louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05342649: Effect of Two Methods of Soft Tissue Augmentation for Socket Closure on Soft Tissue Landmarks and Ridge Dimensions
Official title: "Effect of Two Methods of Soft Tissue Augmentation for Socket Closure on Soft Tissue Landmarks and Ridge Dimensions- Results From Software-based Analysis of Clinical Data"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recession, Gingival
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 45
Sex: ALL
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of Connective Tissue Graft and Pediculated-Connective Tissue Graft for extraction socket closure on soft tissue landmarks and ridge dimensions.

Detailed description: 45 subjects were randomized into two groups Experimental: Main treatment group P-CTG group Active Comparator: Control group CTG group.

Eligibility criteria: Inclusion Criteria:

* Based on the Extraction Defect Sounding(EDS) Classification given by Caplanis et al,

  1. Systemically healthy subjects within the age group of 20-50years
  2. with extraction defect type 2 and type 3 were included in this study

Exclusion Criteria:

1. Medically compromised patients
2. Subjects who underwent radiotherapy or chemotherapy and
3. Smokers

Primary outcomes:
measure: BL Gain
timeFrame: Baseline to 6 months
measure: Total displacement (TD)
timeFrame: Baseline to 6 months
measure: Angle of Displacement (AOD)
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: SVS Institute of Dental Sciences
state: Telangana
Study officials:
affiliation: SVS Institute of Dental Sciences
name: Bhagyasree Medisetty, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02533349: Trial of Proton Pump Inhibitor With Prokinetics or Placebo in Patients With Laryngopharyngeal Reflux Disease
Official title: Randomized Controlled Trial of Proton Pump Inhibitor With Prokinetics or Placebo in Patients With Laryngopharyngeal Reflux Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Laryngopharyngeal Reflux Disease
Keywords: laryngopharyngeal reflux disease
prokinetics
proton pump inhibitor
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on meta-analysis of prokinetics trials in laryngopharyngeal reflux disease (LPRD) (Glicksman et al. 2014), well designed study was performed in 4 articles. But, those studies had several problems including inclusion criteria, randomization methods, and placebo medication. They had similar results that prokinetics and proton pump inhibitor (PPI) had synergistic effect for management of LPRD. Therefore, the aim of study is to evaluate the efficacy of prokinetics as an additional medication to proton pump inhibitor by well designed randomized double blind case-control study.


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 65 years
* Reflux Symptom Index (RSI) \> 7 and, Reflux Finding Score (RFS) \> 13

Exclusion Criteria

* Taken proton pump inhibitor within 3months
* Taken steroid within 3months
* Pregnancy
* Breast feeding

Primary outcomes:
measure: Reflux symptom index (questionnaire)
timeFrame: 1 month after medication
measure: Reflux finding score (scoring of laryngeal stroboscopy finding score)
timeFrame: 1 month after medication
Secondary outcomes:
measure: Reflux symptom index (questionnaire)
timeFrame: 3 months after medication
measure: Reflux finding score (scoring of laryngeal stroboscopy finding score)
timeFrame: 3 months after medication
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Glicksman JT, Mick PT, Fung K, Carroll TL. Prokinetic agents and laryngopharyngeal reflux disease: Prokinetic agents and laryngopharyngeal reflux disease: a systematic review. Laryngoscope. 2014 Oct;124(10):2375-9. doi: 10.1002/lary.24738. Epub 2014 Jun 10.
Clinical trial NCT05514249: Treatment of a Single Patient With CRD-TMH-001
Official title: Treatment of a Single Patient With CRD-TMH-001
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Duchenne Muscular Dystrophy
Keywords: Duchenne
Muscular Dystrophy
CRISPR
gene-editing
Lead sponsor: Cure Rare Disease, Inc
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
First posted: 2022-08-24
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is a single patient study intended to understand the effects of a gene-editing therapeutic to treat a rare mutation of Duchenne muscular dystrophy.

Detailed description: The objective of the study is to assess the safety and preliminary efficacy of CRD-TMH-001 after intravenous administration for a period of 1 year with long-term follow-up out to 15 years.

Eligibility criteria: Inclusion Criteria:

* Completion of informed consent
* Confirmation of genetic mutation
* Confirmation of absence of elevated AAV9 NAbs

Exclusion Criteria:

- Any significant medical issue(s) (past or current) that would, in the opinion of the Principal Investigator (PI), prevent this patient from being dosed.

Primary outcomes:
measure: To assess the safety of CRD-TMH-001
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: UMass Chan Medical School
name: Brenda Wong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cure Rare Disease
name: Medical Affairs
role: STUDY_DIRECTOR
References:
Clinical trial NCT01632449: Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.
Official title: A Randomized, Single-Blind, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by Two Different Manufacturers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: bioequivalence
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2012-07-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This is an single-blind, single-center, two-period crossover, PK profile study. Each subject will be randomized to one of two treatment sequences. Both treatment sequences will be enrolled concurrently.

Detailed description: This is a study of healthy volunteers to demonstrate bioequivalence of one formulation of BG-00012 given in capsule form supplied by two different manufactures.

Eligibility criteria: Inclusion Criteria:

* Must give written and informed consent and any authorizations required by local law.
* Males and females 18 - 55 years old inclusive at time of consent.
* Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive

Exclusion Criteria:

* History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic,metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric and renal or other major disease, as determined by the Investigator.
* Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator, and any screening values for alanine aminotransferase (ALT) aspartate aminotransferase (AST) total bilirubin, or creatinine above the upper limit of normal, or an out of normal range screening value for white blood cells (WBC).
* Current enrollment in any other drug, biologic, or device study.

Primary outcomes:
measure: PK - Area under the plasma concentration curve.
timeFrame: Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours
measure: Peak plasma concentration as a measure of PK.
timeFrame: Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours
Secondary outcomes:
measure: The number of AEs in participants as a measure of safety and tolerability.
timeFrame: Participants will be followed during the study, 4 days.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
Study officials:
References:
Clinical trial NCT00596349: Women Surviving Ovarian Cancer
Official title: Quality of Life in Women Surviving Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epithelial Ovarian Cancer
Quality of Life
Survivorship
Keywords: epithelial Ovarian Cancer
Quality of Life
Survivorship
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Queens Cancer Center of Queens Hospital
First posted: 2008-01-17
Enrollment: 62
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Memorial Sloan-Kettering Cancer Center (MSKCC) clinic The Queens Cancer Center Hospital(QCC)clinic

Brief summary: The purpose of this study is to help us learn more about how women who have had or now have ovarian cancer are doing 5 years or more from their diagnosis. We want to learn about general quality of life, long-term side effects of treatment, sexual function, thinking, memory, and psychological effects (such as anxiety and depression). We will also look at how these women are being followed for ovarian cancer. We hope this study will help us better understand how women surviving ovarian cancer are doing.


Eligibility criteria: Inclusion Criteria:

* Women with invasive epithelial ovarian cancer who are disease-free and 5 to 10 years from diagnosis (for Cohort A) and have never experienced a recurrence of epithelial ovarian cancer
* Women with epithelial ovarian cancer who have had one or more relapses, but are clinically currently disease-free, 5- to 10 years from diagnosis (for Cohort B)
* Women with current evidence of epithelial ovarian cancer who are alive with disease 5 to 10 years from diagnosis (for Cohort C)
* Fluency in English
* Written informed consent

Exclusion Criteria:

* Inability to read, communicate in English
* ovarian cancer of low malignant potential (borderline tumors)

Primary outcomes:
measure: QOL, phys funct status score on FACT & ,psychol status , cognitive functioning, Brief test of Attention, sexual funct & health behaviors among ovar ca survi & among women in 2nd or > remiss & among women surv with ovar ca 5 to 10 yrs from dx.
timeFrame: conclusion of study
Secondary outcomes:
measure: Identify potential determinants of global QOL in all three ovarian cancer survivor cohorts.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
References:
Clinical trial NCT04947449: Potential Benefits of Laser Treatment on Skin Blood Flow and Sweating in Burn Survivors
Official title: Laser Therapy on Burned Skin
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Burn Injury
Keywords: laser treatment
laser therapy
skin blood flow
sweating
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals who undergo laser treatment for burn injuries

Brief summary: The purpose of this study is to examine effects of laser therapy on blood flow and sweating responses in burn-injured skin.

Detailed description: This is a longitudinal study in which the effects of laser therapy on cutaneous vascular responses and sweating of the treated areas are assessed. Specifically, burn survivors who will undergo standard of care laser therapy to treat burn-related scars will perform whole-body heating and local heating procedures prior to the initiation of laser therapy, at an intermediate point during the laser therapy regimen, and upon conclusion of the laser therapy regimen.

For this pilot investigation a placebo will not be incorporated.

Primary outcome variables will be skin blood flow and sweating responses from skin treated with laser therapy and adjacent untreated/uninjured skin.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Experience a severe burn injury that warrant laser therapy.
* Free of any significant underlying medical problems based upon a detailed medical history and physical exam

Exclusion Criteria:

* Known heart disease
* Other chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, and uncontrolled hypercholesterolemia.
* Abnormality detected on routine screening suggestive of cardiac ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram.
* Subject with a body mass index \>35 kg/m2
* Pregnant or planning to become pregnant within the subsequent 6 months.

Primary outcomes:
measure: Skin blood flow
timeFrame: Upwards to 6 months after the final laser treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT00545649: Development of Treatments Aiming at Improvement of Function in Patients With Chronic Widespread Pain
Official title: Development of Treatments Aiming at Improvement of Function in Patients With Chronic Widespread Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
chronic pain
physical
exercise
activity
education
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2007-10-17
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the effects of adding supervised exercise in supplement to an educational self-management program, and to determine which subgroups would gain effects of the treatment.

Detailed description: 164 patients with fibromyalgia and chronic widespread pain were randomized to an exercise-education group or to education-only group. The study period was 20 week. The primary outcome measures comprised the six-minute walk test and the Fibromyalgia Impact Questionnaire. Several other self-administered instruments were included.

Eligibility criteria: Inclusion Criteria:

* Women with Fibromyalgia or Chronic widespread pain, aged from 18 to 60 years.

Exclusion Criteria:

* Other somatic or psychiatric disorders, inability to understand Swedish, allergy to chlorine, ongoing treatments or plans to start other treatments during the study period

Primary outcomes:
measure: Body function (he six-minute walk test) and health status (the Fibromyalgia Impact Questionnaire)
timeFrame: 2004-2007
Secondary outcomes:
measure: Self-administered questionnaires assessing distress, stress, quality of life, physical activity, fatigue
timeFrame: 2004-2007
Other outcomes:
Locations:
city: Alingsas
country: Sweden
facility: Alingsas Primary Health Care
city: Göteborg
country: Sweden
facility: Göteborg Primary Health Care
city: Uddevalla
country: Sweden
facility: Uddevalla Primary Health Care
Study officials:
affiliation: Göteborg University, Institute of Medicine, Department of Rheumatology and Inflammation Research
name: Kaisa Mannerkorpi, Ass prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Göteborg University, Institute of Medicine, Department of Rheumtology and Inflammation Research
name: Kaisa Mannerkorpi, Ass prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01060449: Stimulus Intensity in Left Ventricular Leads
Official title: Stimulus Intensity in Left Ventricular Leads and Response to Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: cardiac resynchronization therapy
congestive heart failure
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2010-02-02
Enrollment: 60
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: Cardiac resynchronization therapy (CRT) is a device implanted to improve the function of some people's hearts. CRT involves the placement of 3 wires in the heart through a vein near the front of your left or right shoulder into three pumping chambers of the heart, the most important being the left lower chamber, left ventricle (LV).

Detailed description: The purpose of Cardiac resynchronization therapy (CRT) is to send small amounts of energy (called pacing) through the wires to both the left and right lower chambers of your heart at (or near) the same time. This helps the heart pump in a more coordinated way and send more blood to your body with each beat. How much energy is used for pacing is called the stimulus intensity. Increasing the pacing stimulus intensity of the left ventricular wire can lead to an increase in the volume of heart muscle directly stimulated. This has previously been shown to produce beneficial effects on the heart function, like strength of contraction and increased volume of blood pumped. The purpose of this study is to determine if pacing the wires in the left ventricular chamber of the heart using higher stimulus intensity improves the strength of the heart's contraction.

Eligibility criteria: Inclusion Criteria:

* Adults who fulfill approved criteria to receive a cardiac resynchronization device.

Exclusion Criteria:

-Adults who are unable to give informed consent.

Primary outcomes:
measure: Ejection Fraction
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 6 months
measure: Six minute hall walk
timeFrame: 6 months
measure: End diastolic dimension
timeFrame: 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Michael S. Lloyd, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bavikati VV, Langberg JJ, Williams BR 3rd, Kella D, Lloyd MS. Stimulus intensity in left ventricular leads and response to cardiac resynchronization therapy. J Am Heart Assoc. 2012 Oct;1(5):e000950. doi: 10.1161/JAHA.112.000950. Epub 2012 Oct 25.
Clinical trial NCT02682849: Active Clearance Technology (ACT) Registry
Official title: Prevention of Retained-Blood Outcomes With Active Clearance Technology- The ACT Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retained Blood Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The control arm consists of a cohort of matched cardiac surgery patients with data entered over the preceding 12 to 24-month period. The site will consecutively enroll a cohort of cardiac surgery patients in the treatment arm.

Brief summary: The purpose of this study is to evaluate the effectiveness of the PleuraFlow® Active Clearance Technology™ (ACT) System in the management of blood evacuation after cardiac surgery.


Eligibility criteria: Inclusion Criteria:

1. Male or Female subjects 18 years of age or older who received a PleuraFlow System following heart surgery.
2. Patient undergoing cardiac surgery via sternotomy

Exclusion Criteria:

1. Robotic surgery
2. Any access via thoracotomy
3. Any condition deemed inappropriate for inclusion by the investigators.
4. Intolerance to implantable silicone materials.

Primary outcomes:
measure: Number of interventions to Treat Retained Blood Syndrome
timeFrame: Discharge from operating room for index-surgery through hospital discharge - approximate 30 days
Secondary outcomes:
measure: Number of episodes of new on set of post operative atrial fibrillations (POAS)
timeFrame: 30 day
measure: Number of readmissions for any diagnosis of RBS or POAS re-occurrences
timeFrame: 30 day
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: John Stulak, M.D.
role: PRINCIPAL_INVESTIGATOR
References: