louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02216851: Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root
Official title: A Randomized, Open Label, No-treatment Controlled, Multi-center, Efficacy and Safety Study Using Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Augmentation
Keywords: hyaluronic acid
no-treatment control
enhancement
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 132
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 the safety and efficacy of using Restylane Perlane to shape the nasal dorsum and/or nasal root in comparison with a no-treatment control group


Eligibility criteria: Inclusion Criteria:

* Chinese origin
* Subject with desire to shape the nasal dorsum and/or nasal root
* Subjects who, in the opinion of the investigator, can achieve a clinically meaningful aesthetic correction of their nose with ≤ 1 ml Restylane Perlane

Exclusion Criteria:

* Subjects with previous nasal surgery, including grafts or implants to the nose area
* Subjects requiring filler treatment around the tip of the nose or between the eyebrows (glabella region) to achieve a good aesthetic outcome
* Subjects with a history of chronic sinusitis or rhinitis
* Subjects who have previously received aesthetic treatment in the forehead, glabellar and/or nose area with a dermal filler

Primary outcomes:
measure: Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
city: Guangzhou
country: China
Study officials:
affiliation: Galderma R&D
name: Q-Med AB
role: STUDY_DIRECTOR
References:
Clinical trial NCT06201351: Study of Adaptive Radiotherapy for High-grade Glioma Based on Interfraction MRI
Official title: Study of Adaptive Radiotherapy for High-grade Glioma Based on Interfraction Magnetic Resonance Imaging (MRI)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: High-grade Glioma
Keywords: adaptive radiotherapy
high-grade glioma
MRI image
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with high-grade glioma confirmed by pathology in our hospital and treated with standard STUPP regimen.

Brief summary: The changes of target and organs at risk in patients with high-grade glioma during concurrent chemoradiotherapy were evaluated by MRI image between radiotherapy fractions.

Detailed description: To prospectively evaluate the changes of target organs and risk organs in patients with high-grade glioma during concurrent chemoradiotherapy.The related factors causing this change are discussed.The relationship between changes and patient survival was analyzed.A predictive model was established to provide individualized adaptive radiotherapy for patients.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old;
2. High-grade glioma was confirmed by pathology after surgery;
3. ECOG score 0-2 points;
4. Receiving the standard STUPP regimen (i.e. 6 weeks of temozolomide concurrent chemoradiotherapy +6 cycles of temozolomide adjuvant chemotherapy);
5. Baseline data available.

Exclusion Criteria:

1. The pathological diagnosis is not clear;
2. No synchronous chemotherapy/adjuvant chemotherapy \&amp;lt; 6 cycles;
3. There are other malignant tumors;
4. Previously radiotherapy to the head;
5. Interruption of radiotherapy for more than 5 days;
6. Failure to collect baseline data.

Primary outcomes:
measure: Homogeneity index
timeFrame: up to 2 weeks
measure: conformity index
timeFrame: up to 2 weeks
measure: Anatomic change
timeFrame: up to 2 weeks
Secondary outcomes:
measure: progression-free survival (PFS)
timeFrame: assessed up to 12 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT05886751: Randomized Trial of Trust in Online Videos About Prostate Cancer
Official title: Randomized Trial of Trust in Online Videos About Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Trust
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-06-02
Enrollment: 3649
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study team will evaluate the impact of video characteristics on health consumers' trust in online videos. Participants will be randomized to watch a video by one of four speakers about prostate cancer screening or clinical trials and complete a questionnaire (approximately 15 minutes total).


Eligibility criteria: Inclusion Criteria:

1. US adult age 40+
2. Enrolled in Dynata online survey panel

Exclusion Criteria:

1. Children
2. Individuals living outside the U.S.

Primary outcomes:
measure: Level of Trust in the Video
timeFrame: Visit 1 (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Stacy Loeb, MD, MSc, PhD(hc)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loeb S, Ravenell JE, Gomez SL, Borno HT, Siu K, Sanchez Nolasco T, Byrne N, Wilson G, Griffith DM, Crocker R, Sherman R, Washington SL 3rd, Langford AT. The Effect of Racial Concordance on Patient Trust in Online Videos About Prostate Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2324395. doi: 10.1001/jamanetworkopen.2023.24395.
Clinical trial NCT01309451: Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema
Official title: A Single Masked, Randomized Controlled Study to Assess Efficacy of Ozurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema
Keywords: diabetic macular edema
DME
Lead sponsor: Maturi, Raj K., M.D., P.C.
Sponsor class: INDIV
First posted: 2011-03-07
Enrollment: 40
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 investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.


Eligibility criteria: Inclusion Criteria:

* Male or female age 18 years or older
* Type 1 or type 2 diabetes
* BCVA score of \>24 and \<78 letters
* Presence of DME defined as Optical Coherence Tomography Center Subfield Thickness (OCT CST) \>250microns

Exclusion Criteria:

* Anti-VEGF intravitreal treatment in last 4 weeks
* Intravitreal steroid treatment in the last 8 weeks
* PRP or Focal laser in last 4 months
* Active iris neovascularization

Primary outcomes:
measure: Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline
timeFrame: baseline to 12 month
measure: OCT CST
timeFrame: change in OCT CST from baseline to twelve months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Raj K. Maturi, MD
state: Indiana
Study officials:
affiliation: Midwest Eye Institute
name: Raj K Maturi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00239551: Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer
Official title: Effect of Prevacid on Prostaglandin Levels in the Gastric Mucosa of Patients With Stress Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stomach Ulcer
Keywords: gastric stress ulcer
Prevacid
Prostaglandin
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: TAP Pharmaceutical Products Inc.
First posted: 2005-10-17
Enrollment: 30
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: The purpose of this study is to measure the prostaglandin levels in patients with stress ulcer and the effect of Prevacid on prostaglandin levels in patients with stress ulcer.

Detailed description: The prostaglandin system plays an important role in the gastric mucosa to strengthen its resistance against injury. Critically ill patients are at greatest risk of developing stress-related gastric mucosal lesions. Although the levels of prostaglandins in gastric mucosa in patients with stressed animal has been studied, prostaglandin levels in the gastric mucosa in patients with stress ulcer have not been studied and the effect of Prevacid on prostaglandin levels in gastric mucosa from patients with stress ulcer is unknown.

We hypothesize that prostaglandin levels are low in the gastric mucosa in patients with stress ulcer, and Prevacid is an effective agents in increasing prostaglandin levels in the gastric mucosa in stress stress ulcer.

Comparison(s): The prostaglandin levels in patients who treated with Prevacid for stress ulcer, compared to the prostaglandin levels in patients who treated with H2 blocker for stress ulcer.

Eligibility criteria: Inclusion Criteria:

* Patients in ICU with documented gastric stress ulcer by endoscopic examination, including patients with H. Pylori infection;
* Patients have no known ulcer within 8 weeks prior to be admitted to ICU;
* Patients not on any PPI for 4 weeks prior to the study;
* Patients or family be consented for the study.

Exclusion Criteria:

* Patients have gastric ulcer within 8 weeks prior to be admitted to ICU;
* Patients have gastric cancer confirmed by pathology;
* Patients on one of the PPIs already;
* Patients on any of the Non-steroidal Antiinflammatory Drugs.

Primary outcomes:
measure: the effect of Prevacid on prostaglandin levels at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: esophagogastroduodenal endoscopy(EGD) with biopsy at day 1; EGD with biopsy at 8 weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
Study officials:
affiliation: Emory University
name: Qiang Cai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Vincent W Yang, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01378351: Vestibular Dysfunction as a Cause of Chronic Nausea & Vomiting: A Follow up Survey
Official title: Vestibular Dysfunction as a Cause of Chronic Nausea & Vomiting: A Follow up Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dysfunction of Vestibular System
Nausea Persistent
Vomiting
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2011-06-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient gastroenterology clinic

Brief summary: The purpose of this study is to characterize the accompanying symptoms, evaluation and management of patients with chronic vestibular dysfunction presenting with nausea and vomiting.

Detailed description: Based on prior study, a significant portion of patients referred for refractory gastroparesis in fact have signs suggestive of vestibular dysfunction as the cause of chronic nausea and vomiting. Our prior retrospective study identified a population of said subjects.

The aim of this study is to further characterize the concomitant symptoms, course of diagnosis, treatment and long-term follow up (up to 5 yrs) of this condition.

Eligibility criteria: Inclusion Criteria:

* Clinical symptoms of nausea and vomiting for at least 4 weeks
* Abnormal modified Fukuda stepping test on examination (\>90 degree rotation from midline while marching in place for 60 seconds) or nystagmus or abnormal Rhomberg test

Exclusion Criteria:

* Pregnancy
* Unable to complete questionnaire survey

Primary outcomes:
measure: Improvement of nausea and vomiting
timeFrame: 1 to 2 months
Secondary outcomes:
measure: Associated symptoms
timeFrame: 1 to 2 months
measure: Alternate diagnoses
timeFrame: 1 to 2 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Lawrence Schiller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01533051: Prospective Observational Cohort Study for the Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B
Official title: Phase IV Study of Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
Keywords: Chronic hepatitis B
Nucleos(t)ide analogue
Antiviral treatment
Korea
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic Hepatitis B patients under anti-viral therapy

Brief summary: The aim of this study is to investigate the off-treatment sustained virological and biochemical response in chronic hepatitis B patients following the guideline by the Asian Pacific Association for the Study of the Liver (APASL) in Korea.

Detailed description: In the recommendation by the Asian PAcific Association for the Study of the Liver(APASL), antiviral drug is recommended to stop when HBeAg seroconversion has developed for more than 6 months among HBeAg-positive patietns. For HBeAg-negative patients, the APASL consensus recommended stopping anti-viral treatment when HBV DNA remained undetectable for three separates occasion 6 months apart. Nontheless, approximately 25% to 50% of the patients still develop hepatitis relapse after stopping anti-viral therapy even if these recommendations are followed. In this study, the investigators aimed to investigated the off-treatment sustained response in chronic hepatitis B parients following the stopping anti-viral treatment guideline in Korea.

Eligibility criteria: Inclusion Criteria:

* More than 20 years old
* Chronic hepatitis B patients under anti-viral therapy

  1. In HBeAg-positive patient; if HBeAg seroconversion with undetectable HBV DNA is documented on two separate occasions at least 6 months
  2. In HBeAg-negative patient; if undetectable HBV DNA has been documented on three separate occasions 6 months apart

Exclusion Criteria:

* Patients who had chronic liver disease due to hemochromatosis, autoimmune hepatitis, drug-induced hepatitis, or thalassemia
* Patients who suffered from other chronic medical condition

Primary outcomes:
measure: Sustained virological response after stopping anti-viral treatment
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sang Hoon Ahn
Study officials:
affiliation: Department of Internal Medicine, Yonsei Universtiy College of Medicine
name: Sang Hoon Ahn, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00000351: Cognitive Correlates of Substance Abuse, Part 2 - 16
Official title: Cognitive Correlates of Substance Abuse, Part 2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amphetamine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Part II: Examine cognitive performance of stimulant abusers (methamphetamine and cocaine) during recovery by assessing their cognitive function at monthly intervals.

Detailed description: Part II: Examine cognitive performance of stimulant abusers (methamphetamine and cocaine) during recovery by assessing their cognitive function at monthly intervals.

Eligibility criteria: Please contact site for information

Inclusion Criteria:

M/F. Meet DSM-IV criteria for stimulant dependence. Agree to conditions of the study and sign informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05226351: Activation of the Endocannabinoid System and Cognition
Official title: Activation of the Endocannabinoid System and Cognition (Effekte Einer Akuten Aktivierung Des Cannabinoid-Systems Auf Kognitive Funktionen)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD). Low endocannabinoid signaling has been found in PTSD patients and might even present a precondition to develop PTSD after trauma. The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid (dronabinol, i.e., delta-9-tetrahydrocannabinol) on fear conditioning.

Detailed description: Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD). Low endocannabinoid signaling has been found in PTSD patients and might even present a precondition to develop PTSD after trauma. In consequence, increased endocannabinoid signaling during acquisition and consolidation of traumatic events might be a promising approach to prevent the development of PTSD. The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid (dronabinol, i.e., delta-9-tetrahydrocannabinol) on tfear conditioning in patients with PTSD and healthy controls.

Eligibility criteria: Inclusion Criteria:

* PTSD criteria fullfilled (patients only)

Exclusion Criteria:

* All cases of physical illnesses and intake of medication (except oral contraceptives) (healthy controls only) will be excluded.
* Pregnant and lactating individuals will also be excluded. Participants with a positive urinary cannabinoid test (Cannabis 20 Pipettier-Drogenschnelltest (Urin), Diagnostik Nord GmbH) will also be excluded.
* psychiatric disorder according to DSM-5 (healthy controls only)

Primary outcomes:
measure: extinction learning
timeFrame: 30 minutes
Secondary outcomes:
measure: empathy
timeFrame: 15 minutes
measure: Probabilistic Reversal Learning Task
timeFrame: 15 minutes
measure: selective attention
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Charite University
Study officials:
References:
Clinical trial NCT05607251: Salivary Alkaline Phosphatase as a Biomarker for Dental Caries in A Group of Egyptian Children With Different Growth Rates: A Descriptive Cross-Sectional Study
Official title: Salivary Alkaline Phosphatase as a Biomarker for Dental Caries in A Group of Egyptian Children With Different Growth Rates: A Descriptive Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Caries in Children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged between 6-8 years.

Brief summary: Aim of the study:

1. Assess the correlation between salivary alkaline phosphatase levels and dental caries.
2. Assess the effect of growth of children on the levels of salivary alkaline phosphatase enzyme.
3. Assess the effect of growth of children on caries experience and severity.


Eligibility criteria: Inclusion Criteria:

* Children aged 6 to 8 years old.
* Children with and without previous dental visits.

Exclusion Criteria:

* Children with any systemic or mental illness.
* Children whose parents refuse to sign the informed consent.
* Children who will not cooperate on participation

Primary outcomes:
measure: Salivary Alkaline Phosphatase levels in children with and without dental caries
timeFrame: 2 months
Secondary outcomes:
measure: Caries index
timeFrame: 2 months
measure: Caries severity
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References: