louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00779298: Effect of Commercial Rye Whole-Meal Bread on Postprandial Blood Glucose and Gastric Emptying in Healthy Subjects
Official title: Effect of Commercial Rye Whole-Meal Bread on Postprandial Blood Glucose and Gastric Emptying in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: rye whole-meal bread
white-wheat bread
gastric emptying rate
postprandial glucose response
healthy subjects
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2008-10-24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects were recruited from the population in a southern county of Sweden.

Brief summary: Increased intake of dietary fibre and whole grains is related to reduced risk of developing diabetes. The term "whole grain" is often used for whole-meal products in which the structure of the cereal grain is destroyed in the flour containing the original dietary fiber, but also for cereal products in which a large proportion of whole cereal grains is intact. The aim of this study was to evaluate the effect of commercial rye whole-meal bread (RWMB) compared to white-wheat bread (WWB) on gastric emptying rate (GER), postprandial glucose response in healthy subjects.

Detailed description: Ten healthy subjects, without symptoms or a prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus, were assessed by using a blinded crossover trial. The subjects were examined regarding blood glucose levels and GER after ingestion of 150g WWB or RWMB on two different occasions after an overnight fast. GER was measured using a standardized real time ultrasonography. GER was calculated as a percentage change in antral cross sectional area 15 and 90 minutes after the finished meal with WWB and RWMB. Finger-prick capillary samples were collected before and 40, 60, and 90 min after the start of the meal to measure blood glucose levels.

Eligibility criteria: Inclusion Criteria:

* without symptoms or a prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus

Exclusion Criteria:

* with symptoms or prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Dept. of Medicine, Malmö University Hospital,
state: Skåne
Study officials:
References:
citation: Hlebowicz J, Jonsson JM, Lindstedt S, Bjorgell O, Darwich G, Almer LO. Effect of commercial rye whole-meal bread on postprandial blood glucose and gastric emptying in healthy subjects. Nutr J. 2009 Jun 16;8:26. doi: 10.1186/1475-2891-8-26.
Clinical trial NCT02058498: Increasing Activity in Liver Transplant Patients
Official title: Increasing Physical Activity in Post Liver Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplant
Keywords: Liver transplant
Physical Activity
Quality of Life
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-02-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Will adult liver transplant patients who are provided with physical activity (walking) instructions increase their physical activity and perceive an improved quality of life?


Eligibility criteria: Inclusion criteria:

* Adult patients 18-65 years of age who receive a liver transplant at Mayo Clinic Jacksonville.
* Adult patients who are 5-21 days post liver transplant.
* Must be followed by Mayo Clinic Jacksonville at 4 months postoperatively.
* Approved by a hepatologist and/or transplant surgeon to participate.

Exclusion criteria:

* Patients with active infections
* Patients with encephalopathy or cognitive dysfunction
* Patients who receive a combined liver-kidney transplant
* Patients with severe debility
* Patients who require assistance to ambulate.

Primary outcomes:
measure: Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Quality of Life at Baseline, 6 Weeks, and 4 Months
timeFrame: Baseline, 6 weeks, 4 months
measure: Number of Patients Who Document Their Physical Activity
timeFrame: Baseline to 6 weeks, repeated measure at 4 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Jennifer Serotta, ARNP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04941898: A Study of TAK-660 in Surgical Procedures for People With Hemophilia A.
Official title: Adynovate Special Drug Use Result Survey (Perioperative Administration)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-06-28
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with blood coagulation factor VIII (FVIII) deficiency who received this drug during surgery or treatment after the start date of this survey.

Brief summary: This study is about a factor VIII medicine called Adynovate (TAK-660) used during surgery for people with hemophilia A who have low blood levels of factor VIII.

The aims of this study are as follows:

* To check for side effects from TAK-660.
* To check how well TAK-660 controls bleeding when used routinely during surgery and other invasive procedures such as tooth extractions.

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

During the study, participants will receive infusions of TAK-660 during their hospital stay for surgery according to their clinic's standard practice. The study doctors will check for bleeds and side effects from TAK-660 from surgery until discharge.


Eligibility criteria: Inclusion Criteria:

* Participants with blood coagulation factor VIII (FVIII) deficiency who received this drug during surgery or treatment after the start date of this survey.

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to 30 Days
measure: Number of Participants With Serious Adverse Events
timeFrame: Up to 30 Days
measure: Number of Participants With Adverse Drug Reaction
timeFrame: Up to 30 Days
measure: Number of Participants With Serious Adverse Drug Reaction
timeFrame: Up to 30 Days
measure: Number of Participants With Adverse Reactions Categorized as Inhibitor Development, Shock, or Anaphylaxis
timeFrame: Up to 30 Days
Secondary outcomes:
measure: Intraoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion
timeFrame: Day 1 (date of surgery)
measure: Postoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion 1 Day After Surgery
timeFrame: 1 Day post-surgery
measure: Postoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion at Completion of Perioperative Management
timeFrame: At completion of perioperative management (approximately 30 days after surgery)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05064098: Interpretations and Predictions of Patient Reported Outcomes by Breast Cancer Patients
Official title: Interpretations and Predictions of Patient Reported Outcomes by Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pre-surgical breast cancer patients and breast cancer survivors

Brief summary: This study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life.

Detailed description: This study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life. It will also provide the research team with improved understanding of how patients interact with and prefer to receive QOL information. Improved understanding of patient predictions and perceptions of information display will allow us to incorporate predicted future PROs into the shared decision making process as well as allow us to provide this important information to patients in a meaningful way.

Eligibility criteria: Inclusion Criteria:

* Pre-surgical female breast cancer patients
* Female breast cancer survivors

Exclusion Criteria:

-

Primary outcomes:
measure: Predicted patient reported outcomes up to 1 year after
timeFrame: 12 months
measure: Actual patient reported outcomes for each domain after surgery
timeFrame: 6 month
measure: Compare predicted and actual outcomes
timeFrame: 12 months
measure: Patients preferred method of communicating results
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hopspital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sarah Tevis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00901498: Relative Bioavailability Study of Four Experimental Formulations for Alzheimer's Disease
Official title: A Bioavailability Study of Four Experimental BMS-708163 Formulations Relative to Solubilized Capsule Formulation in Healthy Young Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Healthy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-05-13
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to assess the bioavailability of four experimental formulations relative to the current reference formulation used in the Phase 2 study.


Eligibility criteria: Inclusion Criteria:

* Young healthy male subjects

Exclusion Criteria:

* Women

Primary outcomes:
measure: To assess the bioavailability of 4 experimental formulations relative to the current reference formulation
timeFrame: Day 1, up to 3 weeks
Secondary outcomes:
measure: Safety: Adverse Events
timeFrame: Day 1, up to 3 weeks
measure: Safety: Vital Signs
timeFrame: Screening, Day 1 and Day 4 of each period
measure: Safety: ECGs
timeFrame: Screening, Day 1 of each period, up to 3 weeks
measure: Safety: Clinical Lab Tests
timeFrame: Screening, Day -1 of each period, Day 1, up to 3 weeks
Other outcomes:
Locations:
city: Neptune
country: United States
facility: Mds Pharma Services (Us) Inc.
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01765998: The Effect of Probiotics on Exacerbation of Inflammatory Bowel Disease Exacerbation (Crohn's Disease)
Official title: The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation (Crohn's Disease) and Markers of Inflammation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Crohn's Disease
Keywords: Crohn's disease, endothelial progenitor cells, probiotic
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2013-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Inflammatory Bowel Disease (IBD) is an immune mediated chronic intestinal condition. It includes ulcerative colitis (UC) and Crohn's disease(CD). probiotics have been shown to be effective in varried clinical conditions ranging fron infantile diarrhea, necrotizing enterocolitis,helicobacter pylori infections, etc.

Detailed description: This is a prospective study that will enroll 50 patients with Crohn's disease.Each patient will get the study medication for 6 weeks and will be evaluated twice- before enrollment and after 6 weeks of treatment.

Eligibility criteria: Inclusion Criteria:

* patients with Crohns' disease who are stable or have mild acute exacerbations that do not necessitate treatment with systemic corticosteroids

Exclusion Criteria:

* pregnant women, under 18 years or over 60 years,
* patients with known ulcerative colitis,
* patients with any cancer,
* patients with heart failure

Primary outcomes:
measure: endothelial stem cells
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Tiberias
country: Israel
facility: Baruch Padeh Medical Center
state: Lower galilee
Study officials:
affiliation: Baruch Padeh Medical Center
name: Arnon Blum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06974045: Impact of COVID-19 Pandemic on Single-stage Laparoscopic Cholecystectomy and Laparoscopic Common Bile Duct Exploration Service
Official title: Evaluation of a Single-stage Laparoscopic Cholecystectomy and Laparoscopic Common Bile Duct Exploration Service Pre-, Intra- and Post-COVID-19 Pandemic: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallstone
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 237
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that underwent the single-stage approach of LC + LCBDE for the management of choledocholithiasis, between April 2016 and February 2024. All patients were assessed with preoperative liver function tests (LFTs) and abdominal imaging such as ultrasound, computed tomography (CT) and/ or magnetic resonance cholangiopancreatography (MRCP).

Brief summary: Choledocholithiasis is reported to be present in 15-20% of patients with symptomatic gallstones. The single-stage management consists of performing either laparoscopic common bile duct exploration (LCBDE) or intraoperative endoscopic retrograde cholangiopancreatography (ERCP) at the same time as laparoscopic cholecystectomy (LC).

Since the Coronavirus (COVID-19) pandemic, surgical practice has significantly been impacted. The pandemic has had ramifications on patient and staff safety, surgical techniques, minimally invasive procedures, theatre workflow, education and training.

We analysed a series of LCBDE procedures in our institution pre-, intra- and post-COVID-19 pandemic to assess the feasibility, efficacy and safety of this single-stage treatment approach following the pandemic.


Eligibility criteria: Inclusion Criteria:

* Patients that underwent single-stage LC + LCBDE for the management of choledocholithiasis with concomitant gallstones.

Exclusion Criteria:

* Patients that underwent LC only or LCBDE only

Primary outcomes:
measure: Intraoperative measures
timeFrame: 90 days
measure: Postoperative complications
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01087645: A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects
Official title: Investigation of Safety, Tolerability and Bioavailability of NN9925 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-03-16
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability and bioavailability (exploring absorption of drug in body) of NN9925 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Male subjects with good general health as judged by the physician
* Body weight of 65-95 kg (both inclusive)
* Body Mass Index (BMI) of 18.5-27.5 kg/m2 (both inclusive)

Exclusion Criteria:

* Known or suspected allergy to trial product or related products
* Acute infection or inflammation or other illness that may confound the results of the trial or pose a risk to the subject by administering the trial product, as judged by the physician
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states of disease (celiac disease, lactose intolerance or chronic pancreatitis), as judged by the physician

Primary outcomes:
measure: Number and severity of adverse events (AEs) recorded
timeFrame: from dosing to Day 22
Secondary outcomes:
measure: The uptake in blood of oral NN9925
timeFrame: from 0 to 504 hours
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03314545: Clinical Evaluation of Laminate Veneers With Coronal Post Versus Post and Core Foundation Restoration With Single Crown for Restoration of Endodontically Treated Anterior Teeth (Randomized Controlled Trial) "In-vivo Study"
Official title: Clinical Evaluation of Laminate Veneers With Coronal Post Versus Post and Core Foundation Restoration With Single Crown for Restoration of Endodontically Treated Anterior Teeth (Randomized Controlled Trial) "In-vivo Study"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Teeth, Endodontically-Treated
Anterior Teeth
Keywords: endocrown
laminate veneer with coronal post
post and core
crown
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 35
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: Clinical evaluation of Laminate veneers with coronal post versus post and core foundation restoration with single crown for restoration of endodontically treated anterior teeth (Randomized Controlled Trial) "In-vivo Study"


Eligibility criteria: Inclusion Criteria:

1. From 18-60 years old, should be able to read and sign the consent document.
2. Ability to tolerate the restorative procedures (physical and psychological).
3. Patients with anterior endodontically treated teeth indicated for coronal restoration:

   1. Good oral hygiene
   2. Minimum remaining coronal tooth height of 4 mm
   3. Normal functional occlusal stresses within physiological limits.
   4. Adequate crown/root ratio
   5. No signs and symptoms related to active periapical pathosis or endodontic failure.
4. With no active periodontal or pulpal problems.
5. Willing to return for follow-up visits.

Exclusion Criteria:

1. Teeth not fully erupted as in young patients.
2. Poor oral hygiene and lack of motivation
3. Vital teeth
4. Psychiatric problems or unrealistic expectations
5. Excessive parafunctional stresses and bad habits like nail biting. 11
6. The absence of sound enamel margins for the preparation
7. Abnormally small teeth or with structural defects in enamel. 12
8. Tooth mobility or inadequate crown/root ratio.

Primary outcomes:
measure: Gross Fracture
timeFrame: one year
Secondary outcomes:
measure: marginal integrity
timeFrame: one year
measure: marginal discoloration
timeFrame: one year
measure: color match
timeFrame: one year
measure: caries
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06780345: Role of Vitamin C Infusion in Postoperative Mechanically Ventilated Neonates With Sepsis
Official title: Role of Vitamin C Infusion in Postoperative Mechanically Ventilated Neonates With Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin C
Postoperative
Mechanically Ventilation
Sepsis
Neonate
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 50
Sex: ALL
Minimum age (years): 37
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of intravenous vitamin C infusion on septic mechanically ventilated full-term neonates who underwent surgical interventions regarding mechanical ventilation parameters, time to wean, and the need for inotropic support.

Detailed description: Neonatal sepsis is a syndrome featuring non-specific signs and symptoms of systemic infection accompanied by bacteremia in the first 28 days of extrauterine life. This condition is a public health problem that still contributes to mortality and morbidity in neonatal intensive care units (NICUs) in high, as well as low- and middle-income countries.

Vitamins are essential micronutrients with key roles in many biological pathways relevant to sepsis. Some of these relevant biological mechanisms include antioxidant and anti-inflammatory effects, protein and hormone synthesis, energy generation, and regulation of gene transcription.

Vitamin C, ascorbic acid, is a water-soluble essential micronutrient commonly found in plants, especially fruits. When absorbed, it dissociates at physiological pH to form ascorbate, the redox state of the vitamin most commonly found in cells. In addition to being a potent antioxidant, vitamin C is a cofactor for enzymes involved in protein and hormone synthesis, metabolic pathways for energy generation, and regulation of gene transcription.

Eligibility criteria: Inclusion Criteria:

* Age more than 37 weeks.
* Both sexes.
* Neonates with sepsis are diagnosed both clinically and serologically after any surgical intervention.

Exclusion Criteria:

* Major congenital anomalies and Chromosomal abnormalities.
* neonate \<37weeks gestation.
* Hypoxic Ischemic Encephalopathy (HIE).
* Neuromuscular diseases.
* Intraventricular hemorrhage (IV Hge).

Primary outcomes:
measure: Duration of mechanical ventilation
timeFrame: 28 days from the start of ventilation
Secondary outcomes:
measure: Need for inotropic support
timeFrame: 28 days from the start of ventilation
measure: Mortality
timeFrame: 28 days from the start of ventilation
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: