louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02242409: Study of Gemcitabine and Abraxane for Pancreas Cancer
Official title: A Phase II Study of Gemcitabine and Nanoparticle-Bound Paclitaxel as Second Line Therapy in Patients With Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Metastatic pancreatic cancer
Second Line treatment
Gemcitabine
Nab-paclitaxel
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting

Detailed description: This is an open label Phase II study to evaluate the clinical activity of the combination of gemcitabine and nab-paclitaxel (abraxane) as second line treatment in patients with metastatic pancreatic cancer who have received non-gemcitabine-based chemotherapy in the first line setting. All patients will receive both drugs on Days 1, 8, 15 every 28 days. The hypothesis is that this combination will have a 4-month progression free survival of 70% or higher.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic adenocarcinoma of the pancreas
* Progression on first line non-gemcitabine based therapy for metastatic or relapsed disease
* Radiographically measurable or evaluable disease
* Age \>/= 18 years
* ECOG performance status 0-2
* Adequate hepatic, bone marrow and renal function

Exclusion Criteria:

* Prior gemcitabine-based chemotherapy in the first line setting
* No active severe infection, or known chronic infection with HIV or hepatitis B virus
* No cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
* No women who are pregnant or breastfeeding, and no women of childbearing potential without using dual forms of contraception
* Patients with known CNS metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel
* Anticipated patient survival under 2 months

Primary outcomes:
measure: 4 month progression free survival
timeFrame: 2.5 years
Secondary outcomes:
measure: Disease control rate
timeFrame: 2.5 years
measure: Progression Free Survival
timeFrame: 2.5 years
measure: Overall Survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown Lombardi Comprehensive Cancer Center
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Michael Pishvaian, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01124409: Evaluation of 3DCRT Versus IGRT and Analysis of Early Response in Head and Neck Cancer.
Official title: Randomised Clinical Phase III Study of Radiotherapy Dose, Volume Evaluation for 3DCRT Versus IGRT and Analysis of Early Response in Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HEAD AND NECK CANCER
CARCINOMA OROPHARYNX
CARCINOMA PYRIFORM SINUS
CARCINOMA LARYNX
Keywords: IGRT
3DCRT
EPID
CBCT
HNSCC
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2010-05-17
Enrollment: 41
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: This study aims to study the impact image guided radiotherapy with Cone beam CT will have on the outcomes(toxicities and response) of head and neck cancer when compared to 3D conformal radiotherapy without CBCT based setup error verification.Also,the various dosimetric variations in Adaptive RT will be studied.

Detailed description: Aims and Objectives

1. To assess the patient's radiation dose planning for GTV, CTV and PTV for primary and nodal regions and derive comparison between IGRT and 3D-CRT.
2. To assess the dosimetric variation in different phases of adaptive RT due to changes in tumor shape and volume during the course of entire treatment in IGRT arm in head and neck cancer patients.
3. To evaluate the optimal setup correction methodology using planar (EPID) and volumetric images (CBCT) in HNSCC between 3D-CRT and IGRT treatment delivery respectively.
4. To compare the early tumour response and acute and chronic radiation morbidities between IGRT and 3D-CRT.

Eligibility criteria: Inclusion Criteria:

* Histopathologically proven cases of Carcinoma Oropharynx,Larynx,Hypopharynx, stages T1-4 N0-2a M0
* Informed Consent
* KPS score \> 70

Exclusion Criteria:

* Uncontrolled medical comorbidity
* Not ready for follow up
* Previous cancer directed therapy

Primary outcomes:
measure: compare the early tumour response between 3DCRT and IGRT in head and neck cancer.
timeFrame: Assessment at post RT week, 1 month after completion of RT and 6 month after completion of RT. Final assessment of last recruited patient is anticipated to be by AUGUST 2011
Secondary outcomes:
measure: To assess and compare early and late toxicities between 3DCRT and IGRT in head and neck cancer
timeFrame: assessment of acute and chronic toxicities of the last recruited patient anticipated to be by March 2011
measure: To find out the different doses received by target and organs at risk during the various phases of adaptive RT.
timeFrame: last measurement by AUG 2011
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
Study officials:
affiliation: All India Institute of Medical Sciences
name: BIDHU K MOHANTI, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06622109: A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Official title: PREVENAR 20 SUSPENSION LIQUID FOR INJECTION SPECIAL INVESTIGATION - Investigation in Infants Starting Vaccination at the Age of 2 Month, Inclusive, to 7 Months, Exclusive -
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 1100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants aged 2 months, inclusive, to 7 months, exclusive who PREVENAR 20 for the first time.

Brief summary: The purpose of this study is to learn about the safety of 20-valent Pneumococcal Conjugate Vaccine (PREVENAR 20) under actual clinical practice in Japan.

This study is seeking for infants aged between two months to six months who are vaccinated with PREVENAR 20 for the first time.

Infants aged between two months and six months are normally given four vaccinations. The first three vaccinations are called primary vaccinations and are given with an interval of one month between each vaccination. The fourth vaccination is called the booster and is given between 12 and 15 months of age.

Participants will take part in this study from the day of first vaccination to 28 days after fourth vaccination.

The side effects observed in the participants will be recorded and looked into.


Eligibility criteria: Inclusion Criteria:

1. Infants aged 2 months, inclusive, to 7 months, exclusive
2. Those without a history of pneumococcal vaccination including PREVENAR 20
3. Those who are expected to receive 4 doses
4. Those whose parent or legal guardian understands the details of the study and provides consent to provision of information collected in the study to third parties and use of the information for other purposes.

Exclusion Criteria:There are no exclusion criteria for this study.

Primary outcomes:
measure: Percentage of Participants Reporting Adverse Reactions(ADRs)
timeFrame: From the first day of each vaccination (1st-4th) up to 28 days after each vaccination (1st-4th).
measure: Percentage of Participants Reporting Serious Adverse Reactions (SADRs)
timeFrame: From the first day of 1st vaccination up to 28 days after 4th vaccination.
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06485609: Clinical Study of Radical Right Hemicolectomy Versus Radical Right Hemicolectomy Combined with Indocyanine Green Fluorescence Imaging Lymphatic Tracer Dissection for the Treatment of Right Colon Cancer
Official title: A Prospective, Randomized, Open, Parallel-controlled, Superiority Clinical Study of Radical Right Hemicolectomy Versus Radical Right Hemicolectomy Combined with Indocyanine Green Fluorescence Imaging Lymphatic Tracer Dissection for the Treatment of Right Colon Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 1200
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: The purpose of this study is to explore the clinical outcomes of indocyanine green fluorescence using in laparoscopic radical right hemicolectomy for right colon cancer（T1-T4a N+ M0）


Eligibility criteria: Inclusion Criteria:

* 1. Age between 18 and 75 years old 2. Confirmed adenocarcinoma cancer pathologically 3. Location of tumor: from the cecum to the right third of the transverse colon 4. CT showed right colon cancer: T1-T4a N+ M0 5. ASA scores I-III 6. ECOG (Eastern Cooperative Oncology Group) scale performance status of 0 or 1 7. Patient or family member, able to understand the study protocol and willing to participate in the study, providing written informed consent

Exclusion Criteria:

* 1. Simultaneous or heterochronic multiple primary colon cancer 2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery 3. Unsuitable for laparoscopic surgery (e.g., extensive adhesions due to previous major abdominal surgery; unsuitable for pneumoperitoneum for various reasons, etc.) 4. Pregnant or lactating women 5. Have a history of serious mental illness 6. History of iodine allergy 7. History of other malignant diseases within the last five years 8. History of prior neoadjuvant chemotherapy or radiation therapy 9. History of unstable angina or myocardial infarction within the last 6 months 10. History of continuous systemic corticosteroid use within one month

Primary outcomes:
measure: Disease-free survival rate
timeFrame: 3 years
Secondary outcomes:
measure: Number of lymph nodes cleared
timeFrame: Immediately after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
Study officials:
References:
Clinical trial NCT02151409: Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects
Official title: A Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Trial of Anti-C5aR Antibody (NNC 0151-0000-0000) Administered by i.v. Infusion or s.c. Injection in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation
Systemic Lupus Erythematosus
Rheumatoid Arthritis
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-05-30
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to develop a complement system targeted monoclonal antibody (mAb) to be used in treatment of subjects with chronic autoimmune diseases.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
* Body weight (BW) below or equal to 110.0 kg
* Body Mass Index (BMI) 20.0 - 27.0 kg/m\^2, both inclusive
* Good state of health: evidenced by medical history, physical examination and results of laboratory examinations

Exclusion Criteria:

* History of known or suspected cardiovascular diseases including: supine systolic blood pressure (BP) above or equal to 140 mmHg or below 90 mm Hg, diastolic BP above oe equal to 90 mm Hg or below 40 mm Hg, heart rate (HR) in supine position above 100 beats/minute or below 45 beats/minute
* Hepatic insufficiency: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above Upper Limit of Normal (ULN) (retesting is permitted within one week if first test is elevated but below 1.5 fold ULN)
* Renal insufficiency: Serum creatinine above ULN
* Positive for humane immunodeficiency virus (HIV) (by test)
* Positive for hepatitis B (HBV) or hepatitis C (HCV) (by test)

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: Week 0-10
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: The first-in-human trial of the humanised monoclonal antibody NNC 0151-0000-0000 blocking the C5a receptor (C5aR). EULAR (European League Against Rheumatism) 2009; Country: Denmark City: Copenhagen
Clinical trial NCT00000809: Safety and Effectiveness of Two Different Formulations of an HIV Vaccine in Infants Born to HIV-Infected Women
Official title: A Phase I Trial of the Safety and Immunogenicity of MN rsgp120/HIV-1 With the Adjuvants QS-21 and Alum Compared to MN rsgp120/HIV-1 and QS-21 in Infants Born to HIV-Infected Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: HIV Infections
HIV Seronegativity
Keywords: HIV Preventive Vaccine
HIV Therapeutic Vaccine
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the safety and effectiveness of two different formulations of an HIV vaccine in infants born to HIV-infected women.


Eligibility criteria: Inclusion Criteria

Infants may be eligible for this study if they:

* Are 1 to 3 days old.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01761409: Epidemiological Analysis on Endometrial Cancer in Guangdong Province of China
Official title: Epidemiological Analysis on Endometrial Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Cancer
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Sun Yet-Sen University Cancer Center
name: First People's Hospital of Foshan
name: First Affiliated Hospital, Sun Yat-Sen University
name: Meizhou People's Hospital
name: Jiangmen Central Hospital
name: Guangdong Provincial People's Hospital
name: Guangzhou Panyu Central Hospital
name: First People's Hospital, Shunde China
name: Yuebei People's Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First posted: 2013-01-04
Enrollment: 10000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who was diagnosed with endometrial carcinoma from 2000 to 2010 in Guangdong province of China

Brief summary: Endometrial cancer is one of the most common gynecological cancers, and the incidence increasing in the world. However, there isn't any large sample data of endometrial cancer reported in China. Thus Endometrial cancer project of Guangdong province conduct a large multicentre clinical investigation about endometrial cancer.

Detailed description: Endometrial cancer project of Guangdong province is mainly conducted by the Department of Gynecology of the Third Affiliated Hospital of Sun Yet-sen University, and other 62 major hospitals in Guangdong province participate in this project. In this large multicentre clinical investigation, the endometrial cancer database including more than 10,000 cases has been established. Further the investigators will demonstrate the epidemiological characteristics, etiology, risk factors, clinical treatment and prognosis of endometrial cancer.

Eligibility criteria: Inclusion Criteria:

* patients who was diagnosed with endometrial carcinoma from 2000 to 2010 in Guangdong province of China;
* patients with intact clinical and pathological information

Exclusion Criteria:

* not included in the inclusion criteria

Primary outcomes:
measure: survival rate
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital,Sun Yet-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT03942809: Clinical Evaluation of the Revised iLTS-D2
Official title: Clinical Evaluation of the Revised iLTS-D2 in Effectivity and Practicability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management
Keywords: Airway Morbidity
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A interventional, non-randomized, controlled study to evaluate the revised iLTS-D2 in anesthetized patients.

Detailed description: The revised Intubation laryngeal tube - disposable (iLTS-D) is a refined laryngeal tube, which allows a secondary intubation over the inserted laryngeal tube. The present study should reveal the effectiveness and practicability in anesthetized patients in the operation room.

Eligibility criteria: Inclusion Criteria:

* elective surgery patients under general Anesthesia

Exclusion Criteria:

* Age \<18 years
* Existing pregnancy
* Lack of consent
* inability to consent
* emergency patients

Primary outcomes:
measure: Insertion time LT
timeFrame: in 30 seconds
Secondary outcomes:
measure: Insertion time ET
timeFrame: in 60 seconds
measure: Rate of successful Intubation attempts
timeFrame: through study completion, an average of 120 seconds
measure: hemodynamics MAP
timeFrame: through study completion, an average of 360 seconds
measure: hemodynamics Freq
timeFrame: through study completion, an average of 360 seconds
measure: hemodynamics rO2
timeFrame: through study completion, an average of 360 seconds
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
state: Rhineland-Palatinate
Study officials:
affiliation: University Medical Center Mainz
name: Marc Kriege, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05815407: Expressiona and Diagnostic Potential of miRNAs in NSCLC
Official title: The Expression Profiling of Serum miRNAs (106b-5p, 601, and 760) in Non-small Cell Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, Cairo University, Egypt
First posted: 2023-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Case-control

Brief summary: Its to explore the expression pattern, diagnostic and prognostic potentials of miRs (106b-5p, 601 and 760) in serum of NSCLC patients

Detailed description: A retrospective observational study on NSCLC patients, to determine the serum expression levels if some miRNAs in NSCLC patients and to find if having proper diagnostic and prognostic values in early disease detection, and/or staging.

Eligibility criteria: Inclusion Criteria:

* First time and recently diagnosed NSCLC patient

Exclusion Criteria:

* Recurrent NSCLC
* Start of chemotherapy, radiotherapy or surgical intervention
* Previous treatment
* Cancer history

Primary outcomes:
measure: Determination of the expression
timeFrame: By the end of the study (September 2022)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt
Study officials:
References:
Clinical trial NCT01461707: The MOTHER (Mobile Technologies to Help Enhancing Regular Physical Activity) Trial for Pregnant Women
Official title: A Pilot Study of a Mobile Phone-Based Physical Activity Program in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Cellular phone
exercise
pregnant women
obesity
overweight
physical activity
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-10-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Obesity among women of childbearing age and excessive weight gain during pregnancy are prevalent and steadily increasing health care issues. Regular physical activity is recommended to maintain healthy weight gain for pregnant women, however, a majority of pregnant women are sedentary. The investigators proposed to conduct a pilot study to estimate the potential efficacy of a mobile phone based physical activity intervention in 30 physically inactive pregnant women.


Eligibility criteria: Inclusion Criteria:

* pregnant, gestational week (10-20 weeks)
* pre-pregnancy BMI ≥ 18.5 kg•m2
* physically inactive at work and during leisure time
* intent to be physically active
* access to a home telephone or a mobile phone
* have a personal computer access
* ability to communicate (speak and read) in English.

Exclusion Criteria:

* known medical or obstetric complication that restricts physical activity
* history of eating disorders
* current participation in lifestyle modification programs
* history of bariatric surgery.

Primary outcomes:
measure: Physical Activity Monitor Measured Steps
timeFrame: 12 weeks
Secondary outcomes:
measure: 7-Day Physical Activity Recall
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: JiWon Choi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi J, Lee JH, Vittinghoff E, Fukuoka Y. mHealth Physical Activity Intervention: A Randomized Pilot Study in Physically Inactive Pregnant Women. Matern Child Health J. 2016 May;20(5):1091-101. doi: 10.1007/s10995-015-1895-7.