louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03252041: MRI & MRV in Pelvic Congestion Syndrome in Females
Official title: MRI & MRV in Pelvic Congestion Syndrome in Females
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Pain Syndrome
Keywords: PCS
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 25
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: females with chronic lower abdominal pain, signs and symptoms of pelvic congestion syndrome

Brief summary: To investigate the feasibility of MRI and MRV in diagnosis of pelvic congestion syndrome.

Detailed description: In the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment options and a lack of available resources. Their physicians were likewise perplexed, despite the endless acquisition of negative laboratory and imaging data as well as inconclusive consultations obtained. In the last 10 years, improved scientiﬁc understanding and increased physician awareness have lessened the confusion surrounding this condition and its distinct association with pelvic congestion syndrome (PCS). Furthermore, reﬁnements of medical and minimally invasive surgical solutions give affected patients more therapeutic choices today.

Since anatomical venous variations in the pelvis are common, it is important to know the anatomy of these vessels for treatment planning. Imaging is critical in the evaluation of pelvic varices, both to differentiate them from other condition and also because pelvic varices may be secondary to serious underlying pathology, such as inferior vena caval obstruction, portal hypertension, increased pelvic blood flow, and vascular malformations.

The diagnosis of PCS has usually been suggested by duplex ultrasound (US), but ultrasound imaging does not readily show the gonadal veins. Phlebography is the "gold standard" for anatomic diagnostic studies. Related mortality and morbidity are low, but patient discomfort and costs make this an unattractive routine method of diagnosis. Magnetic resonance imaging (MRI) can usually demonstrate pelvic and ovarian varices, as well as the gonadal veins.

In this prospective study, we will investigate the feasibility of using magnetic resonance venography (MRV) in the diagnosis of PCS and evaluated its accuracy and reliability in comparison to phlebography.

Eligibility criteria: Inclusion Criteria:

* All patients with signs and symptoms of PCS.

Exclusion Criteria:

* Patients with general contraindications to MRI as presence of any para-magnetic substance as pacemakers, or in severely ill patients or those with claustrophobia, arrhythmic patients.

Primary outcomes:
measure: MRI and MRV in pelvic congestion syndrome in females.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University, Egypt
name: Hossam Galal, ass prof
role: STUDY_CHAIR
References:
Clinical trial NCT04568941: Comparison Study of Different Tumor Biopsy Method for Sentinel Lymph Node Biopsy in Breast Cancer
Official title: Randomized Controlled Trial of Comparison of Tumor Biopsy Method of Preoperative Vacuum-Assisted, Core Needle Versus Intraoperative Excisional Biopsy for Sentinel Lymph Node Biopsy in Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Sentinel Lymph Node
Keywords: Sentinel Lymph Node
vacuum-assisted biopsy
Core needle biopsy
Breast Cancer
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cance, and the identified number of sentinel lymph nodes determines its accuracy for axillary status. Retrospective study indicated that preoperative tumor biopsy results in more detected sentinel lymoh nodes. The clinical trail is designed to compare the effect of three tumor biopsy methods (preoperative vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy) for sentinel lymph nodes.

Detailed description: OBJECTIVES:

Compare the identification rate of sentinel lymph node in breast cancer patients with different tumor biopsy methods.

Evaluate the false-negative rates of sentinel lymph nodes in patients with different tumor biopsy methods.

OUTLINE:

The patients were randomly divided into three group, vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy. Preoperative vacuum-assisted biopsy and core needle biopsy were performed in 10 days before the final surgery. All patients received dual tracer (radiolabeled colloid and blue dye) guided SLNB.

Eligibility criteria: Inclusion Criteria:

* clinically lymph node negative breast cancer patients T1-T3

Exclusion Criteria:

* history of breast cancer locally advanced breast cancer and metastatic breast cancer proven axillary lymph node metastasis history of axillary excisional or incisional biopsy, or dissection history of neoadjuvant chemotherapy pregnancy non-consented patients

Primary outcomes:
measure: Identification rates of sentinel lymph node biopsy
timeFrame: 1 year
Secondary outcomes:
measure: Identification numbers of sentinel lymph node biopsy
timeFrame: 1 year
measure: fase-negative rates of sentinel lymph node biopsy
timeFrame: 1 year
Other outcomes:
Locations:
city: Jinan
country: China
facility: Zhiyong Yu
state: Shandong
Study officials:
References:
citation: Yuan C, Wang X, Liu Z, Li C, Bian M, Shan J, Song X, Yu Z, Yu J. Preoperative tumor biopsy results in more detected sentinel nodes than intraoperative biopsy in breast cancer patients. World J Surg Oncol. 2020 Jul 21;18(1):178. doi: 10.1186/s12957-020-01942-4.
Clinical trial NCT01868841: 123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging on a Small Field of View-High Efficiency Cardiac SPECT System
Official title: 123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Cardiomyopathy
Keywords: 123I-mIBG
AdreView
SPECT
Heart to Mediastinal Ratio
Lead sponsor: Aspire Foundation
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2013-06-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to demonstrate correlation of the H/M ratio of AdreView when derived from a large field of view Anger SPECT system and from a small field of view high sensitivity (CZT) SPECT system.


Eligibility criteria: Inclusion Criteria:

* New York Heart Association Class II or III Heart Failure
* Left ventricular ejection fraction less than or equal to 35%

Exclusion Criteria:

* Uncompensated heart failure
* Recent hospitalization within 30 days of cardiac related indications

Primary outcomes:
measure: Relationship of H/M ratios obtained on LFOV and SFOV-HE systems
timeFrame: 3 months post-enrollment close
Secondary outcomes:
measure: Image Quality
timeFrame: 3 month post-enrollment close
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Cardiovascular Imaging Technologies
state: Missouri
Study officials:
affiliation: Aspire Foundation
name: Timothy M Bateman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213941: Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates
Official title: Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transient Tachypnoea of the Newborn
Keywords: transient tachypnoea of the newborn
surfactant deficiency
persistant pulmonary hypertension of the neonate
lung maturity tests
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Transient tachypnoea of the newborn (TTN) is a common cause of hospitalisation in the neonatal period, complicating 1 to 1,5 per cent life birth. Predisposing factors are prematurity, birth after C section, especially before the onset of labor. The main factor leading to this condition is a lack of absorption of the fluid contained in the alveolar space resulting in an early respiratory distress which normally resolves in two to five days with oxygen supplementation.

Meanwhile, some neonates will experience a complicated evolution requiring ventilatory support and hospitalisatioon in neonatal intensive care unit. This complication is not preventable and could result either of a surfactant deficiency (primary or secondary) or a persistent pulmonary hypertension of the neonate (PPHN).

In this study, a cohort of newborn presenting TTN will be followed, in order to evaluate, at initial admission, pulmonary maturation (with fetal lung maturity test and the stable microbubble test) and to seek for PPHN (echochardiography). Therapeutic management will be done according to standard care and classification of the neonate will be performed according to their clinical evolution: group 1 (uncomplicated TTN) and group 2 (complicated TTN).

Statistical analysis will compare results of the tests at initial evaluation in the two groups, and accuracy of the tests to predict a complicated evolution will be established.


Eligibility criteria: Inclusion Criteria:

* Neonate \> or = 34 weeks GA admitted in the first 6 hours of life with the suspected diagnosis of TTN (respiratory rate \> 60/mn, SpO2 \< 90% in room air, ilvermann score \> 0
* Parental consent obtained

Exclusion Criteria:

* GA\> 42 weeks
* meconial amniotic fluid
* early onset neonatal sepsis (septic shock)
* congenital malformations
* enteral feeding started before admission
* no parental consent

Primary outcomes:
measure: Evaluate and compare the accuracy of different tests at initial evaluation in predicting a complicated course in neonae with TTN
Secondary outcomes:
measure: Increase the knowledge in the physiopathology of TTN
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pédiatrie 2, Hôpital de Hautepierre
Study officials:
affiliation: Service de Pédiatrie, Hôpital de Hautepierre
name: Pierre KUHN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01569841: A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes
Official title: A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-04-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy of insulin decludec with insulin glargine on glycaemic control using continuous glucose monitoring in patients with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* HbA1c (glycosylated haemoglobin) below or equal to 8.5%
* Current treatment with IGlar (insulin glargine) in a basal-bolus regimen with a total daily dose below 120 U
* BMI (body mass index) below 35 kg/m\^2

Exclusion Criteria:

* Use within the last 3 months prior to visit 1 (screening) of any antidiabetic glucose lowering drug other than insulin/insulin analogues
* Subjects with regular use of acetaminophen who are not willing to use another analgetic during CGM (Continuous Glucose Monitoring) periods
* Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty within 24 weeks prior to visit 1
* Recurrent severe hypoglycemia (more than one severe hypoglycemic event during the last 12 months) or hypoglycemia unawareness or hospitalization for diabetic ketoacidosis during the previous 6 months

Primary outcomes:
measure: Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)
timeFrame: CGM occured during the last 2 weeks of the 6 weeks treatment period.
Secondary outcomes:
measure: Mean Interstitial Glucose (IG) Based on 14 Days of CGM
timeFrame: CGM monitoring occurred during the last 2 weeks of the 6-week treatment period.
measure: Fasting Plasma Glucose (FPG)
timeFrame: At the end of each 6 week treatment period.
measure: Glycosylated Haemoglobin (HbA1c)
timeFrame: At the end of each 6 week treatment period.
measure: Number of Treatment Emergent Adverse Events (AEs)
timeFrame: Within each week 6 treatment period
measure: Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
timeFrame: Hypoglycemic episodes reported within each 6 week treatment period.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Minnesota
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05770141: Laser Hemorrhoidoplasty Versus Open Surgical Hemorrhoidectomy in Second and Third Degree Piles
Official title: Laser Hemorrhoidoplasty Procedure Versus Open Surgical Hemorrhoidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhoids
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to compare the pain , duration of intervention and long term outcomes of laser hemorrhoidoplasty versus open surgical hemorrhoidectomy

Detailed description: Hemorrhoidal disease is ranked first among diseases of the rectum and large intestine, and the estimated worldwide prevalence ranges from 2.9% to 27.9%, of which more than 4% are symptomatic .

Age distribution demonstrates a Gaussian distribution with a peak incidence between 45 and 65 years with subsequent decline after 65 years .Men are more frequently affected than women .

The anorectal vascular cushions along with the internal anal sphincter are essential in the maintenance of continence by providing soft tissue support and keeping the anal canal closed tightly. Hemorrhoids are considered to be due to the downward displacement of suspensory (Treitz) muscle .

There are many treatments of hemorrhoids varying from medications and band ligation to stapled hemorrhoidopexy, laser photocoagulation, sclerotherapy, Doppler-guided artery ligation, and finally surgery .

The indications for the surgical treatment include the presence of a significant external component, hypertrophied papillae, associated fissure, extensive thrombosis or recurrence of symptoms after repeated RBL. The technique employed may be open (Milligan-Morgan) or closed (Ferguson) .

Post hemorrhoidectomy pain is the commonest problem associated with the surgical techniques. The other early complications are urinary retention (20.1%), bleeding (secondary or reactionary) (2.4%-6%) and subcutaneous abscess (0.5%). The long-term complications include anal fissure (1% -2.6%), anal stenosis (1%), incontinence (0.4%), fistula (0.5%) and recurrence of hemorrhoids .

The study aims to compare the pain , duration time of intervention and long term outcomes of laser hemorrhoidoplasty versus open surgical hemorrhoidectomy

Eligibility criteria: Inclusion Criteria:

* II-III hemorrhoidal disease
* failure of conservative treatment

Exclusion Criteria:

* grade IV
* acutely thrombosed haemorrhoids
* patients affected by IBD involving rectum or anus
* patients previously surgically treated for hemorrhoidal disease and the inability to complete study protocol

Primary outcomes:
measure: Pain evaluation
timeFrame: 30 postoperative days
measure: bleeding
timeFrame: 30 postoperative days
Secondary outcomes:
measure: Presence of recurrence
timeFrame: 6 months
Other outcomes:
measure: anal stenosis
timeFrame: 6 months
Locations:
Study officials:
References:
Clinical trial NCT04970641: Three Good Things (3GT) - Intervention for Transitional Care Patients
Official title: Three Good Things (3GT) - Intervention for Transitional Care Patients at the Mayo Clinic Bloomer Critical Access Hospital
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Positive Thinking
Psychology, Positive
Resilience, Psychological
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 25
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: Researchers are doing this research study to learn how the Three Good Things (3GT) Positive Psychology journaling activity affects symptoms of stress, depression, resilience, and happiness.

Detailed description: The purpose of this study is to measure, rank and categorize the subject sample of depression, stress, resilience and happiness scores using quantitative surveys. This research aims to learn how a Three Good Things (3GT) journaling activity affects a subject's symptoms of stress, depression, resilience and happiness. The data will allow the project team to gain an in-depth understanding of the impact of the use of resilience strategies from a hospitalized patient's perspective. The project aims to review if there is a correlation between stress, depression, resiliency, and happiness scores to the use of Positive Psychology.

Eligibility criteria: Inclusion Criteria:

* Individuals ≥ 18 years of age.
* Current inpatient at the Mayo Clinic Health System Bloomer Hospital, Bloomer, Wisconsin (a Swing Bed Hospital as defined by the Center for Medicare and Medicaid Services (CMS)).
* Able to speak English.
* Able to answer questionnaires.

Exclusion Criteria:

* Individuals \< 18 years of age.
* Patient unwilling or unable to provide consent to participate in this research study.
* Patient under guardianship.
* As determined through self-report, patient in active psychosis, active suicidal ideation, active substance abuse meeting criteria for substance use disorders except for nicotine (the exception is patients with a history of substance abuse that have been in remission for at least one full year).
* Patient diagnosed with obsessive-compulsive disorder, active panic disorder with agoraphobia or other phobic disorder, active Post Traumatic Stress Disorder, or active severe personality disorders.
* Patient with previous participation in this study.

Primary outcomes:
measure: Perceived Stress
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Subjective Depression
timeFrame: Baseline, 6 weeks
measure: Subjective Happiness
timeFrame: Baseline, 6 weeks
measure: Subjective Resilience
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Bloomer
country: United States
facility: Mayo Clinic Health System Bloomer Hospital
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Lori M Miller, MAOM, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02202941: Procalcitonin-guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients
Official title: Effect of Procalcitonin-guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Evidence-based healthcare Collaborating Agency (NECA)
name: Asan Medical Center
name: Samsung Medical Center
name: Severance Hospital
First posted: 2014-07-29
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is aimed to show a procalcitonin-guided treatment algorithm may shorten duration of antibiotic therapy safely and cost-effectively in sepsis patients of Korean ICU.


Eligibility criteria: Inclusion Criteria:

* All patients with suspicious or confirmed sepsis at admission or during stay in ICU
* Patients with antibiotic duration of less than 48 hours before enrollment

Exclusion Criteria:

* Age less than or equal to 18 years
* Known pregnancy
* Specific infections for which long-term antibiotic treatment for 3 weeks more is strongly recommended: infective endocarditis, empyema, osteomyelitis et al.
* severe immunocompromised patients : HIV infected patients (CD4 count \< 200 cells/mm3), Neutropenia (ANC count \< 500/mm3)
* Presence of do-not-resuscitate order

Primary outcomes:
measure: Duration of antibiotic treatment
timeFrame: up to 28 days
Secondary outcomes:
measure: Clinical response to treatment for infection
timeFrame: up to 28 days
measure: In ICU mortality
timeFrame: up to 28 days
measure: All cause mortality
timeFrame: up to 28 days
measure: In hospital mortality
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sang-Min Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeon K, Suh JK, Jang EJ, Cho S, Ryu HG, Na S, Hong SB, Lee HJ, Kim JY, Lee SM. Procalcitonin-Guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients (PRODA): a Multi-Center Randomized Controlled Trial. J Korean Med Sci. 2019 Apr 15;34(14):e110. doi: 10.3346/jkms.2019.34.e110.