Kornimate/medical-research-clean huggingface dataset:
improving pulmonary function following radiation therapy

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to develop radiation plans that will help preserve lung function in healthy tissue surrounding the tumor. we believe that 4dct scans can be useful in designing radiation treatment plans that help us avoid healthy normal functioning lung tissue close to lung tumors. currently 4dct scans are used to help us determine exactly where the tumor is and how it moves when you breathe. in this study we will also use the 4dct scans to try to identify high functioning normal lung tissue.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of non-small cell lung cancer or lung metastasis from a solid tumor. one biopsy site is adequate for multiple sites of thoracic disease. * treatment includes localized radiation therapy with or without chemotherapy * karnofsky ≥ 60% * not pregnant per radiation oncology standard procedures * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * prior (within last 6 months) or future planned therapeutic surgery for the treatment of the existing lung cancer * prior thoracic radiotherapy * severe copd defined as disease requiring an inpatient stay for respiratory deterioration within the past 3 months * oxygen dependence of \> 2 l/min continuously throughout the day at baseline * known underlying collagen vascular disease or intrinsic lung disease that could complicate expected sequelae of radiation (idiopathic pulmonary fibrosis, wegener's granulomatosis) * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
a phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of medi8897 in healthy adults

Conditions: Respiratory Syncytial Virus Infections

Summary: the purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (rsv) monoclonal antibody compared to placebo when administered to healthy adult participants.

this was a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of medi8897 compared to placebo when administered to healthy adult participants. there were 136 participants randomized to receive medi8897 or placebo at one site. investigational product was delivered intravenously (iv) to 3 cohorts and intramuscularly (im) to 2 cohorts. 4 different dose levels of investigational product were evaluated across the 5 cohorts. participants were followed for approximately 1 year.

Eligibility criteria:
key inclusion criteria: * age 18 through 49 years and in good health by history, physical exam, and labs * weight greater than or equal to (\>=) 45 kilogram (kg) and less than or equal to (\<=) 110 kg at screening * written informed consent prior to performing any protocol related procedures, including screening evaluations * ability to complete the follow-up period of 360 days key exclusion criteria: * acute illness including fever \>= 99.5 fahrenheit (°f) on day of dosing * any drug therapy within 7 days prior to day 1 (except contraceptives) * receipt of any investigational drug therapy within 120 days prior to investigational product dosing through 360 days after investigational product dosing * previous receipt of a monoclonal antibody (mab) * pregnant or nursing mother * concurrent enrollment in another interventional study

Keywords: respiratory syncytial virus, rsv
endotoxin challenge study for healthy men and women

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the proposed study will examine the effect of pre-treatment with inhaled gsk256066 using a lung inflammation model induced by bronchoscopic instillation of bacterial endotoxin (lipopolysaccharide, lps) in healthy volunteers.data from this study will be used to support gsk256066 dose selection for future studies in copd patients.


Eligibility criteria:
inclusion criteria: * healthy males and females (contraception restrictions), * 18-50yrs, * bmi 19-31kg/m2, * non-smokers, * fev1 \>/= 80% predicted exclusion criteria: * abnormal troponin and/or ck mb, * participated in any gsk study involving the administration of coa for \>/= 21 days.

Keywords: lps challenge, healthy volunteers
use of glidesheath slender to reduce radial artery occlusion following 7 french transradial coronary intervention

Conditions: Radial Artery Occlusion; Coronary Artery Disease

Summary: the objective of this study is to determine the rate of early radial artery occlusion following 7-french(7-fr) transradial coronary intervention using a new terumo (tokyo, japan) glidesheath slender, in comparison with the currently used 7-fr radial sheath.

based on previously reported studies the rates of radial artery occlusion using a standard 7-fr sheath is around 12%, compared to the previous studies of the glidesheath slender (see reference in the citations), the rate of radial artery occlusion was reported less than 5%. to prove slender sheaths are superior to traditional ones, the sample size was estimated according to this, the class i error (α) is set as 0.05 on both sides, and the test efficiency (β) is set as 80%, then at least 248 patients are needed in each group. this study will be a prospective randomized, single-blinded (patient-blinded) study, comparing the rate of radial artery occlusion between the 7-fr glidesheath slender (terumo, japan) and the standard 7-fr radial sheath (cordis, usa) in patients undergoing complex transradial coronary intervention. the study will enroll patients who will undergo elective complex percutaneous coronary intervention (pci) via 7-fr transradial approach at fuwai hospital national center for cardiovascular diseases. a baseline clinical vascular \& ultrasound assessment will be performed prior to the procedure to document patency of the radial artery. patients will be randomized in 1:1 fashion to either receive the 7-fr terumo glidesheath slender versus the currently used 7-fr sheath. the standard angiogram/ pci will be performed as per usual practice. following the pci, clinical vascular assessment as well as an ultrasound will be performed prior to discharge.

Eligibility criteria:
inclusion criteria: * patients undergoing coronary pci via 7-fr transradial approach * informed consent * the patency of radial artery confirmed by ultrasound exclusion criteria: * the abnormal of radial artery confirmed by ultrasound * previous failed radial access. * known bleeding disorder or hypercoagulable condition * cardiogenic shock

Keywords: radial artery occlusion 7-fr radial sheath transradial coronary intervention
neuralnet cerebral palsy pilot study

Conditions: Cerebral Palsy

Summary: the neuralnet cerebral palsy pilot study is testing a genetic testing pathway in the nhs for children with cerebral palsy (cp). other studies suggest that almost one in three peoples' cp is caused by a change in their genes, but more studies are needed to confirm this. a genetic test called whole genome sequencing (wgs) will be used for children who have cp to look for rare changes in genes that cause the condition, and the results of the test will be given to children's doctors within 12 weeks. knowing that cp has a genetic cause could lead to changes being made to a child's care or treatment that could improve their condition. the study will test 66 children with cp from 3 hospitals, and also their biological parent(s), if they're available. following informed consent, the investigators will collect a blood sample from everyone taking part which will be sent for wgs. it is important to understand what families think and feel about the testing. the investigators will ask parents/guardians of the children taking part to fill in two questionnaires, one before and one after wgs. some parents/guardians will also be interviewed after getting the wgs result, to ask about their experience of the testing. the study will take up to 16 months per family. the results of this pilot study will tell the investigators if it is feasible for the nhs to use wgs to test children with cp. if so, a larger study testing more children with cp can then be carried out to help decide if this type of wgs-based testing should be made available through the nhs to children with cp whose clinical care might be changed by the result. the genetic findings from this study will also be made available to other researchers and doctors to do more research into cp that might help improve general understanding of the condition and its potential treatment.


Eligibility criteria:
inclusion criteria: children with cerebral palsy (cp): 1. has a clinical diagnosis of cp in the medical record 2. any gmfcs score (gmfcs 1-5) 3. does not have a known genetic diagnosis that explains the cp phenotype 4. has a parent/legal guardian available who can consent and is willing to complete study questionnaires 5. invited to participate by a clinician at a participating recruitment site biological parents of children with cp will also be included in the study if they are: 1. a biological parent of the child 2. aged 18 years or above 3. willing and able to give informed consent for participation in the study participant type exclusion criteria: children with cerebral palsy (cp): 1. children that have a pre-existing genetic diagnosis from whole genome sequencing or whole-exome sequencing 2. children not matching the inclusion criteria biological parents of children with cp will be excluded from the study if they do not meet the biological parent inclusion criteria i.e. they are not: 1. a biological parent of the child 2. aged 18 years or above 3. willing and able to give informed consent for participation in the study
periodontal and salivary evaluation of type 1 diabetes mellitus patients

Conditions: Diabetes Mellitus, Type 1; Periodontal Diseases

Summary: diabetes mellitus is a risk factor for periodontal disease increasing its prevalence, extension and severity. periodontal disease is considered the sixth complication of diabetes. there is a global epidemic of diabetes, including an increase of incidence of type 1 diabetes in younger patients. thus, the aim of this observational study was to evaluate the periodontal and salivary condition of a sample of patients with type 1 diabetes of a brazillian city.


Eligibility criteria:
inclusion criteria: * diagnose of type 1 diabetes mellitus * age between 18 and 35 years old * presenting on tooth per quadrant exclusion criteria: * diagnose of type 2 diabetes mellitus * edentulous patients * other systemic diseases

Keywords: saliva
an outcomes study to determine the reasons patients on biologic therapy discontinue treatment and fail to follow-up with their providers

Conditions: Psoriasis

Summary: patient interviews to evaluate the reason patients discontinue biologic therapy and/or fail to follow up with provider.

retrospective chart review and patient interviews to evaluate the reason patients discontinue biologic therapy and/or fail to follow up with provider. this research intends to improve the continuity of care by determining why patients stop therapy and what can be done to improve their experience with the provider, pharmaceutical companies and specialty pharmacies.

Eligibility criteria:
inclusion criteria: * male or female adults ≥ 18 years of age. * was receiving first or second biologic therapy * has not had a follow up with treating physician in ≥ 9 months exclusion criteria: * actively receiving biologic therapy * was not receiving first or second biologic therapy
short leg walking plaster cast versus walking foot cast for jones fracture

Conditions: Jones Syndrome; Metatarsal Bone Fractures

Summary: this study is an open-label, randomized controlled trial comparing the effectiveness of two plaster cast methods-short leg walking plaster cast and walking foot plaster cast-for treating jones fractures, a common fracture at the base of the fifth metatarsal in the foot. this trial will be conducted at lady reading hospital peshawar. the study will evaluate differences in fracture healing and functional outcomes between these two treatment approaches. findings from this trial may guide more evidence-based treatment protocols for jones fractures, potentially improving patient mobility and recovery without requiring surgical intervention.

jones fractures represent 26.3% of fractures at the base of the fifth metatarsal and are commonly treated conservatively through various weight-bearing casts. the lack of consensus on the optimal casting method for jones fractures necessitates further study, particularly given the absence of published guidelines. this trial, unique in its randomized and prospective approach within pakistan, aims to compare short leg walking plaster casts and walking foot plaster casts specifically for jones fractures. patients meeting the inclusion criteria will be randomly assigned to one of the two treatment groups, with the primary endpoints being fracture healing (union) and functional outcomes at six weeks, assessed via radiographs and the american orthopaedic foot and ankle score (aofas). this study seeks to produce robust evidence to inform treatment guidelines, allowing patients, especially in low- and middle-income settings, to continue daily activities with minimal disruption during recovery.

Eligibility criteria:
inclusion criteria: * both genders * 18 years and above * jones fractures that are un-displaced or minimally displaced (less than 2 mm) * fractures presented within 7 days of injury exclusion criteria: * significant foot swelling * open fractures * ipsilateral foot, ankle, or lower limb soft tissue pathology or fractures * pathological fractures

Keywords: jones fracture non-surgical management conservative treatment walking cast plaster cast treatment
patient characteristics, associated factors, and clinical outcomes of prescribing encorafenib and binimetenib versus dabrafenib and trametinib among braf v600 mutated metastatic melanoma patients

Conditions: BRAF v600 Mutated Metastatic Melanoma

Summary: this was a retrospective real-world evidence cohort study. the study was conducted using the noble (novartis braf+ melanoma patients observational) dataset, with a study period from 01 january 2011 to 31 may 2020. all included patients were ≥18 years of age and were required to have a diagnosis of unresectable stage iii or iv melanoma (icd-9 172.x \& icd-10 c43 or d03x), treatment with dabrafenib and trametinib (dab/tram) or encorafenib and binimetenib (enco/bini) on or after 01 june 2018, and evidence of a braf-positive result prior to or up to 30 days after therapy initiation. no quota of centers was established a priori. given the retrospective nature of this study, all patients who met the inclusion/exclusion criteria from the noble dataset were included.


Eligibility criteria:
inclusion criteria * diagnosis of melanoma (icd-9 172.x \& icd-10 c43 or d03x) * pathologic stage iii (unresectable) or iv at initial diagnosis on or after 01 january 2011 * 1l treatment with enco/bini or dab/tram on or after 01 june 2018 * evidence of a braf test * evidence of a braf-positive result prior to or up to 30 days after 1l therapy initiation * at least 18 years of age at the time of initiation of 1l treatment exclusion criteria * documented receipt of a clinical trial treatment for cancer at any time on or after september 2015 * diagnosis of a second primary cancer or secondary cancer following initiation of 1l metastatic melanoma (mm) treatment
the effect of cognitive group exercise combined with physical exercise in ms

Conditions: Multiple Sclerosis

Summary: the aim of this study is to investigate the effect of cognitive rehabilitation in group with physical exercise in patients with multiple sclerosis. we assume that cognitive therapy is an effective treatment for multiple sclerosis.

the aim of this study is to investigate the effect of cognitive rehabilitation in group with physical exercise in patients with multiple sclerosis.

Eligibility criteria:
inclusion criteria: * patients with an mini mental state test score less than 24 * patients with an extended disability status scale score less than 4 * patients trained for at least 5 years * patients who have not received steroid therapy in the last 1 month exclusion criteria: * patients who have not passed at least 3 months from the last multiple sclerosis attack * patients with hearing and vision problems that may interfere with communication * the patients who have other neurological and psychiatric disorder that will cause cognitive impairment * patients receiving medical treatment for spasticity, tremor, bladder disorder and fatigue
microtrans - a multicenter registry of fecal microbiota transplantation

Conditions: Clostridium Infections

Summary: the registry collects cases of patients received fecal microbiota transplantation (fmt) due to clostridium difficile associated diarrhea (cdad). the main objective of this study is to analyze the safety and effectiveness of fmt. furthermore, data analysis will be used to implement a standardization of fmt in german hospitals and improve patient outcome. therefore, a detailed description of completions of fmt are documented on our web-based survey platform www.clinicalsurveys.net.

concerning the documentation of patients received fecal microbiota transplantation (fmt) due to clostridium difficile associated diarrhea (cdad), physicians from all german hospitals performing a fmt are invited to provide prospective and retrospective information on these cases. documentation of patient is performed by using the web-based survey platform www.clinicalsurveys.net which was set up by researchers of the university hospital of cologne. this survey platform enables an optimal performance in epidemiological, observational, and interventional trials and is characterized by layered access security and frequent data backup. it has been used for numerous registry and cohort studies with approval of competent authorities and ethics boards. the following data items are retrospectively or prospectively documented into our database, depending on if a informed consent exists or not: * patient characteristics (age, gender, weight, height, underlying disease) * indication for fmt * administration of antibiotics, chemotherapy, and immunosuppression prior to fmt * bowel movement prior to fmt * screening prior to fmt * description concerning completion of fmt * basic informations of the donor * outcome * prospective long term follow up (10 days, four weeks, three months, six months, and 24 months) the following two differences of data documentation are observed: 1. retrospective data documentation: data of patients without an informed consent are documented strictly retrospectively after completion of the fmt. no pseudonymization of patient data is carried out so that no re-identification is possible. 2. prospective data documentation: data of patients with an informed consent prior to fmt are documented prospectively. a pseudonymization of patient data allows a post-fmt contact (by writing or phone) to patients with respect to the 10 days, four weeks, three months, six months,and 24 months follow-up.

Eligibility criteria:
inclusion criteria: * patients with clostridium difficile associated diarrhea exclusion criteria: * patients \< 18 years old

Keywords: fecal microbiota transplantation (fmt) clostridium difficile associated diarrhea (cdad)
inositol supplementation to treat pcos (insupp-pcos)

Conditions: Polycystic Ovary Syndrome; Anovulation; Hyperandrogenism; Insulin Resistance; Glucose Intolerance; Metabolic Complication

Summary: to determine if inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with polycystic ovarian syndrome(pcos).

this trial will test prospectively the effects of inositol supplementation in a dose ranging double blind randomized controlled trial, according to consort guidelines. this will be a four armed study of three doses of inositol vs. placebo over a three month period with the reduction in hyperandrogenism (based on serum testosterone levels) as the primary outcome and key secondary outcomes of the change in sex hormone binding globulin(shbg) and the related free androgen index, fasting insulin levels and area under the curve glucose levels from an oral glucose challenge test (ogtt). the hypothesis is that women with pcos who receive inositol supplementation will have a dose related reduction in hyperandrogenism. further, we propose that the primary mechanism of inositol will be a significant improvement in hyperandrogenism (both ovarian and adrenal) vs. placebo, as documented by a lower free androgen index \[decreased total testosterone and increased sex hormone blinding globulin (shbg)\], lower sebum measures and lower antral follicle counts of the ovary and anti-mullerian hormone, all of which will correlate with the decrease in hyperandrogenism.

Eligibility criteria:
inclusion criteria: * women with chronic anovulation or oligomenorrhea defined as spontaneous intermenstrual periods of greater than or equal to 45 days or a total of less than or equal to 8 menses per year. * women with hyperandrogenism defined as a total testosterone greater than 50 ng/dl or a free androgen index greater than 10. * women with polycystic ovaries on ultrasound defined as either 12 or more follicles measuring 2-9 mm in diameter or increased ovarian volume greater than 10 cm. exclusion criteria: * women with hyperprolactinemia defined as 2 prolactin levels at least one week apart greater than 30 ng/ml. * women with known 21-hydroxylase deficiency or other enzyme deficiency leading to the congenital adrenal hyperplasia. * women with elevated fsh levels greater than 10 miu/ml. * women with uncorrected thyroid disease as per asrm guidelines for nonpregnant subjects (tsh less than 0.45 miu/ml or greater than 4.5 miu/ml). * women with a suspected adrenal or ovarian tumor secreting androgens * women with cushing's syndrome * women on confounding medications which affect ovarian function including metformin, hormonal contraceptives or other medications for type 2 diabetes * women with medical conditions that are contraindications to otc inositol or previous allergic reactions to the supplement or to the placebo maltodextrin or inulin.

Keywords: polycystic ovary syndrome anovulation hyperandrogenism insulin resistance glucose intolerance metabolic complication