Kornimate/medical-research-clean huggingface dataset:
the effect of probiotic and zinc supplementation on the common cold

Conditions: Common Cold

Summary: the purpose with this study is to investigate the preventative effect of a supplement containing a combination of probiotic bacteria and fungi as well as zinc on the common cold. the hypothesis is that it will shorten the duration, alleviate the severity of symptoms or even decrease the number of infectons during the intervention period. this study is a randomzed placebo controlled human study were healthy adults will consume the supplement for three months.


Eligibility criteria:
inclusion criteria: * healthy adults exclusion criteria: * diagnosed gastrointestinal disorders * autoimmune diseases or immuno compromized * antibiotic treatment in the last month
immunogenicity and safety of pneumococcal vaccination in patients treated with immune checkpoint inhibitors

Conditions: Melanoma; Non Small Cell Lung Cancer

Summary: this is a prospective observational study of vaccine efficacy and safety in adult patients with malignancies (melanoma/hodgkin's lymphoma/non-small cell lung cancer). the primary objective is to compare serotype specific immunoglobulin g (igg) antibody titres before and after pneumococcal vaccination in patients receiving immune checkpoint inhibitors (ici). as an explorative objective, serotype specific igg antibodies measured by elisa and those measured by opsonophagocytosis assay (opa) after pneumococcal vaccination in patients receiving ici will be correlated. in addition, the incidence of immune related adverse events (irae) in patients vaccinated during ici treatment will be determined.

physicians will be informed by mail and pocket cards with all necessary information about the study, in particular eligibility criteria. patients currently receiving immune checkpoint inhibitors will be approached by their treating physicians in case of an already scheduled vaccination against s. pneumonia. if a patient agrees to participate in the study and to sign an informed consent form, basic data on demographics, underlying disease, comorbidities, and irae will be obtained from the electronic health record and entered into the ecrf. pneumococcal antibody titers will be drawn at baseline and after 30 days. we will actively follow-up on study patients for four months after enrolment and screen health records of the enrolled patients after four months to record occurrence of irae. a blood sample (9 ml) will be drawn before vaccination. vaccination will either be performed by the treating physician or by a general practitioner. after 30 days, a second blood sample will be taken during an already planned visit at the (outpatient) clinic. titer assessment will be performed along stiko recommendations for immunocompromised patients. all samples for elisa and opa titer determination will be stored frozen at department i for internal medicine and titers will be analyzed in batch at the end of this study. all therapies and diagnostics including vaccinations will be administered solely as part of clinical routine and as recommended by appropriate guidelines (rki stiko recommendations).

Eligibility criteria:
inclusion criteria: * signed informed consent form * age ≥18 years * receiving pneumococcal vaccination for the first time along stiko criteria * therapy with a pd-1, anti-pd-ligand 1 (pd-l1) agentfor melanoma, nsclc or other malignancy exclusion criteria: * patients unwilling/ineligible for vaccination under current stiko recommendations * previous vaccination with any licensed or experimental pneumococcal vaccine * concurrent treatment with anti-ctla-4 agent

Keywords: immune checkpoint inhibitor pneumococcal vaccination
study to assess adverse events and how abbv-932 oral capsules moves through the body of healthy adult participants

Conditions: Generalized Anxiety Disorder (GAD); Healthy Participants

Summary: the main objective of this study is to assess pharmacokinetics, safety, and tolerability of abbv-932 in healthy adult participants.


Eligibility criteria:
inclusion criteria: * parts 1 and 2: healthy individuals with body-mass index (bmi) \>= 18.0 to \<= 32.0 kg/m2, rounded to the tenths decimal. * part 3: healthy japanese, han chinese individuals with bmi \>= 18.0 to \<= 30.0 kg/m2, rounded to the tenths decimal. * condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile, neurological examination, and a 12-lead ecg. exclusion criteria: - history of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.

Keywords: generalized anxiety disorder (gad) abbv-932
effect of glucocorticoids on inflammation and bone metabolism in patients with glomerular disease

Conditions: Glomerular Disease

Summary: the aim of the study is to assess the influence of high doses of intravenous corticosteroids on plasma inflammation and bone markers in patients with primary glomerular disease. the study would include 40 patients with chronic kidney disease. the main inclusion criterion is clinical and histopathological diagnosis of primary glomerular disease and urine protein excretion \>2.0 g/24h. the exclusion criteria include secondary glomerular disease, acute kidney injury, acute or chronic inflammation, history of non-compliance.

glucocorticoids are one of the most widely used classes of drugs to treat inflammatory and autoimmune diseases. they increase formation of osteoclasts and enhance bone resorption thereby increasing risk of bone fractures and osteoporosis. sirtuin-1(sirt-1) belongs to family of proteins involved in protection against inflammation and oxidative stress. a role of sirt-1 in regulation of bone metabolism during high-dose steroid therapy is unknown. the study protocol was approved by the local bioethics committee and the study is conducted according to the declaration of helsinki. adult patients with the previous diagnosed primary glomerular disease based on both clinical and renal biopsy findings are included. plasma concentration of sirt-1, interleukin-6 (il-6), fibroblast growth factor 23 (fgf-23), sclerostin, calcium, phosphate, parathormone (pth) and urine excretion of total protein, albumin, creatinine, calcium and phosphate are measured at baseline. then the patients receive three intravenous pulses of methylprednisolone of 500 mg followed by oral prednisone 0.8-1.0 mg/kg/24h. the same measurements are repeated 4, 7 and 30 days after starting the steroid treatment.

Eligibility criteria:
inclusion criteria: * previous diagnosed primary glomerular disease based on both clinical and renal biopsy findings * an estimated glomerular filtration rate ≥15 ml/min/1.73m2 * proteinuria ≥2.0 g/24h exclusion criteria: * secondary glomerular disease * acute kidney injury * acute or chronic inflammation * malignancy * uncontrolled hypertension with systolic blood pressure higher than 160 mmhg * symptomatic hypotension * advanced heart failure * history of non-compliance, dementia or depression

Keywords: glucocorticoids primary glomerular disease sirtuin-1 sclerostin
national approach to standardize and improve mechanical ventilation

Conditions: Mechanical Ventilation Complication

Summary: this is a pre-post implementation cohort study. this is a data driven quality improvement project which aims to improve the care of mechanically ventilated patients through the implementation of a bundle of evidence based practices, with a goal of reducing ventilator associated events and mortality.

nasam is a national collaborative quality improvement project in saudi arabia which aims to: 1. reduce the rate of ventilator-associated events 2. improve the compliance with nasam bundle elements 3. reduce the mortality of mechanically ventilated patients the plan of this quality improvement project is to extend the implementation to a total of 100 icus in collaboration with multiple health systems across the country. a significant component of this project includes measuring the safety culture of icus.

Eligibility criteria:
inclusion criteria: * all adult patients admitted to intensive care units exclusion criteria: * age less than 14 years old

Keywords: ventilator-associated pneumonia mechanical ventilation ventilator-associated events intensive care unit quality improvement project
effectiveness of ergonomic training and exercise in automotive factory workers with nonspecific chronic low back pain

Conditions: Work-related Illness

Summary: this study compares the effectiveness of ergonomic training and exercise in automotive factory workers with chronic low back pain of unknown cause.

the study was planned as a randomized controlled study. workers between the ages of 18-60 who have back pain and work in an automotive factory in galway, ireland will be included in the study. participants will be divided into two groups. the factory workers included in the study will be divided into a study group and a control group using a simple random method. randomization will be done using the sealed envelope method. the study group will be given stretching and strengthening exercises along with ergonomics training. the control group will be given only ergonomics training. the exercises they will do and the ergonomics training will be explained to the participants individually and supported with a brochure. the participants will be asked to do the given exercises 3 days a week and continue for 12 weeks. the given exercises will be followed up with an exercise follow-up chart. in order to collect data on the sociodemographic characteristics of the participants, a personal information form will be prepared by the researcher and the participants will be asked to fill it out. in order to collect data from the participants; visual analog scale will be used to collect information about pain, international physical activity questionnaire to collect information about physical activity levels, pittsburgh sleep quality questionnaire to determine sleep quality, oswestry low back pain scale for functionality assessment, manual muscle testing to determine muscle strength. these questionnaires will be repeated before starting the study and at the end of the study. the data to be obtained will be evaluated using spss 24 package program.

Eligibility criteria:
inclusion criteria: * being between 18-60 years old * having worked in the same factory for at least 2 years * working full time * having complained of back pain for at least 3 months * visual analog scale\>4, pain 4 and above on visual analog scale exclusion criteria * being under 18 years old or over 60 years old * having worked for less than 2 years * working part time * having complained of back pain for less than 3 months * visual analog scale presence of psychological problems * using sleeping pills * having undergone surgical intervention in the last 6 months
comparative effectiveness of online 8-session cbt vs. 1-session empowered relief for chronic pain - the progress study

Conditions: Pain, Chronic; Lupus; Pelvic Pain

Summary: the purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness of: (1) 8-week cognitive behavioral therapy for chronic pain (pain-cbt; sixteen hours total treatment time); and (2) a 1-session pain relief skills intervention for chronic pain (empowered relief; two hours total treatment time).

the purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness: (1) 8-session cognitive behavioral therapy for chronic pain (pain-cbt); and (2) a 1-session pain relief skills intervention for chronic pain (empowered relief). the investigators aim to understand for patients which treatment works best. online evidence-based behavioral treatment for pain will greatly expand access to patients across the u.s. living with diverse chronic pain conditions. results from this study will fill several critical gaps in evidence that are preventing patients and physicians from making informed decisions about their pain care. this study will provide a low-cost, relatively low-risk, widely available and feasible protocol that directly addresses the needs of millions of community-based outpatients and their physicians.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age or older of either sex (and all genders). 2. chronic pain (pain that occurs on at least half of the days of 3 months or more). 3. past-month average pain intensity score of at least 3/10. 4. ability to adhere to and complete study protocols. exclusion criteria: 1. inability to provide informed consent. 2. cognitive impairment, non-english speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study including group treatment. 3. active suicidality at screening. 4. study staff may exclude individuals with a known history of disruptive behavior to minimize contamination of the learning environment for an entire treatment cohort. 5. receipt of either study treatment in the past 3 months.

Keywords: young adult lupus pelvic pain behavioral health
mesenchymal stem cell augmentation in patients undergoing arthroscopic rotator cuff repair

Conditions: Full Thickness Rotator Cuff Tear

Summary: the primary objective of this study is to compare the clinical outcomes of arthroscopic rotator cuff repair with and without augmentation of mesenchymal stem cells (mscs). mesenchymal stem cells promote tissue regeneration by differentiating into adult cell lines and by supplying growth factors to their implanted environment. they have been shown to be effective in improving both overall healing and tendon integrity in rotator cuff repair. this study will follow 100 patients in the united states and track their clinical outcomes for at least one year post-operatively.

rotator cuff repair is one of the most commonly performed arthroscopic procedures in the united states, but re-tear remains a common long-term complication. this can lead to pain, decreased shoulder function, and the need for corrective surgery. mesenchymal stem cells have been shown to improve healing rates in arthroscopic rotator cuff repair, primarily due to their retained ability to differentiate into several different adult cell lines, such as tenocytes, chondrocytes, and osteoblasts. mscs further enhance the healing process by releasing growth factors into the local environment to promote tissue regeneration. while msc augmentation of arthroscopic rotator cuff repair has led to higher rates of healing and improved tendon integrity, there remains a paucity of data surrounding clinical improvement after the procedure. outcomes such as post-operative strength, range of motion, and shoulder function have yet to be compared with standard rotator cuff repair. the incidence of post-operative persistent structural defects in the tendon after msc augmentation must also be further elucidated.

Eligibility criteria:
inclusion criteria: * patient is determined to have a full thickness rotator cuff tear (1-3 cm) or partial tear converted to a full-thickness tear-on the pre-operative mri scan or found arthroscopically-and is scheduled to undergo surgical repair * written informed consent is obtained exclusion criteria: * revision surgery * irreparable tear or partial repair * any patient lacking decisional capability * subscapularis involvement

Keywords: mesenchymal stem cells
adhesion to therapeutic strategies for outpatients with heart failure - adhesion-hf

Conditions: Heart Failure

Summary: the purpose of this study is to verify the impact of the educational intervention in the adhesion to therapeutic strategies for patients with heart failure.

1. characterize the socio-demographic and clinical aspects of heart failure patients; 2. awareness before and after nursing consultation, in relation to diet for heart failure, liquid and weight, general heart failure information, medication, physical activity, measures to improve disease control, signs of decompensated heart failure; 3. adhesion of patients before and after nursing consultation, related to medication, liquid and weight, use of alcohol and importance of returning for consultation and exams. 4. evaluated the impact of educational intervention at the levels of nt-probnp, urea, creatinine, sodium, potassium, before and after nursing consultation; 5. the 6 minute walk test performance before and after nursing consultation; 6. the distance covered and time of the 6 minute walk test, until fatigue in heart failure patients before and after nursing consultation;

Eligibility criteria:
inclusion criteria: * during the first phase of the study all the heart failure patients with ventricular ejection fraction of up to 49% shall be included (confirmed through ecott performed during the past year). all patients inserted had systolic heart failure and were scheduled and which agreed to take part of the research, signing a term of informed consent. exclusion criteria: * individuals with cognitive deficit, first outpatient medical consultation, suffered ami (acute myocardial infarction) within the last 3 months or a stroke, post-operative of cardiac surgery, patients with chronic obstructive pulmonary disease (copd), orthopedic problems, patients over the age of 80 and those that do not accept to participate of the research.

Keywords: adhesion, knowledge, nursing
combined determination of strem-1, pct and cd64 in diagnosing sepsis

Conditions: Critically Ill Patients

Summary: the purpose of this study is to determine wether the combined measurement of the soluble form of trem-1, pct and the determination of neutrophils cd64 expression could diagnose sepsis in critically ill patients.


Eligibility criteria:
inclusion criteria: * all consecutive patients admitted into the icu exclusion criteria: * absence of social protection

Keywords: sepsis diagnosis biomarker
development of imaging, clinical and biochemical bio-markers for parkinson's disease

Conditions: Parkinson's Disease; Parkinsonian Syndrome

Summary: we propose to build on preliminary data evaluating non-dopaminergic/non-motor clinical biomarkers to more fully assess these markers at the threshold of parkinson disease (pd). development of reliable biomarkers for both dopaminergic and non-dopaminergic manifestations of parkinson disease (pd) and related disorders may dramatically accelerate research on pd etiology, pathophysiology, and therapeutics. biomarkers are broadly defined as characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. specific biomarkers may be useful at the onset of neurodegeneration, the onset of disease, and/or to mark disease progression.

two hundred patients who have undergone neurological evaluation by their general community neurologist and have a questionable diagnosis of pd will be recruited to participate in this study. subjects will be referred by the neurologists to the institute for neurodegenerative disorders (ind) in new haven, ct. all subjects will be clinically evaluated at ind by a two movement disorders experts. at the baseline visit all subjects will also undergo \[123i\]ß-cit spect anam, voice acoustics, olfactory, spiral and biochemical testing. each movement disorders expert will make an initial clinical diagnosis at baseline and again within three months follow-up. at the three month visit one movement disorder expert will be provided the dat imaging data and will review that data with the subjects and referral physician. the other movement disorders physician will remain blind to the imaging and all other biomarker data. the blinded movement disorders expert will provide a final clinical diagnosis at the 12 month follow-up visit, which will represent the 'gold standard' diagnosis in this study. statistical analysis to determine the sensitivity and specificity of anam, voice acoustics, olfactory, spiral and biochemical testing compared to \[123i\]ß-cit spect, and the gold standard clinical diagnosis will be completed. all subjects with dat deficit and 10% of those without dat deficit will be asked to return for repeat evaluation at 24 months.

Eligibility criteria:
inclusion criteria: * older than 21 * any parkinsonian symptoms * referral by community neurologist * parkinsonian symptoms for less than 2 years duration. * willingness to follow the study plan. exclusion criteria: * pregnancy * significant medical disease including abnormalities on screening biochemical or hematological labs or abnormal electrocardiogram (ecg - tracing of the electrical activity of the heart)

Keywords: parkinson
sexual function in high-risk pregnant women

Conditions: High Risk Pregnancy; Sexual Dysfunction; Anxiety; Female Sexual Function

Summary: our aim with this study is to evaluate the sexual functions of pregnant women whose pregnancies are defined as high-risk pregnancies and whose pregnancies are followed by perinatology specialists.


Eligibility criteria:
inclusion criteria: - pregnant women over 18 years old, -pregnant women 39 years old and under, -pregnant women in their 3rd trimester. exclusion criteria: - pregnant women under 18 years old, -pregnant women over 40 years old, -pregnant women in their 1st or 2nd trimester.

Keywords: high-risk pregnancy perinatology sexual dysfunction female sexual function fsfi
effect of vitamin d3 supplementation in pregnancy on risk of pre-eclampsia

Conditions: Vitamin D Deficiency; Pre-Eclampsia

Summary: vitamin d deficient pregnant ladies were selected and randomized into 2 groups for routine daily dose of multivitamin (400iu vitamin d3) versus maximum safest treatment daily dose (4000iu vitamin d3). participants were assessed and compared for number of pre-eclampsia cases.

vitamin d3 has key role in decidualization and implantation of placenta.vitamin d deficiency is thought to have positive association with pre-eclampsia.vitamin d deficiency is highly prevalent in some parts of the world and it is not universally screened antenatally. pre-eclampsia is a known multifactorial pregnancy disorder with significant maternal and perinatal morbidity and mortality. vitamin d3 has a down-regulating effect on inflammatory pathways and reducing endothelial cell damage. investigators want to assess in vitamin d deficient group whether treatment reduces the risk of pre-eclampsia.

Eligibility criteria:
inclusion criteria: * confirmed singleton pregnancy of less than 13 completed weeks of gestation at the time of consent. * planned to receive antenatal care in king fahad medical city antenatal clinic. * the ability to provide written informed consent at the first visit. * low risk pregnancy; and serum vitamin d3 levels less than \< 25nmol/l. exclusion criteria: * mothers with pregnancy with abnormal foetus. * previous history of hypertension, pre-eclampsia, recurrent miscarriages. * chronic kidney disease, chronic liver disease, and malignancy.

Keywords: maternal vitamin d deficiency insufficiency pregnancy pre-eclampsia iugr