louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05784233: Relevance and Salience During Attention Task
Official title: Relevance and Salience During Attention Task
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: attention
visual search
Lead sponsor: Lehigh University
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants receive each level of task (easy singleton detection task, hard feature search task) and salient item presence (present, absent during search). Groups differ based on the likelihood of the salient item being the search target when present(0%-100%, in 25% increments).
Primary purpose: BASIC_SCIENCE

Brief summary: In this line of research, the researchers are examining the influence of relevance of a salient item on task performance, depending on overall task set.

Detailed description: When finding a target item during visual search (looking for a pencil), a salient item can capture attention (your phone flashing from a message). Typical attention studies only examine salient items when shown as distractor during search, to ensure any attention to the items are driven by salience alone. However, the impact of salience may interact with the relevance of the item for the search task (e.g. how likely the salient item is to be the target). Here, the researchers investigate these interactions in a basic science study when participants perform an easy task or a difficult search task.

Eligibility criteria: Inclusion Criteria:

* normal or corrected to normal visual acuity, normal color vision

Exclusion Criteria:

-

Primary outcomes:
measure: Button Press Reaction Time
timeFrame: During Testing (single day)
measure: Button Press Accuracy
timeFrame: During Testing (single day)
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: Lehigh University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01551433: Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy
Official title: A Prospective Trial to Evaluate Whether Variations in Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Keywords: esophagectomy
ESOPHAGUS
Wipox instrument
Tissue Oxygenation
Anastomotic Leak
11-192
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2012-03-12
Enrollment: 166
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Thoracic Surgery clinics

Brief summary: The purpose of this study is to test whether after an Ivor Lewis esophagectomy (the removal of a portion of the stomach and esophagus with re-attachment) there is an association between the intraoperative level of oxygen at the site where the esophagus is re-attached to the stomach (measured using the Wipox), and the incidence of a disruption at the site of the attachment after the surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled to undergo an open or a minimally invasive Ivor Lewis esophagectomy
* \> or = to 21 years of age

Exclusion Criteria:

* Patients who are not candidates for an esophagectomy as determined by the treating surgeon

Primary outcomes:
measure: association between tissue oxygenation (measured using the Wipox) at the anastomotic site and the incidence of anastomotic leak after an Ivor Lewis esophagectomy.
timeFrame: 2 years
Secondary outcomes:
measure: To correlate various demographic
timeFrame: 2 years
measure: To correlate anastomotic site tissue oxygenation with the postdischarge incidence of stricture
timeFrame: 2 years
measure: To correlate clinical variables
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Prasad Adusumilli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00985933: The Effects AZD8529 on Ketamine-induced Impairment of Working Memory in Healthy Volunteers
Official title: A Single Center, Double-Blind, Randomized, Double Dummy, Placebo-Controlled, Three-Period Crossover Study to Assess the Effects of a mGluR2/3 Positive Allosteric Modulator [AZD8529] Upon Ketamine-Induced Cortical Stimulation and Impairment of Working-Memory Related Activation of the Prefrontal Cortex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Memory Impairment
Keywords: Healthy normal volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-09-29
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess if ketamine will induce, in healthy volunteers, impairment of working memory and if the drug AZD8529 will block the effects of ketamine on working memory as assessed by functional magnetic resonance imaging (fMRI).


Eligibility criteria: Inclusion Criteria:

* Right handed
* 12th grade education or equivalent
* Able to read and write English as primary language

Exclusion Criteria:

* History of head injury
* Substance abuse or dependence
* History of claustrophobia

Primary outcomes:
measure: fMRI
timeFrame: 3
measure: Ketamine Infusion
timeFrame: 3
Secondary outcomes:
measure: Clinician Administered Dissociative States Scale (CADSS)
measure: Positive and Negative Syndrome Scale (PANSS)
measure: Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs, collection of adverse events
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Research Site
state: Connecticut
Study officials:
affiliation: Chair, Department of PsychiatryYale University School of MedicineChief of Psychiatry, Yale-New Haven Hospital
name: John Krystal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00399633: Neuropeptides in the Humane Intra- og Extracerebral Circulation.
Official title: Neuropeptides in the Humane Intra- og Extracerebral Circulation - in Relation to Sumatriptan in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Migraine
Keywords: VIP
PACAP
CGRP
Prostanoids
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
Collaborators: name: Glostrup University Hospital, Copenhagen
name: Bispebjerg Hospital
First posted: 2006-11-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The study aim at examining whether Sumatriptan changes the plasma values of the neuropeptides vasoactive intestinal polypeptide (VIP), calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase activating peptide (PACAP) and the prostanoids 6-keto-PGF1α, and PGE2, PGD2 og PGF2α.

Detailed description: The study is meant to give a better understanding of the basic mechanisms behind migraine, and a better understanding of the effects of sumatriptan on the trigemino vascular system.

The endpoints are changes in the plasma values of the neuropeptides vasoactive intestinal polypeptide (VIP), calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase activating peptide (PACAP) and the prostanoids 6-keto-PGF1α, and PGE2, PGD2 og PGF2α.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* 18-50 years,
* 50-100 kg.
* Fertile women must use birth control.

Exclusion Criteria:

* All primary types of headache
* Daily intake of medicine except birth control
* Pregnancy
* Hypertension
* Hypotension
* other chronic disease

Primary outcomes:
measure: Blood concentration of vasoactive intestinal polypeptide (VIP),
measure: calcitonin gene-related protein (CGRP), pituitary adenylate cyclase
measure: activating peptide (PACAP,) and the prostanoids
measure: 6-keto-PGF1α, PGE2, PGD2 and PGF2α, sampled from different
measure: venous catheters.
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup, Copenhagen
country: Denmark
facility: Danish Headache Center
state: Copenhagen
Study officials:
affiliation: Danish Headache Center
name: Jakob Møller Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04230733: Pelvis Displacement and Gait Indicators in Patient With Lumbar Disc Herniation
Official title: Correlation Analysis of Pelvis Displacement and Gait Indicators in Patient With Lumbar Disc Herniation : Retrospective Study Using Electronic Medical Record Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Disc Herniation
Gait Analysis
Pelvis Abnormal
Keywords: Gait
Pelvic height
Leg Length Discrepancy
Sacral angle
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are admitted to Jaseng Hospital of Korean Medicine and got gait analysis

Brief summary: The purpose of this study is to investigate the correlation between pattern of gait and pelvic displacement in patients with lumbar disc herniation.

Detailed description: Walking is a repetitive movement that moves your body while keeping your posture stable. The pelvis is located between the hip and lumbar region, where many muscles are attached to regulate the movement of the hip and lumbar spine. Asymmetrical pelvic alignment affects stability of the lower extremities and trunk, making normal walking difficult. The purpose of this study is to investigate the pattern of gait according to pelvic displacement in patients with lumbar disc herniation.

Eligibility criteria: Inclusion Criteria:

* Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI
* Patient who got gait analysis

Exclusion Criteria:

* Patients without MRI and X-ray
* Patient diagnosed with ankle disease

Primary outcomes:
measure: Correlation between pelvic displacement and gait parameters
timeFrame: A week after data collected
Secondary outcomes:
measure: Numeric Rating Scale
timeFrame: A week after data collected
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, KMD, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00766233: Optimal Application Dose of Superficial Hyperthermia
Official title: Phase III Study for Analysis of the Optimal Application Dose of Superficial Hyperthermia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tumors
Keywords: Hyperthermia
superficial tumor treatment
superficial tumors
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2008-10-03
Enrollment: 17
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: Hyperthermia - a warming of the tumor at 42-43 ° C - in combination with radiation and / or chemotherapy is a proven method of treatment for malignant tumors. The amplification of the effect of radiotherapy and various chemotherapeutic agents (platinum analogues, nitrogen-Lost derivatives, cytotoxic antibiotics) is experimentally demonstrated. Randomized clinical trials have shown a better chance of survival and better local tumor control without increasing the toxicity of combined treatment especially also in children's tumors. The combination of hyperthermia and radiation therapy is more effective than radiotherapy alone. Hyperthermal temperatures increase blood circulation in tumors as a response to stimulation with heat. Tumor tissue, having a minor circulation and being acidotic, is resistant to radiotherapy, but sensitive to hyperthermia, while tumor with a high blood flow is sensitivity to radiation. This positive interaction is a compelling reason for the combination of hyperthermia and ionized radiation.

Hyperthermia, in combination with chemotherapy, increases the concentration of cytostatics in the tumor region, raising blood flow caused by warmth. In addition, hyperthermia increases toxicity of drugs in cells, being normally resistant to many drugs. Hyperthermia can synergistically be combined with chemotherapy treating "high risk" - tumors with curative intention.

In addition to the clinical use of surface hyperthermia (BSD 500 - O), with appropriate treatment of tumors up to 3 cm deep from the surface of the body with established indications and palliative indication in advanced stages of cancer, a prospective, randomized study with quality-controlled thermometry shall establish the optimal sequence of Hyperthermia in combination with irradiation. Therefore the treatment sequence of once per weeks is compared to a sequence of three times per week.


Eligibility criteria: Inclusion Criteria:

* Surficial tumors (\< 3-4 cm)
* ≥ 18 years
* Karnofsky Index \> 60
* No other treatment in between 30 d, applicable radiation dose min.30 Gy
* Cumulative equivalent minutes 42°C T75

Exclusion Criteria:

* Pregnancy
* Pace maker
* Metal implants

Primary outcomes:
measure: Complete remission (Imaging / clinical)
timeFrame: 5 years
Secondary outcomes:
measure: Progression-free survival, overall survival, Quality of life
timeFrame: 5 years
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Department of Radiotherapy University Hospital Mannheim
Study officials:
References:
Clinical trial NCT01135433: A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Type 2 Diabetic Patients
Official title: A Phase 3 Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes mellitus
Metformin
ASP1941
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-06-02
Enrollment: 168
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and metformin in patients with diabetes mellitus.

Detailed description: This study is to evaluate the efficacy (HbA1c change from baseline) and safety of ASP1941 in combination with metformin in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with metformin alone. The effects of ASP1941 are compared with those of placebo.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients receiving with metformin mono-therapy for at least 6 weeks
* HbA1c value between 7.0 and 9.5%
* Body Mass Index (BMI) 20.0 - 45.0 kg/m2

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Serum creatinine \> upper limit of normal
* Estimated GFR \< 60ml/min/1.73m2
* Proteinuria (albumin/creatinine ratio \> 300mg/g)
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: Baseline and for 24 weeks
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose
timeFrame: Baseline and for 24 weeks
measure: Change from baseline in fasting serum insulin
timeFrame: Baseline and for 24 weeks
measure: Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)
timeFrame: for 52 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.
Clinical trial NCT00949533: A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza
Official title: A Phase IIIb, Open-label, Comparative, Randomized Study on Resistance of Influenza A/H1N1 2009 Virus to Treatment With Oseltamivir at Standard Dose Versus Double Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-07-30
Enrollment: 37
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open-label randomized 2 arm study will determine the emergence of viral resistance in participants with seasonal influenza A infection treated with oseltamivir. Eligible participants less than or equal to (\</=) 5 years of age will be randomized to receive oseltamivir at either standard dose (30-75 milligrams \[mg\] orally twice daily \[bid\]) or double dose (60-150 mg orally bid) for 5 days. Target sample size is greater than (\>) 100.


Eligibility criteria: Inclusion Criteria:

* positive rapid antigen test for influenza A
* onset of symptoms of influenza (fever, at least one respiratory symptom) \</=48 hours

Exclusion Criteria:

* clinical suspicion of infection with a respiratory virus other than influenza
* suspicion of invasive bacterial infection
* evidence of poorly controlled underlying disease
* known immunosuppression
* known allergy to Oseltamivir
* women who are pregnant or planning to get pregnant during the study

Primary outcomes:
measure: Percentage of Participants Excreting Resistant Virus
timeFrame: Day 5
Secondary outcomes:
measure: Percentage of Participants With A Reduction in Viral Load
timeFrame: Baseline, Day 5
measure: Number of Participants With Various Clinical Signs and Symptoms
timeFrame: Day 5
measure: Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected
timeFrame: Day 5
Other outcomes:
Locations:
city: Curitiba
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03428633: Thoracic Paravertebral Blocks in Open Nephrectomy
Official title: Thoracic Paravertebral Blocks in Open Nephrectomy. A Prospective, Randomized Study of Block Efficacy and Influence on Oxidative Stress and Patient Outcome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nephrectomy
Analgesia
Lead sponsor: Asklepieion Voulas General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Michail Tsagkaris
name: Chryssoula Staikou
name: Ioannis Karavokyros
First posted: 2018-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 60 patients ASA I-III, undergoing open nephrectomy will be randomly assigned into one of two groups, namely group A (n=30), where a thoracic paravertebral block will be performed preoperatively and a paravertebral catheter for continuous and patient controlled bolus local anesthetic (ropivacaine) doses will be inserted and group B (n=30) where morphine IV will be administered at the beginning and the end of operation and postoperatively through patient controlled IV doses. NRS scores in static and dynamic conditions, complications, patient satisfaction, oxidative stress (through lactic acid, superoxide dismutase, malondialdehyde) and NGAL pre- and postoperatively, will be recorded.


Eligibility criteria: Inclusion Criteria:

* Physical status according to American Society of Anesthesiologists (ASA) I-III
* Patients scheduled for open nephrectomy

Exclusion Criteria:

* Previous operation on same kidney
* Contraindication of paravertebral block or any of the agents used in the protocol
* BMI above 32
* Any concurrent malignancy not cured
* Serious psychiatric, mental and cognitive disorders
* Block failure
* Chronic pain
* Severe kidney disfunction

Primary outcomes:
measure: Postoperative pain
timeFrame: 48 hours
measure: Oxidative stress - lactic acid (mmol/L)
timeFrame: 24 hours
measure: Oxidative stress - superoxide dismutase (units/ml)
timeFrame: 24 hours
measure: Oxidative stress - malondialdehyde (nmol/mg protein)
timeFrame: 24 hours
measure: Oxidative stress - neutrophil gelatinase-associated lipocalin (NGAL) (ng/ml)
timeFrame: 24 hours
Secondary outcomes:
measure: Complications
timeFrame: 48 hours
measure: Patient satisfaction
timeFrame: 48 hours
measure: Patient mobilization
timeFrame: 7 days
measure: Intestinal function
timeFrame: 7 days
measure: Chronic pain
timeFrame: 6 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Asklepieion Hospital of Voula
Study officials:
References:
Clinical trial NCT03740633: Functional Training for the Prevention of Deep Venous Thrombosis
Official title: The Effects of Post-operative Functional Training on the Prevention of Deep Venous Thrombosis in the Patients of Gynecological Malignancies: A Phase 3 Randomized Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ankle Motion
Gynecologic Neoplasm
Deep Venous Thrombosis
Abdominal Breathing
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 398
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to analyze the post-operative functional training on the prevention of deep venous thrombosis (DVT) in the patients who have accepted major surgeries for the gynecological malignancies. The functional training consists of: (1) active and passive ankle pump motions including flexion and extension, circumduction; (2) abdominal breathing training. The primary end is the incidence of DVT happened 30 days from surgery. The secondary ends include the patients satisfaction about functional training.


Eligibility criteria: Inclusion Criteria:

* Having received major surgeries for gynecologic malignancies
* Good performance status
* Aged 18 years or older
* Signed an approved informed consents
* No injuries to the skin, musculoskeletal system
* No venous thromboembolic disease before surgeries

Exclusion Criteria:

* Not meeting all of the inclusion criteria
* Delayed extubation

Primary outcomes:
measure: deep venous thrombosis
timeFrame: One years
Secondary outcomes:
measure: adverse events
timeFrame: One year
measure: patient satisfaction
timeFrame: One year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: