Kornimate/medical-research-clean huggingface dataset:
topical imiquimod for bowen's disease of the head and neck

Conditions: Bowens Disease

Summary: * double blinded, randomized, placebo controlled trial of imiquimod for the treatment of histologically proven bowens disease of the head and neck. * null hypothesis: no difference in histologic clearance rates of patients with head or neck bowens treated with imiquimod versus placebo. * outcome: histologic clearance of bowens disease at t=14 weeks.

interventional study enrolling inclusion criteria: military beneficiaries with histologically proven bowens disease, located on the head and neck, defined as any area superior to the clavicle and anterior to the posterior triangle of the neck exclusion criteria: * previous treatment of biopsied lesion recurrent lesions from previous biopsy-proven bowen's disease * patients younger than 18 years of age * pregnancy * immunosuppression, including hiv, transplant patients on immune suppressive medications, cancer patients on chemotherapy, and hematologic malignancies (e.g., lymphoma, leukemia) * mucous membrane involvement * lesions larger than 2 cm * methods: pts randomized to treatment group (6 weeks of mon-friday imiquimod to bowens site) or vehicle group (same treatment regimen). all patients undergo surgical excision (mohs or simple excision) of site where disease is either visible or was present and tissue examined for histologic evidence of residual bowens disease

Eligibility criteria:
inclusion criteria: * histologic diagnosis of bowen's disease (squamous cell carcinoma in situ), defined as full-thickness keratinocyte atypia and architectural disorder limited to the epidermis, with or without involvement of the follicular unit * located on the head and neck, defined as any area superior to the clavicle and anterior to the posterior triangle of the neck * primary bowen's disease (first diagnosis) exclusion criteria: * previous treatment of biopsied lesion * recurrent lesions from previous biopsy-proven bowen's disease * patients younger than 18 years of age * pregnancy * immunosuppression, including hiv, transplant patients on immune suppressive medications, cancer patients on chemotherapy, and hematologic malignancies (e.g., lymphoma, leukemia) * mucous membrane involvement * lesions larger than 2 cm

Keywords: bowens disease squamous cell carcinoma in situ of the skin imiquimod
periodic versus continuous iv iron supplementation in hd patients

Conditions: Anemia of Chronic Kidney Disease

Summary: the purpose of this study was to compare the efficacy of two regimens of intravenous iron sucrose \[continuous (in every hemodialysis session) versus intermittent (every 1-4 weeks)\] on the response of rhuepo in the maintenance phase of its administration in hemodialysis patients.


Eligibility criteria:
inclusion criteria: * constant rhu-epo and iron dose for at least 2 months before starting the study * hemoglobin ≥ 8,5g/dl and \<12,5 g/dl * ferritin \< 1000 mg/dl * tsat \< 50% * crp \< 5 mg/dl exclusion criteria: * malignant tumor disease * oral iron supplementation * active bleeding issues * surgical intervention within the last 8 weeks before study inclusion

Keywords: iron deficiency hemodialysis
time outside target oxygen saturation range in preterm infants and long term outcomes and preterm infants

Conditions: Retinopathy of Prematurity

Summary: the purpose of this study is to determine if there is a relationship between time spent out the targeted oxygen saturation range in preterm infants is associated with long-term outcomes such as retinopathy of prematurity.

all infants who had a birth weight of less than 1500 grams or less than 32 weeks gestation admitted to our neonatal intensive care unit (nicu) were eligible for the study. all infants were placed on nellcor n600 pulsoximetry. saturation data in two-second sampling from n600 oximax pulse oximeters (covidian, ca) was collected using a modified nellcor® oxinet® iii system (covidian, ca and cardiopulmonary, milford, ct) alarm limits were set at 83% and 93% while infants required oxygen supplementation and 85% to 100% when neonates were in room air. desaturation events were defined as number of times the saturation fell below the low saturation limit set on the monitor (83% if oxygen requirement \>21%, 85% if patient on room air). high saturation events were defined as the number of times the patient's saturation was above the upper saturation limit (93% if oxygen requirement \>21%) the data collection system summarized each day in tabular form including average spo2, number of low and high spo2 events, duration of events in minutes, and the percentage of time infants spent outside of the intended saturation range. primary outcome was threshold rop requiring laser ablation. data on rop was collected during hospitalization and after discharge until resolution of rop by pediatric ophthalmologist blinded to the study results. secondary outcomes included bronchopulmonary dysplasia, length of hospitalization, sepsis, focal bowel perforation, necrotizing enterocolitis (stage 2 or greater), patent ductus ligation, intracranial hemorrhage, and number of red blood cell and platelet transfusions.

Eligibility criteria:
inclusion criteria: * preterm infants \<1500 grams or \<32 weeks gestation exclusion criteria: * none

Keywords: oxygen saturation retinopathy of prematurity long term outcomes hypoxia hyperoxia
a controlled trial of erenumab in migraine prevention

Conditions: Migraine

Summary: the purpose of this study was to assess the efficacy and safety of erenumab for prevention of migraine in japanese adults with episodic migraine (em) and chronic migraine (cm).

migraine prevention is an area of a large unmet medical need, with existing therapies often having modest efficacy and poor tolerability. calcitonin gene-related peptide (cgrp) receptor antagonism is a novel approach to migraine preventive therapy. erenumab is a human monoclonal antibody against canonical cgrp receptor. the present study is a phase 3 trial intended to assess the efficacy and safety of erenumab for prevention of migraine in japanese adults with episodic migraine (em) and chronic migraine (cm). the study consists of a screening period (up to 7 weeks, including a 4-week baseline period), a 24-week double-blind treatment period (dbtp), a 28-week open-label treatment period (oltp), and an 8-week safety follow-up period (12 weeks after the last dose of investigational product).

Eligibility criteria:
inclusion criteria: * subject has provided informed consent/assent prior to initiation of any study specific activities/procedures. * japanese subjects greater than or equal to 20 to less than or equal to 65 years of age upon entry into screening. * history of migraine (with or without aura) for greater than or equal to 12 months before screening according to the international headache society classification ichd-3 (headache classification committee of the international headache society, 2018) based on medical records and/or patient self-report * migraine frequency: chronic migraine (cm) or episodic migraine (em) over the 3 months before screening based on the following criteria: 1. cm is defined as greater than or equal to 15 headache days per month of which greater than or equal to 8 headache days on average across the 3 months meet criteria as migraine days 2. em is defined as less than 15 headache days per month of which at least 4 or more headache days on average across the 3 months meet criteria as migraine days exclusion criteria: * subjects greater than 50 years of age at migraine onset. * history of cluster headache or hemiplegic migraine headache. * unable to differentiate migraine from other headaches. * migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period. * malignancy, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years. other exclusion criteria may apply
safety and efficacy study of a new treatment for recurrent symptoms of oral herpes virus infection

Conditions: Oral Herpes Simplex

Summary: the purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.


Eligibility criteria:
inclusion criteria: * clinical history of recurrent cold sores averaging 2 or more episodes per year * experiences prodromal symptoms (tingling, burning, itching) of cold sores * herpes simplex virus seropositive (by blood test) exclusion criteria: * immuno-suppressed or taking immunosuppressant medication * use of antiviral therapy directly prior and during the study

Keywords: herpes labialis herpes simplex herpes
tme neoadjuvant breast registry

Conditions: Breast Cancer; Breast Neoplasms

Summary: prospective observational registry that links results of the genomic and other molecular testing to treatment response and survival measures in patients who have been diagnosed with breast cancer and who are targeted for neo-adjuvant therapy. analysis includes how tests impact treatment decisions and outcomes.

physicians will order tests on patients as part of standard of care; they will report whether test results influenced: selection between standard therapies or a clinical trial; offered insight into mid therapy treatment changes; or helped physicians determine what therapy to offer patients who do not have a complete pathologic response. patient demographics, diagnosis, type of treatment, surgery and pathologic results will be recorded. patients will be followed for 5 years. recurrence and survival data will be recorded. participating sites will submit de-identified patient data via electronic case report forms (ecrfs) into a secure study website. all patients are required to sign an informed consent form. all investigators and staff will have human subject protection training.

Eligibility criteria:
inclusion criteria: * patients with histologically proven invasive breast cancer who have started or are scheduled to start neo-adjuvant chemotherapy or endocrine therapy * ages 18-90 * written informed consent exclusion criteria: * patients who have had excisional biopsy or axillary dissection * patients with confirmed metastatic disease * patients who have had recent chemotherapy

Keywords: breast cancer neoadjuvant therapy for breast cancer
a study to assess adverse events, how the drug moves through the body and effectiveness of intravenous infusions of abbv-319 in adult participants with systemic lupus erythematosus (sle) and sjogren's disease (sjd)

Conditions: Dry Eye Syndrome; Systemic Lupus Erythematosus

Summary: systemic lupus erythematosus (sle) is a chronic, systemic autoimmune disease characterized by b cell hyperactivity and sjorgren's disease (sjd) is a chronic, multisystem autoimmune disease characterized by lacrimal and salivary gland inflammation, with resultant dryness of the eyes and mouth and occasional glandular enlargement. abbv-319 exhibits potential b cell depletion in sle and sjd which are characterized by b cell hyperactivity. the purpose of this study is to assess the pharmacokinetics, safety, and efficacy of abbv-319 in adult participants with sle or sjd. abbv-319 is an investigational drug being developed for the treatment of sle and sjd. participants are placed in 1 of 6 groups called treatment arms. each group receives a different dose of abbv-319 depending on whether they have sle or sjd. around 36 adult participants with sle or sjd will be enrolled at approximately 10 sites worldwide. participants will receive 2 doses of iv abbv-319 21 days apart and will be followed for up to 343 days. there may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * systemic lupus erythematosus (sle) population - clinical diagnosis of sle at least 6 months prior to screening as defined by the 2019 european alliance of associations for rheumatology (eular)/american college of rheumatology (acr) classification criteria for sle and a positive antinuclear antibody (ana) \>= 1:80 drawn at screening. * sle population - presence of anti-double stranded dna (dsdna), anti-smith (sm), anti-ribonucleoprotein (rnp), or anti-sjogren's syndrome ag a (ssa) abs above the upper limit of normal (uln). * sjogren's disease (sjd) population - primary diagnosis of sjd at least 6 months prior to screening as defined by the acr/eular 2016 criteria. * sjd population - eular sjogren's syndrome disease activity index (essdai) \>= 5 at screening. * sjd population - eular sjogren's syndrome patient reported index (esspri) \>= 5 at screening. exclusion criteria: * history of infection as defined in the protocol. * any of the medical diseases or disorders listed in the protocol. * history of clinically significant (per investigator's judgment) drug or alcohol abuse within the 6 months prior to screening. * any planned elective surgery that would impact study procedures or assessments through the completion of the day 365 assessments. * any clinically significant ecg abnormalities at screening.

Keywords: dry eye syndrome systemic lupus erythematosus abbv-319
supplemental adjuvants for intracellular nutrition and treatment

Conditions: Neovascular Age-related Macular Degeneration; Diabetic Macular Edema

Summary: nutritional supplements have an augmentative effect on the outcomes of standard treatment of diabetic macular edema (dme) and neovascular age-related macular degeneration (namd).

it has been shown that in chronic diseases, oxidative stress results from nitric acid reacting with oxygen to form toxins that damage both somatic and mitochondrial dna. the potential for protecting the dna and promoting repair by using nutritional supplements will be tested by augmenting standard treatments for dme and namd with such supplements. the patients will be randomized to treatment group and placebo group and followed up for a year in a double masked fashion. anatomic and visual outcomes, as well as side effects will be assessed and analyzed. if the results are promising, this pilot study can be used to design alternative (cheaper, better and longer lasting) treatments for dme, namd and perhaps other chronic illnesses.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of namd * clinical diagnosis of dme exclusion criteria: * pregnant women * known allergy to any component used in the treatment combinations

Keywords: dme namd oxidative damage nutritional supplements/vitamins dna repair namd/wet amd
neurophysiological evaluation of residual cognitive functions in patients with severe alterations of consciousness

Conditions: Consciousness Disorder; Cognitive Impairment

Summary: identify potential markers of recovery through event-related potentials (erps) in the evolution of altered consciousness with potential ability to discriminate between different conditions of altered state of consciousness. identify potential markers with prognostic value, in order to identify personalized and specific intensive rehabilitation paths based on the outcome indexes obtained.


Eligibility criteria:
inclusion criteria: * glasgow coma scale (gcs) \> 8; level of cognitive scale (lcf) = 1-3; signature of the consent from the family member and/or guardian. exclusion criteria: * failure to sign the consent of the family member and/or legal guardian; patients with cranial anatomical alterations that do not allow the correct assembly of the electrodes, caps, etc.; patients with absence of neurophysiological responses in visual evoked potentials (vep) and with absence of peripheral waves (i-ii wave) to acoustic potentials (pea).
opportunities for antibiotic optimisation and outcomes improvement in patients with negative blood culture (no-bact)

Conditions: Antibiotic Resistant Infection

Summary: patients with negative blood cultures represent 85-90 % from all patients with a blood culture taken during hospital admissions. this population usually includes an heterogeneous group of patients that are admitted because of an infectious diseases or febrile syndrome in which performing a blood culture is required. there is scarce evidence about the clinical characteristics and the antibiotic treatment given to these patients. this project will be developped in two phases with an specific target in each one: * phase i (a cohort study of patient with blood cultured taken): the investigators aim to analyse the clinical and therapeutics characteristics, outcomes and antimicrobial stewardship oppotunities in a population of patients with negative blood culture. the investigators aim to compare the outcomes and antimicrobial stewardship opportunities with those in patients with positive blood culture. * phase ii: the investigators will develop a cluster randomised control trial to evaluate the implementation of a targeted antimicrobial stewardship intervention in patients with negative blood culture (based on 3rd and 5th day audits). the effect of the intervention on the quality of antimicrobial use (duration and de-escalation), long of stay and mortality will be analysed.


Eligibility criteria:
inclusion criteria: * health professionals in charge of patients with negative hemoculture and active antibiotherapy within 48 hours of extraction; and that belong to a clinical unit that has been assigned to the intervention arm. exclusion criteria: * health professionals in charge of patients who, even if they meet the criteria described above, will not be considered to have a foreseeable death within \<72hrs from the hemoculture extraction or a positive hemoculture in the seven days prior to the extraction of the negative hemoculture.
a multi-centre study to assess the long-term performance of the silent hip™ in primary total hip replacement surgery

Conditions: Primary Arthritis; Secondary Arthritis

Summary: the purpose of this study is to monitor the performance and of the silent hip™ in the treatment of patients with hip joint disease requiring a total hip replacement. patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Eligibility criteria:
inclusion criteria: * any subject deemed suitable to receive the silent™ hip in combination with the pinnacle™ acetabular cup system, in accordance with all applicable instructions for use, should be considered for entry into this study. exclusion criteria: * subjects who, in the opinion of the investigator, have an existing condition/co-morbidity or infection that would compromise their long-term participation and follow-up in this study.

Keywords: hip replacement femoral component
effects of hip abductors strengthening in knee osteoarthritis

Conditions: Osteoarthritis Knees Both

Summary: the aim of my study is to determine the effects of hip abductors strengthening and quadriceps strengthening in comparison with quadriceps strengthening alone in patients with knee osteoarthritis.

as the quadriceps strengthening is a keystone of exercise therapy for knee osteoarthritis. thus is the hip abductors strengthening along with quadriceps strengthening would be added to the treatment protocol of osteoarthritis it might give more positive results, decrease pain and increase the recovery rate as well as helpful to improve the functional outcomes.

Eligibility criteria:
inclusion criteria: * osteoarthritis of single or both knees * kellgren lawrence scale between 2-4 exclusion criteria: * knee valgus or varus deformity * hip or knee joint replacement * tibial osteotomy * any other surgery of hip or knee joint
assessing manual acupuncture's impact on mucositis from nasopharynx cancer radiotherapy: a visual analogue scale (vas) and quality of life study

Conditions: Cancer; Nasopharyngeal Carcinoma; Mucositis

Summary: the goal of this clinical trial is to learn if acupuncture can play a role in reducing pain and improving the quality of life of post-radiotherapy nasopharyngeal cancer mucositis patients. the main questions it aims to answer are: - do manual acupuncture and medication therapy affect pain intensity as measured by the visual analogue scale (vas) in patients with oral mucositis compared with sham manual acupuncture and medication? participants will receive acupuncture therapy 2 times a week for 3 weeks

this is a clinical trial study to evaluate the role of acupuncture in pain relief and improving the quality of life of nasopharyngeal cancer patients with post-radiotherapy mucositis. participants were 30 men/females with mucositis in post-radiotherapy nasopharyngeal cancer aged 19-59 years. they will be divided into 2 groups: (1) verum acupuncture and (2) sham acupuncture. acupuncture is scheduled 2 times per week for 3 weeks. research assessment on pain scale and improvement in quality of life

Eligibility criteria:
inclusion criteria: * subjects who have been proven by anatomical pathology examination to have a diagnosis of nasopharyngeal cancer. * subjects with adult nasopharyngeal cancer aged 19 years - 59 years. * nasopharyngeal cancer patients, who underwent bilateral head and neck radiotherapy. * patients diagnosed with mucositis. * willing to participate in the research until completion by signing an informed consent. exclusion criteria: * nasopharyngeal cancer patients who have distant metastases (based on the tumor node metastasis (tnm) classification with the presence of metastases (m1)). * subjects who still smoke and consume alcohol to date. * patients have contraindications for manual acupuncture, namely the use of anti-coagulant drugs, the presence of infection or wounds at the puncture site, emergency conditions, and pregnancy. * there is a history of allergy to stainless steel materials. * patients with blood clotting disorders; platelets \ 2.47
the effects of extraoral photobiomodulation on the rate of orthodontic alignment

Conditions: Malocclusion

Summary: the aim of this study is to determine if extraoral orthopulse®, which emits extraoral led (light emitting diode) photobiomodulation (pbm), reduces the time it takes to complete orthodontic alignment.


Eligibility criteria:
inclusion criteria: * permanent dentition * class i malocclusion with irregularity score of greater than 2 mm in either arch * good oral hygiene exclusion criteria: * any medical or dental condition that could potentially affect study results * patients currently using any investigational drug or any other investigational device * patients planning to relocate or move during the treatment period * use of bisphosphonates * pregnant females

Keywords: alignment phase photobiomodulation orthodontic treatment malocclusion orthopulse™