Kornimate/medical-research-clean huggingface dataset:
analysis of cutaneous nerve biopsies in gastrointestinal motility disorders

Conditions: Small Fiber Neuropathy; Gastrointestinal Dysmotility

Summary: this study is being done to evaluate cutaneous nerve biopsies from patients with refractory gastrointestinal motility disorders. the purpose of the study is to evaluate skin biopsies for signs of small fiber neuropathy in gi dysmotility patients, which may provide a better understanding of the underlying pathology of their condition. specifically, identifying any small fiber neuropathy that may exist in the peripheral nervous system may help us to better understand the mechanism of presumed enteric neuropathy that may be involved in causing gi dysmotility.

1. gather basic, clinical information and perform small 3-6mm skin biopsies. 2. identify characteristics of epidermal nerve fibers in patients with symptoms of gastrointestinal dysmotility 3. to isolate skin-derived precursor cells from skin biopsies and test their ability to generate neurons in vitro and in immune-deficient mouse models.

Eligibility criteria:
inclusion criteria: * individual with a gastrointestinal motility disorder that has failed both clinical and surgical options for symptomatic management exclusion criteria: * child 17 years of age or younger * individuals incapable of informed consent * patient with diseased skin or on drugs which affect skin biology.
treatment of locally advanced non-small cell lung cancer (nsclc)

Conditions: Locally Advanced Non-small Cell Lung Cancer

Summary: the purpose of this study is to determine the maximum tolerated dose of the combination of vorinostat, cisplatin, pemetrexed, and radiation therapy in patients with unresectable stage iiia/iiib non-small cell lung cancer.

this phase i trial will escalate doses of the histone deacetylase inhibitor (hdac) vorinostat to a chemoradiation platform for cisplatin, pemetrexed and radiation to a dose of 70gy in nsclc patients with unresectable iiia and dry iiib disease. the endpoint will be to determine mtd of the combination.

Eligibility criteria:
inclusion criteria: * biopsy proven non-squamous nsclc with unresectable stage iiia or dry iiib disease. * fev1 \>/= 1 liter * ecog ps 0 or 1 * able to swallow and absorb enterally * measurable disease per recist 1.1 * adequate organ and marrow function including calculated creatinine clearance \>/= 60 ml/min hepatic enzymes and alk phos \</= 2.5 x uln. exclusion criteria: * chemotherapy or radiotherapy \</= 4 weeks prior to registration (6 weeks for nitrosureas) * active bleeding * known brain mets * prior thoracic radiotherapy that would lead to overlap with current radiation field. * more than 10% weight loss in 6 months. * pancoast tumors, supraclavicular or contralateral hilar lymph node involvement * known hiv positive * prior treatment with an hdac inhibitor

Keywords: lung cancer locally advanced lung cancer
effects of hydrocortison treatment on angiotensin ii and angiotensin ii receptors in patients with septic shock

Conditions: Shock, Septic

Summary: this study aims to evaluate the role of angiotensin ii, at1, and at2 on catecholomine responsive and catecholomine resistant septic shock, and the effect of hydrocortisone traetment on catecholomine resistant septic shock and angiotensin ii, at1, and at2.angiotensin ii can be used as a biomarker of vasoplegia observed in refractory septic shock unresponsive to catecholamine. in these patients; therapeutic effect of hydrocortisone on hypotension was performed by decreasing at 2 level, at2 should be investigated as a therapeutic target in the treatment of vasoplegia-induced hypotension and svri measured by minimally invasive cardiac output method suggests that it can be used as a useful parameter in the diagnosis and follow-up of vasoplegia.

this study will be enrolled 40 patients diagnosed with septic shock according to sepsis 3 criteria. the patients with septic shock who needed a noradrenaline infusion rate of up to 0.5µg/kg/min to maintain map\>65 mmhg will be classified as control group (n=20) and the ones who required a noradrenaline infusion rate above 0.5µg/kg will be classified as hydrocortisone group (n=20). blood samples will be taken for analysis of plasma angiotensin ii, at1, at2 levels at the time of diagnosis, one hour after and on the 3rd day of the bundle and the hydrocortisone treatment. hemodynamic parameters simultaneously obtain by continuous minimal invasive cardiac output measurement method will record.

Eligibility criteria:
inclusion criteria: * septic shock patient exclusion criteria: * other causes of end-stage organ failure, immunodeficiency, presence of acute mesenteric ischemia, vasospastic disease, pregnancy, other shock causes (hypovolemic, cardiogenic, neurogenic), life expectancy less than 48 hours corticosteroid use in the last 4 weeks

Keywords: shock, septic hydrocortisone angiotensin ii
evaluation of the influence of food regimen on oshadi d absorption

Conditions: Lupus Erythematosus, Systemic

Summary: the study will be a non-randomized, open label, single dose, placebo control, single center, and single arm study in healthy subjects. the study will include one administration of placebo and four single administrations of oshadi d in two different dose levels, administered in two feeding regimen for the evaluation of the influence of food on oshadi d absorption.


Eligibility criteria:
inclusion criteria: * healthy male/female 21 years old and up. * subject must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements. * subject must be sterile or infertile or use an approved method of contraception from the time that the first dose of study medication is taken until three months following study completion or discontinuation. exclusion criteria: * any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results. * subject with positive hiv serology or positive hbsag at screening. * history or evidence of any active liver disease. * female subject who are breastfeeding or have a positive pregnancy test at screening or at any time during the study. * inability to give written informed consent * history of alcohol or drug abuse within 6 months of screening. * subject who have a positive urine drug screen for substances of abuse (benzodiazepine, thc, opiates, amphetamines, cocaine) at the screening. * mental disorders. * subject with poor venous access * significant swallowing disorders * digestive disorders; * small bowel surgery; * mall absorption disorders.

Keywords: lupus
observational study of anti-cancer therapy induced oral mucositis in korean cancer patients

Conditions: Oral Mucositis

Summary: to survey oral mucositis after chemotherapy and concurrent chemoradiotherapy in korean cancer patients


Eligibility criteria:
inclusion criteria: * patients diagnosed with one cancer among head and neck cancer, esophageal cancer, breast cancer, colorectal cancer, gastric cancer, and non-small cell lung cancer, who are being treated or going to be treated as one between a and b a. chemotherapy only b. concurrent chemoradiotherapy exclusion criteria: * patients who are pregnant or breast feeding, absent from effective(medically proven) contraceptive method for females of childbearing potential * patients with performance status of ecog score is more than 3
spinal cord stimulation to shorten ventilator dependence in ards patients

Conditions: Respiratory Distress Syndrome

Summary: this is an early phase, proof-of-concept clinical trial assessing the safety and feasibility of non-invasive spinal cord stimulation to prevent respiratory muscle atrophy in mechanically ventilated ards patients. the investigators will recruit 10 elective surgery patients (surgery cohort) and 10 ards patients (ards cohort) for this study. a non-invasive, alpha-prototype restore technology stimulator using hydrogel surface electrodes will be used to stimulate the spinal cord at the cervical or thoracic level.

stimulation will be conducted in closed-loop fashion at the start of inspiratory cycle. signal from a chest belt will be used to synchronize stimulation with ventilator and prevent interference with ventilator (see protection of human subjects). prior to treatment stimulation, mapping will be conducted at 1 hz with electrodes placed in locations identified to be optimal in the surgery cohort. assessment of evoked emg responses from respiratory muscles will be conducted. once this electrode configuration is confirmed as effective (capable of evoking emg activity), stimulation with this configuration will be applied for treatment.

Eligibility criteria:
inclusion criteria: 1. male or female 18-85 years; 2. intubated with confirmed diagnosis of ards (by berlin criteria: acute onset within one week of known insult, bilateral airspace opacities not fully explained by pleural effusions, atelectasis, and/or nodules, respiratory failure not explained by heart failure or fluid overload, pao2/fio2 ratio \< 300); or identified as a patient admitted to the intensive care unit (icu) after non-cardiac surgery; 3. able to provide informed consent or available next of kin able to provide informed consent; 4. have intact chest/lung, upper and lower extremity anatomy; 5. the neuromuscular connections between the spinal cord, diaphragm, and intercostal muscles are intact; 6. enrollment of subject within 48 hours of intubation; 7. able to induce evoked response of diaphragm muscle by spinal cord tes. exclusion criteria: 1. phrenic nerve or diaphragm pacer; 2. history of seizure disorder or on anti-epileptic medication for the treatment of seizures; 3. compromised skin in back (neck, upper and lower back); 4. pregnancy; 5. implanted devices: cardiac pacemakers, implanted defibrillators, implanted neurostimulators, phrenic nerve pacers; 6. bmi greater than or equal to 35; 7. pharmacological paralysis/neuromuscular blockade\*.

Keywords: respiratory distress syndrome
effect of ulnar styloid fracture on the outcome of distal radial fractures treated with external fixation

Conditions: Fracture of Distal End of Radius; Fracture of Ulnar Styloid

Summary: untreated ulnar styloid fracture may affect the outcomes of distal radial fracture patient treated with external fixation.


Eligibility criteria:
inclusion criteria: * unstable distal radial fracture * fixed with external fixator exclusion criteria: * multiple fracture * open fracture * nerve injury * vascular injury
exercise prescriptions for patients with cardiovascular disease

Conditions: Cardiovascular Diseases

Summary: physiotherapists are often confronted with patients with (elevated risk for) cardiovascular disease (cvd), even when this is not the primary indication for physiotherapy. hence, physiotherapists should be able to provide evidence-based exercise advice to these patients, but this has not been assessed. the aim of this study was therefore to assess whether exercise prescriptions by physiotherapists to patients with cvd are in accordance with international recommendations.

in this prospective observational survey, forty-seven belgian physiotherapists agreed to prescribe exercise intensity, frequency, session duration, program duration, and exercise type (endurance or strength training) for the same three patient cases. exercise prescriptions were compared between clinicians and relations with clinician characteristics were studied. in addition, the agreement between physiotherapists' exercise prescriptions and those from international recommendations (based on a maximal score of 60/per case) was assessed.

Eligibility criteria:
inclusion criteria: currently professionally active flemish physiotherapists exclusion criteria: not having access to a device that allows the use of the exercise prescription in everyday practice \& rehabilitative training (expert) tool.

Keywords: physiotherapy exercise prescription cardiovascular disease
extracellular vesicles as potential biomarkers and therapeutic target in gaucher disease

Conditions: Gaucher Disease

Summary: this is an observational study intended to generate preliminary data to understand how lysosomal dysfunction can affect the biogenesis of extracellular vesicles, its content and function. the primary objective of the proposed project is to decipher how extracellular vesicle (ev) biogenesis and its role in intercellular communication can be impaired as a consequence of defects in lysosomal function. collectively these defects in ev biogenesis and function can contribute to the neuroinflammation observed in lysosomal storage diseases. since evs can cross the blood-brain barrier, their characterization may be valuable in identifying novel biomarkers. in the presence of a gba1 mutation, the decrease in gcase activity will lower overall lysosome function and increase the secretion of evs. further, there will be differences in ev size, its cargo including lipids, rna and proteins and their aggregates. in comparison to healthy controls, evs isolated from patients with gaucher disease (gd) and gba1 carriers is hypothesized to show significant differences in terms of its characteristics and content, which can contribute to our understanding of the link between lysosomes and neurological disease.


Eligibility criteria:
inclusion criteria: * age between 18-80yrs * restricted to participants who are untreated, obligate carriers and healthy controls. * participants with gd should have confirmed gd diagnosis, mutation confirmed for carriers and healthy controls confirmed to have no gba1 mutation by gene sequencing. exclusion criteria: * exclude participants who have any hematological malignancy or other uncontrolled comorbid conditions. * exclude participants who are currently on therapy for their gd * exclude participants who have any hematological malignancy or other uncontrolled comorbid conditions.
comparative study between hormonal and hysteroscopic management of cesarean scar defect

Conditions: Cesarean Scar Defect

Summary: up to 70% of women who have had a previous caesarean section experience uterine niche, with 30% having symptoms. prevalence rates vary between 24-70% using transvaginal ultrasonography and 56-84% using gel/saline instillation sonohysterography. classification involves the ratio of myometrial thickness at the scar to adjacent myometrium, with severe deficiency defined by a ratio of ≤50%. dehiscence is defined as at least 80% myometrial thinning. the aim of this work was to compare between the effectiveness of two different techniques of hysteroscopic ablation of cesarean scar defect and hormonal treatment to improve abnormal uterine bleeding and pelvic pain localized in the suprapubic area associated with isthmocele.

the study include 78 women diagnosed with abnormal uterine bleeding (aub). all cases were subjected for complete history taking, complete general and gynaecological examination, vaginal ultrasonography (tvus) to confirm niche and exclude other pathologies. the women were randomly divided by1:1:1 ratio into three equal groups using double blind method with closed envelopes group a: include 26 patients subjected to hysteroscopic surgery in the form of resection of lower edge, resection of upper edge and endocoagulation to fulgurate the visible dilated blood vessels or endometrial-like glands inside the base of the niche by using a roller ball resectoscope with monopolar electrical current and glycine as distension media. group b: include 26 patients subjected to hysteroscopic endocoagulation to the base of the niche by roller ball using monopolar electrical current and glycine as distension media. group c: include 26 patients received hormonal treatment in the form of 3rd generation combined oral contraceptive pills in a cyclic manner for 6 months. follow up was done after 1, 3, 6 months, by tvus to exclude presence of symptoms of abnormal uterine bleeding (aub) and to assess different outcome measures including presence or absence of intermenstrual spotting, presence or absence of postcoital bleeding, presence or absence of pelvic tenderness or dyspareunia

Eligibility criteria:
inclusion criteria: * women with age ranging from 25 to 42 years, * previous cesarean section, * presence of a cesarean scar defect on ultrasound with a residual myo3metrium of \> 1.5 mm. exclusion criteria: * any contraindications of hysteroscopy as an active pelvic infection, active genital herpes, * contraindications to hormonal treatment as medical conditions like breast cancer, history of deep venous thrombosis, previous arterial thrombosis, pulmonary embolism, active liver disease, use of rifampicin, familial hyperlipidemia, pregnancy, * patient refusal * any other causes of abnormal uterine bleeding as polyp, adenomyosis. leiomyoma, malignancy, coagulopathy. and ovulatory disorders.

Keywords: cesarean scar defect hormonal treatment hysterscopic treatment endocoagulation hysteroscopic resection
observational trial of the longitudinal effects of cftr modulator drugs

Conditions: Cystic Fibrosis

Summary: cf patients enrolled in this protocol will be recruited from patients followed by the adult cf program at national jewish health. patients will be selected based on planned use of a cftr modulator by their primary physician. no patient will be started on (or will switch) cftr modulator agents for the purpose of the study. after enrollment, biological samples may be collected at two different time points prior to treatment initiation. one set of samples will be collected at baseline health prior to cftr modulator initiation or change. a second set of samples will be obtained in subjects at the time of acute pulmonary exacerbation, if one occurs prior to cftr modulator initiation or change. post cftr modulator initiation study assessments will be obtained at least one month after starting treatment and continue up to 2 times a year (including during pulmonary exacerbations), in order to document longitudinal effects of therapies and changes in inflammatory biology over time. at the time of each biological sampling, blood, sputum sample, urine, and a quality of life assessment will be acquired in all enrolled subjects. in addition to demographic data, clinical data, such as quantitative microbiology and simple spirometry will be recorded at the time of sample collection.


Eligibility criteria:
inclusion criteria: * documented diagnosis of cf with an eligible mutation for modulator treatment. * age 18 years old or older. * patient is starting a cftr modulator as part of their clinical care or switching cftr modulator therapy agents, pending fda approval. * ability to perform reproducible pulmonary function tests. * willingness to comply with study procedure and willingness to provide written consent. exclusion criteria: • presence of a condition or abnormality that, in the opinion of the principal investigator (pi), would compromise the safety of the patient or the quality of the data.
comparison of clinical efficacy of liver resection, rfa, tace, and drug therapy in patients with gist lm

Conditions: GIST, Malignant; Liver Metastases

Summary: the goal of this observational study is to evaluate the overall survival benefits of local treatment combined with imatinib(im) and im alone in patients suffering from gist liver metastases. the main question it aims to answer is: • whether im combined with hepatic resection (hr) or other local treatments such as radiofrequency ablation (rfa) and transarterial chemoembolization (tace) has better long-term survival benefits compared to im monotherapy. patients are divided into different treatment groups: * im group * im combined with hr group * im combined with rfa or tace group researchers will compare the im + hr group and im + rfa/tace group with the im group to see if it has a better overall survival (os).

gastrointestinal stromal tumors (gists) represent the most prevalent type of mesenchymal tumor within the gastrointestinal tract, and the liver is the most common site of metastasis from gist. imatinib (im) has significantly enhanced clinical outcomes for patients with advanced disease. since its approval in february 2002 for treating metastatic or unresectable gists, 38% of patients have shown a partial response, while 13.6% have experienced disease progression within 1 to 3 months of im administration. over half of the patients with metastases experienced disease progression within two years of im treatment, attributed to secondary drug resistance. few studies are comparing the survival benefits of different surgical modalities. the investigators aimed to evaluate im combined with hepatic resection (hr) or other local treatments such as radiofrequency ablation (rfa) and transarterial chemoembolization (tace), compared to im monotherapy in long-term survival benefits in patients suffering from gist liver metastases.

Eligibility criteria:
inclusion criteria: * pathological evidence of gist of primary tumors * liver metastases evidenced by biopsy or radiological findings * sufficient liver, hematologic, and renal function, coupled with an eastern cooperative oncology group performance status score ranging from 0 to 1 exclusion criteria: * im was not used during treatment * liver metastases appeared on second-line or later subsequent lines of tki * combined with other malignant tumors * failure to follow up
sarcothal. thalidomide in skin sarcoidosis

Conditions: Sarcoidosis

Summary: sarcoidosis is a multisystem disease involving most frequently the lung, the eyes, the lymph nodes and the skin. skin lesions may be disfiguring and impair the quality of life. thalidomide is a multi-target drug that has been shown to be of benefit in skin sarcoidosis in case reports. the objective is to assess the efficacy and tolerance of thalidomide in skin sarcoidosis.

the study consists in comparing thalidomide to placebo in skin sarcoidosis. patients with sarcoidosis not necessitating a high-dose corticosteroid regimen, and assessable skin lesions, are eligible. they are randomized and receive either thalidomide or placebo for 3 months. then they are given thalidomide for a 3-month open-label period.

Eligibility criteria:
inclusion criteria: * biopsy proven skin sarcoidosis * assessable target skin lesions exclusion criteria: * rapidly evolving sarcoidosis * patients necessitating a corticosteroid regimen of more than 15mg per day. * women not willing to undertake a contraceptive method. * neurologic impairment * past treatment with thalidomide * renal impairment

Keywords: randomized controlled trial thalidomide vs placebo skin sarcoidosis thalidomide