louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00968877: Vitamin D and Chronic Renal Insufficiency
Official title: Vitamin D and Chronic Renal Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitamin D Deficiency
Chronic Renal Insufficiency
Keywords: Renal Insufficiency
Cholecalciferol
Kidney Disease
Kidney Failure
Vitamin D
Vitamin D Deficiency
Vitamin D3
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2009-08-31
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose of this study is to investigate the effect of treatment with vitamin D3 (cholecalciferol) compared with placebo in a trial including chronic kidney disease patients with vitamin D deficiency.

Detailed description: Most patients with chronic renal insufficiency have vitamin D deficiency. It is still not common practice among nephrologists to monitor and correct vitamin D deficiency of chronic kidney disease (CKD) patients, because it is widely believed that any vitamin D deficiency associated with calcium-phosphate disturbances is better treated with activated vitamin D.

However, correction of vitamin D deficiency with native vitamin D seems to have numerous favorable effects not only related to the renal and intestinal handling of calcium and phosphate. It may have beneficial effects on bone and vascular health, the immune system and physical performance that are not obtained with active vitamin D treatment.

We are therefore planning a randomized, placebo-controlled, intervention study of 8 weeks' duration in which vitamin D3 supplementation (40 000 IE per week in one capsule) is compared with placebo in a trial including 120 CKD patients with vitamin D deficiency. Multiple biological variables are monitored in order to assess any effect on the biological systems of interest.

Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease (CKD 3-5 amd renal transplanted patients)
* Age \> 18 years
* Vitamin D insufficiency or deficiency (25-OHD \< 50 nmol/l, 3 months before project start)

Exclusion Criteria:

* Treatment with vitamin D2/D3 (dose more than 10000 IU within the last 3 months)
* Hypercalcaemia (ca++ \> 1,35 mmol/l more than 4 weeks despite missing intake of calcium containing preparations and activated vitamin D)
* Uncontrolled hyperphosphataemia (s-phosphate \> 2,2 mmol/l)
* Sarcoidosis
* Malignant disease
* Psychotic disorders
* Pregnancy and lactation women
* Allergy to soya and peanut

Primary outcomes:
measure: Calcium phosphate associated metabolites, bone markers, endothelial markers, inflammation muscle function, pulse wave velocity test
timeFrame: 8 weeks
Secondary outcomes:
measure: Health questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Nephrological department, Odense University Hospital
name: Peter Marckmann, Prof, DMSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01234077: Study Comparing In-laboratory Polysomnography Electrocardiogram (PSG ECG) to Simultaneously Recorded In-laboratory ECG on the CPC M1 Device
Official title: A Single Blind Randomized Study Comparing In-laboratory Polysomnography Electrocardiogram to Simultaneously Recorded In-laboratory Electrocardiogram on the CPC M1 Device and Compared to Home Recorded Electrocardiogram With the CPC M1 Device.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Keywords: scheduled for a polysomnogram (overnight sleep study)
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: MyCardio
First posted: 2010-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Research study that will test a portable device (CPC M1) that records: body movement; heart activity (ECG; snoring; and body position during sleep. The Food and Drug Administration (FDA) has not approved this device for use except in a research setting.

The purposes of this study are to: a) determine if the ECG data collected using the CPC M1 device is at least as good as the ECG data collected during a diagnostic, in-lab polysomnogram (PSG) (or sleep study) and b) determine if in-home monitoring with the device will provide similar results compared to an in-lab PSG.


Eligibility criteria: Inclusion Criteria:

1. Adults (males and females) 18 to 70 years of age with a suspected sleep disorder.
2. Subjects or legal guardians are able to verbalize an understanding of the consent form, provide written informed consent, and verbalize willingness to complete study procedures.
3. Adequate dexterity to apply and remove the CPC M1 device.

Exclusion Criteria:

1. Patients with atrial fibrillation and ventricular tachycardia.
2. Patients with an inability to apply the CPC M1 device.
3. Pregnancy.

Primary outcomes:
measure: Sensitivity and specificity of an electrocardiogram-based method to predict the presence of a sleep disorder.
timeFrame: 6 months
measure: Sensitivity and specificity of an electrocardiogram-based method to predict the presence of a sleep disorder.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: John Harrington, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Magnusdottir S, Hilmisson H. Ambulatory screening tool for sleep apnea: analyzing a single-lead electrocardiogram signal (ECG). Sleep Breath. 2018 May;22(2):421-429. doi: 10.1007/s11325-017-1566-6. Epub 2017 Sep 7.
citation: Harrington J, Schramm PJ, Davies CR, Lee-Chiong TL Jr. An electrocardiogram-based analysis evaluating sleep quality in patients with obstructive sleep apnea. Sleep Breath. 2013 Sep;17(3):1071-8. doi: 10.1007/s11325-013-0804-9. Epub 2013 Jan 25.
Clinical trial NCT04300777: The Fixation Study
Official title: Clinical Evaluation of the SeaSpine Non-Cervical Pedicle Screw Systems
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Conditions, Neurologic
Lead sponsor: SeaSpine, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-09
Enrollment: 50
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 who have been implanted with a SeaSpine Non-Cervical Pedicle Screw System

Brief summary: To perform a clinical evaluation of safety and performance for the SeaSpine Non- Cervical Pedicle Screw Systems

Detailed description: A multi-center, post-market, clinical evaluation for subjects implanted with the SeaSpine Non-Cervical Pedicle Screw Systems

Eligibility criteria: Inclusion Criteria:

* Have undergone surgery
* Have undergone at least 12-months of postoperative follow-up

Exclusion Criteria:

* Any condition that the Investigator determines is unacceptable

Primary outcomes:
measure: The primary outcome for the study is device performance.
timeFrame: 12 months post-operative
Secondary outcomes:
measure: Evaluation of unanticipated adverse device effects (UADE)
timeFrame: 12-months
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Henry Ford
state: Michigan
city: New Albany
country: United States
facility: OrthoNeuro
state: Ohio
Study officials:
affiliation: SeaSpine, Inc.
name: Frank Vizesi, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05854277: Inception, Validation and Clinical Utility of a Score to Assess the Completeness of Caecal Visualisation
Official title: Inception, Validation and Clinical Utility of a Score to Assess the Completeness of Caecal Visualisation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyp
Colorectal Cancer
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: CCIS is a novel score, created specifically to evaluate the completeness of caecal visualized. It can be applied to a single or multiple images. To create the CCIS, the caecum was divided into eight parts: the appendiceal orifice (AO), the tri-radiate fold part 1 (TF-1), 2 (TF-2), 3 (TF-3) and four outer quadrants (OQ 1-4). The ileo-caecal valve (ICV) is a reference point but is not part of the score. The quadrant adjacent to the ICV is labelled OQ1. The three other quadrants are labelled clockwise from this quadrant. The tri-radiate folds are also labelled clockwise with TF1 representing the triangle side that is majority-contained within OQ1. TF2 and TF3 are then labelled clockwise from TF1.


Eligibility criteria: Inclusion Criteria:

* Endoscopists \>18 years old

Exclusion Criteria:

* Endoscopist not signing informed consent
* Any other medical doctor not connected with endoscopic practice

Primary outcomes:
measure: VALIDATE A NOVEL SCORE FOR THE COMPLETENESS OF CAECAL INTUBATION
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: UZ Gent
Study officials:
References:
Clinical trial NCT04250753: Assessment of Gait Parameters and Their Impact on Postoperative Recovery in Patients with Lumbar Spinal Stenosis
Official title: Assessment of Gait Parameters and Their Impact on Postoperative Recovery in Patients with Lumbar Spinal Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Spinal Stenosis
Keywords: neurogenic claudication
gait parameters
walking impairment
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 20
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 older than 18 years old with lumbar spinal stensois

Brief summary: The objective is to observe the evolution of walking parameters during the surgery process and find which of all calculated walking parameters represent the best indicators of functional disabilities and postoperative recovery for patient with lumbar spinal stenosis.


Eligibility criteria: Inclusion Criteria:

* Patients with lumbar spinal stenosis
* Presenting neurogenic claudication
* Waiting for a surgery (laminectomy, laminotomy, fusion)

Exclusion Criteria:

* Symptomatic hip or knee osteoarthritis

Primary outcomes:
measure: Change from baseline French-Canadian adaptation of Swiss Spinal Stenosis Questionnaires (FC-SSSQ)
timeFrame: Baseline, 6 weeks post-surgery, 6 months post-surgery
measure: Change from baseline Quality of life (EuroQol - 5D)
timeFrame: Baseline, 6 weeks post-surgery, 6 months post-surgery
measure: Change from baseline International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline, 6 weeks post-surgery, 6 months post-surgery
measure: Change from baseline Walking time
timeFrame: Baseline, 6 weeks post-surgery
measure: Change from baseline Walking speed
timeFrame: Baseline, 6 weeks post-surgery
measure: Change from baseline Gait cycle
timeFrame: Baseline, 6 weeks post-surgery
measure: Change from baseline Stride length
timeFrame: Baseline, 6 weeks post-surgery
Secondary outcomes:
measure: Change from baseline Swing Width
timeFrame: Baseline, 6 weeks post-surgery
measure: Change from baseline Minimal To Clearance
timeFrame: Baseline, 6 weeks post-surgery
Other outcomes:
Locations:
city: Trois-Rivieres
country: Canada
facility: Université du Québec à Trois-Rivières
state: Quebec
Study officials:
References:
Clinical trial NCT03306953: The Effect of Rectus Muscle Approximation at Cesarean Delivery on Pain Perceived After Operation
Official title: The Effect of Rectus Muscle Approximation at Cesarean Delivery on Postoperative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 280
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at Cesarean delivery.

Detailed description: This is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at Cesarean delivery. Postoperative pain will be assessed in 2 groups. Rectus muscle approximation will be done to the first group. The second group will be the control group.

Eligibility criteria: Inclusion Criteria:

* Women who will undergo first elective cesarean section
* Singleton pregnancy

Exclusion Criteria:

* Previous abdominal or pelvic surgery
* Medical or psychiatric disease
* Previous pelvic inflammatory disease
* Obesity
* Allergy to analgesics

Primary outcomes:
measure: Early pain score
timeFrame: 24 hours after cesarean section
Secondary outcomes:
measure: Late pain score
timeFrame: 48 hours after cesarean section
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
state: Greater Cairo
Study officials:
affiliation: Cairo University
name: Eman F Omran, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03108053: Results of Safety Guidewire Use in Ureteroscopic Stone Surgery
Official title: Results of a Prospective Randomized Trial of Safety Guidewire Use in Ureteroscopic Stone Surgery: to Use or Not to Use
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Stone
Keywords: urinary stones
semirigid ureteroscopy
guidewire
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Up-to-date, urology guidelines introduce safety guidewire (SGW) as an integral tool in ureteroscopy and recommended its routine use. However, the necessity of SGW placement in endourological procedures lack evidence and is being suggested as an expert opinion. Present study aimed to evaluate the use of SGW placement and its necessity in treatment of ureteral stones with semi-rigid ureteroscopy (s-URS).

For this purpose patients with ureteral stones are being stratified according to ureteral stone location and prospectively randomized into two groups' according to SGW usage or not in s-URS. Ureteroscopy and litotripsy is being done with a semi-rigid ureteroscope of 6.4/7.8 Fr (Olympus) and laser. Chi-square and student t-test were used for comparing data.


Eligibility criteria: Inclusion Criteria:

* Ureteral stone disease patients who would undergo ureteroscopy procedure

Exclusion Criteria:

* Patients who have a medical condition that makes randomisation not possible
* Patients in whose operations safety guidewire is regarded as a necessity
* Patients who refuse to participate

Primary outcomes:
measure: Stone free rates
timeFrame: Post operative 3 months (12 weeks after surgery)
Secondary outcomes:
measure: Operation duration of surgery
timeFrame: the duration of surgical procedure
measure: Late Complication rate
timeFrame: Post operative 3 months (12 weeks after surgery)
measure: Early Complication rate
timeFrame: Post operative 3 days (up to 3 days after surgery)
Other outcomes:
Locations:
city: Pendik
country: Turkey
facility: Marmara University School of Medicine
Study officials:
References:
Clinical trial NCT00378053: A Prospective Study of Radiation Exposure to Surgeons
Official title: A Prospective Study of Radiation Exposure to Surgeons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation Exposure
Keywords: Radiation
Exposure
Hand
Orthopaedic
Surgeons
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2006-09-19
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to measure the amount of radiation over a specific period of time that Orthopaedic Surgeons are exposed to while using the mini c-arm fluoroscopy machine.

Detailed description: The purpose of this study is to measure the amount of radiation over a specific period of time that Orthopaedic Surgeons are exposed to while using the mini c-arm fluoroscopy machine. The amount of radiation that the Surgeons will be exposed to will be recorded by a ring dosimeter located on the Surgeons' hand, and two badge dosimeters (one above the scrub collar, and one underneath a lead gown at waist level).

Eligibility criteria: This study will only enroll the Surgeons of the Vanderbilt Hand and Upper Extremity Center. There will be no inclusion/exclusion criteria for the type of surgery that will be monitored, nor the patients that are having surgery. If a mini c-arm fluoroscopy is used the amount of radiation received by the Surgeon's hand for that surgery will be monitored by a gas-sterilized radiation ring dosimeter. The amount of scatter radiation the Surgeon will be exposed to will be recorded by a badge dosimeter located on the Surgeon's scrub collar, and one badge dosimeter that will be located under the required lead gown worn by the Surgeon.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center- Vanderbilt Orthopaedic Institute
state: Tennessee
Study officials:
affiliation: VUMC
name: Donald H Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04694053: Fournier's Gangrene in Patient With Uncontrolled Type 2 Diabetes
Official title: Fournier's Gangrene as a Rare Complication in Patient With Uncontrolled Type 2 Diabetes Treated With Surgical Debridement: a Case Report and Literature Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fournier Gangrene
Keywords: Fournier's gangrene
Type 2 diabetes
surgical debridement
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 1
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A 66-year-old man, with a history of uncontrolled type 2 diabetes, obesity with BMI 38, chronic kidney failure and chronic heart failure, was admitted to the Emergency Department with a large area of necrosis involving the perineal and perianal regions.

Brief summary: A 66-year-old man, with a history of uncontrolled type 2 diabetes, obesity with BMI 38, chronic kidney failure and chronic heart failure, was admitted to the Emergency Department with a large area of necrosis involving the perineal and perianal regions.

Detailed description: Fournier's gangrene is a potentially fatal emergency condition, supported by an infection of perineal and perianal region, characterized by necrotizing fasciitis with a rapid spread to fascial planes. FG, usually due to compromised host, may be sustained by many microbial pathogens.

A 66-year-old man, with a history of uncontrolled type 2 diabetes, obesity with BMI 38, chronic kidney failure and chronic heart failure, was admitted to the Emergency Department with a large area of necrosis involving the perineal and perianal regions.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Fournier's Gangrene Insulin dependent diabetes (type 2)

Exclusion Criteria:

n/a

Primary outcomes:
measure: Number of Participants
timeFrame: From 3 November 2020 at 23 November 2020
measure: Fournier's gangrene evolution after treatment
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: University of Catania
Study officials:
affiliation: https://www.unict.it/
name: Daniele o Provenzano, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03873753: Relationship Between Oral Hygiene in Newborns and Candida Spp.
Official title: Relationship Between Oral Hygiene in Newborns and Candida Spp.: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Candidiasis, Oral
Keywords: Pediatric dentistry
Mouth, Edentulous
Lead sponsor: Faculty Sao Leopoldo Mandic Campinas
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 276
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Little is known regarding the effectiveness of neonatal oral hygiene and its relationship to colonization by Candida spp. in edentulous oral cavities. Thus, the objective of this study is to evaluate whether the oral hygiene of edentulous infants favors colonization by Candida spp. Newborns with up to 48 hours of life will randomly allocated to two groups. The mothers will instructed to clean the oral cavity with gauze and mineral water three times a day, in the test group, and not to clean, in the control group.


Eligibility criteria: Inclusion Criteria:

* A signed statement of informed consent
* Newborns up to 48 hours of life
* Exclusive breastfeeding
* Edentulous oral cavity

Exclusion Criteria:

* Any feeding other than breastfeeding
* Use of pacifier
* Digit sucking
* Systemic alterations

Primary outcomes:
measure: Change from number of Candida spp CFU/mm3
timeFrame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Secondary outcomes:
measure: Mean of patient's birth weight in the test group as assessed by questionnaire
timeFrame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
measure: Number of males in the test group as assessed by questionnaire
timeFrame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
measure: Number of cesarean delivery in the test group as assessed by questionnaire
timeFrame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
measure: Mean of patient's gestational week in the test group as assessed by questionnaire
timeFrame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
measure: Mean of patient's birth length in the test group as assessed by questionnaire
timeFrame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Faculty Sao Leopoldo Mandic
state: Sao Paulo
Study officials:
affiliation: Faculdade Sao Leopoldo Mandic, Campinas, SP, Brazil
name: Jose Carlos P Imparato, PhD
role: PRINCIPAL_INVESTIGATOR
References: