Kornimate/medical-research-clean huggingface dataset:
phase 3 study of ebi-005 in dry eye disease

Conditions: Dry Eye Disease (DED)

Summary: this is a phase iii double-masked, randomized, controlled study evaluating the efficacy of ebi-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe ded three times daily for 12 weeks. approximately 730 subjects at up to approximately 50 centers in the united states will be screened, enrolled into the study.


Eligibility criteria:
inclusion criteria: * give written informed consent and any authorizations required by local law (e.g., protected health information waiver) prior to performing any study procedures; * are ≥ 18 years of age; * are willing and able to follow instructions and can be present for the required study visits for the duration of the study; * have a history of dry eye disease (ded) in both eyes supported by a previous clinical diagnosis * have normal lid anatomy. * if female and of child bearing potential, she must not be not pregnant or lactating and not sexually active (abstinent) within 14 days prior to visit 1 exclusion criteria: * have signs of infection (i.e., fever or current treatment with antibiotics) * have been exposed to an investigational drug/device within the preceding 30 days * be an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same * be unwilling to or unable to comply with the study
mifepristone and misoprostol versus misoprostol alone for missed abortion: a randomized-controlled trial

Conditions: Missed Abortion; Pregnancy

Summary: the purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.

the primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of missed abortion. this will be a randomized controlled double-blinded trial of 416 women comparing misoprostol alone to mifepristone plus misoprostol for treatment of missed abortion less than 13 weeks+ 0 days lmp. all women in the trial will undergo routine screening (including ultrasound) and pre-medical induction care per standard practice at the hospital. all eligible women agreeing to participate in the study will be randomized to receive one of the following regimens: 1) study group one: 200mg mifepristone followed in 24 hours by 800mcg sublingual misoprostol; 2) study group two: placebo followed in 24 hours by 800mcg sublingual misoprostol.

Eligibility criteria:
inclusion criteria: * ultrasound examination demonstrating: 1. evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) or 2. empty gestational sac with no evidence of incomplete abortion or growth over a 7-day period confirmed by two ultrasounds performed one week apart. * if fetus exists, fetal size less than 12 weeks+6 days * closed cervical os * eligible to consent for research according to local regulations exclusion criteria: * active bleeding at enrollment and/or history of bleeding within the prior week * allergies or other contraindications to the use of mifepristone or misoprostol * suspected ectopic pregnancy * history of trophoblastic disease * coagulation disorder and/or currently taking anticoagulants * any serious medical condition

Keywords: mifepristone misoprostol obstetrics reproductive health pregnancy abortion missed abortion
study to evaluate t(11;14) status and bcl2 expression in adult participants with multiple myeloma (mm)

Conditions: Multiple Myeloma (MM)

Summary: multiple myeloma (mm) is a rare cancer caused by abnormal survival of plasma cells (blood cells). most trial participants with mm relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. this is a study to assess t(11;14) and bcl2 expression in adult participants with newly diagnosed and relapsed/refractory (r/r) mm. approximately 500 adult participants with newly confirmed or relapsed/refractory (r/r) multiple myeloma (mm) will be enrolled in around 15-20 countries. participants will receive standard of care while participating in this study. no drug will be administered as a part of this study. participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide bone marrow and blood samples.


Eligibility criteria:
inclusion criteria: - confirmed newly diagnosed or relapsed/refractory (r/r) multiple myeloma (mm) who have signed informed consent for the use of their biological material for research purposes. exclusion criteria: - participants who do not have bone marrow (bm) and blood sample at time of diagnosis or at confirmation of relapse.

Keywords: multiple myeloma (mm) relapsed/refractory (r/r) multiple myeloma (mm) t(11 14) bcl2
performance study of sona saliva c-19 rapid test

Conditions: Covid19; Sars-CoV-2 Infection; Corona Virus Infection

Summary: the sona saliva c-19 rapid test is a bioassay intended for rapid point-of-care detection of the sars-cov-2 virus. performance of the sona saliva c-19 rapid test assay will be assessed by comparison to a rt-pcr reference method

the clinical performance of the sona saliva c-19 rapid test will be evaluated in a prospective clinical study conducted at a single (1) investigational site in toronto, cananda. consenting patients of ages 18+, any gender, or race/ethnicity who presents at the test site with covid-19 like symptoms during the 2021 covid-19 season will be asked to take part in the study, will be sequentially enrolled and tested. trained operators with laboratory experience who have received training on the use of the sona saliva c-19 rapid test will conduct the testing and represent the intended users. a subject's participation in this study will consist of a single visit. following the completion of the informed consent process, study questionnaire and a review of inclusion/exclusion criteria to determine eligibility, each subject will receive a unique study identification number, be asked to provide a sample for testing.

Eligibility criteria:
inclusion criteria: up to 500 subjects will be screened, consented, and enrolled to obtain a minimum of 50 eligible candidates. in order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. presenting to the emergency department at hrh. 2. receiving a covid-19 rt-pcr test as per standard pathway of care. 3. provide written informed consent. 4. patients must be presenting or have experienced at least one (1) or more signs or symptoms of covid-19 within ≤ 7 days: 1. fever as self-described or measured ≥ 38 °c (100.4°f) 2. chills 3. cough 4. shortness of breath 5. congestion or runny nose 6. difficulty breathing 7. muscle or body aches 8. vomiting 9. diarrhea 10. new loss of sense of taste or smell 11. headache 12. general malaise 13. sore throat exclusion criteria: 1. asymptomatic patients. 2. patients unable to provide a saliva sample. 3. patients unable to give consent. 4. patients who will not be receiving a nasopharyngeal rt-pcr test.

Keywords: antigen covid19 rapid test saliva
oxytocin administration during cesarean section

Conditions: Postpartum Hemorrhage

Summary: cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the uterine wall. this definition does not include removal of the fetus from the abdominal cavity in the case of uterine rupture or in the case of an abdominal pregnancy the guidelines of the royal college of obstetricians and gynaecologists on caesarean section recommend a slow intravenous bolus dose of 5 iu of oxytocin after delivery of the infant. intravenous oxytocin has a short half life (4-10 minutes); therefore the potential advantage of an oxytocin infusion at caesarean section is in maintaining uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhage occurs


Eligibility criteria:
inclusion criteria: * primigravida or multigravida * term (37 - 42 weeks), * singleton pregnancies * booked for elective caesarean section. * accepting to participate in the study. exclusion criteria: * • medical disorders involving the heart, liver, kidney or brain. * diabetes mellitus and hypertension. * blood disorders (e.g. coagulopathies, thrombocytopenia) * patients requiring blood transfusion due to anemia. * risk factors for uterine atony e.g. macrosomia, polyhydramnios and multiple pregnancy. * previous 2 or more cesarean section * placenta previa or placental abruption * previous major obstetric haemorrhage (\>1000 ml) in previous deliveries. * known fibroid or adenomyosis. * women who received anticoagulant therapy. * severe preeclampsis. * uterine anomalies.
acupuncture for pain control after ambulatory knee arthroscopy

Conditions: Postoperative Pain; Knee Arthroscopy; Acupuncture

Summary: aim of the study: to investigate whether acupuncture with indwelling fixed needles reduces pain and analgesic requirement and foster mobilization in patients after arthroscopic knee surgery (aks) design: prospective pilot investigation with non-randomized arm number of patients: n = 60 (30 patients with acupuncture additional to standard pain treatment (spt) vs. 30 patients with spt only inclusion criteria: adult patients scheduled to elective aks in general anaesthesia with \< 80 min. duration without previous opioid and psychotropic medication given informed consentoutcome measures: postoperative analgesic requirement; pain intensity; incidence of side effects; physiological parameters; mobilization score


Eligibility criteria:
inclusion criteria: 1. patients with an american society of anesthesiologists physical status of i to ii scheduled for elective ambulatory arthroscopic knee surgery under standardized general anesthesia 2. surgery time does not exceed 80 minutes 3. patients without previous opioid and psychotropic medication 4. patients aged between 19 and 55 years, able to fill in the study questionnaire (appendix f) 5. patients who have given written informed consent exclusion criteria: 1. current psychiatric disease 2. local skin infection at the sites of acupuncture 3. aged \ 55 years 4. failure to follow the standardized schema of general anaesthesia 5. surgery time more than 80 minutes 6. intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines) 7. patients who consumed opioid medication at least 6 months before surgery 8. patients who are unable to understand the consent form or to fill in the study questionnaire.
health related quality of life after video assisted thoracoscopic lobectomy for lung cancer

Conditions: Operable Early Stage NSCLC by the VATS Approach

Summary: to test the effect of post operative complications on the health related quality of life (hrqol) after video assisted thoracoscopic surgery (vats) for non-small cell lung cancer (nsclc). the hrqol of patients with early stage nsclc will be assessed at baseline (before surgery) using 3 different reliable and valid hrqol questionnaire (sf-36, eq-5d and qlq30/13), then at regular intervals in the early post-operative period (2,4,8 and 12 weeks) the hrqol will be assessed using the same questionnaires to determine the difference between patients with low/no post operative complications to those with high grade post-operative complications. post operative complications will be assess while the patients in the hospital on a daily basis using the clavien classification system for surgical complications.


Eligibility criteria:
inclusion criteria: * adults (more than 18 years) * early stage nsclc * speak english * no hearing/speaking difficulties * able to walk without assistance * surgery via the vats approach exclusion criteria: * less than 18 years old * metastatic disease to the lung * benign lung disease * advanced nsclc * small cell lung cancer * non english speakers * walking/hearing/speaking difficulties
unloading in heart failure cardiogenic shock

Conditions: Cardiogenic Shock

Summary: the purpose of this research study is to evaluate whether timely and aggressive temporary mechanical circulatory support (tmcs) through the impella 5.5® in patients with acute decompensated heart failure complicated by cardiogenic shock (adhf-cs) has the potential to reduce the hf-cs related clinical events compared to the current standard of care.

to demonstrate the efficacy of timely temporary mechanical left ventricular unloading with the impella 5.5® assist device in patients with acute decompensated heart failure complicated by cardiogenic shock (adhf-cs) vs. current standard of (pharmacological) care

Eligibility criteria:
inclusion criteria: 1. evidence of hfref according to esc hf guidelines (lvef ≤ 35%) 2. signs of (persistent) congestion (elevated cvp, edema, rales, ascites, pleural effusion) 3. evidence of cs with presence of at least 2 of the 3 following: 1. hypotension 1. systolic blood pressure \<90 mmhg for at least 30 min or 2. mean arterial pressure \<60 mmhg for at least 30 min 2. hypoperfusion 1. lactate \> 2.0 mmol/l (two consecutive values \> 2 mmol/l with at least 30 min between samples, with non-decreasing trend on if on (steady doses of) inotropes and/or vasopressors) 2. amino-l-transferase \>200 u/l (two consecutive values \> 200 ul/l with at least 30 min between samples, with non-decreasing trend if on (steady doses of) inotropes and/or vasopressors) 3. creatinine rise ≥ 0.3 mg/dl/24h ( 26,53 μmol/l) 4. oliguria (≤ 0,5 ml/kg/h, ≤ 720 ml/24 h) 3. inotropes/vasoactives (use of) exclusion criteria: 1. contraindications for impella 5.5 2. severe concomitant rv failure 3. grade iv mitral regurgitation eligible for surgical treatment 4. dialysis for end-stage renal failure 5. acute coronary syndrome (type 1, ami) 6. bradycardia and av blocks necessitating pacemaker implantation 7. hd parameters and biochemistry alterations as specifically defined for scai cs e 8. combined cardiorespiratory failure 9. resuscitated (ohca/pea) 10. history of cva or tia within previous 90 days 11. history of acute myocardial infarction within previous 30 days 12. history of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent gu or gi bleed, or will refuse blood transfusions 13. inflammatory 14. active systemic infections 15. acute myocarditis

Keywords: unloading acute decompensated heart failure cardiogenic shock temporary mechanical circulatory support (tmcs) inotropes
ketamine for treatment-resistant depression: a multicentric clinical trial in mexican population

Conditions: Depressive Disorder,; Treatment-Resistant Depression

Summary: a randomized multicentric parallel arms study involving the use of ketamine for treatment-resistant depression will be held at three national health provider clinics in the mexican population. the purpose of this study is to determine whether clinical response seen in previous studies is replicable in this population.


Eligibility criteria:
inclusion criteria: * age: 18-65 years old * mayor depressive disorder diagnosis based on dsm-iv tr. * classification of mdd as treatment-resistant. * no brain structural abnormalities as evidenced by an mri scan. * signed acceptance of informed consent. exclusion criteria: * other psychiatric diagnosis apart from mdd. * substance abuse or dependence (prior or during study). * pregnancy. * congestive heart disease. * personal history of psychosis. * first-degree relative with history of psychosis. * glaucoma. * present neurological disease. * high blood or pulmonary artery pressure. * declining the signing of the informed consent.

Keywords: ketamine depression depressive disorder
a randomized, double-blind, placebo-controlled evaluation of increasing doses of weekly tafenoquine for chemosuppression of plasmodium falciparum

Conditions: Malaria

Summary: this was a randomised, double-blind, placebo-controlled study to compare the efficacy of a range four weekly doses of tafenoquine, and weekly mefloquine, with placebo as chemosuppression of p. falciparum malaria. medications and placebo were matched and a double-dummy technique enabled blinding of tafenoquine versus mefloquine.


Eligibility criteria:
inclusion criteria: * willing subjects in good general health. * males aged 18 to 60; females aged 50 to 60. * subjects who planned to stay in the study area until the end of the study. exclusion criteria: * subjects with any cardiovascular, liver, neurologic, or renal function abnormality which, in the opinion of the clinical investigators, would have placed them at increased risk of an adverse event or confused the result. * subjects with a personal or family history of seizures or frank psychiatric disorder. * females who had not ceased menstruation; a urine β-human chorionic gonadotrophin (β-hcg) test was to be performed at screening females who had ceased menstruation to exclude pregnancy as a cause. * females who were lactating. * subjects given antimalarial drugs for treatment within two weeks of study drug initiation. * subjects with clinically significant abnormalities (to include but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistry and haematology values. * subjects with known hypersensitivity to any of the study drugs. * subjects unwilling to remain in the area, report for drug administration or blood drawing during the 3-4 month duration of the study. * subjects with g6pd deficiency (as determined by two separate qualitative tests per subject administered using distinct methods; methods used were visual dye and filter paper methods). * subjects with any of the following laboratory values: haemoglobin (hb) \ 1.5mg/dl, alanine transaminase (alt) \>60iu or 1+ haematuria as detected by urine dipstick.
sequential targeting of cluster of differentiation 52 (cd52) and tumor necrosis factor (tnf) allows early minimization therapy in kidney transplantation

Conditions: Kidney Transplantation

Summary: the aim of the study is to evaluate the efficacy of new immunosuppressive protocol based on two applications of anti-cd52 mabcampath (alemtuzumab) a single dose of anti-tnf-α remicade (infliximab) monoclonal antibodies in the early posttransplant period followed by either monotherapy based on tacrolimus or sirolimus.


Eligibility criteria:
inclusion criteria: * first deceased-donor kidney transplantation * age \>18 years * donor \<65 years * cytomegalovirus (cmv)/ epstein-barr virus (ebv) seropositivity * panel reactive antibodies (pra) \<10% * written consent exclusion criteria: * retransplantation, combined transplantation * prior immunosuppression less than 6 months prior transplantation * induction therapy with antibodies * leukopenia \< 4000, thrombocytopenia \< 100 000, haemoglobin \< 80 g/l * history of antithymoglobulin (atg) or anti-cluster of differentiation 3 (cd3) monoclonals or anti-tnf-α * tuberculosis history * anti-hepatitis c virus (hcv) positivity, hbsag * hiv positivity * malignancy history * allergy to study medication * fertile women without contraception * pregnancy, breastfeeding mothers
surgical study comparing 2 procedures for the treatment of a dropped bladder

Conditions: Prolapse

Summary: the purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.

it is not known whether anterior vaginal repair (colporrhaphy) or abdominal paravaginal defect repair is the procedure of choice for the treatment anterior vaginal wall prolapse. this randomized prospective study will attempt to answer this question by assessing the change in the stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates. patients enrolled into the study will be followed up for up to 2 years after surgery.

Eligibility criteria:
inclusion criteria: * women over the age of 18 seen at the urogynecology clinic at geisinger with primary or recurrent pelvic organ prolapse including an anterior vaginal wall relaxation with or without urinary incontinence who are scheduled to have pelvic reconstructive surgery will be eligible to participate in the trial. exclusion criteria: * patients with at least 2 previous prolapse surgeries * patients who are pregnant or planning to have a pregnancy

Keywords: cystocele, prolapse, anterior repair, colporrhaphy
the effect of coenzyme q10 in preventing pain after thoracoscopic surgery

Conditions: Postoperative Pain

Summary: this study aimed to assess the effectiveness of coenzyme q10 in preventing both acute and chronic pain following thoracoscopic surgery, with a focus on its potential benefits in reducing the incidence and severity of pain.


Eligibility criteria:
inclusion criteria: * aged 18-75 years; * american society of anesthesiology (asa) physical status classification i-iii; * scheduled for elective lung resection surgery under thoracoscopy; * voluntarily opting for patient-controlled intravenous analgesia; * willing to participate in this trial after consultation with the patient or their family and signing the informed consent form. exclusion criteria: * history of previous thoracotomy or thoracoscopic surgery; * patients converted to open thoracotomy intraoperatively; * severe hepatic or renal dysfunction; * history of substance abuse; * pregnancy or breastfeeding; * history of chronic pain; * use of coenzyme q10 for more than one month; * allergy to coenzyme q10; * patients unable to communicate or cooperate.