louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03632980: Dynamic Focusing Evaluation for Prostate Cancer Treatment
Official title: Evaluation of a Dynamic Focusing Ultrasonic Transducer for High Intensity Focused Ultrasound (HIFU) Treatment of Localized Prostate Adenocarcinoma - Dose Escalation Trial to Define the Best Acoustic Parameters
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer of Prostate
Keywords: HIFU
Localized Prostate cancer
MRI
PSA nadir
Biopsy
High Intensity Focused Ultrasound
Prostate Specific Antigen (PSA)
Lead sponsor: EDAP TMS S.A.
Sponsor class: INDUSTRY
First posted: 2018-08-16
Enrollment: 180
Sex: MALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Define the best acoustic parameters for the dynamic focusing HIFU transducer in the treatment of localized Prostate Cancer.


Eligibility criteria: Inclusion Criteria for primary care patients:

* Age \> 70 years
* T1 or T2
* PSA \< 15 ng/mL
* 12 randomized biopsies
* Gleason score ≤ 3+4
* Normal anal and rectal anatomy
* American Society of Anesthesiologists risk (ASA) 1 or 2

Exclusion Criteria for primary care patients:

* T3 patients
* American Society of Anesthesiologists risk (ASA) 3
* Metastatic disease (Bone scan...)
* Previous prostate cancer therapy
* Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness
* Prostate volume over 50cc
* Previous bladder cancer
* contraindication to MRI
* previous rectal or urinary fistulae

Inclusion Criteria for salvage patients:

* Age \> 50 years
* T1 or T2
* Biochemical recurrence after radiotherapy (Phoenix definition: nadir+2ng/ml)
* 12 randomized biopsies
* Normal anal and rectal anatomy
* ASA 1 or 2

Exclusion Criteria for salvage patients:

* T3 patients
* ASA 3
* Metastatic disease (Bone scan...)
* Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness
* Prostate volume over 50cc
* Previous bladder cancer
* contraindication to MRI
* previous rectal or urinary fistulae

Primary outcomes:
measure: Necrosis measurement (immediate efficacy)
timeFrame: Day 7
Secondary outcomes:
measure: Histological marker measurement (mid term efficacy)
timeFrame: 6 months
measure: Biochemical marker measurement (mid term efficacy)
timeFrame: 6 months
measure: Rectal wall preservation (immediate safety and morbidity)
timeFrame: Day 7
measure: Adverse events reporting rates (safety and the morbidity) at 6 months
timeFrame: 6 months
measure: Adverse events reporting rates (safety and the morbidity) at 24 months
timeFrame: 24 months
measure: Quality of life score
timeFrame: 3 months
measure: Quality of life score
timeFrame: 6 months
measure: IPSS score
timeFrame: 3 months
measure: IPSS score
timeFrame: 6 months
measure: IIEF-5 score
timeFrame: 3 months
measure: IIEF-5 score
timeFrame: 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Edouard Herriot Hospital
Study officials:
affiliation: Edouard Herriot Hospital, Lyon, France
name: Albert GELET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02370680: Length of Effect of Extended Release Aspirin on Platelets in Patients With Diabetes and Heart Disease
Official title: Durability of Antiplatelet Effect of a Novel Extended-Release Formulation of Acetylsalicylic Acid, Durlaza in CVD (Cardiovascular Disease) Patients at Risk of High Platelet Turnover
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Disease
Keywords: Antiplatelet
Antiplatelet therapy
platelet turnover
high platelet turnover
platelet aggregation
cardiovascular disease
coronary artery disease
diabetes mellitus
Lead sponsor: New Haven Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being conducted to evaluate the safety and the length of effect on platelet build-up in the arteries of Durlaza™ as compared to immediate-release Bayer® aspirin 81 mg or subject's current aspirin 81 mg of choice in patients who have Type 2 diabetes mellitus and cardiovascular disease or multiple risk factors of developing cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* Male or non-lactating, non-pregnant female subjects
* A history of Type 2 Diabetes and with history of at least one of the following: Coronary Artery Disease, Peripheral Vascular Disease, or Ischemic Stroke, along with at least 2 CVD risk factors (obese, smoker, ≥ 55 years of age, prior thrombotic event)

Exclusion Criteria:

* Sensitivity to aspirin or any NSAID (nonsteroidal antiinflammatory drug),
* Evidence of uncontrolled or unstable cardio- or cerebrovascular disorder,
* Presence of uncontrolled or chronic medical illness, GI disorder or surgery leading to impaired drug absorption, clinically significant abnormal baseline ECG, history of hepatitis, malignancy within the past five years, or HIV, history of alcohol or drug abuse.

Primary outcomes:
measure: change in platelet aggregation
timeFrame: During the 26-hour hospital stays, outcomes will be measured at various timepoints
Secondary outcomes:
measure: Reactive Hyperemia Index
timeFrame: During the 26-hour hospital stays, outcomes will be measured at various timepoints
measure: Safety as measured by the number and system class of adverse events reported in each treatment arm
timeFrame: participants are followed for approximately 40 to 65 days once they start study medication
Other outcomes:
measure: Serum Thromboxane
timeFrame: During the 26-hour hospital stays, outcomes will be measured at various timepoints
measure: urinary metabolites of prostacyclin and thromboxane
timeFrame: During the 26-hour hospital stays, outcomes will be measured at various timepoints
Locations:
city: Baltimore
country: United States
facility: Platelet and Thrombosis Research, LLC
state: Maryland
Study officials:
affiliation: Platelet Thrombosis Research, LLC
name: Paul Gurbel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06204380: An Observational Study on the Identification of Prescription Patterns of STAFEN Cap
Official title: An Observational Study on the Identification of Prescription Patterns of STAFEN Cap., Changes in Blood Lipid Concentration, and Statin-related Muscle Symptoms in Korean Patients With Mixed Dyslipidemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mixed Dyslipidemia
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-12
Enrollment: 4000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients Prescribed STAFEN Cap. for the Treatment of Mixed Dyslipidemia

Brief summary: An observational study on the identification of prescription patterns of STAFEN Cap., changes in blood lipid concentration, and statin-related muscle symptoms in Korean patients with mixed dyslipidemia

Detailed description: This study aims to observe the effectiveness of STAFEN capsule such as changes in blood lipid concentration and safety including statin-related muscle symptoms, and prescription patterns under daily clinical treatment in patients who have been prescribed STAFEN capsules for the treatment of complex dyslipidemia.

Eligibility criteria: Inclusion Criteria:

1. Adults over 19 years of age
2. A patient diagnosed with mixed dyslipidemia
3. A patient who was first prescribed a STAFEN cap. for the purpose of treating mixed dyslipidemia according to the clinician's judgment
4. A patient who voluntarily agreed in writing to this study

Exclusion Criteria:

1. Pregnant women, lactating women, or those planning to conceive
2. A person who is prohibited from administering the STAFEN cap. under the permit
3. If the person in charge of other clinical studies and the person in charge deems it inappropriate to be the subject of this clinical study

Primary outcomes:
measure: Target triglyceride rate at 6 months of STAFEN capsule prescription compared to baseline
timeFrame: at 6 months of STAFEN capsule prescription compared to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gangneung-si
country: Korea, Republic of
facility: Delphoe Clinic
Study officials:
affiliation: delphoe clinic
name: Heebaek Park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03340480: The Food Effect on the Pharmacokinetics of NVP-1402
Official title: The Food Effect on the Pharmacokinetics of NVP-1402
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2017-11-13
Enrollment: 32
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The purpose of this study is to evaluate the food effect on the pharmacokinetics of NVP-1402 in healthy male volunteers.

Detailed description: This study is designed as randomized, open-label, single oral dose, two-treatment, two sequence crossover active-controlled and crossover assignment for evaluate the food effect on the pharmacokinetics of NVP-1402 in healthy male subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy males
* No history of clinically significant medical disorder
* Capable of consent to participate in the study

Exclusion Criteria:

* History of hypersensitive reactions to study drug or other related drugs
* Any significant abnormality found during screening
* Any significant medical history
* History of alcohol abuse, smoking continuously
* History of drug abuse
* Clinically significant surgery within 4 weeks prior to administration of the study drug
* Participation in another clinical trial within 3 months prior to administration of the study drug

Primary outcomes:
measure: Pharmacokinetics of plasma: Cmax
timeFrame: up to 24 hours after administration
measure: Pharmacokinetics of plasma: AUClast
timeFrame: up to 24 hours after administration
Secondary outcomes:
measure: Pharmacokinetics of plasma: AUCinf
timeFrame: up to 24 hours after administration
measure: Pharmacokinetics of plasma: Tmax
timeFrame: up to 24 hours after administration
measure: Pharmacokinetics of plasma: t1/2
timeFrame: up to 24 hours after administration
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: Navipharm
state: Gyeonggi-do
Study officials:
affiliation: Gachon University Gil Medical Center
name: D Seong Shin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00405080: A Study in Healthy Subjects to Assess How Dosing of Rifampin Affects What the Body Does to a Dose of GW679769 (Casopitant).
Official title: An Open-Label, Two Period, Fixed Sequence Study of Healthy Subjects to Assess the Effect of Repeat Oral Dosing of [Rifampin] on the Pharmacokinetics of a Single Oral Dose of [GW679769]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nausea and Vomiting, Chemotherapy-Induced
Keywords: Rifampin GW679769
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine what the body does while taking GW679769 alone and together with rifampin in healthy adult subjects.


Eligibility criteria: Inclusion criteria:

* healthy
* female subjects who cannot become pregnant
* able to swallow and keep down oral medication
* can understand and follow the protocol requirements and instructions

Exclusion criteria:

* smokes at least 4 packs per day in the past 12 months
* use of prescription or non-prescription drug(s)
* herbal or dietary supplements or vitamins with 14 days prior to first dose of study medication
* a clinically relevant abnormality medical condition or circumstance making the subject unsuitable for the study per the study doctor
* blood donation in excess of 1 pint within 56 days before dosing of medication
* iron deficient
* history or drug allergy of study medication
* history of drug or alcohol abuse or dependency within the past 6 months
* subjects cannot use any nicotine-containing products within the last 6 months
* positive for HIV, Hepatitis B or C
* active peptic ulcer disease
* uncontrolled nausea and vomiting
* active infection
* heart failure
* female who is lactating
* female who has a positive pregnancy test

Primary outcomes:
measure: Plasma levels for casopitant will be measured in Period 1 at Day 1 to 3 and in Period 2 at Day 8. Plasma levels for rifampin will be measured in Period 2 at Day 8 to 10.
timeFrame: Up to Day 10
Secondary outcomes:
measure: clinical lab tests adverse events vital signs 12 lead ECGs liver function tests
timeFrame: Up to Day 12
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04809480: COVID-19 and Acute Invasive Fungal Rhinosinusitis
Official title: The Impact of COVID-19 Outbreak on The Incidence of Acute Invasive Fungal Rhinosinusitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: fungal sinusitis
rhinosinusitis
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 56
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of any age and sex medically managed in AlAzhar Hospitals in Egypt for invasive rhinosinusoitis

Brief summary: Data for acute invasive rhinosinusitis was obtained from the Otorhinolaryngology departments at our tertiary hospital at the period from January 2017 to December 2020. Then the risk factors of comorbid diseases and fungal types between post-Covid-19 and non-Covid-19 groups regarding the incidence of invasive rhinosinusitis are compared.


Eligibility criteria: Inclusion Criteria:

* Patients of any age and sex. invasive rhinosinusoitis diagnosis based on clinical , endoscopic diagnosis
* Positive findings for acute sinusitis on sinus computed tomography (CT) scan in addition to fungal determination by histopathological examination of specimen of affected tissues for detection of the type of fungi.
* Positive PCR was confirmed from the patient's files at the isolation hospitals for COVID 19 group.

Exclusion Criteria:

* Patients who completed management outside our hospital

Primary outcomes:
measure: Fungus detection
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05742880: Effect of Face Masks on Pulmonary Function in Patients With COPD
Official title: Effect of Face Masks on Pulmonary Function in Patients With COPD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Walking, Difficulty
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Given the heightened vulnerability of COPD patients to severe illness upon SARS-CoV-2 infection, precautions like mask-wearing are deemed crucial. Yet, mask-wearing can exacerbate breathlessness and discomfort in this demographic. This study aims to assess the effects of wearing a face mask during 6-Minute-Walking-Tests (6-MWT) among COPD patients.

Detailed description: In this detailed study, we aim to explore the impact of wearing face masks on COPD patients during 6-Minute-Walking-Tests (6MWT). COPD, commonly observed among smokers and former smokers, poses heightened mortality risks upon SARS-CoV-2 infection. Consequently, face masks are often recommended for preventive measures. However, breathlessness remains a predominant symptom in this patient cohort. Moreover, there is a dearth of data concerning blood oxygenation levels while wearing various types of face masks.

The study will involve COPD patients who will undergo three 6MWTs: one without a mask, one with a simple face mask, and one with a FFP2 mask. Prior to each 6MWT, comprehensive pulmonary function tests including spirometry, body plethysmography, and CO-diffusion capacity measurement will be conducted. Additionally, capillary blood gas analysis will be performed both before the 6MWT and after each test session.

Eligibility criteria: Inclusion Criteria:

* COPD Diagnosis
* Vaccinated against SARS-CoV 2

Exclusion Criteria:

* Known cardial insufficency
* Long term oxgenation therapy
* immobility
* BMI \>35
* Pregnancy

Primary outcomes:
measure: Walking distance
timeFrame: 6 minutes
Secondary outcomes:
measure: Blood oxygenation
timeFrame: 6 minutes
measure: Heart rate
timeFrame: 6 minutes
measure: pO2
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Dept. of Internal Medicine II, Div. of Pulmonology
Study officials:
affiliation: Medical University of Vienna
name: Marco Idzko, Prof.
role: STUDY_CHAIR
affiliation: Medical University of Vienna
name: Lukasz Antoniewicz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06911762: The Effects of a Structured Hand Exercise Program on Trigger Finger: A Randomized Controlled Trial
Official title: The Effects of a Structured Hand Exercise Program on Trigger Finger: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trigger Finger
Keywords: Trigger finger
tenosynovitis
physiotherapy
conservative treatment
Exercise
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the effectiveness of a structured hand exercise program as a conservative treatment for trigger finger.


Eligibility criteria: Inclusion Criteria:

* Adults with aged \> 18 years old who are diagnosed with trigger finger
* The Green classification grade 2 or grade 3
* Pain (NPRS) equal or more than 4/10, during active triggering

Exclusion Criteria:

* Pediatric or congenital trigger finger
* Previously received physiotherapy, corticosteroid injection or surgery for trigger finger
* Hand trauma, local infection or using systemic steroids due to other diseases

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS) during triggering or movement
timeFrame: Baseline, 6 weeks after baseline, 10 weeks after baseline
Secondary outcomes:
measure: Trigger finger stage in the Green Classification
timeFrame: Baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Frequency of triggering
timeFrame: Baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Functional score by Quick Disabilities of the Arm, Shoulder, and Hand Questionnaire (Hong Kong version)
timeFrame: Baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Grip strength of the affected hand
timeFrame: Baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Structural changes using musculoskeletal ultrasound (A1 pulley thickness, flexor tendon thicknesses, A1 pulley lumen size)
timeFrame: Baseline, 6 weeks after baseline, 10 weeks after baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References:
Clinical trial NCT03926962: The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers
Official title: Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
First posted: 2019-04-25
Enrollment: 67
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: OTHER

Brief summary: This is a double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part and a 2-way crossover food effect (FE) part. Each subject will participate in only one cohort during the study.


Eligibility criteria: Inclusion Criteria:

* BMI : 18-30 kg/m2 (Body Mass Index \[BMI\] \[kg/m2\] = Body weight \[kg\] Height2 \[m2\])
* Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks"), grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge
* Medical history without major pathology

Exclusion Criteria:

* Evidence of clinically relevant pathology
* Mental handicap
* History of relevant drug and/or food allergies
* Regular/routine treatment with non-topical medications within 30 days prior to entry into the clinical research center
* Smoking within 60 days prior to drug administration and through the follow-up visit
* History of alcohol abuse or drug addiction (including soft drugs like cannabis products)

Primary outcomes:
measure: Assessing incidence of treatment emergent AEs
timeFrame: Day 18
measure: Evaluating PK parameters for profiling
timeFrame: Day 4
measure: Evaluating PK parameters for profiling
timeFrame: Day 4
measure: Evaluating PK parameters for profiling
timeFrame: Day 4
measure: Evaluating PK parameters for profiling
timeFrame: Day 4
measure: Evaluating PK parameters for profiling
timeFrame: Day 4
measure: Evaluating PK parameters for profiling
timeFrame: Day 4
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: