Kornimate/medical-research-clean huggingface dataset:
effect of prebiotic fructans to reduce number of febrile infections in children

Conditions: Infectious Disease; Children, Only; Diet Modification

Summary: the study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on the reduction of the number of febrile infections diagnosed by the paediatrician in children.


Eligibility criteria:
inclusion criteria: * subject is healthy at the time of pre-examination * subject is aged 3-6 years at the time of pre-examination * subject attends a kindergarten at the time of pre-examination exclusion criteria: * suffering from current infection or has suffered from infection in previous 7 days * intake of antibiotics and/or laxatives in the previous 14 days prior to start of the intervention * children with known gastrointestinal disease or malformation * children with congenital or acquired immunodeficiency * children with food intolerance, food allergy * children that regularly consume (more than 3 times per week) probiotic products or a food supplement containing prebiotics * children involved in any clinical or food study within the preceding 6 months
change of neural network indicators through narrative treatment of ptsd in torture victims

Conditions: PTSD

Summary: effective treatment of ptsd involves talking about the traumatic event in detail.it is unclear how this process influences the sensory-specific trauma network (fear structure)in the traumatized person. the goal of the project is to test the hypothesis that treatment-facilitated recovery does not change the original fear structure but establishes an inhibitory mechanism that depends on verbal activity. an affective visual steady-state paradigm in magnetencephalography (meg) using positive, aversive and neutral picture stimuli will be used to examine the spatial and temporal pattern of the processing of emotional stimuli. to examine the effects of treatment this paradigm will be used as outcome measure within a randomized controlled trial of narrative exposure therapy and a waiting-list control condition for severely traumatized torture victims.


Eligibility criteria:
inclusion criteria: * experiences of organized violence/torture * ptsd diagnosis exclusion criteria: * psychotic disorder * neurological disease or seizures * current drug/alcohol abuse

Keywords: ptsd torture survivors narrative exposure therapy trauma-related memory processes steady state visual evoked fields
the efficacy evaluation of choleswise pressed candy on cardiovascular health

Conditions: Cardiovascular Diseases

Summary: to assess the efficacy evaluation of choleswise pressed candy on cardiovascular disease risk factors

this is a single center, randomized, double-blind and placebo controlled study. subjects are informed to consume the samples every day for 8 weeks.

Eligibility criteria:
inclusion criteria: * age ≥ 30 years old, no gender limit; * patients with high blood pressure (systolic blood pressure\> 120 mmhg or diastolic blood pressure\> 80 mmhg) or high blood lipids (tc ≥ 5.18 mmol/l or tg ≥ 1.7 mmol/l), and no medication is used; * fully understand the purpose, benefits, potential risks and side effects of this research, and can objectively cooperate with doctors to complete the examination and assessment of diseases and physical conditions; * people who voluntarily agree and sign an informed consent form. exclusion criteria: * people with a history of dyspepsia would affect the absorption of the test product; * any situation that may affect trial process, including difficult-to-control organic disease or infection, unstable angina pectoris, congestive heart failure and other severe disease; * people with symptomatic and difficult-to-control neurological, mental diseases or mental disorders; * pregnant or breast-feeding women or women who have a positive result on a pregnancy test; * allergic to the components of the test product; * take supplementary foods and health supplements with the same efficacy two weeks before and during the test.
early apical release vs classic holmium laser enucleation of the prostate: randomized controlled trial comparing post-operative incontinence rates and surgical outcomes

Conditions: Benign Prostatic Hyperplasia

Summary: to determine if early apical release holmium enucleation of the prostate (ear holep), as a surgical treatment for benign prostatic hyperplasia, reduces post-operative urinary incontinence compared to classic holep.


Eligibility criteria:
inclusion criteria: * patients must be 18 years of age or older * patients must present to clinic with a diagnosis of benign prostatic hyperplasia * patients must be scheduled to undergo a holmium laser enucleation of the prostate exclusion criteria: * patients with previous surgical management of bph * patients with prostate biopsy revealing high risk prostate cancer * patients with a concomitant neurogenic bladder diagnosis (sci, parkinson, ms, cerebral palsy)
trial of integrated smoking cessation, exercise and weight management in serious mental illness: triumph

Conditions: Mental Illness

Summary: this study will determine whether an 18-month practical tobacco smoking cessation program integrating weight management counseling and exercise will be superior to treatment as usual in achieving prolonged smoking abstinence in persons with serious mental illness.

the objective of this study is to perform a randomized clinical trial (triumph) in persons with serious mental illness to test the hypothesis that intervention participants will have higher rates of smoking abstinence at 18 months than participants in the treatment as usual arm. the intervention includes group and individual smoking cessation and weight management counseling tailored by a participant's readiness to quit, pharmacotherapy with either varenicline or buproprion plus nicotine replacement therapy prescribed in the community clinic, exercise, and text messaging supporting health behavior change.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or recurrent major depression meeting criteria for serious mental illness * fagerstrom test for nicotine dependence of ≥3 and daily cigarette smoking for at least the past 6 months (on days that cigarettes were available) * on stable psychotropic medication for mental illness for at least 30 days (i.e., antipsychotic medication for those with schizophrenia spectrum illness, mood stabilizer for those with bipolar disorder) * competent and willing to give informed consent * completion of baseline data collection * willing to participate in smoking cessation intervention that includes combination of evidence-based behavioral (group and individual sessions) and pharmacotherapeutic smoking cessation aids exclusion criteria: * serious cardiovascular event (e.g. myocardial infarction, stroke) within the past 6 months * serious unstable medical condition that limits life expectancy * pregnant, breastfeeding, or planning a pregnancy during study period. * alcohol or illicit substance use disorder if not sober/abstinent for ≥ 30 days * planning to leave mental health program or move out of geographic area within 18 months review by treating psychiatrist required for those with inpatient psychiatric hospitalization within six months of enrollment.

Keywords: weight management physical activity tobacco smoking serious mental illness
fk506 phase 3 study: a study for steroid non-resistant myasthenia gravis (mg) patients

Conditions: Myasthenia Gravis

Summary: the purpose of the study is to investigate the efficacy and safety for steroid non-resistant mg patients in a double blind, placebo controlled study.


Eligibility criteria:
inclusion criteria: * clinically diagnosed as myasthenia gravis * those whose mg symptoms are well-controlled by the treatment with prednisone * steroid non-refractory myasthenia gravis: ≧20mg and ≦40mg / alternate day of steroid dose required to maintain exclusion criteria: * those who have thymoma or the history of thymoma (masaoka stage iii or iv) * patients who received steroid pulse therapy, plasma exchange therapy, globulin therapy or radiation therapy within 12 weeks prior to the initiation of test drug * patients who started the immunosuppressant therapy or increased the dose of immunosuppressant within 12 weeks prior to the initiation of test drug. * patients who had undergone thymectomy within 24 weeks prior to the initiation of test drug. * pancreatitis or diabetes * serum creatinine≦1.5mg/dl

Keywords: tacrolimus myasthenia gravis
low bacterial diet in patients with cytopenia

Conditions: Cytopenia

Summary: the purpose of this prospective, randomized study was to determine the efficacy of low bacterial diet, in comparison to normal hospital diet, with gut colonization by aerobic gram negative rods and yeasts as primary endpoint. in addition, the occurrence of infections and the total costs of hospital care were documented, in order to identify potential cost savings by the use of either diet.

patients with hematological malignancies who receive intensive chemotherapy usually develop a period of cytopenia, during which there is an increased risk of infection. mucositis can also develop in these patients, enabling micro-organisms, belonging to the endogenous intestinal flora, to translocate from the intestine to the lymphoid tissue and blood. therefore, when mucositis and cytopenia develop simultaneously, the risk of infection increases further. in this regard bloodstream infection by gram negative rods and yeasts are an important cause of serious infections causing considerable morbidity. in order to reduce the risk of infection several preventive measures have been adopted. fundamentally, all of these measures were designed to prevent either acquisition of gram negative rods or fungal pathogens from the environment, or the translocation of these potential pathogens across the mucosal barrier of the gut. these measures include protective (or reverse) isolation, antibiotic prophylaxis with antibiotics which selectively eradicate the aerobic gram negative rods and yeasts from the gut flora, and finally the use of low-bacterial diets. in this prospective, randomized study on the efficacy of low bacterial diet, in comparison to normal hospital diet, gut colonization by aerobic gram negative rods and yeasts, the occurrence of infections and the total costs of hospital care were chosen as study endpoints.

Eligibility criteria:
inclusion criteria: * acute leukemia receiving remission induction chemotherapy * receiving antibiotic prophylaxis for cytopenia leukocytes lower than 1000/mm3 in peripheral blood) * informed consent exclusion criteria: * none

Keywords: chemotherapy diet hematological malignancy infection prevention protective isolation patients with cytopenia due to intensive chemotherapy for hematological malignancy
the effectiveness of dexketoprofen on shoulder pain using different physiotherapy treatments

Conditions: Shoulder Pain

Summary: the purpose of this study is to determine whether dexketoprofen administered by phonophoresis or iontophoresis is more effective in the treatment of subacromial syndrome that the conventional therapy with ultrasounds.

it is a question of valuing the decrease of the pain (by means of the visual analogic scale pain score) and the increase of the functionality of the joint (by means of dash and constant scores) of three different treatments from physical therapy to establish the most effective protocol for the treatment of the subacromial syndrome. determine the best physiotherapy treatment for subacromial syndrome with 20 sessions of different treatments. a group will receive the conventional treatment with ultrasounds without drugs, another group will receive dexketoprofen by phonophoresis and the third group will receive dexketoprofen by iontophoresis.

Eligibility criteria:
inclusion criteria: * subacromial syndrome diagnosed by ultrasound scanning with rotator cuff tendinitis or partial break of the rotator cuff and / or of the brachial biceps. * informed consent. exclusion criteria: * to suffer shoulder arthritis or any shoulder pathology with mobility limitation. * fibromyalgia * psychologic or psychiatric pathologies * hypersensibility to the drug * back or shoulder traumatism * to have received an analgesic infiltration on the affected shoulder in the last month * lack of adherence to the treatment upper to 15 % of the sessions

Keywords: subacromial syndrome dexketoprofen phonophoresis iontophoresis ultrasounds vas dash score constant score
feasibility of process-based therapy in a naturalistic setting

Conditions: Depressive Disorder; Anxiety Disorder

Summary: the main objective is to explore the feasibility of process-based therapy in a natural mental health care setting delivered by practitioners.

in the naturalistic setting of mental health care, treatment decisions of psychotherapists are often based on theories or experience related to treatment approaches. an alternative approach to treatment decision is suggested by process-based therapy (pbt), which emphasizes empirical and rational criteria for the selection of intervention. it utilizes ecological momentary assessment (ema) data, incorporates feedback from dynamic network analysis, and supports interventions based on individual network models and empirical evidence from research related to change processes. currently, there are no data on the feasibility and acceptability of pbt in practice. the present study investigates in a naturalistic setting, whether pbt can be implemented by psychotherapists in mental health care. furthermore, the investigators explore the acceptability and efficacy of pbt as compared to psychotherapy delivered in routine practice (r-pt).

Eligibility criteria:
inclusion criteria: * a primary dsm-5 diagnosis of a depressive or anxiety disorder * age 18-65 years * sufficient knowledge of the german language * participating patients are not required to discontinue medication, but to keep medication constant over the treatment period exclusion criteria: * increased suicidality * substance abuse or dependency * diagnose of a cluster a or b (dsm-5) personality disorder * pervasive developmental disorder * psychotic disorder * eating disorder * bipolar disorder * severe physical illness

Keywords: feasibility process-based therapy
descriptive evaluation of expulsive efforts during pregnancy in term nulliparous women by measurement of intra bladder pressure: pilot observational study.

Conditions: Perineal Tear

Summary: severe complications of childbirth are common. many factors have been studied to assess their imputability in the occurrence of perineal tears. while women subjectively have different push profiles in terms of intensity, frequency and duration of each push effort, no study has evaluated this variability in a relevant, simple and reproducible way. through this work, it is expected to establish a qualitative evaluation of the expulsive efforts during childbirth in term nulliparous women by measuring the intra bladder pressure which testifies of the pressure exerted on the perineal tissues due to maternal pushing efforts

scientific context: it is clearly observed in clinical practice that there seems to be significant variability in the characteristics of the expulsive phase from one woman to another without this being clearly described to date. during the same expulsive phase, the number, intensity and duration of each push can be very different from one woman to another. considering that during expulsive efforts, the fetal head exerts pressure on the perineal tissues , the repetition of these compressions, moreover if they are prolonged or brought closer together could generate muscular lesions by hyper extension of the fibers, by microtrauma or by tissue hypoxia. these variations in the characteristics of expulsive efforts could thus modify the perineal risk for women. more than the expulsive efforts evaluated by the recording of intra uterine pressures which has already been described, it is the evaluation of the mechanical stresses transmitted to the perineum secondary to the pushing efforts that we would like to record by the installation of a sensor pressure connected to the woman's bladder catheter. investigations during the second phase of labor, at 8 cm dilation, after information and obtaining free and informed consent, women will be included by one of the md investigators. 3 visits are planned in the protocol: the first visit will be at childbirth evaluation of the mechanical stresses transmitted to the perineum secondary to the pushing efforts by the installation of a sensor pressure connected to the woman's bladder catheter follow up a prospective study including nulliparous term pregnant women with 2 other visits planned at 3 months (12 to 16 weeks) and 6 months (26 to 30 weeks) after delivery, to assess secondary perineal complications

Eligibility criteria:
* inclusion criteria : * pregnant women aged of 18 years or more * 37 weeks or more of pregnancy * without any previous delivery (vaginal or cesarean delivery) * with a cephalic presentation fetus * with epidural analgesia at 8 cm cervical dilatation (inclusion) * - exclusion criteria: * pathological pregnancy (intrauterine growth restriction, pre-eclampsia etc.) * untreated psychiatric disorders * women under judicial protection * women without health insurance
study of global coagulation tests in patients with paroxysmal nocturnal haemoglobinuria

Conditions: Paroxysmal Nocturnal Haemoglobinuria

Summary: paroxysmal nocturnal haemaoglobinuria (pnh) is a rare disease which results in breakdown of the red blood cells and bone marrow failure. it is associated with an increased risk of blood clots. until recently, treatment has been with blood transfusions and in patients with a blood clot, blood thinners. a new treatment called eculizumab is now standard for patients who require regular blood transfusions. it works in the majority of patients by preventing the breakdown of red blood cells. this can eliminate the need for blood transfusion and reduce the risk of blood clots. it is not well understood why patients with pnh are at high risk of blood clots. the investigators plan to use specialised blood tests to assess the stickiness of the blood before starting eculizumab treatment and monthly after starting treatment. the investigators will compare these tests with standard tests of clotting.


Eligibility criteria:
inclusion criteria: * presence of a pnh clone exclusion criteria: * longterm anticoagulation for previous venous thrombosis
brca 1/2 mutation in korean patients with epithelial ovarian cancer

Conditions: To Investigate the Prevalence of BRCA 1/2 Mutation Among Ovarian Cancer

Summary: purpose: to investigate the prevalence and clinical correlation of the germline brca 1/2 mutation in korean patients with high grade(hg) serous and/or endometrioid epithelial ovarian cancer (eoc). patients and methods: in a nationwide case-control study on eoc conducted in korea between 2010 and 2015, 298 korean women with hg serous and/or endometrioid eoc were tested for gbrca 1/2 mutation, regardless of the family history. mutation screening was performed using the ion ampliseq brca 1/2 panel (life technologies, carlsbad, ca, usa) and ion pgm platform according to the manufacturer's instructions. clinical characteristics including survival outcome was assessed in gbrcam carriers.


Eligibility criteria:
inclusion criteria: * women 18 years of age and older with previously untreated, hg serous and/or endometrioid eoc, fallopian tube or primary peritoneal carcinoma who consented to genetic testing between 2010 and 2015 exclusion criteria: * women with mucinous , clear cell, low-grade serous or endometrioid, mixed epithelial adenocarcinoma, undiffereniated carcinoma or malignant brenner's tumor
the effect of inulin in irritable bowel syndrome

Conditions: Bowel Symptoms; Depression Disorders; Inulin; Constipation; Quality of Life (QOL); Irritable Bowel Syndrome (IBS)

Summary: purpose: this study was conducted to evaluate the effect of inulin on bowel symptoms, depression and quality of life in individuals with constipation-dominant irritable bowel syndrome. individuals (n=34) aged 21-63 years with constipation-dominant ibs were included in the study. individuals were divided into two groups as prebiotic group \[(n=17) (inulin/oligofructose 50/50 mixture of 4.6 g (inulin=total 9.2 g) inulin/oligofructose 50/50 mixture twice a day)\], and placebo \[(n=17), (maltodextrin=9.2 g)\] group. the intervention period was 8 weeks and bristol stool scale, ibs-visual analogue scale, ibs-symptom severity score scale (ibs-sss), ibs-quality of life scale (ibs-qol) and beck depression scale were administered to the participants at the beginning, 1st month and 2nd month. spss software programme was used for statistical analysis of the data. it is thought that inulin supplementation may be effective in reducing symptom severity and frequency, improving bowel function (stool frequency, consistency and transit time) and quality of life, and thus may be beneficial in individuals with constipation-predominant ibs.

in the treatment of ibs, a multimodel perspective that includes psychological support (cognitive behavioural therapy, stress management techniques, etc.) in addition to lifestyle changes (dietary changes, etc.) may be beneficial.

Eligibility criteria:
inclusion criteria: * the individuals were between 19-65 years of age * volunteer to participate in the study * individuals diagnosed with ibs by a physician according to rome iv criteria exclusion criteria: * a history of gastrointestinal surgery (except appendectomy and cholecystectomy) * inflammatory bowel disease * lactose malabsorption * gastroenteritis * celiac disease * gastric * duodenal ulcer * metabolic diseases (cardiac, hepatic and renal diseases, diabetes, etc.) * history of malignancy * pregnancy and lactation * use of intestinal motility * antidepressant drugs * involuntary body weight loss of more than 5 kg in the last 3 months * use of dietary fibre supplements in the last 3 months * use of antibiotics in the last 3 months * use of prebiotic and probiotic supplements in the last 3 months.

Keywords: bowel symptoms depression inulin constipation-predominant ibs quality of life
a phase 2/3 study in adult and pediatric participants with scd

Conditions: Sickle Cell Disease

Summary: the purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.

this is a three-part, multicenter, phase 2/3 study of orally administered osivelotor in participants with sickle cell disease (scd). part a will evaluate the safety, tolerability, and efficacy of osivelotor in adult participants with scd to determine an optimal dose. part b will evaluate the efficacy of osivelotor versus placebo in adult and adolescent participants with scd for 48 weeks. part c will evaluate the pharmacokinetics (pk) and safety of single and multiple doses (md) of open-label single arm osivelotor administered to pediatric participants.

Eligibility criteria:
inclusion criteria: part a, part b, and part c: * male or female with scd * participants with stable hb value as judged by the investigator * for participants taking hydroxyurea and/or l-glutamine, the dose must be stable for at least 90 days prior to signing the icf or assent and with no anticipated need for dose adjustments during the study in the opinion of the investigator. part b: * participants with scd ages 12 to 65 years, inclusive * participants with more than or equal to 2 and ≤ 10 vocs within 12 months of screening. exclusion criteria: part a, part b, and part c: * participants who had more than 10 voc within 12 months of screening * female participant who is breastfeeding or pregnant * participants who receive rbc transfusion therapy regularly or received an rbc transfusion ---for any reason within 90 days of day 1 * participants hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the icf