louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06009029: SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study)
Official title: A Multicenter, Single-arm, Prospective Study of SBRT Combined With Zimberelimab (GLS-010) in Patients With Locally Advanced Pancreatic Cancer (SPARK-1 Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Locally Advanced Pancreatic Cancer
Keywords: Locally Advanced Pancreatic Cancer
SBRT
Zimberelimab
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is designed to investigate the efficacy and safety of patients with locally advanced pancreatic cancer by SBRT combined with Zimberelimab(GLS-010).

Detailed description: This a prospective, single-arm, multicenter study evaluating the efficacy and safety of stereotactic radiotherapy (SBRT) and Zimberelimab(GLS-010) in patients with pancreatic cancer. The primary endpoint is OS, and the secondary are PFS, ORR,DCR and adverse events.

Eligibility criteria: Inclusion Criteria:

* 18-75 years old.
* Locally advanced pancreatic cancer confirmed histologically and defined according to the NCCN Pancreatic Cancer Guidelines v1.2022 as unresectable or surgically declined.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* The expected survival ≥ 3 months.
* At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
* Patient must have adequate organ function defined by the study-specified laboratory tests.

Exclusion Criteria:

* Tumor invasion of the gastrointestinal tract, specifically pancreatic tumor or lymph node metastasis invading the gastrointestinal parenchyma.
* Woman who are pregnant or breastfeeding.
* Has a known additional malignancy within the past 5 years, except for cured skin cancer and cervical carcinoma in situ.
* Patients who have received prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
* Contraindications to immunotherapy.
* Other conditions that investigator decides not suitable for the trial.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 2 years
measure: Objective response rate (ORR)
timeFrame: 2 years
measure: Disease Control Rate (DCR)
timeFrame: 2 years
measure: Adverse Events
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Junjie Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01009229: A Reduced 11-b-HSD Activity, a Novel Mechanism of Salt Sensitivity and Hypertension After Renal Allograft Donation?
Official title: A Reduced 11 Beta Hydroxysteroid Dehydrogenase 2 (11 Beta HSD2) Activity, a Novel Mechanism of Salt Sensitivity and Hypertension After Renal Allograft Donation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Renal Transplantation
Living Donors
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Consecutive living-kidney donor candidates (n=100) will be recruited after being accepted for donation according to official guidelines. An assessment of salt sensitivity, 11 beta HSD activity, 24 hour blood pressure, urine collection and physical exam will be performed prior nephrectomy and 14, 52, 156, 208 days post-nephrectomy.

Detailed description: Consecutive living-kidney donor candidates (n=100) will be recruited after being accepted for donation. The assessment of salt sensitivity, 11 beta HSD activity, 24 hour blood pressure, urine collection and physical exam will be performed prior nephrectomy and 14, 52, 156, 208 days post-nephrectomy.

Eligibility criteria: Inclusion Criteria:

* acceptance for living kidney donation

Exclusion Criteria:

* withdrawal of consent

Primary outcomes:
measure: Salt sensitivity, arterial hypertension
timeFrame: day 0, 14, 52, 156, 208, yearly
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of nephrology and hypertension, Universitiy of Bern
Study officials:
affiliation: University of Berne
name: Felix J Frey, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06699329: A Study of Enlicitide Decanoate (MK-0616) and Semaglutide in Healthy Adult Participants (MK-0616-023)
Official title: A Clinical Study to Evaluate the Effect of MK-0616 and Semaglutide on Their Respective Pharmacokinetics in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-11-21
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to learn what happens in a person's body over time when they take enlicitide decanoate and semaglutide alone or at the same time. Enlicitide decanoate is a new medicine that lowers the amount of cholesterol in a person's blood. Semaglutide is a drug used to treat type 2 diabetes.

Researchers want to learn what happens to the amount of semaglutide and enlicitide decanoate in a person's blood when each drug is taken alone and when they are taken together.


Eligibility criteria: Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2
* Medically healthy with no clinically significant medical history

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery
* History of cancer

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate
timeFrame: At designated timepoints (up to 24 hours postdose)
measure: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Semaglutide
timeFrame: At designated timepoints (up to 24 hours postdose)
measure: Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate
timeFrame: At designated timepoints (up to approximately 2 weeks postdose)
measure: Maximum Plasma Concentration (Cmax) of Semaglutide
timeFrame: At designated timepoints (up to approximately 2 weeks postdose)
measure: Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate
timeFrame: At designated timepoints (up to approximately 2 weeks postdose)
measure: Time to Maximum Plasma Concentration (Tmax) of Semaglutide
timeFrame: At designated timepoints (up to approximately 2 weeks postdose)
Secondary outcomes:
measure: Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)
timeFrame: Up to approximately 12 weeks
measure: Number of Participants Who Discontinue Study Due to a TEAE
timeFrame: Up to approximately 12 weeks
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion (Site 0001)
state: Nebraska
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01128829: Sugar-replacement Sweeteners, and Blood Sugar Control
Official title: Regulation of Incretin Release by Non-nutritive Sweeteners in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
diabetes
artificial sweeteners
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2010-05-24
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Several sugar-replacement sweeteners are currently on the market, including saccharine (ex. Sweet'N Low), aspartame (ex. Equal), and sucralose (ex. Splenda). The purpose of this study is to examine wether non caloric sweeteners affects how well the body works to control blood sugar. The study includes detailed blood sugar testing after drinking liquids that may contain sucralose. The investigators hypothesize that drinking liquids with sucralose will effect the amounts of specific appetite-affecting substances naturally produced by the body.


Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) over 30.
* Homeostasis model assessment of insulin resistance (HOMA-IR) \< or = 2.6

Exclusion Criteria:

* smoking or smoked within last six months
* pregnant or breastfeeding
* have malabsorptive syndromes
* intestinal inflammatory disease
* diabetes
* liver or kidney disease
* fructose intolerance
* consuming more than one can of diet beverage or one spoonful of non-nutritive sweeteners (e.g. sucralose, aspartame, or saccharine) a week.
* taking any medication that might affect metabolism or taste.

Primary outcomes:
measure: The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Marta Y Pepino de Gruev, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pepino MY, Tiemann CD, Patterson BW, Wice BM, Klein S. Sucralose affects glycemic and hormonal responses to an oral glucose load. Diabetes Care. 2013 Sep;36(9):2530-5. doi: 10.2337/dc12-2221. Epub 2013 Apr 30.
Clinical trial NCT02779829: 18432-Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose(MPPD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-05-20
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment DArkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04163029: Oral Care Study of Postoperative Infections
Official title: Analysis of the Impact on the Incidence of Postoperative Infections (at the Surgical Site, Flap and Lung) and on the Length of Stay of Oral Care Before Surgery on the ENT Sphere With Flap Reconstruction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer, Mouth
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients operated on for transmandibulary buccopharyngectomy with recognition, free flap struction

Brief summary: Reduce the incidence of post-operative infections after ENT surgery and flap reconstruction by performing preoperative oral and dental care

Detailed description: Reduce the incidence of post-operative infections after ENT surgery and flap reconstruction by performing preoperative oral and dental care

Eligibility criteria: Inclusion Criteria:

* ENT surgery with free flap reconstruction

Exclusion Criteria:

* Allergy to chlorhexidine

Primary outcomes:
measure: incidence of postoperative infections
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University of Liege, University Hospital
Study officials:
affiliation: Centre Hospitalier Universitaire de Liege
name: Benjamin Javillier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00911729: Content Validation of Quality of Life and Symptom Questionnaires for Pheochromocytoma and Paraganglioma
Official title: Content Validation of the EORTC QLQ-C30 Version 3.0, and NIH Quality of Life and Symptoms Questionnaire for Pheochromocytoma and Paraganglioma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pheochromocytoma
Paraganglioma
Keywords: paraganglioma
pheochromocytoma
Lead sponsor: Molecular Insight Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a documented (medical record) diagnosis of either pheochromocytoma or paraganglioma with active symptoms or who are within 60 days of curative therapy

Brief summary: The purpose of this qualitative study is to evaluate the clarity and comprehensiveness of two disease-specific questionnaires, and to evaluate how effective these questionnaires are at assessing the quality of life and symptoms of patients with pheochromocytoma or paraganglioma.


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent and be willing to comply with protocol requirements
* Participant is aged ≥ 18
* Have a documented (medical record) diagnosis of either pheochromocytoma or paraganglioma with active symptoms or within 60 days of curative therapy

Exclusion Criteria:

Patient is currently asymptomatic from pheochromocytoma/paraganglioma diagnosis or duration \> 60 days from curative therapy

* Participant has a clinically significant disorder, including alcohol or drug abuse, which may interfere with study participation or which may affect the outcome of the study as judged by the investigator.
* Participant has a mental disability or significant mental illness, legal incapacity or limited legal capacity or any other lack of fitness, in the investigator's opinion, to preclude the subject's participation in or ability to complete the study.
* Participant is currently too unwell to take part in the study.

Primary outcomes:
measure: The main objective of this study is to evaluate content validity of the NIH Quality of Life and Symptoms Questionnaire for Pheochromocytoma and Paraganglioma and EORTC-QLQ-C30 in patients with pheochromocytoma or paraganglioma.
timeFrame: Single Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Oxford Outcomes- Nationwide Recruitment within the US
state: Maryland
Study officials:
affiliation: Oxford Outcomes
name: Emuella M Flood, BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02687529: Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection
Official title: Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: Tuberculosis
TB
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
First posted: 2016-02-22
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have either a low risk or known risk for TB exposure.

Brief summary: To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.


Eligibility criteria: Low Risk and Known Risk Cohorts

Inclusion Criteria:

* Compensated and uncompensated members (current or future) of the Department of Veterans Affairs with no identified symptoms of active TB disease
* Age greater than 18 years or less than 80 years.

Exclusion Criteria:

* Currently taking therapy for active tuberculosis or latent TB infection for more than 14 days.

Primary outcomes:
measure: Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites
timeFrame: 1 day (At time of enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System (VAPAHCS)
state: California
Study officials:
References:
citation: QuantiFERON-TB Gold Package Insert (DOC. No. US05990301L). March 2013. QIAGEN Inc.
citation: Shams H, Klucar P, Weis SE, Lalvani A, Moonan PK, Safi H, Wizel B, Ewer K, Nepom GT, Lewinsohn DM, Andersen P, Barnes PF. Characterization of a Mycobacterium tuberculosis peptide that is recognized by human CD4+ and CD8+ T cells in the context of multiple HLA alleles. J Immunol. 2004 Aug 1;173(3):1966-77. doi: 10.4049/jimmunol.173.3.1966.
citation: Lewinsohn DA, Winata E, Swarbrick GM, Tanner KE, Cook MS, Null MD, Cansler ME, Sette A, Sidney J, Lewinsohn DM. Immunodominant tuberculosis CD8 antigens preferentially restricted by HLA-B. PLoS Pathog. 2007 Sep 21;3(9):1240-9. doi: 10.1371/journal.ppat.0030127.
Clinical trial NCT01495429: Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurological Intensive Care
Official title: A Phase III Study of Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurological Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thrombosis
Keywords: catheter related large vein thrombosis
upper extremity deep venous thrombosis
central venous catheters
upper extremity catheter related large vein thrombosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2011-12-20
Enrollment: 80
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: The investigators aim to compare the complications between centrally and peripherally inserted central venous catheters in neurological intensive care unit patients. The study hypothesis is that peripherally inserted catheters will have more cumulative complications due to venous thrombosis.


Eligibility criteria: Inclusion Criteria:

* all patients age \> 18, admitted to the neurological ICU who are require a de novo central venous catheter as standard of care and in which a double lumen 5f PICC or CICVC (triple lumen, 7f) are acceptable for the indication.
* the patients must be expected to survive and need a central venous catheter for at least 7 days.

Exclusion Criteria:

* prisoner
* age \< 18
* expected to die or have care withdrawn prior to ICU day 7
* requiring an emergent central venous catheter
* suspected bacteremia
* recent central venous catheter within the last 30 days
* patients who are not a candidate for bedside placement of either a CICVC or PICC line
* patients with renal insufficiency with creatinine level greater than 3.0 mg/dL (265.2 m mol/L) or who were undergoing hemodialysis
* patients requiring a central venous catheter for prolonged antibiotic therapy\\
* patient who the treating clinician feels clearly needs one particular type of catheter over the other

Primary outcomes:
measure: The composite of death or catheter related large vein thrombosis
timeFrame: 15 days
Secondary outcomes:
measure: Cumulative catheter related complications until discharge
timeFrame: 30 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jeffrey J Fletcher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02822729: A Long-term Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With OAG or OH: RENGE Study
Official title: A Long-term Open-label Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension : RENGE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open Angle Glaucoma or Ocular Hypertension
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-04
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to evaluate the long-term safety and intraocular pressure-lowering efficacy of DE-117 ophthalmic solution monotherapy and concomitant use of DE-117 ophthalmic solution with timolol ophthalmic solution 0.5% in patients with open angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Patients with open angle glaucoma or ocular hypertension

Exclusion Criteria:

* Patients at risk of progression of visual field loss
* Patients with severe visual field defect
* Patients with any diseases that preclude participation in this study for safety reasons

Primary outcomes:
measure: Evaluation of adverse events
timeFrame: Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
citation: Aihara M, Lu F, Kawata H, Iwata A, Odani-Kawabata N. Twelve-month efficacy and safety of omidenepag isopropyl, a selective EP2 agonist, in open-angle glaucoma and ocular hypertension: the RENGE study. Jpn J Ophthalmol. 2021 Nov;65(6):810-819. doi: 10.1007/s10384-021-00868-y. Epub 2021 Sep 8.