louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04089072: Methylene Blue as a Third-line Vasopressor in Septic Shock
Official title: Methylene Blue as a Third-line Vasopressor in Septic Shock to Maintain Hemodynamics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Septic Shock
Keywords: Methylene Blue
Vasopressors
Septic Shock
Provay Blue®
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: Provepharm Life Solutions
First posted: 2019-09-13
Enrollment: 250
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: A randomized, prospective study comparing ProvayBlue® to standard care with multiple sympathomimetic vasopressors.

Detailed description: The study will be an un-blinded, Phase 2, randomized, 1:1, prospective trial comparing patients in septic shock receiving norepinephrine and vasopressin followed by phenylephrine versus ProvayBlue® as the third-line vasopressor. The third line vasopressor will be compared at 1 hour to see if it affects the patient's mean arterial blood pressure (MAP).

Eligibility criteria: Inclusion Criteria:

1. Meets Sepsis-3 Criteria (Suspected source of infection plus any 2 criteria of the qSOFA)

2 .Septic Shock (any patient requiring vasopressor therapy to maintain MAP \>65 mmHg or any patient with serum lactate \>2 mmol/dL even in the absence of hypovolemia ).

3) Greater than 18 years old

4 ) ICU Admission

Exclusion Criteria:

Inability to obtain informed consent from an appropriate surrogate decision maker.

Also:

1. Children less than 18 years old
2. Pregnant women or positive urinary pregnancy test in reproductive-aged women
3. Prisoners
4. Evolving myocardial infarction or known cardiomyopathy with documented EF\<35%
5. Known grade 3 diastolic dysfunction document by echocardiogram
6. Known hypersensitivity to thiazine dyes
7. Pulmonary hypertension that is currently requiring vasodilator therapy
8. Concurrent form of shock present or suspected: Obstructive, Neurogenic, Hemorrhagic
9. Known documented history of G6PD deficiency or favism
10. Active prior to admission medication prescription for a SSRI or SNRI , systemic heparin anticoagulation or other medications listed above (under Study Agent). These medications will be listed in the printed enrollment form.
11. Severe renal failure is a contraindication to use of ProvayBlue®.

Primary outcomes:
measure: Change in mean arterial pressure
timeFrame: One hour and 24 hours after dose
Secondary outcomes:
measure: Incidence of acute kidney injury requiring dialysis
timeFrame: through time of patient discharge, an average of 8 days after admission
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Frank Biscardi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04252872: Pharmacokinetics of HCP1401 and Co-administration of HCP0605, HGP1405 in Healthy Male Volunteers
Official title: A Randomized, Open-label, Oral Single Dose, Two-way Crossover Clinical Trial to Compare the Pharmacokinetics and Safety/Tolerability After Administration of HCP1401 and Co-administration of HCP0605 and HGP1405 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 64
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, oral single dose, two-way crossover clinical trial to compare the pharmacokinetics and safety/tolerability after administration of HCP1401 and co-administration of HCP0605 and HGP1405 in healthy male volunteers

Detailed description: The purpose of this study is to investigate the pharmacokinetics and safety/tolerability after administration of HCP1401 and co-administration of HCP0605, HGP1405 in healthy male volunteers

Eligibility criteria: Inclusion Criteria:

1. Healthy male volunteer, age 19\~45 years
2. Weight is not less than 55kg, no more than 90kg and Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Subjects who judged ineligible by the investigator.

Primary outcomes:
measure: AUClast
timeFrame: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose
measure: Cmax
timeFrame: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose
Secondary outcomes:
measure: AUCinf
timeFrame: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose
measure: Tmax
timeFrame: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose
measure: T1/2
timeFrame: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose
measure: Cl/F
timeFrame: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose
measure: Vz/F
timeFrame: pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT03974672: A T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery
Official title: A Retrospective Study Using a T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Diverticulitis
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after elective or emergent gastrointestinal surgery with a leak in their GI anastomosis

Brief summary: Assessing the use of a T drain approach for an anastomotic leak after gastrointestinal surgery. The study's aim is to retrospectively assess the safety and benefits of this approach.

Detailed description: Assessing the use of a T drain approach for an anastomotic leak after gastrointestinal surgery. The T drain approach is inserting a latex t tube drain into the leak site of the anastomosed bowel and diverting the fecal matter. The study's aim is to retrospectively assess the safety and benefits of this approach.

Eligibility criteria: Inclusion Criteria:

* Patients after elective or emergent gastrointestinal surgery with a leak in their GI anastomosis

Exclusion Criteria:

* under 18 years of age
* Pregnancy

Primary outcomes:
measure: Measuring severity of complications with the Dindo Clavien complications scale
timeFrame: 30 day post operation
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center Israel
name: Yaron Rudnicki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03297372: Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.
Official title: Clinical Study to Investigate Visual Performance of Hydrophobic Monofocal IOL: MicroPure 1.2.3.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lens Opacities
Keywords: Intraocular lens
monofocal
cataract
PhysIOL
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-29
Enrollment: 121
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The clinical investigation is a post-market clinical follow up study whereby patients undergoing routine cataract surgery will have monolateral implantation of a commercially available, CE approved monofocal intraocular lens MicroPure 1.2.3. (PhysIOL, Liège, Belgium).

Detailed description: The examinations consist of visual acuity data, contrast sensitivity exams, slitlamp examinations and posterior capsule opacification (PCO) grading.

Follow up will be up to 24 months postoperative.

Eligibility criteria: Inclusion Criteria:

* Cataractous eyes with no comorbidity
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent

Exclusion Criteria:

* Irregular astigmatism
* Age of patient \< 45 years
* Regular corneal astigmatism \> 0.75 D on study eye as measured by an automatic keratometer (regularity determined by the topography of the keratometry)
* Difficulty for cooperation (distance from their home, general health condition)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
* Complicated surgery

Primary outcomes:
measure: monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions
timeFrame: 6 months postoperative
Secondary outcomes:
measure: Posterior capsule opacification (PCO) grading
timeFrame: 2 years postoperative
measure: Uncorrected Distance Visual acuity (UDVA)
timeFrame: 6 months postoperative
measure: Contrast Sensitivity
timeFrame: 6 months postoperative
measure: Glistening assessment
timeFrame: 2 years postoperative
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico
city: Rome
country: Italy
facility: Fondazione GB Bietti - IRCCS
Study officials:
affiliation: Fondazione GB Bietti - IRCCS
name: Domenico Schiano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03778372: Methadone for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery
Official title: Methadone for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergence Delirium
Strabismus
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 55
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children, aged 0-18 years, undergoing outpatient strabismus surgery under general anesthesia

Brief summary: Strabismus surgery for children is a very common procedure, with a high incidence of emergence delirium in the recovery room. Pain is often implicated in delirium. The primary aim of this study is to determine whether a single, intraoperative dose of methadone for outpatient ambulatory pediatric strabismus surgery reduces postoperative delirium.


Eligibility criteria: Inclusion Criteria:

* ASA I/II children undergoing outpatient strabismus surgery

Exclusion Criteria:

* anything not meeting the above

Primary outcomes:
measure: Pediatric Anesthesia Emergence Delirium scale scores
timeFrame: measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours.
Secondary outcomes:
measure: wong-baker or numeric pain scores, depending on age
timeFrame: measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours.
measure: discharge time
timeFrame: 24 hours
Other outcomes:
Locations:
city: Jefferson
country: United States
facility: Ochsner Main Campus
state: Louisiana
Study officials:
References:
citation: Komen H, Brunt LM, Deych E, Blood J, Kharasch ED. Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study. Anesth Analg. 2019 Apr;128(4):802-810. doi: 10.1213/ANE.0000000000003464.
citation: Ward RM, Drover DR, Hammer GB, Stemland CJ, Kern S, Tristani-Firouzi M, Lugo RA, Satterfield K, Anderson BJ. The pharmacokinetics of methadone and its metabolites in neonates, infants, and children. Paediatr Anaesth. 2014 Jun;24(6):591-601. doi: 10.1111/pan.12385. Epub 2014 Mar 26.
Clinical trial NCT00125372: Study of Tarceva and Targretin in Stage I-II Lung Cancer
Official title: A Clinical and Pharmacologic Study of the Combination of Erlotinib and Bexarotene in Resectable Clinical Stage I-II Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Non-small-cell Lung
Keywords: tarceva
targretin
non-small cell lung cancer
carcinoma, non-small cell lung cancer
nsclc
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Ligand Pharmaceuticals
name: Genentech, Inc.
First posted: 2005-08-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn the effects on lung cancer of 2 new drugs, Tarceva and Targretin, given in combination before surgical removal of the tumor. Tarceva is approved by the Food and Drug Administration (FDA) for lung cancer. Targretin is approved for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.

Detailed description: Erlotinib 150mg and bexarotene 400mg/m2 will be administered orally for 7-9 days prior to thoracotomy. Plasma samples will be collected on the day before surgery and along with tissue samples on the day of the thoracotomy. Analyses will be done on the resected specimen and it will be compared to the pre-study diagnostic specimen.

Eligibility criteria: Inclusion Criteria:

* Resectable stage I or II non-small-cell lung cancer
* Prior tissue biopsy (not cytology) available for research analysis
* Adequate hepatic and renal function

Exclusion Criteria:

* Prior chemotherapy or radiotherapy

Primary outcomes:
measure: Number of Participants With Change in Expression Level of EGFR.
timeFrame: Baseline and 9 days
measure: Number of Participants With Change in Expression Level of Cyclin D1
timeFrame: Baseline and 9 days
measure: Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR)
timeFrame: Baseline and 9 days
Secondary outcomes:
measure: Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels
timeFrame: At 9 days
measure: Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response
timeFrame: Baseline and 9 days
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center
state: New Hampshire
Study officials:
affiliation: Norris Cotton Cancer Center
name: Konstantin H Dragnev, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03195972: Observational Study to Assess Adherence Oral Anticancer Therapies
Official title: Observational Study to Assess Adherence of Oral Anticancer Therapies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adherence, Patient
Keywords: Adherence, Patient, oncology, oral therapy
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with cancer treated with oral therapy (targeted therapy or chemotherapy) excluding hormone therapy.

Brief summary: Oral anticancer treatments are increasingly numerous. They represent an additional alternative in the therapeutic arsenal of the clinician, and appear to satisfy patients who prefer this route of administration over intravenous treatment. The objective of oral therapies is twofold: to remove the constraints and risks associated with infusions and to allow the patient to follow his treatment at home.

However, they have significant adverse effects that may affect patients, who are sometimes at a disadvantage compared to how they are treated, and potentially lead to non-compliance with the consequences.

This study will identify the factors associated with non-adherence and determine the impact of this non-adherence in terms of treatment efficacy and tolerance.

The aim of this routine care study is to evaluate the adherence to oral anticancer therapies during 3 months.

Detailed description: Primary objective

- To evaluate adherence to oral anti-cancer therapies at 3 months

Secondary objectives

* To evaluate the adherence to 3 months according to the age of the patients (less than 75 years versus 75 years and more)
* Evaluate compliance at 1 and 2 months
* Evaluate toxicity at 1, 2 and 3 months according to compliance according to criteria CTCAE 4.03.
* Evaluate response to treatment at 3 months based on adherence
* Evaluate the factors associated with adherence and describe the reasons for non-adherence.

Eligibility criteria: Inclusion Criteria:

* Age\> 18 years
* Cancer proved histologically.
* Patient receiving an initial prescription for oral anticancer therapy, excluding hormone therapy
* Illness measurable or assessable by imaging
* Patient affiliated to a social security scheme
* Patient having been informed of the study
* Non-opposition of the patient

Exclusion Criteria:

* Contraindication to oral treatment
* Patient's refusal
* Patient under tutelage, curatorship or safeguard of justice
* Psychiatric illness and / or condition of the patient compromising understanding of information or conduct of the study

Primary outcomes:
measure: Compliance with treatment
timeFrame: 3 months
Secondary outcomes:
measure: Toxicity
timeFrame: 3 months
measure: Response to treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: CGFL
Study officials:
References:
Clinical trial NCT01674972: Glucose-induced Glucagon-like Peptide 1 (GLP-1) Secretion in NAFLD Patients Compared to Healthy Controls
Official title: Glucose-induced Glucagon-like Peptide 1 (GLP-1) Secretion in NAFLD Patients Compared to Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Alcoholic Fatty Liver Disease
Non Alcoholic Steatohepatitis
Keywords: NAFLD
NASH
GLP-1
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2012-08-29
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with biopsy proven NAFLD and NASH will be recruited from the Hepatology Outpatient Clinic, Division of Gastroenterology and Hepatology, University Hospital Basel.

Healthy control subjects will be matched to NAFLD and NASH patients.

Brief summary: The incretin effect is impaired in patients with type 2 diabetes mellitus (T2DM), thus GLP-1 receptor agonists are used for the treatment of T2DM. Insulin resistance is a pathophysiologic hallmark of non-alcoholic fatty liver disease (NAFLD). The incretin effect in patients with NAFLD has not been studied. The aim of this study is to quantify GLP-1 secretion in response to oral glucose tolerance test (oGTT) in patients with NAFLD compared to healthy controls. The results of this study will expand the knowledge of the pathophysiology of NAFLD and serve as a rational for potential future treatment strategies.

Detailed description: Primary endpoint: GLP-1 response to oral glucose Secondary endpoints: glucose and insulin responses to oral glucose challenge

Eligibility criteria: Inclusion Criteria:

* Biopsy proven NAFLD or NASH

Exclusion Criteria:

* additional concomitants liver disease
* T2DM
* alcohol consumption \>40g/d for male subjects and \>20g/d for female subjects

Primary outcomes:
measure: Glucagon-like Peptide 1 (GLP-1) secretion in response to oGTT
timeFrame: 0, 15, 30, 60, 90, 120 min. after glucose administration
Secondary outcomes:
measure: Insulin secretion and glucose curves in response to oGTT
timeFrame: 0, 15, 30, 60, 90, 120 min. after glucose administration
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Division of Gastroenterology and Hepatology
Study officials:
affiliation: University Hospital Basel, Division of Gastroenterology and Hepatology
name: Christoph Beglinger, MD
role: PRINCIPAL_INVESTIGATOR
References: