Kornimate/medical-research-clean huggingface dataset:
the benefit of a deep cleansing gel in the management of mild to moderate truncal acne

Conditions: Acne

Summary: acne vulgaris is a chronic inflammatory disease, mainly of the face, but also of the trunk. acne may be caused by internal and external factors. only a very small amount of data exists concerning truncal acne. the condition affects about 9% of the population worldwide, with 50% of subjects with facial acne also presenting with truncal acne. until recently, clinicians frequently followed the same therapeutic approach as for facial acne, with treatment adherence remaining an issue. this study assessed assessed the benefit of a cleansing gel containing salicylic acid 2%, zinc gluconate 0.2% and lipo hydroxy acids (lha) 0.05%, used daily for 84 days in mild to moderate truncal acne.

for this single center, open label, non-randomized exploratory study, 51 subjects with mild to moderate truncal acne were recruited. the study received ethics committee approval. all subjects provided written informed consent. the investigator evaluated the number of inflammatory, non-inflammatory and total lesions at baseline, day 42 and 84. skin barrier function was appraised via the assessment of transepidermal water loss (tewl) using a tewameter® (courage + khazaka electronic gmbh, germany). safety was assessed by considering the evaluation of clinical signs and reporting of symptoms, and local adverse reactions. subjects were asked to gently massage the wet skin of the trunk with the product in the morning and evening for at least 30 seconds, and then thoroughly rinse with tempered water and pat dry.

Eligibility criteria:
inclusion criteria: * above 18 years * truncal acne exclusion criteria: - none

Keywords: truncal acne
study of safety, efficacy and pharmacokinetics of ct-707 in patients with alk-positive non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this is a phase i study of the alk/fak/pyk2 inhibitor ct-707 in patients with alk-positive non-small cell lung cancer. the purpose of the study is to determine the mtd/rp2d of ct-707 and evaluate whether ct-707 is safe and has beneficial effects in alk-positive advanced non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: patients must be diagnosed with alk-positive advanced nsclc. the tumor must be alk-positive as determined by alk rearrangement in ≥15% of cells (as measured by fish using the vysis break-apart alk probe) or by using the ventana alk ihc test. the analysis may be performed locally. eastern cooperative oncology group (ecog) performance status ≤ 2. measurable disease as per recist v1.1 availability of tumor sample: exclusion criteria: patients with symptomatic central nervous system (cns) metastases who are neurologically unstable or require increasing doses of steroids or local cns-directed therapy to control their cns disease impaired cardiac function or any clinically significant cardiac disease patients with abnormal laboratory values during screening and on day 1 of pre-dose impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of ct-707 patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease. other protocol-defined inclusion/exclusion criteria may apply.
phase ii pre-operative vitamin d supplementation to prevent post-thyroidectomy hypocalcemia

Conditions: Thyroid Nodules; Hypocalcemia

Summary: one of the major side effects of surgery to remove the thyroid gland is transient (lasting for a short time) low calcium levels in the blood, or "hypocalcemia." low calcium levels can cause symptoms such as numbness around the mouth, tingling or cramping in the hands and feet, severe muscle spasms, inability to breathe, or heart rhythm (heart beat) abnormalities. severe symptoms are life threatening, so it is important to start the management of these symptoms in the hospital. treating low calcium levels sometimes require patients to spend a few extra days in the hospital. the human body needs vitamin d to function and stay healthy. vitamin d helps the body get the calcium needed to make strong bones and teeth. the purpose of this study is to determine if taking vitamin d before surgery to remove the thyroid gland affects whether or not you may have low calcium levels after your surgery and to test the hypothesis that those who are given the vitamin d before surgery will have decreased hypocalcemia and a shortened hospital stay.


Eligibility criteria:
inclusion criteria: * patient referred for thyroidectomy * agreement to use contraception prior to and during the study exclusion criteria: * hypercalcemia (\>10.5mg/dl) * chronic kidney or parathyroid disease * cardiac or central nervous system disease * pregnant or breastfeeding women
total tumor mapping (ttm) for resectable pancreatic cancer

Conditions: Pancreatic Cancer; Resectable Pancreatic Cancer

Summary: at present there is no validated prognostic tool for patients with resectable pancreatic cancer (rpc) to determine how best to tailor individual therapy. this study is to see if tumor features in blood and imaging prior to surgery correspond with tumor heterogeneity in the specimen after surgery.

this study is to prospectively determine whether there is a predictive relationship in rpc between pre-operative radiomic imaging features and pathologic tumor heterogeneity, delineated by gene-expression-based rsi and histologic measures of hypoxia measured by glut-1 and ca-ix as well as the degree of pimonidazole staining.

Eligibility criteria:
inclusion criteria: * 18 years of age and older who have biopsy-proven resectable pancreatic cancer * participants must have a histological diagnosis of pancreatic head ductal adenocarcinoma at least ≥ 1 cm from ampula. * participants must be able to undergo all 3 imaging modalities. * participants' medical statuses must be considered appropriate for surgery and for general anesthesia. * female participants and female partners of male participants undergoing optional pet-ct or ct pancreatic protocol scan cannot be pregnant or nursing, as confirmed by serum pregnancy test if the patient is a woman of child-bearing potential. * all female participants of child-bearing potential must agree to use birth control, including oral, injectable, or mechanical contraception, abstinence, or vasectomy for 30 days following pimonidazole administration. * adequate kidney and liver function as assessed by laboratory studies. laboratory studies must be completed within 28 days prior to pimonidazole administration; * must be capable of providing informed consent and demonstrate a willingness to comply with all the study procedures and visits; * must be able to undergo mri scans without having a pacemaker or other indwelling metal, which would contraindicate the scan. * have an eastern cooperative oncology group (ecog) score of 0 to 2. exclusion criteria: * women who are pregnant or breastfeeding * participants who are contraindicated for mri or gadolinium contrast agents. * if the patient has an iodine contrast allergy, they must be able to take standard pre-medications so they can safely undergo a ct scan. * participants with a known active cancer with a prognosis that would contraindicate a curative intent pancreatic resection. * participants with depressed liver function, as assessed with a screening liver function test yielding serum alt or ast greater than the iuln or total bilirubin greater than 2 mg/dl. * presence of any other co-existing condition, which, in the judgment of the investigator, might increase the risk to the patient.
genetics and cardiovascular reactivity in young twins

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to evaluate the effects of genetic variants in all of the nine adrenergic receptor subtype genes, alone or in combination, on cardiovascular reactivity and other quantitative cardiovascular traits in a population of 1048 healthy young twins.

background: several studies have shown that cardiovascular reactivity (cvr) to acute laboratory stress is a stable and heritable trait and predictive of future blood pressure (bp) levels and essential hypertension (eh). the sympathetic nervous system (sns) has a major role in bp regulation and adrenergic receptor subtypes mediate bp responses to acute challenges. as such, our hypothesis is that individual differences in cvr are partly determined by variation in genes encoding for adrenergic receptors mediating the sympathoadrenal response to stress. there is increasing evidence that this cardiovascular response is regulated by multiple adrenoceptor subtypes with structural homology. to date, nine homologous adrenergic receptor subtypes have been described. only one study has found a gene-gene interaction upon cv disease incorporating two adrenergic receptor subtypes. genetic variants in all the nine adrenergic receptor subtypes have never before been investigated in a single study as this study will do. design narrative: the study will evaluate the effects of genetic variants in all of the nine adrenergic receptor subtype genes, alone or in combination, on cvr and other quantitative cardiovascular traits in a population of 1048 healthy youth. subjects are black and white twins that have already been comprehensively phenotyped as part of the georgia cardiovascular twin study (hl56622). racial differences in adrenoceptor gene effects will receive special attention, because such differences may offer a partial explanation for the higher prevalence of essential hypertension (eh) in blacks. primary measures are systolic bp at rest and in response to two behavioral stressors. secondary measures are diastolic bp, cardiac output and total peripheral resistance (tpr) at rest and in response to the stressors, left ventricular mass (lvm), endothelium dependent arterial dilation to reactive hyperemia (edad), arterial stiffness and 24-hour ambulatory bp. this data set will be expanded through collection of buccal cell dna from the parents of the twins, enabling performance of tdts (transmission disequilibrium tests) and haplotype reconstruction and analyses. this candidate gene study in a large group of black and white twins including tdt and haplotype analyses provides an innovative approach to help identify individuals at particular risk for the development of eh and improve options for primary prevention as well as individualized therapy of eh (pharmacogenetics).

Eligibility criteria:
no eligibility criteria
assessment of the impact of virtual reality on patient anxiety during dental avulsions under local anesthesia

Conditions: Tooth Avulsion; Anxiety

Summary: fear of the dentist is a very common phenomenon which delays consultations and brings negative consequences on oral and general health. virtual reality (vr) reduces children's pain and anxiety during dental care or oral surgery. the aim of this prospective, randomized and controlled study is to show the effectiveness of virtual reality to reduce anxiety in a sample of adults during tooth avulsions under local anesthesia. there is a group with virtual reality and a control group without virtual reality. patients complet the state trait anxiety inventory - state - (stai-ya) questionnaire and the visual analog anxiety scale (vas) just before and just after the surgery by transcribing the anxiety they feel during it. the main judgement criterion is the evolution of the stai-ya score before vs during the surgery. secondary criteria are the relevance of the chosen metric by comparing it to the vas, defining the factors influencing the evolution of the anxiety score, studying the side effects of vr and the wish to repeat the experience.

the virtual reality experience consisted of putting on a headset with music and a 3d helmet on the eyes that broadcast a landscape in motion (a walk). the inclusion took place in the university hospital of caen between november 2021 and may 2022. 119 patients were randomized into two groups, one with vr and another one without vr. at the end, 105 patients were analyzed. the main objective was to find a reduction in the stai-ya score of more than 8 points between before and during the intervention. this analysis was performed in both groups. during the initial consultation, questions were asked about the medical file and informed consent was sought. patients were then randomised to one of two groups. during the second consultation, a stai-ya questionnaire and a vas scale were completed, then the intervention was performed with or without virtual reality, depending on the group, and the stai-ya questionnaire and the vas scale were again completed by recalling the stress experienced during the surgery.

Eligibility criteria:
inclusion criteria: - adults (\> 18 years old) coming for at least two dental extractions under local anesthesia exclusion criteria: * patients suffering of motion sickness, * claustrophobia, * uncontrolled epilepsy, * visual impairment, * hearing disability, * non-french speakers, * pregnant women, * protected adults * people followed by a psychiatrist whether for depression, bipolarity, schizophrenia * the day of the intervention, patients who had consumed anxiolytics

Keywords: virtual reality oral surgery anxiety
comparison study of two splints used for treatment of acute temporomandibular pain.

Conditions: Myofascial Pain

Summary: the most commonly applied treatment against acute temporomandibular signs and symptoms is pharmacotherapy. the evidence on treatment efficacy of non-medication treatments (like splints) is very low. two very commonly used splints are the aqualizer® and the soft polyester splint. these are splints applied for a short period of time, until the treatment with a hard splint and/or physiotherapy begins. aim of this study is to compare the clinical short-time efficacy of these two splints for the treatment of acute temporomandibular pain and compare it to a control group receiving no therapy for that short time. the study hypothesis is that there is a difference in pain reduction between the three groups of patients (two intervention and one control group).


Eligibility criteria:
inclusion criteria: * adult patients, non-chronic orofacial pain exclusion criteria: * pregnancy, chronic orofacial pain, dental treatment need, dental pain, edentulous space larger than 5mm, more than three molars missing in the same quadrant, rheumatic disease, injury/operation in maxillofacial area.
assessing the repeatability of a psychological stress test

Conditions: Stress, Physiological; Stress, Psychological

Summary: to establish the efficacy and repeatability of a suitable psychological stress test. the mannheim multicomponent stress test (mmst) is a validated laboratory stress test that combines cognitive, emotional, acoustic and motivational stress components. despite the test increasing self-reported levels of stress, meaningful changes in saliva cortisol are typically observed in only half of all participants. in addition, the mmst is susceptible to habituation of the cortisol response upon repeated exposures, limiting its current usefulness for repeated measures. given the multicomponent nature of the mmst, there is potential for components of the test to be manipulated to overcome these limitations i.e., increase the magnitude of the saliva cortisol response and mitigate against habituation effects. in addition, a supplementary topic of interest is to what extent cortisol responses to acute laboratory stress tests, like the mmst, relate to the well described rise in morning cortisol \~30 minutes after awakening. this may be of clinical relevance given that blunted cortisol response upon awakening and in response to acute psychological stress tests have been associated with poor health outcomes. the primary objective of the current study is to investigate if the mmst elicits a meaningful increase in saliva cortisol. the secondary objective is to investigate the efficacy of mitigation strategies to overcome habituation to the mmst. a supplementary objective is to to investigate the relationship between the saliva cortisol response upon awakening and the saliva cortisol response to the mmst.


Eligibility criteria:
inclusion criteria: participants who... * have read and signed the study informed consent * are healthy, recreationally active men and women aged 18-35 years * test negative for coronavirus (covid-19) * are willing to provide saliva samples throughout and complete the mmst through the duration of the study * are using monophasic birth control (women only) exclusion criteria: participants who... * have a recent history or are a current smoker * are currently taking prescription/over-the-counter medication * consume ≥ 91 units of alcohol per month * have a clinically diagnosed history of cardiovascular and/or metabolic disease including diabetes and abnormal blood pressure * are pregnant * have a recent or ongoing viral or bacterial illness in past 4 weeks * test positive for coronavirus (covid-19) * have a clinically diagnosed psychiatric disorder * have a clinically diagnosed sleeping disorder * have a clinically diagnosed gambling addiction * bmi ≥ 30 kg/m2 - calculated in the online health screening questionnaire * report unusually high levels of recent or ongoing life stress over the last month; as assessed by the perceived stress scale (pss) i.e. rating ≥ 13 indicates high perception of recent and ongoing life stress * endurance trained or engage in ≥3.5 hours of physical activity a week
cognitive evolution in tysabri treated multiple sclerosis patients - a three year extension

Conditions: Multiple Sclerosis

Summary: this study is designed to demonstrate that tysabri is effective in maintaining cognition in ms patients after 5 or more years of continuous treatment. during a second period of 36 months, the extension study will assess the evolution of cognitive function in tysabri treated ms patients using the symbol digit modalities test (sdmt) and a cogstate battery of tests.

tysabri reduces the relapse frequency, slows progression and preserves cognitive function as compared to placebo as per the affirm trial. the benefit on relapse rate and progression appears to be sustained in longer-term studies such as strata. in clinical practice however despite a stable edss patients often complain of cognitive deterioration. the investigators' preliminary results from the first pilot study have shown that cognition in tysabri treated ms patients for two or more years, as measured by the sdmt or cogstate battery is maintained, including the ability to learn. the investigators' final data will be presented at the american academy of neurology (aan) in 2015. the symbol digit modalities test (sdmt) is a sensitive and validated test of cognition in ms. cogstate offers a standardized battery of cognitive tests frequently used in clinical research in the fields of dementia and parkinson's disease. the cogstate battery of tests consisting of the detection test (processing speed), identification test (attention), one back test (working memory), international shopping list test (verbal learning) and the groton maze learning test (reasoning and problem solving) will further confirm and validate the results of the sdmt in ms patients as well as examine other cognitive domains. the beck depression inventory-ii \[beck 1996\] is a validated and well recognized clinical research tool for depression in the field of multiple sclerosis. together the above tests done prospectively can assess the evolution of cognitive function in tysabri treated ms patients over the longer term.

Eligibility criteria:
inclusion criteria: * patients who have completed the original study and are willing to continue into the extension. exclusion criteria: * patients with cognitive decline from causes other than ms (i.e., pml, stroke, sleep apnea, neurodegenerative disorders, brain tumors).

Keywords: multiple sclerosis cognition
evaluation of the glucoregulatory effects of glucagon-like peptide-1 receptor (glp-1 receptor) activation in participants with type 2 diabetes mellitus (mk-0000-222)

Conditions: Type 2 Diabetes Mellitus

Summary: this was a four-period crossover study to assess the glycemic effects of a single dose of oxyntomodulin (oxm) on the glucose levels in participants with type 2 diabetes mellitus (t2dm). participants were randomly assigned to 1 of 6 treatment sequences consisting of 4 treatment periods, with a 7-day wash-out between each treatment period. the primary hypothesis was that during graded glucose infusion (ggi) oxyntomodulin (oxm) is neutral or better than placebo (pbo) at lowering ambient plasma glucose levels, and at significantly enhancing insulin secretion.


Eligibility criteria:
inclusion criteria: * have a body mass index (bmi) of ≤38.0 kg/m\^2 * have a clinical diagnosis of type 2 diabetes mellitus * have a glycated hemoglobin (hba1c) at screening ≤9.0%; fasting plasma glucose should not exceed 300 mg/dl (16.8 mmol/l) * judged to be in good health exclusion criteria: * have a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study * have a history of stroke, chronic seizures, major neurological disorder, clinically significant endocrine, cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases * have untreated hypertension with blood pressure of \>160/95 mmhg * have a history of neoplastic disease within the past 5 years * have a history of hypersensitivity to oxm, liraglutide, insulin or haemaccel® * unable or unwilling to comply with restrictions around concomitant medications * consume excessive amounts of alcohol, coffee, tea, cola, or other caffeinated beverages daily * have had major surgery, donated or lost 1 unit of blood (approximately 500 ml) or participated in another investigational study within 4 weeks * have a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food * currently a regular user (including use of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months * are unwilling or unable to consume the standardized meals during the study and/or is on a carbohydrate restricted diet (i.e., a diet \<100 grams per day of carbohydrate)
safety and efficacy of turoctocog alfa pegol (n8-gp) in previously untreated patients with haemophilia a

Conditions: Congenital Bleeding Disorder; Haemophilia A

Summary: this trial is conducted globally. the aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (n8-gp) in previously untreated patients (pups) with haemophilia a.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * male, age below 6 years of age at the time of signing informed consent * diagnosis of severe haemophilia a (fviii activity level 1%) based on medical records or central laboratory results * no prior use of purified clotting factor products (5 previous exposures to blood components is acceptable) exclusion criteria: * any history of fviii inhibitor (defined by medical records) - known or suspected hypersensitivity to trial product or related products * previous participation in this trial. participation is defined as first dose administered of trial product * receipt of any investigational medicinal product within 30 days before screening * congenital or acquired coagulation disorder other than haemophilia a * any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise the patient's safety or compliance with the protocol * patient's parent(s')/legally acceptable representative (lar(s')) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation