Kornimate/medical-research-clean huggingface dataset:
photodynamic therapy using hpph in treating patients with dysplasia, cancer in situ, or invasive cancer of the larynx

Conditions: Head and Neck Cancer

Summary: rationale: photodynamic therapy uses a drug, such as hpph, that becomes active when it is exposed to a certain kind of light. when the drug is active, tumor cells are killed. this may be an effective treatment for laryngeal cancer. purpose: this phase i trial is studying the side effects and best dose of laser light therapy when given together with hpph in treating patients with dysplasia, cancer in situ, or invasive cancer of the larynx.

objectives: primary * to determine the maximum tolerated dose of laser light therapy using a fixed dose of hpph in patients with dysplasia, squamous cell carcinoma in situ, or t1 squamous cell carcinoma of the larynx. secondary * to determine response in patients treated with this regimen. outline: this is a dose-escalation study of laser light therapy. patients undergo photodynamic therapy comprising hpph iv over 1 hour on day 1 and laser light therapy to the tumor on day 2. approximately 8 weeks later, patients with a partial response, no response, or a geographical miss may receive a second course of treatment. after completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then periodically thereafter.

Eligibility criteria:
disease characteristics: * biopsy-confirmed diagnosis of 1 of the following: * mild to severe dysplasia of the larynx * dysplastic lesions \> 3 mm in thickness * squamous cell carcinoma in situ of the larynx * t1 squamous cell carcinoma of the larynx * tumor \> 3 mm in thickness * no t2-t4 squamous cell carcinoma of the larynx * newly diagnosed or recurrent disease patient characteristics: * ecog performance status 0-2 * total bilirubin \> 2.0 mg/dl * creatinine \> 2.0 mg/dl * sgot \> 3 times upper limit of normal (uln) * alkaline phosphatase \> 3 times uln * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 3-6 months after completion of study treatment * no porphyria * no hypersensitivity to porphyrin or porphyrin-like compounds prior concurrent therapy: * any prior therapy allowed * at least 4 weeks since prior and no concurrent chemotherapy or radiotherapy

Keywords: recurrent squamous cell carcinoma of the larynx stage i squamous cell carcinoma of the larynx stage iii squamous cell carcinoma of the larynx stage iv squamous cell carcinoma of the larynx stage 0 laryngeal cancer
inulin supplementation during sanative therapy to further improve periodontal healing

Conditions: Periodontitis; Periodontal Diseases; Periodontal Pocket

Summary: the aim of this study is to investigate the effectiveness of daily supplementation with inulin before, during and after sanative therapy (st), on clinical outcomes of periodontal disease. the study design will allow the investigators to conclude if supplementation with inulin can favourably modulate oral microbiota prior to st and can result in better periodontal health after st.

periodontal disease is a chronic state of inflammation that can destroy the supporting tissues around the teeth, leading to a loss of connective tissue and the periodontal ligament, the resorption of alveolar bone and eventual tooth loss. periodontal disease can also induce dysbiosis in the gut microbiome and contribute to low grade systemic inflammation. prebiotic fibres such as inulin can selectively alter the intestinal microbiota to bring back a state of homeostasis by improving gut barrier functions and preventing inflammation. through this mechanism, supplementation with inulin may be able to indirectly benefit periodontal health. the primary objective of this trial to determine if inulin supplementation, provided pre-sanative therapy (st) through the healing phase (post-st) is more effective than the placebo at improving clinical outcomes of periodontal health: decreasing both the number of sites with probing depths greater than or equal to 4 mm and increasing the absence of bleeding on probing (bop). secondary objectives include determining the effects of inulin supplementation pre- and post-st on salivary markers of inflammation and periodontal-associated pathogens.

Eligibility criteria:
inclusion criteria: * both males and females age 19 years or older who are undergoing sanative therapy for moderate to severe chronic periodontitis are eligible * provided informed, written consent exclusion criteria: * patients with severe periodontal disease that requires antibiotics with st as part of their treatment * hemoglobin a1c levels greater than 8% in the previous 3 months * chronic gi conditions and/or infections (e.g. colon cancer, crohn's disease, inflammatory bowel disease, celiac disease and ulcerative colitis) * current or previous use of antibiotics for management of non-periodontal conditions within the past 3 month * current use of laxatives, prebiotics, probiotics and/or fibre supplements * smokers and/or cannabis users * pregnant or breast-feeding

Keywords: sanative therapy scaling and root planing
copeptin in the differential diagnosis of dysnatremia in hospitalized patients

Conditions: Hyponatremia; Hypernatremia

Summary: background: hypo- and hypernatremia are common in hospitalized patients. the differential diagnosis of dysnatremia is challenging. osmotically inadequate secretion of antidiuretic hormone (adh) is the predominant mechanism in most dysnatremic disorders. adh measurement is cumbersome. it is derived from a larger precursor peptide along with copeptin, which is a more stable peptide directly mirroring the production of adh. objective: to evaluate the additional value of copeptin to improve a currently used algorithm in the differential diagnosis of (a) severe hypoosmolar hypo- and (b) severe hypernatremia. design: prospective observational study.


Eligibility criteria:
inclusion criteria: * hyponatremia \ 155 mmol/l exclusion criteria: * no informed consent

Keywords: hyponatremia hypernatremia
interest in "combo" (a combination of dietary supplements including probiotics) in nash improvement

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: the aim of this bicentre, prospective, placebo-controlled, double-blind, randomized, interventional study is to assess for the first time the effects of a combo with probiotics and dietary supplements compared to placebo for non-alcoholic steatohepatitis (nash) patients with mild or severe fibrosis.

liver-related mortality is increased 10-fold in nash patients compared with the general population. currently, there are no established pharmacotherapies for nash patients. the gut microbiota has a major contributing role in the development of nash with leaky gut, inflammation, oxidative stress and impaired microbiota. restoring the microbiota symbiosys could be a new way of resolution of nash. the aim of this trial is to evaluate the efficacy of the combo, association of probiotics (lactobacillus rhamnosus gg, bifidobacterium breve br03, lactobacillus plantarum) and glutamine, quercetin, vitamin e, curcumin, silybin, pectin by means of histological resolution of nash without progression of fibrosis, after 26 weeks (6 months), in 60 nash patients with mild to severe fibrosis. to confirm a histological diagnosis of nash and proof efficacy of the combo, a liver biopsy will be performed prior to screening as well as at the end of supplemental phase

Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe nash : * chronic liver disease: biological abnormalities for more than 6 months characteristic ultrasound aspects * metabolic syndrome * liver stiffness assessed by fibroscan between 8 and 15kpa * adults * affiliated to a social security * women using effective contraception (hormonal or mechanical) for the duration of the srudy exclusion criteria: * pregnancy * excessive alcohol consumption (\>100g/week) * cirrhosis (elastometry \> 15kpa) * hepato-cellular carcinoma * hepatitis from corticosteroids, methotrexate, amiodarone, tamoxifen * viral hepatitis * auto immune hepatitis * anticoagulant therapy * antibiotics in the month prior to inclusion * allergic to soya, aspirin, fish, e110 dye, maltodextrin * poorly controlled diabetes (glycated hemoglobin \>8%) * inclusion in a drug interventional trial

Keywords: combo liver stiffness gut microbiota dietary supplements
giessen pulmonary hypertension in lung cancer registry

Conditions: Pulmonary Hypertension Due to Lung Diseases and Hypoxia

Summary: the aim of this study is to investigate the frequency and implications of pulmonary hypertension in lung cancer patients. to do so, data will be collected from all lung cancer patients at the university hospital giessen. all data will be analyzed for possible hints of pulmonary hypertension as a comorbidity in lung cancer patients. all information will be generated from the regular guidelines based course of treatment and there will be no interventions. this study will serve as a prospective register for all lung cancer patients treated at the university hospital giessen.


Eligibility criteria:
inclusion criteria: * patient with lung cancer at the university of giessen lung cancer center. exclusion criteria: -
the prophylactic role of tranexamic acid in high risk pregnant women undergoing elective cesarean section in prevention of postpartum hemorrhage

Conditions: High Risk Pregnant Women Undergoing Elective Cesarean Section

Summary: the aim of the study is to assess the prophylactic role of tranexamic acid in reducing blood loss during and after elective cesarean section delivery in high risk patients. comparing effect of administration of 1gm of txa half an hour before elective c-section , effect of administration of 1gm of txa on the start of uterine incision and placebo effect, where in all an addition of prophylactic uterotonics is given, in a randomized control, double blind trial of 3 groups.

all patients will undergo the following i. history : medical history, obstetric history, comorbidities, allergies. ii. clinically: vital signs, abdomino-pelvic examination, per-vaginal examination. iii. laboratory: hemoglobin, hematocrit before \& after cesarean section. iv. routine ultrasound. v. cesarean section: done under spinal anathesia. vi. calculation of blood loss: the quantity of blood loss (ml) is calculated from 3 components : * (weight of used towels during surgery - weight of used towels prior to surgery),plus * (volume of blood sucked in suction container after placental delivery) ,plus * (weight of used vaginal pad in the first 2 hours after cs - the pad' s dry weight) * each 1 mg increase the weight of either the towels or the vaginal pads is equivalent to 1 ml blood loss (vitello, dominic j., et al). vii. informed consent: will be obtained from all participants including the pregnant women who are included in the study . all patients will receive routine ecbolics ( oxytocin ) after delivery of baby.

Eligibility criteria:
inclusion criteria: * high risk women undergoing elective c-section * hypertensive patients. * obese patients. * patients on lmwh. * transverse lie * dm ( type 1 \& gestational ) * cardiac ( not on anticoagulants ) * placenta previa ( not in pas ) * previous uterine scar ( \> previous 2 c- section ) exclusion criteria: * patients with bleeding tendency. * hellp syndrome. * emergency c- section. * mechanical prosthetic valve * atrial fibrillation. * allery to tranexamic acid * placenta accreta , increta , percreata.

Keywords: high risk pregnancy cesarean section. tranexamic acid
risk of cancer among pantoprazole users

Conditions: Esophagitis

Summary: the primary objective is to assess whether the risk of gastric cancer is increased in pantoprazole users compared to users of other proton pump inhibitors.

all subjects who met the inclusion criteria were included in the study.

Eligibility criteria:
inclusion criteria: * patients who have used pantoprazole or other proton pump inhibitors, enrollment in the health maintenance organization for at least 6 months, age 18 years or older. exclusion criteria: * use of any proton pump inhibitor before study entry, any cancer diagnosis recorded in the medical history, diagnosis of zollinger-ellison syndrome in medical history.

Keywords: pantoprazole proton pump inhibitor gastric cancer digestive system cancer cancer
valganciclovir to treat hhv-8 associated multicentric castleman's disease

Conditions: Giant Lymph Node Hyperplasia

Summary: the purpose of the study is to learn whether people who are experiencing an mcd (multicentric castleman's disease) flare will improve after taking valganciclovir. mcd is a type of inflammatory disease associated with human herpesvirus 8 (hhv-8). valganciclovir is fda approved for treating a different type of human herpesvirus, but not approved for the treatment of hhv-8. it is therefore considered experimental in this study.

all participants will undergo an initial screening appointment. at this visit, participants will be tested for human herpesvirus 8 (hhv-8), the virus that is associated with mcd, and we will review participants' medical history and medical records to determine whether he/she has mcd. if participants do not live within the seattle area, this visit may occur over the phone. those who qualify for the study will be followed for up to 2 years. during that 2 year period, participants will be asked to collect oral swabs once a week and have blood drawn monthly. if subjects do not live within the seattle-area, they will be asked to ship these samples to uw for testing. we will provide subjects with instructions for these shipments. this will be done at no cost to the participant. if during the 2 year period the participant experiences a mcd flare, he/she will be admitted to the university of washington medical center's clinic research center for 14-days. if the participant does not live within the seattle-area, all travel expenses will be covered. the study will enroll a total of 8 patients who will receive open-label valganciclovir for 14-days. everyday during the hospitalization, participants will have blood drawn (to check your hhv-8 levels), 1 oral swab will be collected and a general physical exam will be performed.

Eligibility criteria:
inclusion criteria: * age 18 years * negative pregnancy test (for female participants) * diagnosis of mcd for over one year, with a history of at least one mcd recurrence annually * evidence of infection with hhv-8 * a willingness to travel and reside temporarily in seattle for completion of the study protocol. * for hiv-infected participants, a stable antiretroviral regimen for the past 6 months exclusion criteria: * concurrent kaposi sarcoma or non-hodgkin's lymphoma * a history or evidence of cmv disease * hypersensitivity to ganciclovir or valganciclovir * use of high-dose acyclovir (\>800 mg bid), valacyclovir (\>1000 mg qd) or famciclovir (\>1000 mg qd), ganciclovir, foscarnet, or cidofovir * neutropenia (anc \<1500) * renal insufficiency with serum creatinine \> 1.5 mg/ml or crcl \< 60 * ast or alt \> 5 times upper limit of normal * concurrent administration of medications which are often associated with severe neutropenia or thrombocytopenia (i.e., chemotherapy, etc) * concurrent administration of probenecid or didanosine. * inability to read and understand english
comparison of the shukla and un-1 formulae in the placement of the umbilical venous catheter among neonates

Conditions: Extreme Prematurity,Extremely Low Birthweight; Extremely Low Birth Weight; Very Low Birth Weight Infant; Neonatal Hypoglycemia

Summary: umbilical vein catheters (uvc) are commonly inserted in newborns especially neonates admitted to the neonatal intensive care unit (nicu).these catheters are used since 1959. it is a suitable method for parenteral nutrition access and medications administration. despite the benefits of the uvc, its potential complications must be considered. thus, it is vital to determine the appropriate penetration length of the uvc.

uvc insertion has benefits and potential complications such as infection, intestinal necrosis, thrombosis, ascites, hydrothorax, cardiac tamponade, cardiac arrhythmias, pleural effusion, pericarditis and pericardial effusion. the complications may be due to insertion of catheter in an inappropriate location. imaging procedures such as plain thoracoabdominal x-ray is needed after catheter insertion to specify the location of the catheter tip. in addition to preventing complications, insertion of umbilical venous catheter in an appropriate location is essential for umbilical catheterisation effectiveness. there are different methods to determine the length of catheter which must be inserted in umbilical vessels. the uvc formulae are based on either body surface measurement such as dunn method, umbilical to intermammary distance (uimd), umbilical to nipple distance (un)-1 and birthweight based formula method such as shukla and modified shukla. shukla and un-1 methods have been widely used in the world. however, the accuracy of these two methods in estimating the length of umbilical venous catheter has not still demonstrated.

Eligibility criteria:
inclusion criteria: * all term and preterm newborns requiring uvc insertion will be included in the study. exclusion criteria: * all neonates with major congenital malformations that interferes with the placement of the uvc will be excluded.
tracking encapsulation of pancreatic collections in acute necrotizing pancreatitis

Conditions: Acute Necrotizing Pancreatitis

Summary: the goal of this study is to investigate the encapsulation of fluid collections in patients with anp using serial mri. the main questions it aims to answer are: * evaluating the timing of encapsulation of necrotic fluid collection using serial non-enhanced mri. * identifying the factors that affect the timing of encapsulation of necrotic fluid collections participants will undergo serial mri scans (all with the same protocol) performed starting at day 15. subsequent scans will be performed at 5 days interval till the clinically significant encapsulation (for all the collections in an individual patient) is seen or patients are excluded from the protocol due to intervention.

consecutive patients with anp presenting to the hospital within 2 weeks from the pain onset will be recruited. they will undergo serial non-contrast mri starting at day 15 and every 5 days thereafter, till complete encapsulation of pfc. ultrasound evaluation of the collection will be performed on the day of mri by a radiologist not involved in evaluation of mri. the site and volume of collection as well as thickness and completeness of the capsule and solid content within the collection will be recorded independently by two radiologists. the timing of clinically significant (\>50% of pfc show capsule) and complete encapsulation will be recorded. the proportion of collections encapsulating in each week after 2nd week of illness will be recorded. the association between timing of encapsulation and clinical/biochemical parameters will be assessed. the correlation between the degree of encapsulation and percentage of solid components will also be documented. multivariate analysis will be performed to identify factors associated with timing of encapsulation.

Eligibility criteria:
inclusion criteria: 1. acute necrotizing pancreatitis 2. presentation to hospital within 2 weeks of pain onset 2. willing to give informed consent exclusion criteria: 1. contraindications to non- enhanced mri (claustrophobia, cardiac pacemaker, cochlear implant). 2. acute on chronic pancreatitis 3. mechanical ventilation, ionotropic support (precluding safe environment in mri). 4. drainage or aspiration of a collection prior to recruitment

Keywords: acute pancreatitis,necrotic collections,walled off necrosis
rw effectiveness of lurbinectedin in extensive stage sclc

Conditions: Small-cell Lung Cancer

Summary: lurbiclin cohort will describe the demographic and clinical characteristics of patients who received at least one dose of lurbinectedin as part of atu program. lurbiclin will evaluate effectiveness and safety of lurbinectedin in real-world conditions.

lurbiclin cohort will describe the demographic and clinical characteristics of patients who received at least one dose of lurbinectedin as part of atu program. lurbiclin will evaluate overall survival, real world progression-free survival, best response and duration of treatment in patients with advanced, metastatic small cell lung cancer (sclc) who received lurbinectedin as part of the french early access program (atu). previous and subsequent treatments (treatment delivered immediately after treatment with lurbinectedin) will be recorded. those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.

Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically confirmed extensive stage small cell lung cancer * patients who were informed about the study and accepted for their data to be collected * patients who received at least one dose of treatment with lurbinectedin as part of the french early access program (atu program). * selection period spans from june 2020 until march 2021 for initiation of treatment with lurbinectedin. exclusion criteria: * patients enrolled in a clinical trial assessing treatment with lurbinectedin

Keywords: ifct small-cell lung cancer lurbinectedin real-world study
an open-label, single center trial to assess the pharmacokinetics, pharmacodynamics and safety of org 36286 (p07004)

Conditions: Infertility

Summary: the objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety of org 36286 after a single subcutaneous administration in healthy females.


Eligibility criteria:
inclusion criteria: * good physical and mental health; * body mass index between 18 and 29 kg/m\^2; * good venous accessibility; exclusion criteria: * clinically relevant abnormal blood chemistry, hematology and/or urinalysis at screening; * hypertension (sitting diastolic blood pressure \> 90 mmhg and/or systolic blood pressure \> 150 mmhg); * contraindications for the use of oral contraceptives or gonadotropins; * pap-smear (= iii) according to the papanicolaou classification; * history of endocrine abnormalities such as hyperprolactinaemia, polycystic ovary syndrome or any evidence of ovarian dysfunction; * primary ovarian failure; * ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease; * any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation; * ovarian surgery; * smoking more than 10 cigarettes or equivalents a day; * history (within 12 months) of alcohol or drugs abuse; * blood donation (\> 200 ml) within 90 days prior to screening; * administration of investigational drugs within 90 days prior to start org 36286.

Keywords: females corifollitropin alfa antibodies pharmacokinetics pharmacodynamics