louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01493180: Exploratory Study of OPC-12759 Ophthalmic Suspension
Official title: Exploratory Study of OPC-12759 Ophthalmic Suspension in Patients With Keratoconjunctiva Epithelial Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Keratoconjunctival Epithelial Disorder
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-12-15
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also, safety of OPC-12759 is to be assessed.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of superficial punctate keratopathy, corneal erosion or persistent epithelial defect
2. Fluorescein corneal staining score of 3 or higher

Exclusion Criteria:

1. Active ocular infection
2. Vernal keratoconjunctivitis
3. Recurrent corneal erosion
4. Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or conjunctiva
5. Subjects who cannot discontinue or anticipate use of eye drops except for limited concomitant ones during the study. Soft-santear is allowed during the screening period.
6. Anticipated use of contact lens during the study.
7. Insertion of punctal plug or fall out of punctal plug within 3 months
8. Subjects who are judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease.
9. Receipt of any investigational product within 4 months.

Primary outcomes:
measure: Change in the Keratoconjunctival Staining Score From Baseline
timeFrame: Basekine, 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hachioji
country: Japan
facility: Kanto region
city: Ibaraki
country: Japan
facility: Kansai region
city: Ikoma
country: Japan
facility: Kansai region
city: Kobe
country: Japan
facility: Kansai Region
city: Kure
country: Japan
facility: Chugoku region
city: Kyoto
country: Japan
facility: Kansai region
city: Nagoya
country: Japan
facility: Tokai region
city: Osakasayama
country: Japan
facility: Kansai region
city: Osaka
country: Japan
facility: Kansai region
city: Tokyo
country: Japan
facility: Kanto region
Study officials:
affiliation: Division Dermatilogicals and Ophtalmolgicals, Otsuka Pharmaceutical Co., Ltd.
name: Eiji Murakami
role: STUDY_DIRECTOR
References:
Clinical trial NCT03931980: Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery
Official title: Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: rectal cancer
robotic surgery
laparoscopic surgery
Lead sponsor: Binh Dan Hospital
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Colorectal cancer is a common malignancy in Viet Nam. Laparoscopic surgery becomes a standard treatment in many centers. Today, robotic surgery is a new option for treating colorectal cancer with some advantages such as magnified 3D view, precise movements.

Answer on safety and feasibility of robotic surgery for colorectal cancer are not available in Viet Nam. Therefore, the investigators conducted a study " Robotic versus Laparoscopic Approach for Rectal Cancer Surgery".

Detailed description: Rectal cancer is a common surgical disease

Eligibility criteria: Inclusion Criteria:

* able to provide written informed consent
* Diagnosis of rectal cancer amenable to curative surgery by anterior resection, low anterior resection, ultra-low anterior resection, abdominal perineal resection, staged T1-T4a, N0-2, M0

Exclusion Criteria:

* Advanced cancer not amenable to curative surgery
* patient did not agree to participate in research

Primary outcomes:
measure: Conversion to open surgery
timeFrame: 1 day
Secondary outcomes:
measure: Time of surgery
timeFrame: 1 day
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Binh Dan hospital
Study officials:
affiliation: Binh Dan Hospital
name: Hung V Tran, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03055780: Diagnostic Accuracy to Detect Hemodynamically Significant Stenosis by Non-invasive SURECardio CT-FFR
Official title: Clinical Trial for SURECardio CT-FFR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Toshiba Medical Systems Corporation, Japan
Sponsor class: INDUSTRY
First posted: 2017-02-16
Enrollment: 59
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Suspected coronary artery disease

Brief summary: The aim of this study was to determine the diagnostic accuracy of SURECardio CT-FFR to detect functionally significant coronary stenosis.

Detailed description: CT acquision and invasive FFR measurement is performed for each patients. The diagnostic accuracy of coronary CTA and SURECardio CT-FFR is investigated using Invasive FFR is used as the reference standard.

Eligibility criteria: Inclusion Criteria:

* suspected coronary artery disease
* hemodynamically stable condition

Exclusion Criteria:

* hemodynamic instability
* atrial fibrillation
* morbid obesity (BMI≥40 kg/m2)
* previous stent implantation
* recent myocardial infarction (within 30 days)
* age \<40 years
* renal insufficiency (eGFR \<60mL/min/1.73m2)
* bronchospastic lung disease requiring long term steroid therapy

Primary outcomes:
measure: Sensitivity and specificity of SURECardio CT-FFR to detect functionally significant coronary stenosis
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06996080: A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE
Official title: A Randomized, Double-masked, Sham-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tabirafusp Alfa (KSI-101) in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Macular Edema Secondary to Inflammation
Keywords: MESI
macular edema
inflammatory macular edema
macular edema associated with inflammation
Lead sponsor: Kodiak Sciences Inc
Sponsor class: INDUSTRY
First posted: 2025-05-30
Enrollment: 150
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 Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)


Eligibility criteria: Inclusion Criteria:

* Patients with MESI, with a CST of ≥320 and \<400 microns on SD-OCT and a BCVA score of ≥25 and ≤78 ETDRS letters (between \~20/25 and 20/320 Snellen equivalent) in the Study Eye at Day 1;
* Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.

Exclusion Criteria:

* ME in the Study Eye secondary to diabetes, RVO, or wAMD
* Active or suspected ocular or periocular infection in either eye

Primary outcomes:
measure: Mean change in BCVA
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00034580: Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder
Official title: Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder, Manic or Mixed
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: Bipolar I Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-05-01
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a research study comparing the safety and efficacy of two active study medications for the treatment of bipolar I disorder.


Eligibility criteria: Inclusion Criteria:

* Male or female subject, 18-70 years of age
* Female subjects of childbearing potential must be using a medically accepted means of contraception
* Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol
* Subjects must be considered reliable

Exclusion:

* Female subjects who are either pregnant or nursing
* Uncorrected hypothyroidism or hyperthyroidism
* Narrow-angle glaucoma
* Subjects who present a serious and immediate risk of endangering him or herself

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkley
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: San Marcos
country: United States
state: California
city: Torrance
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Middleton
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Winter Park
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Hoffman Estates
country: United States
state: Illinois
city: Natick
country: United States
state: Massachusetts
city: St Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Clementon
country: United States
state: New Jersey
city: Olean
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: Madison
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Roanoke
country: United States
state: Virginia
Study officials:
References:
Clinical trial NCT01503580: Studies of Psychiatric Predisposing Factors, Treatment-related Cardiovascular Effects, and Prognostic Factors Associated With Antimuscarinic Drug (Tolterodine) for Female Overactive Bladder Syndrome
Official title: Studies of Psychiatric Predisposing Factors, Treatment-related Cardiovascular Effects, and Prognostic Factors Associated With Antimuscarinic Drug (Tolterodine) for Female Overactive Bladder Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antimuscarinic Drug
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-01-04
Enrollment: 155
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: Overactive bladder syndrome (OAB) affects around 17 % of female population. However, the etiology of OAB was complicated and unclear in many aspects. In particular, the research about psychiatric aspect of etiology in OAB was paucity. Besides, research about prognostic factors and impact of cardiovascular system of OAB treatment was also paucity. Therefore the aims of the investigators study were (1) to analyze the etiology of OAB in psychiatric aspects; (2) to analyze the prognostic factors associated with tolterodine treatment; (3) to analyze the differences of cardiac conduction and heart rate variability before and after tolterodine treatment; (4) to analyze the differences of arterial stiffness between non-OAB and OAB female patients, and before and after tolterodine treatment.


Eligibility criteria: Inclusion Criteria:

* all cases are female patients with lower urinary tract symptoms

Primary outcomes:
measure: Changes of heart rate variability after antimuscarinics
timeFrame: 3 months
Secondary outcomes:
measure: Changes of arterial stiffness after antimuscarinics treatment
timeFrame: 3 months
measure: Changes of psychologic distress after antimuscarinics treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Gynecology,National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT03231280: A Trial of a Single Delivery of SB-061 in Osteoarthritis of the Knee
Official title: A Placebo-controlled, Double-blind, Randomized Trial of a Single Intra-articular Delivery of SB-061 for the Treatment of Symptomatic Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis
Keywords: knee
Lead sponsor: Symic OA Co.
Sponsor class: INDUSTRY
Collaborators: name: Nordic Bioscience A/S
First posted: 2017-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee. Half of the patients will receive the agent via intra-articular injection and half will receive a placebo injection.

Detailed description: The treatment of pain associated with osteoarthritis may include periodic intra-articular injections of corticosteroids or viscosupplements such as hyaluronic acid. SB-061 is anticipated to relieve osteoarthritis pain by reinforcing the cartilage matrix and providing a lubricating coating of the cartilage. Subjects will receive 1 intra-articular injection of either SB-061 or placebo and be followed for 3 months to evaluate pain amelioration. Subjects and Investigators are blinded to treatment allocation.

Eligibility criteria: Inclusion Criteria:

* Femorotibial osteoarthritis of the knee
* Radiological OA Kellgren-Lawrence grade 2 or 3
* WOMAC Pain 1 score of the target knee of ≥4 and ≤ 9

Exclusion Criteria:

* Hypersensitivity to medications or to intra-articular injections
* Intra-articular delivery of corticosteroids or hyaluronic acid in the target knee within 6 months of study
* High dose systemic corticosteroid treatment of longer (\>14 days) duration w/in 6 months of study
* Major surgery or arthroscopy of the target knee within year prior to study
* Planned surgery in the target knee within the next 3 months
* Concomitant inflammatory disease affecting either knee

Primary outcomes:
measure: Pain
timeFrame: Baseline, 4 weeks
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Through 4 weeks
Secondary outcomes:
measure: Pain
timeFrame: Baseline, 4 weeks
measure: Physical function
timeFrame: Baseline, 4 weeks
measure: Pain
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: CCBR
city: Tartu
country: Estonia
facility: Medita Kliinik
Study officials:
affiliation: Symic OA Co.
name: Nathan Bachtell, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03805880: Cerebral Desaturation and Postoperative Dysfunction After Thoracic Surgery
Official title: Cerebral Desaturation During One Lung-ventilation and Postoperative Dysfunction Afterthoracic Surgery: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery
Cognitive Dysfunction
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients scheduled for elective lobectomy or wedge resection via thoracotomy requiring an OLV duration ≥ 45 min

Brief summary: The purpose of this study prospective observational study is to determine cognitive dysfunction incidence after thoracic surgery. We also evaluate evaluate the role of cerebral oxygen desaturations and hypertension as risk factors for post-operative cognitive dysfunction (POCD) in patients undergoing lung resection.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for elective lobectomy or wedge resection via thoracotomy
* one lung ventilation (OLV duration) ≥ 45 min

Exclusion Criteria:

* previous cerebral disease,
* dementia,
* severe cognitive dysfunction
* emergency surgery
* pregnancy
* patient refusal to give consent
* inability to give consent
* age ≤18 years
* ASA ≥ IV.

Primary outcomes:
measure: incidence of cognitive dysfunction after thoracic surgery
timeFrame: change of MMSE score from the day before surgery (baseline) at 1 day after surgery
Secondary outcomes:
measure: role of cerebral oxygen desaturations as risk factors for POCD in patients undergoing lung resection.
timeFrame: change of cerebral saturation from baseline(before surgery) at intraoperative measure
measure: role of hypertension as risk factors for POCD in patients undergoing lung resection.
timeFrame: change of blood pressure from baseline(before surgery) at intraoperative measure
Other outcomes:
Locations:
city: Roma
country: Italy
facility: azienda ospedaliero universitaria Sant'Andrea
Study officials:
References:
Clinical trial NCT03054480: Fractional Micro-Needle Radiofrequency and I Botulinum Toxin A for Primary Axillary Hyperhidrosis
Official title: A Comparative Study for Efficacy and Safety Between Fractional Micro-Needle Radiofrequency (FRM) and Intradermal Botulinum Toxin A for the Treatment of Primary Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Axillary Hyperhidrosis
Keywords: Fractional Micro-Needle Radiofrequency
Intradermal Botulinum Toxin A
Lead sponsor: Mae Fah Luang University Hospital
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: Because of the limiting data about an efficacy and safety of fractional radiofrequency for the treatment of hyperhidrosis, this study aim to compare clinical efficacy by Hyperhidrosis Disease Severity Score (HDSS) between Fractional Microneedle Radiofrequency device and intradermal Botulinum toxin type A injection for the treatment of primary axillary hyperhidrosis. The secondary objectives to determine the improvement change of iodine starch test, total amount of sweat production by trans-epidermal water loss (TEWL), patient's satisfaction and their quality of life by Dermatology Life Quality Index and side effect between the groups.


Eligibility criteria: Inclusion Criteria:

Male or female subjects, age between 18-60 years

* Healthy volunteers
* Subjects who have experienced with excessive sweating on both sides of axillary areas and have a positive result for iodine starch test on the screening day
* Willing to participant into the study and voluntary to sign in the informed consent form

Exclusion Criteria:

Active bacterial or fungal infection over tested area / axillae

* Pregnancy and breast feeding
* Previously underwent the surgical treatment such as radical resection of sweat glands for primary axillary hyperhidrosis
* Currently being treated with intradermal botulinum toxin type A injection at axillary area for less than 12 months
* Currently being inserted the cardiac pace maker or any other internal electronic devices
* Secondary hyperhidrosis caused by hyperthyroidism, drug induced, abnormal autonomic or neurological disorder that affect sweat gland
* Allergy to botulinum toxin type A
* Known contact allergy to iodine
* Unable to follow and comply to the study protocol

Primary outcomes:
measure: The change of Hyperhidrosis disease severity score (HDSS) at week-12 with the baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Iodine starch test
timeFrame: baseline, week 4 and week 12
measure: Participants' satisfaction assessment
timeFrame: week 4 and week 12
measure: Adverse effect
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02483780: We Talk About Our Hypertension
Official title: Culturally Adaptive Storytelling Method to Improve Hypertension Control in Vietnam -"We Talk About Our Hypertension": a Pilot Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Institute of Population, Health and Development, Vietnam
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
First posted: 2015-06-29
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The proposed pilot community-based research project will examine the feasibility, acceptability, and potential efficacy of the Storytelling intervention compared with usual care in hypertension control among rural residents in 4 communities in Vietnam. This is a major clinical and public health problem in this developing country.


Eligibility criteria: Inclusion Criteria:

Consenting adult men and women must fulfill each of the following criteria:

1. be a resident of the selected commune;
2. be aged 50 years or older;
3. have a diagnosis of hypertension according to the 7th Joint National Commission of High Blood Pressure (JNC 7)
4. not be cognitively impaired (as assessed by study physicians)
5. not be a "story teller" used to develop the intervention;
6. not be a family member of another participant in the study

Exclusion Criteria:

Primary outcomes:
measure: recruitment rate
timeFrame: 3 months
measure: retention rate
timeFrame: 1 year
Secondary outcomes:
measure: Blood pressure
timeFrame: 3 months after randomization
Other outcomes:
Locations:
city: Ha Noi
country: Vietnam
facility: Institute of Population, Health and Development (PHAD)
Study officials:
affiliation: Institute of Population, Health and Development
name: Hoa Nguyen, MD, Ph.D
role: STUDY_DIRECTOR
References:
citation: Nguyen HL, Ha DA, Goldberg RJ, Kiefe CI, Chiriboga G, Ly HN, Nguyen CK, Phan NT, Vu NC, Nguyen QP, Allison JJ. Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam- 12 month follow up results: A cluster randomized controlled feasibility trial. PLoS One. 2018 Dec 31;13(12):e0209912. doi: 10.1371/journal.pone.0209912. eCollection 2018.
citation: Nguyen HL, Allison JJ, Ha DA, Chiriboga G, Ly HN, Tran HT, Nguyen CK, Dang DM, Phan NT, Vu NC, Nguyen QP, Goldberg RJ. Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial. Pilot Feasibility Stud. 2017 May 1;3:22. doi: 10.1186/s40814-017-0136-9. eCollection 2017.
citation: Allison JJ, Nguyen HL, Ha DA, Chiriboga G, Ly HN, Tran HT, Phan NT, Vu NC, Kim M, Goldberg RJ. Culturally adaptive storytelling method to improve hypertension control in Vietnam - "We talk about our hypertension": study protocol for a feasibility cluster-randomized controlled trial. Trials. 2016 Jan 14;17:26. doi: 10.1186/s13063-015-1147-6.