louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01466777: Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy
Official title: Robotic-assisted vs. Traditional Laparoscopic Surgery in Treatment of Endometrial Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometrium Cancer
Keywords: Endometrium cancer
Robotic-assisted laparoscopy
Traditional laparoscopy
Laparoscopic surgery
Treatment
Operation time
Bleeding
Complications
Conversions
Pelvic lymph node
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 85
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 compare the robotic-assisted laparoscopic surgery to the traditional laparoscopic surgery in endometrial cancer patients.

The study is prospective and the patients are randomised into two groups of 50 patients each. Randomisation is done with Minim-programme and patients age and Body mass index are taken into account.

The primary endpoint is the operation time. The number of patients in this study is based on the non-inferiority design. Presumption is that the operation time in robotic-assisted laparoscopy will be 25% longer.

Secondary endpoints include:

1. bleeding
2. complications
3. conversions
4. number of pelvic lymph nodes


Eligibility criteria: Inclusion Criteria:

* Endometrial cancer operations, which means hysterectomy, bilateral salphingo-oophorectomy and pelvic lymphadenectomy
* Gr 1 and 2 differentiation type

Exclusion Criteria:

* The operation cannot be made with an laparoscopy operation
* Age more than 85 years or young under 30 years patient

Primary outcomes:
measure: the operation time
timeFrame: From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours
Secondary outcomes:
measure: bleeding
timeFrame: Duration of hospital stay, an expected average of 5 weeks
measure: Number of participants with adverse events
timeFrame: Duration of hospital stay, an expected average of 5 weeks
measure: Pain
timeFrame: Duration of hospital stay, an expected average of 5 weeks
measure: pelvic lymph node volumes
timeFrame: Duration of hospital stay, an expected average of 5 weeks
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
state: P.O.Box 2000
Study officials:
References:
citation: Vuorinen RK, Maenpaa MM, Nieminen K, Tomas EI, Luukkaala TH, Auvinen A, Maenpaa JU. Costs of Robotic-Assisted Versus Traditional Laparoscopy in Endometrial Cancer. Int J Gynecol Cancer. 2017 Oct;27(8):1788-1793. doi: 10.1097/IGC.0000000000001073.
Clinical trial NCT02110277: Photoacoustic Imaging of the Ovary
Official title: Photoacoustic Imaging of the Ovary
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Epithelial ovarian cancer
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-04-10
Enrollment: 2
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to develop technology to image the ovaries in order to better evaluate ovarian disease and to study how these experimental imaging techniques might work together or separately to improve our ability to detect ovarian cancer.

Detailed description: Epithelial ovarian cancer causes the highest mortality of any of the gynecologic cancers although it is the second most common gynecologic malignancy. Ovarian cancer is not usually detected earlier than Stage III or IV because it is usually asymptomatic; yet survival is high with early stage disease. In addition, women with a pelvic mass noted on ultrasound that undergo oophorectomy have only a 1-3% risk of malignancy and thus 97-99% will be overtreated because of our inability to reliably differentiate benign from malignant masses with ultrasound. BRCA1 testing and family history will identify certain high-risk individuals who have a higher risk of malignancy and need a modality that will be more reliable in detecting early cancers to provide more accurate surveillance.We are developing a new transvaginal imaging device optimized for ovarian cancer detection, diagnosis and validated from ex vivo and in vivo clinical studies. This automated system may provide an early diagnostic tool for ovarian cancer in the future.

Eligibility criteria: Inclusion Criteria:

* All patients, twenty one years or older, referred to the University of Connecticut for conditions necessitating oophorectomy.
* Patients cannot be pregnant or wish to become pregnant.
* Willingness to participate in the study.

Exclusion Criteria:

* All Subjects who fail to meet the inclusion criteria are ineligible for the study.

Primary outcomes:
measure: To Measure Photoacoustic Imaging (PAI)/Ultrasound Signature From Ovaries Prior to Surgery Using the Ratio of Deoxy/Oxy Hb
timeFrame: 5 years
Secondary outcomes:
measure: Pathologic Diagnosis and in Vivo Imaging
timeFrame: 5 years
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
Study officials:
affiliation: UConn Health
name: Molly Brewer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05500677: Lidocaine Spray for Pain Control in Rib Fractures
Official title: Comparison of the Analgesic Efficacy of Lidocaine Spray Versus Tramadol and Fentanyl for Pain Control in Rib Fractures: A Prospective, Randomized, Controlled and Open-label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rib Fractures
Analgesia
Keywords: Analgesia
Fentanyl
Lidocaine spray
Rib fracture
Tramadol
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Pain control in rib fracture
Primary purpose: TREATMENT

Brief summary: In this study, we aimed to compare the analgesic efficacy of lidocaine spray with tramadol hydrochloride and fentanyl citrate in rib fractures.

Detailed description: Patients over the age of 18 who came to our emergency department with blunt chest trauma were divided into three groups. Groups was created from patients who were given lidocaine 10% spray (local), i.v. 100 mg of tramadol and i.v. fentanyl 50 mcg. A total of 48 patients, each of whom were 16, were included in the study. Numerical rating scale (NRS) pain scores of the patients at baseline, 15th, 30th and 60th minutes were compared. These scores and the amount of falls at follow-up were analyzed comparatively between the 3 groups.

Eligibility criteria: Inclusion Criteria:

* Open conscious
* Oriented and cooperative
* Blunt thoracic trauma and rib fracture
* Numerical rating scale (NRS) was 5 or higher

Exclusion Criteria:

* Patients who refused to participate in the study
* Detected or suspected pregnancy
* Known history of allergy or other adverse reaction to the drugs used in the study
* History of sedative drug use or drug addiction
* Analgesic use within 6 hours of admission to the emergency department
* Needed emergency tube thoracostomy or surgical intervention
* Hemodynamically unstable
* Open and/or infected wounds in the fracture area

Primary outcomes:
measure: Pain control
timeFrame: 60th minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Ahmet Burak Erdem, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05937477: Developing Artificial Intelligence-based Algorism to Predict Side Effects and Symptoms From Chemotherapy
Official title: Developing Artificial Intelligence-based Algorism Based on Life-log Data Acquired From Wearable Device for the Prediction of Chemotherapy-induced Side Effects and Symptom
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Head and Neck Cancer
Esophageal Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing chemotherapy after being diagnosed with lung, head and neck, or esophageal cancer.

Brief summary: In this study, the investigators obtain wearable disease based biomarkers from patients diagnosed with cancer and undergoing chemotherapy, and simultaneously measure patient self-reported adverse events through an app to evaluate chemotherapy completion rates, emergency room visits, and frequency of CTCAE adverse events.

The investigators will develop an artificial intelligence-based algorism that can predict patients' side effects based on biomarkers alone.

Detailed description: In this study, patients diagnosed with lung, head and neck, and esophageal cancers and undergoing chemotherapy will be measured for self-reported side effects using a wearable device to collect biomarkers through an app, and the association between patient quality of life and side effects and biomarkers obtained from the wearable device will be analyzed. On the other hand, blood (EDTA 3cc) for pharmacogenomics testing will be tested once at any point during the study period as an indicator associated with side effects after chemotherapy.

Eligibility criteria: Inclusion Criteria:

* 20 years of age or older
* Must have diagnosed with lung, head and neck, or esophageal cancer,

  1. scheduled to receive their first treatment in preoperative or postoperative chemotherapy.
  2. scheduled for systemic chemotherapy due to recurrence or metastasis.
* Eastern Cooperative Oncology (ECOG) performance status of 0 to 2.
* Patients who have access to a smartphone and can use the mobile app on their own.
* Understand the purpose of the study and agree to participate in the study.

Exclusion Criteria:

* Patients who, in the judgment of the researcher, have difficulty using the application.
* Patients who are judged by the medical staff to be unable to participate in the study.

Primary outcomes:
measure: Developing artificial intelligence prediction algorism
timeFrame: Through study completion, an average of 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnamgu
Study officials:
References:
Clinical trial NCT00500877: Mood Management Phone Counseling in Smoking Cessation
Official title: Mood Management Phone Counseling in Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cigarette Smoking
Keywords: Smoking cessation
Phone Counseling
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-07-13
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Information obtained from this study will help us to have a better idea of how phone counseling may facilitate the process of quitting smoking for individuals with a history of recurrent depression.

Detailed description: Adult smokers with a history of recurrent major depression (MDD) report higher levels of depressive symptoms when presenting for smoking cessation treatment and have poor smoking outcomes relative to other smokers. Carefully conducted clinical trials have supported the efficacy of cognitive-behavioral mood management treatment for depression in improving smoking cessation outcomes in this high-risk group. Although efficacious, these intensive group treatments require significant resources and thus may have limited impact outside of specialized smoking cessation programs. In the present study we will develop and obtain preliminary data on the efficacy of proactive telephone counseling for smoking cessation that integrates cognitive-behavioral mood management skills training for depression (MM). Smokers with a history of recurrent MDD will be randomly assigned to the proactive telephone counseling for smoking cessation with mood management (MM) or a standard proactive telephone counseling (ST) comparison condition. We expect that this program of research will result in the development of a specialized, efficacious treatment with broad reach into a significant subpopulation of smokers at greatest risk for difficulties quitting, and will therefore have important clinical and public health significance in decreasing the overall prevalence of cigarette smoking.

Eligibility criteria: Inclusion Criteria:

* history of two or more past episodes of depression
* regular cigarette smoker for at least one year
* currently smoking 10 or more cigarettes each day
* want to quit smoking

Exclusion Criteria:

* Current Depressive Episode
* Current Alcohol of Substance abuse
* Pregnant, planning to become pregnant

Primary outcomes:
measure: Smoking Abstinence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: David Strong, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03823677: Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia
Official title: Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia, Altitude
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 15 different Groups are analysed: control Group, 5000ft Group, 8000 ft Group, 10000ft Group and 15000ft Group - all for 15, 30, and 60 minutes.
Primary purpose: DIAGNOSTIC

Brief summary: This study analyses both Protein Expression and emotional alterations during hypobaric hypoxia in volunteers of different groups.

Detailed description: This study analyses both Protein Expression and emotional alterations during hypobaric hypoxia in volunteers of different groups.

15 different Groups are analysed: control Group, 5000ft Group, 8000 ft Group, 10000ft Group and 15000ft Group - all for 15, 30, and 60 minutes.

Eligibility criteria: Inclusion Criteria:

* Helathy

Exclusion Criteria:

* Ear problems

Primary outcomes:
measure: Protein Expression before hypoxia
timeFrame: Measurement immediately 1 minute before of hypoxia/experiment
measure: Protein Expression after hypoxia
timeFrame: Measurement immediately and at termination (i.e., 1 minute after) of hypoxia/experiment
measure: Emotional assessment tears
timeFrame: Measurement starts immediately with hypoxia in the pressure chamber. duration 10 minutes
measure: Emotional assessment
timeFrame: Measurement in the pressure chamber after tears test (i.e. 10 minutes after start). duration 10 minutes
measure: Emotional assessment mood
timeFrame: Measurement in the pressure chamber after stroop test (i.e. 20 minutes after start). duration 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
state: NRW
Study officials:
affiliation: University Hospital of Cologne
name: Jochen Hinkelbein
role: STUDY_CHAIR
References:
Clinical trial NCT00240877: Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the safety of a vaccine in healthy adults prior to the release of the trivalent vaccine (FluMist).

Detailed description: The primary study objective is to assess the safety of a monovalent vaccine of a new 6:2 reassortant in healthy adults prior to the release of the trivalent vaccine (FluMist). Safety will be demonstrated by similar fever rates (oral temperature ≥101°F) in vaccine and placebo recipients.

Eligibility criteria: Inclusion Criteria:

* 18-64 years of age (not yet reached their 65th birthday);
* In good health;
* Available by telephone;
* Ability to understand and comply with the requirements of the protocol; and
* Signed informed consent.

Exclusion Criteria:

* Any condition, other than age, for which the inactivated influenza vaccine is indicated, including: chronic disorders of the pulmonary or cardiovascular systems, including asthma; chronic metabolic diseases (including diabetes mellitus) renal dysfunction, or hemoglobinopathies which required regular medical follow-up or hospitalization during the proceeding year;
* Acute febrile (\>100.0°F oral) illness or clinically significant respiratory illness within the 14 days prior to enrollment;
* Hypersensitivity to egg or egg protein;
* Signs or symptoms of any immunosuppressive or immune deficiency disease, including HIV infection, or ongoing immunosuppressive therapy; or an immunosuppressed individual living in the same household;
* Participation in another investigational trial within one month prior to enrollment or expected enrollment in another investigational trial during this study; and
* Any condition that in the opinion of the investigator, might interfere with the vaccine evaluation.

Primary outcomes:
measure: - The primary endpoint of this study is fever defined as oral temperature ≥101°F
timeFrame: Days 0-7
Secondary outcomes:
measure: All other reported reactogenicity events and other adverse events.
timeFrame: After 7 days after vaccination
Other outcomes:
Locations:
city: Miami
country: United States
facility: SFBC International Inc
state: Florida
Study officials:
affiliation: MedImmune LLC
name: Robert Walker, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05271877: Evaluation of Surgical and Obstetric Outcomes in Pregnant Women Undergoing Operative Laparoscopy
Official title: Evaluation of Surgical and Obstetric Outcomes in Pregnant Women Undergoing Operative Laparoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Related
Laparoscopy
Keywords: Pregnancy
Laparoscopy
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women undergoing laparoscopy

Brief summary: Laparoscopy, when applicable, is the current gold standard management for abdominal and pelvic surgery. Although accumulating evidence suggests that laparoscopy is associated with reduced intraoperative and postoperative morbidity, reduced hospital stay, better recovery and cosmesis compared with open surgery (laparotomy), the use of this technique in pregnant women is still debated. Considering this point, we aimed to collect retrospectively cases of laparoscopic surgery during pregnancy, regardless of the indication and gestational age, in order to analyze both surgical and obstetric outcomes during and after the procedure.


Eligibility criteria: Inclusion Criteria:

* Pregnant women (regardless of gestational age)
* At least one indication for laparoscopic surgery

Exclusion Criteria:

* None

Primary outcomes:
measure: Intraoperative complication
timeFrame: From the beginning to the end of laparoscopy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Antonio Simone Laganà, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02448277: Comparison of Different Tools Inserted Nasal Endotracheal Tube
Official title: A Comparson Among the Use of Direct Laryngoscope.AirwayScope and GlideScope in General Anesthetized Patients Who Require Nasal Endotracheal Tube Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation, Nasotracheal Intubation
Keywords: Macintosh laryngoscope, Pentax, Glidescope
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2015-05-19
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nasotracheal intubation (NTI) is usually required in patients undergoing maxillofacial surgery. Though video-scopes have been demonstrated to well perform in oral endotracheal intubation, limited information presents in NTI. The aim of the study is to compare the efficacy of video-scopes in NTI and compared with the traditional direct laryngoscope.


Eligibility criteria: Inclusion Criteria:

* patients with American Society of Anesthesiologists physical status I-III
* aged 20-65 years
* Requiring Nasotracheal Intubation under general anesthesia

Exclusion Criteria:

* mouth open \< 3 cm
* limited neck extension \< 25 degree
* Ankylosing arthritis patients.
* BMI≧35 kg/m2

Primary outcomes:
measure: number of the patients with successful nasotracheal intubation and scoring difficult intubation scale
timeFrame: half an hour
Secondary outcomes:
measure: time to intubate
timeFrame: 10 minutes
Other outcomes:
measure: postoperative nasal bleeding, sore throat and hoarseness
timeFrame: 2 days
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Department of anesthesiology, Kaohsiung Medical University, Taiwan
name: Kuang Yi Tseng, M.D.
role: STUDY_DIRECTOR
References: