louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01125904: A Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers
Official title: A Study In Trained Taste Panel Healthy Adult Volunteers To Investigate The Palatability Of Select Formulations Of Crizotinib Oral Liquid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Crizotinib
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-05-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: An oral-liquid, pediatric form of crizotinib designed for use by pediatric patients is being tested for its' palatability in adults.

Detailed description: Taste assessment of new formulation. Subjects will not ingest the drug.

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 75 years, inclusive.
* Subjects must be trained sensory panelists.
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, product evaluations, laboratory tests, and other study procedures.

Exclusion Criteria:

* A history of clinically significant hematological, renal, endocrine, pulmonary , glaucoma, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease (excluding untreated, asymptomatic seasonal allergies at the time of product evaluation) as evaluated through a medical history.
* A history of hypersensitivity to any inactive ingredients employed in the formulation(s).
* Receiving treatment with an investigational drug within 28 days preceding any of the product evaluations for this study.
* Participation in a product taste evaluation (ie, 'sip and spit' type taste evaluation) involving an active pharmaceutical ingredient (API) within 5 half lives of that API.
* Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.

Primary outcomes:
measure: A complete description of the sensory attributes of drug product prototype formulations (eg, aroma, flavor, texture, and mouthfeel).
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Woburn
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01881204: Hesperidin and Bone Health in Postmenopausal Women
Official title: Hesperidin and Bone Health in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis, Postmenopausal
Keywords: Hesperidin
Osteoporosis
Bone Loss
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Nestec Ltd.
First posted: 2013-06-19
Enrollment: 12
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary objective of this clinical trial is to test hesperidin with and without CALCILOCK® for bone resorption suppressing effect in postmenopausal women. The secondary objective is the comparison between 41Ca technology and classical biomarker to evaluate bone resorption.

Detailed description: Subjects will participate in four phases of the study: Baseline of 50 days and three intervention phases which include 50 days receiving product followed by 50 days of recovery. The total duration of the study will be 350 days. If participant has not been previously labeled with 41Ca, a 150 day period is added to the study.

Hesperidin (552mg) and Calcilock® (amount per day: Calcium: 684 mg; Phosphorus: 282mg; Magnesium: 102mg; Zinc: 2.86mg; Vitamin C: 20 mg; Vitamin K1: 28µg; Vitamin D: 1.86µg) will be administered in the form of cookies (biscuit).

Eligibility criteria: Inclusion Criteria:

* Women at least 4 years postmenopausal

Exclusion Criteria:

* Medications affecting bone resorption

Primary outcomes:
measure: Elimination of 41Calcium in Urine.
timeFrame: 50 days
Secondary outcomes:
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Connie M Weaver, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Purdue University
name: Berdine R Martin, PhD
role: STUDY_DIRECTOR
References:
citation: Martin BR, McCabe GP, McCabe L, Jackson GS, Horcajada MN, Offord-Cavin E, Peacock M, Weaver CM. Effect of Hesperidin With and Without a Calcium (Calcilock) Supplement on Bone Health in Postmenopausal Women. J Clin Endocrinol Metab. 2016 Mar;101(3):923-7. doi: 10.1210/jc.2015-3767. Epub 2016 Jan 11.
Clinical trial NCT01210404: Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance
Official title: Open Label Single Sequence Study To Estimate The Effect Of Filibuvir (PF-00868554) On S-And R-Methadone In Subjects Receiving Chronic Methadone Treatment And To Evaluate The Pharmacokinetics Of Filibuvir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Keywords: Drug interaction with methadone.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C infection. Given the likelihood of co administration of filibuvir and methadone, this study will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.


Eligibility criteria: Inclusion Criteria:

* Males or females, without evidence of infection with HIV,HBV or HCV, who are on chronic methadone maintenance for at least three months and at a stable dose for at least 1 week prior to study start.

Exclusion Criteria:

* Evidence of chronic diseases including HIV, HBV or HCV.
* Evidence of acute or chronic liver disease.
* Treatment with prescription or nonprescription drugs other than methadone within 7 days.

Primary outcomes:
measure: Methadone plasma pharmacokinetic parameters, AUC24, Cmax
timeFrame: day 1
measure: Methadone plasma pharmacokinetic parameters, AUC24, Cmax
timeFrame: day 11
Secondary outcomes:
measure: Methadone plasma pharmacokinetic parameters Tmax and C24h
timeFrame: day 1
measure: Methadone plasma pharmacokinetic parameters Tmax and C24h
timeFrame: day 11
measure: Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.
timeFrame: day 2
measure: Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.
timeFrame: day 11
measure: Safety and tolerability, including adverse events, vital signs, 12 lead ECG and lab safety assessments.
timeFrame: days 0-12
measure: Symptoms of methadone withdrawal as assessed by short Opiate Withdrawal Scale, Desires for Drug questionnaire and pupillary diameter measurement .
timeFrame: days 0-12
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01285804: Impact of Using a Cuffed Endotracheal Tube on Limiting the Risk of Airway Fire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoidectomy
Tonsillectomy
Adenotonsillectomy
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2011-01-28
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the impact of using a cuffed endotracheal tube (ETT) on the oxygen concentration in the oropharynx during adenoidectomy, tonsillectomy, or adenotonsillectomy. The study hypothesis is that inflation of the cuff on the ETT will eliminate contamination of the oropharynx with the inspired anesthetic gases and decrease the oxygen concentration in the oropharynx.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing adenoidectomy, tonsillectomy, or adenotonsillectomy.

Exclusion Criteria:

* Airway anomalies or cardiac conditions that have the potential for a complicated anesthesia induction.

Primary outcomes:
measure: Difference in oxygen concentration in the oropharynx between cuffed and uncuffed ETT.
timeFrame: 4-5 minutes after induction
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT03135704: Comparison of Two Treatments for Low Back Pain: "Re Spine" vs. Physiotherapy
Official title: Comparison of Two Treatments for Low Back Pain: "Re Spine" vs. Physiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-05-01
Enrollment: 60
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 objective of this study is to assess the effectiveness of the "Re Spine" mattress, which was designed as an alternative to physiotherapy in the treatment of low back pain (LBP).


Eligibility criteria: Inclusion Criteria:

* Low back pain

Exclusion Criteria:

* None

Primary outcomes:
measure: Reduction in low back pain
timeFrame: 1 day, 6 weeks, 3 months
measure: Effectiveness of treatment
timeFrame: 1 day, 6 weeks, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Eyal Behrbalk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03317704: Regulation of Metabolism and Ion Handling
Official title: Regulation of Metabolism and Ion Handling - Effect of High Intensity Training and NAC-infusion in Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the relation between ion-handling (K+) and fatigue development during exercise. Before and after a 6-week period of high intensity interval training, performance and ion-handling is assessed in young adults. In addition, mitochondrial function is examined.


Eligibility criteria: Inclusion Criteria:

* Healthy men
* 45-55 ml/kg/min
* BMI 19-26 kg/m2
* Normal ECG (assessed by MD)

Exclusion Criteria:

* Allergic to n-acetylcystine (NAC) or digoxin
* Severe side effects from NAC or digoxin
* Chronic diseases (assessed by MD to be a potential hazard or to interfere with outcome measures)

Primary outcomes:
measure: Quadriceps endurance
timeFrame: Change from before (baseline) to after 6 weeks of training (Week 6)
Secondary outcomes:
measure: K+ release
timeFrame: Change from before (baseline) to after 6 weeks of training (Week 6)
Other outcomes:
measure: Femoral venous plasma K+
timeFrame: Change from before (baseline) to after 6 weeks of training (Week 6)
measure: Femoral venous lactate
timeFrame: Change from before (baseline) to after 6 weeks of training (Week 6)
measure: Muscle Na+/K+-ATPase subunit content
timeFrame: Change from before (baseline) to after 6 weeks of training (Week 6)
measure: Muscle mitochondrial respiration
timeFrame: Change from before (baseline) to after 6 weeks of training (Week 6)
measure: Muscle mitochondrial content
timeFrame: Change from before (baseline) to after 6 weeks of training (Week 6)
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
References:
Clinical trial NCT06747104: Application of Manual Therapy to Archers
Official title: Assessment of Upper Limb Muscle Activity and the Effect of Manual Therapy on Fatigue, Stiffness and Muscle Activity During Training
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: archery
muscle fatigue
recovery
manipulation
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to: (i) characterize the effect of repeated archery shots on the EMG parameters of certain selected upper limb muscles; and (ii) evaluate how manipulation of the initial two-second tension phase, in particular involving muscle stretching, affects these EMG parameters after repeated shots.

Detailed description: EMG measurements will be collected for selected muscles in the shoulder joint and forearm, at points: initially at the beginning, after the athletes have performed 50 and another 50 archery shots, and finally after undergoing manual therapy. The main phase of muscle testing will take place in the Aiming phase.

Eligibility criteria: Inclusion Criteria:

* Actively training as an archer at least twice a week for six months;
* In good health, with no recent injury or illness;
* Over 18 years of age;
* Engagement in all phases of the study.

Exclusion Criteria:

* Any injury or illness present at the time of the study;
* Recent history (within six months) of upper extremity injury (shoulder, elbow, or wrist), joint pain, lower extremity joint hypermobility, or neurological/connective tissue disease.
* No training participation
* No consent for study

Primary outcomes:
measure: Assessment of MVC.
timeFrame: Each isometric muscle test lasts 3 seconds. The study is performed three times for each muscle.
measure: Muscle stiffness
timeFrame: Each Myoton application lasts 1 sec for one point. Three evaluations of one of the two points for one muscle are performed. It is assumed that the study with recording will last 30 seconds for one muscle.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Gdansk
name: Rafał Studnicki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00452504: Single Ascending Dose Study of SRA-444 in Healthy Subjects
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SRA-444 Administered Orally to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-27
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a first-in-humans study of SRA-444. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SRA-444 (SR formulation) after administration of ascending single oral doses to healthy adult subjects.


Eligibility criteria: Inclusion criteria:

* Healthy men or women of nonchildbearing potential aged 18 to 50 years,
* Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.

Exclusion criteria:

* Family history of sudden death and/or QT prolongation.
* An automatic ECG corrected QT (QTc) interval reading at screening \>450 ms and \>470 ms for male and female subjects, respectively.
* Sinus bradycardia at screening, defined as a resting heart rate ≤45 bpm. Resting supine blood pressure at screening \<110 mm Hg (systolic) and/or \<60 mm Hg (diastolic).

Primary outcomes:
measure: Assessment of the safety and tolerability of SRA-444
Secondary outcomes:
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Netherlands, trials-NL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05556304: In Vivo Evaluation of Perineal Mechanical Properties During Childbirth
Official title: In Vivo Evaluation of Perineal Mechanical Properties During Childbirth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perineum; Rupture
Perineum; Tear
Perineal Tear
Keywords: perineal tear
hyperelasticity
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, longitudinal and single-center study
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.

Detailed description: The objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.

Eligibility criteria: Inclusion Criteria:

* Pregnant and volunteer women \>18 years old
* Primiparous
* With a singleton pregnancy
* No objection from the subject and the spouse to participate in the study

Exclusion Criteria:

* History of prior delivery or c-section
* History of perineal troubles
* BMI \> à 35 mg/m²
* History of chronic muscular disease or connective tissue pathology
* Psychiatric pathology requiring hospitalization
* Patients who do not understand the French language
* Legal incapacity or limited legal capacity
* Patients unlikely to cooperate

Primary outcomes:
measure: maximum value of equivalent deformation obtained by stereovision camera
timeFrame: delivery
Secondary outcomes:
measure: Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB
timeFrame: pregnancy
measure: Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB
timeFrame: delivery
measure: Correlation between perineal deformation values and perineal tears
timeFrame: delivery
measure: Correlation between perineal deformation values and fetal parameters
timeFrame: pregnancy
measure: Correlation between perineal deformation values and fetal parameters
timeFrame: delivery
measure: Correlation between fetal ultrasound and neonatal parameters and perineal tears
timeFrame: delivery
measure: Evolution of the elasticity of the perineal body and the SAE during delivery
timeFrame: delivery
measure: Correlation between elasticity of the perineal body and perineal tears
timeFrame: pregnancy
measure: Correlation between elasticity of the perineal body and perineal tears
timeFrame: delivery
measure: Correlation between the elasticity of the external anal sphincter and perineal tears
timeFrame: pregnancy
measure: Correlation between the elasticity of the external anal sphincter and perineal tears
timeFrame: delivery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02858804: EDOCH Alternating With DHAP for New Diagnosed Younger MCL
Official title: EDOCH Alternating With DHAP Regimen Combined Rituximab or Not to Treat New Diagnosed Younger (Age≤65 Years) Mantle Cell Lymphoma in China: A Multicentre Phase III Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mantle Cell Lymphoma
Keywords: mantle cell lymphoma
EDOCH
DHAP
maintenance therapy
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to:

1. determine the efficiency of EDOCH (etoposide,dexamethasone,doxorubicin, cyclophosphamide and vincristine) alternating with DHAP (cisplatin, cytarabine and dexamethasone) regimen combined with rituximab or not in young mantle cell lymphoma patients (age≤65 years);
2. determine the efficiency of rituximab and thalidomide plus prednisone as maintenance regimens.

Detailed description: Enrolled patients will receive EDOCH (etoposide,dexamethasone,doxorubicin, cyclophosphamide and vincristine) ±R /DHAP(cisplatin, cytarabine and dexamethasone) ±R alternating chemotherapy. If a partial remission or better response achieves, patients will be recommended to receive autologous stem cell transplantation as consideration therapy or another two cycles EDOCH ±R /DHAP±R chemotherapy (based on patient's choice). Patients with less than partial remission (PR) response will quit this study. After treatments finished, maintenance therapy with rituximab or thalidomide plus prednisone will be given less than two years. The determination of maintenance regimens is dependent on patients choices.

Eligibility criteria: Inclusion Criteria:

* age≤65 years
* diagnosis with mantle cell lymphoma
* Ann Arbor stage II,III or IV
* ECOG≤1 or if ECOG≥2 but recover after pretreatment.

Exclusion Criteria:

* with centre neural system involvement
* serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician
* HIV positive or active HBV infection or other uncontrolled systematic infection
* clinical central nervous dysfunction
* serious surgery within 30 days
* pregnancy or baby nursing period or un-contracepted child bearing period woman.

Primary outcomes:
measure: progression free survival
timeFrame: up to 36 months
Secondary outcomes:
measure: complete remission
timeFrame: up to 6 months
measure: overall survival
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Shuhua Yi
Study officials:
affiliation: Blood disease hospital, Chinese Academic Medical School
name: Shuhua Yi, Doc
role: PRINCIPAL_INVESTIGATOR
References: