Kornimate/medical-research-clean huggingface dataset:
fitting of commonly available face masks for late preterm and term infants

Conditions: Face; Newborn; Preterm Infant

Summary: around ten percent of newborn infants require positive pressure ventilation (ppv) in the delivery room. this is most commonly delivered using a round or anatomically shaped face mask attached to a t-piece device, self-inflating bag or flow-inflating bag. face mask ventilation is a challenging technique and difficult to ensure that an appropriate tidal volume is delivered because large and variable leaks occur between the mask and face. it is recommended by international guidelines to start with mask ventilation by placing a fitting face mask on the babies face. a fitting face mask covers the mouth and nose. a non-fitting overlaps the eyes and the chin, which causes a airleak. studies report variable leak, sometimes more than 50% of inspiratory volume, during ppv in preterm infants in the delivery room. the presence of a large leak may lead to ineffective ventilation and an unsuccessful resuscitation. a study performed in preterm infants showed that most masks available are too big for the majority of those infants. the investigators hypothesis is that the commonly available face masks for term infants are similarly too big for some term and late preterm infants (≥ 34 weeks gestation).

the investigators would like to measure the dimensions of the faces of late preterm and term infants (≥ 34 ssw) within the first 72 hours of life and compare this data with the size of the most recommended available face masks: vbm germany: external diameter smaller mask: 50 mm, external diameter bigger mask: 70 m laerdal: external diameter smaller mask: 50 mm; external diameter bigger mask: 60 mm fisher\&paykel: external diameter smaller mask: 50 mm; external diameter bigger mask: 60 mm therefore the investigators want to collect the following information from the participants: picture of the participant´s face (2d and 3d-image) birth weight, head circumference, mode of delivery, gestational age, singletons/ twins/ triplets, date of birth

Eligibility criteria:
inclusion criteria: * late preterm and term infants, gestational week ≥ 34 +0 * born at the university hospital of tuebingen * signed declaration of consent from the parents * ≤ 72 hours exclusion criteria: * congenital facial anomalies * any respirators or other medical device that covers the face * missing declaration of consent from the parents
phase i study of high-dose cyclophosphamide and total body irradiation with t lymphocyte-depleted autologous peripheral blood stem cell or bone marrow rescue in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: objectives: i. determine the efficacy, in terms of disease progression, of high-dose cyclophosphamide and total body irradiation with t lymphocyte-depleted autologous peripheral blood stem cell or bone marrow rescue in patients with multiple sclerosis.

protocol outline: following an induction course of cyclophosphamide iv, patients receive filgrastim (g-csf) subcutaneously (sc) daily until the completion of peripheral blood stem cell (pbsc) harvesting. pbscs are collected over several days. patients who do not mobilize sufficient cells undergo bone marrow harvest. harvested pbscs or bone marrow then undergo t-lymphocyte depletion. patients receive cyclophosphamide iv over 1 hour on days -6 and -5 and methylprednisolone iv daily on days -4 to -1. patients also undergo total body irradiation twice a day on days -4 to -1. lymphocyte-depleted pbscs or bone marrow is reinfused on day 0. patients receive g-csf sc daily beginning on day 0 and continuing until blood counts have recovered for 3 days. patients are followed at 1, 2, 3, 6, and 12 months and then annually for 5 years.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnosis of multiple sclerosis kurtzke score of 4.0-7.5 increase of 1.0 point over the past 12 months more than 3 relapses in 24 months despite conventional disease modifying therapy failure to stabilize active clinical progression with a 3-day regimen of methylprednisolone iv --prior/concurrent therapy-- chemotherapy: no prior cladribine radiotherapy: no prior radiotherapy to greater than 10 cm2 of lung tissue no prior craniospinal irradiation no prior total lymphoid irradiation --patient characteristics-- hematopoietic: absolute neutrophil count at least 1,000/mm3 platelet count at least 100,000/mm3 hemoglobin at least 9.0 g/dl hepatic: hepatitis b antigen negative bilirubin no greater than 2.0 mg/dl transaminases no greater than 2 times upper limit of normal renal: creatinine no greater than 2.0 mg/dl cardiovascular: no history of coronary artery disease resting lvef at least 45% pulmonary: fev1/fvc at least 75% predicted dlco at least 50% predicted other: * not pregnant * negative pregnancy test * fertile patients must use effective contraception * hiv negative * no uncontrolled diabetes mellitus * no other concurrent medical illness that would preclude study * no concurrent psychiatric illness or mental deficiency that would preclude study * no prior malignancy except localized basal cell or squamous cell skin cancer (malignancies judged to be cured by local surgical therapy such as head and neck cancer or stage i breast cancer, are considered on an individual basis) * no presence of body shrapnel, metal fragments, or unremovable devices such as a pacemaker or aneurysm clip

Keywords: multiple sclerosis neurologic and psychiatric disorders rare disease
atacicept in multiple glomerular diseases

Conditions: pMN; IgAN; Nephrotic Syndrome; MCD; FSGS

Summary: the purpose of this study is to evaluate the safety and tolerability of atacicept in adult and adolescent participants and to measure the effect in reducing proteinuria and preserving renal function.

the study will assess the safety and efficacy of atacicept in multiple autoimmune glomerular diseases including igan (iga nephropathy), pmn (primary membranous nephropathy) and mcd/fsgs (minimal change disease/focal segmental glomerulosclerosis) in participants ages 10 and above with weekly sc injections.

Eligibility criteria:
inclusion criteria: * weight of at least 40 kg * on a stable prescribed standard of care (soc) treatment regimen according to local guidelines and the specific requirements for each disease * systolic blood pressure ≤160 mmhg and diastolic blood pressure ≤90 mmhg at screening. for participants aged ≥10 to \<18 years, the average of 3 separate systolic and/or diastolic blood pressures \<95th percentile for age, gender, and height diagnosis of igan, igavn, pmn, mcd, fsgs, or primary nephrotic syndrome for patients enrolling in igan cohorts (eligibility varies by cohort): * age ≥ 10 years * biopsy proven igan or igavn, * upcr ≥ 0.5 g/g * egfr≥ 20 ml/min/1.73m2 for patients enrolling in pmn cohorts (eligibility varies by cohort): * age ≥ 18 years * biopsy-proven pmn * anti pla2r antibodies ≥ 25 ru/ml * upcr ≥ 1.5 g/g * at low risk for spontaneous remission (based on severity or duration of disease) for patients enrolling in nephrotic syndrome cohorts (mcd, fsgs, or pediatric idiopathic nephrotic syndrome): * age ≥ 10 years * egfr≥30 ml/min/1.73m2 * biopsy diagnosis of primary mcd or fsgs (adults) or challenging clinical course with steroids in children (frequenlty relapsing, steroid-dependent, or steroid-resistant) * upcr ≥ 1.0 g/g at screening, * evidence of anti-nephrin antibodies * evidence of rapidly progressive glomerulonephritis (loss of ≥50% of egfr) within 3 months prior to and at screening) * active viral or bacterial infections * existing conditions or clinically significant laboratory abnormalities that may interfere with participation in this study * administration of live and live-attenuated vaccinations within 30 days prior to enrollment * known hypersensitivity to atacicept or any component of the formulated atacicept * additional criteria apply to each cohort/disease.

Keywords: iga glomerulonephritis iga nephropathy iga nephropathy 1 immunoglobulin a nephropathy nephritis iga type nephropathy, iga primary membranous nephropathy nephrotic syndrome immunoglobulin a (iga) immunoglobulin a vasculitis with nephritis (igavn) anti-pla2r associated membranous nephropathy (pla2r-mn) idiopathic/primary nephrotic syndrome (mcd/fsgs) urologic diseases female urogenital diseases female urogenital diseases and pregnancy complications urogenital diseases male urogenital diseases glomerulonephritis nephritis autoimmune diseases immune system diseases kidney diseases glomerulonephritis, iga
posterior capsule opacification following cataract surgery with implantation of the mics iol l313

Conditions: Posterior Capsule Opacification

Summary: this study collects intra- and postoperative data from the patients´charts retrospectively and evaluates retro- and prospectively the rate of posterior capsule opacification (pco) following implantation of the intraocular lens l 313.

this study is a postmarket study without interventions. within the standard care cataract surgery the participants have been implanted with the intraocular lens l313 in the period between september 2009 and december 2013. as criterium for the pco was considered the nd:yag capsulotomy. in the first step of the study, data was collected from the patients´charts. in the second phase, a questionaire was sent to the patients with no recent examination, asking them to answer whether or not participants received a laser procedure due to pco. in doubt the participants could answer: "i am not certain". for this step the investigator ensured the positive votum of the ethic committee of the university of greifswald, germany. on the third step of the study, the patients that were not certain of having such a laser procedure or did not answer per post, will be contacted on telephone. by uncertainty or no answer on the telephone the family eye doctor will be contacted to receive the necessary information. if the eye doctor has lost contact to the patient, then this patient will be documented as lost-to-follow-up. excluded were the patients that live \>50km from the department of ophthalmology in neubrandenburg, as well as patients with intraoperative capsule tear. for the statistical analysis was used the program statistica (statsoft, hamburg, germany) and the survival analysis using the kaplan-meier formula, the statistical significance using the chi-squared test and spearman-rank corelation and the bonferroni adjustment if the test was repeated. the investigators compared these results with the results of other publication. in order to do that the investigators calculated the capsulotomy quote from this study according to the time of the pco recorded on the other studies. included were only comparing studies that also used yag-capsulotomy as criterium for the pco. furthermore secondary data was collected: age, gender, cutting length, core hardness, duration of whole operation, time of phaco-emulsification, phaco-energy, phaco-machine, combination with other operation, surgeon, power of iol. this data will be taken in concern for the validity of this study.

Eligibility criteria:
inclusion criteria: * retrospective: patients who have undergone a cataract surgery with implantation of iol l313 * prospective: signed informed consent exclusion criteria: * capsule rupture * patients with too much travel distance between study center and home

Keywords: yag-laser capsulotomy
protocol for radiofrequency ablation of pulmonary neoplasms

Conditions: Pulmonary Neoplasms

Summary: this research trial involves the development of a new treatment for lung tumors. it is for patients whose tumor cannot be surgically removed, have refused surgery, or the tumor has not responded well to other forms of treatment. this treatment uses a needle probe to deliver energy into the lung tumor. this probe is placed utilizing a ct scan image. the energy heats the tumor causing tumor cell death.


Eligibility criteria:
inclusion criteria: the patients enrolled in this study should be judged to have sufficient survival to benefit from control of local disease and include at least one of the following: 1. unresectable primary or metastatic lung tumors 2. may benefit from multiple modalities of therapy 3. chemotherapeutic or radiation oncologic options have been exhausted exclusion criteria: 1. co-existing morbidities that preclude the use of surgery
measuring hand edema in burn patients

Conditions: Edema

Summary: the purpose of this study is to determine the reliability and concurrent validity of the figure-of-eight method of measuring hand edema in the burn patient population. establishing the reliability and validity would enable a more time efficient assessment than the currently accepted methods.

a prospective study involving 33 burn patients admitted to the us army burn center. two raters will perform three separate blinded measurements for hand edema using the figure-of-eight measurement technique. a third rater will then perform two blinded measurements using water volumetry. all measurements will be read and recorded by an independent recorder. the three measurements of rater 1 and 2 will be analyzed to determine intratester reliability. the average of the three figure-of-eight measurements will be compared to measure intertester reliability. the two volumetry measurements will be compared to determine intratester reliability. the average of the 2 volumetry measurements and the average fo the three figure-of-eight measurements will be used to determine concurrent validity.

Eligibility criteria:
inclusion criteria: * male or female 18-89 years old * admitted to the united states (u.s.) army burn intensive care unit (icu) or ward with burn injury and the presence of bilateral or unilateral hand edema exclusion criteria: * subject unable to be placed in test position for volumetry testing or the presence of a medical condition, as defined by a physician, that precludes the safe use of volumetry. * subject is unable to tolerate his/her hand(s) being immersed in room temperature water for volumetry testing. * subject does not have any of the bony landmarks (due to amputation, previous surgery) required to perform the figure-of-eight measurement

Keywords: hand edema figure of eight method measuring edema in burn patients
long-term study in chronic kidney disease (extension from study 14817)

Conditions: Hyperphosphatemia

Summary: the objective of this study is to investigate the safety and the effect on reduction of serum phosphate of long-term administration of lanthanum carbonate (bay77-1931) 750 to 2250 mg in patients with hyperphosphatemia who completed the 8 week double-blind treatment period of study 14817 and are judged to be eligible for the long-term extension study.


Eligibility criteria:
inclusion criteria: * patients who have completed the 8-week double-blind treatment period of study 14817 and are judged to be eligible for the long-term extension study by the investigator (including those who plan to be on dialysis during the long-term extension study). exclusion criteria: * patients with any other conditions that the investigator defines as not appropriate to be enrolled in the study

Keywords: long-term study in chronic kidney disease lanthanum carbonate
the association between blood eosinophilsp in thai copd patients: a prospective study

Conditions: Copd

Summary: the association of blood eosinophil as a biomarker for eosinophilic thai copd patients, such as copd exacerbation, hospital admission, lung functions and mortlity.

the prospective one year study in thai copd patients for the clinical outcomes of copd compare between eosinophilic and non-eosinophilic which determine by blood eosinophil counts equal or more than 300 cells/microliters. the primary outcomes was copd exacerbation, the secondary outcomes were lung function, dyspnea and quality of life.

Eligibility criteria:
inclusion criteria: * diagnosis of copd by gold criteria exclusion criteria: 1. high blood eosinophil from known causes such as systemic corticosteroid use, malignancy, parasitic infection 2. patients who had previous acute exacerbation within 30-day before study entry 3. patients who had previous systemic corticosteroids used within 30-day before study entry
pharmacokinetic study to compare two formulations of paracetamol

Conditions: Fever; Headache Disorders; Pain

Summary: a pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast release in fasted state.


Eligibility criteria:
inclusion criteria: * healthy male volunteers aged 18-55yrs willing to give written informed consent for the study * bmi must be within the range 18.5 - 24.9 kg/m\^2 * participant with a minimum weight of 50 kg exclusion criteria: * participant with current or recurrent disease that could affect the action, absorption or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure) * participant with known or suspected intolerance or hypersensitivity to the study materials * participant who are vegetarian * participant smoking more than five cigarettes a day
an open-label study of pregabalin in subjects with refractory partial seizures

Conditions: Epilepsy

Summary: the main purpose of this trial is to allow continued access to pregabalin to canadian subjects who participated in global pregabalin epilepsy studies 1008-010; 1008-035; 1008-114 and 1008-164 and to continue to study the long term safety of pregabalin administered as adjunctive therapy at dosages from 150 mg/day to 600 mg/day in canadian subjects with refractory partial seizures.


Eligibility criteria:
inclusion criteria: * must have completed pfizer open-label studies 1008-010; 1008-035; 1008-114 or 1008-164 and wishes to continue receiving open-label pregabalin * must have responded favorably to pregabalin in pfizer open-label study 1008-010, 1008-035, 1008-114 or 1008-164 and in the clinical opinion of the investigator continued treatment with pregabalin is in the the patient's best medical interest exclusion criteria: * is pregnant or is considering becoming pregnant during the course of the study * experienced a serious adverse event during open-label pfizer study 1008-010, 1008-035, 1008-114 or 1008-164
randomized study of velcade-based regimen with autologous stem cell transplantation in newly-diagnosed myeloma patients

Conditions: Multiple Myeloma

Summary: the is a randomized control study for newly-diagnosed myeloma patients 18-65 year old. all patients will receive 4 cycles of velcade and dexamethasone as front-line therapy. then patients will be randomized into standard group which will receive a single autologous hematopoietic stem cell transplantation with standard conditioning of melphalan 200mg/m2 and the study group which will receive single autologous hematopoietic stem cell transplantation with conditioning of melphalan 200mg/m2 + velcade followed by 3 more cycles of velcade alone as consolidation.

the is a randomized control study for newly-diagnosed myeloma patients 18-65 year old. newly-diagnosed myeloma patient enrolled will receive 4 cycles of velcade and dexamethasone as front-line induction therapy. all patients finished the induction therapy will be randomized into standard group and the study group. all patients will mobilized by cyclophosphamide with g-csf to collect a target of 2x106 cd34+/kg and then undergo autologous stem cell transplantation. for standard group, patients will receive single auto-sct with standard conditioning of melphalan 200mg/m2. the patients in the study group will receive single auto-sct with conditioning of melphalan 200mg/m2 added with 4 dose of velcade at 1.0mg/m2 during the transplantation procedure and then followed by 3 more cycles of velcade alone as consolidation.

Eligibility criteria:
inclusion criteria: * man or woman between age 18-65 with newly diagnosed multiple myeloma for whom stem cell transplantation is considered appropriate * measurable serum and/or urinary paraprotein * european cooperative oncology group performance status 0-3 * serum bilirubin \< 1.5x the upper limit of normal (uln) serum alanine transaminase (alt)/aspartate transaminase values \< 2.5 x uln * subjects (or their legally acceptable representatives) must signed an informed consent document indicating that they understanding the purpose of and procedures required for the study and are willing to participate in the study exclusion criteria: * woman of child bearing potential * non-secretory mm * serum creatinine \> 400 micromol/l after initial resuscitation patients with previous grade 2-4 peripheral neuropathy * uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug) * uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or iii-iv heart failure

Keywords: multiple myeloma autologous stem cell transplantation velcade
facial block for outpatient rhinoplasty analgesia

Conditions: Outpatient Rhinoplasty

Summary: a bilateral facial block (infraorbital and infratrochlear) will be performed immediately after intubation in patients undergoing outpatient rhinoplasty with 2.5% levobupivacaine (intervention group) or saline as control. intravenous saline or morphine will be administered at the end of surgery in intervention or control groups, respectively. in case of pain in post-anesthesia care unit (numerical pain score \>3 on a 0-10 scale), both groups will receive intravenous morphine titration. the total perioperative morphine consumption (intraoperative and in post-anesthesia care unit) will be compared between groups. pain intensity, presence of nausea/vomiting and patient's satisfaction will be compared between groups.


Eligibility criteria:
inclusion criteria: * outpatient rhinoplasty * american society of anesthesiologists (asa) classification i-ii * affiliated to social security * written informed consent exclusion criteria: * allergy to levobupivacaine * incapacity to give consent * chronic pain

Keywords: facial block levobupivacaine regional anesthesia rhinoplasty outpatient