louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00441987: Study Evaluating the Safety and Pharmacokinetics of a Single Dose of GSI-953
Official title: A Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSI-953 Administered Orally to Healthy Japanese Male Subjects and Healthy Elderly Male Japanese Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Japanese
Healthy
Alzheimers Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-01
Enrollment: 96
Sex: MALE
Minimum age (years): 20
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the protocol is to assess the initial pharmacokinetic (PK) profile of a single oral dose of GSI-953 to healthy male Japanese subjects and healthy elderly male Japanese subjects.


Eligibility criteria: * Healthy males aged 20 - 40 and healthy males aged greater than 65.
* Body mass index range of 17.6 - 26.4 kg/m2 greater than or equal to 45 kg.
* Non-smokers or smoker of fewer than 10 cigarettes a day.

Primary outcomes:
measure: Number of participants reporting Adverse Event
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kitashinagawa
country: Japan
state: Shinagawa-ku
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00193687: Bifeprunox in the Treatment of Schizophrenia
Official title: An Open-Label, Flexible-Dose, Long-Term Safety and Efficacy Study of Bifeprunox in the Treatment of Schizpohrenia (Extension of S154.3.001)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: open-label study in the treatment of schizophrenia
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 986
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia. Extension to study S154.3.001.


Eligibility criteria: Inclusion Criteria:

diagnosis of schizophrenia, understand nature of study, able to be managed in out-patient setting for long-term bifeprunox treatment

Exclusion Criteria:

current primary diagnosis other than schizophrenia, suicide risk, diagnosis or history of substance abuse, uncontrolled hypertension

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT02102087: Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device
Official title: A Matched, Open Label Study to Evaluate the Effectiveness of the MMT Initial Specimen Diversion Device in Reducing Blood Culture Contamination When Compared to Laboratory Standard Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septicemia
Lead sponsor: Magnolia Medical Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-02
Enrollment: 971
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a matched, open label study to evaluate the Initial Specimen Diversion Device (ISDD) in reducing the contamination rate in blood culture analysis. Blood culture data will be derived from inpatient and/or outpatient settings in a variety of hospital departments (e.g. ER, surgical, medical, etc.). Only samples that are collected via peripheral venipuncture may be included in this study. The ISDD will be compared to current laboratory practices for the collection of blood for culture purposes. Laboratory Standard Procedures (LSP) is defined as collection of venipuncture blood for culture without an initial diversion method to divert and sequester potential blood contaminants.


Eligibility criteria: Inclusion Criteria:

* Adults \>19 years old

Exclusion Criteria:

* Not a good candidate for direct-to-media (DTM) technique

Primary outcomes:
measure: Rate of blood culture contamination when using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP)
timeFrame: Baseline
Secondary outcomes:
measure: Occurrence rate of adverse device effects
timeFrame: Baseline
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
References:
citation: Rupp ME, Cavalieri RJ, Marolf C, Lyden E. Reduction in Blood Culture Contamination Through Use of Initial Specimen Diversion Device. Clin Infect Dis. 2017 Jul 15;65(2):201-205. doi: 10.1093/cid/cix304.
Clinical trial NCT00261287: Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Tolerability of Ciclesonide (200 mcg Once Daily), Applied as a Nasal Spray for Twelve Weeks, in the Treatment of Perennial Allergic Rhinitis (PAR) in Pediatric Patients 2-5 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hay Fever
Perennial Allergic Rhinitis
Keywords: Hay Fever
Allergic Rhinitis
Perennial Allergic Rhinitis
Ciclesonide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-12-05
Enrollment: 102
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of ciclesonide nasal spray for long term use in relieving symptoms in perennial allergic rhinitis.


Eligibility criteria: Main Inclusion Criteria:

* General good health, other than perennial allergic rhinitis
* History and diagnosis of perennial allergic rhinitis by skin prick test
* History of perennial allergic rhinitis for a minimum of 90 days immediately before the screening visit

Main Exclusion Criteria:

* Participation in any investigational drug trial within the 30 days before the screening visit
* Use of any disallowed concomitant medications within the prescribed withdrawal periods before the screening visit
* A known hypersensitivity to any corticosteroid

Primary outcomes:
measure: Safety and tolerability of ciclesonide nasal spray
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Normal
country: United States
facility: Altana Pharma/Nycomed
state: Illinois
city: San Antonio
country: United States
facility: Altana Pharma/Nycomed
state: Texas
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
Clinical trial NCT04124887: Remineralization Effect of Fluoride Varnishes on Permanent Molars
Official title: Remineralization Effect of NaF, NaF With TCP, NaF With CPP-ACP, and NaF With CXP Varnishes on Newly Erupted First Permanent Molars: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Remineralization
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate and compare the efficacy of NaF, NaF with TCP, NaF with CPP-ACP, and NaF with CXP varnishes on newly erupted first permanent molar teeth. The study was carried out in 40 healthy, high caries risk children (DMFS \>8), aged six to seven years with newly erupted permanent first molars who referred to the Pediatric Dentistry Clinic of Kırıkkale University Faculty of Dentistry, Kırıkkale, Turkey. A total of 140 teeth were divided randomly into four groups and the varnishes were applied to the determined teeth at baseline, one and three months. The same varnish was used, if there is more than one first molar to be applied of the same patient. The groups were comprised as follows:

Group 1: Duraphat Varnish containing 5% NaF (Colgate-Palmolive, NSW, Australia) (n = 35), Group 2: Clinpro™ White Varnish containing 5% NaF with TCP (3M ESPE, MN, USA) (n = 35), Group 3: Embrace ™ Varnish containing 5% NaF with CXP (Pulpdent, MA, USA) (n = 35), Group 4: MI Varnish containing 5% NaF with CPP-ACP (GC, Tokyo, Japan) (n = 35). All dental treatments of the patients were completed before the varnish application and oral hygiene instructions were given to all children at the start of the study.

Patients were called for follow up appointments at 1, 3 and 6 months, and in the follow-up period DIAGNOdent device (laser fluorescence scanning) was used to monitor mineralization changes. LF measurements were made at baseline (T0), after one month (T1) three months (T2) and six months (T3). Within and between group comparisons were analysed statistically.


Eligibility criteria: Inclusion Criteria:

Subject has at least one fully erupted permanent first molar tooth

Exclusion Criteria:

Subject has a permanent first molar tooth with visible cavitation on the tooth surface Subject has a partially erupted permanent first molar tooth.

Primary outcomes:
measure: Monitoring mineralization changes
timeFrame: One, three, six months
Secondary outcomes:
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale University
Study officials:
References:
Clinical trial NCT02229487: The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers
Official title: The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Keywords: Prediabetes
Short sleepers
GLP-1
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2014-09-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Hypothesis

1. Prediabetes patients who have insufficient sleep will have worse glucose tolerance than those with normal sleep duration.
2. Prediabetes patients with short sleep will have a delayed or reduced GLP-1 response to a standardized meal


Eligibility criteria: Inclusion Criteria:

1. Patients with prediabetes (HbA1c 5.7-6.4% or history of fasting plasma glucose 100-125 mg/dl) who receive medical care at Ramathibodi Hospital
2. Age 18 or older
3. Can understand Thai (speaking, listening and reading)
4. Agree to participate by written informed consent

Exclusion Criteria:

1. Those who depend on others for feeding (such as stroke patients)
2. Shift workers
3. History of congestive heart failure or low ejection fraction
4. Chronic obstructive pulmonary disease, end stage renal disease or chronic liver disease (AST or ALT \> 3 times the upper limit of normal)
5. Use of medications: opioids/ narcotics , alpha blockers (prazosin, doxazosin, terazosin), clonidine, methyldopa, nitroglycerin
6. Patients with permanent pacemaker
7. History of previous stroke

Primary outcomes:
measure: GLP-1 Levels in Response to Oral Glucose Tolerance Test
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Ramathibodi Hospital
Study officials:
References:
Clinical trial NCT05742087: Neuropathy and Anti-GFAP Antibodies
Official title: Study of the Consequences of Anti-GFAP Antibodies on the Peripheral Nervous System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurological Diseases or Conditions
Neurological Diseases Associated to Anti GFAP Antibodies
Keywords: GFAP
neuropathy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 120 patients presenting with neurological symptoms and with identified anti-GFAP antibodies in the CSF, included in the French cohort of patients with neurological syndroms and anti-GFAP antibodies identified in the cerebrospinal fluid (CSF) of the "Centre de reference des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes", will be studied.

Brief summary: Anti-Glial Fibrillary Acidic Protein (GFAP) are antibodies associated to inflammatory diseases of the central nervous system. The GFAP protein is highly expressed by astrocytes explaining these syndromes, but GFAP is also expressed by immature and non-myelinating Schwann cells. Thus, these antibodies could also lead to damages of the peripheral nervous system (PNS). Moreover, such damages have already been reported on small studies, and there is a need for larger cohorts.

The investigators will use the cohort of patients with neurological syndromes and anti-GFAP antibodies identified in the cerebrospinal fluid (CSF) of the "Reference center for paraneoplastic neurological syndromes and autoimmune encephalitis" to determine the frequency of the PNS involvement in these patients.


Eligibility criteria: Inclusion Criteria:

* - Age \> 18 years old
* Neurological symptoms
* Anti-GFAP antibodies identified in the CSF

Exclusion Criteria:

* - Uncomplete data in the medical records of patients

Primary outcomes:
measure: Cranial nerves abnormality at clinical examination of abnormal ENMG
timeFrame: Immediately after diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes
Study officials:
References:
Clinical trial NCT05797987: Negative ER Expression Assessed by 18F-FES PET/CT in the MBC With ER-positive Primary Tumor
Official title: Negative Estrogen Receptor (ER) Expression Assessed by 18F-fluoroestradiol Positron Emission Tomography/Computed Tomography (18F-FES PET/CT) in the Metastatic Breast Cancer (MBC) With ER-positive Primary Tumor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MBC patients with ER-positive primary tumor who detected negative ER expression in metastatic disease using 18F-FES PET/CT at the Fudan University Shanghai Cancer Center

Brief summary: To investigate the treatment pattern and efficacy of patients with positive primary ER lesion but negative ER expression in MBC using a novel convenient way of 18F-fluoroestradiol positron emission tomography/computed tomography (18F-FES PET/CT).


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with breast cancer (according to International Classification of Diseases 10th Revision) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
* MBC patients who underwent 18F-FES PET/CT at the Fudan University Shanghai Cancer Center between 2010 and 2022
* Patients diagnosed with primary ER-positive tumor and who were yet to receive any systemic therapy during the advanced stage

Exclusion Criteria:

* Patients with incomplete medical records and those diagnosed with secondary primary tumors

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Biyun Wang, MD
state: Shanghai
Study officials:
References:
Clinical trial NCT00262587: Elite Sport and Development of Asthma
Official title: Elite Sport and Development of Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Sport
Asthma
Treatment
Airway inflammation
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Imperial College London
name: Anti Doping Danmark
name: GlaxoSmithKline
name: The Research Foundation of Bispebjerg Hospital
name: Ragnhild Ibsens Legat For Medicinsk Forskning
First posted: 2005-12-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: International studies have shown that elite athletes have a high prevalence of respiratory symptoms and asthma as compared to normal subjects. It is unclear whether the increased prevalence of asthma in elite athletes reflects "traditional asthma" or whether it is a special form of "sports asthma". The treatment of elite athletes with asthma seems to vary widely, and only a few studies have focused on the treatment of elite athletes with asthma. Further knowledge of the pathogenesis of sports asthma would lead to a greater understanding and better treatment of the condition. This study will investigate the type of airway inflammation in elite athletes and examine the effect of treatment with inhaled steroids in combination with long-acting beta-agonists versus placebo in the same group.


Eligibility criteria: Inclusion Criteria:

* Elite athletes
* Informed consent
* Doctor diagnosed asthma

Exclusion Criteria:

* Current smoker or more than 10 pack-years
* Pregnancy, breast feeding or planning pregnancy during the study.
* ICS within the last 4 weeks prior to visit 1.

Primary outcomes:
measure: Eucapnic voluntary hyperventilation (EVH)
timeFrame: End of study
measure: Exhaled Nitric Oxide
timeFrame: End of study
Secondary outcomes:
measure: Respiratory symptoms
timeFrame: End of study
measure: Lung function
timeFrame: End of study
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Respiratory and Allergy Research Unit, Department of Respiratory Medicine, Bispebjerg Hospital
Study officials:
affiliation: Respiratory and Allergy Research Unit, Department of Respiratory Medicine
name: Thomas Lund, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05433987: Immune Activation Markers in HIV-infected Patients Switching to Long Acting Dual Therapy
Official title: Study Aiming to Measure the Impact on Immune Activation and Inflammatory Markers of Switching From a Triple Combination Antiretroviral Therapy (cART) to a Long Acting Dual Therapy in HIV-infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1-infection
Keywords: inflammatory markers
dual therapy
treatment simplification
Lead sponsor: Centre Hospitalier de Cannes Simone Veil
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 20
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: Patient HIV-1, regularly followed in Cannes and Nice Hospital and for which the doctor has decided to modify the treatment

Brief summary: The purpose of the study is to measure the impact on immune activation and inflammatory markers of switching from a triple combination antiretroviral therapy (cART) to a long acting dual therapy in HIV-infected patients

Detailed description: Patients meeting the inclusion criteria will be offered to participate to the study.

In case of acceptance by given their writting consent, 6 ml of blood will be collected for measuring immune activation and inflammatory markers, during the blood test scheduled for the routine follow-up.

Six months after cART change, an equal volume of blood will be collected for measuring the same immune activation and inflammatory markers

Eligibility criteria: Inclusion Criteria:

* Patients agreeing to participate to the study and to collect their data
* HIV-1 infected subjects
* Patients switching from a stable (at least 6 months) and successful triple cART to a long acting dual cART
* Patients older than 18 yrs and regularly followed in Cannes and Nice hospitals
* Patients with a healthcare card

Exclusion Criteria:

* HIV-2 infected subjects
* Patients not being on successful and stable cART
* Patients having being treated during acute HIV-infection
* Patients modifying cART for virological failure
* Subjects modifying their treatment for another combination than from a triple cART to a dual cART
* Patients modifying cART during the 6 months of follow-up
* Patients refusing to participate to the study
* Patients included in an interventional study during the 6 months of follwo-up
* Patient under juridical procedure

Primary outcomes:
measure: Evolution the trajectory of immune activation and inflammatory markers
timeFrame: Baseline and 6 months after modiyfying cART
Secondary outcomes:
measure: Prevalence of patients with successful cART
timeFrame: 1 month, 3 month, 6 month
Other outcomes:
Locations:
city: Cannes
country: France
facility: Nathalie DOUX
Study officials:
affiliation: Centre Hospitalier de Cannes Simone Veil
name: Matteo Vassallo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00131287: The Supplementary Effects of the Extract of Agaricus Blazei Murril on Type II Diabetes Mellitus (DM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type II
Keywords: Agaricus Blazei Murill
type II DM
insulin index
Lead sponsor: ECbiotech Taiwan
Sponsor class: OTHER
First posted: 2005-08-18
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether the extract of the Agaricus blazei Murill mushroom is effective in the supplementary treatment of type II DM patients.

Detailed description: The researchers have the animal model that the extract of the Agaricus blazei Murill mushroom is effective in the treatment of type II DM mice conducted on 2002. The dose effects were also found. The researchers conducted the pilot study also showing the same effects in 2003. So the researchers designed this trial. The elixir of the Agaricus blazei Murill mushroom is popular in Taiwan for chronic diseases, such as type II DM.

Eligibility criteria: Inclusion Criteria:

* Type II DM
* Age 20-75 years old
* Treat with Gliclazide and Metformin
* Signed informed consent

Exclusion Criteria:

* GOT/GPT \>80/80
* Creatinine \> 2.0
* Lactating or pregnant women

Primary outcomes:
measure: Percent reduction of glycated hemoglobin (HAb1C) and insulin resistance(HOMA-IR)
Secondary outcomes:
measure: Glucose, cholesterol, triglyceride, leptin, adiponectin comparisons
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chung-Hua Hsu
Study officials:
affiliation: Chinese Medicine Dep, Taipei Hospital
name: Hsu Chung-Hua, MD
role: PRINCIPAL_INVESTIGATOR
References: