Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of lumiracoxib 400 mg in arthroscopic knee surgery

Conditions: Pain

Summary: this study is designed to investigate the efficacy and safety of a single daily dose of 400 mg lumiracoxib given pre-emptively versus post-operatively in terms of efficacy in reducing pain associated with ambulatory arthroscopic knee surgery


Eligibility criteria:
inclusion criteria: * patients who need scheduled minor ambulatory arthroscopic knee surgery. exclusion criteria: * patients with any surgical or medical conditions which could place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: arthroscopic knee surgery cyclooxygenase-2 inhibitors lumiracoxib cox189 ambulatory arthroscopic knee surgery
percutaneous imaging-guided cryoblation of the anterior abdominal wall endometriosis scars

Conditions: Endometriosis

Summary: endometriosis is a common condition affecting 10% of women. it is characterized by the presence of ectopic endometrial cells. this pathology most frequently develops in the ovaries, utero-sacral ligaments and pelvic peritoneum, but also in the recto-sigmoid. rarely, these lesions are found outside the pelvis, and even more exceptionally in the abdominal wall (in 0.03 to 1% of cases). cryotherapy has already been used for many years to treat soft tissue tumors (kidney and prostate tumors). it has also been successfully used by interventional radiologists to treat parietal desmoid tumors. after discussions with radiologists, given the similarity of location and extension of wall endometriosis lesions with desmoid tumours, the successes observed, and the scarcity of studies in the literature, it seemed appropriate to the investigators to study this new therapy. the aim of this study was to investigate the efficacy of cryotherapy on parietal endometriosis lesions.


Eligibility criteria:
inclusion criteria: * adult woman (≥18 years old) having benefited from cryotherapy of an abdominal wall endometriosis nodule between january 6, 2020 and january 2, 2023. * subject not objecting to the reuse of their data for the purposes of this research exclusion criteria: * subject having expressed its opposition to the reuse of its data for scientific research purposes.

Keywords: endometriosis endometrial cells radiofrequency anterior abdominal cryotherapy
a/lci-oct pilot in esophagus

Conditions: Barrett Esophagus

Summary: this study will test a newly developed dual modality probe, including optical coherence tomography (oct) and angle-resolved low-coherence interferometry (a/lci), in the human esophagus to determine 1) whether adequate tissue contact can be attained by the probe to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or barrett's esophagus (be) epithelium. this pilot study will test the operating characteristics of the probe and collect data for further optimization of the a/lci-oct device.


Eligibility criteria:
inclusion criteria: * presenting to university of north carolina (unc) for routine care upper endoscopy * meet one of the following criteria: 1. current dysplastic or non-dysplastic barrett's esophagus of any length or, 2. history of dysplastic or non-dysplastic barrett's esophagus after treatment with endoscopic eradication therapy (eet) or, 3. normal asymptomatic controls without any history of dysplastic barrett's esophagus * aged 18 to 80 * able to read, comprehend, and understand the informed consent document exclusion criteria: * prior esophageal surgery (uncomplicated nissen fundoplication ok) * pregnant women * unable to provide written informed consent
post-resuscitation interdisciplinary consultation system: a randomized, multicenter, interventional study to assess quality of life after a stay in the copréa intensive care unit

Conditions: Post Intensive Care Syndrome

Summary: a patient's stay in the icu is not without consequences and can cause various physical and/or psychological sequelae such as anxiety, depression, post-traumatic stress disorder (ptsd), physical weakness and memory problems. these sequelae are grouped under the name "post intensive care syndrome" or pics. numerous studies have shown that pics affects 50-70% of patients; however, very few studies have been conducted on the medical and psychological support devices needed for these patients following their hospitalization. despite recommendations to set up an early and specific rehabilitation program, post-resuscitation consultations are not very frequent in france. the aim of the study is to measure the impact of an interdisciplinary post-resuscitation consultation on the quality of life of patients who have stayed more than 6 days in an intensive care unit. all patients who agreed to participate will be followed for a period of 9 months after discharge from the icu. one month after discharge from the icu, the patients will be randomly assigned to * either in the "intervention" group who will benefit from an interdisciplinary post resuscitation consultation 4/5 months after their discharge from the intensive care unit * or in the "control" group without post resuscitation consultation. they will all be contacted at 4/5 and 9 months to complete psychological and quality of life questionnaires.


Eligibility criteria:
inclusion criteria: * person who has given oral consent * patient 18 years of age or older * patient with at least one organ failure * patient with a stay of 6 days or more exclusion criteria: * person who is not affiliated or not a beneficiary of a social security system * patient at the end of his/her life * patient who does not speak french * minor (\< 18 years old) * person subject to a legal protection measure (curatorship, guardianship) * person subject to a legal protection measure * pregnant, parturient or breastfeeding women * patient incarcerated * patient with a psychiatric history
edmonton obesity staging system: post-operative outcome and 30-day mortality

Conditions: Postoperative Complications; Other Complications of Other Bariatric Procedure

Summary: the edmonton obesity staging system (eoss) is a more comprehensive measure of obesity-related diseases and predictor of mortality than bmi or waist circumference. the aim of this study is to determine whether the eoss is also important in predicting post - operative outcome and 30-day mortality after metabolic surgery.

from october 2014 to december 2015 the investigators conducted a prospective data collection on patients undergoing either laparoscopic sleeve gastrectomy (lsg) or laparoscopic gastric bypass (laparoscopic roux-en-y-gastric bypass (lrygb) and omega-loop-gastric-bypass (lolgb)), being the first surgical treatment for severe obesity. preoperative eoss by sharma et al. was applied to all patients by two different evaluators. data collection included the following: gender, age, body mass index, waist circumference, waist to hip ratio, comorbidities, early - postoperative complications, readmission rates and 30 - day mortality. follow-up was performed in all patients up to 1 month after surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing either lsg or lrygb, being the first surgical treatment for severe obesity exclusion criteria: * bariatric surgery in the anamnesis

Keywords: eoss metabolic surgery postoperative outcome 30 - day mortality
a single group study to evaluate the efficacy of a cosmetic product line on acne symptoms

Conditions: Acne

Summary: this twelve-week trial will examine the effectiveness of a menning labs eq product line acne product. participants will use the exfoliating cleanser, cream, and gel daily for 8 weeks. participants will complete questionnaires at baseline, day 1, day 3, day 7, day 28, day 42, and day 56. participants will also provide before-and-after photos at baseline, day 7, and day 42, as well as undergo expert skin grading at baseline and day 42. the questionnaire on day 56 will mark the conclusion of the trial.


Eligibility criteria:
inclusion criteria: * be aged between 18-45. * anyone who has acne prone skin and a history of recurring acne. * has visible acne at enrollment. * anyone who is generally healthy - does not live with any uncontrolled chronic disease. * have a digital camera or smartphone to take photos of the face. exclusion criteria: * anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders. * anyone currently using a prescription skin product. * anyone who is unwilling to stop using the current acne supplements they are taking. * anyone with known severe allergic reactions. * any women who are pregnant, breastfeeding or attempting to become pregnant. * anyone unwilling to follow the study protocol. * anyone who identifies as having sensitive skin.
treatment of refractory infantile spasms with fenfluramine

Conditions: Infantile Spasm

Summary: this is a phase ii clinical trial in which children with refractory infantile spasms (also called epileptic spasms or west syndrome) will be treated with fenfluramine, to evaluate efficacy, safety, and tolerability. patients with infantile spasms that have not responded to treatment with vigabatrin and acth we will be invited to participate. study participants will undergo baseline video-eeg, receive treatment with fenfluramine for 21 days, and then undergo repeat video-eeg to determine effectiveness. patients with favorable response will have the opportunity to continue treatment for up to 6 months.


Eligibility criteria:
inclusion criteria: * children ages 12 to 36 months, inclusive * clinical diagnosis of infantile spasms * continued epileptic spasms despite adequate treatment with acth and vigabatrin. exclusion criteria: * significant preexisting cardiovascular disease * exposure to any cannabinoid product within 14 days of screening * initiation or dose-titration of any second-line treatment for infantile spasms in the 14 days prior to screening. * implantation of a vagal nerve simulator within 14 days of screening * initiation and maintenance of the ketogenic diet within 3 months of screening
fdg (fluorodeoxyglucose) findings after covid-19 vaccination

Conditions: Vaccine Reaction; Oncology

Summary: it is important to evaluate the vaccine-related metabolic changes on fdg pet/ct to avoid confusing results. the investigators aimed to assess the frequency and intensity of regional and systemic metabolic pet/ct changes of patients who received the mrna-based covid-19 vaccine (bnt162b2-pfizer/biontech) and to analyze possible factors affecting these changes.


Eligibility criteria:
inclusion criteria: * patients referred for post-vaccination fdg pet/ct imaging exclusion criteria: * disseminated metastatic disease, ipsilateral breast cancer or lymphoma that was likely to involve axilla, and patients who had ipsilateral intense axillary uptake or thyroiditis on their prior imaging, were exclusion criteria

Keywords: covid-19 vaccine pet/ct fdg mrna
preeclampsia and nonsteroidal drugs for analgesia: a randomized non inferiority trial

Conditions: Preeclampsia Severe; Preeclampsia Postpartum

Summary: a randomized non-inferiority trial of women with preeclampsia with severe features to determine if the addition of nonsteroidal anti-inflammatory drugs is inferior or non-inferior to standard analgesic bundles in their impact on postpartum hypertension.

recently published clinical guidelines for the care of women with hypertensive disorders recommended that nonsteroidal anti-inflammatory drugs (nsaids) should be withheld from patients with hypertension that persists for more than one day postpartum (1). this recommendation is based in data from the general medicine literature, which suggests a role of nsaids in precipitating hypertension in non-pregnant adults (2,3). it may also draw from previously published case reports of post-partum hypertension that were thought to be nsaid induced (4). there has been a paucity of data from the obstetric literature to support or rebuff this recommendation. as the opioid crisis worsens in the united states, additional attention and resources have focused on limiting the use of narcotic medications. the effective employment of non-opioid analgesics has been shown to reduce narcotic use (5). ibuprofen and other nsaids are the most effective and most commonly prescribed analgesics for postpartum pain, but clinicians now find themselves stuck between these recommendations and their efforts to limit unnecessary opioid prescriptions. the investigators propose a randomized controlled non-inferiority trial of women with preeclampsia comparing a postpartum analgesic protocol that includes nsaids, to one that excludes them. the central hypothesis is that nsaid use does not worsen hypertensive diseases of pregnancy.

Eligibility criteria:
inclusion criteria: * women at \> 23 weeks gestational age undergoing vaginal or cesarean delivery at barnes-jewish hospital with: * an antepartum diagnosis of preeclampsia with severe features * pre-eclampsia with severe features will be defined as: * elevated blood pressure ≥ 160/110, or * pre-eclampsia in the setting of thrombocytopenia (platelet count \< 100,000), or * impaired liver function (ast elevated to twice upper limit of normal), or * persistent epigastric pain, or * renal insufficiency (serum creatinine of 1.1 mg/dl or doubling of prior value), or * pulmonary edema, or * new onset visual disturbance or headache unresponsive to therapy. exclusion criteria: * nsaid allergy * allergy to acetaminophen * antihypertensive use in this pregnancy prior to 20 weeks gestation * chronic kidney disease or acute kidney injury with creatine clearance less than 60 ml/min * inability to obtain consent * opioid abuse disorder * peptic ulcer disease.

Keywords: nsaids ibuprofen
caregiver-guided pain management training in palliative care

Conditions: Advanced Cancer

Summary: the purpose of this study is to develop more effective ways to help patients and their caregivers cope with cancer pain. the investigators are looking at the usefulness of a caregiver-guided pain management training intervention versus pain education.

the primary aim of this study is to test the efficacy for the caregiver-guided pain management training intervention to improve the caregiver's self-efficacy for helping the patient manage pain. secondary aims include testing the effectiveness of the cg-pmt intervention to improve patient pain severity, patient self-efficacy for pain management and patient psychological distress, as well as short-term caregiver adjustment and caregiver adjustment following the patient's death. in this multi-site study, 236 dyads (patients with cancer pain and their family caregivers) will be randomized to either a caregiver-guided pain management training protocol or to an enhanced treatment-as-usual control condition. dyads in the caregiver-guided pain management condition will receive three one-hour sessions conducted via videoconference. dyads in the enhanced treatment-as-usual condition will receive educational material about cancer pain and its management but will not receive any study-related treatment sessions. assessments will be conducted with patients and caregivers before and after treatment, and with caregivers 3 months and 6 months following the patient's death. the primary hypothesis to be tested is that caregivers who receive the intervention will report significantly higher levels of self-efficacy for helping the patient manage pain than caregivers in the control condition. secondary aims will focus on (a) improvements in short-term caregiver adjustment as well as caregiver adjustment following the patient's death, and (b) patient pain severity, self-efficacy for pain management, and psychological distress.

Eligibility criteria:
patient inclusion criteria: 1. clinical diagnosis stage 4 solid or hematologic malignancy and nonresectable stage 3 gastrointestinal (gi) cancer 2. life expectancy of \< 1 month 3. worst pain in the past 2 weeks greater than or equal to 4 on the 0-10 pain scale, 4. have an identified caregiver who is also willing to participate, 5. at least 18 years old, 6) fluent in english. caregiver inclusion criteria: 1. at least 18 years old 2. fluent in english patient exclusion criteria: 1. palliative performance scale rating \<40, 2. current external radiation therapy for reduction of pain 3. unable to provide informed consent or complete study procedures as determined by clinical or study staff. caregiver exclusion criteria: 1) unable to provide informed consent or complete study procedures as determined by clinical or study staff.
safety and pharmacokinetics study of multiple ascending doses of bta-c585 in healthy volunteers

Conditions: Pharmacokinetics; Healthy Volunteers

Summary: this is a single center, sequential-cohort, double-blind, placebo-controlled, multiple ascending dose (mad), 7-day treatment period study in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. healthy men and women; 2. age 18 to 60 years, inclusive; 3. weight ≥ 50 kg and body mass index (bmi) of 19 to 32, inclusive; 4. female subjects must be of non-childbearing potential; 5. male subjects must agree to use a double barrier method of birth control; 6. signed informed consent form (icf) prior to study procedures. exclusion criteria: 1. current or recent (within 14 days of day 0) bacterial or viral infection; 2. positive results at screening for hepatitis b surface antigen, hepatitis c antibody, or hiv antibody; 3. clinically significant abnormalities noted on ecg; 4. safety laboratory abnormalities; 5. regular use of medications, prescription or non-prescription; 6. poor vein access or fear of venipuncture or sight of blood; 7. major surgery, significant recent injury or trauma within 30 days; 8. received an investigational drug or vaccine within 30 days.

Keywords: viral diseases antiviral paramyxoviridae infections rsv respiratory syncytial virus aviragen therapeutics, inc. aviragen therapeutics aviragen
arimidex/tamoxifen neo adjuvant study in premenopausal patients with breast cancer under anti hormonal treatment

Conditions: Breast Cancer

Summary: the purpose of this multi-centre, randomised, double-blind, parallel-group study is to compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative administration under goserelin acetate treatment for premenopausal breast cancer patients


Eligibility criteria:
inclusion criteria: * premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided written informed consent exclusion criteria: * medical history of chemotherapy or endocrine therapy for breast cancer, or with treatment history of radiotherapy. unwillingness to stop taking any drug known to affect sex hormone status (including hormone replacement therapy (hrt).

Keywords: breast cancer breast neoplasms tumors or cancer of the human breast tumor or cancer of the human mammary gland
to evaluate the optimum dose of platelet rich plasma in knee osteoarthritis and compare efficacy with hyaluronic acid

Conditions: Knee Osteoarthritis

Summary: randomized, double-blind, 12-month, placebo-controlled study was conducted on 100 outpatients . intervention platelet rich plasma( prp) prepared from 60 ml of blood by adding novel step of filtration to manual centrifuge step to achieve 7 times concentration. the efficacy was compared with administration of hyaluronic acid. subjective womac scores ,6 min pain free walking distance as well objective assessments mri ,synovial fluid assessments were made out .absolute counts of platelets as dose was evaluated to be effective in alleviating symptoms in early knee oa.

osteoarthritis (oa) causes substantial physical disability that limits a person ability to indulge in daily activities. oa related disability has been affecting millions of older adults throughout the world, and the number has almost doubled in 2019. though the process of oa could not be reversed, efficient management strategies could help in minimizing primary pain with physical exercises, surgical procedures, and medications. prolonged use of nonsteroidal anti-inflammatory drugs (nsaids) has been dramatically associated with mild to severe side effects, limiting its continuous use. chondro-protective agents (cpas) have been proven to provide only minimal symptomatic benefit. platelet-rich plasma (prp) has emerged as a supreme therapy in oa knee however exact dose ,preparation and duration of benefit still remains unclear. study was undertaken to demonstrate the potential of leukocyte depleted prp in cartilage repair of knee oa using womac scores as subjective assessment tool. our research also evaluated objective criteria ing joint space width (jsw),cartilage thickness on mri, ultrasound that would improve knee joint function in patients with knee oa.

Eligibility criteria:
inclusion criteria: * outpatients who fulfilled the clinical and radiological criteria set by the american college of rheumatology for the diagnosis of symptomatic primary knee oa, with pain visual analogue scale (vas) score of \>3 in the previous month. in cases where both the knees were symptomatic, the knee which was comparatively more painful was considered. exclusion criteria: 1. evidence of secondary knee oa because of injury, inflammatory or metabolic rheumatic disease, or osteonecrosis; 2. prior intra-articular injection of hyaluronic acid (ha), including lavage and corticosteroids within the previous three months; 3. severe knee oa, with jsw \<1 mm, or surgery required on the evaluated knee in the year 4. patients with clinically significant systemic disease.

Keywords: platelet rich plasma
atp expression in lymphocytes of ms patients by means of "immuknow®" assay.

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to see if we can find a new way to test how certain multiple sclerosis (ms) medications work in the body and to better understand how the medicines change certain substances (cells) found in the immune (protective) system. blood test will be drawn by doing the following: * use a new method called the "immuknow®" test to see if this method will help to better understand how ms medicines work. * measure certain levels of immune cells in a new way, to see if it this will help to understand the body's response to ms medicines. these methods will test those with ms who are not taking any ms medications, to help us compare the results. about 100 subjects will be enrolled in this study at the partners multiple sclerosis center at brigham and women's hospital. biogen idec, inc. of cambridge, ma, is paying for this study to be done.

the primary objective of this study is to determine the effects of various therapies (immunomodulatory as well as immunosuppressive) on atp levels in cd4+ cells and to determine whether the "immuknow®" assay is an appropriate screening tool to assess the immunocompetence of potential tysabri patients. secondary objective is to correlate the expression of atp in cd4+ cells with cd4+ cell count. tertiary objective is to examine the level of regulatory t-cells (cd4+ and cd25+) in ms patients and its possible correlation to the therapy used, and how well a recently proposed marker of regulatory t-cells, lap, correlates with cd25 marker.

Eligibility criteria:
inclusion criteria: 1. patients must be taking 1 of the following medications for 3 months or more: cytoxan, cellcept, novantrone betaseron, rebif, avonex or copaxone. 2. patients must be able to provide written informed consent. exclusion criteria: 1. patients on combination of multiple medications. 2. restricted treatment whereby no use in 50 days prior to enrollment visit is permitted: systemic steroids. 3. with educational completion below 8th grade school equivalent or non-fluent in english. 4. any other reason, in the opinion of both the investigator and/or sponsor, the patient is determined not suitable for study participation.