louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00569556: Effect of Care Management on Diabetes Outcomes
Official title: Effect of Care Management on Diabetes Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Chronic Care Model
Case Management
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2007-12-07
Enrollment: 550
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 the study is to determine if a nurse managed, protocol driven, disease management process for diabetes results in improved attainment of therapeutic goals for diabetes compared to usual care. It is hypothesized that implementation of the disease management process will improve the percentage of diabetic individuals attaining all three therapeutic targets (HgbA1C\<8.0%, LDL\<100mg/dl, and BP\<130/80mmHG) by 10% compared to usual care.


Eligibility criteria: Inclusion Criteria:

* Enrolled at Minneapolis VAMC
* Type 1 or 2 diabetes
* Blood pressure at screening visit \> 140mmHg systolic or \> 90mmHg diastolic OR HgbA1C at screening visit \> 9.0% OR LDL at screening visit \> 100mg/dL

Exclusion Criteria:

* Primary care provider unwilling to have participant included in study
* Life expectancy \< 1 year
* Unable to give consent
* Severe mental health condition
* pregnant or planning on becoming pregnant

Primary outcomes:
measure: Combined outcome of BP<130/80 mmHG, HgbA1C<8%, and LDL<100mg/dl at 1 year; the primary analysis will compare the intervention to usual care with respect to the percentage of diabetic individuals achieving all three therapeutic goals
timeFrame: one year
Secondary outcomes:
measure: Safety of the intervention (occurence of adverse events over the course of the trial)
timeFrame: one year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Veterans Affairs Medical Center
state: Minnesota
Study officials:
affiliation: Minneapolis VAMC
name: Areef Ishani, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Minneapolis VAMC
name: Nacide Ercan-Fang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ishani A, Greer N, Taylor BC, Kubes L, Cole P, Atwood M, Clothier B, Ercan-Fang N. Effect of nurse case management compared with usual care on controlling cardiovascular risk factors in patients with diabetes: a randomized controlled trial. Diabetes Care. 2011 Aug;34(8):1689-94. doi: 10.2337/dc10-2121. Epub 2011 Jun 2.
Clinical trial NCT03426956: Glucose Absorption and Gut Hormone Secretion After Gastric Bypass
Official title: Impact of Canaglifloxin on Gut Hormone Secretion After Gastric Bypass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Keywords: Glucagon-like Peptide-1
Glucose
Gastric bypass
Bariatric surgery
Obesity
Diabetes
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 10 gastric bypass patients
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the impact of canagliflozin on secretion of gut hormones, in particular glucagon-like peptide 1 (GLP-1) in gastric bypass operated patients.

Detailed description: Glucose is a potent stimulus for GLP-1 secretion after gastric bypass surgery and the SGLT-1 transporter appears to be crucial for this response. The study will investigate the effects of SGLT-1/SGLT-2 inhibition (by canagliflozin) on secretion of GLP-1 and other gut hormones after gastric bypass surgery.

Eligibility criteria: Inclusion Criteria:

•Uncomplicated gastric bypass surgery performed minimum 12 months prior to study

Exclusion Criteria:

* Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery
* Pregnancy or breastfeeding
* Haemoglobin levels below 6,5 mM

Primary outcomes:
measure: Difference in GLP-1 secretion (evaluated by iAUC).
timeFrame: 0-240 min following glucose ingestion
Secondary outcomes:
measure: Difference in glucose responses between the two test days.
timeFrame: 0-240 min following glucose ingestion
measure: Difference in insulin responses between the two test days.
timeFrame: 0-240 min following glucose ingestion
measure: Difference in C-peptide responses between the two test days.
timeFrame: 0-240 min following glucose ingestion
measure: Difference in Gastric Inhibitory Peptide (GIP) responses (evaluated by iAUC) between the two test days.
timeFrame: 0-240 min following glucose ingestion
measure: Difference in peptide YY (PYY) responses (evaluated by iAUC) between the two test days.
timeFrame: 0-240 min following carbohydrate ingestion
measure: Difference in glucagon responses (evaluated by iAUC) between the two test days.
timeFrame: 0-240 min following glucose ingestion
measure: Difference in oxyntomodulin responses (evaluated by iAUC) between the two test days.
timeFrame: 0-240 min following carbohydrate ingestion
measure: Difference in cholecystokinin (CCK) responses (evaluated by iAUC) between the two test days.
timeFrame: 0-240 min following glucose ingestion
measure: Difference in bile acid responses (evaluated by iAUC) between the two test days.
timeFrame: 0-240 min following glucose ingestion
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Dept. of Endocrinology
Study officials:
References:
Clinical trial NCT01703156: Low Risk Acute Coronary Syndrome
Official title: Stress Testing Versus Non-Stress Testing Based Strategy in Patients Hospitalized With Low-Risk Acute Coronary Syndromes: A Randomized, Single-Center Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Risk Acute Coronary Syndrome
Keywords: Low Risk ACS, Acute Coronary Syndrome, Stress Testing, Non-Stress Testing
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: VA Office of Research and Development
First posted: 2012-10-10
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A large number of patients are diagnosed with low risk ACS, and these individuals are at significant cardiovascular risk. Though guidelines recommend stress testing to manage low risk ACS patients, evidence supporting this recommendation is not based on trials examining this population. A well-designed, randomized trial is warranted to determine if stress testing is useful in managing low risk ACS. If medical therapy alone is equivalent as the investigators hypothesize, healthcare expenditures could be reduced and patients may not be exposed to the harms associated with more invasive cardiac testing such as coronary angiography.


Eligibility criteria: Inclusion Criteria:

1. TIMI score \< or = to 2(12)
2. TIMI risk score of 3 with no known CAD, greater than 50% in one or more vessels
3. Normal cardiac biomarkers (3 sets over 12-88 hours)
4. No evidence of acute ischemia on electrocardiograms
5. Normal ejection fraction (\>40%) on echocardiography
6. Age 30-75
7. Ability to complete noninvasive stress test
8. Ability to provide informed consent

Exclusion Criteria:

1. Presence of another medical condition to explain chest pain or non-cardiac chest pain (i.e. pneumonia, costochondritis)
2. Any patient who is initially classified as low risk but whom develops recurrent symptoms of ischemia, hemodynamic instability, or arrhythmias attributable to ischemia
3. Evidence of ischemia on electrocardiogram
4. Abnormal cardiac biomarkers
5. History of medical noncompliance or social circumstances preventing compliance
6. Life span estimated at \<1 year
7. Pregnancy
8. Refusal to sign consent

Primary outcomes:
measure: Composite of all-cause mortality, hospitalization for UA/NSTEMI or STEMI, and urgent revascularization
timeFrame: one year
Secondary outcomes:
measure: Secondary endpoints will include mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects.
timeFrame: one year
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Veteran's Affairs Medical Center
state: Oklahoma
Study officials:
affiliation: OUHSC and VAMC OKC
name: Mazen S Abu-Fadel, MD, FACC, FSCAI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06299956: Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark
Official title: Supervised Exercise-based Rehabilitation for People With Intermittent Claudication - Study Protocol for a Danish Implementation Process (StRiDE).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intermittent Claudication
Keywords: Exercise therapy
Smoking cessation
Implementation
Stakeholders
Walking
Treadmill
Lead sponsor: Slagelse Hospital
Sponsor class: OTHER
Collaborators: name: Region Zealand
name: Vordingborg Municipality
name: Kalundborg municipality
name: Køge Municipality
name: Næstved municipality
name: Solrød Municipality
First posted: 2024-03-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this project is to implement a protocol for a supervised exercise therapy intervention including smoking cessation in the municipalities in region Zealand in Denmark. The participants are adults with intermittent claudication.

The objective of this project is to describe:

1. The development and design of the implementation process of a rehabilitative intervention including SET and smoking cessation in Region Zealand with a 6-month follow-up period after completion of the SET.
2. The ongoing quality monitoring process of the implementation in terms of referral, recruitment, retention, data completeness, intervention delivery and attendance and to collect feedback that will guide refinements of the intervention delivery and data collection.
3. Outcomes available for assessment of benefits and harms from the SET intervention.

Participants will be asked to do supervised exercise therapy by walking on a treadmill for 3 times a week for 12 weeks, and engage in smoking cessation, if they are smoking.


Eligibility criteria: Inclusion criteria:

* Relevant symptoms of intermittent claudication; leg pain when walking due to arteriosclerosis and relieve of symptoms during rest.
* Distal blood pressure with an ankle-brachial index (ABI) \> 50 mmHg for non-diabetics or toe brachial index (TBI) \> 40 mmHg for diabetics.

Exclusion criteria:

• Evaluated by a vascular surgeon: patients with contraindications e.g. medical issues or comorbidity that enables a participation in SET are not referred.

Primary outcomes:
measure: Maximal Walking Distance
timeFrame: Baseline, 12 weeks and 6 months from end of intervention
Secondary outcomes:
measure: Pain-free walking distance
timeFrame: Baseline, 12 weeks and 6 months from end of intervention
measure: Vascular Quality of Life Questionnaire-6 (VASCUQoL-6)
timeFrame: Baseline, 12 weeks and 6 months from end of intervention
Other outcomes:
Locations:
city: Slagelse
country: Denmark
facility: PROgrez
Study officials:
affiliation: Slagelse Hospital
name: Helle Bøgard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01466556: The Incidence of Metabolic Syndrome Among Obese Children in Our Region
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-11-08
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children who visit our outpatient clinic or a routine visit to the ER

Brief summary: The aim of this study is to determine the prevalence of metabolic syndrome amongst obese children in our region with a body mass index (BMI) above the 95th percentile for age and sex.


Eligibility criteria: Inclusion Criteria:

* Children with BMI over 95 percentile

Exclusion Criteria:

* Obesity secondary to medication use
* Obesity secondary to genetic disease

Primary outcomes:
measure: Incidence of children with metabolic syndrome
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT04867356: Effects Of Latissimus Dorsi Stretching On Functional Disability Related To Chronic Low Back Pain
Official title: Effects Of Latissimus Dorsi Stretching On Functional Disability Related To Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Low Back Pain
Lead sponsor: Health Education Research Foundation (HERF)
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to determine effects of latissimus dorsi stretching on functional disability related to chronic low back pain

Detailed description: A single-blinded,randomized clinical trial will be conducted in /multiple rehabilitation centers of Rawalpindi and Islamabad, after taking approval from ERB/IRB respective centers. The study duration will be 3 months. the study participants will be having mechanical low back pain.

The intervention will be included latissmus dorsi stretching along with spinal stabilization exercises in one group and in comparative group spinal stabilization exercises alone. Oswestry Disability Index (ODI) will be used to measure the disability related to the chronic low back pain.

Eligibility criteria: Inclusion Criteria:

* male and female
* 20 to 60 years
* chronic mechanical low back pain

Exclusion Criteria:

* patients who had any type of injury or fracture which limits rehabilitation
* patients with the symptoms of radiating pain
* who had disc pathology and spinal cord injury
* patients with medical conditions

Primary outcomes:
measure: Oswestry disability index
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mānsehra
country: Pakistan
facility: NOSIS clinics Mansehra Pakistan
Study officials:
References:
Clinical trial NCT05635656: Digital Solutions for Concussion
Official title: Digital Symptom Mapping and Home-based Biofeedback Treatment for Adults with Persistent Postconcussion Symptoms: a Development and Usability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Concussion Syndrome
Post-Traumatic Headache
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this study is to develop new digital solutions for patients with prolonged postconcussion symptoms, and investigate its usability, feasibility, and safety. The digital solutions consist of a 1) symptom mapping and clinical decision support system, and 2) a research-based system for home-based biofeedback treatment.


Eligibility criteria: Inclusion Criteria:

* 18 or older at the time of inclusion.
* Mild TBI as defined by having sustained a head injury with observed or self-reported alteration of consciousness, amnesia, or other relevant acute symptoms.
* PPCS according to the ICD-10 research criteria and PTH according to International Classification of Headache Disorders 3rd edition (ICHD-3). Operationalized as reporting 3 or more symptoms (including headache) on a moderate or greater intensity level on the RPSQ.
* Proficient in Norwegian language (oral and written)
* Signed informed consent

Exclusion Criteria:

* Serious psychiatric or somatic disease, or other patient-related factors, that based on an evaluation of the study personnel responsible for inclusion, will provide obvious challenges for adhering to the protocol, including using the devices.
* Less than three months of experience with smartphones
* Not having access to an iOS or Android smartphone

Primary outcomes:
measure: Usability of new digital solutions for symptom mapping and home-based biofeedback treatment in patients with PPCS/PTH
timeFrame: Will be assessed at three different time points: After each usability testing during the iterative development cycles (T1 and T2) and after the home-testing period (T3).
Secondary outcomes:
measure: Feasibility and adherence of new digital solutions
timeFrame: Will be assessed after the home-testing period (T3)
Other outcomes:
measure: Safety of new digital solutions
timeFrame: Will be assessed at three different time points: After each usability testing during the iterative development cycles (T1 and T2) and after the home-testing period (T3).
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
References:
Clinical trial NCT02845856: Combination of Cetuximab and NK Immunotherapy for Recurrent Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Recurrent Non-small Cell Lung Cancer
Keywords: recurrent lung cancer
EGFR mutation
Cetuximab
NK immunotherapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2016-07-27
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of Cetuximab plus natural killer(NK) immunotherapy to recurrent non-small cell lung cancer with EGFR mutation.

Detailed description: By enrolling patients with lung cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using Cetuximab and NK cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree evaluated by RECIST
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival (PFS)
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital, Guangzhou
name: Jibing Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01423656: Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects by Dermal Application of a LEO 29102
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2011-08-26
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 29102 is administered cutaneously as single and multiple doses to healthy subjects.

The study is divided into one single dose part, one part to compare pharmacokinetics between gender and one multiple dose part.


Eligibility criteria: Inclusion Criteria:

* Subjects will be Caucasian males and females between 18 and 55 years of age and with a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive.
* Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations

Exclusion Criteria:

* Subjects who suffer from, or show signs of eczema or other skin lesions.
* Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity), or a marketed drug within the past 3 months prior to the first dosing occasion.
* Subjects with a significant history of drug allergy as determined by the Investigator.
* Subjects with known immunocompromised state due to treatment with immunosuppressive drugs or due to history of a disease leading to immunocompromised status.

Primary outcomes:
measure: Number of subjects with adverse events (AEs) and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate and oral body temperature), ECG, telemetry,clinical laboratory and local tolerability assessments
timeFrame: 7 days after last dosing
Secondary outcomes:
measure: LEO 29102 and metabolites in blood and urine
timeFrame: 72 hours after dosing
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit Ltd.
Study officials:
affiliation: Covance
name: Ashley Brooks, MBChB
role: PRINCIPAL_INVESTIGATOR
References: