Kornimate/medical-research-clean huggingface dataset:
effects of cerebral and peripheral electrical stimulation on conditioned pain modulation in healthy subjects.

Conditions: Healthy Volunteers

Summary: the neuromatrix pain model and new findings on pain chronification process point to a greater efficacy of treatments that address central and peripheral rather than only peripheral structures. both cerebral and peripheral electrical stimulations can modulate brain areas involved in pain processing. however, their effects on pain modulation systems and clinical outcomes are lacking. this study aims to investigate the efficacy of transcranial direct current stimulation (tdcs) and peripheral electrical stimulation (pes) alone as well tdcs combined with pes on pressure pain threshold and conditioned pain modulation in healthy subjects.


Eligibility criteria:
inclusion criteria: healthy subjects without medical complaints. exclusion criteria: concurrent medication likely to affect cognitive performance pregnancy or possible pregnancy history of drug or alcohol abuse or dependence recent head injury (in the last 3 months) history of seizure or stroke.
topical brinzolamide ophthalmic suspension versus placebo in the treatment of infantile nystagmus syndrome

Conditions: Infantile Nystagmus Syndrome

Summary: this study is a prospective, single crossover, double-masked, controlled clinical trial that will use topical brinzolamide (azopt)ophthalmic medication to try to improve the nystagmus and visual consequences of nystagmus in patients with infantile nystagmus syndrome (ins). subjects will undergo a clinical exam, questionnaire and eye movement recordings on day 1 and then receive either topical azopt or placebo three times a day in both eyes for days 2,3 and 4 followed on the morning of day 5 by a repeat clinical exam, questionnaire and eye movement recordings. after at least one week, this protocol is repeated with the crossover regimen being taken by the subject. one week after all medications are discontinued, another clinical exam is done before study discharge. the hypothesis is that nystagmus and associated visual symptoms will be improved while on the azopt compared to the placebo. there will be a total of 5 visits over a 1-2 month period.

5 subjects are expected to be enrolled in the study. each subject will be in the study for approximately 1 month. efficacy will be assessed by: * etdrs visual acuity testing of binocular best corrected visual acuity in the nystagmus null zone * the validated amblyopia \& strabismus ocular motor questionnaire * eye movement recording data analysis of the nystagmus waveform safety will be evaluated by: * ocular signs and symptoms * visual acuity (uncorrected and best corrected) * slit lamp exam and intraocular pressure * systemic signs and symptoms

Eligibility criteria:
inclusion criteria: * age; greater than 12 years old and able to cooperate for full study protocol * subject able to understand and sign informed consent * subject able to participate in complete ophthalmic and ocular motility evaluation * subjects with infantile nystagmus syndrome diagnosed by clinical evaluation and eye movement recordings * best-binocular visual acuity in null position 20/50 to 20/200 inclusive using ats or etdrs vision testing * subject/family able and willing to make the required study visits * no previous ophthalmic treatment for nystagmus other than for refractive error exclusion criteria: * any current use of systemic or topical medications (traditional or non-traditional) * history of ocular surgery, trauma or chronic ocular disease other than amblyopia * systemic diseases requiring medication or other treatments that are known to affect the ocular motor system (e.g., depression, seizure disorders, psychosis) * behavioral or neurological disorders which interfere with the study * physical or mental impairment precluding study compliance * participation in any study involving an ind investigational drug within the past year * individual (female) is pregnant, nursing or planning a pregnancy (the safety of azopt for use during pregnancy has not been determined.) * periodicity or aperiodicity of ins present on eye movement recordings * allergy to sulfa or other components of azopt solution
the effect of surfactant dose on outcomes in preterm infants with rds

Conditions: Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Summary: a prospective observational study using de-identified data from the neonatal network research database (nnrd) supplemented by additional information on dose, method of surfactant administration and dosing frequency to assess whether the dose and method of administration of surfactant given to preterm infants with respiratory distress syndrome (rds) affects neonatal outcomes.

the rationale for this study is the clinical relevance of understanding whether surfactant dose affects neonatal outcomes in infants with rds who are treated in the immediate postnatal period. in a research environment, the dose of surfactant is rigorously controlled, usually administered at a dose of 100mg/kg or 200mg/kg. in clinical practice, clinicians more frequently follow the 'whole vial dosing' approach, where a full vial is given aiming to get as close as possible to the desired dose. reasons for whole vial use include reduction of waste and administration of surfactant shortly after birth where an infant's weight is unknown. it is unclear whether whole vial dosing leads to under-dosing or over-dosing and whether either situation affects outcomes. information regarding the dose of surfactant delivered, and the method of administration, are not currently routinely recorded in the uk. the primary objective of the study is to compare two dosing groups (100-130 mg/kg and 170-200 mg/kg) in terms of the proportions of infants who require mechanical ventilation within four days of birth.

Eligibility criteria:
inclusion criteria: * \<37 weeks gestational age requiring surfactant for respiratory distress syndrome record of birth weight available born after study initiation exclusion criteria: * 37 weeks gestation age or above parental opt-out

Keywords: surfactant less invasive surfactant administration mechanical ventilation
continuous lidocaine infusion for management of perioperative burn pain

Conditions: Thermal Burns

Summary: thermal injury results in one of the most intense and prolonged forms of pain the body can experience. opioid narcotics are the most powerful drugs for acute and chronic pain, and their use in the perioperative period has been the mainstay of treatment; although medication requirements in burn patients are often underestimated. more medication may not be the answer, as relatively large doses of short acting opioids in the operative theater are associated with greater postoperative opioid consumption and higher pain scores. furthermore, extensive use of opioids has resulted in the development of by hyperalgesia and allodynia. lidocaine is an amide local anesthetic that has analgesic, anti-hyperalgesic, antiarrhythmic, and anti-inflammatory properties. over the past 25 years, systemic lidocaine has been used for perioperative pain management in a variety of surgical procedures. the design of this study will examine if lidocaine will reduce the pain scores and narcotic utilization in patients undergoing surgical procedures for burn injuries. the intervention group will receive a bolus dose of lidocaine followed by a continuous infusion over 24 hours. the control group will get an equal volume of saline. the investigators will compare pain scores, opioid use, and narcotic equivalents based on body weight and burn surface area (bsa) grafted.


Eligibility criteria:
inclusion criteria: * burn patient ≥ 18 years of age * burn patient scheduled to go to or for excision and/or grafting procedure exclusion criteria: * burn patient \< 18 years of age * intubated patient on sedation drip * prolonged hypotension defined as systolic blood pressure (sbp) \< 90 mm/hg for greater than 30 minutes in the pre-op area * severe underlying cardiovascular disease (documented ejection fraction \< 40%) * documented conduction block, bradycardia or active congestive heart failure * documented active gastritis or ulcers * previous steroid medication history if documented adrenal insufficiency * patient with documented liver disease * patient with epilepsy or known seizure disorder * pregnant women

Keywords: pain management narcotic consumption skin graft
different regimens of transarterial chemoembolization for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate efficacy, safety, and patient reported outcomes (pro) of different regimens of transarterial chemoembolization (tace) in patients with hepatocellular carcinoma (hcc).

transarterial chemoembolization (tace) has been recommended as first line non-curative therapy for non-surgical patients with large/multifocal hcc who do not have vascular invasion or extrahepatic spread. there has not been any standardized protocol in the choice of chemotherapeutic agents, dosage, dilution, rate of injection, and time interval between treatments. similarly, there is no agreement on the choice of embolizing agents, degree of embolization, and whether the chemotherapeutic agent should be given together, or before the embolizing agent. comparison(s): in patients with hcc who underwent tace therapy, stratified by whether they have vascular invasion and tumor size, we compare efficacy, safety, and patient reported outcomes (pro) of different regimens of tace. regimen 1: lipiodol combined chemotherapy with embolization regimen 2: lipiodol combined chemotherapy without embolization regimen 3: lipiodol single agent chemotherapy with embolization

Eligibility criteria:
inclusion criteria: * adult patients with minimal height of 150cm and minimal weight of 50 kg * histological confirmed hcc * with no previous treatment * with unresectable tumor * with solitary or multiple intrahepatic tumor, the diameter of the largest one must larger than 7cm. * no significant baseline liver dysfunction. cirrhotic status of child-pugh class a only * no significant renal impairment (creatinine clearance \< 30 ml/minute) * the following laboratory parameters: * platelet count ≥ 60,000/µl * hemoglobin ≥ 8.5 g/dl * total bilirubin ≤ 1.5 mg/dl * asl and ast ≤ 5 x upper limit of normal * serum albumin ≥ 35 g/l * serum creatinine ≤ 1.5 x upper limit of normal * inr ≤ 1.5 or a pt/ptt within normal limits * absolute neutrophil count (anc) \> 1,500/mm3 * ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * avascular tumor * main portal vein obstruction without cavernous transformation * evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy * obstructive jaundice * severe underlying cardiac or renal diseases * known or suspected allergy to the investigational agent or any agent given in association with this trial * pregnant or breast-feeding patients. * history of organ allograft * active clinically serious infections * any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study

Keywords: antineoplastic agents administration & dosage carcinoma, hepatocellular chemoembolization, therapeutic humans liver neoplasms therapy
the effects of epinephrine in endotoxemia in normal volunteers

Conditions: Immune System

Summary: epinephrine (adrenaline) is a substance produced by the body (in the adrenal gland) in response to stress such as infection or injury. endotoxin is a man- made substance, which causes the body to "mimic" sickness (fever, chills, and achiness) for a few hours. this study is designed to give epinephrine before and/or after endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by endotoxin.

the body's immune response to injury otr infection is very complex. immune cell activity, the release of specific mediators (such as proteins), genetics (deoxyribonucleic acid or dna) and/or the body's "instructions" for making proteins (ribonucleic acid or rna) may effect the body's clinical response to a stress such as an infection.epinephrine (adrenaline) is a substance produced by the body (in the adrenal gland)in response to stress such as infection or injury. endotoxin is a man- made substance, which causes the body to "mimic" sickness (fever, chills, and achiness) for a few hours. this study is designed to give epinephrine before and/or after endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by endotoxin.in addition, this study may determine whether any of the above(proteins,dna,rna,etc.) correlate with or affect the body's response to epinephrine and/or endotoxin. this will enable the investigator to better understand whether treatment with this substance can alter the body's immune response.

Eligibility criteria:
inclusion criteria: * general good health as demonstrated by medical history, physical\& laboratory tests * age between 18 and 40 years * written informed consent prior to the performance of any study related procedures exclusion criteria: * history of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension * any medication taken in past 48 hrs (except birth control) * recent history of alcohol or drug abuse * unable to provide written informed consent * exposure to any experimental agent or procedure within 30 days of study * pregnant or breast-feeding
tomotherapy in postsurgery recurrent carcinoma cervix

Conditions: Postsurgery Recurrent Carcinoma Cervix

Summary: radiotherapy is the most appropriate treatment for postoperative recurrent carcinoma cervix. however it is technically difficult to deliver adequate doses of rt due to presence of small intestines in the radiation area; thus disease control rates are poor and complication rates are high with conventional radiotherapy. use of imrt and brachytherapy for these cases allows for increasing dose to the tumor while sparing normal structures. it is expected that the use of a combination of imrt \& brachytherapy will achieve higher disease control rates and decrease the complication rates.

specific objectives: 1. to evaluate the efficacy of combination of intensity-modulated radiotherapy (imrt) and brachytherapy in delivering dose escalated radiotherapy in postoperative residual / recurrent cases of carcinoma cervix, in terms of local control proportion and progression free survival (pfs) 2. to study the late and acute toxicities associated with this treatment. 3. dosimetric comparison of tomotherapy and conventional imrt design: prospective, phase ii study. study population: all patients of age \< 65 years diagnosed with postsurgery recurrent squamous cell carcinoma cervix without previous history of radiotherapy. study size: 90 patients methodology: ninety cases of cervical cancer with postsurgery recurrence limited to the pelvis will be screened and taken for study if eligible after taking the informed consent. patients will receive external radiation therapy using imrt to pelvis with additional dose of localized radiotherapy boost with brachytherapy to the vault with weekly concurrent chemotherapy. the local recurrence rate and 5 year disease free survival rate of all the patients will be studied. project period: total project period : 5 years recruitment, data collection : 4 years complete analysis of data : 1 year study site: tata memorial centre

Eligibility criteria:
inclusion criteria: . only histologically proven postoperative recurrence of squamous carcinoma of cervix following hysterectomy \>3 months without adjuvant treatment * patients below 65 years of age and with kps \>70%. * patients with disease confined to the pelvis, based on ct/mri/pet scan * normal ecg and cardiovascular system * normal hematological parameters * normal renal and liver function tests exclusion criteria: * previous chemotherapy or radiotherapy to the pelvis * pelvic ln \>3cm in size * presence of disease outside the pelvis (paraortic nodes, distant metastasis) * bilateral hydronephrosis * co-morbid conditions like uncontrolled diabetes mellitus or medical renal disease * medical or psychological condition that would preclude treatment * patient unreliable for treatment and follow-up.

Keywords: recurrent carcinoma cervix vault carcinoma tomotherapy brachytherapy
a randomised trial evaluating continuous subcutaneous infusion of formulations of nn1218 and novolog® in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in the united states of america (usa). the aim of the trial is to evaluate continuous subcutaneous infusion of nn1218 formulations and novolog® in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (diagnosed clinically) for at least 12 months prior to the screening visit (visit 1) * treatment with the same insulin analogue by csii (continuous subcutaneous insulin infusion) for the previous 3 months prior to the screening visit (visit 1) * using a minimed paradigm® pump (515/715, 522/722 or 523/723) for the previous 6 months prior to the screening visit (visit 1) * glycosylated haemoglobin (hba1c) below or equal to 9.0% by central laboratory * body mass index (bmi) below or equal to 35.0 kg/m\^2 exclusion criteria: * history of diabetic ketoacidsosis (dka) episodes requiring hospitalization within 6 months prior to the screening visit (visit 1) * history of abscess at the infusion site within 6 months prior to the screening visit (visit 1) * hypoglycaemic unawareness as judged by the investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to the screening visit (visit 1)
clinical evaluation of two toric soft contact lenses

Conditions: Astigmatism

Summary: the aim of this study is to compare the short-term clinical performance of two toric contact lenses.

the aim of this study is to evaluate the short-term clinical performance of two toric contact lenses when compared to each other after 15 minutes of daily wear each

Eligibility criteria:
inclusion criteria: * is between 18 and 40 years of age (inclusive) * has had a self-reported visual exam in the last two years. * is an adapted soft contact lens wearer. * is not a habitual wearer of either study lens. * has a contact lens spherical prescription between +5.00 to -9.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye. * have contact lens prescription of no less than -0.75d of astigmatism and no more than -2.25d in both eyes. * can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logmar) or better in each eye. * can achieve a distance visual acuity of 20/30 (0.18 logmar) or better in each eye with the study contact lenses. * has clear corneas and no active ocular disease. * has read, understood and signed the informed consent letter. * patient contact lens refraction should fit within the available parameters of the study lenses. * is willing to comply with the wear schedule (at least 5 days per week, \>8 hours/day assuming there are no contraindications for doing so). * is willing to comply with the visit schedule. exclusion criteria: * has a cl prescription outside the range of the available parameters of the study lenses. * has a spectacle cylinder less than -0.75d or more than -2.50d of cylinder in either eye. * slit lamp findings that would contraindicate contact lens wear such as: 1. pathological dry eye or associated findings 2. pterygium, pinguecula, or corneal scars within the visual axis 3. neovascularization \> 0.75 mm in form of the limbus 4. giant papillary conjuctivitis (gcp) worse than grade 1 5. anterior uveitis or iritis (past or present) 6. seborrheic eczema, seborrheic conjunctivitis 7. history of corneal ulcers or fungal infections 8. poor personal hygiene 9. has a know history of corneal hypoesthesia (reduced corneal sensitivity) 10. has aphakia, kertaoconus or a highly irregular cornea. 11. has presbyopia or has dependence on spectacles for near work over the contact lenses. 12. has undergone corneal refractive surgery. 13. is participating in any other type of eye related clinical or research study.
fertility after intrauterine tamponing balloon: where are we

Conditions: Hemorrhage Postpartum; Fertility Disorders

Summary: today, few data are available on the patient's fertility following intrauterine tamponade balloon (btiu) used for postpartum hemorrhage (pph) after vaginal delivery (avb). several studies have concluded that there are no fertility disorders after conservative surgical treatment or embolization. btiu is an essential treatment in the management of pph. the aim was to evaluate post-btiu fertility and the appearance of gynecological symptoms. this is a bicentric retrospective study (valenciennes, lille, france), between 2012 and 2017. the data will be collected by telephone interview on fertility and various gynecological functional symptoms.


Eligibility criteria:
inclusion criteria: * vaginal birth * post partum haemorrhage * intrauterine tamponing balloon * between 2012 and 2017 * chru lille and ch valenciennes exclusion criteria: * minor patients * initial intake started in another center (postpartum transfer). * refusal to participate in the study * invasive treatments for postpartum haemorrhage * caesarean

Keywords: hemorrhage post-partum fertility uterine balloon tamponade vaginal birth
minirigid versus conventional rigid thoracoscopy in undiagnosed pleural effusions

Conditions: Pleural Effusion

Summary: consecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural biopsies will be enrolled in the study. one hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy to the following groups: group a (mini-thoracoscopy) group b (conventional rigid thoracoscopy) primary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions

a significant proportion of patients with pleural effusions remain undiagnosed after performance of diagnostic procedures including cytological and microbiologic analysis of the pleural fluid and closed pleural biopsies. in this study, the investigators plan to compare the yield and safety of mini-thoracoscopy and conventional rigid thoracoscopy with the larger diameter scope. this is a prospective study that will be conducted at the thoracic endoscopy suite of the department of pulmonary medicine, pgimer, chandigarh. consecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural biopsies will be enrolled in the study one hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy. the randomization sequence will be generated using a computer (in blocks of 10), and the allocation will be placed in opaque sealed envelopes. the patients will be randomized to the following groups: group a (mini-thoracoscopy): the mini-thoracoscope manufactured by richard wolf gmbh, knettligen, germany will be used. it has an outer diameter of 5.5 mm and a working channel diameter of 3.5 mm. group b (conventional rigid thoracoscopy): the rigid thoracoscope manufactured by richard wolf gmbh, knettligen, germany will be used that has an outer diameter of 10 mm and channel internal diameter of 5 mm. primary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions.

Eligibility criteria:
inclusion criteria: * medical thoracoscopy being performed for obtaining a pleural biopsy exclusion criteria: * pao2/fio2\< 300; hemodynamic instability myocardial infarction or unstable angina in the last 6 wk lack of pleural space due to adhesions uncorrected coagulopathy failure to provide informed consent

Keywords: thoracoscopy pleuroscopy metastatic cancer lung cancer malignant pleural effusion tuberculosis