louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02348229: Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins
Official title: Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins in Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Keywords: Enhanced recovery after surgery
laparoscopic gastrectomy
advanced gastric cancer
C-reactive,visceral proteins
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators designed a prospective randomized, controlled clinical trial then recruited 149 consecutive advanced gastric cancer patients. Further divided into a ERAS group (n=73) and a conventional pathway group (n=76). Surgical technique in both groups was same laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compared outcomes included clinical parameters and serum indicators.

Detailed description: Enhanced recovery after surgery combined with laparoscopic-assisted gastrectomy was successfully carried out in this study. Recovery parameters such as the length of time to return to normal diet,mean hospital stay (d) were recorded.

Eligibility criteria: Inclusion Criteria:

1. Age 18-75 years old
2. Diagnosis confirmed by the endoscopic biopsy and total-body CT scan
3. No history of the chronic renal disease ,chronic liver disease, cardiopulmonary dysfunction, ASA score≦3
4. No neoadjuvant chemotherapy and radiotherapy
5. No digestive obstruction and distant metastasis

Exclusion Criteria:

1. Conversion to open gastrectomy
2. A large amount of bleeding leading(\>500ml)
3. Patients withdrew their consent

Primary outcomes:
measure: Compartition of postoperative hospital stay
timeFrame: up to 30 days after the operation
Secondary outcomes:
measure: Change from baseline in C-Reactive Protein( CRP) and visceral proteins level
timeFrame: baseline and 5 days
Other outcomes:
Locations:
Study officials:
affiliation: The First Hospital of Jilin University
name: Quan Wang, Doctor
role: STUDY_DIRECTOR
References:
citation: Mingjie X, Luyao Z, Ze T, YinQuan Z, Quan W. Laparoscopic Radical Gastrectomy for Resectable Advanced Gastric Cancer Within Enhanced Recovery Programs: A Prospective Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):959-964. doi: 10.1089/lap.2016.0057. Epub 2016 Nov 22.
Clinical trial NCT04246229: Transcutaneous Bilirubinometry and Phototherapy
Official title: Transcutaneous Bilirubinometry in Neonatal Hyperbilirubinemia During and After Phototherapy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neonatal Hyperbilirubinemia
Keywords: transcutaneous bilirubinometry
phototherapy
neonatal icterus
neonatal jaundice
newborn
Lead sponsor: Princess Amalia Children's Clinic
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 130
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A randomized Controlled trial comparing the use of transcutaneous bilirubinometry to serum bilirubin measurements (via blooddraws = standard care) in neonates born after a gestational age \> 32 weeks and \< 15 days of age treated with Phototherapy for neonatal hyperbilrubinemia.

Detailed description: A randomized Controlled trial comparing the use of transcutaneous bilirubinometry to serum bilirubin measurements (via blooddraws = standard care) in neonates born after a gestational age \> 32 weeks and \< 15 days of age treated with Phototherapy for neonatal hyperbilrubinemia. Main outcome measurement is the number of blooddraws for measurement of bilirubin. Secondary outcome measurements are duration of phototherapy and hospitalisation.

Eligibility criteria: Inclusion Criteria:

* Neonates with indication for phototherapy for treatment of hyperbilirubinemia

Exclusion Criteria:

* skinlesions located on the sternum interfering with transcutaneous measurement
* exchange transfusion

Primary outcomes:
measure: blood draws
timeFrame: during hospitalisation with a maximum of 14 days
Secondary outcomes:
measure: phototherapy duration
timeFrame: during hospitalisation with a maximum of 14 days
measure: hospitalisation
timeFrame: 3 months
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Klinieken
state: Overijssel
Study officials:
affiliation: 1971
name: Jolita Bekhof, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03588429: The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics
Official title: The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Keywords: Sevoflurane
Isoflurane
Lead sponsor: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of sevoflurane and isoflurane at equi-minimum alveolar concentration using EEG analysis.

Detailed description: Anesthetic agents vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different spectral entropy or bispectral index values. However, there is no study that demonstrate the difference between analgesic potency of volatile anesthetics. The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of sevoflurane and isoflurane at equi-minimum alveolar concentration using EEG analysis.

Eligibility criteria: Inclusion Criteria:

* patients undergoing general anesthesia using volatile anesthetics and intubation
* patients with american society of anesthesiologist physical status I, II
* patients obtaining written informed consent

Exclusion Criteria:

* patients with a history of any psychiatric or neurological disease
* patients who had received any medication affecting the central nervous system
* patients who had received medication affecting the sympathetic or parasympathetic nervous systems
* patients undergoing supraglottic airway for airway management
* pregnant women

Primary outcomes:
measure: qCON index
timeFrame: the 10 min at steady-state anesthesia after endotracheal intubation
Secondary outcomes:
measure: qNOX index
timeFrame: the 10 min at steady-state anesthesia after endotracheal intubation
Other outcomes:
Locations:
city: Cangzhou
country: China
facility: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
state: Hebei
Study officials:
affiliation: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
name: Ruizhao Lv, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01028729: A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)
Official title: A Study of Endostar in Combination With Chemotherapy Followed by Endostar Maintenance Therapy in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: Simcere Pharmaceutical Co., Ltd
Sponsor class: OTHER
First posted: 2009-12-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the safety and efficacy of Endostar combined with chemotherapy (Gemcitabine plus Platinum-based chemotherapy) followed by Endostar maintenance therapy in patients with stage IIIB/IV non-small cell lung cancer (NSCLC).

Detailed description: All eligible patients will receive Endostar in combination with Gemcitabine plus Platinum-based chemotherapy for 4 cycles (21 days for each cycle). Endostar treatment will continue after completion of chemotherapy cycles until disease progression. Efficacy will be evaluated every two cycles.

Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of inoperable stage IIIB/IV NSCLC
* At least one measurable lesion
* Age of 18-75 years
* Life expectancy \> 3 months
* ECOG performance status 0-2
* Adequate hematologic, renal, and hepatic function

Exclusion Criteria:

* Prior systemic chemotherapy for NSCLC
* Evidence of any unstable diseases (serious infection, grade 4 hypertension, unstable angina, congestive heart-failure, compromised renal or hepatic function, nonhealing wound or bone fracture)
* Concurrent anticoagulation therapy
* Evidence of bleeding diathesis or coagulopathy
* Pregnant or lactating women
* Allergic to E.coli preparation

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: July 2011
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: July 2011
measure: Clinical Benefit Response (CBR)
timeFrame: July 2011
measure: Overall Survival (OS)
timeFrame: July 2011
measure: Survival Rate
timeFrame: one year
measure: Adverse Events
timeFrame: July 2011
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Yiping Zhang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05394129: Diagnostic Accuracy of SurePath™ in EUS-FNA
Official title: A Prospective Comparison of SurePath™ Liquid -Based Cytology and Conventional Smear Cytology in Endoscopic Ultrasound-guided Sampling of Esophageal, Gastric, Duodenal Subepithelial Tumors, Periesophageal and Perigastric Lymph Nodes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Submucosal Tumor of Gastrointestinal Tract
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 89
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients above 19 years of age who underwent EUS-FNA for suspected esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes.

Brief summary: It is a prospective randomized controlled study to evaluate the diagnostic accuracy of SurePath™ liquid-based cytology in endoscopic ultrasound-guided sampling.

Detailed description: The SurePath™ has been approved by the FDA since 1997. Investigators want to compare the diagnostic accuracy of SurePath™ liquid based cytology and conventional smear cytology(CSC) in EUS-FNA sampling of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes.

The investigators randomly assigned (1:1) patients to the SurePath™ group or the CSC group. Aspirates from the first needle pass were processed by one method, aspirates from the second pass by the other method, and specimens from the last pass were processed as core biopsy samples. The primary endpoint was the diagnostic efficacy of each method, with the final diagnosis as the gold standard. The aim of this study is to confirm that the SurePath™ is not inferior than the conventional smear test.

Eligibility criteria: Inclusion Criteria:

* Patients who signed the agreement after the explanation
* Patients suspected of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes from radiological(CT, MR, ultrasound) or endoscopic examinations.

Exclusion Criteria:

* Those who did not agree with the study
* Patients younger than 19 years of age
* Serious mental patients
* Patients with severe accompanying diseases (ESRD, advanced COPD, severe heart failure, sever mental illness)
* Pregnant women
* If EUS is difficult due to previous surgery (Billroth II or TG with R-en-Y)
* Patient with blood clotting abnormality
* If there is a risk of tract seeding after examination

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Cytomorphologic feature
timeFrame: 6 months after randomization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Fellowship
name: Han Myung Lee, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02644629: Intra-nasal vs. Intra-venous Ketamine Administration
Official title: Intra-nasal vs. Intra-venous Ketamine Administration as an add-on to Antidepressant Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study wishes to contribute to the applicability of the use of ketamine in a clinical setting by focusing on the efficacy of intra-nasal administration compared with the IV route.


Eligibility criteria: Inclusion Criteria:

1. Age 18-65
2. Diagnosis of MDD (Major Depressive Disorder), made or affirmed by a senior psychiatrist in Shalvata
3. MADRS score \> 20
4. Treated with conventional anti-depressant, administered within a formal psychiatric clinic or by a certified psychiatrist.

Exclusion Criteria:

1. Active or past psychotic disorder, including a history of psychotic affective state
2. Mental Retardation or Autistic Spectrum Disorder
3. Prominent personality disorder
4. Cardiac or neurologic active medical condition, including past CVA/TIA (Cardiovascular Accident/Transient Ischemic Attack) or any other unstable medical condition.
5. Chronic nasal congestion
6. Active or recent drug or alcohol abuse
7. Substantial suicidality in a patient requiring admission but refuses to do so, and signs an "against medical advice" release form as part of clinical evaluation, and does not answer the terms for involuntary admission.

Primary outcomes:
measure: MADRS (Montgomery-Åsberg Depression Rating Scale) score improvement from baseline
timeFrame: 15 weeks
Secondary outcomes:
measure: Ratio of subjects achieving remission
timeFrame: 15 weeks
measure: Ratio of subjects achieving Response
timeFrame: 15 weeks
measure: Durability of anti-depressant effect according to MADRS Score
timeFrame: 15 weeks
measure: Tolerability of Route, based on side effects questionnaire
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata MHC
Study officials:
affiliation: Shalvata MHC
name: Aviv Segev, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00783029: Measurement of the Eye's Blood Vessels Using the Dynamic Vessel Analyzer (DVA)
Official title: Reproducibility of Dynamic Vessel Analyzer Measurements and Establishment of Standards
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Vasodilation
Vessel Reactivity
Dynamic Vessel Analyzer
Retina
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 87
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Subjects

Brief summary: The purpose of this research study is examine the response of the blood vessels in the eye to a light flicker stimulus using the Dynamic Vessel Analyzer (DVA) on two separate days in healthy individuals. The DVA uses an instrument which is used during routine eye examinations. The hypothesis of the study is that the changes in eye's blood vessel will be similar between the two visits; thus establishing reproducibility of the measurements for future comparisons to individuals with stroke or heart disease. In addition, this study will compare the eye's blood vessel responses to responses of the blood vessels in the arm using Doppler ultrasound.

Detailed description: Retinal blood vessels have been suggested to be an index of the cerebral and coronary microvasculature function. Since the retinal vessels are not under direct sympathetic control, this vascular bed is an ideal location to examine local mechanisms of vascular regulation(i.e. metabolite/endothelial and myogenic). Based on previously published data on animal and human responses, the central purpose for the proposed research is to compare the retinal and brachial vasodilatation responses in healthy subjects using the Dynamic Vessel Analyzer (DVA). Our rationale for this proposal is to better understand retinal blood flow in healthy individuals, gain insight into vascular reactivity in different vascular beds, and lastly to establish standards and reproducibility of DVA Measurements.

Eligibility criteria: Inclusion Criteria:

* Healthy Individuals
* Age: 21 to 65 years
* Non-smokers
* Non-obese

Exclusion Criteria:

* History of cardiovascular, pulmonary, peripheral vascular disease, renal, prostate, and urinary retention disease; Hypertension; Narrow angle Glaucoma or Age Related Macular Degeneration.
* Pregnancy
* Inability to fixate using eye device
* Does not wish to participate

Primary outcomes:
measure: To characterize changes in the diameter of retinal blood vessels to a light-induced flicker stimulus in healthy subjects on two separate visits.
timeFrame: 1 Year
Secondary outcomes:
measure: To compare retinal vasodilator responses to brachial reactive hyperemic responses.
timeFrame: 1 Year
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Kerstin Bettermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00628329: Vitamin A, Its Receptors and Asthma
Official title: Vitamin A, Its Receptors and Asthma: Vitamin A Levels in Serum and Expression and Responsiveness of Vitamin A Receptors in Circulating Mononuclear Cells of Asthmatics
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Asthma
Keywords: asthma, retinol, cis-retinoic acid
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2008-03-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female Age 18-64

Brief summary: We wish to understand the association of Vitamin A serum levels and Vitamin A receptor number and responsiveness in asthmatics. We believe that Vitamin A receptors may be less prevalent in asthmatics and their responsiveness decreased.

Detailed description: We wish to define the association of asthma, vitamin A serum levels and vitamin A receptor number and responsiveness on circulating mononuclear cells. Asthma is a complex, heterogenous and often debilitating and potentially deadly disease. The causes for asthma are many, with susceptibility and resistance to treatment is poorly understood. Ultimately, looking at this disease from another angle such as the role of Vitamin A and/or receptors can help us learn more about the pathophysiology and treatment of asthma.

Eligibility criteria: Inclusion Criteria:

* Patients with previously diagnosed asthma on inhaled corticosteroids, systemic steroids and/or long acting beta agonist (for a period of 6 mo to 5 years)
* Age 18-64
* Male or female

Exclusion Criteria:

* Children under age 18
* Adults 65 or older
* Patients with COPD

Primary outcomes:
measure: Retinol levels in blood, flow cytometric study of the RXRRAR receptors before and after addition of ATRA, 9-cis-RA and steroid
timeFrame: 2-4 weeks after blood sample drawn
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Daniel Stechschulte, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04433429: Nutraceuticals and Vascular Remodelling
Official title: Lipid Profile and Vascular Remodelling in Young Dyslipidemic Subjects Treated With Nutraceuticals Derived From Red Yeast Rice.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Keywords: Atherosclerosis
Carotid
Lipid profile
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with mild hypercholeterolemia and low-to moderate cardiovascular risk profile

Brief summary: Aim of the study is to assess the effect of a long-term nutraceutical multitarget approach on lipid profile, inflammatory mediators and vascular remodeling in primary cardiovascular prevention in a setting of controlled dietary habits. The nutraceutical combination used in this study consists of a single pill containing 333 mg of RYR, equivalent to 10 mg of Monacolin K, and 30 mg of Coenzyme Q10 (CoQ10).


Eligibility criteria: Inclusion Criteria:

* Total Cholesterol \> 150 mg/dl and \< 250 mg/dl;
* Triglycerides \> 150 mg/dl and \< 500 mg/dl;
* Fasting glucose \< 126 mg/dl;
* Stable antihypertensive treatment (at least for 6 months) in presence of hypertension.

Exclusion Criteria:

* Total Cholesterol \> 250 mg/dl
* Triglycerides \> 500 mg/dl
* Previous statin therapy (last 6 months);
* Treatment with hypoglycemic agents and/or fasting glucose \> 126 mg/dl;
* Chronic gastrointestinal disorders;
* Chronic kidney disease (eGFR \< 60 ml/min/1.73 m2);
* Concomitant treatment with drugs potentially interfering with glucose and lipid metabolism; - History of cardiovascular diseases;
* Proven intolerance to any component of the nutraceutical product;
* Pregnancy or breastfeeding.

Primary outcomes:
measure: Change from baseline in cholesterol levels at one year
timeFrame: Baseline and one year
measure: Change from baseline in carotid intima media thickening at one year
timeFrame: Baseline and one year
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
Study officials:
References: