Kornimate/medical-research-clean huggingface dataset:
dietary intervention and gastrointestinal function in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: in this prospective, intervention study, participants with diagnosed parkinson's disease will be instructed to follow a mediterranean diet for five weeks. gut permeability will be assessed using food-grade sugar molecules. participants will provide urine and stool samples to assess gut permeability and microbial communities.


Eligibility criteria:
inclusion criteria: * physician-diagnosed parkinson's disease aged 21-85 years * hoehn \& yahr stage \<3 * currently living in the same household with a healthy spouse/partner who meets study eligibility criteria and is willing to participate * willing and able to complete informed consent in english * willing to complete daily and weekly questionnaires and 6 dietary recalls over approximately 7 weeks * willing to avoid beer, wine, and cocktails on the day before and the day of the sugar probe tests. * willing to provide urine and stool samples during the study collection periods. * willing and able to fast (no food or drink, except water or tea) for a prolonged period of time during study urine collections. * willing to maintain usual diet through the pre-baseline period * willing to make dietary changes to follow a mediterranean dietary pattern during the intervention period. * willing to discontinue taking prebiotic, fiber, probiotic, herbal, or high-dose vitamin or mineral supplements that may impact inflammation during the pre-baseline period and throughout the study protocol. * willing to limit use of oral laxative medication to an "as-needed basis" (i.e. \<3 times per week) during the full length of the study * willing to avoid high intensity exercises two days prior to and the day of the permeability tests. these tests will be done on two occasions. * willing to provide a social security number to receive study payment. exclusion criteria: * does not meet above criteria * atypical or secondary parkinsonism * history of deep brain stimulation * daily use of nsaids in the last 3 months or incidental use in the last 2 weeks prior to screening. * daily use of anticholinergics or prokinetic agents * use of enemas or suppositories to alleviate constipation * use of another investigational product within 3 months of the screening visit. * antibiotic use within 2 months from the day of stool collection * good adherence to the mediterranean diet during the pre-baseline period (score \>6) based on the 14-item mediterranean diet assessment tool * physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, crohn's disease, gastroparesis, cancer, peptic ulcer disease, celiac disease, short bowel disease, ileostomy, colostomy) other than gastroesophageal reflux or diverticular disease

Keywords: intestinal permeability mediterranean diet leaky gut intestinal barrier function
mesenchymal stem cell therapy for bronchopulmonary dysplasia in preterm babies

Conditions: Bronchopulmonary Dysplasia

Summary: bronchopulmonary dysplasia (bpd) is the most frequent disease related to a premature birth, 15-50% of very low birth newborns (\<1500 gr.) will develop bpd. the prevalence of bpd is increasing due to the advances in neonatology, with a rise in the survival of smaller and more premature babies. the etiology of bpd is multifactorial, in which oxygen, maternal chorioamnionitis, insufficient pulmonary maturation etc. have an important role. these factors lead to a pathological development of the lung and pulmonary vessels, developing secondary pulmonary hypertension (ph). nowadays there is no efficient treatment; this generates a important sanitary burden and a decrease in life quality. multiple experimental models in mice have studied mesenchymal stem cell (msc) therapy as prevention of bpd, also recently some clinical trials have tried this therapy on premature newborns with promising results. hypothesis: msc therapy in patients at high risk of bpd prevents pulmonary lesions. methods: the investigators have designed a clinical trial to evaluate the feasibility and security of msc therapy in patients at high risk of developing bpd.


Eligibility criteria:
inclusion criteria: * preterm newborns ≤ 28 weeks gestational age * birth weight \<1250 gr. * still on of mechanical ventilation fio2 \> 0,3 at day + 14 exclusion criteria: * other congenital pathology (pulmonary malformations, active pulmonary bleeding, renal malformations, chd, malformative syndromes, chromosomopathies) * severe neurological lesion. * hiv infection * cardiovascular instability due to any cause * 72 hours after mayor surgery * necrotizing enterocolitis grades ii or higher, according to bell classification, at the time of inclusion.

Keywords: bronchopulmonary dysplasia pulmonary hypertension stem cell therapy mesenchymal stem cells very low weight preterm babies
a study to investigate the efficacy and safety of tezepelumab in adult participants with moderate to very severe copd (d5241c00007)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: a multicenter, randomized, double-blind, placebo-controlled, parallel group, phase 3 study to evaluate the efficacy and safety of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (copd)

this is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (copd) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, copd exacerbations in the 12 months prior to visit 1. subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. the study also includes a off-treatment safety follow-up period of 12 weeks.

Eligibility criteria:
inclusion criteria: 1. ≥40 to ≤80 years old 2. copd diagnosis ≥1 year, 3. post-bd fev1 ≥ 20% and ≤ 70% pn, fev1/fvc \<0.70 at screening 4. triple (ics+laba+lama) or dual inhaled copd therapy ≥3 consecutive months prior to v1 5. ≥2 moderate or ≥1 severe copd exacerbations in the prior year; at least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids 6. eos ≥ 150 cells/μl during screening 7. cat ≥15 at screening 8. former or current smokers ≥10 pack-years exclusion criteria: 1. clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than copd 2. asthma, incl. pediatric, or acos 3. any unstable disorder that can impact participants safety or study outcomes 4. tuberculosis requiring treatment within 12 months prior v2 5. malignancies current or past concomitant therapies: * macrolides (less than 6 months) * systemic immuno-suppressive, -modulating medications 6. ltot \>4.0 l/min or o2 saturation \<89% despite ltot

Keywords: copd moderate copd severe copd very severe copd chronic obstructive pulmonary disease
safety and efficacy of non-alcoholic beverage based on kombucha in patients with constipations

Conditions: Irritable Bowel Syndrome With Constipation; Constipation-predominant Irritable Bowel Syndrome

Summary: single centre, open-label, non-randomized study is planned to proof the concept of safety and efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage based on kombucha, enriched with inulin and vitamins in patients with constipations

this single-center open-label non-randomized study is planned to proof the concept on safety and efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage based on kombucha, enriched with inulin and vitamins in patients with irritable bowel syndrome with constipations.

Eligibility criteria:
inclusion criteria: * willingness to participate (based on signed informed consent form) * irritable bowel syndrome with predominant constipation, per rome iv criteria (recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria: related to defecation; associated with a change in frequency of stool; associated with a change in form (appearance) of stool - bristol stool scale types 1 or 2. criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis), exclusion criteria: * pregnant or breast-feeding women; * intolerance of kombucha or any component of the product; * history of abdominal surgery; * the use of concomitant medications able to affect bowel motility; * general condition of a patient making the appropriateness of his participation in the study questionable; * chronic decompensated disorders of any organs and systems; * mean daily caloric intake less than 800 kcal and more than 6000 kcal * inability to follow standard iso-caloric diet and standard volume of water consumption (1.5-2 litres a day)

Keywords: specialized food product kombucha safety efficacy constipation functional food
a follow-up study to evaluate the safety of allo-asc-cd in allo-asc-cd-101 clinical trial

Conditions: Crohn Disease

Summary: this is an open-label follow up study to evaluate the safety for the subjects with allo-asc-cd injection in phase 1 clinical trial (allo-asc-cd-101) for 36 months.

this is an open-label follow up study to evaluate the safety for the subjects with allo-asc-cd injection in phase 1 clinical trial (allo-asc-cd-101) for 36 months. allo-asc-cd is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells. adipose-derived stem cells are directed to injured tissue, and reduce inflammation. furthermore their immunomodulatory effects are significant for treating immune-related disease, such as crohn's disease. finally, allo-asc-cd may provide a new option in treating a crohn's disease.

Eligibility criteria:
inclusion criteria: 1. subjects who are injected with allo-asc-cd in phase 1 clinical trial of allo-asc-cd-101. 2. subjects who are able to give written informed consent prior to study start and to comply with the study requirements. exclusion criteria: 1. subjects who are considered not suitable for the study by the principal investigator.
smoking interventions in general medical practices

Conditions: Tobacco Smoking; Nicotine Dependence

Summary: primary care physicians can play an important role in reducing tobacco smoking in the population. the general practice is a suitable setting for implementing proactive smoking interventions, because a large proportion of the population can be regularly reached in a favorable psychological state. further, a trustful interpersonal relationship between the practitioners and their patients is supposed to increase the susceptibility to preventive measures. however, currently general practitioners are not capitalizing this advantage although evidence based treatments are available, which are effective and cost-effective. outreach programs combining educational and practice-based measures have been found to be effective in engaging practitioners in screening and in giving advice. computer expert-system and brief counseling interventions, which are based on the transtheo-retical model of behavior change (ttm), are promising approaches for the entire population of practitioners and smoking patients. for large scale implementation, data are needed about the degree of integration in every day routine clinical practice that could be achieved by implementing such interventions. objectives: evaluating different strategies for the implementation of proactive smoking interventions in general practices. methods: in a randomized controlled trial, 150 randomly selected general practices of a defined german region will be included. the procedure comprises the implementation of 1) an on-site computer expert-system intervention, 2) a counseling intervention provided by the practitioner, or 3) the computer expert-system plus the counseling intervention. during an implementation phase of one month, two on site training sessions and support by phone will be provided. routine use of the interventions will be monitored for the following 6 months. main outcome measures are the number and rate of identified and treated smokers. a follow-up assessment will be realized 12 months after practice attendance to determine the smoking status of the treated smokers.


Eligibility criteria:
inclusion criteria: * practices with regular office hours * practices predominantly providing primary medical care for adults * patients with age 18 and older * patients with sufficient german language and cognitive capabilities to complete assessment * patients smoking within the preceding six month exclusion criteria: * practices planing closure within the next 12 months * practices opening less than 12 months ago

Keywords: primary medical care computer expert system motivational interviewing health behavior change counselling stages of change
dietary nitrate functional gum effect on gingivitis and heart health

Conditions: Gingivitis; Cardiovascular Diseases; Gingival Diseases; Gingival Bleeding; Periodontal Diseases

Summary: the purpose of this research is to determine the effects of a chewing gum containing dietary nitrate to gingival and heart health. dietary nitrates are commonly found in leafy vegetables and beets. the information learned from the study may help further understand the interconnection of oral health and heart health. the study is looking for individuals who present with mild to moderate gum irritation or bleeding. in the study participants will be randomized into either a group that will use a chewing gum containing dietary nitrate, or use a placebo chewing gum during a three-week period. participants in the study will have a simple gingival exam, x-rays if needed, and small samples of saliva and blood collected. all participants will also undergo a routine tooth cleaning. participants will be asked to breathe in a tube to sample the levels of nitric oxide. finally, participants will have their heart health measured with a device that is like a blood pressure cuff.

the purpose of the project is to characterize, in subjects with gingival inflammation, the effect of a prebiotic dietary nitrate formulated chewing gum on the oral microbiome. in order to assess this, gingival health and parameters related to vascular health are observed: the study is testing the hypothesize that short term use of functional gum will have improved inflammatory measures of the gingiva and beneficial cardiovascular impact. the study hopes to discover if any observed changes to oral and cardiovascular measures may be associated to changes to oral microbiome composition.

Eligibility criteria:
inclusion criteria: * adult subjects with mild to moderate gingivitis, defined with a mgi score of at least 2.0 * subjects must have a minimum of 20 natural teeth * subjects must be able to chew gum exclusion criteria: * significant alveolar bone loss (\>3.0 mm cej to bone) * requirement for antibiotic pre-medication prior to dental procedures * systemic antibiotic use in past 14 days to current. * use of anti-inflammatory (nsaids) or in past 14 days * use of anticoagulant therapy or in past 14 days. * current smokers * pregnancy * use of any oral rinses such as, but not limited to chlorhexidine, essential oils, cetylpyridinium chloride during the study.

Keywords: gingivitis dietary nitrate periodontal disease
management of symptomatic advanced pancreatic adenocarcinoma

Conditions: Pancreas; Management Supportive Care Program

Summary: this study assessed the feasibility and effects of an early integrative supportive care program in patient with advanced pancreatic adenocarcinoma (apdac).

this is a national, multicenter, prospective study, including: * a 14-day (+/-2 days) integrative supportive care program (14-eiscp) initiated as early as the clinical suspicion of apdac, * follow-up period after the 14-eiscp. ecog ps ≥2 patients with pathologically confirmed or suspected apdac on imaging were included at first oncology visit in the 14-eiscp including pain, nutritional, diagnostic and stenting procedures. post-eiscp ecog ps ≤1 patients received mfolfirinox or gemcitabine/nab-paclitaxel, ecog ps ≥2 patients received mfolfox7 or investigator choice chemotherapy or best supportive care.

Eligibility criteria:
inclusion criteria 1. pathologically confirmed or highly suspected apdac defined as a pancreatic mass on imaging, suspected distant metastases, no features suggestive of a neuroendocrine tumor, and/or clinico-biological abnormalities compatible with the diagnosis of apdac, 2. age ≥ 18 years, 3. patients with ecog ps ≥ 2 and clinico-biological features precluding initial therapeutic clinical trial and/or treatment with folfirinox or gemcitabine + nab-paclitaxel, 4. no prior history of cancer, except: in situ breast, cervix cancer, or basal cell carcinoma and/or complete remission for more than 3 years from another cancer. 5. registration in france with the french national health care system (cmu included) 6. patient able to comply with study protocol requirements in the view of the investigator, 7. before patient registration, written informed consent must be obtained according to ich/gcp and national/local regulations, 8. patients requiring at least two components of the integrative care program (pain management, nutritional management, pathological assessment or imaging, and endoscopy/stent). exclusion criteria: 1. any medical, psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial, 2. patient protected by law, 3. pregnant or breast feeding women
treatment of hyperpyrexia and in the pediatric emergency department (fever_ed)

Conditions: Fever

Summary: fever represents the main cause of admission to the emergency room in older people pediatric. it occurs in the presence of a wide range of pathologies, from infectious forms (the most common, viral or bacterial) up to more complex and/or systemic forms (such as inflammatory or neoplastic ones). the drugs currently indicated for the management of fever in children are: paracetamol and ibuprofen. there are no recent studies conducted in pediatric population, who have demonstrated the greater effectiveness of therapy with paracetamol or ibuprofen, the objective of our study is, therefore, to identify which therapy is most appropriate for controlling body temperature e of associated symptoms in pediatric patients arriving in the emergency room with fever.


Eligibility criteria:
inclusion criteria: * pediatric patients (aged between 6 months 0 and 20 years) * fever (t \&gt; 38°c) with/without associated symptoms, treated with standard antipyretic drugs orally (paracetamol, ibuprofen or paracetamol/ibuprofen combination) * who have expressed their consent to participate in the study. exclusion criteria: * age \&lt;6 months or \&gt;20 years; * patients who did not express consent to participate in the study
use of nirs in preterm population born at altitude

Conditions: Prematurity; Extreme

Summary: near-infrared spectroscopy (nirs), is a technology that can provide continuous, non-invasive monitoring of oxygenation in tissue. the objective of this study is to obtain the cerebral regional oxygen saturation (crso2) in a preterm population that is born at altitude to determine if the range of "normal" values is different than those obtained at sea level.


Eligibility criteria:
inclusion criteria: * infant must be \<32 weeks' gestational age at time of delivery. * consenting mother/guardian of the infant must speak english. other languages are not being included due to the need of a translator being brought into the unit, which adds risk to the vulnerable population. additionally, as the time to consent is a narrow window, adding the complexity of getting a translator may delay the ability to get consent and thus make it more difficult to enroll patients. * infants that require blood transfusions during the monitoring time may be included. exclusion criteria: * any known cardiac anomaly or other anomaly which may impair perfusion and blood flow. * infant born after placental abruption or concern for extreme blood loss immediately after birth. * unable to consent the mother/guardian due to maternal health issues after delivering (eg requiring intubation or sedation after the delivery). * mothers/guardians that are prisoners, as the study team would like to have continuing communication with the mother during the study period as needed. * mothers/guardians that are \<18 years of age will not be approached for consent. * any mother/guardian that is not able to consent due to having a legal representative will not be approached for consent in this study. * any infant that is planned to be placed for adoption * infant is greater than 24 hours of age at time of consent.
a study of ly2928057 in hemodialysis participants

Conditions: Renal Insufficiency, Chronic; Kidney Disease, Chronic

Summary: this study will evaluate the safety of ly2928057 and how ly2928057 affects hemoglobin in hemodialysis participants. this study will involve multiple doses of ly2928057 given during a 6 week period either after a participant discontinues or reduces treatment to stimulate red blood cells. this study will last up to 26 weeks for each participant.


Eligibility criteria:
inclusion criteria: * participants having end-stage renal disease (esrd), have received an erythropoiesis stimulating agent (esa) at least weekly for 2 weeks prior to screening, and have been receiving adequate maintenance hemodialysis (3 times weekly) for at least 12 weeks prior to screening (that is, an approximate kt/v greater than 1.1 (k equals dialyzer clearance of urea, t equals dialysis duration time, v equals volume of distribution of urea, which is approximately equal to the participant's total body water) based on the clinical judgment of participant's nephrologist and investigator and who are willing to stop (parts a and b) or reduce (part c) their stable esa dose from the week of randomization until completion of the 6-week treatment period (unless rescue therapy is needed) * have a hemoglobin value (taken prior to dialysis if taken on a dialysis day) greater than or equal to 9.5 grams per deciliter (g/dl) and less than or equal to 12.5 g/dl at screening * have a body mass index (bmi) of 18.5 to 45 kilograms per square meter (kg/m\^2) inclusive at screening * have a transferrin saturation (tsat) greater than or equality to 15 percent and ferritin greater than 40 nanograms per milliliter (ng/ml) at screening exclusion criteria: * any cause of anemia other than renal disease * a history of hyporesponsiveness to esa
tri102 in the treatment of children with attention deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the purpose of this study is to determine whether tri102 is effective in the treatment of attention deficit hyperactivity disorder (adhd) in children ages 6-12.

a phase 3, randomized, double-blind, placebo-controlled, parallel group, multicenter, laboratory classroom study. after screening and baseline evaluations, eligible subjects are enrolled in the study and entered the open-label phase, dose-optimization phase. tri102 is taken once daily and subjects undergo dose optimization activities for 5 weeks.

Eligibility criteria:
inclusion criteria: * children aged 6 to 12 years with adhd who require pharmacologic treatment for this condition exclusion criteria: * other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of adhd