louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02360839: The Use of FNA and FNB in the Optimization of EUS-assisted Tissue Sampling
Official title: The Use of FNA and FNB in the Optimization of EUS-assisted Tissue Sampling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2015-02-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology and/or fine needle biopsy (FNB) for histology may be used in the diagnostic work-up of intrathoracic and intrabdominal lesion of unknown origin. Certain lesions (such as pancreatic adenocarcinoma) are often well characterized by cytology assessment of FNA-samples while others are not (such as GIST-tumors).

This study is a part observational (early study phase) and part interventional study (late study phase) on the diagnostic accuracy of EUS-assisted tissue sampling by FNA or FNB during a 10-year period on a tertiary endoscopy centre.

Detailed description: Variables affecting the diagnostic accuracy of EUS-FNA and EUS-FNB in different cases and tumor scenarios will be studied in detail such as the influence of medical equipment used (i.e the different types and sizes of puncture needles), the experience of the endosonographers, cytopathologists and pathologists and the use of rapid on-site evaluation of cytology samples.

Each study case is reviewed post-EUS (according to the schedule precised below) regarding further diagnostic work-up, neoadjuvant treatment, surgery result, clinical follow-up, (neo)adjuvant treatment, and survival. Non-parametrical tests will be applied as the main statistical method.

Eligibility criteria: Inclusion Criteria:

* Referral for a diagnostic EUS

Exclusion Criteria:

* Referral for an interventional EUS

Primary outcomes:
measure: The cellular quality of the EUS-FNA specimens (categorical variable).
timeFrame: Follow up is by time of surgery (in average 2 months after EUS-FNA)
measure: The histological quality of the EUS-FNB specimens (categorical variable).
timeFrame: Follow up is by time of surgery (in average 2 months after EUS-FNB)
Secondary outcomes:
measure: Immunohistochemistry profiling of EUS
timeFrame: Follow up is by time of surgery (in average 2 months after EUS)
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dr Per Hedenström
Study officials:
affiliation: Sahlgrenska University Hospital, Gothenburg
name: Riadh Sadik, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hedenstrom P, Demir A, Khodakaram K, Nilsson O, Sadik R. EUS-guided reverse bevel fine-needle biopsy sampling and open tip fine-needle aspiration in solid pancreatic lesions - a prospective, comparative study. Scand J Gastroenterol. 2018 Feb;53(2):231-237. doi: 10.1080/00365521.2017.1421704. Epub 2018 Jan 4.
Clinical trial NCT01742039: Prevention of Postoperative Atrial Fibrillation
Official title: A New Therapeutic Strategy to Reduce the Incidence of Postoperative Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Atrial Fibrillation
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients undergoing open heart surgery

Brief summary: The primary aim of this study is to determine the safest and most effective therapeutic strategy to decrease the incidence of postoperative atrial fibrillation following cardiac surgery in an era with shorter ICU and hospital length of stay. A secondary goal is to evaluate the length of hospital stay associated with each treatment strategy.


Eligibility criteria: Inclusion Criteria:

* age \> or = to 18 years
* sinus rhythm
* undergoing either coronary artery bypass graft surgery (CABG), valvular heart surgery or a combined procedure

Exclusion Criteria:

* received a class-I or class-III antiarrhythmic agent in the past six months
* had second or third degree heart block
* had a resting heart rate of less than 50 beats per minute
* had a systolic blood pressure less than 100 mmHg
* had severe asthma or severe chronic obstructive pulmonary disease
* had uncontrolled heart failure
* had a serum aspartate aminotransferase or alanine aminotransferase concentration greater than four times the upper limit of normal

Primary outcomes:
measure: occurrence of atrial fibrillation
timeFrame: postoperative day 0-day of discharge (an average of 5 days)
measure: occurrence of atrial fibrillation
timeFrame: postoperative day 0-day of discharge (an average of 5 days)
Secondary outcomes:
measure: length of stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
Study officials:
References:
Clinical trial NCT01844739: A Phase 1 Study Evaluating Safety and Tolerability of NVN1000 Gel
Official title: A Phase 1, Multiple-dose, Evaluator-blind, Randomized, Parallel Group Study Evaluating the Safety and Cutaneous Tolerability of SB204 (NVN1000 Gel) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Keywords: Propionibacterium acnes
acne
Lead sponsor: Novan, Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-01
Enrollment: 30
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 is a 2 week Phase 1 study of SB204 (NVN1000 Gel) in healthy adult volunteers with elevated Propionibacterium acnes (P. acnes) counts. Subjects will apply NVN1000 4% Gel or Vehicle Gel twice daily to their face. Assessments will include cutaneous tolerability, safety, and P. acnes counts.

Detailed description: In this single-center, vehicle gel-controlled, evaluator and subject blinded study, approximately 30 otherwise healthy adult subjects with elevated P. acnes counts will be randomized 2:1 to NVN1000 4% Gel or Vehicle Gel. The subjects will apply the test material twice daily to their face after washing. Subjects will be seen daily at the skin study center during the week and will apply their evening and weekend dose at home. Cutaneous tolerability will be assessed by the Investigator at Baseline, Week 1, and Week 2. Safety assessments include collection of adverse events, laboratory results, and clinically significant changes in physical examination. P. acnes counts will be obtained at Baseline, Week 1 and Week 2.

Eligibility criteria: Inclusion Criteria:

* Healthy adult male or female volunteers
* If a woman of child-bearing potential, agrees to use effective method of birth control during the study and for 30 days after the final study visit
* Agree to refrain from use of antimicrobial topical products during study

Exclusion Criteria:

* Any skin disorders of acute or chronic nature including psoriasis, eczema, etc
* Female subjects who are pregnant, nursing, or planning to become pregnant
* Subjects who have used topical or systemic antibiotics, estrogens, drugs associated with methemoglobinemia, nitrate donors
* Subjects with baseline methemoglobin \> 2%
* Subjects with clinically significant anemia

Primary outcomes:
measure: Tolerability based on the cutaneous tolerability scores
timeFrame: 2 weeks
Secondary outcomes:
measure: Safety which includes reported adverse events, clinically significant changes in physical exam, and labs
timeFrame: 2 weeks
Other outcomes:
measure: Change in P. acnes counts
timeFrame: 2 weeks
Locations:
city: Broomall
country: United States
facility: KGL
state: Pennsylvania
Study officials:
affiliation: Novan, Inc.
name: Joyce Rico, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03991039: Comparing Clinical Benefits of Gamma Knife and Microvascular Decompression for Trigeminal Neuralgia
Official title: Treatment of Primary Trigeminal Neuralgia: A Comparative Study of Microvascular Decompression and Stereotactic Gamma Knife Radiosurgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigeminal Neuralgia
Keywords: Trigeminal neuralgia, treatment
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical randomized study to compare the clinical effectiveness between two modalities of treatment of trigeminal neuralgia namely gamma knife radio surgery and microvascular decompression

Detailed description: A randomized prospective study conducted in The Neurosciences Hospital, Baghdad, from January 2016 to January 2018, patients had either GKR treatment or treated with MVD. The pain evaluated pre- and post-operatively using the Barrow Neurological Institute Pain Intensity scale (BNIPI), visual analog scale (VAS) and Brief Pain Inventory Facial (BPI-Facial) scoring systems. In GKR procedure, the trigeminal root entry zone targeted with a radiation dose of 80 Gy. MVD was performed using retro-sigmoid approach. Follow-up period for two years

Eligibility criteria: Inclusion Criteria:

* primary idiopathic trigeminal neuralgia

Exclusion Criteria:

* secondary trigeminal neuralgia

Primary outcomes:
measure: Barrow Neurological Institute Pain Intensity scale (1-5)
timeFrame: Two years
measure: visual analog scale (0-10)
timeFrame: Two years
measure: Brief Pain Inventory (1-7)
timeFrame: ُTwo years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Neurosciences hospital
name: Moneer K. Faraj, Facs
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01536639: Physiological Concept of Insulin Therapy in Subjects With Type 2 Diabetes
Official title: Physiological Concept of Insulin Therapy in Subjects With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 454
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with type 2 diabetes in whom at the discretion of the investigator it was decided to change insulin regimen to biphasic insulin aspart 30

Brief summary: This study is conducted in Europe. The aim of the study was to evaluate the safety and efficacy of biphasic insulin aspart 30 (NovoMix® 30) when switching to a modern premix insulin analogue treatment compared to previous insulin regimen in routine clinical practice in the Slovak Republic.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes

Primary outcomes:
measure: HbA1c (glycosylated haemoglobin)
Secondary outcomes:
measure: Fasting plasma glucose (FPG)
measure: Post-prandial glucose (PPG)
measure: Weight
measure: Hypoglycaemia
measure: Adverse events
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Significant reduction in proportion of T2 diabetes patients at high risk for developing late complications after switching human insulin to BIAsp 30; results of an observational study in Slovakia; Z. Schroner; 2085-PO; 69th American Diabetes Association, New Orleans 2009
Clinical trial NCT06385639: Efficacy and Safety of Probiotic Products for Digestive Health
Official title: A Double-blind, Randomized Clinical Study, Compared With Placebo to Assess the Efficacy and Safety of a Probiotic Product Containing Four Probiotic Strains to Support Digestive Environment and Homeostasis of Gut Microbiota
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Adult
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the efficacy and safety of the probiotic product as an everyday gut health product in supporting digestive environment and homeostasis of gut microbiota.


Eligibility criteria: Inclusion Criteria:

1. Male or Female subject age 18-60 years at screening
2. Healthy subject according to investigator judgement based on screening data
3. Subjects must be either of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for the entire study
4. Subjects who have not smoked in the past 1 month prior to screening
5. Subjects with a healthy and balanced diet, including adequate fiber intake in their food consumption
6. Subject or subject's legally acceptable representatives have the ability to comply with the trial protocol
7. Signed informed consent from the subjects or subject's legally acceptable representatives (must be obtained before any trial related activities)

Exclusion Criteria:

1. History of presence of diabetes, immunodeficiency disorders, or chronic illness
2. Regular use of medications known to affect the gastrointestinal system or alter gut microbiota composition, including but not limited to antibiotics, and immunosuppressants
3. Have continuous, daily use of probiotic or probiotic containing products within 1 month prior to randomization
4. Pregnant, planning a pregnancy or lactating female (urinary pregnancy test will be applied to female subjects at screening)
5. Change type of diet during study
6. Any known allergy or intolerance to any of the ingredients in the formulation of the product under study
7. History of drug, alcohol or other substance abuse, or other factors that limit their ability to cooperate during the study
8. History of or presence of eating disorder
9. Subject whose condition does not make them eligible to the study, according to the investigator

Primary outcomes:
measure: Intestinal health
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Danang@Equilab-Int.Com
state: Pusat
Study officials:
References:
Clinical trial NCT00813839: Automated Ventilator Controlled Weaning vs Daily Spontaneous Breathing Trial in Difficult to Wean ICU Patients
Official title: Comparison of Automated Ventilator Controlled Weaning to Daily Spontaneous Breathing Trial Weaning Protocol in ICU Patients Following Prolonged Mechanical Ventilation.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Mechanical Ventilation
Weaning
Keywords: SmartCare
Spontaneous Breathing Trials
Mechanical Ventilation
Weaning
Patients requiring prolonged mechanical ventilation (>72 hours)
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-12-23
Enrollment: 0
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: This study will compare Drager Smart Care (SC), a commercially available automated ventilator controlled weaning mode to the current daily spontaneous breathing trial (SBT) weaning protocol. The study is designed to determine if automated ventilator controlled weaning can reduce total duration of intubation following mechanical ventilation in ICU patients requiring prolonged mechanical ventilation (\>72 hours).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Intubated with endotracheal tube
* Requiring mechanical ventilation for \> 72 hours
* Meets weaning criteria: Improvement or resolution of the underlying process that precipitated need for mechanical ventilation, PaO2 ≥ 60 mm Hg on PEEP and FiO2 Requirements of ≤ 8 cm H2O and FiO2 ≤ 0.50, Stable oxygenation: PEEP and FiO2 requirements not increased in the past 24 hrs, Ability to initiate an inspiratory effort and trigger the ventilator, Subject enrollment approved by the primary service attending physician

Exclusion Criteria:

* Pregnancy
* Patients with tracheostomy or planned tracheostomy prior to attempt to extubate
* Patients with known airway patency issues that are anticipated to delay extubation.
* Patients with neurological injury in whom care is likely to be withdrawn
* Patients with cervical spinal cord injury.
* Prospective subject or surrogate consenter does not fully understand the implications of the study because of a language barrier.

Primary outcomes:
measure: weaning time to successful spontaneous breathing trial
timeFrame: 28 days or extubation
measure: weaning time to successful extubation
timeFrame: 28 days or extubation
measure: ventilator weaning days
timeFrame: 28 days or extubation
measure: total duration of ventilatory support
timeFrame: 28 days or extubation
Secondary outcomes:
measure: reintubations within 48 hours
timeFrame: 48 hrs
measure: sedation and analgesic requirements
timeFrame: 28 days or extubation
measure: ICU and hospital length of stay
timeFrame: total time of ICU and hospital stay
measure: clinical staff time requirements
timeFrame: during active weaning period
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital, UCSF Dept. of Anesthesia
state: California
Study officials:
References:
Clinical trial NCT00146822: REFLEx Study (ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance
Official title: ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arrhythmia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The REFLEx Study will evaluate if ENDOTAK RELIANCE G defibrillation leads with GORE ePTFE-covered coils are as good as or better than other comparative commercially available defibrillation leads with respect to electrical performance and termination efficacy in spontaneous tachyarrhythmic episodes.


Eligibility criteria: Inclusion Criteria:

* Patients who meet current ICD or CRT-D indications
* Patients who are going to be implanted with one of the aforementioned ICD or CRT-D devices
* Patients who are going to be implanted with active-fixation, dual-coil, endocardial defibrillation leads with compatible connectors (i.e., ENDOTAK RELIANCE G or study-comparative ICD leads)
* Patients who sign and date a Patient Informed Consent form prior to device implant
* Patients who remain in the clinical care of the enrolling physician in approved centers
* Patients who are at least 18 years old

Exclusion Criteria:

* Patients who have a preexisting transvenous lead system that is not completely explanted
* Patients who are hypersensitive to a single dose of approximately 1.0 mg of dexamethasone acetate
* Patients who are expected to receive a heart transplant during the duration of the study
* Patients whose estimated life expectancy is less than 12 months due to other medical conditions
* Patients who currently have or who are likely to receive a tricuspid valve prosthesis
* Patients who are likely to have an open-chest surgery in the next three months
* Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the REFLEx study.
* Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
* Patients who are pregnant

Primary outcomes:
measure: Lead electrical properties
measure: First shock conversion success rate for spontaneous fast ventricular tachycardia or ventricular fibrillation
Secondary outcomes:
measure: Lead handling characteristics
measure: Lead migration/dislodgment rates
measure: Characterize the current ICD/CRT-D population
measure: Effects of ischemia and revascularization and previous lead extraction on the lead's electrical performance
Other outcomes:
Locations:
Study officials:
affiliation: Wake Heart Associates
name: Randolph Cooper, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01974622: ICG-Guided Photodynamic Therapy for Treatment of Retinal Capillary Abnormalities: A Pilot Study
Official title: Indocyanine Green Angiography-Guided Photodynamic Therapy for Treatment of Retinal Capillary Abnormalities.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Vascular Disorders
Lead sponsor: Manhattan Eye, Ear & Throat Hospital
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to use an approved drug(Visudyne) for neovascular age-related macular degeneration, which is essentially choroidal neovascularization for permeability and vascular proliferation for the retinal circulation, to treat another permeable abnormality - retinal capillary abnormalities - located eccentric to the central portion of the macula or in the foveal region.

Detailed description: The study will include 30 patients who were diagnosed with retinal capillary abnormalities and include 2 follow-up visits at 6 and 12 months post-procedure to determine if the treatment has been effective in treating their disorder. It is anticipated that approximately half of the patients will require an additional treatment. Patients will be enrolled from our patient population and be 50 years of age and older, male or female. Pregnant women or women of normal child bearing age will be excluded since there are no adequate and well-controlled studies on the use of photodynamic therapy in pregnant women. Any retinal vascular abnormality that has a standard of care method of treatment will also be excluded from the study population.

Eligibility criteria: Inclusion Criteria:• Individuals that are 50 years of age and older.

* Patients with retinal capilary abnormalities/vascular diseases such as macular telangiectasia type I and type II, retinal arteriolar macroanurysms, and retinal angiomous proliferation (RAP).
* Patients with diabetic retinopathy and branch retinal vein occlusions
* Other patients who are non-responders to approved treatment methods

Exclusion Criteria:

* Patients whose diseases have approved methods of treatment.
* Pregnant women or women of normal child bearing age.

Primary outcomes:
measure: Improvement and/or stabilization of disease.
timeFrame: 1-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Vitreous Retina Macula Consultants of New York
state: New York
Study officials:
affiliation: Northshore LIJ/MEETH
name: Lawrence A. Yannuzzi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yannuzzi LA, Slakter JS, Gross NE, Spaide RF, Costa DL, Huang SJ, Klancnik JM Jr, Aizman A. Indocyanine green angiography-guided photodynamic therapy for treatment of chronic central serous chorioretinopathy: a pilot study. 2003. Retina. 2012 Feb;32 Suppl 1:288-98. doi: 10.1097/iae.0b013e31823f99a9.