louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03762928: ESTIMATION OF THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ
Official title: A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ IN HEALTHY PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: PK
Phase 1
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-12-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The current study will estimate any inhibitive or inductive effect of PF-06651600 on the pharmacokinetics of midazolam and efavirenz.


Eligibility criteria: Inclusion Criteria:

Male and female participants who are healthy Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease
* Any condition possibly affecting drug absorption
* Known immunodeficiency.
* Infection with hepatitis B or hepatitis C viruses
* acute or chronic infections or infection history judged to be clinically significant by the investigator
* History of any lymphoproliferative disorder
* known present or a history of malignancy other than a successfully treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
* live (attenuated) vaccines within 6 weeks prior to the first dose of investigational product.

Primary outcomes:
measure: single dose Area under the curve at last quantifiable infinity time of midazolam
timeFrame: Hour 0, 0,5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose
measure: Single dose Area under the Curve from time 0 to 72 hours post-dose of efavirenz
timeFrame: hour 0, 0,5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose
Secondary outcomes:
measure: number of subjects with significant change from baseline in vital signs
timeFrame: hour 0 on study days 1, 4, 10 and 13 post-dose
measure: number of subjects with significant change from baseline in laboratory safety tests results
timeFrame: study days -1, 4, 13 post-dose
measure: number of subjects with treatment emergent adverse events (TEAE)
timeFrame: Baseline up to 35 days post dose
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00006428: Chronic Pain in Spinal Cord Injury
Official title: Management of Chronic Pain in Rehabilitation Project I - Management of Chronic Pain in Persons With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Cord Injuries
Pain
Keywords: Spinal Cord injury (SCI)
Chronic Pain
Amitriptyline
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2000-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial tests the effectiveness of the drug amitriptyline vs placebo to relieve chronic pain in adults that have had a spinal cord injury.

Detailed description: This double masked placebo-controlled trial will randomize patients (n=100) with a greater than 6 month history spinal cord injury and a greater than 3 month history of associated pain to a daily dose of amitriptyline or placebo for 6 weeks. Patients will be examined before randomization by a study physician or nurse masked to their treatment assignment. They will be assessed by telephone interview before, during treatment, at the end of treatment and 4 months later to assess pain, pain interference with activities, physical and mental health, and number of health care visits for pain.

Eligibility criteria: Inclusion Criteria:

* Spinal Cord Injury six months ago or longer
* Pain for 3 months or longer

Exclusion Criteria:

* History of cardiovascular disease, seizures, or glaucoma
* Currently taking antidepressant medications
* Currently hyperthyroid or taking thyroid medicine
* Currently pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington, Department of Rehabilitation Medicine
state: Washington
Study officials:
affiliation: University of Washington, Department of Rehabilitation
name: Diana Cardenas, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leijon G, Boivie J. Central post-stroke pain--a controlled trial of amitriptyline and carbamazepine. Pain. 1989 Jan;36(1):27-36. doi: 10.1016/0304-3959(89)90108-5.
citation: Max MB, Culnane M, Schafer SC, Gracely RH, Walther DJ, Smoller B, Dubner R. Amitriptyline relieves diabetic neuropathy pain in patients with normal or depressed mood. Neurology. 1987 Apr;37(4):589-96. doi: 10.1212/wnl.37.4.589.
citation: Sandford PR, Lindblom LB, Haddox JD. Amitriptyline and carbamazepine in the treatment of dysesthetic pain in spinal cord injury. Arch Phys Med Rehabil. 1992 Mar;73(3):300-1.
citation: Cardenas DD, Warms CA, Turner JA, Marshall H, Brooke MM, Loeser JD. Efficacy of amitriptyline for relief of pain in spinal cord injury: results of a randomized controlled trial. Pain. 2002 Apr;96(3):365-373. doi: 10.1016/S0304-3959(01)00483-3.
Clinical trial NCT00779428: Clinical Trial of Continuing Treatment for Patients Who Have Participated on a Prior Protocol Investigating Tanespimycin
Official title: Phase 2 Clinical Trial of Tanespimycin in Patients With Advanced Malignancies After Failure of Previous Anti-cancer Therapy Regimens Who Have Participated on a Prior Protocol Investigating Tanespimycin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Malignancies
Keywords: This is an open-label continuing treatment protocol in patients with advanced malignancies who will receive Tanespimycin
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to provide treatment to patients who have participated on a prior protocol investigating Tanespimycin (KOS-953,17-AAG)


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Participated in and completed a previous Tanespimycin protocol without evidence of unacceptable toxicity and is deemed by the Investigator to be deriving benefit from the Tanespimycin drug as defined in the previous protocol
* All patients must rollover to this continuation protocol within 30 days of the last dose of Tanespimycin in the previous protocol, unless previously approved by the Medical Monitor
* All Adverse Events from the prior protocol, must have resolved to NCI CTCAE (v. 3.0) Grade \<= 2
* The following laboratory results, within 10 days of Tanespimycin administration:
* Hemoglobin \>= 8 g/dL
* Absolute neutrophils count \>= 1.0x 10\*9\* /L
* Platelet count \>= 50 x 10\*9\* /L
* Serum bilirubin \<= 2 x ULN
* AST \<= 2.5 ULN
* Serum creatinine \<= 2 x ULN
* ECOG performance status of 0, 1 or 2
* Signed informed consent

Exclusion Criteria:

* Pre-existing neuropathy of CTCAE Grade \>= 3 due to any cause
* Documented hypersensitivity reaction of CTCAE Grade \>= 3 to prior therapy containing Cremophor (for those patients receiving Tanespimycin Injection)
* Pregnant or breast-feeding women
* Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic), excluding Tanespimycin within 21 days prior to receipt of study medication
* Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient

Primary outcomes:
measure: There is no Primary Outcome
timeFrame: No formal analysis of efficacy will occur
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05900128: Impact of Exercise on Ashtma in Adults
Official title: Impact of Exercise on Asthma Control and Management in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Physical Inactivity
Keywords: asthma
sedentarism
spirometry
physical excercise
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate if physical activity could improve asthma control and management in adults. With this purpose we enroll asthmatic patients between 18-64 years old, and randomized them into 2 groups: in the first, patients will receive some workshops about asthma en physical exercise; in the second no educational intervention will be done. All patients will use a step counter in order to evaluate their activity during the study. Spirometric values and questionnaries about asthma control and quality of life will be recorded for all patients. Finally 2 groups will be comparated in order to search any difference in quality of life and asthma control.

Detailed description: 52 asthmatic will be enrolled and randomized into 2 groups. All patients will send a weekly summary of their physical activity (mean number of steps and time of physical activity). All patients will be undergone to a medical visit at month 1 and 3 since study start. In each visit a spirometry, a FeNo, ACQ and AQLQ questionnaires will be done.

The patients of the intervention group will receive 3 workshops about asthma and physical exercise in order to provide information, medical support, and to resolve any question or difficulty about it. The workshops will be al week 1, 2 and 4 since study start.

Eligibility criteria: Inclusion Criteria:

* asthma well controlled
* sedentarism (\<150 min physical activity/day and/or \<7000 daily steps)

Exclusion Criteria:

* pregnancy
* cardiological, not well controlled deseases
* other cronic pulmonary deseases
* bad asthma control
* not sign IC
* unable to practice physical activity (for cognitive or physical conditions)
* no devices able to count steps and physical activity

Primary outcomes:
measure: Improvement of asthma control
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Móstoles
country: Spain
facility: Hospital Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Hospital Rey Juan Carlos-Instituto de Investigación FJD
name: sarah micozzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00141128: Evaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX.
Official title: Measurement Of Urethral Function In Women With Stress Urinary Incontinence - Evaluation Of The Sensitivity Of Urethral Reflectometry Compared To Urethral Pressure Profilometry, Using [S,S]-Reboxetine To Detect Pharmacological Augmentation Of Urethral Pressure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Incontinence, Stress
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 18
Sex: FEMALE
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: SS-RBX will be used to evaluate pharmacodynamic changes in urethral function using a novel methodology


Eligibility criteria: Inclusion Criteria:

* Female
* Stress urinary incontinence

Exclusion Criteria:

* Bladder outflow obstruction
* Neurological disease

Primary outcomes:
measure: To assess the utility of urethral reflectometry in the detection of pharmacologically induced pressure changes in the female urethra.
Secondary outcomes:
measure: To assess the effect of [S,S]-Reboxetine on urethral function in women with SUI.
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Klarskov N, Scholfield D, Soma K, Darekar A, Mills I, Lose G. Measurement of urethral closure function in women with stress urinary incontinence. J Urol. 2009 Jun;181(6):2628-33; discussion 2633. doi: 10.1016/j.juro.2009.01.114. Epub 2009 Apr 16.