Kornimate/medical-research-clean huggingface dataset:
measurements of csf shunts and off-shunt locations with wireless thermal anisotropy measurement devices

Conditions: Hydrocephalus

Summary: this study collects data using non-invasive devices for assessing csf shunt flow using thermal anisotropy measurements in a prospective study setting. the study will collect data to compare measurements from flowing shunts, non-flowing shunts, and off-shunt locations.


Eligibility criteria:
inclusion criteria: 1. at least one existing ventricular csf shunt, functional or non-functional (including an adjustable valve set to "virtual off," ligated shunt, uncorrected distal catheter disconnection or fracture, distal catheter fragment left in place during shunt surgery, or indication that the shunt is otherwise non-functional), with a region of overlying intact skin appropriate in size for application of the study device 2. if more than one distal shunt catheter is present, at least one distal shunt catheter is at least 2 cm away from any other distal shunt catheter in the device measurement region 3. signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) 4. signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) 5. verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision exclusion criteria: 1. presence of an interfering open wound or edema in the flowsense device measurement area 2. patient-reported history of serious adverse skin reactions to silicone-based adhesives 3. use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject 4. participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
paclitaxel polymeric micelles and carboplatin in combination with iparomilimab and tuvonralimab neoadjuvant therapy for triple-negative breast cancer

Conditions: Triple-Negative Breast Cancer (TNBC); Neoadjuvant Therapy

Summary: this is a prospective, single-arm, multicenter study to observe and evaluate the efficacy and safety of paclitaxel polymeric micelles and carboplatin in combination with iparomilimab and tuvonralimab in neoadjuvant therapy for triple-negative breast cancer. the main endpoint of the study is pcr, 32 patients are scheduled to be enrolled.


Eligibility criteria:
inclusion criteria: * triple-negative breast cancer * the diameter of the primary tumor must be greater than 2cm, and the clinical stage should be ii-iii * there is sufficient primary organ function * the ecog (ps) score is 0 or 1 * expected survival ≥ 6 months * the serum pregnancy test was negative. use highly effective methods of contraception during the study period and for 180 days after the last dose of the study drug, and do not breastfeed exclusion criteria: * bilateral breast cancer * there is a history of ductal carcinoma in situ (dcis) or lobular carcinoma in situ (lcis) * a history of invasive or metastatic breast cancer * any malignancy diagnosed within 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma * there is an immune deficiency disease * the presence of any autoimmune disease that still requires treatment or a history of prior autoimmune disease
evaluation of vital capacity

Conditions: Respiration Disorders; Neuromuscular Disease

Summary: respiratory failure is the most common cause of death in neuromuscular diseases. the aim of this research is to evaluate the thoracopulmonary recruitment by comparison of inspiratory vital capacity (vc ins)and inspiratory/expiratory vital capacity (vc ins-ex) with the vital capacity (vc) according to pathology and severity of pulmonary damage of patients with neuromuscular diseases. the methodology consists in realize vc by support of inspiratory/expiratory pressures, while the patient is passive and realizing a maximal inspiratory/expiratory effort simultaneously, with the aid of mechanical insufflation/exsufflation device (cough assist®). the evaluation will last for 30 minutes and the non-inclusion criteria are those for an insufflation. the study hypothesis is that long term insufflation/exsufflation device use could improve thoracopulmonary mobility.


Eligibility criteria:
inclusion criteria: * consent form signature * men and women aged over or equal to 18 years old * medical examination before the research * negative results of tests of pregnancy for the women at age to procreate or taking an effective contraceptive * patients with neuromuscular pathologies without tracheostmy - vital capacity \< 80% of theoretical value exclusion criteria: * refuse to participate at the research * patient under guardianship or under trusteeship * pregnant women * patients unable to cooperate * patients without a security social scheme (as beneficiary or bearer of rights) * usual contra-indications for an insufflation (haemoptise, recent pneumothorax, pulmonary emphysema, pleuresy, nausea, chronic obstructive pulmonary diseasee or asthma, recent lobectomy, intracranial hypertension, troubles of consciousness, unable to talk)
efficacy of chlorexidine as intracanal medicament in primary teeth

Conditions: Dental Pulp Necrosis

Summary: the purpose of this study is to evaluate the action of the chlorexidine as intracanal medicament in the reduction of the levels of bacteria inside root canals of primary molar teeth with pulpal necrosis.


Eligibility criteria:
inclusion criteria: * healthy children of both gender; * without history of reactions or alergical diseases; * with situated age between 04 and 08 years of age * with normal standard of growth and development * patients with necessity of radical endodontic treatment (pulpectomy) in, at least, two primary molar teeth in different hemi-arches. exclusion criteria: * patients with history of alergical diseases * patients with allergy to any type of medicine and/or foods * patients with comprometimento of its general state of health * healthy patients with risk to develop bacterial endocardite or patients that their general state of health can be aggravated had the transitory bacteremies, as for example children with congenital cardiac illnesses * patients who are making use of sistemis antibiotics, or that they have made use of sistemic antibiotic in the period of 3 (three) months before the beginning of the endodontic treatment * with periapical x-ray evidencing less than 2/3 of remaining root of the primary tooth to be treated * patients whose tooth with endodontic necessity to meet in advanced state of root pathological reabsortion * patients whose legal responsible or parents to refuse to sign the term of free and clarified assent

Keywords: primary teeth chlorexidine root canal therapy pulpectomy
launching a salt substitute to reduce blood pressure at the population level in peru

Conditions: Blood Pressure; Hypertension

Summary: this protocol aims to implement, using a stepped wedge trial design, a population-level intervention to replace high-sodium salt for a salt substitute (low-sodium, high-potassium salt) to reduce blood pressure levels among adults aged 18 years and over of the semi-urban area of tumbes. we hypothesize that participants aged 18 years and over from villages receiving a salt substitute will have lower blood pressure compared to control villages.

several randomized clinical trials and meta-analysis have reported that reduction of sodium intake decreases blood pressure. also, the increase of potassium ingestion in minimal doses has been found in systematic reviews to produce a small reduction in blood pressure levels. the proposed intervention is a community-wide mass-strategy in which direct delivery of a salt substitute to households is accompanied by wide social marketing campaigns, both before and during the intervention period. with this experimental stepped wedge trial design, we will estimate the impact of a reduced-sodium salt substitution program on blood pressure at the population level. we propose the following specific aims: specific aim 1: to implement and assess the impact of an intervention using a salt substitute on blood pressure at the population level using a stepped wedge trial design. specific aim 2: to determine costs and efficacy of this implementation strategy using cost-effectiveness analysis.

Eligibility criteria:
inclusion criteria: * males or females aged 18 years and over from the randomly selected villages. * capable of understanding study procedures and providing informed consent. * full-time resident in the area. exclusion criteria: * self-reported history of chronic kidney disease or heart disease. * refusal to participate.

Keywords: blood pressure hypertension stepped wedge trial design
low dose heparin factorial trial

Conditions: Radial Artery Occlusion

Summary: an open label 2x2 factorial randomized trial is planned to determine the difference in mean hemostasis time between low dose heparin (ld) i.e between 2000-3000 iu and standard dose heparin (sd) i.e. 5000 iu with or without catecholamine chitosan-based pad (innoseal hemostatic pad, innotherapy, inc. s korea) used in conjunction with trb (innoseal+trb \[i+trb\]) among patients who are undergoing left heart cath at tabba heart institute. secondary objectives include testing the difference in radial artery occlusion (rao), and hematoma (iii, iv grade) and composite outcome (rao+hematoma).

eligibility criteria: hemodynamically stable adult patients of both genders, who will undergo transradial coronary angiogram (cag) using 6 f sheath will be included. patients who had stemi, are on anticoagulants after procedure or on an ongoing anticoagulation therapy, have ipsilateral arteriovenous fistula, rao at baseline, barbeau's class d will be excluded. intervention: after written consent, first randomization will be done to the heparin arm. if participant falls in ld heparin group, he/she will receive iv heparin 2000-3000 iu (\ 80 kg-3000 iu) at the start of cag and if sd then 5000 iu of heparin will be administered. second randomization will be done to allocate the participant in i+trb or trb alone arm. in i+trb arm, after the completion of cag, at radial artery site, the sheath is pulled 2-3cm and the area surrounding the puncture site is cleaned, dried and innoseal is placed over the puncture site. a transparent adhesive clear dressing is placed over the innoseal and trb is applied over the dressing. in trb arm, trb alone will be applied over the puncture site. in both the arms, 10 cc air will be inserted in trb at the start of the protocol, then at 10, 20, and 30 minutes after the procedure 2cc, then 4cc, and then 6cc or remaining air will be withdrawn. if patient oozes or bleeds from radial site in between the protocol, 2 cc air or more will be inserted to control the bleeding. after reaching 0cc air in trb, deflated trb will be observed for 15 minutes. the trb will be removed and access site will further be observed for 15 minutes for hematoma, oozing/bleeding. at each air draw, reverse barbeau's test will be done to check the radial artery occlusion. if radial pulse is found absent after removing trb, then radial artery colored doppler ultrasound will be done to confirm the radial artery occlusion. the time from the removal of radial sheath till removal of trb will be recorded as the compression time needed to achieve hemostasis at the radial access site.

Eligibility criteria:
inclusion criteria: * hemodynamically stable adult patients of both genders, who will undergo transradial coronary angiogram (cag) using 6 f sheath will be included. exclusion criteria: * patients who had stemi, are on anticoagulants after procedure or on an ongoing anticoagulation therapy, have ipsilateral arteriovenous fistula, rao at baseline, barbeau's class d will be excluded.

Keywords: radial artery occlusion, left heart catheterization, heparin, hemostatic patch
middle ear pressure disregulation in cleft palate patients

Conditions: Cleft Palate

Summary: the investigators know that middle-ear disease is very common in infants with cleft palate and causes hearing loss that can last into childhood. it is thought that a poor ability to keep the pressure in the middle ear at a similar level to that in the environment causes middle-ear disease and that this depends on the opening function of a natural tube that connects the back of the nose with the middle ear, called the eustachian tube. the investigators believe that the middle-ear disease in cleft palate infants and children is caused by poor eustachian tube function that in turn is caused by anatomical problems in the muscles that open the tube. the investigators plan to test these relationships by studying the changes between 5-24 months and 6 years in middle-ear health, the way the eustachian tube works and eustachian tube anatomy in cleft palate children.

otitis media with effusion (ome) is recognized as nearly universal in the population of infants and children with cleft palate (cp) and is often associated with long-standing conductive and, perhaps, sensorineural hearing losses. most evidence suggests that ome in cp patients is a complication of inefficient eustachian tube function (etf). the investigators plan to use our most complete tests to characterize etf in cp infants tested at age 5-24 months and followed up through age 6 years by yearly collection of clinical data for the presence/absence of ome and repeat etf testing. to obtain anatomical data, the investigators will obtain basal and lateral cephalograms at age 3 years in all subjects and perform mri tests prepalatoplasty when possible and then at 3 and 5 years on a subset of the enrolled children. functional-anatomical reconstructions based on the mri data will be studied for the mechanical interactions underlying the phenomenon of et constriction in cp patients and examined for the possibility of surgical interventions to correct identified abnormal interactions.

Eligibility criteria:
inclusion criteria: * birth-24 months * unrepaired or recently repaired cleft palate exclusion criteria: * cleft palate associated with syndrome * known immune deficiency

Keywords: cleft palate palatoplasty otitis middle ear eustachian tube
efficacy and safety of oral isotretinoin for the treatment of facial recalcitrant flat warts

Conditions: Flat Wart

Summary: randomized clinical trial to compare the efficacy of different doses of oral isotretinoin 10 mg/day, 20 mg/day and 30 mg/day during 12 weeks for the treatment of facial recalcitrant flat warts. the primary endpoint will be the proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial.

the investigators will recruit 162 participants with facial recalcitrant flat warts and randomize to the following three arms of intervention: arm 1: nne capsule of isotretinoin 10 mg plus one capsule of placebo, per day during 12 weeks; arm 2: one capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks; and arm 3: one capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks. the primary endpoints will be the proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial; and the incidence of side effects related to oral isotretinoin treatment among the 3 arms of treatment.

Eligibility criteria:
inclusion criteria: * clinical and histological diagnosis of facial flats warts * more than 2 years with facial flat warts * without response to 2 or more topical interventions (tretinoin, imiquimod, cryosurgery and 5-fluorouracil) or oral interventions (cimetidine or zinc sulfate) exclusion criteria: * have the following conditions: 1. hypercholesterolemia 2. hypertriglyceridemia 3. liver disease 4. renal disease 5. sjögren syndrome 6. pregnancy 7. lactation 8. depressive disorder 9. body mass index less than 18 points or higher than 25 points 10. contraindications for hormonal contraception or intrauterine device.

Keywords: flat wart isotretinoin facial warts
death following congenital heart surgery

Conditions: Congenital Heart Surgery; Congenital Heart Defects

Summary: the purpose of this study is to elucidate the patterns of death following congenital heart surgery.

with the improvements in instrumentation, surgical technique, and critical care, the overall mortality following congenital heart surgery has become extremely low. also, with the introduction of extracorporeal support (ecmo), especially in the emergency setting, acute deaths are extremely rare. the majority of post-operative deaths seem to be the result of a prolonged hospitalization with a progressive decline to multi-system organ failure. the primary aim of the study is to elucidate the patterns of death following congenital heart surgery. the secondary aims of the study are to discover patterns and consistencies among the deaths and to discover points of potential intervention to reduce surgical mortality. the study will be conducted through a retrospective chart review of approximately 40 patients.

Eligibility criteria:
inclusion criteria: * patients in the congenital surgery database * post-operative surgical mortality * deaths within 30 days of surgery * deaths prior to ever leaving the hospital

Keywords: death after heart surgery surgical mortality post-operative mortality pediatric health cardiac
ultrasound-guided nerve blocks for the sciatic and saphenous nerves: characteristics of the single penetration dual injection (spedi) technique

Conditions: Lower Leg Surgery, e.g. Ankle Fractures

Summary: background and aims: ultrasound-guided (usg) nerve blocks of the sciatic nerve (popliteal level = pl) and the saphenous nerve (mid-femoral level = mfl) provides analgesia following leg surgery. traditionally two separate injections are performed. the aim was to describe a novel, faster usg block combination requiring only one skin penetration to block the sciatic and saphenous nerves; i.e. the spedi block = single penetration dual injection. methods: a randomized, controlled and double-blinded trial. following ethics committee approval 60 patients will be randomized to the administration of an usg spedi block compared to two separate usg blocks of the saphenous (mfl) and sciatic (pl) nerves. blocks will be performed after induction of general anaesthesia. outcome measures will be performance time (primary outcome measure), post-anaesthesia care unit pain scores (vas scores 0-10), block difficulty level (easy, middle, difficult), opioid consumption (in the pacu), serum-ropivacaine pharmacokinetics (blood sample 0-180 minutes). both block combinations will be evaluated by mr imaging (mri). hypothesis: the usg spedi block combination is expected to be performed significantly faster without moving the leg, and achieve successful perioperative pain management. the spedi block may find important use in the emergency setting.


Eligibility criteria:
inclusion criteria: * lower leg surgery * american society of anesthesiologist (asa) score i-iii * can cooperate in the study * speaks and understand the danish language * general anesthesia exclusion criteria: * intake of oral morphine above 40 mg per day * know allergy to ropivacaine * abuse of alcohol or other substance abuse * neuropathy * pregnant * nerve block contraindicated

Keywords: nerve blocks ultrasound-guided leg surgery
coblation-tonsillotomy vs electrocautery-tonsillectomy for the treatment of obstructive sleep apnea (osa) in children

Conditions: Obstructive Sleep Apnea

Summary: removal of the adenoid and tonsils, known as an adenotonsillectomy (at) is one of the most frequently performed surgical procedures in north america. the two most prevalent indications for this procedure in children are recurrent bacterial tonsillitis and obstructive sleep apnea (osa). osa is a common childhood condition that is characterized by upper airway obstruction, disturbed sleep and disrupted normal respiratory gas exchange. in the majority of children with osa, overgrowth of the adenoid and tonsils is the primary underlying aetiology, making tissue removal via at the standard of care. the purpose of this study is to evaluate the effectiveness of two different surgical techniques, electrocautery-tonsillectomy and coblation-tonsillotomy, in the treatment of obstructive sleep apnea (osa) in children.


Eligibility criteria:
inclusion criteria: * moderate or severe osa on psg (ahi ≥ 5.0) * pronounced tonsillar hyperplasia on physical exam * no previous tonsil or adenoid surgery * no history of recurrent tonsillitis * participants and their families must be willing to comply with follow-up * parents/caregivers fluent in english exclusion criteria: * severe co-morbidities, including, but not limited to, poorly controlled asthma, chromosomal abnormalities, and developmental delay

Keywords: obstructive sleep apnea osa apnea hypopnea index ahi coblation electrocautery tonsillectomy tonsillotomy
continuous suturing versus interrupted clips for brachiocephalic av fistula creation

Conditions: Arteriovenous Fistula

Summary: the purpose of this study is to investigate a promising strategy to improve maturation and patency rates following creation of av fistulas and assess whether an anastomosis performed with anastoclips (interrupted, nonpenetrating) would produce better maturation and/or patency than one performed with conventional suturing techniques.

this will be a single blind (patient and dialysis center), prospective, randomized trial conducted at a single center. the study intervention will be randomization between conventional sutured anastomosis (control group) and use of anastoclips (treatment group), which provide an interrupted closure without intimal penetration.

Eligibility criteria:
inclusion criteria: * requiring brachiocephalic fistula judged to be best option for access after vein mapping (surgeons will be required to do 10 cases using anastoclips prior to enrolling) * able to provide informed consent in english or spanish * age 18 years or greater * with estimated life expectancy of 2 years or more * able to comply with study procedures including all scheduled follow-up visits exclusion criteria: * unable to provide informed consent in english or spanish * age \< 18 years * with pacemaker, iacd, or other permanent obstructive device on that side (a temporary tunneled dialysis catheter is not an exclusion) * unable (or in surgeon's judgment a poor risk) to comply with study procedures and follow-up visits * with estimated life expectancy of less than 2 years * females must be either: * of non-childbearing potential, which is defined as post-menopausal (at least 12 months without menses prior to treatment day) or documented surgically sterile or post hysterectomy (at least 1 month prior to treatment day) * or, of childbearing potential, in which case must have a negative urine pregnancy test at treatment day