louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02533297: Developing Standards Skill According to the Learning Curves
Official title: Developing Standards for Skill Performance Times in Nursing Clinical Education Program According to Learning Curve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Student
Keywords: standardization,
performance clinical skills
nursing
learning curve
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the current study was to develop a criterion in terms of the number of sessions required to achieve mastery in DCS based on the learning curve assessment in real clinical situation.


Eligibility criteria: Inclusion Criteria:

* Nursing and midwifery students in Mashhad.
* Before the relevant skills in teaching nursing for the theoretical and practical training
* Employment as student work , etc., is not nursing .

Exclusion Criteria:

* Skills into the clinical environment is not done , or a maximum of three times ( contact skills intravenous line , dry dressing , intramuscular injection ) has done .

Defects or diseases that cause skills to do independent problem , no . ( At the discretion of the instructor )

No sign student proficiency , skills required in this section or elsewhere has done .

Student of psychological ( lack of acute stress , etc.) is ready to perform skills . ( At the discretion of the instructor )

Primary outcomes:
measure: level of expertise nursing student
timeFrame: in training course (4month follow up)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Miri K, Malekzade J, Davoudi N, Mazloum S. How many Times of Intramuscular Injec-tion and Intravenous Catheter Insertion is Essential for Learning? Developing Standards according to the Learning Curves. Iranian Journal of Medical Education. 2013; 13 (6) :457-469
Clinical trial NCT06716697: the Impact of Physical and Mental Fatigue on Balance
Official title: the Impact of Physical and Mental Fatigue on Balance
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Balance
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All young adults that work or have study load that affect their fatigue level

Brief summary: Mental and physical Fatigue and overall fatigue will be collected based on Fatigue assessment scale while balance data will be obtained by recording mobile sensors in X, Y and Z directions when mobile placed on COG of the participants.


Eligibility criteria: Inclusion Criteria:

* patients from 18 to 24 years old

Exclusion Criteria:

* free of any mental disorders or major health issues in last year

Primary outcomes:
measure: Balance
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kafrelsheikh
country: Egypt
facility: Faculy of Physical Therapy Kafrelshaikh University
Study officials:
affiliation: faculty of physical therapy
name: Ahmed Torad Torad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00745797: Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy
Official title: Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy：A Multi-center Randomized Phase ⅢTrial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Brain Metastases
Keywords: nonsmall cell lung cancer
brain metastasis
prophylactic cranial irradiation
Lead sponsor: Chinese Society of Lung Cancer
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 1. Patients with confirmed advanced NSCLC and any response to 3-6 cycles of chemotherapy, were randomized to receive PCI (30 Gy/10fr) or no PCI.
2. The primary endpoint was the cumulative incidence of symptomatic brain metastases (BM) .
3. The study was sized to detect a hazard ratio of 0.37 with 80% power and 2-sided 5% significance (60 events, 206 patients).

Detailed description: 1. Prophylactic cranial irradiation (PCI) significantly reduces the risk of brain metastases (BM) and improves survival in patients with extensive disease small cell lung cancer after a response to chemotherapy .
2. PCI has also demonstrated to reduce or delay the incidence of CNS failure in non small cell lung cancer patients after primary therapy.
3. But its impact on overall and disease free survival is uncertain.

Eligibility criteria: Inclusion Criteria:

1. Patients were required to have histologically or cytologically documented NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy
2. No previous history of radiotherapy and surgery of brain
3. Agree to radiotherapy
4. age \> 18 and \<75 years
5. ECOG performance status 1 or less
6. Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB\>=80g /DL) functions
7. Have provided informed consent

Exclusion Criteria:

1. Seizure cannot be controled by the drugs
2. Combined with other disease of the brain such as tumour or infarction
3. Hypersensitivity to MR enhancer

Primary outcomes:
measure: The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) .
timeFrame: 2.5years
Secondary outcomes:
measure: 1year survival,overall survival,incidence rate of radioactive brain injured
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Lung Cancer Research Institute & Cancer Center of Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Chinese Society of Lung Cancer
name: WU YI LONG, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02088697: A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-17
Enrollment: 50
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and sertraline Tablet in Japanese healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers aged 20 to 40 years.
* Have a body mass index (BMI) between 18.5 and 25.0 kg/m2 and a weight of at least 50 kg.

Exclusion Criteria:

* History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study.
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically significant abnormalities in the physical examination, clinical laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of Sertraline
timeFrame: predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose
Secondary outcomes:
measure: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Observable Concentration at Time t (AUCt) for Sertraline
timeFrame: predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka Pharmacology Clinical research Hospital
Study officials:
References:
Clinical trial NCT02320097: A Study of the Impact of Head Position on Foot Pressure in Stance
Official title: A Study of the Impact of Head Position on Foot Pressure in Stance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Study the Impact of Head Position
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-12-19
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: When examining a subject in quiet stance from the side, the leg segment is usually seen to be oriented upwards and forwards by about 5°; the knee may be flexed by a few degrees, the shoulders are behind the great trochanter and the head is held forwards. The forward head position moves the center of gravity forwards and thus may increase pressure under the forefoot. Conversely, moving the head backwards should be accompanied by an increase in pressure under the heel and thus decreased pressure under the forefoot.

The study's objective is to study the influence of alignment of the head with the back (i.e. a rearward head position) and head rotation on the foot pressure distribution (measured using a foot pressure platform).


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 30
* Social security coverage
* Ability to understand the study's objectives, procedures and risks and to provide informed, written consent

Exclusion Criteria:

* Past or concomitant infectious or cancerous diseases of the spine
* Vertebral osteosynthesis
* Acute neck or arm pain
* Limb trauma in the previous 12 months
* Acute leg pain
* Neuropathic disease or the sequelae of neuropathic disease of the legs
* Myasthenia gravis
* Central nervous system disorders
* Inner ear problems
* Subjects under legal guardianship
* Known pregnancy
* Simultaneous participation in another biomedical research study of a drug or medical device.

Primary outcomes:
measure: The foot pressure in g/cm2 and the anteroposterior pressure distribution, measured using a foot pressure platform.
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Mutter Catherine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nisand M, Callens C, Destieux C, Dyer JO, Chanson JB, Sauleau E, Mutter C. Baropodometric quantification and implications of muscle coactivation in the lower limbs caused by head movement: A prospective study. J Bodyw Mov Ther. 2020 Jan;24(1):228-234. doi: 10.1016/j.jbmt.2019.05.014. Epub 2019 May 15.
Clinical trial NCT00571597: Short Term Outcomes From Minimally Invasive Surgery for the Treatment of Atrial Fibrillation
Official title: Prospective Analysis of the Wolf Minimaze Procedure for Treatment of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: surgery
ablation
radiofrequency
minimaze
transtelephonic monitoring
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2007-12-12
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible subjects will be male or females age 18-85 that have elected to undergo or have undergone a minimally invasive "minimaze" surgery for the treatment of atrial firillation

Brief summary: The purpose of this study is to assess the efficacy of minimally invasive surgery for atrial fibrillation.

Detailed description: Patients who are undergoing or who have undergone minimally invasive surgery for atrial fibrillation will be followed prospectively. At 6 to 9 months, 1 and two years post surgery follow-up subjects will receive a trans-telephonic monitor to wear for approximately 1 month, and will submit transmissions on a daily basis. Episodes of atrial fibrillation will be documented during this time. The overall efficacy of the procedure will be assessed based on the freedom from atrial fibrillation at the time of transtelephonic monitoring.

Eligibility criteria: Inclusion Criteria:

* 18 or older
* paroxysmal, persistent, or permanent atrial fibrillation

Exclusion Criteria:

* concomitant heart surgery requiring open thoracotomy

Primary outcomes:
measure: Transtelephonic monitoring for the identification of post surgical Atrial Fibrillation
timeFrame: six months and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Division of Cardiology Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Kenneth A Ellenbogen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han FT, Kasirajan V, Kowalski M, Kiser R, Wolfe L, Kalahasty G, Shepard RK, Wood MA, Ellenbogen KA. Results of a minimally invasive surgical pulmonary vein isolation and ganglionic plexi ablation for atrial fibrillation: single-center experience with 12-month follow-up. Circ Arrhythm Electrophysiol. 2009 Aug;2(4):370-7. doi: 10.1161/CIRCEP.109.854828. Epub 2009 Jun 2.
citation: Han FT, Kasirajan V, Wood MA, Ellenbogen KA. Minimally invasive surgical atrial fibrillation ablation: patient selection and results. Heart Rhythm. 2009 Dec;6(12 Suppl):S71-6. doi: 10.1016/j.hrthm.2009.07.027. Epub 2009 Oct 24.
citation: Kasirajan V, Spradlin EA, Mormando TE, Medina AE, Ovadia P, Schwartzman DS, Gaines TE, Mumtaz MA, Downing SW, Ellenbogen KA. Minimally invasive surgery using bipolar radiofrequency energy is effective treatment for refractory atrial fibrillation. Ann Thorac Surg. 2012 May;93(5):1456-61. doi: 10.1016/j.athoracsur.2012.01.110.
Clinical trial NCT06073197: Comparison of Erector Spinae Block and Combined Deep and Superficial Serratus Anterior Plane Block
Official title: Comparision of the Effects of Ultrasound-guided Erector Spinae Block and Combined Deep and Superficial Serratus Anterior Plane Block on Perioperative Analgesia for Video-assisted Thoracoscopic Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Pain, Postoperative
Thoracic
Anesthesia
Keywords: serratus anterior plane block
video-assisted thoracoscopic surgery
erector spinae block
postoperative analgesia
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, controlled
Primary purpose: OTHER

Brief summary: Objective: The authors hypothesized that combined deep and superficial serratus anterior plane block (SAPB) is as effective as erector spinae plane block (ESPB) for intraoperative and postoperative analgesia for video-assisted thoracoscopic surgery.

Design: A prospective randomized controlled study. Participants: Adult patients undergoing elective video-assisted thoracoscopic surgery.

Interventions: Preoperative SAPB or ESPB implementation.

Detailed description: Plane blocks implemented on preoperative course on 35 patients for each group. Postoperative Visual Analogue Scale (VAS) scores (0-10), intraoperative and postoperative analgesic consumption was measured using Mann-Whitney test. In the postoperative phase, opioid side effects, complications related to plane blocks, mobilization time and length of hospital stay was recorded and measured.

Eligibility criteria: Inclusion Criteria:

* American Society of Anaesthesiologists (ASA) classification I-II scheduled for elective VATS

Exclusion Criteria:

* Patients who did not give consent
* Local anaesthetic allergy
* Known or suspected coagulopathy
* İnfection at the injection site
* History of thoracic surgery
* Severe cardiovascular disease
* Hepatic or renal insufficiency (glomerular filtration rate \<15 ml/min/1.73 m2)
* Severe neurological or psychiatric disorders
* Chronic opioid use

Primary outcomes:
measure: postoperative analgesic effects
timeFrame: first 48 hours
measure: intraoperative analgesic effects
timeFrame: intraoperative phase
Secondary outcomes:
measure: side effects
timeFrame: first 48 hours
measure: complications
timeFrame: first 48 hours
measure: mobilization
timeFrame: first 48 hours
measure: stay of hospital
timeFrame: first 4 days
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Uludag University
Study officials:
affiliation: Uludag University
name: seda cansabuncu
role: STUDY_CHAIR
References:
Clinical trial NCT05115097: AI Evaluation of COVID-19 Sounds (AI-EChOS)
Official title: AI Evaluation of COVID-19 Sounds
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
COVID-19 Respiratory Infection
Cough
Breathing Sound
Breathing, Mouth
Keywords: COVID-19
artificial intelligence
machine learning
sound
cough
breath
voice
diagnosis
automation
AI
ML
pneumonia
symptoms
airways
SARS-CoV-2
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants from the general population meeting the inclusion criteria will be included in three cohorts:

1. SARS-CoV-2 positive
2. SARS-CoV-2 negative but with respiratory disease
3. Healthy volunteers

Brief summary: In this study the investigators record sounds of voice, breaths and cough of subjects who tested positive for COVID19. The investigators then feed these sounds into an artificial intelligence and see if it can learn to recognise features to make COVID19 diagnosis from these sounds in order to avoid to use swabs to test the general population.


Eligibility criteria: Inclusion Criteria:

* Adults who tested positive for SARS-CoV-2 currently admitted to hospital at the study site
* Adults who tested negative for SARS-CoV-2 and are admitted for any respiratory condition (eg COPD or asthma flare-up, pneumonia..)
* Healthy volunteers

Exclusion Criteria:

* Patients under the age of 18.
* Patients unable to read in Italian.
* Patients unable to give informed consent to participate.
* Patients requiring life support (including, but not limited to, mechanical cardiac support, ventilation, etc.)
* Patients who are pregnant

Primary outcomes:
measure: Accuracy evaluation
timeFrame: September 2022-December 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: San Raffaele Hospital and Scientific Institute
state: (Mi)
Study officials:
affiliation: Vita-Salute San Raffaele University
name: Marco Montagna, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01524497: A Clinical Study of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression
Official title: A Clinical Study on Efficacy And Safety of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression A Multicenter, Randomized, Double-Blind, Parallel Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Depression
Keywords: losing interest and feelings of guilt
poor concentration
loss of appetite
suicide
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2012-02-02
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of trazodone hydrochloride prolonged-release tablets for treatment of depression in Chinese population.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 65, males and females, outpatients or inpatients;
2. Single episode or recurrent depression according to DSM-IV (Version 4) criteria;
3. Scores \> 18 on 17-item HAM-D at screening and baseline visits with a decrease not exceeding 20% between the two visits;
4. Symptoms of depression for at least 1 month;
5. Patients or their dependents/guardians providing signed informed consent forms.

Exclusion Criteria:

1. Serious suicide attempts (≥ 3 on item 3 'Suicide' of HAMD);
2. Depressive episode, with psychotic symptoms;
3. Refractory depression;
4. Depressive episode secondary to other mental or physical disorders;
5. Bipolar disorder;
6. Significant reduction in body weight and malnutrition induced by major depression;
7. Serious or unstable heart, hepatic, renal, endocrine and hematologic disease or malignant tumors;

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale-17 score
timeFrame: six weeks
Secondary outcomes:
measure: Changes in HAMA-14 score
timeFrame: Six weeks
measure: CGI-Severity of illness and CGI-Global improvement
timeFrame: Six weeks
measure: Changes in evaluation of sleep quality and sexual dysfunction
timeFrame: Six weeks
measure: Rate changes of responders/patients
timeFrame: Six weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Lee's Pharmaceutical company
name: Benjamin LI, Ph.D.
role: STUDY_DIRECTOR
References: