louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02684149: Pain Impact Assessment of the Relational Touch During Arterial Puncture in ICU (TORREA)
Official title: Pain Impact Assessment of the Relational Touch During Arterial Puncture in ICU - TORREA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Intensive care
Arterial puncture
Cross-over
Relational touch
Pain
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-02-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study objective is to assess the interest of the relational touch before an arterial puncture to reduce pain on patient in intensive care unit.


Eligibility criteria: Inclusion Criteria:

* Admission in Intensive Care Unit
* Communicating patient (able to rate their pain on a numerical scale)
* Need for a radial arterial puncture for conducting blood tests, apart for the emergency
* Non-opposition of the patient

Exclusion Criteria:

* Age under 18
* Tetraplegic patient or having a sensitivity disorder on the limb to be punctured
* No radial pulse perception

Primary outcomes:
measure: The primary endpoint is the variation in pain score (evaluation on a numerical scale 0 to 10) between the measurement made before the arterial puncture and during the arterial puncture.
timeFrame: 1 day
Secondary outcomes:
measure: The change in consumption of analgesics and hypnotics
timeFrame: 1 day
measure: Blood pressure and heart rate variation
timeFrame: 1 day
measure: Patient satisfaction score
timeFrame: 1 day
measure: Number of arterial punctures needed before success
timeFrame: 1 day
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
city: Tours
country: France
facility: University Hospital TOURS
Study officials:
affiliation: University Hospital, Angers
name: Régine MONCHO, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01311349: Study Evaluating Local Susceptibility Patterns Associated With Tigecycline in Comparison to Other Antibiotics
Official title: Evaluation of the Antimicrobial Activity In Vitro of Tigecycline in Comparison to Other Broad Spectrum Antibiotics in Isolates Collected From Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: Susceptibility of tigecycline
Drug Resistance, Bacterial
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2011-03-09
Enrollment: 1575
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients and outpatients

Brief summary: Various bacterial organisms will be tested in order to compile information regarding the effectiveness of tigecycline against certain bacteria seen in local communities.

Detailed description: This is a prospective, microbiologic in vitro evaluation which will study the susceptibility of tigecycline in disk diffusion on clinical bacterial isolates collected from inpatients and outpatients. Fourteen hospital centers participated in the program. In vitro efficacy of tigecycline will be determined through the in vitro disk diffusion activity, using FDA breakpoints.

Eligibility criteria: Inclusion Criteria: Any protocol-specified microorganism isolated from the samples collected from hospitalized patients and outpatients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00368706: A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients
Official title: A Randomized, Double-Blind, Paralleled, Active Controlled, Multi-Center Study of the Efficacy and Safety of 5mg Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Bladder, Overactive
Keywords: solifenacin
Overactive bladder
Urinary incontinence
Treatment outcomes
VESIcare
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-08-25
Enrollment: 246
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: To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid


Eligibility criteria: Inclusion Criteria:

* Patients willing and able to complete the micturition diary correctly
* Patients experiencing frequency of micturition as verified in the diary
* Patients experiencing significant post void residual volume
* OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months or more.

Exclusion Criteria:

* Significant post void residual volume
* Patients with indwelling catheters or practicing intermittent self- catheterization
* Known or suspected hypersensitivity to solifenacin succinate or other anticholinergics or lactose

Primary outcomes:
measure: Change from baseline in mean number of micturitions per 24 hours
timeFrame: 8 Weeks
Secondary outcomes:
measure: Change from baseline in mean volume voided per micturition
timeFrame: 8 Weeks
measure: Change from baseline in mean number of incontinence episodes per 24 hours
timeFrame: 8 Weeks
measure: Change from baseline in mean urgency frequency per 24 hours
timeFrame: 8 Weeks
measure: Change from baseline in mean nocturia episodes per 24 hours
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Beijing
country: China
city: Chong Qing
country: China
city: Hang Zhou
country: China
city: Shanghai
country: China
Study officials:
affiliation: Peking University First Hospital
name: Use Central Contact
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05781906: Human Mass Balance of [14C]HMPL-523 in Healthy Adult Male Chinese Subjects
Official title: Single-center, Open-label, Multi-dose Study to Investigate the Human Mass Balance in Healthy Adult Male Following Multiple Oral Doses of HMPL-523 Tablets Followed by a Single Oral Dose of 300 mg/150 µCi [14C]HMPL-523 Suspension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Imumune Thrombocytopenia(ITP) Human Mass Balance
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2023-03-23
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate the absorption, metabolism and excretion of HMPL-523 in healthy male Chinese subjects following multiple oral doses of HMPL-523 tablets followed by a single oral dose of \[14C\]HMPL-523 suspension

Detailed description: a single-center, non-randomized, open-label, human mass balance, phase 1 study to evaluate the absorption, metabolism and excretion following multiple oral doses of HMPL-523 tablets, followed by a single oral dose of 300 mg/150 µCi \[14C\]HMPL-523 suspension in healthy adult male Chinese subjects.

Eligibility criteria: Inclusion Criteria:

1. Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance;
2. Healthy male subjects aged 18-40 years (inclusive);
3. Subjects weighing ≥ 50 kg
4. Subjects in good health status

Exclusion Criteria:

1. Subjects with a history of gastrointestinal surgery, renal surgery, cholecystectomy and other procedures that in the judgment of the investigator may affect drug absorption or excretion
2. hypersensitivity to the investigational product and its excipients
3. Subjects with diseases affecting the absorption, distribution, metabolism and excretion of oral drugs,
4. Subjects with fear of needles, hemophobia, difficulty collecting venous blood, or special requirements for diet, who cannot comply with uniform diet
5. Subjects who are abnormal with clinical significance for C-reactive protein or positive for coronavirus nucleic acid detection in coronavirus infection screening
6. Subjects who have participated in another clinical trial of other drugs and have received such investigational product within 3 months prior to the first dose
7. Having any other diseases or conditions that may affect the normal performance of the study or the evaluation of the study data, or having other conditions that are not suitable for the study, as judged by investigators

Primary outcomes:
measure: the Human Mass Balance
timeFrame: Day1-Day7
measure: the Human Mass Balance
timeFrame: Day8
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: offices director
name: Liyan Miao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01450306: Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics
Official title: Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Specific Phobia
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2011-10-12
Enrollment: 20
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 aim of the present study is to determine whether people receiving d-cycloserine and exposure therapy show different brain reactions to symptom provocation compared to people receiving placebo and exposure therapy.

Detailed description: D-cycloserine (DCS) is a partial N-methyl-D-aspartate (NMDA) receptor agonist that may improve or accelerate extinction learning. We will randomly assign people with snake phobia to receive DCS or placebo, and then provide all participants with exposure therapy. We will examine whether people receiving DCS and vs. placebo show different brain reactions to symptom provocation before and after exposure therapy.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of specific phobia (snakes)

Exclusion Criteria:

* History of psychosis, obsessive-compulsive disorder, or mania
* Recent substance abuse or suicidality
* Previous receipt of study treatments

Primary outcomes:
measure: Snake Questionnaire (SNAQ)
timeFrame: 2 weeks
Secondary outcomes:
measure: Clinician's Global Impression (CGI)-Severity
timeFrame: 2 weeks
measure: Clinician's Global Impression (CGI)-Improvement
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Institute of Living/Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: David Tolin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nave AM, Tolin DF, Stevens MC. Exposure therapy, D-cycloserine, and functional magnetic resonance imaging in patients with snake phobia: a randomized pilot study. J Clin Psychiatry. 2012 Sep;73(9):1179-86. doi: 10.4088/JCP.11m07564.
Clinical trial NCT00076206: Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy
Official title: A Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Oral Dose Levels (1, 2, And 4 Mg) of CCI-779 in Subjects With Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2004-01-19
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 primary objective of this study is to compare the therapeutic response and safety of 3 oral dose levels of CCI-779, with placebo in subjects with active rheumatoid arthritis (RA) who have been receiving stable doses of methotrexate (MTX) for at least 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Meet American College of Rheumatology (ACR) criteria for RA
* Have active RA consisting of ≥ 6 swollen and ≥ 6 painful joints
* ACR functional class I-III

Exclusion Criteria

* At screening the subject's prior medications are reviewed. (Prior history of disease-modifying antirheumatic drug (DMARD) use is recorded, including the start and stop dates of the most recently taken DMARDs)
* Significant concurrent medical diseases
* Abnormal chest radiograph, including findings consistent with interstitial pneumonitis, granulomatous disease, or pleural effusion and/or infiltration

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03470506: A Study of the Relationship of Gut Microbial Composition and Stroke Outcome
Official title: A Study of the Relationship of Gut Microbial Composition and Stroke Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2018-03-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community probability sample of adults who have suffered an ischemic stroke within 48 hours of admission to UVA

Brief summary: The purpose of this study is to investigate the relationship between gut microbiome (bacteria in the gut), inflammation and the injured brain. It has been established that bacteria in the gut play key roles in digestion, nutrition absorption and immune response of the entire body. Human intestinal bacteria composition in the gut has been associated with several stroke risk factors including obesity, insulin resistance, diabetes and hypertension. If we can establish a relationship between gastrointestinal microbial community composition and ischemic stroke outcomes could lead to dietary interventions in the future to improve recovery after a stroke.


Eligibility criteria: Inclusion Criteria:

1. Men and women at least 18 years of age.
2. Willing and able to attend all study visits.
3. English speaking.
4. Must have had a stroke that occurred within 48 hours of admission to the Stroke Unit as determined by a neurologist.

Exclusion Criteria:

1. History of inflammatory bowel disease.
2. Receiving antibiotics within 30 days of entry into the study.
3. History of institutionalization for mental illness within the last year.
4. Unable to consent and does not have a surrogate available to consent on their behalf.

Primary outcomes:
measure: Measured differences in taxonomic make-up and the relative frequency of the gut microbial composition in relation to excellent vs. poor stroke outcome
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Cogstate cognitive correlates and post-stroke microbial composition
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Fairfax
country: United States
facility: Inova Health System
state: Virginia
Study officials:
affiliation: University of Virginia
name: Bradford Worrall, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01398306: Biomarkers for Angiogenesis in Renal Cell Carcinoma and Neuro-endocrine Tumours.
Official title: Biomarkers for Angiogenesis in Renal Cell Carcinoma and Neuro-endocrine Tumours.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma
Carcinoma, Renal Cell
Neuroendocrine Tumors
Carcinoid Tumor
Pancreatic Islet Cell Tumors
Keywords: Angiogenesis Inhibitors
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Angiogenesis Inducing Agents
Biological Markers
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with clear cell renal cell carcinoma with metastases and patients with low grade neuroendocrine tumours with metastases.

Brief summary: The primary objective of this study is to analyse the concentration dopamine and serotonin in thrombocytes of patients with renal cell carcinoma and neuro-endocrine tumours compared to the concentrations of these catecholamines in healthy volunteers. The concentration dopamine and serotonin in thrombocytes with and without medication will also be evaluated.

Detailed description: * To analyse the concentration catecholamines in thrombocytes of patients with clear cell renal cell carcinoma and low grade neuroendocrine tumours.
* To compare these concentrations with the concentrations catecholamines in thrombocytes of healthy controls.
* To analyse the concentration catecholamines in thrombocytes of patients with clear cell renal cell carcinoma and patients with low grade neuroendocrine tumours with and without medication.

Eligibility criteria: Inclusion Criteria:

* Age 18 years old or older.
* Patients with clear cell renal cell carcinoma with metastases or patients with a low-grade neuro-endocrine tumor with metastases.
* Written informed consent

Exclusion Criteria:

* Use of L-dopa or SSRI.
* Patients with a second primary malignancy.

Primary outcomes:
measure: Difference in concentrations DA and 5-HT in thrombocytes of patients with clear cell renal cell carcinoma and healthy controls, and patients with low grade neuroendocrine tumours and healthy controls.
timeFrame: one year
Secondary outcomes:
measure: Difference in concentrations DA and 5-HT in thrombocytes of patients with clear cell renal cell carcinoma and low grade neuroendocrine tumours with and without medication.
timeFrame: one year
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Sjoukje F. Oosting, MD
role: STUDY_CHAIR
affiliation: University Medical Center Groningen
name: Marloes A.M. Peters
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03482206: Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury
Official title: Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Traumatic brain injury (TBI) affects 1.7 million people in the United States each year, resulting in 2.5 million emergency department visits, 280,000 hospitalizations, \>50,000 deaths, and more than $60 billion in economic cost. TBI also affects \>30,000 military personnel annually and almost 8% of veterans who received care between 2001 and 2011. Post-traumatic neurologic outcome depends on the severity of initial injuries and the extent of secondary cerebral damage. Ischemia is the most common and devastating secondary insult. Ischemic brain damage has been identified histologically in \~90% of patients who died following closed head injury, and several studies have associated low cerebral blood flow (CBF) with poor outcome. Specifically, CBF of less than 200 ml/min has been shown to be the critical lower threshold for survival in neurointensive care patients. In addition to intracranial hypertension and cerebral edema, systemic hypotension and reduced cardiac output contribute substantially to posttraumatic cerebral ischemia. Additionally, the carotid artery is the most common site of blunt cerebral vascular injury (BCVI), which may further compromise CBF and cause subsequent death or debilitating stroke. Specifically, high grade internal carotid arterial (ICA) injuries are associated with the highest mortality and stroke rate.

The investigators' goal is to develop of a wearable noninvasive, continuous, automated ultrasound sensor to accurately measure extracranial ICA flow volume. In doing so, the investigators aim to enable early detection of CBF compromise, thereby preventing secondary ischemic injuries in TBI patients. To achieve this goal, the investigators plan to first build a prototype wearable ICA ultrasound senor with integrated signal processing platform, then test its accuracy in an in vitro system and healthy human subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Age 18 or older

Exclusion Criteria:

* Claustrophobic
* Hyperventilation or panic disorders
* Pregnant
* Have metal implants or cannot pass the MRI screening questions

Primary outcomes:
measure: Internal carotid artery blood flow
timeFrame: 5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement
Secondary outcomes:
measure: End tidal CO2 level
timeFrame: 5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement
Other outcomes:
Locations:
Study officials:
References: