Kornimate/medical-research-clean huggingface dataset:
gi complications in cancer immunotherapy patients

Conditions: Malignant Melanoma

Summary: the purpose of this study is to establish a prospective observational cohort of cancer immunotherapy patients with gi side effects in order to identify biomarkers that predict gi complications due to treatment.

primary objective * to create a data and bio-specimen repository to enhance both safety and efficacy of immunotherapy secondary objective * identify biomarkers that may predict gi toxicity in cancer patients undergoing immunotherapy * define the clinical course of intestinal inflammation and identify genetic factors of therapeutic response to gi medications * analyze genotype-phenotype correlations in gi side effects in patients undergoing cancer immunotherapy

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cancer * currently undergoing or have undergone immunotherapy exclusion criteria: * history of a total colectomy * history of inflammatory bowel disease (either ulcerative colitis or crohn's disease) * history of colitis on chemotherapy

Keywords: cancer immunotherapy ipilimumab
efficacy of paracervical block in laparoscopic myomectomy: a randomized controlled trial (palm)

Conditions: Uterine Fibroid

Summary: it remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in laparoscopic myomectomy (lm), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to lm for benign gynecologic conditions on postoperative pain relief.

however, no study investigating the efficacy of paracervical block in laparoscopic myomectomy on postoperative pain was conducted, to date. therefore, the goal of this study is to evaluate whether patients who receive a paracervical block of 5% bupivacaine with epinephrine at the time of laparoscopic myomectomy would have lower postoperative pain, with less consumption of rescue analgesics than patients who receive a paracervical block of normal saline.

Eligibility criteria:
inclusion criteria: * uterine myoma * american society of anesthesiologists physical status (asaps) classification i-ii * the absence of pregnancy at the time of surgery. exclusion criteria: * history of cervical surgery such as conization or cerclage * inability to perform the paracervical block due to anatomical abnormalities (i.e., very atrophic or small cervix) * allergy to bupivacaine, planned concomitant surgical procedures involving extensive additional tissue manipulation such as pelvic lymph node dissection * any concomitant surgery of pelvic floor repair (uterosacral ligament suspension or sacrocolpopexy) or vaginal procedure (anterior or posterior colporrhaphy or mid-urethral slings) * previously taking opioids for chronic pain * inability to accurately express their pain
roflumilast and cognition

Conditions: Dementia

Summary: the aim of the current project is to validate pde4 inhibitors as a target for cognition enhancers (proof-of-concept) using a translational behaviour-eeg approach. the project will demonstrate whether memory, but also attention, information processing or executive function improves with the pde4 inhibitor roflumilast in healthy humans.


Eligibility criteria:
inclusion criteria: * 18 to 35 years of age * healthy (i.e. absence of all exclusion criteria), normal static binocular acuity (corrected or uncorrected), * body mass index between 18.5 and 30 * willingness to sign an informed consent. * positive evaluation on the memory screening exclusion criteria: * history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological, or psychiatric illness * first-degree relative with psychiatric disorder (in particular major depressive disorder and suicidality) * excessive drinking (\>20 glasses of alcohol containing beverages per week) * pregnancy or lactation * use of chronic medication other than oral contraceptives * use of recreational drugs in the 2 weeks preceding participation * smoking * orthostatic hypotension * lactose intolerance * sensory or motor deficits which could reasonably be expected to affect test performance
an international survey on hypoglycaemia among insulin-treated patients with diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of the study is to gather information about hypoglycaemia (low blood glucose) among patients with type 1 or type 2 diabetes mellitus. the study is both retrospective and prospective.


Eligibility criteria:
inclusion criteria: * patients with type 1 or type 2 diabetes mellitus treated with insulin for more than 12 months * patients giving informed consent to participate in the survey exclusion criteria: * non-ambulatory patients * illiterate patients and patients otherwise unable to complete a written survey
impact of preoperative dental screening in reducing infective endocarditis risk in transcatheter aortic valve implantation patients

Conditions: Transcatheter Aortic Valve Implantation; Dental; Endocarditis

Summary: in odense university hospital preoperative dental screening (pds) protocol for patients treated with transcatheter aortic valve implantation (tavi) was changed from mandatory to targeted pds to between june 2023 to october 2023. the investigators will therefore compare the risk of ie before june 2023 and after october 2023.

infective endocarditis (ie), a condition linked with significant mortality and morbidity rates, is particularly concerning for patients with prosthetic left-sided valves. these patients face an elevated ie risk, estimated at about 1% annually in tertiary care settings, cumulatively impacting around one in every 20 patients over a decade. in line with this, both the american heart association (aha) and the european society of cardiology (esc) strongly advocate for the elimination of potential dental sepsis sources at least two weeks before prosthetic valve implantation, except in urgent cases. these guidelines, while not grounded in randomized trials, largely draw upon registry data detailing ie incidence among surgical aortic valve replacement (savr) patients. in a recent study the investigators found no difference in risk of ie when comparing mandatory preoperative dental screening (mpds) with no preoperative dental screening (npds). thus, this prospective registry-based observational before-and-after study aims to investigate the impact of different preoperative dental screening practices on the risk of ie in patients undergoing.

Eligibility criteria:
inclusion criteria: * patients undergoing tavi exclusion criteria: * none

Keywords: transcatheter aortic valve implantation tavi preoperative dental screening infectious endocarditis
the integration of physical activity into the clinical decision process of people with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: every person with type 1 diabetes needs personalized advice to integrate physical activity into daily diabetes management. the purpose of this study is to collect data on food intake, physical activity, glucose levels and insulin delivery from people with type 1 diabetes who are physically active. at least 25 people with type 1 diabetes will be asked to perform 25 sports activities of at least half an hour, wear an activity tracker (day and night) and chest strap (during sports activities), and log data on food intake, periods and type of physical activity, and feelings (e.g., sick, stress) in a diary app. diabetes data such as insulin administration and sensor data will be collected through diabetes management platforms. the primary endpoint involves a database containing data on glucose, insulin administration, physical activity, and food intake of people with type 1 diabetes for statistical analyses and visualizations regarding the relationship between physical activity and blood glucose response.


Eligibility criteria:
inclusion criteria: * signed informed consent * 18-80 years old * type 1 diabetes ≥1 year * using a cgm for more than 6 months * using insulin (insulin pens, insulin pumps or hybrid closed-loop systems) to manage glycaemia for more than 6 months * no use of adjunctive therapies, such as sglt2-inhibitors or glp-1 analogues * no known diabetic gastroparesis * hba1c of the last two diabetes consultations are both \<10% * being physically active at least twice a week on two separate days for 30 consecutive minutes exclusion criteria: * age \ 80 years * people with type 2 diabetes, people with secondary diabetes * begin treatment with insulin (insulin pens, insulin pumps or hybrid closed-loop systems) less than 6 months before inclusion * not using cgm prior to inclusion * known diabetic gastroparesis * hba1c \> 10% during one of the last two diabetes consultations * not willing to use an activity tracker, the diary app or the food app * not being physically active on a regular basis

Keywords: physical activity artificial intelligence
effects of oligo-fucoidan on leiomyoma patients

Conditions: Uterine Leiomyoma

Summary: uterine leiomyoma is the most common benign tumor in women, with an incidence rate of approximately 20% among women of reproductive age. patients may experience severe abdominal pain, abnormal bleeding, and infertility. pathological examination of uterine specimens reveals that up to three-quarters of cases involve uterine leiomyoma, indicating that this condition is often accompanied by other uterine pathologies. therefore, medical intervention remains necessary for affected patients. currently, the most common treatment options include medication and surgical removal. however, the severe side effects of drug therapy and the high recurrence rate following surgical excision significantly impact patients' quality of life, underscoring the need for continued research into better treatment strategies. fucoidan, a commercially available dietary supplement, has been shown in numerous studies to provide adjunctive therapeutic benefits for cancer patients. however, no clinical trials have been conducted to evaluate the effects of fucoidan on patients with uterine leiomyoma. therefore, this clinical study aims to investigate the effects of fucoidan on patients with uterine leiomyoma.


Eligibility criteria:
inclusion criteria: * women with uterine fibroids aged 20-55 years. * confirmation of uterine fibroids by ultrasound (more than 3 cm, less than 10 cm). * there are no plans for pregnancy in the past six months. * there were no plans for uterine fibroid surgery for nearly six months. * agree to abide by the research regulations. exclusion criteria: * a patient with heart disease, liver disease, kidney disease or any mental illness. * patients who are unable to communicate or criticize. * pregnant women. * patients taking regular medications, including serotonin, antidepressants or other antipsychotics. * non-native speakers.
cutting balloon versus non-cutting balloon for the treatment of venous stenosis in the fistulas of hemodialyzed patients

Conditions: Arteriovenous Fistula; Fistula

Summary: the main objective of this study is to evaluate and compare the primary patency rate at 12 months in a group of hemodialysis patients operated on by cutting balloon and in a group of hemodialysis patients operated by conventional balloon.


Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 12 months of follow-up * the patient is on hemodialysis because of chronic renal insufficiency * the patient's vascular access is an arterio-venous fistula * the patient has a venous stenosis in the fistula (first event in the studied zone) * the patient is scheduled for angioplasty exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient cannot fluently read french * the patient cannot understand french * the patient is pregnant * the patient is breastfeeding * short term dialysis * the vascular access is a "graft" * the stenosis in question is a recurrence, and not a first event in the studied zone * the life expectancy of the patient is \< 12 months * medical emergency situation * peritoneal dialysis * at-home dialysis

Keywords: angioplasty cutting balloon
study assessing injection pain of makena® (hydroxyprogesterone caproate injection, 250 mg/ml) when administered via subcutaneous auto-injector vs intramuscular injection via needle and syringe in healthy post-menopausal women

Conditions: Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women

Summary: to demonstrate that makena® (hydroxyprogesterone caproate injection, 250 mg/ml) delivered subcutaneously via auto-injector is associated with less pain as compared to intramuscular injections of makena®


Eligibility criteria:
inclusion criteria: 1. female subjects aged 50 to 75 years of age, inclusive, at screening visit. 2. follicle stimulating hormone (fsh) levels greater than 40 miu/ml. 3. naturally or surgically postmenopausal with or without an intact uterus. exclusion criteria: 1. have history of or positive test results for hiv or hepatitis b or c. 2. a significant history or current evidence of chronic infectious disease, organ dysfunction especially cardiovascular, renal, or hepatic disorders or other medical condition. 3. receiving or have received chronic opioid therapy within 12 months. 4. unwilling to stop taking/using: * pain medication. * topical analgesic or anti-inflammatory treatment. topical analgesics must be washed out by at least 72 hours in the areas to be treated before randomization. 5. history of alcohol abuse (regularly drinks \> 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or prescription/illicit drug abuse in the last 12 months. 6. currently taking any estrogen/progesterone hormone replacement therapy (hrt). 7. history of allergy or sensitivity to hydroxyprogesterone caproate, castor oil or any of the constituents of the study medications or history of any drug hypersensitivity or intolerance. 8. poorly controlled diabetes (hgb a1c \>8). 9. current or history of thrombosis or thromboembolic disorders. 10. known or suspected breast cancer, other hormone-sensitive cancer or tumor, or history of these conditions within the last 5 years. 11. any current or recent (within previous 12 months) vaginal bleeding. 12. uncontrolled hypertension. 13. a chronic pain condition (i.e. chronic back pain) that may confound the assessments of injection pain.
covid-19: a poc test under research & evaluation

Conditions: COVID-19

Summary: collection of nasal/nasopharyngeal/throat swabs and blood samples from patients presenting at their designated care facility displaying symptoms of covid-19 and undergoing a soc sars-cov-2 test or those who have tested positive in the past to aid development, calibration and performance evaluation for the lumiradx poc test.

capture is a two-stage sample collection study to complete the development, calibration and performance evaluation phases of the lumiradx point of care (poc) device for the detection of the sars-cov-2 virus and the sars-cov-2 igg/igm status of infected patients. the study is split into two arms targeting separate populations throughout each stage. stage 1: consists of sample collection only, to facilitate the in-house development and calibration of the lumiradx sars-cov-2 assays. stage 2: consists of sample collection to facilitate the performance evaluation of the lumiradx sars-cov-2 studies. in this stage the testing will be completed onsite using the lumiradx poc device.

Eligibility criteria:
inclusion criteria: 1. patient is at least 18 years of age. 2. patient meets either of the below categories: 1. patient is presenting with symptoms indicative of covid-19 and will be completing soc sampling for sars-cov-2 pcr testing. (eligible for arm a) 2. patient has had a confirmed positive sars-cov-2 pcr test result in the past. (eligible for arm b) exclusion criteria: 1. the patient does not have the capacity to consent as determined by the research team (and the impartial witness if applicable). 2. the patient is deemed to be unsuitable for research at the research teams' discretion.

Keywords: poc ivd sars-cov-2 igg igm antigen antibody
a study of oral ly317615 in relapsed or refractory diffuse large b-cell lymphomas.

Conditions: Non-Hodgkin's Lymphoma

Summary: this study will measure the effectiveness and any side effects of ly317615 in participants with diffuse large b-cell lymphoma (dlbcl: a sub-type of non-hodgkins lymphoma).


Eligibility criteria:
inclusion criteria: * a diagnosis of recurrent or refractory dlbcl. * adequate organ functions. * able to swallow capsules. exclusion criteria: * more than 3 prior treatments for this disease. * serious heart problems.
statin and beta blocker use in patients with decompensated cirrhosis

Conditions: Decompensated Liver Cirrhosis; Cirrhosis; Decompensated Cirrhosis of Liver; Decompensated Cirrhosis and Ascites

Summary: decompensated cirrhosis (liver disease) occurs when liver function decreases to the extent that serious complications develop and can include internal bleeding, fluid buildup in the abdomen, or mental confusion. this reduced decreased liver function subsequently decreases life expectancy. there is a critical need for strategies to delay progression to decompensation and reduce the occurrence of serious complications. currently, limited therapeutic options are available for managing decompensated liver disease, with beta-blockers (bb) being the only proven medication with significant benefits in preventing disease progression. statins have been historically under- prescribed in cirrhosis due to concerns of liver damage. however, there is emerging evidence that statin use may be beneficial and able to lessen liver disease worsening, with studies demonstrating its safety. thus, we aim to conduct a pilot randomized controlled trial (rct) study of 50 subjects comparing the outcomes of decompensated cirrhotic patients receiving the statin, atorvastatin, and a non-selective beta-blocker (nsbb) versus those receiving nsbb plus placebo. both groups will be followed for 12 months to investigate the feasibility, safety, and efficacy of combination therapy.


Eligibility criteria:
inclusion criteria: * patients age of 18 years or older diagnosed with any form of decompensated liver disease defined as ascites, hepatic encephalopathy, or variceal bleed presenting at charleston area medical center (camc) memorial hospital or camc-gastroenterology liver clinic * currently on an non-selective beta-blockers agreeing to have their liver disease managed by camc-gastroenterology liver clinic as an outpatient for the 12-month follow-up period. exclusion criteria: * any patient \<18 years of age * patients with hepatocellular carcinoma * patients with ongoing alcohol use (self-reported consumption of more than one alcoholic drink per week) * patients exhibiting high-risk behaviors that could put them at risk for complications including iv substance use and history of medication non-adherence * patients currently on statin therapy * patients with a history of statin intolerance * patients on the waitlist for liver transplantation * patients taking medications with known drug interactions with statins * patients not able to give informed consent or patients belonging to vulnerable categories as the federal regulations or common rule

Keywords: decompensated cirrhosis decompensated liver disease statins beta-blockers cirrhosis
serum trap-5b levels in patients with generalized chronic periodontitis

Conditions: Chronic Periodontitis

Summary: to compare the effect of non-surgical periodontal therapy with or without systemic administration of amoxicillin and metronidazole on the concentration of serum levels of trap-5b in patients with generalized chronic periodontitis.

30 chronic periodontitis subjects were divided into two groups- group a underwent scaling and root planing and group b underwent scaling and root planing with systemic administration of amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days. periodontal parameters probing pocket depth and clinical attachment level were measured at baseline and at 3rd month. serum trap-5b levels were also measured at baseline, 1 month and at 3rd month.

Eligibility criteria:
inclusion criteria: * presence of atleast 20 teeth * more than 30% of sites with clinical attachment loss of ≥ 5 mm * non-smokers * no previous history of periodontal therapy exclusion criteria: * systemic diseases * under antibiotics or anti-inflammatory drugs within previous 3 months * pregnant and lactating women * allergic to antibiotics

Keywords: chronic periodontitis trap-5b non-surgical periodontal therapy systemic antibiotics
a trial to assess the effect of delgocitinib cream 20 mg/g on the molecular signature, safety, and efficacy in adults with frontal fibrosing alopecia

Conditions: Frontal Fibrosing Alopecia

Summary: this purpose of this trial was to investigate the molecular signature of frontal fibrosing alopecia (ffa) and the effect of delgocitinib cream 2% on reversing the ffa disease signature in active lesions. the trial also investigated the clinical effect of delgocitinib cream on ffa compared to a placebo cream.


Eligibility criteria:
inclusion criteria for group 1 only (subjects with ffa): 1. male or female subject aged 18 years of age or older at the time of consent. 2. subject has clinically confirmed diagnosis of ffa. 3. subject has a target area with a perifollicular erythema score ≥ 2 and a perifollicular scale score ≥ 2 at screening and day 1. for group 2 only (healthy subjects): 1. female subject aged 45 years of age or older at the time of consent. 2. female is postmenopausal. 3. subject is in good general health. exclusion criteria for all subjects: 1. subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial. 2. presence of hepatitis b or c infection or hiv infection at screening. for group 1 only (subjects with ffa): 1. history of other scalp/hair disease including discoid lupus erythematosus and central centrifugal cicatricial alopecia. 2. subject who has undergone scalp reduction surgery or hair transplantation. 3. subject is known to have immune deficiency or is immunocompromised. 4. subject has used intralesional scalp corticosteroids or platelet rich plasma injection in the last 4 weeks prior to randomization. 5. subject has used systemic treatment with immunosuppressive/modulating medication or medication within 4 weeks prior to randomization. 6. subject has used any topical medicated treatment that could affect ffa within 2 weeks prior to randomization. 7. subject has received any phototherapy within 4 weeks prior to randomization. for group 2 only (healthy subjects): 1. subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the trial assessments. 2. subject has used a topical medicated treatment on the targeted skin sites within 2 weeks prior to trial assessments.