louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00539110: Differential Effects of Zolpidem Versus Ramelteon in Burned Children
Official title: Differential Effects of Zolpidem Versus Ramelteon on Nocturnal Sleep in Pediatric Burn Patients: A Prospective, Randomized Crossover Trial With Polysomnographic Recordings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep
Burns
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2007-10-04
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To examine sleep changes following therapeutic drug interventions designed to promote sleep.


Eligibility criteria: Inclusion Criteria:

* Burn injury \> 20% total body surface area
* Between 3 and 18 years of age
* \< 7 days from acute injury
* Written informed consent and HIPPA release signed

Exclusion Criteria:

* Suspected anoxic brain injury or head injury
* Hepatic or endocrine disease
* History of alcoholism or substance abuse
* Pre-existing neurological or primary psychiatric disorder
* Medical history of pre-existing sleep disorder or lactose deficiency
* Questionable survival (\<72 hrs) as decided by PI
* Receipt of drugs with known effects on sleep within 24 hrs of study entry
* No informed consent/HIPPA release

Primary outcomes:
measure: Polysomnography Data
timeFrame: 2 weeks postburn
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 2 weeks postburn
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Shriners Hospital for Children
state: Ohio
Study officials:
affiliation: Shriners Hospital for Children
name: Michele M Gottschlich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stockmann C, Spigarelli MG, Healy DP, Gottschlich MM, Kagan R, Balch AH, Sherwin C. Application of a method used to deconstruct a single dose pharmacokinetic profile from multiple dose data. Biopharm Drug Dispos. 2015 Sep;36(6):405-409. doi: 10.1002/bdd.1949. Epub 2015 Apr 21.
citation: Stockmann C, Gottschlich MM, Healy D, Khoury JC, Mayes T, Sherwin CM, Spigarelli MG, Kagan RJ. Relationship between zolpidem concentrations and sleep parameters in pediatric burn patients. J Burn Care Res. 2015 Jan-Feb;36(1):137-44. doi: 10.1097/BCR.0000000000000164.
citation: Stockmann C, Sherwin CM, Buterbaugh W, Spigarelli MG, Gottschlich MM, Healy D, Kagan RJ. Preliminary assessment of zolpidem pharmacokinetics in pediatric burn patients. Ther Drug Monit. 2014 Jun;36(3):295-301. doi: 10.1097/FTD.0000000000000017.
Clinical trial NCT03526510: Hypofractionated Boost vs Conventionally Fractionated Boost for Localized High Risk Prostate Cancer
Official title: Randomized Trial of Concomitant Hypofractionated IMRT Boost Versus Conventional Fractionated IMRT Boost for Localized High Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: High Risk Prostate Cancer
Radiotherapy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 178
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Trial
Primary purpose: TREATMENT

Brief summary: Randomized trial comparing 2 external beam radiotherapy fractionation schemes in patients with localized high risk prostate cancer. Primary endpoint is acute toxicity.

Detailed description: Patients enrolled onto this study will be randomized to one of the following treatment arms:

* Standard fractionation: Using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy.
* Hypofractionation: Using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost).

In addition, all patients receive 1.5- 3 years of androgen deprivation therapy.

Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained.
* Histologically confirmed diagnosis of adenocarcinoma of the prostate.
* T1-2 N0 M0, Gleason Score \<= 7, PSA 20 - 100
* T1-2 N0 M0, Gleason Score 8 - 10, PSA \<= 100
* T3 N0 M0, any Gleason Score, PSA \<= 100

Exclusion Criteria:

* Patients with unilateral or bilateral hip replacement.
* Patients with active collagen vascular disease.
* Patients with active inflammatory bowel disease.
* Patients with previous radiotherapy to the pelvis.
* Patients with ataxia telangiectasia.
* Patients with nodal or distant metastases

Primary outcomes:
measure: Acute Toxicity
timeFrame: within 3 months after starting radiotherapy
Secondary outcomes:
measure: Late Toxicity
timeFrame: beyond 3 months of starting radiotherapy
measure: Biochemical Control (Phoenix Definition)
timeFrame: at 5 years
measure: Overall Survival
timeFrame: at 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
Study officials:
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: Patrick Cheung, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01632410: The Autonomic Nervous System State and Response to Different Stimuli Among Patients Post Stroke: A Follow-up Study
Official title: The Cardiac Autonomic Nervous System State and Response to Reflective, Motor and Cognitive Stimuli Among Patients Post Stroke: A Follow-up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: autonomic nerve system
post stroke
focus of study: to describe the autonomic nerve system function post stroke
autonomic nervous system
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-07-03
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post hemispheral ischemic stroke cognitively intact.

Brief summary: The study describes the autonomic control system function in subjects post stroke in comparison with healthy subjects.

Aims: To describe the Autonomic hart rate control system function in post stroke subjects in different rehabilitation levels in comparison with healthy subjects.

To examine the reflective reaction of the autonomic control system as reflected in the heart rate variability to stimulations subjects in different rehabilitation levels in comparison with healthy subjects.

To examine the autonomic control system reaction as reflected in the heart rate variability to physical and cognitive action subjects in different rehabilitation levels in comparison with healthy subjects.

Detailed description: Subjects will be examined 3 times: a week 1 and 3 month post stroke. Control consist similar in description healthy subjects, will be examined once. Each test includes 24 hours Holter surveillance and an examine that include general check that reflects the autonomic reaction to different manipulation.

The examination description:

A. Prior to the examination subjects will be asked to fill the mRS, NIHSS forms.

B. Subjects will receive an examination that includes

* General neurological examination (strength, deep and superficial sensation, cognitive test and pain level.) C. Holter will be place for 24 hours. And autonomic examination test will be conducted
* Grip Test: emphases the sympathetic system.
* Breathing Test: emphases the parasympathetic system. D. Manipulation to examine the two sub systems. Each manipulation lasts1 minute.

Eligibility criteria: Inclusion Criteria:

* Post hemispheral ischemic stroke cognitively intact.

Exclusion Criteria:

* Subjects with severe visual or hearing impairments, stroke location brain steam.

Primary outcomes:
measure: RMSSD change
timeFrame: 3 month post stroke
Secondary outcomes:
measure: 6mwt
timeFrame: 3 month post stroke
measure: Patient's characteristics
timeFrame: 3 month post stroke
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Souraski Medical Center Neurology department
Study officials:
affiliation: Tel Aviv Suraski medical center
name: Nathan Borshtin, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00684710: Study Evaluating the Safety, Tolerability and Activity of One Dose of PAZ-417 Given to Healthy Japanese Subjects
Official title: Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of PAZ 417 Administered Orally to Healthy Young Japanese Male and Healthy Elderly Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Healthy
Keywords: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-28
Enrollment: 56
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will provide an initial assessment of the safety, tolerability, and pharmacokinetics (PK) of PAZ-417 after administration of ascending single oral doses to healthy young Japanese male and healthy elderly Japanese male subjects.


Eligibility criteria: Inclusion Criteria

1. Men aged 20 to 45 years inclusive (healthy young male subjects) and ≥65 years inclusive (healthy elderly male subjects)
2. Nonsmoker or smoker of fewer than 10 cigarettes per day.
3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria

1. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
2. Subjects who are identified as being at risk for hypercoagulability
3. Use of any investigational or prescription drug within 30 days before test article administration

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 3 months
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 3 months
Other outcomes:
Locations:
city: Kitashinagawa, Shinagawa-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00981110: Standard Versus Advanced Antimicrobial Dressing Containing Ionic Silver Following Colorectal Cancer Surgery
Official title: Surgical Sites Infections Following Colorectal Cancer Surgery. A Randomized Prospective Trial Comparing Standard and Advanced Antimicrobial Dressing Containing Ionic Silver.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: Surgical site infections (SSI)
Advanced antimicrobial dressing and clean surgery
Hydrofibre dressing
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2009-09-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 evaluate the efficacy of treatment with hydrofibre dressing in comparison with the efficacy of standard dressing in terms of prevalence of surgical site infections (SSI) in patients who underwent colorectal resection for malignancy.


Eligibility criteria: Inclusion Criteria:

* Patients bearing solid tumours who are candidate to open radical surgery for colorectal cancer (histology proven)
* Age 18-75
* Informed signed consent
* Performance Status 0-2 (according to ECOG score)
* Platelets \> 50.000/mm3
* Prothrombin Time (Quick) \> 60%
* White Blood Cells \> 2500/mm3
* Life Expectancy \> 3 months

Exclusion Criteria:

* Intestinal obstruction
* Severe intestinal bleeding requiring blood transfusion
* Age under 18 or over 75
* Severe hepatic failure (ascites, portal hypertension, jaundice or encephalopathy)
* Renal failure (hemodialysis, creatinin \> 2.5 mg/dL)
* Active infections
* Coagulopathy
* Inability to give an informed consent
* Known allergies to dressing components

Primary outcomes:
measure: The rate of patients with a Surgical site infection
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
city: Monza
country: Italy
facility: S. Gerardo Hospital
Study officials:
affiliation: European Institute of Oncology
name: Bruno Andreoni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: European Institute of Oncology
name: Roberto Biffi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: European Institute of Oncolgy
name: Emilio Bertani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biffi R, Fattori L, Bertani E, Radice D, Rotmensz N, Misitano P, Cenciarelli S, Chiappa A, Tadini L, Mancini M, Pesenti G, Andreoni B, Nespoli A. Surgical site infections following colorectal cancer surgery: a randomized prospective trial comparing common and advanced antimicrobial dressing containing ionic silver. World J Surg Oncol. 2012 May 23;10:94. doi: 10.1186/1477-7819-10-94.
Clinical trial NCT04787510: COVID-19 Disease and Coagulopathy: Assessment of Clotting Factor Levels in Patients With SARS-CoV-2 Infection
Official title: COVID-19 Disease and Coagulopathy: Assessment of Clotting Factor Levels in Patients With SARS-CoV-2 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-COV2 Infection
COVID-19 Disease
Hospitalized Patients
Lead sponsor: University Hospital, Ioannina
Sponsor class: OTHER
Collaborators: name: INTERNAL MEDICINE DEPARTMENT, 1ST WARD
First posted: 2021-03-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ALL ELIGIBLE PATIENTS AS DEFINED BY CRITERIA

Brief summary: Effect of Covid-19 disease in clotting factors levels in hospitalized patients

Detailed description: Effect of Covid-19 disease in clotting factors levels in hospitalized patients positive for sars-cov2 infection.

Association between clotting factors levels and disease severity,morbidity and mortality in these patients.

Effect of anticoagulant therapy in the clotting factors' levels in these patients

Eligibility criteria: Inclusion Criteria:

* AGE\> 18
* SINGED INFORMED CONSENT FORM
* POSITIVE PCR TEST FOR SARS-COV2 INFECTION
* FINDINGS IN CXR OR CT OF THE LUNGS CONSISTENT WITH INFECTION OF LOWER RESPIRATORY TRACT

Exclusion Criteria:

* AGE\<18
* DENIAL TO PROVIDE INFORMED CONSENT FORM
* HISTORY OF MALIGNANCY
* PRIOR USE OF ANTICOAGULANT THERAPY
* PRIOR USE OF STEROIDS LONGER THAN 14 DAYS
* LACTATION-PREGNANCY

Primary outcomes:
measure: EFFECT OF COVID-19 DISEASE IN CLOTTING FACTORS
timeFrame: 6 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Ioánnina
country: Greece
facility: University General Hospital of Ioannina
state: Epirus
Study officials:
affiliation: University Hospital, Ioannina
name: HARALAMPOS MILIONIS, PROFESSOR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02561910: Effectivity of Laparoscopic Inguinal Hernia Repair (TAPP) in Daily Clinical Practice - Early and Long-term Results
Official title: Effectivity of Laparoscopic Inguinal Hernia Repair (TAPP) in Daily Clinical Practice - Early and Long-term Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unilateral Inguinal Hernia With Gangrene and Obstruction
Keywords: Inguinal hernia repair
laparoscopic inguinal hernia repair
TAPP
Lead sponsor: Hernia Center Rottenburg
Sponsor class: OTHER
First posted: 2015-09-28
Enrollment: 952
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted for hernia surgery during a one year period (n=928) were operated exclusively in TAPP technique and were assigned to follow-up.

Brief summary: The effectiveness of laparoscopic inguinal hernia repair still remains unclear. During a one year period a total of 1208 inguinal hernias in 952 patients were consecutively operated using the laparoscopic technique by a total of 11 general surgeons in daily clinical routine.

Laparoscopic hernia repair in the TAPP technique seems to have the potential to become the standard procedure in inguinal hernia repair in future.

Detailed description: Objective:

Hernia repair is the most frequent operation in general surgery worldwide, but about 25 years after the advent of minimal invasive surgical techniques the effectiveness of laparoscopic inguinal hernia repair still remains unclear.

Methods:

All patients admitted to the hospital for surgery of an inguinal hernia during a one year period were prospectively documented and included in a follow-up study. The follow-up was performed at least 5 years after surgery and consisted of a clinical examination, ultrasound investigation and a questionnaire.

Eligibility criteria: Inclusion Criteria:

* All patients fit for general anesthesia and presenting an inguinal hernia.

Exclusion Criteria:

* Not fit for general anesthesia, young age (\>21 years), not wanting a mesh.

Primary outcomes:
measure: The primary outcome of the trial was recurrence of a hernia within five years after the repair.
timeFrame: 5 years
Secondary outcomes:
measure: The secondary outcome was chronic pain.
timeFrame: 5 years
Other outcomes:
Locations:
city: Rottenburg
country: Germany
facility: Hernia Center
Study officials:
affiliation: Hernia Center Rottenburg
name: Reinhard Bittner, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cavazzola LT, Rosen MJ. Laparoscopic versus open inguinal hernia repair. Surg Clin North Am. 2013 Oct;93(5):1269-79. doi: 10.1016/j.suc.2013.06.013.
Clinical trial NCT04981210: High Risk Screen of Childhood Late-onset Pompe Disease in Pediatric Outpatient Clinics
Official title: National Taiwan University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pompe Disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 1500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who are \>1 year and \< 18 year of age will be enrolled from outpatient clinics of pediatric neurology, pediatric orthopedics and pediatric rehabilitation in NTUH.

Brief summary: Establish of high-risk screening criteria to earlier identify possible childhood LOPD for early treatment and better prognosis. Therefore, validation of the high-risk screening criteria for childhood LOPD will be critical for identifying children of LOPD in Taiwan.


Eligibility criteria: Inclusion Criteria:

* Children who are \>1 year and \< 18 year of age from pediatric neurology, pediatric orthopedics and pediatric rehabilitation in NTUH

Exclusion Criteria:

* Children who have been diagnosed as specific neuromuscular disorders.

Primary outcomes:
measure: clinical signs/symptoms surveyed - Weakness in neck (No.1)
timeFrame: 2 years
measure: clinical signs/symptoms surveyed - Symptoms and signs of muscle weakness (No.2)
timeFrame: 2 years
measure: clinical signs/symptoms surveyed - Unable to speak clearly / keep slobbering (No.3)
timeFrame: 2 years
measure: clinical signs/symptoms surveyed - Scoliosis (No.4)
timeFrame: 2 years
measure: clinical signs/symptoms surveyed - Motor developmental delay (No.5)
timeFrame: 2 years
measure: clinical signs/symptoms surveyed - Persist diarrhea with unknown cause (No.6)
timeFrame: 2 years
measure: clinical signs/symptoms surveyed - Frequent respiratory infections (No.7)
timeFrame: 2 years
measure: clinical signs/symptoms surveyed - Morning headache (No.8)
timeFrame: 2 years
measure: clinical signs/symptoms surveyed - Urinary / Fecal incontinence (No.9)
timeFrame: 2 years
measure: dry blood sample (DBS) - GAA activity analysis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wen-Chin Weng
Study officials:
References:
Clinical trial NCT00284310: Follow-up of Patients After 4-row Arthrodesis or Proximal Row Carpectomy
Official title: Follow-up of Patients After 4-row Arthrodesis or Proximal Row Carpectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrist Surgery
Keywords: Wrist surgery: 4-corner arthrodesis or proximal row carpectomy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to follow-up on patients who underwent different types of wrist surgery: 4-row arthrodesis or proximal row carpectomy.


Eligibility criteria: Inclusion Criteria:

* All patients who underwent wrist surgery (4-row arthrodesis or proximal row carpectomy) between 1998 and 2004

Primary outcomes:
measure: Results of both types of wrist surgery
timeFrame: 5 to 10 years follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Rene Verdonk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: