Kornimate/medical-research-clean huggingface dataset:
bacterial cellulose-monolaurin hydrogel for acute radiation dermatitis

Conditions: Acute Radiation Dermatitis

Summary: acute radiation dermatitis (ard) is almost universally experienced by patients with cancer during or after radiation therapy. this condition potebtxallt leads to detrimental clinical outcomes as it adversely affects adherence to prescribed subsequent management and further worsens quality of life. nevertheless, there remains no consensus on the appropriate intervention for ard. this pilot two parallel-group randomized trial aims to clinically assess the potential of bacterial cellulose-monolaurin hydrogel, compared to placebo cream, to prevent high-grade ard among filipinos with breast cancer up to four weeks after last radiotherapy session.


Eligibility criteria:
inclusion criteria: * female sex at birth * age at least 18 years at the time of invitation * eastern cooperative oncology group (ecog) performance status score of either 0 or 1 * with histopathologic diagnosis of breast carcinoma * already completed prescribed mastectomy and chemotherapy (adjuvant or neoadjuvant) interventions * scheduled to receive hypo fractionated postmastectomy-postchemotherapy radiation therapy exclusion criteria: * pregnant or lactating * with concurrent or previous history of any malignancy * with history of mediastinal or thoracic irradiation * with current bilateral synchronous breast carcinoma * with diagnosis of metastases from any form of breast cancer * with any skin lesion in the planned radiation field deemed deramtologically and/or radiotherapeutically relevant * with concomitant disease states deemed clinically significant (connective tissue diseases, infections, uncontrolled chronic disorders, renal failure, hepatic dysfunction, etc.) * with known history of hypersensitivities and/or reactions against any component of either experimental or comparator interventions * inability to personally provide informed consent or to personally comply with skin care instructions

Keywords: ard postmastectomy breast cancer breast adenocarcinoma
efficacy of the multidisciplinary treatment to the quality of life of with functional movement disorders

Conditions: Functional Neurological Disorder; Functional Movement Disorder

Summary: randomized-clinical trial of multidisciplinary approach versus psychoeducation in patients with functional movement disorders: impact to their quality of life and their caregivers' quality of life. patients with functional movement disorders are randomized in two arms of a one-month treatment (physiotherapy + cognitive-behavioral therapy versus psychoeducational as sham intervention) with a 3-month and 5-month follow-up where the investigators will measure the change in the patients' and caregivers' quality of life. movement disorders specialists will review the severity of symptoms as blinded raters in the 3th-month and 5th-month follow-up.


Eligibility criteria:
inclusion criteria: * diagnosis of functional movement disorders (espay and lang, 2015) * patients should be 18 years old or older and capable of giving consent to freely and willingly participate in the study. * patients should be able to attend the one-month ambulatory regime and follow-up visits. exclusion criteria: * any condition that avoid the patient from giving free consent to participate in the study. * any non-controlled psychiatric disorders
proofprincip intratu tcells singldoseimmuncheckpoininhib gastro-esophage adenocarcinoma w/arid1a mu

Conditions: Solid Tumor, Adult; Malignant Solid Tumor; Stomach Adenocarcinoma; Esophageal Adenocarcinoma

Summary: this is a proof of principle clinical trial determining efficacy of single dose dualimmune checkpoint inhibitors to increase intra-tumoral t cells in esophageal, gastroesophageal junction, and gastric adenocarcinomas. these are subjects who have not previously been treated for their disease, who are willing to undergo biopsy procedures, who's disease has not spread to other parts of the body, who's tumors have arid1a mutations.


Eligibility criteria:
inclusion criteria: * non metastatic gec including locally advanced unresectable * treatment naïve * histologically proven adenocarcinoma of the esophagus or the stomach with arid1a mutation either by liquid biopsy (ctdna) or tissue ngs/wes * msi-stable or pmmr * age ≥ 18 years * body weight \> 66 pounds * ecog ≤ 2 * repeat biopsy feasible * no clinically significant autoimmune disease exclusion criteria: * patients with known metastatic disease * prior systemic treatment for esophagus, gej, or the stomach adenocarcinoma * patients with uncontrolled autoimmune disease per investigator discretion * inability or refusal to undergo biopsy procedures to obtain tissue samples
comparative study between hyperbaric therapy and intravesical dimethyl sulfoxide instillation for interstitial cystitis

Conditions: Interstitial Cystitis

Summary: the purpose of this study is to compare the efficacy of hyperbaric oxygen therapy (hbot) to intravesical dimethyl sulfoxide (dmso) instillation for the treatment of patients who suffers from interstitial cystitis / painful bladder syndrome.

interstitial cystitis / painful bladder syndrome (ic/pbs) presents as a pelvic pain condition associated with urinary urgency and frequency. these symptoms impair significantly the patient's quality of life. the etiology is yet not obvious. the current acceptable theory is injury or dysfunction of the mucus (glycosaminoglycans) layer that covers the inner surface of the urinary bladder. abnormal diffusion of toxins from the urine to the walls of the bladder leads to inflammation, pain and scarring. many types of treatments were described but most of them were not evaluated in well designed randomized controlled studies. for now, there is no one single treatment that gives good outcome to every patient. therefore, the treatment of patients with ic/pbs is challenging. in this study, we will compare the efficacy of hyperbaric oxygen therapy (hbot) to intravesical dimethyl sulfoxide (dmso) instillation for the treatment of patients who suffers from ic/pbs. patients with ic (niddk criteria) will be randomized to have either dmso instillation or hbot. before and after treatments the patients will fill out questionnaires (o'leary-sant interstitial cystitis symptom and problem index), visual analogue scale for pain and bladder diaries. in addition, urodynamics will be performed before and after treatments. in case of incomplete symptoms remission, patients will be crossed over to have the other treatment.

Eligibility criteria:
inclusion criteria: * niddk diagnosis of interstitial cystitis exclusion criteria: * previous treatment of hyperbaric therapy * contraindication for hyperbaric therapy (mid-ear pathology, abnormal chest x-ray, claustrophobia, pregnancy

Keywords: interstitial cystitis painful bladder syndrome chronic pelvic pain dmso hyperbaric oxygen therapy
driving simulator study comparing two modes of presbyopic correction with contact lenses

Conditions: Presbyopia

Summary: the overall objective of this study is to compare the effect on simulated driving performance of multifocal (mf) versus monovision (mv) soft contact lenses in mid-late presbyopes.

in this crossover study, subjects wore lotrafilcon b mv (aoamv) and lotrafilcon b mf (aoamf) soft contact lenses as randomized for 2 weeks each. subjects were assessed using a standardised driving simulation for each of the two treatments. a fresh pair of lenses was dispensed for the assessment. subjects also wore lotrafilcon b single vision distance (svd) and comfilcon a mf contact lenses during period 1 and period 2 respectively for an additional same-day assessment. habitual correction was worn for an acclimatization drive in the driving simulator during period 1.

Eligibility criteria:
inclusion criteria: * current soft contact lens wearers (for 1 month or more) with distance spherical power requirements of +1.00 to + 4.00 diopters (d) or -1.00 to -10.00d, and who have never tried and then failed in monovision or aoamf. * medium to high presbyopia, i.e. spectacle add requirement of +1.50d or more. * astigmatism, if present, ≤1.00d in both eyes. * distance visual acuity (va) correctable to 20/30 (+0.2 logmar) in both eyes. * within the normal ranges for binocular vision for distance (8δ exophoria, ≤8δ esophoria), vertical phoria = 1.5δ hypo or hyper. * full united kingdom driving license held for at least 3 years, with at least 2000 miles driven per year. * willing to wear study lenses at least 5 days per week. * other protocol-defined inclusion criteria may apply. exclusion criteria: * existing air optix® multifocal cl user. * sphere requirement in the range +0.75 to -0.75d in both eyes. * previous refractive surgery. * ocular/systemic medical condition or medical treatment contra-indicating contact lens wear or driving simulation. * participation in a clinical study within the past 30 days. * other protocol-defined exclusion criteria may apply.

Keywords: driving simulator air optix aqua aoamf
prevention of neonatal respiratory distress syndrome with antenatal steroid administration

Conditions: Lung Diseases; Respiratory Distress Syndrome

Summary: to determine the effect of corticosteroids, administered 24 to 48 hours before parturition, on the incidence of neonatal respiratory distress syndrome (rds) and to determine whether the therapy has any adverse short- or long-term (up to 36 months) effects on the infant. secondarily, to determine whether the therapy has any adverse short-term effects on the mother and to determine whether morbidity rates for neonatal respiratory distress syndrome as well as total and cause-specific infant mortality rates differ between mothers who received antenatal steroids and those who received conventional medical care.

background: neonatal respiratory distress syndrome is one of the leading causes of disability and death in the newborn. in the united states, approximately 10 percent of all infants are premature, and each year about 50,000 cases of neonatal respiratory distress syndrome occur. extensive studies in animal models on respiratory distress syndrome have demonstrated that antenatal administration of synthetic (dexamethasone) and natural (cortisol) corticosteroids accelerates lung maturation and significantly diminishes the occurrence of rds. although a variety of conditions in newborn infants have been treated with steroids over the past 20 years without adverse effects, investigations have been needed on the short-term effects of corticosteroids administered antenatally on neonate and mother and on the long-term effects on the infant. the planning phase of this trial was completed in march 1977, with formulation of a common protocol and manual of operations. patient screening and enrollment began in august 1977 and ended on march 1, 1980. follow-up ended in august 1983 and data analysis was completed october 31, 1983. design narrative: randomized, double-blind, fixed sample. six hundred and ninety-six pregnant women were randomized to four doses of dexamethasone every 12 hours or to placebo. endpoints were the incidence of respiratory distress syndrome and abnormality of motor-neuro-intellectual development in their infants.

Eligibility criteria:
male and female fetuses and infants; pregnant women with anticipated premature delivery and gestational age between 26 and 37 weeks.
post-market registry of auryon™ atherectomy device in subjects affected with infrainguinal peripheral artery disease

Conditions: Infrainguinal Peripheral Artery Disease; Peripheral Arterial Disease; PAD

Summary: the pathfinder i registry is a prospective, non-randomized, single arm, multicenter observational study. it is a pilot registry study towards a subsequent large pivotal phase registry. this pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term) of the auryon™ atherectomy system, within the initial launch phase of the product in the market.

us multicenter, prospective, single-arm, observational post market registry. a pilot registry towards a subsequent large pivotal registry (pathfinder ii), aimed to evaluate the safety and efficacy of auryon™ atherectomy system in the treatment of de novo, re-stenotic and isr lesions in infra-inguinal arteries of peripheral artery diseases (pad) subjects, in a real-world setting within the initial launch phase of the product in the market.

Eligibility criteria:
inclusion criteria: 1. subject is ≥ 18 years old. 2. subject is a candidate for atherectomy for infra-inguinal peripheral artery disease. 3. documented symptomatic atherosclerotic peripheral artery disease with claudication or critical limb ischemia (cli) (rutherford classification 2-5 ). 4. subject is capable and willing to comply with the scheduled follow up 5. subject is able and willing to sign a written informed consent form (icf). exclusion criteria: 1. target lesion is in an arterial bypass. 2. planned use of another atherectomy device in the same procedure 3. co-morbid condition(s) with less than 1yr anticipated survival that could limit the subject's ability to participate in the trial or to comply with follow-up requirements or impact the scientific integrity of the study. 4. participating in another study on an interventional non-cleared device, that could impact the study results

Keywords: peripheral artery disease peripheral occlusive disease peripheral artery stenonsis artery restenosis arterial occlusive disease peripheral vascular disease laser recanalization endovascular treatment or procedure or surgery calcified lesions atherectomy intermittent claudication claudication pain arterial calcification critical limb ischemia cli acute limb ischemia acute arterial occlusion infra-inguinal stenosis or occlusion femoral artery stenosis femoral-popliteal arterial disease tibial stenosis in-stent restenosis stenotic lesion peripheral artery revascularization lower limb arterial calcification laser-assisted angioplasty above the knee calcification atk calcification below the knee calcification chronic total occlusion cto superficial femoral artery disease target lesion revascularization atherectomy catheter observational study registry walking impairment questionnaire intravascular ultrasound ankle-brachial pressure index toe-brachial index rutherford classification abi tbi peak systolic velocity ratio auryon system eximo medical angiodynamics b-laser real world evidence
a randomized study of xen1101 versus placebo in focal-onset seizures

Conditions: Focal Onset Seizures

Summary: the x-tole2 phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of xen1101 administered as adjunctive therapy in focal-onset seizures.

approximately 360 subjects will be randomized in a blinded manner to one of two active treatment groups or placebo in a 1:1:1 fashion (xen1101 25 mg : 15 mg : placebo). eligible subjects will have up to 9.5 weeks of baseline to assess frequency of seizures, followed by 12 weeks of blinded treatment. in order to be included in the study, subjects must be treated with a stable dose of 1 to 3 allowable antiseizure medications (asms) for at least one month prior to screening, during baseline, and throughout the double-blind treatment period (dbp) of the study. during the dbp, subjects will be instructed to orally take xen1101 or placebo once daily with an evening meal. subjects who complete the 12-week dbp will have the opportunity to qualify and enroll in a separate open-label extension (ole) study for continued treatment with xen1101. subjects who do not enroll in the ole will enter a 8-week post treatment follow-up period.

Eligibility criteria:
inclusion criteria: * be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study * diagnosis (≥2 years) of focal epilepsy according to the international league against epilepsy (ilae) classification of epilepsy (2017). subject must have had adequate trials of at least 2 asms, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom. * treatment with a stable dose of 1 to 3 allowable current asms for at least one month prior to screening, during baseline, and throughout the duration of the dbp * able to keep accurate seizure diaries exclusion criteria: * previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures. * history of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including lennox-gastaut syndrome. * seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (cns) disease. * history of status epilepticus or repetitive seizures within the 12-month period preceding visit 1 where the individual seizures cannot be counted. * history of neurosurgery for seizures \<1 year prior to visit 1, or radiosurgery \<2 years prior to enrollment. * any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.

Keywords: epilepsy
efficacy and safety of different initial doses of oral propranolol in the treatment of ulcerated infantile hemangioma

Conditions: Infantile Hemangioma

Summary: the main objective of this study was to determine the efficacy of different doses of propranolol in the treatment of ulcerattion infantile hemangioma (ih).

infantile hemangioma (ih) is the most common benign tumor in infants, with an estimated prevalence of 4%-5%. although most ih resolves over time without serious sequelae, a significant proportion can lead to serious complications such as ulcers. propranolol is considered to be an effective treatment modality for ulceration ih, and there are retrospective studies suggesting that starting treatment at a low dose is safe and effective. however, due to the lack of prospective study, the effectiveness of different doses of propranolol for initiating treatment of ulceration ih is unknown. therefore, a prospective study of ulceration ihs in chinese children was conducted to clarify its efficacy.

Eligibility criteria:
inclusion criteria: 1. all patients with ulcer ih; 2. children with ulcer ih treated with propranolol. exclusion criteria: 1) children with ulcer ih who received other therapeutic interventions were excluded; 2) children whose families refused to participate in the study; 3) patients with contraindications to oral propranolol, such as allergy to propranolol, severe bradycardia and bronchial asthma; 4) children lost to follow-up during oral propranolol treatment; 5) children unable to oral propranolol or continue to oral propranolol due to other reasons. -

Keywords: infantile hemangioma, ulcer, propranolol
effect of preoperative mri virtual reality in patients undergoing knee arthroscope surgery

Conditions: Knee Injuries

Summary: knee mri is difficult for patients to understand as the image offers a single plane image. accordingly,investigators sought to transfer the mri image to 3-dimensional virtual reality system by mesh rendering technique.

the primary outcome of the study is apais score assessed at 24 hours postoperation. experimental vr group will be applied with virtual reality transformed knee mri whereas no interverntion group will be applied with traditional knee mri. mri will be transformed to virtual reality images by mesh rendering technique.

Eligibility criteria:
inclusion criteria: * undergoing elective knee arthroscopy surgery exclusion criteria: * infection, not willing to undergo study, mentally ill, severe osteoarthritis (kl grade iii or more)

Keywords: virtual reality knee
cognitive complaints in obstructive sleep apnea

Conditions: Cognition Disorders; Sleep Apnea Syndromes, Obstructive

Summary: the study assesses cognitive complaints in newly diagnosed patients with obstructive sleep apnea with no medical-comorbity affecting cognition. cognitive complaints will be compared to healthy controls matched on age, sex and educational level. factors related to cognitive complaints will also be assessed, including anxiety and depressive symptoms, complaints of fatigue and sleepiness, quality of life, psychological coping strategies and objective measures of cognition. patients starting treatment for sleep apnea (continuous positive airway pressure or mandibular repositioning device) will be reassessed on all measures after 6 months of treatment to study the impact of treatment as usual on cognitive complaints and its related factors.


Eligibility criteria:
inclusion criteria: * native dutch speaker * estimated verbal-iq of ≥80 exclusion criteria: * other sleep disorder than obstructive sleep apnea * substance or alcohol abuse (e.g. no more than three units of alcohol per day for males and no more than two units of alcohol per day for females * diagnosis of a psychiatric disorder * use of medication effecting cognition * neurological disease, diabetes mellitus, hypo- or hyperthyroidism or lung disease (as checked by verbal report and medical records)
immunogenicity & safety study of combined/separate vaccine(s) against common diseases in infants (2,4,6 months of age).

Conditions: Poliomyelitis; Tetanus; Acellular Pertussis; Hepatitis B; Diphtheria

Summary: this study will evaluate the immunogenicity of the co-administration of different combinations of dtpa, ipv, hepatitis b, hib and men c vaccines during the first year of life.


Eligibility criteria:
inclusion criteria: * healthy male or female infant between, \& including, 0 \& 7 days of age at the time of the inclusion. born after a normal gestation period (between 36 \& 42 weeks). * written informed consent obtained from the parent/guardian of the subject. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned use during the study period. * administration of immunosuppressants or other immune-modifying drugs from birth. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * administration / planned administration of a vaccine not foreseen by the study protocol during the period starting from birth and ending 30 days after the last dose except bcg vaccination if given before the 30-day period preceding the administration of the 1st dose of infanrix penta™ or infanrix hexa™ in combination with a meningococcal c vaccine. * evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis b, meningococcal c and hib disease. * evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis b, meningococcal c and hib vaccination.

Keywords: open, phase 3, infanrix hexa™, hib-menc, co-administered