louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03077581: Comparison of Three Techniques for Analgesia After Abdominoplasty
Official title: The Efficacy of Three Different Surgically Infiltrated Local Anesthetic Techniques in Abdominoplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominoplasty Patients
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted to demonstrate post-abdominoplasty analgesic duration consequent to three different surgically infiltrated LA techniques; bilateral TAPB, bilateral RSB and subcutaneous infiltration using the same volume of 0.25% bupivacaine (40 ml). Pain score, total analgesic rescue requests and the total amount of systemic rescue analgesia used in the first postoperative day in addition to any detected postoperative complications were also recorded.


Eligibility criteria: Inclusion Criteria:

* all patients listed for abdominoplasty

Exclusion Criteria:

* allergy to bupivacaine

Primary outcomes:
measure: morphine consumption (mg)
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dakahleya
Study officials:
References:
Clinical trial NCT01202981: Impact of Glistenings in AcrySof Intraocular Lenses on Visual Quality
Official title: Impact of IOL Glistenings on Visual Quality and Function in Patients Implanted With a Single-Piece AcrySof IOL That Exhibits Glistening Formation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lenses, Intraocular
Glistenings
Visual Quality
Keywords: glistenings
contrast sensitivity
visual quality
straylight
AcrySof IOL
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2010-09-16
Enrollment: 200
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: Enrollment will be stratified into two patient groups based on time since surgery: (1) one to two years post-operative, and (2) two to three years post-op.

Brief summary: This study will assess the impact of IOL glistenings on visual quality and function in patients implanted with a single-piece AcrySof intraocular lens (IOL) that exhibits glistening formations. The primary objective is to determine if random light scattering (measured by C-Quant)correlates with severity of glistenings, other objective measures of visual function (visual acuity, low contrast visual acuity, low contrast visual acuity with glare), and subjective measures of patients' perceptions of their visual quality after cataract surgery (quality of life survey, reports of symptomology and satisfaction).


Eligibility criteria: Inclusion Criteria:

1. Presence of obvious glistenings by slit lamp exam
2. Best spectacle corrected visual acuity of 20/20 or better on the Snellen chart at most recent exam

Exclusion Criteria:

1. Any central corneal pathology that could have impact on vision other than mild guttata felt unlikely to have any impact on corneal clarity.
2. Any documented glaucoma of any kind.
3. Any macular pathology except minimal drusen without retinal pigment epithelial pathology felt to be consistent with normal vision.
4. Any diabetic retinopathy other than minimal background diabetic retinopathy felt unlikely to affect vision.
5. Any other cause of central visual acuity loss including optic nerve, occipital cortex dysfunction or amblyopia.
6. Diagnosis of dry eye syndrome, defined as any corneal staining with fluorescein
7. Presence of any central posterior capsular opacification. Previous YAG laser capsulotomy is allowed.
8. Any surgical complication having to do with the capsule such as a broken capsule or zonular dialysis or iris trauma or any other complication felt to in any way impact upon the quality of the visual result.
9. Any contraindication to pupil dilation

Primary outcomes:
measure: Light scattering
timeFrame: Post-opertative
Secondary outcomes:
measure: Visual function
timeFrame: Post-operative
measure: Visual quality
timeFrame: Post-operative
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah, John Moran Eye Center
state: Utah
Study officials:
affiliation: University of Utah
name: Randall J Olson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06236581: Glycemic Excursion Minimization (GEM) to Outshine Health Disparities
Official title: Glycemic Excursion Minimization (GEM) to Outshine Health Disparities: RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Black
Continuous glucose monitoring
physical activity
carbohydrate
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: University of Virginia
name: University of Colorado, Denver
First posted: 2024-02-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial, intervention vs. waitlist
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if the GEM intervention is acceptable and helpful to Black adults with type 2 diabetes. The GEM intervention (coaching to reduce carbohydrate intake and increase physical activity after meals, with feedback from a continuous glucose monitor, CGM) might improve blood glucose levels, reduce diabetes distress, and increase empowerment and confidence in managing diabetes.

Detailed description: The purpose of the study is to test the feasibility, acceptability, and initial efficacy of the tailored GEM intervention among adult Black patients with type 2 diabetes, who are not on insulin or secretagogues.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* capable of making dietary and physical activity changes

Exclusion Criteria:

* on insulin or secretagogue
* on medications that impede weight loss (e.g., prednisone)
* pregnant or planning pregnancy in the next 2 months
* no history of moderate to severe hypoglycemia

Primary outcomes:
measure: Change from baseline on percent time in range from continuous glucose monitor at post-intervention
timeFrame: Baseline week and post-intervention week. From baseline week to the week after end of intervention or waitlist period, up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Prevention Institute
state: Georgia
Study officials:
affiliation: Augusta University
name: Catherine L Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06031181: Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019)
Official title: Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section: a Single-arm, Multi-center, Phase III Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lung Adenocarcinoma
Frozen Section
Sublobar Resection
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 390
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: TREATMENT

Brief summary: This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1019. The goal of this clinical trial is to confirm the therapeutic effect of sublobar resection for AIS/MIA diagnosed by intraoperative frozen section.


Eligibility criteria: Inclusion Criteria:

1. Patients who sign the informed consent form and are willing to complete the study according to the plan;
2. Aged from 18 to 80 years old;
3. ECOG equals 0 or 1;
4. Not receiving lung cancer surgery before;
5. Resectable peripheral cT1N0M0 tumors;
6. Single lung nodules with ground-glass dominant or pure ground-glass on CT, or multiple lung nodules with the major lesion being the aforementioned nodules;
7. Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section
8. Not receiving chemotherapy or radiotherapy before.

Exclusion Criteria:

1. Not cT1N0M0;
2. Cannot be completely resected by sublobar resection;
3. Invasive lung adenocarcinoma or not lung adenocarcinoma diagnosed cytologically or pathologically;
4. Receiving lung cancer surgery before;
5. Receiving radiotherapy or chemotherapy.

Primary outcomes:
measure: 5-year recurrence-free survival
timeFrame: 5 years
Secondary outcomes:
measure: 5-year overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT06534281: Pilot Study of BAO-G Technique in TAAA Endovascular Repair
Official title: Pilot Study of Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique in Thoracoabdominal Aortic Aneurysm Endovascular Repair
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Aortic Aneurysm, Thoracoabdominal
Keywords: BAO-G technique
thoracoabdominal aortic aneurysm
iliac-branched devices
endovascular repair
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-08-02
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: TREATMENT

Brief summary: Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique is a novel technique of endovascular repair of thoracoabdominal aortic aneurysm, which using off-the-shelf iliac branched devices to reconstruct the visceral branches. This study aims to evaluate the safety and efficacy of BAO-G in thoracoabdominal aortic aneurysm endovascular repair.


Eligibility criteria: Inclusion Criteria:

1. Patients with TAAA, confirmed by aortic CTA.
2. TAAA diameter ≥ 6cm, or symptomatic TAAA with diameter ≥ 4cm.
3. Informed consent signed.

Exclusion Criteria:

1. were pregnant.
2. had a history of previous endovascular or open repair.
3. had other contraindications of endovascular treatment.
4. Uncontrolled autoimmune disease.

Primary outcomes:
measure: Rate of visceral branch patency
timeFrame: Month 0, 3, 6, 12, and annually after surgery
measure: Incidence of endoleak
timeFrame: Month 0, 3, 6, 12, and annually after surgery
measure: Incidence of re-operation
timeFrame: Month 0, 3, 6, 12, and annually after surgery
Secondary outcomes:
measure: Incidence of organ ischemia
timeFrame: Month 0, 3, 6, 12, and annually after surgery
measure: Incidence of acute kidney injury
timeFrame: perioperative period
measure: Incidence of acute liver function injury
timeFrame: perioperative period
measure: Incidence of acute pancreatitis
timeFrame: perioperative period
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT06003881: Compassionate Use of Pozelimab in Patients With CD55-Deficient Protein-Losing Enteropathy
Official title: An Open-Label, Expanded Access Program of Pozelimab in Patients With CD55-Deficient Protein-Losing Enteropathy (CHAPLE Disease)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: CD55-Deficient Protein-Losing Enteropathy
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-08-22
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The program is to provide access to an experimental drug called pozelimab and to document the long-term safety of pozelimab in patients with Protein-Losing Enteropathy (PLE). CD55-deficient PLE/CHAPLE disease is a rare inherited disease of the immune system. This can be a life-threatening condition that is usually found when patients are children.


Eligibility criteria: Key Inclusion Criteria:

1. Clinical diagnosis of CD55-deficient PLE/CHAPLE disease (based on a history of PLE), confirmed by biallelic CD55 loss-of-function mutation detected by genotype analysis (frameshift, nonsense mutations) as defined in the protocol
2. Written informed consent from parent/guardian for minor patients
3. Written assent from minor patients as appropriate (eg, above the age of 6 years or the applicable age per local regulatory requirements)

Key Exclusion Criteria:

1. Patients who discontinued the prior pozelimab study due to safety or lack of efficacy
2. Considered by the treating physician as inappropriate for this program for any reason as defined in the protocol

NOTE: Other protocol defined inclusion / exclusion criteria apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01028781: Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis
Official title: Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Endometriosis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2009-12-09
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients will undergo a standard history and physical examination detailing objective clinical exam findings performed by one of the co-investigators. The research coordinator will obtain baseline values for intensity of pain, quality of life, and coping strategies. Baseline serum levels inflammatory markers will then be measured. Over the course of 12 weeks Thalidomide will be titrated as tolerated to achieve a minimum of a 30% reduction of pain on VAS from week 2.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years
2. Histologically/laparoscopically confirmed endometriosis
3. Chronic pelvic pain defined as non-menstrual pain for at least two weeks in the previous month for at least 6 months
4. VAS of 6 or more at baseline
5. Failure, completion or intolerance of standard treatment modalities (oral contraceptive therapy, danazol, Depo-Provera, Depo-Lupron)
6. Patients must give written informed consent.
7. Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program.

Exclusion Criteria:

1. Pregnant and/or lactating female
2. Users of other angiogenesis inhibitors
3. Current use of Rifampin, rifabutin, barbiturates, glucocorticoids, phenytoin, carbamazepine, chlorpromazine, reserpine, penicillin derivatives, or St. Johns Wart in user of oral contraceptive therapy
4. Use of aromatase inhibitors, Etanercept (Enbrel), GnRH agonists (Depo-Lupron), and Danazol within the past 3 months
5. Use of norethindrone acetate (Aygestin) in the prior month
6. Seizure disorder
7. Hepatitis, or any active infection (upper respiratory infection, PID, etc)
8. History of thromboembolic disease.
9. Baseline neutropenia (ANC \< 1000/mm\^3)
10. Any severe physical or metal illness that would interfere with the completion of the protocol
11. Illicit drug or alcohol abuse

Primary outcomes:
measure: pain report
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Denniz Zolnoun, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01342081: DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%
Official title: A Double-masked Study of DE-111 Ophthalmic Solution Versus Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5% in Patients With Primary Open Angle Glaucoma or Ocular Hypertension -Phase 3, Confirmatory Study-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open Angle Glaucoma
Ocular Hypertension
Keywords: Primary open angle glaucoma or ocular hypertension
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-04-26
Enrollment: 489
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: DE-111 ophthalmic solution will be evaluated for superiority in comparison with Tafluprost 0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and Timolol ophthalmic solution 0.5% used concomitantly, in IOP(intraocular pressure) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary open angle glaucoma or ocular hypertension
* Provided signed, written informed consent
* 20 years of age and older
* If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
* Presence of any abnormality or significant illness that could be expected to interfere with the study.

Primary outcomes:
measure: Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study
timeFrame: Week 0(Baseline) and Week 4(End of Study)
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Santen study sites
Study officials:
References:
Clinical trial NCT00051181: A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Chronic Angle-Closure Glaucoma
Official title: A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Chronic Angle-Closure Glaucoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma, Angle-Closure
Ocular Hypertension
Keywords: Glaucoma
POAG
OAG
OHT
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2003-01-07
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: To demonstrate that the intraocular pressure(IOP)-lowering efficacy of Travoprost (0.004%) is equal or better than that of Latanoprost 0.005% in patients with chronic angle-closure glaucoma.


Eligibility criteria: Adult patients of any race and either sex with chronic angle-closure glaucoma.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Asia
state: Texas
city: Sidney
country: Australia
facility: Australia
Study officials:
References:
Clinical trial NCT00992381: Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone
Official title: A Single Centre, Two Treatment, Two Period, Two Sequence, Randomized Crossover Steady-state Relative Bioavailability Study of Naproxen in Two Tablet Formulations Given Twice Daily (PN 400 Tablets Containing 500 mg of Naproxen Plus 20 mg of Esomeprazole Versus Naprosyn® Containing Naproxen 500 mg)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: GI Pain
healthy participants
Safety
bioavailability
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: POZEN
First posted: 2009-10-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether the absorption of naproxen from the PN 400 combination (Naprosyn and Esomeprazole) tablets is similar to that from the naproxen tablets (Naprosyn®), which are currently sold in Australia.


Eligibility criteria: Inclusion Criteria:

* Subjects must have a body weight greater than 50 kg and BMI within the range 18-30(inclusive).
* Subjects must be in good health, as assessed during pre-study medical examination and by review of screening results
* Subjects must understand the procedures involved and agree to participate in the study by giving fully informed, written consent

Exclusion Criteria:

* Significant intercurrent disease of any type, in particular liver, kidney, cardiovascular disease, any form of diabetes or significant gastrointestinal disorder which could affect drug absorption, or any history of gastric or duodenal ulceration.
* Ingestion of any naproxen, omeprazole, esomeprazole or related drugs prior to the recruitment interview, such that these drugs will have been ingested in the 4 weeks prior to the day set for the first Period 1 dose

Primary outcomes:
measure: To determine the relative naproxen bioavailability of PN 400 (naproxen 500 mg plus esomeprazole 20 mg) compared to an immediate release Naprosyn® 500 mg tablet
timeFrame: blood samples taken at various time points over 2 treatment periods of 11 days
Secondary outcomes:
measure: To evaluate the pharmacokinetic (PK) properties of the naproxen component of PN 400 tablet and immediate release Naprosyn® 500 mg tablet,
timeFrame: Blood samples taken at various time point over 2 periods of 2 days
measure: Compare the adverse event profile of PN 400 with that from Naprosyn®
timeFrame: Adverse event reporting over 2 periods of 11 days
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Research Site
state: Queensland
Study officials:
affiliation: Q-Pharm Phase one unit
name: Terry Hurst
role: STUDY_DIRECTOR
affiliation: Q-Pharm Phase one unit
name: Jo Marjason
role: PRINCIPAL_INVESTIGATOR
References: