louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00384540: Cardiac Allograft Vasculopathy and Dobutamine Stress Echocardiography / Brain Natriuretic Peptide Coupling
Official title: Allograft Vasculopathy After Heart Transplantation : Diagnostic Interest of Dobutamine Stress Echocardiography and Brain Natriuretic Peptide Coupling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vasculopathy
Allograft
Keywords: -Heart Transplant, Allograft Vasculopathy, Dobutamine Stress Echocardiography, Brain Natriuretic Peptide
Vasculopathy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2006-10-06
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Primary purpose :To early detect cardiac allograft vasculopathy and to identify patients with high risk of cardiac events, by coupling the analysis of the kinetics of the brain natriuretic peptide ( BNP) with that of the left ventricle (LV) during a dobutamine stress echocardiography.

Hypothesis : Plasma BNP elevation and abnormalities of LV kinetic during the ESD, will be associated with the presence of allograft vasculopathy and the arisen of cardiovascular events.


Eligibility criteria: Inclusion criteria:

* Heart transplant recipients

Exclusion criteria:

* No respect of inclusion criteria
* Pregnancy
* Severe renal failure (creatinin clearance \< or equal to 30 ml/min)
* Dobutamine stress echocardiography contraindication

Primary outcomes:
measure: Cardiovascular events vs Dobutamine stress echocardiography each 2 years
timeFrame: 5 years
Secondary outcomes:
measure: Flow mediated humeral dilatation each 2 years
timeFrame: 5 years
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Physiologie et d'Explorations Fonctionnelles, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Samy TALHA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01987440: Effect of Lubricating Gel for Pain Relief During Speculum Examination in Gynecologic Oncology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Erzincan Military Hospital
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Pelvic examination, an important part of gynecologic oncology patients to help detect cancers recurrence or infections.Despite its importance, many women are reluctant and anxious about the procedure because of fear, as well as discomfort and pain. The objective of this study is to estimate whether using lubricating gel decreases patient pain during speculum insertion compared with using water in gynecologic oncology patients


Eligibility criteria: Inclusion Criteria:

\*Female patients WHO came for surveillance for malignant gynecologic disease such as uterine cancer, cervix cancer, and ovarian cancer with or without radiotherapy and chemotherapy

Exclusion Criteria

* Women were undergoing Vulvectomy or Vaginectomy
* Women with narrow vagina for standard medium size of speculum for examination
* Women who underwent fertility sparing surgery.
* Women had vaginitis

Primary outcomes:
measure: Visual Analog Scale
timeFrame: During Speculum Examination Dilatation stage
Secondary outcomes:
measure: visual analog scale insertion stage
timeFrame: uring Speculum Examination insertion stage
Other outcomes:
measure: VAS score extraction
timeFrame: Durig extraction the speculum
Locations:
city: İzmir
country: Turkey
facility: Tepecik Education and REserch Hospital
state: Tepecik
Study officials:
References:
Clinical trial NCT02792140: The Impact of the Opiate Antagonist Naltrexone on the Emotional Valence of Dreams
Official title: The Impact of the Opiate Antagonist Naltrexone on the Emotional Valence of Dreams
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuroscience of Dreaming, Healthy
Keywords: Psychology
Dreams
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
First posted: 2016-06-07
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, the investigators pose the question which influence the opioid circuit has on positive valent situations in dreams.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Healthiness
* Good capacity of remembering dreams
* No opiate consumption

Exclusion Criteria:

* Simultaneous participation in other studies
* Addictive disorder
* Abnormal liver function
* Abnormal kidney function
* Hypersensitivity to active ingredient or pharmaceutical additives
* Hereditary galactose intolerance
* Lactase deficiency
* Glucose-galactose malabsorption
* Intake of opioid medication

Primary outcomes:
measure: VAS-difference concerning the emotional valence of dreams
timeFrame: 7 days per condition (Naltrexone, Placebo), intermitted by 14 days of washout
Secondary outcomes:
measure: Semiquantitative score of emotional valence of dreams
timeFrame: 7 days per condition (Baseline, Naltrexone, Placebo), intermitted by 14 days of washout
measure: Qualitative score of emotional valence of dreams
timeFrame: 7 days per condition (Baseline, Naltrexone, Placebo), intermitted by 14 days of washout
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: Head of Cognitive Psychology, Perception and Research Methods, Dean Human Sciences Faculty, Ordinarius, University of Bern
name: Fred Mast, Prof. Dr. phil.
role: STUDY_DIRECTOR
affiliation: Chairman and Head, Department of Neurology Inselspital, Bern University Hospital
name: Claudio L. Bassetti, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03342040: Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair
Official title: Randomized Clinical Trial: Transverse Abdominis Plane Block Versus no Block in Laparoscopic Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Keywords: TAP block
laparoscopic IPOM
post operative pain
Lead sponsor: GEM Hospital & Research Center
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 90
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective double blinded balanced allocation, randomized clinical trial
Primary purpose: TREATMENT

Brief summary: The current study aims to determine if transverse abdominis plane block using local anesthetic agents (bupivacaine 0.25% + Ropivacaine 0.20%) decreases the post operative pain and helps in early mobilization or discharge from hospital in patients undergoing laparoscopic ventral hernia repair.

Detailed description: Patients meeting inclusion criteria would be randomised after admission. Those patients in experimental arm shall receive the TAP block under USG guidance while those in control arm do not receive any block. Surgery shall be proceeded in the usual manner in all the patients and assessment for pain starts in the immediate post operative or recovery room after the patient is completely conscious. The total amount of analgesic required by the patient is measured. Pain assessment is done using the visual analog scale (VAS) at regular intervals until follow up review.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing laparoscopic ventral hernia repair during the study period

Exclusion Criteria:

* Age \<15 or greater than 75 years
* ASA \> 3
* Obstructed , recurrent or strangulated hernia
* Lap assisted open hernia repair
* Patients undergoing component separation
* Parastomal hernia, spigelian hernia, lumbar hernia
* Patients with Chronic kidney disease, bronchial asthma
* Patients allergic to bupivacaine or NSAIDs
* Not willing to participate

Primary outcomes:
measure: Post operative cumulative analgesic requirement
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Post-operative hospital stay
timeFrame: 7 days from primary surgery
Other outcomes:
Locations:
city: Coimbatore
country: India
facility: Gem hospital and research centre
state: Tamil Nadu
Study officials:
affiliation: Gem Hospital and research center
name: C C Palanivelu, MS, MCh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02191540: Efficacy and Safety Study of Abnoba Viscum F 20mg in Malignant Pleural Effusion Patients
Official title: A Phase 3, Multi-Center, Single-Arm, Open-Label Study For The Safety And Efficacy Of Mistletoe Extract (AbnobaViscum® Injection) In Malignant Pleural Effusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malignant Pleural Effusion
Lead sponsor: Abnoba Korea
Sponsor class: INDUSTRY
Collaborators: name: Abnoba Gmbh
First posted: 2014-07-16
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 3, non-randomized, Multicenter, single arm study to assess efficacy and safety of Abnoba viscum F 20mg in patients with malignant pleural effusion


Eligibility criteria: Inclusion Criteria:

* Subject who need the pleurodesis among subjects diagnosed with a mlignant pleural effusion
* Full lung expansion must be achieved within 12 to 24 hours after drainage
* Expected survival time of at least 2 months
* Subject who score 50 or more on the Karnofsky Performance Scale

Exclusion Criteria:

* Subjects with previous attempts at pleurodesis with sclerosing agent
* Subjects with trapped lung or bronchial obstruction
* Subjects with adverse drug response to mistletoe agents
* Subjects who have participated in another clinical study other than the present study
* Subjects who is taking immune-suppressive agents
* Subjects with medical and psychiatric contraindications for the study drug
* Subjects who are not allowed to participate in the study by legal requirement
* Subjects who are not allowed to participate in the study by the Investigator's discretion

Primary outcomes:
measure: Efficacy
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hwasun gun
country: Korea, Republic of
facility: Chonnam National University Hwasun hospital
state: Jeolla Namdo
city: Busan
country: Korea, Republic of
facility: Busan University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Kook Joo Na, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: FORSCHUNGSINSTITUT HAVELHOHE
name: Friedemann Schad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ulsan University Hospital
name: YongJik Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Busan University Hospital
name: Yeong Dae Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01867840: Role of ASICs in Human Inflammatory Pain
Official title: Study of the Role of Acid Sensing Ion Channels (ASICs) in Human Inflammatory Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthritis
Osteoarthritis
Chondrocalcinosis
Gouty Arthritis
Rheumatoid Arthritis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: (osteoarthritis, chondrocalcinosis, gouty arthritis, rheumatoid arthritis)

Brief summary: In recent years, ion channels have emerged as new therapeutic targets for pain. Among these channels, ASICs (Acid Sensing Ion Channels) are of particular interest because they are directly activated by extracellular acidity, which is a major cause of pain. Indeed, many painful conditions such as ischemia, inflammation, tumor development or tissue incision are accompanied by tissue acidification. ASIC are excitatory ion channels that are expressed in neurons, including nociceptive sensory neurons. In humans, the use of amiloride, a nonspecific inhibitor of ASICs, has demonstrated their role in the perception of pain induced by subcutaneous injections of acidic solutions. ASICs thus appear as new candidates capable of mediating pain in humans. A growing number of data suggests that, in addition to protons, ASICs may also be activated by one or more endogenous compounds produced during inflammation. The purpose of this research project is to identify these compounds by testing the effects of human inflammatory exudates on ASICs activity. The discovery of such compounds would definitely validate ASICs as novel therapeutic targets for pain treatment in humans


Eligibility criteria: Inclusion Criteria:

* septic arthritis
* gonarthrosis in push-inflammatory
* microcrystalline arthropathies
* chronic inflammatory rheumatism

Exclusion Criteria:

* refusal to participate in the protocol

Primary outcomes:
measure: activation or miodulation to Electrical potential of ionic channel in the synovial fluid
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Service de Rhumatologie
Study officials:
affiliation: service de rhumatologie
name: Véronique BREUIL, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02374840: Pharmacogenomics Registry to Assess Clinical Utility
Official title: Pharmacogenomics Registry to Assess Clinical Utility
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Drug Side Effects
Keywords: Pharmacogenomics
Adverse Drug Reactions
Pharmacogenetics
Lead sponsor: Companion Dx Reference Lab, LLC
Sponsor class: INDUSTRY
First posted: 2015-03-02
Enrollment: 340778
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects aged 2 years and above, currently receiving or under consideration to receive at least one medication known to be metabolized through relevant genetically-modified pathways.

Brief summary: The PREACT Registry aims to see whether data from Pharmacogenomic Testing (PGx) can help healthcare providers manage patient medication regimens and assess if the testing has an effect on reducing medication side effects, hospitalizations and emergency department visits.

The way an individual processes a drug is in part determined by their genes, and there is known to be genetic variation between humans in the way drugs are metabolized. The study of the way genes affect a person's response to drugs is known as "Pharmacogenomics."


Eligibility criteria: Inclusion Criteria:

* Pharmacogenomic testing has been performed within 12-months prior to eligibility assessment for genes known to influence metabolism of at least one target drug
* Subject is 2 years of age or older
* Subject is not taking an investigational medication or in a clinical trial that would interfere with participation in the registry

Exclusion Criteria:

* Subject's medical and medication history is unavailable over the 90-day period preceding the receipt of pharmacogenomic test results
* Subject (or subject's parent/guardian) is unable to provide an accurate history due to mental incapacity, in the Investigator's opinion.

Primary outcomes:
measure: Meaningful Change
timeFrame: 90 day
Secondary outcomes:
measure: Changes in target drug regimen
timeFrame: 90 days retrospective; 90 days prospective
measure: Number of target drug adverse events (TDAE)
timeFrame: 90 day retrospective; 90 day prospective
measure: Target drug related emergency department visits
timeFrame: 90 day retrospective; 90 day prospective
measure: Target drug related hospitalizations
timeFrame: 90 day retrospective; 90 day prospective
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00716040: Social-Psychological Intervention to Improve Adherence to HAART
Official title: Effectiveness of a Social-Psychological Intervention to Improve Adherence to Antiretroviral Drug Regimens for AIDS: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: AIDS
HIV Infections
Keywords: AIDS treatment
HAART adherence
intervention
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2008-07-16
Enrollment: 121
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: All eligible patients will be invited to use electronic monitoring of medication (MEMS) during the next six months. After two months with MEMS the enrolled patients will be randomized to intervention group or to control group. The intervention group will be submitted to four social-psycho sessions with a pre-trained health professional. The control group will receive the usual care of the health service.

The study will compare the rate of adherence to antiretroviral therapy between the intervention group and the control group. The duration of the study will be of six months. The analysis will be based on "intention-to-treat.


Eligibility criteria: Inclusion Criteria:

* Patients aged more than 18 years old, with detectable viral load and more than six months under HAART

Exclusion Criteria:

* Pregnant women
* Patients participating in other trials
* Patients in treatment for hepatitis and for active opportunistic infection
* Patients with mental or physical condition which do not allow their attendance to the health service

Primary outcomes:
measure: Adherence to HAART
timeFrame: 24 weeks
Secondary outcomes:
measure: Viral Load
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Centro de Referência e Treinamento DST/AIDS
Study officials:
affiliation: Faculty of Medicine -University of Sao Paulo
name: Maria Ines B Nemes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional University of Blumenau
name: Ernani T Santa Helena, PhD
role: STUDY_DIRECTOR
References:
citation: Basso CR, Helena ET, Caraciolo JM, Paiva V, Nemes MI. Exploring ART intake scenes in a human rights-based intervention to improve adherence: a randomized controlled trial. AIDS Behav. 2013 Jan;17(1):181-92. doi: 10.1007/s10461-012-0175-4.
Clinical trial NCT00521040: Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR
Official title: Evaluation of the Efficacy and Safety of Levocetirizine During 8 Weeks Preceding and Following the Anticipated Onset of the Grass Pollen Season in Subjects Suffering From Seasonal Allergic Rhinitis Associated With Pollen-induced Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinitis, Allergic, Seasonal
Keywords: Levocetirizine dihydrochloride
Xyzal tablets
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-08-27
Enrollment: 459
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR


Eligibility criteria: Inclusion Criteria:

* male or female subjects ≥ 12 years
* 2 year history of seasonal allergic rhinitis
* documented hypersensitivity to local seasonal allergens (grass pollen)
* documented pollen-induced asthma
* without acute ongoing exacerbation of asthma or allergic rhinitis
* no continuous ongoing treatment for rhinitis or asthma

Exclusion Criteria:

* non-allergic rhinitis and anatomic abnormalities disturbing the analysis of nasal capacity
* symptomatic rhinitis or asthma due to tree pollens
* currently treated by specific grass pollen immunotherapy
* suffering from non-allergic asthma
* chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroid dependent asthma
* atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
* contraindication for salbutamol use

Primary outcomes:
measure: T4SS (sum of the scores of the severity of sneezing, rhinorrhea, nasal pruritus and ocular pruritus)
timeFrame: 12 weeks
Secondary outcomes:
measure: Pollen-induced symptomatology of asthma; symptoms of rhinitis and asthma over the first 4 season weeks and during the entire observation period following the actual onset of the grass pollen season
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT07026240: Post-operative Monitoring of Gastric Cancer
Official title: Post-operative Monitoring of Gastric Cancer Using Circulating DNA in Blood Samples
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Lead sponsor: Suzhou Huhu Health & Technology Inc.
Sponsor class: INDUSTRY
Collaborators: name: Fudan University
First posted: 2025-06-18
Enrollment: 258
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: Subjects age over 18, regardless of gender or region, and those who meet the inclusion criteria for this clinical trial, are eligible to enroll at the designated clinical sites. More than 258 subjects are targeted to enroll.

Brief summary: This study is to determine the performance of non-invasive new multi-target biomarkers in the post-operative monitoring of gastric cancer.

Detailed description: This study aims to develop and validate a new non-invasive detection method for postoperative monitoring of gastric cancer in the blood. Blood will also be collected at various time points post-operatively. We will determine whether these new biomarkers can be used as prognostic biomarkers to predict tumor recurrence and metastasis. We will also determine whether these new biomarkers detect tumor recurrence and metastasis earlier than methods currently used in the clinic such as imaging and tumor biomarkers CA19-9, CEA, and CA72-4.

This study is a prospective and multi-center study.

Eligibility criteria: Inclusion Criteria:

1. Subject age over 18.
2. Subject has stomach discomfort, and seek medical attention at the Gastric Surgery Department of our center.
3. Subject has or will have gastroscopy and/or pathological examination results at this center.
4. Subject must be able to fully understand the informed consent form and be able to personally sign it.

Exclusion Criteria:

1. Subject has serious heart, liver, kidney dysfunction, or mental illness.
2. Subject diagnosed previously with any kind of malignant tumor.
3. Subject is known to be infected with HIV or other related diseases (considering interference from the use of immune drugs).
4. Subject is receiving targeted drugs, immunosuppressants, immunomodulators, and biological therapies.
5. Researchers believe that subject is not suitable for enrollment.
6. Subject can not supply sufficient sample to complete this experiment.

Primary outcomes:
measure: The performance of the new biomarkers in the post-operative monitoring of gastric cancer
timeFrame: 2 years
Secondary outcomes:
measure: Metastasis Detection Time: New vs. Conventional Methods
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Dazhi Xu, MD., PhD,
role: PRINCIPAL_INVESTIGATOR
References: