louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00383591: Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
Official title: A Phase III, Clinical Trial Comparing the Persistence of GSK Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B at Months 24, 30, 36, in Pre-haemodialysis/Haemodialysis Patients (≥15 Years of Age)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-03
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Persistence of anti-HBs antibodies at Month 24, 30 and 36 in subjects who had completed primary vaccination was evaluated. The anamnestic response to a booster dose was evaluated in subjects with anti-HBs antibody titres \< 10 mIU/ml at previous timepoint. The study also evaluated the effect of a booster dose of the vaccine (Month 42) after primary vaccination.


Eligibility criteria: Inclusion Criteria:

* Subjects were to have completed primary vaccination course. A male or female \> = 15 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject/ from the parents or guardians of the subject.
* If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she was to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
* Pregnant or lactating female.

Primary outcomes:
measure: Anti-HBs seroprotection
measure: Response to booster
Secondary outcomes:
measure: Solicited, unsolicited symptoms and serious adverse events
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: GSK Investigational Site
city: Bandar Tun Razak, Cheras
country: Malaysia
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00417391: Phase II Study of RR110 in Patients With Active Crohn's Disease
Official title: Phase II Study of RR110 in Patients With Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: R&R Inc.
Sponsor class: INDUSTRY
First posted: 2007-01-01
Enrollment: 24
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 safety, efficacy and pharmacokinetics profile of 1 and 4 mg/kg/day RR110 administrated orally for 8 weeks in patients with active Crohn's disease.


Eligibility criteria: Inclusion Criteria:

* Patients with CDAI score ranging from 220 to 450
* Patients with CRP \> 1 mg/dL
* Patients who can be hospitalized at least 2 weeks after first administration

Exclusion Criteria:

* Patients who have previously used anti-TNF antibody, cyclosporine, methotrexate or tacrolimus within 12 weeks of screening
* Patients who have had surgical bowel resections within 4 weeks of screening
* Patients who have previously used total parental nutrition or more than 900 kcal/day of enteral nutrition within 4 weeks of screening

Primary outcomes:
measure: Change in Crohn's disease active index (CDAI) score
timeFrame: 8 weeks
Secondary outcomes:
measure: Rate of clinical response as defined by CDAI decrease > 70 or 100 from baseline
timeFrame: 8 weeks
measure: Rate of clinical remission as defined by CDAI < 150
timeFrame: 8 weeks
measure: Change in CRP, SAA, and fibrinogen levels, and IBDQ and CDEIS scores
timeFrame: 10 weeks
measure: Safety parameters
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Toyohashi
country: Japan
state: Aichi
city: Sakura
country: Japan
state: Chiba
city: Sapporo
country: Japan
state: Hokkaido
city: Nishinomiya
country: Japan
state: Hyogo
city: Fujisawa
country: Japan
state: Kanagawa
city: Nakagami
country: Japan
state: Okinawa
city: Otsu
country: Japan
state: Shiga
city: Shinjuku
country: Japan
state: Tokyo
Study officials:
affiliation: Keio University
name: Toshifumi Hibi, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00975091: Continue Entecavir Rollover From China
Official title: A Study of the Safety and Antiviral Activity of Open-Label Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection Who Have Completed Dosing in a Previous Phase II/III Study in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis B Virus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-09-11
Enrollment: 600
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if treatment with entecavir is safe and well tolerated in patients who completed dosing in a previous entecavir study in China, but are requiring further treatment of their chronic hepatitis B virus infection.


Eligibility criteria: Inclusion Criteria:

* Subjects who had completed the required dosing period in a previous ETV Phase 2 or 3 study in China (studies AI463012, AI463023, AI463056), and had been assessed by the Investigators as likely to benefit from additional therapy for treatment of their HBV infection
* ALT ≤ 15 x upper limit of normal
* Compensated liver disease

Exclusion Criteria:

* Coinfection with HIV, HCV, or HDV

Primary outcomes:
measure: The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events
timeFrame: Through 3 years of dosing and up to 48 weeks of off treatment follow up
Secondary outcomes:
measure: The change in the mean HBV DNA measured by PCR assay from baseline for each entecavir cohort
timeFrame: Through 3 years of dosing
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06142591: Oxycodone (10, 20 mg) in a Postoperative Dressing
Official title: Oxycodone (10, 20 mg) in a Postoperative Dressing in Patients After Surgical Debridement of Burn Wounds. A Prospective, Double-blinded, Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Burns
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study mainly focuses on pain management using 10- or 20mg oxycodone burn wound dressing at Poznan University of Medical Sciences.

Detailed description: Subjects were randomly assigned to one of the two treatment groups, A and B. Patients scheduled for burn surgery will sign written consent pre-operatively about procedural pain management. Group A received 10mg of oxycodone in wound dressing, while those in Group B received 20mg of oxycodone in wound dressing.

Eligibility criteria: Inclusion Criteria:

* adults scheduled for surgical burn treatment
* aged \> 18 years
* ASA physical status 1,2 or 3

Exclusion Criteria:

* opioid abuse
* ASA physical status 4, 5

Primary outcomes:
measure: Serum morphine concentration level [ng/ml]
timeFrame: Measured on the day of the procedure
Secondary outcomes:
measure: NRS score
timeFrame: Measured on the day of the procedure
Other outcomes:
measure: Dressing morphine concentration [mg/ml]
timeFrame: Measured on the day of the procedure
Locations:
Study officials:
affiliation: Poznań University of Medical Sciences
name: Katarzyna Wieczorowska-Tobis, Prof.dr hab
role: STUDY_DIRECTOR
References:
Clinical trial NCT02174991: A Compassionate Case Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Glaucoma Patients With Uncontrolled Intraocular Pressure to Avoid Surgical Intervention
Official title: A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Glaucoma Patients With Uncontrolled Intraocular Pressure to Avoid Surgical Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glaucoma
Lead sponsor: New York Glaucoma Research Institute
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A. To evaluate the ocular hypotensive efficacy of the rho-kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in open-angle glaucoma patients with uncontrolled IOP who are facing surgical intervention. Patients will be treated for 6 months in this initial trial.

B. To evaluate the efficacy of AR-12286 in enabling treated patients to delay or avoid the necessity of surgical intervention.


Eligibility criteria: Inclusion Criteria:

1. Patients with open-angle glaucoma.
2. IOP above the target range or visual field progression with use of maximum standard drug therapy.
3. Have given written informed consent, prior to any investigational procedures.
4. Ability to attend for the 6-month duration of treatment.

Exclusion Criteria:

1. Angle-closure glaucoma
2. Eyes having had previous incisional glaucoma surgery
3. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
4. Ocular medication of any kind within 30 days of base-line visit, with the exception of ocular hypotensive medications and/or lubricating drops for dry eye (which may be used throughout the study).
5. Any abnormality preventing reliable applanation tonometry of the treated eye.
6. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
7. Participation in any investigational study within the past 30 days.
8. Inability to perform reliable visual field testing.
9. Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary.
10. Self-reported poor compliance to treatment.
11. Reluctance to return for scheduled follow-up visits.
12. Patients not able to understand the nature of the study.

Primary outcomes:
measure: IOP Reduction
timeFrame: 6 Months
Secondary outcomes:
measure: Tolerance and Lasting IOP Effect
timeFrame: 6 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: Glaucoma Associates of New York
state: New York
Study officials:
References:
Clinical trial NCT03035591: ODM-207 in Patients With Advance Solid Tumours
Official title: Safety and Pharmacokinetics of ODM-207 in Patients With Selected Advanced Solid Tumours: an Open-label, Non-randomised, Uncontrolled, Multicentre, First-in-human Study With Cohort Expansion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2017-01-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a first-in-man study to assess the safety and tolerability and to characterise the pharmacokinetics of ODM-207.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically or cytologically confirmed locally advanced or metastatic cancer for which no effective standard therapy exists or are refractory or resistant to conventional therapy
* Life expectancy \>12 weeks
* Patient may have either measurable or non-measurable disease, but must have disease that can be evaluated for improvement of progression
* ECOG performance status of 0 to 1

Exclusion Criteria:

* History of bleeding disorder or significant bleeding episode within 6 months prior to study treatment
* Subjects receiving anticoagulants or medications that durably inhibit platelet function (7-day wash-out prior to study treatment)
* History of or current leptomeningeal or brain metastasis or spinal cord compression.

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital, Department of Oncology
Study officials:
affiliation: ICR/Royal Marsden
name: Johann De Bono
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ameratunga M, Brana I, Bono P, Postel-Vinay S, Plummer R, Aspegren J, Korjamo T, Snapir A, de Bono JS. First-in-human Phase 1 open label study of the BET inhibitor ODM-207 in patients with selected solid tumours. Br J Cancer. 2020 Dec;123(12):1730-1736. doi: 10.1038/s41416-020-01077-z. Epub 2020 Sep 29.
Clinical trial NCT06695091: Clinical Assessment of Endodontically Treated Posterior Teeth Prepared With Two Occlusal Designs and Two Ceramic Full Coverage Restorations
Official title: Clinical Assessment of Endodontically Treated Posterior Teeth Prepared With Two Occlusal Designs and Two Ceramic Full Coverage Restorations (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Clinical Behavioral
Keywords: Lithium disilicate
Zirconia
All-ceramic crowns
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to assess the impact of flat occlusal preparation design (FOD) of endodontically treated molars on the fracture resistance and distribution of stresses among a ceramic crown-molar structure when compared to two planes occlusal preparation design (TOD).


Eligibility criteria: Inclusion Criteria:

* Patients with posterior root canal treated teeth that require full coverage restoration.
* 20 - 50 years old.
* Males or Females.
* Good oral hygiene.
* Presence of favorable occlusion and teeth are in normal alignment with the adjacent teeth.
* Patients agreed to return to follow-up evaluation.

Exclusion Criteria:

* Active periodontal or pulpal diseases.
* Lack of opposing dentition.
* Severe medical complications.
* Pregnancy.
* Lack of compliance.
* Evidence of parafunctional habits
* Temporomandibular joint disorders

Primary outcomes:
measure: Fracture
timeFrame: 12 months
Secondary outcomes:
measure: Marginal adaptation
timeFrame: 12 months
measure: Marginal discoloration
timeFrame: 12 months
measure: Secondary caries
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Lecturer of Fixed Prosthodontics
name: Sameh Abou-Steit, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mannocci F, Cowie J. Restoration of endodontically treated teeth. Br Dent J. 2014 Mar;216(6):341-6. doi: 10.1038/sj.bdj.2014.198.
citation: Varlan C, Dimitriu B, Varlan V, Bodnar D, Suciu I. Current opinions concerning the restoration of endodontically treated teeth: basic principles. J Med Life. 2009 Apr-Jun;2(2):165-72.
citation: Beier US, Kapferer I, Dumfahrt H. Clinical long-term evaluation and failure characteristics of 1,335 all-ceramic restorations. Int J Prosthodont. 2012 Jan-Feb;25(1):70-8.
citation: Nagasiri R, Chitmongkolsuk S. Long-term survival of endodontically treated molars without crown coverage: a retrospective cohort study. J Prosthet Dent. 2005 Feb;93(2):164-70. doi: 10.1016/j.prosdent.2004.11.001.
citation: Oyar P, Ulusoy M, Eskitascioglu G. Finite element analysis of stress distribution in ceramic crowns fabricated with different tooth preparation designs. J Prosthet Dent. 2014 Oct;112(4):871-7. doi: 10.1016/j.prosdent.2013.12.019. Epub 2014 Apr 21.
Clinical trial NCT05770791: Comparative Effects of Using Black Seed and Cumin Seed on BCP of Obese Grade I
Official title: Comparative Effects of Using Black Seed (Nigella Sativa) and Cumin Seed ( Cuminum Cyminum) on Body Composition Profile of Obese Grade I
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Obese
Keywords: Cumin Seeds
Black seed
Obese grade I
Lead sponsor: Sehat Medical Complex
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 55
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this Randomized clinical trial is to compare effectiveness of of using black seed (Nigella sativa) and cumin seed (Cuminum cyminum) on Body composition profile of obese grade 1. The primary objective of this study is To compare effectiveness of of using black seed (Nigella sativa) and cumin seed (Cuminum cyminum) on Body composition profile of obese grade 1. Subjects will be given a consent form and after subjects read and sign the informed consent, they would be included in study according to eligibility criteria.

Detailed description: Obesity is a global pandemic that is associated with high morbidity and mortality. Natural herbs are commonly used for weight reduction and appetite suppression. Worldwide data based on 1698 studies has shown that the global prevalence of obesity has increased from 3.2 to 10.8% in men and from 6.4 to 14.9% in women. Meanwhile, herbal products are marketed for their weight-loss properties, such as Nigella sativa which has been used for centuries to treat rheumatoid arthritis, diabetes, and asthma; recently, the anti-obesity characteristics of N. sativa have also been indicated. The antihyperglycemic activity, inhibition of free radical formation, anti-obesity and anti-inflammatory activity of cumin seed extract have also been reported previously.

Eligibility criteria: Inclusion Criteria:

* Subject having BMI between 30 kg/m2 - 34.5 kg/m2

Exclusion Criteria:

* Subjects having kidney or liver problems
* Having ulcers in GIT
* Subjects having hypertension, thyroid, diabetes or cardiovascular disorders
* Pregnant and lactating mothers
* Subjects who are using hormonal or anti-obesity medications

Primary outcomes:
measure: Body Composition Profile
timeFrame: Change from baseline at 30th Day
Secondary outcomes:
measure: BMI
timeFrame: Change from Baseline at 30th Day
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sehat Medical Complex, Lahore
state: Punjab
Study officials:
affiliation: University of Lahore
name: Momina Mehmood
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01602991: Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery
Official title: Sensitivity, Specificity, and Positive and Negative Predictive Values of Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Endoscopy
Nasopharyngoesophagogastroscopy
Bariatric Surgery
Gastric Bypass Surgery
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Vantage Endoscopy
First posted: 2012-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to determine that this new technology, nasopharyngoendoscopy, is just as effective in diagnosing problems as the current gold standard.

Detailed description: Obesity is a public health problem. Currently, the best treatment is surgery. However, 15% of patients after surgery have problems such as nausea, pain, vomiting, heartburn or regurgitation. To investigate these problems, an endoscopy is used. Yet, endoscopy has some disadvantages such as the need for intravenous sedation, need to take time off work, need for special endoscopy units and nurses and a delay in diagnosing because the endoscopy cannot be done at the time of the clinic visit. A new technology called clinic-based nasopharyngoendoscopy can potentially solve many of the problems with the current endoscopy. This study aims to determine that this new technology is just as effective in diagnosing problems as the current gold standard.

Eligibility criteria: Inclusion Criteria:

* Post-operative gastric bypass patients at St. Joseph's Healthcare Hamilton
* No previous nasal or pharyngeal surgery
* Foregut dyspeptic symptoms including: nausea, vomiting, regurgitation, epigastric pain, reflux and/or hematemesis
* Require endoscopy for investigation of foregut symptoms
* Able to provide consent

Exclusion Criteria:

* Patients who have not undergone gastric bypass surgery
* Inability to give consent

Primary outcomes:
measure: Sensitivity, specificity, and positive and negative predictive values of in-office transnasal esophagoscopy in evaluating symptomatic, post-operative bariatric surgery patients.
timeFrame: Approximately 8 weeks
Secondary outcomes:
measure: Complications of standard and in-office transnasal esophagoscopy
timeFrame: approximately 8 weeks
measure: Differences in in-hospital resource use between standard endoscopy and office-based transnasal nasopharyngoendoscopy
timeFrame: Approximately 8 weeks
measure: How well patients tolerate in-office transnasal esophagoscopy
timeFrame: Immediately following transnasal esophagoscopy
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Dennis Hong, MD
role: PRINCIPAL_INVESTIGATOR
References: