louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01960712: The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.
Official title: The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bile Leakage
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Jansson, Anders, M.D.
First posted: 2013-10-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bile leakage after liver transection is treated by external drainage. The question addressed is whether downstream control by transpapillary stent insertion into distal bile duct can enhance healing.

Detailed description: All patients who present with clinically significant bile leakage after liver resection at postoperative day two or longer are offered the opportunity to become randomized to either continuous external drainage or the addition of transpapillary stent.

Eligibility criteria: Inclusion Criteria:

* Liver resection including at least two liver segments.

Exclusion Criteria:

* Hepatobiliary digestive anastomosis.

Primary outcomes:
measure: Number of days of bile leakage from the abdominal cavity
timeFrame: From intervention until day discharge from hospital
Secondary outcomes:
measure: General complications rates. Postoperative hospital stay
timeFrame: From intervention until day of discharge from hospital
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Lars Lundell, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04599712: Pre-Approval Access With Amivantamab (JNJ-61186372) in Participants With Metastatic Non-Small Cell Lung Cancer
Official title: Pre-Approval Access With Amivantamab in Patients With Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations Who Have Failed Platinum-Based Chemotherapy
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Metastatic Non-Small Cell Lung Cancer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-10-23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this expanded access program (EAP) is to provide amivantamab for the treatment of participants with metastatic non-small cell lung cancer who have epidermal growth factor receptor exon 20 insertion mutations, and whose disease has progressed during or after current standard of care platinum-based chemotherapy. This intermediate EAP may be considered for individuals with serious/life-threatening diseases or conditions, where there are no alternative treatments or where individuals have progressed following standard of care.


Eligibility criteria: Inclusion Criteria:

* Has histologically or cytologically confirmed unresectable or metastatic non-small cell lung (NSCLC) cancer with an epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins), not amenable to curative therapy
* Has completed prior treatment with platinum-based chemotherapy. In the case of platinum ineligible participants, the participant may qualify if previously treated with an alternative treatment (example, an investigational or approved EGFR Exon 20 targeted tyrosine kinase inhibitor \[TKI\], or see guidelines such as those from national comprehensive cancer network \[NCCN\] or European society for medical oncology \[ESMO\] for alternative non-platinum-based treatments)
* Life expectancy is projected to be greater than or equal to (\>=) 3 months with adequate hepatic, renal, pulmonary and cardiac function (physician assessed)

Exclusion Criteria:

* Has medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis requiring treatment with prolonged steroids or other immune suppressive agents within the last 3 months
* Has leptomeningeal disease that is active or symptomatic
* Symptomatic, unstable or untreated brain metastases (need to be resolved prior to participating in the program)
* Known allergies, hypersensitivity, or intolerance to amivantamab or its excipients or to other monoclonal antibodies
* Is pregnant or breastfeeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT01789112: Acute Effects of a Non Excitatory Cardial Stimulation
Official title: Acute Neurotrophic Effects of a Non Excitatory Cardial Stimulation by Optimizer III System in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CCM Implantation
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Electric stimulation by cardial contractility modulation (CCM)to improve contractility and physical capacity


Eligibility criteria: Inclusion Criteria:

* planned CCM Implantation
* systolic left ventricular dysfunction despite of adequate therapy of heart failure (NYHA II, III, IV)
* implanted pacemaker, defibrillator or pacemaker during CS intubation
* written informed consent
* open entryways

Exclusion Criteria:

* anemia Hemoglobin (HB)\<8 mg/dl
* lying coronary sinus (CS) tube or CS being not able to intubate
* chronic atrial fibrillation or flutter
* mechanic tricuspid valve prothesis
* no access via subclavian vein
* patients with VVI pacemaker being stimulated 110%
* idiopathic hypertrophic cardiomyopathy, restrictive constrictive cardiomyopathy or heart failure because of known inflammatory or infiltrative illnesses or constrictive illness
* acute myocardial ischemia presented by angina pectoris or ECG changes under load
* patients being hospitalized because of heart failure during the last month and have to be treated with intravenous diuretics or inotropic substances
* acute coronary syndrome should not be implanted for at least 3 month
* patients with mechanic aortic or tricuspid valve
* patients after heart transplantation
* patients with clinical significant ectopy, defined by \> 8.900 PVCs during 24 hours at beginning Holter monitoring
* patients after hypertensive crisis
* patients with acute renal failure
* Ejection Fraction (EF) \> 35
* patients after left ventricular pacemaker electrode
* pregnant or breast feeding women
* patients with heart failure after sepsis

Primary outcomes:
measure: positive inotropic effects by CCM stimulation
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Univeristy Hospital Aachen
state: North Rhine Westfalia
Study officials:
affiliation: RWTH Aachen, Medical Departement I Univerity Hospital Aachen
name: Sebastian Reith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04708912: Nasopharynx Microbiota Component and in Vitro Cytokines Production in Coronavirus Disease (COVID-19)
Official title: TUSEB-Nasopharynx Microbiota Component and in Vitro Cytokines Production in Coronavirus Disease (COVID-19)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2021-01-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults (18-80 yerars ), both gender

Brief summary: The investigators will study nasopharunx microbiota composition, RNA sequences and in vitro cytokines production by peripheral blood cells of COVID-19 patients (both mild-moderate and severe cases) (comparing with convalescent patients and healthy controls).

Detailed description: The investigators will compare study parameters (basal) between mild-moderate and severe COVID-19 patients and with other study groups (i.e. convalescent and healthy controls). Nasopharunx microbiota dysbiosis, in vitro cytokines production profile, and peripheral blood flocytometric results of the four study groups will be compared.

In vitro cytokines production will be studied and compared in Nill (No antigens) and Mitojen (Cocktail of antigens) pre-prepared test tubes.

Eligibility criteria: Inclusion Criteria:

* Ability to give a written consent

Exclusion Criteria:

* In ability to give a written consent
* Using of medications that affect the results of study parameters
* Presence of malignancy or tuberculosis

Primary outcomes:
measure: Determination of peripheral blood RNA microarray assay
timeFrame: First day
measure: Determination of nasopharunx Microbiota analysis
timeFrame: 1st day
measure: Determination of in vitro cytokines production
timeFrame: First day
measure: Determination of peripheral blood cytometry
timeFrame: First day
measure: Relation between study parameters
timeFrame: First day parameters
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr.sadi Konuk Training and Research Hospital
city: Istanbul
country: Turkey
facility: Bakirkoy Dr.sadi Konuk Training and Research Hospital
Study officials:
affiliation: Basaksehir Cam and sakura Sehir Hospital
name: Mehmet Hursitoglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Microbiota and viral infections
Clinical trial NCT02513212: A Clinical Study to Determine the Safety and Effectiveness of Dentinal Hypersensitivity Treatment With Two Different Toothbrushes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Keywords: Sensitivity
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2015-07-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the effects toothbrush type (power or manual) has on the safety and effectiveness of professional dentinal hypersensitivity treatment with a marketed oxalate-containing solution.


Eligibility criteria: Inclusion Criteria:

* be at least 18 years of age;
* provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* complete a photography consent agreement pertaining to the collection and use of non-identifying intraoral photographs;
* be in good general health as determined by the Investigator/designee; and
* have at least one tooth with a Schiff sensitivity score of at least 1 in response to the cool air challenge.

Exclusion Criteria:

* self-reported pregnancy or nursing;
* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
* active treatment of periodontitis;
* any diseases or conditions that might interfere with the safe completion of the study; or
* an inability to undergo any study procedures.

Primary outcomes:
measure: Change From Baseline Air Challenge
timeFrame: 30 days
Secondary outcomes:
measure: Change From Baseline Visual Analog Scale
timeFrame: 30 days
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Chad J Anderson DMD Inc
state: California
Study officials:
References:
Clinical trial NCT01800812: Effects of OM-174 in Adult Patients With Solid Tumors
Official title: Phase One Study With Direct Individual Benefit: Effects of OM-174 in Adult Patients With Solid Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-02-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED

Brief summary: Methods Patients received OM-174 twice weekly for a total of 5, 10 or 15 injections of either 600, 800 or 1000 µg/m². Pharmacokinetic analysis and cytokine dosages were performed. Natural Killer cells activity and toll-like receptors 4 polymorphism analysis were also performed.


Eligibility criteria: Inclusion Criteria:

* Patient with a histologically proven solid tumor, refractory to conventional treatment or for which no such treatment existed.
* At least one month since the last chemotherapy
* Life expectancy above 3 months
* Written informed consent
* Age above 18

Exclusion Criteria:

* Patient's refusal
* Infection
* Brain metastasis
* Autoimmune disease
* Regular use of steroids
* Patient included in another protocol
* Chemotherapy or radiotherapy less than 6 weeks ago
* Immunotherapy less than 8 weeks ago

Primary outcomes:
measure: The occurrence of any adverse event
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Isambert N, Fumoleau P, Paul C, Ferrand C, Zanetta S, Bauer J, Ragot K, Lizard G, Jeannin JF, Bardou M. Phase I study of OM-174, a lipid A analogue, with assessment of immunological response, in patients with refractory solid tumors. BMC Cancer. 2013 Apr 2;13:172. doi: 10.1186/1471-2407-13-172.
Clinical trial NCT02320812: Safety of a Single, Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Retinitis Pigmentosa
Official title: A Prospective, Multicenter, Open-Label, Single-Arm Study of the Safety and Tolerability of a Single, Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa (RP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Retinitis Pigmentosa (RP)
Lead sponsor: jCyte, Inc
Sponsor class: INDUSTRY
Collaborators: name: California Institute for Regenerative Medicine (CIRM)
First posted: 2014-12-19
Enrollment: 28
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: This study evaluates the safety and potential activity of a single dose of live human retinal progenitor cells (jCell) administered to adults with retinitis pigmentosa. Four different dose levels of cells will be assessed in each of two groups of patients.

Detailed description: The primary purpose of this study is to test the safety and tolerability of the administration of a single dose of jCell to adults with retinitis pigmentosa.

The goal of jCell therapy is to preserve vision by intervening in the disease at a time when host photoreceptors can be protected and potentially reactivated.

Human allogeneic retinal progenitor cells will be injected into adults with advanced RP to see if the procedure is safe, if the cells survive, and whether they have any impact on the visual status of the patients.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of RP confirmed by electroretinogram (ERG) and willing to consent to mutation typing, if not already done
* Best corrected visual acuity (BCVA) 20/63 or worse and no worse than hand motions (HM)
* Adequate organ function and negative infectious disease screen
* Female of childbearing potential must have negative pregnancy test and be willing to use medically accepted methods of contraception throughout the study

Exclusion Criteria:

* Eye disease other than RP that impairs visual function
* Pseudo-RP, cancer-associated retinopathies
* History of malignancy or other end-stage organ disease, or any chronic disease requiring continuous treatment with system steroids, anticoagulants or immunosuppressive agents
* Known allergy to penicillin or streptomycin

Primary outcomes:
measure: Number of Subjects With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 12 months
Secondary outcomes:
measure: Change in Mean Best Corrected Visual Acuity (BCVA)
timeFrame: 12 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: The Gavin Herbert Eye Institute, Univ California Irvine
state: California
city: Los Angeles
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
Study officials:
affiliation: Gavin Herbert Eye Institute, UCI, Irvine, CA
name: Baruch Kuppermann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05706012: Antithrombotic Management of Acute Mesenteric Ischaemia
Official title: Long-term Antithrombotic Management of Acute Mesenteric Ischaemia: Case-based Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Mesenteric Ischemia
Short Bowel Syndrome
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: international gastro-enterologists an cardiologists

Brief summary: Guidelines on the acute and long-term pharmacological treatment of acute mesenteric ischaemia (AMI) recommend the use of thrombolytic, antiplatelet or anticoagulant therapy depending on the aetiology of AMI and the use of stenting but only few details are given on the choice of the drug, dose and duration of treatment. Besides, recommendations are mainly based on data on coronary, cerebral and other peripheral artery diseases and do also not take into account the altered drug absorption in patients with short bowel syndrome, in which AMI can result.This case-based survey will inform us on the current international clinical practice of long-term antithrombotic management of AMI.


Eligibility criteria: Inclusion Criteria:

* gastro-enterologist or cardiologist with expertise in treating SBS patients resulting from AMI

Exclusion Criteria:

* none

Primary outcomes:
measure: Type of antithrombotic therapy
timeFrame: April 2023
Secondary outcomes:
measure: Duration of antithrombotic therapy
timeFrame: April 2023
measure: Initial dose of antithrombotic therapy
timeFrame: April 2023
measure: Dose adjustments of antithrombotic therapy
timeFrame: April 2023
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
References:
Clinical trial NCT01080612: A Study To Assess The Pharmacokinetics, Safety, And Tolerability Of A Pregabalin Controlled Release Formulation Administered Following Various Sized Caloric Meals As Compared To The Pregabalin Immediate Release Formulation
Official title: An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Pregabalin Controlled Release Formulation Administered Following Various Caloric Intakes As Compared To The Immediate Release Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pregabalin
pharmacokinetics
bioavailability
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-03-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to (1) evaluate the effect of caloric intake on the pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the safety and tolerability of a single dose of a 330 mg pregabalin controlled release formulation administered following various sized caloric meals and the 300 mg pregabalin immediate release capsule administered fasted.

Detailed description: To assess the single dose pharmacokinetics, safety, and tolerability of pregabalin controlled release formulation following various sized caloric meals relative to the immediate release formulation.

Eligibility criteria: Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Primary outcomes:
measure: Pregabalin area under the curve (AUC) from time of study drug administration to the last quantifiable plasma concentration (AUClast) and to infinity (AUCinf)
timeFrame: 3 days
Secondary outcomes:
measure: Adverse events, vital signs, and clinical safety laboratories.
timeFrame: 3 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Chew ML, Plotka A, Alvey CW, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):617-26. doi: 10.1007/s40261-014-0211-4.
Clinical trial NCT01335412: Safety Surveillance After Immunization With IXIARO
Official title: Active Surveillance for Adverse Events After Immunization With IXIARO(R) Among U.S. Military Service Personnel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Japanese Encephalitis
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2011-04-14
Enrollment: 20000
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Active duty military personnel (Army, Navy, Air Force, and Marines) who are ≥17 years of age and received at least one dose of Japanese encephalitis vaccine.

Brief summary: This is an active electronic surveillance using data from the Defense Medical Surveillance System (DMSS) to detect and characterize serious, rare adverse events occurring within 42 days after vaccination with the Japanese Encephalitis Vaccine IXIARO within the US Military, to detect adverse events that occur more frequently after IXIARO and to electronically follow up pregnancies during or shortly before which IXIARO was administered.

There will be no intervention and no individuals contacted.


Eligibility criteria: Inclusion Criteria:

* Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of IXIARO (IXIARO exposed group) or at least one dose of JE-VAX (comparison group).

Exclusion Criteria:

* Individuals who have an ICD-9-CM code suggestive of one of the predefined adverse events screened for in IC51-401 prior to vaccination with IXIARO cannot with certainty be classified as being "disease free" at study entry and will be excluded for that adverse event.

Primary outcomes:
measure: Incidence of pre-defined, serious adverse events
timeFrame: 42 days after each dose of IXIARO
Secondary outcomes:
measure: Detection of non-predefined Adverse Events overrepresented after IXIARO
timeFrame: 42 days after each dose of IXIARO
measure: Occurrence of complications during pregnancy
timeFrame: Up to delivery
measure: Occurrance of infant health complications
timeFrame: up to 3 months after birth
Other outcomes:
Locations:
city: Alexandria
country: United States
facility: Military Vaccine Agency
state: Virginia
Study officials:
affiliation: Valneva Austria GmbH
name: Katrin L Dubischar-Kastner, MSc
role: STUDY_DIRECTOR
References: