louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00708812: Paclitaxel Plus Carboplatin With or Without Endostar in Patients With Advanced Non-small Cell Lung Cancer
Official title: Paclitaxel Plus Carboplatin (TC) Versus TC Plus Endostar in Patients With Advanced Non-small Cell Lung Cancer(NSCLC): a Randomized, Double-blind, Placebo-controlled, Multicentre Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Non-small Cell Lung Cancer
Keywords: Non-small Cell Lung Cancer
Endostar
Paclitaxel
Carboplatin
Lead sponsor: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 126
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: In this randomized, double-blind, placebo-controlled, multicentre trial, 126 patients between July 5, 2007 and July 30, 2008 were enrolled from 10 centers. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University and Shanghai Changzheng Hospital. All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy, patients evaluated as SD (Stable Disease) or above were randomized to receive endostar plus TC or TC alone for 3 cycles, 21 days as one cycle.


Eligibility criteria: Inclusion Criteria:

* histologically or cytologically confirmed, previously untreated stage IIIB or IV NSCLC
* age of 18-75 years
* at least one measurable lesion (RECIST)
* patients evaluated as SD or above after 1 cycle (21 days) of TC chemotherapy .
* adequate hematologic, cardiac, renal, and hepatic function
* ECOG PS 0-2

Exclusion Criteria:

* symptomatic brain metastases
* bone metastases with complications
* major organ dysfunction
* bleeding diathesis or coagulopathy
* pregnant or lactating woman

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: every 2 months until disease progression
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: the end of each cycle
measure: Overall Survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT03566212: Efficacy of Camouflaged Syringe vs Conventional Syringe
Official title: Clinical Comparative Study of Efficacy of Camouflaged Syringe vs Conventional Syringe in Reducing Dental Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Behavior
Keywords: Anxiety
Camouflaged syringe
Conventional syringe
Lead sponsor: Saraswati-Dhanwantari Dental College & Hospital
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: local anesthesia is administered by using either camouflaged syringe or conventional syringe and was compared for reduction in anxiety levels in both groups
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of Camouflage syringe vs Conventional syringe in reducing Dental Anxiety and increasing behaviour rating.Half of the participants received local anesthesia using camouflaged syringe, while others received using conventional syringe.

Detailed description: Dental anxiety and phobia result in avoidance of dental care. Since the injection itself can be painful, pain reduction procedures warrant continued investigation. Camouflage design deals with the visual impact of the needle and syringe though the tactile sensation remains unaltered. In our study, post treatment anxiety levels in camouflaged syringe was reduced as compared to conventional syringe group and this might be because, patients with low anxiety tend to have high pain thresholds.

Eligibility criteria: Inclusion Criteria:

* retained teeth,
* badly carious teeth,
* mobile teeth
* requiring a dental procedure under local anesthesia were selected.

Exclusion Criteria:

* Mentally challenged children
* those with medical conditions contraindicating the use of local anesthesia and / or surgical procedures

Primary outcomes:
measure: Anxiety levels by using the Chotta Bheem and Chutki scale
timeFrame: after 5 minutes
Secondary outcomes:
measure: Behavior rating by using Frankel Behaviour rating scale
timeFrame: after 10 minutes
Other outcomes:
Locations:
city: Parbhani
country: India
facility: Dr Sneha D Suwarnkar
state: Maharashtra
Study officials:
affiliation: Saraswati Dhanwantari Dental College and Hospital, Parbhani
name: Sneha D Suwarnkar, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02107612: Randomized Study For Minimally Invasive Splinted Implants
Official title: Development of Minimally Invasive Splinted Dental Implants to Stabilize Mandibular Overdentures, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous
Keywords: Mini-Dental Implant
Implant-Supported Dental Prosthesis
Minimally Invasive Surgical procedures
Overdentures
Aged
Lead sponsor: University of Concepcion, Chile
Sponsor class: OTHER
Collaborators: name: Public Health Service of Chile
First posted: 2014-04-08
Enrollment: 43
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the effect of a integrated system for inserting two splinted minimally-invasive implants, to retain mandibular over dentures, on the quality of life of edentulous patients.


Eligibility criteria: Inclusion Criteria:

* Edentulous
* Men and women
* Between 45 and 90 years of age
* Who had a persistent loss of stability and retention of their conventional mandibular dentures
* Without temporomandibular disorders

Exclusion Criteria:

* Uncontrolled systemic disease (eg, hypertension, diabetes)
* Severe osteoporosis (bone mineral density \> 2.5 SD below the young adult reference mean, plus 1 or more fragility fractures) and/or taking bisphosphonates
* Mental disorders
* Who had received radiotherapy in the 18 months prior to the trial

Primary outcomes:
measure: Change in Quality of Life
timeFrame: One year
Secondary outcomes:
measure: Incidence of complications
timeFrame: Two years
Other outcomes:
measure: Average marginal bone loss in the peri-implant zone
timeFrame: Two years
measure: Average of maximal bite force
timeFrame: Fifteen months
measure: Mini-implant survival rate
timeFrame: Two years
Locations:
city: Concepción
country: Chile
facility: University of Concepción
state: Región del Bio Bio
Study officials:
affiliation: University of Concepcion
name: Jorge Jofre, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jofre J, Castiglioni X, Lobos CA. Influence of minimally invasive implant-retained overdenture on patients' quality of life: a randomized clinical trial. Clin Oral Implants Res. 2013 Oct;24(10):1173-7. doi: 10.1111/j.1600-0501.2012.02529.x. Epub 2012 Jul 4.
citation: Jofre J, Cendoya P, Munoz P. Effect of splinting mini-implants on marginal bone loss: a biomechanical model and clinical randomized study with mandibular overdentures. Int J Oral Maxillofac Implants. 2010 Nov-Dec;25(6):1137-44.
citation: Jofre J, Conrady Y, Carrasco C. Survival of splinted mini-implants after contamination with stainless steel. Int J Oral Maxillofac Implants. 2010 Mar-Apr;25(2):351-6.
citation: Jofre J, Hamada T, Nishimura M, Klattenhoff C. The effect of maximum bite force on marginal bone loss of mini-implants supporting a mandibular overdenture: a randomized controlled trial. Clin Oral Implants Res. 2010 Feb;21(2):243-9. doi: 10.1111/j.1600-0501.2009.01834.x.
Clinical trial NCT05449912: Impact of Environmental Exposure at Home Address on One-year Post-myocardial Infarction Survival
Official title: ENVI-MI (Environment and Myocardial Infarction) : Impact of Environmental Exposure at Home Address on One-year Post-myocardial Infarction Survival
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 982
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients registered in the RICO database

Brief summary: Numerous studies have explored the effects of environmental exposure to noise, air pollution and proximity to "natural" areas on various conditions. However, very few studies have focused on the "post-diagnosis" follow-up of patients after hospitalization for an ischemic cardiovascular episode and, to our knowledge, none have examined patient evolution at one year after myocardial infarction. Thus, the real influence of factors and pollutants widely represented in the urban environment, in particular air pollution, noise pollution, and proximity and accessibility to natural areas ("green" or "blue" spaces), on the evolution of post-myocardial infarction at one year remains to be identified and quantified.

The objective of the ENVI-MI project is to evaluate the impact of environmental exposure in the place of residence (noise, air pollution, proximity to "natural" spaces) on the evolution of post-myocardial infarction at one year within the Dijon metropolitan area.


Eligibility criteria: Inclusion Criteria:

Patient :

* registered in the RICO database
* hospitalized for MI between January 1, 2002 and December 31, 2008,
* whom residence is located in one of the 15 communes of the Dijon urban unit (except for patients living in the area subject to the noise exposure plan of the military airport)

Exclusion Criteria: NA

Primary outcomes:
measure: Occurrence of a cardiovascular event
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT00482612: Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)
Official title: A Two-Week, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Efficacy and Safety Out-Patient Trial With Org 50081 in Patients With Chronic Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-06-05
Enrollment: 526
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 purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.


Eligibility criteria: Inclusion Criteria:

* Has signed written informed consent after the scope and nature of the investigation was explained to them
* Has difficulty falling asleep, maintaining sleep or has early morning awakenings

Exclusion Criteria:

* Significant medical or psychiatric illness causing sleep disturbances
* Has a history of bipolar disorder or family (immediate family) of suicide
* Has sleep disorder such as sleep related breathing disorder, restless leg syndrome, narcolepsy
* Has significant other medical illness such as acute or chronic pain, heart, kidney or liver disease within the last year
* Currently diagnosed or meets the criteria for Major Depressive Disorder (MDD) or has been treated for MDD with the last 2 years
* Substance abuse, excessive use of alcohol (as determined by the physician) or drug addiction within the last year.

Primary outcomes:
measure: Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period
timeFrame: Day 1 to Day 15
Secondary outcomes:
measure: Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period
timeFrame: Day 1 to Day 15
measure: Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period
timeFrame: Day 1 to Day 15
measure: Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period
timeFrame: Day 1 to Day 15
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Ivgy-May N, Roth T, Ruwe F, Walsh J. Esmirtazapine in non-elderly adult patients with primary insomnia: efficacy and safety from a 2-week randomized outpatient trial. Sleep Med. 2015 Jul;16(7):831-7. doi: 10.1016/j.sleep.2015.03.005. Epub 2015 Mar 30.
Clinical trial NCT01742312: Effects of Chemotherapy on Muscle Mass and Exercise Performance in Patients With Oesophageal Cancer.
Official title: Effect of Neoadjuvant Chemotherapy on Muscle Mass and Peri-operative Cardiorespiratory Performance in Patients Undergoing Oesophageal Cancer- a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oesophageal Adenocarcinoma
Keywords: neoadjuvant chemotherapy
oesophageal cancer
cardiorespiratory performance
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: University Hospitals of Derby and Burton NHS Foundation Trust
First posted: 2012-12-05
Enrollment: 25
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: healthy volunteers oesophageal cancer patients

Brief summary: Curative treatment for oesophageal cancer involves undertaking chemotherapy followed by an operation to remove the tumour. Chemotherapy has several effects upon the body, including effects upon the systems that control the creation and breakdown of muscle. We aim to review these effects by recording changes in the amount of exercise patients are able to undertake after chemotherapy and reviewing changes in muscle mass.

Detailed description: We aim to review the effects of chemotherapy on skeletal muscle mass and cardio-respiratory performance in patients with oesophageal adenocarcinoma. All patients will be assessed by a Consultant Anaesthetist and a medical member of the Research team before commencing chemotherapy and after finishing their course. These assessments include a nutritional assessment, performance status assessments, blood assays, dual energy X-ray absorptiometry (DEXA) scans, cardio-pulmonary exercise (CPEX) testing and a muscle biopsy.

Eligibility criteria: Inclusion Criteria:

* oesophageal cancer
* Multidisciplinary team decision to offer neoadjuvant chemotherapy prior to surgery

Exclusion Criteria:

* Metastatic disease

Primary outcomes:
measure: muscle mass
timeFrame: 3 months
Secondary outcomes:
measure: nutritional status
timeFrame: 3 months
measure: all cause mortality
timeFrame: 3 months
measure: mitochondrial function performance status
timeFrame: 3 months
measure: cardiorespiratory performance (peak VO2)
timeFrame: 3 months
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Graduate Entry Medical School, University of Nottingham
state: Derbyshire
Study officials:
affiliation: Graduate Entry Medical School, University of Nottingham
name: John Williams, MBChB, FFPMRCA, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06279312: The Effect of Adaptogen Elixir on Sleep Improvement
Official title: The Effect of Adaptogen Elixir on Sleep Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Anxiety Disorders
Keywords: Adaptogen
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 52
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: This study aims to examine the effectiveness of Adaptogen Elixir herbal drink in relieving emotions and improving sleep quality. Participants will be randomly assigned to either the placebo group or the Adaptogen Elixir herbal drink group, with 25 participants in each group. On the day of the experiment (week 0), participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions. Subsequently, participants will be given the experimental samples and instructed to consume them continuously for 4 weeks following the instruction. Follow-up assessments will be conducted in the 2nd and 4th weeks, participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions.


Eligibility criteria: Inclusion Criteria:

* Adults aged above 18 years old.
* Individuals experiencing insomnia issues (PSQI \> 5) or high levels of anxiety (GAD-7 \> 9).
* No medication use or regular use of sleeping pills or antidepressants in the past month.
* No ongoing mental illnesses.
* No ongoing physical illnesses.
* No other sleep disorders.
* No circadian rhythm issues.
* No consumption of sleep or stress-related supplements in the past month.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Individuals with significant organic diseases such as organ transplants, epilepsy or seizures, liver or kidney diseases, malignant tumors, endocrine disorders, or a history of alcohol or substance use disorders.
* Individuals known to be allergic to any components of the product.

Primary outcomes:
measure: Sleep monitoring
timeFrame: Week 0 (Baseline), Week 2, Week 4
measure: Sleeping qualityy
timeFrame: Week 0 (Baseline), Week 2, Week 4
measure: Sleeping disorders
timeFrame: Week 0 (Baseline), Week 2, Week 4
Secondary outcomes:
measure: Neuropeptide Y concentration
timeFrame: Week 0 (Baseline), Week 2, Week 4
measure: Cortisol concentration
timeFrame: Week 0 (Baseline), Week 2, Week 4
measure: Anxiety
timeFrame: Week 0 (Baseline), Week 2, Week 4
measure: Low Frequency/High Frequence (LF/HF) ratio
timeFrame: Week 0 (Baseline), Week 2, Week 4
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Hsin-Chien Lee, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04237012: ACCURATE Study for Subjects With Dry Eyes
Official title: Randomized Self-Controlled Treatment With an Intracanalicular Dexamethasone Insert Compared to Topical Over the Counter Lubrication Therapy in Patients With Bilateral Ocular Surface Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: The Eye Centers of Racine and Kenosha
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine treatment and imaging outcomes in bilateral ocular surface disease management with an intracanalicular dexamethasone (0.4 mg) insert compared to standard topical over-the-counter artificial tears lubrication management

Detailed description: This study will evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert and patient administered artificial tears prn compared to patient administered artificial tears prn (control) in patients with bilateral ocular surface dry eye disease. The study is a self-controlled design and includes multiple objective, measureable, and quantifiable endpoints to best determine an objective response to treatment in patient eyes randomized to either the insert plus prn artificial tears or artificial tears prn control. To aid in ensuring best possible masking, DEXTENZA is best visualized with blue light and yellow filter and therefore visualization will not be assessed until final visit following all measures.

Eligibility criteria: Inclusion Criteria:A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

* Age 18 years and older
* Demonstrate objective signs of Ocular Surface Disease (OSD) or
* Demonstrate symptoms of OSD determined by a standardized questionnaire
* No other corneal pathology to create unknown variability

Exclusion Criteria:A patient who meets any of the following criteria in either eye will be excluded from the study:

* History of using topical steroids or other anti-inflammatory drops within 6 months of the study
* History of corticosteroid implant (Ozurdex or Iluvien) or intravitreal steroid use for macular disease in last 12 months
* History or current use of oral steroids or immunosuppressants
* Active ocular infection
* History of HSV
* History corneal refractive surgery
* Uncontrolled Glaucoma

Primary outcomes:
measure: Determine effect of dexamethasone insert over artificial tears
timeFrame: 1 month
Secondary outcomes:
measure: OSDI scores
timeFrame: 1 month
Other outcomes:
measure: ITRACE
timeFrame: 1 month
measure: IOL Master
timeFrame: 1 month
Locations:
city: Racine
country: United States
facility: The Eye Center of Racine
state: Wisconsin
Study officials:
affiliation: President
name: Inder P Singh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: