louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04755894: HDDO-1756 Bio Equivalence Study
Official title: A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination of HDDO-1756 or Loose Combination of HDDO-17561/HDDO-17562 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperlipidemias
Lead sponsor: Hyundai Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2021-02-16
Enrollment: 56
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: For healthy adult volunteers, safety and pharmacokinetic properties are compared between the two formulations in the case of HDDO-1756 alone administration and HDDO-17561/HDDO-17562 combined administration.


Eligibility criteria: Inclusion Criteria:

1. Healthy adult volunteers aged 19 or older during screening
2. A person who weighs more than 50.0 kg and has a BMI of 18.0 kg/m2 or less and 30.0 kg/m2 or less.

   ☞ BMI (kg/m2) = Weight (kg) / {Long (m)}2
3. A person who has no chronic disease or medical treatment and has no pathological symptoms or findings as a result of an internal examination;
4. A person who has been determined to be eligible for a clinical trial according to the characteristics of the drug during screening, such as serum tests, hematologic tests, hematological tests, urine tests, urine tests, etc. and vital signs (physical tests) and 12-lead ECG tests.

Exclusion Criteria:

1. Current or past history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, urinary system, cardiovascular system, digestive system, musculoskeletal disease, or mental illness, as well as those with the following symptoms or history:
2. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
3. Persons with a history of gastrointestinal diseases (cron disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of drugs;

Primary outcomes:
measure: pharmacokinetic evaluation variables
timeFrame: 0~96 hours
measure: pharmacokinetic evaluation variables
timeFrame: 0~96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hyundai Pharm
Study officials:
References:
Clinical trial NCT04891094: Lung and Diaphragm Ultrasound in the Early Postoperative Course Following Lung Transplantation
Official title: Lung and Diaphragm Ultrasound in the Early Postoperative Course Following Lung Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplantation
Keywords: Lung ultrasound
Lung transplantation
primary graft dysfunction
Lung Sliding
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This feasibility study tries to define the value of daily Lung and Diaphragm Ultrasound in the early postoperative course following Lung transplantation by comparing its diagnostic accuracy with that of standard of care diagnostic procedures

Detailed description: Lung transplantation remains a high risk procedure. Common complications in the early postoperative course are, among others, primary graft dysfunction (PGD), hemorrhage, anastomosis insufficiency leading to pneumothorax, pneumonia, atelectasis and diaphragm dysfunction. Early diagnosis of complications is important to avoid further deterioration. Lung ultrasound (LUS) and diaphragm ultrasound (DUS) has a high diagnostic accuracy for identifying frequent conditions in the critically ill. Studies evaluating its value in patients following lung transplantation are missing. This study investigates the feasibility and clinical ability of LUS and DUS to identify common complications following lung transplantation and compares it to standard of care diagnostic procedures. The investigators start a prospective cohort study of lung transplant recipients who undergo lung transplantation at the university hospital Munich. Daily LUS and DUS in the early postoperative phase will be performed to detect and monitor complications. The US results will be compared to the results of diagnostic procedures of the clinical routine such as clinical examination, chest x ray, hemodynamic monitoring, expert opinion on PGD and laboratory parameters.

The hypothesis is that daily LUS and DUS following lung transplantation helps to diagnose complications early and with higher accuracy compared to the results of diagnostic procedures of the clinical routine.

Eligibility criteria: Inclusion Criteria:

* informed consent
* patient following lung transplantation

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: The value of LUS in diagnosing PGD
timeFrame: postoperative day 3
measure: Is Lung Sliding reliable in the early postoperative course following lung transplantation?
timeFrame: postoperative day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Anaesthesiology of the University Hospital of Munich
Study officials:
References:
Clinical trial NCT01724294: An Observational Study of MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in First-Line in Patients With Diffuse Large B-Cell Lymphoma
Official title: Non-interventional, Post-marketing Study to Evaluate the Correlation Between Clinical and Biological Factors and IPI as Prognostic Factors in Patients With DLBCL in First Line Treatment With R-CHOP
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diffuse Large B-Cell Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-11-09
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diffuse large B-cell lymphoma treated in first line with R-CHOP

Brief summary: This multicenter, observational study will evaluate the correlation between clinical and biological factors and International Prognostic Index (IPI) as prognostic factors in patients with diffuse large B-cell lymphoma receiving first-line treatment with MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy. Eligible patients receiving treatment according to standard of care and local guidelines will be followed for the duration of treatment (approximately 8 months) and during 1 year of follow-up.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>18 years of age
* Patients with diagnosed diffuse large B-cell lymphoma in first-line treatment with R-CHOP

Exclusion Criteria:

* Prior chemotherapy treatment for diffuse large B-cell lymphoma
* Contra-indications or exclusion criteria according to the Summary of Product Characteristics for MabThera/Rituxan

Primary outcomes:
measure: Treatment patterns in clinical practice: Number of treatment cycles received
timeFrame: approximately 4 years
Secondary outcomes:
measure: Event-free survival
timeFrame: approximately 4 years
measure: Response rates
timeFrame: approximately 4 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 4 years
Other outcomes:
Locations:
city: Bucuresti
country: Romania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06282094: ViSiGi LUX Bariatric Sizing and Calibration System
Official title: ViSiGi LUX Bariatric Sizing and Calibration System Usability Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery Candidate
Lead sponsor: Boehringer Labs LLC
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing gastric or bariatric procedures.

Brief summary: This study investigates the new ViSiGi LUX.

Detailed description: ViSiGi is used during numerous gastric and bariatric procedures. The new device, ViSiGi LUX functions as the FDA-cleared ViSiGi but has the added visualization of NIR lights.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* able to consent
* candidate for robotic bariatric surgery

Exclusion Criteria:

* esophageal stricture that does not allow passage of the device
* conditions that would preclude gastric or bariatric surgical procedures
* pregnant patients

Primary outcomes:
measure: Physician Feedback
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: York
country: United States
facility: WellSpan
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05347394: A Phase 1 Dose Escalation Study of Oral VX-708 in Healthy Participants
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Oral VX-708 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2022-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of VX-708 in healthy participants.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Male and female of non-childbearing potential are eligible
* Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m\^2)
* A total body weight greater than (\>) 50 kg

Key Exclusion Criteria:

* History of febrile illness or other acute illness within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
* History of cardiac dysrhythmias

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Parts A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 25
measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
timeFrame: From Day 1 up to Day 25
Secondary outcomes:
measure: Parts A and B: Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-708
timeFrame: From Day 1 up to Day 25
measure: Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test
timeFrame: From Day 1 up to Day 11
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: MAC Clinical Research
Study officials:
References:
Clinical trial NCT06874894: Thromboembolic And Bleeding Risks During anticoaGulant trEatment in Asian paTients With Atrial Fibrillation (TARGET-AF)
Official title: Thromboembolic and Bleeding Risk During Anticoagulant Treatment in Asian Patents With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Fibrillation, Atrial
Keywords: Atrial Fibrillation
Stroke
Bleeding
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
Collaborators: name: Chung-Ang University Gwangmyeong Hospital
name: Samsung Medical Center
name: Korea University Ansan Hospital
name: Kosin University Gospel Hospital
name: Keimyung University Dongsan Medical Center
name: Yuhan Corporation
First posted: 2025-03-13
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AF patients with NOAC

Brief summary: This study was design to investigate the efficacy and safety of NOAC therapy in Koreans

Detailed description: East Asians have demonstrated a higher bleeding tendency compared to Western populations during an anticoagulation. Consequently, East Asians have been prescribed as a relatively weaker treatment regimens based on this evidence. Therefore, the TARGET-AF study aims to verify the efficacy and safety of NOAC therapy in Koreans

Eligibility criteria: Inclusion Criteria:

* Patients with documented AF on 12-lead ECG, Holter monitoring, or single-lead ECG recordings are eligible for enrollment.
* Based on AF treatment Korean guideline 19, AF patients who require NOAC treatment or are currently on NOAC treatment (within the past 3 months)
* Adults aged 18 or above who have provided consent for clinical information

Exclusion Criteria:

* Patients with moderate or severe mitral stenosis or mechanical prosthetic valve

Primary outcomes:
measure: Clinical ischemic and hemorrhagic events
timeFrame: 12 months
Secondary outcomes:
measure: Clinical other events
timeFrame: 12 months
Other outcomes:
measure: COVID-19 infection
timeFrame: 12 months
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
References:
citation: Lee SH, Kim HK, Ahn JH, Kang MG, Kim KH, Bae JS, Cho SY, Koh JS, Park Y, Hwang SJ, Gorog DA, Tantry US, Bliden KP, Gurbel PA, Hwang JY, Jeong YH. Prognostic impact of hypercoagulability and impaired fibrinolysis in acute myocardial infarction. Eur Heart J. 2023 May 14;44(19):1718-1728. doi: 10.1093/eurheartj/ehad088.
Clinical trial NCT00035594: Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy
Official title: A Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Evaluating the Prophylactic Use of Pegfilgrastim on the Incidence of Febrile Neutropenia in Subjects With Advanced Breast Cancer Treated With Single Agent Docetaxel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neutropenia
Keywords: Breast cancer
Neutropenia
Chemotherapy
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2002-05-06
Enrollment: 928
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Physicians are conducting a clinical trial for patients with advanced breast cancer. Breast cancer can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in patients with advanced breast cancer.


Eligibility criteria: * Advanced breast cancer
* 18 years of age or older
* Patients who will be receiving Taxotere (docetaxel) chemotherapy

Primary outcomes:
measure: Proportion of subjects developing febrile neutropenia
timeFrame: Through 4 cycles
Secondary outcomes:
measure: Incidence of hospitalization and IV antiinfective use associated with FN; also chemotherapy planned dose on time
timeFrame: Through 4 cycles
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Vogel CL, Wojtukiewicz MZ, Carroll RR, Tjulandin SA, Barajas-Figueroa LJ, Wiens BL, Neumann TA, Schwartzberg LS. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol. 2005 Feb 20;23(6):1178-84. doi: 10.1200/JCO.2005.09.102.
citation: Lyman GH, Reiner M, Morrow PK, Crawford J. The effect of filgrastim or pegfilgrastim on survival outcomes of patients with cancer receiving myelosuppressive chemotherapy. Ann Oncol. 2015 Jul;26(7):1452-8. doi: 10.1093/annonc/mdv174. Epub 2015 Apr 7.
Clinical trial NCT06748794: Effects of Intrathecal Midazolam (1mg) With Hyperbaric Bupivacaine 0.5% (15mg) for Spinal Anesthesia for C-section
Official title: Effects of Intrathecal Midazolam (1mg) With Hyperbaric Bupivacaine 0.5% (15mg) for Spinal Anesthesia for Caesarean Section
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cesarean Section Complications
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: to check the Effects of Intrathecal Midazolam (1mg) With Hyperbaric Bupivacaine 0.5% (15mg) for Spinal Anesthesia for Caesarean Section

Brief summary: This study evaluates the effects of intrathecal midazolam (1 mg) combined with hyperbaric bupivacaine 0.5% (15 mg) for spinal anesthesia in cesarean section patients.

Detailed description: The addition of midazolam, a benzodiazepine with analgesic and anxiolytic properties to bupivacaine is hypothesized to enhance the quality of anesthesia and postoperative pain relief without significant side effects. A comparative analysis was conducted to assess sensory and motor block characteristics, postoperative analgesia duration, maternal hemodynamic stability, and neonatal outcomes.

Eligibility criteria: Inclusion Criteria:

* Female patients presented for elective cesarean section.
* All ASA I \& II patients .
* Age between 18 to 35 years.

Exclusion Criteria:

* Contraindication to spinal anesthesia.
* Patient not willing or previous bad experience with it.
* All ASA III \& IV class was excluded from the study.
* Patients with documented bleeding disorders i.e. low platelet count, deranged PT/APTT/INR, DIC etc.
* Hypertensive patients
* Patients with Diabetes mellitus.
* Obese patients BMI \>30.
* PIH (pre- eclampsia and eclapmsia)"

Primary outcomes:
measure: Duration of postoperative analgesia
timeFrame: 12 Months
measure: Quality of sensory and motor block
timeFrame: 12 Months
measure: Hemodynamic stability
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nowshera
country: Pakistan
facility: Nowshera
state: Khyber Pakhtunkhwa
Study officials:
References:
Clinical trial NCT00528294: Phase I Trial From GRID 18F-FDG-PET Biological Imaging-guided Intensitymodulated Radiotherapy (BG-IMRT) With Patients With Recurrent or New Head or Neck Tumor in Previously Radiated Area
Official title: Phase I Trial From GRID 18F-FDG-PET Biological Imaging-guided Intensitymodulated Radiotherapy (BG-IMRT) With Patients With Recurrent or New Head or Neck Tumor in Previously Radiated Area
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Head and Neck Tumors
Keywords: Recurrent head and neck tumors
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2007-09-12
Enrollment: 12
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 trials examines the feasibility of GRID-therapy combined with biologically imaging based IMRT (BG-IMRT). Within this trial, the strict toxicity parameters of primary treatment of head and neck tumors are used. The GRID and BG-IMRT technique might be possible to reduce the total radiation dose 2 to 3 times.


Eligibility criteria: Inclusion Criteria:

* Recurrent or new head or neck tumor
* 18 years or older

Primary outcomes:
measure: Maximum tolerated dose.
timeFrame: 3 months after end of treatment
measure: Superior local control with Grid 18F-FDG-PET BG-IMRT using previously obtained maximum tolerated dose.
timeFrame: 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Wilfried De Neve, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02142894: Evaluation of the QuantiFERON-TB Test.
Official title: Evaluation of the 4th Generation QuantiFERON-TB Test (CST001) for the Detection of Tuberculosis Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: Tuberculosis
TB
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
First posted: 2014-05-20
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bacteriologically confirmed and untreated TB disease.

Brief summary: To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.

Detailed description: The objective of the study was to enroll patients who have clinical signs/symptoms strongly indicating TB and who are receiving of have to start the treatment for active TB, and test the variants of the CST001 assay to support the evaluation of clinical sensitivity.

Eligibility criteria: Inclusion Criteria:

* Clinical symptoms consistent with a high probability of having TB disease
* Receiving, or are likely to receive, therapy for active TB
* Confirmed tuberculosis by either AFB smear and culture testing, or Nucleic Acid Amplification methods and culture testing.
* Between 18 and 70 years of age.

Exclusion Criteria:

* Taken therapy for active TB or latent TB for more than 14 days
* Culture confirmation of M. tuberculosis not obtained

Primary outcomes:
measure: Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity
timeFrame: At time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Brenda Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc.