Kornimate/medical-research-clean huggingface dataset:
monitoring minimal residual disease（mrd）in pediatric b-acute lymphoblastic leukemia

Conditions: B Acute Lymphoblastic Leukemia

Summary: this study aimed to investigate the performance of next-generation sequencing (ngs) techniques measuring immunoglobulin heavy chain (igh)-variable, diversity, and joining (v\[d\]j) clonal rearrangements （igh-v\[d\]j ngs） compared with flow cytometry (fcm) in detecting of minimal residual disease (mrd) for children with acute lymphoblastic leukemia treated with south chinese children leukemia group (scclg)-all 2016, and to predict the relapse of the disease in the early stage and to assess the prognosis, so as to provide the basis for early intervention treatment and reduce the hematological relapse and improve the survival rate.

the measurement of residual leukemia levels, "minimal residual disease" (mrd), during therapy has now emerged as the most important predictor the outcome in acute lymphoblastic leukemia (all). as a result, risk-classifications based on mrd assessment has become an essential part of determining disease risk and directing therapeutic approach for children and adults with all. recently, next-generation sequencing (ngs) techniques measuring immunoglobulin (ig) or t-cell receptor (tcr) clonal rearrangements as a method of detecting mrd have been introduced. these approaches expand the sensitivity of mrd detection to as high as 1 in 10,000,000 cells and have been shown to be predictive of relapse in children with all receiving standard chemotherapy. in this study, the investigators will determine the sensitivity and specificity of igh-v(d)j ngs and compared its capacity to measure mrd with that of flow cytometry using diagnostic and follow-up samples from more than 100 patients with all. patients under age of 18 years with newly diagnosed all will be recruited and receive the treatment strategy of (scclg)-all 2016. after identifying a trackable clone in diagnostic samples (baseline), mrd was measured using igh-v(d)j ngs and fcm on bone marrow at 3 time-points: fifteen days after induction therapy (d15), thirty-three days after induction therapy (d33) and then at the end of induction therapy. event-free survival (efs), relapse-free survival (rfs) and overall survival (os) were assessed.

Eligibility criteria:
inclusion criteria: 1. age≤18 years. 2. newly diagnosed b-all. 3. no previous treatment. 4. signed informed consent in keeping with the policies of the hospital. exclusion criteria: 1. history of other malignancies, except in situ carcinoma or malignancy treated with curative intent. 2. patients with active or uncontrollable infections such as hepatitis b, hepatitis c or hiv infection. 3. patients with uncontrolled autoimmune diseases or immune defects. other protocol-defined inclusion/exclusion may apply.
a phase 3 trial of mm120 for generalized anxiety disorder (panorama)

Conditions: Generalized Anxiety Disorder

Summary: a phase 3, double-blind, placebo-controlled study (part a) with an open-label extension (part b) evaluating mm120 compared to placebo in generalized anxiety disorder - panorama

the study will enroll up to 375 participants aged 18 to 74 years, inclusive with a diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) confirmed primary diagnosis of gad and a minimum ham a total score of at least 20 at screening and baseline without clinically relevant medical or psychiatric history. the study consists of a 12-week randomized, double-blind, single-dose administration period evaluating mm120 versus placebo, followed by a 40-week extension phase with the opportunity for open-label treatment. during this phase, participants will be monitored and evaluated for potential treatment with mm120 based on pre-specified safety and symptom severity criteria.

Eligibility criteria:
inclusion criteria: 1. diagnosis of gad per dsm-5 2. male or female aged 18 to 74 3. ham-a total score ≥20 exclusion criteria: 1. certain psychiatric disorders (other than generalized anxiety disorder) 2. first degree relative with or lifetime history of a psychotic disorder or bipolar disorder 3. current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine) 4. any clinically significant unstable illness
safety and efficacy of 50 mg nyx-783 qd vs. placebo in ptsd

Conditions: PTSD

Summary: a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 50 mg nyx-783 once daily compared to placebo in participants with post-traumatic stress disorder (ptsd)


Eligibility criteria:
inclusion criteria: * ptsd (dsm-5 criteria) * stable allowed medications with no planned changes from 30 days prior to screening through study participation * willing to use highly effective birth control * willing to comply with protocol visits and procedures exclusion criteria: * moderate to severe traumatic brain injury * other psychiatric disorders (based on scid-5-ct) or neurodegenerative disorders * substance use disorder or alcohol use disorder within 6 months prior to screening * psychotherapy or cognitive based therapy within 30 days prior to screening * use of investigational drug within 30 days prior to screening * prior participation in study of nyx-783, nyx-2925 or nyx-458.
a single and multiple ascending dose study to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of azd2389 in healthy participants

Conditions: Healthy Participants

Summary: this study will assess the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of azd2389 following single and multiple dose administration (sad/mad) to healthy participants.

this is a phase i, first in human (fih), randomized, single-blind, placebo-controlled, single and multiple ascending dose study in healthy male and/or female participants of non-childbearing potential including healthy participants of chinese and japanese ethnicity performed at a single center. the study consists of 2 parts: part a and part b. part a has been planned to be conducted with 78 participants and part b has been planned to be conducted with 32 participants. each participant in part a and part b will be involved in the study for up to 8 weeks.

Eligibility criteria:
inclusion criteria: * healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture. * for the healthy japanese cohorts (parts a2 and b2): healthy participants are to be japanese (e.g., natives of japan or japanese americans), defined as having both parents and 4 grandparents who are japanese. this includes healthy second and third generation participants of japanese descent whose parents or grandparents are living in a country other than japan. * for the healthy chinese cohort (part a3): healthy participants are to be chinese defined as having both parents and 4 grandparents who are ethnically chinese. this includes second and third generation chinese whose parents or grandparents are living in a country other than china. exclusion criteria: * any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of imp. * known or suspected history of alcohol or drug abuse and smokers. * plasma donation within one month of the screening visit or any blood donation/blood loss \> 500 ml during the 3 months prior to the screening visit. * history of coagulation or bleeding disorders or use of anti-platelets/anti-coagulants during the 3 months prior to the screening visit, as judged by the investigator. * history of hypersensitivity as judged by the investigator, to drugs with a similar chemical structure or class. * history of severe dermatological disorders, eg, bullous pemphigoid or stevens-johnson syndrome, or clinically significant new or healing wounds in areas of the body not always covered by clothing such as face, forearm, and lower leg, as judged by the investigator.

Keywords: liver disease single ascending dose multiple ascending dose
alicaforsen (isis 2302) in patients with active crohn's disease

Conditions: Crohn's Disease

Summary: isis 2302 is an antisense oligonucleotide drug that reduces the production of a specific protein called intercellular adhesion molecule (icam-1), a substance that plays a significant role in the increase of inflammation. people with crohn's disease have been shown to over-produce icam-1 in their gut tissues. alicaforsen works by blocking icam-1 messenger rna, the "instruction" molecule that is required for the production of icam-1 protein. this trial will examine effects of alicaforsen delivered by 2-hour intravenous infusion over a four-week period, compared to a placebo. patients may remain on stable background 5-asa, antibiotic, or immunosuppressive drugs, and prednisone (or equivalent) at \</= 30 mg per day.


Eligibility criteria:
inclusion criteria 1. age \>/= 12 years 2. weight \>/= 36 kg 3. cdai score of 220 - 400 4. documentation of crohn's disease activity by endoscopy, biopsy or imaging in the last 2 years 5. no tnf-α inhibitor treatment for three months prior to first study drug infusion exclusion criteria 1. known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation 2. extensive external fistulization (\> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy 3. active infection, including infectious colitis, or infection with hiv, hepatitis b or hepatitis c 4. malignancy within 3 years or poorly controlled medical illness 5. requires intravenous heparin therapy or with a history of a bleeding problem
vascular endothelial growth factor vegf trap-eye:investigation of efficacy and safety in wet age-related macular degeneration(amd)

Conditions: Macular Degeneration

Summary: this study is a phase 3, double-masked, randomized, study of the efficacy and safety of vegf trap-eye in patients with neovascular age-related macular degeneration. approximately 1200 patients will be randomized in the us and canada.


Eligibility criteria:
inclusion criteria: 1. signed informed consent. 2. men and women ≥ 50 years of age. 3. active primary or recurrent subfoveal cnv lesions secondary to amd, including juxtafoveal lesions that affect the fovea as evidenced by fa in the study eye. 4. early treatment diabetic retinopathy study (etdrs) best corrected visual acuity (bcva) of: letter score of 73 to 25 (20/40 to 20/320) in the study eye at 4 meters. 5. willing, committed, and able to return for all clinic visits and complete all study-related procedures. 6. able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member. see appendix j.4) understand and willing to sign the informed consent form. key exclusion criteria: 1. any prior ocular (in the study eye) or systemic treatment or surgery for neovascular amd except dietary supplements or vitamins. 2. any prior or concomitant therapy with another investigational agent to treat neovascular amd in the study eye, except dietary supplements or vitamins. 3. any prior treatment with anti-vegf agents in the study eye. 4. total lesion size \> 12 disc areas (30.5 mm\^2, including blood, scars and neovascularization) as assessed by fa in the study eye. 5. subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (if the blood is under the fovea, then the fovea must be surrounded 270 degrees by visible cnv.) 6. scar or fibrosis, making up \> 50% of total lesion in the study eye. 7. scar, fibrosis, or atrophy involving the center of the fovea. 8. presence of retinal pigment epithelial tears or rips involving the macula in the study eye. 9. history of any vitreous hemorrhage within 4 weeks prior to visit 1 in the study eye. 10. presence of other causes of cnv in the study eye. 11. history or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina,other than amd, in either eye. 12. prior vitrectomy in the study eye. 13. history of retinal detachment or treatment or surgery for retinal detachment in the study eye. 14. any history of macular hole of stage 2 and above in the study eye. 15. any intraocular or periocular surgery within 3 months of day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as its unlikely to interfere with the injection.
tragal perichondrium versus pretragal fascial (smas) graft for endoscopic myringoplasty

Conditions: Tympanic Membrane Perforation

Summary: 1. examine the treatment outcomes of the pretragal (smas) fascia as a new graft when used in endoscopic myringoplasty. 2. compare the results when using the tragal pericondrium as a graft in endoscopic myringoplasty regarding donor site and success.

the exclusive transcanal endoscopic tympanoplasty technique emerged in the1990s : it provides a more direct and wider surgical viewing angle, largely reduces the necessity for a traumatic postauricular incision. some otolgists have adopted this technique using the nearby tragal perichondrium/cartilage graft. the tragus has a pivotal function in reconstruction in ear surgery. the superficial musculoaponeurotic system (smas) was first introduced by mits and peyroniein1976. it is located in the mid-face overlying the parotid gland and mimic muscles, it connects the dermis and the muscles, acting as a unique motor unit to produce facial expressions. the smas graft has great potential because it is accessible from the least invasive transcanal route of tympanoplasty, and is located away from the vital structures.

Eligibility criteria:
inclusion criteria: 1. above 16 yrs old and less than 50 yrs old. 2. clinically diagnosed central tympanic membrane perforations or chronic suppurative otitis media (tubo-tympanic). 3. dry ear: no otorrhea without medication for at least 1 month. 4. hearing loss gap not more than 50db exclusion criteria: 1. age less than 16 or more than 50. 2. discharging (active) central perforations. 3. unsafe csom with cholesteatoma. 4. suspected ossicular pathology in safe csom if the gap \> 50db. 5. previous ear surgery. 6. patients unfit for surgery or having chronic medical illness.
trail evaluating carbon ion radiotherapy (3 gye per fraction) for locally recurrent nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this study is to determine the maximal tolerated dose (mtd) of re-irradiation using carbon ion radiotherapy (cirt) with the fraction size of 3 gray equivalent (gye) in the treatment of locally recurrent nasopharyngeal cancer (npc) and to evaluate the efficacy of such treatment at the mtd. participants will be treated with cirt with escalating dose regimens to evaluate the mtd in terms of acute and subacute toxicity observed during and within 4 months after the completion of cirt. once the mtd for locally recurrent npc is determined, the mtd will be used as the recommended dose to patients fulfilling the inclusion criteria in the phase ii part of the trial.

the purpose of this study is to determine the maximal tolerated dose (mtd) of re-irradiation using carbon ion radiotherapy (cirt) with the fraction size of 3 gye in the treatment of locally recurrent nasopharyngeal cancer (npc) and to evaluate the efficacy of such treatment at the mtd. participants will be treated with cirt with escalating dose starting from 54gye (3gye/daily fraction) to potentially 63gye (3gye/daily fraction) to evaluate the maximal tolerated dose (mtd) in terms of acute and subacute toxicity observed during and within 4 months after the completion of cirt. the classic 3+3 method is used for the phase i dose escalating part of the trial and approximately 4-18 patients will be accrued. once the mtd for locally recurrent npc is determined, the mtd will be used as the recommended dose to patients fulfilling the inclusion criteria in the phase ii part of the trial. the phase ii part of the trial will be a single phase single arm study.

Eligibility criteria:
inclusion criteria: * completed a definitive course of intensity-modulated photon radiation therapy (imxt) to a total dose of ≥ 66 gy * recurrence diagnosed more than 12 months after the initial course of imxt * age ≥ 18 and \< 70 years of age * karnofsky performance score ≥70 * willing to accept adequate contraception for women with childbearing potential * ability to understand character and individual consequences of the clinical trial * willing to sign the written informed consent; informed consent must be signed before the enrollment in the trial exclusion criteria: * local recurrence of npc diagnosed within 12 months from the completion of previous course of radiation therapy * presence of distant metastasis * technology used other than imxt (including brachytherapy following imxt) for the treatment of initial diagnosis of npc * pregnant or lactating women * patients who have not yet recovered from acute toxicities of prior therapies * a diagnosis of malignancy other than carcinoma in situ of the cervix, basal cell carcinoma and squamous cell carcinoma of the skin within the past 5 years * refusal of the patient to participate into the study

Keywords: re-irradiation carbon ion therapy
outcome after arthroscopic surgery in patients treated with pao

Conditions: Developmental Dysplasia of the Hip

Summary: the purpose of the study is to evaluate outcome after arthroscopy if the hip in patients previous treated with periacetabular osteotomy

it is well known the patients with developmental dysplasia of the hip beyond the bony malformation has intraarticular damage to labrum and chondral structures. in dk, if the patients has persistent pain in the hip joint after pao, they have been offered a hip arthroscopy, however we do not if their hip functions and pain improved by the surgery the investigator aimed to make a short to middle-term followup study to see if the patients had benefits of the surgery.

Eligibility criteria:
inclusion criteria: * previous pao and hip arthroscopy * developmental dysplasia of the hip exclusion criteria: * calve legg perthes disease * femoral osteotomy
an evaluation of use of topical ocular hypotensive medication by compliance

Conditions: Glaucoma; Ocular Hypertension

Summary: this is an open-label study in patients who are currently using either a topical prostaglandin as sole ocular hypotensive medical therapy q.d., or a topical prostaglandin plus an adjunctive topical ocular hypotensive marketed product either q.d., or b.i.d. in the same eye(s). compliance will be measured over the two months of participation.

this is an open-label study in patients who are currently using either a topical prostaglandin as sole ocular hypotensive medical therapy q.d., or a topical prostaglandin plus an adjunctive topical ocular hypotensive marketed product either q.d., or b.i.d. in the same eye(s). compliance will be measured over the two months of participation.

Eligibility criteria:
inclusion criteria: * currently using one or two topical ocular hypotensive medications exclusion criteria: * hypersensitivity to any component of medication

Keywords: glaucoma compliance
esophageal squamous cell cancer surveillance with cytosponge

Conditions: Esophageal Cancer

Summary: surveillance and early detection of esophageal squamous cell carcinoma with minimally-invasive cytosponge™ cell collection device coupled with molecular biomarkers.

the goal of the study is to identify molecular abnormalities at each developmental stage of esophageal squamous cell carcinoma (low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and early squamous cell carcinoma) in order to establish new molecular biomarkers with potential for early detection and surveillance of the disease using the minimally-invasive cytosponge™ cell collection device. firstly, tissue samples after endoscopic treatment (endoscopic mucosal resection and endoscopic submucosal dissection) for squamous intraepithelial neoplasia and early squamous cell carcinoma will be analyzed with the use of the next-generation sequencing to identify potential diagnostic biomarkers. afterward, patients with- and at risk- of esophageal squamous cell carcinoma will be recruited to undergo a diagnostic endoscopy with biopsies (the gold standard) and cytosponge procedure. the diagnostic accuracy of cytosponge coupled with molecular biomarkers will be evaluated to compare with the gold standard.

Eligibility criteria:
inclusion criteria: patients with esophageal squamous cell cancer (escc): * patients ≥18 years of with adequate performance status for endoscopy * newly diagnosed escc suitable for endoscopic or oncological treatment (rth/chth) * patients currently undergoing oncological treatment (rth/chth) * consent to provide tissue samples for the study * dysphagia grade ≤2 (able to swallow mixed foods and tablets) patients at high risk for escc: * patients ≥18 years of age with adequate performance status for endoscopy * prior definitive treatment for head and neck cancer (cancer of the oral cavity, hypopharyngeal cancer, laryngeal carcinoma) and at least 12 months post-therapy (both rth, chth, and combination treatment) * prior definitive endoscopic treatment for early escc in the past (at least 6 months since completion) * consent to provide tissue samples for the study * dysphagia grade ≤2 exclusion criteria (for both groups of patients): * patients currently on anticoagulant treatment (warfarin, acenocoumarol) with no possibility of stopping / modification * dysphagia grade ≥3 (able to swallow only liquid foods) * history of myocardial infarction or other cardiovascular event within 6 months of enrolment * neurological diseases associated with impaired swallowing * patients in long-term care or institutional care (physical, psycho-social disorders, intellectual disability).