louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01162889: Study To Assess The Safety And Tolerability Of Increasing Single Doses Of ATR-107 (PF-05230900) In Healthy People
Official title: Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of ATR-107 Administered Subcutaneously And Intravenously To Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
Crohn's disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-07-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a "first in human" study to determine the safety and tolerability of the drug after single doses. Nine doses of increasing strength will be injected or infused (given into a vein) to 9 different groups of people. One third of the participants will be given an injection or infusion of placebo (sugar water). All participants will be healthy people.

Detailed description: First in human single dose study. Study terminated 12 October 2011. The ATR-107 Development team reached a recommendation to terminate further development of ATR-107 (PF-05230900). This was based on a number of factors, including development of anti-drug antibodies in approximately 70% of subjects in the First-in-Human study in healthy volunteers (B2281001). This recommendation is not based on adverse events observed in study B2281001.

Eligibility criteria: Inclusion Criteria:

* Females of non-childbearing potential
* Body mass index between 17.5 to 30.5 and body weight \> 50 kg

Exclusion Criteria:

* History of significant medical illness
* Positive urine drug screen or alcohol dependance
* Smoking \> 10 cigarettes per day

Primary outcomes:
measure: Treatment-emergent AEs and SAEs, AEs leading to withdrawal, immunogenicity, injection and infusion reactions, and clinically significant changes in laboratory tests, vital signs and ECGs if reported.
timeFrame: 20 months
measure: Pharmacokinetics parameters - Cmax, Tmax, AUC(0-oo), AUClast, t 1/2, CL and Vz
timeFrame: 19 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
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 NCT03742089: Evaluation of the BHX Implant in Children with a BAHS
Official title: Evaluation of Implant Stability and Audiological Benefit of Oticon Medicals BHX Implant in Children Undergoing Surgery for a Percutaneous Bone Anchored Hearing System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss, Conductive
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2018-11-15
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric population eligible for a bone anchored hearing surgery

Brief summary: The purpose of this study is to in a proactive manner collect high quality data from pediatric patients who have undergone a bone anchored hearing surgery, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of bone anchored hearing systems in the pediatric population.


Eligibility criteria: Inclusion Criteria:

1. Patients who have decided to undergo a Bone Anchored Hearing Surgery and receive a Ponto system.
2. Signed informed consent.
3. Patients between 5 - 16 years of age.
4. Patients eligible for one stage surgery.
5. Patients who have been using Ponto sound processor on a soft band for at least 2 weeks.

Exclusion Criteria:

1. Patients who cannot attend follow up visits.
2. Patients with single side deafness (SSD).
3. In surgeon's opinion, any other disorder and condition that may deem the patient unfit to participate in the study.
4. Patients who receive other implant than the Ponto BHX.

   -

Primary outcomes:
measure: Implant stability
timeFrame: 6 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital
Study officials:
References:
Clinical trial NCT04730089: Epidural Block Impairs HPV During One-lung Ventilation: an EIT- Based Prospective Observation Study
Official title: Epidural Block Impairs Hypoxic Pulmonary Vasoconstriction During One-lung Ventilation: an Electrical Impedance Tomography- Based Prospective Observation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epidural Block
Electrical Impedance Tomography
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring thoracic surgery are given combined epidural anesthesia.

Brief summary: Define the effect of epidural block on HPV by EIT.

Detailed description: Epidural block may affect the physiological mechanism of hypoxic pulmonary vasoconstriction, which is still poorly understood. Electrical impedance tomography might be helpful in establishing the hypoxemia etiology at bedside via combining regional ventilation and perfusion information.

Eligibility criteria: Inclusion Criteria:

* Age 18 - 80 years Existing central venous and arterial access Chest circumference 70 - 150 cm

Exclusion Criteria:

* Contraindication to central venous injection of 5 % sodium chloride (NaCl)

Contraindications of PulmoVista 500:

Patients with pacemakers, defibrillators or other electrically active implants Patients with damaged skin or impaired skin contact of the electrodes due to wound dressings Patients where the attachment of the patient belt could pose a risk to the patient, e.g. patients with spinal lesions or fractures Patients with uncontrolled body movements Extremely obese patients (BMI\>50) Patients during pregnancy Patients with massive lung edema Use during electricity-based therapies, such as electrosurgery or electrocautery Use in the presence of strong magnetic fields Use in conjunction with other bioimpedance measurement devices

Primary outcomes:
measure: Assess regional distribution of pulmonary perfusion
timeFrame: within 24 hours
measure: Assess oxygenation status
timeFrame: within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ming Zhong, MD, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02683889: Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation
Official title: The Use of Acthar (ACTH) in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Have Developed Chronic Kidney Disease Stage V (CKD) or End Stage Renal Disease (ESRD) and Are Undergoing a Renal Transplant
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: FSGS
Keywords: Kidney transplant
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will evaluate the use of Acthar in patients to undergo renal transplantation and will measure the rate of FSGS recurrence.

Detailed description: This is a prospective study enrolling renal transplant recipients with the primary native kidney disease of FSGS.

Primary endpoint is rate of recurrence of FSGS as seen in renal transplant biopsies and in rate of proteinuria. Secondary endpoint is renal function after transplantation The target subject number is 20 patients and the target population is primary FSGS patients. By the current data, FSGS should recur in 23% of patients. Therefore, it would be expected that at least 4 patients will develop recurrent FSGS after renal transplantation.

Screening will be performed by the Principal Investigator during the kidney transplant evaluation clinics and during the wait list kidney transplant evaluation clinic. All patients with FSGS will have maintenance immunosuppression with belatacept (if EBV positive), prograf, cellcept and prednisone. If after one year the patient has been stable and there has not been rejection, will stop the prograf and continue solely with belatacept, cellcept and prednisone.

Dosage and Administration of Acthar The dose of acthar to be given to every enrolled patient will be 80 units twice a week for 6 months.

Eligibility criteria: Inclusion Criteria:

* FSGS
* To receive either a live donor or deceased donor kidney transplant

Exclusion Criteria:

* Not having FSGS

Primary outcomes:
measure: Rate of recurrence of FSGS as seen in renal transplant biopsies proteinuria
timeFrame: 2 years
measure: Rate of recurrence of proteinuria
timeFrame: 2 years
Secondary outcomes:
measure: renal function after transplantation
timeFrame: 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Georgetown Transplant Institute
state: District of Columbia
Study officials:
affiliation: University of Colorado, Denver
name: Sixto Giusti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00495989: Saliva and Dental Calculus in Handicapped People
Official title: The Relationship Between Saliva and Dental Calculus in a Population of Institutionalized Handicapped Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disabled Persons
Keywords: Handicapped individuals
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2007-07-04
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an evaluation of potential differences in saliva composition and dental calculus composition between orally fed and tube fed individuals in an institutional environment.


Eligibility criteria: Inclusion Criteria:

* handicapped (mentally and/or physically) persons in an institute
* older than 5 years of age
* both sexes
* full medical records available

Exclusion Criteria:

* healthy individuals
* disabled individuals not staying in an institution

Primary outcomes:
measure: Saliva composition and dental calculus composition
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Johan Aps, DDS, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06745089: Treatment Effect of Intense Pulsed Light and Thermal Pulsation Therapy on Meibomian Gland Dysfunction-associated Dry Eye Disease: a Randomized Trial
Official title: Treatment Effect of Intense Pulsed Light and Thermal Pulsation Therapy on Meibomian Gland Dysfunction-associated Dry Eye Disease: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease (DED)
Meibomian Gland Dysfunction
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: Nobel Eye Institute
name: National Science and Technology Council, Taiwan
name: National Health Research Institutes, Taiwan
First posted: 2024-12-20
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to understand novel treatment methods for meibomian gland dysfunction (MGD)-associated dry eye disease (DED) by comparing two treatment modalities- intense pulsed light (IPL) and thermal pulsation therapy (TPT), to find out the difference of their therapeutic mechanisms and treatment effects, so that eye doctors can give more precise advice to the patients when making treatment decisions.

The main questions it aims to answer are:

* What subtype of meibomian gland dysfunction (MGD) better responds to which treatment modality?
* How long do the treatment effects last?

Researchers will compare each group (IPL and TPT) to a control group treated with eyedrops.

\* Do combined treatment of IPL or TPT with eyedrops show better outcomes than only eyedrops?

Participants will:

* Receive different treatment for 2 months according to the group they were randomly allocated to.
* Visit the clinic for checkups after 1 and 3 months after completing the treatment sessions.


Eligibility criteria: Inclusion Criteria:

* individuals diagnosed with meibomian gland dysfunction (MDG)-associated dry eye disease (DED) that are suitable for intense pulsed light (IPL) and thermal pulsation therapy (TPT)

Exclusion Criteria:

* ocular surgery or trauma in the recent 3 months
* ocular infection
* eyelid abnormalities (e.g., entropion, ectropion, lagophthalmos, severe ptosis or trichiasis)
* blepharospasm
* eyelid tumor
* severe meibomian gland atrophy
* allergic to topical anesthetics
* sunbathe in recent one month
* periocular fillers

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI) questionnaire
timeFrame: From enrollment to the end of post-treatment follow-up at 5 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Institute of Biophotonics, National Yang Ming Chiao Tung University
Study officials:
References:
Clinical trial NCT04683289: Visco-Circumferential-Suture-Trabeculotomy Versus Trabeculotomy
Official title: Surgical Outcomes of Visco-Circumferential-Suture-Trabeculotomy in Primary Congenital Glaucoma: A 3-year Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Congenital Glaucoma
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 51
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: comparing outcomes of Visco-Circumferential-Suture-Trabeculotomy in primary congenital glaucoma to trabeculotomy

Detailed description: prospective randomized interventional study conducted on infants below the age of 2 years with PCG attending the outpatient clinic of Mansoura Ophthalmic Center of Mansoura University were recruited to compare the long-term surgical outcomes of this proposed technique (VCST) and rigid probe VT in patients with PCG.

Eligibility criteria: Inclusion Criteria:

* infants below the age of 2 years with PCG

Exclusion Criteria:

* patients older than 2 years on presentation
* eyes with previous surgery
* eyes with secondary glaucoma
* eyes diagnosed as anterior segment dysgenesis syndrome

Primary outcomes:
measure: IOP
timeFrame: 36 months
Secondary outcomes:
measure: complications
timeFrame: 36 months months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Ophthalmic Center
Study officials:
References:
Clinical trial NCT00213889: TWIST Human Gene and Cleft Lips and Palates
Official title: TWIST Human Gene and Cleft Lips and Palates
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cleft Lip
Keywords: Facial clefting
twist
craniofacial development genes
Human cleft lip and palate
cleft lip and palate
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study uses a sequence analysis for TWIST and other craniofacial development genes, among patients presenting with facial clefting.


Eligibility criteria: Inclusion Criteria:

Patients aged from 1 month to 18 years:

* Parents agree to enrollment or patients, themselves, agree to enrollment when able to do so
* Healthcare insurance holders
* Display facial clefting

Grown patients over 18 years of age:

* Agree to enrollment
* Display facial clefting
* Healthcare insurance holders

Exclusion Criteria:

* Patients declining enrollment
* Patients without healthcare insurance

Primary outcomes:
measure: to show, among patients displaying facial clefting, the TWIST mutations and the mutation in genes involved with TWIST in craniofacial development
timeFrame: Not relevant
Secondary outcomes:
measure: to show, among patients displaying facial clefting and mutations in such genes, possible mutations in the same genes
timeFrame: Not relevant
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Centre d'Investigations Cliniques, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
city: Strasbourg
country: France
facility: Centre de Soins , d'Enseignement et de Recherche Dentaire (CESRD), Hôpital Civil, Hôpitaux Universitaires de Strasbourg
city: Strasbourg
country: France
facility: Service de Chirurgie Infantile, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
city: Strasbourg
country: France
facility: Service de Consultation de la Face, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Laboratoire de Génétique Molécules des Eucaryotes (LGME)
name: Pascal TSCHILL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01104389: Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging
Official title: A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Renal Tumors
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2010-04-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors. To determine the feasibility of the fluorescence imaging on the da Vinci Surgical System in robotic partial nephrectomy procedures and report perioperative outcomes.


Eligibility criteria: Inclusion Criteria:

* Ages of 18 to 80 years.
* Urine pregnancy test negative for women of childbearing potential prior to surgery
* Subject is able to comply with the study procedures
* A CT or MRI preoperative assessment of renal cortical tumor
* The renal tumor must be stage T1a-b - T2
* Written informed consent.

Exclusion Criteria:

* Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as total bilirubin \>1.5 X normal and/or SGOT \>2X normal
* Subject has uremia, serum creatinine \>2.0 mg/dl.
* Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
* Subject in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
* Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
* Subject is pregnant or lactating
* Subjects actively participating in another drug, biologic and/or device protocol
* The presence of medical conditions contraindicating general anesthesia or standard surgical approaches.

Primary outcomes:
measure: The rate of good or excellent fluorescence images achieved intraoperatively. It will be measured by the correlation of the ultrasound imaging with the fluorescence imaging.
timeFrame: Intraoperatively
Secondary outcomes:
measure: Include but not limited to the rate of positive surgical margins, incidence of complications, estimated blood loss and length of stay.
timeFrame: up to 3 weeks postoperatively
Other outcomes:
Locations:
city: St Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References:
Clinical trial NCT06232889: Deuterium Metabolic MRI and [18F]FDG PET for Assessment of Treatment Response Following Radioembolization
Official title: Deuterium Metabolic MRI and [18F]-Flourodesoxyglucose Positron Emission Tomography for Assessment of Treatment Response Following Radioembolization; Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fluorodeoxyglucose F18
Phosphoric Monoester Hydrolases
Phosphoric Diester Hydrolases
Keywords: FDG-PET
31P spectroscopy
MRI
Deuterium Metabolic Imaging
SIRT
TARE
Radioembolization
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Radioembolization, also known as Selective Internal Radiation Therapy (SIRT), is a liver-directed therapy for patients suffering from hepatic metastases. As SIRT is a liver-directed treatment, only patients with liver-only or liver-dominant disease are eligible for treatment. FDG-PET/CT is known to outperform conventional anatomical imaging modalities (CT or MRI) for treatment response assessment, also being of prognostic value. Subsequently following SIRT, patients are restaged with FDG-PET/CT. However, optimal timing of restaging following treatment is unknown (most commonly after 1 or 3 months, according to local institutional guidelines). More importantly, intrinsic resolution of FDG-PET/CT limits its utility in patients with small metastases, as image quality is worsened by high background noise, due to physiologic FDG uptake / metabolism in normal liver parenchyma. Additionally, FDG as radiopharmaceutical increases additional radiation burden to patients. This study will investigate the potential of metabolic MRI (7T MRI), non-invasively imaging metabolites using X-nuclei (e.g. 31P MRSI) and more importantly, the application of Deuterium Metabolic Imaging (DMI) with non-radioactive deuterated glucose, as a potential alternative over FDG-PET/CT.


Eligibility criteria: Inclusion Criteria:

* Adults (≥18 years)
* Referred for SIRT and deemed eligible by the multidisciplinary tumor board
* Size of at least one liver metastasis ≥ 1 cm on contrast enhanced CT / MRI (measurable according to RECIST 1.1) and 18FDG-avid metastatic liver disease (uptake \> healthy liver uptake; measurable according to PERCIST)
* Written informed consent

Exclusion Criteria:

* Patients having FDG-negative disease (according to PERCIST)
* Patients with diabetes mellitus
* Patients having a general contra-indication for SIRT
* Patients with contra-indications for 7T MR scanning
* Patient unable to complete study scan (laying still for a long time)
* Patient unable or incapable to follow study proceedings

Primary outcomes:
measure: To confirm feasibility of DMI for intrahepatic tumor detection.
timeFrame: 1 and 3 months after radioembolization, anatomical and molecular imaging is repeated.
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
References: