louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06320795: Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device
Official title: Studio Prospettico Per la Validazione Clinica Del Dispositivo Medico Indossabile Soundi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OSA
Lead sponsor: Biocubica srl
Sponsor class: INDUSTRY
First posted: 2024-03-20
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a pre-marketing, single-centre, prospective clinical trial with the aim of comparison the effectiveness and safety of the SOUNDI medical device compared to polysomnography in detecting parameters for the diagnosis of obstructive sleep apnea (OSA) syndrome in subjects with suspected diagnosis of sleep disorders.


Eligibility criteria: Inclusion Criteria:

* Patients who are able to understand the nature of the study and to give free informed consent
* Must be over 20 and referred by medical staff for an overnight assessment for suspected sleep apnea

Exclusion Criteria:

* Pregnancy
* Pacemaker wearer
* Allergies to any material of the device

Primary outcomes:
measure: To evaluate the accuracy of the clinical diagnosis of OSA
timeFrame: 6 Months
measure: To evaluate the agreement between the Apnea Hypopnea Index (AHI) from the home sleep study with SOUNDI and the home sleep study with polysomnography (PSG)
timeFrame: 6 Months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Day 1
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ambulatorio del Sonno- Istituto Auxologico Italiano IRCCS - Ospedale San Luca
Study officials:
affiliation: Istituo Auxologico Italiano
name: Carolina Lombardi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04849195: Comparison of Different Feature Engineering Methods for Automated ICD Coding
Official title: Comparison of Different Feature Engineering Methods for Automated ICD Coding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2021-04-19
Enrollment: 6947
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Admissions in Fuwai Hospital

Brief summary: Using traditional machine learning classifiers, this study targets on comparing bag-of-words, word2cec and roberta on automated ICD coding related to cardiovascular diseases in Chinese corpus.

Detailed description: ICD coding is quite important as it serves as basis for a wide range of economic and academic applications. Currently, manual coding is mainly adopted, which faces several limits like being time-consuming and prone to error, and this makes automated ICD coding via machine learning a hot research topic.

As an inevitable phase during machine learning, feature engineering plays a crucially important role in leading to promising coding performance. Although have reached enlightening conclusions, existing studies lacked comparison of different feature engineering methods. Finding out what methods under what circumstances perform better can be quite helpful in promoting practical applications of automated coding.

The investigators will implement this study based on inpatient' data collected from electronic medical records from Fuwai Hospital, the world's largest medical center for cardiovascular disease. Bag-of-words, word2cec and roberta will be respectively used to extracted features from training data. Then code-wise logistic regression classifiers and support vector machine classifiers will be trained to auto-assign codes. Afterwards, performances of the models on test data will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Admissions in Fuwai Hospital, from January 1, 2019, to February 28, 2019

Exclusion Criteria:

-

Primary outcomes:
measure: ICD-10 codes for each admission
timeFrame: At the end of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: China National Center for Cardiovascular Diseases
name: Wei Zhao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06158295: Effects of Walking Apnea at Low Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function
Official title: Effects of Walking Apnea at Low Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pain
Hypoxia
Hypercapnia
Apnea
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 60
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 aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent walking apneas training session at low lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.


Eligibility criteria: Inclusion Criteria:

- Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria:

* Cardiovascular, respiratory, metabolic, neurological or osteomuscular signs or pathologies.
* History of epilepsy.
* Pregnant
* Pharmacological treatment.
* Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 4 weeks.

Primary outcomes:
measure: Pain pressure threshold (PPT) on thumb, anterior tibial and spinous process of C7
timeFrame: before and after intervention (up 30 minutes)
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: before intervention (up 5 minutes)
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: before intervention (up 5 minutes)
measure: Global Physical Activity Questionnaire (GPAQ)
timeFrame: before intervention (up 5 minutes)
measure: Heart rate
timeFrame: during intervention (up 6 minutes)
measure: Oxygen saturation
timeFrame: during intervention (up 6 minutes)
measure: Blood pressure
timeFrame: before, during and after intervention (up 10 minutes)
measure: Rate of perceived exertion (RPE)
timeFrame: immediately after intervention (up 10 seconds)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU LaSalle
Study officials:
References:
Clinical trial NCT00004695: Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Variable Immunodeficiency
Keywords: common variable immunodeficiency
immunologic disorders and infectious disorders
primary immunodeficiency disease
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2000-02-25
Enrollment: 48
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can reduce the number of infections in patients with common variable immunodeficiency.

II. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment.

Detailed description: PROTOCOL OUTLINE: This is a randomized, open-label study. Patients are randomized to receive polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) or placebo.

Patients receive PEG-IL-2 or placebo by subcutaneous injection weekly for 18 months. Patients maintain a daily diary for 24 months.

Patients are followed every 4 months for 2 years.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Documented common variable immunodeficiency defined as a reduction of serum IgG by at least 2 standard deviations

In vitro lymphocyte proliferative response to PEG-IL-2 of at least 10 times more than unstimulated cultures

--Prior/Concurrent Therapy--

No biologic response modifier therapy (i.e., interferon, cyclosporin A) except prednisone (maximum 10 mg/day)

Concurrent treatment with same dosage intravenous gamma-globulin for at least 6 months is required

--Patient Characteristics--

Life expectancy: At least 24 months

Other: Not pregnant or nursing HIV negative

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Charlotte Cunningham-Rundles
role: STUDY_CHAIR
References:
Clinical trial NCT02812095: Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy
Official title: Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enterostomy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 20
Sex: ALL
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Refeeding is an extracorporeal stool transport from the proximal stoma end to the distal end of stoma. Refeeding may be beneficial in preventing malabsorption, electrolyte imbalance, cholestasis and atrophy of the distal intestine. Investigators are focused on evaluating the efficacy and safety of the practice of refeeding in preterm infants with enterostomy. Clinical data including weight gain, total parenteral nutrition (TPN) usage, and other laboratory findings will be collected. Serial citrulline levels during refeeding procedure and pathologic specimens of bowel (at the time of stoma closure) will be collected for evaluating bowel adaptation.


Eligibility criteria: Inclusion Criteria:

* Preterm infants who are less than 35 weeks gestational age at birth and get stomas after laparotomy

Exclusion Criteria:

* Congenital gastrointestinal malformation
* Blind pouch (after laparotomy)
* Refeeding procedure related infection
* Hemodynamic instability requiring inotropic or vasopressor agents (if the condition improves, the refeeding procedure can be restarted again)

Primary outcomes:
measure: The change of citrulline level during the study period
timeFrame: up to 6 months of corrected age
Secondary outcomes:
measure: The pathologic findings after refeeding procedure
timeFrame: up to 8 weeks of corrected age
measure: the number of days on parenteral nutrition
timeFrame: up to 8 weeks of corrected age
measure: The weight gain
timeFrame: up to 6 months of corrected age
measure: Adverse events during refeeding procedure
timeFrame: up to 8 weeks of corrected age
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00206895: Photodynamic Therapy of Acne Vulgaris - a Randomized Blinded Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluated the efficacy and tolerability of methyl aminolevulinate and 5-aminolevulinic acid photodynamic therapy in patients with moderate to severe facial acne vulgaris in a randomized controlled and investigator blinded trial.


Eligibility criteria: Inclusion Criteria:18 years or older, good health, more than 12 inflammatory facial acne lesions -

Exclusion Criteria:skin type VI, pregnant or lactating woman. Oral retinoid use within one year, systemic antibiotics within 1 month, topical acne treatment within 2 weeks.

-

Primary outcomes:
measure: Lesion counts (non-inflammatory and inflammatory)
measure: Leeds Revised Acne Grading System
Secondary outcomes:
measure: Pain
measure: Side effects
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen NV
Study officials:
affiliation: Bispebjerg Hospital
name: Hans Christian Wulf, MD, Sci
role: STUDY_DIRECTOR
References:
Clinical trial NCT02831595: Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Knee Arthritis
Lead sponsor: Permedica spa
Sponsor class: INDUSTRY
First posted: 2016-07-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of knee osteoarthritis scheduled for unilateral TKA

Brief summary: Modern knee implants combine several types of metal and therefore potentially expose patients to different metal ions.

Titanium niobium nitride coating (TiNbN) acts like a physical barrier against the corrosion process and the metallic ions release towards the surrounding biologic environment, thus, making TiNbN-coated prostheses possible to be safety implanted in metal sensitized patients.

The aim of the study is to verify that the postoperative plasma metal concentrations at 1 year are not different than preoperative values.


Eligibility criteria: Inclusion Criteria:

* Patients candidate for unilateral primary total knee arthroplasty

Exclusion Criteria:

* Existing orthopaedic metal implants
* A history of hypersensitivity to metals
* Preoperative patch-test positivity to Co, Cr, Ni and Ti
* Malignancies
* Renal insufficiency
* Severe illnesses that would impair participation in this study

Primary outcomes:
measure: Change from baseline plasma metal ion concentrations (Co, Cr, Ni) at 12 months
timeFrame: Preoperative and at 12 months follow-up
Secondary outcomes:
measure: Number of patients with metal sensitivity at 1 year tested by patch-testing
timeFrame: 1 year follow-up
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Istituto Ortopedico Galeazzi Milano, Italy
name: Nicola Ursino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05678595: The Effect of High-intensity Laser Therapy in Patients With Carpal Tunnel Syndrome.
Official title: The Effect of High-intensity Laser Therapy on Pain, Functional Status, Hand Grip Strength and Median Nerve Cross-sectional Area in Ultrasonography in Patients With Carpal Tunnel Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: pain
High-intensity laser therapy
ultrasonography
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effects of high intensity laser therapy (HILT) on pain, functional status, hand grip strength and median nerve cross-sectional area in ultrasonography in patients with carpal tunnel syndrome.

Detailed description: Patients who are admitted and diagnosed with carpal tunnel syndrome based on anamnesis, physical examination and electromyography are included in the study.

Eligibility criteria: Inclusion Criteria:

1. Electrophysiologically mild or moderate CTS
2. Patients who are literate and able to understand verbal instructions in our

Exclusion Criteria:

1. Diabetes
2. Systemic disorders that may affect treatment such as hypothyroidism, SLE, gout
3. History of polyneuropathy, cervical radiculopathy, brachial plexopathy
4. Injection for the carpal tunnel in the last 1 month
5. History of severe trauma, fracture, operation to both upper extremities at any time
6. Malignancy or history of malignancy
7. Renal failure
8. Peripheral or central nervous system diseases
9. Pregnancy
10. History of physical therapy program for the same hand wrist in the last months.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Change from baseline in pain on the VAS at week 2 and week 12 [ Time Frame: Baseline-Week 2- Week 12 ]
Secondary outcomes:
measure: Boston Carpal Tunnel Questionnaire
timeFrame: Change from baseline in pain and disability on the Boston Carpal Tunnel Questionnaire at week 2 and 12.
measure: Hand Grip Force Measurement Test
timeFrame: Baseline- week 2- week 12
measure: The cross-sectional area of the median nerve
timeFrame: Change from baseline in the cross-sectional area of the median nerve at week 2 and week 12.
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Banu Ordahan
Study officials:
affiliation: Meram Medical School, Necmettin Erbakan University, Konya, Turkey
name: BANU ORDAHAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05237895: Serum Endocan Levels and Gestational Diabetes
Official title: Evaluation of Serum Endocan Levels in Patients With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Endocan
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2022-02-14
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In diabetic patients, serum endocan level has been significantly increased in patients and the levels on the long-term complications are correlated. Based on the Iinformation obtained from these studies, it can be said that there is a strong association between diabetes and serum endocan levels.

Detailed description: It has been shown that endocan level of plasental tissue in gestational diabtes patients is significantly increased when looking at the same week compared with plasenta tissue samples of helathy pregnancy. From the information obtained from these studies, it can be said that there is a strong association between diabetes mellitus and serum endocan levels. investigators aimed to determine the relationship between serum endocan levels and gestational diabetes in the study.

Eligibility criteria: Inclusion Criteria:

* being pregnant at 24-26 weeks of gestation
* having oral glucose toleranse screening test
* age between 18-45 years

Exclusion Criteria:

* having in utero mort fetus
* having a previous diagnosis of diabetes
* having a multiple pregnancy
* having a coronary artery disease
* having preeclampcia
* having a pregnancy obtained by assisted reproductive technology
* using cigarette
* using alcohol

Primary outcomes:
measure: Detection of diagnostic value of serum endocan levels in patient with gestational diabetes
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpaşa Treh
state: Gaziosmanpaşa
Study officials:
affiliation: Gaziosmanpasa Research and Education Hospital
name: elif yıldız, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04149795: Physical Activity Recommendation Behaviour in German Psychologists
Official title: Physical Activity Recommendation Behaviour in German Psychologists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Disorder
Physical Activity
Keywords: Physical activity
Mental disorder
Recommendation behaviour
Prescription Behaviour
Mental health
Exercise
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 454
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical psychologists that currently work with patients with mental disorders in Germany.

Brief summary: The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German psychologists working with patients with mental disorders.

Detailed description: Physical activity plays an important role in the prevention and treatment of mental disorders. Despite the potential mental health benefits, large proportions of patients with mental disorders do not meet the physical activity recommendations.

Clinical psychologists play a key role in the recommendation of physical activity to their patients. There are no previous studies that examine physical activity recommendation behaviour in German psychologists.

The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German psychologists working with patients with mental disorders.

Eligibility criteria: Inclusion Criteria:

* Clinical psychologist
* Currently working with patients with mental disorders
* At least 18 years old
* Sufficient German skills for answering the questionnaire

Exclusion Criteria:

None

Primary outcomes:
measure: Exercise in Mental Illness Questionnaire (EMIQ) - German Version
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin - Department for Psychiatry and Psychotherapy - Charité Campus Mitte
Study officials:
affiliation: Charité Universitätsmedizin Berlin- Charité Campus Mitte - Department for Psychiatry and Psychotherapy
name: Moritz B Petzold, Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
References: