louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02801630: An Evaluation of the Effect of a Surface Acoustic Wave Patch Device on the Symptons of Trigeminal Neuralgia
Official title: An Evaluation of the Effect of a Surface Acoustic Wave Patch Device on the Symptons of Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trigeminal Neuralgia
Lead sponsor: Rosenblum, Jonathan I., DPM
Sponsor class: INDIV
Collaborators: name: Nanovibronix
First posted: 2016-06-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a double blinded randomized control trial of a Surface Acoustic Wave Patch device for the treatment of Trigeminal Neuralgia. This will be a crossover study for the group that receives the sham device. Subjects will be monitored for subjective criteria of pain and quality of life, as well as objective measurement of analgesic usage.

Detailed description: This study is a double blinded randomized control trial of a Surface acoustic wave patch device for the treatment of Trigeminal Neuralgia. All subjects will be enrolled for a 14 day lead up period, where baseline measures of pain, quality of life and analgesic use will be recorded.

During the first month of the study subjects will be randomized into a sham or active device group. Both groups will be assessed every two weeks for pain, quality of life and analgesic use. After 4 weeks, those subjects in the sham group will be crossed over into the active group. Both groups will continue to be assessed biweekly through months 2 and 3.

After 3 months of treatment a final assessment will be conducted and the results evaluated.

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Diagnosed with trigeminal neuralgia refractory to medical treatment (modified BNI V).

Exclusion Criteria:

* Male or female, under the age of 18. Active illicit drug use Pregnancy. Psychiatric illness which may prevent the patient from participation in the study.

Anesthesia dolorosa with pain greater than or equal to 3/10 Dental implants. Other known pathology of the trigeminal nerve including iatrogenic anesthesia dolorosa.

Cancer and bone metastases.

Primary outcomes:
measure: Pain
timeFrame: 90 days
Secondary outcomes:
measure: Quality of Life
timeFrame: 90 days
measure: Rescue Drug Use
timeFrame: 90 days
Other outcomes:
Locations:
city: Elmsford
country: United States
facility: NanoVibronix
state: New York
Study officials:
affiliation: Sponsor Representative
name: William Stern
role: STUDY_DIRECTOR
References:
Clinical trial NCT02743130: Effects of Berry Nectars Sweetened With Inverted Sugar on Post-meal Blood Sugar
Official title: Postprandial Glycemic Response to Berry Nectars Containing Inverted Sugar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia, Postprandial
Keywords: Berries
Blackcurrant (Ribes nigrum)
Lingonberry (Vaccinium vitis-idaea)
Sucrose
Inverted sugar
Postprandial glucose response
Postprandial insulin response
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
Collaborators: name: Finnsugar Ltd
First posted: 2016-04-19
Enrollment: 18
Sex: ALL
Minimum age (years): 25
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Berries have been shown to improve postprandial glucose and insulin responses to sucrose. During processing and storage of berry products, sucrose is inverted to glucose and fructose. The effects of berries on the glycemic response induced by inverted sugar are not known. The purpose of this study is to determine whether berries are effective in lowering the postprandial glucose and insulin responses induced by inverted sugar.


Eligibility criteria: Inclusion Criteria:

* BMI 20-28 kg/m2
* Normal fasting plasma glucose

Exclusion Criteria:

* Smoking
* Diabetes or other chronic disease
* Antibiotic medication within the past 3 months
* Blood donation within the past month

Primary outcomes:
measure: Plasma glucose response
timeFrame: 2 hours
Secondary outcomes:
measure: Plasma insulin response
timeFrame: 2 hours
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland
Study officials:
affiliation: Senior Scientist
name: Riitta Törrönen, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01677130: Standardized Application of High Frequency Oscillatory Ventilation in the Acute Respiratory Distress Syndrome (ARDS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Keywords: Clinical efficacy
safety
of HFOV treatment
of patients
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2012-08-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients of ARDS age\> 18 years

Brief summary: The Acute Respiratory Distress Syndrome (ARDS) is a clinical syndrome of progressive dyspnea and refractory hypoxemia caused by various reasons. Although in recent years a variety of supportive care measures have significant progress, but the mortality rate of patients with ARDS is still as high as 35-40%. Mechanical ventilation is one of the main treatments with ARDS, which is widely used in clinical. The rational mechanical ventilation strategy can improve the oxygenation of patients with ARDS and reduce lung injury. Patients with ARDS usually have alveolar epithelial and pulmonary capillary endothelial injury, and the lesion has heterogeneity. The protective mechanical ventilation strategies chosen by patients with ARDS in clinical practice are gradually being accepted and applied. The High-frequency oscillatory ventilation (HFOV) is a ventilation way with high respiratory rate and low tidal volume. Compared with conventional mechanical ventilation, HFOV may be able to more effectively improve oxygenation and reduce ventilator-associated lung injury. HFOV and protective ventilation strategy in ARDS is consistent with an important position in the treatment of ARDS, but not been widely adopted in clinical practice and is still only as a salvage treatment. Therefore, this study intends to use HFOV treatment with conventional mechanical ventilation by matching the cases in patients with ARDS. By comparing the influences of the patient's condition and mortality with HFOV, the clinical efficacy, safety, and health economics effectiveness of HFOV are further investigated and adaption time and parameter settings of HFOV are explored, which provide better treatment options for patients with ARDS and improve their prognosis.


Eligibility criteria: Inclusion Criteria:

* age\> 18 years;
* lung protective ventilation (tidal volume 4-6ml/kg), airway plateau pressure is still higher than 30cmH2O, or the failure of conventional mechanical ventilation pneumothorax, bronchopleural fistula in patients with ARDS; of ARDS diagnosis in line with the 2012 Berlin ARDS diagnostic criteria.
* be able to sign informed consent.

Exclusion Criteria:

* severe pulmonary hemorrhage;
* severe intracranial high pressure;
* large airway stenosis and airway obstruction.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06732830: Clinical Trial to Assess the Effectiveness of I+Med's DayDrop Advanced Ophthalmic Drop
Official title: Clinical Trial for the Evaluation of I+Med's DayDrop Advanced Ophthalmic Drop in Improving Signs and Symptoms of Mild/Moderate Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Keywords: Dry eye
DayDrop
Ophtalmic Tears
Lead sponsor: i+Med S.Coop.
Sponsor class: INDUSTRY
Collaborators: name: Bioaraba Health Research Institute
First posted: 2024-12-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quasi-experimental before-after clinical trial.
Primary purpose: TREATMENT

Brief summary: Clinical trial conducted with the aim of evaluating changes in the signs of dry eye through the change in the amount of tears produced, measured through the Schirmer test. It will be performed in 45 patients diagnosed with mild/moderate dry eye who meet the inclusion/exclusion criteria. Follow-up will be 12 weeks with a maximum of 4 visits.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes over 18 years of age.
* Patients diagnosed with mild-moderate dry eye who meet the following characteristics: Schirmer test ≥3 and ≤ 10 mm; BUT test ≥5 and ≤ 10 seconds and OSDI ≥13 and ≤ 33.
* Patients without other ophthalmologic pathologies.
* Have ability to self-administer drops.
* Have ability to understand the Patient Information Sheet.
* Sign the Informed Consent.

Exclusion Criteria:

* Patients diagnosed with severe dry eye.
* Ingestion of parasympathomimetic or antipsychotic medications .
* Glaucoma.
* Previous cataract surgery.
* Systemic treatment with corticosteroids or topical treatment with any ophthalmic medication except artificial tears in the week prior to the start of study treatment.
* Ocular infection or clinically significant inflammation.
* Ocular surgery in the 3 months prior to the study.
* Sjögren's syndrome.
* Stevens-Johnson syndrome.
* History of allergic conjunctivitis.
* Pregnancy or planned lactation.

Primary outcomes:
measure: Changes in the intensity of dry eye measured by Schirmer's test.
timeFrame: At baseline, in week 4 and in week 12
Secondary outcomes:
measure: Changes in dry eye signs through modifications in tear film thickness measured by Optical Coherence Tomography.
timeFrame: At baseline, in week 4 and in week 12
measure: Changes in dry eye signs through the tear breakup time measured by TBUT test.
timeFrame: At baseline, in week 4 and in week 12
measure: Changes in dry eye symptoms through the OSDI scale.
timeFrame: At baseline, in week 4 and in week 12
measure: Satisfaction with Treatment.
timeFrame: At Week 12
measure: Adverse events.
timeFrame: Through study completion, apprroximately 12 weeks
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Universitario Araba
state: Álava
Study officials:
References:
Clinical trial NCT03614130: Clinical Performance of a Silicone Hydrogel Contact Lens Following Six Nights of Extended Wear
Official title: Clinical Performance of a Silicone Hydrogel Following Six Nights of Extended Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: Contact Lens
Extended Wear
Overnight Wear
Contralateral Wear
Vision Correction
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2018-08-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens following 1 week of extended wear.

Detailed description: Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Baseline/Dispense; Day 2 Follow-up; and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.

Eligibility criteria: Key Inclusion Criteria:

* Able to understand and sign an Institutional Review Board/Ethics Committee-approved Informed Consent form.
* Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and in an extended wear modality a minimum of 1 night per week.
* Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
* Current Biofinity© lens wearer.
* Pregnant or breast-feeding.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Visual Acuity (VA) With Study Lenses, Collected by Eye
timeFrame: Day 1 Dispense; Day 2 Follow-up (ideally within 4 hours of awakening); Week 1 Follow-up/Exit
Secondary outcomes:
Other outcomes:
Locations:
city: Johns Creek
country: United States
facility: Alcon Investigative Site
state: Georgia
city: Brentwood
country: United States
facility: Alcon Investigative Site
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: CDMA Project Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT03159130: OnQ Pain Pump Effectiveness in Post Operative Pain Control in Bariatric Patients
Official title: OnQ Pain Pump Effectiveness in Post Operative Pain Control in Bariatric Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Morbid Obesity
Keywords: Pain pump catheters
bariatric surgery
OnQ pump
sleeve gastrectomy
continuous infusion catheter
Lead sponsor: William Beaumont Army Medical Center
Sponsor class: FED
First posted: 2017-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing a gastric sleeve procedure will be offered the opportunity to participate.

Brief summary: This study will assess the efficacy of OnQ pain catheters in pain reduction in the bariatric surgical population and seeks to identify if a quantifiable improved post-operative course occurs in patients receiving a catheter filled with local anesthetic versus that achieved by patients who receive a catheter filled with injectable saline.

Detailed description: This study will assess the efficacy of OnQ pain catheters in pain reduction in the bariatric surgical population. Approximately 12 to 15 weight reduction surgeries are performed at William Beaumont Army Medical Center each month. It is the current practice that each patient receiving the laparoscopic gastric sleeve or laparoscopic Roux-en-Y gastric bypass receive an OnQ pain catheter during the surgery to reduce post-operative pain. There have been limited studies to quantify the efficacy of these devices. This study will seek to identify if a quantifiable improved post-operative course occurs in patients receiving a catheter filled with local anesthetic versus that achieved by patients who receive a catheter filled with injectable saline.

Eligibility criteria: Inclusion Criteria:

* Meets criteria for Bariatric surgery
* Consents to be in protocol
* No local anesthetic allergy
* Will be having sleeve gastrectomy
* Doesn't have extensive scarring of abdominal wall that would prevent placement of OnQ catheter

Exclusion Criteria:

* declines to participate

Primary outcomes:
measure: Narcotic use
timeFrame: from admission to recovery room until discharge from the hospital (3-5 days)
Secondary outcomes:
Other outcomes:
Locations:
city: El Paso
country: United States
facility: William Beaumont Army Medical Center
state: Texas
Study officials:
affiliation: William Beaumont Army Medical Center
name: Gregory Peirce, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05213130: Blood Donation and Subjective Well-being
Official title: The Relationship Between Blood Donation and Subjective Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Donation
Happiness
Lead sponsor: Guangzhou Blood Center
Sponsor class: OTHER_GOV
First posted: 2022-01-28
Enrollment: 601
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Studies have suggested a positive relationship between prosociality and well-being. attempt to analyze the relationship between blood donation and subjective well-being, and try to figure out the moderators and mediators. Also, the investigators would like to compare difference of subjective well-being between donors who are explicitly presented with information that the participants' blood has saved patient's life and those who are not.


Eligibility criteria: Inclusion Criteria:

* Whole blood donors with negative serological results.

Exclusion Criteria:

* Whole blood donors with positive or suspicious serological results.

Primary outcomes:
measure: The scores of the subjective well-being in the questionnaire
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Blood Center
state: Guangdong
Study officials:
References:
Clinical trial NCT05107830: Phenotyping of Primary Hyperoxaluria
Official title: Phenotyping of Primary Hyperoxaluria in Children and Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Hyperoxaluria
Keywords: Primary hyperoxaluria
Autosomal recessive
Urolithiasis.
Nephrocalcinosis
Renal failure
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 186
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major or minor subject having undergone genetic research for primary hyperoxaluria between 01/01/2015 and 31/12/2019

Brief summary: 985 / 5000 Résultats de traduction Primary hyperoxaluria is a rare autosomal recessive disease with an estimated prevalence of around 1 to 3 cases per million population. The most frequent attacks are urolithiasis disease and nephrocalcinosis, ultimately leading to end-stage chronic renal failure. The phenotype of this pathology is very heterogeneous, making the diagnosis difficult.

There is currently a significant diagnostic delay. This is potentially due to atypical forms, or to insufficient clinicians' awareness of its research.

However, the early diagnosis of this pathology is essential, since end-stage chronic renal failure can be avoided or at least delayed with early and appropriate management.

The objective of the study is to describe the phenotype of currently diagnosed primary hyperoxaluria, in order to identify the classic presentations but also the characteristics of atypical presentations


Eligibility criteria: Inclusion criteria:

* Major or minor subject having undergone genetic research for primary hyperoxaluria between 01/01/2015 and 31/12/2019
* Major subject not having expressed, after information, the reuse of his data for the purposes of this research
* Child and holders of parental authority who have not expressed, after information, the reuse of their data for the purposes of this research

Exclusion criteria:

* Subject (or his parental authority if he is a minor) who has expressed his opposition to participating in the study
* Subject not residing in France
* Subject of foreign nationality
* Subject under tutorship or curatorship
* Subject under safeguard of justice

Primary outcomes:
measure: Retropsective study of classic presentations of atypical presentations of primitive hyperoxaluria and its characteristics of atypical presentations
timeFrame: Files analysed retrospectively from January 01, 2015 to December 31, 2019 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Néphrologie et Transplantation - Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT04746430: COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study
Official title: COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study: an Open-label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Covid19
Corona Virus Infection
Lead sponsor: General Practitioners Research Institute
Sponsor class: NETWORK
Collaborators: name: Huisartsenzorg Drenthe
First posted: 2021-02-09
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The COVID-19 coronavirus has led to a global pandemic of respiratory diseases with an increase in hospitalization and death risk. To keep COVID-19 manageable for healthcare, early treatment is urgently needed to avoid hospitalization. Dexamethasone can dampen the exaggerated cytokine response to COVID-19 and is a promising agent for preventing disease aggravation, hospitalization and death. However, the evidence on the effectiveness, safety and cost-effectiveness of dexamethasone treatment in primary care is inconclusive.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* A positive test for SARS-CoV-2
* A GP consultation for deteriorating COVID-19 symptoms

Additional inclusion criteria in order to be eligible for randomization to the trial:

- Exercise-induced desaturation, defined as SpO2\<92% (\<90% for COPD patients) and/or an absolute drop of ≥4% in SpO2 after a 1-minute sit-to-stand test

OR

- SpO2\<92% (\<90% for COPD patients) in rest with GP's and patient's shared decision to keep patient at home despite this in itself being an indication for referral to hospital

Exclusion Criteria:

* Inability to understand and sign the written consent form
* Inability to perform saturation measurements or sit-to-stand test
* Not willing to be admitted to hospital
* On the discretion of the recruiting clinician if he or she deems a patient not eligible

The following criterion will be used to exclude patients from randomization to the trial:

* Contra-indication for dexamethasone

Primary outcomes:
measure: Hospitalization/death
timeFrame: 28 days
Secondary outcomes:
measure: Recovery
timeFrame: 28 days
measure: Disease severity
timeFrame: 28 days
measure: HCRU
timeFrame: 28 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: GPRI
Study officials:
affiliation: General Practitioners Research Institute
name: Janwillem Kocks, Prof
role: PRINCIPAL_INVESTIGATOR
References: