louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03534388: A Feasibility Study to Evaluate Skin Cleansing With a Sodium Hypochlorite Wash
Official title: A Feasibility Study to Evaluate a Skin Cleansing Regimen With a Sodium Hypochlorite Wash in Lower Extremity Arterial Bypass Graft Surgery or Femoral Endarterectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Arterial Bypass Graft Surgery
Lead sponsor: TopMD Skin Care, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility comparing to retrospective data.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Feasibility study in approximately 20 subjects to investigate the rate of infection with subjects undergoing elective lower extremity arterial bypass graft surgery or femoral endarterectomy. The subjects are instructed to shower with the sodium hypochlorite body wash daily, or as modified by the physician, for 5 of the 7 days leading to their surgery.

Detailed description: This is a feasibility study in approximately 20 subjects over a 5-week period per subject. The study will investigate the rate of infection with subjects undergoing elective lower extremity arterial bypass graft surgery or femoral endarterectomy. The subjects are instructed to shower with the sodium hypochlorite body wash daily, or as modified by the physician, for 5 of the 7 days leading to their surgery.

Eligibility criteria: Inclusion Criteria:

1. Subject is male or female greater than the age of 18 years.
2. Subject is willing and able to give written informed consent and to comply with the requirements of the study.
3. Subject has 5 or more days of time prior to elective surgery scheduled to sign consent and begin washing parameters.
4. Subject is capable of taking a shower and lathering their entire body, or is able to be helped by a caregiver to shower each day with lather on their entire body for 5 out of 7 days immediately prior to elective surgery. (Modifications for bath usage can be made by the physician if the result of the product being left on the skin of the entire body for the time commitment is maintained, and if the body can be rinsed with poured water. Bed bath is not considered an allowable modification.)

Exclusion Criteria:

* 1) Subject is on antibiotics prior to surgery.

  2) Subject is unable to maintain washing regimen for the full study term.

  3) Subject is unable to follow pre-surgery cleansing instructions for 5 of the 7 days immediately prior to surgery. (Bed bath is not considered a cleansing day.)

Primary outcomes:
measure: Decrease in percentage
timeFrame: 5 week per subject
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Vascular Associates, PA
state: Texas
Study officials:
affiliation: Texas Vascular Associates
name: Stephen E Hohmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04471688: Multicenter Study on Detection Strategy of Infectious Diseases in Blood Transfusion
Official title: Multicenter Study on Detection Strategy of Infectious Diseases in Blood Transfusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infectious Disease Screening
Keywords: nucleic acid
pre-transfusion
pre-operative
pathogen detection
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: SANSURE BIOTECH INC.
First posted: 2020-07-15
Enrollment: 10000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study plans to test 10,000 clinical specimens

Brief summary: In the past ten years, nucleic acid detection technology has overcome the limitations of serological detection, reduced missed detections due to window period, occult infection, etc., and its application in the field of pathogen detection has developed rapidly. Since 2015, domestic blood collection and supply institutions have fully popularized nucleic acid testing. The safety screening of blood sources mostly adopts the method of combining two times of enzyme-free negative and one time of nucleic acid testing, which excludes the guarantee of blood safety to the greatest extent.

At present, the clinical pre-transfusion and pre-operative infectious disease screening in our country is still serological detection. The use of nucleic acid detection for infectious disease screening can better realize the significance of patients' pre-transfusion/pre-operative infectious disease screening. Therefore, this study will analyze the nucleic acid detection technology and clinical serological detection technology in order to solve three problems:

* Explore the best detection strategy for patients with pre-transfusion/pre-operative infectious disease screening; ② Explore the confirmation process of the gray area results of infectious disease serological testing; ③ Better realize the significance of screening for patients' infectious diseases.


Eligibility criteria: Inclusion Criteria:

* hosipital patients

Exclusion Criteria:

* No

Primary outcomes:
measure: Hepatitis B Infection Analysis result
timeFrame: 20190601-20201231
measure: Hepatitis C Infection Analysis result
timeFrame: 20190601-20201231
measure: HIV Infection Analysis result
timeFrame: 20190601-20201231
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: the Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT03656588: Does the Addition of Hydrogen Peroxide to Chlorhexidine Skin Prep to Treat P. Acnes in the Shoulder
Official title: Does the Addition of Hydrogen Peroxide to Chlorhexidine Preoperative Skin Preparation Reduce the Rate of Propionibacterium Acnes Positive Culture in the Shoulder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Propionibacterium Infection
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective, randomized controlled trial to evaluate the ability of hydrogen peroxide preparation in addition to chlorhexidine to decrease the colonization of Propionibacterium acnes(a bacteria commonly found in the dermis of the skin surrounding the shoulder in order to decrease postoperative joint infection.


Eligibility criteria: Inclusion Criteria:

1. All male patients (\>18) undergoing shoulder arthroscopy

Exclusion Criteria:

1. Female patients
2. Patients with active acne
3. Patients who have taken antibiotics within a month of their surgery
4. Subjects allergic to any of the following agents:

   o Benzoyl peroxide
5. Subjects with psoriatic/eczematous lesions on the shoulder girdle.

Primary outcomes:
measure: colonization of p.acnes in the dermis of the shoulder
timeFrame: 14 days in culture
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05415488: Dietary Treatment for IBS Within Primary Health Care
Official title: Dietary Treatment for IBS Within Primary Health Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention study with 2 parallel arms (1:1)
Primary purpose: TREATMENT

Brief summary: Irritable bowel syndrome (IBS) is a multifaceted disorder where diet plays a pivotal role in symptom generation and management. The traditional dietary advice given to patients in clinical settings are based on the NICE guidelines. Some of the advice included in these guidelines have limited scientific evidence. The aim of this study is to investigate the effectiveness of the traditional dietary advice in IBS, according to the NICE guidelines, within a primary health care setting, where treatment is delivered digitally and in groups of 8-12 individuals. As a sham comparator, one group will receive dietary advice according to the Swedish dietary guidelines regarding healthy eating habits.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with IBS (ROME IV) by physician
* Age 18-50
* Ability to read and understand Swedish
* Signed informed consent

Exclusion Criteria:

* Received dietary treatment for IBS previously
* Manifestations of other conditions that may explain gastrointestinal symptoms

Primary outcomes:
measure: Proportion of patients with significant symptom reduction
timeFrame: From baseline vs. 6 weeks after group session
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept of Internal Medicine, Sahlgrenska University Hospital
Study officials:
References:
Clinical trial NCT06549088: Analysis of Lung Cancer Tissue With Spatial Frequency Domain Imaging
Official title: Analysis of Lung Cancer Tissue With Spatial Frequency Domain Imaging
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lung Diseases
Cancer, Lung
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes adults undergoing surgical resection of a suspected or confirmed lung mass.

Brief summary: This study investigates if a new imaging device can detect different types of lung tissue using spatial frequency domain imaging (SFDI). Specifically, this study aims to detect lung nodules within normal lung tissue and determine if lung nodules are cancerous. Patients who have confirmed or suspected lung nodules and who are undergoing resection of those nodules will be recruited for the study. Study participants will undergo standard of care lung nodule resection in the operating room, and the resected specimen will be imaged using the SFDI device immediately after removal from the surgical field. The data captured from the SFDI images will then be compared to the pathology findings to identify optical properties of normal and cancerous lung tissue. Because the intervention is conducted on resected biospecimens, this study yields minimal risk to participants.


Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 18 years old
* Suspected or confirmed lung nodule on diagnostic imaging
* Undergoing lung resection using an open, endoscopic, or robotic approach
* Standard of care orders placed for a pathology assessment of resected lung tissue
* Adults undergoing lung resection for a lung mass

Exclusion Criteria:

* \<18 years old
* Pregnant females and incarcerated individuals
* No standard of care orders to obtain a pathology assessment
* RUSH pathology order for resected lung tissue
* Any condition where the principal investigator determines to impact patient safety or quality of care

Primary outcomes:
measure: Markers of native lung parenchyma
timeFrame: May 7, 2023 to December 31, 2026
Secondary outcomes:
measure: Cancer identification
timeFrame: May 7, 2023 to December 31, 2026
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
References:
Clinical trial NCT01270178: Entecavir for Chronic Hepatitis B in Hepatocellular Carcinoma Patients Underwent Radiofrequency Ablation Therapy
Official title: Prospective Trial of Entecavir for Chronic Hepatitis B in Hepatocellular Carcinoma Patients Underwent Radiofrequency Ablation Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
Hepatocellular Carcinoma
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2011-01-05
Enrollment: 420
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic hepatitis B patients received RFA therapy for HCC

Brief summary: Persistent replication of HBV (47-55%) is frequently found in patients with HCC, which in turn leads to deterioration of liver reserve. Moreover, a large proportion of HCC patients who underwent curative therapy died from progressive liver decompensation rather than recurrence of cancer. It had been proved that anti-viral therapy for hepatitis C virus (HCV)-related HCC patients could reduce the rate of tumor recurrence after surgical resection.

This is a prospective study to evaluate the efficacy of ETV therapy in chronic hepatitis B patients after receiving RFA therapy for HCC.


Eligibility criteria: Inclusion Criteria:

* HCC diagnosed by pathology verification or in accordance with the guidelines of American Association for the Study of Liver Diseases published in 2010 (typical vascular pattern in computed tomography scan or magnetic resonance imaging study) ,
* Solitary tumor less than 5 cm in diameter or 2-3 tumors with the largest one no more than 3 cm in diameter,
* No extrahepatic metastasis,
* No radiological evidence of invasion into major portal vein or hepatic vein branches,
* Good liver reserve with Child-Pugh Class A or B,
* A platelet count of more than 50,000/mm3,
* Serum creatinine level ≤ 2 mg/dL,
* No previous treatment for HCC,
* Positive for serum hepatitis B surface antigen (HBsAg) for more than 6 months
* Positive serum HBV DNA using a Cobas Amplicor HBV monitor (Roche Diagnostic System, Basel, Switzerland).

Exclusion Criteria:

* Dual or multiple infections with hepatitis C virus, hepatitis D virus, or the human immunodeficiency virus,
* Other forms of liver disease such as alcoholic hepatitis, autoimmune hepatitis, Wilson's disease, hemochromatosis,
* Use of interferon alpha, thymosin or antiviral agents within 6 months preceding entry into the study,
* Women who are pregnant or nursing.

Primary outcomes:
measure: The survival rate and recurrence rate between patients receiving ETV therapy and those in historical control
timeFrame: 3 years
Secondary outcomes:
measure: HBV reactivation, incidence of ALT normalization, reduction of serum HBV DNA level, HBsAg loss and HBsAg seroconversion to anti-HBsAb, emergence of resistance.
timeFrame: 3 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Medicine, Taipei Veterans General Hospital
Study officials:
References:
Clinical trial NCT02087878: A Blood and Tissue Sample Collection Study of Patients Who Have Inflammatory Bowel Disease, Who Have Been Treated With Adalimumab and Who Developed Hepatosplenic T-Cell Lymphoma
Official title: A Multicenter Study to Collect Samples for Future Evaluation of Biomarkers and Genetic Mutations in Patients Exposed to Adalimumab With Crohn's Disease (CD) or Ulcerative Colitis (UC) Who Developed Hepatosplenic T-Cell Lymphoma (HSTCL)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Crohn's Disease
Ulcerative Colitis (UC)
Hepatosplenic T-Cell Lymphoma
Keywords: Hepatosplenic T-Cell Lymphoma
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-03-14
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include patients of any age with CD or UC in the US with HSTCL who are identified through the Sponsor's adverse event reporting systems and who were exposed to HUMIRA prior to the diagnosis of HSTCL.

Brief summary: To collect and store blood and biopsy samples obtained from CD or UC patients exposed to adalimumab and diagnosed with Hepatosplenic T-cell Lymphoma (HSTCL), for the purpose of identifying potential biomarkers and genetic mutations in patients who have developed HSTCL.

Detailed description: A study to bank samples for future evaluation to identify genetic mutations and other biomarkers that predispose inflammatory bowel disease (IBD) patients to developing Hepatosplenic T-cell Lymphoma (HSTCL).

Eligibility criteria: Inclusion Criteria:

* Male or female who has received a single dose of HUMIRA prior to a confirmed diagnosis of HSTCL.
* Confirmed diagnosis of CD or UC as documented by a Gastroenterologist or physician who diagnosed the CD or UC.
* Confirmed diagnosis of HSTCL as determined by a biopsy performed on a specimen taken from the patient.
* Patients 18 years old and older must voluntarily sign and date an IRB/EC approved Informed Consent Form. For patients younger than 18 years old, a parent or legal guardian is required to voluntarily sign and date an IRB/EC approved Informed Consent Form. Pediatric patients will be included in all discussions if possible, in order to obtain their assent.

Exclusion Criteria:

* Male or female who has not received at least a single dose of adalimumab prior to a confirmed diagnosis of HSTCL.
* Unconfirmed diagnosis of HSTCL, CD or UC, respectively.
* The patient or the patient's HCP is unwilling to participate in this study.
* The parents or legal guardians (in the case of patients younger than 18 years of age), who are unable and/or unwilling to consent to the patient's participation in this study.

Primary outcomes:
measure: Collection of Samples
timeFrame: Up to 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: AOU Pisana /ID# 208952
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04130178: Nerve Block of the Proximal Interphalangeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study
Official title: Nerve Block of the Proximal Interphalyngeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 48
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: Researchers will include 83 rheumatoid arthritis patients (either early or established) diagnosed after 2010 ACR/EULAR criteria with bilateral hand arthritis aged 18 or above. Nerve block to the neural bundle of the 2nd and 3rd PIPs will be done to one hand (the dominant in half of the participants and the non-dominant in the remaining). The other hand will be used as a control and injected subcutaneously with saline. Half ml of Bupivacaine will be injected through a 27G needle at the level of the volar proximal digital crease of the 2nd and 3rd PIP. The needle will be directed alternatively toward the two pedicles on both sides.

PIPs of the 2nd and 3rd fingers in both hands will be examined EULAR-OMERACT scoring system at 0, 2 weeks, and 2 months intervals. Visual analog scale (VAS) for each hand will be used at the same intervals. There are no certain conditions for medications and all the patients were using sDMARDS.

Detailed description: PIPs of the 2nd and 3rd fingers at the control group will be injected with .5 mL of saline on each joint through a 27G needle.

Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis patient according to ACR/EULAR criteria
* age \>18
* bilateral hand affection

Exclusion Criteria:

* peripheral neuropathy
* other chronic arthritis
* patient who did mastectomy or any other hand operation

Primary outcomes:
measure: Change in pain
timeFrame: 0 time after 2 weeks and after 2 months
measure: Change in the degree of inflammation
timeFrame: at 0 time after 2 weeks and after 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
affiliation: Sohag University
name: Ahmed Elsaman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00968578: Effects of Methylprednisolone After Total Knee Arthroplasty
Official title: Effects of Pre-operative Methylprednisolone (125mg iv) After Total Knee Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Postoperative Nausea and Vomiting
Sleeping Quality
Fatigue
Inflammatory Response
Keywords: Knee arthroplasty
Methylprednisolone
Post-operative pain
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2009-08-31
Enrollment: 48
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 purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after knee arthroplasty.

The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce pain and improve outcome.

Detailed description: In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total knee arthroplasty is still associated with postoperative pain and delayed rehabilitation. We therefore decided to evaluate the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome in a well defined fast-track setup after knee arthroplasty.

Eligibility criteria: Inclusion Criteria:

* Elective total knee arthroplasty
* Able to speak and understand danish
* Able to give informed consent

Exclusion Criteria:

* Alcohol or medical abuse
* Allergies to local anesthetics or methylprednisolone
* Age \< 18 years
* Daily use of opioids or glucocorticoids
* Pregnancy or breastfeeding (fertile women)

Primary outcomes:
measure: Postoperative pain
timeFrame: 48 hours + follow up
Secondary outcomes:
measure: Postoperative nausea and vomiting (PONV)
timeFrame: 48 hours + follow up
measure: Sleeping quality
timeFrame: 48 hours + follow up
measure: Inflammatory response
timeFrame: 48 hours + follow up
measure: Additional analgetics, antinausea agents and sleeping medicine
timeFrame: 48 hours + follow up
measure: Time in hospital
timeFrame: Until discharge
measure: Fatigue
timeFrame: 48 hours + follow up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
state: Hvidovre
Study officials:
References:
citation: Lunn TH, Kristensen BB, Andersen LO, Husted H, Otte KS, Gaarn-Larsen L, Kehlet H. Effect of high-dose preoperative methylprednisolone on pain and recovery after total knee arthroplasty: a randomized, placebo-controlled trial. Br J Anaesth. 2011 Feb;106(2):230-8. doi: 10.1093/bja/aeq333. Epub 2010 Dec 3.