louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00940290: Practice Guidelines Grading Systems
Official title: Different Grading Systems to Grade Evidence and Recommendations in Clinical Practice Guidelines: Does it Influence the Clinicians´ Behavior?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decision Making
Keywords: practice guideline as topic
decision making
evidence based medicine
Lead sponsor: Instituto Tecnologico y de Estudios Superiores de Monterey
Sponsor class: OTHER
First posted: 2009-07-16
Enrollment: 216
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Clinical practice guidelines (CPG) are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. They are developed to give a recommendation based on the best evidence available. Through a randomized trial, the investigators intend to provide information about which of the four grading systems most used today to grade evidence and recommendations in CPGs, could change physician´s behavior towards a common clinical situation in daily practice.

Detailed description: Clinical practice guidelines (CPG) are used by professional and consumer organizations who are demanding more rigorous processes to ensure that health decisions are well informed by the best available research evidence. More than 60 different grading systems are used today to grade evidence and recommendations in CPGs. The investigators aimed to provide information about which of the four most common grading systems used today (GRADE, SIGN, NICE and CEBM-Oxford) could change physician´s behavior when reading a clinical recommendation in a CPG. The investigators will randomize 216 pediatricians and pediatricians in training into four groups (one for each grading system) to read a clinical case and to make a decision before reading the CPG statement graded with any of the four grading systems. After that they will re-consider their answer and post a new one based on the graded recommendation. The investigators will measure change in their decision and among groups.

Eligibility criteria: Inclusion Criteria:

* Pediatricians and residents in pediatrics

Exclusion Criteria:

* Less than six months in clinical practice

Primary outcomes:
measure: Change in Behavior in Physicians Attitude Towards a Decision to Give a Medication
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Escuela de Medicina y Biotecnologia del ITESM
state: NL
Study officials:
affiliation: Instituto Tecnologico y de Estudios Superiores de Monterey
name: Carlos A Cuello-Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cuello Garcia CA, Pacheco Alvarado KP, Perez Gaxiola G. Grading recommendations in clinical practice guidelines: randomised experimental evaluation of four different systems. Arch Dis Child. 2011 Aug;96(8):723-8. doi: 10.1136/adc.2010.199307. Epub 2011 May 19.
Clinical trial NCT04763590: Cognitive Behavioral Therapy for Mechanical Ventilation Wean
Official title: Cognitive Behavioral Therapy for Mechanical Ventilation Wean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Cognitive Behavioral Therapy
Mechanical Ventilation Complication
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 2
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to use CBT strategies in assisting patients hospitalized in intensive care units in ventilation wean through a case series of 2 patients.

Detailed description: Approximately a third of patients in intensive care are mechanically ventilated. The current weaning standard of care leaves much to be desired in both patient anxiety and time to wean. Cognitive behavioral therapy (CBT) is the gold standard treatment for anxiety. The purpose of this study is to use CBT strategies in assisting patients hospitalized in intensive care units in ventilation wean through a case series of 2 patients.

Eligibility criteria: Inclusion Criteria:

* Receiving mechanical ventilation and Failed 3 spontaneous breathing trials

Exclusion Criteria:

* Delirium

Primary outcomes:
measure: Respiratory Anxiety
timeFrame: 6 weeks
measure: Panic Symptoms
timeFrame: 6 weeks
measure: Generalized Anxiety
timeFrame: 6 weeks
measure: Depression
timeFrame: 6 weeks
measure: Time spent on tracheostomy-collar (off mechanical ventilation)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
citation: Cohen JN, Gopal A, Roberts KJ, Anderson E, Siegel AM. Ventilator-Dependent Patients Successfully Weaned With Cognitive-Behavioral Therapy: A Case Series. Psychosomatics. 2019 Nov-Dec;60(6):612-619. doi: 10.1016/j.psym.2019.02.003. Epub 2019 Feb 12. No abstract available.
Clinical trial NCT02171390: Endothelial Dysfunction, Inflammation and Insulin Resistance in Congenital Hypogonadism and Effect of Testosteron Replacement Therapy
Official title: Phase 4 Study That Evaluates the Presence of Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Subjects With Hypogonadotrophic Hypogonadism and Effects of Two Different Testosterone Replacement Regiments on These Parameters.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypogonadotrophic Hypogonadism
Keywords: Hypogonadism
Endothelial dysfunction
Insulin resistance
Inflammation
Testosterone replacement therapy
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 130
Sex: MALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study searched for answers to two questions

1. Is there endothelial dysfunction, inflammation and insulin resistance in patients with congenital hypogonadotropic hypogonadism?
2. What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?


Eligibility criteria: Inclusion Criteria:

* Men
* Treatment naive
* Hypogonadotrophic hypogonadism

Exclusion Criteria:

* Previous history of androgen replacement
* Chronic metabolic disorders

Primary outcomes:
measure: The alterations in the measures for endothelial functions
timeFrame: 6 months
measure: The alterations in the measures of inflammation
timeFrame: 6 months
measure: The alterations in the measures of insulin resistance
timeFrame: 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine Department of Endocrinology and Metabolism
state: NonUS
Study officials:
References:
Clinical trial NCT07002190: The Effect of Education Given Before Port Catheter Infusion on Infusion Related Symptoms
Official title: The Effect of Education Given Before Port Catheter Infusion on Infusion Related Symptoms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Port-A-Cath
Keywords: Pain
Anxiety
Education
Nursing
Port catheter
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Pain, anxiety, anxiety and changes in vital signs are observed in patients during needle insertion into the port catheter.Patients and their relatives should be informed by nurses to eliminate these problems and to provide more comfortable infusion to patients.However, studies on the care process for the symptoms that occur before port catheter infusion are limited in the literature.The thesis study planned for this purpose will be carried out to determine the effect of the training given before port catheter infusion on infusion-related symptoms.The research will be conducted as pretest-posttest, randomised controlled.Oncology-Hematology Services and Chemotherapy Unit of Karadeniz Technical University Farabi Hospital.The sample of the study will be determined by simple randomisation method and 64 patient will be included in the study.The data of the study will be collected by Patient Descriptive Information Form, Visual Analogue Scale and State and Trait Anxiety Scale, Vital Signs Follow-up Chart.


Eligibility criteria: Inclusion Criteria:

* Having a port catheter
* The patient has no previous experience with a port catheter,
* The patient will receive an infusion from a port catheter for the first time,
* The patient's age range is between 18-70,
* The patient is literate,
* Volunteering to participate in the study,
* The patient will receive training from the training material for the first time.

Exclusion Criteria:

* Those with communication, hearing and vision problems,
* Those with any psychiatric disorder,
* Those who used any analgesic medication at least 8 hours before

Primary outcomes:
measure: Patient Identifying Information Form
timeFrame: 1 day
Secondary outcomes:
measure: State and Trait Anxiety Scale
timeFrame: 2 day
measure: Symptom chart
timeFrame: 2 day
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
affiliation: Karadeniz Technical University
name: Şule Bıyık Bayram, Assoc. Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06913790: Evaluation of Central Corneal Thickness in Patients With Vernal Keratoconjunctivitis Using Topical Steroids
Official title: Evaluation of Central Corneal Thickness in Patients With Vernal Keratoconjunctivitis Using Topical Steroids
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vernal Keratoconjunctivitis
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 34
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective observational cohort study aims to assess changes in central corneal thickness (CCT) in vernal keratoconjunctivitis (VKC) patients using topical steroids. Data will be collected from tertiary care hospitals such as Al-Mustafa eye hospital and Jinnah Hospital, Lahore

Brief summary: This prospective observational cohort study aims to assess changes in central corneal thickness (CCT) in vernal keratoconjunctivitis (VKC) patients using topical steroids. Data will be collected from tertiary care hospitals such as Al-Mustafa eye hospital and Jinnah Hospital, Lahore.

Detailed description: A total of 34 participants, including an adjustment for a 10% dropout rate, will be recruited using purposive sampling. The study will last six months. Eligible participants (aged 5-25 years) must have a confirmed VKC diagnosis and be on topical steroids, with exclusions for prior ocular surgery, systemic steroid use, and contact lens wear. Baseline assessments will include demographic data, VKC severity, and CCT measurements via pachymetry and optical coherence tomography. Follow-up evaluations at one and three months will track CCT changes. A paired t-test will compare baseline and follow-up measurements. This study will help understand the impact of topical steroids on CCT in VKC patients.

Eligibility criteria: Inclusion Criteria:

* Young adults aged between 5-25 years
* Confirmed diagnosis of VKC
* Currently prescribe topical steroid e.g, dexamethasone, prednisolone
* No prior history of corneal surgery or trauma
* Willing to attend follow-up visits and comply with the treatment protocol.

Exclusion Criteria:

* History of ocular surgery or trauma
* Presence of other corneal pathologies (e.g., Keratoconus)
* Systemic immunosuppressant use or history of systemic steroid use in the past 06 months
* Use of other medications that could influence corneal thickness e.g, antiglaucoma drugs
* Contact lens use within 1 month prior to the study
* Severe dry eye or another ocular surface disease"

Primary outcomes:
measure: Slit Lamp Test
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Al Mustafa eye hospital lahore
state: Punjab
Study officials:
References:
Clinical trial NCT01531790: A Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced Non Small Cell Lung Cancer Patients
Official title: A Phase I Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced NSCLC Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Keywords: Endostar
Carboplatin
Pemetrexed
NSCLC
Phase I
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-02-13
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics of continuous Endostar intravenous infusion combined with pemetrexed and carboplatin in advanced non small cell lung cancer (NSCLC) patients.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of inoperable stage IIIB/IV non-squamous NSCLC
* At least one measurable lesion (RECIST criteria)
* Life expectancy \> 3 months
* ECOG performance status 0-2
* Adequate hematologic function: WBC ≥ 3.0×109 /L，ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L
* Adequate renal, hepatic and coagulation function
* Written informed consent

Exclusion Criteria:

* With uncontrollable malignant pleural effusion or ascites
* Thoracic or abdominal surgery within 28 days prior to study entry
* History of cerebral stroke or TIA within 6 months prior to study entry
* With uncontrollable hypertension, hypertensive emergency or hypertensive encephalopathy
* Arrhythmia in need of antiarrhythmic treatment, history of angina pectoris, myocardial infarction, myocardial ischemia or congestive heart failure (\> NYHA class II)
* With serious infection (\> NCI CTC grade 2)
* Gastrointestinal perforation, fistula formation, and/or intra-abdominal abscess within 6 months prior to study entry
* Symptomatic brain metastases
* Patient who has epilepsy
* History of HIV infection or chronic hepatitis B or C
* Allergic to any of the study drugs
* Pregnant or lactating women

Primary outcomes:
measure: Dose Limiting Toxicity
timeFrame: up to 21 days
Secondary outcomes:
measure: Objective Response Rate
timeFrame: up to 6 cycles
measure: Disease Control Rate
timeFrame: up to 6 cycles
measure: Progression-free Survival
timeFrame: up to 2 years
measure: Overall Survival
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00195390: Study Investigating Administration of Prevenar for Post-Marketing Surveillance
Official title: Investigation of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine) Administration for Post-Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Infections
Keywords: Vaccine
heptavalent pneumococcal conjugate vaccine
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic, secondary and tertiary medical centers

Brief summary: The purpose of this study is to identify the following problems and questions with respect to the safety of Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevenar, during the post-marketing period in Korea, as required by Korea Food and Drug Administration (KFDA) regulations.

1. Adverse reactions (especially serious adverse reactions)
2. Incidences of adverse reactions under routine vaccine use
3. Factors that may affect the safety of the vaccine


Eligibility criteria: Inclusion Criteria:

* Infants and children aged 6 weeks to 9 years, provided the conditions pertaining to contraindications, warnings, precautions, and interactions stated in the package insert do not apply.

Exclusion Criteria:

* Hypersensitivity to latex or to any component of the vaccine, including diphtheria toxoid
* Suffering from a current or recent febrile illness.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00119990: Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis
Official title: Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis; the Effect of Different Dialysates
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peritoneal Dialysis
Keywords: vasopressin
icodextrin
cardiac output
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2005-07-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: During peritoneal dialysis, water is removed from the body. This sometimes occurs at rates of up to 500 ml/h. During shifts with dialysate with high glucose content, an increase in blood pressure has been described. The effect upon central hemodynamics is unknown. The researchers are investigating the effects of low and high glucose dialysate and icodextrin on cardiac output, stroke volume, pulse rate and blood pressure. The researchers have hypothesized that the effects seen are induced by vasopressin.


Eligibility criteria: Inclusion Criteria:

* Peritoneal dialysis patients

Exclusion Criteria:

* Insulin dependent diabetes mellitus
* AV-fistula, cardial arrhythmia persistence, or severe cardiac and lung disease
* Recent infectious disease
* Severe psychiatric disease
* Hypersensitivity to icodextrin

Primary outcomes:
measure: Changes in cardiac hemodynamics. (Cardiac Output, stroke volume, pulse rate, blood pressure and total peripheral resistance)
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Deparment of Renal Medicine, Skejby Hospital
Study officials:
affiliation: Department of Renal Medicine C, Skejby Hospital, Denmark
name: Per Ivarsen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boon D, Bos WJ, van Montfrans GA, Krediet RT. Acute effects of peritoneal dialysis on hemodynamics. Perit Dial Int. 2001 Mar-Apr;21(2):166-71.
Clinical trial NCT05505890: Effects of Postoperative Analgesic Modalities on Plasma Creatine Phosphokinase(CPK) Levels After Knee Artroplasty
Official title: Effects of Postoperative Analgesic Modalities on Plasma Creatine Phosphokinase(CPK) Levels After Knee Artroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myotoxicity
Keywords: bupivacaine, myotoxicity, creatine phosphokinase,SFIPB
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing knee artroplasty surgery of ASA status 1-3. aged between 18-75years.

Brief summary: Regional anesthesia and analgesia technics are widely and securely used during orthopedic surgery. Interfascial plane blocks are the latest used ones for analgesia. There are studies in literature indicating that bupivacaine cause myotoxicity. We aimed to examine plasma CPK(creatine phosphokinase) levels to see whether myotoxicity occurs or not after suprainguinal fascial plane block is applied to patients undergoing knee artroplasty surgery.

Detailed description: During 2 months period all elligible patients undergoing knee artoplasty surgery will be included in the study. Different postoperative analgesic modalities will be used according to the anesthesists experience. During routine blood sample tests plasma CPK levels will be tested 3 times of all patients.(preoperative, postoperative 6th hour, postoperative 24th hour) this data will be recorded for 2 months. After this period of time data will be analysed and patients will be grouped according to the analgesic modalities used.

Eligibility criteria: Inclusion Criteria:

* ASA 1-3
* knee artoplasty patients
* under spinal anesthesia

Exclusion Criteria:

* local anesthetic allergies
* myopathies
* coagulopathies
* Obstructive sleep apne syndrome
* hearth diseases
* liver diseases
* kidney diseases
* thyroid-parathyriod dieseas
* hiperlipidemias using Statins(HMG-CoA reductase inhibitors)
* pregnancy

Primary outcomes:
measure: CPK levels
timeFrame: at postoperative 24th hour
Secondary outcomes:
measure: Number of patients requesting rescue analgesics
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University
Study officials:
affiliation: Samsun University
name: Serkan Tulgar
role: STUDY_CHAIR
References:
citation: Rakhi V, Kaushal S, Singh S. Measurement of bupivacaine induced myotoxicity in interfascial plane blocks: A randomised controlled trial. Indian J Anaesth. 2021 Dec;65(12):886-891. doi: 10.4103/ija.ija_848_21. Epub 2021 Dec 22.