louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02278380: Different Glycemic Index (GI) Values in 7 Food Products
Official title: In-Vivo Glycemic Index (GI) and Insulinemic Index (II) Testing of 7 Test Foods in Total (5 Milk-based Beverage and 2 Standard Breakfast Items)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Index
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
First posted: 2014-10-30
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study is initiated to investigate the glycemic index value of seven food products.


Eligibility criteria: Inclusion Criteria:

* Healthy males or non-pregnant females at least 6 weeks postpartum, non-lactating and aged 21-60yrs old in both groups.
* They should not suffer from any chronic diseases.
* no known food allergy or intolerance.
* no medications known to affect glucose tolerance(excluding oral contraceptives). Note: stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.

Exclusion Criteria:

* Age less than 21 years old and greater than 60 years old.
* known history of diabetes mellitus or the use of antihyperglycemic drugs or insulin to treat diabetes and related conditions.
* known history of AIDS, hepatitis, renal or heart disease or any other serious complications that may interfere with glucose metabolism.
* subjects using any medication (eg steroids, protease inhibitors or antipsychotics, etc.) that would interfere with the digestion and nutrient absorption.,
* subjects having gastrointestinal diseases that may interfere with nutrient absorption, distribution, metabolism, excretion and have no known food allergies.
* a major medical or surgical event requiring hospitalisation within the preceding 3 months.

Primary outcomes:
measure: Glycemic index values of all seven products
timeFrame: 120 minutes post administration
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Temasek Polytechnic
Study officials:
affiliation: Temasek Polytechnic
name: Kalpana Bhaskaran, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00740480: Study of the ENTact Septal Staple System for Tissue Approximation During Septoplasty
Official title: A Prospective, Non-Randomized, Limited-Use Evaluation of the ENTact Septal Staple System for Tissue Approximation During Septoplasties
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasal Septum
Keywords: Evaluation
ENTact™
Septal
Staple
System
tissue
approximation
during
septoplasties
Lead sponsor: ENTrigue Surgical, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (ages 18-65) with clinically significant nasal septum deviation.

Brief summary: The purpose of this research study is to learn more about the ENTact™ Septal Staple System device performance and to collect information to support its premarket application.

Detailed description: The ENTact™ Staple System is a device that inserts a small staple or tack to hold mucosa (moist tissues) in place instead of using stitches. The staple gradually dissolves and does not need to be removed. This clinical study will evaluate:

* surgical performance of the ENTact Septal Staple System
* one week post op clinical evaluation of gross tissue appearance at implantation site(s)
* ENTact™ Septal Staple functionality based on maintained coaptation

Eligibility criteria: Inclusion Criteria:

* Adult patients, between the ages of 18 and 65 years, with a clinically significant deviation of the nasal septum
* Patient is able to provide a signed informed consent form
* Patient will agree to comply with all study related procedures
* Patient is not pregnant at this time. If patient is of child-bearing age and capable of bearing children, a pre-operative pregnancy test confirmation is required to show that patient is not pregnant on the day of surgery
* Patient does not plan on becoming pregnant and is not breast feeding during the course of the study

Exclusion Criteria:

* Patients who do not meet the inclusion criteria
* Patients who have had previous septoplasty
* Patients with uncontrolled diabetes
* Presence of infection at the site
* Smokers and severe drug and alcohol abusers
* Patients with autoimmune disease deemed clinically significant by Principal Investigator

Primary outcomes:
measure: Coaptation (Tissue Approximation)
timeFrame: One week post surgery
Secondary outcomes:
measure: Tissue Reaction to Implant
timeFrame: One week post surgery
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Bryan
country: United States
facility: Park Hudson Surgery Center
state: Texas
city: San Antonio
country: United States
facility: Physician's Ambulatory Surgery Center IV
state: Texas
Study officials:
affiliation: ENTrigue Surgical, Inc.
name: Gabriele G Niederauer, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01277380: Analysis of the Results From Influenza Rapid Test A Positive and H1N1 Real Time RT-PCR
Official title: Analysis of the Results From Influenza Rapid Test A Positive and H1N1 Real Time RT-PCR
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: H1N1 Influenza Virus
Keywords: H1N1 Influenza virus
swine flu
Real Time RT-PCR
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-01-14
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: H1N1 Influenza

Brief summary: The first outbreak of a new H1N1 influenza pandemic originated in the North America in April 2009. As of July 1, 2009, a total of 77,201 cases were accumulated in 103 countries around the world and the mortality rate of was about 0.43%. Alignment and analysis on gene sequences of the new H1N1 influenza virus found that it contains extremely homologous gene composition with that of the swine influenza viruses (swine flu) identified in Europe and North America in last century. Thus the virus strain was later renamed as a novel influenza H1N1. In general, the symptoms caused by the new influenza H1N1 infection was very similar to those resulted from seasonal influenza viral infection. Thus, it is difficult to distinguish the various influenza strains responsible for the infections only by clinical appearance. To compare the accuracy, specificity and sensitivity and speed in identifying the new influenza H1N1 in suspected cases, the investigators extracted RNA from influenza A-positive reactive specimens identified by a Influenza Rapid Test, for a Real-time PCR method to further detect the presence of swine H1 gene. In addition, the titer of H1N1 virus, the color development on the test stripe and clinical symptoms in patients were significantly associated. Finally, Real-time PCR products were subjected to sequence determination to explore potential new influenza pathogenicity, transmissibility and drug usage.


Eligibility criteria: Inclusion Criteria:

* Influenza Rapid Test Influenza A(+) B(-)
* Influenza Rapid Test Influenza A(+) B(+)
* Influenza Rapid Test Influenza A(-) B(-) was negative control

Exclusion Criteria:

* Influenza Rapid Test Influenza A(-) B(+)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Giueng-Chueng Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04113980: Effects of Distraction Methods on Pain Perceptions and Anxiety Levels in Children During the Blood Collection
Official title: Effects of Distraction Methods on Pain Perceptions and Anxiety Levels in Children During the Blood Collection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Nursing Caries
Keywords: acute pain
anxiety
children
blood collection
nursing
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 134
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aim:This study was conducted to investigate the effects of music, kaleidoscope and video watching methods on children's pain perception and anxiety level during the blood collection procedures.

Methods: This randomized controlled experimental study was carried out with 134 children in the 5-10 age group in the pediatric blood collection unit of a Training and Research Hospital between August and November 2018. In the study, nonpharmacological methods were applied to the children in the experimental groups (Music Group (n=33), Kaleidoscope Group (n=36), Video Group (n=31). The routine blood collection procedure was used for the children in the control group (n=34). The data were collected using the "Introductory Information Form", "Children's Fear and Anxiety Scale (CFAS)", and the "Wong-Baker Faces Pain Rating Scale (WB-FPRS)".


Eligibility criteria: Inclusion Criteria:

* being healthy
* ability to express himself/herself verbally
* no analgesic taken in the last 6 hours
* having no visual or auditory problems

Exclusion Criteria:

* chronic disease
* mental disease
* neurological disease

Primary outcomes:
measure: Children Fear Scale
timeFrame: 1 minute
measure: Wong Baker Face Pain Scale
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Adiyaman
country: Turkey
facility: Adiyaman University
Study officials:
References:
Clinical trial NCT01356680: HD17 for Intermediate Stage Hodgkin Lymphoma
Official title: HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hodgkin Lymphoma
Keywords: Hodgkin Lymphoma
intermediate stage
PET
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2011-05-19
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (PFS).


Eligibility criteria: Inclusion Criteria:

* Hodgkin Lymphoma
* CS I, II with risk factor (stage IIB with risk factor 1 or 2 are not included)
* large mediastinal mass (\>1/3 of maximum transverse thorax diameter)
* extranodal involvement
* elevated ESR
* 3 or more involved nodal areas
* written informed consent

Exclusion Criteria:

* Leucocytes \<3000/µl
* Platelets \< 100000/µl
* Hodgkin Lymphoma as composite lymphoma
* Activity Index (WHO) \>2

Primary outcomes:
measure: Progression Free Survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 years
measure: CR rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: 1st Dept. of Medicine, Cologne University Hospital
Study officials:
affiliation: University of Cologne, German Hodgkin Study Group
name: Andreas Engert, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borchmann P, Plutschow A, Kobe C, Greil R, Meissner J, Topp MS, Ostermann H, Dierlamm J, Mohm J, Thiemer J, Sokler M, Kerkhoff A, Ahlborn M, Halbsguth TV, Martin S, Keller U, Balabanov S, Pabst T, Vogelhuber M, Huttmann A, Wilhelm M, Zijlstra JM, Moccia A, Kuhnert G, Brockelmann PJ, von Tresckow B, Fuchs M, Klimm B, Rosenwald A, Eich H, Baues C, Marnitz S, Hallek M, Diehl V, Dietlein M, Engert A. PET-guided omission of radiotherapy in early-stage unfavourable Hodgkin lymphoma (GHSG HD17): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):223-234. doi: 10.1016/S1470-2045(20)30601-X.
citation: Voltin CA, Goergen H, Baues C, Fuchs M, Mettler J, Kreissl S, Oertl J, Klaeser B, Moccia A, Drzezga A, Engert A, Borchmann P, Dietlein M, Kobe C. Value of bone marrow biopsy in Hodgkin lymphoma patients staged by FDG PET: results from the German Hodgkin Study Group trials HD16, HD17, and HD18. Ann Oncol. 2018 Sep 1;29(9):1926-1931. doi: 10.1093/annonc/mdy250.
Clinical trial NCT03757780: Low Birth Weight Fetuses With Caffeine Use
Official title: Association of Low Birth Weight Fetuses With Caffeine Use
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low; Birthweight, Extremely (999 Grams or Less)
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
First posted: 2018-11-29
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Age group: 18-40

•Pregnant females attending regular post-natal care visits

Brief summary: Globally, it has been estimated that 15.5% of all infantsare born low birth weight, defined as birthweight less than 2,500 g .

Detailed description: Low birth weight is not only associated with neonatal mortality and morbidity.

but also with a higher risk of chronic diseases such as type 2 diabetes and cardiovascular diseases in adult life

Eligibility criteria: Inclusion Criteria:

* Age group: 18-40
* Pregnant females attending regular post-natal care visits

Exclusion Criteria:

* • Female patients with other acute or chronic illness

  * Cardiovascular disease
  * Neoplasms
  * Current diabetes mellitus, pregnancy induced diabetes
  * Renal impairment (serum creatinine 120 mol/liter), and hypertension (blood pressure 140/85 mm Hg).

Primary outcomes:
measure: The number of pregnant ladies who will have low birth weight babies
timeFrame: within 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah and Kasralainy hospital
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy
role: STUDY_CHAIR
References:
Clinical trial NCT02208180: Heart Healthy Lenoir: Return of Results Study
Official title: Heart Healthy Lenoir: Return of Results Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Return of results
Genomics
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-08-04
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators are conducting a two group intervention to study to the effect of individualized heart disease genomic risk results on motivation towards diet and physical activity behaviors to reduce heart disease risk. The intervention includes provided participants with genomic and lifestyle risk estimates. Investigators will follow participants for 3 months to determine if motivation towards and engagement in diet and physical activity behaviors change.


Eligibility criteria: Inclusion Criteria:

* Enrolled in Heart Healthy Lenoir Genomics
* African-American (self-identified)
* Wants to be contacted for future studies

Exclusion Criteria:

* Enrolled in an arm of the Heart Healthy Lenoir Lifestyle study with intense behavioral intervention (e.g. weight loss or weight maintenance programs)

Primary outcomes:
measure: Change in motivation
timeFrame: Baseline, Post-interview, 3 months
Secondary outcomes:
measure: Change in Eating Habits
timeFrame: Baseline, 3 months
measure: Change in Physical Activity
timeFrame: Baseline, 3 months
Other outcomes:
measure: Change in Psychological Adaptation
timeFrame: Baseline, 3 months
Locations:
city: Kinston
country: United States
facility: Heart Healthy Lenoir Field Office
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Harlyn G Skinner, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Alice Ammerman, DrPH, MPH
role: STUDY_CHAIR
References:
Clinical trial NCT06282380: Fibricheck Detection cApabilities for Atrial Fibrillation
Official title: Fibricheck Detection cApabilities for Atrial Fibrillation - a Multicenter Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Qompium NV
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 330
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis.


Eligibility criteria: Inclusion Criteria:

* At least 22 years old;
* Capable of independently performing FibriCheck recordings (researcher-observed);
* Cardiology patients, hospitalized/in-clinic or consulting the cardiac outpatient clinic, with or without a diagnosis of atrial fibrillation.

Exclusion Criteria:

* Individuals with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can influence the natural heart rhythm;
* Individuals enrolled in another clinical trial;
* Individuals with physical or medical characteristics that prevent them from successfully taking a measurement e.g. extreme callus (i.e., rough or thickened area of skin fingertip), tremor, cognitive impairment, Parkinson's disease;
* Pregnant and/or nursing women.

Primary outcomes:
measure: Accuracy of the FibriCheck Mobile Application
timeFrame: Through study completion: 1 day
Secondary outcomes:
measure: Sensitivity of the FibriCheck Mobile Application
timeFrame: Through study completion: 1 day
measure: Specificity of the FibriCheck Mobile Application
timeFrame: Through study completion: 1 day
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicin
state: Illinois
city: New York
country: United States
facility: New York Presebyterian Queens
state: New York
city: Oklahoma City
country: United States
facility: OU Medicine College
state: Oklahoma
city: Antwerpen
country: Belgium
facility: University Hospital Antwerp
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
References:
Clinical trial NCT05991180: Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell Lung Cancer
Official title: Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell Lung Cancer and Assessment of Biomarkers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extensive-stage Small-cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Extensive Stage Small Cell Lung Cancer

Brief summary: This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.


Eligibility criteria: Inclusion Criteria:

* Patients must be ≥18 years.
* Provision of fully informed consent prior to any study specific procedures.
* Patients with extensive stage SCLC diagnosed by pathology (as staged by the American Veterans Lung Cancer Association (VALG)), who do not have an imaging response during first-line treatment with PD-(L)1 inhibitors, or who progress after imaging reactions on first-line therapy (the most recent regimen prior to enrollment must contain PD-(L)1 inhibitors).
* According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.

Exclusion Criteria:

* None

Primary outcomes:
measure: ORR
timeFrame: 2 years
Secondary outcomes:
measure: PFS
timeFrame: 2 years
measure: OS
timeFrame: 2 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer hospital
state: Hunan
Study officials:
References:
Clinical trial NCT01162980: The Angiotensin Converting Enzyme (ACE) Inhibitor SwitchBack Study
Official title: The ACEi SwitchBack Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: ACE inhibitors
ARBs
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Servier
First posted: 2010-07-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: heart failure patients followed in heart failure clinics in Canada

Brief summary: ACE inhibitors have been studied extensively in the treatment of heart failure and have been shown to be beneficial in all its stages. Studies with the use of angiotensin receptor blockers (ARBs) in chronic heart failure have not shown equivalent results. Many patients are on an ARB for a variety of reasons. Some of these may have had cough as a symptom of heart failure and not due to medication side effect. According to guidelines, angiotensin converting enzyme inhibitors (ACEi) are still first-line therapy in the treatment of heart failure. As ACEi have been extensively studied showing improvement in morbidity and mortality all patients should be on this treatment unless absolutely contraindicated.


Eligibility criteria: Inclusion Criteria:

* heart failure patients who have indications for ACEi but are currently on ARBs with no absolute contraindications to ACEi
* patients with an ejection fraction of \< or = 35% verified in the last 12 months by echo, angio, or nuc med who are NYHA class I to IV and followed in a heart failure clinic for three months
* on beta-blockers, unless contra-indicated
* stable on current meds for 3 months (except dose of diuretics)
* able to give informed consent

Exclusion Criteria:

* documented angioedema/anaphylaxis with prior ACEi use
* documented worsening renal failure, hyperkalemia, cough and gastrointestinal symptoms that are definitely believed to be due to ACEi
* potassium \>5.0 mmol/L

Primary outcomes:
measure: proportion of patients on ARB who are switched back to ACEi and\ who tolerate ACEi
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: Royal Victoria Hospital, McGill University Health Centre
name: Nadia Giannetti, MD
role: PRINCIPAL_INVESTIGATOR
References: