Kornimate/medical-research-clean huggingface dataset:
study to evaluate tezepelumab in adults with severe uncontrolled asthma

Conditions: Asthma

Summary: a regional, multicentre, randomized, double-blind, placebo controlled, parallel group, phase 3 study to evaluate the efficacy and safety of tezepelumab in adults with severe uncontrolled asthma

this is a regional, multicentre, randomized, double-blind, placebo controlled, parallel group, phase 3 study designed to evaluate the efficacy and safety of 210 mg q4w (sc) of tezepelumab in adults with severe, uncontrolled asthma on medium to high-dose ics and at least one additional asthma controller medication with or without ocs. approximately 396 participants will be randomized regionally (china/non-china). participants will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period. the study also includes a post-treatment follow-up period of 12 weeks

Eligibility criteria:
inclusion criteria: * age. 18-80 * documented physician-diagnosed asthma for at least 12 months * participants who have received a physician-prescribed asthma controller medication with medium or high dose ics for at least 6 months. * documented treatment with a total daily dose of either medium or high dose ics (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months. * at least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months. * morning pre-bd fev1 \<80% predicted normal * evidence of asthma as documented by either: documented historical reversibility of fev1 ≥12% and ≥200 ml in the previous 12 months or post-bd (albuterol/salbutamol) reversibility of fev1 ≥12% and ≥200 ml during screening. * documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ics. * acq-6 score ≥1.5 at screening and on day of randomization exclusion criteria: * pulmonary disease other than asthma. * history of cancer. * history of a clinically significant infection. * current smokers or participants with smoking history ≥10 pack-yrs. * history of chronic alcohol or drug abuse within 12 months. * hepatitis b, c or hiv. * pregnant or breastfeeding. * history of anaphylaxis following any biologic therapy. * participant randomized in the current study or previous tezepelumab studies.

Keywords: asthma uncontrolled asthma severe uncontrolled asthma
probiotics for irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the study aims to investigate the effect of probiotics on ibs-patients symptoms compared to placebo, when given for 6 months. by draw the investigators give ibs patients, in the age of 18-50 years, capsules with either probiotics or placebo. the patients are to take 2x2 capsules / day for 6 months. the patients are followed for 1 year. they are seen after 3, 6 and 12 months, and are followed by means of monthly letters. the capsules contain 3 different probiotic strains - lactobacillus paracasei ssp paracasei f19, lactobacillus acidophilus la5 and bifidobacterium bb12. the dose is 2 x 109 - 10 x 109 cfu/capsule. the hypothesis is, that there is a clinical difference between the group receiving probiotics and the group receiving placebo.

background: in management of ibs, no treatments have showed great efficacy. ibs is a non-fatal disease, so safety is a high priority in the choice of treatment. probiotics is a dietary supplement and have no adverse effects. in some studies it has shown beneficial effect on some of the ibs patients symptoms, but some of the results are questionable. the studies have to be of longer duration, with more patients and the probiotics have to be capsules instead of milk based drinks.

Eligibility criteria:
inclusion criteria: * fulfill rome iii criteria * age 18-50 years * signed informed content exclusion criteria: * danger signals (fever, anaemia, weightloss, blod in stools, predisposition for crc or ibd) * abnormal physical examination * comorbidity * abuse * lacking ability to talk and understand danish * pregnancy * for patients \> 40 years. changed bowel habits, with duration \> 3 weeks, but \< 1 year

Keywords: ibs irritable bowel syndrome probiotics treatment adequate relief
effect of abdominal massage on bowel movements in patients with subarachnoid hemorrhage

Conditions: Subarachnoid Haemorrhage (SAH)

Summary: the study will be conducted as a randomized controlled trial to determine the effect of postoperative abdominal massage on bowel movements in patients who underwent surgery after subarachnoid hemorrhage and are hospitalized in the neurosurgery intensive care unit.

the study will be conducted as a randomized controlled trial to determine the effect of postoperative abdominal massage on bowel movements in patients who underwent surgery after subarachnoid hemorrhage and are hospitalized in the neurosurgery intensive care unit. the sample of the study will consist of a total of 64 patients, 32 in the experimental group and 32 in the control group, hospitalized in the tertiary neurosurgery intensive care unit. data collection tools are the "descriptive characteristics form" and the "patient follow-up form".the statistician will determine whether the patients who meet the sampling criteria will be assigned to the experimental or control group through randomization. the stratified randomization method will be used in the study. in this context, patients who meet the inclusion criteria from the start date of the study in the neurosurgery intensive care unit will be randomized by assigning them to the control group and abdominal massage groups, respectively. patients will be assigned to the control and abdominal massage groups in this order until the sample size is reached. the consort diagram will be used in the randomization of patients.

Eligibility criteria:
inclusion criteria: * • 18 years of age or older * underwent neurovascular surgery * received general anesthesia * have no wounds, surgical intervention, or radiotherapy in the abdominal region * have no bowel obstruction, irritable bowel syndrome, inflammatory bowel disease, abdominal herniation, or bowel cancer * began oral feeding at the 6th hour post-surgery * stayed in the intensive care unit for 3 or more days * have a glasgow coma scale (gcs) score of 9 or above * have no signs of acute abdomen * have no intra-abdominal infection * no mechanical ventilation * mobilezed in the preoperative period * unable to mobilize after surgery * evaluated by the intensive care physician with no contraindications for abdominal massage * have a first-degree relative who has given consent exclusion criteria: * patients with the following conditions will be excluded from the sample: * those with chronic constipation, fecal incontinence, or diarrhea * those fed with a fiber-enriched nutritional solution (e.g., nutrison protein plus multifibre®, fresubin original fibre®, isosource fiber®, jevity plus®) * those fed via nasogastric enteral tube * those receiving parenteral nutrition * patients with a bmi \> 40 (morbid obesity)

Keywords: subarachnoid hemorrhage abdominal massage bowel movements nursing
exploring the effects of aquatic exercise on cardiovascular function in older adults

Conditions: Cardiovascular Diseases

Summary: cardiovascular ageing is implicated in the development of cardiovascular disease (cvd). aquatic exercise is being considered as a co-adjuvant form of rehabilitation, but there is limited evidence for its cardiovascular risk-reduction properties for older people. our study aims to address this by exploring the cardiovascular effects of long-term aquatic exercise in older adults in comparison to those who are either inactive or engaged in land-based/mixed training by measurement of micro- and macro-circulation.


Eligibility criteria:
inclusion criteria: * being over 55 years of age and normotensive (e.g., \<140/90 mm hg). exclusion criteria: * any overt chronic disease which would affect microvascular functioning, * anaemia (irrespective of whether an iron supplementation course is followed or not) * a recent (3 months' ago) major surgery * none of the participants were undertaking high intensity interval training of any form.
tislelizumab in combination with pre-operative crt versus soc for locally advanced g/gej adenocarcinoma

Conditions: Gastric Cancer; Gastroesophageal-junction Cancer

Summary: the purpose of this study is to evaluate the efficacy of tislelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (gej) adenocarcinoma. the primary study hypotheses are that: neoadjuvant and adjuvant tislelizumab plus chemoradiotherapy, followed by adjuvant tislelizumab and chemotherapy is superior to neoadjuvant chemoradiotherapy or chemotherapy, followed by adjuvant chemotherapy in terms of rate of pathological complete response (pathcr) at the time of surgery.


Eligibility criteria:
inclusion criteria: 1. has previously untreated localized gastric or gej adenocarcinoma as defined by t3\~4an+m0 or t4bnanym0 （ajcc version 8） 2. has an eastern cooperative oncology group (ecog) performance status score of 0 to 1 3. has adequate organ function. 4. male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy. 5. female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater. exclusion criteria: 1. has a known additional malignancy that is progressing or has required active treatment within the past 5 years. note: participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded. 2. has received prior systemic anti-cancer therapy including investigational agents for the current malignancy. 3. has an active infection requiring systemic therapy. 4. has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. 5. is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. 6. has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study treatment. 7. has an active autoimmune disease that has required systemic treatment in past 2 years. 8. has a known history of human immunodeficiency virus (hiv) infection. 9. has a known history of hepatitis b or known active hepatitis c virus infection (hbsag positive with hbv dna≥500 iu/ml；hcv：hcv antigen positive with hcv copies \>uln). 10. has had an allogenic tissue/solid organ transplant. 11. has received a live vaccine within 30 days prior to the first dose of study treatment. 12. female participants who are breastfeeding.
microbiota footprint and frailty phenotype in virologically suppressed people living with hiv

Conditions: HIV Infections

Summary: analysis of gut microbiota becomes more and more accessible in recent years. experimental data in both animal and human studies have demonstrated that imbalance of the gut microbiota which is called symbiosis may participate in an accelerated procedure of ageing as well as the expression of frailty phenotype. people living with hiv (plhiv) present markers of phenotypic frailty on average 10 years before uninfected people. in this population structural and functional modifications of galt (gut associated lymphoid tissue) are observed early after hiv infection and persist despite virological suppression on art (antiretroviral treatment). these galt modifications are associated with microbial translocation that is also correlated with immune activation and dysbiosis. the objective of study is to explore gut microbiota of plwh over 5 years, as well as to study associations of its longitudinal evolution with frailty markers and burden of comorbidities.


Eligibility criteria:
inclusion criteria: * individuals infected with hiv in the stable phase of their disease (absence of disease outbreak and absence of therapeutic modification within 3 months before inclusion), * subject with ongoing hiv follow-up on an outpatient basis (outpatient or day hospital consultation) in the participating center, and having virological suppression at the threshold of 50 copies / ml for at least 5 years (tolerance of blips \< 200 copies / ml during this period) * aged ≥ 55 at baseline * cd4 + t cell nadir\> 200 / mm3 * giving free and informed written consent * being affiliated with or benefiting from a social security scheme. exclusion criteria: * persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within two months before stool sampling. * subject not followed regularly in the participating center, * subject only coming for full hospitalization * subject in the primary infection phase of less than 1 year
app-based recording and optimization of the nutritional status in patients with head and neck tumors during and after radio(chemo)therapy

Conditions: Squamous Cell Carcinoma of Head and Neck

Summary: patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. the aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition.

patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. the aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition. patients in the experimental arm receive the daily reminder message via app (emento) that they should pay attention to adequate caloric intake. in addition, these patients receive 3 screening questions about their current health and nutritional status twice a week. in case of relevant deterioration (any negative value in the screening questions is explained under study procedure), additional further questions are asked, which are specifically aimed at the side effects of the tumor therapy (mainly dysphagia, pain). the answers will be transmitted to the radiation clinic. if a question is answered positively, this is reported to the radiotherapy clinic on the one hand and on the other hand, the patient is asked to consult the doctor in the clinic as soon as possible.

Eligibility criteria:
inclusion criteria: * patients with squamous cell carcinoma in the head and neck region, who receive a postsurgical or definitive radio(chemo)therapy * patients who have a smartphone on which the emento app can be installed * minimum age 18 years exclusion criteria: * patients who are represented by a legal guardian * patients who are not suitable for participation in the study due to a language barrier
long-term clinical and biological evaluation of patients with severe forms of pemphigus treated by rituximab

Conditions: Pemphigus

Summary: the purpose of this study is to study the midterm clinical evaluation, biological parameters and immune reconstitution after rituximab treatment for pemphigus.


Eligibility criteria:
inclusion criteria: * age\>18 * consentment * patient treated with rituximab and included in clinical trial n°2002/020/hp - nct00213512 "treatment of patients presenting pemphigus with anti cd20 (mabthera)". exclusion criteria: * age \< 18 * no consentment

Keywords: pemphigus mabthéra (r) b lymphocytes desmogleines
stress and gingival inflammation in non-pregnant and pregnant women

Conditions: Periodontal Diseases; Pregnancy Gingivitis

Summary: background: the purpose of the present study is to research whether stress scale scores alter with relationship to gingival inflammation and examine the impact of non-surgical periodontal therapy during pregnancy on the levels of cytokines in gingival crevicular fluid (gcf) and on salivary stress-related hormones. methods: 30 non-pregnant (control group) and 30 pregnant women (test group) who fulfilled the study inclusion criteria were chosen. the participants with moderate/severe gingivitis were included. clinical data and samples of gcf and salivary were collected at baseline and after periodontal therapy. the levels of cytokines interleukin-1 beta (il-1β) and il-10, and concentration of salivary chromogranin a (cg a) hormone were analyzed by enzyme-linked immunosorbent assay kits.

periodontal clinical measurements and periodontal treatment were applied by a previously trained and calibrated examiner. clinical parameters measurements including; probing pocket depths (ppd; the distance from the gingival margin to the base of the gingival sulcus), clinical attachment level (cal), full mouth gingival index (gi)21 and plaque index (pi)20 scores using a periodontal probe were registered following saliva and gcf sample collection. then, non-surgical periodontal therapy (npt) consisted of scaling, root planning, and oral hygiene instruction was applied. clinical measurements, recruitment of gcf, and saliva samples were repeated after three weeks. gingival crevicular fluid and saliva sample collection selected anterior teeth for gcf sampling were isolated from saliva using cotton rolls, a gentle stream of air was conducted parallel to the root surface for 5 to 10 seconds to dry the area. the periopaper strips were gently inserted into the gingival crevice until resistance was felt and were left in place for 30 s and were collected from mesio-buccal sulcus of teeth in the anterior region of each patient (two samples per patient and per visit). the samples containing blood were discarded and were placed in sterile eppendorf tubes and were stored at -20°c until the assay procedure.

Eligibility criteria:
inclusion criteria: 1. must be systemically healthy; 2. must be at least twenty teeth in the mouth; 3. clinical diagnosis of gingivitis; 4. must be the probing pocket depth (ppd)≤3 mm in all four quadrants. exclusion criteria: * the use of anti-inflammatory, * antimicrobial and hormone therapy within the preceding 6 months, * having psychiatric disorders, * a systemic disease, * smoking cigarettes and * for the control group breastfeeding, pregnancy and menstrual periods.

Keywords: chromogranin a, stress, gingivitis, pregnancy
a study to assess the safety and immune response of quadrivalent seasonal influenza vaccine (fluarix tetra) in participants aged 65 years and older in india

Conditions: Influenza, Human

Summary: the purpose of this study is to gather additional evidence of the safety and immunogenicity of 1 dose of fluarix tetra (0.5 milliliter \[ml\]) (northern hemisphere (nh)2023-2024) in individuals aged 65 years and above to fulfill a post-approval condition imposed by the indian regulatory authorities (cdsco) for this age group in india.


Eligibility criteria:
inclusion criteria: * male or female participants aged \>= 65 years of age * participants and/or legally acceptable representative (s) (lar) who in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits * written or witnessed/thumb printed informed consent obtained from the participant and/or participant's lar(s) after the study has been explained according to the local authority requirements and prior to performance of any study-specific procedure exclusion criteria: * history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine. * receipt of licensed vaccine, immune sera and/or any blood products, or an investigational trial agent within previous 30 days or planned during their participation in the trial. * receipt of any flu vaccine within 6 months before trial start or any other vaccine within 30 days before the trial. * receipt of any dose of a coronavirus disease 2019 (covid-19) vaccine within 15 days of trial start. * history of guillain-barré syndrome. * altered immune status or chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within six months prior to administration of trial vaccine. * history of acute infectious disease or acute respiratory illness needing antibiotics or antivirals in the previous 7 days, based on investigator's judgement. * if a participant candidate has fever, the trial vaccination should be postponed to when the fever has resolved for at least 2 days (temporary exclusion criterion). fever is defined as temperature \>=38.0 degree celsius (°c) (100.4 degrees fahrenheit \[°f\]) by any route. the preferred location for measuring temperature will be oral route. * acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination, or laboratory screening tests. * any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the trial.
cohort to augment the understanding of sarcoma survivorship across the lifespan

Conditions: Sarcoma

Summary: this study evaluates the impact that a sarcoma diagnosis and treatment have had on patients over time.

* to evaluate the incidence and prevalence and the impact of disease, treatment, sociodemographic and lifestyle contributors on adverse oncologic outcomes (lack of response, recurrence) and non- oncologic outcomes (physical and psychosocial function, financial toxicity, short and long-term organ toxicity) and mortality in the cohort. * to evaluate the role of drug metabolism and dna repair genes via functional polymorphisms, known toxicity associated polymorphisms and genetically predicted gene expression levels, as well as polygenic risk scores, on treatment efficacy, cancer therapy-induced normal tissue toxicity and mortality. * to identify genomic drivers of sarcoma and to use this information to develop personalized liquid biopsy assays for monitoring treatment response, recurrence, and minimal residual disease (mrd) and mortality. * evaluate family functioning, psychosocial wellbeing, and financial toxicity. outline: this is an observational study. patients monitor physical activity, sedentary behavior, heart rate and sleep wearing a fitbit device, undergo blood urine, stool and/or saliva sample collection, complete surveys and have medical records reviewed throughout study.

Eligibility criteria:
patients at any age with a history of sarcoma, with or without evidence of a persistent disease • for pediatric patients * parent/primary caregiver of patient * sibling of patient aged 8 years or older