louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05445427: Vagal Nerve Stimulation for Post COVID Fatigue
Official title: Outcomes of Treatment With Vagal Nerve Stimulation in Post-COVID Syndrome: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post COVID Syndrome
Fatigue
Headache
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 18
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 purpose of this study is to evaluate the impact of vagal nerve stimulation on patients with post COVID syndrome who have fatigue and headache.

Detailed description: Patients, after consenting, will perform questionnaires, have a blood samples taken, and undergo PET/CT scans of the brain. Patients will then be randomized to either receive vagal nerve stimulation, or continue standard clinical care. For those randomized to receive treatment, they will be given a device and asked to follow a specific regimen daily for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Presence of fatigue and post exertional malaise.
* Presence of headache
* Clinical diagnosis of post COVID syndrome.
* They have consented to participate in the study
* They have the ability to participate in all aspects of the study.

Exclusion Criteria:

* Pregnant.
* Prior adverse reaction to 14FDG.
* Active implantable medical device e.g. pacemaker, hearing aid implant
* Metallic device e.g. stent, orthopedic hardware in neck
* Using another electronic device at the same time e.g. TENS, mobile phone.
* Any other condition deemed exclusionary by the study principal investigator

Primary outcomes:
measure: Change in Post-COVID Functional Status Score
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in PROMIS Fatigue Scale T Score
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ryan T. Hurt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02972827: Monitoring Devices in Prediction of Fluid Responsiveness in Severe Sepsis and Septic Shock
Official title: Comparison of the Accuracy of Monitoring Devices in Prediction of Fluid Responsiveness in Severe Sepsis and Septic Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Sepsis
Septic Shock
Lead sponsor: Santa Barbara Cottage Hospital
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 38
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: Comparison of noninvasive cardiac output monitor (NICOM, Cheetah Medical) with Edwards FloTrac minimally-invasive cardiac output monitor in predicting fluid responsiveness in sepsis and septic shock.

Detailed description: Study will evaluate ability of passive leg raise test to predict fluid responsiveness in patients in septic shock, on vasopressors, using both the NICOM and FloTrac devices. An increase in CI, SVI, or Pulse Pressure of \>10% in response to the passive leg raise will be considered a positive passive leg raise test, and the same indicators will be considered a significant response to a fluid challenge with either crystalloids or colloids.Each device will be evaluated independently, but simultaneously.

Eligibility criteria: Inclusion Criteria:

* All adult patients with severe sepsis or septic shock, who have arterial catheter placed with FloTrac monitor, with or without a central venous catheter.

Exclusion Criteria:

* Declination of consent
* Known allergy to adhesive
* Pregnancy
* Contraindication to raising legs or head to 45 degrees for 3 minute intervals

Primary outcomes:
measure: Number of participants who have agreement or disagreement between passive leg raise response and subsequent intravenous fluid challenge
timeFrame: 15 minutes
Secondary outcomes:
measure: Decrease in vasopressor dose, in response to fluid therapy guided by passive leg raise response using NICOM or Flotrac devices
timeFrame: 48 hours
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
Study officials:
References:
Clinical trial NCT03637127: Acute Exposure of Simulated Hypoxia on Cognitive Function
Official title: Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: Simulated altitude
cognitive function
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Including a baseline assessment and assessments under simulated altitude and normoxia.
Primary purpose: PREVENTION

Brief summary: Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FiO2:15.1, equivalent to 2500m above sea level) on cognitive functions.

Detailed description: Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device.

During the exposure to simulated altitude (FiO2: 15.1%) of approximately 1 hour, the participants will perform cognitive function test .

The results will be compared under hypoxic and normal conditions.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (PAWP) ≤15 mmHg during right heart catheterization at the time of initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting partial oxygen pressure (PaO2) ≤7.3 kilopascal (kPA) corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, high-altitude pulmonary edema (HAPE), etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability
* Women who are pregnant or breast feeding

Primary outcomes:
measure: Cognitive Function test
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Respiratory Clinic, University Hospital of Zurich
Study officials:
affiliation: University of Zurich
name: Silvia Ulrich, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06751927: New Strategies to Enhance Smoking Cessation
Official title: Uptake of Varenicline and Strategies for Enhanced Engagement in Treatment for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-12-30
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study goal is to get feedback on ways researchers can communicate complex research findings on smoking cessation to better inform patients' decisions to use medication and/or quit smoking. This will help researchers and clinicians to provide effective, easy-to-implement treatments designed to address tobacco-related health disparities in Black and other racial/ethnic subgroups. It will also help improve health literacy to change misperceptions and mistrust on uptake of varenicline and other medication for quitting smoking. A professionally made video will explain research findings relevant for varenicline's mechanisms and outcomes relative to other treatment options.

There are 2 parts to this study:

* Part 1: Focus Group to help develop the educational tool intervention
* Part 2: Randomized portion of study. In this part of the study, participants will be randomized (like flip of coin) to take part in receive the experimental educational intervention or usual methods to help stop smoking. Participants in either arm can choose to receive varenicline and it will be provided as part of study.


Eligibility criteria: Inclusion Criteria:

* Patients must smoke at least 10 cigarettes/day and do not currently use a smoking cessation medication.
* Ages 18-75.
* Agree to complete surveys and measures within study.
* Ability to understand English and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who are receiving any other smoking cessation medications.
* Patients who are pregnant and/or lactating.
* Patients with psychiatric contraindications that can prevent adherence to protocol or use of intervention tools in study. For inclusivity on trial, psychiatric contraindications and ability for patient to participate in trial will be assessed on an individual basis by study investigator.
* Patients who have a contraindication with varenicline.

Primary outcomes:
measure: Acceptability of the experimental video intervention
timeFrame: 24 weeks
measure: Determine whether provision of technology access and support will improve program attendance and smoking outcomes
timeFrame: 24 weeks
measure: Trial feasibility
timeFrame: End of study recruitment (6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Andrea C. King
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03187327: Feasibility of Opportunistic Salpingectomy at the Time of Vaginal Hysterectomy for Benign Pathology
Official title: Feasibility of Opportunistic Salpingectomy at the Time of Vaginal Hysterectomy for Benign Pathology and Evaluation of Occult Tubal Lesions Prevalence: Preliminary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Salpingectomy
Hysterectomy
Keywords: prophylactic salpingectomy
vaginal hysterectomy
p53 expression
ovarian cancers
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent vaginal hysterectomy with salpingectomy or salpingo-oophorectomy

Brief summary: In this prospective study, patients who underwent vaginal hysterectomy with salpingectomy or salpingo-oophorectomy were included. The objective of this study is to assess the feasibility of prophylactic salpingectomy during vaginal hysterectomy for benign pathology and the prevalence of occult tubal lesions. The hypothesis is that prophylactic salpingectomy during vaginal hysterectomy for benign pathology present a low failure rate and it makes it possible to avoid the appearance of a certain number of ovarian cancers. The prevalence of bilateral salpingectomy with or without ovariectomy and the prevalence of histopathological and immunohistochemical (p53 expression) abnormalities were evaluated.


Eligibility criteria: Inclusion Criteria:

* patients who underwent vaginal hysterectomy for benign pathology with salpingectomy or salpingo-oophorectomy

Primary outcomes:
measure: Success rate of the surgical technique
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
affiliation: Hospices Civils de Lyon
name: Gautier CHENE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06473727: Evaluation of the Initial Color Match of Different Single-shade Composites
Official title: Evaluation of the Initial Color Match of Anterior Non-caries Cervical Lesions Restorated With Different Single-shade Resin Composites: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Diseases
Keywords: blending
color match
composite resin
esthetics
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the initial colour match of anterior non-carious cervical lesions restored with different single-shade resin composites, namely Omnichroma (Tokuyama) and Charisma Topaz One (Kulzer).

Detailed description: Colour selection for composite restorations is a challenging process influenced by a number of environmental and operator factors. The polychromatic structure of natural teeth presents a challenge to shade selection. Consequently, the prevailing trend towards simplification of shade matching has led to the emergence of single-shade universal composites. Single-shade universal composites are able to replicate the natural colour of teeth by capturing the structural colour based on the size of the filler particles. Unlike other materials, it does not require the use of additional dyes or pigments. The blending, colour induction and colour assimilation effects of resin composites are collectively referred to as the chameleon effect. This phenomenon allows resin-based restorative materials to achieve a shade that closely resembles the colour of the surrounding tooth structure. The intelligent monochromatic composite makes shade selection easier for the clinician and provides a quick and easy way to create aesthetic restorations. Its distinctive character reduces confusion and potentially saves time in the clinic. However, the effectiveness of this material in matching different shades of natural teeth remains uncertain, and there is a paucity of clinical evidence on the efficacy of its colour-matching capabilities in dental restorations.

Eligibility criteria: Inclusion Criteria:

* Maintain satisfactory oral hygiene
* Have healthy gingival tissues
* Presence of an anterior non-carious cervical lesion approximately 5 m wide

Exclusion Criteria:

* Presence of caries
* Signs of fistula
* Pulp exposure
* Periodontal tissue swelling
* Abnormal tooth mobility

Primary outcomes:
measure: Color assesment
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Faculty of Dentistry, Erciyes University
Study officials:
affiliation: TC Erciyes University
name: Ayse Nur Dogan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03522727: Using Implementation Intentions to Self-incentivise Weight-loss
Official title: Using Implementation Intentions to Self-incentivise Weight-loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the present research is to test the effect of helping people to reward themselves when they have successfully lost weight and the impact this will have on subsequent weight. Each participant will be randomly allocated to one of four conditions. The trial requires 200 participants to perform a fully powered statistical analysis. The four conditions are: (1) a control condition, (2) intervention 1 (form a single self-incentivising implementation intention from a drop-down menu), (3) intervention 2 (form multiple self-incentivising implementation intentions from a drop-down menu), or (4) intervention 3 (asked to form a single self-incentivising implementation intention of their own devising). The main outcome measure will be BMI, which will be self-reported.


Eligibility criteria: Inclusion Criteria:

* Aged 18+

Exclusion Criteria:

* Unable or unwilling to complete questionnaire

Primary outcomes:
measure: Body Mass Index
timeFrame: 4 weeks
measure: Actual Use of Self-Rewards
timeFrame: 4 weeks
Secondary outcomes:
measure: Capabilities, opportunities and motivations
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Online study
city: Manchester
country: United Kingdom
facility: University of Manchester
Study officials:
affiliation: University of Manchester
name: Christopher Armitage, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03171727: Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction
Official title: Post-TIPS Short-term Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Portal Hypertension
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transjugular intrahepatic portosystemic shunt (TIPS) dysfunction is defined as a loss of decompression of the portal venous system due to occlusion or stenosis of the TIPS. Occlusion of the TIPS can either be due to thrombosis or hyperplasia of the intima. Thrombosis of the TIPS usually occurs early and can happen within 24 hours of TIPS creation. The frequency of this complication is on the order of 10%-15% when bare stents are used. Post-TIPS short-term low molecular weight heparin (LMWH) was used to prevent the early thrombosis formation. Weather post-TIPS LMWH was necessary when polytetrafluoroethylene-covered stent was used during TIPS creation was not answered. The present study was designed to evaluate the effect of short-term use of LMWH on early TIPS dysfunction.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of liver cirrhosis
2. Technical success of TIPS was achieved.

Exclusion Criteria:

1. Non-cirrhotic portal hypertension
2. Portal vein thrombosis
3. Budd-Chiari syndrome
4. Pregnancy
5. Contradictions to anticoagulation therapy

Primary outcomes:
measure: TIPS patency rate
timeFrame: one year
Secondary outcomes:
measure: LMWH-related complication
timeFrame: one month
measure: Mortality rate
timeFrame: one year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West china Hospital
Study officials:
affiliation: Sichuan University
name: xuefeng luo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02165527: Evaluation of Bone Length Measurement
Official title: Evaluation of Bone Length Measurement Using Lunar iDXA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Calcification
Osteoporosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if Lunar iXDA scanning with the use of a computer software program can make accurate measurements of the length of leg bones compared to conventional x-rays.

Detailed description: The investigators would like to see how well the calculation of bone length using Lunar iDxa compares to conventional x-ray since the Lunar iXDA exposed patients to less radiation than conventional x-rays.

Eligibility criteria: Inclusion Criteria:

* Age 18 yrs. of age or older
* Have recent x-rays of lower extremity
* Are at least 3 feet 7 inches tall and not taller than 6 feet 7 inches.

Exclusion Criteria:

* Are unwilling to read and sign the consent
* Are pregnant or if subject has not had a negative pregnancy test just prior to the iXDA scan
* Have severe deformities of your legs or back
* Unable to lay on the scanning table for the scan

Primary outcomes:
measure: Leg (Femur and Tibia) bone length measurement in centimeters using iDXA
timeFrame: scan time is 8 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Yebin Jiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01005927: Fructooligosaccharide and Calcium Absorption in Adolescent Girls
Official title: Fructooligosaccharide and Calcium Absorption in Adolescent Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoporosis
Keywords: Calcium
Bone and Bones
Girls
Bone Mineralization
Fiber
Fructooligosaccharide
Female
Healthy
Adolescents
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Abbott Nutrition
name: GTC Nutrition
First posted: 2009-11-01
Enrollment: 26
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Fructooligosaccharides (FOS) are believed to have positive effects on calcium absorption and bone accrual during growth. This study aims to see whether the addition of fiber in the form of FOS to a calcium-containing beverage will increase calcium absorption. During two clinical visits, participants will receive a beverage containing a small amount of calcium, supplemented with either no dietary fiber or a small amount of fiber. Height, weight, bone density and geometry, calcium absorption, and physical fitness will be measured. The effects of this fiber intervention may provide support for improving bone health with minimal fiber supplementation.


Eligibility criteria: Inclusion Criteria:

* Female
* Calcium intake of 900-1300 mg/d
* Generally healthy

Exclusion Criteria:

* Male
* BMI \> 90th percentile for age
* Takes medication that influences calcium metabolism
* Any disorder of calcium or bone homeostasis (hypercalcemia, Paget's Disease)
* Smoking, illegal drug consumption
* Any gastrointestinal disease (Crohn's Disease, Celiac Disease, Inflammatory Bowel Disease)

Primary outcomes:
measure: Fractional Calcium Absorption
timeFrame: 24 h urine and 3 h blood
Secondary outcomes:
measure: Bone density and geometry measured with peripheral quantitative computed tomography (pQCT)
timeFrame: Initial visit
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Connie M Weaver, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Purdue University
name: Berdine R Martin, PhD
role: STUDY_DIRECTOR
References: