louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00645892: Extension Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official title: Extension Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Extension Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis


Eligibility criteria: Inclusion Criteria:

* Subject participated and relapsed in prior PS study

Exclusion Criteria:

* Subject has other active skin diseases
* Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
* Poorly controlled medical conditions
* History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease.
* History of cancer or lymphoproliferative disease
* History of active TB or listeriosis, or persistent chronic or active infections
* Known to have immune deficiency or is immunocompromised
* Clinically significant abnormal laboratory test results
* Erythrodermic psoriasis or generalized pustular psoriasis

Primary outcomes:
measure: Psoriasis Area and Severity Index
timeFrame: Week 12
measure: Adverse Events
timeFrame: Throughout Study Participation
Secondary outcomes:
measure: Psoriasis Area and Severity Index
timeFrame: Week 12, Week 24
measure: Physician's Global Assessment
timeFrame: Week 12, Week 24
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01733992: A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease
Official title: A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Pharmacokinetics, Tolerability and Safety Study of R932348 Ophthalmic Solution in Patients With Mild to Moderate Keratoconjunctivitis Sicca
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Keratoconjunctivitis Sicca
Lead sponsor: Rigel Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-11-27
Enrollment: 36
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: The purpose of this study is to determine the safety, tolerability and pharmacokinetics of R348 eye drops in patients with dry eye disease.

Detailed description: This is a randomized, double-blind, placebo-controlled single and multiple ascending dose study to evaluate the ocular tolerability, safety, and pharmacokinetics of R348 administered in patients with mild to moderate keratoconjunctivitis sicca (KCS).

Eligibility criteria: Inclusion Criteria:

* Mild to moderate Keratoconjunctivitis Sicca.
* A corrected visual acuity in both eyes of 20/40 or better.
* An intraocular pressure of \< 21 mm Hg with a difference between eyes of \< 6 mm Hg.

Exclusion Criteria:

* History or evidence of ocular infection, inflammation, or conjunctivitis within 2 months prior to the first dosing day.
* History or evidence of blepharitis requiring the use of antibiotics or eye scrubs within 2 months prior to the first dosing day.
* History of herpes simplex keratitis at any time.
* Current ocular allergy symptoms.
* Recent use of eye medications such as steroids or cyclosporine
* Refractive eye surgery within 12 months of the first dosing day.
* Other eye surgeries within 4 months of the first dosing day.
* Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day.
* Receipt of any blood or blood products within 90 days prior to the first dosing day.
* Participation in any clinical study within 30 days prior to the first dosing day.
* History of disease, or currently have a significant illness or abnormal laboratory finding as determined by your study doctor.
* Positive for hepatitis B, hepatitis C or HIV.
* Smoked regularly within 12 months of first dosing day.
* History of substance abuse, drug addiction or alcoholism.

Primary outcomes:
measure: Change in corneal fluorescein staining
timeFrame: Baseline and Visits 4, 8 and 12
Secondary outcomes:
measure: Change in conjunctival lissamine green staining
timeFrame: Baseline and Visits 4, 8 and 12
Other outcomes:
measure: Change in Schirmer test
timeFrame: Baseline and Visits 4, 8 and 12
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: Andover Eye Associates
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04835792: Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers
Official title: Biomarker Study to Evaluate Participants With Previously Treated Lyme Disease in Comparison to Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lyme Disease
Lead sponsor: FlightPath Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously treated Lyme disease volunteers and healthy volunteers

Brief summary: Non-interventional study evaluating stool and blood samples collected from individuals previously treated with Lyme disease versus healthy volunteers


Eligibility criteria: Inclusion Criteria:

1. Males and females ≥18 years of age.
2. Able to read, understand, and provide signed informed consent.
3. Willing to provide blood and stool samples.
4. Able to communicate adequately and to comply with the requirements for the entire study.
5. Must be willing to discontinue antibiotics 2 weeks prior to sample collection.
6. If participating in the previously treated Lyme Disease arm, the participants must meet the following criteria: 1) Diagnosis of prior Lyme Disease supported by either an erythema migrans rash (either classic "bull's eye" or irregular) OR a CDC-positive Western blot, 2) previously treated with antibiotics for Lyme Disease, 3) remains ill six months or more after receiving preliminary treatment with antibiotics for Lyme disease (e.g., fatigue, musculoskeletal pain, or neurocognitive symptoms).
7. If participating in the healthy volunteer arm, the participants must meet the following criteria: 1) must not have had a Lyme Disease diagnosis, 2) in generally good health

Exclusion Criteria:

1. Unwilling or unable to comply with the protocol (e.g., scheduled visits, laboratory tests, other study procedures, and study restrictions).

Primary outcomes:
measure: • To evaluate and compare the microbiome of normal participants and participants with previously treated Lyme Disease
timeFrame: 30 days
measure: • To evaluate and compare the transcriptome of normal participants and participants with previously treated Lyme Disease
timeFrame: 30 days
measure: • To evaluate and compare the metabolome of normal participants and participants with previously treated Lyme Disease
timeFrame: 30 days
measure: • Evaluation of symptoms and prior medications/treatments of normal participants and participants with previously treated Lyme Disease
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Dr. Curtis Scribner
state: California
Study officials:
References:
Clinical trial NCT05156944: Effect of Physiotherapy in Patients Presenting to the Emergency Department After a Fall
Official title: Effect of Physiotherapy in Patients Presenting to the Emergency Department After a Fall. A Brief Intervention Focusing on Patient Reported Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Falling
Keywords: fall
Ground Level Fall" (GLF)
physiotherapy intervention
short International Falls efficacy scale (sFES-I)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 104
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this monocentric, block-randomized, controlled, open-label, parallel-group study is to assess whether patients presenting to the emergency department (ED) with a fall within the past 7 days would benefit from a physiotherapy intervention, as compared to patients without physiotherapy intervention at the time of ED presentation. Primary objective of this study is to assess "fear of falling" 7 days after ED presentation with versus without a physiotherapy intervention.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age ≥65
* History of falls within the last 7 days
* Presentation to the ED of the University Hospital Basel

Exclusion Criteria:

* Inpatient disposition after ED work-up
* Immobilizing fractures of the lower extremities
* Inability or contraindications to undergo the investigated intervention or follow the study procedures, e.g. due to certain neurological disorders (such as parkinsonism, hemiplegia, severe multiple sclerosis), language problems, psychological disorders, cognitive impairment
* Prior enrolment in this trial

Primary outcomes:
measure: Change in short International Falls efficacy scale (sFES-I)
timeFrame: At Day 0 and Day 7 ± 7 days
Secondary outcomes:
measure: Feasibility of the intervention
timeFrame: At Day 0
measure: Objective functional levels in the intervention group
timeFrame: At Day 0 and Day 7 ± 7 days
measure: Satisfaction with ED work-up
timeFrame: Day 7 ± 7 days
measure: Change in short International Falls efficacy scale (sFES-I)
timeFrame: At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
measure: Utilization of medical resources
timeFrame: Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
measure: Occurence of falls
timeFrame: Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Emergency Medicine, University Hospital Basel
Study officials:
affiliation: Department of Emergency Medicine, University Hospital Basel
name: Roland Bingisser, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00131144: Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
Official title: A Randomized, Controlled Study on the Efficacy and Safety of Octreotide Acetate in Microspheres in the Therapy of Patients With Moderately Severe or Severe Non-proliferate Diabetic Retinopathy (NPDR) or Low Risk Proliferative Diabetic Retinopathy (PDR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Retinopathy
Keywords: Diabetic retinopathy,Octreotide Acetate in Microspheres
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-17
Enrollment: 583
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The most common ocular disease in patients with diabetes, diabetic retinopathy, is present in approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening diabetic retinopathy. Although intensive control of blood glucose has been shown to reduce the development and progression of diabetic retinopathy, intensive control of glucose is usually not achieved in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Males and females with type 1 and type 2 diabetes mellitus
* Moderately severe or severe NPDR or mild PDR in at least one eye:

  * with an Early Treatment Diabetic Retinopathy Study (ETDRS) visual score of \> 35 letters; and
  * not previously treated with scatter photocoagulation.
* HbA1c \< 13% at study entry

Exclusion Criteria:

* Condition which could interfere with the assessment of retinopathy progression
* History of symptomatic gallstones without cholecystectomy
* Brittle diabetes or history of severe hypoglycemia unawareness
* Previous treatment with a somatostatin analogue

Primary outcomes:
measure: time to progression of diabetic retinopathy
timeFrame: throughout study
Secondary outcomes:
measure: time to development or progression of macular edema, and
timeFrame: Baseline through end of study
measure: time to moderate vision loss
timeFrame: Baseline through end of study
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: East Hanover
name: Novartis Customer Information
role: STUDY_CHAIR
References:
citation: Pivonello R, Muscogiuri G, Holder G, Paul M, Sarp S, Lesogor A, Jordaan P, Eisinger J, Colao A. Long-term safety of long-acting octreotide in patients with diabetic retinopathy: results of pooled data from 2 randomized, double-blind, placebo-controlled phase 3 studies. Endocrine. 2018 Apr;60(1):65-72. doi: 10.1007/s12020-017-1448-5. Epub 2017 Nov 7.
Clinical trial NCT00518544: Hemostatic Effect of Various Colloid Solutions
Official title: Hemostatic Effect of Various Colloid Solutions According to Blood Types
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laminectomy
Keywords: hydroxyethyl starch, blood type, coagulation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2007-08-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Individuals with type O blood have reduced factor VIII and von Willebrand factor levels compared to the non-O counterpart. Infusion of hydroxyethyl starch (HES) impairs coagulation and, in O blood type, apparent coagulopathy can develop after HES infusion. A newly market-released balanced HES (670/0.75) has physiologic pH and balanced electrolytes including calcium, which are beneficial to coagulation. Studies comparing balanced HES (670/0.75) with saline-based HES (130/0.4), previously known the least coagulopathic are rare. Therefore, we try to reveal the difference of coagulation, pH/electrolyte balance, and bleeding amount between the non-O and O blood types after infusion of these two newest HES.

Methods: Each 20 of non-O and type O ASA 1 or 2 patients scheduled for spinal surgery involving 2 or 3 spinal levels were enrolled. 20 ml/kg of saline-based HES (130/0.4) or balanced HES (670/0.75) was administered during operation. Blood loss, coagulation and metabolic profiles were checked at pre-infusion (T0), 5 min after infusion (T1), 4 hrs after infusion (T2) and 24 hrs after infusion (T4).


Eligibility criteria: Inclusion Criteria:

* Patients of ASA 1 or 2, and scheduled for posterior laminectomy and internal fixation at two or three spinal levels.

Exclusion Criteria:

* the presence of cardiovascular diseases, cerebral vascular disease, hepatic, pulmonary, or renal disease, hemoglobin \< 12 g/dl, platelet count \< 150,000 /ml, coagulopathy, taking medication likely to alter coagulation less than 2 weeks before the study, or an allergic reaction to HES

Primary outcomes:
measure: Blood loss, coagulation and metabolic profiles
timeFrame: pre-infusion, 5 min after infusion, 4 hrs after infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
affiliation: Samsung Medical Center
name: Hyun Joo Ahn, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06178744: A Study of AI in Cardiac Transplant in Echocardiographic Analysis (ORACLE)
Official title: Outcome Reflection for Immune Mediated Rejection by Utilizing Artificial Intelligence in Cardiac Transplant Patients Through Early and Late Echocardiographic Analysis (ORACLE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Transplant Rejection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-cardiac transplantation subjects, presenting to the cardiac catheterization laboratories at Mayo Clinic in Rochester, MN for routine surveillance biopsies or for diagnostic biopsies in the setting of clinical concern including rejection and graft dysfunction will be enrolled.

Brief summary: The purpose of this research is to detect episodes of rejection versus non-rejection after cardiac transplant and the diagnostic accuracy of an Artificial Intelligence (AI) algorithm using the data from an ECG (electrocardiogram) and Cardiac Ultrasound (Echocardiogram and/or point of care ultrasound).


Eligibility criteria: Inclusion Criteria:

* Patients undergoing post-cardiac transplant endomyocardial biopsy, and the ability to provide informed consent and a consent for the study.

Exclusion Criteria:

* Refusal of study participation

Primary outcomes:
measure: Number of episodes identified by the Artificial Intelligence (AI) algorithm as 1R or greater acute cellular rejection, grade 1 or greater antibody mediated rejection, reduction in LVEF to <50%, or a drop in LVEF >5%
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Atta Behfar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05660044: Human Factors Study of Ultrasound Navigation Software for Cardiac Imaging
Official title: Human Factors Validation Study of Artificial Intelligence Ultrasound Navigation Software for Cardiac Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Lead sponsor: UltraSight
Sponsor class: INDUSTRY
First posted: 2022-12-21
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 28-34 study participants will be recruited to meet at least one of the following professions:

* Attending Physicians and/or Medical Residents
* Registered Nurses (RNs), Nurse Practitioners (NPs) and Physician Assistants (PAs)
* Medical assistants (CMAs)

Brief summary: The Product is a machine learning software, that utilizes AI to provide real-time guidance to acquire diagnostic-quality ultrasound views of the heart.

Detailed description: Participants are healthcare professionals, who are not performing echocardiography on a routine basis. Participants attend a short training session to learn the software, then have a memory-decay period, followed by an individual simulated-use scanning session, lasting up to 60 minutes with a Moderator at the heart institute.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* Novice users or medical professionals who do not perform echocardiographs as part of their routine job responsibilities.
* Have the capacity to understand study risks and consent to be in the study
* Be available and willing to participate in the study
* Not be employed by the Sponsor or another medical device or pharmaceutical company

Exclusion Criteria:

-

Primary outcomes:
measure: Usability of UltraSight AI guidance software
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba medical center
Study officials:
affiliation: UltraSight
name: Danny Spiegelstein, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05337644: Indocyanine Green Test for Evaluation of Perfusion of Staple Line of the Stomach During Laparoscopic Sleeve Gastrectomy
Official title: Leak After Sleeve Gastrectomy With Positive Intraoperative Indocyanine Green Test: Avoidable Scenario?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Diabete Type 2
Cardiac Disease
Vascular Diseases
Keywords: laparoscopic Sleeve gastrectomy
Bariatric Surgery
Indocyanine greene test
gastric fistula
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese patients with BMI \>40 kg/m2 underwent laparoscopic Sleeve gastrectomy

Brief summary: The investigators present the case of a 40-year-old female underwent laparoscopic sleeve gastrectomy. Intraoperative indocyanine green test was performed


Eligibility criteria: Inclusion Criteria:

* BMI \>40 kg/m2

Exclusion Criteria:

* Non-obese patients

Primary outcomes:
measure: Positive Intraoperative Indocyanine green test
timeFrame: from 20 January 2022 to 20 January 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: University of Foggia
Study officials:
affiliation: University of Foggia
name: Antonio Ambrosi
role: STUDY_CHAIR
References:
citation: Pavone G, Tartaglia N, Pacilli M, Maddalena F, Petruzzelli F, Ambrosi A. Leak after sleeve gastrectomy with positive intraoperative indocyanine green test: Avoidable scenario? Int J Surg Case Rep. 2022 Jun;95:107168. doi: 10.1016/j.ijscr.2022.107168. Epub 2022 May 6.
Clinical trial NCT01453244: Pharmacogenomic Research in Korean Patients With Hepatitis C
Official title: Pharmacogenomic Research for Prediction of Drug Response in Korean Patients With Hepatitis C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Keywords: Chronic hepatitis C
Pharmacogenomics
IL28B
ITPA
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2011-10-17
Enrollment: 373
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Korean patients with chronic hepatitis C

Brief summary: The aim of this study is to investigate the relationships between drug response and the host genetic factors, viral factors and clinical factors in chronic hepatitis C patients (HCV). And thus, the investigators are trying to develop the pharmacogenomic guideline in the Korean patients with HCV.


Eligibility criteria: Inclusion Criteria:

* Hepatitis C virus infected patients

Exclusion Criteria:

* Patients who infected Hepatitis B virus or Human immunodeficiency virus
* HCV infected patients previously treated with antiviral drugs
* Patients had a history of autoimmune hemolytic anemia

Primary outcomes:
measure: Sustained virological response (SVR)
timeFrame: 24 weeks after the end of treatment
Secondary outcomes:
measure: Anemia
timeFrame: 4 weeks after start of treatment
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University
Study officials:
affiliation: Inje University
name: Jae-Gook Shin, M.D, phD
role: PRINCIPAL_INVESTIGATOR
References: