Kornimate/medical-research-clean huggingface dataset:
physical exercise and mental wellbeing rehabilitation for acute stress-induced takotsubo cardiomyopathy: the please study

Conditions: Takotsubo Cardiomyopathy

Summary: takotsubo cardiomyopathy presents like a heart attack and is typically triggered by intense emotional or physical stress. recovery of this condition varies and many patients continue to suffer from symptoms such as fatigue and breathlessness for a protracted period after their event. research conducted in our unit has found that the heart function does not recover fully as is commonly believed and that the energetic status of the heart remains impaired for an extended period of time. the purpose of our study is to establish whether following a structured exercise program or a mental wellbeing program compared to usual care for 12 weeks after an episode of takotsubo will improve the energy status of the heart, their physical conditioning and improve the general mental wellbeing of patients.

acute takotsubo cardiomyopathy is characterised by sudden onset left ventricular dysfunction precipitated by major stress. the researchers have shown that recovery is more protracted than previously appreciated, and is associated with persistent major morbidity and a long-term heart failure phenotype. in the absence of any effective therapeutic options, the researchers propose a mechanistic three-arm pilot feasibility trial of early rehabilitation (standardised physical exercise training or cognitive behavioural therapy) versus current standard of care in patients who suffered a very recent episode of takotsubo cardiomyopathy. the primary end-point will be the restoration of cardiac energetic status assessed by 31p-magnetic resonance spectroscopy and the secondary end-points of cortisol awakening response, global longitudinal strain by echocardiography and the 6-minute walk test. if successful, this has the potential for rapid implementation into a large randomised clinical trial.

Eligibility criteria:
inclusion criteria: * a patient who has recently suffered an episode of takotsubo cardiomyopathy within the last three weeks * participant who is willing and able to give informed consent for participation in the study. exclusion criteria: * any patient whose takotsubo cardiomyopathy was triggered by a physical illness that would preclude them for taking part in a physical exercise training program. * any patient who is not able or not willing to travel to the cardiovascular research facility for their study visits. * any patient who is not able to commit to a 12 week supervised training program. * inability to exercise on a cycle ergometer (i.e. use of walking aids or prosthetic limbs). * contraindication to magnetic resonance scanning such as an implantable cardiac device. * pregnancy
efficacy analysis of saccharomyces boulardii combined with minocycline in treatment-naïve patients with helicobacter pylori infection

Conditions: H. Pylori Infection

Summary: to assess the efficacy and safety of saccharomyces boulardii combined with triple therapy containing minocycline in the initial eradication of helicobacter pylori (h. pylori) infection


Eligibility criteria:
inclusion criteria: 1. aged 18-70 years, regardless of gender; 2. positive 13c/14c urea breath test result; 3. no previous history of h. pylori eradication treatment; 4. agreement to participate in this study and signing of the informed consent form. exclusion criteria: 1. history of ≥ 1 instance of failed h. pylori eradication; 2. use of antibiotics (including antibacterial traditional chinese medicines), nonsteroidal anti-inflammatory drugs (nsaids), bismuth agents, h2 receptor antagonists (h2ras), proton-pump inhibitors (ppis), and potassium-competitive acid blockers (p-cab) within 4 weeks before treatment; 3. plans to conceive, pregnancy, or breastfeeding; 4. severe liver, kidney, or cardiovascular diseases; malignancies; and alcoholism; 5. allergies to the drugs used in this study or a history of penicillin allergy; 6. the inability to correctly express one's symptoms and wishes, such as inability due to mental illness or severe neurosis.
lenalidomide plus bendamustine and rituximab for untreated cll/sll

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; B Chronic Lymphocytic Leukemia

Summary: lenalidomide belongs to a group of drugs called immunomodulatory drugs (imid) that can modify or regulate the functioning of the immune system. it is an fda approved drug for people with multiple myeloma. it is not currently approved for use in chronic lymphocytic leukemia (cll), but it does appear effective in cll when used alone, and is being studied for use in combination with chemotherapy in this and other lymphomas and leukemias. in this research study we are hoping to learn more about the effects of lenalidomide on cll when given in combination with bendamustine and rituximab, which is a highly effective regimen for initial therapy of cll/sll. the investigators will be looking for the highest dose of lenalidomide that can be given safely, without causing any serious or unmanageable side effects.

subjects will receive lenalidomide, bendamustine and rituximab in cycles of 28 days (4 weeks). lenalidomide will be administered orally once daily on days 8-21 of cycle 1 and on days 1-21 of all subsequent cycles. bendamustine will be administered through a vein (iv infusion) on days 1 and 2 of each cycle. rituximab will be administered as an iv infusion on day 1 of each cycle. subjects will receive routine blood tests and physical exam during each cycle. tumor assessments by ct scan will be performed during cycles 2, 4, and 6.

Eligibility criteria:
inclusion criteria: * diagnosed with b-cell cll or sll (chronic lymphocytic leukemia or small lymphocytic leukemia) * life expectancy \> 3 months * organ and marrow function with protocol parameters * able to take aspirin daily exclusion criteria: * age \>80 years * prior systemic therapy for cll/sll including chemotherapy or antibody therapy * pregnant or breast-feeding * serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent * known hypersensitivity to thalidomide or lenalidomide * prior use of lenalidomide * concurrent use of other anti-cancer agents or treatments * hiv positive * prior history of another malignancy unless disease free for at least 2 years * uncontrolled intercurrent illness

Keywords: cll leukemia untreated b-cll sll
text messaging to reduce high-risk alcohol use among older adults

Conditions: Hazardous Alcohol Use

Summary: high-risk drinking is very prevalent among danes aged 55+. it poses a serious risk to health and independent living, burdening health care systems and family members. measures to reduce high-risk alcohol use in this growing group at need are urgently needed. a recent small study from the us shows that text messaging reduces high-risk alcohol intake in older adults. the investigators will conduct a pilot study with the same intervention in denmark, with adaptations to language and culture. the pilot study will investigate among danish older adults whether text messaging is well-accepted by participants and feasible in terms of reducing 1) high-risk drinking and 2) commonly accompanying problems with daily functioning, social relationships, and mental and physical health. the pilot-trial will include n=60 adults aged 55-80 years who will receive alcohol-related text messages (within a secure app for data protection purposes) over 12 weeks. assessments will include a baseline assessment and a post-assessment.


Eligibility criteria:
inclusion criteria: * consumption of \> 10 standard drinks á 12 gram ethanol per week (i.e., high-risk alcohol use defined by the danish health authority) in the past four weeks * desire to reduce drinking * age 55 to 80 years * mobile phone ownership and willingness to receive and respond to text messages * fluency in danish. exclusion criteria: * drinking more than 53 standard drinks per week in the last four weeks * past 12 month alcohol withdrawal symptoms or lifetime history of serious withdrawal symptoms (e.g., seizures) * score above 12 on the short alcohol withdrawal scale; saws * possible drug dependence (i.e., use of illegal drugs or psychotropic medication taken without prescription more than once a month) * indication of serious psychiatric illness (lifetime diagnosis of psychosis or bipolar disorder, inpatient treatment or medication for these, recent suicidality) * current alcohol/drug abuse treatment or a desire to start alcohol/drug abuse treatment during the study * medical condition that requires abstinence from alcohol * wish to achieve abstinence (applied to secure a focus on reduction) * lack of understanding of study protocol or reading difficulty as evidenced by a score of less than 7 out of 10 on the consent form quiz.

Keywords: older adults digital intervention prevention text messaging
a study of evacetrapib (ly2484595) in participants with hepatic (liver) impairment

Conditions: Hepatic Insufficiency

Summary: the purpose of this study is to measure how much of the drug gets into the bloodstream and how long it takes the body to remove it when given to participants with hepatic (liver) impairment compared to participants with normal hepatic function. information about any side effects that may occur will also be collected. this study will last approximately 28 days, not including screening.


Eligibility criteria:
inclusion criteria: * participants have given written informed consent approved by the ethical review board (erb) governing the site * female participants should be of non-childbearing potential * have a body mass index (bmi) of 18 to 40 kilograms per square meter (kg/m\^2) * healthy participants have normal hepatic function as determined by medical history, physical examination, and other screening procedures * individuals with hepatic impairment classified as child-pugh score a, b, or c (mild, moderate, or severe impairment) exclusion criteria: * has had esophagus variceal bleeding within 3 months of check-in * have the need to take medications that may interfere with how the liver removes the drug * have evidence of cancer in the liver * consumes excessively large amounts of drinks with caffeine or alcohol
scientific substantiation and assessment of the effectiveness of pathogenetic methods of therapy for congenital ichthyosis in children

Conditions: Congenital Ichthyosis

Summary: this is an experimental non-randomized clinical study aimed at expanding the indications for the use of biological drugs with the aim of using them for the pathogenetic therapy of children with congenital ichthyosis.

this is an experimental non-randomized clinical study aimed at expanding the indications for the use of biological drugs with the aim of using them for the pathogenetic therapy of children with congenital ichthyosis. the study will include 50 children aged 6 months to 18 years with a clinically and genetically confirmed diagnosis of congenital ichthyosis. patients will be divided into 4 groups who will receive symptomatic therapy (using active external agents, emollients and / or systemic retinoids) or biologics targeting the cytokines il-12 / il-23, il-4 / il-13 and il -17a. immunophenotyping of all patients will be performed, the cytokine profile and spectrum of sensitization and the degree of nf-kb activation in lymphocytes will be determined. in experimental group №3, 10 patients with netherton syndrome will receive dupilumab, in experimental group №2, 10 patients will receive ustekinumab, and in experimental group №1 10 patients will receive secukinumab. efficiency will be assessed using the ichthyosis area severity index (iasi), determination of the level of tewl, and the change in quality of life will also be assessed using the children's dermatological life quality index (cdlqi) in comparison from baseline, than at 16 and 52 weeks. throughout the study, the safety profile (registration of the development of infectious diseases) will be assessed.

Eligibility criteria:
inclusion criteria: * the subject has signed an informed consent; parental or legal representative consent for patients under 18 years of age, as well as additional consent for patients aged ≥ 15 and \<18. * at the time of participation in the study, the age of the subject is not less than 6 months and not more than 18 years. * at the time of participation in the study, a clinical diagnosis was established: congenital ichthyosis with various clinical forms, with the exception of vulgar and x - linked congenital ichthyosis (genetic research is not a prerequisite for participation in the study). * subjects should have at least moderate iasi erythema associated with his / her ichthyosis, and a decrease in the quality of life according to cdlqi ≥ 10 * absence of signs of severe infectious diseases (pneumonia, tuberculosis, etc.) * no previous history of the use of the following genetically engineered biological drugs: ustekinumab, secukinumab, dupilumab exclusion criteria: * subjects who have an allergic reaction to ustekinumab, secukinumab or other components of the drugs. * subjects who have bacterial and/or fungal diseases. * subjects who have problems in dynamic observation. * subjects who will have a worsening of clinical symptoms

Keywords: congenital ichthyosis netherton syndrome autosomal recessive congenital ichthyosis biologic therapy
stress and coping in caregivers of younger patients with cancer

Conditions: Anxiety; Depression

Summary: this research trial studies stress and coping in caregivers of younger patients with cancer. learning how caregivers of children with cancer experience and cope with chronic stress may help to develop effective programs for reducing caregiver stress.

primary objectives: i. to determine how the experience of distress and use of positive emotion coping strategies by pediatric cancer caregivers differs from caregivers of children with no chronic illnesses. ii. to determine how relationships between positive coping strategies and caregiver distress change during the different phases of a child's illness. iii. to explore how chronic caregiver stress affects physiological reactivity to and recovery from an acute laboratory stressor. iv. to explore how different positive coping mechanisms help chronically stressed caregivers recover from acute stressors and how these efficacies change during the different phases of the child's illness. outline: part i: participants complete a questionnaire that measures several psychological constructs including stress, anxiety, depression, coping mechanisms, uncertainty, positive and negative emotions, and life satisfaction over 15-30 minutes. part ii: participants undergo a trier social stress test during a laboratory session over 1.5 hours.

Eligibility criteria:
inclusion criteria: * ability to read and speak english * must serve as a primary caregiver of their child (ages 0-17) - as reported by the participant * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * (part 1 and part 2): must not have a family member who has already participated in the study * (part 2): must not be pregnant or have a history of cardiovascular disease, hypertension, pituitary disorder, or adrenal disorder * control participants: (part 1 and part 2): participants must not have a child with a chronic illness (e.g., diabetes, asthma, multiple sclerosis)

Keywords: no evidence of disease
use of ecmo in acute mi

Conditions: ECMO and Acute MI

Summary: ecmo offers an acceptable cardiopulmonary support in adults with similar hospital survival rates as other mechanical support. it is versatile and salvages some patients, who may otherwise die. improvement in intermediate term outcome will require multidisciplinary approach to protect organ function and limit organ injury during this support.

extracorporeal membrane oxygenation (ecmo) is an established treatment option in patients with cardiogenic schock. we retrospectively reviewed early and mid-term outcome as well as predictors of survival during using ecmo. this report reviews our experience with this support system in last 3 years.

Eligibility criteria:
inclusion criteria: * acute mi exclusion criteria: * contraindication against ecmo

Keywords: cardiopulmonary resuscitation, ecmo, shock, survival, heart failure, transplantation, heart assist device.
ledipasvir/sofosbuvir fixed-dose combination on cerebral metabolism and neurocognition in treatment-naive and treatment-experienced participants with chronic genotype 1 hcv infection

Conditions: Hepatitis C Virus Infection

Summary: the primary objectives of this study are to evaluate the effect of sustained virologic response (svr) on cerebral metabolism as determined by magnetic resonance spectroscopy (mrs) and on neurocognition as measured by neurocognitive tests. this study will also evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (ldv/sof) fixed-dose combination (fdc) for 12 weeks in treatment-naive or treatment-experienced adults. during the blinded treatment phase, participants will be randomized 2:1 to receive ldv/sof fdc or placebo for 12 weeks. after the unblinding at the posttreatment week 4 visit, participants in the placebo group will be offered open-label treatment of ldv/sof fdc for 12 weeks.


Eligibility criteria:
inclusion criteria: * chronic hcv infection (≥ 6 months) documented by prior medical history or liver biopsy * chronic genotype 1 hcv infection * screening laboratory values within defined thresholds * use of protocol-specified method(s) of contraception if female of childbearing potential or sexually active male exclusion criteria: * clinically-significant illness (other than hcv) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol. current or prior history of any of the following: * hepatic decompensation * solid organ transplantation * significant pulmonary or cardiac disease * chronic liver disease of a non-hcv etiology * hepatocellular carcinoma (hcc) * infection with hepatitis b virus (hbv) * infection with human immunodeficiency virus (hiv) * history of recent epilepsy (within 2 years of screening) or cerebral vascular accident (cva) * structural brain damage * presence of cirrhosis * contraindication to mri * pregnant or nursing female * prior treatment ns5a directly-acting antiviral agent. any interferon (ifn)-containing regimen within 8 weeks of screening
compliance to the treatment with grazax® tablets in patients with seasonal grass pollen rhinoconjunctivitis

Conditions: Allergic Rhinitis; Grass Allergy

Summary: adherence to treatment is crucial to the efficacy of sublingual immunotherapy of allergic diseases. grazax® is a registered drug in europe, with established efficacy in the treatment of allergic rhinitis, which has to be taken daily by patients. this study was aimed to establish if a device with the characteristics of a mechanical dispenser (memozax®) could improve adherence to treatment in subjects with hay fever due to allergy to grass


Eligibility criteria:
inclusion criteria: * a clinical history of grass pollen-induced allergic rhinoconjunctivitis (with or without asthma) having received treatment during the previous grass pollen season. * positive skin prick test (spt) response (wheal diameter ≥3mm) to phleum pratense * positive specific ige against phleum pratense (ige titer \> class 2) exclusion criteria: * clinical history of chronic sinusitis during the last 2 years or of symptomatic perennial or seasonal allergic rhinitis and/or asthma having received regular medication, due to another allergen during - or potentially overlapping - the grass pollen season. * clinical history of severe asthma (gina step 4 and children with forced expiratory volume in 1 second (fev1) \< 80% of expected value after treatment with inhaled corticosteroids and short-acting β2 agonists) * previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years

Keywords: specific allergen immunotherapy sublingual immunotherapy allergen tablets compliance electronic compliance device
immunogenetic profiling of goeckerman therapy in the treatment of psoriasis vulgaris

Conditions: Psoriasis Vulgaris; Psoriasis

Summary: this study examines the effect of goeckerman therapy (a combination of phototherapy and topical crude coal tar), crude coal tar alone, and phototherapy alone on the immunologic and genetic environment within psoriatic skin lesions.

this is a three-arm, open-label study to examine the effect of goeckerman therapy. goeckerman therapy is known for its high efficacy and favorable safety profile in the treatment of psoriasis. it consists of a combination of phototherapy and topical crude coal tar). this study will examine how goeckerman therapy, crude coal tar alone, and phototherapy alone affect the mmunologic and genetic environment within psoriatic skin lesions. fifteen subjects with moderate to severe psoriasis will be enrolled. biopsy samples will be collected and undergo molecular profiling to further elucidate the mechanism of action by which goeckerman treatment improves psoriatic skin lesions.

Eligibility criteria:
inclusion criteria 1. male or female ≥ 18 years of age at enrollment. 2. documentation of predominately moderate to severe plaque psoriasis for at least 6 months prior to enrollment. 3. written informed consent obtained from subject and ability for subject to comply with the requirements of the study. 4. subject is considered a candidate for phototherapy or systemic therapy 5. body surface area (bsa) ≥ 5%. 6. physical exam within clinically acceptable limits. exclusion criteria 1. presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. 2. subject has predominantly non-plaque form of psoriasis. 3. subject has drug-induced psoriasis. 4. subject with current, or a history of, severe psoriatic arthritis well controlled on current therapy. 5. patient has absolute or relative contraindication to phototherapy, including photosensitizing disorders. 6. evidence of abnormality of any immune cell population from a drug-induced or genetic cause. 7. known hiv positive status. 8. known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.

Keywords: goeckerman phototherapy psoriasis