Kornimate/medical-research-clean huggingface dataset:
cornea ectasia excimer laser treatment

Conditions: Corneal Ectasia

Summary: to evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia with transepithelial topographic guided laser simultaneous central corneal remodeling (ccr) and cross-linking (cxl).

background to evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia performed with transepithelial topographic guided laser simultaneous central corneal remodeling (ccr) and cross-linking (cxl). methods in this retrospective study 8 eyes of 8 patients (mean age 31.50±14.73 years) affected by cornea ectasia underwent simultaneous ccr and cxl. preoperative and 6 month postoperative uncorrected distance visual acuity (udvc) and distance corrected visual acuity (dcva) were measured using the efficacy and safety index. objective and subjective quality of vision were evaluated preoperatively and 6 months postoperatively using corneal morphological irregularity index (cmi), national eye institute visual function nei-vfq25 and nei-vfq39 questionnaires.

Eligibility criteria:
inclusion criteria: - keratoconus with moderate severity (amsler-krumeich stage i-ii) exclusion criteria: * concomitant ocular disease * concomitant systemic disease * corneal opacities
prevalence of asymptomatic rupture in silimed breast implants

Conditions: Breast Implant Rupture

Summary: a prospective clinical research is to assess the prevalence of implant rupture and presence of extracapsular gel in an un-referred population of women who have been implanted with the silimed gel-filled mammary implants with or without any local or systemic systemic symptoms.


Eligibility criteria:
inclusion criteria: * female * subject implanted with the original silimed gel-filled implant. exclusion criteria: * mr imaging is not possible because of the following: * metal implant * battery activated stimulator * pregnancy * tattoos * body weight \>300 pounds * history of metal fragments in the eye * any other contraindication to mr exam.
effect of montelukast on remodelling markers in asthmatic children

Conditions: Asthma

Summary: airway smooth muscle cell layer thickening and sub epithelial fibrosis, key allergen-induced airway remodelling features not modulated by corticosteroids, are reversible by cyslt1 receptor blockade therapy in animals. no data are available, at the present, about the potential effect of lts receptor antagonists on airway remodelling in asthmatic children. in the present study, the investigators aim to assess whether the addition of montelukast to ics in mild asthmatic children to inhibit the release of mmp-9, timp-1, mmp-12, mmp-9/timp1 ratio, procollagen type i c-terminal peptide (picp) and tgf-beta in the airway fluid collected by induced sputum in asthmatic children. 30-40 atopic children with mild persistent asthma. children with asthma will be recruited and evaluated with a real life open label trial: they will be randomised into two groups at first visit (t1): 1) group a: in these patients montelukast tablets 5 mg and as needed beta agonist will be administered; 2) group b: in these patients beta agonist therapy only. all children will be evaluated after 8 weeks (t2). they will be tested for lung function, feno, metalloproteinase (mmp)-9, mmp-12, tissue inhibitor metalloproteinase-1 (timp-1), procollagen type i c-terminal peptide (picp) and tgf-beta1 levels in sputum.


Eligibility criteria:
inclusion criteria: * diagnostic criteria: the classification of asthma will be based on clinical history and examination and pulmonary function parameters, according to international guidelines. * stage and/or severity of condition: atopic children with mild intermittent asthma will be enrolled. atopy will be evaluated by skin-prick test to common allergens in the area. * confirmatory physical and laboratory findings: * age: ranging in age 6 to 14 years. * evidence of susceptibility to the disease under study * patients have not used ics during 3-month period prior to study entry exclusion criteria: * patients will be excluded if they had used oral steroids in the last month. * patients will be excluded if they had acute or chronic lung diseases other than asthma, upper or lower airway infection in the previous 3 weeks or during the trial, acute asthma exacerbation, or had used oral steroids in the last month. * patients will be excluded if they had acute or chronic lung diseases other than asthma, upper or lower airway infections in the previous 3 weeks or during the trial, acute asthma exacerbation, or had used oral steroids in the last month.

Keywords: asthma children remodelling metalloproteinases montelukast
a study of multiple doses of hm15211(efocipegtrutide) in obese subjects with nafld

Conditions: NAFLD

Summary: this study is a phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of hm15211 in obese subjects with nafld

this study will be single-blind and conducted in up to 6 cohorts comprising a total of up to 72 obese subjects with nafld. each cohort will enroll subjects to ensure that at least 12 subjects per cohort will complete the study. subjects will be randomized to investigational product (ip) or placebo in a 3:1 ratio via an interactive web response system (iwrs). per cohort (n=12 subjects), 9 subjects will be randomized to ip and 3 subjects to placebo. cohorts may partially overlap after at least 9 subjects have completed 2-4 weeks of treatment (2 weeks of treatment is reached at visit week 3) and a dose escalation decision has been made. study drug will be administered weekly over a period of 12 weeks.

Eligibility criteria:
inclusion criteria: * body mass index ≥ 30 kg/m2 * waist circumference ≤ 57 inches * fasting plasma glucose \< 7 mmol/l (126 mg/dl) * hba1c \< 6.5% * controlled attenuation parameter ≥ 300 db/m by fibroscan * liver fat by mri-pdff ≥ 10%. exclusion criteria: * a history of or active chronic liver disease due to alcohol, auto-immune, hiv, hbv or active hcv-infection or nash disease * any history of clinically significant chronic liver disease including esophageal varices, ascites, encephalopathy or any hospitalization for treatment of chronic liver disease; or model for end stage liver disease (meld) ≥ 10 * previous surgical treatment for obesity * uncontrolled hypertension * any weight control treatment * history or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis * history of major depression, anxiety, suicidal behavior or attempts, or other psychiatric disorder requiring medical treatment * history or current diagnosis of heart disease * presence of clinically significant ecg findings * history of renal disease or abnormal kidney function tests * history of alcohol or illicit drug abuse * daily heavy use of cigarettes or any tobacco product
vellore typhoid vaccine impact trial

Conditions: Typhoid Fever

Summary: this cluster randomised trial will examine the impact of introducing typhibev, a typhoid conjugate vaccine licensed in india, on the incidence of typhoid fever in a high burden urban setting in south india.

typhibev®, a typhoid conjugate vaccine from biological e, has been licensed by the central drugs standard control organaisation in india based on immunogenicity and safety data. a similar typhoid conjugate vaccine has been demonstrated in large clinical trials to provide 80% vaccine efficacy in nepal and bangladesh. the typhibev® has not been similarly evaluated. the demonstration of the impact of a city-scale typhoid conjugate vaccine introduction on the burden of typhoid will aid policy decisions on the use of typhoid conjugate vaccines in the national immunisation program. after written informed consent, the investigators will establish stimulated passive surveillance in 72,000 individuals between 1 and 30 years of age within the vellore demographic surveillance system to determine the incidence of blood-culture confirmed typhoid fever. thirty-six thousand surveillance participants between 1 year and 30 years residing in the 30 clusters (areas) randomised to receive the vaccine will receive the vaccine at the beginning of the trial. those in other areas will receive the same at the end of two years. using a stimulated passive surveillance approach, those with acute febrile illness will be encouraged to visit study surveillance hospitals. participants will be evaluated for blood-culture confirmed typhoid fever if they are eligible. the incidence of typhoid among those living in areas assigned to vaccination compared to those whose residence is in areas not designated for vaccination will be used to calculate the impact of the vaccine on disease burden.

Eligibility criteria:
inclusion criteria: * consent * for adults, 18 years and over - they must be willing and competent to provide informed consent * for those aged under 18 years, the parent/guardian is willing and competent to provide informed consent, and if the participant is 11 to 18 years of age, informed assent will also be sought, * age: * between 1 and 30 years (i.e., up to 29 years 364 days) at time of recruitment into the surveillance * currently living within the study catchment area with no plans to leave the study area in the next 24 months exclusion criteria: * for fever surveillance o medical reasons that prevent the participant from complying with study requirements including follow up and testing during illness * for vaccination * has received a typhoid vaccine in the previous three years * is known to have an allergy to any vaccine component * nursing mothers, pregnancy or planning pregnancy around vaccination * receipt of any other vaccine in the past 30 days (temporary exclusion) * febrile illness in the 24 hours before vaccination (temporary exclusion)

Keywords: typhoid conjugate vaccine cluster randomised trial enteric fever
adaptive family treatment for adolescent anorexia nervosa

Conditions: Anorexia Nervosa

Summary: anorexia nervosa (an) has the highest mortality rate compared to any other psychiatric disorder. the most promising treatment for adolescents with an is family-based treatment (fbt). however, only 50% of patients receiving fbt fully remit at 12-month follow-up. consequently, providing an alternative therapy early in the treatment course for those not responding to fbt may enhance overall outcome. this study aims to develop a new treatment - intensive family-focused treatment (ift) - to improve outcomes in those adolescents, aged 12-18 years, who do not show an early response to fbt.


Eligibility criteria:
inclusion criteria: * meets dsm-iv criteria for anorexia nervosa * lives with at least one english-speaking parent who is willing to participate * medically stable * adequate transportation to clinic * proficient at speaking, reading, and writing english exclusion criteria: * previous fbt for an * medical condition that may affect eating or weight

Keywords: eating disorder anorexia nervosa eating disorder not otherwise specified maudsley family-based therapy fbt family therapy
benefit/risk evaluation of insuman implantable versus insuplant using medtronic minimed implantable pump system in patients with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: primary objective: to compare insuman implantable 400 iu/ml versus insuplant 400 iu/ml with respect to the pump refill accuracy during a 4 refill cycle period (i.e. the comparative phase); to assess efficacy measured by hemoglobin glycosylated (hba1c) change in insuman implantable 400 iu/ml group versus insuplant 400 iu/ml group after a 4 refill cycle period (i.e. the comparative phase). secondary objective: to assess efficacy, safety, refill accuracy evolution and device interventions during the open-label treatment period with insuman to evaluate daily insulin doses to assess anti-insulin antibodies (adas or aia) levels during all study phases

the study duration will be displayed in 2 parts as follow: comparative phase (only french patients): 160 +/- 20 days open label insuman implantable extension phase (french and european patients): from day 160 up to the grant of insuman implantable marketing authorization

Eligibility criteria:
inclusion criteria: 1. patients already treated with insuplant 400 iu/ml via a medtronic implantable system 2007 2. glycosylated hemoglobin ≤9.0% 3. patient showing a percentage of error at refill equal or below 20% 4. patient undergoing naoh rinse procedure of at least 10 minutes period with or without flush or patient being re-implanted with a new pump (first fill with insulin) 5. signed informed consent form prior to enrolment exclusion criteria: 1. pump life time \> 6 years 2. pump battery voltage \< 2.6 volts 3. pregnancy or childbearing potential without a medically approved form of birth control the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
efficacy of acceptance and commitment therapy for the management of quality of life in patients post myocardial infarction

Conditions: Psychological Distress; Type D Personality; Medication Adherence; Quality of Life

Summary: the present study aims to investigate the efficacy of acceptance and commitment therapy for the management of quality of life in patients post-myocardial infarction

the current quantitative study is carried out in two steps. a cross-sectional survey assesses quality of life and associated factors during the first step. a randomized controlled trial will be done during the second step where patients with myocardial infarction who are identified with type d personality characteristics, psychological distress, low level of medication adherence, low social support, low quality of life, low acceptance and psychological flexibility will be randomly assigned to two groups i.e. waitlist control group and intervention group. the acceptance and commitment therapy would be implemented on participants in the interventional group. as the control group is the waitlist control group; initially no intervention will be given to participants in the control group but the intervention will be given to the control group participants once the study is completed.

Eligibility criteria:
inclusion criteria: 1. first-time diagnosed, non-hospitalized patients with myocardial infarction (mi). 2. patients attending follow-up visits at the hospital. 3. patients experiencing distress. 4. patients exhibiting features of type d personality. 5. patients reporting low levels of: * quality of life (qol) * medication adherence * social support * acceptance * psychological flexibility 6. patients aged 18 years and above. 7. both genders. 8. patients who can understand urdu. 9. patients who can provide informed consent. exclusion criteria: 1. hospitalized patients with myocardial infarction (mi). 2. patients with myocardial infarction (mi) and other chronic co-morbid diseases, such as: * cancer * cognitive deficits * chronic psychological disorders 3. patients with silent myocardial infarction. 4. patients younger than 18 years.
177lu-dota-eb-tate in patients with advanced neuroendocrine tumors

Conditions: Neuroendocrine Tumors

Summary: this is an open-label, non-controlled, non-randomized study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluation safety and dosimetry of 177lu-dota-eb-tate in patients with advanced metastatic neuroendocrine tumors. a single dose of 0.50gbq-0.70gbq (13.5-18.9 mci) of 177lu-dota-eb-tate will be injected intravenously. and monitored at 2, 24, 72,120 and 168 hours post-injection with semiquantitative method based on quantitative single-photon emission computed tomography/computed tomography (spect/ct) performance.

neuroendocrine tumors (nets) are a heterogeneous group of neoplasms that can develop anywhere in the body and arise from neuroendocrine cells throughout the endocrine system. the most recent nccn guidelines for unresectable and metastatic net recommend somatostatin analogues as first-line treatment, but do not recommend a particular treatment sequence for the remaining therapies. radiolabeled somatostatin analogue therapy, also known as peptide receptor radionuclide therapy has become a well-accepted treatment for patients with well to moderately differentiated unresectable or metastatic nets and disease progression after first-line treatment. however, a major problem in the therapeutic use of 177lu-dotatate has been its short half-life and fast rate of clearance. this study was designed to investigate the safety, dosimetry and preliminary effects of a long-lasting radiolabeled somatostatin analogue 177lu-dota-eb-tate in patients with advanced metastatic neuroendocrine tumors.

Eligibility criteria:
inclusion criteria: * adults who had neuroendocrine tumors and had metastasized, that were with histologically confirmed, inoperable and had showed disease progression according to response evaluation criteria in solid tumors \[recist\]. tumors were with well-differentiated histologic features and a ki67 index of 0 to 20%. target tumors were selected from ct, mri, and 68ga-dota-tate pet/ct, with confirmed somatostatin receptor-expressing and at least one lesion has higher uptake than that of normal liver parenchyma on 68ga-dota-tate pet imaging within 1 weeks. exclusion criteria: * the exclusion criteria were a serum creatinine level of more than 150 μmol per liter, baseline measured gfr of less than 50 ml/min/1.73 m2, determined by 99mtc-dtpa renal function examination, a hemoglobin level of less than 8.0 g/dl, a white-cell count of less than 2.0× 109/l, a platelet count of less than 75 × 109/l, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia, and pregnancy or breastfeeding.
laparoscopic or abdominal radical hysterectomy for cervical cancer(stage ia1 with lvsi, ia2)

Conditions: Cervical Cancer

Summary: the purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (lrh) and abdominal radical hysterectomy (arh) in patient survival for cervical cancer (stage ia1 with lvsi, ia2)

the purpose of this study is to compare lrh (or robotic-assisted) and arh in patients with cervical cancer (stage ia1 with lvsi, ia2), by a multicenter stratified randomized controlled study, mainly including the following aspects: 1. to compare the differences in pfs and os between patients receiving lrh and arh. 2. to investigate whether pfs and os in lrh can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes). 3. to assess postoperative complications and quality of survival.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (ia1 with lymphovascular interstitial invasion, stage ia2). 2. age ≥ 21 years and ≤ 70 years. 3. surgery type b and c (refer to q-m surgical staging) 4. normal range of liver and kidney function and blood count (specific details below) hemoglobin \> 60g/l platelets \> 70\*109/l leukocytes \> 3\*109/l creatinine \< 50mg/dl transaminase abnormal indicators ≤ 3 maximum value of transaminases not exceeding 3 times the corresponding normal value. 5. no history of other malignancies. 6. non-pregnancy. 7. physical strength classification: karnofsky score ≥ 60; 8. subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up. 9. no psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, hiv infection, etc.) (note: maximum diameter measurement of cervical lesions is based on pet-ct, or ct, or mri) exclusion criteria: 1. those who are contraindicated for various surgeries and cannot undergo surgery. 2. patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer. 3. patients with recurrent cervical cancer 4. patients with ct, mri or pet-ct suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter \>2cm after further improvement of preoperative examination.

Keywords: cervical cancer abdominal radical hysterectomy laparoscopic radical hysterectomy
exercise training in chronic obstructive pulmonary disease (copd)

Conditions: COPD

Summary: exercise training is the key component of respiratory rehabilitation.the success of long-term program resides in the integration between exercise prescription and patients'compliance with home training. this can be difficult for patients, especially in terms of understanding the exercise intensity. this study is designed to evaluate different methods of exercise training at home, to help understanding and maintaining the walking intensity in copd patients. outcome: exercise performance, daily physical activity and respiratory function.


Eligibility criteria:
inclusion criteria: * copd patients. all patients are at stable state, free from an exacerbation from at least 3 months. exclusion criteria: * copd patients with a recent history of cardiovascular disease and other diseases that would interfere with exercise performance.

Keywords: copd home exercise training
retrospective observational study on infective complications and outcome of patients with all treated with ino

Conditions: Acute Lymphoblastic Leukemia; Infections; Bacterial Infections; Viral Infection; Fungal Infection; Acute Lymphoblastic Leukemia, Adult; Acute Lymphoblastic Leukemia, in Relapse

Summary: the goal of this observational study is to learn about infectious complications in patients affected by b-cell acute lymphoblastic leukemia treated with inotuzumab-ozogamicin (ino). the main question it aims to answer is: • incidence of infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin up to 60 days after the end of treatment

the present study is a multicenter, retrospective, observational clinical-epidemiological study on infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin (ino). the study collects data from about 20 hematologic centers of the gimema group treating b-cell acute lymphoblastic leukemia (all) patients with inotuzuumab-ozogamicin (ino) over the last 5 years (2018-2023), according to the authorized indications and not included in interventional clinical trials (randomized or not randomized).

Eligibility criteria:
inclusion criteria: * adult patients (\>18 years old) * patients with relapsed/refractory cd22 positive b-all treated with ino or with relapsed/refractory cd22 positive and ph-positive b-all treated with ino after failing at least one tki inhibitor * signed informed consent if applicable. exclusion criteria: • patients treated with ino in interventional clinical trials.