louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04973891: CANA/Met in Non-diabetic Women With PCOS
Official title: Canagliflozin Administration in Non-diabetic Women With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome (PCOS), which is associated with hyperinsulinaemia, hyperandrogenaemia, impaired glucose metabolism and aberrant adipokines production from the adipose tissue, is a heterogeneous reproductive and endocrine disorder.Currently, metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS. SGLT-2 inhibitor, a novel glucose-lowering medication, have been shown to have positive effects on reducing body weight, blood pressure and cardiovascular events in individuals with diabetes mellitus. However, evidences related to its management in non-diabetic PCOS women are limited. Hence, we want to give canangliflozin combined with metformin to women with PCOS to see its effect on insulin resistance.


Eligibility criteria: Inclusion Criteria:

1. Female aged 18- 45 years old;
2. Diagnosed criteria meet the Rotterdam criteria (2003);
3. Insulin Resistance

Exclusion Criteria:

1. Women who are pregnant or have a pregnancy plan within six months;
2. Confirmed diagnosis of diabetes.
3. Congenital adrenocortical hyperplasia;
4. Hyperprolactinemia;
5. Hyperthyroidism or hypothyroidism;
6. Combined with liver or kidney diseases;
7. Abnormal liver function (≥ 3 times of the upper limit of normal range);
8. Abnormal renal function (GFR\<60ml/min/1.73m2);
9. Adrenal or ovarian tumors secreting androgens;
10. Used metformin, glucagon-like peptide-1 receptor agonists, pioglitazone and contraceptives in the last 3 months.

Primary outcomes:
measure: Body mass index
timeFrame: Three months
Secondary outcomes:
measure: Total testosterone
timeFrame: Three months
measure: Androstenedione
timeFrame: Three months
measure: Dehydroepiandrosterone sulfate
timeFrame: Three months
measure: Sex hormone-binding globulin
timeFrame: Three months
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
Study officials:
References:
citation: Zhang J, Xing C, Cheng X, He B. Canagliflozin combined with metformin versus metformin monotherapy for endocrine and metabolic profiles in overweight and obese women with polycystic ovary syndrome: A single-center, open-labeled prospective randomized controlled trial. Front Endocrinol (Lausanne). 2022 Sep 6;13:1003238. doi: 10.3389/fendo.2022.1003238. eCollection 2022.
Clinical trial NCT01917591: Healing of Punch Graft Wounds. Comparative Study Between MariGen and Oasis: a Non-inferiority Study
Official title: Healing of Punch Graft Wounds With Two Biologic Exracellular Matrices; a Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Punch Biopsy Wounds
Healing Times
Keywords: Bandages
Biological Dressings
Chronic Disease
Collagen
Epithelium
Extracellular Matrix
Extra Cellular Matrix
Fibroblasts
Granulation Tissue
Leg Ulcer
Middle Aged
Prospective Studies
Soft Tissue Injuries
Treatment Outcome
Varicose Ulcer
Wound Healing
Wounds and Injuries
biopsy
autoimmunity
Lead sponsor: Kerecis Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-06
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to determine, if healing of punch biopsy wounds treated with the fish skin derived MariGen Wound dressing is non-inferior to healing with wounds treated with pig intestines derived Oasis Sheet wound dressing. Secondary endpoints are: Incidence of erythema, Pain, Infection, Quantitative measurements of autoantibodies at baseline and 4 weeks after start of treatment


Eligibility criteria: Inclusion Criteria:

* \>18 yrs
* Healthy individual
* Signature of informed consent

Exclusion Criteria:

* Autoimmune disease
* Immunosuppressive treatment
* Use of addictive drugs
* Excessive use of alcohol
* Known fish allergy
* Known allergy to proteins with porcine origin
* Peripheral vascular disease
* Pregnant women
* Persons receiving anticoagulation therapy or systemic corticosteroids will be excluded.

Primary outcomes:
measure: wound healing
timeFrame: 28 days
Secondary outcomes:
measure: Autoimmune investigations
timeFrame: 28 days
measure: Incidence of erythema
timeFrame: 28 days
measure: Pain at wound site
timeFrame: 28 days
measure: Infection
timeFrame: 28 days
Other outcomes:
Locations:
city: Reykjavik
country: Iceland
facility: Læknastofur Skipholti
Study officials:
affiliation: The National University Hospital of Iceland
name: Hugrun Thorsteinsdottir, MD Derm
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05718791: CXCL9 and EASIX for Prediction of Acute Graft Versus Host Disease
Official title: CXC-chemokine Ligand 9 (CXCL9) and Endothelial Activation and Stress Index (EASIX) for Prediction of Acute Graft Versus Host Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GVHD,Acute
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \>18 year old admitted for allo SCT PB for malignant disease

Brief summary: The prediction of severe acute GVHD before it occurs is of high importance for ensuing clinical decisions and overall success of allogeneic SCT. The key immunologic signatures associated with clinical outcomes after different graft versus host disease prophylaxis methods or peripheral blood stem cell transplant are largely unknown.


Eligibility criteria: Inclusion Criteria:

* Patients \>18 year old admitted for allo SCT PB for malignant disease.

Primary outcomes:
measure: predictors of acute GVHD
timeFrame: CXCL9 combined with EASIX calculated at day 28 +/- 2 post SCT can be used as predictors of acute GVHD by day 100.
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References:
Clinical trial NCT01979991: Model-Based Image Reconstruction for X-Ray CT in Lung Imaging
Official title: Model-Based Image Reconstruction for X-Ray CT in Lung Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Diseases
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: General Electric
First posted: 2013-11-08
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To develop a computer program that will improve CT image quality and decrease the amount of x-ray radiation that future patients may be exposed to when they have a CT examination.

Detailed description: We will be asking patients for their permission to save and use the sinogram from their CT scan. The sinogram will be de-identified and sent to an archive system for storage. It will be exported to a computer for processing using MBIR (model based iterative reconstruction). MBIR (model based iterative reconstruction) is a new method being developed to process CT sinograms. The newly reconstructed images will be reviewed by experts to determine if they are as readable and accurate as CT images created with the software that is currently being used. Sinogram data and the reconstructed images will be shared with collaborating researchers at General Electric Global Research.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age and older 2. No medical or psychiatric condition precluding informed consent

-

Exclusion Criteria:

1. Inability to lie flat on the back with arms raised over the head for 30min.
2. Metallic implants or metallic devices in the chest or back.
3. Participation in other research trials involving ionizing radiation

Primary outcomes:
measure: Developement of a computer program to improve CT image quality
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Jeffrey Fessler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Jeffrey Fessler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00928694: Fenofibrate Bioequivalence Study (0767-031)
Official title: An Open-Label, Randomized, 2-Period, Crossover Study to Determine Definitive Bioequivalence After Administration of Single 160 mg Doses of the U.S. and UK Formulations of Fenofibrate in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will determine definitive bioequivalence of the United States (U.S.) and United Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Subject is in good health
* Subject is willing to follow all study guidelines

Exclusion Criteria:

* Subject has uncontrolled high blood pressure, impaired glucose tolerance, diabetes, or other major diseases or chronic conditions that would confound the results of the study or make participation unsafe
* Female subject is receiving oral contraceptives or hormone replacement therapy

Primary outcomes:
measure: Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid
timeFrame: Predose and up to 168 hours postdose
measure: Maximum Plasma Concentration (Cmax) of Fenofibric Acid
timeFrame: Predose and up to 168 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00296894: Study to Evaluate the Efficacy of Adalimumab in Patients With Erosive Osteoarthritis of the Interphalangeal Finger Joints
Official title: TNF-Blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints: Randomized, Double Blind, Placebo-Controlled Cross-Over Study to Evaluate the Efficacy of Adalimumab 40 mg SC Every Other Week in Patients With Erosive Osteoarthritis of the Interphalangeal Finger Joints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erosive Osteo-Arthritis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients will be randomized into two groups (1/1) during one year:

* 40 mg adalimumab subcutaneously (sc) every other week
* placebo

The effect on x-rays and clinical parameters will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Clear erosive image on x-ray of at least one interphalangeal finger joint

Primary outcomes:
measure: Evaluation of x-rays
measure: Evaluation of clinical parameters (pain, daily functioning, etc.)
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Gust Verbruggen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05840094: Multimodalitic Imaging in the N-stage of Lung Cancer
Official title: A Prospective Study of the Predictive and Prognostic Value of Multimodalitic Imaging in the N-stage of Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasm of Lung
Keywords: 18F-FDG PET/CT
Neoplasm of Lung
EBUS-TBNA
MR STIR
NSCLC N-stage
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to evaluate the diagnostic efficacy and differences between 18F-FDG PET/CT and MR STIR sequences combined with EBUS-TBNA, 18F-FDG PET/CT combined with EBUS-TBNA, and MR STIR sequences combined with EBUS-TBNA - three types of multimodal imaging for assessing NSCLC N-stage, in order to select the best assessment protocol to guide treatment decisions and prognostic assessments.


Eligibility criteria: Inclusion Criteria:

* Biopsy pathologically confirmed NSCLC, or clinically highly suspicious NSCLC (assessed as highly suspicious by the MDT team of this study);
* N1, N2, or N3 confined to the mediastinum and hilum, as assessed by imaging;
* Proposed systematic lymph node dissection without any treatment;
* Appropriate laboratory tests (serum tumor markers);
* All examination intervals ≤ 4 weeks;
* KPS score ≥ 50 (ECOG/WHO equivalent);
* Aged \> 18 years; 8. Patients can fully understand and voluntarily participate in this trial and sign the informed consent; the examination can be completed independently.

Exclusion Criteria:

* Contraindication to EBUS-TBNA operation;
* Presence or history of other malignancies within 10 years;
* Inability to understand the examination procedure or to cooperate.

Primary outcomes:
measure: The diagnostic efficacy of18F-FDG PET/CT and MR STIR sequences combined with EBUS-TBNA in the lymph node staging of NSCLC
timeFrame: 1 year
Secondary outcomes:
measure: The diagnostic efficacy of18F-FDG PET/CT combined with EBUS-TBNA in the lymph node staging of NSCLC
timeFrame: 1 year
measure: The diagnostic efficacy of18F-FDG PET/CT combined with MR STIR in the lymph node staging of NSCLC
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00318994: Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis
Official title: Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreatitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To measure meropenem pancreatic tissue penetration in subjects with severe pancreatitis requiring surgery between 30 to 60 minutes after a bolus of 1 g IV meropenem given during the induction period of anesthesia.


Eligibility criteria: Inclusion Criteria:

* Subjects with diagnosis of severe pancreatitis requiring surgery according to the protocol of each Institution.
* Informed consent signed by the subject
* Subjects who have received prophylactic antibiotics for previous invasive procedures different from surgery may be included

Exclusion Criteria:

* Will of the subject not to be included
* Subjects who have not signed the informed consent
* Subjects with known hypersensibility to carbapenems, penicillins, or cephalosporins

Primary outcomes:
measure: To measure meropenem pancreatic tissue penetration in subjects with severe pancreatitis requiring surgery between 30 and 60 minutes after a bolus of 1 g IV meropenem applied during induction of anesthesia.
Secondary outcomes:
measure: To describe the incidence of infectious complications during the first 30 days after surgery in subjects with severe pancreatitis receiving IV meropenem at a dose of 1 g every 8 hours during 14 days.
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Columbia Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03727594: Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma
Official title: Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Cavity Squamous Cell Carcinoma
Oropharyngeal Squamous Cell Carcinoma
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected by oral cavity or oropharyngeal squamous cell carcinoma admitted to our clinic.

Brief summary: The purpose of the study is to assess the role of lymphoscintigraphy as a simple and widely accessible method with a favorable cost/benefit ratio in improving oral cavity and oropharyngeal squamous cell carcinoma staging and surgical appropriateness and implementing a tailored surgical approach to cervical lymph node dissection.


Eligibility criteria: Inclusion Criteria:

* accepted informed consent
* preoperative histological diagnosis of oral cavity or oropharyngeal squamous cell carcinoma
* patients fit to surgery of the primitive tumor and neck dissection (according to the general health condition and the clinical tumor stage)

Exclusion Criteria:

* rejected informed consent
* patients not fit to surgery (according to the general health condition and the clinical tumor stage)
* pregnant women

Primary outcomes:
measure: Number of patients with atypical lymphatic drainage of oral cavity and oropharyngeal squamous cell carcinoma identified through lymphoscintigraphy
timeFrame: 5 years
measure: Number of metastasis or micrometastasis in the "sentinel" lymphnodes identified through immunofluorescence analysis of pancytokeratins
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Disease-free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: University Hospital of Ferrara
Study officials:
References:
Clinical trial NCT00149994: Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients
Official title: DELTA Study Dutch Evaluation in Liver Transplantation To Assess the Efficacy of Cyclosporine A Microemulsion With C-2h Monitoring Versus Tacrolimus With Trough Monitoring in de Novo Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Transplant
Keywords: Liver transplant, adults, C2 monitoring
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether cyclosporine A (in a micro emulsion formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or superior efficacy compared to tacrolimus monitored by pre-dose blood concentration (C-0h). In addition this study will assess the safety and tolerability of a cyclosporine A regimen based on C-2h monitoring in comparison to the standard tacrolimus regimen.


Eligibility criteria: Inclusion Criteria:

* About to undergo a primary liver transplant (including living donor, non-heart beating donor and split liver).
* Age between 18 and 75 years.
* Expected to be able to receive the first oral dose of CNI within the first 24 hours post-transplantation (Tx)

Exclusion Criteria:

* This is a multi-organ transplant or if the patient has previously been transplanted with any other organ.
* Urine production is \<200 ml within 12 hours after reperfusion of the graft
* Severe coexisting disease is present or if any unstable medical condition is present which could affect the study objectives.

Other protocol-defined exclusion criteria applied

Primary outcomes:
measure: Percentage of Participants With an Occurrence of Biopsy Proven Acute Rejection (BPAR) During the First 3 Months Post de Novo Liver Transplantation.
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: