louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02298400: A Clinical Study Comparing the Comfort of Three Commercially Available Contact Lenses
Official title: A Single-Center, Cross-over, Pilot Study Evaluating Acuvue® Oasys® Lenses (Senofilcon A), 30-Day Bausch + Lomb PureVision (Balafilcon A), and Clariti® 1-Day (Somofilcon A) Lenses, for Their Impact on Ocular Discomfort Induced by Exposure to the Turbo Controlled Adverse Environment™
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Contact Lens Complication
Lead sponsor: ORA, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the comfort of three commercially available contact lenses.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years old
* Have provided written informed consent
* Have discomfort when wearing contact lenses

Exclusion Criteria:

* Have an active ocular infection or significant slit lamp findings
* Participated in any other studies in the past 30 days

Primary outcomes:
measure: Contact lens wear comfort, as assessed by subject reported symptoms in diaries.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References:
Clinical trial NCT02242500: Coronally Advanced Flap With or Without Porcine Collagen Matrix for Root Coverage
Official title: Phase IV Study of Coronally Advanced Flap With or Without Porcine Collagen Matrix for Treatment of Gingival Recession: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingival Recession
Keywords: Gingival recession/surgery
Collagen/therapeutic use
Root coverage
Treatment outcome
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2014-09-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 the clinical outcomes after coronally advanced flap technique (CAF) associated or not to a porcine collagen matrix graft (CM) in the treatment of single gingival recessions. For this blinded randomized controlled clinical trial, 40 patients with Miller Class I or II gingival recession ≥ 2 mm in canines or premolars will selected and randomly assigned to receive either CAF or CAF+CM. The clinical parameters evaluated will be probing depth, clinical attachment level, gingival recession height, height and thickness of keratinized tissue. Clinical measurements will be taken at baseline and 45 days, 2, 3 and 6 months after surgery.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Presence of at least one Class I or II Miller gingival recession ≥ 2 mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ) and without deep non-carious cervical lesions (\< 0.5 mm): A + (Pini-Prato et al. 2010).
* Aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus.
* Full-mouth visible plaque index ≤ 20% (Ainamo \& Bay 1975).
* Full-mouth sulcus bleeding index ≤ 20% (Mühlemann \& Son 1971).

Exclusion Criteria:

* Smoking.
* Pregnancy.
* Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery).
* Use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair).
* Previous periodontal surgery in the area.

Primary outcomes:
measure: Recession Reduction
timeFrame: 6 months
Secondary outcomes:
measure: Complete root coverage
timeFrame: 6 months
Other outcomes:
measure: Keratinized tissue thickness
timeFrame: 6 months
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School, State University of Campinas
state: São Paulo
Study officials:
References:
Clinical trial NCT01943500: Collection of Blood Specimens for Circulating Tumor Cell Analysis
Official title: Collection of Blood Specimens for Circulating Tumor Cell Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Prostate Cancer
Colorectal Cancer
Keywords: Breast cancer
Prostate cancer
Colorectal cancer
Circulating tumor cell (CTC)
Lead sponsor: Viatar LLC
Sponsor class: INDUSTRY
Collaborators: name: Commonwealth Hematology-Oncology, P.C.
First posted: 2013-09-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Confirmed patients with stage II-IV breast, prostate, or colorectal cancer, (Or) subjects with no prior history of cancer.

Brief summary: Objective: To test the sensitivity of a proprietary novel filtration device designed to capture and concentrate circulating tumor cells (CTCs).


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years of age
* Written informed consent obtained
* Confirmed diagnosis of stage 2-4 breast, prostate, or colorectal cancer, (OR) no prior history of cancer
* Stage 2-4 treatment naive, metastatic, secondary, and recurrent cancer patients
* Able to undergo blood collection prior to initiation of chemotherapy treatment, (OR) able to provide blood sample if subject is a non-cancer control subject

Exclusion Criteria:

* Patients unable to understand the research protocol and/or provide informed consent.
* Patients with known immunodeficiency, or pregnancy.

Primary outcomes:
measure: The number of circulating tumor cells (CTCs) per milliliter of whole blood. Reported unit of measure will be the number of CTCs/milliliter.
timeFrame: Analysis will be performed within 96 hours following blood sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: Lawrence
country: United States
facility: Commonwealth Hematology-Oncology, P.C.
state: Massachusetts
Study officials:
affiliation: Commonwealth Hematology-Oncology, P.C.
name: Pedro M Sanz-Altamira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01114100: The Effects of Treatment With Sertraline for Noncardiac Chest Pain
Official title: The Effects of Treatment With Sertraline for Panic Disorder and/or Depression Driven Chest Pain and/or Palpitations in a Double Blind, Care as Usual and Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Panic Attacks
Chest Pain
Depression
Keywords: chest pain
panic attacks
palpitations
depression
panic disorder
depressive disorder
non cardiac chest pain
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2010-04-30
Enrollment: 210
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: The purpose of this study is to determine whether care as usual or intervention (consisting of sertraline versus placebo), are effective in the treatment of panic disorder and/or depression driven noncardiac chest pain.

Detailed description: Noncardiac chest pain remains an important problem in clinical cardiology. Often, panic disorder and/or depression are the underlying cause. However, this is largely underdiagnosed.

There are no clear existing treatment strategies/methods for this specific patient population.

In our double blind, placebo controlled care as usual versus sertraline study, we want to investigate whether intervention is more effective as care as usual for diminishing chest pain, and also if sertraline is more effective in this specific population compared to placebo.

Eligibility criteria: Inclusion Criteria:

* chest pain without a cardiac cause
* diagnosed with panic disorder and or depression according to Diagnostic and statistical Manual (DSM) IV criteria
* Living \< 50 km from the hospital
* informed consent

Exclusion Criteria:

* other primary DSM IV diagnosis
* known sensitivity to sertraline
* using other anti-depressive agents
* not speaking dutch language
* living in a nursery home or having dementia
* other severe, acute or progressive disease, kidney or liver-function disturbances, pregnancy or breastfeeding

Primary outcomes:
measure: panic attacks
timeFrame: 24 weeks
measure: 17 items Hamilton depression (HAMD) rating scale score
timeFrame: 24 weeks
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)reduction score
timeFrame: 24 weeks
measure: Clinical Global Impression (CGI) improvement
timeFrame: 24 weeks
measure: EuroQol (EQ-5D)score
timeFrame: 24 weeks
measure: Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score
timeFrame: 24 weeks
measure: health care costs
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: Now: St Lucas and Andreas Hospital, Amsterdam, Netherlands
name: Adriaan Honig, Prof,MD,Phd
role: STUDY_CHAIR
affiliation: Maastricht University Medical Centre, Maastricht, the Netherlands
name: Petra Kuijpers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03172000: Detection of Helicobacter Pylori in Ulcerative Colitis Patients
Official title: Detection of Helicobacter Pylori in Colonic Tissue in Newly Diagnosed Ulcerative Colitis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Helicobacter pylori (H. pylori) infection is one of the most common infectious diseases in humans.

Detailed description: Several bacterial and viral agents may have a role in the aetiology of IBD. In theory, H. pylori infection could be involved in IBD by inducing alterations in gastric and/or intestinal permeability or by causing immunological derangements resulting in absorption of antigenic material and autoimmunity via various immunological pathways.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed ulcerative colitis

Exclusion Criteria:

* Other diagnosis

Primary outcomes:
measure: Number of patients with Helicobacter
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Tanta university - faculty of medicine
Study officials:
affiliation: Tanta University Faculty of Medicine
name: Loai Mansour, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta university Faculty of Medicine
name: Ferial El-kalla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University Faculty of Medicine
name: Abdelrahman Kobtan, MD
role: STUDY_DIRECTOR
affiliation: Tanta University Faculty of Medicine
name: Hanan Soliman, MD
role: STUDY_DIRECTOR
affiliation: Tanta University Faculty of Medicine
name: Sherief Abd-Elsalam, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02519400: A Genotype Stratification Study for Pharmacokinetics and Pharmacodynamics of Amitriptyline in Healthy Male Subjects
Official title: A Single Dose, Double-blind, Genotype-based Stratification Study to Explore the Pharmacokinetics and Pharmacodynamics of Amitriptyline According to CYP2D6 and CYP2C19 Polymorphisms in Healthy Korean Male Adult Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Depression
Keywords: amitriptyline
cyp2d6
cyp2c19
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A total of 24 healthy Korean male subjects will receive a single oral dose of amitriptyline, 25 mg. Subjects will be enrolled in this study based on their cytochrome P450 2D6 and cytochrome P450 2C19 genotypes, and serial blood sampling will be done for plasma concentrations of amitriptyline, nortriptyline, and their metabolites. Various pharmacodynamic markers related to the adverse event of amitriptyline will be measured serially during the study.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteer, age 19\~45 years
* The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2
* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
* Voluntarily signed the informed consent form

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
* History of relevant drug allergies or clinically significant hypersensitivity reaction.
* Smoked more than 10 cigarettes a day for past 3 months
* Not eligible due to other reasons including laboratory results

Primary outcomes:
measure: Area under curve (AUC) of Amitriptyline, 10-Hydroxy-amitriptyline, Nortriptyline, and 10-Hydroxy-nortriptyline
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hour
measure: Maximum concentration (Cmax) of Amitriptyline, 10-Hydroxy-amitriptyline, Nortriptyline, and 10-Hydroxy-nortriptyline
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Asan Medical Center, Ulsan University
name: Hyeongseok Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213200: Intravenous and Topical Analgesics for Procedural Pain in Neonates
Official title: Systemic Analgesia and Local Anaesthesia for Percutaneous Venous Catheter Placement in Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Infant, Newborn
Keywords: pain
analgesia
morphine
amethocaine
neonate
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Society of Hospital Pharmacists
First posted: 2005-09-21
Enrollment: 108
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test which type of pain medication is best for the management of pain in newborn preterm and full-term infants having a deep intravenous cannula inserted. It will compare the effectiveness of intravenous morphine alone, a local anaesthetic cream (amethocaine) alone, and both medications together. It will also determine the safety of both medications.


Eligibility criteria: Inclusion Criteria:

* preterm and full-term infants in the NICU requiring a percutaneous central venous catheter
* ventilatory support in the form of conventional ventilation, Continuous Positive Air Pressure (CPAP) or High Frequency Oscillation(HFO)

Exclusion Criteria:

* seizures
* receiving muscle relaxants
* skin disorders causing disruption of stratum corneum

Primary outcomes:
measure: - Facial grimacing, as assessed by brow bulge, at the time of the procedure, compared among groups
Secondary outcomes:
measure: heart rate at the time of procedure
measure: oxygen saturation at the time of procedure
measure: local skin reactions at the time of procedure
measure: blood pressure for 24 hours post procedure
measure: ventilatory support for 24 hours post procedure
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taddio A, Lee C, Yip A, Parvez B, McNamara PJ, Shah V. Intravenous morphine and topical tetracaine for treatment of pain in [corrected] neonates undergoing central line placement. JAMA. 2006 Feb 15;295(7):793-800. doi: 10.1001/jama.295.7.793.
Clinical trial NCT01898052: The Efficacy of Periarticular Single Drug Compared With Multimodal Drug Injection in Controlling Pain After TKA
Official title: A Comparative Study on the Efficacy of Periarticular Single Anesthetic Drug Compared With Multimodal Drug Injection in Controlling Pain After Total Knee Arthroplasty: A Double Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: pain control
periarticular injection
Total knee arthroplasty
levobupivacaine
multimodal drug injection
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
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 determine the periarticular multimodal drug injection has more efficacy for controlling pain after TKA than single anaesthetic drug injection.

Detailed description: Many studies have to determine the efficacy of periarticular multimodal drug injection or single local anaesthetic drug comparing with placebo for pain controlled in TKA. But in this study would like to determine which one of both drugs are more efficacy.

In multimodal drug injection consist of levobupivacaine, morphine, ketorolac and epinephrine while single anaesthetic drug has levobupivacaine and epinephrine.

Eligibility criteria: Inclusion Criteria:

* primary osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
* age 50-85 years old

Exclusion Criteria:

* unable to perform spinal anaesthesia
* history of drug allergies; local anaesthesia, Non-steroidal anti-inflammatory drugs, morphine, epinephrine
* cognitive function impairment
* renal impairment (creatinine clearance \< 30 mL/min)
* liver impairment, gastrointestinal bleeding

Primary outcomes:
measure: pain score
timeFrame: 48 hour after surgery
Secondary outcomes:
measure: time to request analgesic drug
timeFrame: 48 hours
Other outcomes:
measure: drug consumption
timeFrame: 48 hours
measure: knee score
timeFrame: 3 months
Locations:
city: Khlong Luang
country: Thailand
facility: department of orthopaedic surgery, Faculty of medicine, Thammasat university
state: Pathumthani
Study officials:
affiliation: orthopaedics department
name: Supakit Kanitnate, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01132352: Bioequivalence Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fed Conditions
Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's Levetiracetam Tablets, 750 mg and Keppra® 750 mg Tablets of UCB Pharma in Healthy Adult Male Volunteers Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioavailability
Crossover
Levetiracetam
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2010-05-28
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the single-dose relative bioavailability study of Levetiracetam Tablets 750 mg with Keppra® 750 mg Tablets under fed conditions.

Detailed description: This is an open-label, randomized, single-dose 2-way crossover relative bioavailability study in healthy adult male volunteers under fed conditions with a washout period of 7 days.

Eligibility criteria: Inclusion Criteria:

* Healthy adult male volunteers, 18 to 55 years of age;
* Weighing at least 60 kg and within 15% of their ideal weights (Table of "Desirable Wights of Adults", Metropolitan Life Insurance Company, 1983);
* Medically healthy subjects with clinically normal laboratory profiles and ECGs as deemed by the principal investigator;
* Voluntarily consent to participate in the study

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
* In addition, history or presence of:

  1. alcoholism or drug abuse within the past 2 years;
  2. hypersensitivity or idiosyncratic reaction to levetiracetam;
* Subjects who have been on an special diet (for whatever reason) during the 30 days prior to the first dose and throughout the study.
* Subjects who have made a donation (Standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 56 days prior to the first dose.
* Subjects who have made a plasma donation within 7 days prior to the first dose.
* Subjects who have participated in another clinical trial within 30 days prior to the first dose.
* Subjects with hemoglobin less than 12.0 g/dL.
* Subjects who have participated in another clinical trial within 30 days prior to the first dose.

Primary outcomes:
measure: Bioavailability based on Cmax and AUC parameters
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Neptune
country: United States
facility: MDS Pharma Services
state: New Jersey
Study officials:
affiliation: MDS Pharma Services
name: Magdy L Shenouda, MD
role: PRINCIPAL_INVESTIGATOR
References: