louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02702765: sCD163 and sMR in Wilsons Disease - Associations With Disease Severity and Fibrosis
Official title: Macrophages and the Macrophage Activation Markers sCD163 and Mannose Receptor (sMR) in Patients With Wilsons Disease - Associations With Liver Disease Severity and Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wilsons Disease
Keywords: sCD163
liver cirrhosis
disease severity
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2016-03-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim is to investigate macrophage activation markers and correlations to liver fibrosis in patients with Wilsons Disease. Researchers wish to investigate associations to neurologic and metabolic liver function. Researchers will assess this by comparing blood samples with fibrosis and liver function analyses. This study provides new insight into macrophages and their involvement in Wilsons Disease.


Eligibility criteria: Inclusion Criteria:

* diagnosed with Wilsons disease

Exclusion Criteria:

-

Primary outcomes:
measure: Measurement of the macrophage activation markers sCD163
timeFrame: Baseline, 1 year, 2 year, 3 year
measure: Measurement of soluble mannose receptor (sMR)
timeFrame: Baseline, 1 year, 2 year, 3 year
Secondary outcomes:
measure: Urinary copper excretion in 24 hour urine collection
timeFrame: Baseline, 1 year, 2 year, 3 year
measure: Ultrasound is performed for signs of liver cirrhosis.
timeFrame: Baseline, 1 year, 2 year, 3 year
measure: Fibroscan is performed to evaluate liver stiffness (fibrosis)
timeFrame: Baseline, 1 year, 2 year, 3 year
measure: Continous Reaction Time to evaluate brain dysfunction
timeFrame: Baseline, 1 year, 2 year, 3 year
measure: Galactose elimination capacity is performed to evaluate metabolic liver function
timeFrame: Baseline, 1 year, 2 year, 3 year
measure: Histological disease activity at time of diagnosis and liver biopsy, evaluating if any liver fibrosis
timeFrame: Baseline, 1 year, 2 year, 3 year
measure: Functional hepatic nitrogen clearance to evaluate metabolic liver function
timeFrame: Baseline, 1 year, 2 year, 3 year
measure: The Portosystemic Encephalopathy to evaluate brain dysfunction
timeFrame: Baseline, 1 year, 2 year, 3 year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Hepatology and Gastroenterology, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital, Nørrebrogade 44, Aarhus C, Denmark, 8000
name: Henning Grønbæk, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjorklund J, Laursen TL, Sandahl TD, Moller HJ, Vilstrup H, Ott P, Gronbaek H. High hepatic macrophage activation and low liver function in stable Wilson patients - a Danish cross-sectional study. Orphanet J Rare Dis. 2018 Sep 21;13(1):169. doi: 10.1186/s13023-018-0910-7.
Clinical trial NCT01279265: Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic
Official title: Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Crying, Intestinal Microbiota, and Intestinal Inflammation in Infants With Colic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colic
Inflammation
Keywords: Lactobacillus
Probiotic
Crying time
Fecal microbiota
Calprotectin
Colic
Infant Crying
Barr Diary
Breath Hydrogen
Clinical Design
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Mead Johnson Nutrition
First posted: 2011-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will compare 2 currently marketed formulas in healthy full term babies: Nutramigen A+ (a hypoallergenic formula) and Nutramigen-Enflora (hypoallergenic formula with Lactobacillus GG (LGG)) during 3 months of formula feeding. The investigators' aims are to compare 3 outcomes in these babies: (1) normal baby crying time; (2) the composition of intestinal microbiota (bacteria in the stool); and (3) a lab test which measures the number of white blood cells in the large intestine (fecal calprotectin). The investigators predict that LGG supplementation (Nutramigen-Enflora) will facilitate its establishment as an important component of the neonatal intestinal microbial community and reduce fecal calprotectin.


Eligibility criteria: Inclusion Criteria:

* Sixty healthy full-term colicky infants (gestational age 32 wks to 41 wks)

Exclusion Criteria:

* chronic lung disease,
* diarrhea (stools that take the shape of a container \> 5x daily)
* fever

Primary outcomes:
measure: Daily Average Crying and Fussing Duration According to Barr Diary Records
timeFrame: 90 days
Secondary outcomes:
measure: Fecal Microbiota
timeFrame: 90 days
measure: Fecal Calprotectin
timeFrame: 90 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: J. M Rhoads, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rhoads JM, Fatheree NY, Norori J, Liu Y, Lucke JF, Tyson JE, Ferris MJ. Altered fecal microflora and increased fecal calprotectin in infants with colic. J Pediatr. 2009 Dec;155(6):823-828.e1. doi: 10.1016/j.jpeds.2009.05.012. Epub 2009 Jul 22.
citation: Rhoads JM, Collins J, Fatheree NY, Hashmi SS, Taylor CM, Luo M, Hoang TK, Gleason WA, Van Arsdall MR, Navarro F, Liu Y. Infant Colic Represents Gut Inflammation and Dysbiosis. J Pediatr. 2018 Dec;203:55-61.e3. doi: 10.1016/j.jpeds.2018.07.042. Epub 2018 Aug 31.
Clinical trial NCT03799965: The Effect of Advanced Improvement Program (ERAS) on Postoperative Outcomes in Patients Undergoing Open Heart Surgery
Official title: Investigation of the Effect of Enhanced Recovery After Surgery (ERAS) Program on Postoperative Results of Patients Operated for Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enhanced Recovery After Surgery
Open Heart Surgery
Lead sponsor: Kocaeli Derince Education and Research Hospital
Sponsor class: OTHER
Collaborators: name: Kocaeli University
First posted: 2019-01-10
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Investigation of the effect of Enhanced Recovery After Surgery (ERAS) program on postoperative results of patients operated for open heart surgery.

Detailed description: The ERAS protocol, also known as evidence based "fast-track surgery" (FTS), is an evidence based combination of findings regarding suggestions for patient care on various levels of the perioperative period, which work in synergy for accelerating the postoperative recovery period. It has been used sucessfully for many surgical disciplines, primarily colorectal surgery, since it was first reported in 1997. However, there is a significant insufficiency of this patient oriented rehabilitation program regarding cardiovascular surgeries. This study is to compare the postoperative follow up periods of patients with ERAS protocol and patients with standard protocol who were both operated for cardiac surgery.

Following approval of the local ethics committee, 210 patients who are operated for elective cardiac surgery are enrolled in this prospective randomized clinical trial. The patients who are not applied the ERAS protocol are evaluated in the control group (n=51). The findings regarding the patients under ERAS protocol are evaluated based on evidence. Our primary is to compare the durations of stay in the intensive care unit and in hospital; our secondary is to compare the incidences of complications of the groups. The demographic data, operative measurements, complication rates, the amounts of perioperative bleeding and drainage and the duration of stay in the intensive care unit and hospital are recorded.

Eligibility criteria: Inclusion Criteria:

* over 18 years old;
* Patients undergoing elective open heart surgery (cardiopulmonarybiasis, aortic and mitral valve replacement);
* ASA III ;
* Patients with informed consent for the study.

Exclusion Criteria:

* Patients who refuse to participate in the study;
* Patients under emergency conditions.

Primary outcomes:
measure: durations of stay
timeFrame: 24 hours
measure: complications
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Emine yurt
state: Derince
Study officials:
References:
Clinical trial NCT01921465: Outpatient Care for Multiparas After Elective Cesarean Section: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Outpatient Care
Keywords: outpatient care
videoconferencing
elective cesarean section
Lead sponsor: Herning Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2013-08-13
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: multiparas having a elective cesarean section at Herning hospital

Brief summary: The purpose of the study is to evaluate whether outpatient cesarean section can be performed in multiparous women without significant decrease in the parents' sense of security .


Eligibility criteria: Inclusion Criteria:

* Planned elective cesarean section of multiparous women
* Singleton pregnancy
* Age of at least 18
* Gestational age between 37 and 42 weeks
* Internet access at home

Exclusion Criteria:

* Lack of consent
* Women with no or little understanding of Danish and ability to speak Danish.
* Allergies to medicine included in the pain management regimes
* Expected maternal or neonatal complications after delivery
* Birth weight of less than 2500 grams

Primary outcomes:
measure: the parents' postnatal sense of security (PPSS)
timeFrame: the PPSS is measured the second week after delivery
Secondary outcomes:
measure: ambulation time
timeFrame: three days
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Department of gynaecology and obstetrics, Herning Hospital
Study officials:
affiliation: University of Aarhus
name: Iben P Lorentzen, Midwife
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00518765: Hemodynamic Effects of Aliskiren Compared to Captopril on the Kidney in Healthy Volunteers on a Low- and High- Sodium Diet
Official title: A Single-center, Placebo-controlled Study of the Effects of Ascending Single Oral Doses of Aliskiren Compared With Captopril on Renal Hemodynamics in Healthy Volunteers on a Low and High Sodium Diet "Renin Inhibition and the Kidney"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: aliskiren, renal hemodynamics, hormonal response, renin pathway, RAAS biomarkers
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-08-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will measure the effects of different doses of aliskiren on kidney blood flow and function in healthy adults and determine how salt intake affects the response to aliskiren.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects age 18 to 75 years of age included
* Strictly adhere to provided diet.

Exclusion Criteria:

* Symptomatic low blood pressure
* Prescription medications, including those for blood pressure control, birth control pills, and any other medication that could affect kidney function
* Over-the-counter medication 2 weeks before study start
* Clinically significant heart abnormalities.
* Previous history of allergy to the study drug or drugs similar to the study drug.
* Any surgical or medical condition which might significantly alter the action of a drug (for example, absorption, distribution, metabolism or excretion) or which may jeopardize the subject in case of participation in the study.

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Renal plasma flow following 3 single doses of aliskiren in healthy volunteers on a low sodium(10 mEq/day)diet
timeFrame: baseline and hourly intervals.
Secondary outcomes:
measure: Single dose application of aliskiren on renal hemodynamics and circulating markers of the renin pathway
timeFrame: baseline, and at 5 hours, and 24 hours post dose
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Investigative site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fisher ND, Jan Danser AH, Nussberger J, Dole WP, Hollenberg NK. Renal and hormonal responses to direct renin inhibition with aliskiren in healthy humans. Circulation. 2008 Jun 24;117(25):3199-205. doi: 10.1161/CIRCULATIONAHA.108.767202. Epub 2008 Jun 16.
Clinical trial NCT05834465: High Intraocular Pressure After Cataract Surgery
Official title: Efficacy Evaluation of Anterior Chamber Drainage in Patients for High Intraocular Pressure After Cataract Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Intraocular Pressure
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Included in Eye Hospital of Wenzhou Medical University for "phacoemulsification combined with intraocular lens implantation" 2 hours after using a non-contact tonometer (FT-1000, TOMEY, JAPAN) to check that the intraocular pressure exceeds 28mmHg accompanied by corneal edema, anterior chamber radiation and age-related cataract patients over 60 years of age is required.

Brief summary: Effectiveness of anterior chamber drainage on the structure of the anterior chamber, the position of the intraocular lens and the shape of the corneal incision in the early stage of cataract surgery with high intraocular pressure

Detailed description: To explore the effect of different degrees of anterior chamber drainage on the structure of the anterior chamber, the position of the intraocular lens and the shape of the corneal incision in the early stage of cataract surgery with high intraocular pressure

Eligibility criteria: Inclusion Criteria:

1. Patients over 60 years old who underwent simple age-related cataract surgery in Eye Hospital of Wenzhou Medical University, the operation was successful, and there were no intraoperative complications such as posterior capsule rupture;
2. Measurements were taken before and after drainage, and all data were complete ;
3. The patient agrees and accepts the study.

Exclusion Criteria:

1. Preoperative glaucoma, ocular hypertension, iritis, uveitis and other eye diseases, as well as other eye diseases and serious systemic diseases that may affect the prognosis of surgery, such as corneal lesions, vitreous volume blood, retinal detachment, poor blood sugar control in diabetes, etc.
2. Previous history of eye trauma, etc.
3. Cannot cooperate with the completion of intraocular pressure measurement and CASIA2 examination.

Primary outcomes:
measure: The position of IOL through tilt (tilt in degree)
timeFrame: Two hours after cataract surgery (i.e. before anterior chamber drainage)
measure: The position of IOL through decentration (decentration in millimeter)
timeFrame: Two hours after cataract surgery (i.e. before anterior chamber drainage)
measure: The position of IOL through tilt (tilt in degree)
timeFrame: Immediately after anterior chamber drainage
measure: The position of IOL through decentration (decentration in millimeter)
timeFrame: Immediately after anterior chamber drainage
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
References:
Clinical trial NCT04086420: Mindfulness-Based Physical Activity Intervention
Official title: A Mindfulness-Based Physical Activity Intervention: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Mindfulness
Physical Activity
Lead sponsor: Southern Methodist University
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of this parallel two-arm pilot randomized controlled trial is to assess the feasibility and acceptability of an audio-recorded mindfulness-based intervention and to assess whether the intervention results in a clinically meaningful difference in physical activity compared to the control condition


Eligibility criteria: Inclusion Criteria:

* Reported less than 60-minutes of weekly moderate-to-vigorous physical activity (MVPA, moderate physical activity minutes + vigorous physical activity minutes\*2)
* Safe to exercise at moderate intensity without a doctor's approval according to American College of Sports Medicine Criteria
* Had a smart phone to access the audio-recorded mindfulness-based physical activity intervention

Primary outcomes:
measure: Physical Activity Minutes
timeFrame: 1-Week Follow-Up
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Southern Methodist University
state: Texas
Study officials:
References:
citation: Sala M, Geary B, Baldwin AS. A Mindfulness-Based Physical Activity Intervention: A Randomized Pilot Study. Psychosom Med. 2021 Jul-Aug 01;83(6):615-623. doi: 10.1097/PSY.0000000000000885.
Clinical trial NCT06643520: 19G FNB Needle Vs 22G FNB Needle for EUS-Guided Liver Biopsy
Official title: Sample Adequacy and Diagnostic Accuracy of a 22 Gauge FNB Needle Vs a 19G FNB Needle for EUS-guided Liver Biopsy: a Prospective Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Endoscopic Ultrasonography
Liver Biopsy
Lead sponsor: Duzce University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: EUS-guided liver biopsy (EUS-LB) is increasingly used to diagnose patients with liver disease, especially in anxious patients who need sedation. There is an ongoing debate about the optimal needle size for EUS-LB. Some clinicians prefer a thinner 22-gauge biopsy needle because they presume it to be safer, and some studies show that their performance is the same as a thicker 19-gauge needle. However, some other studies show that the adequacy and diagnostic accuracy of a 19-gauge needle is better, and the rates of adverse events are the same. In this study, we aimed to compare the adequacy and diagnostic accuracy of samples obtained by the same endoscopist from the same liver lobe during the same session.


Eligibility criteria: Inclusion Criteria:

* All patients with unexplained elevation of liver enzymes and suspected hepatic paranchymal disease

Exclusion Criteria:

* Patients who had malignancy
* Patients who have decompensated cirrhosis
* Presence of ascites
* Patients with coagulopathy (platelets \< 50.000 μ/ mL and INR \> 1.5)
* The use of anticoagulant agents
* Pregnancy
* Unable to provide written informed consent

Primary outcomes:
measure: Sample adequacy
timeFrame: 1 month
Secondary outcomes:
measure: Adverse events
timeFrame: 1 week
Other outcomes:
Locations:
city: Duzce
country: Turkey
facility: Duzce University
Study officials:
References:
citation: Shah RM, Schmidt J, John E, Rastegari S, Acharya P, Kedia P. Superior Specimen and Diagnostic Accuracy with Endoscopic Ultrasound-Guided Liver Biopsies Using 19-Gauge versus 22-Gauge Core Needles. Clin Endosc. 2021 Sep;54(5):739-744. doi: 10.5946/ce.2020.212. Epub 2020 Nov 13.
citation: Dalal A, Kamat N, Patil G, Vadgaonkar A, Parekh S, Vora S, Maydeo A. Comparison of diagnostic outcomes, safety, and cost of Franseen-tip 19G versus 22G needles for endoscopic ultrasound-guided liver biopsies. Endosc Int Open. 2024 Feb 28;12(2):E291-E296. doi: 10.1055/a-2226-1337. eCollection 2024 Feb.
citation: Diehl DL, Sangwan V, Johal AS, Khara HS, Confer B. Comparing a 19-gauge fine-needle biopsy needle with a 22-gauge fine-needle biopsy needle for EUS-guided liver biopsy sampling: a prospective randomized study. Gastrointest Endosc. 2024 Jun;99(6):931-937. doi: 10.1016/j.gie.2023.12.022. Epub 2023 Dec 21.
Clinical trial NCT04642820: Drugs Brain and Behavior (DDP)
Official title: Drugs Brain and Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stimulant Use
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-11-24
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this project, we will examine individual differences in the effects of a stimulant drug, methamphetamine (MA), on mesolimbic reward function using fMRI.


Eligibility criteria: Inclusion Criteria:

* BMI between 19 and 26
* Right Handed
* Less than 4 alcohol or caffeinated beverages a day.

Exclusion Criteria:

* High blood pressure
* Any medical condition requiring regular medication
* Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
* Individuals with a history of dependence on stimulant drugs
* Women who are pregnant or trying to become pregnant.

Primary outcomes:
measure: Change in SUbjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ).
timeFrame: Time Frame: Day 1(baseline), 3
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: Principal Investigator
name: Harriet de Wit
role: PRINCIPAL_INVESTIGATOR
References: