cyrilzakka/clinical-trials huggingface dataset:
Oxytocin Pharmacokinetics and Pharmacodynamics

Oxytocin is the first-line drug to promote contraction of the uterus and prevent atony immediately after delivery. Nonetheless, unpredictable uterine atony refractory to oxytocin affects roughly 250,000 parturients annually in the U.S. and rates are increasing. This two-part study will measure the action of oxytocin at cesarean delivery. The first part will measure the pharmacokinetics of a single intravenous (IV) dose of deuterium-labeled oxytocin. The second part will measure the pharmacodynamics of all plasma oxytocin to see how concentrations correspond to the contractile effect on the uterus.

After delivery of the fetus, study subjects will receive a bolus of IV deuterated oxytocin followed by an unlabeled oxytocin infusion. Venous blood samples drawn at multiple time points (within 1 hour after delivery) will be analyzed for plasma concentrations of labeled and unlabeled (endogenous + exogenous infused) oxytocin over time. Plasma concentrations will be compared with 0-10 uterine tone scores measuring uterine contraction strength, to describe the concentration-effect relationship.

The goal of this study is to define both the pharmacokinetics and pharmacodynamics of oxytocin in parturients to help identify the cause(s) of failed first-line oxytocin therapy.

Parturients aged 18-50 with an intrauterine term pregnancy (37 weeks or greater) undergoing non-emergent cesarean delivery at the University of Chicago (UC) and Stanford University will be recruited.

Methods: All subjects will receive standard pre-, intra- and postoperative care for their cesarean delivery with additional study interventions.

Study subjects will have an additional intravenous (IV) catheter inserted for intra-operative study-related blood draws.

A single, 1 International Unit (IU) bolus of deuterated oxytocin (d5OT) will be given to the subject, followed by an infusion of standard protocol oxytocin immediately after placental delivery. IV samples will be drawn from the study IV at 0, 1, 2.5, 5, 10, 20, 30, 45, 60 minutes following administration of the study drug. The samples will be processed, batched and shipped to the central lab being used in this study. Uterine tone scores will be measured simultaneously with blood draws until accurate palpation is no longer possible. Uterine tone score is a 0 to 10 numeric rating scale with 0 to describe unsatisfactory or no uterine tone and 10 to describe perfect uterine tone.

Eligibility Criteria:
Inclusion Criteria

* 18-50 years old
* intrauterine pregnancy
* term (\>39 weeks gestation or 37-39 weeks gestation with fetal or maternal medical indication for delivery) pregnancy
* non-emergent (scheduled or unscheduled) cesarean delivery

Exclusion Criteria:

* allergy or contraindication to oxytocin
* inability to provide informed consent
Study of the Impact of a Physical Activity Programme on the Quality of Life of Patients With Inflammatory Bowel Disease

Regular physical activity at a mild to moderate intensity can control inflammation in general and intestinal inflammation in particular during IBD. The effectiveness of a physical activity programme has been evaluated during IBD, but the data are limited to a few studies. Overall, PA improves quality of life but also improves control of disease symptoms and fatigue . The aim of the present work is to evaluate the impact of a physical activity programme on quality of life in patients with IBD. This programme will also evaluate the impact of physical activity on 1) anxiety-depression, 2) fatigue (a frequent and difficult to manage symptom in IBD), 3) IBD activity, 4) smoking cessation.

Crohn's disease and haemorrhagic rectocolitis are Chronic Inflammatory Bowel Diseases (CIBD) which evolve by flare-ups interspersed with periods of remission . The incidence of these two diseases is increasing in France in adults but also and especially in children and adolescents. Indeed, according to data from the EPIMAD registry, from 1988-1990 to 2009-2011, a significant increase in the incidence of both Crohn's disease and haemorrhagic rectocolitis was observed in adolescents (10-16 years): for Crohn's disease from 4.2 to 9.5/10 5 (+126%; P \<0.001) and for UC from 1.6 to 4.1/10 5 (+156%; P \<0.001). Over the long term, Crohn's disease can progress to intestinal destruction that can be complicated by stricture(s), obstruction(s), fistula(s) and/or abscesses leading to surgical treatment estimated at 50% after 10 years of Crohn's disease progression 1.

Anti-TNFα therapies are widely prescribed for Crohn's disease because they control symptoms, heal the mucosa, reduce hospital admissions and improve quality of life. However, they are associated with side effects often reported by patients, such as asthenia, weight gain and joint pain, symptoms that could be improved by regular physical activity.

Regular physical activity at a mild to moderate intensity can control inflammation in general and intestinal inflammation in particular during IBD. The effectiveness of a physical activity programme has been evaluated during IBD, but the data are limited to a few studies. Overall, PA improves quality of life but also improves control of disease symptoms and fatigue . The aim of the present work is to evaluate the impact of a physical activity programme on quality of life in patients with IBD. This programme will also evaluate the impact of physical activity on 1) anxiety-depression, 2) fatigue (a frequent and difficult to manage symptom in IBD), 3) IBD activity, 4) smoking cessation.

Eligibility Criteria:
Inclusion Criteria:

* Patient followed for IBD in the hospital of Montfermeil
* over 18 years of age
* medical certificate authorising the practice of physical activity
* Informed consent

Exclusion Criteria:

* Age \< 18 years
* Medical contraindication to physical activity
* Objection to participation in this study
Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

The primary objective of the open-label, dose-escalation study is to investigate the safety of single-dose monotherapy and repeated-dose of KHK2375 combined with exemestane in female subjects with advanced or recurrent breast cancer. The secondary objective is to investigate the pharmacokinetics and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women aged ≥ 20 and \< 75 years at the time of consent;
* Estrogen receptor positive and/or progesterone receptors positive;
* HER2-negative
* Nonresectable advanced or recurrent breast cancer previously treated with nonsteroidal aromatase inhibitor (AI), and planning to be treated with exemestane

Exclusion Criteria:

* Radiation therapy or immuno therapy within 14 days before the first dose of investigational product;
* Chemotherapy, biological medicines, other pharmacotherapy or major surgery within 21 days before the first dose of the investigational product;
* Prior chemotherapies of ≥ 3 regimens for advanced or recurrent breast cancer;
* Ongoing treatment with other investigational product
Peritoneal Dialysis vs Furosemide for Acute Kidney Injury After Cardiopulmonary Bypass

Acute kidney injury (AKI) after cardiopulmonary bypass (CPB) in infants is common and associated with poor outcomes. Peritoneal dialysis (PD) and furosemide have been used to attain negative fluid balance due to AKI induced oliguria, but have not been compared prospectively. The investigators will prospectively compare outcomes of infants with oliguria after CPB randomized to PD vs. furosemide with the hypothesis that infants receiving PD have superior outcomes.

Background: Acute kidney injury (AKI) is a common postoperative complication after heart surgery with cardiopulmonary bypass (CPB). Multiple studies have demonstrated that patients with AKI have worse clinical outcomes, such as longer ventilation times and increased length of stay, which is thought to be secondary to associated oliguria and subsequent fluid overload. Studies suggest that early renal replacement therapy (RRT) via peritoneal dialysis (PD) may prevent fluid overload and therefore be a superior management to diuretic (i.e. furosemide) administration. However, there is no published evidence to suggest superiority or laboratory data available to guide decision making.

Objective: Our primary objective is to determine if early institution of PD improves clinical outcomes compared to administration of furosemide in post-operative cardiac infants with acute kidney injury. We hypothesize that early initiation of PD will improve clinical outcomes. We will determine if these clinical outcomes will be better among good responders of furosemide compared to poor responders. We will determine if postoperative NGAL concentrations are predictive of poor response to furosemide.

Design / Methods: The study will be a single-center randomized clinical trial among neonates undergoing cardiac surgery with CPB with planned placement of a PD catheter due to risk of AKI. If patients demonstrate oliguria within the first postoperative day, they will be randomized to early PD or trial of furosemide. Clinical and laboratory data will be collected and compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Age less than 6 months of age;
* Undergoing cardiothoracic surgery with CPB;
* Planned placement of PD catheter per institutional standard of care criteria.

Exclusion Criteria:

* Pre-existing chronic kidney disease stage 3 or above (correlating with estimated GFR\<60 ml/min/m2, which will be calculated using routine preoperative serum creatinine value using the modified Schwartz equation).
* Known history of allergy to furosemide.
Evaluation of the Absorption Rate From Different Oral Fe-supplements in Obese Volunteers Pre- and Post-RYGB

Obese volunteers who have scheduled a gastric bypass (RYGB) in UZ Leuven will be asked to participate in a cross-over study using commercial available iron supplements. The aim of this study is to evaluate the absorption rate of different oral iron supplements in volunteers before and after RYGB (1, 3, 6 and 12 months post-RYGB).

Patients who met the criteria will be invited to come to the clinical research center at 10 occasions (two times before and 1, 3, 6 and 12 months after RYGB). During each visit the following information will be collected:

* General information concerning sociodemographic and medical background
* The medical history
* Anthropometric measures
* Physical activity by questionnaire
* Food frequency by questionnaire
* Information about menstrual blood loss.

Following an overnight fast, subjects will come to the clinical research center. An intravenous catheter will be inserted to collect blood samples. Before the oral administration, blood samples will be collected for the determination of the serum concentration of different iron status markers. The volunteers will receive first an iron(II)sulfate supplement, followed by a Fe-chelate supplement (at least 7 days between both supplements). After the administration of the supplement, blood samples will be taken at various time points to determine the amount of iron absorption and to investigate if there are any changes in the iron metabolism (at 15, 30, 60, 90 minutes and 2; 2.5; 3; 3.5; 4 and 5 hours after oral administration). There will be a one-week washout period between the tests with each iron supplement. The volunteers will be asked to repeat the test before surgery and 1, 3, 6 and 12 months after surgery for each iron supplement.

Eligibility Criteria:
Inclusion Criteria:

* Obese patients who have planned a RYGB surgery in the University Hospital Leuven
* Low iron status at the preoperative consultation (ferritin \< 30 µg/L and/or transferrin saturation \<20%)

Exclusion Criteria:

* Patients with a bariatric surgery history
* Smokers (\> 15 cigarettes/day)
* Pregnant women
* Lactating women
* Patients with a positive helicobacter pylori screening
INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers

Previous studies have indicated increased vasopressin due to hypertonic saline infusion impairs glucose regulation. The current study will examine the effect of low water intake on glucose regulation. No currently published study has investigated the acute effect of low water intake on glucose regulation using continuous glucose monitoring over the course of a full day. The aim of the study is to observe the effect of low water intake on glucose regulation in low drinkers. The study will study the glycemic responses to standardized meals in adults during an 11-hour period in two conditions: a) high water intake and b) low water intake. It is hypothesized that the area under the glucose curve will be greater in the low water intake trial as compared to the high water intake trial


Eligibility Criteria:
Inclusion Criteria:

* healthy sedentary participants
* aged 30-55 years
* body mass 27.5-35.0 kg·m2
* low water intake less than 1.5 L∙day-1 (male) or 1.0 L∙day-1 (female)
* 24 h urine osmolality greater than 800 mmol/kg

Exclusion Criteria:

* diabetes HbA1c \>6.5%
* impaired liver or kidney function
* cardiovascular disease
* weight change of more than 3 kg in the past month
* pregnancy
* previous surgery on digestive tract
* exercise \>4 h/week
Comprehensive Nutritional Geriatric Assessments in Identifying Malnutrition in Older Cancer Participants

This trial studies how well comprehensive nutritional geriatric assessments work in identifying malnutrition in older cancer participants. Comprehensive nutritional geriatric assessments may help doctors learn about ways to check for malnutrition (loss of weight/appetite that may result in health problems) that is due to cancer or cancer treatment.

PRIMARY OBJECTIVES:

I. To evaluate whether nutritional status, as determined by each of 4 screening tools (Mini Nutritional Assessment \[MNA\], weight loss, body mass index \[BMI\], and lean muscle mass), correlates with 6-month and 12-month mortality in older cancer patients after geriatric assessment, after adjusting for covariates.

II. To evaluate whether nutritional status, as determined by each of by 4 screening tools (MNA, weight loss, BMI, and lean muscle mass) correlates with 6-month and 12-month unplanned hospitalization in older cancer patients who undergo geriatric assessment, after adjusting for covariates.

III. To evaluate whether nutritional status, as determined by each of 4 screening tools (MNA, weight loss, BMI, and lean muscle mass) correlates with 6-month and 12-month hospital readmissions in older cancer patients who undergo geriatric assessment, after adjusting for covariates.

OUTLINE:

Participants undergo nutritional geriatric assessment over 15 minutes in person or on the phone every 3 months for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* With hematologic and solid tumor cancers.
* Undergo a comprehensive geriatric assessment by a geriatrician.

Exclusion Criteria:

* Unable or unwilling to sign consent form.
* Life expectancy under 6 months.
Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors

Rationale: Survivors of childhood cancer are at an increased risk of developing cardiovascular risk factors as well as early cardiovascular disease, likely due to the intensive therapeutic regimen used to treat their cancer. Purple grape juice (PGJ) is a rich source of flavonoids and a powerful antioxidant. Clinical studies in both diseased and healthy adults suggest that daily consumption of PGJ contributes to increased antioxidant capacity, reduced low-density lipoprotein (LDL) oxidation, and improved vasodilation.

Purpose: This randomized clinical trial is evaluating whether purple grape juice can reduce oxidative stress and improve the vascular health of survivors of childhood cancer in the early stages of cardiovascular disease.

Primary Objective:

* To evaluate the effect of PGJ on endothelial function, a key measure of vascular health and considered a barometer for cardiovascular disease risk.

Secondary Objective:

* To evaluate the effect of PGJ on biomarkers of vascular and systemic oxidative stress.

Outline:

Patients undergo a 4-week washout period and refrain from consuming any type of juice, juice drink (less than 100% juice), wine or grapes. Patients are then randomized to 1 of 2 arms.

Arm 1: Beginning in week 4, patients consume 6 ounces of purple grape juice (PGJ) twice daily for 4 weeks. Beginning in week 12, after a 4 week washout period, patients crossover to consume apple juice (AJ) as in Arm 2.

Arm 2: Beginning in week 4, patients consume 6 ounces of AJ twice daily for 4 weeks. Beginning in week 12, after a 4 week washout period, patients crossover to consume PGJ as in Arm 1.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cancer \> 5 years ago
* Off-maintenance therapy for \> 36 months
* Age 10-30 years
* Reside within a 50 mile radius of the University of Minnesota

Exclusion Criteria:

* Pregnant or planning to become pregnant
* Start of oral contraceptives \< or = 3 months prior to study enrollment
* Current smoker
* Diabetes (type 1 and 2)
* Antibiotic use \< 2 weeks prior to study enrollment
A Clinical Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes

The purpose of this study is to assess the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) in the range 22-45
* Blood glucose criteria must be met
* Not currently on drug therapy for type 2 diabetes

Exclusion Criteria:

* Type 1 diabetes
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply
Real-World Study to Assess Subcutaneous Epcoritamab in Adult Participants With Diffuse Large B-Cell and Follicular Lymphoma

Diffuse large B-cell lymphoma (DLBCL) is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections) and the most common type of non-Hodgkin lymphoma. Follicular Lymphoma (FL) is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the real-world effectiveness of subcutaneous epcoritamab in adult participants with advanced DLBCL and FL.

Epcoritamab is an investigational drug being developed for treating participants with DLBCL and FL. Approximately 700 participants will be enrolled in approximately 80 sites across 12-20 countries globally.

Participants will receive epcoritamab as prescribed by their physician in accordance with local country label. Participants will be followed for up to 3 years.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are scheduled to be treated with epcoritamab for Treatment after two or more prior lines of therapy 3L+ diffuse large B-cell lymphoma ((D)LBCL) or 3L+ Follicular lymphoma (FL).
* Treatment with epcoritamab should be administered in accordance with the approved local label in the participating country.
* The decision to treat the participant should have been made by the clinician prior to, and independently of any decision to approach the participant to participate in this study.

Exclusion Criteria:

* Any condition included in the contraindications section of the approved local epcoritamab label in the participating country.
* Participation in a concurrent interventional clinical trial (not including non-interventional/ observational study, PMOS, or registry participation) from enrollment and throughout the study.
Perfusion Scanning's for Kidney Tumors

To investigate the ability of perfusion CT/US-scanning to facilitate recognition of different tumour sub-types in small renal masses less than 7 cm by non-invasive imagining technology.

The number of diagnoses of renal cell carcinoma has increased over the past two decades because of the incidental detection of small renal tumours resulting from increased use of computed tomography \[1,2\]. There are distinct subtypes of renal cell carcinoma (RCC), and the biological aggressiveness and prognoses for these subtypes have been documented. Clear-cell RCC is the most common RCC subtype, followed by papillary RCC, chromophobe RCC and unclassified RCC. Collecting duct carcinoma is a rare and highly malignant type of RCC. Although most enhancing renal masses in adults are RCC, a significant percentage are benign (commonly oncocytoma), and these benign tumours cannot be distinguished from malignant tumours based on our standard imaging technology alone.

Benign primary renal masses include simple renal cysts, psuedotumours, angiomyolipomas, oncocytomas, juxtaglomerular tumours, multilocular cystic nephromas, mesoblastic nephromas and papillary adenomas. In a recent surgical series of 228 patients who underwent partial or radical nephrectomy with lesions ≤4 cm, 26.3% were benign \[3\]. The relatively high percentage of patients with benign renal cortical neoplasms who undergo surgery highlights the importance of new diagnostic technology in avoiding over-treatment.

Ultrasound (US) and CT scanning guided biopsy is the most commonly used method to diagnosis RCC. The sensitivity of biopsy for small masses (≤3 cm) is lower than for large masses \[4\]. Sensitivity is limited by false-negative results, which are due to a failure to properly target a small mass or the presence of impossible-to-differentiate benign from malignant cells due to insufficient cells, morphological overlap or cellular heterogeneity. Non diagnostic biopsy is not necessary benign, as repeated biopsy reveals malignancy diagnosis in the majority\[5\]. There is no radiologic criteria consistent with oncocytoma because of a lack of sensitivity and specificity \[6\]. MR-scanning and CT-scanning are not feasible diagnostic methodologies for oncocytoma because of the possibility of overlapping results from oncocytoma and RCC \[7\].

Hypotheses: To investigate the ability of perfusion CT/US-scanning to facilitate recognition of different tumour sub-types in small renal masses less than 7 cm by non-invasive imagining technology.

Purpose: To recognize different subtype's renal tumor by non invasive scanning. Design: A descriptive study

Eligibility Criteria:
Inclusion Criteria:

1. Patients suspecting to have renal tumors by CT/UL-scanning.
2. Patients age between 35 and 75 years
3. Normal renal function
4. Can read and understand Danish
5. Non - metastasis disease detected by scanning

Exclusion Criteria:

1. Patients have a nephropathy (defined as e-GFR less than 50 ml/min/1.73cm³).
2. Previous allergic reaction to intravenous contrast material.
3. Untreated hyperthyroidism.
4. Pregnancy.