louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01028599: Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients
Official title: Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Transplantation
Exercise Capacity
Endothelial Function
Keywords: Heart transplantation
Exercise capacity
Endothelial function
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2009-12-09
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effect of physical training on work capacity and vascular function after heart transplantation, cardiac transplant recipients are randomized to 8 weeks of intense physical training or control. Vascular function is measured non-invasively. Effect on the hormones and the immune system is evaluated using blood samples.

Detailed description: To investigate the effect of physical training on work capacity and vascular function after heart transplantation, cardiac transplant recipients are randomized to 8 weeks of intense physical training or control. Vascular function is measured non-invasively using forearm flow mediated dilatation. Effect on the blood natriuretic peptides and the inflammatory markers is evaluated using blood samples at baseline and after the training or control period.

Eligibility criteria: Inclusion Criteria:

* Heart transplant recipients \> 1 year after transplantation

Exclusion Criteria:

* Recent rejection, severe renal dysfunction, graft dysfunction, allograft vasculopathy, cancer, inability to exercise.

Primary outcomes:
measure: Change in maximal oxygen uptake.
timeFrame: 8 weeks
Secondary outcomes:
measure: Change inm flow mediated vasodilatation.
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Department of Cardiology, Rigshospitalet
name: Finn Gustafsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Monk-Hansen T, Dall CH, Christensen SB, Snoer M, Gustafsson F, Rasmusen H, Prescott E. Interval training does not modulate diastolic function in heart transplant recipients. Scand Cardiovasc J. 2014 Apr;48(2):91-8. doi: 10.3109/14017431.2013.871058. Epub 2014 Jan 27.
Clinical trial NCT00769899: AZD7325 Single Ascending Dose Study in Healthy Male Japanese Subjects
Official title: A Phase I,Single-Center,Randomised,Double-Blind,Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7325 in Healthy Male Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: AZD7325
Japanese Healthy Volunteers
Phase I study
Single Ascending Dose
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-09
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase I randomized double-blind, placebo-controlled, single centre study to assess the safety, tolerability and pharmacokinetics of AZD7325 following single ascending dose administration to healthy male Japanese volunteers.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) : 18 to 27 kg/m 2

Exclusion Criteria:

* Clinically relevant disease and/or abnormalities (past or present)
* Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
* Use of any medication or herbal preparation within 14 days of Study day 1 through the Follow-up Visit other than paracetamol (up to 3 g/day)
* Smoking in excess of 5 cigarettes per day or the equivalent within 28 days prior to the first study day or inability to refrain from smoking during the study confinement period

Primary outcomes:
measure: Safety and tolerabilityThe nature and incidence of adverse events (AEs), vital signs,physical examinations,electrocardiograms (ECGs)and laboratory assessments.
timeFrame: During the study
Secondary outcomes:
measure: Pharmacokinetic parameters for AZD7325
timeFrame: During residential period
measure: Genetic analysis of the genes involved in the pharmacokinetics and safety and tolerability to AZD7325 treatment may be performed. Participation in the exploratory genetic study is optional for the subjects.
timeFrame: During the study
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Research Site
state: California
city: Baltimore
country: United States
facility: Research Site
state: Maryland
Study officials:
affiliation: California Clinical Trials
name: Mark Yen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01142999: Feasibility Study of Barrier Enhancement for Eczema Prevention
Official title: Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eczema
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2010-06-14
Enrollment: 46
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this protocol is to determine the feasibility of doing larger follow-up studies examining whether emollients used from birth can prevent eczema in high-risk babies and to help investigators find out if emollients (moisturizing skin creams) used from birth can prevent eczema in high-risk babies. Hypothesis: Enhancing the skin barrier from birth using emollients will prevent or delay the onset of eczema, especially in predisposed infants.


Eligibility criteria: Inclusion Criteria:

1. Participant must have a parent or sibling with a history of at least one of the following: eczema, allergic rhinitis or asthma
2. Infant in overall good health
3. Mother between the ages of 16 and 45 years of age at delivery; infant from birth thru 6 months of age
4. Capable of giving informed consent

Exclusion Criteria:

1. Preterm birth defined as birth prior to 37 weeks gestation
2. Major congenital anomaly
3. Hydrops fetalis
4. Significant dermatitis at birth not including seborrheic dermatitis ("cradle cap")
5. Any immunodeficiency disorder or severe genetic skin disorder
6. Any other serious condition that would make the use of emollients inadvisable
7. Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention

Primary outcomes:
measure: Proportion of families willing to be randomized.
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of families eligible for the trial, willing to participate
timeFrame: 6 months
measure: Proportion of families who found the interventions acceptable
timeFrame: 6 months
measure: Reported adherence with intervention
timeFrame: 6 months
measure: Proportion of families for whom the blinding of the assessor to the allocation ostatus was not compromised
timeFrame: 6 months
measure: Amount of contamination as a result of increased awareness in the control group
timeFrame: 6 months
measure: Percentage of missing data and early withdrawal rates
timeFrame: 6 months
measure: Incidence of emollient-related adverse events
timeFrame: 6 months
measure: Incidence of eczema at 6 and 12 months
timeFrame: 12 months
measure: Age at onset of eczema
timeFrame: 6 months
measure: Filaggrin mutation status
timeFrame: 6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Eric L. Simpson, M.D., M.C.R.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02483299: Liraglutide as Add on Therapy on Metformin in Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PCOS
Obesity
Keywords: response to therapy
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine whether combined treatment with liraglutide and metformin is more effective than metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy.


Eligibility criteria: Inclusion Criteria:

* 18 years old to menopause
* polycystic ovary syndrome (NICHD criteria)
* BMI of 30 kg/m² or higher

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* history of carcinoma
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* personal or family history of MEN 2
* significant cardiovascular, kidney or hepatic disease
* the use of medications known or suspected to affect reproductive or metabolic functions
* the use of statins, within 90 days prior to study entry

Primary outcomes:
measure: Change in body weight
timeFrame: up to 12 weeks of clinical trial
measure: The number of good responders to combined treatment regarding body weight
timeFrame: up to 12 weeks of clinical trial
Secondary outcomes:
measure: Change in body mass index (BMI).
timeFrame: up to 12 weeks of clinical trial
measure: Change in waist circumference
timeFrame: up to 12 weeks of clinical trial
Other outcomes:
measure: Change in fasting concentrations of glucose
timeFrame: up to 12 weeks of clinical trial
measure: Change in fasting concentration of insulin
timeFrame: up to 12 weeks of clinical trial
measure: Change in blood concentrations of LH (luteinizing hormone)
timeFrame: up to 12 weeks of clinical trial
measure: Change in blood concentrations of FSH (follicle-stimulating hormone)
timeFrame: up to 12 weeks of clinical trial
measure: Change in blood concentration of testosterone
timeFrame: up to 12 weeks of clinical trial
measure: Change in blood concentration in androstenedione
timeFrame: up to 12 weeks of clinical trial
measure: Change in blood concentrations of SHBG (sex hormone-binding globulin)
timeFrame: up to 12 weeks of clinical trial
measure: Change in blood concentration of DHEAS (dehydroepiandrosterone sulfate)
timeFrame: up to 12 weeks of clinical trial
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
References:
Clinical trial NCT01421199: Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
Official title: A Prospective, Multi Center, Non-randomized Clinical Trial to Evaluate the Ear Effusion Detection and Characterization System (EEDCS) to Detect and Characterize Middle Ear Fluid in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Otitis Media With Effusion
Middle Ear Effusion
Keywords: Otitis Media with Effusion
Middle Ear Effusion
Lead sponsor: OtoSonics Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-22
Enrollment: 125
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study has three objectives:

1. To determine if the device can detect if middle ear fluid is present in children who are scheduled for tube placement (myringotomy)
2. If fluid is present to characterize the fluid as thick or thin
3. Evaluate the safety of the device


Eligibility criteria: Inclusion Criteria:

* 6 months to 17 years
* scheduled to undergo myringotomy procedure

Exclusion Criteria:

* mastoiditis
* tympanostomy tubes
* chronic middle ear disease
* otitis externa
* perforations of the middle ear
* use of antibiotic ear drops within 2 days of surgery
* systemic antibiotic use

Primary outcomes:
measure: detection of middle ear fluid
timeFrame: day one
Secondary outcomes:
measure: fluid viscosity
timeFrame: day one
Other outcomes:
Locations:
Study officials:
affiliation: Madigan Army Medical Center
name: Mark E Boseley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02051699: One-Leg Standing Radiograph: A Novel Technique to Evaluate the Severity of OA Knee
Official title: One-Leg Standing Radiograph: A Novel Technique to Evaluate the Severity of Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severity of OA Knee
Difference of Joint Space Width Between One-leg and Both-leg Standing Radiograph
Keywords: Osteoarthritis of the knee
Weight bearing radiograph
Kellgren-Lawrence classification
Joint space width
One-leg standing view
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients who came to our clinic which bilateral knee pain

Brief summary: The purpose of this study is assess the severity of osteoarthritic knee between one-leg and both-leg standing radiograph in primary OA knee

Detailed description: All patients were performed digital radiographs which one-leg and both-leg standing anteroposterior view. Medial and lateral joint space width were measured. The severity of OA knee was identified by the Kellgren-Lawrence (KL) classification.

Eligibility criteria: Inclusion Criteria:

* Bilateral knee pain more than 3 months

Exclusion Criteria:

* Inflammatory OA knee
* previous knee injury
* previous knee infection
* previous knee surgery
* pregnant women
* unable to bear weight on one leg

Primary outcomes:
measure: Change of joint space with between one-leg standing and both-leg standing radiographs in OA knee patients
timeFrame: one day
Secondary outcomes:
measure: Change of radiographic grading between one-leg and both-leg standing AP views in OA knee patients
timeFrame: one day
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: department of orthopaedic surgery, Faculty of medicine, Thammasat university
state: Pathumthani
Study officials:
affiliation: orthopaedic department
name: supakit kanitnate, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05388799: The Effect of Brochure-Based Education on Patients Planned for Nose Surgery
Official title: The Effect of Brochure-Based Education on Surgical Fear and Anxiety in Patients Planned for Nose Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was planned as a randomized controlled trial to determine the effect of brochure-based education on fear and anxiety in patients scheduled for nose surgery.It is planned to collect research data in Hatay Mustafa Kemal University Hospital otorhinolaryngology clinic between June 2022 and June 2023.The population of the research will be the patients who are hospitalized in the otorhinolaryngology clinic of the aforementioned hospital and are planned for nasal surgery. The sample of the study, on the other hand, will consist of 52 patients who meet the inclusion criteria and agree to participate in the study verbally and in writing.The data of the study were collected by using the Personal Information Form, the Surgical Fear Scale and the Surgical Anxiety Scale, which were prepared in line with the literature.The data will be analyzed with the SPSS package program.


Eligibility criteria: Inclusion Criteria:

* 18 years and over, 65 years and under,
* Being literate,
* To be able to understand and speak Turkish
* First time nose surgery,
* Agreeing to participate in the research.

Exclusion Criteria:

* Having any psychiatric disorder that may reduce the ability to comprehend and understand
* The surgery was canceled for some reason.

Primary outcomes:
measure: The effect of preoperative care on surgical fear in patients scheduled for nasal surgery
timeFrame: six months
measure: The effect of preoperative care on surgical anxiety in patients scheduled for nasal surgery
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Hatay Mustafa Kemal University Institute of Health Sciences
Study officials:
References:
Clinical trial NCT05756699: Evaluation of Proteome Multimarker Panel With Multiple Reaction Monitoring as a Surveillance for Hepatocellular Carcinoma
Official title: A Prospective Study Evaluating the Accuracy of Proteome Multimarker Panel With Multiple Reaction Monitoring vs. Ultrasonography and Serum AFP as a Surveillance for Hepatocellular Carcinoma in High-Risk Population
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Liver Cirrhosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University
First posted: 2023-03-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with liver cirrhosis who receive regular surveillance for hepatocellular carcinoma.

Brief summary: Most current guidelines recommend hepatocellular carcinoma (HCC) surveillance with ultrasound and alpha feto-protein (AFP) every 6 months for individuals with risk factors. However, the sensitivity of ultrasound for HCC detection is significantly reduced, especially in high-risk cirrhotic patients. In this study, the investigators aim to evaluate the efficacy of multiple reaction monitoring (MRM)-based multimarker panel as a surveillance tool for HCC. During two surveillance periods (starting from the time of voluntary consent and 6 months later), participants receive ultrasound, AFP, and MRM-based multimarker panel analysis. Patients who are suspected of HCC based on one of three tests undergo a contrast-enhanced CT scan within 6 weeks. After 6 months from the second surveillance period, the investigators re-evaluate the development of HCC using contrast-enhanced CT and AFP. The diagnostic accuracy of MRM-based multimarker panel is compared to ultrasound and AFP.


Eligibility criteria: Inclusion Criteria:

* Patients with liver cirrhosis aged over 18 years, who receive regular surveillance for hepatocellular carcinoma.
* Patients with Risk Index greater than 2.33, corresponding to the annual 5% risk of hepatocellular carcinoma development.

  * Risk Index = 1.65 (if the prothrombin activity was ≤ 75%) + 1.41 (if the age was 55 years or older) + 0.92 (if the platelet count was \< 75 X103/mm3) + 0.74 (if the presence of anti-hepatitis C virus was positive).

Exclusion Criteria:

* History of malignancy diagnosis including hepatocellular carcinoma
* Impaired renal function (Estimated glomerular filtration rate \<30 mL/min/1.73m2)
* Impaired hepatic function (Child-Pugh class C)
* Patients who are not eligible for voluntary consent

Primary outcomes:
measure: HCC detection rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Early HCC detection rate
timeFrame: Up to 2 years
measure: False referral rate
timeFrame: Up to 2 years
measure: Positive predictive value
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06167499: Therapeutic Education Consultations With Diabetic Patients Treated With Intensified Insulin Therapy
Official title: Impact of Therapeutic Education Consultations Conducted by Specialized Nurses on Glycemic Control and Quality of Life in Diabetic Patients Treated With Intensified Insulin Therapy: a Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabete Mellitus
Insulin Dependent Diabetes
Lead sponsor: Hopital Nord Franche-Comte
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Diabetes is a chronic condition that affects around 8% of the French population, and is associated with severe complications. Maintaining a constant blood glucose level of between 0.7 and 1.80 g/l is the day-to-day objective of diabetic patients.Insulin can be administered by injection via syringes or pens, or by insulin pumps and patients can perform self-monitoring of blood glucose.

All these actions can be the subject of therapeutic education, which involves a range of tools, including dedicated individual consultations carried out by state-qualified nurses.

The aim of the study is to evaluate the benefit of therapeutic education consultations conducted by nurses in addition to medical consultations, on the follow-up of diabetic patients, insulin pump carriers or treated with multiple injections, in terms of glycemic control, quality of life and medical complications. The objective of the study is to evaluate whether the therapeutic education consultations conducted by nurses can improve the care of the diabetic patient.


Eligibility criteria: Inclusion Criteria:

* Woman or man aged 18 to 75
* Diabetic patient type 1 or 2 insulin-dependent
* Patient treated with multi-injections or insulin pump
* Patient equipped with FreeStyle Libre flash glucose monitoring system
* Glycemic imbalance with HBA1c \> 8
* Patient living at home

Exclusion Criteria:

* Recent discovery (\< 6 months) of diabetes
* Major intellectual disability
* Social isolation
* IMC \> 35
* Pregnant women

Primary outcomes:
measure: Rate of glycated hemoglobin HBA1c
timeFrame: 12 months
Secondary outcomes:
measure: Evaluation of glycemic control over 18 months
timeFrame: 18 months
measure: Evaluation of patients' quality of life over 18 months
timeFrame: 18 months
measure: Evaluation of patients' satisfaction with diabetes treatment
timeFrame: 18 months
measure: Evaluation of long-term complications over 18 months
timeFrame: 18 months
Other outcomes:
Locations:
city: Trévenans
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
affiliation: Hopital Nord Franche-Comte
name: Elena BOUCHEZ
role: PRINCIPAL_INVESTIGATOR
References: