louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04166760: Metabolic Effects of Whey Compounds in Patients With Diabetes Mellitus Type 2.
Official title: Metabolic Effects of Whey Compounds in Patients With Diabetes Mellitus Type 2.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double blinded, randomized, crossover design
Primary purpose: TREATMENT

Brief summary: The main objective of our study is to investigate the metabolic effects of a i) ordinary whey protein (WHE) and ii) a specific whey protein fraction (speWHE) when the interventions are ingested by patients with type 2 diabetes 30 minutes prior to an oral glucose tolerance test (OGTT). We will also investigate the glucose response when the patients ingest the interventions at home in their own environment 30 minutes before breakfast and dinner (2days) and also monitor glucose levels without interventions (2 days).


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Type 2 diabetes (T2D) diagnosis
* No medical treatment or metformin/sulfonylureas(SU) alone in the treatment of T2D
* No daily use of protein drinks
* Hba1c between 40 mmol/mol and 69 mmol/mol
* 20 kg/m2 \< BMI \< 35 kg/m2
* Screening blood test: 1200 pmol/l \> C-peptid \> 370 pmol/l

Exclusion Criteria:

* Other diabetes medication than metformin/SU (e.g. insulin, GLP-1 analog, DPP-4 inhibitor, SGLT2-inhibitor)
* Affected screening blood test assessed by the primary investigator(PI)/sponsor
* Does not understand or speak danish
* Milk allergy
* PI finds the patient not fit (e.g. mental illness, too nervous or other)

Primary outcomes:
measure: Difference in iAUC for insulin between WHE and speWHE
timeFrame: OGTT, 3 hours.
Secondary outcomes:
measure: Differences in iAUC and concentration differences for GIP
timeFrame: OGTT 3 hours
measure: Differences in iAUC and concentration differences for GLP-1
timeFrame: OGTT 3 hours
measure: Differences in iAUC and concentration differences for glucagon
timeFrame: OGTT 3 hours
measure: Differences in iAUC and concentration differences for glucose
timeFrame: OGTT 3 hours
measure: Differences in iAUC and concentration differences for C-peptid
timeFrame: OGTT 3 hours
measure: Differences in iAUC and concentration differences for FFA
timeFrame: OGTT 3 hours
measure: Activity measurements
timeFrame: 5 days
measure: continuous glucose measurement (CGM)
timeFrame: 5 days
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital
Study officials:
affiliation: Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital
name: Niels Jessen, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01800760: Probiotics to Improve Women's Health
Official title: Probiotics to Improve Women's Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: healthy
obese
women
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2013-02-28
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the study is explore the effect of probiotics on plasma lipopolysaccharides (LPS) concentrations, as well as insulin and glucose levels, in obese women prior to and after dietary challenges (high carbohydrate meal, high fat meal).


Eligibility criteria: Inclusion Criteria:

* BMI=30-40 kg/m2
* Healthy, age 18 or older
* Not consuming yogurt or cultured milk regularly (\</= 1x/wk) or any probiotic supplement

Exclusion Criteria:

* Medical conditions or medications that may affect metabolism as determined by the PI.

Primary outcomes:
measure: Plasma LPS concentrations
timeFrame: five weeks
Secondary outcomes:
measure: Glucose concentrations
timeFrame: five weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Aline Andres, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02463760: Predicting Rupture of AAA by Anatomic and Hemodynamic Markers
Official title: Predicting Rupture of Abdominal Aortic Aneurysm (AAA) by Anatomic and Hemodynamic Markers From In-vivo and In-vitro Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Abdominal
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary and specialty care clinics and emergency room visits.

Brief summary: The purpose of the study is to investigate imaging findings, which can help us to predict factors contributing to abdominal aortic aneurysm growth and rupture.


Eligibility criteria: Inclusion Criteria:

* Individuals between 18 and 80 years old receiving medical care at University of Minnesota Medical Center who have a normal aorta CTA within the previous year
* Or patients with known AAA with growth rate of 0-0.2 cm/year
* Or patients with known AAA with growth rate of greater than 0.5 cm/year.

Exclusion Criteria:

* Subjects with ferromagnetic implants
* Penile implant
* Hip replacement
* History of shrapnel or shot gun injury
* Body mass index ≥ 30
* Cardiac pacemakers
* Severe claustrophobia
* Large tattoos on the torso

Primary outcomes:
measure: Imaging findings correlating with abdominal aortic aneurysm growth and rupture
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Michael Rosenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06346860: Comparing Intrathecal Morphine With Modified Thoracoabdominal Nerve Block Through Perichondral Approach in Major Abdominal Surgery
Official title: Comparing Postoperative Analgesic Effects of Intrathecal Morphine With Modified Thoracoabdominal Nerve Block Through Perichondral Approach in Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Postoperative Pain
Keywords: intrathecal morphine
Modified Thoracoabdominal Nerve Block Through Perichondral Approach
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Abdominal surgery causes severe postoperative pain due to retraction of the abdominal wall and direct manipulation of visceral organs. It leads to delayed postoperative recovery, increased postoperative morbidity and mortality. Intrathecal morphine, epidural analgesia and patient-controlled intravenous analgesia are used in postoperative pain management of abdominal surgeries. Intrathecal morphine is frequently used in many centers because it provides effective pain control. However; morphine has undesirable effects such as urinary retention, postoperative nausea and vomiting, and respiratory depression. Modified thoracoabdominal nerves block through perichondrial approach is a technique defined by the modification of the thoracoabdominal nerves block through perichondrial approach, in which local anesthetics are delivered only to the underside of the perichondral surface. The primary implication of this study is to compare postoperative pain scores and opioid consumption in patients undergoing major abdominal surgery with intrathecal morphine or modified thoracoabdominal nerves block through perichondrial approach.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old
* Patients undergoing major abdominal surgery

Exclusion Criteria:

* Patients with solid organ dysfunction
* Patients who receive opioid or corticosteroid medication prior to surgery
* Patients with bleeding diathesis
* Patients with psychiatric disorders
* Patients who can not be contacted after surgery

Primary outcomes:
measure: Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device
timeFrame: 48 hours
Secondary outcomes:
measure: Postoperative pain assessment with Numeric Rating Scale (NRS)
timeFrame: 48 hours
measure: Comparison of the frequency of treatment related complications
timeFrame: 48 hours
measure: Participant satisfaction
timeFrame: 48 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
Study officials:
References:
Clinical trial NCT01445860: Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics
Official title: A Phase 1, Open-Label, Fixed-Sequence Study To Estimate The Effect Of Repeated Dosing Of PF-03882845 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Volunteers
Keywords: DDI
pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-10-04
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to estimate the effect of multiple oral doses of PF-03882845 on the pharmacokinetics of simvastatin and simvastatin acid in healthy, adult subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy males and/or females of non-childbearing potential between the ages of 18 (or 21 based on country-specific age of consent) and 60 years, inclusive, at Screening. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical/safety laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 inclusive; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or inducers (eg, pheytoin, carbamazepine) or substrate (eg, simvastatin, quinidine) within 28 days or 5 half-lives (whichever is longer) prior to Day 1.
* Known history of hypersensitivity, allergy, severe adverse drug reaction or intolerance to simvastatin or other statins.

Primary outcomes:
measure: Composite (or Profile) of Pharmacokinetics
timeFrame: 15 days
Secondary outcomes:
measure: Number of patients with adverse events as a measure of safety.
timeFrame: 15 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00312260: Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents
Official title: Randomized Controlled Trial Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Pain
Analgesia
Gabapentin
Amitriptyline
Pediatrics
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2006-04-07
Enrollment: 34
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to compare the efficacy of gabapentin and amitriptyline for treating neuropathic pain in children in a randomized controlled trial.

Detailed description: Clinical experience and case reports suggest that both amitriptyline and gabapentin are effective treatments for neuropathic pain in children; however we do not know which drug is more effective for specific pain conditions or for specific children. This study will be the first prospective, randomized double-blind controlled trial directly comparing gabapentin and amitriptyline for the treatment of neuropathic pain in a paediatric population. We will also study the time course for pain reduction and evaluate changes in children's physical function, mood, and sleep. This information is needed to determine which drug is better for which children and which pain conditions.

Eligibility criteria: Inclusion Criteria:

* 8 - 17 years of age
* Diagnosis of neuropathic pain

Exclusion Criteria:

* Additional health problems
* Lactose intolerant
* Unable to swallow size 0 gelatin capsules
* Pregnant
* Unable to speak English

Primary outcomes:
measure: change in child's pain intensity score
timeFrame: 6 weeks
Secondary outcomes:
measure: change in child's pain-related disability ratings
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Stephen Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00836160: Comparing Efficacy Between Anti-microtubule and Non-anti-microtubule as 3th Therapy After 2nd Line EGFR-TKI Therapy
Official title: Comparing Efficacy Between Anti-microtubule and Non-anti-microtubule as 3th Therapy After 2nd Line EGFR-TKI Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: EGFR-TKI therapy
NSCLC
Efficacy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-02-04
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The EGFR-TKI receiver who are suitable for third-line therapy will be followed up for the regimen of the third-line anti-microtubule agents or non-anti-microtubule agents

Brief summary: This is an observational prospective study that investigates only daily practice. The prescription of anti-cancer medicine is separated from the decision to include the patient in this study. In addition, the assignment of the patient to a particular therapy or therapeutic strategy is not decided in advance by this study protocol, but falls within current practice.

The patient who fulfils eligible criteria will be enrolled when starts to receive the second-line EGFR-TKI therapy. The frequency of tumor response evaluation by RECIST criteria follows the investigator's discretion as daily practice.


Eligibility criteria: Inclusion Criteria:

* At least one measurable lesion according to RECIST criteria
* Histologically or cytologically confirmed NSCLC of adeno histology
* Locally progressed or metastasized on or after first-line chemotherapy. The imaging evidence of disease progression can be either chest X ray, CT or MRI assessment on measurable lesions. If no measurable lesion is available, evaluable lesions are acce

Exclusion Criteria:

-

Primary outcomes:
measure: PFS of the third-line therapy
timeFrame: 9 months
Secondary outcomes:
measure: Overall objective tumor response (complete response [CR] + partial response [PR]) of the third-line therapy by RECIST criteria
timeFrame: 9 months
Other outcomes:
Locations:
city: Gueishan Township
country: Taiwan
facility: Research Site
Study officials:
References:
Clinical trial NCT01038960: Exercise Training in ICD Recipients; Effect on Therapy Delivered, Depression and Anxiety
Official title: Exercise Training to Reduce Ventricular Arrhythmia in Heart Failure Patients With ICD - The Ethic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ventricular Tachycardia
Keywords: ICD, training
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Stavanger Health Research
First posted: 2009-12-24
Enrollment: 40
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: TREATMENT

Brief summary: Interventional study in patients with ICD. Controlled, open intervention with exercise training. Assessment of changes in physiological and psychological parameters.

Detailed description: ICD therapy with DC shock is associated with impaired quality of life and development of anxiety and depression. In a selected group of patients with ICD the intervention with organized high intensity training is evaluated. Peak VO2, inflammatory profile, performed interventions by the ICD and psychological profile is assessed. In addition a qualitative evaluation using interviews is performed.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria: Age 18 years or above, documented coronary heart disease, myocardial scar tissue verified by CMR, implanted ICD

Exclusion Criteria:

* Planned revascularisation by bypass surgery or percutaneous coronary intervention following the ICD implantation, planned arrhythmia ablation, long QT-syndrome, Brugada syndrome, WPW syndrome, Drug-induced torsades, catecholaminergic polymorphic ventricular tachycardia, Hypertrophic cardiomyopathy right ventricular cardiomyopathy, dilated cardiomyopathy, Aortic stenosis, mitral valve prolapse, anomalous origin of coronary arteries, Myocardial bridging, ongoing myocarditis, recent chest trauma,

Primary outcomes:
measure: Therapy delivered from ICD, Anxiety score, functional status
timeFrame: 3 months
Secondary outcomes:
measure: HRV, Endothelial function
timeFrame: 3 months
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger Health Research
Study officials:
affiliation: University of Bergen
name: Alf Inge Larsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02042560: Study of Immune Thrombocytopenia Pathogenesis:
Official title: Study of Immune Thrombocytopenia Pathogenesis: a Multicenter, Open and Controlled Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Immune Thrombocytopenia (ITP)
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ITP

Brief summary: Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a low platelet count responsible for bleedings. The disease is mostly mediated by antiplatelet antibodies produced by specific B cells. However, T cells are also involved but their role is not completely understood.

The aim of this study is to determine the implication of T cells in the pathogenesis of ITP, notably regulatory T cells (Treg, CD4+CD25highFoxp3+), cytotoxic T cells (CD3+CD8+) and T follicular helper cells (TFH, CD3+CD4+CXCR5+PD-1+ICOS+), in blood and in the spleen of primary ITP patients, compared to healthy controls.


Eligibility criteria: Inclusion Criteria:

* Patients with ITP, defined as thrombocytopenia \< 30 G/L, once causes related to infection, medication, systemic auto-immune disease or malignant hemopathy have been ruled out
* persons who have provided written informed consent

Exclusion Criteria:

* persons without national health insurance
* persons under 18 years old
* patients under guardianship
* pregnancy
* subjects suffering from a systemic auto-immune disease, cancer, a progressive infection, or treated with steroids or immunosuppressants.

Primary outcomes:
measure: blood level T cell in ITP patients and in healthy controls
timeFrame: baseline
measure: blood level T cell in ITP patients after treatments
timeFrame: change from baseline at 4 to 8 weeks
Secondary outcomes:
measure: blood level splenic T cell in ITP patients and in healthy controls
timeFrame: baseline
measure: frequency of innate immune cells (dendritic cells, monocytes, NK cells…) and their functions in blood and spleens, in patients and in controls
timeFrame: through study completion, an average of 3 years
measure: level of T follicular helper cell
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Dijon
country: France
facility: CHU de Dijon
city: Metz
country: France
facility: CHU de METZ
Study officials:
References:
Clinical trial NCT04299360: Comparison of Multi-point Pacing and Conventional CRT Through Non-invasive Hemodynamics Measurement and Global Longitudinal Strain Assessment
Official title: Comparison of Multi-point Pacing and Conventional CRT Through Non-invasive Hemodynamics Measurement and Global Longitudinal Strain Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Resynchronization Therapy
Lead sponsor: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Patients with standard indications to CRT satisfying the study Inclusion and Exclusion Criteria

Brief summary: Pilot, perspective, multi-center non-randomized study comparing Multi-point pacing and conventional CRT through non-invasive hemodynamics measurement and Global Longitudinal Strain assessment


Eligibility criteria: Inclusion Criteria:

* Recent or scheduled implantation of CRT-D system with quadripolar lead and MPP technology in patient with indications to CRT according to current guidelines

Exclusion Criteria:

* Patients in Atrial Tachycardia (AT) or Atrial Fibrillation (AF) at the time of the enrollment or with persistent or long-standing persistent/chronic AF
* NYHA IV patients
* Right Bundle Branch Block

Primary outcomes:
measure: Acute improvement in cardiac function (1)
timeFrame: 24-48 hours after CRT-D implantation
measure: Acute improvement in cardiac function (2)
timeFrame: 24-48 hours after CRT-D implantation
Secondary outcomes:
measure: Delayed response (1)
timeFrame: 3 Months
measure: Delayed response (2)
timeFrame: 3 Months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Policlinico Mater Domini
state: CZ
city: Napoli
country: Italy
facility: AO Cardarelli
city: Napoli
country: Italy
facility: AOU Federico II
Study officials:
References: