louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01176552: Granulocyte-macrophage Colony-stimulating Factor, Interferon and Interleukin-2 as Adjuvant Treatment for Renal Cancer
Official title: Granulocyte-macrophage Colony-stimulating Factor, Interferon Alpha and Interleukin-2 as Adjuvant Treatment for High-risk Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Keywords: Kidney Cancer
Renal cell carcinoma
High risk
Adjuvant therapy
Lead sponsor: Kidney Cancer Research Bureau
Sponsor class: OTHER
First posted: 2010-08-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective study assesses toxicity and potential efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon (IFN) alpha and interleukin-2 (IL-2) postoperatively in patients with high-risk renal cell carcinoma (RCC).

Detailed description: Patients with high-risk RCC have a dismal prognosis. To date, no effective adjuvant therapy exists for this patients category. We suggest that combination of granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon alpha (IFN) and interleukin-2 (IL-2) stimulate immune system from dendritic cells till cytotoxic T-lymphocytes step by step and eliminate residuary tumor cells.

This prospective, non-randomized, phase II trial assessed low-dose GM-CSF, IFN and IL-2 postoperatively in patients with high-risk renal cell carcinoma.

Eligibility criteria: Inclusion Criteria:

* completely resected advanced high-risk RCC
* T3b-c, T4, or N1-2, or M1 disease resected to no evidence of disease (AJCC-TNM, 2002) Patients must have recovered from any effects of surgery, which must have been - excellent performance status (Eastern Cooperative Oncology Group performance status of 0 or 1);
* adequate organ function defined as WBC count 4,000/µL, platelet count 100,000/µL, hemoglobin 10 g/dL, serum creatinine 1.5 mg/dL or creatinine clearance 60 mL/min, and direct bilirubin 1.5 mg/dL; and forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing
* age 18 years and older

Exclusion Criteria:

* history or evidence of cardiac disease on ECG or autoimmunity
* prior systemic treatment for RCC
* history of invasive malignancy in the past 5 years or human immunodeficiency virus positivity
* positive pregnancy test

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 3.5 years
Secondary outcomes:
measure: Progression rate
timeFrame: 28 months
measure: Overall survival (OS)
timeFrame: 5 years
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 12 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: N.N. Blokhin Russian Cancer Research Center
Study officials:
affiliation: N.N. Blokhin Russian Cancer Research Center
name: Lev Demidov, M.D., D.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04938752: Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects (DA-2811)
Official title: An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA 2811 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and DA-2811-R after a single oral dose in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects
* BMI between 18.5 and 29.9 kg/m2 and weigh at least 50 kg
* Volunteer who totally understands the progress of this clinical trial, make decision by his or her free will, and signed a consent form to follow the progress

Exclusion Criteria:

* Volunteer who has present or past history of clinically significant cardiovascular, respiratory, urinary, gastrointestinal, hepatic, renal, skin, immunological, musculoskeletal, endocrinal, neurological, psychiatric and/or hematological disease

Primary outcomes:
measure: AUClast
timeFrame: pre-dose~48 hours post-dose
measure: Cmax
timeFrame: pre-dose~48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Seongnam-si
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chung JaeYong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06760052: Longitudinal Data Registry of Plasma Cell Dyscrasia
Official title: Longitudinal Data Registry of a Spectrum of Plasma Cell Dyscrasia with Long-term Follow-up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma and Other Plasma Cell Neoplasms
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathological diagnosis of PCD from 2007 to 2027 according to 2016 WHO classification.

Brief summary: This study aims to identify clinical characteristics, response and clinical outcome of plasma cell dyscrasia (PCD) diagnosed in Zhongshan Hospital, Fudan University from May 2023. In its current version, the registry incorporates historical data (collected from 2007) and is prospectively collecting follow-up data and recording patient outcomes.

Detailed description: PCD is a spectrum of diseases that is being gradually understood in Asia. This study aims to observe and describe the clinical and genetic characteristics of Chinese PCD patients, and to explore the relationship between the characteristics and pathogenesis. It also aims to discover the potential distinct clonal evolution patterns among different subtype of this disease spectrum. This study is a non-interventional real-world, study. Alll registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

Eligibility criteria: Inclusion Criteria:

Patients with pathological diagnosis of PCD \[e.g.: symptomatic/asymptomatic multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), POEMS syndrome, light chain (AL) amyloidosis) from 2007 to 2027 in Zhonshan Hospital.

Patients who had complete diagnostic, treatment and follow-up records. With fully comprehension and signature of the informed consent form (ICF) for participation.

Exclusion Criteria:

Patients who refused to use reliable methods of contraception during pregnancy, lactation or age-appropriate period.

Patients who suffered from severe mental illness. Patients who were deemed unsuitable for inclusion by the investigator.

Primary outcomes:
measure: Overall survival
timeFrame: From the time of enrollment to data cut-off (Up to approximately 20 years).
Secondary outcomes:
measure: Progression-free survival
timeFrame: From the time of enrollment to data cut-off (Up to approximately 20 years).
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT05150652: Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
Official title: Phase 2 Study of Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
HER2-negative Breast Cancer
Node-negative Breast Cancer
Breast Carcinoma
Keywords: Neoadjuvant endocrine therapy
Early stage
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to access whether treatment of early state estrogen-rich breast cancers with neoadjuvant endocrine therapy will result in higher rates of margin negativity on lumpectomy specimen.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed invasive breast cancer, clinically stage I-II.
* Clinically lymph node negative
* Eligible for anti-endocrine treatment (per medical oncologist)
* Postmenopausal women
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Progesterone receptor negativity
* High grade tumor
* Synchronous non-breast malignancy
* Receiving any other investigational agents that could impact the efficacy of this trial regimen
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Anastrozole, Letrozole, Exemestane, Tamoxifen or other agents used in study
* Uncontrolled intercurrent illness
* Medical, psychiatric or other condition and/or social situations that would limit compliance with study requirements

Primary outcomes:
measure: Change in margin status
timeFrame: Baseline, 6-months after neoadjuvant treatment and surgery
Secondary outcomes:
measure: Residual cancer burden
timeFrame: After neoadjuvant treatment and surgery (approximately 6 months from diagnosis)
measure: Pattern of response
timeFrame: After neoadjuvant treatment and surgery (approximately 6 months from diagnosis)
measure: Change in satisfaction with cosmetic outcome
timeFrame: After neoadjuvant treatment and surgery (approximately 6 months and 12 months post-surgery)
Other outcomes:
measure: Change in largest caliper measurement
timeFrame: Baseline, 6-months after neoadjuvant treatment and surgery
Locations:
city: Lexington
country: United States
facility: University of Kentucky Markey Cancer Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Irada Ibrahim-zada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01807052: Biomarker Expression in Tissue Samples From Patients With Bone Sarcomas
Official title: Observational - Tissue Factor Expression in Bone Sarcomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Localized Osteosarcoma
Metastatic Osteosarcoma
Recurrent Osteosarcoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-03-08
Enrollment: 34
Sex: ALL
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tissue samples from patients with osteosarcomas obtained from the CHTN that participated in either study P9754 clinical trial for patients with non-metastatic osteosarcoma or AOST0121 clinical trial for patients with metastatic or recurrent osteosarcoma

Brief summary: This trial studies biomarker expression in tissue samples from patients with bone sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer

Detailed description: STUDY SUBTYPE: Ancillary/Correlative

OBSERVATIONAL STUDY MODEL: Case-only

TIME PERSPECTIVE: Retrospective

BIOSPECIMEN RETENTION: Samples without DNA

BIOSPECIMEN DESCRIPTION: Tissue samples obtained from Cooperative Human Tissue Network (CHTN)

STUDY POPULATION DESCRIPTION: Patients enrolled on P9754 and AOST0121 clinical trials

SAMPLING METHOD: Non-probability sample

PRIMARY OBJECTIVES:

I. To determine if there is differential expression of tumor factor (TF) among patients with osteosarcoma.

II. To determine if there is an association between overall survival and disease free survival and the extent of TF expression.

III. To determine if TF expression correlates with presence of gross metastatic disease at presentation, and development of subsequent metastases.

OUTLINE:

Tissue samples are analyzed for tumor factor expression levels by immunohistochemistry.

Eligibility criteria: Inclusion Criteria:

* Tissue samples from patients with osteosarcomas obtained from the CHTN:

  * P9754 clinical trial for patients with non-metastatic osteosarcoma
  * AOST0121 clinical trial for patients with metastatic or recurrent osteosarcoma

Primary outcomes:
measure: Prevalence of high TF expression
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Mark Ranalli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03091452: CArdioSurgEry Atrial Fibrillation Register
Official title: CArdioSurgEry Atrial Fibrillation Register - CASE-AF Register
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in whom atrial fibrillation is treated by cardiac surgical ablation

Brief summary: CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation is treated by cardiac surgical ablation.

Detailed description: CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation is treated by cardiac surgical ablation. In particular, the following questions should be answered:

* Indication: Which are the different indications for cardiac surgical ablation in patients with atrial fibrillation?
* How often and in which patients the different concepts of surgery and ablation procedures are used? At the same time, how often an intervention at the left atrial appendage is carried out?
* Safety: How secure is the cardiac surgical ablation of atrial fibrillation (periprocedural, during hospital stay and during the long-term follow up)?
* Effectiveness: How effectively is the cardiac surgical ablation of atrial fibrillation (procedural success)? How often are AF recurrences in the long-term follow up?
* What is the concommitant medical treatment after surgical ablation?

Eligibility criteria: Inclusion Criteria:

* Atrial fibrilation
* Treated by cardiac surgical ablation

Exclusion Criteria:

* Patient denies participation

Primary outcomes:
measure: Number of major bleeding events
timeFrame: 12 months
Secondary outcomes:
measure: Number of major adverse cardiac events
timeFrame: 12 months
measure: Complications during hospital stay
timeFrame: 12 months
Other outcomes:
Locations:
city: Munchen
country: Germany
facility: Klinikum Bogenhausen
state: Bayern
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann Kliniken
state: NRW
city: Hamburg
country: Germany
facility: Asklepios Harburg
Study officials:
affiliation: Asklepios Hamburg Harburg
name: Thorsten Hanke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05218252: Reconstruction of Hand Soft Tissue Defects
Official title: Reliability and Versatility of Posterior Interosseous Artery Flap in Reconstructing Hand Soft Tissue Defects.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hand Injuries
Keywords: Posterior interosseous artery flap
Hand soft tissue defects
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 15
Sex: ALL
Minimum age (years): 3
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of distally based posterior interosseous artery flap in reconstructing hand soft tissue defects that may result from trauma, extensive burns, tumor resection or congenital deformities.


Eligibility criteria: Inclusion Criteria:

1. Patients with complex defects over the dorsal and palmar aspect of the wrist and the hand up to the proximal interphalangeal joint level, the whole thumb, and the first web space.
2. Small to moderate hand defects resulting from post-traumatic raw areas, post-traumatic deformities, postburn deformities and scar, post tumor resection, and congenital hand deformity.
3. Availability of a healthy donor site.

Exclusion Criteria:

1. Patients with a major uncontrollable medical illness.
2. Chronic heavy smokers.
3. Traumatic injury to the donor site.
4. Complex defects of the hand beyond the PIP joint level.

Primary outcomes:
measure: Functional and aesthetic outcomes of posterior interosseous artery flap
timeFrame: 5 months from the end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
affiliation: Sohag University
name: Ahmed Talaat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04834752: Effect of H2 Receptor Antagonist and Proton Pump Inhibitor on the Positivity Rates and Clinical Outcomes of COVID-19
Official title: Effect of Histamine 2 Receptor Antagonist (H2RA) and Proton Pump Inhibitor (PPI) on the Positivity Rates and Clinical Outcomes of Coronavirus Disease-19 (COVID-19).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Proton pump inhibitor
H2 receptor antagonist
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Dong-A ST Co., Ltd.
First posted: 2021-04-08
Enrollment: 400000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who were tested for COVID-19 using real-time reverse transcriptase PCR assay of nasal and pharyngeal swabs were included. Data were obtained from the Korean national health insurance claims-based database (COVID-19 research dataset). Individuals with a Record of a new prescription of NSAID within 1 month of the test date were excluded because NSAID users for early pneumonia symptoms may initiated for PPIs or H2 blockers.

Brief summary: This retrospective cohort study aims to evaluate the effect of proton pump inhibitor (PPI) or histamine-2 receptor antagonist (H2RA) on the clinical outcomes and positivity rates of Coronavirus Disease-19 (COVID-19).

Detailed description: Previous researches on the association between the use of PPI and H2RA and the treatment and prevention of COVID-19 have reported inconsistent findings. This study aimed to evaluate the effect of H2 receptor antagonists and proton pump inhibitors on the clinical outcomes and positivity rates of COVID-19 using the Korean National Health Insurance (NHI) data. This is a retrospective cohort study using the NHI COVID-19 dataset, which includes health insurance data of individuals who underwent COVID-19 PCR test in South Korea. This study aims to evaluate the effect of the use of PPI and H2RA on the positivity rates and clinical outcomes of COVID-19.

Eligibility criteria: Inclusion Criteria:

* Individuals who were tested for COVID-19 using real-time reverse transcriptase PCR assay of nasal and pharyngeal swabs

Exclusion Criteria:

* Record of a new prescription of non-steroidal anti-inflammatory drugs (NSAID) within 1 month of the test date
* Patients who died within 48 hours after test.

Primary outcomes:
measure: COVID-19 test positivity
timeFrame: Through test completion, an average of 1 day
measure: Mortality
timeFrame: 60 days
Secondary outcomes:
measure: Intensive care unit admission rate
timeFrame: 60 days
measure: Mechanical ventilator application rate
timeFrame: 60 days
measure: Oxygen apply rate (Nasal prong, Facial Mask, High flow nasal cannula)
timeFrame: 60 days
measure: Rates of vasopressor and inotrope use
timeFrame: 60 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06791252: Genital Hygiene Education and Pregnancy
Official title: The Effect of Genital Hygiene Education Given to Pregnant Women Diagnosed with Urinary Tract Infection on Genital Hygiene Behavior and Self-Care Agency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genital Hygiene Behaviors
Self-Care Ability
Keywords: Midwife
pregnant
hygiene
self-care
urinary tract infections
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized controlled trial conducted with experimental and control groups
Primary purpose: PREVENTION

Brief summary: Genital hygiene behaviors are of great importance in preventing urinary tract infections, especially during pregnancy. The study was conducted to determine the effect of genital hygiene education given to pregnant women diagnosed with urinary tract infections on genital hygiene behavior and self-care ability. The hypotheses of this study were determined as follows:

H1a: Genital hygiene education affects genital hygiene behavior in pregnant women.

H1b: Genital hygiene education affects self-care ability in pregnant women.

Detailed description: Genital hygiene behaviors are of great importance in preventing urinary tract infections, especially during pregnancy. The study was conducted to determine the effect of genital hygiene education given to pregnant women diagnosed with urinary tract infection on genital hygiene behavior and self-care ability. The study was conducted in the gynecology and obstetrics clinics of a hospital in eastern Turkey between September 2021 and February 2022. Personal Information Form, Genital Hygiene Behaviors Scale and Self-Care Ability Scale were used to collect data. In the power analysis, the sample size was calculated as 80 pregnant women in each group (80 experimental, 80 control). Pregnant women in the experimental group received genital hygiene education in 4 sessions, while no intervention was applied to the control group. Descriptive statistical analyses and t-test in dependent-independent groups were used in the analysis of the data.

Eligibility criteria: Inclusion Criteria:

* All pregnant women who were literate, - Who had completed their pharmacological treatment (antibiotic treatment) for UTI according to medical records were included in the sample

Exclusion Criteria:

* - Those who had previously received training to increase genital hygiene behavior,
* Those who had a risky pregnancy,
* Those who were diagnosed with any health problems related to the pregnant woman and the fetus were not included in the study

Primary outcomes:
measure: genital hygiene behavior
timeFrame: 30 days
Secondary outcomes:
measure: Self-Care Ability
timeFrame: 30 days
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Malatya
Study officials:
References: