louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03492996: A Mass Balance Study of LCB01-0371 After a Single Oral LCB01-0371 Dose With a [14C]LCB01-0371-microtrace
Official title: A Mass Balance Study to Investigate the Absorption, Metabolism, Excretion of LCB01-0371 After a Single Oral LCB01-0371 Dose With a [14C]LCB01-0371- Microtracer Dose in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LigaChem Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-10
Enrollment: 6
Sex: MALE
Minimum age (years): 19
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objectives of the study are:

• To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a \[14C\]-LCB01-0371-tracer dose to healthy subjects

Detailed description: This is a single-center, open-label, non-randomized, one-sequence, one-period, single arm study in healthy male subjects. A total of 6 subjects will be enrolled in the study, and a minimum of 4 evaluable subjects are considered sufficient. An evaluable subject is defined as a subject who has provided whole blood, plasma, exhalation and excreta samples sufficient for evaluation of the primary objectives. Study subjects will be screened for eligibility to participate in the study within 28 days before dosing.

Eligibility criteria: Inclusion Criteria:

1. Healthy male adults aged 19 to 45 (inclusive) years
2. Body weight at least 55 kg and calculated Body Mass Index (BMI) ranging from 18.0 to 25.0 kg/m2
3. Subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form
4. Subjects who were deemed as eligible subjects by investigators on their physical examination, laboratory findings, and medical examination by interview.
5. Subject who were not to have a history of drug hypersensitivity or allergic reactions related to antibiotics, etc

Exclusion Criteria:

1. Subjects who had a clinically significant disease or a past history of disease
2. Subjects who had a past history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or surgery (excluding simple appendectomy or hernia surgery) that may have affected to absorption for the study drug.
3. Subjects who had the following laboratory test results at screening; AST, ALT, and total bilirubin ≥ 1.5 times upper limit of normal or CK (Creatine Kinase) \> 2.5 times upper limit of normal
4. Subjects who had history of drug abuse or showed a positive result on a drug screening urine test.
5. Subjects who showed a positive result for a serology test (HBsAg, Anti-HCV , HIV Ab, or VDRL), etc.

Primary outcomes:
measure: Assess the AME of LCB01-0371
timeFrame: an average of 8 days (+ - 1 D)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Howard Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06264596: Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery
Official title: The Effect of Epinephrine in Irrigation Fluid for Visualization During Ankle Arthroscopy: A Randomized Blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Intraoperative Bleeding
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 0
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 purpose of this study is to evaluate the effect of epinephrine in irrigation fluid for visual clarity in ankle arthroscopic surgery.

Detailed description: The primary outcomes are:

* visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale from 0-10,
* and the intraoperative surgeon's discomfort related to bleeding, that will be measured by visual numeric rating scale from 0-3.

Eligibility criteria: Inclusion Criteria:

* Males and Females ages over 18 years
* Patients who undergo ankle arthroscopic surgery
* Patients who are able to read and give informed consent on their own behalf

Exclusion Criteria:

* Patients with any known cardiac diseases
* Uncontrolled hypertension (\> 180/110 mmHg)
* Revision case
* Younger than 18 years of age
* Pregnant women

Primary outcomes:
measure: visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale
timeFrame: intraoperative
measure: surgeon's discomfort related to bleeding, measured by visual numeric rating scale
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
Study officials:
affiliation: The Guthrie Clinic
name: Wonyong Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02720796: Patient-Derived Xenograft (PDX) Modeling in Adult Patients With Metastatic or Recurrent Sarcoma
Official title: A Prospective Correlative Trial of Personalized Patient-Derived Xenograft (PDX or TumorGraft) Modeling in Adult Patients With Metastatic or Recurrent Sarcoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sarcoma
Keywords: PDX
TumorGraft
Patient derived xenograft
sarcoma
Lead sponsor: Champions Oncology
Sponsor class: INDUSTRY
Collaborators: name: Mount Sinai Hospital, Canada
First posted: 2016-03-28
Enrollment: 17
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients with recurrent or metastatic sarcoma will be consented to develop a patient derived xenograft (PDX or TumorGraft) model of their tumor to perform drug sensitivity testing. The purpose of the study is to evaluate the accuracy of the patient derived xenograft (PDX) model in predicting patient clinical response to the same drug treatment.


Eligibility criteria: * 15 years of age or older
* Patients with metastatic sarcoma who have had no more than one prior systemic treatment for metastatic disease
* Patients with recurrent sarcoma at relapse
* Patients with confirmed histological diagnosis of sarcoma or suspected diagnosis of sarcoma. Some specific subtypes of sarcoma are NOT eligible (Gastrointestinal Stromal Tumor (GIST), carcinosarcoma, sarcomatoid mesothelioma, and metastatic phyllodes tumor)
* If initial suspected diagnosis of sarcoma, must have sarcoma diagnosis confirmed prior to proceeding with PDX drug sensitivity testing
* Must have measureable disease for computed tomography (CT) scan or magnetic resonance imaging (MRI) evaluation following biopsy or surgery to obtain tissue for PDX development.
* No plan for concurrent chemoradiation, for target lesions that will be used for drug treatment correlation with PDX
* Fresh tumor tissue available for PDX development
* Eastern Cooperative Oncology Group performance status of 0-1
* Life expectancy exceeds 6 months
* Plan to receive systemic therapy
* Informed consent

Primary outcomes:
measure: Number of patients' whose personalized PDX model accurately predicts clinical response to therapy with same drug treatment.
timeFrame: 3 years
Secondary outcomes:
measure: Number of patients' whose personalized PDX model accurately predicts clinical response to therapy over subsequent lines of therapy.
timeFrame: 3 years
measure: Factors that impact on engraftment success.
timeFrame: 2 years
measure: Factors that impact time to drug sensitivity testing.
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Mount Sinai Hospital, Toronto, Ontario, Canada
name: Albiruni Razak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00410696: Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy
Official title: Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy With Peripheral Autologous Stem Cell Reinfusion in Patients With Hematological Neoplasms and Solid Tumors: Phase II Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hematological Neoplasms
Tumors
Keywords: High-dose chemotherapy
Growth factor
Pegfilgrastim
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2006-12-13
Enrollment: 80
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 primary objective of the study is to evaluate the efficacy and the safety of pegfilgrastim versus filgrastim, administered after high-dose chemotherapy and peripheral stem cell reinfusion.

Detailed description: Secondary objective is to evaluate the immunological reconstitution after pegfilgrastim and filgrastim.

Eligibility criteria: Inclusion Criteria:

* Patients with hematological neoplasms or solid tumors candidable to high-dose chemotherapy with autologous peripheral stem cell reinfusion
* Adequate organ function
* Written informed consent.

Exclusion Criteria:

* Use of other experimental drugs
* Active infection

Primary outcomes:
measure: Duration of aplasia period
timeFrame: At time of discharge from Unit
Secondary outcomes:
measure: Immunological reconstitution
timeFrame: 1 year after transplantation
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: STUDY_DIRECTOR
References:
citation: Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002 Feb 1;20(3):727-31. doi: 10.1200/JCO.2002.20.3.727.
citation: Farese AM, Yang BB, Roskos L, Stead RB, MacVittie TJ. Pegfilgrastim, a sustained-duration form of filgrastim, significantly improves neutrophil recovery after autologous marrow transplantation in rhesus macaques. Bone Marrow Transplant. 2003 Aug;32(4):399-404. doi: 10.1038/sj.bmt.1704156.
citation: Castagna L, Bramanti S, Levis A, Michieli MG, Anastasia A, Mazza R, Giordano L, Sarina B, Todisco E, Gregorini AI, Santoro A. Pegfilgrastim versus filgrastim after high-dose chemotherapy and autologous peripheral blood stem cell support. Ann Oncol. 2010 Jul;21(7):1482-1485. doi: 10.1093/annonc/mdp576. Epub 2009 Dec 11.
Clinical trial NCT05700396: Breast Cancer Survivor Educational Intervention
Official title: Increasing Receipt of Guideline Concordant Survivorship Care Among Black Breast Cancer Survivors Through Patient Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Neoplasms
Breast Carcinoma
Breast Cancer Female
Keywords: Breast Cancer
Breast Neoplasms
Breast Carcinoma
Breast Cancer Female
Breast cancer survivor
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Pfizer
First posted: 2023-01-26
Enrollment: 7
Sex: FEMALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to test a 6-week virtual education program among Black breast cancer survivors. The virtual program includes sessions on physical activity, goal setting, nutrition, sleep, stress, and social connections.

Detailed description: This six-week feasibility study will evaluate a virtual support and education program among up to 15 Black female breast cancer survivors. Participants will be asked to attend a 90 minute group session once a week for 6 weeks and complete surveys pre and post intervention surveys to ascertain study endpoints. This study is supported by funding from Pfizer and in-kind support from the American Cancer Society, Inc.

Eligibility criteria: Inclusion Criteria:

* Female
* Self-identified Black or African American race
* Age 22-79
* Diagnosis of Stage I, II, or III invasive breast cancer
* Completed active treatment at least 6 months ago, but within the past five years
* Speaks English

Exclusion Criteria:

* Undergoing active treatment (i.e., surgery, chemotherapy, radiation)
* Undergoing evaluation for suspected recurrence

Primary outcomes:
measure: Recruitment Retention Rate
timeFrame: 6 weeks
measure: Time Required to Recruit to Target
timeFrame: 6 weeks
measure: Proportion of Eligible Participants
timeFrame: 6 weeks
measure: Rate of Intervention Completion
timeFrame: 6 weeks
measure: Success Rate of Educational Intervention
timeFrame: 6 weeks
measure: Data collection feasibility
timeFrame: 6 weeks
Secondary outcomes:
measure: Self-Efficacy for symptom self-management
timeFrame: 6 weeks
measure: Intention to Receive post-treatment Surveillance Mammography
timeFrame: 6 weeks
measure: Physical Activity Goal Change
timeFrame: 6 weeks
measure: Dietary Behavior Goal Change
timeFrame: 6 weeks
measure: Unmet information Needs
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Erica Warner, MPH, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Amy Comander, MD
role: STUDY_DIRECTOR
affiliation: Boston Medical Center
name: Naomi Ko, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02965196: Dexamethasone Therapy for Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-11-16
Enrollment: 60
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: The study will evaluate the efficacy of IV Dexamethasone in treatment low back pain as an adjunct to analgesics.


Eligibility criteria: Inclusion Criteria:

* No "red flags" of serious spinal pathology
* Normal neurological examination
* Indication for opioid analgesia based on our pain management protocol
* No known hypersensitivity to the medication
* Ability to provide informed consent

Exclusion Criteria:

* Pregnancy
* All others who do not meet inclusion criteria

Primary outcomes:
measure: Pain Reduction
timeFrame: Four days
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT06745596: Anterior Segment Changes After Phacoemulsification in Cataractous Eyes with Shallow Anterior Chamber
Official title: Anterior Segment Changes After Phacoemulsification in Cataractous Eyes with Shallow Anterior Chamber with and Without Limited Anterior Pars Plana Vitrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Limited anterior pars plana vitrectomy
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-12-20
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 24 eyes were operated on and divided into two groups. Twelve eyes underwent combined approach and the other 12 eyes have undergone phacoemulsification only
Primary purpose: TREATMENT

Brief summary: Phacoemulsification in shallow anterior chamber is considered to be more hazardous regarding risk of intraoperative and postoperative complications. Limited anterior pars plana vitrectomy can be combined with phacoemulsification to deepen the anterior chamber and facilitate surgical steps

Detailed description: Phacoemulsification in shallow anterior chamber is considered to be more hazardous regarding risk of intraoperative and postoperative complications. Limited anterior pars plana vitrectomy can be combined with phacoemulsification to deepen the anterior chamber and facilitate surgical steps. This study aimed to compare the efficacy of combined phacoemulsification with limited pars plana vitrectomy versus phacoemulsification alone in cases with shallow anterior chamber.

Methods: 24 eyes were operated on and divided into two groups. Twelve eyes underwent combined approach and the other 12 eyes have undergone phacoemulsification only.

Eligibility criteria: Inclusion criteria:

* Anterior chamber depth of less than 2.8 mm associated with cataract

Exclusion Criteria:

* Mature cataract
* History of previous ocular surgery
* Posterior segment pathology

Primary outcomes:
measure: Central corneal thickness in micrometers.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
state: Sharkia
Study officials:
affiliation: Zagazig University
name: Mahmoud Mohammad Gamal Mohammad Gamal, MBBCh
role: STUDY_DIRECTOR
References:
Clinical trial NCT01522196: A Study of Varespladib Infusion in Subjects With Sickle Cell Disease.
Official title: A Randomized, Double-blind, Placebo-Controlled Study With Varespladib Infusion (A-001) in Subjects With Sickle Cell Disease and Vaso-Occlusive Crisis for the Prevention of Acute Chest Syndrome At-Risk Subjects.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sickle Cell Disease
Vaso-occlusive Crisis
Keywords: SCD
Lead sponsor: Anthera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-01-31
Enrollment: 2
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effectiveness of A 001 infusion in preventing acute chest syndrome in sickle cell disease (SCD) subjects with vaso-occlusive crisis, fever, and elevated serum C-reactive protein (CRP).


Eligibility criteria: Inclusion Criteria:

* Genotypes Hb SS, Hb SC, sickle β°-thalassemia, sickle β+ -thalassemia
* Pain consistent with vaso-occlusive crisis (clinical judgment) and not attributable to other causes
* Serum CRP ≥5.0 mg/L at time of screening
* Fever defined as oral temperature ≥38.0°C at time of screening
* Age ≥5 years

Exclusion Criteria:

* New or suspected new pulmonary infiltrate diagnosed by chest radiography
* Females who are nursing, pregnant or intend to become pregnant
* Renal dysfunction defined as a creatinine level \>1.2 mg/dL for subjects aged 18 or less or a creatinine level \>1.5 mg/dL for subjects over the age of 18
* Hepatic dysfunction (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \>3 × upper limit of normal)
* Acute neurologic dysfunction
* Any medical condition for which transfusion may be needed imminently, and/or hemoglobin \<5 g/dL
* Red blood cell transfusion within 30 days prior to screening
* Parenteral or oral corticosteroid therapy (inhaled steroids acceptable) within 7 days prior to screening

Primary outcomes:
measure: Efficacy of A 001 infusion in preventing acute chest syndrome in sickle cell disease (SCD) subjects with the combination of vaso-occlusive crisis, fever, and elevated serum C-reactive protein (CRP).
timeFrame: Various time points up to Day 30
Secondary outcomes:
measure: Safety and tolerability of A 001 therapy when administered as a 48-hour continuous infusion to SCD subjects at-risk for acute chest syndrome.
timeFrame: Various time points up to Day 30
measure: Impact of A-001 treatment on sPLA2 levels and CRP.
timeFrame: Various time points up to Day 30
measure: Impact of A-001 treatment on the signs and symptoms of vaso-occlusive crisis.
timeFrame: Various time points up to Day 30
measure: Impact of A-001 treatment on opioid use for pain in the treatment of vaso-occlusive crisis.
timeFrame: Various time points up to Day 30
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Investigator Site 101
state: Georgia
Study officials:
References:
Clinical trial NCT06967896: Different Models of Tracheal Catheters Are Used for Female Thyroid Glands
Official title: A Randomized Controlled Trial Comparing Different Models of Tracheal Tube for Thyroid Surgery in Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sore Throat
Tracheal Tubes With an Inner Diameter of 6.0mm
Tracheal Tubes With an Inner Diameter of 6.5mm
Tracheal Tubes With an Inner Diameter of 7.0mm
Keywords: thyroid surgery
sore throat
Tracheal tube
Lead sponsor: Anqing Municipal Hospital
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy female thyroid surgery patients, ages 18-65 years, did not have serious systemic disease

Brief summary: Objective:Compare whether the use of tracheal catheters of models 6.0 and 6.5 causes less sore throat in women after thyroid surgery compared with the traditional use of model 7.0 tracheal catheters.Methods: Investigators enrolled 180 female patients with American Society of Anesthesiologists (ASA) physical status I and III, aged 18-65 years, and scheduled for elective undergoing thyroid surgery with general anesthesia. The participants were randomly assigned into three groups(n=60 each group):Group A: Tracheal catheter group with an inner diameter of 6.0mm, Group B: Tracheal catheter group with an inner diameter of 6.5mm, Group C: Tracheal catheter group with an inner diameter of 7.0mm.The incidence and severity of postoperative sore throat were recorded in three groups at 1 h, 6 h, 24 h and 48 h after operation.


Eligibility criteria: Inclusion Criteria:

* Female;
* Thyroid surgery should be performed under general anesthesia (GA) at an appropriate time;
* ASA grade I-III;
* Aged 18-65 years;
* BMI less than 35Kg/m2
* In line with ethics, patients voluntarily accept this experiment and sign informed consent.

Exclusion Criteria:

* Reflux esophagitis, preoperative sore throat, chronic pharyngitis, preoperative hoarseness, use of anticoagulants or corticosteroids, high risk of reflux or aspiration, dysphagia, previous oral or pharyngeal surgical intervention, bleeding disorder, severe heart, lung, liver and kidney dysfunction
* Upper respiratory tract infection occurred within 2 weeks before surgery
* Unable to insert ET (no more than two intubations)
* Patients with hoarseness or sore throat before surgery
* Language communication, hearing impairment or brain dysfunction such as stroke, unable to communicate

Primary outcomes:
measure: The incidence of postoperative sore throat
timeFrame: at 1 hour, 6 hour, 24 hour and 48 hour after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Anqing
country: China
facility: Department of Anqing Hospital Anesthesiology
state: Anhui
Study officials:
References: