louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03683238: Nutritional Status and Hidradenitis Suppurativa (Acne Inversa)
Official title: Role of Nutritionist in the Multidisciplinary Approach of Hidradenitis Suppurativa (Acne Inversa)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hidradenitis Suppurativa
Mediterranean Diet
Body Composition
Vitamin D Deficiency
Trimethylamine N-oxide (TMAO)
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consisted of 82 participants, 41 patients with HS and 41 healthy subjects as control group.

Brief summary: Hidradenitis suppurativa (HS) is a chronic inflammatory, debilitating skin disorder. The exacerbating factors of HS include nutrition and adiposity. The objective of this study was to investigate the relationships between body composition and the adherence to the Mediterranean diet (MD) with the severity of HS in a sample of naïve-treatment patients with HS. In the wake of this evidence, in the study to investigate the relationships between nutritional status, the adherence to the MD, body composition, and the severity of HS in a sample of naïve-treatment patients with HS compared to control group matched for sex, age, and body weight.


Eligibility criteria: Inclusion Criteria:

* healthy subjects of both gender
* treatment-naïve patients
* had HS diagnosed ≥6 months before study initiation wash out therapy for at least 3 months

Exclusion Criteria:

* occasional or current of use of drugs for HS, including topical antibiotics and systemic treatments (such as clindamycin-rifampicin, tetracycline, Rifampicin-moxifloxacin-metronidazole, ertapenem, acitretin, cyclosporine A, dapsone, isotretinoin, biologics;
* hypocaloric diet in the last three months or specific nutritional regimens;
* vitamin/mineral or antioxidant supplementation;
* occasional or current of use of drugs that could influence fluid balance, including non-steroidal anti-inflammatory drugs, hormone replacement therapy.

Primary outcomes:
measure: Adherence to Mediterranean Diet by Predimed Questionnaire
timeFrame: April 2015 to April 2018
measure: Phase angle
timeFrame: April 2015 to April 2018
measure: Trimethylamine N-oxide plasma levels
timeFrame: April 2015 to April 2018
Secondary outcomes:
measure: Vitamin D
timeFrame: April 2015 to April 2018
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06092138: Edge Computing Platform for Spine Health Risk Management Based on IoT Technology
Official title: Edge Computing Platform for Spine Health Risk Management Based on IoT Technology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Disc Herniation
Cervical Spinal Stenosis
Ossification of Posterior Longitudinal Ligament
Neckbrace Device
Keywords: Rehabilitation
Neckbrace Device
Cervical Diesase
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project proposes to monitor the spinal posture of a person at rest and in motion in real time through a sensor device that contains spinal health monitoring as its core. By calibrating the five core planes on the spine and using AI algorithms to train the model, the relationship between the core plane data and spine health is established.This project will output medical-grade and consumer-grade wearable spine healthcare and monitoring products, establish an interactive platform to connect the wearer, the data terminal and the professional medical team, so that patients can easily get professional health advice and reminders during home healthcare and rehabilitation; and through the collection of spine health data, establish a national spine health database.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 60 years.
* Degenerative diseases of the cervical spine such as cervical disc herniation, cervical stenosis, ossification of the posterior longitudinal ligament, etc., but surgery is not considered for the time being.
* Available for clinical follow-up and agree to long-term clinical follow-up and sign informed consent.

Exclusion Criteria:

* Age less than 18 years or more than 60 years.
* Life expectancy less than 1 year.
* Suffering from severe dementia (MMSE score less than 18).
* Suffering from other serious medical conditions.
* Inability to sign informed consent.

Primary outcomes:
measure: visual analogue scale
timeFrame: Enrollment baseline，the first month, the second month, the third month
measure: neck disability index
timeFrame: Enrollment baseline，the first month, the second month, the third month
measure: quality of life short form 12
timeFrame: Enrollment baseline，the first month, the second month, the third month
Secondary outcomes:
measure: Change in muscle strength (grade)
timeFrame: Enrollment baseline, the third month
measure: Change in muscle tone (grade)
timeFrame: Enrollment baseline, the third month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Edge Computing Platform for Spine Health Risk Management
state: Beijing
Study officials:
References:
Clinical trial NCT04036838: ARJ C13 Urea Breath Test System
Official title: ARJ C13 Urea Breath Test System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: H. Pylori Infection
Lead sponsor: ARJ Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-30
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market.

Detailed description: An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market. Predicate devices include: Histology, Culture, RUT, and other 13C Breath Tests.

Eligibility criteria: Inclusion Criteria:

* Male or female at least 18 years of age at the time of visit
* Patients who are experiencing the effects of gastritis
* Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study

Exclusion Criteria:

* Pregnant or lactating women.
* Study subjects currently taking antibiotics
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
* Fasting required one hour prior to testing
* Study subjects shall not consume the following items prior to the test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to stimulate the effect of ketone production that may result from some diets), Alcohol

Primary outcomes:
measure: Overall Percent Agreement
timeFrame: 2 Visits
Secondary outcomes:
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: American Gastroenterology and Hepatology
state: Florida
city: Clermont
country: United States
facility: South Lake Gastrenology
state: Florida
city: Largo
country: United States
facility: Florida Center for Gastroenterology
state: Florida
city: Tampa
country: United States
facility: Habana Medical Center
state: Florida
city: Tampa
country: United States
facility: Whitaker, Weintraub & Grizzard
state: Florida
city: Trinity
country: United States
facility: Bay Area Gastroenterology Associates
state: Florida
Study officials:
References:
Clinical trial NCT02596438: Thousand Asian American Study
Official title: Thousand Asian American Study (TAAS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 1076
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asian Americans residing in Sacramento, CA who are 18 years of age and older.

Brief summary: The "Thousand Asian American Study" or "TAAS" aims to test 2,000 foreign-born and children of foreign born Asian Americans residing in Sacramento county residents for HBV and (2) counsel at least 90% of those whose screening results are positive for HBV.

Detailed description: The "Thousand Asian American Study" or "TAAS" aims to better understand the factors associated with testing for hepatitis B viral (HBV) testing among foreign-born Asian and African adult residents of Sacramento county, characteristics of those infected with HBV, and the efficacy of follow-up and linkage to care for those infected with HBV, and develop a research platform for future studies. Thus, what the investigators want to do is 1) test 2000 foreign-born Sacramento county residents for HBV and (2) counsel at least 90% of those whose screening results are positive for HBV. The investigators want to better characterize factors associated with HBV testing and factors that may differentiate those determined to be free of infection, infected with HBV, and those with resulting primary liver cancer.

Eligibility criteria: Inclusion Criteria:

* All foreign-born Asians and any foreign-born adults born in CDC-defined high to intermediate endemic areas residing in Sacramento County, California.

Exclusion Criteria:

* Individuals who have been previously serologically tested for Hepatitis B (self-reported).

Primary outcomes:
measure: Number of patients or adult children of patients born in Hepatitis B endemic countries (rate of 2% or higher) getting screened for hepatitis B.
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients that are hepatitis B positive that receive counseling regarding their infection.
timeFrame: 1 year
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Comprehensive Cancer Center
state: California
Study officials:
affiliation: UC Davis Comprehensive Cancer Center
name: Moon S Chen Jr., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stewart SL, Dang JH, Torok NJ, Chen MS Jr. Patterns and co-occurrence of risk factors for hepatocellular carcinoma in four Asian American communities: a cross-sectional study. BMJ Open. 2019 Jun 28;9(6):e026409. doi: 10.1136/bmjopen-2018-026409.
Clinical trial NCT02940938: Study on Changes of Pulse Oximeter Plethysmographic Amplitude Induced by Respiration in Pediatric Patients
Official title: Study on Changes of Pulse Oximeter Plethysmographic Amplitude Induced by Respiration in Pediatric Patients: the Effect of Contacting Force
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Children Under General Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 35
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the variations of respiratory changes in pulse oximeter plethysmographic amplitude (delta POP) according to different contact forces between finger and sensor of pulse oximeter. During general anesthesia without surgical stimuli, pulse oximeter sensor is applied with serial contact force, from 0 to maximal 1.5N (increased by 0.2N) and POP waveform is obtained for 60 seconds. Delta POP will be calculated and compared.


Eligibility criteria: Inclusion Criteria:

* children who are aged between 2 and 5 years
* no cardiopulmonary and vascular diseases
* obtained written informed consent from their guardians
* no hemodynamic instability from massive bleeding

Exclusion Criteria:

* significant cardiopulmonary or vascular disease
* significant hemodynamic instability due to massive bleeding etc.
* cyanotic patients

Primary outcomes:
measure: Respiratory changes in pulse oximeter plethysmographic amplitude measured
timeFrame: about 3 minutes after anesthetic induction without surgical stimuli
Secondary outcomes:
measure: Amplitude of pulse oximeter plethysmography
timeFrame: about 3 minutes after anesthetic induction without surgical stimuli
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongro Gu
Study officials:
References:
Clinical trial NCT03895138: Trial to Investigate the in Silico Optimization of Insulin Treatments
Official title: A Feasibility Randomized Control Trial to Investigate the in Silico Optimization of Insulin Treatments
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Bypass
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2019-03-29
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects with CABG or open heart valve surgery will be enrolled in the study. They will be randomized to receive one of the following treatments:

1. Standard Glucommander Protocol (SGP)
2. Optimized Glucommander (OGM)
Primary purpose: OTHER

Brief summary: The primary objective of this study is to assess the performance of an in silico designed alternative protocol for control of stress hyperglycemia of inpatients treated for Coronary Artery Bypass Graft (CABG) or valve replacement surgery in the University of Virginia cardiothoracic ICU.

Detailed description: The hypothesis of the study is that settings for the Glucommander protocol can be optimized in silico to achieve statistically improved low blood glucose index (LBGI) within the subpopulation of CABG and valve replacement patients who both receive Glucommander-based insulin therapy and meet Manufacturer's guidelines for starting with an initial multiplier value of .052, without risking clinically significant increase in exposure to hyperglycemia.

Eligibility criteria: Inclusion Criteria:

1. Patients admitted for CABG and/or open heart valve surgery
2. Must have a 0.05 initial multiplier setting for the Glucommander based on the manufacturers recommendations
3. Age of 40-75, inclusive

Exclusion Criteria:

1. History of severe hypoglycemia within six months of hospital admission
2. Currently undergoing dialysis or renal replacement therapy
3. Women of childbearing potential
4. Patients with endocarditis needing valve replacement
5. Participation in another clinical trial at the time of screening.

Primary outcomes:
measure: Exposure to risk of hypoglycemia
timeFrame: 24 hours of post-operative hospital stay
Secondary outcomes:
measure: Exposure to risk of hypoglycemia
timeFrame: 48 hours of post-operative hospital stay
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Vrginia
state: Virginia
Study officials:
References:
Clinical trial NCT02352038: Randomized Controlled Trial of a Novel Laser-aided Orthodontic-periodontal Treatment Strategy
Official title: Randomized Controlled Trial of a Novel Laser-aided Orthodontic-periodontal Treatment Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Disease
Keywords: malocclusion
low-level laser therapy
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the effects of low-level laser therapy (LLLT) in patients with periodontitis during orthodontic-periodontal treatment for 12 months on the following aspects: (1) Effects on periodontal status; (2) Effects on alveolar bone remodeling; (3) Effects on cervical dentin sensitivity; (4) Effects on pain and quality of life.

To eliminate any bias, the investigators will initially hypothesize that there is no difference in periodontal status, jawbone remodeling, tooth sensitivity, pain and quality of life in patients having teeth with chronic periodontitis and receiving LLLT with orthodontic treatment versus teeth undergoing orthodontic treatment without incorporation of LLLT.

Detailed description: On the basis of the investigators' pilot study results, 35 patients with chronic periodontitis will be recruited and initially treated for inflammation. Using a randomized split-mouth design,the teeth in experimental (laser) group will receive LLLT while the teeth in the control (placebo) group will receive no laser treatment. The effects of LLLT in orthodontic-periodontal treatment on periodontal inflammation control, jawbone remodeling, reduction of tooth sensitivity, pain relief and quality of life will be investigated.

Eligibility criteria: Inclusion Criteria:

1. Systemically health (with special regard to disease affecting tissue repair);
2. No medications required for periodontal therapy and no use of any antibiotic and/or anti-inflammatory medication in the preceding month;
3. Chronic periodontitis with at least two pairs (clinically matched) displaced single-rooted teeth (each pair of teeth is in the same arch but in two contralateral hemi-arches respectively belonging to the same tooth typology) having at least one site probing depth of 5 mm or more, interproximal attachment loss of 3 mm or more, and radiographic signs of alveolar bone loss.
4. Periodontal status confirmed by periodontal evaluation remains stable for at least 6 months after complete periodontal treatment.

Exclusion Criteria:

1. smoking;
2. pregnancy;
3. under orthodontic treatment.

Primary outcomes:
measure: inflammatory cytokine levels in the gingival cervical fluid
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Prince Philip Dental Hospital
Study officials:
affiliation: The University of Hong Kong
name: Yanqi Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05967208: Confidential Social Network Referrals for HIV Testing
Official title: Confidential Social Network Referrals for HIV Testing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Duke University
name: Kilimanjaro Christian Medical Centre, Tanzania
First posted: 2023-08-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Despite worldwide efforts to promote HIV testing, rates of testing remain low. The purpose of this study is to evaluate the acceptability, efficacy, and cost-effectiveness of confidential SMS-based social network referrals for HIV testing as a means of reaching high-risk individuals and prompting them to test for HIV. To accomplish this purpose, the study has 5 specific aims:

Aim 1 will conduct qualitative, formative work to identify desirable provider- and client-side characteristics of a confidential SMS-based HIV testing referral system.

Aim 2 will adapt an existing mHealth system (mParis) to add CONSORT functionality.

Aim 3 will pilot-test the CONSORT system to collect preliminary data on the system's acceptability, performance, and potential efficacy.

Aim 4 will evaluate the acceptability and efficacy of CONSORT in a randomized controlled trial.

Aim 5 will evaluate the incremental cost-effectiveness of CONSORT vs. other referral options.

If CONSORT is shown to be acceptable, effective, and cost-effective, such mobile-phone supported, chain-referral methods could greatly improve the cost-effectiveness of HIV testing efforts.

Detailed description: No additional detail available

Eligibility criteria: Inclusion criteria:

* at least 18 years old
* live, work, or regularly receive care in Moshi, Tanzania
* literate

Exclusion criteria:

* under age 18 years
* does not live, work, or regularly receive care in Moshi, Tanzania
* illiterate

Primary outcomes:
measure: Uptake of HIV testing
timeFrame: Within 30 days of the time of the testing offer
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of South Carolina
name: Jan Ostermann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Nathan Thielman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kilimanjaro Christian Medical Centre, Tanzania
name: Bernard Njau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ostermann J, Njau B, Masaki M, Mtuy T, Itemba D, Hobbie A, Yelverton V, Moore S, Yamanis T, Thielman NM. Feasibility, Acceptability, and Potential Cost-Effectiveness of a Novel Mobile Phone Intervention to Promote Human Immunodeficiency Virus Testing Within Social Networks in Tanzania. Sex Transm Dis. 2022 Nov 1;49(11):778-781. doi: 10.1097/OLQ.0000000000001611. Epub 2022 Jan 29.