louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01654354: Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) With Ultravist 370 INJ.(Iopromide 768.86mg) in Abdominal CT
Official title: Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) With Ultravist 370 INJ.(Iopromide 768.86mg) in Abdominal CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal CT
Keywords: Qualitative Evaluation of abdominal CT image using 4 point scale: Excellent(4)/ Good(3) / Fair(2) / Unacceptable(1)
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject who performed scheduled CT scan, mostly postoperative state of stomach cancer

Brief summary: Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) with Ultravist 370 INJ.(Iopromide 768.86mg) in abdominal CT


Eligibility criteria: Inclusion Criteria:

* Aged 20 to 75 years old.
* Subjects who need CT scan
* Subjects who are willing to participate in the study and to write the informed consent form.

Exclusion Criteria:

* Subjects with severe hepatopathy whose AST or ALT ≥ 1,000 IU/L, Subjects with liver cirrhosis whose AST or ALT ≥ UNL(upper normal limit) X 3
* Severe disorder of thyroid gland
* homocystinuria
* pregnant or breastfeeding female subjects, or female subjects with childbearing potential who are not willing to use proper contraception methods
* Participation in another clinical trial within 30days of enrollment into this study.

Primary outcomes:
measure: imaging quality
timeFrame: end of study enrollment
measure: Adverse reaction
timeFrame: immediate after CT scan
Secondary outcomes:
measure: SNR (signal to noise ratio) / CNR (contrast to noise ratio)
timeFrame: at the end or enrollment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05506254: Long-term Follow-up Study of Patients Who Received hLB-001 Gene Therapy
Official title: A Long-term Follow-up Study of Patients in LogicBio Clinical Trials for Methylmalonic Acidemia Characterized by MMUT Mutations Who Received hLB-001
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Methylmalonic Acidemia
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Alexion Pharmaceuticals, Inc.
First posted: 2022-08-18
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a non-interventional long-term follow-up study of participants who have participated in LogicBio studies for the treatment of MMA and received hLB-001.

Brief summary: This is a non-interventional long-term follow-up study of patients who have participated in LogicBio studies for the treatment of MMA and received hLB-001

Detailed description: Patients will be followed for a period of 15 years which includes the duration of time that the patient was in the treatment study.

Eligibility criteria: Inclusion Criteria:

* Participant has previously participated in a LogicBio clinical trial and received hLB-001.

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Clinical Trial Site
state: Georgia
city: Pittsburgh
country: United States
facility: Clinical Trial Site
state: Pennsylvania
city: Nashville
country: United States
facility: Clinical Trial Site
state: Tennessee
city: Seattle
country: United States
facility: Clinical Trial Site
state: Washington
Study officials:
References:
Clinical trial NCT06291454: GCF Levels of Chemokines in Periodontitis
Official title: CCL19/MIP3beta and CCL20/MIP3alpha Levels in the Gingival Crevicular Fluid of the Patients With Stage III Grade B and C Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 72
Sex: ALL
Minimum age (years): 22
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Group 1: Stage III Grade B periodontitis group
* Group 2: Stage III Grade C periodontitis group
* Group 3: Periodontally healthy control group

Brief summary: This study aimed to determine CCL19/MIP3beta(β) and CCL20/MIP3alpha(α) in the gingival crevicular fluid (GCF) of the patients with different periodontitis phenotypes.

A total of 72 individuals, 24 with Stage III Grade B periodontitis (Group 1), 24 with Stage III Grade C periodontitis (Group 2), and 24 periodontally healthy (control group) (Group 3), were included in the study. GCF and clinical periodontal parameters were obtained at baseline. MIP3β and MIP3α levels in GCF were determined by ELISA.


Eligibility criteria: Inclusion Criteria:

* Have at least 20 natural teeth, excluding third molars.
* Periodontitis patients had at least two non-adjacent sites per quadrant with probing depth (PD) ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm with gingival inflammation, and alveolar bone loss affecting \>30% of the teeth, as detected on clinical and radiographical examinations.
* Periodontally healthy control group had no sign of gingival inflammation, no PD \> 3mm and no evidence of attachment or bone loss

Exclusion Criteria:

* History of systemic disease.
* Regular use of any drugs which can effect the immune system or inflammatory response in the 6 months preceding the start of the study.
* Periodontal treatment during last 6 months that could affect periodontal status.
* Smoking.
* History of radiotherapy or chemotherapy.
* Current pregnancy, lactation or menopause.

Primary outcomes:
measure: CCL19/MIP3beta(β) levels
timeFrame: Baseline
measure: CCL20/MIP3alpha(α) levels
timeFrame: Baseline
Secondary outcomes:
measure: CCL19/MIP3beta(β) levels and clinical parameters
timeFrame: Baseline
measure: CCL20/MIP3alpha(α) levels and clinical parameters
timeFrame: Baseline
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Ordu University, Faculty of Dentistry
Study officials:
References:
Clinical trial NCT00223054: Polymorphism of the Cytochrome P450-system in Renal Transplants
Official title: Polymorphism of the Cytochrome P450-system and the MDR-system in Renal Transplants Receiving the Immunosuppressive Drugs Tacrolimus, Sirolimus, Everolimus or Cyclosporine A
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Function of Renal Transplant
Keywords: cyclosporin A
Tacrolimus
Everolimus
Sirolimus
Fluvastatin
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: University of Kiel
First posted: 2005-09-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patinets after kidney transplantation

Brief summary: In this study the researchers want to investigate genetic polymorphisms of cytochrome 450 enzymes and the multiple drug resistance (MDR) gene in renal transplant patients to look for differences in dosing of immunosuppressive drugs (tacrolimus, sirolimus, everolimus, cyclosporine A).

All patients who receive one of these drugs can be included and drug blood trough levels, dosing and genetics are compared.

Detailed description: Primary endpoint is the

1. serum creatinine in patients with and without polymorphysms
2. rate of rejections in patients with and without polymorphysms

Eligibility criteria: Inclusion Criteria:

* Renal transplant patients receiving one or more of the following drugs:

  * tacrolimus
  * sirolimus
  * everolimus
  * cyclosporin A
  * fluvastatin
* Informed consent given by the patient

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
Study officials:
affiliation: University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
name: Lutz Renders, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Renders L, Frisman M, Ufer M, Mosyagin I, Haenisch S, Ott U, Caliebe A, Dechant M, Braun F, Kunzendorf U, Cascorbi I. CYP3A5 genotype markedly influences the pharmacokinetics of tacrolimus and sirolimus in kidney transplant recipients. Clin Pharmacol Ther. 2007 Feb;81(2):228-34. doi: 10.1038/sj.clpt.6100039. Epub 2006 Dec 27.
Clinical trial NCT04849754: Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy
Official title: Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy for the Follow-up of Patients With Transthyretin Amyloidosis Treated With Tafamidis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Amyloidosis
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Recently, treatment with tafamidis in patients with cardiac ATTR lead to a significant reduction in mortality. The Perugini score is commonly used on planar bone scans to differentiate cardiac ATTR from other amyloidosis or normal patients but fails to evaluate amyloid burden and patient prognosis. Although semi-quantitative methods have been suggested to evaluate the amyloid burden, there a need for quantitative methods for longitudinal assessment of the disease.

Detailed description: Cardiac amyloidosis is a cause of restrictive cardiomyopathy with preserved ejection fraction associated with amyloid fibrils deposits in the myocardium. Two types of amyloid commonly infiltrate the heart: immunoglobulin light-chain amyloid (AL), and transthyretin-related amyloid amyloidosis (ATTR). Cardiac imaging is currently used for the diagnosis of ATTR, including planar scintigraphy with bone seeking radiopharmaceuticals, cardiac magnetic resonance and echocardiography with global longitudinal strain assessment.Although semi-quantitative methods have been suggested to evaluate the amyloid burden, there a need for quantitative methods for longitudinal assessment of the disease.

Eligibility criteria: Inclusion Criteria:

* Patient, male or female, over 18 years of age
* Patient diagnosed with transthyretin cardiac amyloidosis confirmed by scintigraphy
* Patient with signed consent

Exclusion Criteria:

* Patients with systemic AL amyloidosis
* Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Measurement of SUVmax by quantitative analysis by bisphosphonate scintigraphy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital privé Le Bois
Study officials:
affiliation: Hôpital Privé Le Bois
name: Fredric MOUQUET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04260854: Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery
Official title: Locally Administered Bupivacaine Hydrochloride for Post-operative Pain Control in Cutaneous Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Pain, Postoperative
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the addition of bupivacaine HCl injections will improve pain control after skin surgery.

This is a randomized clinical trial. Approximately 100 participants will be randomized to receive either bupivacaine HCl or saline injections to help with the postsurgical pain. Patients will be provided with a take-home journal to complete indicating when and how much pain medication they required for the 3 days immediately following surgery. Participants will return the journal in-person at a follow up visit 7-21 days post-op. This study was a pilot study designed to determine the feasibility of this procedure.

Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be invited and considered for enrollment.


Eligibility criteria: Inclusion Criteria:

1. \>18 years of age
2. Receiving cutaneous surgery
3. In good general health as assessed by the investigator

Exclusion Criteria:

1. Participants with an allergy to bupivacaine or other amide anesthetics
2. Participants unwilling to sign an IRB approved consent form
3. Participants with a contraindication to narcotic medication
4. Participants who are pregnant or will become pregnant
5. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible

Primary outcomes:
measure: Reported opioid and non-opioid pain medications taken
timeFrame: 3 Days Post-Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03105154: Groin Wound Infection Rate Using Prevena Compared to Standard Dressing in Vascular Surgery Patients With High Risk
Official title: Experience With the Negative Pressure Incision Management System (Prevena) in Vascular Surgery Patients With High Risk for Groin Wound Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endovascular Procedures
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient will be randomized sequentially to Prevena alternating with standard of care dressing
Primary purpose: TREATMENT

Brief summary: Evaluate wound healing using Prevena compared to standard dressings in high risk patients after vascular surgery.

Detailed description: Patients submitted to bilateral femoral endarterectomy will have one groin dressed with PrevenaTM and the contralateral one dressed with conventional bandage immediately after suture. Both PrevenaTM and the conventional bandage at the contralateral side will be removed before the patient discharge. Groin wound complications such as deep space infection, cutaneous cellulitis, dehiscence or re-interventions for wound-related complications will be observed in a 30-day evaluation window. This observation will be performed during the patient admission and in the post-operative standard of care visits among the first 30 days.

Eligibility criteria: Inclusion Criteria:

* Patients with known bilateral vascular peripheral disease who are being evaluated for possible bilateral femoral endarterectomy
* Patients with one or more risk factor (diabetes mellitus, Obesity, heavy smoker, immunodeficiency disease, groin reoperation, prosthetic)
* Patients in follow-up at Clinic in the Vascular Surgery Department
* Sign of informed consent
* English speaking

Exclusion Criteria:

* Refusal to participate
* pregnancy
* unilateral femoral endarterectomy
* subjects for whom Prevena IMS is contraindicated

Primary outcomes:
measure: % of infection at 30 days
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Clevealnd Clnic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Leveser Kirksey
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04349254: Observational Study of Vision Improvement in Late Stage Dry AMD Patients
Official title: Observational Study of Vision Improvement in Late Stage Dry AMD Patients by a Low Vision Aid Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Age-related Macular Degeneration
Keywords: Dry AMD
Lead sponsor: Optimal Acuity Corporation
Sponsor class: INDUSTRY
Collaborators: name: Bochner Eye Institute
First posted: 2020-04-16
Enrollment: 17
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with vision impairment due to late stage dry age-related macular degeneration.

Brief summary: The purpose of this study is to assess the vision improvement achieved by patients with late stage dry age-related macular degeneration who received corneal treatments by a low vision aid device.

Detailed description: The purpose of this study is to assess the vision improvement achieved by patients with late stage dry age-related macular degeneration who received corneal treatments by a low vision aid device. Patient records for patients with at least 12 months follow-up will be analyzed to determine measures of vision improvement including best spectacle-corrected distance and near visual acuity. Analyses will include descriptive statistics and correlation between outcomes and baseline characteristics.

Eligibility criteria: Inclusion Criteria:

1. - Male or female
2. - Any race
3. - Patient is at least 50 years old
4. - Patient has diagnosed late stage dry age-related macular degeneration in one or both eyes.
5. - Treated eyes were pseudophakic at the time of treatment.
6. - Patient had moderate to severe baseline vision impairment with best spectacle-corrected distance visual acuity (CDVA) of 20/63 or worse (decimal = 0.317 or less; logMAR greater than or equal to 0.50) in the treated eye(s).
7. - Patient CDVA records are available at baseline and at 12 month post-treatment.

Exclusion Criteria:

1. - Corneal disease or disorder in either eye.
2. - Increased intraocular pressure (above 20 mm Hg), glaucoma or history of glaucoma.
3. - Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable for retrospective observational study.

   -

Primary outcomes:
measure: CDVA
timeFrame: 12 months
Secondary outcomes:
measure: CNVA
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Bochner Eye Institute
state: Ontario
Study officials:
affiliation: Optimal Acuity Corporation
name: Michael Berry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04164654: A Mobile App to Address Student Loneliness
Official title: Using a Mobile App to Address Student Loneliness Among College Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: HopeLab Foundation
name: National Institute on Drug Abuse (NIDA)
First posted: 2019-11-15
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to assess the effects of a positive psychology and CBT-based skills intervention-delivered through a mobile app called Nod-on loneliness and other mental health and institutional satisfaction outcomes. The primary outcome is self-reported loneliness at 2 and 4-weeks post baseline.

Detailed description: This study is a pilot eight-week randomized controlled intervention. It employs a "waitlist" control strategy for the first 4 weeks of the study (considered to be the active study period).

Randomization will be to one of two conditions:

1. Experimental group: Immediate access to the Nod app
2. Waitlist control group: Participants will be granted access to the app four weeks after the experimental group

Assessments will occur at baseline, 2, 4, and 8 weeks follow up. Assessments will include measures of loneliness, and other mental health and institutional satisfaction measures listed in the secondary outcome measures section.

Eligibility criteria: Inclusion Criteria:

* Incoming college first years
* Live away from home without parents/guardians upon beginning college
* Read English
* Between 18 and 25 years of age
* Own a smartphone

Exclusion Criteria:

* Do not read English
* Under 18 years of age
* Over 25 years of age
* Do not own a smartphone

Primary outcomes:
measure: Condition differences in self-reported loneliness
timeFrame: 2-weeks post baseline
measure: Condition differences in self-reported loneliness
timeFrame: 4-weeks post baseline
Secondary outcomes:
measure: Depressive symptoms
timeFrame: 2 and 4 weeks post baseline
measure: Anxiety
timeFrame: 2 and 4 weeks post baseline
measure: Social Anxiety
timeFrame: 2 and 4 weeks post baseline
measure: Self-reported intention to remain enrolled at the University of Oregon in the next academic year
timeFrame: 2 and 4 weeks post baseline
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
References:
citation: Bruehlman-Senecal E, Hook CJ, Pfeifer JH, FitzGerald C, Davis B, Delucchi KL, Haritatos J, Ramo DE. Smartphone App to Address Loneliness Among College Students: Pilot Randomized Controlled Trial. JMIR Ment Health. 2020 Oct 20;7(10):e21496. doi: 10.2196/21496.
Clinical trial NCT05079854: Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis
Official title: Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Endophthalmitis
Trauma, Corneal
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Endophthalmitis is a severe inflammatory eye condition with profound impairment of vision, which can lead to irreversible visual loss and requires immediate treatment.

There is no way to completely prevent endophthalmitis, however, through prophylactic methods, it is possible to reduce its incidence. Currently, the only technique that has reached category II of evidence in reducing the risks of endophthalmitis is the use of 5% povidone-iodine eye drops, moments before surgery. In 2007, the European Society of Cataract and Refractive Surgery (ESCRS) released a large multicenter randomized clinical trial, with data on the reduction in the rates of endophthalmitis, using the intracameral antibiotic therapy technique of perioperative cefuroxime. However, much is discussed about the risks related to the technique, such as dilutional errors, contamination, anaphylaxis and cost-effectiveness, which still makes the conduct debatable.

The study evaluates the use of intracameral Moxifloxacin 0.5% (Vigamox®) as prophylaxis in cases of endophthalmitis after open ocular trauma;


Eligibility criteria: Inclusion Criteria:

* open globe trauma

Exclusion Criteria:

* endophthalmitis at the beginning

Primary outcomes:
measure: Endophthalmitis
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Dept of Ophthalmology - UNIFESP/Hospital São Paulo
state: SP
Study officials:
References: