louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05435599: Serum Regucalcin Level and Chronic Hepatitis B
Official title: Efficacy of Serum Regucalcin Level in Detecting Fibrosis in Chronic Hepatitis B Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Hepatitis b
Liver Fibrosis
Keywords: hepatitis b
fibrosis
regucalcin
liver
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients undergoing liver biopsy for chronic hepatitis b
Primary purpose: DIAGNOSTIC

Brief summary: This study, it was aimed to investigate the relationship between serum regucalcin level and liver fibrosis level in patients with CHB infection.

Detailed description: Chronic hepatitis B (CHB) infection continues to be an important health problem due to its high morbidity and mortality. For this reason, it is very important to determine the appropriate timing to start antiviral therapy in patients with CHB infection and to evaluate the stage of liver fibrosis in the treatment follow-up. Liver biopsy is the gold standard for detecting liver fibrosis. Although it is generally accepted to be a safe procedure, it can cause some serious complications. For this reason, in recent years, many studies have been conducted on new noninvasive tests in the evaluation of liver fibrosis. One of them is the serum regucalcin level. Studies have shown that serum regucalcin levels increase in liver damage, but there is no study in the literature comparing liver fibrosis and serum regucalcin levels in CHB infection. This study, it was aimed to investigate the relationship between serum regucalcin level and liver fibrosis level in patients with CHB infection.

Eligibility criteria: Inclusion Criteria:

* Being followed up with a diagnosis of chronic hepatitis B
* Not having a known history of liver disease who applied to our outpatient clinic for other reasons
* Having a liver biopsy
* ≥18 years

Exclusion Criteria:

* \<18 years

Primary outcomes:
measure: Comparison of serum regucalcin levels with liver fibrosis levels
timeFrame: Performing liver biopsies: 3 months, data collection: 1 month, writing the article: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Training and Research Hospital
Study officials:
References:
citation: Wei X, Yu H, Zhao P, Xie L, Li L, Zhang J. Serum regucalcin is a useful indicator of liver injury severity in patients with hepatitis B virus-related liver diseases. Braz J Med Biol Res. 2019 Sep 30;52(10):e8845. doi: 10.1590/1414-431X20198845. eCollection 2019.
citation: Yamaguchi M, Isogai M, Shimada N. Potential sensitivity of hepatic specific protein regucalcin as a marker of chronic liver injury. Mol Cell Biochem. 1997 Feb;167(1-2):187-90. doi: 10.1023/a:1006859121897.
Clinical trial NCT02676999: Clinical and Radiographical Analysis of the Distal Radioulnar Joint Following Implantation of a Scheker Total Distal Radioulnar Joint Prosthesis
Official title: Clinical and Radiographical Analysis of the Distal Radioulnar Joint Following Implantation of a Scheker Total Distal Radioulnar Joint Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scheker Total Distal Radioulnar Joint Prosthesis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient treated with a Scheker total distal radioulnar joint prosthesis and with a follow-up time between 12 and 60 months after primary implantation, who were willing and able to give written informed consent to participate in the study.

Brief summary: This project is set to describe by objective measures as the range of motion and weight-bearing ability of the distal radioulnar joint one to five years after primary implantation of a Scheker total distal radioulnar joint prosthesis.The range of motion and stability of the distal radioulnar joint (DRUJ) are important outcomes to preserve function, especially the pronation and supination. Unlike other ulnar endoprostheses that replace only the ulnar head, the Scheker prosthesis replaces the ulnar head, resurfaces the lesser sigmoid notch, and is semi-constrained in design.


Eligibility criteria: Inclusion Criteria:

* Patient treated with a Scheker total distal radioulnar joint prosthesis and with a follow-up time between 12 and 60 months after primary implantation
* Patient willing and able to give written informed consent to participate in the study

Exclusion criteria:

* Inflammatory disease (e.g. rheumatoid arthritis)
* Pregnant women
* German language barrier to complete the questionnaires
* Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
* Legal incompetence
* Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study

Primary outcomes:
measure: Primary outcomes of this study are active DRUJ range of motion (pronation and supination) and weight-bearing ability in neutral and pronated position.
timeFrame: Follow-up time between 12-60 months after primary implantation of the Scheker prothesis
Secondary outcomes:
measure: Secondary outcomes of this study are radiological parameters, pain level by Visual Analog Scale, objective functional parameters (passive stability, grip strength), subjective functional parameters, and complications affecting the examined wrist.
timeFrame: Follow- up time between 12-60 months after primary implantation of the Scheker prothesis
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Center for Reconstructive Surgery
state: ZH
Study officials:
References:
Clinical trial NCT04218799: Human Microbiome and Healthcare Associated Infections - Nursing Home Dwelling Older Veterans
Official title: Human Microbiome and Healthcare Associated Infections - Nursing Home Dwelling Older Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Human Microbiome
Keywords: intranasal mupirocin
topical chlorhexidine
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: VA Office of Research and Development
First posted: 2020-01-06
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the research is to find out the effect of commonly used topical antibiotics on the bacteria that live in the nose, throat and on the skin of older adults. In addition, the investigators want to determine if these topical antibiotics affect how bacteria are spread in Community Living Centers of the VA Maryland Health Care System.


Eligibility criteria: Inclusion Criteria:

* Age 50 years or older.
* Living in a participating nursing home for at least 80% of the past 3 months-
* Willing to provide anterior nares, posterior pharynx, skin and throat specimens over the study period.
* Willing to use intranasal mupirocin and topical chlorhexidine over a five day period.
* Provide signed and dated informed consent from subject or LAR.

Exclusion Criteria:

* Recent history of MRSA colonization
* Use of mupirocin nasal ointment in past 3 months
* Use of topical chlorhexidine in past 3 months
* History of an allergic reaction to chlorhexidine or mupirocin

Primary outcomes:
measure: Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization
timeFrame: 8 weeks
measure: Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization
timeFrame: 8 weeks
measure: Change in the Abundance of Gram Negative Bacteria on the Subclavian Skin After Decolonization
timeFrame: 12 months
measure: Change in the Abundance of Gram Negative Bacteria on the Femoral Skin After Decolonization
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Loch Raven VA Community Living Center
state: Maryland
city: Perry Point
country: United States
facility: Perry Point VA Community Living Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Mary-Claire Roghmann, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00308542: A Study of the Safety and Efficacy of SK-0503 for Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Macular Edema
Keywords: eye diseases
diabetic eye problems
Lead sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2006-03-29
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of intravitreal implant of dexamethasone for the treatment of diabetic edema.


Eligibility criteria: Inclusion Criteria:

* Diabetic macular edema
* Criteria for visual acuity and macular thickness are met

Exclusion Criteria:

* History of glaucoma
* Known steroid-responder
* Use of systemic steroids
* Use of Warfarin/Heparin
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
city: Chiba
country: Japan
city: Fukuoka
country: Japan
city: Gunma
country: Japan
city: Hokkaido
country: Japan
city: Kagawa
country: Japan
city: Kyoto
country: Japan
city: Mie
country: Japan
city: Miyazaki
country: Japan
city: Osaka
country: Japan
city: Shiga
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Sanwa Kagaku Kenkyusho Co., Ltd.
name: Clinical Study Group, Clinical Development Dept.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06705842: APPI-Cost Trial for Perforated Appendicitis
Official title: The APPI-Cost Trial: Cost Assessment of Povidone-Iodine Irrigation for Prevention of Intra-abdominal Abscess in Perforated Appendicitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Perforated Appendicitis
Keywords: Perforated Appendicitis
Povidone Iodine
Cost effectiveness
Intra-abdominal abscess
Appendectomy
Implementation science
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2024-11-26
Enrollment: 346
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: The purpose of this study to assess the clinical effectiveness and cost-effectiveness of povidone-iodine (PVI) irrigation in perforated appendicitis, to investigate barriers and facilitators to future implementation of PVI irrigation, and to collect costs and clinical and patient-reported outcomes among patients with non-perforated appendicitis.


Eligibility criteria: Eligibility for Enrollment

Inclusion Criteria:

* Plan to undergo appendectomy for acute appendicitis

Exclusion Criteria:

* Preoperative hemodynamic instability requiring ongoing infusion of vasopressors
* Allergy to iodine
* Uncontrolled hyper- or hypothyroidism
* Renal dysfunction
* Pregnant or breastfeeding
* Primary language neither English nor Spanish
* Lack of functioning telephone or email account
* Incarcerated or in police custody

Eligibility for Randomization

Inclusion Criteria:

* Enrolled in study preoperatively
* Intraoperative diagnosis of perforated appendicitis

Exclusion Criteria:

* Non-perforated appendicitis

Primary outcomes:
measure: Cost-effectiveness of PVI relative to usual care
timeFrame: 90 day follow up
Secondary outcomes:
measure: Total patient-reported costs
timeFrame: 30 days, 90 days, 6 months, and 12 months
measure: Health-related quality of life as assessed by the EQ-5D-5L questionnaire
timeFrame: 30 days, 90 days, 6 months, and 12 months
measure: Index admission total hospital costs
timeFrame: Index admission (variable duration)
measure: 90-day total hospital costs
timeFrame: 90 day follow up
measure: Index admission total length of hospital stay
timeFrame: Index admission (variable duration)
measure: 90-day total length of hospital stay
timeFrame: 90 day follow up
measure: Number of days of work missed by participant
timeFrame: 12 months
measure: Postoperative complications
timeFrame: 90 days follow up
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Dalya Ferguson, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00890942: Efficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal Morphine Induced Pruritus After Cesarean Section
Official title: Efficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morphine Adverse Reaction
Keywords: pruritus
intrathecal morphine
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2009-04-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether intramuscular naloxone 0.4mg. is effective in prophylaxis of intrathecal morphine induced pruritus after cesarean section.


Eligibility criteria: Inclusion Criteria:

* patient schedule for cesarean section ASA class 1

Exclusion Criteria:

* have contraindication for spinal block
* complicated pregnancy
* have history of drug abuse during pregnancy
* obesity BMI\>35kg./m2

Primary outcomes:
measure: efficacy of intrathecal naloxone 0.4mg. in prophylaxis of intrathecal morphine induced pruritus after cesarean section
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Anesthesiology department, Siriraj Hospital, Mahidol University
Study officials:
affiliation: Anesthesiology department ,Siriraj hopital
name: Tachawan Jirativanont, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00452842: Safety FollowUp Study Of Cardiovascular Events In Subjects Who Participated In Selected Torcetrapib/Atorvastatin Studies
Official title: An Observational Safety Follow Up Trial Of The Occurrence Of Major Cardiovascular Events And All Cause Mortality In Subjects Who Participated In Selected Torcetrapib/Atorvastatin Clinical Trials.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiovascular Disease
Cerebrovascular Disorders
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-28
Enrollment: 26784
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: An observational safety follow up trial will be conducted to monitor the occurrence of cardiovascular events and all cause mortality in subjects who participated in selected torcetrapib/atorvastatin Phase 1, 2, and 3 clinical trials. No hypotheses will be tested.

Detailed description: Study A5091075, an observational study in subjects who had previously been treated with torcetrapib, was terminated on 20 Dec 2007. The study was terminated following reviews of final safety information from prior torcetrapib studies and the low participation rates observed during the recruitment period for study A5091075 . On the basis of this new information the Sponsor determined that it was unlikely that this study would result in new and scientifically valid information.

Eligibility criteria: Inclusion Criteria:

* Have signed informed consent prior to the initiation of any study-specific activities.
* Have participated in selected torcetrapib/atorvastatin Phase 1, 2, and 3 clinical trials and were treated with randomized study medication.

Exclusion Criteria:

* There are no exclusion criteria.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03844542: Therapeutic Plasma Exchange in the Treatment of Sepsis Associated Multi-Organ Failure [SAMOF-TPE]
Official title: Therapeutic Plasma Exchange in the Treatment of Sepsis Associated Multi-Organ Failure [SAMOF-TPE]
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Lead sponsor: Forsyth Medical Center
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 300
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: The investigators prospective, randomized adult clinical trial investigates the therapeutic efficacy of early therapeutic plasma exchange as adjunct treatment to standard therapy in patients with refractory septic shock and multiple organ failure.


Eligibility criteria: Inclusion Criteria:

* Adult patients are eligible for inclusion if they have sepsis with refractory shock and evidence of organ failure.

Exclusion Criteria:

* Persons who are pregnant
* Persons who are incarcerated
* Acute surgical catastrophe without potential for intervention or source control
* Cardiac arrest with unknown neurologic status, including patients being treated with therapeutic hypothermia
* Presence of severe acute brain injury or severe dementia
* Cardiogenic, neurogenic, obstructive, or post-cardiotomy shock
* Acute pancreatitis with no established source of infection
* Diabetic ketoacidosis as primary pathology

  * Note: Septic patients who develop DKA are eligible for inclusion. However, patients in whom organ dysfunction and hemodynamic instability are due primarily to volume depletion and acidosis from DKA should not be included.
* Need for mechanical circulatory support
* Prolonged acute illness with \> 24 hours of pressor needs at enrollment and/or end organ damage with further care deemed to be "futile."

  * NOTE: The time resets if a new inciting event leads to SAMOF.
  * For example, if a patient has sepsis stabilized but requires operative intervention for source control within the initial 24 hours of admission and returns to the ICU with SAMOF, the patient is again eligible for randomization for the next 24 hours.
* Bedbound state or poor baseline functional status with ECOG performance status score ≥ 3
* Underlying terminal illness/malignancy with \< 6 months life expectancy
* Advanced chronic liver disease/cirrhosis with evidence of portal hypertension
* Asplenia
* HIV with HARRT non-compliance

Primary outcomes:
measure: 28-Day Mortality
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04424342: Turkish Version of the Child Perceptions Questionnaire 8-10
Official title: Validity and Reliability of the Turkish Version of the Child Perceptions Questionnaire (CPQ8-10)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dentist-Patient Relations
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 418
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cross-sectional study. Patients applied for RTE University, Department of Pediatric Dentisry

Brief summary: The Child Perceptions Questionnaire (CPQ) is a widely used reliable measurement that provides for practitioners to assess child's current emotional, social, and functional well-being. The aim of the present study was to develop a translated version of CPQ8-10 into Turkish language and evaluate its reliability, validity, and reproducibility.

Detailed description: The CPQ8-10 was translated into Turkish as recommended in the literature. The intraclass correlation coefficient (ICC) was used for the test-retest reliability. The internal consistency was evaluated using Cronbach's alpha Coefficient. Construct validity and discriminant validity were calculated, exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were employed.

Eligibility criteria: Inclusion Criteria:

* being aged between 8 and 10 years,
* being mentally and physically sufficient to complete the questionnaire,
* having volunteered to participate in the study,
* speaking Turkish fluently,
* children who were attending their first visit to the dentist

Exclusion Criteria:

* those who were outside this age range (8-10),
* had physical, mental or systemic disabilities that prevented them from understanding and answering the CPQ8-10

Primary outcomes:
measure: Evaluation of the penultimate Turkish version of The Child Perceptions Questionnaire 8-10
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Nazife Begüm KARAN
state: Merkez
Study officials:
References:
Clinical trial NCT05013242: Goserline Acetate VS Dienogest in Endometriosi
Official title: Goserline Acetate Versus Dienogest in Treatment of Pain Associated With Endometriosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Endometriosis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: clinical trial aims to evaluate efficacy of dienogest (DNG) in comparison to goserline acetate in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis by laparoscopy and histopathology.

Detailed description: The study will be a clinical trial study of 12-week trial of GnRH (zoladex 3.75mg) injection once every 4 weeks and Visanne (dienogest 2mg) oral once daily for 12 weeks in patients confirmed endometriosis by laparoscopic surgery.

Pretreatment assessment, the patients will be questioned about their pelvic symptoms (dysmenorrhea, nonmenstrual pelvic pain, and deep dyspareunia) after taking full history and examination , The study will investigate and evaluate possible early, long side effects and efficacy of treatment to controlling the pain.

Eligibility criteria: Inclusion Criteria:

* Non pregnant women confirmed to have endometriosis by histopathology and not received any hormonal treatment yet. Also, medical treatment was the proper choice for treatment of each case.

Exclusion Criteria:

* Women suspect pregnancy.
* Breast feeding women.
* Previous use of hormonal agents (progestin less than 6 months, danazol less than 3 month, oral contraceptive pills less than 1 month before screening).
* Women with other gynecological pathology interfere with treatment we will use.
* Using of corticosteroids.
* Family history of osteoporosis.

Primary outcomes:
measure: number of patients with pain symptoms reduction
timeFrame: 12 week
Secondary outcomes:
measure: assessment change in pain severity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: الدقهلية
Study officials:
affiliation: Mansoura university faculity of medicine , obstetric and gyneclogy department
name: Alaa Mosbah
role: PRINCIPAL_INVESTIGATOR
References: