louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04669314: Surgical Approach in Liver Hemangiomas
Official title: Surgical Approach in Liver Hemangiomas With Special Emphasis on Lesion Diameter and Type of Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemangioma Liver
Keywords: hemangioma
liver resection
enucleation
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent surgery for liver hemangioma between 2007 and 2018 at Ankara University Hospitals

Brief summary: Operations performed for liver hemangioma between January 2017 and December 2018 will be retrospectively analyzed.

Detailed description: Operations performed for liver hemangioma at Ankara University Hospitals will be retrospectively analyzed. Patient and disease characteristics including demographics, laboratory tests, imaging studies, type of surgical approach and outcomes including postoperative laboratory tests, record of complications, duration of hospital stay will be reviewed. Complications were classified according to Clavien-Dindo classification. The patients were informed about the surgeries in advance and their informed consents about surgeries and data collection for scientific purposes were obtained. Datafile will be anonymized before analysis and original file will be destroyed. Outcomes such as complications, hospital stay, blood transfusion and mortality will be compared between groups created according to type of surgery, lesion size, preoperative laboratory values and demographic features. Variables for prediction of better outcomes are expected to be discovered.

Eligibility criteria: Inclusion Criteria:

* Patients underwent surgery for liver hemangioma

Exclusion Criteria:

* Cases lacking of more than 20% of critical data

Primary outcomes:
measure: Complications
timeFrame: Complications reported within 3 months after surgery will be evaluated within 15 days after completion of data collection
Secondary outcomes:
measure: Hospital stay
timeFrame: Hospital stay starting with operation and ends with discharge will be compared within 15 days after completion of data collection
measure: Transfusion
timeFrame: Erythrocyte transfusion during surgery will be analyzed within 15 days after completion of data collection
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Ibni Sina Hospital
Study officials:
References:
Clinical trial NCT00431314: Effect of Hemodialysis on Toe Pressure- and Finger Pressure and Skin Autofluorescence in Hemodialysis Patients
Official title: The Effect of Hemodialysis on Toe Pressure- and Finger Pressure Measurements and Measurement of Skin Autofluorescence; a Pilot Study in the Assessment of Critical Limb Ischemia in Hemodialysis Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Keywords: End Stage Renal Disease
Hemodialysis
Critical Limb Ischemia
Autofluorescence
Lead sponsor: Isala
Sponsor class: OTHER
Collaborators: name: Dutch Diabetes Research Foundation
First posted: 2007-02-05
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hemodialysis patients in one hemodialysis centre

Brief summary: The aim of this study is to determine the vascular condition of hemodialysis patients with toe pressure measurement, finger pressure measurement and measuring glycated and oxidated proteins by skin autofluorescence.

Hypothesis: Lowering of finger pressure/toe pressure during hemodialysis, especially in whom with a arteriovenous fistula, may contribute to critical limb ischemia in the extremities.

Detailed description: 1. To determine the macrovascular status of hemodialysis patients by measuring toe pressure, finger pressure and skin autofluorescence.
2. Measuring toe- and finger pressure before and during hemodialysis to determine the chance of developing critical limb ischemia in the extremities.
3. To assess the differences in finger pressure in hemodialysis patients before and during hemodialysis in patients with either arteriovenous fistula in the upper extremity or not.
4. To predict mortality and cardiovascular disease by determine the fastness of accumulation of Advanced-Glycation-Endproducts (this concerns follow-up measurements of skin autofluorescence; another study has collected data of skin autofluorescence in hemodialysis patients in our centre in 2003)

Eligibility criteria: Inclusion Criteria:

* Patients with End Stage Renal Disease with hemodialysis therapy

Exclusion Criteria:

* Hemodialysis during the night
* Dark coloured skin towards unreliable skin autofluorescence measurements

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Center of Excellence Diabetes
name: Henk J Bilo, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02798614: Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures
Official title: A Comparison of Radiographic and Clinical Results After Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colles' Fracture
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 109
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the radiographic and clinical outcomes after short versus conventional plaster cast fixation time in reduced distal radius fractures.

Detailed description: Displaced distal radius fractures treated with closed reduction and plaster cast fixation are radiographed 10 days (range 8-13 days) after reduction and randomized to one of two study arms; immediate removal of plaster cast or continued fixation in plaster cast for another 3 weeks. Radiographic and Clinical outcome measurements at 1, 4 and 12 months

Eligibility criteria: Inclusion Criteria:

* Distal radius fracture with intact ulna (except for processus styloideus ulnae)
* Dorsal angulation 5-40 degrees
* Axial compression \< 4 mm
* Intra articular step-off \< 1 mm
* Low energy trauma
* Closed fracture
* Suitable for treatment with closed reduction and plaster cast fixation

Exclusion Criteria:

* Fracture older than 3 Days
* Previously fractured ipsi- or contralateral wrist
* Dementia
* Inflammatory joint disorder

Primary outcomes:
measure: Radiographic displacement
timeFrame: At admission, 10 days, 1 month and 12 months
Secondary outcomes:
measure: Grip strength
timeFrame: Uninjured side. Injured side at 1, 4 , 12 months
measure: Range of motion
timeFrame: Uninjured side. Injured side at 1, 4 and 12 months
measure: Assessment of pain intensity
timeFrame: 10 days, 1, 4 and 12 months
measure: Assessment of functional outcome with three different functional assessment scores; 1,The modified de Bruijn wrist score 2, The modified Mayo wrist scoring chart 3, The Gartland and Werley Demerit wrist point system modified by Sarmiento.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Orthopaedics, University Hospital of Uppsala
name: Albert Christersson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christersson A, Larsson S, Ostlund B, Sanden B. Radiographic results after plaster cast fixation for 10 days versus 1 month in reduced distal radius fractures: a prospective randomised study. J Orthop Surg Res. 2016 Nov 21;11(1):145. doi: 10.1186/s13018-016-0478-7.
Clinical trial NCT01912014: Psychosocial Wellbeing Following Stroke
Official title: Psychosocial Wellbeing Following Stroke: Developing and Testing a Psychosocial Nursing Intervention for Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Psychosocial
Narrative
Coping
Quality of Life
Keywords: stroke
psychosocial
intervention
quality of life
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this feasibility study is to develop and initially test a dialogue-based psychosocial intervention aimed at promoting coping and psychosocial wellbeing following an acute stroke. The intervention is carried out by primary care registered nurses or other appropriate health professionals. The intervention included persons with and without aphasia.


Eligibility criteria: Inclusion Criteria:

* 18 years old or above
* acute stroke
* 4-8 weeks poststroke

Exclusion Criteria

* Other serious disease

Primary outcomes:
measure: Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39)
timeFrame: baseline and 2 weeks after end of intervention
Secondary outcomes:
measure: Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39)
timeFrame: baseline and 12 months after end of intervention
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University hospital
Study officials:
References:
citation: Kirkevold M, Bronken BA, Martinsen R, Kvigne K. Promoting psychosocial well-being following a stroke: developing a theoretically and empirically sound complex intervention. Int J Nurs Stud. 2012 Apr;49(4):386-97. doi: 10.1016/j.ijnurstu.2011.10.006. Epub 2011 Nov 1.
citation: Bronken BA, Kirkevold M. Between the lines: generating good qualitative data in studies involving persons with aphasia. ANS Adv Nurs Sci. 2013 Apr-Jun;36(2):E14-28. doi: 10.1097/ANS.0b013e318290200a.
citation: Bronken BA, Kirkevold M, Martinsen R, Wyller TB, Kvigne K. Psychosocial well-being in persons with aphasia participating in a nursing intervention after stroke. Nurs Res Pract. 2012;2012:568242. doi: 10.1155/2012/568242. Epub 2012 Jul 22.
citation: Kirkevold M, Martinsen R, Bronken BA, Kvigne K. Promoting psychosocial wellbeing following stroke using narratives and guided self-determination: a feasibility study. BMC Psychol. 2014 Feb 3;2(1):4. doi: 10.1186/2050-7283-2-4. eCollection 2014.
Clinical trial NCT03581214: Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate
Official title: Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Resuscitation
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-07-10
Enrollment: 910
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: Approximately 2/3 of laboring women receive supplemental oxygen (O2) in an attempt to reverse perceived fetal hypoxia on electronic fetal monitoring (EFM). O2 supplementation is most commonly used in patients with Category II EFM, a class of EFM patterns designed in part to identify fetal acidemia. This liberal use of O2 in laboring patients is concerning because hyperoxygenation in infants is associated with adverse outcomes including retinopathy and abnormal neurodevelopment. Furthermore, excess O2 exposure is linked to free radical generation and subsequent oxidative cell damage. This calls for a closer look at the safety of intrauterine O2 exposure. The proposed project explores potential mechanisms for harm with maternal O2 supplementation in laboring patients with Category II EFM. Specifically, this project will determine the effect of O2, compared to room air (RA), on umbilical cord and maternal levels of malondialdehyde (MDA) and 4-hydroxynonenal (4-HNE), markers of free radical-induced oxidative stress. The study will also explore the correlation between urinary and blood markers of oxidative stress. Banked specimens will be used to investigate the potential effect of peripartum O2 exposure on placental oxidative stress in the future.


Eligibility criteria: Inclusion Criteria:

* Singleton
* Gestational age ≥37 weeks
* Spontaneous labor or induction of labor
* English speaking
* Ability to give informed consent

Exclusion Criteria:

* Major fetal anomaly
* Multiple gestation
* Category III electronic fetal monitoring
* Maternal hypoxia
* Preeclampsia
* Intrauterine growth restriction
* Pregestational diabetes
* Tobacco use

Primary outcomes:
measure: Umbilical Artery Malondialdehyde
timeFrame: At delivery
measure: Umbilical Artery 4-hydroxynonenal
timeFrame: At delivery
measure: Maternal Malondialdehyde
timeFrame: Within 1 hour of delivery
measure: Maternal 4-hydroxynonenal
timeFrame: Within 1 hour of delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
Study officials:
References:
Clinical trial NCT00129714: Westeinde Brachialgia Study
Official title: A Randomized Controlled Trial of Conservative Therapy in Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiculopathy, Cervical
Keywords: cervical radiculopathy conservative treatment
Lead sponsor: Medical Center Haaglanden
Sponsor class: OTHER
First posted: 2005-08-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Westeinde Brachialgia Study (WEB) is a randomized controlled trial to establish the effect of cervical collar or physiotherapy compared to a wait-and-see policy in patients with acute cervical radiculopathy.

Detailed description: Cervical radiculopathy caused by spondylosis or disc protrusion is a common disorder with a usually benign natural course. Often, physiotherapy (exercise programs) and/or cervical collar are prescribed. However, there are no reliable data on the effects of these conservative therapies.

In this study, patients with acute cervical radiculopathy, defined by clinical criteria, are randomized for cervical collar, physiotherapy or a wait-and-see policy.

Eligibility criteria: Inclusion Criteria:

* Cervical radiculopathy defined by neck pain irradiating to one arm with at least one of the following: provocation by neck movements or sensory changes in one or more adjacent dermatomes or diminished deep tendon reflexes in the affected arm; or muscle weakness in one or more adjacent myotomes.

Exclusion Criteria:

* Arm pain existing longer than one month
* Clinical signs of spinal cord compression
* Previously treated with physiotherapy or a cervical collar

Primary outcomes:
measure: pain and disability at 3 and 6 weeks and at 6 months
Secondary outcomes:
measure: time back to work
measure: persistent signs and symptoms
measure: surgery
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Meander Medical Center
city: Den Haag
country: Netherlands
facility: Medical Center Haaglanden
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
Study officials:
affiliation: Medical Center Haaglanden
name: Jos TJ Tans, MD PhD
role: STUDY_CHAIR
References:
citation: Kuijper B, Tans JT, Beelen A, Nollet F, de Visser M. Cervical collar or physiotherapy versus wait and see policy for recent onset cervical radiculopathy: randomised trial. BMJ. 2009 Oct 7;339:b3883. doi: 10.1136/bmj.b3883.
citation: Kuijper B, Tans JT, Schimsheimer RJ, van der Kallen BF, Beelen A, Nollet F, de Visser M. Degenerative cervical radiculopathy: diagnosis and conservative treatment. A review. Eur J Neurol. 2009 Jan;16(1):15-20. doi: 10.1111/j.1468-1331.2008.02365.x.
Clinical trial NCT01272414: Use of Botox in the Management of Thyroid Related Upper Eyelid Retraction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Graves Ophthalmopathy
Keywords: Eyelid retraction
Botulinum Toxins
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2011-01-07
Enrollment: 0
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: Currently there are few therapeutic options for the treatment of lid retraction secondary to thyroid orbitopathy (TO) during the active stages of the disease. BoTox injection is capable of creating a ptosis, that in the setting of TO can return the upper lid to a more physiologic position, thus improving cosmesis, corneal lubrication and potentially quiescent stage lid position. This investigation aims to examine the properties of this relationship.


Eligibility criteria: Inclusion Criteria:

* Active stage thyroid orbitopathy, as determined by symptom onset of under 6 months.
* Upper eyelid retraction of 1mm or greater.
* Complaining of either significant ocular symptoms (despite appropriate use of ocular lubricants), or bothered by the cosmetic deformity associated with the eyelid retraction.

Exclusion Criteria:

* Less than 18 years of age
* Age over 65 years
* Pregnant or nursing
* Known peripheral neuropathy or neuromuscular junction disorder
* Demonstrated allergy to BoTox
* Current infection over the injection site
* Are currently taking any of the following medications: aminoglycosides, penicillamine, quinine, and calcium channel blockers.
* Previous or concurrent prednisone therapy
* Undergone previous upper eyelid surgery
* Severe vision threatening TO

Primary outcomes:
measure: Reduction in upper lid retraction (in mm)
timeFrame: 4 month
Secondary outcomes:
measure: Subjective improvement in lid retraction related dry eye symptoms
timeFrame: 4 months
measure: Subjective improvement in lid retraction related cosmesis
timeFrame: 4 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Daniel B Rootman, MSc MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Nancy Tucker, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03148314: Vaginal Misoprostol In Management Of First Trimester Missed Abortion.
Official title: Home-Based Extended Low Dose Buccal Misoprostol Versus Hospital-Based Standard Vaginal Dose In Management Of First Trimester Missed Abortion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Abortion, Missed
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The world health organization defined abortion or miscarriage as : the expulsion or extraction from its mother of a fetus or an embryo weighting 500 grams or less ,or any other wise product of gestation of any weight irrespective of gestational age and weather or not there is evidence of life and weather or not the abortion was spontaneous or induced Miscarriage is the most common complication of pregnancy occurring in 10-20% of clinically recognized pregnancies (Bag. It is estimated that around 40% of early pregnancies result in miscarriage. A large majority of those are lost before the menstrual period is missed. More than 80%of abortions occur in first 12 weeks of pregnancy, and the rate decrease there after For clinical purposes: abortion is subdivided into: threatened abortion, inevitable abortion, incomplete abortion ,missed abortion ,septic abortion ,and recurrent abortion


Eligibility criteria: Inclusion Criteria:

* single dead fetus up-to 12 weeks.
* no low lying placenta
* no scarred uterus
* no or mild bleeding
* no evidence of infection
* accepting to participate in the study.

Exclusion Criteria:

* Advanced hepatic diseases .
* Suspected molar pregnancy
* Ectopic pregnancy or pregnancy of unknown location
* Haemodynamically unstable with significant anaemia ie Hb\<10
* Uncontrolled severe asthma
* Chronic adrenal failure
* Known or suspected heart disease
* Glaucoma
* Haemoglobinopathies
* Haemorrhagic disorders and anti-coagulation therapy (aspirin accepted)
* Adrenal suppression and long term glucocorticoid therapy (may require corticosteroid)
* Patient living in remote areas with difficulty in accessing hospital

Primary outcomes:
measure: Percentage of patients with complete abortion (success rate).
timeFrame: 1 week
Secondary outcomes:
measure: Number of misoprostol doses
timeFrame: 1 week
measure: induction-abortion time
timeFrame: 1 week
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
citation: Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
Clinical trial NCT01219114: Safety and Efficacy Study of CUBICIN (Daptomycin) Under Conditions of Actual Use
Official title: A Descriptive Study of the Efficacy and Safety of CUBICIN (Daptomycin) Under Conditions of Actual Use in the Philippines
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Complicated Skin and Skin Structure Infections and Bacteremia Including Right-sided Endocarditis
Keywords: Daptomycin
endocarditis
complicated skin and skin structure infection
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: several private and government tertiary hospitals

Brief summary: The purpose of this study is to monitor the safety and efficacy of CUBICIN under conditions of actual use in patients who are diagnosed with complicated Skin and Skin Structure infection (cSSI) or Staphylococcus aureus bacteria including right-sided endocarditis and are prescribed CUBICIN by their physician.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cSSSI known or suspected to be due to gram-positive bacteria
* Diagnosis of right-sided endocarditis with one or more positive culture for S. aureus within two days prior to initiation of medication
* Prescribed daptomycin by patient's attending physician

Exclusion Criteria:

* Known allergic or serious adverse reaction to daptomycin
* Patients with pneumonia
* Patients with baseline CPK values \>1000 U/L or 5x ULN

Primary outcomes:
measure: Adverse events observed during the treatment duration
timeFrame: Ranges from during treatment and up to 14 days after last administration of daptomycin (follow up)
measure: Clinical Response determined by cure rate
timeFrame: Ranges from during treatment and up to 14 days after last administration of daptomycin
Secondary outcomes:
Other outcomes:
Locations:
city: Lipa City
country: Philippines
facility: Research Site
state: Batangas
city: Davao City
country: Philippines
facility: Research Site
state: Davao
city: Iloilo City
country: Philippines
facility: Research Site
state: Iloilo
city: Pasig City
country: Philippines
facility: Research Site
state: Metro Manila
city: Quezon City
country: Philippines
facility: Research Site
state: Metro Manila
Study officials:
affiliation: AstraZeneca Philippines
name: Milagros Tan, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca Philippines
name: Emmanuel Arca, MD
role: STUDY_CHAIR
References: