louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04143191: Sorafenib Plus TACE Versus Sorafenib Alone as Postoperative Adjuvant Treatment for Resectable Primary Advanced HCC
Official title: Sorafenib Plus Transarterial Chemoembolization Versus Sorafenib Alone as Postoperative Adjuvant Treatment for Resectable Primary Advanced Hepatocellular Carcinoma: A Phase 3, Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 158
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: PREVENTION

Brief summary: This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of Sorafenib combined with transarterial chemoembolization as adjuvant treatment for resectable advanced hepatocellular carcinoma, compared with Sorafenib alone. The primary endpoint is recurrence-free survival. This trial planned to recruit 158 patients who received curative hepatic resection with resectable advanced hepatocellular carcinoma. The patients will be randomized into Sorafenib group and Sorafenib+TACE group as 1:1 ratio.


Eligibility criteria: Inclusion Criteria:

1. Primary hepatocellular carcinoma without any treatments.
2. Received curative hepatic resection
3. ECOG score 0-1
4. Child-Pugh grade A
5. Sufficient liver and kidney function

Exclusion Criteria:

1. Diffused lesions; tumor thrombosis in SMV or IVC.
2. Extra-hepatic metastasis.
3. Contraindication of TACE, like portal-systemic shunt, obvious atherosclerosis, etc.
4. Allergic to the contrast agent of TACE
5. Dysfunction of liver, kidney or bone marrow.
6. Concomitant other malignant tumor or HIV infection

Primary outcomes:
measure: Recurrence-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Time to recurrence
timeFrame: 2 years
measure: Severe adverse events
timeFrame: 2 years
measure: Quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT04339491: Physical Activity During Social Isolation
Official title: What Are the Factors That Affect the Physical Activity Levels of Young Adults During Social Isolation Due to Coronavirus?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Social Isolation
Keywords: physical activity
young adult
coronavirus
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 1206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Young Adults from Community Sample

Brief summary: The aim of the study is to evaluate the physical activity level and the factors affecting physical activity among young adults who are socially isolated due to coronavirus.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-50
* Being volunteer

Exclusion Criteria:

* Being unable to communicate in Turkish
* Not knowing read and write in Turkish

Primary outcomes:
measure: Exercise Habit and Factors Affecting Exercise Attendance
timeFrame: The assessment will be made once at baseline, data collection will be completed up to 6 weeks.
Secondary outcomes:
measure: International Physical Activity Questionnaire - Short Form (IPAQ-SF)
timeFrame: The assessment will be made once at baseline, data collection will be completed up to 6 weeks.
measure: Exercise Benefits/Barriers Scale
timeFrame: The assessment will be made once at baseline, data collection will be completed up to 6 weeks.
measure: The Pittsburgh Sleep Quality Index
timeFrame: The assessment will be made once at baseline, data collection will be completed up to 6 weeks.
measure: The Hospital Anxiety and Depression Scale
timeFrame: The assessment will be made once at baseline, data collection will be completed up to 6 weeks.
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Özge Ertan
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ayşe Zengin Alpözgen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01436591: Comparison of Diagnostic Performance of an Algorithm and a High Definition Classical Iterative Algorithm Positron Emission Tomography (PET) to 18Fluoro-deoxy-glucose (18FDG) in the Evaluation of Axillary Lymph Node Invasion of Breast Tumors
Official title: Comparison of Diagnostic Performance of an Algorithm and a High Definition Classical Iterative Algorithm Positron Emission Tomography (PET) to 18Fluoro-deoxy-glucose (18FDG) in the Evaluation of Axillary Lymph Node Invasion of Breast Tumors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: Cancer
Breast
18FDG
Axillary
Positron Emission Tomography
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2011-09-19
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preoperative assessment of breast cancer.

Brief summary: The primary endpoint of this study is to show that this algorithm in high definition is superior to the classical algorithm in the diagnosis of lymph node metastases.


Eligibility criteria: Inclusion Criteria:

* Informed consent and signed by the patient
* Age ≥ 18 years
* Breast tumor for which the therapeutic indication for surgery has from the outset: breast surgery (conservative or radical) associated with a conventional axillary dissection
* Proof of infiltrating ductal carcinoma histology
* No known metastasis
* No cons-indication to anesthesia.

Exclusion criteria:

* History of neoadjuvant therapy
* Patients with invasive lobular carcinoma
* Indication of the use of sentinel node (if invasive carcinoma uni-centric, ≤ 2 cm in diameter, without palpable lymphadenopathy (N0))
* Diabetes is not controlled by conventional treatment (blood glucose\> 1.8 g / l)
* Inability to capital
* Patients who are pregnant or nursing or of childbearing potential and not using adequate contraception
* Persons deprived of their liberty
* Major subject of a measure of legal protection or unable to consent
* Refusal to participate

Primary outcomes:
measure: Performance of FDG-PET for the evaluation of nodal status
timeFrame: 3 years
Secondary outcomes:
measure: Information on lymph node status in patients with breast cancer.
timeFrame: 3 years
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
affiliation: Centre François Baclesse
name: SWITSERS Odile, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05573191: Effects of Intravenous Lidocaine on ED50, ED95 and NTI Values of Propofol Induced Unconsciousness
Official title: Effects of Intravenous Lidocaine on ED50, ED95 and NTI Values of Propofol Induced Unconsciousness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: General Anesthesia
Keywords: ED50
ED95
intravinious lidocaine
propofol
NTI
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 100
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 effect of intravenous lidocaine on ED50 and ED95 of propofol, which causes unconsciousness, is unclear. In addition, it is not clear whether the depth of anesthesia induced by propofol changes when lidocaine is used in combination. Therefore, the purpose of this study was to study the effects of intravenous lidocaine on ED50, ED95 and NTI values of propofol induced unconsciousness .

Detailed description: Intravenous lidocaine has many advantages in perioperative period, in addition to reducing the amount of opioids and propofol, thus reducing the incidence of adverse reactions caused by them, it also has the effect on organ protection, can shorten the length of hospital stay, and promote postoperative recovery. The effect of intravenous lidocaine on ED50 and ED95 of propofol, which causes unconsciousness, is unclear. In addition, it is not clear whether the depth of anesthesia induced by propofol changes when lidocaine is used in combination. Therefore, the purpose of this study was to study the effects of intravenous lidocaine on ED50, ED95 and NTI values of propofol induced unconsciousness .

Eligibility criteria: Inclusion Criteria:

1. The informed consent is signed
2. Aged 18 to 65 years old
3. ASA is rated from I to II
4. Body mass index ranged from 18.5 to 24.9 kg/m2

Exclusion Criteria:

1. Unwilling to sign informed consent or refuse to participate in the study
2. Patients with serious arrhythmia and organic heart disease before surgery
3. Sedative and analgesic drugs were taken within 1 week before surgery
4. Lidocaine allergy
5. Patients with mental and neurological diseases
6. Patients with difficult airway
7. People with hearing impairment

Primary outcomes:
measure: The number of patients with loss of consciousness
timeFrame: 6 hours
Secondary outcomes:
measure: Effects of intravenous lidocaine on NTI values of propofol induced unconsciousness
timeFrame: 6 hours
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Yinchuan
country: China
facility: GuiMei Ji
state: Ningxia
Study officials:
affiliation: General Hospital of Ningxia Medical University
name: Guimei Ji, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05362591: Anterior Resin Bonded Restorations for Adolescent
Official title: Biomimetic Anterior Resin Bonded Restorations for Adolescent Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Missing Teeth
Keywords: missing incisors
resin bonded bridge
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: a 24 Patients above 12 years old with missing upper incisor were divided into two groups, group 1: 12 patient will be treated by resin bonded bridge (RBB) with no preparation protocol, group 2: 12 patient will be treated by resin bonded bridge (RBB) with minimal preparation protocol.

(RBB) retention/survival, patient's speech as well as thermal sensitivity and patient's satisfaction will be evaluated for 12 month at 3,6,9 and 12 month.


Eligibility criteria: Inclusion Criteria:

1. 12-18 years old
2. Full set of permanent teeth.
3. Missing upper incisor
4. Controlled dental disease - no active caries or periodontal diseases
5. Patients will be available to be clinically reviewed up to 1 year

Exclusion Criteria:

1. Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing).
2. Patients with teeth missing opposite to the planned RBB
3. Abutment tooth mobility of 2 or greater (Millers classification)
4. Patients with debilitating illnesses or complicating medical conditions
5. Heavily restored tooth abutment not suitable for an RBB

Primary outcomes:
measure: resin bonded bridge retention/survival
timeFrame: 12 month
Secondary outcomes:
measure: Patient's satisfaction
timeFrame: 12 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: October university for modern sciences and arts
Study officials:
References:
Clinical trial NCT06214091: Gastrointestinal Decompression in Stroke
Official title: Safety and Efficacy of Early Gastrointestinal Decompression for Patients With Acute Severe Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Stomach Acidity
Pulmonary Infection
Gastrointestinal Decompression
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute severe ischemic stroke is a life-threatening subtype of stroke. Due to stress ulcer and gastric reflux in acute stage, patients with severe ischemic stroke are always complicated with stomach bleeding and pulmonary infections, resulting in poor prognosis and even death. Reducing stomach acidity and avoiding gastric reflux play a pivotal role on controlling serious complications after austere ischemic attack. Gastrointestinal decompression is an cheap, safe, effective and acknowledgemented strategy for treating stomach bleeding and preventing gastric reflux in clinical settings. Early gastrointestinal decompression seems to be an available method to reduce stomach acidity and avoid gastric reflux after severe ischemic stroke. Therefore, we aimed to evaluate the safety and efficacy of early gastrointestinal decompression in patients with acute severe ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* severe AIS, including NIHSS score\>20 in dominant hemisphere infarction, or NIHSS score\>15 in non-dominant hemisphere infarction, or NIHSS consciousness score \>1; · massive infarction, characterized by infarction area larger than 1/3 of the effected middle cerebral artery territory and/or the cerebellum territory presented in admitted computed tomography (CT) or MRI
* onset-to-needle time within 24 hours
* prestroke modified Ranking scales (mRS)≤1
* sign the informed consent.

Exclusion Criteria:

* Recent respiratory infection and/or gastrointestinal bleeding
* austere diseases such as tumors and dyscrasia
* intention to undergo emergency thrombectomy
* pregnant women or nursing mother
* contraindication for gastric tubes
* participating in other clinical trials within previous 3 months.

Primary outcomes:
measure: 90-day Death
timeFrame: 90 days
Secondary outcomes:
measure: 90-day mRS
timeFrame: 90 days
measure: 90-day Barthel scores
timeFrame: 90 days
measure: 30-day mRS
timeFrame: 30 days
measure: 30-day Barthel scores
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03875391: The Effect of Oxytocin on the Consolidation of Trauma-Associated Memories
Official title: The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories: A Model to Understand the Development of Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrusive Memories
PTSD
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 217
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to examine whether oxytocin and certain polygenic risk scores affect the development of intrusive memories, a cardinal symptom of PTSD.


Eligibility criteria: Inclusion Criteria:

* healthy female volunteers
* German on a native level

Exclusion Criteria:

* former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
* any physical illnesses
* any medication intake (except oral contraceptive)
* history of traumatic experience, e.g. history of sexual abuse or rape
* pregnancy or lactation period
* follicular phase of menstrual cycle for all women not using oral contraceptives

Primary outcomes:
measure: Change of Intrusive Memories in the following four days after the intervention
timeFrame: four consecutive days
Secondary outcomes:
measure: Noradrenergic System (measured with salivary alpha-amylase - u/ml)
timeFrame: Day 1
measure: Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)
timeFrame: Day 1
measure: Polygenic Risk Score
timeFrame: four consecutive days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité- Universitätsmedizin Berlin
Study officials:
affiliation: Charité
name: Stefan Roepke, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04906291: The Preventive Effect of 2-years Use of Hydroxyapatite Containing Toothpastes in Children.
Official title: The Caries Preventive Effect of 2-years Use of Hydroxyapatite Containing Toothpastes in Children. A Triple-blind Randomized Placebo-controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries
Keywords: Toothpaste, hydroxyapatite, Fluoride, Dental Caries, RCT, Children
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 610
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this RCT was to verify the caries preventive efficacy of toothpastes containing biomimetic hydroxyapatite (H.A.) complex in children compared to traditional fluoridated toothpastes. In total 610 children of two age groups (4-5 years and 6-7 years at baseline) were enrolled. Four toothpastes, two containing fluoride-substituted hydroxyapatite (H.A.F.) (1000 and 1450 ppm F-) and magnesium-, strontium-, carbonate-substituted hydroxyapatite, in a chitosan matrix and two traditional fluoridated toothpastes (1000 and 1450 ppm F-) without other active components were administered randomly to two groups with younger children (Gyoung) and to two groups with older children those containing1450 ppm F (GOLD) during 24 months. A standardized questionnaire was administered to parents/caregivers to gain information regarding caries risk factors. Caries evaluation was performed at school using ICDAS, scoring lesions as initial (up to score 2), moderate (scores 3-4) and severe (scores 5-6).


Eligibility criteria: Inclusion Criteria:

* Written declaration of informed consent signed by parents/guardians;
* Age between 4-5 years and 6-7 years; Good general health, as assessed by the examiners;
* Agreement of not to use any oral hygiene products except for the toothpastes provided for the duration of the study.

Exclusion Criteria:

* Ongoing oral or dental treatment except for emergency treatment;
* Known allergic reaction to an oral hygiene product and/or medication and/or dental material previously used in the mouth or pharynx;
* Allergy to one of the components of the test products or the standard toothpaste;
* Participation in another clinical trial either currently or within the last 30 days;
* Antibiotic therapy within the past 3 months.

Primary outcomes:
measure: Caries Progression rate
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sassari
country: Italy
facility: University of Sassari, Dept of Surgery, Microsurtgery and Medicine Sciences
state: SS
Study officials:
References:
Clinical trial NCT01323491: "EASY EFFECTIVE SMOKELESS" With NICORETTE®
Official title: Nicht-interventionelle Studie (NIS) Zur Strukturierten Raucherentwöhnung Nach Dem Konzept "EINFACH ERFOLGREICH RAUCHFREI" unterstützt Durch NICROETTE®-Produkte
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stereotyped Behavior
Tobacco Smoking Behavior
Keywords: smoking cessation
nicotine replacement therapy
routine smokers
Lead sponsor: Johnson & Johnson GmbH
Sponsor class: INDUSTRY
Collaborators: name: Anfomed GmbH
First posted: 2011-03-25
Enrollment: 184
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: general practitioners

Brief summary: The actually most accepted method of effective smoking cessation is based on structured consultation and medical care in combination with supportive medical treatment. A group of experts developed the concept "EINFACH ERFOLGREICH RAUCHFREI" ("EASY EFFECTIVE SMOKELESS") for general practitioners providing a structured compendium for negotiation.

Physicians who have implemented this concept will conduct this non-interventional study. The implementation of the scheme will be investigated under general practice conditions and the applicability of the concept has to be assessed by the physicians.

In addition further knowledge of smoking cessation in would-be non-smokers which decided to quit, supported by medical treatment with NICORETTE®-products, will be documented for a large patient collective under real practice conditions.

To answer all above mentioned questions for a sufficient number of patients a multicenter, prospective non-interventional study design was used for this trial as only this instrument detects characteristics of the physicians' treatment without any further input or other influences.


Eligibility criteria: Inclusion Criteria:

* Routine smokers
* Nicotine replacement therapy with Nicorette® according to physicians treatment decision

Exclusion Criteria:

* Pregnancy
* Contraindication according to Summary of Product Characteristics (SPC)
* Other nicotine replacement therapy during the last month

Primary outcomes:
measure: Further knowledge of smoking cessation in would-be non-smokers
timeFrame: Baseline (about 2 weeks before date of smoking cessation), Follow-up (about 3, 14 and 28 days after date of smoking cessation), Final examination (about 3 months after date of smoking cessation)
Secondary outcomes:
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Johnson & Johnson GmbH
Study officials:
References: