louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00875628: A Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers
Official title: A Phase 1, Randomized, Double Blind (Sponsor-Open), Placebo Controlled, Dose Escalation, Multiple Dose Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Japanese Healthy volunteers HCV pharmacokinetics PF-00868554 filibuvir
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Investigation of safety, tolerability, and pharmacokinetics of PF-00868554 following multiple oral administrations of PF-00868554 in Japanese healthy adult volunteers.

Detailed description: Study A8121018 was prematurely discontinued due to FDA instructions stating that Study A8121018 could not be performed under US IND 78,910, which was provided by the meeting on August 13, 2009. And then the termination was decided by Pfizer on September 8, 2009 prior to subject dosing with PF-00868554. There were no safety concerns regarding the study in the decision to terminate the trial.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female Japanese subjects between the ages of 18 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
* Exposure within the previous three months to a drug known to have a negative effect on skeletal muscle or reproductive organs.
* Pregnant or nursing females; females of childbearing potential.

Primary outcomes:
measure: Plasma PF-00868554 concentrations
timeFrame: Day 1-Day 17
measure: Urine PF-00868554 concentrations
timeFrame: Day 1 and Day 14
measure: Adverse event monitoring and Physical examination
timeFrame: Day 0-Day 17
measure: ECGs and vital signs (Blood pressure and Pulse rate)
timeFrame: Day 1-Day 17
measure: Clinical safety laboratory tests
timeFrame: Day 0, Day 7, and Day 17
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04821128: Radio/Pathological Evaluation of Tongue Cancer Infiltration
Official title: An Evaluation of the Radio/Pathological Correlation of Depth Of Invasion for Oral Squamous Cell Carcinoma, a Retrospective Study in a University Hospital in Lyon
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Squamous
Cell Carcinoma
Keywords: DOI
Infiltration
Oral cavity cancer
OSCC
Tongue cancer
CT scanner
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will include all the patients chirurgically treated for an OSCC for 2014 to 2019, who have a pre operativ scanner at least in their medical file.

We will exclude the T4, the patients with very artefacted exams, and those with R+ resections.

Brief summary: The aim of the study is to assess the good correlation and prediction of the DOI for the post-operative pathological results and prognosis.


Eligibility criteria: Inclusion Criteria:

* patients chirurgically treated for an OSCC
* T1 T2 T3
* CT scanner in their medical file

Exclusion Criteria:

* T4
* R+ résection
* Artefacts on CT scanner

Primary outcomes:
measure: The primary outcome will be the measure of the correlation of the depth of invasion on the radiological pre operative images and of the pathological analyses on the resection piece.
timeFrame: The outcome will be measured at the inclusion of the patient in the current study.
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix rousse hospital
Study officials:
References:
Clinical trial NCT01017328: Effect of Head Rotation on Overlap and Relative Position of Internal Jugular Vein to Carotid Artery in Infants and Children: A Study of the Anatomy Using Ultrasonography
Official title: Effect of Head Rotation on Overlap and Relative Position of Internal Jugular Vein to Carotid Artery in Infants and Children: A Study of the Anatomy Using Ultrasonography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: infants and children undergoing surgery with general anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-11-20
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants and children undergoing surgery with general anesthesia

Brief summary: Effect of head rotation on overlap and relative position of internal jugular vein to carotid artery in infants and children: A study of the anatomy using ultrasonography.


Eligibility criteria: Inclusion Criteria:

* Paediatric patients scheduled for elective urologic surgery were enrolled on a convenience basis, irrespective of their diagnosis or whether central venous access was planned.

Exclusion Criteria:

* Infants or children with possible c-spine disorders or haemodynamic instabilities.

Primary outcomes:
measure: comparison of internal jugular vein's relative position to carotid artery in children
timeFrame: noninvasive ultrasonographic observation after inducing general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
Study officials:
affiliation: Professor of Anesthesiology, Severance Hospital
name: Hae Keum Kil, PH.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02513628: Optic Nerve Sheath Diameter for Prediction of Outcome After Cardiac Arrest
Official title: The Optic Nerve Sheath Diameter for Prediction of Outcome After Cardiac Arrest: a Pilot Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: Cardiac arrest
neuroprognostication
optic nerve sheath diameter
outcome
ultrasonography
Lead sponsor: Hopital of Melun
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 36
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: All unconscious (Glasgow Coma Scale ≤6) patients ≥18 years old, admitted in ICU after successful resuscitation from CA, and treated with TH targeted to 33°C were screened. Exclusion criteria were as follows: unavailable ONSD measurement within 24 hours after return of spontaneous circulation (unavailable investigator, early death, or major hemodynamic instability), traumatic or neurological origin of CA, previous cerebrovascular disease, facial trauma affecting the orbits and/or eyeballs, and previous history of ocular pathology such as exophthalmia, glaucoma or cataract.

Brief summary: Early prognostication in resuscitated cardiac arrest (CA) patients, within the first day after admission in the intensive care unit (ICU), remains difficult. Optic nerve sheath diameter (ONSD) measurement could predict increased intracranial pressure. Preliminary works showed that ONSD measurement could be used to predict outcome in post-CA patients.

The aim of this study was to assess the ability of bedside ONSD ultrasonographic measurement to predict survival and Cerebral Performance Category (CPC) score at hospital discharge in post-cardiac arrest patients treated with therapeutic hypothermia (TH).

Detailed description: Prospective observational study including all consecutive successfully resuscitated and TH-treated CA patients without traumatic or neurological etiology of CA in two French ICUs. ONSD measurements were performed on day 1, 2, and 3 after return of spontaneous circulation (ONSD1,2,3 respectively).

The primary outcome is survival at hospital discharge (with an average follow-up of 3 month until ICU admission).

Eligibility criteria: Inclusion Criteria:

* Unconscious (Glasgow Coma Scale ≤6)
* ≥18 years old
* Admitted in ICU after successful resuscitation from CA
* Treated with TH targeted to 33°C

Exclusion Criteria:

* unavailable ONSD measurement within 24 hours after return of spontaneous circulation (unavailable investigator, early death, or major hemodynamic instability)
* Traumatic or neurological origin of CA
* Previous cerebrovascular disease
* Facial trauma affecting the orbits and/or eyeballs
* Previous history of ocular pathology such as exophthalmia, glaucoma or cataract.

Primary outcomes:
measure: In-hospital mortality
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00177528: Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major Depression
Official title: Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Keywords: Elderly
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study is to evaluate the safety and usefulness of venlafaxine-XR in the treatment of major depression in the elderly.

Detailed description: The primary objective of this pilot study is to evaluate the safety of venlafaxine extended release formulation (XR) in the treatment of geriatric non-psychotic depression. This pilot study's specific aims are to assess the safety of venlafaxine XR in the geriatric population, to estimate the response rate of older depressed subjects treated under open conditions and to evaluate pharmacokinetic characteristics that may impact on safety and outcome.

Eligibility criteria: Inclusion Criteria:

* men and women of all races who are 60 years old or older;
* a DSM-IV diagnosis of major depressive episode without psychotic features;
* 17-item Ham-D score of \>15 for potential subjects who have not received any antidepressant treatment during this illness episode or HAM-D \> 11 for potential subjects who have received treatment with an antidepressant (other than venlafaxine-XR) during this illness episode;
* a MMSE score of \>15.

Exclusion Criteria:

* history of meeting DSM-IV criteria for mania, schizophrenia or other psychotic disorder;
* history of substance abuse or dependence, including alcohol, within the last three months;
* current hyponatremia (as defined as a serum sodium level \< 130 meq/l);
* untreated or uncontrolled hypertension;
* a history of being unable to tolerate venlafaxine-XR or venlafaxine immediate release formulation;
* history of receiving venlafaxine-XR or venlafaxine immediate release formulation of 6 or more weeks at 300mg/d during index depressive episode; (7) EKG revealing QTc \> 480 msec;
* myocardial infarction, unstable angina, palpitation or cardiogenic syncope within 3 months prior to entering this study;
* the presence of active suicidal ideation with intent.

Primary outcomes:
measure: The safety and tolerability of venlafaxine XR.
measure: Rate of Major Depression remission to treatment.
Secondary outcomes:
measure: Participant characteristics that influence safety and remission rate.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ellen M Whyte, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Benoit H Mulsant, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Charles F. Reynolds III, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06724328: Maternal Heartbeat Sounds and Therapeutic Touch on Heart Rate,Comfort and Behavior in Newborns
Official title: Maternal Heartbeat Sounds and Therapeutic Touch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comfort
Behavior
Heart Rate
Keywords: Newborn, therapeutic touch, maternal heart, behavior
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 120
Sex: ALL
Minimum age (years): 32
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled study aims to evaluate the effects of maternal heartbeat sounds and gentle human touch (GHT), a form of therapeutic touch, on heart rate, comfort, and behavioral scores in neonates born between 32 and 40 weeks and admitted to the neonatal intensive care unit (NICU).

Detailed description: This parallel, randomized controlled trial will be conducted in the Neonatal Intensive Care Unit of a regional hospital. The sample will consist of 120 neonates with gestational ages of 32 to ≤40 weeks and randomly assigned to four groups (maternal heart sound, therapeutic touch, maternal heart sound + therapeutic touch, and control group). The data of the study are the Newborn Information Form, the Anderson Behavioral Status Scoring System, and Newborn Comfort Behavior Scale. Demographic data will be compared between groups (maternal heartbeat sound group (Group 1), light human touch group (Group 2), combined maternal heartbeat sound and light human touch group (Group 3), and control group (Group 4)). Video recordings will be used to compare heart rate, behavioral status, and comfort scale scores obtained before, during, and after the interventions. The time it takes to fall asleep will also be evaluated. A t-test will be applied to evaluate the score differences between groups.

Eligibility criteria: Inclusion Criteria:

* • Newborns between \>32 and ≤40 weeks gestational age.

  * Admission to neonatal intensive care unit (NICU) after birth.
  * Parental consent form obtained.

Exclusion Criteria:

* • Absence of neurological and cardiac problems.

  * No use of corticosteroids.
  * No use of muscle relaxants.
  * Not past the postnatal 10th day.
  * Not receiving non-invasive or invasive respiratory support.

Primary outcomes:
measure: comfort
timeFrame: 0 minutes (pre-intervention), 5 minutes, 15 minutes, and 20 minutes (post-intervention)
Secondary outcomes:
measure: behavior
timeFrame: 0 minutes (pre-intervention), 5 minutes, 15 minutes, and 20 minutes (post-intervention)
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
References:
Clinical trial NCT06391528: Transversalis Fascia Plane Block in Pediatric Patients
Official title: Effects of Transversalis Fascia Plane Block in Pediatric Patients Undergoing Inguinal Hernia and Orchiopexy Surgeries
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Regional Anesthesia
Parental Satisfaction
Keywords: postoperative pain
pain scores
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: to investigate the effects of Transversalis Fascia Plan Block after induction of anesthesia on perioperative opioid consumption, hemodynamic changes, postoperative FLACC pediatric pain score, non-opioid analgesic use and parental satisfaction in pediatric patients undergoing unilateral inguinal hernia or undescended testicular repair under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* 1-9 years old
* ASA I-II risk group
* Patients whose consent was obtained from their parents with an informed consent form
* Patients who will undergo Inguinal Hernia or Undescended Testi

Exclusion Criteria:

* ASA \>2
* History of allergy to local anesthetics
* Known coagulation disorders
* Infection near the entry site
* Body mass index \>30
* Those whose parents refused to participate in the study
* Those contraindicated for regional anesthesia
* Those with neurological or neuromuscular disease
* Patients with psychiatric problems
* Patients with a history of opioid use
* Chronic analgesic use
* Operation duration exceeding 2 hours

Primary outcomes:
measure: postoperative pain scores
timeFrame: up to 24 hour after surgery
Secondary outcomes:
measure: parental satisfaction
timeFrame: during the procedure
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University medicine faculty
state: Kozlu
Study officials:
References:
Clinical trial NCT05471128: MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Official title: MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy for the Detection of Clinically Significant Prostate Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will cover all races, including socioeconomically disadvantaged minorities, that have been diagnosed with prostate cancer.

Brief summary: The purpose of this study is to find out how best to detect clinically significant lesions of prostate cancer by using micro-ultrasound technology (ExactVu) and by multiparametric magnetic-resonance imaging (mpMRI).

Detailed description: This is a pilot clinical trial with 30 patients with either: 1) suspected prostate cancer (based on elevated PSA or abnormal digital rectal exam (DRE), or 2) known low-risk prostate cancer being managed with active surveillance.

Enrolled patients will undergo MRI fusion biopsy and standard-template 12 core TRUS biopsy as the standard-of-care. Patients will also undergo micro-ultrasound evaluation and targeted biopsy if lesions are identified. Detection rates of clinically significant lesions by ExactVu and by MRI will be compared.

Eligibility criteria: Inclusion Criteria:

1. Patients scheduled to undergo biopsy and with one of the following:

   * Men with suspicion of prostate cancer
   * Men on active surveillance
2. Age ≥18 \[30\]
3. Have available multiparametric prostate MRI
4. Able to provide written, informed consent
5. No significant medical illness which in the opinion of the Investigator would preclude entry to study procedures
6. Be willing and able to comply with scheduled visits

Exclusion Criteria:

1. Previously confirmed prostate cancer diagnosis with Grade Group \>= 2
2. Unable to undergo prostate biopsy
3. Prostate MRI unable to be evaluated using the PI-RADS v2 criteria
4. Men with contraindication for MRI or a prostate biopsy
5. Prostate biopsy within 8 weeks prior to mpMRI.
6. Any history of prostate treatment

Primary outcomes:
measure: Detection Rate
timeFrame: 2 years
measure: Feasibility of ExactVu
timeFrame: 2 years
Secondary outcomes:
measure: Predictive Performance Measures
timeFrame: 2 years
measure: Predictive Performance Measures
timeFrame: 2 years
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center, Stephenson Cancer Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma Stephenson Cancer Center
name: Andrew McIntosh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00559728: Magnetic Resonance Imaging (MRI) Analysis of Coronary Artery Plaque Components
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Plaque Components
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2007-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and Females 18 - 65 scheduled to undergo a clinically-indicated coronary artery CT scan.

Brief summary: The purpose of this study is to analyze atherosclerotic vessel wall components with multidetector computed tomography (MDCT) and compare with MRI. The hypothesis is that MRI is comparable to computed tomography (CT) in showing plaque components of coronary plaques.


Eligibility criteria: Inclusion Criteria:

* Adult males and females 18 - 65 who are scheduled to undergo a CT scan for evaluation of coronary artery plaque.

Exclusion Criteria:

* Contraindications to having an MRI scan
* Pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: David A. Bluemke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05919628: Psychological Ressources, Anxiodepressive Symptoms, Well-being and Therapeutical Observance in Parkinson's Disease
Official title: Psychological Ressources as a Protective Factor for Anxiety-depression, Well-being and Therapeutical Observance in Parkinson's Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: psychological ressources
well-being
depression
anxiety
therapeutical observance
parkinson's disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's disease patients at any stage of the disease.

Brief summary: Anxiodepressive symptoms are frequently observed in Parkinson's disease patients. These non motor psychiatric charateristics of the disease negatively impairs quality of life, and may impair well-being or therapeutical observance.

The objective of this study is to determine if psychological ressources are associated to anxiodepressive symptoms, to parkinson well-being and therapeutical observance. It will be interesting to determine if the presence of some - or multiple- psychological ressources could prevent patients from anxiety, depression, impaired well-being and impaired observance.

This study will analyse retrospectively psychological scalescompleted by 30 parkinson's disease patients through previous psychological interviews. The scales investigate anxiety, depression, well-being, psychological ressources, and therapeutical observance.

The results will highlight the importance of working on psychological ressources with Parkinson's disease patients through psychotherapy, in order to improve their well-being, positive emotions and maybe contribute to better therapeutical observance.

Detailed description: The scales used are :

* The SPANE
* The PAS
* The LOT-R
* The SCS
* The brief BDI
* The SSAM
* The HAD
* The MAAS
* An observance scale

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of Parkinson's disease

Exclusion Criteria:

* Patients with any other parkinsonian syndrome

Primary outcomes:
measure: Study of the links between psychological ressources and anxiodepressive symptoms
timeFrame: At baseline
Secondary outcomes:
measure: Study of the links between therapeutical observance and anxiodepressive symptoms
timeFrame: At baseline
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHU de Nancy
Study officials:
References: