Kornimate/medical-research-clean huggingface dataset:
tonsillotomy or follow-up in pfapa syndrome

Conditions: PFAPA Syndrome

Summary: children with periodic fever, aphthous stomatitis, pharyngitis, adenitis (pfapa) -syndrome diagnosis will be randomised either to tonsillotomy (partial tonsillectomy) or 3 months follow up. at follow up visit 3 months after randomisation the children from either groups with ongoing symptoms will be sent to tonsillectomy.

children with periodic fever, aphthous stomatitis, pharyngitis, adenitis (pfapa) -syndrome diagnosis will be randomised either to tonsillotomy (partial tonsillectomy) or 3 months follow up. in both groups the symptoms are monitored with symptom diaries. at follow up visit 3 months after randomisation the children from either groups with ongoing symptoms will be sent to tonsillectomy (total remove of palatine tonsil). the design is sequential trial. from the previous trials we know that the effect of tonsillectomy is about 90% and that during follow up for six months as much as 50% of the patients will recover. because the syndrome is rare and because the rescue operations of the tonsils (tonsillectomy in a person who has gone through tonsillotomy), the sample size has to be as low as possible. that is the reason why we chose sequential design, with assessments after every 8 patient. randomization is made in blocks of four. in sequential design we use the following assumptions: * we are looking for a 40% absolute difference in cure rate between tonsillotomy (90%) and follow up (50%) groups. * two sided whitehead design * maximum likelihood estimation (mle) * five assessments (sample size 4+4, 8+8. 12+12, 16+16 and 19+19) * type 1 error 5 % and power 80% * the sample size will be from 8 to 38 patients depending on when the trial can be stopped along assessments.

Eligibility criteria:
inclusion criteria: * diagnosed pfapa syndrome: regularly occurring fever episodes for 3-5 days for at least five times or for 6 months exclusion criteria: * prior tonsil surgery
study comparing sbs and lrti for treatment of cmc arthritis

Conditions: Arthritis

Summary: a multi-center, randomized control trial comparing the two standard of care surgical treatments for cmc arthritis ; trapezial excision with or without soft tissue interposition and /or ligament reconstruction (lrti) versus the suture button suspension arthroplasty (sbs). patient reported outcomes will be collected at 6 and 6 weeks, 3, 6, and 12 months.

lrti is a well established treatment of cmc arthritis with good results.however, comparable results have also been reported with sbs, with the latter procedure eliminating the need for flexor carpi radialis (fcr) harvest and interposition, resulting in potential shorter or time and donor site morbidity. to date, there have been biomechanical studies comparing lrti vs suture button suspension arthroplasty (sbs), and clinical studies comparing trapeziectomy alone vs sbs, but to the best of our knowledge, no random control studies comparing lrti with sbs.the primary objective is to determine whether treatment with sbs results in improved overall pain relief compared to lrti as measured by patient reported outcomes.secondary outcome measures will be to determine if sbs results in shorter or time and improved grip and pinch strength compared to lrti, as well as have comparable return to work times and amount of radiographic shortening as shown on radiographs (metacarpal shortening has been felt to lead to decreased grip strength).

Eligibility criteria:
inclusion criteria: * age fifty years or older * isolated carpometacarpal (trapeziometacarpal) osteoarthritis * failure to respond to non-operative management * willing and able to consent on their own behalf and follow the protocol and clinical visits as described * able to read and understand english or have interpreter available exclusion criteria: * previous surgery for cmc arthritis * duration of symptoms for less than 6 months * greater than or equal to 30 degrees of ipsilateral metacarpophalangeal (mcp) hyperextension * scaphotrapeziotrapezoidal (stage 4 cmc) arthritis * other significant ipsilateral wrist or hand pathology * a history of inflammatory arthropathy * a requirement for concomitant surgery for another condition * any previous hand or wrist fracture * likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged patients without adequate support, etc.)
septic pseudarthrosis of long bone : experience in a regional reference center

Conditions: Pseudoarthrosis of Bone

Summary: description of septic pseudarthrosis with chirurgical treatment in two steps (first step : implementation of cement, second step : bone reconstruction, with or without device)


Eligibility criteria:
inclusion criteria: * patients having septic pseudarthrosis of long bone treated at the crioac lyon exclusion criteria: -
effects of a face mask on oxygenation during exercise

Conditions: Hypoxemia

Summary: there is concern that wearing a face mask during covid will affect oxygen uptake, especially during intense exercise. this study will assess the effect of wearing two different face masks (disposable and cloth) on blood and muscle oxygenation during cycling exercise.

there is concern that wearing a face mask during exercise will reduce oxygen uptake or increase carbon dioxide re-breathing, which can result in low blood oxygen levels, reduced oxygen delivery to muscle and reduced exercise capacity. the purpose of the study is to determine the effect of wearing two different types of commonly-worn face masks (diposable and cloth) during exercise on blood and muscle oxygenation. twelve participants who are experienced with cycling will take part in this randomized cross-over study that will assess blood oxygenation (i.e. pulse oximetry) and muscle oxygenation (with near infrared spectroscopy) during a progressive step exercise test to exhaustion. the conditions include no mask, a disposable mask, and a cloth mask. outcome variables include exercise duration, rating of perceived exertion, blood oxygen saturation levels, and oxygenated, deoxygenated, and total hemoglobin at the quadriceps muscle.

Eligibility criteria:
inclusion criteria: * experienced with cycling exclusion criteria: * contra-indications to exercise as identified by a screening questionnaire (the "get active questionnaire")
research study in patients with severe ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy. the research is being conducted at up to 8 clinical research sites in the us and is open to both men and women ages 18 to 70 years old. participants in the study will have a number of visits to a research site. all study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.

a phase i, dose-escalation, pilot study designed to obtain safety and tolerability data on visilizumab administered to patients with severe ulcerative colitis that has failed to respond to steroid therapy. patients who are currently receiving iv corticosteroids, but whose disease has not responded after at least 5 days of this therapy, will be eligible for the study.

Eligibility criteria:
1. a diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry. 2. active disease despite ongoing treatment with steroids

Keywords: colitis gastrointestinal disease digestive system disease intestinal disease colonic disease
a study of lam-003 in patients with acute myeloid leukemia

Conditions: Oncology; Acute Myeloid Leukemia

Summary: a phase 1 dose-escalation study of lam-003 in patients with acute myeloid leukemia

this clinical trial is a phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of lam-003 across a range of lam-003 dose levels when administered to subjects with previously treated relapsed or refractory cute myeloid leukemia (aml). subjects will self-administer oral lam-003 either once or twice per day as long as they are safely benefitting from therapy. cohorts of 3 to 6 subjects will be sequentially enrolled at progressively higher dose levels of lam-003 using a standard 3+3 dose-escalation design. based on the pattern of dose-limiting toxicities observed in the first 4 weeks of therapy, escalation will proceed to define a recommended lam-003 dosing regimen.

Eligibility criteria:
inclusion criteria: 1. men and women of age ≥18 years. 2. eastern cooperative oncology group (ecog) performance status of 0, 1, or 2. 3. presence of measurable aml that has progressed during or relapsed after prior therapy 4. all acute toxic effects of any prior antitumor therapy resolved to grade 1. 5. adequate hepatic profile. 6. adequate renal function. 7. adequate coagulation profile. 8. negative antiviral serology for human immunodeficiency virus (hiv), hepatitis b, and hepatitis c. 9. for female subjects of childbearing potential, a negative serum pregnancy test. 10. for both male and female subjects, willingness to use adequate contraception. 11. willingness and ability of the subject to comply with study activities. 12. evidence of a personally signed informed consent document. exclusion criteria: 1. leukemic blast cell count \>50 × 10\^9/l before the start of study therapy and despite the use hydroxyurea, cytarabine, and/or cyclophosphamide. 2. presence of known central nervous system (cns) leukemia. 3. presence of another major cancer. 4. ongoing grade \>1 proliferative or nonproliferative retinopathy. 5. significant cardiovascular disease or ecg abnormalities. 6. significant gastrointestinal disease 7. uncontrolled ongoing infection. 8. pregnancy or breastfeeding. 9. major surgery within 4 weeks before the start of study therapy. 10. subject was a candidate for hematopoietic stem cell transplantation (hsct). 11. ongoing severe graft-versus-house disease (gvhd) with grade ≥2 serum bilirubin, grade ≥3 skin involvement, or grade ≥3 diarrhea at the start of study therapy. 12. prior solid organ transplantation. 13. ongoing immunosuppressive therapy other than corticosteroids. 14. use of a strong inhibitor or inducer of cytochrome p450 (cyp) 3a4. 15. use of a drug known to prolong the cardiac qt interval. 16. concurrent participation in another therapeutic or imaging clinical trial. 17. presence of a concomitant medical condition that (in the judgement of the investigator) interferes with the ability of the subject to participate in the study.
music workshops in the empower clinic

Conditions: Sex Trafficking; Sexual Violence; Trauma

Summary: women will be recruited from the empower clinic when they present for care; they may be given a flyer as part of their clinic entry paperwork, or approached by a study staff member in the waiting area of the clinic. women who are clients of sanctuary for families may find out about the music workshops and the study through sanctuary for families staff, who will post flyers in their noticeboards or offices. this study will use a repeated measures survey design to evaluate the effect of a musical workshop intervention to aid in the management of mood, anxiety, and stress among women enrolled in the empower clinic for survivors of sex trafficking and sexual violence. assessment of the feasibility and acceptability of this music intervention will be carried out on participants as they are taught to manage stress and emotions.


Eligibility criteria:
inclusion criteria: * women enrolled in the empower clinic and/or sanctuary for families exclusion criteria: * unwilling or unable to participate or provide informed consent.

Keywords: post traumatic stress disorder (ptsd)
the clinical trial protocol for the inactivated poliomyelitis vaccine made from sabin strains (ipv)

Conditions: Poliomyelitis

Summary: based on pre-clinical trial and phase 1 clinical data and principle of gcp, the objective of phase ⅱ clinical trial is to evaluate safety and immunogenicity of inactivated poliomyelitis vaccine made from sabin strains(sabin ipv).

the sabin ipv was manufactured with poliovirus type1, 2, 3 sabin strains and vero cells by microcarrier culture in 550 liter bioreactors. the virus suspension was harvested ,ultra-concentrated, purified and inactivated with formalin. three formulations a,b,c of sabin ipv were used, the dag contents for a were type1 45,type2 64,type3 67.5 du /0.5ml/per dose; for b 30,32,45 du/0.5ml/per dose; for c 15,16,22.5 du/0.5ml/per dose. oral poliomyelitis vaccine(opv)was manufactured by institute of medical biology, chinese academy of medical sciences.trivalent opv contains polioviruses type 1 6.0 log ccid type 2 5.0 log type 3 5.5log /0.1ml/per dose inactivated poliomyelitis vaccine (salk strains)was manufactured by sanofi pasteur dag contents /0.5ml/per dose were type 1 40 du,type 2 8du,type 3 32du. this is a randomized, blind phase 2 clinical trial. total 500 infants (ages 60 days to 90 days) were selected , randomized to five groups(each group n=100) sabin ipv formulations a,b,c,opv ,salk ipv were separately given to each group with three doses one month apart respectively.

Eligibility criteria:
inclusion criteria: * males and females, age from 60 days to 90 days; * adults, parent(s) or guardians are able to understand and sign informed consent for participation; * participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions; * infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days; * axillary temperature ≤37℃. exclusion criteria: * have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy; * low platelet or bleeding disorder do not allow vaccination into the muscle; * have damaged or lower immunological function; * received blood, plasma or immunoglobulin treatment since birth; * have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( down syndrome, diabetes, sickle cell anemia or neural guillain-barre syndrome ); * have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, hiv. exclusion criteria for doses 2 and 3 * have serious anaphylaxis or high fever, convulsion during first dose; * have any circus of exclusion criteria after eligible for study; * have serious adverse event which related to previous vaccination; withdrawal and discontinuance criteria; * received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents; * vaccinated with any other vaccine（except dtp）; * stop observation determined by investigator owing to occurring serious adverse event;

Keywords: inactivated poliomyelitis vaccine sabin strains poliomyelitis
dutasteride 0.5mg for the treatment of chinese patients with benign prostatic hyperplasia (bph)

Conditions: Benign Prostatic Hyperplasia; Prostatic Hyperplasia

Summary: this randomized, double-blind, placebo-controlled, six-month parallel-group study assess efficacy and safety of dutasteride 0.5mg once daily in chinese patients with benign prostatic hyperplasia (bph) , followed by a 12-month open-label treatment phase


Eligibility criteria:
inclusion: * clinical diagnosis of bph * aua-si \>=12 \[american urological association symptom index\] * qmax \> 5ml/sec and \ =125ml * prostate volume \>=30cm(3) exclusion: * post void residual volume \>250ml * history or evidence of prostate cancer * total serum psa \ 10.0ng/ml (prostate specific antigen) * previous prostatic surgery or other invasive procedures to treat bph. * history of aur (acute urinary retention) within 3 months * history of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days * any causes other than bph, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate * history of hepatic impairment or abnormal liver function tests * use of any 5a-reductase inhibitors ,any drugs with antiandrogenic properties or other drugs noted for gynaecomastia effects, or could affect prostate volume, within past 6 months and throughout the study * use of alpha-receptor blockers within 2 weeks and throughout the study. * use of phytotherapy for bph within 2 weeks and/or predicted to need phytotherapy during the study. * concurrent use of anabolic steroids * use of any alpha-adrenergic agonists or cholinergics within 48 hours prior to uroflowmetry assessment. * hypersensitivity to any 5a-reductase inhibitor or other chemically-related drugs. * actively trying to procreate or unwilling to wear a condom during intercourse with a woman of childbearing potential for duration of participation in this study and 16 weeks following treatment. * history or current evidence of drug or alcohol abuse within the previous 12 months. * history of any illness that in the opinion of the investigator might confound the results of the study or poses additional risk to the patient. * any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, of cerebrovascular accident within 6 months prior to screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management. * history of renal insufficiency, or serum creatinine \>1.5xuln (upper limit of normal ) * participation in any investigational or marketed drug trial within 30 days and during the course of the study.

Keywords: placebo control chinese dutasteride randomized benign prostatic hyperplasia double blind
timing of hcg administration in iui cycles

Conditions: Infertility

Summary: evaluation of the effect of altering the timing of human chorionic gonadotropin (hcg) administration on the clinical pregnancy rate in intrauterine insemination (iui) cycles.

women will be randomly divided into 3 groups; the first group will undergo iui at the time hcg administration, the second group will undergo iui 12 hours after hcg administration and the third group will undergo iui 34-36 hours after hcg administration.

Eligibility criteria:
inclusion criteria: * mild male factor infertility or unexplained infertility. exclusion criteria: * advanced male factor infertility. * polycystic ovary syndrome (pcos) as defined by the rotterdam criteria. * endometriosis. * tubal disease. * uterine abnormalities or myoma. * previous uterine surgery. * metabolic or hormonal abnormalities.

Keywords: intrauterine insemination iui hcg
cerebral venous thrombosis cohort study in china mainland

Conditions: Cerebral Venous Sinus Thrombosis; Deep Cerebral Vein Thrombosis; Cortical Vein Thrombosis

Summary: this study was aimed to reveal the clinical features,natural history of the diseases and current therapeutic situations of cerebral venous thrombosis (cvt) in china mainland. blood samples and cerebrospinal fluid samples will be collected after recruitment to reveal the pathological mechanisms of cvt and identify the biomarkers for cvt.

cerebral venous thrombosis (cvt) is caused by a clot in the cerebral vein, which resulted in an obstruction of the blood outflow. cvt mainly includes cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis. however, the epidemiological features of cvt in china mainland remained obscure. this study was aimed to establish a multicenter cohort recruiting patients with cvt across 31 provinces and municipalities in china mainland. clinical features,natural history of the diseases and current therapeutic situations will be analyzed to reveal the epidemiological features of cvt. blood samples and cerebrospinal fluid samples will be collected after recruitment to reveal the pathological mechanisms of cvt and identify the biomarkers for cvt. patients will be followed-up at 1, 3, 6, 12 months from baseline to evaluate the clinical prognosis and therapeutic outcomes.

Eligibility criteria:
inclusion criteria: • cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis diagnosed by digital subtraction angiography (dsa), magnetic resonance venography (mrv), computed tomography venography (ctv) or high-resolution magnetic resonance imaging (hr-mri). exclusion criteria: • none of the patient, trustee or immediate family members signed the informed consent.

Keywords: cerebral venous sinus thrombosis deep cerebral vein thrombosis cortical vein thrombosis cohort study real world evidence observational study china mainland cerebral venous system thrombosis
clinical decision support for blood transfusions to improve guideline adherence

Conditions: Anemia; Thrombocytopenia; Coagulopathy, Mild; Hypofibrinogenemia

Summary: determine whether clinical decision support (best practice advisory) improves provider adherence to transfusion guidelines for all four major blood components (red blood cells, plasma, platelets, and cryoprecipitate) using a randomized study design to reduce risk of bias. alerts will be visible to the experimental ordering provider group, while they will not be visible to the control. both groups still have access to information about best practices: local clinical transfusion guidelines are available and education on blood transfusion best practices will continue regardless of randomization assignment.


Eligibility criteria:
inclusion criteria: - ordering providers that order at least one blood product in the electronic health record exclusion criteria: * any individual without privileges to place an initial order for blood product(s)

Keywords: transfusion clinical decision support
identification and treatment of renal stenosis in transplanted kidneys

Conditions: Renal Artery Stenosis

Summary: renal artery stenosis is a complication that may follow kidney transplantation1-5. renal artery stenosis greater than 50% of the lumen of the artery, associated with clinical symptoms or laboratory worsening of renal function, may lead to transplant failure, however, the indications for treatment and the modalities of treatment remain, to date, a debated topic in the literature. the guidelines of the european society of urology recommend endovascular treatment as the first-line treatment by means of angioplasty and/or stent placement6. a recent review of the literature7 examined the results of 56 studies: the results fully support endovascular treatment of the disease which appears to be effective and with a low rate of complications.

the primary objectives of the study are to evaluate the efficacy (in terms of technical success and graft salvage) and safety (in terms of complications) of endovascular treatment using stenting in patients with renal artery stenosis following kidney transplantation. patients undergoing endovascular treatment of renal stenosis following kidney transplantation at the vascular surgery unit from january 2020 to april 2023 (retrospective phase) and from may 2023 up to 2 years from the start of the study.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * indication of renal transplant and diagnosis of renal artery stenosis of the transplant * obtaining informed consent exclusion criteria: -