louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00060489: Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Depression, Bipolar
Keywords: Bipolar Depression
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2003-05-08
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of quetiapine in the treatment of a major depressive episode in patients with bipolar disorder.


Eligibility criteria: Inclusion Criteria:

* Written Informed Consent;
* Bipolar disorder with most recent episode depressed;
* Outpatient status

Exclusion Criteria:

* Patients with a current Axis I disorder other than bipolar disorder within 6 months of screening;
* Patients whose current episode of depression exceeds 12 months or is less than 4 weeks

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Beverly Hills
country: United States
state: California
city: La Mesa
country: United States
state: California
city: San Diego
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Smyrna
country: United States
state: Georgia
city: Oakbrook
country: United States
state: Illinois
city: Shreveport
country: United States
state: Louisiana
city: Clementon
country: United States
state: New Jersey
city: Moorestown
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Columbia
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Falls Church
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Kirkland
country: United States
state: Washington
Study officials:
References:
citation: Lydiard RB, Culpepper L, Schioler H, Gustafsson U, Paulsson B. Quetiapine monotherapy as treatment for anxiety symptoms in patients with bipolar depression: a pooled analysis of results from 2 double-blind, randomized, placebo-controlled studies. Prim Care Companion J Clin Psychiatry. 2009;11(5):215-25. doi: 10.4088/PCC.08m00659.
Clinical trial NCT01931189: Pharmacokinetics Study of NI-071
Official title: A Clinical Pharmacokinetics Study of NI-071
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Nichi-Iko Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-29
Enrollment: 96
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess equivalence of pharmacokinetics between NI-071 and infliximab(the comparator) in Japanese healthy volunteers


Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, clinical laboratory tests, etc.)
2. Body Mass Index (BMI) of 18.5 to 25.0 kg/m2, and a total body weight of 50 to 80 kg

Exclusion Criteria:

1. Subjects with a following past History or concomitant diseases

   * Chronic or recurrent infectious disease
   * Demyelinating disease
   * Congestive heart failure
   * lymphoproliferative disorder or myelodysplastic syndrome
   * Malignancy
   * Interstitial lung disease
2. Subjects with active or latent tuberculosis or history of tuberculosis

Primary outcomes:
measure: PK : Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt)
timeFrame: 8 weeks
Secondary outcomes:
measure: PK : Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf)
timeFrame: 8 weeks
measure: Safety : Incidence of Adverse Events
timeFrame: 8 weeks
measure: Safety : Incidence of Anti-Drug Antibodies(ADA)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: NichiIko Investigational Site
Study officials:
References:
Clinical trial NCT05047289: Indiana University Gastric Electrical Stimulation Registry
Official title: Indiana University Gastric Electrical Stimulation Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Gastroparesis
Keywords: gastroparesis
gastric electrical stimulator
GES
vomiting
nausea
bloating
post prandial fullness
epigastric pain
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Purdue University
First posted: 2021-09-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will evaluate male and female patients at least 18 years of age, with gastroparesis, who will or have already undergone the implantation of a GES device (Enterra, Medtronic, Minneapolis, MN)

Brief summary: The purpose of this study is to develop a clinical registry in patients with Gastric Electrical Stimulation (GES) therapy for gastroparesis to support future gastrointestinal therapies, medical procedures and diagnostics.

Detailed description: This study will evaluate male and female patients at least 18 years of age, with gastroparesis, who will or have already undergone the implantation of a GES device

The study will be conducted at one center and approximately 1,000 subjects will be enrolled.

Subjects undergoing the GES implantation will be enrolled before the implantation and may have a baseline visit. The visit procedures will be conducted at the discretion of the investigator dependent on the clinical condition of the patient at that time.

Eligibility criteria: Inclusion Criteria:

* Patients undergo implantation of a new GES device for medical refractory gastroparesis

Exclusion Criteria:

* Non-ambulatory patients: bed-ridden, nursing home resident, etc.
* Pregnancy
* Unable to give own informed consent.
* Prisoners

Primary outcomes:
measure: To develop a clinical registry in patients with GES therapy
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: John Wo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01548989: Validation of a New Sexuality Questionnaire for Patients With Urinary Incontinence or Pelvic Organ Prolapse
Official title: Validation of a New Sexuality Questionnaire: a Tool for Evaluating the Sexuality of Patients With Urinary Incontinence or Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Urinary Incontinence
Fecal Incontinence
Keywords: linguistic validation of a new questionnaire
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.

Brief summary: The main objective of this study is to perform the linguistic validation of a new french questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress urinary incontinence or genital prolapse.


Eligibility criteria: Inclusion Criteria:

* The patient is able to read and understand French
* The patient must be insured or beneficiary of a health insurance plan
* Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.

Exclusion Criteria:

* Patient is pregnant
* The patient is under judicial protection, under tutorship or curatorship
* The patient does not understand French

Primary outcomes:
measure: Patient comprehension
timeFrame: Baseline (Day 0; transversal study)
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Brigitte Fatton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01464489: Intubation Time With Low Dose Rocuronium
Official title: Study of Intubation Time Required for Excellent Tracheal Intubation With Low Dose Rocuronium During Propofol Anaesthesia in Children With and Without Atropine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult
Keywords: Intubation time
Atropine
Propofol anesthesia
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2011-11-03
Enrollment: 44
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators hypothesized that increasing the cardiac output by use of atropine in children might result in a reduction of the intubation time needed to facilitate tracheal intubation.

Detailed description: The investigators hypothesized that increasing the cardiac output by use of atropine in children might result in a reduction of the intubation time needed to facilitate tracheal intubation. Therefore, the purpose of this study was to determine TimeEI with a low dose of esmeron (rocuronium) (0.3 mg.kg-1) for achievement of successful tracheal intubation conditions during intravenous (i.v.) anaesthesia using propofol and alfentanil in children and to determine whether administration of i.v. atropine (atropine sulphate) (10 μg.kg-1) during anaesthesia induction reduced these times.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I,
* Tonsillectomy with adenoidectomy

Exclusion Criteria:

* Patients with known allergy to the drugs used in this study,
* A history of reactive airway disease and asthma,
* A neuromuscular disorder, an anticipated difficult airway, and
* Crying children on arrival in the operating theatre

Primary outcomes:
measure: intubation time
timeFrame: intubating condition at 120 seconds from rocuronium injection
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Ajou University School of Medicine
name: Jong Yeop Kim, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Stoddart PA, Mather SJ. Onset of neuromuscular blockade and intubating conditions one minute after the administration of rocuronium in children. Paediatr Anaesth. 1998;8(1):37-40. doi: 10.1046/j.1460-9592.1998.00719.x.
Clinical trial NCT03034889: Anesthesia Related Neurocognitive Deficits in Children
Official title: Neurocognitive Development in Children Who Received General Anesthesia Before the Age of 3 Years: A Historic-prospective, Controlled, Single Center Cross-section Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: Anesthesia
Children
General Anesthesia
Neurocognitive Outcome
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 700
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children age 4-10 who underwent general anesthesia below the age of 36 months in context of surgical or diagnostic procedures or sedation uring intensive care.

Brief summary: The infantile brain has to pass essential, mayor steps in the first 36 months of life. During that period of development it is particularly vulnerable to toxic, exogenic influences. This study wants to review the long-term effects of children who were exposed to anesthesia in the first three years of their life. Therefore the investigators will examine children at age of 4-10 that were exposed to anesthesia and compare their neurocognitive capacity to children who did not have any exposure to anesthesia. The investigators plan on measuring the intelligence quotient using standardized tests which will be performed by a trained psychologist. In addition there will be a questionnaire concerning behavioral characteristics and educational development which is filled by the parents. The exposed children will be recruited from our preexisting database, the control group will be recruited from practitioners and the pediatric walk-in-clinic.


Eligibility criteria: Inclusion Criteria:

* General anesthesia before the age of 36 months

Exclusion Criteria:

* neurosurgical interventions
* cardiac surgery
* preexisting hereditary or acquired cognitive deficits
* no informed consent

Primary outcomes:
measure: Cognitive Capacity for children between 7 and 10 years of age
timeFrame: Test is done 1 to 10 years after anesthesia and is lasting 3 hours
measure: Cognitive Capacity for children between 4 and 7 years of age
timeFrame: Test is done 1 to 10 years after anesthesia and is lasting 3 hours
measure: Cognitive Capacity for children between 2 and 4 years of age
timeFrame: Test is done 1 to 10 years after anesthesia and is lasting 3 hours
Secondary outcomes:
measure: Educational status
timeFrame: 1 to 10 years after anesthesia, lasting 30 minutes
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital
state: Bavaria
Study officials:
References:
Clinical trial NCT01857089: Characterization of Sitting Postures in Healthy Subjects
Official title: Characterization of Sitting Postures in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: Pressure Ulcer
prevention
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to assess the intra and inter-subjects variability of the pressure measurement cartography in healthy and well and able volunteers, sitting on a rigid base during two hours.

Detailed description: * The purpose of this study is to understand the formation of pressure sore, to improve the care of paraplegic patients.
* This pilot study is going to help to establish a model in healthy volunteers in the prevention of pressure sores.

Eligibility criteria: Inclusion Criteria:

* more or equal than 18 years old
* age between 20 and 30 years old
* affiliation to social security or similarly regime

Exclusion Criteria:

* Person with pacemaker
* Person with a history of lumbar pain, chest or/and cervical pain.
* Person with an history of lumbar, chest or/and cervical muscular disorders,
* Person with history of circulatory problems,
* Person with history of skin pathologies at the seat area,
* Protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
* Person having a total annual compensation for the participation in biomedical research higher than €4460.

Primary outcomes:
measure: Assessment of intra and inter-subjects variability of the pressure measurements for the whole population included.
timeFrame: 2 hours
Secondary outcomes:
measure: Correlation between interface pressure measurements and postural data.
timeFrame: 2 hours
Other outcomes:
measure: Correlation between interface pressure measurements and the response to micro electrical stimulation of the buttock.
timeFrame: 2 hours
Locations:
city: Grenoble
country: France
facility: CIC-IT GrenobleUniversityHospital
Study officials:
affiliation: INSERM-CIC-IT
name: Alexandre MOREAU-GAUDRY, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01777789: The Role of Mid-Life Adiposity in Functional Brain Connectivity
Official title: The Role of Mid-Life Adiposity in Functional Brain Connectivity
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alzheimer's Disease
Keywords: fMRI
Dementia
Alzheimer's disease
functional neuroimaging
Memory
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers from the community

Brief summary: The purpose of the study is to use functional MRI (fMRI) to measure brain connectivity in middle-aged individuals with different levels of body fat. The ultimate goal of this research is to develop an early diagnostic tool for Alzheimer's disease.

Detailed description: Participants will have one visit for:

* Blood draw
* Body composition scan
* Cognitive screen
* Neurological exam
* MRI scan

The visit will take approximately 3 hours.

Eligibility criteria: Inclusion Criteria:

* 45-65 years of age
* Normal memory
* Right-handed
* General good physical health

Exclusion Criteria:

* History of stroke or neurological disease
* Seizures or head injury with loss of consciousness within the last five years
* Ferrous (magnetic) or electronic implants (due to the magnet in the MRI scanner)
* Claustrophobia

More detailed inclusion/exclusion criteria must be met in order to qualify for the study. The study coordinator will determine eligibility.

Primary outcomes:
measure: Brain connectivity measured by fMRI
timeFrame: One visit
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin/Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Piero Antuono, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04021589: Chemotherapy w/wo WeiLeShu in Metastatic Colorectal Cancer
Official title: A Study of Chemotherapy With WeiLeShu Versus Chemotherapy Alone in Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Microbial Colonization
Colorectal Cancer
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 40
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: A total of 50 patients with metastatic colorectal cancer will be enrolled in the study. The patients were randomly divided into the WLS-intervention group and the control group. The two groups of patients were given the most appropriate medication according to the specific conditions of the disease. Patients in the intervention group received additional oral administration of Weileshu, a probiotics product (Tongchuang Biotechnology).


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age, of any race or sex who are eligible to sign written consent and have undergone prior resection of histological evidence of colorectal cancer
* Hematologic function: ANC ≥ 1.5 x 10 /L, platelets ≥ 75 x 10 /L, and hemoglobin \> 9 g/dL Adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 5 ULN, albumin ≥ 2.5 g/dl Adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, \> 50 ml/min calculated by the C-G equation Non-pregnant women of childbearing potential and fertile men are required to use effective contraception (negative pregnancy test for women of child-bearing age) ECOG status ≤ 1 at screening

Exclusion Criteria:

-

Primary outcomes:
measure: progression free survival
timeFrame: up to approximately half a year
Secondary outcomes:
measure: overall survival
timeFrame: up to approximately two years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First affiliated hospital, Zhejiang University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Weijia Fang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01121289: A Trial Investigating NN1218 in Subjects With Type 1 Diabetes
Official title: A Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-05-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus for more than 12 months
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months
* Body mass index (BMI) between 18.0-28.0 kg/m2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the serum NN1218 concentration-time curve
timeFrame: From 0-1 hours
Secondary outcomes:
measure: Area under the serum NN1218 concentration-time curve
timeFrame: From 0-10 hours
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: