Kornimate/medical-research-clean huggingface dataset:
cara treatment pilot study for breast positioning

Conditions: Breast Cancer; Side Effect

Summary: cara is a novel carbon-fibre adjustable and re-usable accessory for supine breast positioning during radiation therapy. cara was developed at bc cancer. in this study, twenty patients will be planned and treated with cara positioning to establish safety and workflow measures of this novel device. the device is designed to remove the infra-mammary skin fold and lateral breast droop which can lead to unwanted dose to normal tissue.

this pilot study will investigate the safety and potential benefits of cara breast positioning by treating 20 patients using the device. patients will be planned with cara positioning and standard of care positioning. cara plans will be evaluated to ensure all treatment planning goals are met and patients will proceed to treatment with cara positioning. this pilot study will ensure that patients can be safely treated with the cara and provide us with valuable information from therapists, oncologists and patients about the performance of the current design. this will also inform the direction of design improvements and the production of educational materials for training practitioners in the use of the device. overall, this will prepare us for a randomized clinical trial of the cara positioning technique versus current standard of practice to assess whether reduced toxicity can be achieved using the cara technique.

Eligibility criteria:
inclusion criteria: patients diagnosed with completely excised stage i or ii invasive breast cancer, or ductal carcinoma in situ (dcis), who have undergone breast-conserving surgery and are scheduled to undergo adjuvant breast radiotherapy; any breast size with a skin fold of depth 1 cm or greater at the infra-mammary crease at the time of radiation treatment planning, or brassiere cup size equal to or larger than d; patients undergoing nodal radiotherapy are eligible if the above criteria are met; patients undergoing boost radiotherapy are eligible if the above criteria are met, but only if the surgical scar does not extend inferior to the nipple line of the breast; language is not a barrier if there are interpreters/family members to translate; patients having had chemotherapy are eligible for this study; exclusion criteria: inability to give informed consent or comply with requirements of the trial; failure of healing of the surgical scar or significant post-operative wound infection; prior radiotherapy to either breast or to the chest; presence of significant connective tissue disease (e.g. systemic sclerosis); known radiation hypersensitivity phenotype (e.g. ataxia telangiectasia); inability to return for assessment at both one week and two weeks following completion of radiotherapy; breast reconstruction; use of mepitel® wound dressing product.

Keywords: skin dose skin fold organ at risk
a controlled study to evaluate the efficacy and the tolerability of a cosmetic active ingredient intended for subjects with atopic dermatitis

Conditions: Mild to Moderate Atopic Dermatitis

Summary: evaluation of safety and clinical efficacy of an active ingredient versus placebo for the treatment of mild to moderate atopic dermatitis (ad) adults.


Eligibility criteria:
main inclusion criteria: * good general health * phototype i to iv * mild to moderate scorad (between 15 and 25) main exclusion criteria: * pregnant/breastfeeding female or who have planned a pregnancy during the study period * positive history for atopy or hypersensitive skin * subjects under systemically pharmacological treatment * subjects under locally pharmacological treatment on the skin area monitored during the test * subjects with congenital or acquired immunodeficiency * subjects under treatment with food supplements which could interfere with the functionality of the product under study * subjects which show other skin alterations on the monitored area except for acne lesions * subjects with known or suspected sensitization to one or more test formulation ingredients
comparative outcomes between imageless robotic-assisted and conventional total knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to compare post-operative mechanical alignment (hip-knee-ankle angle; hka) between imageless robotic-assisted (navio™ robotics-assisted surgical system) and conventional total knee arthroplasty


Eligibility criteria:
inclusion criteria: * primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty * age 50-80 year * patients with osteoarthritis who voluntarily participated in the project exclusion criteria: * patients with osteoporosis * history of inflammatory arthroplathy * previous fracture or open surgery on the same knee * patients with bilateral total knee arthroplasty * patients osteoarthritis with revision surgery
physical activity enhancement using pedometers in copd

Conditions: COPD

Summary: physical activity is reduced in copd affecting morbidity and mortality and the usual advice is not good enough to increase the physical activity level. the aim of the study is to determine the effects of pedometers in the physical level in copd patients.

physical activity is reduced in copd patients and has a negative effect in the morbidity and mortality of this condition. unfortunately, usual advice is not good enough to reverse the sedentary condition in copd patients. pedometers are broadly used to measure and to enhance physical activity in copd but their effects in copd are not well known. the aim of the study is to determine the effects of a program using pedometers as a feedback in stable ex smokers copd patients. patients are recruited for a 3 months individual program promoting daily physical activity enhancement and are randomly assigned either to a pedometer-based program (experimental group) or to usual care (control group, the measurements at the beginning and at the end of the study are: anthropometrics, spirometry, dyspnea, quality of life, exercise capacity and the average one week daily steps. also the number of acute exacerbations during the follow up are recorded.

Eligibility criteria:
inclusion criteria: * copd diagnosis according to gold guidelines * pack year index equal or more than 10 * smoking suspended \> 2 months * older than 40 years old, exclusion criteria: * any chronic condition that does not allow walking * participation in a rehabilitation program * acute exacerbation in the last two months

Keywords: copd physical activity pedometers steps non pharmacological treatment rehabilitation exercise
clotrimazole vs. mycelex® in patients with human insufficiency virus (hiv) infection for the treatment of oropharyngeal candidiasis

Conditions: Candidiasis, Oral

Summary: the objectives of this study are to compare the efficacy and safety of roxane's clotrimazole troches vs. mycelex troches in hiv positive patients with oropharyngeal candidiasis, where this condition has been diagnosed by clinical examination and confirmed by fungal culture.


Eligibility criteria:
inclusion criteria: * documented hiv positive status * clinical examination of oropharynx is consistent with diagnosis of oral candidiasis (such as creamy, white, curdlike patches or erythematous lesions on mucosal surfaces) * findings on direct microscopic examination (gram stain or potassium hydroxide smear) consistent with candida species or positive fungal culture for candida species, with culture obtained in the 2 days preceding initiation of therapy with the study drug * male or female patients ≥ 18 years * for women of childbearing potential: negative blood or urine pregnancy test and agreement to use adequate contraception (investigator's discretion) while on study drug * mental status allows comprehension of instructions for troche administration * written informed consent exclusion criteria: * sings of symptoms suggestive of esophageal candidiasis (such as dysphagia or odynophagia) unless the results of an endoscopic evaluation of the esophagus are negative * presence of perioral lesions only * use of other antifungal agents within 5 days of enrollment to the study * pregnant or lactating women * history of hypersensitivity to imidazole or azole compounds * patient unwilling or unable to be followed at the study center for the duration of the study (3 weeks) * patients has received an investigational drug in the last 30 days * treatment with another investigational drug is planned within the next 3 weeks
understanding ketamine's dissociative effects (kd study)

Conditions: Epilepsy

Summary: the purpose of this study is to understand how ketamine brings about dissociative symptoms.

the goal of this proposed research is to record the effects of ketamine on brain activity to understand the changes that occur during dissociation in epilepsy patients with stereoeeg.

Eligibility criteria:
inclusion criteria: * patient in stanford epilepsy monitoring unit * age \>18 years old. exclusion criteria: * lifetime psychotic or bipolar disorder * inability to speak, read or understand english * pregnant or nursing females * prior adverse ketamine response
a research study looking at how a factor viii medicine called turoctocog alfa pegol (n8-gp) works in people with haemophilia a

Conditions: Congenital Bleeding Disorder; Haemophilia A

Summary: this study will look at how a known study medicine n8-gp works in previously n8-gp treated people with haemophilia a. the aim is to look at how n8-gp works during regular use. participants will get n8-gp. n8-gp has been tested in more than 200 people with haemophilia a for several years. participants will get an injection of n8-gp into a blood vessel, one, two or three times weekly. participants will get more doses if they bleed or if they will need a surgery. the study will last for about 2 years. participants will have at least 9 visits with the study doctor. if participants agree to be in this study, they will get their first injection (in this study) at the first visit. participants will also get an injection at visit 3, 5 and 7. participants will be trained to give all other injections themselves. participants must not use any clotting factors other than n8-gp or any anticoagulants (blood thinners) during the study.


Eligibility criteria:
inclusion criteria: * male patients of all ages with the diagnosis of severe congenital haemophilia a (coagulation factor viii \[fviii\] activity less than 1%) based on medical records * on-going participation in nn7088-3859 (pathfinder2), or nn7088-3885 (pathfinder5) at the time of transfer exclusion criteria: * known or suspected hypersensitivity to trial product including allergy to hamster protein or related products * any disorder, except for conditions associated with haemophilia, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol - current participation in any clinical trial (except nn7088-3859 (pathfinder2) or nn7088-3885 (pathfinder5)) of an approved or non-approved investigational medicinal product
application of clinical metagenomics in the diagnosis of ascites

Conditions: Ascites Infection

Summary: infection of the ascitic fluid is a serious complication associated with high morbidity and mortality. this fluid is often colonized with bacteria that can cause infection of the peritoneum and possibly sepsis. many bacteria of the human intestinal microbiome can't be cultured by standard methods; therefore it seems likely that many of the relevant bacteria are not discovered in routine diagnostics, but may be relevant to pathogenesis. culture-independent approaches such as ngs (next generation sequencing) have in principle made it possible to study or prove complex microbial colonization. because ngs is a relatively new technology, microbiological diagnostic protocols need to be further customized and refined to integrate with the standard diagnostic workflow, if necessary. for microbiological diagnostics, material is collected from the appropriate ascites patients and sent for microbiological diagnostics. afterwards the cultural diagnostics are carried out as part of the patient care at the university hospital. in this study the investigators plan to use these samples to analyze and compare the presence of bacteria by ngs in parallel to the culture diagnostics, and then compare it to the patients' gut microbiome, to understand the possible effect of the microbiome on ascites pathogenesis and outcome.


Eligibility criteria:
inclusion criteria: * male and female patients ≥ 18 years of age * samples from patients who have ascites puncture to exclude infection * written consent of the patient after clarification exclusion criteria: * minor patients * non-consenting patients * samples without sufficient residual material after standard diagnostics * samples from patients who have not consented to the examination.

Keywords: metagenomics
rollover study to evaluate the safety and efficacy of long-term treatment with lumacaftor in combination with ivacaftor

Conditions: Cystic Fibrosis

Summary: study 110 is a phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del-cf transmembrane conductance regulator (cftr) mutation and who participated in study 109 (nct02514473) or study 011b (nct01897233). study 110 is designed to evaluate the safety and efficacy of long term treatment of lumacaftor in combination with ivacaftor.


Eligibility criteria:
inclusion criteria: subjects entering the treatment cohort must meet both of the following criteria: * completed study visits up to week 24 of study 109 or week 26 of study 011b and did not permanently discontinue treatment * willing to remain on a stable cf medication through the safety follow-up visit. subjects entering the observational cohort must meet 1 of the following criteria: * completed 24 weeks of study drug treatment in study 109 or completed 24 weeks of study drug treatment and the week 26 safety follow up in study 011b. * received at least 4 weeks of study drug and completed visits up to week 24 of study 109 or week 26 of study 011b. exclusion criteria (treatment cohort only): * history of any comorbidity or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject (e.g., cirrhosis with portal hypertension). * pregnant and nursing females. * sexually active subjects of reproductive potential who are not willing to follow the contraception requirements. * history of drug intolerance in the prior study that would pose an additional risk to the subject in the opinion of investigator * history of poor compliance with study drug and/or procedure in the previous study as deemed by the investigator. * participation in an investigational drug trial (including studies investigating lumacaftor and/or ivacaftor).
evaluation of eustachian tube function with 226 and 1000 hz probes in children undergoing tonsillectomy ± adenoidectomy

Conditions: Tonsillar Hypertrophy; Eustachian Tube Dysfunction; Tympanic Membrane Disorder; Eustachian Tube Dysfunction of Both Ears

Summary: in children undergoing tonsillectomy ± adenoidectomy without eustachian dysfunction, the objective is to control tubal functions with tympanometry utilising probes at 226 hz and 1000 hz, as well as measuring the ipsilateral and contralateral acoustic reflexes with a 226 hz probe. an eustachian function test with a 226 hz probe (automatic williams test) and play audiometry are to be conducted on young children, while pure tone audiometry is to be conducted on older children, in the preoperative period, on the first day after surgery and in the second week after surgery. the primary objective is to ascertain whether the tubal functions, which are hypothesised to be impaired on the first day, return at the latest in the second week, with all tests evaluating the eustachian tube both directly and indirectly. the secondary objective is to determine whether this recovery occurs earlier with the 226 hz probe or the 1000 hz probe.


Eligibility criteria:
inclusion criteria: * 4-15 years old child patient * no preoperative tubal dysfunction detected in the patient * willingness to participate in the study by the patient and his/her parents * the patient has no craniofacial anomaly, genetic disorder, cleft palate-lip anomaly * no bleeding disorder or disease exclusion criteria: * \ 15 years old paediatric patient * tubal dysfunction detected preoperatively * not wanting to participate in the study at any stage of the study * the patient has craniofacial anomaly, genetic disorder, cleft palate-lip anomaly * having a bleeding disorder or disease

Keywords: eustachian tube tubal dysfunction tympanometry high-frequency tympanometry eustachian tube dysfunction
ai recognition of important structures in otolaryngological surgery

Conditions: Otolaryngological Diseases Requiring Mastoidectomy; Middle Ear Surgery, Endolymphatic Sac Surgery, Cochlear Implant, Labyrinthectomy, Petrous Apex Lesions, Facial Nerve Surgery, and Lateral Skull Base Tumors

Summary: developing a system for artificial intelligence to recognize anatomical landmarks in otolaryngological surgery, enabling real-time tracking of critical temporal bone structures during surgery.

take the example of the al recognition and prediction of the incus, external semicircular canal, facial nerve, and facial nerve recess. within the defined surgical area, annotated data points are utilized to identify and segment the incus and the lateral semicircular canal based on their relative positions and angles concerning the posterior wall of the external auditory canal and the surrounding tissues. detailed descriptions of the incus and lateral semicircular canal within the surgical area include: incus: the incus is a small anvil-shaped bone located in the middle ear. it connects to the malleus laterally and the stapes medially. identifying the incus accurately is crucial due to its proximity to the facial nerve and its involvement in the ossicular chain that transmits sound vibrations. lateral semicircular canal: this is one of the three semicircular canals in the inner ear, oriented horizontally. it is involved in detecting rotational movements of the head. proper identification is necessary to avoid damaging the canal, which could result in vertigo or balance issues. input features include further contrast adjustment and localized magnification of images. the enhanced images are classified and localized using the trained model, and the consistency of multiple frames is utilized to determine the final positions of the facial nerve and the facial recess. statistical analysis is conducted to predict the positions of the facial recess relative to the incus and lateral semicircular canal, providing reference information for surgeons. the system continuously monitors changes in the surgical area, offering dynamic feedback and optimizing the model's accuracy and robustness through incremental training.

Eligibility criteria:
inclusion criteria: 1. performing otolaryngological surgeries such as cochlear implantation, endolymphatic sac decompression, semicircular canal plugging, and acoustic neuroma surgery using a microscope. 2. microscopic exposure provides a comprehensive and clear view of the surgical area within the temporal bone. exclusion criteria: 1. no surgical video recording available. 2. unclear visualization of the surgical area during microscopic otolaryngological procedures. 3. incomplete visualization of the entire surgical process. 4. patients who did not undergo high-resolution temporal bone ct at our hospital or shenzhen deep bay hospital.
safety & immunogenicity of pneumococcal vaccine 2189242a in children aged 12-23 months at the time of first vaccination

Conditions: Infections, Streptococcal

Summary: this study will assess the safety, reactogenicity and immunogenicity of different formulations of gsk biologicals' pneumococcal vaccine 2189242a when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (gsk1024850a vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature \>40.0°c).


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent(s)/legally acceptable representative(s) (lar) can and will comply with the requirements of the protocol * male or female between, and including, 12 and 23 months of age at the time of the first vaccination. * written informed consent obtained from the parents/lar(s) of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s). * previous vaccination against s. pneumoniae since birth. * history of any hypersensitivity reaction following any previous vaccination. * eczema and any history of allergy * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus infection. * a family history of congenital or hereditary immunodeficiency. * major congenital defects or any chronic illness. * history of any neurologic disorders or seizures. * acute disease and/or fever at the time of enrolment. * fever is defined as temperature \>= 37.5°c on oral or axillary setting, or \>= 38.0°c on rectal setting. * subjects with a minor illness without fever may be enrolled at the discretion of the investigator. * administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period. * child in care.

Keywords: immunogenicity toddlers pneumococcal vaccine haemophilus influenzae safety streptococcus pneumoniae streptococcus pneumoniae vaccines