Kornimate/medical-research-clean huggingface dataset:
evaluation of topical mitomycin c as adjuvant drug to esophageal dilation in children

Conditions: Esophageal Stricture; Caustic Esophageal Stricture; Peptic Esophageal Stricture; Post-Surgical Esophageal Stricture

Summary: this study aims to evaluate mitomycin c as an adjunct to endoscopic treatment of esophageal strictures. this is a crossover, controlled, clinical trial in which children with esophageal stricture will be randomized in two groups to receive either topical mitomycin or no additional treatment during standard esophageal dilation session.

topical mitomycin c has been used as an adjunct drug to endoscopic treatment of aero-digestive strictures. there has been some case reports and case series of this application in esophageal strictures in children, with good results. nevertheless, it lacks a controlled clinical trial to access the efficacy of the mitomycin c in this context. this study aims to evaluate mitomycin c as an adjunct to endoscopic treatment of esophageal strictures. this is a crossover placebo-controlled single-blind clinical trial. patients: subjects up to 18 year-old, with esophageal stricture requiring endoscopic dilation, either due to dysphagia or by stricture preventing passage of the endoscope. inclusion criteria: * peptic esophageal stricture * post-surgical esophageal stricture * caustic esophageal stricture the patient will be randomized by one treatment group, either a or b. * a. during the first endoscopic procedure it will be applied of topical mitomycin c over the esophageal mucosa after dilation, then the second procedure (in two weeks) will be performed as a standard dilation, without mitomycin c. * b. the first procedure will be performed in a standard way, and after two weeks, in the second procedure mytomicin-c will be spread over the esophageal mucosa. the allocation will not be informed to the patient. at the end of the study protocol, the patients will be clinically evaluated and the dilation program will continue on discretion of the assistant doctor. the target esophageal bore is 11 mm (or 12.8 mm if age above 5 yrs). mitomycin c will be applied over the esophageal mucosa in the site of stricture after dilation with a cotton pledget soaked in solution (0.4mg/ml) by three minutes. the pledget will he held over the mucosa with a biopsy forceps. clinical evaluation. dysphagia will be evaluated by a structured questionnaire, using a likert scale. the patient will answer the questionnaire daily. main outcome measure: number of days with improved symptom (dysphagia) after a session.

Eligibility criteria:
inclusion criteria: * children with esophageal strictures * and dysphagia * or stricture preventing endoscope to pass over it. exclusion criteria: * congenital esophageal stricture * stricture associated to eosinophilic esophagitis

Keywords: esophageal stricture
rituximab-induced pulmonary function changes

Conditions: Rheumatoid Arthritis; Inflammatory Myositis

Summary: measuring lung function (fvc, fev1, dlco) before, during and after treatment with rituximab in patients with rheumatoid arthritis or inflammatory myositis.

the objective of this study is to investigate whether rituximab (rtx), a drug commonly prescribed in patients with rheumatoid arthritis (ra) or inflammatory myositis, is associated with subclinical interstitial lung disease (ild). surrogate markers for interstitial lung diseases are a decrease of the forced vital capacity (fvc) and/or the diffusing capacity of the lung for carbon monoxide (dlco). however, the measurement of these lung function parameters is indicated as regular follow-up examinations during the treatment with rtx according to the principles of "good clinical practice". we will perform pulmonary function testing (spirometry) including measurement of the dlco in patients with ra, who are going to be treated with rtx. a baseline lung function measurement will be performed immediately before rtx therapy is started. follow-up measurements will be performed at 2 weeks, 4 weeks, 8 weeks and 6 months after initiation of rtx therapy. a reduction in forced vital capacity (fvc) of \>10% or a fall of \>15% in dlco will be defined as indicative for ild.

Eligibility criteria:
inclusion criteria: - patients with established diagnosis of ra or inflammatory myositis, in whom a de novo rtx treatment is indicated * age \>18 y * informed consent of patient exclusion criteria: - acute infection * pre-existing interstitial pulmonary disease * patients with impaired forced vital capacity (fvc) on spirometry (\<80% predicted) or with impaired dlco (\<75% predicted). * pregnancy
optimal pharmacological therapy for patients with heart failure: the optipharm-hf registry

Conditions: Heart Failure

Summary: prospective, observational, multicenter, national study of adult patients with hf to assess prescription and adherence to evidence-based guideline-directed medical therapy (gdmt) in patients with heart failure (hf).

prospective, observational, multicenter, national study designed to evaluate the care and outcomes of patients with hf, to understand reasons for lack of implementation of evidence-based treatment and the impact of adherence to treatment on clinical outcomes in patients with hf across the full spectrum of left ventricular ejection fraction (lvef). the study will enroll consecutive patients with symptomatic hf, aged ≥ 18 years from at least 30 italian tertiary hf care centers. both outpatients and in-patients with chronic and acute decompensated hf will be consecutively recruited. patients will be followed for a maximum duration of 24 months.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old * signed patient informed consent form (icf) * diagnosis of chronic or acute decompensated hf according to esc guidelines and the universal definition of hf. * receiving at least one drug for management of hf at study enrollment (including diuretics, β-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, aldosterone antagonists). exclusion criteria: * planned participation or participation in a clinical trial; * life expectancy \< 1 year because of non-cardiac causes; * previous heart transplant or left ventricular assist device implantation.

Keywords: gdmt hfref hfpef clinical outcomes
low molecular weight heparin vs. aspirin post-partum

Conditions: Venous Thromboembolism

Summary: this is single centre pilot, randomized controlled trial assessing postpartum prophylactic anticoagulation with 3 weeks of lmwh followed by 3 weeks of aspirin compared to standard of care of prophylactic lmwh for 6 weeks at moderate to high risk of developing vte.

a single centre pilot, randomized controlled trial assessing postpartum prophylactic anticoagulation with 3 weeks of lmwh followed by 3 weeks of aspirin compared to standard of care of prophylactic lmwh for 6 weeks for women at moderate to high risk of developing vte to determine feasibility of conducting a large non inferiority trial using the same regimens.

Eligibility criteria:
inclusion criteria: 1. personal history of unprovoked vte prior to pregnancy or hormone associated vte and not prescribed therapeutic anticoagulation or 2. family history (1st degree relative) of vte and antithrombin deficiency, protein c or protein s deficiency or 3. combined thrombophilia or homozygous for the factor v leiden mutation or prothrombin gene mutation, and family history of vte (1st degree relative) and 4. \> 18 years of age. exclusion criteria: 1. pre-existing indication for therapeutic lmwh 2. contraindication to asa: 1. known asa allergy 2. documented history of gastrointestinal ulcer 3. known platelet count \< 50x10\^9/l at any time during the current pregnancy or postpartum 3. contraindication to lmwh, e.g. known allergy 4. active bleeding at any site, excluding physiological vaginal bleeding 5. patients with bleeding disorders 6. known severe hypertension (sbp \>200mm/hg and/or dbp \>120mm/hg) during the current pregnancy or postpartum

Keywords: postpartum prophylaxis lmwh
a study to assess efficacy and safety of karxt for the treatment of psychosis associated with alzheimer's disease (adept-2)

Conditions: Psychosis Associated With Alzheimer's Disease

Summary: this is a phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of karxt in male and female subjects who are aged 55 to 90 years and have mild to severe alzheimer's disease (ad) with moderate to severe psychosis related to ad. the primary objective of the study is to evaluate the efficacy of karxt compared with placebo in the treatment of subjects with psychosis associated with ad as measured by the neuropsychiatric inventory-clinician (npi-c): hallucinations and delusions (h+d) score.


Eligibility criteria:
key inclusion criteria: 1. is a male or female aged 55 to 90 years, inclusive, at screening. 2. can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed. 3. meets clinical criteria for possible ad or probable ad. 4. living at the same home or residential assisted-living facility for a minimum of 6 weeks before screening. 5. have an identified study partner who should have daily contact (approximately 10 hours a week or more). 6. history of psychotic symptoms (meeting international psychogeriatric association criteria) (cummings 2020) for at least 2 months prior to screening. 7. cgi-s scale with a score ≥ 4 at screening and baseline. 8. ad subjects are required to have npi-c: hallucinations and delusions (h+d) score of ≥ 6 and meet at least 1 of the following criteria at screening and baseline: 1. moderate to severe delusions, defined as npi-c: delusions domain score of ≥ 2 on 2 of the 8 items or 2. moderate to severe hallucinations, defined as npi-c: hallucinations domain score of ≥ 2 on 2 of the 7 items 9. mmse score of 8 to 22, inclusive, at screening. key exclusion criteria: 1. psychotic symptoms that are primarily attributable to a condition other than the ad causing the dementia. 2. history of major depressive episode with psychotic features during the 12 months prior to screening. 3. history of bipolar disorder, schizophrenia, or schizoaffective disorder. 4. significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular, or oncologic disease or any other condition that, in the opinion of the investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results. 5. history or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the investigator. 6. prior exposure to karxt. 7. history of hypersensitivity to karxt excipients or trospium chloride. 8. experienced any significant adverse events (aes) due to trospium. 9. participation in another clinical study in which the subject received an experimental or investigational drug within 3 months before screening or has participated in more than 2 clinical studies in the 12 months prior to screening.
post trial access program of tak-577 for von willebrand disease (vwd)

Conditions: Von Willebrand Disease (VWD)

Summary: the post-trial access program allows eligible participants to gain access to unlicensed treatment on compassionate grounds. recombinant von willebrand factor (rvwf) also known as tak-577, is a medicine to help treat von willebrand disease (vwd). this post-trial access program enables continued access to children and adults who are benefitting from treatment on study shp677-304 (nct03879135) study.

this is a post-trial access program in which the drug being given is called tak-577. this study will provide access to tak-577 before marketing authorization for eligible participants with severe vwd who are benefitting from treatment on study shp677-304 and cannot adequately be treated via the current standard of care and cannot enter a clinical trial. all participants will receive tak-577 as a sequential intravenous infusion based on their weight. this is a multi-center, international program. participants will continue treatment until a benefit is no longer derived from the treatment (or treatment is no longer tolerable), the sponsor decision to end the program, the participant chooses to discontinue the treatment, or tak-577 becomes commercially available for children.

Eligibility criteria:
inclusion criteria: 1. participant has completed the treatment period of the shp677-304 study (at least 12 months on study treatment). 2. participant had good clinical response to rvwf treatment. 3. participant does not have access to any comparable or satisfactory alternative replacement therapy available at country level. 4. participant will be/has been negatively impacted by discontinuation of rvwf. 5. participant and/or a parent(s)/legal guardian is informed of the nature of the post-trial access program and can provide written informed consent for themselves or the child to participate (with assent from a child when appropriate) before treatment). exclusion criteria: 1. participants with known hypersensitivity/intolerance to the study drug will not be eligible for this study

Keywords: drug therapy
effect of fee on attendance in cervical cancer screening

Conditions: Cervical Dysplasia

Summary: several reasons can explain non-attendance in cervical cancer screening. in low resource settings the attendance is even lower. the effect of fee as contributing reason of non attendance has not been studied before why the investigators decided to study this in a low resource setting as a randomised trial.

non-attendance in the cervical cancer screening programme is the most important factors why swedish women contract the disease. low attendance rate is observed in districts with low socioeconomic resources. several reasons can explain this, including the existence of a fee. a low attendance rate in low resource districts is also noticed in gothenburg, sweden. after multiple interventions the coverage has slightly increased. none of the interventions included the aspect of the fee. the investigators decided to study the effect of fee abolishment in a randomized control trial emanating from the regular cervical cancer-screening program. method: randomized control trial (rct). women in low resource areas of gothenburg, due for screening, january-july 2013, were randomised to receive an offer of a free test or receiving the regular invitation stating the regular fee of 100 swedish kronor (sek) (≈11 €). power calculation has shown 80 % power to detect an increase in participation of 20% at 1972 participants.

Eligibility criteria:
inclusion criteria: * all women in the designated geographical area, consecutively enrolled in planned screening according to standard routine. i.e women are invited if they are between 23 and 60 years of age and don't have a pap smear registered the last three or five years according to age. exclusion criteria: * none

Keywords: attendance screening without fee
access to resources for patients with pten hamartoma tumor syndrome

Conditions: PTEN Gene Mutation

Summary: the purpose of this study is to gain a better understanding of access to clinical and research resources for families of children affected with a phosphatase and tensin homology (pten) mutation. ultimately, the researchers hope to be able to use this information to develop a standard of care for affected individuals and their family members. family members/legal guardians of an individual with a pten mutation enrolled in the rare diseases clinical research network (rdcrn) contact registry will be invited via email to participate in this study.

the purpose of this study is to investigate access to clinical care and clinical research for patients with pten hamartoma tumor syndrome. this research will entail an anonymous online survey sent to families/caretakers of affected children. the survey will inquire: (1) basic clinical information about the child, such as diagnoses (both genetic and neurodevelopmental), level of functioning (estimated iq) (2) clinical specialists that the child sees or needs to see (3) how families learn about clinical trials/research relevant to their child (4) basic demographics about the parent/caretaker completing the survey. specifically, this survey will collect information pertaining to: * number of affected children in household * pten mutation type of affected children * age and gender of affected children * age, neurodevelopmental disorders, medical problems, iq, and access to clinical care (specialists currently being seen, specialists not able to see and why) of most affected child * research methods and mediums for disorder-specific treatment options for affected children * reasons behind not participating in clinical research options * facts (gender, age, if pten mutation carrier, work status, relationship to affected children, days per week of caregiving responsibilities, education level) about participant completing survey. in total, the survey should take no more than 15 minutes to complete.

Eligibility criteria:
inclusion criteria: 1. family members, specifically a parent, legal guardian, or relative, of a child who meets the following: * age 3 to 17 years old at the time of survey completion * reported diagnosis of a pten mutation 2. enrollment in the rdcrn contact registry exclusion criteria: 1. inability to provide informed consent and complete survey 2. inability to read and understand english

Keywords: pten phosphatase and tensin homology mutation
s-amlodipine in essential hypertension and assessment of blood pressure targets achievement

Conditions: Essential Hypertension

Summary: evaluate the ratio(%) of patients whose blood pressure measured at 6 months from the baseline was confirmed to be within the target blood pressure range according to the 2022 hypertension treatment guidelines for essential hypertension patients who received the study drug.

primary purpose: evaluate the ratio(%) of patients whose blood pressure measured at 6 months from the baseline was confirmed to be within the target blood pressure range according to the 2022 hypertension treatment guidelines for essential hypertension patients who received the study drug. secondary purpose: 1. evaluate the efficacy by comparing the change in blood pressure for each drug pattern (monotherapy or combination therapy) at 6 months after administration of the drug to be studied in patients with essential hypertension. 2. evaluate the safety by checking the incidence (%) of adverse events after administration of the drug to be studied in patients with essential hypertension. 3. evaluate the safety by checking the peripheral edema incidence rate (%) after administration of the drug to be studied in patients with essential hypertension. 4. evaluate the safety by checking the headache incidence rate (%) after administration of the drug to be studied in patients with essential hypertension.

Eligibility criteria:
inclusion criteria: 1. adults over 19 years of age 2. a person who was diagnosed with essential hypertension at the time of participation in the study or was previously diagnosed with essential hypertension and is taking antihypertensive drugs for treatment (essential hypertension: systolic blood pressure greater than 140mmhg or diastolic blood pressure greater than 90mmhg) 3. a person whose prescription for the study drug under study was confirmed at the time of participation in the study 4. a person who voluntarily decided to participate in this observational study and gave written consent to the consent form exclusion criteria: 1. patients who are contraindicated in administration of study drug according to the permission * patients with a history of hypersensitivity to the study drug or its components or other dihydropyridine-based drugs * women who are pregnant or may be pregnant, and women who are lactating * patients with shock (including cardiogenic shock), severe aortic valve stenosis, unstable angina, within 1 month after myocardial infarction, severe hypotension, severe liver dysfunction 2. patients who are inappropriate to participate in the study in the judgement of the investigator
nasal septal flap for donor site reconstruction

Conditions: Nasal Septum Perforation

Summary: the purpose of this study is to demonstrate the utility of porcine small intestinal submucosa (sis) as a graft material that may aid in the natural healing process of freshly exposed bone and cartilage in the nasal cavity.

patients who undergo endoscopic endonasal skull base surgery, and may require nasoseptal flap placement as part of skull base reconstruction, will be informed, consented and enrolled for participation. if the intraoperative decision is ultimately made for harvest and placement of full-length nasoseptal flap by each individual surgeon, patients will then be consecutively, sequentially randomized to use of either: * thin doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone (20 randomly assigned patients) * 2x3 cm biodesign™ sis perforated mesentery graft surface placement plus overlying doyle silastic sheet placement over the resulting exposed septum cartilage/bone. (20 randomly assigned patients) when used, biodesign graft will be soaked in sterile saline out of the packaging, and placed as an intact single sheet over the exposed bone nasal septum bone/cartilage (without trimming). for uniformity and ease of future analysis, the bottom edge of the graft will be placed parallel to, and proximal to, the nasal floor cut edge remnant mucosal surface as possible. except for a thin doyle silastic sheet to cover the graft site, no additional reinforcement (suture/tissue glue) will be placed for those patients in the biodesign graft arm. time points and study parameters: * all enrolled patients will have doyle silastic sheeting removed only at 2 weeks post-op. * all patients will receive 250cc normal saline topical nasal rinses starting at 14 days until 120 days post-op. * no topical irrigation additives (budesonide/mupirocin) will be administered over 12 weeks. all patients will be assessed at 2 weeks, 6 weeks and 12 weeks following randomization and entry into this study.

Eligibility criteria:
inclusion criteria: * elective transnasal endoscopic skull base surgery where closure with a large nasoseptal flap (nsf) is anticipated (exposure of \>75% of the ipsilateral nasal septum bone/cartilage) * patients without nutritional compromise or otherwise debilitated * patients who are able to consent for themselves exclusion criteria: * bilateral nasoseptal flap (nsf) placement in the same operative setting * patients without significant bone/cartilage exposure to incorporate an intact 2x3 cm graft * patients requiring 24 hour supplemental oxygen via nasal cannula * patients who cannot consent for themselves

Keywords: nasoseptal flap tissue repair wound healing remucosalization upper airway granulation tissue tissue graft