Kornimate/medical-research-clean huggingface dataset:
a study of diazoxide choline in patients with prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: the purpose of this is study is to evaluate the effects of dccr (diazoxide choline controlled release tablets) in children and adults with prader-willi syndrome.


Eligibility criteria:
inclusion criteria: * provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (patients, as appropriate) * genetically-confirmed prader-willi syndrome and hyperphagic * in a stable care setting for at least 6 months prior to visit 1 * caregiver must have been caring for the patient for at least 6 months prior to visit 1 exclusion criteria: * have participated in an interventional clinical study (i.e., investigational drug or device, approved drugs or device evaluated for unapproved use) within prior 3 months * positive urine pregnancy test (in females of child-bearing potential) or females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation * any other known disease and/or condition, which would prevent, in the opinion of the investigator, the patient from completing all study visits and assessments required by the protocol

Keywords: pws prader-willi syndrome
early diagnosis of diabetes mellitus in patients with cystic fibrosis

Conditions: Cystic Fibrosis; Diabetes Mellitus

Summary: is oral therapy with repaglinide equivalent to insulin therapy with three daily injections with respect to blood glucose control, weight and pulmonary function over 2 years in patients with cystic fibrosis and secondary diabetes mellitus? that is the question examined in the phase iii trial.

diabetes mellitus may be present in patients with cystic fibrosis (mucoviscidosis) starting in the second decade of life. the prevalence increases rapidly with increasing age. as life-expectancy increases in cf, cf-related diabetes will be diagnosed more frequently in the future. negative consequences of secondary diabetes in cystic fibrosis include: * catabolic metabolism * weight loss * more frequent / more severe infections * deterioration of pulmonary function * reduced life-expectancy * diabetic micro vascular complications (retinopathy, nephropathy, neuropathy) up to date, no data are available to answer the question, whether secondary diabetes in cf should always be treated by insulin therapy. several centres report the successful management of cf-related diabetes using oral anti-diabetic drugs at least for some years. oral therapies would be less invasive for a patient group which is highly traumatised by a very demanding therapy (multiple drugs including antibiotics, pancreas enzymes, bronchodilators, mucolysis, in addition to physiotherapy, regular inpatient iv-antibiotic therapy etc, finally lung transplants in a subgroup of patients).

Eligibility criteria:
inclusion criteria: inclusion criteria for the screening: * diagnosed cystic fibrosis * age 10 years and older inclusion criteria for the therapeutic part of the study: * newly diagnosed diabetes mellitus in the screening exclusion criteria: exclusion criteria for screening: * diabetic keto-acidosis (blood glucose \> 350 mg/dl and arterial ph \< 7.25) * already treated diabetes mellitus by oral antidiabetic medication or insulin exclusion criteria for the therapeutic part of the study: * systemic steroid therapy during the last 3 months * transplantation (status post tx or on the waiting list for tx) * beginning pulmonary insufficiency, fev1 \< 35% at pulmonary function test in stable condition * pregnancy * already diagnosed and treated diabetes mellitus * patients with diabetic keto-acidosis (blood glucose \> 350 mg/dl and arterial ph \< 7.25) with or without diabetic coma * severe liver insufficiency (chronic hepatitis b, ast or alt twice the upper limit of normal, quick's value \< 70% which is a contraindication to use repaglinide) * treatment with an indispensable important drug which contraindicates repaglinide * peg/ gastric tube/ total parenteral alimentation for more than 4 weeks during the study * cf-patients with type 1 diabetes * not patient's consent to randomisation and therapeutic trial * participation on other medical trial
serologic markers for inflammatory bowel disease during clinical forms with weak or strong evolution capacities

Conditions: Inflammatory Bowel Diseases

Summary: factors forecast chronic inflammatory bowel diseases (ibd) remain at present essentially on clinical factors (extension of the disease, achievement of the perianal ring, requirement of surgery, treatment by immunomodulators...). all ibd specific immunological or serological markers showed only a diagnostic role for indefinite colitis (hemorrhagic rectocolitis vs crohn disease) but were never able to be considered as predictive elements of adults ibd evolution. among the most used, the presence of anca's antibody and asca allows to separate hemorrhagic rectocolitis (anca + / asca-) from crohn disease (anca-/asca +) and their combination present an average sensibility about 85 % and a 85 % specificity. however, 8 other antibody types were recently isolated and estimated individually during ibd in particular during child crohn diseases (anti-ompc, anti-i2, anti-cbir1, anti-glycans (alca, amca and acca) anti-goblet cells and albicans candida's specific anti-mannan). these complementary assays improve significantly the reliability of the diagnosis. however, if the use of these new markers has an indisputable diagnostic role, their predictive role in the evolution of ibd was estimated at the adult's only rarely during crohn diseases. consequently, the investigators suggest realizing an exhaustive analysis of all these new immunological markers to define, if their association can have an interest in the differentiation of stable (or little evolutionary) and unstable (or quickly evolutionary) clinical forms.


Eligibility criteria:
inclusion criteria: * major patient * ibd (rch or mc) diagnosed according to the clinical, endoscopic and histological criteria * accepting the sampling of blood * patient member or legal successor of a national insurance scheme * taken care medical in the service of gastroenterology of chu de saint etienne * patient having signed the form of consent exclusion criteria: * minor patient or uncapable * patient suffering from indefinite colitis * refusal of the sampling of blood * pregnant woman * incapacity or refusal to sign the consent writes * subjects deprived of freedom by a court or administrative order * use of an anti-tnf. according to the indications ensuing from the sonic trial or from the strategy " top down ".

Keywords: chronic inflammatory bowel diseases crohn disease hemorrhagic rectocolitis immunological markers serological markers anca asca
costs of lost productive time among korean workers with panic disorder and effect of treatment with paroxetine controlled release

Conditions: Panic Disorder

Summary: panic disorder(pd)is a disabling psychiatric condition associated with significant impairment in psychosocial, occupational functioning and quality of life, as mentioned by mogotsi et al. so, most patients with panic disorder suffers from the consequences of the impairment in occupational function. this impairment is not only individual problem, but also social one. since productivity is very important item required to employees, lost productive time among workers with psychiatric illness should be reduced by the proper management. but few data were reported in this field by now.


Eligibility criteria:
inclusion criteria: 1. male or female outpatients aged 20-50 years 2. in female, is eligible to enter this study if she is if * non-childbearing potential(note:women who are 6 months post-menopausal are not considered women of child-bearing potential) * child-bearing potential, has a negative urine dipstick pregnancy test, and is practicing a clinically acceptable method of contraception such as oral contraception, surgical sterilization, i.u.d.,systemic contraception, or double barrier contraception(any two of diaphragm/spermicidal foar/condom) 3. subject currently meets the diagnosis for pd according to korean version of anxiety disorder interview schedule for dsm-iv(adis-iv) through a comprehensive psychiatric evaluation and not being treated currently. 4. subject must have the ability to comprehend the key components of the consent form and provide informed consent. exclusion criteria: 1. subject who has a history of any other major medical or psychiatric illnesses except pd or pd with major depressive disorder. 2. subject who retired or left his job or who plan to retire within two years. 3. is a current homicidal or suicidal risk in the investigator's judgement. 4. is currently pregnant, lactating or planning to become pregnant within the next 3 months 5. is currently participating in any other clinical trial or taking any non-approved or experimental medication.

Keywords: panic disorder (pd)
effects of glucocorticoid combined with vitamin c and vitamin b1 on microcirculation in severe septic shock

Conditions: Septic Shock

Summary: this study aimed to investigate the effect of glucocorticoid combined with vitamin c and vitamin b1 versus hydrocortisone alone on microcirculation in septic shock patients.

this prospective, double-blind, randomized, controlled trial enrolled septic shock patients admitted to the intensive care unite of a tertiary teaching hospital. we randomly assigned the enrolled patients to the treatment group (hydrocortisone combined with vitamin c and vitamin b1 added to standard care) and the control group (hydrocortisone alone added to standard care) in a 1:1 ratio. the primary outcome was perfusion vascular density (pvd) at 24 hours after treatment. we used the sublingual microcirculation imaging system to monitor pvd. we further validated the primary outcome by observing differences in renal perfusion monitored by renal contrast-enhanced ultrasound (ceus) between the treatment group and the control group.

Eligibility criteria:
inclusion criteria: 1. septic shock 2. a dose of norepinephrine (\>15ug/min) 3. age ≥18 and ≤80 years old 4. signing informed consent exclusion criteria: 1. meet the inclusion criteria for more than 12 hours 2. clinician judges that corticosteroid therapy should not be used 3. pregnant 4. uncontrolled malignancy 5. glucocorticoid therapy was used within seven days before admission. 6. expected death within 24 hours 7. the sublingual microcirculation cannot be measured

Keywords: septic shock glucocorticoid vitamin c microcirculation vitamin b1
cellulite and extracorporeal shock wave

Conditions: Cellulite; Microcirculation

Summary: hypothesis: the combination of extracorporeal shockwave and a daily gluteal muscle strength programme is superior to the gluteal muscle strength programme alone in cellulite. study design: randomized-controlled trial analysis: intention-to-treat outcome parameters: a) photo, b) nürnberger score, c) circumference measurements, d) capillary blood flow, e) tissue oxygen saturation, f) postcapillary venous blood flow intervention: extracorporeal shock wave for six sessions with 2000 impulses at both gluteal and thigh regions plus a specific gluteal strength exercise training follow-up: 12 weeks


Eligibility criteria:
inclusion criteria: females ages 18-65yrs cellulite 1°-4° informed consent exclusion criteria: pregnancy open wounds females \>18yrs or \>65yrs -

Keywords: cellulite; shockwave; microcirculation; skin
a retrospective study of toxicity and outcome of high dose chemotherapy with autologous stem cell transplant in patients with hodgkin lymphoma (hl).

Conditions: Hodgkin Lymphoma

Summary: the majority of patients with hodgkin lymphoma (hl)are cured with radiation therapy and/or combination chemotherapy. however, patients who relapse after attaining a complete remission with chemotherapy and those with primary refractory disease have a poor outcome with conventional chemotherapy regimens. treatment results with standard-dose second-line regimens produce low complete remission rates and minimal survival benefit. single institution studies have shown better outcome after autologous stem cell transplant in this group of patients when compared to historical controls receiving conventional treatment. in this retrospective review, we aim to analyze outcome and determine independent prognostic factors which would correlate with the long-term outcome of patients with hl who received an autologous stem cell transplant in the past at the royal marsden hospital eligible patients (those on current-follow-up) identified from the transplant database will be eligible for the study. accrual of eligible patients currently under follow-up will be performed in clinic at the time of next appointment. all patients accrued will give informed consent to participate in the study for retrospective case note review, after discussion with a study investigator and after receiving a study information sheet. the results of the analysis will be published in a peer-reviewed medical journal.


Eligibility criteria:
inclusion criteria: * a) age over 18 b) patients with hodgkin lymphoma who have received an autologous stem cell transplant c) informed written consent exclusion criteria: * a) medical or psychiatric conditions that compromise the patient's ability to give informed consent b) hiv positive or aids related lymphoma
right ventricular dysfunction in cardiac surgery patients

Conditions: Right Ventricular Dysfunction

Summary: to establish the correlation between echocardiographic parameters of the rv, measured with tee and the right ventricular ejection fraction (thermodilution). to identify a time in the perioperative process when rv dysfunction occurs.

measurements with echocardiography were done during cardiac surgery to observe the right ventricular dysfunction in the perioperative process

Eligibility criteria:
inclusion criteria: * cardiac surgery patients * elective, isolated aortic valve replacement or coronary artery bypass grafting in combination with aortic valve replacement exclusion criteria: * age \< 18

Keywords: cardiac surgery transoesophageal echocardiography
prophylactic or preemptive entecavir in patients with colorectal cancer who are inactive hepatitis b carriers

Conditions: Colorectal Neoplasms

Summary: there has been no report on whether the patients with colorectal cancer who are also inactive hepatitis b carriers should receive prophylactic use or preemptive use of an anti-viral drug entecavir. this open, randomized controlled clinical trial aims to compare the impact of the prophylactic use or preemptive use of an anti-viral drug entecavir on the outcomes of patients with colorectal cancer who are also inactive hepatitis b carriers during chemotherapy and the subsequent follow-ups.


Eligibility criteria:
inclusion criteria: 1. patients with age between 18 and 75 2. patient with histology-proven colorectal adenocarcinoma. 3. patients with eastern cooperative oncology group performance status (ecog) of 0-1 4. patients planned for at least 4 cycles of cytotoxic chemotherapy (either as part of curative therapy or as palliative therapy) 5. patients with at least 6 months' life expectancy from date of recruitment 6. patients with positive hepatitis b surface-antigen (hbsag) 7. patients with normal liver function tests including alanine aminotransferase (alt), aspartate aminotransferase alkaline (ast), phosphatase (alp), gamma glutamyl-transpeptidase (ggt), and bilirubin 8. patients with negative hbv-dna 9. patients with no known history of radiological \&/or histological diagnosis of chronic active hepatitis or cirrhosis of any cause, or history of prior hepatitis b reactivation, or prior chronic therapy for hbv within 6 months 10. patients with no evidence of autoimmune hepatitis, hepatitis c or d virus infection, hiv infection or radiological evidence of liver metastasis 11. adequate bone marrow, hepatic, and renal function within 14 days before recruitment 12. patients who sign the informed consent 13. patients with good compliance during chemotherapy and follow-ups exclusion criteria: 1. patients planned for radiation or radionuclide therapy 2. pregnant female patients 3. patients with a history of psychiatric drugs abuse and can't quit or with a mental disorder 4. patients with immunodeficiency, other congenital or acquired immunodeficiency, or transplantation history 5. according to the investigators' judgment, patients with concomitant disease that seriously harms patients' safety or the completion of study.

Keywords: colorectal cancer entecavir hepatitis b carrier
impact of vitamin d3 supplementation in non-sjogren dry eye patients with low serum vitamin d level

Conditions: Dry Eye Syndromes; Hypovitaminosis D

Summary: dry eye disease is multifactorial, ocular inflammatory condition causing irritation, stinging sensation, uneasiness and blurring. non-sjogren syndrome occurs due to absent or dysfunction of lacrimal gland. fat soluble vitamin d act as an agent against inflammation and its deficiency may result in various inflammatory diseases including dry eye. purpose of this study is evaluation of vitamin d3 supplementation role in treating non-sjogren dry eye along with conventional treatment by using artificial tears in patients with hypovitaminosis d. a prospective study was conducted in rural health center(rhc) buchal kalan on 108 patients presenting with non-sjogren dry eyes and low serum vitamin d levels. patients were subjected to the following examination; best corrected visual acuity (bcva), slit-lamp examination, applanation tonometry, fundoscopy, tear breakup time (tbut) after fluorescein staining, schirmer tear test, numerical pain rating scale (nprs) and ocular surface disease index (osdi) score on day 0, 15, 30, 60 and 90. vitamin d levels was assessed by electrochemiluminescence immunoassay (eclia) based analyzer. the sample was randomly divided into two groups by non-probability purposive sampling. group 1 received only artificial tears 4times/day while group 2 were given oral vitamin d3 supplementation of 6000 international unit (iu) daily along with artificial tears. impact of oral vitamin d3 supplementation on non-sjogren dry eyes was assessed by comparing means of ocular parameters of both groups over different period of time by using mann-whitney test and friedman test.


Eligibility criteria:
inclusion criteria: * patients with non-sjogren dry eyes with low serum vitamin d level. * both gender. * age group will be 20-50 years of age. * cooperative patients. exclusion criteria: * autoimmune diseases (such as sjogren syndrome and lupus syndrome). * all ocular pathologies except dry eyes. * all systemic pathologies that affects tear layers. * all non- cooperative patients.

Keywords: artificial tears. dry eye syndrome. vitamin d deficiency.
phase 1 study to test the bioequivalence between two 25 mg tablets vs. one 50 mg tablet under fast/fed condition and evaluate food effect of desvenlafaxine succinate sustained release (dvs sr)

Conditions: Depression - Major Depressive Disorder

Summary: to determine the bioequivalence of 2 tablets of 25 mg sustained release (sr) formulation of dvs and 1 tablet of 50 mg sr formulation of dvs under fed and fast conditions. to investigate the effect of high-fat meal on pharmacokinetics of desvenlafaxine after administration of 50 mg sr formulation of dvs.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease

Keywords: dvs sr healthy bioequivalence study
single versus double injection costoclavicular block

Conditions: Upper Extremity Injury

Summary: in this trial, the objective is to compare single- and double-injection ultrasound-guided costoclavicular blocks. the rationale behind this idea is that a second local anesthetic injection, inside the costoclavicular space, may compensate for the dynamic cord dispersion seen with the single-injection technique. thus the research hypothesis is that, compared to its single-injection counterpart, a double injection costoclavicular block will result in a shorter onset time.

the costoclavicular block (ccb) constitutes a relatively novel technique for infraclavicular brachial plexus blockade, whereby local anesthetics (las) are injected inside the costoclavicular space. in this location, the 3 cords of the brachial plexus are very tightly clustered together; this topography would theoretically result in a very swift brachial plexus block unfortunately, in two recent trials comparing ccb and conventional infraclavicular brachial plexus block, the authors were unable to detect differences in success rate, onset times and la requirement between the 2 methods. it could be speculated that the explanation resides in dynamic cord dispersion. with ccb, the initial needle target lies in the middle of the 3 cords of the brachial plexus. however, with la injection, the cords can quickly migrate away from each other. thus, the anatomical benefits conveyed by the initial compact topography may be lost. in this trial, the objective is to compare single- and double-injection ultrasound-guided costoclavicular blocks. the rationale behind this idea is that a second local anesthetic injection, inside the costoclavicular space, may compensate for the dynamic cord dispersion seen with the single-injection technique. thus the research hypothesis is that, compared to its single-injection counterpart, a double injection costoclavicular block will result in a shorter onset time.

Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * american society of anesthesiologists classification 1-3 * body mass index between 18 and 30 exclusion criteria: * adults who are unable to give their own consent * pre-existing neuropathy (assessed by history and physical examination) * coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, international normalized ratio ≥ 1.4 or partial thromboplastin time ≥ 50) * renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100) * hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100) * allergy to local anesthetic * pregnancy * prior surgery in the infraclavicular costoclavicular region * chronic pain syndromes requiring opioid intake at home