louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01486550: Hydroxyethyl Starch and Renal Function After Laparoscopic Nephrectomy
Official title: Effect of Hydroxyethyl Starch on Renal Handling of Salt and Water, Blood Pressure-regulating Hormones, Proteins and Circulatory System of Patients Undergoing Kidney Removal by Keyhole Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Cancer
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential nephrotoxic and examine the effects on the circulation and kidneys during administration of HES during surgery.

Detailed description: Hydroxyethyl starch (HES) is widely used in hospitals to maintain circulation in critically ill patients. In recent years studies have raised suspicion that HES is nephrotoxic. So far acute kidney injury has been diagnosed based on creatinine measurements, but new technology allows for earlier diagnosis using measurements of biomarkers in urine. The purpose of this project is to investigate HES's potential toxicity and effects on the circulation and kidneys using measurements of biomarkers specific for toxicity and for the sodium/water balance in the urine and by measurements of vasoactive hormones in the blood after administration of HES 130/0.4

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Males and females
* Indication for laparoscopic nephrectomy

Exclusion Criteria:

* Blood donation within the last month
* Lack of wish to participate
* eGFR\< 15ml/min
* Pregnancy or breast feeding

Primary outcomes:
measure: u-NGAL
timeFrame: 2-4 hours
Secondary outcomes:
measure: u-Kim1 and u-LFABP
timeFrame: 2-4 hours
measure: FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC
timeFrame: 2-4 hours
measure: PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endothelin
timeFrame: 2-4 hours
measure: SBP, DBP, heartrate
timeFrame: 2-4 hours
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Medicinck forskningsafsnit, Regionshospitalet Holstebro
Study officials:
affiliation: Regional Hospital Holstebro
name: Anne Sophie P. Kancir, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01205750: Hepatic Insulin Sensitivity and Very Low Density Lipoprotein Triglyceride (VLDL-TG) Kinetics
Official title: Basal and Insulin Mediated VLDL-triglyceride Kinetics in Obesity; Relationship With Hepatic Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Dyslipidemia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2010-09-20
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Obesity is associated with dyslipidemia, which is a major risk factor for coronary heart disease. Triglycerides (TG) and cholesterol are transported in the system of lipoproteins, and the metabolism of these lipids in plasma is closely interrelated. Evidence suggests that increased concentration of very low-density lipoprotein triglyceride (VLDL-TG) is a central pathophysiological feature of the lipid and lipoprotein abnormalities in dyslipidemia.

The primary objective of this study is to investigate VLDL-TG kinetics and hepatic insulin sensitivity in age-matched obese and lean, healthy men in the postabsorptive state and during acute hyperinsulinemia using VLDL-TG and glucose tracers.

Detailed description: Extensive description not included.

Eligibility criteria: Inclusion Criteria:

* Healthy
* BMI \< 25 kg/m2 or \> 30 kg/m2
* Informed consent

Exclusion Criteria:

* Alcohol misuse
* Smoking
* Use of prescription drugs

Primary outcomes:
measure: VLDL-TG kinetics
timeFrame: VLDL-TG kinetics are determined postabsorptively (250 minues) and during acute hyperinsulinemia (450 minutes)
Secondary outcomes:
measure: Hepatic insulin sensitivity
timeFrame: Glucose kinetics are determined postabsorptively (250 minues) and during acute hyperinsulinemia (450 minutes)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Study officials:
affiliation: Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Denmark
name: Søren Nielsen, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05411250: Early Diagnosis of Therapy-associated Cardiotoxicity Basing on PET/CT in Lymphoma
Official title: Early Diagnosis of Therapy-associated Cardiotoxicity Basing on PET/CT in Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Positron-Emission Tomography
Keywords: cardiotoxicity
early
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with malignant tumor after chemotherapy or immunotherapy

Brief summary: To explore the value of 18F-fluorodeoxyglucose (FDG) PET/CT imaging in early diagnosis of treatment-related cardiotoxicity (TACT) of lymphoma using visual method and semi-quantitative method.

Detailed description: First of all, the cardiac 18F-FDG uptake in patients with lymphoma will be observed by visual method: according to the uptake site, it will be divided into left ventricular uptake and biventricular uptake, and according to the degree of uptake, it will be divided into equal uptake (myocardial uptake is lower than cardiac blood pool uptake), moderate uptake (myocardial uptake is between cardiac blood pool uptake and liver uptake) and high uptake (myocardial uptake is higher than liver uptake). According to the uptake pattern, it can be divided into diffuse and segmental uptake.Then,using the region of interest method to mesure the value of myocardial uptake of 18F-FDG.The difference value of heart's SUVmax (Δ SUVmax- heart) and% Δ SUVmax- heart before and after chemotherapy or immunotherapy will be calculated. And SUVmax- heart / SUVmax- mediastinum ratio, SUVmax- heart / SUVmax- liver ratio and SUVmax- heart / SUVmax- background ratio (left gluteal muscle) after treatment. Taking the abnormality of ECG (early TACT) as the end point.

Eligibility criteria: Inclusion Criteria:

1. No previous history of heart disease.
2. normal echocardiography, ECG and laboratory tests (creatine kinase, myoglobin, troponin, brain natriuretic peptide) before treatment.

3.18F-FDG PET/CT examination before and after treatment

-

Exclusion Criteria:

1.receiving radiotherapy and chemotherapy at the same time. 2.previous chest radiotherapy. 3. with severe hepatic or renal dysfunction.

-

Primary outcomes:
measure: SUVmax
timeFrame: 150 days
Secondary outcomes:
measure: SUVR
timeFrame: 150 days
Other outcomes:
Locations:
Study officials:
affiliation: Peking cancer hospital
name: Zhi Yang, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05927350: Research Participation With Transgender and Gender-Diverse Youth
Official title: Research Participation With Transgender and Gender-Diverse Youth
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transgender Persons
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 250
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Transgender and gender-diverse adolescents

Brief summary: Research has historically excluded the participation of transgender and gender-diverse people. The purpose of this research study is to find out about what goes into a transgender and gender-diverse youth's decision to participate in research. The results of this study will be used to improve access to research for transgender and gender-diverse youth and therefore, improve the representation of transgender and gender-diverse youth as research participants in research.


Eligibility criteria: Inclusion Criteria:

* Gender identity different then sex assigned at birth
* Between the ages 15-21 years

Exclusion Criteria:

* Gender identity the same as their sex assigned at birth
* Younger than 15 years of age, and older than 21 years of age

Primary outcomes:
measure: Quantitative Assessment of Pediatric Research Participation in Transgender Youth
timeFrame: through study completion, estimated to be 3 months
measure: Qualitative Assessment of Pediatric Research Participation in Transgender Youth
timeFrame: through study completion, estimated to be 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: An Pham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03664050: Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary
Official title: Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Induction of Ovulation
Keywords: letrozol
laparoscopic ovarian drilling
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this work is to compare the clinical outcomes of letrozole with laparoscopic ovarian drilling (LOD) in patients with clomiphene-citrate-resistant polycystic ovary syndrome (PCOS).


Eligibility criteria: Inclusion Criteria:

1. patients diagnosed as PCOS according to Roterdam (2003) criteria
2. patients with Clomiphene resistance, i.e. failure to ovulate following 100 mg CC for 5 days for at least three cycles.
3. patent fallopian tubes, confirmed by hysterosalpingography or hysteroscopic diagnosis.
4. normal semen analysis parameters of the patients' spouses according to the modified criteria of the World Health Organization.
5. normal serum prolactin, thyroid stimulating hormone and 17-OH progesterone.
6. no systemic disease; no gonadotropin or other hormonal drug treatment during the preceding 3 months.

Exclusion Criteria:

1- Infertility induced by reasons other than PCOS. 2- uterine cavity lesions or ovarian cyst. 3- \>40 years old. 4- body mass index (BMI) \>26 kg/m2. 5- contraindications to general anesthesia. 6- history of pelvic surgery. 7- other endocrine diseases. 8- a history of liver or kidney disease.

-

Primary outcomes:
measure: OVULATION RATE
timeFrame: 7 DAYS BEFORE NEXT MENSES
Secondary outcomes:
measure: BIOCHEMICAL PREGNANCY RATE
timeFrame: AFTER 30 DAYS OF INTERVENTION
measure: CLINICAL PREGNANCY RATE
timeFrame: AT 6 WEEKS GESTATION
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university maternity hospital
Study officials:
References:
citation: Franik S, Le QK, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for ovulation induction in infertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2022 Sep 27;9(9):CD010287. doi: 10.1002/14651858.CD010287.pub4.
Clinical trial NCT00250250: An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG
Official title: An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG (Recombinant Somatropin) Administered by ZomaJet Vision X
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Turner's Syndrome
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-11-08
Enrollment: 27
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Children with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome are individually dosed and treated for 12 weeks

Detailed description: Ferring Pharmaceuticals A/S has developed a new ZOMACTON 10 mg formulation. The formulation provides a higher concentration and thereby a smaller volume to be administered. ZomaJet Vision X is a needle-free injection system. It sends a thin jet of ZOMACTON through the skin and into the subcutaneous tissue without the use of a needle. The mode of administration is referred to as "transjection". By use of ZomaJet Vision X, both transjection and reconstitution of ZOMACTON 10 mg can be done without using a needle. The rationale of the study is to describe the local tolerability of the new ZOMACTON 10 mg administered by ZomaJet Vision X.

Eligibility criteria: Subjects between the ages of 3 and 17 years (both inclusive) with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome. Subjects have for a minimum of 6 months prior to study enrolment been receiving growth hormone therapy

Primary outcomes:
measure: To assess the local tolerability of an individualised dose of ZOMACTON 10 mg administered by ZomaJet Vision X
Secondary outcomes:
Other outcomes:
Locations:
city: Olomouc
country: Czech Republic
facility: Faculty Hospital Olomouc, Children's Clinic, Endocrinology Outpatient Department, I.P.Pavlova str. 6,
city: Prague 10
country: Czech Republic
facility: Faculty Hospital Kralovske Vinohrady, Children's Clinic, Vinohradska str. 159
city: Usti nad Labem
country: Czech Republic
facility: Masaryk Hospital Usti nad Labem, Children's Clinic, Building D2, Endocrinology Outpatient Department, Socialni pece 12a
city: Bordeaux
country: France
facility: Centre d'Endocrinologie Pediatrique, 25 rue Boudet
city: Le Havre cedex
country: France
facility: Service de Pédiatrie, Groupe Hospitalier du Havre, 55 bis, rue Gustave Flaubert
city: Amsterdam
country: Netherlands
facility: Vu medisch centrum, Paediatrics, De Boelelaan 1117, PO Box 7057
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT01886950: Evolution of Bone Histomorphometry and Vascular Calcification Before and After Renal Transplantation
Official title: A Prospective Observational Study to Investigate the Natural History of Bone Histomorphometry and Vascular Calcification in Dialysis-dependent Patients Before and After Renal Transplantation.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease
Keywords: CKD stage 5
Bone histomorphometry
Renal transplantation
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: end stage renal disease patients able to consent

Brief summary: A study of the natural history of bone and mineral disease (BMD) in patients with end-stage renal disease before and after kidney transplantation

Detailed description: Disturbances of mineral and bone diseaeses are frequently observed in CKD patients. Renal osteodystrophy is the term to describe the bone abnormalities. Epidemiological data showed adynamic bone disease (ABD) is the most frequent bone disorder in CKD stage 5D diseases. Low PTH, diabetes mellitus, malnutrition, metabolic acidosis, hypogonadism and low 1,25(OH)2D vitamin D deficiency are known risk factors for ABD. Mounting experimental data point towards a role of protein-bound uremic retention molecules (p-cresyl sulfate and indoxyl sulfate) in the pathogenesis and progression of ABD. ABD is not only recognized as a risk factor for fractures but also for arterial calcification.

The aim of the present study is (1) to investigate the role of indoxyl sulfate and p-cresyl sulfate in the pathogenesis and progression of ABD and arterial calcification in CKD stage5 and (2) to investigate the influence of renal transplantation on bone and arterial metabolism.

Eligibility criteria: Inclusion Criteria:

* eligible for renal transplantation and \>18 years

Exclusion Criteria:

* use of biphosphonates within the 6 months before the study entry

Primary outcomes:
measure: bone turnover, as assessed by bone biopsy
timeFrame: at the start of the study
measure: Evolution of bone turnover, as assessed by bone biopsy
timeFrame: after 1 year
measure: aortic calcification, as assessed by lumbar X-ray
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Pieter Evenepoel, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jorgensen HS, Behets G, Bammens B, Claes K, Meijers B, Naesens M, Sprangers B, Kuypers DRJ, Cavalier E, D'Haese P, Evenepoel P. Natural History of Bone Disease following Kidney Transplantation. J Am Soc Nephrol. 2022 Mar;33(3):638-652. doi: 10.1681/ASN.2021081081. Epub 2022 Jan 19.
Clinical trial NCT02928250: Role of Carnosine as an Adjuvant Therapy for Diabetic Nephropathy in Pediatrics With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Oxidative Stress
Carnosine
Diabetic Nephropathy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 90
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carnosine, a naturally-occurring dipeptide (β-alanyl-L-histidine) first described in 1900 by Gulewitsch and Amiradzibi, is found predominantly in post-mitotic tissues (e.g. brain and innervated muscle) of vertebrates . Carnosine is claimed to decrease oxygen free-radical mediated damage to cellular macromolecules either by chelating divalent cations or scavenging hydroxy radicals with its imidazole moiety. Free-radical damage is not the only process to affect the structure of proteins and nucleic acids.

To the best of our knowledge, no previous study assessed the role of carnosine in diabetes associated complications in particular diabetic nephropathy and there is insufficient evidence to recommend its supplementation in those patients. Therefore, this study was undertaken to investigate the role of carnosine as an adjuvant therapy for diabetic nephropathy in children and adolescents with type 1 diabetes and assess its relation to microalbuminuria, tubulointerstitial damage marker, glycemic control and oxidative stress.


Eligibility criteria: Inclusion Criteria:

* patients with type 1 diabetes.
* have diabetic nephropathy (≤18 years with at least 5 years disease duration )

Exclusion Criteria:

* any clinical evidence of infection, renal impairment due to causes other than diabetes, elevated liver enzymes, hypertension, neoplasm, hypersensitivity to carnosine, and taking any vitamins or food supplements one month before study or participation in a previous investigational drug study within the 30 days preceding screening.

Primary outcomes:
measure: effect on on urinary albumin excretion (UAE)
timeFrame: three months
Secondary outcomes:
measure: effect on alpha 1 microglobulin(A1M))
timeFrame: three months
measure: total antioxidant capacity (TAC), malondialdhyde (MDA).
timeFrame: three months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05365750: COVID-19 Antibody and Reinfection Study
Official title: COVID-19 Antibody and Reinfection Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19 Testing
Keywords: SARS-CoV-2
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 4235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study cohort will include individuals who are enrolled in KPCO's health plan.

Individuals will be selected who have evidence of prior SARS CoV-2 infection and random samples of the general KPCO membership of similar demographic characteristics who appear not to have had SARS CoV-2 infection.

Brief summary: The goal of this study is to establish a cohort of Kaiser Permanente Colorado (KPCO) members who have and have not had COVID-19 infection for serial antibody testing and PCR testing to:

1. Quantify antibody titers among participants over 9 months.
2. Determine the rates of asymptomatic, mild, and severe recurrent infection among participants with prior COVID-19.
3. Examine association between antibody titer levels and risk of recurrent infection using a case control analysis nested in the cohort.

Detailed description: In this study, the Kaiser Permanente Colorado (KPCO) Institute for Health Research (IHR) will evaluate SARS-CoV-2 IgG antibody titers over time among individuals with evidence of prior infection, and correlate antibody titers with risk of recurrent infection. The investigators will identify KPCO members who have and have not had prior infection, enroll them into a cohort study, conduct serial surveys for new COVID-19 symptoms, and facilitate serial viral and antibody testing.

All laboratory testing procedures and clinical management of participants will be conducted by KPCO operations. The research team will identify participants, obtain consent, administer surveys to assess COVID-19 symptoms, and direct patients to the appropriate testing. Health outcomes on cohort participants will be tracked with survey data on symptoms, clinical and utilization data from the KPCO electronic health record (e.g., hospitalization), and laboratory data (e.g., viral test results).

This research-operations partnership strategy will generate data to better understand the implications of positive antibody titers to this novel pathogen.

Eligibility criteria: Inclusion criteria are:

* KPCO health plan members,
* 18 years and older,
* Have a valid email address or phone number in the electronic health record.

Exclusion criterion:

• Being on the Do Not Call List for research.

Primary outcomes:
measure: Antibody result
timeFrame: April 2020 - January 2022
Secondary outcomes:
measure: Reinfections
timeFrame: April 2020 - January 2022
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Kaiser Permanente
state: Colorado
Study officials:
affiliation: Kaiser Permanente
name: Ingrid Binswanger, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References: