louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04658212: A Multicenter Randomized Controlled Study of 3D Laparoscopy Versus Endoscopy in the Treatment of Choledocholithiasis
Official title: A Multicenter Randomized Controlled Study of 3D Laparoscopy Versus Endoscopy in the Treatment of Choledocholithiasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Choledocholithiasis
ERCP
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The incidence of choledocholithiasis is gradually rising with the increase of gallstone incidence. The popular minimally invasive treatment options include endoscopic retrograde cholangiopancreatography (ERCP) and laparoscopic common bile duct exploration (LCBDE). Currently, three-dimensional (3D) video system for laparoscopy is developed to ofer surgeon a superior depth perception and a much better user experience, thus potential increasing operation accuracy and stability. It have suggested that compared with 2D laparoscopy, 3D laparoscopy can effectively reduce operation time and numbers of errors. However, rare experimental studies are performed to evaluate the safety and effectiveness of 3D laparoscopy in choledocholithiasis patients. The aim of this study is to compare the perioperative outcomes between 3D laparoscopy and ERCP in choledocholithiasis patients through a multicenter randomized controlled design.


Eligibility criteria: Inclusion Criteria:

1. The diagnosis of choledocholithiasis based on preoperative image studies including abdominal ultrasonography, computed tomography (CT), and/or magnetic resonance cholangiopancreatography (MRCP) with relevant supporting laboratory examinations
2. Age \<80y and \>18y
3. Non-emergency surgery

Exclusion Criteria:

1. Diagnosis of Mirizzi's syndrome,
2. Acute suppurative cholangitis
3. Detection of bilioenteric anastomosis
4. Pathological diagnosis of cholangiocarcinoma
5. Extended surgery due to multiple biliary strictures,
6. Intrahepatic stones

Primary outcomes:
measure: Perioperative Complication Rate
timeFrame: 1 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02635412: Delivery Timing in Morbidly Adherent Placentas: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Morbidly Adherent Placenta
Placenta Accreta
Keywords: Placenta
Accreta
Morbidly
Adherent Placenta
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2015-12-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomized controlled trial to investigate the optimal timing of delivery in clinically stable women with a suspected morbidly adherent placenta.

Detailed description: This is a randomized controlled trial to investigate the optimal timing of delivery in clinically stable women with a suspected morbidly adherent placenta dispositioned for a scheduled delivery. The primary outcome will be assessed by comparing the composite neonatal morbidity and composite maternal morbidity between the two groups (delivery at 34 versus 36 weeks gestational age).

Eligibility criteria: Inclusion Criteria:

* Women with monographically morbidly adherent placenta with or without a placenta previa.
* Scheduled delivery via cesarean hysterectomy

Exclusion Criteria:

* Delivery planned prior to 36 weeks (e.g. non-reassuring fetal status, preterm labor, severe preeclampsia, other medical/fetal indication for delivery as determined by the managing physician).

Primary outcomes:
measure: Composite neonatal morbidity
timeFrame: Within 72 hours of newborn discharge
measure: Maternal neonatal morbidity
timeFrame: Within 72 hours of patient discharge
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04515212: In-Field Detection of Intracranial Pressure
Official title: In-Field Detection of Acute Intracranial Hemorrhage Requiring Urgent, Life-Saving Treatment in Severe Traumatic Brain Injury (TBI) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2020-08-17
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This is a research study to develop a noninvasive test using ultrasound to determine when urgent, life-saving treatment is needed for those with severe traumatic brain injuries.


Eligibility criteria: Healthy Volunteer Inclusion Criteria:

* Adults 18 or older
* Able to provide legally effective consent

Healthy Volunteer Exclusion Criteria:

* Intracranial disease, neurologic symptoms, or eye pathology

Patient Inclusion Criteria:

* Adults age 18 or older
* Confirmed or suspected severe traumatic brain injury
* Able to provide legally effective consent

Patient Exclusion Criteria:

* Significant bilateral ocular trauma

Primary outcomes:
measure: Optic nerve sheath diameter
timeFrame: Approximately 10 minutes at the time of ultrasounds
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Sean Montgomery
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00828412: Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis
Official title: A Randomized, Investigator-Blind, Six-Week, Parallel Group, Multicenter Pilot Study to Compare the Safety and Efficacy of EpiCeram Skin Barrier Emulsion and Desonide Cream 0.05% in the Twice Daily Treatment of Pediatric Subjects With Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Lead sponsor: Promius Pharma, LLC
Sponsor class: INDUSTRY
First posted: 2009-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear.


Eligibility criteria: Inclusion Criteria:

* at least 3 months of age and less than 13 years of age
* atopic dermatitis of moderate severity

Exclusion Criteria:

* pregnant or lactating
* treatment of atopic dermatitis with topical product in the 14 days prior to Baseline
* treatment of atopic dermatitis with systemic product in the 30 days prior to Baseline
* serious or uncontrolled medical condition
* active infection
* significant use of inhaled, intranasal, or intraocular corticosteroid

Primary outcomes:
measure: Change From Baseline in Three Item Severity Score
timeFrame: Baseline to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Winston Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: Dermatology Research Associates
state: Ohio
city: Houston
country: United States
facility: University of Texas
state: Texas
Study officials:
affiliation: Promius Pharma, LLC
name: Joanne Fraser, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03428581: Preventing Lymphedema in Axillary Lymph Node Dissection
Official title: Preventing Lymphedema in Patients Undergoing Axillary Lymph Node Dissection Via Axillary Reverse Mapping and Lympho-venous Bypass
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lymphedema
Breast Cancer
Melanoma
Keywords: Axillary
Lymph node
Dissection
Reverse Mapping
Lympho-venous Bypass (LVB)
Axillary Reverse Mapping (ARM)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 264
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-operative lymphedema of the arm.

Detailed description: All subjects will undergo an axillary lymph node dissection (ALND). Cluster randomization will determine which of these subjects will have the ARM with LVB and which subjects will have the ALND without this technique. As a baseline, all subjects will have the circumference of their arms measured and complete a questionnaire about lymphedema. Performing the measurements and answering a questionnaire will be repeated at 6, 12, 24, and 36 months after surgery.

Eligibility criteria: Inclusion Criteria

* Patients scheduled to undergo an axillary lymph node dissection
* Patients who in the surgeon's judgement are at high risk to convert to an axillary lymph node dissection based intraoperative findings
* English speaking

Exclusion Criteria

* Prior ipsilateral axillary lymph node dissection
* Prior ipsilateral axillary radiation
* Patients undergoing sentinel lymph node biopsy only or at low risk of converting to an axillary lymph node dissection in the surgeon's judgement
* Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema.
* Pregnant patients cannot participate in the substudy

Primary outcomes:
measure: Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity
timeFrame: 36 months following surgery
measure: Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity
timeFrame: 36 months following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: James W Jakub, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic in Rochester
name: Mara A. Piltin, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00560781: Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs
Official title: Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: PTSD
Pregnenolone
Cognition
Lead sponsor: Durham VA Medical Center
Sponsor class: FED
First posted: 2007-11-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the therapeutic potential of augmenting a stable SSRI regimen with the neurosteroid pregnenolone to reduce cognitive symptoms and PTSD symptoms in patients diagnosed with PTSD.

Detailed description: See brief summary

Eligibility criteria: Inclusion Criteria:

1. 18-65 years of age, any ethnic group, either sex
2. DSM-IV diagnosis of PTSD by MINI (see schedule of events)
3. No change in SSRI medications for \> 4 weeks.
4. No anticipated need to alter any psychotropic medications for the 10-week duration of the study.
5. Ability to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process.

Exclusion Criteria:

1. Unstable medical or neurological illness, including seizures, CVA, prostate or breast cancer
2. Use of oral contraceptives or other hormonal supplementation such as estrogen.
3. Significant suicidal or homicidal ideation.
4. Concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary.
5. Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition; history of substance dependence within the last 3 months
6. Female patients who are pregnant or breast-feeding.
7. Known allergy to study medication.
8. Drugs with a narrow therapeutic index (e.g. thioridazine, mesoridazine, ziprasidone, clozapine, etc.) will be excluded, as suggested by the FDA; patients taking these agents will not be eligible for this study.

Primary outcomes:
measure: CAPS, BAC-A
timeFrame: Prospective
Secondary outcomes:
measure: PCL, CD-RISC, CGI, BDI-II
timeFrame: Prospective
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VAMC
state: North Carolina
Study officials:
affiliation: Durham VAMC
name: Christine E Marx, MD MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00625781: Treatment of Impaired Glucose Tolerance in Pregnancy
Official title: Randomized Controlled, Multicenter Study Evaluating Treatment of Glucose Intolerance in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Glucose Tolerance
Fetal Macrosomia
Keywords: Gestational diabetes mellitus
Impaired glucose Tolerance
Pregnancy
Fetal macrosomia
Treatment
Perinatal morbidity
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Uppsala-Örebro Regional Research Council
First posted: 2008-02-28
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate if treatment (insulin or diet) of pregnant women with impaired glucose tolerance (75-g OGTT with a fasting P-gluc \<7.0 mmol/l and 2 h P-gluc \>10.0 and \<12.2 mmol/l) close to normoglycemia reduces children´s birth weight and neonatal morbidity. There will be a focus on treatment according to specific goals and separate follow-up regimes for the children and women post partum.


Eligibility criteria: Inclusion Criteria:

* Women with 75g OGTT result : fasting capillary plasma \<=7.0 mmol/l and/or 2 h value \>= 12.2 mmol/l

Exclusion Criteria:

* Multiple pregnancy
* Pregestational Diabetes

Primary outcomes:
measure: Perinatal morbidity and intrauterine growth
timeFrame: 1 year post partum
Secondary outcomes:
measure: Children´s future health
timeFrame: 5 years
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: University Hospital Örebro
Study officials:
affiliation: Uppsala Academic Hospital , Sweden
name: Ulf Hanson, Consultant
role: STUDY_CHAIR
affiliation: Region Örebro County
name: Ingrid Östlund, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06941181: Neurocognitive Predictors of Health Risk Behaviors
Official title: Neurocognitive Predictors of Health Risk Behaviors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance Use
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study proposes to extend the ongoing longitudinal study of health risk behaviors and obtain new data from former adolescents (followed previously from ages 13-22; Times 1-8) now from ages 23 to 28 (Times 9-11). The goal of this study is to examine the contribution of developing neurocognitive markers to substance use in young adulthood by following a well-characterized longitudinal sample.

Detailed description: The main questions it aims to answer is: what are the long-term effects of valuation and control decision-making systems on health risk behaviors? Participants will complete online surveys assessing their substance use behaviors and perform neurocognitive tasks related to risk processing and cognitive control across three time points.

Eligibility criteria: Inclusion Criteria:

- Adolescents (now young adults) who participated in the original longitudinal project.

Exclusion Criteria:

* standard contraindications for magnetic resonance imaging at the study onset
* history of seizures/stroke
* a head injury with \> 10 min of unconsciousness or neurological sequelae

Primary outcomes:
measure: substance use behaviors
timeFrame: Approximately every 18 months, 3 times across 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: Virginia Tech
state: Virginia
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute at VTC
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Jungmeen Kim-Spoon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Polytechnic Institute and State University
name: Brooks Casas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00803881: Longitudinal Pathogen-colonization in Cystic Fibrosis Airways and Ability to Smell
Official title: Prevalence of Chronic Rhinosinusitis, Pathogen-colonization in the Upper and Lower Airways and Ability to Smell in Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis With Other Manifestations
Sinusitis
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2008-12-08
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of the CF outpatients clinic and hospitalized CF patients

Brief summary: Aim of the study is to detect the prevalence of chronic rhinosinusitis, pathogen colonization of the lower and upper airways and, in a sub-cohort the sense of smelling in patients with cystic fibrosis.

Detailed description: The sub-study on the sense of smelling in CF has been finalized in the meantime. Results were published in 2012:

Smell in cystic fibrosis. Lindig J, Steger C, Beiersdorf N, Michl R, Beck JF, Hummel T, Mainz JG. Eur Arch Otorhinolaryngol. 2013 Mar;270(3):915-21. doi: 10.1007/s00405-012-2124-2. Epub 2012 Aug 14.

Eligibility criteria: Inclusion Criteria:

* Subject has a confirmed diagnosis of cystic fibrosis

Primary outcomes:
measure: Dynamics in CF upper and lower airway colonization with pathogens
timeFrame: 10 years
measure: Assessment of ability to smell in CF patients
timeFrame: 3 years
Secondary outcomes:
measure: pulmonary function / BMI
timeFrame: 10 years
Other outcomes:
Locations:
city: Jena
country: Germany
facility: University of Jena - CF-Center
Study officials:
affiliation: University of Jena - CF Center
name: Jochen Mainz, MD
role: STUDY_CHAIR
References:
citation: Lindig J, Steger C, Beiersdorf N, Michl R, Beck JF, Hummel T, Mainz JG. Smell in cystic fibrosis. Eur Arch Otorhinolaryngol. 2013 Mar;270(3):915-21. doi: 10.1007/s00405-012-2124-2. Epub 2012 Aug 14.
citation: Mainz JG, Michl R, Pfister W, Beck JF. Cystic fibrosis upper airways primary colonization with Pseudomonas aeruginosa: eradicated by sinonasal antibiotic inhalation. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1089-90. doi: 10.1164/ajrccm.184.9.1089. No abstract available.
citation: Mainz JG, Hentschel J, Schien C, Cramer N, Pfister W, Beck JF, Tummler B. Sinonasal persistence of Pseudomonas aeruginosa after lung transplantation. J Cyst Fibros. 2012 Mar;11(2):158-61. doi: 10.1016/j.jcf.2011.10.009. Epub 2011 Nov 30.
citation: Mainz JG, Naehrlich L, Schien M, Kading M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tummler B. Concordant genotype of upper and lower airways P aeruginosa and S aureus isolates in cystic fibrosis. Thorax. 2009 Jun;64(6):535-40. doi: 10.1136/thx.2008.104711. Epub 2009 Mar 11.
Clinical trial NCT03366181: SGLT2i As Anti Arrhythmic Therapy to Prevent Sudden Cardiac Deaths.
Official title: SGLT2i As Anti Arrhythmic Therapies and Sudden Cardiac Death in Implantable Cardioverter Defibrillators (ICDs) Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
ICD
Diabetes Mellitus Type 2
SGLT2i
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: heart failure patients with reduced LVEF (LVEF \<35%) and affected by T2DM, previously treated with ICD and indication to receive SGLT2i therapy.

Brief summary: Failing heart negative remodeling alterations might provide electrical heterogeneity and cardiac remodeling, thus potentially contributing to the occurrence of ventricular arrhythmia and subsequent sudden cardiac death (SCD). In this study we have prospectively investigated whether sodium glucose transporte-2 inhibitors (SGLT2i) could modulate serum markers of heart failure (ultra sensitive Troponin , B type Natriuretic Peptide (BNP), C reactive protein (CRP), the heart rate (HR) and serum catecholamines in patients with type 2 diabetes mellitus (T2DM), and be used as predictors for the occurrence of malignant ventricular arrhythmias (VTAs) in patients who had received an Implantable Cardioverter Defibrillator (ICD) for primary prevention. In these T2DM patients with ICD we investigated the functionality of devices, the appropriate and inappropriate shocks, and the hospitalizations for heart failure and the cardiac deaths.


Eligibility criteria: Inclusion Criteria:

* stable heart failure; indication for a ICD and/or a CRT-d system; NYHA Class II-III; left ventricle ejection fraction \<35%; patients receiving optimal medical therapy without controindications to receive SGLT2i; diagnosis of T2DM.

Exclusion Criteria:

* NYHA Class I, and IV; co-morbidities which may limit life to \<6 months; history of cardiac surgery or intervention within the preceding 90 days; history of moderate to severe chronic obstructive pulmonary disease (COPD), defined as needing chronic oxygen therapy, or recent (within 30 days) hospitalization for COPD flare-up; pregnancy; history of primary pulmonary hypertension.

Primary outcomes:
measure: cardiac deaths
timeFrame: 12 months
measure: Heart failure hospitalization
timeFrame: 12 months
measure: ICDs' intervention
timeFrame: 12 months
Secondary outcomes:
measure: arrhythmic burden
timeFrame: 12 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Raffaele Marfella
Study officials:
References: