louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06776484: Biological Evolution of Whipple's Disease (WHIP)
Official title: Biological Evolution of Whipple's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Whipple Disease
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective study of patients hospitalised in Brest who tested positive for Whipple's disease between 2010 and 2024

Brief summary: Whipple's disease (WD), a rare systemic infection by Tropheryma whipplei, lacks research on biological abnormalities pre- and post-treatment. This study explores these abnormalities for their diagnostic and monitoring value.

Detailed description: Whipple's disease (WD) is a rare systemic infection caused by \*Tropheryma whipplei\*. Despite advancements in diagnosis through PCR and biopsy, there is limited research comparing biological abnormalities before and after treatment. This study aimed to characterize these abnormalities and evaluate their potential for aiding in diagnosis and monitoring.

Eligibility criteria: Inclusion Criteria:

* Patients with at least one positive PCR test for Whipple's disease and a retained diagnosis at Brest University Hospital between 2010 and 2024
* Major patient

Exclusion Criteria:

* Minors
* No screening test for Whipple's disease
* Opposition to participation
* Protected patients

Primary outcomes:
measure: Biological changes
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT05623384: Effect of Ultrasound-guided Stellate Ganglion Block Combined With Facial Nerve and Glossopharyngeal Nerve Block on the Treatment of Sudden Deafness
Official title: Effect of Ultrasound-guided Stellate Ganglion Block Combined With Facial Nerve and Glossopharyngeal Nerve Block on the Treatment of Sudden Deafness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sudden Deafness
Keywords: Sudden deafness
Stellate Ganglion Block
Facial nerve block
Glossopharyngeal nerve block
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 90
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: PREVENTION

Brief summary: Sudden deafness is a sudden, unexplained sensorineural hearing loss of ≥20 dBHL in at least two adjacent frequencies within 72 h. It may be accompanied by tinnitus, a sense of ear congestion, vertigo and other Symptoms.Stellate ganglion block increases the blood flow and blood velocity in the inner ear, keeping the body's vegetative, endocrine and immune functions normal.The branches of the facial and linguopharyngeal nerves are connected to the inner ear, and local injection can nourish the nerves and improve local circulation.


Eligibility criteria: Inclusion Criteria:

* Meet the diagnostic criteria for sudden deafness established by the Editorial Board of the Chinese Journal of Otolaryngology, Head and Neck Surgery and the Chinese Society of Otolaryngology, Head and Neck Surgery
* Age 18 to 80 years
* ASA classification Ⅰ\~Ⅲ grade

Exclusion Criteria:

* Acoustic conductance test, vestibular function test, cranial MRI, etc. suggest organic disease
* People with coagulation disorders or on anticoagulation therapy
* Infection at the puncture site
* Severe systemic diseases that cannot cooperate with treatment

Primary outcomes:
measure: Mean Hearing Threshold (PTA)
timeFrame: Baseline (Before treatment)，1 month and 2 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University
state: Jiangsu
Study officials:
affiliation: The Affiliated Hospital of Yangzhou University
name: zhuan zhang, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05412784: Palliative Care Costs for Outpatient Setting Management in Catalunya
Official title: Palliative Care Costs for Oncologic and Non-oncologic Patients Under Different Outpatient Management in Catalunya
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Palliative Care
Cost and Cost Analysis
Outpatient
Keywords: Palliative Care [MeSH]
Cost and Cost Analysis [MeSH]
Outpatients [MeSH]
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
First posted: 2022-06-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a history of breast, lung, and colorectal neoplasm or Chronic Heart Failure (CHF) or Chronic Obstructive Pulmonary Disease (COPD), managed in the outpatient/domiciliary scenarios and their families/caregivers.

Brief summary: Cost-of-illness studies in palliative care (PC) are a growing area of interest in health economics activity. They are, in part, stakeholders' basis for deciding the allocation of the scarce public and private economic resources. There is no standard methodology to capture the formal and informal costs and expenses that health services and patients and their caregivers make during the PC attention period due to non-standard health services, and data capture approaches.

Detailed description: Methods / Analysis Prospective study on the burden of disease of PC on the outpatient/domiciliary attention. Proposed in three phases: Phase I: Systematic Review of Literature to identify de types of costs and proposed methodologies to identify and determine de economic burden of PC. With collected data, create a questionnaire to register the costs of services covered by the healthcare system and those covered by patients/caregivers (PROSPERO CRD42021250086). Phase II: Questionnaire piloting. Phase III: Transversal study of costs, collecting data from public healthcare billing and patient/caregivers payments to cover PC on selected patients. Final methodologic proposal to study billing/costs of outpatient/domiciliary PC.

Eligibility criteria: Inclusion criteria:

* Clinical diagnosis of breast, lung, and colorectal neoplasm or Chronic Heart Failure (CHF) or Chronic Obstructive Pulmonary Disease (COPD).
* Patient and caregivers must be able to maintain a 1-hour telephonic interview.
* Patient and caregivers must allow one (1) more telephone call to revise data.

Exclusion Criteria:

* Cases with an open legal process.
* Family/caregivers of patients that can't communicate in fluent Spanish or Catalan.

Primary outcomes:
measure: Determination of economic burden (costs) of palliative care in the outpatient context.
timeFrame: 6 months
Secondary outcomes:
measure: Type of costs.
timeFrame: 6 months
measure: Differentiate and compare costs.
timeFrame: 6 months -1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02905084: Multi-physics Modeling the Physiology of a Patient in Critical Condition
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient Care in ICU
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient in intensive care unit

Brief summary: The environment of the ICU and operating room allows the multi continuous monitoring of patients in critical situations. The physician anesthesiologist is working more and more in an environment where he receives a multitude of information from both the patient's medical history but also measured data in real time to its physiological situation. It is sometimes difficult for practitioners to consider all of the information by identifying a course of action. A decision support and a degree of automation can increase security along the lines of what has been observed in many processes and industries like aviation.

The goal of this project is to establish initially a database of physiological parameters. We want to use patient data to model physiological processes in order to advance towards the creation of "physios" program,


Eligibility criteria: Inclusion Criteria:

* Patient in intensive care unit ward

Exclusion Criteria:

* Patient or familly refusing participating to the study

Primary outcomes:
measure: Correlation between high blood pressure measurement during the first 24h in ICU and number of patient alive at 28 days post ICU
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
affiliation: michelsalah.boussen@ap-hm.fr
name: Salah BOUSSEN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02143284: A Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing a Full Spectrum Optical Technology
Official title: Single-Center, Exploratory Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Diseases
Lead sponsor: EndoChoice Innovation Center, Ltd.
Sponsor class: INDUSTRY
First posted: 2014-05-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: EndoChoice's FUSE System enables a wider view range via 1-2 additional cameras (depending on the model). These optical properties are to be examined and reviewed in this trial (mainly usability and safety)

Detailed description: EndoChoice Full Spectrum Optical Technology (FSOT) in gastrointestinal endoscopy enables a 330 degree field of view. FSOT powers EndoChoice's FDA, CE and AMAR (Israeli medical device authority) approved Endoscopic systems (Gastroscope and Colonoscope). The intent of this study is to evaluate the safety, performance and usability of additional versions of FSOT- powered gastroscopes and colonoscopes.

Eligibility criteria: Inclusion Criteria:

* Male and Female patients ages of 18-70
* The patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance.
* Signed informed consent

Exclusion Criteria:

* Patients with inflammatory bowel disease;
* Patients with a personal history of polyposis syndrome;
* Patients with suspected bowel stricture potentially precluding complete endoscopy
* Patients with a history of diverticulitis or toxic megacolon
* Patients with a history of radiation therapy to neck, abdomen, pelvis;
* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
* Patients with GI bleeding, that has not been corrected prior to endoscopy

Primary outcomes:
measure: Performance, usability and ease of use
timeFrame: 1 Year
Secondary outcomes:
measure: Safety
timeFrame: 1 Year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam medical center
Study officials:
affiliation: Rambam Medical Center Gastroenterological institute
name: Ian Gralnek, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03584984: Autogenous Bone Mixed With Xenograft Versus Xenograft Alone Versus Absorbent Gelatin Sponge
Official title: Alveolar Ridge Preservation in Mandibular Molars Using Mixture of Autogenous Bone & Anorganic Bovine Bone (ABB) Versus Anorganic Bovine Bone Alone Versus Absorbent Gelatin Sponge
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Resorption
Alveolar Bone Loss
Alveolar Bone Resorption
Bone Graft Failure
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Alveolar bone atrophy post-extraction has been well documented in the past years. normal healing event results in a minimal loss of vertical height (around 1 mm), but a substantial loss of width in the buccal-lingual plane (4-6 mm). Alveolar socket preservation is thought to deal with this issue as to prevent the loss of alveolar bone dimensions post extraction in the case of delayed implant placement


Eligibility criteria: Inclusion Criteria:

* Adult patients with hopeless mandibular molars indicated for extraction and implant placement in two stages that indicate socket preservation.
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Presence of fenestrations or dehiscence of the residual bony Walls after extraction.
* Heavy smokers more than 20 cigarettes per day .(24)
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to a history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
* Patients that refuse to be called back for implant placement post extraction.
* Patients that have exceeded bone resorption surrounding the tooth prior to extraction and require guided bone regeneration.
* Pregnant Females.

Primary outcomes:
measure: Histomorphometrical bone analysis
timeFrame: 6 month post primary surgery
Secondary outcomes:
measure: Alveolar Bone marginal loss
timeFrame: 6 month post primary surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02816502: Hippocampal Plasticity of Young Adults With Childhood Adversity
Official title: Hippocampal Plasticity of Young Adults With Childhood Adversity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: childhood
adversity
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2016-06-28
Enrollment: 73
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the clinical and neural effects of stress management skill building programs for young adults with childhood adversity. The investigators will recruit a total of 60 young adults (21-35 years old) who will be randomized into two different stress management skill building programs, both of which are 8 weeks long. MRI and psychological assessments will be acquired from all subjects before and after the intervention programs in order to investigate changes in clinical symptoms (such as depression, anxiety and stress) and hippocampus structure and function as well as other neural changes.


Eligibility criteria: Inclusion Criteria:

* having childhood adversity
* no history of psychiatric disorders of psychotic features or neurological disorders
* verified age between 21-35 years old;
* no suicidal attempts during the past six months;
* being determined by the clinician to have the capability to comply with the program requirements and not detrimental to other participants in the group;
* passing MRI eligibility criteria.
* provided written informed consent to participate in this study;
* committed to meeting the requirement of refraining from using marijuana or illicit drugs.

Exclusion Criteria:

* psychosis
* active suicidal attempts during the past 6 months
* psychoactive substance abuse
* MRI exclusion criteria

Primary outcomes:
measure: Changes in hippocampal subfield gray matter density measured with high resolution structural MRI at 3T
timeFrame: before and after the 8-week intervention
Secondary outcomes:
measure: Changes in stress level measured by the Perceived Stress Scale (PSS)
timeFrame: before and after the 8-week intervention
measure: Changes in severity of depression symptom measured by Beck Depression Inventory (BDI)
timeFrame: before and after the 8-week intervention
measure: Changes in severity of anxiety symptom measured by State-Trait Anxiety Inventory (STAI)
timeFrame: before and after the 8-week intervention
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Diane Joss, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06086002: Clinical Feasibility of Microwave Ablation Using Two Channel Microwave Generator and Two Antennas for Small Hepatocellular Carcinoma
Official title: Evaluation of Clinical Feasibility of Microwave Ablation Using Two Channel Microwave Generator and Two Antennas for Small Hepatocellular Carcinoma: A Preliminary Prospective Single Center Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare safety and efficacy of microwave ablation with simultaneous ablation using two antennas versus overlapping ablation with single antenna for small hepatocellular carcinoma


Eligibility criteria: Inclusion Criteria:

* Child-Pugh Class A or B
* chronic hepatitis B or chronic hepatitis C or liver cirrhosis
* presence of hepatocellular carcinoma (HCC) confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to Liver Imaging Reporting and Data System (LI-RADS) v2018
* single lesion less than or equal to 3 cm, or up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment

Exclusion Criteria:

* number of recurrent HCCs, equal or more than 3
* largest recurrent HCC size over 3 cm
* presence of vascular invasion by HCC
* diffuse infiltrative type HCC
* HCCs located less than 5 mm from central bile duct or large portal vein or large hepatic vein
* platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
* presence of extrahepatic metastasis

Primary outcomes:
measure: Technical success
timeFrame: Immediately after ablation
measure: Technique efficacy
timeFrame: 1 month after ablation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01018602: PINGUIN (Postpartum Intervention in Women With Gestational Diabetes Using Insulin)
Official title: A Phase II, Randomized, Double-blind, 2-arm Controlled Study to Evaluate Efficacy of the DPPIV-inhibitor Vildagliptin for Prevention of Type 2 Diabetes in Women With a Recent History of Insulin-requiring Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Insulin-dependent Gestational Diabetes
Lead sponsor: Institut fur Diabetesforschung, Munich, Germany
Sponsor class: OTHER
First posted: 2009-11-23
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to prove the efficacy of the oral intake of vildagliptin in a daily dose of 100 mg in scope of the development of type 2 diabetes in women with insulin dependent gestational diabetes in their last pregnancy not longer than 9 months after birth.

In this randomized, placebo-controlled, double-blinded clinical phase II study, 140 participants aged 18 years or older and an insulin dependent gestational diabetes in their last pregnancy should be included and treated with vildagliptin or placebo over 24 months, followed by a 12 months observation period. Exclusion criteria are pregnancy and lactation as well as a clinical overt diabetes or islet autoimmunity.

The null hypothesis is that there is no significant difference of diabetes incidence (according to ADA criteria 1997) in both groups.

Primary endpoint is the clinical manifestation of diabetes, secondary endpoints include the improvement of beta cell function (evaluable by C-peptide measurement) and of insulin sensitivity by the treatment with vildagliptin.


Eligibility criteria: Inclusion Criteria:

* women with insulin-dependent gestational diabetes during the last pregnancy
* \< 9 months after delivery
* age 18 years or older
* contraception during intervention period (at least 24 months)

Exclusion Criteria:

* pregnancy or lactation
* GADA or IA-2A positivity
* clinical overt diabetes

Primary outcomes:
measure: development of type 2 diabetes mellitus by criteria of ADA 1997
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Institut fuer Diabetesforschung
Study officials:
References:
citation: Hummel S, Beyerlein A, Pfirrmann M, Hofelich A, Much D, Hivner S, Bunk M, Herbst M, Peplow C, Walter M, Kohn D, Hummel N, Kratzsch J, Hummel M, Fuchtenbusch M, Hasford J, Ziegler AG; PINGUIN Study Group. Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled study. Mol Metab. 2018 Mar;9:168-175. doi: 10.1016/j.molmet.2017.12.015. Epub 2018 Jan 3.