louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01178190: The Role of Narrow Band Imaging Videobronchoscopy in Lung Cancer
Official title: The Diagnostic Yield of Narrow Band Imaging Videobronchoscopy in Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: narrow band imaging
malignant lesion
lung cancer
NBI
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 101
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: suspected endobroncheal lesion on chest CT

Brief summary: Narrow band imaging (NBI) videobronchoscopy is an optical technique in which filtered light enhances superficial neoplasm based on their neoangiogenic pattern. The objectives of this study investigate its better diagnostic yield in the assessment of lung cancer than conventional flexible bronchoscopy.

Detailed description: Inspection with high resolution endoscopy was followed by NBI. Detected lesions were biopsied. applied the system of shibuya et al. to analyze and classify vascular patterns by NBI into four categories (spiral and screw pattern, dotted pattern, tortuous pattern, avascular pattern) compared with the known diagnostic yield of conventional white light bronchoscopy, An equivalent or superior result will also significantly impact on patient care This technology could aid not only early-stage lung cancer diagnosis but also more accurate local staging of lung cancer.

Eligibility criteria: Inclusion Criteria:

* endobronchial lesion on chest CT

Exclusion Criteria:

* Age \< 18 years old
* Inability to consent for the study
* Inability to tolerate bronchoscopy
* Active pulmonary infection (bronchitis, pneumonia)
* ST elevation or depression on ECG
* Prothrombin time prolongation(\<70%)
* platelet \<10,000

Primary outcomes:
measure: accuracy of NBI videobronchoscopic biopsy
timeFrame: 10-11 months
Secondary outcomes:
measure: early cancer lesion detection rate using Shibuya descriptors
timeFrame: 10-11 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ChangMin, Choi
Study officials:
affiliation: Asan Medical Center
name: ChangMin Choi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04824690: The Effect Of Immersive Virtual Reality Application On Anxiety, Pain And Family Satisfaction In The Perioperative Process Of Children
Official title: The Effect Of Immersive Virtual Reality Application On Anxiety, Pain And Family Satisfaction In The Perioperative Process Of Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pain
Satisfaction
Keywords: Anxiety
Pain
Parental Satisfaction
Virtual Reality
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 70
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: An immersive virtual reality (VR) tour of the operating theater before surgery could reduce preoperative anxiety. The aims of this study were to analyze whether a preoperative virtual reality tour shows a reduction in anxiety in children and an increase in parental satisfaction.

Detailed description: Children who will undergo surgery for the first time and their families were randomly allocated into the control or VR group. The control group received conventional education regarding the perioperative process of surgery. The VR group watched a 1.5-minute VR video showing the operating theater and explaining the perioperative process. The main finding was preoperative anxiety evaluated using the Children's State Anxiety (CSA) before surgery. Secondary findings included children's postoperative pain ratings using Wong-Baker Faces Pain Rating Scale and parental satisfaction scores using PedsQL Health Care Satisfaction Scale

Eligibility criteria: Inclusion Criteria:

* Children 4-10 years old
* ASA grade I or II
* General anesthesia
* Elective surgery

Exclusion Criteria:

* Children who have had previous surgery history
* Local anesthesia or emergency surgeries
* Premature or congenital disease history
* Having visual and hearing impairment
* Mental and developmental retardation
* Having a history of epilepsy and seizures
* Patients taking psychoactive drugs

Primary outcomes:
measure: Preoperative anxiety assessed by the Children's State Anxiety (CAM-S)
timeFrame: This is measured right before the child goes into operating theatre / separating from his/her parents.
Secondary outcomes:
measure: Postoperative Pain assessed by the Wong-Baker Faces Pain Rating Scale
timeFrame: This is measured immediately after the surgery.
measure: Parental Satisfaction assessed by PedsQL Health Care Satisfaction Scale
timeFrame: This is measured immediately after the intervention.
measure: Postoperative anxiety assessed by the Children's State Anxiety (CAM-S)
timeFrame: This is measured immediately after the surgery.
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant İzzet Baysal University
Study officials:
References:
Clinical trial NCT01992003: Butterfly Sensor With Rev K Version
Official title: Assessing the Accuracy of the Butterfly Sensor With RevK Version for Non-Invasive Hemoglobin Monitoring
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Blood Loss
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing spine surgery

Brief summary: The primary purpose of this study is to assess the accuracy of the newly released Masimo SpHb Butterfly Sensor with RevK version and compare the results to a blood hemoglobin level analyzed in the UCSF Clinical Laboratories. A secondary purpose is to assess the blood hemoglobin using the Masimo Pronto-7 hand-held device immediately prior to surgery.

Detailed description: * Masimo SpHb™ continuous hemoglobin monitoring The Masimo SpHb™ monitor with the Butterfly Sensor with RevK version will be used to continuously monitor hemoglobin electronically. The Butterfly Sensor will be connected to the 3rd or 4th finger on either the right or left hand.
* Masimo Pronto-7™ intermittent hemoglobin monitoring The Masimo Pronto-7™ is a hand-held, noninvasive device used for intermittent measuring of blood hemoglobin. The device is connected to a re-usable sensor which is clipped onto a finger for quick spot-check readings. A reading from the Pronto-7 will be taken immediately before surgery.
* Blood sampling for hemoglobin determination For the study, about a ½ tsp of blood will be collected from the arterial line placed for the purpose of surgery approximately every hour during the surgery to obtain a hemoglobin measurement to be analyzed in the UCSF Clinical Lab.

Eligibility criteria: Inclusion Criteria:

* Male of non-pregnant female 18 y/o or older
* American Society of Anesthesiologists Classification 1,2 or 3
* Scheduled to undergo spine or hip surgery

Exclusion Criteria:

* Pregnant or nursing
* Patients who in the investigators clinical judgement would not be suitable for research

Primary outcomes:
measure: The primary purpose of this study is to assess the accuracy of the newly released Masimo SpHb Butterfly Sensor with RevK version and compare the results to a blood hemoglobin level.
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ronald D Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00272103: Itopride in Functional Dyspepsia:a Dose Finding Study
Official title: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Dose Finding Study in 4 Parallel Groups to Establish the Efficacy and Safety of an Eight Week Treatment With Itopride Three Times Daily Compared to Placebo in Patients Suffering From Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Functional Dyspepsia
Keywords: functional dyspepsia
non ulcer dyspepsia
drug treatment
Lead sponsor: Royal Adelaide Hospital
Sponsor class: OTHER
Collaborators: name: Knoll Pharmaceuticals, Germany (now Abbott)
name: University Hospital, Essen
First posted: 2006-01-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine the efficacy and optimal dose of the prokinetic itopride for the treatment of patients with functional dyspepsia.

The study will test in patients with functional dyspepsia the hypothesis that itopride is superior to placebo with regard to the improvement of symptoms.

Detailed description: Treatment of patients with functional dyspepsia remains unsatisfactory. We will assess the efficacy of Itopride, a D2 antagonist with acetylcholinesterase effects in patients with functional dyspepsia.

Patients with functional dyspepsia will be randomized to Itopride (50, 100 or 200 mg tid) or placebo. After 8 weeks of treatment, three primary efficacy endpoints will be analyzed: a) change of the severity of functional dyspepsia symptoms (assessed by the Leeds Dyspepsia Questionnaire), b) patient's global assessment of efficacy (proportion of patients symptom-free or markedly improved)and c) improvement of pain and/or fullness by at least one grade on a 5-grade scale.

Eligibility criteria: Inclusion Criteria:

Diagnosis of functional dyspepsia (Rome criteria) -

Exclusion Criteria:

structural or biochemical abnormalities explaining the symptoms, concomitant symptoms of gastroesophageal reflux disease or irritable bowel syndrome dominating the clinical picture

-

Primary outcomes:
measure: After 8 weeks of treatment:
measure: Change of the severity of functional dyspepsia symptoms assessed by the Leeds Dyspepsia Questionnaire)
measure: Patient's global assessment of efficacy (proportion of patients symptom-free or markedly improved)
measure: Improvement of pain and/or fullness by at least one grade on a 5-grade scale.
Secondary outcomes:
measure: Safety parameters
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
Study officials:
affiliation: Royal Adelaide Hospital, University of Adelaide
name: Gerald J Holtmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holtmann G, Talley NJ, Liebregts T, Adam B, Parow C. A placebo-controlled trial of itopride in functional dyspepsia. N Engl J Med. 2006 Feb 23;354(8):832-40. doi: 10.1056/NEJMoa052639.
Clinical trial NCT06133803: Lovenox With Aspirin in Thawed Blastocyst Transfer
Official title: Lovenox With Aspirin in Thawed Blastocyst Transfer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Infertility, Female
Lead sponsor: Fertility Center of Las Vegas
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial comparing treatment to controls.
Primary purpose: TREATMENT

Brief summary: This prospective randomized trial will compare outcomes in patients receiving aspirin in combination with a low-molecular weight heparin and those under this center's standard protocol receiving neither medication, in order to determine if these medications may improve success rates.

Detailed description: This prospective randomized trial will compare outcomes in patients receiving aspirin (81mg daily) in combination with a low-molecular weight heparin (LMWH) (enoxaparin (Lovenox®), 40mg daily subcutaneous injection) and those under this center's standard protocol receiving neither medication, in order to determine if these medications may improve success rates.

Eligibility criteria: Inclusion Criteria:

1. Female patient 18-42 years of age with frozen embryos or oocytes seeking embryo transfer.
2. Use of pre-implantation genetically tested (PGT) blastocysts is allowed but not required.
3. Use of donated embryos or embryos derived from donated eggs is allowed.
4. Prior history of successful, failed, and/or canceled IVF cycles are allowed.

Exclusion Criteria:

1. Minor (age\<18 years).
2. Currently pregnant.
3. Unable to provide informed consent in English.
4. Gestational carrier or "surrogate".
5. Blastocysts frozen at another center (Oocytes frozen elsewhere is acceptable).
6. Subject intending or having "natural cycle" thaw transfer with an active ovarian follicle present.
7. Currently participating in any other research study.
8. Subject already had an embryo transfer under this study.
9. History of thrombocytopenia (reduced platelets), bleeding disorders, or routinely using anti-coagulant medication.
10. Hypersensitivity to aspirin, heparin, or benzyl alcohol.
11. Anyone for whom the physician assesses this protocol is inappropriate or unsafe.

Primary outcomes:
measure: Serum hCG level
timeFrame: 5 days post transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Fertility center of Las Vegas
state: Nevada
Study officials:
affiliation: Fertility Center of Las Vegas
name: Bruce Shapiro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02239003: NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild Cognitive Impairment
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: NMDA neurotransmission plays an important role in learning and memory. NMDA receptors were found to decrease in the frontal lobe and hippocampus of mild cognitive impairment. This study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be allocated randomly to 2 groups: (1) NMDA-enhancer: DAOIB group (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOIB may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of mild cognitive impairment
* MMSE between 17-26
* CDR 0.5

Exclusion Criteria:

* Hachinski Ischemic Score \> 4
* Substance abuse/dependence
* Parkinson disease, epilepsy, dementia with psychotic features
* Major depressive disorder
* Major physical illnesses
* Severe visual or hearing impairment

Primary outcomes:
measure: Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
Secondary outcomes:
measure: Change from baseline in speed of processing (Category Fluency) at week 24
timeFrame: week 0, 24
measure: Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24
timeFrame: week 8, 16, 24
measure: Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24
timeFrame: week 0, 24
measure: Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24
timeFrame: week 0, 24
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chieh-Hsin Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University, China
name: Hsien-Yuan Lane, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03776903: Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA
Official title: Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Zika Virus Infection
Lead sponsor: InBios International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Fast-Track Drugs & Biologics, LLC
name: Biomedical Advanced Research and Development Authority
First posted: 2018-12-17
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Human males and females of varying ages and geographical locations where Zika virus is endemic and not endemic.

Brief summary: The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples.

Detailed description: The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples. The FDA guidance document (ZIKA SEROLOGY DE NOVO/510(K) PRE-MARKET SUBMISSIONS - Recommended Analytical and Clinical Studies for Zika Virus IgM Assays; Dated 02Jun2017; FDA/CDRH/OIR/DMD) allows for the utilization of archival serum specimens to evaluate test performance. This study will follow this guidance. Test samples will be collected from endemic sites (both presumed positive and presumed negative samples) and from non-endemic sites (presumed negative samples). All samples will be shipped to the sponsor for randomization and will be tested at three sites in the United States.

Eligibility criteria: Inclusion criteria:

* Human males and females of varying ages and geographical locations where Zika virus is endemic and not endemic.
* Retrospective (archived) and prospective human serum samples. Archived samples will fall under the category of "leftover" specimens as described by FDA guidance.

Exclusion criteria:

• Samples that are not de-identified.

Primary outcomes:
measure: Positive Percent Agreement and Negative Percent Agreement
timeFrame: From symptom onset to 12 weeks after symptom onset.
Secondary outcomes:
measure: Duration of Positive Percent Agreement
timeFrame: From symptom onset to 12 weeks after symptom onset.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: InBios International
state: Washington
Study officials:
affiliation: InBios International
name: Frances Chu, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02510703: Assessment of Coronary Endothelial Function in Diabetic Patients With Acute Coronary Syndrome Using 15O-water Positron Emission Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Type 2 diabetes is associated with early and diffuse abnormalities of endothelial function, especially in the coronary arteries, which are a factor of poor prognosis. Following acute coronary syndrome, the endothelial function abnormalities usually persist for several weeks before regressing. Their persistence 6-8 weeks after myocardial infarction is a poor prognostic factor. Investigators assume that global abnormalities of endothelial function in patients with diabetes may be additive with segmental abnormalities in revascularized myocardium, and contribute to worsening the prognosis in these patients. Furthermore, there is no published data showing any relationship between calcium score and endothelial function abnormalities in these patients. The investigators seek a relationship between calcium score and persistence of abnormalities of coronary endothelial function in these patients.

The main objective of this study was to compare coronary endothelial function by quantitative method (TEP at 15O-H2O) in diabetic patients and nondiabetic following acute coronary syndrome.


Eligibility criteria: Inclusion Criteria:

* Patients with a first myocardial infarction, type 2 diabetic or non-diabetic treated by angioplasty in acute phase (TIMI 3)
* Myocardial viability test before discharge
* Age over 18 years
* Informed Consent dated and signed by the patient
* Written and spoken French
* Beneficiary of social security insurance

Exclusion Criteria:

* Hypertension\> 160/90 mmHg despite medical treatment
* Lack of effective revascularization in acute phase of myocardial infarction (TIMI grade \<3)
* Significant three-vessel coronary artery disease (\> 70% stenosis in the other two coronary arteries); occlusion of a coronary artery; schedule revascularization (percutaneous or surgical); left main coronary artery stenosis
* Previous history of myocardial infarction
* Mechanical complication (mitral regurgitation, ventricular septal rupture, left ventricular free wall rupture)
* Heart failure
* No myocardial viability test before discharge, for whatever reason
* Type 1 diabetes
* Pregnant and / or lactating
* Age under 18 years or guardianship

Primary outcomes:
measure: Comparison of quantitative variables coronary endothelial function in PET according to the presence or absence of type 2 diabetes in patients investigated with the waning of a first heart attack
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Service de Cardiologie
Study officials:
References:
Clinical trial NCT01035203: Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue
Official title: Effects of a Brief Endurance Exercise Program and of a Cognitive Behavioural Therapy on Patients With Cancer-related Fatigue
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fatigue
Mood
Maximal Oxygen Uptake
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2009-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators compare the effects of two interventions, an endurance exercise program and a cognitive behavioural therapy, on the fatigue, quality of life, mood and physical performance of patients with a cancer-related fatigue syndrome. The intervention will be carried out for 4 weeks. Tests will be carried out at the beginning and at the end of the study.


Eligibility criteria: Inclusion Criteria:

* Age 18-70
* Histologically confirmed neoplastic disease
* Treatment (chemotherapy or radiation) completed.
* No treatment in the previous 4 weeks
* Ability to understand written German

Exclusion Criteria:

* Health conditions which can be aggravated by exercise

Primary outcomes:
measure: Fatigue scores on the Brief Fatigue Inventory (BFI)
timeFrame: 4 weeks
Secondary outcomes:
measure: Maximal oxygen uptake (VO2max) on a treadmill stress test.
timeFrame: 4 weeks
measure: Scores on the HADS (Hospital Anxiety and Depression Scale)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Sports Medicine
Study officials:
References: