Kornimate/medical-research-clean huggingface dataset:
urine sample collection from non pregnant peri and post-menopausal women

Conditions: Pregnancy

Summary: this is a sample collection study, participants will be required to collect one (if last menstrual period ≥12 months) or two (if last menstrual period \<12 months) urine samples and return them to the study site, together with collection sample information. participants having a menstrual cycle within the last 6 months will also be required to provide follow-up information on pregnancy status and date of next menstrual bleed.

each subject will be provided with a urine sample collection container, a transport container, barcode labels, prepaid envelopes and a full set of study instructions, together with the materials required to facilitate the collection of a follow-up urine sample and completion of follow up form, where applicable. subjects admitted into the study that are unsure of their pregnancy status will be provided with a marketed clearblue hpt, to test for pregnancy prior to beginning the study. if a subject informs the trial site that they have become pregnant prior to urine sample collection, they will be withdrawn from the study and no urine sample will be collected. the subject will return their materials to the study site, and the co-ordinator will complete the exit form. subjects will be required to collect a urine sample, label their sample (as soon as collected) with the appropriate bar-coded label provided and return this to the study site. where it is not possible to return the sample as soon as collected, urine samples must be stored in a domestic fridge in the container provided for a maximum of 1 week and then sent to the study site at their earliest convenience. subjects will receive follow-up to establish pregnancy status unless ≥ 12 months from their last menstrual period (lmp). on completion of the study, subjects will be reimbursed for their participation. it is anticipated that sample collection will be carried out remotely (i.e. at the volunteers home) but volunteers may attend the study site for sample collection should they require.

Eligibility criteria:
inclusion criteria: * known to be not pregnant, * willing to give consent exclusion criteria: * pregnant or breastfeeding, * pregnant within last 2 months, * having treatment for infertility, * taken hormonal contraception containing hcg in last month, * using hormonal contraception within last month, * previously taken part in sample collection study for sdp (providing 1-7 samples).

Keywords: pregnancy
treatment for teachers with vocal fatigue

Conditions: Vocal Fatigue; Treatment

Summary: teachers are a population at high risk for voice disorders given their occupational demands. in a teaching career, a common debilitating symptom among all vocal symptoms experienced is - vocal fatigue, impacting teachers' occupational performance and increasing health care costs. it is therefore essential to identify potential treatment options to alleviate the symptom of vocal fatigue. the purpose of this study is to utilize a body-system level cardiovascular training protocol in comparison to traditional voice production training to alleviate the symptoms of vocal fatigue.


Eligibility criteria:
inclusion criteria: * female teachers between the ages of 21-60 years female instructors and college professors between the ages of 21-60 years * a score of ≥ 15 on factor 1 of the vfi (tiredness and avoidance of voice use) or a score of ≤ 5 on factor 3 of the vfi (improvement of symptoms or lack thereof with rest) * sedentary- wherein participants will need to be completing mild intensity cardiovascular exercise less than 150 minutes in less than 5 days per week exclusion criteria: * trained athletes * trained singers * smoking in the past 6months * prior history of a vocal fold pathology and current vocal fold pathology
managerial and environmental risk for covid 19 in french long term care institutions

Conditions: Covid19

Summary: rempar ehpad study addresses environmental and managerial factors associated with an outbreak of covid 19 in french long term care institutions in the spring of 2020. the survey used a mixed methodology, combining qualitative and quantitative approaches, with a questionnaire send to all identified institutions (n=501) and qualitative interviews with facility directors (n=21).

1. declarative retrospective survey : a questionnaire was e-mailed to all identified institutions, with 3 reminders in one month. it included 39 questions concerning : * morbidity and mortality linked with covid-19 * structural features of the facility (location, architecture, residents characteristics) * human resources * crisis management (visits and circulation restrictions, personal protective equipment) a statistical analysis by logistic regression will be made, to identify explanatory variables for the occurrence of at least one covid 19 infection among the residents. 2. qualitative survey : the investigators conducted semi-directed face-to-face interviews with facility directors. the investigators realized a purposive sample to assure maximal variability of the facilities (location, size, status, severity of the outbreak). the interview guide focused on structural, organizational, and human factors at stake in outbreak management, to identify incentives and obstacles associated with an easier crisis management.

Eligibility criteria:
inclusion criteria: * long term care institution (ehpad) in britain, france, exclusion criteria: -

Keywords: covid19 elderly long term care crisis management france
overview of botriomycoma in children with a central line: epidemiology, risk factors, treatments

Conditions: Home Parenteral Nutrition; Intestinal Failure; Central Line; Botriomycoma; Infection; Sepsis; Antibiotics

Summary: botriomycomas are frequent benign tumors in children. their appearance on the central catheter orifice is a known event in clinical practice, but one that has been little studied. this lesion could lead to changes in pathways and an increase in the number of sepsis events, which would promote thrombosis and thus depletion of venous capital in patients who have been dependent on a central line for many years. this study is a pilot study which will enable us to better identify the risk factors for the development of such a tumour, and to take stock of the different treatments used and their respective efficacy.


Eligibility criteria:
inclusion criteria: * home parenteral nutrition patients * never diagnosed with an episode of botriomycoma on their central line * 0 to 18 years of age at diagnosis exclusion criteria: * botriomycoma more than 10 years old at time of data collection (or lack of data) * patient over 18 years of age * not on home parenteral nutrition patients
effects of native collagen type 2 treatment

Conditions: Knee Osteoarthritis

Summary: the aim of this study was to evaluate symptomatic efficacy of native collagen type 2 on joint pain and function and its effects on urinary biological markers related to cartilage degeneration in patients with knee osteoarthritis.

39 patients diagnosed with knee osteoarthritis were separated into two groups. the 1st group includes 19 patients given 1500mg/day paracetamol, the 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months.pretreatment and posttreatment visual analog scale, western ontario and mcmaster universities osteoarthritis index (womac), 20-m walking time and short form-36 (sf-36), coll2-1, coll2-1no2 and fibulin-3 levels in urine were compared.

Eligibility criteria:
inclusion criteria:patients aged 45-70 years with the diagnosis of primary knee oa according to the american college of rheumatology (acr) criteria, kellgren lawrence radiological stage ii or iii and knee pain - exclusion criteria:patients with intraarticular injections or physical therapy within the last year, a previous lower extremity surgery, oral treatment with glucosamine chondroitin or other natural health products within the last month, serious concomitant systemic diseases, peripheral or central neurological disorder, hypersensitivity to paracetamol or se¬vere cardiac, renal, hepatic, hematologic disease -

Keywords: knee osteoarthritis, native collagen type 2, paracetamol
proton craniospinal irradiation with bone sparing to decrease growth decrement from radiation

Conditions: Brain Tumor

Summary: this research study is studying proton radiation as a possible treatment for brain tumor that requires radiation. the radiation involved in this study is: -proton radiation

this research study is a pilot study to determine whether using proton therapy in participants that require craniospinal radiation (whole brain and spinal cord radiation therapy) with sparing of the bony spine will work. this is the first time investigators are examining bone sparing proton therapy in pediatric craniospinal radiation. the fda (the u.s. food and drug administration) has not approved proton radiation for this specific disease but it has been approved for other uses. in this research study, the investigators are studying proton radiation in participants that require craniospinal radiation. the standard of care for this procedure is photon radiation, which is very similar to proton radiation. the investigators believe that the precision of proton radiation may help to reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue

Eligibility criteria:
inclusion criteria: * age ≥ 3 years and ≤ 18 years at the time of registration * histologically proven malignancy necessitating cranio-spinal irradiation. this will include patients with a diagnosis of medulloblastoma, supratentorial primitive neuroectodermal tumor (spnet), germ cell tumor (gct), disseminated ependymoma, embryonal tumor with abundant neuropil and true rosettes (etantr), atypical teratoid/rhabdoid tumor (atrt), and disseminated low-grade glioma (lgg). * life expectancy ≥ 12 months. * signed informed consent document and assent when appropriate. * hgb of \> 10 g/l and plt count \> 80 k/ul exclusion criteria: * any prior therapeutic radiation therapy \> 500 cgy has been delivered. * individuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 5 years and are deemed by the investigator to be a low-risk for recurrence of that malignancy; or, have had only cervical cancer in situ, or basal cell or squamous cell carcinoma of the skin. * any major uncontrolled or poorly controlled intercurrent illness that would limit compliance with study requirements. * pregnant females are excluded. females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy. * patients that receive concurrent chemotherapy with the exception of concurrent vincristine.

Keywords: brain tumor
segmental resection combined with dep regimen for ebv-hlh patients with intestinal involvement

Conditions: Hemophagocytic Lymphohistiocytosis; Epstein-Barr Virus; Bowel Resection

Summary: ebv-hlh is a rare disease with high mortality, especially for those with intestinal involvement. in order to reduce disease burden and improve survival of these patients, we conduct a prospective observational study to explore the efficacy and safety of segmental resection combined with the dep regimen.

epstein-barr virus associated hemophagocytic lymphohistiocytosis is a rare disease with high mortality, especially for those with intestinal involvement. some of them still died despite early control of the disease due to severe complications, such as gastrointestinal bleeding. in order to reduce disease burden and improve survival of these patients, we conduct a prospective observational study to explore the efficacy and safety of segmental resection combined with the dep regimen.

Eligibility criteria:
inclusion criteria: * met hlh-2004 diagnostic criteria; * ebv-dna in the peripheral blood \> 1000 copies/ml or ebv-encoded small rna (eber) detected in tissues; * imaging revealed severe intestinal lesions and biopsy confirmed ebv-encoded small rna (eber) in the tissues; * age \>18 years old, gender is not limited; * estimated survival time \> 1 month; * informed consent obtained. exclusion criteria: * active infections (viral, bacterial, fungal or parasitic); * diagosed with malignant tumos within 5 years； * uncontrolled symptoms or other diseases including, but not limited to, unstable angina pectoris, arrhythmia, respiratory failure, severe hepatic or renal insufficiency, severe coagulation dysfunction, mental illness, or other conditions deemed by the attending physician to be contraindications to surgery; * heart function above grade ii (nyha); * severe myocardial injury：tnt、tni、ck-mb \> 3 uln; * accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicin above 800mg/m2 or the patients treated with anthracycline induced cardiovascular disease; * pregnancy or lactating women; * allergic to pegylated liposomal doxorubicin and etoposide; * hiv antibody positivity; * acute or chronic active hepatitis b (hbsag positivity, hbv dna negative acceptable), acute or chronic active hepatitis c (hcv antibody negatively acceptable; hcv antibody positivity, hcv rna negative acceptable); * participate in other clinical research at the same time; * the researchers considered that patients are not suitable for the study.
dose escalation study to evaluate the penetration and pharmacodynamic effects of baminercept in the cerebrospinal fluid (csf)and safety in subjects with secondary progressive multiple sclerosis (spms)

Conditions: Secondary Progressive Multiple Sclerosis

Summary: this is a prospective, randomized, multicenter, dose escalation study to determine subject safety, pharmacokinetic, and pharmacodynamic responses in patients with spms

this study is a prospective, randomized, placebo-controlled, blinded, dose escalation study of 3 to 4 cohorts with defined number of patients per cohort receiving active drug or placebo for a period of 4 months followed by safety monitoring for an additional 4 months after the last dose

Eligibility criteria:
inclusion criteria: * a diagnosis of secondary progressive multiple sclerosis * aged 18 to 57 years old, at the time of informed consent exclusion criteria: * history of clinically important (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, immune, psychiatric, hepatic, renal or hematologic insufficiency or any other major disease other than ms ( multiple sclerosis) * inability in the opinion of the investigator to comply with study requirements * other protocol-defined criteria may apply
distal femur fx: orif(open reduction and internal fixation) vs dfr (distal femur replacement total knee arthroplasty)

Conditions: Distal Femur Fracture

Summary: supracondylar femur periprosthetic fractures about a total knee arthroplasty (tka) are a catastrophic and challenging complication of tka and unfortunately are increasing in incidence. fixation of these fractures can be challenging due to altered anatomy for the tka and the presence of the metallic femoral component and have a relatively high complication rate. as a result, some surgeons elect to treat these fractures with a distal femur replacement total knee arthroplasty (dfr). the purpose of this study is to prospectively evaluate periprosthetic femur fractures treated with orif or dfr and compare various outcomes measures (get up and go times, koos jr score)

supracondylar femur periprosthetic fractures about a total knee arthroplasty (tka) are a catastrophic and challenging complication of tka and unfortunately are increasing in incidence. fixation of these fractures can be challenging due to altered anatomy for the tka and the presence of the metallic femoral component and have a relatively high complication rate. as a result, some surgeons elect to treat these fractures with a distal femur replacement total knee arthroplasty (dfr). several small retrospective studies have compared outcomes with mixed results. to the authors' knowledge there are no prospective studies evaluating the outcomes after treatment of periprosthetic distal femur fractures. the purpose of this study is to prospectively evaluate periprosthetic femur fractures treated with orif or dfr and compare various outcomes measures (get up and go times, koos jr score).

Eligibility criteria:
inclusion criteria: * english speaking patients * 55 years or older with su type ii or su type ii periprosthetic femur fractures requiring surgical intervention and are medically fit to undergo surgical intervention exclusion criteria: * patients with an active total knee prosthetic infection * patients unable to undergo surgical intervention * patient with an open fracture * non-english-speaking patients * oncologic/pathologic fracture * poly-trauma patient (or other associated major orthopaedic injuries)
a study of oral lgh447 in patients with relapsed and/or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the primary purpose of this dose escalation study is to estimate the maximum tolerated dose (mtd) and/or recommended dose for expansion (rde) of lgh447 as a single agent when administered orally once daily to adult patients with multiple myeloma (mm).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of multiple myeloma that is relapsed and/or refractory for which no curative option exists. * eastern cooperative oncology group (ecog) performance status 0 to 2. * during the dose expansion part of the study patients must have measurable disease defined by at least 1 of the following 2 measurements: * serum m-protein ≥ 0.5 g/dl * urine m-protein ≥ 200 mg/24 hours * serum free light chain (flc) \> 100 mg/l of involved flc exclusion criteria: * patients who are currently receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least one week prior to the start of treatment with lgh447: * strong inhibitors or inducers of cyp3a4 * cyp3a4 substrates with narrow therapeutic index other protocol-defined inclusion/exclusion criteria may apply.

Keywords: myeloma multiple myeloma mm
pmcf investigation of medical device chitocare® medical

Conditions: Dermatitis; Acne; Conditions After Dematosurgical Procedures; Scars

Summary: this is a post-marketing observational clinical investigation conducted as part of the post-market clinical follow-up of chitocare® medical, aimed to confirm safety and efficacy according to the requirements of regulation (eu) 2017/745 of the european parliament and of the council of 5 april 2017 on medical devices, for the following indications: gel - scars, conditions after dermatosurgical procedures, dermatitis, acne spray - conditions after dermatosurgical procedures, dermatitis, acne


Eligibility criteria:
the inclusion criteria are fully according to indications: * gel - scars, conditions after dermatosurgical procedures, dermatitis, acne * spray - conditions after dermatosurgical procedures, dermatitis, acne the criteria for exclusion are fully according to contraindications: * allergy to any of the ingredients of the product
cognitive functioning in opioid use disorder

Conditions: Opioid Use; Cognitive Change; Opioid-use Disorder

Summary: this outpatient study is designed to examine the potential relationship between non-fatal opioid overdose and cognitive functioning. this study will also examine the impact of computerized working memory training on relevant outcomes (cognition, psychosocial functioning, quality of life, drug use). the training component of the study lasts 1 month, with follow up visits and 1-month and 3-months post training.

this outpatient study is designed to examine the potential relationship between non-fatal opioid overdose (i.e. overdose that does not result in death), cognitive functioning, and the impact of computerized working memory training on relevant outcomes (cognition, psychosocial functioning, quality of life). participants (n=30) with a history of at least one prior opioid od, who are enrolled in buprenorphine treatment, will be randomized to 20 sessions of an active (n=15) or sham (n=15) working memory training. patients will complete measures of cognitive functioning during screening, post-training, and at 1-month and 3-month follow up. participants will also complete the measures of decision making, psychosocial functioning and drug use at baseline, post-training, and follow up.

Eligibility criteria:
inclusion criteria: * meets dsm-5 criteria for moderate-severe opioid use disorder (oud) in the past 6 months * enrolled in a suboxone (buprenorphine/naloxone) program; willing to provide consent for research team to contact treatment provider * history of at least 1 prior opioid overdose * recent history of illicit opioid use * in good physical health * access to a smartphone, tablet, or computer exclusion criteria: * evidence of a co-occurring, untreated psychiatric condition that would make participation risky or difficulty * lack of access to a home computer, smartphone, or tablet * unable to speak, read and/or communicate in english
a pilot study of em-1421 for the treatment of cervical intraepithelial neoplasia

Conditions: Cervical Intraepithelial Neoplasia

Summary: the primary objective of this study is to determine pilot safety and efficacy data for a topical formulation of em-1421 applied to the cervix of patients with cin 1, 2, or 3.

this was an open-label, pilot phase i/ii dose evaluation and pharmacokinetic evaluation study to compare the safety and efficacy of terameprocol (45mg or 90mg/application)administered once per week for 3 weeks to the cervix uteri in patients with biopsy-proven cin. patients who met eligibility criteria visited the clinic weekly for terameprocol application. patients kept a daily diary card record of genitourinary symptoms.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * negative pregnancy test * biopsy confirmed cin 1, 2, or 3 exclusion criteria: * pregnancy or breast feeding

Keywords: cervical intraepithelial neoplasia cin hpv
a study to determine the efficacy and safety of deucravacitinib compared with placebo in participants with active psoriatic arthritis (psa) who are naïve to biologic disease modifying anti-rheumatic drugs or had previously received tnfα inhibitor treatment

Conditions: Psoriatic Arthritis

Summary: the purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active psa who are naïve to biologic disease modifying antirheumatic drugs or had previously received tnfα inhibitor treatment.the long term extension period will provide additional long-term safety and efficacy information.


Eligibility criteria:
inclusion criteria: * diagnosed to have psoriatic arthritis (psa) of at least 3 months duration at screening * meets the classification criteria for psoriatic arthritis (caspar) criteria at screening * active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (pso) at screening * active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at screening and day 1 * participant has high sensitivity c-reactive protein (hscrp) ≥ 3 mg/l at screening * must have completed the week 52 treatment for the optional open-label long-term extension period exclusion criteria: * nonplaque psoriasis at screening or day 1 * other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis * history of or current inflammatory joint disease other than psa (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, lyme disease) * active fibromyalgia * received an approved or investigational biologic therapy for the treatment of psa or pso other protocol-defined inclusion/exclusion criteria apply

Keywords: psoriatic arthritis psa deucravacitinib bms-986165 apremilast otezla