louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00377936: EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
Official title: A Controlled, Randomized, Open Label Phase II Trial to Evaluate Safety and Efficacy of a 1st Line Combination Treatment With Weekly Infusions of Gemcitabine and Twice Weekly Administration of Lipid Complexed Paclitaxel (EndoTAG-1) in Three Dose Levels Compared With Gemcitabine Monotherapy in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma
Metastasis
Pancreas Neoplasms
Keywords: Adenocarcinoma of the pancreas
Locally advanced
Metastatic
Lead sponsor: MediGene
Sponsor class: INDUSTRY
First posted: 2006-09-19
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.


Eligibility criteria: Inclusion Criteria:

* Inoperable adenocarcinoma of the pancreas
* Histologic or cytologic confirmation
* At least 18 years of age

Exclusion Criteria:

* Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment
* Major surgery within 4 weeks prior to enrollment
* Major cardiovascular disease

Primary outcomes:
measure: Progression free survival
timeFrame: Median
measure: 6-month-survival-rate
timeFrame: 6 Months
measure: Overall survival
timeFrame: Median
Secondary outcomes:
measure: Incidence and percentage of patients with Adverse Events
timeFrame: 28 days after last patient out
measure: Number of clinically significant abnormal laboratory values
timeFrame: Last patient out
Other outcomes:
Locations:
city: Prague
country: Czech Republic
city: Budapest
country: Hungary
city: Kiev
country: Ukraine
Study officials:
affiliation: Universitätsklinikum Mannheim
name: Matthias Löhr, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01224236: Randomized Trial of Iron Supplementation to Prevent Anemia in Very-low-birth-weight Infants
Official title: Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight (VLBW) Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Anemia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2010-10-19
Enrollment: 150
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if iron supplementation in addition to routine iron intake decreases the risk of developing anemia in preterm infants.

Detailed description: Objective was to determine if iron supplementation of 2 mg/kg per day, in addition to routine iron-fortified formula or mother's milk, increased the hematocrit (Hct) at 36 weeks' postmenstrual age (PMA).

All infants have a decline in hemoglobin(Hgb) after birth because of increasing PaO2 and Hgb saturation after birth. In very low birth weight (VLBW) infants (birth weight ,1500 g), the nadir at 1 to 3 months after birth is lower than in term infants because of (1) greater phlebotomy losses for blood tests, (2) shortened red blood cell survival, and (3)rapid growth.

VLBW infants may be at increased risk of developing iron deficiency anemia because of (1) low iron stores at birth, (2) rapid depletion of iron stores owing to phlebotomy losses, and (3) inability to regulate iron absorption by the gastrointestinal tract.

Eligibility criteria: Inclusion Criteria:

1. birth weight: \< 1500 grams
2. Tolerating iron fortified preterm formula or fortified breast milk at 120cc/kg/day by 8 weeks of age
3. ≤32 weeks adjusted post-menstrual age at the time of enrollment

Exclusion Criteria:

1. cyanotic heart disease
2. bowel resection prior to enrollment

Primary outcomes:
measure: Hematocrit (Hct)
timeFrame: 36 weeks postmenstrual age (PMA)
Secondary outcomes:
measure: Transfusions
timeFrame: enrollment to 36 weeks postmenstrual age (PMA)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Children's Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Kennedy Kathleen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taylor TA, Kennedy KA. Randomized trial of iron supplementation versus routine iron intake in VLBW infants. Pediatrics. 2013 Feb;131(2):e433-8. doi: 10.1542/peds.2012-1822. Epub 2013 Jan 21.
Clinical trial NCT00002036: Phase I Safety Study of Anti-HIV Immune Serum Globulin (Human)
Official title: Phase I Safety Study of Anti-HIV Immune Serum Globulin (Human)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Immunization, Passive
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To investigate the potential benefit of providing passive immunity with hyperimmune anti-HIV human serum.


Eligibility criteria: Inclusion Criteria

Patients must have:

* Proof of HIV infection.
* Diagnosis of asymptomatic HIV infection or early AIDS related complex (ARC) with no zidovudine (AZT) or other anti-HIV therapy. OR a diagnosis of AIDS and = or \> 3 months of AZT therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* HIV-induced neurological disease.
* IgA negative.

Concurrent Medication:

Excluded:

* Immunomodulating agents.
* Steroids.
* Interferons.

Patients with the following are excluded:

* Active substance abuse.
* Use of immunomodulating drugs such as steroids or interferons.
* HIV-induced neurological disease.
* IgA negative.

Required with a diagnosis of AIDS:

* = or \> 3 months of zidovudine (AZT) therapy.

Active substance abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Univ of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT06164236: Study of Predictors of Failure of Sulprostone Treatment in Postpartum Hemorrhage
Official title: Study of Predictors of Failure of Sulprostone Treatment in Postpartum Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Keywords: Postpartum haemorrhage
Maternal morbidity
Oxytocin
Sulprostone
Uterine Hemorrhage
Obstetric Labor Complications
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult person (≥18 years old) who gave birth at HUS or at Poissy Saint-Germain-en Laye university hospital between 01/01/2019 and 12/31/2020 and having presented a postpartum hemorrhage treated with Sulprostone

Brief summary: The investigators wish to identify potential factors predicting failure of second-line drug treatment (sulproston (Nalador®)): risk factors and factors linked to a failure to take initial care for PPH.

A better understanding of the aggravating factors of HPP and more particularly the factors inherent to the initial care would make it possible to think of ways to improve practices.


Eligibility criteria: Inclusion Criteria:

* Major subject (≥18 years old)
* Subject having given birth at HUS or CHU Poissy Saint-Germain-en Laye between 01/01/2019 and 31/12/2020
* Subject having presented a postpartum haemorrhage treated with Sulprostone
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice

Primary outcomes:
measure: This a rétrospective study trayning to identify a potential predictors of failure of second-line drug treatment in the case of severe postpartum hemorrhage
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: École de sages-femmes de Strasbourg
state: Starsbourg
Study officials:
References:
Clinical trial NCT00036036: Study of CP-461 in Patients With Advanced Renal Cell Cancer
Official title: Phase II Study of CP-461 in Patients With Advanced Renal Cell Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Keywords: renal
renal cell cancer
renal cell carcinoma
kidney cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: OSI Pharmaceuticals
First posted: 2002-05-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of CP-461 given twice-daily orally in locally advanced or metastatic renal cell cancer and to evaluate the safety profile of CP-461 in this patient population.


Eligibility criteria: Inclusion Criteria:

1. Measurable metastatic or locally advanced disease.
2. Histologically confirmed renal cell cancer.
3. No radiotherapy within 4 weeks prior to entering the study. No more than 1 prior systemic therapy for advanced disease. Prior adjuvant systemic therapy is allowed. Patients must have fully recovered from the acute effects of prior therapy.
4. Expected remaining life span \> or = three months.
5. ECOG performance status 0-2.
6. \> or = 18 years of legal age.
7. Male patients, or non-pregnant and non-lactating female patients who are either using adequate birth control, surgically sterile or post-menopausal.
8. Negative serum pregnancy test, if fertile female.
9. Willingness and ability to sign an informed consent document.

Exclusion Criteria:

1. Uncontrolled or symptomatic brain metastases.
2. Use of an investigational medication or device within one month of initiating study therapy.
3. Absolute granulocyte count \< or = 1500/mm3; Platelet count \< or = 100,000/mm3; total serum bilirubin above the upper limit of normal; serum creatinine \> or = 2.2 mg/dL; AST/ALT \> 2.5 ULN.
4. Any condition or any medication which may interfere with the conduct of the study.
5. Current active malignancy other than renal cell cancer.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
Study officials:
References:
Clinical trial NCT01967836: Glad Press 'n Seal® as a Temporary Moisture Barrier to Central Lines in Ambulatory Patients
Official title: Glad Press 'n Seal® as a Temporary Moisture Barrier to Central Lines in Ambulatory Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-related Problem/Condition
Ambulatory Care
Keywords: Invasive Line
IV Dressing protection
Hygiene
Oncology
Ambulatory Care
Lead sponsor: Wheaton Franciscan Healthcare
Sponsor class: OTHER
First posted: 2013-10-23
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see if Glad Press 'n Seal works as a moisture barrier for central line that is left in place during ambulatory oncology clinical care.

Detailed description: Enrolled subjects will be instructed on the application of the Glad Press 'n Seal product to their IV dressing for use during a shower activity. Practice with application and removal of the product will be supervised by the PI or RA. Questions will be answered and a commercially purchased box of the investigational product will be given to the subject for home use.

Eligibility criteria: Inclusion Criteria:

* Subjects requiring mediport or peripherally inserted central venous catheter line access for 3-5 days
* Able to read and write English
* Use showering as a means of home hygiene

Exclusion Criteria:

* Subjects with eczema/psoriasis at the line insertion area
* Subjects with active line/site irritation/infection
* Subjects on chemotherapy protocols including anti-epidermal growth factor receptor drugs (cetuximab, panitumumab) or ipilimumab as there is a high incidence of skin rash as a side effect of these medications
* Patients who do not intend to shower as a means of home hygiene

Primary outcomes:
measure: Patient Subject Questionnaire Post Shower Evaluation
timeFrame: complete one evaluation after each shower when using product
measure: Patient Satisfaction Mean on a 0-10 Likert Scale on the Use of Glad Press 'n Seal During Showering. 40 Subjects Reports.
timeFrame: Reported afer each subject showering survey completion
Secondary outcomes:
measure: Clinic Nurse Observation of Subjects, Who Used Intervention Device, at the Next Clinic Visit
timeFrame: Inspection of central line site and dressing upon return to schduled clinic visit up to 30 days
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Rieman Cancer Center
state: Wisconsin
city: MIlwaukee
country: United States
facility: Wheaton Franciscan Healthcare-St Joseph campus
state: Wisconsin
city: Milwaukee
country: United States
facility: WFH-St. Francis
state: Wisconsin
city: Wauwatosa
country: United States
facility: Wheaton Franciscan - Wauwatosa Campus
state: Wisconsin
Study officials:
affiliation: Wheaton Franciscan Healthcare
name: Maureen T Greene, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05395936: Mastectomy Flap Temperature Study
Official title: Mastectomy Flap Temperature and Clinical Implications
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Mastectomy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-05-27
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to measure tissue temperatures and generate a prospective database of participants undergoing mastectomy with or without breast reconstruction at Wake Forest Baptist Hospital (WFBH) in order to enable and facilitate the evaluation of important and novel research questions - and quality improvement (QI) ideas/objectives - that may improve the care of breast surgery patients.

Detailed description: Primary Objective(s)

* Quantify the proportion of eligible women approached who consent to intraoperative (pre and post mastectomy) measurement of mastectomy flap temperatures in each of 4 quadrants of each relevant breast (i.e., unilateral or bilateral procedure).
* Quantify the proportion of patients upon whom the surgical team is able to obtain intraoperative flap measurements from each of 4 quadrants on each relevant breast pre- and post-mastectomy and pre-implant.

Secondary Objective: To measure mastectomy flap temperatures in 4 quadrants pre-mastectomy, following mastectomy, and pre-implant, and compare average flap temperature to average core body temperature.

Eligibility criteria: Inclusion Criteria:

* Scheduled for unilateral or bilateral mastectomy with implant based breast reconstruction within the Wake Forest Baptist Health System.
* Aged 18 or older.
* Ability to understand an IRB-approved informed consent document (either directly or via a legally authorized representative).

Exclusion Criteria: Those who are male.

Primary outcomes:
measure: Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During Surgery
timeFrame: 90 days post surgery
measure: Number of Women Having All Relevant Flap Temperatures Measured
timeFrame: 90 days post surgery
Secondary outcomes:
measure: Change in Mastectomy Flap Temperatures and Core Body Temperatures
timeFrame: At pre-mastectomy (baseline), pre-implant (before surgery) and post mastectomy (up to 90 days post surgery)
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Health Sciences
name: Adam Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00146536: Upstaging of ALH/LCIS Found on Core Biopsy Based on Subsequent Excisional Biopsy
Official title: The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma, DCIS, or Atypical Ductal Hyperplasia (ADH) in Patients Diagnosed With Lobular Neoplasia of the Breast by Core Needle Biopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: ALH
LCIS
DCIS
adjacent ipsilateral infiltrating carcinoma
core needle biopsy
Lobular neoplasia of the breast
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Translational Breast Cancer Research Consortium
name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
First posted: 2005-09-07
Enrollment: 78
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have ALH/LCIS detected on a needle biospy of the breast

Brief summary: The goal of this study is to determine how often patients who have atypical lobular hyperplasia (ALH) or lobular carcinoma in situ (LCIS) on core needle biopsy of an imaging (found by mammogram or breast ultrasound) abnormality will have associated breast cancer at surgical removal of the area.

Detailed description: Patients will undergo a breast biopsy at which the area found to be ALH or LCIS on core biopsy will be removed surgically through a small incision in the breast.

* The surgical biopsy specimen will be carefully examined by a pathologist, and may be useful in guiding further therapy if needed.
* In the future, tissue from the surgical biopsy may be used to study genetic changes that may be responsible for cancer formation and prevention. The tissue will be kept for future research for up to 10 years.

Eligibility criteria: Inclusion Criteria:

* Women 20 years of age or older
* Imaging abnormality necessitating a core needle biopsy
* Core needle biopsy revealing ALH or LCIS
* Patients may have a history of fibroadenoma and/or proliferative breast lesions with atypia

Exclusion Criteria:

* History and/or concomitant diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS)
* A palpable abnormality diagnosed by core needle biopsy to be ALH or LCIS
* Received tamoxifen in the past

Primary outcomes:
measure: Rate of upstaging from Lobular Neoplasia on core biopsy to invasive breast cancer or ductal carcinoma in situ on excisional biopsy
timeFrame: Concomittant
Secondary outcomes:
measure: Factors which predict for upstaging from Lobular Neoplasia on core biopsy to invasive breast carcinoma or ductal carcinoma in situ
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Faina Nakhlis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00935636: An Evaluation of Efficacy of the GlideScope Cobalt Video Baton for Intubation on Children Weighing Less Than 10 Kilograms
Official title: An Evaluation of Efficacy of the GlideScope Cobalt Video Baton for Intubation on Children Weighing Less Than 10 Kilograms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation
Keywords: Intubation
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2009-07-09
Enrollment: 200
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates and infants requiring endotracheal intubation under 10 kilograms and in which the attending anesthesiologist decided to use the CGS-CVB will be included in this observational study.

Brief summary: The purpose of this study is to collect relevant airway data using the GlideScope Cobalt Video Baton 1 and 2 for intubation in a large cohort of neonates and infants weighing 10 kg or less.

Detailed description: Neonates and infants requiring endotracheal intubation and in which the attending anesthesiologist decided to use the CGS-CVB will be included in this observational study. Data will be collected by one of the investigators or the research assistant/coordinator and recorded on a data sheet The data from these forms will be then entered by the investigator or research assistant/coordinator into a database maintained only for this study.

The decision of using the GS-CVB is at the discretion of the attending anesthesiologist. Consequently if consent would be required the anesthesiologist might feel compelled or biased to use the device against his will. This will also require that all possible patients's should be consented which will put a serious strain on the study personal.

Eligibility criteria: Inclusion Criteria:

* Neonates, infants and children scheduled for surgical procedures under general anesthesia and requiring endotracheal intubation
* Patients age 0 - 2 years
* Weight up to 10 kg
* American Society of Anesthesiologists physical status I-III

Exclusion Criteria:

* Patients at risk of pulmonary aspiration,
* Increased intracranial pressure
* Those with congenital cardiac diseases or
* Those with hemodynamic instability

Primary outcomes:
measure: Time to intubation
timeFrame: From the time the ETT enters the mouth until end-tidal carbon dioxide is detected on the monitor screen
Secondary outcomes:
measure: The time to laryngoscopic views, number of attempts, and the success rate
timeFrame: from the time the device enters the mouth until the best view is acknowledged.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Chlidren's Medical Center Dallas
state: Texas
Study officials:
affiliation: UT Southwestern
name: Peter Szmuk, MD
role: PRINCIPAL_INVESTIGATOR
References: