louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04792762: Physiology of GIP(1-30)NH2 in Humans
Official title: Physiology of GIP(1-30)NH2 in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism Disorders
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 9
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Glucose-dependent insulinotropic polypeptide (GIP) is a gut-derived incretin hormone that affects glucose, lipid and bone metabolism. Secretion of GIP into the blood stream from enteroendocrine cells is stimulated bu nutrients in the gut lumen and results in potentiation of glucose stimulated insulin secretion from the pancreas. The objective of this study is to investigate the physiology of GIP(1-30)NH2 in humans with insulin secretion as the primary endpoint. Furthermore the effects on on plasma/serum levels of glucagon, C-peptide, glucose, bone markers (CTX and P1NP) will be measured.


Eligibility criteria: Inclusion Criteria:

* Healthy men of Northern European descent
* BMI: 19-25 kg/m2
* Stable body weight (±5%) in the last three months

Exclusion Criteria:

* Treatment with medication or dietary supplements that cannot be paused for 12 hours
* More than 14 units of alcohol per week or abuse of narcotics
* Established liver disease and/or plasma alanine aminotransferase (ALT) ≥3 × normal value and/or INR outside the normal range
* Renal impairment (eGFR \<60 ml/min/1.73 m2)
* Severe arteriosclerotic heart disease or severe heart failure (NYHA group III or IV)
* Low blood count (haemoglobin \<8.3 mol/l)
* Special diet or planned body weight change before the trial period
* First-degree relatives with diabetes
* Participation in other clinical experiments with medication
* Any disease/condition that the investigators estimate disturbing for the participation in the experiment

Primary outcomes:
measure: Insulin
timeFrame: Up to 3 months
Secondary outcomes:
measure: Glucagon
timeFrame: Up to 3 months
measure: C-peptide
timeFrame: Up to 3 months
measure: Glucose
timeFrame: Up to 3 months
measure: CTX
timeFrame: Up to 3 months
measure: P1NP
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Clinical Metabolic Physiology
Study officials:
References:
Clinical trial NCT00992862: A Relative Bioavailability Study of Moexipril HCl 15 mg Tablets Under Fasting Conditions
Official title: A Relative Bioavailability Study of Moexipril HCl 15mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Paddock Laboratories, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the relative bioavailability of Moexipril HCl 15mg tablets (by Paddock Laboratories, Inc.) with that of Univasc® 15mg tablets (by Schwarz Pharma) following a single oral dose (1 x 15mg tablet) in healthy, adult subjects under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening

Exclusion Criteria:

* Positive test results for HIV or Hepatitis B or C
* History of allergy or sensitivity to Moexipril HCl or related drugs

Primary outcomes:
measure: Bioequivalence according to US FDA guidelines
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburg
country: United States
facility: Novum Pharmaceutical Research Services
state: Pennsylvania
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Kennedy, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02802462: High-intensity Interval Training Enhances Mobilization/Functionality of Endothelial Progenitor Cells and Depressed Shedding of Vascular Endothelial Cells Undergoing Hypoxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Keywords: endothelial progenitor cell
hemodynamic
Exercise
HIIT
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Exercise training improves endothelium-dependent vasodilation, whereas hypoxic stress causes vascular endothelial dysfunction. Monocyte- derived endothelial progenitor cells (Mon-EPCs) contribute to vascular repair process by differentiating into endothelial cells. This study investigates how high-intensity interval (HIT) and moderate intensity-continuous (MCT) exercise training affect circulating Mon-EPC levels and EPC functionality under hypoxic condition. Sixty healthy sedentary males were randomized to engage either HIT (3-minute intervals at 40% and 80%VO2max , n=20) or MCT (sustained 60%VO2max , n=20) for 30 minutes/day, 5 days/week for 6 weeks, or to a control group that did not received exercise intervention (n=20). Mon-EPC characteristics and EPC functionality under hypoxic exercise (HE, 100W under 12%O 2 ) were determined before and after various interventions.


Eligibility criteria: Inclusion Criteria:

* Sedentary life
* Age 20\~28

Exclusion Criteria:

* Smokers
* Users of medication/vitamins
* Any cardiopulmonary/hematological risk
* Regular exercise habits at least 1 year
* Exposed to high altitudes (\>3000 m) for at least 1 year

Primary outcomes:
measure: Circulating progenitor cells conten
timeFrame: 6 weeks
Secondary outcomes:
measure: Cardiopulmonary fitness
timeFrame: 6 weeks
Other outcomes:
measure: Cardiac hemodynamic measurement
timeFrame: 6 weeks
measure: Cerebral hemodynamic measurement
timeFrame: 6 weeks
measure: Muscular hemodynamic measurement
timeFrame: 6 weeks
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Jong-Shyan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06615362: Autogenous Dentin Derived Barrier Membrane Versus Collagen Membrane
Official title: Autogenous Dentin Derived Barrier Membrane Versus Collagen Membrane for Guided Bone Regeneration in Immediate Implant
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: TOOTH EXTRACTION
IMMEDIATE IMPLANT
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms: one arm Autogenous Dentin Derived Barrier Membrane ,second arm Collagen Membrane .
Primary purpose: TREATMENT

Brief summary: Autogenous Dentin Derived Barrier Membrane versus Collagen Membrane

Detailed description: Autogenous Dentin Derived Barrier Membrane versus Collagen Membrane for Guided Bone Regeneration in Immediate Implant

Eligibility criteria: Inclusion Criteria:

1. Patient's age ranges from 18-50 years.
2. Adequate inter-arch relation and inter-occlusal space that could accommodate the implant abutment and the future restoration
3. Non-restorable tooth that needs dental extraction \&amp; guided bone regeneration for immediate implant.
4. Presence of alveolar bone defect with vertical loss of buccal bone more than a third implant thread.
5. Co-operative patients willing to complete the follow-up periods.

Exclusion Criteria:

1. Any pathological condition at site of surgery.
2. Patients with systemic diseases that contra-indicate the surgical procedure.
3. Heavy smoking.
4. Parafunctional habits such as bruxism and clenching.
5. Pregnant patients. -

Primary outcomes:
measure: All patients were evaluated radiographically immediately postoperative,and after 12 months
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University, faculty of dentistry ,Department of Oral and Maxillofacial
state: Eygpt
city: Mansoura
country: Egypt
facility: Elhussein Farag
state: Eygpt
Study officials:
affiliation: Mansoura University, faculty of dentistry ,Department of Oral and Maxillofacial
name: Heba Elsheikh Assistant professor, Assistant professor
role: STUDY_CHAIR
References:
Clinical trial NCT01679262: Determination of the Optimal Size of Oropharyngeal Airway; Correlation With External Body Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ear,Nose and Throat Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-09-05
Enrollment: 149
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: There are several studies that have measured various oropharyngeal airway space distances using radiological method. However, direct confirmation of optimal size of oropharyneal airways (OPAs) in individual using fiberoptic bronchoscope (FOB) is lacking as now. The purposes of this study were to directly determinate the proper size of OPA in individual by FOB via different sizes of OPA in adults under general anestheisia. Additionally, we examine the relationships among the size of OPA, straight length from the incisors to the tip of the epiglottis by laryngoscopy, patient height, and external facial measurements.


Eligibility criteria: Inclusion Criteria:

* ASA class I-II 2. 20-70 years adults

Exclusion Criteria:

* 1. an abnormal airway anatomy in preoperative radiologic study.
* 2. cervical spine pathology,
* 3. a history of difficult intubation,
* 4. neurologic disease or cardiovascular disease,
* 5. obesity (body mass index ≥ 30 kg m-1),
* 6. dental problem

Primary outcomes:
measure: Optimal size of OPA
timeFrame: 1 min after each FOB measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Wyun Kon Park, Yonsei University College of Medicine, Department of Anesthesiology and Pain Medicine
Study officials:
References:
Clinical trial NCT05341362: Hemodynamic Management in Women With SHS
Official title: Hemodynamic Management Target on Continuous Monitoring in Cesarean Delivery-A Randomized Controlled Trial in Patients With Supine Hypotensive Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Supine Hypotensive Syndrome
Keywords: supine hypotensive syndrome
cesarean delivery
spinal anesthesia
CSEA
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Supine hypotensive syndrome often occurs following spinal anesthesia for cesarean delivery.In our study we base the regulation and drug administration both on the regular monitor and on a novel monitor which reflects upon the hemodynamic changes. Our aim is to observe whether the outcome of SHS patients with anesthesia management based on hemodynamic figures differs from those based on experience.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Physical Status Classification II and had no significant cardiovascular, pulmonary, renal or endocrine disease, without contraindications to CSEA,and could be diagnosed as SHS according to the criteria.

Exclusion Criteria:

* Patients undergoing emergency CD, CD under general anesthesia or patients' refusal to participate, or multiple fetations.

Primary outcomes:
measure: Umbilical arterial blood gas PH
timeFrame: 30minutes
Secondary outcomes:
measure: Discomfort Score
timeFrame: 1day
measure: total vasopressor dosage
timeFrame: 30 minutes
measure: Umbilical blood gas lactate
timeFrame: 30minutes
measure: Time span
timeFrame: 2 hours
Other outcomes:
Locations:
city: Shenyang
country: China
facility: China Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT02203162: Effect of Electronic Cigarette Use on Cough Reflex Sensitivity
Official title: Effect of Electronic Cigarette Use on Cough Reflex Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cough
Keywords: cough
cough reflex sensitivity
electronic cigarette
capsaicin
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Although electronic cigarettes (e-cigs) are now widely used, very little information exists regarding the effect of electronic cigarette use (vaping) on the respiratory system. The aim of this study is to evaluate the acute effect of one e-cig vaping session (30 puffs 30 seconds apart) on cough reflex sensitivity in healthy adult nonsmokers.

Detailed description: 30 adult nonsmokers will have their cough reflex sensitivity measured at baseline, 15 minutes after an e-cig vaping session, and 24 hours subsequently. One e-cig vaping session will consist of 30 puffs of an e-cg (Blu) 30 seconds apart, which will deliver the approximate nicotine amount delivered by one tobacco cigarette. Cough reflex sensitivity, defined as C5, the concentration of capsaicin inducing 5 or more coughs, is the standard end point of cough challenge studies.

Eligibility criteria: Inclusion Criteria:

* healthy adults (age18 years and above)
* nonsmokers

Exclusion Criteria:

* previous smoker
* asthma/other respiratory illness
* acute viral upper respiratory tract infection (common cold) in previous 4 weeks

Primary outcomes:
measure: Change in Cough Reflex Sensitivity (Log C5)
timeFrame: Baseline, 15 minutes, and 24 hours post-exposure to e-cig.
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Einstein Division/Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center and Albert Einstein College of Medicine
name: Peter V Dicpinigaitis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dicpinigaitis PV, Lee Chang A, Dicpinigaitis AJ, Negassa A. Effect of e-Cigarette Use on Cough Reflex Sensitivity. Chest. 2016 Jan;149(1):161-5. doi: 10.1378/chest.15-0817. Epub 2016 Jan 6.
Clinical trial NCT05090462: PICO Dressings for Emergency Laparotomy
Official title: The Use of PICO Dressings for Patients Undergoing Emergency Laparotomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Site Infection
Lead sponsor: North Middlesex University Hospital NHS Trust
Sponsor class: OTHER_GOV
First posted: 2021-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients (\>/= 18 years) undergoing emergency (laparotomy) surgery at a single centre (North Middlesex University Hospital, London, UK) will be included.

Brief summary: SSI (Surgical Site Infection) rate is an important consideration after emergency laparotomy. SSIs carry a high financial burden for health institutes with the cost of major SSIs after emergency laparotomy to add an additional cost of £10000-£15000 per patient.

NICE has recommended the use of PICO dressings for the reduction of SSI rate as a cost-neutral.

The purpose of this study was to review the current SSI rate, assess the patient risk factors for development of SSIs and evaluate if the use of PICO dressings as per NICE guidelines will reduce the SSI rate.


Eligibility criteria: Inclusion Criteria:

* All emergency midline laparotomy
* Laparoscopic converted open

Exclusion Criteria:

- Reoperation with 28 days of index laparotomy

Primary outcomes:
measure: SSI Day 7
timeFrame: Day 7
Secondary outcomes:
measure: SSI Day 7
timeFrame: Day 28
measure: Length of stay
timeFrame: through study completion, an average of 6 months
measure: Surgical site complications
timeFrame: Day 28
measure: Reoperation
timeFrame: Day 28
measure: SSI grading
timeFrame: Day 28
measure: Length of antibiotic therapy
timeFrame: Day 28
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Nader University Bedwani
Study officials:
References:
Clinical trial NCT01707862: Surgery for Intravenous Leiomyomatosis
Official title: Surgical Management of Intravenous Leiomyomatosis With Intracardiac Extension: Our Experience and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leiomyomatosis
Keywords: Intravenous leiomyomatosis
Surgery
Smooth muscle tumor
Lead sponsor: General Hospital of Beijing PLA Military Region
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From March 1997 to June 2011, 6 women patients were admitted to our hospital with intravenous leiomyomatosis with intracardiac extension.

Brief summary: Intravenous leiomyomatosis (IVL) with intracardiac extension is a rare benign smooth muscle tumor. Reviewing literature, intracardiac extension of the IVL has been reported in at least 70 cases. Most are individual case reports. Surgical experience is not much. However, different opinion of surgical strategies remain controversial. The purpose of this report is to describe our experience of surgical management for the IVL with intracardiac extension.

Detailed description: All patients underwent surgical management. Clinical data were obtained from medical reports. Following-up was made through email and telephone.

Eligibility criteria: Inclusion Criteria:

* Age more than 18 years.
* Tumor markers were all within normal limits.
* Patients underwent surgical management.
* Patients were followed-up for more than 12 months.

Exclusion Criteria:

-Tumor markers were all within abnormal limits

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Cardiovascular Disease
Study officials:
affiliation: Institute of Cardiovascular Disease
name: Genetal Hospital Beijing Military Region, First class
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05649462: Effect of Vitamin D Supplementation on Vedolizumab Response in Patients With Ulcerative Colitis
Official title: Retrospective Analysis of the Effect of Vitamin D Supplementation on the Clinical Efficacy of Vedelizumab in Ulcerative Colitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Vitamin D Deficiency
Vitamin D Supplement
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese

Brief summary: It is uncertain whether vitD3 supplementation is beneficial for the remission of ulcerative colitis (UC). The effects of vitD3 supplements on the efficacy of vidrecizumab in Chinese UC patients were retrospectively analyzed. Methods: Patients with moderate to severe UC were recorded. These patients were initially treated with VDZ. VitD3 supplementation was defined as 400IU/d vitD3 supplementation during the first infusion of VDZ and continued throughout the follow-up period. Disease activity was assessed using the modified Mayo score.


Eligibility criteria: Inclusion Criteria:

* moderate-to-severe UC
* Treated with Vedolizumab

Exclusion Criteria:

* had recent supplementation of vitD3
* pregnant
* had cognitive/developmental disorders that affected their ability to complete the study procedures
* had medical illness or therapies potentially affecting bone, nutrition or growth status
* unknown or untested baseline serum 25(OH)D level

Primary outcomes:
measure: Serum 25 (OH) D level
timeFrame: 30 weeks
measure: disease activity
timeFrame: 30 weeks
Secondary outcomes:
measure: drug survival
timeFrame: 54 week
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: SAHWenzhouMU
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Xia shenglong, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03938662: S-adenosylmethionine Plus Choline in Treatment of Patients With Alcoholic Liver Disease
Official title: Randomised Controlled Trial Assessing the Effect of S-adenosylmethionine Plus Choline in Treatment of Patients With Alcoholic Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcoholic Liver Diseases
Keywords: alcoholic liver diseases
S-Adenosyl methionine
choline
Lead sponsor: University Clinic Dr Dragisa Misovic-Dedinje
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will assess the effect of treatment with formulation containing S-Adenosyl methionine and choline, on patients with alcoholic liver disease.

Half of the patients included will receive named formulation once daily for 24 weeks while other half will receive placebo.

Detailed description: Choline and S-Adenosyl methionine are nutrients both showing hepatoprotective effects.

Choline helps liver metabolise glucose and lipids and repair cell membrane. S-Adenosyl methionine is essential for the synthesis of glutathione, a main cellular antioxidant showing its protective effect against free radicals, among others in liver tissue. Furthermore S-Adenosyl methionine is involved in regulation of hepatocyte growth, differentiation, and death. It also enables endogenous production of small amount of choline. Although human organism has capacity for production of small amount of S-Adenosyl methionine, damaged liver can not produce it or produce it insufficient amounts.

Having this in mind it can be hypothesised that administration of choline and S-Adenosyl methionine can be beneficial in patients with alcoholic liver disease.

Eligibility criteria: Inclusion Criteria:

* alcoholic liver disease

Exclusion Criteria:

* hepatitis B
* hepatitis C
* autoimmune hepatitis
* hemochromatosis
* Wilson's disease
* hepatocellular carcinoma

Primary outcomes:
measure: Alanine aminotransferase (ALT)
timeFrame: 24 weeks
Secondary outcomes:
measure: Aspartate aminotransferase (AST)
timeFrame: 24 weeks
measure: Gamma-glutamyl transferase (GGT)
timeFrame: 24 weeks
measure: Alkaline phosphatase (ALP)
timeFrame: 24 weeks
measure: Serum bilirubin
timeFrame: 24 weeks
Other outcomes:
measure: Serum proteins
timeFrame: 24 week
measure: Serum albumins
timeFrame: 24 week
measure: Serum cholesterol
timeFrame: 24 week
measure: Serum triglycerides
timeFrame: 24 week
Locations:
city: Belgrade
country: Serbia
facility: University Clinic Dr Dragisa Misovic-Dedinje
Study officials:
References: