louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01176357: Adiponectin and Inflammatory Mediators in Mediastinal Adipose Tissues
Official title: Adiponectin and Inflammatory Mediators in Mediastinal Adipose Tissues Between Patients With Coronary Artery Diseases and With Valvular Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Atherosclerosis
Keywords: Coronary artery disease (CAD)
atherosclerosis
mediastinal adipose tissue
adiponectin, inflammatory mediators
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2010-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with CAD or with valve diseases proposed to have cardiac operations

Brief summary: Coronary artery disease (CAD), the most common type of heart disease, is caused by hardening of the arteries, or atherosclerosis that is an inflammatory process in which immune mechanisms interact with metabolic risk factors to initiate, propagate, and activate lesions in the arterial trees. Epidemiological studies have found that increased cardiovascular risks are associated with increased levels of inflammatory cytokines (eg, interleukin-6 \[IL-6\] and tumor necrosis factor-alpha\[TNF-alpha\]) or their hepatic product, C-reactive protein (CRP). Higher expression of interleukin-Ibeta(IL-1beta),IL-6, monocyte chemotactic protein-1 (MCP-1), and TNF-alpha were observed in epicardial adipose tissues in patients with CAD. These findings suggested that the pericoronary tissues could be a source of inflammatory mediators or act as paracrine that lead to vascular inflammation on CAD pathogenesis. However, adiponectin, a kind of adipocytokine, produced and secreted exclusively by adipose tissue, has been reported to have a variety of anti-inflammatory functions against atherosclerosis, resulting in risk reduction for incidence of CAD events. It remains unclear whether adiponectin and inflammatory mediators in mediastinal adipose tissue contribute to CAD. We therefore aim to analyze the expression of adiponectin and inflammatory mediators in mediastinal adipose tissue between patients with CAD and with valve diseases, and to correlate these parameters with clinical atherosclerotic risks, medications (statins or antiplatelet), and blood sugar.


Eligibility criteria: Inclusion Criteria:

* patient underwent CABG or valve surgery in our hospital will be included

Exclusion Criteria:

* liver disease
* dhronic renal insufficiency
* neoplastic diseases
* taking steroids
* congestive heart failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: FEMH
Study officials:
affiliation: FEMH
name: Kuan-Ming Chiu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00540657: A Phase II Study of CCX282-B in Patients With Celiac Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study Testing CCX282-B in the Treatment of Celiac Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Celiac Disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-10-08
Enrollment: 90
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: TREATMENT

Brief summary: The purpose of this study is to determine whether CCX282-B is effective in mitigating the effects of gluten ingestion in patients with celiac disease

Detailed description: Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Eligibility criteria: Key Inclusion Criteria:

* Male or female, between 18 and 75 years of age
* Established diagnosis of celiac disease
* Subject has been following a strict gluten-free diet for at least 24 months

Key Exclusion Criteria:

* History of any infection requiring intravenous antibiotics, a serious local infection, systemic infection, or gastrointestinal infection within 12 weeks of randomization
* Use of any immunosuppressants, TNF inhibitors, or natalizumab during the 12 weeks prior to study randomization
* Use of steroids during the 4 weeks prior to study randomization
* Receipt of an experimental treatment for any disease within 4 weeks prior to randomization
* Known IgE-mediated atopy or allergy or anaphylactic reactions to gluten
* The subject suffers from a condition that carries a risk at endoscopy or is on anticoagulant treatment

Primary outcomes:
measure: Evaluation of the effect of CCX282-B compared to placebo on the villous height/crypt depth ratio of small intestinal biopsy specimens taken from subjects with celiac disease, before and after gluten exposure.
Secondary outcomes:
measure: Evaluation of CCX282-B compared to placebo on small intestinal mucosal inflammation before and after gluten exposure
measure: Evaluation of CCX282-B compared to placebo on gluten-induced celiac-type serology before and after gluten exposure
measure: Evaluation of CCX282-B compared to placebo on symptom scores before and after gluten exposure
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Finn-Medi Research Ltd, Outpatient Clinic
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00004757: Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Simplex
Keywords: herpes simplex virus infection
herpesvirus infection
immunologic disorders and infectious disorders
rare disease
viral infection
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2000-02-25
Sex: ALL
Minimum age (years): 0
Maximum age (years): 29
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine whether acyclovir (ACV) oral suspension suppresses recurrent skin lesions and improves neurologic outcome in neonates with localized herpes simplex virus type 2 infection when administered for 6 months in a placebo-controlled study.

II. Determine whether the prevention of recurrent skin lesions reduces long-term neurologic morbidity.

III. Determine whether resistant disease develops after oral ACV therapy. IV. Evaluate the natural history of recurrent skin lesions. V. Measure any adverse effects and laboratory abnormalities associated with long-term oral ACV therapy in infants and young children.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.

All patients are treated with intravenous acyclovir for 14 days. Patients are then randomly assigned to 1 of 2 treatment groups if the following criteria are met: no systemic disease involvement, documented by negative cerebrospinal fluid exam, brain computerized tomography, and magnetic resonance imaging; and entry criteria continue to be met.

Randomized treatment begins 8 hours after the final dose of intravenous acyclovir. One group is treated with oral acyclovir, while the control group receives an oral placebo.

Treatment continues for 6 months in the absence of unacceptable toxicity, systemic disease, and 2 or more recurrences of skin lesions. Patients are followed at 6 months, then yearly for at least 4 years.

The study duration is estimated to be 4 years.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Virologically confirmed herpes simplex virus type 2 (HSV-2) with skin lesions localized to the skin, eyes, and mouth
* No central nervous system or disseminated disease Normal cerebrospinal fluid WBC less than 20 Protein less than 90 mg/dL
* Normal brain computerized tomography or magnetic resonance imaging (MRI) MRI if feasible
* No HSV-1

--Patient Characteristics--

* Age: Under 29 days
* Renal: Creatinine no greater than 1.5 mg/dL
* Other: Birth weight at least 1200 g
* Gestational age greater than 32 weeks
* No breast feeding if mother on acyclovir

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
name: Richard J. Whitley
role: STUDY_CHAIR
References:
Clinical trial NCT00409357: Dose Ranging Study of Alfuzosin in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia
Official title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Ranging Study of SL77.0499-10 Once Daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Benign Prostatic Hyperplasia
Keywords: urinary tract
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-12-08
Enrollment: 473
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to assess the dose-response relationship of SL77.0499 10 (alfuzosin hydrochloride) 5 mg, 10 mg, 15 mg, and placebo once daily during a 12-week oral administration period for the efficacy in patients with lower urinary tract symptoms (LUTS) related to BPH.

Secondary objectives are to assess the efficacy of each dose of alfuzosin as compared with placebo and to assess the safety of each dose of alfuzosin.


Eligibility criteria: Inclusion Criteria:

* suffering from LUTS related to BPH for at least 6 months;
* having an IPSS \>13;
* having a urinary peak flow rate 5.0 to 12.0 mL/s for a voided volume of at least 150 mL;
* having a residual urine volume \< or = 200 mL.

Primary outcomes:
measure: The primary efficacy assessment is the change from baseline in International Prostate Symptom Score (IPSS) total score at the end-of-study (EOS) visit.
Secondary outcomes:
measure: Efficacy: changes from baseline in IPSS total score by visit;·IPSS irritative and obstructive subscores,·urinary peak flow rate and residual urine volume at EOS and by visit.
measure: Safety: adverse events, vital signs, laboratory tests.
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02902757: FDG PET/CT in Monitoring Very Early Therapy Response in Patients With Glioblastoma
Official title: Very Early Response Monitoring in Patients With Glioblastoma Undergoing Therapy Using FDG PET/CT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioblastoma
Keywords: FDG
PET/CT very early response (48 hrs)
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2016-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot clinical trial studies fluordeoxyglucose (fludeoxyglucose) F-18 (FDG) positron emission tomography (PET)/computed tomography (CT) in monitoring very early therapy response in patients with glioblastoma. Diagnostic procedures, such as FDG PET/CT, may help measure a patient's response to earlier treatment. Chemotherapy can induce very rapid changes to the tumor's glucose consumption which can be measured with imaging. FDG PET/CT shortly after the start of therapy may help identify very early therapy response in patients with glioblastoma.

Detailed description: PRIMARY OBJECTIVES:

I. To assess very early response to therapy in glioblastoma patients using 18F-FDG PET/CT.

II. Evaluate very early changes in FDG uptake within 48 hours of start of therapy and correlate them with objective response parameters such as Response Assessment in Neuro-Oncology (RANO) and survival.

OUTLINE:

Patients undergo standard FDG PET/CT scan 6-8 weeks before start of chemotherapy and one additional FDG PET/CT scan within 48 hours of the start of chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically proven high grade glioma
* Intention to start therapy

Exclusion Criteria:

* Severe psychiatric illness
* Inability to give written consent
* Breast feeding / pregnancy

Primary outcomes:
measure: Changes in glucose uptake
timeFrame: From baseline up to 48 hours
measure: Very early changes in tumor glucose uptake predictive for objective treatments response and survival assessed using RANO criteria
timeFrame: One PET/CT 48 hours after start of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Johannes Czernin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03303157: REM Sleep and Dreaming- a Case Study
Official title: REM Sleep and Dreaming- a Case Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-10-05
Enrollment: 1
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: one subject

Brief summary: a case study of a man with a unique condition that negatively affects his sleep architecture. we want to study this man's sleep and see (through interviews) how his condition affects his ability to dream


Eligibility criteria: Inclusion Criteria:

- one patient- not relevant

Exclusion Criteria:

-

one patient- not relevant

Primary outcomes:
measure: dream reports
timeFrame: 5 nights
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01006057: A Trial Investigating the NN1250 Concentration-time Curve in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function
Official title: A Trial Investigating the Pharmacokinetic and Safety of NN1250 in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-11-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the NN1250 (insulin degludec/insulin 454) concentration-time curve is altered to such an extent that the dose should be adjusted in subjects with impaired renal function compared to the dose for subjects with normal renal function.


Eligibility criteria: Inclusion Criteria:

* Subject with normal renal function or renal impairment (mild, moderate, severe or end stage renal disease (ESRD) requiring haemodialysis)
* Body mass index maximum 40.0 kg/m\^2

Exclusion Criteria:

* Subject with any disease or condition which the Investigator feels would interfere with the trial except for conditions associated with renal impairment in the group of subjects with compromised renal function. Diabetes mellitus can be accepted in the group of patients with renal impairment, but not in subjects with normal renal function
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Significant history of alcoholism or drug/chemical abuse
* Not able or willing to refrain from smoking during the inpatient period

Primary outcomes:
measure: Area under the insulin degludec concentration-time curve
timeFrame: from 0 to 120 hours after trial product administration
Secondary outcomes:
measure: Maximum observed insulin degludec concentration
timeFrame: from 0 to 120 hours after trial product administration
measure: Renal clearance of insulin degludec after single-dose
timeFrame: from 0 to 24 hours after trial product administration
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kiss I, Arold G, Roepstorff C, Bottcher SG, Klim S, Haahr H. Insulin degludec: pharmacokinetics in patients with renal impairment. Clin Pharmacokinet. 2014 Feb;53(2):175-83. doi: 10.1007/s40262-013-0113-2.
Clinical trial NCT03103048: Application of Different Techniques of Elastic Bandage
Official title: Application of Different Techniques of Elastic Bandage: Quantification Electromyographic at the Isometric Effort of Flexor Muscle of Fist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Forearm Muscle Strain
Lead sponsor: University of Mogi das Cruzes
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study will be featured as a randomized controlled. As the dependent variable, was considered isometric grip manual force. As independent variable, the presence or absence of forearm bandage in the fist flexor region of the volunteers.

Detailed description: This study is directed to the population of students at the University of Mogi das Cruzes (UMC), and will take part of this study forty volunteers, twenty men and twenty women, aged from eighteen and thirty-eight years old. Will be selected and included volunteers who do not do physical professional activity with upper members, which have no symptom of pain skeletal muscle in the upper members, which have not undergone any type of surgery in the region of the forearm and hand of both members. Will be excluded the volunteers who have injuries, joint injuries, neuromuscular disorder or those who have knowledge of own vestibular or neurological changes. Will also be excluded from study volunteers who do not agree to participate after reading and understanding of informed consent in accordance with resolution 466/12 of the National Ethics Committee and Research. The data acquisition interface will be acquired by an electromyography e a standard of strentgh will maintened in forty Newtons assured by an electronic dynamometer for tests of palmar prehension without and with bandages. The volunteers will not know what kind of intervention will pass. After each application before testing, their both forearms will be covered with a protection. The researcher and the volunteers will not know the tests order.

Eligibility criteria: Inclusion Criteria:

* Who do not do physical professional activity with upper members;
* Who have no symptom of pain skeletal muscle in the upper members;
* Who have not undergone any type of surgery in the region of the forearm and hand of both members;
* Consent form signed by the volunteer.

Exclusion Criteria:

* Having less than 18 years old;
* Having more than 38 years old;
* To present some compromise skeletal muscle in the upper members;
* Who do not want take part in the research;
* Who do not signed consent form as volunteer.

Primary outcomes:
measure: Efforts
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mogi Das Cruzes
country: Brazil
facility: Terigi Augusto Scardovelli
state: São Paulo
Study officials:
affiliation: University of Mogi das Cruzes
name: Terigi A Scardovelli, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06921057: Effects of Exergames on Muscle and Lung Function in Elderly
Official title: Effects of Exergames on Muscle Strength and Lung Function in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 34
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to examine the effects of 8-weeks exergames program on pulmonary function, muscle strength and cognitive function in elderly.

Participants will:

Play exergame 30min/session, 2 sessions/week or remained regular daily activities for 8 weeks.

Detailed description: Subjects who are older than 60 years will be assigned to exergame group or control group randomly.

Exergame group: Subjects will receive exergame program 30min/session, 2 sessions/week for 8 weeks.

Control group: Subjects remain regular daily activities for 8 weeks. Both groups receive pre- and post- measurements. The measurements included assessment of muscle strength and lung function.

Eligibility criteria: Inclusion Criteria:

1. age \> 60 years,
2. sufficient cognitive capacity to provide informed consent,
3. ability to understand and speak Chinese or Taiwanese.

Exclusion Criteria:

1. medical conditions prohibiting physical exercise
2. physical or cognitive disabilities preventing participation in or comprehension of the exergame.

Primary outcomes:
measure: forced expiratory volume at 1 sec (L)
timeFrame: week 0 and week 8
measure: forced expiratory volume at 1 sec (%)
timeFrame: week 0 and week 8
measure: forced vital capacity(L)
timeFrame: week 0 and week 8
measure: forced vital capacity(%)
timeFrame: week 0 and week 8
measure: arm curl test
timeFrame: week 0 and week 8
measure: hand grip strength
timeFrame: week 0 and week 8
measure: Mini-Mental State Examination
timeFrame: week 0 and week 8
measure: Montreal Cognitive Assessment
timeFrame: week 0 and week 8
Secondary outcomes:
Other outcomes:
Locations:
city: TaoYuan City
country: Taiwan
facility: Chang Gung University
Study officials:
affiliation: Chang Gung University
name: Yen-Huey Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: