louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00700908: Impact of an Automated Telephone Intervention on Glycosylated Hemoglobin (HbA1c) in Type 2 Diabetes
Official title: The Impact of an Automated Telephone Intervention on HbA1c in Type 2 Diabetes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
telephone intervention
automated
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2008-06-19
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim 1. Determine the impact of a daily, automated telephone intervention on HbA1c levels compared to standard care in older patients with type 2 diabetes.

Aim 2. Determine the impact of the automated telephone intervention compared to standard care on adherence to prescribed SMBG frequency in older patients with type 2 diabetes.

Aim 3. Determine the impact of the automated telephone intervention compared to standard care on self-reported diabetic control problems in older patients with type 2 diabetes.

Aim 4. Determine the impact of the automated telephone intervention compared to standard care on self-reported attitudes and health beliefs concerning diabetes in older patients with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* Age greater or equal to 55
* Type 2 diabetes
* English speaking
* Ability to use glucose meter

Exclusion Criteria:

* Unable to give informed consent
* Unwilling to allow SMBG levels to be shard with primary care physician

Primary outcomes:
measure: Change in HbA1c
timeFrame: three months
Secondary outcomes:
measure: Change in adherence to SMBG frequency
timeFrame: three months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Primary Care Center University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Judith Graziano, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07018908: Effect of Intake of Dehydrated Nopal Powder From Highly Mature Cladodes on the Lipid Profile
Official title: Effect of Intake of Dehydrated Nopal Powder From Highly Mature Cladodes (Opuntia Ficus-indica) on the Lipid Profile of Overweight or Obese Adults. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Dyslipidemia
Keywords: Opuntia ficus-indica
dyslipidemia
overweight
obesity
diet
Lead sponsor: Universidad Autónoma de Querétaro
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group I (first arm): 5 g of dehydrated nopal + normocaloric diet. Group II (second arm): 15 g of dehydrated nopal + normocaloric diet. Group III (third arm): normocaloric diet only (control or comparison group).

This design allows for the comparison of the effects of different doses or treatments (in this case, different amounts of nopal) against a control (the diet alone).
Primary purpose: TREATMENT

Brief summary: Background: Opuntia ficus-indica is a plant from the cactus family (Cactaceae) that is widespread and of great economic importance in Mexico. It has been consumed as food since pre-Hispanic times and is currently considered a nutraceutical. In this study, the effect of consumption of dehydrated nopal powder from highly mature cladodes (Opuntia ficus-indica) on the lipid profile of overweight or obese patients diagnosed with dyslipidemia was investigated. Methods: A 3-month prospective clinical trial was conducted in 35 overweight or obese patients with dyslipidemia. The sample was divided into three groups with a daily intake of 30 g of dietary fiber: Group I received 5 g of dehydrated Opuntia ficus-indica cladodes plus the standard normocaloric diet for dyslipidemia, Group II received 15 g plus the diet, and Group III followed only the diet.


Eligibility criteria: Inclusion Criteria:

* Participants with dyslipidemia, confirmed by lipid meas-urement in blood chemistry
* overweight or obesity
* A cardiovascular risk factor associated with abdominal obesity

Exclusion Criteria:

* Patients with a suspected diagnosis of primary dyslipidemia
* Diabetes
* Hypertension
* Thyroid disease were excluded from the study
* Patients with complex or severe disease such as heart failure, liver or kidney disease
* Pregnant or lactating women
* Indidividuals taking lipid-modifying drugs or hormone replacement therapy - Patients with gastrointestinal problems and deficiencies

Primary outcomes:
measure: Blood lipid levels
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Juriquilla
country: Mexico
facility: Autonomous University of Queretaro
state: Queretaro
Study officials:
References:
Clinical trial NCT06894108: The Effectiveness of a Proprietary of a Botanical Extract on Sleep Quality
Official title: The Effectiveness of a Proprietary of a Botanical Extract on Sleep Quality As Compared to a Melatonin Control: a Randomized, Double-Blinded, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Lead sponsor: Nutraceuticals Research Institute
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 88
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the efficacy and superiority of a botanical based sleep product on sleep quality as compared to melatonin, among healthy female participants.


Eligibility criteria: Inclusion Criteria:

Provision of signed and dated informed consent form Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study Self reported poor sleep quality Biological sex of woman; gender identification of female Aged 35 to 55, inclusive Good general health as evidenced by medical history and screening For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study Has an apple watch or similar device Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria:

Pregnancy, trying to conceive, or breastfeeding Currently smokes or vapes (i.e., tobacco, flavored items, marijuana, etc.) or has in the past year Has received medical diagnosis or treatment for any sleep disorder in the past year Has ever received a medical diagnosis of sleep apnea or narcolepsy Works a night shift, is "on-call" or performs any job requiring or potentially requiring work related responsibilities after 8pm Consumes \> 8 alcoholic beverages in an average week Is a primary caretaker for a child younger than 18 months of age Consumes any sleep aid, medication, diet, or supplement intended to improve sleep in any way Known allergic reactions to any components of the intervention Positive COVID-19 test within 30 days of the study period Recent dramatic weight changes (10% change in body weight in the last 6 months) Introducing a new investigational drug or other intervention within 60 days before the start of the study

Primary outcomes:
measure: NRI Sleep Scale
timeFrame: From baseline to the end of the 28 day intervention.
Secondary outcomes:
measure: Wearable Technology
timeFrame: From baseline to the end of the 28 day intervention.
measure: NRI Energy Scale
timeFrame: From baseline to the end of the 28 day intervention.
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Nutraceuticals Research Institute
state: Alabama
Study officials:
References:
Clinical trial NCT06826508: Modes of Delivery Impact Maternal Oxidative Stress Biomarkers and Dynamic Thiol Disulphide Homeostasis
Official title: Modes of Delivery Impact Maternal Oxidative Stress Biomarkers and Dynamic Thiol Disulphide Homeostasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Delivery
Cesarian Section
Oxidative Stress
Lead sponsor: Mardin Artuklu University
Sponsor class: OTHER
Collaborators: name: Alanya Alaaddin Keykubat University
First posted: 2025-02-14
Enrollment: 58
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: Modes of delivery impact maternal oxidative stress biomarkers and dynamic thiol disulphide homeostasis


Eligibility criteria: Inclusion Criteria:

For VD group:

* Women with spontaneous uncomplicated vaginal delivery
* Women who were in the 38th week and vertex presentation and whose contractions had started naturally.

For CS group:

• Women in their 38th week of pregnancy who delivered by elective CS without uterine contractions

Exclusion Criteria:

* Participants who were smokers
* Participants who had a non-optimal pre-pregnancy body mass index
* Systemic diseases such as diabetes mellitus and gestational hypertension.

Primary outcomes:
measure: Oxidative stress markers
timeFrame: From January 2021 to August 2021
measure: Oxidative stress markers
timeFrame: From January 2021 to August 2021
measure: Oxidative stress markers
timeFrame: From January 2021 to August 2021
measure: Oxidative stress markers
timeFrame: From January 2021 to August 2021
measure: Oxidative stress markers
timeFrame: From January 2021 to August 2021
measure: Oxidative stress markers
timeFrame: From January 2021 to August 2021
measure: Oxidative stress markers
timeFrame: From January 2021 to August 2021
measure: Oxidative stress markers
timeFrame: From January 2021 to August 2021
measure: Oxidative stress markers
timeFrame: From January 2021 to August 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Alanya Training and Research Hospital Gynecology and Obstetrics Department
Study officials:
References:
Clinical trial NCT01396538: Prevalence of Occult HBV Infection Among Anti-HBc Alone Group in Northern Taiwan
Official title: Prevalence of Occult HBV Infection Among Anti-HBc Alone Group in Northern Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HBV Coinfection
Keywords: anti-HBc alone ；occult HBV infection
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-07-18
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: anti-HBc alone（HBsAg(-)；Anti-HBs(-)；Anti-HBc(+)）；occult HBV infection（the presence of HBV DNA in the liver and blood, in the absence Occult HBV of detectable HBsAg

Brief summary: Atni-HBs to HBsAg and Anit-HBc was interpreted based on three hepatitis markers for clinical detection of HBV-infections. HBAg and Anti-HBs were negative and the Anit-HBc-positive referred to as Anti-HBc alone. When the Anti-HBc alone occurs, patients may be due to mutations in HBV HBsAg can not be detected due to (1), but if by the molecular diagnostics by polymerase chain reaction (PCR) technology can detect HBV DNA present. When Anti-HBc alone in patients with serum HBV DNA can be measured, then there may be occult HBV infection. In different countries, Occult HBV infection in the Anti-HBc Alone group had significant differences in the prevalence (2.9 \~ 22.8%) (2), but prevalence survey in Taiwan there are very few studies on this , It is hoped to be able to investigation the prevalence of occult HBV infection Among Anti-HBc Alone.

Detailed description: The main use of this program, Taipei Medical University - Wan Fang Hospital in clinical specimens using the Roche system (Corbas e601) operating HBsAg, Anti-HBs, Anti-HBc to screen for the Anti-HBc alone group. Recycling Roche molecular system (Taq48) Real-time PCR to detect all anti-HBc alone population to understand their serum HBV-DNA viral load, in order to understand Occult HBV infection in the Anti-HBc alone group, the prevalence and viral load changes in these studies through the clinical units to provide occult HBV infection as a reference basis.

Eligibility criteria: Inclusion Criteria:

HBsAg(-)；Anti-HBs(-)；Anti-HBc(+)

Exclusion Criteria:

None

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: Yi-Kue Chen, college
role: STUDY_DIRECTOR
References:
Clinical trial NCT04087538: A Prospective Comparison of Cardiac Troponin T and Troponin I in the Diagnosis of Myocardial Infarction
Official title: A Prospective Comparison of Cardiac Troponin T and Troponin I in the Diagnosis of Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Keywords: troponin
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 300
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: Two large acute medical centers will include patients for this study, one that routinely use cTnT (Hvidovre Hospital) and one that routinely uses cTnI (Herlev Hospital).

Each center will include consecutive patients over a period of 5 months clinically suspected of non-ST segment elevation myocardial infarction (NSTEMI). These patients will undergo serial measurement of either cardiac troponin T (cTnT) or cardiac troponin I (cTnI) as is standard practice. In addition to regular their lab tests, all patients will have extra blood samples set aside for a biobank.

At the end of the inclusion period, all patients sent to invasive coronary angiography (ICA) will be identified and included in the further analyses. As one center uses cTnT and one uses cTnI, patients will have either biomarker measured upon admission. The other cTn assay will be measured on all samples from the biobank, so every patient has at least one measurement of both cTnT and cTnI.

Brief summary: The rising number of patients with chest pain without myocardial infarction has made accurate diagnosis important. Unnecessary invasive coronary angiographies are increasingly prevalent. These are both costly and lead to rare but serious adverse events. Recent studies suggest cardiac Troponin I is more cardiac specific than cardiac Troponin T. In this study we will investigate whether using cardiac Troponin I lead to fewer unnecessary procedures in clinical practice (i.e. invasive coronary angiography and non-invasive tests)


Eligibility criteria: Inclusion Criteria:

* Admitted to either Herlev-Gentofte or Amager-Hvidovre Hospital
* Clinically suspected of NSTEMI
* Referred to invasive coronary angiography (ICA)
* Recieved at least one measurement of either troponin

Exclusion Criteria:

-

Primary outcomes:
measure: Specificity for MI
timeFrame: 0
measure: Cost-effectiveness
timeFrame: 0
Secondary outcomes:
measure: Sensitivity for MI
timeFrame: 0
measure: Elevated troponin without CAD
timeFrame: 0
measure: Number of MIs
timeFrame: 0
measure: PPV and NPV
timeFrame: 0
Other outcomes:
Locations:
city: Bispebjerg
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen
city: Herlev
country: Denmark
facility: Herlev-Gentofte Hospital
Study officials:
References:
Clinical trial NCT01118338: Evaluation of Two Different Designs of Bausch & Lomb Contact Lenses
Official title: A Study to Evaluate the Product Performance of Two Different Designs of Bausch & Lomb PureVision® Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: contact lens
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-05-06
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this one month study is to evaluate the product performance of a redesigned PureVision Contact Lens compared to the PureVision Contact Lens when worn on a daily wear basis by wearers of contact lenses.


Eligibility criteria: Inclusion Criteria:

* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be adapted wearers of one of the listed contact lenses
* Subjects must be myopic
* Subjects must use a lens care system on a regular basis.

Exclusion Criteria:

* Subjects who have worn gas permeable (GP) contact lenses within the last 30 days of polymethylmethacrylate (PMMA) lenses within the last 3 months.
* Subjects with any systemic disease affecting ocular health.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or are using any ocular medication.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects who have had any corneal surgery (eg, refractive surgery).
* Subjects who have participated in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.

Primary outcomes:
measure: Symptoms and Complaints
timeFrame: 1 month
Secondary outcomes:
measure: Visual Acuity
timeFrame: 1 month
measure: Percentage of Eyes With > Grade 2 Slit Lamp Findings
timeFrame: 1 month
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Gerard Cairns, MCOptom, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05227638: Investigation of the Efficacy of PNF and Schroth Treatment
Official title: Investigation of the Efficacy of PNF and Schroth Treatment in Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis; Adolescence
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
Collaborators: name: Kirsehir Ahi Evran Universitesi
First posted: 2022-02-07
Enrollment: 36
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: our study was to compare the advantages of Schroth and PNF methods used in AIS treatment

Detailed description: there are studies showing that Schroth and PNF are effective on AIS seperately. While there are studies showing that Schroth is particularly effective on AIS, the number of studies on PNF is insufficient. However, no evidence was found comparing the efficacy of Schroth and PNF. Therefore, the aim of our study was to compare the advantages of Schroth and PNF methods used in AIS treatment

Eligibility criteria: Inclusion Criteria:

* Participants were between ages 10-18
* Volunteered for the study.
* Diagnosed with adolescent idiopathic scoliosis
* Cobb angle between 10-30 degrees
* 0-3 Risser sign
* Lenke curve type 1

Exclusion Criteria:

* non-idiopathic scoliosis
* previous spinal surgery
* who had exercise contraindications who had rheumatological disease who had mental handicap and who another neuromuscular problem

Primary outcomes:
measure: Cobb angle
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Mehmet Hanifi KAYA
Study officials:
References:
Clinical trial NCT00092638: An Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-804)(COMPLETED)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Added to Existing Atorvastatin 10 mg or 20 mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Coronary Disease
Keywords: Elevated Cholesterol
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 450
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 purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.

Detailed description: The duration of treatment is 10 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with elevated cholesterol and coronary heart disease

Exclusion Criteria:

* Patients whose cholesterol levels measure within acceptable ranges as specified by the study requirements

Primary outcomes:
measure: Percentage of patients reaching their target LDL-C goal of </= 2.60 mmol/L, after 6 weeks of treatment.
Secondary outcomes:
measure: Safety and tolerability.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Cruz-Fernandez JM, Bedarida GV, Adgey J, Allen C, Johnson-Levonas AO, Massaad R. Efficacy and safety of ezetimibe co-administered with ongoing atorvastatin therapy in achieving low-density lipoprotein goal in patients with hypercholesterolemia and coronary heart disease. Int J Clin Pract. 2005 Jun;59(6):619-27. doi: 10.1111/j.1368-5031.2005.00565.x.