louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05255094: A Study to Evaluate the Efficacy and Safety of AK102 in Patients With Hyperlipidemia
Official title: A Phase 3 Clinical Study Evaluating the Efficacy and Safety of AK102 in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2022-02-24
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled phase 3 clinical study evaluating the efficacy and safety of AK102 in patients with primary hypercholesterolemia and mixed hyperlipidemia.

Detailed description: This is a Phase 3 clinical study to evaluate the efficacy and safety of AK102, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), in subjects with primary hypercholesterolemia and mixed hyperlipidemia.

Eligibility criteria: Inclusion Criteria:

1. Subject understand and voluntarily sign the written Inform Consent Form (ICF).
2. Male or female ≥ 18 to ≤ 80 years of age.
3. The fasting serum LDL-C level of subjects did not meet the treatment goal after at least 4 weeks of stable lipid-lowering background treatment.
4. TG ≤ 4.5 mmol/L (400 mg/dl).

Exclusion Criteria:

1. Known homozygous familial hypercholesterolemia.
2. Received PCSK9 inhibitors within 6 months before randomization.
3. Known sensitivity to PCSK9 inhibitors and any substances to be administered.
4. Severe renal dysfunction.
5. Previously received organ transplantation.
6. Uncontrolled hypothyroidism or hyperthyroidism.
7. Uncontrolled hypertension.
8. Known hyperlipidemia secondary to comorbidity, including nephrotic syndrome, cholestatic liver failure, etc.
9. History of malignancy of any organ system within the past 5 years.
10. Pregnant or lactating women.

Primary outcomes:
measure: Percentage change from baseline of serum LDL-C level
timeFrame: At week 12
Secondary outcomes:
measure: Percentage change from baseline of serum TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels
timeFrame: Week 0-12
measure: The incidence and severity of adverse events (AE)
timeFrame: Week 0-12
measure: To evaluate the population pharmacokinetic (PK) characteristics of AK102，such as AK102 concentration
timeFrame: Week 0-12
measure: Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity
timeFrame: Week 0-12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
References:
Clinical trial NCT05486494: Spine Registry University Hospital of Cologne- Department of Orthopedics
Official title: Former Spine Tango Registry Now DWG Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Outcome, Fatal
Spondylodiscitis
Vertebral Osteomyelitis
Keywords: Quality of Life, Treatment Failure, Relapse, Spondylodiscitis, Vertebral Osteomyelitis
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Within all patients spondylodiscitis/ vertebral osteomyelitis patients were analyzed in detail.

Brief summary: Between January 2008 and December 2020 all patients with spine diseases were registered prospectively in the former European Spine Tango registry and later german DWG registry at the department of orthopedics and trauma at the university of cologne.

Detailed description: The following data were prospectively collected after enrollment: age, sex, body mass index (BMI), length of hospital stay, affected spine segment, previous surgical procedures on the spine, conservative or operative treatment including type of surgical treatment and American Society of Anesthesiologists (ASA) Physical Status Classification System.

In addition the following quality of life scores were collected: Oswestry Disability Score (ODI), Core Outcome Measures Index(COMI), Short Form- 36 (SF- 36) and Euroqol- 5D (EQ- 5D).

Eligibility criteria: Inclusion Criteria:

* Spine disease

Exclusion Criteria:

* younger than 18 years

Primary outcomes:
measure: Quality of Life Data after surgery
timeFrame: 2008- 2020
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Cologne
name: Ayla Yagdiran, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05810194: Retrospective Cohort Study Comparing a Novel Gel Dressing vs SoC in the Treatment of Radiation Dermatitis
Official title: Retrospective Cohort Study Comparing a Novel Silicone Gel Wound Dressing vs Standard of Care in the Treatment of Radiation Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation Dermatitis
Lead sponsor: Stratpharma AG
Sponsor class: INDUSTRY
First posted: 2023-04-12
Enrollment: 344
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: Head and neck cancer patients treated with radiation therapy at UCLA from 2010 to 2022

Brief summary: Routinely collected data on radiation-induced skin toxicity from 2010 to 2022 will be retrospectively analyzed. Data will be split into two cohorts: patients that received 1) StrataXRT and 2) standard of care. The incidence of grade ≥ 2 radiation dermatitis, the time to onset of grade ≥ 2 radiation dermatitis, the radiation dose at onset of grade ≥ 2 radiation dermatitis, the incidence of moist desquamation and the number of treatment interruptions will be compared between the cohorts.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Head and Neck cancer treated with radiation therapy with or without chemotherapy
* Fractionated courses including at least 30 fractions (treatments)
* Minimum of 18 completed radiation treatments
* Radiation dose: \> 50 Gy
* Radiation technique: IMRT
* Radiation equipment: TrueBeam or Tomotherapy

Exclusion Criteria:

* Prior radiation to the treatment area
* Patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis.
* Patients undergoing SBRT
* Patients with existing rashes or wounds in the target region or radiation therapy at RT start
* Patients receiving hypofractionation
* Patient receiving bolus

Primary outcomes:
measure: CTCAE for Radiation Dermatitis
timeFrame: 5 weeks
Secondary outcomes:
measure: CTCAE for Hyperpigmentation
timeFrame: 5 weeks
measure: Number of patients requiring burn cream application
timeFrame: 5 weeks
measure: Interval between radiotherapy start and burn cream application
timeFrame: 5 weeks
measure: Number of patients requiring Mepilex application
timeFrame: 5 weeks
measure: Interval between radiotherapy start and Mepilex application
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California
state: California
Study officials:
References:
Clinical trial NCT01997294: Sequential Therapy of Atorvastatin Improve Outcomes of ST-elevated Acute Myocardial Infarction
Official title: Sequential Therapy of Atorvastatin Improving Tissue Reperfusion and Clinical Outcomes of ST-elevated Acute Myocardial Infarction Study（The STRAIT Study）
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: sequential therapy
atorvastatin
acute myocardial infarction
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Statins have been approved to benefit patients underwent percutaneous coronary intervention (PCI). The current study is designed to evaluate the effectiveness and safety of Sequential Therapy of Atorvastatin in patients with ST-elevated myocardial infarction and receive PCI treatment.


Eligibility criteria: Inclusion Criteria:

* Sighed informed consent
* Diagnosised as acute myocardial infarction
* Time frame less than 12 hours since the occurance of chest pain
* Aggred to receive sirolimus-eluted coronary stents
* Patients willing to accepte follow-up

Exclusion Criteria:

* Allegy to statins or with a history against statin therapy
* Allegy to any products that will be used during PPCI
* Disagreed to receive PPCI and other related therapy
* Existing sever liver dysfuntion that statins can not be used according to the guildlines
* Sever kidney dysfunction (creatinine \>3mg/dl or eGFR\<30ml/min)
* Sever left ventricular dysfunction (Killip grade 3)
* Patients are currently taking medicine that may influence the use of statin
* Patients with a history of alcohol abuse or durg abuse
* Woman during pregnancy or lactation
* Patients who has attended other clinical trials
* Patients who has received PCI or CABG previously
* Patients who can not agree to accept study protocol
* Other conditions that may not sutible for the current study

Primary outcomes:
measure: Major Adverse Events (MACE) Occourance Rate
timeFrame: 30 days
Secondary outcomes:
measure: Secondary Endpoints
timeFrame: 12 months
Other outcomes:
measure: Safty Endpoints
timeFrame: 12 months
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Dept. of Cardiology
state: Shanghai
Study officials:
affiliation: Institute of Cardiovascular Diseases, School of Medicine, Shanghai Jiao Tong University
name: Weifeng Shen, MD. PhD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04233294: Addition of Chidamide to the Combination Treatment of Decitabine Plus Camrelizumab in Combination Treatment Resistant/Relapsed Patients With Classical Hodgkin Lymphoma
Official title: Addition of Chidamide to the Combination Treatment of Decitabine Plus Camrelizumab in Combination Treatment Resistant/Relapsed Patients With Classical Hodgkin Lymphoma: an Open-label, Single Arm, Phase II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II clinical trial for Decitabine plus Camrelizumab resistant/relapsed patients with Hodgkin Lymphoma. The purpose is to evaluate the efficacy and safety of the combination therapy of Chidamide plus Decitabine Plus Camrelizumab.


Eligibility criteria: Inclusion Criteria:

1. Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
2. 12 to 75 years of age.
3. ECOG performance of less than 2.
4. Life expectancy of at least 3 months.
5. Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria.
6. Subjects must be relapsed or resistant for the treatment of Decitabine plus Camrelizumab. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
7. Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in one month .
4. Prior organ allograft.
5. Women who are pregnant or breastfeeding.
6. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Primary outcomes:
measure: ORR
timeFrame: 3 years
measure: Adverse effects
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Biotherapeutic Department of Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04943094: Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy
Official title: Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-muscle Invasive Bladder Cancer
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with primary non-muscle invasive bladder cancer or who are diagnosed with their first or second recurrence.

Brief summary: The aim is to evaluate and compare treatment strategies for non-muscle invasive bladder cancer. Furthermore, the impact of intravesical instillations on bladder function will be examined by urodynamic examination both prior to and following instillation therapy.


Eligibility criteria: Inclusion Criteria:

* non-muscle invasive bladder tumour

Exclusion Criteria:

* more than one previous bladder tumour recurrence
* muscle invasive bladder cancer (at baseline or prior to inclusion)
* utilization of urinary catheter
* have had heart valve replacement performed
* pregnant or lactating

Primary outcomes:
measure: Change in urodynamic specifics (bladder compliance, detrusor overactivity, maximal cystometric capacity)
timeFrame: examined at time 0 and after six months
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Jørgen B. Jensen, DMSc, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00204594: Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28
Official title: Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malignant Melanoma
Keywords: mRNA
vaccination
melanoma
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 1
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: Phase I/II clinical trial to analyze safety and efficiency of intralesional application of the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic melanoma stage III/IV and unresectable metastasis.

Detailed description: Phase I/II clinical trial to analyze safety and efficiency of intralesional application of the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic melanoma stage III/IV and unresectable metastasis. The antibody is directed against epitops of human CD28 and the melanoma associated surface antigen HMV-MAA. Treatment over 5 days with dose escalation.

Eligibility criteria: Inclusion Criteria:

* malignant melanoma stage III/IV
* injectable soft tissue metastasis
* informed consent given
* Karnofsky \>= 70%

Exclusion Criteria:

* additional chemotherapeutical treatment
* systemic glucocorticoids
* brain metestasis
* other malignancies

Primary outcomes:
measure: toxicity
measure: clinical response
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University of Tuebingen, Department of dermatology
Study officials:
affiliation: Department of dermatology, university of tuebingen
name: Garbe Claus, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tuebingen, Dept. of Immunology
name: Gundram Jung, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07003594: Effect of Education Given With Jigsaw IV Learning Technique for Physical Assessment of Heart and Thorax on Knowledge and Skills of Nursing Students
Official title: Effect of Education Given With Jigsaw IV Learning Technique for Physical Assessment of Heart and Thorax on Knowledge and Skills of Nursing Students
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nursing Education Research
Nursing Education
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Title: The Effect of Jigsaw IV Learning Technique on Nursing Students' Knowledge and Skills in Heart and Thorax Assessment Objective: This study aims to evaluate the impact of education using the Jigsaw IV learning technique on the knowledge and skills of nursing students in performing physical assessments of the heart and thorax.

Methodology: A randomized controlled trial will be conducted with 70 second-year nursing students at Baskent University. Participants will be divided into an intervention group (n=35), receiving Jigsaw IV-based education, and a control group (n=35), receiving traditional education. Data collection, scheduled between 22.02.2025 and 22.05.2025, will include a Personal Information Form, Pretest/Posttest for Knowledge Assessment, Skill Assessment Form, and Jigsaw Opinion Scale. Knowledge levels will be analyzed using an independent samples t-test, skill levels using the Mann-Whitney U test, and students' perceptions of the Jigsaw IV method through frequency and percentage analysis.

Expected Outcome:The study will assess whether the Jigsaw IV method enhances students' knowledge and skills in heart and thorax assessment, contributing to the evaluation of its effectiveness in nursing education.


Eligibility criteria: Inclusion Criteria:

* Being a 2nd year nursing student.

Exclusion Criteria:

* not volunteering to participate in the study

Primary outcomes:
measure: Knowledge level for heart and thoracic examination
timeFrame: 2 weeks before the application starts and 2 weeks after training with jigsaw IV
measure: skill performance level for heart and thoracic examination
timeFrame: 2 weeks before the application starts and 2 weeks after training with jigsaw IV
measure: Jigsaw Opinion Scale (JOS)
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
References:
Clinical trial NCT00469794: The Significance of Arrhythmias in Athletes
Official title: The Long Term Significance of Exercise Induced Ventricular Arrhythmias in Trained Athletes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sudden Death
Keywords: arrhythmias
Athletes
exercise
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Institute of Physical Education and Sports Sciences
First posted: 2007-05-07
Enrollment: 300
Sex: ALL
Minimum age (years): 10
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE

Brief summary: Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The aim of the study is to investigate the relevance of ventricular tachyarrhythmias induced by an exercise test in a retrospectively evaluated athletic population.

Detailed description: Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The risk is increased when the athletes are engaged in competitive activities.

Ventricular premature beats (VPB's) are a common finding in the athletic heart. In the majority of cases these arrhythmias are part of the "athlete's heart syndrome" and do not increase the risk of sudden death in the athletes with an apparently normal heart. The data available in the literature deal with ventricular arrhythmias assessed only by 24-h ambulatory electrocardiograms.

To date, there are no guidelines concerning athletes who develop ventricular arrhythmias during a stress test. It is unclear whether they should be allowed to continue with their competitive activity or they should be denied to do so. A study looking at the long term follow-up of these athletes will help us determine whether the development of ventricular arrhythmia during a stress test imposes any risk on the athletes.

Eligibility criteria: Inclusion Criteria:

* Competitive athletes less than 35 YO
* Competitive athletes with ventricular arrhythmias on baseline or recovery in a stress test
* Competitive athletes with ventricular arrhythmia during exercise

Exclusion Criteria:

* Athletes who don't meet the exclusion criteria.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Wingate Institute
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Therese Fuchs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03747094: Sedation of Morbidly Obese for Balloon Insertion
Official title: Fentanyl Versus Ketamine Supplementation for Prpofol Anesthesia During Balloon Insertion in Morbidly Obese Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 70
Sex: ALL
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: This prospective study will assess the value of different supplements to orpofol bases anesthesia in morbidly obes e patients scheduled for balloon insertion. Two common drugs will be added to propofol bases anesthesia;Ketamine or fentanyl. Effect on prpofol consumption, post-procedure recovery profile, and patient satisfaction will be the study objectives.


Eligibility criteria: Inclusion Criteria:

* morbid obese indicated for gastric balloon insertion

Exclusion Criteria:

- Refusal Hypersensitivity to any of the study drugs

Primary outcomes:
measure: Propofol consumption (milligrams)
timeFrame: 24 hours after the endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Al Manşūrah
country: Egypt
facility: Mansoura university
state: Dkahleya
Study officials:
References: