louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01020136: A Bioequivalence Study Of AG-013736 Tablets Under Fed Conditions In Healthy Volunteers
Official title: A Phase 1 Bioequivalence Study To Compare The Plasma Pharmacokinetics Of AG-013736 Polymorph Form IV Versus Market-Image Polymorph Form XLI Tablets In Healthy Volunteers Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Bioequivalence Pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose is to show that 5 mg Form IV tablet of AG-013736 produces similar drug concentrations in plasma compared to 5 mg Form XLI tablet of AG-013736 after oral dosing under fed conditions.

Detailed description: To establish bioequivalence between Form IV and Form XLI of AG-013736 tablets

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 47 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ECG) and clinical laboratory tests)
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)
* An informed consent document signed and dated by the subject or a legally acceptable representative

Exclusion Criteria:

* Evidence of significant disease of the blood, kidney, endocrine system, lungs, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic (including drug allergies, but excluding season allergies)
* Use of tobacco- or nicotine- containing products (or a positive urine cotinine test).
* Pregnant or nursing females and females of childbearing potential including those with tubal ligation

Primary outcomes:
measure: To establish the bioequivalence of test 5 mg market-image tablets of AG-013736 polymorph Form XLI to reference 5 mg tablets of AG- 013736 polymorph Form IV under fed conditions.
timeFrame: 3 days per period
Secondary outcomes:
measure: To assess the safety and tolerability of single dose AG-013736 when administered as polymorph Forms XLI and IV in healthy volunteer
timeFrame: 3 days per period
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02329236: Prevalence of Attention Deficit Disorder Among Patients With Constitutional Growth Delay
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention-deficit/Hyperactivity Disorder
Constitutional Growth Delay
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children with short stature due to constitutional growth delay or familial short stature followed at the endocrine unit.

Brief summary: The aim of the our study is to investigate whether there is an increased incidence of ADHD ( based on self reports and questionnaires) among children with short stature due to constitutional growth delay (CGD) in comparison with children with Familial short stature.

Detailed description: Filling out the study questionnaire by ADHD diagnosed and suspected children (have a positive DBDRS (Disruptive Behavior Disorders Rating Scale Questionnaire) result) who were referred to the pediatric endocrine clinic of our hospital for short statue evaluation. The study questionnaire will be filled by child's guardian.

The study and the DBDRS questionnaires will be filled only after obtaining an informed consent.

The required data including growth statistics, age at puberty, bone age and other relevant data will be collected from the child's medical records.

The data on patients will be processed anonymously.

Eligibility criteria: Inclusion Criteria:

* undergo evaluation and follow-up due to short stature caused by either CGD or Familial short stature

Exclusion Criteria:

* Children with short stature due to other reasons such as hormonal disorders (thyroid disorders, growth hormone deficiency), genetic syndromes

Primary outcomes:
measure: incidence of ADHD among children with short stature due to constitutional growth delay (CGD) in comparison with children with Familial short stature
timeFrame: single point in time during the visit at the endocrine clinic
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04770636: Glucose Disturbances in Premature Infants and Quality of Life
Official title: Glucose Disturbances in the First Day of Life in Preterm Infants and Health-related Quality of Life: is There a Correlation?
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Neonatal Hypoglycemia
Neonatal Hyperglycaemia
Keywords: Preterm birth, Hypoglycemia, Hyperglycemia, Quality of life
Lead sponsor: Clinical Hospital Center Rijeka
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are all premature infants (born before 37th gestational week) treated in two intensive care units: Neonatal intensive unit cares for inborn premature infants and Pediatric intensive care unit takes care for premature infant born in other hospitals in three counties.

Brief summary: The aim of this study is to investigate the correlation between preterm birth, glucose level in the first two hours of life and health related quality of life in the age of 8 months and 7 years

Detailed description: All premature infants treated from August 2013-August 2014 in two Neonatal intensive care units (NICUs) are included in this study. Glucose levels was analyzed two hours after birth. In the age of 8 months parents completed the questionnaire Pediatric Quality of Life - Infant scale. The questionnaire Quality of life for children 5-7 years and for their parents will be offered to them in the next 4 months.

We will investigate if there is a correlation between glucose levels and quality of life in premature infants, and if quality of life changes over years.

Eligibility criteria: Inclusion Criteria: All premature infants treated in two neonatal intensive units in Clinical Hospital centre Rijeka in the year 2013.- 2014. To reach to final outcome, all questionnaires must be completed.

-

Exclusion Criteria: All deceased premature children born in the study period.

-

Primary outcomes:
measure: Comparison of glucose levels in prematures after birth and Quality of life in the age of 7 years
timeFrame: 7 years
Secondary outcomes:
measure: Comparison of Quality of life in premature infants in the age of 8 months and 7 years
timeFrame: 6,5 years
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: Clinical Hospital Centre
state: Primorsko-goranska County
Study officials:
References:
Clinical trial NCT03816436: The Impact of Clavicular Length Restoration in the Treatment of Non-unions of Clavicular Midshaft and Lateral Fractures
Official title: The Impact of Clavicular Length Restoration in the Treatment of Non-unions of Clavicular Midshaft and Lateral Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clavicular Length
Keywords: clavicle non-unions
plate treatment of clavicular fractures
cortical bone grafting of clavicular fractures
clavicular midshaft non- union
clavicular lateral non- union
clavicular shortening
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients surgically treated at the Schulthess Clinic (KWS) and at the University Hospital Basel (USB) for internal fixation with a plate and using iliac bone graft of clavicular non- unions.

Brief summary: Evaluating the impact of plate treatment and cortical bone grafting of clavicular midshaft and lateral non- unions on restoration of clavicular length and bony healing and its association with functional outcome.


Eligibility criteria: Inclusion Criteria:

* clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting
* minimal follow- up of two years after surgery
* written informed consent

Exclusion Criteria:

* legal incompetence
* non- union of pathologic fractures
* current pregnancy
* German language barrier to complete questionnaires

Primary outcomes:
measure: Clavicula shortening (cm)
timeFrame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Secondary outcomes:
measure: Constant Murley score (CS)
timeFrame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
measure: Subjective shoulder pain (NRS)
timeFrame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
measure: Subjective shoulder value (SSV)
timeFrame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
measure: Simple shoulder test (SST)
timeFrame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
measure: Quality of Life (QoL)
timeFrame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics
city: Zürich
country: Switzerland
facility: Schulthess Klinik Zürich
Study officials:
affiliation: Orthopädische Universitätsklinik Basel
name: Andreas Mueller, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02348736: Comparison of SensaScope Intuboscope and McGrath Series 5 for Endotracheal Intubation
Official title: Comparative Study Between SensaScope Intuboscope and McGrath Series 5 Videolaryngoscope to Tracheal Intubation: a Prospective Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Morbidity
Keywords: airway
videolaryngoscope
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled prospective study of laryngoscopy and intubation time comparing SensaScope and the McGrath® Series 5 video laryngoscope.

Detailed description: The use of videolaryngoscopy is increasing as a technique for rescue intubation as well as for elective intubation. Current airway management guidelines recommend video-assisted laryngoscopy as a choice for basic airway management. This is a proposed comparison study of a video laryngoscope, use in the daily anesthesia practice, and its likely increased success compared to semi-rigid stylet. An national, mono center, prospective randomized comparative trial (RCT) is proposed testing the superiority of oral tracheal intubation with the McGrath® Series 5 versus SensaScope in adult patients under general anaesthesia.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 Years No concurrent participation in another study
* capacity to consent
* Present written informed consent of the research participant
* Elective surgery under general anesthesia

Exclusion Criteria:

* Age \<18 years
* Existing pregnancy
* Lack of consent
* inability to consent
* emergency patients
* Emergency situations in the context of a Difficult Airway Management
* ASA classification\> 3
* situations where the possibility of accumulated gastric contents
* Participation in another study

Primary outcomes:
measure: comparison of different time for tracheal intubation
timeFrame: <2min
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
state: Rhineland-Palatinate
Study officials:
affiliation: University JG, Mainz
name: Marc Kriege, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Negishi Y, Shimada N, Urayama M, Niwa Y, Takeuchi M. [McGRATH MAC Videolaryngoscope: clinical assessment of its performance in 50 surgical patients]. Masui. 2014 Sep;63(9):1025-8. Japanese.
citation: Biro P. The SensaScope- A new hybrid video intubation stylet. Saudi J Anaesth. 2011 Oct;5(4):411-3. doi: 10.4103/1658-354X.87271.
citation: Biro P, Battig U, Henderson J, Seifert B. First clinical experience of tracheal intubation with the SensaScope, a novel steerable semirigid video stylet. Br J Anaesth. 2006 Aug;97(2):255-61. doi: 10.1093/bja/ael135. Epub 2006 Jun 1.
Clinical trial NCT05269836: Use of Surgify Safety Burr in Hard Tissue Cutting, Head and Spine Area
Official title: Surgify2021. Use of Surgify Safety Burr in Hard Tissue Cutting, Head and Spine Area.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spine Surgery
Surgery
Lead sponsor: Surgify Medical Oy
Sponsor class: INDUSTRY
First posted: 2022-03-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Any 18 to 70 -year old patient scheduled to back/head operation can be recruited according to other inclusion and exclusion criteria.

Brief summary: Purpose of the study: To evaluate whether the SSB is safe, useful, beneficial and effective in drilling, cutting and removal of bone tissue in neurosurgical and spine procedures.

Detailed description: Sponsored observational clinical pilot study with no control group. Aim is to get a maximum of 20 study subjects, who have disease of the spine or head requiring surgery with bone removal and who are willing to participate into this study.

Eligibility criteria: Inclusion Criteria:

* Disease of the spine or head requiring surgery with bone removal
* Ability to understand the purpose and risks of the study and to give written informed consent
* Age 18-70 years

Exclusion Criteria:

* Previous surgery on the same area
* Abnormalities of bone tissue
* Vulnerable patient (such as prisoner, retarded person, person in nursing home, patient in emergency situation)
* Allergy or hypersensitivity to medical-grade stainless steel or any of alloying components
* Problems with blood clotting

Primary outcomes:
measure: To evaluate usability of SSB
timeFrame: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.
measure: To evaluate safety of SSB
timeFrame: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.
Secondary outcomes:
measure: To evaluate effectiveness of SSB
timeFrame: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.
measure: To evaluate beneficiality of SSB
timeFrame: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUS,Töölö hospital
Study officials:
affiliation: HUS
name: Nuutti Vartiainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00332436: Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2006-06-01
Enrollment: 586
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed Combination in patients with glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes
* Patient requires IOP-lowering drug in both eyes

Exclusion Criteria:

* Uncontrolled medical condition
* Contraindication to beta-adrenoceptor antagonist or brimonidine therapy

Primary outcomes:
measure: IOP
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
state: Kentucky
Study officials:
References:
Clinical trial NCT06634836: Patient Interview Study to Explore the Impact of Gene Therapy in Hemophilia A & B
Official title: In-trial Qualitative Interviews to Explore the Impact of Gene Therapy in Hemophilia A & B
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hemophilia A
Hemophilia B
Keywords: Hemophilia A
Hemophilia B
Genetic Therapy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-10-10
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are participating in the Pfizer's gene therapy clinical trials for Hemophilia A and B or are in the long-term follow up for these clinical programs

Brief summary: The purpose of this study is to learn about experiences of patients with hemophilia A and B after taking gene therapy. The experiences of patients will be studied through online interviews.

This study is seeking participants who are:

* part of the Pfizer's gene therapy clinical studies or
* in the long-term follow up for these clinical programs. Participants will have one study visit at the clinic and one online interview. The planned duration for each participant will be 1 to 2 months. This covers the time from entering the study to end of the online interview.


Eligibility criteria: Inclusion Criteria:

* Participation in the Pfizer's gene therapy clinical trials for Hemophilia A or B .
* Participants will be one year or more post-gene therapy
* Participants will be willing to provide written consent and will be willing to comply with the study requirements

Exclusion Criteria:

-No exclusion criteria

Primary outcomes:
measure: Frequency of self-reported symptoms pre and post hemophilia gene therapy
timeFrame: From date of dosing in the gene therapy clinical trial until the interview date, no less than 52 weeks.
measure: Frequency of self-reported severity pre and post hemophilia gene therapy
timeFrame: From date of dosing in the gene therapy clinical trial until the interview date, no less than 52 weeks.
measure: Frequency of self-reported impacts pre and post hemophilia gene therapy
timeFrame: From date of dosing in the gene therapy clinical trial until the interview date, no less than 52 weeks.
measure: Change in the proportion of patients answering 5-point Likert scale questions about the burden of hemophilia on the participant's life pre-post gene therapy
timeFrame: From date of dosing in the gene therapy clinical trial until the interview date, no less than 52 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01568736: B7 Coreceptor Molecules in Hyper IgD Syndrome Form of Mevalonate Kinase Deficiency
Official title: B7 Coreceptor Molecules as Clinically-Relevant Surrogate Biomarkers in the Hyper IgD Syndrome (HIDS) Form of Mevalonate Kinase Deficiency (MKD)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hyper IgD Syndrome
Mevalonate Kinase Deficiency
Keywords: Hyper IgD Syndrome (HIDS)
Mevalonate Kinase Deficiency (MKD)
Lead sponsor: Michigan Technological University
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Hyper IgD Syndrome (HIDS)

Brief summary: The hyper IgD syndrome (HIDS) is an inflammatory disease caused by mevalonate kinase deficiency. There is no cure, and available treatments of HIDS febrile episodes have shown limited clinical efficacy. The development of effective interventions for HIDS is limited by our poor understanding of the disease. The goal of the study is to better characterize the inflammatory response during HIDS episodes and to determine the relationship between this response and blood and urine markers of mevalonate kinase deficiency. This knowledge will help us learn more about the cause of the disease and should lead to the identification of new disease biomarkers that can be used to evaluate clinical efficacy in future therapeutic trials.

The primary hypothesis is that the costimulatory B7 glycoprotein abnormalities identified in the murine MKD model will be recapitulated in sera obtained from human HIDS patients, either before, during or after febrile episodes. The secondary hypothesis is that B7 glycoprotein molecule levels will correlate with clinical symptomatic severity score, other known biomarkers of HIDS, markers of inflammation and or markers of isoprenoid metabolism.


Eligibility criteria: Inclusion Criteria:

* any race or ethnicity
* diagnosed with HIDS

Exclusion Criteria:

* parents' inability to donate blood
* currently having cancer, renal failure, diabetes, liver disease, thyroid diseases, major infectious diseases or immunodeficiency
* pregnancy
* inability to provide consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houghton
country: United States
facility: Michigan Techinical University
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Nijmegen
country: Netherlands
facility: Radbound University of Nijmegen Medical Centre
Study officials:
References:
Clinical trial NCT03962036: Effect of One-lung Ventilation on BIS Values
Official title: Effect of One-lung Ventilation on BIS Values
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Surgery
Thoracic
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical patients requiring one lung ventilation at Nationwide Children's Hospital.

Brief summary: In this observational study, all enrolled patients having a thoracic surgical procedure requiring lung isolation will have a bispectral index (BIS) monitor placed at time of induction. BIS monitors are used to assist in determining depth of anesthesia. This study will evaluate changes in BIS before, during and after lung isolation.


Eligibility criteria: Inclusion Criteria:

* Patients coming for thoracic surgery with anticipated need for lung isolation

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in BIS
timeFrame: From baseline to one lung ventilation (average time frame of 30 mins. - 1 hr.)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References: