louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05729919: Healing Dynamics of Free Gingival Grafts; a Colorimetric and Volumetric Assessment
Official title: Healing Dynamics of Free Gingival Grafts; a Colorimetric and Volumetric Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Free Gingival Graft
Keywords: FGG
Volume
Color
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Gingival recession on vestibular surfaces of teeth is a frequent occurrence in patients with high standards of oral hygiene, affecting all types of teeth. During the last three decades, several surgical techniques have been proposed to treat single and multiple gingival recessions: pedicled flaps (laterally displaced (CDL) or coronally advanced (ACC) flaps), free gingival grafts (IGL), bilaminar techniques or procedures regenerative.

Detailed description: One month before surgery, an interview and periodontal therapy (pre-surgical prophylaxis, oral hygiene instructions and brushing technique teaching) will be carried out.

A digital scan of the arch with the teeth to be treated will be made before the surgery, during the surgery (recipient bed and with sutures), at 6 weeks, 3 months, 6 months and 1 year.

On the day of surgery, the recipient bed will be prepared and a free gingival graft will be taken from the palate to cover the exposed root surface or gain keratinized gingiva.

In terms of aesthetics, morbidity and satisfaction will be evaluated through questions.

At 6 weeks, 3 months, 6 months and 1year, the color of the gum will be evaluated using a spectrophotometer.

Eligibility criteria: Inclusion Criteria:

* Male or female patients between 18 and 90 years old
* Patients exhibiting deficient KT and indicated for FGG procedure (28)
* Good systemic health with absence of active periodontal disease
* Plaque and bleeding index \<20%

Exclusion Criteria:

* Uncontrolled systemic disease
* Heavy smokers (\> 10 cigarettes per day)
* Restorations that cannot be removed for proper treatment
* Pregnant or lactant women

Primary outcomes:
measure: Volumetric changes of keratinized tissue (KT) around teeth after free gingival graft (FGG).
timeFrame: 6 weeks, 3 months, 6 months, 1 year
measure: Colorimetric changes of keratinized tissue (KT) around teeth after free gingival
timeFrame: 6 weeks, 3 months, 6 months, 1 year
Secondary outcomes:
measure: Influence of the volume of an FGG on the color changes
timeFrame: 6 weeks, 3 months, 6 months, 1 year
measure: Influence of the volume of an FGG on the contraction of the keratinized gingiva
timeFrame: 6 weeks, 3 months, 6 months, 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: International University of Catalunya
Study officials:
References:
Clinical trial NCT00327119: Phase 2 Study of ABX-EGF (Panitumumab) in Japanese Subjects With M-colorectal Cancer
Official title: A Phase 2 Multicenter Single Arm Clinical Trial of ABX EGF (Panitumumab) Monotherapy in Japanese Subjects With Metastatic Colorectal Cancer Who Developed Progressive Disease or Relapsed While on or After Prior Fluoropyrimidine, Irinotecan and Oxaliplatin Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: EGFR
Fully human
Monoclonal antibody
Panitumumab
ABX-EGF
AMG954
Colorectal Cancer
Japan
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-05-18
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the effect of treatment with ABX-EGF on best overall objective response rate by modified RECIST (confirmed complete or partial response) in Japanese subjects with metastatic colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Metastatic colorectal adenocarcinoma;
* Subjects must have become refractory to treatment or unable to continue treatment due to toxicity or other reasons during or after treatment with fluoropyrimidine, irinotecan and oxaliplatin for metastatic colorectal cancer including those who relapsed during or within 6 months from the completion of adjuvant therapy using the above agents; - Tumor expressing EGFr levels by immunohistochemistry (membrane staining must be positive in 1% of evaluated tumor cells).

Exclusion Criteria:

* Subjects who have prior experimental or approved antibodies (eg, bevacizumab) within 3 months before enrollment;
* Subjects who have prior EGFr targeting agents;
* Chemotherapy other than fluoropyrimidine (including oral agents such as UFT, TS-1), irinotecan, and oxaliplatin (or raltitrexed) for colorectal carcinoma in accordance with specified regimens (leucovorin and levamisole are not considered as chemotherapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Muro K, Yoshino T, Doi T, Shirao K, Takiuchi H, Hamamoto Y, Watanabe H, Yang BB, Asahi D. A phase 2 clinical trial of panitumumab monotherapy in Japanese patients with metastatic colorectal cancer. Jpn J Clin Oncol. 2009 May;39(5):321-6. doi: 10.1093/jjco/hyp016. Epub 2009 Mar 14.
Clinical trial NCT01166919: Pilot Study on the Use of the Matrix Radiofrequencyfor Treatment of Port Wine Stain Birthmarks
Official title: Pilot Study on the Use of the Matrix Radiofrequency for Treatment of Port Wine Stain Birthmarks
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Port Wine Stain
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2010-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Port wine stain, also called nevus flammeus, is a congenital, cutaneous vascular malformation involving post-capillary venules which produces a light pink to red to dark-red-violet discoloration of the skin. It is estimated that Port wine stain occurs in 3 children per 1,000 live births. Approximately 900,000 individuals in the United States and twenty million people worldwide have Port wine stain birthmarks .

Detailed description: The purpose of this research study is to improve port wine stain treatment after Matrix Radiofrequency device treatment. The Matrix Radiofrequency device energy generates fractional deep dermal heating in the region of the electrode matrix to induce skin injury, thus eliciting a wound healing response. Less affected tissue surrounding the matrix points may be stimulated by heat which helps accelerate the healing process, while at the same time minimizing adverse effects such as scarring or changes in the normal skin pigmentation.

The researcher can determine Port wine stain areas treated with the Matrix Radiofrequency device will have improved Port wine stain blanching responses as compared to those areas treated by pulsed dye laser.

Eligibility criteria: Inclusion Criteria:

* Port Wine Stain Birthmarks suitable for comparison testing
* Age \> 18 years of age

Exclusion Criteria:

* Less than 18 years old
* Are pregnant or breastfeeding
* Other history assess by the investigator

Primary outcomes:
measure: Medical Tool
timeFrame: 8 weeks
Secondary outcomes:
measure: Port Wine Stain blanching
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: Stuart Nelson, M.D,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00481819: A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation
Official title: A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With MMF and Steroids in Patients Undergoing Kidney Transplantation and a Pharmacokinetics Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Keywords: Kidney Transplantation
Tacrolimus
Methylprednisolone
Prednisolone
Mycophenolate Mofetil
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-06-04
Enrollment: 240
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: PREVENTION

Brief summary: The patients about to undergo kidney transplantation will be randomized to one of the following two group:

Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment period is 3 months( 12 weeks)


Eligibility criteria: Inclusion Criteria:

* Written informed consent with the date of the patient must be obtained.
* Patient between 18-70 years of age receiving the primary kidney.
* Female patients must have a negative pregnancy test prior to the enrolment.
* Female patients of child bearing potential must agree to practice effective birth control during the study.

Exclusion Criteria:

* Kidney re-transplantation patients or received an organ transplantation other than a kidney.
* PRA\>10% in the previous 6 months.
* Patient who need antibody induction therapy.
* Patient with significant liver disease, defined as having continuously elevated \>2 times of SGPT and/or SGOT and/or total bilirubin levels during the past 28 days.
* Patient with severe infection requiring treatment, and/or severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption or active peptic ulcer.
* Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy.
* Patient is HIV or HBsAg positive.
* Patient is allergic to Prograf or macrolide antibiotics.

Primary outcomes:
measure: Event rate of patients with acute rejections
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of and time to acute rejections
timeFrame: 12 Weeks
measure: Overall frequency of acute rejections
timeFrame: 12 Weeks
measure: Rate of patient and graft survival following transplantation
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: 3 Sites
state: Beijing
city: Fuzhou
country: China
state: Fujian
city: Guangzhou
country: China
facility: 2 Sites
state: Guangdong
city: Wuhan
country: China
state: Hubei
city: Changsha
country: China
state: Hunan
city: Shenyang
country: China
state: Liaoning
city: Shanghai
country: China
facility: 2 Sites
state: Shanghai
city: Chongqing
country: China
state: Sichuan
city: Hangzhou
country: China
state: Zhejiang
Study officials:
affiliation: Department of Urologic Surgery
name: Prof. Ao Jianhua
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06335719: Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome
Official title: Intraoperative Brief Electrical Stimulation to Improve Cross-Face Nerve Grafting Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Facial Paralysis
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will undergo all the standard steps of the facial reanimation procedures. The difference in care is 2/3 participants may receive the brief electrical stimulation therapy.

Other 1/3 of study participants will undergo the surgery as they normally would if they had not chosen to participate.
Primary purpose: TREATMENT

Brief summary: A research study to find out if brief intraoperative electrical stimulation therapy improves nerve regeneration and smile outcomes following two-stage cross face nerve graft facial reanimation surgery.

Detailed description: Participants that choose to enroll in this study will be randomly assigned in a 2:1 ratio to a "treatment" or "control" group. In either group, patients will receive the same care as they normally would except for two minor differences. First, patients in both groups undergo nerve biopsies during surgery; these biopsies do not affect the length or outcome of surgery. Second, the treatment group will receive brief electrical stimulation therapy for approximately 10 minutes during the first stage cross-face nerve graft surgery.

The purpose of this study is to evaluate efficacy of an intraoperative dose of brief electrical stimulation (BES) to improve axonal regeneration across a cross-face nerve graft (CFNG) using nerve histology and to evaluate clinical outcomes of treatment and control groups using clinician graded, patient reported, and objective smile metric.

Eligibility criteria: Inclusion Criteria:

1. Patients 18-80 years-old with unilateral facial paralysis who are candidates for two- stage CFNG smile reanimation surgery (i.e. CFNG-driven free gracilis muscle transfer (FGMT) or dual innervation FGMT).
2. Agree to participate in the study.

Exclusion Criteria:

1. Bilateral facial paralysis
2. Age less than 18 years-old or older than 80 years-old
3. Comorbid medical condition preventing two-stage CFNG surgery

Primary outcomes:
measure: To evaluate efficacy of an intraoperative dose of brief electrical stimulation (BES) to improve axonal regeneration across a cross-face nerve graft (CFNG) using nerve histology.
timeFrame: 24 months
Secondary outcomes:
measure: To evaluate clinical outcomes of treatment and control groups using patient reported, and IRB approved CCF Facial Nerve Survey.
timeFrame: 24 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Patrick Byrne, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01575119: Decision Aid for Cigarette Smokers Undergoing Surgery
Official title: Decision Aid Development for Cigarette Smokers Undergoing Surgery: Specific Aim 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tobacco Abuse
Keywords: Cigarette smoker
Elective surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-04-11
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Smokers have three choices when faced with surgery: keep smoking, quit for a short time around surgery or quit for good. In the first specific aim, a decision aid was designed to help facilitate the discussion of these choices between smokers and healthcare providers. This second aim will test whether this decision aid improves the decisional quality compared with standard methods used to discuss perioperative smoking.


Eligibility criteria: Inclusion Criteria:

* Current cigarette smoker
* Scheduled to undergo elective surgery at Mayo Clinic Rochester
* Age 18 years or older
* Able to fully participate in all study aspects

Exclusion Criteria:

* Unavailable for telephone follow-up

Primary outcomes:
measure: Measures of decisional quality
timeFrame: Assessed immediately after the time of the preoperative conversation in the preoperative clinic
Secondary outcomes:
measure: Measures of intent and self-efficacy
timeFrame: Immediately after the preoperative evaluation in the preoperative clinic
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Warner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06568341: Turkish Validity-Reliability of the Outcome Expectations For Yoga Scale
Official title: Turkish Validity and Reliability of the Outcome Expectations For Yoga Scale
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adults
Keywords: yoga
outcome expectations
psychometric
validation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults aged 18 years and older

Brief summary: Evaluation of the Turkish validity and reliability of the outcome Expectations for Yoga (OEY) Scale, which was developed to evaluate attitudes and beliefs related to yoga practice

Detailed description: The Turkish version of the Outcome Expectations for Yoga (OEY) scale will be studied. The OEY scale is designed to assess the physical, mental, and spiritual health benefits associated with yoga practice in adults.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years and older

Exclusion Criteria:

* Pregnant women
* Body Mass Index above 40
* Practiced yoga, Tai Chi, Qi Gong, or a mindfulness-based therapy program 2 times or more in the past month or 10 times in the past year

Primary outcomes:
measure: The Outcome Expectations for Yoga (OEY) Scale
timeFrame: 6 months
Secondary outcomes:
measure: Five Facet Mindfulness Questionnaire Short Form
timeFrame: 6 months
measure: Exercise Self Efficacy Scale
timeFrame: 6 months
measure: International Physical Activity Questionnaire-Short Form
timeFrame: 6 months
measure: Short Form-12 Health Survey
timeFrame: 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Physical Therapy and Rehabilitation
state: Altindag
city: Çankırı
country: Turkey
facility: Çankiri Karatekin University
Study officials:
affiliation: Hacettepe University
name: Ozlem Ulger, Prof
role: STUDY_DIRECTOR
References:
citation: Thind H, Sillice MA, Fava JL, Lantini R, Horowitz S, Jennings E, Rosen RK, Carmody J, Becker BM, Marcus BH, Bock BC. Development and Validation of the Outcome Expectations for Yoga Scale. Am J Health Behav. 2017 Nov 1;41(6):796-802. doi: 10.5993/AJHB.41.6.13.
citation: Resnick B, Zimmerman SI, Orwig D, Furstenberg AL, Magaziner J. Outcome expectations for exercise scale: utility and psychometrics. J Gerontol B Psychol Sci Soc Sci. 2000 Nov;55(6):S352-6. doi: 10.1093/geronb/55.6.s352.
citation: Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
Clinical trial NCT00561041: Aftercare for Adolescents Treated for Alcohol Abuse and Dependence
Official title: Maintenance of Treatment Gains in Adolescents With Alcohol Related Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Use Disorder
Keywords: alcohol
alcohol use disorder
cognitive-behavioral therapy
brief phone aftercare intervention
individual aftercare therapy
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
First posted: 2007-11-20
Enrollment: 177
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The study examines the relative efficacy of two active aftercare interventions (i.e., face-to-face , brief phone) with no-active aftercare for adolescents who completed outpatient treatment for alcohol use disorders(AUD)

Detailed description: In this study 177 adolescents meeting criteria for alcohol use disorders (AUD) received weekly cognitive-behavioral therapy group sessions. 144 completers were randomized into the 3 individual aftercare (AR) conditions noted above. Manualized active interventions were composed of 5 sessions of integrated motivational enhancement and cognitive behavioral therapies. Outcomes assessments were done at end of aftercare, 3-6-and 12 months post AC completion.

Eligibility criteria: Inclusion Criteria:

* Adolescents between the ages of 13-18 years
* Meeting criteria for DSM-IV alcohol use disorders
* Able to comprehend and read English at the 5th grade level
* Participant and family member are willing to provide a locator information.
* Not planning to move out of state during the next 12 months

Exclusion Criteria:

* Meet any substance dependence criteria other than nicotine or cannabis
* Meet life time diagnosis of schizophrenia
* Reported a suicidal ideation with a plan, suicidal attempt, or self-injurious behavior in the last 30 days
* Having a medical condition that may prevent them from consistently attending and constructively participating in treatment and aftercare

Primary outcomes:
measure: Alcohol use (days of use and days of heavy drinking)
timeFrame: 3, 6, and 12 months post aftercare condition completion
Secondary outcomes:
measure: Drug use according to primary outcome timeframe
timeFrame: 3, 6, and 12 months post aftercare condition completion
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Yifrah Kaminer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00940641: Assess the Absorption, Distribution, Metabolism and Excretion of AZD7325 After Intravenous and Oral Administration
Official title: A Phase 1, Open, Two Period, Single-Centre, Study to Assess Absorption, Distribution, Metabolism and Excretion (ADME) After Intravenous and 14C-labelled Oral Administration of AZD7325 to Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Absorption
Distribution
Metabolism
Excretion
Keywords: Healthy Volunteer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-16
Enrollment: 8
Sex: MALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate the absorption, distribution, metabolism and excretion of AZD7325 after intravenous and 14C labeled oral dose


Eligibility criteria: Inclusion Criteria:

* Healthy subjects Day 1
* Body Mass Index (BMI) \> 18 and \< 30kg/m2

Exclusion Criteria:

* Clinically relevant disease and abnormalities (past or present) which in the opinion of the investigator, may either put the subject at risk to participate in this study or may influence the results of the study or the subject's ability to participate in the study
* Use of prescription medication within 14 days of the first dose of the investigational product
* Blood loss in excess of 200 mL within 30 days of Day-1 in excess of 500 mL within 90 days of Day-1 or in excess of 1350 mL within 1 year of Day-1 or donation of blood products within 14 days of Day -1

Primary outcomes:
measure: To assess absorption, distribution, metabolism and excretion of AZD7325 after IV dose and 14C oral dose administration
timeFrame: Daily
Secondary outcomes:
measure: To evaluate safety and tolerability after a single oral administration of [14C] AZD7325 and after a single intravenous administration of non radio-labelled AZD7325
timeFrame: Daily
Other outcomes:
Locations:
city: Alderley Park
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca Alderly Park CPU
name: Raj Chetty, MBBS, MD, FRCPath.
role: PRINCIPAL_INVESTIGATOR
References: