louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00892879: A Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy
Official title: A Randomized Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cholecystectomy, Laparoscopic
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
First posted: 2009-05-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-institution, prospective, one-to-one randomized controlled research study. Subjects medically determined to need a cholecystectomy will be consented for surgery and study participation prior to enrolment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* Pre-operative diagnosis of one of the following:

  * Pancreatic cholecystitis
  * Biliary cholic
  * Biliary dyskinesia
  * Choledocholithiasis status post endoscopic retrograde cholangiopancreatography/sphincterotomy
  * Gallbladder polyps
  * Other diagnosis at the discretion of the surgeon

Exclusion Criteria:

* Acute cholecystitis
* Gallstones \> 2.5cm in length on ultrasound
* Suspected presence of common duct stones
* History of jaundice
* History of gallstone pancreatic

Primary outcomes:
measure: Post-operative pain scores (visual analogue pain scale from 0-10)assessed on post-operative day 1 and at the post-operative follow up visit in clinic. The mean pain scores will be compared using student's t-test.
timeFrame: 3-6 weeks
Secondary outcomes:
measure: The postoperative infection rate will be monitored and compared for patients undergoing single port laparoscopic cholecystectomy and four port laparoscopic cholecystectomy.
timeFrame: 3-6 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
Study officials:
affiliation: Providence Health & Services
name: Paul D Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ma J, Cassera MA, Spaun GO, Hammill CW, Hansen PD, Aliabadi-Wahle S. Randomized controlled trial comparing single-port laparoscopic cholecystectomy and four-port laparoscopic cholecystectomy. Ann Surg. 2011 Jul;254(1):22-7. doi: 10.1097/SLA.0b013e3182192f89.
Clinical trial NCT00658879: Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan
Official title: SPECIAL INVESTIGATION OF SOMAVERT -LONG TERM USE-
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-15
Enrollment: 251
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A6291023 prescribes Somavert (Pegvisomant).

Brief summary: The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed description: All the patients whom an investigator prescribes the first Somavert (Pegvisomant) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria: Inclusion Criteria:

Patients need to be administered Somavert (Pegvisomant) in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered Somavert (Pegvisomant).

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: 5 years
measure: Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
timeFrame: 5 years
measure: Number of Participants With Treatment-Related Adverse Events by Gender
timeFrame: 5 years
measure: Number of Participants With Treatment-Related Adverse Events by Age
timeFrame: 5 years
measure: Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder
timeFrame: 5 years
measure: Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment
timeFrame: 5 years
measure: Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease)
timeFrame: 5 years
measure: Clinical Effectiveness Rate
timeFrame: 5 years
measure: Clinical Effectiveness Rate by Gender
timeFrame: 5 years
measure: Clinical Effectiveness Rate by Age
timeFrame: 5 years
measure: Clinical Effectiveness Rate in Participants With Hepatic Function Disorder
timeFrame: 5 years
measure: Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01975779: Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AE58054 in Healthy Japanese and Caucasian Subjects
Official title: Interventional, Randomised, Double-blind, Placebocontrolled, Single- and Multiple-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AE58054 in Healthy Japanese and Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2013-11-05
Enrollment: 42
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of single- and multiple doses of Lu AE58054 in healthy young Japanese men in comparison with Caucasian men.

Detailed description: The study will be conducted in two parts.

Part A consists of two cohorts (named cohort A1 and A2), which are randomised, double-blind, parallel-group, placebo-controlled, single- and multiple dose regimens investigating the safety, tolerability, and pharmacokinetics of Lu AE58054 in healthy young men.

Part B consists of one cohort, B1, which is a randomised, open-label, two-way cross-over, single dose investigation of the effect of food on the pharmacokinetics of Lu AE58054 in healthy young Japanese men.

Eligibility criteria: Inclusion Criteria:

* Healthy Japanese (Japanese passport, four Japanese grandparents, and lives outside Japan for less than 5 years) or Caucasian men aged 20 to 45 years with a BMI between 18 and 25 kg/m2 (extremes included).

Exclusion Criteria:

* The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Number and frequency of adverse events
timeFrame: Up to Day 13
measure: Number of subjects with adverse events
timeFrame: Up to Day 13
Secondary outcomes:
measure: Area under the Lu AE58054 plasma concentration-time curve in a dosing interval (AUC0-tau)
timeFrame: Day 9
measure: Area under the Lu AE58054 plasma concentration-time curve from zero to infinity (AUC0-inf)
timeFrame: Day 1
measure: Maximum observed concentration (Cmax) and time of observation (tmax)
timeFrame: Day 1 and Day 9
measure: Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination halflife (t½)
timeFrame: Day 1 and Day 9
measure: Accumulation index following multiple dosing of Lu AE58054 (AI)
timeFrame: Day 9
measure: Risk of Suicidality
timeFrame: Up to Day 13
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GB001
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT03283579: Fatty Acids and Attention Deficit and Hyperactivity Disorder Symptoms
Official title: Prenatal Omega-6/Omega-3 Ratio and Attention Deficit and Hyperactivity Disorder Symptoms in Children: a Population-based Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Behavior Problem
Attention Deficit Hyperactivity Disorder
Fatty Acid Deficiency
Lead sponsor: Barcelona Institute for Global Health
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 2644
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was based on data from a population-based birth cohort, INMA (Infancia y Medio Ambiente \[Environment and Childhood\]) project, including four Spanish regions: Asturias (n=494) and Gipuzkoa (Basque Country) (n=638) on the Cantabrian coast, and Sabadell (Catalonia) (n=657) and Valencia (n=855) on the Mediterranean coast.

Brief summary: This study aimed to evaluate the longitudinal association between n-6:n-3 LCPUFAs ratio in cord blood and child ADHD symptoms at 4 and 7 years old. This study was based on the INMA project, a population-based birth cohort in Spain. Higher cord blood n-6:n-3 ratio was associated with higher subclinical ADHD symptoms during early and mid-childhood.


Eligibility criteria: Inclusion criteria:

* Age 16 years or older
* Singleton pregnancy
* No use of assisted reproductive techniques
* Intention to deliver at the reference hospital
* Ability to speak and understand Spanish or a local language

Primary outcomes:
measure: Fatty acid ratio in cord blood
timeFrame: 2004-2008
measure: ADHD 4 years old
timeFrame: 2008-2012
measure: ADHD 7 years old
timeFrame: 2012-2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01707979: NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes
Official title: NIR (Near Infrared)- Spectroscopy and Multifrequent Impedance Spectroscopy on the Skin to Detection of Sensory and Autonomic Neuropathy Among Patients With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Neuropathy
Keywords: Near infrared light
Diabetic neuropathy
Sensory neuropathy
Autonomic neuropathy
Vagus
Sudomotor function
Monofilament
Impedance
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 30
Sex: MALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Control group men without diabetes Type1 diabetic men without neuropathy complications Type 1 diabetic men with neuropathy complications

Brief summary: The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR and impedance.

Detailed description: The aim of the study is to examine how suitable a hand-held measuring probe (DDD-probe) using NIR (near infrared light) as well as impedance (conductivity), is to detect early signs of diabetic neuropathy.

The DDD-probe is put directly on the skin and is measuring by the use of light and impedance.

Eligibility criteria: Inclusion Criteria:

* men with type 1 diabetes (WHO criteria)
* age 35-50 years
* duration of diabetes \> 10 years

Exclusion Criteria:

* P-creatinine\> 120 micromol/l
* other acute or chronic disease, or type of treatment that makes the patient unsuitable to participate, valuated by the investigator
* non intact skin on the measuring spots
* the patient is unable to understand the informed consent

Primary outcomes:
measure: near infrared spectroscopy
timeFrame: one time
Secondary outcomes:
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Lise Tarnow, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05873179: Effects on Emphathy in Physiotherapy Students After Simulation as an Active Method for Learning the Clinical Enterview
Official title: Effects on Emphathy in Physiotherapy Students After Simulation With Kirkpatric Evaluation as an Active Method for Learning the Clinical Enterview
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Students
Keywords: Medical education
nursing education
physiotherapy
empathy
Lead sponsor: Mayuben Private Clinic
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women who are studying the first year of Physiotherapy at the Complutense University of Madrid and wish to participate in the study.

Brief summary: The aim of the main study is to find out the effects on empathy in physiotherapy students after role playing in the learning of the clinical history.

Detailed description: Thirty-one first-year physiotherapy students will carry out the role-playing methodology to learn how to take a clinical history in physiotherapy.

Before and after the realization, they will be measured by means of a validated questionnaire in Spanish, the language in which they study, the variable of empathy.

Eligibility criteria: Inclusion Criteria:

* Men and women who are studying the first year of Physiotherapy at the Complutense University of Madrid and wish to participate in the study.

Exclusion Criteria:

* Students who do not wish to participate in the study.

Primary outcomes:
measure: Jefferson Scale or Medical Empathy Scale before role playing
timeFrame: Through study completion, an average of 1 week
measure: Empathy Quotent before role playing.
timeFrame: Through study completion, an average of 1 week
measure: Jefferson Scale or Medical Empathy Scale after role playing
timeFrame: Through study completion, an average of 1 week
measure: Empathy Quotent after role playing
timeFrame: Through study completion, an average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Eva María Martínez-Jimenez
Study officials:
References:
Clinical trial NCT02868879: Anatomical and Structural Connectivity in Two Psychotic Phenotypes : Periodic Catatonia and Cataphasia
Official title: Anatomical and Structural Connectivity in Schizophrenias
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Catatonia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Schizophrenia patients (subdivided in periodic catatonia and cataphasia) and normal controls, both having the same procedure.

Brief summary: The different subtypes of Schizophrenia might have a disordered connectivity as their final common pathways.

The investigators will use multimodal structural MRI to assess anatomical connectivity on the one side and its functional consequence on functional connectivity on the other side to assess two phenotypes of psychosis : periodic catatonia and cataphasia in comparison with control subjects.

The coherence between structural and functional anomalies will be especially studied.


Eligibility criteria: Inclusion criteria (controls):

* Aged from 18-65 Y
* Right handed

Additional inclusion criteria for patients:

* Schizophrenia according to the DSM5
* Either periodic catatonia or cataphasia according to the WKL classification
* Under stable medication regimen (\> 1M)

Exclusion criteria:

* Current substance abuse
* Contraindication to MRI
* Past records susceptible to affect brain integrity
* Severe, unstable medical condition
* Pregnancy
* Patients deprived of their rights

Primary outcomes:
measure: Changes in structural and functional connectivity according to the phenotype. Correlation between these changes
timeFrame: Subjects will be assessed only once.
Secondary outcomes:
measure: Changes in rCBF and cognition according to the phenotype. Correlation between the different changes and the symptomatic scales.
timeFrame: Subjects will be assessed only once.
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Study officials:
References:
citation: Foucher JR, Zhang YF, Roser M, Lamy J, De Sousa PL, Weibel S, Vidailhet P, Mainberger O, Berna F. A double dissociation between two psychotic phenotypes: Periodic catatonia and cataphasia. Prog Neuropsychopharmacol Biol Psychiatry. 2018 Aug 30;86:363-369. doi: 10.1016/j.pnpbp.2018.03.008. Epub 2018 Mar 17.
Clinical trial NCT00647179: Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment
Official title: Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Excessive Growth Hormone Secretion
Insulin Resistance
Keywords: Acromegaly
Growth Hormone
Insulin resistance
Glucose tolerance
Body Composition
Substrate metabolism
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2008-03-31
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patiens recently diagnoses with acromegaly, recruited from the clinic

Brief summary: The purpose of this study is to investigate the effects of chronic elevated growth hormone on metabolism and insulin sensitivity by studying acromegalic patients before and after treatment.


Eligibility criteria: Inclusion Criteria:

* Written consent
* Age between 18 and 70
* Recently diagnosed with acromegaly

Exclusion Criteria:

* NYHA 3
* Uncontrolled hypertension
* Known cerebrovascular disease
* Proliferative retinopatia

Primary outcomes:
measure: Insulin sensitivity
timeFrame: Before and after treatment
Secondary outcomes:
measure: QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, Glucose tolerance
timeFrame: Before and after treatment
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Endocrinology, Aarhus University Hospital
state: Aarhus
Study officials:
affiliation: Aarhus University Hospital, Department of Endocrinology
name: Jens Otto L. Jørgensen, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arlien-Soborg MC, Grondahl C, Baek A, Dal J, Madsen M, Hogild ML, Pedersen SB, Bjerre M, Jorgensen JOL. Fibroblast Activation Protein is a GH Target: A Prospective Study of Patients with Acromegaly Before and After Treatment. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz033. doi: 10.1210/clinem/dgz033.
Clinical trial NCT00615979: Far Forward Battlefield Telemedicine: Evaluation of Handheld Ultrasound
Official title: Far Forward Battlefield Telemedicine:Ultrasound Guidance System (UGS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Injuries
Keywords: trauma
portable ultrasound
telemedicine
Department of Defense
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2008-02-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for clinical echocardiographic study Patients with possible diagnosis of cardiac tamponade

Brief summary: The goal of this study is to improve survival of battlefield trauma through ultrasound telemedicine and remotely guided therapeutics.

Detailed description: Specific aims to meet to improve the survival of battlefield trauma are 1)validation of portable ultrasound for diagnosis of various medical and surgical emergencies, ie cardiac tamponade, intraabdominal hemorrhage, 2)Extension of our expertise in digital echocardiography and local telemedicine to support other centers in such procedures as TEE 3)development of wireless telemedicine systems for rapid relay of ultrasonic images from portable ultrasound system to a remote review station. 4)development of a precision guide for diagnostic and therapeutic percutaneous procedures using ultrasound guidance 5)combining wireless telemetry with the guided percutaneous access tool to permit remotely guided emergency procedures 6)augmenting this work(2D/echo) with 3D/echo.

Eligibility criteria: Inclusion Criteria:

* 18-80 yrs old
* Scheduled for clinical echocardiogram

Exclusion Criteria:

* None

Primary outcomes:
measure: Validation of small portable ultrasound units
timeFrame: single time point
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: James Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References: