Kornimate/medical-research-clean huggingface dataset:
lactobacillus reuteri dsm 17938 versus placebo in the treatment of infantile colic

Conditions: Colic

Summary: infantile colic is a common medical condition which remains a frustrating problem for parents and health care providers with no clear treatment guidelines. to fill the void in existing literature, we present a protocol to examine whether probiotics are effective in decreasing infantile colic symptoms when compared to placebo treatment. we hypothesize that oral administration of the probiotic l. reuteri dsm 17938 will reduce symptoms of infantile colic in breastfed infants in comparison to placebo. an interim analysis will be conducted after 50 infants randomized to monitor both safety and efficacy.

infantile colic is one of the most commonly reported medical problems within the first three months of life causing appreciable distress for both parents and pediatricians. the reported incidence of infantile colic ranges from 3% to 28% in prospective studies and up to 40% in retrospective surveys. the pathogenesis of infantile colic remains elusive despite decades of research. it appears that multiple independent origins might be involved: amongst them infant's difficult temperament, inadequate mother-infant communication or maternal anxiety, transient lactase deficiency, exposure to cow's milk, abnormal gastrointestinal function, maternal smoking during pregnancy or after delivery. consequently, various treatment approaches have been tried to alleviate this condition. recent studies have suggested that changes of intestinal microflora of a newborn may play an important role in pathogenesis of infantile colic. therefore, dietary supplementation with probiotics has been proposed for the improvement of this condition.

Eligibility criteria:
inclusion criteria: 1. healthy term infant 21-90 days of age 2. birth weight ≥2500 g 3. exclusively breastfed (to reduce variability in the intestinal microflora attributable to dietary variations) 4. with colic symptoms (\>3 hours of crying on \>3 days per week) with debut 10 ± 5 days before enrollment 5. gestational age between 37 and 42 weeks 6. apgar score higher than 7 at 5 minutes 7. written informed consent from a parent exclusion criteria: 1. any chronic illness or gastrointestinal disorder as judged by the pediatrician 2. any history of antibiotic treatment or probiotic supplementation 3. failure to obtain a written consent by parent/legal guardian 4. participation in other clinical trials 5. infants with acute illness 6. subjects with allergies or family history of allergies to any of the ingredients of the study product or placebo

Keywords: pediatric infantile colic probiotic treatment
informed decision making intervention in screening for prostate cancer of predominantly african american participants in a community outreach program

Conditions: Prostate Carcinoma

Summary: this clinical trial studies an informed decision making intervention of screening for prostate cancer in predominantly african american participants. it also evaluates participants' knowledge about prostate cancer screening and to improve understanding. using decision aids such as culturally sensitive written material, verbal information, and videos to educate patients about screening may increase patient participation and knowledge. this may increase confidence in participants' decisions. raising awareness about prostate cancer in the communities may increase the participants' willingness to be screened for prostate cancer once they have learned about it.

primary objectives: (a) to assess the effectiveness of a proposed educational model for informed decision about prostate cancer in high risk men over age 40 which compares informed decision making and shared decision making (b) to improve knowledge about prostate cancer in men over age 18 outline: participants complete an educational intervention comprising a 10-20 minute powerpoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. some participants then undergo a screening exam comprising a prostate specific antigen level and digital rectal exam. after completion of study, participants are followed up periodically.

Eligibility criteria:
inclusion criteria: * men over the age of 18 will be asked to participate in the educational component of the program; men over the age of 40 will be offered the screening component after the educational portion of the event; participants over age of 40 will have the opportunity to make an informed decision in regards to prostate cancer screening based on this information and the educational material; american cancer society (acs) guidelines recommend having a discussion about screening in men who have an expected mortality of greater than 10 years; data on comorbidities and 10-year mortalities will be collected on every participant using the university of california at san francisco (ucsf) mortality index * educational component: men over the age of 18 * screening component: men over age 40 exclusion criteria: * known personal history of prostate cancer * active malignancy, metastatic disease, or anyone undergoing treatment for malignancy

Keywords: informed decision making prostate cancer
postspinal headache and near infrared spectroscopy (nirs)

Conditions: Tissue Oxygenation

Summary: evaluation of the relationship between postspinal headache and near infrared spectroscopy in cesarean section patients

patients with cesarean section under spinal anesthesia were included in the study. before the study, patients were moniterized with nirs device in the preoperative waiting room.nirs moniterization was continued intraoperatively at 1st, 4th, 7th, 10th, 15th, 30th minutes and 24th postoperative period. patients were divided into two groups as those with postspinal headache (group a) and those with postspinal headache (group b). in this study, nirs values between two groups were compared.

Eligibility criteria:
inclusion criteria: * elective cesarean section exclusion criteria: * not willing to participate in the study * use of anti-psychotic or anti-depressant drugs * patients with headaches

Keywords: cesarean section post spinal headache near infrared spectroscopy
efficacy and tolerability of ily101 in dialysis patients with hyperphosphatemia

Conditions: Kidney Diseases; Renal Insufficiency

Summary: this is a randomized, dose-ranging, efficacy and tolerability study in chronic kidney disease patients with hyperphosphatemia on hemodialysis. patient participation in the study is approximately 10 weeks in duration.

hyperphosphatemia is associated with abnormally high blood concentrations of phosphorus. normally, phosphorus in the body is excreted into urine via the kidneys, but this process is impaired when renal function is reduced. hyperphosphatemia occurs in many patients with renal insufficiency, especially those on dialysis. high blood phosphorus concentrations trigger various complications caused by phosphorous interaction with blood calcium or parathyroid hormones, and makes patients more prone to calcium deposition in soft tissues such as the coronary arteries, increasing the risk of ischemic heart disease. ily101 is a non-absorbed, metal-free polymer that binds phosphorus in the gastrointestinal tract, allowing for excretion of phosphorus. it is therefore anticipated to ameliorate hyperphosphatemia by reducing the absorption of phosphorus from the gastrointestinal tract.

Eligibility criteria:
inclusion criteria: * ckd patients on dialysis * prior successful use of phosphate binder * signed informed consent exclusion criteria: * previous intolerance to polymer-based phosphate binders * kidney transplant planned within 3 months * pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control * clinically significant liver disease * history of bowel obstruction or other significant gastrointestinal disorder additional study entry criteria will be evaluated during initial screening.

Keywords: hyperphosphatemia chronic kidney disease dialysis hyperphosphatemia in ckd patients on dialysis
efficacy study of chemotherapy followed by radiation therapy to treat endometrial cancer

Conditions: Endometrial Cancer

Summary: previous some studies suggested the addition of chemotherapy to radiation therapy after surgery may have survival benefit in patients with high risk endometrial cancer. in addition, docetaxel plus cisplatin regimen may have similar efficacy with paclitaxel plus carboplatin which is currently used in most cases. however, docetaxel plus cisplatin may cause less toxicity compared to paclitaxel plus carboplatin. therefore, the investigators aimed to analyze the efficacy of docetaxel plus cisplatin regimen followed by radiation therapy after surgery in patients with high risk endometrial cancer.


Eligibility criteria:
inclusion criteria: * one of following high risk groups stage iii after staging operation stage ii (type i hysterectomy + bso + lnd) stage i + two of \[grade iii, lvsi+, mm\>1/2\] clear cell or serous carcinoma: stage ib-ii * age: 20-75 * ecog ps: 0-2 * adequate organ function bm: wbc ≥ 3,000/mm3, anc≥1,500/mm3, plt≥100x103/mm3, hb≥10.0 g/dl kidney: creatinine \<1.25 × unl이고, gfr ≥ 60 liver: ast, alt\< 3×unl, t- bil\<1.5 mg/ mm3 * informed consent exclusion criteria: * previous chemotherapy or pelvic rt * hormone therapy within 4 weeks * other malignant disease * uncontrolled medical disease * infection requiring antibiotics * symptomatic chf, rf, angina, arrhythmia, etc. * neurosis or psychosis * etc.
the effect of chemotherapy on regulatory t cells

Conditions: Pre B ALL; Regulatory T Cell

Summary: the investigators aimed to study the effect of chemotherapy on regulatory t cells (tregs) in children with precursor b (preb) acute lymphoblastic leukemia (all) at 15 and 33 days of malignity directed therapy. the investigators will analyze peripheral and bone marrow blood samples of the participants, obtained at diagnosis, 15 and 33 days of treatment, about treg / non treg cells and interleukin (il)-2, il-6, il-10, and transforming growth factor (tgf) beta levels. by this means, investigators will search response to chemotherapy. also, investigators will analyze correlation between treg population-treg related cytokines with demographic, clinical and laboratory findings of the participants with all at these certain time points. additionally, the investigators will compare treg population and minimal residual disease at 15-33 days of malignity directed therapy. also investigators will compare these treg-treg related cytokines obtained from the participants with all and a healthy children control group whom are voluntary donors for bone marrow transplantation.


Eligibility criteria:
inclusion criteria: * children between 1-18 years * recent preb all diagnosis exclusion criteria: * children under 1 or over 18 years * underlying disease e.g. immune deficiency, germline mutations or diseases * tcell all or acute myeloid leukemia (aml) patients

Keywords: regulatory t cell acute lymphoblastic leukemia minimal residual disease
relationship between evolution of resting energy expenditure and tumoral response to chemotherapy in patients suffering from pancreas cancer

Conditions: Metastatic Pancreatic Cancer

Summary: the purpose of this study is to determine whether evolution of resting energetic expenditure is a predictive marker of tumoral response for patients suffering from metastatic pancreatic cancer and treated with 1st line of chemotherapy.


Eligibility criteria:
inclusion criteria: * pancreatic metastatic cancer * patient older than 18 years * initiation of a first line of chemotherapy by folfirinox, or gemcitabine or in combination with nab-paclitaxel. * at least one measurable target lesion * patient signed consent for energie-pancreas study participation exclusion criteria: * other concomitant cancer * major general status alteration ( performance status = 3 or 4 at inclusion) * concomitant diseases explaining an altered general status or having an impact on energetic expenditure (i.e.chronic or severe infection, severe cardiac insufficiency, severe respiratory insufficiency, chronic inflammatory disease, recent surgery (\< 1 month), ongoing healing, hyperthyroidism. * smoker * patient deprived of his liberty, under guardianship, curator. * pregnant patient or breastfeeding * claustrophobic patient

Keywords: energetic expenditure
closed-loop control of glucose levels in the context of exercise in adults with type-1 diabetes

Conditions: Type 1 Diabetes

Summary: recent developments of continuous glucose sensors and insulin infusion pumps have motivated the research toward closed-loop strategies to regulate glucose levels in patients with type 1 diabetes. in a closed-loop strategy, the pump(s) infusion rate is altered based on a computer-generated recommendation that relies on continuous glucose sensor readings. in this study, we aim to compare the effectiveness of dual-hormone (insulin+glucagon) closed-loop strategy to open-loop conventional continuous subcutaneous insulin infusion pump (csii) therapy in regulating glucose levels during an evening exercise and on a night following an exercise in adults with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 1 diabetes for at least one year. * on insulin pump therapy for at least 3 months. * hba1c ≤ 10%. exclusion criteria: * clinically significant nephropathy, neuropathy or retinopathy. * recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. * a recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol. * pregnancy. * severe hypoglycemic episode within two weeks of screening. * current use of glucocorticoid medication (by any route of administration except low dose stable inhaled). * known or suspected allergy to the trial products or meal contents. * other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator. * anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport). * failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
rfviia prophylaxis in children with hemophilia a and inhibitors

Conditions: Hemophilia A With Inhibitors

Summary: the study evaluates the efficacy and safety of a prophylactic treatment with recombinant activated fvii in reducing the frequency of joint bleeds and the development of joint damage in children with hemophilia a who develop high-titer inhibitors.

this is a multicentre, randomised, controlled study designed to gain evidence of the advantage of the prophylactic, daily treatment with recombinant activated fvii as compared to the conventional on demand therapy in reducing the bleeding frequency and preserving the orthopaedic status in hemophilic children with inhibitors.

Eligibility criteria:
inclusion criteria: * patients with hemophilia a who have been treated with factor viii on demand or on prophylaxis and who have developed inhibitors to factor viii * ≤ 2 years from the time of first inhibitor detection. * high-responding inhibitors (historical peak \> 5 bu/ml)and known anamnestic response in case of negative inhibitor titre. * candidates to start daily iti with fviii doses ranging from 50 iu/kg/day to 200 iu/kg/day * maximal two bleedings in the same joint within the last 6 months before entering the study or maximal six joint bleeds in the same joint within 2 years * adequate venous access for daily infusion and capable (caregiver) of reconstituting and injecting the study drug * informed consent by parents or legal guardians. exclusion criteria: * iti already started * known or suspected hypersensitivity to the active substance or to any of the excipients of the study drug * administration of any investigational product within 30 days prior to randomisation * other coagulation disorders than congenital hemophilia a. * family history of thrombosis at an early age (\< 40 years), known thrombophilia, any previous thrombosis including catheter-related deep vein thrombosis, previous neonatal thrombosis. * known pseudo tumours * known severe liver disease * platelet count \< 50,000 platelets/µl at screening * surgery within one month or planned major and/or orthopaedic surgery.

Keywords: hemophilia a inhibitors prophylaxis immune tolerance induction
effects of probiotics on streptococcus mutans ve lactobacillus spp

Conditions: Tooth Decay; Probiotics; Streptococcus Mutans

Summary: to evaluate the change of s. mutans and lactobacillus spp. counts after all dental treatments were completed under general anesthesia and compare the groups in case of using probiotics and not using probiotics with the time for 6-months follow-up period.

fifthy-eight pediatric patients without any systemical diseases whose dental treatments were completed under general anesthesia were included in the study. the study was carried out as two-groups; group a: patients who started using probiotics after general anesthesia and group b: patients who did not use probiotics after general anesthesia. the counts of s. mutans and lactobacillus spp. were determined by quantitative polymerase chain reaction (qpcr) by analysis of saliva samples taken from all patients on the day before the general anesthesia (t0), at 1-month (t1), 3-month (t2) and 6-month (t3) follow-up periods. the statistical significance level was accepted as p\<0.05.

Eligibility criteria:
inclusion criteria: * every included child had at least 8 tooth with caries. exclusion criteria: * patients who would not be able to give saliva samples due to high anxiety or lack of saliva were not included in this study.

Keywords: tooth caries probiotics qpcr streptococcus mutans lactobacillus
electronic-health application to measure outcomes remotely clinical trial

Conditions: Neurodegenerative Disease; Weight Loss; Amyotrophic Lateral Sclerosis; Parkinson's Disease; Huntington's Disease; Cachexia

Summary: this is a phase ii feasibility, safety, tolerability and preliminary efficacy study of an e-health application versus in-person nutritional counseling to maintain or increase weight in patients with neurodegenerative diseases including amyotrophic lateral sclerosis (als), parkinson's disease (pd) and huntington's disease (hd). primary objectives include the feasibility, safety, tolerability and efficacy of an e-health application to maintain or increase body weight compared to in-person nutritional counseling. secondary objectives are to measure the number of calories required to maintain or increase body weight in neurodegenerative diseases at all stages of the disease. tertiary objectives are to test the effects of an e-health application compared to in-person nutritional counseling on disease progression using the alsfrs-r, uhdrs or udysrs, on survival, and on quality of life using the promis sf v1.1 scale.

this is a single center, randomized, open-label, placebo controlled, parallel group study. the study treatment period is approximately 6 months and observation period is approximately 7 months. there are three parallel treatment groups: in-person nutritional counseling, nutritional counseling using an e-health app, and standard care. subjects will be randomly assigned in a 1:1:1 ratio using a computer-generated randomization scheme. subjects in the two intervention arms will be given caloric recommendations designed to cause weight stability or modest weight gain, depending on their current bmi and weight loss history. all participants in the intervention arms will receive counseling either in-person or remotely through the app by registered dietitians (rd) working in the bionutrition department of the clinical research center at mgh. at mgh, approximately 150 als subjects (50 per treatment group) will be enrolled. approximately 75-150 pd and hd subjects will enroll.

Eligibility criteria:
inclusion criteria: 1. adults with neurodegenerative diseases such as als, pd or hd with or without a history of unintentional weight loss. 2. male or female subjects aged 18 years or older. 3. participants must be capable of providing informed consent and complying with trial procedures. 4. participants must have an mgh swallowing screening tool score\>5 at the time of the screening visit 5. participants or a designated caregiver must be able to obtain home weights and communicate to their rd exclusion criteria: 1. clinical evidence of unstable medical or psychiatric illness, in the investigator's judgment, which would prevent the participant from completing their assessments. 2. bmi \> 35 combined with a history of cardiovascular disease; or a history of diabetes regardless of bmi.
study to assess the efficacy, safety, and tolerability of noc-110 in adults with refractory or unexplained chronic cough

Conditions: Refractory or Unexplained Chronic Cough

Summary: this is a phase 2b, randomized, double-blind, placebo-controlled study investigating the efficacy, safety, and tolerability of taplucainium inhalation powder (noc-110) once daily in adults with refractory or unexplained chronic cough.

approximately 325 participants will take part in the study. it is anticipated that up to 600 participants will be screened. participation will be approximately 13 weeks.

Eligibility criteria:
inclusion criteria: * refractory or unexplained chronic cough for ≥ 12 months. * women of childbearing potential agree to follow the protocol specified contraceptive - guidance during the study. * males who are not vasectomized must agree to use the contraceptive methods defined in the protocol. * able to provide informed consent. exclusion criteria: * previous exposure to taplucainium (formerly ntx-1175) or known allergy or hypersensitivity to taplucainium, its excipients/metabolites, or related compounds. * participants who are currently participating in another drug or device clinical study * participants who have participated in an acute or chronic cough investigational study within 60 days before the start of the screening. * current diagnosis of chronic obstructive pulmonary disease, bronchiectasis, unexplained pulmonary fibrosis, hemoptysis, bronchial asthma, or other pulmonary disease. * respiratory tract infection within 4 weeks of screening or during screening period. * any female who is pregnant or lactating or wishing to become pregnant. * donation of \> 1 unit (450 milliliter or more) of blood within 90 days prior to the first dosing. * alcohol or drug use disorder within the past 2 years. * current smoker/vaper or individuals who have given up smoking within the past 6 months, and/or those with \>20 pack-year smoking history. * current opiate/opioid use or medical history of opiate/opioid use disorder. history of concurrent malignancy or recurrence of malignancy in the last 2 years. * body mass index of ≥40 kg/m2. * positive results for human immunodeficiency virus, hepatitis b, or hepatitis c virus. * unable to refrain from the use of medications and treatments that can impact cough during the study. * have clinically significant history or evidence of poorly controlled cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s).