louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00140283: Effectiveness of a Educational Intervention to Improve the Resolution Capacity of Primary Health Care Teams.
Official title: Phase IV Cluster Randomised Controlled Trial With 2 Parallel Groups, to Evaluate the Effectiveness of a Educational Intervention to Improve the Resolution Capacity.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Referral and Consultation
Keywords: Effectiveness
Educational intervention
Primary health care
Lead sponsor: Catalan Institute of Health
Sponsor class: OTHER_GOV
Collaborators: name: Fondo de Investigacion Sanitaria
First posted: 2005-09-01
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: There is a great variability in the different primary care teams referral rate. And variability means inappropriateness somewhere in the process of care. The most important determinants of the variability are the attitude and knowledge of the professional, the existence and availability of evidence, the resources available and the professionals practice style. To improve the knowledge of the professionals could be a way to decrease the variability. Because of this, we have the aim to determinate the effectiveness of an educational intervention to improve the primary care teams from the city of Barcelona referral rate.

Detailed description: The aim of our study is to determinate if an active educational intervention (interactive sessions discussing clinical cases plus the minimal intervention) reduces the professionals referral rate compared with the minimal intervention group (written adapted clinical practice guidelines and feedback about their referral rate compared with other primary care teams). It is a cluster-randomized controlled trial stratified by the percentage of reform and the referral rate. The subjects were primary care physicians of the 51 teams of Barcelona city attending 1.160.748 inhabitants.

Eligibility criteria: Inclusion Criteria:

* Primary care teams who agree to participate.
* Primary care teams attending adult population (older than 14).

Exclusion Criteria:

* Primary care teams where the intervention would be difficult to take place.
* Primary care teams where the referral rate is not available.
* Primary care teams with a percentage of reform lower than 40%.

Primary outcomes:
measure: Total number of referrals of the selected condition done by the primary care professionals to specialized consultants by 100 patients attended in 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Àmbit Barcelona (Catalan Institute of Health)
Study officials:
affiliation: Catalan Institute of Health
name: Josep Casajuana, Physician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184483: A Multi-site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair
Official title: Randomized Multi Site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: Surgery
Lichtenstein
Prolene Hernia System
Postoperative pain
Recurrence
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Sorlandet Hospital HF
name: Voss Sykehus
name: Haraldsplass Deaconess Hospital
name: Sykehuset Ostfold
First posted: 2005-09-16
Enrollment: 405
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation or Prolene Hernia System to repair their groin hernia. Follow up for three years with a total number of 4 clinical examinations. End point is postoperative pain and recurrences.


Eligibility criteria: Inclusion Criteria:

* Primary unilateral groin hernia in adult

Exclusion Criteria:

* recurrence warfarin treatment bilateral groin hernia

Primary outcomes:
measure: pain postoperative
timeFrame: 3 years
Secondary outcomes:
measure: Recurrences after groin hernia repair
timeFrame: 3 years
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Helge E Myrvold, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06668883: Novel Exhaled Breath Aerosol Collection Devices in Patients with Lower Respiratory Tract Infection - a Performance and Acceptability Study
Official title: Novel Exhaled Breath Aerosol Collection Devices in Patients with Lower Respiratory Tract Infection - a Performance and Acceptability Study (Acronym: AeroCAP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumonia
Lower Respiratory Tract Infection (LRTI)
Keywords: Respiratory Tract Infections
Pneumonia
Communicable Diseases
Infections
Breath
Lead sponsor: Avelo AG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Basel, Switzerland
First posted: 2024-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 18 and older admitted to the hospital with a clinical diagnosis of lower respiratory tract infection.

Brief summary: This study will assess the performance of two novel breath collection devices and their subsequent detection of respiratory pathogens compared to sputum samples in patients with lower respiratory tract infections.


Eligibility criteria: Inclusion Criteria:

* Able to understand the scope of the study and provide written informed consent
* Age \>18 years
* Speaking German
* Health status (assessed by study personnel at local site) well enough to use the breath collection devices
* Willing to provide all three study samples (sputum and two breath samples) required for the study
* Clinical diagnosis of a lower respiratory tract infection (LRTI) defined as:

  (i) New infiltrate (chest X-ray, ultrasound, or CT scan), and (ii) at least one clinical symptom suggestive of LRTI (fever ≥38°C, chills, new or worsening cough, new or worsening sputum production, new or worsening dyspnea, tachypnoea, chest pain)

Exclusion Criteria:

* Patients for whom the collection of all three study specimens within 24 hours of initiating antibiotic treatment is not feasible
* Patients with known cystic fibrosis or bronchiectasis
* Critically ill patients at the discretion of the investigator
* Patients on oxygen supplementation with a face mask, high-flow-oxygen, non-invasive or mechanical ventilation; oxygen supplementation via nasal cannula will be permitted.
* Patients with proven acute pulmonary embolism
* Patients with best supportive care
* Patients with severe hypoxemia (SpO2 \<88%) despite oxygen supplementation
* Hospitalization within the last 14 days prior to admission

Primary outcomes:
measure: Pathogen Concordance
timeFrame: 6 months
Secondary outcomes:
measure: Usability
timeFrame: 2 days after sample collection
measure: Expanded user feedback
timeFrame: 2 days after sample collection
measure: Rates of indeterminate breath results
timeFrame: 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
References:
Clinical trial NCT01247883: A Comparison Of A Single PF-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers
Official title: A Two Period, 2 Sequence Crossover To Establish The Relative Bioavailability Of A Single Pf-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
relative bioavailability
healthy volunteers
pharmacokinetics
solution
tablet
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Incyte Corporation
First posted: 2010-11-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the safety, tolerability and pharmacokinetics of PF-04634817 when respectively given orally as a single tablet dose and a single dose of a solution.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history and full physical examination.)
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
* Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication;
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
* Nursing females;
* Females of childbearing potential.

Primary outcomes:
measure: adverse events
timeFrame: 4 days
measure: Plasma Pharmacokinetics for both tablet and solution dosage forms.
timeFrame: 4 days
measure: The relative bioavailability (Frel) of PF-04634817 when administered as a tablet compared with a solution.
timeFrame: 4 days
measure: lab measurements
timeFrame: 4 days
measure: vitals/ECG parameters
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00367783: Safety, Toleration and Efficacy of CP-741,952 for the Treatment of Obesity
Official title: A 12-Week, Phase 2A, Randomized, Subject And Investigator Blind, Placebo-Controlled Trial To Evaluate The Effect Of CP-741,952 On Weight Loss In Otherwise Healthy Overweight And Obese Adult Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether CP-741,952 is effective in the treatment of obesity and to determine 12 week safety and toleration.

Detailed description: Following review of the preliminary data from completed study A7081004, the development program for CP-741,952 was terminated on 15 March 2007. Primary reasons for program termination included a lack of significant efficacy at all doses investigated and an increased incidence of mild to moderate elevations in serum transaminases, primarily alanine aminotransferase (ALT), and liver fat content, in treated compared to placebo subjects. A synopsis will be created and will include greater detail on these findings.

Eligibility criteria: Inclusion Criteria:

* BMI of 30-40 kg/m2

Exclusion Criteria:

* Women of childbearing potential

Primary outcomes:
measure: Weight Loss, toleration, safety
Secondary outcomes:
measure: Waist Circumference, serum lipids
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06446583: Preoperative Chewing Gum and Postoperative Nausea and Vomiting
Official title: Study on the Impact of Preoperative Chewing Gum on Postoperative Nausea and Vomiting in Robotic Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gynecologic Disease
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 92
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: General anesthesia for surgery can often lead to postoperative nausea and vomiting (PONV). Additionally, decreased or paralyzed bowel movements are among the most common complications following abdominal surgery, causing pain, abdominal distension, nausea, and vomiting, which can delay patient recovery and extend hospital stays. Therefore, meticulous perioperative management is crucial.

In recent years, efforts have been made to reduce the burden of surgery, decrease postoperative complications, and promote rapid rehabilitation for a quicker return to daily life. These efforts also aim to reduce healthcare costs by shortening hospital stays and optimizing resources. Various interventions, such as early feeding, early removal of nasogastric tubes, and physical therapy, have been trialed in clinical settings to prevent prolonged bowel inactivity and paralysis. However, due to limited clinical efficacy, these methods are not routinely used.

Recently, many researchers have reported the benefits of chewing gum in enhancing bowel motility and reducing PONV. However, there is limited research on the impact of chewing gum on PONV in robotic surgeries, which are considered less invasive compared to open or laparoscopic surgeries. Furthermore, there is particularly scarce research on the effects of preoperative gum chewing.


Eligibility criteria: Inclusion Criteria:

1. Adult patients aged 19 to under 70 years
2. Scheduled elective robotic surgery
3. American Society of Anesthesiologists (ASA) Physical Status Classification I or II

Exclusion Criteria:

1. Cases where robotic surgery was planned but suddenly converted to another type of surgery
2. Patients with a history of dental damage, dentures, loose or capped teeth, or other unstable dental conditions
3. Patients with a history of temporomandibular joint (TMJ) damage or surgery
4. Head and neck surgeries
5. Emergency surgeries
6. Refusal to participate in the study

Primary outcomes:
measure: nausea and vomiting
timeFrame: One hour after surgery, referring to the period spent in the post-anesthesia care unit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03227783: The Effect of Transcranial Direct Current Stimulation (tDCS) on Depression in PD
Official title: The Effect of Transcranial Direct Current Stimulation (tDCS) on Depression in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Parallel, Sham-controlled, single-blinded study
Primary purpose: TREATMENT

Brief summary: Depression is common in Parkinson's disease (PD), but the effective treatment is not established yet. tDCS is a non-invasive brain stimulation to modulate brain function. The tDCS on the depression in general population were already conducted, but not in PD. This study is to know whether transcranial direct current stimulation (tDCS) is effective for the treatment of depression in PD. Participant will be asked to visit three consecutive days for the non-invasive stimulation.


Eligibility criteria: Inclusion Criteria:

* UK Parkinson's disease brain bank criteria
* more than 19 years old
* Able to provide consent for the protocol
* Depression (based on DSM-IV criteria)

Exclusion Criteria:

* Dementia
* Unpredictable symptom fluctuations
* Contraindication to tDCS (i) irritations, cuts, lesions in the brain (ii) any preexisting unstable medical conditions, or conditions that may increase the risk of stimulation such as uncontrolled epilepsy (iii) history of severe cranial trauma with alteration of the cranial anatomy or metallic intracranial implants (iv) history of seizure
* Subjects without the capacity to give informed consent
* If participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as excessive fatigue, general frailty, or excessive apprehension

Primary outcomes:
measure: BDI score
timeFrame: (1) before the1st visit (within one month) (2) right after the 3rd tDCS (3) within one months after the 3rd tDCS
Secondary outcomes:
measure: HDRS score
timeFrame: (1) before the 1st visit (within one month) (2) right after 3rd tDCS, within 24 hours (3) within one months after the 3rd tDCS
measure: MADRS score
timeFrame: (1) before the 1st visit (within one month) (2) right after the 3rd tDCS, within 24 hours (3) within one months after 3rd tDCS
measure: resting state functional MRI
timeFrame: (1) before the 1st visit (within one month) (2) after the 3rd tDCS, within 24 hours (on the same day as the 3rd tDCS)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje university, Busan Paik Hospital
Study officials:
affiliation: Inje University
name: Sang Jin Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04860583: Nephrocalcinosis in Very Low Birth Weight Infants
Official title: Nephrocalcinosis in Very Low Birth Weight Infants: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant; Premature, Light-For-Dates
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 265
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants born at the Croix-Rousse Hospital, Lyon, France between 01/01/2012 and 31/12/2017 with a gestational age \<= 32 weeks and/or a birthweight \<=1500g. Infants with a diagnosed kidney malformation are excluded.

Brief summary: Extremely premature children benefit from specific follow-up that requires high nutritional intake and the use of specific therapies that expose them to the risk of nephrocalcinosis. Other identified risk factors are extreme prematurity and intrauterine growth restriction.

The incidence of nephrocalcinosis in very premature infants is unclear, ranging from 7 to 64%. Most studies are observational and only few case-control studies can properly analyse the risk factors for nephrocalcinosis in significant populations that include only preterm infants.

This nephrocalcinosis of prematurity regresses spontaneously in more than half of the cases, but has been associated with a risk of long-term complications: impaired renal function, high blood pressure, etc. This is an aggravating factor in the context of prematurity, which has been associated with an increased risk of renal impairment and hypertension in childhood and adulthood.

For all these reasons, nutritional intakes and therapeutics are monitored very closely and a renal ultrasound is routinely performed at discharge at 35 weeks of corrected gestational age in all children who are born at a gestational age ≤ 32 weeks and/or birth weight ≤ 1500 g.


Eligibility criteria: Inclusion Criteria:

* Newborns with a gestational age \<= 32 weeks and/or birthweight \<=1500g

Exclusion Criteria:

* Newborns with kidney malformation

Primary outcomes:
measure: Prevalence of nephrocalcinosis
timeFrame: At week 35 of corrected gestational age
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03087383: Identification of Genetic Polymorphisms Related to Propofol Requirement and Recovery Through Genome-wide Association Study (GWAS) in Total Intravenous Anesthesia for Clipping of Unruptured Cerebral Aneurysm in Korean Population
Official title: Identification of Genetic Polymorphisms Related to Propofol Requirement and Recovery Through Genome-wide Association Study (GWAS) in Total Intravenous Anesthesia for Clipping of Unruptured Cerebral Aneurysm in Korean Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Unruptured Cerebral Aneurysm
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Korean adult population undergoing propofol based total intravenous anesthesia for clipping of unruptured cerebral aneurysm

Brief summary: In neurosurgical anesthesia, propofol based total intravenous anesthesia (TIVA) is frequently used due to brain relaxation and less effect on electrophysiologic monitoring. Response to propofol can vary between individuals and be associated with clinical factors including age and weight, and genetic polymorphism. Because the importance of rapid recovery in neurosurgery with long operation time is emphasized recently, the choice and dose adjustment of anesthetics should be determined according to clinical and genetic factors. Recently, researches about genetic variations have been performed with single nucleotide polymorphism (SNP). The aim of this study is to find SNPs associated with propofol recovery and response through genome-wide association study (GWAS) in Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm.


Eligibility criteria: Inclusion Criteria:

* Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm

Exclusion Criteria:

* Patients not able to read, or understand the consent form
* Ethnicity, other than Korean population
* Patients refusal
* Patients not to perform total intravenous anesthesia
* Patients currently taking psychiatric medication

Primary outcomes:
measure: Time of eye opening after stopping propofol infusion
timeFrame: Within one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
citation: Iohom G, Ni Chonghaile M, O'Brien JK, Cunningham AJ, Fitzgerald DF, Shields DC. An investigation of potential genetic determinants of propofol requirements and recovery from anaesthesia. Eur J Anaesthesiol. 2007 Nov;24(11):912-9. doi: 10.1017/S0265021507000476. Epub 2007 Jun 7.