louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01548495: Autoantibodies Against Human Recombinant Erythropoietin in Myelodysplatic Syndrome Patients
Official title: Investigating Recombinant Human Erythropoietin (rHuEPO) Treatment Efficacy Depending on the Presence of Erythropoietin Autoantibodies in Myelodysplatic Syndrome (MDS) Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myelodysplatic Syndrome
Keywords: MDS
Autoantibodies
Erythropoietin
Autoantibodies in MDS patients treated with EPO
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MDS patient from meir health care center

Brief summary: The purpose of this study is to verify the presents of autoantibodies in serums of MDS serum patients who had an inadequate response or did not respond to Recombinant human erythropoietin (rHuEPO) treatment.

Detailed description: MDS are a heterogeneous group of hematologic disorders broadly characterized by cytopenias associated with a dimorphic and usually cellular bone marrow, and by consequent ineffective blood cell production. 85% of patients have a severe anemia which is Associated with lowering quality of life and Often requires blood transfusions. Historically, only stem cell transplantation offers cure. however, multiple new drugs have been approved for treatment, such as to Recombinant human erythropoietin (rHuEPO) treatment for dealing with the anemia. rHuEPO treatment can improve hematocrit level in 25% of patient which leaves the rest with the need of other treatment solution. Studies have shown presents of anti- rHuEPO in blood serums which followed Treatment of other diseases. These findings can indicate the possibility of the presence of antibodies in MDS patients as well.

Eligibility criteria: Inclusion Criteria:

* Followed up hematological patients
* Pateint recieving rHuEPO treatment (except control group)
* Pateint signed informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Correlate the Presence of Erythropoietin autoantibodies titer in MDS patients with an inadequate response (IR) to Human Recombinant Erythropoietin treatment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar- Saba
country: Israel
facility: Meir Medical center
Study officials:
References:
Clinical trial NCT05163795: Distal Femur Fracture Nonunion - Statistical Analysis Plan
Official title: Prediction of Fracture Nonunion Leading to Secondary Surgery in Patients With Distal Femur Fractures - Statistical Analysis Plan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femur Distal Fracture
Nonunion of Fracture
Keywords: Prediction
Distal femur fracture
Nonunion
Statistical analysis plan
Lead sponsor: Töölö Hospital
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 299
Sex: ALL
Minimum age (years): 16
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study is a retrospective cohort study conducted in level 1 trauma center at the Helsinki University Hospital with a catchment population of around one million for these fractures. All patients with a distal femur fracture treated at our institution between 2009 and 2018 were screened for eligibility.

Brief summary: Here the investigators describe the statistical analysis plan for the study assessing the prediction of fracture nonunion leading to secondary surgery in patients with distal femur fractures.

Detailed description: See attached PDF.

Eligibility criteria: Inclusion Criteria:

* Age \> 16 years
* AO/OTA type A or C distal femur fracture
* Fracture located on the metaphyseal area of the distal femur (square method)
* Operative treatment in the Helsinki University Hospital with a distal femur anatomic lateral locking plate
* Operative treatment within 1 month after trauma
* Operative treatment between years 2009 and 2018

Exclusion Criteria:

* Stress fracture
* Pathological fracture
* An epicondylar or subchondral fracture
* A ligament sprain in distal femur
* Treatment with a double-plating method or with both plate and nail
* Non-surgical treatment and patients who died before the treatment
* Treatment with an unconventional plate (other than distal femur plate)
* Patients whose follow-up criteria not fulfilled

Primary outcomes:
measure: Reoperation
timeFrame: Within 36 months after the initial trauma
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital
Study officials:
affiliation: Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
name: Jan Lindahl, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02158195: Immunopathology of Autoimmune Hemolytic Anemia
Official title: Immunopathology of Autoimmune Hemolytic Anemia: an Open, Prospective and Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Hemolytic Anemia
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 27
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with warm primary or secondary Autoimmune Hemolytic Anemia

Brief summary: Autoimmune hemolytic anemia (AIHA) is an auto-immune disease mediated by specific antibodies targeting red blood cells. Its pathogenesis is not completely understood, and the role of T cells have been rarely studied.

The aim of this study is to compare the frequency of circulating T cells, T cell polarization and functions, notably regulatory T cells, during warm AIHA by comparison to healthy controls.

The role of treatments, such as steroids, will also be determined in patients with warm AIHA.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with primary warm Autoimmune Hemolytic Anemia (wAIHA)
* Secondary AHAI (infections, hematological diseases, systemic diseases)
* Naive of treatment for hemolytic anemia or in relapse
* Older than 16
* Able to understand written and spoken French
* who have provided written informed consent
* INCLUSION CRITERIA for CONTROLS
* Persons without auto-immune disease, cancer or active infection.
* Older than 16
* Able to understand written and spoken French
* who have provided written informed consent

Exclusion Criteria:

* Cold agglutinin disease
* Pregnancy
* Persons without national health insurance

Exclusion Criteria for Controls:

* Subjects treated with corticosteroids or immunosuppressants
* Pregnancy
* Persons without national health insurance

Primary outcomes:
measure: physiological parameter : blood level of regulatory T cells (Treg, CD4+CD25HighFoxp3+)
timeFrame: Change from baseline to 3 months
measure: physiological parameter : percentage of inhibiting LT proliferation inhibition
timeFrame: Change from baseline to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Chalon-sur-Saône
country: France
facility: CH de Chalon-sur-Saône
city: Dijon
country: France
facility: CHU de DIJON
city: Metz
country: France
facility: CH de METZ
city: Mâcon
country: France
facility: CH de Mâcon
Study officials:
References:
citation: Audia S, Bach B, Samson M, Lakomy D, Bour JB, Burlet B, Guy J, Duvillard L, Branger M, Leguy-Seguin V, Berthier S, Michel M, Bonnotte B. Venous thromboembolic events during warm autoimmune hemolytic anemia. PLoS One. 2018 Nov 8;13(11):e0207218. doi: 10.1371/journal.pone.0207218. eCollection 2018.
Clinical trial NCT06173895: A Relative Bioavailability Study of LY3454738 in Healthy Participants
Official title: A Phase 1, Open-Label Study to Determine the Relative Bioavailability of LY3454738 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to look at the amount of the study drug, LY3454738 that gets into the blood stream and how long it takes the body to get rid of it when given under the skin comparing a test formulation versus a reference formulation in healthy participants. The study will also evaluate the safety and tolerability of LY3454738 and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately up to 17 weeks, including screening period.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy as determined by medical history and physical examination.
* Have body mass index (BMI) between 18.0 and 28.0 kilograms per meter squared (kg/m²), inclusive, at screening.

Exclusion Criteria:

* Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product; or of interfering with the interpretation of data.
* Had any surgical procedure (except for minor surgery requiring local or no anesthesia and without any complications or sequelae) within 12 weeks prior to screening or intend to during the study.
* Show evidence of active or latent TB.
* Have one of the following infections: hepatitis B virus or human immunodeficiency virus (HIV).
* Participants must not be currently participating in or completed a clinical trial within the last 30 days

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3454738
timeFrame: Predose on day 1 up to 85 days post dose
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3454738
timeFrame: Predose on day 1 up to 85 days post dose
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON Early Phase Services
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04187495: Study of MAX-40279 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)
Official title: A Phase I Study for Tolerance and Pharmacokinetic Characteristic of MAX-40279 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: AML
Lead sponsor: Maxinovel Pty., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-40279-01 in patients with Relapsed or Refractory AML.

Detailed description: This is a two-part study comprised of a dose escalation part and a dose expansion part.

Eligibility criteria: Inclusion Criteria:

* Males and/or females over age 18.
* Subject has morphologically documented relapsed or refractoryprimary AML as defined by the World Health Organization (WHO) 2016 criteria for which no established standard therapy is available.
* ECOG performance status of 0 to 2.
* Persistent chronic clinically significant non-hematological toxicities from prior treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, HSCT, or surgery) must be Grade ≤ 1.
* Any anti-tumor treatment with radiation therapy, surgery, or immunotherapy wihtin 2 weeks prior to trial entry.
* Life expectancy of at least 3 months.
* Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for six months following the last dose of study drug.

Exclusion Criteria:

* Disease diagnosis of acute promyelocytic leukemia.
* Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
* Previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years at the trial entry.
* Laboratory values not within the Protocol-defined range.
* Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: 8 weeks
measure: Maximum tolerated dose (MTD）
timeFrame: 4 weeks
measure: Phase II dose (RP2D)
timeFrame: 4 weeks
Secondary outcomes:
measure: Tmax
timeFrame: Approximately 4 weeks
measure: Cmax
timeFrame: Approximately 4 weeks
measure: AUC
timeFrame: Approximately 4 weeks
measure: t1/2
timeFrame: Approximately 4 weeks
measure: Objective response rate (ORR)
timeFrame: 1 months (anticipated)
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT01846195: Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Patients During a Blood Draw
Official title: Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Adult Patients During a Blood Draw
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Loss
Keywords: blood loss
Lead sponsor: Zynex Monitoring Solutions
Sponsor class: INDUSTRY
Collaborators: name: DTarget
First posted: 2013-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Non-invasive monitoring to measure changes in blood volume.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Between 18-35 years of age
* Weight between 130-200 pounds

Exclusion Criteria:

* Known cardiac disease
* Recent caffeine intake
* Tobacco use in the (4) hours prior to screening
* Infection
* Pregnancy
* Hemoglobin \<13.5 g/dl

Primary outcomes:
measure: Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw
timeFrame: At study completion (completion of blood draw)
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Premier Research Group
state: Utah
Study officials:
affiliation: Premier Research Group plc
name: John Ziegler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03828695: Uterocervical Angle in Idiopathic Polyhydramnios
Official title: Efficacy and Efficiency of Uterocervical Angle for Prediction of Preterm Labor in Patients With Idiopathic Polyhydramnios: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Labor
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: To evaluate the performance of uterocervical angle (UCA) in the prediction of preterm labor in isolated polyhydramnios


Eligibility criteria: Inclusion Criteria:

* isolated polyhydramnios pregnancies
* no previous systemic illnesses

Exclusion Criteria:

* abnormal Pap smear
* previous cesarean section
* history of dilatation and curettage (D\&C)
* history of loop electrosurgical excision procedure (LEEP) and cervical conization

Primary outcomes:
measure: prediction of preterm birth by uterocervical angle in patients with idiopathic polyhydramnios.
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sanlıurfa
country: Turkey
facility: Nefise N YENIGUL
Study officials:
References:
Clinical trial NCT01294995: Effect of Short-term Chinese Tea-flavor Liquor Consumption
Official title: Phase 1 Study of Chinese Tea-flavor Liquor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Diseases
Keywords: short term consumption
Chinese liquor
serum lipids
uric acid
inflammation biomarkers
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Guizhou Meijiao Co., Ltd
First posted: 2011-02-14
Enrollment: 45
Sex: ALL
Minimum age (years): 23
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Human studies of Chinese liquor are sparse. The investigators hypothesize that short-term Chinese Tea-flavor liquor (TFL) consumption may be beneficial to inflammation biomarkers and CVD risk factors. Guizhou Meijiao Liquor (GML) is a traditional Chinese liquor, fermented from sorghum, corn, sticky rice, wheat and rice, while TFL is a novel Chinese liquor fermented from above 5 grains plus green tea.

Forty-five volunteers(23 males, 22 females) were selected to participate a paralleled randomized trial drinking 30 mL two kinds of Chinese liquors: TFL and GML respectively with meal every day for 28 days. Serums of volunteers were collected for analyzing serum lipids, inflammation biomarkers and CVD risk factors.

TFL could significantly decrease systolic blood pressure of males, but increase diastolic blood pressure of females. TFL could also decreased blood lipid of volunteers, especially for females. Both liquor significantly decrease serum uric acid and glucose in males and females. The effect of the two liquors on inflammation biomarkers were complicated and needs further research work.

TFL may possess more beneficial effect on CVD risk factors than GML probably because of the special fermentation products of green tea with other grains.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteers

Exclusion Criteria:

* Subjects with a history of liver disease, diabetes, or heart disease
* Smokers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of food science and nutrition
state: Zhejiang
Study officials:
References:
Clinical trial NCT01530295: Biochemical Recurrence Rate of Radical Prostatectomy Combined With Neoadjuvant and Adjuvant Chemotherapy in High Risk Prostate Cancer
Official title: Biochemical Recurrence Rate of Radical Prostatectomy Combined With Neoadjuvant and Adjuvant in Patients With High Risk Locallized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 70
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Effect of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in Patients with High Risk Prostate Cancer.

The purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and prednisone are effective in the treatment of high risk localized prostate cancer.

Detailed description: The purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and prednisone are effective in the treatment of high risk localized prostate cancer.

Eligibility criteria: Inclusion Criteria:

* Prostate Cancer
* PSA \> 20 OR
* Clinical Stage \> T2C OR
* GS \> 7

Primary outcomes:
measure: biochemical recurrence rate of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in Patients with High Risk Prostate Cancer
timeFrame: 2 Years After RRP
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jungmin Lee
Study officials:
affiliation: Asan Medical Center
name: hanjong Ahn, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06728995: Renal Function Prediction in Living Donor Transplant Using Baseline Data
Official title: Prediction of Recipient Renal Function in Living Donor Kidney Transplantation Using Baseline Characteristics and Donor Renal Volume
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Transplanted Recipients
Kidney Function
Keywords: renal transplantation
kidney volume
predictive model
machine learning
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 3500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were recruited from Seoul National University Hospital, Severance Hospital, and Bundang Seoul National University Hospital, encompassing recipients and donors involved in living-donor kidney transplantation.

Brief summary: This study aims to predict early post-transplant kidney function in living donor kidney transplant recipients using baseline characteristics of donors and recipients. The study involves analyzing pre-transplant data to develop a machine learning model that predicts serum creatinine levels one year post-transplant. This research may improve decision-making and outcomes for transplant patients


Eligibility criteria: Inclusion Criteria:

- Recipients and donors of living-donor kidney transplantation.

Exclusion Criteria:

* Donors or recipients with follow-up durations of less than 1 year.
* Recipients who received simultaneous organ transplantation in addition to kidney transplantation.

Primary outcomes:
measure: Lowest Serum Creatinine Level
timeFrame: Within one year post-transplant.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: