louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00413348: Type 2 Diabetes and the Effect of Probiotics
Official title: Effect of Probiotics on Systemic Inflammation and Insulin Resistance in Type 2 Diabetics and Healthy Controls
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Healthy
Endotoxemia
Keywords: Type 2 diabetes
Probiotics
Insulin-resistance
Inflammation
Hyperinsulinemic euglycemic clamp
Endotoxin
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Royal Veterinary and Agricultural University, Denmark
First posted: 2006-12-19
Enrollment: 48
Sex: MALE
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Insulin-resistance in type 2 diabetes is associated with chronic inflammation. Anti-inflammatory actions might increase sensitivity to insulin. Since some probiotics have anti-inflammatory properties, ingestion of the probiotic bacteria Lactobacillus Acidophilus NCFM might increase insulin-sensitivity.

The inflammatory response to endotoxin injection and the insulin-sensitivity is examined before and after four weeks ingestion of probiotics.

Detailed description: Numerous studies have shown an association between insulin-resistance in type 2 diabetes and chronic low-grade inflammation. Some probiotics have an anti-inflammatory properties. Ingestion of probiotics might therefore, due to this property, increase sensitivity to insulin.

In this study type 2 diabetics (N=24) and healthy control (N=24) are given the probiotic bacteria Lactobacillus Acidophilus NCFM for four weeks. The anti-inflammatory effect is examined by evaluating the inflammatory response (White blood cell count, plasma-cytokines) to an iv injection of endotoxin (0,3 ng/kg) before and after the intervention. Also the insulin-sensitivity is measured with an hyperinsulinemic euglycemic clamp before and after L. acidophilus NCFM.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Type 2 diabetes

Exclusion Criteria:

* Heart failure
* Lung disease
* Infections in the last two weeks before endotoxin injections.
* Treatment with antibiotics

Primary outcomes:
measure: Change in insulin-resistance
measure: Change in inflammatory response to E. coli endotoxin injection
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center of Inflammation and metabolism 7641 and Intensive Care Unit 4131, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Anne Sofie Andreasen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00223548: MESNA for Prevention of Acute Deterioration of Renal Function Following Contrast Agent Application
Official title: MESNA Zur Prophylaxe Der Kontrastmittel-Induzierten Nephropathie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Renal Insufficiency
Serum Creatinine Concentration
Contrast Media Exposition
Keywords: prophylaxis
contrast-induced nephropathy
mesna
acute renal failure
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine wether Mesna could prevent contrast-induced nephropathy

Detailed description: Contrast-induced nephropathy remains a common complication of radiographic precedures. Pretreatment with Mesna (Sodium 2-mercaptoethane sulfonate) in combination with sodium chloride is more protective than sodium chloride alone in animal models of acute renal failure.

The aim of this study is therefore to determine laboratory and clinical benefit of MESNA, as an adjunct to saline hydration, in patients with known renal impairment receiving contrast media.

Eligibility criteria: Inclusion Criteria:

* stable chronic renal insufficiency
* serum creatinine concentration \> 1,5 mg/dl

Exclusion Criteria:

* Dialyzed patients
* patients with acute renal failure
* received iodinated contrast media within 7 days before study entry
* known allery to Mesna, pregnancy, and administration of dopamine, mannitol or N-acetylcysteine

Primary outcomes:
measure: Contrast-agent associated nephrotoxicity was defined as an increase in serum creatinine concentration >0.5 mg/dl (44 umol/l) of the baseline value 48 h after administration of the contrast media.
Secondary outcomes:
measure: Need for dialysis after the administration of contrast media.
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Division of Nephrology, University of Ulm
Study officials:
affiliation: Division of Nephrology, University Hospital Ulm
name: Frieder Keller, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Nephrology, University Hospital of Ulm
name: Frieder Keller, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06432348: Pilates Exercises and Soccer: A Comparative Study of Mat vs. Reformer on FMS and ROM
Official title: Pilates Exercises and Soccer: A Comparative Study of Mat vs. Reformer on FMS and ROM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports, Mechanical
Keywords: Functional movement screening
Mat pilates
Reformer pilates
Range of motion
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pilates exercises have been used to improve core strength, trunk and shoulder strength, lower body strength, agility, dynamic balance, coordination skills, flexibility, and posture in various sports. A previous study demonstrated the beneficial impact of mat Pilates exercises on the functional performance of soccer players. However, more research is needed to understand the effects of Pilates on the FMS and ROM. Consequently, this study aimed to investigate and compare the influence of mat Pilates and reformer Pilates exercises on FMS and ROM in soccer players, addressing this critical research gap.


Eligibility criteria: Inclusion Criteria:

* Age: Adults 19 to 20 years old
* Gender: Male
* Volunteering players

Exclusion Criteria:

- Diagnosis: Diagnosis of a specific medical condition

Primary outcomes:
measure: Functional Movement Screening and range of motion tests
timeFrame: One week
measure: Range of motion tests
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Osmaniye
country: Turkey
facility: Osmaniye Korkut Ata University
Study officials:
References:
Clinical trial NCT05888948: Surgical Emergencies Gradation and Postoperative Outcome
Official title: Effect of Implementation of a Surgical Emergencies Gradation on Postoperative Outcome in Emergency Operating Theatre Patients of the Amiens-Picardy University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emergency Surgery
Mortality
Keywords: emergency surgery
gradation
Complication
mortality
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring non-cardiac emergency surgery at the Amiens-Picardie University Hospital will be included. A posteriori grading will be performed according to an institutionally recognised gradation. Each grade is subject to a theoretical maximum time for surgical management. The surgical waiting time and the waiting time exceeding the theoretical expected time of the gradation will be analysed.

Brief summary: Reducing surgical waiting time has been shown to be associated with a reduction in postoperative morbidity and mortality in this type of surgery. The use of a gradation of surgical emergencies makes it possible to prioritise them in an objective, consensual manner and to carry them out within a theoretical expected waiting time relative to the degree of urgency. The investigators hypothesise that exceeding the theoretical expected waiting time relative to the degree of urgency defined by the gradation of surgical emergencies is associated with an increase in postoperative morbidity and mortality in emergency surgery. The objective is to assess the impact on post-operative morbidity and mortality of waiting times exceeding the theoretical expected time by grading the surgical emergencies of patients undergoing emergency surgery.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years old.
* Non-cardiac emergency surgery.

Exclusion Criteria:

* Minor patients
* Emergency cardiac surgery
* Patients under guardianship or curators
* Pregnant women
* Patients who object to their personal data being used in research

Primary outcomes:
measure: Number Post-operative complications
timeFrame: 1 year
measure: Mortality at 1 year
timeFrame: 1 year
measure: Length of stay in intensive care unit
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
References:
Clinical trial NCT01238848: Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis
Official title: A Randomized Controlled Trial to Evaluate Efficacy of Nebulized Hypertonic Saline vs. Normal Saline in the Treatment of Hospitalized Children With Bronchiolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: Hypertonic
Saline
Bronchiolitis
Efficacy
Lead sponsor: Hospital General de Niños Pedro de Elizalde
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 82
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital stay, oxygen requirements and clinical outcome.

Detailed description: Despite bronchiolitis is a very frequent disease among infants, there are still controversies regarding its treatment. Hypertonic saline has been proposed as useful treatment in these children, bur information is still controversial.

The aim is to asses that using Nebulized Hypertonic Saline with bronchodilators (albuterol) may reduce the days of hospitalization and improve clinical outcomes in patients with acute bronchiolitis, compared with using Normal Saline with albuterol.

Eligibility criteria: Inclusion criteria:

* Infants aged 1 to 24 months, hospitalized for first episode of bronchiolitis, with severity score ≥ 5 points and oxygen saturation ≥ 97%.

Exclusion Criteria:

* Chronic respiratory or cardiovascular disease, respiratory failure.

Primary outcomes:
measure: Hospitalization Days
timeFrame: Participants will be followed for the duration of hospitalization, an expected average of 4 days
Secondary outcomes:
measure: Length of Oxygen Use
timeFrame: Participants will be followed for the duration of hospitalization, an expected average of 4 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital General de Niños Pedro de Elizalde
state: CF
Study officials:
affiliation: Hospital General de Niños Pedro de Elizalde
name: Maria I Espelt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulized hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006458. doi: 10.1002/14651858.CD006458.pub2.
citation: Ralston S, Hill V, Martinez M. Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. Pediatrics. 2010 Sep;126(3):e520-5. doi: 10.1542/peds.2009-3105. Epub 2010 Aug 16.
Clinical trial NCT06600048: Spinal Anesthesia by Hyperbaric Prilocaine in Day-Case Perianal Surgery
Official title: Spinal Anesthesia by Hyperbaric Prilocaine in Day-Case Perianal Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anesthesia
Hyperbaric
Prilocaine
Day-Case
Perianal Surgery
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of spinal anesthesia by hyperbaric prilocaine in day-case perianal surgery.

Detailed description: Day-case spinal anesthesia with short-acting local anesthetics such as lidocaine and chloroprocaine can provide short times to discharge. However, the association of lidocaine with transient neurologic symptoms (TNS) and chloroprocaine with neurologic injury has limited the use of these agents in spinal anesthesia.

Hyperbaric bupivacaine has been used for spinal anesthesia for decades owing to the low incidence of TNS.

Prilocaine is also an amide local anesthetic that has an intermediate duration of action. It is available in the hyperbaric form that can be used for spinal anesthesia in day-case surgeries.

Hyperbaric prilocaine provides faster spinal block onset and earlier patient recovery in ambulatory surgery compared to plain prilocaine.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Scheduled for perianal surgery under spinal anesthesia.

Exclusion Criteria:

* Allergy to the studied drugs.
* Patients with contraindications to spinal anesthesia.
* Patients with advanced cardiac, renal, or hepatic diseases.
* Previous voiding difficulty.
* Patients taking anticholinergic medications.
* Time of surgery exceeds 75 min.

Primary outcomes:
measure: Time till home readiness
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Time to block regression
timeFrame: 6 hours postoperatively
measure: Time of onset of motor block
timeFrame: Intraoperatively
measure: Time to spontaneous voiding
timeFrame: 24 hours postoperatively
measure: Time to the 1st rescue analgesia
timeFrame: 24 hours postoperatively
measure: Total ketorolac consumption
timeFrame: 24 hours postoperatively
measure: Heart rate
timeFrame: Every 10 min till the end of surgery (up to 1 hour)
measure: Mean arterial pressure
timeFrame: Every 10 min till the end of surgery (up to 1 hour)
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT00491348: Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study
Official title: Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Worry
Anxiety
Keywords: Generalized anxiety disorder
fMRI
Worry
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2007-06-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: (1) to compare the differences of neural activation of pathological worry between pre-treatment GAD patients and normal subjects; (2) to measure the differences of brain activation on worry in GAD patients before and after duloxetine treatment

Detailed description: The study will recruit 20 GAD patients and 20 healthy controls. Both patients and controls receive a medical and psychiatric screening procedure at visit 1 and are asked to complete three self-rating questionnaires and one health questionnaire at visit 1. All qualified participants will receive functional magnetic resonance imaging (fMRI) at baseline.

The patients will begin treatment with duloxetine 30 mg/day at visit 2 and will be titrated to 60 mg/day at visit 3 (2 week since drug dispensed). The dosage will be maintained on 60 mg/day for 6 more weeks. During the period, the patients will receive periodic evaluations at visit 2 (0 week drug dispensed), 3 (2 week since drug dispensed), 4 (4 weeks since drug dispensed), and 5 (8 weeks since drug dispensed). The patients will receive fMRI examination at baseline and at the end of the 8-week treatment.

Eligibility criteria: Inclusion Criteria:

* DSM-IV criteria of generalized anxiety disorders with moderate degree
* Participants above 18 years old

Exclusion Criteria:

* Major depression
* Panic disorder
* Obsessive-compulsive disorder
* Post-traumatic disorder
* Eating disorders
* Psychotic disorders; and
* Alcohol or other substance use disorders
* Neurological disease
* Cardio-vascular disease
* Respiratory disease
* Head trauma

Primary outcomes:
measure: difference of brain activation on worry
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: NTUH
name: Mei-Chih Tseng, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04742348: Research on Translational Outcomes of Alcohol (Project RETRO)
Official title: Research on Translational Outcomes of Alcohol (Project RETRO)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Alcohol Drinking
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the current study is to assess the effect of a single dose of carbidopa-levodopa on ad libitum alcohol consumption and alcohol craving in young adults with a history of binge drinking.

Detailed description: This is a small (N = 42) 2-arm, double-blind, randomized controlled pilot study to assess the effect of a single dose of immediate release carbidopa-levodopa (50mg/500mg) to acutely reduce alcohol consumption and craving in college students with a history of heavy episodic drinking. Participants will be between 21-24 years old from 2- and 4- year colleges in the Seattle Metropolitan area. Interested students will contact the study line and provide verbal consent to be sent a link to an online screening survey. Eligible participants will be scheduled to come in for the ad libitum alcohol administration. Participants will receive either the carbidopa-levodopa or a placebo and complete the alcohol administration protocol.

Eligibility criteria: Inclusion Criteria:

* Enrolled in 2- or 4-year college program
* Currently living in the Seattle Metropolitan area
* Have at least two or more episodes of heavy episodic drinking (4/5 or more drinks in a 2 hours for women/men) in the past 30 days.

Exclusion Criteria:

* Exclusion criteria include:
* past-month severe alcohol or other substance use disorders,
* mood or anxiety disorder
* suicidal ideation
* risk of psychotic disorders
* excessive alcohol use reaching a Blood Alcohol Level greater than .30%
* history of serious medical conditions, regular use of prescription psychotropic or pain medication
* history of negative reactions to alcohol
* history of treatment for alcohol use disorder
* pregnancy or nursing.
* use of non-selective monoamine oxidase inhibitors in the past 2 weeks.
* narrow-angle glaucoma
* undiagnosed skin lesions,
* have a history of melanoma, cardiac issues or peptic ulcer.
* Currently taking or prescribed any form of levodopa or D2 agonists, D2 antagonists, isoniazid, methylphenidate, bupropion, Viagra, or phosphodiesterase inhibitors.

Primary outcomes:
measure: Alcohol Consumption
timeFrame: 1 hour
measure: Alcohol Craving
timeFrame: 30 minutes in to alcohol administration
Secondary outcomes:
measure: Alcohol craving
timeFrame: At the end of alcohol administration. Alcohol administration is 1 hour.
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Brittney Hultgren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01337648: Radiation Biodosimetry in Children Undergoing Total Body Irradiation
Official title: Radiation Biodosimetry in Children Undergoing Total Body Irradiation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total-body Irradiation
Hematopoietic Stem Cell Transplant
Keywords: Fecal biomarkers
Radiation biodosimetry
Total-body irradiation (TBI)
Hematopoietic stem cell transplantation
Gene expression profiles
Fecal metabolites
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2011-04-19
Enrollment: 2
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing Total Body Irradiation (TBI) preceding hematopoietic stem cell transplantation.

Brief summary: The purpose of this study is to develop fecal tests that will determine the extent of radiation exposure in patients undergoing radiation treatment for cancer. This project will determine whether fecal biomarkers can be used to diagnose exposure to radiation.

Detailed description: Patients undergoing TBI as part of a hematopoietic stem cell transplant (HSCT) will have feces collected for use in the validation and refinement of new methods for rapid radiation biodosimetry. The stool samples will be collected before, and at defined times after TBI. Stool sampling will occur in the same manner that it does during routine patient care during HSCT.

Eligibility criteria: Inclusion Criteria:

* All races are eligible
* 2 years to 21 years old
* Must be undergoing hematopoietic stem cell transplantation (either autologous or allogeneic) in conjunction with a conditioning regimen that includes total-body irradiation (TBI) (single or multiple fraction).

Primary outcomes:
measure: To describe changes in gene expression associated with exposure to radiation
timeFrame: prior to TBI treatment (baseline) and up to 2 weeks following the last dose of TBI
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: John Baker, MD
role: PRINCIPAL_INVESTIGATOR
References: