louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04055870: Efficacy, Safety, and Adequacy of EUS-guided Liver Biopsy
Official title: Efficacy, Safety, and Adequacy of EUS-guided Liver Biopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatic
Liver Diseases
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 24
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: Age 18 years or older and have undergone EUS-guided liver biopsy at MDMC

Brief summary: The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients undergoing EUS-guided liver biopsy at Methodist Dallas Medical Center (MDMC).

Detailed description: The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients undergoing EUS-guided liver biopsy at Methodist Dallas Medical Center (MDMC). This is a clinical quality improvement (CQI) initiative to evaluate outcomes within our institution. The data collected will be used to inform new innovative ways to improve EUS-guided liver biopsy with an ultimate goal of improving the quality of patient care. The clinical outcomes of this patient population have not been previously systematically reviewed in MDMC. Currently, the procedure in not being performed routinely at Methodist Dallas Medical Center (MDMC). However, with new technical and physician expertise, this option is now available at our institution. PI will evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients requiring histologic examination of their liver at MDMC.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Undergone EUS-guided liver biopsy at MDMC

Exclusion Criteria:

* Below 18 years of age
* Did not undergo EUS-guided liver biopsy at MDMC

Primary outcomes:
measure: Length of core biopsy
timeFrame: 9/1/2017 and 9/1/2019
measure: Number of portal tracts
timeFrame: 9/1/2017 and 9/1/2019
measure: Diagnostic yield
timeFrame: 9/1/2017 and 9/1/2019
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Prashant Kedia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00171470: The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.
Official title: The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspepsia
Keywords: dyspepsia
hearburn
female
PPI
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to provide initial data to assess the safety and efficacy of tegaserod use in patients with dyspepsia that are being treated with proton pump inhibitors (PPI's) for heartburn.


Eligibility criteria: Inclusion Criteria:

* Female patients 18 years or older.
* Self-reported presence of symptoms consistent with dyspepsia (including mid-upper abdominal discomfort characterized by post prandial fullness, early satiety and bloating)
* Stable dose PPI therapy of at least 4 weeks

Exclusion Criteria:

* History of intestinal obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or of abdominal adhesions.
* Evidence that the dyspeptic symptoms are relieved by defecation and/or associated with a change in frequency or stool form.
* With a current most bothersome symptom of heartburn.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: To determine whether tegaserod administered over 6 weeks results in improved dyspeptic symptoms characterized by epigastric discomfort vs placebo on patients taking PPIs for the treatment of heartburn (weekly global assessment)
Secondary outcomes:
measure: Comparison of tegaserod vs. placebo for individual symptoms severity scores of postmeal fullness, early fullness while eating, bloating, abdominal pain, nausea, vomiting, heartburn, regurgitation and constipation (daily assessment)
measure: Quality of Life (weekly assessment)
measure: Safety and tolerability
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: http://www.novartisclinicaltrials.com/etrials/DiseaseID21/Dyspepsia-clinical-trials.go
state: New Jersey
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT06222970: Maxillary Sinus Augmentation Via the "Bone Lid Technique"
Official title: Maxillary Sinus Augmentation Via the "Bone Lid Technique"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Maxillary Deficiency
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients referred to the Unit of Dentistry and Oral Surgery, University Hospital of Pisa, with a severe bone atrophy of the maxillary posterior areas that required bone grafting through a lateral approach of the maxillary sinus

Brief summary: Maxillary sinus augmentation is one of the most performed procedures to increase the bone quantity of the atrophic maxilla in order to allow implant placement. The aim of the present case series was to describe a surgical protocol to perform maxillary sinus augmentation with the "bone lid technique", and its outcomes in a cohort of patients eligible for the procedure.


Eligibility criteria: Inclusion Criteria:

* Partially or fully edentulous patients requiring an implant-prosthetic rehabilitation of the premolar or molar maxillary areas with a residual ridge height lower than 4 mm.
* Patients needing for a unilateral or bilateral sinus lift with a lateral wall approach.

Exclusion Criteria:

* Patients under treatment with immunosuppressive agents
* Patients under treatment with medications that could impair bone metabolism.
* Patients pregnant or breastfeeding.
* Patients who had received irradiation treatment to the head and neck area.
* Patients with uncontrolled diabetes.
* Patients with uncontrolled periodontal disease.

Primary outcomes:
measure: Bone gain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: U.O. Odontostomatologia e Chirurgia del Cavo Orale
Study officials:
References:
Clinical trial NCT04527770: Midazolam Versus Dexamethasone as an Adjuvant to Local Anesthetics in the Ultrasound Guided Hydrodissection of Median Nerve for Treatment of Carpal Tunnel Syndrome Patients
Official title: Midazolam Versus Dexamethasone as an Adjuvant to Local Anesthetics in the Ultrasound Guided Hydrodissection of Median Nerve for Treatment of Carpal Tunnel Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Syndrome
Keywords: Midazolam
median nerve
dexamethasone
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 134
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups received hydrodissection sonar guided , one group received 50 mic/kg midazolam and the other received 8 mg dexamethasone
Primary purpose: TREATMENT

Brief summary: midazolam and dexamethasone both can counteract chronic pain. either via GABA mimetic action or via anti prostaglandins

Detailed description: Entrapement syndrome - namely median nerve compression in carpal tunnel syndrome - causes chronic pain that can be refractory to medical treatment . Ultrasound guided hydrodissection is an option for alleviating pain . Recurrence is the main side effect of injection. We try in this research to prevent recurrence rate . Midazolam and dexamethasone both are used in chronic pain . Midazolm act by GABA mimetic action while dexamethasone act by decrease interleukin formation

Eligibility criteria: Inclusion Criteria:

* numbness or pain in the nerve distribution, nerve conduction studies (NCS) corresponding with AANEM guidelines
* Nerve cross sectional area \>12mm2

Exclusion Criteria:

* Refusal to participate
* History of operation in median nerve.were patient refusal to participate, pain recurrence after previous injection and severe symptoms requiring surgical release, diabetic patients

Primary outcomes:
measure: comparing efficacy of midazolam against dexmethasone in combination with bupivacaine 0.5%
timeFrame: up to 6 months
Secondary outcomes:
measure: Subjective pain assesment
timeFrame: up to 6 months
measure: complications
timeFrame: pain recurrence after 6 months, neurotoxicity immediately after injection
measure: Nerve electrophysiology
timeFrame: up to 6 months
measure: nerve sonogram
timeFrame: up to 6 months
Other outcomes:
Locations:
city: ALMinya
country: Egypt
facility: Mina Maher Raouf
Study officials:
References:
Clinical trial NCT00817570: Evaluation of Balance Reactions of Transfemoral Amputees Using the Virtual Analysis System
Official title: Evaluation of Balance Reactions of Transfemoral Amputees Using the Virtual
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Balance
Keywords: Trans Femoral Amputees Balance Reactions
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-01-06
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Transfemoral Amputees and Able bodied.

Brief summary: The purpose of this study is to test and compare the balance reactions of Tranfemoral Amputees and able bodied subjects in response to perturbations given by a highly advanced Virtual Reality system.


Eligibility criteria: Inclusion Criteria:

* Transfemoral Amputees, walking without any assistive device, at least one year.

Exclusion Criteria:

* Amputees who suffer from a Neurological Injury/ disease that has implication on balance control.
* Amputees who suffer from Orthopedic Injury that has implication on balance control.
* Amputees who suffer from Cardiology disease that has implication on balance reactions.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat- Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT05617170: The Role of Early Rehabilitation in Improving Stroke Systems of Care
Official title: The Role of Early Rehabilitation in Improving Stroke Systems of Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Disorders
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * 50 case of acute cerebrovascular stroke patients will subject to implanted programme of early rehabilitation based on Telemedicine .
* 50 control Patient of acute cerebrovascular stroke will subject to ordinary rehabilitaion techniques .

Brief summary: 1. To assess the effect of implementing stroke early rehabilitation using telemedicine if avialable in the stroke unit of the Neurology Department , Assuit university hospitalis , Egypt.
2. Importance and impact of this programme on function and quality of life after stroke

Detailed description: In this case control study,we will analyzed Patients admitted to Neurology Depatment in assuit university hospitals from 1/2023 until 1/2024 and divide them in two groups , Group receive early rehabilitation services with the personnel get tele-rehab training and the other group get training with the usual pathway in the hospital by other personnel, and we could follow up the two groups for 3 months and comparing both groups .

Eligibility criteria: Inclusion Criteria:

1. Mild to Moderate stroke Patients (ischemic or hemorrhagic) admitted to AUH within 24 hour after admission.
2. ALL age Groups .
3. Both Sex.
4. Group receive rehab services with the personnel get tele-rehab training and the other group get training with the usual pathway in the hospital by other personnel, and we could follow up the two groups for 3 months and comparing both groups .

Exclusion Criteria:

Severe Stroke.

* Stroke Mimmics .
* Pregnancy.
* Stroke with severe hepatic ,renal and Pulmonary diseases limiting or affecting early rehabilitation .

Primary outcomes:
measure: • To assess the effect of implementing stroke early rehabilitation using telemedicine if avilable in the stroke unit of the Neurology Department , Assuit university hospitalis , Egypt.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Medicine , Assuit University , Egypt
name: Mohmed Ahmed, Proffessor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03492970: Melatonin in Adults With SMS
Official title: Characterization of Behavioral Disorders and 24 H-melatonin Level in Adults With Smith Magenis Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smith Magenis Syndrome
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2018-04-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To specify the evolution of the nycthéméral cycle of the secretion of melatonin in 10 adult subjects carrying a SMS
Primary purpose: SCREENING

Brief summary: Sleep-Wake and behavioral disorders in Smith Magenis Syndrome (SMS) are strongly linked to an inversion of the nychtemeral secretion of melatonin. This inversion have been described in children with SMS. However its evolution during adulthood remains unknown. The aim of this study is to assess 24hours melatonin levels in 10 adults with SMS in order to optimize medication in adults with SMS

Detailed description: SMS is one of the rare syndromes in which the inversion of melatonin secretion is regular, which is an exceptional situation for the study of the influence of genetic factors on the regulation of sleep / wake rhythm. Recently, point mutations of the RAI1 gene (Retinoic Acid Induced 1) have been identified in individuals with the clinical features of SMS with a reversal of the secretion rate of melatonin ,highlighting the role of RAI1 in SMS sleep disorders.

Daytime secretion of melatonin is associated with significant drowsiness and plays a major role in diurnal behavior disorders, especially in younger people. Conversely, the absence of nocturnal melatonin is a causal factor in the shortening and fragmentation of nocturnal sleep .

Basically, little is known about the mechanisms that explain the inversion of the secretion rate of melatonin in SMS.

These aspects, and in particular the nycthemeral reversal of the melatonin cycle, have been described in a population of children and we do not know how these disturbances evolve in adulthood

Eligibility criteria: Inclusion Criteria:

* Patient with Smith Magenis Syndrome aged 18 years or older
* subject or guardian having signed the consent

Exclusion Criteria:

* Pregnant women
* Minor subject
* Diagnosis of Smith Magenis syndrome not certain
* Taking benzodiazepines or related substances
* Taking betablockers
* Major behavioral disorders versus indicating participation in this study

Primary outcomes:
measure: 24h melatonin levels
timeFrame: 24 hours
Secondary outcomes:
measure: Analysis of actimetry
timeFrame: 15 days
Other outcomes:
Locations:
city: BRON Cedex
country: France
facility: CH Le Vinatier
state: Rhône-Alpes
Study officials:
affiliation: CH LE VINATIER
name: POISSON ALICE, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02722070: Processing Integration in Neurological Patients Using fMRI
Official title: Processing Integration in Neurological Patients Using fMRI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Inflammatory Demyelinating Polyradiculoneuropathy
Stroke
Anosognosia
Central and Peripheral Neurodegenerative Pathologies
Neuropsychiatric Conditions
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from central and peripheral neurological pathologies and conditions

Brief summary: The main objective of the study is to explore and map brain areas involved in processing and perception in patients suffering from neurological pathologies and condition. The investigators hypothesize for example, that a change (compare to healthy subjects) in the perceptual maps and body representation could be detected and characterize in patients suffering from impairments of peripheral nerve conduction.


Eligibility criteria: Inclusion Criteria:

* diagnosis of the investigated neuronal disease

Exclusion Criteria:

* contraindication for MRI scan
* pregnancy
* refusal to participate in the study

Primary outcomes:
measure: Hemodynamic responses by measurement of the Blood-oxygen-level dependence(BOLD) signal
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Arzy S, Overney LS, Landis T, Blanke O. Neural mechanisms of embodiment: asomatognosia due to premotor cortex damage. Arch Neurol. 2006 Jul;63(7):1022-5. doi: 10.1001/archneur.63.7.1022.
Clinical trial NCT03632070: Factors Related to Functional Recovery Using Brain Imaging of Stroke Patients
Official title: A Study on Factors Related to Functional Recovery Using Brain Imaging of Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 73
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ischemic stroke who were admitted to Samsung Medical Center and transferred to the Department of Physical and Rehabilitation Medicine

Brief summary: In this study, brain imaging predictive factors related to motor recovery will be investigated. Lastly, the prediction model will be established.


Eligibility criteria: Inclusion Criteria:

* Adults more than 19 years
* First-ever unilateral stroke
* Ischemic subacute stroke patients

Exclusion Criteria:

* Major active neurological disease or psychiatric disease
* Metallic implants in their brain
* Hemorrhagic stroke
* Bilateral lesions
* Recurrent stroke

Primary outcomes:
measure: Fugl-Meyer Assessment score at 3 months after stroke onset
timeFrame: 3 months after stroke onset]
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT02581670: Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer
Official title: Prospective Non-randomized Phase II Study on Stereotactic Body Radiation Therapy for Medically Inoperable Lung and Liver Oligometastases From Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Metastasis to Liver
Metastasis to Lung
Keywords: oligometastatic breast cancer
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigators designed a phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach.

Detailed description: Investigators designed a prospective phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) scheduled for oligometastatic breast cancer patients unsuitable for surgery with age major than 18 years old and with adequate performance status (ECOG), using VMAT RapidArc approach. The potential advantage of this technique is the ability to deliver a more selective irradiation to tumour's target while reducing doses to normal tissue, optimizing the therapeutic window.

Eligibility criteria: Inclusion Criteria:

* Patients aged \>18 years with ECOG 0-2
* Diagnosis of Breast Cancer
* DFI (Disease-free interval) \> 1 year
* No extrapulmonary and/or extrahepatic disease or other metastatic sites stable or responding after chemotherapy
* No life threatening conditions
* Lung and liver lesions \< 5 (with maximum diameter \< 5 cm)
* Chemotherapy completed at least 3 weeks before treatment
* Chemotherapy started at least 2 weeks after treatment allowed
* Systemic therapies other than chemotherapy allowed (i.e hormonal therapies and/or immunotherapy)
* Written informed consent

Exclusion Criteria:

* ECOG \> 2
* Pregnant women
* Patients with inability to consent

Primary outcomes:
measure: Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4
timeFrame: 3 years
measure: Local control of disease after SBRT according to EORTC questionnaire
timeFrame: 2 years
Secondary outcomes:
measure: Progression free survival using Kaplan-Meyer statistical curves
timeFrame: 2 months
measure: Overall survival using Kaplan-Meyer statistical curves
timeFrame: 2 months
measure: Quality of life at the end of the treatment with questionnaire EORTC QLQ C30
timeFrame: 2 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
affiliation: Istituto Clinico Humanitas
name: Fiorenza De Rose, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Clinico Humanitas
name: Tiziana Comito, MD
role: PRINCIPAL_INVESTIGATOR
References: