Kornimate/medical-research-clean huggingface dataset:
a double-blind, placebo-controlled study with open-label follow-up to determine the safety and efficacy of r-huepo in aids and advanced arc patients with anemia

Conditions: HIV Infections; Cytopenias

Summary: to determine the safety and efficacy of r-huepo administration to patients with aids or advanced aids related complex (arc) and anemia secondary to their disease.


Eligibility criteria:
exclusion criteria co-existing condition: patients with the following are excluded: * history of any primary hematologic disease. * hiv disease related dementia. * uncontrolled hypertension (diastolic blood pressure \> 100 mmhg). * presence of concomitant iron deficiency. * anemia attributable to factors other than hiv disease or zidovudine (azt) therapy. * acute opportunistic infection. * history of seizures. * clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying hiv disease. concurrent medication: excluded: * zidovudine (azt) therapy during the double-blind phase of study. patients with the following are excluded: * history of any primary hematologic disease. * clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying hiv disease. * hiv disease related dementia. * uncontrolled hypertension (diastolic blood pressure \> 100 mmhg). * presence of concomitant iron deficiency. prior medication: excluded within 30 days of study entry: * experimental drug or experimental device. * cytotoxic chemotherapy. * excluded within 2 months of study entry: * androgen therapy. * zidovudine (azt) therapy and during the double-blind phase. clinical diagnosis with aids or aids related complex (arc) and related anemia. * clinical diagnosis of aids or arc. * clinically stable for 1 month preceding study entry. * patients should preferably be transfusion dependent. substance abuse.

Keywords: recombinant proteins erythropoietin acquired immunodeficiency syndrome anemia aids-related complex zidovudine
the six-minute walking test (6wt) and timed-up-and-go (tug) test as measures of objective functional impairment in patients undergoing interlaminar or transforaminal epidural steroid injection for lumbar degenerative disc disease (ddd)

Conditions: Lumbar Disc Disease; Lumbar Spine Degeneration; Lumbar Spinal Stenosis

Summary: the primary objective is to determine the validity of the six-minute-walking test (6wt) and timed-up and go (tug) test to measure objective functional impairment (ofi) in patients undergoing either interlaminar epidural steroid injection (esi) or transforaminal epidural steroid injections (tfesi) for lumbar degenerative disc disease (ddd)

the purposes of the project are to assess the ability of the six-minute-walking test (6wt) and timed-up and go (tug) test to measure and classify the disease burden, and to determine their relation to already established subjective patient reported outcome measures (proms)in patients treated with either interlaminar epidural steroid injection (esi) or transforaminal epidural steroid injections (tfesi) for lumbar degenerative disc disease (ddd). no research has so far determined its validity to determine ofi in a cohort of patients managed conservatively. we want to use an existing smartphone-applications for the 6wt and tug test. applying self-measurement of the 6wt within the context of a two center observational study will determine ofi in patients before and after (tf)esi. the results of this study add to the understanding of achievable objective outcomes after steroid injection applied to patients with ddd.

Eligibility criteria:
inclusion criteria: * patient with symptomatic lumbar degenerate disc disease (ddd), scheduled for either either interlaminar epidural steroid injection (esi) or transforaminal epidural steroid injections (tfesi) * male and female subjects ≥ 18 years * written informed consent exclusion criteria: * pregnancy * inability to walk (extreme pain or severe neurological deficits) * severe chronic obstructive lung disease (copd) corresponding to ≥ gold iii * severe heart failure corresponding to ≥ new york heart association (nyha) iii * lung cancer and diffuse parenchymal lung disease * other medical reasons interfering with the patient's ability to walk and perform the 6wt/tug (e.g., osteoarthritis disease of the lower extremities, parkinson's disease, heart failure, hip or knee prosthesis etc.) * unavailability for follow up and/or inability to complete assessment (planning to move, no smartphone, etc.).
telephone outreach by navigators to improve repeat fecal occult blood testing

Conditions: Colorectal Cancer Screening

Summary: to conduct a randomised control trial to test the effectiveness of telephone outreach programme to improve the uptake rate of repeat fecal occult blood test in colorectal cancer screening programme.

the colorectal cancer screening programme(crcsp) adopts a two-tier approach, offering faecal occult blood test (fobt) by fit as first line screening followed by colonoscopy examination for cases with positive fit result. under the crcsp, participants with negative or uninformative fit result in the first round should be re-screened after 24 months. the objective is to conduct a randomised control trial to test the effectiveness of telephone outreach programme to improve the uptake rate of repeat fecal occult blood test in crcsp.

Eligibility criteria:
inclusion criteria: * participants of crcsp born between 1949 and 1951 with negative or uninformative fit result in the first screening round who are due for second rescreening round for at least 4 months but did not turn up for rescreening exclusion criteria: * nil
a phase iii study to investigate the impact of diamyd in patients newly diagnosed with type 1 diabetes (usa)- diaprevent

Conditions: Type 1 Diabetes Mellitus

Summary: the intended purpose of this study was to determine whether diamyd (rhgad65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes. based on results from other clinical trials with the study drug it was judged unlikely this study would meet the intended primary or secondary efficacy endpoints. therefore the primary focus of this study was changed to ensure that safety data was available for at least 6 months following the last dose of active study drug. thereafter the study was terminated.


Eligibility criteria:
main inclusion criteria: * insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening * fasting c-peptide level at time of screening above 0.1 nmol/l * elevated gad65 antibodies (gada) at time of screening * male and female patients between 10 and 20 years of age main exclusion criteria: * treatment with immunosuppressants or any anti-diabetic medications other than insulin * a history of certain diseases or conditions (e.g. anemia, hiv, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc) * treatment with any vaccine within 1 month prior to planned first diamyd dose or planned treatment with vaccine up to 2 months after the last injection with diamyd, excluding the influenza vaccine * participation in other clinical trials with a new chemical entity within the previous 3 months * pregnancy or planned pregnancy within 1 year after the last diamyd dose * presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study

Keywords: diabetes juvenile diabetes diabetes type 1 autoimmune diabetes insulin dependent diabetes type 1 diabetes type 1 diabetes mellitus diamyd rhgad65 gad gad-alum
the associations of plasminogen activator inhibitor-1 gene polymorphisms with crohn's disease in chinese patients

Conditions: Crohn Disease

Summary: from january 2020 to january 2025, crohn's disease (cd) patients and gender- and age-matched normal controls were collected from the department of gastroenterology, the second affiliated hospital of wenzhou medical university. the aim of this research is to explore the associations of plasminogen activator inhibitor-1 (pai-1) gene polymorphisms with the risk and clinicopathological characteristics of cd, and to analyze the effects of pai-1 gene variantions on the clinical response of ustekinumab (ust) treatment in cd patients at week 8.

from january 2020 to january 2025, a total of 311 cd patients and 495 gender- and age-matched normal controls were collected from the department of gastroenterology, the second affiliated hospital of wenzhou medical university.the genotypes of pai-1 were determined by multiplex polymerase chain reaction-ligase detection reaction technique. unconditional logistic regression was employed to analyze the distribution of pai-1 gene polymorphisms between cd group and normal control group, as well as their influences on the clinicopathological characteristics of cd patients. multi-model logistic regression was used to explore the effect of pai-1 gene variation on the clinical response of cd patients in the treatment of ust at week 8.

Eligibility criteria:
inclusion criteria: diagnosed cd based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results exclusion criteria: rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.
added value of oct for diagnosing recurrent bcc after non-invasive treatment

Conditions: Basal Cell Carcinoma

Summary: superficial basal cell carcinoma (sbcc) can be treated non-invasively, but follow-up is necessary because lesions can reoccur. this study aims to evaluate the additional value of optical coherence tomography (oct) for the detection of recurrent bcc lesions, that may remain unrecognized by clinical and dermoscopic examination (cde). this study compared the diagnostic accuracy of cde and cde combined with oct for detection of recurrent basal cell carcinoma (bcc) after non-invasive treatment of sbcc.


Eligibility criteria:
inclusion criteria: * non-invasively treated sbcc patients * 18+ years of age exclusion criteria: * unable to sign informed consent

Keywords: optical coherence tomography
a dose finding study of idh305 with standard of care in idh1 mutant acute myeloid leukemia

Conditions: Acute Myeloid Leukemia (AML)

Summary: the purpose of this study is to evaluate the safety, tolerability and potential efficacy of idh305 with standard treatments for newly diagnosed idh1r132 mutant acute myeloid leukemia (aml).


Eligibility criteria:
inclusion criteria: -- previously untreated aml. patients with untreated, high or very high risk mds (according to ripss or equivalent) are also permitted in arm 2. * documentation of idh1r132 mutation of tumor * ecog performance status ≤ 2 * clinically fit for standard of care medication per protocol. exclusion criteria: * prior treatment for aml or mds * any severe or uncontrolled medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease. * acute promyelocytic leukemia * women who are pregnant or lactating other protocol-defined inclusion/exclusion may apply

Keywords: newly diagnosed acute myeloid leukemia aml myeloid dysplastic syndrome mds idh305 standard of care in idh1 mutant acute myeloid leukemia
effect of type ii diabetes mellitus with neuropathy on the clinical use of rocuronium

Conditions: Neuromuscular Transmission Disorder; Diabetes Mellitus, Type 2

Summary: international diabetes federation estimates that there are now 415 million adults aged 20-79 with diabetes mellitus worldwide. by 2040 this will rise to 640 million. although diabetes mellitus is highly prevalent in our environment and one of the most important challenges of modern medicine, only a handful of studies have examined the neuromuscular function in diabetic patients. the shortage of publications in this area is still more surprising if we consider that the neuromuscular blockers are one of the pillars in the administration of general anesthesia. neuromuscular blockers during surgery are used in tracheal intubation and to improve surgical conditions.

in diabetic patients, neuropathy, microvascular and macrovascular complications are known clinical findings which require attention during anesthesia. partial degeneration or segmental demyelination of the nerve fibers and loss of motor units have been reported in patients with diabetes mellitus as well. therefore, the effects of a neuromuscular blocking agent should be important because of potential complications from incomplete reversal or residual paralysis during anesthesia maintenance. in a series of studies, vecuronium has been the only agent investigated in patients with diabetes mellitus and other diseases characterized by neuromuscular dysfunction. delayed recovery from the neuromuscular block after vecuronium administration was shown in patients with diabetes mellitus. currently, rocuronium, with its rapid onset of action, rapid recovery profile and inactive metabolites, is generally known as a safe agent for anesthesia under normal conditions. it is known that the pharmacokinetic properties of rocuronium can be altered in some diseases, such as renal or hepatic failure. however, it has not been investigated whether the effect of rocuronium on neuromuscular function is changed in the presence of neuropathy in diabetes mellitus patients or not. the rationale of our study arises from the finding of many studies that show different changes in the neurophysiological parameters in diabetes mellitus. in diabetic nerve, the conduction velocity of the action potential is decreased, the amplitude of action potentials, both sensory and motor, is smaller, and the latency time is elongated.

Eligibility criteria:
inclusion criteria: * adult patients aged from 18 years to 65 years. * scheduled for abdominal surgery under general anesthesia exclusion criteria: * patients with allergy to rocuronium * those diagnosed with diseases that alter neuromuscular blocker response (e.g., guillain-barré syndrome, duchenne type muscle dystrophies, etc.), * patients receiving treatment with drugs capable of altering neuromuscular transmission or neuromuscular blocker response (e.g., antiseizure drugs, certain antibiotics, etc.).

Keywords: diabetes mellitus neuromuscular transmission
a study of cm512 in subjects with moderate-to-severe chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: a randomized, double-blind, placebo-controlled, parallel group, phase ii study to explore the efficacy and safety of cm512 injection in adults with moderate-to-severe chronic obstructive pulmonary disease (copd)

this is a phase ii, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of cm512 in adults with moderate-to-severe chronic obstructive pulmonary disease (copd) receiving triple or double inhaled maintenance therapy, and having had 1 or more documented copd exacerbations in the 12 months prior to visit 1. subjects will receive cm512, or placebo, administered via subcutaneous injection at the study site, over a 52 week treatment period. the study also includes a post-treatment follow-up period of 12 weeks.

Eligibility criteria:
inclusion criteria: * 40 to ≤ 80 years old * bmi ≥ 18.0 kg/(m\*m) * copd diagnosis≥1 year * post-bd fev1 ≥ 30% and \< 80%, fev1/fvc \<0.70 at screening * triple (laba+lama+ics) or dual inhaled (laba+lama or laba+ics) copd therapy ≥3 months prior to v1 * 2 moderate or ≥1 severe copd exacerbations in the prior year * cat ≥10 at screening * former or current smokers ≥10 pack-years exclusion criteria: * clinically important pulmonary disease other than copd, as judged by the investigator (including current or historic asthma diagnosis). * any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable. * treatment with oxygen of more than 15 hours per day. * pregnant or breastfeeding. * the chest/lungs with pathology that precludes the patient's ability to complete the study.
evaluation of safety and effectiveness on oral anticoagulants

Conditions: Atrial Fibrillation

Summary: this study is to compare the risk of major bleeding among oral anticoagulant (oac)-naïve non-valvular atrial fibrillation (nvaf) patients initiating treatment


Eligibility criteria:
inclusion criteria: * individuals greater than or equal to 20 years old as of the index date * at least 1 diagnosis of nvaf prior to or on index date, identified by any medical records * newly treated with warfarin or apixaban between 01-jan-2011 to 31-dec-2016. the first warfarin or apixaban prescription date during the identification period will be designated as the index date exclusion criteria: * patient's medical records indicating pregnancy during the follow-up period * patient's medical records indicating taking warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 6-months prior to the index date * had \> 1 oac prescription in the patient's medical records on the index date other protocol defined inclusion/exclusion criteria could apply
effect of pelvic floor stimulation on the pelvic floor function in cervical cancer patients with type iii hysterectomy

Conditions: Lower Urinary Tract Symptoms

Summary: the purpose of this study is to investigate the effect of electric stimulation on the pelvic floor function in cervical cancer patients with type iii hysterectomy.

this is a prospective, multi center, open, randomized, controlled clinical trial. all cervical carcinoma patients who undergo type iii hysterectomy in the hospitals involved in this study were recruited. 5-7 days postoperative, those who meet the inclusion criteria and without the exclusion criteria and sign the consent were randomized grouped of intervention and control objective by 1:1. at the same time, according to the research hospital, menopausal status (menopause vs menopause) and surgery approach (laparoscopic vs open)，they were further stratified randomly. patients in the intervention group received electrical stimulation treatment based on conventional clinical nursing, while patients in control group only receive routine clinical care. except for the treatment of electrical stimulation, other research procedures is the same in the two groups. the recovery rate of urination function, pelvic floor function and life quality of the two group is compared.

Eligibility criteria:
inclusion criteria: * patients diagnosed as cervical squamous cell carcinoma on ⅰa2, ib1 or ⅱa1 stage * type iii hysterectomy * there are pathological results showing that cancer resection clean and no distant metastasis,specifically as follows:lymph nodes(-);cancer foci invasion depth \<1/2;lymphatic space(-);vaginal stump(-);differentiation g1-2. * patients agreed to the study, informed consent exclusion criteria: * radiotherapy and chemotherapy before surgery * reserved nerve in the surgery * urinary system damage * pop(pelvic organ prolapse stage)\>ii stage before surgery * moderate above stress urinary incontinence(sui) before surgery(1 hours urine pad test\>=10g) * urinary retention before surgery * severe constipation or difficult defecation before surgery * there are uncontrolled epilepsy, central nervous system disease or mental disorder history in patients.the clinical severity of these diseases influence clinical research compliance,judging by the researcher.

Keywords: electrical stimulation urinary incontinence
evaluation of the patient safety screening tool (psst) for sepsis

Conditions: Sepsis

Summary: the patient safety screening tool (psst) for sepsis solution is a tool to assist with the early detection of sepsis and management of the administration of bundle packages as defined by the institute for healthcare improvement (ihi). this web based application relies on integration with bedside medical equipment (bme) data as well as lab and registration data so that clinical workflow items can be automated in the fight against sepsis.

the workflow that is automated by the psst for sepsis solution is tightly integrated with registration, bedside monitoring equipment (bme), and lab data. as patients arrive in the unit, workflow activities are started with patient context. typical implementations of the ihi guidelines for sepsis screening dictate that patients are rescreened on regular intervals to detect sepsis. the psst for sepsis solution will monitor lab and bme data stores and continually update the screening forms for a particular patient. it will also alert clinicians when a manual screen is required in the microsoft infopath form. the constant screening loop is managed by the psst for sepsis solution and will continue to run until the patient screens positive for severe sepsis, or moves to the next workflow of auditing a patient with sever sepsis. when patients reach a state of "positive screen" (either manually, or through the automated data monitors) the psst for sepsis solution will move this patient from a screening workflow to an auditing workflow automatically. the psst for sepsis solution will then monitor the treatment process through microsoft infopath form posts and alert clinicians when treatment goals have not been met. after a successful auditing process and completion of the 6 and 24 hour bundles, the patient will be placed back into a screening workflow. the end result is that patients will remain in a screening/auditing workflow loop until the patient is discharged from the unit.

Eligibility criteria:
inclusion criteria: * patients that are hospitalized in the neuro care unit (ncu) * patients that are hospitalized in the vanderbilt burn center * patients must be \> 18 years of age exclusion criteria: * patients \< 18 years of age

Keywords: psst sepsis neuro care unit surviving sepsis campaign ssc
rapidshock post-approval study

Conditions: Cardiac Arrest

Summary: compare the performance of the reconfirmation analysis mode algorithm to the performance goals recommended by the american heart association.


Eligibility criteria:
inclusion criteria: * 8 years of age or older and weight ≥ 55 lbs (25 kgs) * out-of-hospital cardiac arrest (oohca) * non-traumatic cardiac arrest exclusion criteria: * weight less than 55 lbs (25 kgs) * do not attempt resuscitation (dnar) orders
observational study of sifrol® in patients with primary restless legs syndrome (rls)

Conditions: Restless Legs Syndrome

Summary: study to evaluate treatment effect of pramipexole on rls severity as measured by irls, cgi-i and rls-6 and to evaluate the time needed to reach maintenance dose of pramipexole (ppx)


Eligibility criteria:
inclusion criteria: * patients suffering from primary rls who are planned to be initiated on treatment with pramipexole as part of the routine care could be included into the study * patients not pre-treated with any dopaminergic agent (de novo patients) or patients pretreated with dopaminergic medication * male or female patients of any age exclusion criteria: * treating physicians are asked to consider the regulations described in the summary of product characteristics (spc) for the treatment with pramipexole