louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04276454: Lymphedema Treatment in Head and Neck Cancer Patients
Official title: Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer
Lymphedema
Treatment
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: Tactile Medical
First posted: 2020-02-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will receive a single intervention.
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to evaluate the result of treatment for neck lymphedema on throat pressure in patients who have received radiation therapy for head and neck cancer.

Detailed description: Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. The lymphedema seen in patients treated for head and neck cancer can be seen externally on the neck and face, as well as internally in the lining of the throat. In this study, the investigators plan to treat the external lymphedema with a device called the Flexitouch Plus, which is already approved by the Food and Drug Administration (FDA) for lymphedema treatment, and to measure the degree of internal lymphedema using a pressure sensor to detect throat muscle pressure before and after the treatment with the Flexitouch Plus device.

Eligibility criteria: Inclusion Criteria:

* Patients with tumors of the nasopharynx, oral cavity, oropharynx, hypopharynx, or larynx who will have radiation therapy as part of their treatment plan
* Both male and females
* 18 to 100 years of age

Exclusion Criteria:

* Significant surgical resection of pharyngeal constrictor muscles
* Patients with persistent or recurrent disease
* Patients who have contraindications to use Flexitouch Plus device

Primary outcomes:
measure: Internal lymphedema measurement
timeFrame: 2 hours
Secondary outcomes:
measure: External lymphedema measurement
timeFrame: 2 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Mihir Bhayani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01216254: Clinical Trial Comparing Outcomes of Breast Conserving Operations With Classic v High-frequency Electrocoagulation
Official title: Prospective, Randomized Clinical Trial Comparing Pain Sensation, Seroma Formation and Quality od Life Following BCT With SLND in Breast Cancer Patients Operated With Classic Versus High-frequency Electrocoagulation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Breast Cancer
Keywords: breast cancer
stage 2
breast conserving therapy
sentinel lymph node dissection
high frequency electrocoagulation
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the outcomes of breast conserving therapy operation depending on the type of surgical tool used: classic electrocoagulation with higher operative temperatures and high frequency electrocoagulation with lower operative temperatures. The investigators would assess the pain levels, length and amount of the lymphatic secretion as well as quality of life following breast conserving surgery.


Eligibility criteria: Inclusion Criteria:

* female
* age 18-100
* breast cancer
* stage IIA and II B (cT1a-3; cN0-1; cM0)
* no previous breast surgery
* no previous cancer
* obtained informed consent

Exclusion Criteria:

* stages I, III, IV
* localised breast infection
* previous breast surgery for any cause
* previous cancer
* no voluntary consent

Primary outcomes:
measure: Pain Control
timeFrame: From the day before surgery up to 12 weeks (+/-2days) after surgery
Secondary outcomes:
measure: Quality of life (QoL)
timeFrame: From the day before surgery up to 12 weeks (+/-2days) after surgery
measure: Length of lymphatic secretion
timeFrame: From the day before surgery up to 12 weeks (+/-2days) after surgery
measure: Amount of lymphatic secretion
timeFrame: From the day before surgery up to 12 weeks (+/-2days) after surgery
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Department of Surgical Oncology
state: Pomorskie
Study officials:
affiliation: Medical University of Gdansk
name: Jacek Zielinski, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Gdansk
name: Janusz Jaskiewicz, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02121054: Research of Resistance to Antiplatelet Agents and Development of Tailored Treatment Model for Patients With Coronary Artery Disease
Official title: Research of Resistance to Antiplatelet Agents and Development of Tailored Treatment Model for Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Coronary Artery Disease
Keywords: Antiplatelet Agents
Drug Resistance
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 1527
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease, Patients with peripheral artery disease

Brief summary: The purpose of this study is to evaluate the prognosis of patients with resistance to antiplatelet agent and develop tailored treatment model for patients with coronary artery disease.


Eligibility criteria: Inclusion Criteria:

* Age \>20
* Patients with coronary artery disease
* Patients with peripheral artery disease

Exclusion Criteria:

* Renal dysfunction
* Hepatic dysfunction
* Major surgery planned within 1 year
* Malignant tumor
* History of gastrointestinal bleeding
* low or high platelet count

Primary outcomes:
measure: Major adverse event
timeFrame: 2 year
Secondary outcomes:
measure: Biomarker
timeFrame: 2 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-Gu
Study officials:
References:
Clinical trial NCT02344654: Fluorescence Cholangiography During Cholecystectomy - a RCT
Official title: Fluorescence Cholangiography Versus X-ray Cholangiography During Laparoscopic Cholecystectomy for Complicated Gallstone Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis
Gallstones
Keywords: Fluorescence
Cholangiography
Indocyanine Green
Cholecystectomy, Laparoscopic
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective is to compare the success rates of intraoperative fluorescent cholangiography using indocyanine green versus conventional X-ray cholangiography for the identification of bile duct anatomy during laparoscopic cholecystectomy for complicated gallstone disease in a randomized design with 120 patients.


Eligibility criteria: Inclusion Criteria:

* Patient scheduled for planned laparoscopic cholecystectomy by one surgeon
* Complicated gallstone disease

Exclusion Criteria:

* Open cholecystectomy
* Allergy towards iodine, urografin or indocyanine green
* Liver or renal insufficiency
* Thyrotoxicosis
* Pregnancy or lactation
* Legally incompetent for any reason
* Withdrawal of inclusion consent at any time

Primary outcomes:
measure: Visualization of the cystic duct - common hepatic duct - common bile duct junction
timeFrame: Intraoperative
Secondary outcomes:
measure: Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography
timeFrame: Intraoperative
measure: Surgeon satisfaction score (Measured on a 5 point VAS scale)
timeFrame: Intraoperative
measure: Per-/postoperative adverse events as a measure of safety and tolerability
timeFrame: Intraoperative
measure: Total cost of operation incl fluorescent/conventional X-ray cholangiography
timeFrame: Admission to discharge from hospital (0-30 days)
Other outcomes:
Locations:
Study officials:
affiliation: Hvidovre University Hospital
name: Lars ML Lehrskov-Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lehrskov LL, Westen M, Larsen SS, Jensen AB, Kristensen BB, Bisgaard T. Fluorescence or X-ray cholangiography in elective laparoscopic cholecystectomy: a randomized clinical trial. Br J Surg. 2020 May;107(6):655-661. doi: 10.1002/bjs.11510. Epub 2020 Feb 14.
citation: Lehrskov LL, Larsen SS, Kristensen BB, Bisgaard T. Fluorescence versus X-ray cholangiography during laparoscopic cholecystectomy: protocol for a randomised trial. Dan Med J. 2016 Aug;63(8):A5261.
Clinical trial NCT02045654: Platelet Response During the Second Cycle of Decitabine Can Predict Response and Survival for Myelodysplastic Syndrome
Official title: Retrospective Study for Predictive Marker for Decitabine Treament in MDS Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myelodysplastic Syndrome
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Histologically confirmed Myelodysplastic syndrome Diagnosed with MDS (de novo or secondary) based on the World Health Organization (WHO) classifications

Brief summary: To assess the efficacy of decitabine and identify predictors for response to decitabine therapy.

Detailed description: * Histologically confirmed Myelodysplastic syndrome Diagnosed with MDS (de novo or secondary) based on the World Health Organization (WHO) classifications
* Survival and response Analysis
* Response rate
* Overall survival
* Leukemia free survival

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed Myelodysplastic syndrome Diagnosed with MDS (de novo or secondary) based on the World Health Organization (WHO) classifications

Primary outcomes:
measure: Response rate
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 1 year
measure: Leukemia free survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Hematology Oncology, Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jun Ho Jang, Pf
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05550454: Cardiac Arrest and Ventilation Method
Official title: Comparison of Manual Ventilation and Automatic Mechanical Ventilation During Cardiopulmonary Resuscitation, Pilot & Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Out-Of-Hospital Cardiac Arrest
Advanced Cardiac Life Support
Ventilation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a study conducted by random assignment to two groups of manual ventilation and automatic mechanical ventilation.
Primary purpose: TREATMENT

Brief summary: Comparison of Manual Ventilation and Automatic Mechanical Ventilation during CPR, Pilot \& Feasibility Study (CAVE-I trial)

Detailed description: This is a preliminary randomized clinical trials comparing the effectiveness of the automatic mechanical ventilation method compared to manual ventilation methods commonly performed during advanced cardiac life support (ACLS) in emergency room for out-of-hospital cardiac arrest.

Eligibility criteria: Inclusion Criteria:

* Out-of-hospital cardiac arrest (OHCA)
* Transferred by only EMS without prehospital return of spontaneous circulation (ROSC)
* ACLS for at least 20 minutes in the emergency room
* Arterial blood gas analysis at least once during ACLS

Exclusion Criteria:

* In-hospital cardiac arrest (IHCA)
* Not transferred by Emergency Medical Service
* ROSC gained before arriving at the ER
* OHCA caused by trauma
* ACLS is not performed for more than 20 minutes because the death is obvious
* Not able to intubate the trachea

Primary outcomes:
measure: ROSC: return of spontaneous circulation
timeFrame: Within 20 minutes of ACLS
Secondary outcomes:
measure: Arterial blood gas analysis (ABGA) parameters
timeFrame: The first test was conducted within 5 minutes of ACLS, and the second test 10 minutes after the first test.
measure: Ventilation parameters
timeFrame: During the entire ACLS time after randomization and endotracheal intubation
Other outcomes:
measure: Peak pressure (only in automatic mechanical ventilation group)
timeFrame: Randomized by automatic mechanical ventilation and during the entire ACLS time after endotracheal intubation
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Goverment-Seoul National University Boramae Medical Center
state: Korea (the Republic Of)
Study officials:
References:
Clinical trial NCT02193854: Teledermatology Solution Through Mobile Phone in Rural Mongolia
Official title: Teledermatology Solution Through Mobile Phone in Rural Mongolia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Distance
Keywords: Telemedicine
Mobile phone
Rural physicians
Mongolia
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Health Science University of Mongolia
First posted: 2014-07-18
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objective This study is aimed to estimate the distance, time and the cost of travel saved by patients who are seeking tele-dermatology (TD) service though smart mobile phones in the resource poor settings at the rural clinics of Mongolia.

Methods A cluster-randomised trial was conducted for six months at the 20 rural health clinics selected from three districts in Mongolia. With a computer-generated sequence, health clinics were randomly allocated either to the intervention group, in which all general practitioners (GPs) received TD consultation through Sana system, or the control group, in which GPs referred patients to the dermatologist at district hospital whenever needed. The primary outcome was to estimate the distance traveled, times spend and the cost of travel required in receiving dermal care for patients in rural Mongolia. Analysis was done to estimate the difference between the aforementioned parameters among intervention and control groups.

Detailed description: The investigators used Sana system, that is a mobile phone-based, open source software platform for telemedicine services. The Android-based system supports multimedia, location-based data, and text. In the village health clinic, a healthcare worker will interact with a patient and collects data through a step-by-step clinical questionnaire on a smart mobile phone. As patients' data is uploaded to an open source electronic medical record system (OpenMRS) with a diagnosis-specific information and images. The consultant can access the clinical information about the patient and make appropriate diagnoses and treatment recommendations from the secondary hospital.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-98 years visiting with dermal problem.

Exclusion Criteria:

* Patients who do not need dermal care.
* Patients who are already under treatment for dermal problem.

Primary outcomes:
measure: Comparison between the number of referrals in the control and intervention groups
timeFrame: up to 5 months
Secondary outcomes:
measure: Satisfaction by physicians and patients by questionnaire
timeFrame: up to 5 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shabbir Syed Abdul
Study officials:
affiliation: Taipei Medical University
name: Yu-Chuan Li, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00531154: Evaluation of the Dental Health Condition in Obesity Patients Before and After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Periodontitis
Caries
Periapical Lesion
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-09-18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The aim of this study is to investigate whether there was an association between obesity and periodontitis, tendency to caries and periapical lesions.

People who have a higher body mass index produce cytokines (hormone-like proteins), that lead to systemic/chronic inflammation (like periodontitis and periapical lesions), and obesity related dietary habits could result in an increment of dental caries because both the amount and the frequency of sucrose ingestion are important factors associated with the aetiology of the oral disease.


Eligibility criteria: Inclusion Criteria:

* Obese pateints who intended to go bariatric surgery.

Exclusion Criteria:

* Coronary heart disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
name: Ilana Heling, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pischon N, Heng N, Bernimoulin JP, Kleber BM, Willich SN, Pischon T. Obesity, inflammation, and periodontal disease. J Dent Res. 2007 May;86(5):400-9. doi: 10.1177/154405910708600503.
citation: Linden G, Patterson C, Evans A, Kee F. Obesity and periodontitis in 60-70-year-old men. J Clin Periodontol. 2007 Jun;34(6):461-6. doi: 10.1111/j.1600-051X.2007.01075.x. Epub 2007 Apr 2.
citation: Karjalainen S. Eating patterns, diet and dental caries. Dent Update. 2007 Jun;34(5):295-8, 300. doi: 10.12968/denu.2007.34.5.295.
citation: Heling I, Sgan-Cohen HD, Itzhaki M, Beglaibter N, Avrutis O, Gimmon Z. Dental complications following gastric restrictive bariatric surgery. Obes Surg. 2006 Sep;16(9):1131-4. doi: 10.1381/096089206778392211.
Clinical trial NCT03515954: AS-OCT Guided Treatment of Diffuse CSCC
Official title: Anterior Segment Optical Coherence Tomography (AS-OCT) Guided Treatment of Diffuse Conjunctival Squamous Cell Carcinoma (CSCC) With Excision, Amniotic Membrane Graft Using Fibrin Glue and Topical Mitomycin C (MMC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conjunctival Neoplasms
Keywords: conjunctiva
squamous neoplasia
amniotic
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study included 8 eyes of 8 patients. The mean age of all patients was 51.9 ± 9.9 years. There were 7 males (87.5%) and 1 female (12.5%).

Brief summary: A prospective study was performed on 8 eyes of 8 patients who underwent amniotic membrane graft after diffuse conjunctival squamous cell neoplasia excision followed by topical mitomycin C 0.04% eye drop between March 2014 and January 2018.

Detailed description: Surgical excision of the conjunctival tumour . A superficial corneal scraping was performed for corneal lesion then double freeze-thaw cryotherapy was applied to limbal edge and conjunctival margins.The amniotic membrane graft was secure and attached to the sclera and conjunctiva using ﬁbrin glue.Topical mitomycin C 0.04%eye drop was prescribed 4 times daily per treatment cycle (1 cycle=1 week on 1 week off).

Eligibility criteria: Inclusion Criteria:

* diffuse Ocular Surface Squamous Neoplasia

Exclusion Criteria:

* localized OSSN (less than ﬁve clock hours in limbal extent)

Primary outcomes:
measure: The recurrence rate of lesion
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04149054: Mobile Health App to Reduce Diabetes in Latina Women
Official title: Mobile Health App to Reduce Diabetes in Latina Women With Prior Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gestational Diabetes
Lead sponsor: Environment and Health Group, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-04
Enrollment: 18
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The proposed project sought to develop a culturally- and individually-tailored, plain-language Spanish/English mobile phone intervention for Latinas with prior gestational diabetes (GDM). The intervention is based on earlier in-person to online modification of the CDC-funded Diabetes Prevention Program (DPP), for women with prior GDM led by co-investigator Dr. Ellen Seely of Brigham and Women's Hospital.

Detailed description: The specific aims of the study were as follows:

Primary Aim 1: Develop a culturally-tailored mobile phone intervention for Latinas with prior GDM based on Brigham \& Women's Hospital online DPP.

Primary Aim 2: Conduct a pilot trial of the intervention.

Primary Aim 3:Evaluate implementation feasibility.

Eligibility criteria: Inclusion Criteria:

* Latina women
* ages 19-45
* with prior gestational diabetes by Carpenter and Coustan criteria
* within the past 5 year validated by medical record review
* own an Android or iOS smartphone.

Exclusion Criteria:

* Diagnosis of pre-pregnancy diabetes(type 1,2, or secondary diabetes)
* underlying disease that might interfere with participation in study (e.g.,significant gastrointestinal conditions)
* taking certain medications (e.g., glucocorticoids)
* pregnancy/undergoing infertility treatment.

Primary outcomes:
measure: Sallis Self Efficacy for Healthy Eating Scale
timeFrame: eight weeks
measure: Sallis Self Efficacy for Physical Activity Scale
timeFrame: eight weeks
Secondary outcomes:
measure: Body weight
timeFrame: eight weeks
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Environment and Health Group
state: Massachusetts
Study officials:
References:
citation: Seely EW, Weitzman PF, Cortes D, Romero Vicente S, Levkoff SE. Development and Feasibility of an App to Decrease Risk Factors for Type 2 Diabetes in Hispanic Women With Recent Gestational Diabetes (Hola Bebe, Adios Diabetes): Pilot Pre-Post Study. JMIR Form Res. 2020 Dec 31;4(12):e19677. doi: 10.2196/19677.