louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00666510: Bronchospasm Associated With High Nitric Oxide
Official title: Higher Exhaled Nitric Oxide (NO) is Associated With Intraoperative Bronchospasm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Airway Hyperresponsiveness
Keywords: nitric oxide
bronchospasm
anesthesia
induced sputum
asthma
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-04-25
Enrollment: 31
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital, late post-anesthesia cared patients

Brief summary: Intraoperative bronchospasm challenges anesthesia's safety. This study aims to investigate high concentration of exhaled nitric oxide as a marker of intraoperative bronchospasm.

Detailed description: Previous studies in asthmatic patients suggested that exhaled nitric oxide may represent a noninvasive measure for airway inflammation. Anesthesia information forms from 1999 throughout 2004 were revised (n=146.358). Bronchospasm occurrence appeared registered on 863 forms. From those, nine were identified as non-asthmatics patients (Bronchospasm group). Also, 12 asthmatics constituted one additional group (Asthma group) and 10 subjects with no previous airway disease or symptoms (Control group). All subjects were submitted to Exhaled nitric oxide measurements (parts/billion), spirometry and induced sputum.

Eligibility criteria: Inclusion Criteria:

* patients with no systemic disease and registered bronchospasm during anesthesia induction

Exclusion Criteria:

* hypertension, COPD, diabetes, pregnancy

Primary outcomes:
measure: Exhaled nitric oxide in parts per billion
timeFrame: one to six months after surgery
Secondary outcomes:
measure: Eosinophils concentration within sputum sample, pulmonary function tests
timeFrame: one to six months after surgery
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da FMUSP
Study officials:
affiliation: University of Sao Paulo Medical School - FMUSP
name: Joaquim E Vieira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02595710: Bartonella in Liver Transplant Patients
Official title: Undetected Bartonella Spp. Infection Puts Liver Transplant Patients at Great Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cryptogenic Cirrhosis
Cryptogenic Chronic Hepatitis
Keywords: Cryptogenic Chronic Hepatitis
Bartonellosis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes subjects ages 18 and above. Patients of the University of Minnesota Transplant Center who meet the inclusion/exclusion criteria will be given the opportunity to participate in this study. Dr. Lake has several liver transplant clinics and appropriate patients will be offered the opportunity to participate in this study.

Brief summary: Approximately 20 volunteers who have received a liver transplant and have been diagnosed with cryptogenic cirrhosis will be included in this study. Blood, skin and urine samples will be analyzed for Bartonella spp..

Detailed description: Approximately 20 volunteers who have received a liver transplant and have been diagnosed with cryptogenic cirrhosis will be included in this study. Blood samples will be analyzed for Bartonella using the state-of-the art Bartonella Alpha Proteobacterium Growth Medium (BAPGM) multi-platform testing, including liquid culture, enriched agar plating and molecular techniques. Blood smears will be analyzed for intra-erythrocytic Bartonella spp. Four-millimeter skin biopsies from non-lesional skin will be acquired from the same patients, processed using our published techniques, and imaged using confocal microscopy and compared to BAPGM test results. additionally, urine samples will be collected and analyzed for microRNAs.

Eligibility criteria: Inclusion Criteria:

* o Male and female subjects, ages 18 years and older

  * Liver transplant recipient
  * Diagnosis of cryptogenic cirrhosis
  * Signed consent form

Exclusion Criteria:

* none

Primary outcomes:
measure: Liver transplant subject that show evidence of Bartonella DNA and Bartonella antibodies using the Alpha Proteobacterium Growth Medium (BAPGM)
timeFrame: 90 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Marna E Ericson, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04229810: Individualized Perioperative Open Lung Ventilatory Approach in Emergency Abdominal Laparotomy. A Prospective Multicenter Randomized Controlled Trial.
Official title: Individualized Perioperative Open Lung Ventilatory Approach in Emergency Abdominal Laparotomy. A Prospective Multicenter Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilator Lung
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 732
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prospective multicenter randomized controlled trial. Individualized perioperative open lung ventilatory approach in emergency abdominal laparotomy.


Eligibility criteria: Inclusion Criteria:

* Adult men and women ≥18 years of age who underwent emergency laparotomy with the presence of post-induction positive air-test (SpO2 \<97% after a maximum of 15 minutes at FIO2 of 0.21). A SpO2 \<97% at any FIO2 would also be considered a positive air-test.

Exclusion Criteria:

* 1) Pregnancy or breast feeding, 2) Moderate or severe ARDS defined, 3) refractory shock, 4) diagnosis or suspected intracranial hypertension (\>15mmHg), 5) mechanical ventilation in the last 15 days (including CPAP), 6) presence of pneumothorax or giant bullae in a chest radiograph or computed tomography (CT), 7) patients participating in another intervention study with the same or similar primary outcome variable.

Primary outcomes:
measure: Severe postoperative pulmonary complications
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00683410: Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent)
Official title: A Prospective, Observational Study to Monitor Safety in Patients Who Were Administered With Pneumococcal Conjugate Vaccine, 7-valent (Prevenar) 0.5 mL by Intramuscular Injection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccines, Pneumococcal Conjugate Vaccine
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-23
Enrollment: 3366
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care

Brief summary: To collect post-marketing information on the safety of Prevenar in Filipino patients


Eligibility criteria: Inclusion Criteria:

* All patients from the study center who received or will receive at least one dose of Prevenar according to the approved product indication.

Exclusion Criteria:

* Previously discontinued Prevenar therapy due to safety concerns.

Primary outcomes:
measure: Number of Participants With Spontaneous Adverse Events
timeFrame: 30 days post injection up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Muntinlupa City
country: Philippines
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06664710: Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
Official title: Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Sensorineural
Cochlear Implantation
Keywords: cochlear implantation
sensorineural hearing loss
robotics
Lead sponsor: iotaMotion, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-29
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery

Detailed description: The purpose of this study is to evaluate the feasibility and proof of concept of the integration of the AIM System and iotaSOFT Insertion System during cochlear implantation. Study results will help inform the need for future clinical investigations and data collection in the area of ECochG and robotic-assisted cochlear implantation.

Eligibility criteria: Inclusion Criteria:

1. Cochlear implant candidate in one or two ears per current FDA indications
2. Sufficient residual hearing to support use of electrocochleography, as determined by the investigator
3. Cochlear implantation using the Advanced Bionics SlimJ electrode array
4. 18 years of age or older at the time of enrollment
5. Willingness to participate in and comply with all requirements of the protocol

Exclusion Criteria:

Contraindications for a CI. 2. Prior cochlear implantation in the ear to be implanted. 3. Cochlear ossification or malformation (including but not limited to dysplasia or common cavity), craniofacial abnormality or any other structural cochlear abnormality that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.

4. History of temporal bone fracture that involves the cochlea/internal auditory canal.

5. Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway).

6. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.

7. Planned or current participation in a clinical study of an investigational device or drug that may impact data collection or outcomes related to this investigation.

8. Additional medical concerns that would prevent participation in evaluations as determined by the investigator.

9. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.

10. Vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56

Primary outcomes:
measure: Device Feasibility
timeFrame: Procedure Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
References:
Clinical trial NCT02951910: A Study of the Effect of Zinc-Hyaluronate on Ocular Surface Sensations in Patients With Dry Eye
Official title: A Study of the Effect of Zinc-Hyaluronate on Ocular Surface Sensations in Patients With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hyaluronic acid, a natural polymer, helps to maintain ocular surface hydration and can already be found in several artificial tears recommended to alleviate symptoms of dry eye. A recent hyaluronate modification involves zinc-hyaluronate complex formation by adding zinc-chloride to an aqueous sodium-hyaluronate resulting in a very stable molecular structure, which functions as both a mechanical barrier and a biocompatible film on the ocular surface. Apart from its beneficial elastoviscous characteristics, previous results indicate that hyaluronate can also reduce the excitability of the peripheral nociceptor endings underlying pain. Although hyaluronate is widely used in artificial tears to improve tear film stability, its effect on ocular surface sensitivity was not evaluated in patients with dry eye. The aim of this study is to investigate the characteristics of ocular surface sensations and corneal sensitivity in dry eye patients before and after long-term tear supplementation with zinc-hyaluronate.


Eligibility criteria: Inclusion Criteria:

* Patients who had been diagnosed as having dry eye symptoms for at least 3 months, with an OSDI score of ≥13 evaluated by the questionnaire of Ocular Surface Disease Index (OSDI)

Exclusion Criteria:

* Subjects with ophthalmic conditions other than dry eye or systemic disease including blepharitis, meibomitis, lid abnormalities as well as contact lens wearers

Primary outcomes:
measure: Change in OSDI (Ocular Surface Disease Index) score
timeFrame: 1 month
Secondary outcomes:
measure: Change in corneal sensitivity to selective stimulation
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
citation: Perenyi K, Dienes L, Kornafeld A, Kovacs B, Kiss HJ, Szepessy Z, Nagy ZZ, Barsi A, Acosta MC, Gallar J, Kovacs I. The Effect of Tear Supplementation with 0.15% Preservative-Free Zinc-Hyaluronate on Ocular Surface Sensations in Patients with Dry Eye. J Ocul Pharmacol Ther. 2017 Jul/Aug;33(6):487-492. doi: 10.1089/jop.2016.0194. Epub 2017 Apr 4.
Clinical trial NCT00926510: The Use of a Language Toolkit for Toddlers
Official title: Two to Talk: The Use of a Language Toolkit for Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Language Acquisition
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate whether young children with isolated expressive language delay benefit from early intervention with a simple language toolkit and brief instructions provided to their caregivers.

We hypothesize that children whose families are provided the language toolkit will develop more words over the subsequent 3 months.


Eligibility criteria: Inclusion Criteria:

* Age 14.5 to 18.5 months
* Below average expressive language
* Otherwise normal development

Exclusion Criteria:

* Other developmental delay
* Non-English primary language

Primary outcomes:
measure: Language/Words acquisition
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: North Carolina Children's Hospital
state: North Carolina
Study officials:
affiliation: UNC Hospitals
name: Michael J Steiner, MD
role: STUDY_DIRECTOR
affiliation: UNC Hospitals
name: Jennifer Hartz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC Hospitals
name: Mary Ann Cross, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC Hospitals
name: Karen L Wysocki, MS, M Ed
role: STUDY_DIRECTOR
References:
Clinical trial NCT01232010: Clinical Study to Investigate the Safety and Pharmacokinetics of SK3530 Tablet in Renal Impaired Male Patients
Official title: Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Insufficiency
Kidney Diseases
Urologic Diseases
Keywords: SK-3530
renal impairment
healthy volunteers
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: SK Chemicals Co., Ltd.
First posted: 2010-11-02
Enrollment: 12
Sex: MALE
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to investigate the effect of renal impairment on the safety and pharmacokinetics of SK3530 in subjects with renal impairment compared to healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Adult males aged 19 to 64 years at screening.
* Subjects with body weight ≥ 50 kg and within ±30% of the ideal body weight : Ideal body weight = (height \[cm\] - 100)x0.9.
* Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria:

* Subjects with the test results of QTc \> 430 ms or non-sinus cardiac rhythm by ECG analysis.
* Subjects with hypotension or hypertension.
* Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Primary outcomes:
measure: Pharmacokinetics (AUC and Cmax)
timeFrame: 2days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun-Seop Bae, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03427710: A First In Human Study to Assess CiVi007 in Subjects With an Elevated LDL-Cholesterol Level
Official title: A Placebo-controlled, Single Blind, Randomised, Phase I, First In Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered CiVi007 in Subjects With an Elevated LDL C Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Lead sponsor: Civi Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adaptive design allowing modifications in single and multidose arms
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess pharmacokinetics, dynamics, safety and tolerability of CiVi007 following single and multiple subcutaneous doses in subjects, including those on statin therapy


Eligibility criteria: Key Inclusion Criteria:

* Males or females, of any race, with fasting LDL C \>2.6 mmol/L (100 mg/dL) and fasting serum triglycerides \<4.52 mmol/L (400 mg/dL)
* haematology and clinical chemistry without clinically significant abnormal values
* Normal renal and hepatic function
* Women must not be pregnant, lactating or of child bearing potential
* Men must be willing to use appropriate contraception during the study
* Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Key Exclusion Criteria:

* Any uncontrolled or serious disease, or any medical or surgical condition
* History or presence of coronary heart disease, peripheral artery disease, or cerebrovascular disease
* Uncontrolled hypertension
* Insulin dependent diabetes mellitus
* Secondary dyslipidemia
* History of renal or hepatic diseases, acquired immune deficiency syndrome, positive human immunodeficiency virus test and/or history of viral hepatitis B or C
* History of cancer within 5 years
* History of high alcohol consumption or positive alcohol breath test or urinary test for drugs of abuse
* Participation in another clinical study within 3 months prior to screening or participation in another study
* Use of treatment (e.g. antibody) towards PCSK9
* History of multiple drug allergies or intolerance to subcutaneous injection.

Primary outcomes:
measure: LDL Cholesterol
timeFrame: Maximum post dose within 8 weeks
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax) of CiVi007
timeFrame: 8 weeks
measure: PCSK9 level
timeFrame: Maximum post dose within 8 weeks
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Clinic
state: West Yorkshire
Study officials:
affiliation: Covance
name: Jim Bush, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02210910: InSpace™ System Over Rotator Cuff Repair in Comparison to Repair Alone.
Official title: A Randomized, Two-arm, Prospective Study to Assess the Efficacy and Safety of InSpace™ Device Implanted Over a Rotator Cuff Repair in Comparison With Rotator Cuff Repair Only
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: Massive Rotator Cuff Tear, Sub-acromial spacer, Best repair of rotator cuff
Lead sponsor: OrthoSpace Ltd.
Sponsor class: INDUSTRY
First posted: 2014-08-07
Enrollment: 39
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ in the study population in comparison to surgical RCT repair.

Detailed description: The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living (ADL) and improvement of range of motion (ROM).

Eligibility criteria: Main Inclusion Criteria:

* Age 40 or older.
* Positive diagnostic MRI of the affected shoulder indicating full thickness large to massive RCT of at least 3cm in diameter (according to Cofield classification2) involving one or more tendons. (MRI can be done up to 6 months prior to randomization.)
* Persistent pain and functional disability of the affected shoulder for at least 3 months.

Main Exclusion Criteria :

* Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
* Evidence of significant osteoarthritis or cartilage damage in the shoulder
* Evidence of gleno-humeral instability
* Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
* Evidence of major joint trauma, infection, or necrosis in the shoulder
* Partial-thickness tears of the rotator cuff

Primary outcomes:
measure: The change in the Shoulder Score
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
Study officials:
References:
Clinical trial NCT00199810: Hemodynamic Measurements in Women With Serious Preeclampsia
Official title: Hemodynamic Measurements in Women With Serious Preeclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: Cardiac output
Preeclamptic women
systemic vascular resistance
blood pressure
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with moderate-to-severe pre-eclampsia

Brief summary: This trial is examining hemodynamic measurements in women with serious preeclampsia.


Eligibility criteria: Inclusion Criteria:

* Women with serious preeclampsia

Primary outcomes:
measure: Hemodynamic variations in preeclamptic women
timeFrame: days
Secondary outcomes:
measure: Urine output
timeFrame: days
measure: thrombocyte count
timeFrame: days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Eldrid Langesæter Langesæter
role: PRINCIPAL_INVESTIGATOR
References: