louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05527366: Effect of Auricular Vagus Stimulating in Non Specific Chronic Neck Pain
Official title: The Effect of Auricular Vagus Stimulating on Pain, Disability and Sleep in Non Specific Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Vagus
Autonomic Nervous System
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to compare the efects of conventional treatment and vagus nerve stimulation on pain, normal joint movement, disability and sleep in non-specific chronic neck pain.

36 patients aged between 18 and 65 years with non-specific neck pain participated in our randomly planned study. All these patients were divided into 2 groups. Demographic and physical characteristics of the patients were recorded. The first group was treated with auricular vagus nerve stimulation. Conservatire treatment that consists of hotpack, transcutaneous electrical nerve stimulation (TENS) and therapeutic ultrasound was applied to the second group. In addition to their treatment, some home exercises were given and tought. Pain was assessed with a visual analog scale (VAS). Muscle strength was evalvated with a digital hand dynamometer. Neck normal joınt motion was evaluated with goniometer clinometer which is a mobile phone application. While disability was mensured with the neck disability index, sleep quality was evalvated with the Pittsburg sleep questionnaire. All the measurements were recorded before the trearment and after the 15 session treatment.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* people with non-specific neck pain

Exclusion Criteria:

* Who has neurological problems,
* who has vision and hearing loss,
* who has a tumor and infection in the cervical region,
* who has undergone surgery related to the cervical region,
* who has had a cervical streroid injection in the last 3 months

Primary outcomes:
measure: Pain Severity
timeFrame: 3-week change in pain intensity
measure: Muscle strength Measurement
timeFrame: 3-week change in muscle strength
measure: Joint Range of Motion Measurement
timeFrame: 3-week change in Range of motion
measure: Assessment of dysability
timeFrame: 3-week change in dysability
measure: Evaluation of sleep quality
timeFrame: 3-week change in sleep quality
Secondary outcomes:
Other outcomes:
Locations:
city: Tuzla
country: Turkey
facility: Emine Atıcı
state: İstanbul
Study officials:
References:
Clinical trial NCT01979666: Nitrate Patch Use as Treatment of Knee AVN
Official title: the Effect of a Nitrate Patch on the Healing Process of AVN of the Knee
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Necrosis, Avascular, of Bone
Keywords: Knee AVN, Nitrates
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-11-08
Enrollment: 30
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: TREATMENT

Brief summary: The pathogenesis of AVN includes a defective blood supply to the knee joint. Local nitrates induce peripheral vasodilation and may improve blood supply to the affected tissue.

This study aims to test whether the use of a nicotine patch may accelerate the healing process from AVN of the knee.

Detailed description: The main purpose of this study is to examine whether treatment with a local nitrate patch will improve MRI findings and clinical outcomes in patients with AVN of the knee.

This is a double-blind prospective study that will include 50 adult volunteers, randomly assigned to a "nitrate" group that will be given a nitrate patch, and a "placebo" group that will be given a placebo patch.

The following outcomes will be measured:

* MRI findings before and after the patch treatment
* Use of analgesics
* Subjective pain relief.

Eligibility criteria: Inclusion Criteria:

* adult patients (18-80 y.o)
* diagnosis of AVN according to MRI

Exclusion Criteria:

* Terminal illness
* Cognitive impairment / any condition disturbing informed concent.
* Nitrate intolerance
* Patients using Cyclic GMP inhibitiors

Primary outcomes:
measure: Reduction in bone substrate edema
timeFrame: 6 weeks
Secondary outcomes:
measure: other MRI changes
timeFrame: 6 weeks
measure: analgesics use
timeFrame: 6 weeks
measure: pain severity
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: avi livneh
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: arik asman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03186066: Endoscopic Treatment of the Buried Bumper Syndrome: Comparison of the Flamingo Device Versus Standard Therapy
Official title: A Prospective Randomized Controlled Multicenter Trial for Evaluation of the Flamingo Device in Endoscopic Treatment of the Buried Bumper Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Buried Bumper Syndrome
Lead sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 52
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: Percutaneous endoscopic gastrostomy (PEG) is a method for nutrition delivery for patients with insufficient oral intake. A rare but severe complication of PEG is the Buried Bumper Syndrome (BBS). In BBS the internal fixation device of the PEG migrates along the stoma chanel. The internal fixation disc becomes covered by gastric mucosa, which causes loss of patency, fixation of the PEG and possible leakage around the PEG.

BBS can be treated endoscopically by dissecting the overgrowing tissue with endoscopic submucosal dissection (ESD) knifes. A new and alternative approach is the use of the Flamingo device, which is inserted over the PEG and then is used to radially dissect the overgrowing tissue with a cutting wire.

In this study both methods, the standard method using an ESD knife and the Flamingo device, are compared in a randomized controlled open-label trial. Primary endpoint is the time needed for PEG removal.


Eligibility criteria: Inclusion Criteria:

* Endoscopy proven Buried Bumper Syndrome
* PEG or Jet-PEG

Exclusion Criteria:

* Major Coagulation disorder
* Percutaneous endoscopic jejunostomy or use of a ballon fixed device

Primary outcomes:
measure: Time for Removal of PEG
timeFrame: Assessed at day 1 (day of intervention)
Secondary outcomes:
measure: Success rate
timeFrame: Assessed at day 1
measure: Complications
timeFrame: Assessed during follow-up for up to ten days
Other outcomes:
Locations:
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
Study officials:
References:
Clinical trial NCT03375866: Effects of Mixed Nut Consumption on Satiety and Weight Management
Official title: Effects of Mixed Nut Consumption on Satiety and Weight Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Satiety
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The first goal of the proposed study is to determine acute and long-term effects of mixed nuts (almonds, hazelnuts, pecans, pistachios, walnuts, and peanuts) on metabolic parameters and weight management. While numerous studies have shown the beneficial effects of nuts on promoting negative energy balance and weight loss, mechanistic studies exploring how the inclusion of nuts in the diet promotes a negative energy balance and weight loss have not been conducted. The second goal is to determine the mechanisms by which mixed nut consumption regulates of food intake and body weight.


Eligibility criteria: Inclusion Criteria:

* 18-55 years old
* BMI 27-40

Exclusion Criteria:

* Smoker
* Pregnant woman
* Required dietary supplement use
* Required medication of metabolic disorders
* Allergy to nuts or gluten

Primary outcomes:
measure: Change of Satiety
timeFrame: 0, 20, 40, 60, 90 and 120 minutes post snack consumption
measure: Change of glucose level
timeFrame: Baseline, 40 minutes post snack consumption, and 8 weeks and 16 weeks post daily consumption
measure: Change of insulin level
timeFrame: Baseline, 40 minutes post snack consumption, and 8 weeks and 16 weeks post daily consumption
measure: Change of cholesterol levels
timeFrame: 8 weeks and 16 weeks post daily consumption
measure: Change of Lp(a)
timeFrame: 8 weeks and 16 weeks post daily consumption
Secondary outcomes:
measure: Change of microbiome
timeFrame: 8 weeks and 16 weeks post daily consumption
Other outcomes:
Locations:
city: San Diego
country: United States
facility: School of Exercise and Nutritional Sciences, SDSU
state: California
Study officials:
References:
Clinical trial NCT04383366: Agreement and Accuracy of Different Devices Corneal Measurements
Official title: Agreement and Accuracy of Different Devices for the Measurement of Corneal Thickness and Corneal Curvature in Patients With Keratoconus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 patients with keratoconus will be recruited in the outpatient department of the Department of Ophthalmology.

Brief summary: To compare repeatability, reproducibility and agreement of both, AS- OCT and Scheimpflug imaging, for the measurement of corneal curvature and corneal thickness in patients with keratoconus.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 18 and 99 years
* Presence of keratoconus
* Signed informed consent

Exclusion Criteria:

* Contact lens history within 5 days
* Pathologic changes of the lid or conjunctiva on slit-lamp examination
* History of corneal ocular surgery/Previous corneal cross-linking

Primary outcomes:
measure: maximum K-value
timeFrame: 1 day
Secondary outcomes:
measure: Simulated minimum and maximum K-value
timeFrame: 1 day
measure: Mean K-values
timeFrame: 1 day
measure: Central Corneal thickness
timeFrame: 1 day
measure: Thinnest corneal point
timeFrame: 1 day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Ophthalmology
Study officials:
affiliation: Medical University of Vienna
name: Gerald Schmidinger, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02978066: Postspinal Hypotension and Cardiac Performance in the Elderly
Official title: Is Postspinal Hypotension a Sign of Impaired Cardiac Performance in the Elderly? An Observational Mechanistic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARTHROPLASTY, REPLACEMENT; ANESTHESIA
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 65 years or older scheduled for hip or knee arthroplasty in spinal anaesthesia. Exclusion criteria were: (i) weight \<40kg; (ii) concomitant lithium medication; (iv) informed consent not obtained; (v) research team unavailable

Brief summary: Patients, scheduled for elective arthroplasty were monitored with Lithium Dilution Cardiac Output monitor (LiDCOplus™) before and 45 minutes after spinal anesthesia. Hypotension was defined as systolic blood pressure ≤ 100 mmHg or ≥ 30% decrease from baseline. Associations between hypotension and the hemodynamic changes after preanaesthetic fluid loading and spinal anesthesia were analysed by logistic regression analyses.


Eligibility criteria: Inclusion Criteria:

* hip or knee arthroplasty
* spinal anaesthesia
* age 65 years or more

Exclusion Criteria:

* weight \<40kg
* concomitant lithium medication
* written informed consent not obtained
* research team unavailable

Primary outcomes:
measure: Stroke volume in ml
timeFrame: 0-45 minutes after spinal anaesthesia
Secondary outcomes:
measure: Arterial blood pressure mmHg and change from baseline
timeFrame: 0-45 minutes after spinal anaesthesia
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01502566: Educational Intervention in Preventing Early Childhood Caries
Official title: A Cluster-randomized Trial of the Effectiveness of an Educational Intervention in Preventing Early Childhood Caries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Caries
Keywords: educational intervention
dentals caries
population
new populational caries prevention strategies.
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2011-12-30
Enrollment: 500
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective:

The aim of this study is to assess the effectiveness of an oral health educative intervention in preventing early childhood caries (ECC).

Methods:

The trial targets 0- to 12-month-old children and their mothers in Pelotas, Brazil. Twenty-four public health centres (clusters) were randomly selected and assigned to intervention or control group (12 clusters per intervention group). In each center, up to 30 children/mothers were selected and invited to participate in the trial. Each mother was interviewed in order to collect socio-economic and demographic variables. The intervention group received by means of a pamphlet the oral health instructions, which were emphasized with verbal instructions. Dental examination will be carried out after 1 year for all teeth surfaces to determine caries status.


Eligibility criteria: Inclusion Criteria:

* Children with 0 to 12 months

Exclusion Criteria:

* Children with teeth in mouth at the time of enrollment
* Children not living in Pelotas
* No sufficient information provided by the mother at the time of enrollment
* Systemic diseases

Primary outcomes:
measure: Caries status (dmfs)
timeFrame: after 12 months
Secondary outcomes:
measure: dental plaque index
timeFrame: after 12 months
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Federal University of Pelotas - School of Dentistry
state: RS
Study officials:
affiliation: Federal University of Pelotas
name: Maximiliano S Cenci, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Pelotas
name: Marina S Azevedo, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Pelotas
name: Ana R Romano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01996566: Fatty Acid Taste Thresholds: Caproic, Lauric, Oleic, Linoleic, Linolenic
Official title: Fatty Acid Taste Thresholds: Caproic, Lauric, Oleic, Linoleic, Linolenic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Taste Sensitivity
Fatty Acid Type
Keywords: taste
non-esterified fatty acids
threshold
sensitivity
human
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals between 18 and 60 years of age from any ethnic background who are in good health and are available for the next three months will be eligible.

Brief summary: Differences in human oral sensitivity for caproic, lauric, oleic, linoleic, and linolenic acids will be explored. Prior work indicates that there may be a learning effect in measuring detection thresholds for free fatty acids. This study is designed to determine the number of visits necessary to attenuate this learning effect and also to test whether this effect continues across different types of fatty acids or is specific to each fatty acid. This will aid in understanding how many visits are required to obtain reliable data and if less expensive fatty acids can be used to attenuate learning before testing thresholds for more expensive fatty acids.


Eligibility criteria: Inclusion Criteria:

* 18-60 years of age
* in good health
* available for 3 months

Exclusion Criteria:

* Participation in a different fat taste study in previous 6 months

Primary outcomes:
measure: Oral sensitivity to oleic, lauric, linoleic, linolenic and caproic acids measured by the ascending 3 alternative forced choice test as described in American Society and Testing and Methods E679
timeFrame: Measured at weekly intervals over 3 months
Secondary outcomes:
measure: DNA sequence of potential fatty acid receptors (e.g., CD36, GPR120, GPR48)
timeFrame: This will be collected at the final visit of the study, approximate 2-3 months from participant enrollment depending on how frequently the participant is able to come to the lab
measure: Amount of habitual dietary fat intake
timeFrame: Baseline
measure: Measurement of hunger
timeFrame: This will be measured at every study visit (21 visits plus 1 screening visit) over the 2-3 months of the study
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References:
citation: Running CA, Mattes RD. Different oral sensitivities to and sensations of short-, medium-, and long-chain fatty acids in humans. Am J Physiol Gastrointest Liver Physiol. 2014 Aug 1;307(3):G381-9. doi: 10.1152/ajpgi.00181.2014. Epub 2014 Jun 12.
Clinical trial NCT05724966: Anti-neoplastic Treatment, Based on PRO Data Reported Through a MHealth App Solution in Multiple Myeloma
Official title: Anti-neoplastic Treatment, Based on PRO Data Reported Through a MHealth App Solution in Multiple Myeloma - a Mixed Method Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Multiple Myeloma planned treatment with Bortezomib.

Brief summary: Pirmary endpoint: to examine the feasibility of using an mHealth app for reporting of side effects instead of a telephone call from the hospital staff together with examining the perspectives of patients with multiple myeloma and healthcare professionals of this new method for reporting side effects, and to assess organizational aspects. Usual procedure to assess side effect prior to cancer treatment with Bortezomib is a telephone call the day before. With this innovative method investigator aimed to give the patient more independence in their daily life and in that way improve their quality of life.

Detailed description: It is a prospective, clinical, parallel mixed-method design with a quantitative core and a qulitative supplementary component. There will be used a Mhealth app called "My Hospital".

Quantitative data will be acquired from time registrations performed by patients and nurses and will be descriptively analyzed applying a micro-costing approach, using cost data per individual. Qualitative data will be obtained from individual, semi-structured interviews with patients and one focus group interview with healthcare professionals and will be analyzed applying a hermeneutic approach.

Eligible for inclusion were patients with MM scheduled for Bortezomib. Moreover, patients should have access to a smartphone, be able to self-report side effects of Bortezomib using a smartphone app, and be willing to participate in a semi-structured interview.

Eligibility criteria: Inclusion Criteria:

* patients with MM scheduled for Bortezomib
* patients should have access to a smartphone
* patients should be able to self-report side effects of Bortezomib using a smartphone app, and be willing to participate in a semi-structured interview.

Exclusion Criteria:

* patients had to talk and read danish

Primary outcomes:
measure: Time registrations of side effects using an app
timeFrame: 18 months
measure: patient registration of side effects using an app
timeFrame: 18 months
Secondary outcomes:
measure: Qualitative perspectives interview
timeFrame: 16 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense Universitetshospital
name: Jannie Kirkegaard, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04759066: The HEALiX™ Intubated Patient (IP) Pilot Study
Official title: Assessment of an Alternative to Physical Wrist Restraints in Adult Intubated Patients in the Intensive Care Unit: The HEALiX™ Intubated Patient (IP) Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Device Ineffective
Safety Issues
Keywords: self-extubation
non-restraint device
removal of lines
Lead sponsor: Lancaster General Hospital
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group descriptive pilot study
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The current standard of care for limiting the movement of mechanically ventilated critical care patients is the use of physical wrist restraints, which are both ineffective in preventing removal of invasive and adjunct respiratory support devices and have a multitude of negative physical and psychological consequences for the patient. The objective of the proposed research is to test an innovative device designed to allow more freedom of movement of mechanically ventilated patients without bending of the arms, thereby preventing removal of adjunct mechanical ventilation devices and invasive monitoring equipment.


Eligibility criteria: Inclusion Criteria:

* speak English
* legally authorized representative must speak English
* admitted by one of the services presiding over the selected intensive care units
* mechanically ventilated receiving analgesic-sedating medications
* have soft wrist restraints applied as part of their care plan documented in the medical record to reduce the risk of unplanned removal of medical devices

Exclusion Criteria:

* pregnant women
* prisoners
* patients who are in a medically induced coma or in a comatose state (Glasgow Coma Scale \<8) for any reason

Primary outcomes:
measure: Unplanned removal of devices
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Ease of device use
timeFrame: up to 2 weeks
measure: Availability of device
timeFrame: up to 2 weeks
measure: Alternate device use
timeFrame: up to 2 weeks
measure: Ease of application
timeFrame: up to 1 week
measure: Acceptability of device
timeFrame: up to 1 week
measure: Education around device
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Lancaster General Health
state: Pennsylvania
Study officials:
affiliation: Penn Medicine Lancaster General Health
name: Lisa Caplan, DNP-C
role: PRINCIPAL_INVESTIGATOR
References: