Kornimate/medical-research-clean huggingface dataset:
preventive effect of perinatal oral probiotic supplementation (pops) on neonatal jaundice

Conditions: Neonatal Jaundice; Microtia; Pregnancy Related; Hyperbilirubinemia, Neonatal

Summary: this is a randomized double-blind placebo-controlled parallel group superiority clinical trial among 94 pregnant women (47 in each group) to investigate the effect of maternal perinatal probiotic supplementation on neonatal jaundice, breast milk microbiome, maternal stool, and infant fecal microbiome. vivomixx®-probiotic product will be used as treatment and placebo as a control.

neonatal jaundice is a yellowish discoloration of the skin and sclera because of over-concentration of circulating unconjugated bilirubin (hyperbilirubinemia) in the body. it can lead the baby to severe complications including death. intestinal flora modulation by probiotics administration to the mother may tackle this problem. therefore, investigators designed a randomized double-blind placebo-controlled parallel group superiority clinical trial among 94 pregnant women (47 in each group). eligible pregnant women will be recruited voluntarily at 28-36 weeks of gestation and allocated randomly to either the probiotic group (vivomixx®) or placebo group (maltose-containing unit) which are phenotypically similar. participants will take one sachet of the product per day starting from 36 weeks of gestation until the end of first week of postpartum. biological samples (maternal stool, breast milk, and neonatal faeces) will be collected at different time points. additionally, neonatal transcutaneous bilirubin will be measured on the second and seventh day of life using a drager meter (a transcutaneous bilirubinometer). the microbial dna will be extracted from biological samples using commercial kits and metagenomics sequencing will be employed and will be correlated with bilirubin level using appropriate statistical methods. this study will be conducted based on the helsinki declaration and international council for harmonization requirements for pharmaceuticals for human use (ich) guideline for good clinical practice (gcp) standards. ethical approval is obtained from the joint chinese university of hong kong and new territories east cluster (cuhk-ntec) clinical research ethics committee, hong kong with reference number: 2023.100-t. written informed consent will be obtained from each participant during enrolment.

Eligibility criteria:
inclusion criteria: * all pregnant women aged 18-45 years old. * gestational age of 28-34 weeks * normal singleton pregnancy exclusion criteria: * foetal abnormality * mothers with antibiotic medication during the allocation * couples with glucose 6-phosphate dehydrogenase enzyme deficiency * couples with known rhesus or haemolytic disease history * plan of place of birth at other hospitals other than prince of wales hospital * known breast disorder or any contraindication for breastfeeding.
phase ii efficacy study looking at a single-dose of one of three dose levels of ain457 in patients with chronic plaque-type psoriasis

Conditions: Chronic Plaque Psoriasis

Summary: this is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses of ain457 to placebo. subjects with a diagnosis of moderate to severe chronic plaque psoriasis will be randomized to receive either ain457 at one of the three doses studied or placebo.


Eligibility criteria:
inclusion criteria: * diagnosis of plaque psoriasis for at least 6 months prior to screening. the patients must meet all of the following criterion: 1. coverage of the body surface area (bsa) of 10% or more with plaques 2. a score of 3 or more on the iga (investigator global assessment) scale 3. a pasi score of at least 12 at baseline; exclusion criteria: * have forms of psoriasis other than the required "plaque psoriasis" * women of childbearing potential * recent use of investigational drugs or treatment with other biological therapies (wash-out periods required) * previous treatment with this investigational drug * subjects with active or history of clinically significant cardiac, kidney or liver abnormalities other protocol-defined inclusion/exclusion criteria may have applied.

Keywords: plaque psoriasis, skin condition, thickening, flaking, skin disease, autoimmune disease
cocoa, polyphenols, and the kidney in healthy subjects and in subjects with hypertension and diabetes mellitus

Conditions: Diabetes

Summary: observing how cocoa effects the cardiovascular and renal system.

study designed to assess the vascular benefits of drinking cocoa that is rich in polyphenols. vascular beds studied will include kidney, brain, eye, and periphery (finger). time course of the effects will be studied in healthy normal (including elderly), and also in subjects with type i and type ii diabetes. renal blood flow will be determined by pah/in u test clearance. cranial ultrasound will be used to measure brain blood flow. retinal blood flow will be assessed by specialized ultrasound/doppler device. peripheral blood flow is measured by plethysmography. urine and blood samples will be assayed for routine physiologic parameters, including hormone assessment, and also for the presence of cocoa metabolites.

Eligibility criteria:
inclusion criteria: diabetes (type i and ii), with or without hypertension, blood pressure \<165/105 exclusion criteria: under 18 or over 85 years old, women who are pregnant or able to become pregnant, history of heart attack, stroke or chest pain within the past 6 months, kidney disease, heart disease, severe high blood pressure not controlled by medication

Keywords: cocoa, diabetes, polyphenols
focus guidelines and adherence to physical activity in ageing women.

Conditions: Frail Elderly Syndrome; Mood; Quality of Life; Cognitive Decline; Social Interaction; Adherence, Patient

Summary: the study aimed at assessing whether the guidelines from the european project focus had an effect on adherence to a physical activity program in older women. the program consisted of two 12-week periods, in which women followed a set of pre-specified exercises (1 hour, twice per week). the first period was supervised by a monitor while the second was autonomous. support groups, in which the contact between participants was established through information and communication technologies (social-network through the mobile phone), were set up to maintain engagement between participants. women were randomized to three arms consisting of 2 intervention groups, with and without the focus guidelines, and a sedentary control. secondary outcomes included a battery of dimensions affecting physical performance, psychological status, and quality of life.

the objectives of the study consisted of assessing i) whether the use of the guidelines derived from the european project focus had an effect on the adherence to a physical activity (pa) program (primary objective), and ii) the effect of the program, which included 2 h/week of pa, on a group of dimensions related with general health, frailty, psycho-cognitive parameters, and quality of life (qol) (secondary objectives). the study comprised 24 weeks in which a group of 90 postmenopausal women were randomised to three arms, two in which participants were performing pa, and one control (no intervention). the first pa group followed the focus guidelines, in which women received monthly health talks and had an internet mailbox to facilitate contact with health professionals. the pa program consisted of a twice per week 1-hour session along 24 weeks. this period was divided into two parts, a first supervised phase in which women followed group sessions under direct supervision of a monitor, and a second period in which the groups of women followed the same exercise pattern, but autonomously. a mobile phone support system (social network whatsapp) was used for inter-connection and mutual support during the autonomous period. assessments were performed at baseline and then at 12 weeks and 24 weeks, representing the completion of the supervised and the autonomous periods, respectively.

Eligibility criteria:
inclusion criteria: community living postmenopausal women capable of performing the physical activity program and with ability to sign the informed consent. exclusion criteria: physical or psychological deficiencies incapacitating subjects to participate in the established physical program.

Keywords: physical activity adherence frailty mood socialisation quality of life cognition
neurofeedback training for pd

Conditions: Parkinson Disease; Healthy

Summary: the goal of this clinical trial is to test neurofeedback training in both people with parkinson's disease and healthy control. the main questions it aims to answer are: * to demonstrate that eeg based or stn lfp based neurofeedback can help patients with parkinson's disease to volitionally modulate pathological brain activities measured non-invasively; * to evaluate the learning effect of the neurofeedback training with multiple training sessions patient participants will be asked to receive the research intervention called neurofeedback training for maximal three separate sessions. during the intervention, the participants will also be asked to press a pinch meter as fast as possible in order to measure the reaction time, meanwhile, different type of brain signals will be recorded. . this will be a within-subject cross-over study contrasting the effect of the neurofeedback training and no training.


Eligibility criteria:
inclusion criteria: * participants with symptomatic parkinson's disease or age-matched healthy control * adequate understanding of verbal explanation or written information given in english * able and willing to give informed consent. * normal or corrected-to-normal vision exclusion criteria: * lack of capacity to consent (judged by the researcher taking consent as not having sufficient mental capacity to understand the study and its requirements)
comparison of qt interval readings between smartwatch combined with cardiologs artificial intelligence and 12-lead ecg

Conditions: Atrial Fibrillation

Summary: the watchqt study will compare the performance of a smartwatch combined with cardiologs ecg ai analysis system in monitoring corrected qt (qtc) intervals with that measured on a manually read 12-lead ecg in subjects with normal sinus rhythm (nsr) during antiarrhythmic drug (aad) initiation and follow-up at the hospital.

the watchqt study is a prospective, non-significant risk, non-randomized, monocentric, open, comparative, concordance pilot study. under subject consent, subjects hospitalized for aad initiation and monitoring will have smartwatch ecg recordings done simultaneously with 12-lead ecg measurements before and after drug administration twice a day, in accordance with the existing in-stay subject monitoring protocol.

Eligibility criteria:
inclusion criteria: 1. subjects over 22, able and willing to participate in the study 2. subjects who are admitted to the hospital in nsr or af and are eligible for aad (class ia or class iii) dose initiation or re-initiation. 3. subjects having read the patient information letter and provided his/her consent to participate in writing, by dating and signing the informed consent prior to any trial-related procedure being conducted exclusion criteria: 1. subjects with cardiac implantable electronic devices (cied) 2. pregnant or breast-feeding subjects
efficacy study of raloxifene to induce ovulation in polycystic ovarian syndrome

Conditions: Polycystic Ovarian Syndrome

Summary: this study examines raloxifene versus clomiphene to induce ovulation in women with polycystic ovarian syndrome (pcos).

clomiphene citrate (cc) is the major pharmaceutical treatment of anovulation in polycystic ovary syndrome, used for over 40 years. despite the vast experience using this drug, the pregnancy rates associated with its use are low and recent large studies from australia regarding birth defects suggest that cc may be associated with birth defects. alternatives to cc are limited. another selective estrogen receptor modulator, raloxifene (ral) does not have the long half life exhibited by cc, and has recently been shown to be equivalent to cc in terms of ability to induce ovulation in pcos women. in addition, prior studies have demonstrated potential benefits on markers of uterine receptivity in a cell line model by blocking estrogen activity. beyond this, there are no studies to examine whether raloxifene is an effective oral agent for the treatment of women desiring pregnancy, but the investigators' hypothesis is that raloxifene will work as well as cc but be better at establishment and maintenance of pregnancy than cc

Eligibility criteria:
inclusion criteria: 1. women aged 18 to 36 2. bmi \> 19 \& \< 40 3. pcos diagnosis as evidenced by: oligo- and/or anovulation (\< 6 cycles per year) and one of the following: * clinical and/or biochemical signs of hyperandrogenism * polycystic ovaries and exclusion of other aetiologies (congenital adrenal hyperplasias, androgen-secreting tumors, cushing's syndrome) exclusion criteria: 1. use of ovulation induction agents within the past 6 months 2. positive pregnancy test before taking study medications 3. history or current thromboembolic disorder 4. coronary artery disease such as heart attack or stroke 5. tobacco use or history within the past 6 months 6. history of pelvic inflammatory disease and tubal factor infertility 7. congenital adrenal hyperplasia 8. diabetes mellitus * any subject on metformin must "wash out" for 30 days prior to screening 9. history of endometriosis 10. known male factor infertility

Keywords: pcos infertility anovulation
mobile apps for the treatment of depression

Conditions: Major Depressive Disorder

Summary: smartphone applications (apps) may be well-suited as a low cost adjunctive tool for increasing the adherence of individuals to psychotherapy treatments which may subsequently increase symptom reduction and improve clinical outcomes. apps offer the opportunity for real-time tracking of behavior and have the ability to provide prompt feedback and reminders in a convenient, readily available technology. the immediacy and convenience of apps may be responsible for the observed improvements in adherence on the part of the patients relative to traditional paper-and-pencil tracking and practice of skills taught in psychotherapy. these features are relevant to behavioral activation (ba) protocols, the effects of which are often attenuated by failure to adhere to regular practice and tracking of behavior. the mood coach app is a ba protocol developed to provide a convenient means of planning and tracking activity, and monitoring mood responses to scheduled increases in activity. this project evaluates the utility of this app as an adjunct to standard ba treatment. the investigators predict that participants assigned to the ba+app condition will demonstrate greater adherence to the ba treatment compared to the standard ba condition. the investigators also predict that the participants in the ba+app condition will report greater satisfaction with the app compared to the standard ba protocol that utilizes paper and pencil materials.


Eligibility criteria:
inclusion criteria: * veterans aged 18 and older * speak and understand english * meet criteria for major depressive disorder * willing to participate in psychotherapy for depression exclusion criteria: * current psychotic disorder diagnosis * current bipolar disorder * diagnosed with a substance use disorder that is not currently being addressed by a non-study provider * patients receiving a concurrent evidence-based psychotherapy for depression or ptsd

Keywords: depression technology psychotherapy behavioral activation
clinical evaluation of nano hydroxyapatite reinforced glass ionomer in treatment of root caries in geriatric patients

Conditions: Dental Restoration Failure

Summary: in geriatric patients, will the clinical performance of nano hydroxyapatite reinforced glass ionomer be better than conventional glass ionomer cement in treatment of root caries lesions over one year follow up?

glass carbomers are commercialized under the name of gcp glass fill, this material may be an interesting subject of research, certainly its bioactive properties as the manufacturer claims this material to have remineralizing properties. if this is the case, gcp glass fill could be an interesting reference material for further bioactivity studies

Eligibility criteria:
inclusion criteria: * • ≥ 50 years old * males or females. * community-dwelling * have five or more of their own teeth * with ≥ 1 root caries lesion exclusion criteria: * • patients younger than 50 years old * disabilities. * systemic diseases or severe medically compromised.

Keywords: glass carbomer gcp glass fill root caries clinical perfomance
neuroendocrine regulation of bone-fat crosstalk in obesity

Conditions: Obesity; Endocrine; Pituitary Dysfunction; Bone Health

Summary: to study the effect of neuroendocrine dysfunctions on bone health in obesity

it is a multicentric, observational, cross-sectional non-profit study with additional procedures. the study will include obese patients (bmi\>30) with and without hyper functioning pituitary adenomas (acromegaly, cushing and prolactinoma) and hypopituitarism (gh deficiency, secondary hypogonadism) aimed at studying the effect of metabolic phenotypes of obesity and neuroendocrine dysfunctions on bone health. patients enrollment will take place in ospedale san raffaele, azienda ospedaliera universitaria federico ii di napoli and uoc endocrinologia-aou renato dulbecco, università degli studi di catanzaro magna graecia.

Eligibility criteria:
inclusion criteria for subjects with pituitary disease: * male and female subject \> 18-year-old (also fertile patients can be included) * patients with prolactinoma or cushing disease, acromegaly or hypogonadism/hypopituitarism * bmi ≥30 kg/m2 * able to sign an informed consent inclusion criteria for subjects without pituitary disease * male and female subject \> 18-year-old * bmi ≥ 30 kg/m2 * able to sign an informed consent exclusion criteria: * male and female subject \<18-year-old * pregnant or breastfeeding women * subject unable to sign informed consent * bmi \< 30 kg/m2
single anastomosis sleeve jejunal bypass as a revisional bariatric procedure

Conditions: Obesity, Morbid

Summary: single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band

in this study the investigators aim to test the efficacy of single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band

Eligibility criteria:
inclusion criteria: obese patients with bmi more than 40 with or without co-morbidity or more than 35 with co-morbidity * patients fit for laparoscopic surgery * give approval to share in the study * previous restrictive bariatric procedure exclusion criteria: * patients unfit for surgery * patients aged less than 18 and older than 60 * patient with previous upper abdominal surgery either for obesity or other diseases
effectiveness of oscillation on postoperative pulmonary complications after elective postcardiac surgery

Conditions: Postoperative Pulmonary Atelectasis

Summary: our study aims to evaluate the effectiveness of continuous high-frequency oscillation therapy in reducing ppcs in patients following elective cardiac surgery. through a prospective, multicenter, randomized controlled trial, we seek to establish evidence that could lead to improved postoperative pulmonary care and outcomes for cardiac surgery patients.


Eligibility criteria:
inclusion criteria: * adult patients (18 years or older) undergoing elective cardiac surgery will be included. participants must provide informed consent upon icu admission and have at least one risk factor for ppcs, including age ≥ 75 years, american society of anesthesiologists (asa) score ≥ 2, history of chronic obstructive pulmonary disease (copd) stage ≥ 2 or asthma (moderate to severe), current heavy smoking or heavy smoking history within the past 6 months, obstructive sleep apnea, frailty index \> 0.21 or body max index (bmi) ≥ 30 kg/m². exclusion criteria: * patients will be excluded if they have contraindications for oscillation treatment (e.g., untreated tension pneumothorax); have pneumothorax or air leak syndrome at entry; require more than 2 μg/kg/min of norepinephrine; have been diagnosed with pneumonia within 2 weeks prior to surgery; have refractory arrhythmia at entry; have a left ventricular ejection fraction \ 35 mmhg; are postoperative from spinal surgery within the past 2 weeks; require a ventricular assist device; have renal failure requiring continuous renal replacement therapy (crrt) at entry; are planned for re-operation within 48 hours or have undergone organ transplantation.

Keywords: postcardiac surgery oscillation postoperative pulmonary complications
selection and efficacy-influencing factors of first-line biologic agents in moderate-to-severe ulcerative colitis

Conditions: Ulcerative Colitis (UC)

Summary: the purpose of this prospective, multicenter, real-world study is to compare the efficacy differences and influencing factors of different first-line biologics in patients with moderate to severe ulcerative colitis. the question that this study aims to answer is: when treating patients with moderate to severe ulcerative colitis, should ifx or vdz be prioritized as the first-line choice for biologics?, which biological agent has better therapeutic effect?. researchers will observe and follow up with patients with moderate to severe ulcerative colitis treated with different biologics on the front line, evaluate their condition changes, eliminate relevant interfering factors, and draw the final conclusion.


Eligibility criteria:
inclusion criteria: * age range of 18-70 years old, gender not limited; * according to international guidelines and consensus, patients with ulcerative colitis should be diagnosed to exclude radiation enteritis, infectious enteritis, tumor related diseases, etc; * patients assessed as moderate to severe ulcerative colitis based on the mayo score; * during the follow-up period, no relevant treatments (drugs and surgery) were used that could affect the assessment of the efficacy of biologics exclusion criteria: * patients with hemodynamic instability; * patients with obvious liver and kidney function injury: bilirubin, aminotransferase (alt, ast) exceeded the upper limit of normal by 2 times; egfr\<60ml/min or dialysis patients; * patients allergic to ifx or vdz; * patients whose primary disease was gastrointestinal malignancy; * patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.; * female patients during pregnancy and breastfeeding (including patients with reproductive needs); * patients with current infection with infectious diseases (hepatitis b, hepatitis c, syphilis, aids, tuberculosis, etc.); * patients who cannot cooperate with regular follow-up and review of laboratory indicators; * any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.

Keywords: biologics ulcerative colitis