louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04503746: A Study to Evaluate the Efficacy and Safety of ALH-L1005 in Patients With Chronic Periodontitis
Official title: A Multi-center, Randomized, Double-Blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of 12-week Treatment of ALH-L1005 600 mg or 1200 mg in Patients With Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Periodontitis
Keywords: periodontitis
Lead sponsor: AngioLab, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-07
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to evaluate efficacy and safety of ALH-L1005 in patients with chronic periodontitis


Eligibility criteria: Inclusion Criteria:

* Men or women ages 18 and over, under 79 years of age
* Patients diagnosed with chronic periodontitis
* Patients with 4 teeth and over whose pocket depth is ≥ 4 mm and clinical attachment level is ≥ 3 mm
* Patients who are voluntarily participated in clinical trial

Exclusion Criteria:

* History of antibiotic therapy within the 1 month prior to study
* Those who had undergone any dental surgical or non-surgical therapy within 3 months prior to the start of the study
* Subjects who are pregnant/ lactating
* Smokers
* Patients who take Anticoagulants or Antiplatelet Agents
* With Systemic diseases that affect periodontal conditions such as: diabetes, hypertension and diseases of immune system

Primary outcomes:
measure: Change in Pocket Depth(PD)
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Change in Pocket Depth(PD)
timeFrame: baseline, 4 weeks, 8 weeks
measure: Change in Clinical Attachment Level(CAL)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in Gingival recession(GR)
timeFrame: baseline, 12 weeks
measure: Change in Bleeding on probing(BOP) score
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: AngioLab, Inc.
state: Daejeon Gwangyeogsi
Study officials:
References:
Clinical trial NCT01875146: Effects of High-intensity Interval Training in Combination With Side-alternating Whole-body Vibration
Official title: Effects of High-intensity Interval Training in Combination With Side-alternating Whole-body Vibration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigation of the training effects following 8 weeks of high-intensity interval training (HIT)in combination with side-alternating whole-body vibration compared to conventional HIT or side-alternating whole-body vibration. The adaptations are investigated on a molecular (muscle biopsy of the M. vastus lateralis) and systemic (e.g. cycling, jumping mechanography, dynamometry) level. In addition, the acute effects of the first and last training session will be investigated on a molecular (e.g. satellite cell activation, mRNA abundance) and systemic (e.g. ventilatory ga exchange, heart rate, rating of perceived exertion) level.


Eligibility criteria: Inclusion criteria: - male

* no fever / no common cold at the beginning of the study
* between 18 and 35 years of age
* non-smoker
* no known cardiovascular or orthopedic problems
* no cardiac pacemaker
* fullfills healts questionnaire's requirements

Exclusion criteria: - female

* fever / common cold at beginning of study
* age under 18 oder above 35y
* smoker
* cardiovascular or orthopedic problems
* cardiac pacemaker
* does not fullfill health questionnaire's requirements

Primary outcomes:
measure: Change from baseline in Critical Power
timeFrame: 8 weeks intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Neurology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Neurology
name: Hans H Jung, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mueller SM, Aguayo D, Zuercher M, Fleischmann O, Boutellier U, Auer M, Jung HH, Toigo M. High-intensity interval training with vibration as rest intervals attenuates fiber atrophy and prevents decreases in anaerobic performance. PLoS One. 2015 Feb 13;10(2):e0116764. doi: 10.1371/journal.pone.0116764. eCollection 2015.
Clinical trial NCT00894946: The In Vitro Fertilization - Lipiodol Uterine Bathing Effect Study
Official title: The in Vitro Fertilisation - Lipiodol Uterine Bathing Effect Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Endometriosis
In Vitro Fertilization Implantation Failure
Keywords: recurrent IVF implantation failure
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
First posted: 2009-05-07
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that Lipiodol uterine bathing improves the success rate of in vitro fertilization (IVF) for women with endometriosis or recurrent IVF implantation failure.


Eligibility criteria: Inclusion Criteria:

* 12 or more months infertility
* Age 18 to 39
* Endometriosis or recurrent IVF implantation failure
* Patent fallopian tubes

Exclusion Criteria:

* Iodine allergy
* Blocked fallopian tube or tubes

Primary outcomes:
measure: Live birth
timeFrame: 12 months post-randomization
Secondary outcomes:
measure: Clinical pregnancy
timeFrame: 3 months post-randomization
measure: Adverse events
timeFrame: 3 & 12 months post-randomization
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: University of Auckland
Study officials:
affiliation: University of Auckland, New Zealand
name: Neil Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02769546: Physician-Patient Communication and Expectations Regarding Ovarian Cancer Prognosis
Official title: Physician-Patient Communication and Expectations Regarding Ovarian Cancer Prognosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ovarian Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ovarian Cancer

Brief summary: The primary objective is to administer a cross-sectional survey to directly compare the differences patients and physicians hold regarding ovarian cancer prognosis and survival, complications arising from treatment, and counseling on advance directives, living wills, palliative care, and hospice services. Overall, the project will pinpoint opportunities for better patient physician communication regarding prognosis and end-of-life care and allow for more informed and tailored decision-making.


Eligibility criteria: Inclusion Criteria:

* women over 18 years old with biopsy-confirmed malignancy
* being actively treated or are in surveillance for epithelial ovarian cancer
* have an existing therapeutic relationship with a provider who is participating in the study.

Exclusion Criteria:

* patients enrolled in palliative or hospice care programs, patients with a second primary malignancy within the last five years (excluding non-melanoma skin cancer)
* patients who are illiterate or non-English speaking, and patients without decision-making capacity.
* There are no exclusion criteria based on age, gender, economic status or race/ethnicity

Primary outcomes:
measure: Number of completed surveys and phone interviews
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Ashley Haggerty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03271346: Intensive Trauma Treatment for Children Exposed to Parental Conflict
Official title: Intensive Trauma Treatment for Children Exposed to Parental Conflict
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Conflict, Interparental
Trauma, Psychological
Lead sponsor: Trauma Institute & Child Trauma Institute
Sponsor class: OTHER
Collaborators: name: Gratis Foundation
First posted: 2017-09-05
Enrollment: 4
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children exposed to parental conflict and contested custody

Brief summary: The purpose of this study is to track outcomes of the investigator's therapy approach with children of separation/divorce who have been exposed to parental conflict.


Eligibility criteria: Inclusion Criteria:

* child between the ages of 6 - 16
* parent concerned re child's distress and behaviors related to custody, visitation, etc.
* parent has the legal authority to obtain treatment for the child
* parent and child fluent in English

Exclusion Criteria:

* as per clinical judgment of the PI during a telephone screening (interview of the referring parent), determination that the child is unlikely to be responsive to the intensive therapy format. This would typically be due to the child having a severe intellectual impairment, major dissociative disorder, etc.

Primary outcomes:
measure: Change in CROPS following treatment
timeFrame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
measure: Change in PROPS following treatment
timeFrame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
measure: Change in SUDS following treatment
timeFrame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
measure: Change in PRS following treatment
timeFrame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Northampton
country: United States
facility: Trauma Institute & Child Trauma Institute
state: Massachusetts
Study officials:
affiliation: Trauma Institute & Child Trauma Institute
name: Ricky Greenwald, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03706846: Study of Two Fasting Procedures Before Gastroscopy: 6 Hours Versus 2 Hours for Clear Fluids
Official title: Study of Two Fasting Procedures Before Gastroscopy: 6 Hours Versus 2 Hours for Clear Fluids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Keywords: Cirrhosis
Upper digestive endoscopy
fasting
esophageal cancer
Superficial neoplastic lesions
Esophageal mucosa
Gastric mucosa
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Upper gastrointestinal endoscopy is the key examination for screening for precancerous and cancerous lesions of the esophagus and stomach. This study aims to describe the quality of the visualization of the esophageal and gastric mucosa, the safety of use of two fasting procedures before gastroscopy and the feeling of patients. The population evaluated here concerns cirrhotic patients, at high risk of developing a precancerous lesion of the upper gastrointestinal tract.

The investigator carries out a prospective, monocentric (Besançon CHRU), interventional and randomized study according to two fasting procedures before gastroscopy: 6 hours (F6 group) versus 2 hours (F2 group) for clear fluids. The primary endpoint was to describe and compare the quality of visualization of the esophageal and gastric mucosa, graded from A (good quality) to C (poor quality) according to a score. developed by Elvas et al. (Endoscopy 2017).


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years,
* Male or female
* Cirrhosis based on radiological, clinical, biological or histological criteria

Exclusion Criteria:

* Diabetes for more than 10 years;
* Under 18 years of age;
* History of inhalation
* Patients in whom the gastrointestinal anatomy has not been retained
* Subjects who were unlikely to cooperate with the study and / or in whom poor cooperation was anticipated by the investigator
* Pregnant women Patients taking drugs that may slow down gastric Emptying such as: anticholinergic drugs, phenothiazines, antidepressants History of esophageal radiotherapy Unsubstituted hypothyroidism

Primary outcomes:
measure: Score for quality of visualization of the esophageal and gastric mucosa
timeFrame: During endoscopy
Secondary outcomes:
measure: Questionnaire concerning security
timeFrame: During endoscopy
measure: Questionnaire concerning patient confort during fasting
timeFrame: The day of the endoscopy
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References:
Clinical trial NCT01752946: A Registry Study of Shuxuening Injection Used in Hospitals in China
Official title: A Registry Study of Shuxuening (a Chinese Medicine Injection) Used in Hospitals in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Disease
Intracranial Embolism
Stroke
Angina Pectoris
Vasospasm
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Beijing University of Chinese Medicine
First posted: 2012-12-19
Enrollment: 30000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: According to the 'rule of three', 30,000 cases need to be registered at least. The aim population is who using Shuxuening injection's during inpatient time from December 2012 to December.2014 in more than 30 hospitals in China.

Brief summary: The purpose of this study is get to know what and how Shuxuening injection in hospital results in adverse events or adverse drug reactions from a cohort event monitoring.

Detailed description: Ginkgo leaf is major component of Shuxuening injection. Although some western countries product similar injections and use them, Shuxuening injection also regarded as Chinese medicine injection. As a TCM injection, the most important thing is how to safety use it in practice.

In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of allergic reaction.

Calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study. Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.

According to the 'rule of three', 30,000 cases need to be registered at least. The aim population is who using Shuxuening injection's during inpatient time from December 2012 to December 2014.

Data will be collected for three departments as following:

Form A (green): demographic information ；Form B (pink): adverse drug events/reaction； Form C (white): extracted information from hospital information system and laboratory information system.

Eligibility criteria: Inclusion Criteria:

* Patients using Shuxuening injection from 2012 to 2014

Exclusion Criteria:

* none

Primary outcomes:
measure: Incidence of Shuxuening injection's ADRs and factors contributed to the occurrence of the adverse reaction
timeFrame: to assess Shuxuening's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuening will be registered every day. The registry procedure will last 2 years only for patients using Shuxuening.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yan M Xie, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04840446: Evaluation of Modified Adhesives With Dexcom G6 Sensor
Official title: Evaluation of Modified Adhesives With Dexcom G6 Sensor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Diabetes
Continuous Glucose Monitoring Systems
Lead sponsor: DexCom, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Jaeb Center for Health Research
First posted: 2021-04-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential study participants will be identified via diabetes patient website and/or virtual registry.

Brief summary: The purpose of the study is to collect and compare information on the performance of CGM adhesives in adults.


Eligibility criteria: Inclusion Criteria:

1. Age 18 or older;
2. No previously self-reported adhesive reactions to the any continuous glucose monitor (CGM);

Exclusion Criteria:

1. Extensive skin changes/diseases that preclude wearing the required number of devices (e.g., history of severe reactions from adhesive wear, extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
2. Current or anticipated use of systemic corticosteroids (oral, injectable, or intravenous)

Primary outcomes:
measure: Adhesiveness and survivability of the adhesives
timeFrame: 10-days
Secondary outcomes:
measure: Skin irritation with the adhesives
timeFrame: 10-days
measure: Occurrence of adverse events with the adhesives
timeFrame: 10-days
measure: Assess user preference or acceptance of the adhesives worn during the study
timeFrame: 10-days
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Jaeb Center for Health Research
state: Florida
Study officials:
affiliation: Jaeb Center for Health Research
name: Thomas J Mouse, BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00818246: Light Emitting Diode (LED) for the Treatment of Wrinkles
Official title: Non-ablative Light Source for the Treatment of Rhytides (Wrinkles)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Skin Aging
Photoaging of Skin
Lead sponsor: RoseLab Skin Optics Laboratory
Sponsor class: OTHER
First posted: 2009-01-07
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine whether light emitting diode (LED) therapy can improve skin appearance of human subjects with aged/photoaged skin. A reduction in rhytid depth as well as in skin surface roughness and in the degree of elastosis after LED treatments was expected.


Eligibility criteria: Inclusion Criteria:

* subjects with aged/photodamaged skin

Exclusion Criteria:

* Subjects were not allowed to participate in this study if they were taking cortisone (Prednisone), anticoagulant therapy, or any drug known to increase photosensitivity. In addition, during the 12 months preceding the study, subjects were required not to have used isotretinoin (Accutane), or applied topical steroids to the site to be treated. Moreover, previous laser or topical medication at the to-be-treated site was not permitted.

Primary outcomes:
measure: Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness).
timeFrame: Baseline and 4 weeks
measure: Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity.
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling.
timeFrame: Baseline and 4 weeks
measure: Number of Adverse Events.
timeFrame: Adverse reactions were monitored throughout the study and up to 4 weeks.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: RoseLab Skin Optics Laboratory
state: Quebec
Study officials:
References:
citation: Barolet D, Roberge CJ, Auger FA, Boucher A, Germain L. Regulation of skin collagen metabolism in vitro using a pulsed 660 nm LED light source: clinical correlation with a single-blinded study. J Invest Dermatol. 2009 Dec;129(12):2751-9. doi: 10.1038/jid.2009.186. Epub 2009 Jul 9.
Clinical trial NCT03816046: Hyperhydrosis Treatment Using Botulinum Toxin
Official title: The Quadrant vs the Six Injection Technique in Primary Focal Hyperhidrosis Using Botulinum Toxin: a Cross-over Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperhidrosis
Keywords: botulinum toxim
abobotulinum
hyperhydrosis
injection
Lead sponsor: St Joseph University, Beirut, Lebanon
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: describe two safe and reproducible techniques for the treatment of hyperhidrosis using botulinum toxin. The same patient will receive two different injection technique in each armpit and will be evaluated subjectively and objectively.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to describe two safe and reproducible techniques for the treatment of hyperhidrosis using botulinum toxin. The same patient will receive two different injection technique in each armpit and will be evaluated subjectively and objectively.

Detailed description: The abobotulinumtoxinA (ABO) will be used in all patients. The ABO will be prepared by adding 4 cc of normal saline to a 500-unit Dysport© (Ipsen Ltd, Berks, UK) vial Preinjection patient pictures will be taken showing the technique used for each armpit.

Injection technique:

1. Technique 1 The Quadrant technique: 5 vertical lines and 5 horizontal lines will be draw on the hair bearing area of the armpit amounting to 25 injection points being more concentrated on the center. Each injection consists of 5Units of abobotulinum
2. Technique 2 the six injection technique: will consist on 6 injections in the hair bearing area equally spaced with each consisting of 8units

Follow up will be done at 15 days for post injection pictures with iodine starch test A total of 15 male patients will be recruited. And the injection for each armpit in a given patient is randomized.

Eligibility criteria: Inclusion Criteria:

Consecutive 15 male patients presenting to our clinic for primary localized hyperhidrosis will be included in this study

Exclusion Criteria:

* Patient that has received a botulinum injection in the past year

Patient that had a liposuction in the armpit or laser for the hair

Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert syndrome) Patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics) Patients with sensitivity to botulinum toxin or human albumin

Primary outcomes:
measure: objective iodine startch
timeFrame: 3weeks
Secondary outcomes:
measure: subjective: patient satisfaction
timeFrame: 3 weeks
measure: subjective: pain on injection
timeFrame: day 0
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Hotel Dieu de France
Study officials:
References: