Kornimate/medical-research-clean huggingface dataset:
immediate versus optional delayed surgical repair for treatment of acute acl injuries

Conditions: ACL Injury

Summary: currently, most patients with an anterior cruciate ligament injury undergo surgery. there is a general belief that surgical reconstruction is necessary to safely return to sports and to prevent early knee osteoarthritis or additional meniscus injuries. but there is insufficient scientific evidence to support this belief. moreover, several studies show that surgical reconstruction of the cruciate ligament does not guarantee successful return to sports or the prevention of osteoarthritis and secondary meniscus injuries. therefore, immediate surgery after an anterior cruciate ligament injury is questioned. so far, only two rcts (kanon study and compare study) have assessed this, and they could not show that immediate reconstruction is an added value (in terms of symptoms, knee function, activity level, osteoarthritis or additional meniscal injuries) compared to a conservative approach consisting of rehabilitation and late surgery for persistent knee instability. therefore, this additional multicenter rct, aims to 1) verify these results and 2) to identify predictors that predict which patients in the conservative group will not require late surgery. this has not been investigated to date. it is suspected that factors such as symptoms, strength, findings on the mri scan and psychological factors may play a role in whether or not a patient will be able to successfully rehabilitate without surgical repair. this information is invaluable to physicians because it allows them to decide which treatment is best for the patient.


Eligibility criteria:
inclusion criteria: * rotational trauma to a knee that had no previous serious injury and for which medical advice was sought within 4 weeks after the injury. * medical diagnosis of acl insufficiency including mri (both partial and complete ruptures) * minimum of 16 years exclusion criteria: * participant has a history of a previous acl injury or knee surgery to the index knee * indication for acute surgery because of related injuries to the knee * female who is pregnant or plans to become pregnant in the first 4 months of the trial. since mri assessment cannot be performed.

Keywords: acl rct conservative treatment acl reconstruction
a study to assess the safety and efficacy of inclacumab in participants with sickle cell disease experiencing vaso-occlusive crises

Conditions: Sickle Cell Disease; Vaso-occlusive Pain Episode in Sickle Cell Disease; Vaso-occlusive Crisis

Summary: this phase 3 study will assess the safety and efficacy of inclacumab, a p-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (vocs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (scd). participants will be randomized to receive inclacumab or placebo.

eligible participants will be administered inclacumab or placebo intravenous (iv) every 12 weeks. the total duration of treatment for each participant will be 48 weeks. participants that complete the study through week 48 will be provided the opportunity to enroll in an open-label extension (ole) study.

Eligibility criteria:
inclusion criteria: 1. participant has a confirmed diagnosis of scd (hbss, hbsc, hbsb0 thalassemia, or hbsb+ thalassemia genotype). documentation of scd genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing during screening. 2. participant is male or female, ≥ 12 years of age at the time of informed consent. 3. participant has experienced between 2 and 10 vocs within the 12 months prior to the screening visit as determined by documented medical history. a prior voc is defined as an acute episode of pain which: * has no medically determined cause other than a vaso-occlusive event, and * results in a visit to a medical facility (hospital, emergency department, urgent care center, outpatient clinic, or infusion center) or results in a remote contact with a healthcare provider; and * requires parenteral narcotic agents, parenteral nonsteroidal anti- inflammatory drugs (nsaids), or an increase in treatment with oral narcotics. 4. participants receiving erythropoiesis-stimulating agents (esa, e.g., erythropoietin \[epo\]) must be on a stable dose for at least 90 days prior to the screening visit and expected to continue with the stabilized regimen throughout the course of the study. 5. participants receiving hydroxyurea (hu), l-glutamine, or voxelotor (oxbryta®) must be on a stable dose for at least 30 days prior to the screening visit and expected to continue with the stabilized regimen throughout the course of the study. exclusion criteria: 1. participant is receiving regularly scheduled red blood cell (rbc) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion). 2. participant is taking or has received crizanlizumab (adakveo®) within 90 days prior to the screening visit 3. participant weighs \> 133 kg (292 lbs.). other protocol-defined inclusion/exclusion may apply.

Keywords: blood disorders hemoglobin red blood cells sickle-like shape mutation in hemoglobin gene sickle-cell trait sickle-cell crisis sickle cell disease scd vaso-occlusive crises voc sca rbcs
cmv-tcr-t cells for cm virus infection after hsct

Conditions: CMV Infection or Reactivation After Allogenic HSCT

Summary: this is a single cente, single arm, open-label, phase i study to evaluate the safety and effectiveness of cmv-tcr-t cell immunotherapy in treating cmv virus infection after hsct.

cmv infection is a common virus infection of hsct, and which is highly related with the failure of transplantation and survival time of transplant patients. to evaluate the safety and efficacy of allogenic cmv-tcr-t cell therapy in subjects with cmv infection, patients with cmv emias or deseases will be enrolled, and donor derived cmv-tcr-t(hla-a\*1101\\0201\\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 cmv-tcr-t cells. the cmv dna copies and cmv-tcr-t cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28).

Eligibility criteria:
inclusion criteria: 1. age 1-70 years, including boundary values, gender unlimited; 2. allogenic hematopoietic stem cell transplantation patients with cmv infection disease or persistent cmv emia; 3. at least one of the following conditions after allogeneic hsct: * after trested with 2-week standard antiviral drug, compared to the baseline of treatment, the decrease of cmv dna copies number was less than 1log10, and the cmv dna copies number is greater than 1000 copies/ ml ; * unable to tolerate the toxic and side effects of antiviral drugs,such as bone marrow hematopoietic suppression, nephrotoxicity; 4. estimated life expectancy ≥3 months； 5. ecog 3; 6. patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures. exclusion criteria: 1. patients with active agvhd iii-iv and / or mild and severe cgvhd; 2. received cell therapy such as dli,ctl,car-t or participated in any other clinical study of drugs and medical devices before 30 days of enrollment. 3. pregnant or lactating women; 4. intracranial hypertension or confusion; respiratory failure; disseminated intravascular coagulation; 5. patients with organ failure: * heart: nyha heart function grade iv; * liver: grade c that achieves child-turcotte liver function grading; * kidney: kidney failure and uremia; * lung: symptoms of respiratory failure; * brain: a person with a disability; 6. the researchers found that it was unsuitable for the recipients to be enrolled.
vaccination status, knowledge and attitude in korean patients with ibd

Conditions: Inflammatory Bowel Disease

Summary: the purpose of this study is to investigate the vaccination status, knowledge about vaccination, and attitude to vaccination of the korean patients with inflammatory bowel diseases

using structured questionnaires, the vaccination status, knowledge about vaccination, and attitude to vaccination of the korean patients with inflammatory bowel diseases will be investigated. the descriptive analyses will be performed and the factors influencing the vaccination status, knowledge, and attitude will be investigated.

Eligibility criteria:
inclusion criteria: * crohn's disease or ulcerative colitis * patients who are visiting asan medical center for the first time for the management of inflammatory bowel diseases * patients who give consent for participating in the study exclusion criteria: * patients who refuse to participate in the study
a feasibility trial for circadian rest-activity rhythm disorders in cancer (rali)

Conditions: Circadian Rhythm Disorders; Cancer

Summary: circadian rest-activity rhythm disorders are common in patients with cancer, particularly in advanced disease. a recent international e-delphi study has outlined recommendations for the assessment and reporting of the disorder and subsequently an observation study is underway assessing a cohort of patients with advanced cancer. affected patients are eligible to enter a feasibility study assessing a non-pharmacological multi-modal intervention.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old 2. outpatient 3. diagnosis of advanced cancer (locally advanced, incurable, metastatic) 4. ambulatory 5. estimated prognosis ≥ 3 months 6. evidence of a circadian rest-activity rhythm disorder exclusion criteria: 1. inpatient 2. engaged in shift-work 3. long-haul travel in the last 14 days 4. physical impairment limiting movement of the non-dominant arm 5. cognitive impairment limiting the ability to complete the assessment tool and/or patient diary 6. uncontrolled high blood pressure or tachycardia 7. exercise-related symptoms and signs (e.g. chest pain, syncope, limb claudication, hypoxia at rest) 8. participant has a history of uncontrolled mania or bipolar disorder 9. participant has a recent history or current thoughts of self-harm or suicide 10. participant has a recent change in antidepressant medication 11. participant has an eye disorder (e.g. glaucoma, cataracts, retinopathy)

Keywords: circadian rest-activity rhythms advanced cancer feasibility trial multi-modal
penehyclidine for ponv prophylaxis after strabismus surgery

Conditions: PONV

Summary: patients scheduled for elective strabismus surgery under general anesthesia in the first affiliated hospital of nanjing medical university will be included in this study. patients 1)asa i or ii, 2)aged 3-65 years, 3)scheduled for elective strabismus surgery under general anesthesia, will be included in the study. patients 1)had prior ponv, 2)severe motion sickness, 3)a history of ophthalmic surgery, 4)had received drugs known to have antiemetic effects, will be excluded from the study. the primary aim is to evaluate the prophylaxis effect of penehyclidine(a novel long acting selective anticholinergic agent developed in china) on postoperative nausea and vomiting after strabismus surgery. secondary outcomes include the effect of ponv risk factors and surgical technique on ponv rank score, occurance of oculocardiac reflex, time to extubation.


Eligibility criteria:
inclusion criteria: * asa i or ii * aged 3-65 years * scheduled for elective strabismus surgery under general anesthesia exclusion criteria: * had prior ponv * severe motion sickness * a history of ophthalmic surgery * had received drugs known to have antiemetic effects in 24h before surgery

Keywords: penehyclidine ponv
pathophysiological mechanisms of hypertensive lvh:optimising regression

Conditions: Hypertension; Left Ventricular Hypertrophy

Summary: uncontrolled high blood pressure can cause heart muscle 'thickening', and this increases the likelihood of complications and death. the high blood pressure explains some but not all of this increase in heart size. this study will investigate the other causes, and will measure the heart muscle 'thickness' very accurately using the latest and most accurate technique called cardiac magnetic resonance imaging (mri). the best way to treat this heart thickening remains to be determined. we hope to be able to show that by specifically targeting the cause of heart muscle thickening we can reduce its occurrence more effectively than by other standard means of blood pressure treatment


Eligibility criteria:
inclusion criteria: * recently diagnosed essential hypertension (within 6 months). * age 25 to 80 years; weight \< 100kg. * sinus rhythm without significant ventricular or atrial ectopy. exclusion criteria: * current angiotensin ii receptor antagonist or ace inhibitor treatment. * contra-indication to any of the protocol anti-hypertensive agents. * angina requiring treatment with a beta blocker or calcium antagonist * any disease affecting the autonomic nervous system e.g. congestive cardiac failure, diabetes, neurological disease, malignancy, pregnancy. * contraindication to mri (pacemaker, intra-orbital debris, intra-auricular implants, intra-cranial clips, history of claustrophobia, inability to lie supine for 15 minutes etc).

Keywords: hypertension left ventricular hypertrophy
glycyrrhetinic acid-effect on serum potassium and insulin resistance in dialysis patients

Conditions: End Stage Renal Disease

Summary: background: 18b glycyrrhetinic acid (active compound of licorice) decreases serum potassium via enhanced renal potassium loss in healthy individuals and thereby inducing renal sodium retention and arterial hypertension.in dialysis patients this mechanism is disturbed and compensatory intestinal potassium secretion is enhanced. 18b glycyrrhetinic acid is an inhibitor of 11b hydroxysteroid dehydrogenase type 1 (11b hsd1). inhibition of 11 b hsd1 offers a novel potential therapy to lower intracellular cortisol concentrations and thereby enhance insulin sensitivity. hypothesis: glycyrrhetinic acid decreases serum potassium by enhanced intestinal excretion in dialysis patients and increases insulin sensivity by inhibition of 11b hsd methods: double blind, 6 month cross over trial comparing oral 18b glycyrrhetinic acid with placebo in 24 nondiabetic dialysis patients. endpoints: predialytic serum potassium levels, insuline sensitivity assessed by fasting glucose and fasting insulin concentrations


Eligibility criteria:
inclusion criteria: * dialysis patients (\>3 months) exclusion criteria: * diabetics * hospital stay in the last 4 weeks

Keywords: dialysis serum potassium 18b glycyrrhetinic acid insulin sensitivity
person-centred interactive self-management support in primary healthcare for people with type 2 diabetes

Conditions: Diabetes Type 2

Summary: the aim of this study is to develop and evaluate a person-centred digital intervention in primary healthcare for people with t2d, in addition to their usual diabetes care.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes within the last five years * 18 years of age or older * ability to read and communicate in swedish * own a smart phone exclusion criteria: * 81 years and over at inclusion * life-threatening physical illness (e.g. cancer) * documented cognitive impairment * those not responsible for their own self care * those not residing in their own home environment (e.g. those in nursing homes, in-patient hospital wards)

Keywords: self-management primary health care ehealth
does antenatal fetal head circumference predict anal sphincter injury, a prospective study

Conditions: Anorectal Sphincter Laceration; Pelvic Floor Dysfunction

Summary: the purpose of this study is to see if fetal head circumference can be used as a predictor for who will experience a sphincter laceration while delivering.

even though much work has been invested in trying to identify risk factors that can predict which population will suffer from sphincter tears and other pelvic floor trauma, the epidemiology is still poorly understood. factors that have been implicated to include operative vaginal delivery, birth weight, and primaparity. up to this point little focus has been placed on antenatal factors that would help predict and prevent sphincter disruptions. at the time of birth the infant's head is the largest part of the body. thus, head circumference of the infant may be able to predict which subjects is more likely to suffer from sphincter disruption. thus, this study aims to determine whether or not fetal head circumference measured antenatally is predictive of pelvic floor trauma.

Eligibility criteria:
inclusion criteria: * primiparous subjects at least 18 years of age * gestational age greater than or equal to 36 weeks and upto 42 weeks gestation * subjects must have give written informed consent to participate in this study * subjects must be planning to deliver at uci exclusion criteria: * subjects less than 18 years of age * subjects with a previous delivery * subjects with previous colorectal surgery or hemorrhoidal surgery * subjects with a history of irritable bowel syndrome, ulcerative colitis, or crohn's disease * subjects with a history of colon or rectal cancer * gestational age less than 36 weeks * cesarean section

Keywords: anorectal sphincter laceration pelvic floor dysfunction sphincter tear
improve stroke care- developing and optimizing regional systems of stroke care

Conditions: Acute Stroke; Intracranial Hemorrhages; Subarachnoid Hemorrhage

Summary: the purpose of this program is to develop a regional integrated stroke system that identifies, classifies, and treats patients with acute ischemic stroke more rapidly and effectively with reperfusion therapy.

the design is based upon the implementation of best practice, that is, based on a comprehensive review of aha guidelines regarding treatment of acute stroke, ich (intracranial hemorrhage) and sah(sub arachnoid hemorrhage). in the second phase, the project will be doing national and international surveys of best practices among comprehensive stroke centers and then combine evidence based guidelines and recommendation as well as expert consensus and guidelines when high level evidence is not available from the published literature. the aim to improve public stroke awareness, stroke symptom recognition within the time benefit window for treatment and calling 9-1-1, ems transportation, and the proportion and speed of reperfusion therapy (fibrinolytic and in appropriate patients- endovascular treatment) in eligible patients. these improvements in acute stroke care delivery are expected to result in lower mortality, fewer recurrent strokes, and improved long term functional outcomes that we will measure.

Eligibility criteria:
inclusion criteria: * adult patients \> 18 years of age who undergo the local acute code stroke process exclusion criteria: * in house patients with stroke are not included in this data set.
a dose- and efficacy-finding study of ro5323441 in combination with avastin (bevacizumab) in patients with recurrent glioblastoma

Conditions: Glioblastoma Multiforme

Summary: this open-label, multicenter study will evaluate the safety and efficacy of ro5323441 in combination with avastin (bevacizumab) in patients with recurrent glioblastoma. in the dose-finding part, patients will receive intravenous escalating doses of ro5323441 in combination with 10 mg/kg avastin once every two weeks. in the efficacy-finding part, patients will be randomized to receive the established dose (from the dose-finding part) of ro5323441 plus avastin or avastin alone. patients in the dose-finding part may continue treatment with ro5323441 and avastin on the study until evidence of progressive disease or unacceptable adverse events happen. in the efficacy-finding part, patients will receive study treatment until disease progression or death.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * histologically confirmed glioblastoma * radiographic demonstration of disease progression by response assessment in neurooncology (rano) criteria following prior therapy * availability of at least 1 formalin-fixed paraffin-embedded tumor tissue sample * if receiving corticosteroids, patients must have been on a stable or decreasing dose of corticosteroids * prior standard radiotherapy for glioblastoma * karnofsky performance status \>/=70 * over 4 weeks since prior surgical resection * over 12 weeks from radiotherapy * over 4 weeks from anticancer agents exclusion criteria: * patients had second or later glioblastoma relapse * patients received more than one systemic treatment regimen for glioblastoma * patients have secondary glioblastoma * prior treatment with avastin * patients unable to undergo magnetic resonance imaging (mri)
clinical assessment of a daily wear monthly replacement soft silicone hydrogel contact lens

Conditions: Myopia

Summary: the purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.

subjects will wear two products and be expected to attend 4 office visits. the individual duration of participation will be approximately 60 days (30 days for each product).

Eligibility criteria:
key inclusion criteria: * able to understand and sign an approved informed consent form; * willing and able to attend all scheduled study visits as required by the protocol; * current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day; * other protocol-defined inclusion criteria may apply. key exclusion criteria: * current or prior biofinity contact lens wearer in the past 3 months; * monovision contact lens wearer; * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses