louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00228397: Study Evaluating CCI-779 in Relapsing Multiple Sclerosis
Official title: A Multicenter, Randomized, Double-blind, Long-term Extension Study to Determine the Safety, Tolerability, and Preliminary Efficacy of CCI-779 in Subjects With Relapsing Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-28
Enrollment: 221
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of long-term therapy with 3 dose levels of oral CCI-779 administered to subjects with relapsing MS who completed study 3066A2-205-WW.


Eligibility criteria: Inclusion Criteria:

* Subjects with relapsing-remitting MS or secondary progressive MS with relapses.
* Successful completion of study 3066A2-205-WW with no major protocol violations.

Exclusion Criteria:

* Pregnancy or lactation.
* Clinically important abnormalities on the physical examination, vital signs, or electrocardiogram (ECG) performed at the last visit of study 3066A2-205-WW (day 252).
* Any adverse events or findings observed in study 3066A2-205-WW that in the opinion of the investigators would preclude the subject's entry into the extension study.

Please refer to section 16.2 'Discontinuation and Withdrawal of Subjects' regarding withdrawal of patients who have any clinical abnormalities in hematology or laboratory test results obtained at the last visit of the double-blind active phase of study 3066A2-205-WW.

Primary outcomes:
measure: Long-term safety.
measure: Listing and summary tables of AE and TEAEs, vital signs, laboratory evaluations, and ECG data will be generated.
Secondary outcomes:
measure: Preliminary efficacy of long-term treatment.
measure: Lesions observed on MRI scans, clinical measures such as the EDSS scale, the 9-Hole Peg Test, the Paced Auditory Serial Addition Test and the Timed Ambulation 25-Foot Test, occurrence of relapse, will be analyzed at end -point (12 or 16 months).
measure: Only descriptive statistics will be performed.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02486497: Adjuvant Gemcitabine Versus 5-FU/Leucovorin Based on hENT1 Immunostaining
Official title: Adjuvant Gemcitabine Versus 5-FU/Leucovorin Based on hENT1 Immunostaining After Curative Surgery of Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer
Adjuvant chemotherapy
hENT1
Gemcitabine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: IlDong Pharmaceutical Co Ltd
First posted: 2015-07-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Human equilibrative nucleoside transporter 1 (hENT1) is a membrane transporter which is a predicting marker for gemcitabine chemotherapy. However, there is a limited evidence of it as an indicator for adjuvant gemcitabine chemotherapy. In this study, investigators try to investigate the role of hENT1 as a indicator of selection of adjuvant chemotherapy regimen between gemcitabine and 5-fluorouracil (5-FU).

Detailed description: After surgical resection of pancreatic cancer, the tissue is immunostained by hENT1 antibody. The grades of immunostaining are categorized as 0 (0%), 1 (\<50%), and 2 (\>=50%). According to the grade, patients with grade 0 or 1 will be treated with 5-FU and those with grade 2 will be treated with gemcitabine. After the study, investigators will calculate the overall survival and recurrence free survival of the patients and investigate the role of hENT1 as a predictive biomarker for adjuvant gemcitabine chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Patients with curatively resected pancreatic cancer
* Age between 18 and 75
* Eastern Cooperative Oncology Group performance score 0 or 1
* Patients with compliance
* Patients with informed consent

Exclusion Criteria:

* Patients refuse to enroll this study
* Patients with concomitant chemoradiation therapy
* Previous chemotherapy
* Pregnant or preparing a pregnancy
* Uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarction within 6 months
* Enrolled another clinical trial within 30 days
* Patients will be expected to be risk because of enrollment
* Patients without informed consent

Primary outcomes:
measure: Recurrence free survival
timeFrame: Upto 24 weeks
Secondary outcomes:
measure: Overall survival
timeFrame: Upto 24 weeks
measure: Toxicity
timeFrame: Upto 24 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
citation: Shin DW, Lee JC, Kim J, Yoon YS, Han HS, Kim H, Hwang JH. Tailored adjuvant gemcitabine versus 5-fluorouracil/folinic acid based on hENT1 immunohistochemical staining in resected pancreatic ductal adenocarcinoma: A biomarker stratified prospective trial. Pancreatology. 2021 Jun;21(4):796-804. doi: 10.1016/j.pan.2021.02.022. Epub 2021 Mar 4.
Clinical trial NCT04159597: Expanded Access to Upadacitinib
Official title: Expanded Access to Upadacitinib
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Crohn Disease
Keywords: Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-11-12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria: Inclusion Criteria:

- The participant must not be eligible for upadacitinib clinical trial.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00173797: Comparison of Psychometric Properties of Three Depression Measures in Patients With Stroke
Official title: Comparison of Psychometric Properties of Three Depression Measures in Patients With Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Accidents
Keywords: depression
psychometrics
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2005-09-15
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: This study is going to comprehensively examine the psychometric properties of the three depression scales (Hamilton depression scale (HAMD), Hospital anxiety and depression scale (HADS), and Beck Depression Inventory (BDI)) in stroke patients over a period of three years.

Detailed description: This study is going to comprehensively examine the psychometric properties of the three depression scales (Hamilton depression scale (HAMD), Hospital anxiety and depression scale (HADS), and Beck Depression Inventory (BDI)) in stroke patients over a period of three years.

This study will be divided into two parts. In the first part, we will spend 3 years in recruiting 200 consecutive patients with a diagnosis of first stroke onset to compare the validity, responsiveness, and acceptability of the HAMD, HADS, and BDI. All patients will be assessed using the three depression scales and other functional measures at 14, 30, 90, 180, and 365 days after stroke.

In the second part, the inter-rater reliability of the three depression scales will be examined in the first year. Sixty chronic stroke patients will be recruited in the study.

Furthermore, the other 60 chronic stroke patients will be recruited in the second year for examining the test-retest reliability and measurement error of the three depression scales.

This study would be the first one to systematically compare the psychometric properties of the three depression scales in a long-term follow up study. The results of the study will be able to help clinicians and researchers select the most suitable depression scales for stroke patients. The results will also provide us references to develop a new depression scale, if needed, for stroke patients.

Eligibility criteria: Inclusion Criteria:

patients with a diagnosis stroke ability to complete questionnaires

Exclusion Criteria:

patients with other major diseases (e.g., cancer)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School of Occupational Therapy, College of Medicine, National Taiwan University
Study officials:
affiliation: School of Occupational Therapy, College of Medicine, National Taiwan University
name: Ching-Lin Hsieh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01476397: Probiotic Formula and Infant Growth
Official title: ASSESSMENT OF GROWTH OF INFANTS FED FORMULA WITH PROBIOTICS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: full-term
formula-fed infants
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2011-11-22
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes

Brief summary: This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups.


Eligibility criteria: Inclusion Criteria:

* Healthy newborn infant
* Full-term
* Birth weight \> 2500 and \< 4500 g
* 14±3 days of age on enrollment
* Exclusively formula-fed, singleton birth
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Known or suspected cow-milk allergy
* Congenital illness or malformation that may affect infant feeding and/or growth
* Significant prenatal and/or postnatal disease
* Any readmission to hospital prior to enrollment
* Receiving prescription medication or frequent use of over the counter medications except vitamin and mineral supplements
* Has received intravenous antibiotic therapy or oral probiotic in the last 7 days
* Currently participating in another clinical study
* Cannot be expected to comply with treatment

Primary outcomes:
measure: growth
timeFrame: 4 months
Secondary outcomes:
measure: other growth
timeFrame: 4 months
measure: adverse events
timeFrame: 4 months
measure: stool characteristics
timeFrame: throughout study
measure: spit-up
timeFrame: throughout study
measure: vomit
timeFrame: throughout study
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: North Scottsdale Pediatric Associates
state: Arizona
city: Marietta
country: United States
facility: Pediatrics & Adolescent Medicine
state: Georgia
city: Bardstown
country: United States
facility: Kentucky Pediatric Adult Research
state: Kentucky
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Bristol
country: United States
facility: PMG Research of Bristol
state: Tennessee
city: Tomball
country: United States
facility: Pediatric Healthcare of Northwest Houston
state: Texas
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
Study officials:
References:
Clinical trial NCT02833597: Claudication Evaluation During Rowing ExerciseS
Official title: Claudication Evaluation During Rowing ExerciseS. Rehabilitation Arteritis of Lower Limbs by Rowing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Keywords: peripheral artery disease
transcutaneous oxygen pressure
claudication
rowing ergometer
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-07-14
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with buttock pain and referred for an oximetry exercise test

Brief summary: Check the feasibility of the collection of reliable measures of tcpO2 the lower limbs in arteriopathy when performing rowing on effort.

Detailed description: Obtaining curve values of tcpO2 interpretable when recording the effort by rowing on rowing.

Show the occurrence of ischemia in the lower limbs during recording effort by rowing on rowing

Eligibility criteria: Inclusion Criteria:

* referred for an oximetry exercise test
* Patient able to walk on a treadmill
* Patient covered by the French health insurance
* Patient able to understand the protocol
* Patient agrees to be involve in the protocol and sign the consent form

Exclusion Criteria:

* any heart issues during the last 3 months
* pregnancy

Primary outcomes:
measure: Changes in transcutaneous oxygen pressure (tcpo2) value in the calf for different rowing intensities
timeFrame: up to 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: University hospital, Angers, FRANCE
name: Pierre ABRAHAM, MD; Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00792597: Comparison of Three Methods of Hemoglobin Monitoring
Official title: Comparison of Three Methods of Hemoglobin Monitoring in Patients Undergoing Spine Revision or Hip Revision Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Loss
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-11-18
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: See inclusion/exclusion criteria

Brief summary: The purpose of this study is to compare the hemoglobin results obtained with 1) the HemoCue™, 2) the Masimo SpHb™, and 3) the UCSF Clinical Laboratory. The goal is to determine if these three values differ from each other during various levels of blood loss in the clinical care of patients for spine revision and hip revision surgery.

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female 18 y/o or older
* American Society of Anesthesiology Classification 1, 2 or 3
* Scheduled to undergo spine or hip revision surgery

Exclusion Criteria:

* Pregnant or nursing
* Patients who in the study investigators clinical judgement would not be suitable for research.

Primary outcomes:
measure: See description below
timeFrame: A minimum of three differences recorded during surgery
Secondary outcomes:
measure: See description below
timeFrame: A minimum of three differences recorded during surgery
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ronald D Miller, MD
role: STUDY_DIRECTOR
References:
citation: Miller RD, Ward TA, Shiboski SC, Cohen NH. A comparison of three methods of hemoglobin monitoring in patients undergoing spine surgery. Anesth Analg. 2011 Apr;112(4):858-63. doi: 10.1213/ANE.0b013e31820eecd1. Epub 2011 Mar 8.
Clinical trial NCT00073697: Treatment of Depression in Adults
Official title: Depression: The Search for Treatment-Relevant Phenotypes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Keywords: Psychotherapy
Depressive disorder
Antidepressive agents
Citalopram
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-12-03
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will determine how certain features of depressed individuals affect their responses to depression treatment.

Detailed description: Major depression is a serious condition that can have devastating functional consequences. Although numerous depression studies have been conducted, understanding of how best to achieve long-term recovery remains limited. This study will assess the mood, personality, pharamcokinetic and genetic characteristics of depressed participants to determine the effects of these features on treatment response.

This study will be conducted at two international treatment sites, including the University of Pittsburgh and the University of Pisa, Italy. Participants will be randomly assigned to receive either interpersonal psychotherapy (IPT) or escitalopram pharmacotherapy for a minimum of 32 weeks or approximately 8 months. Participants whose symptoms become stabilized will continue the initial treatment for another 6 months; those who do not will have the second treatment added to their regimen until remission occurs. Clinical evaluations and questionnaires will be used to assess participants.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Major depression

Exclusion Criteria:

* History of manic or hypomanic episodes
* History of schizophrenia or schizoaffective disorder
* Diagnosis of anorexia nervosa or bulimia nervosa
* Current psychosis
* Drug and/or alcohol dependence or abuse within 3 months prior to study entry. Participants with episodic abuse related to mood disorders will not be excluded.
* Diagnosis of antisocial personality disorder
* Diagnosis of organic affective syndrome and uncontrolled medical illness
* Pregnancy
* Require inpatient treatment for suicidal risk or psychosis
* History of an inability to tolerate any of the study treatments
* Currently receiving treatment with an effective antidepressant

Primary outcomes:
measure: Hamilton Rating Scale for Depression score
timeFrame: Measured at Months 8 and 14
measure: Treatment-relevant phenotypes of depression
timeFrame: Measured at Months 8 and 14
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic - Depression Prevention Program
state: Pennsylvania
city: Pisa
country: Italy
facility: The University of Pisa
Study officials:
affiliation: University of Pittsburgh
name: Ellen Frank
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02244697: The Yield of Laryngeal Ultrasound in the Evaluation of Stridor and Dysphonia in Children
Official title: The Yield of Laryngeal Ultrasound in the Evaluation of Stridor and Dysphonia in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stridor
Vocal Cord Paralysis
Keywords: Stridor
Vocal Cord Paralysis (VCP)
Ultrasound (US)
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-09-19
Enrollment: 100
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children aged 0-16 years referred for an awake nasolaryngoscopy for stridor or dysphonia at the pediatric Otolaryngology unit at the Tel Aviv Sourasky Medical Centre will undergo US of the larynx.

Brief summary: Stridor is a respiratory noise caused by partial obstruction of the large airways at the level of the pharynx, larynx and/or trachea. The second most common cause of stridor is vocal cord paralysis.

Awake nasolaryngoscopyn (ANL) is regarded as the gold standard for the diagnosis of laryngomalacia. However, ANL has some drawbacks as it may cause discomfort for the patient and the laryngeal view may be obscured due to patient movement or anatomical variations.

Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging technique. Evaluation of the dynamic characteristics of the glottis by US revealed perfect reliability in comparison to nasolryngoscopy suggesting that US can be useful in the assessment of laryngeal adduction.

The investigator hypothesize that laryngeal US can be an accurate and reliable adjunct in the diagnosis of functional and anatomical causes of stridor and dysphonia in the pediatric population.


Eligibility criteria: Inclusion Criteria:

children aged 0-16 years referred for an awake nasolaryngoscopy for stridor or dysphonia at the pediatric Otolaryngology unit at the Tel Aviv Sourasky Medical Centre will undergo US of the larynx.

Exclusion Criteria:

* None

Primary outcomes:
measure: The number of participants that will be diagnosed with anatomical and functional causes of stridor and dysphonia by US in comparisom with ANL
timeFrame: 2014-2016
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Centre
Study officials:
name: Shirley Friedman, Doctor
role: PRINCIPAL_INVESTIGATOR
References: