louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03973242: Dual-focus Magnification With Narrow-band Imaging in Helicobacter Pylori Infection
Official title: Usefulness of Dual-focus Magnification With Narrow-band Imaging in the Prediction of Helicobacter Pylori Infection: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori Infection
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 292
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study group: Dual Focus with Narrow band imaging Control group: White light endoscopy
Primary purpose: DIAGNOSTIC

Brief summary: Dual-focus with narrow-band imaging (DF-NBI) is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. The investigators compare this technique with conventional white light (WL) endoscopy to predict Helicobacter pylori infection.

Detailed description: The subjects are patients who underwent upper gastrointestinal endoscopy under sedation. Participants are randomized into DF-NBI and WL groups. Rapid urease test will be performed in all cases. By captured images of gastric mucosa, classification of DF-NBI for Helicobacter pylori infected mucosa will be developed and validated. The established classification of WL for Helicobacter pylori infection will be used. Finally, the investigators will compare the accuracy between two groups based on each classification.

Eligibility criteria: Inclusion Criteria:

* consecutive patients who have undergone uper gastrointestinal endoscopy for diagnosis or screening of cancer.

Exclusion Criteria:

* Those whose Hp status had already been clarified
* Pregnancy
* History of partial gastrectomy
* Taking proton pump inhibitor, antithrombotics or antibiotics within 4 weeks

Primary outcomes:
measure: Accurate prediction of Helicobacter pylori status
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
References:
Clinical trial NCT02002442: Dental Implants and Mouth Rinse
Official title: Comparison of the Effect of the Preoperative Use of Chlorhexidine, Essential Oil, and Cetylpyridinium Chloride Mouthwashes on Bacterial Contamination During Dental Implant Placement: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Reduction in Bacterial Counts Through the Use of Mouthwash
Keywords: Mouthwash
Chlorhexidine
cetylpyridinium chloride
Saline
Implants
Saliva Collection
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary aim of this study is to evaluate and compare the efficacy of a 60 second rinse with chlorhexidine, essential oil-based mouthwash, cetylpyridinium chloride mouthwash, or saline solution on bacterial contamination in the buccal vestibule when used preoperatively using the real-time Polymerase Chain Reaction (qPCR).

We hypothesize that preoperative rinse with chlorhexidine mouthwash will result in greater reduction of bacterial counts than with essential oil-based, cetylpyridinium chloride, or saline mouthwashes.

The secondary aim of this study is to evaluate the effect of the tested mouthwashes in reducing the bacterial counts over time.

We hypothesize that preoperative rinse with chlorhexidine mouthwash will result in a reduction of bacterial counts for longer duration than with essential oil-based, cetylpyridinium chloride, or saline mouthwashes.


Eligibility criteria: Inclusion Criteria:

* Patient who is treatment planned for dental implant placement and qualifies for dental implant placement according to the standards of care in the Department of Periodontology at Tufts University School of Dental Medicine.
* Aged 18 years and above.
* Partially edentulous.

Exclusion Criteria:

* Antibiotic therapy within 2 weeks of the study.
* Active infection in the oral cavity.
* Known allergy to any of the agents used in the study.
* Self-reported pregnancy (as the surgical procedure of dental implant placement is elective and typically deferred until after the delivery).
* Fully edentulous.
* Patient with severe periodontitis (Clinical attachment loss of 5mm or more in the majority of intraoral sites).
* Regular use of mouthwashes (once/day).

Primary outcomes:
measure: Oral Rinse Comparison
timeFrame: 60 seconds rinse
Secondary outcomes:
measure: Bacterial Count Reduction
timeFrame: 60 seconds rinse
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Dental Medicine Department of Periodontology
state: Massachusetts
Study officials:
References:
Clinical trial NCT01011842: Real-Time kV Imaging vs. Real-Time 3D Patient Surface Tracking for Head & Neck Cancer
Official title: Comparison of Intrafraction Motion in Patients With Head and Neck Cancer Using Real-Time kV Imaging vs. Real-Time 3D Patient Surface Tracking
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2009-11-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To determine if a new optical system that can track a patient's movement during treatment can be used to measure motion and allow for motion adjustments in order to decrease the amount of healthy tissue that receives radiation without limiting our ability to cure cancers using radiation.


Eligibility criteria: Inclusion Criteria:

* Patients with HNC undergoing radiation therapy at Stanford University
* Age \>= 18 years old
* Radiation course \>= 4 weeks duration
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Factors such as claustrophobia inhibiting use of thermoplastic mask immobilization device.
* Patients who are pregnant or nursing, which preclude them from undergoing active radiation treatment.

Primary outcomes:
measure: We are measuring how much a patient moves during treatment.
timeFrame: This information will be available immediately have the patient is treated.
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Quynh-Thu Le
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01455142: A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
Official title: A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-10-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
* Body mass index from 18.0 to 28.0 kg/m\^2 (both inclusive)
* HbA1c below or equal to 9.5% by central laboratory analysis

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the serum insulin degludec concentration-time curve
timeFrame: From 0 to 120 hours after single-dose (SD)
measure: Maximum observed serum insulin degludec concentration
timeFrame: After single-dose (within 0 to 120 hours after dosing)
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: From 0 to 12 hours after single-dose
measure: Maximum observed serum insulin aspart concentration
timeFrame: After single-dose (within 0 to 12 hours after dosing)
Secondary outcomes:
measure: Area under the glucose infusion rate curve
timeFrame: From 0 to 26 hours after single-dose
measure: Maximum glucose infusion rate
timeFrame: After single-dose (within 0 to 120 hours after dosing)
Other outcomes:
Locations:
city: Graz
country: Austria
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00944242: Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Torrent Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2009-07-23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: * Objective:

  * To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertraline, administered as a 1X100 mg tablet, under fasted conditions.
* Study Design:

  * Single-dose, open-label, randomized two-way crossover.


Eligibility criteria: * Inclusion Criteria:

  * Male or female, smoker or non smoker, 18 years of age and older.
  * Capable of consent.
  * BMI\>= 19.0 and \<30.0 kg/m2
* Exclusion Criteria:

Subjects to whom any of the following applies will be excluded from the study:

* Clinically significant illness or surgery within 4 weeks prior to the administration of the study medication.
* Positive testing for hepatitis B, hepatitis C, or HIV at screening.
* ECG abnormalities or vital sign abnormalities(blood pressure).
* History of significant alcohol or drug abuse within one year prior to the screening visit.
* History or allergic reactions to heparin, sertraline or other related drugs.
* Use of an investigational drug or participation in an investigational study with in 30 days prior to administration of the study medication.
* Clinically significant history of gastrointestinal pathology, liver or kidney disease, neurological, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
* History of seizures, suicide attempt, bipolar disorder or manic episodes.
* Depot injection or an implant of any drugs with in 6 months prior to administration of study medication.
* Breastfeeding subject.
* Positive urine pregnancy test at screening.
* female subject of child bearing potential having unprotected sexual intercourse with any non-sterile mail partner within 14 days prior to study drug administration.

Acceptable methods of contraception:

1. Intra-uterine contraceptive device(placed at least 4 weeks prior to study drug administration)
2. Condom or diaphragm + spermicide.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Anapharm Inc.
state: Quebec
Study officials:
References:
Clinical trial NCT05567042: A Clinical Study of Epilepsy Localization and Prognosis Based on PET and Resting-state fMRI
Official title: A Clinical Study of Epilepsy Localization and Prognosis Based on Positron Emission Tomography and Resting-state Functional Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epileptic Seizure
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Observational study of epilepsy patients treated at the Epilepsy Center of Xijing Hospital

Brief summary: 1. By following up the prognosis of surgical patients, the application value of Cortex ID quantitative analysis in the localization of epilepsy foci was studied.
2. By studying the correlation between autonomic nerve function and epilepsy neural network in epilepsy patients, and analyzing the differences between different epilepsy patients, it can provide more information for judging the prognosis of epilepsy patients.

Detailed description: This study included diagnostic trials and case-control studies, which were observational studies with no intervention. First, the demographic and clinical information of epilepsy patients in the Neurology Department of Xijing Hospital were collected, including gender, age, age of onset, course of epilepsy, seizure performance before treatment, seizure frequency before treatment, type and dose of antiepileptic drugs, past history, Family history, etc., as well as imaging, EEG, quality of life, and neuropsychological assessment, etc. were collected; secondly, functional magnetic resonance imaging (fMRI) and 24-hour Holter monitoring were performed on patients who met the inclusion criteria. Positron Emission Computed Tomography (PET) images of patients who have undergone or plan to undergo surgery are analyzed; finally, appropriate statistical methods are used for analysis.

Eligibility criteria: Inclusion Criteria:

Meet the diagnostic criteria for epilepsy,

* No contraindications for fMRI examination.
* The patient had no other heart and lung diseases except epilepsy.
* Patients and their families were aware of this study and signed informed consent.

Exclusion Criteria:

* Patients with severe infection, cerebrovascular disease, malignant tumor and other systemic diseases that can affect the nervous system, and those with serious dysfunction of the heart, liver, kidney and other organs.
* Non-epileptic seizures such as syncope and hysteria.
* Pregnant or lactating women. Incomplete clinical data

Primary outcomes:
measure: Seizure frequency
timeFrame: 2022-2024
measure: Seizure duration
timeFrame: 2022-2024
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kassinopoulos M, Harper RM, Guye M, Lemieux L, Diehl B. Altered Relationship Between Heart Rate Variability and fMRI-Based Functional Connectivity in People With Epilepsy. Front Neurol. 2021 Jun 10;12:671890. doi: 10.3389/fneur.2021.671890. eCollection 2021.
Clinical trial NCT02756442: Respiratory Disorder During Sleep in the Pregnancy : A Risk Factor in Gestational Diabetese
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Disorder in Patient With Gestational Diabetes
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Introduction:

The pregnancy brings about physiological and hormonal modifications which cause sleep disorder. The sleeplessness, snoring and a bad sleepquality are frequent during the pregnancy. Also a limited breathing airflow happens very often during the pregnancy. The limited airflow causes micro-awakenings that enter in the frame of the high resistances airways syndrome. To our knowledge there is no study about the outcome of micro-awakenings at pregnant women.

Objectives:

To compare the prevalence of the high resistances airways syndrome (RERA) in pregnant woman with or without gestational diabetes

Methods :

It is a monocentrical prospective study at pregnant women after the 30th amenorrhea week who consul the gynecologie and obstetrics department of the CHU NORD in Marseille. We are going to compare the breathing disorder during sleep of a control group with a group of women with gestational diabetes. A polysomnograph will be run at the included patients' home.

Expected results :

The physiological and hormonal modifications during the pregnancy could favor nocturnal sleep events (snoring, SAHOS and RERA) and its complications as gravidic HPN And gestational diabetes cause maternal and fœtal and morbidity and mortality. We put the hypothesis that limited airflow in association with micro-awakenings in the RERA have a negative impact on the glucose metabolism and favor the gestational diabetes.


Eligibility criteria: Inclusion Criteria:

Pregnant woman in the 3rd quarter of pregnancy (24 to 32 weeks amennorhea).

* Presenting a gestational diabetes ou not (=controle group)
* Written and signed consent.

Exclusion Criteria:

* Twin pregnancy
* High blood pressure before pregnancy
* Diabetes diagnosed before pregnancy
* Left ventricular ejection fraction below 40%
* Alcohol consumption (more than 7 glaces/day), drugs of type hypnotic, sedative, opioids
* History of gestational diabetes or glucose intolerance
* Severe cronical respiratory impairment (severe asthma)
* Creatinine clairance below 60 mL/min

Primary outcomes:
measure: Respiratory Disturbance Index
timeFrame: 4 month
Secondary outcomes:
measure: Air flow debit associated to micro awaking during sleep
timeFrame: 4 month
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: AP-HM
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
Clinical trial NCT05101642: Guided Creeping Technique (GCT) in Treating Gingival Recession
Official title: Guided Creeping Technique (GCT) as a Novel Minimally Invasive Approach in Treating Gingival Recession - Single Arm Preliminary Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession
Keywords: Minimally Invasive Surgery
Tunneling Techniques
Gingival Recession
Creeping Attachment
Lead sponsor: October 6 University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2021-11-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A novel minimally invasive guided creeping technique (GCT) is suggested to treat gingival recessions.

Detailed description: Background: Coronally advanced flap with connective tissue grafting in a conventional or minimally invasive approaches includes massive soft tissue reflection that reduce soft tissue support and compromise vascularity around the grafted material. In an attempt to preserve soft tissue support, graft stability and maximizing graft protection in treating recession defects the present novel minimally invasive guided creeping technique (GCT) is suggested.

Methods: Twelve patients, each contributing a single Cairo RT1 GR defect, were treated by guided creeping technique and completed the 6 months follow up. Clinical, evaluations were performed and differences among groups were analyzed.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Systemically and periodontally healthy
* Presence of isolated buccal Cairo RT1 gingival recessions
* An identifiable CEJ
* Affected teeth with at least 2mm attached gingiva.

Exclusion Criteria:

* Smokers
* Pregnancy
* Using antiepileptic drugs
* Using antibiotics for at least 20 days before surgery

Primary outcomes:
measure: Recession Coverage
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Keratinized Tissue Width
timeFrame: Change from baseline to 6 months
measure: Keratinized Tissue Thickness
timeFrame: Change from baseline to 6 months
Other outcomes:
measure: Patient Reported Outcome
timeFrame: Through 14 days
Locations:
city: Giza
country: Egypt
facility: October 6 University
Study officials:
affiliation: Faculty of Dentistry, October 6 University
name: Ahmed Y Gamal, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00108342: Nicotine Delivery Systems: Research & Treatment
Official title: Nicotine Delivery Systems: Research and Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Smoking
Keywords: nicotine
drug therapy
Smoking Cessation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-04-15
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether sampling nicotine replacement treatments (NRTs) is superior to learning about them by computer. Testing also covers preferences among the treatments. Subjects will be enrolled veterans who smoke.

Hypothesis: Direct experience ("sampling") of NRTs will increase knowledge about NRTs, motivation/confidence, use of NRTs and quit attempts in contrast to learning about NRTs by computer.

Detailed description: The study was designed to compare sampling of several nicotine replacement treatments (NRTs) in contrast to a computer learning control. The NRTs include: 2 dosages of nicotine gum, 2 dosages of nicotine lozenges and 2 dosages of oral nicotine inhalers. In the sampling group, each participant tries each of the 6 NRTs for 3 minutes. In the control, the individuals read about the treatments. Dependent measures include: quit attempts, use of NRTs, preferences among NRTs, and learning and motivation.

Eligibility criteria: Inclusion Criteria:

* Must be enrolled veteran who smokes.

Exclusion Criteria:

* Any event or condition that could be exacerbated by the local effects of nicotine treatments (e.g., throat or stomach problems; any kind of wheezing from a condition or medication)
* other criteria as determined by PI and study physicians
* reactions to menthol (inhaler) or to aspartame (lozenge)

Primary outcomes:
measure: Quit Attempts, Use of NRTs, Preference Among NRTs
timeFrame: At testing, at follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West LA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West LA
name: Nina G. Schneider, PhD
role: PRINCIPAL_INVESTIGATOR
References: