louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00543907: Outcomes of a Deep Inferior Epigastric Perforator Flap Program
Official title: Outcomes of a Deep Inferior Epigastric Perforator Flap Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast reconstruction
DIEP flap
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2007-10-15
Enrollment: 977
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women who have undergone mastectomy for breast cancer between 1999 and 2008 at the BIDMC.

Brief summary: The purpose of this study is to analyze an institution's experience with starting a subspecialized DIEP flap program.

Detailed description: The purpose of this study is to analyze an institution's experience with starting a subspecialized DIEP flap program and to determine whether other hospitals would benefit from instituting a similar program. Prior studies have compared the outcome from a DIEP flap program with that of TRAM flaps within the same center. Other studies have calculated the cost of a DIEP flap and its complication rate. However, no one has examined the overall effects of a subspecialized reconstruction program and its impact on a health center. In this study, we will determine if the institutionalization of a DIEP flap program has increased our center's rate of breast reconstruction, as well as evaluate its outcomes and overall financial viability.

Eligibility criteria: Inclusion Criteria:

* Intraductal carcinoma
* Lobular carcinoma
* Infiltrating ductal carcinoma
* Paget's disease
* BRCA positive

Exclusion Criteria:

* Inflammatory carcinoma of the breast

Primary outcomes:
measure: complication rate
timeFrame: 6 years
Secondary outcomes:
measure: reconstruction rate
timeFrame: 6 years
measure: patient satisfaction
timeFrame: 6 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Bernard T Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00316407: Lapatinib/Carboplatin/Paclitaxel in Previously Treated Ovarian or Breast Cancer Patients
Official title: Phase I/II Lapatinib Plus Carboplatin and Paclitaxel in Stage III or IV Relapsed Ovarian or Stage IV Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ovarian Epithelial Cancer Stage III
Stage IV Ovarian Cancer
Stage IV Breast Cancer
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2006-04-20
Enrollment: 30
Sex: FEMALE
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 effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.

Detailed description: The MTD was found in the phase I portion of this study to be oral lapatinib 1000 mg per day for each 4 week cycle and paclitaxel 60 mg/m2 weekly x 3 of a 4 week cycle and carboplatin AUC 2 weekly x 3 of a 4 week cycle.

Eligibility criteria: Inclusion Criteria:

* Relapsed (Stage III or IV) ovarian, primary peritoneal, fallopian tube carcinoma patients.
* Stage IV metastatic breast cancer patients who have failed no more than four previous chemotherapies for Stage IV disease.
* Ability to swallow and retain oral medications.
* Measurable disease

Exclusion Criteria:

* Treatment with previous weekly carboplatin and paclitaxel.
* No prior treatment with erbB targeting therapies such as erlotinib, gefitinib and cetuximab.
* No concomitant requirement for medication classification as CYP3A4 inducers or inhibitors.

Primary outcomes:
measure: Toxicity
timeFrame: 1 year
Secondary outcomes:
measure: Objective response (PR or CR)
timeFrame: 1 year
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Seattle
country: United States
facility: Swedish Medical Center Cancer Institute
state: Washington
Study officials:
affiliation: Swedish Medical Center Cancer Institute
name: Saul Rivkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06842407: Novel Targets for the Development of Monoclonal Antibodies for Immunotherapy)
Official title: Nuovi Bersagli Per lo Sviluppo di Anticorpi Monoclonali Per Immunoterapia - (Novel Targets for the Development of Monoclonal Antibodies for Immunotherapy)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Donors
Lead sponsor: Checkmab S.r.l.
Sponsor class: INDUSTRY
Collaborators: name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
First posted: 2025-02-24
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects

Brief summary: The first objective of the project consists in the preclinical validation of new possible molecular targets associated with intratumoral T regulatory cells. The second objective consists in the selection of monoclonal antibodies with therapeutic potential, specific for the selected targets.


Eligibility criteria: Inclusion Criteria:

* blood donors
* age of 18 years or more
* able to sign informed consent

Exclusion Criteria:

* age below 18 years
* Positive for HIV, HCV, HBV
* not suitable for blood donation
* not able to understand or sign informed consent

Primary outcomes:
measure: Validation of molecular targets for immunotherapy
timeFrame: 04.2023-06.2026
measure: Selection of therapeutic antibodies
timeFrame: 04.2023-06.2026
Secondary outcomes:
measure: Set up of immunological assays to adress monoclonal antibodies mechanism of action
timeFrame: 04.2023-06.2026
Other outcomes:
Locations:
city: Milan
country: Italy
facility: S.C. Medicina Trasfusionale - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
References:
Clinical trial NCT00204607: Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial in Melanoma Patients
Official title: Induction of Specific Immune Responses Against Melanoma-Associated Antigens in Vivo by Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malignant Melanoma
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen

Detailed description: vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen. Antigens used are Melan-A, Mage-A1, Mage-A3, Survivin, GP100 and Tyrosinase. GM-CSF is used as an adjuvans. Phase I/II clinical trial to analyse safety and immune respones in stage III/IV melanoma patients.

Eligibility criteria: Inclusion Criteria:

* stage III/IV
* fresh frozen tumor-tissue
* age 18-75
* informed consent given
* Karnofsky \>= 70%

Exclusion Criteria:

* systemic glucocorticoids
* brain metestasis
* other malignancies

Primary outcomes:
measure: toxicity
measure: immune response
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department of Dermatology, University of Tübingen
Study officials:
affiliation: University of Tuebingen, Department of dermatology
name: Claus Garbe, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weide B, Pascolo S, Scheel B, Derhovanessian E, Pflugfelder A, Eigentler TK, Pawelec G, Hoerr I, Rammensee HG, Garbe C. Direct injection of protamine-protected mRNA: results of a phase 1/2 vaccination trial in metastatic melanoma patients. J Immunother. 2009 Jun;32(5):498-507. doi: 10.1097/CJI.0b013e3181a00068.
Clinical trial NCT04610307: EFFECT OF BUFFERED LOCAL ANESTHESIA ON PAIN IN ARETERIOVENOUS FISTULA
Official title: EFFECT OF BUFFERED LOCAL ANESTHESIA ON PAIN DURING ARTERIOVEONUS FISTULA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Procedural
Pain, Postoperative
Satisfaction, Patient
Lead sponsor: Combined Military Hospital, Pakistan
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pain and satisfaction score will be assessed at the end of surgery and compared in either of two groups

Detailed description: All patients meeting inclusion criteria will be randomly enrolled in two groups. Intervention group will receive buffered lignocaine . at the end of procedure data will be recorded regarding pain VASscore and satisfaction score

Eligibility criteria: Inclusion Criteria:

* ASA I to III
* Brachiocephalic arteriovenous fistula
* Radiocephalic arteriovenous fistula

Exclusion Criteria:

* basiic vein transposition
* redo surgery emergency surgery
* failure to understand the questionnnare

Primary outcomes:
measure: pain score
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Combined Military Hospital
Study officials:
References:
Clinical trial NCT03796988: Autologous Regeneration of Tissue (ART) for Wound Healing
Official title: Autologous Regeneration of Tissue (ART) for Wound Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound of Skin
Keywords: Chronic Wound
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Medline Industries
First posted: 2019-01-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to learn about a new device, Autologous Regeneration of Tissue (ART), for collecting skin grafts from participant's own skin.


Eligibility criteria: Inclusion Criteria:

* Adults from 18 to 90 years of age.
* Patients that have a chronic wound in any area of the body defined as having been present for at least 30 days of duration.
* Able and willing to give consent for the study.

Exclusion Criteria:

* Pregnant women (Urine hCG test will be performed at baseline on women of child bearing potential).
* Adults unable to consent.
* Prisoners.
* Subjects requiring concurrent systemic antimicrobials during the study period for any infection.
* Subjects with leg lesions and clinically significant and unreconstructed peripheral arterial disease.
* Subjects who are receiving immunosuppressive agents, radiation therapy, or cytotoxic agents.
* Subjects who require treatment for a primary or metastatic malignancy (other than squamous or basal cell carcinoma of the skin).
* Subjects with other conditions considered by the investigator to be reasons for disqualification that may jeopardize subject safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance).

Primary outcomes:
measure: Change of Pain on Harvesting of Skin at Donor Site.
timeFrame: Baseline, Day 56
measure: Time to Healing of Donor Sites
timeFrame: Up to Day 56
Secondary outcomes:
measure: Wound Healing of Recipient Site
timeFrame: Up to Day 56
measure: Histologic Evaluation
timeFrame: Up to Day 56
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Hadar Lev-Tov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01629888: A Clinical Study for Evaluating the Safety of Excessive Consumption of a Plant Sterol-enriched Yoghurt Drink
Official title: A Clinical Study for Evaluating the Safety of Excessive Consumption of a Plant Sterol-enriched Yoghurt Drink
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Mild Hypercholesterolemia
Keywords: Plant sterol
Hypercholesterolemia
dairy
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to investigate the safety of consumption of three times the standard dose of a yoghurt drink enriched with 1600 mg of plant sterols.


Eligibility criteria: Inclusion Criteria:

* male/female subjects,
* aged 20-65 years old,
* triglycerides (TG) levels under 400 mg/dL,
* total cholesterol plasma level under 240 mg/dL (with half the subjects at entry under 200 mg/dL),
* LDL-cholesterol plasma level under 160 mg/dL (with half the subjects at entry under 120 mg/dL),
* non diabetic and non hypertensive,
* accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (Japan Atherosclerosis Society guidelines),
* effective contraceptive methods used for female subjects,
* having given written consent to take part in the study

Exclusion Criteria:

* subjects with sitosterolemia,
* subjects with 200 ml of blood taken within the past month or 400 ml or more within the past 3 months,
* taking any hypocholesterolemic treatment,
* presenting known allergy or hypersensitivity to plant sterols,
* dairy products and lactose, subject with heavy alcohol intake (\> 60g/day),
* receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
* subjects receiving a transplant or under immunosuppressor treatment,
* receiving treatment for any serious pathology.
* for female subject:

  * pregnancy,
  * breast feeding or
  * intention to be pregnant during the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Senri Chuo Ekimae Clinic
Study officials:
References:
Clinical trial NCT01287988: Follow-up Study to Assess Visual Function in Subset of Patients Who Have Previously Participated in the TG-MV-006 and TG-MV-007 Ocriplasmin Studies
Official title: Follow-up Study to Assess Visual Function in Subset of Patients Who Have Previously Participated in the TG-MV-006 and TG-MV-007 Ocriplasmin Studies.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Vitreomacular Adhesion
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
First posted: 2011-02-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have previously participated in either of the ocriplasmin Phase III studies (TG-MV-006 or TG-MV-007)

Brief summary: The primary objective of this study is to assess visual function in up to 44 patients who have previously participated in either of the placebo controlled, ocriplasmin Phase III studies (TG-MV-006 or TG-MV-007).

Detailed description: Non-interventional follow up study consisting of 1 patient visit to perform assessments to assess long term visual function

Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from the patient prior to inclusion in the follow-up study
* Previous participation in either of the placebo controlled, ocriplasmin Phase III studies (TG-MV-006 or TG-MV-007)

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Evidence of clinically significant abnormality in visual function, including Best Corrected Visual Acuity (BCVA), Spectral Domain Optical Coherence Tomography (SD-OCT) abnormality, and/or Electroretinography (ERG) abnormality
timeFrame: Visit 1
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Retinal Consultants of Houston
state: Texas
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen K.U. Leuven
Study officials:
References:
Clinical trial NCT03020888: Magseed Magnetic Marker Localization
Official title: A Prospective, Open Label, Post Marketing Study of Magseed and Sentimag in Patients Undergoing Surgical Excision of a Breast Lesion That Requires Preoperative Radiographic Localization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorders of Breast
Breast Lesions
Lead sponsor: Endomagnetics Ltd.
Sponsor class: INDUSTRY
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2017-01-13
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this post-marketing study is to provide prospective evidence that the Magseed and Sentimag® is effective for lesion localization in patients undergoing surgical excision of a breast lesion and to summarize measures of product safety and performance.

Detailed description: This is a post-market, prospective, open label, single arm study of Magseed and Sentimag in patients undergoing surgical excision of a breast lesion.

Subjects will have the Magseed marker deployed under imaging guidance up to thirty days prior to surgery.

The Magseed marker will be localized using the Sentimag system during surgery and removed with the lesion.

After the lumpectomy procedure, subjects will be evaluated for safety and patient reported outcomes.

Eligibility criteria: Inclusion Criteria:

* Subjects with a breast lesion requiring image-guided localization prior to excision.
* Subjects aged 18 years or more at the time of consent.

Exclusion Criteria:

* The subject is pregnant or lactating.
* Subject has pacemaker or other implantable device in the chest wall.
* Subject has current active infection at the implantation site in the breast (per investigatordiscretion)

Primary outcomes:
measure: Percent of Participants With Retrieval of Index Lesion and Magseed
timeFrame: Time of surgery on average 16 minutes
Secondary outcomes:
measure: Number of Device Related Adverse Events
timeFrame: 8 weeks
measure: Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy
timeFrame: At the time of marker deployment on average 8.39 minutes
measure: Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion
timeFrame: At time of marker deployment on average 8.39 minutes
measure: Percentage of Participants With Re-excision
timeFrame: During surgery on average 16 minutes
measure: Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy
timeFrame: At time of surgery on average 16 minutes
measure: Surgical Localization - Duration of Localization
timeFrame: At time of surgery on average 16 minutes
measure: Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy
timeFrame: On the day of surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: MD Anderson
name: Kelly Hunt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02404688: Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition
Official title: Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Cannabis
Alcohol Effect
Driving Under the Influence of Alcohol and Other Drugs
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

Detailed description: To study the effects of ethanol clamped at BAC 0.04% and THC (1.05 mg in a 70 kg individual) on driving.

Eligibility criteria: Inclusion Criteria:

* Males or females 21 to 55 years of age (extremes included).
* Exposed to cannabis at least once.
* Exposed to alcohol at least once.
* Able to provide informed consent.

Exclusion Criteria:

* Cannabis naive.
* Alcohol naive.
* Positive pregnancy screen
* Hearing deficits.

Primary outcomes:
measure: Road Tracking Error
timeFrame: baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion
Secondary outcomes:
measure: Biphasic Alcohol Effects Scale (BAES)
timeFrame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol and THC infusion
measure: Visual Analog Scale (VAS)
timeFrame: baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion
measure: Cognitive Test Battery
timeFrame: +40 mins after start of alcohol and THC infusion
measure: Willingness to Drive Scale
timeFrame: baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion
measure: Number of Joints Scale
timeFrame: baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion
measure: Number of Drinks Scale
timeFrame: baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Biological Studies Unit, VA Connecticut Healthcare System
state: Connecticut
Study officials:
References: