louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04343547: Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With DWC202001 and DWC202002 in Healthy Male Adults
Official title: A Randomized, Open Label, Single/Multiple Dose, Crossover Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With DWC202001 and DWC202002 in Healthy Male Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2020-04-13
Enrollment: 34
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate drug-drug interaction by comparing the pharmacokinetics (PK)/pharmacodynamics (PD), safety, and tolerability of single/multiple doses of DWP16001 , DWC202001 and DWC202002 alone or in combination in healthy male adults.


Eligibility criteria: Inclusion Criteria:

1. Healthy male adults ≥ 19 and ≤ 50 years of age at the time of the screening procedure
2. 55.0 kg ≤ body weight ≤ 90.0 kg and 18.0 ≤ body mass index (BMI) ≤ 27.0
3. Voluntarily decided to participate in the study and provided written consent prior to the screening procedure after receiving a detailed explanation on this study and fully understanding the information
4. Is eligible to participate in the study at the discretion of the investigator by a physical examination, laboratory test, and medical history questionnaire, etc.

Exclusion Criteria:

1. Presence or prior history of a clinically significant hepatic, renal, nervous, respiratory, endocrine, hematologic and oncologic, cardiovascular, urogenital, psychiatric disorder
2. Presence or prior history of a gastrointestinal disorder (e.g., gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.), or prior history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the safety and PK/PD assessment of the study drug.
3. Hypersensitivity to, or history of clinically significant hypersensitivity to drugs including DWP16001 and other drugs of the same class (SGLT2 inhibitors), drugs including gemigliptin and other drugs of the same class, metformin and other drugs (aspirin, antibiotics, etc.)
4. Considered ineligible for the study by the investigator for reasons including laboratory test results

Primary outcomes:
measure: Cmax of DWP16001
timeFrame: 0-72 hours
measure: AUClast of DWP16001
timeFrame: 0-72 hours
measure: Cmax,ss of DWC202001 and DWC202002
timeFrame: 0-72 hours
measure: AUCτ,ss of DWC202001 and DWC202002
timeFrame: 0-72 hours
Secondary outcomes:
measure: Tmax of DWP 16001, DWC202001 and DWC202002
timeFrame: 0-72 hours
measure: T1/2 of DWP 16001, DWC202001 and DWC202002
timeFrame: 0-72 hours
measure: CL/F of DWC202001 and DWC202002
timeFrame: 0-72 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT02195947: Antagonist Protocol in Poor Responders
Official title: Does the Addition of Growth Hormone to the Invitro Fertilization/ Intracytoplasmic Sperm Injection Antagonist Protocol Improve Outcome in Poor Responders? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Female Infertility Due to Diminished Ovarian Reserve
Keywords: Growth hormone
IVF/ICSI
Poor responder
Antagonist protocol
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-07-21
Enrollment: 141
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of use of the growth hormone with antagonist protocol on the outcome of the IVF/ICSI cycles in poor responders.

Detailed description: Two groups of poor responder female patients planned to receive the antagonist IVF/ICSI protocol are randomized to whether or not to add growth hormone to their protocol.

Eligibility criteria: Inclusion Criteria:

* females fulfilling the criteria of the ESHRE consensus 2011:
* at least two of the following three features must be present:
* dvanced maternal age (≥40 years) or any other risk factor for POR
* previous POR (≤3 oocytes with a conventional stimulation protocol)
* an abnormal ovarian reserve test (i.e. AFC ,5-7 follicles or AMH ,0.5 -1.1 ng/ml).

Exclusion Criteria:

* women who suffer from any other cause of infertility other than poor ovarian reserve
* refusal of the patient to consent for using her data in the study.

Primary outcomes:
measure: Live birth rate
timeFrame: Up to 9 months
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: Up to 5 weeks
Other outcomes:
measure: Chemical pregnancy rate
timeFrame: 5 weeks
measure: Early miscarriage rate
timeFrame: Up to 12 weeks
measure: Ongoing pregnancy rate
timeFrame: Up to 12 weeks
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Aini
Study officials:
affiliation: Cairo University
name: Yomna A Bayoumi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bassiouny YA, Dakhly DMR, Bayoumi YA, Hashish NM. Does the addition of growth hormone to the in vitro fertilization/intracytoplasmic sperm injection antagonist protocol improve outcomes in poor responders? A randomized, controlled trial. Fertil Steril. 2016 Mar;105(3):697-702. doi: 10.1016/j.fertnstert.2015.11.026. Epub 2015 Dec 13.
Clinical trial NCT00724477: Retrospective Evaluation of the Percentage of Subjects Who Have Reached Their LDL-C Objectives After Treatment With INEGY (Study P05103)(COMPLETED)
Official title: PRAGMATIC (This is the True Official Title of the Protocol for This Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 1663
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects suffering from primary hypercholesterolemia that are not controlled by statins as a monotherapy, and are treated with INEGY

Brief summary: The main objective of this study is to determine the percentage of patients who met the low-density lipoprotein cholesterol (LDL-C) objective with INEGY, that were not under statin monotherapy treatment.

Detailed description: The type of patient sampling used was consecutive patient sampling

Eligibility criteria: Inclusion Criteria:

* man or woman aged over 18;
* patient suffering from primary hypercholesterolemia;
* patient justifying treatment with INEGY® (2nd intention);
* patient currently treated with INEGY® for at least 4 weeks;
* patient with a lipid profile before treatment with INEGY®, documenting a level of LDL-C exceeding the therapeutic objective under treatment with a statin as monotherapy;
* patient with an evaluation of lipid disorder (EAL) treated with INEGY®, performed within 1 to 3 months of starting treatment.

Exclusion Criteria:

* patient not previously treated with a statin;
* patient previously treated with a combination of hypolipemics;
* patient treated with INEGY® as first intention;
* patient treated with INEGY® for less than 4 weeks;
* patient already included in this study.

Primary outcomes:
measure: Number of Participants Reaching the Targeted LDL-C Levels
timeFrame: 1 to 3 months after starting treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06587477: Testicular Function and Semen Quality in Male Childhood and Adolescent Cancer Survivors
Official title: Effect of Cancer Treatment on Testicular Function and Semen Quality in Male Childhood and Adolescent Cancer Survivors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer, Treatment-Related
Late Effect
Semen Analysis
Keywords: cancer treatment
testicular function
semen quality
cancer survivors
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
name: Prince of Wales Hospital, Shatin, Hong Kong
name: Hong Kong Children's Hospital
First posted: 2024-09-19
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Target participant Population

* The target population for the trial will be men who have received chemotherapy and/ or radiotherapy for cancer diagnosed when they were \< 18 years old.
* Aged-matched controls from men attending the Family Planning Association for premarital check-up

Brief summary: Cancer treatment can affect the testicular function, including sperm and hormonal functions. The aim of this study is to assess the testicular function and semen quality in young men who recover from childhood and adolescent cancer in Hong Kong. This can provide more information for pre-treatment counselling as well as improve post treatment survivorship care. The testicular function will be compared to aged-matched controls from men attending the Family Planning Association for premarital check-up.

Detailed description: This is a cohort observational study. The target population for the trial will be men who have received chemotherapy and/ or radiotherapy for cancer diagnosed when they were \< 18 years old, currently \> 18 years old to 50 years old and cancer in remission for at least 2 years. The testicular function, including sperm and hormonal functions, will be compared with aged-matched controls from men attending the Family Planning Association for premarital check-up.

Eligibility criteria: Inclusion Criteria:

* Men who have received chemotherapy and/ or radiotherapy for cancer diagnosed when they were \< 18 years old.
* \> 18 years old to 50 years old
* Cancer in remission for at least 2 years

Exclusion Criteria:

* Unable to ejaculate by masturbation to provide semen samples
* Cryptorchidism, testicular cancer, history of vasectomy
* On testosterone replacement therapy
* Refusal to join the study

Primary outcomes:
measure: Sperm concentration
timeFrame: up to 3 months
Secondary outcomes:
measure: Semen parameters
timeFrame: up to 3 months
Other outcomes:
measure: Testicular volume
timeFrame: up to 3 months
measure: Hormonal profile
timeFrame: up to 3 months
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
References:
Clinical trial NCT04506047: Acute and Long-term Outcomes of Patients With Acute Myocardial Infarction Treated With PCI
Official title: Acute and Long-term Outcomes of Patients Presenting With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Coronary Artery Disease
Keywords: AMI
Lead sponsor: Clinical Centre of Serbia
Sponsor class: OTHER
Collaborators: name: Institute of Cardiovascular Diseases, Vojvodina
name: Clinical Hopital Center Zemun
name: University Hospital Medical Center Bezanijska Kosa
name: Clinical Centre of Kragujevac
name: Clinical Hospital Center Zvezdara
First posted: 2020-08-10
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: This registry is based on consecutive patients with the initial diagnosis of acute myocardial infarction on admission to hospital, who are referred to invasive treatment, i.e. invasive coronary angiography with an intention to perform percutaneous coronary intervention. The study population will include both retrospective, multi-center registry data starting with the year 2009, and the prospectively enrolled patients according to the same pre-specified, broad inclusion/exclusion criteria. The underlying intention is to short- and long-term outcomes of a large population of unselected, real-world patients presenting with AMI and treated with PCI.

Brief summary: Randomized studies may often be burdened by the selective nature of patient inclusion thus not reflecting real-world outcomes. This is evident from the discrepancy in the mortality rates reported in major randomized trials enrolling patients with acute myocardial infarction (AMI), as compared with registry data.

The primary objective of this observational study is to assess short- and long-term outcomes of unselected, real-world patients presenting with AMI and treated with contemporary percutaneous coronary intervention (PCI).


Eligibility criteria: Inclusion Criteria:

* Patients with acute myocardial infarction referred to catheterization laboratory for percutaneous coronary intervention

Exclusion Criteria:

* Initial acute myocardial infarction diagnosis not confirmed
* Patients with acute myocardial infarction not undergoing invasive coronary angiography

Primary outcomes:
measure: Rate of all-cause mortality
timeFrame: 1 year
Secondary outcomes:
measure: Rate of all-cause mortality
timeFrame: 5 years
measure: Rate of cardiovascular mortality
timeFrame: 5 years
Other outcomes:
measure: Rate of myocardial infarction
timeFrame: 5 years
measure: Rate of repeat revascularization
timeFrame: 5 years
measure: Rate of stroke
timeFrame: 5 years
measure: Rate of new or worsening heart failure
timeFrame: 5 years
measure: Rate of new or worsening heart failure
timeFrame: 1 year
Locations:
city: Belgrade
country: Serbia
facility: Clinical Centre of Serbia, Department of Cardiology
Study officials:
References:
Clinical trial NCT02281877: Alterations in Muscle After Total Knee Arthroplasty
Official title: Alterations in Skeletal Muscle Gene Expression Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Total Knee Arthroplasty (TKA)
Gene Expression
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2014-11-04
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goals of this work are: 1) to elucidate alterations in gene expression and downstream protein synthesis 2 weeks after Total Knee Arthroplasty (TKA) to better explain quadriceps muscle atrophy after TKA and 2) understand the mechanisms responsible for improved maintenance of muscle strength with Neuromuscular Electrical Stimulation (NMES) utilization. Furthermore, this investigation seeks to expand previous findings regarding attenuation of strength and functional performance deficits with NMES application to better understand how altered gene expression influences muscle function.


Eligibility criteria: Inclusion Criteria:

* 50 to 75 years of age
* Scheduled for unilateral TKA at University of Colorado Hospital
* Diagnosed with osteoarthritis
* Cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study

Exclusion Criteria:

* Neurological, vascular or cardiac problems that significantly limit function
* BMI \> 35
* Testosterone supplementation
* Pregnancy
* Anticoagulant therapy

Primary outcomes:
measure: Catabolic gene expression
timeFrame: Change in gene expression from immediately pre surgery to 2 weeks after surgery
Secondary outcomes:
measure: Changes in quadriceps strength
timeFrame: 3 days Pre operative and 2 weeks post operative
measure: Changes in quadriceps size
timeFrame: 3 days Pre operative and 2 weeks post operative
measure: Changes in quadriceps activation
timeFrame: 3 days Pre operative and 2 weeks post operative
measure: Functional Performance Measures (4 meter walk test, timed up and go, stair climbing test)
timeFrame: 3 days Pre operative and 2 weeks post operative
measure: Anabolic Gene Expression
timeFrame: Immediately pre surgery to 2 weeks after surgery
measure: Muscle Fiber Cross-Sectional Area
timeFrame: Immediately pre surgery to 2 weeks after surgery
measure: Changes in neural cell adhesion molecule (NCAM) concentration
timeFrame: Preop and 2 weeks postop
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Univeristy of Colorado Anschutz Medical Campus
state: Colorado
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Victor Cheuy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00824577: Heart Rate Variability in Chronic Kidney Disease Patients
Official title: Heart Rate Variability in Chronic Kidney Disease Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Heart Rate Variability
Keywords: heart rate variability
autonomic function
heart function
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-01-19
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: peritoneal dialysis: peritoneal dialysis patient lasting for more than 3 months

Brief summary: Use 24hr Holter ECG, ultrasound and cardiac fibrosis markers in the chronic kidney disease patients

Detailed description: 24hr Holter examination is a non-invasive tool in detecting and diagnosing cardiac arrhythmia. Moreover, Heart rate variability has been proven to been an important prognostic factor in many cardiovascular diseases. The traditional linear analysis of heart rate variability proved to predict clinical outcome in myocardial infarction patients. The more delicate non-linear analysis in heart rate variability is one of the hot topics in the world.

Despite some biochemical values like WBC counts, platelet counts, BUN, creatinine, lactate, clinical vital parameters like blood pressure, heart rate, and oxygenation have been used to predict clinical outcome in chronic renal disease(CKD) patients, the application is still limited. It is an international interest to find a more safe and simple technique to identify important prognostic factors in CKD patients. Our project aimed to recruit these CKD patients from our hospital and conduct a cross-sectional study. Cardiac ultrasonography and 24hrs Holter will be arranged. Linear and non-linear analysis of heart rate variability will be performed and serum marker that influence prognosis like WBC count, platelet count, lactate, BUN, creatinine, fibrosis marker and adiponectin will be checked. Short term and long term outcome was followed and identify important prognostic factors to improve and detect clinical prognosis.

Eligibility criteria: Inclusion Criteria:

* peritoneal dialysis more than 3 months

Exclusion Criteria:

* pregnancy 2. received CT in recent 3 months

Primary outcomes:
measure: heart rate variability, heart function, PET, Kt/V
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT02532777: The Research of Standard Diagnosis and Treatment for HSPN in Children
Official title: The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Henoch-Schoenlein Purpura Nephritis
Lead sponsor: Nanjing Children's Hospital
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN in children.

Detailed description: Henoch-Schonlein purpura nephritis (HSPN) is one of the most common complications of Henoch-Schonlein purpura, and has become one of the main causes of chronic kidney disease in children. However, the diagnosis and treatment of HSPN is still based on the clinical experience, lacking of evidence-based support. This study is performed to explore the biological marker for early prediction of the prognosis and evaluate the efficacy and safety of various measures in the treatment of HSPN in children.

The patients who are proved to get HSPN by renal biopsy will be given prednisone 2mg/kg/d, and randomized to receive cyclophosphamide pulse i.v.,mycophenolate mofetil p.o. or leflunomide p.o., we will follow up them for about 2.5 years and compare the efficacy and safety of these measures by monitoring several indexes.

Eligibility criteria: Inclusion Criteria:

* Renal biopsy proved HSPN Proteinuria ≥ 50 mg/kg/d

Exclusion Criteria:

* The children with congenital diseases Proteinuria \< 50 mg/kg/d

Primary outcomes:
measure: Disappearance of proteinuria
timeFrame: 30 mo
Secondary outcomes:
measure: Disappearance of hematuria
timeFrame: 30 mo
measure: Renal function
timeFrame: 30 mo
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Children's Hospital
state: Jiangsu
Study officials:
affiliation: Department of Nephrology, Nanjing children's hospital
name: Aihua Zhang, M.D.
role: STUDY_CHAIR
References: