Kornimate/medical-research-clean huggingface dataset:
cannabidiol for the treatment of pelvic pain in endometriosis (dreamland)

Conditions: Endometriosis; Pelvic Pain

Summary: the objective of this work is to conduct a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of cannabis extract in women with endometriosis who have already undergone hormonal contraceptive treatment and surgery without satisfactory response.

the dreamland study is a two-arm, parallel-group, individually randomized (1:1 allocation ratio), controlled by disease stage, participant and investigator blinded, single-site superiority trial of oral cannabis extract (cbd). cbd will be given orally starting at 10 mg daily and up-titrated to a maximum dose of 150 mg daily. dose up-titration will be based on clinical response or side effects, whichever comes first. after 63 days of treatment, gradual withdrawal will be performed during one week. then, at 70 days, there will be an open-label extension wherein all participants from control group will be offered a course of cbd according to the same previous protocol. this research intends to : 1. assess whether the daily use of cbd, for nine weeks, will reduce the pain level of these women. 2. assess whether the daily use of cbd, for nine weeks, will modify pain threshold. 3. assess whether the daily use of cbd, for nine weeks, will interfere in psychological symptoms. 4. assess the possible adverse effects of using cbd

Eligibility criteria:
inclusion criteria: * women with chronic pelvic pain secondary to endometriosis surgically treated, with refractory symptoms, and who are taking complementary hormone therapy; * women over 18 years of age who wish to participate in the clinical trial; * willingness to voluntarily participate in the study to accept randomization to either of the two treatment arms; * participating exclusively in this clinical trial during the study period; * possess a telephone (cell or landline) that may be available to receive daily calls throughout the study period; * signature of the free and informed consent term (tcle) approved by the local research ethics committee. exclusion criteria: * chronic, severe or uncompensated medical conditions, such as: insulin-dependent diabetes (types 1 or 2); uncontrolled high blood pressure, lung disease such as asthma or other chronic obstructive pulmonary disease; hematological diseases, liver diseases, chronic kidney disease in advanced stage (grade 3, 4 and 5), metabolic disturbances and immunosuppression; * use of any medication with potential interaction with cbd/thc (such as chloroquine, clobazan, warfarin, or valproic acid) or history of undesirable reactions prior to the use of this medications; * inability to use oral medication; * pregnancy or lactation; * history of alcohol or drug addiction; * smoking in the last three years; * marijuana use in the past three months or a lifetime history of dependence; * inability to cooperate with investigators due to cognitive impairment or mental status.

Keywords: cannabis endometriosis pelvic pain
epidural stimulation after neurologic damage: long-term outcomes

Conditions: SCI - Spinal Cord Injury

Summary: this study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.

participants will be enrolled in this study for the duration of 10 years. they will need to come to minneapolis twice a year for the brain motor control assessment and will be given different settings within their spinal cord stimulator (scs) programing.

Eligibility criteria:
inclusion criteria: * 22 years of age or older * able to undergo the informed consent process * stable spinal cord injury * international standards for neurological classification of spinal cord injury (isncsci) neurologic level of injury below c5 * no ventilator dependency within the last year * american spinal injury association (aisa) imparement scale"a" or "b" in the absence of spinal cord stimulation * medically stable in the judgment of the principal investigator * greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation and 2 months from spinal cord stimulator surgery * has an existing and functional implanted spinal cord stimulator system that is fda approved and can be corroborated by hospital documentation * spinal imaging of the stimulator system exclusion criteria: * current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator * use of botulinum toxin (botox) injections in the previous six months * clinically significant mental illness in the judgment of the principal investigator * other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator * nonfunctional spinal cord stimulator or near end-of-life, determined by the pi * current pregnancy * current pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.

Keywords: spinal cord stimulation epidural stimulation
pre-procedural information sheet reduces anxiety of patients before urodynamic studies

Conditions: Anxiety

Summary: urodynamic study may lead to significant anxiety. our hypothesis is that urodynamic study is that pre-procedural explanation note about the test may reduce the anxiety level of the patients.

urodynamic study is one of the most common procedures in urological outpatient practice. patients who wait for the tests may experience significant anxiety. in this study, patients who are designated to have multichannel urodynamic study will be randomized to two groups: group 1 - patients who received an explanation note about the test; group 2 - patients who did not receive the note. the explanation notes will be sent to the patients in group 1 by mail one month before the test. investigators will use the state anxiety inventory (sai) in order to assess emotional distress immediately before the test. comparison opf the anxiety level between the two groups will be performed.

Eligibility criteria:
inclusion criteria: all patients who will be referred for urodynamic studies in order to evaluate lower urinary tract symptoms. exclusion criteria: 1. inability to complete the questionnaire due to mental disorders 2. patients who had undergone urodynamic study previously

Keywords: anxiety urodynamics
brain-gut yoga for functional dyspepsia and gastroparesis (fd-gp)

Conditions: Functional Dyspepsia; Gastroparesis

Summary: the purpose of this research study is to assess whether using a yoga-based intervention in practice is feasible (possible) and acceptable to patients with functional dyspepsia and/or gastroparesis (fd-gp).

this research looks to adapt an existing seated yoga intervention, designed for patients with gi cancer, for testing in patients with disorders of the upper gi tract by conducting a field test with fd-gp patients to assess feasibility and acceptability and refine the adapted intervention.

Eligibility criteria:
inclusion criteria: * 18 years and older * functional dyspepsia or gastroparesis (fp or gp) diagnosed by a physician using standard criteria * signed, written consent exclusion criteria: * co-morbid gastrointestinal or related disorders documents in the medical record: celiac disease, inflammatory bowel disease(active), gastrointestinal obstruction (if current in the last 6 months), any gi surgery within the last 6 months), chronic pancreatitis or any pancreatic or biliary disease, cirrhosis or any chronic liver disease other than metabolic associated hepatic disease (mash), any malignancy (except skin cancer already resected and surgically in remission) * a positive screen for the following: current psychotic symptoms, elevated suicide risk, active eating disorder, cognitive impairment, current harmful alcohol or substance use * does not understand english * underwent a regular yoga or other mediative movement practice (tai chi or qi gong) in the past 6 month

Keywords: yoga disorders of the upper gastrointestinal (gi) tract brain-gut behavior
post marketing surveillance of diphtheria antitoxin (dat)

Conditions: Safety Issues

Summary: the aim of this study is to evaluate the safety profile of diphtheria antitoxin

to assess the occurrence of serum sickness after diphtheria antitoxin administration. to assess local and systemic reactions within 24 hours to 10 days. to assess the occurrence of positive reactions after the sensitivity test (skin test). to assess the presence of sae after diphtheria antitoxin administration.

Eligibility criteria:
inclusion criteria: * subjects with a probable diagnosis or laboratory confirmation of diphtheria. * subjects who received therapy with the intended dat exclusion criteria: * receiving a different brand of diphtheria antitoxin (dat)
thrombocytopenia drug immune validation of new biological test diagnostic

Conditions: Thrombocytopenia

Summary: the drug immune thrombocytopenia (tim) are the most common drug cytopenias. they result from a peripheral destruction of platelets in the presence of the drug only. they usually involve immunoglobulin g (igg) directed against either the drug molecule bound to a carrier protein or, by autoimmunity, against a hidden epitope newly exposed as a result of treatment. the most common drugs involved are quinine, some antibiotics, nonsteroidal anti-inflammatory drugs or anticonvulsants but the list is not exhaustive. in the case of new-onset thrombocytopenia and after eliminating other possible causes, a tim is suspected but the offending drug is difficult to identify in generally poly-medicated patients. several drugs may be suspected and the clinician uses biology for rapid assistance to the "de-prescription" and reduces unnecessary therapeutic substitutions in an always difficult clinical situation. the immunology laboratory of the university hospital of saint-etienne has developed a biological test of thrombocytopenia induction in the presence of the drug and the patient's serum that is to say its antibodies and complement fractions with cytometry reading flow. this induction test in vitro tim (titim) is simple, fast, inexpensive, easy to transfer in hospital laboratories. but this test must be validated on well-documented clinical cases. the purpose of this pilot project is to validate the technical and assess the clinical specificity of the test titim for hard imputability drugs validated by a committee of experts combining a posteriori of clinical and biological criteria of routine.


Eligibility criteria:
inclusion criteria: * hospitalized patients with suspicion of thrombocytopenia drug * consent signed exclusion criteria: * thrombocytopenia plants such as secondary to the following molecules: antineoplastic (except oxaliplatin which gives tim), immunosuppressants. * induced thrombocytopenia heparin and iib / iiia glycoproteins (abciximab, tirofiban, epifibatide). * presence of anti platelet antibodies allogeneic or autoimmune which are part of the maipa test. * patient exposed to at least one suspect molecule does not exist in water-soluble form or drug to which the metabolite is suspected * patients transfused (plasma, platelets) for less than a month * patients with an other bloodline

Keywords: validation new test
a 12 week, phase ii trial to evaluate the efficacy and safety of win-34b in patients with osteoarthritis of the knee

Conditions: Osteoarthritis, Knee

Summary: this trial is a multi-center, randomized, double-blind, placebo-controlled, parallel, phase ii clinical trial and aimed at osteoarthritis of the knee. patients who signed informed consent voluntarily and eligible for this study are assigned randomly to one of 3 groups after 2 week-washout period. 1. st group (experimental) : win-34b 450mg bid 2. nd group (experimental) : win-34b 900mg bid 3. rd group (comparator) : placebo bid patients will take win-34b or placebo bid for 12 weeks. based on baseline, after 4 weeks(visit 3) and 12 weeks(visit 5), researchers check patients' physical examination, questionnaire, laboratory experiment. after 8 weeks(visit 4), researchers check adverse effects and current medication status via telephone interview. after 12 weeks(visit 5) patients stop taking drugs and after 16 weeks(visit 6) researchers check patients' physical examination, questionnaire, adverse effects and current medication status.


Eligibility criteria:
inclusion criteria: 1. being between 35 and 80 years of age 2. diagnosed with osteoarthritis of the knee at least 3 months 3. diagnosed with osteoarthritis of the knee, based on acr criteria 4. able to communicate with researchers and write questionnaires 5. at the screening visit, checking 100mm pain vas at least 80mm 6. at randomization(visit 2), checking 100mm pain vas over 50mm 7. agreeing to participate and signing informed consent voluntarily exclusion criteria: 1. previous intra-articular injection on knee within 3 months 2. previous knee surgery within 6 months or scheduled procedures 3. other diseases that could affect or interfere with the therapeutic outcomes 4. experiencing habitual use of psychotropic, narcotic analgesic drugs over 1 week 5. diagnosed with gastrointestinal diseases, unable to stop medicines during the study 6. at the screening visit, identified liver dysfunction 7. at the screening visit, identified renal dysfunction 8. patients who cannot take nsaids 9. pregnancy and breast-feeding (women of childbearing age need pregnancy test) 10. physicological or mental disorders, including drug-takers 11. orthopedic diseases that could affect or interfere with the therapeutic outcomes 12. inappropriate for the study

Keywords: osteoarthritis, knee win-34b
occlusion balloon vs. 5fr ureteral catheter

Conditions: Kidney Stones

Summary: occlusion balloon catheter provides the ability to occlude the exit of the kidney pelvis during percutaneous nephrolithotomy (pcnl) and potentially prevents the migration of stone fragments into the ureter. the necessity for it might be questioned during supine pcnl due to the upward oblique position of the kidney. the objective of the study is to compare the presence of ureteral stone fragments upon completion of supine pcnl with and without using an occlusion balloon catheter (obc).


Eligibility criteria:
inclusion criteria: * adults aged 18 years and older. * diagnosed with kidney stones and scheduled for pcnl. * able and willing to provide informed consent. exclusion criteria: * pregnant women * urinary tract anomalies such as urinary diversion, previous ureteral reconstruction surgeries, horseshoe kidney, solitary kidney, duplicated system, urinary stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum. * prone procedure

Keywords: percutaneous nephrolithotomy pcnl occlusion balloon catheter kidney stone
adherence intervention in patients with metastatic breast cancer

Conditions: Breast Cancer

Summary: to evaluate the preliminary efficacy of a multicomponent adherence intervention focused on enhancing digital equity and pharmaco-equity among nonadherent patients with metastatic breast cancer (mbc) and cardiovascular disease (cvd) risk factors on endocrine therapy (et), cdk4/6 inhibitor (cdk 4/6i), and cvd medications. to assess the acceptability and appropriateness of this intervention in patients with mbc and cvd risk factors through validated measures of implementation outcomes. to gain a deeper understanding of the impact of social determinants of health (sdoh) on medication nonadherence through semi-structured interviews with a subset of study participants.


Eligibility criteria:
inclusion criteria: * women or men age \>18 years * diagnosed with stage iv/metastatic breast cancer prescribed endocrine therapy and a cdk4/6i * prescribed at least 1 antihypertensive or statin medication for cvd prevention or treatment * self-report of at least some nonadherence et/cdk4/6i or cvd medication on nonadherence screener or verbally to a treating clinician, or nonadherent to et, cdk4/6i, and/or cvd medication on pharmacy fill data in the ehr (proportion of days covered over prior 180 days \<80%). exclusion criteria: * non-english or non-spanish speaking * not cognitively able to complete study requirements * inability to provide informed consent for any other reason (e.g, severe psychiatric illness, active substance use) * unavailable for 28 weeks of follow-up
the effect of aerobic exercise on neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and lymphocyte-monocyte ratio in burn patients: a randomized controlled study

Conditions: Burns; Physiotherapy; Aerobic Exercises

Summary: in the study, it was planned to investigate the effect on neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and lymphocyte-monocyte ratio in burn patients by creating 2 different exercise groups. the aim of this study is to investigate the effect of aerobic exercise on neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and lymphocyte-monocyte ratios in burn patients.

burn injuries are a trauma that is seen due to causes such as flame, hot liquid, radiation, chemical, cold or electricity and causes destruction in the skin and/or organic tissues due to energy transfer. burn injuries cause profound hypermetabolic and catabolic responses that can last for months or even years. especially in burn patients with involvement of more than 20% of the total body surface area (tvsa), lipolysis, proteolysis, glycolysis, and hyperdynamic and high fever, many severe hypermetabolic responses are seen. these hypermetabolic responses seen in patients lead to decrease in lean muscle mass, inflammation, deterioration of cardiovascular, endocrine and glucose systems, coagulopathy, deterioration of fibrinolytic activity, decrease in functional capacity, delay in wound healing, weakening of the immune system and serious mortality. in severely burned patients, the resting metabolic rate may exceed 140% of normal. various parameters are used to monitor all these systemic responses of the burn. various scores have been developed in the clinic, especially using inflammatory cells such as neutrophils, monocytes, lymphocytes and platelets. in the literature, major diseases such as cancer, heart diseases and burns it has been stated that a systemic inflammation occurs due to trauma and calculations of neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and lymphocyte-monocyte ratios are prognostic indicators. exercise in burn patients; it is a highly effective method with high evidence value in minimizing the effects of the hypermetabolic response caused by the burn, preventing muscle atrophy, increasing the pulmonary function and functional capacity, reducing the inflammatory response and healing the burn.

Eligibility criteria:
inclusion criteria: inclusion criteria: conscious patients enterally fed \>18 years old exclusion criteria: with inhalation burn in addition to existing burn trauma, those with other trauma (fracture, loss of limb, etc.) organ dysfunctions or multiple organ failure history of chronic diseases such as diabetes, cholesterol and blood pressure -

Keywords: burns, neutrophil lymphocyte ratio platelet-lymphocyte ratio lymphocyte monocyte ratio
a clinical study to evaluate car-t cell-based medicinal product in the treatment of advanced solid tumors

Conditions: Solid Tumors, Adult

Summary: this is a prospective, single-arm, open-label phase 1 dose-finding and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based lcar-c18s (hereinafter "lcar-c18s") in subjects with claudin18.2-positive advanced solid tumors.

this is a prospective, single-arm, open-label phase 1 dose-finding and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based lcar-c18s (hereinafter "lcar-c18s") in subjects with claudin18.2-positive advanced solid tumors. patients who meet the eligibility criteria will receive lcar-c18s infusion. the study will include the following sequential phases: screening, pre-treatment , treatment and follow up

Eligibility criteria:
inclusion criteria: 1. the subjects have been fully informed of the possible risks and benefits of participating in the study and have signed the informed consent form; 2. age 18-70 years; 3. immunohistochemistry of tumor tissue samples indicates claudin18.2 positive ; 4. recurrent or metastatic advanced solid tumors (including advanced gastric cancers and non-gastric cancers) and have been failed to prior lines of systemic treatment 5. according to the recist v1.1, at least one measuable tumor lesion; 6. ecog performance status score of 0-1; 7. expected survival ≥ 3 months; 8. subjects should have adequate organ functions before screening and treatment. 9. women of childbearing age must have a negative blood pregnancy test; subjects of childbearing potential must use effective contraception for ≥ 1 year after the final study treatment. exclusion criteria: 1. previous car-t cell therapy or other cell therapies or therapeutic tumor vaccination against any target; 2. any previous therapy targeting claudin18.2; 3. prior antitumor therapy with insufficient washout period; 4. pregnant or lactating women; 5. brain metastases with central nervous system symptoms; 6. uncontrolled diabetes; 7. oxygen is required to maintain adequate blood oxygen saturation; 8. gastric perforation, pyloric obstruction, complete biliary obstruction, complete or incomplete intestinal obstruction requiring clinical intervention, or pleural effusion or peritoneal effusion requiring clinical intervention; 9. clinically significant liver disorders (including liver cirrhosis, active viral hepatitis or other hepatitis); 10. hiv, treponema pallidum or hcv serologically positive; 11. severe underlying disease 12. new york heart association (nyha) class iii or iv congestive heart failure or left ventricular ejection fraction (lvef) \< 50%; unstable angina, myocardial infarction or coronary artery bypass grafting (cabg) in the past 6 months; history of severe non-ischemic cardiomyopathy; or severe uncontrolled arrhythmia; 13. any condition that, in the opinion of the investigator, will make the subject unsuitable for participation in this study.
heat wrap device safety with age and body fat

Conditions: Back Pain

Summary: this study is designed to compare the safety, as measured by skin findings and adverse events, of two different heat devices in elderly, overweight, and elderly and overweight subjects.

safety measurements

Eligibility criteria:
inclusion criteria: * males or females in generally good health, and who are either 18-54 years of age with a body mass index of ≥ 30 kg/m2 * or 55-84 years of age and with a body mass index ≥ 30 kg/m2 or \< 30 kg/m2 * females who are not pregnant or breastfeeding * subject is medically cleared for study participation exclusion criteria: * no sensitivity or allergy to device components in contact with skin * diabetes * any active skin disease or tattoos at the test site that would affect participation

Keywords: heat device safety performance heatwrap elderly overweight