Kornimate/medical-research-clean huggingface dataset:
the effect of hydrogen-rich water on premenstrual symptoms and quality of life

Conditions: Premenstrual Syndrome

Summary: the aim of this study is to determine the effect of hydrogenated water on premenstrual symptoms and quality of life in students with premenstrual syndrome. research hypotheses h1 1 hydrogenated water consumption reduces premenstrual symptoms in students with premenstrual syndrome. h1 2 hydrogenated water consumption increases the quality of life in students with premenstrual syndrome. the research will consist of intervention and control groups. individuals consuming hydrogen-rich water will be included in the intervention group, whereas individuals consuming normal water will be in the control group. the block randomization method will be used to randomly assign participants who meet the research criteria to the groups. participants will be provided with hydrogenated water for three cycles.


Eligibility criteria:
inclusion criteria: * the length of the menstrual cycle is within normal limits (21-35), * getting a score of 132 or more from the premenstrual syndrome scale, * not receiving medical treatment for pms, * not having any psychiatric diagnosis. exclusion criteria: * • irregular menstruation in the last three cycles * having received a psychiatric diagnosis, * having any gynecological disease (abnormal uterine bleeding, myoma, ovarian cyst, etc.) * using contraceptive medication. * individuals' refusal to participate in the study, * participants' non-compliance with the research plan, * participants start receiving pms treatment during the study period.
changes of inflammatory cytokines in the tears of moderate and severe mgd treated with topical loteprednol etabonate

Conditions: Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)

Summary: meibum lipids are modified in patients with mgd, resulting in tear instability, evaporative dry eye, and eyelid inflammation. these changes add to corneal damages and exacerbate ocular symptoms, which are all associated with the constant release of inflammatory mediators. to our knowledge, there has been no study on tear cytokine levels in mgd patients treated with topical loteprednol etabonate. the investigators, thus, evaluated both inflammatory tear cytokine levels and corresponding clinical outcomes for analyzing the efficacy of topical loteprednol etabonate in moderate and severe mgd. the aim of this research was to determine the concentration of inflammatory tear cytokines in patients with mgd and to compare the changes in tear cytokine levels between topical loteprednol etabonate and warm compress treatment group and warm compress only treatment group.


Eligibility criteria:
inclusion criteria: (1) stage 3 or 4 meibomian gland dysfunction exclusion criteria: 1. history of previous ocular or intraocular surgery 2. ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease, 3. history of intolerance or hypersensitivity to any component of the study medications, 4. wearing contact lenses during the study period, presence of current punctal occlusion, 5. pregnancy, lactating women, and children. 6. additionally, patients were excluded if they were using any topical ocular or systemic medication that could be used for the treatment mgd or dry eye, including topical or oral antibiotics, topical cyclosporine a, topical or oral steroids, topical non-steroidal anti-inflammatory drugs, topical ocular allergy medications or artificial tears
reveal: reduction of infarct expansion and ventricular remodeling with erythropoietin after large myocardial infarction

Conditions: Acute ST Elevation Myocardial Infarction

Summary: the purpose of this study is to evaluate whether erythropoietin can help limit the damage to the heart in patients with acute heart attacks.

reveal is a randomized, double-blinded, placebo-controlled, parallel phase ii clinical study that will evaluate the effects of erythropoietin administration on infarct size, left ventricular remodeling and circulating endothelial progenitor cells in patients with large myocardial infarctions (mi). the study will be conducted in two phases: a dose-escalation safety phase and a single dose efficacy phase. eligible patients who present to the hospital with an acute st-elevation mi and who agree to participate in this study will be randomly assigned to receive a single infusion of study medication consisting either of erythropoietin or placebo. the size of the infarction and the dimensions of the heart will be assessed by cardiac magnetic resonance imaging (mri) within 2-6 days of the infusion of the study medication, and again approximately 3 months later.

Eligibility criteria:
* inclusion criteria: age greater than 21 years acute st-elevation myocardial infarction referral for primary or rescue angioplasty revascularization procedure within 8 hours from the onset of ischemic symptoms timi (thrombolysis in myocardial infarction) flow grade 0 or 1 in the culprit coronary artery at the beginning of coronary angiography successful revascularization of infarct-related artery exclusion criteria: clinical indication for erythropoietin stemi (st-elevation myocardial infarction) due to occlusion of a branch vessel any history of prior mi, pci (percutaneous coronary intervention), cabg (coronary artery bypass graft), cardiomyopathy, myocarditis, or chf (congestive heart failure) hypersensitivity to human albumin, mammalian cell-derived products, or erythropoietin hematocrit greater than 42% in men or greater than 40% in women at the time of study drug administration uncontrolled hypertension at the time of study drug administration cardiogenic shock need for coronary surgical revascularization as determined at the time of the index coronary catheterization history of hypercoagulable disorder, thromboembolic event, or venous thrombosis history of stroke or tia (transient ischemic attack) history of seizures contraindication to mri pregnancy or nursing mother

Keywords: acute myocardial infarction left ventricular remodeling cardiac magnetic resonance imaging endothelial progenitor cells infarct size
evaluation of the beneficial effects of a probiotic product in healthy adult subjects.

Conditions: Disbiosis; Abdominal Pain; Constipation; Diarrhea; Stress

Summary: a randomized, double-blind, placebo-controlled, cross-over trial performed at one centre in italy to explore the ability of a multistrain probiotic mixture, to modulate markers of inflammation and intestinal barrier function and gastrointestinal symptoms in healthy volunteers with self-reported anxiety.


Eligibility criteria:
inclusion criteria: eligible subjects were healthy men and women, 20-35 years old, with a stai scale, form y, module 1 (state anxiety) score of ≥ 35 and ≥40, for men and women, respectively. exclusion criteria: most important exclusion criteria were history or diagnosis of gi disease, oral antibiotics within 30 days prior to the screening visit, and use of drugs, food or herbal supplements for digestive symptoms.

Keywords: lactoflorene plus bifidobacterium animalis subsp. lactis, bb-12® lactobacillus acidophilus, la-5® lactobacillus paracasei subsp. paracasei, l. casei 431® inflammation gut permeability disbiosis probiotic iga il10
comparison of intrathecal dexmedetomidine versus fentanyl as adjuvants to bupivacaine on post-operative urinary retention in knee joint arthroscopic surgeries

Conditions: Post-Op Complication

Summary: the aim of this study was to assess the effect of intrathecally injected 5 µg dexmedetomidine or 25 µg fentanyl as adjuvants to bupivacaine in low dose spinal anesthesia for unilateral arthroscopic knee surgeries, on post-operative urinary retention (pour), time needed to reach sensory block at the tenth thoracic dermatome (t10), the maximum sensory level achieved, the onset of motor block, the intra-operative fluids given, the duration of sensory and motor blocks, time to micturition or insertion of an intermittent urinary catheter and the number of patients who needed an indwelling (foley's) catheter. seventy patients, asa physical status i or ii, from 21 to 50 years old, scheduled to undergo unilateral arthroscopic knee surgeries under spinal anesthesia, were randomly divided into two equal groups; the bupivacaine- dexmedetomidine group (bd) patients and the bupivacaine-fentanyl group (bf) patients.


Eligibility criteria:
inclusion criteria: * asa physical status i and ii * aged 21-50 years * scheduled to undergo unilateral arthroscopic knee surgeries under spinal anesthesia exclusion criteria: * patients' refusal * contraindications to spinal anesthesia * patients with coagulopathy * infection at the lumbar region * pre-existing neurological deficits in the lower limbs * known allergy to any of the study drugs * urinary incontinence * cysto-ureteric reflux * patients with congestive heart failure * patients with dysrhythmia * patients with heart block * diabetic patients * patients on α2-adrenergic receptors antagonists * calcium channel blockers
tailored antiplatelet therapy during percutaneous coronary intervention in patients with diabetes mellitus

Conditions: Diabetes Mellitus

Summary: the researchers aimed to investigate the effect of point-of-care platelet function assay on the periprocedural cardiac enzyme elevation in patients with diabetes mellitus. all patients who are supposed to undergo coronary angiography were loaded with clopidogrel (300mg) and aspirin (300mg) at d-1. if patients were determined to implant coronary stent after diagnostic coronary angiography, their platelet function is assayed with verifynow-adp (accumetrics). if patients have \>270 unit in the assay, they are randomized to abciximab or control group. after successful stent implantation, cardiac enzymes (ck-mb, troponin-i) are followed at 8hr, 16hr and 24hr. clinical outcomes including bleeding complications are assessed at 1 month.


Eligibility criteria:
inclusion criteria: * patients who were determined to implant drug-eluting coronary stent * diabetes mellitus (type 1 or 2) exclusion criteria: * age \ 80years * patients with acute myocardial infarction * patients with history of cerebral hemorrhage ever or ischemic infarction within 2 years * patients with history of major surgery (abdominal, thoracic, intraocular) within 6 months * patients who have have allergy to antiplatelet medications (aspirin, clopidogrel, abciximab) * patients who are on anticoagulation therapy * serum creatinine \>2.0mg/dl or alt/ast \> 3 times of upper normal limit (120 u/l)

Keywords: platelet reactivity platelet function assay abciximab tailored therapy
t-genvih-003 ltfu (long term follow up) study

Conditions: Hernia; Hernia, Ventral; Pathological Conditions, Anatomical; Hernia, Abdominal

Summary: the t-genvih-003 study will collect additional, longer term performance data of gentrix® surgical matrix used for reinforcement of ventral hernia repairs from a subset population (i.e., the twenty-one minimally invasive surgical approach cases) from the prior t-genvih-002 study.

the purpose of this study is to collect additional safety data and demonstrate the performance of integra gentrix® surgical matrix for reinforcement of ventral hernia repairs from a sub-population of twenty-one participants from the previous t-genvih-002 study, specifically those with laparoscopic or robotic repair. prospective data will be collected via a one-off study follow-up visit and assessed for later post-operative surgical site events and complications in the post-operative period from the last timepoint of data collection in t-genvih-002 to present.

Eligibility criteria:
inclusion criteria: * patient was a subject in the t-genvih-002 study and underwent minimally invasive (i.e., laparoscopic or robotic) abdominal wall reconstruction for a primary hernia using integra® gentrix® surgical matrix. * subject has participated in the informed consent process and signed a study-specific informed consent document. * subject is fluent in us english or us spanish language. * subject is willing to complete an e-consent and phone or in-office visit. exclusion criteria: * not applicable.
evolution of the therapeutic care in lung cancer in france since 2015 (esme lc)

Conditions: Lung Cancer

Summary: this database compiles data from existing data available from patient's electronic medical records (emr) at the 38 participating hospitals (20 french comprehensive cancer centers and 18 public hospitals).

the database includes data related to patient demographics, tumor characteristics (diagnosis, histology, relapses, metastatic disease, etc.), treatments (dates, inn, route of administration, treatment protocols, reason for termination, etc.), and clinical events. data is collected at each participating site by technicians who are specifically trained for the project using an electronic data collection (edc) tool. data imported into the final database are controlled, recoded, and harmonized before import according to the data management plan. all coding procedures are predefined by the data manager. there is no transmission of individual data; all data are centralized within each center using a shared anonymous format. all data is exclusively obtained retrospectively; no attempts are made to recover non available data from the patient's medical record by contacting healthcare providers or patients. esme lc data platform aims to be a clinical and therapeutic database centralizing existing and available data from different sources used in the participating sites. data do not contain any personal data on patients. in compliance with the authorization delivered by the french data protection agency to unicancer, only aggregated statistical reports and publication are released.

Eligibility criteria:
inclusion criteria : * adult (over 18) * treated (with radiotherapy or systemic anti-cancer treatment) for a lung cancer or diagnosed with metastatic lung cancer over the selection period at one of the participating site exclusion criteria - none

Keywords: lung cancer observational study survival real world data real life setting
the effect of rigid taping in chronic stroke patients with knee hyperextension

Conditions: Chronic Stroke

Summary: in this study, it is aimed to examine the effect of rigid taping on hyperextension control in stroke patients with knee hyperextension in the stance phase of gait. hypothesis ho: rigid taping has no effect on the control of knee hyperextension in stroke patients. h1: rigid taping has an effect on the control of knee hyperextension in stroke patients.


Eligibility criteria:
inclusion criteria: * having had a stroke at least 6 months ago * ambulation with or without a walking aid (walker, cane or tripod) * to be between 0-3 points according to the modified rankin scoring * presence of spasticity in any of the lower extremity muscles with a value of at least 1 according to the modified ashworth scale * getting a score of 24 or higher on the mini mental test * presence of hyperextension in the stance phase of gait exclusion criteria: * having more than one stroke history * being diagnosed with dementia * having a previous diagnosis of orthopedic, psychiatric or other neurological disease * having a situation that prevents communication * history of surgery or joint contracture involving the lower extremities and gait

Keywords: gait analysis stroke knee hyperextension rigid taping
prospective, open-label study of seraph 100 in patients with prolonged covid (pc)

Conditions: Long COVID

Summary: this study will use a prospective, open, single-arm design, in which a group of 100 patients with a diagnosis of prolonged covid, previously selected according to inclusion and exclusion criteria, and who have undergone informed consent process and have signed the informed consent form, undergo two hemoperfusion procedures with the seraph 100 filter, on consecutive days. they are then evaluated at day 3 and 4 weeks, to complete the safety and effectiveness assessment.

this will be a prospective, open-label, single-arm, pilot study, in which a group of 100 pc patients will undergo two hemoperfusion procedures, to verify the safety and preliminary efficacy of the seraph 100 device. eligible patients will be invited to participate and once they sign the informed consent (ic) they will undergo two hemoperfusion procedures, on consecutive days, of -4 hours duration each time, using a multicomponent apheresis machine with the seraph 100 filter. patients will be followed for a total of 30 days, to monitor the presence of aes (safety) and possible changes in clinical outcomes (preliminary efficacy).

Eligibility criteria:
inclusion criteria: subjects will be considered eligible for participation in the study if they meet all the following inclusion criteria: 1. adult patients age of 18-85 (had 18th birthday but did not have 85th birthday). 2. history of covid 19 infection established by positive polymerase chain reaction (pcr) test or by compatible clinical testing (e.g. rapid antigen, serum testing, or other relevant clinical documentation). 3. persistent symptoms for 12 or more weeks after acute covid 19 infection including fatigue and one or more of the following: myalgia or generalized aches and pains; joint pain; dizziness or unsteadiness; cognitive dysfunction (mental fog). 4. patient (legally designated representative) has completed the informed consent process prior to enrollment into this study. 5. patient (legally designated representative) is willing to comply with the study protocol - exclusion criteria: subjects meeting any of the following criteria will not be recruited for the study: 1. history of heparin allergy. 2. history of heparin-induced thrombocytopenia. 3. pregnancy or breastfeeding. 4. life expectancy is less than 30 days. 5. the patient is currently enrolled in another drug or device trial. patients who cannot tolerate placement of double-lumen catheter. 6. unable to obtain informed consent from either patient or legally authorized representative (lar)any subject who, in the investigator's judgment, is considered unsuitable for participation in this trial. after verification of eligibility and signature of consent: 1. the patient must be able to perform a hemoperfusion procedure with an apheresis machine.
efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis(oa)

Conditions: Osteoarthritis

Summary: this 39-week, open label study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (oa) of the knee who participated in the 13-week core ccox189a2360 study.


Eligibility criteria:
inclusion criteria: * have completed the core ccox189a2360 study * males and females over the 18 years old exclusion criteria: * treatment in the extension study is not considered appropriate by the treating physician * non-compliance or major protocol violation of the core study other protocol-defined inclusion/exclusion criteria may apply

Keywords: osteoarthritis lumiracoxib celecoxib cox-2 knee
phase 2a study examining the safety and efficacy of bol-dp-o-04 for treating diabetic neuropathy

Conditions: Diabetic Neuropathy

Summary: this is a randomized, double-blind, placebo-controlled phase 2a study examining the safety and efficacy of bol-dp-o-04 for treating diabetic neuropathy

a phase 2a, two-center, randomized, double-blind, placebo-controlled study in which subjects will be randomized to receive either bol-dp-o-04 or placebo in addition to standart of care. the study evaluates the effect of bol-dp-o-04 for diabetic neuropathy. the study includes a screening period up to three weeks followed by a 12-week treatment period

Eligibility criteria:
inclusion criteria: 1. male or female subjects with type 1 or type 2 diabetes 2. diabetes duration of at least 1 year 3. hba1c 6%-12% 4. 18 years of age or older 5. diabetic neuropathy for at least 6 months 6. failed or uncontrolled treatment of diabetic neuropathy following treatment with at least two drugs from the following drug list (pregabalin / dulexatine/ amitriptyline / gabapentin /carbamazepine) for a duration of at least three months for each drug 7. score equal or above 50% in dn4 questionnaire exclusion criteria: 1. neuropathic pain other than diabetic 2. a score of less than 50% on dn4 questionnaire 3. history of substance abuse (alcohol / illegal drugs) 4. history of cannabis or cannabis product usage in the last three months 5. any decompensated chronic disease 6. pregnancy/lactation 7. participant in other clinical trial during the last 30 days 8. a current of history of cancer during the last year 9. any mental/psychiatric illness in first-degree relative in a young patient \<30 years old. 10. any food allergy 11. history of amputation 12. any disorder which in the investigator's opinion might jeopardize the subject's safety or compliance with the protocol 13. patients with known allergy to one or more of the study drug components. 14. patient with uncontrolled congestive heart failure 15. subjects who get the following medications: opiates, primidone, phenobarbitol, carbamazepine, rifampicin, rifabutin, troglitazone, and hypericum perforatum 16. patients with psychotic state in the past or anxiety disorder 17. subject with a history of addiction or drug abuse.
evaluating in vivo parp-1 expression with 18f-fluorthanatrace positron emission tomography (pet/ct) in prostate cancer

Conditions: Prostate Cancer

Summary: men with a history of prostate cancer may be in this study. subjects recommended for a prostatectomy or oligometastectomy will undergo pet/ct imaging using a novel radiotracer \[18f\]ftt to evaluate parp-1 activity in known or suspected sites of primary or metastatic disease. imaging will be compared with pathology results, including additional research assays when possible.


Eligibility criteria:
inclusion criteria: * participants will be ≥ 18 years of age * biopsy proven prostate cancer * must meet one of the following criteria: 1. at least two tissue cores containing at least 50% tumor (per pathology report) or 2. at least one lesion that is 1 cm or greater in size by standard imaging (e.g. ultrasound, mri, ct). only one type of imaging is required to show a lesion of 1 cm or greater in order for the patient to be eligible to participate in this study. * recommended for clinically indicated radical prostatectomy or oligometastectomy * willing to allow use or collection of pathology tissue for the purposes of research from either clinical biopsy or surgical procedure (if adequate tissue is available) * participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures. exclusion criteria: * inability to tolerate imaging procedures in the opinion of an investigator or treating physician * serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study. * only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study. individuals who are considered to be mentally disabled will not be recruited for this study. all subjects must understand and be able to give informed consent. we will not be using specific methods to assess decisional capacity. economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation. all individuals will be told that their choice regarding study participation will in no way change their access to clinical care. this should negate any undue influence or coercion. women, children, fetuses, neonates, or prisoners are not included in this research study.