louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03863938: Food-Effect on PK and PD of Single Oral Dose of Tegoprazan in Healthy Male Subjects
Official title: A Randomized, Open-label, Single-dose Phase 1 Clinical Trial to Compare the Effect of Timing of Food on the Pharmacokinetics and Pharmacodynamics of K-CAB (Tegoprazan) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2019-03-05
Enrollment: 12
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the food-effect of tegoprazan 50mg on the pharmacokinetics and pharmacodynamics in healthy H. pylori negative male volunteers

Detailed description: Primary Outcome Measure:

1. AUClast and Cmax of tegaprazan
2. Gastric pH

Eligibility criteria: Inclusion Criteria:

* Healthy adult males aged ≥ 19 years and ≤ 50 years
* Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening
* Helicobacter pylori negative

Exclusion Criteria:

* Presence or history of clinically significant diseases
* Presence or history of gastrointestinal disorder (gastric ulcer, GERD, Crohn's disease, etc.)
* Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
* Serologic test positive
* Abnormal obstacle to insertion and maintenance of pH meter catheter
* History of drug abuse
* Excessive caffeine intake or persistent alcohol intake
* Not use of a medically acceptable method of contraception

Primary outcomes:
measure: AUClast of tegaprazan
timeFrame: Pre-dose(0 hour) and up to 48 hours in each period
measure: Cmax of tegaprazan
timeFrame: Pre-dose(0 hour) and up to 48 hours in each period
measure: Gastric pH
timeFrame: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Clinical Trial Center
Study officials:
affiliation: Seoul National University Hospital, Dept. of Clinical Pharmacology
name: In-Jin Jang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01239238: Reduction of Asthma Exacerbation Rate in Children by Non-invasive Monitoring of Inflammatory Markers in Exhaled Breath (Condensate): the RASTER Study
Official title: Reduction of Asthma Exacerbation Rate in Children by Non-invasive Monitoring of Inflammatory Markers in Exhaled Breath (Condensate): the RASTER Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Children
Home Monitoring
Exhaled Breath Condensate
Non-invasive Inflammatory Markers
Volatile Organic Compounds
Keywords: asthma
children
home monitoring
exhaled breath condensate
non-invasive inflammatory markers
volatile organic compounds
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2010-11-11
Enrollment: 102
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study is carried out in two hospitals in the Netherlands (Maastricht University Medical Centre, Maastricht; and Orbis Medical Centre, Sittard).

Brief summary: The purpose of the present proposal was to investigate the predictive properties of markers in exhaled breath to predict an asthma exacerbation. In addition, the reliability of home monitor assessments to measure asthma control will be examined.


Eligibility criteria: Inclusion Criteria:

1. already known with a diagnosis of asthma during at least 6 months
2. age between 6 and 17 years
3. reversibility to a bronchodilator (increase in FEV1 \> 9% of predicted value and/or
4. bronchial hyperresponsiveness to histamine \< 8 mg/ml.

Exclusion Criteria:

1. cardiac abnormalities
2. mental retardation, congenital abnormalities or existence of a syndrome
3. active smoking
4. no technical satisfactory performance of measurements
5. no phone line or internet assess available at home.

Primary outcomes:
measure: number of exacerbations
timeFrame: 1 year
measure: asthma control
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
Secondary outcomes:
measure: cost-effectiveness
timeFrame: 1 year
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
city: Sittard
country: Netherlands
facility: Orbis Medical Centre
Study officials:
affiliation: Maastricht UMC
name: Edward Dompeling, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Vliet D, van Horck M, van de Kant K, Vaassen S, Gulikers S, Winkens B, Rosias P, Heynens J, Muris J, Essers B, Jobsis Q, Dompeling E. Electronic monitoring of symptoms and lung function to assess asthma control in children. Ann Allergy Asthma Immunol. 2014 Sep;113(3):257-262.e1. doi: 10.1016/j.anai.2014.05.015. Epub 2014 Jun 18.
Clinical trial NCT02329938: Desarda Repair for Inguinal Hernia
Official title: Desarda Versus Lichtenstein's Repair for Inguinal Hernia: a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Unlike Lichtenstein tension free repair for inguinal hernia, Desarda's repair was introduced as a pure tissue repair with no need for mesh. In other words; the complications which may arise from the use of a foreign body (mesh) will be avoided. The idea was to evaluate the efficacy of this new repair and compare it to the standard Lichtenstein repair.


Eligibility criteria: Inclusion Criteria:

* inguinal hernia

Exclusion Criteria:

* recurrent inguinal hernia
* giant inguinal hernia
* mental disorder
* refusal to participate

Primary outcomes:
measure: number of patients with recurrence of inguinal hernia
timeFrame: 2 years
Secondary outcomes:
measure: VAS score for pain
timeFrame: one year
measure: number of patients develped postoperative complications
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
citation: Youssef T, El-Alfy K, Farid M. Randomized clinical trial of Desarda versus Lichtenstein repair for treatment of primary inguinal hernia. Int J Surg. 2015 Aug;20:28-34. doi: 10.1016/j.ijsu.2015.05.055. Epub 2015 Jun 11.
Clinical trial NCT03806972: Short and Long Term Prognosis of Patients Admitted to the ED With Acute Heart Failure
Official title: Short and Long Term Prognosis of Patients Admitted to the Emergency Department With Acute Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Heart Failure
Keywords: acute heart failure prognosis
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study included all patients ,with either reduced ejection fraction (HFrEF) defined as LVEF \<45% or preserved ejection fraction (HFpEF) defined as LVEF ≥45% ,admitted to the ED of Monastir between 2009-2020 with a principal discharge diagnosis code for HF. The diagnosis of HF categories should rely on the recent transthoracic echocardiographic findings and clinical judgement according to the guidelines.Collected data include clinical features biological markers (BNP or NTpro BNP) and echocardiography findings. The diagnosis of HF categories should rely on the recent transthoracic echocardiographic findings and clinical judgement according to the guidelines. A follow-up period of at least 1 year was required to notice all cause mortality and preferably HF-specific rehospitalization .

Brief summary: Heart failure (HF) is the leading cause of hospitalization ,rehospitalization and mortality for adults over 65 years of age.

This study aimed to assess mortality, and hospitalization rates at 30 days and one year after dicharge of patients with heart failure (HF) with reduced ejection fraction (HFrEF) compared to HF with preserved ejection fraction (HFpEF).


Eligibility criteria: Inclusion Criteria:

* patients admitted to the ED of Monastir with a principal discharge diagnosis code for HF.

Exclusion Criteria:

* Pregnant or breast feeding women. Alteration of consciousness GCS \< 15 Critically ill patients needing immediate mechanical hemodynamic of ventilatory support.

Inability to follow instructions or comply with follow-up procedures.

Primary outcomes:
measure: Death or readmission rates
timeFrame: within 365 days after hospital discharge
Secondary outcomes:
measure: Death or readmission rates
timeFrame: within 30 days after hospital discharge
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Emergency Departement
Study officials:
affiliation: university Hospital of Monastir
name: Nouira Semir, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castello LM, Molinari L, Renghi A, Peruzzi E, Capponi A, Avanzi GC, Pirisi M. Acute decompensated heart failure in the emergency department: Identification of early predictors of outcome. Medicine (Baltimore). 2017 Jul;96(27):e7401. doi: 10.1097/MD.0000000000007401.
citation: Searle J, Frick J, Mockel M. Acute heart failure facts and numbers: acute heart failure populations. ESC Heart Fail. 2016 Jun;3(2):65-70. doi: 10.1002/ehf2.12092. Epub 2016 Apr 25.
Clinical trial NCT01984372: Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Tresiba®
Official title: A Multi-centre, Open Label, Observational, Non-interventional, Post Marketing Surveillance to Evaluate Safety and Effectiveness During Long-term Treatment With Tresiba® (Insulin Degludec) in Patients With Diabetes Mellitus Requiring Insulin Therapy Under Normal Clinical Practice Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-11-14
Enrollment: 6163
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetes mellitus requiring insulin therapy not previously treated with Tresiba®, including newly-diagnosed patients whom the physician has judged as appropriate to start treatment with Tresiba®.

Brief summary: This study is conducted in Asia. The aim of this post marketing surveillance (PMS) is to assess safety and effectiveness of long-term treatment with Tresiba® (insulin degludec) in patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.

A total of 4000 patients will be enrolled to investigate long term (3 years of treatment) safety of Tresiba® and additional 2000 patients will be enrolled to assess the safety in an early stage of the PMS more precisely. At the time of enrolment the patients will be randomly allocated to either 3 years or 6 months observation group.


Eligibility criteria: Inclusion Criteria:

* Patients with diabetes mellitus requiring insulin therapy for whom the treating physician has decided to start Tresiba® treatment

Exclusion Criteria:

* Patients who are or have previously been on Tresiba® therapy
* Patients who have previously been participating in this PMS

Primary outcomes:
measure: Incidence of AEs (Adverse Events) by preferred term
timeFrame: During 3 years of treatment
Secondary outcomes:
measure: Incidence of AEs (Adverse Events) by preferred term
timeFrame: During 6 months of treatment
measure: Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term
timeFrame: During 6 months of treatment
measure: Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term
timeFrame: During 3 years of treatment
measure: Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term
timeFrame: During 6 months of treatment
measure: Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term
timeFrame: During 3 years of treatment
measure: Incidence of severe hypoglycaemia
timeFrame: During 6 months of treatment
measure: Incidence of severe hypoglycaemia
timeFrame: During 3 years of treatment
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03756272: Stellate Ganglion Block to Reduce Hot Flushes
Official title: Short-term Efficacy of Stellate Ganglion Block to Reduce Hot Flushes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flash
Stellate Ganglion Block
Postmenopausal
Hot Flushes
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 76
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure

Detailed description: Hot flushes are the most common symptom of menopause for which postmenopausal (PMP) women seek medical help, in 20% of PMP women hot flushes can persist for up to 15 years.

A possible treatment for hot flushes is stellate ganglion block (SGB), used as a means to interrupt parts of the sympathetic nervous system involved in temperature regulation.

Single centre randomized double blind placebo controlled intervention study Study period of 6 months in which patients will fill out on set time points 5 questionnaires regarding quality of life and keep a diary on hot flush frequency and severity during1 week on the same time points.

Study population:

Postmenopausal women aged 30-70 years old with no other causes of flushing present. Intervention (if applicable) Intervention: Stellate ganglion block versus sham procedure

Follow up with questionnaires during 6 months.

Eligibility criteria: Inclusion Criteria:

* Female
* Age: 30-70 years
* Mean daily flush frequency of 10 or more and a hot flush score of 15 or more
* Absence of any non-menopausal cause of flushing
* Post-menopause amenorrhea for more than 1 year in healthy postmenopausal women
* In case of breast cancer or ovariectomy induced menopause: ovariectomy for \> 6 months. Adjuvant therapy with estrogen-receptor blocker or an aromatase inhibitor.

Exclusion Criteria:

* Use of medication that affects flushing:oestrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlafaxine, gabapentin, luteïniserend hormone releasing hormones receptor antagonist
* Receiving chemotherapy of radiotherapy
* Active psychiatric disease
* Active concurrent disease
* Allergic reactions against local anesthetics of the 'amide' type or contrast media.

Primary outcomes:
measure: Hot Flush score
timeFrame: Baseline, 4, and 8 weeks
Secondary outcomes:
measure: Quality of sleep
timeFrame: Baseline, 4, and 8 weeks
measure: Sleepiness
timeFrame: Baseline, 4, and 8 weeks
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate hospital
Study officials:
affiliation: Rijnstate Hospital
name: Jan Willem Kallewaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00931372: Lixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2
Official title: Restoration of First Phase Insulin Release in Subjects With Type 2 Diabetes Mellitus With Subcutaneous Injection of 20 µg AVE0010 in a Double-blind, Randomized, Placebo-controlled, Two-way Cross Over Intravenous Glucose Challenge Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Insulin release
Diabetes mellitus type 2
GLP-1 agonist
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Profil GmbH, Neuss, Germany
First posted: 2009-07-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to test whether Lixisenatide (AVE0010) restores first phase and improves second phase insulin response in subjects with diabetes mellitus type 2.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects with type 2 diabetes mellitus on diet and exercise with/without metformin
* HbA1c\>=6,0 % and \<=8,5 % at screening
* BMI 25 to 35 kg/m²
* 155\>=BP systolic \>=90 mmHg
* 100\>=BP diastolic\>=45 mmHg

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Area under the insulin secretion curve
timeFrame: within 10 minutes after I.V. glucose challenge
Secondary outcomes:
measure: Area under the insulin secretion curve
timeFrame: within 10 to 120 minutes after I.V. glucose challenge
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Profil GmbH, Neuss, Germany
name: Christoph KAPITZA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06284772: FINRISK 2002 Re-examination
Official title: FINRISK 2002 Re-examination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiometabolic Syndrome
Cardiovascular Diseases
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Finnish Institute for Health and Welfare
First posted: 2024-02-29
Enrollment: 2500
Sex: ALL
Minimum age (years): 47
Maximum age (years): 96
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The FINRISK 2002 cohort (N=7,237 participants with sequenced fecal samples) was originally examined in 2002. The FINRISK 2002 cohort is a random sample of the Finnish population, aged 25-74 years in the year 2002, from 6 geographic regions in Finland.

Brief summary: The project aims to fill in the existing gaps in the study of the microbiome as a cardiometabolic driver 1) by determining the key demographic, environmental, genetic, dietary, and metabolic correlates of long-term within-individual microbiome and microbial metabolite changes; and 2) by assessing how the gut microbiome, microbial metabolites, and their long-term changes are prospectively related to the risk factors, surrogate markers, and overt outcomes of CMD. To achieve this goal, repeat stool samples will be collected of \~2300 Finnish individuals who gave stool samples in the year 2002. In addition, \~300 individuals will undergo a in-depth health examination in 2024.


Eligibility criteria: Inclusion Criteria:

* Participation in FINRISK 2002 fecal sampling

Primary outcomes:
measure: Gut microbiome change between 2002-2024
timeFrame: 2002-2024
Secondary outcomes:
measure: Correlates of gut microbiome change between 2002-2024
timeFrame: 2002-2024
Other outcomes:
Locations:
city: Turku
country: Finland
facility: University of Turku
Study officials:
affiliation: Department of Internal Medicine, University of Turku
name: Teemu Niiranen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borodulin K, Tolonen H, Jousilahti P, Jula A, Juolevi A, Koskinen S, Kuulasmaa K, Laatikainen T, Mannisto S, Peltonen M, Perola M, Puska P, Salomaa V, Sundvall J, Virtanen SM, Vartiainen E. Cohort Profile: The National FINRISK Study. Int J Epidemiol. 2018 Jun 1;47(3):696-696i. doi: 10.1093/ije/dyx239. No abstract available.
citation: Salosensaari A, Laitinen V, Havulinna AS, Meric G, Cheng S, Perola M, Valsta L, Alfthan G, Inouye M, Watrous JD, Long T, Salido RA, Sanders K, Brennan C, Humphrey GC, Sanders JG, Jain M, Jousilahti P, Salomaa V, Knight R, Lahti L, Niiranen T. Taxonomic signatures of cause-specific mortality risk in human gut microbiome. Nat Commun. 2021 May 11;12(1):2671. doi: 10.1038/s41467-021-22962-y.
Clinical trial NCT05177172: Effect of Oat Compounds on Postprandial Glucose Response
Official title: Synergistic Effect of Oat Beta-glucans and Oat Polar Lipids on Postprandial Glucose Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: Prevention
food
diabetes type 2
postprandial glucose regulation
appetite
oat
polar lipids
obesity
glucose tolerance
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised food study in healthy subjects
Primary purpose: PREVENTION

Brief summary: In this project we will investigate synergistic effects of oat polar lipids and beta glucans on postprandial glucose tolerance


Eligibility criteria: Inclusion Criteria:

* healthy
* BMI 20-28 kg/m2
* Diet which follows the Nordic Nutrition Recommendations (non-vegetarian)

Exclusion Criteria:

* fasting glucose \> 6.1 mmol/L
* metabolic diseases
* gastrointestinal disease
* chronic and/or psychological disease
* food allergy
* Vegetarian or vegan diets, or other special diets

Primary outcomes:
measure: Glucose tolerance
timeFrame: 3 hours. Fasting (time =0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Secondary outcomes:
measure: Subjective appetite variables
timeFrame: 3 hours. Fasting (time =0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University, Food Technology, Engineering and Nutrition
Study officials:
References: