louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05341934: Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients
Official title: Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cognitive Intervention to Modify Addiction Behaviour of Alcohol-dependent Patients
Keywords: evaluative conditionning, addiction, alcohol, patients
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients


Eligibility criteria: Inclusion Criteria:

* Participants in this study will be patients:
* With an alcohol use disorder according to DSM 5
* Follow-up at the Laborit Hospital Center
* Aged between 18 and 70 years with informed consent after receiving written information
* Engaged in a process to reduce alcohol consumption
* With a score of MOCA\> 20
* Whose mother tongue is French
* Patients benefiting from social security or benefiting from it through a third party in accordance with the french law on research involving the human person.

Exclusion Criteria:

* - Patient with less than 6 Heavy Drinking Days in the month
* Patient with Schizophrenia
* Patient with bipolar disorder Type 1
* Patient with Korsakoff syndrome or degenerative neurological disorder
* Patient with hearing impairment, uncorrected visual impairment
* Patient under curatorship or guardianship
* Patient with addiction to another substance other than tobacco
* Patient already enrolled in another interventional study
* Pregnant or nursing woman
* Patient with difficulties of expression or comprehension in French
* Patients in emergency situations or unable to give their consent.

Output Criteria:

* Patient who has manifested verbally or in writing, the desire to leave the study in progress.
* Patient who will be hospitalized during the study for a problem related to his addiction.

Primary outcomes:
measure: The reduction of automatic or implicit associations of Alcohol with positive affect.
timeFrame: baseline
Secondary outcomes:
measure: The reduction in the total amount of alcohol consumed
timeFrame: week 2
measure: The reduction in the total amount of alcohol consumed
timeFrame: month 3
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
Study officials:
affiliation: Centre Hospitalier Henri Laborit
name: JAAFARI NEMATOLLAH, PROFESSOR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00264134: Docetaxel, Irinotecan, and Carboplatin in Extensive Stage Non-Small Cell Lung Cancer
Official title: A Phase I/II Trial: Docetaxel, Irinotecan, and Carboplatin in the Treatment of Extensive Stage Small Cell Lung Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer
Extensive Stage Unresectable
Keywords: Non-Small Cell Lung Cancer
Lead sponsor: Kentuckiana Cancer Institute
Sponsor class: OTHER
First posted: 2005-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective: To determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.

Secondary Objective: To evaluate the dose-related toxicities of this triple regimen in patients with inoperable lung cancer.

Detailed description: A phase I/II dose escalating study to determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.

Eligibility criteria: Inclusion Criteria:

* 18 years or older unresectable lung cancer measurable or evaluable lesions Karnofsky PS greater than or equal to 60%

Exclusion Criteria:

* untreated CNS metastases

Primary outcomes:
measure: Primary Objective: To determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.
Secondary outcomes:
measure: Secondary Objective: To evaluate the dose-related toxicities of this triple regimen in patients with inoperable lung cancer.
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kentuckiana Cancer Institute
state: Kentucky
Study officials:
affiliation: Kentuckiana Cancer Institute
name: Shawn Glisson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05633134: Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes
Official title: Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Embolization
Pelvic Tumor
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to assess the efficacy of precision preoperative embolization in decreasing operative blood loss, reducing surgical complications in pelvic tumor surgery. Furthermore the study aims at describing the vascularity in a series of pelvic tumors, and to correlate this with perioperative blood loss.

Detailed description: The main purpose of this study is to assess the efficacy of precision preoperative embolization in decreasing operative blood loss, reducing surgical complications in pelvic tumor surgery，which including poor wound healing，nerve injury，and pelvic organs dysfunction. Furthermore the study aims at describing the vascularity in a series of pelvic tumors,which contains four grade：poor，moderate，rich and abundant and to correlate this with perioperative blood loss.

Eligibility criteria: Inclusion Criteria:

* Primary or metastatic pelvic tumor
* Confirmed by contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) of the pelvic
* Planned surgical resection

Exclusion Criteria:

* Contrast medium allergy
* Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Primary outcomes:
measure: Perioperative blood loss
timeFrame: Measured intraoperatively
Secondary outcomes:
measure: Adverse events related to angiography or embolization
timeFrame: Within 2 postoperative days
measure: Adverse events related to surgery
timeFrame: Within 30 postoperative days
measure: Vascularization grade of pelvic tumors
timeFrame: At the angiographic procedure prior to embolization performed 0-24 hours before surgery
measure: postoperative blood loss
timeFrame: Within 2 postoperative days
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: XIN ZHI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06721234: Role of Femoral Vein Wall Thickness and Inflammatory Markers in Patients With Behcet Disease
Official title: Role of Femoral Vein Wall Thickness and Inflammatory Markers in Patients With Behcet Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Behçet
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: Evaluation of femoral vein wall thickness and inflammatory indices in patients with Behcet disease and assessment of their relation to the disease activity and related some clinical manifestations


Eligibility criteria: Inclusion Criteria:

* Patients fulfill the International Criteria for Behcet's Disease (ICBD)
* Age above 18 years old
* Patients cooperative and can answer questions
* Patients who are able and willing to give informed consent

Exclusion Criteria:

* Other rheumatological and vascular diseases
* Patients with abnormal hepatic or renal function tests , hyperlipidemia and impaired coagulation tests
* Patients with hypertension , diabetes mellitus , malignant and active infectious diseases
* Patients who are using aspirin and other platelet active drygs during the previous 6 months
* patients who are not able and willing to give written consent

Primary outcomes:
measure: Femoral Vein Wall thickness
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
References:
Clinical trial NCT05878834: Efficacy and Safety of Beta-glucan Supplement in Chronic Obstructive Pulmonary Disease Patients
Official title: Efficacy and Safety of Beta-glucan Supplement in Chronic Obstructive Pulmonary Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease Patients
Keywords: chronic obstructive pulmonary
beta-glucan
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objectives of this study are to evaluate Efficacy and safety of beta-glucan supplement in chronic obstructive pulmonary disease patients.

Detailed description: There are 72 patients in this study. They are randomly divided into 2 groups which are beta-glucan supplement group and placebo group. The supplement will be taken 1 capsule/day for 12 weeks. Forced expiratory volume in 1 second/Forced vital capacity, Modified Medical Research Council Dyspnea Score, Breathlessness, Cough, and Sputum Scale, 6 Minute Walk Test, Diffusing capacity for carbon monoxide, Tumor necrosis factor alpha, Interleukin-6, C-reactive protein, glutathione, aspartate transaminase, alanine transaminase, alkaline phosphatase, creatinine, and blood urea nitrogen are assessed before and after taking supplement 6 and 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Age more than 18 years
* Chronic Obstructive Pulmonary Disease with Forced expiratory volume in 1 second/Forced vital capacity after receiving bronchodilator medicine more than 70%
* No exacerbation and uncontrolled disease
* 10 pack-years smoking history 10 pack-years but stop smoking more than 1 years
* Willing to participate in this study

Exclusion Criteria:

* Respiratory infection in 4 weeks
* Lung cancer
* Liver disease or kidney disease
* Lung surgery history
* Take kung supplement in 2 weeks
* Take warfarin, clopidogrel, aspirin, or digoxin
* Allergic to beta-glucan, broccoli, or quercetin
* Cannot use Spirometry
* Pregnancy and lactation

Primary outcomes:
measure: Forced expiratory volume in 1 second/Forced vital capacity
timeFrame: 12 weeks
Secondary outcomes:
measure: Modified Medical Research Council Dyspnea Score
timeFrame: 12 weeks
measure: Breathlessness, Cough, and Sputum Scale
timeFrame: 12 weeks
measure: 6-minute walk test
timeFrame: 12 weeks
measure: Chronic obstructive pulmonary disease assessment test
timeFrame: 12 weeks
measure: Tumor necrosis factor alpha
timeFrame: 12 weeks
measure: Interleukin-6
timeFrame: 12 weeks
measure: C-reactive protein
timeFrame: 12 weeks
measure: Aspartate transaminase
timeFrame: 12 weeks
measure: Alanine transaminase
timeFrame: 12 weeks
measure: Alkaline phosphatase
timeFrame: 12 weeks
measure: Creatinine
timeFrame: 12 weeks
measure: Blood urea nitrogen
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Chulalongkorn University
name: Pornanong Aramwit, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00811434: Study of Lactulose in Children With Chronic Liver Disease
Official title: Improvement of Cognitive Function and Healthcare -Related Quality of Life After Lactulose Treatment in Children With Chronic Liver Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Minimal Hepatic Encephalopathy
Keywords: encephalopathy
pediatric liver disease
pediatric cirrhosis
serum ammonia levels
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2008-12-19
Enrollment: 16
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developmental testing we will determine if patients have MHE. If so, we will trial 3 months of blinded placebo or Lactulose treatment followed by a washout period with no treatment. At this time patients are re-tested and then begin another three month period switching to the opposite treatment of first 3 months.Final cognitive/developmental testing will determine if Lactulose treatment has any effect on MHE.

Detailed description: In addition ,serum ammonia levels will be obtained at beginning of study,post-washout and at end of study to evaluate Lactulose effect on serum ammonia.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of MHE as result of cognitive, developmental testing, pediatric pt. with cirrhosis as evidenced by imaging/biopsy

Exclusion Criteria:

* patients with neurological,psychiatric or unstable medical conditions which may contribute to impaired cognitive function.
* patients with known hearing or vision difficulties.
* those patients who do not speak English will be excluded.

Primary outcomes:
measure: Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis
timeFrame: baseline
Secondary outcomes:
measure: Health Related Quality of Life (HRQOL)
timeFrame: baseline
measure: Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function
timeFrame: before and after each treatment period
Other outcomes:
Locations:
city: INdianapolis,
country: United States
facility: James Whitcomb Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University
name: Girish Subbarao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04831034: 68Ga-FAPI PET/CT in Patients With Various Fibrotic Disease
Official title: 68Ga-DOTA/NOTA-FAPI PET/CT in Patients With Various Fibrotic Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Fibrosis
Positron-Emission Tomography
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the potential value of 68Ga-FAPI-04 positron emission tomography/ computed tomography (PET/CT) for the diagnosis and prognosis in fibrotic disease

Detailed description: Subjects with fibrotic disease underwent 68Ga-FAPI-04 PET/CT scanning. Fibrosis lesion uptake was quantified by the maximum standard uptake value (SUVmax). Subjects also received the conventional clinical assessment for liver fibrosis, such as magnetic resonance imaging(MRI) , biopsy and blood biochemical indexes (BBI) testing. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-FAPI-04 PET/CT, MRI and BBI were calculated and compared to evaluate the diagnostic efficacy.

Eligibility criteria: Inclusion Criteria:

* adult patients (aged 18 years or order)
* patients with suspected or new diagnosed fibrotic disease (supporting evidence may include , BBI, MRI, CT and pathology report)
* patients who had scheduled 68Ga-FAPI-04 PET/CT scan
* patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee

Exclusion Criteria:

* patients with pregnancy
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent

Primary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT05304234: Liver Cancer Disparities in American Indian and Alaska Native Persons
Official title: Liver Cancer Disparities in American Indian and Alaska Native Persons
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Cirrhosis, Liver
Hepatitis B
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Cherokee Nation Health Services
name: Alaska Native Tribal Health Consortium
First posted: 2022-03-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: we are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.
Primary purpose: SCREENING

Brief summary: We are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.

Detailed description: We are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.

We will compare the aMRI vs. the US arm with respect to the following outcomes:

1. Compliance/feasibility of conducting all three screening tests (0, 6 and 12 months) - Primary Outcome
2. Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system - Primary Outcome
3. Proportion diagnosed with HCC and stage at diagnosis - Secondary Outcome

Eligibility criteria: Inclusion Criteria:

* Cirrhosis, any etiology, or chronic HBV infection
* High risk of HCC
* Age 18-75
* Competent to provide informed consent

Exclusion Criteria:

* Prior diagnosis of HCC
* Current suspicion of HCC
* Prior receipt of any organ transplantation
* Participation in another HCC screening trial
* CTP score \>=10
* MELD-Na score \>20
* GFR\<30
* Poor life expectancy (\<5 years)
* Contraindication to MRI
* Inability to complete study visits
* Currently pregnant

Primary outcomes:
measure: Compliance with screening protocol
timeFrame: 12 months
measure: Feasibility of screening protocol
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tahlequah
country: United States
facility: Cherokee Nation Health Service
state: Oklahoma
Study officials:
affiliation: University of Washington
name: George Ioannou, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01883934: Frozen Embryo Donation Study
Official title: Increasing the Use of Donated Embryos: A Demonstration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: In Vitro Fertilization (IVF)
Embryo donation
Lead sponsor: Boston IVF
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: Brandeis University
First posted: 2013-06-21
Enrollment: 3568
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to improve patient understanding of and interest in donating frozen embryos resulting from in vitro fertilization (IVF) to others undergoing infertility treatment.

Detailed description: The first phase of this study involves the mailing of a survey to current Boston IVF patients who have embryos frozen in storage. A survey will be sent to these individuals to assess their knowledge and understanding of frozen embryos and if they would be interested in embryo donation.

The second phase of research will randomize these patients into two groups: control and intervention. The control groups will receive their standard of treatment regarding frozen embryos, which consists of receiving a yearly storage bill. The intervention group will receive a letter from their physician of record and a follow up phone call from a research assistant offering the opportunity to schedule a consult with a licensed social worker at Boston IVF. The consult is meant to serve as a chance to discuss the difficult decision around embryo disposition. The consult for these patient will be free of charge, covered with funds from our grant. Additional enhanced support services and educational services provided by embryologists, nurses and physicians in the Frozen Embryo Donation Service will be offered. These enhanced services will also be free of charge to subjects.

The third phase of the study includes the mailing of a letter to a random sample of patients with embryos frozen in storage at Boston IVF. This letter will be an invitation to contact Boston IVF to schedule a consult with a licensed social worker to discuss embryo disposition options. The consult for these patient will be free of charge, covered with funds from our grant.

Eligibility criteria: Inclusion Criteria:

* Patient at Boston IVF with embryos frozen in storage

Primary outcomes:
measure: Increase in embryo donation
timeFrame: Approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Boston IVF
state: Massachusetts
Study officials:
affiliation: Boston IVF
name: Alison Zimon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zimon AE, Shepard DS, Prottas J, Rooney KL, Ungerleider J, Halasa-Rappel YA, Sakkas D, Oskowitz SP. Embryo donation: Survey of in-vitro fertilization (IVF) patients and randomized trial of complimentary counseling. PLoS One. 2019 Aug 15;14(8):e0221149. doi: 10.1371/journal.pone.0221149. eCollection 2019.