louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02682329: Combination of Dental Bleaching Techniques, Randomized Clinical Trial
Official title: Combination of Dental Bleaching Techniques, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tooth Stain
Keywords: Peroxide
Lead sponsor: Universidad Iberoamericana
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effectiveness of combining different concentrations of hydrogen peroxide and carbamide used during tooth bleaching.

Detailed description: 120 patiens over 18 years old.

Design:

Hydrogen peroxide (HP) Carbamide Peroxide (CP)

Group 1: CP 10% + HP 40% Group 2: CP 15% + HP 40% Group 3: CP 20% + HP 40% Group 4: HP 10% + HP 40%

Eligibility criteria: Inclusion Criteria:

* 18 - 45 years old
* Student, teacher or administrative personnel at UNIBE.

Exclusion Criteria:

* Dental Hypersensitivity
* Periodontal disease
* Active caries lesions
* Allergy to latex
* Orthodontic treatment

Primary outcomes:
measure: Change in color after the intervention
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Feliz-Matos L, Hernandez LM, Abreu N. Dental Bleaching Techniques; Hydrogen-carbamide Peroxides and Light Sources for Activation, an Update. Mini Review Article. Open Dent J. 2015 Jan 6;8:264-8. doi: 10.2174/1874210601408010264. eCollection 2014.
Clinical trial NCT01695629: In Vivo Corneal Confocal Microscopy for Non-invasive Assessment of Diabetic Peripheral Neuropathy
Official title: In Vivo Corneal Confocal Microscopy for Non-invasive Assessment of Diabetic Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjes\\cts with diabetes with none, mild or severe neuropathy

Brief summary: Clinical in vivo confocal microscopy (IVCM) is a relatively new technique of corneal evaluation that permits non-invasive imaging of corneal structures on the cellular level. Precise anatomic characterization of corneal structures, including corneal nerves, can be rapidly performed with high resolution.

Detailed description: Evaluation of the corneal nerve layer with IVCM provides a method of direct visualization of peripheral small fiber nerves and a quantifiable assessment of nerve abnormalities in a low risk, non-invasive manner. Therefore, our goal is to develop a non-invasive diagnostic protocol as a quantitative tool for the evaluation of DPN. The protocol and the tool we seek to develop could ultimately be used in large-scale clinical trials and in clinical practice to assess DPN severity and progression.

We hypothesize that in vivo confocal imaging of the corneal nerve layer is a clinically viable method to assess and quantify systemic peripheral nerve health. We emphasize that this imaging method can be used in both humans and animal models to provide quantifiable, longitudinal data on the same live individual to advance our understanding of the development and progression of DPN, and to evaluate treatment effectiveness.

Eligibility criteria: Inclusion Criteria:

* diabetes

Exclusion Criteria:

* history of laser eye surgery, corneal disease, multiple sclerosis, Parkinson's disease, or any known systemic neuropathy.

Primary outcomes:
measure: changes between control and diabetic patients
timeFrame: 12 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Kellogg Eye Center
state: Michigan
Study officials:
References:
citation: DeMill DL, Hussain M, Pop-Busui R, Shtein RM. Ocular surface disease in patients with diabetic peripheral neuropathy. Br J Ophthalmol. 2016 Jul;100(7):924-928. doi: 10.1136/bjophthalmol-2015-307369. Epub 2015 Oct 23.
Clinical trial NCT05668429: ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects
Official title: A Phase 1, Open-Label, Single-Centre Study to Evaluate the Absorption, Distribution, Metabolism and Excretion (ADME) of Oral [14^C]-Ibrexafungerp in Healthy Male Subjects After Repeat Dosing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fungal Disease
Lead sponsor: Scynexis, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-29
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a Phase 1, open-label, single center, non-randomized study to evaluate the absorption, distribution, metabolism and excretion (ADME) of an oral solution of radiolabeled Ibrexafungerp following repeat administration in healthy male subjects. All subjects will undergo preliminary screening procedures, will remain the clinical unit for approximately 26 days and will receive radiolabeled Ibrexafungerp, orally for 3 days.


Eligibility criteria: Inclusion Criteria:

* Healthy males aged 30 to 65 years willing and able to sign and informed consent.

Exclusion Criteria:

* Clinically significant medical history or concurrent medical conditions included but not limited to infections, liver or kidney disease
* Use of certain concomitant medications
* History of smoking or alcohol abuse

Primary outcomes:
measure: Mass balance recovery
timeFrame: Day 26
measure: Metabolite identification in plasma, urine and faeces
timeFrame: Day 26
measure: Area under the plasma concentration versus time curve (AUC) of Ibrexafungerp
timeFrame: Day1 and Day 4
measure: Area under the plasma concentration versus time curve (AUC) of total radioactivity
timeFrame: Day 1 and Day 4
measure: Peak Plasma Concentration (Cmax) of Ibrexafungerp
timeFrame: Day 1 and Day 4
Secondary outcomes:
measure: Routes and rates of elimination of [14^C]-Ibrexafungerp
timeFrame: Day 26
measure: Distribution of total radioactivity into blood cells
timeFrame: Day 4
measure: Safety of Ibrexafungerp
timeFrame: Day 4
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences Limited
Study officials:
References:
Clinical trial NCT01865929: Minimally Invasive Benign Hysterectomy
Official title: Benign Hysterectomy; a Randomized Controlled Trial Comparing Robotic Hysterectomy With Vaginal Hysterectomy and Traditional Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menorrhagia
Metrorrhagia
Uterine Fibroids
Cervical Dysplasia
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 124
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods; robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy; outcome and cost analyses.

Detailed description: Laparoscopic surgery is advantageous compared to open surgery in terms of patient morbidity, shorter hospitalization and a more rapid return to daily activities. Robot-assisted laparoscopic surgery have facilitated a higher proportion of minimally invasive surgery first and foremost within gynecologic oncology.It is not clear whether or not this is true for less advanced surgery where a vaginal approach or a traditional laparoscopic approach is possible.

Robot-assisted surgery is associated with additional cost due to investment and more expensive surgical equipment. The study is performed to investigate whether or not performing hysterectomy for benign conditions with robotic surgery will be advantageous in terms of shorter operating time, less complications, less conversions to open surgery, and shorter hospital stay in comparison to other minimally invasive procedures such as vaginal hysterectomy and traditional laparoscopic hysterectomy.

Eligibility criteria: Inclusion Criteria:

* indication for hysterectomy for benign disease or prophylactic surgery due to hereditary cancer
* size of uterus and vagina allows for retrieval by the vaginal route
* maximum uterine size equivalent to 16 weeks of pregnancy
* informed consent

Exclusion Criteria:

* malignant disease
* known extensive intra-abdominal adhesions
* anaesthesiological contraindications to laparoscopic surgery
* women with pacemaker or other implants where electrosurgery is to be avoided
* immunoincompetent women
* simultaneous need for prolapse surgery
* women with known defects of the hemostasis
* allergies towards metronidazole and doxycycline
* inability to understand patient information

Primary outcomes:
measure: Cost of surgery
timeFrame: 4 months
Secondary outcomes:
measure: Patient outcome
timeFrame: 4 months
Other outcomes:
measure: Social cost
timeFrame: 4 months
Locations:
city: Lund
country: Sweden
facility: Department of Obstetrics and Gynecology, Skane University Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, Skane University Hospital, Lund
name: Jan Persson, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05793229: Frailty Trajectories and Their Association With Health Outcomes
Official title: Exploration of Frailty Trajectories and Their Association With Health Outcomes in Elderly Gastric Cancer Survivors Undergoing Radical Gastrectomy: a Prospective Longitudinal Observation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty Syndrome
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 381
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients with gastric cancer who attended a tertiary care hospital in China from March 2021 to October 2021 were selected for the study.

Brief summary: Frailty is common in gastric cancer survivors and seriously affects their prognosis. Multiple longitudinal follow-up assessment of frailty could provide a better understanding of the frailty change of individuals. Our aims were to identify the longitudinal trajectories of frailty and estimate their association with health outcomes in elderly gastric cancer survivors.

Detailed description: Our study suggested the significant heterogeneity in frailty trajectories among elderly gastric cancer survivors, and that different trajectories had different effects on health outcomes. Our results infer the necessity for prevention strategies in elderly gastric cancer survivors to manage heterogeneous frailty trajectories.

Eligibility criteria: Inclusion Criteria:

* diagnosed with gastric cancer by endoscopy or pathology;
* received radical gastrectomy the first time;
* aged ≥60 years;
* been able to communicate simply in writing and verbal;
* completed the data collection of all follow-up points.

Exclusion Criteria:

* received radiotherapy or chemotherapy before surgery;
* had other sites of malignant tumors;
* complicated with severe heart, liver, lung and renal insufficiency;
* had physical disability.

Primary outcomes:
measure: quality of life (QOL)
timeFrame: at 1-year after surgery
measure: disability
timeFrame: at 1-year after surgery
measure: 1-year hospital readmissions
timeFrame: at 1-year after surgery
measure: total costs
timeFrame: at 1-year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Xueyi Miao
state: Jiangsu
Study officials:
References:
Clinical trial NCT04718129: Testing the Effect of the Youth Mindful Awareness Program on Negative Affect
Official title: Targeting Negative Affect Through Mindfulness Training in Youth at Risk for Internalizing Problems - R61
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Keywords: Mindfulness
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: University of California, Los Angeles
name: National Institute of Mental Health (NIMH)
First posted: 2021-01-22
Enrollment: 110
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mindfulness vs. No intervention control
Primary purpose: PREVENTION

Brief summary: Randomized controlled trial comparing a coached, app-based mindfulness intervention versus a no-intervention control condition. Primary outcome: adolescents' reports of affect as measured with ecological momentary assessment (EMA) at post-intervention. Participants will include 120 youth ages 12-17 years old.

Detailed description: This is a randomized controlled trial testing a 9-session, coached, app-based mindfulness intervention on adolescents' reports of affect as measured with ecological momentary assessment (EMA). Participants will include 120 youth ages 12- to 17-years-old randomized to either the Youth Mindful Awareness Program (YMAP) or to an assessment only control condition. Participation is open to all genders and youth of all races and ethnicities.

Eligibility criteria: Inclusion Criteria:

* ages 12- to 17-years-old
* has access to a smartphone, tablet, or other mobile device on which they can access the mindfulness app and complete EMA reports. Youth without a device will be provided with one for their time in the study.

Exclusion Criteria:

* current DSM5 diagnosis of an anxiety or depressive disorder with significant clinical impairment
* current alcohol or substance use disorder; currently suicidal
* lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay
* reading level below 4th grade
* not English speaking at a level that would allow them to participate in the intervention and assessments.

Primary outcomes:
measure: Momentary Negative Affect Assessed With Ecological Momentary Assessment
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Judy Garber
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Judy Garber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05171829: An Educational Self-tracking Tool for Identification of SARS-CoV-2 Risk Transmission
Official title: An Educational Self-tracking Tool for Identification of SARS-CoV-2 Risk Transmission: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sars-CoV-2 Infection
Empowerment
Transmission
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Escoles Universitaries Gimbernat
name: University of Barcelona
name: Barcelona Institute for Global Health
name: Universitat Politècnica de Catalunya
name: Universitat Oberta de Catalunya
First posted: 2021-12-29
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: One way to empower a community, in epidemic control issues, is to know the first-hand screening tools. There are no evaluations of these home-use tools from the perspective of patient and citizen empowerment and participation. The main objective of this study is to analyze whether a self-tracking and self-tracing tool, developed in a participatory way, increases the risk identification of the disease and the empowerment in terms of risk management of transmission by the participants.


Eligibility criteria: Inclusion Criteria:

Fluent in Catalan or Spanish, Resident in Catalonia, Signs informed consent, Commitment to use the tool if he/she gets in intervention group.

Exclusion Criteria:

Language barrier and other conditions that do not allow self-completion of the survey Be a COVID case or contact at the time of recruitment.

Primary outcomes:
measure: Risk identification of SARS-CoV 2 transmission
timeFrame: 17 days
Secondary outcomes:
measure: Empowerment in SARS-CoV 2 transmission
timeFrame: 17 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
References:
Clinical trial NCT00149929: Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301
Official title: Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in de Novo Renal Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplant
Keywords: Renal Transplant, adults, immunosuppressant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of study is to collect long term safety and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of study CERL080A301 study, patients who previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert from MMF to enteric-coated mycophenolate sodium.


Eligibility criteria: Inclusion Criteria:

-First cadaveric, living unrelated or human antigen mismatched living related donor kidney transplant recipients who completed study CERL080A301

Exclusion Criteria:

* Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Incidence of biopsy proven acute rejection, graft loss, or death in the first six months of treatment.
Secondary outcomes:
measure: Incidence of biopsy proven acute rejection in the first six months of treatment in de novo renal transplant recipients.
measure: Efficacy of enteric-coated mycophenolate sodium
measure: Safety of enteric-coated mycophenolate sodium based on AE reporting.
measure: Pharmacokinetics (PK) of enteric-coated mycophenolate sodium (selected centers only).
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT05840029: VATS IN PATIENTS WITH ADVANCED OVARIAN MALIGNANCIES
Official title: THE ROLE OF VIDEO-ASSISTED THORACOSCOPIC SURGERY IN PATIENTS WITH ADVANCED OVARIAN MALIGNANCIES
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Keywords: ovarian cancer stage III, IV; VATS, CT staging
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 68
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced ovarian cancer at gyneoncology department will be enrolled

Brief summary: Ovarian cancer is the seventh most common cancer and the fifth leading cause of death in women worldwide.

About 70% of patients with epithelial ovarian cancer present with advanced disease which will require a combination of cytoreductive surgery and chemotherapy to give them their best chance of long term survival.The presence of macroscopic pleural disease-especially if undetected and unresected after primary debulking surgery-may alter treatment decision-making and markedly affect survival. Video-Assisted Thoracoscopic Surgery (VATS) allows surgeons, through a minimally invasive approach, to not only drain the pleural effusion but also evaluate macroscopic pleural disease and, when possible, resect gross tumor.

Few studies reported that VATS altered the therapeutic management in ovarian cancer patients leading to an upstaging or down-staging when compared to the CT staging. Therefore, this study will prospectively assess the role of VATS in the diagnosis and management of supradiaphragmatic disease as well as evaluate the impact of VATS findings on the decision of surgical management in patients with advanced ovarian cancer FIGO (The International Federation of Gynecology and Obstetrics) stage III/IV.


Eligibility criteria: Inclusion Criteria:

* FIGO stage III/IV ovarian cancer with or without pleural effusion

Exclusion Criteria:

1. Previously treated ovarian disease.
2. Patient unfit for single lung ventilation.
3. Patients with previous lung surgery.
4. Patients with possible intrapleural adhesions.
5. Patients who had pulmonary resection.

Primary outcomes:
measure: Prediction of intrathoracic disease using chest-CT results compared to the standard reference results using VATs
timeFrame: 3 weekS
Secondary outcomes:
measure: The rate of change in the treatment plan according to VATs results
timeFrame: 1 week
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
References:
Clinical trial NCT01297829: Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics
Official title: Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics in Patients Undergoing Laparoscopic or Open Inguinal and/or Umbilical Hernia Repair? A Randomized, Double-Blind, Prospective Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: ibuprofen
postoperative narcotics
visual analog pain scale
inguinal hernia repair
umbilical hernia repair
Lead sponsor: St. Barnabas Medical Center
Sponsor class: OTHER
Collaborators: name: Cumberland Pharmaceuticals
First posted: 2011-02-17
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Caldolor® is an intravenous (IV) formulation of ibuprofen encompassing analgesic, anti-inflammatory and antipyretic (anti-fever) properties. Caldolor® is the first IV antipyretic approved by the US Food and Drug Administration (FDA), providing an alternate route for administration of ibuprofen when the oral route is not preferable. Recent studies have reported that Caldolor® decreases morphine use and pain at rest and with movement compared to patients not receiving this drug.

The hypothesis of the proposed study is that a single dose of Caldolor® 800 mg given 30 minutes preoperatively for patients undergoing laparoscopic or open inguinal and/or umbilical hernia repair will result in a \>20% decrease in postoperative narcotic use within the first 24 hours and at 7 days, and decreased VAS Pain Score at 2 hours, 1 day, 3 days and 7 days after surgery. The use of less postoperative narcotics has been associated with a faster return of normal bowel function and resumption of normal ambulatory status thus resulting in improved general well being for the patient.


Eligibility criteria: Inclusion Criteria:

* primary inguinal and/or umbilical hernia repair
* age \> 18 years old

Exclusion Criteria:

* history of gastrointestinal bleeding
* allergy to ibuprofen
* creatinine \> 1.5 mg/dL

Primary outcomes:
measure: Postoperative Narcotic Use
timeFrame: 7 days
Secondary outcomes:
measure: Postoperative Visual Analog Pain Scale
timeFrame: 7 days
Other outcomes:
Locations:
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
Study officials:
affiliation: St. Barnabas Medical Center
name: Ronald S Chamberlain, MD, MPA, FACS
role: PRINCIPAL_INVESTIGATOR
References: