louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00602953: Role of Pancreatic Triglyceride Content in Beta-cell Function
Official title: Role of Pancreatic Triglyceride Content in Beta-cell Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Type 2 Diabetes
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-01-28
Enrollment: 101
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We enroll adult volunteers of all ethnicities who have no contraindications to the study procedures or use medications that interfere with our measurements.

Brief summary: The study evaluates if fat accumulates in the pancreas in individuals at risk of developing obesity-related diabetes. It also evaluates if the amount of fat in the pancreas can predict the residual functional capacity of the pancreas (insulin secretion).


Eligibility criteria: Inclusion Criteria:

* adults without prior history of pancreatic disease (other than diabetes)

Exclusion Criteria:

* use of unapproved medications
* contraindications to the MRI procedure
* contraindications to frequent blood draws
* pregnancy
* use of more than 2 alcoholic drinks/day

Primary outcomes:
measure: Pancreatic and Liver Fat
timeFrame: Within 1 month after screening visit.
measure: Beta-cell Function; AIRg - Acute Insulin Response to Glucose
timeFrame: At screening visit.
measure: Insulin Sensitivity (SI)
timeFrame: At screening visit.
measure: Disposition Index (DI)
timeFrame: At screening visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Ildiko Lingvay, MD, MPH, MSCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05151653: A Study to Test How Well Healthy Men Tolerate BI 765250 When Given as an Infusion Into the Vein or as an Injection Under the Skin
Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Intravenous Infusion or Subcutaneous Injection Doses of BI 765250 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-12-09
Enrollment: 139
Sex: MALE
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 main objectives of this trial are to investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses of BI 765250.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Chronic or relevant acute infections Further exclusion criteria apply

Primary outcomes:
measure: Percentage of subjects with treatment-emergent adverse events assessed as drug-related by the investigator
timeFrame: Up to 172 days
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: Up to 169 days
measure: Maximum measured concentration of the analyte in serum (Cmax)
timeFrame: Up to 169 days
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: SGS Life Science Services - Clinical Research
Study officials:
References:
Clinical trial NCT05368753: Evaluation of Plasma Concentrations of Intravenous Lidocaine and Epidural Ropivacaine When Used in Combination in Major Abdominal Surgery
Official title: Evaluation of Plasma Concentrations of Intravenous Lidocaine and Epidural Ropivacaine When Used in Combination in Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abdominal Surgery by Laparotomy
Thoracic Epidural Analgesia
Analgesia
Lidocaine Adverse Reaction
Keywords: Abdominal surgery by laparotomy
thoracic epidural analgesia
Analgesia
Lidocaine Adverse Reaction
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Thoracic epidural analgesia (TEA) is the gold standard analgesia of the laparotomy in major abdominal surgery and can be associated with intravenous lidocaine or subtituted by intravenous lidocaine when TEA is contraindicated and in order to reduce the use of the morphinics in the perioperative period.

Side effects can be paralytic ileus or nausea and vomiting and delay the enhanced recovery after surgery.

Intravenous lidocaine and TEA share several properties like anti hyperalgesia, anti inflammatory effect, intestinal process, anti tumoral effect... which suggests an additive effect of their combination that was not studied yet.


Eligibility criteria: Inclusion Criteria:

* Abdominal surgery by laparotomy

Exclusion Criteria:

* laparoscopic abdominal surgery,
* TEA contraindication,
* ropivacaine contraindication
* intravenous lidocaine contraindication

Primary outcomes:
measure: Blood lidocaine concentration (micrograms/ml)
timeFrame: 30 minutes before the end of surgery
measure: blood lidocaine concentration (micrograms/ml)
timeFrame: at the end of the surgery (assessed up to 2 hours)
measure: blood lidocaine and ropivacaine concentration (micrograms/ml)
timeFrame: at 2 hours
measure: blood ropivacaine concentration (micrograms/ml)
timeFrame: at 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT06810453: The Effects of Sevoflurane and Desflurane Used in Low-Flow Anesthesia on Thiol Disulfide Homeostasis
Official title: The Effects of End-tidal Controlled Low-Flow Anesthesia on Anesthetic Agent Consumption in Elective Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Flow Anesthesia
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study aimed to compare the effects of sevoflurane and desflurane used in low-flow anesthesia on thiol-disulfide homeostasis of patients undergoing general anesthesia.

Detailed description: Fifty patients were included who were scheduled to undergo elective total thyroidectomy operation under general anesthesia. The patients were assigned to one of 2 groups. Group S was the low-flow sevoflurane anesthesia group and Group D was the low-flow desflurane group. Blood samples were collected to evaluate thiol disulfide homeostasis preoperatively and postoperatively.

Eligibility criteria: Inclusion Criteria:

* Patients who were scheduled to undergo elective total thyroidectomy under general anesthesia

Exclusion Criteria:

* Patients with diabetes mellitus, alcohol or drug addiction, smoking habits, expected difficult intubation, morbid obesity, chronic obstructive pulmonary disease, cardiovascular disease and those in pregnancy or lactation period were excluded from the study.

Primary outcomes:
measure: Serum thiol-disulfide homeostasis parameters measurement/ calculation
timeFrame: A 5 cc venous blood sample was obtained just before the anesthesia induction and at the end of surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Elzem Sen
state: Sehitkamil
Study officials:
affiliation: University of Gaziantep
name: Elzem Sen, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05969353: Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study
Official title: Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study in Participants Who Hospitalized in Department of Internal Medicine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-08-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized sham controlled study that will include patients hospitalized in the internal medicine department and the orthopedics department at Bnei Zion Hospital presenting with pain from various sources with an NRS level equal to or above 4.

Detailed description: All patients will complete pain assessment according NSR and ESAS after treatment ( SHAM or BFA) one hour before and every 24 hours until discharge.

If there was no sufficient improvement in pain within 24 hours (decrease of 1.5 points or more in NRS) - additional acupuncture will be performed in the contralateral ear and repeated assessments as above.

Eligibility criteria: Inclusion Criteria:

-1.Pain of skeletal muscle origin (Musculoskeletal MSK)/rheumatological/orthopedic syndromes 2.Visual Analog Score (VAS) grade 4 or higher before receiving the treatment.

3.Eligible to participate in the study according to the assessment of the investigator

Exclusion Criteria:

1. Pain syndromes of non-muscular bony/rheumatological/orthopedic origin
2. Planned an MRI next week
3. An infectious process in the ear planned for acupuncture or a history of sensitivity to metal
4. have any participant condition that ' according to the Investigator ' could interfere with the conduct of the trial -

Primary outcomes:
measure: efficacy of BFA
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: BnaiZion MC
Study officials:
affiliation: BnaiZion MC
name: shira ginsberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01883453: A Nasal Spray With Glucose Oxidase as a Treatment of Common Cold
Official title: A Double Blinded Clinical Study Aiming to Shorten an Episode of Common Cold When the Treatment is Started at the Onset of an Episode of Common Cold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Common Cold
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Healthy persons are invited to participate in the study and are given a home protocol (WURSS21), nasal spray and a sample pin. The included persons are told to make a nasopharyngeal sampling from the nose when they are sure that they have caught a common cold. After the sampling they start to spray and also fill in the records daily. The aim of the study is to investigate whether a nasal spray with glucose oxidase could shorten an episode of common cold.

Detailed description: Persons working in a military unit in Boden and persons connected to the Department of Sports Medicine in Umeå were invited to participate in this study. Only persons older than 18 years was included in the study. The persons included received one bottle of study medicine, a home protocol (WURSS 21) and a viral sampling kit. Whenever the included persons were sure that they had received an episode of common cold they were told to perform a viral sampling from the nose, fill in the protocol and start to use the nasal spray several times daily for one week. The treatment was either a) a saline solution with 5% glucose or b) a saline solution with 200U/ml of glucose oxidase and 5%glucose (active treatment group). The combination of glucose oxidase and glucose produces an acid environment, imitating the effect of the normal nasal flora and Human Rhinoviruses are sensitive to an acid environment. After one week of treatment and daily records of the WURSS 21 protocol the persons returned the spray bottles (Bag-on-Valve), the virus vials and the protocols.

A total of 146 persons were included in the study and 98 persons returned protocols.

Eligibility criteria: Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Ongoing allergy

Primary outcomes:
measure: Reducing Symptoms of a Common Cold
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Boden
country: Sweden
facility: Försvarshälsan
city: Umeå
country: Sweden
facility: Idrottsmedicin
Study officials:
affiliation: Umeå University
name: Krister Tano, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03988153: Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function
Official title: Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function in Mild Hypercholesterolemic Volunteers: A Placebo-control, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Probiotics
cholesterol
LDL-c
Hypercholesterolemic
Fecal movement
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, placebo-controlled, randomized parallel clinical trial
Primary purpose: TREATMENT

Brief summary: Probiotic contained milk formula (PMF) intervention for 10 weeks considerably improves gastrointestinal function by modulating fecal movement, intestinal microflora as well as decrease cholesterol and thus help in the management of hypercholesterolemia.

Detailed description: Current randomized placebo-controlled, double-blind was designed to assess the effect of probiotic contained milk formula (PMF) on lipid profile and intestinal function in healthy mild hypercholesterolemic subjects. Totally forty healthy mild hypercholesterolemic subjects (180-220 mg/dL) were randomly chosen and divided into two groups as placebo or experimental group. All the subjects were requested to drink either PMF (experimental) or skimmed milk drink formula-Placebo (30 gm mixed with 200 mL of water) for 10 weeks and continued by 2 weeks of the follow-up period. Supplementation of PMF for 10 weeks significantly improved (p\< 0.05) the fecal weight, fecal movement (decreased fecal GI passing time) by improving intestinal microflora (increasing beneficial bacterial species like Lactobacillus, Bifidobacterium spp) and Lag time of LDL oxidation. In addition, intake of PMF substantially reduced (p\< 0.05) the levels of total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-c) and thus showcasing its cardioprotective efficacy. Therefore PMF is recommended for the management of hypercholesterolemia.

Eligibility criteria: Inclusion Criteria:

* healthy mild hypercholesterolemic subjects (180-220 mg/dL)

Exclusion Criteria:

* Subjects who took antibiotics or supplements (vitamins or minerals), probiotics (especially dairy products), Subjects suffering from severe gastrointestinal, cardiovascular, hepatic or renal disorders, Lactating or pregnant women, chain smokers.

Primary outcomes:
measure: Fecal Characteristics
timeFrame: 12 weeks
measure: Intestinal microflora
timeFrame: 12 weeks
Secondary outcomes:
measure: Lipid profile
timeFrame: 12 weeks
measure: Lag time of LDL oxidation
timeFrame: 12 weeks (5 min incubation)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03232853: E-learning to Prevent Drug Errors in Anesthesia
Official title: Evaluation of an E-learning to Prevent Drug Errors in Anesthesia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Errors : Drugs Errors During Anesthesia
Keywords: medical error in anesthesia
drug error in anesthesia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing anesthesia in Lapeyronie Hospital

Brief summary: The purpose of this observational study is to assess the efficiency of an e-learning in order to put into practice some preventive measures to avoid medication errors during anesthesia.

Detailed description: Before the study, the investigators selected 15 preventive measures to avoid medication errors during anesthesia. These measures were learned to the entire anesthesia team (nurse, resident and anesthesiologist) during conventional meetings. An initial evaluation of the application of these measures will be carried out before the introduction of e-learning. This assessment will be conducted by nurses without the knowledge of the anesthetic team evaluated. After this initial evaluation, e-learning will be broadcast on the hospital intranet. Then a second evaluation of the application of the preventive measures will be carried out 6 month and 1 year after the introduction of e-learning.

Eligibility criteria: Inclusion criteria:

* patient undergoing regional and/or general anesthesia

Exclusion criteria:

* only sedation

Primary outcomes:
measure: Percentage of application of the preventive measures after versus before the use of an e-learning.
timeFrame: 1 day
Secondary outcomes:
measure: Evaluation of the application of each of the 15 preventive measureaccording to various clinical parameters
timeFrame: 1 day
Other outcomes:
measure: Evaluation of the application of the preventive measures following the introduction of the e-learning in the anesthesia team.
timeFrame: 6 month and 1 year
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: BIBOULET Philippe, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02329353: Effect of Probiotics on Chronic Periodontitis in Smoker and Non- Smokers
Official title: Clinical And Microbiological Analysis Of Orally Administered Lactobacillus Probiotic Lozenges In Chronic Periodontitis Patients Among Smokers And Non-smokers And Its Correlation With Clinical Parameters - A Clinico-Microbiological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Periodontitis
Lead sponsor: Next Gen Pharma India Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Krishnadevaraya College of Dental Sciences & Hospital
First posted: 2014-12-31
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Periodontitis is one of the most common chronic inflammatory disease with the etiology of bacterial plaque and is associated with a number of putative bacterial species. The periodontal destruction is substantially mediated by the host, driven by the bacterial challenge. The presence of pathogenic bacteria with the absence of so-called "beneficial bacteria" and the susceptibility of the host are the main aetiological factors of periodontal diseases.


Eligibility criteria: Inclusion Criteria:

* Patients free from any systemic illness
* Previously untreated moderate to severe generalised chronic periodontitis.
* Patients free from adverse reactions to lactose or fermented milk products
* Patient unwilling to quit smoking and smokers over the past one year ( Smoker arm).

Exclusion Criteria:

* Previous history of antibiotic usage over past 6 months
* Patients who are eligible for antibiotic usage during the treatment course
* Patients who are pregnant, lactating, alcoholic or who had undergone any surgical or nonsurgical therapy within 6 months.
* Acute oral lesions or necrotising ulcerative periodontitis

Primary outcomes:
measure: Improvement in Clinical Periodontal Indices
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in microbiological indices
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaraya College of Dental Sciences and Hospital
state: Karnataka
Study officials:
affiliation: KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE
name: Rudrakshi chickanna, MDS
role: PRINCIPAL_INVESTIGATOR
affiliation: KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE
name: Shruthi J R, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE
name: Prabhuji MLV, MDS
role: PRINCIPAL_INVESTIGATOR
References: