Kornimate/medical-research-clean huggingface dataset:
therapeutic drug monitoring of braf-mutated advanced melanoma

Conditions: Melanoma (Skin)

Summary: braf v600-mutant metastatic melanoma are commonly treated using a combination of anti-braf and anti-mek tyrosine kinase inhibitors (tkis). the optimel trial aims to study the interest of therapeutic drug monitoring (tdm) of tkis and circulating tumor dna (ctdna) detected in plasma of patients with metastatic melanoma for disease monitoring. 35 patients with metastatic melanoma and treated with dabrafenib and trametinib will be enrolled in this trial. blood samples will be collected for the determination of tkis concentration and ctdna detection.


Eligibility criteria:
inclusion criteria: * men and women 18 years of age and older * histologic proven advanced skin melanoma (stage iv or stage iiic inoperable) with braf v600 mutation * patient who will treated with combined kinase inhibitors (dabrafenib + trametinib). * patient able to stand a blood collection of 20 ml * ability to provide an informed written consent form * patient must be affiliated to a social security system * patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study. exclusion criteria: * patient with mucosal melanoma * patient with non-metastatic skin melanoma (all stages except stage iv and stage iii c inoperable) * patient with another synchronous cancer, or within 3 years * patient with a contraindication to blood collection of 20 ml * patient deprived of liberty or under supervision * patient unable to receive kinase inhibitor therapy * patient treated with another combined kinase inhibitors than dabrafenib and trametinib * pregnant or breastfeeding women * patient (man or woman) of childbearing age who does not agree to use of contraceptive methods validated during the study

Keywords: ctdna mapk inhibition braf(v600) mutated
feasibility of slow-paced respiration therapy for treatment of a symptom cluster in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: pulmonary arterial hypertension (pah) is a chronic illness characterized by increased pulmonary pressures resulting in right heart failure and premature death. common symptoms that impair quality of life and functioning are dyspnea, fatigue and sleep disturbance. this trio of symptoms is highly prevalent and forms a symptom cluster (2 or more symptoms that co-occur) in pah. from a biological, proinflammatory cytokines are implicated in dyspnea, fatigue and sleep disturbance; there is activation of the sympathetic nervous system (sns) and an inherent inflammatory process in pah that contributes to the pathophysiology, but the link to this symptom cluster has not been investigated. one novel, treatment for symptom clusters is slow-paced respiration therapy using the fda-approved device, resperate. the device contains headphones and a sensor that attaches to the chest to detect inhalation and exhalation. musical tones synchronize with the respiratory cycle to slowly guide the user to decrease respirations. resperate moderates effects of the sns; lowers blood pressure; improves functional capacity and ejection fraction; and significantly decreases pulmonary pressures in left heart failure. the investigators will enroll 10 women with pah to use the resperate device to perform slow-paced respiration for 15 minutes per day for 8 weeks to determine the feasibility and effects on the sns and inflammatory activity and the symptom cluster. the investigator's overall hypothesis is that, as compared to baseline, after eight weeks of therapy women with pah who receive slow-based respiration therapy will have lower sns activity and inflammatory levels, and improved dyspnea, fatigue and sleep disturbance.


Eligibility criteria:
inclusion criteria: * previous documentation of mean pulmonary artery pressure \> 25 mm hg with a pulmonary capillary wedge pressure (or left ventricular end-diastolic pressure) \ 3 wu at any time before study entry. * women with who group i pah (idiopathic, heritable, or associated with connective tissue disease, congenital heart disease, anorexigens or hiv) * targeted pah therapy at stable dose for 3 months * age \>21 years * ability to perform six minute walk testing without limitations in musculoskeletal function or coordination. * informed consent exclusion criteria: * age \< 21 * hypotension (blood pressure \< 90/60 mmhg) * pregnancy * chronic fatigue syndrome (current or history of) * known sleep disorder (obstructive sleep apnea, restless leg syndrome, narcolepsy, current or history of) * hospitalized or acutely ill * major depression (current or history of) * lung transplant recipient

Keywords: pulmonary arterial hypertension symptoms dyspnea fatigue sleep
a research study looking at how semaglutide works in people with type 2 diabetes in germany, as part of local clinical practice (sure germany)

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to collect information on how semaglutide works in real world patients. participants will get semaglutide prescribed by their study doctor. the study will last for about 6 to 8 months. the participants will be asked to complete some questionnaires about their health and their diabetes treatment. participants will complete these during their normally scheduled visits with their study doctor.


Eligibility criteria:
inclusion criteria: * - signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol) * the decision to initiate treatment with commercially available semaglutide has been made by the patient/legally acceptable representative and the treating physician before and independently from the decision to include the patient in this study * male or female, age 18 years or older at the time of signing informed consent * diagnosed with type 2 diabetes at least 12 weeks prior to inclusion * available and documented haemoglobin a1c (hba1c) value equal to or below 12 weeks prior to initiation of semaglutide treatment exclusion criteria: * - previous participation in this study. participation is defined as having given informed consent in this study * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * treatment with any investigational drug within 90 days prior to enrolment into the study * hypersensitivity to semaglutide or to any of the excipients
safety and efficacy of the vertica® rf device for the treatment of ed

Conditions: Erectile Dysfunction

Summary: adult subjects with mild to moderate and moderate ed who meet the study eligibility criteria will be enrolled in the study. the enrolled subjects will be randomized by a 1:1 ratio to receive the active or sham vertica® treatment. baseline assessments will include collection of demographic data, medical history, concomitant medications and baseline clinical examinations. the initial treatment session will be performed in a clinical setting simulating home use to determine proper device use and to evaluate device tolerability, followed by continued home use of the device for a total of 6 months. patients will be instructed to attempt sexual activity periodically over the course of the study. every time a sexual intercourse is attempted, the patient will be requested to complete an event log using validated assessments. patients will present for monthly follow-up visits, during which safety will be evaluated and additional efficacy assessments will be performed.


Eligibility criteria:
inclusion criteria: * adult, heterosexual, males between 22 and 85 years of age * subjects diagnosed with organic ed for at least 3 months, according to the american urology association (aua) guideline statement 1 (as described in section 8.1.1 of the study protocol). * subjects with an iief-ef score between 11-21 * steady relationship for at least 3 months * subject is sexually active, with at least weekly sexual intercourse attempts or 6 times a month * subject is willing to sign informed consent and follow study protocol procedures * subject has a smartphone exclusion criteria: * castrate and late onset hypogonadism * history of priapism or peyronie's disease * surgery or radiotherapy of the pelvic region * anatomic penile deformations or penile prosthesis * treatment with antiandrogens * previous whole gland treatment of the prostate (cryoablation, hifu, external beam radiation of seed implantation, radical prostatectomy any approach, etc.) * history of urothelial or colorectal cancer * major neurological conditions such as alzheimer's, parkinson, multiple sclerosis, als, spinal cord injury, pelvic neuropathy * evidence of neurogenic bladder or an indwelling foley catheter or clean intermittent catheterization (cic) within 30 days * subjects who are taking anticoagulation or anti-platelet therapy * history of psychiatric disorders, premature ejaculation and drug or alcohol abuse * subjects who are incarcerated * subjects who are cognitively challenged * serious heart or lung disease * pregnant partner
ultrasound capsule endoscopy for esophagus examination

Conditions: Esophageal Diseases

Summary: the aim of this pilot study is to assess the feasibility and safety of the clinical application of ultrasound capsule endoscopy in esophageal examination compared with conventional endoscopic ultrasound examination.

wireless capsule endoscopy has opened a new era by enabling remote diagnostic assessment of the gastrointestinal tract in a painless procedure. however, most commercially available devices only utilise optical imaging to examine the gi wall surface. using this sensing modality, pathology within the gi wall cannot be detected. micro-ultrasound (mus) using high-frequency (\>20 mhz) ultrasound can provide a means of transmural or cross-sectional image of the gi tract. depth of imaging is approximately 10 mm with a resolution of between 40-120 μm that is sufficient to differentiate between subsurface histologic layers of the various regions of the gi tract. ultrasound capsule endoscopy (usce) uses a capsule equipped with mus transducers that are capable of imaging below the gi wall surface, offering thereby a complementary sensing technique to optical imaging capsule endoscopy. in this work, a usce device integrated with a 40 mhz ultrasonic transducer was developed to capture a full 360˚ image of the lumen. previous animal studies of two anaesthetised landrace pigs have demonstrated the effectiveness of the device. the reconstructed images demonstrate clear layer differentiation of the lumen wall. the tissue thicknesses measured from the b-scan images show good agreement with ex vivo images from the literature. the aim of this pilot study is to assess the feasibility and safety of the clinical application of ultrasound capsule endoscopy in esophageal examination compared with conventional endoscopic ultrasound examination.

Eligibility criteria:
inclusion criteria: 1. participants aged 18 years or older. 2. both inpatients and outpatients. 3. healthy volunteers or patients with suspected esophageal disease 4. able to provide informed consent. exclusion criteria: 1. known or suspected complex history of gastrointestinal obstruction, stenosis or fistula. 2. dysphagia. 3. known or suspected possibility of active bleeding of digestive tract. 4. pregnancy or suspected pregnancy.. 5. patients who have participated in or are participating in other clinical trials within three months. 6. life-threatening conditions. 7. other circumstances that doctors consider inappropriate for the study.

Keywords: capsule endoscopy; ultrasound
efficacy and safety of nicvax® co-administered with varenicline (champix®)

Conditions: Smoking Behavior; Smoking Lapse Behavior; Smoking Relapse Behavior

Summary: the purpose of this study is to evaluate the efficacy and safety of nicvax co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.


Eligibility criteria:
inclusion criteria: * smokes at least 10 cigarettes per day * good general health * negative pregnancy test prior to study entry exclusion criteria: * prior exposure to nicvax or any other nicotine vaccine * known allergic reaction to alum or any of the components of the vaccine * use of systemic steroids, immunosuppressive agents or other medication that might interfere with an immune response * cancer or cancer treatment in the last 5 years * hiv infection * history of drug or alcohol abuse or dependence within 12 months * significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease * previous intolerance to varenicline * inability to fulfill all visits for approximately 54 weeks

Keywords: smoking cessation smoking lapse behavior smoking relapse behavior varenicline nicotine conjugate vaccine medication effect on smoking lapse behavior
a suspected association between sarcoidosis and development of diabetes mellitus

Conditions: Sarcoidosis; Diabetes Mellitus

Summary: the purpose of the study is to determine the characteristics of patients with diabetes and sarcoidosis and to compare them with those of patients with diabetes and no sarcoidosis. the investigators will approach these aims by measuring hemoglobin a1c, c peptide, insulin levels, and 2-hour glucose tolerance test results on the study population as well as collecting clinical data from records. three groups of patients will be identified from pulmonary and endocrinology clinics at the university of alabama at birmingham. the first group will have a diagnosis of sarcoidosis without diabetes, the second group will have a diagnosis of both sarcoidosis and diabetes, and the third group will have a diagnosis of diabetes without sarcoidosis. sample size is not pre-determined, but investigators anticipate this number to be less than 100. these patients will be asked in person during an office visit to join the study. for each patient who agrees to join, at a clinic visit, investigators will review and sign consent. following the visit or at a time convenient for each patient, study subjects will undergo a fasting plasma venous sample collection for a hemoglobin a1c, c peptide, insulin level and perform a 2-hour oral glucose tolerance test. the degree of glucose intolerance and prevalence of diabetes will be analyzed and compared between the groups and to historical published control data via t test comparisons. at a later separate visit, patients recruited will undergo ultrasound of the pancreas to assess pancreatic size and morphology.


Eligibility criteria:
inclusion criteria: * any adult patient referred to or followed in uab pulmonary clinic with an established diagnosis of sarcoidosis. any adult patient followed in uab endocrinology clinic with a diagnosis of diabetes mellitus (excluding type 1 diabetes). exclusion criteria: * type 1 diabetes and/or chronic use of corticosteroids.
emotion regulation group skills training for adolescents and parents

Conditions: Behavioral Symptoms; Emotional Instability

Summary: to evaluate if emotion regulation group therapy skills training for adolescents and parents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual.


Eligibility criteria:
inclusion criteria: * being enrolled as a patient at the child- and adolescent psychiatric clinic in linköping * having an adult participant joining the skills training * being between the ages of 14-17 years * having sufficient knowledge of the swedish language exclusion criteria: * clinical diagnosis of schizophrenia * clinical diagnosis of psychosis * clinical diagnosis of severe anorexia nervosa * clinical diagnosis of severe autism spectrum disorder * having a cognitive disability * having an ongoing drug or alcohol abuse * clinical diagnosis of bipolar disorder * insufficient knowledge of the swedish language

Keywords: child psychiatry emotion regulation skills training
yellow fever human infection model with yf-17d

Conditions: Yellow Fever

Summary: no antiviral treatment exists for yellow fever, only supportive care, and therefore we rely on prevention through vaccination. although this vaccine is very effective, stockpiles are insufficient in outbreak situations and some people have a contraindication to be vaccinated. for those who are unprotected and at risk of yellow fever infection, treatment could be life saving.

no antiviral treatment exists for yellow fever, only supportive care, and therefore we rely on prevention through vaccination. although this vaccine is very effective, stockpiles are insufficient in outbreak situations and some people have a contraindication to be vaccinated. for those who are unprotected and at risk of yellow fever infection, treatment could be life saving.

Eligibility criteria:
inclusion criteria: * age 18-50 years exclusion criteria: * contraindication to receive yf-17d (immune deficiency, thymus illness) * previous yf vaccination * pregnancy * chicken egg allergy * hypersensitivity to any other substance in the yf-17d vaccine * interval of \< 4 weeks of another live attenuated vaccine
emerald trial open label extension study

Conditions: Amyotrophic Lateral Sclerosis; Cannabis; CBD; Motor Neuron Disease

Summary: emerald ole trial is an open-label extension of the emerald trial. long term tolerability and safety of the medicabilis cbd oil has not been extensively studied. emerald ole aims to establish data on the prolonged used of the study drug product. all participants who completed the emerald trial will be offered to enter emerald ole. participants will be taking the active drug medicabilis cbd oil for 6 months.


Eligibility criteria:
inclusion criteria: * diagnosed with als/mnd, either definite or probable according to the el escorial revised criteria * can provide written informed consent * able and willing to comply with all study requirement * male or female, 25-80 years old * randomised into the emerald trial exclusion criteria: * participants who are bedridden * history of any psychiatric disorder other than depression associated with their underlying condition including immediate family history of schizophrenia * heavy consumption of alcohol or use of illicit drug * hypersensitivity to cannabinoids or any of the excipients * any of the following: egfr \ 5 x uln * unwillingness of a female participant of child-bearing potential, or their partner, to use effective contraception during the study and 30 days thereafter * pregnant, lactating mother or female participant planning pregnancy during the course of the study and for 30 days thereafter * received any investigational drug or medical device within 30 days prior randomisation except medicabilis cbd oil * any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study * inability to cooperate with the study procedures * unwilling to stop driving vehicle or operating dangerous machinery whilst on study drug. * close affiliation with the study team, e.g. close relative of the investigator
safety and efficacy of bone marrow mnc for the treatment of cerebral palsy in subjects below 15 years

Conditions: Cerebral Palsy

Summary: this study is single arm, single centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 15 years of age) with cerebral palsy in india. primary outcome measures are improvement in walking ability and kinetic gait pattern.

this study is single arm, single centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 15 years of age) with cerebral palsy in india. primary outcome measures are improvement in walking ability and kinetic gait pattern

Eligibility criteria:
inclusion criteria: * subject aged above 3 years and below 15 years with a diagnosis of cerebral palsy. * regional nerve damage as shown by magnetic resonance imaging(mri) * able to comprehend and give written informed consent form for the study * willing to come to the hospital for follow up visits as per the protocol requirements exclusion criteria: * history of meningitis,meningoencephalits,epilepsy or life threatening allergic or immune -mediated reaction 2 * hemodynamically unstable patients * history of or concurrent autoimmune disease or acute episode if guillain- barre syndrome * peripheral muscular dystropy

Keywords: cerebral palsy stem cells [mncs]
pre-workout supplement versus caffeine on energy expenditure.

Conditions: Healthy

Summary: the primary purpose of this study was to examine the acute effects of a multi-ingredient pre-workout supplement versus an ergogenic dose of caffeine (6 mg/kg) on energy expenditure during low-intensity exercise. the effects of these substances on substrate utilization, gas exchange, and psychological factors were also investigated. twelve males (mean ± sd: age = 22.8 ± 2.4 years) completed three bouts of 60-min of treadmill exercise at 4.8-6.4 km/hr on separate days after consuming a pre-workout supplement, 6 mg/kg of caffeine, or placebo in a randomized fashion. the pre-workout and caffeine supplements resulted in significantly greater energy expenditure (p \< 0.001, p = 0.006, respectively), vo2 (p \< 0.001, p = 0.007, respectively), vco2 (p = 0.006, p = 0.049, respectively), and ve (p \< 0.001, p = 0.007, respectively), but not rates of fat or carbohydrate oxidation or respiratory exchange ratio compared to placebo (collapsed across condition). in addition, the pre-workout supplement increased feelings of alertness (p = 0.015) and focus (p = 0.005) 30-minutes post-ingestion and decreased feelings of fatigue (p = 0.014) during exercise compared to placebo (collapsed across condition). thus, the pre-workout supplement increased energy expenditure and measures of gas exchange to the same extent as 6 mg/kg of caffeine with concomitant increased feelings of alertness and focus and decreased feelings of fatigue.


Eligibility criteria:
inclusion criteria: * male exclusion criteria: * history of medical or surgical events, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders; * use of any medications * use of nutritional supplements * habitual use of caffeine (≥1 caffeinated beverage per day) * participation in another clinical trial or investigation of another investigational product within 30 days prior to screening/enrollment.

Keywords: supplementation ergogenic aid metabolic rate energy substrate utilization