Kornimate/medical-research-clean huggingface dataset:
the effect of perioperative and postoperative music reduces pain perception after anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Tear

Summary: study the effect of music therapy in pre-operative and post operative period and measure the out come by the visual analog scale (pain score) and analgesic drug use such as morphine and the anxiety score

objectives primary objective : to study and compare pain symptoms between the group of patients after undergoing anterior cruciate ligament reconstruction surgery and the control group, using pain relievers along with listening to music perioperatively and postoperatively. secondary objective : to study and compare the levels of anxiety and changes in the circulatory system among patients after undergoing anterior cruciate ligament reconstruction surgery and the control group, from listening to music perioperatively and postoperatively. research questions does listening to music perioperatively and postoperatively during arthroscopic anterior cruciate ligament reconstruction surgery help reduce postoperative pain? hypothesis the group of patients who listened to music perioperatively and postoperatively during arthroscopic anterior cruciate ligament reconstruction surgery will experience reduced postoperative pain compared to the group that did not listen to music. methodology randomized controlled trial (rct) sample size calculation the calculation of the sample size for testing two independent means, using the method referenced from the study by xavier c. simcock and colleagues on "intraoperative music reduces perceived pain after total knee arthroplasty total 38 and add 20% for dropout rate inclusion criteria 1. patient age : more than 18 years old 2. the patient have diagnosis acl injury by mri and go on surgery by arthroscopic surgery exclusion criteria 1. history of knee surgery before this visit 2. acl injury with multiple ligament injury 3. hearing loss 4. denial to surgery or include to study study design \& method this study was a randomized control trial of patient knowns acl injury and undergoing arthroscopic acl reconstruction surgery between 2022 to 2023. a total 46 patients were included 23 patients in intervention and 23patients in control group. all patients were evaluated using vas and anxiety scale preoperative and postoperative and intravenous analgesic drug use at 1,3,12,24,48,72 hours after surgery.

Eligibility criteria:
inclusion criteria: * diagnosis anterior cruciate ligament tear from mri * plan to surgery by arthroscopic acl reconstruction * must able to listening music from headphone exclusion criteria: * hearing problem * history of morphine and pethidine allergy * history of previous knee surgery * intraoperative finding multiple ligament injury

Keywords: anterior cruciate ligament reconstruction music therapy postoperative pain pain score anxiety
a clinical trial of tolcapone in obsessive compulsive disorder

Conditions: Obsessive-Compulsive Disorder; OCD

Summary: the primary aim of the present study is to examine the efficacy and safety of tolcapone in adults with moderate to severe ocd.

based on the mechanism of action and our previous pilot data, the primary aim of the present study is to examine the efficacy and safety of 8-week treatment with tolcapone vs. placebo in adults with moderate to severe ocd, as indicated by a score of at least 21 on the yale brown obsessive compulsive scale (ybocs), a scale of illness severity, at the baseline visit. we hypothesize that tolcapone will significantly improve symptoms of ocd compared to placebo. a secondary aim of the proposed study is to examine the cognitive effects of tolcapone in ocd, by conducting objective neuropsychological tasks pre- and post-pharmacological trial. the rationale for this approach is that: dopamine plays a key role in cognition; cognitive effects of tolcapone are likely to be relevant in explaining symptomatic effects; and cognitive dysfunction constitutes an important treatment target in ocd that is not generally ameliorated by current first-line interventions. we hypothesize that any symptomatic benefit with tolcapone would also be associated with improvement in executive functions including cognitive flexibility. another secondary aim of the proposed study is to evaluate whether the single nucleotide polymorphism (snp) val-158-met polymorphism significantly relates to changes in symptoms and cognition observed with tolcapone. prior data indicate cognitive effects of tolcapone are affected by this snp. we hypothesize that the val/val comt variant will be associated with significantly higher tolcapone-related improvements in cognition and symptoms, since this is linked to lower cortical dopamine function.

Eligibility criteria:
inclusion criteria: 1. men and women age 18-65 years 2. primary diagnosis of ocd 3. ybocs score of at least 21 at baseline (moderate or higher severity) 4. ability to understand and sign the consent form exclusion criteria: 1. unstable medical illness based on history or clinically significant abnormalities on baseline physical examination 2. current pregnancy or lactation, or inadequate contraception in women of childbearing potential 3. subjects considered an immediate suicide risk based on the columbia suicide severity rating scale (c-ssrs) (www.cssrs.columbia.edu/docs) 4. history of psychosis or bipolar disorder based on dsm-5 criteria 5. alcohol/substance use disorder and/or illegal substance use based on urine toxicology 6. initiation of psychological interventions within 3 months of screening (those who are continuing with cbt will be included) 7. use of any new psychotropic medication within 3 months of study entry (stable doses of psychotropics will be allowed) 8. major cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent 9. abnormal liver function tests at baseline 10. madrs \>30 at baseline
study to evaluate the safety and efficacy of kite-585 in participants with relapsed/refractory multiple myeloma

Conditions: Relapsed/Refractory Multiple Myeloma

Summary: the primary objective of the study is to evaluate the safety and tolerability of kite-585, an autologous engineered chimeric antigen receptor (car) t-cell product targeting a protein commonly found on myeloma cells called b-cell maturation antigen (bcma), as measured by the incidence of dose-limiting toxicities (dlts). participants will be given a 3 day course of conditioning chemotherapy followed by a single infusion of kite-585.

participants with relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. tests required to determine eligibility include disease assessments, a physical exam, ecg and echocardiogram of the heart, brain mri, and blood draws. eligible participants have white blood cells collected by leukapheresis. these cells are genetically modified to make the experimental treatment kite-585. participants receive conditioning chemotherapy prior to the kite-585 infusion. after the kite-585 infusion, participants will be followed for side effects and effect of kite-585 on their myeloma. study procedures may be performed while hospitalized and/or in the outpatient setting. participants who received an infusion of kite-585 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, kt-us-982-5968

Eligibility criteria:
key inclusion criteria: 1. measurable relapsed or refractory myeloma as defined by the international myeloma working group (imwg) consensus criteria following treatment with at least 3 lines of therapy including with both a proteasome inhibitor (pi) and an immunomodulatory drug (imid), or progressive myeloma that is refractory to a regimen containing both a pi and an imid. 2. eastern cooperative oncology group (ecog) performance status of 0 or 1 3. adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as: * absolute neutrophil count (anc) ≥ 1,000/µl * platelet count ≥ 75,000/µl * absolute lymphocyte count ≥ 100/µl * creatinine clearance above limits set in the protocol for each cohort * normal cardiac function as assessed by electrocardiogram (ecg) and echocardiogram * baseline oxygen saturation \> 92% on room air and no clinically significant pleural effusion key exclusion criteria: 1. plasma cell leukemia 2. non-secretory multiple myeloma 3. history of central nervous system (cns) involvement by multiple myeloma 4. prior car therapy or other genetically modified t cells 5. inadequate washout from prior therapy 6. autologous stem cell transplant within 6 weeks before enrollment or any history of allogenic transplant 7. history of active autoimmune disease 8. history of deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months before enrollment 9. recent history of other (non multiple myeloma) cancer 10. active viral, fungal, bacterial or other infection note: other protocol defined inclusion/exclusion criteria may apply
pilot study of internet-based cognitive behavior therapy for fibromyalgia

Conditions: Fibromyalgia

Summary: this pilot trial will include 30-40 participants with a diagnosis of fibromyalgia. the purpose of the study is to evaluate an internet-based treatment protocol based on cognitive behavioral therapeutic principles. participants are required to have a previous diagnosis of fibromyalgia before entering into the trial. the treatment will be 10 weeks long and all included participants will be given treatment, i.e. there is no randomization to a comparison group.


Eligibility criteria:
inclusion criteria: * current diagnosis of fibromyalgia exclusion criteria: * current diagnosis of severe psychiatric disorder
pioglitazone in psoriasis- a clinical and molecular study.

Conditions: Psoriasis

Summary: the study will assess the effectiveness of pioglitazone on cellular and clinical levels in terms of improvement of both skin and systemic manifestations of psoriasis. the investigators assume that pioglitazone (one of thiazolidinediones readily available in egypt), can regulate keratinocytes' disordered proliferation observed in psoriasis, in addition to improving the insulin resistance in peripheral tissues observed in many psoriatic patients and causing metabolic syndrome. this will allow to give a safer therapy than the available ones for psoriasis and to treat the patient in a more global perspective.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years and less than 65 years. * plaque psoriasis vulgaris ≥ 10% (apart from palmoplantar psoriasis which will be included). exclusion criteria: * age less than 18 years and more than 65 years * mild psoriasis less than 10% body surface area * erythrodermic or pustular psoriasis * liver disease, cardiac disease (suspected from history or ecg), or any other major medical disorder detected by history. * pregnant and lactating females.

Keywords: psoriasis insulin resistance metabolic syndrome pioglitazone randomized control trial
flash glucose measure system and continuous subcutaneous insulin infusion therapy in poorly controlled diabetes type 1 patients

Conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus); Diabetes Mellitus, Type 1

Summary: patients with diabetes type 1 with poor glycemic control will be switched to insulin pump and fgm system (flash glucose monitoring) during 6 months, correlated to the hypothesis that they could benefit from this intervention by being reengaged in diabetes self-management.

this is a non-controlled proof of concept prospective pilot study in adults with type 1 diabetes, hba1c \>9% (75 mmol/mol), multi daily insulin injections ( mdi) and who perform less than 2 smbg /day. patients will be switched to insulin pump and started a fgm system (free style libre®) during 6 months, hoping this intervention can reengage patients in self-management, reduce hba1c without increasing the risk of ketoacidocetosis (dka) and severe hypoglycemia (sh), and keep the dtsq (diabetes treatment satisfaction questionnaire) and hfs (hypoglycemia fear scale) at good levels.

Eligibility criteria:
inclusion criteria: * adults with type 1 diabetes, aged between 18 and 55, hba1c \>9% (75 mmol/mol), multi daily insulin injections (mdi) treatment, maximum 2 smbg /day exclusion criteria: * diabetes with less than 1 year duration, severe active retinopathy requiring laser therapy, severe psychiatric illness, pregnancy, inability to communicate in french, concomitant severe active disease, patients already using a fgm or a cgm

Keywords: diabetes type 1 insulin pump flash glucose monitoring hypoglycemia ketoacidocetosis dtsq hfs
iron therpay and fatigue in women of reprodcutive age

Conditions: Fatigue Syndrome, Chronic; Fatigue

Summary: for the assessment of anemia and then assessment of fatigue levels in non-anemic women followed by assessment of iron levels and intervention of iron and placebo


Eligibility criteria:
inclusion criteria: reproductive age non-anemic fatigued exclusion criteria: anemiac males

Keywords: fatigue
release of proinflammatory cytokines (il-1β, il-6) and total-prostaglandin (pg) following femtosecond laser-assisted cataract surgery compared to manual cataract surgery

Conditions: Age Related Cataracts

Summary: patients with bilateral age related cataract will be included in the study. manual cataract surgery (mcs) will be performed in one eye and laser cataract surgery (lcs) in the corresponding eye. lcs will be performed with an approved femtosecond laser (fsl) device with an integrated imaging system. after surgery aqueous humour will be collected and screened with enzyme-linked immunosorbent assay (elisa) kits for interleukin-1β; interleukin-6 and pg.


Eligibility criteria:
inclusion criteria: * bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation. * pupil dilation of ≥ 6.5mm * age 40 and older exclusion criteria: * corneal abnormality * pseudoexfoliation * preceding ocular surgery or trauma * uncontrolled glaucoma * proliferative diabetic retinopathy * iris neovascularization * history of uveitis/iritis * microphthalmus * recurrent intraocular inflammation of unknown etiology * blind fellow eye * uncontrolled systemic or ocular disease * pregnancy * lactation

Keywords: laser cataract surgery prostaglandin
a pilot phase 2 trial of the immunogenicity, and safety of gi-4000; an inactivated recombinant s. cerevisiae expressing mutant ras protein, as consolidation therapy following curative treatment for stage i-iii non-small cell lung cancer (nsclc) with tumor sequence confirmation of k-ras mutation

Conditions: NSCLC

Summary: this is a consolidation therapy trial evaluating gi-4000 in subjects with nsclc treated with curative intent who are disease free at their first post-treatment restaging assessment.

nsclc is the deadliest form of human cancer, killing approximately 150,000 people a year in the united states. the best treatment for nsclc is surgical resection. for patients with inoperable or unresectable nsclc chemotherapy and radiation is used as first line therapy. this is a consolidation therapy trial evaluating gi-4000 in subjects with nsclc treated with curative intent who are disease free at their first post-treatment restaging assessment. these subjects must also have a ras mutation.

Eligibility criteria:
inclusion criteria: * pathologically proven stage i-iii nsclc * confirmed product related ras mutation * ecog performance status of less than or equal to 2 * greater than or equal to 18 years of age exclusion criteria: * history of a previous cancer * history of splenectomy * history of crohns disease or ulcerative colitis * history of major organ transplantation * concurrent or chronic steroid therapy * history of allergy to yeast * presence of an unstable or poorly controlled medical condition * pregnant or nursing mothers * positive skin test to yeast

Keywords: nsclc cancer immunotherapy
longitudinal twin study - cohort study of blood pressure

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to analyze the genetic and environmental contributions of juvenile hemodynamic determinants of blood pressure, including cardiac output and systemic vascular pressure, to adult cardiovascular risk.

background: identifying individuals at a young age who are at risk for future development of hypertension in adult life is a public health issue of great importance. the imperfect nature of blood pressure tracking throughout childhood and adolescence, and the fact that the genes which determine blood pressure in childhood may not be the same ones which operate in adulthood make it clear that improved predicting models are needed. the twin-parent study design allowed testing more subtle genetic and environmental hypotheses than was possible with nuclear families or twins alone. the longitudinal component permitted an analysis of developmental changes in the genetic expression of the hemodynamic determinants of blood pressure. the inclusion of unlike sex twins permitted an analysis of the consistency of genetic and environmental effects across the sexes. design narrative: the longitudinal comparison of the cardiovascular responses of adolescent twins and their parents was initialed in 1983. three cohorts of twin families were enrolled, each cohort beginning 18 months apart. both monozygotic and dizygotic twins were included. variables measured included demographics, family history, personality, blood pressure, anthropometry, stage of puberty, dynamic exercise, isometric exercise, psychological stress, echocardiography, genotyping, and lipid profiles. each cohort revisited every 18 months. a fourth cohort of 330 preadolescent twin pairs stratified by sex and zygosity was recruited from an established population-based twin registry. the hemodynamic determinants of blood pressure were assessed by non-invasive measurements of cardiac function including echocardiography and response to isometric and dynamic exercise. zygosity was determined by questionnaire and confirmed by dermatoglyphic analysis and blood group tests. anthropometric and hemodynamic measurements in the parents were compared to those in the children. the study included up to five sets of longitudinal measurements, thereby permitting an evaluation of whether the same or different genes operated at different ages encompassing pre-puberty, puberty, and post-puberty.

Eligibility criteria:
no eligibility criteria
sox regimen as neoadjuvant chemotherapy for ajcc stage ii-iii gastric cancer

Conditions: Gastric Adenocarcinoma

Summary: this is a randomized, multicenter, controlled trial to prove efficacy of s-1 and oxaliplatin as neoadjuvant chemotherapy for advanced gastric cancer patients who undergo d2 gastrectomy. the primary endpoint is three-year free disease and the second primary includes five-year overall survival, safety and r0 resection rate.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed gastric adenocarcinoma 2. gastroesophageal junction tumour type ii or iii(nccn 2009) can be enrolled 3. all patients must undergo eus,ct(or pet-ct) and laparoscopy to evaluate tumor stage classification (tnm), and only stage ii or iii (ajcc 7th) gastric cancer patients can be enrolled 4. planning to undergo gastric cancer d2 surgery after neoadjuvant chemotherapy 5. kps \> 60; ecog performance status 0-2 6. life expectancy \> 6 months 7. age: 20 to 75 years 8. no other severe disease and life expectancy less than five years 9. 7 days before enrolled, baseline data should be finished including: * granulocyte count ≥ 1.5×109/l; * platelet count ≥ 100×109/l; * hemoglobin ≥ 90g/l; * hepatic \< 1.5×uln; * total bilirubin ≤ 1.0×uln; * creatinine \< 1.5×uln; * pt-inr/ptt \< 1.7× uln 10. disease had to be measurable by the response evaluation criteria in solid tumors (recist1.1) criteria 11. written informed consent and able to comply with the protocol exclusion criteria: 1. patient cannot undergo surgery or chemotherapy because of other severe disease 2. be allergic to chemotherapy drugs 3. patients receiving any chemotherapy or drugs involved in this trial in four weeks before enrolled 4. patients received cytotoxic chemotherapy, targeted therapy, immunotherapy or radiotherapy for gastric cancer 5. within the last 5 years in patients with a history of other malignant diseases 6. pregnant or breast-feeding women 7. severe heart disease like symptoms of coronary heart disease, new york heart association (nyha) grade ii or worse congestive heart failure or cardiac arrhythmia having medications or myocardial infarction within the last 12 months 8. patients with upper gastrointestinal obstruction or absorption anomaly; patient in obstruction of the helicobacter pylori failure like effect s-1 to take and absorb 9. patients with a history of peripheral nerve disease 10. patients who get organ transplant 11. lack of dihydropyrimidine dehydrogenase (dpd) 12. infection or other disease failure to control

Keywords: two arms d2 lymphadenectomy chemotherapy before and after surgery disease free survival
lc-plasma on immune response and reducing symptoms of upper respiratory infectious diseases

Conditions: Healthy Volunteer; Immune Response

Summary: the goal of this study is to evaluate the effects of lc-plasma on the innate and acquired immune systems, including the activation of pdcs, which play a role in virus elimination, as well as to assess its efficacy in reducing clinical symptoms of upper respiratory infectious diseases in healthy adults. researchers will compare lc-plasma to placebo, participants will take a tablet containing lc-plasma or placebo daily for 4 weeks.


Eligibility criteria:
inclusion criteria: * individuals who can provide a signed and dated informed consent form after confirming their willingness to participate. * individuals willing to comply with all study procedures during the study period, including daily monitoring record compliance, cooperating with blood and urine sample collection and performing regular rats. * healthy people living in australia aged 18-60 (both men and women). * individuals who have received at least two doses of a sars-cov-2 vaccine, with at least two weeks having passed since the last dose. * individuals who are not currently infected with sars-cov-2 and, if previously infected, have recovered and have been infection-free for at least four weeks. * individuals who do not have any chronic or acute illnesses, including respiratory and/or gastrointestinal and/or other diseases, (e.g. hypertension, ibs, ibd, sle, cancer, asthma, primary or secondary immunodeficiencies etc.), at the time of enrolment. exclusion criteria: * individuals medically prescribed medications that would affect the immune and/or the inflammatory response. * individuals deemed unsuitable for participation by griffith ctu staff and/or the study clinician. * active smokers/vapers and/or individuals with nicotine or drug habits. * individuals currently participating in (or planning to participate in) other clinical trials. * women who are pregnant, planning to become pregnant during the study period, or are currently breastfeeding. * individuals unable to abstain from alcohol for two days prior to blood and urine sample collection. * individuals unable to refrain from consuming other lactic acid bacteria supplements. * individuals who are known to be hiv, htlv-1, or hcv positive (based on answers to the enrolment questionnaire).

Keywords: lc-plasma healthy volunteer