louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01968707: In-vivo Efficacy Study of Patient Pre-operative Preps
Official title: Assessment of the Antimicrobial Efficacy of 3M CHG/IPA Preoperative Skin Preparation Against Resident Human Skin Flora on the Abdominal and Inguinal Regions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Reduction on Skin Flora Post-product Application
Keywords: surgical prep
CHG
IPA
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2013-10-24
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

Detailed description: The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70%.

On the abdominal sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

On the inguinal sites, a responder is defined as a subject with a 3-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

Eligibility criteria: Inclusion Criteria:

* Subjects of any race
* Subjects in good general health
* Minimum skin flora baseline requirements on abdomen and groin

Exclusion Criteria:

* Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test areas
* Topical antimicrobial exposure within 14 days prior to screening and treatment days
* Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days

Primary outcomes:
measure: Responder Rate
timeFrame: baseline, 10 minutes post-product application and 6 hour post-product application
Secondary outcomes:
measure: Reduction of Skin Flora 6 Hours Post-treatment
timeFrame: 6 hours
measure: Reduction of Skin Flora 10 Minutes Post-treatment
timeFrame: 10 minutes
measure: Skin Flora Recovery 6-hours Post-treatment
timeFrame: 6 hours post-treatment
measure: Skin Flora Recovery 10 Minutes Post-treatment
timeFrame: 10 minutes post-treatment
measure: Skin Flora Baseline for the Abdominal and Inguinal Region.
timeFrame: Baseline
measure: Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
timeFrame: Assessed at baseline (pre-treatment) and 10 minute post-treatment and 6 hour post-treatment.
Other outcomes:
Locations:
city: Sterling
country: United States
facility: Microbiotest
state: Virginia
Study officials:
affiliation: MICROBIOTEST
name: Muhammad H Bashir, MD, CCRP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06614907: A PhaseⅠ Comparative Study to Evaluate the Pharmacokinetics of QL2108 to Dupixent®
Official title: A Randomized, Double-blinded, Parallel, Single-dose, PhaseⅠComparative Study to Evaluate the Pharmacokinetics and Safety of QL2108 to Dupixent® in Healthy Chinese Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-26
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a randomized, double-blinded, parallel, single-dose, PhaseⅠcomparative study to evaluate the pharmacokinetics and safety of QL2108 to Dupixent® in healthy Chinese adult subjects. A total of 198 healthy subjects are planned to be included and randomized at a ratio of 1:1 to receive single 300mg/2.0ml QL2108 injection or Dupixent®.

Detailed description: The study has a screening period of 28 days. PK blood samples will be collected from subjects to determine the serum concentration of Dupilumab, thus to evaluate the similarity of the pharmacokinetics of the two study drugs.

The investigator will perform safety evaluation for vital signs, physical examinations, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.

Eligibility criteria: Inclusion Criteria:

* Chinese healthy subjects aged from 18 to 50 years (including the boundary value)
* Normal vital signs, physical examinations, ECG, clinical laboratory tests and imageological examination results or abnormal with no clinical significance according to the doctor's judgment;
* Body weight between 50-90kg and BMI between 19.0-26.0kg/m2 (including boundary value);

Exclusion Criteria:

* People who have previously used or participated in clinical trials of monoclonal antibody with the same target or dupilumab
* People with a clear history of allergy and/or allergy to monoclonal antibodies of the same target /investigational drugs and their components.
* People who have special dietary requirements or are unable to follow a uniform diet.
* Dizzy blood, dizzy needle history. Blood donation \> 400 ml within 3 months or \> 200 ml within 4 weeks prior to screening, or planning to donate blood during the study.
* Having participated in drug or device clinical trials within 3 months or 5 half-lives of other investigational drugs before the study administration.

Primary outcomes:
measure: Pharmacokinetics Endpoint
timeFrame: 0-8weeks
measure: Pharmacokinetics Endpoint
timeFrame: 0-8weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
Study officials:
affiliation: Jinan Central Hospital
name: Qing Wen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01089907: Genomic Changes in Childhood Acute Lymphoblastic Leukemia
Official title: Genomics Evolution in Childhood Acute Lymphoblastic Leukemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lymphoblastic Leukemia
Keywords: genomic
childhood
acute lymphoblastic leukemia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-03-19
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute lymphoblastic leukemia patients under 18 years of age

Brief summary: To study the genomics with cell cycle and lymphocyte differentiation in disease, remission and relapse of childhood acute lymphoblastic leukemia. Then correlate these data with age, white cell count, cytogenetic changes, response to the chemotherapy and prognosis.

Detailed description: In order to know the genomic evolution of childhood acute lymphoblastic leukemia, we will collect bone marrow (10c.c.) at diagnosis, remission and relapse. We will do the following genes in addition to gene-chip including IKZF1,ETV6, EBF1, NR3C1, RAG1/G2, TCF3, BTLA, PAX5,LEF1, ERG and VPREB1.We will study the gene dosages and degree of methylation. The estimated patients numbers will be 300-400. Then we will correlate these data with patients'age, white blood cell count at diagnosis, cytogenetic abnormalities, response to the chemotherapy and prognosis.

Eligibility criteria: Inclusion Criteria:

1. patients diagnosed as acute lymphoblastic leukemia
2. age less than or equal to 18 years old
3. signed informed consent

Exclusion Criteria:

1. who is not acute lymphoblastic leukemia
2. who did not sign informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital,Taipei,Taiwan
name: Dong-Tsamn Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04623307: Non-contact DCS-Speckle Multi-parameter Imaging for Neurological Diseases
Official title: Clinical Applications for Non-contact DCS-Speckle Multi-parameter Imaging for Brain Injuries and Brain Edema
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injuries
Brain Edema
Optical Imaging
Keywords: DCS-Speckle
Brain injuries
Brain edema
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Beijing Geriatric Hospital
name: Tianjin Huanhu Hospital
First posted: 2020-11-10
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult individuals and infants of any gender. Brain damage patients were hired in Beijing Geriatric Hospital, and brain edema patients hired in Tianjin Huanhu Hospital.

Brief summary: This study aims to evaluate brain injuries and brain edema with non-contact DCS-Speckle multi-parameter imager.

Detailed description: Brain injuries includes acute and chronic injuries located in cerebral hemispheres, cerebellum, and brain stem, while brain edema is increased intracellular or extracellular fluid in brain tissue. Early diagnosis is helpful to improve the cure rate and reduce sequelae. This study aims to evaluate brain injuries and brain edema with non-contact DCS-Speckle multi-parameter imager, so as to provide reference diagnostic criteria by image artificial intelligence analysis.

Eligibility criteria: Inclusion Criteria:

* Patients who have had brain damage.
* Patients who have had brain edema.
* Healthy people who are interested in non-contact DCS-Speckle multi-parameter imaging

Exclusion Criteria:

* Patients who are in pregnancy or have plan to conception.
* Patients who have vertebra surgery or have plan to surgery.
* Patients who are inappropriate to join this trial judged by the radiologists or specialists.
* AIDS, Active Hepatitis, Tuberculosis, Syphilis
* Patients who regularly take anticoagulants, antiplatelet drugs

Primary outcomes:
measure: Imaging data
timeFrame: 1 day during the whole experiment
Secondary outcomes:
measure: Diagnostic report fMRI data
timeFrame: 1 day during the whole experiment
Other outcomes:
Locations:
city: Tianjin
country: China
facility: NIRS assessment for brain death
state: Tianjin
Study officials:
References:
Clinical trial NCT01495507: Validation of Kujala German
Official title: Cross-cultural Adaptation and Validation of the German Version of the Kujala Score in Patients With Patellofemoral Instability - a Prospective Multi-centric Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Validation of Kujala Score German Version in Patients With Patellofemoral Instability and Scheduled MPFL-reconstruction
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2011-12-20
Enrollment: 45
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with patellofemoral instability \& scheduled MPFL-reconstruction

Brief summary: The field of patellofemoral disorders and accordant therapeutical interventions is a high turnover research field. It is important to verify the clinical outcome with appropriate measuring tools. There is evidence that the Kujala score is a reliable and widely used measuring instrument of patellofemoral disorders. Indeed, the Kujala score was already used in many studies investigating patellofemoral disorders - also in german speaking patient groups. Unfortunately, we are not aware of a validated german version of the Kujala score. Other relevant knee outcome scores were already successfully translated into german language and validated by previous investigators.

So, it is the aim of our study to cross-culturally adapt and then to validate the Kujala score for use in German-speaking individuals with patellofemoral instability. It is hypothesized that the german version of the Kujala score shows:

* High divergent construct validity as determined by significant differences between patients and controls (hypothesis 1)
* High convergent construct validity as determined by significant correlations with other relevant scoring systems (hypothesis 2)
* High reliability (hypothesis 3)
* High responsiveness (hypothesis 4)


Eligibility criteria: Inclusion Criteria:

* german speaking
* MPFL-reconstruction planed

Exclusion Criteria:

Primary outcomes:
measure: Kujala Score
timeFrame: 1 year
measure: KOOS (Knee Injury and Osteoarthritis Outcome Score)
timeFrame: 1 year
measure: Marx Activity Scale
timeFrame: 1 year
measure: SF-12 (Short - Form 12)
timeFrame: 1 year
measure: VAS pain
timeFrame: 1 year
measure: Lysholm Score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Dept. Orthop. Surgery, Medical Univ. Innsbruck
state: Tyrol
Study officials:
References:
Clinical trial NCT06696807: Immunomodulatory Therapy & VSA
Official title: The Effects of Immunomodulatory Therapy in Patients with Vasospastic Angina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vasospastic Angina
Keywords: Immunomodulatory therapy
vasospastic angina
Cohort Study
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 71
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 160 participants with suspected VSA between October 2018 and April 2024 were selected. After the screening process, 71 participants were included in the analysis. The participants were divided into two groups according to the treatment received, with 50 and 21 participants in the traditional and immunomodulatory therapy groups, respectively.

Brief summary: Vasospastic angina (VSA) is caused by brief spasms of the main coronary artery and its major branches, resulting in varying degrees of luminal occlusion. Although vasodilator therapy is widely used and significantly alleviates VSA symptoms, it has not led to notable improvements in the prognosis of patients with VSA. Recent studies have suggested that inflammation plays a crucial role in VSA. This study aimed to evaluate the potential effectiveness of immunomodulatory therapy for improving patient prognosis.


Eligibility criteria: Inclusion Criteria:

(1) Transient total or subtotal occlusion of the coronary artery (contraction \>90%) observed either spontaneously or in response to irritant stimulation (typically acetylcholine, ergot, or hyperventilation); (2) Presence or absence of ischemic electrocardiogram changes during episodes; (3) Nitrate-responsive angina during spontaneous episode: rest angina and/or marked diurnal variation in exercise tolerance and/or episodes precipitated by hyperventilation and/or suppression of episodes by calcium channel blockers.

Exclusion Criteria:

(1) age 15 years or older; and (2) suspected VSA with chest pain and evidence of coronary spasm, or VSA diagnosed intraoperatively or at discharge.

The following exclusion criteria were applied: (1) failure to meet the diagnostic criteria for VSA; (2) presence of aortic disease, cardiomyopathy, malignant tumor, Kounis syndrome, or other diseases that may affect the outcome; (3) insufficient clinical data available; and (4) loss to follow-up.

Primary outcomes:
measure: adverse outcomes
timeFrame: From Feb 2017 to Feb 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT03951207: Rosuvastatin/Amlodipine vs Atorvastatin/Amlodipine in Hypertension Patient With Dyslipidemia
Official title: Randomized, Multicenter, Parallel, Open, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension Patient With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemias
Hypertension
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2019-05-15
Enrollment: 259
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension patient with Dyslipidemia


Eligibility criteria: Inclusion Criteria:

* Both man and woman who is over 19 years old
* Patient with dyslipidemia and hypertension
* Written informed consent

Exclusion Criteria:

* Triglyceride ≥ 400 mg/dL at screening
* Hypertensive patients who need antihypertensive medication except Amlodipine, β-blockers, RAS inhibitors
* sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg
* A history of rhabdomyolysis, myopathy
* Patient with hypersensitivity to Statin or Amlodipine
* Patients undergoing eGFR \<30 mL/min/1.73 m2 (MDRD) at screening
* AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease
* Creatine kinase (CK) level ≥ 5x ULN (upper limit of normal range)
* Contraindications stated in the Label of Rosuampin or Caduet
* Those participating in other clinical trials for investigational products at screening
* Patients deemed to be ineligible to participate in the trial by investigator

Primary outcomes:
measure: Rate of change from baseline to week 8 in LDL-Cholesterol
timeFrame: Baseline/Week 8
Secondary outcomes:
measure: Rate of change from baseline to week 4 in LDL-Cholesterol
timeFrame: Baseline/Week 4
measure: Proportion of subjects who reached the therapeutic goal to week 8
timeFrame: Week 8
measure: Rate of change from baseline to week 4, 8 in lipid profile(without LDL-C)
timeFrame: Baseline/Week 4, 8
measure: Rate of change from baseline to week 4, 8 in hs-CRP
timeFrame: Baseline/Week 4, 8
measure: Rate of change from baseline to week 4, 8 in glucose index
timeFrame: Baseline/Week 4, 8
measure: Rate of change from baseline to week 4, 8 in msSBP & msDBP in both arm
timeFrame: Baseline/Week 4, 8
measure: Rate of change from baseline to week 4, 8 in difference of msSBP & msDBP in both arm
timeFrame: Baseline/Week 4, 8
measure: The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)
timeFrame: Week 8
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic Univ. Medical Center
Study officials:
References:
Clinical trial NCT06659107: Percutaneous Kirschner Wires With Mutual Linking Technique in the Management of Proximal Humeral Fracture
Official title: Percutaneous Kirschner Wires With Mutual Linking Technique in the Management of Proximal Humeral Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proximal Humeral Fractures
Keywords: Proximal humeral fractures
Mutual linking
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is study evaluates a novel technique to improve the stability of K-wires used in the fixation of proximal humeral fractures


Eligibility criteria: Inclusion Criteria:

* both sexes
* Age from 60 to80 years
* 2 or 3 parts fracture
* recent injury less than 3 weeks

Exclusion Criteria:

* 4 parts fracture
* old injury more than 3 weeks
* previous surgeries or pathologies affecting shoulder range of motion

Primary outcomes:
measure: Functional outcome
timeFrame: One year
measure: Radiological outcome
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university hospitals
Study officials:
References:
Clinical trial NCT05828407: Fluid Challenge Impact in the Portal Vein Pulsatility Depending on the Fluid Responsivness Status
Official title: Fluid Challenge Impact in the Portal Vein Pulsatility Depending on the Fluid Responsivness Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Insufficiency
Venous Congestion
Keywords: Point of care ultrasound
Portal vein pulsatility index
Venous congestion
Preload dependence
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 36
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: Adult intensive care patients with both grade 1 or higher venous congestion (VeXus C criteria) and acute circulatory failure.

Brief summary: Portal vein pulsatility index is a marker of venous congestion evaluated by point of care ultrasound. It is associated with acute kidney injury, especially in critically ill patients. It may be considered as a dynamic marker. The investigators hypothesized that portal vein pulsatility index is higher after a fluid challenge only in patient without preload dependence in critically ill patients with cardiovascular insufficiency.


Eligibility criteria: Inclusion Criteria:

* vasopressor requirement to maintain mean arterial pressure \>65mmHg AND
* at least one of the following criteria:

  * arterial lactate \>2mmol/L;
  * capillary refill time \>3s;
  * mottling score \>1;
  * diuresis \<0,5mL/h for more than 6hours.

Exclusion Criteria:

* Diameter of vena cava \<20mm
* Cirrhosis
* Pregnancy
* Severe acute pulmonary edema
* Phototype 4 or 5
* Patient opposition to participate

Primary outcomes:
measure: Portal vein pulsatility index variation induced by the fluid challenge (%), defined by: Portal vein pulsatility index before the fluid challenge - portal vein pulsatility index after the fluid challenge.
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital cardiologique Louis Pradel
Study officials:
affiliation: Département d'anesthésie-réanimation
name: Martin RUSTE, MD
role: PRINCIPAL_INVESTIGATOR
References: