louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01679522: Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer
Official title: Prospective Randomized Comparison of Single-port and Four-port Laparoscopic Staging Operation for Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Keywords: endometrial cancer
laparoscopic surgical staging
single-port
four-port
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 107
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the feasibility, safety, and efficacy between single-port and four-port laparoscopic surgical staging in patients with early stage endometrial cancer.


Eligibility criteria: Inclusion Criteria:

* Previously untreated, histologically confirmed endometrial cancer
* Presumed FIGO stage 1
* Endometrioid adenocarcinoma
* patient who is planned to undergo surgical staging
* adequate oran function

  1. WBC \> 3000 cells/mcl
  2. Platelets \> 100000/mcl
  3. Creatinine \< 2.0 mg/dL
  4. Bilirubin \< 1.5 \* normal and SGOT or SGPT \< 3 \* normal
* American Society of Anesthesiologists Physical Status I-II
* Eastern Cooperative Oncology Group performance status 0-2
* Patients who have signed an approved Informed Consent

Exclusion Criteria:

* Uncontrolled medical disease
* Active infectious disease requiring antibiotics
* Previous pelvic radiation therapy
* Pregnant and lactating woman
* Patient who requires additional surgical procedures which are not necessary for surgical staging of endometrial cancer

Primary outcomes:
measure: operating time
timeFrame: 1 day (Immediately after operation)
measure: Number of lymph nodes retrieved
timeFrame: 1 week after surgery
Secondary outcomes:
measure: Postoperative pain
timeFrame: within 1 week after surgery
measure: Postoperative analgesics requirement
timeFrame: within 1 week after surgery
measure: transfusion requirement and amount
timeFrame: within 1 week after surgery
measure: postoperative complications
timeFrame: within 1 month after surgery
measure: recurrence free survival
timeFrame: 34 months after surgery
measure: overall survival
timeFrame: 34 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Joo-Hyun Nam, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05157022: Comparative Effects of Radial and Focused Extracorporeal Shock-wave Therapies in Coccydynia
Official title: Comparative Effects of Radial and Focused Extracorporeal Shock-wave Therapies in Coccydynia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coccyx Injury
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 69
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: Comparison of the efficacy of coccydynia treatment with two different probes of the ESWT device


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of coccydynia by clinical examination and X-ray imaging.
* be aged ≥18 at the time of diagnosis
* be give informed consent

Exclusion Criteria:

* Malignancy
* Those who have received ESWT treatment before
* Pediatric patients
* Patients with infection.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 1 minute
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yüzüncü Yıl Üniversitesi Tıp Fakültesi
Study officials:
affiliation: Yüzüncü Yıl Üniversitesi Tıp Fakültesi
name: Volkan Şah
role: STUDY_DIRECTOR
References:
Clinical trial NCT05341622: Mailed FIT Outreach 2022
Official title: Pragmatic Trial of Behavioral Interventions to Increase Response to Mailed FIT Outreach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Colon Cancer
Keywords: prevention
cancer screening
mailed FIT
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 5460
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This project aims to evaluate different approaches to increase colorectal cancer screening among primary care patients at Penn Medicine through a centralized screening outreach program. In a pragmatic trial, we will evaluate different approaches to increase response rate to mailed fecal immunochemical test (FIT) kits among eligible patients, including differentiated packaging, sending text reminders, and personalized reminders.

Detailed description: While colonoscopy procedures are recommended by guidelines for early detection of colorectal cancer, colonoscopy access remains limited due to delays in screening due to the pandemic and capacity issues. In this project, we will evaluate different ways of reaching out to eligible patients to encourage them to participate in colorectal cancer screening using fecal immunochemical testing (FIT). In a mailed FIT outreach campaign, we will compare user friendly packaging, text messaging, and personalized reminders to standard outreach with the goal of increasing colorectal cancer screening uptake.

Eligibility criteria: Inclusion Criteria:

1. Patients ages 50-74 with Penn as preferred lab
2. Followed by Primary Care with a participating Penn Medicine PCP listed and at least one visit in the last 2 years
3. Not up to date on colorectal cancer screening per Health Maintenance (no colonoscopy in the last 10 years, stool testing in the last year, flexible sigmoidoscopy in the last 5 years, FIT-DNA in the last 3 years).

Exclusion Criteria:

1. Personal or significant family history of CRC, colonic polyps, hereditary nonpolyposis colorectal cancer syndrome, familial adenomatous polyposis syndrome, other gastrointestinal cancer, gastrointestinal bleeding, iron-deficiency anemia, or inflammatory bowel disease
2. History of total colectomy, dementia or metastatic cancer
3. Currently on hospice or receiving palliative care
4. Uninsured or self-pay patients
5. Currently scheduled for a colonoscopy or sigmoidoscopy

Primary outcomes:
measure: FIT Completion
timeFrame: 4 months
Secondary outcomes:
measure: FIT Completion
timeFrame: 6 months
measure: Colorectal Cancer (CRC) Screening Completion (Any)
timeFrame: 6 months
measure: FIT Positive Follow-up Scheduling
timeFrame: 6 months
measure: FIT Positive Follow-up Completion
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Shivan Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03039322: Golgi Protein for HCC Diagnosis
Official title: Golgi Protein 73 for Diagnosis of HCC in Egyptian Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Screening for Hepatocellular Carcinoma
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group I: Included 45 patients with liver cirrhosis due to HCV infection. Liver cirrhosis was diagnosed clinically, laboratory, and radiologically. Chronic HCV infection was diagnosed by positive HCV antibody and positive quantitative HCV PCR.

Group II: Included 45 patients with Hepatocellular carcinoma (HCC) on top of HCV cirrhosis diagnosed by two imaging modalities, abdominal ultrasound and the characteristic arterial enhancement and venous washout in Tri-phasic CT abdomen.

Brief summary: This case-control study was conducted on 90 patients who were equally divided into two groups. Group 1 included 45 patients with HCV-related chronic liver disease without clinical or radiological evidence of HCC (control group), and Group 2 included 45 patients diagnosed to have HCC by Triphasic abdominal CT (patient group). Serum AFP and GP73 were measured using ELISA technique


Eligibility criteria: Inclusion Criteria:

* patients were older than 18 years.

Exclusion Criteria:

* patients with hepatic focal lesions not due to HCC such as Hemangioma, Hepatic cyst, and liver metastases; patients infected with HIV; patients with any autoimmune disease; or patients with metastatic disease.

Primary outcomes:
measure: Golgi protein correlated with presence of HCC
timeFrame: within one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01706822: Radial Reload Laparoscopic LAR Case Series
Official title: Evaluating the Radial Reload Stapler With Tri-Staple TM Technology During Laparoscopic Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Colorectal Cancer
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
Collaborators: name: University Hospitals Cleveland Medical Center
name: Duke University
First posted: 2012-10-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Radial Reload Stapler during laparoscopic low anterior resection (LAR) or anterior proctosigmoidectomy for rectal cancer by assessing the primary and secondary endpoints.


Eligibility criteria: Inclusion Criteria:

1. The subject is able to understand and sign Informed Consent Form.
2. The subject is between 18-85 years of age.
3. The subject is anticipated to undergo a resection of the rectum with anastomosis below the peritoneal reflection.
4. The subject is anticipated to undergo mobilization and stapling of the rectum laparoscopically.

Exclusion Criteria:

1. Any female patient, who is pregnant, suspected pregnant, or nursing.
2. The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
3. The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.

Primary outcomes:
measure: The Surgeon's Ability to Achieve a Staple Line at the Desired Level of the Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met
timeFrame: Operative
measure: The Ability to Achieve Adequate Distal Margins (Defined as >2cm [or >1cm With Clear Histologic Evaluation]) in the Low Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met
timeFrame: Operative
Secondary outcomes:
measure: Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree
timeFrame: Operatively
measure: Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree
timeFrame: Operatively
measure: Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree
timeFrame: Operatively
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Conor Delaney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06749522: Radiological Spectrum Of Fatty Liver Correlate With High Resolution Ultrasonography Of Fibrosis And Cirrhosis
Official title: Radiological Spectrum Of Fatty Liver Correlate With High Resolution Ultrasonography Of Fibrosis And Cirrhosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fibrosis
Cirrhosis
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: to compare the Radiological Spectrum Of Fatty Liver Correlate With High Resolution Ultrasonography (CT, MRI) Of Fibrosis And Cirrhosis

Brief summary: Fatty liver is a condition in which fat builds up in liver. it is very common health issue.it is major public health problems in the world. there is particular concern because fatty liver causes mortality among patients. The incidence and prevalence of disease vary with time. Fibrosis is thickening of connective tissues which is usually as a result of injury and long term inflammation. Cirrhosis is severe scarring of liver which is caused by long term liver damage. The scar tissue replaces healthy tissues which leads to loss of liver function. The Objective of study is to look into radiographic features of fatty liver disease. The high resolution ultrasonography will give more detailed view of disease. The study inclued 150 participants.

Detailed description: The other liver conditions like fibrosis and cirrhosis are also examined and correlated with fatty liver disease. The CT and MRI are used to compare with HR ultrasonographic findings. Descriptive statistics and comparative statistics are used to interpret data.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of fatty liver (steatosis), fibrosis, or cirrhosis.
* Patient consent to undergo imaging and participate in the study.

Exclusion Criteria:

* Other Liver Diseases: Exclusion of patients with other significant liver conditions (e.g., viral hepatitis, autoimmune liver diseases) unless specified.
* Pregnant women may be excluded due to imaging concerns.
* Poor quality or incomplete imaging studies.
* Presence of other severe systemic illnesses that could affect liver function or imaging.
* Recent liver surgeries or invasive procedures that might affect imaging results

Primary outcomes:
measure: CT
timeFrame: 12 Months
measure: MRI
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Sādiqābād
country: Pakistan
facility: AL-NAWAZ HOSPITAL,Tillu Road
state: Punjab
Study officials:
References:
Clinical trial NCT04715022: Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
Official title: Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Hypertension
Cardiovascular Diseases
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 23
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main purpose of research is to examine and understanding the development of hypertension in obese adults with insulin resistance. Findings from our studies will identify unique mechanisms that can be targeted to limit increases in vascular dysfunction and reduce the excessively high prevalence of hypertension and risk for cardiovascular disease (CVD).

This study is testing the health of the blood vessels and the activity of the nerves that control the blood vessels in adults with insulin resistance. The extent to which ascorbic acid (Vitamin C) improves the function of the blood vessels will be determined. The primary outcome is blood pressure, which is the result of blood vessel health and activity of the nerves, and the reduction in blood pressure that is observed with ascorbic acid.


Eligibility criteria: Inclusion Criteria:

1. Obese: BMI \>30 m/kg2
2. Middle-aged: 35-65 years
3. Participants must be willing and able to discontinue taking any vitamin C or E supplements or omega-3 fatty acids beginning 2 weeks prior.
4. Able and willing to provide written informed consent

Exclusion Criteria:

1. Diabetes mellitus: fasting glucose \< 1267 mg/dL and/or HbA1c \< 6.5%
2. Currently taking a statin or antihypertension medication
3. Hyperlipidemia: Fasting triglycerides \< 250 mg/dL
4. Hypertension: \<130/80 mmHg
5. History of heart disease (e.g., myocardial infarction, stent)
6. History of vascular disease (e.g., bypass, stroke)

Primary outcomes:
measure: Efficacy of infusion of ascorbic acid
timeFrame: 30 minutes
measure: Efficacy of infusion of ascorbic acid
timeFrame: 60 minutes
measure: Efficacy of infusion of ascorbic acid
timeFrame: 90 minutes
measure: Efficacy of infusion of ascorbic acid
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Seth Holwerda, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03792022: Timeliness and Completeness of Routine Childhood Vaccinations by 2 Years of Age in Nigeria.
Official title: Fully Vaccinated Yet Under-vaccinated: Timeliness and Completeness of Routine Childhood Vaccinations by 2 Years of Age in Nigeria
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaccination Failure
Lead sponsor: Lifespan Healthcare Resource Limited
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2019-01-03
Enrollment: 1800
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Vaccination records of children who have attended immunization clinics for the last 24 months.

Brief summary: The timeliness of routine childhood immunization should be an important component in measuring vaccination coverage rates especially in LMIC countries like Nigeria, yet this is overlooked. This study will determine the age- specific immunization timely uptake rates for the various vaccines covered in the routine childhood immunization and seek out factors that affect timely vaccine uptake among Nigerian children.

Detailed description: This study will determine the extent of timely and complete routine childhood vaccination uptake in Nigeria. The investigators will also seek to understand the factors that influence timely/complete uptake and make recommendations. this study will also determine if the present immunization records system in Nigeria is capable of measuring timely immunization uptake.

Eligibility criteria: Inclusion Criteria:

* Received all vaccines Available immunization records

Exclusion Criteria:

* Did not receive all vaccines Non- available immunization records

Primary outcomes:
measure: Age specific timely vaccination rate for all vaccines in routine vaccination schedule
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03573622: A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions
Official title: A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2018-06-29
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study
Primary purpose: TREATMENT

Brief summary: A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions

Detailed description: To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg, Anpl-one SR Tab. 300mg (Reference) and generic Sarpogrelate HCl 300mg (Test), after a single oral dose administration in healthy volunteers under fasting condition: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking, male and female subjects, 19 years of age or older
* BMI ≥ 18.0 and ≤ 30.0 kg/m2.
* Females who participate in this study will be of childbearing or non-childbearing potential

Exclusion Criteria:

* Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results

Primary outcomes:
measure: Maximum Plasma Concentration
timeFrame: 0-24hr
measure: Area under the plasma concentration versus time curve
timeFrame: 0-24hr
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Daewoong pharmatceutical
state: Gangnam-gu
Study officials:
References:
Clinical trial NCT05690022: The Use of EndoFlip as a Clinical Tool for the Prediction of Postoperative GERD After Sleeve Gastrectomy
Official title: The Use of EndoFlip as a Clinical Tool for the Prediction of Postoperative GERD After Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux
Sleeve Gastrectomy
Bariatric Surgery Complication
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Université de Sherbrooke
First posted: 2023-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before/after study design
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to determine if preoperative EndoFlip measurement can effectively predict postoperative GERD-related quality of life and lower esophageal acid exposure.

Detailed description: Enrolled patients will be subjected to a pre-operative gastroscopy, 48-Hour Bravo pH study and EndoFlip. In addition, each patient will complete a GERD-related quality of life questionnaire (GERD-HRQL scale). One year after surgery, patients will undergo a follow up a gastroscopy, pH study, EndoFlip and the same quality of life questionnaire to predict the incidence of postoperative GERD and determine the effect of sleeve gastrectomy.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years old

Exclusion Criteria:

* Hiatal hernia \> 2 cm at preoperative gastroscopy
* Erosive esophagitis at preoperative gastroscopy
* Barrett's metaplasia/dysplasia at preoperative gastroscopy
* Revision surgery before the end of the study
* Pregnancy during the study period
* Actively bleeding esophageal varices

Primary outcomes:
measure: New-onset of gastroesophageal reflux disease
timeFrame: 12 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Université de Sherbrooke
name: François-Charles Malo
role: PRINCIPAL_INVESTIGATOR
References: