louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00409266: CT Assessment of Minimally Invasive Surgery and Computer Assisted Navigation in Total Knee Arthroplasty
Official title: CT Assessment of Minimally Invasive Surgery and Computer Assisted Navigation in Total Knee Arthropla
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: Stryker Instruments
Sponsor class: INDUSTRY
First posted: 2006-12-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The functional flexion axis of the knee can be established by computer-assisted intra-operative data, through range of motion techniques, not specific landmarks such as epicondyles.


Eligibility criteria: Inclusion Criteria:

* Males and Females over the age of 18 and equal to or less than the age of 60
* Patients scheduled for elective Total knee arthroplasty surgery
* Patients who have signed informed consent and HIPAA Authorization
* Able to speak and understand English

Exclusion Criteria:

* Patients presenting with evidence of recent trauma, active infection, chronic pain syndrome of the spine, dementia or have been diagnosed with Alzheimer's disease
* Pregnant women
* Patients that will not sign the informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Plymouth
country: United States
facility: Jordan Hospital
state: Massachusetts
Study officials:
affiliation: Jordan Hospital
name: R S Oliver, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stoeckl B, Nogler M, Krismer M, Beimel C, de la Barrera JL, Kessler O. Reliability of the transepicondylar axis as an anatomical landmark in total knee arthroplasty. J Arthroplasty. 2006 Sep;21(6):878-82. doi: 10.1016/j.arth.2005.10.020.
Clinical trial NCT01745666: Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients
Official title: Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients With KCNQ1 or KCNH2 Mutation Without Long QT Interval in Rest ECG
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Long QT Syndrome Type 1 or 2
Keywords: Long QT syndrome, stress tests
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 130
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to evaluate the best stress exam to unmask long QT in patient with KCNQ1 or KCNH2 mutation without long QT interval in rest electrocardiogram.

Detailed description: 65 patients with KCNQ1 or KCNH2 mutation presenting QTc interval \<470msec and 65 patients without KCNQ1 or KCNH2 mutation presenting QTc interval \<470msec will be included.

All patients will have the 2 tests: exercise test and epinephrine test, in one half day.

At the end of the inclusions, two experts will examine examens results without knowing in which arm (mutated or not) the patient belongs.

Eligibility criteria: Inclusion Criteria:

Patients with QTc\<470 msec, and with molecular analysis (KCNQ1 or KCNH2 genes) performed in order to include 65 patients with KCNQ1 or KCNH2 mutation and 65 patients without KCNQ1 or KCNH2 mutation (controls).

Exclusion Criteria:

* QTc interval \>470msec
* Treatment interfering with cardiac repolarisation
* Under 15 years old
* Pregnant women
* Contraindication to exercise or epinephrine tests
* Patients without social coverage

Primary outcomes:
measure: to evaluate the best stress exam (exercise test OR epinephrine test)to unmask long QT syndrome.
timeFrame: day 1
Secondary outcomes:
measure: to evaluate each test characteristics
timeFrame: Day 1
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux Universitary Hospital
city: Marseille
country: France
facility: Marseille Universitary Hospital
city: Montpellier
country: France
facility: CHU Montpellier
city: Nantes
country: France
facility: Nantes Universitary Hospital
city: Rennes
country: France
facility: Rennes Universitary Hospital
city: Rouen
country: France
facility: CHU Rouen
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Tours
Study officials:
References:
Clinical trial NCT01529866: Study of the Integration Success of an Implant System With a Novel Abutment Attachment Design in Immediate Loading Cases
Official title: A Prospective Randomized-controlled Study of the Integration Success Rate of an Implant System With a Novel Abutment Attachment in Cases Loaded Immediately
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Edentulism
Tooth Disease
Keywords: clinical study
edentulism
dental implants
Nanotite Certain Tapered implant
randomized
crestal bone level
immediate loading
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 60
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: Integration success rates measured by lack of implant mobility and crestal bone regression measurement will be higher for the experimental implant design than for the control implants.

Detailed description: In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by cumulative success rate in cases that are loaded immediately

Eligibility criteria: Inclusion Criteria:

* patients of either sex and older than 18 years of age
* patients needing at least one dental implant to treat partial edentulism
* patients physically able to tolerate surgical and restorative dental procedures
* patients agreeing to all protocol visits

Exclusion Criteria:

* patients with infection or severe inflammation at the intended treatment sites
* patients smoking greater than 10 cigarettes per day
* patients with uncontrolled diabetes mellitus
* patients with uncontrolled metabolic diseases
* patients who received radiation treatment to the head in the past 12 months
* patients needing bone grafting at the intended treatment sites
* patients known to be pregnant at screening visit
* patients with para-functional habits like bruxing and clenching

Primary outcomes:
measure: Cumulative success rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad de Chile
Study officials:
affiliation: University of Chile
name: Juan C Carvajal, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06074666: Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3
Official title: Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Lymphoblastic Leukemia, Pediatric
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-10-10
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The current study will assess the acceptability and feasibility of the CareMeds intervention with a larger sample (N = 100) across multiple sites in Buffalo, NY, and Atlanta, GA.

Detailed description: This is a pilot randomized controlled trial of the CareMeds program to assess feasibility and obtain preliminary efficacy data among families of young children (ages 3-9) with ALL. The objective of this aim is to implement our study procedures and study conditions (CareMeds vs. usual care control). We hypothesize that pilot findings will support the feasibility of the intervention and suggest important improvements in our behavioral secondary outcomes (i.e., behavioral parenting skills, medication adherence

Eligibility criteria: Inclusion Criteria:

* Parent of a child who is diagnosed and being treated for any type of acute lymphoblastic leukemia (ALL) at a study site.
* Parent has primary medication responsibility.
* Pediatric patient aged 3-9 years
* Child on therapy that includes home-based oral anti-cancer medication taken at home, such as 6-MP.
* Parent has verbal English or Spanish fluency.
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Parent of a child who is not diagnosed nor being treated for any type of acute lymphoblastic leukemia (ALL) at a study site.
* Parent does not have primary medication responsibility.
* Pediatric patient aged 3-9 years
* Pediatric patient is not on therapy that includes oral anti-cancer medication (e.g., 6-MP).
* Parent does not have verbal English or Spanish fluency.
* Parent is unwilling or unable to follow protocol requirements

Primary outcomes:
measure: Feasibility of the CareMeds 3 sessions
timeFrame: up to 3 years
Secondary outcomes:
measure: Behavioral Parenting skills
timeFrame: Weeks 1, 4 and 12.
measure: Oral Chemotherapy adherence
timeFrame: UP to week 12
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
Study officials:
affiliation: Roswell Park Comprehensive Cancer Center
name: Elizabeth Bouchard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03147066: Dezocine for Prevention of Catheter-related Bladder Discomfort
Official title: Efficacy of Dezocine for the Prevention of Catheter-related Bladder Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Catheter Related Bladder Discomfort
Keywords: Dezocine
CRBD
General anesthesia
Urinary catheter
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the efficacy of dezocine in preventing the catheter-related bladder discomfort (CRBD) in a postanesthesia care unit (PACU).

Detailed description: Thirty min before the end of the surgery, patients were randomly assigned to one of the two group to receive intravenous dezocine 0.1 mg/kg (Group D, n=48) or flurbiprofen axetil 1 mg/kg (Group F, n=48) . The CRBD was assessed at 0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. Severity of CRBD was graded as none, mild, moderate and severe.

Eligibility criteria: Inclusion Criteria:

1. Adult (\>/=18)
2. Male or female
3. Patients scheduled for abdominal surgery
4. Undergoing catheterization
5. Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2

Exclusion Criteria:

1. Patient with bladder outflow obstruction
2. Patient with overactive bladder (frequency greater than three times per night or more than eight times per 24 h)
3. Patient with multisystemic diseases (central nervous system, cardiovascular system hepatic, psychiatric, and end-stage renal diseases)
4. Patient with chemical substance abuse
5. Patient with chronic pain
6. Patient with morbid obesity
7. Patient needs for urgent intervention

Primary outcomes:
measure: Catheter related bladder discomfort symptoms
timeFrame: at 1 hour after extubatio
Secondary outcomes:
measure: Catheter related bladder discomfort symptoms
timeFrame: at 0, 1, 2, and 6 hours after extubation
measure: Severity of pain at suprapubic area
timeFrame: at 0, 1, 2, and 6 hours after extubation
measure: Sedation level
timeFrame: at 0, 1, 2, and 6 hours after extubation
measure: Incidence of treatment-emergent adverse events
timeFrame: at 0, 1, 2, and 6 hours after extubation
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Jian-jun Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01457066: Culturally Sensitive Intervention to Improve Retention in HIV Care for Latino MSM
Official title: Culturally Sensitive Intervention to Improve Retention in HIV Care for Latino MSM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2011-10-21
Enrollment: 118
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this proposal is to culturally adapt and tailor an existing, theory-based intervention, using state-of-the-art methods designed to maximize cultural sensitivity, feasibility and acceptability to HIV+ Latino MSM, and to test it in a small randomized controlled trial (n=60 intervention; n=60 control).

Detailed description: While early receipt of and adherence to antiretroviral therapy are critical for effective HIV treatment, engagement with and retention in HIV care are essential first steps. Retention in HIV care is particularly important for traditionally disadvantaged groups, such as Latino MSMs, who are over-represented in the HIV epidemic. HIV+ Latino MSM therefore urgently need interventions to improve their retention in HIV care, which may be affected by a number of culture-specific factors. The goal of this proposal is to culturally adapt and tailor an existing, theory-based intervention, using state-of-the-art methods designed to maximize cultural sensitivity, feasibility and acceptability to HIV+ Latino MSM, and to test it in a small randomized controlled trial (n=60 intervention; n=60 control). The study will be conducted among insufficiently retained HIV+ Latino MSM at AltaMed, the largest provider of HIV medical services for Latinos in Los Angeles. The proposed intervention is designed to retain participants in HIV care by addressing barriers to and facilitators of HIV care salient to Latinos, using group-based as well as one-on-one, peer-based learning approaches.

Eligibility criteria: Inclusion Criteria include: 1) being HIV+; 2) \> 18 years old; 3) male; 4) fluent in Spanish; 5) self-identify as having Latino or Hispanic ethnicity; 6) Self-identify as gay or as ever having sex with men; 7) Must have scheduled visit with AltaMed in the prior 12 months and have a) fewer than one visit in the prior four months or b) detectable viral load

Exclusion Criteria include 1) not having a scheduled visit with AltaMed in the prior 12 months and having a) more than one visit in the prior four months or b) undetectable viral load; 2) being unable to give informed consent; 3) Lack of Spanish language skills

Primary outcomes:
measure: Retention in care
timeFrame: Six month follow up
Secondary outcomes:
measure: Intermediate outcome variables
timeFrame: Six month follow up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AltaMed
state: California
Study officials:
affiliation: University of California, Los Angeles
name: William E Cunningham, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00472966: Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma
Official title: Open Label Study to Evaluate the Efficacy and Safety of Sequential Therapy With Fluocinolone Acetonide 0.01%, Hydroquinone (HQ) 4% and Tretinoin 0.05% (TriLuma® Cream) and a Series of Glycolic Acid Peels for the Treatment of Melasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Melasma
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2007-05-14
Enrollment: 20
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 determine the effectiveness and safety of sequential therapy with of Tri-Luma® Cream and a series of Glycolic Acid peels in treatment of moderate to severe melasma.

Detailed description: To determine the efficacy and safety of sequential therapy with Fluocinolone acetonide 0.01%, Hydroquinone 4% and Tretinoin 0.05%, and a series of Glycolic Acid peels in the treatment of moderate to severe melasma.

Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with moderate to severe melasma

Exclusion Criteria:

* Subjects under treatment for a dermatologic condition, which may interfere with the safe evaluation of the study combination (e.g. eczema, psoriasis, severe sun-damage, dermatitis)
* Subjects with a diagnosis of skin cancer (BCE, SCC, Melanoma) in the areas to be treated

Primary outcomes:
measure: Efficacy - Improvement in Investigator's global assessment of melasma
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety - Tolerability assessments and adverse event reporting
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Skin Care Research, Inc.
state: Florida
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03091166: Effect of Perioperative Dexmedetomidine Administration on Outcome in Cardiac Surgery Patients
Official title: The Effect of Prophylactic Dexmedetomidine Administration on the Outcome in Patients Undergoing Surgery With Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patient Outcome Assessment
Lead sponsor: Moscow Regional Research and Clinical Institute (MONIKI)
Sponsor class: OTHER_GOV
First posted: 2017-03-27
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigation of effect of perioperative Dexmedetomedine administration on mortality, length of ICU and hospital stay, delirium onset, major adverse cardiac and cerebrovascular events, acute kidney injury in cardiac surgery patients.


Eligibility criteria: Inclusion Criteria:

* Written informed agreement
* Elective surgery
* Use of CPB

Exclusion Criteria:

* Previous prolonged immobilization
* Reoperation

Primary outcomes:
measure: 30DM
timeFrame: 30 days after surgery
measure: Delirium
timeFrame: 30 days after surgery
Secondary outcomes:
measure: VIS
timeFrame: 5 days after surgery
measure: MACCE
timeFrame: 30 days after surgery
measure: Subsyndromal delirium
timeFrame: 30 days after surgery
measure: AKI
timeFrame: 7 days after surgery
measure: ICU-LOS
timeFrame: 7 days after surgery
measure: H-LOS
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
Study officials:
affiliation: Moscow Regional Clinical and Research Institute, Moscow, Russia
name: Valery Likhvantsev, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00714766: Heat Stress and Volume Administration
Official title: Heat Stress and Volume Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Heat stress reduces the central blood volume and causes orthostatic intolerance. The hypothesis is that infusion of volume may reduce effects of orthostatic stress during heat stress.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 \< 40

Exclusion Criteria:

* Abnormal medical history

Primary outcomes:
measure: Cardiac filling pressure in relation to cardiac SV
timeFrame: with varying degress of lower body negative pressures
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept of anesthesiology 2041
Study officials:
affiliation: Rigshospitalet, Denmark
name: Niels Secher, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04521465: Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye
Official title: A Multi-Center, Single Arm, Post-Market Clinical Follow-up Study to Evaluate the Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Evaporative Dry Eye Disease
Lead sponsor: Novaliq GmbH
Sponsor class: INDUSTRY
First posted: 2020-08-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with evaporative Dry Eye Disease

Brief summary: This PMCF study is carried out following successful CE marking of NovaTears® + Omega-3 and is intended to generate systematic clinical data on the safety and performance of the device when used in accordance with the intended purpose.


Eligibility criteria: Inclusion Criteria:

* Signed ICF (Informed Consent Form) and data protection form
* Patient-reported history of DED in both eyes
* Have an Ocular Surface Disease Index (OSD) score ≥ 25 at Visit 1
* Have Meibomian Gland Dysfunction (MGD) at Visit 1.
* Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

* Women who are pregnant, nursing or planning a pregnancy
* Ocular surface pathology, clinically significant slit-lamp findings, abnormal lid anatomy, active ocular allergies
* Wear of contact lenses
* Known allergy or sensitivity to the medical device or its components
* Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 60 days before Visit 1.
* Clinical site employees or immediate family members of the same

Primary outcomes:
measure: The primary objective of this study is to confirm the performance, relieving symptoms and improving signs of DED, and to evaluate safety and tolerability of topical NovaTears® + Omega-3 (0.2%) eye drops, when used in accordance with its approved labeling
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: NTO-001 Investigational Site
city: Nürnberg
country: Germany
facility: NTO-001 Investigational Site
Study officials:
affiliation: Novaliq GmbH
name: Sonja Kroesser, PhD
role: STUDY_DIRECTOR
References:
citation: Jacobi C, Angstmann-Mehr S, Lange A, Kaercher T. A Water-Free Omega-3 Fatty Acid Eye Drop Formulation for the Treatment of Evaporative Dry Eye Disease: A Prospective, Multicenter Noninterventional Study. J Ocul Pharmacol Ther. 2022 Jun;38(5):348-353. doi: 10.1089/jop.2021.0102. Epub 2022 May 4.