louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02516098: Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.
Official title: A Single Center, Single-dose, Double-blind, Randomized, Two Period Crossover, Two Stage Design to Determine Bioequivalence of Two Formulations Containing Hyoscine Butylbromide 10mg Sugar Coated Tablets, Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-08-05
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated tablets.


Eligibility criteria: Inclusion criteria:

healthy males and females, aged 18-50years, BMI 18,5-30

Exclusion criteria:

History of hypersensitivity or allergy to IMP

Primary outcomes:
measure: Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)
timeFrame: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter
measure: AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t)
timeFrame: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter
Secondary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞).
timeFrame: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter
measure: Area Under the Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product and the Test Product (AUCReftmax)
timeFrame: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter
Other outcomes:
Locations:
city: Bloemfontein
country: Canada
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT04404998: The Influence of Energy Density and Information on Meal Intake in Adults
Official title: Lunch Meal Study for Men and Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Feeding Behavior
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to gain a better understanding of how energy density and cognitive framing of satiation using food information can influence consumption at a meal. This study also aims to investigate the influence of energy density and food information on sensory specific satiety (the decline in the subjective pleasantness of a food as it is eaten).


Eligibility criteria: Inclusion Criteria:

* Ability to attend all test meals
* Be fully vaccinated against COVID-19
* Regularly eat 3 meals/day
* Being willing to avoid alcohol the day before and during test days
* Have a body mass index greater than 18.0 kg/meters squared
* Being willing to refrain from eating after 10 pm the evening before test sessions

Exclusion Criteria:

* Being a smoker
* Being an athlete in training
* Being pregnant or breastfeeding at the time of screening
* Have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months
* Dislike or inability to eat the test foods
* Currently dieting to gain or lose weight
* Have a health condition that affects appetite
* Have participated in a similar study in our lab in the past year
* Being a student, faculty, or staff member in nutritional sciences or psychology

Primary outcomes:
measure: Change in food intake by weight
timeFrame: Weeks 1, 2, 3, 4
measure: Change in energy intake
timeFrame: Weeks 1, 2, 3, 4
Secondary outcomes:
measure: Change in palatability rating of food samples
timeFrame: Weeks 1, 2, 3, 4
measure: Change in prospective consumption rating of food samples
timeFrame: Weeks 1, 2, 3, 4
measure: Change in hunger rating
timeFrame: Weeks 1, 2, 3, 4
measure: Change in fullness rating
timeFrame: Weeks 1, 2, 3, 4
measure: Change in test meal prospective consumption rating
timeFrame: Weeks 1, 2, 3, 4
measure: Change in test meal fillingness rating
timeFrame: Weeks 1, 2, 3, 4
measure: Change in test meal palatability rating
timeFrame: Weeks 1, 2, 3, 4
measure: Change in estimation of proportion of test meal consumed
timeFrame: Weeks 1, 2, 3, 4
measure: Change in estimation of energy content of test meal consumed
timeFrame: Weeks 1, 2, 3, 4
Other outcomes:
Locations:
city: University Park
country: United States
facility: Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03030898: Analysis of Respiratory Variations of the Right Internal Jugular Vein as a Predictor of Fluid Responsiveness During Mechanical Ventilation
Official title: Analysis of Respiratory Variations of the Internal Jugular Vein as a Predictor of Fluid Responsiveness During Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Jugular Veins
Ultrasonography
Lead sponsor: Military Hospital of Tunis
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The idea of this work came during a carotid surgery, when we noticed a respiratory variation of the right internal jugular vein. Also, because of the interest of evaluating the preload dependence during an intervention or reanimation where it is difficult to access the other monitoring methods . The aim of the study was to test the hypothesis that respiratory changes in right internal jugular vein diameter are similar to respiratory changes in superior and inferior vena cava in mechanically ventilated patients and therefore help to predict fluid responsiveness.


Eligibility criteria: Inclusion Criteria:

* older than 18 years
* Mechanical Ventilation

Exclusion Criteria:

* no exclusion Criteria

Primary outcomes:
measure: Respiratory Variation of the Right Internal Jugular Vein ∆DRIJV
timeFrame: through study completion, an average of 1 year
measure: Respiratory Variation of the superior vena cava ∆DSVC
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Respiratory Variation of the inferior vena cava ∆DIVC
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Military Hospital of Tunis
name: Anis Lebbi
role: STUDY_DIRECTOR
affiliation: Military Hospital of Tunis
name: Mejdi Ferjaoui
role: PRINCIPAL_INVESTIGATOR
affiliation: Military Hospital of Tunis
name: Trabelsi Walid
role: STUDY_CHAIR
affiliation: Military Hospital of Tunis
name: Abdelkader Ben Gabsia
role: STUDY_CHAIR
affiliation: Military Hospital of Tunis
name: Emel Rafrafi
role: STUDY_CHAIR
affiliation: Military Hospital of Tunis
name: Amine Skouri
role: STUDY_CHAIR
affiliation: Military Hospital of Tunis
name: Kaouther Fares
role: STUDY_CHAIR
affiliation: Military Hospital of Tunis
name: Walid Sallami
role: STUDY_CHAIR
affiliation: Military Hospital of Tunis
name: Iheb Labbene
role: STUDY_CHAIR
affiliation: Military Hospital of Tunis
name: Mustapha Ferjani
role: STUDY_CHAIR
References:
Clinical trial NCT01478698: The Safety and Tolerability of Intra-abdominal t-PA and DNase on Peritonitis in Peritoneal Dialysis Patients
Official title: A Phase 1, Open Label, Non Randomised Safety Trial of Intraperitoneal tPA and DNase in Peritoneal Dialysis Patients With Peritonitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Peritoneal Dialysis
Peritoneal Dialysis, Continuous Ambulatory
Keywords: peritoneal dialysis
peritoneal dialysis, continuous ambulatory
peritonitis
Lead sponsor: Sir Charles Gairdner Hospital
Sponsor class: OTHER
Collaborators: name: The University of Western Australia
First posted: 2011-11-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothesis:

Intraperitoneal tPA and DNase is well tolerated at a number of different doses. Different doses of tPA and DNase will have a dose-related effect on inflammatory markers (CRP and intraperitoneal white cell count).

Aims:

1. To examine the tolerability of different doses of intraperitoneal tPA and DNase compared to standard treatment.
2. To examine the changes in biochemical and clinical outcomes of PD Peritonitis with the addition of intraperitoneal tPA and DNase to usual therapy.


Eligibility criteria: Inclusion Criteria:

1. PD patient
2. Proven peritonitis (as defined as at least 2 of: (i) Symptoms and/or signs of peritonitis; (ii) Cloudy dialysate OR dialysate white cell count \> 100x 106/L with \>50% neutrophils; (iii) Positive culture of dialysate
3. Age \> 18 years old

Exclusion Criteria:

1. More than one organism on culture
2. Contra-indication for systemic thrombolysis (eg. current or recent stroke, major haemorrhage or major trauma; proliferative retinopathy; major surgery in the previous 5 days)
3. Known sensitivity to DNase or t-PA
4. Pregnancy or lactating mother
5. Expected survival less than 3 months
6. Clinical indication for PD catheter removal, as defined by treating team
7. Inability to provide written informed consent
8. Systemic anticoagulation
9. Severe uncontrolled hypertension
10. Documented ulcerative gastrointestinal disease during the last three months

Primary outcomes:
measure: Adverse reactions
timeFrame: 72 hours
Secondary outcomes:
measure: Biochemical markers of inflammation
timeFrame: 21 days
measure: Clinical markers of inflammation
timeFrame: 21 days
Other outcomes:
measure: Additional variables
timeFrame: 3 months
Locations:
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
Study officials:
affiliation: Sir Charles Gairdner Hospital
name: Aron Chakera, DPhil
role: STUDY_DIRECTOR
References:
Clinical trial NCT06757998: On-lay Versus Pre-peritoneal Hernioplasty in Incisional Lumbar Hernia
Official title: On-lay Versus Pre-peritoneal Hernioplasty in Incisional Lumbar Hernia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lumbar Hernia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: • Conventional Sample size of about 30 Cases about 15 cases of each group

Brief summary: To compare between the outcome of on-lay and pre-peritoneal techniques of hernioplasty in incisional lumbar hernia repair.

Detailed description: Lumbar hernia is found as a challenge even in the era of advanced medicine, due to its rarity which complicate its diagnosis and treatment\[1\]. Lumbar hernia is the protrusion of an organ intra-peritoneal or extra-peritoneal tissue through a congenital or acquired defect in the posterolateral abdominal wall\[2\]. Incisional Lumbar hernia is among the types of lumbar hernia that accounts for 25% of cases\[3\]. Post abdominal surgeries, the tissue strength can only regain 80% of its maximum tensile power under perfect conditions. Thus, each abdominal surgery is a predisposing factor for lumbar incisional hernia \[4\] Primary closure of the defect with sutures, has proven to have a high failure rate so the integration of the mesh in hernia repair has significantly flattened the recurrence curve. Taking the advantage of Laplace's law, the mesh aims to reinforce or bridge the defect and distribute the intra-abdominal pressure across the entire synthetic sheet rather than just the defect. \[5\] The two most used mesh placing techniques are on-lay and pre-peritoneal. Each method has its benefits and drawbacks. \[6\] Some surgeons outweigh the on-lay technique to avoid extensive dissection. Thus, it is a faster and easier technique; nevertheless, there are several local wound issues. \[7\] The pre-peritoneal method allows the surgeon to apply the mesh posterior to the fascial plane in front of the peritoneum. The latter technique is gaining popularity with time \[8\]

Literature are deficient in comparing on-lay and pre-peritoneal technique in the repair of incisional lumbar hernia.

Eligibility criteria: Inclusion Criteria:

* Incisional lumbar hernia
* Recurrent lumbar hernia
* Age more than 16 years old

Exclusion Criteria:

* Complicated lumbar hernia (irreducible, obstructed, strangulated hernia)
* Denovo lumbar hernia

Primary outcomes:
measure: Short term complications (Recurrence, Postoperative Seroma and skin infection.)
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00062998: Free-Living Physical Activity and Energy Expenditure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-06-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: We have recently validated a new device for measurement of physical activity and found it to detect type, duration and intensity of many types of physical activity at better than 98% accuracy. After further validating this device to determine if it can also accurately assess energy expenditure, we will use it to collect cross-sectional data on free-living physical activity and energy expenditure in adolescent girls.


Eligibility criteria: Study3: healthy lean and obese adults, at least 18 years of age.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital Center
state: New York
Study officials:
References:
Clinical trial NCT05498298: A Clinical Study to Investigate the Reliability of Fetal Heart Rate and Maternal Heart Rate Signals Extracted From Biopotential Data
Official title: A Cross-sectional, Interventional, Exploratory Clinical Study to Investigate the Reliability of Fetal Heart Rate and Maternal Heart Rate Signals Extracted From Biopotential Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Bloom Technologies
Sponsor class: INDUSTRY
First posted: 2022-08-12
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Bloom Technologies is developing a wearable device for monitoring pregnancy.

In this study, Bloom Technologies wants to investigate the reliability of this new technology.

For this reason, a device that records very high-quality data (g,Hlamp) was chosen. The study device is attached to the body by means of electrodes (up to 32) that can be safely attached to the skin. Most of the electrodes are placed on the abdomen, and a few on the chest and back.


Eligibility criteria: Inclusion Criteria:

* Pregnant woman ≥ 18 years old
* Gestational age ≥ 30 weeks and 0 days
* Singleton pregnancy
* Ability to read and understand English or Spanish
* Willingness to participate in the study

Exclusion Criteria:

* Implanted pacemaker or any other implanted electrical device
* History of allergies to skin adhesives
* Irritated or lesioned skin at the electrodes locations

Primary outcomes:
measure: Reliability in fetal heart rate extraction
timeFrame: 40 minutes
measure: Reliability in maternal heart rate extraction
timeFrame: 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Valley Perinatal Services
state: Arizona
Study officials:
affiliation: Valley Perinatal Services
name: Ravindu Gunatilake
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01067898: A Study on Oral Vitamin D Megadoses
Official title: A Randomized, Double-blind, Placebo-controlled Study on Oral Vitamin D Megadoses - 100 000 or 200 000 IU Vitamin D3 Every Three Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypovitaminosis D
Keywords: vitamin D supplementation
cholecalciferol
PTH
bone turnover markers
elderly women
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2010-02-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if infrequent administration of oral vitamin D megadoses is effective treatment to maintain serum 25-hydroxyvitamin D(3) above target levels of 50-75 nmol/L. The investigators hypothesize that 100 000 IU or at least 200 000 IU vitamin D3 in every three months would be effective and safe treatment to achieve the target levels.


Eligibility criteria: Inclusion Criteria:

* female
* 70-80 yrs old

Exclusion Criteria:

* disease or medication affecting calcium homeostasis
* renal failure (Pt-GFRe-CG \< 35 ml/min)

Primary outcomes:
measure: Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L
timeFrame: 12 months (including 9 time points)
Secondary outcomes:
measure: Decline of creatine clearance (Pt-GFRe-CG) >20% from baseline
timeFrame: 12 months (including 9 timepoints)
measure: Hypercalciuria (dU-Ca >10 mmol/24h)
timeFrame: 12 months (including 9 timepoints)
measure: Hypercalcemia (S-Ca-ion >1,3 mmol/l)
timeFrame: 12 months (including 9 timepoints)
measure: Serum PTH
timeFrame: 12 months (including 9 timepoints)
measure: Serum PINP
timeFrame: 12 months (including 5 timepoints)
measure: Serum CTX
timeFrame: 12 months (including 5 timepoints)
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital
Study officials:
References:
citation: Pekkarinen T, Valimaki VV, Aarum S, Turpeinen U, Hamalainen E, Loyttyniemi E, Valimaki MJ. The same annual dose of 292000 IU of vitamin D (cholecalciferol) on either daily or four monthly basis for elderly women: 1-year comparative study of the effects on serum 25(OH)D concentrations and renal function. Clin Endocrinol (Oxf). 2010 Apr;72(4):455-61. doi: 10.1111/j.1365-2265.2009.03637.x. Epub 2009 May 25.
citation: Valimaki VV, Loyttyniemi E, Valimaki MJ. Vitamin D fortification of milk products does not resolve hypovitaminosis D in young Finnish men. Eur J Clin Nutr. 2007 Apr;61(4):493-7. doi: 10.1038/sj.ejcn.1602550. Epub 2006 Nov 29.
citation: Valimaki VV, Alfthan H, Lehmuskallio E, Loyttyniemi E, Sahi T, Stenman UH, Suominen H, Valimaki MJ. Vitamin D status as a determinant of peak bone mass in young Finnish men. J Clin Endocrinol Metab. 2004 Jan;89(1):76-80. doi: 10.1210/jc.2003-030817.
Clinical trial NCT05069298: Effect of Silibinin(A) as a Potential Anti-obesity Agent
Official title: Effect of Milk Thistle Derivative Silibinin(A) as a Potential Anti-obesity Agent
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Hypercholesterolemia
Hypertriglyceridemia
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our preliminary reports have found in silico and in vitro that the milk thistle derivative Silibinin(A) is able to inhibit pancreatic lipase, in a similar way that the classical anti-obesity drug orlistat.

Therefore, the investigators want to carry out the present trial in order to confirm that Silibinin(A) is able to in vivo inhibit pancreatic lipase, which will reduce the fat absorption and therefore will decrease the amount of energy from food intake.

Considering that milk thistle has been extensively studied in humans as liver-protector, the investigators consider that the use of human subjects will be of great interest to accelerate the employment of this compound to improve the effectiveness of dietary treatment in overweight/obese subjects.


Eligibility criteria: Inclusion Criteria:

* BMI \> 24,9
* Voluntarily participate in the study

Exclusion Criteria:

* significant cognitive impairment
* psychiatric disorders
* chronic pharmacological treatment that may affect the effectiveness of the dietary intervention (corticosteroids, thyroid hormones, oral antidiabetic agents or lipid-lowering drugs)
* chronic disease that may interfere with dietary therapy (cancer, renal or hepatic impairment, chronic gastrointestinal conditions)
* acute disease episodes during the study
* subjects who followed a hypocaloric diet at the allocation time or in the 3 months prior to the beginning of the study
* pregnant women

Primary outcomes:
measure: Percentage of total body weight loss
timeFrame: 3 months
Secondary outcomes:
measure: Plasma total cholesterol
timeFrame: 3 months
measure: Plasma low density level cholesterol (cLDL)
timeFrame: 3 months
measure: Plasma triglycerides
timeFrame: 3 months
measure: Body mass index (BMI)
timeFrame: 3 months
measure: Body fat percentage
timeFrame: 3 months
measure: Waist circumference
timeFrame: 3 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Faculty of Nursing. Catholic University of Murcia
Study officials:
affiliation: Catholic University of Murcia
name: Juan José Hernández Morante, PhD
role: PRINCIPAL_INVESTIGATOR
References: