louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01592253: Study to Evaluate Safety and Immunologic Biomarker of Rapamune in Patients With Stable Renal Transplant Recipient
Official title: Investigation of the Safety and Immunologic Biomarker After Conversion From Calcineurin Inhibitor to Rapamune in Stable Renal Transplant Recipient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Rejection of Renal Transplant
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2012-05-07
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: For patients who meet the inclusion criteria and who agree to participate in this study, the investigators sampled peripheral blood 10cc and performed the analysis for immunologic profile just before the conversion of immune suppressant. At 1 month, 6 month, and 1 year from the conversion of Immune suppressant (CNI to rapamune), the investigators performed tha analysis fo immune profile again. During the study period, the interval of the visit of subclinic and the kinds of laboratory test (Blood and urine test) would not change compared to before the start of this study.


Eligibility criteria: Inclusion Criteria:

1. Renal transplant recipient who has passed at least 10 years
2. No acute rejection episode during the previous 6 months
3. No change of prescription of immune suppressants
4. Normal allograft function (MDRD eGFR \> 80 mL/min/1.73 m2)
5. Change of allograft function less than 10 % of baseline value durant the previous 1 year
6. No proteinuria and hematuria

Exclusion Criteria:

1. Patients who donut want to participate in this study
2. Patients who should continue immune suppressant due to another cause (e/g combined autoimmune disease)

Primary outcomes:
measure: biopsy proven acute rejection
timeFrame: Study duration is 12 months
Secondary outcomes:
measure: Serum Creatinine, MDRD eGFR
timeFrame: Study duration is 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Seoul St. Mary's Hospital
name: ChulWoo Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04756453: The Effect of Clip-traction on ESD Resection Time.
Official title: The Effect of Clip-traction on ESD Resection Time. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adenoma Colon
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients scheduled for an endoscopic submucosal dissection(ESD) in the colorectum will be randomized to the use of a traction device(consisting of an endoscopic clip with a loop of dental floss secured in the lesion to be removed, another clip will anchor the loop to adjacent bowel wall) or a standard ESD.

Detailed description: Patients with an adenoma or an early colorectal cancer treatable with endoscopic submucosal dissection will be randomized to the use of a traction device or a standard ESD. Location, morphology and size of the lesion will be recorded. Time of the procedure will be measured using a stopwatch

Eligibility criteria: Inclusion Criteria:

* a lesion in the colon or rectum suitable for removal by the ESD technique

Exclusion Criteria:

* dementia
* inability to understand the written study information

Primary outcomes:
measure: Resection speed (mm2/min)
timeFrame: Within completion of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Endoskopicentrum Danderyds Sjukhus
Study officials:
affiliation: Karolinska Institutet
name: Richard Marsk, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05708053: Cardio-protective Effect of Metformin in Patients Undergoing PCI
Official title: Cardio-protective Effect of Metformin in Patients Undergoing Elective Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Elective Percutaneous Coronary Intervention
Ischemic Reperfusion Injury
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
Collaborators: name: Cairo University
name: Cairo University Hospitals
First posted: 2023-02-01
Enrollment: 80
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: This is a two-arm randomized parallel study. Patients who will be meeting the above-mentioned criteria and agree to take part in the study, were asked to sign an informed consent prior conducting the study.

The whole study protocol were presented to the local institutional review board (IRB).


Eligibility criteria: Inclusion Criteria:

* Adult patients (age above 18)
* Undergoing elective PCI

Exclusion Criteria:

1. Hypersensitivity to metformin or any component of the formulation
2. Patients with current or any history taking metformin either for diabetes mellitus or any other reason such as polycystic ovarian syndrome.
3. Patients diagnosed with type 1 or 2 diabetes mellitus.
4. Any oral or injectable hypoglycemic therapy (e.g. insulin, sulfonylureas)
5. Severe renal dysfunction (eGFR less than 30 mL/minute/1.73 m2 ) from any cause, including shock or septicemia; acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis).
6. Treatment with systemic glucocorticoids within 3 months of randomization (due to its potential effect on plasma glucose and HbA1c levels).
7. Metabolic acidosis (total CO 2 below the laboratory lower limit of normal on most recent blood chemistry panel).
8. Need for coronary artery bypass grafting.
9. Participation in other clinical trial in the 30 days before enrollment.
10. The existence of a life-threatening disease with a life-expectancy of less than 6 months.

Primary outcomes:
measure: Postprocedural myocardial injury
timeFrame: 6 months
Secondary outcomes:
measure: CK-MB
timeFrame: 24 hours post PCI
measure: cTn
timeFrame: 24 hours post PCI
measure: LVEF in percent
timeFrame: Baseline- 6 months
measure: LVMI in g/m2
timeFrame: Baseline- 6 months
measure: GFR
timeFrame: Baseline- monthly- 6 months
measure: Serum creatinine (SCr)
timeFrame: Baseline- monthly- 6 months
measure: Lactate concentration
timeFrame: Baseline - 6 months
measure: Glucometabolic State
timeFrame: Baseline - 6 months
measure: Incidence of Cardiovascular Event
timeFrame: Baseline - 6 months
measure: Rate of hospitalization
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Pharmacy, Cairo University
city: Cairo
country: Egypt
facility: Kasr El Aini Hospital
city: Cairo
country: Egypt
facility: Kasr El-Aini Hospital
Study officials:
References:
Clinical trial NCT01779453: A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia
Official title: A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Drug Interaction Study to Evaluate the Safety, Tolerability and Effect on Atorvastatin Pharmacokinetics of ETC-1002 Added to Atorvastatin 10 mg/Day in Subjects With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Keywords: Atorvastatin
Drug-drug interaction
Combination therapy
Lead sponsor: Esperion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-30
Enrollment: 58
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 study will assess the safety, atorvastatin pharmacokinetics, and LDL-C lowering efficacy of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy of atorvastatin 10 mg.


Eligibility criteria: Inclusion Criteria:

* For subjects on current daily statin therapy - LDL-C 100-220 mg/dL and triglycerides \<350 mg/dL (prior to switching to sponsor -provided atorvastatin 10 mg/day and stopping all other lipid-regulating drugs and supplements) at the S1 Visit,
* For subjects not on current daily statin therapy - LDL-C ≥ 110 mg/dL and ≤ 220 mg/dL

Exclusion Criteria:

* Acute significant cardiovascular disease
* Uncontrolled hypertension

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites
timeFrame: 4 and 8 weeks
measure: Peak plasma concentration (Cmax) of atorvastatin and its active metabolites
timeFrame: 4 and 8 weeks
measure: Number of subjects with adverse events, clinical lab abnormalities and other safety findings
timeFrame: 8 weeks
Secondary outcomes:
measure: Percent change in LDL-C
timeFrame: 2, 4, 6 and 8 weeks
measure: Percent change in other lipids and cardio-metabolic risk factors
timeFrame: 2, 4, 6 and 8 weeks
Other outcomes:
measure: Area under the plasma concentration versus time curve (AUC) and peak plasma concentration (Cmax) of ETC-1002 and its active metabolite
timeFrame: 4 and 8 weeks
Locations:
city: Indianapolis
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Esperion Therapeutics, Inc.
name: Noah Rosenberg, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04840953: Negative Pressure Therapy, Minimally Invasive and Accessible Technique in the Treatment of Massive Subcutaneous Emphysema in COVID-19 or Non Infected Critical Patients
Official title: Negative Pressure Therapy, Minimally Invasive and Accessible Technique in the Treatment of Massive Subcutaneous Emphysema in COVID-19 or Non Infected Critical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subcutaneous Emphysema
Covid19
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subcutaneous emphysema that compromises ventilation with or not SARS COV2 infection

Brief summary: Background Numerous surgicals treatments have been described for the massive subcutaneous emphysema; however, some of these techniques cannot be carried out in a critical care unit and they are related with high morbidity and exposure in positive SARS COV-2 patients. More effective, less invasive and isolated procedures should be implemented.

Technique Negative pressure therapy (NPT) that can allow effective solving of massive subcutaneous emphysema in a short period (5 days) with a minimally invasive approach at the bedside in Covid-19 or non infected critical patients.

Conclusion NPT is an effective and low invasive strategy for the management of EES in critical patients with high risk of mortality.


Eligibility criteria: Inclusion Criteria:

* Subcutaneous emphysema that compromises ventilation

Exclusion Criteria:

* Declined Therapy

Primary outcomes:
measure: Resolution time of emphysema with negative pressure therapy
timeFrame: Days
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
Study officials:
References:
Clinical trial NCT00791453: Clarksdale Diabetes and Metabolism Clinic CHEC Study
Official title: Clarksdale Diabetes and Metabolism Clinic Consumer Health Education Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Diabetic patients at the Clarksdale Diabetes
and Metabolism Clinic and must be between the
ages of 18 and 64 years of age.
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2008-11-14
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Established patients at a diabetes clinic.

Brief summary: This study will involve established clinic patients. The Rapid Estimate of Adult Literacy in Medicine will be administered during patients' regular clinic visits. Patients will then be referred to the Consumer Health Education Center (CHEC)by healthcare providers who will fill out a referral form. The form will be given the the CHEC health educator who will assist patients in finding literacy-appropriate health information. BMI and Hgb A1c values will be compared after 3 months and 6 months to baseline values. It is hypothesized that objective assessment of patient use of literacy-appropriate, health information from the Clarksdale Diabetes and Metabolism Clinic CHEC will improve Hgb A1c and BMI values among patients.


Eligibility criteria: Inclusion Criteria:

* Established patients of the Clarksdale Diabetes and Metabolism Clinic between the ages of 18 and 64.

Exclusion Criteria:

* Individuals who are not established patients of the clinic and are not between the ages of 18 and 64.

Primary outcomes:
measure: Hgb A1C and BMI measurements will improve
timeFrame: 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: The University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: The University of Mississippi Medical Center
name: Jacinda B. Roach, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05484453: Validation of the GoCheck Kids® Eye Screeningtest in Infants in Flanders
Official title: Validation of the Eye Screeningtest GoCheckKids (GCK) for the Detection of Amblyopia Risk Factors in Toddlers in Flanders.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Amblyopia
Infant
Keywords: Eye screening
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 460
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who undergo GCK evaluation at the Child And Family Agency consultation

Brief summary: The aim is to validate the new GoCheck Kids application as automatic eye screener for preschool children (\<3 years of age) at 'Child and Family' agency. Sensitivity, specificity, positive and negative predictive value of the GoCheck Kids screening tool are the endpoints of this study.

Detailed description: Comparison of the results of the GoCheck Kids application on iPhone with a complete eye examination (gold standard) including cycloplegic refraction with retinoscopy, performed by an ophthalmologist.

Eligibility criteria: Inclusion Criteria:

* GoCheck Kids (GCK) evaluation at Child and Family Agency at the age between 11-16 months.

Exclusion Criteria:

* Allergy for the used cycloplegia cyclopentolate 0.5%.
* Any history of ocular surgery
* The time window between GCK measurement and the complete eye examination may not exceed 2 months.
* The parents or legal representatives of the child do not understand or speak Dutch, French or English.

Primary outcomes:
measure: Sensitivity
timeFrame: Day 1
measure: Specificity
timeFrame: Day 1
measure: Positive predictive value
timeFrame: Day 1
measure: Negative predictive value
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Catherine Cassiman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00896753: Gene Expression Profiling in Normal Tissue and Tumor Tissue From Patients With Colon Cancer That Has Spread to the Liver, Lungs, or Peritoneum
Official title: Gene Expression Profiling of Metastatic Colon Cancer (CCCWFU 89B03)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Metastatic Cancer
Keywords: stage IV colon cancer
liver metastases
lung metastases
recurrent colon cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 10
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with metastatic colen cancer

Brief summary: RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This laboratory study is using gene expression profiling to evaluate normal tissue and tumor tissue from patients with colon cancer that has spread to the liver, lungs, or peritoneum.

Detailed description: OBJECTIVES:

* Evaluate gene expression profiles in normal and tumor tissue from patients with colon cancer metastatic to the liver, lungs, or peritoneum.
* Establish cell lines from primary colon tumors metastatic to the liver, lungs, or peritoneum.
* Determine the specific gene expression changes that result in the manifestation of the drug-resistant phenotype for each metastatic site.

OUTLINE: This is a pilot study.

Tumor and normal tissue collected during surgery are analyzed for gene expression profiling by cDNA microarray. Tissue is also analyzed for thymidylate synthase (TS) gene expression by quantitative PCR and for protein expression by western blot. Gene expression patterns are correlated with TS levels.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of colon cancer metastatic to the liver, lungs, or peritoneum

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Gene expression changes that occur at each metastatic site (i.e., liver, lungs, and peritoneum)
timeFrame: day 1
measure: Development of cell lines from primary colon tumors metastatic to the liver, lungs, or peritoneum
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Perry Shen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05996653: CEST in Low-grade Glioma Study
Official title: A Multi-institutional Observational Study of CEST Imaging in Low-grade Glioma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low-grade Glioma
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Low grade gliomas (LGGs) are malignant, infiltrative and incurable brain tumours that typically present in the younger population. This project proposes to use non-contrast metabolic "Saturation Transfer" (ST)-MRI to evaluate LGG tumour progression and aims to predict early changes in LGG. Early identification of LGG patients whose tumours will progress will permit early interventions. ST-MRI does not involve any intravenous injection of contrast and which acquires metabolic information not seen by standard MRI.

Detailed description: Please see trial details below:

Eligibility criteria: Inclusion Criteria:

1. Be at least 12 years of age;
2. Diagnosed with:

   1. Cohort A (pre-surgical): Suspected LGG (oligodendroglioma or astrocytoma), based on any combination of histological, molecular, radiological, and/or clinical findings; or
   2. Cohort B (post-surgical): IDH1/2-mutant or IDH-wildtype (WT) low-grade glioma candidate for observation
3. No contraindications to MRI;
4. eGFR \> 30 ml/min;
5. No prior chemotherapy or radiation therapy;
6. No need for upfront treatment (surgery, chemotherapy, and/or radiation therapy)
7. Followed at either Sunnybrook Health Sciences Centre or at St Michael's Hospital

Exclusion Criteria:

1. Need for upfront post-surgical treatment with either chemotherapy and/or radiation therapy
2. Pregnancy

Primary outcomes:
measure: The time-to-progression as measured by Saturation Transfer (ST)-MRI (based on a change in volume or parameter value of over 10%) relative to the time-to-progression as measured by standard MRI using RANO-LGG.
timeFrame: Up to 6 years, from date of initial (ST)-MRI scan until the date of progression
Secondary outcomes:
measure: Accuracy of Saturation Transfer (ST)-MRI for detecting progression (based on a change in volume or parameter value of over 10%).
timeFrame: Up to 6 years, from date of initial (ST)-MRI scan until the date of progression
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Greg J Stanisz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02707653: Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research
Official title: Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incomplete Abortion
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Department of Medical Research, Lower Myanmar
First posted: 2016-03-14
Enrollment: 75
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the use of misoprostol for first-line treatment of incomplete abortion at tertiary hospitals in Myanmar.

Detailed description: This open-label feasibility study seeks to examine the potential of 400μg sublingual misoprostol for the treatment of incomplete abortion provided at tertiary hospitals.

Eligibility criteria: Inclusion Criteria:

1. Confirmed incomplete abortion
2. No known contraindications to the study drug
3. Uterine size no larger than 12 weeks at time of presentation for care
4. No signs of severe infection, defined as at least two of the following:

   * foul smelling discharge,
   * fever \> 38 degrees C, 100 degrees Fahrenheit
   * uterine tenderness.
5. No hemodynamic disturbances (pulse \>110/min and systolic bp \<100)
6. General good health
7. Agree to comply with study procedures including return for follow up visit
8. Live or work within one hour from a study site
9. Willing and able to sign consent forms

Exclusion Criteria:

1. Inability to provide informed consent

Primary outcomes:
measure: Percentage of women with complete uterine evacuation with study medication alone.
timeFrame: 14 days
Secondary outcomes:
measure: Percentage of women experiencing side effects
timeFrame: 7-14 days
measure: Level of self-reported acceptability of treatment
timeFrame: 7-14 days
Other outcomes:
Locations:
city: Yangon
country: Myanmar
facility: Central Woman's Hospital
city: Yangon
country: Myanmar
facility: Thingyan Sanpya Hospital
Study officials:
References: