louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04775329: Primary Prophylaxis for Spontaneous Bacterial Peritonitis
Official title: Primary Prophylaxis for Spontaneous Bacterial Peritonitis in Decompensated Chronic Liver Disease With Small Bowel Bacterial Overgrowth: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Decompensated Cirrhosis
Small Bowel Bacterial Overgrowth Syndrome
Keywords: Rifaximin
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patient with liver cirrhosis commonly have co-existing small bowel bacterial overgrowth (SIBO) yet may be asymptomatic. It is unclear as to the value of treating SIBO in asymptomatic individuals. Cirrhosis increase permeability of the gastrointestinal mucosa. It is postulated that in cirrhosis, endotoxins translocate across the gut mucosal barrier resulting in a second hit within hepatocyte perpetuating decompensation and spontaneous bacterial peritonitis. We hypothesise that cirrhosis patients with concomitant SIBO are particularly vulnerable for endotoxin translocation and would benefit from treatment. Treatment of SIBO would reduce the risk of spontaneous bacterial peritonitis and other liver-related morbidities. We aim to treat a cohort of patients with severe liver disease and concomitant SIBO with antibiotics as prophylaxis and compare the risk of spontaneous bacterial peritonitis, further liver-related morbidity and survival against untreated asymptomatic controls.


Eligibility criteria: Inclusion Criteria:

* Decompensated liver cirrhosis (Childs B \& C) with ascites.
* Established diagnosis of SIBO

Exclusion Criteria:

* Known allergy to treatment drugs
* Inability to undergo test confirm the success of SIBO eradication;
* Pregnant or lactating women
* Terminal malignancy.
* Untreated Viral Hepatitis
* Alcoholic Liver disease with ongoing drinking.
* Respiratory Failure
* Recent antibiotics and proton-pump inhibitor within 30 days

Primary outcomes:
measure: Incidence of Spontaneous bacterial peritonitis
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of all liver related events (hepatic encephalopathy, variceal bleeding, acute on chronic liver failure)
timeFrame: 12 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Wong Yu Jun
Study officials:
affiliation: Changi General Hospital
name: YU JUN WONG, MD, MRCP FAMS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04614129: Lung Cancer Risk and Early Detection in Firefighters
Official title: Lung Cancer Risk and Early Detection in Firefighters
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Lung Diseases
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 850
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study will evaluate whether LDCT findings differ between firefighters and non-fighters, the relationship between occupational exposures and LDCT findings, and whether a proteomics assay can further risk-stratify screen-detected nodules among a study population of 850 current and retired firefighters and 1,120 matched controls.


Eligibility criteria: Inclusion Criteria:

* 40-80 years of age or with 10 years of firefighting experience
* Current or retired firefighters
* No personal history of lung cancer
* Willing and able to receive LDCT screening at MGH or who have been screened via LDCT within the past year at MGH or another institution, and are willing to release their images to the study

Exclusion Criteria:

* Any active cancer (undergoing treatment or diagnosed within the past 5 years)

Primary outcomes:
measure: Nodule detection rate
timeFrame: 12 months
measure: High-risk nodule detection rate
timeFrame: 12 months
Secondary outcomes:
measure: Interstitial lung disease detection rate
timeFrame: 12 months
measure: Coronary artery calcification (CAC) ordinal scores
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Erica T Warner, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Lecia V Sequist, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01475929: Effect of Probiotic Supplement on Bowel Function
Official title: Effect of Probiotic Supplement on Bowel Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: irritable bowel syndrome
probiotic
Lead sponsor: Danisco
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to analyse the effect of probiotic supplement on symptoms of irritable bowel syndrome.

Detailed description: The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on symptoms of irritable bowel syndrome (IBS). Fulfillment of Rome III criteria will be used as inclusion criterion. Subjective assessment of bowel symptoms, IBS-related quality of life and adequate relief will be assessed as outcome measures.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 18 to 65 with functional bowel symptoms and fulfilling Rome III criteria for IBS will be recruited. Sufficient general health and orientation for participating in the study is required and will be evaluated by the MDs.

Exclusion Criteria:

* Diagnosed or suspected organic gastrointestinal diseases or severely impaired general health are exclusion criteria.

Primary outcomes:
measure: Change in functional bowel symptoms
timeFrame: 0 weeks, 6 weeks, 12 weeks
Secondary outcomes:
measure: Change in quality of life
timeFrame: 0 weeks, 6 weeks, 12 weeks
measure: Adequate relief
timeFrame: Weekly over 3 month intervention
measure: Change in faecal microbiota
timeFrame: 0 weeks, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Herttoniemi Hospital
Study officials:
affiliation: Danisco
name: Arthur Ouwehand, PhD
role: STUDY_CHAIR
affiliation: Danisco
name: Anna Lyra, PhD
role: STUDY_DIRECTOR
affiliation: Helsinki Health Centre
name: Lea Veijola, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Danisco
name: Sampo Lahtinen, PhD
role: STUDY_CHAIR
affiliation: Danisco
name: Anneli Tarpila, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03072329: Neurostimulation in Pudendal Nerve Block
Official title: Neurostimulation in Pudendal Nerve Block: is That Really Necessary?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Penile Surgery
Lead sponsor: Hôpital d'enfants Béchir-Hamza
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 150
Sex: MALE
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to check whether the success rate of blind pudendal nerve block in penile surgery can be optimized by the search for a motor response during neurostimulation.


Eligibility criteria: Inclusion Criteria:

* Children scheduled for elective penile surgery (hypospadias / circumcision)

Non-inclusion Criteria:

* Association to further peripheral nerve blocks required

Primary outcomes:
measure: Nerve block success
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bab Saadoun
country: Tunisia
facility: Hôpital d'Enfants Béchir Hamza
state: Tunis
Study officials:
name: Ben Khalifa Sonia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01314729: Comparison of the Effect of Two Types of Fixed Retainers on the Health of the Gums
Official title: Clinical and Radiographic Comparison and Evaluation of Two Types of Lingual Fixed Retainers on the Health of Periodontium
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Health of Periodontium
Keywords: Orthodontic fixed retainer
fiber-reinforced-composite retainer
composite-wire retainer
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shiraz Dental School, Orthodontic Research Center
First posted: 2011-03-14
Enrollment: 48
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Different types of retainers have been used to assure the stability of orthodontic treatment. The aim of this study is clinical and radiographic comparison and evaluation of two common types of lingual fixed retainers on the health of periodontium.

The participants in this study will be examined both clinically and radiographically just after the completion of orthodontic treatment and after a 6-month-period.

The results of the study will be analyzed with Mann-whitney and independent t-test.


Eligibility criteria: Inclusion Criteria:

1. The patient who have completed orthodontic treatment
2. The patients should be healthy with no systemic disease at the time
3. In clinical examination no apparent periodontal disease or inflammation should be present
4. Patients who have complete permanent dentition (3rd molar eruption is not required)

Primary outcomes:
measure: Measuring periodontal status through clinical examination
timeFrame: approximately 20 months
measure: measuring PDL width in periapical radiographs
timeFrame: approximately 20 months
Secondary outcomes:
measure: Assessing periodontial status with Gingival Index
timeFrame: approximately 20 months
measure: assessing periodontal status using Plaque Index
timeFrame: approximately 20 months
measure: assessing periodontal status using Calculus Index
timeFrame: approximately 20 months
measure: assessing periodontal status using Bleeding on probing
timeFrame: approximately 20 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz Dental School
state: Fars
Study officials:
affiliation: Shiraz Dental School
name: Morteza Oshagh, Associate professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz Dental School
name: Sepideh Torkan, resident
role: PRINCIPAL_INVESTIGATOR
References:
citation: Torkan S, Oshagh M, Khojastepour L, Shahidi S, Heidari S. Clinical and radiographic comparison of the effects of two types of fixed retainers on periodontium - a randomized clinical trial. Prog Orthod. 2014 Aug 27;15(1):47. doi: 10.1186/s40510-014-0047-8.
Clinical trial NCT06077929: Optic Nerve Course Variants in Nepali Population
Official title: Evaluation of Variations of Optic Nerve Course in Relation to Posterior Paranasal Sinuses in MDCT at a Tertiary Care Center of Nepal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optic Nerve
Keywords: Optic Nerve Course
De Lano's Classification
Anterior Clinoid Process Pneumatization
Lead sponsor: Grande International Hospital, Nepal
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 367
Sex: ALL
Minimum age (years): 13
Maximum age (years): 94
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patient of age 13 years and more undergoing NCCT PNS and Head for chronic rhinosinusitis , headache and vertigo

Brief summary: A retrospective study was conducted on 367 patients. CT PNS and head of the patients were evaluated for type of course of optic nerve according to DeLano's Classification.

Detailed description: A retrospective study was conducted on 367 patients aged 13 years and above. Four investigators, each with 2 to 6 years of experience in the field of radiology, evaluated computed tomography scans of the paranasal sinuses and the head of these patients. The optic nerves were classified into four types based on DeLano's classification, and their respective prevalence rates were determined. Additionally, the prevalence of optic nerve dehiscence and pneumatization of the anterior clinoid process was assessed.

Eligibility criteria: Inclusion Criteria: Patients undergoing NCCT PNS and Head for chronic rhinosinusitis, headache and vertigo

Exclusion Criteria:

1. Patient less than 13 years age
2. Patients with recent trauma
3. Patient with large mass/ extensive polyposis

Primary outcomes:
measure: Prevalence of different types of optic nerve course
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Prajwal Dahal
state: Bagmati
Study officials:
affiliation: Grande International Hospital
name: PRAJWAL DAHAL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05855629: "A Comparative Clinical Evaluation of the Efficacy of Topical Adapalene, Benzoyl Peroxide Gel, Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule, and Their Fixed Combination in Mild to Moderate Acne Vulgaris Patients."
Official title: "A Comparative Clinical Evaluation of the Efficacy of Topical Adapalene, Benzoyl Peroxide Gel, Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule, and Their Fixed Combination in Mild to Moderate Acne Vulgaris Patients."
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: Treatment and Diagnostic Center of Private Enterprise "Asklepiy"
Sponsor class: OTHER
Collaborators: name: delta medical promotions ag
First posted: 2023-05-11
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to conduct a comparative clinical evaluation of the effectiveness of a fixed topical combination of adapalene with benzoyl peroxide in the form of a gel, a fixed combination of Lactobacillus rhamnosus, D-chiro-inositol and inulin in the form of capsules and their combination in patients with acne vulgaris of mild and moderate severity and laboratory lipid analysis profile of sebum, lipid metabolism, and IGF-1 (insulin-like growth factor).


Eligibility criteria: Inclusion Criteria:

* Patients with mild to moderate level of Acne Vulgaris

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: GAGS (Global Acne Grading System)
timeFrame: 180 days
Secondary outcomes:
measure: IGA (Investigator Global Assessment)
timeFrame: 180 days
Other outcomes:
Locations:
city: Uzhhorod
country: Ukraine
facility: TDC PE "Asklepiy"
state: Zakarpattia
Study officials:
References:
Clinical trial NCT00684229: Regional Anesthesia in Colon Rectal Surgery
Official title: Regional Anesthesia in Patients Undergoing Colon-Rectal Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colon Cancer
Keywords: Anesthesia; regional
Cancer recurrence
Anesthesia; inhalational
Analgesia; opioid
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-05-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will compare recurrence rates in patients with colorectal cancer who will be randomly assigned to epidural anesthesia/analgesia combined with general anesthesia or to general anesthesia followed by opioid analgesia.

Detailed description: The study population will consist of patients who are scheduled for open laparoscopic or laparoscopic assisted surgery for colon cancer. Patients will randomized into one of two groups. The intervention group will receive combined regional and general anesthesia during surgery. Postoperative pain treatment will be based on regional anesthesia techniques. The Control group will receive general anesthesia during surgery. Postoperative pain treatment will be based primarily on opioids. After surgery, patients will be followed daily during their hospital stay. Patients will be contacted by telephone every 6 months for five years. Quality of life questionnaires will be administered at these follow ups.

Eligibility criteria: Inclusion Criteria:

* Primary colon cancer without known extension beyond colon (T3, N0, M0)
* Scheduled for open, laparoscopic assisted and laparoscopic resection of the colon.
* Written informed consent, including willingness to be randomized to epidural anesthesia/analgesia or to sevoflurane general anesthesia and postoperative opioid analgesia.

Exclusion Criteria:

* Previous surgery for colon cancer;
* Any contraindication to epidural anesthesia or analgesia (including coagulopathy, abnormal anatomy);
* Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine;
* Age \<18 or \>85 years old;
* ASA Physical Status ≥4;
* Other cancer not believed by the attending surgeon to be in long-term remission;
* Systemic disease believed by the attending surgeon or anesthesiologist to present ≥25% two-year mortality.

Primary outcomes:
measure: cancer recurrence
timeFrame: 5 years
Secondary outcomes:
measure: length of post operative hospitalization
timeFrame: days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Dusseldorf
country: Germany
facility: University of Dusseldorf
Study officials:
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: STUDY_CHAIR
affiliation: The Cleveland Clinic
name: Andrea Kurz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05965180: Interstitial Assessment of Architectural Heterogeneity in Prostate Cancer Using a Fine Needle Photoacoustic Probe
Official title: Interstitial Assessment of Architectural Heterogeneity in Prostate Cancer Using a Fine Needle Photoacoustic Probe
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: Biopsy
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-07-28
Enrollment: 20
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with planned prostate biopsy procedures will be recruited through U-M Urology Clinics

Brief summary: In this project, we will integrate the Photoacoustic (PA) technology into a prostate biopsy procedure through a fine needle probe. The needle probe will be in the shape of a biopsy needle and compatible with the needle insertion mechanism in the transrectal ultrasound (TRUS) probe. When inserted into the prostate, the fine needle PA probe will assess the histological information in its surrounding tissue without any tissue extraction. The needle probe has been tested in prostate tissue samples and whole human prostates ex vivo.


Eligibility criteria: Inclusion Criteria:

* 1) Planned prostate biopsy as part of routine clinical care
* 2) \> 40 and \<80 years old

Exclusion Criteria:

* 1) Known history of bleeding disorders or
* 2) Patients taking anticoagulants, no matter doses or washout time
* 3) Known allergy to silicone material
* 4) Unable to provide informed consent
* 5) Either the surgeon or the patient do not think the patient will not be able to complete all parts of the study, the patient will be excluded
* 6) Involved in other investigational studies.

Primary outcomes:
measure: Demonstration of reliable measurements
timeFrame: day 1
Secondary outcomes:
measure: Determining the ability to observe differences between benign and cancerous regions
timeFrame: day 1
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Guan Xu, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01261780: MC-5A for Chemotherapy Induced Peripheral Neuropathy
Official title: Treatment of Painful Chemotherapy -Induced Peripheral Neuropathy With the MC-5A Pain Therapy Medical Device, a Randomized, Double-Blind, Sham-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuropathy, Paraneoplastic
Keywords: neuropathy,paraneoplastic
paraneoplastic peripheral neuropathy
pain
hyperalgesia
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 14
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: Painful chemotherapy induced peripheral neuropathy (CIPN) is a common complication of cancer therapy with few treatment options. CIPN is a complex side effect that varies between individuals and can be difficult to describe, difficult to treat and can significantly effect quality of life for patients.

The purpose of this study is to determine if patients with painful CIPN will have a decrease in pain scores after treatment with the MC-5A device.


Eligibility criteria: Inclusion Criteria:

* painful peripheral neuropathy resulting from chemotherapy
* pain must be present for minimum of 6 months
* must be able to read/understand English
* stable analgesics regimens allowed (no change for past 7 days)

Exclusion Criteria:

* painful peripheral neuropathy that is not the result of chemotherapy
* pregnant women
* patients unable to wean off anti-epileptics
* patients currently receiving chemotherapy known to cause peripheral neuropathy
* patients with pacemakers or implanted defibrillators
* patients with vena cava or aneurysm clips
* patients with a history of epilepsy

Primary outcomes:
measure: Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT)
timeFrame: Baseline, Visit 1 (Day 1), Vist 10 (Day 10), and End of Study (Week 12, +/- 2 weeks)
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Tony Campbell
role: PRINCIPAL_INVESTIGATOR
References: