louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00822003: Effects of Oral GLP-1 on Glucose Homeostasis and Appetite Profile in Healthy Male Subjects
Official title: Effects of Oral GLP-1 on Glucose Homeostasis and Appetite Profile Following an Oral Glucose Tolerance Test in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glucose Homeostasis
Keywords: GLP-1
insulin
glucose
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2009-01-14
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators aimed to investigate the pharmacokinetic and pharmacodynamic effects of a single dose (2 mg) of oral GLP-1 administered prior to an oral glucose tolerance test (oGTT) in 16 healthy males

Detailed description: Background: Glucagon like peptide-1 (GLP-1) promotes satiety and reduces food intake. GLP-1 is secreted from intestinal L-cells into the splanchnic circulation, it is (i) subject to rapid breakdown and (ii) submitted to a high liver extraction. Highest concentrations of GLP-1 are therefore found in the splanchnic blood rather than in the systemic circulation. An oral delivery system would mimick the physiological path of endogenous secretion. Objective: We aimed to investigate the pharmacokinetic and pharmacodynamic effects of a single dose (2 mg) of oral GLP-1 administered prior to an oral glucose tolerance test (oGTT) in 16 healthy males.

Eligibility criteria: Inclusion Criteria:

* healthy male subjects
* no gastrointestinal or endocrine disorder

Exclusion Criteria:

* females
* alcohol or drug abuse
* active virus hepatitis

Primary outcomes:
Secondary outcomes:
measure: Glucagon secretion GH release adverse events
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clinical Research Center, University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: Clinical Research Center, University Hospital Basel
name: Christoph Beglinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01626703: Effect of Depressin Screening and Care Program at Community Health Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Screening
Elderly
Lead sponsor: National Clinical Research Coordination Center, Seoul, Korea
Sponsor class: OTHER_GOV
First posted: 2012-06-25
Enrollment: 86
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Depression affect between 5% and 10% of older adults seen in the primary care setting.Late-life depression is often chronic or recurrent and is associated with substantial suffering, functional impairment, and diminished health-related quality of life.Depressed, older primary care patients are frequent users of general medical services and may have poor adherence to medical treatments.They are also at increased risk of death from suicide and medical illnesses. The aim of this study is to examine whether depression screening and health care practitioner feedback are increased depression treatment rate.

Depression screening is provided 60 or more who visited community health care center with a 15-item Geriatric Depression Scale.GDS scores of 10 or more were classified depression positive. Intervention group participants received twice remind calls from primary care nurse.


Eligibility criteria: Inclusion Criteria:

* 60 or more
* 10 or more in GDS scor

Exclusion Criteria:

* severe cognitive problem

Primary outcomes:
measure: Reuptake rate
timeFrame: 12 weeks
Secondary outcomes:
measure: reduced depressive symptoms
timeFrame: 12 weeks
measure: changed perceived heath status
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chungju
country: Korea, Republic of
facility: Chungju community health care center
state: Choongbuk
Study officials:
References:
Clinical trial NCT01867203: Functional and Clinical Impact of CYP3A Genetic Polymorphisms on Statin Therapy
Official title: Lipid-lowering Therapy Individualization
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Patients With High Cholesterol Levels Needing a Lipid-lowering Therapy
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2013-06-03
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with statin drugs

Brief summary: Patients needing lipid lowering therapy will be recruited before initiation of the treatment. For each patient, total and LDL cholesterol levels before start of therapy will be measured. One, three and six months after his/her first visit, when steady-state will be reached, for each included patient, the cholesterol levels will be re-assessed in order to evaluate the response to statin therapy calculated as the amplitude of cholesterol reduction. The aim is to assess the association between patient's genotype and the response to statin therapy.


Eligibility criteria: Inclusion Criteria:

* Patient known to be compliant
* Age \[25-80\]
* treated with Atorvastatin, simvastatin, fluvastatin.

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Cholesterol levels-side effects
timeFrame: 1 to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Saint-Luc Hospital
Study officials:
References:
Clinical trial NCT02279303: Rx for Better Breast Health
Official title: Prescription for Better Breast Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
First posted: 2014-10-31
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This randomized controlled trial will test the impact of a patient-navigated, anti-inflammatory, culinary-based intervention (reinforced by motivational interviewing \[MI\] and tailored newsletters) on obese (body mass index \[BMI\] 30+), early-stage (0-IIIA) breast cancer survivors compared to a control group.

Detailed description: The investigators will recruit English-speaking, early-stage breast cancer survivors (N=200) to a two-arm randomized controlled trial (RCT) involving a 2 (group) by 3 (time) repeated measures design. The intervention will stimulate dietary behavior changes using individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change. Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments. Groups will be compared at baseline and 6- and 12-month follow-up. Dependent measures will include dietary behavior and levels of cancer-associated biomarkers.

Eligibility criteria: Inclusion Criteria:

* Females 18 years or older
* Primary diagnosis of breast cancer
* Fluency in English
* B.M.I. \>= 30
* Available for follow-up for 12 months

Exclusion Criteria:

* Clinical evidence of metastatic disease
* Not diagnosed with primary breast cancer
* Lack fluency in English
* B.M.I. \< 30

Primary outcomes:
measure: Achieve USDA-recommended dietary intake based on five major food groups
timeFrame: 12 months
measure: Intervention versus Control group comparison of circulating Adipose Stromal Cells (ASCs) at follow-up
timeFrame: 12 months
measure: Comparison of Interleukin (IL) pro-inflammatory biomarkers
timeFrame: 12 months
measure: Comparison of Interleukin (IL) anti-inflammatory biomarkers
timeFrame: 12 months
measure: Comparison of C-Reactive Protein (CRP)
timeFrame: 12 months
measure: Comparison of Tumor Necrosis Factor-alpha (TNF-alpha)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Amelie Ramirez, DRPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02661503: HD21 for Advanced Stages
Official title: HD21 for Advanced Stages Treatment Optimization Trial in the First-line Treatment of Advanced Stage Hodgkin Lymphoma; Comparison of 6 Cycles of Escalated BEACOPP With 6 Cycles of BrECADD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Classical Hodgkin Lymphoma
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2016-01-22
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective of the trial is to demonstrate non-inferior efficacy of six cycles of BrECADD compared to six cycles of escalated BEACOPP, each followed by radiotherapy to PET-positive residual lesions ≥2.5 cm, in terms of progression free survival (efficacy objective).

If non-inferior efficacy can be shown, the co-primary objective is to further demonstrate reduced toxicity of the BrECADD treatment compared to the escalated BEACOPP treatment measured by treatment related morbidity (TRMorbidity objective).


Eligibility criteria: Inclusion Criteria:

* Histologically proven classical Hodgkin lymphoma
* First diagnosis, no previous treatment, 18 to 60 years of age
* Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV

Exclusion Criteria:

* Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma
* Previous malignancy (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
* Prior chemotherapy or radiotherapy

Primary outcomes:
measure: Progression Free Survival
timeFrame: 5 years
measure: Treatment Related Morbidity
timeFrame: during 6 cycles of chemotherapy (21-day cycles)
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
Study officials:
affiliation: University of Cologne, I. Dept. of Medicine
name: Peter Borchmann, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005503: Epidemiology of Cardiac Development in Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: To document normal developmental changes in cardiac structure and function during late childhood and adolescence.

Detailed description: DESIGN NARRATIVE:

The investigators documented the nature and extent of changes in cardiac structure based on M-mode measurements and developed corresponding reference values. They documented the nature and extent of changes in cardiac function based on pulse Doppler measures and indices and developed corresponding reference values. They also investigated clinical findings based on M-mode and Doppler measurements as well as changes in body size and composition, sexual maturation, and other covariates. They used existing data from Project HeartBeat! 's 12 four-monthly examinations over the age range from 8 to 17 years.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Darwin Labarthe
References:
Clinical trial NCT02205203: Youth Mayo Clinic Anxiety Coach Randomized Controlled Trial
Official title: Expanding Access to Therapy for Childhood Anxiety Disorders Via Smart Phones - RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Social Anxiety
Social Phobia
Separation Anxiety
Generalized Anxiety
GAD
Phobia
Panic
Agoraphobia
Obsessive Compulsive Disorder
OCD
Child
Adolescent
Smartphone
Teen
Youth
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-07-31
Enrollment: 145
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study aims to test the feasibility and effectiveness of using the Mayo Clinic Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of anxiety disorders in youth, particularly those youth who may have limited access to mental health treatment in the traditional clinical setting.

Detailed description: 60 therapists in underserved areas will treat children with anxiety disorders in one of three conditions (treatment as usual, Anxiety Coach with face-to-face therapy, or Anxiety Coach with minimal direct contact) to determine the feasibility of using of Anxiety Coach to increase the frequency of exposure and improve outcomes with varying degrees of face-to-face contact (N = 60 patients).

Eligibility criteria: Inclusion Criteria:

1. Age 7 to 17
2. Primary diagnosis of:

   1. social phobia,
   2. separation anxiety disorder,
   3. panic disorder with and without agoraphobia,
   4. specific phobia, or
   5. obsessive compulsive disorder
3. A parent or other primary care giver available to participate with the child in all assessment and treatment activities
4. Estimated average intelligence
5. English speaking

Exclusion Criteria:

1. History of and/or current diagnosis of:

   1. psychosis,
   2. autism,
   3. bipolar disorder,
   4. mental retardation,
   5. oppositional defiant disorder,
   6. PTSD,
   7. selective mutism, or
   8. major depressive disorder
2. Current suicidality or recent suicidal behavior
3. Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties
4. Starting or changing the dosage of a psychiatric medication in the last two months

Primary outcomes:
measure: Mean change from Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion
timeFrame: Within 5 working days of Treatment Completion
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Stephen Whiteside, Ph.D., L.P.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002003: Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas
Official title: Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin
HIV Infections
Keywords: Mitoxantrone
Lymphoma, Large-Cell
Etoposide
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the efficacy and toxicity of the combination of mitoxantrone hydrochloride ( Novantrone ) and etoposide in the treatment of patients with HIV associated lymphomas.


Eligibility criteria: Inclusion Criteria

Patients must have the following:

* Positive HIV antibody, positive HIV culture or antigen capture, or prior diagnosis of AIDS by the CDC criteria.
* Diagnosis by pathological examination of large cell or immunoblastic lymphoma within measurable or evaluable disease.
* Pneumocystis carinii pneumonia (PCP) prophylaxis during the course of the study.
* Signed written informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks.
* Stage IE Central Nervous System lymphomas.

Patients with the following are excluded:

* More than one previous treatment for lymphoma.
* Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks.
* Conditions that preclude obtaining an informed consent.
* Not accessible for scheduled treatment visits or follow-up.
* Stage IE Central Nervous System (CNS) lymphomas.

Prior Medication:

Excluded within 2 weeks of study entry:

* Zidovudine.
* Excluded:
* Doxorubicin dosing = or \> 300 mg/m2.

Prior Treatment:

Excluded:

* Received more than one previous treatment regimen for lymphoma.

Required:

* Prophylactic treatment for Pneumocystis carinii pneumonia (PCP) prophylaxis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: UMDNJ - New Jersy Med School
state: New Jersey
city: New York
country: United States
facility: New York Univ Med Ctr
state: New York
city: New York
country: United States
facility: Saint Luke's - Roosevelt Hosp Ctr
state: New York
Study officials:
References:
Clinical trial NCT06448403: Multimodal Assesment of Alzheimer Patients
Official title: Multimodal Assessment of Cognitive Impairment in Alzheimer Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mild Cognitive Impairment
Alzheimer Disease, Late Onset
Cognitive Impairment
Dementia
Keywords: Alzheimer Disease (AD)
Mild cognitive impairment (MCI)
Brain Diseases
Nervous System Disorders
Neurodegenerative Diseases
Dementia
Cognitive impairment
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is from Tronderlag in Norway, mainly in and around Trondheim city.

Brief summary: The goal of this study is to learn more about the changes in the brains of patients with cognitive impairment (MCI) and Alzheimer's Disease (AD).

The main questions the study aims to answer are:

1. What findings can be used to earlier detect patients that will develop Alzheimers?
2. Which differences are seen between healthy and cognitively impaired patients?
3. Which differences are seen between patients with Alzheimers disease?

Participants will undergo:

* Cognitive tests
* Magnetic resonance imaging (MRI)
* Electroencephalography (EEG)
* Blood sample collection
* Fecal sample collection
* A randomized group will undergo polysomnography analysis.

Detailed description: The projects aims to map brain changes in patients with mild cognitive impairment (MCI) and Alzheimer's Disease (AD) by combining different assesment modalities.

In the MRI, researchers will get the opportunity to analyse both structural and functional brain changes. In the EEG, changes in elctrical activites will be measured. The blood samples allow researchers to analyse specific dementia and inflammation proteins, while fecal speciments can be used to assess bacterial composition. Additionally, the cognitive testing allow to assess the specific part of cognitive function which is affected.

Eligibility criteria: Inclusion Criteria:

* MCI and AD according to relevant ICD-criterias.
* Control cohort is age and gender matched with other cohorts.

Exclusion Criteria:

* Uneligibility for any of the planned neuroimagery devices (MRI, EEG)
* AD diagnosis before the age of 65 (Early-onset AD).
* Brain tumor
* Traumtic head injury
* Earlier neurosurgery
* Other neyrodegenerative diseases (i.e Parkinson and ALS)
* Diseases related to inflammation and auto-immunity (i.e MS)

Primary outcomes:
measure: MCI-AD converters
timeFrame: 5 years
measure: AD-subclassification
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian University of Science and Technology (NTNU) & St. Olavs Hospital, Trondheim University Hospital
name: Axel Sandvig, Prof., MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06036303: Nasr Fascial Closure: A Novel Device for Fascial Closure in Laparoscopic Surgery
Official title: Nasr Fascial Closure: A Novel Device for Fascial Closure in Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholecystolithiasis
Keywords: Laparoscopic removal
Lead sponsor: ClinAmygate
Sponsor class: OTHER
Collaborators: name: Aswan University Hospital
First posted: 2023-09-13
Enrollment: 160
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 study will investigate the efficacy and safety of a new fascial closure device "Nasr Fascial Closure Device" compared to the Karl Storz Berci Fascial Closure Device 26173AM.


Eligibility criteria: Inclusion Criteria:

* age \> 18
* eligible for Laparoscopic cholecystectomy

Exclusion Criteria:

* refused to participate

Primary outcomes:
measure: duration of port site closure
timeFrame: 1 day
measure: Rate of failure of port site
timeFrame: 1 day
Secondary outcomes:
measure: Incidence of port site infection
timeFrame: 1 month
measure: Incidence of port site hernia
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan University Hospital
name: Mohie El-Din M Madany
role: PRINCIPAL_INVESTIGATOR
References: