Kornimate/medical-research-clean huggingface dataset:
an observational study to describe the effectiveness of angiotensin converting enzyme inhibitor and calcium channel blocker combination in the management of hypertensive patients with elevated heart rate and type 2 diabetes

Conditions: Hypertension

Summary: to describe the effectiveness of angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination on systolic blood pressure (sbp) lowering in hypertensive patients with elevated heart rate and type 2 diabetes


Eligibility criteria:
inclusion criteria: * male or female * ≥ 18 years old * has been already diagnosed with hypertension * has been already diagnosed with type 2 diabetes mellitus * started using angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination within a maximum of 1 week before enrolment * heart rate ≥70 beat per minute exclusion criteria: * pregnant or breast feeding female * current need to use any other antihypertensive drug(s) in addition to angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination * having any contraindication for angiotensin-converting enzyme inhibitor or non-dihydropyridine calcium channel blocker; * has been treated by any anti-hypertensive treatment(s) before angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination * is currently participating in another clinical or non-clinical study

Keywords: hypertension diabetes mellitus ace inhibitors calcium channel blockers
bronchial thermoplasty global registry

Conditions: Asthma

Summary: the primary objective of this registry is to collect real-world data on patients undergoing bronchial thermoplasty (bt) treatment.

this registry is a prospective, open-label, single arm, observational registry to collect outcome data as well as clinical and demographic characteristics of patients undergoing bt treatment in the "real world" setting. patients will be recruited at participating study centers that offer bt as a treatment option to patients with asthma who remain symptomatic despite taking standard of care maintenance medications. the registry will be conducted at up to 80 sites globally and will enroll up to 500 patients. the treatment period is from the date of the first bt procedure until 6 weeks after the third (last) procedure (approximately 12 weeks). the post-treatment period starts at the date of the 6-week follow up visit after completion of the third (last) bt procedure for 2-years of follow-up. the primary endpoint will be the proportion of patients who experience severe asthma exacerbations at 1 and 2 years following bt treatment with the alair system.

Eligibility criteria:
inclusion criteria: 1. patient is an adult aged 18 years or older and is scheduled to undergo bt treatment according to the alair system dfu. 2. patient is able to read, understand, and sign a written informed consent to participate in the registry and able to comply with the registry requirements. exclusion criteria: 1. patient has any medical condition that would make them inappropriate for bt treatment, in the investigator's opinion.

Keywords: asthma bronchial thermoplasty registry device alair
post-traumatic stress disorder (ptsd) and seroquel

Conditions: Post-Traumatic Stress Disorder

Summary: this 8 weeks study will investigate therapeutic responses to seroquel pharmacotherapy in ptsd.

an initial telephone interview will be conducted to determine if potential subjects meet the basic study requirements. if no obvious counterindications are present, subjects will be scheduled for a screening visit. after briefing the subjects on the reasons for the research, they will be given an opportunity to read the informed consent form, approved by the cambridge health alliance institutional reviewboard, and to ask questions prior to signing it. subjects will be given a copy of the signed consent form. each subject will complete a standardized interview schedule designed to obtain personal and background data along with psychodiagnostic and psychometric evaluations. an open-label treatment will be utilized for all patients. seroquel tablets will be flexibly dosed and begun at a target dose of 25 mg per day and taken over an 8 week period.

Eligibility criteria:
inclusion criteria: * provision of written informed consent * fluency in english * a diagnosis of ptsd * no pregnancy * right-handedness exclusion criteria: * pregnancy or lactation * any cognitive impairment that precludes informed consent * known intolerance or lack of response to seroquel * previous enrollment or randomization of treatment in the present study * participation in another drug trial within 4 weeks prior enrollment into this study * patients with diabetes mellitus * history of allergic reaction or hypersensitivity to seroquel * contraindications to magnetic resonance imaging * treatment with an effective medication for ptsd

Keywords: post-traumatic stress disorder ptsd seroquel fmri
ultraviolet and uv-visible light photoprotection for the treatment of melasma

Conditions: Melasma

Summary: melasma is an acquired discoloration of the skin characterized by brown colour changes commonly on the face. the duration of this double-blind clinical trial will be 12 weeks. the control group will receive treatment with topical hydroquinone (4%) and a broad spectrum uv sunscreen. the experimental group, 4% topical hydroquinone and a broad spectrum uv-visible light sunscreen. visible light has melanotic properties and avoiding it can be part of the treatment for melasma patients. the estimated number of subjects to be recruited and randomized for the study is at least 25 per group. the purpose of this study is determine if there is a difference in the improvement between these two sunscreens types. melasma area and severity index (masi) score will be assessed at the beginning of the study and at weeks 4, 8, and 12. photographs, colorimetry and histological assessment will be also evaluated. occurrence of adverse effects will also be recorded.

melasma is a common acquired hypermelanosis in dark skin populations, usually characterized by symmetrical, irregular macules occurring in photo-exposed areas such as face. treatment with sunscreens and depigmenting compounds such as hydroquinone, are still the gold standard in this condition. visible light has pigmenting properties that could be interfering with the treatment in melasma patients. so, the primary objective of this study is to compare the depigmenting adjuvant effect of using a uv-visible blocking sunscreen against a uv sunscreen. patients who are included in the study will be randomly assigned to receive one of the sunscreen type, which should use for 12 weeks. the sun blocking agents should be applied in the affected regions every 3 hours from 8am to 5pm. the evaluation of clinical improvement will be done in a blinded modality by means of the masi score, the global physician assessment, as well as colorimetry and histological melanin content. evaluations will be held on visits at 4, 8 and 12 weeks. skin biopsy will be taken at onset and at 12 weeks. at the end of the study, data will be compared concerning the former parameters. all side effects will be recorded and analysed.

Eligibility criteria:
inclusion criteria: * signed informed consent * women over 25 years of age * dermatologic diagnostic of melasma * phototype iii or more exclusion criteria: * pregnant or breastfeeding * postbirth, abortion in the past 6 months * having an endocrine or autoimmune disease * under hormonal therapy of any kind including contraceptives or it´s use in the past 6 months * currently under treatment for melasma including sunscreens * currently under radiation therapy, chemotherapy, immunosuppressants of any kind or phototherapy or it´s use in the past 6 months * having used or are consuming photosensitizing substances, oral or topical

Keywords: melasma sunscreens visible light ultraviolet light
multiorgan inflammatory syndromes covid-19 related study

Conditions: Covid19

Summary: the study comprise a nationwide, voluntary, on-line survey of inflammatory syndromes in children for retrospective (since 4th march 2020) and prospective data collection. our aim was to capture and describe multisystem inflammatory syndrome in children (mis-c) in poland.

the voluntary surveillance for retrospective (since 4th march) and prospective data collection was initiated under the national consultant of pediatrics auspices. anonymized patient data from pediatric hospitals from all over the country are extracted from electronic and paper records and collected through online form developed for that purpose. before the surveillance was launched, reporting clinicians underwent an online training, which included the current state of knowledge about multisystem inflammatory syndrome in children (mis-c). patient management is at the discretion of the relevant treating clinicians. kd and akd were defined following the american heart association (aha) guidelines. tss was established based on modified criteria by the centers for disease control and prevention. mas was diagnosed based on the paediatric rheumatology international trials organization (printo) criteria for mas classification. the definition of the inflammatory syndrome was based on the who mis-c definition with the exclusion of sars-cov-2 confirmation. for patients who met the inclusion criteria, demographic data, past medical history, data on covid-19 exposure, clinical symptoms, physical examination findings, laboratory, imaging, and cardiologic tests results, treatment, and outcome data are collected. all study definitions are defined in accordance to relevant guidelines and evaluated automatically with the use of a dedicated software.

Eligibility criteria:
inclusion criteria: * patients who required hospitalization since 4th march 2020; * diagnosed kawasaki disease (kd) or incomplete (atypical) kawasaki disease (akd) or toxic shock syndrome (tss) or macrophage activation syndrome (mas) or unspecified inflammatory syndrome; exclusion criteria: * other infectious and non-infectious causes that could be responsible for the disease sars-cov-2 polymerase chain reaction (pcr) or serology result could have been positive or negative. due to limited availability and reliability of serologic testing, proven or likely covid-19 criterion was not a condition determining inclusion to the registry.

Keywords: mis-c pims-ts covid-19 hyperinflammation children
observational study on patients with hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma

Summary: this is an ongoing, longitudinal, single centre, observational, retro-prospective clinical cohort study of patients with hcc in usual clinical practice. all the hcc patients diagnosed and treated in liver cancer center, nanfang hospital are consecutively collected and followed up.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hcc; * age ≥ 16 years; * received treatment targeting for hcc at least once, including operation, ablation, tace, sorafenib, radiotherapy, chemotherapy, etc; * good compliance with clinical treatment. exclusion criteria: * diagnosed as other pathological types such as cholangiocarcinoma, or mixed liver cancer; * received only traditional chinese medicine or symptomatic supportive treatment; (3) survival time ≤ 7 days; * hcc diagnosed after liver transplantation; * poor compliance or important data deficient.
etoposide, methylprednisolone, high-dose cytarabine and oxaliplatin (eshaox) for refractory or relapsed hodgkin's lymphoma (hl)

Conditions: Hodgkin's Lymphoma

Summary: the purpose of this study is to evaluate the efficacy and safety of combination chemotherapy with etoposide, methylprednisolone, high-dose cytarabine and oxaliplatin (eshaox) for patients with refractory or relapsed hodgkin's lymphoma (hl).


Eligibility criteria:
inclusion criteria: * previously histologically confirmed hodgkin's lymphoma * failure to achieve a complete remission with the initial induction chemotherapy, or recurrent disease * performance status (ecog) ≤ 3 * age ≤ 75 years old * number of prior chemotherapies: one or two regimens * at least one or more uni-dimensionally measurable lesion(s) defined as; ≥ 2 cm by conventional ct or ≥ 1 cm by spiral ct or skin lesion (photographs should be taken) or measurable lesion by physical examination * adequate organ functions defined as; anc \> 1,500/ul, platelet \> 75,000/ul, transaminases \< 3 x upper normal values; bilirubin \< 2 mg/dl * written informed consent approved by institutional review board or ethic committee exclusion criteria: * previous high dose chemotherapy with autologous stem cell transplantation or allogeneic stem cell transplantation * previous chemotherapies with eshap regimen * any other malignancies within the past 5 years except skin basal cell carcinoma or carcinoma in situ of cervix * other serious illness or medical conditions * unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry * history of significant neurologic or psychiatric disorders including dementia or seizures * active uncontrolled infection (viral, bacterial or fungal infection) * other serious medical illnesses * pregnancy or breast-feeding, women of childbearing potential not employing adequate contraception * previous history of drug allergy to one of the drugs in the study regimen

Keywords: hodgkin's disease lymphoma relapsed refractory
arteos ii study: relationship between osteoporosis and arterial rigidity within fractured patients cohort

Conditions: Osteoporosis

Summary: the investigators planned to study relationship between osteoporosis and arterial rigidity within fractured patients cohort.


Eligibility criteria:
inclusion criteria: * women and men \> 60 years of age * medical history of low energy fracture * dxa tscore -2,5 ds * free and informed consent signed exclusion criteria: * women and men \< 60 years of age * corticoids treatment * breast cancer or prostat cancer medical history * high energy fracture (traumatic fracture) * no social security affiliation * incapacity to informed consent signed.

Keywords: osteoporosis
evaluation of safety & tolerability of multiple dose regimens of chf 5074 and exploration of effects on potential markers of clinical efficacy in patients with mild cognitive impairment - open label extension (ct04 olep)

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the safety and tolerability of ascending oral doses of chf 5074 after prolonged administration to patients with mild cognitive impairment.


Eligibility criteria:
inclusion criteria: * diagnosis of amnestic or non-amnestic mild cognitive impairment. * mini-mental state examination score higher than 24 at screening. * mri scan of the brain at screening with fluid-attenuation inversion recovery (flair) and t2\*-weighted gradient-recalled-echo (gre) sequences. exclusion criteria: * diagnosis of alzheimer's disease according to the (dsm-iv-tr) or nincds-adrda criteria. * any medical condition that could explain the patients cognitive deficits. * ct or mri brain imaging results obtained within 12 months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance * mri scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm). * geriatric depression scale (30-point scale) score \> 9 at screening. * history of stroke. * modified hachinski ischemic scale score \> 4 at screening. * women of childbearing potential. * vitamin b12 or folate deficiency. * diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening. * current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease. * concomitant use of donepezil at doses \> 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose. * concomitant use of memantine at dose \> 20 mg/day. * concomitant use of psychoactive drugs (sedatives, hypnotics, etc).
mechanisms of dysfunction and the influence of exercise on cardiac and musculoskeletal function

Conditions: Congenital Heart Disease

Summary: primary objective: to determine if impairments in cardiac and musculoskeletal function and metabolism exist in fontan children. secondary objectives: 1. to determine if impairments do exist, are they related to exercise capacity. 2. to determine if a 12-week exercise training intervention improves cardiac and/or musculoskeletal metabolism. hypothesis: the investigators hypothesize that abnormalities in cardiac and skeletal function are evident, influence exercise capacity, and can be improved with exercise training.

this proposed research provides an interdisciplinary approach to understanding exercise intolerance by examining cardiac and musculoskeletal metabolism in a unique cohort of children with congenital heart disease. study findings may more importantly lead to evidence-based exercise interventions that promote improvements in overall physical health, quality of life, and functional status for fontan children. furthermore, this pilot study will lead to the development of a novel research protocol which may be applied to larger fontan and other congenital heart disease cohorts. this study will also provide preliminary data to develop and conduct a larger clinical research project.

Eligibility criteria:
inclusion criteria: fontan patients: 1. patients who have had the fontan cardiac procedure 2. 10-16 years of age 3. written informed consent healthy controls: 1. 10 - 16 years of age 2. written informed consent exclusion criteria: fontan patients: 1. contraindication to exercise 2. physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (strong et al., 2005) 3. patients in whom mri is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos) 4. patients with a known allergy to gadolinium. 5. patients with a history of allergic disposition or have anaphylactic reactions 6. moderate-to-severe renal impairment (defined as having a gfr/ egfr \< 60 ml/min) 7. have sickle cell anemia 8. known pregnancy, or breast feeding 9. patient is uncooperative during a mri without sedation or anesthesia healthy controls: 1. contraindication to exercise 2. physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (strong et al., 2005) 3. patients in whom mri is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos, pregnancy) 4. patient is uncooperative during a mri without sedation or anesthesia

Keywords: pediatric fontan congenital heart disease cardiac and musculoskeletal funion cardiac and/or musculoskeletal metabolism exercise training intervention
continuous administration of oral contraceptive, primary dysmenorrhea

Conditions: Dysmenorrhea

Summary: the primary hypothesis is that continuous administration of an ocp (ccocp regimen) will result in more pain relief than a traditional 21/7 administration in primary dysmenorrhea (pd) patients.

it is well established that excess prostaglandin production in primary dysmenorrhea (pd) leads to ischemia of the uterine muscle, which consequently causes pelvic pain. a large number of drugs have been studied for pain relief in dysmenorrhea patients with non-steroid anti-inflammatory drugs (nsaids) being the most effective with the overall success rate of more than 75%. oral contraceptive pills (ocp) are also an established treatment for pd with the success rate of 70%. lately, ocp's have been used continuously in patients with endometriosis and had better pain control than traditional administration of ocp.

Eligibility criteria:
inclusion criteria: * healthy women ages 18-35 with a history of pd (onset \< 3 years after menarche). * subjects must have had regular (25-31 day) menstrual cycles for the three month period preceding enrollment, with symptoms of moderate to severe pd during those cycles. exclusion criteria: * patients who have contraindications to ocp therapy. * known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, pelvic inflammatory disease (pid), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, inflammatory bowel disease, irritable bowel syndrome). * concomitant treatment with oral contraceptives, gnrh agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs. * the use of contraceptive implants, injectable contraceptives or intrauterine devices. the washout period on all these medications will be 3 months. * migraines, depression requiring hospitalization or associated with suicidal ideation during previous estrogen or ocp use. * known or suspected hypersensitivity to trial drug. * patients enrolled simultaneously into other investigative studies that require meds.

Keywords: dysmenorrhea continuous ocp
biomarkers of sarcopenia and frailty in geriatric patients

Conditions: Sarcopenia; Muscle Loss; Fall Patients

Summary: during the last decades there has been an increase in the relative proportion and life expectancy of elderly people. hence, the number of elderly with diseases and disabilities related to aging will increase and consequently, age-related losses in skeletal muscle mass and physical function represents an important current and future public health issue. sarcopenia is a progressive and generalized skeletal muscle disorder that is considered central to the development of physical deconditioning and untreated sarcopenia is linked to falls, morbidity, and mortality. the underlying mechanisms behind the progressive loss of muscle mass and function associated with aging are yet unknown but seems to be multifactorial. a decrease in physical activity level and an altered central and peripheral nervous system innervation have been identified as some of the contributing factors. furthermore, chronic low-grade inflammation has been proposed as a central contributor to sarcopenia and thus physical frailty. however, it is not yet clear whether the elevated markers of inflammation seen in the elderly are due to aging, chronic illness, or inactivity. but overall, it seems that inflammation plays an important role in the development of muscle loss, and is related to increased risk of falls, fragility, and early death.


Eligibility criteria:
inclusion criteria: * geriatric patients referred to out-patient clinic for fall assessments * equal to or over the age of 65 exclusion criteria: * age under 65 years * participants who do not understand danish * severe communicative problems * moderate to severe dementia or cognitive deficits * no independent walking