louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01570244: Drug-drug Interaction of BI 201335 and Microgynon
Official title: An Open-label, Two-period, Fixed-sequence, Phase I Trial to Evaluate the Effect of Multiple Doses of 240 mg BI 201335 QD on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C, Chronic
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-04-04
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate possible effect of multiple oral doses of BI 201335 on the steady state pharmacokinetics of ethinylestradiol and levonogestrel


Eligibility criteria: Inclusion criteria:

1. Healthy female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: AUCt,ss of Ethinylestradiol
timeFrame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 hours (h) after drug administration
measure: Cmax,ss of Ethinylestradiol
timeFrame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration
measure: C24,ss of Ethinylestradiol
timeFrame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration
measure: AUCτ,ss of Levonorgestrel
timeFrame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration
measure: Cmax,ss of Levonorgestrel
timeFrame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration
measure: C24,ss of Levonorgestrel
timeFrame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration
Secondary outcomes:
measure: Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG.
timeFrame: from drug administration up to 14 days
measure: Number of Participants With Drug Related Adverse Events
timeFrame: from drug administration up to 14 days
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1220.56.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Sabo JP, Lang B, Elgadi M, Huang F. Effect of the hepatitis C virus protease inhibitor faldaprevir on the pharmacokinetics of an oral contraceptive containing ethinylestradiol and levonorgestrel in healthy female volunteers. Antimicrob Agents Chemother. 2015 Jan;59(1):514-9. doi: 10.1128/AAC.03589-14. Epub 2014 Nov 10.
Clinical trial NCT00587444: Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass
Official title: Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Hemorrhage
Keywords: heparin management
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2008-01-07
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study has been completed and is in the data analysis and manuscript writing phase of the project.


Eligibility criteria: Inclusion Criteria:

* Adult male and non-pregnant female patients scheduled for elective cardiac surgery requiring CPB will be eligible for enrollment.

Exclusion Criteria:

* Age less than 18 or greater than 90 years; emergency surgery
* Circulatory arrest
* Combined non-cardiac procedures such as carotid endarterectomy
* Congenital heart repair
* Off-CPB coronary artery bypass grafting (CABG)
* Clotting disorder
* Fibrinolytic agents (e.g. streptokinase), severe hepatic disease
* Aprotinin use
* Cooling \< 28 degrees C during CPB
* Dialysis dependent renal failure; and
* Platelet receptor GP3a/2b antagonists medication received within 48 hours of surgery. Patients that are not receiving tranexamic acid (TA) intraoperatively will be excluded.

Primary outcomes:
measure: measure blood loss
timeFrame: within 48 hours
Secondary outcomes:
measure: transfusion requirements
timeFrame: 48 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: William Oliver, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02771444: Low Dose Tomosynthesis Compared to Traditional Tomosynthesis
Official title: Low Dose Tomosynthesis Compared to Traditional Tomosynthesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Neoplasms
Lead sponsor: Philips Digital Mammography Sweden AB
Sponsor class: INDUSTRY
First posted: 2016-05-13
Enrollment: 17
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to evaluate image quality of a low-dose tomosynthesis system versus a comparator. Subjects will undergo a four-view tomosynthesis examination with the comparator and with the study device, and images will be assessed by several radiologists by comparing details in the images from the two systems.

Detailed description: Tomosynthesis is a relatively new technology to acquire mammographic images where images are acquired over several projection angles, giving 3d information that can help radiologists assess images.

The aim of the study is to see whether a new low-dose tomosynthesis system has comparable image quality at a lower x-ray radiation dose to a comparator.

Eligibility criteria: Inclusion Criteria:

* Woman over 40 years of age
* Has a tomosynthesis examination with comparator
* Has a mammographic finding

Exclusion Criteria:

* Pregnant, breastfeeding or believes she may be pregnant
* Unable or unwilling to give informed consent

Primary outcomes:
measure: X-ray dose
timeFrame: 4 months
Secondary outcomes:
measure: Lesion conspicuity comparison of images from study device vs comparator
timeFrame: 4 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale San Rafaele
Study officials:
affiliation: Ospedale San Raffaele
name: Pietro Panizza, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004344: Purification of Testis-Stimulating Factor in Precocious Puberty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Precocious Puberty
Keywords: endocrine disorders
precocious puberty
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Oregon Health and Science University
First posted: 1999-10-19
Enrollment: 4
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES:

Purify and characterize a testis-stimulating factor in the blood of adult volunteers who had precocious puberty as boys.

Detailed description: PROTOCOL OUTLINE: Subjects are treated for 2 months with depot injections of leuprolide acetate every 4 weeks and testosterone replacement every 2 weeks. Hormone levels are tested every other week.

If luteinizing hormone and follicular-stimulating hormone levels are at or below detection on day 56, blood is drawn for a testis-stimulating factor bioassay and subsequent factor purification and characterization.

Volunteers are asked to repeat this 2-month procedure no more than 2 times every 12 months.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

Adult men diagnosed with precocious puberty (familial testotoxicosis) as boys

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: Barry Albertson
role: STUDY_CHAIR
References:
Clinical trial NCT00214344: Family Preparation Study For Withdrawal of Mechanical Ventilation From Their Family Member
Official title: Evaluating the Usefulness of Preparing Families For Withdrawal of Mechanical Ventilation From Their Family Member: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mechanical Ventilation
Critically Ill
Keywords: dying
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Using the self-regulation theory, an intervention to prepare families for that experience was developed. This study will assess the impact of the intervention on a family's evaluation of their preparation and their short-term coping. The site used for this study will be the Trauma and Life Support Center (TLC), University of Wisconsin (UW) Hospital. After a decision has been made to withdraw life support, a member of the TLC staff will approach the next of kin of the patient to inform him/her about the study and inquire about his/her interest to participate. Using an experimental design, 10 family members will be assigned to the control group and 10 to the intervention group. Upon agreement, a research nurse will use a "coin toss method" for group assignment of the subjects until there are ten in each group. Experimental group subjects will receive the intervention after the family meeting. Demographics of the next of kin will be collected at this time. Patient information such as demographics, diagnosis, and time of withdrawal and death will be collected too. Two to four weeks after death, a telephone interview will be conducted with the next of kin using the "Evaluation of the Experience of Withdrawal" questionnaire and the Profile of Mood State - shortened version.

Potential benefits are that the families will be prepared for the experience of the dying patient, which will help them cope better during withdrawal and after their loss. There are no major risks to the subjects but there might be an increase in psychological distress.


Eligibility criteria: Inclusion Criteria:

* Next of kin of a patient who will have withdrawal of life support
* Participant must be 18 years of age or older and read, write, and speak English

Exclusion Criteria:

* Family is unusually highly emotional
* Patient will be a living donor
* Patient is conscious

Primary outcomes:
measure: Are the families who received education/counseling better prepared for the experience of the dying patient
Secondary outcomes:
measure: This is a feasibility Pilot Study
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Karin T Kirchhoff
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05081544: Impact of Multi-tasking Situations on the Dismounted Soldier's Cognitive Load
Official title: Impact of Multi-tasking Situations on the Dismounted Soldier's Cognitive Load
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognitive Load
Keywords: cognitive load
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be composed of healthy volunteers from several French infantry regiments (group leaders).

Brief summary: The increased complexity of the dismounted combatant's equipment can result in a strain on the various senses (e.g., visual, auditory) that can exceed an individual's limited information processing abilities. The combatant may thus be cognitively overloaded in multi-tasking operational situations.

There has been a great deal of research conducted on cognitive load. A battery of multitasking tests has been developed in the field of aeronautics, but, to our knowledge, no measurement of cognitive load specifically dedicated to combatants has been conducted yet.


Eligibility criteria: Inclusion Criteria:

* be a group leader in an infantry regiment,
* be over 18 years old.

Exclusion Criteria:

* be a woman,
* have a heart condition,
* have a visual disease not corrected by glasses or contact lenses,
* have a hearing score ≥ 2 on the SIGYCOP,
* have a psychiatric disorder, a progressive neurological or organic disease requiring drug treatment,
* take psychotropic drugs,
* take more than 28 units of alcohol per week.

Primary outcomes:
measure: Cognitive load level
timeFrame: At enrollment (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Brétigny-sur-Orge
country: France
facility: Institut de Recherche Biomédicale des Armées
Study officials:
References:
Clinical trial NCT03956992: Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque
Official title: Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: Dr. Kurt Wolff GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2019-05-21
Enrollment: 34
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this pilot study is to analyze if a hydroxyapatite-containing mouth gel has an influence on the calcium content of plaque.

Detailed description: \>= 20 subjects (7-11 years) use the hydroxyapatite-containing mouth gel for 3 days (3x per day); without using any other oral care product at this time. A dentist applies the gel on all teeth. At baseline and after 3 days plaque will be collected from buccal and labial surfaces (except surfaces with tartar). A "split-mouth" concept will be used:

Subjects in group A:

Baseline plaque collection: quadrant 1 and 4 Plaque collection after 3 days: quadrant 2 and 3

Subjects in group B:

Baseline plaque collection: quadrant 2 and 3 Plaque collection after 3 days: quadrant 1 and 4 (The time between last application of the gel and plaque collection will be 1 h) The plaque will be dried and afterwards the calcium content of the plaque will be quantitively analyzed by atomic absorption spectroscopy (AAS).

For all subjects: Calcium contents of plaque at baseline and after 3 days application will be compared by statistical methods.

Eligibility criteria: Inclusion Criteria:

* Girls and boys (7-11 years)
* Visible plaque
* \>= 4 teeth
* Good overall health

Exclusion Criteria:

* Allergic to one or more ingredients of the mouth gel
* Medication intake (e.g. antibiotics)
* Any other reason that, in the opinion of the investigator, disqualifies the subject from participating in the study

Primary outcomes:
measure: Calcium content of plaque
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bali
country: Indonesia
facility: Health department
state: Kebon Padangan
Study officials:
affiliation: Department for Dentistry, Health Care Center, Braunschweig, Germany
name: Henny Sudradjat
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shaw L, Murray JJ, Burchell CK, Best JS. Calcium and phosphorus content of plaque and saliva in relation to dental caries. Caries Res. 1983;17(6):543-8. doi: 10.1159/000260715. No abstract available.
Clinical trial NCT02807792: Perianal Operating Scope Feasibliity
Official title: Perianal Operating Scope Feasibility
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Transanal Endoscopic Surgery
Keywords: Perianal surgery
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This protocol will test a new prototype of a peri-anal access device, with increased flexible length and a captured operative field, for feasibility in patients immediately prior to their scheduled peri-anal procedure.

Detailed description: Research Methods: The insertion of the modified access device in five patients before their planned peri-anal procedure, which will subsequently be performed with standard instruments, will allow us to observe the ease of insertion, the expansion of the blades, and the creation of the operative field achieved. If necessary, we will modify our design based on these findings. When a successful, operating room prototype is established, the device will be suitable for clinical use and the stated benefits thereof.

Eligibility criteria: Inclusion Criteria:

* Age range 18 to 80
* In good health status
* Patients scheduled for a transanal procedure other than for anal lesions, e.g., hemorrhoids, fissures, abscesses

Exclusion Criteria:

* Patients with physical characteristics that distort the rectal sigmoid anatomy, e.g., spinal lesions.
* Patients considerable unsuitable for inclusion in the study by their colorectal surgeon.
* Patients considered too frail or ill by their physician to undergo a 5-10 minute prolongation of their procedure.
* Patients with known rectosigmoid infections.
* Patients with known rectosigmoid wall fragility.
* Patients with known rectosigmoid perforations.

Primary outcomes:
measure: Visual assessment of operative field dimensions measured in centimeters
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Henry Buchwald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06707792: Validity and Reliability of 6 Minute Stepper Test in Kidney Transplant Recipients
Official title: Investigation of Validity and Reliability of 6 Minute Stepper Test in Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Transplanted Recipients
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant recipients will be included.

Brief summary: The aim of our study was to investigate the validity and reliability of the 6 minute stepper test in kidney transplant recipients.


Eligibility criteria: Inclusion Criteria:

* Patients with kidney transplantation
* At least 6 months after the kidney transplant
* Not having regular exercise habits
* Voluntary participation in the study

Exclusion Criteria:

* Having a musculoskeletal problem that may interfere with the tests
* Having neurological impairment
* Having chronic lung disease
* Having had any cardiovascular event in the last 6 months

Primary outcomes:
measure: Exercise capacity
timeFrame: Day 1
measure: Exercise capacity
timeFrame: Day 1
measure: Peripheral muscle strength
timeFrame: Day 1
measure: Lower extremity endurance
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT01126892: A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Official title: An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Myeloid Leukemia
Keywords: Advanced Disease,
Resistance,
Intolerance
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-05-20
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: A multicenter, open label study of Nilotinib in CML patients PH + with imatininb resistant in blast crisis, accelerated phase or chronic phase. The main purpose is evaluate the safety and efficacy of Nilotinib.


Eligibility criteria: Inclusion Criteria:

Stratum 1:

1. Currently participating in Novartis study CAMN107A2109
2. Written signed and dated informed consent prior to any study procedures being performed

Stratum 2:

1. Male or female
2. \> 18 years
3. ECOG 0,1,2
4. ASL/ALT \<= 2.5 ULN or \<= 5.0 ULN
5. Alcaline Phosfatase \<= 2.5 ULN
6. Serum Bilirrubin \<= 1.5 ULN
7. Serum Creatinine \<= 1.5 ULN or creatinine clearance \>=50 ml/min / 24 hours
8. Serum Lipase \<= 1.5 ULN

Exclusion Criteria:

Stratum 1 and stratum 2:

1. Reduction of the cardiac function
2. Use of Coumadin
3. Other severe medical concurrent conditions
4. Treatment with medications that prolonged the QT interval.
5. Mayor surgery 15 days before the inclusion in the protocol
6. Pregnant women or lactation

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the CAMN107A2109 study.
timeFrame: between 6 and 12 months
Secondary outcomes:
measure: To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response
timeFrame: 24 months
measure: To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study
timeFrame: 24 months
measure: To follow loss of HR (after previous confirmed HR for AP and CHR for CP)
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Hospital San José, Bogotá, Colombia
city: Caracas
country: Venezuela
facility: Banco Municipal de Sangre
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticlas
role: STUDY_DIRECTOR
References: