Kornimate/medical-research-clean huggingface dataset:
remission and joint damage progression in early rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.


Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis (ra) \<=2 years; mtx naive or \<=10 mg/wk for \<=3 weeks. no dose within 3 months prior to informed consent. * c-reactive protein (crp) \>= 4.5 mg/l (after amendment) * rheumatoid factor or anti-cyclic citrullinated peptide antibody (anti-ccp) positive * tender joints \>=12 and swollen joints \>=10 exclusion criteria: * women and men who are not willing to use birth control * diagnosed with other rheumatic disease * history of cancer within 5 years * active tuberculosis * treatment with another investigation drug within 28 days * active bacterial or viral infection

Keywords: abatacept, methotrexate, erosive ra
vasoactive peptides in portal pressure

Conditions: Portal Hypertension

Summary: this study is looking at the detection of vasoactive peptides in portal hypertension.


Eligibility criteria:
inclusion criteria: * hvpg \>= 12 mmhg

Keywords: hvpg > 12 mmhg
pain management for pectus excavatum repair

Conditions: Postoperative Pain

Summary: the objective of this study is to scientifically evaluate two different management strategies for post-operative pain after pectus excavatum repair. the hypothesis is that pain management without an epidural decreases hospital stay without compromising comfort. the primary outcome variable is length of hospitalization after the intervention.

this will be a single institution, prospective, randomized clinical trial involving patients who undergo the minimally invasive repair of a pectus excavatum deformity with bar placement. this is intended to be a definitive study. power calculations based on the known length of hospitalization listed above with α = 0.05 and power of 0.8 show the need for 55 patients in each arm. the primary end point will be reached during the hospital stay; therefore, we expect a very small amount of attrition and will intend to recruit 110. one group will undergo an attempt for epidural regional analgesia (epidural) for post-operative pain control. the other groups will receive patient controlled intravenous systemic analgesia (pca). both groups will have the same management algorithm. all data will be analyzed on intention-to-treat basis.

Eligibility criteria:
inclusion criteria: * patients undergoing a pectus excavatum repair with bar placement. exclusion criteria: * open repair * re-do operation * known allergy to a pain medication in the protocol * existing contraindications to epidural catheter placement * requirement for 2 bars to be placed (rare) * inadequate baseline cognitive function to understand/respond to vas questionnaire

Keywords: pectus excavatum bar repair pain control pectus excavatum repair
preemie: study for treatment of pda in premature infants

Conditions: Patent Ductus Arteriosus (PDA)

Summary: this multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of the bloom micro occluder system for the treatment of patent ductus arteriosus (pda) in pre-mature infants over a period of 6 months.


Eligibility criteria:
inclusion criteria: * subject is age ≥5 days at time of enrollment. * subject has a diagnosis of a hemodynamically significant patent ductus arteriosus (pda) requiring closure. * subject has a pda is ≤4.0 mm in diameter. * subject has a pda is ≥5 mm in length. * subject's weight is between 600-2500 grams at time of enrollment. exclusion criteria: * subject has pre-existing coarctation of the aorta. * subject has pre-existing left pulmonary artery stenosis. * subject has an intracardiac thrombus that may interfere with the implant procedure * subject has other known hemodynamically significant congenital heart disease conditions at time of enrollment requiring intervention, e.g., valvular atresia, tetralogy of fallot, atrial septal defect, ventricular septal defect, transposition of the great vessels, etc. * subject has an active systemic infection at the time of enrollment.
beetroot juice effects on contractile or neuromuscular properties in male trained sprinters

Conditions: Nitrates; Placebo

Summary: beetroot juice is a rich source of nitrate (no3-), which serves as a precursor to nitric oxide (no) via the no3- to nitrite (no2-) to no conversion pathway. this pathway is believed to enhance vasodilation and improve neuromuscular function, such as by increasing sarcoplasmic reticulum calcium release and re-uptake, leading to enhanced force production in type ii muscle fibers and improved muscle contractile recruitment. therefore, the aim of this study was to investigate the effects of beetroot juice supplementation on muscle contractile properties, as assessed by tensiomyography, and neuromuscular performance in sprint-trained athletes.

sports nutrition is a rapidly expanding scientific field that has experienced a significant increase in interest from the academic community over the past decade. despite the extensive marketing of numerous nutritional products that claim to optimize athlete health, function, and performance, only a limited number of sports foods or dietary supplements have been supported by robust evidence for enhancing performance. among these, caffeine, creatine, beetroot juice, β-alanine, and bicarbonate are notable for their validated efficacy, though the effectiveness of these supplements can vary based on the specific event, context of use, and the individual athlete's goals and responsiveness. beetroot juice, in particular, is a rich source of nitrate (no3-), which serves as a precursor to nitric oxide (no) through the no3- to nitrite (no2-) to no conversion pathway. this pathway is believed to promote vasodilation and improve neuromuscular function, such as by increasing sarcoplasmic reticulum calcium release and re-uptake, leading to enhanced force output in type ii muscle fibers and improved muscle contractile recruitment. therefore, the aim of this study was to investigate the effects of beetroot juice supplementation on muscle contractile properties, as assessed by tensiomyography, and neuromuscular performance in sprint-trained athletes. the goal was to gain a deeper understanding of the physiological effects induced by beetroot juice intake in short-distance track and field disciplines.

Eligibility criteria:
inclusion criteria: * between 18 to 40 years old. * with a regular training practise in track and field disciplines \&gt; 5 years. exclusion criteria: * intolerance to beetroot juice or no3- derivatives * presence of any chronic pathology or injury within three months prior to the study- * use of medications or supplements (e.g., caffeine) during the study. * failure to attend all experimental sessions. * failure to adhere to the dietary guidelines established in the study

Keywords: sport nutrition track and field tensiomyography athletes nitrates
co2-angiography-study to evaluate diagnostic and safety to patients with peripher arterial stenotic or occlusive disease.

Conditions: Peripheral Arterial Occlusive Disease

Summary: this randomized study focuses on the diagnostic quality and safety of co2 application as contrast medium through an innovative injector of angiodroid in angiography interventions in patients with peripheral arterial occlusive diseases.

co2-angiography was used as an intra-arterial contrast agent since the 1970s particularly in patients who were hypersensitive to iodinated contrast material or whose renal function was compromised. it is in fact an effective and low-risk alternative to iodine-enhanced conventional angiography because it is not associated with nephrotoxicity or allergic reactions. the image quality influencing the diagnostic validity seems to be a restriction. now, with the availability of high-resolution dsa and a reliable gas delivery system, co2 angiography is more and more widely used for vascular imaging and endovascular procedures. our study will specifically examine the image quality and safety of carbon dioxide gas as intra-arterial contrast agent using the innovative artis zeego q angiography-system of siemens healthineers with the automated co2-injection system of angiodroid.

Eligibility criteria:
inclusion criteria: * age \> 18 years * male, female * patients with indication for percutaneous transluminal angioplasty of iliacal- or femoropopliteal arteries exclusion criteria: * children and adolescents \< 18 years * diagnostic angiography, ct- or mri-angiography during the past 3 months * patients with reduced renal function (s-creatinine \> 1,2 mg/dl) * incapacitated patients * severe copd * known atrium- or ventricular septal defect with right-left-shunt * current participation in other interventional studies

Keywords: co2 angiography peripheral occlusion disease contrast medium carbon dioxid enhanced angiography
comparison of covered and bare stent in tips

Conditions: Cirrhosis

Summary: investigators aim to compare the efficacy of 8 mm fluency covered stent and bare stent in transjugular intrahepatic portosystemic shunt (tips) for the treatment of cirrhotic portal hypertension.

from january 2006 to december 2010, the covered (experimental group) or bare stent (control group) was used in 131 and 127 patients, respectively. the recurrence rates of gastrointestinal bleeding and refractory hydrothorax/ascites, the cumulative restenosis rates in 1, 2, 3, 4, and 5-years, the incidence rate of hepatic encephalopathy, the rate of secondary interventional therapy, the 1, 2, 3, 4 and 5-year survival rates were compared between the experimental group and the control group.

Eligibility criteria:
inclusion criteria: 1. portal hypertension patients with defined indications for tips treatment; 2. scheduled for elective tips; and 3. aged between 18-70 years. exclusion criteria: 1. combined with hepatic encephalopathy before the treatment; 2. combined with portal vein thrombosis; 3. combined with malignant liver tumor or malignancies at the other sites; or 4. combined with hemorrhage of gastrointestinal ulcer.

Keywords: tips hepatocellular carcinoma portasystemic shunt
prediction of leg length discrepancy after unilateral total knee replacement in varus deformity

Conditions: Total Knee Replacement

Summary: to what degree total knee replacement (tka) affects leg length discrepancy in patients with varus deformity? varus deformity, the most commonly encountered deformity in patients undergoing tka is associated with limb alignment and varying degrees of contractures of medial soft tissue structures, laxity of the lateral soft tissue structures, flexion deformity and medial bone erosion at the knee joint .the challenges in performing tka in a varus arthritic knee include restoration of limb alignment, balancing the medial and lateral soft tissue tension, equalizing flexion and extension gaps and restoring medial bone loss

limb length discrepancy (lld)less than 2cm is usually not noticeable and does not require treatment. lld over 2cm is usually noticed by the individual affected leading to self compensation by walking on the ball of the foot (toe down) or by tilting the pelvis and curving the spine.untreated lld can lead to lower back pain and long leg arthritis of the hip lld and its effects on patient function have been discussed in depth in the literature with respect to hip arthroplasty but there are few studies that have examined the effect on function of limb length discrepancy following tka. improved surgical techniques and rehabilitation protocols have resulted in excellent knee function and range of motion following tka. the investigators are aiming from the study to improve functional outcome in patients with knee osteoarthritis undergoing tka.

Eligibility criteria:
inclusion criteria: - 1-cases of osteoarthritis of the knee with varus deformity undergoing unilateral tka. 2-cases with previous unilateral tka undergoing tka of the other side. exclusion criteria: * 1-cases of osteoarthritis of the knee with valgus deformity. 2-revision total knee replacement cases. 3-patients with total hip replacement. 4-extra-articular lower limb deformities. 5-cases of bilateral tka done at same setting. 6-patients with previous knee surgery. 7-patients with complicated inrta-operative tka .
a study in pediatric patients with cystic fibrosis lung disease

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to investigate the safety and effectiveness of two dose strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (cf).


Eligibility criteria:
inclusion criteria: * have confirmed diagnosis of cf * have an fev1 greater than or equal to 60% * have oxygen saturation greater than or equal to 90% on room air * be clinically stable for at least 4 weeks prior to screening * be able to reproducibly perform spirometry maneuvers exclusion criteria: * have clinically significant comorbidities * have changed their physiotherapy technique or schedule within 7 days prior to screening * using prior and concurrent medications according to protocol

Keywords: lung disease
myo-inositol in obese pregnant women

Conditions: Gestational Diabetes

Summary: myo-inositol is classified as a member of the vitamin b complex. it is a constituent of living cells and is widespread in many food. it is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. this is a prospective, randomized, double center, placebo-controlled study. two hundred and twenty obese pregnant women will be included in the trial and, after an informed consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks gestation until delivery. then,they will perform an oral glucose tolerance test (ogtt) at 24-28th weeks gestation. records about delivery (gestational age, neonatal weight...) will be registered.


Eligibility criteria:
inclusion criteria: * obese pregnant women: bmi \> 30 kg/cm2 * first trimester fast glycaemia \< 126 mg/dl * single pregnancy exclusion criteria: * pregnant women with bmi \< 30 kg/cm2 * first trimester fast glycaemia \> 126 mg/dl * previous gestational diabetes * twin pregnancy * pregestational diabetes * associated therapies with corticosteroids

Keywords: gestational diabetes macrosomia hypertension in pregnancy homa-ir obesity
a follow-up assessment of resistance to abt-333 in hepatitis c virus (hcv)-infected subjects who have received abt-333 in abt-333 studies

Conditions: HCV Infection

Summary: the purpose of this follow-up study is to evaluate the frequency and persistence of specific viral mutations in response to treatment with abt-333 (dasabuvir).

this phase 2, multicenter study was conducted in hcv-infected participants who received abt-333 at any dose level or matching placebo in a prior clinical study involving abt-333. hepatitis c virus (hcv)-infected participants who received abt-333 at any dose level or matching placebo in study m10-351 substudy 2 (nct00696904; abt-333 dosing duration was 2 days) and study m10-380 (nct00851890; abt-333 dosing duration was 28 days) were eligible. after receiving at least 1 dose of abt-333 or placebo, subjects were assessed for participation in this rollover study and asked to review the informed consent. the day of study completion or early discontinuation from the prior abt-333 clinical study served as the baseline assessment. if it was found that a participant received placebo during the previous abt-333 clinical study, the sites were instructed to discontinue the participant from this study. this study included approximately monthly blood sample collection procedures for 48 weeks, and no treatment was provided during this time.

Eligibility criteria:
inclusion criteria: - main selection criteria: subject received abt-333 or matching placebo in a prior clinical study involving abt-333. exclusion criteria: - the investigator considers the subject unsuitable for the study for any reasons inclusive of, but not limited to, failure to comply with study procedures in prior abt-333 clinical study.

Keywords: hcv infection
a study to evaluate the safety and effectiveness assessments of restylane-defyne for punctual occlusion

Conditions: Dry Eye

Summary: a study which participants with mild to moderate dry eye disease will have a punctum of one eye injected with 0.1ml restylane defyne and the other eye injected with 0.2ml restylane defyne. participants will be evaluated over four visits.


Eligibility criteria:
inclusion criteria: * 21 to 80 years of age * baseline osdi score of at least 13 with no more than 3 responses of "not applicable" * in both eyes, a baseline schirmer test with anesthetic of ≤ 10mm/5 minutes * literate, able to speak english and able to complete the questionnaire independently * willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol. exclusion criteria: * use of ophthalmic cyclosporine or lifitegrast within 30 days prior to day 0 * history of surgical punctal occlusion (e.g., cautery), canalicular infection or canalicular surgery * corneal transplant in either eye * ocular surgery (such as cataract surgery or lasik) in either eye within six months of the baseline visit * a systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease) * the history or presence of any ocular disorder or condition in either eye that, in the opinion of the investigator, would interfere with the interpretation of the study results (e.g., significant corneal or conjunctival scarring, pterygium or nodular pinguecula; current ocular infection (except mild blepharitis), conjunctivitis or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; history of ocular herpetic infection; evidence of keratoconus; lid or lacrimal cancer. * active severe systemic allergy, seasonal allergies, rhinitis or sinusitis requiring changes in treatment within 30 days prior to the study or likely to require changes in treatment during the course of the study (i.e. antihistamines, decongestants, oral, topical or aerosol steroids) * participation in a clinical trial during the past 30 days * women who are pregnant, planning a pregnancy, or nursing at study entry.

Keywords: dry eye disease restylane-defyne
aplastic anemia epidemiology: incidence and case-control

Conditions: Blood Disease; Anemia, Aplastic

Summary: to conduct incidence and case-control studies of aplastic anemia in metropolitan bangkok, thailand

background: aplastic anemia, a form of bone marrow failure, is a disease of largely unknown cause, except for the rare situations involving high doses of radiation. many agents have been mentioned in case reports to be associated with the development of aplastic anemia and include drugs, chemicals, pesticides, radiation, and viral infection. of these, chloramphenicol, phenylbutazone, and insecticides are most frequently reported. in the united states and other developed countries the disease prevalence is so low that too few cases occur to make an epidemiological study in a single city logistically feasible. the bangkok hospitalization rate for aplastic anemia was sufficient to conduct a case-control study. also, a study conducted in this locale provided information on drugs and chemicals not commonly used in developed countries. design narrative: all aplastic anemia cases in metropolitan bangkok were located and verified in the forty hospitals that agreed to participate in the study. incidence rates were calculated by age group and sex. in the case-control study, interviews were used to obtain comprehensive histories of drug, chemical, pesticide, radiation, viral infections, and other exposures, along with relevant demographic and medical history information in order to examine the association between and test hypotheses regarding suspected hazards and to estimate the risks of developing aplastic anemia. the basic epidemiologic features of aplastic anemia were described by characterizing these patients in terms of standard demographic variables, age, race, sex, and medical history. the degree of association between viral hepatitis and the development of aplastic anemia was estimated. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
cer-1236 in patients with acute myeloid leukemia (aml)

Conditions: AML; Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia

Summary: this is a ﬁrst in human, multi center, open label, phase 1/1b study to evaluate the safety and preliminary efﬁcacy of cer-1236 in patients with relapsed/refractory (r/r), measurable residual disease (mrd) positive acute myeloid leukemia (aml), or tp53mut disease.

cer-1236 is a first in class chimeric engulfment receptor t-cell therapy candidate that targets the tim4 ligand. this is a ﬁrst in human, multi center, open label, phase 1/1b study to evaluate the safety and preliminary efﬁcacy of cer-1236 in patients with relapsed/refractory (r/r), measurable residual disease (mrd) positive acute myeloid leukemia (aml), or tp53mut disease. the study is divided into part 1 (escalation phase) and part 2 (expansion phase). part 1 (escalation phase): the primary objectives of part 1 are to deﬁne the safety of different doses of cer-1236 and to deﬁne the recommended dose for part 2 (rp2d) of cer-1236. part 2 (expansion phase): the objective of the part 2 expansion cohort is to evaluate the safety and efﬁcacy of cer-1236 in patients with acute myeloid leukemia.

Eligibility criteria:
inclusion criteria: * patients need to have a confirmed diagnosis of de novo or secondary aml, or myelodysplastic syndrome (mds)/aml with 10% to 19% blasts, per the international consensus classification 2022 or the who 2022 classification. * absolute lymphocyte count \>0.3 x 109/l prior to apheresis. * eastern cooperative oncology group (ecog) performance status 0 to 1. exclusion criteria: * prior therapy with a permanently integrated, genetically modified cell product. * no measurable leukemia on the screening bone marrow evaluation prior to any bridging therapy. * active autoimmune disease or history of autoimmune disease requiring treatment within the prior 2 years. patients with history of autoimmune thyroiditis or type 1 diabetes well controlled on replacement regimen are eligible. * a known hypersensitivity or severe allergy to fludarabine, cyclophosphamide, or study drug components or diluents. * any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the physician. * primary immunodeficiency disorder.

Keywords: relapsed acute myeloid leukemia