Kornimate/medical-research-clean huggingface dataset:
assessing the utility of peak inspiratory flow as a predictor for copd exacerbations

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this is an international, mulitcentre, observational, prospective study into peak inspiratory flow in copd patients that aims to: a) determine the prevalence of suboptimal peak inspiratory flow (pif) and inadequate inhaler choice and assess the baseline characteristics of these groups. b) assess the clinical role of pif and inhaler choice in predicting copd exacerbations and symptom burden. c) assess the variability and correlation of pif with other lung function measurements and cat score in stable copd. it is a 12 month study comprising one baseline assessment and 2 follow-up visits at 6 and 12 months.


Eligibility criteria:
inclusion criteria: 1. spirometry-defined copd (i.e. post-bronchodilator fev1/fvc\<0.7) 2. age ≥40 years 3. smokers or ex-smokers of at least 10 pack-years 4. clinically stable copd (no exacerbations in the last 4 weeks) 5. capable of performing serial lung function tests 6. prescribed inhaled medication for at least 6 months exclusion criteria: 1. occurrence of an copd exacerbation during the previous 4 weeks 2. have any concomitant chronic respiratory condition other than asthma or bronchiectasis (e.g. cystic fibrosis, lung fibrosis, tuberculosis) 3. are unable to understand the instructions of the study or to fill the questionnaires 4. are unwilling to sign the informed consent 5. are participating in a clinical trial
gait evaluation of experienced below knee amputees

Conditions: Amputations, Traumatic

Summary: post traumatic amputees with an experience of over 3 months of prosthesis use at home, without any known difficulty using the prosthesis and without stump pathology, using no assistive devices, will be examined in a 3 d computerized gait laboratory. kinematic and kinetic parameters of gait will be obtained.


Eligibility criteria:
inclusion criteria: * post traumatic trans tibial amputees * no stump pathology * no assistive devices * no technical difficulty exclusion criteria: * vascular or dm background * stump pathology * gait difficulties * assistive device

Keywords: amputation trans tibial prosthesis motion analysis
efficacy and safety study of soluble beta-1,3/1,6-glucan in thermal burns

Conditions: Burns

Summary: the purpose of this study is to determine whether soluble beta-1,3/1,6-glucan is an effective and safe treatment of thermal burns and non-injured skin where skin grafts are harvested. hypothesis: soluble beta-1,3/1,6-glucan will through its immunomodulating activities improve wound healing of thermal burns and non-injured skin where skin grafts are harvested.

in severe cases, burn patients commonly exhibit a clinical picture of systemic inflammation with a variety of manifestations ranging from the presence of tachycardia, tachypnea, fever and leukocytosis, and may progress to refractory hypotension. shock and multiple organ system dysfunction may subsequently occur. sepsis, caused by infection or bacteremia, is also a common occurrence and a major complication in burn patients. after cooling the burned area, pain control is important. local burn wound care starts with cleansing the wound followed by application of topical agents to prevent infection. such agents may have adverse local or systemic effects and may impede on the wound healing process itself. the use of synthetic or biologic materials for wound covering is becoming increasingly popular, but most of the clinical information about efficacy of such products are anecdotal. a primary objective in burn care is to have all wounds healed within 1 month. with longer healing periods, there is an increasing likelihood of developing hypertropic scaring and alterations in pigmentation. the development of an effective wound healing agent would therefore be highly beneficial for the suffering patient in terms of decreased healing time and improved cosmetic results.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * written informed consent group a - patients with thermal burns * partial thickness burns (2nd degree) requiring non-surgical primary treatment * primarily 5-15% tbsa burns, but burn patients with injury size from 1 to 40% tbsa may be included or group b - patients with thermal burns * non-grafted partial thickness burns (2nd degree) in patients requiring autotransplantation in the early phase * primarily 5-15% tbsa burns, but burn patients with injury size from 1 to 40% tbsa may be included or group c - patients with thermal burns * donor site(s) on the ventral side of the body and limbs in deep partial thickness burns (2nd degree) and/or full thickness burns patients requiring autotransplantation during the first 1-3 weeks after injury * primarily 5-15% tbsa burns, but burn patients with injury size from 1 to 40% tbsa may be included exclusion criteria: * inhalation injury to airways and lungs * chemical or high voltage electrical burn * pregnancy, lactation * clinical signs or symptoms of acute infection * any prescription or non-prescription topical medication administered within one week prior to study start * hematological and clinical/chemical parameteres judged as unacceptable by the investigator * donor sites with re-harvesting * previous treatment with soluble beta-1,3/1,6-glucan * participation in other clinical studies in the last 4 weeks
role of indocyanine green (icg) for detection of sentinel nodes in breast cancer

Conditions: Breast Cancer

Summary: this is a single-center prospective study evaluating the diagnostic performance and safety of infracyanine in women with early breast cancer whose the research of sentinel node(s) combines isotopes and infracyanine.

visits: screening: complete physical and gynecological examination by surgical oncologist informed and signed consent form. the intervention will be planned within one month. intervention: in the beginning of the intervention, a periareolar injection of the infracyanine will be carried out (infracyanine®, 2ml to 2.5mg/ml whether 3.2nm). the search or sentinel node will be made using a infrared camera for transcutaneous visualization secondly, data lymphoscintigraphy may be communicated to the surgeon. the nodes are identified as sn fluorescent nodes and / or radioactive nodes. * all radioactive nodes and / or fluorescent will be deleted * reports of anatomy fluorescent sn and / or hot next visit: the patient will be reviewed in consultation in the months following the itervention for a clinical examination, the collection of adverse events.

Eligibility criteria:
inclusion criteria: 1. female age \> 18 years 2. invasive breast cancer ≤ 5 cm, unifocal bifocal or multifocal 3. diagnosis confirmed by biopsy 4. breast cancer extended in situ 5. first surgical treatment exclusion criteria: 1. neoadjuvant chemotherapy or hormone therapy. 2. multicentric tumor 3. pregnant patient 4. ongoing participation in another clinical trial with an investigational drug
the effect of workplace interventions on the treatment of low-back pain

Conditions: Back Pain

Summary: the study evaluates the effect of workplace interventions on work ability promotion among workers with back problems. the half of participant will receive information, advice and guidance for back problems in addition to participatory workplace actions organized by occupational health physiotherapist. the other half will receive only information, advice and guidance without workplace intervention.

musculoskeletal symptoms, especially back pain, account for the majority of days lost. in order to enhance the health and working careers of people with msd, it is important that work can be arranged in such a way that they can remain in work life despite msd.in the field of work ability promotion, various stakeholders; the worker, employer, professionals in occupational health services (ohs) interact to optimize actions and practices to prevent absences from work and promote remaining at work. this study aims to investigate participatory working practices and modles of co-operation among ohs and workplaces.

Eligibility criteria:
inclusion criteria: * back pain for at least two weeks or frequently occuring periods within the past 12 months exclusion criteria: * back problems with forcoming surcical operation

Keywords: musculoskelelal disorder occupational health service
effects of pelvic tilt exercises along with hip and knee focused exercises on patients with patellofemoral pain syndrome

Conditions: Patellofemoral Pain Syndrome

Summary: this study is designed as a randomized controlled trial to be conducted at the crc department of chaudhary muhammad akram teaching and research hospital, lahore.

a total of 48 participants will be recruited accounting for a 10% dropout rate (42+6=48) and equally divided into two groups 24 participants in each group: group a(intervention) and group b(control). participants will be selected based on inclusion criteria which includes individuals aged 35-55 years with a clinical diagnosis of patellofemoral pain syndrome (positive patellar compression test) symptoms persisting for at least 6 weeks to 6 months and moderate-to-severe knee pain (nprs ≥ 4). they must also be willing to comply with study protocols. exclusion criteria include recent knee surgery, other knee conditions (e.g., ligament injuries or severe osteoarthritis), and neurological disorders affecting movement or cognition.

Eligibility criteria:
inclusion criteria: * participants must have a clinical diagnosis of patellofemoral pain syndrome. * participants should be aged between 35 and 55 years, as this is the typical age group affected by pfps and will help standardize the sample. * individuals with a bmi ranging from 18 to 25 kg/m2. * participants should have had symptoms of pfps for at least 6 weeks to 6 months, ensuring the condition is subacute and chronic. * knee pain severity: patients must report moderate to severe knee pain (e.g., pain score ≥ 4 on a 0-10 pain scale) to assess the effectiveness of rehabilitation interventions. * participants must be willing to engage in the prescribed exercise program and comply with study protocols including follow-up assessments. exclusion criteria: * individuals who have undergone knee surgery within the last 6 months, as post-surgical rehabilitation could interfere with the study outcomes and confound results. patients with other knee conditions, such as ligament injuries (e.g., acl or mcl tears), meniscal tears or osteoarthritis, which could significantly affect rehabilitation or complicate the assessment of pfps. * individuals with severe knee osteoarthritis (e.g., kellgren-lawrence grade 3 or 4) as it may impact the treatment response and differ from the typical pfps rehabilitation approach. * individuals with neurological conditions (e.g., stroke, multiple sclerosis or peripheral neuropathy) that affect movement, balance or cognition making participation in rehabilitation exercises unsafe or difficult.
transrectal ultrasound robot-assisted prostate biopsy

Conditions: Prostate Cancer

Summary: prostate cancer (pca) is the most common non-dermatologic malignancy in u.s. men. transrectal ultrasound (trus)-guided prostate biopsy is a commonly used diagnostic procedure for men with an elevated serum prostate-specific antigen (psa) level and/or abnormal digital rectal examination (dre). it is estimated that more than 1 million trus-guided prostate biopsies are performed annually in the u.s. alone. however, a freehand trus-guided systematic biopsy (sb) procedure has significant limitations. first, freehand biopsy cores are often spatially clustered, rather than uniformly distributed, and do not accurately follow the recommended, sextant template. second, a freehand trus-guided biopsy does not allow precise mapping of the biopsy cores within the prostate. targeted biopsy (tb) using special devices emerged to help the physicians guide the biopsy using multiparametric mri (mpmri). tb cores yield a higher cancer detection rate of clinically significance pca than sb cores, but tb cores also miss a large number of clinically significant pca that are detected by sb. accordingly, tb is commonly performed concurrently with sb (tb+sb procedure).

this study attempts to improve trus-guided prostate biopsy by utilizing assistance from a novel robotic trus manipulator (trus-robot) developed by our team. the hypothesis of the study is that clinically significant prostate cancer detection rate from the sb cores (at sb or tb+sb) can be improved above that of current devices. the objective of the study is to gain early evidence on the effectiveness of prostate biopsy assisted by the trus-robot vs. a current tb device in a randomized clinical trial.

Eligibility criteria:
inclusion criteria: * scheduled for an initial diagnostic biopsy * elevated serum psa (prostate specific antigen\> 4 ng/ml) and/or abnormal digital rectal exam exclusion criteria: * clinical diagnosis of prostate cancer * prior prostate biopsy * anal stenosis that prevents trus probe insertion * inadequate bowel prep * unwilling or unable to sign the informed consent

Keywords: prostate cancer detection prostate biopsy prostate cancer transrectal ultrasound
the low voltage guided ablation trial of persistent atrial fibrillation

Conditions: Persistent Atrial Fibrillation

Summary: this study evaluates if the exclusion of left atrial low voltage areas / scars by ablation lines in addition to pulmonary vein isolation may improve the outcome in patients with persistent atrial fibrillation in comparison to stand alone pulmonary vein isolation.

this is a prospective, randomized multi center study comparing two catheter ablation strategies (pulmonary vein isolation (pvi) versus pvi plus low voltage areas (lva) guided for ablation in patients with symptomatic persistent and long standing persistent atrial fibrillation (af) who were unresponsive to at least one class i or iii antiarrhythmic agents, or it is the patient´s decision to receive ablation as first line therapy. patients with documented persistent af who are eligible for participation in the study, and gave a written informed consent, will be randomized between two groups prior to the procedure: pvi and pvi+lvas guided radiofrequency catheter ablation. all the patients will receive a high density voltage map in sinus rhythm (sr). all the patients will receive circumferential pvi. if lvas are present, patients randomized to the pvi+lva group will get additional linear ablation lines to exclude these areas from normal voltage atrial myocardium. the patients will be followed for 12 months.

Eligibility criteria:
inclusion criteria: * symptomatic patients with persistent af documented by 12 lead ecgs (persistent af is defined as an af episode which lasts longer than 7 days, persistent af which lasted longer than 12 months will be defined as long standing persistent af.) * age 18 - 80 years, both genders * patient is willing to participate in the study (signed written informed consent) * patient is willing and available to perform all follow ups. exclusion criteria: * atrial fibrillation due to reversible causes * any contraindication for af ablation * contraindications to anticoagulation * cva/tia in the past 6 months * previous left atrial catheter ablation
antibiotics in infancy--risk factor for childhood asthma

Conditions: Asthma; Lung Diseases

Summary: to examine possible relationships between antibiotic use, as determined by prescriptions filled, and asthma in children ages 6 to 7.

background: morbidity and mortality from childhood asthma have been increasing in all developed countries over the past three decades, including in the united states. numerous theories have been advanced to explain this asthma epidemic, but no single theory has held up to careful scrutiny. recent international studies have suggested a relatively strong causal relationship between increased risk of childhood asthma and exposure to antibiotics during childhood, especially during the first year of life. the increased asthma risk was seen whether antibiotics were used to treat respiratory or non-respiratory infections. while these previous studies are suggestive, there are significant methodologic concerns about each study. a major concern with most of the studies is their reliance on retrospective recall of antibiotic exposure data from parents years after the exposure. the study relied on prospective data from the childhood asthma study. design narrative: data were used from the prospective, nih-funded study of the relationship between early environmental exposures and the development of asthma in a birth cohort of children followed to an average 6.7 years of age. at 6.7 years, 482 (58%) of the original 833 children were clinically examined as part of this childhood asthma study (cas). in addition to clinical histories, the 6- to 7- year clinical examination included skin tests, ige antibody tests, pulmonary function tests and methacholine challenge. at entry all of the cas children were within the health alliance plan (hap) hmo. the study was based on combining the cas data set with pharmacy data extracted from the hap data archives. this allowed an examination of possible relationships between antibiotic use, as determined by prescriptions filled, and asthma at 6 to 7 years of age. while not strictly a prospective study, these methods avoided many of the potential sources of bias found in previous studies. the study was also able to evaluate any relationships between antibiotic exposure and asthma for confounding by other risk factors such as bedroom allergen levels, pet ownership, cigarette smoke exposure, and parental history of asthma or allergy.

Eligibility criteria:
no eligibility criteria
a study of the correlation between pharmacokinetic and pharmacodynamic parameters of cellcept (mycophenolate mofetil).

Conditions: Kidney Transplantation

Summary: this study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of cellcept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. all patients will receive oral cellcept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters will be measured at weeks 2, 4, 12 and 24. the anticipated time on study treatment is 24 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, 18 to 65 years of age * patients undergoing primary kidney transplantation exclusion criteria: * recipients of multiple organ transplants * prior therapy with cellcept * presence or history of malignancies, except for successfully treated basal or squamous cell carcinoma of the skin * active peptic ulcer or active serious digestive system disease that may affect the absorption of cellcept
osteoarthritis topical treatment

Conditions: Osteoarthritis

Summary: this is a phase 2a clinical trial performed to evaluate the efficacy of a topical treatment of ibuprofen compared to the use of a placebo topical treatment. a multi-center, double-blinded, randomized placebo controlled study. study length: 14 days dosing twice daily (b.i.d.)


Eligibility criteria:
main inclusion criteria: * male or female patients aged at least 40 years. * primary osteoarthritis in a single knee joint, grade ii/iii based on the kellgren and lawrence classification system. * radiographic evidence consistent with osteoarthritis carried out within 6 months before screening. * pain is currently not adequately controlled with a simple analgesic or an nsaid or would necessitate treatment, but is not yet treated. main exclusion criteria: * concomitant presence of another type of continuous pain that is more severe in intensity in comparison with the osteoarthritis target joint pain * osteoarthritis causing significant pain in any joint other than the identified knee, or contralateral knee (≥ 20 mm pain) as confirmed by a separate vas at visit 1 for any other painful joint concerned. * female patients who are pregnant or breast-feeding.

Keywords: osteoarthritis knee pain
endostyle: artificial intelligence image transformation tool for colonoscopy

Conditions: Colon Cancer; Colon Rectal Cancer

Summary: the study addresses the limitations of current ai systems in gastrointestinal endoscopy, which are tipically trained with data from a single type of endoscopy processor and have limited expert-annotated images. the investigators aim to develop and validate endostyle, an ai system that can generate images in the style of various processors from a single reference image. endostyle will be tested by showing endoscopists colonoscopy sequences with different image types to determine if they can distinguish ai-transformed images. success would enhance ai training for diverse clinical setups.

the use of artificial intelligence (ai) in gastrointestinal endoscopy has become widespread. however, these systems are often only trained with data from a single type of endoscopy processor, which limits their applicability. in addition, the availability of images annotated by experts is limited, which affects data variability and thus the performance of ai systems. the aim of this study is to develop a new artificial intelligence (ai) based system (endostyle) and validate its authenticity by means of a survey among physicians, which is able to generate multiple images in the style of different processor types (including olympus, pentax and storz) from a single endoscopy reference image. the investigators hypothesis is that the ai system is able to successfully change the image style of video processors, with the differences being imperceptible to the endoscopist's eye. the methodology consists of showing to multiple endoscopists 28 colonoscopy sequences of 10 seconds duration each. in each one of them 3 images will be shown that can be all the possible combinations of images belonging to positive control, negative control, and endostyle (intervention group). by performing a statistical comparison of the percentages of selected images for each group the investigators will be able to establish whether the participants are able to distinguish the images transformed by the ai. if the results corroborate our hypothesis, our system could generate images that would allow a more customized training of ai systems for each clinical setup.

Eligibility criteria:
inclusion criteria: * physicians with experience in colonoscopy.

Keywords: colonoscopy artificial intelligence