louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01786460: Brain Injury Biomarkers in the General Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries, Traumatic
Lead sponsor: Banyan Biomarkers, Inc
Sponsor class: INDUSTRY
First posted: 2013-02-08
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers who meet eligibility criteria

Brief summary: The purpose of this study is to use an investigational assay to assess levels of putative biomarkers of traumatic brain injury (TBI) in a general population. The data will be used in a correlative analysis with data collected under a separate study of severe TBI.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age and no more than 80 years of age
* Willing to undergo consent
* PI believes volunteer is appropriate candidate for study

Exclusion Criteria:

* Participating in another clinical study that may affect the results of either study
* Non-English speaking
* Venipuncture not feasible
* Blood donation within 1 week of screening
* PI determines volunteer is not medically suitable for study participation

Primary outcomes:
measure: Assessment of the putative biomarkers for TBI markers in general population using an investigational assay
timeFrame: up to 21 days
Secondary outcomes:
measure: Correlation of the putative biomarkers for TBI levels in general population to levels in patients with severe TBI
timeFrame: 0, 14, 7, and 21 days
Other outcomes:
Locations:
city: Vista
country: United States
facility: Office of Nagi S. Ibrahim
state: California
city: Gainesville
country: United States
facility: Shands at University Florida Gainesville
state: Florida
city: Decatur
country: United States
facility: Dekalb Medical Center
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Medical Center
state: Georgia
city: Fall River
country: United States
facility: New England Center for Clinical Research
state: Massachusetts
Study officials:
affiliation: Banyan Biomarkers
name: Jackson Streeter, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00000260: Effects of Behavioral Contingencies on Effects of Nitrous Oxide - 12
Official title: Effects of Behavioral Contingencies on Effects of Nitrous Oxide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: nitrous oxide
subjective effects
reinforcer
inhalant
healthy volunteer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine the effects of different behavioral contingencies in modulating the reinforcing effects of nitrous oxide in healthy volunteers.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Mood
measure: Choice of nitrous oxide vs placebo
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Anesthesia & Critical Care
state: Illinois
Study officials:
affiliation: University of Chicago
name: James Zacny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04764760: Biomechanically Compatible,Minimally Invasive Technique for Recurrence Free Groin Hernia Repair
Official title: Former Chairman Department of Surgery St.Joseph Mercy Oakland Pontiac Former Clinical Associate Professor Surgery Wayne State University,Detroit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: tensile strength augmentation.
Lead sponsor: St. Joseph Mercy Oakland Hospital
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 486
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All patients with confirmed inguinal hernias of all types
Primary purpose: TREATMENT

Brief summary: "A bio-mechanically compatible, minimally invasive technique for recurrence-free groin hernia repair by implantation of Tensiflex mesh prosthesis for the enhancement of the tissue tensile strength of the fascia transversalis."

Detailed description: Hernia recurrences post-repair remain a confounding problem. The prospective study described herein tested Cooper's paradigm, which holds that abdominal pressure exceeding abdominal wall resistance causes hernia, by incorporating the Tensiflex mesh prosthesis which is a modified version of mesh prosthesis of Stoppa technique in the surgical treatment of patients with hernia. The study was 2-phased: the first phase involved the pre-peritoneal implantation of a bi-layered mesh for anatomical replacement of the damaged fascia. The second phase involved the implantation of the bi-layered Tensiflex mesh prosthesis for definitive and seamless augmentation of tensile strength in the myopectineal orifice of Fruchaud.

Eighty-three percent of our patients consumed analgesics for 3 days (3% reported no pain on day 3); however, by day 5, 86% reported pain intensity scores lower than 5. The median number of lost workdays was 7. Most importantly, the primary endpoint of 100% recurrence-free outcomes was met, as were the secondary endpoints (minimal pain, morbidity, and loss of workdays).

Eligibility criteria: Inclusion Criteria:

* all patients with confirmed groin hernia of both sexes.

Exclusion Criteria:

* none

Primary outcomes:
measure: Recurrence free outcome
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pontiac
country: United States
facility: St.Joseph Mercy Oakland Pontiac
state: Michigan
Study officials:
affiliation: St.Joseph Mercy Oakland Pontiac
name: Narendra Tyagi, MD FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00886860: The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol
Official title: The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Ripening
Labor Induction
Keywords: Efficacy
Cervical ripening/Labor induction
Titrated oral misoprostol/Conventional oral misoprostol
Term pregnancy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2009-04-23
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol


Eligibility criteria: Inclusion Criteria:

* age 18 years old or more
* singleton pregnancy at 37 weeks gestation or more
* cephalic presentation
* reassuring fetal heart rate pattern
* admission for labor induction due to medical or obstetrical conditions
* bishop score less than 6
* giving consent and having signed the consent form for this study

Exclusion Criteria:

* parity more than 3
* estimated fetal weight more than 3,500 grams
* non-reassuring fetal heart rate pattern
* having contraindication for vaginal delivery
* previous uterine scar
* suspected abruptio placenta with non-reassuring fetal heart rate pattern
* abnormal bleeding per vagina, except bloody show
* PROM
* having underlying cardiac, hepatic, or renal diseases
* having history of allergy to misoprostol or prostaglandin analogues
* cervical dilatation 3 centimeters or more
* uterine contraction 3 times or more in 10 minute

Primary outcomes:
measure: success rate of cervical ripening in labor induction
timeFrame: 12 hours after intervention
Secondary outcomes:
measure: number of vaginal delivery
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University
Study officials:
affiliation: Siriraj Hospital, Mahidol University Bangkok, Bangkok, Thailand
name: Kusol Russameecharoen, MD
role: STUDY_DIRECTOR
References:
citation: Thaisomboon A, Russameecharoen K, Wanitpongpan P, Phattanachindakun B, Changnoi A. Comparison of the efficacy and safety of titrated oral misoprostol and a conventional oral regimen for cervical ripening and labor induction. Int J Gynaecol Obstet. 2012 Jan;116(1):13-6. doi: 10.1016/j.ijgo.2011.07.027. Epub 2011 Sep 28.
Clinical trial NCT00414960: A Trial of Placebo Versus Enzastaurin for Lung Cancer Prevention in Former Smokers
Official title: Phase IIB Randomized, Placebo-Controlled, Double-Blind Study of Enzastaurin HCL (LY317615) for Lung Cancer Prevention in Former Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: Healthy
Prevention
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-12-22
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the difference of a marker of cellular proliferation in all bronchial biopsy specimens of former smokers stratified by lung cancer risk, collected before and after treatment per patient between the enzastaurin and placebo groups.


Eligibility criteria: Inclusion Criteria:

* Sputum atypia participants with normal sputum cytology will be removed from the study)
* Metaplasia or dysplasia on at least one bronchoscopy specimen
* History of cigarette smoking ≥30 Pack Years
* Quit smoking ≥1 year prior to study entry
* Able to undergo bronchoscopy and helical computed tomography (CT) scanning of the chest
* Able to swallow tablets

Exclusion Criteria:

* Blood clotting abnormalities
* Current smoking within the past 1 year
* Unwillingness to abstain from smoking while enrolled in the clinical trial or unwillingness to avoid significant second hand smoke exposure
* Evidence for lung cancer or carcinoma in situ
* Active cardiovascular disease
* Current illicit drug or alcohol abuse

Primary outcomes:
measure: Change From Baseline in Percentage of Cells Staining Positive for Ki-67 in All Biopsy Specimens at Endpoint
timeFrame: Baseline, endpoint (up to 8 months)
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline through end of study (up to 32 months)
Other outcomes:
Locations:
city: Tampa
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01473160: Daily Disposable Contact Lens Tear Film Study
Official title: DAILIES TOTAL1 Pre-Lens Tear Film Performance - Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: Aston University
First posted: 2011-11-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked daily disposable contact lens as compared to a commercially available daily disposable contact lens.


Eligibility criteria: Inclusion Criteria:

* Be of legal age of consent and sign Informed Consent document.
* Willing and able to wear spherical contact lenses for 16 hours.
* Willing and able to wear spherical contact lenses within the available range of powers.
* Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Anterior segment infection, inflammation, or abnormality.
* Any use of systemic medications for which contact lens wear could be contraindicated.
* History of refractive surgery or irregular cornea.
* Currently enrolled in any clinical trial.
* Eye injury within twelve weeks prior to enrollment.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With Corrected Visual Acuity of 0.0 or Better
timeFrame: Up to 16 hours after lens insertion
measure: Pre-Lens Noninvasive Tear Break-Up Time
timeFrame: Up to 16 hours after lens insertion
measure: Average Tear Meniscus Height
timeFrame: Up to 16 hours after lens insertion
measure: Average Ocular Surface Temperature
timeFrame: Up to 16 hours after lens insertion
Secondary outcomes:
measure: Subjective Comfort
timeFrame: Up to 16 hours after lens insertion
measure: Subjective Vision
timeFrame: Up to 16 hours after lens insertion
measure: Number of Participants With Adequate Lens Fit
timeFrame: Up to 16 hours after lens insertion
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Aston University
Study officials:
References:
Clinical trial NCT02630160: The Influence of Local Infiltration Analgesia by Catheter in Postoperative Control Pain After Total Hip Replacement
Official title: The Influence of Local Infiltration Analgesia by Catheter in Postoperative Control Pain After Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Musculoskeletal Pain
Hip Injuries
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 100
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 double-blind clinical trial was performed. There were 4 groups according to catheter placement and infusion constituents: 1) Intraarticular catheter + anesthetics; 2) Intraarticular catheter +placebo; 3) Subfascial catheter + anesthetics; 4) Subfascial catheter + placebo. The anesthetics infusion contained bupivacaine (bolus + continuous perfusion up to 36 hours). The placebo solution consisted in physiological serum (bolus + continuous perfusion up to 36 hours). Randomization was performed in the hospital pharmacy and the surgeon kept out the surgical field when the resident placed the catheter. The same conventional analgesic schedule was prescribed to all patients: PCA (patient controlled analgesia) + paracetamol 1g/6h + dexketoprofen 50mg/12h. The pain was evaluated by means of PCA (patient controlled analgesia) shots and the VAS (visual analog scale). Side effects, time to start rehabilitation and time to discharge were also analyzed. A statistical analysis was performed to compare all this variables between the 4 groups (SPSS 18.0).


Eligibility criteria: Inclusion Criteria:

* Primary total Hip Replacement

Exclusion Criteria:

* Allergic to Bupivacaine

Primary outcomes:
measure: Change in pain measured with a visual analog scale
timeFrame: 36 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Hospital del Mar
name: Daniel Pérez Prieto
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Mar
name: Marta Cuenca Llavall
role: STUDY_CHAIR
affiliation: Hospital del Mar
name: Fernando Marques Lopez
role: STUDY_DIRECTOR
affiliation: Hospital del Mar
name: Alfonso Leon Garcia
role: STUDY_CHAIR
affiliation: Hospital del Mar
name: Francisco Javier Santiveri Papiol
role: STUDY_CHAIR
References:
Clinical trial NCT01278160: Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756
Official title: An Extension Trial of BIAsp-3756, Explorative Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens on the Effect of Glycaemic Control in Chinese Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-01-17
Enrollment: 179
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic control of biphasic insulin aspart 30 twice daily with two different dosage split regimens for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIASP-3756 (NCT01123980).


Eligibility criteria: Inclusion Criteria:

* Finalised 24 weeks of treatment with once daily BIAsp 30 or insulin glargine in combination with metformin and glimepiride in trial BIAsp-3756
* HbA1c above or equal to 7.0%
* Body Mass Index (BMI) below or equal to 40.0 kg/m2

Exclusion Criteria:

* Known hypoglycaemia unawareness or recurrent major hypoglycaemic episodes in trial BIAsp-3756
* Known proliferative retinopathy or maculopathy requiring acute treatment
* Any disease or condition which the Investigator (trial physician) feels would interfere with the trial

Primary outcomes:
measure: Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline
timeFrame: Week 0, week 16
Secondary outcomes:
measure: 9-point SMPG (Self Measured Plasma Glucose) Profile
timeFrame: Week 16
measure: Percentage of Subjects Achieving HbA1c Below 7.0%
timeFrame: Week 16
measure: Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
timeFrame: Week 16
measure: Number of Treatment Emergent Hypoglycaemic Episodes
timeFrame: Weeks 0-16
Other outcomes:
Locations:
city: Beijing
country: China
state: Beijing
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05561660: COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)
Official title: Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval (COMPETE-2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Migraine
Patent Foramen Ovale
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs have shown negative primary results, making it unclear whether PFO occlusion is effective in treating migraine. Our study is a prospective, double-blind, multi-center, and randomized study designed to test the effectiveness of migraine alleviation by performing percutaneous closure of patent foramen ovale in patients who are also diagnosed with PFO and migraine.


Eligibility criteria: Inclusion Criteria:

1. Age 18-65 ；
2. Diagnosed migraine by ICHD-3
3. History of migraine longer than 1 year
4. TCD/TTE/TEE diagnosed patent foramen ovale
5. Willing to participant and agree to follow-ups
6. Undertook medication therapy for three months without a responder rate higher or equal to 50%

Exclusion Criteria:

1. Migraine caused by other reason
2. Had TIA/stroke history
3. Hypersensitive or hyposensitive to the study drug

Primary outcomes:
measure: Responder rate
timeFrame: From baseline period to 12-month treatment period
measure: Treatment safety
timeFrame: From baseline period to 12-month treatment period
Secondary outcomes:
measure: Migraine days change per month
timeFrame: From baseline period to 12-month treatment period
measure: Number of migraine attacks change per month
timeFrame: From baseline period to 12-month treatment period
measure: Percentage of migraine change
timeFrame: From baseline period to 12-month treatment period
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
References: