louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04589767: Validation Study of the "CORNELL ASSESSMENT PEDIATRIC DELIRIUM" (CAPD)" Scale in Italian Language
Official title: Validation Study of the "CORNELL ASSESSMENT PEDIATRIC DELIRIUM" (CAPD)" Scale in Italian Language
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: delirium
monitoring
Lead sponsor: Azienda Ospedaliera di Padova
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 70
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children admitted in PICU

Brief summary: 70 children (based on the inclusion and exclusion criteria described above) admitted in PICU will be daily assessed by two nurses (inter-evaluator agreement) using the Italian version of CAPD scale administered twice at a distance of 2 minutes (intra-evaluator agreement).

Detailed description: The psychometric validation study will take place in the PICU of the Hospital of Padua. CAPD translation and cultural adaptation was developed within the Pediatric Cardiac Surgery Intensive Care Unit of the Federico II Polyclinic.

In this study we aim to perform the psychometric validation. 70 children (based on the inclusion and exclusion criteria described above) admitted in PICU will be daily assessed by two nurses (inter-evaluator agreement) using the Italian version of CAPD scale administered twice at a distance of 2 minutes (intra-evaluator agreement).

The score will be recorded in a data collection card, all the cards will be collected and then analyzed.

Eligibility criteria: Inclusion Criteria:

* PICU admission
* Comfort Behavioral Score \> 11

Exclusion Criteria:

* use of neuromuscular blocking agents at the moment of CAPD evaluation
* Comfort Behavioral Score \< 11

Primary outcomes:
measure: inter-evaluator agreement
timeFrame: 1 hour during PICU stay
measure: intra-evaluator agreement
timeFrame: 2 minutes during PICU stay
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: PICU University Hospital of Padova
Study officials:
affiliation: University Hospital Padova
name: angela amigoni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02743767: Frequency of Airway Complications During General Anaesthesia After Introducing Five Handling Adaptations
Official title: Frequency of Airway Complications During General Anaesthesia After Introducing Five Handling Adaptations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Complications
Keywords: Airway management
General anaesthesia
Critical incidents
Complications
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 7455
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if five simple adaptations in airway management of patients undergoing general anaesthesia can reduce minor and major airway complications.

After a first detection of causes of airway complications during general anaesthesia investigators initiated five different interventions in airway management, which were: immediate bag-valve mask ventilation after administering of muscle relaxants, optimized preoxygenation, introducing of a preinterventional checklist, increased usage of video laryngoscopy and immediate change of provider in case of failed intubation.

In a second phase of this observational study investigators want to evaluate if these five interventions can reduce minor and major airway complications during general anaesthesia.

Additionally, investigators want to record how many critical incidents (CIRS) occur during this observational period and how many of them will be reported by the involved stuff.


Eligibility criteria: Inclusion Criteria:

* Must receive a general anaesthesia with any form of airway management

Exclusion Criteria:

* Anaesthesia without airway management
* Patients who do not give or who withdraw general consent

Primary outcomes:
measure: Reduction of airway complications after introducing five treatment adaptations
timeFrame: 2 months
Secondary outcomes:
measure: Postoperative side effects after routinely general anaesthesia
timeFrame: 2 months
measure: Frequency of reporting critical incident (CIRS)
timeFrame: 2 months
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: University Hospital
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Robert Greif, MD MME FERC
role: STUDY_CHAIR
References:
citation: Pedersen TH, Ueltschi F, Hornshaw T, Greif R, Theiler L, Huber M, Kleine-Brueggeney M. Optimisation of airway management strategies: a prospective before-and-after study on events related to airway management. Br J Anaesth. 2021 Nov;127(5):798-806. doi: 10.1016/j.bja.2021.07.030. Epub 2021 Sep 15.
Clinical trial NCT04683367: Follow-up of Symptomless Inguinal and Ventral Hernias
Official title: 15-year Follow-up of Laparoscopically Diagnosed Occult Inguinal and Ventral Hernias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Hernia, Ventral
Laparoscopy
Keywords: inguinal hernia
ventral hernia
laparoscopic diagnosis
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The orifices of all inguinal and ventral (including Spigelian) hernias were carefully recorded at the beginning of laparoscopy (n=201) of other reason (cholecystectomy, fundoplication) in 2003-5. The patients with occult hernias (n=43) were followed-up 15 years to find out what percentage of hernias would become symptomatic.

Detailed description: This was a prospective laparoscopic study of 201 consecutive adult patients operated in 2003-5. There were 133 females and 68 males with a mean age 53 ± 14 years. The index laparoscopic operation included 104 cholecystectomies, 55 fundoplications, 36 diagnostic, 5 appendectomies and one insertion of peritoneal catheter. A careful clinical examination of the groin and ventral region was performed on everybody and all patients with clinical hernias were excluded. Laparoscopic exploration of the inguinal region was considered safe and did not greatly increase the operative time. All patients were informed that hernial orifices would be explored during laparoscopy, and a written consent was asked prior to surgery. Permission to repair large hernias (\> 1 cm) was also obtained before laparoscopy.

The patients were followed-up 15 years to find out, what percentage of occult, symptomless inguinal and ventral hernias were later operated because of harmfull symptoms.

Eligibility criteria: Inclusion Criteria:

* occult inguinal or ventral hernia diagnosed in laparoscopic surgery

Exclusion Criteria:

* clinically diagnosed inguinal or ventral hernia

Primary outcomes:
measure: number of operated hernia
timeFrame: 15 years
Secondary outcomes:
measure: number of symptomatic hernia
timeFrame: 15 years
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: department of Surgery, Kuopio Univ Hospital
name: Hannu EK Paajanen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00346567: Backup With Combivir or Single Dose (SD) Truvada in Order to Avoid Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Resistance After SD Nevirapine for the Prevention of Mother-to-child Transmission (PMTCT)
Official title: Clinical Trial: Backup With Combivir (AZT/3TC) or Single Dose (sd) Truvada (FTC/TDF) in Order to Avoid NNRTI Resistance After sd Nevirapine for the Prevention of Mother-to-child Transmission (MTCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: mother-to-child-transmission
PMTCT
HIV
resistance
NNRTI
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2006-06-30
Enrollment: 566
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to find short course alternatives to single dose (sd)nevirapine for the prevention of mother-to-child HIV-transmission with the same or better degree of transmission protection than sd nevirapine but with less NNRTI resistance development.

Detailed description: Randomised open study comparing Zidovudine from 28 weeks gestation, single dose Nevirapine + 1 week of Combivir with Zidovudine from 28 weeks gestation, single dose Nevirapine + single dose of Truvada for the mothers during birth. In both arms the infants will receive one dose of nevirapine within the first days after births as well as 7 to 28 days Zidovudine. N = 450. The study will be conducted at Ngamiani and Makorora Health Centres and Bombo Regional Hospital in Tanga, Tanzania as a cooperation between Rigshospitalet, Denmark, University of Copenhagen and National Institute of Medical Research, Tanzania.

Eligibility criteria: Inclusion Criteria:

* HIV infected, antiretroviral naive, not fulfilling national Tanzanian criteria for HAART treatment, giving informed consent, consenting to homevisit-follow-up in case of no-show for scheduled hospital visit.

Exclusion Criteria:

* CD4 less than 350 x10(6)/L, suffering from systemic diseases in need of medical treatment e.g. TB, renal or liver failure etc.
* Creatinin higher than 1,5 mg/dL, Alanine aminotransferase above 140 U/L

Primary outcomes:
measure: frequency of mother-to-child HIV transmission
timeFrame: 6 weeks post partum
measure: frequency of NNRTI resistance development
timeFrame: 6 weeks post partum
Secondary outcomes:
measure: Comparison of p24 antigen to HIV RNA for treatment induced changes in viremia
timeFrame: Delivery, day 7, day 42 and month 9 post partum
measure: Comparison of p24 antigen ability to detect viremia for the various subtypes A,C & D
timeFrame: Delivery, Day 7, Day 42 post partum, mother, Day 42 and Day 90 post partum child
Other outcomes:
Locations:
city: Tanga
country: Tanzania
facility: Bombo Regional Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Terese L Katzenstein, MD Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01978067: Quality of Life and Sexual Function of Vaginal Operation in The Treatment Of Previous Cesarean Scar Defect
Official title: Safety ,Validity and Quality of (Sexual)Life of Vaginal Operation in The Treatment Of Previous Cesarean Scar Defect
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Sexual Activity
Keywords: Uterine Scar From Previous Cesarean Delivery
previous caesarean scar deficiency
transvaginal resection
quality of life
sexual activity
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 patients diagnosed PCSD scheduled for vaginal operation in The First Affiliated Hospital between December 2013 and December 2015

Brief summary: The aim of this study is to further demonstrate the safety , validity and quality of (sexual)life of vaginal operation for previous cesarean scar defect resection.

Detailed description: collect all the patients'clinical information,use two questionnaire (the HRQoL and FSFI)to estimate patients' general healthy and sexual function before surgery and postoperation in 1 month,3 months and 6 months

Eligibility criteria: Inclusion Criteria:

* preoperative diagnosed as PCSD
* hemodynamic stability

Exclusion Criteria:

* irregular menstrual cycle
* using IUD
* complicating other disease also causing vaginal bleeding,such as endometrial polyp,submucous myoma and functional uterine bleeding.

Primary outcomes:
measure: The safety of transvaginal resection of caesarean scar deficiency in the treatment of PCSD
timeFrame: one week
Secondary outcomes:
measure: the effectiveness of transvaginal resection of caesarean scar deficiency in the treatment of PCSD.
timeFrame: one year
Other outcomes:
measure: the result of transvaginal resection of caesarean scar deficiency in affecting quality of (sex)life.
timeFrame: one year
Locations:
city: GuangZhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Chen Shu-Qin, M.D&PhD
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Yao Shu-Zhong, M.D&Ph.D
role: STUDY_CHAIR
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Fan Li, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01174667: Massage of the Low Back Muscles Assessed With Ultrasound Scanning
Official title: Effect of Fascial Release on Connective Tissue Structure in Human Subjects With Chronic Low Back Pain as Determined by Ultrasound Imaging: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Myofascial Pain Syndrome
Keywords: Myofascial pain
Trigger points
Lead sponsor: Anglo-European College of Chiropractic
Sponsor class: OTHER
First posted: 2010-08-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to use diagnostic ultrasound to compare the thickness of soft tissues in the low back in a group of patients with chronic low back pain treated with massage to a control group of non-treated patients.

It is hypothesized that on average, soft tissue thickness in the lumbar region will change in the group receiving massage compared to the control group.

Detailed description: A specialized form of massage designed to reduce fascial restrictions will be compared to a no-treatment control group based on a change in thickness of the lumbodorsal fascia as determined by ultrasound imaging.

Eligibility criteria: Inclusion Criteria:

* History of chronic low back pain far at least 3 months
* Able to read and write English
* Between 18-64 years of age

Exclusion Criteria:

* Prior lumbar surgery
* Infected or broken skin over the lumbodorsal fascia
* Major structural spinal deformity
* Specific cause of low back pain, such as tumor, infection, fracture
* Bleeding disorders or use of anticoagulant medications
* Pregnancy
* Litigation for low back pain
* Systemic infection

Primary outcomes:
measure: Thickness of lumbodorsal fascia determined by ultrasound imaging
timeFrame: An average of 5 minutes from the the end of first treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Anglo-European College of Chiropractic
name: Hugh Gemmell, DC, EdD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06190067: Azacitidine Plus PD-1 Therapy for R/R Hodgkin Lymphoma
Official title: Azacitidine Plus PD-1 Therapy for Relapsed/Refractory Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Relapsed Classic Hodgkin Lymphoma
Refractory Classic Hodgkin Lymphoma
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this phase 2 trial is to test the safety and efficacy of azacitidine when given together with PD-1 therapy in treating patients with relapsed/refractory classic Hodgkin lymphoma.

Detailed description: The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with PD-1 therapy in classic relapsed/refractory Hodgkin lymphoma.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed Hodgkin Lymphoma according World Health Organization (WHO) classification.
* Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
* Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted.
* Patient is willing and able to adhere to the study visit schedule and other protocol requirements.
* Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below).
* Meet the following lab criteria: Absolute Neutrophil Count (ANC) ≥ 1,5 x 10\^9/L (≥ 1 x 10\^9/L if bone marrow (BM) involvement by lymphoma); Platelet ≥ 75 x 10\^9/L (≥ 50 x 10\^9/L if BM involvement by lymphoma); Hemoglobin ≥ 8 g/dL.
* Anticipated life expectancy at least 3 months.

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
* Pregnant or lactating women.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 1 year
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 2 year
measure: Progression Free Survival (PFS)
timeFrame: 18 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Navy General Hospital
state: Beijing
Study officials:
affiliation: Navy General Hospital, Beijing
name: Liren Qian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03092167: Physical Training in Patients With Idiopathic Inflammatory Myopathies
Official title: Physical Training in Patients With Idiopathic Inflammatory Myopathies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Inflammatory Myopathies
Physical Activity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 15 idiopathic inflammatory myopathies submmited to physical exercises 15 idiopathic inflammatory myopathies not submmited to physcial exercises 10 healthy individuals
Primary purpose: BASIC_SCIENCE

Brief summary: Physical training may improve physical capacity and health parameters in various systemic autoimmune diseases, including idiopathic inflammatory myopathies. Therefore, the present study will assess the role of an exercise training program in patients with idiopathic inflammatory myopathies.

Detailed description: To assess the impact of 12-weeks of physical training in patients with idiopathic inflammatory myopathies.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of DM / PM according to the criteria of Bohan and Peter (1975)
* Both genders and age ≥ 18 years
* Use of prednisone ≤ 0.5 mg/kg/day in the last three months. The dose of prednisone will be kept fixed throughout the study
* Physically inactive

Exclusion Criteria:

* Disease relapsing
* Neoplasia associated-myositis
* Overlapping myositis
* Use of lipid-lowering drugs
* Smoking
* Diabetes mellitus

Primary outcomes:
measure: Cardiopulmonary test
timeFrame: 12 weeks
Secondary outcomes:
measure: Serum cytokines
timeFrame: 12 weeks
measure: Strength muscle tests
timeFrame: 12 weeks
measure: Muscle biopsies
timeFrame: 12 weeks
measure: Functional muscle tests
timeFrame: 12 weeks
measure: Myositis Disease Activity Assessment Tool
timeFrame: 12 weeks
measure: Muscle enzymes
timeFrame: 12 weeks
measure: Health Assessment Questionnaire
timeFrame: 12 weeks
measure: Manual Muscle Testing
timeFrame: 12 weeks
measure: Patient/Parent Global Activity
timeFrame: 12 weeks
measure: Physician Global Activity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Samuel Katsuyuki Shinjo
Study officials:
affiliation: Universidade de Sao Paulo - Rheumatology Division
name: Samuel K Shinjo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borges IBP, de Oliveira DS, Marie SKN, Lenario AM, Oba-Shinjo SM, Shinjo SK. Exercise Training Attenuates Ubiquitin-Proteasome Pathway and Increases the Genes Related to Autophagy on the Skeletal Muscle of Patients With Inflammatory Myopathies. J Clin Rheumatol. 2021 Sep 1;27(6S):S224-S231. doi: 10.1097/RHU.0000000000001721.
Clinical trial NCT00765167: Training and Calibration of Dental Examiners
Official title: Training and Calibration of Dental Examiners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Plaque
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Training and calibration of dental examiners


Eligibility criteria: Inclusion Criteria:

* Male or female volunteers 18-65 years of age
* Good general health
* Must sign informed consent form
* Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

1. Subjects unable or unwilling to sign the informed consent form.
2. Medical condition which requires pre-medication prior to dental visits/procedures
3. Moderate or advanced periodontal disease or heavy dental tartar (calculus).
4. 2 or more decayed untreated dental sites at screening.
5. Other disease of the hard or soft oral tissues.
6. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
7. Use of medications that can affect salivary flow (e.g. anticholinergics, adrenergics, antihistamines, vasoconstrictors or decongestants).
8. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
9. Pregnant or nursing women.
10. Participation in any other clinical study within 1 week prior to enrollment into this study.
11. Allergy to chlorhexidine
12. Use of tobacco products
13. Subjects who must receive dental treatment during the study dates.
14. Current use of Antibiotics for any purpose.
15. Presence of an orthodontic appliance.
16. History of allergy to common dentifrice ingredients.
17. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Primary outcomes:
measure: Dental plaque
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: UMDNJ Dental School
state: New Jersey
Study officials:
name: Michael Deasy, DDS
role: PRINCIPAL_INVESTIGATOR
References: