Kornimate/medical-research-clean huggingface dataset:
menopause and oral microbiome

Conditions: Menopause

Summary: the study examines the saliva and dental plaque microbiome of women aged 35-65 in two groups: postmenopausal (case) and premenopausal (control). for this purpose, illumina platform to sequence 16s rrna gene regions will be used. the data will be analyzed using the qiime2 bioinformatics tool. serum estradiol levels will be determined by the elisa method. the investigators will examine the relationship between microbiome data (alpha diversity, beta diversity, and relative abundance) and menopausal status, estradiol levels, and periodontal health status using linear statistical models. clinical samples of the study will be collected at ege university, and the laboratory studies and sequence analysis will be conducted at the forsyth institute in boston. to obtain longitudinal data besides the cross-sectional data, the investigators will contact the participants of a previous study from 2019, whose saliva, dental plaque, and serum samples are currently being stored at -80 °c, and ask them to participate for a second sampling.


Eligibility criteria:
inclusion criteria regularly mensturating women over 35 years of age postmenopausal women under 65 years of age - exclusion criteria: - antibiotic useage in last 3 months being in menopausal transition phase
covid19 outcomes in myeloma and the impact of vaccines

Conditions: Multiple Myeloma

Summary: the covid-19 pandemic has had an outsized impact on individuals with underlying social and medical vulnerability, leading to increased rates of severe disease, hospitalization, and death in these groups. participants with underlying immune compromise, such as those with multiple myeloma, represent one such group. the advent of vaccines against sars-cov-2 has significantly limited morbidity and mortality across all groups, but the effectiveness of vaccination in individuals who are less likely to mount sufficient antibody response is uncertain. for this reason, booster vaccines have been recommended for those with underlying immune compromise. however, several key gaps remain in our understanding of how to best protect these individuals. there is a dearth of real-world evidence about the effectiveness of vaccination and boosters in patients who are immunocompromised, and very little information specifically about the recently approved mrna boosters. additionally, rates of vaccination and booster uptake in the united states remain low. a rapid, decentralized method of ascertaining information related to booster vaccine response and adverse events related to vaccines and covid-19 infection is critical not only to answer questions about the booster vaccines, but to develop an infrastructure for answering similar questions about future vaccines or other diseases.

the purpose of this project is to implement and establish the feasibility of a decentralized real-world evidence study network for patients with multiple myeloma and to monitor outcomes related to covid-19 infection in this immunosuppressed population. subjects with multiple myeloma will be invited to participate. the electronic portal will handle all consenting activities. participants will be asked to complete specific study procedures electronically, including permission for electronic health record (ehr) data transfer. participants will be asked to complete electronic questionnaires periodically.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma per the international myeloma working group and currently receiving active treatment for any phase of the disease, including initial therapy, maintenance, or relapsed disease. * access to the internet * an active patient portal (or willingness to activate) * willing to electronically sign the study-specific informed consent and authorization form exclusion criteria: * non-english speaking * lack of internet access * cognitive impairment precluding ability to provide informed consent

Keywords: myeloma covid-19 vaccine cosmic
treatment of desmoid fibromatosis with arterial embolization

Conditions: Desmoid Fibromatosis

Summary: desmoid fibromatoses are rare and locally aggressive mesenchymal tumors. the current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. these studies report promising results through the use of chemoembolization, that is, arterial embolization using particles loaded with chemotherapy. instead, the type of treatment we propose would consist of injection of embolizing material without the use of chemotherapy, based on the positive results we have consistently reported over the years on arterial embolization of musculoskeletal tumors.

desmoid fibromatoses are rare (1-2 cases/million per year) and locally aggressive, characterized histologically by monoclonal myoblasts present in abundant stromal tissue.the current therapeutic strategy has abandoned primary resection, as recurrences after resection are common and often their phenotype is more infiltrative. nonsurgical approaches remain suboptimal. for asymptomatic disease, current guidelines suggest an initial period of active surveillance. the current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. these studies report promising results through the use of chemoembolization, that is, arterial embolization using particles loaded with chemotherapy. instead, the type of treatment we propose would consist of injection of embolizing material without the use of chemotherapy, based on the positive results we have consistently reported over the years on arterial embolization of musculoskeletal tumors. doxorubicin is routinely used in the treatment of soft tissue sarcomas and other mesenchymal malignancies. its use against desmoid fibromatosis is effective but associated with hematologic, gastrointestinal, and cardiac toxicity. consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing, or life-threatening fibromatoses.

Eligibility criteria:
inclusion criteria: * patients of both sexes aged ≥ 12 years * fibromatosis demsoid symptomatic and in active phase (documented growth at last follow-ups) * patients not eligible for surgery or cryoablation * patients who have had embolization surgery for fibromatosis desmoide from 01/01/2023 to date and all new patients listed for this type of treatment. * signature of informed consent to the study exclusion criteria: * patients with life expectancy \<3 months or severely impaired status functional status (asa 4) * patients with fibromatosis not in active phase, documented clinically and by investigations imaging (mri, ct) * patients with coagulation deficiency or plateletopenic disease * patients with documented active infection * incompatibility to performing mri examination.

Keywords: desmoid fibromatosis embolization
post operative analgesia and patient satisfaction

Conditions: Postoperative Pain; Patient Satisfaction; Analgesia

Summary: to understand how patients perceive the quality of care they receive when given different post-operative analgesic medications. specifically the investigators want to assess whether patients who receive non-opioid analgesia following surgery endorse appropriate quality and satisfaction with their care compared to those who receive opioid medication.

it is routine practice to give analgesic medication after any surgical procedure to provide adequate pain control for patients. however with the increase in abuse of opioid prescription medications, physicians have given a new emphasis to different pain regimens that aim to limit the use of opioid medications. the investigator's previous clinical trial demonstrated that for patients undergoing outpatient otolaryngology procedures, not only does ibuprofen provide equally effective analgesia compared to opioid medication but it can also decrease overall opioid requirement. in the current proposed study, the investigators wish to build on previous work. the investigators hypothesize that with the addition of acetaminophen to ibuprofen, patients undergoing outpatient otolaryngology procedures may not require opioid analgesia at all. while numerous studies corroborate these results, there is little information about patients' satisfaction with their care in light of a shifting emphasis on decreasing opioid prescription. the primary goal of the current study is to better understand patients' perception of care and level of satisfaction when given opioid versus non-opioid postoperative analgesia. if there is conflicting data with regards to patients reporting adequate pain control but poor satisfaction, then perhaps further public health intervention may be necessary to provide additional patient education to help re-establish appropriate and safe patient expectations for postsurgical analgesia.

Eligibility criteria:
inclusion criteria: * patients between the ages of 18 and 89 years of age * patients undergoing the following outpatient procedures at a lluhs associated surgical facility: * total or partial thyroidectomy * parathyroidectomy * parotidectomy * submandibular gland excision * neck mass excision * facial mass excision * mohs defect repair * excision of cutaneous lesions * other surgeries may qualify and will be assessed on a case by case basis. exclusion criteria: * patients under 18 years old or older than 89 years old * those allergic to hydrocodone, acetaminophen, or nsaids * patients who are pregnant * patients with chronic medical conditions including hepatic/renal disease that precludes their ability to utilize the study medications.

Keywords: otolaryngology head and neck surgery outpatient surgery same day surgery post operative pain patient satisfaction post operative analgesia nsaid acetaminophen hydrocodone
ser-109 versus placebo to prevent recurrent clostridium difficile infection (rcdi)

Conditions: Clostridium Difficile

Summary: the study will involve administering the study drug as a single dose of study drug or placebo. this study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent cdi.

ecospor is a phase 2, multicenter, randomized, double blind, placebo controlled clinical study with 2 treatment arms (ser-109 or placebo). patients who have diarrhea and a positive c. difficile test result on a stool sample, and who have responded to standard of care antibiotic treatment will receive study drug on day 1. those patients who experience a recurrence of cdi up to 8 weeks after ser 109 or placebo treatment will be offered an opportunity to enroll in an open label ser 109 extension study (study seres 005).

Eligibility criteria:
inclusion criteria: 1. signed informed consent, indicating that the patient understands the purpose of and procedures required for the study. patients who are unable to provide informed consent will not be included in the study. 2. male or female patients ≥ 18 years. 3. ≥ 3 episodes of cdi within the previous 9 months, inclusive of the current episode with documentation of ≥ 2 episodes. exclusion criteria: 1. female patients who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study. 2. known or suspected toxic megacolon and/or known small bowel ileus. 3. active irritable bowel syndrome with diarrhea within the previous 12 months. 4. major gastrointestinal surgery (eg, significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy) or any history of total colectomy or bariatric surgery. 5. history of inflammatory bowel disease (ulcerative colitis, crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 24 months. 6. admitted to or expected to be admitted to an acute care facility or intensive care unit for medical reasons (not just boarding). patients discharged from an acute care facility before day 1 or residing in nursing homes or rehabilitation facilities may be enrolled. 7. concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor).
investigation of gait parameters in health and neurological disease under varying locomotor conditions

Conditions: Gait Analysis in Neurological Disorders

Summary: in the cross-sectional component of this study, our overall objective is to gather a large pool of data from which we can generate gait "profiles". these profiles will consist of a constellation of gait (+/- electrophysiological) parameters associated with a particular neurological diagnosis or specific lesion(s) in neuroanatomical systems. once developed, these profiles can be compared for differences and similarities; allowing insights into the specificity of the effect on gait of a given diagnosis or lesion in the case of the former and redundancy of neuroanatomical systems in that of the latter. a longitudinal component of the study will look at the evolution of gait parameters over time in a group of patients with spinal cord injury.


Eligibility criteria:
inclusion criteria: patients: * age 18 - 80 * written, informed consent * one of the following established diagnoses: unilateral stroke affecting motor system, parkinson syndrome, cerebellar disease, vestibular dysfunction, spinal cord injury, multiple sclerosis * brain and whole spine t1, t2 \& flair magnetic resonance imaging performed within the last four months and available for study purposes or no contraindications to performing these scans healthy subjects: * age 18 - 80 * written informed consent exclusion criteria: patients: * colour-blindness * known to be pregnant or breastfeeding * body mass index (weight in kg/height in metres squared) \>40 unable to walk 50m within 6 minutes (with or without walking aids) inability to undertake any component of the trial protocol * terminal diagnosis with life expectancy less than six months * cognitive disturbance defined as mmse \< 25 clinically significant comorbidities such as severe cardiovascular, pulmonary or malignant disease healthy subjects: * colour-blindness * known to be pregnant or breastfeeding * body mass index (weight in kg/height in metres squared) \>40 unable to walk 50m within 6 minutes * reliance on walking aids / prostheses for mobilisation * significant neurological or orthopaedic diagnosis with potential impact on gait // previous operations on the lower limbs or spine with potential impact on gait inability to undertake any component of the trial protocol clinically significant conditions such as severe cardiovascular, pulmonary or malignant disease
bringing acute and wellness care to underserved populations using traditional chinese medicine

Conditions: Pain Management; Traditional Chinese Medicine

Summary: at a time when there is so much focus in the united states on reducing the cost of health care delivery while maximizing the effectiveness of health care performance, traditional chinese medicine (acupuncture, herbal treatment, and accessory techniques) offers decision makers a tantalizing option. traditional chinese medicine differs from its biomedical counterpart in that it is highly portable, inexpensive to administer, relies on a conversational diagnostic inquiry system to arrive at differential diagnosis for its patients, and has very few reported side effects associated with treatment. the world health organization cites acupuncture has a proven and effective treatment for 28 diseases/disorders including stroke, pain management issues and rheumatoid arthritis; the who lists another over 65 diseases for which the therapeutic effect of acupuncture has been shown but for which further proof is needed including alcohol dependence, cancer pain and diabetes mellitus. with the completion of this pragmatic clinical trial and introduction of the constant care method of health care delivery to underserved communities on chicago's south side, the investigators can both utilize an effective plan of health care delivery, advance the research needed to effectively utilize traditional chinese medicine as a low cost therapeutic option in this country, and successfully treat disenfranchised populations that have been traditionally overlooked and that deserve a better health and wellness care future.


Eligibility criteria:
inclusion criteria: * adults age 21 and over exclusion criteria: * children * pregnant women

Keywords: traditional chinese medicine acupuncture
artificial intelligence screening on patients with primary angle closure glaucoma

Conditions: Ophthalmopathy

Summary: the tomey casia (tomey corporation, nagoya, japan) is a novel rapid imaging device that captures high-quality imaging of the entire anterior chamber of the eye over detailed imaging of a single section. in this prospective study, we want to investigate and compare the anatomical structure of the drainage angle of the eye in patients with different types glaucoma using tomey machine. this study gives us a better understanding of the predictability, validity and accuracy of tomey machine in the diagnosis of different types of glaucoma. moreover, the data collected here will be used to create an artificial intelligence (ai) platform to screen certain type of glaucoma.

patients ≥18 years old from ophthalmic clinics with or without glaucoma were enrolled to this respective observational clinical study. however, patients with any history of eye surgery (except cataract surgery) including laser procedure were excluded. the investigators will review patients' medical chart and update any medical history in your medical record. if new scans are needed, investigators will do them at the time of patients' current visit and it will require about 30 mins. casia ss-oct (casia 2) is a non-contact scan of the front of the eye with higher resolution and provides deeper, wider and three- dimensional views. it is the newest scan machine. it is not fda-approved but is approved in many other countries including japan for patient use. we may perform the scan in the light and dark condition. we may also perform the routine scan to capture images of the anterior part of the eye for comparison purpose. the results of the scanned data will be among patients' medical records. age, sex and ethnicity within your medical records will also be used for the analysis.

Eligibility criteria:
inclusion criteria: * patient with or without glaucoma exclusion criteria: * patients with any history of eye surgery (except cataract surgery) including laser procedure. * age \< =18 years

Keywords: primary angle-closure glaucoma artificial intelligence
dose response of inhaled tacrolimus in patients with moderate persistent asthma

Conditions: Asthma, Bronchial; Bronchial Asthma

Summary: this study will evaluate the efficacy and safety of tacrolimus in patients with asthma.


Eligibility criteria:
inclusion criteria: * diagnosis of asthma * patients treated with inhaled corticosteroid * fev1 (forced expiratory volume in 1 second)\>60% to 80% exclusion criteria: * respiratory infection within 2 weeks * asthma exacerbation within 90 days

Keywords: tacrolimus immunosuppressant anti-asthmatic drug administration, inhalation
a study of the efficacy, safety and tolerability of cnto 1959, a human anti-il 23 monoclonal antibody in participants with palmoplantar pustulosis

Conditions: Palmoplantaris Pustulosis

Summary: the purpose of this study is to assess the efficacy, safety, and tolerability of cnto 1959 following subcutaneous administration in participants with palmoplantar pustulosis.

this will be a double-blind (participants and study personnel will not know the identity of the treatments given), multicenter study that is placebo-controlled (a placebo is identical to a study treatment, but has no active ingredients). participants will be randomly assigned to 1 of 2 treatment groups (cnto 1959 or placebo). the total duration of participation will be approximately 30 weeks, including a screening period of about 6 weeks before dosing. participant safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participant has a diagnosis of palmoplantar pustulosis at screening (participants with concurrent extra-palmoplantar lesions \[includes plaque-type psoriasis lesions\] and/or pustulotic arthro-osteitis \[pao\] can also be included) * participant has active lesions on the palms or soles at screening and baseline * participant has inadequate response to treatment with topical steroid and/or topical vitamin d3 derivative preparations and/or phototherapy and/or systemic etretinate prior to or at screening * participant has a palmoplantar pustulosis severity index (ppsi) score of 7 or greater at screening and baseline * at screening, the results of laboratory blood tests must be within protocol-specified limits exclusion criteria: * history of or current signs of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurologic, cerebral, or psychiatric disease * participant has unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months or a cardiac hospitalization within the last 3 months prior to screening * history of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (eg, recurrent pyelonephritis), fungal infection (eg, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers * participant has or has had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized or received intravenous (iv) antibiotics for an infection during the 2 months prior to screening * participant has or has had herpes zoster within the 2 months prior to screening

Keywords: palmoplantaris pustulosis cnto 1959 psoriasis anti-il 23 monoclonal antibody
early surgeon experience with robotic-assisted inguinal hernia repair

Conditions: Hernia, Inguinal

Summary: the primary objective of this study is to evaluate the progression of surgeon efficiency and proficiency of traditionally open or laparoscopic surgeons performing robotic-assisted inguinal hernia repair throughout their learning curve.

this is a prospective, multi-center, observational pilot study evaluating surgeon efficiency and proficiency of traditionally open or laparoscopic surgeons performing robotic-assisted inguinal hernia repair. the study will focus on surgeon intraoperative efficiency and technical performance outcomes as well as conversions, intraoperative complications, and mental and cognitive workload. surgeon subjects will be assessed for technical proficiency through a study specific technical proficiency form and the gears scale by independent surgeons.

Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent by adult surgeon subject 2. practicing general surgeon with no or limited robotic assisted experience 3. full access to the da vinci surgical system at hospital and ability to perform robotic cases as needed 4. willingness to participate in all aspects of the study exclusion criteria: 1. condition(s) that, in the opinion of the investigator, may prevent completion of the study or protocol requirements