louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05075213: QuitBet Phase II: A Digital Social Game That Pays You to Stop Smoking
Official title: QuitBet Phase II: A Digital Social Game That Pays You to Stop Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: WayBetter, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hennepin Healthcare Research Institute
First posted: 2021-10-12
Enrollment: 246
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized controlled trial (RCT) of QuitBet, a digital contingency management program for smoking cessation. QuitBet combines social gaming elements with participant-funded financial incentives in the form of a deposit contract. QuitBet "players" deposit (called the "bet") a specified amount of their own money into the game's "pot." All "winners" who achieve the game's goal split the pot equally, such that their bet is fully refunded plus they receive extra money from the forfeited bets of players who did not meet the goal. Participants (N = 550) will be randomly assigned to QuitBet or QuitBet-NS (deposit contract only, no social elements). All participants will be offered a second game after their first game (up to 8 weeks total game duration) and will be asked to complete a survey after each game and at 1 and 4 months after the end of the second game (3 and 6 months after the start of their first game). The study will compare QuitBet vs. QuitBet-NS on smoking behavior outcomes and examine potential mediators of outcomes such as motivation, engagement, and satisfaction.


Eligibility criteria: Inclusion Criteria:

1. Sufficient English fluency to complete study procedures
2. At least 21 years of age
3. U.S. resident of any state
4. currently smokes at least 5 cigarettes per day
5. has an email address
6. has a mailing address at which they can receive packages
7. owns an Internet-connected Apple iPhone or Android smartphone that is compatible with QuitBet
8. willing to deposit $30 via PayPal or a credit card
9. willing to receive financial incentives earned during QuitBet via PayPal or in a paper check sent by mail

Primary outcomes:
measure: 7-day point prevalence abstinence from combustible tobacco use
timeFrame: 6 months follow-up from the start date of their first QuitBet game
Secondary outcomes:
measure: proportion of participants who choose to play a second game
timeFrame: 4 weeks after the start date of their first QuitBet game (end of game)
measure: smoking heaviness
timeFrame: 6 months follow-up from the start of their first QuitBet game
measure: proportion of participants who use smoking cessation medication
timeFrame: 6 months follow-up from the start of their first QuitBet game
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: WayBetter
state: Delaware
Study officials:
affiliation: WayBetter, Inc.
name: Jamie Rosen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02483013: Clinical Study of the Whitening Dentifrices on Tooth Color and Sensitivity
Official title: Clinical, Controlled, Double-blind Study on the Effect of Whitening Dentifrices on Tooth Color and Tooth Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dentin Hypersensitivity
Keywords: whitening dentifrices
color alteration
tooth sensitivity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Objective:The aim of this clinical study was to evaluate tooth color alteration (ΔE) and tooth sensitivity (TS) in patients that used two commercial brand-whitening dentifrices for four weeks. Sixty participants were selected in accordance with inclusion and exclusion criteria and randomly allocated in three groups (n=20): G1-Colgate Luminous White®, G2- Close up White Now® and G3- Sorriso® dentifrice (placebo). Then, participants received the instructions to use only the blinded supplied dentifrice and toothbrush to make the habitual oral hygiene, three times per day during four weeks. Evaluators assessed tooth color (CIEL\*a\*b system) and TS (VAS scale) at baseline and every week (assessment points 1, 2, 3 and 4). Two-way ANOVA and posterior Tukey and Friedman test analyzed data (α = 0.05).


Eligibility criteria: Inclusion Criteria:

* At least six anterior teeth without restorations
* Participants should have good general and oral health (no dental caries and periodontal disease)

Exclusion Criteria:

* Tooth sensitivity
* Any condition that could cause tooth sensitivity (non-carious cervical lesions, dentin exposure)
* Participants following orthodontic treatment
* Smokers

Primary outcomes:
measure: Tooth color
timeFrame: 4 weeks
measure: Tooth sensitivity
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of Sao Paulo, Ribeirao Preto Campus
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo Ribeirão Preto Campus
name: Camila Tirapeli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04525313: The Prediction Model of Avastin Plus Chemotherapy in Unresectable Ras Mutant CRLM Patients
Official title: The Prediction Model of Avastin Plus Chemotherapy as First Line Treatment in Unresectable Ras Mutant Colorectal Liver Metastase (CRLM) Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Liver Metastases
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Simultaneous unresectable CRLM patients(ras mutation) with primary tumor resection before Avastin plus chemotherapy as first line treatment

Brief summary: establishment and validation of the prediction model of avastin plus chemotherapy as first line treatment in simultaneous ras mutant unresectable CRLM patients

Detailed description: Ras mutant unresectable CRLM patients with primary tumor resection followed by avastin in combination with chemotherapy were included in this study. The tumor response was assessed by local MDT group. Based on tumor response, 58 CRLM patients were classified into two groups (CR+PR vs SD+PD). Primary samples of the two group patients will be sequenced by mass spectrum. After MS sequencing, a prediction model will be estimated. Another 58 CRLM patients will be inclued for validation of the prediction model.

Eligibility criteria: Inclusion Criteria:

age 18-75 years, histologically proven colorectal adenocarcinoma, with liver-dominant disease, a life expectancy of \> 3 months, ras mutation, unresectable simultaneous liver metastasis, ECOG 0-1, written informed consent for participation in the trial.

Exclusion Criteria:

patients with known hypersensitivity reactions to any of the components of the study treatments, pregnancy or breast-feeding, accepted chemotherapy, radiotherapy and target therapy before primary tumor resection, other previous malignancy within 5 years, known drug abuse/alcohol abuse, ECOG\>1, legal incapacity or limited legal capacity.

Primary outcomes:
measure: response rate
timeFrame: 6 months
Secondary outcomes:
measure: overall survival
timeFrame: 3 years
measure: progression free survival
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00690313: Dosage Study for Vigamox Eye Drops Prior to Intravitreal Injections
Official title: To Compare the Efficacy of Topical Vigamox Eye Drops at Tid 3 Days Prior to Intravitreal Injection Versus Tid 1 Day Prior to Intravitreal Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intravitreal Injection Patients
Keywords: Vigamox, topical antibiotics, Intravitreal injections, macular degeneration, endophthalmitis
Lead sponsor: Illinois Retina Associates
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2008-06-04
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Antibiotic eye drops are being used before and after intravitreal injections. Currently there is no study indicating the benefit of there usage or their dosage.

In this study we compare the efficacy of Vigamox eye drops (antibiotic)starting 3 days prior to the injection versus 1 day prior to intravitreal injection.


Eligibility criteria: Inclusion Criteria:

* Patient who need intravitreal injections patients who are willing to participate in the study

Exclusion Criteria:

* Patients who are allergic to Vigamox or who have taken any eye drops within the past 3 weeks

Primary outcomes:
measure: Timed study
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Harvey
country: United States
facility: Illinois Retina Associates
state: Illinois
Study officials:
affiliation: Illinois Retina Associates SC
name: Kourous A Rezaei, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03638713: Comparison of Procedural Sequences in Same-day Painless Bidirectional Endoscopy With Colonoscopic Water Exchange Method
Official title: Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Disease
Bidirectional Endoscopy
Keywords: water exchange
colonoscopy
cecal insertion time
bidirectional endoscopy
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 200
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: A total of 200 patients were allocated into one of two groups by computerized randomization. Patients in the group A (colonoscopy first group) received colonoscopy followed by EGD and those in the group B (EGD first group) received EGD followed by colonoscopy.
Primary purpose: DIAGNOSTIC

Brief summary: This prospective randomized controlled trial is to compare evaluate the optimal procedure sequence among patients undergoing water exchange colonoscopy.

Detailed description: Same-day esophagogastroduodenoscopy (EGD) and colonoscopy (bidirectional endoscopy; BDE) are commonly performed to evaluate for gastrointestinal conditions, such as active gastrointestinal bleeding, iron deficiency anemia, positive fecal occult blood tests and abdominal pain. EGD-colonoscopy sequence seems to be the reasonable choice for BDE using air or CO2. With the use of water exchange method, endoscopists have to remove the dirty fecal material and air bubble during insertion. Gas insufflated during EGD may get into the colon and make subsequent water exchange colonoscopy more difficult. The aim of this prospective randomized controlled trial is to compare evaluate the optimal procedure sequence among patients undergoing water exchange colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Patients underwent fully sedated bidirectional endoscopy in the physical check-up department

Exclusion Criteria:

* Patients who \< 18 years old, \> 80 years old
* Without standard colon preparation
* Allergy to meperidine or propofol
* With a history of partial colectomy
* Refusal to provide written informed consent
* American Society of Anesthesiology (ASA) risk Class 3 or higher

Primary outcomes:
measure: cecal insertion time
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study officials:
affiliation: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
name: Yu-Hsi Hsieh, MD
role: STUDY_DIRECTOR
References:
citation: Hsieh YH, Koo M, Tseng CW. Comparison of Procedural Sequences in Sedated Same-Day Bidirectional Endoscopy with Water-Exchange Colonoscopy: A Randomized Controlled Trial. J Clin Med. 2022 Mar 2;11(5):1365. doi: 10.3390/jcm11051365.
Clinical trial NCT04475913: Digital vs Analog Impression in Cases of All-on-4 - Prosthesis
Official title: In a Post -Covid-19 World, What is the Clinical Influence of Digital vs Analog Impression in Cases of All-on-4 - Prosthesis ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Mouth
Keywords: impressions
analogue
digital
All-on-Four
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 56
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fifty six patients were randomly enrolled in the study. Participants were randomly stratified into two control groups and two test groups, from which conventional pick up and digital impressions were made respectively. Patients of group 1 (CIG Axial) and 3 (DIG Axial) received 4 axial implants whereas, group 2 patients (CIG Tilted), and group 4 (DIG Tilted) received two anterior axial implants and two distal tilted implants.

All participants received hybrid dentures. Bone loss, implant loss, maintenance of prosthesis were evaluated at 6m,12m, and 24 months follow up period.


Eligibility criteria: Inclusion Criteria:

* completely edentulous patients with age range from 50-65 years.
* physically and psychologically eligible participants for implants placement.
* adequate bone to receive 4 interforaminal implants.

Exclusion Criteria:

participants were excluded if

* medical conditions that precludes implants placement
* smokers
* patients suffering from any parafunctional habits

Primary outcomes:
measure: implant loss
timeFrame: 24 months
Secondary outcomes:
measure: crestal bone loss
timeFrame: 24 months
Other outcomes:
measure: maintenance
timeFrame: 24 months
Locations:
city: Giza
country: Egypt
facility: OctoberUMSA
Study officials:
affiliation: Lecturer
name: Dina Elawady
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04569513: The Analysis of Thyroidectomy and Parathyroidectomy
Official title: The Analysis of Thyroidectomy and Parathyroidectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Diseases
Parathyroid Diseases
Keywords: surgery
ablation
minimal invasive surgery
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 12000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of thyroid or parathyroid disorder at National Taiwan University Hospital (NTUH).

Brief summary: To analyze surgery or not, different surgical methods, timing of surgery, and alternative managements for patients of thyroid or parathyroid disease.

Detailed description: Utilizing our institutional database, tissue bank, and electronic medical charts to surgery or not, different surgical methods, timing of surgery, and alternative managements for patients of thyroid or parathyroid disease.

Eligibility criteria: Inclusion Criteria:

* age more than 20 years
* thyroid or parathyroid disorder
* willing to receive management at National Taiwan University Hospital (NTUH)

Exclusion Criteria:

* age less than 20 years

Primary outcomes:
measure: Survival
timeFrame: 1 month
measure: Progression
timeFrame: 1 month
Secondary outcomes:
measure: Tumor growth
timeFrame: 1 cm/month
measure: Life quality
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Ting-Chun Kuo
Study officials:
affiliation: Department of Surgery, National Taiwan University Hospital
name: Ming-Hsun Wu, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02564913: Integrated Clinical Evaluation of Traditional Chinese Medicine (TCM) and Conventional Medicine on Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: tongue diagnosis
heart rate variability
nailfold videocapillaroscopy
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators recruited the control group , the pre-DM group, and the DM group.

Brief summary: In traditional Chinese medicine (TCM), examination of the tongue plays an important role in diagnosis. The characteristics of the tongue(e.g., color of the tongue body, tongue fur, teeth-marked tongue) provides some clues and prognosis, which are considered a reflection of the body's internal condition. Diabetes mellitus is a metabolic disorder of hyperglycemia, which lead to damage the kidneys, eyes, nerves, blood vessels, and heart. Long standing hyperglycemia can also be associated with buccal alteration. The purpose of this study was to survey on tongue diagnosis and other examinations associated with diabetic mellitus.


Eligibility criteria: Inclusion Criteria:

* diabetic patients(ac sugar\>126mg/dl or HbA1c\>6.5, twice)
* pre-diabetic patients(100mg/dl \<ac sugar\<126mg/dl, or 5.9\<HbA1c\<6.5)
* non-diabetic patients(ac sugar\<100mg/dl )

Exclusion Criteria:

* acute infectious disease,
* cancer,
* End Stage Renal Disease

Primary outcomes:
measure: tongue diagnosis
timeFrame: 1 year
measure: heart rate variability
timeFrame: 1 year
measure: nailfold videocapillaroscopy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05109013: Juvenile Essential Arterial Hypertension and Vascular Function
Official title: Juvenile Essential Arterial Hypertension and Vascular Reactivity in Systemic and Cerebral Circulation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child, Only
Essential Hypertension
Keywords: cerebral circulation
child
endothelium
microcirculation
macrocirculation
hypertension
oxidative stress
Lead sponsor: Josip Juraj Strossmayer University of Osijek
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 50
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: children aged 9-18 years of both sexes; normotensive and children with essential arterial hypertension

Brief summary: The main goal of this study is to investigate the association of the juvenile essential arterial hypertension with systemic micro- and macrovascular reactivity and cerebral vascular function, and to examine the potential impact of elevated oxidative stress on this associations.


Eligibility criteria: Inclusion Criteria:

* healthy normotensive children and children with essential arterial hypertension

Exclusion Criteria:

* secondary arterial hypertension
* other systemic diseases with immunopathology
* neurodegenerative diseasesat
* children that use therapy which has a high impact on vascular or immunological function (immunotherapy, immunosuppressive therapy, sistemic corticosteroid therapy etc..).

Primary outcomes:
measure: Systemic microvascular function in children
timeFrame: Day 1.
measure: Systemic macrovascular function in children
timeFrame: Day 1.
measure: Cerabral vascular function in children
timeFrame: Day 1.
Secondary outcomes:
measure: Oxidative stress - thiobarbituric acid reactive substances (TBARS)
timeFrame: Day 1.
measure: Endocan
timeFrame: Day 1.
Other outcomes:
measure: Blood pressure
timeFrame: Day 1.
measure: Heart rate
timeFrame: Day 1.
measure: Body mass index
timeFrame: Day 1.
measure: Body composition - Fat Free Mass estimation
timeFrame: Day 1.
measure: Body composition - Fat estimation
timeFrame: Day 1.
measure: Body fluid status
timeFrame: Day 1.
Locations:
city: Osijek
country: Croatia
facility: Osijek University Hospital
Study officials:
affiliation: Osijek University Hospital
name: Martina Kos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00403013: Plexus Anesthesia in Lateral, Head-Down Position for Elective Surgery of the Shoulder
Official title: Axillary Plexus Block for Perioperative Analgesia in Patients Scheduled for Elective Surgery of the Shoulder: Influence of Lateral, Head-Down Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Surgery
Keywords: nerve block/*methods
Anesthetics, Local/pharmacokinetics
*Brachial Plexus
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2006-11-23
Enrollment: 64
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 whether the axillary plexus block performed in lateral, head down position is effective in the perioperative analgesia in patients scheduled for elective surgery of the shoulder.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for elective surgery of the shoulder

Exclusion Criteria:

* lateral, head down position not possible

Primary outcomes:
measure: Visual Analog Scale (VAS) score
timeFrame: 8 hours after start of axillary plexus block
measure: VAS Score
timeFrame: 24 hours after start of axillary plexus block
Secondary outcomes:
measure: Opioid consumption
timeFrame: intraoperatively
measure: Patient comfort
timeFrame: six months after surgery
measure: Opioid consumption
timeFrame: during hospital stay
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Anesthesiology and Intensive Care, University Hospital Muenster
Study officials:
affiliation: Department of Anesthesiology and Intensive Care, University Hospital Muenster
name: T Weber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orlowski O, Bullmann V, Vieth V, Filler T, Osada N, Van Aken H, Weber TP. Perivascular axillary brachial plexus block and patient positioning: the influence of a lateral, head-down position. Anaesthesia. 2006 Jun;61(6):528-34. doi: 10.1111/j.1365-2044.2006.04618.x.