louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01677728: Effect of Target Therapy on Patients Undergoing Synchronic Hepatectomy for Colorectal Liver Metastases
Official title: A Randomized, Controlled Trial of Target Therapy Plus Chemotherapy in Patients Undergoing Liver Resection for Colorectal Liver Metastases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Liver Tumor
Keywords: colorectal liver metastases
chemotherapy
cetuximab
bevacizumab
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Fudan University
First posted: 2012-09-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From Zhongshan hospital

Brief summary: The aim of this study is to explore whether target therapy in combination with chemotherapy as treatment could improve survival or tumor response in patients undergoing Synchronic Hepatectomy for Colorectal Liver Metastases.

Detailed description: In patients with colorectal cancer (CRC), the liver is the most common site of hematogenous metastases. Approximately half of patients develop hepatic metastases during the course of the disease, and hepatic metastases are responsible for death in at least two thirds of CRC patients.

Over the past decade, due to the introduction of irinotecan-based or oxaliplatin-based combination chemotherapy, the median survival among patients with colorectal liver metastases (CLM) has increased from 6 \~8 months to more than 20 months5.In recent years, target therapy has rapidly gained attention for the treatment of CLM and is under active investigation.

Although numerous publications have reported the efficacy of target therapy in combination treatment for CLM patients, most of these studies focused solely on those patients without undergoing resection of liver metastases. In contrast, little work has concentrated on exploring the effection of target therapy for CLM patients undergoing Synchronic Hepatectomy.

Eligibility criteria: Inclusion Criteria:

* age between 18 - 75 years old
* Performance status (ECOG) 0\~1
* colorectal adenocarcinoma pathologically
* without any chemotherapy or radiotherapy
* liver metastases undergoing radical resection
* colorectal cancer undergoing radical resection
* no other metastases
* suitable for chemotherapy
* agreed by patients

Exclusion Criteria:

* age below 18 years old or greater than 75 years old
* haven't pathological diagnosis of colorectal adenocarcinoma with liver metastase
* with any chemotherapy or radiotherapy
* with other metastasis
* unresectable colorectal cancer or liver metastases
* unsuitable for chemotherapy or target therapy
* not agreed by patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Xu Jianmin, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02712528: Recovery Profiles of Remifentanil-based Regimen for Cardiac Surgery
Official title: Recovery Profiles of Remifentanil-based vs. Sevoflurane-sufentanil Combined Regimen for Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Surgery
Keywords: bispectral index
extubation
recovery
remifentanil
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 43
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Backgrounds: Monitoring of Bispectral index (BIS) has been regarded as useful to determine the degree of intraoperative hypnosis. Major factors of postoperative recovery after cardiac surgery include patient's recovery in cognitive function from the postoperative residual effects of anesthetics, such as opioids and sedatives, administered during intraoperative period. Therefore employing anesthetic regimens which can provide earlier recovery in cognitive function would be beneficial in facilitating fast-track cardiac surgery with earlier postoperative extubation and discharge from the intensive care unit (ICU).

Previous investigations suggested efficacy of BIS in evaluating the degree of postoperative hypnosis in the ICU.

The present study compares the time for reaching BIS greater than 80 after using 2 different anesthesia regimens for cardiac surgery, remifentanil-based regimen and sevoflurane-sufentanil balanced regimen.

Analyzing the changes immediately after cardiac surgery would be useful to determine the degree of patient's postoperative emergence.

Materials and Methods:

During study period, patients undergoing elective cardiac surgery in Konkuk University Medical Center are randomly assigned to get remifentanil-based regimen consisting of remifentanil 0.75 mcg/kg/min and supplemental propofol for maintaining BIS 40-60 (Group R) or sevoflurane (end-tidal 1.2-2.8 vol%) and sufentanil (0.015 mcg/kg/min) balanced regimen in Group S.

All patients get intravenous patient controlled anesthesia consisting of alfentanyl and ondansetron after surgery. Supplemental remifentanil 0.25-0.3 mcg/kg/min is administered during postoperative 2 hours in Group R.

As a primary objective, inter-group difference in the time for achieving BIS greater than 80 is determined.


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective coronary artery bypass surgery

Exclusion Criteria:

* combined valve surgery
* preoperative intraaortic balloon pumping
* preoperative low cardiac output syndrome
* chronic obstructive pulmonary disease

Primary outcomes:
measure: Time to reach BIS > 80
timeFrame: 1 minute
Secondary outcomes:
measure: Extubation time
timeFrame: 1 minute
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Tae-Yop Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02512328: Improvement of Colonoscopy Preparation by New Media (APP)
Official title: First Experiences With an Offline App (SPA; Smartphone Application) for Colonoscopy Preparation- PERICLES-I APP; Prospective Evaluations of Improvement of Colonocopy Preparation by Optimized Visualization (PERICLES)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Gastrointestinal Neoplasms
Keywords: Colonoscopy
new media
APP
colonoscopy preparation
SPA
smartphone application
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2015-07-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Feasibility of an newly programmed offline application for smartphones (SPA, APP) for colonoscopy preparation offering a 5 day guidance prior colonoscopy containing dietary- and behavioral recommendation.

Detailed description: First feasibility testing of a newly programmed app/SPA for android system named Colopr-APP. It is an strictly offline working, autonomous system downloaded to the smartphone. It creates an 5-day guidance prior outpatient colonoscopy with dietary and behavior recommendations.

Eligibility criteria: Inclusion Criteria:

* outpatient colonoscopy
* smartphone owner with android system

Exclusion Criteria:

* chronic renal failure
* anticoagulants
* pregnancy
* diabetes mellitus (IDDM)

Primary outcomes:
measure: Feasibility
timeFrame: at day 0 colonoscopy after colonoscopy preparation
Secondary outcomes:
measure: Bowel preparation
timeFrame: at day 0 after colonoscopy
measure: patient´s satification
timeFrame: day 1 after colonoscopy
Other outcomes:
Locations:
city: Munich
country: Germany
facility: 2nd Medical Department, Klinikum rechts der Isar
Study officials:
affiliation: Physician
name: Benjamin M Walter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walter B, Schmid R, von Delius S. A Smartphone App for Improvement of Colonoscopy Preparation (ColoprAPP): Development and Feasibility Study. JMIR Mhealth Uhealth. 2017 Sep 20;5(9):e138. doi: 10.2196/mhealth.7703.
Clinical trial NCT02921828: A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg
Official title: Pomalyst®Capsules Special Use-results Surveillance (All-case Surveillance)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Pomalyst
Teratogenicity
bone marrow suppression
thromboembolism
peripheral neuropathy
infection
tumour lysis syndrome
somnolence
depressed level of consciousness
confusion
fatigue
dizziness
acute renal failure
heart failure
arrhythmia
interstitial pneumonia
hypersensitivity
hepatic function disorder
jaundice
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2016-10-03
Enrollment: 1149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.

Brief summary: 1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form of the surveillance will be completed at the time when the planned number of patients to be enrolled is reached. During a period until conditions for approval are removed, a system enabling to retrospectively collect appropriate information based on patient data from RevMate® will be, as necessary, maintained.
2. Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst


Eligibility criteria: Inclusion Criteria:

* Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Adverse event (AE)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: No City Provided
country: United States
facility: Local Institution - Japan
state: New Jersey
city: Kobe
country: Japan
facility: Shinko Hospital
state: Hyogo
Study officials:
affiliation: Celgene
name: Jinshu Cho
role: STUDY_DIRECTOR
References:
Clinical trial NCT04747028: Effect of Malnutrition on Primary and Permanent Dentation
Official title: Effect of Malnutrition on Primary and Permanent Dentition a Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Study Focus on the Effect of Malnutrition and Dental Problem
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adolescent diagnosed with malnutrition in the past or presnt time.patient should not suffer from any other systemic disease

Brief summary: The caries index delayed eruption and enamel malformation will recorded for a 2 group of participants

Detailed description: The participants suffering from malnutrition will be divided into age group from 4 to 6 to study the primary dentition and another group age from 13 to 16to study the primary dentition caries index with dmf and DMF score Modified DDE index for measurement of developmental defects in enamel

Eligibility criteria: Inclusion Criteria:

* parent accept to sign the informed consent Participants not suffering from any other systematic disease

Exclusion Criteria:

* non coopreative patient Suffering from systematic disease

Primary outcomes:
measure: Caries index
timeFrame: 1month
Secondary outcomes:
measure: E amel malformation
timeFrame: 1month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01832428: A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cell for the Treatment of Stroke.
Official title: A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cell for the Treatment of Stroke. It is Self Funded (Patients' Own Funding) Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Stroke,
Lead sponsor: Chaitanya Hospital, Pune
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is single, centre trial to study the safety and efficacy of Bone marrow derived autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of Body and face

Detailed description: This study is single centre trial to study the safety and efficacy of Bone marrow derived autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of Body and face

Eligibility criteria: Inclusion Criteria:

* Patient should suffer from stroke due to cerebral infarct or Haemorrhage or accelerated hypertension.
* willingness to undergo bone marrow derived autologous cell therapy.
* patient those provide fully Informed consent form for the study.
* Ability and willingness to regular visit to hospital and follow up during the protocol Procedure.

Exclusion Criteria:

* Patients with pre - existing or Current systemic disease such as lung , liver ( exception; History of uncomplicated Hepatitis A),gastrointestinal, Cardiac , Immunodeficiency,(including HIV) Or laboratory Investigation that could cause a neurological defect.History of Life threating Allergic or immune- mediated reaction.
* Alcohol and drug abuse / dependence.
* Severe skin infection.
* Haemodynamically unstable.
* subject with primary and secondary diabetes , Insulin depenence,

Primary outcomes:
measure: Improvement in power of Body and facial Muscles
timeFrame: 6 Months
Secondary outcomes:
measure: Improvement in Walking Ability
timeFrame: 6 months
measure: Improvement In Speech and cognition
timeFrame: 6 Months
measure: Improvement in Vision in both eyes
timeFrame: 6 month
Other outcomes:
Locations:
city: Pune
country: India
facility: Chaitanya Hospital
state: Maharashtra
Study officials:
affiliation: CHAITANYA HOSPITAL
name: ANANT E BAGUL, M.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02242461: Rhodiola Crenulata as an Adjunctive Therapy in COPD
Official title: Rhodiola Crenulata as an Adjunctive Therapy in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COPD
Keywords: COPD, Rhodiola L., clinical trial, biomarkers, spirometry
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 57
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesize that add-on Rhodiola L extract capsule to the regimen of patients with moderate-to-severe COPD (1) may provide a potential of systemic effects of anti-inflammation and anti-oxidation for these patients, and these effects (2) may reflect in the improvement of patients' physiological measurements, quality of life and exercise tolerance.

Detailed description: This is a single center, randomized, double-blind, placebo controlled clinical trial.

Eligibility criteria:

1. moderate-to-severe COPD patients
2. aged 40-80 years,
3. abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,
4. no acute exacerbation of COPD,
5. clinically being stable for one month and longer,
6. not undergoing exercise training program.

Primary endpoint:

six-minute walk distance in meters at week 12.

Eligibility criteria: Inclusion Criteria:

1. moderate-to-severe COPD patients
2. aged 40-80 years,
3. abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,
4. no acute exacerbation of COPD,
5. clinically being stable for one month and longer,
6. not undergoing exercise training program.

Exclusion Criteria:

1. uncontrolled diabetes mellitus by plasma fasting sugar \>200 mg/dl,
2. uremia or CKD stage 5,
3. chronic heart failureby NYFC III,
4. cerebrovascular disease,
5. uncontrolled anemia by Hb \< 10 mg/dl,
6. active malignant diseases,
7. other hospitalized acute illness,
8. systemic prednisolone \> 10 mg per day.

Primary outcomes:
measure: six-minute walk distance in meters at week 12.
timeFrame: 12 weeks
Secondary outcomes:
measure: mid-arm circumference and triceps skin thickness, Borg scale, COPD assessment test score, St. George Respiratory disease questionnaire, hospital anxiety and depression scale(HADS) and maximum cardiopulmonary exercise test
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taiwan
country: Taiwan
facility: Department of Critical Care Medicine and Division of Pulmonary Medicine
state: Ming-Lung Chuang
Study officials:
affiliation: Department of Critical Care Medicine and Division of Pulmonary Medicine
name: Ming Lung Chuang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chuang ML, Wu TC, Wang YT, Wang YC, Tsao TC, Wei JC, Chen CY, Lin IF. Adjunctive Treatment with Rhodiola Crenulata in Patients with Chronic Obstructive Pulmonary Disease--A Randomized Placebo Controlled Double Blind Clinical Trial. PLoS One. 2015 Jun 22;10(6):e0128142. doi: 10.1371/journal.pone.0128142. eCollection 2015.
Clinical trial NCT03121261: The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During Spinal Anesthesia
Official title: The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During and After Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Inguinal Hernia
Spinal Anesthesia
Keywords: levobupivacaine
nerve fibers
clonidine
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2017-04-20
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: TREATMENT

Brief summary: The cutaneous silent period is a non-invasive technique that gives insight into the function of thin A delta fibers and as such can be a complement to conventional electrophysiological methods used to study the peripheral nerves. Clonidine is a selective partial agonist of the alpha-2 receptors which, added intrathecally to levobupivacaine, enhances the effect of a local anesthetic, prolongs sensory and motor block during local anesthesia and extends the length of post-operative analgesia. It is believed that clonidine achieves this effect by activating the postsynaptic alpha-2 receptors in the gelatine substance of the spinal cord and blocking the conduction of A-delta and C fibers. The aim of the study is to examine functional changes of Aδ - fibers during the application of spinal anesthesia by measuring the cutaneous slinet period and compare the effect of intrathecal administration of a combination of local anesthetic and clonidine in the quiet skin period in relation to the application of local anesthetic only.


Eligibility criteria: Inclusion Criteria:

ASA one and two status BMI 18,5 to 24

Exclusion Criteria:

Coagulation disorders Polyneuropathy Diabetes mellitus Alcoholism Systemic inflammatory and malignant diseases Stroke

Primary outcomes:
measure: 4 Item Duration of Latency and duration of the cutaneous silent period
timeFrame: 24 hours perioperative
Secondary outcomes:
measure: Duration of motor block
timeFrame: 24 hours perioperative
measure: Duration of sensory block
timeFrame: 24 hours perioperative
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
Study officials:
References:
citation: Inghilleri M, Cruccu G, Argenta M, Polidori L, Manfredi M. Silent period in upper limb muscles after noxious cutaneous stimulation in man. Electroencephalogr Clin Neurophysiol. 1997 Apr;105(2):109-15. doi: 10.1016/s0924-980x(97)96579-6.
citation: Mota IA, Fernandes JB, Cardoso MN, Sala-Blanch X, Kofler M, Valls-Sole J. Temporal profile of the effects of regional anesthesia on the cutaneous reflexes of foot muscles. Exp Brain Res. 2015 Sep;233(9):2587-96. doi: 10.1007/s00221-015-4329-2. Epub 2015 May 30.
citation: Uncini A, Kujirai T, Gluck B, Pullman S. Silent period induced by cutaneous stimulation. Electroencephalogr Clin Neurophysiol. 1991 Oct;81(5):344-52. doi: 10.1016/0168-5597(91)90023-q.
Clinical trial NCT05108961: Evaluation of the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)
Official title: Randomized Propective Study Evaluating the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupuncture
Healthy Volunteers
Lead sponsor: Elsan
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
name: Clinique saint martin Pessac
First posted: 2021-11-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To be able to have data on brain activity during an acupuncture session, this pilot study is necessary to evaluate the kinetics of the bispectral index. This research aims to evaluate the kinetics of the bispectral index in healthy volunteers during an acupuncture session, Sham acupuncture or resting in a lying position.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer
* Over 18 years old and less than 65.
* Having given his express consent
* Affiliated to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

* Medical history of psychiatric disorders
* Psychotropic treatment
* narcolepsy
* Obstructive sleep apnea syndrome
* Symptoms that may correspond to COVID 19
* Nickel allergy
* Refusal to participate in the study
* Protected subjects : Adults under guardianship, curatorship or other legal protection deprived of their liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman
* Subject hospitalized without consent

Primary outcomes:
measure: Bispectral Index
timeFrame: 35 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Pessac
country: France
facility: Clinique Saint Martin
Study officials:
References: