louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00457535: Study of the Relationship Between rHuEPO Dose, Serum ADPN, and Mortality in Patients Beginning HD
Official title: Recombinant Human Erythropoietin Dose, Serum Adiponectin, and All-Cause Mortality in Patients Beginning Hemodialysis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Renal Dialysis
Keywords: recombinant human erythropoietin
adiponectin
mortality
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
Collaborators: name: Shitoro Clinic
name: Fujinomiya City Hospital
name: Iwata City Hospital
name: Seirei Mikatabara General Hospital
name: Seirei Hamamatsu General Hospital
name: Hamana Clinic
name: Tadokoro Clinic
name: Makoto Clinic
name: Maruyama Memorial General Hospital
name: Sun-Sanaru Clinic
First posted: 2007-04-06
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Responsiveness of recombinant human erythropoietin (rHuEPO) is known to be related with body fatness in hemodialysis (HD) patients. Adiponectin (ADPN) is inversely associated with body fat mass, and in healthy subjects, low ADPN is a predictor of mortality. Recently, higher rHuEPO dose itself is demonstrated to be associated with poor prognosis. So, in this study, we prospectively examined the relationship between rHuEPO dose, serum ADPN, and mortality in patients beginning HD.

Detailed description: We selected 85 patients (51 men/34 women, age; 64±15 years) who survived for more than 3 months after the start of HD. After determining initial rHuEPO dosage, we followed the patients for 3 years, and examined an association between rHuEPO dose, serum ADPN, and all-cause mortality.

We could follow totally 74 out of 85 patients for 3 years; 59 patients were survived, but 15 patients expired. Dosage of rHuEPO was significantly and negatively correlated with body mass index (BMI) (r=-0.44, p\<0.01) and positively with serum ADPN (r=0.29, p\<0.02), but not with leptin. Cox-hazards regression analysis adjusted by age, sex and underlying kidney disease revealed that rHuEPO dose and serum ADPN, as well as nutritional parameter such as protein catabolic rate became significant determinants of 3-year mortality. There was a 12.7% risk increase for 10U/kg/week increase in rHuEPO dose and 1.3% increase for 1µg/ml increment of serum ADPN for the 3-year of follow-up.

Eligibility criteria: Inclusion Criteria:

* patients who had first started hemodialysis therapy from August 2000 to May 2001 in 11 dialysis centers in Shizuoka prefecture area.

Exclusion Criteria:

* nothing particular

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: First Department of Medicine, Hamamatsu University School of Medicine
name: Naro Ohashi, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04562935: Long-term Consequences of Admission for Pediatric Intensive Care Before One Year of Age
Official title: Long-term Consequences of Admission for Pediatric Intensive Care Before One Year of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurodevelopmental Disorders
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 330
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents

Brief summary: This study is a retrospective cohort study. The PICU children will include all surviving children who were admitted to the PICU of Copenhagen University Hospital between 1st of January 2002 and 31st of December 2016.

A link to a questionnaire including the Strengths-and-Difficulties parental questionnaire evaluating neurodevelopmental- and behavioral impartment as well as question on current impairments and health, will be sent to parents. For the children aged between 11 and 17 years an additional self-rated questionnaire will be provided.

Detailed description: This study is a retrospective cohort study. The PICU children will include all surviving children who were admitted to the pediatric intensive care section of the Department of Neonatology of Copenhagen University Hospital between 1st of January 2002 and 31st of December 2016.

The Strengths-and-Difficulties parental questionnaire evaluating neurodevelopmental- and behavioral impartment is web-based an hosted on a safe hospital server. The link will be sent to the universat digital post-box that all Danish citizens use for contact to the public authorities. For the children aged between 11 and 17 years an additional self-rated questionnaire will be provided. Furthermore, parents will answer questions on chronic illness, motor and sensory handicap, and special pedagogical support in day care institutions and school.

Eligibility criteria: Inclusion Criteria:

* Admitted to the PICU of Copenhagen University Hospital between 1st January 2002 to 31st of December 2016
* Age of admission \> 28 days, if born \> 37 + 0 or have reached the gestational age of \> 40 weeks if the child is premature.
* Needing ≥ 2 days ventilator support during the PICU stay
* Valid civil registration number

Exlusion criteria:

- Death before follow-up

Primary outcomes:
measure: Total difficulty score of the SDQ questionnaire
timeFrame: 2 to 18 years of age
Secondary outcomes:
measure: Rate of cerebral palsy
timeFrame: 2 to 18 years of age
Other outcomes:
measure: Rate of learning disability
timeFrame: 2 to 18 years of age
measure: Rate of chronic disease
timeFrame: 2-18 years
measure: Rate of visual impairment
timeFrame: 2-18 years
measure: Rate of hearing impairment
timeFrame: 2-18 years
Locations:
city: Copenhagen
country: Denmark
facility: Gorm Greisen
Study officials:
affiliation: Rigshospitalet, Denmark
name: gorm greisen, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06215235: Implementation of Bright Light Therapy ID
Official title: Alleviation of Depressive Symptoms in People With Intellectual Disabilities
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depressive Symptoms
Keywords: Depressive symptoms
Bright light therapy
Implementation
Intellectual disability
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients are adult with an intellectual disability who have received BLT for their depressive symptoms.
* Staff are adults (without ID) who work for one of the two care organizations and who are involved in the implementation or prescription or facilitation of BLT.

Brief summary: Many adults with intellectual disabilities (ID) have depressive symptoms, which negatively impact their quality of life. A lot of of the non-medicinal forms of treatment are not or hardly suitable for people with ID. Bright light therapy (BLT) seems to be a good option. Earlier research has shown that BLT is applicable in this group and seems promising in terms of reducing depressive symptoms, without serious side effects.

In part 1 of this project we investigate the implementation of BLT at Amarant. We will take the lessons learned into part 2 of this project: the implementation of BLT at Abrona. We will evaluate this process and the outcomes.


Eligibility criteria: Inclusion Criteria:

* Involved in the implementation of BLT (staff) OR
* Involved in the prescription or application of BLT (staff/relatives) OR
* receiving BLT for their depressive symptoms (patients with ID)
* 18 years or older
* informed consent

Exclusion Criteria:

* n/a

Primary outcomes:
measure: acceptability
timeFrame: three times during study, 3-4 months in between
measure: appropriateness
timeFrame: three times during study, 3-4 months in between
measure: feasibility of the intervention
timeFrame: three times during study, 3-4 months in between
measure: fidelity
timeFrame: three times during study, 3-4 months in between
measure: strategies
timeFrame: three times during study, 3-4 months in between
measure: Determinants
timeFrame: three times during study, 3-4 months in between
Secondary outcomes:
measure: Depressive symptoms
timeFrame: 1 year
measure: Behaviour
timeFrame: 1 year
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: ErasmusMC
Study officials:
References:
Clinical trial NCT05055635: Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5)
Official title: ReRad III. Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Anal Cancer
Recurrent Anal Cancer
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 55
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: This protocol aims to determine toxicity and efficacy of re-irradiation for patients with recurrences from anal cancers with dose-escalated pencil beam proton therapy either pre-operative for marginally resectable recurrences or as a definitive treatment strategy (un-resectable, operation declined etc.). The over-all aim is to improve local tumor control with acceptable side effects.


Eligibility criteria: Inclusion Criteria:

* Recurrent anal cancer
* Bioptically verified (squamous cell carcinoma)
* Available dose plan from primary radiotherapy
* Previous RT (\>30Gy EQD2)
* Evaluated in MDT-conferences (Herlev, Aarhus)
* Age\>18 years
* PS 0-2
* Adequate organ function
* Written informed consent

Exclusion Criteria:

* Distant metastases deemed without curative intended treatment options (PET-CT)
* Unable to undergo MRI, PET-CT
* Inability to attend full course radiotherapy and follow up in the outpatient clinic.

Primary outcomes:
measure: Local control
timeFrame: 12 months
Secondary outcomes:
measure: Local re-recurrence
timeFrame: 6 and 24 months
measure: Progression free survival
timeFrame: 3-5 year FU
measure: Overall survival
timeFrame: 3-5 year FU
measure: Pathological evaluation of R0, R1 or R2 resection
timeFrame: 6 months
measure: Toxicity
timeFrame: up to 6 weeks, 1 year, 3 year
measure: Quality of life assessment
timeFrame: up to 6 weeks, 1 year, 3 year
measure: Quality of life assessment
timeFrame: up to 6 weeks, 1 year, 3 year
measure: Quality of life assessment
timeFrame: up to 6 weeks, 1 year, 3 year
measure: Quality of life assessment
timeFrame: up to 6 weeks, 1 year, 3 year
measure: Translational research
timeFrame: baseline, end of therapy, 1 year
measure: Summed radiotherapy dose volume to organs at risk and correlation to toxicities
timeFrame: up to 6 weeks, 1 year, 3 year
measure: To investigate 30-day surgical overall morbidity
timeFrame: 30-day
measure: To investigate 6-month surgical site morbidity
timeFrame: 6 months
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Danish Centre for Particle Therapy
state: Aarhus
Study officials:
References:
Clinical trial NCT00599235: Sildenafil and Exercise Capacity in Hypertension
Official title: Effects of the Selective Phosphodiesterase Type 5 Inhibitor Sildenafil Citrate on Exercise Capacity and Vascular Function in Hypertensive Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Exercise capacity
PDE5 inhibitors
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Hypertension (persistently elevated blood pressure) is a major risk factor for heart disease and stroke. Hypertensive individuals show a reduced exercise capacity, which is present from a very early stage and contributes to their increased cardiovascular risk. Sildenafil belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, and it works by enhancing the effects of nitric oxide, a substance that dilates blood vessels and increases blood flow. We hypothesize that sildenafil, because of its effect on nitric oxide and blood flow, will improve exercise capacity in hypertensive patients. Therefore, the main aim of the study is to investigate the effects of PDE5 inhibition on exercise capacity and vascular function in hypertension, and to compare these effects in hypertensive patients and healthy controls.


Eligibility criteria: Inclusion Criteria:

* Male (age range: 18 - 70 years)
* Appropriate blood pressure range
* Hypertensive - Systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg
* Controls - Systolic BP \<140 mmHg and diastolic BP \<90mmHg
* Written informed consent

Exclusion Criteria:

* Female
* History of coronary artery, cerebrovascular or peripheral vascular disease within the last 6 months
* Total cholesterol \>6.5 mmol/L
* Current alcohol abuse
* Diabetes mellitus
* Asthma
* Taking any anti-hypertensive, vasoactive or endothelial function modifying drugs which cannot be withdrawn for the purpose of the study
* ECG evidence of clinically significant arrhythmia or cardiac ischaemia
* Clinically significant abnormality on screening blood test
* Contraindication to strenuous exercise
* Current involvement in other research projects
* Other clinically relevant conditions
* Lack of written informed consent

Primary outcomes:
measure: Peak oxygen uptake (VO2) during exercise
timeFrame: 1 week of treatment
Secondary outcomes:
measure: Exercise systolic blood pressure
timeFrame: Maximal exercise
measure: Pulse wave velocity and pulse wave analysis
timeFrame: Before and after maximal exercise
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh - Western General Hospital
Study officials:
affiliation: University of Edinburgh
name: Teresa M Attinà, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Edinburgh
name: David J Webb, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05621135: Validity and Reliability of the Sitting Assessment Scale in Cerebral Palsy
Official title: Validity and Reliability of the Sitting Assessment Scale in Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Validity
Lead sponsor: Gaziantep Islam Science and Technology University
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 34
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cerebral Palsy will be participate the study between the ages of 2 and 18 years.

Brief summary: The Sitting Assessment Scale is a valid and reliable scale that evaluates sitting balance in Cerebral Palsy (CP). The validity and reliability study of the scale has been done, but it has not been adapted to Turkish language. The aim of this study is to adapt the Sitting Evaluation Scale, which evaluates sitting balance in Cerebral Palsy, into Turkish and to examine the validity and reliability of the Turkish version of the scale.

Detailed description: Cerebral Palsy will be participate the study between the ages of 2 and 18 years. Children's classified with GMFCS and MACS.

Evaluation will be applied to the volunteer participants after the translation steps of the Sitting Evaluation Assessment are completed. The validity of the scale will be examined in terms of construct validity and content validity. All evaluations will be performed in the clinic with the specialist physiotherapist.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Cerebral Palsy voluntary participation,
* Age between 2-18 years

Exclusion Criteria:

* Not voluntary to participate in the research,
* Botox in the last 6 months,
* Hip or spine surgeries in the last 6 months

Primary outcomes:
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: At Baseline
measure: Manuel ability classification system (MACS)
timeFrame: At Baseline
measure: Gross Motor Function Measure-88
timeFrame: At Baseline
measure: Trunk Control Measurement Scale
timeFrame: At Baseline
measure: Sitting Assessment Scale
timeFrame: At Baseline and 2 weeks after the baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep
Study officials:
affiliation: Gaziantep Islam Science and Technology University
name: Demet GÖZAÇAN KARABULUT
role: STUDY_DIRECTOR
References:
Clinical trial NCT02892435: Prevena™ Incision Management System vs Conventional Management for Wound Healing
Official title: Wound Healing After Dirty/Contaminated Emergency Abdominal Surgery: Prevena™ Incision Management System vs Conventional Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Wound Healing
Prevena
Dirty Abdominal Surgery
Contaminated Abdominal Surgery
Emergency Abdominal Surgery
Negative-Pressure Wound Therapy
Lead sponsor: Ospedale Misericordia e Dolce
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison in abdominal wound healing after contaminated or dirty surgery with incisional negative pressure wound therapy versus standard dressing.

Detailed description: All patients submitted to contaminated or dirty abdominal surgery have more risk of surgical site infections. The investigators intend to randomize this kind of patients and comparison wound healing after dressed with incisional negative pressure wound therapy or standard dressing.

In the study group INPWT (Prevena) is positioned immediately next surgery and dressed for six days. Every patients will be medicate in sixth, ninth, fifteenth and thirtieth day after surgery and will be valued wound healing with a scale score.

Moreover for each patient it will be assessed risk developing wound complications through possum score and comorbidities.

Eligibility criteria: Inclusion Criteria:

* abdominal surgery
* open surgery
* contaminated or dirty surgery

Exclusion Criteria:

* not abdominal surgery
* mininvasive surgery
* clean surgery

Primary outcomes:
measure: Surgical Site Infection (SSI) reduction
timeFrame: 7 months
Secondary outcomes:
measure: Surgical Site Infection (SSI) and risk factors as diabetis, obesity and cancer
timeFrame: 2 years
Other outcomes:
Locations:
city: Prato
country: Italy
facility: Misericordia e Dolce Hospital
state: Po
Study officials:
affiliation: Ospedale Santo Stefano Prato
name: Francesco Feroci, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05978635: Goal Directed Numeric Coaching as a Means of Preoxygenation
Official title: Goal Directed Numeric Coaching as a Means of Preoxygenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-oxygenation
Keywords: Pre-oxygenation, vital capacity breaths
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Once an adequate seal with consistent end tidal carbon dioxide on capnography is achieved, time starts. Patients are divided into two groups:

Group A: Anesthesia provider encourages patient to breathe deeply by intermittently stating "take as deep a breath as you can". No goal directed numeric coaching is given. End point is 80% expired oxygen. The time it takes to achieve this end point and breath volumes are recorded.

Group B: Anesthesia provider gives goal directed numeric coaching. For example, if the initial tidal volume achieved by the patient is 500mL, the provider states, "that was a 500mL breath, now try to achieve a 1000mL breath". The numeric goal should continue to increase above the patient's actual tidal volume (volume moved in and out of lungs during normal, quiet breathing) until an end point of 80% is reached. The time it takes to achieve this end point and breath volumes are recorded.
Primary purpose: TREATMENT

Brief summary: Pre-oxygenation is an anesthetic technique that allows for extended apneic (suspension of breathing) time prior to attempted endotracheal intubation. A common method to achieve adequate pre-oxygenation is having a patient take four vital capacity breaths of 100% oxygen in thirty seconds. This study seeks to determine if goal directed numeric coaching can lead to more accurate vital capacities during this technique.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists Physical Status 1 and 2
* nonsmokers
* primary English speaking
* undergoing elective surgery with planned endotracheal intubation

Exclusion Criteria:

-

Primary outcomes:
measure: Vital capacity breaths measured in milliliters
timeFrame: Pre oxygenation period prior to induction of general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03753035: Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children
Official title: Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Children, Only
Quality of Life
Seizures
Patient Compliance
Keywords: epilepsy
children
seizures
patient compliance
quality of life
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-11-26
Enrollment: 75
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all epileptic children at Nancy Children Hospital

Brief summary: There is little epidemiological data in the literature on the therapeutic compliance of epileptic children. Yet it is a fundamental issue in the therapeutic education and balance of this pathology. To obtain more epidemiological precision on the observance of epileptic children and to propose, according to the factors involved, the improvement of practices (therapeutic education ..). Propose an evaluation of the quality of life of their children by a suitable self-questionnaire.


Eligibility criteria: Inclusion Criteria:

* • Child aged 5 to 17

  * Child who has received complete information on the organization of the research and who has not objected to his participation and the exploitation of his data
  * Holder (s) of the parental authority present (s) having received the complete information on the organization of the research and not being opposed to the participation and the exploitation of the data of his child
  * Epileptic child
  * Follow-up at the neuro pediatric department of CHRU Nancy

Exclusion Criteria:

* epileptic encephalopathy
* Multiply handicapped child

Primary outcomes:
measure: Mean compliance
timeFrame: 6 months
Secondary outcomes:
measure: Compliance score of the modified Modified Morisky Medication Adherence Scales 8
timeFrame: 6 months
measure: quality of life of epileptic children
timeFrame: 6 months
measure: syndromes
timeFrame: 6 months
Other outcomes:
Locations:
city: Nancy
country: France
facility: GIRARD
state: Lorraine
Study officials:
References: