Kornimate/medical-research-clean huggingface dataset:
sss and the impact of portion size on daily energy intake

Conditions: Diet, Healthy; Eating Behavior; Obesity

Summary: reducing food portion size is a potential strategy to reduce energy intake. however, it remains unclear who is most susceptible to the portion size effect (pse). there are just two studies which have examined the pse in the context of socioeconomic position (sep), with mixed findings. in an online trial the pse on intended consumption of unhealthy snacks was 18-24% larger for participants of lower sep compared to participants of higher sep. however, in a recent laboratory study which examined the pse on total daily energy intake, participants of lower sep were no more susceptible to the influence of portion size on eating behaviour than participants of higher sep. further research is required to elucidate these divergent findings. there is also an absence of evidence examining the moderating role of subjective social status (sss) - an individual's perceived standing in society - on the pse. given evidence that the subjective experience of social class may be associated with health outcomes, the present study examines whether reductions to the portion size reduces daily energy intake, and whether and how sss (higher vs lower) moderates the pse. in a crossover experiment, participants will be served all meals in the lab on two separate days, with the portion size of main components at breakfast, lunch and dinner manipulated (i.e. smaller on one day vs larger on the other day). all other foods offered are identical. food intake from the portion-manipulated breakfast, lunch and dinner, as well as all other meal components (non-portion-manipulated sides, dessert, seconds, snacks, etc.) will be measured, to assess total daily energy intake (kcal).

see study protocol attached.

Eligibility criteria:
inclusion criteria: * female * uk (united kingdom) residents, able to visit laboratory in liverpool * aged 18 or over * fluent in english * willing to consume the test foods * self report willingness to eat test foods * bmi between 18.5 - 32.5kg2 exclusion criteria: * participation in our previous study * food allergies, intolerances or specific dietary requirements (except vegetarian) * taking medication which affects appetite * currently pregnant * history of eating disorders * currently on a diet to lose weight

Keywords: portion size socio-economic position eating behaviour
temokids study : a phase i pediatric study for kimozo, oral suspension of temozolomide

Conditions: Pediatric Cancer

Summary: non-randomized, international, multi-centre, open-label, single arm study to determine the pharmacokinetic (pk) parameters of a single dose of an oral suspension of temozolomide (kimozo) in the pediatric population aged 1 year and over.

the temokids study is an international open-label, non-randomized, prospective, single-arm phase 1 study to determine the pharmacokinetic (pk) parameters of a single dose of an oral suspension of temozolomide (kimozo) in the pediatric population aged 1 year and over. patients will be subject to at least one 21 or 28-day treatment cycle involving administration of an oral suspension of temozolomide (kimozo) for five consecutive days followed by 16 or 23-days resting period, with determination of the pk parameters on the first treatment day. five (5) additional cycles will be allowed under compassionate use regimen. the compassionate use period could be extended at the discretion of the investigator and in agreement with the sponsor. safety and activity data will be collected during the compassionate follow-up period. the study will be held in multiple sites spread across europe.

Eligibility criteria:
inclusion criteria: * pediatric patients in need of temozolomide (all indications with 5-day treatment per 21- or 28-day cycle). * male and female patients aged 1 to less than 18 years * patients who have signed the informed consent or for which one, both parents or legal guardian (depending on local legislation) have signed the informed consent. * patients having records of coverage by a health insurance * life expectancy ≥ 3 months * adequate haematological function: * haemoglobin ≥ 80 g/l (transfusion support authorized) * neutrophil count ≥ 1.0 x 10e9 cells/l * platelet count ≥ 100 x 10e9 cells/l (without transfusion support) * in case of bone marrow involvement: neutrophils ≥ 0.5 x 10e9 cells/l and platelets ≥75 x 10e9 cells/l * adequate renal function: * creatine clearance ≥ 60 ml/min.1.73m² according to the schwartz formula \[1\] or its modified form \[2\] * adequate hepatic function: * bilirubin ≤1.5 x uln * ast and alt ≤ 2.5 x uln (ast, alt 5xuln in case of liver metastases) * lansky score ≥ 70% exclusion criteria: * patients who are co-administrated at day one with sodium valproate as it decreases the clearance of temozolomide * patients with (naso)gastric tube administration of temozolomide during first cycle of treatment. * patients already enrolled in studies investigating temozolomide or other investigational new drugs. * a post-menarche female with a positive blood/urine pregnancy test at inclusion. * known contraindication or hypersensitivity to temozolomide or any chemically close substance

Keywords: neuroblastoma other pediatric cancers requiring temozolomide
safety and efficacy of changing to duotrav from prior therapy

Conditions: Glaucoma

Summary: the purpose of this study to assess the safety and efficacy of changing to duotrav® from prior bimatoprost 0.03%/timolol 0.5% (used concomitantly or in a fixed combination) pharmacotherapy in uncontrolled patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes. * must have an iop of between 19 to 35 millimeters mercury (mmhg) (at any time of the day) in at least one eye (which would be designated as the study eye). * must be willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study. * women who are pregnant or lactating. * other protocol-defined inclusion criteria may apply. exclusion criteria: * known medical history of allergy, hypersensitivity or poor tolerance to any component of duotrav® that is deemed clinically significant in the opinion of the principal investigator. * corneal dystrophies in either eye. * risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment. * bronchial asthma or a history of bronchial asthma, bronchial hyper-reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker. * history of severe allergic rhinitis. * other protocol-defined exclusion criteria may apply.
the epidemic status and development trend of hepatitis c virus infection in pregnant women in xi'an

Conditions: HCV Infection; HCV Elimination

Summary: the objectives of this study are to improve hcv linkage-to-care in chinese women and provide theoretical basis for the scientific formulation of hcv prevention and control strategies for pregnant women. to understand the epidemiological changes and status of hepatitis c virus (hcv) infection in pregnant women in shaanxi province in recent 10 years, and to analyze the main influencing factors of hepatitis c infection in pregnant women.


Eligibility criteria:
inclusion criteria: 1. pregnant women or parturient women confirmed by blood hcg test. 2. patients aged 18 years old and above. 3. patients with hcv antibody seropositive or hcv rna positive from 2014-2023. exclusion criteria: 1. patients without valid telephone numbers. 2. duplicate records: for duplicate records of the same pregnant woman, only one record should be kept.

Keywords: hepatitis c hcv elimination women of childbearing age
safety and efficacy of repeated doses of pmi-150 (intranasal ketamine) in acute post-operative pain following orthopedic surgery

Conditions: Pain, Postoperative

Summary: the purpose of this research study is to evaluate the safety and analgesic efficacy of pmi-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery.

patients will be randomly assigned to pmi-150 (intranasal ketamine) or placebo and will receive repeated doses and be assessed for safety and efficacy.

Eligibility criteria:
inclusion criteria: * patient is scheduled for elective orthopedic surgery or procedure exclusion criteria: * patient has received an investigational drug or participated in a clinical trial within 30 days or 5 half-lives (whichever is longer) of entering this study

Keywords: orthopedic ketamine pain
effects of exercise training on left ventricular function in type 2 diabetic patients post coronary artery bypass graft

Conditions: Diabetes Mellitus, Non-Insulin-Dependent; Coronary Arteriosclerosis; Post Coronary Artery Bypass Grafting

Summary: the purpose of this study is to investigate the changes of cardiorespiratory fitness and left ventricular function in type 2 diabetes after uncomplicated coronary artery bypass graft (cabg) surgery. we hypothesize that exercise capacity, left ventricular diastolic function, and biochemical data improves after 12-wk exercise training in patients with type 2 diabetes underwent cabg.

patients with type 2 diabetes mellitus have higher incidence of coronary artery disease or left ventricular dysfunction, particularly diastolic dysfunction. coronary artery bypass surgery is known to decrease the mortality rate in diabetes. further exercise training can improve their cardiorespiratory fitness and the control of risk factors in these patients. however, the extent of improvement and the mechanism, especially the changes in left ventricular function, in diabetes after exercise training have not been fully explored. subjects will be assigned to the intervention or control group by randomization. subjects in the intervention group will receive 60% vo2 max moderate aerobic exercise training, twice per week under supervision and three times per week at home, for 12 weeks. all subjects receive left ventricular function test by echocardiography and impedance cardiography, graded maximal exercise test, and biochemical analyses of sugar and lipid before and after 12 weeks. their dietary intake and physical activity will be inquired every 4 weeks by questionnaires.

Eligibility criteria:
inclusion criteria: * well-controlled diabetes * no history of myocardial infarction * stable post cabg for at least 3 months exclusion criteria: * heart failure * valvular disease * abnormal kidney or liver function * cerebrovascular disease * primary pulmonary disease * other systemic or acute illness that may impede the testing or training
tokophobia ; our clinical experience

Conditions: Tocophobia; Pregnancy Complications

Summary: fear of childbirth, or what has historically been called tokophobia, is often described as a severe fear of birth and pathological fear of childbirth. the reasons for fear of childbirth are stated as biological reasons, psychological reasons and lack of social support. however, it is still not possible to clearly explain the reasons for the fear of childbirth in pregnant women and the risk factors affecting them. the reasons for the fear of childbirth and the affecting factors have not been fully explained.

the aim of this study is to examine the relationship between fear of childbirth and anxiety sensitivity in pregnant women, and whether the mode of delivery changes depending on this fear and these data. the aim of the authors is to reveal the frequency and causes of tokophobia in pregnant women followed in their clinics and to show the birth patterns of these patients.

Eligibility criteria:
inclusion criteria: * 3rd trimester pregnant women who are followed up in our clinic and will give birth in our clinic. * pregnant women between the ages of 18 and 40 exclusion criteria: * those in the risky pregnancy category (preeclampsia, gdm, iugr... etc.) * known to have fetal anomaly during follow-ups * those with chronic disease * those with sexually transmitted diseases * those with a history of cesarean section

Keywords: vaginal birth cesarean delivery fear of childbirth
efficacy of disci/rhus toxicodendron comp.®, in patients with chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the aim of the study is to evaluate the efficacy of disci/rhus toxicodendron. comp.® in patients with chronic low back pain compared to waiting list group, or placebo.

chronic low back pain is a significant health problem in industrialized countries. use of complementary medicine is increasing in patients with low back pain. until now there is no evidence for the efficacy of disci/rhus toxicodendron. comp.® in patients with chronic low back pain.

Eligibility criteria:
inclusion criteria: * male and female patients, 30 to 75 years * willingness of following the study protocol * clinical diagnosis of chronic low back pain * low back pain since at least 3 months * average pain intensity of at least 40 mm on vas (0-100 mm) in the last 7 days * in the last 4 weeks only oral nsad and muscle relaxation treatment * effective oral contraception in woman * informed consent exclusion criteria: * previous treatment with disci comp. * treatment with other than nsaid * routine use of pain drugs for other diseases * protrusio or prolapse of one or more intervertebral discs with neurological symptoms * previous spine surgery * (suspicious) infectious spondylopathy * low back pain because of malignant or infectious disease * other causes of back pain symptoms (e.g. m. bechterev, m. reiter) * congenital deformity of spine (without minor lordosis or kyphosis or scoliosis * (suspicious) osteoporosis with compression fracture * (suspicious) spinal stenosis * spondylolysis or spondylolisthesis * physiotherapy in the last four weeks or planed during trial * begin of a new treatment for low back pain * complementary treatment in the last four weeks or planed during trial * patients who are not able to cooperate in a sufficient way * patients with alcohol or substance abuse * participation in another clinical trial * severe chronical or acute disease which does not allow study participation * patients with bleeding disorders or oral anticoagulation treatment * pregnancy and breast feeding * patients with application for pension * patients involved in planning or coordination of the study * hypersensitivity against drug components

Keywords: low back pain complementary therapies
intra-nasal mechanical stimulation (inmest) as a treatment method for the relief of symptoms of dry eye

Conditions: Dry Eye; Dry Eye Syndromes

Summary: the purpose of the study is to investigate the degree of symptom relief in people with signs or symptoms of dry eyes after self-treatment at home with the walther system delivering inmest (intranasal mechanical stimulation). a total of 110 subjects are planned to be enrolled and randomized to either use an active device or a sham device. both groups will also receive standard treatment in mainstream healthcare for symptoms of dry eye. the subject self-administer treatments at home, three times a week for six weeks, with a follow-up period of three months after end of treatment.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. the study subject reports having understood and signed the informed consent form (icf) and is willing to comply with all investigation visits and assessments 3. history of dry eye in both or one eye, supported by a previous clinical diagnosis or have self-reported history of complaints for at least 4 months prior to enrolment 4. women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study 5. osdi score \> 15 6. non-invasive tear break-up time (nibut) ≤ 10 seconds 7. anticipated compliance with prescribed treatment and follow-up exclusion criteria: 1. recently (3 months prior enrolment) undergone nasal or sinus surgery 2. women who are pregnant as determined by urine test at inclusion and prior to study start (applies to sites in denmark only) 3. ongoing acute upper respiratory tract infection, per the investigator's judgement 4. bleph-ex treated within 3 months prior to enrolment 5. the study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation 6. the study subject is considered by the investigator to be unsuitable to participate in the investigation for any other reason 7. any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation 8. previous (within 30 days prior to enrolment/randomization) and concurrent treatment during the treatment phase with another investigational drug/s or device/s
the effect of nature-based exposure on the immune system and skin health of atopic dermatitis patients.

Conditions: Atopic Dermatitis

Summary: the purpose of the study is to explore the effect of nature-based exposure on immunological biomarkers and the condition and symptoms of atopic skin. our hypothesis is that regular exposure to nature-based, high biodiversity material on skin, strengthens the skin's protective barrier and has a positive effect on the immunological biomarkers associated with atopic dermatitis. further our hypothesis is that the difference between the groups (active and placebo) is noticeable during winter time when the disease is typically worse because of the cold weather. the study aim at scientific publication and is double-blinded and placebo-controlled. time of the intervention is 6-7 months: intervention starts before the finnish winter time and ends before the summer.


Eligibility criteria:
inclusion criteria: * a person aged 18-65, legally competent * meets hanifin \& rajka's criteria for atopic dermatitis in the initial interview and eczema has also appeared regularly in adulthood * the possibility to commit to the research exclusion criteria: * cancer or cancer treatments * medication that suppresses the immune system (excluding antihistamines) * systemic medicine intended for the treatment of atopic dermatitis (orally or as an injection, other than an antihistamine) or the use of clinical phototherapy in the last 6 months. * skin infection (such as a eczema that required antibiotic cream or a parasitic infection, e.g.scabies mite) during the last 6 months * atopic dermatitis that required hospitalization in the last 2 years * psoriasis or other skin disease affecting the study in addition to atopy * pregnancy or breastfeeding

Keywords: biodiversity intervention allergy atopy environmental microbes
incidence of delirium in hip fracture patients randomized to regular hypnotics vs placebo

Conditions: Hip Fracture; Delirium

Summary: to examine the influence of regular hypnotic therapy on the incidence of delirium after hip fracture surgery

delirium is prevalent after hip fracture surgery. delirium has been linked to postoperative sleep disturbances. zolpidem is a non-benzodiazepine hypnotic that preserves rem sleep. the present study investigates the incidence of delirium in hip fracture patients randomized to zolpidem treatment 5 mg vs placebo in the perioperative phase.

Eligibility criteria:
inclusion criteria: * primary hip fracture, no substance abuse, no regular opioid, corticosteroid or benzodiazepine therapy, hepatic insufficiency, myastenia gravis, allergies to drug components exclusion criteria: * severe respiratory insufficiency

Keywords: hip fracture delirium sleep disturbance hypnotic
study of vitespen (hsppc-96, oncophage ®) for immune response assessment in participants with resectable renal cell carcinoma at intermediate risk of recurrence

Conditions: Renal Cell Carcinoma

Summary: the primary objective of the study is to determine whether participants exhibit a measurable immune response after multiple administrations of hsppc-96 (heat shock protein-peptide complex 96), as assessed by enzyme linked immunosorbent spot (elispot) assay.

the study consists of two parts: part 1 with part 1a (assessment of immune variation) and part 1b (assay standardization), and part 2 (immune monitoring study). the study was terminated early with 12 participants enrolled only in part 1a and part 1b. part 2 of the study involved randomization after 8 doses of hsspc-96. after the 8 doses of hsspc-96 administered in part 2, the participants were to be randomized to the treatment extension arm or the placebo extension arm. there were no participants enrolled in part 2 since the study was terminated early. therefore, no randomization occurred in the conduct of this study and only a single arm was enrolled.

Eligibility criteria:
inclusion criteria: * confirmation of histological diagnosis of renal cell carcinoma (rcc) with evidence of \>= 25% clear cell carcinoma * american joint committee on cancer tumor/node/metastasis tumor stage at intermediate risk for recurrence * at least 8 doses of vaccine available from participant's tumor * life expectancy of at least 3 months * eastern cooperative oncology group performance status of 0 or 1 * cardiovascular disease status of new york heart association class less than 2 * adequate hematopoietic, renal and hepatic function * negative serology tests for human immunodeficiency virus (hiv), human t-cell lymphotrophic virus (htlv-1), hepatitis b surface antigen (hbsag), anti- hepatitis c virus antibodies (anti-hcv-ab) * females must have negative pregnancy test exclusion criteria: * evidence of metastatic or residual rcc * documented radiological enlarged lymph nodes * females who are pregnant or breastfeeding * use of any other investigational product from 4 weeks post-surgery * splenectomy performed during nephrectomy
melatonin use after primary total joint arthroplasty

Conditions: Osteo Arthritis Knee

Summary: the purpose of this study is to determine the effect of melatonin supplementation on patient sleep quality, length of stay, and opioid consumption following primary, unilateral, elective total hip or knee arthroplasty.

this will be a single-center randomized double blind placebo control clinical trial. in the cohort of patients undergoing primary elective total hip and the cohort of patients undergoing primary elective knee arthroplasty, participants are recruited from those who are willing to consent and participate in the study, and will be randomly 1:1 divided into intervention group and placebo group.

Eligibility criteria:
inclusion criteria: * patient are current candidates for elective primary total hip and total knee arthroplasty. * patients ≥18 years of age but ≤ 95 * patients have been medically cleared and scheduled for surgery exclusion criteria: * non-elective conversion arthroplasty * bilateral total joint arthroplasty * contraindications to use of melatonin (diabetes, calcium channel blocker use, depression) * conditions and medications likely to confound results due to impact on subjective and/or objective sleep quality (insomnia, drug/alcohol abuse, and use of benzodiazepines, and prescription sleep aids) * conditions likely to impair capacity to adhere to protocol (mental impairment, psychiatric disorders other than anxiety/depression)