louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02319486: CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma
Official title: CEV With/Without Periocular Carboplatin Chemotherapy for Nonmetastatic Extraocular Retinoblastoma Carboplatin--A Single Center, Retrospective Study to Evaluate the Efficacy of Carboplatin in Subjects With Retinoblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retinoblastoma
Keywords: Retinoblastoma
carboplatin
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-12-18
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular retinoblastoma

Detailed description: This study will be a phase 4 open label interventional case series. Patients with retinoblastoma will be receive chemotherapy with or without periocular injections of carboplatin at a dose of 20mg/2 ml. Patients will receive chemotherapy on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 18 months .

Eligibility criteria: Inclusion Criteria:

* IRSS stage II or stage IIIa RB patients.
* for patients with IRSS stage II disease, if scleral surface invasion alone was observed, only systemic chemotherapy was administered, whereas other IRSS stage II and IIIa patients received systemic chemotherapy plus additional local chemotherapy.
* no tumor-related treatment was given prior to this chemotherapy regimen.

Exclusion Criteria:

* metastasis, including lymph node metastasis.
* the diagnosis of IRSS stage I or above in the non-target eye.

Primary outcomes:
measure: Event Free Survival Rate
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Huasheng Yang, M.D, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT02281786: A Study of RO6926496 in Healthy Volunteers
Official title: A SINGLE-CENTER, RANDOMIZED, INVESTIGATOR/SUBJECT BLIND, SINGLE ASCENDING DOSE, PLACEBO CONTROLLED, PARALLEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF RO6926496 FOLLOWING INTRAVENOUS INFUSION IN HEALTHY SUBJECTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-11-04
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a single center, randomized, investigator/subject blind, single ascending dose, placebo-controlled, parallel study that will evaluate the safety, tolerability and pharmacokinetics of RO6926496 in healthy male participants. The dose escalation is adaptive in nature. It is planned to enroll 48 subjects in 6 cohorts. The anticipated total duration of the study is 16 weeks.


Eligibility criteria: Inclusion Criteria:

* Healthy male participants, 18 to 45 years of age; healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history
* A body mass index between 18 and 30 kg/m2
* Male subjects and their partners of childbearing potential must agree to use 2 methods of contraception, one of which must be a barrier method for the duration of the study

Exclusion Criteria:

* Positive hepatitis B, hepatitis C, or HIV infection
* History of any clinically significant disease or disorder
* Clinically significant abnormalities in laboratory test results
* Participation in an investigational drug or device study within 90 days prior to screening
* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
* History or presence of clinically significant ECG abnormalities
* Smokers who smoke more than 10 cigarettes daily or equivalent and unable or unwilling not to smoke during the in-clinic period
* Any clinically relevant history of hypersensitivity or allergic reactions
* Any familial history of early onset Alzheimer's disease

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Pharmacokinetic profile and parameters derived from serum concentrations of RO6926496 (composite outcome measure): area under the concentration-time curve (AUC), Cmax, tmax, clearance
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00348686: Candesartan Effectiveness Study in Pro-B Type Natriuretic Peptides (BNP)
Official title: A Multicenter, Non-comparative, Phase IV Study to Evaluate the Effect of Candesartan Based Therapy in the Percent Change of proBNP Level After 24 Week Treatment in the Patients With Hypertension With Left Ventricular Hypertrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Left Ventricular Hypertrophy
Keywords: LVH
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-07-06
Enrollment: 315
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: The purpose of this study is to investigate effect of candesartan based therapy on percent change of B type natriuretic peptides(BNP) level in the subjects with hypertension and left ventricular hypertrophy.


Eligibility criteria: Inclusion Criteria:

* Hypertension with diastolic blood pressure within 95-115 mm/Hg or/and systolic blood pressure within 160-200 mm/Hg
* Patients diagnosed as left ventricular hypertrophy by electrocardiogram

Exclusion Criteria:

* Secondary hypertension
* History of myocardial infarction
* Stroke within the previous 6 months

Primary outcomes:
measure: Percent Change of B Type Natriuretic Peptides (BNP) Level
timeFrame: At Baseline and 24 weeks
Secondary outcomes:
measure: LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index
timeFrame: At Baseline and 24 weeks
measure: Change of Systolic Blood Pressure (SBP)
timeFrame: At Baseline and 24 weeks
measure: Change of Diastolic Blood Pressure (DBP)
timeFrame: At Baseline and 24 weeks
measure: Percent Change of proBNP(B Type Natriuretic Peptides) in Patients Treated With Candesartan Only
timeFrame: At Baseline and 24 weeks
measure: Percent Change of proBNP(B Type Natriuretic Peptides) in Patients With Candesartan Plus Felodipine
timeFrame: At Baseline and 24 weeks
Other outcomes:
Locations:
city: BuSan
country: Korea, Republic of
facility: Research Site
city: CheonAn
country: Korea, Republic of
facility: Research Site
city: CheongJu
country: Korea, Republic of
facility: Research Site
city: Chunbuk
country: Korea, Republic of
facility: Research Site
city: DaeGu
country: Korea, Republic of
facility: Research Site
city: DaeJeon
country: Korea, Republic of
facility: Research Site
city: Gyungsangnamdo
country: Korea, Republic of
facility: Research Site
city: JeonJu
country: Korea, Republic of
facility: Research Site
city: KwangJu
country: Korea, Republic of
facility: Research Site
city: Pusan
country: Korea, Republic of
facility: Research Site
city: Ulsan
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: JeeWoong Son, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06309186: Empowerment and Burnout of Midwives at the End of Health Emergency From COVID-19
Official title: Empowerment and Burnout of Midwives at the End of Health Emergency From SARS-CoV2: a Cross-sectional Observational Study in Friuli-Venezia Giulia Region
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: Midwifery
Empowerment
Burnout
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Midwives

Brief summary: As the fifth wave of COVID-19 comes to an end and the pandemic's countermeasures expire, there is a need to assess the impact of the pandemic on health care providers, especially midwives, as the professionals deputed to promote and protect women's holistic health, in all phases, physiological and otherwise, of the life cycle. The midwife considers the person as a whole, in which the mind-body-culture components interact profoundly. Prevention and containment measures have impacted on midwifery clinical and nursing practices with the mandatory continuous use of personal protective equipments (PPE) and social distancing to protect the patient and the practitioner, effectively hindering the intimacy of the woman-midwife relationship. The impact assessment focuses on two dimensions: learning, investigated as perceived empowerment, and perceived malaise, investigated as burnout. Empowerment has a positive connotation, which can offset burnout, a syndrome that affects the physical, psychological and emotional health of midwives and can have significant negative implications on midwife turnover, patient safety and outcomes, and the efficiency of healthcare organisations.


Eligibility criteria: Inclusion Criteria:

1. Midwives registered in the orders of Friuli Venezia Giulia (FVG) region
2. Midwives in practice for at least one year
3. Midwives practicing in FVG region

Exclusion Criteria:

1. Consent not granted
2. Midwives in retirement for more than a year

Primary outcomes:
measure: Evaluation of empowerment of midwives
timeFrame: At enrolment
measure: Number of midwives affected by burnout
timeFrame: At enrolment
Secondary outcomes:
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
city: Trieste
country: Italy
facility: Ordine delle ostrtriche di Trieste e Gorizia
Study officials:
References:
Clinical trial NCT00083486: Treatment of Anemia in Patients With Cancer Who Are Not Currently Receiving Chemotherapy or Radiotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2004-05-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of different doses of epoetin alfa for treating anemia in patients who have cancer; or patients who no longer have any signs of cancer, but remain anemic as a result of their treatment. These patients should not be currently receiving chemotherapy or radiotherapy. A subject's participation in the study will last approximately 6 months. Subjects will receive weekly doses of epoetin alfa or placebo. Their hemoglobin will be tested every week.


Eligibility criteria: Inclusion Criteria:

* Body weight \>/=99 lbs
* ECOG 0-2
* Anemia results from cancer, chemotherapy, radiotherapy or an association with hormonal therapy or immunotherapy
* Screening hemoglobin level of \</=11.0 g/dL for men or \</=10.0 for women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Heritage Physician Group-Oncology
state: Arkansas
city: Griffin
country: United States
facility: Spalding Oncology Services
state: Georgia
city: Centralia
country: United States
facility: Southern Illinois Hematology
state: Illinois
city: Rockville
country: United States
facility: BioLab Research
state: Maryland
city: New Hartford
country: United States
facility: Slocum-Dickson Medical Group, PC
state: New York
city: Concord
country: United States
facility: NorthEast Urology Research
state: North Carolina
city: Columbus
country: United States
facility: Mid Ohio Oncology Hematology
state: Ohio
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Aiken
country: United States
facility: Caroline Cancer Center
state: South Carolina
city: Charleston
country: United States
facility: Charleston Hematology Oncology
state: South Carolina
city: Charleston
country: United States
facility: Charleston Cancer Care
state: South Carolina
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
Study officials:
References:
Clinical trial NCT04272086: Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy
Official title: Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: a Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Fibroid Uterus
Keywords: Fibroid uterus
Myomectomy
Abdominal myomectomy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized control trial with intervention arm as liposomal bupivacaine tap and intervention as standard bupivacaine tap
Primary purpose: TREATMENT

Brief summary: The study team will be randomizing patients presenting for open myomectomy to either received transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine. The study team will be analyzing the impact of local anesthetic on opiate consumption as the investigator's primary endpoint with other secondary endpoints.

Detailed description: After consent, patients will be randomized to either liposomal bupivacaine Transversus Abdominal Plane (TAP) vs standard bupivacaine TAP. Blocks will occur post induction and pre incision. Only the block team (not the anesthesia team nor the care team) will be unblinded and they will not have any impact on the data collection. The entire care team and the patient will be blinded. A standardized anesthetic regimen will be employed followed by a prescriptive post-operative pain management plan aimed at enhanced recovery. Patients will be followed for up to 96 hours and asked about their opiate consumption, pain scores, side effects, and recovery.

Eligibility criteria: Inclusion Criteria:

* Not pregnant
* Weight over 50kg presenting for open myomectomy
* No history of allergy to any study medication
* No history of malignant ventricular dysrhythmia, epilepsy, seizure disorder, or chronic pain syndrome other than pain from myomas
* No history of drug or alcohol use or abuse disorder or pre-existing liver disease.

Primary outcomes:
measure: Morphine Equivalents at 72 Hours
timeFrame: 72 hours
Secondary outcomes:
measure: Morphine Equivalents at 96 Hours
timeFrame: 96 hours
measure: Morphine Equivalents at 48 Hours
timeFrame: 48 hours
measure: Opiate Sparing Criteria at 72 hours
timeFrame: 72 hours
measure: Quality of Recovery at 48 hours
timeFrame: 48 hours
measure: Quality of Recovery at 72 hours
timeFrame: 72 hours
measure: Area under the curve pain scale at 96 hours
timeFrame: 96 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Daniel Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04331886: An Observational Study of Patients With Coronavirus Disease 2019
Official title: An Observational Study of Patients With Coronavirus Disease 2019
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Coronavirus
Lead sponsor: Target PharmaSolutions, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-02
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data for up to 5,000 hospitalized patients with a positive diagnosis of coronavirus disease 2019 (COVID-19) in the United States will be collected in TARGET-COVID-19.

Brief summary: This is an observational study of patients with COVID-19 designed to specifically address important clinical questions that remain incompletely answered for coronavirus disease 2019.

Detailed description: Data from up to 5,000 adult patients in the US will be captured from eligible patients enrolled following admission to the hospital. Participants will have de-identified medical records collected from hospital admission to discharge, including but not limited to critical care monitoring, details on mechanical ventilation, laboratory data, imaging reports, medications, and all procedures. Diagnosis and patient management will follow each hospital's standard of care and no specific treatments, procedures or laboratory tests will be dictated by enrollment in TARGET-COVID-19.

Eligibility criteria: Inclusion Criteria:

* Adults (age ≥18 years) who are or have been hospitalized and diagnosed with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection.
* SARS-CoV-2 confirmed diagnosis (e.g. polymerase chain reaction \[PCR\] or other clinically utilized test).

Exclusion Criteria:

N/A

Primary outcomes:
measure: Natural history of COVID-19: Characteristics of COVID-19
timeFrame: 12 months
measure: Natural history of COVID-19: Participant demographics
timeFrame: 12 months
measure: Natural history of COVID-19: Treatment use
timeFrame: 12 months
measure: Time point of clinical response
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
Clinical trial NCT00734786: Efficacy and Safety of a Cutaneous Formulation of Gonyautoxin 2/3 (GTX 2/3) for the Treatment of Facial Wrinkles
Official title: Efficacy and Safety of a Cutaneous Formulation of Gonyautoxin 2/3 (GTX 2/3) for the Treatment of Facial Wrinkles. Study # CLN 08-003.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Facial Wrinkles
Keywords: gonyautoxin
Lead sponsor: Phytotox SA
Sponsor class: INDUSTRY
First posted: 2008-08-14
Enrollment: 15
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of the trial is to determine whether the current topical formulation of GTX 2/3 reduces the wrinkling of the skin (crow's feet) after a single application

Other evaluation criteria include: safety assessment and local tolerance, depth of facial wrinkles (video microscopy imaging).

Detailed description: This is a single volunteer group study. Each volunteer will be her own control. A volunteer will receive the active product containing cream on one side of her face and will receive the placebo cream on the other side.

Eligibility criteria: Inclusion Criteria:

* Women with no bearing-child potential or with adequate birth control method.
* Volunteers between 30 to 60 years of age.
* Subjects with bilateral crow's feet wrinkles.
* Regular user of cosmetic products, willing and able to comply with the study objectives.
* Signed informed consent.

Exclusion Criteria:

* Any medical condition or any use of a medication that could modify the study results (e.g.: NSAIDs, immunosuppressant drugs, insulin...).
* Any other significant medical condition (e.g.: diabetes mellitus, heart disease, liver disease...).
* Any other condition that in the investigator's opinion could not be appropriate with the participation in this trial.
* Any health condition that could affect the evaluation of study parameters.
* Acute or chronic skin disease.
* History of allergic reaction to cosmetic compounds.
* Pregnancy, planned pregnancy or breast-feeding.
* Allergy to shellfish, fish or sea product (seaweed).
* Known or suspected hypersensitivity to any of the study product compounds.
* Participation in another clinical trial within 30 days previous to enrolment.
* Known or suspected alcohol or drug abuse.

Primary outcomes:
measure: Depth of facial wrinkles
timeFrame: 24 hours
Secondary outcomes:
measure: Local and general tolerance
timeFrame: 1day
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: CLAIM
state: CF
Study officials:
affiliation: CLAIM
name: Silvia H Pérez-Damonte, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02101086: Autologous Cord Blood Transfusion in Preterm Infants
Official title: Evaluation of the Efficacy and Safety of Autologous Cord Blood Transfusions in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia of Prematurity
Keywords: umbilical cord blood
premature
autologous transfusion
allogeneic transfusion
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2014-04-01
Enrollment: 39
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of autologous cord blood transfusions in very-low-birth-weight premature infants, and to evaluate the developmental outcomes of the infants who received autologous transfusions.

Detailed description: Blood transfusions have many risks including transfusion reactions and infections. Cord blood is accepted as an alternative method for red cell transfusions in low-birth weight (LBW) premature newborns. However, experience and scientific evidence concerning in-vivo efficacy and safety of red blood cell (RBC) concentrates derived from cord blood in very LBW premature newborns is still insufficient.

A total of 50 umbilical cord blood (UCB) collected from infants born before 32 weeks' gestational age and processed into autologous RBC products. Infants requiring blood transfusion were randomly assigned to an autologous or allogeneic product. Two randomized groups were compared on the 14th, 28th, 35th days and \>35th days with respect to hemoglobin levels, transfusion numbers, transfusion and phlebotomy volumes, and hemoglobin, reticulocyte counts and erythropoietin levels in the postconceptional 36th and 40th weeks' gestation, and hemoglobin levels at postnatal 6-months age. All transfused infants were developmentally assessed by the end of the postnatal first year.

Eligibility criteria: Inclusion Criteria:

* Preterm infants born at ≤ 32 weeks gestational age
* Parental consent

Exclusion Criteria:

* rhesus incompatibility
* hydrops fetalis
* maternal viral or bacterial infections including suspected chorioamnionitis
* parental refuse

Primary outcomes:
measure: Number and percentage of participants that receive autologous transfusion with a decrease in allogeneic transfusion
timeFrame: one year
Secondary outcomes:
measure: The hemoglobin levels at postnatal 14th days
timeFrame: 14 days
measure: The hemoglobin levels at postnatal 28th days
timeFrame: 28 days
measure: The hemoglobin levels at postnatal 35th days
timeFrame: 35 days
measure: The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 36 weeks
timeFrame: 3 months
measure: The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 40 weeks
timeFrame: 5 months
measure: Developmental assessments of infants
timeFrame: One year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University School of Medicine
Study officials:
affiliation: Ankara University
name: Saadet Arsan, Professor
role: STUDY_DIRECTOR
References: