Kornimate/medical-research-clean huggingface dataset:
a trial of linaclotide 290 μg in patients with irritable bowel syndrome with constipation (ibs-c)

Conditions: Irritable Bowel Syndrome Characterized by Constipation

Summary: to evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 μg administered orally to patients with ibs-c.

this study consists of a 12-week treatment period followed by 4-week randomized withdrawal (rw) period.

Eligibility criteria:
inclusion criteria: * patient has no clinically significant findings on a physical examination and clinical laboratory tests * female patients of childbearing potential must agree to use one of the following methods of birth control: 1. hormonal contraception 2. double-barrier birth control 3. maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy * patient meets protocol criteria for diagnosis of ibs-c * patient demonstrates continued ibs-c symptoms through pretreatment period * patient maintains a minimum level of compliance with daily diary exclusion criteria: * patient has history of loose or watery stools * patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain * patient has a structural abnormality of the gastrointestinal (gi) tract or a disease or condition that can affect gi motility * patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
rapid and safe sputum suction method validation

Conditions: Sputum

Summary: 600 comatose patients admitted to the hospital in china from june 2024 to june 2028 were randomly divided into groups a and b. group a used intermittent negative pressure suction through oral and pharyngeal ventilation, while group b used continuous negative pressure suction through regular oral and nasal suction.

research content: (1) selection and placement methods of oropharyngeal ventilation tubes, studying the application effects of different models and sizes of oropharyngeal ventilation tubes in critically ill patients, exploring the best placement method to improve the efficiency and safety of sputum suction operations. (2) the norms and techniques of sputum suction, the steps, techniques, and precautions of sputum suction, the depth, strength, time of insertion, and when to interrupt negative pressure, in order to minimize damage to the patient's respiratory mucosa. (3) evaluation of patient comfort and tolerance, assessing the tolerance and potential adverse reactions of critically ill patients during oral pharyngeal intubation for sputum suction, providing a basis for optimizing sputum suction. (4) evaluation of sputum suction effect, comparing blood oxygen saturation, respiratory distress, sputum sounds, and other indicators before and after sputum suction to evaluate the effectiveness of sputum suction.

Eligibility criteria:
inclusion criteria: * 1. clinical diagnosis of stroke; 2. clinical diagnosis of comatose; exclusion criteria: * 1. clinical diagnosis of multiple organ failure; 2. clinical diagnosis of multiple organ bleeding;
individualized precise localization of rtms on precentral and parietal gyrus

Conditions: Attention Deficit Hyperactivity Disorder

Summary: attention deficit hyperactivity disorder (adhd) patients have some problem with sustained attention. the dorsal anterior cingulate cortex (dacc) plays a key role for attention control. it has been found that the dacc has strong functional connectivity with ipsilateral motor area and parietal gyrus. repetitive transcranial magnetic stimulation (rtms) is a sage and painless technique to activate cortical areas. the deep brain structure can be activated via stimulating superficial cortex by rtms. for investigating the mechanism of sustained attention, this project is using functional magnetic resonance imaging (fmri) to individualize the precise localization in motor area and parietal gyrus, and combining rtms to activate the dacc.

healthy subject is recruiting in this project. high rtms will be performed. the 10-hz stimulation is delivered at 100% of the subject's resting motor threshold via 60 trains of 3-s 10-hz rtms (30 pulses with 27-s duration per train).

Eligibility criteria:
inclusion criteria: * there are activation in dacc, motor area and parietal gyrus during the task fmri * the head motion less than 2 mm in translation or 2 degrees in rotation in any direction during the resting-state fmri exclusion criteria: * without any neuropsychiatric conditions * no head injury or history of epilepsy * not on any medications

Keywords: fmri rtms functional connectivity
efficacy and safety assessment for a new uv-protected pump infusion line in intravenous infusion therapy

Conditions: Subarachnoid Hemorrhage

Summary: to verify the efficacy and safety of original perfusor line (art.no.8723017) in infusion therapy in patients with light sensitive drug infusion. subjects who choose to use original perfusor line for their planned infusion treatment (nimodipine injection) as per the study protocol will be enrolled. the 300 subjects will be 1:1 randomized into the experimental group or the control group, using original perfusor line (art.no. 8723017) connected with an injection pump for infusion treatment with nimodipine injection or original perfusor line (art.no.8723010) connected with an injection pump for infusion treatment with nimodipine injection, respectively.use of both the test product and the control product will be in strict accordance with their package insert. the primary endpoint is the percentage of products which successful infuse fluids or medications into patient's circulatory system without leakage of fluids or medications, visible catheter embolism, air embolism and micro embolism in the infusion system and the secondary endpoint is the quality assessment for the clinical application of the products,such as the percentage of products which are qualified for infusion administration including link and removal, transparence, and tenacity.


Eligibility criteria:
inclusion criteria: * aged ≥18 years, all genders; * patients who will be treated plan to use injection pump for infusion treatment with nimodipine injection by infusion pump. * participated in this study voluntarily and signed informed consent form. exclusion criteria: * patients have contraindication on nimodipine. * patients allergic to polyethylene (pe) material; * patients with aspartate transaminase(ast) and alanine transaminase(alt) are 2 times higher than normal range, serum creatinine(scr) is 1.5 times higher than normal range. * patient with malignant tumor, pregnant or lactation; * patients had participated in other clinical trials within 1 month and in parallel with other trials; * patients are unsuitable to participate in this study as judged by the investigator.

Keywords: pump infusion photodegradation iv infusion therapy
optimizing resilience and coping in hiv via internet delivery

Conditions: HIV Disease; Depression; Affect; Psychological Stress

Summary: this is a feasibility/pilot test of a set of positive affect skills provided online to hiv positive people with elevated depressive symptoms - a center for epidemiological studies depression scale d (ces-d) score \> 10. the investigators will test the feasibility of recruitment, retention and acceptability of these skills in an online delivery format, determine feasibility and acceptability of daily emotion assessments via text messaging and assess efficacy of these skills for improving psychological well-being this population.


Eligibility criteria:
inclusion criteria: * hiv + * 18 or older * score of ces-d depression scale \>10 * daily internet access * smart phone ownership exclusion criteria: -
diaphragmatic breathing during virtual reality exposure therapy for aviophobia

Conditions: Fear of Flying

Summary: the study investigated the effect of diaphragmatic breathing as an additional coping strategy during virtual reality exposure therapy in patients with aviophobia. the authors assumed that diaphragmatic breathing (db) would lead to less fear and physiological arousal during the vret and to an enhanced treatment outcome

patients with aviophobia received treatment in virtual reality with or without db. the authors assumed that adding db to vret would enhance treatment effects by reducing fear during exposure, thus improving the processing of the feared situation. the authors hypothesized that, as a result, self-efficacy would be increased in comparison to vret alone.

Eligibility criteria:
inclusion criteria: * age 20 to 65 * flying experience * subjective rating of fear of flying \> 60 from 100 exclusion criteria: * pregnancy * heart disease * current involvement in psychotherapy and/or pharmacotherapy

Keywords: diaphragmatic breathing virtual reality exposure therapy
use of nerv's inline device as an early diagnostic method for postoperative complications

Conditions: Anastomotic Leak

Summary: nerv's traditional feasibility clinical trial is a multi-center, pre-market, single-arm, and non-randomized trial. this study will involve the retrospective analysis of prospectively collected data. the trial is intended to establish the safety of nerv's inline device and collect preliminary data to illustrate the change in ph and electrical conductivity during normal postoperative recovery and in the event of a complication. the purpose of nerv's feasibility study is to establish a clinical model that shows the progressive change in ph and electrical conductivity during a normal post-operative recovery and in the event of an anastomotic leak in colorectal, hepatobiliary (hpb), trauma, and general surgery patients. upon analyzing data collected from nerv's inline device, a clinical model of change in ph and conductivity over time will be created. the clinical model can be used in future stages to determine if a complication is developing. for instance, boundaries (reading thresholds) can be established to detect a complication when readings exceed such boundaries.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years - male or female * subject understands and has voluntarily signed and dated informed consent form (icf) * subjects must be willing to comply with trial requirements * subject has a peritoneal drain, such as jackson pratt drain attached post abdominal surgery exclusion criteria: * plans that the subject will be discharged in less than 8 hours post-surgery * involvement in the planning and conduct of the clinical investigation * subject is participating in another investigational drug or device study which may interfere with the endpoints of this study * nerv's inline device does not attach to drain used on the subject
b'more for a peaceful motherhood hypertension control study

Conditions: Hypertension

Summary: this study will assess whether an intervention including mindfulness, dietary education, and smoking cessation can help african-american women of childbearing age (age 18-44) with hypertension or high blood pressure to lower their blood pressure. the investigators propose to screen women of childbearing age for hypertension, and to invite women to participate in an intervention to reduce their blood pressure. the investigators will track their perceived stress and their blood pressure levels over the next 6 months. half of the women who participate will be given a blood pressure cuff and taught to measure their own blood pressure. more frequent tracking of blood pressure will be done in these women.

chronic and pregnancy-associated hypertension increase risk for poor birth outcomes, including higher rates of low birthweight and preterm birth. mindfulness interventions, dietary education, and smoking cessation education have all been effectively employed to reduce hypertension, but have infrequently targeted women of childbearing age in community settings. this study will screen african-american women of childbearing age for hypertension, and invite women with hypertension to participate in a seven-session intervention to reduce blood pressure. the investigators will track their perceived stress and their blood pressure levels over the next 6 months. half of the women who participate will be given a blood pressure cuff and taught to measure their own blood pressure. more frequent tracking of blood pressure will be done in these women.

Eligibility criteria:
inclusion criteria: * hypertension * age 18-44 * african-american * female exclusion criteria: * male * age \ 44 * non-african american * not female * pregnant
study comparing the efficacy of venlafaxine xr vs. ssris and conventional antidepressants in depressed patients

Conditions: Major Depressive Disorder

Summary: this study is an open-label, randomized, multi-center study conducted in a typical psychiatric outpatient practice in china. this study is intended to collect data on the efficacy and safety of venlafaxine xr (efexor xr®) versus ssris and conventional antidepressants in depressed patients that previously failed antidepressant treatment. this data will be used to guide psychiatrists on recommendations for clinic use.


Eligibility criteria:
main inclusion criteria: * males or females, 18 -65 years of age * outpatients * major depressive disorder based on dsm-iv criteria * the baseline score of 17-item ham-d³17 * switchers from prior antidepressants, who have had no satisfactory improvement (normally after a minimum of 8weeks of treatment), with an approved antidepressant medication or have experienced intolerance due to side effects to their antidepressant medication based on clinical discretion * provide written informed consent * if female is of childbearing potential, must be confirmed no pregnancy at baseline, and use a medically acceptable method of contraception throughout the study. main exclusion criteria: * hypersensitivity to venlafaxine; * clinically significant renal or hepatic disease or any other medical disease that, in the opinion of the investigator, might compromise the study, including seizure * alcohol or drug abuse within the last year * a recent history of myocardial infarction or unstable heart disease (within 6 months of baseline) * bipolar disorder * for female, known or suspected pregnancy or breast feeding * use of a monoamine oxidase inhibitor (maoi) within 14 days of baseline; use of any investigational drug within 30 days of baseline. * patients have prior use of venlafaxine or use of venlafaxine for the current episode.
pulmonary function in non-hospitalized adults and children after mild covid-19

Conditions: SARS-CoV-2 Infection

Summary: the study investigates whether patients with mild sars-cov-2 infection, who stayed at home during their infection and weren't hospitalized, have any persisting sequelae in pulmonary function. therefore, 110 patients, aged 6-60 years, were recruited by telephone 4-12 weeks after laboratory-confirmed positive pcr and invited for a lung function testing. every patient with abnormalities in pulmonary function was invited to a follow-up 3 months after the first appointment to assess changes in lung function values. patients with a pre-existing lung disease and smokers within the last five years were excluded beforehand. additionally to lung function testing we did a throat swab at each appointment to analyse via multiplex pcr whether the patients had any other respiratory infection at the time of the pulmonary function testing.

110 patients, 90 adults and 20 children, were recruited. the lung function included lci, fev1, fvc and dlco (hb corrected). additionally we did a throat swab at each appointment to analyse via multiplex pcr whether the patients had any other respiratory infection at the time of the test.

Eligibility criteria:
inclusion criteria: * sars-cov-2 infection, non-hospitalized during infection exclusion criteria: * smoking, existing lung disease (copd, asthma bronchiale)

Keywords: mild covid-19 lci lung function non-hospitalized covid-19
sleep spindles and memory in rolandic epilepsy

Conditions: Rolandic Epilepsy; Rolandic Epilepsy, Benign; Centrotemporal Epilepsy; Centrotemporal; EEG Spikes, Epilepsy of Childhood; Epilepsy; Seizure; Epilepsy

Summary: the investigators are recruiting children with rolandic epilepsy and children without epilepsy (aged 4 years old and above) for a non-invasive brain imaging study using magnetic resonance imaging (mri), magnetoencephalography/electroencephalography (meg/eeg), and experimental tasks. the investigators hope to determine the brain circuits and brain rhythms affected in these children and ultimately identify new treatment options for childhood epilepsy patients.

this is a prospective study of epilepsy biomarkers in a total of 100 subjects of ages 4-18. participants will spend about 5 hours at the massachusetts general hospital (mgh) athinoula a. martinos center for biomedical imaging. they will undergo training on a memory task concurrent with eeg/meg recordings. during the eeg, subjects will wear headphones that will deliver a quiet pink noise stimulus intermittently during a nap. the auditory stimulus will be calibrated in volume to not cause arousals. after napping, subjects will undergo cognitive testing and memory task testing.

Eligibility criteria:
inclusion criteria: 1. ages 4-18 years 2. diagnosed with childhood epilepsy with centrotemporal spikes (cects) or rolandic epilepsy by child neurologist 3. has eeg with sleep activated centrotemporal spikes 4. has had at least 1 focal motor or generalized seizure exclusion criteria: 1. has abnormal brain mri 2. has other unrelated neurological disease 3. unable to have an mri/meg 1. claustrophobic 2. history of frequent vomiting 3. permanent metal in body, braces 4. over mri weight limit: 350lbs
a controlled breathing intervention to reduce stress and improve symptoms in copd patients (rest)

Conditions: COPD; Stress; Dyspnea

Summary: this is a parallel design, randomized, controlled pilot trial comparing a controlled breath intervention (rest) to usual care for reducing stress in individuals with copd.

this is a parallel design, randomized, controlled pilot trial comparing a controlled breath intervention (rest) to usual care for reducing stress in individuals with chronic obstructive pulmonary disease (copd). the intervention is based on the breathing techniques of pranayama. it was developed with patient and stakeholder input and is targeted for individuals with copd who have moderate levels of stress and symptom burden. the intervention is a 15-minute breathing protocol which will be taught to participants and subsequently evaluated in a clinic setting with surveys, lung function, and cardiac assessments. this intervention will be pre-tested in 6 individuals, revised, and piloted in 30 individuals (15 in intervention group, 15 in control group). this study will answer the question of 1) whether a controlled breath protocol is feasible, acceptable, and safe for patients with copd and 2) whether any modifications to the intervention are needed for a future multicenter trial to be proposed and conducted after the completion of the pilot trial. we will also 3) obtain sufficient estimates of variability in stress measures to inform statistical planning of a future trial.

Eligibility criteria:
inclusion criteria: * diagnosis of spirometry confirmed copd (fev1/fvc \<0.70 + fev1\<80%) * perceived stress scale \> 13 * age \>40 years old * able to read, write, and speak in english * able to attend 1 in person training session and 1 in person trial sessions exclusion criteria: * current regular practice of breathing exercises or pranayama * no access to internet or telephone * recent hospitalization for copd exacerbation or any reason in the past 30 days * other primary lung disease (ild, asthma, bronchiectasis) by self-report or chart review * non-correctable hearing impairment (i.e. hearing impairment despite hearing aids) * severe cognitive impairment
eculizumab for prevention and treatment of kidney graft reperfusion injury

Conditions: End-Stage Renal Disease; Kidney Failure; Graft Reperfusion Injury

Summary: study of eculizumab ability to correct the reperfusion injury of the kidney allograft.

based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion injury, it is hypothesized that c5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. it was further hypothesized that eculizumab, antibody that blocks c5 cleavage in humans will be an effective prophylactic agent to prevent ischemic reperfusion injury in high risk recipients. for testing this hypothesis, this study is a pilot prospective study to test the efficacy of eculizumab in preventing the development of reperfusion injury and contribute graft survival.

Eligibility criteria:
inclusion criteria: 1. age 1-80 2. weight - \>6 kg 3. male or female 4. recipient of first kidney graft either from standard criteria deceased or live donor 5. end stage renal disease or congenital nephrotic syndrome - exclusion criteria: 1. blood group (abo) incompatible transplantation 2. presence of donor-specific anti-human leukocyte antigen (hla) antibodies 3. multiorgan transplantation 4. previous transplant 5. patients infected with hiv, hepatitis c virus (hcv) or hepatitis b virus (hbv) 6. patients with haemolytic-uraemic syndrome (hus) -

Keywords: eculizumab kidney transplantation reperfusion rejection infection
high-dose imatinib for relapsed/refractory c-kit positive acute myelogenous leukemia (aml)

Conditions: AML

Summary: this is a multicenter open-label phase ii trial of high dose imatinib mesylate in patients with aml in first or second relapse, or with refractory disease. daily dosing of imatinib 600 mg/day is planned for one month or until progression of disease. dose increase to 800 mg/ day imatinib is permitted for 2 additional months in the event of response failure. response is assessed after 1, 2 and 3 months of treatment by bone marrow aspirate.

daily dosing of imatinib 600 mg/day is planned for one month or until progression of disease. dose increase to 800 mg/ day imatinib is permitted for 2 additional months in the event of response failure. novartis provided supplies of imatinib for all patients included in the study.

Eligibility criteria:
inclusion criteria: * age \> 18 years, * aml in first or second relapse, * refractory aml * performance status of 0-2 on the eastern cooperative oncology group scale, * adequate hepatic and renal functions (ast or alt \<= 5 times the upper limit of normal * creatinine \< 2 times the upper limit of normal) * 20% blasts in bone marrow, * 70% of bone marrow blast population c-kit positive as assessed by immunophenotyping * bcr-abl negative chromosomal analysis (assessed by fluorescence in situ hybridization; fish), and no chromosome 5-12 translocation exclusion criteria: * previous treatment by imatinib * secondary aml