louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01880450: Project Prepared: Risks, Roles and Relationships
Official title: Longitudinal Intervention Study to Prepare Early Adolescents for Middle Adolescence, Specifically Focusing on Improving Sexual Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: F01.145.802.845
F01.145.802.987
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-06-19
Enrollment: 397
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Project Prepared is a theoretically based, comprehensive, intensive group intervention that is designed to prepare early adolescents for middle adolescence and its challenges. It emphasizes skills in avoiding risky sexual situations, and provides medically accurate information about sexual development, sexually transmitted infections and pregnancy. Effectiveness is measured by using a randomized control trial design and tracking differences in cognitive factors (HIV/STI (Sexually Transmitted Infections) knowledge, sexual self-efficacy; intention to use a condom); relationship factors (immature romantic beliefs, relationship self-efficacy), gender norms (macho man, powerless female), and resilience.


Eligibility criteria: Inclusion Criteria:

* 12-14 yrs old
* lives in the Bronx, NY at Baseline
* Has been seen at some point in one of the Montefiore Medical Center community health clinics.

Exclusion Criteria:

* Inability to independently complete the questionnaire/training due to sensory, cognitive or motor disabilities.
* Reading ability NOT at 5th grade on the reading subtest of the Wide-range Achievement Test.

Primary outcomes:
measure: Change in Intentions to engage in safer sex behavior at 6 months
timeFrame: 6 months post baseline
measure: Change in Intentions to engage in safer sex behavior at 1 year
timeFrame: 1 year post baseline
Secondary outcomes:
measure: Change in Cognitive Factors at 6 months
timeFrame: 6 months post baseline
measure: Change in Cognitive Factors at 1 year
timeFrame: 1 year post baseline
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine, Pediatrics Division
name: Laurie J Bauman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bauman LJ, Watnick D, Silver EJ, Rivera A, Sclafane JH, Rodgers CRR, Leu CS. Reducing HIV/STI Risk Among Adolescents Aged 12 to 14 Years: a Randomized Controlled Trial of Project Prepared. Prev Sci. 2021 Nov;22(8):1023-1035. doi: 10.1007/s11121-021-01203-0. Epub 2021 Feb 19.
Clinical trial NCT05140850: Long-term Consequences of Neuroimaging and Perceived Cognitive Dysfunction in oPRES
Official title: Long-term Consequences of Neuroimaging and Perceived Cognitive Dysfunction in Obstetrics Posterior Reversible Encephalopathy Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuroimaging
Cognitive Dysfunction
Posterior Reversible Encephalopathy Syndrome
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 500
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We divided the PE or E patients into two groups, namely PRES group and non-PRES group, according to diagnostic criteria . the general information（demographic data，blood pressure.etc.）and blood sample will be collected.

Brief summary: The purpose of this study is to explore the long-term consequences of neuroimaging and perceived cognitive dysfunction in obstetrics posterior reversible encephalopathy syndrome.

Detailed description: This is a prospective study. The investigators divided the PE or E patients into two groups, namely PRES group and non-PRES group, according to diagnostic criteria . The general information（demographic data，blood pressure.etc.）and blood sample will be collected. Additionally,all patients receive neuroimaging examination（DTI,ASL,3D-TMI.etc.）and neuro-cognitive test（MMSE,MOCA,CFQ, etc.） to assess the cerebral white matter lesions and cognitive changes.

Eligibility criteria: Inclusion Criteria:

1. patients were diagnosed of PE or E
2. patients received cranial image examination
3. patients consent to participate

Exclusion Criteria:

1. patients combined other neurological diseases
2. patients combined mental illness

Primary outcomes:
measure: neuroimaging examination
timeFrame: within 10 years after deliver
measure: neuro-cognitive test of Mini-mental State Examination
timeFrame: within 10 years after deliver
measure: neuro-cognitive test of Montreal Cognitive Assessment
timeFrame: within 10 years after deliver
measure: blood pressure and hypertension
timeFrame: within 10 years after deliver
measure: level of lactate dehydrogenase(LDH)
timeFrame: within 10 years after deliver
measure: level of LDL in blood
timeFrame: within 10 years after deliver
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University
Study officials:
References:
Clinical trial NCT04728750: Laparoscopic Enucleation of Frantz's Tumor of the Pancreas
Official title: Laparoscopic Enucleation of Frantz's Tumor of the Pancreas: Case Report and Literature Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Pseudopapillary Neoplasm of the Pancreas
Lead sponsor: Tecnologico de Monterrey
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosed pancreatic tumor by image study.

Brief summary: The present study describes a 32-year-old female patient, in whom a preoperative imaging diagnosis confirmed a mass in the junction of the body and tail of the pancreas. Based on the anamnesis, on the preoperative diagnosis, and on the general status of the patient, the decision was made to performed laparoscopic enucleation of the pancreatic tumor. The operation and postoperative recovery passed without complications. A minimally invasive surgical approach should be applied whenever the dimensions and the localization of the tumor permits it, bearing in mind all the benefits and advantages that this surgical technique has to offer.


Eligibility criteria: Inclusion Criteria:

* Patients with benign tumor of the pancreas
* Patients with a size tumor of less than 3 cm on the pancreas

Exclusion Criteria:

* Patients with a size tumor greater than 3 cm on the pancreas
* Malignant tumors of the pancreas

Primary outcomes:
measure: Complete enucleation of a tumor in the pancreas
timeFrame: December 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Escuela Nacional de Medicina, Tecnologico de Monterrey
state: Nuevo Leon
Study officials:
References:
Clinical trial NCT03172650: Effect of Non-alcoholic Fatty Liver Disease on Kidney Functions
Official title: Effect of Non-alcoholic Fatty Liver Disease on Kidney Functions: Observational Case Control Study in Upper Egypt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited outpatient clinic of internal medicine of Luxor international hospital and Assiut university hospital

Brief summary: Non-alcoholic fatty liver disease is the most common cause of chronic liver disease worldwide. It is defined as the accumulation of fat (\>5%) in the liver cells in the absence of excessive alcohol intake or other causes of liver disease including viral, drug-induced, or autoimmune. Non-alcoholic fatty liver disease is a hepatic manifestation of metabolic syndrome.


Eligibility criteria: Inclusion criteria:

* All non alcoholic fatty liver disease patients evidenced by abdominal ultrasound.
* Urine analysis whether normal or renal sedimentation.

Exclusion criteria:

1. Alcoholic fatty liver patients.
2. patients known to have diabetes mellitus.
3. patients with other causes of liver disease as viral hepatitis, drug induced,or autoimmune.
4. patients known to have kidney disease.
5. Hypertension.
6. Hyperuricemia.
7. Impaired urea and creatinine patients.

Primary outcomes:
measure: The percentage of patients with abnormal laboratory glomerular filtration rate
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT03216850: Evaluation of Lipid Emulsion on GCX in Critically Ill Patients
Official title: Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection. Effect of Parenteral Nutrition and Plasma Lipidome on GCX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endothelial Dysfunction
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who meet the inclusion criteria admitted to the ICU.

Brief summary: Characterisation of the lipidome and parenteral nutrition modulate the endothelial glycocalyx.

The aim of the study A is to detect any influence of the lipid emulsion on the endothelial glycocalyx in patients in critical care. The targeted cohort is patients on ICU with an indication for parenteral nutrition including lipid emulsion. 15 patients are planned to be enrolled.

Monitored variables: demographic data, type of the population, type of the lipid emulsion, selected variables of the lipid metabolism, sublingual microcirculation (SDF imaging),


Eligibility criteria: Inclusion Criteria:

* patients in ICU
* indication for lipid administration as a part of TPN

Exclusion Criteria:

* shock or clinical/laboratory signs of tissue hypoperfusion
* previous lipid infusions (within 3 months before entering study)
* hyperlipidaemia
* hyperglycaemia (over 10 mmol/l)
* current or previous (within 72 hours before entering the study) use of propofol
* pancreatitis
* severe liver failure
* current use of statins

Primary outcomes:
measure: Endothelial Glycocalyx Thickness
timeFrame: One week within the ICU care
Secondary outcomes:
Other outcomes:
Locations:
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Kralove
state: Třebeš
Study officials:
affiliation: University Hospital Hradec Kralove
name: Vladimir Cerny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02886650: Impact of Thermocoagulation During Invasive EEG Monitoring in Children With Focal Drug-resistant Epilepsies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Keywords: Paediatrics
epilepsy surgery
genetic mutation
focal seizures
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: When focal epilepsies become drug-resistant, it could be eligible for cortical surgical resection. Therefore, an invasive EEG monitoring with depth electrodes is often needed during presurgical evaluation. Some of these children can have access to thermocoagulation inside the ictal onset zone, at the end of the monitoring and before to remove the electrodes. These thermocoagulations can disorganize the epileptogenic network thanks to millimetric cortical lesions around the electrodes. The aim is to stop or at least, to reduce the seizure frequency for few weeks or months. This could be a benefit for the child, and also a confirmation of the ictal onset zone and guide the surgeon. This technique is currently used in adult population for years, but remains very rare in children.


Eligibility criteria: Inclusion Criteria:

* age 18 month to 17 years old
* focal drug-resistant epilepsy
* small size lesion (1 or 2 gyri) or cryptogenic epilepsy
* indication for EEG monitoring with depth electrodes during presurgical evaluation

Exclusion Criteria:

* formal contraindication to surgery or anaesthesia
* functional area or potentially large epileptic area
* refusal to participate in the study
* no health insurance coverage

Primary outcomes:
measure: Number of children with a decrease of at least 50% of the seizure frequency
timeFrame: one month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Mathilde CHIPAUX, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00637650: Management of Fragments During Ureteroscopy
Official title: Should we Strive for Absolute "Stone Freedom" While Performing Holmium Laser Lithotripsy for Ureteral Stones? A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Stones
Lead sponsor: The Chaim Sheba Medical Center
Sponsor class: OTHER
First posted: 2008-03-18
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to study the outcome of patients after ureteroscopy in which all fragments remaining after holmium laser lithotripsy were retrieved compared to those where small, insignificant fragments were left for spontaneous passage.


Eligibility criteria: Inclusion Criteria:

* Patient with ureteral stones suitable for endoscopic treatment

Exclusion Criteria:

* presence of ipsilateral kidney stones
* known ureteral stricture
* previous placement of ureteral stent
* use of drugs with known activity on smooth ureteral muscle
* unwillingness or impossibility to return for follow-up

Primary outcomes:
measure: unplanned medical visits
timeFrame: 30 days
Secondary outcomes:
measure: Hospital Admissions, need for pain killers, time to complete recovery
timeFrame: 60 days
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
state: Ramat Gan
Study officials:
References:
Clinical trial NCT01919450: Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation
Official title: Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Blood Flow Reserve
Keywords: PET
Lexiscan
Regadenoson
Rubidium
Blood Flow Reserve
Myocardial Perfusion
Quantitated Myocardial Perfusion
Lead sponsor: Cardiovascular Imaging Technologies
Sponsor class: INDUSTRY
First posted: 2013-08-09
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
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 evaluate the consistency of quantitative peak stress myocardial blood flow and myocardial blood flow reserve following a 10 second, 1 minute, 2 minute or 4 minute delay in beginning the rubidium-82 infusion post-Lexiscan (regadenoson) injection. It is anticipated that there will be no or minimal difference between the four delay times.


Eligibility criteria: Inclusion Criteria:

* Recent normal clinically-indicated exercise myocardial perfusion SPECT, treadmill maximal exercise test or exercise echocardiographic study
* No change in symptoms between the exercise study and PET study
* Capable of providing written informed consent
* BMI 25-32 kg/m2

Exclusion Criteria:

* Diabetes mellitus
* Coronary Artery Calcium Score \>25
* Second and Third Degree Atrioventricular Node Block
* Sinus Node Dysfunction
* Recent Syncope of unknown etiology
* Left ventricular hypertrophy per ECG or echocardiography
* Slowed circulation times
* Active wheezing or with acute asthmatic or bronchospastic attacks requiring changes in therapy within the past 30 days.
* Patients that have experienced a previous hypersensitivity reaction thought to be related to Lexiscan

Primary outcomes:
measure: Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson)
timeFrame: 4 minutes
measure: Measure Quantitated Myocardial Perfusion Reserve After a 2 Minute Delay in Lexiscan (Regadenoson)
timeFrame: 2 mintues
measure: Measure Quantitated Myocardial Perfusion Reserve After a 10 Second Delay in Lexiscan (Regadenoson)
timeFrame: 10 seconds
measure: Measure Quantitated Myocardial Perfusion Reserve After a 1 Minute Delay in Lexiscan (Regadenoson)
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Hospital Imaging Center
state: Missouri
Study officials:
affiliation: Cardiovascular Imaging Technologies
name: Timothy M Bateman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03224650: Validation of Novel Predictive Score for Patients With Spinal Metastases
Official title: Validation of Novel Predictive Score for Patients With Spinal Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Metastases
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 219
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: Patients with spinal metastases

Brief summary: The investigators are prospectively validating a prognostic clinical tool that uses a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin to predict survival, post-treatment morbidity, and functional outcomes in patients with metastatic disease involving the spine.

Detailed description: Recently, the investigators proposed a clinical prediction score that used a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin as a means to predict long-term survival following spine surgery for metastatic disease. This prognostic utility was developed using one-year mortality as the sole outcome measure. While the scoring system demonstrated many of the necessary attributes of a useful prediction tool, including simplicity, ease of use and clinical utility, it has yet to be validated prospectively and its capacity to predict other peri-operative outcomes, including physical and mental function following intervention, pain relief and the risk of complications, remain incompletely explored. To further evaluate the utility of this prognostic score, the investigators propose a series of three integrated experiments that will prospectively determine its capacity to accurately inform clinical decision making and recommendations for surgery for patients with metastatic spinal disease.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years of age
2. Confirmed diagnosis of cancer with metastatic spread to the mobile spine or sacrum
3. Able to consent for themselves at the time of the intake evaluation
4. Speaks English

   Exclusion Criteria:
5. Primary bone tumors or leukemia
6. Metastases to other visceral or skeletal locations, without involvement of the spine or sacrum
7. History of prior spine surgery for metastatic disease

Primary outcomes:
measure: Survival
timeFrame: Up to 3 years
measure: EuroQuol 5-Dimension (EQ5D) profile
timeFrame: Up to 3 years
measure: Short-Form (SF)-12
timeFrame: Up to 3 years
measure: Visual Analog Scale (VAS) for pain
timeFrame: Up to 3 years
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Post-treatment morbidity and readmissions
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Andrew Schoenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02295150: Prophylaxis of Venous Thromboembolism After Bariatric Surgery
Official title: Prospective, Pharmacokinetic Study for Determination of the Relationship Between Lean Body Weight and Anti-Xa Activity 4 Hours After Subcutaneous Injection of 5700 IU Nadroparin in Morbidly Obese Patients After Bariatric Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Morbid Obesity
Thromboembolism
Bypass Complications
Keywords: Nadroparin
Anti-Xa activity
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is a prospective evaluation of the relationship between lean body weight and anti-Xa activity and 5700 International Units (IU) nadroparin 4 hours after subcutaneous administration in morbidly obese patients after bariatric surgery.

Detailed description: There is no guideline for postoperative thromboembolic prevention in morbidly obese patients.

The investigators goal is to examine which dose of nadroparin is effective.

Eligibility criteria: Inclusion Criteria:

* Approval for Roux-en-Y gastric bypass
* Total body weight \> 140 kg

Exclusion Criteria:

* Renal impairment (GFR \< 30ml/min and/ or serum creatinin \> 150 micromol/ml)
* Coagulation disorders
* Use of vitamin K antagonists (such as acenocoumarol) pregnancy

Primary outcomes:
measure: anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Wagnerlaan 55
Study officials:
affiliation: Rijnstate Hospital
name: F.J. Berends, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: