louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04070534: PALS for Pap Smear Follow up
Official title: Utilization Of A Web-Based Platform (Patient Activated Learning System- PALS) To Improve Knowledge And Follow-Up Among Women With Abnormal Cervical Cancer Screening (PALS)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the researchers will utilize information gained from patient interviews about their knowledge of the cervical cancer screening and treatment process, and perceived barriers surrounding appropriate follow up, to create content for the intervention.

Detailed description: The overall goal of this research is to develop and test an intervention designed to improve knowledge and follow up among underserved women with abnormal pap smears. The researchers will use a unique web-based platform, the Patient Activated Learning System (PALS), which provides engaging and informative video and text designed to improve patient knowledge specifically among underserved populations. Twenty diverse patients with abnormal pap smears will be recruited from the Women's Health colposcopy clinic for initial qualitative interviews. Forty patients from the same population will then be engaged in a pre-post pilot to examine feasibility, acceptability, and impact of modules on improving knowledge.

Eligibility criteria: Inclusion Criteria:

* All Women 21-65 years with diagnosis of abnormal pap smear presenting to Women's Health Colposcopy Clinic at WCMC
* Access to a smartphone
* English or Spanish Speaking

Exclusion Criteria:

* Pregnant women
* Non-English or Spanish speakers

Primary outcomes:
measure: Reusable knowledge objects (RKOs)
timeFrame: Month 1-2
measure: Knowledge change
timeFrame: Month 3-4
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Prebyterian Hospital Weill Cornell
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Eloise Chapman-Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03434834: OCT Pilot in Esophagus
Official title: Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An Optical Coherence Tomography (OCT) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett Esophagus
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: National Cancer Institute (NCI)
First posted: 2018-02-15
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot study to test a newly developed optical coherence tomography (OCT) device to determine 1) whether adequate tissue contact can be attained to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or Barrett's Esophagus (BE) epithelium.


Eligibility criteria: Inclusion Criteria:

1. Presenting to University of North Carolina (UNC) for routine care upper endoscopy
2. Meet one of the following criteria:

   1. Presenting to UNC for upper endoscopy of GI conditions without esophageal symptomology for with no history of gastroesophageal reflux disease (GERD) or other esophageal condition affecting the epithelium (asymptomatic controls), OR,
   2. History of dysplastic or non-dysplastic Barrett's Esophagus with prague criteria C1+ or M3+
3. Aged 18 to 80
4. Able to read, comprehend, and understand the informed consent document.

Exclusion Criteria:

1. Prior esophageal surgery (uncomplicated nissen fundoplication OK)
2. Pregnant women
3. Unable to provide written informed consent

Primary outcomes:
measure: Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa
timeFrame: at baseline
measure: Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa
timeFrame: at baseline
Secondary outcomes:
measure: Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image
timeFrame: at baseline
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: Professor
name: Adam Wax, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04065334: Exercise Training as Medicine for Substance Use Disorder Patients
Official title: Effects of Low- Versus High Dose High Intensity Interval Training and Strength Training on Physical Health in Substance Use Disorder Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: Resistance training
Endurance training
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2019-08-22
Enrollment: 171
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: This study compares the effects of high dose and low dose, high intensity, endurance training and strength training in substance use disorder patients. The hypothesis is that the increase in endurance (measured as maximal oxygen uptake) and strength (measured as maximal strength) will be similar in both the high dose and low dose training groups after 24 training sessions over eight weeks. The rationale for this assumption is based on the patient groups poor physical capacity, supporting that a lesser physical workload is needed to achieve a substantial increase in physical capacity. The practical implication could be higher training attendance, because it is likely easier to motivate the patient group when they only have to perform half the workload. It is paramount for this patient group to increase their physical capacity and consequently augment their physical health status since they are in a high-risk group for developing life-threatening lifestyle related diseases.


Eligibility criteria: Inclusion Criteria:

* Being an inpatient at the clinic
* Free of known cardiovascular disease, pulmonary disease and cancer

Exclusion Criteria:

* Not able to perform a maximal treadmill test
* Not able to perform a maximal strength test in hack squat

Primary outcomes:
measure: change in oxygen uptake
timeFrame: baseline to 8 weeks
measure: change in leg muscular strength
timeFrame: baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Klinikk for rus- og avhengighetsmedisin, St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Kristin Smedsrud
role: STUDY_DIRECTOR
References:
citation: Loe H, Mosti MP, Wisloff U, Haberstroh C, Flemmen G. Cardiopulmonary and muscular effects of different doses of high-intensity physical training in substance use disorder patients: study protocol for a block allocated controlled endurance and strength training trial in an inpatient setting. BMJ Open. 2022 Sep 27;12(9):e061014. doi: 10.1136/bmjopen-2022-061014.
Clinical trial NCT05594134: Efficacy of an Automatic Toothbrush
Official title: Efficacy of an Automatic Toothbrush With Nylon Bristles in Removing Dental Plaque: a Randomized Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this study is to compare the efficacy in terms of bacterial plaque removal, in a single use, of a new Y-shaped automatic electric toothbrush with nylon bristles, compared with the electric toothbrush of similar shape but with silicone bristles, with the manual toothbrush, and with a negative control (no brushing) in a group of volunteer students.

Primary endpoint: difference in "full mouth plaque score" between before and after brushing.

Secondary endpoint: sensation of "clean mouth" assessed on VAS scale from 0 to 10 where 0 indicates no sensation of clean mouth and 10 maximum sensation of clean mouth.

Single-center, randomized, controlled, superiority, cross-over, examiner-blinded study with 5 treatments (Y-shaped electric toothbrush with nylon bristles, similarly shaped electric toothbrush with silicone bristles, manual brushing for 45 seconds, manual brushing for 2 minutes, no brushing), carried out in a single session and spaced one week apart.


Eligibility criteria: Inclusion Criteria:

* Absence of fixed orthodontic appliances
* Presence of at least 20 teeth
* Full mouth plaque score greater than 40%
* Having provided signed and dated informed consent.

Exclusion Criteria:

* Subjects with manual inability to perform normal oral hygiene maneuvers
* Subjects allergic to silicone or nylon.

Primary outcomes:
measure: Change in full mouth plaque score
timeFrame: 5 minutes
Secondary outcomes:
measure: Perception of "clean mouth"
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Florence
country: Italy
facility: School of Dentistry, The University of Florence
Study officials:
References:
Clinical trial NCT05497934: The Effects of Glycerol as an Optical Clearing Agent for Visualization of the Middle Ear
Official title: The Effects of Glycerol as an Optical Clearing Agent for Visualization of the Middle Ear
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Tympanosclerosis
Thickened Ears
Healthy
Surgery
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2022-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will undergo OCT and conventional endoscopic imaging before topical application of glycerol to the tympanic membrane, after topical application of glycerol to the tympanic membrane and after rinsing the tympanic membrane with saline.
Primary purpose: DIAGNOSTIC

Brief summary: This study will examine the improvement in middle ear optical coherence tomography imaging from the topical application of glycerol to the tympanic membrane in normal, opaque and post-operative ears

Detailed description: This study will explore whether the utility of Optical Coherence Tomography (OCT) in otology patients can be enhanced through the application of topical glycerol as an optical clearing agent in patients with normal, opaque and post operative tympanic membranes. In each group of subjects, a comparison will be made between OCT images obtained before and after the topical application of glycerol to the tympanic membrane and following washout with saline. Images will also be assessed for their diagnostic utility as determined by the visibility of key structures and the change in middle ear mobility caused by glycerol absorption in the tympanic membrane.

Eligibility criteria: Inclusion Criteria:

* Thickened tympanic membrane (e.g. due to fibrosis) x10
* Tympanosclerosis of the tympanic membrane x10
* History of middle ear surgery with partial or total ossicular replacement prosthesis and cartilage tympanoplasty x10
* History of cartilage tympanoplasty without prosthesis implantation x10
* Normal tympanic membrane without history of middle ear disease x10

Exclusion Criteria:

* Narrow or stenotic external auditory canal that prevents visualization of the tympanic membrane
* Mobility disorder that prevents patient from remaining still during imaging
* Perforation of the tympanic membrane
* Open sores or infections of the external auditory canal

Primary outcomes:
measure: Change in optical attenuation rate of the tympanic membrane
timeFrame: 20 minutes
Secondary outcomes:
measure: Change in acoustic mobility of the umbo
timeFrame: 20 minutes
measure: Change in B-mode signal-to-noise ratio of the cochlear promontorium
timeFrame: 20 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Nova Scotia Health Authority
name: David P Morris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04918134: Investigation on Diagnosis and Treatment of Helicobacter Pylori Infection by Gastroenterologists in Shandong Province
Official title: Investigation on Diagnosis and Treatment of Helicobacter Pylori Infection by Gastroenterologists in Shandong Province
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori Infection
Keywords: questionnaire
Helicobacter Pylori Infection
cross-sectional survey
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Stratified sampling was carried out from all the secondary and tertiary general hospitals in Shandong province, and 120 hospitals were selected.Exclude those without gastroenterology department and those that refused to sign the informed consent, and all gastroenterologists in the hospitals were investigated.

Brief summary: Helicobacter pylori can lead to a variety of digestive system diseases.The eradication of Helicobacter pylori plays an importment role for the treatment of gastrointestinal ulcer and prevention of gastric cancer .Compared with other countries and regions in the world, the infection rate of Helicobacter pylori in China can reach more than 50%. The non-standard diagnosis and treatment of Helicobacter pylori greatly reduces its eradication rate and increases its drug resistance.Therefore, it is very important to strengthen the standardization of diagnosis and treatment to improve the eradication rate.

The purpose of this study is to investigate the diagnosis and treatment status of Helicobacter pylori among gastroenterologists in general hospitals in Shandong Province.It can help us to understand the actual situation of diagnosis and treatment of Helicobacter pylori in hospitals at all levels, and to provide targeted diagnosis and treatment training for doctors.


Eligibility criteria: Inclusion Criteria:

* All the gastroenterologists in secondary and tertiary general hospitals of Shandong province

Exclusion Criteria:

* A hospital that does not include gastroenterology
* Hospitals and gastroenterologists that refuse to sign informed consent

Primary outcomes:
measure: the results of the questionnaires
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hosipital
state: Shandong
Study officials:
References:
Clinical trial NCT01573234: Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions
Official title: Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wounds and Injuries
Abrasion
Cut Injuries
Keywords: MySkin patch
Hydrogel bandage
Occlusive dressing
Lead sponsor: Associazione Infermieristica per lo studio delle Lesioni Cutanee
Sponsor class: OTHER
Collaborators: name: Artsana S.p.a.
First posted: 2012-04-09
Enrollment: 180
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: Evaluation of clinical efficacy of My Skin (hydrogel and polyurethane film) plus best practice clinical care in subjects with cut injuries and abrasions with particular regard to: Wound healing (complete reepithelialization) and patient's pain.

In the context of the study will be collected secondary outcomes related to type of lesion and its clinical evolution through the analysis of the items in the scale of the Pressure Sore Status Tool(PSST).


Eligibility criteria: Inclusion Criteria:

* Presence of at least an injury cut or abrasion (even if sutured)covered by a dressing of 10x8 cm (80 cm2)
* Injury treated with conventional dressings type gauze and patch
* Patients assisted at the emergency care, or at the outpatient
* Extension of the lesion less than 80 cm2 (including dressings in cm10x8cm)
* Patient age greater than or equal to 18 years
* Patients who have given consent to enrollment in the trial and the processing of personal data
* Patient / lesion that has already been recruited in the study or who have previously passed a period of 10 days (wash-out) of "no treatment" according to the research protocol

Exclusion Criteria:

* A end-stage of disease
* Subjected systemic corticosteroid therapy / radiotherapy / immunosuppressive therapy
* Suspected or known allergic diathesis to the product of medication
* Subjects that do not give consent to data processing
* Dry lesion with necrosis or eschar
* Presence of both local and systemic infection or inflammation
* Injuries that to the decision of the provider of care, needs a targeted local treatment other than as provided for in the Protocol
* Patient / lesion that has already been previously recruited into the study, before a period of 10 days (wash-out) of suspension from the same research protocol

Primary outcomes:
measure: Wound healing
timeFrame: 1 month
measure: Patient's pain
timeFrame: 1 month
Secondary outcomes:
measure: Clinical evaluation of the lesion scores for each visit
timeFrame: 1 month
measure: The presence / absence of infection for each visit
timeFrame: 1 month
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Ospedale Bellaria - UOC Dermatologia
Study officials:
affiliation: Associazione Infermieristica per lo studio delle Lesioni Cutanee
name: Tommaso Bianchi
role: STUDY_DIRECTOR
References:
Clinical trial NCT00405834: A Pilot Study of the Envision® Surface
Official title: A Pilot Study of the Envision® Surface in a Patient Population at High Risk for or Who Have Pressure Ulcers: Evaluation of Pressure Ulcer Incidence, Changes in Existing Pressure Ulcers, Clinical Staff Satisfaction and Patient Comfort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Ulcers
Keywords: Pressure Ulcers
Lead sponsor: Hill-Rom
Sponsor class: INDUSTRY
First posted: 2006-11-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This study is to evaluate the clinical safety and effectiveness of the Envision® surface.

Detailed description: This study is to evaluate the clinical safety and effectiveness of the Envision® surface placed on the TotalCare® frame in pressure ulcer prevention and management, patient comfort, and staff acceptance in the critical care environment

Eligibility criteria: Inclusion Criteria:

* Subject weighs between 70 and 400 pounds Subject to remain on Envision Surface for at least 3 days Subject at risk for pressure ulcers (Braden Score \< 14) or has existing ulcer of any stage Subject is able to provide voluntary consent

Exclusion Criteria:

* Subject requires pulmonary treatment surface Subject declines consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
Study officials:
affiliation: Sinai Hospital of Baltimore / Lifebridge Health
name: Betsy Fisher, RN, CWOCN
role: STUDY_DIRECTOR
References:
Clinical trial NCT05055934: Study of the Effectiveness and Safety of SHR-1314 for Psoriatic Arthritis
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Dose Exploratory Study to Evaluate the Effectiveness and Safety of SHR-1314 Injection in Adult Subjects With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-24
Enrollment: 112
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: This study is a randomized, double-blind, multicenter, placebo-controlled Phase II clinical study, consisting of a 4-week screening period, a 12-week core treatment period, a 12-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 111 adult subjects with psoriatic arthritis.


Eligibility criteria: Inclusion Criteria:

1. The subject voluntarily signs an informed consent form before any procedures related to the research start;
2. Age ≥18 years old and ≤75 years old at the time of signing the informed consent form, regardless of gender;
3. At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR);
4. There is active PsA before randomization;
5. Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis;

Exclusion Criteria:

1. Existence of any of the following medical history or comorbid diseases: drug-induced psoriasis; other active inflammatory diseases or autoimmune diseases; history of organ transplantation; history of lymphocytic proliferation; severe infections, etc.
2. Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past.
3. Those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents.
4. A history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.

Primary outcomes:
measure: Proportion of subjects achieving ACR 20 improvement at week 12
timeFrame: at week 12
Secondary outcomes:
measure: The proportion of subjects who achieved ACR 50 improvement (week 12)
timeFrame: week 12
measure: The proportion of subjects who achieved ACR 70 improvement (week 12)
timeFrame: week 12
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital of the Shanghai FuDan University
state: Shanghai
Study officials:
References:
Clinical trial NCT05257434: Postoperative Outcomes in Patients With Hepato-biliary-pancreatic Cancer According to inBody Test
Official title: Postoperative Outcomes in Patients With Hepato-biliary-pancreatic Cancer According to inBody Test
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: Kochi University
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: surgically treated patients who were suffering from hepato-biliary-pancreatic cancer

Brief summary: postoperative outcomes were evaluated by using inBody test

Detailed description: postoperative outcomes were evaluated by using inBody test

Eligibility criteria: Inclusion Criteria:

* surgically treated patients

Exclusion Criteria:

* a body weight loss of \>10% during the 6 months before surgery; the presence of distant metastases; or seriously impaired function of vital organs because of respiratory, renal, or heart disease

Primary outcomes:
measure: long-term outcomes
timeFrame: 5year
Secondary outcomes:
measure: short-term outcomes
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Kochi
country: Japan
facility: Takehiro Okabayashi
Study officials:
References: