health belief will be measured at baseline, 3, 6 and 12 months.

screentalk ai can automatically tailor screening recommendations based on risk and psychosocial characteristic assessments by leveraging ai-interactive speech technology. the three components of the screentalk ai-based intervention are as follows: (1) tailored messaging session: to provide crc risk and screening recommendation based on family history and health belief assessment; (2) open dialogue session: to communicate with users asking questions related to crc risk and screening information, underpinned by the professional knowledge database and large language models; (3) summary session: to provide a picture overview for easy review. the evaluation will be guided by the re-aim. quantitative measures will determine the reach, adoption, and implementation via participation rate, session adherence, completion, satisfaction rate, fidelity and cost. screening uptake verified by medical records and health belief will be measured at baseline, 3, 6 and 12 months. qualitative interviews will be conducted to identify the factors affecting implementation and maintenance.

Eligibility criteria:
inclusion criteria: * age 40 to 75 years or 10 years before the age at which the relative was diagnosed; * individuals with one fdr with crc age \<60 years or with two or more fdrs with crc at any age; * have not had a colonoscopy within 5 years; * access to wechat themselves or through close family members living in the same household; * able to read and speak chinese. exclusion criteria: * have history of cancer or inflammatory bowel disease; * have history of a hereditary syndromes (lynch syndrome or familial adenomatous polyposis); * recently participate in another study or previously participated in cancer risk counseling or study; * with doctor-diagnosed psychiatric illness.

Keywords: colonoscopy first-degree relatives cancer screening artificial intelligence speech technology
radiotherapy with single-agent cisplatin or combination chemotherapy in defined poor-prognostic cervical cancer

Conditions: Cervical Cancer

Summary: concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. however, in patients with advanced cervical cancer, half of them treated with contemporary radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. how to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation. the major aim of this project is to conduct a prospective, randomized phase iii clinical trial to examine if cervical cancer patients treated by radiotherapy with cisplatin and gemcitabine have better survival rates than those treated by radiotherapy with cisplatin alone. gemcitabine has been demonstrated to be a good radiosensitizer. in keeping with this, few clinical trials in early phases showed promising results when using concurrent radiotherapy with cisplatin and gemcitabine. according to these positive results, the investigators expect this trial has the potential to improve the survival in patients with advanced cervical cancer, reduce the medical costs due to tumor relapse, and then benefit the whole society.

i). study end points primary end point: patient survival, including overall survival and progression-free survival. secondary end points: 1. acute toxicity during treatment 2. tumor response rates 3. sites of recurrence 4. long-term complications and quality of life ii). design of study an open-label, prospective randomized trial with two treatment arms: * arm i: patients receive ccrt with weekly cisplatin only. * arm ii: patients receive ccrt with cisplatin plus gemcitabine. iii). study population 1) number of subjects: a total of 172 patients (86 per treatment arm) will be accrued for this study within 4 years. conduct of study

Eligibility criteria:
inclusion criteria: * histologically confirmed primary squamous cell carcinoma of the uterine cervix. * previously untreated disease. * clinical figo stage iii-iva or pelvic/para-aortic lymph node positive by pet examination. * no known metastases to supraclavicular nodes or other organs outside the radiotherapy field. * ages eligible: 35 years - 70 years. * patients must have adequate bone marrow, pulmonary, liver and renal function documented before radiotherapy. wbc \> 3000/mm3, platelet \> 100,000/mm3, serum transaminases (got, gpt) \ 60 ml/min). * performance status 0 or 1 (see appendix i). * the interval between rt and randomization is not greater than 3 weeks. * patients must have signed informed consent to participate this study. exclusion criteria: * age \> 70 or \< 35 * medical or psychological condition that would preclude treatment. * previous chemotherapy or pelvic rt. * small cell carcinoma, adenocarcinoma or adenosquamous carcinoma. * patient unreliable for treatment completion and follow-up.

Keywords: cervical cancer concurrent chemoradiotherapy gemcitabine
continous positive airway pressure (cpap) compliance study

Conditions: Obstructive Sleep Apnea (OSA)

Summary: does an internet based text or email interaction and education improve cpap compliance for patients with obstructive sleep apnea (osa) and reduce nursing intervention.


Eligibility criteria:
inclusion criteria: * adults (age 18 - 90 years of age) newly diagnosed with osa who have been recommended cpap therapy. exclusion criteria: * previously attempted cpap, requires the use of bilevel positive airway pressure device, difficulty with english language such that they have difficulty understanding instructions given at high school equivalent, periodic limb movement associated arousals greater than 20/hour, primary complaint of insomnia, diagnosis of restless leg syndrome or periodic limb movement disorder
comparing the efficacy of tdcs and trns to improve reading skills in children and adolescents with dyslexia

Conditions: Developmental Dyslexia

Summary: the present study grounds on the absence of evidence-based treatment in individuals with developmental dyslexia (dd). at this topic, the present study will explore the potential effect of transcranial random noise stimulation (trns) and transcranial direct current stimulation (tdcs) over bilateral temporo-parietal cortex (tpc), cerebral areas usually disrupted in individuals with dd. the investigators hypothesized that active trns and tdcs over tpc will boost reading skills in children and adolescents with dd. on the contrary, sham (placebo) trns and tdcs over tpc will not have significant effect in improving reading skills. further, both active and sham trns and tdcs will be safe and well tolerated.

the study design is within-subject, randomized stratified, double blind, placebo-controlled. a group of children and adolescents with dd will be selected and exposed to three different conditions with an interval-session of at least 6 days: 1. trns over bilateral tpc; 2. anodal tdcs over left tpc (cathode over right tpc); 3. sham trns or tdcs. during stimulation (both real and sham), participants will undergo a concomitant reading task. in this project, the investigators will work to understand whether a brain-based intervention, with the use of trns and tdcs, can improve the outcome of individuals with dd. the protocol will allow the investigators to: * comparing the efficacy of tdcs and trns over tpc in improving reading abilities, * comparing the safety and tolerability of tdcs and trns in children and adolescents. the investigator's overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in dd, based on the two most used brain stimulation techniques in pediatric population.

Eligibility criteria:
inclusion criteria: * children and adolescents with dyslexia (dsm-5, apa 2013) * iq ≥ 85 exclusion criteria: * having a comorbidity with an important medical conditions; * having neurological diseases; * having epilepsy o family history of epilepsy; * receiving a treatment for dyslexia in the previous three months before the baseline screening.

Keywords: children adolescents trns transcranial random noise stimulation tdcs transcranial direct current stimulation neurodevelopmental disorders non-invasive brain stimulation transcranial electrical stimulation eeg reading abilities
a phase 1, randomized, controlled, observer-blinded trial to evaluate the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in healthy adults aged 18 to 49 years

Conditions: Pneumococcal Infections

Summary: this is a phase 1 first-in-human, randomized, controlled, observer-blinded study with a 2-arm parallel design. healthy adults aged 18 to 49 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (tdap) (control group).


Eligibility criteria:
inclusion criteria: 1. male or female adults 18 to 49 years of age. 2. healthy adults determined by medical history, physical examination, laboratory screening, and clinical judgment to be eligible for the study. 3. negative serum pregnancy test for all female subjects who are of childbearing potential. exclusion criteria: 1. baseline laboratory test results outside of the normal reference range considered clinically significant. 2. history of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) associated with a vaccine. 3. history of culture-proven invasive disease caused by s pneumoniae. 4. previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation. 5. vaccination with diphtheria-, pertussis-, or tetanus-containing vaccine(s) from 12 months before investigational product administration, or planned receipt through study participation. 6. male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study participation and for at least 6 months after the last dose of investigational product.