Kornimate/medical-research-clean huggingface dataset:
the effect of probiotics on constipation, and intestinal microflora in children with functional constipation

Conditions: Functional Constipation

Summary: to compare the differences of fecal microflora between constipated and non-constipated healthy children, and evaluate the efficacy of probiotics in reducing symptoms of constipation and the influence of intestinal microflora in children with functional constipation.

the investigators performed a monocentric, prospective, randomized controlled trial including 120 pediatric patients (aged 6 months - 10 years old) with functional constipation and 30 healthy age-matched healthy children as control. the investigators shall evaluate the children according to the rome iii diagnostic criteria for functional constipation. the 120 enrolled patients are randomized in to two groups: group a receiving magnesium oxide and probiotics (miyairi-bm), group b receiving only magnesium oxide. each patient is assigned the evaluation constipation symptoms and detection of microflora (beneficial and harmful bacteria) in fecal samples at the enrollment, 4 weeks, and 12 weeks. patients who take less than 80% of the appropriate dose of medications are withdrawn from the study. all patients included in the study will be given informed oral consent before entering the study. the data of the fecal microflora evaluated in 60 healthy children are used as control.

Eligibility criteria:
inclusion criteria: rome iii diagnostic criteria for functional constipation for children aged 6 months - 4 years old is as the following: 1. two or fewer defecations per week. 2. at least one episode per week of incontinence after acquiring toileting skills. 3. history of excessive stool retention. 4. history of painful or hard bowel movements. 5. presence of a large fecal mass in the rectum. 6. history of large-diameter stools that may obstruct the toilet. children aged 6 months - 4 years old is evaluated as functional constipation if two of the situations mentioned above lasted for one month. rome iii diagnostic criteria for functional constipation for children aged 4 years old and above is as the following: 1. two or fewer defecations in the toilet per week. 2. at least one episode of fecal incontinence per week. 3. history of retentive posturing or excessive volitional stool retention. 4. history of painful or hard bowel movements. 5. presence of a large fecal mass in the rectum. 6. history of large diameter stools that may obstruct the toilet. children aged 4 years old and above is evaluated as functional constipation if two of the situations mentioned above happens at least once per week exclusion criteria: 1. gastroesophageal reflux disease 2. inflammatory bowel disease 3. cardiopulmonary diseases 4. liver disease 5. renal disease 6. genetic diseases 7. endocrinal diseases 8. received abdominal surgeries
prediction of placental fetal growth restriction in high risk population (popfgr)

Conditions: Fetal Growth Retardation

Summary: this study intends to prospectively enroll high-risk pregnant women to establish a multicenter cohort. by combining maternal basic characteristics, medical history, early pregnancy ultrasound, and biological markers, we aim to construct a joint predictive model for mvm-fgr.

clinical guidelines do not recommend clinical screening for mvm-fgr in low-risk populations. predictive models for fgr are often based on preeclampsia prediction models or down syndrome serum screening models, which have limited utility. this study aims to establish a multi-center prospective cohort of pregnant women at high risk for fgr. we will collect baseline characteristics of pregnant women, ultrasound measurements of fetal growth, structural scans, maternal-fetal doppler blood flow, as well as maternal serum and plasma in first and mid-trimester. serum and plasma biomarker testing will be conducted. we will regularly observe fetal growth data, maternal-fetal complications during pregnancy, and collect delivery information, conditions of the newborn and placental pathology results after birth. by integrating maternal medical history, serum and plasma biomarkers, doppler ultrasound, and other factors, we will establish a combined predictive model for early and mid-term mvm-fgr.

Eligibility criteria:
inclusion criteria: * pregnant women with gestational age of \<14 weeks * maternal age between 18 and 45 years old * with at least one of fgr high risk factors: 1. maternal age \>40 years 2. nulliparous, maternal age \>38 years 3. previous pregnancy with fgr, pe or placental abruption 4. maternal medical history of chronic hypertension, diabetes mellitus, chronic nephritis or autoimmune diseases (such as sle or aps) 5. recurrent spontaneous abortion (rsa) \> 3 times with unknown causes * or with at least two of the following fgr high risk factors: 1. maternal age 35\~40 years 2. bmi ≥ 28 kg/m2 or bmi \< 18.5 kg/m2 3. conception with assisted reproductive technology 4. interval from previous delivery: \> 5 years or \< 6 months exclusion criteria: * presence of fetal genetic abnormalities or severe structural abnormalities in prenatal ultrasound or genetic testing.
oral enzastaurin in participants with relapsed mantle cell lymphoma

Conditions: Mantle-Cell Lymphoma

Summary: the purposes of this study are to determine the safety of oral enzastaurin and any side effects that might be associated with it and whether enzastaurin can help participants with mantle cell lymphoma.


Eligibility criteria:
inclusion criteria: * mantle cell lymphoma * previous treatment for mantle cell lymphoma * previously relapsed mantle cell lymphoma with no more than 4 chemotherapy regimens. * have discontinued all previous therapies for cancer, except corticosteroids up to 25 milligrams per day (mg/day) * adequate organ function exclusion criteria: * inability to swallow tablets * must not have significant heart problems
identifying optimal peep after lung transplantation

Conditions: Lung Transplant; Complications; Primary Graft Dysfunction

Summary: lung transplantation (lutx) is the curative treatment for selected patients with end-stage lung disease. primary graft dysfunction (pgd), a specific form of respiratory failure occurring within the first 72 hours after graft reperfusion, represents the most common complication after lutx. actual recommendation regarding management of mechanical ventilation of the lung graft immediately after lutx are based only on opinion experts and not on clinical trials. optimization of positive end-expiratory pressure might contribute to both prevention and treatment of pgd. in this interventional single-center non-pharmacological study (with medical device), in the immediate postoperative period of patients who are undergone lutx, we will evaluate the effects of varying levels of peep upon: - lung and chest wall mechanics, - intrapulmonary shunt fraction; - distribution of ventilation and perfusion; - gas exchange. the final aim is to find the optimal level of peep in this patient's cohort


Eligibility criteria:
inclusion criteria: * recipient of lutx * age \> 18 years * signed informed consent exclusion criteria: * age \< 18 years * already undergone lutx * major hemodynamic instability along the 24 hours following lutx: systolic arterial pressure \ 120 beat/min and/or high dose vasopressor requirement (norepinephrine \> 0.3 mcg/kg/min and/or epinephrine \> 0.2 mcg/kg/min and/or dobutamine \> 8mcg/kg/min) * documented post-lutx endobronchial plasma leak requiring high levels of peep \> 15 cmh2o

Keywords: lung transplantation primary graft dysfunction mechanical ventilation positive end-expiratory pressure electrical impedance tomography
safety and efficacy of intracoronary adult human mesenchymal stem cells after acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: early reperfusion strategies in tandem with remarkable advances in drugs and devices for treating myocardial infarction (mi) have contributed to a reduction in early mortality, but cardiovascular disease remains the leading cause of death worldwide. current management strategies cannot solve the problem of cardiomyocyte loss and consequent progression of heart failure. in this respect, stem-cell therapy has shown potential benefits for repairing the damaged myocardium. mesenchymal stem cells (mscs) have been considered to be attractive therapeutic candidates because of their high capacity for replication: paracrine effect: ability to preserve potency: and because they do not cause adverse reactions to allogeneic versus autologous transplants. intracoronary injection of stem cells seems to be safe, but only one clinical trial using mscs via the intracoronary route in the setting of acute myocardial infarction (ami) has been carried out. the investigators therefore assessed the safety and efficacy of intracoronary autologous bone marrow (bm)-derived human mscs in patients with ami.


Eligibility criteria:
inclusion criteria: * aged 18-70 years * ischemic chest pain for \>30 min * admitted to hospital \<24 h after the onset of chest pain * electrocardiography showed st segment elevation \>1 mm in two consecutive leads in the limb leads or \>2 mm in the precordial leads * they could be enrolled in the study \<72 h after successful revascularization exclusion criteria: * cardiogenic shock (defined as systolic blood pressure \<90 mmhg requiring intravenous pressors or intra-aortic balloon counterpulsation) * life-threatening arrhythmia * impossible conditions for cardiac catheterization * advanced renal or hepatic dysfunction * history of previous coronary artery bypass graft * history of hematologic disease * history of malignancy * major bleeding requiring blood transfusion * stroke or transient ischemic attack in the previous 6 months * structural abnormalities of the central nervous system (brain tumor, aneurysm, history of surgery) * traumatic injury after myocardial infarction * use of corticosteroids or antibiotics during the previous month * major surgical procedure in the previous 3 months * cardiopulmonary resuscitation for \>10 min within the previous 2 weeks * positive skin test for penicillin * positive result for viral markers (human immunodeficiency virus (hiv), hepatitis b virus (hbv), hepatitis c virus (hcv) and venereal disease research laboratory (vdrl) test) * pregnancy, possible candidate for pregnancy or breastfeeding females * drug abusers * inappropriate patients to participate in the study according to the chief investigator

Keywords: mesenchymal stem cells myocardial infarction left ventricular dysfunction
multicenter performance study of quadquik invitro diagnostic device

Conditions: HIV Infections; Hepatitis C; Hepatitis B; Syphilis Infection

Summary: to demonstrate clinical performance of the triquik invitro diagnostic device

measurement methodology whole blood samples are collected by fingerstick. samples tested immediately. using the supplied sample dropper, transfer specimen blood drop into the two sample wells. wait 20-30 seconds. add two drops of the supplied assay buffer (\~90µl) to the same sample wells read result in 20 mins. primary end points will determine how accurate these tests are (p\<=0.02) by analyzing for: diagnostic sensitivity; tp / (tp + fn) the ability of the test to correctly identify those patients with the disease diagnostic specificity; tn / (tn + fp) the ability of the test to correctly identify those patients who are truly free of the specific disease positive predictive value: tp / (tp+ fp) the probability that subjects with a positive test truly have the disease. negative predictive value: tn / (fn + tn) the probability that subjects with a negative test truly don't have the disease. an estimated 200 patients are to be enrolled as follows: 150 with a documented medical history of hiv, hbv, hcv or syphilis. a combination of 2 or 3 conditions is acceptable. hbsag patients need to have a hbsag on file \< 2 years. hiv and hcv or syphilis patients only need one antibody test in their medical chart. 50 with no documented medical history of hiv, hbv, hcv or syphilis and are considered normal. male or female subjects, ages ≥18 years.

Eligibility criteria:
inclusion criteria: a documented medical history of hiv, hbv, hcv or syphilis. a combination of 2 or 3 conditions is acceptable. hbsag patients need to have a hbsag on file \< 2 years. hiv and hcv patients only need one antibody test in their medical chart. no documented medical history of hiv, hbv, hcv or syphilis and are considered normal. male or female subjects, ages ≥18 years. signed informed consent provided by an authorized subject representative (based on local institutional review board (irb)/ethics panel requirements).- exclusion criteria: any other condition or prior therapy, which, in the opinion of the investigator, would make the subject unsuitable for this study. participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days before randomization.-
a study evaluating the efficacy and safety of tislelizumab versus chemotherapy in advanced non-squamous non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this study evaluated the efficacy and safety of tislelizumab in combination with platinum (cisplatin or carboplatin) and pemetrexed compared with platinum and pemetrexed alone as first-line treatment in participants with stage iiib or iv non-squamous non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: 1. age 18-75 years old, male or female, signed informed consent form 2. advanced nsclc diagnosed by pathological or clinical physicians 3. eastern cooperative oncology group (ecog) performance score ≤ 1 4. participants must have ≥ 1 measurable lesion as defined per recist v1.1 5. participants must have no prior systemic chemotherapy for advanced or metastatic nsclc 6. life expectancy ≥ 12 weeks 7. participants must have adequate organ function 8. male/female is willing to use a highly effective method of birth control exclusion criteria: 1. diagnosed with nsclc but with epidermal growth factor receptor (egfr)-sensitizing mutation or anaplastic lymphoma kinase (alk) gene translocation 2. received any approved systemic anticancer therapy within 28 days prior to the initiation of study treatment 3. received prior treatment with egfr inhibitors or alk inhibitors 4. received prior therapies targeting programmed cell death protein-1 (pd-1) or programmed cell death protein ligand-1 (pd-l1) 5. with history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases 6. clinically significant pericardial effusion 7. severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis 8. any major surgical procedure ≤ 28 days before randomization 9. human immunodeficiency virus (hiv) infection 10. participants with untreated hepatitis b or c virus (hbv/hcv) 11. active autoimmune diseases or history of autoimmune diseases 12. history of allergic reactions to chemotherapy note: other protocol defined inclusion/exclusion criteria may apply.
multiple ascending doses of amg 139 in healthy and crohn's disease subjects

Conditions: Crohn's Disease

Summary: the purpose of this study is to assess the safety and tolerability of amg 139 following multiple intravenous (iv) or subcutaneous (sc) dose administration in healthy subjects and in subjects with mild to severe crohn's disease (cd).


Eligibility criteria:
inclusion criteria: part a - healthy subjects: * healthy male or female of non-reproductive potential subjects between 18 to 45 years-of-age * body mass index (bmi) between 18 and 32 kg/m2 * normal or clinically acceptable physical examination, clinical laboratory values, and ecg * additional inclusion criteria apply part b - crohn's subjects: * male or female subjects with cd between 18 to 55 years-of-age * body mass index (bmi) between 18 and 32 kg/m2 * normal or clinically acceptable physical examination (pe), clinical laboratory values, and ecg; clinically acceptable pe includes evidence of mild to severe cd * diagnosis of ileal or ileo-colonic cd for a minimum of 6 months * mild to severe cd defined by a crohn's disease activity index (cdai) score equal to or greater than 180 and equal to or less than 450 * elevated fecal calprotectin and crp * additional inclusion criteria apply exclusion criteria: parts a - healthy subjects: * history or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion; * recent or on-going infection(s) * underlying condition(s) that predisposes the subject to infections * history of malignancy of any type * additional exclusion criteria apply part b only - crohn's subjects: * history or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion; * recent or on-going infection(s) * underlying condition(s) that predisposes the subject to infections * history of malignancy of any type * additional exclusion criteria apply

Keywords: amgen amg 139 crohn's disease
observational study for assessing treatment and outcome of patients with primary brain tumours using cimpact-now and 2021 who classification

Conditions: Glioma; Glioneuronal Tumor; Choroid Plexus Tumor; Pineal Tumors; Germ Cell Tumor; Tumor of the Sellar Region; Diffuse Midline Glioma, H3 K27M-Mutant; Ependymoma; Embryonal Tumor; Pineal Tumor; Hemangiopericytoma; Hemangioblastoma; Melanocytic Tumor of CNS

Summary: every new classification depends on its prognostic power and on the type of treatment given. with the rapid evolution of diagnostic methods and the advance in new treatments, there is much less reliable information available on how patients with newly defined brain tumour entities should be treated and what to expect from the current treatments. the goal is to determine whether the new 2021 who classification, based on cimpact-now recommendations, results in more homogeneous patient groups than the old 2016 classification. furthermore, it will help derive provisional guidelines on how patients with these newly defined tumour entities are best treated. these recommendations will be based on the experience of eortc investigators with chosen treatments and their experience as reported in this data collection report.


Eligibility criteria:
inclusion criteria: * newly diagnosed or recurrent primary brain tumours, notably those considered rare brain tumours or rare subtypes of common brain tumours. * archival tumour tissue from primary tumour available at the site. representative tissue from first surgery is preferred, but tissue from surgery for recurrence is allowed. * before patient registration, written informed consent must be given according to ich/gcp, and national/local regulations. * inclusion in interventional studies prior and after

Keywords: rare primary brain tumor 2021 who classification molecular diagnosis gliomas choroid plexus tumors embryonal tumors pineal tumors
hdv screening study

Conditions: Hepatitis D Virus Infection

Summary: this is a territory-wide cross-sectional study of all individuals living with hiv/hbv coinfection and hbv-related hcc.

chronic hepatitis b virus (hbv) infection remains endemic in hong kong with an estimated prevalence of 6.2% in the recent population health survey 2020-2022.1 the estimated prevalence of chronic hbv infection among individuals living with hiv is 8%.2 yet, no data are available concerning the disease burden of hepatitis delta virus (hdv) among individuals living with hiv/hbv coinfection.

Eligibility criteria:
inclusion criteria: 1. individuals with hiv infection, i.e. anti-hiv or hiv rna positive; and 2. individuals with chronic hepatitis b, i.e. hepatitis b surface antigen (hbsag) or hbv dna positive for two times at least 6 months apart; and 3. aged 18 years old or above. 4. written or verbal consent obtained exclusion criteria: 1. refusal to consent 2. age \< 18 years

Keywords: hdv
fruquintinib in patients with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer (mCRC)

Summary: fruquent is an observational study in germany. the goal of the study is to evaluate how well fruquintinib works to treat patients with metastatic colorectal cancer that have previously been treated with available standard therapies. to this end, it will be analyzed how well patients respond to the therapy in the clinical routine. further points of interest to the study are survival data, safety data, the use of medical care facilities, and the quality of life of patients treated with fruquintinib. participants will be treated as decided by the treating physician and according to their routine practice.

fruquent is a prospective, multicenter, observational study in germany, collecting real-world data of patients with metastatic colorectal cancer (mcrc) who receive fruquintinib according to the smpc. the goal of the study is to analyze the effectiveness of the monotherapy with fruquintinib in adult patients with mcrc that have previously been treated with available standard therapies, including fluoropyrimidine, oxaliplatin-, and irintecan-based chemotherapies, anti-vegf agents, and, if ras wild-type, anti-egfr agents. moreover, the patients must have progressed on or be intolerant to treatment with either trifluridine/tipiracil or regorafenib. all data for fruquent will be obtained in routine clinical practice, allowing for a representative evaluation of the effectiveness of fruquintinib in a real-world setting. the study aims to recruit 150 patients in 50 practices (office based, oncology outpatient-centers or hospitals) to facilitate robust data.

Eligibility criteria:
inclusion criteria: * aged 18 years or older. * indication and decision for therapy with fruquintinib in accordance with the current german smpc of fruquintinib as monotherapy for patients with mcrc. * prior treatment with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan based chemotherapies, anti vegf therapy, and if ras wild-type, anti egfr therapy. * progression on or intolerance to treatment with either trifluridine/tipiracil and/or regorafenib. * other criteria according to current smpc. * signed written informed consent.\* \* patients are allowed to be enrolled up to 6 weeks after their first dose of fruquintinib. these patients cannot participate in the pro assessments. exclusion criteria: * participation in an interventional clinical trial (except follow-up) within 30 days prior to enrollment or start of treatment with fruquintinib, whatever comes first. * contraindications according to current smpc.

Keywords: non-interventional fruzaqla electronic qol questionnaire real-world disease control rate later line fruquintinib
body-oriented therapy for sexual abuse recovery

Conditions: Child Abuse, Sexual; Post-Traumatic Stress Disorder; Dissociation

Summary: the purpose of this study is to examine and compare the effects of two body therapy approaches in women who have experienced child sexual abuse.

women who have experienced child sexual abuse often display symptoms of dissociation and lack of bodily self-awareness which hinder the recovery process. mind-body researchers have examined alternative therapeutic approaches to eliminating these factors. this study will compare a standardized therapeutic message to body-oriented therapy which involves a combination of hands-on bodywork and verbal therapy focused on somatic and emotional awareness.

Eligibility criteria:
inclusion criteria: * self-reported child sexual abuse * in current psychotherapy for child sexual abuse recovery exclusion criteria: * over 6 months of past experience with body-oriented therapy * diagnosis or medications for psychosis * drug or alcohol addiction * current abusive relationship * dissociative disorder * in transition on psychotropic medication

Keywords: mental health psychotherapy