louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00243672: Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques
Official title: Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques: a Randomised Microarray-Study on Endarterectomy Specimens of Human Carotid Arteries
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Atherosclerosis
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2005-10-24
Enrollment: 100
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: Rupture of unstable atherosclerotic plaques is the underlying pathophysiologic mechanism of acute coronary syndromes and thus also of perioperative myocardial ischemia. Lipid lowering drugs such as statins and fibrates have been shown to improve the outcomes of patients with atherosclerosis. This is not only mediated through their therapeutic actions on lipid metabolism, but relies on a multitude of pleiotropic effects of these substances. One of the most interesting of these effects is the stabilisation of atherosclerotic plaques.

To investigate these effects in a perioperative setting, patients scheduled for thromboendarterectomy of the carotid artery will be recruited. They will be randomised to receive either atorvastatin 10mg/d, gemfibrozil 1200mg/d or placebo for two weeks preoperatively. Specimens of carotid plaques will be obtained intraoperatively. After microscopic characterisation of plaques, DNA-microarray analyses will be done to gain insights into the transcriptional regulation and expression profiles of various types of atherosclerotic plaques under different pharmacological circumstances (stable or unstable with statin/fibrate/placebo).


Eligibility criteria: Inclusion Criteria:

* atherosclerosis
* stenosis of carotid artery

Exclusion Criteria:

* therapy with statine or fibrate
* pregnancy

Primary outcomes:
measure: expression profile in atherosclerotic plaque
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology and Intensive Care, University Hospital Münster
name: Gregor Theilmeier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004572: Identification and Therapy Efficacy of Type 2 Diabetes in Hispanic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Type 2 Diabetes
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-02-17
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION

Brief summary: The two major types of diabetes are type 1 and type 2 diabetes. Although most patients with type 2 diabetes are older than age 40, type 2 diabetes has been reported with increasing frequency among patients under the age of 20. This form of diabetes has been called type 2 diabetes of youth, abbreviated type 2Y. Little is known about the etiology of type 2Y; however, clinicians believe that it occurs most commonly in obese children of particular ethnic groups. A positive family history appears to be one major risk factor for developing type 2Y diabetes. The individual contribution of ethnicity, obesity, and genetics to type 2Y have yet to be elucidated. There is no consensus regarding treatment with type 2Y diabetes. Observation of our Hispanic patients in the Houston area reveals a large number with type 2Y. The major purpose of this study is to examine the genetic and environmental risk factors such as family history, ethnicity, and obesity in Hispanic children with type 2Y diabetes. SPECIFIC AIMS: 1) To examine the genetic and environmental risk factors and clinical signs associated with type 1 diabetes and type 2 diabetes of youth. 2) To compare the efficacy of the treatment modalities, insulin and oral agents, in type 2Y patients. METHODS: We will undertake a retrospective case study, to include a review of hypothesized risk factors in all the medical records of pediatric diabetes patients seen at University of Texas. We anticipate that approximately 200 patients with type 1 diabetes and 30 patients with type 2Y diabetes will be identified. A Sustacal challenge test will be done in patients with a suspected diagnosis of type 2Y in order to confirm the clinical diagnosis. Parents will be contacted by phone for a detailed pedigree intake. Type 1 and type 2Y patients will be compared for each of the studied features. A retrospective review of diabetes type 2 therapies used in type 2Y patients will be undertaken through further examination of the medical records in order to compare insulin treatment to oral agents. We will also test a subset of the patients for the gene identified in adult Hispanics with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Approximately 30 pediatric patients (ages 10-18) believed to have a diagnosis of type 2Y. Each subject must have been diagnosed for at least one year.

Exclusion Criteria:

* Patients over the age of 18 or under the age of 10
* Patients in whom intellectual functioning is impaired sufficiently to interfere with the understanding of the protocol.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02855372: Impact of the Age Difference Between the Donor and Recipient on the Morbidity and Mortality After Lung Transplantation. Study on a National Multicenter Cohort (COLT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Transplantation
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient who underwent a lung transplantation

Brief summary: It is commonly accepted that the characteristics of the organ donor impact on the future post transplant. In lung transplantation (LP), the defining characteristics of the "ideal" donor includes an age less than 55 years. However, before the pulmonary graft shortage with a corresponding mortality still too high waiting list, the lung graft acceptance criteria were reassessed permitting criteria "extension" ( "marginal" graft). And were grafted, depending on the urgency and accessibility problems in the registry of potential candidate, organs from donors aged 55 and older with quite comparable to those obtained from younger donors . Nevertheless, it is common practice that the grafts from older donors are more readily allocated to older candidates and the most severe, as many confounding factors to assess the real impact of donor age on post-transplant evolution on small cohorts.

The main goal of this study is to compare the survival of lung transplant patients depending on the age difference between donor and recipient.

The study will be conducted from a broad national cohort of lung transplant patients registered in COLT ( Lung Transplantation COhort). Established in September 2009, promoted by the University Hospital of Nantes, COLT involves 11 lung transplant centers authorized on French territory. It provides a standardized common longitudinal monitoring of the recipient from his transplant. Currently more than 1,000 patients included in this study are transplanted.


Eligibility criteria: Inclusion Criteria:

* Male or female adult patients, included in COLT cohort, thus having given a signed written consent
* Who received a lung transplant

Exclusion Criteria:

* Lung transplanted patients in a context of national priority
* Lung transplanted patients who died within 3 months after the surgery
* Patients for whom it is a second lung transplantation

Primary outcomes:
measure: Age difference in years between donor and recipient
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille Cedex 01
country: France
facility: Assistance Publique Hôpitaux de Marseille, Hôpital Nord
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Catherine GEINDRE
role: STUDY_DIRECTOR
References:
Clinical trial NCT01507272: Safety and Tolerability of Liraglutide in Healthy Male Volunteers
Official title: A Randomised, Double-blind, Placebo-controlled, Dose Escalation Trial of Single Doses of NNC90-1170 to Assess Tolerability, Pharmacokinetics, Pharmacodynamics and Absolute Bioavailability in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-10
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to assess the safety and tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170 (liraglutide).


Eligibility criteria: Inclusion Criteria:

* Male subjects of any ethnic origin
* Written informed consent obtained. (The subject must give signed informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject)
* Good general health based on medical history, physical and laboratory examinations, incl. ECG (electrocardiogram)
* Body mass index within the range 20-27 kg/m\^2, inclusive

Exclusion Criteria:

* Any clinically significant abnormal laboratory test results or clinically significant abnormal ECG
* History of alcoholism or drug addiction; positive results in the plasma urine screens for illicit drug
* Alcohol intake within 48 hours of visit
* Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies
* History of significant drug allergy or drug hypersensitivity
* Smoke 5 cigarettes or more, or the equivalent per day and is unable to refrain from smoking during the 3 days prior to the dosing day and during the confinement period
* Subjects who drink more than 8 cups of tea/coffee per day

Primary outcomes:
measure: AUC (area under the curve)
Secondary outcomes:
measure: Cmax, maximum concentration
measure: tmax, time to maximum concentration
measure: t½, terminal half-life
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Elbrond B, Jakobsen G, Larsen S, Agerso H, Jensen LB, Rolan P, Sturis J, Hatorp V, Zdravkovic M. Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male subjects. Diabetes Care. 2002 Aug;25(8):1398-404. doi: 10.2337/diacare.25.8.1398.
citation: Agerso H, Vicini P. Pharmacodynamics of NN2211, a novel long acting GLP-1 derivative. Eur J Pharm Sci. 2003 Jun;19(2-3):141-50. doi: 10.1016/s0928-0987(03)00073-3.
Clinical trial NCT05338372: Effects of Forest Therapy on Physical and Psychological Parameters in the General Population
Official title: Forest Therapy on Physical and Psychological Parameters in the General Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Population
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In recent years, nature and forest therapy has increasingly become the focus of medical research. Recent scientific findings indicate overall positive effects of nature and forest therapy on physical and mental health. In Asia and Australia, it has already been implemented as a public health concept of prevention and health promotion. The aim of the project is to replicate the experience gained in Asia over the last three decades on the physical and psychological effects of nature/forest therapy in the context of the German forest and to investigate it further scientifically.


Eligibility criteria: Inclusion criteria:

* Women and men aged 18 to 90 years.
* Capacity to consent

Exclusion criteria:

* Serious acute or chronic medical conditions
* Immobility or limitation of mobility due to orthopedic, neurological or other medical causes
* Participation in another study
* Serious mental illness
* Pregnancy and lactation

Primary outcomes:
measure: Profile of Mood States (POMS)
timeFrame: Change from baseline POMS score at 3 days
Secondary outcomes:
measure: Perceived Benefits of Nature Questionnaire (PBNQ)
timeFrame: Change from baseline PBNQ score at 3 days
measure: Subjective Vitality Scale state (SVS-G state)
timeFrame: Change from baseline SVS-G score at 3 days
measure: Complaint List (B-LR)
timeFrame: Change from baseline B-LR score at 3 days
measure: Perceive Stress Questionaire (PSQ)
timeFrame: Change from baseline PSQ score at 3 days
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Change from baseline STAI score at 3 days
measure: PROMIS Scale v1.2 - Global Health
timeFrame: Change from baseline PROMIS score at 3 days
measure: Allgemeine Selbstwirksamkeit Kurzskala (ASKU)
timeFrame: Change from baseline ASKU score at 3 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University
Study officials:
References:
Clinical trial NCT03280472: Transition to College/Miami University
Official title: Transition to College/Miami University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interpretation Bias Modification
Symptom Tracking
Keywords: Interpretation Bias
Interpretation Modification Program
Lead sponsor: Miami University
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current project will test whether a computerized training program, Cognitive Bias Modification (CBM), can be used as a prevention inoculation tool to reduce vulnerability to anxiety among incoming college students. Those not in the CBM condition will complete a symptom tracking condition (ST). We will also test whether ST influences vulnerability to anxiety among incoming college students.


Eligibility criteria: Inclusion Criteria:

* First and Second year students
* Entered college in fall of 2017
* Fluent in English
* LSAS-SR score greater than or equal to 14 and less than or equal to 74.

Primary outcomes:
measure: Change in Student Adjustment to College Questionnaire
timeFrame: Participants report on their past few days. The SACQ is administered at T1-T5. T2 occurs within ~1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.
Secondary outcomes:
measure: Change in Interpretations
timeFrame: Participants report interpretations to a variety of situations. The IQ is administered at T1 and T4. T2 occurs within 1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.
measure: Change in Liebowitz Social Anxiety Scale-Self-Report
timeFrame: Participants report on symptoms during the past week. The LSAS-SR is administered at T1-T5. T2 occurs within ~1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.
Other outcomes:
Locations:
city: Oxford
country: United States
facility: Anxiety Cognition and Emotion Laboratory
state: Ohio
Study officials:
affiliation: Miami University
name: Elise Clerkin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05140772: Glutamine Effects in Burn Patients
Official title: Evaluations the Effect of Parenteral Glutamine on Reducing Infection Morbidity in Burn Patients in ICU. A Randomized Controlled Double-blind Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Drug Effect
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate the effect of parenteral glutamine supplementation on infection in burn patients.

Detailed description: Despite improvements in prevention and management, burn injury continues to represent a major threat to the health and welfare of people worldwide in all age groups. Even with early surgical intervention and aggressive antibiotic therapy, infectious complications are a major cause of death in severe burn injury, accounting for 75% of all deaths occurring after initial resuscitation.

It is proposed that one source of these infections is a translocation of gram-negative bacteria from the gut. However, this mechanism of bacterial translocation through the gut wall remains a controversial mechanism of infection in humans. In animal studies, it has been demonstrated that glutamine supplementation can decrease gut-derived bacterial translocation and improve outcomes from burn injury.

Whether this holds true in humans has to be evaluated by additional studies. A recent study concluded that glutamine supplementation reduces gram-negative bacteremia in burned patients but viewed itself as preliminary and suggested that more clinical trials are warranted to corroborate the study outcome.

Eligibility criteria: Inclusion Criteria:

* Age between 18-50 years.
* Total burn surface area of 20% - 60%.
* Expected length of stay in ICU \> 48 hr.
* Admission within 72 hrs of burn injury.
* Any thermal injury such as flame burns. Scald burns and contact burns.

Exclusion Criteria:

* Burn patients with hepatic failure.
* Burn patient with Severe renal failure (glomerular filtration rate (eGFR \<50 ml/min).
* Patients with inborn errors of amino-acid metabolism (e.g., phenylketonuria).
* Burn patients with pre-existing severe cardiac, pulmonary diseases.
* Burn patients with diabetes mellitus or cancer.
* Patients with metabolic acidosis (pH\<7.35).
* Electric burns.

Primary outcomes:
measure: wound culture test
timeFrame: on 1,5,10 and 15 days after ICU admission
Secondary outcomes:
measure: Procalcitonin level
timeFrame: on 1,5,10 and 15 days after ICU admission
measure: CRP
timeFrame: on 1,5,10 and 15 days after ICU admission
Other outcomes:
Locations:
city: Shibeen Elkoom
country: Egypt
facility: Ashraf Magdy Eskandr
Study officials:
References:
Clinical trial NCT05322772: A Study of Cardiac Arrhythmia and ECG Changes in Children With Convulsions at Sohag University Hospital
Official title: A Study of Cardiac Arrhythmia and ECG Changes in Children With Convulsions at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Convulsions
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children aged from 1month to 18 years presenting to the Pediatric Emergency with convulsions will be included.

Brief summary: Convulsion is a common pediatric disorder and there is strong relation between convulsion and cardiovascular system which revealed by ECG monitoring and there are many ECG abnormalities attributed to different causes of convulsions, A 12-lead ECG is a low-cost test and can detect clinically significant abnormalities such as long QTc interval or heart block. Doing an ECG in all patients presenting with seizures clinic, inevitably, pick up non-specific abnormalities which require further investigation. Moreover, a normal 12-lead ECG does not exclude a cardiovascular cause for collapse and for those in whom a cardiac cause is still suspected despite a normal ECG, referral to a cardiologist is advisable


Eligibility criteria: Inclusion Criteria:

* All children aged from 1month to 18 years presenting to the Pediatric Emergency with convulsions will be included.

Exclusion Criteria:

* Children not filling the criteria of convulsions (like conditions mimic epilepsy)
* Children with known cardiac disease or cardiac arrhythmia and patients who will not give consent will be excluded.

Primary outcomes:
measure: heart rate
timeFrame: one year
Secondary outcomes:
measure: PR interval
timeFrame: one year
Other outcomes:
measure: QTC
timeFrame: one year
Locations:
Study officials:
References:
citation: Huang X, Malek N, Simpson J, Kalladka D, Dunn FG, Leach JP. Winning hearts and minds: ECG reporting in the first seizure clinic. BMC Cardiovasc Disord. 2021 Jul 31;21(1):364. doi: 10.1186/s12872-021-02174-4.
citation: Rijnbeek PR, Witsenburg M, Szatmari A, Hess J, Kors JA. PEDMEANS: a computer program for the interpretation of pediatric electrocardiograms. J Electrocardiol. 2001;34 Suppl:85-91. doi: 10.1054/jelc.2001.28835.
citation: Karjalainen J, Viitasalo M. Fever and cardiac rhythm. Arch Intern Med. 1986 Jun;146(6):1169-71.
Clinical trial NCT00633672: A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued
Official title: A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: NSAID Associated Gastric Ulcers
Keywords: NSAID
Nexium
esomeprazole
Gastric Ulcers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-12
Enrollment: 400
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.


Eligibility criteria: Inclusion Criteria:

1. A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
2. Other key inclusion criteria, as specified in the protocol.

Exclusion Criteria:

1. History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
3. Other conditions and criteria, as specified in the protocol.

Primary outcomes:
measure: To assess the safety and efficacy of esomeprazole 40 mg qd versus ranitidine 150 mg bid through 8 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy. Healing is defined as the absence of gastric ulcers.
Secondary outcomes:
measure: Patient and investigator assessed GI symptoms for up to 8 weeks of treatment.
timeFrame: Assessments at week 0, week 4 and week 8
measure: Safety and tolerability of the treatments for 8 weeks of treatment.
timeFrame: Assessments at week 0, week 4 and week 8
Other outcomes:
Locations:
Study officials:
affiliation: Nexium Global Product Director, AstraZeneca
name: Paula Fernstrom
role: STUDY_DIRECTOR
References: