louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02517242: Syringes Replacement for Insulin Application for Pens Device in a Population of Elderly Patients With Type 2 Diabetes: Multifactorial Intervention to Improve Glycemic Control
Official title: Syringes Replacement for Insulin Application for Pens Device in a Population of Elderly Patients With Type 2 Diabetes: Multifactorial Intervention to Improve Glycemic controlCONTROL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 112
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, intervention, randomized, phase IV study. Patients will be included with 60 years or older, both sexes, with HbA1c \>8.5% using oral antidiabetics agents and insulin and then we will be randomized by use syringe or pens device to use insulin NPH and regular. All patients will receive a blood glucose monitor, lancet tapes, capillary blood glucose tests (3 tests/day). HbA1c will be measured at baseline, 3 and 6 months. Patients will see monthly.


Eligibility criteria: Inclusion Criteria:

* Sixty years or older
* Diabetes type 2 with Glycated Hemoglobin higher than 8.5%
* Using or necessity to use insulin
* Using syringe to insulin
* Using at least one oral antidiabetic
* Accept to participate

Exclusion Criteria:

* Glomerular Filtration Rate lower than 30
* Considering unfit for self administration of insulin

Primary outcomes:
measure: Glycated Hemoglobin
timeFrame: reduction compared to baseline values at six months
Secondary outcomes:
measure: Blood Pressure
timeFrame: reduction compared to baseline values at six months
measure: adherence
timeFrame: reduction compared to baseline values at six months
measure: Number of pills, antidiabetics drugs and antihypertensives drugs
timeFrame: reduction compared to baseline values at six months
measure: Number of hypoglycemias
timeFrame: reduction compared to baseline values at six months
measure: Presence of severe hypoglycemias
timeFrame: reduction of the number of patients with this outcome compared to baseline values at six months
measure: Presence of nocturnal hypoglycemias
timeFrame: reduction of the number of patients with this outcome compared to baseline values at six months
measure: Presence of asyntomatic hypoglycemias
timeFrame: reduction of the number of patients with this outcome compared to baseline values at six months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Rafael Vaz Machry
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Ticiana da Costa Rodrigues
role: PRINCIPAL_INVESTIGATOR
References:
citation: Machry RV, Cipriani GF, Pedroso HU, Nunes RR, Pires TLS, Ferreira R, Vescovi B, de Moura GP, Rodrigues TC. Pens versus syringes to deliver insulin among elderly patients with type 2 diabetes: a randomized controlled clinical trial. Diabetol Metab Syndr. 2021 Jun 12;13(1):64. doi: 10.1186/s13098-021-00675-y.
Clinical trial NCT02112942: Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects
Official title: A Phase I Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Keywords: Hepatitis C virus
HCV
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2014-04-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be evaluated. Antiviral activity will also be assessed in HCV-infected subjects.


Eligibility criteria: Inclusion Criteria:

All subjects

* Subjects are in good general health.
* Subjects have provided written informed consent form.
* All subjects of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug. HCV Subjects
* Documented clinical history compatible with chronic hepatitis C without cirrhosis.
* Treatment-naïve
* HCV Genotype 1

Exclusion Criteria:

All subjects

* Pregnant or breastfeeding
* Co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
* Decompensated liver disease
* Other clinically significant medical conditions or laboratory abnormalities.

Primary outcomes:
measure: Safety and tolerability assessment
timeFrame: up to 35 days
Secondary outcomes:
measure: Pharmacokinetic
timeFrame: Up to 120 hours post dose
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00257842: Randomized Controlled Trial of Biofeedback Therapy for Dyssynergic Defecation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dyssynergia
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2005-11-23
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Constipation is a common disorder and current treatments are unsatisfactory. Biofeedback may help patients with constipation and dyssynergic defecation, but its efficacy is unproven and whether this is due to behavioral modification or excessive attention is unknown. Methods: In a prospective randomized trial, the investigators investigated the efficacy of Biofeedback (manometric- assisted anal relaxation, muscle coordination and simulated defecation training), with either sham feedback therapy (Sham) or standard therapy (diet, exercise, laxatives; Standard) in 77 subjects (69 women) with dyssynergic defecation. Primary outcome measures included presence of dyssynergia, balloon expulsion time, number of complete spontaneous bowel movements (CSBM), and global bowel satisfaction. Data analyzed per protocol.


Eligibility criteria: Inclusion Criteria:Patients were included if they fulfilled Rome II criteria for functional constipation, and during attempted defecation demonstrated a dyssynergic pattern of defecation, and either had prolonged difficulty with expelling a simulated stool (\> 1 minute) or prolonged delay (\> 20% marker retention) in colonic transit.

Exclusion Criteria: They were required to have no evidence of structural or metabolic diseases that could cause constipation, as assessed by colonoscopy/barium enema and routine hematological, biochemical and thyroid function tests. Patients taking drugs known to be constipating, for example opioids were either excluded or were asked to discontinue the drug prior to enrollment. Other exclusion criteria included: severe cardiac or renal disease, previous gastrointestinal, spinal or pelvic surgery except cholecystectomy, hysterectomy or appendectomy, neurologic diseases such as multiple sclerosis, stroke or spinal injury, impaired cognizance (mini-mental score \< 15), legal blindness, pregnancy, rectal prolapse, anal fissure, and alternating constipation and diarrhea.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Satish SC Rao, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01916642: A Dose-response Study of Lidocaine and Etomidate
Official title: Can Intravenous Lidocaine Decrease the Minimal Inducing Dose of Etomidate?: A Randomized Placebo-controlled Dose-response Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Etomidate Overdose of Undetermined Intent
Keywords: iv lidocaine
inducing dose
etomidate
dose response
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: IV lidocaine administration can reduce the minimal amount of Etomidate and time for induction of anesthesia.

Detailed description: The study was carried out in West China Hospital of Sichuan University, Chengdu, China. All the patients were informed in detail about the procedure and the medications they are going to get. Patients are well informed about the beneficial and possible hazards of the medicines and procedure. Patients are also informed that they can withdraw from the study at any time if they find it uncomfortable or harmful for them. Patients' written informed consent was obtained and registered for the permission from the Hospital's Ethics Board.

Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for Elective Surgery,
2. age limit within 18-70 years,
3. American Society of Anaesthesiologists physical status classification I-II

Exclusion Criteria:

1. Adrenal Cortex disorder,
2. Neurologic disease,
3. Psychiatric disorders,
4. Allergic to Local anesthetic drugs,
5. Patients who have received sedatives,analgesics or opioids within the previous 24 hrs.

Primary outcomes:
measure: changes in blood pressure and heart rate.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: Liu Jin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05225142: 10 Year Follow up of RCT Comparing Different Regenerative Regenerative Procedures
Official title: Modified Minimally Invasive Surgical Technique in Human Intrabony Defects With or Without Regenerative Materials 10-year Follow-up of a Randomized Clinical Trial: Tooth Retention, Periodontitis Recurrence and Costs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: The European Research Group on Periodontology (ERGOPerio)
Sponsor class: NETWORK
First posted: 2022-02-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Long term follow up of RCT
Primary purpose: TREATMENT

Brief summary: Evaluate the 10-year stability clinical, radiographic outcomes obtained with the application of the modified minimally invasive surgery to deep pockets associated with intrabony defects.

Detailed description: This 10-year follow-up of a randomized controlled clinical trial (Cortellini \& Tonetti 2011) compares three treatment modalities in deep intrabony defects: i) a control group was treated with modified minimally invasive surgical technique alone (M-MIST, N=15); ii) a second group was treated with M-MIST combined with enamel matrix derivative (M-MIST EMD, N=15, Straumann, Switzerland); iii) a third group was treated with M-MIST+EMD plus Bone Mineral Derived Xenograph (M-MIST+EMD+BMDX, N=15, Geistlich, Switzerland) . The design of the original trial has been reported along with the one-year results and the details of randomization and allocation concealment (Cortellini \& Tonetti 2011). Clinical outcomes of the three groups were longitudinally followed for 10 years. The 10-year follow-up was approved by the local ethical committee for clinical research of the Health Service of Tuscany (University Hospital of Firenze protocol ATRO2019, registration n° 15106_oss). All patients gave informed consent to participate into the clinical trial.

Eligibility criteria: Inclusion Criteria:

* Subjects with periodontitis
* Presence of one intrabony defect not extending into furcation
* Good general health
* Adequate plaque control

Exclusion Criteria:

* Furcation involvement in the experimental tooth
* Inadequate control of periodontitis

Primary outcomes:
measure: Clinical attachment level changes
timeFrame: 10 years
Secondary outcomes:
measure: Probing pocket depts
timeFrame: 10 years
measure: Tooth survival
timeFrame: 10 years
measure: Complication-free survival
timeFrame: 10 years
measure: Cost of recurrence
timeFrame: 10 years
measure: Radiographic bone level
timeFrame: 10 years
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Studio Cortellini
Study officials:
affiliation: ATRO - ERGOPERIO
name: Pierpaolo Cortellini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00980642: Accuracy of the Drager Dual-sensor Temperature Measurement System
Official title: Accuracy of the Draeger Dual-sensor Temperature Measurement System in The Perioperative Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia; Anesthesia
Keywords: surgery
thermometer
non-invasive
interoperative core temperature
anesthesia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-09-21
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Our primary hypothesis is that the Draeger dual-sensor temperature monitoring system, used at the forehead, is sufficiently accurate compared to tympanic, bladder or esophageal temperature and oral temperature for routine clinical use during hypothermic conditions, as well as during fever.

Detailed description: We will include patients undergoing general anesthesia or regional anesthesia. The temperature recorded by Draeger dual-sensor monitoring system will be obtained at 5-minute interval.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing trauma surgery with general anesthesia
* Patients undergoing orthopedic surgery with regional anesthesia

Exclusion Criteria:

* Younger than 18 or older than 80 years of age
* Have a pre-existing nasogastric tube
* Require bispectral index monitoring
* Upper esophageal disease
* Forehead rash or infection
* Oral infection or trauma
* Ear infection or drainage

Primary outcomes:
measure: The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature
timeFrame: From anesthesia induction to the end of surgery
Secondary outcomes:
measure: Sensitivity for Detection of Hypothermia
timeFrame: From anesthesia induction to the end of surgery
measure: Specificity for Detection of Hypothermia
timeFrame: From anesthesia induction to the end of surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Andrea Kurz, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Daniel I Sessler, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00104442: Study of the Effects of Current Drug Treatments on Levels of Certain Brain Chemicals in Alzheimer's Disease
Official title: Study of the Effects of Current Drug Treatments on Levels of Certain Brain Chemicals in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
memory loss
dementia
senility
forgetful
geriatric
behavior
mood swings
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-03-01
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Alzheimer's disease is a medical illness that damages the brain and causes problems with memory, mood and behavior. A substance called acetylcholine (ACh), which is naturally produced in the body, plays an important role in the normal functioning of the brain. In subjects with Alzheimer's disease, the level of ACh is greatly reduced. Currently, there are three commonly prescribed drugs used for treating the symptoms of Alzheimer's disease by helping to maintain the level of ACh in the brain. This study will evaluate how much each of these drugs changes the levels of certain brain chemicals that are known to, or may play an important role in, Alzheimer's disease and its symptoms.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of mild to moderate Alzheimer's disease
* Must be able to swallow capsule/tablet
* Must have a caregiver who is available to attend all study visits

Exclusion Criteria:

* Digestive problems related to peptic ulcer
* Experienced a heart attack or stroke in the last 6 months
* Serious/unstable asthma or severe pulmonary (lung) disease
* On current treatment with a blood thinner

Primary outcomes:
measure: Changes in specific brain enzyme activity from baseline to week 13
Secondary outcomes:
measure: Correlate changes in specific brain enzyme activity at week 13 to cognition and behavior
measure: Changes in levels of protein biomarkers in Alzheimer's disease and neurodegeneration from baseline to week 13
measure: Correlate changes in specific brain enzyme activity after 13 weeks treatment to changes in global functioning at 13 and 26 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
References:
Clinical trial NCT03318042: Genotype, Metabotype and Diet in a Cohort of Children and Adolescents From the Southeast of Spain.
Official title: Association Between Genotype, Polyphenol Gut Microbiota Metabotypes, and Diet in a Cohort of Children and Adolescents From the Southeast of Spain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genotype, Metabotype and Dietary Habits
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
Collaborators: name: CEIP (primary school) Jara Carrillo (Alcantarilla, Murcia, Spain)
name: IES (secondary school) Alcántara (Alcantarilla, Murcia, Spain)
name: IMDEA Food
First posted: 2017-10-23
Enrollment: 423
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The objective of this study is to investigate the possible association between 60 SNPs related to obesity, metabolism and cardiovascular disease with BMI, intestinal microbiota and adherence to the Mediterranean diet in a cohort of children and adolescents from the southeast of Spain.

Detailed description: The objective of this study is to investigate the possible association between 60 single nucleotide polymorphisms (SNPs) related to obesity, metabolism and cardiovascular disease with the body mass index (BMI), intestinal microbiota related to the metabolism of polyphehnos and adherence to the Mediterranean diet in a cohort of children and adolescents from the southeast of Spain.

The volunteers (n=423) with ages ranging from 5 to 18 years consumed for three days a daily serving of walnuts (30g) and provided a sample of urine (to determine mirobial-derived metabolites from walnut polyphenols) as well as a swab specimen from the inner cheek to provide DNA for further genotyping.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals aged 5 to 18 years.
* Informed consent signed by the parent / legal representative, and by volunteers who are already 18 years old.

Exclusion Criteria:

* Known or suspected allergy or intolerance to nuts or pomegranate.
* Intake of antibiotics 1 month before the start of the study.
* If the participant could perceive stress or psychological damage due to his participation.
* Any other circumstance different from previous ones (illness, etc.), according to which it is considered that the intervention in the study may involve some type of affectation.

Primary outcomes:
measure: Polyphenol metabotypes
timeFrame: 1 to 3 months
Secondary outcomes:
measure: Genotype
timeFrame: 1 to 6 months
measure: Adherence to Mediterranean diet
timeFrame: 1 to 3 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Cebas-Csic
Study officials:
affiliation: Spanish National Research Council (CSIC)
name: Juan C. Espin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00536042: Open-Label Trial of the Use of Minocycline in the Treatment of Asthma
Official title: Open-Label Trial of the Use of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: minocycline
asthma
oral steroids
IgE
Lead sponsor: State University of New York - Downstate Medical Center
Sponsor class: OTHER
First posted: 2007-09-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The tetracycline minocycline has, in addition to its anti-infective properties, anti-inflammatory properties which may be of use in the treatment of asthma. This study evaluates the benefit of minocycline as add-on therapy for adults with asthma.

Detailed description: Adult asthmatic (ages 18 to 75 years) with a history of moderate to severe persistent asthma are given minocycline capsules as add-on therapy for treatment of asthma. Treatment is for one year. Dosing begins at 150 mg twice daily and can increase every eight weeks by 50mg BID to a maximum of 250 mg twice daily. This is as per patient tolerance as minocycline can cause dizziness and stomach upset, as well as effects of liver enzymes.Patients undergo routine blood toxicity screens every two months, at which time spirometry is performed Exclusion criteria: pregnant women (adequate contraception in mandated) previous history of hypersensitivity to tetracyclines, chronic liver disease Outcome measures: improvement in FEV1 and other spirometric parameters, decrease in oral steroid requirements, change in total serum IgE, improvement in quality of life

Eligibility criteria: Inclusion Criteria:

* Adults (ages 18 to 75 yrs)
* Mild to severe asthma
* History of or current oral steroid use to control asthma atopy

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Improvement in FEV1 on spirometry
timeFrame: one year
Secondary outcomes:
measure: decrease in total serum IgE
timeFrame: one year
measure: decrease in oral steroid requirements
timeFrame: one year
measure: improvement in quality of life scores
timeFrame: one year
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
Study officials:
affiliation: State University of New York - Downstate Medical Center
name: Rauno Joks, MD
role: PRINCIPAL_INVESTIGATOR
References: