louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02131636: Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erythema
Rosacea
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-05-06
Enrollment: 440
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: This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.


Eligibility criteria: Inclusion Criteria:

-Moderate to severe persistent facial erythema associated with rosacea.

Exclusion Criteria:

* Greater than 3 inflammatory lesions on the face
* Current treatment with monoamine oxidase (MAO) inhibitors
* Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.

Primary outcomes:
measure: Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales
timeFrame: Baseline, Day 29 (Hours 3, 6, 9, and 12)
Secondary outcomes:
measure: Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale
timeFrame: Baseline, Day 29 (Hours 3, 6, 9, and 12)
measure: Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)
timeFrame: Baseline, Day 29 (Hours 3, 6, 9, and 12)
measure: Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9
timeFrame: Day 29 (Hours 3, 6, 9, and 12)
measure: Change From Baseline on the SA-RFR Questionnaire Item #4
timeFrame: Baseline, Day 29 (Hours 3, 6, 9, and 12)
measure: Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale
timeFrame: Baseline, Day 1 (Hour 1)
Other outcomes:
Locations:
city: Lynchburg
country: United States
state: Virginia
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02181036: Effects of Work Shop for Children With Developmental Delays
Official title: Effects of Family Work Shop for Children With Speech Developmental Delays
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Delays
Keywords: Family work shop
speech developmental delays
children
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2014-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To identify the effects of family work shop for children with speech developmental delays.

Detailed description: To assess the improvement of functional performance of children with speech developmental delays by 2-3 hours per session, one session per week, a total of 6 weeks of family work shop

Eligibility criteria: Inclusion Criteria:

* 18 M/O to 36 M/O of children with speech development delay

Exclusion Criteria:

* less than 18 M/O older than 36 M/O

Primary outcomes:
measure: changes of pediatric health related quality of life (Pediatric Quality of Life Inventory)
timeFrame: participants will be evaluated at before and after 6 weeks of work shop
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Taipei Medical University
name: Ru-Lan Hsieh, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01441336: Laparoscopic Gastrectomy for Advanced Gastric Cancer
Official title: Laparoscopic Gastrectomy for Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Gastric Cancer
Laparoscopic Gastrectomy
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2011-09-27
Enrollment: 204
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Although laparoscopic gastrectomy (LG) is widely used for the treatment of early gastric cancer, there have been few reports of the efficacy of LAG in the management of advanced gastric cancer(AGC). The aim of this study is to evaluate the surgical outcomes and oncologic safety of laparoscopic gastrectomy for AGC.

Detailed description: Prospective phase II clinical trial to evaluate technical and oncological safety of LG for AGC

LG procedure for AGC:

D2 lymphadenectomy Total omentectomy for tumor with serosa exposure under laparoscopic exploration

Primary end point: 3 year disease free survival secondary end point: postoperative outcomes, morbidity and mortality, 3,5 and 7 year overall survival, Quality of life, recurrence pattern

Study duration: 7 years(enrollment: 4year, follow-up: 3year)

Eligibility criteria: Inclusion Criteria:

* Age 20-80
* informed consent
* no other malignancies
* cT2N0-cT3N2 according to JGCA 2nd edition
* ASA score\<3

Exclusion Criteria:

* distant metastasis(P1 or M1) under laparoscopic exploration
* Conglomerated N2
* early gastric cancer in permanent pathologic report

Primary outcomes:
measure: 3 year recurrence free survival
timeFrame: Postoperative 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
citation: Zhang L, Hong H, Zang L, Dong F, Lu A, Feng B, He Z, Xue P, Cai Z, Zheng M, Ma J. Application Value of 4K High-Definition System in Laparoscopic Gastrectomy: Preliminary Results and Initial Experience. J Laparoendosc Adv Surg Tech A. 2022 Feb;32(2):137-141. doi: 10.1089/lap.2020.0931. Epub 2021 May 7.
citation: Ahn SH, Kang SH, Lee Y, Min SH, Park YS, Park DJ, Kim HH. Long-term Survival Outcomes of Laparoscopic Gastrectomy for Advanced Gastric Cancer: Five-year Results of a Phase II Prospective Clinical Trial. J Gastric Cancer. 2019 Mar;19(1):102-110. doi: 10.5230/jgc.2019.19.e6. Epub 2019 Mar 12.
citation: Lee JH, Son SY, Lee CM, Ahn SH, Park DJ, Kim HH. Morbidity and mortality after laparoscopic gastrectomy for advanced gastric cancer: results of a phase II clinical trial. Surg Endosc. 2013 Aug;27(8):2877-85. doi: 10.1007/s00464-013-2848-0. Epub 2013 Feb 13.
Clinical trial NCT00641836: Safety and Feasibility of Autologous Endothelial Progenitor Cells Transplantation in Patients With Idiopathic Pulmonary Arterial Hypertension
Official title: One-Year Follow-Up of Autologous Endothelial Progenitor Cells Transplantation in Patients With Idiopathic Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Arterial Hypertension
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2008-03-24
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Recent researches indicate that impairment of vascular and endothelial homeostasis plays a major role in the initiation and development of IPAH.We have recently reported the safety and feasibility data for autologous endothelial progenitor cells (EPCs) injection in patients with IPAH. Yet many questions remain unanswered: what is the ideal quantity of EPCs for therapy, the duration of the therapeutic effect, and moreover, the potential toxicity of such therapy. To help answer these questions, we designed the one year follow-up to investigate the safety and efficacy of autologous EPCs injection in patients with IPAH.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria included a base-line six minute walking distance between 100 and 450 m
* A resting mean pulmonary-artery pressure greater than 30 mm Hg
* A pulmonarycapillary wedge pressure of less than 15 mm Hg
* Pulmonary vascular resistance greater than 240 dyn•sec•cm-5
* 18-60 years old

Exclusion Criteria:

* The exclusion criteria included secondary pulmonary hypertension as a result of heart disease
* Pulmonary disease
* Sleep-associated disorders
* Chronic thromboembolic disease
* Autoimmune or collagen vascular disease
* HIV infection
* Liver disease
* New York Heart Association functional class IV
* Major bleeding requiring blood transfusion
* Diabetes
* Renal dysfunction
* Evidence for malignant diseases were excluded

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Cardiology, the First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Junzhu Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang XX, Zhang FR, Shang YP, Zhu JH, Xie XD, Tao QM, Zhu JH, Chen JZ. Transplantation of autologous endothelial progenitor cells may be beneficial in patients with idiopathic pulmonary arterial hypertension: a pilot randomized controlled trial. J Am Coll Cardiol. 2007 Apr 10;49(14):1566-71. doi: 10.1016/j.jacc.2006.12.037. Epub 2007 Mar 27.
Clinical trial NCT00299936: Comparison of PEG-Intron and Two Different Doses of Ribavirin for the Treatment of Chronic Hepatitis C In Treatment Naïve Subjects
Official title: Comparison of PEG Interferon Alfa-2b Plus Ribavirin Given as a Fixed Dose or on a Weight Optimized Basis for Treatment of Chronic Hepatitis C in Previously Untreated Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: hepatitis C
chronic hepatitis C
ribavirin
WIN-R
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2006-03-07
Enrollment: 5000
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: The purpose of this study is to compare PEG-interferon alfa-2b and two different doses of rivavirin for the treatment of chronic hepatitis C in previously untreated adult subjects

Detailed description: Primary Objective:

This study will evaluate the safety and efficacy of two different PEG-interferon and Ribavirin regimens in patients who have not previously been treated for Hepatitis C. Patients have an equal chance to assignment to one of two treatment arms:

Treatment Arm A:

PEG-interferon 1.5 mcg/kg2 QW + Ribavirin 800 mg/day

OR

Treatment Arm B:

PEG-interferon 1.5mcg/kg2 QW + Ribavirin 800 to 1400 mg/day

Arm A \& Arm B: Duration of treatment will be 48 weeks for genotype 1 patients and 24 or 48 weeks for genotype 2 or 3 patients.

Eligibility criteria: Adult naive subjects with a diagnosis of compensated chronic hepatitis C (HCV RNA+) who have not previously been treated with interferon, PEG-interferon, ribavirin, or combination interferon + ribavirin are being selected for the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Weill Medical College of Cornell University
name: Ira M Jacobson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hu KQ, Freilich B, Brown RS, Brass C, Jacobson IM. Impact of Hispanic or Asian ethnicity on the treatment outcomes of chronic hepatitis C: results from the WIN-R trial. J Clin Gastroenterol. 2011 Sep;45(8):720-6. doi: 10.1097/MCG.0b013e31820d35e3.
citation: Jacobson IM, Brown RS Jr, McCone J, Black M, Albert C, Dragutsky MS, Siddiqui FA, Hargrave T, Kwo PY, Lambiase L, Galler GW, Araya V, Freilich B, Harvey J, Griffel LH, Brass CA; WIN-R Study Group. Impact of weight-based ribavirin with peginterferon alfa-2b in African Americans with hepatitis C virus genotype 1. Hepatology. 2007 Oct;46(4):982-90. doi: 10.1002/hep.21670.
citation: Jacobson IM, Brown RS Jr, Freilich B, Afdhal N, Kwo PY, Santoro J, Becker S, Wakil AE, Pound D, Godofsky E, Strauss R, Bernstein D, Flamm S, Pauly MP, Mukhopadhyay P, Griffel LH, Brass CA; WIN-R Study Group. Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: a randomized trial. Hepatology. 2007 Oct;46(4):971-81. doi: 10.1002/hep.21932.
Clinical trial NCT01278836: Fasciocutaneous Flaps for Leg Defects
Official title: Study of Fasciocutaneous Flaps for Treatment of Leg Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Limb Defects
Keywords: Flap
leg defect
reconstruction
tissue
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of fasciocutaneous flaps for leg defects.

Detailed description: The fasciocutaneous flaps are tissue flaps which include skin, subcutaneous tissue, and the underlying fascia. Including the deep fascia with its prefascial and subfascial plexus enhances the circulation of these flaps. The investigators determined long-term outcomes of fasciocutaneous flap reconstruction in patients with lower limb defects.

Eligibility criteria: Inclusion Criteria:

* patients with leg defects

Exclusion Criteria:

* patients with underlying diseases

Primary outcomes:
measure: necrosis
timeFrame: at three years after surgery
Secondary outcomes:
measure: venous congestion
timeFrame: at three years after surgery
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Kashani University Hospital
Study officials:
affiliation: MD,research comittee
name: hamidreza shemshaki, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03097536: Migraine and Homeostasis:What Can we Learn From Glucose
Official title: Migraine and Homeostasis:What Can we Learn From Glucose
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Migraine Headache
Keywords: Blood Sugar
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with migraine often report that stressors such as skipping a meal can bring on a migraine whereas some patients report that their migraine improves with food. Few studies to date have looked at the relationship between blood glucose (sugar) and migraine. We are conducting this study to better understand whether or not changes in blood glucose levels can trigger migraine or provide relief during a migraine attack.

Detailed description: The purpose of this pilot and feasibility study is to assess if changes in blood glucose both trigger migraine and can provide analgesia. This information will provide a vital basis for the mechanism of migraine and offer insights into better treatments as well as prevention.

This is a pilot unblinded randomized trial with two independent components, Aims 1 and 2. It is not possible to blind the current protocol both in terms of the blood sugar readings and the luna bar, non-luna bar intervention.

Eligibility criteria: Inclusion Criteria:

* Male or female participants, age 18-65 with episodic migraine with or without aura (ICHD-II) and/or morning onset and/or patients who self identify that eating reduces their migraine intensity.

Exclusion Criteria:

* Chronic migraine, use of hypoglycemic medication, DM I or II, abnormal finger stick glucose, obesity, comorbid eating disorders, pregnancy, seizure disorder, other serious mental or physical condition that would impair participation in the study

Primary outcomes:
measure: The difference in blood glucose on days with migraine compared to blood glucose on days without migraine
timeFrame: Change Measure: migraine days and non-migraine days over 3 month period.
Secondary outcomes:
measure: The primary outcome is the change in pain score from the time of pain plateau to the pain score at 120 minutes as measured by a visual analogue scale.
timeFrame: Change Measure: migraine days and non-migraine days over 3 month period.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medial Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Alexandra Hovaguimian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01922336: Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects
Official title: A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Infliximab (SB2, EU Sourced Remicade® and US Sourced Remicade®) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-14
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy female subjects of non-childbearing potential and healthy male subjects
* Have a body weight between 60.0 and 94.9 kg and a body mass index between 20.0 and 29.9 kg/m², inclusive.

Exclusion Criteria:

* history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference IP formulation or comparable drugs.
* active or latent Tuberculosis or who have a history of Tuberculosis.
* history of invasive systemic fungal infections or other opportunistic infections
* systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
* serious infection associated with hospitalisation and/or which required intravenous antibiotics
* history of and/or current cardiac disease
* have received live vaccine(s) within 30 days prior to Screening or who will require live vaccine(s) between Screening and the final study visit.
* Intake medication with a half-life \> 24 h within 1 month or 10 half-lives of the medication prior to the administration of investigational product.

Primary outcomes:
measure: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
timeFrame: 71 days
measure: Maximum Serum Concentration (Cmax)
timeFrame: 71 days
measure: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
timeFrame: 71 days
Secondary outcomes:
measure: Time to Cmax (Tmax)
timeFrame: 71 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel International GmbH
Study officials:
affiliation: Parexel
name: Rainard Fuhr, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shin D, Kim Y, Kim YS, Kornicke T, Fuhr R. A Randomized, Phase I Pharmacokinetic Study Comparing SB2 and Infliximab Reference Product (Remicade((R))) in Healthy Subjects. BioDrugs. 2015 Dec;29(6):381-8. doi: 10.1007/s40259-015-0150-5.
Clinical trial NCT00150436: To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Postherpetic Neuralgia.
Official title: An Open-Label Extension Safety and Efficacy Study of Pregabalin in Patients With Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuralgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate long-term safety and efficacy of pregabalin in patients with postherpetic neuralgia.


Eligibility criteria: Inclusion Criteria:

* Must have met the inclusion criteria for preceding double-blind BID study in postherpetic neuralgia
* Must have received pregabalin/placebo under double-blind conditions for a minimum of 3 weeks.

Exclusion Criteria:

* Patients cannot participate if they experienced a serious adverse event during preceding double-blind BID study which was determined to be related to the study medication.

Primary outcomes:
measure: Safety Efficacy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05185336: Ultrasound Assessed Gastric Volume in the Fasted Pediatric Cerebral Palsy Patients
Official title: Ultrasound Assessment of Gastric Volume and Aspiration Risk Evaluation in the Fasted Pediatric Cerebral Palsy Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 38
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with cerebral palsy under the age of 18 scheduled surgery under general anesthesia

Brief summary: In patients with cerebral palsy, delayed gastric emptying and esophageal sphincter dysfunction are very commonly observed.

Pulmonary aspiration of gastric contents causes aspiration pneumonia, which greatly affects patients' prognosis, including hospital stay and mortality.

In the case of patients with cerebral palsy, there is a limitation in respiratory function, so more attention is required.

Therefore, this study aims to evaluate the risk of aspiration by measuring gastric volume after fasting for surgery in children with cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* patients with cerebral palsy under the age of 18 scheduled surgery under general anesthesia

Exclusion Criteria:

* the patient who feed through Levin tube or gastrostomy tube
* refusal to participate

Primary outcomes:
measure: gastric volume
timeFrame: preoperative 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References: