Kornimate/medical-research-clean huggingface dataset:
the effect of the hole in the cardiac septum developed by the mitraclip procedure on the blood flow mechanics

Conditions: Atrial Septal Defect

Summary: patients received a mitraclip procedure because of a leakiness of their mitral valves. during this procedure the atrioventricular valves were stuck together permanently via a clip which leads to a reduction of leakiness. as a result of this procedure a small hole remains at the cardiac septum which is called an atrial septal defect (asd). in most cases the hole will close after a few weeks or months, but in many other cases not. until now there is no exact data about the effect of this hole on the filling pressure in the heart or on the blood flow behaviour. so the aim of this study is a precise analysis of the blood flow mechanics during and after the mitraclip procedure to identify criteria to get more informations for a better strategy and regulation of the mitraclip procedure.

the percutaneous mitral valve reconstruction (pmvr) using the mitraclip system has become an established therapeutic alternative for patients with symptomatic mitral regurgitation and high operative risk. the mitraclip technology represent a catheter-based non-surgical procedure in which a metal cramp (clip) is transported to the place of the defective mitral valve. at the same time, it occurs also a 3-dimensional transesophageal echocardiogram (3d-tee) with a transseptal puncture to control this procedure. after removal of the guiding catheter a new atrial septal defect can develop which can close spontaneously after weeks or months. in this study criteria for a standardized evaluation about the effect of the new asd on hemodynamic parameters - before and after the mitraclip procedure - shall be validated for the first time. the investigators expect to obtain new findings through the exact analysis of the newly formed asd for the planning, regulation and follow-up of the mitral insufficiency treatment.

Eligibility criteria:
inclusion criteria: * patients in which a percutaneous mitral valve reconstruction via the mitraclip system shall be performed due to severe mitral insufficiency because a conventional surgery would be too stressful for them * legal age (≥18 years) * written informed consent prior to study participation * subjects who are contractually capable and mentally able to understand and follow the instructions of the study personnel exclusion criteria: * malignant diseases * varicose veins of the esophagus * patients with central nervous system dysfunction * pregnant and lactating females * subject has been committed to an institution by legal or regulatory order * dependency or working relationship with the investigator * participation in a parallel interventional clinical study

Keywords: mitraclip atrial septal defect iatrogenic
temporal genomics mechanisms underlying disease and aging

Conditions: Gene Expression in Response to Acute Stress

Summary: given the salient role of early-life adversity and the resulting biological embedding in disease risk, there is a critical need to understand the mechanisms operating at multiple levels of analysis in order to promote effective clinical treatments and intervention efforts for survivors. an example for such an effort could be to utilize models of dynamic cellular markers as individual-level factors to account for variation in intervention response and clinical outcomes. results of this study will lead to new knowledge about specific gene expression pathways in response to stress, and whether the response is moderated by previous exposure to early adversity, shorter telomere length (a marker of cellular aging) and self-report mental-health measures. thus, the long-term effects of this study will advance our understanding on stress-related transcriptomic changes that play a downstream role in disease susceptibility and accelerated aging, with the goal of targeting specific pathways and genes for potential intervention studies and pharmacological treatments to reverse the effects of exposure to early adversity. for example, considering high failure rates for depression treatments, and in order to tailor individual interventions, identifying objective changes in stress-induced gene expression may help to predict intervention efficacy in clinical and non-clinical settings, as seen, for example, in breast and leukemia cancers. thus, findings will have a range of impacts for basic science, intervention studies and clinical practice that will influence treatments to match the specific cellular processes operating within an individual.


Eligibility criteria:
inclusion criteria: * age 18-25 * without significant medical illness or endocrine illness (for example, asthma, diabetes, thyroid disease or pituitary gland disorders) * currently non-smokers * not pregnant and had not given birth in the past year * not using medication on a regular basis besides oral contraceptives to allow generalizability to adult women. exclusion criteria: * recent infection or illness * use of abused drugs * immune disease, ascertained during the phone interview.
glowcap reminder system in patients with early stage breast cancer receiving adjuvant endocrine therapy

Conditions: Breast Cancer

Summary: the purpose of this study is to test the ease of using a new device, called the glowcap that reminds the patient to take their breast cancer hormone pill. the study will collect information about the experience with this device and what the patient thinks of its role in the daily pill taking routine.


Eligibility criteria:
inclusion criteria: * early stage breast cancer patients taking adjuvant endocrine therapy (ie, tamoxifen, anastrozole, letrozole, exemestane). * age ≥ 60 years * must have broadband internet access at home (to enable the base for the system to communicate to the vitality server). * must have a landline or mobile phone exclusion criteria: * non-english speaking patients

Keywords: glowcap adjuvant endocrine therapy
multi-omics study of the effect and mechanisms of acupuncture on psychoneurological symptoms among breast cancer survivors

Conditions: Breast Cancer

Summary: the objectives of this study to explore whether acupuncture can improve the psychoneurological symptom cluster (pain, fatigue, sleep disturbance) in survivors of breast cancer and explore biomarker changes after the acupuncture intervention. acupuncture treatments will be provided to breast cancer survivors twice weekly for 5 weeks.

the investigators will conduct the study with early stage breast cancer survivors who have completed their primary cancer treatment. they will all receive acupuncture. treatments will be twice weekly for 5 weeks, for 30 minutes per treatment. at baseline and post-treatment, subjects will be collected blood and stool samples, complete symptom questionnaires that measure pain, fatigue, and sleep disturbance.

Eligibility criteria:
inclusion criteria: * women with histologically confirmed stage 0, i, ii, or iii breast cancer * who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) at least 3 months prior and within 5 years * are currently receiving adjuvant endocrine therapy * are able to read and speak english * with self-reported pain, fatigue, sleep disturbance in the last three months and their "worst" severity rating ≥ 3 (0-10 numeric rating scale) for at least two of the three symptoms exclusion criteria: * have self-reported hospitalization for psychiatric illness within the past 2 years * have a bleeding disorder * physically or cognitively unable to complete the study procedures * pregnant women
pre-operative chemotherapy and radiation therapy for esophageal carcinoma

Conditions: Esophageal Cancer

Summary: surgery (esophagectomy or removal of the esophagus)has been the standard treatment for cancer of the esophagus. however, evidence suggests that preoperative chemotherapy and radiation therapy may add benefit. the purpose of this study is to determine if a treatment program of combined chemotherapy and radiation therapy prior to surgery and chemotherapy after surgery will delay or eliminate recurrence of the cancer.


Eligibility criteria:
patient eligibility: 1. histologically confirmed squamous cell carcinoma, adenocarcinoma, or mixed adeno/squamous of the the esophagus or gastroesophageal junction. 2. disease limited to the esophagus and regional lymph nodes. however, celiac node enlargement will be acceptable for tumors of the distal esophagus, because they will be included in the radiation field. 3. disease must be able to be encompassed in a single radiation field. 4. no medical contraindication to surgery. 5. all treatment is to be administered at the university of michigan medical center 6. karnofsky performance status \> 60% 7. ages 18-75 8. adequate renal function (bun \ 60 ml/min.). 9. adequate bone marrow reserve (wbc\>3500/ul; platelets\>100,000/ul.). 10. adequate hepatic function (bilirubin\<1.5x n; ast \<2 x upper limit of normal). 11. prior malignancy is acceptable if the patient is considered to be cured. in most cases this will mean a 5 year disease-free period. 12. ability to give informed consent. exclusion criteria: 1. patients with active infection, pregnancy, lactating females, serious inter-current medical conditions including congestive heart failure, cardiac arrhythmias, or symptomatic coronary artery diseases are ineligible. 2. no prior treatment allowed. no prior thoracic radiation.
a study to evaluate the safety and tolerability of maralixibat in infant participants with cholestatic liver diseases including progressive familial intrahepatic cholestasis (pfic) and alagille syndrome (algs).

Conditions: Progressive Familial Intrahepatic Cholestasis; Alagille Syndrome; Cholestatic Liver Disease

Summary: this study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children \<12 months of age with alagille syndrome \[algs\] or progressive familial intrahepatic cholestasis \[pfic\].

this is an open label study where all participants will receive maralixibat treatment.

Eligibility criteria:
inclusion criteria: 1. body weight of ≥2.5 kg 2. \ 31 days and \<12 months of age at the baseline visit (us). 3. gestational age ≥36 weeks at birth. for children born with gestational age between 32 and 36 weeks, a postmenstrual age of ≥36 weeks is required. 4. diagnosis of pfic or algs exclusion criteria: 1. predicted complete absence of bile salt excretion pump (bsep) function 2. history of surgical disruption of the enterohepatic circulation 3. history of liver transplant or imminent need for liver transplant 4. decompensated cirrhosis 5. presence of any other disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, including bile salt metabolism in the intestine (e.g., inflammatory bowel disease), per investigator discretion 6. presence of other significant liver disease or any other conditions or abnormalities which, in the opinion of the investigator or medical monitor, may compromise the safety of the participant or interfere with the participant's participation in or completion of the study

Keywords: pfic algs maralixibat bile duct diseases liver diseases biliary tract diseases pediatric
las41005 in hyperkeratotic actinic keratosis

Conditions: Actinic Keratosis

Summary: the aim of this study is to evaluate the efficacy and safety of las 41005 compared to cryotherapy in subjects with moderate to severe hyperkeratotic actinic keratosis (punch biopsies).


Eligibility criteria:
main inclusion criteria: * signed and dated written informed consent. * men and women aged between 18 and 85 years inclusive. * have a general good and stable health condition as confirmed by a physical examination and by medical history. * have at least 4 but not more than 10 clinically confirmed hyperkeratotic ak target lesions of moderate to severe intensity within the face/forehead or bald scalp * skin type i to iv according to fitzpatrick's . * are free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that may cause difficulty with examination or final evaluation. * physical ability to apply the study preparation correctly and to follow the study restrictions and visit. * women of childbearing potential are allowed to participate in this study, only if they use a highly effective method of contraception main exclusion criteria: * have received treatment of ak within the treatment area (face / scalp) in the three months preceding this clinical trial. * have known hypersensitivity to the ingredients * are subjects under immunosuppressive therapy. * having coagulation defects which are inherited or acquired * have evidence of clinically significant, unstable medical conditions * have currently other malignant or benign tumors of the skin within the treatment area * subjects who have taken topical or systemic treatments that might interfere with the study end points, within a time window that is not allowed, or who are currently taking phenytoin, methotrexate or sulfonylurea. * subjects taking inhibitors of dpd (e.g. brivudin, sorivudin) * are known to be pregnant or lactating (currently or within the past 3 months). * have any dermatological disease in the treatment area or surrounding area that may be exacerbated by treatment * are currently or within the past 8 weeks participating in another clinical study. * have active chemical dependency or alcoholism as assessed by the investigator. * subject is institutionalized because of legal or regulatory order.
pedirise feasibility

Conditions: Pediatric Cancer; Financial Stress; Financial Hardship; Disparities

Summary: the goal of this research study is to learn whether investigators can successfully give the pedirise program to families-in other words, whether most families are interested in participating in a study about the pedirise program, including a 50-50 chance of receiving standard usual care, and a 50-50 chance of receiving the pedirise support program. the names of the study groups in this research study are: * pedirise program group * usual care group

this is a pilot, multi-center, randomized research study for the feasibility of the administration of the pedirise program among 40 poverty exposed children with newly diagnosed cancer. randomization means there is an equal chance of being assigned to the pedirise program group or the usual care group. study procedures include screening for eligibility, study visits, and completion of surveys and questionnaires. participation in this study will last for about 6-months. it is expected that about 40 pediatric participants with parents/guardians will take part in this research study. this study is being supported by grants from the american cancer society and the children's cancer research fund.

Eligibility criteria:
inclusion criteria: * child diagnosed with de novo cancer * child has established care at a study site and initiated cancer-directed therapy in the prior 2-months * child planned to receive at least 4-months of cancer-directed therapy at study site from time of diagnosis per initial cancer treatment plan * child is \<18 years at time of enrollment * parent/guardian screened positive for self-reported low-income (\<200% fpl). * family primary residence in ma, ny or nj * provider approval for permission to approach exclusion criteria: * planned transfer of child to a non-dfci or non-columbia facility for cancer-directed therapy * foreign national family receiving care as an embassy-pay patient * child is enrolled on embedded correlative health equity aims of open or upcoming clinical drug trials which are powered on descriptive parent-reported poverty data (e.g. aall1731, ahod2131, anbl2131, dfci 23-001). * child or household member receiving ssi.

Keywords: pediatric cancer financial stress financial hardship disparities
a study in healthy men to test how bi 1358894 is taken up in the body and how food influences the amount of bi 1358894 in the blood

Conditions: Healthy

Summary: the main objective of part 1 of this trial is to investigate the absolute bioavailability of bi 1358894 with an intravenous microdose formulation containing labelled \[c-14\] bi 1358894 and an unlabelled oral tablet formulation of bi 1358894 in healthy male subjects. the main objective of part 2 of this trial is to investigate the relative bioavailability of bi 1358894 administered as an oral suspension.


Eligibility criteria:
inclusion criteria: * healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (bp, pr), 12-lead ecg, and clinical laboratory tests * age of 18 to 55 years (inclusive) * bmi of 18.5 to 29.9 kg/m2 (inclusive) * signed and dated written informed consent prior to admission to the study, in accordance with gcp and local legislation * male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 90 days after trial completion: * use of adequate contraception of the female partner, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device that started at least 2 months prior to first study drug administration or barrier method (e.g. diaphragm with spermicide) or, * sexually abstinent or * a vasectomy performed at least 1 year prior to screening (with medical assessment of the surgical success) or * surgically sterilised female partner (including hysterectomy, bilateral tubal occlusion or bilateral oophorectomy) or * postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with fsh (follicle stimulating hormone) above 40 u/l and estradiol below 30 ng/l is confirmatory) exclusion criteria: * any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator * repeated measurement of systolic blood pressure outside the range of 90 to 140 mmhg, diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 40 to 100 bpm * c-reactive protein (crp) \> upper limit of normal (uln), liver or kidney parameter above uln * any laboratory value outside the reference range that the investigator considers to be of clinical relevance * any evidence of a concomitant disease assessed as clinically relevant by the investigator * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) * diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * further exclusion criteria apply
brain stimulation, clinical symptoms and cognition

Conditions: Schizophrenia

Summary: the purpose of this study is to test the impact of non-invasive brain stimulation, transcranial direct current stimulation (tdcs), on auditory hallucinations, negative symptoms and cognition in schizophrenia. clinical measures will be used to assess clinical symptoms and cognitive performance to test the hypothesis that a course of tdcs can reduce auditory hallucinations and negative symptoms in schizophrenia.


Eligibility criteria:
inclusion criteria: * participants must be able to sufficiently speak and understand english so as to be able to understand and complete cognitive tasks. * all subjects must have the ability to give valid informed consent. * no children under the age of 18 will be recruited. * diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder * stable outpatient or partial hospital status * normal iq (\>70; iq will be measured by administering the wechsler abbreviated scale of intelligence (wasi) test) exclusion criteria: * pacemakers * implanted electrical (brain and spinal) stimulators * implanted defibrillator * metallic implants * skin damage or skin conditions such as eczema at the sites where electrodes will be placed * hair styles hindering the placement of electrodes * cranial pathologies * head trauma * epilepsy * mental retardation * any known history of neurological disorders (including epilepsy, amyotrophic lateral sclerosis (als), multiple sclerosis (ms), stroke, cerebral palsy, any dsm-5 axis i psychiatric disorder (for healthy control subjects), autism) * uncorrected vision problems that would hinder cognitive testing (this also pertains to subjects with color blindness in tasks where discriminating colored objects/items is necessary for successful performance) * pregnancy * substance dependence in the past six months * substance abuse in the past month

Keywords: schizophrenia eeg tdcs dorsolateral prefrontal cortex temporoparietal junction cognitive control auditory hallucinations transcranial direct current stimulation
fixation of skin flaps after mastectomy using running or interrupted sutures for combatting seroma

Conditions: Seroma

Summary: rationale: flap fixation significantly reduces the incidence of seroma formation after mastectomy. therefore, research should focus on finding the most optimal way to secure the skin flaps to the pectoral muscle. previous studies have compared running sutures, interrupted sutures and tissue glue application to conventional wound closure. a recent systematic review with network meta-analysis indicated running sutures as the most optimal technique, however direct comparisons and high quality articles were lacking. objective: this prospective trial aims to directly compare running sutures with interrupted sutures in order to prevent complications in patients undergoing a mastectomy. study design: this trial will combine a retrospective cohort from the previous sara-trial in zuyderland mc with a randomised prospective trial. this study design was chosen to acquire a sample size with sufficient power and the ability to conduct this study in an acceptable time frame. study population: a retrospective cohort of patients participating in the sara trial (rct) and a prospective cohort of patients undergoing a mastectomy for breast cancer. intervention: group 1: flap fixation after mastectomy with running sutures. group 2: flap fixation after mastectomy with interrupted sutures. main study parameters/endpoints: the primary endpoint is the incidence of complications requiring interventions in both groups, including clinically significant seroma, infections and bleeding complications. secondarily, the length of the procedure and cosmetic results will be compared. nature and extent of the burden and risks associated with participation, benefit and group relatedness: when participating, patients will undergo 3 additional outpatient clinic visits. study visits will be combined with regular visits where possible, including the first postoperative visit after 7-10 days and either the 6 week or 3 month visit.


Eligibility criteria:
inclusion criteria: * female sex. * 18 years or older. * indication for mastectomy. exclusion criteria: * patients undergoing breast conserving therapy * patients undergoing direct breast reconstruction * patients undergoing modified radical mastectomy * unable to comprehend implications and extent of study and sign for informed consent