Kornimate/medical-research-clean huggingface dataset:
pilot study of the ehealth application "cancer patients better life experience" (capable) - italy

Conditions: Renal Cell Carcinoma Metastatic; Breast Cancer; Head and Neck Cancer; Thyroid Cancer; Ovary Cancer; Lung Cancer; Stomach Cancer

Summary: the purpose of the capable study is to compare health-related quality of life in renal cell carcinoma patients who use or do not use a mobile-based application to monitor adverse events for cancer treatment at home. as secondary objectives, the study investigates the usability of the system and its generalizability to other cancer types

the study is designed as a prospectively enrolling, quasi-experimental cohort study in cancer patients, eligible for systemic treatment. the capable cohort will receive the smartphone application and a multi-sensorial smartwatch (asus vivowatch 5 hc-b05). patients will be asked to use the system for at least 6 months after enrollment. if, after 6 months, a patient wants to keep using the system, he will be allowed to do so, until the end of the study. questionnaires on health-related quality of life will be administered to the patients on baseline (t0) and every three months (t1 and t2). lost to follow-up data will be included in intention-to-treat analysis. qualitative and quantitative user experience studies will be done at enrollment, after 3 months and at the end of the follow-up period with the capable system. results of this interventional study will be compared with a control cohort consisting of renal cell carcinoma patients, recruited in 2021 with the same inclusion criteria as this study population, but receiving standard care (icsm ce number 2546, dated 13/04/2021 and amended on 09/02/2022).

Eligibility criteria:
inclusion criteria: * adults (age \>=18 years) * sufficient understanding of the italian language * patients or their caregiver (upon patient's consent) can use a smartphone * histologically or cytologically confirmed diagnosis of rcc, lung, breast, thyroid o head and neck cancer * candidate to systemic treatment (targeted agents, immune checkpoint inhibitors, or a combination of the two) * eastern cooperative oncology group (ecog) performance status 0 or 1 at the start of the treatment. exclusion criteria: * recruitment and consent denial * not able of understanding and complying with the protocol requirements (including basic technological abilities) * given the fact that each subject involved in the clinical study must be able to understand and sign the informed consent presented by the researcher, lack of this capability represents a specific exclusion criterion in the study protocol.
acetazolamide to prevent post operative csf leak

Conditions: Cerebrospinal Fluid Leak

Summary: the purpose of this research is to test the use of acetazolamide in preventing post-operative cerebrospinal fluid leak in patients having endoscopic skull base surgery (it is a surgery performed through the nose and sinus).


Eligibility criteria:
inclusion criteria: * elective transsphenoidal resection of a tumor expected to result in an intraoperative high flow csf leak; such tumors include craniopharyngioma, meningioma, and rathke cleft cyst. * elective transsphenoidal resection of a pituitary adenoma, with bmi \>25, or with observed low or high flow csf leak during surgery, conferring an elevated risk of postoperative csf leak. * patients who voluntarily sign informed consent * male subjects and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception during study treatment and for at least 1 month after stopping study treatment. male subjects should refrain from donating semen during treatment and 1 month after stopping treatment. exclusion criteria: * adults unable to consent * individuals who are not yet adults (infants, children, teenagers) * pregnant women * prisoners * patients with prior adverse reactions to acetazolamide or who are taking aspirin concomitantly (which may increase the risk of adverse reactions to acetazolamide) * patients with moderate to severe chronic obstructive pulmonary disease (which may increase the risk of adverse effects of acetazolamide) * acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis. * it is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy * sulfonamide allergy * pregnant females, breastfeeding females, and males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception
prehabilitation effect on function and patient satisfaction following total knee arthroplasty

Conditions: Prehabilitation; Knee Osteoarthritis

Summary: knee arthrosis has a high prevalence. non-surgical treatment, such as exercise, is the first choice of treatment. however, most patients end up having a surgical procedure such as total knee arthroplasty. following surgery with total knee replacement as much as 20% of patients report to not be satisfied with the results. it is noteworthy that this level of dissatisfaction has persisted over the last decades despite formidable progress in surgical methods and technology. leg strength prior to surgery is associated with faster recovery post operatively, which may influence satisfaction. the investigators aim is to implement a period of strength training prior to surgery to evaluate if training prior to surgery may reduce the level of dissatisfaction post operatively.


Eligibility criteria:
inclusion criteria: * knee artrosis, refered to surgery exclusion criteria: * kognitive disability * inflamatory disease in muscles * varus/ valgus and extension deficit \>15 degrees * neurological disorders
a safety study of sea-bcma in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: this trial will study sea-bcma to find out whether it is an effective treatment for multiple myeloma (mm) and what side effects (unwanted effects) may occur. the study will have several parts. in parts a and b, participants get sea-bcma by itself. this part of the study will find out how much sea-bcma should be given for treatment and how often. it will also find out how safe the treatment is and how well it works. in part c of the study, participants will get sea-bcma and dexamethasone. in part d, participants will get sea-bcma, dexamethasone, and pomalidomide. dexamethasone and pomalidomide are both drugs that can be used to treat multiple myeloma. these parts of the study will find out whether these drugs are safe when used together.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of mm * must have mm that is relapsed or refractory * has received a proteasome inhibitor, an immunomodulatory drug, and an anti-cd38 antibody * measurable disease, as defined by at least one of the following: (1) serum m protein 0.5 g/dl or higher, (2) urine m protein 200 mg/24 hour or higher, and (3) serum immunoglobulin free light chain (flc) 10 mg/dl or higher and abnormal serum immunoglobulin kappa lambda flc ratio. * eastern cooperative oncology group (ecog) status score of 0 or 1 * life expectancy of greater than 3 months in the opinion of the investigator * adequate hematologic, renal, and hepatic function exclusion criteria: * parts a and d: prior treatment with a bcma-directed therapy * history of another malignancy within 3 years * active cerebral or meningeal disease related to the underlying malignancy * uncontrolled grade 3 or higher infection * prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. prior car-t-cell therapy must be completed 8 weeks before first dose of study drug. * combination therapy only: 1. known intolerance to corticosteroids 2. uncontrolled psychoses

Keywords: rrmm antibodies, monoclonal antigens, bcma immunotherapy hematologic diseases myeloma seattle genetics
responses of people with neck pain being treated with varying doses of manual therapy: a pilot study

Conditions: Whiplash Injuries

Summary: the purpose of this pilot project is to determine the feasibility of a study design to investigate how many sessions of manual therapy and exercise produce the best results for people with whiplash injuries. also, this study will help us determine the best way to measure the effect of treatment. finally, the investigators will study how closely the physiotherapists follow the treatment instruction provided in the study protocol and training. in order to achieve these objectives, 12 people will receive manual therapy and exercise at one of twelve different doses. the investigators will have each of these people fill out questionnaires, measure sensation changes, and measure changes in the way people move their necks while walking. this study will help us determine if the study protocol can be carried out as planned. this includes: the training of all people involved in carrying out the assessments and treatments, the willingness and ability of participants to take part in all of the treatment and measures involved. this will provide us with important information to help us plan a larger study with 226 people with whiplash injuries.


Eligibility criteria:
inclusion criteria: * adults ≥ 21 years * main complaint must be neck pain, but we expect some patients will also report symptoms that radiate to the shoulder and arm regions or have an associated headache. * pain intensity must be ≥ 12/40 on the 4-item pain scale (p4). exclusion criteria: * non-mechanical sources of neck pain or over-riding comorbidity listed below: * rheumatoid arthritis * neurological diseases * fractures * dislocation * rheumatoid arthritis * upper motor neuron dysfunction or malignancy * pregnant women * closed head injury * on steroid-based medications within the past 6 months.

Keywords: whiplash neck pain manual therapy exercise dosage
study of serum testosterone levels in non-dosed females after secondary exposure

Conditions: Hypogonadism

Summary: to further characterize the transfer potential of marketed testosterone gel and new 1.62% formulation.


Eligibility criteria:
inclusion criteria: * healthy male and female volunteers, with a bmi 20-35 kg/m2 (males) and 20-30 kg/m2 (females). exclusion criteria: * males: history, current or suspected prostate or breast cancer. * female: pregnant or lactating.

Keywords: testosterone replacement therapy
comparing symbicort® as-needed or bricanyl as-needed or pulmicort® once daily + bricanyl as-needed in asthma patients

Conditions: Exercise Induced Asthma

Summary: 1. the primary objective of this study is: * to evaluate the magnitude of the protective effect of the combination of budesonide and formoterol on an as-needed basis compared to the use of terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma 2. the secondary objectives of this study are: * to evaluate the magnitude of the protective effect of the combination of budesonide and formoterol as-needed compared to regular once daily use of budesonide plus terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma * to evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and regular use of budesonide + terbutaline as-needed as terms of adverse event


Eligibility criteria:
inclusion criteria: * history of exercise induced asthma * maximum 4 asthmatic episodes per week requiring use of reliever medication exclusion criteria: * no previous treatment with inhaled oral corticosteroids during the last month before randomisation * suspected poor capability to follow instructions, ie to exercise 3-4 times a week

Keywords: exercise induced asthma mild intermittent asthma exercise induced bronchoconstriction
evaluation of cicaplast in subjects with skin irritation

Conditions: Skin Diseases

Summary: the aim of this open, before/after, multicentric study is to assess the effect and tolerance of cicaplast baume b5 in patients having a skin irritation (irritative and cracked dermatitis, dry eczematids, rubbing irritation, ...) under dermatological control. patients are asked to apply the product at least twice a day until complete recovery (maximum 21 days).

dermscan has implemented a quality management system which has been certified by the international standards organization (iso 9001: 2015). this quality assurance system includes appropriate good clinical practices (gcp) and regulation requirements. the proofreader is not involved in the audited study. a certificate of quality inspection signed by the person who checked the report is enclosed in each study. statistical method regarding the descriptive analysis, the quantitative data is summarized using the following statistics by time point: * number of values * mean * median * standard deviation (sd) * minimum value * maximum value. are summarized in frequency (n) and percentage (%) by time point: * the investigator's global assessment (iga) score assessed by the investigator using a 6-point scale * the soothing effect assessed by the subject using a 4-point scale for the parameters pain and pruritus * each global tolerance score assessed by the investigator and by the subject using a 4-point scale. the score of anti-irritating effect (score de reparation de l'epiderme= scorepi) is summarized using statistics for quantitative variables at each time point. the local signs of irritated area assessed using a 4-point scale (erythema, desquamation, pigmentation, cracks, oedema) are summarized in frequency (n) and percentage (%) and by time point and by parameter.

Eligibility criteria:
inclusion criteria: * subjects presenting the following skin irritations (at least 3 to 5 per irritation): irritative and cracked dermatitis, dry eczematids/dry patches, rubbing irritation in specific location (ex: thumb frictions, lichenifications), ... * localization of irritation lesions: face, limbs, trunk, feet, fold, hands, ... * subjects having a feeling of discomfort at the site of the lesion. exclusion criteria: * cutaneous pathology on the studied zone (other than the required irritations) * use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous acceptability of the study product (according to the investigator's appreciation); * subject with healing disorder (keloid, hypertrophic) * subject with type 1 diabetic * subject under chemotherapy and radiotherapy * subject with a skin disease on evaluation site: psoriasis and atopic dermatitis active lesions and hand dermatitis

Keywords: skin irritation irritative dermatitis superficial burn
the efficacy of the nanit-insights app in improving infant sleep

Conditions: Infant Sleep Problems

Summary: the proposed study aims to examine the effectiveness of nanit-insights, an app-based intervention for parents who wish to improve their infant's sleep.

the proposed study aims to examine the effectiveness of nanit-insights, an app-based intervention for parents who wish to improve their infant's sleep. the intervention provides parents with daily sleep metrics as well as personalized sleep recommendations, based on their infant's developmental stage and weekly sleep data. participants will be parents of 5-7 month-old infants, randomized into one of two groups: (1) the intervention group, which will include users who have purchased the baby monitor without subscribing to nanit insights and are then offered a six month subscription to nanit-insights when their baby is 5-7 months of age; and (2) the control group, which will include users of the baby monitor, who have not subscribed to nanit-insights. each group will include approximately 150 families. sleep will be assessed at baseline and 3- and 6-months following the beginning of the intervention. computer vision technology will be used to assess infant sleep, as well as parental adherence to the intervention, allowing us to determine whether adherence mediates sleep benefits. the results of this study are expected to evaluate the effectiveness of a low-cost, app-based intervention for infant sleep problems. furthermore, the results may broaden the understanding of the mediating role of parent adherence in such interventions.

Eligibility criteria:
inclusion criteria: * infant aged 5-7 months * presence of a moderate to severe sleep problem at baseline * sleeping arrangement in which the infant sleeps in a crib at night exclusion criteria: -
a long-term treatment study of ach-0144471 in participants with paroxysmal nocturnal hemoglobinuria (pnh)

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: the purpose of this study is to evaluate the long-term safety and efficacy of ach-0144471 in participants with paroxysmal nocturnal hemoglobinuria (pnh) who have demonstrated clinical benefit from ach-0144471 in study ach471-100. this study is designed to include up to 12 participants.


Eligibility criteria:
inclusion criteria: * study designed to include up to 12 participants who completed treatment in study ach471-100 and demonstrated clinical benefit from ach-0144471 with no significant safety or tolerability concerns. * negative pregnancy test for females prior to dosing and throughout the study. exclusion criteria: * have developed any clinically relevant co-morbidities while participating in study ach471-100 that would make the participant inappropriate for the continuation of treatment with ach-0144471, in the opinion of the investigator. * have developed any clinically significant laboratory abnormalities while participating in study ach471-100 that, in the opinion of the investigator, would make the participant inappropriate for the study or put the participant at undue risk. * females who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration or participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration.

Keywords: pnh paroxysmal hemoglobinuria ach-0144471 alxn2040 danicopan
incidence, clinical characteristics and outcomes of unstable angina in the contemporary area.

Conditions: Unstable Angina

Summary: the study aims to evaluate clinical characteristics and prognostic of a contemporary population of patients with ua defined using t hs-ctn measurements the study includes all patients admitted in 2 french university centers with the confirmed diagnostic of ua defined with clinical ischemic symptoms and t hs-ctn concentrations \< 99 percentile (undetectable: \<5ng/l or non-elevated: \<14ng/l), or ≥ 99 percentile but mildly elevated (14-50ng/l) .the primary end-point included major events at 1-year follow-up (total mortality, new acs, hospitalization for cardiac causes).


Eligibility criteria:
inclusion criteria: * patients with ischemic symptoms at rest or minor exercise without evidence of acute myocardial necrosis. * ischemic symptoms may include typical or atypical angina pectoris and worsening/deterioration of previously stable angina with or without electrical signs of ischemia on the electrocardiogram. * hs-ctn concentrations are in the normal range or may be slightly elevated \> 99th percentile (i.e. low troponin t elevation ≤ 50 \* elecsys roche) but with absence of significant kinetics according to criteria defined in the literature (\<20%). * one of the following angiographic criteria is required: * coronary angiography revealing a stenosis with a diameter of at least 70%. * stenosis of at least 50% diameter in the left common trunk. * ffr (fractional flow reserve) documenting ischemia per coronary angiography of a coronary lesion in the case of intermediate stenosis (50-70%). * if there are no significant lesions, a spasm must be proven by an ergonovine test. exclusion criteria: * nstemi and stemi. * coronaries normal or without significant lesions unless proven spasm.

Keywords: cardiology
study to assess the effectiveness of a omega-3 enriched supplement on chemotherapy tolerance in colon cancer patients

Conditions: Colorectal Neoplasms

Summary: the purpose of this study is to determine if a nutritional supplement enriched in omega-3 fatty acids is effective in improving the tolerance to chemotherapy treatment and improves quality of life.

colorectal cancer is one of the main causes of mortality in western countries. it is considered that in case of colorectal carcinoma, the frequency of weight loss at the moment of diagnosis is 54%. undernourishment affects negatively the course of the illness and it confers a worse prognostic, increasing the morbidity and the mortality, while it entails an impairment in the quality of life of the patient. there is a narrow relationship in the oncologic pathology between undernourishment and the pathology itself, drawing a common syndrome called cancerous cachexia. it is usual that patients subjected to chemotherapy present nutritional alterations due to the treatments' side effects. with this study we want to assess the efficacy of a nutritional intervention with supplementation enriched in epa to improve the tolerance to the antineoplastic treatment. as an index of tolerability to the chemotherapy treatment, it will be used the variation of changes in quality of life evaluated through the questionnaire eortc qlq-c30, using the parameters of global quality of life and physical function.

Eligibility criteria:
inclusion criteria: * patients diagnosed of metastatic colon adenocarcinoma that are going to receive first line chemotherapy treatment in the oncology day hospital. * age over 18 years old. exclusion criteria: * patients diagnosed of colon cancer are receiving second line chemotherapy. * antecedents of other malignant tumors with the exception of basocellular epithelioma. * chronic renal failure (creatinine \> 1.7). * previous diabetes mellitus. * obesity (imc \> 30) * medical conditions that imply hepatic encephalopathy, or ascites. * severe malnutrition according to the classification of the subjective global assessment (sga) or a bmi \< 16.5. * major psychiatric disorder. * patients receiving enteral or parenteral nutrition. * contraindications for the indication of the nutritional supplement: galactosemia. * seafood or seafood byproducts allergy. * patients taking drugs that affect the metabolism (anabolic steroids, orexigenic agents...). * absence of the informed consent form signed by the patient. * any patient who has disability to comply with the treatment or who has inability according to the researcher.

Keywords: colorectal neoplasms eicosapentaenoic acid quality of life nutritional status