louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05129111: A Stimulator of the Salivary Vibration of the Parotid Glands
Official title: A Stimulator of the Salivary Excretion Based on Physical Vibration of the Parotid Glands.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Saliva Stimulated
Keywords: saliva
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The central idea of the device resides in transmitting the vibration generated by two vibrating modules to the two parotid glands through the superficial contact established between each vibrating module and the respective parotid gland, achieving the stimulation of both parotid glands simultaneously.
Primary purpose: TREATMENT

Brief summary: Oral dryness causes significant health problems both functional (difficulty speaking, chewing and swallowing) and structural problems in teeth (increased number of infections) and oral mucosa. The main objective of this study is to show an alternative treatment to help to stimulate the salivary secretion thus improving the quality of life of the patient. In this study, a salivary stimulation equipment using vibrotactile stimuli is shown. The system has been placed bilaterally in the parotid glands and assessed the efficacy of the salivary secretion by sialometry before and after the stimulation. The new proposal is capable of stimulating salivary secretion, in a significative way after 7 minutes of use, at least in the cases analyzed, and fulfills low-cost, easy-to-use and safe technical restrictions. In this setting, this paper suggests the performance of a deep clinical trial to measure the exact efficacy of the prototype and the times and frequencies needed to state the optimal treatment depending in each case


Eligibility criteria: Inclusion Criteria:

* Sialometria \<01,mL /5 min
* Test Thomson

Exclusion Criteria:

* Not signing informed consent
* Bad medical status

Primary outcomes:
measure: sialometry
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Lopez-Jornet Pia
state: N/A = Not Applicable
Study officials:
References:
citation: Fernandes MS, Castelo PM, Chaves GN, Fernandes JPS, Fonseca FLA, Zanato LE, Gaviao MBD. Relationship between polypharmacy, xerostomia, gustatory sensitivity, and swallowing complaints in the elderly: A multidisciplinary approach. J Texture Stud. 2021 Apr;52(2):187-196. doi: 10.1111/jtxs.12573. Epub 2020 Nov 25.
citation: Salimi F, Saavedra F, Andrews B, FitzGerald J, Winter SC. Trans-cutaneous electrical nerve stimulation to treat dry mouth (xerostomia) following radiotherapy for head and neck cancer. A systematic review. Ann Med Surg (Lond). 2021 Feb 3;63:102146. doi: 10.1016/j.amsu.2021.01.094. eCollection 2021 Mar.
Clinical trial NCT01773811: Effects of Narrative Writing Duration and Post-writing Processing Instructions on PTSD
Official title: Effects of Narrative Writing Duration and Post-writing Processing Instructions on PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
Keywords: Posttraumatic Stress Disorder (PTSD)
Narrative Writing
Lead sponsor: University of Mississippi, Oxford
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 49
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 current study proposes to directly measure how processing after participating in written disclosure about a traumatic life event affects physical and psychological outcomes.

Detailed description: Previous research has established the potential for narrative writing about traumatic events to result in positive benefits for physical and psychological health. Research has also provided evidence that written disclosure may reduce post-traumatic stress disorder (PTSD) symptoms. Several mechanisms of action have been proposed to explain why written disclosure produces positive benefits, but all have focused on processes occurring during the writing session. It has been suggested, however, that additional processing may occur after the writing exercises are over, yet no research has studied the influence of this processing on outcomes. The current study proposes to directly measure how processing after participating in written disclosure affects physical and psychological outcomes.

Eligibility criteria: Inclusion Criteria:

* Experienced a traumatic life event (DSM-IV-TR Criterion A)
* Currently experiencing clinically significant levels of PTSD symptoms

Exclusion Criteria:

* Currently receiving psychotherapy
* On medication that is not stable (i.e. medication has been changed within the past 6 weeks)

Primary outcomes:
measure: Level of PTSD symptoms as measured by the Clinician Administered PTSD Scale
timeFrame: 1 month after final writing session
Secondary outcomes:
measure: Physical health
timeFrame: 1 month after final writing session
Other outcomes:
Locations:
city: University
country: United States
facility: The University of Mississippi
state: Mississippi
Study officials:
affiliation: University of Mississippi, Oxford
name: Tom Lombardo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00438711: Surgical Decision Making Among People With Inflammatory Bowel Disease
Official title: Surgical Decision Making Among People With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-02-22
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with inflammatory bowel disease who respond to advertisements and study announcements or who were treatment at the recruitment site and referred by their physician.

Brief summary: This is a study for people with inflammatory bowel disease ("IBD"--that is, ulcerative colitis, Crohn's colitis, or indeterminate colitis). We are studying how people with IBD decide to have surgery when a doctor has told them they should think about having their colon (large bowel) removed. This surgery is called a "colectomy." Patients will be asked to fill out a questionnaire that takes about 60 to 90 minutes to complete. Questions ask about patients' background (age, etc.) and their IBD. They also ask about patients' decision to have surgery or not to have surgery. For instance, what kinds of things did they think about? Some questions ask about other people who affected the choice and how patients felt about the help they got from others. People who wish to join the study will receive payment to thank them for their time.

* Patients must be at least 18 years old
* Patients must speak English
* Patients must have been told by their doctor to think about having surgery to take out their colon to (a) lower their risk for cancer or (b) because they have pre-cancer (called "dysplasia")
* Patients do not need to have had the surgery--they may have already had the surgery, they may not have had it yet, or they may have decided they do not want to have it


Eligibility criteria: Inclusion Criteria:

1. Have been told by a doctor that they have ulcerative colitis, Crohn's disease, or indeterminate colitis.
2. Be at least 18 years old
3. Speak English
4. Have been told by a doctor to think about having surgery to take out their colon ("colectomy") within the last 3 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Christine Rini, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02854111: Using of Ice Cream for Diagnosis of Diabetes Mellitus
Official title: Using of Ice Cream for Diagnosis of Diabetes Mellitus and Impaired Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 104
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The overall global prevalence of type 2 diabetes mellitus (DM) is rising. Based on the latest Thai National Health Examination Survey, an estimated 3.2 million people had DM, of whom one-third was undiagnosed. The inexpensive oral glucose tolerance test (OGTT) is a more sensitive and reliable test of DM than fasting plasma glucose (FPG) or HbA1c, and is recommended for diagnosing DM and impaired glucose tolerance (IGT). Although the OGTT provides useful diagnostic information, poor patient tolerance of glucose solutions is inevitable.

Detailed description: Regarding the diagnosis of DM, oral glucose tolerance test (OGTT) identifies about 2% more individuals than does fasting plasma glucose (FPG). Hence OGTT is the method that has high sensitivity compared to other methods for diagnosis of IGT (impaired glucose tolerance) and diabetes. However, standard OGTT with 75-g glucose has poor patient tolerance and might cause reactive hypoglycemia. The alternatives for 75-g glucose would help for screening of DM with better tolerance. There were previous studies investigated substitutes for oral glucose solution with cookies and muffin. In the present study we hypothesized that an alternative food such as ice cream, a favorite dessert, can use for evaluation of the diagnosis of DM and IGT instead of standard 75-g glucose.

Eligibility criteria: Inclusion Criteria:

* healthy volunteer
* agree to participate by written informed consent

Exclusion Criteria:

* previous history of diabetes mellitus
* pregnant woman
* hospitalised patients
* underlying disease of liver and kidney disease
* who take any medications that interfere with plasma glucose levels such as steroid

Primary outcomes:
measure: The correct diagnosis of diabetes mellitus
timeFrame: 2 hours
Secondary outcomes:
measure: The correct diagnosis of impaired glucose tolerance
timeFrame: 2 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University
Study officials:
affiliation: Ramathibodi Hospital
name: Chutintorn Sriphrapradang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chanprasertpinyo W, Bhirommuang N, Surawattanawiset T, Tangsermwong T, Phanachet P, Sriphrapradang C. Using Ice Cream for Diagnosis of Diabetes Mellitus and Impaired Glucose Tolerance: An Alternative to the Oral Glucose Tolerance Test. Am J Med Sci. 2017 Dec;354(6):581-585. doi: 10.1016/j.amjms.2017.08.007. Epub 2017 Aug 18.
Clinical trial NCT05543811: The Influence of Food for Special Dietary Use - Spread Enriched With 5-hydroxytryptophan, Theanine and Gamma-aminobutyric Acid on Psychophysiological Functions of Subjects Without Meaningful Organic and Cognitive Pathology
Official title: The Influence of Food for Special Dietary Use - Spread Enriched With 5-hydroxytryptophan, Theanine and Gamma-aminobutyric Acid on Psychophysiological Functions of Subjects Without Meaningful Organic and Cognitive Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Memory; Disturbance, Mild
Emotional Regulation
Concentration Ability Impaired
Lead sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Sponsor class: OTHER
Collaborators: name: Group of companies EFKO
name: Russian Science Foundation
First posted: 2022-09-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a single-centre, single-blind, two-arms, controlled study to assess the efficacy and safety of food for special dietary use enriched with 5-hydroxytryptophan, L-theanine and Gamma-aminobutyric acid in generally healthy subjects with no cognitive disturbances


Eligibility criteria: Inclusion Criteria:

* willingness to participate;
* age of 18-50 years

Exclusion Criteria:

* pregnancy or breastfeeding;
* significant somatic or psychological disorders

Primary outcomes:
measure: change in cognitive function
timeFrame: two weeks
measure: change in cognitive function2
timeFrame: two weeks
measure: change in functional status
timeFrame: two weeks
measure: change in anxiety and depression
timeFrame: two weeks
Secondary outcomes:
measure: change in food's taste monotony
timeFrame: two weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Study officials:
affiliation: Federal Research Center of Nutrition and Biotechnology
name: Vasily Isakov, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT03322111: Assessment of Cyclofusion Capabilities of Normal Subjects and Patients With 3D Dynamic Random-dot Stereograms
Official title: Assessment of Cyclofusion Capabilities of Normal Subjects and Patients With 3D Dynamic Random-dot Stereograms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cyclofusion Competence
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: With this study the investigator wants measure the individual cyclofusion competence from healthy subjects and patients suffering from Strabismus with a only binocularly visible threedimensional Landolt-C stimulus. For this the participant has to look at a 3-D monitor with shutter glasses. The participant is sitting in 2 meter distance in front of the monitor. On the monitor appears the Landolt-C stimulus as a dynamic Random-Dot Stimulus. As long as the participant can fuse the stimulus he will be able to see the Landolt C-ring threedimensional. The participant is then ask to tell in which direction the notch of the Landolt-C ring points out. Once a critical degree of cyclotorsion is reached the participant will no longer be able to see the Landolt C ring and the individual cyclofusion competence is reached.


Eligibility criteria: Inclusion Criteria:

* Visual acuity \>0,4; Stereopsis

Exclusion Criteria:

* Visual acuity \<0,4; no Stereopsis

Primary outcomes:
measure: In- and excyclofusion competence in healthy individuals. Change in In- and excyclofusion competence in patients who need a strabismus surgery before and 6 month after surgery.
timeFrame: Once in healthy individuals. Before and 6 month after a (independent from the study) performed strabismus surgery.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05121311: Assessment of Neonatal Hyperbilirubinemia by NeoprediX B.1 Algorithm
Official title: Assessment of Neonatal Hyperbilirubinemia by NeoprediX B.1 Algorithm - Prospective Observational Study -
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Newborn Jaundice
Keywords: newborn jaundice
Hyperbilirubinaemia
Lead sponsor: NeoPredix AG
Sponsor class: INDUSTRY
Collaborators: name: Center for Pediatric Clinical Studies (CPCS)
First posted: 2021-11-16
Enrollment: 455
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newborn infants

Brief summary: Due to actual standard of neonatal care bilirubin is monitored in neonates several times after birth to avoid hyperbilirubinemia. As the peak is often one or two days after discharge from hospital a more precise predication than the actual one is desirable to avoid needlessly follow-ups. The precision of an algorithm to predict bilirubin values 24-48h into the future is evaluated in this study.

Detailed description: Neonatal jaundice is common and mostly transient without need for intervention. To identify infants at risk of bilirubin toxicity, bilirubin is measured several times after birth and before discharge home. As the peak bilirubin concentrations are reached at days 4-6 after birth, and most infants are discharged home around 48 hours after birth, parents are often asked to return to hospital one or two days after discharge with their newborn baby to have the bilirubin value checked in order to prevent that hyperbilirubinemia requiring treatment is not missed. A precise prediction of the course of bilirubin values based on the measurements done during the initial hospital stay after birth would be desirable to avoid unnecessary follow ups (both for the families and the health care system).

This study aims to evaluate the precision of the NeoprediX B1 algorithm. This algorithm predicts bilirubin values 24-48h into the future based on preceding values and some clinical variables. Five different scenarios will be explored, differing in the type, number and timepoints of measurements used for the prediction as well as the timepoint that is to be predicted.

Eligibility criteria: Inclusion Criteria:

* Newborn infant
* gestational age at birth ≥ 34+0/7 weeks

Exclusion Criteria:

* Birth weight \< 1500g
* Gestational age at birth \> 42+6/7 weeks
* Genetically defined syndrome
* Severe congenital malformation adversely affecting life expectancy or admission for a priori planned palliative care
* Parents not fluent in German

Primary outcomes:
measure: Precision of predicted bilirubin value
timeFrame: 8 hours to 144 hours after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: KUNO Kinderklinik St. Hedwig
city: Tübingen
country: Germany
facility: University Children's Hospital
Study officials:
affiliation: University Children's Hospital Tübingen
name: Axel Franz, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02790411: Adjustment Exploratory Protocols and Functional Evaluation of New Non Invasive Devices in Healthy Volunteers
Official title: Adjustment Exploratory Protocols (MagnetoEncephaloGraphy Study : MEG, ElectroEncephaloGram : EEG, Magnetic Resonance Imaging : MRI, Functional MRI : MRIf, Motor Platform) and Functional Evaluation of New Non Invasive Devices (REX BIONICS Exoskeleton) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Parameters, sequences or paradigms optimisation in view of data quality and relevancy improvement.

Detailed description: Various tests are needed for methodological optimization of the several devices (per-operative MRI, MEG, EEG, SPECT-CT, motor platform) of the technological platform.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Male or female aged over 18 years
* Registered in the French social security scheme
* Signed informed consent

Exclusion Criteria:

* Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG)
* Contraindication to Magnetic resonance imaging (MRI)
* All categories of protected persons

Primary outcomes:
measure: Magnetic brain activity
timeFrame: 2 hours
measure: Brain imaging
timeFrame: 2 hours
measure: Electrical brain activity
timeFrame: 2 hours
measure: Motor activity parameters
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CLINATEC
Study officials:
References:
Clinical trial NCT01282411: Anatomic Outcomes Following Ozurdex Injections
Official title: Anatomic Outcomes Following Ozurdex Injection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Vein Occlusions
Lead sponsor: Barnes Retina Institute
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2011-01-25
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Branch retinal vein occlusion (BRVO) Central retinal Vein occlusion (CRVO)

Brief summary: Ozurdex(TM) has recently been FDA approved for use in macular edema secondary to retinal vein occlusion. It remains unclear how quickly the drug works and for how long as the initial studies did not have frequent anatomic monitoring. This study will utilize frequent Spectral domain OCT imaging to better understand the onset of treatment effectiveness and duration of action on the anatomic thickness of the retina, in addition to distinguishing structural abnormalities of responders from non-responders.

Detailed description: Focal laser therapy has been the gold standard for the treatment of macular edema secondary to branch vein occlusion (BRVO), though it has not been shown to be effective for central vein occlusion (CRVO). Intravitreal corticosteroids have been shown in many case series to be effective at diminishing macular edema secondary to both BRVO and CRVO. Sustained drug delivery models have been sought after to relieve the need for frequent injections. Ozurdex has recently been found to be effective for the treatment of macular edema following BRVO or CRVO and has been approved by the FDA for these indications. The onset of effectiveness and duration of action on the anatomic thickness of the retina have not yet been demonstrated. In addition, it is uncertain as to when the clinician can label the patient as a responder or nonresponder. We also believe this study will help identify patients that may need more frequent dosing schedules.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with BRVO/CRVO who are otherwise eligible to receive treatment with Ozurdex (TM)

Exclusion Criteria:

* Patients younger than 21 years of age, unwilling or unable to grant informed consent, participation in a clinical trial within the 30 days prior to enrollment. Patients receiving any other ocular therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Barnes Retina Institute
state: Missouri
Study officials:
affiliation: Barnes Retina Institute
name: Gaurav K Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: