Kornimate/medical-research-clean huggingface dataset:
pilot study to investigate the creation of physiological rhythm by closed loop stimulation in heart failure patients with chronotropic incompetence

Conditions: Heart Failure; CPX

Summary: the study assesses the effect of closed loop stimulation (cls) on the ventilatory efficiency slope and estimates the patient responder rate to cls in patients with severe chronotropic incompetence treated with a cardiac resynchronization therapy (crt) device.

in patients with pharmacological refractory heart failure (hf), systolic dysfunction, and cardiac dyssynchrony, the cardiac resynchronization therapy (crt) reduces the risk of death, and improves symptoms and quality of life. a considerable portion (80%) of patients with a crt indication has a chronotropic incompetence (ci). ci usually induces a stress intolerance which negatively affects the quality of life. in addition of being a marker of diminished exercise capacity, severe ci (sci) may be an independent predictor of mortality. the sensor-based rate adaption provided by the implanted crt device delivers a possible therapeutic approach for the ci. usually, rate adaption is achieved by an accelerometer. the previous studies in terms of effectiveness of rate adaption in crt patients with ci showed inconsistent results. in addition to an accelerometer to deliver the rate adaption biotronik provides closed loop stimulation (cls) as unique feature in a crt device. cls determines the appropriate heart rate based on intra-cardiac impedance measurements. these measurements reflect changes of the cardiac contraction dynamics in reaction to information coming from the autonomic nervous system. cls takes the information on the contraction dynamics and translates it into an adequate heart rate adaptation, thus delivering physiologically appropriate therapy.

Eligibility criteria:
inclusion criteria: * crt class i indication at time of implantation, according to current guidelines * implantation of crt-device including cls \> 6 months prior to enrollment * stable heart failure status for at least 1 month * optimal cardiovascular drug treatment according to current guidelines * nyha class ii or iii * patient is able to comply with the protocol * patient provided written informed consent * stable location of residence exclusion criteria: * planned cardiovascular intervention within the next 3 months * admission for decompensated heart failure or acute coronary syndrome in the preceding 3 months * ongoing symptoms of myocardial ischemia * known persistent, long-standing persistent or permanent atrial fibrillation * copd with gold ≥ 3 * planned absence of residence for more than one week during study period * pregnant or breast-feeding women * participation in another interventional clinical investigation * age \< 18 years * placed in an institution due to official decree or judicial order * dependent from the sponsor, the clinical site or the investigators
efficacy and safety of photodynamic therapy for cervical and vaginal intraepithelial neoplasia

Conditions: Precancerous Cervical Lesion

Summary: to investigate the efficacy and safety of photodynamic therapy (20% 5-amino-ketovalerate 630nm red light) in the treatment of cervical and vaginal intraepithelial neoplasia in women in the real world.


Eligibility criteria:
inclusion criteria: * cervical/vaginal high-grade squamous intraepithelial lesions (hsils) confirmed by colposcopy and pathological biopsy (cin2 /cin3 and/or vain2/ vain3) or persistent cin1/vain1 lasting for more than one year with a strong willingness to treat; * colposcopy was adequate, and analysable colposcopy images were retained; * endocervical curettage (ecc) did not suggest higher-grade lesions. exclusion criteria: * coexistence or suspicion of cancer; * porphyria or suspected allergies to red and blue light; * severe medical comorbidities；

Keywords: ala-pdt hpv cin vain
aortic stenosis in elderly : determinant of progression

Conditions: Aortic Stenosis; Elderly Gravida

Summary: aortic stenosis (as) is as is caused by calcium deposits in the aortic valve. calcification is progressive and eventually leads to reduced leaflet motion with obstruction of the left ventricular outflow. the only treatment is surgery. there are evidences that as is a regulated process with similarities to atherosclerosis but determinants of as progression are unknown. the study aims at evaluating these determinants and more specifically the role of lipids, inflammation and platelet aggregation.

aortic stenosis (as) is the most common valvular disease and the second most common indication for cardiac surgery in western countries. as prevalence increases with age and with aging of the population, as is a major public health problem. as is due to calcium deposits within the aortic valve. calcium deposit is progressive and eventually leads to reduced leaflet motion with obstruction of the left ventricular outflow. there is currently no effective medical therapy. once the stenosis is severe and patients symptomatic, outcome is poor unless surgery (aortic valve replacement) is promptly performed. as has long been considered as a passive and degenerative process. recent data challenged this concept, showing that as is an active and highly regulated process with some similarities to atherosclerosis. however, as progression is highly variable from one individual to another and determinants of as progression are poorly known. their identification is crucial if we want to develop new medical strategies. the aims of the present study are to identify the determinants of as progression and more specifically to evaluate the role of lipids, inflammation and platelet aggregation.

Eligibility criteria:
inclusion criteria: * age ≥ 70 years * as with mean transmitral gradient \> 10 mm hg and aortic valve area \< 2 cm2 * no surgical indication exclusion criteria: * rheumatic or congenital as * associated valvular disease grade ≥ 2/4 * indication for surgery (severe as (aortic valve area \< 1 cm2 or \< 0.6 cm2/m2 of body surface area and symptoms or congestive heart failure or left ventricular ejection fraction \< 50%) * renal insufficiency (creatinine clearance \< 30 ml /min) * left ventricular outflow tract obstruction

Keywords: aortic stenosis elderly
dysbiosis in bipolar disorder

Conditions: Bipolar Disorder

Summary: the gut microbiota is a complex community comprising around 10\^14 bacteria that live in the gut lumen. the imbalance of the normal structure and function of the microbiota, defined as dysbiosis, has been related to a wide diversity of pathologies, including mental health disorders. however, clinical evidence of the relationship between microbiota and mood disorders is lacking. the aim of this project is to examine the possible relationship of gut dysbiosis and the diagnosis of bipolar disorder (bd), of gut dysbiosis and mood relapses and of gut dysbiosis and cognitive impairment in bipolar patients.

a prospective longitudinal study will be carried out with three groups of patients: a group of euthymic bipolar i or ii patients without cognitive impairment (n=50), a second group of euthymic bipolar i or ii patients with cognitive impairment (n=50) and a control group of healthy volunteers (n=50). cognitive impairment will be defined as performance in any test of a domain below 2 standard deviations or more from the mean of normative data of each test assessed in the control group. subjects will be recruited in the hospital clinic of barcelona. at baseline clinical variables and diet patterns (rome iii) will be collected and neuropsychological performance (wcst, fas, stroop colour-word interference test, tmt, wais-iii, cvlt-ii) and functionality (fast) will be assessed. all subjects will be reassessed at 12 months follow-up. the mood state and possible affective relapses will be evaluated and treatments will be registered. all patients will receive standard psychiatric care according to international guidelines on bipolar disorders. fecal samples will be collected and then frozen in the morning pre-prandial after having fasted overnight. dna will be separated and stored at -80°c until assayed. sequencing will be performed on an illumina miseqtm platform. statistical analysis will be performed with the latest existing version of the spss.

Eligibility criteria:
inclusion criteria: * patients: * diagnosis of bipolar disorder type i or ii according to dsm-iv criteria (scid); * age between 18-55 years; * euthymia (ymrs\<6 and hmdrs\<8) for at least 3 months; * signed informed consent. * healthy controls: * no psychiatric diagnosis (scid); * age between 18-55 years; euthymia (ymrs\<6 and hmdrs\<8); * signed informed consent. exclusion criteria: * use of any type of antibiotics, antifungals or pro/prebiotics within at least one month prior to recruitment; * iq\<85; * neurological illness; * stomach/gut problems; * current diagnosis of substance abuse or dependence according to dsm-iv criteria (scid); * electroconvulsive therapy in the last year.
metabolomic study in huntington's disease (metabo-hd)

Conditions: Huntington Disease

Summary: the purpose of this project is to study huntington's disease by metabolomic approach.


Eligibility criteria:
inclusion criteria: for all groups: * age between 20 and 70 years * signature of the informed consent * covered by social security for presymptomatic group: * positive genetic test with cag repeat length ≥ 37 in htt gene * unified huntington disease rating scale ≤ 5 for symptomatic group: * positive genetic test with cag repeat length ≥ 37 in htt gene * the unified huntington's disease rating scale motor score ≥ 6 * the total functional capacity score ≥ 11 exclusion criteria for all groups: * participation in another therapeutic trial (3 months exclusion period) * pregnancy and breastfeeding * persons deprived of their liberty by judicial or administrative decision
investigating superion™ in spinal stenosis

Conditions: Lumbar Spinal Stenosis; Intermittent Claudication

Summary: the proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the superion™ iss compared to the x-stop® ipd® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care.

the proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the superion™ iss compared to the x-stop® ipd® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care. the study endpoint is the rate of overall subject success at 24 months.

Eligibility criteria:
inclusion criteria: * male or female subjects ≥ 45 years of age * persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion activities (example: sitting or bending over a shopping cart) * diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (sap), the posterior vertebral margin (lateral recess), and the nerve root canal (foraminal) * must be able to sit for 50 minutes without pain and to walk 50 feet or more exclusion criteria: * axial back pain only * fixed motor deficit * diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or experimental device * unremitting pain in any spinal position * significant peripheral neuropathy or acute denervation secondary to radiculopathy * lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention * significant instability of the lumbar spine as defined by 3mm translation or 5 degrees angulation * sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips * spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1 to 4) * spondylolysis (pars fracture) * morbid obesity, defined as body mass index (bmi) greater than 40kg/m2 * insulin-dependent diabetes mellitus * prior surgery of the lumbar spine * cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction) * infection in the disc or spine, past or present * paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease * tumor in the spine or a malignant tumor except for basal cell carcinoma * involved in pending litigation of the spine or worker's compensation related to the back
evaluation of a tele-rehabilitation service program

Conditions: Stroke; Paresis

Summary: is a unique tele-rehabilitation service directed at treating upper limb weakness due to stroke feasible to provide at mayo clinic and are the individuals with stroke and the clinicians providing the care satisfied with the process?

participants will be identified from mayo clinic division of brain rehabilitation's existing clinical practice and recruited either in person or by using a phone script. eligible participants will have 2 in-person clinical assessments, one before the intervention and one concluding the protocol. the first clinical assessment will involve introducing and familiarizing the participant with the study procedure, demonstrating and practicing with the system, and obtaining baseline clinical measures. during this first session the participant's technical skills and home equipment capabilities will be assessed and any assistance needed for establishing the technology in their home will be determined and provided. the second clinical assessment will include acquiring post-intervention clinical and outcome measures. intervention duration will be 3 months. during the study period, each participant will receive online treatment for up to 45 minutes (in order to have net 30 min clinical time) twice per week. during these sessions, the clinician will teach system interaction including integrating feedback, instruct in system intervention activities and assure participant competence in system use, and adjust the level of difficulty in each activity according to the participant's abilities and needs. after the first month of intervention, the participant may be given permission by the therapist to train with the system for no more than 40 minutes per day. such self-training opportunities are in addition to the twice weekly online sessions with the therapist.

Eligibility criteria:
inclusion * \>12 months after stroke * age 21-80 years * a minimum of 45 degrees of flexion in the affected shoulder * active extension of the affected elbow to 150 degrees * independent sitting balance * able to understand simple instructions * lives within a 100 mile radius and able to attend two clinical assessments at mayo clinic * able to install the tele-rehabilitation software with minimal remote technical support * available caregiver as needed who has basic technical understanding of computer operation * i3 processor based pc; 26" monitor; windows 7 or 8 operating system; internet connection of at least 10mbps. exclusion * medical conditions that may limit physical activity at the level of low intensity cardio-vascular exercise * any contraindication related to the integrity of the musculoskeletal system * active malignancy * uncontrolled epilepsy * global aphasia * severe apraxia * severe ataxia * unilateral spatial neglect * chronic pain * pregnancy * adults lacking capacity

Keywords: stroke remote monitoring hemiparesis
exposure to neurotoxins as risk factors for amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis; ALS

Summary: this study is a follow-up to an earlier study that examined the relationship of this study will examine whether exposure to neurotoxins, such as lead, mercury, solvents, and pesticides, can contribute to amyotrophic lateral sclerosis (als), also known as lou gehrig's disease. the cause of this degenerative disease of the brain and spinal cord is not well understood. some studies suggest that exposure to environmental neurotoxins may increase its risk. this follow-up study will examine the relationship of neurotoxin exposure to the interval between the diagnosis of als and death. it will also examine the possible roles of genetics, lifestyle and dietary factors in the disease. information on als patients previously enrolled in the study will be used to examine this relationship. no new individuals will be enrolled in the study.

objective: the objective of this proposal is linkage with the national death index (ndi) for cases from a study that was conducted in the early 1990's. the purpose of the initial study was to examine the role that lead and other exposures, including mercury and solvents, play in the etiology of amyotrophic lateral sclerosis (als). study population: the study involved 110 als cases and 256 population based controls, recruited in new england between 1993 and 1996. data collection involved an interview, blood collection, and measurement of bone lead using x-ray fluorescence. design and outcome parameters: the results of this study suggested that lead exposure was a risk factor for als. compared to controls, cases were more likely to have occupational lead exposure, and both blood and bone lead levels were higher in cases. we are presently analyzing data on other neurotoxic exposures including mercury, solvents, and pesticides. in order to investigate prognosis, we would like to determine the date of death by searching the national death index. this information will enable us to evaluate the relationship of neurotoxic exposures to als prognosis.

Eligibility criteria:
* inclusion criteria: the purpose of the ndi search will be to verify death and obtain date and cause of death information for the study participants.

Keywords: case-control study death certificates national death index cause of death information lead exposure amyotrophic lateral sclerosis als
automated assessment of mental health in the workplace

Conditions: Mental Disorders

Summary: the purpose of this study is to design, refine, and test for the effectiveness of a computer-based telephone system (telephone-linked communications for detection of mental health disorders in the workplace; tlc-detect) that will screen workers for mental health distress; educate them about seeking treatment; and follow up with them over a 6 month period.


Eligibility criteria:
inclusion criteria: * employment with benefits at boston medical center, boston university, or florida power and light company * ability to speak and understand conversational english * \> 18 years of age * access to a touch-tone telephone * screen positive for the world health organization (who)-5 well-being index exclusion criteria: * being under treatment (medication or therapy) for a mental health disorder * taking medication for a serious/major medical disorder that interferes with normal life * taking medication prescribed for mental health treatment on a daily basis * diagnosed with schizophrenia * planning to go on leave for over 6 months
the prone breast radiation therapy trial

Conditions: Ductal Carcinoma In Situ; Invasive Breast Cancer

Summary: participants undergoing radiation after breast conserving surgery for an early breast cancer (either ductal carcinoma in situ (dcis), or early stage invasive breast cancer), and are at increased risk of developing a skin reaction because of their large breast size. after breast conserving surgery (also known as a 'lumpectomy'), women with either dcis or early stage invasive breast cancer receive radiation to the breast to decrease the risk of cancer recurrence. breast radiation is usually done with women lying on their back ("supine"). some women develop temporary breakdown of the skin (moist desquamation). this skin reaction can be painful and has been linked to long term side effects such as chronic pain and decreased quality of life. this study is being done because women with large breasts have higher rates of skin breakdown (called 'moist desquamation') and breast pain during and shortly after radiation therapy is complete. it is unclear if such skin reactions and pain would be improved by alternating treatment position - namely lying on your belly ("prone") during their radiation treatment.

the risk of moist desquamation in large breasted women remains unacceptably high and reactions tends to be severe and produce significant permanent and delayed side effects. evidence suggests that the use of a prone breast imrt technique has the potential to decrease the risk of moist desquamation in large breasted women to the levels that are now seen when average/smaller breasted women are treated with supine imrt. as prone breast xrt is currently only offered at 6 of 15 of the ontario cancer centres polled for the purposes of providing motivation for this study, a multicentre rct is feasible to confirm and quantify the improvement provided by the prone technique and provide level 1 evidence for it to be adopted world-wide.

Eligibility criteria:
inclusion criteria: * confirmed histological diagnosis of breast carcinoma or ductal carcinoma in situ (dcis); * treated with bct; * no indication for treatment of regional ln; * women with a bra size of 40 inches or greater, or a pre-surgery cup size of d or greater exclusion criteria: * regional lymph node xrt indicated; * bilateral breast cancer; * unhealed wound (skin not closed and/or infection); * previous xrt to the same breast; * unable to lie prone; * presence of active connective tissue disease; * pregnancy; * unacceptable heart exposure (as measured by \> 10% of the heart receiving 50% of the prescribed dose, i.e. v25gy \> 10%); * adequate coverage of postoperative tumour bed not technically possible

Keywords: dcis early stage invasive breast cancer prone breast radiotherapy
defining the radiotherapy dose and volume parameters affecting postoperative complications in esophageal cancer patients

Conditions: Esophageal Cancer

Summary: the purpose of this study is to identify features of the cumulative dose-volume histogram (dvh) for patients treated with trimodality therapy in oesophageal cancer and correlate these with postoperative complications.

intention to treat analysis in patients initially assigned to be treated with the trimodality protocol: neoadjuvant chemoradiotherapy followed by surgery. the investigators will retrospectively evaluate several parameters of the treatment planning of patients treated with a preoperative regimen (cross regimen 41,4 gy in 23 fractions or 50, 4 gy in 28 fractions ): * ptv volume1 * mld, v30, v20, v15, v10, vs5 (volume lung less dan 5 gy)2 (lung toxicity) * mhd, v20, v30, v403 (heart toxicity) * mean stomach dose, v50 stomach * mitochondrial dna if available per patient pre-existing cardiac,pulmonary comorbidity, smoking behavior, bmi, type of surgery and chemotherapy (especially taxanes) will be scored and take into account in a multivariate analysis. the investigators will collect these data and correlate the data with the presence of postoperative complications, time of onset of complications and duration of hospitalization. these latter data are already scored in a prospective manner at the atrium medical center in heerlen.

Eligibility criteria:
inclusion criteria: * oesophageal cancer patients * initially treated with a preoperative dose of radiation in combination with chemotherapy and subsequently undergone surgical resection exclusion criteria: * patients who were treated with definitive chemoradiation or palliative radiotherapy